Holder and deployment system for surgical heart valves

• US 9,585,752 B2
• Filed: 04/29/2015
• Issued: 03/07/2017
• 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:
  US14/700,007
• Publication Number:
  US 20150313711A1
• Time in Patent Office: 678 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.11, 623/2.18
• US Class Current: 1/1
• 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 having a first end extending around the flow orifice and connected to the valve member at the inflow end of the support structure so that the first end maintains a fixed diameter, the anchoring stent having a second end projecting in the inflow direction away from the support structure and having a relaxed, expanded shape defining a first peripheral size; and

a valve holder connected by a first suture to the prosthetic heart valve, wherein the first suture extends around the second end of the anchoring stent and is placed under tension to constrict the second end to a second peripheral size smaller than the first peripheral size.

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

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

4. The combination of claim 1, wherein the valve holder is further connected by a second suture to the prosthetic heart valve, the valve holder including a plurality of legs that contact the valve member at the same number of locations having fabric incorporated into the valve member, and wherein the second suture passes circumferentially around the valve holder and threads through the fabric at the locations.

5. The combination of claim 4, wherein both the first and second sutures pass over a single cutting well on the valve holder such that severing the first and second sutures at the single cutting well simultaneously releases the tension in the first suture, permitting the second end of the anchoring stent to expand toward its first peripheral size, and disconnects the valve holder from the prosthetic heart valve.

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 holder includes a central hub and three legs that angle outward and in the inflow direction to contact the valve member at the three cusps, and wherein the first suture is tied at two free ends to a terminal foot of one of the 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 holder includes a central hub and three legs that angle outward and in the inflow direction to contact the valve member at the three fabric-covered cusps, and wherein the valve holder is further connected by a second suture to the prosthetic heart valve that passes circumferentially around the valve holder and threads through the fabric at the three cusps.

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

9. 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; and

a valve holder connected by a first suture to the prosthetic heart valve, wherein the first 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 first suture further having a fourth length that passes over a 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 a relaxed size to a smaller size.

10. The combination of claim 9, wherein the anchoring stent has a fabric covering, and wherein the first suture passes through the fabric covering around the second end of the anchoring stent.

11. The combination of claim 9, wherein the valve holder is further connected by a second suture to the prosthetic heart valve, the valve holder including a plurality of legs that contact the valve member at the same number of locations having fabric incorporated into the valve member, and wherein the second suture passes circumferentially around the valve holder and threads through the fabric at the locations.

12. The combination of claim 11, wherein both the first and second sutures pass over the cutting well on the valve holder such that severing the first and second sutures at the cutting well simultaneously releases the tension in the first suture, permitting the second end of the anchoring stent to expand toward its first peripheral size, and disconnects the valve holder from the prosthetic heart valve.

13. The combination of claim 9, 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 holder includes a central hub and three legs that angle outward and in the inflow direction to contact the valve member at the three cusps, and wherein the first suture is tied at two free ends to a terminal foot of one of the holder legs.

14. The combination of claim 9, 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 holder includes a central hub and three legs that angle outward and in the inflow direction to contact the valve member at the three fabric-covered cusps, and wherein the valve holder is further connected by a second suture to the prosthetic heart valve that passes circumferentially around the valve holder and threads through the fabric at the three cusps.

15. The combination of claim 14, wherein the second suture is tied at first and second free ends to the holder, and in between passes circumferentially around the hub of the holder and descends down each of the three legs to pass through two holes at a terminal foot thereof, the second suture being threaded through the fabric at each of the three cusps between the two holes, and wherein the second suture circles completely around each leg between the hub and the respective foot.

16. A method of deploying a prosthetic heart valve for implant at a heart valve annulus, comprising:

providing a prosthetic heart valve having a valve member with a non-expandable, non-collapsible annular support structure and valve leaflets mounted thereto to alternately open and close, and a self-expandable anchoring stent connected to the valve member at an inflow end of the support structure, the anchoring stent having an inflow end projecting in the inflow direction away from the support structure, the prosthetic heart valve being secured to a valve holder by a first suture that attaches at two free ends to the valve holder and extends around the entire inflow end of the anchoring stent under tension and constricts the inflow end from a relaxed size to a smaller size, the first suture having a middle portion that passes over a cutting well on the valve holder;

advancing the prosthetic heart valve to the heart valve annulus; and

severing the first suture at the cutting well to release the tension therein and permit the inflow end of the anchoring stent to expand toward its relaxed size.

17. The method of claim 16, further including a second suture connecting the prosthetic heart valve to the holder, wherein both the first and second sutures pass over the cutting well on the valve holder such that severing the first and second sutures at the cutting well simultaneously releases the tension in the first suture, permitting the inflow end of the anchoring stent to expand toward its first peripheral size, and disconnects the valve holder from the prosthetic heart valve.

18. The method of claim 17, wherein the valve holder includes a central hub and a plurality of legs that contact the valve member at the same number of locations having fabric incorporated into the valve member, and wherein the second suture passes circumferentially around the valve holder and threads through the fabric at the locations.

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