Unitary Quick Connect Prosthetic Heart Valve and Deployment System and Methods

• US 20100331972A1
• Filed: 06/23/2010
• Published: 12/30/2010
• Est. Priority Date: 06/26/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Cristea, Carey, Campbell, Louis A., Chau, Mark, Pintor, Rafael, Oba, Travis, Zeng, Qinggang, Yambao, August, Huntley, Tammy, Kalam, Faisal
• Granted Patent: US 8,348,998 B2
• Time in Patent Office: Days
• 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 prosthetic heart valve for implant at a heart valve annulus, comprising:

a non-expandable, non-collapsible annular support structure defining a flow orifice and having an inflow end;

valve leaflets attached to the support structure and mounted to alternately open and close across the flow orifice;

a suture-permeable ring circumscribing the inflow end of the support structure; and

a plastically-expandable coupling stent having a first end extending around the flow orifice and connected to the valve at the inflow end of the support structure, the coupling stent having a second end projecting in the inflow direction away from the support structure and being capable of assuming a contracted state for delivery to an implant position and an expanded state wider than the first end for outward contact with an annulus.

2. The system of claim 1, wherein the support structure includes a plurality of commissure posts projecting in an outflow direction, and the valve leaflets are flexible and attach to the support structure and commissure posts.

3. The system of claim 1, wherein the suture-permeable ring is a sewing ring, and wherein the coupling stent attaches to the sewing ring.

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

5. The system of claim 4, wherein in the expanded state the coupling stent is conical, tapering outward from the first end toward the second end.

6. The system of claim 5, wherein the coupling stent comprises a plurality of radially expandable struts at least some of which are arranged in rows, and wherein the distalmost row has the greatest capacity for expansion from the contracted state to the expanded state.

7. The system of claim 1, wherein the prosthetic valve comprises a commercially available valve and the suture-permeable ring is a sewing ring thereof having the plastically-expandable coupling stent connected to the sewing ring.

8. A method of delivery and implant of a prosthetic heart valve system, comprising:

providing a heart valve including a prosthetic valve having a non-expandable, non-collapsible orifice, 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 configured for outward connection to the annulus;

advancing the heart valve with the coupling stent in its contracted state to an implant position adjacent the annulus; and

expanding the coupling stent to the expanded state in contact with and connected to the annulus.

9. The method of claim 8, further including mounting the heart valve on a holder having a proximal hub and lumen therethrough, and mounting the holder on the distal end of a handle having a lumen therethrough, the method including passing a balloon catheter through the lumen of the handle and the holder and within the heart valve, and inflating a balloon on the balloon catheter to expand the coupling stent.

10. The method of claim 9, further including packaging the heart valve mounted on the holder separately from the handle and the balloon catheter.

11. The method of claim 9, wherein the contracted state of the coupling stent is conical, and wherein the balloon on the balloon catheter has a larger distal expanded end than its proximal expanded end so as to apply greater expansion deflection to the coupling stent than to the prosthetic valve.

12. The method of claim 8, wherein the contracted state of the coupling stent is conical, and wherein the coupling stent comprises a plurality of radially expandable struts at least some of which are arranged in rows, and wherein the row farthest from the prosthetic valve has the greatest capacity for expansion from the contracted state to the expanded state.

13. The method of claim 8, wherein the coupling stent comprises a plurality of radially expandable struts, and a row farthest from the prosthetic valve has alternating peaks and valleys, and the method includes expanding the distal end of the coupling stent more than the rest of the coupling stent so that the peaks in the row farthest from the prosthetic valve project outward into the annulus.

14. The method of claim 8, including increasing the orifice size of the heart valve annulus by 1.0-5 mm by plastically expanding the coupling stent.

15. The method of claim 14, wherein the prosthetic valve of the valve component is selected to have an orifice size that matches the increased orifice size of the heart valve annulus.

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

a heart valve including a prosthetic valve having a non-expandable, non-collapsible orifice, 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 a proximal end of the heart valve;

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 catheter, the balloon extending distally through the handle, past the holder and through the heart valve.

17. The system of claim 16, wherein the prosthetic valve comprises a commercially available valve having a sewing ring, and wherein the coupling stent attaches to the sewing ring.

18. The system of claim 16, wherein the contracted state of the coupling stent is conical, tapering down in a distal direction.

19. The system of claim 16, wherein the contracted state of the coupling stent is conical and tapers down in a distal direction, and wherein the balloon catheter further includes a generally conical nose cone on a distal end thereof that extends through the heart valve and engages a distal end of the coupling stent in its contracted state.

20. The system of claim 16, 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 the hub of the holder to enable manual manipulation of the heart valve using the distal section prior to connection with the proximal handle section.

21. The system of claim 20, wherein the balloon catheter and proximal handle section are packaged together with the balloon within the proximal section lumen.

22. The system of claim 16, wherein the heart valve mounted on the holder is packaged separately from the handle and the balloon catheter.