Apparatus and method for treating rhinitis

• US 9,763,743 B2
• Filed: 07/24/2015
• Issued: 09/19/2017
• Est. Priority Date: 07/25/2014
• Status: Active Grant

• Current Assignee: Arrinex, Inc. (Stryker Corporation)
• Original Assignee: Arrinex, Inc. (Stryker Corporation)
• Inventors: Lin, Bryant, Moosavi, David, Saadat, Mojgan, Saadat, Vahid
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): VAHDAT, KHADIJEH A
• Application Number:
  US14/808,690
• Publication Number:
  US 20160045277A1
• Time in Patent Office: 788 Days
• Field of Search: 606 21- 27
• 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 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 2017/00075 Motion
• CPC Class Codes: A61B 2017/00106 ultrasonic
• 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 2018/00863 Fluid flow
• 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 2018/207 mixing two wavelengths
• CPC Class Codes: A61B 2018/2211 Plurality of fibres
• CPC Class Codes: A61B 2034/2046 Tracking techniques
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/3612 with images taken automatically
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61B 2090/363 Use of fiducial points
• CPC Class Codes: A61B 2090/3945 : Active visible markers, e.g. light emitting diodes
• CPC Class Codes: A61B 34/20 : Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 90/06 : Measuring instruments not otherwise provided for
• CPC Class Codes: A61B 90/30 : Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

Devices and methods for treating rhinitis are described where the devices are configured to ablate a single nerve branch or multiple nerve branches of the posterior nasal nerves located within the nasal cavity. A surgical probe may be inserted into the sub-mucosal space of a lateral nasal wall and advanced towards a posterior nasal nerve associated with a middle nasal turbinate or an inferior nasal turbinate into a position proximate to the posterior nasal nerve where neuroablation of the posterior nasal nerve may be performed with the surgical probe. The probe device may utilize a visible light beacon that provides trans-illumination of the sub-mucosal tissue or an expandable structure disposed in the vicinity of the distal end of the probe shaft to enable the surgeon to visualize the sub-mucosal position of the distal end of the surgical probe from inside the nasal cavity using, e.g., an endoscope.

Claims

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

visualizing a tissue region of a lateral nasal wall located within a nasal cavity of the patient;

inserting a distal end of a surgical probe into a sub-mucosal space of the lateral nasal wall of the patient, the surgical probe comprising a surgical probe shaft with a proximal end and the distal end, a handle coupled to the proximal end, a cryo-ablation element disposed on the distal end, and a position indicator disposed in the vicinity of the distal end;

advancing the distal end of the surgical probe shaft within the lateral nasal wall tissue region and towards at least one posterior nasal nerve associated with the lateral nasal wall tissue region while visually tracking a position of the distal end with the position indicator; and

cryogenically ablating the at least one posterior nasal nerve with the cryo-ablation element to reduce at least one symptom of rhinitis.

2. The method of claim 1 further comprising detecting or quantifying an arterial blood flow within the lateral nasal wall region with a sensor prior to ablating the at least one posterior nasal nerve.

3. The method of claim 2 wherein the sensor comprises an ultrasonic or optical sensor.

4. The method of claim 1 wherein cryogenically ablating the at least one posterior nasal nerve comprises delivering a cryogenic fluid into the cryo-ablation element from a cryogenic fluid source fluidly connected to the cryo-ablation element.

5. The method of claim 4 wherein the cryo-ablation element comprises an expandable membranous structure such that the expandable structure is inflated from a deflated configuration to an expanded configuration in contact against the tissue region of the lateral nasal wall.

6. The method of claim 1 wherein cryogenically ablating the at least one posterior nasal nerve comprises freezing via a Joule-Thompson gas expansion mechanism.

7. The method of claim 1 wherein the distal end of the surgical probe is inserted into the sub-mucosal space at a position substantially anterior to a middle nasal turbinate or an inferior nasal turbinate of the patient.

8. The method of claim 1 wherein the distal end of the surgical probe is inserted into the sub-mucosal space substantially in between a middle nasal turbinate and an inferior nasal turbinate of the patient.

9. The method of claim 1 wherein the distal end of the surgical probe is inserted into the sub-mucosal space in a vicinity of a cul de sac defined by a tail of a middle nasal turbinate, lateral nasal wall, and inferior nasal turbinate of the patient.

10. The method of claim 1 wherein inserting the distal end of the surgical probe comprises advancing the distal end of the probe shaft to a position proximate of the at least one posterior nasal nerve along a surgical plane defined by a bone of the lateral nasal wall and a nasal mucosa.

11. The method of claim 1 wherein inserting the distal end of the surgical probe comprises advancing the distal end of the probe shaft to a position proximate to the at least one posterior nasal nerve while avoiding damage to arteries, veins, and non-target nerves.

12. The method of claim 1 further comprising protecting a superficial mucosal tissue from injury while cryogenically ablating at least one posterior nasal nerve.

13. The method of claim 12 wherein protecting the superficial mucosal tissue comprises warming the superficial mucosal tissue.

14. The method of claim 1 wherein cryogenically ablating at least one posterior nasal nerve comprises ablating a surrounding region of tissue to a depth of 50-1000 microns.

15. The method of claim 1, wherein the position indicator comprises an optical beacon, and wherein visually tracking the position of the distal end of the probe shaft comprises trans-illuminating the optical beacon through mucosa.

16. The method of claim 15, wherein the optical beacon is configured to emit light having a wavelength suitable for optical absorption by hemoglobin.

17. The method of claim 15, wherein the optical beacon is configured to emit light having a wavelength in a visible light spectrum.

18. The method of claim 17, wherein the optical beacon is configured to emit light having a wavelength substantially in a green segment of the visible light spectrum.

19. The method of claim 15, further comprising adjusting a brightness of the optical beacon prior to cryogenically ablating at least one posterior nasal nerve.

20. The method of claim 1, wherein the position indicator comprises an expandable structure, and wherein visually tracking the position of the distal end of the probe comprises expanding the expandable structure so as to displace mucosal tissue overlying the distal end of the probe.

21. The method of claim 20, wherein the cryo-ablation element comprises the expandable structure.

22. The method of claim 21, wherein cryogenically ablating the at least one posterior nasal nerve comprises introducing liquid cryogen into the expandable structure so as to cryogenically ablate the at least one posterior nasal nerve.

23. The method of claim 20, wherein visually tracking the position of the distal end of the probe comprises endoscopically visualizing a displacement of mucosal tissue overlying the distal end of the probe.