Apparatus and methods for treating rhinitis

• US 10,028,781 B2
• Filed: 08/31/2017
• Issued: 07/24/2018
• 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:
  US15/693,216
• Publication Number:
  US 20170360494A1
• Time in Patent Office: 327 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 cryogenic probe for treating rhinitis, the probe comprising:

a probe shaft having a distal end and a proximal end;

a planar member defining a flattened shape disposed at the distal end of the probe shaft, the planar member having an elongate structure with arcuate edges to define an atraumatic surface when the distal end of the probe shaft is advanced through a nasal cavity of a patient and positioned within a lateral nasal wall tissue region having at least one nasal nerve associated with a middle or inferior nasal turbinate, wherein the planar member is configured to transmit lateral pressure against the nasal wall tissue region;

an expandable structure surrounding the planar member and coupled to the distal end of the probe shaft, wherein the expandable structure is inflatable from a deflated configuration to an expanded configuration;

a cryogenic fluid source coupled to the proximal end of the probe shaft; and

a lumen disposed in the probe shaft and in fluid communication with the cryogenic fluid source and an interior of the expandable structure, wherein the cryogenic probe is configured to cryogenically ablate the at least one nasal nerve when cryogenic fluid from the cryogenic fluid source is introduced into the interior of the expandable structure via the lumen and the expandable structure in the expanded configuration is in contact against the lateral nasal wall tissue region.

2. The cryogenic probe of claim 1, wherein the expandable structure is configured to expand to a predetermined shape and size in the expanded configuration, wherein the predetermined shape and size corresponds to a shape and size of the lateral nasal wall tissue region.

3. The cryogenic probe of claim 1, wherein the expandable structure is configured to transition from the deflated configuration to the expanded configuration upon evaporation of cryogenic fluid within an interior of the expandable structure.

4. The cryogenic probe of claim 1, wherein the planar member is formed by a rigid element into the elongate structure, wherein the planar member comprises an elongate loop structure formed by a rigid wire that is configured to manipulate tissue in the nasal cavity.

5. The cryogenic probe of claim 1, wherein the expandable structure defines an elongate structure with a major axial dimension in a range from 8 mm to 16 mm.

6. The cryogenic probe of claim 1, wherein the planar member extends within the expandable structure such that it is unattached to an interior of the expandable structure.

7. The cryogenic probe of claim 1, wherein the probe is configured to cool an external surface of the expandable structure to between −

20 degrees C. to −

90 degrees C. for less than 120 seconds so as to controllably freeze the at least one 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.

8. The cryogenic probe of claim 1, wherein the expandable structure is configured to maintain its expanded configuration when the planar member transmits lateral pressure against a targeted portion of the nasal wall tissue region so as to insulate a non-targeted tissue region in contact with the probe, wherein the expanded configuration is asymmetrical so as to insulate the non-targeted portion tissue region.

9. The cryogenic probe of claim 1, further comprising a Doppler flow sensor coupled to the distal end of the probe shaft and configured to identify an artery associated with the at least one nasal nerve.

10. The cryogenic probe of claim 9, wherein the Doppler flow sensor comprises an ultrasound detector.

11. The cryogenic probe of claim 9, wherein the Doppler flow sensor comprises an optical detector.

12. The cryogenic probe of claim 9, wherein the artery associated with the at least one nasal nerve comprises an artery from a sphenopalatine branch.

13. The cryogenic probe of claim 1, wherein the at least one nasal nerve comprises a posterior nasal nerve of a nasal branch of a vidian nerve.

14. The cryogenic probe of claim 1, wherein the at least one nasal nerve comprises a parasympathetic nerve.

15. The cryogenic probe of claim 1, wherein the distal end of the probe shaft is advanced through a nasal cavity of a patient and in proximity of a sphenopalatine foramen.

16. The cryogenic probe of claim 1, wherein the probe shaft has a curved distal portion.

17. A cryogenic system for treating rhinitis, the system comprising the cryogenic probe of claim 1 and an imaging device in proximity to the distal end of the probe shaft.

18. The cryogenic system of claim 17, wherein the imaging device comprises a nasal endoscope.

19. A cryogenic probe for treating rhinitis, the probe comprising:

a probe shaft having a distal end and a proximal end;

a planar member defining a flattened shape disposed at the distal end of the probe shaft, the planar member having an elongate structure with arcuate edges to define an atraumatic surface when the distal end of the probe shaft is advanced through a nasal cavity of a patient and positioned within a lateral nasal wall tissue region having at least one nasal nerve associated with a middle or inferior nasal turbinate, wherein the planar member is configured to contact the lateral nasal wall tissue region;

an expandable balloon surrounding the planar member and coupled to the distal end of the probe shaft, wherein the expandable balloon is inflatable from a deflated configuration to an expanded configuration;

a cryogenic fluid source coupled to the proximal end of the probe shaft; and

a lumen disposed in the probe shaft and in fluid communication with the cryogenic fluid source and an interior of the expandable balloon, wherein the cryogenic probe is configured to cryogenically ablate the at least one nasal nerve when cryogenic fluid from the cryogenic fluid source is introduced into the interior of the expandable balloon via the lumen and the expandable balloon in the expanded configuration is in contact against the lateral nasal wall tissue region.

20. The cryogenic probe of claim 19, wherein the planar member is formed by a rigid element into the elongate structure, wherein the planar member comprises an elongate loop structure formed by a rigid wire that is configured to transmit lateral pressure against the nasal wall tissue region or manipulate tissue in the nasal cavity.

21. The cryogenic probe of claim 19, wherein the planar member extends within the expandable balloon such that it is unattached to an interior of the expandable balloon.

22. The cryogenic probe of claim 19, wherein the probe is configured to cool an external surface of the expandable balloon to between −

20 degrees C. to −

90 degrees C. for less than 120 seconds so as to controllably freeze the at least one 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.

23. The cryogenic probe of claim 19, further comprising a Doppler flow sensor coupled to the distal end of the probe shaft and configured to identify an artery associated with the at least one nasal nerve.

24. The cryogenic probe of claim 23, wherein the Doppler flow sensor comprises an ultrasound detector.

25. The cryogenic probe of claim 23, wherein the artery associated with the at least one nasal nerve comprises an artery from a sphenopalatine branch.

26. The cryogenic probe of claim 19, wherein the at least one nasal nerve comprises a posterior nasal nerve of a nasal branch of a vidian nerve.

27. The cryogenic probe of claim 19, wherein the at least one nasal nerve comprises a parasympathetic nerve.

28. The cryogenic probe of claim 19, wherein the distal end of the probe shaft is advanced through a nasal cavity of a patient and in proximity of a sphenopalatine foramen.

29. The cryogenic probe of claim 19, wherein the probe shaft has a curved distal portion.

30. A cryogenic system for treating rhinitis, the system comprising the cryogenic probe of claim 19 and an imaging device in proximity to the distal end of the probe shaft.