Rapidly deployable surgical heart valves

• US 9,504,563 B2
• Filed: 01/27/2014
• Issued: 11/29/2016
• 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, Chen, Harvey H., Yambao, August R., Farhat, Lawrence J., Phung, Andrew, Brunnett, William C., Cristea, Carey L., Walls, Sara M., Zheng, Kevin W., Kalam, Faisal, Zeng, Qinggang
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US14/164,764
• Publication Number:
  US 20140200661A1
• Time in Patent Office: 1,037 Days
• Field of Search: 623/1.26, 623 217- 219, 623/900
• US Class Current: 1/1
• 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 implantation 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 an outflow or first end extending around the flow orifice and connected to the valve at the inflow end of the support structure, the frame having an inflow or second end projecting 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, wherein in the contracted state the frame tapers inward in a direction from the first end toward the second end, and wherein the first end of the frame has a scalloped shape with peaks and valleys, and in the contracted state the frame is cylindrical between the peaks and valleys and tapers inward from the valleys to the second end; 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 direction opposite the frame, and the valve leaflets are flexible and attach to the support structure and commissure posts.

3. The heart valve of claim 1, wherein the frame has a plurality of circumferential rows of expandable struts between axially-extending struts, and the first end of the frame includes a reinforcing ring defining the scalloped shape and interrupted by spaced eyelets for use in connecting the frame to the inflow end of the support structure with sutures.

4. The heart valve of claim 1, further including a sealing ring circumscribing the inflow end of the support structure.

5. The heart valve of claim 4, wherein the prosthetic heart valve is adapted for implant at an aortic valve annulus having an undulating shape, and an inflow side of the sealing ring has a scalloped shape to match the undulating shape of the aortic valve annulus.

6. The heart valve of claim 1, wherein the second end of the frame curls inward.

7. The heart valve of claim 1, wherein in the contracted state the second end of the frame has a trilobular shape as seen looking at the second end.

8. The heart valve of claim 4, wherein the sealing 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.

9. The heart valve of claim 8, wherein the sealing ring has a concave inflow shape that conforms to the heart valve annulus.

10. The heart valve of claim 4, wherein the sealing ring attaches to the support structure along a line of stitching, rendering it easily flexed outward.

11. A prosthetic heart valve for implantation 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 relatively stiff sealing ring secured to and projecting outward from the inflow end of the support structure; and

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 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, wherein the sealing ring and frame in its expanded state are spaced apart to sandwich the heart valve annulus therebetween, wherein the first end of the frame has a scalloped shape with peaks and valleys, and wherein in the contracted state the frame is cylindrical between the peaks and valleys and tapers inward from the valleys to the second end.

12. The heart valve of claim 11, wherein the sealing ring secures to the outside of the support structure along a cylindrical region of stitching to help reduce up and down flexing of the sealing ring.

13. The heart valve of claim 11, wherein the sealing ring comprises a closed-cell foam insert within a cloth cover.

14. The heart valve of claim 11, wherein the sealing ring has a concave inflow shape that conforms to the heart valve annulus.

15. The heart valve of claim 11, wherein the sealing ring comprises a foam insert with a reinforcing member embedded therein.

16. The heart valve of claim 15, wherein the reinforcing member is metallic.

17. The heart valve of claim 11, wherein the first end of the frame is secured at a butt joint to the inflow end of the support structure, and a lower end of the sealing ring overlaps the first end of the frame with stitching therebetween to enhance the stiffness of the assembly.

18. The heart valve of claim 11, wherein the prosthetic heart valve is adapted for implant at an aortic valve annulus having an undulating shape, and the sealing ring has a scalloped shape to match the undulating shape of the aortic valve annulus.

19. The heart valve of claim 18, further including a fabric covering around the plastically-expandable frame including an enlarged sealing flange surrounding the second end, the frame being sized to expand within the left ventricle and contact the wall thereof under the aortic annulus.

20. The heart valve of claim 11, wherein in the contracted state the second end of the frame has a trilobular shape as seen looking at the second end.