Delivery devices with coolable energy emitting assemblies

• US 9,017,324 B2
• Filed: 06/28/2013
• Issued: 04/28/2015
• 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:
  US13/931,246
• Publication Number:
  US 20130289556A1
• Time in Patent Office: 669 Days
• Field of Search: 606/32, 606/41, 606/42, 606/47, 606/34, 607/42, 607/98, 607/99, 607/113, 607/115, 607/154, 607/96
• 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-targeted tissue from damage. The coolable ablation assembly damages nerve tissue to temporarily or permanently decrease nervous system input.

Claims

1. A pulmonary treatment apparatus, comprising:

an elongated shaft having proximal and distal ends, an inflow lumen and an outflow lumen extending between the proximal and distal ends;

an ablation assembly configured to be positioned in an airway of a subject and coupled to the distal end of the shaft, the ablation assembly including an expandable member, a fluid delivery conduit, and one or more energy emitters coupled to the fluid delivery conduit and movable relative to an underlying surface of the expandable member, the fluid delivery conduit and the expandable member being fluidly coupled to the inflow lumen and the outflow lumen, wherein the ablation assembly is movable from a delivery configuration in which the one or more energy emitters are configured to be delivered through a channel having a diameter of less than 6 mm, to a deployed configuration in which the fluid delivery conduit at least partially wraps circumferentially around the expandable member, the one or more energy emitters radially project from a surface of the expandable member such that, when positioned in the airway, each of the one or more energy emitters is configured to engage a wall of the airway in at least one intercartilagenous space extending between adjacent cartilaginous rings of the airway, and the expandable member is configured to engage the wall of the airway both distally and proximally of each of the one or more energy emitters;

a source of energy coupled to the one or more energy emitters and configured to deliver energy thereto such that one or more lesions are created in target tissue spaced radially outwardly from the surface of the wall of the airway; and

a cooling system fluidly coupled to the inflow lumen and configured to deliver a coolant to the ablation assembly so as to cool the expandable member and the one or more energy emitters such that a portion of the surface of the wall is cooled sufficiently that airway tissue disposed between the one or more energy emitters and the target tissue is not permanently damaged,

wherein the one or more energy emitters are configured to create the one or more lesions that extend around a circumference of the airway within the at least one intercartilagenous space without repositioning the one or more energy emitters.

2. The pulmonary treatment apparatus of claim 1, wherein the one or more energy emitters comprise a single long electrode.

3. The pulmonary treatment apparatus of claim 1, wherein the one or more energy emitters comprise a plurality of circumferentially spaced apart electrodes.

4. The pulmonary treatment apparatus of claim 3, wherein the electrodes are spaced between 45 and 210 degrees apart.

5. The pulmonary treatment apparatus of claim 3, wherein the electrodes are spaced 45 degrees apart.

6. The pulmonary treatment apparatus of claim 3, wherein the electrodes are spaced 90 degrees apart.

7. The pulmonary treatment apparatus of claim 3, wherein the electrodes are spaced 180 degrees apart.

8. The pulmonary treatment apparatus of claim 3, wherein the plurality includes three electrodes.

9. The pulmonary treatment apparatus of claim 8, wherein the three electrodes are spaced about 60 degrees apart.

10. The pulmonary treatment apparatus of claim 1, wherein the one or more energy emitters form a helical configuration.

11. The pulmonary treatment apparatus of claim 1, wherein the one or more energy emitters comprise a pair of bipolar electrodes.

12. The pulmonary treatment apparatus of claim 1, wherein the one or more energy emitters comprise a plurality of axially and circumferentially spaced-apart electrodes.

13. The pulmonary treatment apparatus of claim 1, wherein the one or more energy emitters comprise a first portion positionable in a first intercartilagenous space and a second portion positionable in a second intercartilagenous space when the first portion is positioned in the first intercartilagenous space.

14. The pulmonary treatment apparatus of claim 13, wherein the first portion comprises a first electrode and the second portion comprises a second electrode spaced apart from the first electrode.

15. The pulmonary treatment apparatus of claim 1, wherein the one or more energy emitters are configured to deliver RF energy to the airway wall.

16. The pulmonary treatment apparatus of claim 1, wherein the one or more energy emitters are configured to deliver microwave energy to the airway wall.

17. The pulmonary treatment apparatus of claim 1, wherein the one or more energy emitters are configured to deliver ultrasound energy to the airway wall.

18. The pulmonary treatment apparatus of claim 1, wherein the one or more energy emitters are movable from the delivery configuration to the deployed configuration by the expandable member.

19. The pulmonary treatment apparatus of claim 1, wherein the expandable member is configured to engage and cool airway tissue adjacent to the surface of the airway wall engaged by the one or more energy emitters.

20. The pulmonary treatment apparatus of claim 1, wherein the one or more energy emitters include an electrode coupled to the fluid delivery conduit.

21. The pulmonary treatment apparatus of claim 20, wherein the electrode is a collapsible electrode.

22. The pulmonary treatment apparatus of claim 1, wherein the one or more energy emitters include an electrode comprised of a foil, film or coating.

23. A pulmonary treatment apparatus, comprising:

an elongated shaft having proximal and distal ends, an inflow lumen and an outflow lumen extending between the proximal and distal ends;

an ablation assembly configured to be positioned in an airway of a subject and coupled to the distal end of the shaft, the ablation assembly including an expandable member, a fluid delivery conduit, and one or more energy emitters coupled to the fluid delivery conduit and movable relative to an underlying surface of the expandable member, the fluid delivery conduit and the expandable member being fluidly coupled to the inflow lumen and the outflow lumen, wherein the ablation assembly is movable from a delivery configuration in which the one or more energy emitters are configured to be delivered through a channel having a diameter of less than 6 mm, to a deployed configuration in which the fluid delivery conduit at least partially wraps circumferentially around the expandable member, the one or more energy emitters radially project from a surface of the expandable member such that, when positioned in the airway, each of the one or more energy emitters is configured to engage a wall of the airway in at least one intercartilagenous space extending between adjacent cartilaginous rings of the airway, and the expandable member is configured to engage the wall of the airway both distally and proximally of each of the one or more energy emitters;

a source of energy coupled to the one or more energy emitters and configured to deliver energy thereto such that a lesion is created in target tissue spaced radially outwardly from the surface of the wall of the airway; and

a cooling system fluidly coupled to the inflow lumen and configured to deliver a coolant to the ablation assembly so as to cool a portion of the surface of the wall sufficiently that airway tissue disposed between the one or more energy emitters and the target tissue is not permanently damaged,

wherein the one or more energy emitters of the ablation assembly are configured to extend around an arc at least about 180 degrees in length about a circumference of the airway within the at least one intercartilagenous space in the deployed configuration.

24. The pulmonary treatment apparatus of claim 23, wherein the one or more energy emitters are configured to create a lesion extending around the entire airway circumference without repositioning the one or more energy emitters.

25. The pulmonary treatment apparatus of claim 23, wherein the one or more energy emitters comprise first and second portions circumferentially spaced from each other by about 45 to about 210 degrees.

26. The pulmonary treatment apparatus of claim 25, wherein the first and second portions are circumferentially spaced about 90 degrees apart.

27. The pulmonary treatment apparatus of claim 25, wherein the first and second portions are circumferentially spaced about 180 degrees apart.

28. The pulmonary treatment apparatus of claim 23, wherein the one or more energy emitters comprise a single electrode.

29. The pulmonary treatment apparatus of claim 23, wherein the one or more energy emitters comprise a plurality of discrete electrodes.

30. A treatment apparatus, comprising:

an elongated shaft having proximal and distal ends, an inflow lumen and an outflow lumen extending between the proximal and distal ends;

an ablation assembly configured to be positioned in a lumen of a subject and coupled to the distal end of the shaft, the ablation assembly including an expandable member, a fluid delivery conduit, and one or more energy emitters coupled to the fluid delivery conduit and movable relative to an underlying surface of the expandable member, the fluid delivery conduit and the expandable member being fluidly coupled to the coolant inflow and outflow lumens, wherein the ablation assembly is movable between a delivery configuration and a deployed configuration in which a longitudinal portion of the fluid delivery conduit extends at least partially circumferentially around the expandable member, the one or more energy emitters are configured to engage a wall of the lumen, and the expandable member is configured to engage the wall of the lumen both distally and proximally of the one or more energy emitters;

a source of energy coupled to the one or more energy emitters and configured to deliver energy thereto such that one or more lesions are created in target tissue spaced radially outwardly from the surface of the wall of the lumen; and

a cooling system fluidly coupled to the inflow lumen and the outflow lumen, the cooling system being configured to deliver coolant to the ablation assembly so as to cool the expandable member and the one or more energy emitters such that a portion of the surface of the wall is cooled sufficiently that tissue radially disposed between the one or more energy emitters and the target tissue is not permanently damaged.