Holder and deployment system for surgical heart valves

• US 10,307,249 B2
• Filed: 03/06/2017
• Issued: 06/04/2019
• Est. Priority Date: 04/30/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chang, Da-Yu, Fann, Hilda Z.
• Primary Examiner(s): Shi, Katherine M
• Application Number:
  US15/451,203
• Publication Number:
  US 20170172739A1
• Time in Patent Office: 820 Days
• Field of Search: 623 124, 623 126, 623 211, 623 218
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2210/00 Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

A holder for a hybrid heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The hybrid heart valve includes a non-expandable, non-compressible prosthetic valve and a self-expandable anchoring stent, thereby enabling attachment to the annulus without sutures. A first suture connects the holder to the valve and constricts an inflow end of the anchoring stent. A second suture connects the holder to the valve and extends down three holder legs to loop through fabric on the valve. Both sutures may loop over a single cutting well on the holder so that severing the first and second sutures at the single cutting well simultaneously releases the tension in the first suture, permitting the inflow end of the anchoring stent to expand, and disconnects the valve holder from the prosthetic heart valve.

Claims

1. A combination of a prosthetic heart valve for implant at a heart valve annulus and a holder therefor, comprising:

a prosthetic heart valve having a valve member with a non-expandable, non-collapsible annular support structure defining a flow orifice and an inflow end defining an inflow direction with an outflow direction opposite thereto, the valve member including valve leaflets attached to the support structure and mounted to alternately open and close across the flow orifice, and a self-expandable anchoring stent connected to the valve member at the inflow end of the support structure, the anchoring stent having an inflow end projecting in the inflow direction away from the support structure;

a valve holder having a central hub with structure adapted to mate with a delivery handle;

an upper connecting suture attaching the valve holder to the prosthetic heart valve at multiple locations; and

a lower connecting suture attached to the valve holder and extending around the inflow end of the anchoring stent in tension to constrict the inflow end from a relaxed size to a smaller size.

2. The combination of claim 1, wherein the anchoring stent has a fabric covering, and wherein the lower connecting suture passes through the fabric covering around the inflow end of the anchoring stent.

3. The combination of claim 1, wherein the lower connecting suture passes over a cutting well on the valve holder such that severing the lower connecting suture at the cutting well releases the tension therein and permits the inflow end of the anchoring stent to expand toward its relaxed size.

4. The combination of claim 1, wherein both the lower and upper connecting sutures pass over a single cutting well on the valve holder such that severing the lower and upper connecting sutures at the single cutting well simultaneously releases the tension in the lower connecting suture and disconnects the valve holder from the prosthetic heart valve.

5. The combination of claim 1, wherein the valve holder includes a plurality of legs that contact the valve member at the multiple locations having fabric incorporated into the valve member, and wherein the upper connecting suture passes circumferentially around the valve holder and threads through the fabric at the multiple locations.

6. The combination of claim 1, wherein the valve member support structure has three commissure posts projecting in the outflow direction and three cusps therebetween that arc in the inflow direction, and the valve leaflets are flexible and partly supported by the commissure posts of the support structure, wherein the valve holder includes the central hub and three legs that angle outward therefrom in the inflow direction to contact the valve member at the three cusps, and wherein the lower connecting suture is tied at two free ends to a terminal foot of one of the valve holder legs.

7. The combination of claim 1, wherein the valve member support structure has three commissure posts projecting in the outflow direction and three fabric-covered cusps therebetween that arc in the inflow direction, and the valve leaflets are flexible and partly supported by the commissure posts of the support structure, wherein the valve holder includes the central hub and three legs that angle outward therefrom in the inflow direction to contact the valve member at the three fabric-covered cusps, and wherein the upper connecting suture passes circumferentially around the valve holder and threads through the fabric at the three cusps.

8. The combination of claim 7, wherein the upper connecting suture is tied at first and second free ends to the valve holder, and in between passes circumferentially around the central hub of the valve holder and descends down each of the three legs to pass through two holes at a terminal foot thereof, the upper connecting suture being threaded through the fabric at each of the three cusps between the two holes, and wherein the upper connecting suture circles completely around each leg between the hub and the respective foot.

9. The combination of claim 1, wherein the anchoring stent has a series of crossed struts that define a regular array of diamond-shaped cells therebetween.

10. A combination of a prosthetic heart valve for implant at a heart valve annulus and a holder therefor, comprising:

a prosthetic heart valve having a valve member with a non-expandable, non-collapsible annular support structure defining a flow orifice and an inflow end defining an inflow direction with an outflow direction opposite thereto, the valve member including valve leaflets attached to the support structure and mounted to alternately open and close across the flow orifice, and a self-expandable anchoring stent projecting from the valve member at the inflow end of the support structure, the anchoring stent being convertible between an outwardly expanded, relaxed shape and an inwardly compressed delivery shape; and

a valve holder having a central hub with structure adapted to mate with a delivery handle, the valve holder defining a cutting well;

an upper connecting suture attaching the valve holder to the prosthetic heart valve at multiple locations and looped over the cutting well, wherein severing the upper connecting suture simultaneously detaches the valve holder from the prosthetic heart valve and converts the anchoring stent from its inwardly compressed delivery shape toward its outwardly expanded, relaxed shape.

11. The combination of claim 10, further including a lower connecting suture attached to the valve holder and extending around an inflow end of the anchoring stent in tension to constrict the inflow end from its outwardly expanded, relaxed shape to its inwardly compressed delivery shape, wherein severing the upper connecting suture also severs the lower connecting suture and releases the tension therein.

12. The combination of claim 11, wherein the anchoring stent has a fabric covering, and wherein the lower connecting suture passes through the fabric covering around the inflow end of the anchoring stent.

13. The combination of claim 11, wherein both the lower and upper connecting sutures pass over the cutting well on the valve holder such that severing the lower and upper connecting sutures at the cutting well simultaneously releases the tension in the lower connecting suture and disconnects the valve holder from the prosthetic heart valve.

14. The combination of claim 11, wherein the valve member support structure has three commissure posts projecting in the outflow direction and three cusps therebetween that arc in the inflow direction, and the valve leaflets are flexible and partly supported by the commissure posts of the support structure, wherein the valve holder includes the central hub and three legs that angle outward therefrom in the inflow direction to contact the valve member at the three cusps, and wherein the lower connecting suture is tied at two free ends to a terminal foot of one of the valve holder legs.

15. The combination of claim 11, wherein the lower connecting suture has a first free end attached to the valve holder, a middle portion that extends in a first length in the inflow direction, in a second length around the entire inflow end of the anchoring stent, and in a third length back to the valve holder alongside the first length, the lower connecting suture further having a fourth length that passes over the cutting well on the valve holder and ends in a second free end attached to the valve holder such that when the two free ends are attached to the valve holder the first suture is under tension and constricts the inflow end from its outwardly expanded, relaxed shape to its inwardly compressed delivery shape.

16. The combination of claim 10, wherein the valve holder includes a plurality of legs that contact the valve member at the multiple locations having fabric incorporated into the valve member, and wherein the upper connecting suture passes circumferentially around the valve holder and threads through the fabric at the multiple locations.

17. The combination of claim 10, wherein the valve member support structure has three commissure posts projecting in the outflow direction and three fabric-covered cusps therebetween that arc in the inflow direction, and the valve leaflets are flexible and partly supported by the commissure posts of the support structure, wherein the valve holder includes the central hub and three legs that angle outward therefrom in the inflow direction to contact the valve member at the three fabric-covered cusps, and wherein the upper connecting suture passes circumferentially around the valve holder and threads through the fabric at the three cusps.

18. The combination of claim 17, wherein the upper connecting suture is tied at first and second free ends to the valve holder, and in between passes circumferentially around the central hub of the valve holder and descends down each of the three legs to pass through two holes at a terminal foot thereof, the upper connecting suture being threaded through the fabric at each of the three cusps between the two holes, and wherein the upper connecting suture circles completely around each leg between the hub and the respective foot.

19. The combination of claim 10, wherein the anchoring stent has a series of crossed struts that define a regular array of diamond-shaped cells therebetween.

20. The combination of claim 10, wherein the anchoring stent has an outflow end connected to the valve member at the inflow end of the support structure and having a generally fixed dimension, and an inflow end projecting in the inflow direction away from the support structure that is constricted to a first diameter when the anchoring stent is in its inwardly compressed delivery shape and is expanded to a larger diameter when the anchoring stent is in its outwardly expanded, relaxed shape, the anchoring stent converting between two generally conical shapes.