Methods of delivering and implanting resilient prosthetic surgical heart valves

• US 10,702,383 B2
• Filed: 05/25/2018
• Issued: 07/07/2020
• 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, Phong Son H
• Application Number:
  US15/990,332
• Publication Number:
  US 20180318075A1
• Time in Patent Office: 774 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.

Claims

1. A method of implanting a surgical prosthetic heart valve at a heart valve annulus, wherein the valve comprises a resilient frame including alternating cusp and commissure portions and having a neutral configuration defining a circular prism leaflet support structure, the valve further including a sewing ring around an inflow end of the resilient frame, the valve further including flexible leaflets supported by the leaflet support structure, the method comprising:

retaining the surgical prosthetic heart valve in a collapsed delivery configuration in which the resilient frame defines a non-circular prism, wherein the commissure portions of the resilient frame are folded inwardly toward a longitudinally collapsed position when the valve is positioned in the collapsed delivery configuration;

making an outer incision leading to a body lumen;

making an inner incision in the body lumen to provide direct access to a heart valve annulus;

inserting the valve in the collapsed delivery configuration through the outer and inner incisions and into the body lumen;

advancing the valve to the heart valve annulus;

securing the sewing ring to the heart valve annulus; and

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

2. The method of claim 1, further comprising:

after the step of making an inner incision, securing one or more sutures to the heart valve annulus and extending the one or more of the sutures outwardly through the inner and outer incisions and through the sewing ring of the valve; and

wherein the steps of inserting and advancing include;

sliding the valve along the one or more sutures and through the outer and inner incisions until the sewing ring engages the heart valve annulus.

3. The method of claim 1, wherein the commissure portions of the resilient frame are folded inwardly to a fully longitudinally collapsed position when the valve is positioned in the collapsed delivery configuration.

4. The method of claim 1, wherein the valve is released from the collapsed delivery configuration after the sewing ring has been secured to the heart valve annulus.

5. The method of claim 1, wherein the valve is at least partially released from the collapsed delivery configuration before the sewing ring has been secured to the heart valve annulus.

6. The method of claim 1, 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 heart valve annulus;

the act of securing the sewing ring comprises securing the sewing ring to the heart valve annulus 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.

7. The method of claim 1, wherein the resilient frame comprises a wireform comprising one or more elongate members having a continuous undulating shape with alternating cusps and commissures that define the circular prism leaflet support structure.

8. The method of claim 1, wherein the valve is retained in the radially collapsed configuration using a suture or wire threaded through opposing locations around the valve and pulled taught to cause the valve to collapse radially so that the resilient frame defines the non-circular prism, and the valve is at least partially released from the collapsed delivery configuration by severing the suture or wire.

9. The method of claim 1, wherein the valve is retained in the radially collapsed configuration by pinching the resilient frame at two diametrically opposed locations adjacent the inflow end of the frame.

10. The method of claim 1, wherein the outer incision is a thoracotomy and the inner incision provides direct access to the mitral valve annulus.

11. A method of implanting a surgical prosthetic heart valve at a heart valve annulus, wherein the valve comprises a resilient frame including alternating cusp and commissure portions and having a neutral configuration defining a circular prism leaflet support structure, the valve further including flexible leaflets supported by the leaflet support structure, the method comprising:

retaining the surgical prosthetic heart valve in a collapsed delivery configuration in which the resilient frame defines a substantially oval prism, wherein the commissure portions of the resilient frame are folded inwardly toward a longitudinally collapsed position when the valve is positioned in the collapsed delivery configuration;

making an outer incision leading to a body lumen;

making an inner incision in the body lumen to provide direct access to a heart valve annulus;

inserting the valve in the collapsed delivery configuration through the outer and inner incisions and into the body lumen;

advancing the valve to the heart valve annulus;

releasing the valve from the collapsed delivery configuration such that the valve independently recovers to the neutral configuration; and

securing the valve to the heart valve annulus.

12. The method of claim 11, wherein the valve further includes a sewing ring around an inflow end of the resilient frame, and further comprising:

after the step of making an inner incision, securing one or more sutures to the heart valve annulus and extending the one or more of the sutures outwardly through the inner and outer incisions and through the sewing ring of the valve; and

wherein the steps of inserting and advancing include;

sliding the valve along the one or more sutures and through the outer and inner incisions until the sewing ring engages the heart valve annulus.

13. The method of claim 12, wherein the valve is at least partially released from the collapsed delivery configuration before the sewing ring has been secured to the heart valve annulus.

14. The method of claim 11, wherein the resilient frame comprises a wireform with one or more elongate members having a continuous undulating shape with alternating cusps and commissures that define the circular prism leaflet support structure.

15. The method of claim 14, wherein the commissures of the wireform are folded inwardly to a fully longitudinally collapsed position when the valve is positioned in the collapsed delivery configuration.

16. The method of claim 11, wherein the commissure portions of the resilient frame are folded inwardly to a fully longitudinally collapsed position when the valve is positioned in the collapsed delivery configuration and held in place with legs on a valve holder.

17. The method of claim 16, 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).

18. The method of claim 11, wherein the valve is retained in the radially collapsed configuration using a suture or wire threaded through opposing locations around the valve and pulled taught to cause the valve to collapse radially so that the resilient frame defines the substantially oval prism, and the valve is at least partially released from the collapsed delivery configuration by severing the suture or wire.

19. The method of claim 18, 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 using one or more connecting sutures secured to legs on a valve holder, and the valve is at least partially released from the collapsed delivery configuration by severing the connecting suture(s).

20. The method of claim 11, wherein the valve is retained in the radially collapsed configuration by pinching the resilient frame at two opposed locations adjacent an inflow end of the frame.