Methods and devices to treat airways

• US 9,452,010 B2
• Filed: 06/29/2015
• Issued: 09/27/2016
• 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, GEORGE C
• Application Number:
  US14/754,087
• Publication Number:
  US 20150297285A1
• Time in Patent Office: 456 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 treating a patient'"'"'s airway, the method comprising:

advancing a non-expandable, elongate treatment element of a treatment device into an incision in mucosal tissue of the airway, wherein the elongate treatment element includes a tissue-contact surface having a convex shape;

contacting two rows of non-penetrating, bipolar, radiofrequency electrode pairs protruding laterally from the tissue-contact surface with submucosal tissue of the airway;

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

delivering an energy based therapy to the submucosal tissue through the treatment element, by delivering radiofrequency energy between the two rows of electrode pairs, to at least one of reshape, remodel, strengthen or change a property of the submucosal tissue; and

removing the treatment element from the airway.

2. A method as in claim 1, further comprising forming the incision in the mucosal tissue, using the treatment device.

3. A method as in claim 2, wherein forming the incision comprises cutting the mucosal tissue with a cutting edge of the treatment device.

4. A method as in claim 1, 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 device for modifying at least one property of at least one tissue in an airway, the device comprising:

a head portion configured for passing through an incision in mucosal tissue to a location between the mucosal tissue and submucosal tissue, the head portion comprising;

an energy delivery member, comprising;

a tissue-contact surface with a convex shape configured to at least temporarily create a concavity in the at least one tissue; and

two rows of non-penetrating, bipolar, radiofrequency electrode pairs protruding laterally from the convex shaped tissue-contact surface

an incision forming member, comprising a blade extending from the energy delivery member;

a shaft extending from the head portion; and

a handle attached to the shaft at an opposite end from the head portion.

6. A device as in claim 5, wherein the energy delivery member comprises multiple flexible sections configured to be manipulated.

7. A device as in claim 6, wherein the flexible sections comprise the radiofrequency electrode pairs, which are configured to at least temporarily deform tissue.

8. A device as in claim 5, wherein the handle comprises a housing configured to hold at least one battery for powering the energy delivery member.

9. A device as in claim 5, further comprising at least one sensor configured to sense at least one of temperature or impedance in tissue.

10. A device as in claim 9, wherein the at least one sensor is attached to the device on or near the energy delivery member.

11. A device as in claim 5, further comprising a tissue cooling member attached to the device at or near the energy delivery member.

12. A device as in claim 5, further comprising at least one thermocouple configured to sense temperature at each of the electrode pairs.

13. A device as in claim 12, further comprising a processor to determine an average temperature from multiple temperatures sensed by more than one of the at least one thermocouple.

14. A device as in claim 5, wherein each of the electrode pairs is configured to deliver a separately adjustable radio frequency current, which is adjustable for any pair of the electrode pairs separately from adjustment of any other of the electrode pairs.