WO2025264906A1

WO2025264906A1 - Devices, systems, and methods for monitoring injection, infusion, or insertion site suitability

Info

Publication number: WO2025264906A1
Application number: PCT/US2025/034346
Authority: WO
Inventors: Kent M. MANSON; Marie K. SCHILLER
Original assignee: Locasana Inc
Current assignee: Locasana Inc
Priority date: 2024-06-19
Filing date: 2025-06-19
Publication date: 2025-12-26
Anticipated expiration: 2026-12-19

Abstract

A monitoring device includes a housing, a sensor, and a controller. The housing has a contact surface configured to contact a target location. The sensor is within the housing and includes an emitter and a detector. The controller includes a processor and a memory and is operably coupled to the sensor and an input device. The controller can execute a set of operations to assess a suitability of the target location for a medical use including any of subcutaneous drug delivery or continuous analyte measurement. The operations includes receiving an input associated with the medical use; causing the emitter to produce an emitted signal from the contact surface towards the target location; receiving from the detector a received signal from the target location: and producing, based on the input and the received signal, an indication associated with the suitability of the target location for the medical use.

Description

DEVICES, SYSTEMS, AND METHODS FOR MONITORING INJECTION, INFUSION, OR INSERTION SITE SUITABILITY

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority to and the filing date benefit of U.S. Provisional Application No. 63/661,834, entitled “Devices, Systems, and Methods for Identifying, Staging, Marking, and/or Monitoring Epidermis, Dermis, and/or Hypodermis Insertion. Infusion, and/or Injection Site Viability,” filed June 19. 2024, which is incorporated herein by reference in its entirety.

BACKGROUND

[0002] The embodiments described herein generally relate to devices, systems, and methods to identify, stage, mark, and/or monitor acute and chronic epidermal, dermal, and hypodermal and/or subcutaneous insertion, infusion, and/or injection site suitability. In particular, devices, systems, and methods described herein can be suitable to identify, stage, mark, and/or monitor the level of unfavorable factors present such as, for example, epidermal allergic reactions, infection, and/or lipodystrophy (including lipoatrophy and lipohypertrophy). These factors are known to occur in varying degrees in people who chronically wear on-body monitoring devices, typically with an adhesive with or without an inserted sensor, and/or people who chronically inject or infuse medications..

[0003] Within the sphere of injection and infusion medication delivery and continuous monitoring, with or without an insertion, the occurrence of adverse events is a recognized phenomenon. These events can manifest when medications are chronically administered through subcutaneous injections or continuous subcutaneous infusions, or when individuals wear body -worn delivery and monitoring systems featuring adhesive patches, often with embedded sensors or cannula that penetrate the dermal and/or subcutaneous tissue. These w ell- established adverse events can arise due to a diverse set of factors, including the nature of materials used, degradation products of the active ingredients or the active ingredient itself, injection frequency, wear duration, excipients, needle length and properties, body mass index, site location, rotation practices, therapy duration, level of disease control, and individual skin characteristics. In many instances, the precise mechanisms or causes of such adverse reactions remains elusive or likely results from a multifaceted interplay of factors.

[0004] Prominently, individuals with diabetes requiring chronic injections and/or infusions are particularly susceptible to cutaneous and subcutaneous adverse skin reactions, with lipohypertrophy being a prevalent and concerning condition. Lipohypertrophy is the stage in which excess fat accumulates over time forming lumps under the skin at insulin injection and infusion sites. Known therapies for diabetes include, but are not limited to, glucagon-like peptide agonists, dual agonists, triple agonists, and insulin. In particular, insulin therapy has been shown to cause a distinct inflammatory response caused by a combination of acute injury, active ingredients, biproducts, and/or preservatives. Over time, in some patients, sites become compromised as the skin begins to atrophy and become fibrotic, which results in insulin absorption being compromised. The reduction in insulin absorption can lead to significant levels of glycemic variability because of the timing and consistency of the insulin absorption is affected. The issues with lipohypertrophy are expected to increase as more people are using injections and because more people with diabetes requiring insulin are using continuous insulin infusion with systems that can remain in use for longer durations of time (e.g., up to 7 days versus previously typical standards of up to 3 days).

[0005] Known methods for diagnosing lipohypertrophy rely on manual palpation, which is a tactile examination performed during a physical evaluation. Such methods are often able identify only late-stage deterioration, where the site is too compromised to be used for effective injection or infusion. Once detected, the standard treatment protocol includes advising patients to rotate sites but, given the limitation of sites, this is often a treatment guideline that cannot be implemented. Typically, this guidance is delivered through verbal or written communication with no system in place for continuous patient alerts or remote monitoring.

[0006] Ultrasound is emerging as an additional method to detect lipohypertrophy and likely offers advantages over manual palpation as it provides the opportunity to detect lipohypertrophy at early stages that might be missed by palpation. However, very few endocrinologists are trained in ultrasound technology, creating large barriers to adoption. Moreover, current methods using ultrasound do not provide at-home, real-time assessments and feedback to patients.

[0007] Cutaneous issues are frequent with chronic injections and infusions. The symptoms felt by patients include itching, pain, bruising, swelling, and redness and the time to resolve varies. Currently, there is no known way to determine the cause and identification of the reaction, thus patients typically just wait for symptoms to resolve. In some instances, how ever, these symptoms could be indicative of a subcutaneous issue, which, because known systems and methods are not conducive to an at-home, real-time assessment, will often go untreated [0008] In addition to injections and infusions, many people with diabetes are now using a continuous glucose monitoring (CGM) system which is attached to the epidermis via an adhesive patch and inserted into the subcutaneous tissue. Others in development will be inserted into the dermis or implanted. The use of CGMs can cause cutaneous and subcutaneous issues although less information is available on the long-term effects.

[0009] A need therefore exists for an at-home system operable to evaluate, monitor, and/or mark the suitability of target locations for injection, infusion, and/or insertion.

SUMMARY

[0010] In some embodiments, a monitoring device includes a housing, a sensor, and a controller. The housing has a contact surface configured to contact a target location. The sensor is at least partially within the housing and includes an emitter and a detector. The controller includes a processor and a memory and is operably coupled to the sensor and an input device. The controller can execute a set of operations to assess a suitability’ of the target location for a medical use including any of subcutaneous drug delivery' or continuous analyte measurement. The set of operations includes receiving an input associated with the medical use; causing the emitter to produce an emitted signal from the contact surface towards the target location; receiving from the detector a received signal from the target location; and producing, based on the input and the received signal, an indication associated with the suitability' of the target location for the medical use.

[0011] In some embodiments, the input includes a body portion (e.g., the abdomen, buttocks, thigh, arm, etc.) associated with the target location. In some embodiments, the input includes a characteristic of a patient.

[0012] In some embodiments, the input includes any of a drug for subcutaneous drug delivery, a dosage of the drug, a delivery' mechanism, or a characteristic of a needle or cannula through which the drug is delivered.

[0013] In some embodiments, the received signal is associated with any of a structural tissue property associated with the target location, a mechanical tissue property associated with the target location, an optical tissue property' associated with the target location, a physiological tissue property associated with the target location, or thermal tissue property associated with the target location. [0014] In some embodiments, the sensor is a bioelectrical impedance sensor and the structural tissue property is associated with an impedance associated with the target location.

[0015] In some embodiments, the sensor is an elastography sensor and the mechanical tissue property is associated with a viscoelastic characteristic associated with the target location.

[0016] In some embodiments, the sensor is an optical sensor. The emitter of the optical sensor includes a light source, the emitted signal is an emitted light signal, and the detector of the optical sensor is a photodetector. The optical tissue property is associated with any of an absorption of the emitted light signal or a scattering of the emitted light signal.

[0017] In some embodiments, the sensor is a first sensor of a set of sensors at least partially within the housing. The first sensor is any of a bioelectrical impedance sensor, an elastography sensor, an optical sensor, or a temperature sensor. The set of sensors includes a second sensor that is any other of the bioelectrical impedance sensor, the elastography sensor, the optical sensor, or the temperature sensor. The producing the indication associated with the suitability of the target location for the medical use includes: determining a first sensor factor associated with the received signal from the first sensor and a second sensor factor associated with the received signal from the second sensor; determining a suitability factor based on the input, the first sensor factor, and the second sensor factor; and producing the indication on a condition that the suitability' factor is within a suitability threshold.

[0018] In some embodiments, the indication is a first indication, the suitability threshold is a first suitability⁷ threshold, and the set of operations further includes producing a second indication on a condition that the suitability factor is within a second suitability⁷ threshold. In some embodiments, the set of operations further includes producing a third indication on a condition that the suitability factor is outside of at least one of the first suitability threshold or the second suitability⁷ threshold.

[0019] In some embodiments, the monitoring device further includes a force sensor operably coupled to the contact surface. The force sensor is configured to produce a force signal associated with a contact force exerted on the contact surface. The set of operations further includes producing an error code on a condition that the force signal is outside of a contact force threshold. [0020] In some embodiments, the monitoring device further includes a temperature sensor operably coupled to the contact surface. The temperature sensor is configured to produce a temperature signal associated with the target location. The set of operations further includes producing an error code on a condition that the temperature signal is outside of a contact temperature threshold.

[0021] In some embodiments, the monitoring device further includes a marking element within the housing. The set of operations further includes marking the target locations on a condition that the suitability factor is within the suitability threshold.

[0022] In some embodiments, a monitoring device includes a housing, a first sensor, a second sensor, and a controller. The housing has a contact surface configured to contact a target location. The first sensor is at least partially within the housing and is any of a bioelectrical impedance sensor, an elastography sensor, an optical sensor, or a temperature sensor. The second sensor is at least partially within the housing and is different from the first sensor. The second sensor is another of the bioelectrical impedance sensor, the elastography sensor, the optical sensor, or the temperature sensor. The controller includes a processor and a memory' and is operably coupled to the first sensor and the second sensor. The controller is configured to execute a plurality of operations to assess a suitability of the target location for a medical use including any of subcutaneous drug delivery or continuous analyte measurement. The plurality' of operations includes: receiving an input associated with the medical use; receiving a first signal from the first sensor; receiving a second signal from the second sensor; determining a first sensor factor associated with the first signal and a second sensor factor associated with the second signal; determining a suitability factor based on the input, the first sensor factor, and the second sensor factor; and producing an indication on a condition that the suitability factor is within a suitability threshold associated with the suitability of the target location for the medical use.

[0023] In some embodiments, a method of assessing a suitability of a target location for a medical use is performed with a handheld monitoring device. The handheld monitoring device includes a housing, a sensor, and a controller. The medical use includes any of subcutaneous drug delivery or continuous analyte measurement. The method includes receiving, via a communication module implemented in at least one of a memory or a processing device of the controller, an input associated with the medical use. The method includes receiving, via a sensor module implemented in at least one of the memory' or the processing device of the controller, a signal from the sensor, the signal associated with the target location. A suitability factor is determined based on the input and the signal. The method includes producing, via an output module implemented in at least one of the memory or the processing device of the controller, an indication on a condition that the suitability factor is within a suitability threshold associated with the suitability of the target location for the medical use.

[0024] In some embodiments, the input includes any of an identification of a body portion associated with the target location or a characteristic of a patient associated with the target location.

[0025] In some embodiments, the input includes a prior suitability assessment associated with the target location.

[0026] In some embodiments, the input includes any of a drug for subcutaneous drug delivery, a dosage of the drug, a delivery mechanism, or a characteristic of a needle or cannula through which the drug is delivered.

[0027] In some embodiments, a non-transitory processor-readable medium storing code representing instructions is to be executed by a processor of a handheld monitoring device. The handheld monitoring device includes a housing, a first sensor, and a second sensor. The code comprises code to cause the processor to receive an input associated with a medical use; receive a first signal from the first sensor, the first signal associated with a target location of a body; receive a second signal from the second sensor, the second signal associated with the target location of the body; determine a suitability factor of the target location based on the input, the first sensor factor, and the second sensor factor; and produce an indication on a condition that the suitability factor is within a suitability threshold associated with the suitability’ of the target location for the medical use.

[0028] In some embodiments, a method of assessing a suitability of a target location for a medical use is performed w ith a handheld monitoring device. The handheld monitoring device includes a housing, a sensor, and a controller. The method includes inputting an input parameter associated with a medical use. A contact surface of the handheld monitoring device is placed against a target location of a body. The handheld monitoring device is actuated to cause the device to produce an emitted signal from the contact surface towards the target location; receive, via the sensor, a received signal from the target location; and produce, based on the input and the received signal, an indication associated with the suitability of the target location for the medical use.

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] FIG. 1 is a schematic illustration of a system with for assessing suitability of a target location, according to an embodiment.

[0030] FIG. 2 is a schematic illustration of a handheld monitoring device of the system shown in FIG. 1.

[0031] FIG. 3 is a schematic illustration of a controller of the handheld monitoring device shown in FIG. 2.

[0032] FIG. 4 is a flow chart of a method for assessing the suitability of a target location for a medical use, according to an embodiment.

[0033] FIGS. 5-7 are a side view (FIG. 5). a top view (FIG. 6) and a bottom view (FIG. 7) of a handheld monitoring device, according to an embodiment.

[0034] FIG. 8 is a bottom view of a handheld monitoring device, according to an embodiment.

DETAILED DESCRIPTION

[0035] Generally, the present disclosure is directed to handheld devices and methods designed to assess the suitability of a target location of the body for a medical use, such as application of a delivery device (e.g., atransdermal patch), insertion, injection, and/or infusion. The embodiments described herein can be used by the patient and/or their caregiver at any suitable time or interval, such as at the time the patient is ready to initiate the medical action (e.g.. applying an on-body delivery device or administering an insulin injection) or at a defined period of time before or after the medical action is taken. The embodiments described herein are non-invasive, easily operated, intuitive, and can provide accurate feedback to improve the efficacy of the medical action. Further, the devices described herein can be battery powered, allowing the assessment to be performed without A/C power, and at any suitable location (e.g., outside of a laboratory and/or at any suitable “point of care,” such as the patient’s home). [0036] The embodiments described herein include devices that can be used in conjunction with other medical devices to improve the efficacy of the medical action(s) undertaken with the medical devices. In particular, the devices described herein are not integral with or dependent on any other devices. For example, the devices described herein can be used in connection with any insulin delivery' device to improve the efficacy of the insulin delivered, and are not integrated with or limited to any specific insulin delivery device.

[0037] The factors affecting the suitability of a site for medical use are complex and are based on a variety' of factors, including characteristics of the patient’s tissue (e.g., tissue’s physiological, mechanical, and structural properties), parameters that are unique to the patient (e.g.. the patient’s age, the patient’s height and weight, the patient’s gender), as well as the type of medical use intended. For example, tissue locations characterized by properties indicative of healthy, non-pathological tissue generally have a high suitability' for medical use. Such highly suitable locations include tissue characterized by robust blood perfusion and oxygenation, and a temperature within the normal physiological range. Conversely, tissue characterized by high mechanical stiffness, poor compliance, and reduced blood perfusion (which can be caused by lipohypertrophy or fibrosis) is generally not suitable for medical uses. Moreover, a target location that is devoid of lipohypertrophy or fibrosis, but which has a thin subcutaneous fat layer, although potentially suitable for certain medical uses, may be unsuitable for other uses, such as the delivery of insulin. Specifically, because delivery' of insulin intramuscularly can produce significant adverse effects (e.g. hypoglycemia), a target location having a thin subcutaneous fat layer (e.g., due to the patient’s underlying low body mass index or cause by lipoatrophy) may not be suitable for that specified medical use. Accordingly, details about the specific medical use, and even factors such as the needle length, are relevant to establish an accurate, actionable identification of suitability.

[0038] The handheld devices described herein advantageously produce an indication of suitability of a target location based on a multi-parametric assessment of the functional capacity of a target location to support a medical use or action (such as subcutaneous drug delivery or continuous analyte monitoring). The devices and methods described herein also receive information associated with the patient. For example, the devices and methods enable additional interfaces, such as web portals or Electronic Health Record (EHR) integrations, for access by healthcare providers or caregivers. In this manner, the devices and methods described herein provide for effective, tailored determination of site suitability' based not only⁷ sensor and suitability data, but also demographic variables such as user age and skin color, and other clinical data received from user-input or other sources.

[0039] In some embodiments, the devices and methods described herein can assess the suitability' of a target location for a medical use based on a desired physiological function of the target location. Similarly stated, the devices and methods described herein can produce an indication on a condition that the target location is characterized by robust blood perfusion and oxygenation, and a temperature within the normal physiological range.

[0040] In some embodiments, the devices and methods described herein can assess the suitability of a target location for a medical use based on desired mechanical properties of the target location. Similarly stated, the devices and methods described herein can produce an indication on a condition that the target location is characterized by high elasticity and compliance (low stiffness), which can indicate an absence of fibrosis or dense tissue associated with lipohypertrophy.

[0041] In some embodiments, the devices and methods described herein can assess the suitability of a target location for a medical use based on desired structural properties of the target location. Similarly stated, the devices and methods described herein can produce an indication on a condition that the target location exhibits characteristics known to interfere with drug absorption or sensor accuracy (e.g., inflammation, lipoatrophy, fibrosis).

[0042] The devices and methods described herein can also facilitate the evaluation of multiple different target locations to develop a suitability map of a region or area of interest (e.g., the patient’s abdomen). In addition to assessing the suitability of a site, the devices and methods described herein can also identify those target locations that are suitable for use and those that require improvements in suitability before using, offering a significant advance in the field of diagnostic tools and their application.

[0043] In some embodiments, a handheld device for assessing a suitability of a tissue site includes a housing, at least two sensors utilizing different sensing modalities (e.g., optical, bioelectrical impedance, mechanical, thermal), a processor, and a non-transitory computer- readable medium. The non-transitory computer-readable medium includes stored instructions that, when executed, cause the processor to process sensor data to determine a suitability status or map of the tissue site and provide an output to the user. [0044] In some embodiments, a method for assessing and/or managing the suitability of a tissue site includes receiving, at a processor of a handheld device, sensor data from multiple modalities and historical data. The method further includes processing the data by performing a multiscale analysis. This analysis determines local tissue properties from which a macroscopic suitability map can be generated. The method includes generating multiple outputs, which may include a suitability classification, a pathology score, and a recommended user action.

[0045] In other embodiments, a system for monitoring tissue site health includes a handheld device communicatively coupled to an external computing device. The external device is configured to receive, display, and store suitability data, enabling long-term monitoring and trend analysis.

[0046] As used herein, the term “about'’ when used in connection with a referenced numeric indication means the referenced numeric indication plus or minus up to 10 percent of that referenced numeric indication unless otherwise described herein. For example, the language “about 50” covers the range of 45 to 55. Similarly, the language “about 5” covers the range of 4.5 to 5.5.

[0047] As used in this specification and the appended claims, the word “distal” refers to direction towards a work site, and the word “proximal” refers to a direction away from the work site. Thus, for example, the end of a medical device that is closest to the target tissue would be the distal end of the medical device, and the end opposite the distal end (i.e. , the end manipulated by the user) would be the proximal end of the medical device.

[0048] Further, specific words chosen to describe one or more embodiments and optional elements or features are not intended to limit the invention. For example, spatially relative terms — such as “beneath”, “below”, “lower”, “above”, “upper”, “proximal”, “distal”, and the like — may be used to describe the relationship of one element or feature to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions (i.e., translational placements) and orientations (i.e., rotational placements) of a device in use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be “above” or “over” the other elements or features. Thus, the term “below” can encompass both positions and orientations of above and below. A device may be otherwise oriented (e.g., rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Likewise, descriptions of movement along (translation) and around (rotation) various axes include various spatial positions and orientations. The combination of a body’s position and orientation defines the body’s pose.

[0049] Similarly, geometric terms, such as “parallel”, "perpendicular", "round", or “square”, are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow⁷ for variations due to manufacturing or equivalent functions. For example, if an element is described as “round” or “generally round,” a component that is not precisely circular (e.g., one that is slightly oblong or is a many-sided polygon) is still encompassed by this description.

[0050] In addition, the singular forms “a”, “an”, and “the” are intended to include the plural forms as well, unless the context indicates otherwise. The terms “comprises”, “includes”, “has”, and the like specify the presence of stated features, steps, operations, elements, components, etc. but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, or groups.

[0051] FIG. 1 is a schematic illustration of a system 1000 for assessing the suitability of a target location of a patient P for a medical use, according to an embodiment. The system 1000 includes a monitoring device 1100, which can be a handheld electromechanical device that evaluates the tissue (e.g.. the skin and/or subcutaneous tissue) associated with a target location of the patient P and produces indications of the suitability of the target location for the desired medical use. The medical use can be, for example, subcutaneous drug delivery (e.g., via a transdermal patch, an on-body infusion device, a pen injector, an autoinjector, or implantation of a dosage form) or continuous analyte measurement (e.g., via a continuous glucose monitor). The target location can be any portion of the body that is suitable for the desired medical use. such as, for example, the abdomen, thigh, arm, and buttocks.

[0052] The system 1000 can optionally include an external computing device 1250 that is operably coupled to the monitoring device 1100 (e.g., via a wired or wireless connection). The external computing device 1250 can a smart phone, a tablet, or other device to transmit, receive, and/or process information in accordance with the methods described herein. In some embodiments, the monitoring device 1100 can transmit data to and/or receive data from a medical application 1260 that is on or supported by the external computing device 1250. For example, as described herein, a user can provide input associated with the medical use via the medical application 1260, which can then be transmitted to the monitoring device 1100 (i.e., received by a controller of the monitoring device 1100) to facilitate the assessment of the target location. The medical application may also receive input from sensors within the external computing device 1250 (e.g., user-captured images, accelerometers) or from other external sensors 1270 (e.g.. an external temperature sensor, a glucose meter, or the like). For example, in some embodiments, the external computing device 1250 can receive information from a medical device (e.g., a glucose monitor, a pen injector, or an on-body infusion pump) that is associated with the medical use. The medical application 1260 can process the received information and then transmit such information to controller of the monitoring device 1100. For example, in some embodiments, the external computing device 1250 can receive information from a drug delivery device that is associated with the type of drug (e.g., insulin, a specific composition of glucagon-like peptide-1 (GLP-1) agonists), the type of delivery (e.g., injection, slow bolus delivery, etc.), a length of the needle or cannula through which the drug will be delivered, an amount of the drug to be delivered). The medical application 1260 can optionally process this information and the transmit the information as input to the monitoring device 1100 to facilitate an accurate assessment of the target location for the intended medical use or action.

[0053] In some embodiments, the external computing device 1250 can be coupled via a network 1290 to a health care provider (HCP) device 1295 or other interface having potentially relevant information (e.g., insurer's device). In this manner, the medical application 1260 can securely share data through wi-fi, cellular or other means to the cloud / storage infrastructure (e.g., the HCP device 1295) to enable additional web, mobile, electronic health records (EHR), or other interfaces for healthcare providers, caregivers, insurers, or other appropriate entities to access the information. The network 1290 can be a piconet, the Internet, an intranet, a local area network (LAN), a wide area network (WAN), a virtual network, a telecommunications network, any other suitable communication system and/or combination of such networks. The network 1290 can be implemented as a wired and/or wireless network

[0054] Referring to FIG. 2, the monitoring device 1100 includes a housing 1110, a first sensor 1310, a controller 1200. and an output assembly 1230. The monitoring device 1100 can optionally include an on-board power supply 1150 within the housing 1110, additional sensors (e.g., a second sensor 1320, as shown in FIG. 2), and a marking element 1160.

[0055] The housing 1110 can be any structure that contains and/or supports the components of the monitoring device (e.g., the controller 1200 and the sensors). In some embodiments, the monitoring device 1100 has a size, shape and/or weight such that the device can be held, used and/or manipulated in a user’s hands (i.e., it can be a '‘handheld” device). In other embodiments, the monitoring device 1100 can be a self-contained device that has an overall volume of less than about 330 cm³ (or about 20 cubic inches). The housing 1110 includes a user interface portion (not identified), a grip portion (not identified) and a contact surface 1120. The user interface portion can be accessible and/or viewable by a user and can provide the structure for mounting various user input / output features, such as a power switch 1151, an activation button 1152, and an output assembly 1230. The user interface portion can be located on a top portion of the housing 1110 (i.e., opposite the contact surface 1120) to allow- for easy viewing and use by the user.

[0056] The output assembly 1230 can be any device, mechanism, or arrangement of components suitable for producing an indication to the user. For example, in some embodiments, the output assembly 1230 can include a light output device that produces a visual indication, such as, a light-emitting diode (LEDs), a liquid-crystal display (LCD) screen, fiber optic components or the like. In this manner, the monitoring device 1100 can produce a light indication associated with the suitability⁷ of a target location (e.g., a red light output for an unsuitable location, a yellow light output for a marginally suitable location, and a green light output for a suitable location). In some embodiments, the output assembly 1230 can include any suitable device for producing sound, such as a micro-speaker, a piezo-electric transducer or the like. In this manner, the monitoring device 1100 can produce an audible indication associated with the suitability⁷ of a target location (e.g., a rapid series of beeps for an unsuitable location, a softer, lower frequency series of beeps for a marginally suitable location, and a chime for a suitable location). In other embodiments, the output assembly 1230 can include a haptic output device.

[0057] The controller 1200 can be any suitable computing device or set of devices to perform the functions described herein. Referring to FIG. 3, the controller 1200 includes a processor 1210, a memory^ 1211, and is operatively^ coupled to (or includes) a wireless communications interface 1220 (FIG. 2). The controller 1200 also optionally includes an input/output module 1215, a sensor module 1212, a suitability assessment module 1214, and a mapping module 1213. Although shown as including each of the input/output module 1215, the sensor module 1212, the assessment module 1214, and the mapping module 1213, in other embodiments, the controller 1200 need not include all (or any) of these modules. Moreover, although shown as including a series of components within one device, in other embodiments, the controller 1200 can include certain portions in one device (and at one location) and other portions in another device (and at another location). For example, in some embodiments, the controller 1200 can include a sensor module 1212 within the monitoring device and the assessment module 1214) in a second, separate device that is remotely located.

[0058] The processor 1210, and any of the processors described herein, can be any suitable processor for performing the methods described herein. In some embodiments, processor 1210 can be configured to run and/or execute application modules, processes and/or functions associated with the controller 1200. For example, the processor 1210 can be configured to run and/or execute each of the input/output module 1215, the sensor module 1212, the assessment module 1214, the mapping module 1213, and/or any of the other modules described herein, and perform the methods associated therewith. The processor 1210 can be, for example, a Field Programmable Gate Array (FPGA), an Application Specific Integrated Circuit (ASIC), a Digital Signal Processor (DSP), and/or the like. The processor 1210 can be configured to retrieve data from and/or write data to memory, e.g.. the memory 1211. In some embodiments, the processor 1210 can cooperatively function with the wireless communications interface 1220 and/or execute instructions from code to provide signals to communicatively couple the controller 1200 to the external computing device 1250.

[0059] The memory 1211 is also referred to as a non-transitory computer-readable medium, which can include instructions or computer code for performing various computer- implemented operations. The computer-readable medium (or processor-readable medium) is non-transitory in the sense that it does not include transitory propagating signals per se (e.g.. a propagating electromagnetic wave carrying information on a transmission medium such as space or a cable). The media and computer code (also can be referred to as code) may be those designed and constructed for the specific purpose or purposes. Examples of non-transitory computer-readable media include, but are not limited to magnetic storage media such as hard disks, floppy disks, and magnetic tape; optical storage media such as Compact Disc/Digital Video Discs (CD/DVDs), Compact Disc-Read Only Memories (CD-ROMs), and holographic devices; magneto-optical storage media such as optical disks; carrier wave signal processing modules. Read-Only Memory (ROM), Random-Access Memory (RAM) and/or the like. One or more processors can be communicatively coupled to the memory and operable to execute the code stored on the non-transitory processor-readable medium. Examples of processors include general purpose processors (e.g., CPUs), Graphical Processing Units, Field Programmable Gate Arrays (FPGAs), Application Specific Integrated Circuits (ASICs), Digital Signal Processor (DSPs). Programmable Logic Devices (PLDs). and the like. Examples of computer code include, but are not limited to, micro-code or micro-instructions, machine instructions, such as produced by a compiler, code used to produce a web service, and files containing higher-level instructions that are executed by a computer using an interpreter. For example, embodiments may be implemented using imperative programming languages (e.g., C, Fortran, etc.), functional programming languages (Haskell, Erlang, etc.), logical programming languages (e.g., Prolog), object-oriented programming languages (e.g., Java, C++, etc.) or other suitable programming languages and/or development tools. Additional examples of computer code include, but are not limited to. control signals, encrypted code, and compressed code. In some embodiments, the memory 1211 stores instructions to cause the processor 1210 to execute modules, processes and/or functions associated with the controller 1200.

[0060] The input / output module 1215 can be a hardware and/or software module (stored in memory 1211 and/or executed in the processor 1210). The input / output module 1215 is configured to receive one or more inputs related to a medical use (e.g., an infusion or injection) and produce one or more outputs (e.g., indications, error codes, control signals, or the like) to facilitate determining the suitability of a target location for the desired medical use and conveying such information to a user. The input / output module 1215 can receive the inputs in any suitable manner. For example, in some embodiments, the input / output module 1215 can receive one or more inputs in response to an input prompt displayed or prompted from user input / output features of the monitoring device 1100 (e.g., via the power switch 1151, the activation button 1 152, or other input features). For example, in some embodiments, inputs related to a body portion associated with the target location (e.g., abdomen, thigh, buttocks, arm), a characteristic of the patient (e.g., the patient’s age, height, weight, or gender), an identification of the medical action (e.g., infusion, injection, monitoring), and characteristics of the medical action (e.g.. an identification of the drug to be delivered, a dosage of the drug, a time period for delivery of the drug, a characteristic of the needle or cannula through which the drug will be delivered) can be entered in response to prompts produced from the monitoring device. In other embodiments, the input / output module 1215 can receive one or more of these inputs from the external computing device 1250.

[0061] The sensor module 1212 can be a hardware and/or software module (stored in memory 1211 and/or executed in the processor 1210). In some embodiments, the sensor module 1212 can cause any of the sensors in the monitoring device 1 100 (e.g., the first sensor 1310 or the second sensor 1320) to produce an emitted signal from the contact surface towards the target location. Such emitted signals can include, for example, an emitted current (e.g., for bioelectrical impedance measurement), a mechanical vibration signal (e.g., to characterize the viscoelastic tissue properties), a light signal (e.g., for optical measurements), an ultrasonic signal, or a thermal signal. The sensor module 1212 can cause the sensor(s) to vary the frequency, amplitude, or other aspects of the emitted signal in accordance with the methods described herein. In some embodiments, the sensor module can receive a received signal from the target location. In some embodiments, the sensor module 1212 is configured to contain calibration information associated with the sensors contained within the monitoring device and can process the received signals using the calibration information to produce one or more parameters (e.g., a sensor factor) associated with the sensor output. For example, in some embodiments where the sensor is a bioelectrical impedance sensor, the sensor module 1212 can receive a current signal and produce a sensor factor that is associated with the impedance of the patient and/or the target location.

[0062] The mapping module 1213 can be a hardware and/or software module (stored in memory 1211 and/or executed in the processor 1210). The mapping module 1213 is configured to generate a suitability map based on one or more sensor factors or suitability factors. The suitability map can identity⁷ various portions of the body and provide information related to their suitability for the medical use (including current suitability or possible remediation for future use).

[0063] The first sensor 1310 and any other sensors described herein (e.g., the optional second sensor 1320) can be any suitable sensor that can produce a signal associated with any of a structural tissue property associated with the target location, a mechanical tissue property associated with the target location, an optical tissue property associated with the target location, a physiological tissue property' associated with the target location, or thermal tissue property associated with the target location. For example, any of the sensors in the monitoring device 1100 (or any of the monitoring devices disclosed herein) can use one or more imaging technologies, including but not limited to optical technologies in visible, infrared or other wavelengths, pressure wave technologies, including but not limited to sound and vibration, such as ultrasound, and/or other forms of computed tomography. In addition or alternatively, any of the sensors in the monitoring device 1100 (or any of the monitoring devices disclosed herein) can include a mechanical sensing technology, such as a suction-based approach similar to that used in cutometers.

[0064] In some embodiments, the first sensor 1310 (or any other sensor of a monitoring device) is a bioelectrical impedance sensor that measures an impedance associated with the target location. The bioelectrical impedance sensor can include a set of electrodes including at least one emitter 1312 that produces an emitted current from the contact surface towards the target location. The set of electrodes can include at least one detector 1311 that receives a signal from the target location. As described herein, the controller 1200 and/or the sensor module 1212 can produce, based on the received signal, an impedance associated with the target location. As shown below (e.g., for the monitoring device 2100 and the monitoring device 3100), the electrodes can be coupled to the contact surface of the monitoring device, such that the electrodes contact a skin surface at the target location.

[0065] In some embodiments, as described herein, the monitoring device 1100 can include a mechanism to ensure that the electrodes are maintained in firm contact with the target location. For example, in some embodiments, the monitoring device can include one or more force sensors (e.g., strain gauge sensors; see FIG. 8) that can provide a measurement of the contact force between the contact surface 1120 and the target location. Similarly stated, in some embodiments, the second sensor 1320 can be a force sensor. Based on signals received from the force sensor, the monitoring device can produce an indication or error message to alert the user that the appropriate contact force is being applied or that additional force is necessary'. In this manner, the accuracy of the impedance measurement, which is used to assess the suitability of the target location, can be improved. In some embodiments, the controller 1200 and/or the sensor module 1212 can adjust the measured impedance based on the measured contact force (i.e., the monitoring device 1100 can apply contact resistance correction).

[0066] The electrodes can have any suitable size and/or shape. For example, in some embodiments, the electrodes have an area of between 50 and 1000 mm². Although show n in FIG. 2 as including only one emitter and one detector, in other embodiments, a bioelectrical impedance sensor includes a four-electrode configuration, which can improve measurement accuracy by reducing the impact of electrode-skin contact impedance. In some embodiments, the electrode spacing is variable to achieve different scanning depths. Shorter inter-electrode distances provide more superficial measurements, allowing localization of skin and subcutaneous tissue.

[0067] The controller 1200 and/or the sensor module 1212 can cause the emitter 1312 to produce an alternating current of any suitable magnitude (e.g., 1 mA or less) at a series of different current frequencies, which can be between 5kHz and 1MHz. For example, in some embodiments, the emitter can 1312 can produce a relatively low frequency current (approx. 5 kHz to 50 kHz) at a first time and a higher frequency current (approx. 100 kHz to 1 MHz) at a second time. The lower frequency current generally flows through the extracellular fluid, making the measured impedance an indicator of edema. The higher frequency current generally penetrates cell membranes. Thus, the impedance measurement is associated with an amount of total fluid near the target location, which can be an indicator of lipohypertrophy. Specifically, adipose (fat) tissue has high impedance, providing a distinct signature for identifying lipohypertrophic sites.

[0068] In some embodiments, the use of multiple different emitted frequencies can result in multiple, discrete measurements associated with the target location. Accordingly, in some embodiments, the controller 1200 and/or the sensor module 1212 can determine a sensor factor associated with the signals received from the first sensor 1310 (e.g., the bioelectrical impedance sensor). The sensor factor can be, for example, a weighted factor that corrects, adjusts, or otherwise provides a higher relevancy to one measurement over another measurement. For example, if the determination of suitability for a particular medical use relies more heavily on detecting the presence of lipohypertrophy than edema, then the sensor factor will reflect a higher weighting for signals associated with lipohypertrophy than those signals associated with edema. Moreover, because the amount of adipose tissue can also be related to the age or gender of the patient, the sensor factor can also account for the characteristics of the patient.

[0069] In some embodiments, the first sensor 1310 (or any other sensor of a monitoring device) is elastography sensor that measures a mechanical tissue property, such as a viscoelastic characteristic associated with the target location. The elastography sensor can perform point elastography. The elastography sensor can include one or more actuators (i.e., at least one emitter 1312) that produces an emitted mechanical signal from the contact surface towards the target location. The elastography sensor can include at least one detector 1311 that receives a signal from the target location. The actuators and/or detectors can be. for example, piezoelectric actuators. As described herein, the controller 1200 and/or the sensor module 1212 can produce, based on the received signal, an indication of the tissue’s viscoelastic properties, allowing the controller 1200 to distinguish between the signatures of dense fatty tissue (lipohypertrophy) and inelastic fibrous scar tissue associated with the target location. Certain properties that can be detected include the elastic modulus at a specific strain rate, shear modulus, bulk modulus, storage modulus, aggregate modulus (at equilibrium using fit), creep and relaxation constants, water content, and/or tissue permeability'.

[0070] As described above, in some embodiments, the monitoring device can include one or more force sensors that can provide a measurement of the contact force between the contact surface 1120 and the target location. Signals from the force sensor can improve the accuracy of the measurement of shear modus / viscoelasticity, which is used to assess the suitability of the target location. In some embodiments, the controller 1200 and/or the sensor module 1212 can adjust the measured viscoelasticity properties based on the measured contact force (i.e., the monitoring device 1100 can apply contact resistance correction).

[0071] The controller 1200 and/or the sensor module 1212 can cause the emitter 1312 to produce mechanical vibrations at a series of different force frequencies, which can be between 1Hz and 100kHz. For example, in some embodiments, the emitter can 1312 can produce a relatively low frequency vibration (approx. 1 Hz to 50 Hz) at a first time and a static indention at a second time. The dynamic stimulation is suitable for characterizing the tissue’s viscoelastic properties, allowing the monitoring device to distinguish between the signatures of dense fatty tissue (lipohypertrophy) and inelastic fibrous scar tissue. A static indentation provides a quantitative value for bulk stiffness or hardness, which can be an objective proxy for manual palpation to detect hard sites of fibrosis or advanced lipohypertrophy.

[0072] In some embodiments, the controller 1200 and/or the sensor module 1212 can determine a sensor factor associated with the signals received from the elastography sensor. The sensor factor can be, for example, a weighted factor that corrects, adjusts, or otherwise provides a higher relevancy to one measurement over another measurement. For example, if the determination of suitability for a particular medical use relies more heavily on detecting the presence of scar tissue than lipohypertrophy, then the sensor factor will reflect a higher weighting for signals associated with scar tissue than those signals associated with lipohypertrophy.

[0073] In some embodiments, the first sensor 1310 (or any other sensor of a monitoring device) is an optical sensor that measures optical tissue property associated with the target location. The optical sensor can include a set of optical elements (e.g., photodiodes, laser diodes, fiber optic components, photosensors, imaging devices, or the like) including at least one emitter 1312 that produces an emitted light signal from the contact surface towards the target location. The set of optical elements can include at least one detector 1311 that receives a light signal from the target location. As described herein, the controller 1200 and/or the sensor module 1212 can produce, based on the received signal, an indication of the tissue's optical properties. Such optical properties can include an absorption of the emitted light signal and/or a scattering of the emitted light signal, which can be indicative of the vascularization of the tissue, tissue perfusion, tissue oxygenation, and/or inflammation. The optical elements can be coupled to the contact surface of the monitoring device, such that they are in close proximity to a skin surface at the target location. In some embodiments, a distal end portion of the monitoring device includes a lens that forms a part of or includes the contact surface 1120.

[0074] In some embodiments, as described herein, the monitoring device 1100 can include a mechanism to ensure that the optical elements are maintained in firm contact with or in close proximity to the target location. For example, in some embodiments, the monitoring device can include one or more force sensors that can provide a measurement of the contact force between the contact surface 1120 and the target location. Based on signals received from the force sensor, the monitoring device can produce an indication or error message to alert the user that the appropriate contact force is being applied or that additional force is necessary. In this manner, the accuracy of the optical measurements, which are used to assess the suitability of the target location, can be improved.

[0075] The controller 1200 and/or the sensor module 1212 can cause the emitter 1312 to produce emitted light signals of any suitable magnitude and at a series of different light wavelengths, which can be between 495 nm and 2000 nm. For example, in some embodiments, the emitter 1312 can produce emitted light within the green light spectrum (e.g., 495nm- 570nm). Light in this range is strongly absorbed by hemoglobin in superficial dermal capillaries. Accordingly, measuring optical properties with emitted (or incident) light in this range is a direct and robust indicator of inflammation or allergic reaction, which are characterized by hyperemia (increased blood flow). In some embodiments, the emitter 1312 can produce emitted light within the red light spectrum (e.g., 620nm-750nm). Red light penetrates more deeply than other wavelengths and allows the assessment of tissue perfusion and oxygenation in the dermis and upper subcutaneous layers. Poorly perfused or hypoxic tissue signifies compromised metabolic health. In some embodiments, the emitter 1312 can produce emitted light within the infrared light spectrum (e.g., 750nm-1400nm). Infrared light achieves the deepest penetration within the wavelength ranges, allowing a robust assessment of the target subcutaneous layer. Its differential absorption by water and lipids allows for the quantitative detection of edema (excess water content) and lipodystrophy (abnormal fat concentration).

[0076] In some embodiments, the optical sensor can facilitate physiological sensing via photoplethysmography (PPG). Specifically, the optical sensor can be configured as a PPG sensor, using red (e.g., 660nm) and infrared (e.g., 940nm) wavelengths. This arrangement can allow the monitoring device to assesses dynamic circulatory health by measuring changes in light absorption from pulsatile blood flow. This allows for the quantitative determination of local tissue perfusion and oxygen saturation (SpO2), which are essential for drug absorption and tissue suitability.

[0077] In some embodiments, the optical sensor can facilitate physiological sensing via diffuse reflectance spectroscopy, where the monitoring device measures backscattered light intensity to infer absorption and scattering properties of the skin and subcutaneous tissues. Specifically, optical properties can include the absorption coefficient and scattering coefficient, chromophore concentration maps (for example hemoglobin), subsurface tissue structure based on spectral and spatial reflectance patterns.

[0078] In some embodiments, the emitter 1312 can produce an emitted light signal having a first wavelength at a first time and an emitted light signal having a second wavelength at a second time. The use of multiple different emitted wavelengths can result in multiple, discrete measurements associated with the target location. Accordingly, in some embodiments, the controller 1200 and/or the sensor module 1212 can determine a sensor factor associated with the signals received from the first sensor 1310 (e.g., the optical detector). The sensor factor can be, for example, a weighted factor that corrects, adjusts, or otherwise provides a higher relevancy to one measurement over another measurement. [0079] Although described as employing single-point detection with a single emitter, in other embodiments, the optical sensor and/or the monitoring device can include an array of photodiodes in rectangular or radial placement or 2D imaging modalities (for example CMOS hyperspectral camera) to spatially resolve tissue properties.

[0080] In some embodiments, the second sensor 1320 (or any other sensor of a monitoring device) is a temperature sensor that measures a thermal tissue property associated with the target location. The temperature sensor can include a thermal excitation source (e.g., a contact heating element or pulsed LED) and a temperature sensor. As described herein, the controller 1200 and/or the sensor module 1212 can produce, based on the received temperature signal, an indication of the tissue’s thermal properties. Such thermal tissue properties include any of a temperature of the target location, a thermal conductivity associated with the target location, or a thermal capacity⁷ associated with the target location. For example, an elevated baseline temperature is a primary indicator of inflammation. As another example, the transient response of the tissue to a thermal pulse can be measured. Adipose tissue, a natural insulator, dissipates heat slowly, providing a specific method for identifying lipohypertrophy. Well-perfused or edematous tissue dissipates heat quickly. Additionally, variations in thermal properties can be correlated with underlying skin thickness, fat content, vascularization, or hydration. For instance higher thermal conductivity’ may indicate lower fat content or higher water content. Also, longer thermal relaxation time may correlate with increased subcutaneous fat thickness.

[0081] In some embodiments, the baseline temperature can also be used to monitor the efficacy of the contact between the contact surface 1120 and the target location. If. for example, the baseline temperature is low or changing above a predetermined threshold, the controller 1200 and/or the monitoring device an identify that intermittent or poor contact is likely resulting. In response, the controller 1200 can produce an error signal prompting the user to maintain consistent and/or even contact pressure.

[0082] The first sensor 1310 and/or the second sensor 1320 (and any other sensors herein) can include other suitable sensors. In some embodiments, a sensor can be a single-axis ultrasound transducer, which can provide a direct, quantitative measure of subcutaneous fat layer thickness by measuring the time-of-flight of sound waves, allowing for the definitive identification of lipoatrophy. In other embodiments, a sensor can be contact sensor to measure skin surface pH, which can be used by the controller 1200 to assess the integrity' of the skin's acid mantle. This is often compromised by chronic irritation, providing a valuable metabolic data point for use according to the methods herein. In yet other embodiments, a sensor can include a thermistor, accelerometer, gyroscope, etc., which can be operable to provide additional inputs in the microcontroller logic to support site assessments or pass that additional data directly to the mobile application.

[0083] In some embodiments, any of the monitoring devices herein can include two, three or more sensors to produce a multi-modal analysis of suitability of the target location for the intended use.

[0084] In some embodiments, the monitoring device 1100 include a marking element 1160 supported by the housing 1110. The marking element 1160 can be any suitable marker that can place a mark or indicator (e.g., ink, dye, or the like) at the target location. The marking can be placed with biocompatible ink pads or jets, laser marking, or compliant actuators that would leave a temporary depression in the skin. Thus, in addition to producing electronic indicators, the monitoring device can also provide a means to physically mark the target location so the user understands the exact location of suitable sites to provide a target for injection or infusion site placement, as well as unsuitable sites for potential treatment solutions.

[0085] FIG. 4 is a flow chart of a method 10 of assessing a suitability of a target location for a medical use via a handheld monitoring device. The handheld monitoring device includes a housing, a sensor, and a controller. The medical use includes any of subcutaneous drug delivery' or continuous analyte measurement. The method 10 can be performed via any suitable medical system and/or monitoring device, as described herein. The method 10 includes receiving, via a communication module implemented in at least one of a memory or a processing device of the controller, an input associated with the medical use, at 11. The method includes receiving, via a sensor module implemented in at least one of the memory' or the processing device of the controller, a signal from the sensor, the signal associated with the target location, at 12. A suitability factor is determined based on the input and the signal, at 13. The method further includes producing, via an output module implemented in at least one of the memory' or the processing device of the controller, an indication on a condition that the suitability' factor is within a suitability' threshold associated with the suitability of the target location for the medical use, at 14.

[0086] FIGS. 5-7 are a side view (FIG. 5), a top view (FIG. 6) and a bottom view (FIG. 7) of a handheld monitoring device 2100, according to an embodiment. The monitoring device 2100 can be used within or form a part of any system, such as the system 1000 described herein. Moreover, the monitoring device 2100 can include any of the features shown and described for the monitoring device 1100, such as, for example, the controller 1200. The monitoring device 2100 includes a housing 2110, a first sensor (not shown, but w hich can be similar to the sensors described herein), a controller (not shown, but which can be similar to the controller 1200), and an output assembly 2230. The monitoring device 2100 can optionally include an on-board power supply within the housing 2110, additional sensors, and a marking element (not shown).

[0087] The housing 2110 can be any structure that contains and/ or supports the components of the monitoring device (e.g., the controller and the sensors). In some embodiments, the monitoring device 2100 has a size, shape and/or weight such that the device can be held, used and/or manipulated in a user’s hands (i.e., it can be a “handheld” device). In other embodiments, the monitoring device 2100 can be a self-contained device that has an overall volume of less than about 330 cm³ (or about 20 cubic inches). The housing 2110 includes a user interface portion 2112, a grip portion 2111, and a contact surface 2120. The user interface portion 2112 can be accessible and/or viewable by a user and can provide the structure for mounting various user input / output features, such as a power switch 2151 , an activation button (not show), and an output assembly 2230 (e g., a light). The user interface portion can be located on a top portion of the housing 2110 (i.e.. opposite the contact surface 2120) to allow for easy viewing and use by the user. In some embodiments, the output assembly 2230 can be a touch screen for displaying the indications described herein and/or for receiving input.

[0088] The contact surface 2120 can include a flat portion that is placed in contact with the skin of the target location. In some embodiments, the contact surface can include a concave portion configured to cup or receive a portion of the target location. As shown, the contact surface can include an opening or window 2123 through which a marking element (not shown) can extend to mark the skin, as described herein.

[0089] FIG. 8 is a bottom view of a handheld monitoring device 3100, according to an embodiment. The monitoring device 3100 can be used within or form a part of any system, such as the system 1000 described herein. Moreover, the monitoring device 3100 can include any of the features shown and described for the monitoring device 1100 or the monitoring device 2100, such as, for example, the controller 1200. The monitoring device 3100 includes a housing 3110, a first sensor assembly 3310, a set of force sensors 3350, a controller (not shown, but which can be similar to the controller 1200), and an output assembly (not shown). [0090] The contact surface 3120 can include a flat portion that is placed in contact with the skin of the target location. In other embodiments, the contact surface can include a concave portion configured to cup or receive a portion of the target location. As shown, the contact surface can include an opening or window 3123 through which a marking element (not shown) can extend to mark the skin, as described herein.

[0091] The first sensor assembly 3310 includes four emitters and/or receivers (only one is marked) spaced apart on the contact surface 3120. The first sensor assembly⁷ 3310 can be, for example, a bioelectric impedance sensor that includes four electrodes. In other embodiments, the first sensor assembly 3310 can be an optical sensor that includes four photodiodes and/or detectors. Including multiple light sources can allow for multi-point analysis while the contact surface 3320 is in a fixed location relative to the target location (e g., pressed and held stationary' against the skin).

[0092] In use, a user would select a target site for evaluation. In some embodiments, the user can input information (e.g., input associated with the desired medical action, input associated with the patient, or any other input as described herein). The user can turn the power on and place the contact surface (e.g., 1120, 2120, or 3120) of the device (e.g., monitoring device 1100, 2100. or 3100) on the skin, depressing slightly to ensure that a sufficient contact force is generated. As described herein, in some embodiments, the monitoring device can produce an indication confirming proper placement of the contact surface against the skin. The force can be measured using one or more force sensors (e.g., force sensors 3350). For example, in some embodiments, the force sensor(s) can be strain gauge sensors that are coupled to a flexible portion or "tab” of the contact surface. The strain gauges can measure the deflection of the flexible tabs and, based on the deflection produce an indication confirming that a sufficient force is applied. In some embodiments, the monitoring device can produce an error code on a condition that the force signal is outside of a contact force threshold. In this manner, the monitoring device (and methods described herein) can limit the likelihood of erroneous measurements or false indications of site suitability that may result from insufficient contact with the skin.

[0093] The monitoring device can then be actuated to perform any of the measurements and analysis described herein. The signals from one or more of the sensors referenced is processed by' firmware and/or software executed by the controller (e.g., the controller 1200) to provide direct values or a composite risk or suitability indicator of the target location. In some embodiments, the controller and/or the sensor module can interpret the response of light or pressure waves through the sensors to indicate if the target location on the skin is suitable for the medical use, questionable, or unacceptable. Based on this analysis the monitoring would respectively display a positive, cautionary or negative indicator. In the case of a positive indicator the device could automatically or optionally, through another user action, place a mark indicating a target for insertion. Similarly, a negative, or a cautionary indicator could automatically place a mark to indicate a location for potential topical or other therapeutic treatments. The marks can be different in size, shape, color or other means to allow the user to easily differentiate the markings.

[0094] In some embodiments, the monitoring device can instruct the user to gently move the contact surface relative to the skin (e g., rotating the contact surface or sliding the contact surface linearly). In this manner, the sensors can provide multiple point analysis. For example, in this manner, an optical sensor can “scan” multiple locations with a limited spatial region. This can provide additional input to better identify vasculature or other structure of the tissue that can impact the suitability of the target location for the medical use.

[0095] In other embodiments, any of the monitoring devices described herein can include one or more sensors that are movable relative to the housing. For example, in some embodiments, a monitoring device can have a rotatable or sliding carriage that can allow multipoint analysis while the monitoring device is maintained in a constant position against the skins. Specifically, the carriage can include optical sensors, piezoelectric actuators, and/or a marking element, and can be configured to steadily move during a site interrogation operation.

[0096] In some embodiments, the monitoring devices and systems described herein (e.g., the system 1000) can be used to track the suitability of a target location over a time period between (or including) multiple medical actions or uses. Similarly stated, in some embodiments, the system 1000 can receive information associated with the suitability of a target location from each use of the monitoring device (e g., the monitoring device 1100, 2100 or 3100) and aggregate the information to provide a temporal (or historical) assessment of the suitability of the target location. For example, in some embodiments, the indications, suitability factors, sensor factors, or other information determined by the controller 1200 during each use of the monitoring device can be transmitted to the external computing device 1250. The medical application 1260 can receive this suitability data and can track, process, and/or manipulate the suitability data to provide a temporal assessment of the target location. For example, if the target locations include a left side portion of the abdomen and the left thigh, the medical application and produce indications, graphs, or other outputs that convey to the user how the left side of the abdomen and the left thigh are performing as target sites for the intended medical use. For example, if the left side of the abdomen maintains a poor suitability factor (or assessment) over a predetermined time period, then the medical application 1260 and produce an indication to notify the user (or a healthcare provider) that additional remedial action may be necessary.

[0097] In some embodiments, such temporal data can be conveyed from the external computing device 1250 to the monitoring device 1100 as input. For example, if the user selects the left side of the abdomen as being the desired target location and the temporal data suggests that the suitability of this portion of the body has been slow to recover (i.e., to achieve a desired suitability factor), then the monitoring device can provide an indication to notify the user to select a different portion of the body (e.g.., the left thigh) as the target location for the current medical use. In other embodiment, the suitability factor for a given target location can be determined based not only on the user input (as described herein) and the sensor data, but also based on historical data associated with the target location.

[0098] While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods and/or schematics described above indicate certain events and/or flow patterns occurring in certain order, the ordering of certain events and/or operations may be modified. While the embodiments have been particularly shown and described, it will be understood that various changes in form and details may be made.

[0099] Although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having a combination of any features and/or components from any of embodiments as discussed above. Aspects have been described in the general context of medical uses (or actions) such as drug delivery and analyte measurement. However, any of the systems, devices, and methods described herein can be used for any other medical, therapeutic, or cosmetic procedures or treatments. For example, any of the systems, devices, and methods described herein can be used to assess the suitability of a target location for a surgical incision (e.g., a laparoscopic entry point), a point of application for topical therapy (e.g., for massage or physical therapy), or for delivery of fillers or other cosmetic components. Moreover, the inventive aspects described herein are not necessarily limited to use in medical, therapeutic, or cosmetic applications.

Claims

What is claimed is:

1 . An apparatus, comprising: a housing having a contact surface configured to contact a target location; a sensor at least partially within the housing, the sensor include an emitter and a detector; and a controller including a processor and a memory, the controller being operably coupled to the sensor and an input device, the controller being configured to execute a plurality of operations to assess a suitability of the target location for a medical use including any of subcutaneous drug delivery or continuous analyte measurement, the plurality of operations including: receiving an input associated with the medical use; causing the emitter to produce an emitted signal from the contact surface towards the target location; receiving from the detector a received signal from the target location; and producing, based on the input and the received signal, an indication associated with the suitability of the target location for the medical use.

2. The apparatus of claim 1. wherein the input includes a body portion associated with the target location.

3. The apparatus of claim 2, wherein the input includes a characteristic of a patient associated with the target location.

4. The apparatus of claim 3, wherein the input includes any of a drug for subcutaneous drug delivery, a dosage of the drug, a delivery mechanism, or a characteristic of a needle through which the drug is delivered.

5. The apparatus of claim 1, wherein the received signal is associated with any of a structural tissue property associated with the target location, a mechanical tissue property associated with the target location, an optical tissue property' associated with the target location, a physiological tissue property associated with the target location, or thermal tissue property associated with the target location.

6. The apparatus of claim 5, wherein: the sensor is a bioelectrical impedance sensor; and the structural tissue property is associated with an impedance associated with the target location.

7. The apparatus of claim 6, wherein: the emitter of the bioelectrical impedance sensor is a first electrode and the receiver of the bioelectrical impedance sensor is a second electrode, each of the first electrode and the second electrode coupled to the contact surface; and the causing the emitter to produce the emitted signal includes emitting an alternating current at a plurality of different current frequencies between 5kHz and 1MHz.

8. The apparatus of claim 7, wherein: the plurality' of frequencies includes a first current frequency of between 5kHz and 50 kHz and a second current frequency of between 100 kHz and 1 MHz.

9. The apparatus of claim 5, wherein: the sensor is an elastography sensor; and the mechanical tissue property is associated with a viscoelastic characteristic associated with the target location.

10. The apparatus of claim 9, wherein: the emitter of the elastography sensor includes a piezoelectric actuator coupled to the contact surface; and the causing the emitter to produce the emitted signal includes emitting a mechanical force at a force frequency of between 1 Hz and 100 kHz.

11. The apparatus of claim 10, wherein the causing the emitter to produce the emitted signal includes: producing a static indentation at the target location; and emitting a mechanical force at a force frequency between 1 Hz and 50 Hz.

12. The apparatus of claim 5, wherein: the sensor is an optical sensor; the emitter of the optical sensor includes a light source, the emitted signal is an emitted light signal, and the detector of the optical sensor is a photodetector; and the optical tissue property is associated with any of an absorption of the emitted light signal or a scattering of the emitted light signal.

13. The apparatus of claim 12, wherein: the causing the emitter to produce the emitted light signal includes emitting the emitted light signal having a wavelength of between 495 nm and 1400 nm.

14. The apparatus of claim 13, wherein: the causing the emitter to produce the emitted light signal includes emitting the emitted light signal at a plurality of different wavelengths including a first wavelength of between 495 nm and 570 nm and a second wavelength of between 750 nm and 1400 nm.

15. The apparatus of claim 5, wherein: the sensor is a temperature sensor; and the thermal tissue property is associated with any of a temperature of the target location, a thermal conductivity associated with the target location, or a thermal capacity associated with the target location.

16. The apparatus of claim 5, wherein: the sensor is a first sensor of a plurality of sensors at least partially within the housing, the first sensor being any of a bioelectrical impedance sensor, an elastography sensor, an optical sensor, or a temperature sensor; the plurality of sensors including a second sensor, the second sensor being any other of the bioelectrical impedance sensor, the elastography sensor, the optical sensor, or the temperature sensor; and the producing the indication associated with the suitability of the target location for the medical use includes: determining a first sensor factor associated with the received signal from the first sensor and a second sensor factor associated with the received signal from the second sensor; determining a suitability factor based on the input, the first sensor factor, and the second sensor factor; and producing the indication on a condition that the suitability factor is within a suitability’ threshold.

17. The apparatus of claim 16, wherein: the indication is a first indication; the suitability threshold is a first suitability threshold; and the plurality of operations further includes: producing a second indication on a condition that the suitability factor is within a second suitability' threshold.

18. The apparatus of claim 17. wherein the plurality of operations further includes: producing a third indication on a condition that the suitability factor is outside of at least one of the first suitability threshold or the second suitability threshold.

19. The apparatus of claim 16, further comprising: a force sensor operably coupled to the contact surface, the force sensor configured to produce a force signal associated with a contact force exerted on the contact surface; and the plurality of operations further includes: producing an error code on a condition that the force signal is outside of a contact force threshold.

20. The apparatus of claim 16, further comprising: a temperature sensor operably coupled to the contact surface, the temperature sensor configured to produce a temperature signal associated with the target location; and the plurality of operations further includes: producing an error code on a condition that the temperature signal is outside of a contact temperature threshold.

21. The apparatus of claim 16. further compnsing: a marking element within the housing, wherein the plurality of operations further includes: marking the target locations on a condition that the suitability' factor is within the suitability threshold.

22. An apparatus, comprising: a housing having a contact surface configured to contact a target location; a first sensor at least partially within the housing, the first sensor being any of a bioelectrical impedance sensor, an elastography sensor, an optical sensor, or a temperature sensor; a second sensor at least partially within the housing, the second sensor being different from the first sensor and being another of the bioelectrical impedance sensor, the elastography sensor, the optical sensor, or the temperature sensor: and a controller including a processor and a memory⁷, the controller being operably coupled to the first sensor and the second sensor, the controller being configured to execute a plurality of operations to assess a suitability of the target location for a medical use including any of subcutaneous drug delivery or continuous analyte measurement, the plurality of operations including: receiving an input associated with the medical use; receiving a first signal from the first sensor; receiving a second signal from the second sensor; determining a first sensor factor associated with the first signal and a second sensor factor associated with the second signal; determining a suitability factor based on the input, the first sensor factor, and the second sensor factor; and producing an indication on a condition that the suitability factor is within a suitability threshold associated w ith the suitability of the target location for the medical use.

23. The apparatus of claim 22, wherein the input includes any of an identification of a body portion associated w ith the target location or a characteristic of a patient associated with the target location.

24. The apparatus of claim 22. wherein the input includes any of a drug for subcutaneous drug delivery, a dosage of the drug, a delivery mechanism, or a characteristic of a needle through which the drug is delivered.

25. The apparatus of claim 22. further comprising: a force sensor operably coupled to the contact surface, the force sensor configured to produce a force signal associated with a contact force exerted on the contact surface; and the plurality of operations further includes: producing an error code on a condition that the force signal is outside of a contact force threshold.

26. A method of assessing a suitability of a target location for a medical use via a handheld monitoring device, the handheld monitoring device including a housing, a sensor, and a controller, the medical use including any of subcutaneous drug deliver}' or continuous analyte measurement, the method comprising: receiving, via a communication module implemented in at least one of a memory or a processing device of the controller, an input associated with the medical use; receiving, via a sensor module implemented in at least one of the memory or the processing device of the controller, a signal from the sensor, the signal associated with the target location; determining a suitability factor based on the input and the signal; and producing, via an output module implemented in at least one of the memory or the processing device of the controller, an indication on a condition that the suitability' factor is within a suitability threshold associated with the suitability of the target location for the medical use.

27. The method of claim 26, wherein the input includes any of an identification of a body portion associated with the target location or a characteristic of a patient associated with the target location.

28. The method of claim 26, wherein the input includes a prior suitability assessment associated with the target location.

29. The method of claim 26, wherein the input includes any of a drug for subcutaneous drug delivery, a dosage of the drug, a delivery mechanism, or a characteristic of a needle through which the drug is delivered.

30. The method of claim 26, wherein the target location is a first target location of a plurality of target locations, the suitability factor is a first suitability factor of a plurality’ of suitability factors, the method further comprising: receiving, via the sensor module, a signal from the sensor associated with each target location of the plurality' of target locations; determining a suitability factor associated with each target location of the plurality’ of target locations based on the input and the signal associated with each target location of the plurality of target locations; and producing, via an output module implemented in at least one of the memory’ or the processing device of the controller, a suitability' map based on the plurality of suitability factors.

31. The method of claim 26, further comprising: operably coupling the controller to an external computing device, the input associated with the medical use being received from the external computing device; and transmitting the indication to the external computing device.

32. The method of claim 26, further comprising: producing, via an output module implemented in at least one of the memory or the processing device of the controller, a marking signal to cause a marking element of the handheld monitoring device to mark the target location.

33. The method of claim 26, wherein: the sensor is a first sensor, the first sensor being any of a bioelectrical impedance sensor, an elastography sensor, an optical sensor, or a temperature sensor, the handheld monitoring device includes a second sensor, the second sensor being any other of the bioelectrical impedance sensor, the elastography sensor, the optical sensor, or the temperature sensor, and the signal is a first signal, the method further comprising: receiving, via the sensor module implemented in at least one of the memory’ or the processing device of the controller, a second signal from the second sensor, the second signal associated with the target location; and the determining the suitability factor is based on the input, the first signal, and the second signal.

34. A non-transitory computer-readable medium configured to store a program which, when executed by a processor causes a device to perform the method of claim 26.

35. A non-transitory processor-readable medium storing code representing instructions to be executed by a processor of a handheld monitoring device, the handheld monitoring device including a housing, a first sensor, and a second sensor, the code comprising code to cause the processor to: receive an input associated with a medical use; receive a first signal from the first sensor, the first signal associated with a target location of a body; receive a second signal from the second sensor, the second signal associated with the target location of the body; determine a suitability factor of the target location based on the input, the first sensor factor, and the second sensor factor; and produce an indication on a condition that the suitability factor is within a suitability threshold associated with the suitability of the target location for the medical use.

36. A method of assessing a suitability of a target location for a medical use via a handheld monitoring device, the handheld monitoring device including a housing, a sensor, and a controller, the method comprising: inputting an input parameter associated with a medical use; placing a contact surface of the handheld monitoring device against a target location of a body; and actuating the handheld monitoring device to cause the device to: produce an emitted signal from the contact surface towards the target location; receive, via the sensor, a received signal from the target location; and produce, based on the input and the received signal, an indication associated with the suitability of the target location for the medical use.