Apparatus and methods for treating rhinitis

• US 9,687,288 B2
• Filed: 09/30/2014
• Issued: 06/27/2017
• 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:
  US14/503,060
• Publication Number:
  US 20150164571A1
• Time in Patent Office: 1,001 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 a tissue region within a nasal cavity, comprising:

advancing a distal end of a surgical probe shaft through the nasal cavity and into proximity of the tissue region having at least one posterior nasal nerve;

introducing a cryogenic fluid into an expandable structure coupled to the distal end of the probe shaft 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;

adjusting a position of a member relative to the tissue region, wherein the member is disposed at to the distal end of the probe shaft and extends within the expandable structure which encloses the member such that the member is unattached to an interior of the expandable structure;

applying a pressure against the tissue region having the at least one posterior nasal nerve via the member pressing against the interior of the expandable structure, wherein the member defines an atraumatic shape which is sized for pressing against and manipulating the tissue region through the expandable structure; and

maintaining the member against the interior of the expandable structure and the tissue region until the tissue region is cryogenically ablated.

2. The method of claim 1 wherein the maintaining the member further comprises cryogenically ablating the at least one posterior nasal nerve until symptoms of rhinitis are reduced.

3. The method of claim 1 wherein the advancing the distal end comprises advancing the distal end through a nostril and into the nasal cavity.

4. The method of claim 1 wherein the advancing the distal end comprises advancing the distal end at least 2 cm beyond an anterior entrance to a middle meatus.

5. The method of claim 1 wherein the advancing the distal end comprises:

advancing the distal end along an upper surface of the inferior nasal turbinate to a mid-portion of the middle nasal turbinate;

advancing the distal end into a middle meatus; and

further advancing the distal end posteriorly up into a cul-de-sac.

6. The method of claim 1 wherein the advancing the distal end comprises positioning the member between the middle and inferior nasal turbinate.

7. The method of claim 1 wherein the advancing the distal end comprises positioning the member relative to the tissue region surrounded by the middle nasal turbinate, inferior nasal turbinate, and lateral wall forming a cul-de-sac.

8. The method of claim 1 wherein the advancing the distal end comprises positioning the member into proximity of the Pterygomaxillary fossa, sphenopalatine ganglion, sphenopalatine ganglion, or vidian nerve.

9. The method of claim 1 wherein the advancing the distal end comprises positioning the member into proximity of accessory posterolateral nerves bounded by an sphenopalatine foramen superiorly, an inferior edge of an inferior turbinate inferiorly, a Eustachian tube posteriorly, or a posterior third of the middle and inferior turbinates anteriorly.

10. The method of claim 1 wherein the introducing the cryogenic fluid further comprises expanding the expandable structure to a greater extent in one radial axis compared to a second radial axis.

11. The method on claim 1 wherein the adjusting the a position of the member further comprises positioning the member to contact a lateral nasal wall defined by a tail of a nasal turbinate, lateral wall, and an inferior turbinate.

12. The method of claim 1 wherein the introducing the cryogenic fluid further comprises flowing the cryogenic fluid into the interior between approximately 20 seconds to 300 seconds.

13. The method of claim 1 wherein the introducing the cryogenic fluid further comprises flowing the cryogenic fluid into the interior between approximately 20 seconds to 120 seconds.

14. The method of claim 1 wherein the cryogenic fluid comprises nitrous oxide, liquid nitrogen, or carbon dioxide.

15. The method of claim 1 further comprising positioning an imaging device in proximity to the distal end of the surgical probe shaft.

16. The method of claim 1 further comprising visualizing the tissue region while the surgical probe shaft is advanced through the nasal cavity.

17. The method of claim 16 wherein the visualizing is carried out via a CCD or CMOS imager positioned along the surgical probe shaft.

18. The method of claim 16 wherein the visualizing comprises visualizing infrared wavelengths.

19. The method of claim 16 wherein the visualizing is carried out via a nasal endoscope.

20. The method of claim 19 wherein the visualizing comprises advancing the nasal endoscope with the surgical probe shaft.

21. The method of claim 1 further comprising introducing a temperature sensor in proximity to the distal end of the surgical probe shaft.

22. The method of claim 1 wherein the advancing the distal end comprises positioning the surgical probe shaft into proximity of an anterior region of middle or inferior nasal turbinate.

23. The method of claim 1 wherein the applying the a pressure comprises applying a force of 20 to 200 grams via the member pressing against the interior of the expandable structure.

24. The method of claim 1 further comprising stopping the cryogenic fluid and waiting 10 to 20 seconds prior to removing the distal end of the surgical probe shaft from the tissue region.

25. The method of claim 1 wherein the maintaining the member comprises ablating the tissue region through a layer of gel.

26. The method of claim 1 further comprising assessing the tissue region during and/or after ablation.

27. The method of claim 26 wherein the assessing comprises inspecting the tissue region visually or via ultrasound.

28. The method of claim 26 wherein the assessing comprises detecting of a temperature of the tissue region.

29. The method of claim 1 further comprising vibrating the expandable structure while maintaining the member against the interior of the expandable structure and the tissue region.

30. The method of claim 1 further comprising applying an anesthetic to the tissue region to be treated prior to applying a pressure against the tissue region.

31. A method for treating a tissue region within a nasal cavity, comprising:

advancing a distal end of a surgical probe shaft through the nasal cavity and into proximity of the tissue region having at least one posterior nasal nerve;

introducing a cryogenic fluid into an expandable structure coupled to the distal end of the probe shaft such that the expandable structure inflates from a deflated configuration into an expanded configuration against the tissue region, wherein the expandable structure is inflated in response to evaporation of the cryogenic fluid within an interior of the expandable structure;

adjusting a position of a member relative to the tissue region, wherein the member is disposed at the distal end of the probe shaft and extends within the expandable structure which encloses the member such that the member is unattached to the interior of the expandable structure;

applying a pressure against the tissue region having the at least one posterior nasal nerve via the member pressing against the interior of the expandable structure, wherein the member defines an atraumatic shape which is sized for pressing against and manipulating the tissue region through the expandable structure; and

maintaining the member against the interior of the expandable structure and the tissue region until the tissue region is cryogenically ablated.

32. A method for treating rhinitis, comprising:

advancing a distal end of a surgical probe shaft through the nasal cavity and into proximity of a tissue region surrounded by the middle nasal turbinate, inferior nasal turbinate, and lateral wall forming a cul-de-sac and having at least one posterior nasal nerve;

introducing a cryogenic fluid into an expandable structure coupled to the distal end of the probe shaft such that the expandable structure inflates from a deflated configuration into an expanded configuration against the tissue region, wherein the distal end has a member which extends within the expandable structure such that the member is unattached to the interior of the expandable structure, wherein the expandable structure is inflated in response to evaporation of the cryogenic fluid within an interior of the expandable structure;

applying a pressure against the tissue region via the member pressing against the interior of the expandable structure, wherein the member defines an atraumatic shape; and

maintaining the member against the interior of the expandable structure and the tissue region until the tissue region is cryogenically ablated.

33. A method for treating rhinitis, comprising:

advancing a distal end of a surgical probe shaft through the nasal cavity and into proximity of a tissue region surrounded by the middle nasal turbinate, inferior nasal turbinate, and lateral wall forming a cul-de-sac and having at least one posterior nasal nerve;

introducing a cryogenic fluid into an expandable structure coupled to the distal end of the probe shaft such that the expandable structure inflates from a deflated configuration into an expanded configuration against the tissue region, wherein the distal end has a member which extends within the expandable structure such that the member is unattached to the interior of the expandable structure, wherein the cryogenic fluid evaporates within the expandable structure;

applying a pressure against the tissue region via the member pressing against the interior of the expandable structure, wherein the member defines an atraumatic shape and is unattached to the interior of the expandable structure; and

maintaining the member against the interior of the expandable structure and the tissue region until the tissue region is cryogenically ablated.

34. The method of claim 33 wherein the advancing the distal end comprises advancing the distal end at least 2 cm beyond an anterior entrance to a middle meatus.

35. The method of claim 33 wherein the advancing the distal end comprises:

advancing the distal end along an upper surface of the inferior nasal turbinate to a mid-portion of the middle nasal turbinate;

advancing the distal end into a middle meatus; and

further advancing the distal end posteriorly up into a cul-de-sac.

36. The method of claim 33 wherein the advancing the distal end comprises positioning the member between the middle and inferior nasal turbinate.

37. The method of claim 33 wherein the advancing the distal end comprises positioning the member into proximity of the Pterygomaxillary fossa, sphenopalatine ganglion, sphenopalatine ganglion, or vidian nerve.

38. The method of claim 33 wherein the advancing the distal end comprises positioning the member into proximity of accessory posterolateral nerves bounded by an sphenopalatine foramen superiorly, an inferior edge of an inferior turbinate inferiorly, a Eustachian tube posteriorly, or a posterior third of the middle and inferior turbinates anteriorly.

39. The method on claim 33 wherein the advancing the distal end further comprises positioning the member to contact a lateral nasal wall defined by a tail of a nasal turbinate, lateral wall, and an interior turbinate.

40. The method of claim 33 wherein the introducing the cryogenic fluid comprises flowing the cryogenic fluid into the interior between approximately 20 seconds to 300 seconds.

41. The method of claim 33 wherein the introducing the cryogenic fluid further comprises flowing the cryogenic fluid into the interior between approximately 20 seconds to 120 seconds.

42. The method of claim 33 wherein the cryogenic fluid comprises nitrous oxide, liquid nitrogen, or carbon dioxide.

43. The method of claim 33 further comprising positioning an imaging device in proximity to the distal end of the surgical probe shaft.

44. The method of claim 33 further comprising visualizing the tissue region while the surgical probe shaft is advanced through the nasal cavity.

45. The method of claim 44 wherein the visualizing is carried out via a CCD or CMOS imager positioned along the surgical probe shaft.

46. The method of claim 44 wherein the visualizing comprises visualizing infrared wavelengths.

47. The method of claim 44 wherein the visualizing is carried out via a nasal endoscope.

48. The method of claim 47 wherein the visualizing comprises advancing the nasal endoscope with the surgical probe shaft.

49. The method of claim 33 further comprising introducing a temperature sensor in proximity to the distal end of the surgical probe shaft.

50. The method of claim 33 wherein the applying the pressure comprises applying a force of 20 to 200 grams via the member pressing against the interior of the expandable structure.

51. The method of claim 33 further comprising stopping the cryogenic fluid and waiting 10 to 20 seconds prior to removing the distal end of the surgical probe shaft from the tissue region.

52. The method of claim 33 wherein the maintaining the member comprises ablating the tissue region through a layer of gel.

53. The method of claim 33 further comprising assessing the tissue region during and/or after ablation.

54. The method of claim 53 wherein the assessing comprises inspecting the tissue region visually or via ultrasound.

55. The method of claim 53 wherein the assessing comprises detecting a temperature of the tissue region.

56. The method of claim 33 further comprising vibrating the expandable structure while maintaining the member against the interior of the expandable structure and the tissue region.

57. The method of claim 33 further comprising applying an anesthetic to the tissue region to be treated prior to applying a pressure against the tissue region.