WO2025117876A1 - Skin treatment systems, devices, and methods - Google Patents
Skin treatment systems, devices, and methods Download PDFInfo
- Publication number
- WO2025117876A1 WO2025117876A1 PCT/US2024/057944 US2024057944W WO2025117876A1 WO 2025117876 A1 WO2025117876 A1 WO 2025117876A1 US 2024057944 W US2024057944 W US 2024057944W WO 2025117876 A1 WO2025117876 A1 WO 2025117876A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- patient
- data
- microcoring
- clinician
- procedure
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/20—Surgical instruments, devices or methods for vaccinating or cleaning the skin previous to the vaccination
- A61B17/205—Vaccinating by means of needles or other puncturing devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1477—Needle-like probes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00747—Dermatology
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00452—Skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0076—Tattooing apparatus
Definitions
- a system for performing a cosmetic procedure on multiple patients comprises at least one microcoring subsystem.
- Each microcoring subsystem comprising at least one treatment device.
- Each treatment device comprising a set of multiple treatment modules.
- Each treatment module comprising one or more coring elements.
- the system further comprises at least one actuation assembly configured to operably attach to a treatment module and configured to perform a microcoring Docket No. CYT-014-PCT procedure comprising the treatment module translating in a series of reciprocating motions.
- Each reciprocating motion comprises each coring element being inserted into and withdrawn from tissue of a patient.
- the at least one microcoring subsystem comprises a first microcoring subsystem located at a first clinical location and a second microcoring subsystem located at a second clinical location different than the first clinical location.
- the first microcoring subsystem can comprise a first set of devices comprising multiple patient devices, multiple clinician devices, and/or multiple vendor devices in communication with the first microcoring subsystem and the second microcoring subsystem can comprise a second set of devices comprising multiple patient devices, multiple clinician devices, and/or multiple vendor devices in communication with the second microcoring subsystem.
- the at least one treatment device comprises two or more treatment devices.
- the system further comprises a network and/or a server, and the network and/or server is configured to receive data from each microcoring subsystem of the at least one microcoring subsystem.
- the system further comprises: at least one patient device; at least one clinician device; and/or at least one vendor device.
- each microcoring subsystem of the at least one microcoring subsystem comprises one, two, or more components selected from the group consisting of: at least one console; at least one imaging device; at least one implant; at least one tissue collection assembly; and combinations thereof.
- the microcoring procedure is configured to provide a cosmetic effect to the patient.
- the series of reciprocating motions comprises at least one reciprocating motion.
- the series of reciprocating motions can comprise at least two reciprocating motions.
- the actuation assembly is further configured to translate the treatment module in one or more directions relative to a surface of skin tissue of the patient.
- the system is configured to perform the series of reciprocating motions based on one, two, or more reciprocating motion parameters.
- the system further comprises a patient device that includes a patient app.
- the patient device can comprise one, two, or more devices selected from the group consisting of: phone; cell phone; smart phone; computer; laptop computer; tablet Docket No. CYT-014-PCT computer; automobile communication device; a patient-monitoring device; and combinations thereof.
- the patient device can comprise at least one patient-monitoring device.
- the at least one patient-monitoring device can comprise one, two, or more devices selected from the group consisting of: camera or camera system; exercise monitoring device; sleep monitoring device; sleep apnea monitoring device; EKG and/or other heart monitoring device; EEG and/or other brain monitoring device; blood pressure monitoring device; blood glucose- monitoring device; other health-monitoring device; a patient location device; and combinations thereof.
- the patient device can be configured for multiple modes of operation.
- the multiple modes of operation can comprise different levels of complexity.
- the multiple modes of operation can comprise different levels of involvement of two or more of the multiple patients.
- the multiple modes of operation can comprise a parent-guardian mode of operation.
- the patient device can be configured to provide information to a patient.
- the system can be configured to receive patient parameter data and the information provided to the patient is customized based on the patient parameter data.
- the patient parameter data can comprise patient location data.
- the patient parameter data can comprise: patient image data; patient lifestyle data; patient medical history data; age data; race data; sex data; weight data; body mass index data; skin quality and/or other skin characterization data; patient health data; patient allergy data; data related to a previous microcoring procedure; data related to a previous surgical and/or other clinical procedure; DNA and/or other genetic data; data related to medications taken by the patient; patient diet data; patient location data; patient travel data; patient occupation data; and/or patient financial data.
- the patient parameter data can comprise data related to one or more clinicians in relative proximity to the home or other associated location of the patient.
- the patient parameter data can comprise data related to one or more drug stores in relative proximity to the home or other associated location of the patient.
- the information provided to the patient can comprise microcoring procedure education information.
- the information provided to the patient can comprise post- microcoring procedure information.
- the information provided to the patient can comprise information related to applying sunscreen or other topical agent, taking a medication, or both.
- the information provided to the patient can comprise information related to a future appointment of the patient with a clinician.
- the patient device can be configured to record patient data.
- the patient data recorded can comprise: age data; race data; sex data; weight data; body mass index data; skin quality and/or other skin characterization data; patient health data; patient allergy data; data related to a previous microcoring procedure; data related to a previous surgical and/or other clinical procedure; DNA and/or other genetic data; data related Docket No. CYT-014-PCT to medications taken by the patient; patient diet data; patient location data; patient travel data; patient occupation data; and/or patient financial data.
- the system can be configured to accept the patient data from multiple data sources.
- the patient data can comprise data collected after the performance of a microcoring procedure.
- the system can be configured to provide the patient data to a clinician of the patient.
- the system can be configured to provide the patient data to a cosmetic community.
- the patient device can be configured to provide a “refer-a-friend” function.
- the system can be configured to provide a patient with a discount for each future patient recommended by the patient.
- the patient device can be configured to provide a patient interface to one or more social media platforms.
- the system further comprises a clinician device that includes a clinician app.
- the clinician device can comprise one, two, or more devices selected from the group consisting of: phone; cell phone; smart phone; computer; laptop computer; tablet computer; automobile communication device; a patient-monitoring device; and combinations thereof.
- the clinician device can be configured for multiple modes of operation.
- the clinician device can be configured to be used by multiple clinicians, and a first mode of operation can be configured for use by a first clinician and a second mode of operation can be configured for use by a second clinician.
- the clinician device can be configured to provide a clinician advertising function.
- the clinician device can be configured to receive summary data reports.
- the system further comprises a vendor device that includes a vendor app.
- the vendor device can be configured to provide an advertising access function.
- the system further comprises a controller and a memory storage component coupled to the controller, and the memory storage component stores instructions for the controller to perform an algorithm, and the algorithm is configured to provide an algorithm output.
- the algorithm can comprise an artificial intelligence algorithm.
- the algorithm can provide the algorithm output based on images of a patient.
- the system can be configured to record patient data, clinician data, and/or vendor data, and the algorithm can provide the algorithm output based on one, two, or three of: patient data; clinician data; and/or vendor data.
- the system can be configured to record patient data, and the algorithm can provide the algorithm output based on patient data selected from the group consisting of: age data; race data; sex data; weight data; body mass index data; skin quality and/or other skin characterization data; patient health data; patient allergy data; data related to a previous microcoring procedure; data related to a previous surgical and/or other clinical procedure; Docket No.
- the algorithm can be adjustable.
- the algorithm can be configured to be adjusted by a clinician.
- the system can be configured to record patient data, and the algorithm can be configured to manipulate and/or otherwise analyze the patient data and predict a potential outcome of the microcoring procedure.
- the patient data can comprise patient data recorded from a camera.
- the system can be configured to record patient data, and the algorithm can be configured to analyze the patient data and profile and/or identify one or more patients that are predicted to have a desired outcome of the microcoring procedure.
- the system can be configured to record patient data, and the algorithm can be configured to identify patients with similar demographic and/or clinical profiles.
- the system can be configured to share outcomes achieved by other patients with similar profiles.
- the system is configured to operate in a clinician link mode in which the system produces clinician-linked information, and the clinician-linked information is related to a particular clinician.
- the clinician-linked information output by the system can comprise data provided to a patient that is based on a clinician of the patient.
- the clinician-linked information output by the system can comprise patient data provided to a clinician of a patient, and the patient data can be provided prior to a microcoring procedure.
- the system is configured to allow a patient to enter the parameters of a desired microcoring procedure.
- the system can be further configured to provide an assessment of the applicability of the desired microcoring procedure.
- the system is configured to provide a predicted outcome of a proposed microcoring procedure on a patient.
- the predicted outcome can comprise predicted images of the patient that comprise estimations of the patient’s skin sometime after the microcoring procedure is performed.
- the predicted images can be based on patient provided images.
- the system is configured to provide a prediction of patient satisfaction that will result after the performance of a microcoring procedure.
- the system is configured to advertise a promotional event.
- the advertising can comprise advertising provided via a group email and/or information provided on a social medial platform.
- the system is configured to perform data harvesting related to data produced in one or more microcoring procedures performed by the system.
- the data harvesting can be configured to produce harvested data
- the system can be configured to Docket No. CYT-014-PCT sell the harvested data.
- the system can be configured to sell the harvested data to vendors that sell cosmetic products.
- the system can be configured to sell the harvested data to vendors that have similar customers to the customers that buy the system. The similarity between the similar customers can be an income level of each customer.
- the system is configured to collect patient data and to perform and/or assist in the performance of a registry study.
- the system is configured to notify patients who have received a microcoring procedure performed using the system of an additional procedure that could be performed.
- the additional procedure can comprise an additional microcoring procedure performed using the system.
- the additional procedure can comprise a procedure performed using a product of a partner of the manufacturer of the system.
- the system is configured to request and/or receive potential customer data.
- the potential customer data can comprise data from vendors who sell cosmetic products.
- the potential customer data can comprise data from vendors who have similar customers to the customers of the manufacturer of the system.
- the system is configured to produce summary data reports.
- the system is configured to upload IOT data (“internet of things” data).
- the IOT data can be provided by a system component, such as the at least one treatment device.
- the IOT data can be provided by a non-system device.
- the IOT data can comprise microcoring treatment procedure data.
- the system can be configured to analyze the IOT data and produce an IOT analysis.
- the system can comprise a patient device including a patient app, and the system can be configured to modify the patient app based on the IOT analysis.
- the system can comprise a clinician device including a clinician app, and the system can be configured to modify the clinician app based on the IOT analysis.
- the system can comprise a vendor device including a vendor app, and the system can be configured to modify the vendor app based on the IOT analysis.
- the system can be configured to modify the at least one treatment device based on the IOT analysis.
- the system can be configured to modify one or more settings used in a microcoring treatment procedure.
- the system can be configured to produce information to send to a patient, and the produced information can be based on the IOT analysis.
- the system can be configured to perform a microcoring procedure based on the uploaded IOT data.
- the system can be configured to perform a microcoring procedure in a closed loop arrangement based on the uploaded IOT data.
- the system can be configured to receive images of a patient prior to the performance of a microcoring procedure on the patient. Docket No. CYT-014-PCT [081]
- the system further comprises a camera configured to collect the pre-procedure patient images.
- the system can comprise a patient device including a camera configured to collect the pre-procedure patient images.
- the system can be further configured to produce a treatment plan based on the pre-procedure patient images.
- the treatment plan can comprise proposed skin locations to be treated.
- the system can be further configured to identity potential treatment issues based on the pre-procedure patient images.
- the system can be configured to search for the pre-procedure patient images.
- the system can be configured to search one or more social media sites for the pre-procedure patient images.
- the system is configured to receive images of a patient after the performance of a microcoring procedure on the patient.
- the system can be further configured to monitor for an adverse condition based on the post-procedure patient images.
- the system can be further configured to produce a post-microcoring procedure treatment plan and to monitor and suggest a change in the post-microcoring procedure treatment plan based on the post-procedure patient images.
- the system can be configured to search for the post- procedure patient images.
- the system can be configured to search one or more social media sites for the post-procedure patient images.
- the system is configured to provide to the patient with a pre-microcoring procedure recommendation plan.
- the pre-microcoring recommendation plan can be configured to optimize the outcome of a microcoring procedure for the patient.
- the pre-microcoring recommendation plan can be based on one or more patient images.
- the system can be configured to automatically send out the pre-microcoring recommendation plan based on a schedule.
- the system can be further configured to continue to send the pre- microcoring recommendation plan until a confirmation of receipt from the patient is received.
- the pre-microcoring recommendation plan can comprise a recommended use of one or more cosmetic products.
- the system can be configured to provide an automated web link to buy the one or more cosmetic products. The selection of the one or more cosmetic products can be based on an input of a clinician.
- the system is configured to send a patient a post- microcoring procedure recommendation plan for that patient.
- the post-microcoring recommendation plan can be configured to optimize the outcome of a microcoring procedure for the patient.
- the post-microcoring recommendation plan can be based on one or more patient images.
- the patient images can comprise pre and/or post microcoring procedure patient images.
- the patient images can comprise pre and post microcoring procedure patient images.
- the system can be further configured to continue to send the post-microcoring Docket No. CYT-014-PCT recommendation plan until a confirmation of receipt from the patient is received.
- the post- microcoring recommendation plan can comprise a recommended use of one or more cosmetic products.
- the system can be configured to provide an automated web link to buy the one or more cosmetic products. The selection of the one or more cosmetic products can be based on an input of a clinician.
- the system is configured to monitor patient browsing and produce browsing data.
- the system can be further configured to produce a recommendation of a microcoring procedure based on the browsing data.
- the system can be further configured to produce a recommendation of a complementary procedure to be performed based on the browsing data.
- the system can be further configured to recommend the purchase of a third-party product based on the browsing data.
- the system can be further configured to recommend a clinician product and/or procedure based on the browsing data.
- the system comprises a member clinician login function.
- the system can comprise one or more devices that can be modified based on use by a first clinician that has logged into the member clinician function. The modifications can comprise a bias toward preferences of the first clinician.
- the clinician login function can comprise multiple levels of membership. The multiple levels of membership can be related to multiple levels of preferences.
- the system is configured to provide one or more recommendations to a clinician.
- the one or more recommendations can comprise at least one recommendation to increase patient throughput for a clinician.
- the system is configured to provide a discount to a patient, a clinician, and/or a vendor.
- the system can be configured to provide the discount based on the patient scheduling an appointment within a pre-determined timeframe.
- the system can be configured to provide the discount based on the patient referring another patient.
- the system can be configured to receive a payment from a patient, a clinician, and/or a vendor.
- the system is configured to make a payment to a clinician, a vendor, and/or a patient.
- the system is configured to receive a payment from a vendor based on a product of that vendor being sold.
- the system is configured to provide treatment data to a receiving component of the system and/or and the system is configured to receive treatment data from a transmitting component of the system.
- the receiving component and/or the Docket No. CYT-014-PCT transmitting component can comprise one, two, or more devices selected from the group consisting of: one or more patient devices; one or more clinician devices; one or more vendor devices; and combinations thereof.
- the system can be further configured to identify one or more of: movement of the at least one treatment device relative to the patient’s anatomy; smoothness of at least one treatment device movement; and/or detection of the at least one treatment device treating the same anatomical location of the patient.
- the system can be configured to: collect movement, position, and/or other data across multiple operators of the system; calculate population analytics to determine and identify operators that achieve and/or are likely to achieve optimized outcomes; and/or compare operator technique data of multiple operators such as to compare operators.
- the system is configured to share data with one or more of: a clinician; a patient; a parent of a patient; and/or an information portal.
- the system is configured to create one or more of: a community event; a training workshop such as an online training workshop; a consult, such as a virtual consult; and/or a virtual event.
- the system is configured to offer post-operative care via an online marketplace.
- the system can be configured to function as a broker between vendors, physicians, and/or patients.
- the system can be configured to sell one or more add-on products to a patient.
- the system is configured to allow a patient and/or other user of the system to transfer patient data to a social media platform.
- the system is configured to provide social media platform information to a patient or other user.
- the system is configured to allow a clinician and/or a vendor to create advertising materials.
- the system can further comprise a patient device, a server, and/or a network, and the system can be further configured to transmit the advertising materials to the patient device, the server, and/or the network.
- the system can be configured to post the advertising materials on the patient device, on television and/or radio, and/or on a website.
- the system is configured to provide references regarding one or more patients identified by the system as potential candidates for a microcoring or other procedure performed using the system. The one or more patients identified by the system can be identified based on a prediction performed by the system that indicates the one Docket No.
- the system is configured to create and/or provide advertising of a promotional event and/or other event, and the promotional event and/or other event is associated with the use of the system.
- the system can be configured to perform a function selected from the group consisting of: send a group email; provide information to a social media platform; provide information on a patient device, a clinician device, and/or a vendor device; and combinations thereof.
- the system can be configured to organize and/or otherwise cause to occur: one or more virtual events; one or more live events; or both.
- the system is configured to allow a patient to enter a desired procedure into memory of the system, and the system is further configured to provide feedback to the patient.
- the feedback provided can comprise: one or more system created predicted images of the patient approximating the appearance of the patient after the desired procedure can be performed; an assessment of the appropriateness of the desired procedure for the patient; one or more alternative suggested procedures; and/or combinations of these.
- the system can be configured to produce a three-dimensional selfie representing the current condition of the patient, and/or representing a predicted outcome of a microcoring, and/or other procedure performed on that patient using the system.
- the system can produce the three-dimensional selfie by stitching multiple two-dimensional images, using augmented reality, or both.
- the system is configured to provide a clinician suggestion to a patient, and the clinician suggestion comprises a recommendation of a particular clinician type or a particular clinician.
- the system can determine the clinician suggestion based on patient data and/or clinician data.
- the patient data and/or clinician data can comprise data selected from the group consisting of: patient images; patient desired outcomes data; patient physiologic data; patient location data; patient demographic data; patient financial data; clinician performance data; clinician skill level data; clinician office location data; clinician available techniques and/or equipment data; and combinations thereof.
- the system can be configured to determine the clinician suggestion based on an analysis of a set of multiple clinicians, and the analysis identifies clinicians that have treated the highest quantity of similar profile patients.
- the system is configured to harvest data to perform a registry study.
- the system can be configured to reduce the complexity of the patient- consenting process.
- the system can be configured to support and/or enhance enrollment of Docket No. CYT-014-PCT patients from multiple clinical practices into a multi-site study.
- the system can be configured to provide collaborative clinical study tools.
- the system can be configured to provide an automated creation of documents for submittal to an internal review board.
- the at least one treatment device further comprises a functional element comprising: one or more sensors; one or more transducers; and/or one or more other components.
- the functional element can comprise one or more transducers configured to provide tactile feedback to an operator.
- the tactile feedback can be configured to cause the operator to better hold and/or better position the at least one treatment device during microcoring.
- the functional element can further comprise one or more accelerometers and/or one or more other sensors configured to track movement and/or position of the at least one treatment device.
- the system further comprises a skin modification device.
- the skin modification device can comprise one, two, or more products selected from the group consisting of: hyaluronic acid; a moisturizer; an analgesic; a peptide; exosomes; platelet-rich plasma (PRP); arnica montana extract; a vasoconstrictor; methotrexate; minoxidil; stem cells; botulinum toxin; a corticosteroid; and combinations thereof.
- Fig.1 illustrates a block diagram of a system for treating and/or diagnosing tissue, consistent with the present inventive concepts.
- Fig.2 illustrates a side view of a coring element being introduced into the skin, consistent with the present inventive concepts. Docket No. CYT-014-PCT
- Fig.3A illustrates an end view of a needle, consistent with the present inventive concepts.
- Figs.3B and 3C illustrate a side view of a needle, consistent with the present inventive concepts.
- Fig.3D illustrates a sectional view of a needle, consistent with the present inventive concepts.
- Fig.4 illustrates a block diagram of a system for treating and/or diagnosing tissue, consistent with the present inventive concepts.
- DETAILED DESCRIPTION OF THE DRAWINGS [114] Reference will now be made in detail to the present embodiments of the systems, devices, and methods (singly or collectively “technology” or “technologies” herein), examples of which are illustrated in the accompanying drawings. Similar reference numbers may be used to refer to similar components. However, the description is not intended to limit the present disclosure to particular embodiments, and it should be construed as including various modifications, equivalents, and/or alternatives of the embodiments described herein.
- first element when referred to as being “in”, “on” and/or “within” a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g., within a wall of the second element); positioned on an external and/or internal surface of the second element; and combinations of two or more of these.
- Docket No. CYT-014-PCT [122]
- proximate when used to describe proximity of a first component or location to a second component or location, is to be taken to include one or more locations near to the second component or location, as well as locations in, on and/or within the second component or location.
- a component positioned proximate an anatomical site shall include components positioned near to the anatomical site, as well as components positioned in, on and/or within the anatomical site.
- Spatially relative terms such as “beneath,” “below,” “lower,” “above,” “upper” and the like may be used to describe an element and/or feature's relationship to another element(s) and/or feature(s) as, for example, illustrated in the figures. It will be further understood that the spatially relative terms are intended to encompass different orientations of the device in use and/or operation in addition to the orientation depicted in the figures.
- the terms “prevent”, “preventing”, “prevention” and the like, where used herein, shall include the acts of “reduce”, “reducing”, and “reduction”, respectively.
- the term “and/or” where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other.
- a and/or B is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.
- the term “one or more”, where used herein can mean one, two, three, four, five, six, seven, eight, nine, ten, or more, up to any number.
- a component, process, and/or other item selected from the group consisting of: A; B; C; and combinations thereof shall include a set of one or more components that comprise: one, two, three or more of item A; one, two, three or more of item B; and/or one, two, three, or more of item C.
- “and” can mean “or”, and “or” can mean “and”. For example, if a feature is described as having A, B, or C, the feature Docket No.
- CYT-014-PCT can have A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, the feature can have only one or two of A, B, or C.
- the expression “configured (or set) to” used in the present disclosure may be used interchangeably with, for example, the expressions “suitable for”, “having the capacity to”, “designed to”, “adapted to”, “made to” and “capable of” according to a situation.
- the expression “configured (or set) to” does not mean only “specifically designed to” in hardware. Alternatively, in some situations, the expression “a device configured to” may mean that the device “can” operate together with another device or component.
- threshold refers to a maximum level, a minimum level, and/or range of values correlating to a desired or undesired state.
- a system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and/or outside a threshold range of values, such as to cause a desired effect (e.g., efficacious therapy) and/or to prevent or otherwise reduce (hereinafter “prevent”) an undesired event (e.g., a device and/or procedural adverse event).
- a system parameter is maintained above a first threshold (e.g., above a first temperature threshold to cause a desired therapeutic effect to tissue) and below a second threshold (e.g., below a second temperature threshold to prevent undesired tissue damage).
- a threshold value is determined to include a safety margin, such as to account for patient variability, system variability, tolerances, and the like.
- “exceeding a threshold” relates to a parameter going above a maximum threshold, below a minimum threshold, within a range of threshold values and/or outside of a range of threshold values.
- room pressure shall mean pressure of the environment surrounding the systems and devices of the present inventive concepts.
- “Positive pressure” includes pressure above room pressure or simply a pressure that is greater than another pressure, such as a positive differential pressure across a fluid pathway component such as a valve. “Negative pressure” includes pressure below room pressure or a pressure that is less than another pressure, such as a negative differential pressure across a fluid component pathway such as a valve. Negative pressure can include a vacuum but does not imply a pressure below a vacuum. As used herein, the term “vacuum” can be used to refer to a full or partial vacuum, or any negative pressure as described hereinabove. [132] The term “diameter” where used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described.
- the Docket No. CYT-014-PCT term “diameter” shall be taken to represent the diameter of a hypothetical circle with the same cross-sectional area as the cross section of the component being described.
- the terms “major axis” and “minor axis” of a component where used herein are the length and diameter, respectively, of the smallest volume hypothetical cylinder which can completely surround the component.
- the term “fluid” can refer to a liquid, gas, gel, or any flowable material, such as a material which can be propelled through a lumen and/or opening.
- the term “material” can refer to a single material, or a combination of two, three, four, or more materials.
- the term “conduit” or “conduits” can refer to an elongate component that can include one or more flexible and/or non-flexible filaments selected from the group consisting of: one, two or more wires or other electrical conductors (e.g., including an outer insulator); one, two or more wave guides; one, two or more hollow tubes, such as hydraulic, pneumatic, and/or other fluid delivery tubes; one or more optical fibers; one, two or more control cables and/or other mechanical linkages; one, two or more flex circuits; and combinations of these.
- a conduit can include a tube including multiple conduits positioned within the tube.
- a conduit can be configured to electrically, fluidically, sonically, optically, mechanically, and/or otherwise operably connect one component to another component.
- the term “transducer” is to be taken to include any component or combination of components that receives energy or any input and produces an output.
- a transducer can include an electrode that receives electrical energy and distributes the electrical energy to tissue (e.g., based on the size of the electrode).
- a transducer converts an electrical signal into any output, such as: light (e.g., a transducer comprising a light emitting diode or light bulb); sound (e.g., a transducer comprising one or more piezoelectric and/or CMUT transducers configured to deliver and/or receive ultrasound energy); pressure (e.g., an applied pressure or force); heat energy; cryogenic energy; chemical energy; mechanical energy (e.g., a transducer comprising a motor or a solenoid); magnetic energy; and/or a different electrical signal (e.g., different than the input signal to the transducer).
- light e.g., a transducer comprising a light emitting diode or light bulb
- sound e.g., a transducer comprising one or more piezoelectric and/or CMUT transducers configured to deliver and/or receive ultrasound energy
- pressure e.g., an applied pressure or force
- heat energy e.g., an applied pressure
- a transducer can convert a physical quantity (e.g., variations in a physical quantity) into an electrical signal.
- a transducer can include any component that delivers energy and/or an agent to tissue, such as a transducer configured to deliver one or more of: heat energy to tissue; cryogenic energy to tissue; electrical energy to tissue (e.g., a transducer comprising one or more electrodes); light energy to tissue (e.g., a transducer comprising a laser, light emitting diode and/or optical Docket No.
- CYT-014-PCT component such as a lens or prism
- mechanical energy to tissue e.g., a transducer comprising a tissue manipulating element
- sound energy to tissue e.g., a transducer comprising one or more piezoelectric and/or CMUT transducers
- chemical energy e.g., a transducer comprising one or more piezoelectric and/or CMUT transducers
- chemical energy e.g., electromagnetic energy to tissue
- magnetic energy e.g., a transducer comprising one or more piezoelectric and/or CMUT transducers
- chemical energy e.g., electromagnetic energy to tissue
- magnetic energy e.g., a transducer comprising one or more piezoelectric and/or CMUT transducers
- chemical energy e.g., a transducer comprising one or more piezoelectric and/or CMUT transducers
- chemical energy e.g., a transducer comprising
- a functional element can comprise one or more sensors and/or one or more transducers.
- a functional element is configured to deliver energy to tissue, such as to treat and/or image tissue.
- a functional element comprises one or more hollow filaments (e.g., one or more needles) that are configured to be inserted into tissue and/or withdrawn from tissue, such as to perform a microcoring treatment as described herein.
- a functional element e.g., comprising one or more sensors
- a sensor or other functional element is configured to perform a diagnostic function (e.g., to gather data used to perform a diagnosis).
- a functional element is configured to perform a therapeutic function (e.g., perform a microcoring procedure, deliver therapeutic energy, and/or deliver a therapeutic agent).
- a functional element comprises one or more elements constructed and arranged to perform a function selected from the group consisting of: core and/or remove tissue; deliver energy; extract energy (e.g., to cool a component); deliver a drug or other agent; manipulate a system component or patient tissue; record or otherwise sense a parameter such as a patient physiologic parameter or a patient anatomical parameter; and combinations of two or more of these.
- a “functional assembly” can comprise an assembly constructed and arranged to perform a function, such as are described hereinabove.
- a functional assembly is configured to core tissue and/or otherwise treat tissue (e.g., a functional assembly configured as a treatment assembly or treatment module).
- a functional assembly can be configured as a diagnostic assembly that records one or more parameters, such as a patient physiologic parameter; a patient anatomical parameter; a patient environment parameter; and/or a system parameter.
- Docket No. CYT-014-PCT A functional assembly can comprise a deployable assembly, such as a robotically controlled assembly.
- a functional assembly can comprise one or more functional elements.
- the term “agent” shall include but not be limited to one or more agents selected from the group consisting of: an agent configured to improve and/or maintain the health of a patient; a drug (e.g., a pharmaceutical drug); a hormone; a protein; a protein derivative; a small molecule; an antibody; an antibody derivative; an excipient; a reagent; a buffer; a vitamin; a nutraceutical; and combinations of these.
- a drug e.g., a pharmaceutical drug
- a hormone e.g., a pharmaceutical drug
- a “treatment target” or “tissue target” comprises one or more volumes of tissue to be diagnosed and/or treated.
- “safety margin tissue” comprises tissue whose treatment (e.g., receiving of a microcoring treatment) yields no significant adverse effect to the patient.
- Non-target tissue comprises tissue that is not intended to receive treatment (e.g., not intended to receive a microcoring treatment).
- system parameter comprises one or more parameters of the system of the present inventive concepts.
- a system parameter can comprise one or more “tissue treatment parameters” (also referred to as “tissue treatment settings”), such as one, two or more tissue treatment parameters selected from the group consisting of: a “microcoring parameter” (also referred to as a “coring parameter” herein), such as a reciprocating motion parameter as described herein; a target level of a patient parameter such as a patient diagnostic parameter and/or a patient environment parameter as described herein; a tissue-type parameter; a tissue target area parameter; a tissue anatomical location area parameter; and combinations of these.
- tissue treatment parameters also referred to as “tissue treatment settings”
- tissue treatment parameters selected from the group consisting of: a “microcoring parameter” (also referred to as a “coring parameter” herein), such as a reciprocating motion parameter as described herein; a target level of a patient parameter such as a patient diagnostic parameter and/or a patient environment parameter as described herein; a tissue-type parameter; a tissue target area parameter; a tissue anatomic
- Microcoring parameters include but are not limited to: depth of penetration of a coring element; duration and/or speed of penetration of a coring element such as rise time of speed of penetration of a coring element; penetration dwell time (also referred to as “hold time”); duration and/or speed of withdrawal of a coring element; time between penetrations; density of coring (also referred to as “microcoring density”); spacing between coring elements; coring diameter; location of penetration; coring suction force; skin suction force (e.g., vacuum pressure and contact area); vacuum “pinch” time (e.g., time to release skin suction); vacuum regeneration time (e.g., as dictated by tubing and/or filter volume and controlled leaks in the system); frequency of coring; inner diameter surface friction of coring element; and combinations of these.
- a system parameter can comprise a parameter selected from the group consisting of: a tissue treatment parameter; a microcoring parameter; an energy delivery parameter; a pressure level; a temperature level; an energy Docket No. CYT-014-PCT level; a power level; a frequency level; an amplitude level; a battery level; a threshold level for an alarm or other alert condition; and combinations of these.
- a system parameter can include one or more tissue targets identified to be treated (e.g., areas of skin tissue to be treated), such as tissue targets identified for treatment by an operator and/or by an algorithm of the system.
- the term “patient parameter” comprises one or more parameters associated with the patient.
- a patient parameter can comprise a patient physiologic parameter, such as a physiologic parameter selected from the group consisting of: temperature (e.g., tissue temperature); pressure such as blood pressure or other body fluid pressure; pH; a blood gas parameter; blood glucose level; hormone level; heart rate; respiration rate; and combinations of these.
- a patient parameter can comprise a patient environment parameter, such as an environment parameter selected from the group consisting of: patient geographic location; temperature; pressure; humidity level; light level; time of day; and combinations of these.
- image data comprises data created by one or more imaging devices. Image data can include data related to target tissue, safety margin tissue, and non-target tissue.
- Image data can also include data related to any implants or other non- tissue objects that are proximate tissue being imaged.
- Image data can be processed by one or more algorithms of the present inventive concepts, such as to determine one or more locations to treat (e.g., target tissue identified to be ablated or otherwise receive microcoring or other treatment), and/or to determine one or more locations to which treatment (e.g., microcoring) is to be avoided (e.g., non-target tissue).
- Image data can comprise data produced by a single imaging component, or from multiple imaging components.
- the term “transmitting a signal” and its derivatives shall refer to the transmission of power and/or data between two or more components, in any direction, such as via wired or wireless connections.
- patient use data shall refer to data related to use of the tissue treatment systems of the present inventive concepts on a patient (e.g., use of the system in a diagnostic and/or therapeutic procedure performed on a patient).
- the data can include but is not limited to: operating parameters such as tissue treatment parameters; target tissue parameters such as location of target tissue and/or amount of target tissue to be treated; patient parameters such as patient physiologic parameters and/or patient location or other patient environment parameters; operator parameters; site parameters; and combinations of these.
- Patient use data can include data from multiple patients, such as data collected from Docket No. CYT-014-PCT multiple patients that interface with (e.g., receive a treatment from) one or more systems of the present inventive concepts.
- an algorithm of the present inventive concepts uses patient use data from one or more patients to determine a system parameter to be used in performing a skin treatment procedure on a patient.
- critical structure shall refer to a particular structure to which a treatment (e.g., a particular microcoring procedure) should be avoided.
- microcoring treatment plan or simply a “treatment plan” shall refer to a set of treatment variables (e.g., reciprocating motion parameters and/or other microcoring parameters) and/or a set of treatment locations (e.g., microcoring treatment locations) that can be created to define a future microcoring treatment to be performed.
- a system of the present inventive concepts produces one, two, or more microcoring treatment plans based on various data (e.g., patient data) recorded by the system, and/or data input into the system (e.g., by an operator of the system).
- the systems, devices, and methods of the present inventive concepts can be configured for treating skin (e.g., eliminating tissue volume, tightening skin, lifting skin, reducing skin laxity, and/or otherwise providing a cosmetic effect), such as by selectively excising a plurality of microcores of patient tissue.
- the tissue is treated without thermal energy being imparted to surrounding (e.g., non-excised) tissue.
- tissue skin
- microcoring refers to technologies that utilize one or more (in some embodiments, a plurality, e.g., an array) hollow needles, or other non-thermal treatment elements (e.g., blades, tubes, and/or drills) that remove and/or otherwise treat tissue of a patient.
- These treatment elements can be of sufficiently small dimension (e.g., comprise a sufficiently small diameter) to minimize the extent of bleeding and/or clotting within holes or slits, and/or to minimize scar formation, when used to excise (e.g., and optionally sequester) tissue from a site.
- excising a tissue means forming a tissue portion (e.g., a “microcore”), such as by inserting a hollow needle into the site so that the tissue portion is formed inside the hollow needle and severed from surrounding tissue, whereby a microcore that is separated (e.g., physically separated) from other tissue is generated.
- microcoring elements, assemblies, and/or other components as described herein may include a component configured to perform sequestration of the excised tissue.
- sequestering when used in reference to tissue, means excising a microcore and then removing the excised microcore from the excision site.
- sequestered tissue may be permanently disposed.
- sequestered tissue may be used for diagnostic purpose, such as when used for biopsy and/or histology analyses, such as those known in the art.
- technologies provided herein maximize removal and/or minimize risk of (partial or complete) re-insertion of extracted tissue.
- microcoring technologies using hollow needles specifically described herein serve for exemplary and/or illustrative purposes, and that other techniques and devices can be used to create microcores.
- Microcoring technologies described herein may include a number of advantageous features. For example, provided technologies may enable visualization of results in real time during the course of the treatment, such as through feedback (e.g., patient and/or operator feedback) and subsequent treatment adjustment in real time.
- the systems and devices of the present inventive concepts that are used for microcoring can include micro-sized features that may be beneficial for controlling extent of skin treatment and/or minimize adverse effects of the skin treatment.
- technologies described herein may require less skill than that of a surgeon.
- a patient may be treated by a non- physician professional and/or in an outpatient setting, rather than in an inpatient, surgical setting.
- a patient may be treated at a spa, at a cosmetic salon, or at home. That is, the technologies of the present inventive concepts are amenable to and/or permit consistent and/or reproducible administration of skin treatment procedures in a variety of treatment settings, and with a broad range of technicians and/or other operators (“operators” herein) performing the procedures.
- the technologies described herein may have generally a lower risk profile and/or the technologies can provide more predictable results and/or risk factors than those for more invasive techniques (e.g., plastic surgery) or energy-based techniques (e.g., laser, radiofrequency (RF), or ultrasound), which may or may not be invasive. Docket No. CYT-014-PCT [155]
- non-thermal fractional excision technologies described herein allow skin tightening, skin lifting, and/or reduction of skin laxity without (or with significant reduction of) one or more common side effects of thermal treatment methods (e.g., thermal ablation and/or other treatment methods that increase and/or otherwise modify the temperature of tissue in order to provide a treatment to that tissue).
- Thermal ablation techniques prevent and/or inhibit skin tightening by allowing coagulation of tissue and formation of rigid tissue cores that cannot be compressed.
- Thermal ablation techniques create a three-dimensional heat-affected zone (HAZ) surrounding an immediate treatment site.
- fractional ablative lasers may be used on or near heat-sensitive sites (e.g., eyes, nerves), for example when the laser does not penetrate more than 1 mm into the skin (resulting in a comparatively small HAZ)
- other thermal ablation techniques e.g., ultrasound- based techniques and radiofrequency-based techniques
- the HAZ may extend to heat sensitive tissues potentially causing undesired damage (e.g., permanent undesired damage).
- a “heat-sensitive site” is a site where exposure to radiation and/or elevated temperature is associated with a relatively high risk of unacceptable cosmetic and/or physiologic outcomes.
- technologies of the present inventive concepts described herein have generally a lower risk profile than, for example, thermal methods, at least in part due to a zone of tissue injury that is smaller than the zone of injury (e.g., the HAZ) of thermal methods.
- advantages of certain technologies described herein include a therapeutic benefit selected from the group consisting of: a particularly low (e.g., lesser than that observed with other techniques such as invasive techniques and/or thermal techniques) degree of erythema; faster resolution of erythema; lower percent incidence, severity, and/or term of skin discoloration (hyperpigmentation or hypopigmentation); low swelling and/or inflammation (e.g., as compared with that observed with laser treatment and/or with ultrasound-based treatment); and combinations of these.
- a particularly low e.g., lesser than that observed with other techniques such as invasive techniques and/or thermal techniques
- degree of erythema e.g., faster resolution of erythema
- lower percent incidence, severity, and/or term of skin discoloration hyperpigmentation or hypopigmentation
- low swelling and/or inflammation e.g., as compared with that observed with laser treatment and/or with ultrasound-based treatment
- the technologies provided herein can allow for rapid closing of holes and/or slits after excising tissue (e.g., within a few seconds after treating skin, such as within ten seconds), thereby minimizing extent of bleeding and/or clotting within holes and/or slits, and/or minimizing the extent of scar formation.
- the technologies provided herein may be useful for maximizing treatment effect while minimizing treatment time, such as by using rapid-fire Docket No. CYT-014-PCT reciprocating needles or needle arrays, and/or by using large needle arrays that allow for simultaneous excision of tens, hundreds, or even thousands of microcores.
- the technologies described herein may be useful for maximizing tightening effect while minimizing healing time and/or minimizing the time in which a cosmetic effect occurs, such as by optimizing tightening (e.g., by controlling the extent of skin pleating, such as by increasing the extent of skin pleating for some applications or skin regions and/or by decreasing the extent of skin pleating for other applications or skin regions, as described herein).
- the technologies described herein may provide efficient clearance of sequestered and/or partially ablated tissue, and/or provide efficient clearance of debris from ablated tissue portions, thus reducing time for healing and/or improving the skin tightening treatment (e.g., relative to laser-based and/or other thermal technologies).
- the technologies described herein may be configured to allow for efficient and effective positioning of skin prior to, during, and/or after tissue excision (e.g., excision including tissue sequestration). Positioning the skin can be critical to control skin-tightening direction, and it can ensure treatment occurs in the desired location and desired dimensions (e.g., thickness, width in a preferred direction, such as along or orthogonal to Langer lines).
- tissue excision e.g., excision including tissue sequestration
- Positioning the skin can be critical to control skin-tightening direction, and it can ensure treatment occurs in the desired location and desired dimensions (e.g., thickness, width in a preferred direction, such as along or orthogonal to Langer lines).
- desired dimensions e.g., thickness, width in a preferred direction, such as along or orthogonal to Langer lines.
- the systems, devices, and methods of the present inventive concepts can include microcoring technologies that are configured to achieve desirable (e.g., reduced) procedure times and/or can significantly improve one or more aspects
- Described herein are technologies, methods, and/or devices for treating skin, such as by selectively microcoring skin tissue.
- hollow needles or other hollow filaments (“needles” herein), as well as related systems (e.g., including kits), devices, and methods, capable of microcoring tissue portions by capturing and retaining the tissue portions inside a lumen of one or more hollow needles after insertion into and withdrawal from the skin.
- Microcored tissue portions can be removed from a lumen of a hollow needle and discarded. The process can be repeated to generate multiple microcored (also referred to as “cored” herein) skin tissue portions, in particular over a desired area of skin and located at chosen sites of the body of a patient.
- technologies described herein include a treatment device, such as a handheld treatment device.
- An example treatment device may include a treatment module (e.g., a needle hub) comprising at least one hollow needle configured to remove a portion of the skin tissue (e.g., a microcore) when the hollow needle is inserted into and withdrawn from the skin tissue.
- a treatment device may include an activation assembly (e.g., a translation and/or actuation assembly) connected to the treatment module, such as to translate (e.g., along one, two, and/or three axes) and/or actuate the treatment module in one or more directions relative to a surface of the skin tissue.
- a treatment device may include a spacer to stabilize and/or maintain a constant position of the treatment device relative to the surface of the patient’s skin tissue.
- a treatment device may include a hand piece including a hand piece shell, such as a housing that at least partially encases the activation assembly.
- a hand piece and/or hand piece shell may include or may be connected to a spacer, such as a connection at a distal end of a treatment device (e.g., an end of a treatment device for contacting skin).
- a spacer such as a connection at a distal end of a treatment device (e.g., an end of a treatment device for contacting skin).
- a tissue treatment procedure performed using system 10 can include the performance of one or more procedures, such as one or more diagnostic procedures and/or one or more treatment procedures (e.g., a tissue treatment procedure) performed on a mammalian subject.
- system 10 is used by a clinician or other operator (“clinician” or “operator” herein) to perform one, two or more procedures, that are performed within a single day or over multiple days.
- System 10 can be configured to diagnose and/or treat one or more conditions of the subject to be treated (e.g., skin conditions, cosmetic issues, and/or other conditions of the subject to be treated).
- System 10 can be configured to treat and/or diagnose one or more portions (e.g., volumes) of patient tissue, “target tissue” herein.
- system 10 comprises one, two or more devices that are configured to treat target tissue, such as to improve cosmesis of the patient (e.g., via microcoring as described herein).
- system 10 is of similar construction and arrangement, and can include similar components, to the systems described Docket No. CYT-014-PCT in applicant’s co-pending United States Patent Application Serial Number 17/291,235, titled “Systems and Methods for Skin Treatment", May 4, 2021.
- System 10 can include one or more devices that are configured to gather various forms of patient information, patient data PD or data PD herein.
- system 10 can include one or more devices or other components configured to collect patient data PD comprising patient diagnostic data, diagnostic data DD or data DD herein.
- Diagnostic data DD can comprise data related to a physiologic parameter of the patient, data related to the anatomy of the patient, data related to the environment of the patient (e.g., the current environment of the patient), and/or other patient-related data.
- system 10 can include one or more devices or other components configured to collect patient use data (e.g., as defined herein).
- system 10 can include one or more devices or other components configured to collect patient data PD comprising patient image data, image data ID, which can comprise image data of tissue and/or one or more objects proximate tissue.
- Patient data PD can include data that is used in determining (e.g., by system 10 and/or an operator of system 10) a diagnosis and/or prognosis (either or both, “diagnosis” herein) for the patient.
- patient data PD can include patient data that is used in a tissue treatment procedure (e.g., by system 10 and/or an operator of system 10), such as to guide or otherwise affect a microcoring and/or other treatment performed on the patient.
- Image data ID can include image data related to: target tissue; safety margin tissue; non-target tissue; an implanted diagnostic and/or a treatment device; a foreign body (e.g., a splinter, tattoo, and the like); and combinations of these.
- System 10 can be configured to produce image data ID through the delivery of energy, such as X-ray energy, sound energy (e.g., ultrasound energy), and/or light energy that is delivered and whose reflections and/or other transmissions are collected in order to produce image data ID.
- image data ID comprises data related to tissue comprising blood, such as when image data ID comprises blood flow data (e.g., as obtained using Doppler ultrasound).
- tissue diagnostic procedure includes but are not limited to: collection of diagnostic data DD; collection of image data ID (e.g., when system 10 records reflections and/or other transmissions of delivered X-ray, ultrasound, light, and/or other energy, and converts these recordings into image data ID); delivery of energy to tissue to characterize the tissue (e.g., when system 10 records one or more effects on the tissue due to the energy delivery, such as using spectroscopy); and/or recording of one or more tissue properties using one or more sensors and/or imaging devices of system 10.
- a tissue diagnostic procedure can also include a Docket No.
- tissue treatment procedure in which various patient parameters are collected, such as patient environment parameters and/or a patient physiologic parameter, for example as described herein.
- tissue treatment procedure include but are not limited to: microcoring of tissue; removal of tissue; ablation of tissue; causing the necrosis of tissue; reducing the volume of tissue (e.g., debulking tissue); stimulating tissue; improving the strength of tissue (e.g., muscle tissue); manipulating and/or otherwise applying a force to tissue; stiffening tissue; and/or otherwise providing a cosmetic enhancement and/or other therapeutic effect to tissue.
- System 10 includes treatment device 100 which can comprise one, two or more treatment devices that are configured to perform a treatment procedure on a patient (e.g., a microcoring or other tissue treatment procedure).
- Treatment device 100 can be configured to treat target tissue (e.g., perform a microcoring of target tissue). Alternatively or additionally, treatment device 100 can be configured to diagnose target tissue (e.g., gather diagnostic data DD and/or image data ID).
- Treatment device 100 can include one or more modules, treatment module 150 shown, each of which can be configured to perform a patient treatment (e.g., a microcoring treatment).
- Treatment module 150 can comprise one, two, three or more filaments for coring tissue, coring elements 155 shown.
- Treatment device 100 can include actuation assembly 120 shown, which can comprise one, two or more assemblies configured to interface with treatment module 150, such as is described herein.
- Treatment device 100 can include spacer assembly 180 shown, which can comprise one or more assemblies that are constructed and arranged to be positioned between a corresponding one or more treatment modules 150 and tissue.
- System 10 can include console 500 shown, which can comprise one, two or more discrete devices, where each of which can operably attach to one, two or more treatment devices 100, simultaneously and/or sequentially.
- Console 500 can include a connector, connector 505 as shown, which can be configured to operably attach (e.g., electrically, mechanically, fluidly, optically, sonically, and/or otherwise operably attach) to treatment device 100, such as via cable 103 of treatment device 100.
- Console 500 can be configured to allow an operator to control one or more treatment devices, such as via user interface 510 shown.
- Console 500 can comprise various assemblies and other components, as described herein, which singly or in combination are configured to provide to treatment device 100 one or more of: energy; mechanical, hydraulic, and/or pneumatic linkages; an agent (e.g., agent 60 described hereinbelow); and/or control signals.
- Console 500 can be configured to receive data from treatment device 100.
- console 500 is Docket No. CYT-014-PCT integrated into a treatment device 100 (e.g., the treatment device 100 is a relatively stand- alone device).
- Console 500, and/or another component of system 10 can comprise one or more algorithms, algorithm 25 shown.
- treatment device 100 and/or another component of system 10 comprises all or a portion of algorithm 25.
- Algorithm 25 can analyze various information related to: microcoring procedures performed using system 10 (e.g., using treatment device 100); information uploaded into system 10 via patient device 300, clinician device 400, and/or vendor device 700 (each as described herein); information obtained from healthcare records (e.g., electronic healthcare records) of a hospital, clinician’s office, and/or other clinical setting; information obtained from network 80 (e.g., the Internet); and/or combinations of these.
- microcoring procedures performed using system 10 e.g., using treatment device 100
- information uploaded into system 10 via patient device 300, clinician device 400, and/or vendor device 700 each as described herein
- information obtained from healthcare records e.g., electronic healthcare records of a hospital, clinician’s office, and/or other clinical setting
- information obtained from network 80 e.g., the Internet
- algorithm 25 is configured to determine one or more microcoring parameters for a particular patient, and the information analyzed by algorithm 25 to determine these parameters comprises data such as: patient data PD described herein; clinician data CD described herein; vendor data VD described herein, and/or other data related to the patient, one or more clinicians, one or more vendors, and/or system 10.
- algorithm 25 is configured to be adjusted, such as by a clinician, such as to adjust an algorithm 25 configured to determine one or more microcoring parameters and/or one or more parameters associated with post-microcoring care.
- System 10 can include imaging device 50 shown, which can comprise one, two or more imaging devices. Imaging device 50 can be configured to collect image data ID.
- imaging device 50 comprises one, two or more imaging devices selected from the group consisting of: a fluoroscope or other X-ray imaging device; an ultrasound imager; a CT scanner; an MRI; an OCT imaging device; a camera such as a visual light camera and/or an infrared camera; and combinations of these.
- Imaging device 50 can comprise a device configured to characterize and/or otherwise collect data related to one or more properties of tissue, such as a device (e.g., an ultrasound-based device) configured to measure elasticity of tissue and/or other tissue property (e.g., with or without collecting an image of the tissue).
- image data ID provided by imaging device 50 can be used to determine a target area to treat with system 10, and/or a non-target area to which treatment should be avoided.
- algorithm 25 can be configured to analyze image data ID and provide feedback (e.g., suggestions and/or requirements) for particular tissue areas to be classified as target areas and/or non-target areas.
- algorithm 25 is configured to identify one or more implants or other objects present under the patient’s skin, to which treatment should be adjusted (e.g., avoided), such as an under-the- Docket No. CYT-014-PCT skin object comprising: an implant (e.g., implant 70 described hereinbelow) such as a cosmetic implant; a splinter; and/or tattoo ink.
- algorithm 25 can be configured to identify a periphery of the under-the-skin object, such as to define a non-target zone including at least the area within the periphery (e.g., and also including a safety margin outside of the periphery).
- System 10 can include agent 60 shown, which can comprise one or more pharmaceuticals and/or other agents that can be delivered to the patient. Agent 60 can comprise an agent that is applied topically and/or an agent that is delivered systemically (e.g., orally).
- Agent 60 can comprise one, two, or more agents selected from the group consisting of: hyaluronic acid; a moisturizer; an analgesic; a peptide; an exosome; platelet rich plasma (PRP); arnica montana extract; a vasoconstrictor; methotrexate; minoxidil; stem cells; botulinum toxin; a corticosteroid; and combinations of these.
- agents selected from the group consisting of: hyaluronic acid; a moisturizer; an analgesic; a peptide; an exosome; platelet rich plasma (PRP); arnica montana extract; a vasoconstrictor; methotrexate; minoxidil; stem cells; botulinum toxin; a corticosteroid; and combinations of these.
- Agent 60 can comprise an agent that is applied topically, and or inserted into the patient, such as when injected or otherwise inserted into the dermis of the patient, such as when deposited in or otherwise proximate one or more target areas to be treated (e.g., pre-microcoring), during treatment (e.g., when deposited via coring elements 155 or otherwise), and/or after treatment (e.g., after microcoring).
- target areas to be treated e.g., pre-microcoring
- during treatment e.g., when deposited via coring elements 155 or otherwise
- after treatment e.g., after microcoring
- a functional element 99 comprises a delivery device configured to deliver agent 60, such as a syringe, needle, transdermal patch, microfluidic pump, and/or other delivery device configured to deliver agent 60 to the surface of the skin and/or to an internal location (e.g., into the dermis).
- System 10 can include implant 70 shown, which can comprise one or more implants which can be implanted in the patient such as to improve cosmesis of the patient, and/or to treat a disease and/or disorder of the patient.
- a treatment performed by system 10 includes the implantation of one or more implants 70, such as to further improve cosmesis of the patient.
- a treatment performed by system 10 is adjusted due to the presence of an existing implant (e.g., implant 70), and/or due to a future implantation of an implant (e.g., implant 70).
- System 10 can include tissue collection assembly 600 shown (also referred to as “TCA 600” herein), which can comprise one or more assemblies configured to collect tissue which has been removed from the patient by treatment module 150.
- TCA 600 can comprise one or more containers for storing collected tissue.
- TCA 600 can comprise a vacuum pump and/or other low-pressure source, LPS 650 shown, such as to create a pressure differential which causes tissue extracted by treatment device 100 to be drawn into TCA 600. Docket No.
- System 10 can include one or more functional elements, such as functional element 199 of treatment device 100, and/or functional element 599 of console 500, and/or functional element 99, each as shown.
- Functional elements 99, 199, and/or 599 can comprise one or more sensors and/or transducers, and/or an assembly that includes one or more sensors and/or transducers.
- Functional element 99, 199, and/or 599 can comprise a component (e.g., a sensor, or an assembly including a sensor) that is configured to collect patient data PD, such as diagnostic data DD and/or image data ID as described herein.
- functional element 199 comprises at least one sensor, sensor 199a shown.
- functional element 599 comprises at least one sensor, sensor 599a shown.
- Functional elements 99, 199, and/or 599 can comprise one, two or more sensors configured to collect diagnostic data DD of a patient, and/or image data ID of a patient.
- Functional elements 99, 199, and/or 599 can comprise a sensor (e.g., sensor 199a and/or 599a) that is configured to produce a signal related to tissue being captured in a coring element 155.
- tissue being captured in a coring element 155 results in system 10 automatically adjusting one or more microcoring parameters (e.g., depth of penetration of element 155, velocity of element 155 advancement and/or retraction, and/or acceleration of element 155 advancement or retraction).
- detection of tissue being captured in a coring element 155 is used to determine (e.g., automatically determine) a minimum depth of penetration of element 155.
- Functional elements 99, 199, and/or 599 can comprise a wireless element, such as a wireless transmitter that can send and/or receive power and/or data wirelessly.
- a functional element 99, 199, and/or 599 comprises a sensor and/or a transducer that receives power wirelessly, and/or transmits signals (e.g., recorded sensor signals) wirelessly.
- Functional elements 99, 199, and/or 599 can comprise one or more sensors selected from the group consisting of: accelerometer; gravity-based sensor; strain gauge; acoustic sensor (e.g., a microphone or other acoustic sensor); electromagnetic sensor (e.g., a hall effect sensor); pressure sensor; vibration sensor; temperature sensor; vacuum sensor; GPS sensor; pH sensor; optical sensor; and combinations of these.
- Functional elements 99, 199, and/or 599 can comprise a patient “physiologic sensor” comprising one, two or more sensors configured to measure a patient physiologic parameter such as: body temperature; heart rate; blood pressure; respiration rate; perspiration rate; blood gas level; blood glucose level; brain and/or other neural activity such as measured Docket No. CYT-014-PCT by electroencephalogram (EEG), local field potential (LFP), and/or neuronal firing (e.g., single neuron firing activity); eye motion; EKG; and combinations of these.
- a patient physiologic sensor comprising one, two or more sensors configured to measure a patient physiologic parameter such as: body temperature; heart rate; blood pressure; respiration rate; perspiration rate; blood gas level; blood glucose level; brain and/or other neural activity such as measured Docket No. CYT-014-PCT by electroencephalogram (EEG), local field potential (LFP), and/or neuronal firing (e.g., single neuron firing activity); eye motion
- Functional elements 99, 199, and/or 599 can comprise a patient “environment sensor” comprising one, two or more sensors configured to measure a patient “environment parameter” such as: room temperature; room humidity; room pressure; room light level; room ambient noise level; room barometric pressure; and combinations of these.
- a patient “environment sensor” comprising one, two or more sensors configured to measure a patient “environment parameter” such as: room temperature; room humidity; room pressure; room light level; room ambient noise level; room barometric pressure; and combinations of these.
- functional elements 99, 199, and/or 599 comprise one or more sensors configured to measure a system 10 parameter, such as a system parameter selected from the group consisting of: temperature of at least a portion of a system 10 component; pressure and/or strain of a system 10 component; speed and/or acceleration of a system 10 component (e.g., speed and/or acceleration of a coring element 155 and/or other portion of treatment device 100); position and/or geometry of a system 10 component (e.g., position and/or geometry of a coring element 155 and/or other portion of treatment device 100); energy level; power level; and combinations of these.
- a system 10 parameter such as a system parameter selected from the group consisting of: temperature of at least a portion of a system 10 component; pressure and/or strain of a system 10 component; speed and/or acceleration of a system 10 component (e.g., speed and/or acceleration of a coring element 155 and/or other portion of treatment device 100); position and/or geometry of a system 10
- functional element 199 comprises one or more transducers configured to provide tactile feedback to an operator, such as tactile feedback configured to cause the operator to better hold and/or better position treatment device 100 (e.g., during microcoring).
- functional element 199 can further comprise one or more accelerometers, and/or one or more other sensors configured to track movement and/or position of treatment device 100 (e.g., one or more sensors configured to provide one or more signals used by system 10 to track movement and/or position of treatment device 100).
- system 10 is configured to operate in a closed loop mode, in which one or more parameters of treatment device 100 are adjusted based on one or more recorded parameters, such as system parameters, patient physiologic parameters, and/or patient environment parameters, each as described herein.
- algorithm 25 can analyze (e.g., continuously and/or intermittently analyze) one or more signals provided by a functional element 99, 199, and/or 599, and adjust the treatment performed by system 10 based on the analysis.
- functional elements 99, 199, and/or 599 comprise one or more transducers selected from the group consisting of: cooling element such as a Peltier element; heating element such as a Peltier element or a heat pump; vibrational transducer; light-producing element; a magnetic field-generating element; vacuum-generating element; and combinations of these. Docket No. CYT-014-PCT [188] In some embodiments, functional elements 99, 199, and/or 599 comprise an assembly or other component configured to provide a vacuum to another component of system 10.
- functional elements 99, 199, and/or 599 can comprise a tissue- engaging port configured to receive a vacuum (e.g., from console 500) and to stabilize tissue, capture tissue (e.g., draw tissue toward the port) and/or otherwise engage tissue, when the vacuum is applied to the port.
- a vacuum e.g., from console 500
- capture tissue e.g., draw tissue toward the port
- functional elements 99, 199, and/or 599 can comprise a source of vacuum, such as vacuum that can be applied to such a tissue-engaging port.
- functional elements 99, 199, and/or 599 comprise an adhesive, and/or an adhesive dispensing component, such as when an adhesive is used to temporarily (e.g., less than 1 day) and/or chronically (e.g., at least 1 week, 1 month, or 3 months) attach a component of system 10 to tissue of the patient, and/or to another component of system 10.
- functional elements 99, 199, and/or 599 comprise a cooling fluid or cooling component (e.g., a thermoelectric cooling element) and/or an assembly configured to provide cooling (e.g., provide cooling to a system 10 component).
- system 10 is configured to provide cooling to tissue and/or to a system 10 component during delivery of a tissue treatment and/or diagnosis, such as to avoid damage to non-target tissue and/or to avoid degradation of a system 10 component.
- system 10 can comprise a functional element comprising an assembly configured to provide a cooling fluid (e.g., in a recirculating arrangement) to another system 10 component.
- functional elements 99, 199, and/or 599 comprise an assembly or other component configured to apply a force to tissue (e.g., a grasping component configured to place tissue in tension, and/or a pushing element configured to provide a compressive force to tissue), such as to apply a force (e.g., a tensioning and/or compressing force) to tissue (e.g., target tissue) while a microcoring procedure is being performed on target tissue by another component of system 10.
- a force e.g., a tensioning and/or compressing force
- tissue e.g., target tissue
- Functional elements 99, 199, and/or 599 can comprise an assembly configured to deliver agent 60 to the patient, as described herein.
- agent 60 is delivered to the patient via one or more coring elements 155, where functional element 99, 199, and/or 599 comprises a pump or other fluid propulsion assembly that propels agent 60 through one or more conduits (e.g., fluid delivery tubes) such that agent 60 can be delivered into the patient (e.g., into the dermis of the patient) by one or more (e.g., all) coring elements Docket No. CYT-014-PCT 155 during a microcoring or other procedure performed via injection of elements 155 into the patient.
- Functional element 99 can comprise a cell phone, laptop, tablet, camera, and/or other operator-maintained device.
- Functional element 99 can comprise a patient diagnostic device, such as a device configured to gather patient data PD (e.g., diagnostic data DD and/or image data ID).
- Treatment device 100 comprises various components such as conduits 101, nozzles 102, cable 103, and housing 110. These components can be of similar construction and arrangement to the similar components described in applicant’s co-pending United States Patent Application Serial Number 17/291,235, titled “Systems and Methods for Skin Treatment", May 4, 2021.
- Coring elements 155 can comprise one, two or more hollow filaments, such as the coring elements 155 described herein in reference to Figs.3A-D.
- Each coring element 155 can comprise an elongate shaft (e.g., a hollow shaft), shaft 1551 shown, which can include a distal end.
- Each coring element 155 can comprise one or more projections, prong 1552 shown, that extend from the distal end of shaft 1551.
- Spacer assembly 180 can comprise a housing and other components that are configured to properly position treatment module 150 relative to the patient’s skin being treated.
- Spacer assembly 180 can include one or more sensors, sensor 181 shown, which can be configured to detect proper engagement of spacer assembly 180 with the patient (e.g., proper pressure level detected).
- Actuation assembly 120 can be configured to interface with treatment module 150 by performing a function selected from the group consisting of: control the motion of a treatment module 150 (e.g., translate treatment module 150 along one, two, or three axes); activate one or more components of treatment module 150 (e.g., advance and/or retract one or more coring elements 155 into and/or from tissue); rotate one or more components of treatment module 150 (e.g., rotate one or more coring elements 155 prior to, during, and/or after their insertion into tissue); vibrate one or more components of treatment module 150; and combinations of these.
- Actuation assembly 120 comprises actuator 121 shown.
- Console 500 can comprise user interface 510 as shown, which can comprise one or more user input and/or user output components, such as one, two or more components selected from the group consisting of: display; touch screen display; button; switch; foot switch; lever; membrane keypad; mouse, joystick; microphone; speaker; vibrational and/or other haptic transducer; light such as a light emitting diode; and combinations of these.
- Console 500 can comprise controller 520 as shown, which can include: one or more central processing units (CPUs), microprocessors and/or other microcontrollers, processor 521 shown; memory 522 shown (e.g., volatile or non-volatile memory); instructions 523 shown; signal processing and other electronic circuitry; oscillator circuitry such as voltage-controlled oscillator (VCO) circuitry; analog to digital circuitry; digital to analog circuitry; and/or other componentry configured to control or otherwise interface with one or more components of system 10.
- Controller 520 can comprise a power supply and/or energy storage component (e.g., a battery, a capacitor, and/or a power supply converted to receive “wall power” and convert it to an AC or DC voltage for use by system 10).
- a power supply and/or energy storage component e.g., a battery, a capacitor, and/or a power supply converted to receive “wall power” and convert it to an AC or DC voltage for use by system 10).
- Console 500 can further comprise drive module 550, and vacuum assembly 560, each as shown.
- Console 500 and its various components can be of similar construction and arrangement to those described in applicant’s co-pending United States Patent Application Serial Number 17/291,235, titled “Systems and Methods for Skin Treatment", May 4, 2021.
- System 10 can include one or more accessory components, accessories 90 shown.
- Accessories 90 can include one or more accessory components, such as those described in reference to Fig.4 herein.
- microcoring treatment plan can refer to a set of treatment variables (e.g., reciprocating motion parameters and/or other microcoring parameters) and/or a set of treatment locations (e.g., microcoring treatment locations) that can be created to define a future microcoring treatment to be performed.
- a “microcoring treatment plan” or a “treatment plan” can comprise a set of parameters that are used in treating target tissue of the patient using system 10.
- a treatment plan can include a set of treatment settings, such as one, two or more microcoring parameters (e.g., reciprocating motion parameters, target tissue parameters, patient parameters, and/or other microcoring parameters).
- a treatment plan can include a set of different skin and/or other tissue treatment, and/or other procedures (e.g., one, two or more microcoring procedures and/or other treatment procedures).
- a treatment plan can include a desired and/or Docket No. CYT-014-PCT recommended order for performing a set of multiple tissue treatments or other procedures (e.g., where the treatment plan provides multiple procedures to be performed in a particular order, where in some instances sufficient efficacy is achieved when a subset of the procedures is performed).
- system 10 is configured to automatically and/or semi-automatically (“automatically” herein) generate a treatment plan (e.g., one or more treatment plans made available to an operator of system 10).
- System 10 can generate a treatment plan using an algorithm, such as algorithm 25 described herein.
- a treatment plan can be developed by algorithm 25 using at least image data ID, such as by using image data ID comprising: ultrasound-based image data (e.g., Doppler data and/or other image data produced using ultrasound); CT-based image data; MRI-based image data; and/or X-ray- based image data (e.g., fluoroscopic data and/or other image data produced using X-ray).
- image data ID comprising: ultrasound-based image data (e.g., Doppler data and/or other image data produced using ultrasound); CT-based image data; MRI-based image data; and/or X-ray- based image data (e.g., fluoroscopic data and/or other image data produced using X-ray).
- algorithm 25 can develop a proposed treatment plan based on parameters selected from the group consisting of: patient age; patient race; patient gender; patient skin type; patient skin condition; volume of target tissue to be treated; cellulite and/or fat content of target tissue; geometry of target tissue; tissue type, geometry and/or other characteristic of non-target tissue proximate the target tissue; and combinations of these.
- a treatment plan includes a methodology to ensure treatment of target tissue, while avoiding damage to neighboring non-target tissue.
- system 10 e.g., via algorithm 25
- is configured to produce a prediction of outcome e.g., an estimation of likelihood of efficacy and/or an assessment of any risks associated with one or more treatment plans.
- system 10 can comprise one or more algorithms, algorithm 25 shown.
- Algorithm 25 can comprise one or more algorithms that are performed by a processor (e.g., a processor of a system 10 component, such as processor 521 of controller 520).
- the processor can perform algorithm 25 using instructions (e.g., instructions 523 of controller 520 and/or instructions of another component of system 10), such as instructions that are stored in memory of that component (e.g., instructions 523 that are stored in memory 522 of controller 520).
- All or a portion of algorithm 25 can be integrated into one, two or more of various components of system 10, such as a server (e.g., server 20 described herein), console 500, treatment device 100, a patient device (e.g., patient device 300 described herein), a clinician device (e.g., clinician device 400 described herein), a vendor device (e.g., vendor device 700 described herein), imaging device 50, TCA 600, and/or functional element 99.
- Algorithm 25 can comprise one or more machine learning, neural network, and/or other artificial intelligence algorithms (“AI algorithm” herein). Docket No.
- Algorithm 25 can be configured to determine and/or modify one or more microcoring parameters, such as to effectively treat target tissue (e.g., improve cosmesis of the patient) and/or avoid damage to non-target tissue.
- algorithm 25 can be configured to determine a volume of target tissue to be treated (e.g., treated with a microcoring procedure), such as to effectively enhance cosmesis of the patient and/or otherwise provide a therapeutic benefit to the patient, while avoiding or at least minimizing damage to non-target tissue.
- algorithm 25 can be further configured to determine and/or modify one or more microcoring parameters (e.g., at least based on the determined volume), such as to effectively treat the target tissue volume determined, while avoiding damage to non-target tissue, as described hereinabove.
- Algorithm 25 e.g., an AI algorithm
- Algorithm 25 can be configured to perform a “microcoring analysis” comprising using an analysis of one or more types of information by algorithm 25 to assess the level of microcoring (e.g., the current level of microcoring) of target tissue. The results of this analysis can be used by system 10 to perform microcoring in a closed loop mode.
- Microcoring data produced in the microcoring analysis can be stored as image data ID (e.g., and correlated with one or more tissue locations).
- system 10 e.g., treatment device 100 and/or imaging device 50
- delivers and/or receives energy e.g., light energy and/or ultrasound energy or other imaging-capable energy
- algorithm 25 performs a microcoring analysis based on the delivered and/or received energy.
- Algorithm 25 e.g., an AI algorithm
- algorithm 25 is configured to perform an analysis on patient data PD (e.g., patient use data from a single patient, or a group of patients upon which system 10 has performed a treatment procedure), such as to modify a future treatment provided by system 10.
- algorithm 25 e.g., an AI algorithm
- algorithm 25 is configured to provide a treatment plan, such as when algorithm 25 performs analysis on patient data PD comprising data collected during treatment of the patient with system 10 in a previous treatment procedure, and/or based on patient data PD collected from use of system 10 on multiple patients (e.g., a large number of patients treated with system 10).
- System 10 can include network 80 as shown, which can comprise one or more computer networks such as the Internet, a local area network, cellular network, and/or other Docket No. CYT-014-PCT data sharing, storage, and/or transmitting platform.
- patient data PD, and/or other data collected during the use of system 10 is transmitted from one location to another location over network 80.
- one or more central data storage areas are used to store the data, such as when an algorithm 25 analyzes the data to provide a treatment plan and/or provide system 10 parameters for a future treatment of one or more patients.
- Treatment device 100 and/or another component of system 10 can be configured to perform a treatment (e.g., a microcoring treatment) in a “closed loop” mode (i.e. a closed loop mode of microcoring and/or other closed loop mode of operation), such as when one or more sensors of system 10 (e.g., a sensor-based functional element 99, 199, and/or 599), provide patient and/or system information that is used to continuously and/or intermittently adjust the treatment being delivered by treatment device 100 (e.g., adjust the microcoring parameters and/or other parameters of the treatment).
- a treatment e.g., a microcoring treatment
- a “closed loop” mode i.e. a closed loop mode of microcoring and/or other closed loop mode of operation
- one or more sensors of system 10 e.g., a sensor-based functional element 99, 199, and/or 599
- provide patient and/or system information that is used to continuously and/or intermittently adjust the treatment being delivered by treatment
- microcoring can be adjusted in a closed loop mode based on a system 10 parameter and/or based on a patient parameter (e.g., a patient physiologic parameter, patient anatomical parameter, and/or a patient environment parameter, each as described herein).
- a patient parameter e.g., a patient physiologic parameter, patient anatomical parameter, and/or a patient environment parameter, each as described herein.
- Microcoring by treatment device 100 can be adjusted based on image data ID described herein, such as to redirect and/or otherwise adjust microcoring (e.g., due to detected patient motion and/or undesired treatment device 100 motion) and/or to change one or more microcoring parameters (e.g., as determined by algorithm 25 using image data ID or other data).
- image data ID is used to determine when a treatment (e.g., a microcoring amount) is sufficient, such as when algorithm 25 analyzes image data ID to confirm sufficient change in tissue characteristics have occurred.
- system 10 can be configured to perform a series of skin and/or other tissue treatment procedures on a patient, such as a patient desiring improved cosmesis of the face or other body location, as described herein.
- system 10 is configured to be used to: perform a first procedure and a second procedure, in which the two procedures are performed at least 24 hours apart.
- the first procedure can include microcoring
- the second procedure can include microcoring, or both can include microcoring.
- the first procedure does not include microcoring, while the second procedure does include microcoring.
- two, three, four, or more microcoring procedures of the present inventive concepts are performed, such as over a period of months and/or years.
- the treatment plan for a subsequent Docket No. CYT-014-PCT procedure using system 10 is based on the data collected and/or results of one or more previous treatment procedures performed using system 10.
- System 10 can be configured to perform a treatment on a patient (e.g., a patient desiring improved cosmesis of the face or other body location) that includes the performance of multiple, sequential treatment plans, such as a sequence of treatment plans that each may use one, two or more components of system 10 (e.g., one, two or more of treatment devices 100) that are used to perform one or more diagnostic procedures, and/or one or more therapeutic procedures.
- Performance of an “initial treatment plan” performed using system 10 can be configured based on current physiologic state (e.g., current undesired state of tissue) of the patient, as well as any previous treatments performed (e.g., using system 10 or otherwise).
- the one or more coring elements 155 (e.g., three coring elements 155) comprise a dimension selected from the group consisting of: an outer diameter of no more than 0.050in, or no more than 0.040in, such as approximately 0.028in; an inner diameter of no more than 0.030in, or no more than 0.025in, such as approximately 0.016in; a core length of at least 0.5mm and/or no more than 5.0mm; a penetration depth of no more than 6.0mm; a cutting depth of no more than 5.0mm; and combinations of these.
- one or more coring elements 155 comprise a double- beveled needle geometry (e.g., as shown in Figs.3A-D), such as to minimize effective insertion depth and/or resist wear during use.
- system 10 is configured to precisely control insertion speed of the one or more coring elements 155 (e.g., simultaneous insertion of all of coring elements 155).
- the dwell time can comprise a time of no more than 60msec, such as no more than 45msec, no more than 30msec, and/or no more than 20msec.
- System 10 can comprise a proportional integral derivative (PID) controller that provides closed loop control of coring element 155 advancement and position that results in accurate core depth, such as while minimizing impact forces on the patient’s skin (e.g., thus improving healing response and core hole precision).
- PID proportional integral derivative
- multiple coring elements 155 are positioned in an array (e.g., a linear arrangement of three or four elements 155) in which the coring elements 155 are separated by a distance of at least 0.2mm, such as at least 0.5mm, at least 1.0mm, at least 2.0mm, and/or approximately 3.33mm. Docket No.
- System 10 can include tissue collection assembly 600 for clearing tissue cores captured by coring elements 155.
- LPS 650 comprises a single source of low pressure (e.g., vacuum) that provides multiple (e.g., two) functions.
- System 10 can be configured to control the flow rate (e.g., the pressure) proximate the coring elements 155, such as to remove tissue cores without impacting low pressure applied to spacer assembly 180 (e.g., spacer assembly 180 using suction to stabilize treatment module 150 relative to the patient’s skin).
- the flow channels into which the tissue cores are extracted can include a funnel portion that increases the flow velocity at locations where the tissue is extracted from the back ends of the coring elements 155.
- Treatment device 100 can comprise spacer assembly 180, which can provide a stabilizing force to treatment device 100 during use, as described herein.
- spacer assembly 180 can utilize a suction force that allows effective treatment of target tissue areas comprising various surface contours.
- System 10 can include an automated pinch valve in line with vacuum conduits provided to spacer assembly 180, such as to provide enhanced stabilization of treatment module 150 with the patient’s skin between patterns of deployment of one or more coring elements 155.
- the pinch valve can be activated to allow easy repositioning of treatment module 150 (e.g., and spacer assembly 180) at the end of a pattern of microcoring, such as to improve ease and speed of a treatment.
- Treatment device 100 can comprise a “treatment window” that is sized to accommodate various ranges of suction force to be applied.
- spacer assembly 180 provides a treatment window of at least 100mm 2 , such as no more than 2,000mm 2 , such as approximately 640mm 2 , such as to provide a nominal holding force of treatment module 150 (e.g., spacer assembly 180) of at least 10.0N, such as at least 18.0N, such as approximately 28.5N with the patient’s skin.
- System 10 can be configured to detect (e.g., and quantify) deceleration of coring elements 155, such as to minimize damage to the coring elements 155 and/or to detect damage to at least one coring element 155.
- System 10 can include various features that enhance positioning accuracy (e.g., during deployment) of coring elements 155, such as positioning accuracy in X and Y directions, and/or positioning accuracy in the Z dimension (e.g., insertion direction).
- Such features include but are not limited to: 1:1 gearing and/or direct drive in actuation assembly 120; sensor detection of position (e.g., hall sensors and/or optical sensors such as optical encoders); linear bearings (e.g., that minimize undesired motion and/or creep from a desired position); and combinations of these. Docket No.
- System 10 can be configured to provide variable patterns for microcoring (e.g., varied microcoring density), such as to achieve a skin removal percentage (also referred to as “areal fraction”) of no more than 20%, and/or no less than 0.5%, such as at least 1%, and/or at most 10% (e.g., between 1% and 10%).
- Actuation assembly 120 can comprise one or more actuators (e.g., solenoids) that are configured to precisely control movement of one or more coring elements 155 such as to achieve variable depth control within 0.8mm, such as within 0.5mm, while accommodating variability in skin thickness, skin toughness, and/or other varying skin parameters.
- actuators e.g., solenoids
- System 10 can comprise a calibration routine such as to store calibration information created during manufacturing of one or more components of system 10, and/or information collected at a site (e.g., prior to, during, and/or after use of system 10).
- Calibration data can be stored in a treatment module 150, actuation assembly 120, and/or other component of treatment device 100.
- System 10 can be configured to improve accuracy of needle deployment (e.g., in the Z direction), based on the calibration data (e.g., to accommodate variability in manufacturing processes).
- Coring elements 155 can comprise a bevel angle of no more than 30 degrees, such as no more than 25 degrees, and/or no more than 20 degrees, such as to improve healing and/or minimize scarring of the patient.
- System 10 can be configured to control the speed and/or frequency (e.g., repetition rate) of the deployment of the coring elements 155 into the patient’s skin, such as to deploy the elements 155 (e.g., three elements 155 in unison) at a rate of at least 1Hz, or 3Hz, or approximately 8Hz. Alternatively or additionally, system 10 can be configured to deploy the elements 155 (e.g., three elements 155 in unison) at a rate of no more than 30Hz, such as no more than 20Hz, such as approximately 8Hz.
- Applicant has conducted various studies using the systems, devices, methods, and other technologies of the present inventive concepts, such as system 10 and its components as described herein.
- System 10 can be configured to remove skin via microcoring, such as without use of thermal energy (e.g., avoiding damage to cells from heating) during the microcoring procedure.
- Energy-based devices such as fractional laser and radiofrequency ablation lead to Docket No. CYT-014-PCT epidermal and dermal cell necrosis from thermal injury that may inhibit rapid wound closure, an adverse effect that can be avoided via use of system 10.
- System 10 avoids coagulation necrosis and can achieve both early wound closure, and enhanced skin tightening, as described herein.
- the coring elements 155 and other components of system 10 provide numerous benefits including limited side effects, and fast (e.g., expedited) patient recovery. By removing tissue, significant skin tightening can be achieved, as demonstrated by data gained in skin and/or other tissue treatment procedures performed on human subjects.
- System 10 can be configured to both tighten skin and reduce skin wrinkles and/or folds of the patient’s skin. Use of system 10 in human patients has achieved skin tightening as well as reduction in skin wrinkles and/or folds, via removal of skin without the use of thermal energy, while also reducing (e.g., preventing or resulting in minimal) scar formation.
- system 10 comprises multiple microcoring subsystems, such as microcoring subsystems 11a, 11b, 11c through 11n as shown. Each microcoring subsystem 11 can be configured as described in reference to Fig.4 and otherwise herein.
- Fig.2 illustrates a coring element 155 being safely introduced into the skin, such as to subsequently be withdrawn to remove a microcore of tissue, such that the remaining tissue heals with no scarring or at most minimal scarring.
- the treatment provided by system 10 also provides near-immediate closure along the relaxed skin tension lines (RSTLs), with no thermal energy.
- RSTLs relaxed skin tension lines
- FIGs.3A-D various views of a coring element are illustrated, consistent with the present inventive concepts. Typical dimensions of a coring element 155 are shown.
- coring element 155 comprises a penetrating portion with an outer diameter of at least 0.0203” and/or an outer diameter of no more than 0.050”.
- coring element 155 comprises a penetrating portion with an inner diameter of at least 0.0103” and/or an inner diameter of no more than 0.0207”.
- system 10 of Fig.4 includes treatment device 100, console 500, tissue collection assembly 600, and other components as shown, each of which can be of similar construction and arrangement to the similar components described in reference to system 10 of Fig.1 described herein. Docket No. CYT-014-PCT
- Treatment device 100 can be configured as a handheld device, comprising a “handpiece” geometry.
- Console 500 can comprise user interface 510 as shown.
- user interface 510 is integral to treatment device 100.
- User interface 510 can be configured to allow a user (e.g., a technician) to set one or more microcoring parameters, such as depth of penetration of coring elements 155, density of coring (e.g., density of coring created by an array of one, two, three or more elements 155 of treatment module 150), and/or other coring and/or system 10 parameters.
- system 10 via user interface 510, is configured to provide an automated presentation of: pre- treatment setup steps of system 10; intra-treatment use of system 10; and/or post-treatment steps of system 10.
- Treatment device 100 can include one or more treatment modules 150, which can include a single coring element 155 or multiple coring elements 155 (e.g., three coring elements 155).
- treatment device 100 includes a kit 1500 of multiple treatment modules 150, such as a kit including at least one treatment module 150a each with a single coring element 155, and at least one treatment module 150b each with multiple (e.g., three) coring elements 155.
- a treatment module 150a with a single coring element 155 can be used to perform microcoring in one or more “hard to reach areas”, while treatment module 150b can be used to perform microcoring in skin surface areas that are larger (e.g., to reduce treatment time than that achievable via a treatment module 150a with a single coring element 155).
- Treatment module 150b can comprise an assembly of multiple (e.g., three) coring elements 155 that are positioned at least 1mm, at least 2mm, at least 3mm, and/or approximately 3.33mm apart (e.g., to reduce likelihood of skin “tenting” and/or to reduce slicing of skin).
- treatment module 150b can comprise an assembly of multiple (e.g., three) coring elements 155 that are positioned no more than 7mm apart, such as no more than 6mm apart, no more than 5mm apart, and/or no more than 4mm apart. [236] In some embodiments, treatment module 150b comprises an assembly of multiple (e.g., three) coring elements 155, where each element 155 comprises opposing lateral sides that terminate at the distal end of each element 155 in one or more sharpened edges that each define a cutting axis.
- the axes of the cutting edges of multiple (e.g., three) coring elements 155 are arranged in a non-linear arrangement, such as to prevent slicing and/or tearing of skin positioned between coring elements 155 during microcoring Docket No. CYT-014-PCT (e.g., slicing and/or tearing that might result from multiple linearly aligned cutting edges of relatively close proximity being inserted through the skin simultaneously).
- Treatment module 150 can comprise a single assembly that is attached to the remaining portion of treatment device 100, and it can include one or more mechanisms to prevent undesired movement of microcoring elements 155 when not attached.
- Treatment device 100 can include actuation assembly 120 which can include one or more actuators, such as x-actuator 121x, y-actuator 121y, and/or z-actuator 121z as shown.
- actuation assembly 120 includes x-actuator 121x and y-actuator 121y for positioning the coring elements 155 relative to one or more locations on the patient’s skin, and z-actuator 121z is configured to advance the elements 155 into the skin, such as is described in detail hereinbelow. This x-y positioning, and z-advancement can be repeated multiple times until a desired microcoring pattern is achieved.
- Actuators 121 can comprise motors, such as brushless DC motors, as well as a fine-pitched lead screw (e.g., a lead screw with a M3C0.5-6g thread).
- the lead screw can comprise a brass or other metal lead screw with a PEEK or other plastic projection that rides on the screw threads.
- Actuators 121 e.g., x-actuator 121x and y-actuator 121y
- Actuators 121 can comprise a motor with at least a 3:1 or 4:1 gear ratio.
- Actuators 121 can comprise one or more position sensors (e.g., functional elements 199a configured as position sensors), such as hall effect sensors.
- x-actuator 121x and/or y-actuator 121y include an optical gate-based position sensor.
- z-actuator 121z comprises a position sensor (e.g., a functional element 199a configured as a position sensor), such as a linear magnetic and/or optical encoder configured to determine the change in position of a translating component of actuator 121z (e.g., determine the change in position of the translating component of actuator 121z, such as to determine the acceleration, speed, and/or absolute position of advancement and/or retraction of coring elements 155 by actuator 121z).
- a position sensor e.g., a functional element 199a configured as a position sensor
- a linear magnetic and/or optical encoder configured to determine the change in position of a translating component of actuator 121z (e.g., determine the change in position of the translating component of actuator 121z, such as to determine the acceleration, speed, and/or absolute position of advancement and/or retraction of coring elements 155 by actuator 121
- z-actuator 121z comprises a position sensor that includes or is integral to a linear bearing, such as to ensure unimpeded motion of z-actuator 121z.
- System 10 can be configured to perform a microcoring of tissue by the clinician or other operator positioning a skin contacting surface (e.g., a frame as described herein) of treatment device 100 at a first tissue surface location.
- treatment module 150 e.g., including one or more coring elements 155, such as three coring elements 155) is advanced into tissue (e.g., via z-actuator 121z to a target depth); (2) treatment module 150 is withdrawn from the tissue (e.g., via z- Docket No. CYT-014-PCT actuator 121z); and (3) treatment module 150 is repositioned to a new location (e.g., via x- actuator 121x and/or y-actuator 121y).
- Steps 1 thru 3 can be performed a single time, or multiple times, such as at least 3, 8, 12, 17, and/or 20 times (e.g., with a three coring element 155 assembly), in order to perform a “treatment event”.
- a first treatment event is performed, one or more subsequent treatment events can be initiated.
- the operator positions the skin contacting surface (e.g., a frame as described herein) at a desired (e.g., new) tissue location, and one or more series of Steps 1 thru 3 are repeated.
- a switch e.g., a footswitch
- other control that is activated by an operator to initiate a treatment event, must remain activated (e.g., a footswitch must continue to be depressed) in order for the treatment event to continue to completion (e.g., of the one or more series of Steps 1 thru 3 that are repeated).
- the control is not maintained in an active state (e.g., a footswitch pedal is released)
- system 10 can be configured in the following arrangement: if Step 1 or Step 2 is in process, the treatment procedure continues thru completion of Step 2 (i.e.
- System 10 can include a limit on depth of travel of actuator 121z (e.g., limit depth of travel of a translating component of actuator 121z that translates along the z-axis), such as to limit depth of penetration of one or more coring elements 155 into skin (e.g., such as to avoid contact of a coring element 155 with a nerve, blood vessel, and/or bone).
- a limit on depth of travel of actuator 121z e.g., limit depth of travel of a translating component of actuator 121z that translates along the z-axis
- this depth of penetration is input by an operator (e.g., input into user interface 510), such as a depth of 3mm, 4mm, and/or 5mm of penetration into the patient’s skin.
- a titration or other iterative adjustment procedure is performed by an operator, in which depth of penetration is adjusted, such as to increase depth of penetration to achieve sufficient coring, and/or a decrease in depth of penetration (e.g., when treating an area in which element 155 contact with bone might otherwise result).
- System 10 can be configured to decelerate actuator 121z as the one or more microcoring elements 155 are approaching a target depth.
- Actuator 121z can be controlled by one or more algorithms of system 10 (e.g., algorithm 25) via one or more sets of instructions. Ranges of positions of a translating portion of actuator 121z range from a -z max to z max , with a rise time t r .
- the translating component of actuator 121z has a velocity, v, and a maximum velocity vmax, and an Docket No. CYT-014-PCT acceleration, a.
- the acceleration a of the translating component of actuator 121z can be controlled to approximate a smooth continuous function.
- the translating component of actuator 121z can have a z max equal to approximately 0.007m (0.7cm), and v max can be equal to approximately 1.0m/sec.
- Treatment device 100 can be void of any surface, projection, and/or other mechanical stop that is contacted by treatment module 150 during advancement of coring elements 155 in a microcoring procedure (e.g., no mechanical stop is used to limit advancement of coring elements 155 during a microcoring procedure). Avoidance of such a mechanical stop can provide numerous advantages, such as avoiding the vibration that occurs when a moving assembly makes contact with a mechanical stop (e.g., a vibration that can cause a degradation of tissue cores removed during a microcoring procedure).
- Treatment device 100 can comprise one or more sensors, such as sensor 199a shown.
- Console 500 can comprise one or more sensors, such as sensor 599a shown.
- Sensor 199a and/or 599a can comprise one or more sensors.
- Sensor 199a and/or 599a can comprise a pressure sensor, such as a pressure sensor configured to monitor a pressure level (e.g., a vacuum pressure level) of one or more conduits or other cavity portions of system 10.
- Sensor 199a and/or 599a can comprise one, two, or more sensors configured to monitor (e.g., constantly monitor during use) the position (e.g., the x, y, and/or z position) of actuation assembly 120 (e.g., monitor the position of an actuator 121).
- Sensor 199a and/or 599a can comprise one, two or more sensors configured to monitor the position of a component of system 10, such as the position of a component of an actuator 121.
- sensor 199a and/or 599a can comprise an encoder (e.g., a magnetic and/or optical encoder), such as an encoder that monitors the position of a component of actuator 121.
- an encoder e.g., a magnetic and/or optical encoder
- Docket No. CYT-014-PCT sensor 199a and/or 599a comprises a position sensor (e.g., an encoder) which monitors a position of a component with a resolution of 0.5mm or less.
- sensor 199a and/or 599a can comprise one or more position sensors (e.g., one or more encoders) that monitor the one or more positions of actuator 121x and/or 121y with a greater precision than 60 ⁇ m (e.g., a resolution of 60 ⁇ m or less), such as greater precision than 40 ⁇ m, such as a resolution of approximately 20 ⁇ m.
- position sensors e.g., one or more encoders
- 60 ⁇ m e.g., a resolution of 60 ⁇ m or less
- 40 ⁇ m such as a resolution of approximately 20 ⁇ m.
- sensor 199a and/or 599a can comprise one or more position sensors (e.g., one or more encoders) that monitor one or more positions of actuator 121z with a greater precision than 5 ⁇ m (e.g., a resolution of 5 ⁇ m or less), such as a greater precision than 4 ⁇ m, 3 ⁇ m, and/or 2 ⁇ m, such as a resolution of approximately 1 ⁇ m.
- system 10 is configured to constantly (e.g., always) determine and/or otherwise know the position of treatment module 150 and/or its coring elements 155 (e.g., constantly determine and/or otherwise know the x, y, and/or z positions of each element 155 during use).
- sensor 199a and/or 599a can comprise one, two, or more sensors configured to monitor (e.g., constantly monitor during use) the speed and/or the acceleration of actuation assembly 120 (e.g., monitor the speed and/or acceleration of an actuator 121).
- System 10 can comprise one or more position, speed, and/or acceleration limits (e.g., threshold above or below which operation is prevented or at least requires additional attention from an operator).
- System 10 can include a set of position, speed, and/or acceleration thresholds, such as for any actuator 121. Detection of any of these parameters outside of an expected range can result in system 10 entering a warning state, such as a state in which further operation is limited (e.g., microcoring is prevented) until further action is taken.
- system 10 can be configured to alarm if one of the following conditions are detected (e.g., as determined by signals provided by sensor 199a and/or 599a): intended depth of penetration of a microcoring element 155 not achieved; velocity profile of a microcoring element 155 motion outside of an intended window (e.g., element 155 does not reach an intended location within a time window); a microcoring element 155 at an undesired position; acceleration of a microcoring element 155 is above a threshold ; and combinations of these.
- intended depth of penetration of a microcoring element 155 not achieved
- velocity profile of a microcoring element 155 motion outside of an intended window e.g., element 155 does not reach an intended location within a time window
- a microcoring element 155 at an undesired position e.g., acceleration of a microcoring element 155 is above a threshold ; and combinations of these.
- Sensor 199a and/or 599a can comprise one or more sensors configured to monitor current, such as current applied to an actuator 121 (e.g., x- actuator 121x, y-actuator 121y, and/or z-actuator 121z).
- System 10 can be configured to monitor current value of current, peak current, and/or amount of current over time. Current above a threshold can correlate to an actuator 121 having to exert an undesired amount of force, and/or an actuator 121 being in a “stuck” position.
- Sensor 199a and/or 599a can comprise one or more sensors configured to detect a “locked” or “unlocked” status of Docket No.
- CYT-014-PCT treatment module 150 such as to prevent use (e.g., prevent microcoring) if treatment module 150 is not properly positioned in treatment device 100.
- System 10 can be configured to monitor repeated use of treatment module 150, such as when an upper limit of uses is applied by system 10.
- each treatment module 150 can comprise a unique identifier (e.g., an RFID or other identifier as described herein), and system 10 can keep track of uses of treatment module 150 such as to prevent repeated use above a threshold.
- system 10 is configured to monitor deceleration of actuator 121z, such as to reduce the likelihood of damage to one or more coring elements 155.
- Sensor 199a and/or 599a can comprise one or more sensors configured to detect a deceleration “fault”, in other words a detected level of deceleration that is outside of an expected range, and/or has repeatedly transitioned above one or more deceleration thresholds.
- a deceleration fault can indicate damage (e.g., hooked end, bent shaft, and the like) to one or more microcoring elements 155 may have occurred (e.g., due to hitting bone or other hard surface during advancement).
- System 10 can be configured to prevent further use until inspection by an operator is performed (e.g., and treatment module 150 is replaced or confirmation of no damage is provided by the operator).
- system 10 is configured to monitor the deceleration of a translating component of actuator 121z (e.g., the component causing coring elements 155 to advance into and retract from tissue), and if the monitored deceleration exceeds (e.g., at any time) a maximum threshold, D MAX , cause system 10 to enter an alarm state in which the operator is required to perform an action, such as: replacement of all or a portion of treatment module 150; inspection of treatment device 100 and/or another component of system 10; and/or performance of a safety and/or efficacy related task.
- DMAX comprises a deceleration level of no more than 75g, such as no more than 60g, such as a deceleration limit of approximately 50g.
- system 10 has multiple deceleration thresholds, such as a D MAX (e.g., as described hereinabove), as well as one, two or more other, lower thresholds, such as a D1, and/or a D2 deceleration threshold, such as when D2 is greater than D1.
- System 10 e.g., algorithm 25
- System 10 can be configured to record the number of times actuator 121z exceeds either or both thresholds, and to enter an alarm state (e.g., a state in which use of system 10 is stopped until further action is performed as described hereinabove), and/or to enter an alert state (e.g., a state in which use of system 10 can continue, but the operator is notified of the exceeding of the threshold).
- D1 comprises a threshold of no more than 40g, such as no more than 35g, or approximately 32g, and system 10 enters an alert state Docket No. CYT-014-PCT if deceleration of actuator 121z exceeds D1.
- system 10 enters an alert and/or an alarm state (e.g., as described hereinabove) if a difference in deceleration (e.g., between two or more advancements of actuator 121z) exceeds a threshold (e.g., one advancement has a deceleration that exceeds a previous advancement by a threshold level).
- monitoring of deceleration of actuator 121z is used to automatically adjust the depth of penetration (e.g., depth of advancement) of element 155.
- system 10 includes one or more sensors configured to monitor for inadequate communication (e.g., loss of communication) between two or more components of system 10 (e.g., between treatment device 100 and console 500).
- System 10 e.g., console 500 and/or treatment device 100
- system 10 is configured to adjust (e.g., automatically adjust) the depth of penetration of coring elements 155 based on deceleration of actuator 121z (e.g., such as when system 10 records, stores, and/or otherwise monitors the deceleration of actuator 121z).
- Accessories 90 can include various accessory components, such as a power cord (e.g., to attach to wall power), one or more filters, suction tubing, and/or other accessory components.
- Accessories 90 can include a footswitch, such as an operator-controlled footswitch configured to initiate and/or stop microcoring or other function of system 10.
- Functional element 599 of console 500 and/or functional element 199 of treatment device 100 can comprise a data transmission module, such as a cellular or other wireless transceiver, and/or a wired connection transceiver.
- System 10 can be configured to transmit system 10 use and/or other recorded information (e.g., data logs) to a remote site (e.g., the cloud, the system 10 manufacturer’s location, a data collection service, and the like) via the transceiver, such as to collect, process, and/or analyze data collected by one or more systems 10 that are in use at one or more settings in which a system 10 is used.
- system 10 comprises a treatment module 150 comprising one or more coring elements 155, and an actuation assembly 120 that is operably attached to treatment module 150.
- Actuation assembly 120 and one or more other components of system 10 can be configured to perform a microcoring procedure comprising the treatment module 150 translating in a series of “reciprocating motions”, each reciprocating motion comprising each coring element 155 being inserted into and withdrawn from tissue of the patient, such as to provide a cosmetic effect to the patient.
- the series of reciprocating motions comprises at least one reciprocating motion.
- the series of reciprocating motions can comprise at least two Docket No.
- actuation assembly 120 is further configured to translate the treatment module 150 in one or more directions relative to a surface of skin tissue of the patient, such as in two orthogonal directions (e.g., in an x-y positioning arrangement as described herein, in which after each x-y positioning, the one or more coring elements are advanced and retracted along a z-axis in a reciprocating motion).
- system 10 is configured to perform the series of reciprocating motions based on one, two, or more parameters associated with the reciprocating motion.
- These one, two, or more “reciprocating motion parameters” can comprise parameters selected from the group consisting of: insertion speed; insertion acceleration; insertion rise time; insertion dwell time; insertion fall time; insertion force; withdrawal speed; withdrawal acceleration; withdrawal force; core diameter; depth of insertion; microcoring density; microcoring pattern; lateral movement speed; lateral movement direction; lateral movement vector; lateral movement height; microcoring location; microcoring location tolerance; deceleration threshold; undershoot threshold; overshoot threshold; vacuum actuation release delay; vacuum release duration; and combinations thereof.
- System 10 can comprise reciprocating motion parameters, and at least one reciprocating motion parameter can be adjustable by an operator. In some embodiments, at least one reciprocating motion parameter can be automatically adjusted by system 10. [256] In some embodiments, system 10 is configured to assess coring depth. Assessment can comprise an assessment of the depth of a previously captured core, and/or a core to potentially be captured in the future. System 10 can comprise a sensor (e.g., one, two, or more sensor-based functional elements 99 and/or 199) that can be configured to produce a signal, and system 10 can be configured to assess the coring depth based on the sensor signal.
- a sensor e.g., one, two, or more sensor-based functional elements 99 and/or 199
- the sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof.
- system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) an algorithm, algorithm 25 shown, and algorithm 25 can be configured to perform the coring Docket No. CYT-014-PCT depth assessment.
- algorithm 25 can comprise one or more machine learning, neural network, and/or other artificial intelligence algorithms (“AI algorithm” herein).
- the assessment can comprise providing an optimized depth for coring.
- System 10 can be configured to automatically adjust the coring depth based on the assessment.
- system 10 can be configured to provide coring depth feedback to the operator based on the assessment.
- the coring depth feedback can comprise a suggested depth for coring.
- the feedback can comprise a “too deep” warning when the assessment indicates depth of coring has been above a threshold.
- system 10 is configured to detect whether a core has been captured in at least a first coring element of the one or more coring elements 155.
- System 10 can be configured to detect whether a core has been captured in each of the one or more coring elements 155.
- System 10 can comprise a sensor (e.g., one, two, or more sensor- based functional elements 99 and/or 199) that can be configured to produce a signal, and system 10 can be configured to detect whether a core has been captured based on the sensor signal.
- the sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof.
- system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the determination of whether the core has been captured.
- System 10 can comprise one or more reciprocating motion parameters, and algorithm 25 can be further configured to correlate the likelihood of future core captures to a reciprocating motion parameter.
- algorithm 25 can comprise an AI-based algorithm, as described herein.
- System 10 can be configured to automatically adjust a reciprocating motion parameter if a sufficient core cannot be detected as having been captured.
- the one, two, or more reciprocating motion parameters that are adjusted can comprise parameters selected from the group consisting of: insertion speed; insertion acceleration; insertion rise time; insertion dwell time; insertion fall time; insertion force; withdrawal speed; withdrawal acceleration; withdrawal force; core diameter; depth of insertion; microcoring density; microcoring pattern; lateral movement speed; lateral movement direction; lateral movement vector; lateral movement height; microcoring location; microcoring location tolerance; deceleration threshold; undershoot threshold; Docket No. CYT-014-PCT overshoot threshold; vacuum actuation release delay; vacuum release duration; and combinations thereof.
- system 10 is configured to assess the quality of a captured core.
- System 10 can comprise a sensor (e.g., one, two, or more sensor-based functional elements 99 and/or 199) that can be configured to produce a signal, and system 10 can be configured to assess the quality of the captured core based on the sensor signal.
- the sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof.
- System 10 can comprise a handpiece that includes actuation assembly 120, and the sensor can be positioned in the handpiece.
- system 10 can include sensing device 40 as shown, such as a sensing device that does not include actuation assembly 120, and where the sensor (e.g., functional element 99) configured to detect the captured core is positioned in sensing device 40.
- system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the assessment of the core quality.
- algorithm 25 can comprise an AI-based algorithm, as described herein.
- Algorithm 25 can be configured to provide a coring score representing the quality of the captured core (e.g., a coring score provided to an operator of system 10, such as via a display of console 500, display 511 shown, or other display, speaker, and/or other output component of system 10).
- system 10 is configured to identify the tissue type and/or a tissue property of tissue of a captured core, tissue of a target tissue location, or both.
- System 10 can comprise a sensor (e.g., one, two, or more sensor-based functional elements 99 and/or 199) that can be configured to produce a signal, and system 10 can be configured to identify the tissue type and/or tissue property based on the sensor signal.
- the sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof.
- system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can Docket No. CYT-014-PCT store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the identification of the tissue type and/or tissue property.
- algorithm 25 can comprise an AI-based algorithm, as described herein.
- System 10 can be configured to identify one, two, or more tissue types selected from the group consisting of: skin tissue; fat tissue; muscle tissue; blood vessel wall tissue; blood; scar tissue; and combinations thereof.
- System 10 can comprise one or more reciprocating motion parameters, and system 10 can be configured to adjust a reciprocating motion parameter based on the identified tissue type and/or tissue property.
- the one, two, or more reciprocating motion parameters that are adjusted can comprise parameters selected from the group consisting of: insertion speed; insertion acceleration; insertion rise time; insertion dwell time; insertion fall time; insertion force; withdrawal speed; withdrawal acceleration; withdrawal force; core diameter; depth of insertion; microcoring density; microcoring pattern; lateral movement speed; lateral movement direction; lateral movement vector; lateral movement height; microcoring location; microcoring location tolerance; deceleration threshold; undershoot threshold; overshoot threshold; vacuum actuation release delay; vacuum release duration; and combinations thereof.
- System 10 can be configured to reduce insertion depth if the identified tissue type comprises fat tissue.
- System 10 can be configured to increase insertion force if the identified tissue type comprises scar tissue.
- the System 10 can be configured to modify a reciprocating motion parameter if an undesired and/or unexpected tissue type and/or tissue property is identified.
- the one, two, or more reciprocating motion parameters that are adjusted can comprise parameters selected from the group consisting of: insertion speed; insertion acceleration; insertion rise time; insertion dwell time; insertion fall time; insertion force; withdrawal speed; withdrawal acceleration; withdrawal force; core diameter; depth of insertion; microcoring density; microcoring pattern; lateral movement speed; lateral movement direction; lateral movement vector; lateral movement height; microcoring location; microcoring location tolerance; deceleration threshold; undershoot threshold; overshoot threshold; vacuum actuation release delay; vacuum release duration; and combinations thereof.
- System 10 can be configured to enter an alert state if an undesired and/or unexpected tissue type and/or tissue property is captured and/or identified in a target tissue location.
- system 10 is configured to detect the force of an insertion of a coring element 155, the force of a withdrawal of a coring element 155, or both.
- System 10 can comprise a sensor (e.g., one, two, or more sensor-based functional elements 99 and/or 199) that can be configured to produce a signal, and system 10 can be configured to Docket No. CYT-014-PCT detect the force based on the sensor signal.
- the sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; and combinations thereof.
- system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the force detection.
- algorithm 25 can comprise an AI-based algorithm, as described herein.
- System 10 can be configured to adjust the depth of insertion if an undesired force is detected.
- System 10 can be configured to enter an alert state if the detected force exceeds a threshold.
- System 10 can be configured to perform an initial insertion and/or withdrawal and detect the associated force, and then adjust the insertion and/or withdrawal force in subsequent reciprocating motions of coring elements 155.
- system 10 is configured to set a depth of insertion of the one or more coring elements 155. The depth of insertion can be set based on a tissue analysis performed by system 10.
- System 10 can comprise a sensor (e.g., one, two, or more sensor- based functional elements 99 and/or 199) that can be configured to produce a signal, and system 10 can be configured to perform the tissue analysis based on the sensor signal.
- the sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof.
- system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the tissue analysis.
- algorithm 25 can comprise an AI-based algorithm, as described herein.
- system 10 is configured to detect the presence of a critical structure at a target tissue location.
- System 10 can comprise a sensor (e.g., one, two, or more sensor-based functional elements 99 and/or 199) that can be configured to produce a signal, and system 10 can be configured to perform the detection of the presence of the critical structure based on the sensor signal.
- the sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; Docket No.
- CYT-014-PCT accelerometer can comprise an imaging device (e.g., imaging device 50 described herein), and the imaging device can comprise one, two, or more devices selected from the group consisting of: ultrasound imaging device; X-ray imaging device, such as a fluoroscope; OCT imaging device; and combinations thereof.
- system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the detection of the presence of the critical structure.
- algorithm 25 can comprise an AI-based algorithm, as described herein.
- the critical structure can comprise a structure selected from the group consisting of: blood vessel tissue; bone; scar tissue; damaged tissue, such as burned tissue; and combinations thereof.
- System 10 can comprise one or more reciprocating motion parameters, and system 10 can be configured to adjust a reciprocating motion parameter to avoid inserting the one or more coring elements 155 into the detected critical structure.
- System 10 can be configured to automatically reduce the depth of insertion based on the detection of the critical structure.
- System 10 can be configured to enter an alert state when a critical structure can be detected.
- system 10 is configured to mark tissue, such as target tissue, non-target tissue, and/or safety margin tissue.
- System 10 can comprise marking element 91 shown, such as a marking element that is configured to mark tissue.
- Marking element 91 can comprise one, two, or more marking elements configured to mark tissue with ink, dye, and/or energy such as laser energy.
- System 10 can be configured to mark tissue to identify a no coring area (e.g., a non-target tissue area), and the no coring area can comprise a tissue surface portion to which microcoring should be avoided.
- the no coring area can comprise a first tissue surface portion and a second tissue surface portion, such as portions to which microcoring should be avoided.
- System 10 can be configured to prevent coring in tissue locations marked as non-target tissue by system 10.
- the treatment module 150 can comprise a spacer, spacer assembly 180 described herein, that includes a window, window 182 shown, and system 10 can be configured to perform multiple reciprocating motions of the one or more coring elements 155 within window 182 of spacer assembly 180.
- System 10 can be further configured to avoid inserting the coring elements 155 in tissue that has been marked by system 10 as non-target tissue that should not be cored.
- System 10 can be configured to mark the tissue with a marking pattern that is indicative of non-target tissue. Docket No. CYT-014-PCT System 10 can be configured to core tissue that has been marked by system 10 as target tissue.
- System 10 can be configured to perform multiple reciprocating motions of the one or more coring elements 155 within window 182 of spacer assembly 180, and system 10 can be further configured to insert the coring elements 155 in tissue that has been marked by system 10 for coring (e.g., marked as target tissue).
- System 10 can be configured to mark the tissue with a marking pattern that is indicative of target tissue.
- system 10 is configured to mark target tissue with a first marking pattern and to mark non-target tissue with a second marking pattern different than the first marking pattern.
- system 10 can be configured to perform multiple reciprocating motions of the one or more coring elements 155 within window 182 of spacer assembly 180, and system 10 can be further configured to insert the coring elements 155 in tissue that has been marked by system 10 with the first pattern and to avoid inserting the coring elements 155 in tissue that has been marked by system 10 with the second pattern.
- system 10 is configured to record skin surface data.
- the skin surface data can comprise photographs and/or other images of the skin surface (e.g., images that are produced by one or more components of system 10).
- System 10 can be configured to record skin surface data prior to a microcoring procedure and/or after a microcoring procedure.
- system 10 is configured to record skin surface data both prior to a microcoring procedure and after a microcoring procedure.
- system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform an analysis of microcoring effectiveness based on a comparison of the skin surface data recorded prior to the microcoring procedure and after the microcoring procedure.
- System 10 can be configured to record skin surface data prior to a microcoring procedure, and algorithm 25 can be configured to produce a microcoring treatment plan (e.g., an initial treatment plan) based on the skin surface data recorded prior to the microcoring procedure.
- a microcoring treatment plan e.g., an initial treatment plan
- system 10 comprises diagnostic assembly 30 shown, such as a diagnostic assembly configured as a self-diagnostic assembly that performs a diagnostic on one or more components of system 10. Diagnostic assembly 30 can be configured to detect damage to a component of system 10. Diagnostic assembly 30 can comprise one or more sensors, sensor 39 shown, such as an acceleration sensor, impact sensor, and/or other Docket No. CYT-014-PCT sensor configured to produce a signal representative of damage to the component of system 10 being monitored for damage.
- diagnostic assembly 30 shown, such as a diagnostic assembly configured as a self-diagnostic assembly that performs a diagnostic on one or more components of system 10. Diagnostic assembly 30 can be configured to detect damage to a component of system 10. Diagnostic assembly 30 can comprise one or more sensors, sensor 39 shown, such as an acceleration sensor, impact sensor, and/or other Docket No. CYT-014-PCT sensor configured to produce a signal representative of damage to the component of system 10 being monitored for damage.
- system 10 comprises a user interface, such as user interface 510 and/or another user interface of system 10, and the user interface is configured to allow an operator to select a microcoring pattern to be used in a microcoring procedure.
- the microcoring pattern can be selected from a set of microcoring patterns made available by system 10, such as microcoring parameters presented on display 511 or other display of system 10.
- system 10 comprises one or more user interfaces, collectively including a first input device, input device 512 shown (e.g., a touch screen of user interface 510) and a second input device.
- the second input device can comprise input device 104 of treatment device 100 and/or input device 513 of user interface 510, each as shown.
- system 10 can be configured to receive commands from an operator from either or both of first input device 512 (e.g., a touch screen), as well as input device 104 and/or input device 513.
- Input device 104 and/or input device 513 can comprise a microphone (e.g., a microphone configured to receive commands from an operator of system 10).
- System 10 can comprise a handpiece (e.g., housing 110 comprises a hand-held housing) comprising treatment module 150, and input device 104 can be positioned on the handpiece (e.g., on housing 110).
- System 10 can comprise one or more reciprocating motion parameters, and one, two, or all of input device 512 (e.g., a touch screen), input device 104 and/or input device 513, can be configured to allow an operator to adjust one or more (e.g., all) of the adjustable reciprocating motion parameters.
- system 10 comprises a display, display 511 shown, and system 10 is configured to provide “microcoring feedback information” on the display.
- This feedback information can comprise data selected from the group consisting of: core size data, such as detected core size data; coring element 155 reciprocating motion data; target tissue data; non-target tissue data; and combinations thereof.
- System 10 can be configured to provide the microcoring feedback information as video on display 511.
- the one or more coring elements 155 comprise multiple coring elements 155 arranged in a grid of at least one row and at least two columns. Each pair of neighboring columns can be separated by a distance L1, and actuation assembly 120 can be configured to: perform a first reciprocating motion of the multiple coring elements Docket No. CYT-014-PCT 155; translate the multiple coring elements 155 a distance LT that is a distance less than L1; and then perform a second reciprocating motion of the multiple coring elements 155.
- System 10 can be configured to translate the multiple coring elements 155 in a direction approximately 45 degrees relative to the axis of the columns.
- System 10 can be configured to translate the multiple coring elements 155 in a direction relatively orthogonal to the axis of the columns.
- the orthogonal distance translated can comprise a distance of approximately half of L1.
- system 10 can be configured to translate the multiple coring elements 155 a distance (e.g., an orthogonal distance) of approximately 1.5 times L1, and then perform a third reciprocating motion of the multiple coring elements 155.
- system 10 can be configured to translate the multiple coring elements 155 a distance (e.g., an orthogonal distance) of approximately half of L1, and then perform a fourth reciprocating motion of the multiple coring elements 155.
- the grid can comprise at least two rows, where each pair of neighboring rows can be separated by a distance L2, and the distance LT can comprise a distance that can be greater than L1 and greater than L2.
- the number of columns of the grid can comprise a quantity that can be at least three times the number of rows of the grid.
- the one or more coring elements 155 comprises an array of at least ten coring elements 155.
- the one or more coring elements 155 comprises an array of at least 100 coring elements 155.
- system 10 can comprise a spacer, such as spacer assembly 180 described herein, and spacer assembly 180 can apply a vacuum (e.g., via vacuum assembly 560 shown) to a tissue surface being treated by system 10.
- System 10 can be configured to: apply the vacuum while spacer assembly 180 can be positioned on the patient’s skin at a first location L1; deliver a series of multiple reciprocating motions of the one or more coring elements 155; wait a pre-determined time period T1; and then release the vacuum for a pre-determined time period T2.
- Spacer assembly 180 can be configured to be repositioned at a second patient skin location L2 during time period T2. Alternatively or additionally, spacer assembly 180 can be configured to be repositioned at a second patient skin location L2 after time period T2 has elapsed.
- System 10 can comprise a first vacuum source and a second vacuum source, and the first vacuum source can apply a vacuum to spacer assembly 180, and the second vacuum source can apply a vacuum that removes cores from the one or more coring elements 155.
- System 10 can be configured to provide the vacuum to spacer assembly 180 at a first level, a second level, or both.
- CYT-014-PCT 560 can comprise a first vacuum source 560a configured to provide vacuum at a first level, and a second vacuum source 560b configured to provide vacuum at a second level, and the second level can be different than the first level.
- the first vacuum source 560a and the second vacuum source 560b can be each configured to be detached from, and/or operably attached to, the treatment module 150.
- Spacer assembly 180 can comprise: a curved skin- contacting surface; a compressible skin-contacting surface; and/or a flexible skin contacting surface.
- spacer assembly 180 and one or more other components of system 10 can be configured to treat the neck of the patient.
- the one or more coring elements 155 can comprise a single coring element 155.
- system 10 comprises a console, console 500 shown and described herein, that operably attaches to the treatment module 150 and/or actuation assembly 120.
- Console 500 can comprise a motion detection sensor, such as a sensor that produces a signal indicative of console 500 being moved (e.g., between rooms of an office, a hospital, and/or other setting in which system 10 is used, in a desired or undesired fashion).
- system 10 comprises a projection assembly, projection assembly 93 shown, which can be configured to project an image of a microcoring pattern onto a skin surface portion of the patient (e.g., onto the face, neck, or other body portion of a patient).
- Projection assembly 93 can be integral to the treatment module 150, actuation assembly 120, or both.
- Projection assembly 93 can comprise a discrete component of system 10.
- Projection assembly 93 can comprise a laser configured to produce the image of the microcoring pattern.
- projection assembly 93 projects an image representing target tissue, safety margin tissue, and/or non-target tissue onto a skin surface of the patient.
- system 10 comprises a skin scanning assembly, scanner 94 shown, configured to scan the surface of one or more skin surface portions of the patient.
- System 10 can comprise a display, display 511 shown, and the scanner 94 can be configured to provide one or more images of the one or more skin surface portions on display 511.
- System 10 can be configured to allow an operator to mark target tissue to be treated and/or non-target tissue not to be treated, on at least one image provided by scanner 94 on display 511.
- System 10 can be configured to prevent microcoring in the tissue marked as non-target tissue.
- System 10 can be configured to automatically perform microcoring in the tissue marked as target tissue.
- system 10 comprises a coring element position tracking assembly, tracking assembly 95 shown, and tracking assembly 95 can be configured to track Docket No. CYT-014-PCT the translation of the treatment module 150 (e.g., coring elements 155) along a skin surface.
- Tracking assembly 95 can comprise one or more sensors (e.g., an optical sensor and/or other sensor-based functional element 99) that can be configured to detect texture changes in a skin surface. Tracking assembly 95 can be configured to determine when a desired translation distance and/or a translation distance threshold has been reached.
- system 10 comprises one or more skin treatment and/or other skin modifying devices, skin modification device 900 shown.
- skin modification device 900 comprises a skin-compressing dressing, such as is described in applicant’s co-pending United Stats Patent Application Serial Number 17/987,190, entitled “Methods and Devices for Skin Tightening”, filed November 15, 2022.
- Skin modification device 900 can comprise one or more agents and/or devices configured to modify the properties of skin, and/or to modify the properties of other tissue types proximate to skin.
- system 10 comprises an agent delivery assembly, agent delivery assembly 200 shown, and agent delivery assembly 200 can be configured to deliver an agent (e.g., agent 60 described herein) to one or more target tissue locations.
- Agent delivery assembly 200 can comprise one or more agent delivery elements, agent delivery element 201 shown.
- the one or more agent delivery elements 201 can comprise one or more elements selected from the group consisting of: needle; fluid jet; iontophoretic element; and combinations thereof.
- System 10 can comprise a first cartridge, cartridge 2011 shown, that includes the one or more agent delivery elements 201.
- Cartridge 2011 can be configured to operably attach to the treatment module 150.
- cartridge 2011 also includes the one or more coring elements 155 of treatment module 150.
- system 10 can further comprise a second cartridge (not shown but such as a cartridge of treatment module 150) that includes the one or more coring elements 155.
- At least one of the one or more coring elements 155 can comprise at least one of the one or more agent delivery elements 201 (e.g., a single needle or other component both cores tissue and delivers an agent).
- the one or more coring elements 155 can comprise at least two coring elements 155, and the at least two coring elements 155 can comprise all of the one or more agent delivery elements 201.
- System 10 can be configured to insert the one or more coring elements 155 at a first insertion rate profile and to insert the at least one agent delivery element 201 at a second insertion rate profile, and the first insertion rate profile can be different than the second insertion rate profile.
- the two insertion rate profiles Docket No. CYT-014-PCT can comprise different velocities, accelerations, wait times, and the like.
- System 10 can be configured to insert the at least one agent delivery element 201 into tissue, wait for a time period T1, and withdraw the at least one agent delivery element 201 from tissue.
- the at least one agent delivery element 201 can comprise an elongate shaft with a distal end, and the at least one agent delivery element 201 can comprise one or more agent delivery openings positioned at the distal end and/or proximal to the distal end (e.g., a side hole of the shaft).
- System 10 can comprise an agent (e.g., agent 60 described herein) to be delivered by the agent delivery assembly 200.
- agent 60 can comprise one, two, or more agents selected from the group consisting of: an analgesic agent, such as lidocaine; epinephrine; an antibiotic agent; an antifungal agent; a cooling agent; a warming agent; a dye; a radiographic agent; an ultrasonically visible agent; and combinations thereof.
- the agent 60 comprises a dermal filler to be delivered by agent delivery assembly 200.
- system 10 comprises tissue cooling assembly 92 shown, such as an assembly configured to reduce the temperature of one or more surfaces and/or volumes of tissue of the patient.
- System 10 can be configured to cool (e.g., via tissue cooling assembly 92) at least a target tissue location at a time prior to performing a microcoring procedure, during a microcoring procedure, and/or after a microcoring procedure.
- the treatment module 150 and/or actuation assembly 120 can comprise tissue cooling assembly 92.
- Tissue cooling assembly 92 can comprise a separate component, such as a mask configured to be placed on the patient’s face and extract heat from tissue.
- treatment module 150 and actuation assembly 120 comprise a first system 10a, and system 10 further comprises: a second system 10b, not shown but comprising: a second treatment module 150’ comprising a one or more coring elements 155’; and a second actuation assembly 120’ operably attached to the second treatment module 150’ and configured to perform a microcoring procedure comprising the second treatment module 150’ translating in a series of reciprocating motions, each reciprocating motion comprising each coring element 155’ being inserted into and withdrawn from tissue of a patient.
- a server 20 (e.g., a server connected to network 80 described herein, such as the Internet or privately maintained network) can be configured to receive information from the first system 10a and the second system 10b.
- System 10 can be Docket No. CYT-014-PCT configured to update the first system 10a based on at least information received from the second system 10b.
- system 10 comprises multiples of one or more of: treatment device 100; console 500; and/or other components of system 10 described herein.
- one or more of the components of system 10 can be maintained at multiple clinical sites. and these components can communicate (e.g., via a wired or wireless connection via network 80) with each other, and/or with server 20.
- each clinical site performing the microcoring and other procedures of the present inventive concepts can include one or more microcoring subsystems 11, such as microcoring subsystem 11a, 11b, 11c through 11n as shown.
- Each microcoring subsystem 11 can include at least one treatment device 100 (e.g., including one or more actuation assemblies 120), and multiple treatment modules 150 (e.g., multiple treatment modules 150 that are used in multiple clinical procedures on multiple patients).
- Each microcoring subsystem 11 can include one or more consoles 500, and one or more of the other components shown in Fig.1.
- a single network 80 connects multiple microcoring subsystems 11 to each other, and/or to server 20, such as to transfer data between system 10 components at different clinical sites with other clinical sites and/or with server 20 (e.g., via a wired or wireless connection via network 80).
- System 10 can comprise one or more devices for patients, clinicians, and/or vendors, (singly or collectively, “users” herein) to enter information into system 10, and/or receive information from system 10.
- system 10 can comprise one or more of each of: patient device 300, clinician device 400, and/or vendor device 700, respectively, each as shown.
- Each of patient device 300, clinician device 400, and/or vendor device 700 can comprise one, two, or more devices selected from the group consisting of: phone; cell phone; smart phone; computer; laptop computer; tablet computer; smart watch; automobile communication device; a patient-monitoring device (e.g., as described herein); and combinations of these.
- Each device 300, 400, and/or 700 can each comprise one or more applications (e.g., software applications), patient application 320, clinician application 420, and/or vendor application 720, respectively, as shown.
- Devices 300, 400, and/or 700 can each comprise a user interface, user interface 350, clinician interface 450, and/or vendor interface 750, respectively, as shown.
- Devices 300, 400, and/or 700 can each comprise one or more functional elements, such as functional element 399, functional element 499, and/or functional element 799, respectively, as shown.
- System 10, and/or Docket No. CYT-014-PCT each subsystem 11 can comprise multiple patient devices 300, multiple clinician devices 400, and/or multiple vendor devices 700, that are used by multiple patients, clinicians, and/or vendors, respectively, the multiple patients, clinicians, and/or vendors associated with an associated subsystem 11 and/or system 10.
- Devices 300, 400, and/or 700 can each comprise one, two, or more desktop and/or handheld electronic devices.
- Functional elements 399, 499, and/or 799 can each comprise a component configured to provide a connection (e.g., a wired or wireless connection) to the Internet or other computer network, network 80 shown, such as to provide communication access to server 20 of system 10.
- a connection e.g., a wired or wireless connection
- network 80 shown such as to provide communication access to server 20 of system 10.
- Each device 300/400/700 can be configured to operate in multiple modes of operation, such as multiple modes related to a level of complexity of use (e.g., easy, moderate, and advanced levels of operation), such as to correlate with experience, intelligence, and/or other parameter of a user of device 300/400/700.
- a user of a device 300/400/700 utilizes the device with a different level of “involvement”, such as when a first patient uses a device 300a with a first level of involvement (e.g., a minimal level of involvement), and a second patient uses a device 300b with a second level of involvement (e.g., a high level of involvement).
- patient device 300 is configured to operate in a “parent/guardian” mode, such as when the device 300 is being used by a parent and/or guardian of a patient which has received, and/or may in the future receive, a microcoring treatment via treatment device 100.
- System 10 can be configured to record (e.g., and store in memory) various information related to the patient, patient data PD or data PD described herein.
- Data PD can be received from: the patient; a family member of the patient (e.g., when the patient is a minor); one or more clinicians of the patient; a phone or other device of the patient; and/or by other information sources or devices.
- Data PD can comprise various information related to the patient’s current location (e.g., via a phone or other GPS enabled device), the patient’s home, and/or office location.
- Data PD can include patient demographic and physiologic information, and/or other patient information, such as patient data including but not limited to: patient image data; patient lifestyle data; patient medical history data (e.g., data related to one or more infections previously encountered by the patient); age data; race data; sex data; weight data; body mass index data; skin quality and/or other skin characterization data; Docket No.
- patient data including but not limited to: patient image data; patient lifestyle data; patient medical history data (e.g., data related to one or more infections previously encountered by the patient); age data; race data; sex data; weight data; body mass index data; skin quality and/or other skin characterization data; Docket No.
- CYT-014-PCT patient health data patient allergy data; data related to a previous microcoring procedure; data related to a previous surgical and/or other clinical procedure; DNA and/or other genetic data; data related to medications taken by the patient; patient diet data; patient location data (e.g., data related to the patient’s home or other location associated with the patient); patient travel data; patient occupation data; patient financial data; data related to one or more clinicians in the relative proximity (e.g., within 10, 20, or 30 miles) of the home or other associated location of the patient; and/or data related to one or more drug stores in the relative proximity (e.g., within 10, 20, or 30 miles) of the home or other associated location of the patient.
- system 10 is configured to allow a user (e.g., the patient) to set a distance to be used in calculations involving relative proximity to a patient location.
- Data PD can comprise data related to desired outcomes of the patient (e.g., desired outcomes provided by the patient, a clinician of the patient, or both).
- Data PD can comprise various information related to the patient, as described herein.
- System 10 can be configured to record (e.g., and store in memory) various information related to a clinician, clinician data CD or data CD herein.
- Data CD can be received from the clinician or other source.
- Data CD can comprise various information related to the clinician, such as: clinician office location; clinician current location information; clinician accreditations; clinician procedures offered; clinician procedure performance information; and/or other clinician information.
- System 10 can be configured to record (e.g., and store in memory) various information related to a vendor, vendor data VD or data VD herein.
- the vendor can be a manufacturer and/or distributor of one or more skincare, healthcare, and/or other patient and/or clinician available products.
- the vendor can be a business partner of, and/or otherwise have a business arrangement with, the manufacturer of system 10.
- Data VD can be received from the vendor or other source.
- Data VD can comprise various information related to the vendor, such as: vendor location; products offered; prices of products; and/or other vendor information.
- System 10 can be configured to record, monitor, and/or store system data SD or data SD herein.
- System data SD can include information selected from the group consisting of: current revisions of software and/or hardware of one or more components of system 10; system 10 use information; system 10 location information; system 10 age information; and combinations of these.
- system 10 is configured to record (e.g., and store in memory) information from a patient via a patient device 300, patient provided data PPD or Docket No. CYT-014-PCT data PPD herein.
- Data PPD can comprise various patient-provided patient information, such as one or more forms of data PD described herein, and/or other information provided by the patient.
- Data PPD can comprise data CD (e.g., a preferred clinician of the patient) and/or data VD (e.g., a preferred vendor of the patient).
- Patient device 300 can include one or more data recording components, such as a user interface 350 comprising one or more data recording components.
- user interface 350 can comprise a camera, a microphone, a keyboard, a touchscreen, a mouse, a joystick, and/or other user input component configured to record (e.g., and store in memory) data from a patient and/or a patient’s guardian, family member, and/or friend (“patient” herein).
- a patient device 300 comprises one, two, or more patient-monitoring devices (e.g., devices that monitor, record, analyze, and/or store data related to the patient), such as one, two, or more devices selected from the group consisting of: camera or camera system (e.g., a camera configured to record images of the patient’s face or other patient tissue); exercise monitoring device; sleep monitoring device; sleep apnea monitoring device; EKG and/or other heart monitoring device; EEG and/or other brain monitoring device; blood pressure monitoring device; blood glucose-monitoring device; implanted sensor device; other health-monitoring device; a patient location device (e.g., a device including a GPS sensor); and combinations of these.
- camera or camera system e.g., a camera configured to record images of the patient’s face or other patient tissue
- exercise monitoring device e.g., a camera configured to record images of the patient’s face or other patient tissue
- sleep monitoring device sleep apnea monitoring device
- system 10 is configured (e.g., via algorithm 25, for example an AI Algorithm) to manipulate and/or otherwise analyze patient data PD obtained from a camera to predict potential outcomes (e.g., efficacy potential) of a future microcoring procedure to be performed on the patient.
- potential outcomes e.g., efficacy potential
- data PD from multiple patients is analyzed by system 10 (e.g., via algorithm 25) to profile and/or identify one or more patients that are predicted to have desired (e.g., optimized and/or otherwise desirable by the patient) outcomes (e.g., of a microcoring procedure performed by system 10).
- the data PD is used by system 10 (e.g., via algorithm 25, for example an AI algorithm) to identify patients with similar demographic and/or clinical profiles, such as to share outcomes achieved by other patients with similar profiles.
- user interface 350 comprises a camera configured to record data PD (e.g., data PPD) comprising one or more photographs of the patient (e.g., one or more “selfies”), image data ID described herein.
- data PD e.g., data PPD
- These patient images can be transmitted (e.g., via network 80) to one or more clinicians (e.g., to a user interface 450 of a clinician device 400), such as to enable the clinician to assess a previous or future microcoring procedure performed using treatment device 100.
- the patient images can be transmitted to console 500 and/or server 20, such that an algorithm of system Docket No. CYT-014-PCT 10 can analyze the images (e.g., images of skin portions to be treated and/or skin portions already treated using treatment device 100) to determine tissue treatment parameters to be used in one, two, or more future microcoring procedures to be performed using treatment device 100, and/or to determine continued other treatments to be performed (e.g., medications given and/or skin and/or other tissue treatments performed) as part of post-microcoring treatment plan undertaken after a microcoring procedure using treatment device 100 is performed.
- images e.g., images of skin portions to be treated and/or skin portions already treated using treatment device 100
- tissue treatment parameters e.g., images of skin portions to be treated and/or skin portions already treated using treatment device 100
- continued other treatments to be performed e.g., medications given and/or skin and/or other tissue treatments performed
- user interface 350 comprises a text or voice capturing component (e.g., a microphone or keyboard) that records one or more requests of the patient.
- the patient enters one or more proposed “level of treatments” (e.g., levels of microcoring treatments), and system 10 provides a simulation of the effect of the various levels.
- system 10 e.g., via algorithm 25, for example an AI algorithm
- system 10 is configured to record information provided by a clinician (e.g., from a clinician via a clinician device 400), clinician provided data CPD or data CPD herein.
- Data CPD can comprise patient data PD, clinician data CD, vendor data VD, and/or other information that is provided by the clinician.
- Clinician device 400 can include one or more data recording components, such as a user interface 450 comprising one or more data recording components.
- user interface 450 can comprise a camera, a microphone, a keyboard, a touchscreen, a mouse, a joystick, and/or other user input component configured to record (e.g., and store in memory) data from a clinician and/or a clinician’s assistant (e.g., a nurse or other assistant, “clinician” herein).
- system 10 is configured to record information provided by a vendor (e.g., from a vendor via a vendor device 700), vendor provided data VPD or data VPD herein.
- Data VPD can comprise patient data PD, clinician data CD, vendor data VD, and/or other information that is provided by the vendor.
- Vendor device 700 can include one or more data recording components, such as a user interface 750 comprising one or more data recording components.
- user interface 750 can comprise a camera, a microphone, a keyboard, a touchscreen, a mouse, a joystick, and/or other user input component configured to record (e.g., and store in memory) data from a vendor.
- system 10 is configured to provide information, system provided data SPD or data SPD herein.
- Data SPD can be provided to a patient (e.g., via a patient device 300), to a clinician (e.g., via a clinician device 400), and/or to a vendor (e.g., Docket No. CYT-014-PCT via a vendor device 700).
- Data SPD can be customized (e.g., customized by algorithm 25, for example an AI algorithm), based on one or more patient parameters selected from the group consisting of: patient vicinity data PVD (e.g., a current or planned future location of the patient, and/or the location of the patient’s home and/or office); patient age, race, and/or other patient demographic data; history and physical exam data (H&P data); location of a clinician (e.g., location of a clinician in the general proximity to the current location of the patient or the patient’s home or office); location of a drug store (e.g., location of a drug store in the general proximity to the current location of the patient or the patient’s home or office); and combinations of these.
- patient vicinity data PVD e.g., a current or planned future location of the patient, and/or the location of the patient’s home and/or office
- patient age, race, and/or other patient demographic data e.g., history and physical exam data (H&P data)
- Data SPD provided to the patient by device 300 can comprise educational information, such as information intended to educate the patient about system 10, such as information related to microcoring and/or other procedures performed using system 10 (e.g., procedures performed by a clinician and/or other operator using treatment device 100).
- Data SPD provided to the patient by device 300 can comprise information related to one or more clinicians or other operators of system 10 (e.g., information related to clinicians in the local vicinity to the current location of the patient and/or the location of the patient’s home or office).
- Data SPD provided to the patient by device 300 can comprise information related to an appointment the patient has or can have with a clinician, such as an appointment related to a previous or future microcoring procedure performed using treatment device 100.
- Data SPD can be provided to assist the patient in scheduling an appointment with a clinician.
- Data SPD provided to the patient by device 300 can comprise information related to one or more suggested tasks for a patient to perform, such as a task to be performed prior to a microcoring treatment performed using treatment device 100 (e.g., take a medication, apply a topical substance, avoid the sun or put on sunscreen, and/or perform another task) and/or a task to be performed after microcoring treatment using treatment device 100 (e.g., take a medication, apply a topical substance, avoid the sun or put on sunscreen, and/or perform another task).
- a task to be performed prior to a microcoring treatment performed using treatment device 100 e.g., take a medication, apply a topical substance, avoid the sun or put on sunscreen, and/or perform another task
- a task to be performed after microcoring treatment using treatment device 100 e.g., take a medication, apply a topical substance, avoid the sun or put on sunscreen, and/or perform another task.
- System 10 can be configured to transmit data to a receiving component of system 10 (e.g., treatment device 100, patient device 300, clinician device 400, and/or vendor device 700 configured to receive data).
- a receiving component of system 10 e.g., treatment device 100, patient device 300, clinician device 400, and/or vendor device 700 configured to receive data.
- system 10 can be configured to receive data from a transmitting component of system 10 (e.g., treatment device 100, patient device 300, clinician device 400, and/or vendor device 700 configured to transmit data).
- system 10 is configured to provide treatment data TD (e.g., information related to one or more microcoring treatments performed using treatment device 100) to a patient, a clinician, and/or a vendor (e.g., via patient device 300. clinician device 400, and/or vendor device 700, respectively).
- Data TD can include treatment date, treatment time, system 10 settings of a microcoring or other treatment, and/or other treatment information.
- Data TD can include information recorded via a QR code of a treatment device 100 (e.g., a QR code scanned by a functional element of treatment device 100 and/or console 500 comprising a camera).
- Treatment information can comprise one or more images of the patient (e.g., one or more photographs of a skin portion of the patient that is to be treated and/or has already been treated using treatment device 100).
- algorithm 25 e.g., an AI algorithm
- algorithm 25 is configured to analyze data TD (e.g., one or more images of the patient) to determine microcoring treatment settings and/or post-microcoring treatment settings.
- Data TD can provide a record (e.g., a validation) that a microcoring or other procedure performed using system 10 was performed, for example the record including the location, time, and/or date.
- the record can correlate this data with system 10 settings used in a microcoring procedure, and/or with post-procedural result data (e.g., post procedural images and/or other efficacy information).
- Operator (e.g., clinician operator) technique quality can be recorded by system 10 via inertial measurement units (IMUs), such as to identify one or more of: treatment device 100 movement relative to anatomy; smoothness of treatment device 100 movement; and/or detection of treatment device 100 treating the same location.
- IMUs inertial measurement units
- functional element 199 of treatment device 100 can comprise one or more accelerometers and/or other sensors configured to produce motion and/or position data of device 100.
- System 10 can be configured to: collect movement, position, and/or other data across multiple operators of system 10; calculate population analytics to determine and identify operators that achieve and/or are likely to achieve optimized outcomes; and/or compare operator technique data of multiple operators such as to compare operators (e.g., and provide feedback to one or more operators).
- System 10 can be configured to allow a user to upload and/or download various information stored by one or more components of system 10.
- patient information PI, clinician information CI, and/or treatment information data TD can be transferred between (e.g., uploaded from and/or downloaded to) server 20, treatment device 100, patient device 300, clinician device 400, console 500, and/or vendor device 700.
- a clinician transfers information to a clinician device 400.
- information is uploaded to a “cosmetic community” web hosting site.
- system 10 is configured to share collected information (e.g., treatment data TD, patient data PD, and/or other data collected by system 10) with one or more of: clinicians, patients, a parent of a patient, and/or an information “portal”.
- system 10 is configured to set up (i.e., create) one or more of: a community event; a training workshop such as an online training workshop; a consult, such as a virtual (e.g., web meeting) consult; and/or a virtual (e.g., web meeting) event.
- a community event e.g., a training workshop such as an online training workshop
- a consult such as a virtual (e.g., web meeting) consult
- a virtual (e.g., web meeting) event e.g., web meeting) event.
- System 10 can be configured to provide suggestions for post-microcoring care of a patient (e.g., to be performed by a patient and/or their clinician).
- system 10 provides advertisements to a patient, a clinician, and/or a vendor, such as advertisements related to products (e.g., skin modification device 900 described herein) to be used in the post-microcoring care (e.g., products that enhance healing and/or the cosmetic improvements of the microcoring procedure).
- system 10 is configured to provide post-microcoring care reminders, such as temporal reminders suggesting the use of one or more products (e.g., skin modification device 900 described herein) at particular times (e.g., to be performed on particular days after the performance of the microcoring procedure).
- skin modification device 900 can comprise a product configured to deliver an agent selected from the group consisting of: hyaluronic acid; a moisturizer; an analgesic; a peptide; exosomes; platelet-rich plasma (PRP); arnica montana extract; a vasoconstrictor; methotrexate; minoxidil; stem cells; botulinum toxin; a corticosteroid; and combinations of these.
- an agent selected from the group consisting of: hyaluronic acid; a moisturizer; an analgesic; a peptide; exosomes; platelet-rich plasma (PRP); arnica montana extract; a vasoconstrictor; methotrexate; minoxidil; stem cells; botulinum toxin; a corticosteroid; and combinations of these.
- system 10 (e.g., via algorithm 25, for example an AI algorithm) is configured to define a profile of a user (e.g., a patient, clinician, and/or vendor) and/or make suggestions to that user based on a parameter of that user, such as a parameter selected from the group consisting of: buying habits; interests; opportunity to sell to other product or service providers interested in this demographic; and combinations of these.
- system 10 is configured to offer for sale post-operative care, such as post-operative care offered via an online marketplace.
- system 10 (e.g., the manufacturer of system 10) can serve as a “broker” between vendors, clinicians, Docket No.
- System 10 can be configured to provide a “discount” (e.g., a reduction in a standard amount of payment for a good or service), such as a discount provided to a patient, a clinician, and/or a vendor.
- a “discount” e.g., a reduction in a standard amount of payment for a good or service
- system 10 can be configured to provide a “refer a friend” function.
- a discount to a system 10 product and/or a service provided by system 10 can be provided to a user based on the referring of another potential user.
- system 10 is configured to provide a discount if an appointment is established within a pre-determined timeframe (e.g., receive a discount “if you book today”).
- system 10 is configured to receive a payment, such as a payment made by a patient, a clinician, and/or a vendor.
- system 10 is configured to process a payment (e.g., a refund, payment for services, and/or other payment) to a clinician, a vendor, and/or a patient.
- system 10 is configured to receive a payment (e.g., a commission) from a vendor, such as a commission based on a product of that vendor that is sold because of and/or related to a microcoring procedure performed using system 10.
- a payment e.g., a commission
- System 10 can be configured to provide an interface to a social media platform (e.g., X, Instagram, and the like).
- a social media platform e.g., X, Instagram, and the like.
- system 10 can be configured such that a patient, clinician, and/or vendor, using a device 300, 400, and/or 700, respectively, can transfer information from and/or to a social media platform.
- a patient and/or other user of system 10 can transfer particular patient data PD to a social media platform (also referred to as “posting”).
- a patient or other user can receive information from a social media platform.
- system 10 e.g. algorithm 25, for example an AI algorithm
- system 10 is configured to search one, two, or more social media platforms, and identify other patients that have received a microcoring procedure (other patients that have been treated using system 10), such as to allow a patient (e.g. a potential or future patient) the opportunity to gain information and/or connect with (e.g., “friend”) the one or more other patients.
- System 10 can be configured to allow a user (e.g., a patient and/or a clinician) to provide a review of another user (e.g., a clinician and/or a vendor) and/or a user’s product (e.g., a product of a clinician and/or a vendor).
- a patient can provide a review (e.g., a quantitative and/or qualitative assessment) of a clinician (and/or the office staff of that clinician) that performed a microcoring procedure on that patient, and/or an assessment of a Docket No. CYT-014-PCT product obtained from a clinician and/or a vendor.
- System 10 (e.g., via algorithm 25, for example an AI algorithm) can be configured to perform population analytics, such as to identify similar patients and/or clinician profiles, such as for sharing with (e.g., distribution to) one or more potential patients and/or clinicians.
- System 10 can be configured to allow a device 300/400/700 to download information from one or more treatment devices 100, agent delivery assemblies 200, and/or consoles 500. The information can be downloaded via a wired and/or wireless connection provided by network 80.
- a clinician device 400 can download information related to a microcoring procedure performed using a treatment device 100 on a particular patient of the clinician, such as to maintain a treatment log for that patient.
- a clinician device 400 can be configured to receive summary data reports for one or more (e.g., all) patients of the clinician(s) associated with that particular clinician device 400.
- treatment logs of multiple patients of a clinician are compared by system 10 (e.g., via algorithm 25, for example an AI algorithm), such as to identify discrepancies, trends, and/or other comparative information.
- treatment logs of multiple patients of two or more clinicians are compared by system 10 (e.g., via algorithm 25, for example an AI algorithm), such as to identify discrepancies, trends, and/or other comparative information (e.g., differences between patients, between clinicians, or both).
- System 10 can be configured to allow a clinician and/or a vendor, via clinician device 400 and/or vendor device 700, to create advertising materials, such as advertising materials that are transmitted to patient device 300, server 20, and/or network 80 (e.g., the Internet).
- advertising materials such as advertising materials that are transmitted to patient device 300, server 20, and/or network 80 (e.g., the Internet).
- clinician and/or vendor advertising can be posted on one or more patient device 300 (e.g., on each applicable patient device 300), on broadcast media (e.g., television or radio), and/or on a website (e.g., a website of the clinician, vendor, and/or manufacturer of system 10).
- system 10 is configured to provide information (e.g., curated references) regarding patients who are identified by system 10 as potential candidates for a microcoring and/or other procedure to be performed using system 10, such as when that patient is predicted by system 10 to achieve optimized or at least reasonable outcomes from the system 10 procedure.
- system 10 is configured to provide a “link” between a patient and one or more clinicians, such as a link in which certain communications with the patient and/or the clinician are also sent to the other party.
- creation of the link may require confirmation that the link is acceptable, such as confirmation required of the patient, the clinician, or both.
- system 10 is configured to provide instructions and/or reminders to a patient regarding pre-procedural tasks (e.g., tasks to be performed prior to a microcoring procedure), such as to reduce time in a clinical setting (e.g., clinician’s office) for the patient when receiving a microcoring procedure.
- pre-procedural tasks e.g., tasks to be performed prior to a microcoring procedure
- system 10 is configured to allow a patient (e.g., a prospective patient) to enter a “desired procedure” into system 10.
- algorithm 25 e.g., an AI algorithm
- algorithm 25 can be configured to provide feedback to the patient (e.g., via device 300), such as feedback comprising: one or more system 10 created images of the patient (e.g., the patient’s face or other treatment area) approximating the appearance of the patient after the desired procedure is performed; an assessment of the appropriateness of the desired procedure for the patient; one or more alternative suggested procedures (e.g., determined to be more appropriate by system 10 than the desired procedure); and combinations of these.
- feedback comprising: one or more system 10 created images of the patient (e.g., the patient’s face or other treatment area) approximating the appearance of the patient after the desired procedure is performed; an assessment of the appropriateness of the desired procedure for the patient; one or more alternative suggested procedures (e.g., determined to be more appropriate by system 10 than the desired procedure); and combinations of these.
- system 10 can be configured to produce a three-dimensional (3D) “selfie” (i.e., image of the patient’s face or other body portion) representing the current condition of the patient (e.g., using patient images provided by the patient or otherwise) and/or representing a predicted outcome of a microcoring and/or other procedure performed on that patient using system 10.
- the 3D selfie can be produced either via stitching multiple two-dimensional (2D) images and/or using augmented reality.
- system 10 such as via algorithm 25 (e.g., an AI algorithm), is configured to create a set of system-created patient images, “predicted images” or “predicted patient images”, that represent simulated outcomes of one or more microcoring procedures to potentially be performed on a patient.
- algorithm 25 e.g., an AI algorithm
- system 10 is configured to create a set of system-created patient images, “predicted images” or “predicted patient images”, that represent simulated outcomes of one or more microcoring procedures to potentially be performed on a patient.
- algorithm 25 e.g., an AI algorithm
- a clinician can iteratively change the microcoring settings, such as to determine an optimized set of these settings based on the algorithm- created images (e.g., to enhance and/or predict patient satisfaction that results from the performance of the subsequent microcoring procedure).
- system 10 such as via algorithm 25 (e.g., an AI algorithm), is configured to suggest a type of clinician, and/or suggest a particular clinician to a patient.
- algorithm 25 can analyze patient data PD (e.g., data PD comprising: patient images; patient desired outcomes data; patient physiologic data; patient location data; Docket No.
- system 10 is configured to perform population analytics to determine which clinician of a set of multiple clinicians has treated the highest quantity of similar profile patients. [311] In some embodiments, system 10 is configured to create and/or provide advertising of a promotional event or other event associated with the use of system 10.
- system 10 can be configured to send a group email, provide information to a social media platform, and/or provide information to a device 300/400/700.
- system 10 is configured to organize and/or otherwise cause to occur: one or more virtual events; one or more live events; or both.
- system 10 is configured to “harvest data” (e.g., gather data from one or more system 10 components), such as to process, analyze, log, disseminate, and/or sell the harvested data and/or an analysis of the harvested data.
- algorithm 25 e.g., an AI algorithm
- system 10 can be configured to sell data (e.g., non HIPAA data) to third parties (e.g., vendors associated with system 10 as described herein and/or other parties).
- system 10 is configured to sell the data to vendors that sell cosmetic products or other products associated with a treatment performed using system 10 (e.g., products used as part of post-microcoring treatment care).
- system 10 is configured to sell data to vendors who sell products to similar customers (e.g., customers of similar income levels and/or customers who are associated with seeking improvements in their physical appearance).
- system 10 is configured to harvest data to perform a registry study, such as to reduce the cost of the registry study.
- system 10 can be configured to reduce the complexity of the patient-consenting process, such as to support and/or enhance enrolling of patients from multiple clinical practices into a multiple- site study.
- system 10 is configured to provide other collaborative clinical study tools, such as to provide an automated creation of documents for submittal to an internal review board (e.g., of a hospital or other clinical setting).
- system 10 is configured to upload IOT data (“internet of things” data), such as IOT data uploaded by one or more components of system 10. In some Docket No.
- algorithm 25 e.g., an AI algorithm
- algorithm 25 is configured to identify the IOT data to be uploaded, perform an analysis on the IOT data that is uploaded, or both.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Measuring And Recording Apparatus For Diagnosis (AREA)
Abstract
A system for performing a cosmetic procedure on multiple patients is provided. The system includes at least one microcoring subsystem. Each microcoring subsystem includes at least one treatment device. Each treatment device includes a set of multiple treatment modules and at least one actuation assembly. Each treatment module includes one or more coring elements. Each actuation assembly operably attaches to a treatment module to perform a microcoring procedure. The microcoring procedure includes the treatment module translating in a series of reciprocating motions, each reciprocating motion includes each coring element being inserted into and withdrawn from tissue of a patient.
Description
Docket No. CYT-014-PCT SKIN TREATMENT SYSTEMS, DEVICES, AND METHODS RELATED APPLICATIONS [001] This application claims the benefit of United States Provisional Patent Application Serial Number 63/604,378 (Docket No.: CYT-014-PR1), titled "Skin Treatment Systems, Devices and Methods", filed November 30, 2023, the content of which is incorporated herein by reference in its entirety for all purposes. [002] This application claims the benefit of United States Provisional Patent Application Serial Number 63/666,978 (Docket No.: CYT-016-PR1), titled "Skin Treatment Systems, Devices and Methods", filed July 2, 2024, the content of which is incorporated herein by reference in its entirety for all purposes. [003] This application is related to United States Provisional Patent Application Serial Number 61/766,937 (Docket No.: CYT-001-PR), titled "Methods and Devices for Skin Tightening", filed February 20, 2013, the content of which is incorporated herein by reference in its entirety for all purposes. [004] This application is related to International Patent Application Serial Number PCT/US2014/016483 (Docket No.: CYT-001-PCT), titled "Methods and Devices for Skin Tightening", filed February 14, 2014, Publication Number WO2014/130359, published August 28, 2014, the content of which is incorporated herein by reference in its entirety for all purposes. [005] This application is related to United States Patent Application Serial Number 14/764,866 (Docket No.: CYT-001-US), titled "Methods and Devices for Skin Tightening", filed July 30, 2015, United States Patent No.10,543,127, issued January 18, 2020, the content of which is incorporated herein by reference in its entirety for all purposes. [006] This application is related to United States Patent Application Serial Number 15/905,421 (Docket No.: CYT-001-US-CON1), titled "Methods and Devices for Skin Tightening", filed February 26, 2018, United States Patent No.10,251,792, issued April 9, 2019, the content of which is incorporated herein by reference in its entirety for all purposes. [007] This application is related to United States Patent Application Serial Number 16/707,122 (Docket No.: CYT-001-US-DIV), titled "Methods and Devices for Skin Tightening", filed December 9, 2019, United States Patent No.11,534,344, issued December
Docket No. CYT-014-PCT 27, 2022, the content of which is incorporated herein by reference in its entirety for all purposes. [008] This application is related to United States Patent Application Serial Number 17/987,190 (Docket No.: CYT-001-US-DIV-CON1), titled Methods and Devices for Skin Tightening”, filed November 15, 2022, United States Patent No.12,023,226, issued July 2, 2024, the content of which is incorporated herein by reference in its entirety for all purposes. [009] This application is related to United States Patent Application Serial Number 18/655,705 (Docket No.: CYT-001-US-DIV-CON2), titled Methods and Devices for Skin Tightening”, filed May 6, 2024, United States Publication Number __________, published ____________, the content of which is incorporated herein by reference in its entirety for all purposes. [010] This application is related to United States Provisional Patent Application Serial Number 61/819,190 (Docket No.: CYT-002-PR), titled "Microclosures and Related Methods for Skin Treatment", filed May 3, 2013, the content of which is incorporated herein by reference in its entirety for all purposes. [011] This application is related to International Application Serial Number PCT/US14/036638 (Docket No.: CYT-002-PCT), titled "Microclosures and Related Methods for Skin Treatment", filed May 2, 2014, Publication No. WO2014/0179729, published November 6, 2014, the content of which is incorporated herein by reference in its entirety for all purposes. [012] This application is related to United States Patent Application Serial Number 14/786,328 (Docket No.: CYT-002-US), titled "Microclosures and Related Methods for Skin Treatment", filed October 22, 2015, United States Publication No.2016/0095592, published April 7, 2016, the content of which is incorporated herein by reference in its entirety for all purposes. [013] This application is related to United States Patent Application Serial Number 17/207,172 (Docket No.: CYT-002-US-CON), titled "Microclosures and Related Methods for Skin Treatment", filed March 19, 2021, United States Publication No.2021/0322005, published October 21, 2021, the content of which is incorporated herein by reference in its entirety for all purposes. [014] This application is related to United States Provisional Patent Application Serial Number 61/864,281 (Docket No.: CYT-003-PR), titled "Methods and Apparatuses for Skin
Docket No. CYT-014-PCT Treatment using Non-Thermal Tissue Ablation", filed March August 9, 2013, the content of which is incorporated herein by reference in its entirety for all purposes. [015] This application is related to International Application Serial Number PCT/US14/050426 (Docket No.: CYT-003-PCT), titled "Methods and Apparatuses for Skin Treatment using Non-Thermal Tissue Ablation", filed August 8, 2014, Publication No. WO2015/021434, published February 12, 2015, the content of which is incorporated herein by reference in its entirety for all purposes. [016] This application is related to United States Patent Application Serial Number 14/910,767 (Docket No.: CYT-003-US), titled “Methods and Apparatuses for Skin Treatment using Non-Thermal Tissue Ablation”, filed February 8, 2016, United States Patent No. 10,555,754, issued February 11, 2020, the content of which is incorporated herein by reference in its entirety for all purposes. [017] This application is related to United States Patent Application Serial Number 16/722,069 (Docket No.: CYT-003-US-DIV), titled “Methods and Apparatuses for Skin Treatment using Non-Thermal Tissue Ablation”, filed December 20, 2019, United States Patent No.12,150,671, issued November 26, 2024, the content of which is incorporated herein by reference in its entirety for all purposes. [018] This application is related to United States Patent Application Serial Number 18/921,404 (Docket No.: CYT-003-US-DIV-CON), titled “Methods and Apparatuses for Skin Treatment using Non-Thermal Tissue Ablation”, filed October 21, 2024, United States Publication No. _______________, published _______________, the content of which is incorporated herein by reference in its entirety for all purposes. [019] This application is related to United States Provisional Patent Application Serial Number 61/918,271 (Docket No.: CYT-004-PR), titled "Methods and Devices for Manipulating Subdermal Fat", filed March December 19, 2013, the content of which is incorporated herein by reference in its entirety for all purposes. [020] This application is related to International Application Serial Number PCT/US14/071443 (Docket No.: CYT-004-PCT), titled "Methods and Devices for Manipulating Subdermal Fat", filed December 19, 2014, Publication No. WO2015/095675, published June 25, 2015, the content of which is incorporated herein by reference in its entirety for all purposes. [021] This application is related to United States Patent Application Serial Number 15/106,036 (Docket No.: CYT-004-US), titled "Methods and Devices for Manipulating
Docket No. CYT-014-PCT Subdermal Fat", filed June 17, 2016, United States Patent No.10,953,143, issued March 23, 2021, the content of which is incorporated herein by reference in its entirety for all purposes. [022] This application is related to United States Patent Application Serial Number 17/166,543 (Docket No.: CYT-004-US-DIV), titled "Methods and Devices for Manipulating Subdermal Fat", filed February 3, 2021, United States Publication No.2021/0178028, published June 17, 2021, the content of which is incorporated herein by reference in its entirety for all purposes. [023] This application is related to United States Provisional Patent Application Serial Number 62/079,822 (Docket No.: CYT-005-PR), titled "Devices and Methods for Ablation of the Skin", filed March November 14, 2014, the content of which is incorporated herein by reference in its entirety for all purposes. [024] This application is related to International Application Serial Number PCT/US15/060685 (Docket No.: CYT-005-PCT), titled "Devices and Methods for Ablation of the Skin", filed November 13, 2015, Publication No. WO2016/077759, published May 19, 2016, the content of which is incorporated herein by reference in its entirety for all purposes. [025] This application is related to United States Patent Application Serial Number 15/526,299 (Docket No.: CYT-005-US), titled "Devices and Methods for Ablation of the Skin", filed May 11, 2017, United States Patent No.11,324,534, issued May 10, 2022, the content of which is incorporated herein by reference in its entirety for all purposes. [026] This application is related to United States Patent Application Serial Number 17/709,542 (Docket No.: CYT-005-US-CON1), titled "Devices and Methods for Ablation of the Skin", filed March 31, 2022, United States Patent No.11,896,261, issued February 13, 2024, the content of which is incorporated herein by reference in its entirety for all purposes. [027] This application is related to United States Patent Application Serial Number 18/405,315 (Docket No.: CYT-005-US-CON2), titled "Devices and Methods for Ablation of the Skin", filed January 5, 2024, United States Publication No. ___________, published ______________, the content of which is incorporated herein by reference in its entirety for all purposes. [028] This application is related to United States Design Patent Application Serial Number 29/509,219 (Docket No.: CYT-006-DES), titled "Device and Device Body for Mechanical Fractional Ablation of the Skin", filed November 14, 2014, United States Design
Docket No. CYT-014-PCT Patent No. D797286, issued September 12, 2017, the content of which is incorporated herein by reference in its entirety for all purposes. [029] This application is related to United States Provisional Patent Application Serial Number 62/314,748 (Docket No.: CYT-007-PR), titled "Devices and Methods for Cosmetic Skin Resurfacing", filed March 29, 2016, the content of which is incorporated herein by reference in its entirety for all purposes. [030] This application is related to International Application Serial Number PCT/US17/024752 (Docket No.: CYT-007-PCT), titled "Devices and Methods for Cosmetic Skin Resurfacing", filed March 29, 2017, Publication No. WO2017/0172920, published October 5, 2017, the content of which is incorporated herein by reference in its entirety for all purposes. [031] This application is related to United States Patent Application Serial Number 16/090,034 (Docket No.: CYT-007-US), titled "Devices and Methods for Cosmetic Skin Resurfacing", filed September 28, 2018, United States Patent No.11,166,743, issued November 9, 2021, the content of which is incorporated herein by reference in its entirety for all purposes. [032] This application is related to United States Patent Application Serial Number 17/491,691 (Docket No.: CYT-007-US-CON1), titled “Devices and Methods for Cosmetic Skin Resurfacing”, filed October 1, 2021, United States Publication No.2022-0125477, published April 28, 2022, the content of which is incorporated herein by reference in its entirety for all purposes. [033] This application is related to United States Provisional Patent Application Serial Number 62/397,869 (Docket No.: CYT-008-PR), titled “Devices and Methods for Cosmetic Skin Resurfacing”, filed September 21, 2016, the content of which is incorporated herein by reference in its entirety for all purposes. [034] This application is related to International Patent Application Serial Number PCT/US17/052528 (Docket No.: CYT-008-PCT), titled “Devices and Methods for Cosmetic Skin Resurfacing”, filed September 20, 2017, Publication No.2018/057630, published March 29, 2018, the content of which is incorporated herein by reference in its entirety for all purposes. [035] This application is related to United States Patent Application Serial Number 16/335,028 (Docket No.: CYT-008-US), titled "Devices and Methods for Cosmetic Skin
Docket No. CYT-014-PCT Resurfacing", filed March 20, 2019, United States Patent No.11,464,954, issued October 11, 2022, the content of which is incorporated herein by reference in its entirety for all purposes. [036] This application is related to United States Patent Application Serial Number 17/902,028 (Docket No.: CYT-008-US-CON1), titled " Devices and Methods for Cosmetic Skin Resurfacing", filed September 2, 2022, United States Publication No.2023/0210552, published July 6, 2023, the content of which is incorporated herein by reference in its entirety for all purposes. [037] This application is related to United States Provisional Patent Application Serial Number 62/397,865 (Docket No.: CYT-009-PR), titled "Rapid Skin Treatment Using Microcoring", filed September 21, 2016, the content of which is incorporated herein by reference in its entirety for all purposes. [038] This application is related to International Patent Application Serial Number PCT/US17/052539 (Docket No.: CYT-009-PCT), titled "Rapid Skin Treatment Using Microcoring", filed September 20, 2017, Publication No.2018/057637, published March 29, 2018, the content of which is incorporated herein by reference in its entirety for all purposes. [039] This application is related to United States Patent Application Serial Number 15/711,943 (Docket No.: CYT-009-US), titled "Rapid Skin Treatment Using Microcoring", filed September 21, 2017, United States Publication No.2018/0078278, published March 22, 2018, the content of which is incorporated herein by reference in its entirety for all purposes. [040] This application is related to United States Patent Application Serial Number 16/857,801 (Docket No.: CYT-009-US-CON1), titled "Rapid Skin Treatment Using Microcoring", filed April 24, 2020, United States Publication No.2020/0246039, published August 6, 2020, the content of which is incorporated herein by reference in its entirety for all purposes. [041] This application is related to United States Provisional Patent Application Serial Number 62/756,694 (Docket No.: CYT-010-PR), titled "Systems and Methods for Skin Treatment", filed November 7, 2018, the content of which is incorporated herein by reference in its entirety for all purposes. [042] This application is related to International Patent Application Serial Number PCT/US19/060131 (Docket No.: CYT-010-PCT), titled "Systems and Methods for Skin Treatment", filed November 6, 2019, Publication No.2020/097244, published May 14, 2020, the content of which is incorporated herein by reference in its entirety for all purposes.
Docket No. CYT-014-PCT [043] This application is related to United States Patent Application Serial Number 17/291,235 (Docket No.: CYT-010-US), titled "Systems and Methods for Skin Treatment", May 4, 2021, United States Publication No.2021/0401453, published December 30, 2021, the content of which is incorporated herein by reference in its entirety for all purposes. [044] This application is related to United States Provisional Patent Application Serial Number 63/190,904 (Docket No.: CYT-012-PR1), titled "Skin Treatment Systems and Methods", filed May 20, 2021, the content of which is incorporated herein by reference in its entirety for all purposes. [045] This application is related to International Patent Application Serial Number PCT/US22/030236 (Docket No.: CYT-012-PCT), titled “Skin Treatment Systems and Methods”, filed May 20, 2022, Publication No.2022/0246185, published November 24, 2022, the content of which is incorporated herein by reference in its entirety for all purposes. [046] This application is related to United States Patent Application Serial Number 18/560,784 (Docket No.: CYT-012-US), titled "Systems and Methods for Skin Treatment", November 14, 2023, United States Publication No.2024/0252200, published August 1, 2024, the content of which is incorporated herein by reference in its entirety for all purposes. [047] This application is related to United States Provisional Patent Application Serial Number 63/248,562 (Docket No.: CYT-013-PR1), titled “Skin Treatment Systems, Devices and Methods”, filed September 27, 2021, the content of which is incorporated herein by reference in its entirety for all purposes. [048] This application is related to International Patent Application Serial Number PCT/US22/044862 (Docket No.: CYT-013-PCT), titled “Skin Treatment Systems and Methods”, filed September 27, 2022, Publication No.2023/0049500, published June 8, 2023, the content of which is incorporated herein by reference in its entirety for all purposes. [049] This application is related to United States Patent Application Serial Number 18/695,869 (Docket No.: CYT-013-US), titled "Systems and Methods for Skin Treatment", filed March 27, 2024, United States Publication No. ____________, published ________________, the content of which is incorporated herein by reference in its entirety for all purposes. [050] This application is related to United States Provisional Patent Application Serial Number 63/546,808 (Docket No.: CYT-015-PR1), titled "Skin Treatment Systems, Devices
Docket No. CYT-014-PCT and Methods", filed November 1, 2023, the content of which is incorporated herein by reference in its entirety for all purposes. [051] This application is related to United States Provisional Patent Application Serial Number 63/555,134 (Docket No.: CYT-015-PR2), titled "Skin Treatment Systems, Devices and Methods", filed February 19, 2024, the content of which is incorporated herein by reference in its entirety for all purposes. [052] This application is related to International Patent Application Serial Number PCT/US24/054100 (Docket No.: CYT-015-PCT), titled “Skin Treatment Systems, Devices, and Methods”, filed November 1, 2024, Publication No. ________________, published ___________________, the content of which is incorporated herein by reference in its entirety for all purposes. FIELD OF INVENTIVE CONCEPTS [053] The embodiments disclosed herein relate generally to systems, devices, and methods for treatment of biological tissues. BACKGROUND [054] Many human health and other issues arise from damage, deterioration, or loss of tissue due to disease, advanced age, and/or injury. These issues can manifest themselves in a variety of alterations of tissue structure and/or function, including scarring, sclerosis, tightness, and laxity. In aesthetic medicine, elimination of excess tissue and/or skin laxity is an important concern that affects more than 25% of the U.S. population. SUMMARY [055] There is a need for improved systems and methods that provide increased effectiveness over currently available techniques while maintaining convenience, affordability, and accessibility to individuals desiring tissue restoration. [056] According to an aspect of the present inventive concepts, a system for performing a cosmetic procedure on multiple patients comprises at least one microcoring subsystem. Each microcoring subsystem comprising at least one treatment device. Each treatment device comprising a set of multiple treatment modules. Each treatment module comprising one or more coring elements. The system further comprises at least one actuation assembly configured to operably attach to a treatment module and configured to perform a microcoring
Docket No. CYT-014-PCT procedure comprising the treatment module translating in a series of reciprocating motions. Each reciprocating motion comprises each coring element being inserted into and withdrawn from tissue of a patient. [057] In some embodiments, the at least one microcoring subsystem comprises a first microcoring subsystem located at a first clinical location and a second microcoring subsystem located at a second clinical location different than the first clinical location. The first microcoring subsystem can comprise a first set of devices comprising multiple patient devices, multiple clinician devices, and/or multiple vendor devices in communication with the first microcoring subsystem and the second microcoring subsystem can comprise a second set of devices comprising multiple patient devices, multiple clinician devices, and/or multiple vendor devices in communication with the second microcoring subsystem. [058] In some embodiments, the at least one treatment device comprises two or more treatment devices. [059] In some embodiments, the system further comprises a network and/or a server, and the network and/or server is configured to receive data from each microcoring subsystem of the at least one microcoring subsystem. [060] In some embodiments, the system further comprises: at least one patient device; at least one clinician device; and/or at least one vendor device. [061] In some embodiments, each microcoring subsystem of the at least one microcoring subsystem comprises one, two, or more components selected from the group consisting of: at least one console; at least one imaging device; at least one implant; at least one tissue collection assembly; and combinations thereof. [062] In some embodiments, the microcoring procedure is configured to provide a cosmetic effect to the patient. [063] In some embodiments, the series of reciprocating motions comprises at least one reciprocating motion. The series of reciprocating motions can comprise at least two reciprocating motions. [064] In some embodiments, the actuation assembly is further configured to translate the treatment module in one or more directions relative to a surface of skin tissue of the patient. [065] In some embodiments, the system is configured to perform the series of reciprocating motions based on one, two, or more reciprocating motion parameters. [066] In some embodiments, the system further comprises a patient device that includes a patient app. The patient device can comprise one, two, or more devices selected from the group consisting of: phone; cell phone; smart phone; computer; laptop computer; tablet
Docket No. CYT-014-PCT computer; automobile communication device; a patient-monitoring device; and combinations thereof. The patient device can comprise at least one patient-monitoring device. The at least one patient-monitoring device can comprise one, two, or more devices selected from the group consisting of: camera or camera system; exercise monitoring device; sleep monitoring device; sleep apnea monitoring device; EKG and/or other heart monitoring device; EEG and/or other brain monitoring device; blood pressure monitoring device; blood glucose- monitoring device; other health-monitoring device; a patient location device; and combinations thereof. The patient device can be configured for multiple modes of operation. The multiple modes of operation can comprise different levels of complexity. The multiple modes of operation can comprise different levels of involvement of two or more of the multiple patients. The multiple modes of operation can comprise a parent-guardian mode of operation. The patient device can be configured to provide information to a patient. The system can be configured to receive patient parameter data and the information provided to the patient is customized based on the patient parameter data. The patient parameter data can comprise patient location data. The patient parameter data can comprise: patient image data; patient lifestyle data; patient medical history data; age data; race data; sex data; weight data; body mass index data; skin quality and/or other skin characterization data; patient health data; patient allergy data; data related to a previous microcoring procedure; data related to a previous surgical and/or other clinical procedure; DNA and/or other genetic data; data related to medications taken by the patient; patient diet data; patient location data; patient travel data; patient occupation data; and/or patient financial data. The patient parameter data can comprise data related to one or more clinicians in relative proximity to the home or other associated location of the patient. The patient parameter data can comprise data related to one or more drug stores in relative proximity to the home or other associated location of the patient. The information provided to the patient can comprise microcoring procedure education information. The information provided to the patient can comprise post- microcoring procedure information. The information provided to the patient can comprise information related to applying sunscreen or other topical agent, taking a medication, or both. The information provided to the patient can comprise information related to a future appointment of the patient with a clinician. The patient device can be configured to record patient data. The patient data recorded can comprise: age data; race data; sex data; weight data; body mass index data; skin quality and/or other skin characterization data; patient health data; patient allergy data; data related to a previous microcoring procedure; data related to a previous surgical and/or other clinical procedure; DNA and/or other genetic data; data related
Docket No. CYT-014-PCT to medications taken by the patient; patient diet data; patient location data; patient travel data; patient occupation data; and/or patient financial data. The system can be configured to accept the patient data from multiple data sources. The patient data can comprise data collected after the performance of a microcoring procedure. The system can be configured to provide the patient data to a clinician of the patient. The system can be configured to provide the patient data to a cosmetic community. The patient device can be configured to provide a “refer-a-friend” function. The system can be configured to provide a patient with a discount for each future patient recommended by the patient. The patient device can be configured to provide a patient interface to one or more social media platforms. [067] In some embodiments, the system further comprises a clinician device that includes a clinician app. The clinician device can comprise one, two, or more devices selected from the group consisting of: phone; cell phone; smart phone; computer; laptop computer; tablet computer; automobile communication device; a patient-monitoring device; and combinations thereof. The clinician device can be configured for multiple modes of operation. The clinician device can be configured to be used by multiple clinicians, and a first mode of operation can be configured for use by a first clinician and a second mode of operation can be configured for use by a second clinician. The clinician device can be configured to provide a clinician advertising function. The clinician device can be configured to receive summary data reports. [068] In some embodiments, the system further comprises a vendor device that includes a vendor app. The vendor device can be configured to provide an advertising access function. [069] In some embodiments, the system further comprises a controller and a memory storage component coupled to the controller, and the memory storage component stores instructions for the controller to perform an algorithm, and the algorithm is configured to provide an algorithm output. The algorithm can comprise an artificial intelligence algorithm. The algorithm can provide the algorithm output based on images of a patient. The system can be configured to record patient data, clinician data, and/or vendor data, and the algorithm can provide the algorithm output based on one, two, or three of: patient data; clinician data; and/or vendor data. The system can be configured to record patient data, and the algorithm can provide the algorithm output based on patient data selected from the group consisting of: age data; race data; sex data; weight data; body mass index data; skin quality and/or other skin characterization data; patient health data; patient allergy data; data related to a previous microcoring procedure; data related to a previous surgical and/or other clinical procedure;
Docket No. CYT-014-PCT DNA and/or other genetic data; data related to medications taken by the patient; patient diet data; patient location data; patient travel data; patient occupation data; patient financial data; and combinations thereof. The algorithm can be adjustable. The algorithm can be configured to be adjusted by a clinician. The system can be configured to record patient data, and the algorithm can be configured to manipulate and/or otherwise analyze the patient data and predict a potential outcome of the microcoring procedure. The patient data can comprise patient data recorded from a camera. The system can be configured to record patient data, and the algorithm can be configured to analyze the patient data and profile and/or identify one or more patients that are predicted to have a desired outcome of the microcoring procedure. The system can be configured to record patient data, and the algorithm can be configured to identify patients with similar demographic and/or clinical profiles. The system can be configured to share outcomes achieved by other patients with similar profiles. [070] In some embodiments, the system is configured to operate in a clinician link mode in which the system produces clinician-linked information, and the clinician-linked information is related to a particular clinician. The clinician-linked information output by the system can comprise data provided to a patient that is based on a clinician of the patient. The clinician-linked information output by the system can comprise patient data provided to a clinician of a patient, and the patient data can be provided prior to a microcoring procedure. [071] In some embodiments, the system is configured to allow a patient to enter the parameters of a desired microcoring procedure. The system can be further configured to provide an assessment of the applicability of the desired microcoring procedure. [072] In some embodiments, the system is configured to provide a predicted outcome of a proposed microcoring procedure on a patient. The predicted outcome can comprise predicted images of the patient that comprise estimations of the patient’s skin sometime after the microcoring procedure is performed. The predicted images can be based on patient provided images. [073] In some embodiments, the system is configured to provide a prediction of patient satisfaction that will result after the performance of a microcoring procedure. [074] In some embodiments, the system is configured to advertise a promotional event. The advertising can comprise advertising provided via a group email and/or information provided on a social medial platform. [075] In some embodiments, the system is configured to perform data harvesting related to data produced in one or more microcoring procedures performed by the system. The data harvesting can be configured to produce harvested data, and the system can be configured to
Docket No. CYT-014-PCT sell the harvested data. The system can be configured to sell the harvested data to vendors that sell cosmetic products. The system can be configured to sell the harvested data to vendors that have similar customers to the customers that buy the system. The similarity between the similar customers can be an income level of each customer. [076] In some embodiments, the system is configured to collect patient data and to perform and/or assist in the performance of a registry study. [077] In some embodiments, the system is configured to notify patients who have received a microcoring procedure performed using the system of an additional procedure that could be performed. The additional procedure can comprise an additional microcoring procedure performed using the system. The additional procedure can comprise a procedure performed using a product of a partner of the manufacturer of the system. [078] In some embodiments, the system is configured to request and/or receive potential customer data. The potential customer data can comprise data from vendors who sell cosmetic products. The potential customer data can comprise data from vendors who have similar customers to the customers of the manufacturer of the system. [079] In some embodiments, the system is configured to produce summary data reports. [080] In some embodiments, the system is configured to upload IOT data (“internet of things” data). The IOT data can be provided by a system component, such as the at least one treatment device. The IOT data can be provided by a non-system device. The IOT data can comprise microcoring treatment procedure data. The system can be configured to analyze the IOT data and produce an IOT analysis. The system can comprise a patient device including a patient app, and the system can be configured to modify the patient app based on the IOT analysis. The system can comprise a clinician device including a clinician app, and the system can be configured to modify the clinician app based on the IOT analysis. The system can comprise a vendor device including a vendor app, and the system can be configured to modify the vendor app based on the IOT analysis. The system can be configured to modify the at least one treatment device based on the IOT analysis. The system can be configured to modify one or more settings used in a microcoring treatment procedure. The system can be configured to produce information to send to a patient, and the produced information can be based on the IOT analysis. The system can be configured to perform a microcoring procedure based on the uploaded IOT data. The system can be configured to perform a microcoring procedure in a closed loop arrangement based on the uploaded IOT data. The system can be configured to receive images of a patient prior to the performance of a microcoring procedure on the patient.
Docket No. CYT-014-PCT [081] In some embodiments, the system further comprises a camera configured to collect the pre-procedure patient images. The system can comprise a patient device including a camera configured to collect the pre-procedure patient images. The system can be further configured to produce a treatment plan based on the pre-procedure patient images. The treatment plan can comprise proposed skin locations to be treated. The system can be further configured to identity potential treatment issues based on the pre-procedure patient images. The system can be configured to search for the pre-procedure patient images. The system can be configured to search one or more social media sites for the pre-procedure patient images. [082] In some embodiments, the system is configured to receive images of a patient after the performance of a microcoring procedure on the patient. The system can be further configured to monitor for an adverse condition based on the post-procedure patient images. The system can be further configured to produce a post-microcoring procedure treatment plan and to monitor and suggest a change in the post-microcoring procedure treatment plan based on the post-procedure patient images. The system can be configured to search for the post- procedure patient images. The system can be configured to search one or more social media sites for the post-procedure patient images. [083] In some embodiments, the system is configured to provide to the patient with a pre-microcoring procedure recommendation plan. The pre-microcoring recommendation plan can be configured to optimize the outcome of a microcoring procedure for the patient. The pre-microcoring recommendation plan can be based on one or more patient images. The system can be configured to automatically send out the pre-microcoring recommendation plan based on a schedule. The system can be further configured to continue to send the pre- microcoring recommendation plan until a confirmation of receipt from the patient is received. The pre-microcoring recommendation plan can comprise a recommended use of one or more cosmetic products. The system can be configured to provide an automated web link to buy the one or more cosmetic products. The selection of the one or more cosmetic products can be based on an input of a clinician. [084] In some embodiments, the system is configured to send a patient a post- microcoring procedure recommendation plan for that patient. The post-microcoring recommendation plan can be configured to optimize the outcome of a microcoring procedure for the patient. The post-microcoring recommendation plan can be based on one or more patient images. The patient images can comprise pre and/or post microcoring procedure patient images. The patient images can comprise pre and post microcoring procedure patient images. The system can be further configured to continue to send the post-microcoring
Docket No. CYT-014-PCT recommendation plan until a confirmation of receipt from the patient is received. The post- microcoring recommendation plan can comprise a recommended use of one or more cosmetic products. The system can be configured to provide an automated web link to buy the one or more cosmetic products. The selection of the one or more cosmetic products can be based on an input of a clinician. [085] In some embodiments, the system is configured to monitor patient browsing and produce browsing data. The system can be further configured to produce a recommendation of a microcoring procedure based on the browsing data. The system can be further configured to produce a recommendation of a complementary procedure to be performed based on the browsing data. The system can be further configured to recommend the purchase of a third-party product based on the browsing data. The system can be further configured to recommend a clinician product and/or procedure based on the browsing data. [086] In some embodiments, the system comprises a member clinician login function. The system can comprise one or more devices that can be modified based on use by a first clinician that has logged into the member clinician function. The modifications can comprise a bias toward preferences of the first clinician. The clinician login function can comprise multiple levels of membership. The multiple levels of membership can be related to multiple levels of preferences. [087] In some embodiments, the system is configured to provide one or more recommendations to a clinician. The one or more recommendations can comprise at least one recommendation to increase patient throughput for a clinician. [088] In some embodiments, the system is configured to provide a discount to a patient, a clinician, and/or a vendor. The system can be configured to provide the discount based on the patient scheduling an appointment within a pre-determined timeframe. The system can be configured to provide the discount based on the patient referring another patient. [089] In some embodiments, the system can be configured to receive a payment from a patient, a clinician, and/or a vendor. [090] In some embodiments, the system is configured to make a payment to a clinician, a vendor, and/or a patient. [091] In some embodiments, the system is configured to receive a payment from a vendor based on a product of that vendor being sold. [092] In some embodiments, the system is configured to provide treatment data to a receiving component of the system and/or and the system is configured to receive treatment data from a transmitting component of the system. The receiving component and/or the
Docket No. CYT-014-PCT transmitting component can comprise one, two, or more devices selected from the group consisting of: one or more patient devices; one or more clinician devices; one or more vendor devices; and combinations thereof. The system can be further configured to identify one or more of: movement of the at least one treatment device relative to the patient’s anatomy; smoothness of at least one treatment device movement; and/or detection of the at least one treatment device treating the same anatomical location of the patient. The system can be configured to: collect movement, position, and/or other data across multiple operators of the system; calculate population analytics to determine and identify operators that achieve and/or are likely to achieve optimized outcomes; and/or compare operator technique data of multiple operators such as to compare operators. [093] In some embodiments, the system is configured to share data with one or more of: a clinician; a patient; a parent of a patient; and/or an information portal. [094] In some embodiments, the system is configured to create one or more of: a community event; a training workshop such as an online training workshop; a consult, such as a virtual consult; and/or a virtual event. [095] In some embodiments, the system is configured to offer post-operative care via an online marketplace. The system can be configured to function as a broker between vendors, physicians, and/or patients. The system can be configured to sell one or more add-on products to a patient. [096] In some embodiments, the system is configured to allow a patient and/or other user of the system to transfer patient data to a social media platform. [097] In some embodiments, the system is configured to provide social media platform information to a patient or other user. [098] In some embodiments, the system is configured to allow a clinician and/or a vendor to create advertising materials. The system can further comprise a patient device, a server, and/or a network, and the system can be further configured to transmit the advertising materials to the patient device, the server, and/or the network. The system can be configured to post the advertising materials on the patient device, on television and/or radio, and/or on a website. [099] In some embodiments, the system is configured to provide references regarding one or more patients identified by the system as potential candidates for a microcoring or other procedure performed using the system. The one or more patients identified by the system can be identified based on a prediction performed by the system that indicates the one
Docket No. CYT-014-PCT or more patients are likely to achieve optimized or at least reasonable outcomes from the microcoring and/or other procedures to be performed using the system. [100] In some embodiments, the system is configured to create and/or provide advertising of a promotional event and/or other event, and the promotional event and/or other event is associated with the use of the system. The system can be configured to perform a function selected from the group consisting of: send a group email; provide information to a social media platform; provide information on a patient device, a clinician device, and/or a vendor device; and combinations thereof. The system can be configured to organize and/or otherwise cause to occur: one or more virtual events; one or more live events; or both. [101] In some embodiments, the system is configured to allow a patient to enter a desired procedure into memory of the system, and the system is further configured to provide feedback to the patient. The feedback provided can comprise: one or more system created predicted images of the patient approximating the appearance of the patient after the desired procedure can be performed; an assessment of the appropriateness of the desired procedure for the patient; one or more alternative suggested procedures; and/or combinations of these. The system can be configured to produce a three-dimensional selfie representing the current condition of the patient, and/or representing a predicted outcome of a microcoring, and/or other procedure performed on that patient using the system. The system can produce the three-dimensional selfie by stitching multiple two-dimensional images, using augmented reality, or both. [102] In some embodiments, the system is configured to provide a clinician suggestion to a patient, and the clinician suggestion comprises a recommendation of a particular clinician type or a particular clinician. The system can determine the clinician suggestion based on patient data and/or clinician data. The patient data and/or clinician data can comprise data selected from the group consisting of: patient images; patient desired outcomes data; patient physiologic data; patient location data; patient demographic data; patient financial data; clinician performance data; clinician skill level data; clinician office location data; clinician available techniques and/or equipment data; and combinations thereof. The system can be configured to determine the clinician suggestion based on an analysis of a set of multiple clinicians, and the analysis identifies clinicians that have treated the highest quantity of similar profile patients. [103] In some embodiments, the system is configured to harvest data to perform a registry study. The system can be configured to reduce the complexity of the patient- consenting process. The system can be configured to support and/or enhance enrollment of
Docket No. CYT-014-PCT patients from multiple clinical practices into a multi-site study. The system can be configured to provide collaborative clinical study tools. The system can be configured to provide an automated creation of documents for submittal to an internal review board. [104] In some embodiments, the at least one treatment device further comprises a functional element comprising: one or more sensors; one or more transducers; and/or one or more other components. The functional element can comprise one or more transducers configured to provide tactile feedback to an operator. The tactile feedback can be configured to cause the operator to better hold and/or better position the at least one treatment device during microcoring. The functional element can further comprise one or more accelerometers and/or one or more other sensors configured to track movement and/or position of the at least one treatment device. [105] In some embodiments, the system further comprises a skin modification device. The skin modification device can comprise one, two, or more products selected from the group consisting of: hyaluronic acid; a moisturizer; an analgesic; a peptide; exosomes; platelet-rich plasma (PRP); arnica montana extract; a vasoconstrictor; methotrexate; minoxidil; stem cells; botulinum toxin; a corticosteroid; and combinations thereof. [106] The technology described herein, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings in which representative embodiments are described by way of example. INCORPORATION BY REFERENCE [107] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. It will be clearly understood that, if a prior art publication is referred to herein, this reference does not constitute an admission that the publication forms part of the common general knowledge in the art in Australia or in any other country. BRIEF DESCRIPTION OF THE DRAWINGS [108] Fig.1 illustrates a block diagram of a system for treating and/or diagnosing tissue, consistent with the present inventive concepts. [109] Fig.2 illustrates a side view of a coring element being introduced into the skin, consistent with the present inventive concepts.
Docket No. CYT-014-PCT [110] Fig.3A illustrates an end view of a needle, consistent with the present inventive concepts. [111] Figs.3B and 3C illustrate a side view of a needle, consistent with the present inventive concepts. [112] Fig.3D illustrates a sectional view of a needle, consistent with the present inventive concepts. [113] Fig.4 illustrates a block diagram of a system for treating and/or diagnosing tissue, consistent with the present inventive concepts. DETAILED DESCRIPTION OF THE DRAWINGS [114] Reference will now be made in detail to the present embodiments of the systems, devices, and methods (singly or collectively “technology” or “technologies” herein), examples of which are illustrated in the accompanying drawings. Similar reference numbers may be used to refer to similar components. However, the description is not intended to limit the present disclosure to particular embodiments, and it should be construed as including various modifications, equivalents, and/or alternatives of the embodiments described herein. [115] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) can be combined in any given way. [116] It is to be understood that at least some of the figures and descriptions of the invention have been simplified to focus on elements that are relevant for a clear understanding of the invention, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the invention. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the invention, a description of such elements is not provided herein. [117] Terms defined in the present disclosure are only used for describing specific embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. Terms provided in singular forms are intended to include plural forms as well, unless the context clearly indicates otherwise. All of the terms used herein, including technical or scientific terms, have the same meanings as those generally understood by an
Docket No. CYT-014-PCT ordinary person skilled in the related art, unless otherwise defined herein. Terms defined in a generally used dictionary should be interpreted as having meanings that are the same as or similar to the contextual meanings of the relevant technology and should not be interpreted as having ideal or exaggerated meanings, unless expressly so defined herein. In some cases, terms defined in the present disclosure should not be interpreted to exclude the embodiments of the present disclosure. [118] It will be understood that the words "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include") and/or "containing" (and any form of containing, such as "contains" and "contain") when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. [119] It will be further understood that, although the terms first, second, third, etc. may be used herein to describe various limitations, elements, components, regions, layers and/or sections, these limitations, elements, components, regions, layers and/or sections should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer or section from another limitation, element, component, region, layer or section. Thus, a first limitation, element, component, region, layer or section discussed below could be termed a second limitation, element, component, region, layer or section without departing from the teachings of the present application. [120] It will be further understood that when an element is referred to as being "on", "attached", "connected" or "coupled" to another element, it can be directly on or above, or connected or coupled to, the other element, or one or more intervening elements can be present. In contrast, when an element is referred to as being "directly on", "directly attached", "directly connected" or "directly coupled" to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., "between" versus "directly between," "adjacent" versus "directly adjacent," etc.). [121] It will be further understood that when a first element is referred to as being "in", "on" and/or "within" a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g., within a wall of the second element); positioned on an external and/or internal surface of the second element; and combinations of two or more of these.
Docket No. CYT-014-PCT [122] As used herein, the term “proximate”, when used to describe proximity of a first component or location to a second component or location, is to be taken to include one or more locations near to the second component or location, as well as locations in, on and/or within the second component or location. For example, a component positioned proximate an anatomical site (e.g., a target tissue location), shall include components positioned near to the anatomical site, as well as components positioned in, on and/or within the anatomical site. [123] Spatially relative terms, such as "beneath," "below," "lower," "above," "upper" and the like may be used to describe an element and/or feature's relationship to another element(s) and/or feature(s) as, for example, illustrated in the figures. It will be further understood that the spatially relative terms are intended to encompass different orientations of the device in use and/or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as "below" and/or "beneath" other elements or features would then be oriented "above" the other elements or features. The device can be otherwise oriented (e.g., rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. [124] The terms “reduce”, “reducing”, “reduction” and the like, where used herein, are to include a reduction in a quantity, including a reduction to zero. Reducing the likelihood of an occurrence shall include prevention of the occurrence. Correspondingly, the terms “prevent”, “preventing”, “prevention” and the like, where used herein, shall include the acts of “reduce”, “reducing”, and “reduction”, respectively. [125] The term "and/or" where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example "A and/or B" is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein. [126] The term “one or more”, where used herein can mean one, two, three, four, five, six, seven, eight, nine, ten, or more, up to any number. [127] The terms “and combinations thereof” and “and combinations of these” can each be used herein after a list of items that are to be included singly or collectively. For example, a component, process, and/or other item selected from the group consisting of: A; B; C; and combinations thereof, shall include a set of one or more components that comprise: one, two, three or more of item A; one, two, three or more of item B; and/or one, two, three, or more of item C. [128] In this specification, unless explicitly stated otherwise, “and” can mean “or”, and “or” can mean “and”. For example, if a feature is described as having A, B, or C, the feature
Docket No. CYT-014-PCT can have A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, the feature can have only one or two of A, B, or C. [129] The expression “configured (or set) to” used in the present disclosure may be used interchangeably with, for example, the expressions “suitable for”, “having the capacity to”, “designed to”, “adapted to”, “made to” and “capable of” according to a situation. The expression “configured (or set) to” does not mean only “specifically designed to” in hardware. Alternatively, in some situations, the expression “a device configured to” may mean that the device “can” operate together with another device or component. [130] As used herein, the term “threshold” refers to a maximum level, a minimum level, and/or range of values correlating to a desired or undesired state. In some embodiments, a system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and/or outside a threshold range of values, such as to cause a desired effect (e.g., efficacious therapy) and/or to prevent or otherwise reduce (hereinafter “prevent”) an undesired event (e.g., a device and/or procedural adverse event). In some embodiments, a system parameter is maintained above a first threshold (e.g., above a first temperature threshold to cause a desired therapeutic effect to tissue) and below a second threshold (e.g., below a second temperature threshold to prevent undesired tissue damage). In some embodiments, a threshold value is determined to include a safety margin, such as to account for patient variability, system variability, tolerances, and the like. As used herein, “exceeding a threshold” relates to a parameter going above a maximum threshold, below a minimum threshold, within a range of threshold values and/or outside of a range of threshold values. [131] As described herein, “room pressure” shall mean pressure of the environment surrounding the systems and devices of the present inventive concepts. “Positive pressure” includes pressure above room pressure or simply a pressure that is greater than another pressure, such as a positive differential pressure across a fluid pathway component such as a valve. “Negative pressure” includes pressure below room pressure or a pressure that is less than another pressure, such as a negative differential pressure across a fluid component pathway such as a valve. Negative pressure can include a vacuum but does not imply a pressure below a vacuum. As used herein, the term “vacuum” can be used to refer to a full or partial vacuum, or any negative pressure as described hereinabove. [132] The term “diameter” where used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described. For example, when describing a cross section, such as the cross section of a component, the
Docket No. CYT-014-PCT term “diameter” shall be taken to represent the diameter of a hypothetical circle with the same cross-sectional area as the cross section of the component being described. [133] The terms “major axis” and “minor axis” of a component where used herein are the length and diameter, respectively, of the smallest volume hypothetical cylinder which can completely surround the component. [134] As used herein, the term “fluid” can refer to a liquid, gas, gel, or any flowable material, such as a material which can be propelled through a lumen and/or opening. [135] As used herein, the term “material” can refer to a single material, or a combination of two, three, four, or more materials. [136] As used herein, the term “conduit” or “conduits” can refer to an elongate component that can include one or more flexible and/or non-flexible filaments selected from the group consisting of: one, two or more wires or other electrical conductors (e.g., including an outer insulator); one, two or more wave guides; one, two or more hollow tubes, such as hydraulic, pneumatic, and/or other fluid delivery tubes; one or more optical fibers; one, two or more control cables and/or other mechanical linkages; one, two or more flex circuits; and combinations of these. A conduit can include a tube including multiple conduits positioned within the tube. A conduit can be configured to electrically, fluidically, sonically, optically, mechanically, and/or otherwise operably connect one component to another component. [137] As used herein, the term “transducer” is to be taken to include any component or combination of components that receives energy or any input and produces an output. For example, a transducer can include an electrode that receives electrical energy and distributes the electrical energy to tissue (e.g., based on the size of the electrode). In some configurations, a transducer converts an electrical signal into any output, such as: light (e.g., a transducer comprising a light emitting diode or light bulb); sound (e.g., a transducer comprising one or more piezoelectric and/or CMUT transducers configured to deliver and/or receive ultrasound energy); pressure (e.g., an applied pressure or force); heat energy; cryogenic energy; chemical energy; mechanical energy (e.g., a transducer comprising a motor or a solenoid); magnetic energy; and/or a different electrical signal (e.g., different than the input signal to the transducer). Alternatively or additionally, a transducer can convert a physical quantity (e.g., variations in a physical quantity) into an electrical signal. A transducer can include any component that delivers energy and/or an agent to tissue, such as a transducer configured to deliver one or more of: heat energy to tissue; cryogenic energy to tissue; electrical energy to tissue (e.g., a transducer comprising one or more electrodes); light energy to tissue (e.g., a transducer comprising a laser, light emitting diode and/or optical
Docket No. CYT-014-PCT component such as a lens or prism); mechanical energy to tissue (e.g., a transducer comprising a tissue manipulating element); sound energy to tissue (e.g., a transducer comprising one or more piezoelectric and/or CMUT transducers); chemical energy; electromagnetic energy; magnetic energy; and combinations of two or more of these. Alternatively or additionally, a transducer can comprise a mechanism, such as: a valve; a grasping element; an anchoring mechanism; an electrically-activated mechanism; a mechanically-activated mechanism; and/or a thermally activated mechanism. [138] As used herein, the term “functional element” is to be taken to include one or more elements constructed and arranged to perform a function. A functional element can comprise one or more sensors and/or one or more transducers. In some embodiments, a functional element is configured to deliver energy to tissue, such as to treat and/or image tissue. In some embodiments, a functional element comprises one or more hollow filaments (e.g., one or more needles) that are configured to be inserted into tissue and/or withdrawn from tissue, such as to perform a microcoring treatment as described herein. In some embodiments, a functional element (e.g., comprising one or more sensors) can be configured to record one or more parameters, such as a patient physiologic parameter; a patient anatomical parameter (e.g., a tissue parameter); a patient environment parameter; and/or a system parameter (e.g., temperature and/or pressure within the system). In some embodiments, a sensor or other functional element is configured to perform a diagnostic function (e.g., to gather data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g., perform a microcoring procedure, deliver therapeutic energy, and/or deliver a therapeutic agent). In some embodiments, a functional element comprises one or more elements constructed and arranged to perform a function selected from the group consisting of: core and/or remove tissue; deliver energy; extract energy (e.g., to cool a component); deliver a drug or other agent; manipulate a system component or patient tissue; record or otherwise sense a parameter such as a patient physiologic parameter or a patient anatomical parameter; and combinations of two or more of these. A “functional assembly” can comprise an assembly constructed and arranged to perform a function, such as are described hereinabove. In some embodiments, a functional assembly is configured to core tissue and/or otherwise treat tissue (e.g., a functional assembly configured as a treatment assembly or treatment module). Alternatively or additionally, a functional assembly can be configured as a diagnostic assembly that records one or more parameters, such as a patient physiologic parameter; a patient anatomical parameter; a patient environment parameter; and/or a system parameter.
Docket No. CYT-014-PCT A functional assembly can comprise a deployable assembly, such as a robotically controlled assembly. A functional assembly can comprise one or more functional elements. [139] As used herein, the term “agent” shall include but not be limited to one or more agents selected from the group consisting of: an agent configured to improve and/or maintain the health of a patient; a drug (e.g., a pharmaceutical drug); a hormone; a protein; a protein derivative; a small molecule; an antibody; an antibody derivative; an excipient; a reagent; a buffer; a vitamin; a nutraceutical; and combinations of these. [140] As used herein, the term “target tissue” comprises one or more volumes of tissue of a patient to be diagnosed and/or treated, such as a treatment comprising a microcoring procedure as described herein. Similarly, a “treatment target” or “tissue target” comprises one or more volumes of tissue to be diagnosed and/or treated. “Safety margin tissue” comprises tissue whose treatment (e.g., receiving of a microcoring treatment) yields no significant adverse effect to the patient. “Non-target tissue” comprises tissue that is not intended to receive treatment (e.g., not intended to receive a microcoring treatment). [141] As used herein, the term “system parameter” comprises one or more parameters of the system of the present inventive concepts. A system parameter can comprise one or more “tissue treatment parameters” (also referred to as “tissue treatment settings”), such as one, two or more tissue treatment parameters selected from the group consisting of: a “microcoring parameter” (also referred to as a “coring parameter” herein), such as a reciprocating motion parameter as described herein; a target level of a patient parameter such as a patient diagnostic parameter and/or a patient environment parameter as described herein; a tissue-type parameter; a tissue target area parameter; a tissue anatomical location area parameter; and combinations of these. Microcoring parameters include but are not limited to: depth of penetration of a coring element; duration and/or speed of penetration of a coring element such as rise time of speed of penetration of a coring element; penetration dwell time (also referred to as “hold time”); duration and/or speed of withdrawal of a coring element; time between penetrations; density of coring (also referred to as “microcoring density”); spacing between coring elements; coring diameter; location of penetration; coring suction force; skin suction force (e.g., vacuum pressure and contact area); vacuum “pinch” time (e.g., time to release skin suction); vacuum regeneration time (e.g., as dictated by tubing and/or filter volume and controlled leaks in the system); frequency of coring; inner diameter surface friction of coring element; and combinations of these. A system parameter can comprise a parameter selected from the group consisting of: a tissue treatment parameter; a microcoring parameter; an energy delivery parameter; a pressure level; a temperature level; an energy
Docket No. CYT-014-PCT level; a power level; a frequency level; an amplitude level; a battery level; a threshold level for an alarm or other alert condition; and combinations of these. A system parameter can include one or more tissue targets identified to be treated (e.g., areas of skin tissue to be treated), such as tissue targets identified for treatment by an operator and/or by an algorithm of the system. [142] As used herein, the term “patient parameter” comprises one or more parameters associated with the patient. A patient parameter can comprise a patient physiologic parameter, such as a physiologic parameter selected from the group consisting of: temperature (e.g., tissue temperature); pressure such as blood pressure or other body fluid pressure; pH; a blood gas parameter; blood glucose level; hormone level; heart rate; respiration rate; and combinations of these. Alternatively or additionally, a patient parameter can comprise a patient environment parameter, such as an environment parameter selected from the group consisting of: patient geographic location; temperature; pressure; humidity level; light level; time of day; and combinations of these. [143] As used herein, the term “image data” comprises data created by one or more imaging devices. Image data can include data related to target tissue, safety margin tissue, and non-target tissue. Image data can also include data related to any implants or other non- tissue objects that are proximate tissue being imaged. Image data can be processed by one or more algorithms of the present inventive concepts, such as to determine one or more locations to treat (e.g., target tissue identified to be ablated or otherwise receive microcoring or other treatment), and/or to determine one or more locations to which treatment (e.g., microcoring) is to be avoided (e.g., non-target tissue). Image data can comprise data produced by a single imaging component, or from multiple imaging components. [144] As used herein, the term “transmitting a signal” and its derivatives shall refer to the transmission of power and/or data between two or more components, in any direction, such as via wired or wireless connections. [145] As used herein, the term “patient use data” shall refer to data related to use of the tissue treatment systems of the present inventive concepts on a patient (e.g., use of the system in a diagnostic and/or therapeutic procedure performed on a patient). The data can include but is not limited to: operating parameters such as tissue treatment parameters; target tissue parameters such as location of target tissue and/or amount of target tissue to be treated; patient parameters such as patient physiologic parameters and/or patient location or other patient environment parameters; operator parameters; site parameters; and combinations of these. Patient use data can include data from multiple patients, such as data collected from
Docket No. CYT-014-PCT multiple patients that interface with (e.g., receive a treatment from) one or more systems of the present inventive concepts. In some embodiments, an algorithm of the present inventive concepts uses patient use data from one or more patients to determine a system parameter to be used in performing a skin treatment procedure on a patient. [146] As used herein, the term “critical structure” shall refer to a particular structure to which a treatment (e.g., a particular microcoring procedure) should be avoided. [147] As used herein, the term “microcoring treatment plan” or simply a “treatment plan” shall refer to a set of treatment variables (e.g., reciprocating motion parameters and/or other microcoring parameters) and/or a set of treatment locations (e.g., microcoring treatment locations) that can be created to define a future microcoring treatment to be performed. In some embodiments, a system of the present inventive concepts produces one, two, or more microcoring treatment plans based on various data (e.g., patient data) recorded by the system, and/or data input into the system (e.g., by an operator of the system). [148] The systems, devices, and methods of the present inventive concepts can be configured for treating skin (e.g., eliminating tissue volume, tightening skin, lifting skin, reducing skin laxity, and/or otherwise providing a cosmetic effect), such as by selectively excising a plurality of microcores of patient tissue. In some embodiments, the tissue is treated without thermal energy being imparted to surrounding (e.g., non-excised) tissue. These systems, devices, and methods satisfy an unmet need for rapid and safe treatment of skin (“skin” or “skin tissue” herein), including, for example, faster pretreatment preparation and post-treatment healing times as compared to current surgical and thermal treatment methods. [149] In general, the term “microcoring,” as used herein, refers to technologies that utilize one or more (in some embodiments, a plurality, e.g., an array) hollow needles, or other non-thermal treatment elements (e.g., blades, tubes, and/or drills) that remove and/or otherwise treat tissue of a patient. These treatment elements can be of sufficiently small dimension (e.g., comprise a sufficiently small diameter) to minimize the extent of bleeding and/or clotting within holes or slits, and/or to minimize scar formation, when used to excise (e.g., and optionally sequester) tissue from a site. In some embodiments, excising a tissue means forming a tissue portion (e.g., a “microcore”), such as by inserting a hollow needle into the site so that the tissue portion is formed inside the hollow needle and severed from surrounding tissue, whereby a microcore that is separated (e.g., physically separated) from other tissue is generated.
Docket No. CYT-014-PCT [150] In some embodiments, microcoring elements, assemblies, and/or other components as described herein may include a component configured to perform sequestration of the excised tissue. As used herein, the term “sequestering”, when used in reference to tissue, means excising a microcore and then removing the excised microcore from the excision site. In certain embodiments, sequestered tissue may be permanently disposed. In certain embodiments, sequestered tissue may be used for diagnostic purpose, such as when used for biopsy and/or histology analyses, such as those known in the art. In some embodiments, technologies provided herein maximize removal and/or minimize risk of (partial or complete) re-insertion of extracted tissue. [151] It should be understood that particular microcoring technologies using hollow needles specifically described herein serve for exemplary and/or illustrative purposes, and that other techniques and devices can be used to create microcores. Microcoring technologies described herein may include a number of advantageous features. For example, provided technologies may enable visualization of results in real time during the course of the treatment, such as through feedback (e.g., patient and/or operator feedback) and subsequent treatment adjustment in real time. [152] Alternatively or additionally, the systems and devices of the present inventive concepts that are used for microcoring can include micro-sized features that may be beneficial for controlling extent of skin treatment and/or minimize adverse effects of the skin treatment. [153] Still further, in some embodiments, technologies described herein may require less skill than that of a surgeon. Thus, in certain embodiments, a patient may be treated by a non- physician professional and/or in an outpatient setting, rather than in an inpatient, surgical setting. In some embodiments, a patient may be treated at a spa, at a cosmetic salon, or at home. That is, the technologies of the present inventive concepts are amenable to and/or permit consistent and/or reproducible administration of skin treatment procedures in a variety of treatment settings, and with a broad range of technicians and/or other operators (“operators” herein) performing the procedures. [154] In some embodiments, the technologies described herein may have generally a lower risk profile and/or the technologies can provide more predictable results and/or risk factors than those for more invasive techniques (e.g., plastic surgery) or energy-based techniques (e.g., laser, radiofrequency (RF), or ultrasound), which may or may not be invasive.
Docket No. CYT-014-PCT [155] In some embodiments, non-thermal fractional excision technologies described herein allow skin tightening, skin lifting, and/or reduction of skin laxity without (or with significant reduction of) one or more common side effects of thermal treatment methods (e.g., thermal ablation and/or other treatment methods that increase and/or otherwise modify the temperature of tissue in order to provide a treatment to that tissue). Thermal ablation techniques prevent and/or inhibit skin tightening by allowing coagulation of tissue and formation of rigid tissue cores that cannot be compressed. Thermal ablation techniques create a three-dimensional heat-affected zone (HAZ) surrounding an immediate treatment site. While fractional ablative lasers may be used on or near heat-sensitive sites (e.g., eyes, nerves), for example when the laser does not penetrate more than 1 mm into the skin (resulting in a comparatively small HAZ), other thermal ablation techniques (e.g., ultrasound- based techniques and radiofrequency-based techniques) cannot be used in the vicinity of heat- sensitive sites because the HAZ may extend to heat sensitive tissues potentially causing undesired damage (e.g., permanent undesired damage). As will be appreciated by those skilled in the art, a “heat-sensitive site” is a site where exposure to radiation and/or elevated temperature is associated with a relatively high risk of unacceptable cosmetic and/or physiologic outcomes. In any event, technologies of the present inventive concepts described herein have generally a lower risk profile than, for example, thermal methods, at least in part due to a zone of tissue injury that is smaller than the zone of injury (e.g., the HAZ) of thermal methods. [156] In some embodiments, advantages of certain technologies described herein include a therapeutic benefit selected from the group consisting of: a particularly low (e.g., lesser than that observed with other techniques such as invasive techniques and/or thermal techniques) degree of erythema; faster resolution of erythema; lower percent incidence, severity, and/or term of skin discoloration (hyperpigmentation or hypopigmentation); low swelling and/or inflammation (e.g., as compared with that observed with laser treatment and/or with ultrasound-based treatment); and combinations of these. [157] In some embodiments, the technologies provided herein can allow for rapid closing of holes and/or slits after excising tissue (e.g., within a few seconds after treating skin, such as within ten seconds), thereby minimizing extent of bleeding and/or clotting within holes and/or slits, and/or minimizing the extent of scar formation. [158] In some embodiments, the technologies provided herein may be useful for maximizing treatment effect while minimizing treatment time, such as by using rapid-fire
Docket No. CYT-014-PCT reciprocating needles or needle arrays, and/or by using large needle arrays that allow for simultaneous excision of tens, hundreds, or even thousands of microcores. [159] In some embodiments, the technologies described herein may be useful for maximizing tightening effect while minimizing healing time and/or minimizing the time in which a cosmetic effect occurs, such as by optimizing tightening (e.g., by controlling the extent of skin pleating, such as by increasing the extent of skin pleating for some applications or skin regions and/or by decreasing the extent of skin pleating for other applications or skin regions, as described herein). [160] In some embodiments, the technologies described herein may provide efficient clearance of sequestered and/or partially ablated tissue, and/or provide efficient clearance of debris from ablated tissue portions, thus reducing time for healing and/or improving the skin tightening treatment (e.g., relative to laser-based and/or other thermal technologies). [161] In some embodiments, the technologies described herein may be configured to allow for efficient and effective positioning of skin prior to, during, and/or after tissue excision (e.g., excision including tissue sequestration). Positioning the skin can be critical to control skin-tightening direction, and it can ensure treatment occurs in the desired location and desired dimensions (e.g., thickness, width in a preferred direction, such as along or orthogonal to Langer lines). [162] Among other things, the systems, devices, and methods of the present inventive concepts can include microcoring technologies that are configured to achieve desirable (e.g., reduced) procedure times and/or can significantly improve one or more aspects of healing from a tissue treatment procedure (e.g., a tissue removal procedure), such as when compared to thermal methods. [163] Described herein are technologies, methods, and/or devices for treating skin, such as by selectively microcoring skin tissue. In particular, described herein are hollow needles or other hollow filaments (“needles” herein), as well as related systems (e.g., including kits), devices, and methods, capable of microcoring tissue portions by capturing and retaining the tissue portions inside a lumen of one or more hollow needles after insertion into and withdrawal from the skin. Microcored tissue portions can be removed from a lumen of a hollow needle and discarded. The process can be repeated to generate multiple microcored (also referred to as “cored” herein) skin tissue portions, in particular over a desired area of skin and located at chosen sites of the body of a patient. The hollow needles, kits, devices, methods, and other technologies described herein may provide increased effectiveness over
Docket No. CYT-014-PCT currently available apparatuses and techniques while maintaining convenience, affordability, and accessibility to patients desiring tissue restoration. [164] In some embodiments, technologies described herein include a treatment device, such as a handheld treatment device. An example treatment device may include a treatment module (e.g., a needle hub) comprising at least one hollow needle configured to remove a portion of the skin tissue (e.g., a microcore) when the hollow needle is inserted into and withdrawn from the skin tissue. In some embodiments, a treatment device may include an activation assembly (e.g., a translation and/or actuation assembly) connected to the treatment module, such as to translate (e.g., along one, two, and/or three axes) and/or actuate the treatment module in one or more directions relative to a surface of the skin tissue. In some embodiments, a treatment device may include a spacer to stabilize and/or maintain a constant position of the treatment device relative to the surface of the patient’s skin tissue. In some embodiments, a treatment device may include a hand piece including a hand piece shell, such as a housing that at least partially encases the activation assembly. In some embodiments, a hand piece and/or hand piece shell may include or may be connected to a spacer, such as a connection at a distal end of a treatment device (e.g., an end of a treatment device for contacting skin). [165] Referring now to Fig.1, a schematic view of a tissue treatment system is illustrated, consistent with the present inventive concepts. System 10 can be configured to perform a skin and/or other tissue treatment procedure on a mammalian subject (also referred to as “patient” or “individual” herein). A tissue treatment procedure performed using system 10 can include the performance of one or more procedures, such as one or more diagnostic procedures and/or one or more treatment procedures (e.g., a tissue treatment procedure) performed on a mammalian subject. In some embodiments, system 10 is used by a clinician or other operator (“clinician” or “operator” herein) to perform one, two or more procedures, that are performed within a single day or over multiple days. System 10 can be configured to diagnose and/or treat one or more conditions of the subject to be treated (e.g., skin conditions, cosmetic issues, and/or other conditions of the subject to be treated). System 10 can be configured to treat and/or diagnose one or more portions (e.g., volumes) of patient tissue, “target tissue” herein. In some embodiments, system 10 comprises one, two or more devices that are configured to treat target tissue, such as to improve cosmesis of the patient (e.g., via microcoring as described herein). In some embodiments, system 10 is of similar construction and arrangement, and can include similar components, to the systems described
Docket No. CYT-014-PCT in applicant’s co-pending United States Patent Application Serial Number 17/291,235, titled "Systems and Methods for Skin Treatment", May 4, 2021. [166] System 10 can include one or more devices that are configured to gather various forms of patient information, patient data PD or data PD herein. For example, system 10 can include one or more devices or other components configured to collect patient data PD comprising patient diagnostic data, diagnostic data DD or data DD herein. Diagnostic data DD can comprise data related to a physiologic parameter of the patient, data related to the anatomy of the patient, data related to the environment of the patient (e.g., the current environment of the patient), and/or other patient-related data. Alternatively or additionally system 10 can include one or more devices or other components configured to collect patient use data (e.g., as defined herein). Alternatively or additionally, system 10 can include one or more devices or other components configured to collect patient data PD comprising patient image data, image data ID, which can comprise image data of tissue and/or one or more objects proximate tissue. Patient data PD can include data that is used in determining (e.g., by system 10 and/or an operator of system 10) a diagnosis and/or prognosis (either or both, “diagnosis” herein) for the patient. Alternatively or additionally, patient data PD can include patient data that is used in a tissue treatment procedure (e.g., by system 10 and/or an operator of system 10), such as to guide or otherwise affect a microcoring and/or other treatment performed on the patient. Image data ID can include image data related to: target tissue; safety margin tissue; non-target tissue; an implanted diagnostic and/or a treatment device; a foreign body (e.g., a splinter, tattoo, and the like); and combinations of these. System 10 can be configured to produce image data ID through the delivery of energy, such as X-ray energy, sound energy (e.g., ultrasound energy), and/or light energy that is delivered and whose reflections and/or other transmissions are collected in order to produce image data ID. In some embodiments, image data ID comprises data related to tissue comprising blood, such as when image data ID comprises blood flow data (e.g., as obtained using Doppler ultrasound). [167] As used herein, a “tissue diagnostic procedure”, a “tissue diagnostic”, and their derivatives include but are not limited to: collection of diagnostic data DD; collection of image data ID (e.g., when system 10 records reflections and/or other transmissions of delivered X-ray, ultrasound, light, and/or other energy, and converts these recordings into image data ID); delivery of energy to tissue to characterize the tissue (e.g., when system 10 records one or more effects on the tissue due to the energy delivery, such as using spectroscopy); and/or recording of one or more tissue properties using one or more sensors and/or imaging devices of system 10. A tissue diagnostic procedure can also include a
Docket No. CYT-014-PCT procedure in which various patient parameters are collected, such as patient environment parameters and/or a patient physiologic parameter, for example as described herein. [168] As used herein, a “tissue treatment procedure”, a “tissue treatment”, and their derivatives include but are not limited to: microcoring of tissue; removal of tissue; ablation of tissue; causing the necrosis of tissue; reducing the volume of tissue (e.g., debulking tissue); stimulating tissue; improving the strength of tissue (e.g., muscle tissue); manipulating and/or otherwise applying a force to tissue; stiffening tissue; and/or otherwise providing a cosmetic enhancement and/or other therapeutic effect to tissue. [169] System 10 includes treatment device 100 which can comprise one, two or more treatment devices that are configured to perform a treatment procedure on a patient (e.g., a microcoring or other tissue treatment procedure). Treatment device 100 can be configured to treat target tissue (e.g., perform a microcoring of target tissue). Alternatively or additionally, treatment device 100 can be configured to diagnose target tissue (e.g., gather diagnostic data DD and/or image data ID). Treatment device 100 can include one or more modules, treatment module 150 shown, each of which can be configured to perform a patient treatment (e.g., a microcoring treatment). Treatment module 150 can comprise one, two, three or more filaments for coring tissue, coring elements 155 shown. Treatment device 100 can include actuation assembly 120 shown, which can comprise one, two or more assemblies configured to interface with treatment module 150, such as is described herein. Treatment device 100 can include spacer assembly 180 shown, which can comprise one or more assemblies that are constructed and arranged to be positioned between a corresponding one or more treatment modules 150 and tissue. [170] System 10 can include console 500 shown, which can comprise one, two or more discrete devices, where each of which can operably attach to one, two or more treatment devices 100, simultaneously and/or sequentially. Console 500 can include a connector, connector 505 as shown, which can be configured to operably attach (e.g., electrically, mechanically, fluidly, optically, sonically, and/or otherwise operably attach) to treatment device 100, such as via cable 103 of treatment device 100. Console 500 can be configured to allow an operator to control one or more treatment devices, such as via user interface 510 shown. Console 500 can comprise various assemblies and other components, as described herein, which singly or in combination are configured to provide to treatment device 100 one or more of: energy; mechanical, hydraulic, and/or pneumatic linkages; an agent (e.g., agent 60 described hereinbelow); and/or control signals. Console 500 can be configured to receive data from treatment device 100. In some embodiments, all or a portion of a console 500 is
Docket No. CYT-014-PCT integrated into a treatment device 100 (e.g., the treatment device 100 is a relatively stand- alone device). Console 500, and/or another component of system 10, can comprise one or more algorithms, algorithm 25 shown. In some embodiments, treatment device 100 and/or another component of system 10 comprises all or a portion of algorithm 25. [171] Algorithm 25 can analyze various information related to: microcoring procedures performed using system 10 (e.g., using treatment device 100); information uploaded into system 10 via patient device 300, clinician device 400, and/or vendor device 700 (each as described herein); information obtained from healthcare records (e.g., electronic healthcare records) of a hospital, clinician’s office, and/or other clinical setting; information obtained from network 80 (e.g., the Internet); and/or combinations of these. In some embodiments, algorithm 25 is configured to determine one or more microcoring parameters for a particular patient, and the information analyzed by algorithm 25 to determine these parameters comprises data such as: patient data PD described herein; clinician data CD described herein; vendor data VD described herein, and/or other data related to the patient, one or more clinicians, one or more vendors, and/or system 10. [172] In some embodiments, algorithm 25 is configured to be adjusted, such as by a clinician, such as to adjust an algorithm 25 configured to determine one or more microcoring parameters and/or one or more parameters associated with post-microcoring care. [173] System 10 can include imaging device 50 shown, which can comprise one, two or more imaging devices. Imaging device 50 can be configured to collect image data ID. In some embodiments, imaging device 50 comprises one, two or more imaging devices selected from the group consisting of: a fluoroscope or other X-ray imaging device; an ultrasound imager; a CT scanner; an MRI; an OCT imaging device; a camera such as a visual light camera and/or an infrared camera; and combinations of these. Imaging device 50 can comprise a device configured to characterize and/or otherwise collect data related to one or more properties of tissue, such as a device (e.g., an ultrasound-based device) configured to measure elasticity of tissue and/or other tissue property (e.g., with or without collecting an image of the tissue). In some embodiments, image data ID provided by imaging device 50 can be used to determine a target area to treat with system 10, and/or a non-target area to which treatment should be avoided. For example, algorithm 25 can be configured to analyze image data ID and provide feedback (e.g., suggestions and/or requirements) for particular tissue areas to be classified as target areas and/or non-target areas. In some embodiments, algorithm 25 is configured to identify one or more implants or other objects present under the patient’s skin, to which treatment should be adjusted (e.g., avoided), such as an under-the-
Docket No. CYT-014-PCT skin object comprising: an implant (e.g., implant 70 described hereinbelow) such as a cosmetic implant; a splinter; and/or tattoo ink. In these embodiments, algorithm 25 can be configured to identify a periphery of the under-the-skin object, such as to define a non-target zone including at least the area within the periphery (e.g., and also including a safety margin outside of the periphery). [174] System 10 can include agent 60 shown, which can comprise one or more pharmaceuticals and/or other agents that can be delivered to the patient. Agent 60 can comprise an agent that is applied topically and/or an agent that is delivered systemically (e.g., orally). Agent 60 can comprise one, two, or more agents selected from the group consisting of: hyaluronic acid; a moisturizer; an analgesic; a peptide; an exosome; platelet rich plasma (PRP); arnica montana extract; a vasoconstrictor; methotrexate; minoxidil; stem cells; botulinum toxin; a corticosteroid; and combinations of these. Agent 60 can comprise an agent that is applied topically, and or inserted into the patient, such as when injected or otherwise inserted into the dermis of the patient, such as when deposited in or otherwise proximate one or more target areas to be treated (e.g., pre-microcoring), during treatment (e.g., when deposited via coring elements 155 or otherwise), and/or after treatment (e.g., after microcoring). In some embodiments, a functional element 99 (e.g., as described hereinbelow) comprises a delivery device configured to deliver agent 60, such as a syringe, needle, transdermal patch, microfluidic pump, and/or other delivery device configured to deliver agent 60 to the surface of the skin and/or to an internal location (e.g., into the dermis). [175] System 10 can include implant 70 shown, which can comprise one or more implants which can be implanted in the patient such as to improve cosmesis of the patient, and/or to treat a disease and/or disorder of the patient. In some embodiments, a treatment performed by system 10 includes the implantation of one or more implants 70, such as to further improve cosmesis of the patient. In some embodiments, a treatment performed by system 10 is adjusted due to the presence of an existing implant (e.g., implant 70), and/or due to a future implantation of an implant (e.g., implant 70). [176] System 10 can include tissue collection assembly 600 shown (also referred to as “TCA 600” herein), which can comprise one or more assemblies configured to collect tissue which has been removed from the patient by treatment module 150. TCA 600 can comprise one or more containers for storing collected tissue. TCA 600 can comprise a vacuum pump and/or other low-pressure source, LPS 650 shown, such as to create a pressure differential which causes tissue extracted by treatment device 100 to be drawn into TCA 600.
Docket No. CYT-014-PCT [177] System 10 can include one or more functional elements, such as functional element 199 of treatment device 100, and/or functional element 599 of console 500, and/or functional element 99, each as shown. Functional elements 99, 199, and/or 599 can comprise one or more sensors and/or transducers, and/or an assembly that includes one or more sensors and/or transducers. Functional element 99, 199, and/or 599 can comprise a component (e.g., a sensor, or an assembly including a sensor) that is configured to collect patient data PD, such as diagnostic data DD and/or image data ID as described herein. In some embodiments, functional element 199 comprises at least one sensor, sensor 199a shown. In some embodiments, functional element 599 comprises at least one sensor, sensor 599a shown. [178] Functional elements 99, 199, and/or 599 can comprise one, two or more sensors configured to collect diagnostic data DD of a patient, and/or image data ID of a patient. [179] Functional elements 99, 199, and/or 599 can comprise a sensor (e.g., sensor 199a and/or 599a) that is configured to produce a signal related to tissue being captured in a coring element 155. In some embodiments, lack of detection of tissue being captured in a coring element 155 results in system 10 automatically adjusting one or more microcoring parameters (e.g., depth of penetration of element 155, velocity of element 155 advancement and/or retraction, and/or acceleration of element 155 advancement or retraction). In some embodiments, detection of tissue being captured in a coring element 155 is used to determine (e.g., automatically determine) a minimum depth of penetration of element 155. [180] Functional elements 99, 199, and/or 599 can comprise a wireless element, such as a wireless transmitter that can send and/or receive power and/or data wirelessly. In some embodiments, a functional element 99, 199, and/or 599 comprises a sensor and/or a transducer that receives power wirelessly, and/or transmits signals (e.g., recorded sensor signals) wirelessly. [181] Functional elements 99, 199, and/or 599 can comprise one or more sensors selected from the group consisting of: accelerometer; gravity-based sensor; strain gauge; acoustic sensor (e.g., a microphone or other acoustic sensor); electromagnetic sensor (e.g., a hall effect sensor); pressure sensor; vibration sensor; temperature sensor; vacuum sensor; GPS sensor; pH sensor; optical sensor; and combinations of these. [182] Functional elements 99, 199, and/or 599 can comprise a patient “physiologic sensor” comprising one, two or more sensors configured to measure a patient physiologic parameter such as: body temperature; heart rate; blood pressure; respiration rate; perspiration rate; blood gas level; blood glucose level; brain and/or other neural activity such as measured
Docket No. CYT-014-PCT by electroencephalogram (EEG), local field potential (LFP), and/or neuronal firing (e.g., single neuron firing activity); eye motion; EKG; and combinations of these. [183] Functional elements 99, 199, and/or 599 can comprise a patient “environment sensor” comprising one, two or more sensors configured to measure a patient “environment parameter” such as: room temperature; room humidity; room pressure; room light level; room ambient noise level; room barometric pressure; and combinations of these. [184] In some embodiments, functional elements 99, 199, and/or 599 comprise one or more sensors configured to measure a system 10 parameter, such as a system parameter selected from the group consisting of: temperature of at least a portion of a system 10 component; pressure and/or strain of a system 10 component; speed and/or acceleration of a system 10 component (e.g., speed and/or acceleration of a coring element 155 and/or other portion of treatment device 100); position and/or geometry of a system 10 component (e.g., position and/or geometry of a coring element 155 and/or other portion of treatment device 100); energy level; power level; and combinations of these. [185] In some embodiments, functional element 199 comprises one or more transducers configured to provide tactile feedback to an operator, such as tactile feedback configured to cause the operator to better hold and/or better position treatment device 100 (e.g., during microcoring). In these embodiments, functional element 199 can further comprise one or more accelerometers, and/or one or more other sensors configured to track movement and/or position of treatment device 100 (e.g., one or more sensors configured to provide one or more signals used by system 10 to track movement and/or position of treatment device 100). [186] In some embodiments, system 10 is configured to operate in a closed loop mode, in which one or more parameters of treatment device 100 are adjusted based on one or more recorded parameters, such as system parameters, patient physiologic parameters, and/or patient environment parameters, each as described herein. For example, algorithm 25 can analyze (e.g., continuously and/or intermittently analyze) one or more signals provided by a functional element 99, 199, and/or 599, and adjust the treatment performed by system 10 based on the analysis. [187] In some embodiments, functional elements 99, 199, and/or 599 comprise one or more transducers selected from the group consisting of: cooling element such as a Peltier element; heating element such as a Peltier element or a heat pump; vibrational transducer; light-producing element; a magnetic field-generating element; vacuum-generating element; and combinations of these.
Docket No. CYT-014-PCT [188] In some embodiments, functional elements 99, 199, and/or 599 comprise an assembly or other component configured to provide a vacuum to another component of system 10. For example, functional elements 99, 199, and/or 599 can comprise a tissue- engaging port configured to receive a vacuum (e.g., from console 500) and to stabilize tissue, capture tissue (e.g., draw tissue toward the port) and/or otherwise engage tissue, when the vacuum is applied to the port. Functional elements 99, 199, and/or 599 can comprise a source of vacuum, such as vacuum that can be applied to such a tissue-engaging port. [189] In some embodiments, functional elements 99, 199, and/or 599 comprise an adhesive, and/or an adhesive dispensing component, such as when an adhesive is used to temporarily (e.g., less than 1 day) and/or chronically (e.g., at least 1 week, 1 month, or 3 months) attach a component of system 10 to tissue of the patient, and/or to another component of system 10. [190] In some embodiments, functional elements 99, 199, and/or 599 comprise a cooling fluid or cooling component (e.g., a thermoelectric cooling element) and/or an assembly configured to provide cooling (e.g., provide cooling to a system 10 component). In some embodiments, system 10 is configured to provide cooling to tissue and/or to a system 10 component during delivery of a tissue treatment and/or diagnosis, such as to avoid damage to non-target tissue and/or to avoid degradation of a system 10 component. Alternatively or additionally, system 10 can comprise a functional element comprising an assembly configured to provide a cooling fluid (e.g., in a recirculating arrangement) to another system 10 component. [191] In some embodiments, functional elements 99, 199, and/or 599 comprise an assembly or other component configured to apply a force to tissue (e.g., a grasping component configured to place tissue in tension, and/or a pushing element configured to provide a compressive force to tissue), such as to apply a force (e.g., a tensioning and/or compressing force) to tissue (e.g., target tissue) while a microcoring procedure is being performed on target tissue by another component of system 10. [192] Functional elements 99, 199, and/or 599 can comprise an assembly configured to deliver agent 60 to the patient, as described herein. In some embodiments, agent 60 is delivered to the patient via one or more coring elements 155, where functional element 99, 199, and/or 599 comprises a pump or other fluid propulsion assembly that propels agent 60 through one or more conduits (e.g., fluid delivery tubes) such that agent 60 can be delivered into the patient (e.g., into the dermis of the patient) by one or more (e.g., all) coring elements
Docket No. CYT-014-PCT 155 during a microcoring or other procedure performed via injection of elements 155 into the patient. [193] Functional element 99 can comprise a cell phone, laptop, tablet, camera, and/or other operator-maintained device. In some embodiments, data collected during a treatment procedure performed by system 10 is provided by, stored, and/or analyzed by one of these devices. [194] Functional element 99 can comprise a patient diagnostic device, such as a device configured to gather patient data PD (e.g., diagnostic data DD and/or image data ID). [195] Treatment device 100 comprises various components such as conduits 101, nozzles 102, cable 103, and housing 110. These components can be of similar construction and arrangement to the similar components described in applicant’s co-pending United States Patent Application Serial Number 17/291,235, titled "Systems and Methods for Skin Treatment", May 4, 2021. [196] Coring elements 155 can comprise one, two or more hollow filaments, such as the coring elements 155 described herein in reference to Figs.3A-D. Each coring element 155 can comprise an elongate shaft (e.g., a hollow shaft), shaft 1551 shown, which can include a distal end. Each coring element 155 can comprise one or more projections, prong 1552 shown, that extend from the distal end of shaft 1551. [197] Spacer assembly 180 can comprise a housing and other components that are configured to properly position treatment module 150 relative to the patient’s skin being treated. Spacer assembly 180 can include one or more sensors, sensor 181 shown, which can be configured to detect proper engagement of spacer assembly 180 with the patient (e.g., proper pressure level detected). [198] Actuation assembly 120 can be configured to interface with treatment module 150 by performing a function selected from the group consisting of: control the motion of a treatment module 150 (e.g., translate treatment module 150 along one, two, or three axes); activate one or more components of treatment module 150 (e.g., advance and/or retract one or more coring elements 155 into and/or from tissue); rotate one or more components of treatment module 150 (e.g., rotate one or more coring elements 155 prior to, during, and/or after their insertion into tissue); vibrate one or more components of treatment module 150; and combinations of these. Actuation assembly 120 comprises actuator 121 shown. Actuator 121 and other components of actuation assembly 120 can be of similar construction and arrangement as the similar components described in applicant’s co-pending United States
Docket No. CYT-014-PCT Patent Application Serial Number 17/291,235, titled "Systems and Methods for Skin Treatment", May 4, 2021. [199] Console 500 can comprise user interface 510 as shown, which can comprise one or more user input and/or user output components, such as one, two or more components selected from the group consisting of: display; touch screen display; button; switch; foot switch; lever; membrane keypad; mouse, joystick; microphone; speaker; vibrational and/or other haptic transducer; light such as a light emitting diode; and combinations of these. Console 500 can comprise controller 520 as shown, which can include: one or more central processing units (CPUs), microprocessors and/or other microcontrollers, processor 521 shown; memory 522 shown (e.g., volatile or non-volatile memory); instructions 523 shown; signal processing and other electronic circuitry; oscillator circuitry such as voltage-controlled oscillator (VCO) circuitry; analog to digital circuitry; digital to analog circuitry; and/or other componentry configured to control or otherwise interface with one or more components of system 10. Controller 520 can comprise a power supply and/or energy storage component (e.g., a battery, a capacitor, and/or a power supply converted to receive “wall power” and convert it to an AC or DC voltage for use by system 10). Console 500 can further comprise drive module 550, and vacuum assembly 560, each as shown. Console 500 and its various components can be of similar construction and arrangement to those described in applicant’s co-pending United States Patent Application Serial Number 17/291,235, titled "Systems and Methods for Skin Treatment", May 4, 2021. [200] System 10 can include one or more accessory components, accessories 90 shown. Accessories 90 can include one or more accessory components, such as those described in reference to Fig.4 herein. [201] As described hereinabove, the term “microcoring treatment plan” or simply “treatment plan” can refer to a set of treatment variables (e.g., reciprocating motion parameters and/or other microcoring parameters) and/or a set of treatment locations (e.g., microcoring treatment locations) that can be created to define a future microcoring treatment to be performed. A “microcoring treatment plan” or a “treatment plan” can comprise a set of parameters that are used in treating target tissue of the patient using system 10. A treatment plan can include a set of treatment settings, such as one, two or more microcoring parameters (e.g., reciprocating motion parameters, target tissue parameters, patient parameters, and/or other microcoring parameters). A treatment plan can include a set of different skin and/or other tissue treatment, and/or other procedures (e.g., one, two or more microcoring procedures and/or other treatment procedures). A treatment plan can include a desired and/or
Docket No. CYT-014-PCT recommended order for performing a set of multiple tissue treatments or other procedures (e.g., where the treatment plan provides multiple procedures to be performed in a particular order, where in some instances sufficient efficacy is achieved when a subset of the procedures is performed). In some embodiments, system 10 is configured to automatically and/or semi-automatically (“automatically” herein) generate a treatment plan (e.g., one or more treatment plans made available to an operator of system 10). System 10 can generate a treatment plan using an algorithm, such as algorithm 25 described herein. A treatment plan can be developed by algorithm 25 using at least image data ID, such as by using image data ID comprising: ultrasound-based image data (e.g., Doppler data and/or other image data produced using ultrasound); CT-based image data; MRI-based image data; and/or X-ray- based image data (e.g., fluoroscopic data and/or other image data produced using X-ray). Alternatively or additionally, algorithm 25 can develop a proposed treatment plan based on parameters selected from the group consisting of: patient age; patient race; patient gender; patient skin type; patient skin condition; volume of target tissue to be treated; cellulite and/or fat content of target tissue; geometry of target tissue; tissue type, geometry and/or other characteristic of non-target tissue proximate the target tissue; and combinations of these. In some embodiments, a treatment plan includes a methodology to ensure treatment of target tissue, while avoiding damage to neighboring non-target tissue. In some embodiments, system 10 (e.g., via algorithm 25) is configured to produce a prediction of outcome (e.g., an estimation of likelihood of efficacy and/or an assessment of any risks) associated with one or more treatment plans. [202] As described herein, system 10 can comprise one or more algorithms, algorithm 25 shown. Algorithm 25 can comprise one or more algorithms that are performed by a processor (e.g., a processor of a system 10 component, such as processor 521 of controller 520). The processor can perform algorithm 25 using instructions (e.g., instructions 523 of controller 520 and/or instructions of another component of system 10), such as instructions that are stored in memory of that component (e.g., instructions 523 that are stored in memory 522 of controller 520). All or a portion of algorithm 25 can be integrated into one, two or more of various components of system 10, such as a server (e.g., server 20 described herein), console 500, treatment device 100, a patient device (e.g., patient device 300 described herein), a clinician device (e.g., clinician device 400 described herein), a vendor device (e.g., vendor device 700 described herein), imaging device 50, TCA 600, and/or functional element 99. Algorithm 25 can comprise one or more machine learning, neural network, and/or other artificial intelligence algorithms (“AI algorithm” herein).
Docket No. CYT-014-PCT [203] Algorithm 25 (e.g., an AI algorithm) can be configured to determine and/or modify one or more microcoring parameters, such as to effectively treat target tissue (e.g., improve cosmesis of the patient) and/or avoid damage to non-target tissue. For example, algorithm 25 can be configured to determine a volume of target tissue to be treated (e.g., treated with a microcoring procedure), such as to effectively enhance cosmesis of the patient and/or otherwise provide a therapeutic benefit to the patient, while avoiding or at least minimizing damage to non-target tissue. In these embodiments, algorithm 25 can be further configured to determine and/or modify one or more microcoring parameters (e.g., at least based on the determined volume), such as to effectively treat the target tissue volume determined, while avoiding damage to non-target tissue, as described hereinabove. [204] Algorithm 25 (e.g., an AI algorithm) can be configured to perform a “microcoring analysis” comprising using an analysis of one or more types of information by algorithm 25 to assess the level of microcoring (e.g., the current level of microcoring) of target tissue. The results of this analysis can be used by system 10 to perform microcoring in a closed loop mode. Microcoring data produced in the microcoring analysis can be stored as image data ID (e.g., and correlated with one or more tissue locations). In some embodiments, system 10 (e.g., treatment device 100 and/or imaging device 50) delivers and/or receives energy (e.g., light energy and/or ultrasound energy or other imaging-capable energy) to and/or from tissue, and algorithm 25 performs a microcoring analysis based on the delivered and/or received energy. [205] Algorithm 25 (e.g., an AI algorithm) can be configured to adjust tissue treatment parameters (e.g., microcoring parameters) based on sensor signals, such as when sensor 199a provides feedback to algorithm 25 regarding a microcoring procedure. [206] In some embodiments, algorithm 25 (e.g., an AI algorithm) is configured to perform an analysis on patient data PD (e.g., patient use data from a single patient, or a group of patients upon which system 10 has performed a treatment procedure), such as to modify a future treatment provided by system 10. [207] In some embodiments, algorithm 25 (e.g., an AI algorithm) is configured to provide a treatment plan, such as when algorithm 25 performs analysis on patient data PD comprising data collected during treatment of the patient with system 10 in a previous treatment procedure, and/or based on patient data PD collected from use of system 10 on multiple patients (e.g., a large number of patients treated with system 10). [208] System 10 can include network 80 as shown, which can comprise one or more computer networks such as the Internet, a local area network, cellular network, and/or other
Docket No. CYT-014-PCT data sharing, storage, and/or transmitting platform. In some embodiments, patient data PD, and/or other data collected during the use of system 10 is transmitted from one location to another location over network 80. In some embodiments, one or more central data storage areas are used to store the data, such as when an algorithm 25 analyzes the data to provide a treatment plan and/or provide system 10 parameters for a future treatment of one or more patients. [209] Treatment device 100 and/or another component of system 10 can be configured to perform a treatment (e.g., a microcoring treatment) in a “closed loop” mode (i.e. a closed loop mode of microcoring and/or other closed loop mode of operation), such as when one or more sensors of system 10 (e.g., a sensor-based functional element 99, 199, and/or 599), provide patient and/or system information that is used to continuously and/or intermittently adjust the treatment being delivered by treatment device 100 (e.g., adjust the microcoring parameters and/or other parameters of the treatment). For example, microcoring can be adjusted in a closed loop mode based on a system 10 parameter and/or based on a patient parameter (e.g., a patient physiologic parameter, patient anatomical parameter, and/or a patient environment parameter, each as described herein). Microcoring by treatment device 100 can be adjusted based on image data ID described herein, such as to redirect and/or otherwise adjust microcoring (e.g., due to detected patient motion and/or undesired treatment device 100 motion) and/or to change one or more microcoring parameters (e.g., as determined by algorithm 25 using image data ID or other data). In some embodiments, image data ID is used to determine when a treatment (e.g., a microcoring amount) is sufficient, such as when algorithm 25 analyzes image data ID to confirm sufficient change in tissue characteristics have occurred. [210] As described herein, system 10 can be configured to perform a series of skin and/or other tissue treatment procedures on a patient, such as a patient desiring improved cosmesis of the face or other body location, as described herein. In some embodiments, system 10 is configured to be used to: perform a first procedure and a second procedure, in which the two procedures are performed at least 24 hours apart. The first procedure can include microcoring, the second procedure can include microcoring, or both can include microcoring. In some embodiments, the first procedure does not include microcoring, while the second procedure does include microcoring. In some embodiments, two, three, four, or more microcoring procedures of the present inventive concepts are performed, such as over a period of months and/or years. In some embodiments, the treatment plan for a subsequent
Docket No. CYT-014-PCT procedure using system 10 is based on the data collected and/or results of one or more previous treatment procedures performed using system 10. [211] System 10 can be configured to perform a treatment on a patient (e.g., a patient desiring improved cosmesis of the face or other body location) that includes the performance of multiple, sequential treatment plans, such as a sequence of treatment plans that each may use one, two or more components of system 10 (e.g., one, two or more of treatment devices 100) that are used to perform one or more diagnostic procedures, and/or one or more therapeutic procedures. Performance of an “initial treatment plan” performed using system 10, can be configured based on current physiologic state (e.g., current undesired state of tissue) of the patient, as well as any previous treatments performed (e.g., using system 10 or otherwise). Each “subsequent treatment plan”, can also be based on the current physiologic state, as well as all previous treatments performed, as described herein. [212] In some embodiments, the one or more coring elements 155 (e.g., three coring elements 155) comprise a dimension selected from the group consisting of: an outer diameter of no more than 0.050in, or no more than 0.040in, such as approximately 0.028in; an inner diameter of no more than 0.030in, or no more than 0.025in, such as approximately 0.016in; a core length of at least 0.5mm and/or no more than 5.0mm; a penetration depth of no more than 6.0mm; a cutting depth of no more than 5.0mm; and combinations of these. [213] In some embodiments, one or more coring elements 155 comprise a double- beveled needle geometry (e.g., as shown in Figs.3A-D), such as to minimize effective insertion depth and/or resist wear during use. [214] In some embodiments, system 10 is configured to precisely control insertion speed of the one or more coring elements 155 (e.g., simultaneous insertion of all of coring elements 155). In these embodiments, the dwell time can comprise a time of no more than 60msec, such as no more than 45msec, no more than 30msec, and/or no more than 20msec. System 10 (e.g., console 500 and/or treatment device 100) can comprise a proportional integral derivative (PID) controller that provides closed loop control of coring element 155 advancement and position that results in accurate core depth, such as while minimizing impact forces on the patient’s skin (e.g., thus improving healing response and core hole precision). [215] In some embodiments, multiple coring elements 155 are positioned in an array (e.g., a linear arrangement of three or four elements 155) in which the coring elements 155 are separated by a distance of at least 0.2mm, such as at least 0.5mm, at least 1.0mm, at least 2.0mm, and/or approximately 3.33mm.
Docket No. CYT-014-PCT [216] System 10 can include tissue collection assembly 600 for clearing tissue cores captured by coring elements 155. In some embodiments, LPS 650 comprises a single source of low pressure (e.g., vacuum) that provides multiple (e.g., two) functions. System 10 can be configured to control the flow rate (e.g., the pressure) proximate the coring elements 155, such as to remove tissue cores without impacting low pressure applied to spacer assembly 180 (e.g., spacer assembly 180 using suction to stabilize treatment module 150 relative to the patient’s skin). The flow channels into which the tissue cores are extracted can include a funnel portion that increases the flow velocity at locations where the tissue is extracted from the back ends of the coring elements 155. [217] Treatment device 100 can comprise spacer assembly 180, which can provide a stabilizing force to treatment device 100 during use, as described herein. For example, spacer assembly 180 can utilize a suction force that allows effective treatment of target tissue areas comprising various surface contours. System 10 can include an automated pinch valve in line with vacuum conduits provided to spacer assembly 180, such as to provide enhanced stabilization of treatment module 150 with the patient’s skin between patterns of deployment of one or more coring elements 155. For example, the pinch valve can be activated to allow easy repositioning of treatment module 150 (e.g., and spacer assembly 180) at the end of a pattern of microcoring, such as to improve ease and speed of a treatment. [218] Treatment device 100 can comprise a “treatment window” that is sized to accommodate various ranges of suction force to be applied. In some embodiments, spacer assembly 180 provides a treatment window of at least 100mm2, such as no more than 2,000mm2, such as approximately 640mm2, such as to provide a nominal holding force of treatment module 150 (e.g., spacer assembly 180) of at least 10.0N, such as at least 18.0N, such as approximately 28.5N with the patient’s skin. [219] System 10 can be configured to detect (e.g., and quantify) deceleration of coring elements 155, such as to minimize damage to the coring elements 155 and/or to detect damage to at least one coring element 155. [220] System 10 can include various features that enhance positioning accuracy (e.g., during deployment) of coring elements 155, such as positioning accuracy in X and Y directions, and/or positioning accuracy in the Z dimension (e.g., insertion direction). Such features include but are not limited to: 1:1 gearing and/or direct drive in actuation assembly 120; sensor detection of position (e.g., hall sensors and/or optical sensors such as optical encoders); linear bearings (e.g., that minimize undesired motion and/or creep from a desired position); and combinations of these.
Docket No. CYT-014-PCT [221] System 10 can be configured to provide variable patterns for microcoring (e.g., varied microcoring density), such as to achieve a skin removal percentage (also referred to as “areal fraction”) of no more than 20%, and/or no less than 0.5%, such as at least 1%, and/or at most 10% (e.g., between 1% and 10%). [222] Actuation assembly 120 can comprise one or more actuators (e.g., solenoids) that are configured to precisely control movement of one or more coring elements 155 such as to achieve variable depth control within 0.8mm, such as within 0.5mm, while accommodating variability in skin thickness, skin toughness, and/or other varying skin parameters. [223] System 10 can comprise a calibration routine such as to store calibration information created during manufacturing of one or more components of system 10, and/or information collected at a site (e.g., prior to, during, and/or after use of system 10). Calibration data can be stored in a treatment module 150, actuation assembly 120, and/or other component of treatment device 100. System 10 can be configured to improve accuracy of needle deployment (e.g., in the Z direction), based on the calibration data (e.g., to accommodate variability in manufacturing processes). [224] Coring elements 155 can comprise a bevel angle of no more than 30 degrees, such as no more than 25 degrees, and/or no more than 20 degrees, such as to improve healing and/or minimize scarring of the patient. [225] System 10 can be configured to control the speed and/or frequency (e.g., repetition rate) of the deployment of the coring elements 155 into the patient’s skin, such as to deploy the elements 155 (e.g., three elements 155 in unison) at a rate of at least 1Hz, or 3Hz, or approximately 8Hz. Alternatively or additionally, system 10 can be configured to deploy the elements 155 (e.g., three elements 155 in unison) at a rate of no more than 30Hz, such as no more than 20Hz, such as approximately 8Hz. [226] Applicant has conducted various studies using the systems, devices, methods, and other technologies of the present inventive concepts, such as system 10 and its components as described herein. Applicant has conducted studies using the systems of the present inventive concepts in mammalian subjects, including multiple studies in porcine models as well as human patients. Results of these studies are described in applicant’s co-pending United States Patent Application Serial Number 18/560,784, titled "Skin Treatment Systems and Methods", filed November 14, 2023. [227] System 10 can be configured to remove skin via microcoring, such as without use of thermal energy (e.g., avoiding damage to cells from heating) during the microcoring procedure. Energy-based devices such as fractional laser and radiofrequency ablation lead to
Docket No. CYT-014-PCT epidermal and dermal cell necrosis from thermal injury that may inhibit rapid wound closure, an adverse effect that can be avoided via use of system 10. Although fractional lasers and radiofrequency devices have shown acceptable results in rejuvenation of skin, data on skin tightening is inconclusive. It is suspected that coagulation necrosis of the cells surrounding fractional laser cores prevent early wound closure and therefore limit reduction of skin surface area and skin tightening. System 10 avoids coagulation necrosis and can achieve both early wound closure, and enhanced skin tightening, as described herein. The coring elements 155 and other components of system 10 provide numerous benefits including limited side effects, and fast (e.g., expedited) patient recovery. By removing tissue, significant skin tightening can be achieved, as demonstrated by data gained in skin and/or other tissue treatment procedures performed on human subjects. [228] System 10 can be configured to both tighten skin and reduce skin wrinkles and/or folds of the patient’s skin. Use of system 10 in human patients has achieved skin tightening as well as reduction in skin wrinkles and/or folds, via removal of skin without the use of thermal energy, while also reducing (e.g., preventing or resulting in minimal) scar formation. [229] In some embodiments, system 10 comprises multiple microcoring subsystems, such as microcoring subsystems 11a, 11b, 11c through 11n as shown. Each microcoring subsystem 11 can be configured as described in reference to Fig.4 and otherwise herein. [230] Fig.2 illustrates a coring element 155 being safely introduced into the skin, such as to subsequently be withdrawn to remove a microcore of tissue, such that the remaining tissue heals with no scarring or at most minimal scarring. The treatment provided by system 10 also provides near-immediate closure along the relaxed skin tension lines (RSTLs), with no thermal energy. [231] Referring now to Figs.3A-D, various views of a coring element are illustrated, consistent with the present inventive concepts. Typical dimensions of a coring element 155 are shown. In some embodiments, coring element 155 comprises a penetrating portion with an outer diameter of at least 0.0203” and/or an outer diameter of no more than 0.050”. In some embodiments, coring element 155 comprises a penetrating portion with an inner diameter of at least 0.0103” and/or an inner diameter of no more than 0.0207”. [232] Referring now to Fig.4, a block diagram of a tissue treatment system is illustrated, consistent with the present inventive concepts. As shown, system 10 of Fig.4 includes treatment device 100, console 500, tissue collection assembly 600, and other components as shown, each of which can be of similar construction and arrangement to the similar components described in reference to system 10 of Fig.1 described herein.
Docket No. CYT-014-PCT [233] Treatment device 100 can be configured as a handheld device, comprising a “handpiece” geometry. [234] Console 500 can comprise user interface 510 as shown. In some embodiments, at least a portion of user interface 510 is integral to treatment device 100. User interface 510 can be configured to allow a user (e.g., a technician) to set one or more microcoring parameters, such as depth of penetration of coring elements 155, density of coring (e.g., density of coring created by an array of one, two, three or more elements 155 of treatment module 150), and/or other coring and/or system 10 parameters. In some embodiments, system 10, via user interface 510, is configured to provide an automated presentation of: pre- treatment setup steps of system 10; intra-treatment use of system 10; and/or post-treatment steps of system 10. [235] Treatment device 100 can include one or more treatment modules 150, which can include a single coring element 155 or multiple coring elements 155 (e.g., three coring elements 155). In some embodiments, treatment device 100 includes a kit 1500 of multiple treatment modules 150, such as a kit including at least one treatment module 150a each with a single coring element 155, and at least one treatment module 150b each with multiple (e.g., three) coring elements 155. For example, a treatment module 150a with a single coring element 155 can be used to perform microcoring in one or more “hard to reach areas”, while treatment module 150b can be used to perform microcoring in skin surface areas that are larger (e.g., to reduce treatment time than that achievable via a treatment module 150a with a single coring element 155). Treatment module 150b can comprise an assembly of multiple (e.g., three) coring elements 155 that are positioned at least 1mm, at least 2mm, at least 3mm, and/or approximately 3.33mm apart (e.g., to reduce likelihood of skin “tenting” and/or to reduce slicing of skin). In some embodiments, treatment module 150b can comprise an assembly of multiple (e.g., three) coring elements 155 that are positioned no more than 7mm apart, such as no more than 6mm apart, no more than 5mm apart, and/or no more than 4mm apart. [236] In some embodiments, treatment module 150b comprises an assembly of multiple (e.g., three) coring elements 155, where each element 155 comprises opposing lateral sides that terminate at the distal end of each element 155 in one or more sharpened edges that each define a cutting axis. In some embodiments, the axes of the cutting edges of multiple (e.g., three) coring elements 155 are arranged in a non-linear arrangement, such as to prevent slicing and/or tearing of skin positioned between coring elements 155 during microcoring
Docket No. CYT-014-PCT (e.g., slicing and/or tearing that might result from multiple linearly aligned cutting edges of relatively close proximity being inserted through the skin simultaneously). [237] Treatment module 150 can comprise a single assembly that is attached to the remaining portion of treatment device 100, and it can include one or more mechanisms to prevent undesired movement of microcoring elements 155 when not attached. [238] Treatment device 100 can include actuation assembly 120 which can include one or more actuators, such as x-actuator 121x, y-actuator 121y, and/or z-actuator 121z as shown. In some embodiments, actuation assembly 120 includes x-actuator 121x and y-actuator 121y for positioning the coring elements 155 relative to one or more locations on the patient’s skin, and z-actuator 121z is configured to advance the elements 155 into the skin, such as is described in detail hereinbelow. This x-y positioning, and z-advancement can be repeated multiple times until a desired microcoring pattern is achieved. Actuators 121 (e.g., x-actuator 121x and y-actuator 121y) can comprise motors, such as brushless DC motors, as well as a fine-pitched lead screw (e.g., a lead screw with a M3C0.5-6g thread). The lead screw can comprise a brass or other metal lead screw with a PEEK or other plastic projection that rides on the screw threads. Actuators 121 (e.g., x-actuator 121x and y-actuator 121y) can comprise a motor with at least a 3:1 or 4:1 gear ratio. Actuators 121 can comprise one or more position sensors (e.g., functional elements 199a configured as position sensors), such as hall effect sensors. In some embodiments, x-actuator 121x and/or y-actuator 121y include an optical gate-based position sensor. In some embodiments, z-actuator 121z comprises a position sensor (e.g., a functional element 199a configured as a position sensor), such as a linear magnetic and/or optical encoder configured to determine the change in position of a translating component of actuator 121z (e.g., determine the change in position of the translating component of actuator 121z, such as to determine the acceleration, speed, and/or absolute position of advancement and/or retraction of coring elements 155 by actuator 121z). In some embodiments, z-actuator 121z comprises a position sensor that includes or is integral to a linear bearing, such as to ensure unimpeded motion of z-actuator 121z. [239] System 10 can be configured to perform a microcoring of tissue by the clinician or other operator positioning a skin contacting surface (e.g., a frame as described herein) of treatment device 100 at a first tissue surface location. Activation of coring (e.g., via a footswitch or other control of system 10) is initiated by the operator, and the following sequence of events occur: (1) treatment module 150 (e.g., including one or more coring elements 155, such as three coring elements 155) is advanced into tissue (e.g., via z-actuator 121z to a target depth); (2) treatment module 150 is withdrawn from the tissue (e.g., via z-
Docket No. CYT-014-PCT actuator 121z); and (3) treatment module 150 is repositioned to a new location (e.g., via x- actuator 121x and/or y-actuator 121y). Steps 1 thru 3 can be performed a single time, or multiple times, such as at least 3, 8, 12, 17, and/or 20 times (e.g., with a three coring element 155 assembly), in order to perform a “treatment event”. After a first treatment event is performed, one or more subsequent treatment events can be initiated. In each event, the operator positions the skin contacting surface (e.g., a frame as described herein) at a desired (e.g., new) tissue location, and one or more series of Steps 1 thru 3 are repeated. [240] In some embodiments, a switch (e.g., a footswitch) and/or other control that is activated by an operator to initiate a treatment event, must remain activated (e.g., a footswitch must continue to be depressed) in order for the treatment event to continue to completion (e.g., of the one or more series of Steps 1 thru 3 that are repeated). If the control is not maintained in an active state (e.g., a footswitch pedal is released), system 10 can be configured in the following arrangement: if Step 1 or Step 2 is in process, the treatment procedure continues thru completion of Step 2 (i.e. completion of needle withdrawal), and an additional coring element 155 advancement of Step 1 is prevented; otherwise (e.g., if Step 3 is in process), the treatment procedure stops. This configuration provides a safe mode of operation as well as allowing an operator to treat a portion of a proposed treatment area of a treatment event. [241] System 10 can include a limit on depth of travel of actuator 121z (e.g., limit depth of travel of a translating component of actuator 121z that translates along the z-axis), such as to limit depth of penetration of one or more coring elements 155 into skin (e.g., such as to avoid contact of a coring element 155 with a nerve, blood vessel, and/or bone). In some embodiments, this depth of penetration is input by an operator (e.g., input into user interface 510), such as a depth of 3mm, 4mm, and/or 5mm of penetration into the patient’s skin. In some embodiments, a titration or other iterative adjustment procedure is performed by an operator, in which depth of penetration is adjusted, such as to increase depth of penetration to achieve sufficient coring, and/or a decrease in depth of penetration (e.g., when treating an area in which element 155 contact with bone might otherwise result). System 10 can be configured to decelerate actuator 121z as the one or more microcoring elements 155 are approaching a target depth. [242] Actuator 121z can be controlled by one or more algorithms of system 10 (e.g., algorithm 25) via one or more sets of instructions. Ranges of positions of a translating portion of actuator 121z range from a -zmax to zmax, with a rise time tr. The translating component of actuator 121z has a velocity, v, and a maximum velocity vmax, and an
Docket No. CYT-014-PCT acceleration, a. The acceleration a of the translating component of actuator 121z can be controlled to approximate a smooth continuous function. The translating component of actuator 121z can have a zmax equal to approximately 0.007m (0.7cm), and vmax can be equal to approximately 1.0m/sec. The translating component of actuator 121z can have a velocity function as follows:
[243] Treatment device 100 can be void of any surface, projection, and/or other mechanical stop that is contacted by treatment module 150 during advancement of coring elements 155 in a microcoring procedure (e.g., no mechanical stop is used to limit advancement of coring elements 155 during a microcoring procedure). Avoidance of such a mechanical stop can provide numerous advantages, such as avoiding the vibration that occurs when a moving assembly makes contact with a mechanical stop (e.g., a vibration that can cause a degradation of tissue cores removed during a microcoring procedure). [244] Treatment device 100 can comprise one or more sensors, such as sensor 199a shown. Console 500 can comprise one or more sensors, such as sensor 599a shown. Sensor 199a and/or 599a can comprise one or more sensors. Sensor 199a and/or 599a can comprise a pressure sensor, such as a pressure sensor configured to monitor a pressure level (e.g., a vacuum pressure level) of one or more conduits or other cavity portions of system 10. Sensor 199a and/or 599a can comprise one, two, or more sensors configured to monitor (e.g., constantly monitor during use) the position (e.g., the x, y, and/or z position) of actuation assembly 120 (e.g., monitor the position of an actuator 121). Sensor 199a and/or 599a can comprise one, two or more sensors configured to monitor the position of a component of system 10, such as the position of a component of an actuator 121. For example, sensor 199a and/or 599a can comprise an encoder (e.g., a magnetic and/or optical encoder), such as an encoder that monitors the position of a component of actuator 121. In some embodiments,
Docket No. CYT-014-PCT sensor 199a and/or 599a comprises a position sensor (e.g., an encoder) which monitors a position of a component with a resolution of 0.5mm or less. For example, sensor 199a and/or 599a can comprise one or more position sensors (e.g., one or more encoders) that monitor the one or more positions of actuator 121x and/or 121y with a greater precision than 60μm (e.g., a resolution of 60μm or less), such as greater precision than 40μm, such as a resolution of approximately 20μm. Alternatively or additionally sensor 199a and/or 599a can comprise one or more position sensors (e.g., one or more encoders) that monitor one or more positions of actuator 121z with a greater precision than 5μm (e.g., a resolution of 5μm or less), such as a greater precision than 4μm, 3μm, and/or 2μm, such as a resolution of approximately 1μm. [245] In some embodiments, system 10 is configured to constantly (e.g., always) determine and/or otherwise know the position of treatment module 150 and/or its coring elements 155 (e.g., constantly determine and/or otherwise know the x, y, and/or z positions of each element 155 during use). Alternatively or additionally, sensor 199a and/or 599a can comprise one, two, or more sensors configured to monitor (e.g., constantly monitor during use) the speed and/or the acceleration of actuation assembly 120 (e.g., monitor the speed and/or acceleration of an actuator 121). System 10 can comprise one or more position, speed, and/or acceleration limits (e.g., threshold above or below which operation is prevented or at least requires additional attention from an operator). System 10 can include a set of position, speed, and/or acceleration thresholds, such as for any actuator 121. Detection of any of these parameters outside of an expected range can result in system 10 entering a warning state, such as a state in which further operation is limited (e.g., microcoring is prevented) until further action is taken. For example, system 10 can be configured to alarm if one of the following conditions are detected (e.g., as determined by signals provided by sensor 199a and/or 599a): intended depth of penetration of a microcoring element 155 not achieved; velocity profile of a microcoring element 155 motion outside of an intended window (e.g., element 155 does not reach an intended location within a time window); a microcoring element 155 at an undesired position; acceleration of a microcoring element 155 is above a threshold ; and combinations of these. Sensor 199a and/or 599a can comprise one or more sensors configured to monitor current, such as current applied to an actuator 121 (e.g., x- actuator 121x, y-actuator 121y, and/or z-actuator 121z). System 10 can be configured to monitor current value of current, peak current, and/or amount of current over time. Current above a threshold can correlate to an actuator 121 having to exert an undesired amount of force, and/or an actuator 121 being in a “stuck” position. Sensor 199a and/or 599a can comprise one or more sensors configured to detect a “locked” or “unlocked” status of
Docket No. CYT-014-PCT treatment module 150, such as to prevent use (e.g., prevent microcoring) if treatment module 150 is not properly positioned in treatment device 100. [246] System 10 can be configured to monitor repeated use of treatment module 150, such as when an upper limit of uses is applied by system 10. For example, each treatment module 150 can comprise a unique identifier (e.g., an RFID or other identifier as described herein), and system 10 can keep track of uses of treatment module 150 such as to prevent repeated use above a threshold. [247] In some embodiments, system 10 is configured to monitor deceleration of actuator 121z, such as to reduce the likelihood of damage to one or more coring elements 155. Sensor 199a and/or 599a can comprise one or more sensors configured to detect a deceleration “fault”, in other words a detected level of deceleration that is outside of an expected range, and/or has repeatedly transitioned above one or more deceleration thresholds. A deceleration fault can indicate damage (e.g., hooked end, bent shaft, and the like) to one or more microcoring elements 155 may have occurred (e.g., due to hitting bone or other hard surface during advancement). System 10 can be configured to prevent further use until inspection by an operator is performed (e.g., and treatment module 150 is replaced or confirmation of no damage is provided by the operator). In some embodiments, system 10 is configured to monitor the deceleration of a translating component of actuator 121z (e.g., the component causing coring elements 155 to advance into and retract from tissue), and if the monitored deceleration exceeds (e.g., at any time) a maximum threshold, DMAX, cause system 10 to enter an alarm state in which the operator is required to perform an action, such as: replacement of all or a portion of treatment module 150; inspection of treatment device 100 and/or another component of system 10; and/or performance of a safety and/or efficacy related task. In some embodiments, DMAX comprises a deceleration level of no more than 75g, such as no more than 60g, such as a deceleration limit of approximately 50g. In some embodiments, system 10 has multiple deceleration thresholds, such as a DMAX (e.g., as described hereinabove), as well as one, two or more other, lower thresholds, such as a D1, and/or a D2 deceleration threshold, such as when D2 is greater than D1. System 10 (e.g., algorithm 25) can be configured to record the number of times actuator 121z exceeds either or both thresholds, and to enter an alarm state (e.g., a state in which use of system 10 is stopped until further action is performed as described hereinabove), and/or to enter an alert state (e.g., a state in which use of system 10 can continue, but the operator is notified of the exceeding of the threshold). In some embodiments, D1 comprises a threshold of no more than 40g, such as no more than 35g, or approximately 32g, and system 10 enters an alert state
Docket No. CYT-014-PCT if deceleration of actuator 121z exceeds D1. In some embodiments, system 10 enters an alert and/or an alarm state (e.g., as described hereinabove) if a difference in deceleration (e.g., between two or more advancements of actuator 121z) exceeds a threshold (e.g., one advancement has a deceleration that exceeds a previous advancement by a threshold level). In some embodiments, monitoring of deceleration of actuator 121z is used to automatically adjust the depth of penetration (e.g., depth of advancement) of element 155. [248] In some embodiments, system 10 includes one or more sensors configured to monitor for inadequate communication (e.g., loss of communication) between two or more components of system 10 (e.g., between treatment device 100 and console 500). [249] System 10 (e.g., console 500 and/or treatment device 100) can be configured to operate in a closed loop mode, such as via a PID or other control module. In some embodiments, system 10 is configured to adjust (e.g., automatically adjust) the depth of penetration of coring elements 155 based on deceleration of actuator 121z (e.g., such as when system 10 records, stores, and/or otherwise monitors the deceleration of actuator 121z). [250] Accessories 90 can include various accessory components, such as a power cord (e.g., to attach to wall power), one or more filters, suction tubing, and/or other accessory components. Accessories 90 can include a footswitch, such as an operator-controlled footswitch configured to initiate and/or stop microcoring or other function of system 10. [251] Functional element 599 of console 500 and/or functional element 199 of treatment device 100 can comprise a data transmission module, such as a cellular or other wireless transceiver, and/or a wired connection transceiver. System 10 can be configured to transmit system 10 use and/or other recorded information (e.g., data logs) to a remote site (e.g., the cloud, the system 10 manufacturer’s location, a data collection service, and the like) via the transceiver, such as to collect, process, and/or analyze data collected by one or more systems 10 that are in use at one or more settings in which a system 10 is used. [252] In some embodiments, and as described herein, system 10 comprises a treatment module 150 comprising one or more coring elements 155, and an actuation assembly 120 that is operably attached to treatment module 150. Actuation assembly 120 and one or more other components of system 10 can be configured to perform a microcoring procedure comprising the treatment module 150 translating in a series of “reciprocating motions”, each reciprocating motion comprising each coring element 155 being inserted into and withdrawn from tissue of the patient, such as to provide a cosmetic effect to the patient. [253] In some embodiments, the series of reciprocating motions comprises at least one reciprocating motion. The series of reciprocating motions can comprise at least two
Docket No. CYT-014-PCT reciprocating motions, such as multiple reciprocating motions that are performed in a similar or dissimilar fashion (e.g., with similar and/or dissimilar levels of reciprocating motion parameters, respectively). [254] In some embodiments, actuation assembly 120 is further configured to translate the treatment module 150 in one or more directions relative to a surface of skin tissue of the patient, such as in two orthogonal directions (e.g., in an x-y positioning arrangement as described herein, in which after each x-y positioning, the one or more coring elements are advanced and retracted along a z-axis in a reciprocating motion). [255] In some embodiments, system 10 is configured to perform the series of reciprocating motions based on one, two, or more parameters associated with the reciprocating motion. These one, two, or more “reciprocating motion parameters” can comprise parameters selected from the group consisting of: insertion speed; insertion acceleration; insertion rise time; insertion dwell time; insertion fall time; insertion force; withdrawal speed; withdrawal acceleration; withdrawal force; core diameter; depth of insertion; microcoring density; microcoring pattern; lateral movement speed; lateral movement direction; lateral movement vector; lateral movement height; microcoring location; microcoring location tolerance; deceleration threshold; undershoot threshold; overshoot threshold; vacuum actuation release delay; vacuum release duration; and combinations thereof. System 10 can comprise reciprocating motion parameters, and at least one reciprocating motion parameter can be adjustable by an operator. In some embodiments, at least one reciprocating motion parameter can be automatically adjusted by system 10. [256] In some embodiments, system 10 is configured to assess coring depth. Assessment can comprise an assessment of the depth of a previously captured core, and/or a core to potentially be captured in the future. System 10 can comprise a sensor (e.g., one, two, or more sensor-based functional elements 99 and/or 199) that can be configured to produce a signal, and system 10 can be configured to assess the coring depth based on the sensor signal. The sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof. As described herein, system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) an algorithm, algorithm 25 shown, and algorithm 25 can be configured to perform the coring
Docket No. CYT-014-PCT depth assessment. As described herein, algorithm 25 can comprise one or more machine learning, neural network, and/or other artificial intelligence algorithms (“AI algorithm” herein). The assessment can comprise providing an optimized depth for coring. System 10 can be configured to automatically adjust the coring depth based on the assessment. Alternatively or additionally, system 10 can be configured to provide coring depth feedback to the operator based on the assessment. The coring depth feedback can comprise a suggested depth for coring. The feedback can comprise a “too deep” warning when the assessment indicates depth of coring has been above a threshold. [257] In some embodiments, system 10 is configured to detect whether a core has been captured in at least a first coring element of the one or more coring elements 155. System 10 can be configured to detect whether a core has been captured in each of the one or more coring elements 155. System 10 can comprise a sensor (e.g., one, two, or more sensor- based functional elements 99 and/or 199) that can be configured to produce a signal, and system 10 can be configured to detect whether a core has been captured based on the sensor signal. The sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof. As described herein, system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the determination of whether the core has been captured. System 10 can comprise one or more reciprocating motion parameters, and algorithm 25 can be further configured to correlate the likelihood of future core captures to a reciprocating motion parameter. In these embodiments, algorithm 25 can comprise an AI-based algorithm, as described herein. System 10 can be configured to automatically adjust a reciprocating motion parameter if a sufficient core cannot be detected as having been captured. The one, two, or more reciprocating motion parameters that are adjusted can comprise parameters selected from the group consisting of: insertion speed; insertion acceleration; insertion rise time; insertion dwell time; insertion fall time; insertion force; withdrawal speed; withdrawal acceleration; withdrawal force; core diameter; depth of insertion; microcoring density; microcoring pattern; lateral movement speed; lateral movement direction; lateral movement vector; lateral movement height; microcoring location; microcoring location tolerance; deceleration threshold; undershoot threshold;
Docket No. CYT-014-PCT overshoot threshold; vacuum actuation release delay; vacuum release duration; and combinations thereof. [258] In some embodiments, system 10 is configured to assess the quality of a captured core. System 10 can comprise a sensor (e.g., one, two, or more sensor-based functional elements 99 and/or 199) that can be configured to produce a signal, and system 10 can be configured to assess the quality of the captured core based on the sensor signal. The sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof. System 10 can comprise a handpiece that includes actuation assembly 120, and the sensor can be positioned in the handpiece. Alternatively, system 10 can include sensing device 40 as shown, such as a sensing device that does not include actuation assembly 120, and where the sensor (e.g., functional element 99) configured to detect the captured core is positioned in sensing device 40. As described herein, system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the assessment of the core quality. In these embodiments, algorithm 25 can comprise an AI-based algorithm, as described herein. Algorithm 25 can be configured to provide a coring score representing the quality of the captured core (e.g., a coring score provided to an operator of system 10, such as via a display of console 500, display 511 shown, or other display, speaker, and/or other output component of system 10). [259] In some embodiments, system 10 is configured to identify the tissue type and/or a tissue property of tissue of a captured core, tissue of a target tissue location, or both. System 10 can comprise a sensor (e.g., one, two, or more sensor-based functional elements 99 and/or 199) that can be configured to produce a signal, and system 10 can be configured to identify the tissue type and/or tissue property based on the sensor signal. The sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof. As described herein, system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can
Docket No. CYT-014-PCT store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the identification of the tissue type and/or tissue property. In these embodiments, algorithm 25 can comprise an AI-based algorithm, as described herein. System 10 can be configured to identify one, two, or more tissue types selected from the group consisting of: skin tissue; fat tissue; muscle tissue; blood vessel wall tissue; blood; scar tissue; and combinations thereof. System 10 can comprise one or more reciprocating motion parameters, and system 10 can be configured to adjust a reciprocating motion parameter based on the identified tissue type and/or tissue property. The one, two, or more reciprocating motion parameters that are adjusted can comprise parameters selected from the group consisting of: insertion speed; insertion acceleration; insertion rise time; insertion dwell time; insertion fall time; insertion force; withdrawal speed; withdrawal acceleration; withdrawal force; core diameter; depth of insertion; microcoring density; microcoring pattern; lateral movement speed; lateral movement direction; lateral movement vector; lateral movement height; microcoring location; microcoring location tolerance; deceleration threshold; undershoot threshold; overshoot threshold; vacuum actuation release delay; vacuum release duration; and combinations thereof. System 10 can be configured to reduce insertion depth if the identified tissue type comprises fat tissue. System 10 can be configured to increase insertion force if the identified tissue type comprises scar tissue. System 10 can be configured to modify a reciprocating motion parameter if an undesired and/or unexpected tissue type and/or tissue property is identified. The one, two, or more reciprocating motion parameters that are adjusted can comprise parameters selected from the group consisting of: insertion speed; insertion acceleration; insertion rise time; insertion dwell time; insertion fall time; insertion force; withdrawal speed; withdrawal acceleration; withdrawal force; core diameter; depth of insertion; microcoring density; microcoring pattern; lateral movement speed; lateral movement direction; lateral movement vector; lateral movement height; microcoring location; microcoring location tolerance; deceleration threshold; undershoot threshold; overshoot threshold; vacuum actuation release delay; vacuum release duration; and combinations thereof. System 10 can be configured to enter an alert state if an undesired and/or unexpected tissue type and/or tissue property is captured and/or identified in a target tissue location. [260] In some embodiments, system 10 is configured to detect the force of an insertion of a coring element 155, the force of a withdrawal of a coring element 155, or both. System 10 can comprise a sensor (e.g., one, two, or more sensor-based functional elements 99 and/or 199) that can be configured to produce a signal, and system 10 can be configured to
Docket No. CYT-014-PCT detect the force based on the sensor signal. The sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; and combinations thereof. As described herein, system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the force detection. In these embodiments, algorithm 25 can comprise an AI-based algorithm, as described herein. System 10 can be configured to adjust the depth of insertion if an undesired force is detected. System 10 can be configured to enter an alert state if the detected force exceeds a threshold. System 10 can be configured to perform an initial insertion and/or withdrawal and detect the associated force, and then adjust the insertion and/or withdrawal force in subsequent reciprocating motions of coring elements 155. [261] In some embodiments, system 10 is configured to set a depth of insertion of the one or more coring elements 155. The depth of insertion can be set based on a tissue analysis performed by system 10. System 10 can comprise a sensor (e.g., one, two, or more sensor- based functional elements 99 and/or 199) that can be configured to produce a signal, and system 10 can be configured to perform the tissue analysis based on the sensor signal. The sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof. As described herein, system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the tissue analysis. In these embodiments, algorithm 25 can comprise an AI-based algorithm, as described herein. [262] In some embodiments, system 10 is configured to detect the presence of a critical structure at a target tissue location. System 10 can comprise a sensor (e.g., one, two, or more sensor-based functional elements 99 and/or 199) that can be configured to produce a signal, and system 10 can be configured to perform the detection of the presence of the critical structure based on the sensor signal. The sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor;
Docket No. CYT-014-PCT accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof. The sensor can comprise an imaging device (e.g., imaging device 50 described herein), and the imaging device can comprise one, two, or more devices selected from the group consisting of: ultrasound imaging device; X-ray imaging device, such as a fluoroscope; OCT imaging device; and combinations thereof. As described herein, system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the detection of the presence of the critical structure. In these embodiments, algorithm 25 can comprise an AI-based algorithm, as described herein. The critical structure can comprise a structure selected from the group consisting of: blood vessel tissue; bone; scar tissue; damaged tissue, such as burned tissue; and combinations thereof. System 10 can comprise one or more reciprocating motion parameters, and system 10 can be configured to adjust a reciprocating motion parameter to avoid inserting the one or more coring elements 155 into the detected critical structure. System 10 can be configured to automatically reduce the depth of insertion based on the detection of the critical structure. System 10 can be configured to enter an alert state when a critical structure can be detected. [263] In some embodiments, system 10 is configured to mark tissue, such as target tissue, non-target tissue, and/or safety margin tissue. System 10 can comprise marking element 91 shown, such as a marking element that is configured to mark tissue. Marking element 91 can comprise one, two, or more marking elements configured to mark tissue with ink, dye, and/or energy such as laser energy. System 10 can be configured to mark tissue to identify a no coring area (e.g., a non-target tissue area), and the no coring area can comprise a tissue surface portion to which microcoring should be avoided. The no coring area can comprise a first tissue surface portion and a second tissue surface portion, such as portions to which microcoring should be avoided. System 10 can be configured to prevent coring in tissue locations marked as non-target tissue by system 10. The treatment module 150 can comprise a spacer, spacer assembly 180 described herein, that includes a window, window 182 shown, and system 10 can be configured to perform multiple reciprocating motions of the one or more coring elements 155 within window 182 of spacer assembly 180. System 10 can be further configured to avoid inserting the coring elements 155 in tissue that has been marked by system 10 as non-target tissue that should not be cored. System 10 can be configured to mark the tissue with a marking pattern that is indicative of non-target tissue.
Docket No. CYT-014-PCT System 10 can be configured to core tissue that has been marked by system 10 as target tissue. System 10 can be configured to perform multiple reciprocating motions of the one or more coring elements 155 within window 182 of spacer assembly 180, and system 10 can be further configured to insert the coring elements 155 in tissue that has been marked by system 10 for coring (e.g., marked as target tissue). System 10 can be configured to mark the tissue with a marking pattern that is indicative of target tissue. In some embodiments, system 10 is configured to mark target tissue with a first marking pattern and to mark non-target tissue with a second marking pattern different than the first marking pattern. In these embodiments, system 10 can be configured to perform multiple reciprocating motions of the one or more coring elements 155 within window 182 of spacer assembly 180, and system 10 can be further configured to insert the coring elements 155 in tissue that has been marked by system 10 with the first pattern and to avoid inserting the coring elements 155 in tissue that has been marked by system 10 with the second pattern. [264] In some embodiments, system 10 is configured to record skin surface data. The skin surface data can comprise photographs and/or other images of the skin surface (e.g., images that are produced by one or more components of system 10). System 10 can be configured to record skin surface data prior to a microcoring procedure and/or after a microcoring procedure. In some embodiments, system 10 is configured to record skin surface data both prior to a microcoring procedure and after a microcoring procedure. As described herein, system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform an analysis of microcoring effectiveness based on a comparison of the skin surface data recorded prior to the microcoring procedure and after the microcoring procedure. System 10 can be configured to record skin surface data prior to a microcoring procedure, and algorithm 25 can be configured to produce a microcoring treatment plan (e.g., an initial treatment plan) based on the skin surface data recorded prior to the microcoring procedure. In these embodiments, algorithm 25 can comprise an AI-based algorithm, as described herein. [265] In some embodiments, system 10 comprises diagnostic assembly 30 shown, such as a diagnostic assembly configured as a self-diagnostic assembly that performs a diagnostic on one or more components of system 10. Diagnostic assembly 30 can be configured to detect damage to a component of system 10. Diagnostic assembly 30 can comprise one or more sensors, sensor 39 shown, such as an acceleration sensor, impact sensor, and/or other
Docket No. CYT-014-PCT sensor configured to produce a signal representative of damage to the component of system 10 being monitored for damage. [266] In some embodiments, system 10 comprises a user interface, such as user interface 510 and/or another user interface of system 10, and the user interface is configured to allow an operator to select a microcoring pattern to be used in a microcoring procedure. In these embodiments, the microcoring pattern can be selected from a set of microcoring patterns made available by system 10, such as microcoring parameters presented on display 511 or other display of system 10. [267] In some embodiments, system 10 comprises one or more user interfaces, collectively including a first input device, input device 512 shown (e.g., a touch screen of user interface 510) and a second input device. The second input device can comprise input device 104 of treatment device 100 and/or input device 513 of user interface 510, each as shown. In these embodiments, system 10 can be configured to receive commands from an operator from either or both of first input device 512 (e.g., a touch screen), as well as input device 104 and/or input device 513. Input device 104 and/or input device 513 can comprise a microphone (e.g., a microphone configured to receive commands from an operator of system 10). System 10 can comprise a handpiece (e.g., housing 110 comprises a hand-held housing) comprising treatment module 150, and input device 104 can be positioned on the handpiece (e.g., on housing 110). System 10 can comprise one or more reciprocating motion parameters, and one, two, or all of input device 512 (e.g., a touch screen), input device 104 and/or input device 513, can be configured to allow an operator to adjust one or more (e.g., all) of the adjustable reciprocating motion parameters. [268] In some embodiments, system 10 comprises a display, display 511 shown, and system 10 is configured to provide “microcoring feedback information” on the display. This feedback information can comprise data selected from the group consisting of: core size data, such as detected core size data; coring element 155 reciprocating motion data; target tissue data; non-target tissue data; and combinations thereof. System 10 can be configured to provide the microcoring feedback information as video on display 511. System 10 can be configured to allow an operator to: play, play in slow motion, pause, rewind, and/or zoom the video. [269] In some embodiments, the one or more coring elements 155 comprise multiple coring elements 155 arranged in a grid of at least one row and at least two columns. Each pair of neighboring columns can be separated by a distance L1, and actuation assembly 120 can be configured to: perform a first reciprocating motion of the multiple coring elements
Docket No. CYT-014-PCT 155; translate the multiple coring elements 155 a distance LT that is a distance less than L1; and then perform a second reciprocating motion of the multiple coring elements 155. System 10 can be configured to translate the multiple coring elements 155 in a direction approximately 45 degrees relative to the axis of the columns. System 10 can be configured to translate the multiple coring elements 155 in a direction relatively orthogonal to the axis of the columns. The orthogonal distance translated can comprise a distance of approximately half of L1. After performing the second reciprocating motion of the multiple coring elements 155, system 10 can be configured to translate the multiple coring elements 155 a distance (e.g., an orthogonal distance) of approximately 1.5 times L1, and then perform a third reciprocating motion of the multiple coring elements 155. After performing the third reciprocating motion of the multiple coring elements 155, system 10 can be configured to translate the multiple coring elements 155 a distance (e.g., an orthogonal distance) of approximately half of L1, and then perform a fourth reciprocating motion of the multiple coring elements 155. The grid can comprise at least two rows, where each pair of neighboring rows can be separated by a distance L2, and the distance LT can comprise a distance that can be greater than L1 and greater than L2. The number of columns of the grid can comprise a quantity that can be at least three times the number of rows of the grid. [270] In some embodiments, the one or more coring elements 155 comprises an array of at least ten coring elements 155. In some embodiments, the one or more coring elements 155 comprises an array of at least 100 coring elements 155. [271] As described herein, system 10 can comprise a spacer, such as spacer assembly 180 described herein, and spacer assembly 180 can apply a vacuum (e.g., via vacuum assembly 560 shown) to a tissue surface being treated by system 10. System 10 can be configured to: apply the vacuum while spacer assembly 180 can be positioned on the patient’s skin at a first location L1; deliver a series of multiple reciprocating motions of the one or more coring elements 155; wait a pre-determined time period T1; and then release the vacuum for a pre-determined time period T2. Spacer assembly 180 can be configured to be repositioned at a second patient skin location L2 during time period T2. Alternatively or additionally, spacer assembly 180 can be configured to be repositioned at a second patient skin location L2 after time period T2 has elapsed. System 10 can comprise a first vacuum source and a second vacuum source, and the first vacuum source can apply a vacuum to spacer assembly 180, and the second vacuum source can apply a vacuum that removes cores from the one or more coring elements 155. System 10 can be configured to provide the vacuum to spacer assembly 180 at a first level, a second level, or both. Vacuum assembly
Docket No. CYT-014-PCT 560 can comprise a first vacuum source 560a configured to provide vacuum at a first level, and a second vacuum source 560b configured to provide vacuum at a second level, and the second level can be different than the first level. The first vacuum source 560a and the second vacuum source 560b can be each configured to be detached from, and/or operably attached to, the treatment module 150. Spacer assembly 180 can comprise: a curved skin- contacting surface; a compressible skin-contacting surface; and/or a flexible skin contacting surface. In some embodiments, spacer assembly 180 and one or more other components of system 10 can be configured to treat the neck of the patient. In these embodiments, the one or more coring elements 155 can comprise a single coring element 155. [272] In some embodiments, system 10 comprises a console, console 500 shown and described herein, that operably attaches to the treatment module 150 and/or actuation assembly 120. Console 500 can comprise a motion detection sensor, such as a sensor that produces a signal indicative of console 500 being moved (e.g., between rooms of an office, a hospital, and/or other setting in which system 10 is used, in a desired or undesired fashion). [273] In some embodiments, system 10 comprises a projection assembly, projection assembly 93 shown, which can be configured to project an image of a microcoring pattern onto a skin surface portion of the patient (e.g., onto the face, neck, or other body portion of a patient). Projection assembly 93 can be integral to the treatment module 150, actuation assembly 120, or both. Projection assembly 93 can comprise a discrete component of system 10. Projection assembly 93 can comprise a laser configured to produce the image of the microcoring pattern. In some embodiments, projection assembly 93 projects an image representing target tissue, safety margin tissue, and/or non-target tissue onto a skin surface of the patient. [274] In some embodiments, system 10 comprises a skin scanning assembly, scanner 94 shown, configured to scan the surface of one or more skin surface portions of the patient. System 10 can comprise a display, display 511 shown, and the scanner 94 can be configured to provide one or more images of the one or more skin surface portions on display 511. System 10 can be configured to allow an operator to mark target tissue to be treated and/or non-target tissue not to be treated, on at least one image provided by scanner 94 on display 511. System 10 can be configured to prevent microcoring in the tissue marked as non-target tissue. System 10 can be configured to automatically perform microcoring in the tissue marked as target tissue. [275] In some embodiments, system 10 comprises a coring element position tracking assembly, tracking assembly 95 shown, and tracking assembly 95 can be configured to track
Docket No. CYT-014-PCT the translation of the treatment module 150 (e.g., coring elements 155) along a skin surface. Tracking assembly 95 can comprise one or more sensors (e.g., an optical sensor and/or other sensor-based functional element 99) that can be configured to detect texture changes in a skin surface. Tracking assembly 95 can be configured to determine when a desired translation distance and/or a translation distance threshold has been reached. [276] In some embodiments, system 10 comprises one or more skin treatment and/or other skin modifying devices, skin modification device 900 shown. In some embodiments, skin modification device 900 comprises a skin-compressing dressing, such as is described in applicant’s co-pending United Stats Patent Application Serial Number 17/987,190, entitled “Methods and Devices for Skin Tightening”, filed November 15, 2022. Such a skin- compressing dressing can be used prior to, during, and/or after a microcoring procedure is performed using treatment device 100. Skin modification device 900 can comprise one or more agents and/or devices configured to modify the properties of skin, and/or to modify the properties of other tissue types proximate to skin. [277] In some embodiments, system 10 comprises an agent delivery assembly, agent delivery assembly 200 shown, and agent delivery assembly 200 can be configured to deliver an agent (e.g., agent 60 described herein) to one or more target tissue locations. Agent delivery assembly 200 can comprise one or more agent delivery elements, agent delivery element 201 shown. The one or more agent delivery elements 201 can comprise one or more elements selected from the group consisting of: needle; fluid jet; iontophoretic element; and combinations thereof. System 10 can comprise a first cartridge, cartridge 2011 shown, that includes the one or more agent delivery elements 201. Cartridge 2011 can be configured to operably attach to the treatment module 150. In some embodiments, cartridge 2011 also includes the one or more coring elements 155 of treatment module 150. Alternatively or additionally, system 10 can further comprise a second cartridge (not shown but such as a cartridge of treatment module 150) that includes the one or more coring elements 155. At least one of the one or more coring elements 155 can comprise at least one of the one or more agent delivery elements 201 (e.g., a single needle or other component both cores tissue and delivers an agent). The one or more coring elements 155 can comprise at least two coring elements 155, and the at least two coring elements 155 can comprise all of the one or more agent delivery elements 201. System 10 can be configured to insert the one or more coring elements 155 at a first insertion rate profile and to insert the at least one agent delivery element 201 at a second insertion rate profile, and the first insertion rate profile can be different than the second insertion rate profile. For example, the two insertion rate profiles
Docket No. CYT-014-PCT can comprise different velocities, accelerations, wait times, and the like. System 10 can be configured to insert the at least one agent delivery element 201 into tissue, wait for a time period T1, and withdraw the at least one agent delivery element 201 from tissue. The at least one agent delivery element 201 can comprise an elongate shaft with a distal end, and the at least one agent delivery element 201 can comprise one or more agent delivery openings positioned at the distal end and/or proximal to the distal end (e.g., a side hole of the shaft). System 10 can comprise an agent (e.g., agent 60 described herein) to be delivered by the agent delivery assembly 200. In these embodiments, agent 60 can comprise one, two, or more agents selected from the group consisting of: an analgesic agent, such as lidocaine; epinephrine; an antibiotic agent; an antifungal agent; a cooling agent; a warming agent; a dye; a radiographic agent; an ultrasonically visible agent; and combinations thereof. In some embodiments, the agent 60 comprises a dermal filler to be delivered by agent delivery assembly 200. [278] In some embodiments, system 10 comprises tissue cooling assembly 92 shown, such as an assembly configured to reduce the temperature of one or more surfaces and/or volumes of tissue of the patient. System 10 can be configured to cool (e.g., via tissue cooling assembly 92) at least a target tissue location at a time prior to performing a microcoring procedure, during a microcoring procedure, and/or after a microcoring procedure. The treatment module 150 and/or actuation assembly 120 can comprise tissue cooling assembly 92. Tissue cooling assembly 92 can comprise a separate component, such as a mask configured to be placed on the patient’s face and extract heat from tissue. Alternatively or additionally, the mask can be configured to compress tissue of the patient. In some embodiments, tissue cooling assembly 92 is configured to at least reduce the use of analgesics in performing the procedure on the patient. [279] In some embodiments, treatment module 150 and actuation assembly 120 comprise a first system 10a, and system 10 further comprises: a second system 10b, not shown but comprising: a second treatment module 150’ comprising a one or more coring elements 155’; and a second actuation assembly 120’ operably attached to the second treatment module 150’ and configured to perform a microcoring procedure comprising the second treatment module 150’ translating in a series of reciprocating motions, each reciprocating motion comprising each coring element 155’ being inserted into and withdrawn from tissue of a patient. A server 20 (e.g., a server connected to network 80 described herein, such as the Internet or privately maintained network) can be configured to receive information from the first system 10a and the second system 10b. System 10 can be
Docket No. CYT-014-PCT configured to update the first system 10a based on at least information received from the second system 10b. [280] In some embodiments, system 10 comprises multiples of one or more of: treatment device 100; console 500; and/or other components of system 10 described herein. For example, one or more of the components of system 10 can be maintained at multiple clinical sites. and these components can communicate (e.g., via a wired or wireless connection via network 80) with each other, and/or with server 20. In these embodiments, system, patient, and other information can be shared between the various components of system 10. For example, each clinical site performing the microcoring and other procedures of the present inventive concepts can include one or more microcoring subsystems 11, such as microcoring subsystem 11a, 11b, 11c through 11n as shown. Each microcoring subsystem 11 can include at least one treatment device 100 (e.g., including one or more actuation assemblies 120), and multiple treatment modules 150 (e.g., multiple treatment modules 150 that are used in multiple clinical procedures on multiple patients). Each microcoring subsystem 11 can include one or more consoles 500, and one or more of the other components shown in Fig.1. In some embodiments, a single network 80 connects multiple microcoring subsystems 11 to each other, and/or to server 20, such as to transfer data between system 10 components at different clinical sites with other clinical sites and/or with server 20 (e.g., via a wired or wireless connection via network 80). [281] System 10 can comprise one or more devices for patients, clinicians, and/or vendors, (singly or collectively, “users” herein) to enter information into system 10, and/or receive information from system 10. For example, system 10 can comprise one or more of each of: patient device 300, clinician device 400, and/or vendor device 700, respectively, each as shown. Each of patient device 300, clinician device 400, and/or vendor device 700 can comprise one, two, or more devices selected from the group consisting of: phone; cell phone; smart phone; computer; laptop computer; tablet computer; smart watch; automobile communication device; a patient-monitoring device (e.g., as described herein); and combinations of these. Each device 300, 400, and/or 700 can each comprise one or more applications (e.g., software applications), patient application 320, clinician application 420, and/or vendor application 720, respectively, as shown. Devices 300, 400, and/or 700 can each comprise a user interface, user interface 350, clinician interface 450, and/or vendor interface 750, respectively, as shown. Devices 300, 400, and/or 700 can each comprise one or more functional elements, such as functional element 399, functional element 499, and/or functional element 799, respectively, as shown. System 10, and/or
Docket No. CYT-014-PCT each subsystem 11, can comprise multiple patient devices 300, multiple clinician devices 400, and/or multiple vendor devices 700, that are used by multiple patients, clinicians, and/or vendors, respectively, the multiple patients, clinicians, and/or vendors associated with an associated subsystem 11 and/or system 10. [282] Devices 300, 400, and/or 700 (singly or collectively, “device 300/400/700”) can each comprise one, two, or more desktop and/or handheld electronic devices. Functional elements 399, 499, and/or 799 (singly or collectively “functional element 399/499/799”), can each comprise a component configured to provide a connection (e.g., a wired or wireless connection) to the Internet or other computer network, network 80 shown, such as to provide communication access to server 20 of system 10. [283] Each device 300/400/700 can be configured to operate in multiple modes of operation, such as multiple modes related to a level of complexity of use (e.g., easy, moderate, and advanced levels of operation), such as to correlate with experience, intelligence, and/or other parameter of a user of device 300/400/700. In some embodiments, a user of a device 300/400/700 utilizes the device with a different level of “involvement”, such as when a first patient uses a device 300a with a first level of involvement (e.g., a minimal level of involvement), and a second patient uses a device 300b with a second level of involvement (e.g., a high level of involvement). In some embodiments, patient device 300 is configured to operate in a “parent/guardian” mode, such as when the device 300 is being used by a parent and/or guardian of a patient which has received, and/or may in the future receive, a microcoring treatment via treatment device 100. In some embodiments, a single clinician device 400 is used by multiple clinicians, and at least two clinicians operate device 400 in different modes of operation. [284] System 10 can be configured to record (e.g., and store in memory) various information related to the patient, patient data PD or data PD described herein. Data PD can be received from: the patient; a family member of the patient (e.g., when the patient is a minor); one or more clinicians of the patient; a phone or other device of the patient; and/or by other information sources or devices. Data PD can comprise various information related to the patient’s current location (e.g., via a phone or other GPS enabled device), the patient’s home, and/or office location. Data PD can include patient demographic and physiologic information, and/or other patient information, such as patient data including but not limited to: patient image data; patient lifestyle data; patient medical history data (e.g., data related to one or more infections previously encountered by the patient); age data; race data; sex data; weight data; body mass index data; skin quality and/or other skin characterization data;
Docket No. CYT-014-PCT patient health data; patient allergy data; data related to a previous microcoring procedure; data related to a previous surgical and/or other clinical procedure; DNA and/or other genetic data; data related to medications taken by the patient; patient diet data; patient location data (e.g., data related to the patient’s home or other location associated with the patient); patient travel data; patient occupation data; patient financial data; data related to one or more clinicians in the relative proximity (e.g., within 10, 20, or 30 miles) of the home or other associated location of the patient; and/or data related to one or more drug stores in the relative proximity (e.g., within 10, 20, or 30 miles) of the home or other associated location of the patient. In some embodiments, system 10 is configured to allow a user (e.g., the patient) to set a distance to be used in calculations involving relative proximity to a patient location. Data PD can comprise data related to desired outcomes of the patient (e.g., desired outcomes provided by the patient, a clinician of the patient, or both). Data PD can comprise various information related to the patient, as described herein. [285] System 10 can be configured to record (e.g., and store in memory) various information related to a clinician, clinician data CD or data CD herein. Data CD can be received from the clinician or other source. Data CD can comprise various information related to the clinician, such as: clinician office location; clinician current location information; clinician accreditations; clinician procedures offered; clinician procedure performance information; and/or other clinician information. [286] System 10 can be configured to record (e.g., and store in memory) various information related to a vendor, vendor data VD or data VD herein. The vendor can be a manufacturer and/or distributor of one or more skincare, healthcare, and/or other patient and/or clinician available products. The vendor can be a business partner of, and/or otherwise have a business arrangement with, the manufacturer of system 10. Data VD can be received from the vendor or other source. Data VD can comprise various information related to the vendor, such as: vendor location; products offered; prices of products; and/or other vendor information. [287] System 10 can be configured to record, monitor, and/or store system data SD or data SD herein. System data SD can include information selected from the group consisting of: current revisions of software and/or hardware of one or more components of system 10; system 10 use information; system 10 location information; system 10 age information; and combinations of these. [288] In some embodiments, system 10 is configured to record (e.g., and store in memory) information from a patient via a patient device 300, patient provided data PPD or
Docket No. CYT-014-PCT data PPD herein. Data PPD can comprise various patient-provided patient information, such as one or more forms of data PD described herein, and/or other information provided by the patient. Data PPD can comprise data CD (e.g., a preferred clinician of the patient) and/or data VD (e.g., a preferred vendor of the patient). Patient device 300 can include one or more data recording components, such as a user interface 350 comprising one or more data recording components. For example, user interface 350 can comprise a camera, a microphone, a keyboard, a touchscreen, a mouse, a joystick, and/or other user input component configured to record (e.g., and store in memory) data from a patient and/or a patient’s guardian, family member, and/or friend (“patient” herein). In some embodiments, a patient device 300 comprises one, two, or more patient-monitoring devices (e.g., devices that monitor, record, analyze, and/or store data related to the patient), such as one, two, or more devices selected from the group consisting of: camera or camera system (e.g., a camera configured to record images of the patient’s face or other patient tissue); exercise monitoring device; sleep monitoring device; sleep apnea monitoring device; EKG and/or other heart monitoring device; EEG and/or other brain monitoring device; blood pressure monitoring device; blood glucose-monitoring device; implanted sensor device; other health-monitoring device; a patient location device (e.g., a device including a GPS sensor); and combinations of these. In some embodiments, system 10 is configured (e.g., via algorithm 25, for example an AI Algorithm) to manipulate and/or otherwise analyze patient data PD obtained from a camera to predict potential outcomes (e.g., efficacy potential) of a future microcoring procedure to be performed on the patient. In some embodiments, data PD from multiple patients is analyzed by system 10 (e.g., via algorithm 25) to profile and/or identify one or more patients that are predicted to have desired (e.g., optimized and/or otherwise desirable by the patient) outcomes (e.g., of a microcoring procedure performed by system 10). In some embodiments, the data PD is used by system 10 (e.g., via algorithm 25, for example an AI algorithm) to identify patients with similar demographic and/or clinical profiles, such as to share outcomes achieved by other patients with similar profiles. [289] In some embodiments, user interface 350 comprises a camera configured to record data PD (e.g., data PPD) comprising one or more photographs of the patient (e.g., one or more “selfies”), image data ID described herein. These patient images can be transmitted (e.g., via network 80) to one or more clinicians (e.g., to a user interface 450 of a clinician device 400), such as to enable the clinician to assess a previous or future microcoring procedure performed using treatment device 100. Alternatively or additionally, the patient images can be transmitted to console 500 and/or server 20, such that an algorithm of system
Docket No. CYT-014-PCT 10 can analyze the images (e.g., images of skin portions to be treated and/or skin portions already treated using treatment device 100) to determine tissue treatment parameters to be used in one, two, or more future microcoring procedures to be performed using treatment device 100, and/or to determine continued other treatments to be performed (e.g., medications given and/or skin and/or other tissue treatments performed) as part of post-microcoring treatment plan undertaken after a microcoring procedure using treatment device 100 is performed. [290] In some embodiments, user interface 350 comprises a text or voice capturing component (e.g., a microphone or keyboard) that records one or more requests of the patient. In some embodiments, the patient enters one or more proposed “level of treatments” (e.g., levels of microcoring treatments), and system 10 provides a simulation of the effect of the various levels. For example, system 10 (e.g., via algorithm 25, for example an AI algorithm) can create simulated images (also referred to as “predicted images”) of the patient that correlate to the various levels of treatment selected by the patient. [291] In some embodiments, system 10 is configured to record information provided by a clinician (e.g., from a clinician via a clinician device 400), clinician provided data CPD or data CPD herein. Data CPD can comprise patient data PD, clinician data CD, vendor data VD, and/or other information that is provided by the clinician. Clinician device 400 can include one or more data recording components, such as a user interface 450 comprising one or more data recording components. For example, user interface 450 can comprise a camera, a microphone, a keyboard, a touchscreen, a mouse, a joystick, and/or other user input component configured to record (e.g., and store in memory) data from a clinician and/or a clinician’s assistant (e.g., a nurse or other assistant, “clinician” herein). [292] In some embodiments, system 10 is configured to record information provided by a vendor (e.g., from a vendor via a vendor device 700), vendor provided data VPD or data VPD herein. Data VPD can comprise patient data PD, clinician data CD, vendor data VD, and/or other information that is provided by the vendor. Vendor device 700 can include one or more data recording components, such as a user interface 750 comprising one or more data recording components. For example, user interface 750 can comprise a camera, a microphone, a keyboard, a touchscreen, a mouse, a joystick, and/or other user input component configured to record (e.g., and store in memory) data from a vendor. [293] In some embodiments, system 10 is configured to provide information, system provided data SPD or data SPD herein. Data SPD can be provided to a patient (e.g., via a patient device 300), to a clinician (e.g., via a clinician device 400), and/or to a vendor (e.g.,
Docket No. CYT-014-PCT via a vendor device 700). Data SPD can be customized (e.g., customized by algorithm 25, for example an AI algorithm), based on one or more patient parameters selected from the group consisting of: patient vicinity data PVD (e.g., a current or planned future location of the patient, and/or the location of the patient’s home and/or office); patient age, race, and/or other patient demographic data; history and physical exam data (H&P data); location of a clinician (e.g., location of a clinician in the general proximity to the current location of the patient or the patient’s home or office); location of a drug store (e.g., location of a drug store in the general proximity to the current location of the patient or the patient’s home or office); and combinations of these. [294] Data SPD provided to the patient by device 300 can comprise educational information, such as information intended to educate the patient about system 10, such as information related to microcoring and/or other procedures performed using system 10 (e.g., procedures performed by a clinician and/or other operator using treatment device 100). [295] Data SPD provided to the patient by device 300 can comprise information related to one or more clinicians or other operators of system 10 (e.g., information related to clinicians in the local vicinity to the current location of the patient and/or the location of the patient’s home or office). [296] Data SPD provided to the patient by device 300 can comprise information related to an appointment the patient has or can have with a clinician, such as an appointment related to a previous or future microcoring procedure performed using treatment device 100. For example, data SPD can be provided to assist the patient in scheduling an appointment with a clinician. [297] Data SPD provided to the patient by device 300 can comprise information related to one or more suggested tasks for a patient to perform, such as a task to be performed prior to a microcoring treatment performed using treatment device 100 (e.g., take a medication, apply a topical substance, avoid the sun or put on sunscreen, and/or perform another task) and/or a task to be performed after microcoring treatment using treatment device 100 (e.g., take a medication, apply a topical substance, avoid the sun or put on sunscreen, and/or perform another task). This provided information can be coordinated with a time duration prior to and/or after a microcoring treatment using treatment device 100 (e.g., “it is X days prior to your microcoring procedure, perform the following task” and/or “it is X days after your microcoring procedure, perform the following task”). Data SPD can comprise information related to a suggested appointment to be scheduled (e.g., “please schedule an appointment approximately X days from now”).
Docket No. CYT-014-PCT [298] System 10 can be configured to transmit data to a receiving component of system 10 (e.g., treatment device 100, patient device 300, clinician device 400, and/or vendor device 700 configured to receive data). Alternatively or additionally, system 10 can be configured to receive data from a transmitting component of system 10 (e.g., treatment device 100, patient device 300, clinician device 400, and/or vendor device 700 configured to transmit data). In some embodiments, system 10 is configured to provide treatment data TD (e.g., information related to one or more microcoring treatments performed using treatment device 100) to a patient, a clinician, and/or a vendor (e.g., via patient device 300. clinician device 400, and/or vendor device 700, respectively). Data TD can include treatment date, treatment time, system 10 settings of a microcoring or other treatment, and/or other treatment information. Data TD can include information recorded via a QR code of a treatment device 100 (e.g., a QR code scanned by a functional element of treatment device 100 and/or console 500 comprising a camera). Treatment information can comprise one or more images of the patient (e.g., one or more photographs of a skin portion of the patient that is to be treated and/or has already been treated using treatment device 100). In some embodiments, algorithm 25 (e.g., an AI algorithm) is configured to analyze data TD (e.g., one or more images of the patient) to determine microcoring treatment settings and/or post-microcoring treatment settings. Data TD can provide a record (e.g., a validation) that a microcoring or other procedure performed using system 10 was performed, for example the record including the location, time, and/or date. The record can correlate this data with system 10 settings used in a microcoring procedure, and/or with post-procedural result data (e.g., post procedural images and/or other efficacy information). Operator (e.g., clinician operator) technique quality can be recorded by system 10 via inertial measurement units (IMUs), such as to identify one or more of: treatment device 100 movement relative to anatomy; smoothness of treatment device 100 movement; and/or detection of treatment device 100 treating the same location. In these embodiments, functional element 199 of treatment device 100, and/or another functional element of system 10, can comprise one or more accelerometers and/or other sensors configured to produce motion and/or position data of device 100. System 10 can be configured to: collect movement, position, and/or other data across multiple operators of system 10; calculate population analytics to determine and identify operators that achieve and/or are likely to achieve optimized outcomes; and/or compare operator technique data of multiple operators such as to compare operators (e.g., and provide feedback to one or more operators).
Docket No. CYT-014-PCT [299] System 10 can be configured to allow a user to upload and/or download various information stored by one or more components of system 10. For example, patient information PI, clinician information CI, and/or treatment information data TD can be transferred between (e.g., uploaded from and/or downloaded to) server 20, treatment device 100, patient device 300, clinician device 400, console 500, and/or vendor device 700. In some embodiments, a clinician transfers information to a clinician device 400. In some embodiments, information is uploaded to a “cosmetic community” web hosting site. In some embodiments, system 10 is configured to share collected information (e.g., treatment data TD, patient data PD, and/or other data collected by system 10) with one or more of: clinicians, patients, a parent of a patient, and/or an information “portal”. In some embodiments, system 10 is configured to set up (i.e., create) one or more of: a community event; a training workshop such as an online training workshop; a consult, such as a virtual (e.g., web meeting) consult; and/or a virtual (e.g., web meeting) event. [300] System 10 can be configured to provide suggestions for post-microcoring care of a patient (e.g., to be performed by a patient and/or their clinician). In some embodiments, system 10 provides advertisements to a patient, a clinician, and/or a vendor, such as advertisements related to products (e.g., skin modification device 900 described herein) to be used in the post-microcoring care (e.g., products that enhance healing and/or the cosmetic improvements of the microcoring procedure). In some embodiments, system 10 is configured to provide post-microcoring care reminders, such as temporal reminders suggesting the use of one or more products (e.g., skin modification device 900 described herein) at particular times (e.g., to be performed on particular days after the performance of the microcoring procedure). In these embodiments, skin modification device 900 can comprise a product configured to deliver an agent selected from the group consisting of: hyaluronic acid; a moisturizer; an analgesic; a peptide; exosomes; platelet-rich plasma (PRP); arnica montana extract; a vasoconstrictor; methotrexate; minoxidil; stem cells; botulinum toxin; a corticosteroid; and combinations of these. In some embodiments, system 10 (e.g., via algorithm 25, for example an AI algorithm) is configured to define a profile of a user (e.g., a patient, clinician, and/or vendor) and/or make suggestions to that user based on a parameter of that user, such as a parameter selected from the group consisting of: buying habits; interests; opportunity to sell to other product or service providers interested in this demographic; and combinations of these. In some embodiments, system 10 is configured to offer for sale post-operative care, such as post-operative care offered via an online marketplace. In these embodiments, system 10 (e.g., the manufacturer of system 10) can serve as a “broker” between vendors, clinicians,
Docket No. CYT-014-PCT and/or patients, such as by selling personalized and optimal add-on products (e.g., skin care products, pre and/or post-microcoring treatment products, and/or other products) to the patients. [301] System 10 can be configured to provide a “discount” (e.g., a reduction in a standard amount of payment for a good or service), such as a discount provided to a patient, a clinician, and/or a vendor. For example, system 10 can be configured to provide a “refer a friend” function. In these embodiments, a discount to a system 10 product and/or a service provided by system 10 can be provided to a user based on the referring of another potential user. In some embodiments, system 10 is configured to provide a discount if an appointment is established within a pre-determined timeframe (e.g., receive a discount “if you book today”). In some embodiments, system 10 is configured to receive a payment, such as a payment made by a patient, a clinician, and/or a vendor. In some embodiments, system 10 is configured to process a payment (e.g., a refund, payment for services, and/or other payment) to a clinician, a vendor, and/or a patient. In some embodiments, system 10 is configured to receive a payment (e.g., a commission) from a vendor, such as a commission based on a product of that vendor that is sold because of and/or related to a microcoring procedure performed using system 10. [302] System 10 can be configured to provide an interface to a social media platform (e.g., X, Instagram, and the like). For example, system 10 can be configured such that a patient, clinician, and/or vendor, using a device 300, 400, and/or 700, respectively, can transfer information from and/or to a social media platform. For example, a patient and/or other user of system 10 can transfer particular patient data PD to a social media platform (also referred to as “posting”). Alternatively or additionally, a patient or other user can receive information from a social media platform. In some embodiments, system 10 (e.g. algorithm 25, for example an AI algorithm) is configured to search one, two, or more social media platforms, and identify other patients that have received a microcoring procedure (other patients that have been treated using system 10), such as to allow a patient (e.g. a potential or future patient) the opportunity to gain information and/or connect with (e.g., “friend”) the one or more other patients. [303] System 10 can be configured to allow a user (e.g., a patient and/or a clinician) to provide a review of another user (e.g., a clinician and/or a vendor) and/or a user’s product (e.g., a product of a clinician and/or a vendor). For example, a patient can provide a review (e.g., a quantitative and/or qualitative assessment) of a clinician (and/or the office staff of that clinician) that performed a microcoring procedure on that patient, and/or an assessment of a
Docket No. CYT-014-PCT product obtained from a clinician and/or a vendor. System 10 (e.g., via algorithm 25, for example an AI algorithm) can be configured to perform population analytics, such as to identify similar patients and/or clinician profiles, such as for sharing with (e.g., distribution to) one or more potential patients and/or clinicians. [304] System 10 can be configured to allow a device 300/400/700 to download information from one or more treatment devices 100, agent delivery assemblies 200, and/or consoles 500. The information can be downloaded via a wired and/or wireless connection provided by network 80. For example, a clinician device 400 can download information related to a microcoring procedure performed using a treatment device 100 on a particular patient of the clinician, such as to maintain a treatment log for that patient. A clinician device 400 can be configured to receive summary data reports for one or more (e.g., all) patients of the clinician(s) associated with that particular clinician device 400. In some embodiments, treatment logs of multiple patients of a clinician are compared by system 10 (e.g., via algorithm 25, for example an AI algorithm), such as to identify discrepancies, trends, and/or other comparative information. In some embodiments, treatment logs of multiple patients of two or more clinicians are compared by system 10 (e.g., via algorithm 25, for example an AI algorithm), such as to identify discrepancies, trends, and/or other comparative information (e.g., differences between patients, between clinicians, or both). [305] System 10 can be configured to allow a clinician and/or a vendor, via clinician device 400 and/or vendor device 700, to create advertising materials, such as advertising materials that are transmitted to patient device 300, server 20, and/or network 80 (e.g., the Internet). For example, clinician and/or vendor advertising can be posted on one or more patient device 300 (e.g., on each applicable patient device 300), on broadcast media (e.g., television or radio), and/or on a website (e.g., a website of the clinician, vendor, and/or manufacturer of system 10). In some embodiments, system 10 is configured to provide information (e.g., curated references) regarding patients who are identified by system 10 as potential candidates for a microcoring and/or other procedure to be performed using system 10, such as when that patient is predicted by system 10 to achieve optimized or at least reasonable outcomes from the system 10 procedure. [306] In some embodiments, system 10 is configured to provide a “link” between a patient and one or more clinicians, such as a link in which certain communications with the patient and/or the clinician are also sent to the other party. In these embodiments, creation of the link may require confirmation that the link is acceptable, such as confirmation required of the patient, the clinician, or both.
Docket No. CYT-014-PCT [307] In some embodiments, system 10 is configured to provide instructions and/or reminders to a patient regarding pre-procedural tasks (e.g., tasks to be performed prior to a microcoring procedure), such as to reduce time in a clinical setting (e.g., clinician’s office) for the patient when receiving a microcoring procedure. [308] In some embodiments, system 10, such as via patient device 300, is configured to allow a patient (e.g., a prospective patient) to enter a “desired procedure” into system 10. In these embodiments, algorithm 25 (e.g., an AI algorithm) can be configured to provide feedback to the patient (e.g., via device 300), such as feedback comprising: one or more system 10 created images of the patient (e.g., the patient’s face or other treatment area) approximating the appearance of the patient after the desired procedure is performed; an assessment of the appropriateness of the desired procedure for the patient; one or more alternative suggested procedures (e.g., determined to be more appropriate by system 10 than the desired procedure); and combinations of these. In some embodiments, system 10 can be configured to produce a three-dimensional (3D) “selfie” (i.e., image of the patient’s face or other body portion) representing the current condition of the patient (e.g., using patient images provided by the patient or otherwise) and/or representing a predicted outcome of a microcoring and/or other procedure performed on that patient using system 10. The 3D selfie can be produced either via stitching multiple two-dimensional (2D) images and/or using augmented reality. [309] In some embodiments, system 10, such as via algorithm 25 (e.g., an AI algorithm), is configured to create a set of system-created patient images, “predicted images” or “predicted patient images”, that represent simulated outcomes of one or more microcoring procedures to potentially be performed on a patient. For example, one or more actual patient photos can be input into system 10 (e.g., via a camera of patient device 300 or other system component as described herein), as well as one or more sets of microcoring parameters. Algorithm 25 can produce images that simulate the outcome based on these two types of data. In some embodiments, a clinician can iteratively change the microcoring settings, such as to determine an optimized set of these settings based on the algorithm- created images (e.g., to enhance and/or predict patient satisfaction that results from the performance of the subsequent microcoring procedure). [310] In some embodiments, system 10, such as via algorithm 25 (e.g., an AI algorithm), is configured to suggest a type of clinician, and/or suggest a particular clinician to a patient. For example, algorithm 25 can analyze patient data PD (e.g., data PD comprising: patient images; patient desired outcomes data; patient physiologic data; patient location data;
Docket No. CYT-014-PCT patient demographic data; patient financial data; and/or other patient data), as well as clinician data CD (e.g., data CD comprising clinician performance data; clinician skill level data; clinician office location data; clinician available techniques and/or equipment data; and/or other clinician data), and provide a suggested clinician or set of clinicians to a patient. In some embodiments, system 10 is configured to perform population analytics to determine which clinician of a set of multiple clinicians has treated the highest quantity of similar profile patients. [311] In some embodiments, system 10 is configured to create and/or provide advertising of a promotional event or other event associated with the use of system 10. For example, system 10 can be configured to send a group email, provide information to a social media platform, and/or provide information to a device 300/400/700. In some embodiments, system 10 is configured to organize and/or otherwise cause to occur: one or more virtual events; one or more live events; or both. [312] In some embodiments, system 10 is configured to “harvest data” (e.g., gather data from one or more system 10 components), such as to process, analyze, log, disseminate, and/or sell the harvested data and/or an analysis of the harvested data. In some embodiments, algorithm 25 (e.g., an AI algorithm) is configured to assist in the harvesting of the data, perform an analysis of the harvested data, or both. For example, system 10 can be configured to sell data (e.g., non HIPAA data) to third parties (e.g., vendors associated with system 10 as described herein and/or other parties). In some embodiments, system 10 is configured to sell the data to vendors that sell cosmetic products or other products associated with a treatment performed using system 10 (e.g., products used as part of post-microcoring treatment care). In some embodiments system 10 is configured to sell data to vendors who sell products to similar customers (e.g., customers of similar income levels and/or customers who are associated with seeking improvements in their physical appearance). [313] In some embodiments, system 10 is configured to harvest data to perform a registry study, such as to reduce the cost of the registry study. In these embodiments, system 10 can be configured to reduce the complexity of the patient-consenting process, such as to support and/or enhance enrolling of patients from multiple clinical practices into a multiple- site study. In some embodiments, system 10 is configured to provide other collaborative clinical study tools, such as to provide an automated creation of documents for submittal to an internal review board (e.g., of a hospital or other clinical setting). [314] In some embodiments, system 10 is configured to upload IOT data (“internet of things” data), such as IOT data uploaded by one or more components of system 10. In some
Docket No. CYT-014-PCT embodiments, algorithm 25 (e.g., an AI algorithm) is configured to identify the IOT data to be uploaded, perform an analysis on the IOT data that is uploaded, or both. [315] The above-described embodiments should be understood to serve only as illustrative examples; further embodiments are envisaged. Any feature described herein in relation to any one embodiment may be used alone, or in combination with other features described, and may also be used in combination with one or more features of any other of the embodiments, or any combination of any other of the embodiments. Furthermore, equivalents and modifications not described above may also be employed without departing from the scope of the invention, which is defined in the accompanying claims.
Claims
Docket No. CYT-014-PCT WHAT IS CLAIMED IS: 1. A system for performing a cosmetic procedure on multiple patients, the system comprising: at least one microcoring subsystem, each microcoring subsystem comprising: at least one treatment device, each treatment device comprising: a set of multiple treatment modules, each treatment module comprising one or more coring elements; and at least one actuation assembly, each actuation assembly configured to operably attach to a treatment module and configured to perform a microcoring procedure comprising the treatment module translating in a series of reciprocating motions, each reciprocating motion comprising each coring element being inserted into and withdrawn from tissue of a patient. 2. The system according to claim 1 and/or any one or more other claims herein, wherein the at least one microcoring subsystem comprises a first microcoring subsystem located at a first clinical location and a second microcoring subsystem located at a second clinical location different than the first clinical location. 3. The system according to claim 2 and/or any one or more other claims herein, wherein the first microcoring subsystem comprises a first set of devices comprising multiple patient devices, multiple clinician devices, and/or multiple vendor devices in communication with the first microcoring subsystem and the second microcoring subsystem comprises a second set of devices comprising multiple patient devices, multiple clinician devices, and/or multiple vendor devices in communication with the second microcoring subsystem. 4. The system according to claim 1 and/or any one or more other claims herein, wherein the at least one treatment device comprises two or more treatment devices. 5. The system according to claim 1 and/or any one or more other claims herein, further comprising a network and/or a server, wherein the network and/or server are
Docket No. CYT-014-PCT configured to receive data from each microcoring subsystem of the at least one microcoring subsystem. 6. The system according to claim 1 and/or any one or more other claims herein, further comprising: at least one patient device; at least one clinician device; and/or at least one vendor device. 7. The system according to claim 1 and/or any one or more other claims herein, wherein each microcoring subsystem of the at least one microcoring subsystem comprises one, two, or more components selected from the group consisting of: at least one console; at least one imaging device; at least one implant; at least one tissue collection assembly; and combinations thereof. 8. The system according to claim 1 and/or any one or more other claims herein, wherein the microcoring procedure is configured to provide a cosmetic effect to the patient. 9. The system according to claim 1 and/or any one or more other claims herein, wherein the series of reciprocating motions comprises at least one reciprocating motion. 10. The system according to claim 9 and/or any one or more other claims herein, wherein the series of reciprocating motions comprises at least two reciprocating motions. 11. The system according to claim 1 and/or any one or more other claims herein, wherein the actuation assembly is further configured to translate the treatment module in one or more directions relative to a surface of skin tissue of the patient. 12. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to perform the series of reciprocating motions based on one, two, or more reciprocating motion parameters. 13. The system according to claim 1 and/or any one or more other claims herein, wherein the system further comprises a patient device that includes a patient app.
Docket No. CYT-014-PCT 14. The system according to claim 13 and/or any one or more other claims herein, wherein the patient device comprises one, two, or more devices selected from the group consisting of: phone; cell phone; smart phone; computer; laptop computer; tablet computer; automobile communication device; a patient- monitoring device; and combinations thereof. 15. The system according to claim 14 and/or any one or more other claims herein, wherein the patient device comprises at least one patient-monitoring device. 16. The system according to claim 15 and/or any one or more other claims herein, wherein the at least one patient-monitoring device comprises one, two, or more devices selected from the group consisting of: camera or camera system; exercise monitoring device; sleep monitoring device; sleep apnea monitoring device; EKG and/or other heart monitoring device; EEG and/or other brain monitoring device; blood pressure monitoring device; blood glucose-monitoring device; other health-monitoring device; a patient location device; and combinations thereof. 17. The system according to claim 14 and/or any one or more other claims herein, wherein the patient device is configured for multiple modes of operation. 18. The system according to claim 17 and/or any one or more other claims herein, wherein the multiple modes of operation comprise different levels of complexity. 19. The system according to claim 17 and/or any one or more other claims herein, wherein the multiple modes of operation comprise different levels of involvement of two or more of the multiple patients. 20. The system according to claim 17 and/or any one or more other claims herein, wherein the multiple modes of operation comprise a parent- guardian mode of operation. 21. The system according to claim 14 and/or any one or more other claims herein, wherein the patient device is configured to provide information to a patient.
Docket No. CYT-014-PCT 22. The system according to claim 21 and/or any one or more other claims herein, wherein the system is configured to receive patient parameter data and wherein the information provided to the patient is customized based on the patient parameter data. 23. The system according to claim 22 and/or any one or more other claims herein, wherein the patient parameter data comprises patient location data. 24. The system according to claim 22 and/or any one or more other claims herein, wherein the patient parameter data comprises: patient image data; patient lifestyle data; patient medical history data; age data; race data; sex data; weight data; body mass index data; skin quality and/or other skin characterization data; patient health data; patient allergy data; data related to a previous microcoring procedure; data related to a previous surgical and/or other clinical procedure; DNA and/or other genetic data; data related to medications taken by the patient; patient diet data; patient location data; patient travel data; patient occupation data; and/or patient financial data. 25. The system according to claim 22 and/or any one or more other claims herein, wherein the patient parameter data comprises data related to one or more clinicians in relative proximity to the home or other associated location of the patient. 26. The system according to claim 22 and/or any one or more other claims herein, wherein the patient parameter data comprises data related to one or more drug stores in relative proximity to the home or other associated location of the patient. 27. The system according to claim 21 and/or any one or more other claims herein, wherein the information provided to the patient comprises microcoring procedure education information.
Docket No. CYT-014-PCT 28. The system according to claim 21 and/or any one or more other claims herein, wherein the information provided to the patient comprises post- microcoring procedure information. 29. The system according to claim 28 and/or any one or more other claims herein, wherein the information provided to the patient comprises information related to applying sunscreen or other topical agent, taking a medication, or both. 30. The system according to claim 28 and/or any one or more other claims herein, wherein the information provided to the patient comprises information related to a future appointment of the patient with a clinician. 31. The system according to claim 21 and/or any one or more other claims herein, wherein the patient device is configured to record patient data. 32. The system according to claim 31 and/or any one or more other claims herein, wherein the patient data recorded comprises: age data; race data; sex data; weight data; body mass index data; skin quality and/or other skin characterization data; patient health data; patient allergy data; data related to a previous microcoring procedure; data related to a previous surgical and/or other clinical procedure; DNA and/or other genetic data; data related to medications taken by the patient; patient diet data; patient location data; patient travel data; patient occupation data; and/or patient financial data. 33. The system according to claim 31 and/or any one or more other claims herein, wherein the system is configured to accept the patient data from multiple data sources. 34. The system according to claim 31 and/or any one or more other claims herein, wherein the patient data comprises data collected after the performance of a microcoring procedure.
Docket No. CYT-014-PCT 35. The system according to claim 34 and/or any one or more other claims herein, wherein the system is configured to provide the patient data to a clinician of the patient. 36. The system according to claim 34 and/or any one or more other claims herein, wherein the system is configured to provide the patient data to a cosmetic community. 37. The system according to claim 21 and/or any one or more other claims herein, wherein the patient device is configured to provide a “refer-a-friend” function. 38. The system according to claim 37 and/or any one or more other claims herein, wherein the system is configured to provide a patient with a discount for each future patient recommended by the patient. 39. The system according to claim 21 and/or any one or more other claims herein, wherein the patient device is configured to provide a patient interface to one or more social media platforms. 40. The system according to claim 1 and/or any one or more other claims herein, further comprising a clinician device that includes a clinician app. 41. The system according to claim 40 and/or any one or more other claims herein, wherein the clinician device comprises one, two, or more devices selected from the group consisting of: phone; cell phone; smart phone; computer; laptop computer; tablet computer; automobile communication device; a patient- monitoring device; and combinations thereof. 42. The system according to claim 40 and/or any one or more other claims herein, wherein the clinician device is configured for multiple modes of operation. 43. The system according to claim 42 and/or any one or more other claims herein, wherein the clinician device is configured to be used by multiple clinicians, and wherein a first mode of operation is configured for use by a first clinician and a second mode of operation is configured for use by a second clinician.
Docket No. CYT-014-PCT 44. The system according to claim 40 and/or any one or more other claims herein, wherein the clinician device is configured to provide a clinician advertising function. 45. The system according to claim 40 and/or any one or more other claims herein, wherein the clinician device is configured to receive summary data reports. 46. The system according to claim 1 and/or any one or more other claims herein, further comprising a vendor device that includes a vendor app. 47. The system according to claim 46 and/or any one or more other claims herein, wherein the vendor device is configured to provide an advertising access function. 48. The system according to claim 1 and/or any one or more other claims herein, further comprising a controller and a memory storage component coupled to the controller, wherein the memory storage component stores instructions for the controller to perform an algorithm, and wherein the algorithm is configured to provide an algorithm output. 49. The system according to claim 48 and/or any one or more other claims herein, wherein the algorithm comprises an artificial intelligence algorithm. 50. The system according to claim 48 and/or any one or more other claims herein, wherein the algorithm provides the algorithm output based on images of a patient. 51. The system according to claim 48 and/or any one or more other claims herein, wherein the system is configured to record patient data, clinician data, and/or vendor data, and wherein the algorithm provides the algorithm output based on one, two, or three of: patient data; clinician data; and/or vendor data. 52. The system according to claim 48 and/or any one or more other claims herein, wherein the system is configured to record patient data, and wherein the algorithm provides the algorithm output based on patient data selected from the group consisting of: age data; race data; sex data; weight data; body mass index data; skin quality and/or other skin characterization data; patient health data;
Docket No. CYT-014-PCT patient allergy data; data related to a previous microcoring procedure; data related to a previous surgical and/or other clinical procedure; DNA and/or other genetic data; data related to medications taken by the patient; patient diet data; patient location data; patient travel data; patient occupation data; patient financial data; and combinations thereof. 53. The system according to claim 48 and/or any one or more other claims herein, wherein the algorithm is adjustable. 54. The system according to claim 53 and/or any one or more other claims herein, wherein the algorithm is configured to be adjusted by a clinician. 55. The system according to claim 48 and/or any one or more other claims herein, wherein the system is configured to record patient data, and wherein the algorithm is configured to manipulate and/or otherwise analyze the patient data and predict a potential outcome of the microcoring procedure. 56. The system according to claim 55 and/or any one or more other claims herein, wherein the patient data comprises patient data recorded from a camera. 57. The system according to claim 48 and/or any one or more other claims herein, wherein the system is configured to record patient data, and wherein the algorithm is configured to analyze the patient data and profile and/or identify one or more patients that are predicted to have a desired outcome of the microcoring procedure. 58. The system according to claim 48 and/or any one or more other claims herein, wherein the system is configured to record patient data, and wherein the algorithm is configured to identify patients with similar demographic and/or clinical profiles. 59. The system according to claim 58 and/or any one or more other claims herein, wherein the system is configured to share outcomes achieved by other patients with similar profiles.
Docket No. CYT-014-PCT 60. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to operate in a clinician link mode in which the system produces clinician-linked information, and wherein the clinician-linked information is related to a particular clinician. 61. The system according to claim 60 and/or any one or more other claims herein, wherein the clinician-linked information output by the system comprises data provided to a patient that is based on a clinician of the patient. 62. The system according to claim 60 and/or any one or more other claims herein, wherein the clinician-linked information output by the system comprises patient data provided to a clinician of a patient, and wherein the patient data is provided prior to a microcoring procedure. 63. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to allow a patient to enter the parameters of a desired microcoring procedure. 64. The system according to claim 63 and/or any one or more other claims herein, wherein the system is further configured to provide an assessment of the applicability of the desired microcoring procedure. 65. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to provide a predicted outcome of a proposed microcoring procedure on a patient. 66. The system according to claim 65 and/or any one or more other claims herein, wherein the predicted outcome comprises predicted images of the patient that comprise estimations of the patient’s skin sometime after the microcoring procedure is performed. 67. The system according to claim 66 and/or any one or more other claims herein, wherein the predicted images are based on patient provided images.
Docket No. CYT-014-PCT 68. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to provide a prediction of patient satisfaction that will result after the performance of a microcoring procedure. 69. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to advertise a promotional event. 70. The system according to claim 69 and/or any one or more other claims herein, wherein the advertising comprises advertising provided via a group email and/or information provided on a social medial platform. 71. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to perform data harvesting related to data produced in one or more microcoring procedures performed by the system. 72. The system according to claim 71 and/or any one or more other claims herein, wherein the data harvesting is configured to produce harvested data, and wherein the system is configured to sell the harvested data. 73. The system according to claim 72 and/or any one or more other claims herein, wherein the system is configured to sell the harvested data to vendors that sell cosmetic products. 74. The system according to claim 72 and/or any one or more other claims herein, wherein the system is configured to sell the harvested data to vendors that have similar customers to the customers that buy the system. 75. The system according to claim 74 and/or any one or more other claims herein, wherein the similarity between the similar customers is income level of each customer. 76. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to collect patient data and to perform and/or assist in the performance of a registry study. 77. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to notify patients who have received a microcoring
Docket No. CYT-014-PCT procedure performed using the system of an additional procedure that could be performed. 78. The system according to claim 77 and/or any one or more other claims herein, wherein the additional procedure comprises an additional microcoring procedure performed using the system. 79. The system according to claim 77 and/or any one or more other claims herein, wherein the additional procedure comprises a procedure performed using a product of a partner of the manufacturer of the system. 80. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to request and/or receive potential customer data. 81. The system according to claim 80 and/or any one or more other claims herein, wherein the potential customer data comprises data from vendors who sell cosmetic products. 82. The system according to claim 80 and/or any one or more other claims herein, wherein the potential customer data comprises data from vendors who have similar customers to the customers of the manufacturer of the system. 83. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to produce summary data reports. 84. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to upload IOT data. 85. The system according to claim 84 and/or any one or more other claims herein, wherein the IOT data is provided by a system component, such as the at least one treatment device. 86. The system according to claim 84 and/or any one or more other claims herein, wherein the IOT data is provided by a non-system device. 87. The system according to claim 84 and/or any one or more other claims herein, wherein the IOT data comprises microcoring treatment procedure data.
Docket No. CYT-014-PCT 88. The system according to claim 84 and/or any one or more other claims herein, wherein the system is configured to analyze the IOT data and produce an IOT analysis. 89. The system according to claim 88 and/or any one or more other claims herein, wherein the system comprises a patient device including a patient app, and wherein the system is configured to modify the patient app based on the IOT analysis. 90. The system according to claim 88 and/or any one or more other claims herein, wherein the system comprises a clinician device including a clinician app, and wherein the system is configured to modify the clinician app based on the IOT analysis. 91. The system according to claim 88 and/or any one or more other claims herein, wherein the system comprises a vendor device including a vendor app, and wherein the system is configured to modify the vendor app based on the IOT analysis. 92. The system according to claim 88 and/or any one or more other claims herein, wherein the system is configured to modify the at least one treatment device based on the IOT analysis. 93. The system according to claim 92 and/or any one or more other claims herein, wherein the system is configured to modify one or more settings used in a microcoring treatment procedure. 94. The system according to claim 88 and/or any one or more other claims herein, wherein the system is configured to produce information to send to a patient, and wherein the produced information is based on the IOT analysis. 95. The system according to claim 84 and/or any one or more other claims herein, wherein the system is configured to perform a microcoring procedure based on the uploaded IOT data.
Docket No. CYT-014-PCT 96. The system according to claim 84 and/or any one or more other claims herein, wherein the system is configured to perform a microcoring procedure in a closed loop arrangement based on the uploaded IOT data. 97. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to receive images of a patient prior to the performance of a microcoring procedure on the patient. 98. The system according to claim 97 and/or any one or more other claims herein, further comprising a camera configured to collect the pre-procedure patient images. 99. The system according to claim 97 and/or any one or more other claims herein, wherein the system comprises a patient device including a camera configured to collect the pre-procedure patient images. 100. The system according to claim 97 and/or any one or more other claims herein, wherein the system is further configured to produce a treatment plan based on the pre-procedure patient images. 101. The system according to claim 100 and/or any one or more other claims herein, wherein the treatment plan comprises proposed skin locations to be treated. 102. The system according to claim 97 and/or any one or more other claims herein, wherein the system is further configured to identity potential treatment issues based on the pre-procedure patient images. 103. The system according to claim 97 and/or any one or more other claims herein, wherein the system is configured to search for the pre-procedure patient images. 104. The system according to claim 103 and/or any one or more other claims herein, wherein the system is configured to search one or more social media sites for the pre-procedure patient images.
Docket No. CYT-014-PCT 105. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to receive images of a patient after the performance of a microcoring procedure on the patient. 106. The system according to claim 105 and/or any one or more other claims herein, wherein the system is further configured to monitor for an adverse condition based on the post-procedure patient images. 107. The system according to claim 105 and/or any one or more other claims herein, wherein the system is further configured to produce a post-microcoring procedure treatment plan and to monitor and suggest a change in the post- microcoring procedure treatment plan based on the post-procedure patient images. 108. The system according to claim 105 and/or any one or more other claims herein, wherein the system is configured to search for the post-procedure patient images. 109. The system according to claim 108 and/or any one or more other claims herein, wherein the system is configured to search one or more social media sites for the post-procedure patient images. 110. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to provide to the patient with a pre-microcoring procedure recommendation plan. 111. The system according to claim 110 and/or any one or more other claims herein, wherein the pre-microcoring recommendation plan is configured to optimize the outcome of a microcoring procedure for the patient. 112. The system according to claim 110 and/or any one or more other claims herein, wherein the pre-microcoring recommendation plan is based on one or more patient images.
Docket No. CYT-014-PCT 113. The system according to claim 110 and/or any one or more other claims herein, wherein the system is configured to automatically send out the pre-microcoring recommendation plan based on a schedule. 114. The system according to claim 110 and/or any one or more other claims herein, wherein the system is further configured to continue to send the pre- microcoring recommendation plan until a confirmation of receipt from the patient is received. 115. The system according to claim 110 and/or any one or more other claims herein, wherein the pre-microcoring recommendation plan comprises a recommended use of one or more cosmetic products. 116. The system according to claim 115 and/or any one or more other claims herein, wherein the system is configured to provide an automated web link to buy the one or more cosmetic products. 117. The system according to claim 115 and/or any one or more other claims herein, wherein the selection of the one or more cosmetic products is based on an input of a clinician. 118. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to send a patient a post-microcoring procedure recommendation plan for that patient. 119. The system according to claim 118 and/or any one or more other claims herein, wherein the post-microcoring recommendation plan is configured to optimize the outcome of a microcoring procedure for the patient. 120. The system according to claim 118 and/or any one or more other claims herein, wherein the post-microcoring recommendation plan is based on one or more patient images. 121. The system according to claim 120 and/or any one or more other claims herein, wherein the patient images comprise pre and/or post microcoring procedure patient images.
Docket No. CYT-014-PCT 122. The system according to claim 121 and/or any one or more other claims herein, wherein the patient images comprise pre and post microcoring procedure patient images. 123. The system according to claim 118 and/or any one or more other claims herein, wherein the system is further configured to continue to send the post- microcoring recommendation plan until a confirmation of receipt from the patient is received. 124. The system according to claim 118 and/or any one or more other claims herein, wherein the post-microcoring recommendation plan comprises a recommended use of one or more cosmetic products. 125. The system according to claim 124 and/or any one or more other claims herein, wherein the system is configured to provide an automated web link to buy the one or more cosmetic products. 126. The system according to claim 124 and/or any one or more other claims herein, wherein the selection of the one or more cosmetic products is based on an input of a clinician. 127. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to monitor patient browsing and produce browsing data. 128. The system according to claim 127 and/or any one or more other claims herein, wherein the system is further configured to produce a recommendation of a microcoring procedure based on the browsing data. 129. The system according to claim 127 and/or any one or more other claims herein, wherein the system is further configured to produce a recommendation of a complementary procedure to be performed based on the browsing data. 130. The system according to claim 127 and/or any one or more other claims herein, wherein the system is further configured to recommend the purchase of a third- party product based on the browsing data.
Docket No. CYT-014-PCT 131. The system according to claim 127 and/or any one or more other claims herein, wherein the system is further configured to recommend a clinician product and/or procedure based on the browsing data. 132. The system according to claim 1 and/or any one or more other claims herein, wherein the system comprises a member clinician login function. 133. The system according to claim 132 and/or any one or more other claims herein, wherein the system comprises one or more devices that are modified based on use by a first clinician that has logged into the member clinician function. 134. The system according to claim 133 and/or any one or more other claims herein, wherein the modifications comprise a bias toward preferences of the first clinician. 135. The system according to claim 132 and/or any one or more other claims herein, wherein the clinician login function comprises multiple levels of membership. 136. The system according to claim 135 and/or any one or more other claims herein, wherein the multiple levels of membership are related to multiple levels of preferences. 137. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to provide one or more recommendations to a clinician. 138. The system according to claim 137 and/or any one or more other claims herein, wherein the one or more recommendations comprise at least one recommendation to increase patient throughput for a clinician. 139. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to provide a discount to a patient, a clinician, and/or a vendor.
Docket No. CYT-014-PCT 140. The system according to claim 139 and/or any one or more other claims herein, wherein the system is configured to provide the discount based on the patient scheduling an appointment within a pre-determined timeframe. 141. The system according to claim 139 and/or any one or more other claims herein, wherein the system is configured to provide the discount based on the patient referring another patient. 142. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to receive a payment from a patient, a clinician, and/or a vendor. 143. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to make a payment to a clinician, a vendor, and/or a patient. 144. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to receive a payment from a vendor based on a product of that vendor being sold. 145. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to provide treatment data to a receiving component of the system and/or wherein the system is configured to receive treatment data from a transmitting component of the system. 146. The system according to claim 145 and/or any one or more other claims herein, wherein the receiving component and/or the transmitting component comprises one, two, or more devices selected from the group consisting of: one or more patient devices; one or more clinician devices; one or more vendor devices; and combinations thereof. 147. The system according to claim 145 and/or any one or more other claims herein, wherein the system is further configured to identify one or more of: movement of the at least one treatment device relative to the patient’s anatomy; smoothness of at least one treatment device movement; and/or detection of the
Docket No. CYT-014-PCT at least one treatment device treating the same anatomical location of the patient. 148. The system according to claim 145 and/or any one or more other claims herein, wherein the system is configured to: collect movement, position, and/or other data across multiple operators of the system; calculate population analytics to determine and identify operators that achieve and/or are likely to achieve optimized outcomes; and/or compare operator technique data of multiple operators such as to compare operators. 149. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to share data with one or more of: a clinician; a patient; a parent of a patient; and/or an information portal. 150. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to create one or more of: a community event; a training workshop such as an online training workshop; a consult, such as a virtual consult; and/or a virtual event. 151. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to offer post-operative care via an online marketplace. 152. The system according to claim 151 and/or any one or more other claims herein, wherein the system is configured to function as a broker between vendors, physicians, and/or patients. 153. The system according to claim 152 and/or any one or more other claims herein, wherein the system is configured to sell one or more add-on products to a patient. 154. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to allow a patient and/or other user of the system to transfer patient data to a social media platform.
Docket No. CYT-014-PCT 155. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to provide social media platform information to a patient or other user. 156. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to allow a clinician and/or a vendor to create advertising materials. 157. The system according to claim 156 and/or any one or more other claims herein, wherein the system further comprises a patient device, a server, and/or a network, and wherein the system is further configured to transmit the advertising materials to the patient device, the server, and/or the network. 158. The system according to claim 157 and/or any one or more other claims herein, wherein the system is configured to post the advertising materials on the patient device, on television and/or radio, and/or on a website. 159. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to provide references regarding one or more patients identified by the system as potential candidates for a microcoring or other procedure performed using the system. 160. The system according to claim 159 and/or any one or more other claims herein, wherein the one or more patients identified by the system are identified based on a prediction performed by the system that indicates the one or more patients are likely to achieve optimized or at least reasonable outcomes from the microcoring and/or other procedures to be performed using the system. 161. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to create and/or provide advertising of a promotional event and/or other event, wherein the promotional event and/or other event is associated with the use of the system. 162. The system according to claim 161 and/or any one or more other claims herein, wherein the system is configured to perform a function selected from the group consisting of: send a group email; provide information to a social media
Docket No. CYT-014-PCT platform; provide information on a patient device, a clinician device, and/or a vendor device; and combinations thereof. 163. The system according to claim 161 and/or any one or more other claims herein, wherein the system is configured to organize and/or otherwise cause to occur: one or more virtual events; one or more live events; or both. 164. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to allow a patient to enter a desired procedure into memory of the system, and the system is further configured to provide feedback to the patient. 165. The system according to claim 164 and/or any one or more other claims herein, wherein the feedback provided comprises: one or more system created predicted images of the patient approximating the appearance of the patient after the desired procedure is performed; an assessment of the appropriateness of the desired procedure for the patient; one or more alternative suggested procedures; and/or combinations of these. 166. The system according to claim 164 and/or any one or more other claims herein, wherein the system is configured to produce a three-dimensional selfie representing the current condition of the patient, and/or representing a predicted outcome of a microcoring, and/or other procedure performed on that patient using the system. 167. The system according to claim 166 and/or any one or more other claims herein, wherein the system produces the three-dimensional selfie by stitching multiple two-dimensional images, using augmented reality, or both. 168. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to provide a clinician suggestion to a patient, wherein the clinician suggestion comprises a recommendation of a particular clinician type or a particular clinician.
Docket No. CYT-014-PCT 169. The system according to claim 168 and/or any one or more other claims herein, wherein the system determines the clinician suggestion based on patient data and/or clinician data. 170. The system according to claim 169 and/or any one or more other claims herein, wherein the patient data and/or clinician data comprises data selected from the group consisting of: patient images; patient desired outcomes data; patient physiologic data; patient location data; patient demographic data; patient financial data; clinician performance data; clinician skill level data; clinician office location data; clinician available techniques and/or equipment data; and combinations thereof. 171. The system according to claim 168 and/or any one or more other claims herein, wherein the system is configured to determine the clinician suggestion based on an analysis of a set of multiple clinicians, wherein the analysis identifies clinicians that have treated the highest quantity of similar profile patients. 172. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to harvest data to perform a registry study. 173. The system according to claim 172 and/or any one or more other claims herein, wherein the system is configured to reduce the complexity of the patient- consenting process. 174. The system according to claim 172 and/or any one or more other claims herein, wherein the system is configured to support and/or enhance enrollment of patients from multiple clinical practices into a multi-site study. 175. The system according to claim 172 and/or any one or more other claims herein, wherein the system is configured to provide collaborative clinical study tools. 176. The system according to claim 175 and/or any one or more other claims herein, wherein the system is configured to provide an automated creation of documents for submittal to an internal review board. 177. The system according to claim 1 and/or any one or more other claims herein, wherein the at least one treatment device further comprises a functional element
Docket No. CYT-014-PCT comprising: one or more sensors; one or more transducers; and/or one or more other components. 178. The system according to claim 177 and/or any one or more other claims herein, wherein the functional element comprises one or more transducers configured to provide tactile feedback to an operator. 179. The system according to claim 178 and/or any one or more other claims herein, wherein the tactile feedback is configured to cause the operator to better hold and/or better position the at least one treatment device during microcoring. 180. The system according to claim 178 and/or any one or more other claims herein, wherein the functional element further comprises one or more accelerometers and/or one or more other sensors configured to track movement and/or position of the at least one treatment device. 181. The system according to claim 1 and/or any one or more other claims herein, wherein the system further comprises a skin modification device. 182. The system according to claim 181 and/or any one or more other claims herein, wherein the skin modification device comprises one, two, or more products selected from the group consisting of: hyaluronic acid; a moisturizer; an analgesic; a peptide; exosomes; platelet-rich plasma (PRP); arnica montana extract; a vasoconstrictor; methotrexate; minoxidil; stem cells; botulinum toxin; a corticosteroid; and combinations thereof.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202363604378P | 2023-11-30 | 2023-11-30 | |
| US63/604,378 | 2023-11-30 | ||
| US202463666978P | 2024-07-02 | 2024-07-02 | |
| US63/666,978 | 2024-07-02 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2025117876A1 true WO2025117876A1 (en) | 2025-06-05 |
Family
ID=95898218
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2024/057944 Pending WO2025117876A1 (en) | 2023-11-30 | 2024-11-29 | Skin treatment systems, devices, and methods |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2025117876A1 (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20180078278A1 (en) * | 2016-09-21 | 2018-03-22 | Cytrellis Biosystems, Inc. | Rapid skin treatment using microcoring |
| US20220184364A1 (en) * | 2016-08-24 | 2022-06-16 | Fk Irons Inc. | Pen style microneedling machine apparatus |
| US20220211424A1 (en) * | 2018-10-23 | 2022-07-07 | Aesthetics Biomedical, Inc. | Methods, devices and systems for inducing collagen regeneration |
-
2024
- 2024-11-29 WO PCT/US2024/057944 patent/WO2025117876A1/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20220184364A1 (en) * | 2016-08-24 | 2022-06-16 | Fk Irons Inc. | Pen style microneedling machine apparatus |
| US20180078278A1 (en) * | 2016-09-21 | 2018-03-22 | Cytrellis Biosystems, Inc. | Rapid skin treatment using microcoring |
| US20200246039A1 (en) * | 2016-09-21 | 2020-08-06 | Cytrellis Biosystems, Inc. | Rapid skin treatment using microcoring |
| US20220211424A1 (en) * | 2018-10-23 | 2022-07-07 | Aesthetics Biomedical, Inc. | Methods, devices and systems for inducing collagen regeneration |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| AU2025234164B2 (en) | Data processing system for generating predictions of cognitive outcome in patients | |
| US12471996B2 (en) | Extended intelligence for pulmonary procedures | |
| EP3684248B1 (en) | Method and apparatus for determining health status | |
| Friedman et al. | Treatment of atrophic facial acne scars with the 1064-nm Q-switched Nd: YAG laser: six-month follow-up study | |
| CN102112059B (en) | System and method for cosmetic treatment and imaging | |
| EP2346428B1 (en) | Treatment planning systems and methods for body contouring applications | |
| US20240252200A1 (en) | Skin treatment systems and methods | |
| US20050267347A1 (en) | Deep brain stimulation | |
| US20250359887A1 (en) | Skin treatment systems, devices and methods | |
| WO2025096927A1 (en) | Skin treatment systems, devices and methods | |
| TW202100099A (en) | Devices, systems and methods for tissue analysis, location determination and therapy thereof using optical radiation | |
| WO2025117876A1 (en) | Skin treatment systems, devices, and methods | |
| US20230355106A1 (en) | Predicting Vessel Compliance Responsive to Multiple Potential Treatments | |
| Stein et al. | Creating 3D gelatin phantoms for experimental evaluation in biomedicine | |
| Cetin et al. | Bone ablation using a ho: Yag laser | |
| US20250166830A1 (en) | Collection of user choices and resulting outcomes from surgeries to provide weighted suggestions for future decisions | |
| US20250366899A1 (en) | Generator and catheter for tissue ablation | |
| Liu et al. | Research on bedside hemodialysis AVF puncture robot method based on biomechanical models | |
| Strehlow et al. | US-tracked steered FUS in a respiratory ex vivo ovine liver phantom | |
| Drobek et al. | Tomographic particle image velocimetry of a water-jet for low volume harvesting of fat tissue for regenerative medicine | |
| JP2024091345A (en) | Treatment audit system | |
| Viana Beserra | Tools for Focused Ultrasound Treatment Planning | |
| Sauter et al. | Risk management for medical devices in research projects | |
| JP2024091347A (en) | Treatment audit system | |
| Jauer et al. | GPU-based real-time generation of large ultrasound volumes from freehand 3D sweeps |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 24898844 Country of ref document: EP Kind code of ref document: A1 |