Prosthetic heart valve deployment systems

• US 10,555,810 B2
• Filed: 02/26/2018
• Issued: 02/11/2020
• 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): Scherbel, Todd J
• Application Number:
  US15/905,625
• Publication Number:
  US 20180185146A1
• Time in Patent Office: 715 Days
• 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 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 and implanting a prosthetic heart valve to a native heart valve annulus, the system comprising:

a heart valve including a prosthetic valve having a support structure defining a flow orifice and having an inflow end and alternating commissures and cusps extending in an outflow direction, the support structure supporting flexible leaflets that coapt within the flow orifice in an outflow direction, the heart valve further including an expandable stent having a contracted state for delivery to an implant position and an expanded state;

a handle system connected to 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 handle system and distally past without contacting the heart valve leaflets such that the balloon is positioned to expand the heart valve.

2. The system of claim 1, wherein the expandable stent extends from the inflow end of the support structure and is balloon-expandable, and the balloon expands the expandable stent.

3. The system of claim 2, wherein the expandable stent has an undulating reinforcing ring with peaks and valleys on an end that is coupled to the inflow end of the support structure.

4. The system of claim 3, wherein the reinforcing ring is defined partly by gaps that enable the reinforcing ring to have a variable diameter.

5. The system of claim 3, wherein the reinforcing ring has a plurality of eyeholes that permit passage of sutures for attachment of the expandable stent to the support structure.

6. The system of claim 1, wherein the 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.

7. The system of claim 6, wherein the sleeve is threaded to the valve holder.

8. The system of claim 6, wherein the handle attaches to a proximal end of the valve holder with a snap-fit coupling.

9. The system of claim 1, wherein the expandable stent is self-expanding.

10. The system of claim 1, wherein the support structure of the heart valve is non-expandable.

11. A system for delivering and implanting a prosthetic heart valve to a native heart valve annulus, the system comprising:

a heart valve including a prosthetic valve having a support structure defining a flow orifice and having an inflow end and alternating commissures and cusps extending in an outflow direction, the support structure supporting flexible leaflets that coapt within the flow orifice in an outflow direction, the heart valve further including an expandable stent having a contracted state for delivery to an implant position and an expanded state;

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

a shaft that passes distally through the throughbore of the handle system and distally past without contacting the heart valve leaflets, the shaft terminating in a distal nose cone which surrounds an inflow end of the heart valve and acts as an external restraint to prevent premature expansion thereof.

12. The system of claim 11, wherein the nose cone has a conical or bell-shape.

13. The system of claim 12, wherein the expandable stent extends from the inflow end of the support structure and has a tapered distal end in its contracted state, and the nose cone fits closely over the tapered distal end.

14. The system of claim 11, wherein the expandable stent extends from the inflow end of the support structure and is balloon-expandable, and the shaft includes an inflatable balloon that expands the expandable stent.

15. The system of claim 14, wherein the expandable stent has an undulating reinforcing ring with peaks and valleys on an end that is coupled to the inflow end of the support structure.

16. The system of claim 11, wherein the handle system comprises a valve holder connected to an 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 shaft.

17. The system of claim 16, wherein the sleeve is threaded to the valve holder.

18. The system of claim 16, wherein the handle attaches to a proximal end of the valve holder with a snap-fit coupling.

19. The system of claim 11, wherein the expandable stent is self-expanding.

20. The system of claim 11, wherein the support structure of the heart valve is non-expandable.