Rapidly deployable surgical heart valves

• US 9,370,418 B2
• Filed: 03/12/2013
• Issued: 06/21/2016
• Est. Priority Date: 09/10/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Kim, Grace Myong, Ta, Edwin T., Pintor, Rafael, Scott, Michael J., Zeng, Qinggang, Chung, Visith, Campbell, Louis A., Lin, David S., Norasing, Peng
• Primary Examiner(s): Rosen, Eric
• Assistant Examiner(s): MANNAN, MIKAIL A
• Application Number:
  US13/797,591
• Publication Number:
  US 20130190862A1
• Time in Patent Office: 1,197 Days
• Field of Search: 623 124- 126, 623 211- 218, 623/900
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2220/005 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

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 stent frame, thereby enabling attachment to the annulus without sutures. The prosthetic valve may be a commercially available valve with a sewing ring and the stent frame attached thereto. The stent frame may expand from a conical deployment shape to a conical expanded shape, and may have a cloth covering its entirety as well as a plush sealing flange around its periphery to prevent paravalvular leaking.

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 stent frame terminating in a first end extending around the flow orifice and connected to the valve at the inflow end of the support structure, the stent frame terminating in 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 stent frame including an enlarged sealing flange connected to an exterior surface of the fabric covering and surrounding at least the second end to contact the annulus and prevent paravalvular leaking, wherein the fabric sealing flange comprises a strip of textured PET fabric that has a smooth side and a plush textured side, and the strip is connected at free ends to form a ring and folded in half about its mid-section and having its free circumferential ends connected at a seam so that the smooth sides face toward each other and plush textured sides face away from each other.

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

3. The heart valve of claim 2, wherein in the expanded state the stent frame is conical, tapering outward from the first end toward the second end.

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

5. The heart valve of claim 4, wherein the sewing ring comprises a solid yet compressible material that is stiff so as to provide a seal against the annulus and has a concave inflow shape that conforms to the annulus.

6. The heart valve of claim 1, wherein the sealing flange extends in a ring only around the second end of the stent frame and does not extend up to the first end.

7. The heart valve of claim 1, wherein the sealing flange covers the entire exterior of the stent frame.

8. The heart valve of claim 1, further including a sewing ring circumscribing the inflow end of the support structure and having an undulating shape that matches the shape of the first end of the stent frame, and the first end of the stent frame attaches to the sewing ring with sutures.

9. The heart valve of claim 8, wherein the stent frame first end has peaks and valleys that match the sewing ring, and the stent frame in the contracted state extends away from the sewing ring in a tubular portion between the peaks and valleys and then angles inward in a conical portion to the second end.

10. 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 stent frame having a first end extending around the flow orifice and connected to the valve at the inflow end of the support structure, the stent 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, wherein the stent frame has an undulating first end with peaks and valleys that conform to a shape of the inflow end of the support structure, and the stent frame in the contracted state extends away from the inflow end of the support structure in a tubular portion between the peaks and valleys and then angles inward in a conical portion to the second end, wherein in the contracted state the stent frame angles inward in a conical portion and the second end defines an orifice that is non-circular, and wherein the second end is circular when in the expanded state; and

a fabric sealing flange attached to the stent frame comprising a strip of textured PET fabric that has a smooth side and a plush textured side, and the strip is connected at free ends to form a ring and folded in half about its mid-section and having its free circumferential ends connected at a seam so that the smooth sides face toward each other and plush textured sides face away from each other.

11. The heart valve of claim 10, wherein in the contracted state the stent frame second end defines an orifice that is a shape with three lobes.

12. The heart valve of claim 10, further including a sewing ring circumscribing the inflow end of the support structure and having an undulating shape that matches the shape of the first end of the stent frame and attaches thereto with sutures.

13. The heart valve of claim 10, wherein the fabric sealing flange extends in a ring only around the second end of the stent frame and does not extend up to the tubular portion.

14. The heart valve of claim 10, wherein the fabric sealing flange covers the entire exterior of the stent frame.

15. The heart valve of claim 10, wherein the fabric sealing flange comprises a fabric panel located only on the interior of the stent frame and the plush textured side provides loops of material that project through apertures in the stent frame.

16. The heart valve of claim 10, wherein the fabric sealing flange has a gradually variable thickness which is thickest at the second end of the stent frame.

17. The heart valve of claim 10, further including a fabric cover surrounding the stent frame and to the exterior of which the sealing flange attaches.

18. 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 stent frame having a first end extending around the flow orifice and connected to the valve at the inflow end of the support structure, the stent 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 stent frame including an enlarged sealing flange surrounding the second end to contact the annulus and prevent paravalvular leaking, wherein the sealing flange extends in a ring only around the second end of the stent frame and does not extend up to the first end, wherein the fabric sealing flange comprises a strip of textured PET fabric that has a smooth side and a plush textured side, and the strip is connected at free ends to form a ring and folded in half about its mid-section and having its free circumferential ends connected at a seam so that the smooth sides face toward each other and plush textured sides face away from each other.

19. The heart valve of claim 18, wherein in the contracted state the stent frame is conical, tapering inward from the first end toward the second end, and wherein in the expanded state the stent frame is conical, tapering outward from the first end toward the second end.

20. The heart valve of claim 18, wherein in the contracted state the stent frame angles inward in a conical portion and the second end defines an orifice that is non-circular, and wherein the second end is circular when in the expanded state.

21. The heart valve of claim 18, wherein the stent frame has an undulating first end with peaks and valleys, and further including a sewing ring circumscribing the inflow end of the support structure and having an undulating shape that matches the shape of the first end of the stent frame.

22. The heart valve of claim 18, wherein the stent frame in the contracted state extends away from the sewing ring in a tubular portion between the peaks and valleys and then angles inward in a conical portion to the second end.