Methods and apparatus to achieve a closure of a layered tissue defect

• US 20060271030A1
• Filed: 04/11/2006
• Published: 11/30/2006
• Est. Priority Date: 04/11/2005
• Status: Abandoned Application

• Current Assignee: Terumo Kabushiki Kaisha
• Original Assignee: Cierra, Inc. (Terumo Corporation)
• Inventors: Horne, Kenneth, Francis, Dan, Alejandro, Jose, Filloux, Dominique, Kumar, Uday N., Engelson, Erik, Taimisto, Miriam H., Sutton, Doug, Uchida, Andy, Kim, Lucia
• Application Number:
  US11/403,038
• Publication Number:
  US 20060271030A1
• Time in Patent Office: Days
• US Class Current: 606/27
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 2017/00504 Tissue welding
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/0063 Sealing
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1054 having detachable or disposable balloons
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

Methods for treating anatomic tissue defects such as a patent foramen ovate generally involve positioning a distal end of a catheter device at the site of the defect, exposing a housing and energy transmission member from the distal end of the catheter, engaging the housing with tissues at the site of the defect, applying suction or other approximating tool to the tissue via the housing to bring the tissue together, and applying energy to the tissue with the energy transmission member or to deliver a clip or fixation device to substantially close the defect. Apparatus generally include a catheter body, a housing extending from a distal end of the catheter body for engaging tissue at the site of the defect, and further adapted to house a fusing or fixation device such as an energy transmission member adjacent a distal end of the housing, or a clip or fixation delivery element.

Claims

1. An apparatus for fusing a layered tissue structure, the apparatus comprising:

a catheter body having a proximal end and a distal end;

a housing on a distal portion of the catheter body, the housing adapted to appose tissue and having an inside volume;

an energy transmission member positioned within the housing; and

means on the housing to facilitate the housing to expand and/or collapse thereby changing the inside volume of the housing.

2. An apparatus as in claim 1, wherein the housing has a shape adapted to effectively cover and appose a layered tissue structure.

3. An apparatus as in claim 2, wherein the housing shape comprises a nose protruding from the housing.

4. An apparatus as in claim 1, wherein the housing is resilient.

5. An apparatus as in claim 1, wherein the housing comprises one or more hinged joints.

6. An apparatus as in claim 1, wherein the housing is adapted to maintain its shape sufficiently to maintain a flow of suction within the housing.

7. An apparatus as in claim 1, wherein the means comprises a structure over an exterior lip of the housing surrounding an opening in the housing.

8. An apparatus as in claim 6, wherein the housing is collapsible into a small diameter introducer sheath.

9. An apparatus as in claim 8, wherein the housing is collapsible into a 16F sheath or smaller.

10. An apparatus as in claim 8, wherein the housing has an electrode sized to treat a patent foramen ovale up to 30 mm in diameter, and wherein the electrode is collapsible into a 16F sheath or smaller.

11. An apparatus as in claim 1, wherein the means comprises a reinforcement in a roof of the housing and the reinforcement inhibits the housing from substantially collapsing and facilitates the housing to maintain its shape sufficiently to maintain a flow of suction within the housing, while the housing is apposed to the tissue structure and a vacuum is applied to the inside volume.

12. An apparatus as in claim 11, wherein the reinforcement comprises a thickened region, a hardened region, or a stiffening element.

13. An apparatus as in claim 11, wherein the reinforcement comprises a metal structure spanning at least a portion of the roof.

14. An apparatus as in claim 1, wherein the means comprises a ring circumscribing at least a portion of the housing.

15. An apparatus as in claim 14, wherein the ring circumscribes a midpoint of the housing.

16. An apparatus as in claim 14, wherein the ring defines a lower flange in the housing.

17. An apparatus as in claim 14, wherein the ring circumscribes the lower portion of the inside volume.

18. An apparatus as in claim 1, wherein fluid flow is a means to assist in expansion of the housing.

19. An apparatus as in claim 1, wherein an electrode is a means to facilitate the housing to expand.

20. An apparatus as in claim 1, further comprising a collapsing introducer adapted to collapse the housing prior to the housing being slidably disposed into an introducer sheath.

21. An apparatus as in claim 20, wherein the collapsing introducer is shorter than the catheter body.

22. An apparatus as in claim 20, wherein the collapsing introducer is shorter than the introducer sheath.

23. An apparatus as in claim 20, wherein the collapsing introducer has a length in the range from 0.5 inches to 10 inches.

24. An apparatus for fusing a layered tissue structure, the apparatus comprising:

a catheter body having a proximal end and a distal end;

a housing on a distal portion of the catheter body;

an energy transmission member positioned within the housing; and

means associated with the housing for apposing the layered tissue structure to engage the housing against the layered tissue structure.

25. An apparatus as in claim 24, wherein the means comprises a clamp contained within the housing which is deployed in response to the application of a vacuum to the housing.

26. An apparatus as in claim 25, wherein the clamp comprises structure of the housing which collapses the housing walls to grasp tissue when the vacuum is applied.

27. An apparatus as in claim 24, wherein the means comprises a movable element in the housing adapted to capture the layered tissue between the movable element and a portion of the housing.

28. An apparatus as in claim 24, wherein the means comprises a vacuum applied to the housing.

29. An apparatus as in claim 28, wherein the vacuum is applied circumferentially to the housing.

30. An apparatus as in claim 24, wherein the means comprises a movable element having a plurality of apertures adapted to capture the layered tissue upon application of a vacuum.

31. An apparatus as in claim 30, further comprising a second element disposed in the housing and having a plurality of apertures, wherein the layered tissue is captured between the first movable element and the second element.

32. An apparatus as in claim 24, wherein the means comprises a clamp adapted to penetrate the tissue structure and engage a rear side of the tissue structure while the housing engages a front side of the tissue structure.

33. An apparatus as in claim 25, wherein the clamp comprises a penetrating tube and a deployable anchor.

34. An apparatus as in claim 33, wherein the deployable anchor comprises a coil.

35. An apparatus as in claim 25, wherein the clamp comprises at least one magnetic element to provide a clamping force.

36. An apparatus as in claim 35, wherein the magnetic element comprises a permanent magnet.

37. An apparatus as in claim 35, wherein the magnetic element comprises an electromagnet.

38. An apparatus as in claim 24, wherein the opposing means comprises at least one gripper on the housing which engages the tissue when a vacuum is applied through the housing.

39. An apparatus as in claim 24, wherein the means comprises a movable vacuum tube contained within the housing adapted to pull layered tissue toward the housing and against an element disposed on the housing having a plurality of apertures.

40. An apparatus as in claim 24, wherein the means comprises an elongate member having a deployable anchor.

41. An apparatus as in claim 24, wherein the deployable anchor comprises a pivotable puncture tube.

42. An apparatus as in claim 24, further comprising a collapsing introducer adapted to collapse the housing prior to slidably disposing the housing into an introducer sheath.

43. An apparatus as in claim 42, wherein the collapsing introducer is shorter than the catheter body.

44. An apparatus as in claim 42, wherein the collapsing introducer is shorter than the introducer sheath.

45. An apparatus as in claim 42, wherein the collapsing introducer has a length in the range from 0.5 inches to 10 inches.

46. An apparatus for fusing a layered tissue structure, the apparatus comprising:

a catheter body having a proximal end and a distal end;

a housing on a distal portion of the catheter body; and

an energy transmission member positioned within the housing, wherein the energy transmission is adapted to engage and appose tissue.

47. An apparatus as in claim 46, wherein the member comprises jaws.

48. An apparatus as in claim 47, wherein the jaws are bipolar electrodes.

49. An apparatus as in claim 46, wherein the member comprises a ring which can snare tissue.

50. An apparatus as in claim 49, wherein the ring is a return electrode.

51. An apparatus as in claim 46, wherein the member comprises a tissue-penetrating electrode.

52. An apparatus as in claim 51, wherein the tissue-penetrating electrode includes a distal anchor to allow the electrode to be pulled back to appose the layered tissue structure.

53. An apparatus as in claim 52, wherein the housing is a return electrode.

54. An apparatus as in claim 46, further comprising a collapsing introducer adapted to collapse the housing prior to slidably disposing the housing into an introducer sheath.

55. An apparatus as in claim 54, wherein the collapsing introducer is shorter than the catheter body.

56. An apparatus as in claim 54, wherein the collapsing introducer is shorter than the introducer sheath.

57. An apparatus as in claim 54, wherein the collapsing introducer has a length in the range from 0.5 inches to 10 inches.

58. A system for fusing layered tissue structures, the system comprising:

a catheter body having a proximal end and a distal end;

a housing on a distal portion of the catheter body;

an introducer sheath slidably disposed over at least a portion of the catheter body and having a main body, a proximal end and a distal end; and

an energy transmission member positioned within the housing.

59. A system as in claim 58, wherein the energy transmission member and the housing are collapsible and slidably movable relative to the introducer sheath, from a collapsed position within the introducer sheath to an expanded position beyond the distal end of the introducer sheath.

60. A system as in claim 59, wherein the introducer sheath has a softer durometer distal tip than the introducer sheath main body and the softer durometer distal tip facilitates movement of the housing and the energy transmission member from the expanded position to the collapsed position within the introducer sheath.

61. A system as in claim 60, wherein the softer durometer distal tip is integral with the main body.

62. A system as in claim 60, wherein the softer durometer distal tip is fixedly connected to the main body.

63. A system as in claim 58, wherein the introducer sheath comprises a valve adapted to accommodate the housing and wherein the valve minimizes blood loss from the introducer sheath.

64. A system as in claim 63, wherein the valve is a hemostasis valve.

65. A system as in claim 64, wherein the hemostasis valve comprises one or more valve membranes having a top surface and a bottom surface, and wherein both the top surface and the bottom surfaces are scored.

66. A system as in claim 65, wherein the scoring comprises two orthogonal lines.

67. A system as in claim 65, wherein the valve membrane is a disk.

68. A system as in claim 58, further comprising a collapsing introducer adapted to collapse the housing prior to slidably disposing the housing into the introducer sheath.

69. A system as in claim 68, wherein the collapsing introducer is shorter than the catheter body.

70. A system as in claim 68, wherein the collapsing introducer is shorter than the introducer sheath.

71. A system as in claim 68, wherein the collapsing introducer has a length in the range from 0.5 inch to 10 inches.

72. A method for fusing apposed layered tissue structures, the method comprising:

positioning a closure device at a first treatment site having a first layer of tissue and a second layer of tissue;

approximating the layers of tissue; and

applying energy from the closure device to the apposed layers of tissue thereby fusing the apposed layers of tissue.

73. A method as in claim 72, further comprising electrophysiological monitoring of the layered tissue and adjacent tissue to minimize creation of aberrant conductive paths.

74. A method as in claim 72, further comprising minimizing energy delivery.

75. A method as in claim 72, further comprising minimizing surface area of an active electrode.

76. A method for closing a layered tissue structure, the method comprising:

implanting a first magnetic material on one side of the structure; and

implanting a second magnetic material on an opposed side of the structure;

wherein the magnetic materials create a magnetic force which compresses the layered tissue structure.

77. A method as in claim 76, wherein the layered tissue structure is a patent foramen ovale.