Delivery devices with coolable energy emitting assemblies

• US 9,649,153 B2
• Filed: 10/27/2010
• Issued: 05/16/2017
• Est. Priority Date: 10/27/2009
• Status: Active Grant

• Current Assignee: Nuvaira, Inc.
• Original Assignee: Holaira, Inc. (Nuvaira, Inc.)
• Inventors: Dimmer, Steven C., Mayse, Martin L.
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): KIM, EUN HWA
• Application Number:
  US12/913,702
• Publication Number:
  US 20110152855A1
• Time in Patent Office: 2,393 Days
• Field of Search: 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 to ablate, damage, or otherwise affect tissue. The treatment systems are capable of delivering a coolable ablation assembly that ablates targeted tissue without damaging non-targeted tissue. The coolable ablation assembly damages nerve tissue to temporarily or permanently decrease nervous system input.

Claims

1. A method of treating a subject, comprising:

moving a delivery device including an elongate shaft through which coolant is capable of flowing, and an ablation assembly into an airway of a bronchial tree, the ablation assembly including a cooling element coupled directly to a distal end of the elongate shaft, and an energy emitter assembly, the energy emitter assembly including a cooling channel also coupled directly at a first end thereof to a distal end of the elongate shaft, and an energy emitter coupled to the cooling channel;

expanding the cooling element to an expanded position such that the cooling element is in contact with a wall of the airway, and the energy emitter extends at least partially circumferentially around the cooling element;

causing energy to be delivered from the energy emitter to damage nerve tissue of a nerve trunk extending along the airway; and

circulating the coolant through the elongate shaft, the cooling element, and the cooling channel of the energy emitter assembly while causing the energy to be delivered so as to cool the wall of the airway to limit or prevent cell death in tissue located between the nerve tissue and the energy emitter, and adjacent to the energy emitter.

2. The method of claim 1, further comprising:

moving the energy emitter assembly from a low-profile delivery configuration to a tissue engagement configuration before damaging the nerve tissue, wherein the energy emitter extends at least partially circumferentially around the cooling element when in the tissue engagement configuration.

3. The method of claim 2, wherein the energy emitter and the cooling channel in the tissue engagement configuration extend at least partially circumferentially about the wall of the airway.

4. The method of claim 2, wherein the energy emitter assembly in the tissue engagement configuration is in a coiled configuration.

5. The method of claim 2, further comprising rotating the energy emitter assembly with respect to the distal end of the elongate shaft to move the energy emitter assembly from the low-profile delivery configuration to the tissue engagement configuration.

6. The method of claim 1, further comprising, in series:

delivering the coolant directly from the elongate shaft to the cooling channel of the energy emitter assembly;

delivering the coolant directly from the cooling channel of the energy emitter assembly to the cooling element; and

delivering the coolant directly from the cooling element back to the elongate shaft.

7. The method of claim 1, further comprising heating the nerve tissue using the energy to cause nerve tissue cell death while maintaining a temperature of other tissue below a temperature at which cell death occurs.

8. The method of claim 1, further comprising heating the nerve tissue at a depth of about 2 mm to about 8 mm in the airway wall to cause cell death while maintaining the tissues located between the nerve tissue and the energy emitter at a depth less than 2 mm in the airway wall at a temperature below that at which cell death occurs.

9. A method of delivering energy, the method comprising:

causing energy to be delivered from an electrode fluidly coupled to a cooling channel with a substantially uniform voltage across an electrode surface in contact with a tissue without contacting the tissue with edges of the electrode,

circulating coolant through the cooling channel while the energy is being delivered from the electrode to cool the electrode surface in contact with the tissue,

wherein the electrode is movable with respect to an underlying expandable member configured to place the electrode surface in contact with the tissue, and further wherein an elongate portion of the electrode is configured to extend at least partially circumferentially around the expandable member when the expandable member is in an expanded state, and

wherein the cooling channel is directly coupled to one of a coolant inflow lumen and a coolant outflow lumen, and wherein the expandable member is directly coupled to the other of the coolant inflow lumen and the coolant outflow lumen.

10. The method of claim 9, wherein an elongate section of the cooling channel extends at least partially circumferentially around the expandable member when the expandable member is in the expanded state.

11. The method of claim 9, wherein the cooling channel is fluidly coupled to the expandable member, and wherein the coolant is circulated in series, from a coolant source, directly from the coolant inflow lumen to and through the cooling channel, directly from the cooling channel to the expandable member, and from the expandable member, back to the coolant source via the coolant outflow lumen.

12. The method of claim 9, wherein circulating the coolant through the cooling channel comprises delivering the coolant from a coolant source to the cooling channel via the coolant inflow lumen, moving the coolant through the cooling channel, and returning the coolant to the coolant source via the coolant outflow lumen.

13. The method of claim 12, wherein the expandable member is fluidly coupled to the cooling channel and the coolant outflow lumen, and wherein the coolant is circulated serially through the cooling channel and the expandable member.

14. A method of treating a subject, comprising:

moving a delivery device including an elongate shaft and an ablation assembly, and through which coolant is capable of flowing, into an airway of a bronchial tree, the ablation assembly including—

an expandable member,

a cooling channel, and

an energy emitter coupled to the cooling channel;

expanding the expandable member to an expanded position such that the energy emitter is in contact with a wall of the airway;

causing energy to be delivered from the energy emitter to damage nerve tissue of a nerve trunk extending along the airway; and

circulating coolant through the delivery device while causing the energy to be delivered to the nerve tissue so as to cool a wall of the airway to limit or prevent cell death in tissue located between the nerve tissue and the energy emitter,

wherein the cooling channel is coupled directly to a first lumen selected from a coolant inflow lumen and a coolant outflow lumen of the elongate shaft such that the coolant flows directly between the cooling channel and the first lumen without entering the expandable member.