Method and device for left atrial appendage occlusion

• US 7,128,073 B1
• Filed: 11/08/1999
• Issued: 10/31/2006
• Est. Priority Date: 11/06/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: ev3 Endovascular, Inc. (Medtronic Plc)
• Inventors: Lesh, Michael D., De Cicco, Dino, Kriedler, Marc S., Frazier, Andrew G. C., Roue, Chad C., Khairkahan, Alex K., van der Burg, Erik J.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US09/435,562
• Time in Patent Office: 2,549 Days
• Field of Search: 606/1, 606/151, 606190-200, 606/213, 606/110, 606/113, 606/114, 606/127, 606/128, 606/159, 606/167, 606/170, 606/171, 606/108, 606/157, 627 11- 154, 627/11.11, 627/901, 627/921, 128/887
• US Class Current: 128/887
• 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 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 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/12195 comprising a curable material
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/081 : Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/1205 : Introduction devices
• CPC Class Codes: A61F 2/01 : Filters implantable into blood vessels
• CPC Class Codes: A61F 2002/018 : made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61M 2025/1054 : having detachable or disposable balloons
• CPC Class Codes: A61M 2210/125 : Heart
• 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

Disclosed is an occlusion device for use in a body lumen such as the left atrial appendage. The occlusion device includes an occlusion member and may also include a stabilizing member. The stabilizing member inhibits compression of the left atrial appendage, facilitating tissue in-growth onto the occlusion member. Methods are also disclosed.

Claims

1. A containment device for positioning at a left atrial appendage, comprising:

a proximal end, a distal end, an intermediate portion between the proximal and distal ends, and a longitudinal axis extending therethrough;

at least three supports extending between the proximal end and the distal end;

each support comprising an elongate, flexible element which is movable from a first orientation in which the element extends substantially parallel to the axis at no more than a first distance from the axis, to a second orientation in which at least a portion of the element is inclined toward the intermediate portion with respect to the axis and is separated by at least a second distance from the axis which is greater than the first distance, wherein the intermediate portion in the second orientation is sized and configured to engage a surface at the left atrial appendage and the supports in their second orientation increase radially in dimension from the proximal end to an apex portion and then decrease radially in dimension from the apex portion to the distal end; and

an endothelialization membrane carried by the device, for promoting endothelialization across the left atrial appendage,

wherein the endothelialization membrane at least in part comprises a first membrane on a first side of the supports, a second membrane on a second side of the supports, and a bonding layer for bonding the first membrane and the second membrane together.

2. A containment device as in claim 1, comprising at least five supports.

3. A containment device as in claim 1, comprising from about five supports to about twenty supports.

4. A containment device as in claim 3, further comprising at least one barb on each of at least two supports.

5. A containment device as in claim 1, further comprising a proximal hub at the proximal end and a distal hub at the distal end.

6. A containment device as in claim 5, wherein the supports and the proximal hub and the distal hub are formed from a tube.

7. A containment device as in claim 5, wherein the supports and the proximal hub and the distal hub are formed from a sheet.

8. A containment device as in claim 1, further comprising at least one barb on each support.

9. A containment device as in claim 1, wherein the supports comprise a nickel titanium alloy.

10. A containment device as in claim 1, wherein the supports comprise stainless steel.

11. A containment device as in claim 1, wherein the first and second membranes comprise ePTFE.

12. A containment device as in claim 1, wherein the first and second membranes comprise Dacron.

13. A containment device as in claim 1, where the first and second membranes comprise nylon.

14. A containment device as in claim 1, wherein the endothelialization membrane has a pore size of no greater than about 0.04 inches.

15. A containment device as in claim 1, wherein the containment device comprises a self expandable structure.

16. A containment device as in claim 15, wherein the self expandable structure comprises wire mesh.

17. A containment device as in claim 15, wherein the self expandable structure comprises braided wire.

18. A containment device as in claim 15, wherein the self expandable structure comprises wire coil.

19. A containment device as in claim 15, wherein the self expandable structure comprises shape memory material.

20. A containment device as in claim 15, wherein the self expandable structure comprises pseudoelastic alloy.

21. A containment device as in claim 15, wherein the self expandable structure comprises nickel titanium alloy.

22. A containment device as in claim 15, wherein the self expandable structure comprises stainless steel.

23. A containment device as in claim 15, wherein the self expandable structure comprises composite material.

24. A containment device as in claim 1, wherein the containment device comprises a self expandable wire structure.

25. A containment device for implantation at an opening in the body, comprising:

a support member movable from a reduced cross-section to an enlarged cross-section, the support member in the enlarged cross-section extending from a proximal end and inclining radially outward to an apex portion, and then inclining radially inward to a distal end; and

a porous endothelialization membrane carried by the support member,

wherein the endothelialization membrane at least in part comprises a first membrane on a first side of the support member, a second membrane on a second side of the support member, and a bonding layer for bonding the first membrane and the second membrane together.

26. A containment device as in claim 25, further comprising at least one hub on the support member and a plurality of spokes extending therefrom.

27. A containment device as in claim 26, wherein the support member comprises at least eight spokes.

28. A containment device as in claim 26, wherein at least one spoke has a first end and a second end, and the first end is attached to the hub.

29. A containment device as in claim 26, wherein each spoke comprises a proximal section, a distal section, and a bend in between the proximal and distal sections when the support member is in the enlarged cross-section.

30. A containment device as in claim 26, wherein the spokes are cut from a tube.

31. A containment device as in claim 26, comprising at least one barb on each spoke.

32. A containment device as in claim 26, wherein the spokes comprise a nickel titanium alloy.

33. A containment device as in claim 26, wherein the spokes comprise stainless steel.

34. A containment device as in claim 25, wherein the support member comprises wire.

35. A containment device as in claim 25, further comprising at least one tissue attachment element on the support.

36. A containment device as in claim 35, wherein the tissue attachment element comprises a tissue piercing element.

37. A containment device as in claim 25, further comprising at least one tissue attachment element on the support member.

38. A containment device as in claim 25, wherein the first and second membranes comprise ePTFE.

39. A containment device as in claim 25, wherein the first and second membranes comprises Dacron.

40. A containment device as in claim 25, where the first and second membranes comprises nylon.

41. A containment device as in claim 25, wherein the endothelialization membrane has a pore size of no greater than about 0.04 inches.

42. A containment device as in claim 25, wherein the containment device comprises a self expandable structure.

43. A containment device as in claim 42, wherein the containment device comprises a self expandable wire structure.

44. A containment device as in claim 42, wherein the self expandable structure comprises wire mesh.

45. A containment device as in claim 42, wherein the self expandable structure comprises braided wire.

46. A containment device as in claim 42, wherein the self expandable structure comprises wire coil.

47. A containment device as in claim 42, wherein the self expandable structure comprises shape memory material.

48. A containment device as in claim 42, wherein the self expandable structure comprises pseudoelastic alloy.

49. A containment device as in claim 42, wherein the self expandable structure comprises nickel titanium alloy.

50. A containment device as in claim 42, wherein the self expandable structure comprises stainless steel.

51. A containment device as in claim 42, wherein the self expandable structure comprises composite material.

52. A containment device as in claim 42, wherein the self expandable structure has at least one proximally concave surface and at least one distally concave surface when in an expanded configuration.

53. A containment device as in claim 25, wherein the bonding layer comprises a mesh.

54. A containment device as in claim 53, wherein the mesh comprises polyethylene.

55. A containment device as in claim 54, wherein the mesh has an open surface area within the range of from about 10% to about 90%.

56. A containment device as in claim 54, wherein the mesh has an open surface area within the range of from about 30% to about 60%.

57. A containment device as in claim 25, wherein the device in its enlarged cross-section has a maximum transverse dimension adapted to engage a surface at a left atrial appendage.

58. A containment device as in claim 25, wherein the apex portion is elongated in an axial direction.

59. A device for implantation within a left atrial appendage of a patient, the device comprising:

an expandable frame having a proximal end, a distal end, and a longitudinal axis extending therethrough, the frame comprising a plurality of supports;

each support comprising an elongate, flexible element, at least some of the supports being movable from a first orientation in which the element extends substantially parallel to the axis at no more than a first distance from the axis, to a second orientation in which at least a portion of the element is inclined with respect to the axis and is separated by at least a second distance from the axis which is greater than the first distance, wherein the supports in their second orientation increase radially in dimension from the proximal end to an apex portion and then decrease radially in dimension from the apex portion to the distal end; and

an endothelialization membrane attached to at least a proximal face of the device having a pore size sufficient to permit endothelialization, the proximal face of the device comprising at least in part the inclined portion of a plurality of the flexible elements and being sized and configured to block an opening to the left atrial appendage;

wherein the endothelialization membrane has a porosity in the range of about 5 to about 60 microns;

wherein the endothelialization membrane comprises a first membrane and a second membrane, wherein the first membrane and second membrane are attached to each other on opposite sides of the supports.

60. The device of claim 59, further comprising a proximal hub at the proximal end and a distal hub at the distal end.

61. The device of claim 59, wherein the supports comprise a nickel titanium alloy.

62. The device of claim 59, wherein the membrane comprises ePTFE.