Prosthetic Heart Valve

• US 20110276128A1
• Filed: 05/10/2011
• Published: 11/10/2011
• Est. Priority Date: 05/10/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Schmidt, Paul, Kim, Grace Myong, Conklin, Brian, Tam, Kristy Luong, Tran, Hoa Trinh, Davidson, James A., Cao, Hengchu
• Granted Patent: US 8,986,374 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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:

an inflow end and an opposing outflow end defining a valve axis extending longitudinally of the ends;

a plurality of valve leaflets;

a collapsible, self-expandable frame assembly configured to support the valve leaflets and defining a plurality of commissure portions; and

a sewing ring portion configured to secure the valve to a surrounding lumen, wherein the plurality of commissure portions are configured to move independently of the sewing ring when the valve is so secured.

2. The prosthetic valve of claim 1, wherein the sewing ring portion extends circumferentially of the frame in a region positioned between the inflow end and the outflow end.

3. The prosthetic valve of claim 2, wherein the sewing ring portion substantially occupies an annulus within a transverse plane oriented substantially perpendicularly to the valve axis.

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

5. The prosthetic valve of claim 1, wherein the self-expandable frame assembly comprises an elongate wireform frame comprising a super-elastic alloy.

6. The prosthetic valve of claim 1, wherein the valve is expandable and collapsible between a neutral configuration and at least one collapsed delivery configuration for delivery of the valve to an implantation site within a body lumen.

7. The prosthetic valve of claim 6, wherein the at least one collapsed delivery configuration comprises one or both of a longitudinally collapsed configuration and a radially collapsed configuration.

8. The prosthetic valve of claim 7, wherein at least one of the commissure portions is configured to be collapsible to a longitudinally collapsed position for delivery of the valve.

9. The prosthetic valve of claim 7, wherein at least one of the commissure portions is configured to be collapsible to a radially collapsed position for delivery of the valve.

10. The prosthetic valve of claim 6, wherein the frame assembly is configured such that the valve can self-expand from the at least one collapsed delivery configuration to the neutral configuration.

11. The prosthetic valve of claim 4, wherein each of the plurality of commissure portions extends radially outward of the valve axis when the valve is in a neutral configuration.

12. 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 portion during the cardiac cycle.

13. The prosthetic valve of claim 12, 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.

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

a first subassembly comprising an elongate frame portion; and

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

15. The prosthetic valve of claim 5, wherein the elongate wireform frame comprises nitinol.

16. A prosthetic-valve delivery system comprising:

a prosthetic valve being collapsible and expandable between a collapsed delivery configuration and a neutral configuration, the valve comprising a sewing ring configured to be secured to an implantation site, and a resilient frame configured to cause the valve to expand from the collapsed delivery configuration to the neutral configuration; and

a delivery device configured to assist the delivery of the valve to the implantation site when the valve is in the collapsed delivery configuration.

17. The delivery system of claim 16, wherein the delivery device comprises an elongate configuration having a handle at a proximal end and a holder at an opposing distal end, wherein the holder is configured to retain the valve during delivery of the valve to the implantation site.

18. The delivery system of claim 17, wherein the holder is further configured to collapse the valve to the collapsed delivery configuration.

19. The delivery system of claim 17, wherein the delivery device is further configured to release the frame from the collapsed delivery configuration.

20. The delivery system of claim 18, wherein the collapsed delivery configuration comprises one or both of a longitudinally collapsed configuration and a radially collapsed configuration.

21. The delivery system of claim 17, wherein the delivery system comprises one or more actuators being so configured as to cause the holder to release the valve from the collapsed delivery configuration upon actuation of the one or more actuators.

22. The delivery system of claim 21, wherein the delivery device comprises one or more actuators configured to cause the holder to so contract as to collapse the valve to the collapsed delivery configuration.

23. The delivery system of claim 16, wherein the frame comprises a super-elastic alloy.

24. The delivery system of claim 16, wherein the collapsed delivery configuration comprises one or both of a longitudinally collapsed configuration and a radially collapsed configuration.

25. The delivery system of claim 16, wherein the prosthetic valve further comprises a plurality of cantilevered commissure portions extending substantially longitudinally of the valve and being cantilevered relative to the sewing ring in the neutral configuration, wherein, in the collapsed deployment configuration, at least a portion of one of the plurality of commissure posts is positioned radially inward of the sewing ring.

26. The delivery system of claim 25, wherein the frame, in the collapsed deployment configuration, is configured to be at least partially collapsed radially.

27. The delivery system of claim 25, wherein each of the plurality of commissure portions extends radially outward of the sewing ring in the neutral configuration.

28. The prosthetic-valve delivery system of claim 16, wherein the delivery device comprises a suture configured to at least partially guide the valve to the implantation site during delivery.

29. A method of implanting a prosthetic valve at an implantation site within a body lumen, wherein the valve comprises a resilient frame and a sewing ring, wherein the valve is configured to at least partially self-expand to a neutral configuration from a collapsed delivery configuration, the method comprising:

retaining a valve in a collapsed delivery position;

making an incision in a body lumen adjacent an implantation site;

inserting the collapsed valve through the incision;

securing the sewing ring to surrounding tissue within the body lumen; and

releasing the valve from the collapsed delivery configuration such that the valve independently recovers to the neutral configuration within the body lumen.

30. The method of claim 29, further comprising:

securing one or more sutures to tissue adjacent the implantation site and extending the one or more of the sutures outwardly through the incision and through the sewing ring of the prosthetic valve; and

sliding the prosthetic valve along the one or more sutures and through the incision until the prosthetic valve engages the implantation site.

31. The method of claim 29, wherein the valve comprises a plurality of commissure portions, and wherein the commissure portions are folded inwardly to a longitudinally collapsed position when the valve is positioned in the collapsed delivery configuration.

32. The method of claim 29, wherein the valve is released from the collapsed delivery configuration after the sewing ring has been secured to the surrounding tissue.

33. The method of claim 29, wherein the valve is at least partially released from the collapsed delivery configuration before the sewing ring has been secured to the surrounding tissue.

34. The method of claim 29, wherein:

the act of retaining the valve in the collapsed delivery configuration comprises longitudinally and radially collapsing the valve;

the act of releasing the valve from the collapsed delivery configuration comprises allowing the valve to radially expand before the sewing ring has been secured to the surrounding tissue;

the act of securing the sewing ring comprises securing the sewing ring to the surrounding tissue after the valve has radially expanded; and

the act of releasing the valve from the collapsed delivery configuration further comprises allowing the valve to expand longitudinally after the sewing ring has been secured to the surrounding tissue.