Holders for prosthetic heart valves

• US 9,693,862 B2
• Filed: 07/23/2013
• Issued: 07/04/2017
• 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
• Primary Examiner(s): Yabut, Diane
• Assistant Examiner(s): Ton, Martin T
• Application Number:
  US13/948,923
• Publication Number:
  US 20140039609A1
• Time in Patent Office: 1,442 Days
• Field of Search: 623243
• 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 prosthetic heart valve assembly, comprising:

a prosthetic heart valve having an inflow end with a peripheral sewing ring, an outflow end, three commissure posts ending in tips projecting in an outflow direction, and three flexible leaflets supported by the commissure posts that coapt against one another to provide one-way occluding surfaces; and

a valve holder comprising;

a commissure post shielding member having a proximal base ring and three circumferentially spaced leg members extending distally therefrom, each leg member having a length sufficient to extend at least partially through the flexible leaflets of the prosthetic valve in the outflow direction with the base ring positioned against the heart valve sewing ring, each leg member having a distal end portion and being moveable between a radially outward position and a radially inward position, wherein when the leg members are in the radially outward positions the distal end portions extend over and shield the tips of the commissure posts so as to extend over and shield the tips of the commissure posts from suture looping during advancement of the heart valve to a site of implantation, 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, the leg members being biased toward the radially inward position; and

an inner shaft configured to extend through the base ring of the shielding member and between the leg members, the shaft having a shape that contacts the leg members and flexes the distal end portions outward to the radially outward positions, and wherein removal of the shaft in an inflow direction from within the leg members allows the leg members to spring back to the radially inward position, the shaft having a proximal end defining an opening for receiving a delivery tool for manual delivery of the prosthetic heart valve assembly.

2. The assembly 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.

3. The assembly of claim 1, wherein the distal end portion of each leg member comprises a curved, convex distal end surface that faces away from the respective commissure tip that it covers.

4. The assembly of claim 1, wherein the flexible leaflets are bioprosthetic and the assembly is contained in a sterile package in a dry state.

5. The assembly of claim 1, wherein the shaft comprises a radially projecting tab configured to engage the base ring of the shielding member, the tab configured to permit the shaft to be inserted distally through the base ring of the shielding member to move the leg members to the radially outward positions while preventing the shaft from being removed proximally from within the base ring to enable removal of the shielding member with the shaft.

6. The assembly of claim 1, wherein the shaft extends distally from a proximal base portion that abuts the base ring of the shielding member and is releasably connected thereto.

7. The assembly of claim 6, wherein the base portion and base ring are sutured to the inflow end of the prosthetic valve.

8. The assembly of claim 1, wherein when the distal end portions are in their radially outward positions the commissure posts are in non-deflected, functional positions.

9. The assembly of claim 1, wherein the shaft includes a plurality of longitudinally extending, circumferentially spaced slots configured to at least partially receive respective leg members when the leg members flex to their radially inward positions.

10. The assembly of claim 1, wherein the shaft is tapered such that a distal portion has a greater diameter than a proximal portion.

11. A prosthetic heart valve assembly, comprising:

a prosthetic heart valve having an inflow end with a peripheral sewing ring, an outflow end, three commissure posts ending in tips projecting in an outflow direction, and three flexible leaflets supported by the commissure posts that coapt against one another to provide one-way occluding surfaces; and

a valve holder comprising;

a commissure post shielding member having a proximal base ring and three circumferentially spaced leg members extending distally therefrom, each leg member having a length sufficient to extend at least partially through the flexible leaflets of the prosthetic valve in the outflow direction with the base ring positioned against the heart valve sewing ring, each leg member having a distal end portion and being moveable between a radially outward position and a radially inward position, wherein when the leg members are in the radially outward positions the distal end portions extend over and shield the tips of the commissure posts so as to extend over and shield the tips of the commissure posts from suture looping during advancement of the heart valve to a site of implantation, 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, the leg members being biased toward the radially inward position; and

an inner member configured to extend through the base ring of the shielding member and displace the distal end portions of the leg members outward to the radially outward positions, and wherein removal of the inner member in an inflow direction from within the leg members allows the leg members to spring back to the radially inward position, wherein the inner member has a radially projecting tab configured for one-way engagement of the inner member with the shielding member, the tab configured to permit the inner member to be inserted distally through the base ring of the shielding member to move the leg members to the radially outward positions while preventing the inner member from being removed proximally from within the base ring to enable removal of the shielding member along with the inner member.

12. The assembly of claim 11, 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.

13. The assembly of claim 11, wherein the distal end portion of each leg member comprises a curved, convex distal end surface that faces away from the respective commissure tip that it covers.

14. The assembly of claim 11, wherein the flexible leaflets are bioprosthetic and the assembly is contained in a sterile package in a dry state.

15. The assembly of claim 11, wherein the inner member extends distally from a proximal base portion that abuts the base ring of the shielding member and is releasably connected thereto.

16. The assembly of claim 15, wherein the base portion and base ring are sutured to the inflow end of the prosthetic valve.

17. The assembly of claim 11, wherein when the distal end portions are in their radially outward positions the commissure posts are in non-deflected, functional positions.

18. The assembly of claim 11, wherein the inner member comprises a shaft with a plurality of longitudinally extending, circumferentially spaced slots configured to at least partially receive respective leg members when the leg members flex to their radially inward positions.

19. The assembly of claim 18, wherein the shaft is tapered such that a distal portion has a greater diameter than a proximal portion.