Closure devices, related delivery methods, and related methods of use

• US 20060009800A1
• Filed: 09/07/2004
• Published: 01/12/2006
• Est. Priority Date: 04/11/2003
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: Velocimed PFO, Inc. (Abbott Laboratories)
• Inventors: Blaeser, David J., Haarstad, Philip J., Olson, Scott A., Anderson, Edward J., Christianson, Mark R., Wahr, Dennis W., Krone, Douglas J.
• Granted Patent: US 8,372,112 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• 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 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal

Abstract

A device for sealing a patent foramen ovale (PFO) in the heart is provided. The device includes a left atrial anchor adapted to be placed in a left atrium of the heart, a right atrial anchor adapted to be placed in a right atrium of the heart, and an elongate member adapted to extend through the passageway and connect the left and right atrial anchors. A system for delivering the closure device includes side-by-side tubes. A device for retrieving a mis-deployed closure device includes a shaft portion and an expandable retrieval portion.

Claims

1. An assembly for sealing a passageway in a heart, the assembly comprising:

a closure device for sealing a passageway in a heart including a first anchor adapted to be placed proximate a first end of the passageway, a second anchor adapted to be placed proximate a second end of the passageway, and a flexible elongate member adapted to extend through the passageway and connect the first and second anchors, the second anchor capable of movement relative to the elongate flexible member to vary a length of the elongate member between the first and second anchors; and

a delivery system for delivering the closure device to the passageway in the heart, the delivery system being configured to move within a lumen of a guide catheter and including a wire configured to control movement of the second anchor along the flexible elongate member.

2. The assembly of claim 1, wherein the passageway is a patent foramen ovale.

3. The assembly of claim 1, wherein the closure device further includes a lock movable on the flexible elongate member.

4. The assembly of claim 1, wherein the delivery system further includes a lock tube configured to move a lock along the flexible elongate member to a position adjacent the second anchor.

5. The assembly of claim 1, wherein the delivery system further includes a wire tube through which the wire extends.

6. The assembly of claim 1, wherein a portion of the wire is configured to engage the second anchor.

7. The assembly of claim 6, wherein the portion of the wire configured to engage the second anchor is a loop portion.

8. The assembly of claim 1, wherein the delivery system further includes a handle, and wherein at least a portion of the handle is connected to a portion of the wire to facilitate release of the second anchor from a portion of the wire.

9. The assembly of claim 4, wherein the delivery system further includes a handle, and wherein an actuatable portion of the handle is connected to a portion of the lock tube to control movement of the lock tube.

10. The assembly of claim 1, wherein the delivery system further includes a handle, and wherein an actuatable portion of the handle is connected to the wire to control movement of the wire.

11. The assembly of claim 1, further including a recapture device configured to engage the first and second anchors when the first and second anchors are deployed outside of the lumen of the guide catheter and within a chamber of the heart, the recapture device having an expanded configuration and a collapsed configuration.

12. The assembly of claim 11, wherein the recapture device includes a shaft portion and a retrieval portion, and wherein the retrieval portion is movable between the expanded configuration and the collapsed configuration.

13. A method of sealing a passageway in a heart, comprising:

advancing a first anchor out of a lumen of a guide catheter;

placing the first anchor proximate a first end of the passageway;

advancing a second anchor out of the lumen of the guide catheter;

controlling movement of the second anchor relative to the first anchor along a flexible elongate member disposed between the first and second anchors, wherein controlling movement of the second anchor includes varying a distance between the first and second anchors; and

placing the second anchor proximate a second end of the passageway.

14. The method of claim 13, wherein advancing the first anchor includes pushing the first anchor with the second anchor.

15. The method of claim 13, further comprising moving a lock toward the second anchor.

16. The method of claim 15, wherein moving the lock toward the second anchor includes pushing the lock along the flexible elongate member with a lock tube.

17. The method of claim 16, wherein pushing the lock with the lock tube includes actuating a portion of a handle connected to the lock tube.

18. The method of claim 13, wherein controlling movement of the second anchor includes engaging the second anchor with a portion of a wire.

19. The method of claim 18, wherein the wire includes a loop, and wherein engaging the second anchor with a portion of the wire includes engaging the second anchor with the loop.

20. The method of claim 19, further comprising releasing the second anchor from the loop.

21. The method of claim 20, wherein releasing the second anchor includes actuating a portion of a handle connected to the wire.

22. The method of claim 13, wherein varying the distance between the first and second anchors includes increasing the distance between the anchors.

23. The method of claim 13, wherein varying the distance between the first and second anchors includes decreasing the distance between the anchors.

24. The method of claim 13, wherein varying the distance between the first and second anchors includes both increasing and decreasing the distance between the anchors.

25. The method of claim 13, wherein varying the distance between the first and second anchors includes moving the second anchor in a distal direction along the flexible elongate member.

26. The method of claim 13, wherein varying the distance between the first and second anchors includes moving the second anchor in a proximal direction along the flexible elongate member.

27. The method of claim 13, wherein varying the distance between the first and second anchors includes moving the second anchor in both a distal direction and a proximal direction along the flexible elongate member.

28. A method of retrieving a closure device mis-deployed in a chamber in a heart, comprising:

advancing a retrieval device through a lumen of a guide catheter and into the chamber of the heart containing a closure device having first and second anchors and a flexible member connecting the first and second anchors;

expanding a retrieval portion of the retrieval device from a collapsed configuration to an expanded configuration;

moving the first and second anchors of the closure device into the retrieval portion;

moving the retrieval portion and the closure device within the retrieval portion toward the guide catheter;

collapsing the retrieval portion and the closure device within the retrieval portion; and

withdrawing the collapsed retrieval portion and closure device from the chamber into the guide catheter.

29. The method of claim 28, wherein advancing the retrieval device through the lumen of the guide catheter includes collapsing the retrieval portion prior to introducing the retrieval device into the guide catheter.

30. The method of claim 29, wherein collapsing the retrieval portion prior to introducing the retrieval device into the guide catheter includes advancing an introducer tube over the retrieval portion.

31. The method of claim 28, further comprising inserting a threading wire having an eyelet through a lumen of the retrieval device.

32. The method of claim 31, further comprising pulling the flexible elongate member of the closure device through the eyelet and withdrawing the threading wire from the lumen of the retrieval device to pull the flexible elongate member through the lumen of the retrieval device.

33. The method of claim 28, wherein the retrieval portion comprises shape memory alloy wires, and wherein expanding the retrieval portion includes moving the retrieval portion out of the guide catheter to permit the retrieval portion to self-expand.

34. The method of claim 28, wherein moving the first and second anchors of the closure device into the retrieval portion includes pulling proximally on the flexible elongate member.

35. The method of claim 28, wherein the retrieval device includes a shaft portion connected to the retrieval portion, and wherein moving the retrieval portion and the closure device within the retrieval portion toward the guide catheter includes proximally pulling the flexible elongate member of the closure device and proximally pulling the shaft portion.

36. The method of claim 28, wherein collapsing the retrieval portion and the closure device within the retrieval portion includes pulling the retrieval portion into the lumen of the guide catheter.

37. The method of claim 28, wherein the chamber of the heart is the right atrium.

38. The method of claim 28, wherein the chamber of the heart is the left atrium.

39. The method of claim 28, wherein expanding the retrieval portion includes expanding the retrieval portion into a basket shape.

40. A retrieval device configured to capture and remove an implantable device from an area in the human body, comprising:

a proximal shaft portion; and

a distal retrieval portion connected to the proximal shaft portion and configured to enclose and contain an implantable device positioned within an area of the human body, wherein the retrieval portion is movable between a collapsed configuration and an expanded configuration, and wherein the retrieval portion is configured to move through a lumen of a guide catheter in the collapsed configuration and is configured to expand upon exiting the lumen of the guide catheter.

41. The retrieval device of claim 40, wherein the retrieval portion includes a braided funnel of wires.

42. The retrieval device of claim 40, wherein the distal retrieval portion includes a plurality of shape memory alloy wires.

43. The retrieval device of claim 40, wherein the retrieval portion is self-expanding.

44. The retrieval device of claim 42, wherein the retrieval portion is self-expanding.

45. The retrieval device of claim 42, wherein the shape memory alloy wires are nitinol.

46. The retrieval device of claim 41, wherein the wires forming the braided funnel are made from a shape memory alloy.

47. The retrieval device of claim 46, wherein the shape memory alloy wires are nitinol.

48. The retrieval device of claim 40, further including a support collar connecting the proximal shaft portion to the distal retrieval portion.

49. The retrieval device of claim 40, wherein the distal retrieval portion forms a basket in its expanded configuration.

50. The retrieval device of claim 40, wherein the implantable device is a closure device for use in the heart.

51. The retrieval device of claim 40, wherein the area of the human body is a chamber of the heart.