Methods and devices to treat nasal airways

• US 9,486,278 B2
• Filed: 11/13/2014
• Issued: 11/08/2016
• 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
• Primary Examiner(s): Manuel, Goerge
• Application Number:
  US14/540,050
• Publication Number:
  US 20150073395A1
• Time in Patent Office: 726 Days
• US Class Current: 1/1
• 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 modifying a property of nasal tissue of or near a nasal valve, without using a surgical incision or an implant, to decrease airflow resistance or perceived airflow resistance in a nasal airway, the method comprising:

positioning a treatment surface within a nasal airway adjacent to a nasal tissue to be treated;

applying the treatment surface to the nasal tissue with sufficient force to alter a shape of the nasal tissue; and

applying energy to, or removing energy from, the nasal tissue with a non-penetrating treatment element disposed on the treatment surface, to change the property of the nasal tissue, wherein the nasal tissue at least partially maintains the changed property after the treatment element is removed and the nasal tissue heals, thereby decreasing airflow resistance or perceived airflow resistance in the nasal airway.

2. The method of claim 1, wherein applying energy comprises applying energy in a form selected from the group consisting of ultrasound, microwave, heat, radiofrequency, electrical, light and laser.

3. The method of claim 1, wherein removing energy comprises applying cryotherapy to the nasal tissue, and wherein the treatment element comprises a cryotherapy delivery member.

4. The method of claim 1, wherein applying energy comprises injuring the nasal tissue.

5. The method of claim 1, further comprising, before applying energy to, or removing energy from, the nasal tissue, injecting a polymerizing liquid into or below the nasal tissue.

6. The method of claim 1, comprising both applying energy to and removing energy from the nasal tissue with the treatment element.

7. The method of claim 6, wherein applying and removing the energy is performed in a cyclical fashion to repeatedly heat and cool the nasal tissue.

8. The method of claim 1, wherein the property is a mechanical property of the nasal tissue.

9. The method of claim 1, wherein the property is a property of extracellular matrix components of the nasal tissue and the method does not damage chondrocytes of the nasal tissue.

10. The method of claim 1, wherein the property of the tissue is the strength of the nasal tissue to resist a conformational change in response to negative pressure of inspiration.

11. The method of claim 1, further comprising cooling the nasal tissue or tissue near the nasal tissue to be treated before, during, or after applying energy.

12. The method of claim 1, wherein applying the treatment surface to the nasal tissue and applying the energy modifies a mechanical property of the nasal tissue in a manner that increases a volumetric airflow rate of air flowing from an exterior of the nasal airway into a nasopharynx without changing a shape of an internal nasal valve.

13. The method of claim 1, further comprising delivering a cauterizing agent to the nasal tissue.

14. A method of treating a patient'"'"'s nasal airway by modifying a property of nasal tissue, the method comprising:

positioning a treatment element within a nasal airway adjacent to nasal tissue to be treated, wherein the treatment element comprises a convex treatment surface;

deforming the nasal tissue into a concave shape by pressing the convex treatment surface of the treatment element against the nasal tissue to be treated; and

delivering energy to, or removing energy from, the nasal tissue to modify a property of the nasal tissue without ablating the tissue, wherein the nasal tissue at least partially maintains the modified property after the treatment element is removed and the nasal tissue heals.

15. The method of claim 14, wherein delivering energy to the nasal tissue comprises delivering energy to at least one of the nasal valve, tissue near the nasal valve, or upper lateral cartilage tissue.

16. The method of claim 14, further comprising cooling the nasal tissue to be treated or tissue near the nasal tissue to be treated before, during, or after delivering energy to the nasal tissue.

17. The method of claim 14, wherein delivering energy to, or removing energy from, the nasal tissue comprises:

measuring a temperature near the nasal tissue; and

adjusting a level of the energy delivered to, or removed from, the tissue, based on the measured temperature.

18. The method of claim 14, further comprising, before positioning the treatment element, inserting a positioning element into the nasal airway to determine a position for positioning the treatment element.

19. The method of claim 14, wherein delivering energy to or removing energy from the nasal tissue comprises delivering or removing energy for about 15 seconds to about 1 minute.

20. The method of claim 14, wherein delivering energy to the nasal tissue comprises heating the tissue to a temperature of about 50°

C. to about 70°

C.

21. The method of claim 14, wherein deforming the nasal tissue and delivering or removing energy causes stress relaxation in the nasal tissue without weakening the tissue.

22. The method of claim 14, wherein delivering energy comprises delivering energy in a form selected from the group consisting of ultrasound, microwave, heat, radiofrequency, electrical, light and laser.

23. The method of claim 14, wherein removing energy comprises applying cryotherapy to the nasal tissue, and wherein the treatment element comprises a cryotherapy delivery member.

24. A method of modifying a property of nasal tissue of or near a nasal valve, without using a surgical incision or an implant, to decrease airflow resistance or perceived airflow resistance in a nasal airway, the method comprising:

positioning a treatment surface of an airway treatment device within a nasal airway adjacent to a nasal tissue to be treated;

injecting a polymerizing liquid into or below the nasal tissue, before or after positioning the treatment surface;

applying the treatment surface to the nasal tissue with sufficient force to alter a shape of the nasal tissue; and

applying energy to, or removing energy from, the nasal tissue with the treatment element, to change the property of the nasal tissue.