DELIVERY DEVICES WITH COOLABLE ENERGY EMITTING ASSEMBLIES

• US 20110152855A1
• Filed: 10/27/2010
• Published: 06/23/2011
• Est. Priority Date: 10/27/2009
• Status: Active Grant

• Current Assignee: Nuvaira, Inc.
• Original Assignee: Nuvaira, Inc.
• Inventors: Dimmer, Steven C., Mayse, Martin L.
• Granted Patent: US 9,649,153 B2
• Time in Patent Office: Days
• US Class Current: 606/33
• 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 delivery device, comprising:

an ablation assembly including

an energy emitter assembly configured to output energy to ablate targeted tissue of a bronchial tree and through which a coolant is capable of flowing so as to cool a tissue-contacting portion of the energy emitter assembly;

a deployable element movable from a collapsed state to an expanded state to bring the tissue-contacting portion of the energy emitter assembly into contact with an airway wall of the bronchial tree;

a cooling section configured to contain the coolant and movable into contact with the airway wall so as to cool tissue adjacent to the tissue-contacting portion of the energy emitter assembly when energy is being outputted therefrom; and

an elongate shaft coupled to the ablation assembly and through which the coolant is capable of flowing to the ablation assembly.

2. The delivery device of claim 1 wherein the deployable element comprises an inflatable member and the cooling section comprises a portion of the inflatable member.

3. The delivery device of claim 1 wherein the deployable element comprises an expandable basket and the cooling section comprises a portion of the expandable basket.

4. The delivery device of claim 1, wherein a channel of the energy emitter assembly is separate from a chamber of the deployable element to enable independent delivery of a first coolant from the elongate shaft to the channel of the energy emitter assembly and a second coolant to a chamber of the deployable element.

5. The delivery device of claim 1, wherein the energy emitter assembly includes an electrode with a coolant channel for a flow of coolant therethrough.

6. The delivery device of claim 5, wherein a first delivery lumen of the elongate shaft is in fluid communication with the coolant channel of the electrode and a second delivery lumen of the elongate shaft is in fluid communication with a chamber of the deployable element.

7. The delivery device of claim 1, wherein a section of the energy emitter assembly extends circumferentially about the deployable element and is freely movable with respect to the deployable element in a direction of a longitudinal axis of the deployable element.

8. The delivery device of claim 1, wherein a coolant channel of the energy emitter assembly fluidically couples a delivery lumen of the elongate shaft to a chamber of the deployable element, and the chamber of the deployable element is fluidically coupled to a return lumen of the elongate shaft.

9. The delivery device of claim 1, wherein the deployable element includes a main body having a first end, a second end, and a ventilation passageway extending between the first end and the second end, and the ventilation passageway being configured to allow a flow of inspiratory air therethrough and a flow of expiratory air therethrough when the deployable element is in the expanded state.

10. The delivery device of claim 1, wherein the energy emitter assembly and the deployable element are independently expandable.

11. The delivery device of claim 1, wherein the deployable element in the collapsed state is insertable into a receiving-opening of the energy emitter assembly, and the deployable element in the expanded state is configured to press radially outward against the energy emitter assembly.

12. The delivery device of claim 1, wherein the energy emitter assembly includes a radiofrequency electrode being configured to output a sufficient amount of radiofrequency energy to ablate a portion of a nerve trunk extending along the bronchial tree to attenuate nervous system signals transmitted to a portion of the bronchial tree while the deployable element is in the expanded state, and wherein the cooling section absorbs a sufficient amount of thermal energy from the airway wall to limit or prevent damage to the tissue between the energy emitter assembly and the nerve tissue.

13. The delivery device of claim 1, further comprising a throttle configured to maintain a first flow rate of the coolant through the energy emitting assembly and a second flow rate of the coolant through the cooling section.

14. The delivery device of claim 13, wherein the energy emitting assembly is fluidly connected to the cooling section such that the coolant flows serially from the energy emitting assembly to the cooling section, the throttle being disposed between the energy emitting assembly and the cooling section.

15. The delivery device of claim 13, wherein the deployable element comprises an inflatable member fluidly connected to the energy emitting assembly such that coolant flows serially from the energy emitting assembly to the inflatable member for the inflation thereof, and the cooling section comprises a portion of the inflatable member.

16. The delivery device of claim 15, wherein the throttle is disposed between the energy emitting assembly and the inflatable member.

17. The delivery device of claim 16, wherein the throttle lowers a pressure of the coolant between the energy emitting assembly and the inflatable member.

18. The delivery device of claim 1, further comprising a visible marking positioned on at least one of the elongate shaft and the deployable element, the visible marking indicating the position of the energy emitter assembly.

19. The delivery device of claim 1, wherein the deployable element is transparent such that the energy emitter assembly is viewable through a wall of the deployable element.

20. A delivery device, comprising:

an ablation assembly including an electrode configured to output energy to ablate targeted tissue of an airway, the electrode movable between a first orientation in which the electrode extends axially along the airway and a second orientation in which the entire electrode is disposed in a space between adjacent cartilage rings of the airway.

21-24. -24. (canceled)

25. A delivery device, comprising:

a deployable element movable between a collapsed state and an expanded state; and

an intercartilaginous energy emitter assembly surrounding at least a portion of the deployable element, at least a portion of the energy emitter assembly is moveable with respect to the deployable element in the expanded state to urge an electrode of the energy emitter assembly between adjacent cartilage rings of an airway wall of a bronchial tree.

26-31. -31. (canceled)

32. A delivery device, comprising:

an ablation assembly including an energy emitter assembly and an inflatable cooling balloon, the energy emitter assembly including a cooling channel, the inflatable cooling balloon including a cooling chamber; and

an elongate shaft configured to independently deliver a first fluid to the cooling channel and a second fluid to the cooling chamber.

33-41. -41. (canceled)

42. A delivery device comprising:

an elongate shaft; and

an ablation assembly coupled to the elongate shaft and including an electrode, the electrode being capable of emitting ablation energy and having a first end, a second end, and a main body between the first end and the second end, at least one of the first end and the second end is covered by an ablation energy insulator.

43-45. -45. (canceled)

46. A treatment system, comprising:

a delivery device configured to deliver energy to a first tissue surface proximate the delivery device to damage a target region of tissue such that a portion of the target region defining a maximum cross-sectional width of the target region is separated from the first tissue surface.

47-54. -54. (canceled)

55. A method of treating a subject, comprising:

moving a cooling element of a delivery device through a receiving-opening of an energy emitter assembly located in an airway of the subject;

expanding the cooling element to position at least a portion of the energy emitter assembly between the cooling element and a wall of the airway; and

delivering energy from the energy emitter assembly to ablate tissue in the wall of the airway while coolant flows through the expanded cooling element and the energy emitter assembly.

56-59. -59. (canceled)

60. A method of treating a subject, comprising:

moving an ablation assembly into an airway of a bronchial tree, the ablation assembly including a cooling element and an energy emitter assembly;

expanding the cooling element to contact a wall of the airway with the cooling element;

delivering energy from the energy emitter assembly to damage nerve tissue of a nerve trunk extending along the airway; and

flowing coolant into contact with at least a portion of the energy emitter assembly while delivering the energy to cool a wall of the airway to limit or prevent cell death in tissue located between the damaged nerve tissue and the ablation assembly.

61. The method of claim 60, further comprising delivering the coolant out of discharge ports of the energy emitter assembly towards the tissue.

62. The method of claim 60, further comprising spraying the coolant against the tissue to cool the tissue.

63. The method of claim 60, further comprising delivering the coolant through a Joule-Thomson throttle to reduce the temperature of the coolant that cools the wall of the airway.

64. The method of claim 60 wherein passing the coolant through the energy emitter assembly includes delivering the coolant through a cooling channel of the energy emitter assembly.

65. The method of claim 60, further comprising:

moving the energy emitter assembly from a low-profile delivery configuration to a tissue engagement configuration before damaging the nerve tissue.

66. The method of claim 65, wherein the energy emitter assembly in the tissue engagement configuration extends circumferentially about the wall of the airway.

67. The method of claim 65, wherein the energy emitter assembly in the tissue engagement configuration is in a coiled configuration.

68. The method of claim 65, further comprising rotating the energy emitter assembly with respect to a distal end of an elongate shaft to move the energy emitter assembly from the low-profile delivery configuration to the tissue engagement configuration.

69. The method of claim 60, further comprising:

delivering coolant from an elongate shaft to the energy emitter assembly;

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

delivering coolant from the cooling element to the elongate shaft.

70. The method of claim 60, further comprising independently delivering coolants through the energy emitter assembly and the cooling element.

71. The method of claim 60, further comprising heating nerve tissue using the energy to cause nerve tissue cell death while maintaining the temperature of other tissue below a temperature at which cell death occurs.

72. The method of claim 60, further comprising heating tissue at a depth of about 2 mm to about 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 that at which cell death occurs.

73. The method of claim 60, wherein expanding the cooling element includes forming a ventilation passageway to allow a flow of inspiratory air therethrough and a flow of expiratory air therethrough.

74. The method of claim 60, further comprising delivering the coolant out of a port at an end of a delivery conduit, the end of the delivery conduit extending away from a longitudinal axis of the ablation assembly towards an electrode of the energy emitter assembly.

75. The method of claim 60, further comprising:

moving a portion of a delivery conduit through a chamber of the cooling element and towards the energy emitter assembly; and

delivering coolant from a port of the delivery conduit to cool an electrode of the energy emitter assembly.

76. A method of treating a subject, comprising:

positioning an ablation assembly of a delivery device within an airway;

delivering energy from an electrode of the ablation assembly to damage nerve tissue of a nerve trunk such that nervous system signals transmitted to a portion of the bronchial tree are attenuated; and

delivering coolant through a channel of the electrode of the ablation assembly.

77. The method of claim 76, further comprising delivering coolant through the channel of the electrode while the electrode outputs the energy.

78. A method of treating tissue, comprising:

delivering energy to the tissue from a delivery device positioned near a first surface of the tissue, wherein the energy damages a target region such that a portion of the target region defining a maximum cross-sectional width of the target region is separated from the first surface.

79. The method of claim 78, wherein the maximum cross-sectional width of the target region is at a depth at least 2 mm from the first surface.

80. The method of claim 78, further comprising damaging a narrowed region of tissue between the first surface and a portion of the target region that defines the maximum cross-sectional width of the target region.

81. The method of claim 78, further comprising damaging tissue of the target region such that the cross-sectional width of the target region is maximized at a depth deeper than a region of smooth muscle tissue in the tissue.

82. The method of claim 78, wherein delivering energy comprises damaging the target region such that a majority of the target region is outside a region of smooth muscle tissue of the tissue.

83. The method of claim 78, further comprising damaging the target region such that a centroid area of a cross-section of the target region is deeper than a region of smooth muscle of the tissue.

84. The method of claim 78, wherein most of a volume of the damaged tissue is outside of a region of smooth muscle tissue.

85-88. -88. (canceled)

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

delivering energy from an electrode with a substantially uniform voltage across the electrode surface in contact with the tissue without contacting the tissue with edges of the electrode.

90-92. -92. (canceled)