Heart-shaped PFO closure device

• US 20050267525A1
• Filed: 04/21/2005
• Published: 12/01/2005
• Est. Priority Date: 04/26/2004
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: NMT Medical Incorporated
• Inventors: Chanduszko, Andrzej J.
• Granted Patent: US 8,361,110 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 17/083 Clips, e.g. resilient
• 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 2017/00606 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

Patent foramen ovale (PFO) closure clip include two closure members, which may be heart shaped, 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 connecting member may be generally square shaped or include other shapes. 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 may be formed of various materials, including metals, nonmetallic materials, bioresorbable polymers, spring steel, shape memory materials, bioresorbable shape memory polymers, or combinations thereof. The clips can take various forms depending, in part, upon the distribution of force required to close a given PFO. At least one of the closure members can include a tissue scaffold.

Claims

1. A device for closing two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, comprising first and second opposed closure members disposed on opposite sides of the septum, each closure member having a periphery, and at least two connecting members attached to each of said closure members at a location on the periphery of said closure members, wherein said connecting members extend between the overlapping layers of septum primum and septum secundum such that said first and second closure members cooperate to provide a compressive force to the overlapping layers of septum primum and septum secundum and wherein the closure members have a generally heart shape.

2. The device of claim 1, wherein said generally heart shaped 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 generally heart shaped 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, bioresorbable polymers, spring steel, shape memory materials, bioresorbable 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 at least one of said first and second closure members includes an arcuate peak joining two elongate side strands with varying separation along the length of the elongate side strands.

6. The device of claim 5, wherein said first and second closure members of said device both include arcuate peaks, and 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, wherein said side strands are oriented from said arcuate peak such that when implanted, said side strands contact the septum and apply a compressive force against the septum that.

8. The device of claim 6, wherein said closure members have a longitudinal axis and wherein the connecting member is a generally square shape.

9. The device of claim 8, wherein said first closure member further comprising a point adapted to facilitate removal or repositioning of the device.

10. The device of claim 8, wherein said peak and said side strands of at least one of said first and second closure members extend through the vertical center of said at least one closure member, and said peak points downward when the device is deployed in vivo.

11. The device of claim 10, 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.

12. The device of claim 1, further comprising a catheter, wherein said catheter contains said device in an elongated form.

13. A device for closing two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, comprising at least one closure member disposed on one side of the septum, said at least one closure member having a periphery, and a generally rectangular connecting member attached to said periphery of said closure member, wherein said connecting member extends between the overlapping layers of septum primum and septum secundum such that said closure member cooperates with the connecting member to provide a compressive force to the overlapping layers of septum primum and septum secundum.

14. The device of claim 13, further comprising at least two closure members attached to said periphery of said connecting member.

15. The device of claim 14, wherein said connecting member includes a generally straight section adapted to be disposed between septum primum and septum secundum.

16. The device of claim 14, wherein said connecting member includes a curved section at the end of said connecting member not attached to said closure member.

17. The device of claim 13, wherein said closure member has a configuration designed to distribute forces along the septum.

18. The device of claim 13, wherein the at least one closure member is generally heart shaped.

19. The device of claim 13, wherein the at least one closure member is generally rounded.

20. The device of claim 13, wherein the at least on closure member is generally rectangular shaped.

21. The device of claim 13, further comprising a second closure member adapted to be disposed on the other side of the septum when the device is implanted in vivo, wherein the second closure member is generally heart shaped.

22. A system for closing two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, comprising first and second opposed generally heart shaped closure members disposed on opposite sides of the septum, each closure member having a periphery, and 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,

said system having a second configuration once delivered into the desired delivery site, said second configuration including said connecting members adapted to extend between the overlapping layers of septum primum and septum secundum such that said first and second closure members cooperate to provide a compressive force to the overlapping layers of septum primum and septum secundum.

23. The system of claim 22, wherein said system further comprises a catheter through which said closure device is adapted to be delivered when in said first configuration.

24. The system of claim 22, wherein, in said second configuration, said first generally heart shaped 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 generally heart shaped closure member is sized and shaped to apply a compressive force to the layers of septum primum and septum secundum in the left atrium.

25. The system of claim 23, 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.

26. The system of claim 25, wherein said device is constituted at least in part of nitinol.

27. The system of claim 26, wherein, in said second configuration, at least one of said first and second closure members of said device includes an arcuate peak joining two elongate side strands.

28. The system of claim 26, wherein, in said second configuration, said first and second closure members of said device both include arcuate peaks, and 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 peaks of said second closure member is directed generally in an opposite direction.

29. The system of claim 23, wherein, in said second configuration, said side strands are oriented from said arcuate peak such that said side strands contact the septum and apply a compressive force against the septum.

30. The system of claim 23, wherein the connecting member is generally square shaped.

31. The system of claim 23, wherein the connecting member is formed of at least two strands which are separated along at least some distance with the device is in vivo so that the device is deployed in a central location in the desire location.

32. The system of claim 23 wherein the connecting member includes a curved portion and a generally rectangular portion.