Holder for flexible heart valve

• US 20020133226A1
• Filed: 05/03/2001
• Published: 09/19/2002
• Est. Priority Date: 01/26/1999
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Argento, Claudio, Marquez, Salvador, Rhee, Richard S.
• Granted Patent: US 6,736,845 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A holder for a highly flexible tissue-type heart valve is disclosed that maintains an implant shape to the valve. The holder may have cusp and commissure contacting supports, and may be attached at all six such supports, or only three. The holder may be flexible to permit inward flexing of the heart valve during implant for greater visibility when implanting using a running suture method. The holder may be formed of flexible wires such as Nitinol, and shaped to resist excessive axial and torsional deformation of the valve. A short handle connector suitable for manual grasping may be attached and stored with the valve, with the handle connector having a coupling for receiving a longer delivery handle. A two stage holder may be utilized to accommodate different implant methods.

Claims

1. A holder for attaching to and holding a flexible heart valve, the heart valve having multiple leaflets joined together at a periphery of the valve at valve commissures that are generally axially aligned and evenly disposed about a valve axis, the valve commissures each being disposed between adjacent curvilinear valve cusps along the periphery of the valve, the holder comprising:

a plurality of cusp supports arranged around an axis to contact the heart valve generally along the valve cusps; and

a plurality of commissure supports connected to and intermediate each two cusp supports and arranged to abut the valve commissures.

2. The holder of claim 1, wherein the commissure supports are radially flexible enabling the valve commissures to be flexed inward while in contact with the holder commissure supports.

3. The holder of claim 2, wherein the commissure supports are made of Nitinol.

4. The holder of claim 1, further including at least one leg extending radially inward from a cusp support to a location surrounded by the plurality of cusp supports.

5. The holder of claim 4, further including multiple legs extending radially inward from each cusp support and being attached together at a common location.

6. The holder of claim 5, wherein the common location is on the axis of the holder that coincides with the valve axis when the holder and valve are attached.

7. The holder of claim 6, further including a connector extending along the holder axis to which the legs join, the connector having a coupling for receiving a handle for the holder and having a length suitable for manually grasping.

8. The holder of claim 7, wherein the connector is formed separately from the legs and joined thereto.

9. The holder of claim 5, wherein the legs are formed separately from the cusp supports and joined thereto.

10. The holder of claim 1, wherein the cusp supports are multiple pieces joined together.

11. The holder of claim 10, wherein each piece includes two halves of adjacent cusp supports and a commissure support.

12. The holder of claim 11, further including multiple legs extending radially inward from each cusp support and being attached together at a common location, each piece having two leg halves extending radially inward from each of its cusp support halves, wherein each pair of adjacent leg halves makes up one of the holder legs.

13. The holder of claim 1, further comprising:

a central hub with a plurality of radially outward upper legs connected to the commissure supports, and a plurality of lower legs angled downward and outward connected to the cusp supports.

14. The holder of claim 13, wherein each lower leg has a width from the hub to a terminal end that is greatest at the terminal end to provide more surface area to contact the corresponding valve cusp.

16. The combination of claim 15, wherein the holder includes structure for substantially preventing torsional deformation of the flexible heart valve during implantation.

17. The combination of claim 15, wherein the holder further includes:

a valve contacting portion having a generally continuous curvilinear structure conforming to the periphery of the valve and defining the alternating cusp and commissure supports.

18. The combination of claim 17, wherein the holder includes a central hub with a plurality of legs angled downward and outward connected to the cusp supports.

19. The combination of claim 18, wherein the valve contacting portion is integrally formed separate from the legs.

20. The combination of claim 18, wherein the valve contacting portion is formed of a plurality of separate pieces, each piece defining at least a part of one of the legs.

21. The combination of claim 20, wherein each separate piece defines a half of two adjacent cusp supports.

22. The combination of claim 21, wherein each separate piece is formed of a wire.

23. The combination of claim 15, further including:

commissure attachment sutures connecting the commissure supports to the valve commissures.

24. The combination of claim 23, wherein the flexible heart valve includes a sewing band that generally conforms to the valve cusps and commissures, wherein the commissure attachment sutures connect the commissure supports to the sewing band at the valve commissures.

25. The combination of claim 15, wherein the holder further includes:

a valve contacting portion having a generally continuous curvilinear structure conforming to the periphery of the valve and defining the alternating cusp and commissure supports, wherein the commissure attachment sutures are severable at the commissure supports and wherein the commissure supports include leaflet guard sections that structurally protect the valve leaflets from being cut by a blade in severing the commissure attachment sutures.

26. The combination of claim 15, further including:

cusp attachment sutures connecting the cusp supports to the valve cusps.

27. The combination of claim 26, wherein the flexible heart valve includes a sewing band that generally conforms to the valve cusps and commissures, wherein the cusp attachment sutures connect the cusp supports to the sewing band at the valve cusps.

28. The combination of claim 26, wherein the cusp attachment sutures are routed so as to cross a common cut point on the holder such that the plurality of attachments between the cusp supports and valve cusps can be severed with one cut.

29. The combination of claim 28, wherein the holder includes a central hub with a plurality of legs angled downward and outward connected to the cusp supports, and wherein the cusp attachment sutures each loop through the valve at the valve cusps with one segment being tied to the cusp support and a second segment extending up the corresponding leg to the hub, across the common cut point.

30. The combination of claim 29, further including a sleeve surrounding each leg within the second segment passes.

31. The combination of claim 15, wherein the holder includes two stages, a first stage having the cusp supports and a second stage having the commissure supports, the two stages being formed so as to be separable.

32. The combination of claim 31, wherein the first stage includes a central hub and a plurality of legs angling outward and downward to form the cusp supports at their terminal ends.

33. The combination of claim 31, wherein the second stage includes a flexible band around which the commissure supports are spaced, the band permitting the commissure supports to flex radially with respect to one another.

34. The combination of claim 31, wherein the second stage is attached separately to both the flexible heart valve and the first stage to permit the first stage to be separated from the valve while the second stage remains attached to the valve.

36. The method of claim 35, wherein the holder is attached to the heart valve at the time of assembly of the valve and the method includes packaging the holder with the valve.

37. The method of claim 36, wherein the holder includes a handle connector having a length permitting manual grasping that extends along the valve axis, the handle connector having a coupling for receiving a longer delivery handle.

38. The method of claim 35, wherein the step of attaching includes attaching free ends of a plurality of sutures to the holder and passing a middle segment of each suture through a portion of the valve.

39. The method of claim 38, the step of detaching includes severing the middle segment of each suture, wherein there is at least one cusp attachment suture attaching each cusp support to the valve, and wherein the cusp attachment sutures are routed to a common cut point on the holder.

15. A combined flexible heart valve and holder, comprising:

a prosthetic flexible heart valve having multiple leaflets joined together at a periphery of the valve at valve commissures that are generally axially aligned and evenly disposed about a valve axis, the valve commissures being configured for radial movement with respect to the valve axis and each being disposed between adjacent curvilinear valve cusps along the periphery of the valve, the valve leaflets coapting along the valve axis and curving in a direction to form an inflow side and an outflow side of the valve; and

a holder attached to the outflow side of the valve and having cusp supports that contact and axially support the valve cusps, the holder also having commissure supports between each two of the cusp supports that axially support the valve commissures yet permit radial their radial movement with respect to the valve axis.

35. A method of providing and implanting a flexible heart valve, including:

providing a prosthetic flexible heart valve having multiple leaflets joined together at a periphery of the valve at valve commissures that are generally axially aligned and evenly disposed about a valve axis, the valve commissures being configured for radial movement with respect to the valve axis and each being disposed between adjacent curvilinear valve cusps along the periphery of the valve, the valve leaflets coapting along the valve axis and curving in a direction to form an inflow side and an outflow side of the valve;

attaching a holder to the outflow side of the valve, the holder having cusp supports that contact and axially support the valve cusps and commissure supports between each two of the cusp supports that axially support the valve commissures yet permit radial their radial movement with respect to the valve axis;

delivering the combined flexible heart valve and holder to a site of valve implantation;

visualizing the site of valve implantation by flexing one of the valve commissures radially inward while being supported by the corresponding commissure support of the holder;

securing the flexible heart valve to the site of valve implantation; and

detaching the holder from the flexible heart valve.