HOLDERS FOR PROSTHETIC HEART VALVES

• US 20140039609A1
• Filed: 07/23/2013
• Published: 02/06/2014
• Est. Priority Date: 07/31/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Campbell, Louis A., Phung, Andrew
• Granted Patent: US 9,693,862 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

An improved holder and storage system for prosthetic heart valves that pre-shields or pre-constricts the commissure posts of the valve to prevent suture looping. Pre-shielding and pre-constriction mean at the time of manufacture, so that the valves are stored with the commissure posts shielded and/or constricted. The holders may have solid legs that directly contact and constrict and hold the commissure posts without the use of sutures in tension that might creep over the time in storage. The holder may have a base in contact with the inflow end and a shaft portion that projects through the valve leaflets and cooperates with movable legs on the outflow end of the valve in contact with the commissure posts. The holders may, alternatively, have flexible leg members that extend through the valve and have distal end portions configured to extend over and shield the tips of commissure posts.

Claims

1. A valve holder for a prosthetic heart valve, the prosthetic heart valve having an inflow end, an outflow end, and plural commissure posts ending in tips projecting in an outflow direction, the valve holder comprising:

a plurality of angularly spaced, leg members configured to extend at least partially through the prosthetic valve in the outflow direction, the leg members having distal end shielding portions and being moveable between a radially outward position and a radially inward position, wherein when the leg members are in the radially outward position, the distal end portions extend over and shield the tips of the commissure posts and wherein when the leg members are in the radially inward position, the distal end portions are spaced radially inward of the commissure tips and can be withdrawn through the prosthetic valve in a direction toward the inflow end.

2. The valve holder of claim 1, wherein the leg members are biased toward the radially inward portion and the valve holder further comprising an inner shaft that is configured to extend through the leg members and the prosthetic valve so as to push the leg members to the radially outward position, and wherein removal of the shaft from within the leg members allows the leg members to move to the radially inward position.

3. The valve holder of claim 1, wherein the leg members comprise cantilever springs that are normally biased to assume the radially inward position, and the valve holder further comprises a removable inner body member that is insertable into a space between the leg portions to hold the leg portions in the radially outward position in which the distal end portions cover the tips of the commis sure posts.

4. The valve holder of claim 1, wherein the distal end portion of each leg member has a radial thickness that is greater than a proximal portion of the leg member that extends through the prosthetic valve.

5. The valve holder of claim 1, wherein the distal end portion of each leg member comprises a curved, convex distal end surface adapted to shield a respective commissure tip.

6. The valve holder of claim 1, wherein the leg members comprise respective proximal portions connected to a base ring configured to abut the inflow end of the prosthetic valve.

7. A prosthetic heart valve assembly, comprising:

a prosthetic heart valve having an inflow end, an outflow end, and plural commissure posts ending in tips projecting in an outflow direction; and

a valve holder comprising an inner body member and an outer shielding member, the outer shielding member comprising a plurality of angularly spaced, flexible leg members, each having a proximal portion extending through the prosthetic valve and a distal end portion disposed over a tip of a corresponding commissure post, the inner body member comprising a shaft extending through the leg members and retaining the leg members in a radially outward position in which the distal end portions cover the tips of the commissure posts, and wherein removal of the shaft from the leg portions in a direction toward the inflow end of the prosthetic valve allows the leg members to flex to a radially inward position away from the tips of the commissure posts to allow the leg members to be withdrawn through the prosthetic valve in a direction toward the inflow end.

8. The prosthetic valve assembly of claim 7, wherein the prosthetic heart valve includes bioprosthetic leaflets and the assembly is contained in a sterile package in a dry state.

9. The prosthetic valve assembly of claim 7, wherein the distal end portions have a radial thickness that is greater than the proximal portions of the leg members.

10. The prosthetic valve assembly of claim 7, wherein the shielding member comprises a base ring adjacent the inflow end of the prosthetic valve, the leg members being connected to and extending from the base ring toward the outflow end of the prosthetic valve, the shaft comprising a radially projecting tab configured to engage the base ring and cause the shielding member to be retracted from the prosthetic valve when the shaft is moved in a direction toward the inflow end of the prosthetic valve.

11. The prosthetic valve assembly of claim 7, wherein the shielding member comprises a base ring abutting the inflow end of the prosthetic valve, the leg members being connected to and extending from the base ring toward the outflow end of the prosthetic valve, the inner body member comprises a proximal base portion, the shaft being connected to and extending from the base portion, the base portion abutting the base ring of the shielding member and being releaseably connected to the inflow end of the prosthetic valve.

12. The prosthetic valve assembly of claim 11, wherein the base portion of the inner body member is sutured to the inflow end of the prosthetic valve.

13. The prosthetic valve assembly of claim 7, wherein the commissure posts are in a non-deflected, functional position.

14. The prosthetic valve assembly of claim 7, wherein the valve holder comprises a handle and a main shaft having a proximal end portion connected to the handle and a distal end portion connected to the inner body member.

15. A method of implanting a prosthetic heart valve, comprising:

providing a prosthetic heart valve assembly comprising a prosthetic heart valve having an inflow end, an outflow end, and plural commissure posts ending in tips projecting in an outflow direction; and

a valve holder comprising an inner body member and an outer shielding member, the outer shielding member comprising a plurality of angularly spaced, flexible leg members, each having a proximal portion extending through the prosthetic valve and a distal end portion disposed over a tip of a corresponding commissure post, the inner body member comprising a shaft extending through the leg members and retaining the leg members in a radially outward position in which the distal end portions cover the tips of the commissure posts;

delivering and securing the prosthetic valve to a native valve annulus in the heart; and

retracting the inner body member through the inflow end of the prosthetic valve, causing the leg members to flex radially inwardly away from the commissure posts, and then retracting the shielding member through the inflow end of the prosthetic valve.

16. The method of claim 15, wherein delivering and securing the prosthetic valve further comprises securing a plurality of sutures to the native annulus, threading the sutures through a sewing ring of the prosthetic valve, and sliding the prosthetic valve assembly along the sutures until the prosthetic valve seats against the native valve annulus, wherein the distal end portions prevent the sutures from contacting the tips of the commissure posts.

17. The method of claim 15, wherein each distal end portion comprises a wedge-shaped portion that is radially thicker compared to the rest of the leg member.

18. The method of claim 15, wherein the prosthetic heart valve is secured to the native mitral annulus.

19. The method of claim 15, wherein during the act of delivering and securing the prosthetic valve, the commissure posts are in a non-deflected, functional state.

20. The method of claim 15, wherein the inner body member comprises a radially projecting tab portion and retracting the inner body member causes the tab portion to engage a base ring of the shielding member, thereby also retracting the shielding member from the prosthetic valve.

21. The method of claim 15, wherein the prosthetic heart valve comprises dry bioprosthetic leaflets and the act of providing a prosthetic heart valve assembly comprises providing a sterile package containing the prosthetic heart valve assembly stored in a dry state and removing the prosthetic heart valve assembly from the package.

22. A method of packaging a prosthetic heart valve, comprising:

providing a prosthetic heart valve having an inflow end, an outflow end, and plural commissure posts ending in tips projecting in an outflow direction;

providing a shielding member comprising a plurality of flexible leg members, each having a distal end portion;

inserting the leg members into the inflow end of the prosthetic valve until the distal end portions are distal to the tips of the commissure posts;

bending the leg members radially outward such that the distal end portions cover the tips of the commis sure posts; and

packaging the prosthetic heart valve and the shielding member for storage and/or shipping.

23. The method of claim 22, wherein the prosthetic valve comprises tissue leaflets and the prosthetic valve and the shielding member are stored in a dry state.

24. The method of claim 22, wherein bending the leg members comprises inserting an inner body member coaxially through the shielding member, the inner body member causing the leg members to bend radially outwardly.