PROSTHETIC HEART VALVE AND DELIVERY APPARATUS

• US 20160287386A1
• Filed: 06/13/2016
• Published: 10/06/2016
• Est. Priority Date: 08/22/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Alon, David, Benichou, Netanel, Meiri, Oded
• Granted Patent: US 10,238,487 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 using adhesives
• 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 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

Embodiments of the present disclosure provide a prosthetic heart valve and a heart valve delivery apparatus for delivery of the prosthetic heart valve to a native valve site via the human vasculature. The delivery apparatus is particularly suited for advancing a prosthetic valve through the aorta (i.e., in a retrograde approach) for replacing a diseased native aortic valve. In one embodiment, a self-expanding valve comprises an expandable stent that is shaped to maintain the valve in the aortic annulus against axial without anchors or retaining devices that engage the surrounding tissue. A delivery apparatus for delivering s self-expanding prosthetic valve can be configured to allow controlled and precise deployment of the valve from a valve sheath so as to minimize or prevent jumping of the valve from the valve sheath.

Claims

1. An assembly for implanting a prosthetic heart valve, comprising:

a collapsible and expandable prosthetic heart valve comprising an annular frame and a valve member having a plurality of flexible leaflets configured for allowing blood flow in only one direction, wherein the valve member is mounted within the frame; and

a delivery apparatus comprising;

a handle portion;

at least one suture member;

a first shaft having a first end portion and a second end portion, wherein the first end portion of the first shaft is coupled to the handle portion, and the suture member is coupled to and extends from the second end portion and forms a loop; and

a second shaft having a first end portion and a second end portion, wherein the second shaft extends through the first shaft, the first end portion of the second shaft is movably coupled to the handle, and the second end portion of the second shaft is disposed adjacent the second end portion of the first shaft,

wherein the suture member extends through an end portion of the frame, the second end portion of the second shaft extends through the loop of the suture member to releasably secure the suture member relative to the prosthetic heart valve, and the second shaft is axially movable to remove the second end portion of the second shaft from the loop, thereby releasing the suture member from the prosthetic heart valve.

2. The assembly of claim 1, wherein the delivery apparatus further comprises:

a suture retention member coupled to and extending from the second end portion of the first shaft and to which the suture member is secured; and

a distal member disposed axially distal and spaced relative to the suture retention member,

wherein the second shaft is axially movable from a first position to a second position, wherein the second shaft extends through the suture retention member, extends through the loop in the suture member, and extends through the distal member when the second shaft is in the first position, and wherein the second shaft is withdrawn from the distal member and the loop in the suture member when the second shaft is in the second position.

3. The assembly of claim 2, wherein the second shaft extends through the loop in the suture member at a location distal to the suture retention member and proximal to the distal member.

4. The assembly of claim 1, wherein the first shaft of the delivery apparatus is a valve catheter shaft, and the second shaft of the delivery apparatus is a release wire.

5. The assembly of claim 1, wherein the frame of the prosthetic heart valve comprises an aperture formed in the end portion, and the suture member extends through the aperture of the frame.

6. The assembly of claim 1, wherein the frame of the prosthetic heart valve comprises a plurality of apertures formed in the end portion, and the suture member comprises a plurality of suture members, and wherein the suture members extend through respective apertures of the frame.

7. The assembly of claim 1, wherein the suture member includes a plurality of suture members extending through the end portion of the frame, the second shaft comprises a plurality of release wires configured to releasably couple respective ones of the suture members to the prosthetic heart valve.

8. The assembly of claim 7, wherein the release wires of the second shaft are connected together such that the release wires are simultaneously moveable relative to the sutures of the first shaft.

9. The assembly of claim 7, wherein the release wires of the second shaft are independently movable relative to each other and the suture members of the first shaft.

10. The assembly of claim 1, wherein the delivery apparatus further comprises a sheath portion and a plurality of flexible flaps configured to extend over and radially collapse the end portion of the prosthetic heart valve from an expanded configuration to a compressed configuration such that the prosthetic heart valve is retractable into the sheath portion of the delivery apparatus.

11. The assembly of claim 10, wherein the flaps are configured to at least partially circumferentially overlap each other in a first configuration and to expand radially outwardly relative to each other from the first configuration to a second configuration.

12. The assembly of claim 10, wherein the flaps are configured to engage apices of the end portion of the prosthetic heart valve.

13. The assembly of claim 10, wherein the flaps are self-expandable.

14. The assembly of claim 10, wherein the flaps are mechanically expandable.

15. A delivery apparatus for a prosthetic heart valve, comprising:

a handle portion;

a shaft having first and second end portions;

a suture retention member;

a plurality of sutures, wherein the first end portion of the shaft is coupled to the handle portion, the suture retention member is coupled to and extends from the second end portion of the shaft, and the sutures are secured to and extend from the suture retention member; and

a suture release member having first and second end portions, wherein the suture release member extends through the shaft, the first end portion of the suture release member is coupled to and movable relative to the handle, and the second end portion of the suture release member is disposed adjacent the second end portion of the shaft and configured to selectively engage the sutures,

wherein the sutures are configured to extend through a frame of a prosthetic heart valve to releasably couple the prosthetic heart valve to the shaft when the sutures are engaged by the suture release member, and

wherein the suture release member is movable from a first position in which the suture release member engages the sutures to a second position in which the suture release member is disengaged from the sutures to allow the prosthetic heart valve to de-couple from the shaft.

16. The delivery apparatus of claim 15, wherein the suture release member extends through the suture retention member and loops in the sutures in the first position and is withdrawn from the loops in the sutures in the second position.

17. The delivery apparatus of claim 15, wherein the suture release member comprises a plurality of release wires, and each of the release wires is configured to selectively engage a respective suture and is movable from a respective first position to a respective second position.

18. The delivery apparatus of claim 17, wherein the release wires are independently movable from a respective first position to a respective second position relative to each other.

19. The delivery apparatus of claim 18, wherein the release wires are movable from respective first positions to respective second positions in unison.

20. The delivery apparatus of claim 16, further comprising a distal member axially spaced from the suture retention member, wherein the suture release member extends through the distal member in the first position and is withdrawn from the distal member in the second position.

21. The delivery apparatus of claim 20, wherein the suture release member extends through the loops at a location distal to the suture retention member and proximal to the distal member.

22. The delivery apparatus of claim 15, further comprising a plurality of flexibly flaps and a sheath portion, wherein the flaps are configured to radially collapse the prosthetic heart valve from an expanded configuration to a compressed configuration such that the prosthetic heart valve is retractable into the sheath portion.