Systems, assemblies, and methods for treating a bronchial tree

• US 10,149,714 B2
• Filed: 02/08/2017
• Issued: 12/11/2018
• Est. Priority Date: 05/09/2008
• Status: Active Grant

• Current Assignee: Nuvaira, Inc.
• Original Assignee: Nuvaira, Inc.
• Inventors: Mayse, Martin L., Dimmer, Steven C.
• Primary Examiner(s): Giuliani, Thomas
• Application Number:
  US15/427,685
• Publication Number:
  US 20170143421A1
• Time in Patent Office: 671 Days
• Field of Search: 606 41, 606 46, 606 47
• 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 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• 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 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1432 curved
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61N 7/022 : intracavitary

Abstract

Systems, assemblies, and methods to treat pulmonary diseases are used to decrease nervous system input to distal regions of the bronchial tree within the lungs. Treatment systems damage nerve tissue to temporarily or permanently decrease nervous system input. The treatment systems are capable of heating nerve tissue, cooling the nerve tissue, delivering a flowable substance that cause trauma to the nerve tissue, puncturing the nerve tissue, tearing the nerve tissue, cutting the nerve tissue, applying pressure to the nerve tissue, applying ultrasound to the nerve tissue, applying ionizing radiation to the nerve tissue, disrupting cell membranes of nerve tissue with electrical energy, or delivering long acting nerve blocking chemicals to the nerve tissue.

Claims

1. A system, comprising:

a treatment controller; and

a catheter comprising;

an elongated body through which a coolant is capable of flowing;

an electrode configured to output energy to ablate nerve tissue in an airway wall of an airway of a bronchial tree; and

an expandable balloon having a collapsed state and an expanded state, wherein the expandable balloon in the expanded state is dimensioned to contact the airway wall of the bronchial tree, wherein the expandable balloon is coupled to the elongated body and configured to receive and contain the coolant such that the coolant cools the electrode and expandable balloon when the catheter is in contact with the airway wall to limit or prevent damage to tissue between the electrode and the nerve tissue, wherein the electrode is coupled to the expandable balloon such that the electrode is moved towards the airway wall as the expandable balloon moves from the collapsed state to the expanded state, wherein, when the expandable balloon is in the expanded state, portions of the expandable balloon are configured to contact an inner surface of the airway wall immediately adjacent to and on both proximal and distal sides of the electrode, wherein an axial dimension of the electrode is less than an axial dimension of each of the portions of the expandable balloon in contact with the inner surface of the airway wall, the axial dimension of the electrode and the axial dimension of each of the portions extending along a longitudinal axis of the airway;

wherein the treatment controller is configured to control power to the electrode when coolant is circulated within the expandable balloon to output a sufficient amount of energy to damage the nerve tissue at a first location along the airway spaced radially outwardly from the inner surface of the airway wall at an electrode-tissue interface so as to attenuate transmission of signals to and/or from mucous producing cells at a second location along the airway so as to reduce a production of mucous from the mucous producing cells, while limiting damage to at least a portion of the tissue between the first location and the electrode-tissue interface and immediately adjacent the electrode-tissue interface.

2. The catheter of claim 1, wherein the electrode extends circumferentially about the expandable balloon when the expandable balloon is in the expanded state.

3. The catheter of claim 1, wherein the electrode is positioned outside of the expandable balloon such that the electrode is capable of outputting energy directly to the airway wall.

4. The catheter of claim 1, wherein the electrode is embedded in a wall of the expandable balloon.

5. The catheter of claim 1, wherein the electrode is coupled to an exterior surface of the expandable balloon or an interior surface of the expandable balloon.

6. The catheter of claim 1, further comprising a plurality of circumferentially spaced apart electrodes coupled to the expandable balloon and configured to output energy.

7. The catheter of claim 1, further comprising an ultrasound probe capable of outputting ultrasound energy through a wall of the expandable balloon for imaging.

8. The catheter of claim 1, wherein the electrode and the expandable balloon are configured to raise a temperature of the nerve tissue to cause cell death of the nerve tissue while maintaining a temperature of the tissue between the first location and the electrode-tissue interface and immediately adjacent the electrode-tissue interface below a temperature at which cell death occurs.

9. The catheter of claim 1, wherein the electrode and the expandable balloon are configured to cooperate to raise the temperature of tissue at a depth of 2 mm to 8 mm in the airway wall to cause cell death, while maintaining tissues at a depth less than 2 mm in the airway wall at a temperature below a temperature at which cell death occurs.

10. The system of claim 1, further comprising:

a coolant source coupled to the catheter, and a radiofrequency generator coupled to the catheter and the controller;

wherein the coolant source is configured to deliver coolant to the expandable balloon and the radiofrequency generator is configured to deliver energy to the electrode to concentrate heating in outer layers of the airway wall.

11. The system of claim 10, wherein the coolant source is configured to output a low temperature coolant that absorbs thermal energy to cool tissue contacting the expandable balloon.

12. The system of claim 10, further comprising:

a bronchoscope having a delivery lumen for receiving the catheter.

13. A method of treating an airway condition caused by excessive intraluminal mucus, mucous glands hypertrophy, or both, the method comprising:

using the system of claim 1, causing damage to nerve tissue at a first location along the airway so as to attenuate transmission of signals to and/or from mucous producing cells at a second location along the airway so as to reduce a production of mucous from the mucous producing cells.

14. The method of claim 13, wherein causing damage to nerve tissue comprises damaging efferent nerve tissue to inhibit signals from being transmitted from the brain to mucous producing cells of the airway.

15. The method of claim 13, wherein causing damage to nerve tissue disrupts a baseline level of mucous secretion.

16. The method of claim 13, wherein causing damage to nerve tissue attenuates transmission of signals traveling along vagus nerves that cause mucus production.

17. The method of claim 16, wherein attenuation of the transmission of signals comprises decreasing signal amplitude or weakening transmission of signals.

18. The method of claim 13, wherein attenuation of the transmission of signals comprises hindering, limiting, blocking, and/or interrupting transmission of signals.

19. The method of claim 13, wherein the method decreases a sufficient amount of mucus production to cause substantial decrease in coughing and/or airflow resistance.

20. The method of claim 13, wherein the method further comprises, after causing damage to nerve tissue:

providing a questionnaire or test to assess a subject'"'"'s response to treatment by assessing a subject'"'"'s quality of life and comparing the assessment to an assessment of the subject'"'"'s quality of life before damaging the nerve tissue.

21. The method of claim 13, wherein causing damage to nerve tissue comprises:

outputting energy from the electrode of the catheter positioned in the airway to heat and ablate the nerve tissue along the airway wall at the first location; and

cooling a portion of the expandable balloon to cool an inner portion of the airway wall while outputting the energy to inhibit damage to the inner portion of the wall while the nerve tissue is ablated.

22. The method of claim 13, wherein causing damage to nerve tissue comprises:

delivering energy from the electrode of the catheter positioned in the airway to destroy the nerve tissue along the wall of the airway while avoiding injury to airway tissue distal the damaged nerve tissue.

23. The method of claim 13, wherein the nerve tissue is positioned between a trachea and a lung of a subject.

24. The method of claim 13, wherein causing damage to nerve tissue includes ablating nerve tissue of a nerve trunk along a right main bronchus, a left main bronchus, or both.