DEVICES AND METHODS FOR ENDOSCOPIC NEUROABLATION IN THE TYMPANIC CAVITY

20230200637 · 2023-06-29

    Inventors

    Cpc classification

    International classification

    Abstract

    The various embodiments described herein provide devices and methods for neuroablation in the tympanic cavity. Devices include an ablation effector that can be navigated into the tympanic cavity to ablate nerves therein in order to treat diseases caused due to the malfunction of these nerves.

    Claims

    1. A method for treating dysfunctions or diseases in a patient, comprising: creating access to a tympanic cavity of a patient; introducing a treatment device into the tympanic cavity of the patient, the treatment device having a proximal end, a distal end, an elongate shaft therebetween, and an ablation effector disposed at or near the distal end of the device; advancing the distal end of the device under direct visualization into proximity of a nerve or nerves within the tympanic cavity; and ablating the nerve or nerves using the ablation effector to reduce at least one symptom of nerve dysfunction or disease.

    2. The method of claim 1 wherein ablating the nerve or nerves comprises ablating a tympanic nerve.

    3. The method of claim 1 wherein ablating the nerve or nerves comprises ablating a tympanic plexus.

    4. The method of claim 1 wherein ablating the nerve or nerves comprises ablating a chorda tympani.

    5. The method of claim 1 wherein ablating the nerve or nerves comprises ablating a lesser petrosal nerve.

    6. The method of claim 1 wherein ablating the nerve or nerves comprises ablating a deep petrosal nerve.

    7. The method of claim 1 wherein ablating the nerve or nerves comprises ablating a nervous intermedious.

    8. The method of claim 1 wherein ablating the nerve or nerves comprises ablating a communicating branch of a facial nerve to a tympanic plexus.

    9. The method of claim 1 wherein ablating the nerve or nerves comprises ablating Arnold's nerve.

    10. The method of claim 1 wherein ablating the nerve or nerves comprises ablating a portion or branch of a facial nerve or a greater petrosal nerve.

    11. The method of claim 1 wherein ablating the nerve or nerves comprises ablating a portion of caroticotympanic nerves.

    12. The method of claim 1 wherein the dysfunctions or diseases to be treated is selected from the group consisting of otitis media, otitis media with effusion, chronic otitis media with effusion, chronic suppurative otitis media, referred otalgia, otalgia from a TMJ disorder, otic neuralgia, fistula of parotid gland, parotitis, Frey syndrome, autonomic dysfunction, disturbances of sense of tase including hypogeusia, ageusia or dysgeusia, excessive drooling, headache, retronasal olfaction, orosensory hyperactivity, and obesity.

    13. The method of claim 1 wherein creating access to the tympanic cavity comprises making an incision on a tympanic membrane.

    14. The method of claim 13 wherein a diameter of the incision on the tympanic membrane does not exceed 3 mm.

    15. The method of claim 1 wherein the treatment device includes a cutting component to create an incision on a tympanic membrane.

    16. The method of claim 1 wherein creating access to the tympanic cavity comprises making an incision in an external ear canal and elevating a tympanomeatal flap.

    17. The method of claim 1 wherein creating access to the tympanic cavity comprises following a facial recess approach.

    18. The method of claim 1 wherein the distal end of the treatment device includes a visualization or image capture component.

    19. The method of claim 18 wherein the visualization or image capture component of the device is a CMOS camera.

    20. The method of claim 18 wherein the ablation effector of the distal end of the treatment device is configured to be positioned in a field of view of the visualization or image capture component.

    21. The method of claim 18 wherein the distal end of the device includes an illumination component.

    22. The method of claim 21 wherein the ablation effector of the distal end of the treatment device is configured to slide axially relative to the visualization or image capture component and the illumination component.

    23. The method of claim 18 wherein the treatment device includes a heating or cooling component to protect the visualization or image capture component from temperature changes caused by the ablation effector.

    24. The method of claim 1 wherein advancing the distal end of the device comprises reconfiguring an expandable structure to transition from a collapsed configuration to an expanded configuration.

    25. The method of claim 1 wherein ablating the nerve or nerves comprises ablating the nerve or nerves via cryoablation.

    26. The method of claim 1 wherein ablating the nerve or nerves comprises ablating via heat using bipolar radiofrequency, pulsed radiofrequency, microwave, or ultrasonic energy.

    27. The method of claim 1 wherein ablating the nerve or nerves comprises ablating the nerve or nerves via ethanol and/or phenol.

    28. The method of claim 1 wherein ablating the nerve or nerves comprises ablating the nerve or nerves via a therapeutic agent.

    29. The method of claim 28 wherein the therapeutics agent includes capsaicin and its analogues, sympatholytic agents, and/or centrally acting agents.

    30. The method of claim 1 wherein ablating the nerve or nerves comprises ablating via a cryogenic ablation agent delivered through the distal end of the treatment device.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0057] FIG. 1A shows the schematic side view of the structures of an ear.

    [0058] FIG. 1B is the schematic of structures, including the nerves, within the tympanic cavity (middle ear) of an ear.

    [0059] FIG. 2A shows the schematic of the device of the current invention accessing the tympanic cavity through the external ear canal and tympanic membrane.

    [0060] FIG. 2B shows the distal end of the device of the current invention advanced through the incision in the tympanic membrane and positioned within the tympanic cavity in proximity with or in direct contact with some or all of the nerve(s) targeted for ablation.

    [0061] FIG. 3A shows a schematic cross-sectional view of the distal end segment of the device of the invention along with its components.

    [0062] FIG. 3B-3D shows schematics of various configurations of the ablation effector component of the distal end segment of the device in relation to other components of the device.

    [0063] FIGS. 4A-4C shows various configurations of the device depicting the distal end in varying configuration relative to the elongate shaft. FIG. 4A shows the distal end of the device in line with the elongate shaft. FIG. 4B shows the distal end of the device sitting an angle in relation to the elongate shaft. FIG. 4C shows the device's elongate shaft having a steerable section at its junction with the distal end allowing for in-situ adjustment of the angle of the distal end relative to the elongate shaft.

    [0064] FIG. 5A depicts a configuration of the device and systems of the current invention wherein a gas/liquid cartridge, a control mechanism to axially slide the distal end and/or its ablation component, and an image processing component are located within the proximal end of the device (shown in a device handle) which is in turn connected to an external light source and display device.

    [0065] FIG. 5B depicts a configuration of the device and systems of the current invention wherein where only the control mechanism to axially slide the distal end and/or its ablation component are housed within the proximal end of the device while other components are housed external to the proximal end (or device handle).

    [0066] FIG. 6 outlines a step-by-step method to use the devices described in this invention to treat diseases via endoscopic neuroablation in the tympanic cavity.

    DETAILED DESCRIPTION OF THE INVENTION

    [0067] In order to provide clarity regarding the relevant anatomical structures of the ear, FIG. 1A shows the auricle 100, external auditory canal 101, tympanic membrane 102 and the promontory of the tympanic cavity 103. FIG. 1B shows a simplified close-up picture of the tympanic cavity with tympanic membrane 102, promontory 103, tympanic nerve, a branch of the glossopharyngeal nerve, 104, tympanic plexus, combination of tympanic nerve with sympathetic fibers from the internal carotid nerve, 105, lesser petrosal nerve 106 and chorda tympani 107 a branch of the facial nerve 108.

    [0068] FIG. 2A shows a schematic of the device of the current invention 200 comprising proximal end 200A, elongate shaft 200B and distal end 200C. The proximal end 200A is used by an operator to navigate the distal end through the auricle 201, across the external ear canal 202, through an incision in the tympanic membrane 203 to enter tympanic cavity 204 in proximity to the promontory 205. The length of elongate shaft 200B is designed so that proximal end 200A (e.g., the device handle) remains outside of the patient's ear while distal end 200C is positioned in proximity to structures within tympanic cavity 204. The length of elongate shaft 200B is about 5-30 cm, or preferably within the range of 10 cm to 20 cm. FIG. 2B shows a close-up of the tympanic cavity 204, where the distal end 200C of device 200 has been navigated through incision 206 in the tympanic membrane 203. Incision 206 can be created using standard surgical technique and instruments prior to inserting device 200 into the patient's ear or it can be created using device 200 on its way to tympanic cavity 204. The diameter of incision 206 is about 0.5 mm to 3 mm, or preferably between 1 mm to 2.5 mm. Once inside tympanic cavity 204, distal end 200C is used to ablate targeted nerve tissues including, but not limited to the tympanic nerve 207, tympanic plexus 208, lesser petrosal nerve 209 or chorda tympani 210.

    [0069] In one embodiment, in addition to ablating a nerve or nerves, device 200 is configured to illuminate and visualize the inside of tympanic cavity 204 to identify the targeted nerve or nerves and perform the procedure.

    [0070] In yet another embodiment (not shown), instead of incision 206 of the tympanic membrane 203 to access the tympanic cavity 204, an incision can be made in external ear canal 202 in proximity to the tympanic membrane 203 in order to elevate a portion of tympanic membrane 203 in form of a flap to provide distal end 200C access to tympanic cavity 203.

    [0071] FIG. 3A shows the cross-section of distal end 300 of the device of the current invention comprising lumen 301, ablation effector 302, optional image capture component 303, optional illumination component 304, optional working channel 305, and optional cutting component 306. The diameter of distal tip 300 is such that it can navigate through a small incision in the tympanic membrane if desired and in general operate within the confines of the tympanic cavity space and is expected to be 1 mm to 3 mm or preferably between 1 mm to 2.5 mm in diameter.

    [0072] Optional cutting component 306 can be used to create the desired tympanic membrane incision 202 (described previously in FIG. 2B). In one embodiment, optional cutting component 306 is designed to slide back and forth axially along all or part of the elongate shaft of the device (not shown). In another embodiment, optional cutting component 306 is designed to rotate around the perimeter of distal end 300. In yet another embodiment, optional cutting component 306 is designed to rotate around the perimeter of distal end 300 and slide along elongate shaft of the device (not shown). In one example of this configuration, initially optional cutting component 306 is positioned in the proximity of proximal shaft of the device (not shown). Once distal end 300 is navigated through the external ear canal and is positioned in the proximity of tympanic membrane (not shown), cutting component 306 is slid forward towards distal end 300 so that it comes in contact with the tympanic membrane (not shown). Cutting component 306 then rotates along the perimeter of distal end 300 while in contact with the tympanic membrane to create an incision. Once the desired incision is created, cutting component 306 is slid backward (e.g. retracted) towards the proximal end of the device (not shown) placing its cutting surface along the elongate shaft in a position that facilitates safe delivery of the device as required into the tympanic cavity.

    [0073] FIG. 3B shows the side view distal end 300 comprising ablation effector 302, optional image capture component 303, optional illumination component 304, and optional working channel 305. In one embodiment of this invention, ablation effector 302 is in line and on the same plane as other components of distal end 300.

    [0074] In one embodiment of the current invention ablation effector 302 is a cryoprobe using Joule's Thompson (JT) effect to create temperatures between, e.g., −20° C. to −100° C. to effect nerve ablation. In this embodiment, a compressed refrigerant gas or liquid is ported through the cryoprobe via a small internal lumen to the proximity of the tip of the cryoprobe at which point the refrigerant gas or liquid exits the internal smaller lumen to enter a coaxial larger lumen. The refrigerant gas or liquid may be contained within a reservoir located within the proximal end or externally of the proximal end and coupled to the ablation effector 302 through the elongate shaft 200B. The expansion of the refrigerant gas or liquid during transition from the smaller lumen to the larger lumen generates extremely low (cryogenic) temperatures at the tip of the cryoprobe.

    [0075] In one embodiment of this invention, ablation effector 302 is a cryoprobe that uses compressed nitrous oxide gas or liquid to create the extremely low temperatures. In another embodiment, the refrigerant gas or liquid may comprise carbon dioxide as the refrigerant and in yet another embodiment, the refrigerant may comprise a chlorofluorocarbon, hydrochlorofluorocarbon, hydrofluorocarbon or any mixtures thereof to produce the extremely low temperatures.

    [0076] In one embodiment, ablation effector 302 is a cryoprobe that uses liquid nitrogen to produce extreme low temperatures. In yet another embodiment, ablation effector 302 uses other methods than JT effect to produce the extremely low temperatures necessary for tissue ablation.

    [0077] In another embodiment, ablation effector 302 uses heat to ablate tissue. The heat for ablation can be produced by various energy modalities including, but not limited to bipolar radiofrequency, pulsed radiofrequency, microwave or ultrasonic energy.

    [0078] In one embodiment, ablation effector 302 delivers liquid or semi-liquid chemicals unto the target tissue to effect ablation. Examples of such chemicals include ethanol, phenol, or formulations or combinations thereof.

    [0079] In another embodiment, ablation effector 302 delivers liquid or semi-liquid therapeutic agents to induce ablation. Examples of such agents include, but are not limited to capsaicin and its analogues (e.g. Zucapsaicin, ALGRX-4975, Nonivamide, Resiniferatoxin, or combinations thereof), sympatholytic agents such as alpha- and beta-adrenergic receptor antagonists (e.g., alpha and beta blockers), or centrally acting agents such as clonidine, guanabenz, methyldopa, minoxidil, and reserpine.

    [0080] In one embodiment, the diameter of ablation effector 302 is about 0.5 mm to 3 mm. In a preferred embodiment, the diameter of ablation effector 302 is between 0.5 mm to 2 mm.

    [0081] In one embodiment, optional image capture 303 is a miniature or subminiature CMOS and optional illumination component 304 is fiber optic bundle connected to an external light source (not shown). In another embodiment, optional illumination component 304 is a light emitting diode (LED) or alternatively a laser light source. The CMOS would be positioned proximal to a glass or plastic lens (also not shown) used to provide the desired focal length and field of view within the tympanic cavity.

    [0082] FIG. 3C shows the side view of distal end 300 comprising ablation effector 302′, optional image capture component 303, optional illumination component 304, and optional working channel 305, where ablation effector 302′ is positioned distal (slide forward axially) relative to the other components shown at distal end 300. This configuration allows for better visualization of the ablation procedure occurring at the tip of ablation effector 302′ by positioning it in the field of view (e.g., in front of or distal to) the image capture component 303.

    [0083] In one embodiment, ablation effector 302′ is positioned about 1 mm to 25 mm distal to other components of distal end 300. In another embodiment, the distance between the most distal tip of ablation effector 302′ relative to the other components of distal end 300 is between 1 mm to 10 mm or even more preferably between 1 mm to 5 mm.

    [0084] In one embodiment, the ablation effector 302′ is designed to slide axially back and forth relative to other components of distal end 300. During navigation to the tympanic cavity, ablation effector 302′ is in line with other components of distal end 300. Once within the tympanic cavity and after the nerve tissue targeted for ablation is visually identified, ablation effector 302 (as depicted in FIG. 3B) is slid forward (distally) relative to other components of distal end 300 to the position of ablation effector 302′ (as depicted in FIG. 3C) placing the distal most tip of the ablation effector 302 in front of or distally and within the field of view and focal length of image capture component 303. Upon completion of the procedure and prior to navigating out of the tympanic cavity, ablation effector 302′ is slid backward or retracted axially to position of ablation effector 302 (as depicted in FIG. 3B) in line with other components of distal end 300 facilitating navigation of the device out of the patient's ear.

    [0085] FIG. 3D shows a side view of distal end 300 comprising ablation effector 302″, image capture component 303, illumination component 304, and optional working channel 305. In this configuration, ablation effector 302″ has an expandable tip. During navigation to the target tissue, ablation effector 302″ is in a collapsed state to facilitate navigation (similar to ablation effector 302′ depicted in FIG. 3C). Once ablation effector 302″ is in proximity to the targeted tissue or nerve(s), it can change form a collapsed state to an expanded state to facilitate ablation of larger surface area of tissue possibly also improving conformity of ablation effector 302″ to uneven tissue surface morphologies. Upon completion of the ablation procedure and prior to navigation (e.g., retraction) out of a patient's ear, ablation effector 302″ is returned to the collapsed state (similar to ablation effector 302′ as depicted in FIG. 3C) to ease retraction from the anatomy and to reduce unintended trauma or tissue damage during retraction.

    [0086] It is contemplated that ablation effector 302″ can also slide axially relative to other components of distal end 300 in addition to assuming collapsed and expanded states. For example, during navigation to the target tissue, ablation effector 302″ can be arranged in line with other components of distal end 300 (in a configuration similar to ablation effector 302 depicted in FIG. 3B). Once effector 302″ is in proximity of targeted tissue, it can be slid forward (e.g., distally or axially) relative to other components of distal end 300 (in a configuration similar to ablation effector 302′ depicted in FIG. 3C) and change from collapsed state to expanded state. Upon completion of the ablation procedure, ablation effector 302″ can then revert back to its original collapsed state and slide backward axially to line it up with other components of distal end 300 prior to navigation (e.g., retraction) out of the patient's ear.

    [0087] In one embodiment the ablation effector 302″ is a cryoprobe using the Joule's Thompson (JT) effect to create temperatures between −20° C. to −100° C. to effect ablation and the expandable portion of ablation effector 302″ is a balloon. In this configuration the refrigerant gas used to cause JT effect is also used to simultaneously expand the balloon. Upon the completion of the ablation procedure, the flow of the refrigerant gas is stopped bringing the temperature of ablation effector 302″ back to environmental temperatures at the same time causing deflation of the balloon.

    [0088] In another embodiment, the expandable portion of ablation effector 302″ is a structure can be fabricated from thermally conductive materials capable of assuming a collapsed and an expanded state. In one embodiment, the thermally conductive material is a metal (e.g. Nitinol) which can be expanded and collapsed based on the shape-memory properties of the material.

    [0089] FIG. 4A depicts the schematic of device 400 of this invention with proximal end 400A, elongate shaft 400B and distal tip 400C. In this embodiment distal tip 400C is in line (on axis with) and in a straight configuration relative to elongate shaft 400B. FIG. 4B depicts device 400 where distal end 400C sits at an angle relative to elongate shaft 400B. It is contemplated that the angle between distal end 400C and elongate shaft 400B is between, e.g., 0 degrees to 120 degrees. In a preferred embodiment, this angle is between, e.g., 0 degrees to 90 degrees. The contemplated angle is designed to facilitate and ease access to nerve tissues situated at various angles relative to the entry point (e.g., the incision point in the tympanic membrane) of device 400 into tympanic cavity.

    [0090] In one embodiment of the current invention, distal tip 400C includes a specific bend angle at distal end 400C. In another embodiment, elongate shaft 400B is composed of a malleable material or construction that allows intraprocedural adjustment or tailoring or bending of distal end 400C by the operator in accordance with the specific geometric or anatomic requirements of a specific patient's ear.

    [0091] FIG. 4C depicts a schematic of device 400 wherein elongate shaft 400B has a steerable portion 401, the movement of which can be controlled by the operator. In this embodiment, the bend angle between distal end 400C relative to elongate shaft 400B can be adjusted in-situ (intraprocedurally) as desired by the operator.

    [0092] FIG. 5A depicts the schematic of device 500 comprising proximal end 500A, elongate shaft 500B and distal end 500C, where distal end 500C comprises a cryoprobe as ablation effector (not shown) and a working channel component (not shown). Proximal end 500A houses lumen 501 that can optionally be connected to a vacuum source using tubing 502 or can be used to pass surgical tools from proximal end 500A through elongate shaft 500B to the surgical site. Lumen 501 is connected to the working channel of the device (not shown). Proximal end 500A also houses compressed liquid or gas refrigerant cartridge 503 which is in fluid communication with distal tip 500C. Control mechanism 504 is also placed within proximal end 500A. Control mechanism 504 allows the operator to control the movement of the ablation effector, adjust the bend angle of distal tip 500C relative to elongate shaft 500B, and/or control the movements of the cutting component of distal end 500C (not shown). Image processing component 505 is in wireless communication with the image capture device of distal end 500C (not shown) and in electronic communication with image display device 507 through cable 506. Proximal end 500A is connected to external light source 508 through cable 509. Cable 509 is in communication with the illumination component of distal end 500C (not shown).

    [0093] As middle ear surgery involves operating in small spaces and around delicate/sensitive anatomical structures, and in order to provide the operator with better control and more precise manipulation of the device of the current invention, it would be preferrable to reduce the weight and volume of the proximal end 500A of the device. FIG. 5B depicts schematics of device 500 with proximal end 500A, elongate shaft 500B and distal end 500C. Proximal end 500A houses lumen 500A that can be optionally connected to a vacuum source through tube 502 or be used as a general-purpose working channel. It also houses control mechanism 504 that can control the movement and operation of the ablation effector (not shown), distal end 500C in relation to elongate shaft 500B, and/or the cutting component (not shown). Compressed liquid or gas refrigerant cartridge 503 and image processing component 506 are housed within external structure 508 along with the illumination light source. Cartridge 503 is in liquid communication with proximal end 500A and distal end 500C through tube 510. Image processing component 506 can be in wireless communication with image capture device component of distal end 500C (not shown) and electronically connected to image display device 507 using cable 505′in the form of, e.g., an HDMI or USB connector or the like well-known in the art. Proximal end 500A is connected to external light source 508 through cable 509. Cable 509 is in communication with the illumination component of distal end 500C (not shown).

    [0094] It is contemplated herein that portions of the various previously described embodiments may be rendered disposable thereby eliminating or reducing the cost and burden of instrument cleaning, reprocessing or resterilization where practicable.

    [0095] Possible configurations of components are not limited to embodiments described herein. Other configurations to impart practicality and/or ease of use to the device are contemplated by the authors.

    [0096] Step by step methods of using devices of current invention to treat diseases related to nerves innervating or passing through tympanic cavity are depicted in FIG. 6 (steps 6a to 6k) and are as follows: [0097] a. Consult with the patient and ascertain that the patient is a candidate for the current procedure, [0098] b. Apply necessary anesthesia, [0099] c. Create access to the inside of the tympanic cavity, [0100] d. Navigate the distal end of the device through the external ear canal and into the tympanic cavity under direct visualization, [0101] e. Identify the target nerve or nerves within the tympanic cavity under direct visualization, [0102] f. Position the ablation component at the distal end of the device on the desired location on the nerve trajectory and in direct contact with all or a portion of said nerve or nerves under direct direct visualization, [0103] g. Ablate all or a portion of said nerve or nerves, [0104] h. Stop the ablation procedure once the desired amount of ablation of the target nerve or nerves is completed, [0105] i. Repeat steps “f” to “i” of this method as required to further ablate the same or different nerve or nerves in the tympanic cavity, [0106] j. Retract the device out of the tympanic cavity and through the external ear canal to remove said device from the patient. [0107] k. Repair the access site as necessary.
    While individual steps are illustrated and described in FIG. 6, some of the steps may be optionally omitted in other embodiments and/or taken in a different order as desired or necessary. Furthermore, any combination of device features described may be used in any of the methods described in any number of combinations.

    [0108] Prior to the ablation procedure the physician might conduct a diagnostic procedure to ensure of the suitability of the ablation target. In some embodiments such diagnostic step might include injecting or applying an anesthetic to the target location.

    [0109] Direct visualization includes but not limited to using an endoscopes, rigid or flexible, or a microscope.

    [0110] In one embodiment of the method, the device includes or directly incorporates the visualization and/or illumination components. In another embodiment separate visualization and/or illumination instruments or tools are used.

    [0111] In one embodiment of the method, in order to access the tympanic cavity, an incision is made on the tympanic membrane. In another embodiment, an incision is made in the external ear canal in the proximity of the tympanic membrane to elevate a tympanomeatal flap to provide access to the tympanic cavity. In another embodiment facial recess approach is used to access the tympanic cavity.

    [0112] In one embodiment of the methods, the device includes a cutting component that can be used to create access to tympanic cavity, thereby combining the elements of steps c and d.

    [0113] In one embodiment of the method described herein, the step to identify the target nerve or nerves can include using a nerve tissue visualization aid (e.g. dyes) or other techniques to distinguish nerve tissue from surrounding tissues. In another embodiment, the step to identify target nerve includes methods of nerve stimulation or nerve monitoring commonly known in the art.

    [0114] In one embodiment of the method contemplated in this invention, the ablation effector component of the device is a cryoprobe that can provide temperatures in the range of, e.g., −20° C. to −100° C. to effect cryoablation of the main branch of the tympanic nerve and/or the tympanic plexus located on or near the promontory of the tympanic cavity of a patient. In this example, the method and devices described herein are used to treat dysfunctions and/or diseases including, but not limited to referred otalgia (e.g. otalgia from TMJ disorders), otic neuralgia, glossopharyngeal neuralgia, headache such as migraine, parotid gland fistula, parotitis, drooling, autonomic dysfunction and/or the Frey syndrome.

    [0115] In another embodiment of the method contemplated in this invention, the ablation effector component of the device is a cryoprobe that can provide temperatures in the range of −20° C. to −100° C. degrees to effect cryoablation of the chorda tympani nerve located in the tympanic cavity of a patient. In this example, the method and devices described herein are used to treat dysfunctions and/or diseases including, but not limited to taste disturbances, such as autonomic dysfunction, hypogeusia, ageusia or dysgeusia, excessive drooling, retronasal olfaction, or orosensory hyperactivity such as burning mouth syndrome.

    [0116] In another embodiment of the method contemplated in this invention, the ablation component of the device is a cryoprobe that uses temperatures in the range of −20° C. to −100° C. degrees to effect cryoablation of both the chorda tympani nerve and the tympanic nerve located in the tympanic cavity of a patient for example to treat obesity.

    [0117] In another embodiment of the method contemplated in this invention, the ablation component of the device is a cryoprobe that uses temperatures in the range of −20° C. to −100° C. degrees to effect cryoablation of Arnold's nerve.

    [0118] After the cryoablation of the target nerve, the patient will lose the function of that nerve for a period of time, after which the nerve is expected to regenerate into healthy tissue or nerve tissue exhibiting substantially less dysfunction than prior to the ablation procedure. In some patients, it might be necessary to repeat the procedure to improve efficacy or to extend the duration of the ablative (therapeutic) effects on the targeted nerve or nerves.

    [0119] Other medical therapies such as use of pharmaceutical agents can be conducted in combination with the methods described herein in order to improve the clinical outcomes of the patient.