Methods of treating nasal airways with radiofrequency energy

• US 10,398,489 B2
• Filed: 05/16/2017
• Issued: 09/03/2019
• 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): Carey, Michael J
• Application Number:
  US15/596,455
• Publication Number:
  US 20170252100A1
• Time in Patent Office: 840 Days
• Field of Search: 606 41
• 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

A device is described for treating a nasal airway by modifying a property of a nasal 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 the nasal airway. Various embodiments include an elongate shaft, a bipolar radiofrequency delivery member extending from one end of the shaft, and a handle attached to the elongate shaft at an opposite end from the radiofrequency delivery member. The radiofrequency delivery member is sized to be inserted into a nose and configured to at least temporarily deform the nasal tissue and deliver radiofrequency energy. The radiofrequency delivery member includes two rows of protruding electrodes disposed on a tissue contact surface, and the device is configured to deliver radiofrequency energy from one row of electrodes to the other row of electrodes.

Claims

1. A method for treating nasal obstruction by reshaping or remodeling submucosal tissue of a nasal airway, the method comprising:

contacting a treatment element of a nasal airway treatment device directly with nasal mucosa of the nasal airway, wherein the treatment element comprises two rows of bipolar electrode pairs;

applying pressure with the treatment element against the nasal mucosa to deform submucosal tissue underlying the nasal mucosa;

applying radiofrequency energy with the bipolar electrode pairs through the nasal mucosa and to the submucosal tissue, while continuing to apply pressure with the treatment element and without injecting fluid into the nasal airway, to heat the submucosal tissue; and

removing the treatment element from the nasal airway,

wherein applying the pressure and the radiofrequency energy reshapes or remodels the submucosal tissue, and wherein the submucosal tissue remains at least partially reshaped or remodeled after the treatment element is removed.

2. The method of claim 1, wherein the submucosal tissue comprises cartilage located in an internal nasal valve area of the nasal airway.

3. The method of claim 1, further comprising controlling at least one characteristic of the applied radiofrequency energy with a control system coupled with the nasal airway treatment device.

4. The method of claim 1, wherein the radiofrequency energy is applied in the form of a 460 kHz sinusoid wave.

5. The method of claim 1, further comprising:

sensing a temperature of the nasal mucosa using a thermocouple positioned between the two rows of bipolar electrode pairs on the treatment element; and

modifying an amount of the radiofrequency energy applied to the submucosal tissue based on the sensed temperature.

6. The method of claim 1, further comprising displaying one or more parameters of treatment while the radiofrequency energy is applied, the one or more parameters selected from the group consisting of treatment time, power level, temperature sensed by the treatment element, electric impedance, electric current, and depth of treatment.

7. The method of claim 1, further comprising applying local anesthesia to the nasal mucosa before applying the radiofrequency energy.

8. The method of claim 1, wherein the radiofrequency energy is produced by a radiofrequency energy source configured to run between 1 Watt and 100 Watts.

9. The method of claim 1, wherein applying the radiofrequency energy comprises heating the submucosal tissue to a temperature of 50 degrees Celsius to 70 degrees Celsius.

10. The method of claim 1, wherein the radiofrequency energy is applied to the submucosal tissue for at least 15 seconds, and wherein the method further comprises, before removing the treatment element from the nasal airway:

repositioning the treatment element to contact a different portion of nasal mucosa;

applying pressure with the treatment element against the different portion of nasal mucosa to deform submucosal tissue underlying the different portion of nasal mucosa; and

applying radiofrequency energy with the bipolar electrode pairs through the different portion of nasal mucosa and to the submucosal tissue, while continuing to apply pressure with the treatment element, for an additional at least 15 seconds.

11. A method of decreasing nasal airflow resistance or perceived airflow resistance, the method comprising:

contacting a treatment element of a nasal airway treatment device directly with nasal mucosa of a nasal airway, wherein the treatment element comprises two rows of bipolar radiofrequency electrode pairs; and

directly applying radiofrequency energy through the nasal mucosa to heat submucosal tissue underlying the nasal mucosa, without injecting fluid into the nasal airway, using the two rows of bipolar radiofrequency electrode pairs, such that the submucosal tissue shrinks, tightens, or stiffens while the submucosal tissue heals, thereby decreasing nasal airflow resistance or perceived airflow resistance within the nasal airway.

12. The method of claim 11, further comprising repositioning, remodeling, or reshaping the submucosal tissue with the treatment element, wherein the submucosal tissue remains at least partially repositioned, remodeled or reshaped after the submucosal tissue heals.

13. The method of claim 11, wherein the submucosal tissue comprises cartilage located in an internal nasal valve area of the nasal airway.

14. The method of claim 11, wherein the submucosal tissue is heated to a sub-ablative temperature.

15. The method of claim 11, further comprising:

sensing a temperature of the nasal mucosa, using a thermocouple positioned between the two rows of bipolar radiofrequency electrode pairs on the treatment element; and

modifying an amount of the radiofrequency energy applied to the submucosal tissue based on the sensed temperature.