Methods and devices to treat nasal airways

• US 10,456,185 B2
• Filed: 06/06/2019
• Issued: 10/29/2019
• 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): Voorhees, Catherine M
• Application Number:
  US16/433,909
• Publication Number:
  US 20190282290A1
• Time in Patent Office: 145 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 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 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/085 Forceps, scissors
• 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 18/1815 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 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 2018/00434 : Neural system
• 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 2018/00648 : using more than one sensed parameter
• 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 2018/00928 : by sending a signal to an external energy source
• 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 2018/044 : the surgical action being effected by a circulating hot 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 2018/1467 : using more than two electrodes on a single probe
• 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 2090/062 : penetration depth
• CPC Class Codes: A61B 2218/007 : Aspiration
• 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: A61B 5/087 : Measuring breath flow
• CPC Class Codes: A61B 5/411 : Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/4836 : Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6819 : Nose
• 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 2007/003 : Destruction of nerve tissue
• 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

A method for reshaping a nasal airway in a patient involves advancing an inflatable balloon of a reshaping device in an uninflated configuration into a nostril of the patient and between a nasal septum and a lateral wall of the nasal airway. The method then involves inflating the inflatable balloon to an inflated configuration to cause the inflatable balloon to contact nasal mucosa covering the nasal septum and the lateral wall, delivering energy from an energy delivery member attached to or inside of the inflatable balloon, and removing the reshaping device from the nasal airway.

Claims

1. A method for treating a nasal airway in a patient, without forming an incision or leaving behind an implant, the method comprising:

advancing a treatment element of a nasal airway treatment device through a nostril of the patient to a nasal valve area of the nasal airway, wherein the treatment element comprises;

a balloon; and

at least one radiofrequency electrode coupled with the balloon;

inflating the balloon to contact nasal mucosa of the nasal airway with the balloon and expand the nasal valve area, without forming an incision;

delivering radiofrequency energy with the at least one radiofrequency electrode to an underlying tissue beneath the nasal mucosa in the nasal valve area, to heat the underlying tissue while maintaining the balloon in an inflated configuration;

deflating the balloon; and

removing the nasal airway treatment device from the nasal airway, without leaving any implant behind in the nasal airway,

wherein expanding the nasal valve area and heating the underlying tissue changes a property of the underlying tissue and causes a diameter of the nasal airway in the nasal valve area to remain at least partially expanded after removal of the nasal airway treatment device and healing of the underlying tissue.

2. The method of claim 1, wherein the treatment element is advanced to a location between a nasal septum and a lateral wall of the nasal airway, wherein inflating the balloon deforms at least one of the nasal septum or the lateral wall, and wherein at least one of the nasal septum or the lateral wall at least partially retains a deformed shape after healing of the nasal septum or the lateral wall.

3. The method of claim 2, wherein the location is between an upper portion of the nasal septum and the lateral wall, and wherein the balloon is inflated until a nasal valve angle of the nasal valve area reaches a desired size.

4. The method of claim 1, wherein inflating the balloon applies sufficient force to a nasal turbinate in the nasal airway to deform and break bone in the nasal turbinate.

5. The method of claim 1, wherein the at least one radiofrequency electrode comprises multiple radiofrequency electrodes attached to an outer surface of the balloon.

6. The method of claim 5, wherein the multiple bipolar radiofrequency electrodes comprise multiple linear bipolar electrode pairs that expand when the balloon expands.

7. The method of claim 1, wherein the underlying tissue comprises nerve fibers, and wherein delivering the radiofrequency energy comprises delivering sufficient energy to damage the nerve fibers.

8. The method of claim 7, wherein the nerve fibers are part of at least one nerve selected from the group consisting of a posterior nasal nerve, an ethmoidal nerve, and a sphenopalatine ganglion.

9. The method of claim 1, wherein the underlying tissue is selected from the group consisting of cartilage and submucosal tissue.

10. The method of claim 1, further comprising determining that the patient suffers from poor nasal airflow, wherein the method improves the patient'"'"'s nasal airflow or the patient'"'"'s perception of nasal airflow.

11. The method of claim 1, further comprising determining that the patient suffers from chronic or allergic rhinitis, wherein the method ameliorates the patient'"'"'s chronic or allergic rhinitis.

12. A method for improving nasal airflow or perceived nasal airflow through a nasal airway in a patient, without forming an incision or leaving behind an implant, the method comprising:

advancing a treatment element of a nasal airway treatment device through a nostril of the patient to a nasal valve area of the nasal airway, wherein the treatment element comprises;

a balloon; and

at least one radiofrequency electrode coupled with the balloon;

inflating the balloon to contact nasal mucosa of the nasal airway with the balloon and expand the nasal valve area without forming an incision;

delivering radiofrequency energy with the at least one radiofrequency electrode to an underlying tissue beneath the nasal mucosa in the nasal valve area, to heat the underlying tissue while maintaining the balloon in an inflated configuration;

deflating the balloon; and

removing the nasal airway treatment device from the nasal airway, without leaving behind any implant,

wherein a property of the underlying tissue in the nasal valve area is changed after removal of the nasal airway treatment device and healing of the nasal tissue.

13. The method of claim 12, wherein the property of the underlying tissue that is changed is selected from the group consisting of size, shape and stiffness.

14. The method of claim 13, wherein the property comprises shape, and wherein the method reshapes the underlying tissue to a concave shape.

15. The method of claim 13, wherein the property comprises stiffness, and wherein the method stiffens the underlying tissue.

16. The method of claim 12, wherein delivering the radiofrequency energy comprises delivering sufficient energy to damage nerve fibers underlying the nasal mucosa of the nasal airway.

17. The method of claim 12, wherein the underlying tissue is selected from the group consisting of the cartilage and submucosal tissue.

18. The method of claim 12, further comprising determining that the patient suffers from chronic or allergic rhinitis, wherein the method ameliorates the patient'"'"'s chronic or allergic rhinitis.