Heart occlusion devices
View Patent ↗The disclosure is directed to a heart occlusion device and a method for occluding an aperture defect in a heart. The heart occlusion device includes two separate wires 12, 14 . Each wire forms geometric shapes that together form a distal plate and a proximal plate. The first plate is disposed in a first plane. The second plate is disposed in a second plane that is parallel to and remote from the first plane. The distal plate and the proximal plate are separated by a self-centering waist. The proximal plate is attached to a hub. A similar hub is optional on the distal plate. The plates further include coverings which form a sealant to occlude an aperture in a tissue. The wires forming the plates have a shape-memory capability such that they can be collapsed and distorted in a catheter during delivery but resume and maintain their intended shape after delivery.
1. A device for occluding an aperture in tissue, the device comprising:
a first flexible wire;
a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires has a first and a second end; and
a hub, wherein each of the first and second ends of the first and second wires are connected to the hub,
wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is remote from the first plane, and
wherein the first and second plates are separated by a waist, the waist comprising a first waist portion and a second waist portion, the first waist portion having a first length, and the second waist portion having a second length that is greater than the first length.
2. The device of claim 1 , wherein the first geometric forms of the first and second wires are generally semi-circular.
3. The device of claim 1 , wherein:
the first plate comprises a first disc; and
the second plate comprises a second disc.
4. The device of claim 1 , further comprising:
a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.
5. The device of claim 1 , wherein the waist is self-centering.
6. The device of claim 1 , wherein:
the first waist portion has a first waist surface area; and
the second waist portion has a second waist surface area that is greater than the first waist surface area.
7. A device for occluding an aperture in tissue, the device comprising:
a first flexible wire;
a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires has a first and a second end; and
a hub, wherein each of the first and second ends of the first and second wires are connected to the hub,
wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is remote from the first plane, and wherein the first and second plates are separated by a waist comprising:
a first segment of the first wire, the first segment of the first wire having a first length;
a second segment of the first second wire, a length of the second segment of the first wire being substantially equal to the first length;
a first segment of the second wire, the first segment of the second wire having a second length that is greater than the first length; and
a second segment of the second wire, a length of the second segment of the second wire being substantially equal to the second length.
8. The device of claim 7 , wherein at least one of the first segment of the first wire, the second segment of the first wire, the first segment of the second wire, and the second segment of the second wire comprises an arc segment.
9. The device of claim 7 , wherein each of the first segment of the first wire, the second segment of the first wire, the first segment of the second wire, and the second segment of the second wire comprises an arc segment.
10. The device of claim 7 , wherein the first geometric forms of the first and second wires are generally semi-circular.
11. The device of claim 7 , wherein:
the first plate comprises a first disc; and
the second plate comprises a second disc.
12. The device of claim 7 , further comprising:
a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.
13. The device of claim 7 , wherein the waist is self-centering.
14. A device for occluding an aperture in tissue, the device comprising:
a first flexible wire;
a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires has a first and a second end; and
a hub, wherein each of the first and second ends of the first and second wires are connected to the hub,
wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is remote from the first plane, and
wherein the first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire, the first plate and the second plate forming a non-zero angle with respect to one another.
15. The device of claim 14 , wherein the non-zero angle is greater than five degrees.
16. The device of claim 14 , wherein the non-zero angle is greater than ten degrees.
17. The device of claim 14 , wherein the non-zero angle is approximately equal to twenty degrees.
18. The device of claim 14 , wherein the first geometric forms of the first and second wires are generally semi-circular.
19. The device of claim 14 , wherein:
the first plate comprises a first disc; and
the second plate comprises a second disc.
20. The device of claim 14 , further comprising:
a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.
21. The device of claim 14 , wherein the waist is self-centering.
22. A device for occluding an aperture in tissue, the device comprising:
a first flexible wire;
a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires has a first and a second end; and
a hub, wherein each of the first and second ends of the first and second wires are connected to the hub,
wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is remote from the first plane, and
wherein the first and second plates are not substantially parallel to one another and are separated by a waist formed from two portions of the first wire and two portions of the second wire.
23. The device of claim 22 , wherein the first geometric forms of the first and second wires are generally semi-circular.
24. The device of claim 22 , wherein:
the first plate comprises a first disc; and
the second plate comprises a second disc.
25. The device of claim 22 , further comprising:
a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.
26. The device of claim 22 , wherein the waist is self-centering.
27. A device for occluding an aperture in tissue, the device comprising:
a first flexible wire; and
a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires has a first and a second end; and
a hub, wherein each of the first and second ends of the first and second wires are connected to the hub,
wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is remote from the first plane, and
wherein the first and second plates are separated by a waist formed from a first waist component of the first wire and a second waist component of the second wire, the first and second waist components being of unequal sizes.
28. The device of claim 27 , wherein:
the first waist component has a first length;
the second waist component has a second length; and
the second length is larger than the first length.
29. The device of claim 27 , wherein:
the first waist component has a first surface area;
the second waist component has a second surface area; and
the second surface area is larger than the first surface area.
30. The device of claim 27 , wherein:
the first waist component has a first radius;
the second waist component has a second radius; and
the second radius is larger than the first radius.
31. The device of claim 27 , wherein the first geometric forms of the first and second wires are generally semi-circular.
32. The device of claim 27 , wherein:
the first plate comprises a first disc; and
the second plate comprises a second disc.
33. The device of claim 27 , further comprising:
a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.
34. The device of claim 27 , wherein the waist is self-centering.
35. A device for occluding an aperture in tissue, the device comprising:
a first flexible wire; and
a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires has a first and a second end; and
a hub, wherein each of the first and second ends of the first and second wires are connected to the hub,
wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is remote from the first plane, and
wherein the first and second plates are separated by a waist formed from a first waist component of the first wire and a second waist component of the second wire, the first and second waist components configured to generate a non-zero angle of curvature for the waist.
36. The device of claim 35 , wherein the angle of curvature is not equal to zero.
37. The device of claim 35 , wherein the angle of curvature is greater than five degrees.
38. The device of claim 35 , wherein the angle of curvature is greater than ten degrees.
39. The device of claim 35 , wherein the angle of curvature is approximately equal to twenty degrees.
40. The device of claim 35 , wherein the first geometric forms of the first and second wires are generally semi-circular.
41. The device of claim 35 , wherein:
the first plate comprises a first disc; and
the second plate comprises a second disc.
42. The device of claim 35 , further comprising:
a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.
43. The device of claim 35 , wherein the waist is self-centering.