Heart valve holder and method for resisting suture looping

• US RE47,065 E1
• Filed: 08/11/2016
• Issued: 10/02/2018
• Est. Priority Date: 12/21/2000
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Stobie, Robert, Kafesjian, Ralph, Nguyen-Thien-Nhon, Diana, Lister, Robert Ian, Skoskiewicz, Andrzej, James, Adrian Benton, Sklar, Aaron Ernesto, Banerjee, Banny
• Primary Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US15/234,976
• Time in Patent Office: 782 Days
• 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 method for implanting a tissue-type prosthetic mitral heart valve that prevents suture looping and ma y also constrict the commissure posts of the valve. An upstanding or shaft member axially positioned on the holder causes the lengths of attachment sutures to extend axially beyond the commissure post tips to create a tent and prevent looping of any of an array of pre-implanted sutures around the tips during deployment of the valve. The shaft member may be axially movable such that it can be initially retracted and then actuated just prior to valve deployment. The shaft member may have notches on its distal tip for capturing the attachment sutures, which are crossed over along the valve axis to ensure engagement by the notches. The attachment sutures may be strands or filaments, or may be wider bands of flexible biocompatible material. If bands are used, they desirably cover the commissure post tips to further help prevent suture looping thereover. The flexible lengths of material extend directly between commissures of the valve, or may extending radially inward from each commissure to a central upstanding member.

Claims

1. A holder for a flexible leaflet prosthetic heart valve that helps prevent suture looping, the heart valve having an inflow end and an outflow end and a flow axis therebetween, the valve including a plurality of generally axially-extending commissure posts circumferentially-spaced around the outflow end that support occluding flexible leaflets of the valve, the holder comprising:

a valve abutment portion that contacts the inflow end of the valve;

a member coupled to the valve abutment portion and extending therefrom along the flow axis to a distal tip of the member on the outflow side of the leaflets; and

a plurality of lengths of flexible material each having first segments angled in the outflow direction from the commissure posts to the distal tip of the member in a tent configuration to help prevent suture looping during implant.

2. The holder of claim 1, wherein each first segment of the lengths of flexible material is angled in the outflow direction about 40°

with respect to a radial plane.

3. The holder of claim 1, wherein the member is axially movable relative to the valve abutment portion between a first position wherein the distal tip of the member is located to the inflow side of the leaflets, and a second position wherein the distal tip is located to the outflow side of the leaflets.

4. The holder of claim 1, wherein the valve is of the type that has three leaflets and three commissure posts, and in the first position of the member each first segment extends radially inward and mutually crosses over the other two first segments to retain the point at which they cross over along the flow axis of the valve.

5. The holder of claim 1, wherein the member is solid and includes notches on its distal tip for capturing and retaining midpoints of the first segments of the lengths of flexible material, each first segment angling from one of the commissure posts radially inward to the distal tip of the member and then radially outward to an adjacent commissure post via a notch in the distal tip.

6. The holder of claim 5, wherein each length of flexible material axially extends in second segments along two adjacent commissure posts and attaches to the valve abutment portion at two points such that each length may be severed close to one of its points of attachment to the valve abutment portion and pulled free of the valve along with the valve abutment portion by virtue of its remaining attachment point.

7. The holder of claim 1, further including a generally radially extending clip adapted to removably attach to the valve abutment portion and a generally tubular cage that snaps on to the clip and surrounds the valve to provide protection for the valve during storage, transport, and handling prior to implantation.

8. The holder of claim 7, wherein the cage is perforated to permit rinsing of the valve prior to removal of the cage from the clip.

9. A method for delivering a flexible leaflet prosthetic heart valve and preventing suture looping, comprising:

providing a flexible leaflet prosthetic heart valve and holder combination, the heart valve having an inflow end and an outflow end and a flow axis therebetween, the valve including a plurality of generally axially-extending commissure posts circumferentially-spaced around the outflow end that support occluding flexible leaflets of the valve, the holder being releasably attached at the inflow end of the valve with a plurality of lengths of flexible material each passing through the valve and having two first segments that each extend radially inward from a commissure post to the flow axis, the holder having a member that is axially movable relative to the valve along the flow axis between a first position and a second position displaced from the first position in the outflow direction, the member having a distal tip; and

axially displacing the member from the first position to the second position so that the member distal tip passes from the inflow to the outflow side of the flexible leaflets of the valve and engages the first segments of the plurality of lengths of flexible material so that they are angled in the outflow direction from the commissure posts to the distal tip of the member and help prevent suture looping during implant.

10. The method of claim 9, wherein the valve is of the type that has three leaflets and three commissure posts, and in the first position of the member the first segments of each length of flexible material extends radially inward and mutually crosses over the other two first segments to retain the point at which they cross over along the flow axis of the valve, the member including at least one notch on its distal tip and the method including capturing the first segments in the notch when axially displacing the member from the first position to the second position.

11. The method of claim 9, wherein the commissure posts are flexible, the method further including pulling the commissure posts radially inward when axially displacing the member from the first position to the second position.

12. The method of claim 11, wherein the method includes pulling the commissure posts radially inward such that the diameter of a circle defined by tips of the pulled in commissure posts reduces to about 50-60% of a circle defined by the commissure post tips before being pulled inward.

13. The method of claim 9, wherein the holder includes a valve abutment portion that contacts the inflow end of the valve, and the holder includes structure that prevents axial displacement of the member from its first position with respect to the valve abutment portion.

14. The method of claim 13, further including preventing rotation of the member with respect to the valve abutment portion when axially displacing the member from the first position to the second position.

15. The method of claim 9, further including locking the member in its second position.

16. The method of claim 9, wherein the holder includes a valve abutment portion that contacts the inflow end of the valve and a handle interface attached to the valve abutment portion with at least one thread, the handle interface having structure for coupling to a surgical delivery handle, the method including quickly releasing the handle interface and coupled surgical delivery handle from the valve abutment portion by severing the thread.

17. A system for holding a flexible leaflet prosthetic heart valve, the heart valve having an inflow/proximal end and an outflow/distal end and a flow axis therebetween, the valve including a plurality of generally axially-extending commissure posts circumferentially-spaced around the outflow end that support occluding flexible leaflets of the valve, the system comprising:

a surgical delivery handle having a distal threaded end; and

a holder comprising a valve abutment portion that contacts the inflow end of the valve, and a handle interface having threading for coupling to the distal threaded end of the surgical delivery handle, the handle interface being coupled to the valve abutment portion with quick release structure to permit quick release of the handle interface and coupled surgical delivery handle from the valve abutment portion without having to unscrew the surgical delivery handle,

wherein the quick release structure comprises at least one thread coupling the handle interface and the valve abutment portion, wherein the handle interface and coupled surgical delivery handle are released from the valve abutment portion upon severing the thread.

18. A system for holding a flexible leaflet prosthetic heart valve, the heart valve having an inflow/proximal end and an outflow/distal end and a flow axis therebetween, the valve including a plurality of generally axially-extending commissure posts circumferentially-spaced around the outflow end that support occluding flexible leaflets of the valve, the system comprising:

a surgical delivery handle having a distal threaded end;

a holder comprising a valve abutment portion that contacts the inflow end of the valve, and a handle interface having threading for coupling to the distal threaded end of the surgical delivery handle, the handle interface being coupled to the valve abutment portion with quick release structure to permit quick release of the handle interface and coupled surgical delivery handle from the valve abutment portion without having to unscrew the surgical delivery handle;

a plurality of lengths of flexible material secured to the valve abutment portion and passing through the valve to cross over the outflow end of the valve from the commissure posts to a location along the flow axis and help prevent suture looping during implant; and

a member coupled to the valve abutment portion and extending therefrom along the flow axis to a distal tip on the outflow side of the leaflets, the distal tip engaging the plurality of lengths of flexible material to angle them in the outflow direction from the commissure posts to the distal tip of the member in a tent configuration to help prevent suture looping during implant, wherein the member couples between the valve abutment portion and the handle interface.

19. The system of claim 18, wherein the valve abutment portion comprises a tubular body defining a bore for receiving the member and the member defines a bore for receiving the handle interface.

20. The system of claim 19, wherein the member comprises a generally tubular body and an outwardly extending flange on a proximal end of the body, and the handle interface comprises a generally tubular body and an outwardly extending flange on a proximal end, wherein the handle interface tubular body fits concentrically within the member tubular body and both flanges include coupling holes that align for passage of at least one coupling thread.

21. The system of claim 19, wherein the member is axially movable relative to the valve abutment portion between a first position wherein the distal tip of the member is located to the inflow side of the leaflets, and a second position wherein the distal tip is located to the outflow side of the leaflets.

22. The system of claim 21, wherein the member comprises a generally tubular body having structure for axially restraining the member in the second position with respect to the valve abutment portion.