# US 11,026,738 B2 · Devices and methods for treating a lateral surface of a nasal cavity

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- Number: US 11,026,738 B2
- Document ID: US11026738B2
- Status: Granted
- Kind: B2
- Application number: 15/624,632
- Filed: 2017-06-15
- Published: 2018-05-10
- Granted: 2021-06-08
- Earliest claimed: 2016-06-15
- Assignees: Arrinex, Inc.
- Applicants: Arrinex, Inc.
- Inventors: Vahid Saadat; William Jason Fox; Mojgan Saadat
- Web page: https://patentgrep.com/patent/US11026738B2

## CPC

- A61B 18/02: by cooling, e.g. cryogenic techniques
- A61B 17/24: for use in the oral cavity, larynx, bronchial passages or nose (for medical inspection of cavities or tubes in the body A61B1/00); Tongue scrapers
- A61F 7/123: {using a flexible balloon containing the thermal element}
- A61B 2017/003: {Steerable}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/00946: {malleable}
- A61B 2017/00991: {Telescopic means}
- A61B 2018/00196: {reciprocating lengthwise}
- A61B 2018/0022: {Balloons}
- A61B 2018/00327: {Ear, nose or throat}
- A61B 2018/00434: {Neural system}
- A61B 2018/00577: {Ablation}
- A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter}
- A61B 2018/0231: {Characteristics of handpieces or probes}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS 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 (dental prosthetics A61C)

## Abstract

The invention disclosed here generally relates to devices that can modify a property of a nerve. Specifically, the subject invention is contemplated to modify the posterior nasal nerve signal conduction in such a way so as to reduce the signals transmitted to the nasal cavity. Reduction or interruption of the nerve signals results in the reduction of the distal organ activity. In particular, embodiments of the present invention allow for increased lateral contact or apposition of the target tissue region having at least one posterior nasal nerve with the end effector surface by lateral and/or longitudinal translation of the end effector relative to the surgical probe shaft. This improved lateral surface contact has several benefits, including improved patient outcomes and patient safety as the end effector is adequately in contact with target tissue for subsequent ablation therapy.

## Claims

### Claim 1

A method for treating a tissue region within a nasal cavity of a patient, the method comprising:
inserting a distal end of a surgical probe into the nasal cavity of the patient through a nostril of the patient in a first configuration, wherein the surgical probe comprises an outer shaft, an inner shaft positioned within a lumen of the outer shaft and translatable relative to the outer shaft, and an end effector coupled to a distal end of the inner shaft, wherein, in the first configuration, the inner shaft is in a proximal-most position relative to the outer shaft, wherein the end effector is coupled to the distal end of the inner shaft at a non-zero angle relative to a longitudinal axis of the distal end of the inner shaft in the first configuration, and wherein a distal portion of the inner shaft in the first configuration is substantially aligned with a longitudinal axis of the outer shaft and the end effector is positioned a first distance from a distal end of the outer shaft such that an entirety of the end effector is positioned distal to the lumen of the outer shaft in the first configuration;
advancing the distal end of the surgical probe into the nasal cavity with the surgical probe in the first configuration;
translating the inner shaft relative to the outer shaft so that the surgical probe is deployed to a second configuration, wherein the end effector is translated longitudinally to a second distance greater than the first distance away from the distal end of the outer shaft and laterally away from the longitudinal axis of the outer shaft, wherein the end effector in the second configuration is positioned within proximity of the tissue region having at least one posterior nasal nerve; and
ablating the at least one posterior nasal nerve of the tissue region with the end effector.

### Claim 2 (depends on 1)

The method of claim 1, further comprising initially contacting the end effector with an anatomical feature of a middle meatus to a lateral wall of the nasal cavity prior to translating the inner shaft relative to the outer shaft.

### Claim 3 (depends on 2)

The method of claim 2, wherein translating the inner shaft relative to the outer shaft further comprises translating from a posterior portion of the tissue region to an anterior portion of the tissue region so that a surface of the end effector successively increases lateral contact with the tissue region.

### Claim 4 (depends on 3)

The method of claim 3, wherein the first distance of the end effector from the distal end of the outer shaft is a range from less than 10 mm and the second distance of the end effector from the distal end of the outer shaft is in a range from 5 mm to 20 mm.

### Claim 5 (depends on 3)

The method of claim 3, wherein a lateral translation of the end effector away from the longitudinal axis of the outer shaft is in a range from 10 degrees to 90 degrees.

### Claim 6 (depends on 1)

The method of claim 1, wherein the outer shaft comprises an angled tip defining an angle between the distal portion of the inner shaft in the second configuration and the longitudinal axis of the outer shaft.

### Claim 7 (depends on 1)

The method of claim 1, wherein the inner shaft comprises a flexible or self-expandable material.

### Claim 8 (depends on 1)

The method of claim 1, wherein the inner shaft comprises a biased stylet, wherein translating the biased stylet relative to the outer shaft deploys the surgical probe from the first configuration where the biased stylet is constrained by the outer shaft in a substantially straightened configuration to the second configuration where the biased stylet is unconstrained by the outer shaft in a curved configuration to articulate the end effector laterally away from the longitudinal axis of the of the outer shaft.

### Claim 9 (depends on 1)

The method of claim 1, further comprising maintaining the outer shaft substantially stationary relative to the nostril while translating the inner shaft relative to the outer shaft.

### Claim 10 (depends on 1)

The method of claim 1, wherein nostril stretching by the outer shaft is inhibited while translating the inner shaft relative to the outer shaft.

### Claim 11 (depends on 1)

The method of claim 1, further comprising maintaining the outer shaft at an orientation substantially parallel to a sagittal plane of the patient while translating the inner shaft relative to the outer shaft.

### Claim 12 (depends on 1)

The method of claim 1, wherein the end effector comprises an expandable structure coupled to the distal end of the inner shaft and an inner member is disposed at the distal end of the inner shaft extending within the expandable structure which encloses the inner member such that the inner member is unattached to an interior of the expandable structure.

### Claim 13 (depends on 12)

The method of claim 12, further comprising introducing a cryogenic fluid into the expandable structure such that the expandable structure inflates from a deflated configuration into an expanded configuration against the tissue region, wherein the cryogenic fluid evaporates within the expandable structure so as to cryogenically ablate the at least one posterior nasal nerve.

### Claim 14 (depends on 13)

The method of claim 13, further comprising maintaining the inner member against the interior of the expandable structure and the tissue region until the at least one posterior nasal nerve is cryogenically ablated.

### Claim 15 (depends on 12)

The method of claim 12, wherein the inner member comprises a first member and a second member, wherein the inner member is configurable from an expanded configuration wherein the first member and second member define a first width of the end effector between the first member and the second member, to a compressed configuration wherein the first member and the second member define a second width of the end effector that is smaller than the first width.

### Claim 16 (depends on 15)

The method of claim 15, wherein the inner member is in the compressed configuration when the distal end of the surgical probe is inserted into the nostril and in the expanded configuration when the end effector is positioned within the tissue region having the at least one posterior nasal nerve.

### Claim 17 (depends on 15)

The method of claim 15, wherein the first width is in a range from 10 mm to 20 mm.

### Claim 18 (depends on 17)

The method of claim 17, wherein the first member and second member do not overlap in the expanded configuration.

### Claim 19 (depends on 15)

The method of claim 15, wherein the second width is in a range from 5 mm to 19 mm.

### Claim 20 (depends on 19)

The method of claim 19, wherein the first member and second member overlap in the compressed configuration.

### Claim 21 (depends on 15)

The method of claim 15, wherein the first and second members comprise a heart shape in the expanded configuration and an oblong shape in the compressed configuration.

### Claim 22 (depends on 12)

The method of claim 12, wherein the inner member comprises a planar member having an elongate loop shape.

### Claim 23

A surgical probe for treating a tissue region within a nasal cavity of a patient, the surgical probe comprising:
an outer shaft having a distal end configured for insertion into a nostril of the nasal cavity of the patient, the outer shaft having a longitudinal axis and a lumen therethrough;
an inner shaft positioned within the lumen of the outer shaft and translatable relative to the outer shaft; and
an end effector coupled to a distal end of the inner shaft, wherein a distal portion of the inner shaft is substantially aligned with the longitudinal axis of the outer shaft and the end effector is positioned a first distance from the distal end of the outer shaft such that an entirety of the end effector is positioned distal to the lumen of the outer shaft when the surgical probe is in a first configuration during insertion and advancement of the surgical probe into the nasal cavity, wherein, in the first configuration, the inner shaft is in a proximal-most position relative to the outer shaft wherein the end effector is coupled to the distal end of the inner shaft at a non-zero angle relative to a longitudinal axis of the distal end of the inner shaft in the first configuration, and wherein a translation of the inner shaft relative to the outer shaft configures the end effector longitudinally to a second distance greater than the first distance away from the distal end of the outer shaft and laterally away from the longitudinal axis of the outer shaft when the surgical probe is in a second configuration, wherein the end effector in the second configuration is in lateral contact with the tissue region having at least one posterior nasal nerve and is configured to ablate the at least one posterior nasal nerve.

### Claim 24 (depends on 23)

The surgical probe of claim 23, where the end effector is configured to initially contact an anatomical feature of a middle meatus to a lateral wall of the nasal cavity prior to the translation of the inner shaft relative to the outer shaft.

### Claim 25 (depends on 24)

The surgical probe of claim 24, wherein the end effector is configured to successively increase lateral contact with the tissue region from a posterior portion of the tissue region to an anterior portion of the tissue region during the translation of the inner shaft relative to the outer shaft.

### Claim 26 (depends on 23)

The surgical probe of claim 23, wherein the first distance of the end effector from the distal end of the outer shaft is a range from less than 10 mm and the second distance of the end effector from the distal end of the outer shaft is in a range from 5 mm to 20 mm.

### Claim 27 (depends on 23)

The surgical probe of claim 23, wherein the end effector is configured to translate away from the longitudinal axis of the outer shaft in a range from 10 degrees to 90 degrees.

### Claim 28 (depends on 23)

The surgical probe of claim 23, wherein the outer shaft comprises an angled tip defining an angle between the distal portion of the inner shaft in the second configuration and the longitudinal axis of the outer shaft.

### Claim 29 (depends on 23)

The surgical probe of claim 23, wherein the inner shaft comprises a flexible or self-expandable material.

### Claim 30 (depends on 23)

The surgical probe of claim 23, wherein the inner shaft comprises a biased stylet, wherein the biased stylet is configured to translate relative to the outer shaft and configured to deploy the surgical probe from the first configuration where the biased stylet is constrained by the outer shaft in a substantially straightened configuration to the second configuration where the biased stylet is unconstrained by the outer shaft in a curved configuration to articulate the end effector laterally away from the longitudinal axis of the of the outer shaft.

### Claim 31 (depends on 23)

The surgical probe of claim 23, wherein the end effector comprises an expandable structure coupled to the distal end of the inner shaft and an inner member is disposed at the distal end of the inner shaft extending within the expandable structure which encloses the inner member such that the inner member is unattached to an interior of the expandable structure.

### Claim 32 (depends on 31)

The surgical probe of claim 31, wherein the expandable structure is configured to receive a cryogenic fluid into the expandable structure such that the expandable structure is configured to inflate from a deflated configuration into an expanded configuration against the tissue region, and wherein the expandable structure is configured so that the cryogenic fluid evaporates within the expandable structure so as to cryogenically ablate the at least one posterior nasal nerve.

### Claim 33 (depends on 31)

The surgical probe of claim 31, wherein the inner member comprises a first member and a second member, wherein the inner member is configurable from an expanded configuration wherein the first member and second member define a first width of the end effector between the first member and the second member, to a compressed configuration wherein the first member and the second member define a second width of the end effector that is smaller than the first width.

### Claim 34 (depends on 33)

The surgical probe of claim 33, wherein the inner member is configured to be in the compressed configuration when the distal end of the surgical probe is inserted into the nostril and in the expanded configuration when the end effector is positioned within the tissue region having the at least one posterior nasal nerve.

### Claim 35 (depends on 33)

The surgical probe of claim 33, wherein the first width is in a range from 10 mm to 20 mm.

### Claim 36 (depends on 35)

The surgical probe of claim 35, wherein the first member and second member are configured to not overlap in the expanded configuration.

### Claim 37 (depends on 33)

The surgical probe of claim 33, wherein the second width is in a range from 5 mm to 19 mm.

### Claim 38 (depends on 37)

The surgical probe of claim 37, wherein the first member and second member are configured to overlap in the compressed configuration.

### Claim 39 (depends on 33)

The surgical probe of claim 33, wherein the first and second members comprise a heart shape in the expanded configuration and an oblong shape in the compressed configuration.

### Claim 40 (depends on 31)

The surgical probe of claim 31, wherein the inner member comprises a planar member having an elongate loop shape.

### Claim 41 (depends on 23)

The surgical probe of claim 23, wherein the end effector comprises a cryotherapy balloon, wherein the surgical probe further comprises a cryogenic fluid source coupled to the inner shaft and a lumen disposed in the inner shaft and in fluid communication with the cryogenic fluid source and an interior of the cryotherapy balloon.

### Claim 42 (depends on 23)

The surgical probe of claim 23, wherein the end effector is coupled to a flexible inner shaft.

### Claim 43 (depends on 23)

The surgical probe of claim 23, wherein the inner shaft has a curvature or bend located a distance proximally from the end effector, wherein the curvature or bend is pre-formed.
