DEVICES AND METHODS FOR ENDOSCOPIC NEUROABLATION IN THE TYMPANIC CAVITY
20230200637 · 2023-06-29
Inventors
- Dorna HAKIMIMEHR (Redwood City, CA, US)
- Suresh Subraya Pai (Los Altos, CA, US)
- Marc Richard Dean (Dallas, TX, US)
Cpc classification
A61B18/1485
HUMAN NECESSITIES
A61B18/1482
HUMAN NECESSITIES
A61B1/07
HUMAN NECESSITIES
A61B18/0218
HUMAN NECESSITIES
A61B2018/0212
HUMAN NECESSITIES
A61B1/05
HUMAN NECESSITIES
A61B2018/00005
HUMAN NECESSITIES
A61B2018/00214
HUMAN NECESSITIES
A61B2018/00982
HUMAN NECESSITIES
International classification
A61B1/05
HUMAN NECESSITIES
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
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DETAILED DESCRIPTION OF THE INVENTION
[0067] In order to provide clarity regarding the relevant anatomical structures of the ear,
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[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.
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[0072] Optional cutting component 306 can be used to create the desired tympanic membrane incision 202 (described previously in
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[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.
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[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
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[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
[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.
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[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.
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[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.
[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
While individual steps are illustrated and described in
[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.