Prosthetic heart valve

• US 8,986,374 B2
• Filed: 05/10/2011
• Issued: 03/24/2015
• Est. Priority Date: 05/10/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Cao, Hengchu, Conklin, Brian, Schmidt, Paul, Kim, Grace Myong, Davidson, James A., Tran, Hoa Trinh, Tam, Kristy Luong
• Primary Examiner(s): Shay, Randy
• Application Number:
  US13/104,648
• Publication Number:
  US 20110276128A1
• Time in Patent Office: 1,414 Days
• Field of Search: 623/2.1, 623/2.12, 623/2.18
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

Disclosed prosthetic valves can comprise a sewing ring configured to secure the valve to an implantation site. Some disclosed valves comprise a resiliently collapsible frame having a neutral configuration and a collapsed deployment configuration. Some disclosed frames can self-expand to the neutral configuration when released from the collapsed deployment configuration. Collapsing a disclosed valve can provide convenient access to the sewing ring, such as for securing the valve to the implantation site, as well as for the insertion of the valve through relatively small surgical incisions.

Claims

1. A prosthetic valve comprising:

a plurality of valve leaflets;

a collapsible, self-expandable frame assembly configured to support the valve leaflets and defining a plurality of commissure portions, wherein the self-expandable frame assembly comprises an undulating continuous elongated wireform member alternately defining convex cusp portions on an inflow end thereof intermediate convex commissure portions on an outflow end thereof, made from a super elastic alloy such that each of the commissure portions is configured to be folded radially inward to a longitudinally collapsed position for delivery of the valve to an implantation site within a body lumen; and

a sewing ring comprising an annular suture-permeable member for contacting a surrounding lumen, the sewing ring being attached to the valve at the inflow end and radially outward of the frame assembly cusp portions, wherein the plurality of commissure portions are adapted to be cantilevered and not in contact with the surrounding lumen and configured to move independently of the sewing ring when it is in contact with the surrounding lumen.

2. The prosthetic valve of claim 1, wherein each of the commissure portions is cantilevered relative to the sewing ring such that a commissure tip can move relative to the sewing ring.

3. The prosthetic valve of claim 1, wherein at least one of the commissure portions is configured to be collapsible to a radially collapsed position for delivery of the valve.

4. The prosthetic valve of claim 1, wherein each of the plurality of commissure portions extends radially outward of the cusp portions when the frame assembly is in a neutral configuration.

5. The prosthetic valve of claim 1, wherein each of the leaflets is so configured as to allow the plurality of commissure portions of the frame assembly to flex radially outwardly and inwardly relative to the sewing ring during the cardiac cycle.

6. The prosthetic valve of claim 5, wherein each of the plurality of leaflets defines a corresponding outer periphery with first, second and third regions, wherein each of the first, second and third regions has a corresponding radius-of-curvature, wherein the first and third regions are separated by the second region, and wherein the respective radii-of-curvature of the first and third regions is greater than the radius of curvature of the second region.

7. The prosthetic valve of claim 1, wherein the self-expandable frame assembly comprises:

a first subassembly comprising the continuous elongated wireform member; and

a second subassembly comprising the sewing ring, wherein at least a portion of each of the leaflets is supported between corresponding portions of the first subassembly and the second subassembly.

8. The prosthetic valve of claim 1, wherein the wireform member comprises nitinol.

9. The prosthetic valve of claim 1, wherein the self-expandable frame assembly comprises:

a first subassembly comprising the continuous elongated wireform member that defines the commissure portions; and

a second subassembly comprising the sewing ring and a stent coupled together with fabric, wherein the stent comprises a circumferential base member and a plurality of posts that extend longitudinally therefrom adjacent the plurality of commissure portions, and wherein each stent post may be folded radially inward so as to be longitudinally collapsible along with a corresponding commissure portion.

10. The prosthetic valve of claim 9, wherein the stent is formed of a single polymer piece.

11. The prosthetic valve of claim 9, wherein the stent is formed of silicon.

12. The prosthetic valve of claim 9, wherein the circumferential base member of the stent is separate from a plurality of commissure tips that form the posts.

13. The prosthetic valve of claim 12, wherein the commissure tips are secured to the circumferential base member with sutures.

14. The prosthetic valve of claim 12, wherein the commissure tips are formed of a polymer while the circumferential base member is formed of a super elastic alloy.

15. A prosthetic valve comprising:

a plurality of valve leaflets arranged to provide one-way longitudinal flow through the valve each having an outlet edge opposite an arcuate peripheral edge;

a collapsible, self-expandable frame configured to support the valve leaflets and defining a plurality of convex commissure portions cantilevered in an outflow direction, wherein the self-expandable frame comprises a superelastic alloy such that the frame may be collapsed for delivery of the valve, wherein the frame comprises an undulating continuous elongated wireform defining a plurality of convex cusp portions intermediate the commissure portions; and

a stent subassembly configured to secure the valve to a surrounding lumen, the stent subassembly comprising a stent having a circumferential base member with cusps that coincide with and align longitudinally with respective ones of the frame cusp portions and a plurality of posts that extend longitudinally therefrom adjacent and to an outside of respective ones of the plurality of commissure portions of the frame, the stent subassembly being attached to the self-expandable frame with the arcuate peripheral edges of the valve leaflets being secured between the aligned frame cusp portions and the stent cusps, while the outlet edges attach at their ends to the frame commissure portions and adjacent stent posts, and wherein the stent subassembly may be collapsed in the same manner as the frame for delivery of the valve, and

wherein the valve is expandable toward a neutral configuration and collapsible to a collapsed delivery configuration for delivery of the valve to an implantation site within a body lumen.

16. The prosthetic valve of claim 15, wherein at least one of the commissure portions is configured to be collapsible to a radially collapsed position for delivery of the valve.

17. The prosthetic valve of claim 15, wherein each of the plurality of commissure portions extends radially outward of the cusp portions when the frame is in a neutral configuration.

18. The prosthetic valve of claim 15, wherein each of the plurality of leaflets defines a corresponding outer periphery defining first, second and third regions, wherein each of the first, second and third regions has a corresponding radius-of-curvature, wherein the first and third regions are separated by the second region, and wherein the respective radii-of-curvature of the first and third regions is greater than the radius of curvature of the second region.

19. The prosthetic valve of claim 15, wherein the frame comprises Nitinol.

20. The prosthetic valve of claim 15, wherein each commissure portion of the frame and each stent post of the stent may be folded radially inward to convert the valve to the collapsed delivery configuration.

21. The prosthetic valve of claim 15, wherein the stent is formed of a single polymer piece.

22. The prosthetic valve of claim 15, wherein the stent is formed of silicon.

23. The prosthetic valve of claim 15, wherein the circumferential base member of the stent is separate from a plurality of commissure tips that form the posts.

24. The prosthetic valve of claim 23, wherein the commissure tips are secured to the circumferential base member with sutures.

25. The prosthetic valve of claim 23, wherein the commissure tips are formed of a polymer while the circumferential base member is formed of a super elastic alloy.

26. The prosthetic valve of claim 15, wherein the frame is covered with a cloth cover having opposing longitudinal edges brought into opposing alignment with each other to form a seam, and the stent subassembly is also covered in cloth, wherein the arcuate peripheral edges of the valve leaflets are secured between the aligned frame cusp portions and the stent cusps by sutures that pass through the seam of the frame cloth cover, through the leaflets, and through the cloth covering the stent subassembly.

27. The prosthetic valve of claim 26, further including a sewing ring attached around an outside of the stent subassembly and attached to the cloth covering thereon.

28. The prosthetic valve of claim 15, further including a sewing ring attached around an outside of the stent subassembly for contacting a surrounding lumen.