Left atrial appendage closure device

• US 7,566,336 B2
• Filed: 11/25/2003
• Issued: 07/28/2009
• Est. Priority Date: 11/25/2003
• Status: Active Grant

• Current Assignee: Atrial Solutions Incorporated
• Original Assignee: Cardia, Inc.
• Inventors: Marino, Joseph A., Corcoran, Michael P.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/721,723
• Publication Number:
  US 20050113861A1
• Time in Patent Office: 2,072 Days
• Field of Search: 606/151, 606/157, 606/158, 606/113, 606/127, 606/213, 606/214, 606/153
• US Class Current: 606/151
• 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 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12095 Threaded connection

Abstract

This invention relates to an occlusion device for the closure of a physical lumen. More specifically, this invention relates to an occlusion device for the left atrial appendage of the heart, comprising a center post, a plurality of ribs extending along the center post and sheet which is attached to the ribs.

Claims

1. An occlusion device for occluding a left atrial appendage, the occlusion device comprising:

a center post having a proximal end and a distal end;

a plurality of ribs extending radially outward from the proximal end of the center post to the distal end of the center post to form a frame, wherein a diameter of the frame near the proximal end of the center post is greater than a diameter of the frame near the distal end of the center post and is shaped to securely fit within a left atrial appendage; and

a PVA foam sheet attached to the ribs, the sheet extending between the ribs and forming a sack shaped barrier supported by the ribs that is closed at the proximal end and extends toward the distal end a distance sufficient to close an entrance to the left atrial appendage and to prevent blood from entering or exiting the left atrial appendage.

2. The occlusion device of claim 1 wherein the center post is formed of titanium.

3. The occlusion device of claim 1 wherein the center post comprises two segments.

4. The center post of claim 3 wherein a first segment of the center post comprises a pin and a second segment of the center post comprises a lumen and wherein the pin of the first segment connects with the lumen of the second segment.

5. The occlusion device of claim 1 wherein the center post further comprises holes through which the ribs attach.

6. The occlusion device of claim 1 wherein the center post is about 5 to about 40 mm long.

7. The occlusion device of claim 1 wherein the ribs are constructed of stranded wire.

8. The occlusion device of claim 7 wherein the stranded wire is heat shaped.

9. The occlusion device of claim 1 wherein the ribs are constructed of a single stranded wire.

10. The occlusion device of claim 9 wherein the stranded wire is heat shaped.

11. The occlusion device of claim 1 wherein the sheet is attached to the ribs with sutures.

12. The occlusion device of claim 1 wherein the sheet is laminated to the ribs.

13. The occlusion device of claim 1 wherein the sheet is treated to be non-thrombogenic.

14. A collapsible occlusion device for insertion into a left atrial appendage of a human heart, the device comprising:

a center post having a proximal end and a distal end, wherein both the proximal end and the distal end comprise a plurality of holes;

a single stranded wire threaded through holes in the distal and proximal ends of the center post to form a plurality of ribs, wherein the plurality of ribs define a frame having a diameter near the proximal end of the center post that is larger than a diameter near the distal end of the center post and is shaped to securely fit within a left atrial appendage; and

a foam sheet attached to the plurality of ribs, the sheet extending between the ribs and forming a sack shaped barrier supported by the ribs that is closed at the proximal end and extends toward the distal end a distance sufficient to close an entrance to the left atrial appendage and to prevent blood from entering or exiting the left atrial appendage.

15. The occlusion device of claim 14 wherein the center post comprises a grasping knob.

16. The occlusion device of claim 14 wherein the center post is formed of titanium.

17. The occlusion device of claim 14 wherein the center post comprises two segments.

18. The center post of claim 17 wherein a first segment of the centerpost comprises a pin and a second segment of the center post comprises a lumen and wherein the pin of the first segment connects with the lumen of the second segment.

19. The occlusion device of claim 14 wherein the center post is about 5 to about 40 mm long.

20. The occlusion device of claim 14 wherein the ribs are heat shaped.

21. The occlusion device of claim 14 wherein the sheet is constructed of PVA foam.

22. The occlusion device of claim 14 wherein the sheet is attached to the ribs with sutures.

23. The occlusion device of claim 14 wherein the sheet is laminated to the ribs.

24. The occlusion device of claim 14 wherein the sheet is treated to be non-thrombogenic.

25. A left atrial appendage occlusion device comprising:

a center post comprising a proximal end, a distal end, and a graspable component;

a plurality of holes located in the proximal end of the center post;

a plurality of holes located in the distal end of the center post;

a single wire extending from the proximal end of the center post to the distal end of the center post and passing through holes in the distal end of the center post and proximal end of the center post to form a plurality of ribs, wherein the plurality of ribs define a frame having a diameter near the proximal end of the center post that is larger than a diameter near the distal end of the center post and is shaped to securely fit within a left atrial appendage; and

a foam sheet attached to the plurality of ribs, the sheet extending between the ribs and forming a sack shaped barrier supported by the ribs that is closed at the proximal end and extends toward the distal end a distance sufficient to close an entrance to the left atrial appendage and to prevent blood from entering or exiting the left atrial appendage.

26. The occlusion device of claim 25 wherein the center post is formed of titanium.

27. The occlusion device of claim 25 wherein the center post comprises two segments.

28. The center post of claim 27 wherein a first segment of the center post comprises a pin and a second segment of the center post comprises a lumen and wherein the pin of the first segment connects with the lumen of the second segment.

29. The occlusion device of claim 25 wherein the length of the center post is about 5 to about 40 mm long.

30. The occlusion device of claim 25 wherein the ribs are constructed of stranded wire.

31. The occlusion device of claim 25 wherein the ribs are heat shaped.

32. The occlusion device of claim 25 wherein the foam sheet is constructed of PVA foam.

33. The occlusion device of claim 25 wherein the foam sheet is attached to the ribs by sutures.

34. The occlusion device of claim 25 wherein the foam sheet is attached to the ribs by heat laminating.

35. The occlusion device of claim 25 wherein the foam sheet is treated to be non-thrombogenic.

36. An occlusion device for occluding a left atrial appendage, the occlusion device comprising:

a center post having a proximal end and a distal end;

a plurality of ribs extending radially outward from the proximal end of the center post to the distal end of the center post to create a generally pear shaped frame, wherein a diameter of the frame near the proximal end of the center post is greater than a diameter of the frame near the distal end of the center post and is shaped to securely fit within a left atrial appendage; and

a sheet formed of a medical grade polymer attached to the ribs, the sheet extending between the ribs and forming a sack shaped barrier supported by the ribs that is closed at the proximal end and extends toward the distal end a distance sufficient to close an entrance to the left atrial appendage and to prevent blood from entering or exiting the left atrial appendage.

37. The occlusion device of claim 36 wherein the center post is formed of titanium.

38. The occlusion device of claim 36 wherein the center post comprises two segments.

39. The center post of claim 36 wherein a first segment of the center post comprises a pin and a second segment of the center post comprises a lumen and wherein the pin of the first segment connects with the lumen of the second segment.

40. The occlusion device of claim 36 wherein the center post further comprises holes through which the ribs attach.

41. The occlusion device of claim 36 wherein the center post is about 5 to about 40 mm long.

42. The occlusion device of claim 36 wherein the ribs are constructed of a single stranded wire.

43. The occlusion device of claim 36 wherein the ribs are heat shaped.

44. The occlusion device of claim 36 wherein the sheet is constructed of PVA foam.

45. The occlusion device of claim 36 wherein the sheet is attached to the ribs with sutures.

46. The occlusion device of claim 36 wherein the sheet is laminated to the ribs.

47. The occlusion device of claim 36 wherein the sheet is treated to be non-thrombogenic.