Pressure sensitive tissue treatment device

• US 9,888,957 B2
• Filed: 06/07/2016
• Issued: 02/13/2018
• 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:
  US15/175,651
• Publication Number:
  US 20160287315A1
• Time in Patent Office: 616 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 system for treating a patient'"'"'s nasal airway to reduce airway resistance, the system comprising:

a nasal tissue treatment device, comprising;

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

a handle at the proximal end of the elongate shaft;

an elongate treatment element extending from the distal end of the elongate shaft, the treatment element having a front tissue-contact surface and a length that is parallel to the longitudinal axis of the shaft, wherein the front tissue-contact surface comprises a shallow convex shape defining a curve that is perpendicular to the longitudinal axis of the shaft;

an energy delivery member on the front tissue-contact surface of the treatment element; and

a force control member coupled with the front tissue-contact surface of the treatment element and configured to facilitate requiring a minimum amount of force to be applied against tissue in the nasal airway by the front tissue-contact surface before the energy delivery member is activated; and

a controller coupled with the nasal tissue treatment device and configured to receive a sensed force parameter signal from the force control member, determine whether the minimum amount of force is being applied against the tissue in the nasal airway, based on the sensed force parameter, and determine whether to activate the energy delivery member, based on whether the minimum amount of force is being applied.

2. The system of claim 1, wherein the force control member comprises a spring mounted pressure plate coupled with the treatment element, and wherein the front tissue-contact surface of the treatment element comprises a front surface of the pressure plate.

3. The system of claim 1, further comprising a cooling mechanism coupled with the treatment element for cooling the tissue in the nasal airway.

4. The system of claim 1, wherein the controller is further configured to control one or more characteristics of energy delivery by the energy delivery member.

5. The system of claim 1, further comprising a thermocouple coupled with the front tissue-contact surface, configured to measure a temperature near the tissue.

6. The system of claim 1, wherein the energy delivery member comprises at least two non-penetrating, bipolar, radiofrequency electrodes.

7. The system of claim 1, wherein the force control member comprises at least one sensor selected from the group consisting of a force transducer and a tissue impedance sensor.

8. The system of claim 1, wherein the controller comprises an energy delivery box that is further configured to provide energy to the energy delivery member.

9. The system of claim 2, wherein the pressure plate requires that the minimum amount of force be applied before the energy delivery member is activated.

10. The system of claim 6, wherein the at least two radiofrequency electrodes comprise two rows of non-penetrating, bipolar, radiofrequency electrodes.

11. The system of claim 6, wherein the nasal tissue treatment device further comprises an insulating material interposed between the at least two radiofrequency electrodes.

12. The system of claim 6, further comprising a radiofrequency energy source coupled with the elongate treatment element to provide radiofrequency energy to the at least two radiofrequency electrodes.

13. The system of claim 12, wherein the radiofrequency energy source comprises the controller.

14. The system of claim 6, wherein the force control member comprises a force transducer coupled with the treatment element, and wherein the system further comprises a radiofrequency source coupled with the device and configured to receive force measurements from the force transducer and only provide radiofrequency energy to the at least two electrodes when the minimum amount of force is applied.

15. The system of claim 6, wherein the force control member comprises a tissue impedance measurement device coupled with the treatment element, and wherein the system further comprises a radiofrequency source coupled with the device and configured to receive tissue impedance measurements from the tissue impedance measurement device and only provide radiofrequency energy to the at least two electrodes when the minimum amount of force is applied.

16. A method for treating a patient'"'"'s nasal airway to reduce airway resistance, the method comprising:

advancing an elongate treatment element of a nasal tissue treatment device into one of the patient'"'"'s nostrils;

applying laterally directed force with a tissue-contact surface of the treatment element against nasal tissue of the airway;

sensing a parameter, with a sensor coupled with the treatment member, that is indicative of an amount of force being exerted against the nasal tissue by the tissue-contact surface;

receiving, in a controller coupled with the nasal tissue treatment device, a sensed parameter signal from the sensor;

determining, with the controller, the amount of force being exerted against the nasal tissue, based on the sensed parameter;

determining, with the controller, whether the amount of force being exerted is equal to or greater than a predefined minimum amount of force; and

when the sensed parameter indicates that the amount of force being exerted is equal to or greater than the predefined minimum amount of force, activating an energy delivery member on the tissue-contact surface to delivery energy to the nasal tissue.

17. The method of claim 16, wherein activating the energy delivery member comprises activating two rows of non-penetrating, bipolar, radiofrequency electrodes to deliver radiofrequency energy.

18. The method of claim 16, wherein the sensor comprises a force transducer.

19. The method of claim 16, wherein the sensor comprises a tissue impedance measurement device.

20. The method of claim 16, further comprising cooling the nasal tissue, using a cooling mechanism coupled with the treatment element.

21. The method of claim 16, further comprising measuring a temperature of the nasal tissue using a thermocouple coupled with the tissue-contact surface of the treatment element.

22. The method of claim 16, wherein the tissue-contact surface has a convex shape, so that applying the laterally directed force forms a concave shape in the nasal tissue.

23. The method of claim 22, wherein the energy is delivered while the laterally directed force is applied, and wherein the concave shape in the nasal tissue is retained at least temporarily after the treatment element is removed from the nostril.