Methods and devices to treat nasal airways

• US 8,986,301 B2
• Filed: 09/13/2013
• Issued: 03/24/2015
• Est. Priority Date: 06/13/2012
• Status: Active Grant

• Current Assignee: Aerin Medical Inc.
• Original Assignee: Aerin Medical Inc.
• Inventors: Wolf, Scott J., Frazier, Andrew
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/026,922
• Publication Number:
  US 20140088463A1
• Time in Patent Office: 557 Days
• Field of Search: 606/41, 607/135
• US Class Current: 606/41
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 18/1206 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 18/1477 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 2017/248 Operations for treatment of snoring, e.g. uvulopalatoplasty
• 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 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00821 : measured by a thermocouple
• CPC Class Codes: A61B 2018/00886 : Duration
• CPC Class Codes: A61B 2018/00922 : by switching or controlling the treatment energy directly within the hand-piece
• CPC Class Codes: A61B 2018/0212 : using an instrument inserted into a body lumen, e.g. catheter
• 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: 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 1/403 : 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

Abstract

A method is described for modifying at least one property of a tissue of or near 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 may involve contacting a treatment element of a treatment device with the at least one tissue inside the nasal airway, with sufficient force to at least temporarily deform the at least one tissue, applying energy to, or removing energy from, the at least one tissue, using the treatment element, and removing the treatment element from the nostril.

Claims

1. A method of modifying at least one property of at least one tissue of or near 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 an elongate treatment element of a treatment device with the at least one tissue inside the nasal airway, with sufficient force to at least temporarily deform the at least one tissue;

applying energy to the at least one tissue by transmitting radio frequency energy from a first row of electrodes to a second row of electrodes disposed vertically on the elongate treatment element; and

removing the elongate treatment element from the nostril.

2. A method as in claim 1, wherein the elongate treatment element has a convex shape, such that contacting the treatment element against the at least one tissue at least temporarily deforms the tissue into a concave shape.

3. A method as in claim 2, wherein contacting the elongate treatment element with the tissue causes at least one protrusion on the treatment element to deform the tissue.

4. A method as in claim 1, wherein applying energy further comprises applying energy in a form selected from the group consisting of ultrasound, microwave, heat, electrical, light and laser.

5. A method as in claim 4, wherein applying energy comprises delivering radiofrequency energy to one or more electrodes of the elongate treatment element to locally heat the at least one tissue, wherein delivering radiofrequency energy while deforming the at least one tissue causes the tissue to change shape.

6. A method as in claim 1, wherein the at least one tissue comprises nasal valve tissue.

7. A method as in claim 1, wherein the at least one tissue comprises nasal mucosa at or near a junction of a pyriform aperture and a lower lateral cartilage.

8. A method as in claim 1, wherein the at least one tissue comprises upper lateral cartilage.

9. A method as in claim 1, further comprising removing energy from the at least one tissue using cryogenic therapy provided by the elongate treatment element.

10. A method as in claim 1, wherein the energy is applied to or removed from the at least one tissue while the at least one tissue is deformed.

11. A method as in claim 1, wherein the energy applied by the elongate treatment element is generated from a power source within the treatment device.

12. A method as in claim 1, further comprising injecting a substance into the at least one tissue prior to applying the energy, wherein the applied energy affects the injected substance to help modify the property of the tissue.

13. A method as in claim 1, further comprising applying a substance to the at least one tissue or to an outer surface of the nose before applying the energy.

14. A method as in claim 1, wherein the at least one property of the at least one tissue is modified without reshaping the at least one tissue.

15. A method as in claim 1, wherein modifying the at least one property comprises stiffening the at least one tissue, with or without reshaping it.

16. A method as in claim 1, wherein the at least one tissue is selected from the group consisting of epithelium, cartilage, mucosa, sub-mucosa, muscle, ligament, tendon and skin.

17. A method as in claim 1, further comprising cooling the at least one tissue and/or other tissues in or on the nose, before, during, or after applying the energy.

18. A method as in claim 1, further comprising:

measuring at least one parameter at or near the at least one tissue to be treated; and

adjusting a level of energy application or removal, based on the measured parameter.

19. A method as in claim 18, wherein the at least one parameter is selected from the group consisting of temperature and impedance.

20. A device for treating a patient'"'"'s nasal airway by modifying at least one property of at least one tissue of or near a nasal valve of the airway, without using a surgical incision or an implant, to decrease airflow resistance or perceived airflow resistance in a nasal airway, the device comprising:

an energy delivery member sized to be inserted into a nose and configured to deliver energy to tissues within the nose to modify the at least one property of the at least one tissue;

comprising multiple protruding electrodes configured to at least temporarily deform nasal tissue;

a shaft extending from the energy delivery member; and

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

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.

21. A device as in claim 20, wherein the energy delivery member has a contact surface with convex shape configured to at least temporarily create a concavity in nasal tissue.

22. A device as in claim 20, wherein the energy delivery member has a contact surface with flat shape.

23. A device as in claim 20, wherein the housing is configured to hold at least one battery.

24. A device as in claim 20, further comprising at least one sensor configured to sense at least one of temperature or impedance in nasal tissue.

25. A device as in claim 24, wherein the at least one sensor is attached to the device on or near the energy delivery member.

26. A device as in claim 20, further comprising a tissue cooling member attached to the device at or near the energy delivery member.