METHODS AND DEVICES TO TREAT NASAL AIRWAYS

• US 20140316396A1
• Filed: 06/30/2014
• Published: 10/23/2014
• Est. Priority Date: 06/14/2011
• Status: Active Grant

• Current Assignee: Aerin Medical Inc.
• Original Assignee: Aerin Medical Inc.
• Inventors: WOLF, Scott J., Frazier, Andrew
• Granted Patent: US 9,072,597 B2
• Time in Patent Office: Days
• US Class Current: 606/14
• CPC Class Codes: A61B 17/2816 Pivots
• CPC Class Codes: A61B 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• 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 18/06 caused by chemical reaction , e.g. moxaburners
• CPC Class Codes: A61B 18/085 Forceps, scissors
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• CPC Class Codes: A61B 18/1445 at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/248 Operations for treatment of snoring, e.g. uvulopalatoplasty
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2017/32007 with suction or vacuum means
• CPC Class Codes: A61B 2018/00005 Cooling or heating of the probe or tissue immediately surrounding the probe
• CPC Class Codes: A61B 2018/00023 : closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/0016 : Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00178 : Electrical connectors
• CPC Class Codes: A61B 2018/0022 : Balloons
• CPC Class Codes: A61B 2018/00327 : Ear, nose or throat
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/00595 : Cauterization
• CPC Class Codes: A61B 2018/00642 : with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00708 : switching the power on or off
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00821 : measured by a thermocouple
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00886 : Duration
• CPC Class Codes: A61B 2018/0091 : Handpieces of the surgical instrument or device
• CPC Class Codes: A61B 2018/00922 : by switching or controlling the treatment energy directly within the hand-piece
• 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 2018/00994 : combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• CPC Class Codes: A61B 2018/0212 : using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0225 : using an instrument for clamping tissue, e.g. forceps
• CPC Class Codes: A61B 2018/0262 : using a circulating cryogenic fluid
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/143 : multiple needles
• CPC Class Codes: A61B 2018/1807 : using light other than laser radiation
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 5/01 : Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61F 5/08 : Devices for correcting deformities of the nose ; Devices for enlarging the nostril, e.g. for breathing improvement
• CPC Class Codes: A61F 5/56 : Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00
• CPC Class Codes: A61F 7/10 : Cooling bags, e.g. ice-bags
• CPC Class Codes: A61N 1/40 : Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 5/025 : Warming the body, e.g. hyperthermia treatment
• CPC Class Codes: A61N 5/0603 : for treatment of body cavities
• CPC Class Codes: A61N 5/0625 : Warming the body, e.g. hyperthermia treatment
• CPC Class Codes: A61N 7/022 : intracavitary
• CPC Class Codes: F04C 2270/041 : Controlled or regulated

Abstract

Methods and devices for treating nasal airways are provided. Such devices and methods may improve airflow through an internal and/or external nasal valve, and comprise the use of mechanical re-shaping, energy application and other treatments to modify the shape, structure, and/or air flow characteristics of an internal nasal valve, an external nasal valve or other nasal airways.

Claims

1. A method of treating a patient'"'"'s nasal airway, the method comprising:

advancing a treatment element of a treatment device into an incision in mucosal tissue of the nasal airway to contact submucosal tissue of the nasal airway;

delivering an energy based therapy to the submucosal tissue through the treatment element to at least one of reshape, remodel, strengthen or change a property of the submucosal tissue; and

removing the treatment element from the nasal airway.

2. A method as in claim 1, further comprising forming the incision in the mucosal tissue, using the treatment device.

3. A method as in claim 2, wherein forming the incision comprises cutting the mucosal tissue with a cutting edge of the treatment device.

4. A method as in claim 1, wherein delivering the energy based therapy comprises delivering energy to the submucosal tissue in a form selected from the group consisting of ultrasound, microwave, heat, radiofrequency, electrical, light, laser and quantic molecular resonance.

5. A method as in claim 1, wherein delivering the energy based therapy comprises delivering cryotherapy to the submucosal tissue.

6. A method as in claim 1, wherein the submucosal tissue includes tissue selected from the group consisting of upper lateral cartilage, lower lateral cartilage, nasal septum within the nasal valve, nasal septum outside of the nasal valve, swell bodies located on a nasal septum, a septal turbinate, a high deviated nasal septum, a nasal scroll, a floor of the nasal cavity, a piriform area, and swell bodies on a floor of the nasal cavity.

7. A method as in claim 1, further comprising applying force to the submucosal tissue with the treatment element at least one of before, during or after delivering the energy based therapy to deform the submucosal tissue.

8. A method as in claim 7, wherein a tissue contacting surface of the treatment element has a shape selected from the group consisting of convex, concave and flat.

9. A method of treating a patient'"'"'s nasal airway, the method comprising:

adjusting a shape of a nasal airway treatment device;

contacting a treatment element of the treatment device with mucosal tissue in the patient'"'"'s nasal airway;

delivering an energy based therapy to at least one of the mucosal tissue or an underlying tissue beneath the mucosal tissue, using the treatment element; and

removing the treatment element from the nasal airway.

10. A method as in claim 9, wherein adjusting the shape comprises shaping the treatment element to have a convex treatment surface.

11. A method as in claim 9, wherein adjusting the shape comprises shaping the treatment element to have a concave treatment surface.

12. A method as in claim 9, wherein adjusting the shape comprises adjusting a height of at least one electrode on a treatment surface of the treatment element.

13. A method as in claim 12, wherein adjusting the height comprises adjusting multiple heights of multiple electrodes to form a treatment surface profile.

14. A method as in claim 9, wherein adjusting the shape comprises manipulating a secondary component of the treatment element to increase a surface area of the treatment element.

15. A method as in claim 9, wherein adjusting the shape comprises inflating the treatment element to increase a surface area of the treatment element.

16. A method as in claim 9, wherein adjusting the shape comprises forming at least one bend in a shaft of the treatment device.

17. A method as in claim 9, wherein adjusting the shape comprises rotating the treatment element relative to a shaft of the treatment device.

18. A method as in claim 9, wherein delivering the energy based therapy comprises delivering energy in a form selected from the group consisting of ultrasound, microwave, heat, radiofrequency, electrical, light, laser and quantic molecular resonance.

19. A method as in claim 9, wherein delivering the energy based therapy comprises delivering cryotherapy.

20. A method as in claim 9, wherein the mucosal tissue is located in a part of the nasal airway other than an internal nasal valve of the airway.

21. A method as in claim 20, further comprising:

contacting the treatment element with other mucosal tissue at an additional location in the nasal airway, wherein the additional location is part of the nasal valve; and

delivering the energy based therapy to at least one of the other mucosal tissue or an underlying tissue beneath the other mucosal tissue at the additional location.

22. A method as in claim 20, wherein the wherein mucosal tissue includes tissue selected from the group consisting of upper lateral cartilage, lower lateral cartilage, nasal septum within the nasal valve, nasal septum outside of the nasal valve, swell bodies located on a nasal septum, a septal turbinate, a high deviated nasal septum, a nasal scroll, a floor of the nasal cavity, a piriform area, and swell bodies on a floor of the nasal cavity.

23. A method as in claim 9, further comprising applying force to the mucosal tissue with the treatment element at least one of before, during or after delivering the energy based therapy to deform the mucosal tissue.

24. A method as in claim 9, wherein delivering the energy based therapy modifies at least one property of the mucosal tissue or the underlying tissue without reshaping the tissue.

25. A method as in claim 9, wherein the underlying tissue is selected from the group consisting of cartilage, submucosa, muscle, ligament and tendon.

26. A method as in claim 9, further comprising cooling at least one of the mucosal tissue or another tissue in the nasal airway.

27. A method of treating a nasal valve of a nose, without using a surgical incision or an implant, to decrease airflow resistance or perceived airflow resistance in a nasal airway, the method comprising:

contacting a treatment element of the treatment device with mucosal tissue in the patient'"'"'s nasal airway;

delivering an energy based therapy to at least one of the mucosal tissue or an underlying tissue beneath the mucosal tissue, using the treatment element;

sensing at least one temperature of at least one of the mucosal tissue or the underlying tissue, using a sensing element on the treatment device;

adjusting the delivery of the energy based therapy, based on the at least one temperature; and

removing the treatment element from the nasal airway.

28. A method as in claim 27, wherein sensing the at least one temperature comprises sensing multiple temperatures with multiple thermocouples located at or near multiple electrode pairs on the treatment element, wherein each of the multiple thermocouples is located at or near one of the multiple electrode pairs.

29. A method as in claim 28, further comprising determining an average temperature of at least two of the multiple temperatures, wherein the delivery of the energy based therapy is adjusted based on the average temperature.

30. A method as in claim 28, wherein adjusting the delivery comprises adjusting delivery to at least one of the electrode pairs separately from at least one other of the electrode pairs.

31. A device for modifying at least one property of at least one tissue in a nasal airway, the device comprising:

a head portion configured for passing through an incision in mucosal tissue to a location between the mucosal tissue and submucosal tissue, the head portion comprising;

an energy based therapy delivery member; and

an incision forming member;

a shaft extending from the head portion; and

a handle attached to the shaft at an opposite end from the head portion, wherein the handle includes a housing to hold a power source for providing energy to the energy delivery member.

32. A device as in claim 31, wherein the energy delivery member has a contact surface with a convex shape configured to at least temporarily create a concavity in the at least one tissue.

33. A device as in claim 31, wherein the energy delivery member has a contact surface with flat shape.

34. A device as in claim 31, wherein the energy delivery member comprises multiple flexible sections configured to be manipulated.

35. A device as in claim 34, wherein the flexible sections comprise multiple protruding electrodes configured to at least temporarily deform nasal tissue.

36. A device as in claim 35, wherein the protruding electrodes comprise two rows of electrodes, wherein the energy delivery member comprises a bipolar radio frequency delivery member, and wherein radio frequency energy travels from one row of electrodes to the other row of electrodes.

37. A device as in claim 31, wherein the housing is configured to hold at least one battery.

38. A device as in claim 31, further comprising at least one sensor configured to sense at least one of temperature or impedance in nasal tissue.

39. A device as in claim 38, wherein the at least one sensor is attached to the device on or near the energy delivery member.

40. A device as in claim 31, further comprising a tissue cooling member attached to the device at or near the energy delivery member.

41. A device as in claim 31, wherein the energy delivery member comprises at least one electrode pair configured to apply energy to the at least one tissue.

42. A device as in claim 41, further comprising at least one thermocouple configured to sense temperature at each electrode pair.

43. A method as in claim 42, further comprising a processor to determine an average temperature from multiple temperatures sensed by more than one of the at least one thermocouple.

44. A method as in claim 41, wherein each of the at least one electrode pair is adjustable separately from adjustment of any other of the at least one electrode pair.

45. A method of treating a patient'"'"'s nasal airway, the method comprising:

contacting a treatment element of the treatment device with a first mucosal tissue located in a part of the nasal airway other than an internal nasal valve of the airway;

delivering an energy based therapy to at least one of the first mucosal tissue or an underlying tissue beneath the first mucosal tissue, using the treatment element; and

removing the treatment element from the nasal airway.

46. A method as in claim 45, further comprising:

contacting the treatment element with a second mucosal tissue at an additional location that is part of the nasal valve; and

delivering the energy based therapy to at least one of the second mucosal tissue or an underlying tissue beneath the second mucosal tissue at the additional location.

47. A method as in claim 45, wherein the wherein mucosal tissue includes tissue selected from the group consisting of upper lateral cartilage, lower lateral cartilage, nasal septum outside of the nasal valve, swell bodies located on a nasal septum, a septal turbinate, a high deviated nasal septum, a nasal scroll, a floor of the nasal cavity, a piriform area, and swell bodies on a floor of the nasal cavity.