SYSTEMS, ASSEMBLIES, AND METHODS FOR TREATING A BRONCHIAL TREE

• US 20090306644A1
• Filed: 05/08/2009
• Published: 12/10/2009
• Est. Priority Date: 05/09/2008
• Status: Active Grant

• Current Assignee: Nuvaira, Inc.
• Original Assignee: Innovative Pulmonary Solutions, Incorporated
• Inventors: Dimmer, Steven C., Mayse, Martin L.
• Granted Patent: US 8,088,127 B2
• Time in Patent Office: Days
• US Class Current: 606/33
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• 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 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• 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 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1432 curved
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61N 7/022 : intracavitary

Abstract

Systems, assemblies, and methods to treat pulmonary diseases are used to decrease nervous system input to distal regions of the bronchial tree within the lungs. Treatment systems damage nerve tissue to temporarily or permanently decrease nervous system input. The treatment systems are capable of heating nerve tissue, cooling the nerve tissue, delivering a flowable substance that cause trauma to the nerve tissue, puncturing the nerve tissue, tearing the nerve tissue, cutting the nerve tissue, applying pressure to the nerve tissue, applying ultrasound to the nerve tissue, applying ionizing radiation to the nerve tissue, disrupting cell membranes of nerve tissue with electrical energy, or delivering long acting nerve blocking chemicals to the nerve tissue.

Claims

1. A method for treating a subject, the method comprising:

damaging nerve tissue of a nerve trunk extending along an airway of a bronchial tree to attenuate nervous system signals transmitted to a portion of the bronchial tree.

2. The method of claim 1, wherein the nerve tissue is damaged while maintaining a functionality of one or more arteries extending along the airway so as to preserve a respiratory function of the portion of the bronchial tree after the nerve tissue is damaged.

3. The method of claim 1, wherein damaging the nerve tissue comprises irreversibly damaging the nerve tissue to at least partially block a transmission of nervous system signals and to cause a permanent decrease in smooth muscle tone of the portion of the bronchial tree.

4. The method of claim 1, wherein the nerve tissue is damaged without damaging to any significant extent a portion of the airway that is circumferentially adjacent to the damaged nerve tissue.

5. The method of claim 1, wherein the nerve tissue is damaged without damaging to any significant extent smooth muscle in a wall of the airway.

6. The method of claim 1, wherein damaging the nerve tissue comprises:

delivering energy to the nerve tissue; and

destroying a section of the nerve tissue using the delivered energy such that the destroyed section impedes transmission of nervous system signals traveling along the nerve tissue.

7. The method of claim 1, wherein damaging the nerve tissue comprises increasing a temperature of the nerve tissue to a first temperature while a portion of a wall of the airway is at a second temperature that is less than the first temperature, the portion of the wall is positioned radially inward from the nerve tissue at the first temperature.

8. The method of claim 1, further comprising:

moving an elongate assembly along a lumen of the airway prior to damaging the nerve tissue using the elongate assembly.

9. The method of claim 1, wherein the nerve tissue is positioned along a main bronchus of the bronchial tree so as to attenuate the nervous system signals to a substantial portion of the bronchial tree distal to the main bronchus.

10. The method of claim 9, wherein the nerve tissue is generally positioned between a trachea and a lung of the subject.

11. The method of claim 1, wherein damaging the nerve tissue includes ablating nerve tissue along a right main bronchus and ablating nerve tissue along a left main bronchus.

12. The method of claim 1, further comprising:

moving a distal tip of an elongate assembly through at least a portion of a wall of the airway such that an activatable element of the elongate assembly is positioned to damage the nerve tissue when the activatable element is activated.

13. The method of claim 12, wherein moving the distal tip comprises positioning the activatable element closer to the nerve tissue than to a nearest artery in the wall of the airway.

14. The method of claim 1, further comprising:

detecting at least one attribute of the portion of the bronchial tree; and

evaluating whether the nerve tissue is damaged based on the detection of the at least one attribute.

15. A method of treating a subject, the method comprising:

moving an elongate assembly along a lumen of an airway of a bronchial tree, the airway including a first tubular section, a second tubular section, a treatment site between the first tubular section and the second tubular section, and a nerve trunk extending along at least the first tubular section, the treatment site, and the second tubular section; and

damaging a portion of the nerve trunk at the treatment site to substantially prevent signals from traveling between the first tubular section and the second tubular section via the nerve trunk.

16. The method of claim 15, further comprising:

allowing blood flow between the first tubular section and the second tubular section while damaging the portion of the nerve trunk.

17. The method of claim 15, wherein damaging the portion of the nerve trunk causes dilation of the second tubular section of the airway.

18. The method of claim 15, wherein damaging the portion of the nerve trunk causes a decrease of parasympathetic nervous system input to the second tubular section while not damaging to any significant extent a network of arteries extending between the first tubular section and the second tubular section.

19. The method of claim 15, further comprising:

moving a distal end of the elongate assembly at least partially through a wall of the airway such that an ablation element of the elongate assembly is positioned to damage the portion of the nerve trunk when the ablation element is activated.

20. A method for decreasing resistance to airflow within a bronchial tree of a subject, the method comprising:

moving an intraluminal device along a lumen of an airway of a bronchial tree; and

at least partially denervating a portion of the bronchial tree using the intraluminal device without irreversibly damaging to any significant extent an inner surface of the airway, the inner surface defining the lumen.

21. The method of claim 20, wherein denervating the portion of the bronchial tree comprises destroying at least one nerve trunk at a position that is within at least one of the left and right lung root and proximate to one lung of the subject.

22. The method of claim 20, wherein denervating the portion of the bronchial tree comprises destroying at least one nerve trunk at a position that is within a left lung or a right lung.

23. The method of claim 20, wherein denervating the portion of the bronchial tree comprises destroying at least one nerve trunk adjacent to the airway without destroying at least one artery adjacent to the airway.

24. The method of claim 20, wherein the portion of the bronchial tree is denervated without permanently damaging to a significant extent smooth muscle in a wall of the airway.

25. The method of claim 20, wherein denervating the portion of the bronchial tree includes damaging substantially all nerve trunks extending along a tubular section of the airway so as to prevent substantially all nervous system signals transmitted along the airway from traveling past the denervated portion.

26. The method of claim 20, wherein denervating the portion of the bronchial tree comprises damaging afferent nerves so as to attenuate signals traveling along the afferent nerves.

27. The method of claim 20, wherein denervating the portion of the bronchial tree comprises damaging efferent nerves so as to attenuate signals traveling along the efferent nerves.

28. The method of claim 20, wherein denervating the portion of the bronchial tree includes damaging at least one of a vagus nerve and a portion of a nerve trunk connected to a vagus nerve.

29. The method of claim 20, wherein denervating the portion of the bronchial tree comprises at least one of heating the nerve tissue, cooling the nerve tissue, and delivering fluid that traumatizes the nerve tissue.

30. The method of claim 20, wherein denervating the portion of the bronchial tree comprises at least one of puncturing the nerve tissue along the airway, tearing the nerve tissue along the airway, and cutting the nerve tissue along the airway.

31. The method of claim 20, wherein denervating the portion of the bronchial tree comprises at least one of applying radiofrequency energy to the nerve tissue along the airway, applying ultrasound energy to the nerve tissue along the airway, applying ionizing radiation to the nerve tissue along the airway, and applying electrical energy to disrupt cell membranes of the nerve tissue along the airway.

32. The method of claim 20, wherein denervating the portion of the bronchial tree comprises at least one of applying radiofrequency energy to the nerve tissue along the airway while cooling the airway using an inflated balloon and an electrode carried by the balloon.

33. The method of claim 20, wherein denervating the portion of the bronchial tree comprises delivering one or more long acting nerve blocking chemicals to nerve tissue along the airway.

34. The method of claim 20, further comprising:

positioning a delivery assembly within the airway, the delivery assembly carrying the intraluminal device prior to moving the intraluminal device, and wherein moving the intraluminal device includes passing a distal tip of the intraluminal device out of the delivery assembly before denervating the portion of the bronchial tree using the distal tip.

35. The method of claim 34, further comprising:

viewing the airway using the delivery assembly.

36. The method of claim 20, wherein denervating the portion of the bronchial tree includes:

embedding at least a portion of the intraluminal device in a wall of the airway such that an ablation element of the intraluminal device is proximate to nerve trunk tissue; and

ablating the nerve tissue using the ablation element.

37. The method of claim 20, wherein denervating the portion of the bronchial tree causes decreased mucus production.

38. The method of claim 20, wherein denervating the portion of the bronchial tree causes a sufficient decrease of airway smooth muscle tone so as to substantially increase airflow into and out of a lung of the subject.

39. The method of claim 20, wherein denervating the portion of the bronchial tree leads to a decrease in reflex contraction of smooth muscle of the airway.

40. The method of claim 20, wherein denervating the portion of the bronchial tree leads to decreased mucus production.

41. The method of claim 40, wherein the decreased mucus production causes a substantial increase in airflow into and out of a lung.

42. The method of claim 40, wherein the decreased mucus production results in a decreased frequency of coughing.

43. A method comprising:

denervating most of a portion of a bronchial tree in a lung to substantially prevent nervous system signals from traveling to substantially all bronchial branches of the portion of the bronchial tree.

44. The method of claim 43, wherein denervating most of the portion includes damaging nerve tissue positioned along a main bronchus to substantially prevent nervous system signals from traveling to substantially all distal bronchial branches connected to and distal to the main bronchus.

45. The method of claim 43, wherein denervating most of the portion includes ablating nerve tissue using less than 100 applications of energy to denervate substantially all bronchial branches in one lung.

46. The method of claim 43, wherein denervating comprises damaging nerve tissue positioned between a trachea and a lung through which the bronchial branches extend.

47. The method of claim 43, further comprising damaging nerve tissue along a main bronchus.

48. The method of claim 47, further comprising using an intraluminal treatment apparatus to damage nerve tissue of the main bronchus and to damage nerve tissue of another main bronchus without removing the intraluminal treatment apparatus from a trachea connected to the main bronchi.

49. The method of claim 43, further comprising evaluating at least one attribute of an airway of the bronchial tree.

50. The method of claim 49, wherein evaluating includes positioning a detection element distal to nerve tissue damaged during denervation.

51. The method of claim 50, wherein the detection element includes a balloon that is inflatable to contact an inner surface of an airway enabling evaluation of physical properties of the airway.

52. An elongate assembly for treating a lung, the elongate assembly adapted to damage nerve tissue of a nerve trunk so as to attenuate nervous system signals transmitted to a portion of the bronchial tree while at least a portion of the elongate assembly extends along a lumen of an airway of the bronchial tree.

53. The elongate assembly of claim 52, further comprising an ablation element adapted to ablate the nerve tissue without destroying smooth muscle in a wall of the airway.

54. The elongate assembly of claim 52, further comprising a distal tip configured to pierce tissue of the airway, the distal tip including an ablation element for ablating the nerve tissue.

55. The elongate assembly of claim 52, further comprising an ablation assembly comprising an energy source and an expandable member carrying the energy source, the energy source adapted to output at least one of radiofrequency energy, ultrasound energy, ionizing radiation, and electrical energy.

56. The elongate assembly of claim 52, further comprising an output element capable of outputting at least one of radiofrequency energy, ultrasound energy, ionizing radiation, and electrical energy.

57. A system for treating a subject, the system comprising an elongate assembly dimensioned to move along a lumen of an airway of a bronchial tree, the elongate assembly adapted to attenuate signals transmitted by nerve tissue while not irreversibly damaging to any significant extent an inner surface of the airway.

58. The system of claim 57, wherein the elongate assembly includes an embeddable distal tip, the distal tip including an ablation element adapted to ablate the nerve tissue.

59. The system of claim 58, wherein the ablation element comprises an electrode operable to output radiofrequency energy.

60. The system of claim 57, wherein the elongate assembly has a distal tip configured to penetrate a wall of the airway such that an ablation element of the distal tip is moved next to a portion of the nerve tissue located at an outer periphery bronchial tree.

61. The system of claim 57, wherein the elongate assembly comprises a plurality of radially deployable ablation assemblies that carry one or more tissue ablation elements.

62. The system of claim 57, further comprising:

an intraluminal delivery assembly having a delivery lumen for receiving the elongate assembly.

63. The system of claim 62, wherein the intraluminal delivery assembly is a bronchoscope.

64. The system of claim 57, wherein the elongate assembly is further adapted to attenuate signals transmitted by nerve tissue without destroying a significant portion of smooth muscle in a wall of the airway.

65. The system of claim 57, wherein the elongate assembly includes an inflatable balloon and an electrode coupled to the balloon, the electrode adapted to output a sufficient amount of energy to cause attenuation of the signals transmitted by the nerve tissue.

66. The system of claim 65, wherein the electrode extends circumferentially about the balloon and is coupled to an outer surface of the balloon.

67. The system of claim 65, wherein the elongate assembly includes an inlet proximate one end of the balloon and an outlet proximate another end of the balloon such that the fluid flowing through the inlet flows through the balloon and out of the outlet.