Self centering closure device for septal occlusion

• US 7,192,435 B2
• Filed: 09/18/2003
• Issued: 03/20/2007
• Est. Priority Date: 09/18/2003
• Status: Expired due to Fees

• Current Assignee: Cardia, Inc.
• Original Assignee: Cardia, Inc.
• Inventors: Marino, Joseph A., Corcoran, Michael P.
• Primary Examiner(s): Hayes; Michael J.
• Assistant Examiner(s): Mendoza; Michael G.
• Application Number:
  US10/666,080
• Publication Number:
  US 20050065546A1
• Time in Patent Office: 1,279 Days
• Field of Search: 606/191, 606/194, 606/195, 606/198, 606/200, 606151-155, 606/213, 606/215, 606/220, 606/232
• 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 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 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014

Abstract

The present invention provides an occluder with a plurality of flexible rings that comprise a self centering mechanism to keep the occluder properly centered in a defect. The self centering mechanism is located between the left and right sides of the occluder. Because the occluder remains properly centered, the chance that portions of the aperture will be exposed is reduced and the effectiveness of the occluder is increased.

Claims

1. An occlusion device comprising:

a left side having a first set of arms;

a right side having a second set of arms, wherein the right side is spaced from and connected to the left side; and

a self centering mechanism which is laterally expandable to fill a defect, the mechanism comprising at least three rings located between the left and right sides wherein;

a first ring is connected to the left side;

a second ring is connected to the first ring; and

a third ring is connected to the second ring and to the right side.

2. The occlusion device of claim 1 wherein heat laminating is used to connect the first ring to the left side, the second ring to the first ring, the second ring to the third ring, and the third ring to the right side at laminated locations.

3. The occlusion device of claim 2 wherein the laminated locations connecting the first ring to the left side are offset from the laminated locations connecting the second ring to the first ring, the laminated locations connecting the second ring to the third ring are offset from the laminated locations connecting the first ring to the second ring, and the laminated locations connecting the third ring to the right side are offset from the laminated locations connecting the third ring to the second ring.

4. The occlusion device of claim 1 wherein the rings comprise anon-thrombogenic material.

5. The occlusion device of claim 1 wherein the rings comprise biocompatable wire.

6. An occlusion device comprising:

a left side;

a right side connected to the left side; and

a self centering mechanism comprising at least three rings located between the left and right sides wherein;

a first ring is connected to the left side;

a second ring is connected to the first ring;

a third ring is connected to the second ring and to the right side, and;

wherein sutures are used to connect the first ring to the left side, the second ring to the first ring, the second ring to the third ring, and the third ring to the right side at suture locations.

7. The occlusion device of claim 6 wherein the suture locations connecting the first ring to the left side are offset from the sutures connecting the second ring to the first ring, the sutures connecting the second ring to the third ring are offset from the sutures connecting the first ring to the second ring, and the sutures connecting the third ring to the right side are offset from the sutures connecting the third ring to the second ring.

8. An occlusion device comprising:

a left side;

a right side connected to the left side; and

a self centering mechanism which is laterally expandable to fill a defect, the mechanism comprising at least three rings located between the left and right sides wherein;

a first ring is connected to the left side;

a second ring is connected to the first ring;

a third ring is connected to the second ring and to the right side, and;

wherein the rings comprise polyvinyl alcohol foam.

9. An occlusion device comprising:

a center post;

first and second sets of arms connected to the center post, the first and second set of arms comprising at least five arms;

first and second sheets attached to the first and second sets of arms respectively; and

a self centering mechanism which is laterally expandable to fill a defect, the mechanism comprising a plurality of flexible rings wherein;

a first ring is connected to the first set of arms;

a second ring is connected to the first ring;

a third ring is connected to the second ring and to the second set of arms.

10. The occlusion device of claim 9 wherein sutures are used to connect the first ring to a left side of the occlusion device, the second ring to the first ring, the second ring to the third ring, and the third ring to a right side of the occlusion device at suture locations.

11. The occlusion device of claim 10 wherein the suture locations connecting the first ring to the first side are offset from the sutures connecting the second ring to the first ring, the sutures connecting the second ring to the third ring are offset from the sutures connecting the first ring to the second ring, and the sutures connecting the third ring to the second side are offset from the sutures connecting the third ring to the second ring.

12. The occlusion device of claim 9 wherein heat laminating is used to connect the first ring to a left side of the occlusion device, the second ring to the first ring, the second ring to the third ring, and the third ring to a right side of the occlusion device at laminated locations.

13. The occlusion device of claim 12 wherein the laminated locations connecting the first ring to the left side are offset from the laminated locations connecting the second ring to the first ring, the laminated locations connecting the second ring to the third ring are offset from the laminated locations connecting the first ring to the second ring, and the laminated locations connecting the third ring to the right side are offset from the laminated locations connecting the third ring to the second ring.

14. The occlusion device of claim 9 wherein the rings comprise polyvinyl alcohol foam.

15. The occlusion device of claim 9 wherein the rings comprise a non-thrombogenic material.

16. The occlusion device of claim 9 wherein the rings comprise biocompatable wire.

17. A method of manufacturing a self centering mechanism for an occlusion device, the method comprising:

forming a centering mechanism by attaching a first ring to a second ring and attaching the second ring to a third ring;

securing the first ring to a first interior side of the occlusion device;

securing the third ring to a second interior side of the occlusion device; and

wherein sutures are used to connect the first ring to the first interior side of an occlusion device, the second ring to the first ring, the second ring to the third ring, and the third ring to the second interior side at suture locations.

18. The method of manufacture of claim 17 wherein the suture locations connecting the first ring to the first interior side are offset from the sutures connecting the second ring to the first ring, the sutures connecting the second ring to the third ring are offset from the sutures connecting the first ring to the second ring, and the sutures connecting the third ring to the second interior side are offset from the sutures connecting the third ring to the second ring.

19. The method of manufacture of claim 17 wherein the rings comprise a non-thrombogenic material.

20. The method of manufacture of claim 17 wherein the rings comprise biocompatable wire.

21. A method of manufacturing a self centering mechanism for an occlusion device, the method comprising:

forming a centering mechanism by attaching a first ring to a second ring and attaching the second ring to a third ring;

securing the first ring to a first interior side of the occlusion device;

securing the third ring to a second interior side of the occlusion device; and

wherein heat laminating is used to connect the first ring to the first interior side, the second ring to the first ring, the second ring to the third ring, and the third ring to the second interior side at laminated locations.

22. The method of manufacture of claim 21 wherein the laminated locations connecting the first ring to the first interior side are offset from the laminated locations connecting the second ring to the first ring, the laminated locations connecting the second ring to the third ring are offset from the laminated locations connecting the first ring to the second ring, and the laminated locations connecting the third ring to the second interior side are offset from the laminated locations connecting the third ring to the second ring.

23. A method of manufacturing a self centering mechanism for an occlusion device, the method comprising:

forming a centering mechanism by attaching a first ring to a second ring and attaching the second ring to a third ring;

securing the first ring to a first interior side of the occlusion device;

securing the third ring to a second interior side of the occlusion device; and

wherein the rings comprise polyvinyl alcohol foam.

24. An occlusion device comprising:

a center post;

first and second sets of arms connected to the center post, the first and second set of arms comprising at least five arms;

first and second sheets attached to the first and second sets of arms respectively; and

a self centering mechanism comprising a flexible honeycomb structure surrounding the center post and connected between the first and second set of arms.

25. The occlusion device of claim 24 wherein sutures are used to connect the first ring to a left side of the occlusion device, the second ring to the first ring, the second ring to the third ring and the third ring to a right side of the occlusion device at suture locations.

26. The occlusion device of claim 25 wherein the suture locations connecting the first ring to the first side are offset from the sutures connecting the second ring to the first ring, the sutures connecting the second ring to the third ring are offset from the sutures connecting the first ring to the second ring, and the sutures connecting the third ring to the second side are offset from the sutures connecting the third ring to the second ring.

27. The occlusion device of claim 24 wherein heat laminating is used to connect the first ring to a left side of the occlusion device, the second ring to the first ring, the second ring to the third ring and the third ring to a right side of the occlusion device at laminated locations.

28. The occlusion device of claim 27 wherein the laminated locations connecting the first ring to the left side are offset from the laminated locations connecting the second ring to the first ring, the laminated locations connecting the second ring to the third ring are offset from the laminated locations connecting the first ring to the second ring, and the laminated locations connecting the third ring to the right side are offset from the laminated locations connecting the third ring to the second ring.

29. The occlusion device of claim 24 wherein the rings comprise polyvinyl alcohol foam.

30. The occlusion device of claim 24 wherein the rings comprise a non-thrombogenic material.

31. The occlusion device of claim 24 wherein the rings comprise biocompatable wire.

32. An occlusion device comprising:

a left side having a first set of arms;

a right side having a second set of arms;

a center post connecting the left side to the right side and configured to extend through an aperture;

a self centering mechanism located between the left and right sides and surrounding the center post wherein the self centering mechanism laterally expands to fill the aperture radially around the center post; and

wherein the self centering mechanism comprises at least three rings located between the left and right sides wherein;

a first ring is connected to the left side;

a second ring is connected to the first ring;

a third ring is connected to the second ring and to the right side.

33. The occlusion device of claim 32 wherein sutures are used to connect the first ring to the left side, the second ring to the first ring, the second ring to the third ring, and the third ring to the right side at suture locations.

34. The occlusion device of claim 33 wherein the suture locations connecting the first ring to the left side are offset from the sutures connecting the second ring to the first ring, the sutures connecting the second ring to the third ring are offset from the sutures connecting the first ring to the second ring and the sutures connecting the third ring to the right side are offset from the sutures connecting the third ring to the second ring.

35. The occlusion device of claim 32 wherein heat laminating is used to connect the first ring to the left side, the second ring to the first ring, the second ring to the third ring, and the third ring to the right side at laminated locations.

36. The occlusion device of claim 35 wherein the laminated locations connecting the first ring to the left side are offset from the laminated locations connecting the second ring to the first ring, the laminated locations connecting the second ring to the third ring are offset from the laminated locations connecting the first ring to the second ring, and the laminated locations connecting the third ring to the right side are offset from the laminated locations connecting the third ring to the second ring.

37. The occlusion device of claim 32 wherein the rings comprise polyvinyl alcohol foam.

38. The occlusion device of claim 32 wherein the rings comprise a non-thrombogenic material.

39. The occlusion device of claim 32 wherein the rings comprise biocompatable wire.