Heart valve holder for constricting the valve commissures and methods of use

• US 20020013621A1
• Filed: 12/21/2000
• Published: 01/31/2002
• Est. Priority Date: 07/27/2000
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Stobie, Robert, Ekholm, C. Roger, Newborg, Steve, Jackman, Jerry L., Ton-That, Cuong
• Granted Patent: US 6,409,758 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

An improved holder, system and method for implanting a tissue-type prosthetic heart mitral valve that constricts the commissure posts of the valve and allows the user to detach the handle of the holder prior to withdrawing the holder itself. The ability to remove the handle allows a surgeon greater access to suturing the prosthetic valve to the mitral annulus. The holder may include two relatively movable plates, one of which attaches to the valve sewing on the inflow end of the valve ring and the other which attaches via sutures to the valve commissures on the outflow end. Separation of the plates places the sutures in tension and constricts the commissures. An adjusting member or adapter is interposed between the handle and holder to enable separation of the two plates and removal of the handle. The adjusting member or adapter may be packaged with the valve and holder combination, or may be sold as a separate unit, possibly with the handle, so that prior art holders can be retrofit.

Claims

1. A holder for a tissue-type prosthetic mitral heart valve attachable to a surgical delivery handle, the heart valve having an inflow end and an outflow end and a flow axis therebetween, the valve including an annular suture ring at the inflow end and radially flexible commissure posts circumferentially-spaced around the outflow end that support occluding tissue surfaces of the valve, comprising:

a commissure post constriction mechanism releasably attached to the sewing ring at the inflow end of the valve, the mechanism adapted to constrict the valve commissure posts radially inward from a relaxed position to a constricted position when actuated by the delivery handle, and

a retaining mechanism that retains the commissure post constriction mechanism in the constricted position after the delivery handle is removed.

2. The holder of claim 1 wherein the commissure post constriction mechanism comprises:

a valve abutment portion sized and shaped to abut the inflow end of the valve;

an adjusting portion coupled to the abutment portion opposite the valve and able to move with respect to the abutment portion; and

one or more filaments attached to the adjusting portion and coupled to the commissure posts that constrict the commissure posts radially inwardly upon movement of the adjusting portion with respect to the abutment portion.

3. The holder of claim 2 wherein the commissure post constriction mechanism further comprises:

an adjusting member coupled to the adjusting portion and adapted to move the adjusting portion with respect to the abutment portion.

4. The holder of claim 3 wherein the adjusting member is externally threaded, the adjusting portion including a threaded aperture for receiving the external threads of the adjusting member and being open to the abutment portion, such that upon advancement into the threaded aperture the threaded adjusting member contacts the abutment portion and forces the adjusting portion away from the abutment portion.

5. The holder of claim 4 wherein the valve abutment portion has a generally planar shape, and the adjusting portion has a substantially complementary planar shape to the valve abutment portion with the threaded aperture extending through an upstanding boss in the center thereof.

6. The holder of claim 4 wherein the adjusting member has a central longitudinal threaded bore sized to receive the threaded end of the handle.

7. The holder of claim 6 wherein the adjusting member and the threaded aperture in the adjusting portion cooperate to form the retaining mechanism wherein the frictional resistance to rotation therebetween is greater than the frictional resistance to rotation between the threaded end of the handle and the threaded bore of the adjusting member.

8. The holder of claim 7 wherein the adjusting member and the threaded aperture in the adjusting portion are each made of a polymer, and the threaded end of the handle is metal.

9. The holder of claim 4 wherein the adjusting member and the adjusting portion include interfering structures that engage upon advancement of the adjusting member into the threaded aperture of the adjusting portion to prevent reversal of the adjusting member therefrom.

10. The holder of claim 2 wherein the commissure post constriction comprises a ratchet assembly that maintains a space between the valve abutment portion and the adjusting portion and holds the commissure posts in the constricted position after the handle is detached.

11. The holder of claim 10 wherein the ratchet assembly comprises one or more ratchet members affixed to the valve abutment portion that each engage a complementary opening in the adjusting portion.

12. The holder of claim 2 wherein the commissure post constriction comprises an upstanding leg on the valve abutment portion that maintains a space between the valve abutment portion and the adjusting portion and holds the commissure posts in the constricted position after the handle is detached.

13. A method for retrofitting a holder for a tissue-type prosthetic mitral heart valve attachable to a surgical delivery handle, the heart valve having an inflow end and an outflow end and a flow axis therebetween, the valve including an annular suture ring at the inflow end and radially flexible commissure posts circumferentially-spaced around the outflow end that support occluding tissue surfaces of the valve, the holder having a commissure post constriction mechanism releasably attached to the sewing ring at the inflow end of the valve, the mechanism adapted to constrict the valve commissure posts radially inward from a relaxed position to a constricted position when actuated by the delivery handle, the method including:

providing a retaining mechanism that retains the commissure post constriction mechanism in the constricted position after the delivery handle is removed.

14. The method of claim 13 wherein the step of providing includes providing the retaining mechanism during the holder assembly process so that the retaining mechanism is attached to and shipped as a unit with the prosthetic valve.

15. The method of claim 13 wherein the step of providing includes providing the retaining mechanism separately from the holder and valve combination and the method includes coupling the retaining mechanism to the holder at the time of surgical implantation of the valve.

16. The method of claim 15 including packaging and selling the retaining mechanism and delivery handle as a unit.

17. The method of claim 13 wherein the retaining mechanism comprises an adapter that is interposed between and threadingly engaged to the holder and the handle.

18. A kit of storage and handling clips and heart valve holders for different diameter tissue-type prosthetic mitral heart valves, the heart valves each having an inflow end and an outflow end and a flow axis therebetween, each valve including an annular suture ring at the inflow end and radially flexible commissure posts circumferentially-spaced around the outflow end that support occluding tissue surfaces of the valve, the kit comprising:

a set of holders each adapted to attach to the sewing ring at the inflow end of a valve and having a generally planar portion including a plurality of tangs radiating from a central body to cover a portion of the suture ring, the tangs being radially dimensioned to correspond to the diameter of the sewing ring; and

each holder including a plurality of peripheral notches in the planar portion; and

a plurality of identical storage and handling clips each having a plurality of fingers for engaging the peripheral notches in any one of the holders.

19. The kit of claim 18, wherein the planar portion of each holder is generally triangular in shape with the tangs at the apices, and a peripheral notch located adjacent each tang.

20. The kit of claim 18, wherein each clip comprises a disk portion and a handle pivotally attached to one side thereof, with the fingers extending generally axially from the other side thereof.

21. The kit of claim 20, wherein there are three fingers in each clip evenly disposed about the axis of the disk portion.

22. A method for replacing a heart valve, comprising the steps of:

providing a prosthetic tissue-type heart valve having an inflow end and an outflow end and a flow axis therebetween and including a suture ring affixed to a stent having commissure posts circumferentially-spaced about the flow axis for supporting occluding surfaces of the valve, the commissure posts being cantilevered generally in the outflow direction;

affixing a holder to the inflow end of the valve;

attaching a handle to the holder and simultaneously constricting the commissure posts of the valve;

inserting the valve to the target annulus of the native heart valve using the handle;

removing the handle while maintaining the commissure posts constricted;

securing the valve to the annulus; and

detaching the holder from the valve.

23. The method of claim 22, wherein the holder comprises:

a valve abutment portion sized and shaped to abut the inflow end of the valve;

an adjusting portion coupled to the abutment portion opposite the valve and able to move with respect to the abutment portion; and

one or more filaments attached to the adjusting portion and coupled to the commissure posts that constrict the commissure posts radially inwardly upon movement of the adjusting portion with respect to the abutment portion,

the method including moving the adjusting portion away from the abutment portion when attaching the handle to the holder so that the filaments are pulled by the adjusting portion to cause the commissure posts to constrict radially inward.

24. The method of claim 23 wherein the holder further includes an adjusting member coupled to both the abutment portion and the adjusting portion and adapted to transfer movement of the handle to cause the adjusting portion to move with respect to the abutment portion.

25. The method of claim 24, wherein the handle includes threads that engage complementary threads on the adjusting member, and the adjusting member includes threads that engage complementary threads on the adjusting portion, wherein the frictional resistance to rotation between the adjusting member and adjusting portion is greater than the frictional resistance to rotation between the handle and the adjusting member, the method including:

fully seating the handle into the adjustment member and advancing the handle and adjustment member further to cause the adjusting portion to move with respect to the abutment portion; and

reversing rotation of the handle to decouple the handle from the adjustment member without reversing the adjustment member from engagement with the adjusting portion.

26. The method of claim 23 wherein the abutment portion includes a ratchet member that engages a complementary opening in the adjusting portion to retain the valve in the constricted position after the handle is removed, the method including ratcheting the valve abutment portion and the adjusting portion apart.

27. The method of claim 23 wherein the abutment portion includes an upstanding leg having a hook that couples the valve abutment portion and the adjusting portion together and a stop member that maintains a space between the valve abutment portion and the adjusting portion to hold the commissure posts in the constricted position after the handle is removed, the method including displacing the valve abutment portion and the adjusting portion apart until the stop member engages the adjusting portion.