Unitary quick connect prosthetic heart valve and deployment system and methods

• US 8,348,998 B2
• Filed: 06/23/2010
• Issued: 01/08/2013
• Est. Priority Date: 06/26/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Pintor, Rafael, Chau, Mark, Oba, Travis, Yambao, August, Campbell, Louis A., Huntley, Tammy, Zeng, Qinggang, Cristea, Carey, Kalam, Faisal
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US12/821,628
• Publication Number:
  US 20100331972A1
• Time in Patent Office: 930 Days
• Field of Search: None
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2250/006 modular

Abstract

A quick-connect heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable coupling stent, thereby enabling attachment to the annulus without sutures. A small number of guide sutures may be provided for aortic valve orientation. The prosthetic valve may be a commercially available valve with a sewing ring with the coupling stent attached thereto. The coupling stent may expand from a conical deployment shape to a conical expanded shape, and may include web-like struts connected between axially-extending posts. A system and method for deployment includes a hollow two-piece handle through which a balloon catheter passes. A valve holder is stored with the heart valve and the handle easily attaches thereto to improve valve preparation steps.

Claims

1. A system for delivering a prosthetic heart valve, comprising:

a heart valve including a prosthetic valve having a non-expandable, non-collapsible orifice defined by a support structure with an undulating shape of alternative commissures and cusps in an outflow direction that supports flexible leaflets that come together within the orifice in an outflow direction, the heart valve further including an expandable coupling stent extending from an inflow end thereof, the coupling stent having a contracted state for delivery to an implant position and an expanded state;

a valve holder connected to an outflow end of the heart valve and having a sleeve extending between the flexible leaflets, the holder and sleeve together defining a throughbore from an outflow side of the leaflets to an inflow side;

a balloon catheter having a balloon; and

a handle configured to attach to a proximal end of the valve holder and having a lumen for passage of the balloon catheter, the lumen aligned with the throughbore of the valve holder and sleeve, the balloon extending distally through the handle lumen and the throughbore and distally between the heart valve leaflets without contacting the leaflets such that the balloon is positioned to expand the coupling stent.

2. The system of claim 1, wherein the prosthetic valve includes a sewing ring on the inflow end thereof, and wherein the coupling stent attaches to the sewing ring.

3. The system of claim 2, wherein the coupling stent includes a reinforcing ring on an outflow end continuously sewn to the sewing ring and a plurality of interconnected expandable struts extending therefrom that are deformed by the balloon from the contracted state to the expanded state.

4. The system of claim 3, wherein the reinforcing ring follows an undulating path with peaks and troughs that generally corresponds to an undulating contour of an underside of the sewing ring.

5. The system of claim 1, wherein the contracted state of the coupling stent is conical, tapering down in a distal direction.

6. The system of claim 1, wherein the handle comprises a proximal section and a distal section that may be coupled together in series to form a continuous lumen, and wherein the distal section is adapted to couple to a central hub of the holder to enable manual manipulation of the heart valve using the distal section prior to connection with the proximal handle section.

7. The system of claim 6, wherein the balloon catheter and proximal handle section are packaged together with the balloon within the proximal section lumen.

8. The system of claim 1, wherein the heart valve mounted on the holder is packaged separately from the handle and the balloon catheter.

9. The system of claim 1, wherein the sleeve comprises a separate element threaded to the valve holder.

10. The system of claim 9, wherein the heart valve mounted on the holder is packaged separately from the sleeve.

11. The system of claim 1, wherein the handle attaches to a proximal end of the valve holder with a snap-fit coupling.

12. A system for delivering a prosthetic heart valve, comprising:

a heart valve including a prosthetic valve defined by a support structure with an undulating shape of alternative commissures and cusps in an outflow direction that supports flexible leaflets that come together within a flow orifice in the outflow direction, the heart valve further including a balloon-expandable coupling stent attached to and extending from an inflow end thereof, the coupling stent having a contracted state for delivery to an implant position and an expanded state;

a valve holder and handle system connected to an outflow end of the heart valve and having a throughbore that extends from an outflow side to an inflow side of the leaflets; and

a balloon catheter having a balloon that passes distally through the throughbore of the valve holder and handle system and distally past without contacting the heart valve leaflets such that the balloon is positioned to expand the coupling stent.

13. The system of claim 12, wherein the contracted state of the coupling stent is conical, tapering down in a distal direction.

14. The system of claim 12, wherein the valve holder and handle system comprises a valve holder connected to the outflow end of the heart valve, a sleeve that connects to the valve holder and extends between the flexible leaflets, and a handle configured to attach to a proximal end of the valve holder and having a lumen for passage of the balloon catheter.

15. The system of claim 14, wherein the sleeve is threaded to the valve holder.

16. The system of claim 14, wherein the heart valve mounted on the holder is packaged separately from the sleeve.

17. The system of claim 14, wherein the handle attaches to a proximal end of the valve holder with a snap-fit coupling.

18. The system of claim 12, wherein the prosthetic valve includes a sewing ring on the inflow end thereof, and the coupling stent is continuously sewn to the sewing ring.

19. The system of claim 18, wherein the coupling stent includes a reinforcing ring on an outflow end sewn to the sewing ring and a plurality of interconnected expandable struts extending therefrom that are deformed by the balloon from the contracted state to the expanded state.

20. The system of claim 19, wherein the reinforcing ring follows an undulating path with peaks and troughs that generally corresponds to an undulating contour of an underside of the sewing ring.

21. A system for delivering a prosthetic heart valve, comprising:

a heart valve including a prosthetic valve having a support structure that supports flexible leaflets that coapt in an outflow direction to provide a one-way valve, the heart valve further including a balloon-expandable coupling stent attached to and extending from an inflow end thereof, the coupling stent having a contracted state for delivery to an implant position and an expanded state;

a valve holder connected to an outflow end of the heart valve;

a sleeve connected to the valve holder and extending distally therefrom within the flexible leaflets, the sleeve having a throughbore; and

a balloon catheter mounted to slide within a lumen of a delivery handle that mates with a proximal end of the valve holder such that a user can advance a balloon on the balloon catheter distally through the valve holder and sleeve past the heart valve leaflets such that the balloon is positioned to expand the coupling stent.

22. The system of claim 21, wherein the contracted state of the coupling stent is conical, tapering down in a distal direction.

23. The system of claim 21, wherein the sleeve is threaded to the valve holder.

24. The system of claim 21, wherein the heart valve connected with the holder is packaged separately from the sleeve.

25. The system of claim 21, wherein the delivery handle mates with the proximal end of the valve holder with a snap-fit coupling.

26. The system of claim 21, wherein the prosthetic valve includes a sewing ring on the inflow end thereof, and the coupling stent is continuously sewn to the sewing ring.

27. The system of claim 26, wherein the coupling stent includes a reinforcing ring on an outflow end sewn to the sewing ring and a plurality of interconnected expandable struts extending therefrom that are deformed by the balloon from the contracted state to the expanded state.

28. The system of claim 27, wherein the reinforcing ring follows an undulating path with peaks and troughs that generally corresponds to an undulating contour of an underside of the sewing ring.