Methods and devices for use in performing pulmonary procedures

• US 6,679,264 B1
• Filed: 03/04/2000
• Issued: 01/20/2004
• Est. Priority Date: 03/04/2000
• Status: Expired due to Term

• Current Assignee: Pulmonx Corp.
• Original Assignee: Emphasys Medical, Inc. (Pulmonx Corp.)
• Inventors: Deem, Mark E., French, Ronald, Sutton, Douglas, Gifford, Hanson S. III
• Primary Examiner(s): Lewis, Aaron J.
• Application Number:
  US09/519,735
• Time in Patent Office: 1,417 Days
• Field of Search: 128/200.26, 128/207.14, 128/207.15, 128/207.16, 128/912, 128/200.24, 623/9, 600/104
• US Class Current: 128/207.16
• 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 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/043 Bronchi
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: F16K 15/147 : the closure elements having specially formed slits or being of an elongated easily collapsible form
• CPC Class Codes: Y10S 128/912 : Connections and closures for tubes delivering fluids to or from the body

Abstract

Systems, methods and devices for performing pulmonary procedures, and in particular treating lung disease. A flow control element includes a valve that prevents airflow in the inhalation direction but permits airflow in the exhalation direction. The flow control element is guided to and positioned at the site by a bronchoscope that is introduced into the patient'"'"'s trachea and used to view the lungs during delivery of the flow control element. The valve may include one, two or more valve elements, and it may be collapsible for easier delivery. A source of vacuum or suction may be used to increase the amount of fluid withdrawn from the lung tissue. A device for measuring hollow structures, such as bronchioles, and a device for removing a previously-placed flow control element are disclosed as well.

Claims

1. A method for treating a patient'"'"'s lung, the method comprising steps of:

(a) providing a flow control element which allows fluid flow in a first direction and limits fluid flow in a second direction, wherein the providing step is carried out by providing a valve configured to pump fluid in the first direction, the valve having a proximal valve portion, a distal valve portion, and a pumping chamber positioned between the proximal and distal valve portions;

(b) positioning the flow control element at a desired location in a lung of a patient with the first direction corresponding to an exhalation direction and the second direction corresponding to an inhalation direction.

2. The method of claim 1, wherein the positioning step is carried out by delivering the valve to the desired location in the lungs via the patient'"'"'s trachea.

3. The method of claim 2, wherein the positioning step is carried out by delivering the valve through an introducer positioned in the patient'"'"'s trachea.

4. The method of claim 3, wherein the introducer comprises a bronchoscope having at least one working channel and a lens for visualizing a target site, and wherein the positioning step is carried out by introducing a delivery device supporting the valve into the working channel of the bronchoscope.

5. The method of claim 1, further comprising the step of removing the valve subsequent to carrying out the positioning step.

6. The method of claim 1, further comprising, prior to carrying out the positioning step, determining the approximate size of the desired location.

7. The method of claim 6, wherein the determining step is carried out using a measuring device, and further comprising selecting an appropriately sized flow control element based at least in part on the determined size of the location.

8. The method of claim 7, wherein the measuring device comprises means for determining an internal dimension of a bronchiole.

9. The method of claim 1, wherein the valve is selected from the group consisting of duckbill, flapper, tricuspid, ball and needle valves.

10. The method of claim 1, further comprising the step of applying suction to at least part of the lung downstream of the valve.

11. The method of claim 10, wherein the suction is applied intermittently.

12. The method of claim 11, wherein the valve is delivered through a working channel of a bronchoscope, and the suction is applied through another channel of the bronchoscope.

13. A method for treating a patient'"'"'s lung, the method comprising steps of:

(a) providing a flow control element which limits fluid flow in at least one direction;

(b) positioning the flow control element at a location in a lung of a patient with the one direction substantially corresponding to an inhalation direction; and

(c) removing the flow control element.

14. The method of claim 13, wherein the providing step is carried out by providing a flow control element that blocks fluid flow in the one direction while allowing fluid flow in another direction, and wherein the other direction corresponds to an exhalation direction.

15. The method of claim 13, wherein the removing step is carried out by removing the flow control element after a predetermined period of time.

16. The method of claim 15, wherein the positioning step is carried out by introducing the flow control element through an introducer, the introducer having a first lumen through which the element is delivered to the location in the lung.

17. The method of claim 16, wherein the introducer comprises a bronchoscope and the first lumen corresponds to a working channel of the bronchoscope, and the positioning step is carried out by delivering the flow control element through the working channel.

18. The method of claim 13, wherein the providing step is carried out by providing a one-way valve that allows unimpeded fluid flow in the one direction and completely blocks fluid flow in the other direction.

19. The method of claim 13, further comprising the step of applying suction to a portion of the lung located downstream of the valve.

20. The method of claim 13, wherein the providing step is carried out by providing a valve configured to pump fluid in the one direction.

21. The method of claim 13, further comprising the step of determining a size of the location in the lung prior to performing the positioning step.

22. A system for treating a patient'"'"'s lung, the system comprising:

a measuring device for determining the approximate size of a hollow structure in a patient'"'"'s lung, wherein the measuring device has a flexible shaft and at least one flexible measuring element that is moved into contact with the hollow structure; and

a flow control element sized and configured to be positioned in a hollow structure located in a patient'"'"'s lung, wherein the flow control element allows fluid flow in a first direction and controls fluid flow in a second direction.

23. The system of claim 22, further comprising a plurality of different size flow control elements adapted to be placed in different size hollow structures.

24. A system for treating a patient'"'"'s lung, the system comprising:

a flow control element sized and configured to be positioned in a hollow structure located in a patient'"'"'s lung, wherein the flow control element allows fluid flow in a first direction and controls fluid flow in a second direction; and

a removal device for removing the flow control element from the hollow structure subsequent to positioning the flow control element in the hollow structure.

25. The system of claim 24, wherein the flow control element is configured to at least substantially prevents fluid flow in the second direction, and the removal device includes at least one grasping element configured to grasp the exterior of the flow control element.

26. A method for treating a patient'"'"'s lung, the method comprising steps of:

providing a flow control element which restricts fluid flow in at least a first direction, the flow control element being releasably coupled to a delivery device, wherein the delivery device has a sheath;

placing an introducer in a bronchial passageway of a patient'"'"'s lung;

inserting a bronchial access device through the introducer, the bronchial access device having a first channel and a second channel;

positioning the delivery device in the second channel; and

deploying the flow control element at the treatment site, the deploying step comprising moving the sheath relative to the flow control element.

27. The method of claim 26, further comprising visualizing a treatment site in the patient'"'"'s lung through the first channel.

28. The method of claim 26, wherein the bronchial access device comprises a bronchoscope.

29. The method of claim 26, wherein the flow control element restricts flow in only the first direction.

30. The method of claim 29, wherein the flow control element comprises a valve.

31. The method of claim 30, wherein the valve is selected from the group consisting of duckbill, flapper, tricuspid, ball and needle valves.

32. The method of claim 26, wherein at least a portion of the flow control element has a first diameter before the deploying step and a second diameter when deployed at the treatment site, the first diameter being less than the second diameter.

33. The method of claim 32, wherein the flow control element comprises a stent, and wherein during the deploying step the stent expands from the first diameter to the second diameter.

34. The method of claim 26, wherein the flow control element is advanced through the second channel during the positioning step.

35. The method of claim 26, wherein the delivery device is positioned in the second channel after the inserting step.

36. The method of claim 26, further comprising visualizing the flow control element through the first channel during the step of deploying.

37. The method of claim 26, wherein the bronchial access device includes a camera.

38. The method of claim 26, wherein the visualizing step comprises transmitting light through a lens.

39. The method of claim 26, further comprising placing an introducer in the bronchial passageway, the inserting step comprising inserting the bronchial access device through the introducer.

40. The method of claim 26, wherein the inserting step comprises positioning a distal end of the bronchial access device in a first bronchial passageway and the deploying step comprises placing the flow control element at a second bronchial passageway branching from the first bronchial passageway.

41. The method of claim 26, further comprising, prior to carrying out the deploying step, determining the approximate size of the treatment site, and selecting an appropriately sized flow control element based at least in part on the determined size of the treatment site.

42. The method of claim 41, wherein the determining step is carried out using a measuring device.

43. The method of claim 42, wherein the measuring device is introduced through the second channel.

44. The method of claim 26, further comprising the step of applying suction to at least part of the lung located distally of the flow control element.

45. A method for treating a patient'"'"'s lung, the method comprising steps of:

providing a flow control element which restricts fluid flow in at least a first direction, the flow control element being releasably coupled to a delivery device;

placing an introducer in a bronchial passageway of a patient'"'"'s lung;

inserting a bronchial access device through the introducer, the bronchial access device having a first channel and a second channel;

positioning the delivery device in the second channel; and

deploying the flow control element at the treatment site.

46. The method of claim 45, further comprising visualizing a treatment site in the patient'"'"'s lung through the first channel.

47. The method of claim 45, wherein the bronchial access device comprises a bronchoscope.

48. The method of claim 45, wherein the flow control element restricts flow in only the first direction.

49. The method of claim 48, wherein the flow control element comprises a valve.

50. The method of claim 49, wherein the valve is selected from the group consisting of duckbill, flapper, tricuspid, ball and needle valves.

51. The method of claim 45, wherein at least a portion of the flow control element has a first diameter before the deploying step and a second diameter when deployed at the treatment site, the first diameter being less than the second diameter.

52. The method of claim 51, wherein the flow control element comprises a stent, and wherein during the deploying step the stent expands from the first diameter to the second diameter.

53. The method of claim 45, wherein the flow control element is advanced through the second channel during the positioning step.

54. The method of claim 45, wherein the delivery device is positioned in the second channel after the inserting step.

55. The method of claim 45, further comprising visualizing the flow control element through the first channel during the step of deploying.

56. The method of claim 45, wherein the bronchial access device includes a camera.

57. The method of claim 45, wherein the visualizing step comprises transmitting light through a lens.

58. The method of claim 45, wherein the inserting step comprises positioning a distal end of the bronchial access device in a first bronchial passageway and the deploying step comprises placing the flow control element at a second bronchial passageway branching from the first bronchial passageway.

59. The method of claim 45, further comprising, prior to carrying out the deploying step, determining the approximate size of the treatment site, and selecting an appropriately sized flow control element based at least in part on the determined size of the treatment site.

60. The method of claim 59, wherein the determining step is carried out using a measuring device.

61. The method of claim 60, wherein the measuring device is introduced through the second channel.

62. The method of claim 45, further comprising the step of applying suction to at least part of the lung located distally of the flow control element.

63. A method for treating a patient'"'"'s lung, the method comprising steps of:

providing a flow control element which restricts fluid flow in at least a first direction, the flow control element being releasably coupled to a delivery device;

inserting a bronchial access device in a bronchial passageway of a patient'"'"'s lung, the bronchial access device having a first channel and a second channel;

positioning the delivery device in the second channel;

deploying the flow control element at the treatment site;

prior to carrying out the deploying step, determining the approximate size of the treatment site using a measuring device, wherein the measuring device is introduced through the second channel; and

selecting an appropriately sized flow control element based at least in part on the determined size of the treatment site.

64. The method of claim 63, further comprising visualizing a treatment site in the patient'"'"'s lung through the first channel.

65. The method of claim 63, wherein the bronchial access device comprises a bronchoscope.

66. The method of claim 63, wherein the flow control element restricts flow in only the first direction.

67. The method of claim 66, wherein the flow control element comprises a valve.

68. The method of claim 67, wherein the valve is selected from the group consisting of duckbill, flapper, tricuspid, ball and needle valves.

69. The method of claim 64, wherein at least a portion of the flow control element has a first diameter before the deploying step and a second diameter when deployed at the treatment site, the first diameter being less than the second diameter.

70. The method of claim 68, wherein the flow control element comprises a stent, and wherein during the deploying step the stent expands from the first diameter to the second diameter.

71. The method of claim 63, wherein the flow control element is advanced through the second channel during the positioning step.

72. The method of claim 63, wherein the delivery device is positioned in the second channel after the inserting step.

73. The method of claim 63, further comprising visualizing the flow control element through the first channel during the step of deploying.

74. The method of claim 63, wherein the bronchial access device includes a camera.

75. The method of claim 63, wherein the visualizing step comprises transmitting light through a lens.

76. The method of claim 63, wherein the inserting step comprises positioning a distal end of the bronchial access device in a first bronchial passageway and the deploying step comprises placing the flow control element at a second bronchial passageway branching from the first bronchial passageway.

77. The method of claim 63, further comprising the step of applying suction to at least part of the lung located distally of the flow control element.