Pressure sensitive tissue treatment device

Patent metadata

Field	Value
Publication number	US-2016287315-A1
Application number	US-201615175651-A
Country	US
Kind code	A1
Filing date	Jun 7, 2016
Priority date	Jun 14, 2011
Publication date	Oct 6, 2016
Grant date	—

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.

First claim

What is claimed is:

1 . A device for treating a patient's nasal airway to reduce airway resistance, the 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; at least two non-penetrating, bipolar, radiofrequency electrodes protruding from 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 radiofrequency electrodes are activated.

2 . The device of claim 1 , wherein the at least two radiofrequency electrodes comprise two rows of non-penetrating, bipolar, radiofrequency electrodes.

3 . The device of claim 1 , further comprising an insulating material interposed between the at least two radiofrequency electrodes.

4 . The device of claim 1 , further comprising a radiofrequency energy source coupled with the elongate treatment element to provide radiofrequency energy to the at least two radiofrequency electrodes.

5 . The device of claim 4 , wherein the radiofrequency energy source comprises a controller 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 at least two radiofrequency electrodes, based on whether the minimum amount of force is being applied.

6 . The device 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.

7 . The device of claim 1 , wherein the force control member comprises a force transducer coupled with the treatment element, and wherein a radiofrequency source coupled with the device is configured to receive force measurements from the force transducer and only provide radiofrequency energy to the at least to electrodes when the minimum amount of force is applied.

8 . The device of claim 1 , wherein the force control member comprises a tissue impedance measurement device coupled with the treatment element, and wherein a radiofrequency source coupled with the device is configured to receive tissue impedance measurements from the tissue impedance measurement device and only provide radiofrequency energy to the at least to electrodes when the minimum amount of force is applied.

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

10 . The device of claim 1 , further comprising a control system configured to control one or more characteristics of energy applied to the tissue.

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

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

13 . The method of claim 12 , wherein activating the energy delivery member comprises activating two rows of non-penetrating, bipolar, radiofrequency electrodes to deliver radiofrequency energy.

14 . The method of claim 12 , further comprising:
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; and determining, with the controller, whether the amount of force being exerted is equal to or greater than the predefined minimum amount of force.

15 . The method of claim 12 , wherein the sensor comprises a force transducer.

16 . The method of claim 12 , wherein the sensor comprises a tissue impedance measurement device.

17 . The method of claim 12 , further comprising cooling the nasal tissue, using a cooling mechanism coupled with the treatment element.

18 . The method of claim 12 , further comprising measuring a temperature of the nasal tissue using a thermocouple coupled with the tissue-contact surface of the treatment element.

19 . The method of claim 12 , wherein the tissue-contact surface has a convex shape, so that applying the laterally directed force forms a concave shape in the nasal tissue.

20 . The method of claim 19 , 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.

21 . 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.

22 . The system of claim 21 , wherein the energy delivery member comprises at least two non-penetrating, bipolar, radiofrequency electrodes.

Assignees

• Aerin Medical Inc

Inventors

• Wolf Scott J
• Frazier Andrew

Classifications

• A61B18/20

  using laser · CPC title

• A61B2018/1807

  using light other than laser radiation · CPC title

• A61B2018/00577

  Ablation · CPC title

• A61B18/1206

  Generators therefor · CPC title

• A61B2018/0016

  Energy applicators arranged in a two- or three dimensional array · CPC title