Methods and devices to treat nasal airways

• US 10,265,115 B2
• Filed: 09/06/2017
• Issued: 04/23/2019
• 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:
  US15/696,905
• Publication Number:
  US 20170360495A1
• Time in Patent Office: 594 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 for treating a deviated nasal septum in a patient, the method comprising:

inserting a treatment element of a nasal airway treatment device into a nasal airway of the patient, wherein the treatment element comprises;

a treatment surface; and

two rows of bipolar radiofrequency electrodes disposed along the treatment surface;

applying force to the deviated nasal septum with the treatment surface of the treatment element to alter a shape of the deviated nasal septum; and

delivering radiofrequency energy to the deviated nasal septum with the two rows of bipolar radiofrequency electrodes on the treatment surface of the treatment element,

wherein the deviated nasal septum at least partially maintains the altered shape after the treatment element is removed and the nasal septum heals.

2. The method of claim 1, further comprising sensing a temperature of the deviated nasal septum with a temperature sensing member located between the two rows of bipolar radiofrequency electrodes on the treatment surface.

3. The method of claim 1, further comprising expanding an expansion portion of the treatment element, thereby applying the force to the deviated nasal septum with the treatment surface.

4. The method of claim 3, wherein expanding the expansion portion comprises increasing a diameter of a nasal passage at the deviated nasal septum beyond a normal range in order for the diameter to remain expanded after removal of the treatment element and the nasal septum heals.

5. The method of claim 1, wherein at least part of the treatment surface of the treatment element has a convex shape, and wherein the two rows of bipolar radiofrequency electrodes are aligned perpendicular to a radius of curvature of the convex shape.

6. The method of claim 1, wherein the treatment element is non-expandable.

7. A device for treating a deviated nasal septum in a patient, the device comprising:

an elongate shaft having a proximal end and a distal end, the elongate shaft defining a longitudinal axis;

a handle at the proximal end of the elongate shaft;

a fixed-size, non-expandable, treatment element extending from the distal end of the elongate shaft, the treatment element having a front tissue-contact surface, a back surface, and a length that is parallel to the longitudinal axis of the shaft; and

two rows of non-penetrating, radiofrequency electrodes disposed along the front tissue-contact surface of the treatment element, wherein the electrodes comprise multiple bipolar electrode pairs configured to deliver radiofrequency energy to the deviated nasal septum, and wherein the two rows are parallel to the longitudinal axis.

8. The device of claim 7, wherein the treatment element is wider than the elongate shaft.

9. The device of claim 7, wherein the front tissue-contact surface of the treatment element comprises a shallow convex shape defining a curve and configured to mechanically press laterally against the deviated nasal septum to reshape the deviated nasal septum, and wherein the curve of the convex shape of the front tissue-contact surface is perpendicular to the longitudinal axis defined by the elongate shaft.

10. The device of claim 7, wherein the handle is the sole handle of the device.

11. The device of claim 7, wherein each of the multiple bipolar electrode pairs has a separate, controlled electrical channel, configured to allow different regions of the treatment element to be activated separately.

12. The device of claim 7, further comprising a heat sensor coupled with the front tissue-contact surface between the two rows of radiofrequency electrodes, configured to measure a temperature of the deviated nasal septum.

13. The device of claim 7, wherein the back surface of the treatment element does not contain any electrodes.

14. A method for treating a deviated nasal septum of a nasal airway, the method comprising:

inserting a reshaping element into a first nostril of the nasal airway;

inserting a non-expandable treatment element into a second nostril of the nasal airway, wherein the treatment element comprises;

a treatment surface; and

two rows of bipolar radiofrequency electrodes disposed along the treatment surface;

contacting the reshaping element and the treatment surface of the treatment element with opposite sides of the deviated nasal septum;

altering a shape of the deviated nasal septum using the reshaping element; and

delivering radiofrequency energy to the deviated nasal septum using the radiofrequency electrodes on the treatment surface of the treatment element.

15. The method of claim 14, wherein the reshaping element and the treatment element are each part of separate devices.

16. The method of claim 14, further comprising:

inserting a positioning element into the nasal airway; and

obtaining one or more measurements with the positioning element,

wherein a position of at least one of the reshaping element or the treatment element relative to the deviated nasal septum during delivery of the radiofrequency energy is based, at least in part, on the obtained one or more measurements.