Delivery devices with coolable energy emitting assemblies

• US 8,777,943 B2
• Filed: 06/28/2013
• Issued: 07/15/2014
• Est. Priority Date: 10/27/2009
• Status: Active Grant

• Current Assignee: Nuvaira, Inc.
• Original Assignee: Holaira, Inc. (Nuvaira, Inc.)
• Inventors: Mayse, Martin L., Dimmer, Steven C.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): GIULIANI, THOMAS ANTHONY
• Application Number:
  US13/931,208
• Publication Number:
  US 20130289555A1
• Time in Patent Office: 382 Days
• Field of Search: 606/32, 606/41, 606/42, 606/47, 607/42, 607/98, 607/99, 607/113, 607/115, 607/154
• US Class Current: 606/41
• CPC Class Codes: A61B 1/2676 Bronchoscopes
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• 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 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00017 with gas
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00029 open
• 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 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/00577 Ablation
• 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 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61N 2007/0043 intra-cavitary

Abstract

Systems, delivery devices, and methods to treat, ablate, damage, or otherwise affect tissue in an airway of a patient. The treatment systems are capable of delivering a coolable ablation assembly that ablates targeted tissue while cooling non-targeted tissue to protect the non-target tissue from damage. The coolable ablation assembly damages nerve tissue to temporarily or permanently decrease nervous system input.

Claims

1. A catheter system, comprising:

an elongate body having a coolant delivery lumen and a coolant return lumen; and

an ablation assembly coupled to a distal end of the elongate body and being positionable through a working channel into in an airway of a patient, the ablation assembly being movable from a collapsed configuration having a collapsed cross-section to an expanded configuration having an expanded cross-section, the collapsed cross-section having a collapsed transverse dimension not more than about 6 mm and the expanded cross-section having an expanded transverse dimension of at least about 7 mm so as to contact an airway wall of the patient, the ablation assembly including —

an energy emitter assembly having a tissue-contacting portion, the energy emitter assembly being configured to deliver energy through surface tissue of the airway wall to target tissue spaced radially outward from the surface tissue at a power sufficient to ablate said target tissue,

a coolant directing element adapted to actively direct a portion of coolant from the coolant delivery lumen toward the energy emitter assembly to cool the tissue-contacting portion of the energy emitter assembly and to cool a first surface tissue in contact with the tissue-contacting portion of the energy emitter assembly so as to inhibit permanent damage to the first surface tissue while the energy emitter assembly delivers energy to the target tissue; and

a cooling member configured to cool a second surface tissue adjacent to the tissue-contacting portion of the energy emitter assembly so as to inhibit permanent damage to the second surface tissue while the energy emitter assembly delivers energy to the target tissue;

wherein the coolant directing element comprises a fluid delivery conduit fluidly coupled to the coolant delivery lumen and which at least partially wraps around the cooling member in the expanded configuration.

2. The catheter system of claim 1, wherein the collapsed transverse dimension of the ablation assembly is less than about 3 mm.

3. The catheter system of claim 1, wherein the cooling member comprises a balloon having an inflated balloon diameter in a range of about 7 mm to about 25 mm when the ablation assembly is in the expanded configuration, and a minimum diameter in a range of about 2 mm to about 3 mm in the collapsed configuration.

4. The catheter system of claim 1, wherein fluid delivery conduit has an expanded diameter in a range of about 1.5 mm to about 3 mm when the ablation assembly is in the expanded configuration, and a collapsed diameter in a range of about 0.1 mm to about 1 mm when the ablation assembly is in the collapsed configuration.

5. The catheter system of claim 1, wherein the fluid delivery conduit has in fluid communication with the coolant delivery lumen to receive coolant therefrom, and wherein the energy emitter assembly comprises at least one electrode coupled to or positioned on the fluid delivery conduit.

6. The catheter system of claim 5, wherein the cooling member is coupled to the coolant delivery conduit to receive coolant therefrom, and wherein the cooling member is further coupled to the coolant return lumen such that the coolant is circulatable from the coolant delivery lumen, through the fluid delivery conduit, the cooling member, and to the coolant return lumen so as to cool the first and second surface tissue simultaneously.

7. The catheter system of claim 6, wherein the cooling member is a balloon and the fluid delivery conduit extends at least partially around a circumference of the balloon in the expanded configuration.

8. The catheter system of claim 1, wherein the cooling member is a balloon that is inflatable from the collapsed configuration to the expanded configuration to move the tissue-contacting portion of the energy emitter assembly towards and in contact with the airway wall of the patient.

9. The catheter system of claim 1, wherein the energy emitter assembly includes one or more electrodes positioned on a surface of the cooling member.

10. The catheter system of claim 1, wherein the energy emitter assembly is configured to deliver RF energy to the airway wall.

11. The catheter system of claim 1, wherein the energy emitter assembly is configured to deliver microwave energy to the airway wall.

12. The catheter system of claim 1, wherein the energy emitter assembly is configured to deliver ultrasound energy to the airway wall.

13. The catheter system of claim 1, wherein the energy emitter comprises a flexible electrode and is moveable from a lower profile configuration to a higher profile configuration.

14. The catheter system of claim 1, wherein the energy emitter assembly includes an electrode comprising a film or coating.

15. The catheter system of claim 14, wherein the film or coating includes a conductive polymer.

16. The catheter system of claim 1, wherein the energy emitter assembly includes an electrode comprising an electrically conductive foil.

17. The catheter system of claim 1, wherein at least a portion of the energy emitter assembly is movable from a generally axial orientation in the collapsed configuration to a more circumferential orientation in the expanded configuration.

19. The catheter system of claim 1, wherein the cooling member is a balloon in fluid communication with the fluid delivery conduit, and an internal throttle valve controls a relative pressure between the conduit and the balloon.

18. The catheter system of claim h wherein the cooling member is configured to contact a surface of the airway wall immediately adjacent to the energy emitter assembly to minimize permanent damage to the surface tissue.

20. A catheter system, comprising:

an elongate body having a coolant delivery lumen therein; and

an ablation assembly coupled to a distal end of the elongate body and being positionable through a working channel into in an airway of a patient, the ablation assembly being movable from a collapsed configuration having a collapsed cross-section to an expanded configuration having an expanded cross-section, the collapsed cross-section having a collapsed transverse dimension not more than about 6 mm and the expanded cross-section having an expanded transverse dimension of at least about 7 mm so as to contact an airway wall of the patient, the ablation assembly including;

a fluid delivery conduit having a coolant channel fluidly connected to the coolant delivery lumen;

an electrode coupled to the fluid delivery conduit and configured to deliver energy through surface tissue of the airway wall to target tissue spaced radially outward from the surface tissue, at least a portion of the electrode having a tissue-contacting portion, wherein the fluid delivery conduit is adapted to actively direct a portion of coolant from the coolant delivery lumen toward the electrode to cool the tissue-contacting portion of the electrode and a first surface tissue in contact with the tissue-contacting portion of the electrode so as to inhibit permanent damage to the first surface tissue while the electrode delivers energy to the target tissue; and

a cooling member configured to contact and cool a second surface tissue adjacent the tissue-contacting portion of the electrode so as to inhibit permanent damage to the second surface tissue while the electrode delivers energy to the target tissue;

wherein the fluid delivery conduit at least partially wraps around the cooling member in the expanded configuration.

21. The catheter system of claim 20, wherein the fluid delivery conduit is disposed along an outer surface of the cooling member in at least the expanded configuration.

22. The catheter system of claim 21, wherein the fluid delivery conduit is collapsible so as to have a first height relative to the outer surface of the cooling member in the collapsed configuration and a second height relative to the outer surface in the expanded configuration.

23. The catheter system of claim 20, wherein the cooling member is fluidly connected to the coolant channel of the fluid delivery conduit to receive coolant therefrom, and wherein the cooling member and the fluid delivery conduit are in fluid communication such that the coolant is circulatable from the coolant delivery lumen to the fluid delivery conduit and the cooling member so as to cool the first and second surface tissue simultaneously.

24. The catheter system of claim 20, wherein the cooling member is expandable from a collapsed diameter to an expanded diameter.

25. The catheter system of claim 24, wherein the electrode is coupled to the cooling member so as to be elongated as the cooling member expands.

26. The catheter system of claim 20, wherein the electrode is a collapsible electrode.

27. The catheter system of claim 20, wherein the electrode is flexible.