Replacement heart valve, valve holder and methods of making and using same

• US 20080262608A1
• Filed: 04/21/2008
• Published: 10/23/2008
• Est. Priority Date: 04/23/2007
• Status: Active Grant

• Current Assignee: Cormatrix Cardiovascular, Inc.
• Original Assignee: Saint Joseph's Translational Research Institute Incorporated
• Inventors: MATHISON, Megumi
• Granted Patent: US 7,998,196 B2
• Time in Patent Office: Days
• US Class Current: 623/2.1
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: Y10T 29/49405 Valve or choke making

Abstract

A replacement heart valve device usable in a medical procedure in relation in heart valve replacement of a patient. In one embodiment, the replacement heart valve device includes a heart valve holder or conduit holder formed in the form of a cylindrical tube having a longitudinal cut substantially extending from one end to the other end of the cylindrical tube, and a conduit formed with a tubular segment of an elastic material. The conduit is mountable onto the heart valve holder or conduit holder or self-expanding stent. In one embodiment, at least a portion of the conduit is formed with a single layer of the elastic material. In another embodiment, at least a portion of the conduit is formed with two layers of the elastic material.

Claims

1. A method of making a replacement heart valve that is implantable to a patient, comprising the steps of:

a. providing a tubular segment of an elastic material having a first end portion and an opposite, second end portion, an interior surface, an exterior surface and a diameter d₁;

b. folding the first end portion inside-out towards to the second end portion such that the first end of the tubular segment reaches a position on the exterior surface and the tubular segment has a new first end, wherein the first end and the new first end define a new first end portion with an axial distance d₂ that is substantially equals to d₁;

c. forming a plurality of cusps on the new first end portion axially; and

d. inverting the tubular segment inside-out so that the exterior surface of the tubular segment and the interior surface of the tubular segment exchange their geometric positions to form a replacement heart valve that has a conduit at least partially with a single layer of intestinal tissue.

2. The method of claim 1, wherein the elastic material is one of an intestinal tissue obtained from a mammalian abdomen, a man-made bio-compatible tissue, and a polymeric material.

3. The method of claim 2, wherein the intestinal tissue is extracted from the patient who receives the replacement heart valve.

4. The method of claim 1, wherein the step of forming a plurality of cusps on the new first end portion axially comprises the step of forming three cusps by sewing along three lines on the new first end portion longitudinally.

5. The method of claim 4, wherein the three cusps are formed substantially parallel to each other and substantially apart from each other in about 120°

, as seen from a longitudinal, central axis of the tubular segment.

6. The method of claim 4, wherein the sewing is performed with 7-0 or 6-0 prolene.

7. The method of claim 1, wherein in operation, the conduit at least partially with a single layer of intestinal tissue is mounted onto a conduit holder.

8. The method of claim 1, further comprising the step of folding the second end portion inside-out towards to the new first end such that the second end of the tubular segment substantially reaches the new first end and a replacement heart valve that has a conduit at least partially with two layers of intestinal tissue is formed with the new first end and a new second end, wherein the new first end and the new second end define an axial distance d₃ that is no smaller than either of d₁ and d₂.

9. The method of claim 8, wherein in operation, the conduit at least partially with two layers of intestinal tissue is mounted onto a conduit holder.

10. A replacement heart valve implantable in a patient, comprising:

a. a conduit formed with a tubular segment of an elastic material, wherein the conduit has a first end portion and an opposite, second end portion; and

b. a plurality of cusps formed axially extending inwardly from one of the first and second end portions.

11. The replacement heart valve of claim 10, wherein the elastic material is one of an intestinal tissue obtained from a mammalian abdomen, a man-made bio-compatible tissue, and a polymeric material.

12. The replacement heart valve of claim 11, wherein the intestinal tissue is extracted from a patient who receives the replacement heart valve.

13. The replacement heart valve of claim 10, wherein the plurality of cusps comprises three cusps.

14. The replacement heart valve of claim 13, wherein the three cusps are formed substantially apart from each other in 120°

, as seen from a longitudinal, central axis of the conduit.

15. The replacement heart valve of claim 10, wherein at least a portion of the conduit is formed with a layer of intestinal tissue.

16. The replacement heart valve of claim 10, wherein at least a portion of the conduit is formed with two layers of intestinal tissue.

17. A method of making a heart valve holder or conduit holder usable for mounting a conduit formed with an elastic material, comprising the steps of:

a. providing a tube with a first end portion and an opposite, second end portion;

b. forming a cut longitudinally on the tube; and

c. forming a plurality of holes on the tube.

18. The method of claim 17, wherein the tube is made from a bio-compatible material.

19. The method of claim 18, wherein the tube is made from an at least partially transparent material.

20. The method of claim 19, wherein the tube is made from a plastic.

21. The method of claim 17, wherein the step of forming a cut longitudinally on the tube comprises the step of forming the cut substantially extending from the first end to the second end or vice versa.

22. The method of claim 21, further comprising the step of forming a plurality of round edges around the first end and the second end, respectively, after the cut is formed.

23. The method of claim 17, wherein the step of forming a plurality of holes on the tube comprises the step of forming three pairs of holes, and wherein each pair of holes is axially aligned.

24. The method of claim 23, wherein the three pairs of holes are formed substantially parallel to each other and substantially apart from each other in 120°

, as seen from a longitudinal, central axis of the tube.

25. The method of claim 24, wherein when a conduit formed with intestinal tissue is mounted to the conduit holder, further comprising the steps of:

a. guiding a thread through each pair of holes; and

b. tying two corresponding threads from each side for the pair of holes.

26. A heart valve holder or conduit holder made according to the method of claim 17.

27. A heart valve holder or conduit holder, comprising:

a. a tube having a first end portion and an opposite, second end portion;

b. a cut formed longitudinally on the tube; and

c. a plurality of holes formed on the tube.

28. The heart valve holder or conduit holder of claim 27, wherein the tube is made from a bio-compatible material.

29. The heart valve holder or conduit holder of claim 28, wherein the tube is made from an at least partially transparent material.

30. The heart valve holder or conduit holder of claim 29, wherein the tube is made from a plastic.

31. The heart valve holder or conduit holder of claim 27, wherein the cut is formed substantially extending from the first end to the second end or vice versa.

32. The heart valve holder or conduit holder of claim 31, further comprising a plurality of round edges around the first end and the second end, respectively.

33. The heart valve holder or conduit holder of claim 27, wherein the plurality of holes comprises three pairs of holes.

34. The heart valve holder or conduit holder of claim 33, wherein the three pairs of holes are formed substantially parallel to each other and substantially apart from each other in 120°

, as seen from a longitudinal, central axis of the tube.

35. A replacement heart valve device, comprising:

a. a heart valve holder or conduit holder formed in the form of a cylindrical tube having a first end and an opposite, second end; and

b. a heart valve comprising a conduit that has a first end portion, an opposite, second end portion, and a plurality of cusps formed axially extending inwardly from one of the first and second end portions,

wherein in operation, the heart valve is mounted onto the heart valve holder or conduit holder.

36. The replacement heart valve device of claim 35, wherein the conduit is formed with a tubular segment of an elastic material.

37. The replacement heart valve device of claim 36, wherein at least a portion of the conduit is formed with a layer of intestinal tissue.

38. The replacement heart valve device of claim 36, wherein at least a portion of the conduit is formed with two layers of intestinal tissue.

39. The replacement heart valve device of claim 35, wherein the cylindrical tube has a cut formed longitudinally and extending substantially from the first end to the second end of the cylindrical tube, or vice versa.

40. The replacement heart valve device of claim 35, wherein the heart valve holder or conduit holder is formed with a bio-compatible material.

41. The replacement heart valve device of claim 35, wherein the heart valve holder or conduit holder is removable.

42. A method of making a replacement heart valve that is implantable to a patient, comprising the steps of:

a. providing a conduit that has a first end portion, an opposite, second end portion, an interior surface, an exterior surface and a diameter d₁, and a plurality of cusps formed axially extending inwardly from the first end portion;

b. providing a stent that has a first end, an opposite, second end, and a body portion defines a cavity, wherein the body portion is formed with a netted structure;

c. receiving the conduit into the cavity of the stent such that the stent is positioned between the first end portion and the second end portion of the conduit with the first end of the stent closer to the first end portion of the conduit than the second end of the stent to the second end portion of the conduit;

d. attaching the first end of the stent and the first end portion of the conduit to each other;

e. attaching the second end of the stent to the conduit;

f. pulling the second end portion of the conduit inside-out towards to the first end portion of the conduit such that the stent is entirely covered by the corresponding portions of the conduit; and

g. attaching the second end portion of the conduit to the first end portion of the conduit to each other to form a replacement heart valve.

43. The method of claim 42, wherein the conduit is formed of an elastic material.

44. The method of claim 42, wherein the stent formed with a netted structure is a self-expanding stent.

45. The method of claim 42, wherein the step of attaching the first end of the stent and the first end portion of the conduit to each other comprises the step of suturing them together.

46. The method of claim 45, wherein the sewing is performed with 7-0 or 6-0 prolene.

47. The method of claim 42, wherein the step of attaching the second end of the stent to the conduit comprises the step of suturing them together.

48. The method of claim 47, wherein the sewing is performed with 7-0 or 6-0 prolene.

49. The method of claim 42, wherein the step of attaching the second end portion of the conduit to the first end portion of the conduit to each other to form a replacement heart valve comprises the step of suturing them together.

50. The method of claim 47, wherein the sewing is performed with 7-0 or 6-0 prolene.

51. A replacement heart valve implantable in a patient, comprising:

a. a stent that has a first end, an opposite, second end, and a body portion defines a cavity, wherein the body portion is formed with a netted structure;

b. a conduit formed with a tubular segment of an elastic material, wherein the conduit has a first end portion and an opposite, second end portion;

c. a plurality of cusps formed axially extending inwardly from one of the first and second end portions,

wherein a portion of the conduit is received in the cavity of the stent, and one of the first end portion and the second end portion of the conduit is pulled inside-out towards to and attached to another of the first end portion and the second end portion of the conduit such that the stent is entirely covered by the corresponding portions of the conduit.

52. The replacement heart valve of claim 51, wherein the plurality of cusps comprises three cusps formed apart from each other.

53. The replacement heart valve of claim 51, wherein the stent formed with a netted structure is a self-expanding stent.