Implantable prosthetic valve assembly and method of making the same

• US 8,236,045 B2
• Filed: 12/22/2006
• Issued: 08/07/2012
• Est. Priority Date: 12/22/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Benichou, Netanel, Spenser, Benjamin, Bash, Assaf
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US11/644,517
• Publication Number:
  US 20080154355A1
• Time in Patent Office: 2,055 Days
• Field of Search: 623 124- 126, 623/2.1, 623/2.11
• US Class Current: 623/1.26
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

An implantable prosthetic valve assembly having a support stent, or frame, having circumferential struts with multiple bends forming obtuse angles when the valve assembly is expanded to its functional size. The frame can be manufactured with one or more of the circumferential struts in a partially collapsed state and a flexible valve member can be mounted to the partially collapsed frame. The partially collapsed struts can be formed with multiple bends having angles selected to facilitate crimping of the frame to a profile suitable for percutaneous delivery. When the frame is expanded, the bends can expand to form obtuse angles, thereby enhancing the rigidity of the frame to better resist closing forces exerted on the valve assembly.

Claims

1. A method comprising connecting a valve member to an inner surface of a frame of an implantable prosthetic valve assembly, the frame being balloon-expandable and having an expanded state suitable for implant and a crimped state suitable for delivery, the method including connecting the valve member to the frame while a portion of the frame is partially crimped to a size between its expanded and its crimped states, the partially crimped frame portion having a diameter that is less than the diameter of the valve member when the valve member is expanded to its functional size, wherein the frame comprises a plurality of angularly-spaced, axial struts and a plurality of circumferential struts connected to the axial struts and extending circumferentially, each circumferential strut having multiple bends with each bend having an obtuse angle when the frame is radially expanded to a deployed state.

2. The method of claim 1, wherein the act of connecting the valve member to an inner surface of the frame comprises connecting the valve member to the partially crimped frame portion so as to place the valve member in a partially crimped state connected to the frame.

3. The method of claim 2, wherein the act of connecting the valve member to the partially crimped frame portion comprises folding the valve member to form multiple angularly-spaced, radially extending folds and connecting apexes of the folds to the frame.

4. The method of claim 2, wherein the act of connecting the valve member to an inner surface of the frame comprises:

attaching a flexible skirt to an inner surface of the partially crimped frame portion at angularly spaced locations on the frame portion such that the skirt substantially conforms to the inner surface of the frame portion when the frame portion is radially expanded to a deployed state; and

attaching a portion of the valve member to an inner surface of the flexible skirt such that the attached portion of the valve member substantially conforms to the inner surface of the skirt when the frame portion is radially expanded to the deployed state.

5. The method of claim 4, wherein the flexible skirt is formed with a generally saw-tooth shaped edge with apexes.

6. The method of claim 4, wherein the act of attaching a flexible skirt to an inner surface of the partially crimped frame portion comprises folding the skirt to form multiple angularly-spaced, radially extending folds in the skirt and attaching apexes of the folds to the frame.

7. The method of claim 6, wherein the act of folding the skirt comprises placing the skirt around posts of a folding tool, and moving some of the posts radially inwardly toward each other to form the folds of the skirt.

8. The method of claim 1, wherein each bend has an angle of about 120 degrees or greater when the frame is radially expanded to a deployed state.

9. The method of claim 8, wherein each circumferential strut comprises a plurality of linear strut members connected to each other at non-zero angles to form the multiple bends of the strut.

10. The method of claim 1, wherein:

the partially crimped frame portion comprises a first frame portion and the frame comprises a second frame portion connected end-to-end to the first frame portion; and

the act of connecting the valve member to an inner surface of the frame comprises connecting the valve member to the second frame portion when the second frame portion is in an expanded state.

11. The method of claim 10, wherein:

the first and second frame portions each comprises a plurality of angularly-spaced, axial struts and a plurality of circumferential struts attached to the axial struts and extending circumferentially of the frame, each of the circumferential struts having multiple bends; and

wherein when both the first and second frame portions are in expanded states, the angles of the bends of the first frame portion are greater than that of the second frame portion.

12. The method of claim 1, wherein the partially crimped frame portion has a first diameter, the method further comprising:

after connecting the valve member to the partially crimped frame portion, storing the heart valve assembly with the frame portion in the partially crimped state;

compressing the valve assembly to a collapsed state having second diameter that is less than the first diameter just prior to implantation;

delivering the heart valve assembly to a native valve site of a patient through the patient'"'"'s vasculature; and

expanding the heart valve assembly at the native valve site to an expanded state having a third diameter that is greater than the first diameter.

13. The method of claim 12, wherein the act of connecting the valve member to the frame comprises bending the valve member into an undulated shape having a diameter that is less than an expanded diameter of the valve member when expanded to its functional size, placing the frame around the bent valve member, and connecting the valve member to the frame at spaced-apart locations on the frame such that when the valve assembly is expanded, the portion of the valve member connected to the frame substantially conforms to the inner surface of the frame.

14. The method of claim 12, wherein the third diameter is approximately at least 1.5 times greater than the first diameter.

15. The method of claim 12, wherein the first diameter is approximately at least twice the second diameter.

16. The method of claim 12, wherein the valve assembly is compressed on the tip portion of a delivery catheter and the act of delivering the valve assembly comprises advancing the delivery catheter through the patient'"'"'s vasculature until the valve assembly is positioned at the native valve site.

17. The method of claim 1, wherein the act of connecting the valve member to the inner surface comprises bending the valve member with a folding apparatus configured to fold the valve member into an undulated shape having multiple angularly-spaced, radially extending folds and a diameter that is less than the expanded diameter.

18. The method of claim 17, wherein the apparatus comprises:

a base;

a plurality of stationary posts connected to the base at fixed locations, the stationary posts being angularly spaced about a center point on the base located centrally between the posts; and

a plurality of moveable posts connected to the base at angularly spaced positions around the center point, the moveable posts being moveable relative to the base radially inwardly toward each other and the center point and radially outwardly away from each other and the center point;

wherein when the valve member is placed around the posts with the valve member extending around outer sides of the stationary posts and inner sides of the moveable posts, moving the moveable posts radially inwardly toward each other folds the valve member.

19. The method of claim 1, wherein the frame portion is formed in the partially crimped state.

20. The method of claim 1, further comprising:

after connecting the valve member to the frame, crimping the valve assembly to a delivery diameter that is less than the diameter of the frame portion when it is being connected to the valve member;

delivering the valve assembly to a native valve site; and

expanding the valve assembly at the native valve site to an expanded state having a diameter that is greater than the diameter of the frame portion when is it being connected to the valve member.

21. The method of claim 1, wherein the diameter of the frame in its partially crimped state is about two times greater than the diameter of the frame in its crimped state, and the diameter of the frame in its expanded state is about 1.5 times greater than the diameter of the frame in its partially crimped state.

22. The method of claim 21, wherein the diameter of the frame in its expanded state is about 23 mm, the diameter of the frame in its partially crimped state is about 15 mm, and diameter of the frame in its crimped state is about 7 mm.

23. The method of claim 1, wherein the frame comprises a plurality of angularly-spaced, axial struts and a plurality of circumferential struts connected to the axial struts and extending circumferentially, each circumferential strut having multiple bends that define angles α

₁ in the partially crimped state and obtuse angles α

₂ when the frame is in its expanded state, and wherein 90°

<

α

₂≦

179°

.

24. The method of claim 23, wherein 90°

<

α

₂≦

130°

.

25. The method of claim 24, wherein α

₂ is about 120°

.

26. The method of claim 1, wherein the circumferential struts each define angles α

₁ in the partially crimped state and obtuse angles α

₂ when the frame is in its expanded state, and wherein 50°

≦

α

₁≦

90°

.

27. The method of claim 26, wherein α

₁ is about 70°

.

28. The method of claim 1, wherein the circumferential struts each define angles α

₁ in the partially crimped state and obtuse angles α

₂ when the frame is in its expanded state, and wherein 90°

<

α

₂≦

179°

.

29. The method of claim 28, wherein 90°

<

α

₂≦

130°

.

30. The method of claim 29, wherein α

₂ is about 120°

.

31. The method of claim 1, wherein the frame of an implantable prosthetic valve assembly is balloon-expandable.

32. The method of claim 31, wherein the frame material is selected from the group consisting of stainless steel and titanium.

33. A method of assembling an implantable prosthetic valve, comprising:

providing a flexible valve member having a functional size;

providing a balloon-expandable frame having an expanded state suitable for implant and a crimped state suitable for delivery, a portion of the frame being formed in a partially crimped state having a size between its expanded and its crimped states; and

connecting the flexible valve member to an inner surface of the portion of the frame that is partially crimped, the partially crimped frame portion having a diameter that is less than the functional size of the valve member.

34. The method of claim 33, wherein the act of connecting the valve member to an inner surface of the frame comprises:

attaching a flexible skirt to an inner surface of the partially crimped frame portion at angularly spaced locations on the frame portion such that the skirt substantially conforms to the inner surface of the frame portion when the frame portion is radially expanded to a deployed state; and

attaching a portion of the valve member to an inner surface of the flexible skirt such that the attached portion of the valve member substantially conforms to the inner surface of the skirt when the frame portion is radially expanded to the deployed state.

35. The method of claim 34, wherein the act of attaching a flexible skirt to an inner surface of the partially crimped frame portion comprises folding the skirt to form multiple angularly-spaced, radially extending folds in the skirt and attaching apexes of the folds to the frame.

36. The method of claim 34, wherein the flexible skirt is formed with a generally saw-tooth shaped edge with apexes.

37. The method of claim 33, wherein the act of folding the skirt comprises placing the skirt around posts of a folding tool, and moving some of the posts radially inwardly toward each other to form the folds of the skirt.

38. The method of claim 33, wherein the diameter of the frame in its partially crimped state is about two times greater than the diameter of the frame in its crimped state, and the diameter of the frame in its expanded state is about 1.5 times greater than the diameter of the frame in its partially crimped state.

39. The method of claim 38, wherein the diameter of the frame in its expanded state is about 23 mm, the diameter of the frame in its partially crimped state is about 15 mm, and diameter of the frame in its crimped state is about 7 mm.

40. The method of claim 33, wherein the act of connecting the valve member to the partially crimped frame portion comprises folding the valve member to form multiple angularly-spaced, radially extending folds and connecting apexes of the folds to the frame.

41. The method of claim 33, wherein the frame comprises a plurality of angularly-spaced, axial struts and a plurality of circumferential struts connected to the axial struts and extending circumferentially of the frame, each circumferential strut having multiple bends with each bend having an angle of about 120 degrees or greater when the frame is radially expanded to a deployed state.

42. The method of claim 33, wherein:

the partially crimped frame portion comprises a first frame portion and the frame comprises a second frame portion connected end-to-end to the first frame portion; and

the act of connecting the valve member to an inner surface of the frame comprises connecting the valve member to the second frame portion when the second frame portion is in an expanded state.

43. The method of claim 42, wherein:

the first and second frame portions each comprises a plurality of angularly-spaced, axial struts and a plurality of circumferential struts attached to the axial struts and extending circumferentially of the frame, each of the circumferential struts having multiple bends; and

wherein when both the first and second frame portions are in expanded states, the angles of the bends of the first frame portion are greater than that of the second frame portion.

44. The method of claim 33, wherein the frame comprises a plurality of angularly-spaced, axial struts and a plurality of circumferential struts connected to the axial struts and extending circumferentially, each circumferential strut having multiple bends that define angles α

₁ in the partially crimped state and obtuse angles α

₂ when the frame is in its expanded state.

45. The method of claim 44, wherein 50°

≦

α

₁≦

90°

.

46. The method of claim 44, wherein α

₁ is about 70°

.