Methods and devices to treat nasal airways

• US 9,788,886 B2
• Filed: 09/21/2016
• Issued: 10/17/2017
• 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, GEORGE C
• Application Number:
  US15/272,007
• Publication Number:
  US 20170007316A1
• Time in Patent Office: 391 Days
• 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 airway, the method comprising:

advancing a non-expandable, elongate treatment element of a treatment device through a nostril and into the patient'"'"'s airway, wherein the elongate treatment element includes a tissue-contact surface having a shape;

contacting a pair of bipolar, radiofrequency electrodes protruding from the tissue-contact surface with tissue in the airway;

applying force against the tissue with the shape of the tissue-contact surface to at least temporarily deform the tissue to a desired shape;

delivering radiofrequency energy between the electrodes, to at least one of reshape, remodel, strengthen or change a property of the tissue; and

removing the treatment element from the airway.

2. A method as in claim 1, further comprising forming an incision in mucosal tissue of the patient'"'"'s airway, wherein the tissue to which the radiofrequency energy is delivered comprises submucosal tissue.

3. A method as in claim 2, wherein the incision is formed using a cutting member on the treatment device.

4. A method as in claim 2, 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.

5. A method as in claim 1, wherein the shape of the tissue-contact surface comprises a shape selected from the group consisting of a flat shape, a convex shape, and a concave shape.

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

advancing a treatment element of a treatment device through a nostril of a patient and into the patient'"'"'s airway, the treatment device having a radiofrequency electrode needle extending from the treatment element;

inserting the radiofrequency electrode needle into tissue of the patient'"'"'s airway to reach submucosal tissue to be treated;

delivering radiofrequency energy using the inserted radiofrequency electrode needle to at least one of reshape, remodel, strengthen or change a property of the submucosal tissue to be treated; and

removing the treatment element from the airway.

7. The method of claim 6, wherein the radiofrequency electrode needle is a first radiofrequency electrode needle of a pair of bipolar radiofrequency needles, and wherein delivering radiofrequency energy using the inserted radiofrequency electrode needle comprises delivering radiofrequency energy between the pair of bipolar radiofrequency needles.

8. The method of claim 6, wherein the radiofrequency electrode needle is a first radiofrequency electrode needle of multiple radiofrequency electrode needles extending from the treatment element, and wherein delivering radiofrequency energy using the inserted radiofrequency electrode needle comprises selectively delivering energy between one or more sets of the radiofrequency electrode needles or all of the radiofrequency electrode needles.

9. The method of claim 6, further comprising applying a grounding pad to the patient, and wherein delivering radiofrequency energy using the inserted radiofrequency electrode needle comprises delivering radiofrequency energy between the radiofrequency electrode needle and the grounding pad.

10. The method of claim 6, wherein the radiofrequency electrode needle comprises an insulator on part of the radiofrequency electrode needle, and wherein delivering radiofrequency energy using the inserted radiofrequency electrode needle comprises protecting non-target tissue from the delivered radiofrequency energy using the insulator.

11. The method of claim 6, further comprising using a mold to shape, configure, or deflect tissue.

12. The method of claim 6, wherein the submucosal tissue to be treated 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.