Prosthetic heart valve, system, and method

• US 9,980,816 B2
• Filed: 03/19/2015
• Issued: 05/29/2018
• Est. Priority Date: 05/10/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Cao, Hengchu, Conklin, Brian S., Schmidt, Paul A., Kim, Grace M., Davidson, James A., Tran, Hoa T., Tam, Kristy L.
• Primary Examiner(s): Dang, Son
• Application Number:
  US14/663,101
• Publication Number:
  US 20150230922A1
• Time in Patent Office: 1,167 Days
• 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. Examples of delivery systems and methods for deploying the valves exhibit reduced patient trauma.

Claims

1. 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, wherein the prosthetic valve further comprises a plurality of cantilevered commissure posts 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 cantilevered commissure portions is positioned radially inward of the sewing ring, and wherein each of the plurality of commissure posts extends radially outward of the sewing ring in 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.

2. The delivery system of claim 1, 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.

3. The delivery system of claim 2, wherein the holder is further configured to collapse the valve to the collapsed delivery configuration.

4. The delivery system of claim 3, wherein the collapsed delivery configuration comprises one or both of a longitudinally collapsed configuration and a radially collapsed configuration.

5. The delivery system of claim 2, wherein the delivery device is further configured to release the frame from the collapsed delivery configuration.

6. The delivery system of claim 2, 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.

7. The delivery system of claim 6, 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.

8. The delivery system of claim 1, wherein the frame comprises a super-elastic alloy.

9. The delivery system of claim 1, wherein the collapsed delivery configuration comprises one or both of a longitudinally collapsed configuration and a radially collapsed configuration.

10. The delivery system of claim 1, wherein the delivery device comprises a handle at a proximal end and a valve holder at an opposing distal end, and the valve holder comprises a central hub and a plurality of angularly spaced leg portions extending therefrom, wherein each leg portion is aligned radially outside of and bears against a respective commissure post so as to retain the commissure post in a longitudinal collapsed position.

11. The delivery system of claim 1, wherein the frame, in the collapsed deployment configuration, is configured to be at least partially collapsed radially.

12. The delivery system of claim 1, wherein, when in the collapsed deployment configuration, the commissure portions are held in place using one or more connecting sutures secured to legs on the valve holder, and the valve is at least partially released from the collapsed delivery configuration by severing the connecting suture(s).

13. The prosthetic-valve delivery system of claim 1, wherein the delivery device comprises a suture configured to at least partially guide the valve to the implantation site during delivery.

14. A method of using the prosthetic-valve delivery system of claim 1, the method comprising:

retaining the prosthetic valve in its collapsed delivery configuration;

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

inserting the collapsed prosthetic valve through the incision using the delivery device;

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

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

15. The method of claim 14, 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.

16. The method of claim 14, wherein the valve comprises the plurality of cantilevered 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.

17. The method of claim 14, wherein the valve is released from the collapsed delivery configuration after the sewing ring has been secured to the surrounding tissue.

18. The method of claim 14, wherein the valve is at least partially released from the collapsed delivery configuration before the sewing ring has been secured to the surrounding tissue.

19. The method of claim 14, 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.

20. 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 including convex cusp portions on an inflow end thereof intermediate convex commissure portions on an outflow end thereof, the resilient frame being made from a super elastic alloy to permit 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 including a valve holder on a distal end of a shaft, wherein the commissure portions of the resilient frame are also folded inwardly to a longitudinally collapsed position when the valve is positioned in the collapsed delivery configuration and held in place with legs on the valve holder wherein, when in the collapsed delivery configuration, the valve is retained in a radially collapsed configuration using a suture or wire threaded through opposing locations around the valve, pulled taught and secured to the valve holder to cause the valve to collapse radially so that the resilient frame defines an oval prism, rather than a cylinder or a circular prism, and the valve is at least partially released from the collapsed delivery configuration by severing the suture or wire.

21. The delivery system of claim 20, wherein the valve holder comprises a central hub and a plurality of angularly spaced leg portions extending therefrom, and wherein each leg portion is aligned radially outside of and bears against a respective commissure post so as to retain the commissure post in the longitudinally collapsed position.

22. The delivery system of claim 20, wherein the legs on the valve holder are secured to the commissure portions of the resilient frame with one or more connecting sutures, and valve is at least partially released from the collapsed delivery configuration by severing the connecting suture(s).