Systems, assemblies, and methods for treating a bronchial tree

• US 9,668,809 B2
• Filed: 08/22/2012
• Issued: 06/06/2017
• Est. Priority Date: 05/09/2008
• Status: Active Grant

• Current Assignee: Nuvaira, Inc.
• Original Assignee: Holaira, Inc. (Nuvaira, Inc.)
• Inventors: Dimmer, Steven C., Mayse, Martin L.
• Primary Examiner(s): GIULIANI, THOMAS ANTHONY
• Application Number:
  US13/592,075
• Publication Number:
  US 20120316559A1
• Time in Patent Office: 1,749 Days
• Field of Search: 606 32, 606 42, 606 41, 607 42, 607 98, 607 99, 607113, 607115
• 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 catheter, including;

an elongate body including an inflow lumen and an outflow lumen,

a continuous elongated electrode having an axial dimension, the electrode being configured to output energy to ablate nerve tissue in or around an airway wall of a bronchial tree, and

an expandable balloon movable between a collapsed state and an expanded state, wherein the expandable balloon is longitudinally and circumferentially dimensioned to contact an inner surface of the airway wall immediately adjacent to the electrode on opposing sides thereof when the expandable balloon is in the expanded state,

wherein, as the expandable balloon expands, the electrode is configured to move towards and into contact with an area on the airway wall which defines an electrode-tissue interface when the expandable balloon is in the expanded state,

wherein, when the expandable balloon is in the expanded state, the electrode extends circumferentially about the expandable balloon and portions of the expandable balloon are configured to contact the inner surface of the airway wall immediately adjacent to and on both proximal and distal sides of the electrode, wherein the 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, and

wherein the inflow lumen of the elongate body is fluidly coupled to a coolant inlet proximate to one axial end of the expandable balloon and the outflow lumen of the elongate body is fluidly coupled to a coolant outlet proximate an opposite axial end of the expandable balloon such that coolant is configured to circulate within and through the expanded balloon from the coolant inlet to the coolant outlet to remove heat from the electrode and the inner surface of the airway wall immediately adjacent to the electrode-tissue interface;

a bronchoscope defining a delivery lumen for receiving the catheter;

a coolant source configured to supply a coolant to the inflow lumen of the elongated body of the catheter at a selected temperature and a selected flow rate to circulate the coolant within the expandable balloon when the balloon is in the expanded state;

a radiofrequency generator coupled to the electrode to deliver power thereto; and

a treatment controller configured to control the power from the radiofrequency generator to the electrode when the coolant is circulated within the expandable balloon to cause cell death in a target region spaced radially outwardly from epithelium at the electrode-tissue interface to thereby form a circumferentially extending lesion spaced radially outwardly from the electrode-tissue interface, while limiting cell death in at least a portion of the epithelium between the target region and the electrode-tissue interface and immediately adjacent the electrode-tissue interface.

2. The system of claim 1, wherein the electrode extends circumferentially about the expandable balloon.

3. The system 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 system of claim 1, wherein the electrode is coupled to an exterior surface of the expandable balloon.

5. The system of claim 1, further comprising, in addition to and spaced apart from the continuous elongated electrode, at least a second continuous elongated electrode coupled to the expandable balloon and configured to output energy.

6. The system of claim 1, further comprising an ultrasound probe coupled to a distal end of the catheter, the ultrasound probe capable of outputting ultrasound energy through a wall of the expandable balloon for imaging.

7. The system of claim 1, wherein the treatment controller and the coolant source 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.

8. The system of claim 1, wherein the treatment controller is configured to control the power from the radiofrequency generator to the electrode when the coolant is circulated within the expandable balloon at the selected temperature and the selected flow rate to limit cell death to depths ranging from about 3 millimeters to about 5 millimeters away from the electrode-tissue interface.

9. The system of claim 1, wherein the treatment controller is configured to control the power from the radiofrequency generator to the electrode when the coolant is circulated within the expandable balloon at the selected temperature and the selected flow rate to limit cell death to a 2 to 3 millimeter band of tissue in the airway wall.

10. The system of claim 1, further comprising at least one sensor configured to send one or more signals indicative of one or more of tissue characteristics, energy distribution, and tissue temperature to the treatment controller.

11. The system of claim 10, wherein the treatment controller has a closed loop system, whereby the power from the radiofrequency generator to the electrode is controlled based upon feedback signals from the at least one sensor.

12. A system for use in an airway of a subject comprising:

a catheter comprising;

a shaft having an inflow lumen and an outflow lumen,

a continuous elongate electrode coupled to the shaft and movable from a radially inward configuration to a radially outward configuration, and

a heat sink coupled to the inflow and outflow lumens to allow circulation of a coolant therethrough, the heat sink being movable to a deployed configuration, wherein the heat sink is dimensioned to contact an epithelial surface of the airway immediately adjacent to the electrode on opposing sides thereof when the heat sink is in the deployed configuration such that the heat sink is in thermal communication with the electrode and the epithelial surface of the airway,

wherein, as the heat sink deploys, the electrode is configured to move from the radially inward configuration to the radially outward configuration in which the electrode is configured to engage an area of the epithelial surface defining an electrode-tissue interface, and the heat sink is configured to conform to both the electrode and the epithelial surface immediately adjacent to the electrode on opposing sides thereof, and

wherein, when the heat sink is in the deployed configuration, the electrode extends circumferentially about the heat sink, and the heat sink is configured to contact the epithelial surface of the airway for an axial dimension immediately adjacent to and on both proximal and distal sides of the electrode, wherein the axial dimension of the heat sink in contact with the epithelial surface on each side of the electrode is greater than an axial dimension of the electrode;

a bronchoscope defining a delivery lumen for receiving the catheter;

a coolant source coupled to the inflow lumen of the catheter and configured to circulate the coolant at a selected temperature and a selected flow rate within the heat sink to cool the epithelial surface sufficiently to inhibit cell death in at least a portion of the epithelium adjacent the electrode-tissue interface when the heat sink is in the deployed configuration and in thermal communication with the electrode and the epithelial surface;

a radiofrequency generator coupled to the electrode to deliver power thereto; and

a treatment controller configured to control the power from the radiofrequency generator to the electrode when the coolant is circulated at the selected temperature and the selected flow rate such that ablation energy is concentrated in a target region spaced radially outwardly from the electrode-tissue interface more than in tissue immediately adjacent the electrode-tissue interface to cause cell death in the target region while limiting cell death between the target region and the epithelial surface, thereby forming a circumferentially extending lesion spaced radially outwardly from the electrode-tissue interface.

13. The system of claim 12, wherein the electrode is positioned outside of the heat sink such that the electrode is capable of outputting energy directly to the airway wall.

14. The system of claim 12, wherein the electrode is coupled to an exterior surface of the heat sink.

15. The system of claim 12, further comprising, in addition to and spaced apart from the continuous elongate electrode, at least a second continuous elongate electrode coupled to the heat sink and configured to output energy.

16. The system of claim 12, wherein the treatment controller is configured to control the power from the radiofrequency generator to the electrode when the coolant is circulated within the heat sink at the selected temperature and the selected flow rate to limit cell death to depths ranging from about 2 millimeters to about 8 millimeters away from the electrode-tissue interface.

17. The system of claim 12, wherein the treatment controller is configured to control the power from the radiofrequency generator to the electrode when the coolant is circulated within the heat sink at the selected temperature and the selected flow rate to limit cell death to depths ranging from about 3 millimeters to about 5 millimeters away from the electrode-tissue interface.

18. The system of claim 12, wherein the treatment controller is configured to control the power from the radiofrequency generator to the electrode when the coolant is circulated within the heat sink at the selected temperature and the selected flow rate to limit cell death to a 2 to 3 millimeter band of tissue in the airway wall.

19. The system of claim 12, further comprising at least one sensor configured to send one or more signals indicative of one or more of tissue characteristics, energy distribution, and tissue temperature to the treatment controller.

20. The system of claim 19, wherein the treatment controller has a closed loop system, whereby the power from the radiofrequency generator to the electrode is controlled based upon feedback signals from the at least one sensor.

21. A system for use in an airway of a subject comprising:

a catheter comprising;

a shaft having an inflow lumen and an outflow lumen,

a single continuous elongated energy emitting element coupled to the shaft, the energy emitting element being configured to engage an area on an epithelial surface of an epithelium of the airway which defines an energy emitting element-tissue interface, and

a heat sink coupled to the inflow and outflow lumens to allow circulation of a coolant therethrough, the heat sink being movable to a deployed configuration in which the heat sink is configured to be in thermal communication with the energy emitting element and the epithelial surface of the airway,

wherein, as the heat sinks deploys, the energy emitting element is configured to move towards and into contact with the epithelial surface, and the heat sink is configured to conform to both energy emitting element and the epithelial surface immediately adjacent to the energy emitting element on opposing sides thereof, and

wherein, when the heat sink is in the deployed configuration, contacting portions of the heat sink are dimensioned to contact the epithelial surface immediately adjacent to and on both proximal and distal sides of the energy emitting element, wherein an axial dimension of the energy emitting element is substantially less than an axial dimension of the contacting portions of the heat sink;

a bronchoscope defining a delivery lumen for receiving the catheter;

a coolant source coupled to the inflow lumen of the catheter and configured to circulate the coolant at a selected temperature and a selected flow rate within the heat sink to cool the energy emitting element and epithelium immediately adjacent the energy emitting element-tissue interface sufficiently to inhibit cell death in at least the epithelium;

an energy generator coupled to the energy emitting element to deliver energy thereto; and

a treatment controller configured to control the energy from the energy generator to the energy emitting element when the coolant is circulated at the selected temperature and the selected flow rate,

wherein the system is configured to concentrate ablation energy in a target region spaced radially outwardly from the energy emitting element-tissue interface more than in tissue adjacent the energy emitting element-tissue interface to cause cell death in the target region while limiting cell death between the target region and the energy emitting element-tissue interface, thereby forming a circumferentially extending lesion spaced radially outwardly from the electrode-tissue interface.

22. The system of claim 21, wherein the energy emitting element is at an electrode.

23. The system of claim 22, wherein the energy generator is a direct current power source.

24. The system of claim 22, wherein the energy generator is an alternating current power source.

25. The system of claim 21, wherein the energy emitting element is at least one antenna element.

26. The system of claim 25, wherein the energy generator is a microwave energy source.

27. The system of claim 25, wherein the energy generator is a pulsed high voltage source.

28. The system of claim 21, wherein the energy emitting element is at least one heating element.

29. The system of claim 21, wherein the energy emitting element is at least one light emitting element and the energy generator is a light source.

30. The system of claim 21, wherein the energy emitting element is at least one light source.

31. The system of claim 21, wherein the energy emitting element is at least one ultrasonic element and the energy generator is at least one excitation source.

32. The system of claim 21, wherein the treatment controller is configured to control the power from the energy generator to the energy emitting element when the coolant is circulated within the heat sink at the selected temperature and the selected flow rate to limit cell death to depths ranging from about 2 millimeters to about 8 millimeters away from the energy emitting-tissue interface.

33. The system of claim 21, wherein the treatment controller is configured to control the power from the energy generator to the energy emitting element when the coolant is circulated within the heat sink at the selected temperature and the selected flow rate to limit cell death to depths ranging from about 3 millimeters to about 5 millimeters away from the energy emitting-tissue interface.

34. The system of claim 21, wherein the treatment controller is configured to control the power from the energy generator to the energy emitting element when the coolant is circulated within the heat sink at the selected temperature and the selected flow rate to limit cell death to a 2 to 3 millimeter band of tissue in the airway wall.