Methods and devices for obstructing and aspirating lung tissue segments

• US 6,527,761 B1
• Filed: 10/27/2000
• Issued: 03/04/2003
• Est. Priority Date: 10/27/2000
• Status: Expired due to Term

• Current Assignee: Pulmonx Corp.
• Original Assignee: Pulmonx Corp.
• Inventors: Reilly, Michael P., Wondka, Tony, Kotmel, Robert, Buch, Wally S., Soltesz, Peter P.
• Primary Examiner(s): Walberg, Teresa
• Assistant Examiner(s): Fastovsky, Leonid M
• Application Number:
  US09/699,302
• Time in Patent Office: 858 Days
• Field of Search: 604/516
• US Class Current: 604/516
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22068 Centering

Abstract

Methods, systems, devices and kits for performing lung volume reduction in patients suffering from chronic obstructive pulmonary disease or other conditions using and comprising minimally invasive instruments introduced through the mouth (endotracheally) to isolate a target lung tissue segment from other regions of the lung and reduce lung volume. Isolation is achieved by deploying an obstructive device in a lung passageway leading to the target lung tissue segment. Once the obstructive device is anchored in place, the segment can be aspirated through the device. This may be achieved by a number of methods, including coupling an aspiration catheter to an inlet port on the obstruction device and aspirating through the port. Or, providing the port with a valve which allows outflow of gas from the isolated lung tissue segment during expiration of the respiratory cycle but prevents inflow of air during inspiration. In addition, a number of other methods may be used. The obstructive device may remain as an implant, to maintain isolation and optionally allow subsequent aspiration, or the device maybe removed at any time.

Claims

1. A method for lung volume reduction, said method comprising:

deploying an obstructive device in a lung passageway to a lung tissue segment; and

aspirating the segment through the deployed obstructive device to at least partially collapse the lung segment.

2. A method as in claim 1, wherein aspirating comprises coupling an aspiration catheter to the obstructive device and aspirating gas through the catheter from the segment.

3. A method as in claim 2, wherein the obstructive device comprises an inlet port, the aspiration catheter comprises an access tube and coupling comprises passing an access tube through the inlet port.

4. A method as in claim 3, wherein the inlet port comprises a self-sealing septum and coupling comprises piercing the access tube through the septum.

5. A method as in claim 4, wherein the septum comprises a solid membrane or a pre-cut membrane.

6. A method as in claim 2, wherein the obstructive device comprises a valve and coupling comprises engaging the aspiration catheter to the valve, wherein aspiration opens the valve.

7. A method as in claim 1, wherein aspirating comprises:

advancing an aspiration catheter into the lung passageway toward the obstructive device, wherein the aspiration catheter has an occlusion balloon near its distal end;

inflating the occlusion balloon to substantially occlude the lung passageway proximal to the obstructive device; and

aspirating gas through the obstructive device and the catheter.

8. A method as in claim 7, wherein the obstructive device comprises a valve and aspirating opens the valve.

9. A method as in claim 8, wherein the valve comprises a port and engaging comprises sliding a coupling member or the aspiration catheter over the port to form a seal.

10. A method as in any of claims 1, 3 or 6, wherein the obstructive device comprises a structural support and deploying comprises expanding the structural support so that it anchors in the passageway.

11. A method as in claim 10, wherein the structural support comprises a self-expanding support and expanding comprises releasing the self-expanding support from constraint so that it expands and thereby anchors in the passageway.

12. A method as in claim 11, wherein deploying further comprises inflating a balloon which expands the structural support.

13. A method as in claim 1, further comprising positioning an access catheter in the lung passageway prior to deployment of the obstruction device, said access catheter having a proximal end, a distal end, and at least one lumen extending therethrough.

14. A method as in claim 13, wherein the access catheter has an occlusion balloon near its distal end and aspirating comprises:

inflating the occlusion balloon to substantially occlude the lung passageway proximal to the obstructive device; and

aspirating gas through the obstructive device and the catheter.

15. A method as in claim 14, wherein the access catheter provides optical imaging.

16. A method as in claim 14, wherein the access catheter is steerable.

17. A method as in claim 14, wherein the access catheter is positioned with the use of a guidewire.

18. A method as in claim 17, wherein the guidewire provides imaging capabilities.

19. A method as in claim 1, further comprising introducing a gas or liquid to the segment prior to aspiration.

20. A method as in claim 19, wherein the gas comprises 100% oxygen, a Helium-Oxygen mixture or a low molecular weight gas.

21. A method as in claim 19, wherein the liquid comprises perfluorocarbon or a drug.

22. A method for lung volume reduction, said method comprising deploying a unidirectional valve within a lung passageway to a lung tissue segment, wherein the valve opens during expiration to allow outflow of gas from the lung segment and the valve closes during inspiration to prevent inflow of gas to the lung segment.

23. A method as in claim 22, wherein the unidirectional valve comprises a port covered by a flexible layer which is attached to the port by at least one point of connection.

24. A method as in claim 23, wherein at least a portion of the flexible layer moves away from the port during expiration to allow outflow of gas through the port and moves against the port during inspiration to prevent inflow of gas through the port.

25. A method as in claim 24, wherein the flexible layer is solid and outflow of gas through the port during expiration flows between the points of connection and around the edges of the flexible layer.

26. A method as in claim 24, wherein the flexible layer has holes and the port further comprises a partition having holes which are not aligned with the layer holes so that at least a portion of the flexible layer moves away from the partition during expiration to allow outflow of gas through the partition holes and the layer holes and the layer moves against the partition during inspiration to prevent inflow of gas through the holes.

27. A method as in claim 26, further comprising positioning an access catheter in the lung passageway prior to deployment of the obstructive device, said access catheter having a proximal end, a distal end, and at least one lumen extending therethrough.

28. A method as in claim 27, wherein the access catheter provides optical imaging.

29. A method as in claim 27, wherein the access catheter is steerable.

30. A method as in claim 27, wherein the access catheter is positioned with the use of a guidewire.

31. A method as in claim 30, wherein the guidewire provides imaging capabilities.

32. A method for lung volume reduction, said method comprising:

accessing a lung passageway to a lung tissue segment; and

deploying a blockage device in the passageway.

33. A method as in claim 32, wherein the blockage device comprises a structural support and a sack.

34. A method as in claim 33, wherein the structural support comprises a coil or mesh.

35. A method as in claim 33, wherein the structural support is connected to the sack.

36. A method as in claim 33, wherein the structural support is encased in the sack.

37. A method as in claim 32, wherein the blockage device comprises an inflatable member and further comprising inflating the inflatable member.

38. A method as in claim 37, wherein the inflatable member comprises a multi-layer balloon having an outer layer and an inner layer and inflation comprises injecting a first material within the inner layer.

39. A method as in claim 38, further comprising injecting a second material in an area between the inner and outer layers.

40. A method as in claim 39, wherein the outer layer has openings and injection of the second material provides flow of the second material through the openings.

41. A method as in claim 32, wherein accessing a lung passageway comprises positioning a catheter in the lung passageway.

42. A method as in claim 41, wherein the catheter is an access catheter having a proximal end, a distal end, and at least one lumen extending therethrough.

43. A method as in claim 42, wherein the access catheter provides optical imaging.

44. A method as in claim 41, wherein the access catheter is steerable.

45. A method as in claim 41, wherein the access catheter is positioned with the use of a guidewire.

46. A method as in claim 45, wherein the guidewire provides imaging capabilities.

47. A method as in claim 32, further comprising introducing 100% oxygen, Helium-Oxygen mixture or low molecular weight gas to the segment prior to deploying the blockage device in the passageway.

48. A device for obstructing and bleeding gas from a lung tissue segment, said device comprising:

an expandable structure which is deployable within a lung passageway; and

means for the expandable structure for blocking airflow in one direction therethrough and permitting airflow in the other direction therethrough.

49. A device as in claim 48, wherein the blocking means comprises a valve.

50. A device as in claim 49, wherein the valve is biased to open in response to expiration and remain closed in response to inspiration.

51. A device as in claim 49, wherein the valve is biased to open in response to an aspiration vacuum applied by an aspiration catheter.

52. A device as in claim 51, further comprising a port for selectively coupling to an aspiration catheter.

53. A device as in claim 48, wherein the blocking means comprises a self-sealing septum, wherein a penetrating element on an aspiration catheter can be selectively penetrated through the septum to draw air therethrough.

54. A device as in claim 48, wherein the expandable structure comprises superelastic, shape-memory or spring tempered wire so that the expandable structure is self-expanding.

55. A device as in claim 54, wherein the expandable structure comprises a coil.

56. A device as in claim 54, wherein the expandable structure comprises radial segments which allow the device to expand and longitudinal segments which rest against the lung passageway.

57. A system for obstructing a lung passageway to a lung tissue segment, said system comprising:

an access catheter having a proximal end, a distal end, and at least one lumen extending therethrough, and

an obstruction device deployable within the lung passageway having an inlet port adapted for aspirating the lung tissue segment through the inlet port,

wherein the obstruction device is introduceable by the access catheter.

58. A system as in claim 57, wherein the obstruction device is houseable within a lumen of the access catheter for deployment out of its distal end.

59. A system as in claim 57, wherein the obstruction device is mountable on the access catheter near its distal end.

60. A kit comprising:

an obstruction device deployable within a lung passageway; and

instructions for use according to a method of lung volume reduction comprising;

deploying an obstructive device in a lung passageway to a lung tissue segment; and

aspirating the segment through the deployed obstructive device to at least partially collapse the lung segment.

61. A kit as in claim 60, further comprising an access catheter having a proximal end, a distal end, and at least one lumen extending therethrough.

62. A kit as in claim 61, wherein the access catheter provides optical imaging.

63. A kit as in claim 60, further comprising a guidewire.

64. A kit as in claim 63, wherein the guidewire provides optical imaging.

65. A kit as in claim 60, further comprising an access tube.

66. A kit as in claim 60, further comprising an aspiration catheter.

67. A kit comprising:

an obstruction device deployable within the lung passageway; and

instructions for use according to a method of lung volume reduction comprising deploying a unidirectional valve within a lung passageway to a lung tissue segment, wherein the valve opens during expiration to allow outflow of gas from the lung segment and the valve closes during inspiration to prevent inflow of gas to the lung segment.

68. A kit comprising:

an obstruction device deployable within the lung passageway; and

instructions for use according to a method of lung volume reduction comprising;

accessing a lung passageway to a lung tissue segment; and

deploying a blockage device in the passageway.