Unitary quick-connect prosthetic heart valve deployment system

• US 9,005,277 B2
• Filed: 12/21/2012
• Issued: 04/14/2015
• 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 Zenyo, Yambao, August R., Campbell, Louis A., Huntley, Tammy, Zeng, Qinggang, Cristea, Carey L., Kalam, Faisal
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US13/723,799
• Publication Number:
  US 20130116777A1
• Time in Patent Office: 844 Days
• Field of Search: 623/2.11, 623/1.11, 623/1.24, 623/1.26
• 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 frame defining an orifice along a valve axis and leaflets that provide occluding surfaces across the orifice, the heart valve further including a plastically-expandable coupling stent having a first end connected to a sewing ring on an inflow end of the prosthetic valve, the coupling stent having a contracted state for delivery to an implant position and an expanded state;

a valve holder subassembly attached to the heart valve opposite the coupling stent and extending through an opening defined by the leaflets and defining a central lumen coincident with the valve axis;

a catheter having a distal expander; and

a handle configured to attach to a proximal end of the valve holder subassembly and having a lumen for passage of the catheter, the distal expander in a contracted configuration being sized to extend distally through the handle lumen, through the holder subassembly lumen and through the heart valve to a position within the coupling stent for expansion of a second end thereof.

2. The system of claim 1, wherein the contracted state of the coupling stent is generally conical, tapering inward from the first end toward the second end.

3. The system of claim 2, wherein in the expanded state the coupling stent is generally conical, tapering outward from the first end toward the second end.

4. The system of claim 1, wherein the coupling stent includes a reinforcing ring on the first end continuously sewn to the sewing ring and a plurality of interconnected expandable struts extending therefrom that are deformed by the distal expander from the contracted state to the expanded state.

5. The system of claim 4, 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.

6. The system of claim 1, wherein a distal end of the handle couples with a snap-fit connection to a central hub of the holder subassembly to enable manipulation of the heart valve.

7. The system of claim 1, wherein the leaflets are flexible and come together in an outflow direction to occlude the orifice, the system further holder subassembly including a sleeve having a throughbore threaded to a valve holder to extend from an outflow to an inflow side of the leaflets.

8. The system of claim 7, wherein the heart valve mounted on the valve holder is packaged separately from the handle and the catheter.

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

a heart valve including a prosthetic valve defined by a support structure defining an orifice along a valve axis with an undulating shape of alternative cusps and commissures projecting in an outflow direction that supports flexible leaflets that come together in an outflow direction to occlude the orifice, the heart valve further including a balloon-expandable coupling stent having a first end attached to an inflow end thereof opposite the commissures and a second end projecting away therefrom, the coupling stent having a contracted state for delivery to an implant position and an expanded state;

a handle system connected to an outflow side 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, in a contracted configuration, is sized to pass distally through the throughbore of the handle system and distally past without contacting the heart valve leaflets such that the balloon is positioned to expand the coupling stent.

10. The system of claim 9, wherein the contracted state of the coupling stent is generally conical, tapering inward from the first end toward the second end.

11. The system of claim 10, wherein in the expanded state the coupling stent is generally conical, tapering outward from the first end toward the second end.

12. The system of claim 9, wherein the handle system comprises a valve holder connected to 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.

13. The system of claim 12, wherein the sleeve is threaded to the valve holder.

14. The system of claim 12, wherein the handle attaches to a proximal end of the valve holder with a snap-fit coupling.

15. The system of claim 9, wherein the prosthetic valve includes a sewing ring on the inflow end thereof, and the coupling stent is continuously sewn to the sewing ring.

16. The system of claim 15, wherein the coupling stent includes a reinforcing ring on the first 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.

17. The system of claim 16, 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.

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

a heart valve including a prosthetic valve having a support structure defining an orifice along a valve axis and flexible leaflets that provide occluding surfaces across the orifice, the heart valve further including a plastically-expandable coupling stent having a first end attached to an inflow end thereof and a second end projecting away therefrom, the coupling stent having a contracted state for delivery to an implant position and an expanded state;

a valve holder connected to the heart valve on the side opposite to the coupling stent;

a tubular sleeve having a throughbore connected to the valve holder and extending therefrom through an opening defined by the flexible leaflets; and

a balloon catheter having a balloon that, in a contracted configuration, is sized to pass distally through the valve holder and sleeve and thus through the heart valve leaflets such that the balloon is positioned to expand the coupling stent.

19. The system of claim 18, wherein the contracted state of the coupling stent is generally conical, tapering inward from the first end toward the second end.

20. The system of claim 19, wherein in the expanded state the coupling stent is generally conical, tapering outward from the first end toward the second end.

21. The system of claim 18, wherein the sleeve is threaded to the valve holder.

22. The system of claim 18, wherein the delivery handle mates with the proximal end of the valve holder with a snap-fit coupling.

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

24. The system of claim 23, wherein the coupling stent includes a reinforcing ring on the first 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.

25. The system of claim 24, 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.