Patent foramen ovale (PFO) closure clips

• US 9,241,695 B2
• Filed: 03/25/2003
• Issued: 01/26/2016
• Est. Priority Date: 03/25/2002
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Inventors: Peavey, Todd A., Forde, Sean T., Chanduszko, Andrzej J., Callaghan, David J.
• Primary Examiner(s): Rodjom, Katherine
• Assistant Examiner(s): BACHMAN, LINDSEY MICHELE
• Application Number:
  US10/396,253
• Publication Number:
  US 20030225421A1
• Time in Patent Office: 4,690 Days
• Field of Search: 606/151, 606/213, 606/215, 606/157, 606/158, 606216-221, 606/139, 606/142, 606/143, 623/23.72, 24/671, 24/673, 24/679
• US Class Current: 1/1
• 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 17/083 Clips, e.g. resilient
• 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

Abstract

The present invention provides a patent foramen ovale (PFO) closure clip. The clips of the present invention include two closure members joined by at least two spaced central connecting members. Each of the at least two spaced central connecting members is attached to each closure member at a location on the periphery of the closure member. The clips are designed such that the at least two central connecting members extend through the inclined PFO tunnel and the two closure members compress the overlapping layers of septal tissue, i.e. septum primum and septum secundum, together to close the PFO tunnel. The clips of the present invention take various forms depending, in part, upon the distribution of force required to close a given PFO. Thus, in some embodiments, the closure members include arcuate peaks. In other embodiments, the closure members include loops. In still other embodiments, the closure members include prongs.

Claims

1. A device for closing a septal defect with two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, the device having a delivery configuration and a deployed configuration, the device comprising:

an elongated element arranged in a closed loop in both the delivery and deployed configurations, the elongated element defining a first and a second opposed closure member and at least two connecting members, the elongated element being elongated and straightened in the delivery configuration,

the first and second opposed closure members disposed on opposite sides of the septum, each closure member having a periphery, wherein each of the first and second closure members includes two curved portions, the two curved portions of the first closure member being connected at a first peak at a vertical center of the first closure member, the two curved portions of the second closure member being connected at a second peak at a vertical center of the second closure member, wherein the first and second peak generally oppose one another on opposite sides of the septum in the deployed configuration, and the first closure member and the second closure member configured to apply a compressive force to the overlapping layers in the deployed configuration, and wherein the first and second opposed closure members are substantially parallel to each other in the deployed configuration,

the at least two connecting members attached to each of said closure members at a location on the periphery of said closure members, wherein the connecting members extend between the overlapping layers of septum primum and septum secundum, and

portions of the at least two connecting members and the two curved portions of each of the first and second opposed closure members disposed to provide a compressive force to the overlapping layers of septum primum and septum secundum, wherein, in the deployed configuration, the first and second closure members are substantially symmetric, the first closure member is directed generally in a first direction, and the second closure member is directed generally in a direction opposite to the first direction across a longitudinal axis transverse to the connecting members, and wherein, in the deployed configuration, the compressive force is applied to the overlapping layers at locations where portions of the elongated element overlap, and wherein in the deployed configuration, the compressive force is concentrated at the center of the septal defect along the vertical center of the first closure member and the vertical center of the second closure member.

2. The device of claim 1, wherein said first closure member is sized and shaped to apply a compressive force to the layers of septum primum and septum secundum in the right atrium and said second closure member is sized and shaped to apply a compressive force to the layers of septum primum and septum secundum in the left atrium.

3. The device of claim 1, wherein said device includes a material selected from the group consisting of metals, nonmetallic materials, bioabsorbable polymers, spring steel, shape memory materials, bioabsorbable shape memory polymers, and combinations thereof.

4. The device of claim 3, wherein said device is constituted at least in part of nitinol.

5. The device of claim 1, wherein each of said first and second peaks are arcuate peaks.

6. The device of claim 5, wherein said arcuate peaks are oriented such that said arcuate peak of said first closure member is directed generally in a first direction and said arcuate peak of said second closure member is directed generally in an opposite direction.

7. The device of claim 6, said first closure member further comprising a point adapted to facilitate removal or repositioning of the device.

8. The device of claim 6, wherein the arcuate peak of the first closure member extends through the vertical center of the first closure member and the arcuate peak of the second closure member extends through the vertical center of the second closure member.

9. The device of claim 1, wherein the passage between septum primum and septum secundum forms a longitudinal axis and wherein said first and second closure members are configured to prevent movement along said longitudinal axis when said device is deployed.

10. The device of claim 9, wherein said first closure member contains first vertical centering structures and said second closure member contains second vertical centering structures such that, when said device is deployed, said first vertical centering structures are located in the right atrium, said second vertical centering structures are located in the left atrium, and said first and second vertical centering structures are opposed across the overlapping layers of septum primum and septum secundum.

11. The device of claim 10, wherein said first and second vertical centering structures include loops.

12. The device of claim 1, wherein said device further includes at least one centering element connecting said first and second closure members.

13. The device of claim 12, wherein said at least one centering element includes a material selected from the group consisting of metals, plastics, elastic materials, and shape memory materials.

14. The device of claim 13, wherein said at least one centering element is constituted at least in part of nitinol.

15. The device of claim 1, wherein each of said first and second closure members includes two C-shaped ends connected by a looped joinder strand including at least one U-shaped loop.

16. The device of claim 15, wherein said looped joinder strand of said first closure member is directed generally in a first direction and said looped joinder strand of said second closure member is directed generally in an opposite direction.

17. The device of claim 16, wherein each looped joinder strand includes three U-shaped loops.

18. The device of claim 16, wherein said looped joinder strand of said second closure member applies a compressive force to septum primum in the left atrium and said looped joinder strand of said first closure member applies a compressive force to septum secundum in the right atrium.

19. The device of claim 1, wherein at least one of said connecting members includes a generally straight section adapted to be disposed between septum primum and septum secundum.

20. The device of claim 19, wherein said at least one connecting member includes a curved section at the end of said connecting member.

21. The device of claim 20, wherein said closure member and said connecting member are formed of a single wire.

22. The device of claim 1, wherein the delivery configuration is of a generally low profile and is adapted to be delivered through a catheter.

23. A system for closing a septal defect with two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, the system comprising:

an elongated element defining a first and a second closure member and at least two connecting members,

the at least two connecting members attached to each of said closure members at a location on the periphery of said closure members,

said system having a first configuration adapted to be delivered through a catheter, said first configuration being of a generally low profile, the elongated element being arranged in a closed loop and being elongated and straightened in the first configuration,

said system having a second configuration once delivered into the desired delivery site, the elongated element being arranged in a closed loop in the second configuration,

the first and second opposed closure members disposed on opposite sides of the septum, each closure member having a periphery, wherein each of the first and second closure members includes two curved portions, the two curved portions of the first closure member being connected at a first peak at a vertical center of the first closure member, the two curved portions of the second closure member being connected at a second peak at a vertical center of the second closure member, wherein the first and second peak generally oppose one another on opposite sides of the septum in the second configuration, and the first closure member and the second closure member configured to apply a compressive force to the overlapping layers in the second configuration, and wherein the first and second opposed closure members are substantially parallel to each other in the second configuration, and

wherein in said second configuration including said connecting members, the system is adapted to extend between the overlapping layers of septum primum and septum secundum such that portions of the at least two connecting members and the two curved portions of each of the first and second opposed closure members are disposed to provide a compressive force to the overlapping layers of septum primum and septum secundum, and wherein, in the second configuration, the compressive force is applied to the overlapping layers at locations where portions of the elongated element overlap, and wherein in the second configuration, the compressive force is concentrated at the center of the septal defect along the vertical center of the first closure member and the vertical center of the second closure member.

24. The system of claim 23, wherein said system further comprises a catheter through which said elongated element is adapted to be delivered when in said first configuration.

25. The system of claim 23, wherein, in said second configuration, said first closure member is sized and shaped to apply a compressive force to the layers of septum primum and septum secundum in the right atrium and said second closure member is sized and shaped to apply a compressive force to the layers of septum primum and septum secundum in the left atrium.

26. The system of claim 23, wherein said system includes a material selected from the group consisting of metals, nonmetallic materials, bioabsorbable polymers, spring steel, shape memory materials, bioabsorbable shape memory polymers, and combinations thereof.

27. The system of claim 26, wherein said system is constituted at least in part of nitinol.

28. The system of claim 23, wherein each of said first and second peaks are arcuate peaks.

29. The system of claim 28, wherein, in said second configuration, the arcuate peaks are oriented such that said arcuate peak of said first closure member is directed generally in a first direction and said arcuate peak of said second closure member is directed generally in an opposite direction.

30. The system of claim 28, wherein said first closure member further comprises a point adapted to facilitate removal or repositioning of the system.

31. The system of claim 23, wherein the passage between septum primum and septum secundum forms a longitudinal axis and, in said second configuration, said first and second closure members are configured to prevent movement along said longitudinal axis.

32. The system of claim 31, wherein, in said second configuration, said first closure member contains first vertical centering structures and said second closure member contains second vertical centering structures, such that when said system is deployed, said first vertical centering structures are located in the right atrium, said second vertical centering structures are located in the left atrium, and said first and second vertical centering structures are opposed across the overlapping layers of septum primum and septum secundum.

33. The system of claim 32, wherein, in said second configuration, said first and second vertical centering structures include loops.

34. The system of claim 23, wherein said system further includes at least one centering element connecting said first and second closure members.

35. The system of claim 34, wherein said at least one centering element includes a material selected from the group consisting of metals, plastics, elastic materials, and shape memory materials.

36. The system of claim 35, wherein said at least one centering element is constituted at least in part of nitinol.

37. The system of claim 23, wherein, in said second configuration, each of said first and second closure members of said system includes two C-shaped ends connected by a looped joinder strand including at least one U-shaped loop.

38. The system of claim 37, wherein, in said second configuration, said looped joinder strand of said first closure member is directed generally in a first direction and said looped joinder strand of said second closure member is directed generally in an opposite direction.

39. The system of claim 38, wherein, in said second configuration, said looped joinder strand includes three U-shaped loops.

40. The system of claim 38, wherein said looped joinder strand of said second closure member applies a compressive force to septum primum in the left atrium and said looped joinder strand of said first closure member applies a compressive force to septum secundum in the right atrium.

41. The system of claim 23, wherein, in the deployed configuration, the first and second closure members are substantially symmetric, the first closure member is directed generally in a first direction, and the second closure member is directed generally in a direction opposite to the first direction across a longitudinal axis transverse to the connecting members.

42. The system of claim 23, wherein said elongated element is formed of a single wire.

43. A system for closing a septal defect with two overlapping layers of tissue, the system having a delivery configuration and a deployed configuration, the system comprising:

an elongated element arranged in a closed loop in both the delivery and deployed configurations, the elongated element defining a first and a second closure members and at least two connecting members, the elongated element being elongated and straightened in the delivery configuration,

the first and second opposed closure members disposed on opposite sides of the tissue, each closure member having a periphery, wherein each of the first and second closure members includes two curved portions, two elongate side strands, and a peak at a vertical center of the first and second closure members, the peak joining the two elongate side strands, and each peak having a peak angle of about 90 degrees or less, the first closure member and the second closure member configured to apply a compressive force to the overlapping layers in the deployed configuration, and wherein the first and second opposed closure members are substantially parallel to each other in the deployed configuration, the at least two connecting members attached to each of said closure members at a location on the periphery of said closure members, said connecting members attached to said closure members at an acute angle such that said closure members and said connecting members form a relatively flat device in the deployed configuration, wherein the connecting members extend between the overlapping layers of tissue, and

portions of the at least two connecting members and the two curved portions of each of the first and second opposed closure members disposed to provide a compressive force to the overlapping layers, and wherein, in the deployed configuration, the compressive force is applied to the overlapping layers at locations where portions of the elongated element overlap, and wherein in the deployed configuration, the compressive force is concentrated at the center of the septal defect along the vertical center of the first and second closure members.

44. The system of claim 43, wherein said system further comprises a catheter through which said device is adapted to be delivered in an elongated form.

45. The system of claim 43, wherein said device includes a material selected from the group consisting of metals, nonmetallic materials, bioabsorbable polymers, spring steel, shape memory materials, bioabsorbable shape memory polymers, and combinations thereof.

46. The system of claim 45, wherein said device is constituted at least in part of nitinol.

47. The system of claim 43, wherein each of said peaks of said first and second closure members of said device are arcuate peaks.

48. The system of claim 43, wherein said peaks are oriented such that said peak of said first closure member is directed generally in a first direction and said peak of said second closure member is directed generally in an opposite direction.

49. The system of claim 48, wherein said side strands joined to each peak are oriented from the peak to which the side strands are joined such that, when implanted, said side strands of each peak contact the tissue and apply a compressive force against the tissue.

50. The system of claim 48, wherein a defect defined by the two overlapping layers of tissue has a longitudinal axis and wherein each peak and said side strands joined to each corresponding peak are configured to extend transverse to the general direction of said longitudinal axis.

51. The system of claim 50, wherein said first closure member further comprises a point adapted to facilitate removal or repositioning of the device.

52. The system of claim 43, wherein the delivery configuration is of a generally low profile and is adapted to be delivered through a catheter.