Heart valve sealing devices and delivery devices therefor
An implantable prosthetic device includes a coaption portion, paddles, and clasps. The paddles are extendable from a folded closed position to an open position. A clasp is attached to each of the paddles. The clasps have a fixed arm attached to the paddle and a moveable arm. The moveable arm has a barbed portion, a first eyelet, and a second eyelet. The hinge portion connects the fixed arm to the moveable arm. A first intermediate suture loop is attached to the first eyelet and a second intermediate suture loop is attached to the second eyelet. At least one actuation suture is attached to the first and second intermediate suture loops.
1. An implantable prosthetic device comprising:
a coaption portion;
an anchor portion comprising a plurality of paddles, the paddles having an outer and inner portion and being extendable from a folded closed position to an open position;
a clasp attached to each of the plurality of paddles, the clasp comprising:
a fixed arm attached to the inner portion of the paddle;
a moveable arm having a barbed portion, a first eyelet, and a second eyelet; and
a hinge portion hingeably connecting the fixed arm to the moveable arm;
a first intermediate suture loop attached to the first eyelet;
a second intermediate suture loop attached to the second eyelet; and
at least one actuation suture attached to the first and second intermediate suture loops.
2. The implantable prosthetic device according to claim 1 , wherein the first eyelet is arranged proximate a first side of the clasp and the second eyelet is arranged proximate a second side of the clasp.
3. The implantable prosthetic device according to claim 1 , further comprising a first side gap between a first side of the clasp and the first eyelet and a second side gap between the second side of the clasp and the second eyelet; wherein the first and second side gaps are less than one third a width of the clasp.
4. The implantable prosthetic device according to claim 1 , wherein the first and second intermediate suture loops wrap around an end of the moveable arm.
5. The implantable prosthetic device according to claim 1 , wherein the first and second intermediate suture loops extend through an opening in the moveable arm.
6. The implantable prosthetic device according to claim 1 , wherein an end of the moveable arm is rounded.
7. The implantable prosthetic device according to claim 1 , wherein the hinge portion comprises a plurality of spring segments, wherein each spring segment is connected to a plurality of spring segments.
8. The implantable prosthetic device according to claim 7 , wherein the spring segments are torsional spring segments.
9. The implantable prosthetic device according to claim 7 , wherein:
the spring segments comprise a first end and a second end; and
the first end of one spring segment is connected to at least one of the first and second end of another spring segment.
10. The implantable prosthetic device according to claim 9 , wherein:
the spring segments are arranged into a plurality of rows and columns;
the first or second ends of spring segments proximate a side edge of the clasp are joined to one other spring segment; and
the first or second ends of spring segments proximate an adjacent column are joined to at least one other spring segment.
11. The implantable prosthetic device according to claim 7 , wherein:
the spring segments comprise a first end, a second end, a first side, and a second side;
a first side joining location is adjacent the first end;
a first end joining location is adjacent the first side;
a second side joining location is adjacent the second end; and
a second end joining location is adjacent the second side.
12. The implantable prosthetic device according to claim 7 , wherein:
the spring segments are arranged in a pattern having three columns and seven rows of spring segments.
13. The implantable prosthetic device according to claim 1 , wherein the clasp is formed from a top layer and a bottom layer, the top and bottom layers formed of shape memory material.
14. The implantable prosthetic device according to claim 13 , wherein the top and bottom layers are only joined in one location to allow the top and bottom layers to slide relative to one another during opening of the clasp.
15. The implantable prosthetic device according to claim 13 , wherein barbs are formed in at least two of the plurality of layers.
16. The implantable prosthetic device according to claim 1 , wherein the clasp is formed from shape memory material and the fixed and moveable arms are shape set in a preloading position so that a pinch force exists between the fixed and moveable arms when the fixed arm is approximately parallel with the moveable arm.
17. The implantable prosthetic device according to claim 16 , wherein the fixed arm is bent in the closing direction beyond the closed position to the preloading position.
18. The implantable prosthetic device according to claim 17 , wherein the fixed arm is bent in the closing direction to about 45 degrees beyond the closed position to the preloading position.
19. The implantable prosthetic device according to claim 17 , wherein the fixed arm is bent in the closing direction to about 90 degrees beyond the closed position to the preloading position.
20. The implantable prosthetic device according to claim 17 , wherein after shape setting, the fixed arm is prohibited from returning to the preloading position by a cross-member.
21. The implantable prosthetic device according to claim 20 , wherein the cross-member is an integral cross-member.
22. The implantable prosthetic device according to claim 1 , wherein a plastic limit of the material of the clasp is not exceeded when the moveable arm is opened to a fully open position about 140 degrees from the fixed arm.
23. The implantable prosthetic device according to claim 1 , wherein the clasp is formed from a shape memory material having a thick portion and a thin portion.
24. The implantable prosthetic device according to claim 1 , wherein barbs of the barbed portion are tapered in the direction of the length of the clasp.
25. The implantable prosthetic device according to claim 1 , wherein the barbs of the barbed portion end in a point.
26. A clasp comprising:
a fixed arm;
a moveable arm having a barbed portion, a first eyelet, and a second eyelet; and
a hinge portion hingeably connecting the fixed arm to the moveable arm;
a first intermediate suture loop attached to the first eyelet;
a second intermediate suture loop attached to the second eyelet; and
at least one actuation suture attached to the first and second intermediate suture loops.
27. The clasp according to claim 26 , wherein the first eyelet is arranged proximate a first side of the clasp and the second eyelet is arranged proximate a second side of the clasp.
28. The clasp according to claim 26 , further comprising a first side gap between a first side of the clasp and the first eyelet and a second side gap between the second side of the clasp and the second eyelet; wherein the first and second side gaps are less than one third a width of the clasp.
29. The implantable prosthetic device according to claim 28 , wherein the first and second side gaps are less than one quarter a width of the clasp.
30. The clasp according to claim 26 , wherein the first and second intermediate suture loops wrap around an end of the moveable arm.
31. The clasp according to claim 26 , wherein the first and second intermediate suture loops extend through an opening in the moveable arm.
32. The clasp according to claim 26 , wherein an end of the moveable arm is rounded.
33. The clasp according to claim 26 , wherein the hinge portion comprises a plurality of spring segments, wherein each spring segment is connected to a plurality of spring segments.
34. The clasp according to claim 33 , wherein the spring segments are torsional spring segments.
35. The clasp according to claim 33 , wherein:
the spring segments comprise a first end and a second end; and
the first end of one spring segment is connected to at least one of the first and second end of another spring segment.
36. The clasp according to claim 35 , wherein:
the spring segments are arranged into a plurality of rows and columns;
the first or second ends of spring segments proximate a side edge of the clasp are joined to one other spring segment; and
the first or second ends of spring segments proximate an adjacent column are joined to at least one other spring segment.
37. The clasp according to claim 33 , wherein:
the spring segments comprise a first end, a second end, a first side, and a second side;
a first side joining location is adjacent the first end;
a first end joining location is adjacent the first side;
a second side joining location is adjacent the second end; and
a second end joining location is adjacent the second side.
38. The clasp according to claim 33 , wherein:
the spring segments are arranged in a pattern having three columns and seven rows of spring segments.
39. The clasp according to claim 26 , wherein the clasp is formed from a top layer and a bottom layer, the top and bottom layers formed of shape memory material.
40. The clasp according to claim 39 , wherein the top and bottom layers are only joined in one location to allow the top and bottom layers to slide relative to one another during opening of the clasp.
41. The clasp according to claim 39 , wherein barbs are formed in at least two of the plurality of layers.
42. The clasp according to claim 26 , wherein the clasp is formed from shape memory material and the fixed and moveable arms are shape set in a preloading position so that a pinch force exists between the fixed and moveable arms when the fixed arm is approximately parallel with the moveable arm.
43. The clasp according to claim 42 , wherein the fixed arm is bent in the closing direction beyond the closed position to the preloading position.
44. The clasp according to claim 43 , wherein the fixed arm is bent in the closing direction to about 45 degrees beyond the closed position to the preloading position.
45. The clasp according to claim 43 , wherein the fixed arm is bent in the closing direction to about 90 degrees beyond the closed position to the preloading position.
46. The clasp according to claim 43 , wherein after shape setting, the fixed arm is prohibited from returning to the preloading position by a cross-member.
47. The clasp according to claim 46 , wherein the cross-member is an integral crossmember.
48. The clasp according to claim 26 , wherein a plastic limit of the material of the clasp is not exceeded when the moveable arm is opened to a fully open position about 140 degrees from the fixed arm.
49. The clasp according to claim 26 , wherein the clasp is formed from a shape memory material having a thick portion and a thin portion.
50. The clasp according to claim 26 , wherein barbs of the barbed portion are tapered in the direction of the length of the clasp.
51. The clasp according to claim 26 , wherein the barbs of the barbed portion end in a point.