Delivery devices with coolable energy emitting assemblies

• US 8,740,895 B2
• Filed: 06/28/2013
• Issued: 06/03/2014
• 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:
  US13/930,825
• Publication Number:
  US 20130296647A1
• Time in Patent Office: 340 Days
• Field of Search: 606/32, 606/41, 606/42, 606/47, 606/16, 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-targeted tissue from damage. The coolable ablation assembly damages nerve tissue to temporarily or permanently decrease nervous system input.

Claims

1. A delivery device, comprising:

an elongate body having a coolant delivery lumen; and

an ablation assembly positionable in an airway of a bronchial tree, including;

an energy emitter assembly configured to output energy to ablate targeted tissue of the bronchial tree; and

a deployable element movable from a collapsed state to an expanded state, the deployable element configured to contain and circulate a coolant delivered through the coolant delivery lumen and being movable into contact with a wall of the airway,

wherein the deployable element has a surface which is configured for optical coupling with an optical element which is configured to be positioned in the airway outside of the deployable element, the optical element facing the surface of the deployable element such that the energy emitter assembly is viewable through the surface of the deployable element with the optical element when the deployable element is in the expanded state or a partially expanded state.

2. The delivery device according to claim 1, wherein the deployable element comprises an inflatable member.

3. The delivery device according to claim 1, wherein the ablation assembly is positionable through a working channel of a bronchoscope, the optical element being disposed on a distal end of the bronchoscope, the surface of the deployable element being configured to provide optical coupling with the optical element when the ablation assembly is positioned distally of the working channel with the elongate body extending through the working channel.

4. The delivery device according to claim 3, wherein the surface includes a section that is substantially parallel to a plane of a distal end of the optical element such that the optical element optically couples with the section when the deployable element is in the expanded state or the partially expanded state.

5. The delivery device according to claim 1, wherein the deployable element is a transparent balloon.

6. The delivery device according to claim 1, wherein the deployable element is a semi-transparent balloon.

7. The delivery device according to claim 1, wherein the deployable element is a conformable balloon that is made, at least in part, of a highly compliant material.

8. The delivery device according to claim 1, wherein the surface is disposed at an angle relative to a longitudinal axis of the elongate body selected such that the optical element may be positioned in contact with the surface such that the ablation assembly is viewable through the surface and the coolant with the optical element when the deployable element is in the expanded state or the partially expanded state.

9. The delivery device according to claim 8, wherein the surface is disposed at an angle of about 75 degrees to about 105 degrees relative to the longitudinal axis of the elongate body.

10. The delivery device of claim 9, wherein the surface is approximately perpendicular to the longitudinal axis of the elongate body.

11. The delivery device according to claim 1, wherein a material of the surface of the deployable element includes a refractive index that is compatible with air and the coolant within the deployable element such that the ablation assembly is viewable through the surface and the coolant with the optical element.

12. The delivery device according to claim 1, wherein a material of the surface of the deployable element includes a refractive index that optimizes visibility and transparency relative to the optical element.

13. The delivery device according to claim 1, wherein a section of the energy emitter assembly extends circumferentially about the deployable element.

14. The delivery device according to claim 1, wherein the energy emitter assembly is configured to deliver microwave energy to the airway wall.

15. The delivery device according to claim 1, wherein the energy emitter assembly is configured to deliver ultrasound energy to the airway wall.

16. The delivery device according to claim 1, wherein the energy emitter comprises an RF electrode.

17. The delivery device according to claim 1, wherein the energy emitter is disposed along an outer surface of the deployable element in the expanded state.

18. The delivery device according to claim 1, wherein the energy emitter is spaced radially a first distance from a longitudinal axis when the deployable element is in the expanded state, the surface being configured to be optically coupled with the optical element at a location which is spaced radially a second distance from the longitudinal axis, the second distance being substantially less than the first distance.

19. The delivery device according to claim 1, wherein the energy emitter assembly comprises a tissue-contacting portion,

wherein the energy emitter assembly includes a coolant directing element adapted to actively direct coolant from the coolant delivery lumen toward the energy emitter assembly to cool the tissue-contacting portion of the energy emitter assembly and 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 is delivering energy to ablate the target tissue, and

wherein the deployable element is configured to receive coolant from the coolant delivery lumen to cool a second surface tissue of the airway adjacent to the energy emitter assembly so as to inhibit permanent damage to the second surface tissue while the energy emitter assembly is delivering energy to ablate the target tissue.

20. An energy delivery system, comprising:

an optical element configured for visualization in an airway of a bronchial tree;

an elongate body having a coolant delivery lumen; and

an ablation assembly coupled to the elongate body and positionable in the airway, including;

an energy emitter assembly configured to output energy to ablate targeted tissue of the bronchial tree; and

a deployable element movable from a collapsed state to an expanded state, the deployable element configured to contain and circulate a coolant delivered through the coolant delivery lumen and being movable into contact with a wall of the airway, wherein the optical element is configured to be positioned outside of the deployable element, and wherein the deployable element has a surface which is configured for optical coupling with the optical element in the airway such that the energy emitter assembly is viewable through the surface of the deployable element with the optical element when the deployable element is in the expanded state.

21. The energy delivery system according to claim 20, wherein the ablation assembly is configured to allow anatomical features to be viewed through the surface of the deployable element using the optical element.

22. The energy delivery system according to claim 20, further comprising a delivery apparatus positionable in the airway, the optical element being coupled to the delivery apparatus and configured to be pressed against the surface of the deployable element to optically couple with the deployable element.

23. The energy delivery system according to claim 22, wherein the delivery apparatus includes a working lumen through which the elongate shaft extends.

24. The energy delivery system according to claim 23, wherein the delivery apparatus is a bronchoscope.

25. The energy delivery system according to claim 22, wherein the delivery apparatus includes a sheath with fiber optics.

26. The energy delivery system according to claim 25, wherein the fiber optics are configured for coupling to a camera.

27. The energy delivery system according to claim 20, wherein the deployable member is configured to receive coolant from the coolant delivery lumen to cool surface tissue of the airway adjacent to the energy emitter assembly while the energy emitter assembly delivers energy to ablate the target tissue.

28. The energy delivery system according to claim 20, wherein the ablation assembly further comprises a conduit fluidly connected to the coolant delivery lumen, the energy emitter assembly being coupled to the conduit such that coolant flowing through conduit cools the energy emitter assembly, thereby cooling tissue in contact with the energy emitter assembly.