Probes to non-invasively reduce cerumen production and methods for using them

Abstract

Devices, systems, and methods are provided for removing or reducing cerumen from a subject. The system includes a probe comprising an elongate shaft including a proximal end, a distal end, a longitudinal axis extending between the proximal and distal ends, and an emitter on the distal end configured to transmit light or other forms of energy transversely relative to the longitudinal axis. A light source or other energy source is operatively coupled to the probe to deliver laser light or other form of energy to the emitter, e.g., to deliver the laser light to the ceruminous glands of a subject's ear to ablate tissue of the ceruminous glands and / or otherwise cerumen production or remove cerumen from the ear canal.

Description

PROBES TO NON-INVASIVELY REDUCE CERUMEN PRODUCTION AND METHODS FOR USING THEMRELATED APPLICATION DATA

[0001] The present application claims benefit of co-pending U. S. provisional application Serial No. 63 / 778,751, filed March 27, 2025, the entire disclosure of which is expressly incorporated by reference herein.TECHNICAL FIELD

[0002] The present application relates generally to medical devices and, more particularly, to devices, systems, and methods for reducing cerumen production and / or removing cerumen in subjects.BACKGROUND

[0003] Cerumen, also known as earwax, is produced by ceruminous glands located in the cartilaginous portion of the external auditory canal, which also includes hair follicles and sebaceous gland. Buildup of cerumen is a significant problem, affecting one in three elderly and developmentally-delayed individuals, one in ten children, and one in twenty adults in the United States. In the U. S., approximately twelve million individuals seek medical attention each year for issues related to cerumen, leading to nearly eight million cerumen removal procedures annually, and Medicare expenditures of about fifty million dollars for procedures related to cerumen. Furthermore, cerumen buildup is the main reason for hearing aid malfunction. It is estimated that over seven million people in the U. S. and approximately one hundred seventy million people worldwide use hearing aids.

[0004] Current medical treatments for cerumen focus on addressing impaction after it occurs rather than preventing excessive cerumen production. Furthermore, the existing procedures, e.g., using ceruminolytics, irrigation and manual removal, pose risks, including potential injury to the outer, middle or inner ear. Additionally, the first two methods are contraindicated for individuals with tympanic membrane perforations or active infections.

[0005] In addition to the unmet clinical need to reduce cerumen impaction in people, a similar veterinary need exists for some breeds of dogs, such as American Cocker Spaniels.

[0006] Accordingly, devices and methods that facilitate reducing cerumen production and / or removing cerumen in subjects would be useful.SUMMARY

[0007] The present application relates generally to medical devices and, more particularly, to devices, systems, and methods for removing cerumen and / or reducing cerumen production in subjects. In one example, a miniature, anatomically-sized laser probe is provided to non-invasively reduce cerumen production. Alternatively, the probe may use other forms of energy to ablate and / or otherwise treat tissue, such as electrical energy, e.g., radiofrequency (RF) energy, cryotherapy, or ultrasound. The probe may be configured to target ceruminous glands in a lateral aspect of an external auditory canal when non-invasively introduced into the ear canal of a subject. The probe may include an active surface or other element on a side that faces the skin, and may be manually or automatically rotated by the operator (a physician or advanced-practice practitioner) to treat the area where ceruminous glands are located circumferentially.

[0008] In one example, the outer diameter of the probe may be not more than about three millimeters (3 mm), e.g., to fit within the pediatric and adult ear canals smoothly. In children, the smallest maximum Feret diameter of the external auditory canal ranges from 6.5 to 10.1 mm (mean: 8.0 mm), and the smallest minimum Feret diameter ranges from 3.6 to 5.9 mm (mean: 5.1 mm) 10. In adults, the smallest maximum Feret diameter ranges from 6.9 to 15.0 mm (mean: 8.9 mm), and the smallest minimum Feret diameter ranges from 3.4 to 6.4 mm (mean: 5.4 mm). In one example, the length of the active surface may be not more than about eight millimeters (8 mm), e.g., since the length of the external auditory canal is approximately 2.5 cm in humans, and the ceruminous-gland containing part occupies the lateral third to half of the length. The probe dimensions may be modified as needed for dogs.

[0009] In accordance with one example, a system is provided for reducing cerumen production from a subject that includes a probe comprising an elongated shaft including a proximal end, a distal end sized for introduction into an ear canal of the subject’s ear, a longitudinal axis extending between the proximal and distal ends, and an emitter on the distal end configured to transmit light transversely relative to the longitudinal axis; and a light source operatively coupled to the probe to deliver light to the emitter such that theemitter transmits the light transversely relative to the longitudinal axis to treat tissue of a ceruminous gland of the ear.

[0010] In accordance with another example, a device is provided for reducing cerumen production by a subject that includes an outer shaft comprising a proximal end, a distal end sized for introduction into an ear canal of the subject’s ear, a lumen extending between the proximal and distal ends, and a longitudinal axis extending between the proximal and distal ends; an inner shaft received with the lumen comprising a distal end extending distally beyond the distal end of the outer shaft; an emitter on the distal end of the inner shaft configured to transmit light transversely relative to the longitudinal axis; a light source configured to deliver light to the emitter such that the emitter transmits the light transversely relative to the longitudinal axis; and a motor coupled to the inner shaft to rotate the inner shaft within the lumen, thereby rotating the emitter about the longitudinal axis such that the light is transmitted outwardly and circumferentially to deliver the light to treat to treat tissue of ceruminous glands of the ear adjacent to the ear canal.

[0011] In accordance with still another example, a device is provided for reducing cerumen production by a subject that includes an outer shaft comprising a proximal end, a distal end sized for introduction into an ear canal of the subject’s ear, a lumen extending between the proximal and distal ends, and a longitudinal axis extending between the proximal and distal ends; an inner shaft received with the lumen comprising a distal end extending distally beyond the distal end of the outer shaft; an emitter on the distal end of the inner shaft configured to energy transversely relative to the longitudinal axis; and a motor coupled to the inner shaft to rotate the inner shaft within the lumen, thereby rotating the emitter about the longitudinal axis such that the energy is transmitted outwardly and circumferentially to deliver the energy to tissue surrounding the distal end to ablate or otherwise treat tissue of ceruminous glands adjacent to the ear canal. In various examples, the emitter is configured to transmit one of laser light within the infrared band, transmit radiofrequency electrical energy, or focused ultrasound to treat the tissue.

[0012] In accordance with yet another example, a device is provided for reducing cerumen production by a subject that includes an outer shaft comprising a proximal end, a distal end sized for introduction into an ear canal of the subject’s ear, a lumen extending between the proximal and distal ends, and a longitudinal axis extending between the proximal and distal ends; an inner shaft received with the lumen comprising a distal end extending distally beyond the distal end of the outer shaft; a cryogenic probe on the distalend of the inner shaft configured to generate cryogenic energy transversely relative to the longitudinal axis; and a motor coupled to the inner shaft to rotate the inner shaft within the lumen, thereby rotating the emitter about the longitudinal axis such that the energy is transmitted outwardly and circumferentially to deliver the energy to tissue surrounding the distal end to ablate or otherwise treat tissue of ceruminous glands adjacent to the ear canal.

[0013] In accordance with another example, a method is provided for reducing cerumen production by a subject that includes inserting a distal end of a probe into an ear canal of the subject, the distal end comprising an emitter oriented transversely relative to a longitudinal axis of the probe; manipulating the probe to position the emitter adjacent to ceruminous glands of the subject’s ear; activating the emitter to deliver energy from the emitter; and rotating the probe to deliver the energy through skin of the ear canal to the ceruminous glands to ablate tissue of the ceruminous glands to reduce cerumen production. In various examples, the emitter may transmit one of laser light within the infrared band, radiofrequency electrical energy, or focused ultrasound, or may generate cryoenergy to ablate the tissue.

[0014] Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] It is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:

[0016] FIG. 1 shows an example of a system for reducing cerumen including a probe and a light source for providing laser light to an emitter on the distal end of the probe.

[0017] FIG. 2 is a detail showing a distal end of another probe that may be included in a system for reducing cerumen production.

[0018] FIG. 3 shows the distal end of the probe of FIG. 1 being inserted into a subject’s ear.

[0019] FIGS. 4A and 4B are cross-sections of samples of tissue within a porcine ear canal showing the location of ceruminous glands below the skin.

[0020] FIG. 5 is a cross-section of a tissue sample showing ablation of ceruminous glands below the skin of an ear canal.

[0021] The drawings are not intended to be limiting in any way, and it is contemplated that various examples of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.DETAILED DESCRIPTION

[0022] The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[0023] Before the examples are described, it is to be understood that the invention is not limited to particular examples described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular examples only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[0024] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0025] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which thisinvention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and exemplary methods and materials are now described.

[0026] It must be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a compound” includes a plurality of such compounds and reference to “the polymer” includes reference to one or more polymers and equivalents thereof known to those skilled in the art, and so forth.

[0027] Certain ranges are presented herein with numerical values being preceded by the term “about.” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.

[0028] The term “substantially” is used throughout this document to indicate variations in the thus qualified terms. These variations are variations that do not materially affect the manner in which the invention works and can be due, for example, to uncertainty in manufacturing processes or to small deviations from a nominal value or ideal shape that do not cause significant changes to the invention. Also, the terminology “proximal” and “distal” refers to a position relative to an operator using the present disclosure on a patient. For example, distal elements are closer to an intervention site, e.g., a patient’s skin, and proximal elements are closer to an operator, for example, a doctor or other caregiver using the devices herein.

[0029] Turning to the drawings, FIG. 1 shows an example of a system 8 for reducing cerumen production and / or removing cerumen within an ear 90 of a subject, e.g., as shown in FIG. 3. For example, the system 8 may be used to treat tissue of the ceruminous glands 94 adjacent the ear canal 92, e.g., to ablate the tissue to reduce production of cerumen. The system 8 may be used to reduce cerumen production in human subjects or animal subjects, e.g., dogs, as described further elsewhere herein.

[0030] Generally, the system 8 includes a probe 10 including an elongated shaft 20 operatively coupled to a light source 50. The shaft 20 includes a proximal end 22, a distal end 24 sized for introduction into an ear canal 92 of an ear 90, e.g., as shown in FIG. 3, anddefining a longitudinal axis 26 between the proximal and distal ends 22, 24. The distal end 24 may terminate in a tapered, rounded, and / or other atraumatic distal tip 25, e.g., to minimize risk of damage to tissue and / or structures within the ear. Optionally, a stop may be provided on the shaft 20, e.g., a circumferential flange or other feature (not shown) extending radially outwardly from the shaft 20. The stop may be provided at a predetermined distance from the distal tip 25, e.g., to prevent over-insertion of the distal end 24 into the subject’s ear and reduce risk of damage to the tympanic membrane and / or other structures within the ear.

[0031] As shown in FIG. 1, an emitter 30 is provided on the distal end 24 including one or more features oriented transversely relative to the longitudinal axis 26, e.g., on one side of the distal end 24. The emitter 30 is configured to transmit light from the light source 50 radially outwardly from the distal end 24, e.g., in a beam 32 centered on beam axis 32, which may be substantially perpendicular to the longitudinal axis 26 as shown (or alternatively, may be oriented at other angles lateral to the longitudinal axis 26, if desired). One or more lenses, prisms, mirrors, and / or other features (not shown) may be provided on or within the distal end 24 that are optically coupled to the light source 50 such that the beam 32 has a desired shape, e.g., a conical beam that expands transversely from the emitter 30 as shown. Alternatively, the emitter 30 may generate a narrow beam or multiple beams (not shown) that are transmitted transversely from the distal end 24, e.g., substantially perpendicular to the longitudinal axis 26. The emitter 30 may be coupled to the light source 50 via one or more optical fibers and / or optical couplers (not shown) within the shaft 20, as described further elsewhere herein.

[0032] With continued reference to FIG. 1, a handle or hub 40 may be provided on the shaft 20, e.g., on or adjacent to the proximal end 22, which may be sized and / or shaped to facilitate manipulating the probe 10. The hub 40 may include a connector 44 optically coupled to the optical fiber(s) in the shaft 20 and configured to releasably (or permanently) connect a cable 52 from the light source 50, thereby optically coupling the light source 50 to the emitter 30. Optionally, an actuator 42 may be provided on the hub 40, e.g., button or switch configured to activate / deactivate the emitter 30, as desired to deliver the light from the emitter 30. In addition or alternatively, the light source 50 may include an actuator, e.g., an on / off switch (not shown), that may be used to turn the light source 50 on and off in addition to or instead of the actuator 42. In another option, a foot pedal or other actuator(not shown) may be provided that may be coupled to the probe 10 and / or light source 50 to activate / deactivate the emitter 30.

[0033] As shown, the light source 50 includes a separate console or housing 54 containing a laser or other light generator 56 that is coupled to the probe 10 by the cable 52. The console 54 may be manually turned on and off and / or otherwise controlled by the operator. Alternatively, the light source 50 may include a controller (not shown) that may be programmed to automatically operate the laser 56 in a desired manner during delivery of the light to the subject when activated.

[0034] Alternatively, the laser may be incorporated in the probe 10, e.g., mounted within the hub 40, and coupled to optical fiber(s) that extend through the shaft 20 to the emitter 30. In this alternative, the probe 10 may include a power source, e.g., a battery and / or a cable (not shown) for connecting the probe 10 to an outlet or other external source of electricity.

[0035] The shaft 20 may be substantially rigid between the proximal and distal ends 22, 24 to facilitate manipulation of the distal end 24 within the ear canal. For example, the shaft 20 may be substantially straight such that an operator holding the hub 40 may rotate the hub 40 to rotate the distal end 24 directly.

[0036] Alternatively, as shown in FIG. 2, a probe 110 may be provided that includes an inner shaft 120 that may be rotated to rotate the distal end 124 about longitudinal axis 126 by a motor or other device. For example, as shown, the probe 110 may include an outer shaft 146 that is attached to or otherwise fixed relative to the hub 140 and extends distally from the hub 130 along the longitudinal axis 126. The outer shaft 146 includes a lumen 148 within which the inner shaft 120 is received such that the inner shaft 120 is free to rotate about the longitudinal axis 126 within the outer shaft 120.

[0037] The distal end 124 is attached or otherwise coupled to the inner shaft 120 and is located distal to the outer shaft 146 such that the distal end 124 rotates with the inner shaft 120. For example, the distal end 124 and the outer shaft 146 may have the same diameter to provide a substantially uniform profile along the probe 110. An emitter 130 is provided on the distal 124, similar to the emitter 30 on the probe 10. In the example shown, the emitter 130 includes a lens 136 mounted on a side wall of the distal end 124 and a prism 136 that is optically coupled to the lens 136 and to one or more optical fibers (one fiber 128 shown). Thus, light from the light source may pass through the optical fiber 128 and be redirected by the prism 136 substantially ninety degrees, and then through the lens 136,which generates the beam 132 along beam axis 134. Alternatively, one or more mirrors or other optical components may be provided in the emitter 130, e.g., between the optical fiber 128 and the lens 136 to direct the resulting beam 132 transversely relative to the longitudinal axis 126. In addition, an optical coupler may be provided between the optical fiber 128 and the prism 136, e.g., to allow light to pass from the optical fiber 128 to the prism 136 while the distal end 124 rotates (and the optical fiber 128 remains stationary within the inner shaft 120).

[0038] In this alternative, a motor, e.g., a piezoelectrically driven mechanism (not shown), may be provided within the hub 140 and / or other location within the probe 110 that is coupled to the inner shaft 120. The hub 140 may include an actuator (not shown) coupled to the motor to activate and deactivate rotation of the inner shaft 120. Optionally, the actuator may also adjust a speed of the motor to adjust the speed at which the distal end 124 rotates when activated. In a further alternative, the probe 110 may be coupled to a console or other external controller, e.g., within a light source, that may control operation of the probe 110, e.g., to activate the light source and rotate the distal end 124 at desired parameters, e.g., rotation speed and / or duration, to deliver the laser light to ablate or otherwise treat tissue of the ceruminous glands.

[0039] Generally, the light source 50 may include a laser configured to generate light within the infrared band, e.g., between about seven hundred nanometers and one millimeter (700 nm-1.0 mm), such that the light transmitted by the emitter 30 may pass through skin of the ear canal and ablate or otherwise treat tissue of the ceruminous glands, e.g., to reduce production of cerumen. For example, the light source 50 may be configured to generate light within the near-infrared band, e.g., between about 700-2500 nanometers, or within the far-infrared band, e.g., between about ten micrometers and one millimeter (10 µm-1.0 mm).

[0040] In one example, the light source 50 may include a CO2 laser, e.g., configured to generate light at a narrow band centered on a desired wavelength, e.g., centered at a wavelength of about 10600 nanometers (10.6 µm). In other examples, the light source 50 may include an alexandrite laser, e.g., configured to generate laser light at a wavelength of about 755 nm, a diode laser, e.g., configured to generate laser light at a wavelength of about 810 nm, or a YAG laser, e.g., configured to generate laser light at a wavelength of about 1,064 nm.

[0041] Alternatively, the system may use other forms of energy to reduce or remove cerumen, e.g., to ablate tissues of the ceruminous glands. For example, one or more electrodes (not shown) may be provided on the distal end that may be coupled to an electrical generator (in place of light source 50), which may be configured to generate radiofrequency alternating current. In further alternatives, the probe may be configured to deliver cryotherapy or focused ultrasound to tissue surrounding the ear canal to ablate or otherwise treat the ceruminous glands, as described elsewhere herein.

[0042] In various examples, the shaft 20 may have an outer diameter between about two and four millimeters (2-4 mm), e.g., typically not more than about three millimeters (3.0 mm), and / or an overall length between about twenty and two hundred millimeters (20-200 mm), e.g., not more than about eight millimeters ( 8 mm) of the active area.

[0043] Turning to FIG. 3, during use, the distal end 24 of the probe 10 may be inserted into an ear canal 92 of a subject’s ear 90 to position the emitter 30 adjacent ceruminous glands 94 of the ear 90. The light source 50 may be activated to deliver laser light from the emitter 30, and then the distal end 24 may be rotated to deliver the laser light transversely from the probe 10 and circumferentially around the ear canal 92. For example, an operator, e.g., a physician or other medical professional, may manipulate the probe 10 using the hub 40 to position the emitter 30 and then manually rotate the shaft 20 to deliver the laser light to the ceruminous glands to reduce cerumen production.

[0044] Alternatively, the probe 10 may be carried by a robotic arm or other support apparatus (not shown), which may be manipulated directly or actuated remotely to insert the probe 10 and / or rotate the shaft 20 to deliver the laser light. In this alternative, the robotic arm or support apparatus may be programmable to limit insertion of the probe 10 into a subject’s ear, e.g., to prevent over-insertion of the distal end 24 into the subject’s ear and reduce risk of damage to the tympanic membrane and / or other structures within the ear. Rotation of the probe 10 may be controlled by the operator using an external console or, alternatively, the apparatus may be programmed to rotate the probe 10 and / or activate the light source to generate a predetermined plan for treatment.

[0045] In a further alternative, the probe 110 may be used to automatically deliver laser light to ablate or otherwise treat tissue of the ceruminous glands. For example, the distal end 124 of the probe 120 may be inserted into the ear canal 92 (manually or via a robotic arm or other apparatus), similar to the probe 10 shown in FIG. 3, and positioned until the emitter 130 is located adjacent the ceruminous glands 94. Once positioned asdesired, the light source may be activated and (thereafter or simultaneously) the motor of the probe 110 may be activated to rotate the distal end 124 and deliver the laser light circumferentially around the ear canal 92. As discussed above, the laser light may pass through the skin of the ear canal 92 and ablate or otherwise damage the ceruminous glands 94 to reduce subsequent cerumen production. The duration and / or rotation speed may be set automatically by a controller or the operator may manually adjust the speed and maintain the treatment for a desired duration. Once treatment is complete, the light source may be deactivated and the probe 10, 110 removed from the ear canal 92.

[0046] Alternatively, the systems and methods herein may involve other energy delivery methods, instead of laser light, to effectively target cerumen glands. For example, radiofrequency ablation and cryoablation, which currently have commercial applications in the head and neck region, primarily for sinus treatments, may be used to ablate and / or otherwise reduce cerumen production by the ceruminous glands. Cryoablation and radiofrequency may offer a method to ablate the ceruminous glands without causing significant pain given that these procedures are already well-tolerated on awake patients in clinic after topical anesthesia.

[0047] For example, a probe may be provided to deliver cryotherapy at -60-80 C. Such treatments have been used to target the posterior nasal nerve for rhinitis, e.g., at depths up to about three millimeters. Given that the present systems and methods treat a different tissue type (ear canal skin) with a depth target of only about five hundred micrometers (500 μM), the duration of delivery of cryotherapy may be between about five and fifteen (5-15) seconds, e.g., about ten (10) seconds to sufficiently reach this depth and effectively ablate tissue of the ceruminous glands. Similarly, for radiofrequency ablation, the tissues may be heated to about 60-80 C to target a depth of about five hundred micrometers (500 μM). In a further alternative, one or more acoustic transducers may be provided on the distal end of the probe (instead of the emitter ) that are configured to generate ultrasound to ablate or otherwise treat tissue of the ceruminous glands. For example, the transducer(s) may be configured to generate focused ultrasound that targets the ceruminous glands below the skin, thereby minimizing damage to the skin and / or other structures within the ear.

[0048] The following describes experiments involving deliver of laser light to samples of ear canals to perform ablation of ceruminous glands. Ear canal skin samples were acquired from pigs (60-100 kg) and rabbits (10-15 kg) immediately after death from the Stanford Veterinary Service Center (VSC). The histological analysis of the porcine earcanal was conducted, and hematoxylin and eosin staining performed to highlight its structural features. This revealed that most of the cerumen glands were situated at or below five hundred micrometers (500 μm) of depth, as can be seen in FIG, 4A and 4B This depth is significant, as laser ablation may sufficiently reach these depths without issue based on prior literature and current clinical applications in dermatology.

[0049] A CO2 laser (Ultrapulse Duo) was utilized to administer several fractionated laser treatments (40 mJ via three passes) to study its effects on the cerumen gland surface. This level of power delivery was able to sufficiently deliver enough energy to reach the ceruminous glands without issue, as can be seen in FIG. 5. However, the CO2 laser’s inherent wavelength properties (10600 nm) required very specialized optics (mirrors and lenses) to properly bend the beam to nineth degrees (90°) (or other variation) to allow a side firing probe design.

[0050] Based on the depth of the ceruminous glands, following fractionated laser settings were found during the experiments using a commercial Cutera laser: 5-20 ms pulse duration, fluctuance 20 J / cm2, 2-3 passes.

[0051] While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.

Claims

WE CLAIM:

1. A system for reducing cerumen production by a subject, comprising:a probe comprising an elongate shaft including a proximal end, a distal end sized for introduction into an ear canal of the subject’s ear, a longitudinal axis extending between the proximal and distal ends, and an emitter on the distal end configured to transmit light transversely relative to the longitudinal axis; anda light source operatively coupled to the probe to deliver light to the emitter such that the emitter transmits the light transversely relative to the longitudinal axis to treat tissue of a ceruminous gland of the ear.

2. The system of claim 1, wherein the shaft is rigid.

3. The system of claim 1, wherein the light source is configured to generate infrared light to penetrate skin of the ear canal and ablate tissue of a ceruminous gland of the subject.

4. The system of claim 3, wherein the light source is configured to generate infrared light between about 700-2500 nanometers.

5. The system of claim 3, wherein the light source is configured to generate infrared light between about ten micrometers and one millimeter (10 μm-1.0 mm).

6. The system of claim 5, wherein the light source comprises a CO2 laser configured to generate light at a wavelength of about 10600 nanometers (10.6 μm).

7. The system of any one of claims 1 -6, wherein the probe comprises one or more optical fibers extending between the proximal and distal ends and optically coupled to the emitter to deliver light from the light source to the emitter.

8. The system of claim 7, wherein the light source comprises a console including a laser configured to deliver the light to the emitter.

9. The system of claim 8, wherein the console is coupled to the probe by a cable including one or more optical fibers optically coupled to the one or more optical fibers in the shaft,10. The system of claim 7, wherein the light source comprises a laser within a hub of the probe configured to deliver the light to the emitter via the one or more optical fibers.

11. The system of any one of claims 1-6, wherein the probe comprises a hub on the proximal end and motor coupled to the distal end and configured to rotate the distal end about the longitudinal axis such that the light is transmitted outwardly and circumferentially to deliver the light to tissue surrounding the distal end.

12. The system of claim 11, further comprising an actuator configured to control the motor to activate and deactivate the motor.

13. The system of claim 12, wherein the actuator is further configured to adjust a rotation speed of the motor and the distal end.

14. The system of claim 11, further comprising a controller operatively coupled to the motor to control the motor to rotate for a predetermined speed and duration to deliver the light to the tissue surrounding the distal end.

15. The system of any one of claims 1-6, further comprising a stop on the probe to limit insertion of the distal end into the ear canal.

16. The system of claim 15, wherein the stop is located on the shaft at a predetermined distance from a distal tip of the shaft.

17. A device for reducing cerumen production by a subject, comprising:an outer shaft comprising a proximal end, a distal end sized for introduction into an ear canal of the subject’s ear, a lumen extending between the proximal and distal ends, and a longitudinal axis extending between the proximal and distal ends;an inner shaft received with the lumen comprising a distal end extending distally beyond the distal end of the outer shaft;an emitter on the distal end of the inner shaft configured to transmit light transversely relative to the longitudinal axis;a light source configured to deliver light to the emitter such that the emitter transmits the light transversely relative to the longitudinal axis; anda motor coupled to the inner shaft to rotate the inner shaft within the lumen, thereby rotating the emitter about the longitudinal axis such that the light is transmitted outwardly and circumferentially to deliver the light to treat to treat tissue of ceruminous glands of the ear adjacent to the ear canal.

18. The device of claim 17, further comprising an actuator configured to control the motor to activate and deactivate the motor.

19. The device of claim 18, wherein the actuator is further configured to adjust a rotation speed of the motor and the distal end.

20. The device of claim 17, further comprising a controller operatively coupled to the motor to control the motor to rotate for a predetermined speed and duration to deliver the light to the tissue surrounding the distal end.

21. The device of any one of claims 17-20, wherein the probe comprises one or more optical fibers extending between the proximal and distal ends and optically coupled to the emitter to deliver light from the light source to the emitter.

22. The device of claim 21, wherein the light source comprises a console including a laser configured to deliver the light to the emitter.

23. The device of claim 22, wherein the console is coupled to the probe by a cable including one or more optical fibers optically coupled to the one or more optical fibers in the shaft.

24. The device of claim 21, wherein the light source comprises a laser within the hub configured to deliver the light to the emitter via the one or more optical fibers.

25. The device of any one of claims 17-20, wherein the outer shaft is rigid between the proximal and distal ends.

26. The device of any one of claims 17-20, wherein the light source is configured to generate infrared light to penetrate skin of the ear canal and ablate tissue of a ceruminous gland of the subject.

27. A device for reducing cerumen production by a subject, comprising:an outer shaft comprising a proximal end, a distal end sized for introduction into an ear canal of the subject’s ear, a lumen extending between the proximal and distal ends, and a longitudinal axis extending between the proximal and distal ends;an inner shaft received with the lumen comprising a distal end extending distally beyond the distal end of the outer shaft;an emitter on the distal end of the inner shaft configured to energy transversely relative to the longitudinal axis; anda motor coupled to the inner shaft to rotate the inner shaft within the lumen, thereby rotating the emitter about the longitudinal axis such that the energy is transmitted outwardly and circumferentially to deliver the energy to tissue surrounding the distal end to ablate or otherwise treat tissue of ceruminous glands adjacent to the ear canal.

28. The device of claim 27, wherein the emitter is configured to transmit laser light within the infrared band to treat the tissue.

29. The device of claim 27, wherein the emitter is configured to transmit radiofrequency electrical energy to treat the tissue.

30. The device of claim 27, wherein the emitter is configured to transmit focused ultrasound to treat the tissue.

31. A device for reducing cerumen production by a subject, comprising:an outer shaft comprising a proximal end, a distal end sized for introduction into an ear canal of the subject’s ear, a lumen extending between the proximal and distal ends, and a longitudinal axis extending between the proximal and distal ends;an inner shaft received with the lumen comprising a distal end extending distally beyond the distal end of the outer shaft;a cryogenic probe on the distal end of the inner shaft configured to generate cryogenic energy transversely relative to the longitudinal axis; anda motor coupled to the inner shaft to rotate the inner shaft within the lumen, thereby rotating the emitter about the longitudinal axis such that the energy is transmitted outwardly and circumferentially to deliver the energy to tissue surrounding the distal end to ablate or otherwise treat tissue of ceruminous glands adjacent to the ear canal.

32. A method for removing or reducing cerumen from a subject, comprising: inserting a distal end of a probe into an ear canal of the subject, the distal end comprising an emitter oriented transversely relative to a longitudinal axis of the probe; manipulating the probe to position the emitter adjacent ceruminous glands of the subject’s ear;activating a light source to deliver light from the emitter; androtating the probe to deliver the light through skin of the ear canal to the ceruminous glands to reduce cerumen production or remove cerumen.

33. The method of claim 32, wherein the probe is rotated manually to direct the laser circumferentially around the ear canal to the ceruminous glands.

34. The method of claim 32, wherein rotating the probe comprises activating an actuator to rotate the distal end of the probe to deliver the light circumferentially around the ear canal.

35. A method for reducing cerumen production by a subject, comprising: inserting a distal end of a probe into an ear canal of the subject, the distal end comprising an emitter oriented transversely relative to a longitudinal axis of the probe; manipulating the probe to position the emitter adjacent ceruminous glands of the subject’s ear;activating the emitter to deliver energy from the emitter; androtating the probe to deliver the energy through skin of the ear canal to the ceruminous glands to ablate tissue of the ceruminous glands to reduce cerumen production.

36. The method of claim 35, wherein the emitter transmits laser light within the infrared band to ablate the tissue.

37. The method of claim 35, wherein the emitter transmits radiofrequency electrical energy to ablate the tissue.

38. The method of claim 35, wherein the emitter transmits focused ultrasound to ablate the tissue.

39. The method of claim 35, wherein the emitter generates cryoenergy to ablate the tissue.

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