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WO2024243228A1 - Ear cleaning devices - Google Patents

Ear cleaning devices Download PDF

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Publication number
WO2024243228A1
WO2024243228A1 PCT/US2024/030405 US2024030405W WO2024243228A1 WO 2024243228 A1 WO2024243228 A1 WO 2024243228A1 US 2024030405 W US2024030405 W US 2024030405W WO 2024243228 A1 WO2024243228 A1 WO 2024243228A1
Authority
WO
WIPO (PCT)
Prior art keywords
ear
fluid
reservoir
delivery element
channel
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
Application number
PCT/US2024/030405
Other languages
French (fr)
Inventor
Aadil DIWAN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Safkan Inc
Original Assignee
Safkan Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Safkan Inc filed Critical Safkan Inc
Publication of WO2024243228A1 publication Critical patent/WO2024243228A1/en
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F11/00Methods or devices for treatment of the ears or hearing sense; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0233Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
    • A61M3/0245Containers therefor, e.g. with heating means or with storage means for cannula
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0233Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
    • A61M3/0254Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped
    • A61M3/0258Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped by means of electric pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/027Devices for holding the cannula in position, e.g. belts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0279Cannula; Nozzles; Tips; their connection means
    • A61M3/0287Cannula; Nozzles; Tips; their connection means with an external liquid collector
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71Suction drainage systems
    • A61M1/77Suction-irrigation systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2209/00Ancillary equipment
    • A61M2209/08Supports for equipment
    • A61M2209/088Supports for equipment on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/06Head
    • A61M2210/0662Ears

Definitions

  • the present disclosure relates generally to an ear cleaning device, and specifically to systems, devices, and methods for irrigating an ear canal of a subject.
  • Ear wax also known as cerumen, naturally forms in the outer portion of a person’s ear and serves to protect and lubricate the ear canal or auditory canal.
  • the motion of a person’s jaw assists in moving old ear wax towards the outside of the auditory canal where it dries up and falls away.
  • ear wax may build up in the auditory canal to the point that it impacts a person’s hearing.
  • built-up ear wax may accumulate at any point in or about the auditory canal, and at any point on or along a surface of the auditory canal.
  • Some people may attempt to clean their ears with physical objects, such as cotton swabs, that can generally push ear wax deeper into the auditory canal towards the ear drum.
  • Systems, devices, and methods described herein provide for cleaning of an ear, e.g., to remove ear wax and other debris from within an ear canal.
  • an apparatus can include a support structure including a coupling element detachably couplable to a delivery element and defining a cavity configured to receive an ear of a subject; a first reservoir couplable to the support structure and configured to contain a first volume of fluid; a first channel configured to provide fluid communication between the first reservoir and the coupling element such that the first volume of fluid can be delivered from the first reservoir to the coupling element; a second reservoir couplable to the support structure and configured to receive a second volume of fluid; a second channel configured to provide fluid communication between the second reservoir and the coupling element such that the second volume of fluid can be received in the second reservoir from the coupling element; and a delivery element coupled to the coupling element, the delivery element having a body that curves from a proximal end to a distal end of the delivery element.
  • an apparatus can include a curved body configured to be inserted into an ear canal, the curved body having a proximal end that is angled relative to a distal end by an angle of between about 10 degrees and about 50 degrees, the curved body having a first portion that defines an inlet channel and a second portion that defines an outlet channel, the inlet and the outlet channels being curved from the proximal end to the distal end of the curved body; and a nozzle disposed at a distal end of the curved body, the nozzle including at least three openings configured to dispense fluid streams at different angles.
  • an apparatus can include a support structure; an ear pad coupled to the support structure, the ear pad defining a cavity for receiving an ear of a subject when the ear pad is placed against a head of the subject, the ear pad including: a windowed portion configured to provide a line of sight into the cavity to confirm a placement of the ear within the cavity; and a drip catch configured to capture a portion of fluid used during an ear cleaning procedure that leaks from an ear canal of the subject; a first reservoir removably coupled to the support structure, the first reservoir configured to hold a first volume of the fluid prior to the ear cleaning procedure; and a second reservoir removably coupled to the support structure, the second reservoir configured to receive a second volume of the fluid used during the ear cleaning procedure via a channel defined in the support structure.
  • an apparatus can include a support structure; a first reservoir removably coupled to the support structure, the first reservoir configured to hold a first volume of fluid for a cleaning procedure; a second reservoir removably coupled to the support structure, the second reservoir configured to receiving a second volume of fluid used during the cleaning procedure; a delivery element removably coupled to the support structure, the delivery element positionable within an ear canal of an ear during the cleaning procedure, the delivery element including: a first channel configured to deliver the first volume of fluid from the first reservoir to the ear canal; a nozzle in fluid communication with the first channel, the nozzle having at least three openings, each opening of the at least three openings being directed at a different angle relative to the other openings; a second channel configured to receive the second volume of fluid from the ear canal and to direct the second volume of fluid toward the second reservoir; and an opening in fluid communication with the second channel and configured to receive the second volume of fluid from the ear canal.
  • a method can include pumping fluid from a first reservoir through a first channel of an earpiece to a delivery element disposed within an ear canal of a subject; delivering the fluid into the ear canal through at least three openings of the delivery element, each opening of the at least three openings being directed at a different angle relative to the other openings; and generating negative pressure in a second reservoir to draw at least a portion of the fluid from the ear canal through the delivery element and a second channel of the earpiece into the second reservoir.
  • FIG. l is a schematic diagram depicting an ear cleaning or irrigation device, according to an embodiment.
  • FIG. 2 is a schematic diagram depicting an ear cleaning or irrigation device, according to an embodiment.
  • FIG. 3 is a front view of an ear cleaning or irrigation device on a stand, according to an embodiment.
  • FIG. 4 is a perspective view of on earpiece of the ear cleaning or irrigation device, according to an embodiment.
  • FIG. 5A is a front view of an earpiece of an ear cleaning device engaging a head of a patient, according to an embodiment.
  • FIGS. 5B-5C depict views of ear cleaning device of FIG. 5 A.
  • FIGS. 6A-6B depict an ear pad, according to an embodiment.
  • FIGS. 7A-7D depict a long ear tip, according to an embodiment.
  • FIGS. 8A-8D depict a short ear tip, according to an embodiment.
  • FIGS. 9A-9D depict various ear tips engaging an ear canal, according to embodiments.
  • FIGS. 10A-10D depict various nozzles of an ear tip, according to embodiments.
  • FIGS. 11 A-l 1C depict a discharge reservoir, according to an embodiment.
  • Ear wax also known as cerumen, naturally forms in the outer portion of a person’s auditory canal and serves to protect and lubricate the auditory canal.
  • ear wax may build up in the auditory canal to the point that the ear wax can impact a person’s hearing.
  • objects inserted into the auditory canal e.g., cotton swabs, fingers
  • ear cleaning techniques in which a mixture of saline, hydrogen peroxide, and/or water is used to irrigate the auditory canal and remove an excessive build-up of ear wax.
  • irrigating the auditory canal by way of such techniques may, however, require a visit to a physician and the use of devices that require multiple people to operate.
  • such devices and techniques that are used to irrigate the auditory canal may result in used cleaning agent or cleaning fluid, usually carrying flushed ear wax, to exit the auditory canal and impact the patient.
  • a physician or other individual needs to clean a surrounding area and/or components used to collect used cleaning agent or flushed ear wax. Accordingly, it can be desirable to have a system for cleaning an auditory canal that overcomes the aforementioned problems, which can be operable by a single user, to safely and effectively clean the auditory canal, e.g., by irrigation and removal of excessive ear wax.
  • Embodiments of the present disclosure are directed to an ear irrigation and cleaning device and system.
  • the ear cleaning device and system can be operable by a single user to safely and effectively clean an auditory canal by irrigation and removal of excessive ear wax.
  • the ear of a user, patient, or subject includes an auricle and an auditory or ear canal (collectively, e.g., “outer ear”, “external ear”, etc.).
  • the auricle is a visible portion of the ear residing on an outside of the user’s head.
  • the ear canal includes a portion of the ear extending inwardly from the auricle towards an eardrum (“eardrum” or “tympanic membrane”) to connect the eardrum to the auricle.
  • Ear wax can build up or accumulate along a surface of the auricle and/or the ear canal.
  • FIG. 1 is a schematic diagram depicting an ear cleaning or irrigation device 100, according to an embodiment.
  • the ear cleaning device 100 may include, for example, a delivery element or cannula 110, an inlet port 112, a discharge port 114, a fluid reservoir 120 (“fluid reservoir 120” or “cleaning agent reservoir 120” or “fluid cleaning agent reservoir 120” or “first reservoir 120”), a discharge reservoir 130 (“discharge collection reservoir 130” or “second reservoir 130”), a support element 103, an inlet path 116, and a discharge path 118.
  • a delivery element or cannula 110 may include, for example, a delivery element or cannula 110, an inlet port 112, a discharge port 114, a fluid reservoir 120 (“fluid reservoir 120” or “cleaning agent reservoir 120” or “fluid cleaning agent reservoir 120” or “first reservoir 120”), a discharge reservoir 130 (“discharge collection reservoir 130” or “second reservoir 130”), a support element 103, an inlet path 116,
  • the ear cleaning device 100 may be worn on or by a user (e.g., on a head of the user), by positioning the support element 103 adjacent to an auricle of the user and mounting delivery element 110 in ear canal EC, to clean the ear canal EC by irrigation and removal of excessive ear wax.
  • the irrigation and removal of excessive ear wax may include, for example, delivering a fluid cleaning agent to ear canal EC from the fluid reservoir 120 via the inlet path 116 and the inlet port 112.
  • the fluid can be delivered at a preset pressure and/or preset flow rate sufficient to dislodge excessive ear wax from surfaces located in the ear canal EC.
  • the fluid can be pre-pressurized within the fluid reservoir 120 such that the fluid, when released from the fluid reservoir 120 (e.g., by a valve), is delivered under a preset pressure and/or preset flow rate.
  • the irrigation and removal of excessive ear wax may further include removing applied fluid from ear canal EC by discharge of the applied fluid through discharge port 114.
  • the discharged fluid may be received in discharge reservoir 130 for later disposal via discharge path 118.
  • the applied fluid may include a mixture of applied cleaning fluid and dislodged and entrained excessive ear wax from the ear canal EC.
  • ear cleaning device 100 may be anatomically sized to fit a user, such as with respect to an anatomical size of the auricle and/or ear canal EC, as shown in FIG. 1.
  • ear cleaning device 100 may include a delivery element (e.g. delivery element 110) having a longitudinally tapering or constant diameter, cross-section, or the like, to facilitate insertion and fit in ear canal EC.
  • delivery element 110 may include, for example, a longitudinally tapering diameter having variation within a range of approximately 4 to 7 millimeters (mm).
  • delivery element 110 may include a longitudinally tapering diameter having variation within a range suitable and compatible for use with an anatomical size of a user, patient, or subject.
  • delivery element 110 may include a longitudinally tapering shape that gradually decreases in diameter from a proximal end (e.g., as in the end adjacent to the support element 103) to a distal end (e.g., as in the end disposable in ear canal EC). Delivery element 110 may otherwise include a longitudinally constant diameter.
  • the delivery element may include curved portions configured to match the anatomical shape of the ear canal EC.
  • the delivery element 110 may include an inlet channel 112 and a discharge channel 114.
  • inlet channel 112 may be configured to deliver fluid to the ear canal EC from the fluid reservoir 120.
  • the distal end of the inlet channel 112 includes a nozzle configured to direct fluid, e.g., into the ear canal EC.
  • the nozzle includes one or more apertures configured to deliver the fluid at different angles and/or with a predefined spray pattern.
  • the nozzle includes two streams that direct flow upward and one that directs flow downward.
  • the apertures of the nozzle can be sized to deliver the fluid at predetermined fluid flow rates.
  • the discharge channel 114 includes an opening configured to receive and direct discharged fluid to the discharge reservoir 130.
  • the delivery element 110 may be disposable and/or recyclable.
  • the delivery element 110 may include or may be made partially or entirely of disposable and/or recyclable plastic materials.
  • the delivery element 110 can be sized for use by different patient populations, e.g., for use by an adult, a child, and/or other populations.
  • the delivery element 110 can have different configurations depending on the size of the ear canal EC.
  • the delivery element 110 can have different configurations for cleaning different portions of the ear canal EC.
  • the delivery element 110 can have a longer configuration configured to clean a deeper portion of the ear canal EC and shorter configuration configured to clean a shallower portion of the ear canal EC.
  • the delivery element 110 can have different size for accommodating different sized ears of a user, e.g., a first size for pediatric users vs. a second size for adult users.
  • the delivery element 110 can have curvatures and/or angles along its longitudinal length toward the mandible that more closely track or follow the general shape of an ear canal EC, e.g., for better positioning within an ear canal and/or comfort during use.
  • the delivery element 110 can have a distal portion that is angled relative to a proximal portion by between about 10 degrees to about 45 degrees, including all ranges and values therebetween.
  • ear cleaning device 100 may optionally include an ear pad 122.
  • the ear pad 122 may be positioned adjacent to a perimeter of delivery element 110 to support the ear cleaning device 100 on the head of the patient.
  • ear pad 122 may include an annular membrane concentrically arranged at or about the perimeter of delivery element 110.
  • the annular membrane may be sized and shaped to resemble a portion of a solid torus (e.g., the top half of a doughnut).
  • Such a curved or partially toroidal surface may be used to create a barrier about delivery element 110, so as to contain or catch communicated fluid to increase the user’s comfort when wearing the ear cleaning device 100.
  • the ear pad 122 includes a recessed portion.
  • the recessed portion when the ear cleaning device 100 is worn, can function as a window through which a user can confirm proper positioning of the delivery element 110 in the ear canal EC. This can be beneficial, for example, to a caregiver, healthcare professional, etc. who may be placing the device onto a patient.
  • the support element 103 (or other portion of the ear cleaning device) includes a light (e.g., LED light) that allows for better visualization of the delivery element 110 when the ear cleaning device 100 is being worn. For example, the light can light up a space near the delivery element 110 so that it is easier for a healthcare professional to see the delivery element 110 being placed into the ear canal EC.
  • the ear cleaning device can include one or more sensors (e.g., pressure sensors) that can provide feedback for activating one or more lights to indicate when the delivery element 110 has been placed within the ear canal.
  • the sensors can detect, for example, pressure against the delivery element 110 and/or air pressure changes in the ear canal as the delivery element 110 is being placed within the ear canal.
  • the ear pad 122 includes a fluid trap (e.g., a cut out area, opening, recessed portion, or other suitable structure) configured to collect fluid that may drip out of the ear canal EC during use.
  • the fluid trap can be located in a section of the ear pad 122 under the delivery element 110.
  • the sidewalls of the fluid trap can be configured to contain any fluid that drips out of the ear canal EC while the device is held upright. As such, a healthcare professional can finish a cleaning procedure and then remove the device while holding it upright to avoid leakage of any fluid that has been collected in the fluid trap.
  • the ear pad 122 can include a hollow interior, and a hole or opening can allow excess fluid that drips out of the ear canal EC during a cleaning procedure to drip through the hole and be collected in the hollow interior of the ear pad 122.
  • Inlet channel 112 may include, for example, one or more fluid delivery apertures or ports to enable and facilitate fluid communication from inlet channel 112 to ear canal EC for introducing and applying fluid (e.g., having cleaning agent) to ear canal EC under pressure.
  • inlet channel 112 may be configured based on parameters relating to, for example, flow rate, flow type (e.g., laminar, turbulent, etc.), dimensions, shape, and the like.
  • Inlet channel 112 may be connected to inlet path 116 by way of coupling 105 for fluid communication with fluid reservoir 120 by way of coupling 104.
  • inlet channel 112 may be dimensioned for integration with or coupling to delivery element 110.
  • inlet channel 112 may be embedded in or coupled to delivery element 110.
  • inlet channel 112 may be fluidly connected to or otherwise formed as a part of delivery element 110 in any suitable manner to enable delivery and application of fluid to ear canal EC.
  • Discharge channel 114 may include, for example, one or more fluid discharge apertures or ports to enable and facilitate fluid communication from ear canal EC to discharge channel 114 for receiving and discharging applied fluid from ear canal EC (e.g., for disposal in discharge reservoir 130).
  • discharge channel 114 may be configured based on parameters related to flow rate, flow type (e.g., laminar, turbulent, etc.), dimensions, shape, and the like.
  • discharge channel 114 may include a valve, such as a non-retum valve, check-valve 1-way valve, or the like, such as to prevent recirculation of applied fluid in ear canal EC.
  • discharge channel 114 may be connected to discharge path 118 by way of coupling 105 for fluid communication with discharge reservoir 130 by way of coupling 104.
  • Discharge channel 114 may be dimensioned for integration with or coupling to delivery element 110 such as in a manner similar to that described with reference to inlet channel 112.
  • discharge channel 114 may be fluidly connected to or otherwise formed as part of delivery element 110 in any suitable manner to enable receipt and discharge of applied fluid from ear canal EC.
  • Fluid reservoir 120 may be configured to contain a first volume of fluid such as a liquid, e.g., a liquid including a cleaning agent for irrigation and cleaning of a user’s auditory canal (e.g., ear canal EC).
  • the cleaning agent can include, for example, an antimicrobial agent, an antifungal agent, an antibacterial agent, an acidic agent, an alkaline agent, a neutral agent, etc.
  • the liquid can include a buffer solution for maintaining a specific pH.
  • the fluid cleaning agent may include, for example, water, a saline solution, and/or a hydrogen peroxide solution.
  • the fluid reservoir 120 may connect to inlet path 116 by way of coupling 104, and inlet path 116 may connect to inlet channel 112 by way of coupling 105 to establish fluid communication therebetween.
  • Fluid reservoir 120 may be or include, for example, a reservoir, container, or the like.
  • the fluid reservoir 120 may be disposable or recyclable.
  • the fluid may alternatively or additionally include, for example, an antibacterial agent, an antibiotic agent, or the like.
  • fluid reservoir 120 may be configured to heat a contained supply of fluid cleaning agent to, for example, a temperature range having limits substantially equal to, above, and/or below body temperature (e.g., of a user), such as to support a comfort level of the user during use of the irrigation device 100.
  • the fluid reservoir 120 may include, for example, a heating component such as a heater or resistive element configured to heat and maintain the contained supply of fluid at a predefined (e.g., user-selected) temperature.
  • the fluid reservoir 120 may be insulated.
  • the fluid reservoir 120 may include a temperature sensor such as a thermometer for measuring the temperature of a contained supply of fluid.
  • the cleaning agent reservoir 120 may be filled with a supply of cleaning agent at approximately body temperature.
  • the fluid reservoir 120 may be pre-filled (e.g., come pre-packaged with a supply of a fluid cleaning agent).
  • a user or someone e.g., a physician or other medical practitioner
  • administering the fluid cleaning agent can prepare and/or fill the fluid reservoir 120 with a supply of fluid cleaning agent.
  • the fluid reservoir 120 is configured to store sufficient fluid for performing at least one, at least two, at least three, at least four, at least five, at least about 10, at least about 20, or at least about 50 cleaning cycles, including all ranges and values therebetween.
  • the fluid reservoir 120 is configured to store about 50mL to about 150 mL, including all ranges and values therebetween. In some embodiments, the fluid reservoir 120 is configured to store about 140mL of fluid. In some embodiments, the fluid reservoir 120 includes an inlet configured to accept fluid, e.g., for filing the fluid reservoir before use. In some embodiments, the fluid reservoir may have an angled bottom surface (e.g., a ramp), e.g., for directing fluid toward a drain hole that connects to the inlet path 116 and inlet channel 112. This can be beneficial for patients (e.g., elderly, children) who may not be able to sit upright for extended periods of time, as the angled surface can direct the fluid toward the drainage hole.
  • a ramp e.g., for directing fluid toward a drain hole that connects to the inlet path 116 and inlet channel 112. This can be beneficial for patients (e.g., elderly, children) who may not be able to sit upright for extended periods of time, as the angled surface can
  • the discharge reservoir 130 may connect to a discharge path 118 by way of a coupling 104, and the discharge path 118 may connect to a discharge channel 114 by way of a coupling 105, to establish fluid communication therebetween.
  • the discharge reservoir 130 may include, for example, a container or reservoir for receiving and containing applied liquid or a second volume of fluid from a user’s auditory canal (e.g., for later disposal).
  • the fluid received by and contained in the discharge reservoir 130 may include a mixture of applied fluid having dislodged and entrained excessive ear wax from ear canal EC.
  • the discharge reservoir 130 may be disposable and/or recyclable.
  • the discharge reservoir 130 may be made of disposable and/or recyclable plastic materials.
  • the fluid reservoir 120 and/or the discharge reservoir 130 may be enclosed within one or more containers configured for removable attachment to the support element 103, as shown in FIG. 1.
  • the discharge reservoir 120b is configured to store the same volume of fluid as the fluid reservoir 120a (or a portion thereof). In some embodiments, the discharge reservoir 120b is larger than the fluid reservoir 120a, e.g., to accommodate for capture of ear wax or other debris from the ear canal EC.
  • the support element 103 may include a controller 150, an input/output (VO) or user interface 160 (“I/O interface 160” or “user interface 160”), an inlet path 116, and a discharge path 118.
  • VO input/output
  • I/O interface 160 user interface 160
  • the support element 103 may be configured, sized, and shaped to fit on, over, or about an ear of a user at a position adjacent to auricle to facilitate mounting of delivery element 110 in ear canal EC, and further, to facilitate establishing and maintaining fluid communication between fluid reservoir 120 and inlet channel 112 as well as between discharge reservoir 130 and discharge channel 114, respectively.
  • inlet path 116 may be connected at a proximal end to fluid reservoir 120 by way of a first fluid coupling (e.g. coupling 104), and at a distal end to inlet channel 112 by way of a second fluid coupling (e.g. coupling 105), as shown in FIG. 1.
  • discharge path 118 may be connected at a proximal end to discharge reservoir 130 by way of a third fluid coupling (e.g. of coupling 104), and at a distal end to inlet channel 112 by way of a fourth fluid coupling (e.g. of coupling 105), as shown in FIG. 1.
  • Each coupling 104 and 105 may include one or more suitable fluid interfaces, adaptors, fittings, couplings, and the like.
  • Coupling 104 may include the first and third fluid couplings and coupling 105 may include the second and fourth fluid couplings.
  • couplings 104 and/or 105 may include peripheral components for confirming connections, such as between one or more of inlet channel 112, inlet path 116, and/or fluid reservoir 120, as well as between discharge channel 114, discharge path 118, and/or discharge reservoir 130.
  • couplings 104 and/or 105 may include components that generate an auditory signal (e.g., a “click” noise), a haptic signal, a visual signal, and/or otherwise indicate proper coupling between the different components of the ear cleaning device 100.
  • the controller 150 may be configured to provide control to a user over the operations of the ear cleaning device 100.
  • the controller 150 may include any suitable type of controller or processor.
  • the controller 150 may be connected to the I/O interface 160 for data communications.
  • the controller 150 and the I/O interface 160 may be coupled for data communications.
  • the controller 150 may be configured to send, receive, transmit or otherwise communicate data (e.g., user input data, operational status data, etc.) to and from VO interface 160.
  • the data communications between the controller 150 and the I/O interface 160 may be transmitted via wired, wireless, or fiber optic connections.
  • the controller 150 may include control circuitry (not depicted) for communicating and/or executing machine-executable program instructions (e.g., as may be stored on machine-readable storage media).
  • the controller 150 may execute a set of machine-executable instructions corresponding to an ear cleaning operation or procedure, such as may be stored on machine-readable storage media, upon command by a user.
  • the ear cleaning device 100 may be controlled (e.g., by a user) by way of the controller 150 and the VO interface 160 with respect to a target treatment volume or area, such as the space or surface in, about, or along ear canal EC and/or auricle AR.
  • the I/O interface 160 may be configured to receive user inputs and commands from a user.
  • the I/O interface 160 may include, for example, a button, switch, touch screen, and/or any other suitable actuation mechanism to receive the user inputs and commands.
  • the VO interface 160 may additionally or alternatively include, for example, a display or screen (not depicted) for displaying feedback such as device or operational status to the user, such as with respect to irrigation operation to be performed, and the like.
  • the I/O interface 160 may be electrically and communicatively coupled to the controller 150 for data communications.
  • the data communications may include, for example, user inputs received by the I/O interface 160 from the user, which may be communicated or sent to the controller 150 for execution in performing a user-selected ear cleaning operation.
  • the user inputs may include, for example, selections of one or more of a plurality of irrigation programs (e.g., respectively stored as sets of processor-executable instructions on one or more memories).
  • the I/O interface 160 may include a touchscreen device.
  • the touchscreen device may be configured to, for example, receive user inputs from and provide feedback to the user such as by way of a display to facilitate user selection, adjustment, and configuration of irrigation operations to be performed by the ear cleaning device 100.
  • the touchscreen device of the I/O interface 160 may be configured to render and display one or more graphical user interface symbols or elements resembling one or more corresponding user interface elements, such as buttons, scales, bars, panels, switches, or any other user interface element corresponding to a control signal or user-selectable input or command.
  • the ear cleaning device 100 may include a power supply 170, a pump assembly 124, and a vacuum assembly 126.
  • the power supply 170 may be configured to store and supply power to various powerconsuming components of the ear cleaning device 100, such as the controller 150, the I/O interface 160, the pump assembly 124, and/or the vacuum assembly 126.
  • the power supply 170 may include a portable power source such as a battery, or the like, having a power storage capacity sufficient to supply power to the power-consuming components of the ear cleaning device 100 for performance of an irrigation operation.
  • the ear cleaning device 100 can be configured for induction charging, e.g., to allow for charging / re-charging of the onboard power supply 170.
  • the pump assembly 124 may include any suitable pneumatic, hydraulic, or mechanical pump configured to move fluid from the fluid reservoir 120 to the ear canal EC under pressure (e.g. at a positive pressure greater than one atmosphere, or ambient pressure).
  • the pump assembly 124 may be configured to couple to fluid reservoir 120, inlet path 116, and inlet channel 112 to move a supply of fluid from the fluid reservoir 120 to the ear canal EC under a preset pressure and/or at a preset flow rate.
  • the pump assembly 124 may include a positive displacement pump such as a peristaltic pump, a diaphragm pump, or the like.
  • the pump assembly 124 may be configured to move the supply of fluid in conjunction with one or more peripheral devices such as pressure storage reservoir (e.g., a hydraulic accumulator), flowcontrol valves, an energy storage device such as an internal, elastic diaphragm positioned in the fluid reservoir 120, and the like.
  • peripheral devices such as pressure storage reservoir (e.g., a hydraulic accumulator), flowcontrol valves, an energy storage device such as an internal, elastic diaphragm positioned in the fluid reservoir 120, and the like.
  • the vacuum assembly 126 may include, for example, a vacuum or suction pump (e.g., a scroll pump) or any other suitable type of pump for generating and applying a vacuum or suction (e.g., at negative pressure less than one atmosphere or ambient pressure), such as with respect to the discharge reservoir 130, to draw fluid from the ear canal EC.
  • Vacuum assembly 126 may couple to discharge reservoir 130, discharge path 118, and discharge channel 114 to apply the vacuum to ear canal EC for discharge and receipt of previously applied fluid, having dislodged and entrained excessive ear wax from ear canal EC.
  • ear cleaning device 100 does not include a vacuum assembly 126, and in such implementations, fluid may drain from the ear, e.g., due to a pressure differential between the ear canal EC and one or more of the discharge channels 114, discharge path 118, and discharge reservoir 130. Such a pressure differential can result from the delivery of pressurized fluid into the ear canal EC and/or due to a pre-set vacuum within discharge reservoir 130.
  • ear cleaning device 100 can be coupled to a vacuum that can draw fluid out from the ear via discharge channel 114 and/or another fluid path (not depicted).
  • a vacuum can be coupled to discharge reservoir 130 to generate a vacuum for withdrawing fluid from the ear canal EC.
  • a device e.g., ear cleaning device 100 to irrigate ear canal(s) of human ear(s) (e.g., auricle and ear canal EC) may include a first overear earpiece (e.g., support element 103) sized and dimensioned to be worn over human ears and having a cavity sized and dimensioned to receive one human ear.
  • the device e.g., ear cleaning device 100
  • the device may further include a first cleaning interface (e.g., delivery element 110) to which one or more cleaning agent delivery elements are selectively, detachably, and physically couplable.
  • the device e.g., the ear cleaning device 100
  • the device e.g., ear cleaning device 100
  • the device may be implemented by a user (e.g., via I/O interface 160) to perform (e.g., via controller 150) an ear cleaning operation or procedure to clean the auricle and the ear canal EC by irrigation and removal of excessive ear wax.
  • FIG. 2 is a schematic diagram depicting an ear cleaning or irrigation device 200, according to an embodiment.
  • the ear cleaning device 200 may include, for example, first and second earsets or over-ear earpieces 201a and 201b (collectively, “earset(s) 201” or “over-ear earpiece(s) 201”), connected to one another by a support element 203.
  • the over-ear earpieces 201a and 201b may respectively include first and second delivery elements 210a and 210b (collectively, “delivery element(s) 210”), configured for respective insertion and mounting in first and second ear canals EC, first and second fluid reservoirs 220a and 220b (collectively, “fluid reservoir(s) 220” or “cleaning agent reservoir(s) 220” or “fluid cleaning agent reservoir(s) 220”), and first and second discharge reservoirs 230a and 230b (collectively, “discharge reservoir(s) 230”).
  • the over-ear earpieces 201 and/or the support element 203 may be similar in structure, form, and/or function to that of the ear cleaning device 100 and the support element 103, as described with reference to FIG. 1.
  • the earsets 201 represent, for example, individual ear cleaning devices such as that described with reference to FIG. 1.
  • the earsets 201 may be operably connected to one another by the support element 203, as shown in FIG. 2, and may be configured for concurrent or individual use in cleaning ear canals EC - simultaneously or one at a time - by irrigation and removal of excessive ear wax.
  • the ear cleaning device 200 may be worn on or by a user by positioning the support element 203 atop head HD and adjacent auricles, and mounting delivery elements 210 in the ear canals EC, to clean the ear canals EC simultaneously or one at a time by irrigation and removal of excessive ear wax therefrom.
  • the earsets 201 may be similar in structure, form, and/or function.
  • the first earset 201a may include delivery element 210a, fluid reservoir 220a, and discharge reservoir 230a
  • the second earset 201b may include delivery element 210b, and in some optional instances, fluid reservoir 220b, and discharge reservoir 230b.
  • the fluid reservoirs 220, the discharge reservoirs 230, and the delivery elements 210 may be analogous (e.g., as in structure, form, or function) to the fluid reservoir 120, the discharge reservoir 130, and the delivery element 110, as described with reference to FIG. 1.
  • the earsets 201 may respectively include one or more of the components described with reference to the ear cleaning device 100, including, for example, the ear pad 122, the controller 150, the VO interface 160, the power supply 170, the pump assembly 124, and/or the vacuum assembly 126.
  • the earsets 201 may each respectively include a vertical axis (not depicted) oriented substantially perpendicular to the ground when a user wearing ear cleaning device 200 is in an upright position, and a horizontal or lateral axis oriented substantially parallel to the ground when the user wearing ear cleaning device 200 is in the upright position. While discussed with respect to an upright position for ease of reference, it should be noted that a user does not necessarily need to be in an upright position during use of ear cleaning device 200.
  • the earsets 201 may be operably connected to one another, for example, by way of respective fluid couplings and one or more fluid communication paths 211.
  • the one or more fluid communication paths 211 may be configured to enable fluid communication between the delivery element 210b and the fluid reservoir 220a as well as the discharge reservoir 230a.
  • the first fluid reservoir 220a may include a fluid capacity sufficient to contain a supply of fluid for performing an irrigation operation (e.g., at least 70 milliliters), in which the fluid is delivered into both the first and second ear canals EC of a user via respective delivery elements 210a and 210b.
  • the first discharge reservoir 230a may include a fluid capacity equal to or greater than that of the fluid reservoir 220a, to contain applied fluid removed from both the first and second ear canals EC of the user via the respective delivery elements 210a and 210b during the irrigation operation.
  • the delivery element 210b may additionally or alternatively be configured for fluid communication with the fluid reservoir 220b and the discharge reservoir 230b.
  • the one or more fluid communication paths 211 may be configured to alternatively or additionally enable fluid communication between the delivery element 210b and the fluid reservoir 220b as well as the discharge reservoir 230b.
  • the irrigation of and removal of excessive ear wax from the first ear canal EC may include, for example, delivering fluid under pressure from the first fluid reservoir 220a to the first ear canal EC by way of the first delivery element 210a, as shown in FIG. 2.
  • the irrigation of and removal of excessive ear wax from the first ear canal EC may further include, for example, removing, by way of the first delivery element 210a, the delivered and applied fluid from the first ear canal EC for disposal in the discharge reservoir 230a.
  • the irrigation and removal of excessive ear wax from the second ear canal EC may include, for example, delivering fluid under pressure from the first and/or second fluid reservoirs 220a and 220b to the second ear canal EC by way of the second delivery element 210b.
  • the irrigation of and removal of excessive ear wax from the second ear canal EC may further include, for example, removing, by way of the second delivery element 210b, the delivered and applied fluid from the second ear canal EC for disposal in the first and/or second discharge reservoirs 230a and 230b.
  • ear cleaning device 200 may be anatomically sized to fit various users, such as with respect to various anatomical sizes of and/or spatial relations between head HD, and/or ear canal EC, as shown in FIG. 2.
  • the support element 203 may include, for example, an adjustable (e.g., deformable or flexible) head strap, one or more vertical adjustors (not depicted), and one or more pivot couplers (not depicted) to enable and facilitate adjustment and variation of the relative spatial positions of the first and second earsets 201 by a user.
  • the adjustment and variation of the relative spatial positions of the first and second earsets 201 may include, for example, lateral or horizontal displacement of the first or second earsets 201 with respect to a lateral axis extending between points on the first and second earsets 201, vertical displacement of the first or second earsets 201 with respect to a vertically-oriented axis, and the like.
  • the ear cleaning device 200 may be configured to accommodate various head shapes and sizes of various users (e.g., various circumferential distances between the ears of the various users) by enabling selective spatial positioning and fitting adjustment of the first and second earsets 201.
  • the one or more pivot couplers with which each earset 201 may individually and respectively couple or connect may be configured to enable and facilitate independent rotational displacement (“rotational displacement” or “rotational motion” or “pivoting motion” or “pivotal motion”) of each earset 201 about respective, spaced-apart axes. Accordingly, the pivot couplers may be configured to enable and facilitate more comfortable and individualized fit of the earsets 201 on various users, by accommodation of the unique contours and shapes of individual user’s heads.
  • the first and second earsets 201a-b may include respective annular brackets (not depicted).
  • Each annular bracket may be individually sized and shaped to be slightly larger than a portion of a perimeter of a respectively associated earset (e.g., the first earset 201a or the second earset 201b).
  • a first annular bracket may be sized and shaped to run along the top half of the perimeter of a respectively associated earset including the first earset 201a
  • a second annular bracket may be sized and shaped to run along the top half of the perimeter of a respectively associated earset including the second earset 201b.
  • Each annular bracket may be pivotally coupled to support element 203 at and by way of a junction, interface, or physical coupling, to enable and facilitate independent, rotational motion of the first and second earsets 201a-b.
  • FIG. 3 is a front view of an ear cleaning device 300, according to an embodiment.
  • the ear cleaning device 300 is depicted on a stand in FIG. 3, though it can be appreciated that in use the ear cleaning device 300 would be positioned over a head of a patient.
  • the ear cleaning device 300 is functionally and/or structurally similar to the ear cleaning device 100 of FIG. 1 and/or the ear cleaning device 200 of FIG. 2.
  • the ear cleaning device 300 may include a first and second over-ear earpieces or earsets 301a and 301b (collectively, “over-ear earpiece(s) 301 or “earset(s) 301”) (e.g., functionally and/or structurally similar to the earsets 201 and 201b of FIG. 2), a support element 303 (e.g., structurally and/or functionally similar to the support element 103 of FIG. 1 and/or the support element 203 of FIG. 2), a first and second delivery element 310a and 310b (collectively, “delivery element(s) 310) (e.g., structurally and/or functionally similar to the delivery element 110 of FIG.
  • a first and second over-ear earpieces or earsets 301a and 301b collectively, “over-ear earpiece(s) 301 or “earset(s) 301”
  • a support element 303 e.g., structurally and/or functionally similar
  • first and second fluid reservoir 320a and 320b collectively, “fluid reservoir(s) 320” (e.g., functionally and/or structurally similar to the fluid reservoir 120 of FIG. 1 and/or the fluid reservoir(s) 220 of FIG. 2), a first and second discharge reservoir 330a and 330b (collectively, “discharge reservoir(s) 330) (e.g., functionally and/or structurally similar to the discharge reservoir 130 of FIG. 1 and/or the discharge reservoir 230 of FIG.
  • fluid reservoir(s) 320 e.g., functionally and/or structurally similar to the fluid reservoir 120 of FIG. 1 and/or the fluid reservoir(s) 220 of FIG. 2
  • discharge reservoir(s) 330 e.g., functionally and/or structurally similar to the discharge reservoir 130 of FIG. 1 and/or the discharge reservoir 230 of FIG.
  • ear pad(s) 322 a first and second ear pad 322a and 322b (collectively, “ear pad(s) 322)) (e.g., functionally and/or structurally similar to the ear pad 122 of FIG. 1.
  • the fluid reservoir(s) 320 and the discharge reservoir(s) 330 from fluid containers.
  • the ear cleaning device 300 may be sized and shaped such that the first over-ear earpiece 301a fits over a user’s right ear, and the second over-ear earpiece 301b fits over the user’s left ear.
  • the ear cleaning device 300 may be sized and shaped such that the first over-ear earpiece 301a fits over a user’s right or left ear, and the second over-ear earpiece 301b fits over the user’s left or right ear.
  • each over-ear earpiece 301 may be sized and shaped for interchangeable fit over either of a user’s right and left ears.
  • the ear cleaning device 300 is worn on the head of the user such that the support element 303 curves around the top of the head of a user. In some embodiments, the ear cleaning device 300 may be worn while a user is standing, seated, reclining, or laying down.
  • the second earpiece 301b includes an input/output interface 360 (e.g., functionally and/or structurally similar to the input/output interface 160 of FIG. 1).
  • the input/output interface 360 can include an input button that a user can user to power on, power off, and/or operate the ear cleaning device 300. In some embodiments, the input/output interface 360 is operatively coupled to a controller such as the controller 150 of FIG. 1. In some embodiments, the input/output interface 360 can include a device (e.g., light, speaker, etc.) configured to communicate information (e.g., status, battery life, operating condition, etc.) to the user.
  • a device e.g., light, speaker, etc.
  • the containers including the fluid reservoirs 320 and the discharge reservoirs 330 are coupled to the earsets 301 via a first and second coupling 304a and 304b (collectively, “coupling(s) 304”) (e.g., structurally and/or functionally similar to the coupling 104 of FIG. 1).
  • the coupling(s) 304 can be a clip, a pin, press fit, and/or the like.
  • the coupling(s) 304 is configured to support the weight of the containers and the fluid within the fluid reservoir(s) 320 and the discharge reservoir(s) 330.
  • the containers and the earsets 301 can form a seal so that any fluid stored in the fluid reservoir(s) 320 and the discharge reservoir(s) 330 does not leak out.
  • a single unitary container can be used, with the fluid reservoir(s) 320 and the discharge reservoir(s) 330 defined by different portions of the container.
  • the containers can be radially larger than the earset 301b. This can facilitate gripping and/or holding of the device while putting it on or taking it off of a user.
  • the containers can store sufficient fluid for multiple cleaning cycles (e.g., at least about 2, at least about 3, at least about 4, at least about 5, at least about 10, etc.).
  • the fluid reservoir(s) 320 can include a fluid inlet 324 which can be used to fill the fluid reservoir(s) 320 with fluid.
  • the fluid inlet 324 can be a one-way valve that only allows fluid to be filled into the fluid reservoir(s) 320 and prevents fluid from leaving or leaking out of the fluid reservoir(s) 320.
  • the discharge reservoir(s) 330 can include an outlet 332 configured to allow fluid and/or debris to be drained out of the discharge reservoir(s) 330.
  • the outlet 332 can include a plug so that fluid and/or debris only leaves the discharge reservoir(s) 330 when the plug is removed.
  • FIG. 5A is a front view of an ear cleaning device 500 engaging a head HD of a patient, according to an embodiment.
  • the ear cleaning device 500 can be functionally and/or structurally similar to the ear cleaning device 100 of FIG. 1, the ear cleaning device 200 of FIG. 2, and/or the ear cleaning device 300 of FIGS. 3A-3B.
  • the earpiece 501 of the ear cleaning device 500 is structurally and/or functionally similar to any of the earpieces described herein, such as the earpieces 201 of FIG. 2 and/or the earpieces 301 of FIGS. 3A- 3B.
  • the ear cleaning device 500 includes a support element 503 (e.g., structurally and/or functionally similar to the support element 103 of FIG. 1, the support element 203 of FIG. 2, and/or the support element 303 of FIG. 3), a fluid reservoir 520 (e.g., structurally and/or functionally similar to the fluid container 120 of FIG. 1, the fluid reservoir(s) 220 of FIG. 2, and/or the fluid reservoirs(s) 320 of FIGS. 3A-3B), a discharge reservoir 520 (e.g., structurally and/or functionally similar to the discharge container 120 of FIG. 1, the discharge reservoir(s) 220 of FIG. 2, and/or the discharge reservoirs(s) 320 of FIGS.
  • a support element 503 e.g., structurally and/or functionally similar to the support element 103 of FIG. 1, the support element 203 of FIG. 2, and/or the support element 303 of FIG. 3
  • a fluid reservoir 520 e.g., structurally and/or functionally similar to
  • an ear pad 522 e.g., functionally and/or structurally similar to the ear pad 122 of FIG. 1, the ear pad(s) 222 of FIG. 2, and/or the ear pad(s) 322 of FIGS. 3A-3B
  • a delivery element 510 e.g., structurally and/or functionally similar to the delivery element 110 of FIG. 1, the delivery element(s) 210 of FIG. 2, and/or the delivery element(s) 310 of FIGS. 3A-3B.
  • the earpiece 501 is worn by the patient such that the delivery element 510 engages an auricle and ear canal of the patient’s head HD.
  • the ear pad 522 presses against the head HD, providing the patient with a soft cushion and controls the depth that the delivery element 510 enters into the ear canal.
  • the ear pad 522 defines a cavity or space for receiving the ear.
  • the ear pad 522 can have a recessed or windowed portion 522a.
  • the windowed portion 522a allows for a user (e.g., healthcare professional) to see the delivery element 510 being inserted into the ear canal. This allows for the user to properly position the delivery element 510 and to observe the delivery element 510 during operation.
  • the earpiece 501 includes a light source configured to illuminate the space visible through the windowed portion 522a.
  • the ear pad 522 can include two windowed portions 522a, e.g., for viewing from either side of the device.
  • the ear pad 522 can include one windowed portion 522a, e.g., for viewing from a front side of the device.
  • the windowed portion 522a can be a cutout or recess in the ear pad 522 that provides a line of sight into the cavity or space for receiving the ear of the patient. The line of sight can allow the user to confirm whether the delivery element 510 has been placed within the ear canal of the patient.
  • the windowed portion 522a can include a translucent or transparent portion of the ear pad 522.
  • the ear pads 522 of the ear cleaning device 500 can be made from a transparent or translucent material.
  • the ear pad 522 is configured to prevent the delivery element 510 from entering into the ear canal past a predetermined depth. As seen in FIG. 6B, the ear pad 522 defines a first width 522c and a second width 522d. In some embodiments, as seen in FIG. 6B, the second width 522d is greater than the first width 522c as to accommodate the shape of the head HD. In some embodiments, the length of the windowed portion 522a is about 10% to about 40% of an outer perimeter of the ear pad 522.
  • FIGS. 5B-5C depict different views of ear cleaning device 500 of FIG. 5A.
  • the ear pads 522 include a drip catch or trap 522b.
  • the drip catch 522b is an area of the lower section of the ear pad 522 directly under the delivery element 510.
  • the drip catch 522b can be located at an inferior side of the ear pad 522.
  • the drip catch 522b can be located below the ear canal such that fluids that escape or leak out of the ear canal can be captured by the drip catch.
  • the drip catch 522b can catch fluid that may drip out of the ear canal. As seen in FIG.
  • the drip catch can extend in the ear pad 522 from one windowed portion 522a to the other windowed portion 522a.
  • the drip catch 522b can include a drain or an outlet configured to drain fluid from the drip catch 522b, e.g., into the ear pad 522 or through the device and into a discharge reservoir or other reservoir.
  • FIGS. 7A-7D and 8A-8D depict different configurations of delivery elements or ear tips of ear cleaning devices, according to embodiments.
  • the long ear tip 710 is structurally and/or functionally similar to the delivery elements described herein, such as the delivery element 110 of FIG. 1, the delivery elements 210 of FIG. 2, the delivery elements 310 of FIG. 3, and/or the delivery elements 510 of FIGS. 5A-5C.
  • the long ear tip 710 is configured to be inserted into an ear canal at or slightly past the isthmus of the ear canal and is intended to remove earwax that is more medial (e.g., deeper) in the ear canal.
  • the long ear tip 710 can come in different sizes, e.g., to accommodate different sized ear canals. For example, there can be a regular configuration for regular to large diameter ear canals and a small configuration for small diameter ear canals.
  • the long ear tip 710 is disposable and/or recyclable.
  • the long ear tip 710 is flexible or deformable and can be configured to deform to the shape of an ear canal.
  • FIG. 7A depicts a perspective view of the long ear tip 710.
  • the long ear tip 710 includes a body 710a, a tab or clip 710b, an inlet channel 712 (e.g., structurally and/or functionally similar to the inlet channel 112 of FIG. 1), and a discharge channel 714 (e.g., structurally and/or functionally similar to the discharge channel 114 of FIG. 1).
  • the body 710a is configured to engage an earset, such as the earsets 201 of FIG. 2, the earsets 301 of FIGS. 3A-3B, and/or the earsets 501 of FIGS. 5A-5B.
  • the clip 701b allows for the body 710a to be removed from engagement with an earset.
  • the clip 701b can allow for replacement, maintenance, cleaning, and/or the like.
  • the clip 710b is angled away from the proximal end of the long ear tip 710 so that a user can grab the clip 710b to remove the long ear tip 710.
  • the ear tip 710 can also include tabs or ridges at its proximal end for engaging with and coupling to a ridge or similar structure on an earset.
  • the inlet channel 712 is configured to receive fluid from a fluid reservoir, such as any one of the fluid reservoirs described herein, and direct the fluid into the ear canal.
  • the inlet channel 712 includes an opening at the proximal end of the long ear tip 710 for receiving the fluid and directs the fluid to the distal end, as seen in FIG. 7C.
  • a nozzle 712a At the distal end of the inlet channel 712 is a nozzle 712a.
  • the nozzle 712a includes three openings configured to direct fluid in different directions.
  • the nozzle 712a can include any number of openings in any configuration (e.g., location, size, etc.) based on the intended use of the long ear tip 710.
  • the nozzle 712a can include between about 2 and about 10 openings, including all ranges and values therebetween.
  • the discharge channel 714 is configured to receive discharged fluid through an opening 714a from the ear canal and direct the discharged fluid to a discharge reservoir, such as any one of the discharge reservoirs described herein.
  • the discharge channel 714 includes an opening at the proximal end of the long ear tip 710 for directing fluid from the opening 714a through the discharge channel 714 to the discharge reservoir.
  • the discharge channel opening 714 may be circular.
  • the opening 714 may be an ellipse.
  • the diameter, or the major axis of the opening 714 may be about 3 mm to about 5 mm.
  • the outer body of the ear tip 710 can be curved such that a proximal end of the ear tip 710 is set at an angle Al relative to the distal end of the ear tip 710.
  • both the inlet channel 712 and the discharge channel 714 can be curved according to the angle Al.
  • the angle Al is defined as the angle between a central longitudinal axis of the proximal end of the long ear tip 710 and a central longitudinal axis of the distal end of the long ear tip 710.
  • the angle Al can be between about 10 and about 50 degrees, including all ranges and values therebetween. In an embodiment, the angle Al can be at least about 10 degrees.
  • the angle Al can be selected to generally conform to the anatomical shape of an ear canal of a patient population (e.g., an adult male population, an adult female population, a pediatric population, etc.).
  • the inlet channel 712 and the discharge channel 714 can have a gradual curve from the distal end to the proximal end of the long ear tip 710.
  • the inlet channel 712 and the discharge channel 714 can be angled linearly, e.g., from a proximal end to a distal end of the ear tip 710 (or portions thereof).
  • the curvature of the long ear tip 701 can correspond to or substantially match the curvature of the ear canal, e.g., for being able to reach deeper into the ear canal to clean those regions.
  • the curve of the body of the ear tip may be customized to the anatomical shape of the ear canal of a patient.
  • the body of the ear tip 710 can also be tapered, e.g., from a proximal end to a distal end, to substantially correspond to or match the shape of a standard ear canal.
  • the inlet channel 712 terminates at the nozzle 712a, which is extends more distally than the discharge channel 714.
  • the nozzle 712a can be disposed deeper into the ear canal than the discharge channel 714. This can be beneficial to ensure that fluid exiting the nozzle 712a is delivered into the ear canal, e.g., for contacting and dislodging or breaking ear wax, before it is captured and discharged through the discharge channel 714.
  • the smaller diameter of the nozzle openings 712a can also increase a fluid flow rate out of the nozzle 712a such that the exiting fluid is jetted into the ear canal to dislodge or break ear wax.
  • the multiple openings of the nozzle 712a, as described in FIGS. 10A-10D, can facilitate an even distribution of fluid delivery and more effective cleaning of the ear canal.
  • FIGS. 8A-8D depict a short ear tip 810, according to an embodiment.
  • the short ear tip 810 is structurally and/or functionally similar to the delivery elements described herein, such as the delivery element 110 of FIG. 1, the delivery elements 210 of FIG. 2, the delivery elements 310 of FIG. 3, the delivery elements 510 of FIGS. 5A- 5C, and/or the ear tip 710 of FIG. 7A-7D.
  • the short ear tip 810 is configured to be inserted into an ear canal at or slightly past the aperture of the ear canal and is intended to remove earwax that is more lateral (e.g., shallower) in the ear canal.
  • the short ear tip 810 is shorter than the long ear tip 710 to allow the short ear tip 810 to remove earwax from a more lateral portion of the ear canal than the long ear tip 710.
  • the short ear tip 810 can include a regular configuration for regular to large diameter ear canals and a small configuration for small diameter ear canals.
  • the short ear tip 810 is disposable and/or recyclable.
  • the long ear tip 810 is configured to deform to the shape of an ear canal.
  • FIG. 8 A depicts a perspective view of the short ear tip 810.
  • the short ear tip 810 includes a body 810a, a clip or tab 810b (e.g., structurally and/or functionally similar to the clip 710b), an inlet channel 812 (e.g., structurally and/or functionally similar to the inlet channel 112 of FIG. 1), and a discharge channel 814 (e.g., structurally and/or functionally similar to the discharge channel 114 of FIG. 1).
  • the body 810a is configured to engage an earset, such as the earsets 201 of FIG. 2, the earsets 301 of FIGS. 3A-3B, and/or the earsets 501 of FIGS. 5A-5B.
  • the clip 801b allows for the body 810a to be removed from engagement with an earset.
  • the ear tip 810 can also include tabs or ridges at its proximal end for engaging with and coupling to a ridge or similar structure on an earset.
  • the inlet channel 812 is configured to receive fluid from a fluid reservoir, such as any one of the fluid reservoirs described herein, and direct the fluid into the ear canal.
  • the inlet channel 812 includes an opening at the proximal end of the short ear tip 810 for receiving the fluid and directs the fluid to the distal end, as seen in FIG. 8C.
  • a nozzle 812a At the distal end of the inlet channel 812 is a nozzle 812a.
  • the nozzle 812a includes three openings configured to direct fluid in different directions.
  • the nozzle 812a can include any number of openings in any configuration (e.g., location, size, etc.) based on the intended use of the short ear tip 810.
  • the nozzle 812a can include between about 2 and about 10 openings, including all ranges and values therebetween.
  • the discharge channel 814 is configured to receive discharged fluid through an opening 814a from the ear canal and direct the discharged fluid to a discharge reservoir, such as any one of the discharge reservoirs described herein.
  • the discharge channel 814 includes an opening at the proximal end of the long ear tip 810 for directing fluid from the opening 814a through the discharge channel 814 to the discharge reservoir.
  • the discharge channel opening 814 may be circular.
  • the opening 814 may be an ellipse.
  • the diameter, or the major axis of the opening 814 may be about 3 mm to about 5 mm.
  • the body of the ear tip 810 can be angled or curved. Given the shorter length of the ear tip 810 compared to the ear tip 710, the ear tip 810 can have a less pronounced angle or curve, depicted as A2.
  • the angle A2 is defined as the angle between a central longitudinal axis of the proximal end of the ear tip 810 and a central longitudinal axis of the distal end of the ear tip 810.
  • the angle A2 can be between about 5 and about 30 degrees, including all ranges and values therebetween.
  • the angle A2 can be at least about 5 degrees.
  • the inlet channel 812 and the discharge channel 814 can be angled from the distal end to the proximal end of the ear tip 810.
  • the inlet channel 812 and the discharge channel 814 can be curved.
  • the inlet channel 812 and the discharge channel 814 can be at a straight angle (or have portions that are at a straight angle).
  • the angle or curve of the body of the ear tip 810 may be customized to the anatomical shape of the ear canal of a patient.
  • FIGS. 9A-9D depict various ear tips (e.g., functionally and/or structurally similar to the delivery element 110 of FIG. 1, the delivery elements 210 of FIG. 2, the delivery element 310 of FIG. 3, the delivery elements 510 of FIGS. 5A-5C, the long ear tip 710 of FIGS. 7A- 7D, and/or the short ear tip 810 of FIGS. 8A-8D) engaging an ear canal, according to embodiments.
  • the ear canal in FIGS. 9A-9D has the same dimensions for demonstrating the differences between various ear tips.
  • the larger ear tips shown in FIGS. 9A-9B are configured for use with patient populations have larger ear canals
  • the smaller ear tips shown in FIGS. 9C-9D are configured for use with patient populations with smaller ear canals.
  • FIG. 9 A depicts a regular long ear tip 910a.
  • the regular long ear tip 910a is structurally and/or functionally similar to the long ear tip 710 of FIG. 7.
  • the regular long ear tip 910a when inserted into the ear canal, ends at the isthmus of the ear canal.
  • the regular long ear tip 910a is intended to remove earwax that is more medial in the ear canal.
  • the width of the regular long ear tip 910a can substantially fill the ear canal opening, which can reduce fluid leaks out of the ear canal during use of the regular long ear tip 910a.
  • FIG. 9B depicts a regular short ear tip 910b.
  • the regular short ear tip 910b is structurally and/or functionally similar to the short ear tip 810 of FIG. 8.
  • the regular short ear tip 910b when inserted into the ear canal, ends at the aperture of the ear canal.
  • the regular short ear tip 910b is intended to remove earwax that is more lateral in the ear canal.
  • the width of the regular short ear tip 910b can substantially fill the ear canal opening, which can reduce fluid leaks out of the ear canal during use of the regular long ear tip 910a.
  • FIG. 9C depicts a small long ear tip 910c.
  • the small long ear tip 910c is structurally and/or functionally similar to the long ear tip 710 of FIG. 7. As shown, the small long ear tip 910c can have a smaller width or profile such that it can be used for ear canals with smaller openings.
  • FIG. 9D depicts a small short ear tip 910d.
  • the small short ear tip 910d is structurally and/or functionally similar to the short ear tip 810 of FIG. 8. As shown, the small short ear tip 910d can have a smaller width or profile such that it can be used for ear canals with smaller openings.
  • FIGS. 10A-10D depict nozzles (e.g., structurally and/or functionally similar to the ear tip 712a of FIGS. 7A-7D and the ear tip 812a of FIGS. 8a-8D) of a various ear tips (e.g., functionally and/or structurally similar to the delivery element 110 of FIG. 1, the delivery elements 210 of FIG. 2, the delivery element 310 of FIG. 3, the delivery elements 510 of FIGS. 5A-5C, the long ear tips 710 of FIGS. 7A-7D, and/or the short ear tips 810 of FIGS. 8A-8D).
  • nozzles e.g., structurally and/or functionally similar to the ear tip 712a of FIGS. 7A-7D and the ear tip 812a of FIGS. 8a-8D
  • a various ear tips e.g., functionally and/or structurally similar to the delivery element 110 of FIG. 1, the delivery elements 210 of FIG. 2, the delivery element 310 of FIG.
  • the nozzles include openings that are angled to direct fluid towards a particular portion of the ear canal and/or to distribute fluid throughout the ear canal.
  • Other nozzles may be possible than those in FIGS. 10A-10D.
  • the nozzles can include different numbers, orientations, and/or shapes of openings to match the ear canal of the patient.
  • FIGS. 10A-10B depict a long ear tip 1010 (e.g., structurally and/or functionally similar to the long ear tip 710 of FIGS. 7A-7D).
  • a nozzle 1012a of the long ear tip 1010 includes three openings.
  • the angle of the top two openings and a longitudinal axis of the distal end of a fluid channel 1012 is defined as angle Al.
  • the angle Al is between about 10 degrees and about 50 degrees, including all ranges and values therebetween.
  • the angle Al is between about 15 to about 20 degrees, or about 18 degrees.
  • the angle between the bottom opening and the longitudinal axis of the distal end is defined as A2.
  • the angle A2 is between about 30 degrees and about 80 degrees, including all ranges and values therebetween. In some embodiments, the angle A2 is between about 55 and about 60 degrees, or about 58 degrees. As depicted in FIG. 10B, the angle between one opening and a vertical axis of the distal end of the long ear tip 1010 is defined as A3 and the angle between another opening and the vertical axis of the distal end is defined as A4. In some embodiments, the angle A3 and angle A4 are substantially equal. In some embodiments, the angle A3 and angle A4 are between about 20 degrees and about 60 degrees, including all ranges and values therebetween. In some embodiments, the angle A3 and the angle A4 are between about 40 to 50 degrees, or 45 degrees. In some embodiments, the third opening is in line with the vertical axis of the distal end.
  • FIGS. 10C-10D depict a short ear tip 1110 (e.g., structurally and/or functionally similar to the short ear tip 810 of FIGS. 8A-8D).
  • a nozzle 1112a of the short ear tip 1110 includes three openings. The three openings of the short ear tip 1110 can be different from that of the long ear tip 1010, e.g., due to the area of the ear canal that the short ear tip 1110 is designed to clean.
  • the angle of the top two openings and a longitudinal axis of the distal end of a fluid channel 1112 is defined as angle A5.
  • the angle A5 is between about 10 degrees and about 50 degrees, including all ranges and values therebetween. In some embodiments, the angle A5 is about 36 degrees.
  • the angle between the bottom opening and the longitudinal axis of the distal end is defined as A6.
  • the angle A6 is between about 30 degrees and about 80 degrees, including all ranges and values therebetween. In some embodiments, the angle A6 is about 40 degrees.
  • the angle between one opening and a vertical axis of the distal end of the short ear tip 1110 is defined as A7 and the angle between another opening and the vertical axis of the distal end is defined as A8.
  • the angle A7 and angle A8 are substantially equal.
  • the angle A7 and angle A8 are between about 20 degrees and about 60 degrees, including all ranges and values therebetween.
  • the angle A4 and the angle A4 are about 30 degrees.
  • the third opening is in line with the vertical axis of the distal end.
  • FIGS. 11 A-l 1C depict a discharge reservoir 1130 including a first portion 1130a and a second portion 1130b, according to an embodiment.
  • the discharge reservoir 1130 is structurally and/or functionally similar to any of the discharge reservoirs described herein, such as the discharge reservoir 130 of FIG. 1, the discharge reservoir(s) 230 of FIG. 2, the discharge reservoirs 330 of FIG. 3A, and/or the discharge reservoir 530 of FIG. 5 A.
  • the discharge reservoir 1130 is configured to store fluid discharged out of an ear canal during operation of an ear cleaning device, such as the ear cleaning device 100 of FIG. 1 and/or any ear cleaning device described herein.
  • the discharge reservoir 1130 is transparent or translucent so that a user can see the contents of the discharge reservoir 1130.
  • the discharge reservoir 1130 is formed when the first portion 1130a is engaged with the second portion 1130b.
  • the second portion 1130b is configured to be coupled to an earset (e.g., functionally and/or structurally similar to the earsets 201 and 201b of FIG. 2).
  • the first portion 1130a is removable so that the discharge reservoir 1130 can be cleaned and so that the fluid can be removed.
  • FIG. 11 A depicts a perspective view of the first portion 1130a.
  • the first portion 1130a includes a body 1131a with two recessed portion 1134 and an outlet 1132 (e.g., functionally and/or structurally similar to the outlet 332 of FIG. 3).
  • the body 1131a forms a cavity that is configured to store liquid.
  • the body 113 la is semi-circular and is configured to fit into an earset together with a fluid reservoir.
  • the recessed portions 1134 are configured to accept a portion of the second portion 1130b so that the first portion 1130a and the second portion 1130 are sealed together when engaged.
  • the outlet 1132 is configured to allow discharged fluid to exit the discharge reservoir 1130.
  • the outlet 1132 can be covered with a plug or valve configured to selectively allow or prevent discharged fluid from exiting the discharge reservoir 1130.
  • FIG. 1 IB depicts a perspective view of the second portion 1130b.
  • the second portion 1130b includes a body 1131b, earset fasteners 1136b, container fasteners 1136a, a vacuum port 1138, and a vacuum shield 1139 (or shield).
  • the body 113 lb is configured to match and engage with and fit into a recess in the earset.
  • the body 1131b may be coupled to the earset.
  • the body 1131b can be clipped into, fastened, or adhered to the earset.
  • the earset fasteners 1136b may be used to couple the second portion 1130b to the earset.
  • the container fasteners 1136b are configured to engage the recessed portions 1134 of the first portion 1130a to couple the first portion 1130a to the second portion 1130b.
  • the vacuum port 1138 can be configured to be connected to a vacuum source to remove air from the discharge reservoir 1130 to create a negative pressure for removing fluid from the ear canal, e.g., via the fluid discharge channel.
  • the vacuum shield 1139 extends away from the body 1131b and engages the first portion 1130a as to prevent fluid from being removed from the discharge reservoir and entering the vacuum source.
  • the shield extends from a first side of the reservoir to a second, opposing side of the reservoir, e.g., to prevent fluid from being removed from the discharge reservoir and entering the vacuum source.
  • a small slot in the vacuum shield 1139 allows for air to flow out of the discharge reservoir 1130 while preventing nearly all water from reaching the vacuum source via the vacuum port 1138.
  • the slot can be configured to allow air to pass therethrough such that the negative pressure can be generated in the second reservoir via the vacuum assembly while preventing liquid from passing therethrough (e.g., liquid including the liquid discharged from the ear canal, or the second volume of fluid).
  • FIG. 11C depicts a perspective view of the first portion 1130a and the second portion 1130b engage to form the discharge reservoir 1130.
  • the first portion 1130a and the second portion 1130b are sealed together via a sealant, press fit, gasket, and/or the like.
  • the discharge reservoir 1130 defines a volume for storing discharged fluid.
  • the ear cleaning devices described herein are example embodiments of suitable ear cleaning devices. While certain features and/or components may be described with respect to one or more of the ear cleaning devices and not others, it can be appreciated that such features and/or components can be incorporated into any of the ear cleaning devices described herein. Additional examples of ear cleaning devices are also described in U.S. Patent Application No. 16/235,469, titled “Ear cleaning devices and methods,” filed December 28, 2018, the disclosure of which is incorporated herein by reference. Features and/or components of such ear cleaning devices can also be used with any of the ear cleaning devices described herein.
  • references in the specification to “one embodiment,” “an embodiment,” “an example embodiment,” or the like, indicate that the embodiment described may include one or more particular features, structures, or characteristics, but it shall be understood that such particular features, structures, or characteristics may or may not be common to each and every disclosed embodiment of the present invention herein. Moreover, such phrases do not necessarily refer to any one particular embodiment per se. As such, when one or more particular features, structures, or characteristics is described in connection with an embodiment, it is submitted that it is within the knowledge of those skilled in the art to affect such one or more features, structures, or characteristics in connection with other embodiments, where applicable, whether or not explicitly described.
  • inventive concepts may be embodied as one or more methods, of which an example has been provided.
  • the acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

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Abstract

Systems, devices, and methods described herein provide for cleaning of an ear, e.g., to remove ear wax and other debris from within an ear canal. The systems, devices, and methods can include one or more delivery elements with curved bodies and/or ear pads with recessed portions.

Description

EAR CLEANING DEVICES
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63/503,666, filed May 22, 2023, titled “EAR CLEANING DEVICES AND METHODS,” the disclosure of which is incorporated herein by reference.
TECHNICAL FIELD
[0002] The present disclosure relates generally to an ear cleaning device, and specifically to systems, devices, and methods for irrigating an ear canal of a subject.
BACKGROUND
[0003] Ear wax, also known as cerumen, naturally forms in the outer portion of a person’s ear and serves to protect and lubricate the ear canal or auditory canal. The motion of a person’s jaw assists in moving old ear wax towards the outside of the auditory canal where it dries up and falls away. Unfortunately, ear wax may build up in the auditory canal to the point that it impacts a person’s hearing. For example, built-up ear wax may accumulate at any point in or about the auditory canal, and at any point on or along a surface of the auditory canal. Some people may attempt to clean their ears with physical objects, such as cotton swabs, that can generally push ear wax deeper into the auditory canal towards the ear drum. For this reason, attempting to clean the auditory canal with such objects can actually harm a person’s hearing without providing any substantial benefit. Due to the drawbacks of existing systems and methods, it is desirable to have a device for cleaning an ear of a person that effectively removes ear wax from the ear canal without such drawbacks.
SUMMARY
[0004] Systems, devices, and methods described herein provide for cleaning of an ear, e.g., to remove ear wax and other debris from within an ear canal.
[0005] In some embodiments, an apparatus can include a support structure including a coupling element detachably couplable to a delivery element and defining a cavity configured to receive an ear of a subject; a first reservoir couplable to the support structure and configured to contain a first volume of fluid; a first channel configured to provide fluid communication between the first reservoir and the coupling element such that the first volume of fluid can be delivered from the first reservoir to the coupling element; a second reservoir couplable to the support structure and configured to receive a second volume of fluid; a second channel configured to provide fluid communication between the second reservoir and the coupling element such that the second volume of fluid can be received in the second reservoir from the coupling element; and a delivery element coupled to the coupling element, the delivery element having a body that curves from a proximal end to a distal end of the delivery element.
[0006] In some embodiments, an apparatus can include a curved body configured to be inserted into an ear canal, the curved body having a proximal end that is angled relative to a distal end by an angle of between about 10 degrees and about 50 degrees, the curved body having a first portion that defines an inlet channel and a second portion that defines an outlet channel, the inlet and the outlet channels being curved from the proximal end to the distal end of the curved body; and a nozzle disposed at a distal end of the curved body, the nozzle including at least three openings configured to dispense fluid streams at different angles.
[0007] In some embodiments, an apparatus can include a support structure; an ear pad coupled to the support structure, the ear pad defining a cavity for receiving an ear of a subject when the ear pad is placed against a head of the subject, the ear pad including: a windowed portion configured to provide a line of sight into the cavity to confirm a placement of the ear within the cavity; and a drip catch configured to capture a portion of fluid used during an ear cleaning procedure that leaks from an ear canal of the subject; a first reservoir removably coupled to the support structure, the first reservoir configured to hold a first volume of the fluid prior to the ear cleaning procedure; and a second reservoir removably coupled to the support structure, the second reservoir configured to receive a second volume of the fluid used during the ear cleaning procedure via a channel defined in the support structure.
[0008] In some embodiments, an apparatus can include a support structure; a first reservoir removably coupled to the support structure, the first reservoir configured to hold a first volume of fluid for a cleaning procedure; a second reservoir removably coupled to the support structure, the second reservoir configured to receiving a second volume of fluid used during the cleaning procedure; a delivery element removably coupled to the support structure, the delivery element positionable within an ear canal of an ear during the cleaning procedure, the delivery element including: a first channel configured to deliver the first volume of fluid from the first reservoir to the ear canal; a nozzle in fluid communication with the first channel, the nozzle having at least three openings, each opening of the at least three openings being directed at a different angle relative to the other openings; a second channel configured to receive the second volume of fluid from the ear canal and to direct the second volume of fluid toward the second reservoir; and an opening in fluid communication with the second channel and configured to receive the second volume of fluid from the ear canal.
[0009] In some embodiments, a method can include pumping fluid from a first reservoir through a first channel of an earpiece to a delivery element disposed within an ear canal of a subject; delivering the fluid into the ear canal through at least three openings of the delivery element, each opening of the at least three openings being directed at a different angle relative to the other openings; and generating negative pressure in a second reservoir to draw at least a portion of the fluid from the ear canal through the delivery element and a second channel of the earpiece into the second reservoir.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The skilled artisan will understand that the drawings primarily are for illustrative purposes and are not intended to limit the scope of the inventive subject matter described herein. The drawings are not necessarily to scale; in some instances, various aspects of the inventive subject matter disclosed herein may be shown exaggerated or enlarged in the drawings to facilitate an understanding of different features. In the drawings, like reference characters generally refer to like features (e.g., functionally similar and/or structurally similar elements).
[0011] FIG. l is a schematic diagram depicting an ear cleaning or irrigation device, according to an embodiment.
[0012] FIG. 2 is a schematic diagram depicting an ear cleaning or irrigation device, according to an embodiment. [0013] FIG. 3 is a front view of an ear cleaning or irrigation device on a stand, according to an embodiment.
[0014] FIG. 4 is a perspective view of on earpiece of the ear cleaning or irrigation device, according to an embodiment.
[0015] FIG. 5A is a front view of an earpiece of an ear cleaning device engaging a head of a patient, according to an embodiment.
[0016] FIGS. 5B-5C depict views of ear cleaning device of FIG. 5 A.
[0017] FIGS. 6A-6B depict an ear pad, according to an embodiment.
[0018] FIGS. 7A-7D depict a long ear tip, according to an embodiment.
[0019] FIGS. 8A-8D depict a short ear tip, according to an embodiment.
[0020] FIGS. 9A-9D depict various ear tips engaging an ear canal, according to embodiments.
[0021] FIGS. 10A-10D depict various nozzles of an ear tip, according to embodiments.
[0022] FIGS. 11 A-l 1C depict a discharge reservoir, according to an embodiment.
DETAILED DESCRIPTION
[0023] Ear wax, also known as cerumen, naturally forms in the outer portion of a person’s auditory canal and serves to protect and lubricate the auditory canal. In some cases, ear wax may build up in the auditory canal to the point that the ear wax can impact a person’s hearing. Moreover, objects inserted into the auditory canal (e.g., cotton swabs, fingers) can push ear wax deeper into the auditory canal towards the ear drum, which can further negatively impact a person’s hearing.
[0024] To clean the auditory canal with reduced risk of harming a person’s hearing, physicians have developed ear cleaning techniques in which a mixture of saline, hydrogen peroxide, and/or water is used to irrigate the auditory canal and remove an excessive build-up of ear wax. In some cases, irrigating the auditory canal by way of such techniques may, however, require a visit to a physician and the use of devices that require multiple people to operate. In addition, such devices and techniques that are used to irrigate the auditory canal may result in used cleaning agent or cleaning fluid, usually carrying flushed ear wax, to exit the auditory canal and impact the patient. After a cleaning procedure, a physician or other individual needs to clean a surrounding area and/or components used to collect used cleaning agent or flushed ear wax. Accordingly, it can be desirable to have a system for cleaning an auditory canal that overcomes the aforementioned problems, which can be operable by a single user, to safely and effectively clean the auditory canal, e.g., by irrigation and removal of excessive ear wax.
[0025] Embodiments of the present disclosure are directed to an ear irrigation and cleaning device and system. The ear cleaning device and system can be operable by a single user to safely and effectively clean an auditory canal by irrigation and removal of excessive ear wax.
[0026] The ear of a user, patient, or subject includes an auricle and an auditory or ear canal (collectively, e.g., “outer ear”, “external ear”, etc.). The auricle is a visible portion of the ear residing on an outside of the user’s head. The ear canal includes a portion of the ear extending inwardly from the auricle towards an eardrum (“eardrum” or “tympanic membrane”) to connect the eardrum to the auricle. Ear wax can build up or accumulate along a surface of the auricle and/or the ear canal. Systems, devices, and methods described herein facilitate the removal and/or cleaning of ear wax from a subject’s ear.
[0027] FIG. 1 is a schematic diagram depicting an ear cleaning or irrigation device 100, according to an embodiment. As shown, the ear cleaning device 100 may include, for example, a delivery element or cannula 110, an inlet port 112, a discharge port 114, a fluid reservoir 120 (“fluid reservoir 120” or “cleaning agent reservoir 120” or “fluid cleaning agent reservoir 120” or “first reservoir 120”), a discharge reservoir 130 (“discharge collection reservoir 130” or “second reservoir 130”), a support element 103, an inlet path 116, and a discharge path 118.
[0028] The ear cleaning device 100 may be worn on or by a user (e.g., on a head of the user), by positioning the support element 103 adjacent to an auricle of the user and mounting delivery element 110 in ear canal EC, to clean the ear canal EC by irrigation and removal of excessive ear wax. In some implementations, the irrigation and removal of excessive ear wax may include, for example, delivering a fluid cleaning agent to ear canal EC from the fluid reservoir 120 via the inlet path 116 and the inlet port 112. The fluid can be delivered at a preset pressure and/or preset flow rate sufficient to dislodge excessive ear wax from surfaces located in the ear canal EC. In some implementations, the fluid can be pre-pressurized within the fluid reservoir 120 such that the fluid, when released from the fluid reservoir 120 (e.g., by a valve), is delivered under a preset pressure and/or preset flow rate. The irrigation and removal of excessive ear wax may further include removing applied fluid from ear canal EC by discharge of the applied fluid through discharge port 114. The discharged fluid may be received in discharge reservoir 130 for later disposal via discharge path 118. The applied fluid may include a mixture of applied cleaning fluid and dislodged and entrained excessive ear wax from the ear canal EC.
[0029] Various portions of ear cleaning device 100 may be anatomically sized to fit a user, such as with respect to an anatomical size of the auricle and/or ear canal EC, as shown in FIG. 1. For example, in some implementations, ear cleaning device 100 may include a delivery element (e.g. delivery element 110) having a longitudinally tapering or constant diameter, cross-section, or the like, to facilitate insertion and fit in ear canal EC. In some implementations, delivery element 110 may include, for example, a longitudinally tapering diameter having variation within a range of approximately 4 to 7 millimeters (mm). In some implementations, delivery element 110 may include a longitudinally tapering diameter having variation within a range suitable and compatible for use with an anatomical size of a user, patient, or subject. In some implementations, delivery element 110 may include a longitudinally tapering shape that gradually decreases in diameter from a proximal end (e.g., as in the end adjacent to the support element 103) to a distal end (e.g., as in the end disposable in ear canal EC). Delivery element 110 may otherwise include a longitudinally constant diameter. In some implementations, the delivery element may include curved portions configured to match the anatomical shape of the ear canal EC.
[0030] The delivery element 110 may include an inlet channel 112 and a discharge channel 114. In inlet channel 112 may be configured to deliver fluid to the ear canal EC from the fluid reservoir 120. The distal end of the inlet channel 112 includes a nozzle configured to direct fluid, e.g., into the ear canal EC. In some embodiments, the nozzle includes one or more apertures configured to deliver the fluid at different angles and/or with a predefined spray pattern. In some embodiments, the nozzle includes two streams that direct flow upward and one that directs flow downward. In some embodiments, the apertures of the nozzle can be sized to deliver the fluid at predetermined fluid flow rates. The discharge channel 114 includes an opening configured to receive and direct discharged fluid to the discharge reservoir 130. In some implementations, the delivery element 110 may be disposable and/or recyclable. For example, in some implementations, the delivery element 110 may include or may be made partially or entirely of disposable and/or recyclable plastic materials. The delivery element 110 can be sized for use by different patient populations, e.g., for use by an adult, a child, and/or other populations. In some embodiments, the delivery element 110 can have different configurations depending on the size of the ear canal EC. In some embodiments, the delivery element 110 can have different configurations for cleaning different portions of the ear canal EC. For example, the delivery element 110 can have a longer configuration configured to clean a deeper portion of the ear canal EC and shorter configuration configured to clean a shallower portion of the ear canal EC. In some embodiments, the delivery element 110 can have different size for accommodating different sized ears of a user, e.g., a first size for pediatric users vs. a second size for adult users. As described and shown in later figures herein, the delivery element 110 can have curvatures and/or angles along its longitudinal length toward the mandible that more closely track or follow the general shape of an ear canal EC, e.g., for better positioning within an ear canal and/or comfort during use. For example, the delivery element 110 can have a distal portion that is angled relative to a proximal portion by between about 10 degrees to about 45 degrees, including all ranges and values therebetween.
[0031] In some implementations, ear cleaning device 100 may optionally include an ear pad 122. The ear pad 122 may be positioned adjacent to a perimeter of delivery element 110 to support the ear cleaning device 100 on the head of the patient. For example, ear pad 122 may include an annular membrane concentrically arranged at or about the perimeter of delivery element 110. In some implementations, the annular membrane may be sized and shaped to resemble a portion of a solid torus (e.g., the top half of a doughnut). Such a curved or partially toroidal surface may be used to create a barrier about delivery element 110, so as to contain or catch communicated fluid to increase the user’s comfort when wearing the ear cleaning device 100. [0032] In some embodiments, the ear pad 122 includes a recessed portion. The recessed portion, when the ear cleaning device 100 is worn, can function as a window through which a user can confirm proper positioning of the delivery element 110 in the ear canal EC. This can be beneficial, for example, to a caregiver, healthcare professional, etc. who may be placing the device onto a patient. In some embodiments, the support element 103 (or other portion of the ear cleaning device) includes a light (e.g., LED light) that allows for better visualization of the delivery element 110 when the ear cleaning device 100 is being worn. For example, the light can light up a space near the delivery element 110 so that it is easier for a healthcare professional to see the delivery element 110 being placed into the ear canal EC. Alternatively, the ear cleaning device can include one or more sensors (e.g., pressure sensors) that can provide feedback for activating one or more lights to indicate when the delivery element 110 has been placed within the ear canal. The sensors can detect, for example, pressure against the delivery element 110 and/or air pressure changes in the ear canal as the delivery element 110 is being placed within the ear canal. In some embodiments, the ear pad 122 includes a fluid trap (e.g., a cut out area, opening, recessed portion, or other suitable structure) configured to collect fluid that may drip out of the ear canal EC during use. The fluid trap can be located in a section of the ear pad 122 under the delivery element 110. The sidewalls of the fluid trap can be configured to contain any fluid that drips out of the ear canal EC while the device is held upright. As such, a healthcare professional can finish a cleaning procedure and then remove the device while holding it upright to avoid leakage of any fluid that has been collected in the fluid trap. In some embodiments, the ear pad 122 can include a hollow interior, and a hole or opening can allow excess fluid that drips out of the ear canal EC during a cleaning procedure to drip through the hole and be collected in the hollow interior of the ear pad 122.
[0033] Inlet channel 112 may include, for example, one or more fluid delivery apertures or ports to enable and facilitate fluid communication from inlet channel 112 to ear canal EC for introducing and applying fluid (e.g., having cleaning agent) to ear canal EC under pressure. In some implementations, inlet channel 112 may be configured based on parameters relating to, for example, flow rate, flow type (e.g., laminar, turbulent, etc.), dimensions, shape, and the like. Inlet channel 112 may be connected to inlet path 116 by way of coupling 105 for fluid communication with fluid reservoir 120 by way of coupling 104. In some implementations, inlet channel 112 may be dimensioned for integration with or coupling to delivery element 110. For example, inlet channel 112 may be embedded in or coupled to delivery element 110. In general, inlet channel 112 may be fluidly connected to or otherwise formed as a part of delivery element 110 in any suitable manner to enable delivery and application of fluid to ear canal EC.
[0034] Discharge channel 114 may include, for example, one or more fluid discharge apertures or ports to enable and facilitate fluid communication from ear canal EC to discharge channel 114 for receiving and discharging applied fluid from ear canal EC (e.g., for disposal in discharge reservoir 130). In some implementations, discharge channel 114 may be configured based on parameters related to flow rate, flow type (e.g., laminar, turbulent, etc.), dimensions, shape, and the like. In some implementations, discharge channel 114 may include a valve, such as a non-retum valve, check-valve 1-way valve, or the like, such as to prevent recirculation of applied fluid in ear canal EC. The valve may be configured based on parameters related to cracking pressure, dimensions, shape, and the like. In some implementations, discharge channel 114 may be connected to discharge path 118 by way of coupling 105 for fluid communication with discharge reservoir 130 by way of coupling 104. Discharge channel 114 may be dimensioned for integration with or coupling to delivery element 110 such as in a manner similar to that described with reference to inlet channel 112. In general, discharge channel 114 may be fluidly connected to or otherwise formed as part of delivery element 110 in any suitable manner to enable receipt and discharge of applied fluid from ear canal EC.
[0035] Fluid reservoir 120 may be configured to contain a first volume of fluid such as a liquid, e.g., a liquid including a cleaning agent for irrigation and cleaning of a user’s auditory canal (e.g., ear canal EC). The cleaning agent can include, for example, an antimicrobial agent, an antifungal agent, an antibacterial agent, an acidic agent, an alkaline agent, a neutral agent, etc. In some embodiments, the liquid can include a buffer solution for maintaining a specific pH. In some implementations, the fluid cleaning agent may include, for example, water, a saline solution, and/or a hydrogen peroxide solution. The fluid reservoir 120 may connect to inlet path 116 by way of coupling 104, and inlet path 116 may connect to inlet channel 112 by way of coupling 105 to establish fluid communication therebetween. Fluid reservoir 120 may be or include, for example, a reservoir, container, or the like. In some implementations, the fluid reservoir 120 may be disposable or recyclable. In some implementations, the fluid may alternatively or additionally include, for example, an antibacterial agent, an antibiotic agent, or the like.
[0036] In some implementations, fluid reservoir 120 may be configured to heat a contained supply of fluid cleaning agent to, for example, a temperature range having limits substantially equal to, above, and/or below body temperature (e.g., of a user), such as to support a comfort level of the user during use of the irrigation device 100. In such implementations, the fluid reservoir 120 may include, for example, a heating component such as a heater or resistive element configured to heat and maintain the contained supply of fluid at a predefined (e.g., user-selected) temperature. In such implementations, the fluid reservoir 120 may be insulated. In such implementations, the fluid reservoir 120 may include a temperature sensor such as a thermometer for measuring the temperature of a contained supply of fluid. In some implementations, the cleaning agent reservoir 120 may be filled with a supply of cleaning agent at approximately body temperature. For example, in some implementations, the fluid reservoir 120 may be pre-filled (e.g., come pre-packaged with a supply of a fluid cleaning agent). In other implementations, a user or someone (e.g., a physician or other medical practitioner) administering the fluid cleaning agent can prepare and/or fill the fluid reservoir 120 with a supply of fluid cleaning agent. In some embodiments, the fluid reservoir 120 is configured to store sufficient fluid for performing at least one, at least two, at least three, at least four, at least five, at least about 10, at least about 20, or at least about 50 cleaning cycles, including all ranges and values therebetween. In some embodiments, the fluid reservoir 120 is configured to store about 50mL to about 150 mL, including all ranges and values therebetween. In some embodiments, the fluid reservoir 120 is configured to store about 140mL of fluid. In some embodiments, the fluid reservoir 120 includes an inlet configured to accept fluid, e.g., for filing the fluid reservoir before use. In some embodiments, the fluid reservoir may have an angled bottom surface (e.g., a ramp), e.g., for directing fluid toward a drain hole that connects to the inlet path 116 and inlet channel 112. This can be beneficial for patients (e.g., elderly, children) who may not be able to sit upright for extended periods of time, as the angled surface can direct the fluid toward the drainage hole. [0037] The discharge reservoir 130 may connect to a discharge path 118 by way of a coupling 104, and the discharge path 118 may connect to a discharge channel 114 by way of a coupling 105, to establish fluid communication therebetween. The discharge reservoir 130 may include, for example, a container or reservoir for receiving and containing applied liquid or a second volume of fluid from a user’s auditory canal (e.g., for later disposal). For example, the fluid received by and contained in the discharge reservoir 130 may include a mixture of applied fluid having dislodged and entrained excessive ear wax from ear canal EC. In some implementations, the discharge reservoir 130 may be disposable and/or recyclable. For example, in some implementations, the discharge reservoir 130 may be made of disposable and/or recyclable plastic materials. In some implementations, the fluid reservoir 120 and/or the discharge reservoir 130 may be enclosed within one or more containers configured for removable attachment to the support element 103, as shown in FIG. 1. In some embodiments, the discharge reservoir 120b is configured to store the same volume of fluid as the fluid reservoir 120a (or a portion thereof). In some embodiments, the discharge reservoir 120b is larger than the fluid reservoir 120a, e.g., to accommodate for capture of ear wax or other debris from the ear canal EC.
[0038] In some implementations, the support element 103 may include a controller 150, an input/output (VO) or user interface 160 (“I/O interface 160” or “user interface 160”), an inlet path 116, and a discharge path 118.
[0039] The support element 103 may be configured, sized, and shaped to fit on, over, or about an ear of a user at a position adjacent to auricle to facilitate mounting of delivery element 110 in ear canal EC, and further, to facilitate establishing and maintaining fluid communication between fluid reservoir 120 and inlet channel 112 as well as between discharge reservoir 130 and discharge channel 114, respectively. For example, in some implementations, inlet path 116 may be connected at a proximal end to fluid reservoir 120 by way of a first fluid coupling (e.g. coupling 104), and at a distal end to inlet channel 112 by way of a second fluid coupling (e.g. coupling 105), as shown in FIG. 1. Similarly, discharge path 118 may be connected at a proximal end to discharge reservoir 130 by way of a third fluid coupling (e.g. of coupling 104), and at a distal end to inlet channel 112 by way of a fourth fluid coupling (e.g. of coupling 105), as shown in FIG. 1. [0040] Each coupling 104 and 105 may include one or more suitable fluid interfaces, adaptors, fittings, couplings, and the like. Coupling 104 may include the first and third fluid couplings and coupling 105 may include the second and fourth fluid couplings. In some implementations, couplings 104 and/or 105 may include peripheral components for confirming connections, such as between one or more of inlet channel 112, inlet path 116, and/or fluid reservoir 120, as well as between discharge channel 114, discharge path 118, and/or discharge reservoir 130. For example, couplings 104 and/or 105 may include components that generate an auditory signal (e.g., a “click” noise), a haptic signal, a visual signal, and/or otherwise indicate proper coupling between the different components of the ear cleaning device 100.
[0041] The controller 150 may be configured to provide control to a user over the operations of the ear cleaning device 100. The controller 150 may include any suitable type of controller or processor. The controller 150 may be connected to the I/O interface 160 for data communications. In some implementations, the controller 150 and the I/O interface 160 may be coupled for data communications. For example, the controller 150 may be configured to send, receive, transmit or otherwise communicate data (e.g., user input data, operational status data, etc.) to and from VO interface 160. The data communications between the controller 150 and the I/O interface 160 may be transmitted via wired, wireless, or fiber optic connections. For example, the controller 150 may include control circuitry (not depicted) for communicating and/or executing machine-executable program instructions (e.g., as may be stored on machine-readable storage media). In the example, the controller 150 may execute a set of machine-executable instructions corresponding to an ear cleaning operation or procedure, such as may be stored on machine-readable storage media, upon command by a user. The ear cleaning device 100 may be controlled (e.g., by a user) by way of the controller 150 and the VO interface 160 with respect to a target treatment volume or area, such as the space or surface in, about, or along ear canal EC and/or auricle AR.
[0042] The I/O interface 160 may be configured to receive user inputs and commands from a user. In some implementations, the I/O interface 160 may include, for example, a button, switch, touch screen, and/or any other suitable actuation mechanism to receive the user inputs and commands. The VO interface 160 may additionally or alternatively include, for example, a display or screen (not depicted) for displaying feedback such as device or operational status to the user, such as with respect to irrigation operation to be performed, and the like. The I/O interface 160 may be electrically and communicatively coupled to the controller 150 for data communications. The data communications may include, for example, user inputs received by the I/O interface 160 from the user, which may be communicated or sent to the controller 150 for execution in performing a user-selected ear cleaning operation. The user inputs may include, for example, selections of one or more of a plurality of irrigation programs (e.g., respectively stored as sets of processor-executable instructions on one or more memories).
[0043] In some implementations, the I/O interface 160 may include a touchscreen device. The touchscreen device may be configured to, for example, receive user inputs from and provide feedback to the user such as by way of a display to facilitate user selection, adjustment, and configuration of irrigation operations to be performed by the ear cleaning device 100. In some implementations, the touchscreen device of the I/O interface 160 may be configured to render and display one or more graphical user interface symbols or elements resembling one or more corresponding user interface elements, such as buttons, scales, bars, panels, switches, or any other user interface element corresponding to a control signal or user-selectable input or command.
[0044] With continued reference to FIG. 1, in some implementations, the ear cleaning device 100 may include a power supply 170, a pump assembly 124, and a vacuum assembly 126.
[0045] The power supply 170 may be configured to store and supply power to various powerconsuming components of the ear cleaning device 100, such as the controller 150, the I/O interface 160, the pump assembly 124, and/or the vacuum assembly 126. In some implementations, for example, the power supply 170 may include a portable power source such as a battery, or the like, having a power storage capacity sufficient to supply power to the power-consuming components of the ear cleaning device 100 for performance of an irrigation operation. In some embodiments, the ear cleaning device 100 can be configured for induction charging, e.g., to allow for charging / re-charging of the onboard power supply 170.
[0046] In some implementations, for example, the pump assembly 124 may include any suitable pneumatic, hydraulic, or mechanical pump configured to move fluid from the fluid reservoir 120 to the ear canal EC under pressure (e.g. at a positive pressure greater than one atmosphere, or ambient pressure). The pump assembly 124 may be configured to couple to fluid reservoir 120, inlet path 116, and inlet channel 112 to move a supply of fluid from the fluid reservoir 120 to the ear canal EC under a preset pressure and/or at a preset flow rate. For example, the pump assembly 124 may include a positive displacement pump such as a peristaltic pump, a diaphragm pump, or the like. In some implementations, the pump assembly 124 may be configured to move the supply of fluid in conjunction with one or more peripheral devices such as pressure storage reservoir (e.g., a hydraulic accumulator), flowcontrol valves, an energy storage device such as an internal, elastic diaphragm positioned in the fluid reservoir 120, and the like.
[0047] The vacuum assembly 126 may include, for example, a vacuum or suction pump (e.g., a scroll pump) or any other suitable type of pump for generating and applying a vacuum or suction (e.g., at negative pressure less than one atmosphere or ambient pressure), such as with respect to the discharge reservoir 130, to draw fluid from the ear canal EC. Vacuum assembly 126 may couple to discharge reservoir 130, discharge path 118, and discharge channel 114 to apply the vacuum to ear canal EC for discharge and receipt of previously applied fluid, having dislodged and entrained excessive ear wax from ear canal EC. In some implementations, ear cleaning device 100 does not include a vacuum assembly 126, and in such implementations, fluid may drain from the ear, e.g., due to a pressure differential between the ear canal EC and one or more of the discharge channels 114, discharge path 118, and discharge reservoir 130. Such a pressure differential can result from the delivery of pressurized fluid into the ear canal EC and/or due to a pre-set vacuum within discharge reservoir 130. In some implementations, while ear cleaning device 100 does not include a vacuum assembly 126, ear cleaning device 100 can be coupled to a vacuum that can draw fluid out from the ear via discharge channel 114 and/or another fluid path (not depicted). For example, a vacuum can be coupled to discharge reservoir 130 to generate a vacuum for withdrawing fluid from the ear canal EC.
[0048] As an example, in some implementations, a device (e.g., ear cleaning device 100) to irrigate ear canal(s) of human ear(s) (e.g., auricle and ear canal EC) may include a first overear earpiece (e.g., support element 103) sized and dimensioned to be worn over human ears and having a cavity sized and dimensioned to receive one human ear. The device (e.g., ear cleaning device 100) may include a first cleaning agent reservoir (e.g., fluid reservoir 120) to hold cleaning agents, and a first discharge collection reservoir (e.g., discharge reservoir 130) to collect and hold discharge from irrigation. The device (e.g., the ear cleaning device 100) may further include a first cleaning interface (e.g., delivery element 110) to which one or more cleaning agent delivery elements are selectively, detachably, and physically couplable. The device (e.g., the ear cleaning device 100) may further include a first fluid communication path (e.g., extending between fluid reservoir 120 and inlet channel 112 across inlet path 116) that provides fluid communication for the cleaning agent between the first cleaning agent reservoir and the first cleaning interface, and a second fluid communication path (e.g., extending between discharge reservoir 130 and discharge channel 114 across discharge path 118) that provides fluid communication for communication of the discharge between the first discharge collection reservoir and the first cleaning interface. The device (e.g., ear cleaning device 100) may be implemented by a user (e.g., via I/O interface 160) to perform (e.g., via controller 150) an ear cleaning operation or procedure to clean the auricle and the ear canal EC by irrigation and removal of excessive ear wax.
[0049] FIG. 2 is a schematic diagram depicting an ear cleaning or irrigation device 200, according to an embodiment. As shown, the ear cleaning device 200 may include, for example, first and second earsets or over-ear earpieces 201a and 201b (collectively, “earset(s) 201” or “over-ear earpiece(s) 201”), connected to one another by a support element 203. Further, the over-ear earpieces 201a and 201b may respectively include first and second delivery elements 210a and 210b (collectively, “delivery element(s) 210”), configured for respective insertion and mounting in first and second ear canals EC, first and second fluid reservoirs 220a and 220b (collectively, “fluid reservoir(s) 220” or “cleaning agent reservoir(s) 220” or “fluid cleaning agent reservoir(s) 220”), and first and second discharge reservoirs 230a and 230b (collectively, “discharge reservoir(s) 230”). In some implementations, the over-ear earpieces 201 and/or the support element 203 may be similar in structure, form, and/or function to that of the ear cleaning device 100 and the support element 103, as described with reference to FIG. 1.
[0050] The earsets 201 represent, for example, individual ear cleaning devices such as that described with reference to FIG. 1. In some implementations, the earsets 201 may be operably connected to one another by the support element 203, as shown in FIG. 2, and may be configured for concurrent or individual use in cleaning ear canals EC - simultaneously or one at a time - by irrigation and removal of excessive ear wax. For example, as shown in FIG. 2, the ear cleaning device 200 may be worn on or by a user by positioning the support element 203 atop head HD and adjacent auricles, and mounting delivery elements 210 in the ear canals EC, to clean the ear canals EC simultaneously or one at a time by irrigation and removal of excessive ear wax therefrom.
[0051] The earsets 201 may be similar in structure, form, and/or function. In some implementations, for example, the first earset 201a may include delivery element 210a, fluid reservoir 220a, and discharge reservoir 230a, and the second earset 201b may include delivery element 210b, and in some optional instances, fluid reservoir 220b, and discharge reservoir 230b. The fluid reservoirs 220, the discharge reservoirs 230, and the delivery elements 210 may be analogous (e.g., as in structure, form, or function) to the fluid reservoir 120, the discharge reservoir 130, and the delivery element 110, as described with reference to FIG. 1. Further, while not depicted, in some implementations the earsets 201 may respectively include one or more of the components described with reference to the ear cleaning device 100, including, for example, the ear pad 122, the controller 150, the VO interface 160, the power supply 170, the pump assembly 124, and/or the vacuum assembly 126. The earsets 201 may each respectively include a vertical axis (not depicted) oriented substantially perpendicular to the ground when a user wearing ear cleaning device 200 is in an upright position, and a horizontal or lateral axis oriented substantially parallel to the ground when the user wearing ear cleaning device 200 is in the upright position. While discussed with respect to an upright position for ease of reference, it should be noted that a user does not necessarily need to be in an upright position during use of ear cleaning device 200.
[0052] In some implementations, the earsets 201 may be operably connected to one another, for example, by way of respective fluid couplings and one or more fluid communication paths 211. As shown in FIG. 2, in some implementations, the one or more fluid communication paths 211 may be configured to enable fluid communication between the delivery element 210b and the fluid reservoir 220a as well as the discharge reservoir 230a. In such implementations, the first fluid reservoir 220a may include a fluid capacity sufficient to contain a supply of fluid for performing an irrigation operation (e.g., at least 70 milliliters), in which the fluid is delivered into both the first and second ear canals EC of a user via respective delivery elements 210a and 210b. Further, in such implementations, the first discharge reservoir 230a may include a fluid capacity equal to or greater than that of the fluid reservoir 220a, to contain applied fluid removed from both the first and second ear canals EC of the user via the respective delivery elements 210a and 210b during the irrigation operation. In other implementations, the delivery element 210b may additionally or alternatively be configured for fluid communication with the fluid reservoir 220b and the discharge reservoir 230b. For example, the one or more fluid communication paths 211 may be configured to alternatively or additionally enable fluid communication between the delivery element 210b and the fluid reservoir 220b as well as the discharge reservoir 230b.
[0053] In some implementations, the irrigation of and removal of excessive ear wax from the first ear canal EC may include, for example, delivering fluid under pressure from the first fluid reservoir 220a to the first ear canal EC by way of the first delivery element 210a, as shown in FIG. 2. In such implementations, the irrigation of and removal of excessive ear wax from the first ear canal EC may further include, for example, removing, by way of the first delivery element 210a, the delivered and applied fluid from the first ear canal EC for disposal in the discharge reservoir 230a. In some implementations, the irrigation and removal of excessive ear wax from the second ear canal EC may include, for example, delivering fluid under pressure from the first and/or second fluid reservoirs 220a and 220b to the second ear canal EC by way of the second delivery element 210b. In such implementations, the irrigation of and removal of excessive ear wax from the second ear canal EC may further include, for example, removing, by way of the second delivery element 210b, the delivered and applied fluid from the second ear canal EC for disposal in the first and/or second discharge reservoirs 230a and 230b.
[0054] Various portions of ear cleaning device 200 may be anatomically sized to fit various users, such as with respect to various anatomical sizes of and/or spatial relations between head HD, and/or ear canal EC, as shown in FIG. 2. In some implementations, the support element 203 may include, for example, an adjustable (e.g., deformable or flexible) head strap, one or more vertical adjustors (not depicted), and one or more pivot couplers (not depicted) to enable and facilitate adjustment and variation of the relative spatial positions of the first and second earsets 201 by a user. The adjustment and variation of the relative spatial positions of the first and second earsets 201 may include, for example, lateral or horizontal displacement of the first or second earsets 201 with respect to a lateral axis extending between points on the first and second earsets 201, vertical displacement of the first or second earsets 201 with respect to a vertically-oriented axis, and the like. Accordingly, the ear cleaning device 200 may be configured to accommodate various head shapes and sizes of various users (e.g., various circumferential distances between the ears of the various users) by enabling selective spatial positioning and fitting adjustment of the first and second earsets 201.
[0055] In some implementations, the one or more pivot couplers with which each earset 201 may individually and respectively couple or connect may be configured to enable and facilitate independent rotational displacement (“rotational displacement” or “rotational motion” or “pivoting motion” or “pivotal motion”) of each earset 201 about respective, spaced-apart axes. Accordingly, the pivot couplers may be configured to enable and facilitate more comfortable and individualized fit of the earsets 201 on various users, by accommodation of the unique contours and shapes of individual user’s heads.
[0056] In some implementations, the first and second earsets 201a-b may include respective annular brackets (not depicted). Each annular bracket may be individually sized and shaped to be slightly larger than a portion of a perimeter of a respectively associated earset (e.g., the first earset 201a or the second earset 201b). As an example, in some implementations, a first annular bracket may be sized and shaped to run along the top half of the perimeter of a respectively associated earset including the first earset 201a, and a second annular bracket may be sized and shaped to run along the top half of the perimeter of a respectively associated earset including the second earset 201b. Each annular bracket may be pivotally coupled to support element 203 at and by way of a junction, interface, or physical coupling, to enable and facilitate independent, rotational motion of the first and second earsets 201a-b.
[0057] FIG. 3 is a front view of an ear cleaning device 300, according to an embodiment. The ear cleaning device 300 is depicted on a stand in FIG. 3, though it can be appreciated that in use the ear cleaning device 300 would be positioned over a head of a patient. In some embodiments, the ear cleaning device 300 is functionally and/or structurally similar to the ear cleaning device 100 of FIG. 1 and/or the ear cleaning device 200 of FIG. 2. As shown, the ear cleaning device 300 may include a first and second over-ear earpieces or earsets 301a and 301b (collectively, “over-ear earpiece(s) 301 or “earset(s) 301”) (e.g., functionally and/or structurally similar to the earsets 201 and 201b of FIG. 2), a support element 303 (e.g., structurally and/or functionally similar to the support element 103 of FIG. 1 and/or the support element 203 of FIG. 2), a first and second delivery element 310a and 310b (collectively, “delivery element(s) 310) (e.g., structurally and/or functionally similar to the delivery element 110 of FIG. 1 and/or the delivery elements 210 of FIG. 2), a first and second fluid reservoir 320a and 320b (collectively, “fluid reservoir(s) 320) (e.g., functionally and/or structurally similar to the fluid reservoir 120 of FIG. 1 and/or the fluid reservoir(s) 220 of FIG. 2), a first and second discharge reservoir 330a and 330b (collectively, “discharge reservoir(s) 330) (e.g., functionally and/or structurally similar to the discharge reservoir 130 of FIG. 1 and/or the discharge reservoir 230 of FIG. 2), and a first and second ear pad 322a and 322b (collectively, “ear pad(s) 322)) (e.g., functionally and/or structurally similar to the ear pad 122 of FIG. 1. In some embodiments, the fluid reservoir(s) 320 and the discharge reservoir(s) 330 from fluid containers.
[0058] In some implementations, the ear cleaning device 300 may be sized and shaped such that the first over-ear earpiece 301a fits over a user’s right ear, and the second over-ear earpiece 301b fits over the user’s left ear. In some implementations, the ear cleaning device 300 may be sized and shaped such that the first over-ear earpiece 301a fits over a user’s right or left ear, and the second over-ear earpiece 301b fits over the user’s left or right ear. For example, each over-ear earpiece 301 may be sized and shaped for interchangeable fit over either of a user’s right and left ears. In some embodiments, the ear cleaning device 300 is worn on the head of the user such that the support element 303 curves around the top of the head of a user. In some embodiments, the ear cleaning device 300 may be worn while a user is standing, seated, reclining, or laying down. In the embodiment of FIG. 3, the second earpiece 301b includes an input/output interface 360 (e.g., functionally and/or structurally similar to the input/output interface 160 of FIG. 1). The input/output interface 360 can include an input button that a user can user to power on, power off, and/or operate the ear cleaning device 300. In some embodiments, the input/output interface 360 is operatively coupled to a controller such as the controller 150 of FIG. 1. In some embodiments, the input/output interface 360 can include a device (e.g., light, speaker, etc.) configured to communicate information (e.g., status, battery life, operating condition, etc.) to the user.
[0059] The containers including the fluid reservoirs 320 and the discharge reservoirs 330 are coupled to the earsets 301 via a first and second coupling 304a and 304b (collectively, “coupling(s) 304”) (e.g., structurally and/or functionally similar to the coupling 104 of FIG. 1). The coupling(s) 304 can be a clip, a pin, press fit, and/or the like. The coupling(s) 304 is configured to support the weight of the containers and the fluid within the fluid reservoir(s) 320 and the discharge reservoir(s) 330. The containers and the earsets 301 can form a seal so that any fluid stored in the fluid reservoir(s) 320 and the discharge reservoir(s) 330 does not leak out. In some embodiments, a single unitary container can be used, with the fluid reservoir(s) 320 and the discharge reservoir(s) 330 defined by different portions of the container.
[0060] As seen in FIG. 4, the containers can be radially larger than the earset 301b. This can facilitate gripping and/or holding of the device while putting it on or taking it off of a user. In some embodiments, the containers can store sufficient fluid for multiple cleaning cycles (e.g., at least about 2, at least about 3, at least about 4, at least about 5, at least about 10, etc.). The fluid reservoir(s) 320 can include a fluid inlet 324 which can be used to fill the fluid reservoir(s) 320 with fluid. The fluid inlet 324 can be a one-way valve that only allows fluid to be filled into the fluid reservoir(s) 320 and prevents fluid from leaving or leaking out of the fluid reservoir(s) 320. The discharge reservoir(s) 330 can include an outlet 332 configured to allow fluid and/or debris to be drained out of the discharge reservoir(s) 330. In some embodiments, the outlet 332 can include a plug so that fluid and/or debris only leaves the discharge reservoir(s) 330 when the plug is removed.
[0061] FIG. 5A is a front view of an ear cleaning device 500 engaging a head HD of a patient, according to an embodiment. The ear cleaning device 500 can be functionally and/or structurally similar to the ear cleaning device 100 of FIG. 1, the ear cleaning device 200 of FIG. 2, and/or the ear cleaning device 300 of FIGS. 3A-3B. The earpiece 501 of the ear cleaning device 500 is structurally and/or functionally similar to any of the earpieces described herein, such as the earpieces 201 of FIG. 2 and/or the earpieces 301 of FIGS. 3A- 3B. The ear cleaning device 500 includes a support element 503 (e.g., structurally and/or functionally similar to the support element 103 of FIG. 1, the support element 203 of FIG. 2, and/or the support element 303 of FIG. 3), a fluid reservoir 520 (e.g., structurally and/or functionally similar to the fluid container 120 of FIG. 1, the fluid reservoir(s) 220 of FIG. 2, and/or the fluid reservoirs(s) 320 of FIGS. 3A-3B), a discharge reservoir 520 (e.g., structurally and/or functionally similar to the discharge container 120 of FIG. 1, the discharge reservoir(s) 220 of FIG. 2, and/or the discharge reservoirs(s) 320 of FIGS. 3A-3B), an ear pad 522 (e.g., functionally and/or structurally similar to the ear pad 122 of FIG. 1, the ear pad(s) 222 of FIG. 2, and/or the ear pad(s) 322 of FIGS. 3A-3B), and a delivery element 510 (e.g., structurally and/or functionally similar to the delivery element 110 of FIG. 1, the delivery element(s) 210 of FIG. 2, and/or the delivery element(s) 310 of FIGS. 3A-3B.
[0062] The earpiece 501 is worn by the patient such that the delivery element 510 engages an auricle and ear canal of the patient’s head HD. The ear pad 522 presses against the head HD, providing the patient with a soft cushion and controls the depth that the delivery element 510 enters into the ear canal. The ear pad 522 defines a cavity or space for receiving the ear. The ear pad 522 can have a recessed or windowed portion 522a. The windowed portion 522a allows for a user (e.g., healthcare professional) to see the delivery element 510 being inserted into the ear canal. This allows for the user to properly position the delivery element 510 and to observe the delivery element 510 during operation. In some embodiments, the earpiece 501 includes a light source configured to illuminate the space visible through the windowed portion 522a. As seen in FIG. 6A, the ear pad 522 can include two windowed portions 522a, e.g., for viewing from either side of the device. In some embodiments, the ear pad 522 can include one windowed portion 522a, e.g., for viewing from a front side of the device. In some embodiments, the windowed portion 522a can be a cutout or recess in the ear pad 522 that provides a line of sight into the cavity or space for receiving the ear of the patient. The line of sight can allow the user to confirm whether the delivery element 510 has been placed within the ear canal of the patient. In some embodiments, the windowed portion 522a can include a translucent or transparent portion of the ear pad 522.
[0063] While a recessed or windowed portion is described with reference to the ear cleaning device 500, it can be appreciated that other mechanisms can be used to provide visualization to a user while they are placing the ear cleaning device on a patient. For example, instead of or in addition to having the windowed portion, the ear pads 522 of the ear cleaning device 500 can be made from a transparent or translucent material.
[0064] In some embodiments, the ear pad 522 is configured to prevent the delivery element 510 from entering into the ear canal past a predetermined depth. As seen in FIG. 6B, the ear pad 522 defines a first width 522c and a second width 522d. In some embodiments, as seen in FIG. 6B, the second width 522d is greater than the first width 522c as to accommodate the shape of the head HD. In some embodiments, the length of the windowed portion 522a is about 10% to about 40% of an outer perimeter of the ear pad 522.
[0065] FIGS. 5B-5C depict different views of ear cleaning device 500 of FIG. 5A. As shown in the views, the ear pads 522 include a drip catch or trap 522b. The drip catch 522b is an area of the lower section of the ear pad 522 directly under the delivery element 510. When the device is worn, the drip catch 522b can be located at an inferior side of the ear pad 522. In particular, the drip catch 522b can be located below the ear canal such that fluids that escape or leak out of the ear canal can be captured by the drip catch. During operation of the ear cleaning device, the drip catch 522b can catch fluid that may drip out of the ear canal. As seen in FIG. 5 A, the drip catch can extend in the ear pad 522 from one windowed portion 522a to the other windowed portion 522a. In some embodiments, the drip catch 522b can include a drain or an outlet configured to drain fluid from the drip catch 522b, e.g., into the ear pad 522 or through the device and into a discharge reservoir or other reservoir.
[0066] FIGS. 7A-7D and 8A-8D depict different configurations of delivery elements or ear tips of ear cleaning devices, according to embodiments. FIGS. 7A-7D depict a long ear tip 710, according to an embodiment. In some embodiments, the long ear tip 710 is structurally and/or functionally similar to the delivery elements described herein, such as the delivery element 110 of FIG. 1, the delivery elements 210 of FIG. 2, the delivery elements 310 of FIG. 3, and/or the delivery elements 510 of FIGS. 5A-5C. The long ear tip 710 is configured to be inserted into an ear canal at or slightly past the isthmus of the ear canal and is intended to remove earwax that is more medial (e.g., deeper) in the ear canal. The long ear tip 710 can come in different sizes, e.g., to accommodate different sized ear canals. For example, there can be a regular configuration for regular to large diameter ear canals and a small configuration for small diameter ear canals. In some embodiments, the long ear tip 710 is disposable and/or recyclable. In some embodiments, the long ear tip 710 is flexible or deformable and can be configured to deform to the shape of an ear canal.
[0067] FIG. 7A depicts a perspective view of the long ear tip 710. The long ear tip 710 includes a body 710a, a tab or clip 710b, an inlet channel 712 (e.g., structurally and/or functionally similar to the inlet channel 112 of FIG. 1), and a discharge channel 714 (e.g., structurally and/or functionally similar to the discharge channel 114 of FIG. 1). The body 710a is configured to engage an earset, such as the earsets 201 of FIG. 2, the earsets 301 of FIGS. 3A-3B, and/or the earsets 501 of FIGS. 5A-5B. The clip 701b allows for the body 710a to be removed from engagement with an earset. For example, the clip 701b can allow for replacement, maintenance, cleaning, and/or the like. The clip 710b is angled away from the proximal end of the long ear tip 710 so that a user can grab the clip 710b to remove the long ear tip 710. The ear tip 710 can also include tabs or ridges at its proximal end for engaging with and coupling to a ridge or similar structure on an earset.
[0068] The inlet channel 712 is configured to receive fluid from a fluid reservoir, such as any one of the fluid reservoirs described herein, and direct the fluid into the ear canal. As seen in FIG. 7D, the inlet channel 712 includes an opening at the proximal end of the long ear tip 710 for receiving the fluid and directs the fluid to the distal end, as seen in FIG. 7C. At the distal end of the inlet channel 712 is a nozzle 712a. The nozzle 712a includes three openings configured to direct fluid in different directions. In some embodiments, the nozzle 712a can include any number of openings in any configuration (e.g., location, size, etc.) based on the intended use of the long ear tip 710. For example, the nozzle 712a can include between about 2 and about 10 openings, including all ranges and values therebetween. The discharge channel 714 is configured to receive discharged fluid through an opening 714a from the ear canal and direct the discharged fluid to a discharge reservoir, such as any one of the discharge reservoirs described herein. As seen in FIG. 7D, the discharge channel 714 includes an opening at the proximal end of the long ear tip 710 for directing fluid from the opening 714a through the discharge channel 714 to the discharge reservoir. In some embodiments, the discharge channel opening 714 may be circular. In some embodiments, the opening 714 may be an ellipse. In some embodiments, the diameter, or the major axis of the opening 714 may be about 3 mm to about 5 mm.
[0069] As seen in FIG. 7B, the outer body of the ear tip 710 can be curved such that a proximal end of the ear tip 710 is set at an angle Al relative to the distal end of the ear tip 710. As such, both the inlet channel 712 and the discharge channel 714 can be curved according to the angle Al. As depicted, the angle Al is defined as the angle between a central longitudinal axis of the proximal end of the long ear tip 710 and a central longitudinal axis of the distal end of the long ear tip 710. The angle Al can be between about 10 and about 50 degrees, including all ranges and values therebetween. In an embodiment, the angle Al can be at least about 10 degrees. The angle Al can be selected to generally conform to the anatomical shape of an ear canal of a patient population (e.g., an adult male population, an adult female population, a pediatric population, etc.). The inlet channel 712 and the discharge channel 714 can have a gradual curve from the distal end to the proximal end of the long ear tip 710. Alternatively, in some embodiments, the inlet channel 712 and the discharge channel 714 can be angled linearly, e.g., from a proximal end to a distal end of the ear tip 710 (or portions thereof). The curvature of the long ear tip 701 can correspond to or substantially match the curvature of the ear canal, e.g., for being able to reach deeper into the ear canal to clean those regions. In some embodiments, the curve of the body of the ear tip may be customized to the anatomical shape of the ear canal of a patient. The body of the ear tip 710 can also be tapered, e.g., from a proximal end to a distal end, to substantially correspond to or match the shape of a standard ear canal.
[0070] As depicted in FIGS. 7 A and 7B, the inlet channel 712 terminates at the nozzle 712a, which is extends more distally than the discharge channel 714. As such, when the ear tip 710 is placed within an ear, the nozzle 712a can be disposed deeper into the ear canal than the discharge channel 714. This can be beneficial to ensure that fluid exiting the nozzle 712a is delivered into the ear canal, e.g., for contacting and dislodging or breaking ear wax, before it is captured and discharged through the discharge channel 714. The smaller diameter of the nozzle openings 712a can also increase a fluid flow rate out of the nozzle 712a such that the exiting fluid is jetted into the ear canal to dislodge or break ear wax. The multiple openings of the nozzle 712a, as described in FIGS. 10A-10D, can facilitate an even distribution of fluid delivery and more effective cleaning of the ear canal.
[0071] FIGS. 8A-8D depict a short ear tip 810, according to an embodiment. In some embodiments, the short ear tip 810 is structurally and/or functionally similar to the delivery elements described herein, such as the delivery element 110 of FIG. 1, the delivery elements 210 of FIG. 2, the delivery elements 310 of FIG. 3, the delivery elements 510 of FIGS. 5A- 5C, and/or the ear tip 710 of FIG. 7A-7D. The short ear tip 810 is configured to be inserted into an ear canal at or slightly past the aperture of the ear canal and is intended to remove earwax that is more lateral (e.g., shallower) in the ear canal. In other words, the short ear tip 810 is shorter than the long ear tip 710 to allow the short ear tip 810 to remove earwax from a more lateral portion of the ear canal than the long ear tip 710. In some embodiments, the short ear tip 810 can include a regular configuration for regular to large diameter ear canals and a small configuration for small diameter ear canals. In some embodiments, the short ear tip 810 is disposable and/or recyclable. In some embodiments, the long ear tip 810 is configured to deform to the shape of an ear canal.
[0072] FIG. 8 A depicts a perspective view of the short ear tip 810. The short ear tip 810 includes a body 810a, a clip or tab 810b (e.g., structurally and/or functionally similar to the clip 710b), an inlet channel 812 (e.g., structurally and/or functionally similar to the inlet channel 112 of FIG. 1), and a discharge channel 814 (e.g., structurally and/or functionally similar to the discharge channel 114 of FIG. 1). The body 810a is configured to engage an earset, such as the earsets 201 of FIG. 2, the earsets 301 of FIGS. 3A-3B, and/or the earsets 501 of FIGS. 5A-5B. The clip 801b allows for the body 810a to be removed from engagement with an earset. The ear tip 810 can also include tabs or ridges at its proximal end for engaging with and coupling to a ridge or similar structure on an earset.
[0073] The inlet channel 812 is configured to receive fluid from a fluid reservoir, such as any one of the fluid reservoirs described herein, and direct the fluid into the ear canal. As seen in FIG. 8D, the inlet channel 812 includes an opening at the proximal end of the short ear tip 810 for receiving the fluid and directs the fluid to the distal end, as seen in FIG. 8C. At the distal end of the inlet channel 812 is a nozzle 812a. The nozzle 812a includes three openings configured to direct fluid in different directions. In some embodiments, the nozzle 812a can include any number of openings in any configuration (e.g., location, size, etc.) based on the intended use of the short ear tip 810. For example, the nozzle 812a can include between about 2 and about 10 openings, including all ranges and values therebetween. The discharge channel 814 is configured to receive discharged fluid through an opening 814a from the ear canal and direct the discharged fluid to a discharge reservoir, such as any one of the discharge reservoirs described herein. As seen in FIG. 8D, the discharge channel 814 includes an opening at the proximal end of the long ear tip 810 for directing fluid from the opening 814a through the discharge channel 814 to the discharge reservoir. In some embodiments, the discharge channel opening 814 may be circular. In some embodiments, the opening 814 may be an ellipse. In some embodiments, the diameter, or the major axis of the opening 814 may be about 3 mm to about 5 mm. [0074] As seen in FIG. 8B, the body of the ear tip 810 can be angled or curved. Given the shorter length of the ear tip 810 compared to the ear tip 710, the ear tip 810 can have a less pronounced angle or curve, depicted as A2. The angle A2 is defined as the angle between a central longitudinal axis of the proximal end of the ear tip 810 and a central longitudinal axis of the distal end of the ear tip 810. The angle A2 can be between about 5 and about 30 degrees, including all ranges and values therebetween. In an embodiment, the angle A2 can be at least about 5 degrees. As seen in FIGS. 8A-8B, the inlet channel 812 and the discharge channel 814 can be angled from the distal end to the proximal end of the ear tip 810. In some embodiments, the inlet channel 812 and the discharge channel 814 can be curved. In some embodiments, the inlet channel 812 and the discharge channel 814 can be at a straight angle (or have portions that are at a straight angle). In some embodiments, the angle or curve of the body of the ear tip 810 may be customized to the anatomical shape of the ear canal of a patient.
[0075] FIGS. 9A-9D depict various ear tips (e.g., functionally and/or structurally similar to the delivery element 110 of FIG. 1, the delivery elements 210 of FIG. 2, the delivery element 310 of FIG. 3, the delivery elements 510 of FIGS. 5A-5C, the long ear tip 710 of FIGS. 7A- 7D, and/or the short ear tip 810 of FIGS. 8A-8D) engaging an ear canal, according to embodiments. For illustrative purposes, the ear canal in FIGS. 9A-9D has the same dimensions for demonstrating the differences between various ear tips. In use though, the larger ear tips shown in FIGS. 9A-9B are configured for use with patient populations have larger ear canals, while the smaller ear tips shown in FIGS. 9C-9D are configured for use with patient populations with smaller ear canals.
[0076] FIG. 9 A depicts a regular long ear tip 910a. In some embodiments, the regular long ear tip 910a is structurally and/or functionally similar to the long ear tip 710 of FIG. 7. The regular long ear tip 910a, when inserted into the ear canal, ends at the isthmus of the ear canal. The regular long ear tip 910a is intended to remove earwax that is more medial in the ear canal. In some embodiments, the width of the regular long ear tip 910a can substantially fill the ear canal opening, which can reduce fluid leaks out of the ear canal during use of the regular long ear tip 910a. [0077] FIG. 9B depicts a regular short ear tip 910b. In some embodiments, the regular short ear tip 910b is structurally and/or functionally similar to the short ear tip 810 of FIG. 8. The regular short ear tip 910b, when inserted into the ear canal, ends at the aperture of the ear canal. The regular short ear tip 910b is intended to remove earwax that is more lateral in the ear canal. In some embodiments, the width of the regular short ear tip 910b can substantially fill the ear canal opening, which can reduce fluid leaks out of the ear canal during use of the regular long ear tip 910a.
[0078] FIG. 9C depicts a small long ear tip 910c. In some embodiments, the small long ear tip 910c is structurally and/or functionally similar to the long ear tip 710 of FIG. 7. As shown, the small long ear tip 910c can have a smaller width or profile such that it can be used for ear canals with smaller openings.
[0079] FIG. 9D depicts a small short ear tip 910d. In some embodiments, the small short ear tip 910d is structurally and/or functionally similar to the short ear tip 810 of FIG. 8. As shown, the small short ear tip 910d can have a smaller width or profile such that it can be used for ear canals with smaller openings.
[0080] FIGS. 10A-10D depict nozzles (e.g., structurally and/or functionally similar to the ear tip 712a of FIGS. 7A-7D and the ear tip 812a of FIGS. 8a-8D) of a various ear tips (e.g., functionally and/or structurally similar to the delivery element 110 of FIG. 1, the delivery elements 210 of FIG. 2, the delivery element 310 of FIG. 3, the delivery elements 510 of FIGS. 5A-5C, the long ear tips 710 of FIGS. 7A-7D, and/or the short ear tips 810 of FIGS. 8A-8D). The nozzles include openings that are angled to direct fluid towards a particular portion of the ear canal and/or to distribute fluid throughout the ear canal. Other nozzles may be possible than those in FIGS. 10A-10D. For example, the nozzles can include different numbers, orientations, and/or shapes of openings to match the ear canal of the patient.
[0081] FIGS. 10A-10B depict a long ear tip 1010 (e.g., structurally and/or functionally similar to the long ear tip 710 of FIGS. 7A-7D). A nozzle 1012a of the long ear tip 1010 includes three openings. As depicted in FIG. 10 A, the angle of the top two openings and a longitudinal axis of the distal end of a fluid channel 1012 is defined as angle Al. In some embodiments, the angle Al is between about 10 degrees and about 50 degrees, including all ranges and values therebetween. In some embodiments, the angle Al is between about 15 to about 20 degrees, or about 18 degrees. The angle between the bottom opening and the longitudinal axis of the distal end is defined as A2. In some embodiments, the angle A2 is between about 30 degrees and about 80 degrees, including all ranges and values therebetween. In some embodiments, the angle A2 is between about 55 and about 60 degrees, or about 58 degrees. As depicted in FIG. 10B, the angle between one opening and a vertical axis of the distal end of the long ear tip 1010 is defined as A3 and the angle between another opening and the vertical axis of the distal end is defined as A4. In some embodiments, the angle A3 and angle A4 are substantially equal. In some embodiments, the angle A3 and angle A4 are between about 20 degrees and about 60 degrees, including all ranges and values therebetween. In some embodiments, the angle A3 and the angle A4 are between about 40 to 50 degrees, or 45 degrees. In some embodiments, the third opening is in line with the vertical axis of the distal end.
[0082] Other angles and arrangements can be used, including arrangements where the openings are evenly distributed about a center axis of the nozzle, arrangements with more openings, etc. The positioning and/or arrangement of the openings can be optimized for cleaning different regions of the ear canal, for different patient populations, etc.
[0083] For example, FIGS. 10C-10D depict a short ear tip 1110 (e.g., structurally and/or functionally similar to the short ear tip 810 of FIGS. 8A-8D). A nozzle 1112a of the short ear tip 1110 includes three openings. The three openings of the short ear tip 1110 can be different from that of the long ear tip 1010, e.g., due to the area of the ear canal that the short ear tip 1110 is designed to clean. As depicted in FIG. 10C, the angle of the top two openings and a longitudinal axis of the distal end of a fluid channel 1112 is defined as angle A5. In some embodiments, the angle A5 is between about 10 degrees and about 50 degrees, including all ranges and values therebetween. In some embodiments, the angle A5 is about 36 degrees.
The angle between the bottom opening and the longitudinal axis of the distal end is defined as A6. In some embodiments, the angle A6 is between about 30 degrees and about 80 degrees, including all ranges and values therebetween. In some embodiments, the angle A6 is about 40 degrees. As depicted in FIG. 10D, the angle between one opening and a vertical axis of the distal end of the short ear tip 1110 is defined as A7 and the angle between another opening and the vertical axis of the distal end is defined as A8. In some embodiments, the angle A7 and angle A8 are substantially equal. In some embodiments, the angle A7 and angle A8 are between about 20 degrees and about 60 degrees, including all ranges and values therebetween. In some embodiments, the angle A4 and the angle A4 are about 30 degrees. In some embodiments, the third opening is in line with the vertical axis of the distal end.
[0084] FIGS. 11 A-l 1C depict a discharge reservoir 1130 including a first portion 1130a and a second portion 1130b, according to an embodiment. In some embodiments, the discharge reservoir 1130 is structurally and/or functionally similar to any of the discharge reservoirs described herein, such as the discharge reservoir 130 of FIG. 1, the discharge reservoir(s) 230 of FIG. 2, the discharge reservoirs 330 of FIG. 3A, and/or the discharge reservoir 530 of FIG. 5 A. The discharge reservoir 1130 is configured to store fluid discharged out of an ear canal during operation of an ear cleaning device, such as the ear cleaning device 100 of FIG. 1 and/or any ear cleaning device described herein. In some embodiments, the discharge reservoir 1130 is transparent or translucent so that a user can see the contents of the discharge reservoir 1130. The discharge reservoir 1130 is formed when the first portion 1130a is engaged with the second portion 1130b. The second portion 1130b is configured to be coupled to an earset (e.g., functionally and/or structurally similar to the earsets 201 and 201b of FIG. 2). The first portion 1130a is removable so that the discharge reservoir 1130 can be cleaned and so that the fluid can be removed.
[0085] FIG. 11 A depicts a perspective view of the first portion 1130a. The first portion 1130a includes a body 1131a with two recessed portion 1134 and an outlet 1132 (e.g., functionally and/or structurally similar to the outlet 332 of FIG. 3). The body 1131a forms a cavity that is configured to store liquid. The body 113 la is semi-circular and is configured to fit into an earset together with a fluid reservoir. The recessed portions 1134 are configured to accept a portion of the second portion 1130b so that the first portion 1130a and the second portion 1130 are sealed together when engaged. The outlet 1132 is configured to allow discharged fluid to exit the discharge reservoir 1130. In some embodiments, the outlet 1132 can be covered with a plug or valve configured to selectively allow or prevent discharged fluid from exiting the discharge reservoir 1130.
[0086] FIG. 1 IB depicts a perspective view of the second portion 1130b. The second portion 1130b includes a body 1131b, earset fasteners 1136b, container fasteners 1136a, a vacuum port 1138, and a vacuum shield 1139 (or shield). The body 113 lb is configured to match and engage with and fit into a recess in the earset. The body 1131b may be coupled to the earset. For example, the body 1131b can be clipped into, fastened, or adhered to the earset. The earset fasteners 1136b may be used to couple the second portion 1130b to the earset. The container fasteners 1136b are configured to engage the recessed portions 1134 of the first portion 1130a to couple the first portion 1130a to the second portion 1130b. The vacuum port 1138 can be configured to be connected to a vacuum source to remove air from the discharge reservoir 1130 to create a negative pressure for removing fluid from the ear canal, e.g., via the fluid discharge channel. The vacuum shield 1139 extends away from the body 1131b and engages the first portion 1130a as to prevent fluid from being removed from the discharge reservoir and entering the vacuum source. When the reservoir is assembly (i.e., the body 1131a and the body 1131b are coupled together), the shield extends from a first side of the reservoir to a second, opposing side of the reservoir, e.g., to prevent fluid from being removed from the discharge reservoir and entering the vacuum source. A small slot in the vacuum shield 1139 allows for air to flow out of the discharge reservoir 1130 while preventing nearly all water from reaching the vacuum source via the vacuum port 1138. The slot can be configured to allow air to pass therethrough such that the negative pressure can be generated in the second reservoir via the vacuum assembly while preventing liquid from passing therethrough (e.g., liquid including the liquid discharged from the ear canal, or the second volume of fluid).
[0087] FIG. 11C depicts a perspective view of the first portion 1130a and the second portion 1130b engage to form the discharge reservoir 1130. In some embodiments, the first portion 1130a and the second portion 1130b are sealed together via a sealant, press fit, gasket, and/or the like. The discharge reservoir 1130 defines a volume for storing discharged fluid.
[0088] The ear cleaning devices described herein are example embodiments of suitable ear cleaning devices. While certain features and/or components may be described with respect to one or more of the ear cleaning devices and not others, it can be appreciated that such features and/or components can be incorporated into any of the ear cleaning devices described herein. Additional examples of ear cleaning devices are also described in U.S. Patent Application No. 16/235,469, titled “Ear cleaning devices and methods,” filed December 28, 2018, the disclosure of which is incorporated herein by reference. Features and/or components of such ear cleaning devices can also be used with any of the ear cleaning devices described herein.
[0089] Detailed embodiments of the present disclosure are disclosed herein for purposes of describing and illustrating claimed structures and methods that may be embodied in various forms, and are not intended to be exhaustive in any way, or limited to the disclosed embodiments. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the disclosed embodiments. The terminology used herein was chosen to best explain the principles of the one or more embodiments, practical applications, or technical improvements over current technologies, or to enable those of ordinary skill in the art to understand the embodiments disclosed herein. As described, details of well-known features and techniques may be omitted to avoid unnecessarily obscuring the embodiments of the present disclosure.
[0090] References in the specification to “one embodiment,” “an embodiment,” “an example embodiment,” or the like, indicate that the embodiment described may include one or more particular features, structures, or characteristics, but it shall be understood that such particular features, structures, or characteristics may or may not be common to each and every disclosed embodiment of the present invention herein. Moreover, such phrases do not necessarily refer to any one particular embodiment per se. As such, when one or more particular features, structures, or characteristics is described in connection with an embodiment, it is submitted that it is within the knowledge of those skilled in the art to affect such one or more features, structures, or characteristics in connection with other embodiments, where applicable, whether or not explicitly described.
[0091] In the following description, certain specific details are set forth in order to provide a thorough understanding of various disclosed implementations. However, one skilled in the relevant art will recognize that implementations may be practiced without one or more of these specific details, or with other methods, components, materials, etc. In other instances, structures and solutions associated with ear cleaning, including the various components and ratios of such components in cleaning solutions, have not been shown or described in detail to avoid unnecessarily obscuring descriptions of the implementations. [0092] Unless the context requires otherwise, throughout the specification and claims which follow, the word “comprise” and variations thereof, such as “comprises” and “comprising,” are to be construed in an open, inclusive sense, that is, as “including, but not limited to.”
[0093] Reference throughout this specification to “one implementation” or “an implementation” means that a particular feature, structure, or characteristic described in connection with the implementation or implementations is included in at least one implementation or implementations. Thus, the appearances of the phrases “in one implementation” or “in an implementation” in various places throughout this specification are not necessarily all referring to the same implementation. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more implementation or implementations.
[0094] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. It should also be noted that the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
[0095] The headings and Abstract of the Disclosure provided herein are for convenience only and do not interpret the scope or meaning of the implementations.
[0096] While the present disclosure has been shown and described with reference to certain exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the present disclosure, as defined by the appended claims and their equivalents. Therefore, the embodiments of present disclosure have been provided by way of example for purposes of illustration, and not limitation.
[0097] Also, various inventive concepts may be embodied as one or more methods, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

Claims

CLAIMS What is claimed is:
1. An apparatus, comprising: a support structure including a coupling element detachably couplable to a delivery element and defining a cavity configured to receive an ear of a subject; a first reservoir couplable to the support structure and configured to contain a first volume of fluid; a first channel configured to provide fluid communication between the first reservoir and the coupling element such that the first volume of fluid can be delivered from the first reservoir to the coupling element; a second reservoir couplable to the support structure and configured to receive a second volume of fluid; a second channel configured to provide fluid communication between the second reservoir and the coupling element such that the second volume of fluid can be received in the second reservoir from the coupling element; and a delivery element coupled to the coupling element, the delivery element having a body that curves from a proximal end to a distal end of the delivery element.
2. The apparatus of claim 1, wherein the proximal end of the delivery element is angled relative to the distal end of the delivery element by an angle of between about 10 and about 50 degrees.
3. The apparatus of claim 1, wherein the delivery element includes an inlet channel and a discharge channel, the inlet channel and the discharge channel being curved from the proximal end to the distal end of the delivery element.
4. The apparatus of claim 1, wherein the delivery element includes a nozzle at the distal end of the delivery element that has at least three openings.
5. The apparatus of claim 4, wherein each of the openings is set at a different angle relative to the other openings.
6. An apparatus, comprising: a curved body configured to be inserted into an ear canal, the curved body having a proximal end that is angled relative to a distal end by an angle of between about 10 degrees and about 50 degrees, the curved body having a first portion that defines an inlet channel and a second portion that defines an outlet channel, the inlet and the outlet channels being curved from the proximal end to the distal end of the curved body; and a nozzle disposed at a distal end of the curved body, the nozzle including at least three openings configured to dispense fluid streams at different angles.
7. An apparatus, comprising: a support structure; an ear pad coupled to the support structure, the ear pad defining a cavity for receiving an ear of a subject when the ear pad is placed against a head of the subject, the ear pad including: a windowed portion configured to provide a line of sight into the cavity to confirm a placement of the ear within the cavity; and a drip catch configured to capture a portion of fluid used during an ear cleaning procedure that leaks from an ear canal of the subject; a first reservoir removably coupled to the support structure, the first reservoir configured to hold a first volume of the fluid prior to the ear cleaning procedure; and a second reservoir removably coupled to the support structure, the second reservoir configured to receive a second volume of the fluid used during the ear cleaning procedure via a channel defined in the support structure.
8. The apparatus of claim 7, wherein the second reservoir includes: a first port configured to receive the second volume of the fluid into the second reservoir; and a second port configured to couple to a vacuum assembly such that the vacuum assembly can generate a negative pressure within the second reservoir to draw the second volume of the fluid into the second reservoir.
9. The apparatus of claim 8, wherein, when the second reservoir is coupled to the support structure and the ear is received in the cavity, the second port is located near a superior side of the second reservoir.
10. The apparatus of any one of claims 8-9, wherein the second reservoir further includes a shield configured to surround at least a portion of the second port such that the second port is at least partially insulated from the second volume of the fluid received within the second reservoir.
11. The apparatus of claim 10, wherein the shield extends from a first side of the second reservoir to a second, opposing side of the second reservoir.
12. The apparatus of any one of claims 7-11, further comprising: a delivery element removably coupled to the support structure, the delivery element configured to deliver the first volume of the fluid into the ear canal and to receive the second volume of the fluid from the ear canal.
13. The apparatus of claim 12, wherein, when the ear is received in the cavity, the delivery element is configured to be inserted into the ear of the subject, the windowed portion configured to provide the line of sight into the cavity such that the placement of the delivery element in the ear canal can be confirmed.
14. The apparatus of any one of claims 12-13, wherein the windowed portion includes a recessed portion of the ear pad that defines a gap between the ear pad and the head of the user when the ear pad is placed against the head.
15. The apparatus of any one of claims 12-13, wherein the windowed portion includes a transparent or translucent portion of the ear pad.
16. The apparatus of any one of claims 12-15, wherein, when the ear is received in the cavity, the drip catch is located at an inferior side of the ear pad.
17. The apparatus of any one of claims 12-16, wherein, when the ear is received in the cavity, the drip catch is configured to be disposed below the ear canal such that the fluid that leaks from the ear canal is captured by the drip catch.
18. An apparatus, comprising: a support structure; a first reservoir removably coupled to the support structure, the first reservoir configured to hold a first volume of fluid for a cleaning procedure; a second reservoir removably coupled to the support structure, the second reservoir configured to receiving a second volume of fluid used during the cleaning procedure; a delivery element removably coupled to the support structure, the delivery element positionable within an ear canal of an ear during the cleaning procedure, the delivery element including: a first channel configured to deliver the first volume of fluid from the first reservoir to the ear canal; a nozzle in fluid communication with the first channel, the nozzle having at least three openings, each opening of the at least three openings being directed at a different angle relative to the other openings; a second channel configured to receive the second volume of fluid from the ear canal and to direct the second volume of fluid toward the second reservoir; and an opening in fluid communication with the second channel and configured to receive the second volume of fluid from the ear canal.
19. The apparatus of claim 18, wherein each opening of the at least three openings is angled from a longitudinal axis of the first channel.
20. The apparatus of claim 18, wherein first and second openings of the at least three openings are angled upward relative to a longitudinal axis of the first channel and laterally relative to the longitudinal axis of the first channel.
21. The apparatus of claim 20, wherein the first and second openings are angled between about 10 and about 50 degrees upward relative to the longitudinal axis of the first channel.
22. The apparatus of any one of claims 20-21, wherein the first opening is angled between about 20 to about 60 degrees to a left of the longitudinal axis of the first channel, and the second opening is angled between about 20 to about 60 degrees to a right of the longitudinal axis of the first channel.
23. The apparatus of any one of claims 20-22, wherein a third opening of the at least three openings is angled downward relative to the longitudinal axis of the first channel.
24. The apparatus of claim 23, wherein the third opening is angled downward between about 30 and about 80 degrees relative to the longitudinal axis of the first channel.
25. The apparatus of any one of claims 18-24, wherein the at least three openings are disposed distal to the opening in fluid communication with the second channel.
26. The apparatus of any one of claims 18-25, wherein the at least three openings have diameters that are substantially equal and are smaller than a diameter of the opening in fluid communication with the second channel.
27. The apparatus of any one of claims 18-26, wherein the delivery element has a body that curves from a proximal end to a distal end of the delivery element.
28. An apparatus, comprising: a support structure; a first reservoir removably coupled to the support structure, the first reservoir configured to hold a first volume of fluid for a cleaning procedure; a second reservoir removably coupled to the support structure, the second reservoir configured to receiving a second volume of fluid used during the cleaning procedure, the second reservoir including a port and a shield disposed around the port to shield the port from the second volume of fluid; a pump assembly disposed within the support structure and configured to pump the first volume of fluid from the first reservoir into an ear canal of a subject; and a vacuum assembly disposed within the support structure and configured to generate negative pressure within the second reservoir to draw the second volume of fluid into the second reservoir, the vacuum assembly being in fluid communication with the second reservoir via the port of the second reservoir.
29. The apparatus of claim 28, further comprising: an ear pad coupled to the support structure, the ear pad defining a cavity for receiving an ear when the ear pad is placed against a head of the subject, the ear pad including a windowed portion configured to provide a line of sight into the cavity to confirm a placement of the ear within the cavity.
30. The apparatus of claim 29, wherein the ear pad further includes a drip catch configured to capture a portion of the first volume of fluid used during the cleaning procedure that leaks from the ear canal of the subject.
31. The apparatus of any one of claims 28-30, further comprising a delivery element, the delivery element configured to be removably coupled to the support structure, the delivery element including a nozzle having at least three openings directed at a different angle relative to the other openings for delivering the first volume of fluid into the ear canal.
32. The apparatus of any one of claims 28-31, wherein the shield is configured to extend from a first side of the second reservoir to a second, opposing side of the second reservoir.
33. The apparatus of any one of claims 28-32, wherein the shield includes a slot configured to allow air to pass therethrough such that the negative pressure can be generated in the second reservoir via the vacuum assembly while preventing liquid of the second volume of fluid from passing therethrough.
34. A method, comprising: pumping fluid from a first reservoir through a first channel of an earpiece to a delivery element disposed within an ear canal of a subject; delivering the fluid into the ear canal through at least three openings of the delivery element, each opening of the at least three openings being directed at a different angle relative to the other openings; and generating negative pressure in a second reservoir to draw at least a portion of the fluid from the ear canal through the delivery element and a second channel of the earpiece into the second reservoir.
35. The method of claim 34, further comprising: heating the fluid to a predefined temperature prior to delivering the fluid into the ear canal.
PCT/US2024/030405 2023-05-22 2024-05-21 Ear cleaning devices Pending WO2024243228A1 (en)

Applications Claiming Priority (2)

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US202363503666P 2023-05-22 2023-05-22
US63/503,666 2023-05-22

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US20110301572A1 (en) * 2005-04-22 2011-12-08 Aner Vlodaver Medication delivery device
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US20110015489A1 (en) * 2009-07-14 2011-01-20 Puthalath Koroth Raghuprasad Otoscope with attachable ear wax removal device
US8840546B2 (en) * 2010-06-01 2014-09-23 The Board Of Trustees Of The Leland Stanford Junior University System for accessing a body orifice
US20190143029A1 (en) * 2016-06-30 2019-05-16 Safkan, Inc. Ear cleaning devices and methods
AU2019252798A1 (en) * 2018-04-13 2020-10-15 Stryker European Operations Holdings Llc Systems and methods of performing transcanal ear surgery

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