Methods and devices to treat nasal airways

• US 9,237,924 B2
• Filed: 06/13/2012
• Issued: 01/19/2016
• 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): VOORHEES, CATHERINE M
• Application Number:
  US13/495,879
• Publication Number:
  US 20120323232A1
• Time in Patent Office: 1,315 Days
• Field of Search: 606 41- 44, 606 50- 52, 606 20- 22
• 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 device for treating a patient'"'"'s nasal airway by reshaping the nasal airway without using a surgical incision, implant or needle, the device comprising:

only one elongate, rigid shaft having a first width, a proximal end and a distal end, and defining a longitudinal axis;

only one handle at the proximal end of the elongate shaft; and

only one fixed-size, non-expandable, elongate treatment element extending from the distal end of the elongate shaft, the elongate treatment element having a second width that is larger than the first width, an elongate front tissue-contact surface, a back surface, and a length; and

two rows of non-penetrating, radiofrequency electrodes protruding laterally from the elongate front tissue-contact surface of the elongate treatment element, wherein the electrodes comprise multiple bipolar electrode pairs configured to deliver radiofrequency energy to a nasal tissue to be treated,

wherein the elongate front tissue-contact surface comprises a shallow convex shape defining a curve and configured to mechanically press laterally against the nasal tissue to be treated to reshape a region of the patient'"'"'s nasal airway to a new conformation,

wherein the length of the treatment element is parallel to the longitudinal axis of the shaft, and

wherein the curve of the convex shape of the treatment element is perpendicular to the longitudinal axis of the shaft.

2. The device of claim 1, wherein the back surface narrows distally along a portion of the length of the treatment element from a distal end of the two rows of electrodes to a distal tip of the treatment element.

3. The device of claim 1, 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 to allow for accurate temperature control and precise targeting of tissue.

4. The device of claim 1, wherein the device is configured to select one or more of the bipolar electrode pairs and separately deliver the radiofrequency energy between the one or more selected electrode pairs.

5. The device of claim 1, further comprising an insulating material interposed between the two rows of electrodes.

6. The device of claim 3, further comprising a heat sensor coupled with the front tissue-contact surface, configured to measure a temperature of a surface or a subsurface of the nasal tissue to be treated.

7. A system for improving airflow in a patient'"'"'s nasal airway by reshaping the nasal airway without using a surgical incision, implant or needle, the system comprising:

only one elongate, rigid shaft having a first width, a proximal end and a distal end, and defining a longitudinal axis;

only one handle at the proximal end of the elongate shaft;

only one fixed-size, non-expandable, elongate treatment element extending from the distal end of the elongate shaft, the elongate treatment element having a second width that is larger than the first width, an elongate front tissue-contact surface, a back surface, and a length, wherein the elongate front tissue-contact surface comprises a shallow convex shape defining a curve and configured to mechanically press laterally against a nasal tissue to be treated to reshape a region of the patient'"'"'s nasal airway to a new conformation, wherein the length of the treatment element is parallel to the longitudinal axis of the shaft, and wherein the curve of the convex shape of the treatment element is perpendicular to the longitudinal axis of the shaft;

two rows of non-penetrating, radiofrequency electrodes protruding laterally from the elongate front tissue-contact surface of the elongate treatment element, wherein the electrodes comprise multiple bipolar electrode pairs configured to deliver radiofrequency (RF) energy to the nasal tissue to be treated;

an RF energy source coupled with the elongate treatment element to provide RF energy to the two rows of electrodes; and

a cooling mechanism coupled with the treatment element for cooling at least one of the nasal tissue to be treated or a portion of nasal tissue not to be treated.

8. The system of claim 7, wherein the handle comprises a button configured to activate the two rows of electrodes.

9. The system of claim 7, further comprising an adaptor configured to be connected to the RF energy source.

10. The system of claim 7, further comprising a control system configured to control one or more characteristics of energy applied to the nasal tissue to be treated.

11. The system of claim 10, further comprising a thermocouple configured to measure a temperature near the nasal tissue to be treated.