ERGONOMIC MITRAL HEART VALVE HOLDERS

• US 20120136434A1
• Filed: 11/29/2011
• Published: 05/31/2012
• Est. Priority Date: 11/30/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Carpentier, Alain F., Murad, Michael C.
• Granted Patent: US 9,078,750 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2230/0071 spherical

Abstract

A holder for a prosthetic mitral heart valve that attaches to an inflow end of the valve and includes a simple tensioning mechanism that flexes the heart valve commissure posts inward to help prevent suture looping. The tensioning mechanism may include relatively movable rings of the holder or a generally unitary holder with a tensor, or rotatable knob. Connecting sutures thread through internal passages in the holder and travel in the outflow direction along valve commissure posts, emerging at the post tips and mutually crossing over the outflow side of the valve. A handle attaches off-center on the holder to increase visualization of and access to the heart valve through a central window. The holder is constructed of non-metallic materials so as to avoid interfering with imaging devices, and the handle is ergonomically curved and shaped to facilitate manipulation. The holder may be shaped as a ring with an open inner diameter for enhanced access to the commissure posts and leaflets.

Claims

1. A combination including a holder for handling and delivering a prosthetic mitral heart valve to an implantation site, comprising:

a prosthetic mitral heart valve having an inflow end and three flexible commissures ending in tips projecting in an outflow direction;

a holder body contacting the inflow end of the heart valve, the holder body defining a central window through which leaflets of the valve are visible and having internal peripheral passages;

three connecting sutures each fixed to the holder body and having a loop extending through the internal peripheral passages, out of the holder body and along each of the commissure posts of the valve, the three closed ends of the loops of the connecting sutures mutually crossing over between the tips of the commissure posts; and

a tensioning mechanism on the holder for applying tension to the connecting sutures to cause the commissure post tips to move radially inward.

2. The combination of claim 1, wherein the tensioning mechanism on the holder comprises a rotatable tensor operable from an inflow side of the holder and connected to a spool around which is wrapped each of the connecting sutures so that rotation of the tensor applies tension to the connecting sutures.

3. The combination of claim 2, wherein the holder further includes a handle extending from the holder body and the tensor comprises a separate element adjacent the handle.

4. The combination of claim 2, wherein the holder further includes a handle extending from the holder body and the tensor comprises the handle which is rotatable relative to the holder body.

5. The combination of claim 1, wherein the holder body has relatively rotatable rings, and each connecting suture has two free ends attached to different rotatable rings and the loop, wherein relative rotation of the rings applies tension to the connecting sutures.

6. The combination of claim 5, wherein the relatively rotatable rings have engaging ratchet teeth to permit relative rotation in one direction only, and a pair of stops that engage to limit total relative rotation.

7. A combination including a holder for handling and delivering a prosthetic mitral heart valve to an implantation site, comprising:

a prosthetic mitral heart valve having an inflow end and three flexible commissures ending in tips projecting in an outflow direction;

a holder body contacting the inflow end of the heart valve, the holder body defining a central window through which leaflets of the valve are visible;

connecting sutures each fixed to the holder body and extending from the holder body along each of the commissure posts of the valve, the connecting sutures crossing between the tips of the commissure posts;

a tensioning mechanism on the holder for applying tension to the connecting sutures to cause the commissure post tips to move radially inward; and

a handle attached adjacent a peripheral edge of the holder and angling radially outward therefrom.

8. The combination of claim 7, wherein the tensioning mechanism on the holder comprises a rotatable tensor operable from an inflow side of the holder and connected to a spool around which is wrapped each of the connecting sutures so that rotation of the tensor applies tension to the connecting sutures.

9. The combination of claim 8, wherein the tensor comprises a separate element adjacent the handle.

10. The combination of claim 8, wherein the tensor comprises the handle which is rotatable relative to the holder body.

11. The combination of claim 7, wherein the holder body has relatively rotatable rings, and each connecting suture has two free ends attached to different rotatable rings and a loop that extends from the holder body through the valve and across the tips of the commissure posts, wherein relative rotation of the rings applies tension to the connecting sutures.

12. The combination of claim 11, wherein the relatively rotatable rings have engaging ratchet teeth to permit relative rotation in one direction only, and a pair of stops that engage to limit total relative rotation.

13. The combination of claim 7, wherein the handle angles outward in an S-shape.

14. The combination of claim 7, wherein the handle has a first portion that angles outward initially between 5°

-20° and

has a second portion angled outward between about 20°

-60°

.

15. A combination including a holder for handling and delivering a prosthetic mitral heart valve to an implantation site, comprising:

a prosthetic mitral heart valve having an inflow end and three flexible commissures ending in tips projecting in an outflow direction, the heart valve defining a flow orifice having a nominal size in millimeters corresponding to a labeled size;

a holder body contacting the inflow end of the heart valve, the holder body defining a large central window through which leaflets of the valve are visible, the central window having a diameter approximately the same as the valve size;

connecting sutures each fixed to the holder body and connecting the valve to the holder; and

a handle attached adjacent a peripheral edge of the holder and angling radially outward therefrom.

16. The combination of claim 15, further including a tensioning mechanism on the holder for applying tension to the connecting sutures to cause the commissure post tips to move radially inward, the tensioning mechanism comprising a rotatable tensor operable from an inflow side of the holder and connected to a spool around which is wrapped each of the connecting sutures so that rotation of the tensor applies tension to the connecting sutures.

17. The combination of claim 16, wherein the tensor comprises a separate element adjacent the handle.

18. The combination of claim 16, wherein the tensor comprises the handle which is rotatable relative to the holder body.

19. The combination of claim 15, further including a tensioning mechanism on the holder for applying tension to the connecting sutures to cause the commissure post tips to move radially inward, wherein the holder body has relatively rotatable rings, and each connecting suture has two free ends attached to different rotatable rings and a loop therebetween that passes through the valve and across the commissure post tips, wherein relative rotation of the rings applies tension to the connecting sutures.

20. The combination of claim 15, wherein the handle angles outward in an S-shape, and has a first portion that angles outward initially between 5°

-20° and

has a second portion angled outward between about 20°

-60°

.