NON-INVASIVE AND MINIMALLY INVASIVE DENERVATION METHODS AND SYSTEMS FOR PERFORMING THE SAME

• US 20170245911A1
• Filed: 05/16/2017
• Published: 08/31/2017
• Est. Priority Date: 11/11/2009
• Status: Active Grant

• Current Assignee: Nuvaira, Inc.
• Original Assignee: Holaira, Inc. (Nuvaira, Inc.)
• Inventors: Mayse, Martin L., Dimmer, Steven C.
• Granted Patent: US 10,610,283 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• 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 2017/00323 Cables or rods
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00279 deployable
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• 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 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61N 2005/0604 : Lungs and/or airways
• CPC Class Codes: A61N 2005/0651 : Diodes
• CPC Class Codes: A61N 2007/003 : Destruction of nerve tissue
• CPC Class Codes: A61N 5/0601 : Apparatus for use inside the body
• CPC Class Codes: A61N 5/062 : Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 5/1077 : Beam delivery systems
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: A61N 7/022 : intracavitary

Abstract

A system and method can be used to denervate at least a portion of a bronchial tree. An energy emitter of an instrument is percutaneously delivered to a treatment site and outputs energy to damage nerve tissue of the bronchial tree. The denervation procedure can be performed without damaging non-targeted tissue. Minimally invasive methods can be used to open airways to improve lung function in subjects with COPD, asthma, or the like. Different sections of the bronchial tree can be denervated while leaving airways intact to reduce recovery times.

Claims

1. A method, comprising:

providing an instrument to a user, the instrument including an energy emitter positioned at a distal section of the instrument; and

providing instructions to the user, the instructions comprising;

moving the energy emitter through the skin of a subject;

wrapping the distal section of the instrument around an airway of the bronchial tree of the subject to position the energy emitter with respect to nerve tissue along the airway of the bronchial tree;

energizing the energy emitter to damage the nerve tissue using energy from the energy emitter while the energy emitter is positioned outside of the airway; and

removing the instrument from the subject.

2. The method of claim 1, wherein providing an instrument to a user comprises causing the instrument to be manufactured and made available to the user, and wherein providing instructions to the user comprises providing instructions for use or directions for accessing instructions for use, said instructions for use or directions being recorded on a tangible medium.

3. The method of claim 1, wherein the instructions further comprise monitoring the airway so as to leave the airway intact throughout the denervation process.

4. The method of claim 1, wherein the instructions for energizing the energy emitter to damage the nerve tissue further comprise instructions for ablating a section of a nerve trunk to impede transmission of nervous system signals traveling along the airway.

5. The method of claim 1, wherein the instructions for energizing the energy emitter to damage the nerve tissue further comprise delivering at least one of radiofrequency energy, microwave energy, radiation energy, high intensity focused ultrasound energy, and thermal energy from the energy emitter to damage the nerve tissue.

6. The method of claim 1, wherein the instructions further comprise percutaneously delivering the energy emitter proximate to the nerve tissue prior to damaging the nerve tissue.

7. The method of claim 1, wherein the instructions further comprise:

moving an intraluminal instrument through the subject'"'"'s trachea and the airway; and

delivering energy between the energy emitter of the instrument outside the airway and the intraluminal instrument positioned within the airway to ablate the nerve tissue.

8. The method of claim 1, wherein the instructions for energizing the energy emitter to damage the nerve tissue further comprise instructions for irreversibly damaging nerve tissue between the subject'"'"'s trachea and the subject'"'"'s lung to at least partially block a transmission of nervous system signals and to cause a permanent decrease in smooth muscle tone of the portion of a bronchial tree.

9. The method of claim 1, wherein the instructions for energizing the energy emitter to damage the nerve tissue the nerve tissue further comprise instructions for ablating the nerve tissue while monitoring the airway so as not to pass the instrument through a wall of the airway.

10. The method of claim 1, wherein the instructions for energizing the energy emitter to damage the nerve tissue further comprise instructions for destroying the nerve tissue while monitoring the airway so as not to substantially damage blood vessels of the airway.

11. The method of claim 1, wherein the instructions for energizing the energy emitter to damage nerve tissue further comprise instructions for damaging nerve tissue positioned along a main bronchus of the bronchial tree.

12. The method of claim 1, wherein the instructions further comprise visualizing the outside of the airway while positioning the energy emitter using a visualization device selected from a group consisting of a thoracoscope, an ultrasonic device, and a fluoroscopy system.

13. The method of claim 1, wherein the instructions for moving the energy emitter through the skin of a subject further comprise moving the energy emitter through a port, a cannula, or a sleeve extending through the skin of the subject.

14. A method, comprising:

providing an instrument to a user; and

providing instructions to the user, the instructions comprising;

percutaneously delivering a distal section of the instrument through the skin of a subject and wrapping the distal section of the instrument around an airway of a bronchial tree of the subject such that the distal section is positioned to damage nerve tissue of the bronchial tree; and

delivering energy to a first portion of the bronchial tree using the instrument to substantially inhibit nervous system signals from traveling to a second portion of the bronchial tree.

15. The method of claim 14, wherein providing an instrument to a user comprises causing the instrument to be manufactured and made available to the user, and wherein providing instructions to the user comprises providing instructions for use or directions for accessing instructions for use, said instructions for use or directions being recorded on a tangible medium.

16. The method of claim 14, wherein the instructions further comprise damaging a nerve trunk positioned along a main bronchus.

17. The method of claim 14, wherein the instructions for denervating a first portion of the bronchial tree further comprise instructions for damaging nerve tissue positioned between the subject'"'"'s trachea and lung.

18. The method of claim 14, wherein the instructions for denervating a first portion of the bronchial tree further comprise instructions for ablating a sufficient amount of nerve tissue to prevent nervous system signals from traveling to substantially all bronchial branches of the bronchial tree.

19. The method of claim 14, wherein the instructions for denervating a first portion of the bronchial tree further comprise instructions for removing the instrument without destroying the airway.

20. The method of claim 14, wherein the instructions for percutaneously delivering a distal section of the instrument through the skin of a subject further comprise instructions for delivering a distal section of the instrument through a port, a cannula, or a sleeve extending through the subject'"'"'s skin.

21. The method of claim 14, wherein the instructions for percutaneously delivering a distal section of the instrument through the skin of a subject further comprise instructions for visualizing the outside of the airway while delivering the distal section of the instrument using a visualization device selected from a group consisting of a thoracoscope, an ultrasonic device, and a fluoroscopy system.