Apparatus and methods for treating rhinitis

• US 9,763,723 B2
• Filed: 08/19/2016
• Issued: 09/19/2017
• Est. Priority Date: 09/30/2013
• Status: Active Grant

• Current Assignee: Arrinex, Inc. (Stryker Corporation)
• Original Assignee: Arrinex, Inc. (Stryker Corporation)
• Inventors: Saadat, Vahid
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): GOOD, SAMANTHA M
• Application Number:
  US15/242,362
• Publication Number:
  US 20160354135A1
• Time in Patent Office: 396 Days
• CPC Class Codes: 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
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00327 Ear, nose or throat
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00714 Temperature
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0268 with restriction of flow
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61N 2007/003 Destruction of nerve tissue
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: A61N 7/022 intracavitary
• CPC Class Codes: G01M 3/24 using infrasonic, sonic, or ultrasonic vibrations
• CPC Class Codes: G01N 2291/0258 : Structural degradation, e.g. fatigue of composites, ageing of oils
• CPC Class Codes: G01N 2291/0289 : Internal structure, e.g. defects, grain size, texture
• CPC Class Codes: G01N 29/043 : in the interior, e.g. by shear waves
• CPC Class Codes: G01N 29/0618 : synchronised with scanning, e.g. in real-time
• CPC Class Codes: G01N 29/07 : by measuring propagation velocity or propagation time of acoustic waves
• CPC Class Codes: G01N 29/225 : Supports, positioning or alignment in moving situation
• CPC Class Codes: G01N 29/262 : by electronic orientation or focusing, e.g. with phased arrays phased arrays per se G10K11/34
• CPC Class Codes: G01N 29/265 : by moving the sensor relative to a stationary material

Abstract

Apparatus and methods for treating conditions such as rhinitis are disclosed herein where a distal end of a probe shaft is introduced through the nasal cavity where the distal end has an end effector with a first configuration having a low-profile which is shaped to manipulate tissue within the nasal cavity. The distal end may be positioned into proximity of a tissue region having a post nasal nerve associated with a middle or inferior nasal turbinate. Once suitably positioned, the distal end may be reconfigured from the first configuration to a second configuration which is shaped to contact and follow the tissue region and the post nasal nerve may then be ablated via the distal end. Ablation may be performed using various mechanisms, such as cryotherapy, and optionally under direct visualization.

Claims

1. A method for treating rhinitis of a patient, the method comprising:

advancing a distal end of a probe through a nasal cavity of a patient, the probe having a probe shaft with a rigid planar member disposed at the distal end of the probe shaft, the rigid planar member formed by a rigid element having an elongate structure with arcuate edges to define an atraumatic surface;

positioning the distal end of the probe so that an expandable structure coupled to the distal end of the probe shaft and surrounding the rigid planar member is positioned in proximity of a lateral nasal wall tissue region of the patient having at least one posterior nasal nerve;

applying lateral pressure against the lateral nasal wall tissue region with the rigid planar member; and

cryogenically ablating the at least one posterior nasal nerve of the lateral nasal wall tissue region by delivering a cryogenic fluid into the expandable structure from a cryogenic fluid source fluidly connected to the expandable structure by a lumen disposed in the probe shaft such that the expandable structure is inflated from a deflated configuration to an expanded configuration in contact against the lateral nasal wall tissue region.

2. The method of claim 1, wherein the positioning of the distal end of the probe comprises manipulating tissue in the nasal cavity of the patient with the rigid planar member.

3. The method of claim 2, wherein the manipulating tissue in the nasal cavity comprises parting tissues of the nasal cavity with the rigid member when the expandable member is in the deflated configuration.

4. The method of claim 1, wherein the positioning of the distal end of the probe comprises positioning the distal end of the probe so that the expandable structure is disposed within a tissue region surrounded by a middle nasal turbinate, the lateral nasal wall, and an inferior nasal turbinate.

5. The method of claim 1, wherein the applying lateral pressure comprises pressing laterally upon a targeted portion of the lateral nasal wall tissue region to compress the lateral nasal wall tissue region to facilitate placement of the distal end of the probe near the at least one posterior nasal nerve.

6. The method of claim 1, wherein the applying lateral pressure comprises pressing against a targeted portion of the lateral nasal wall tissue region with the rigid planar member such that a portion of the expandable structure insulates a non-targeted tissue region in contact with the probe.

7. The method of claim 1, further comprising:

maintaining the expandable structure at the distal end of the probe within the lateral nasal wall tissue region for a predetermined thawing period after the at least one posterior nasal nerve is cryogenically ablated; and

removing the distal end of the probe from the nasal cavity of the patient after the predetermined thawing period.

8. The method of claim 7, wherein the predetermined thawing period is at least 20 seconds.

9. The method of claim 1, wherein the at least one posterior nasal nerve is cryogenically ablated for at least 20 seconds at a temperature of −

20 degrees C. or colder.

10. The method of claim 1, wherein the cryogenically ablating the at least one posterior nasal nerve comprises cooling an external surface of the expandable structure to a temperature between −

20 degrees C. to −

90 degrees C. for less than 120 seconds so as to controllably freeze the at least one posterior nasal nerve at a depth less than 4 mm from a surface of the lateral nasal wall tissue region so as to reduce at least one symptom of rhinitis of the patient.

27. The method of claim 1, wherein the delivering the cryogenic fluid into the expandable structure comprises evaporating the cryogenic fluid within an interior of the expandable structure such that the expandable structure is inflated from the deflated configuration to the expanded configuration.

28. The method of claim 1, wherein the rigid planar member comprises an elongate loop structure and wherein the positioning the distal end of the probe comprises manipulating tissue in the nasal cavity with the elongate loop structure.

29. The method of claim 1, wherein the rigid planar member extends within the expandable structure such that it is unattached to an interior of the expandable structure.

30. The method of claim 1, wherein the expandable structure defines an elongated structure with a first radial axis that is greater than a second radial axis.

11. A method for treating rhinitis of a patient, the method comprising:

advancing a distal end of a probe through a nasal cavity of a patient, the probe having a probe shaft with a planar member disposed at the distal end of the probe shaft, the planar member having an elongate structure with arcuate edges to define an atraumatic surface;

positioning the distal end of the probe so that an expandable structure coupled to the distal end of the probe shaft and surrounding the planar member is positioned in proximity of a lateral nasal wall tissue region of the patient having at least one posterior nasal nerve;

applying lateral pressure against the lateral nasal wall tissue region with the planar member; and

cryogenically ablating the at least one posterior nasal nerve of the lateral nasal wall tissue region by delivering a cryogenic fluid into the expandable structure from a cryogenic fluid source fluidly connected to the expandable structure by a lumen disposed in the probe shaft such that the expandable structure is inflated from a deflated configuration to an expanded configuration in contact against the lateral nasal wall tissue region.

12. The method of claim 11, wherein the delivering the cryogenic fluid into the expandable structure comprises evaporating the cryogenic fluid within an interior of the expandable structure such that the expandable structure is inflated from the deflated configuration to the expanded configuration.

13. The method of claim 11, wherein the planar member comprises an elongate loop structure and wherein the positioning of the distal end of the probe comprises manipulating tissue in the nasal cavity with the elongate loop structure.

14. The method of claim 11, wherein the planar member comprises a rigid wire element and wherein the positioning of the distal end of the probe comprises manipulating tissue in the nasal cavity with the rigid wire element.

15. The method of claim 11, wherein the planar member extends within the expandable structure such that it is unattached to an interior of the expandable structure.

16. The method of claim 11, wherein the expandable structure defines an elongated structure with a first radial axis that is greater than a second radial axis.

17. The method of claim 11, wherein the positioning of the distal end of the probe comprises manipulating tissue in the nasal cavity of the patient with the planar member.

18. The method of claim 17, wherein the manipulating tissue in the nasal cavity comprises parting tissues of the nasal cavity with the planar member when the expandable member is in the deflated configuration.

19. The method of claim 11, wherein the positioning of the distal end of the probe comprises positioning the distal end of the probe so that the expandable structure is disposed within a tissue region surrounded by a middle nasal turbinate, the lateral nasal wall, and an inferior nasal turbinate.

20. The method of claim 11, wherein the applying lateral pressure comprises pressing laterally upon a targeted portion of the lateral nasal wall tissue region to compress the lateral nasal wall tissue region to facilitate placement of the distal end of the probe near the at least one posterior nasal nerve.

21. The method of claim 11, wherein the applying lateral pressure comprises pressing against a targeted portion of the lateral nasal wall tissue region with the planar member such that a portion of the expandable structure insulates a non-targeted tissue region in contact with the probe.

22. The method of claim 11, further comprising:

maintaining the expandable structure at the distal end of the probe within the lateral nasal wall tissue region for a predetermined thawing period after the at least one posterior nasal nerve is cryogenically ablated; and

removing the distal end of the probe from the nasal cavity of the patient after the predetermined thawing period.

23. The method of claim 22, wherein the predetermined thawing period is at least 20 seconds.

24. The method of claim 11, wherein the at least one posterior nasal nerve is cryogenically ablated for at least 20 seconds at a temperature of −

20 degrees C. or colder.

25. The method of claim 11, wherein the cryogenically ablating the at least one posterior nasal nerve comprises cooling an external surface of the expandable structure to a temperature between −

20 degrees C. to −

90 degrees C. for less than 120 seconds so as to controllably freeze the at least one posterior nasal nerve at a depth less than 4 mm from a surface of the lateral nasal wall tissue region so as to reduce at least one symptom of rhinitis of the patient.

26. The method of claim 11, wherein the expandable structure comprises an inflatable balloon.