SYSTEMS AND METHODS FOR RAPIDLY DEPLOYING SURGICAL HEART VALVES

• US 20120065729A1
• Filed: 06/23/2011
• Published: 03/15/2012
• Est. Priority Date: 09/10/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Pintor, Rafael, Scott, Michael J., Chien, Thomas, Yambao, August R., Brunnett, William C., Chen, Harvey H., Farhat, Lawrence J., Phung, Andrew
• Granted Patent: US 8,641,757 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 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• 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 2230/0067 conical
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• 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 frame, 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 frame attached thereto. The frame 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 an integrated handle shaft and balloon catheter. A valve holder is stored with the heart valve and the handle shaft 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 plastically-expandable frame having a first end extending around the flow orifice and connected to the valve at the inflow end of the support structure, the frame 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 a wider expanded state for outward contact with an annulus; and

a fabric covering around the plastically-expandable frame including an enlarged sealing flange surrounding the second end.

2. The heart valve 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 heart valve of claim 1, wherein in the contracted state the frame is conical, tapering inward from the first end toward the second end.

4. The heart valve of claim 3, wherein in the expanded state the frame is conical, tapering outward from the first end toward the second end.

5. The heart valve of claim 1, further including a sewing ring circumscribing the inflow end of the support structure, wherein the frame attaches to the sewing ring.

6. The heart valve of claim 5, wherein the prosthetic valve comprises a commercially available valve and the suture-permeable ring is a sewing ring thereof having the plastically-expandable frame connected to the sewing ring.

7. The heart valve of claim 5, wherein the sewing ring comprises a solid yet compressible material that is relatively stiff so as to provide a seal against the annulus and has a concave inflow shape that conforms to the annulus.

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

providing a heart valve including a prosthetic valve having an expandable frame, the frame having a contracted state for delivery to an implant position and an expanded state configured for outward connection to the annulus, the heart valve being mounted on a holder having a proximal hub and lumen therethrough, the proximal hub connected to the distal end of a handle shaft having a lumen therethrough,

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

passing a first balloon catheter through the lumens of the handle shaft and the holder and within the heart valve, and inflating a balloon on the first balloon catheter;

deflating the balloon and retracting the first balloon catheter from within the heart valve, and removing the first balloon catheter from the handle shaft;

inserting a second balloon catheter into the handle shaft and passing the second balloon catheter through the lumens of the handle shaft and the holder to within the heart valve, and inflating a balloon on the second balloon catheter to expand the frame.

9. The method of claim 8, further including packaging the heart valve mounted on the holder separately from the handle shaft and the first balloon catheter.

10. The method of claim 8, wherein the contracted state of the frame is conical, and wherein the balloon on the balloon catheter has a midline positioned near the distal end of the frame prior to inflation.

11. The method of claim 8, wherein the contracted state of the frame is conical, and wherein the frame 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.

12. The method of claim 8, including increasing the orifice size of the heart valve annulus by 1.0-5.0 mm by plastically expanding the frame.

13. The method of claim 12, 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.

14. 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 frame extending from an inflow end thereof, the frame 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 malleable handle shaft 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 shaft, past the holder and through the heart valve.

15. The system of claim 14, wherein the prosthetic valve comprises a commercially available valve having a sewing ring, and wherein the frame attaches to the sewing ring.

16. The system of claim 14, wherein the contracted state of the frame is conical, tapering down in a distal direction.

17. The system of claim 14, wherein the contracted state of the frame is conical and tapers down in a distal direction, and wherein the balloon further includes a visible midline that is positioned near the distal end of the frame prior to inflation.

18. The system of claim 14, wherein the heart valve mounted on the holder is packaged separately from the handle shaft and the balloon catheter.

19. The system of claim 14, wherein the malleable handle shaft is made of aluminum.

20. The system of claim 14, wherein the balloon catheter has an inflation tube that extends through the lumen of the handle shaft and the OD of the inflation tube is more than 90% the ID of the handle shaft lumen.