Two-piece prosthetic valves with snap-in connection and methods for use

• US 7,513,909 B2
• Filed: 04/10/2006
• Issued: 04/07/2009
• Est. Priority Date: 04/08/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Arbor Surgical Technologies, Inc. (Medtronic Plc)
• Inventors: Lane, Ernest, Lee, Shouyan, Huang, Charles
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US11/279,246
• Publication Number:
  US 20060235508A1
• Time in Patent Office: 1,093 Days
• Field of Search: 623/2.4, 623/2.38, 623/2.1
• US Class Current: 623/2.4
• 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

Abstract

A prosthetic heart valve assembly includes a gasket member and a valve member including a plurality of fasteners and a plurality of engagement members corresponding to the fasteners. The fasteners and/or engagement members may be configured to guide the engagement members into engagement with the fasteners. For example, the fasteners may include U-shaped spring-biased clips, e.g., attached to a core or other portion of a sewing cuff of the gasket member, and the engagement members may include latches or barbed protrusions that engage one or more holes in the fasteners. During use, the gasket member is introduced into a tissue annulus, and secured to the annulus, e.g., using a plurality of clips directed through the sewing cuff. The valve member is then introduced into the annulus and the engagement members are snapped or otherwise guided into engagement with the fasteners to secure the valve member relative to the gasket member.

Claims

1. A prosthesis for receiving a valve prosthesis, comprising:

an annular ring advanceable into a tissue annulus;

a sewing cuff extending radially from the annular ring;

a plurality of receivers secured to the sewing cuff, each receiver comprising a pair of legs defining a pocket, the legs being deflectable away from one another to accommodate receiving an engagement member from a valve prosthesis in the pocket, the legs being resiliently deflectable towards one another after an engagement member is received in the pocket for securing the engagement member to the receiver; and

wherein the legs of each receiver comprise tapered upper edges for guiding an engagement member into the pocket.

2. The prosthesis of claim 1, wherein the sewing cuff comprises a core to which the receivers are secured, the sewing cuff further comprising a layer of fabric overlying the core.

3. The prosthesis of claim 2, wherein the layer of fabric comprises an opening overlying each receiver for receiving an engagement member therethrough.

4. A prosthesis for receiving a valve prosthesis, comprising:

an annular ring advanceable into a tissue annulus;

a sewing cuff extending radially from the annular ring;

a plurality of receivers secured to the sewing cuff, each receiver comprising a pair of legs defining a pocket, the legs being deflectable away from one another to accommodate receiving an engagement member from a valve prosthesis in the pocket, the legs being resiliently deflectable towards one another after an engagement member is received in the pocket for securing the engagement member to the receiver,

wherein the receivers comprises spring-biased clips mounted to posts on the sewing cuff.

5. A prosthetic heart valve, comprising:

a gasket member comprising an annular ring advanceable into a tissue annulus, and a sewing cuff extending radially from the annular ring;

a valve member comprising a frame carrying a plurality of valve elements;

a plurality of engagement members extending from one of the gasket member and the valve member; and

a plurality of receivers on the other of the gasket member and the valve member, each receiver comprising a pair of legs defining a pocket, the legs being deflectable away from one another to accommodate receiving a respective engagement member in the pocket, the legs being resiliently deflectable towards one another after the engagement member is received in the pocket for securing the engagement member to the receiver, thereby securing the valve member relative to the gasket member,

wherein the sewing cuff comprises a flexible core, and wherein the receivers are attached to the core, and

wherein the receivers comprises spring clips attached to mounts extending from the core.

6. The prosthetic heart valve of claim 5, wherein the engagement members extend from the frame of the valve member, and the receivers are attached to the gasket member.

7. The prosthetic heart valve of claim 6, wherein the engagement members are integrally formed with the frame.

8. The prosthetic heart valve of claim 5, wherein each engagement member comprises at least one detent, and each receiver comprises at least one hole for receiving the respective detent therein when the engagement member is received in the pocket.

9. The prosthetic heart valve of claim 5, wherein each engagement member comprises a tapered or rounded first edge to guide the engagement member into the respective pocket, and a substantially blunt second edge to prevent the engagement member from being removed subsequently from the respective pocket.

10. The prosthetic heart valve of claim 9, wherein each engagement member comprises a pair of detents including tapered or rounded first edges and substantially blunt second edges.

11. The prosthetic heart valve of claim 10, wherein the detents are disposed opposite one another on the engagement member.

12. A prosthetic heart valve, comprising:

a gasket member comprising an annular ring advanceable into a tissue annulus, and a sewing cuff extending radially from the annular ring;

a valve member comprising a frame carrying a plurality of valve elements;

a plurality of engagement members extending from one of the gasket member and the valve member, the engagement members comprising tabs including tapered first edges and substantially blunt second edges; and

a plurality of receptacles on the other of the gasket member and the valve member comprising a pocket for receiving respective engagement members therein, each receptacle comprising one or more tapered surfaces for guiding a respective engagement member into the receptacle, the substantially blunt second edges preventing removal of the engagement members from the receptacles,

wherein the sewing cuff comprises a flexible core, and wherein the receptacles comprises spring clips attached to mounts extending from the core.

13. The prosthetic heart valve of claim 12, wherein the plurality of receptacles are attached to the flexible core of the gasket member around a periphery thereof.

14. The prosthetic heart valve of claim 13, wherein the receptacles are attached at locations corresponding to commissures of the valve member.

15. The prosthetic heart valve of claim 12, wherein the engagement members extend from the frame of the valve member.

16. The prosthetic heart valve of claim 15, wherein the engagement members are integrally formed with the frame.

17. The prosthetic heart valve of claim 12, wherein each receptacle comprises at least one hole for receiving a respective tab therein when the engagement member is received in the receptacle.

18. The prosthetic heart valve of claim 12, wherein each engagement member comprises a pair of tabs including tapered first edges and substantially blunt second edges, the tabs disposed opposite one another on the engagement member.

19. The prosthetic heart valve of claim 12, wherein each receptacle comprises a leg that is resiliently deflectable to accommodate receiving a respective engagement member in the pocket of the receptacle.

20. The prosthetic heart valve of claim 19, wherein the leg is deflectable from an original position to accommodate receiving the respective engagement member in the pocket, and the leg is resiliently biased to return to the original position to secure the engagement member within the receptacle.

21. The prosthetic heart valve of claim 12, wherein each receptacle comprises funnel-shaped ends defining the tapered surfaces.

22. The prosthetic heart valve of claim 12, wherein the receptacles are configured to provide an audible click or tactile click when the engagement members are engaged with the respective fasteners.

23. The prosthetic heart valve of claim 12, wherein each receptacle comprises at least one feature for engaging with the substantially blunt edge of a respective tab to prevent removal of the engagement member from the receptacle.

24. The prosthetic heart valve of claim 12, wherein the engagement members are integrally formed with one of the valve member and the gasket member, and the receptacles are attached to the other of the valve member and the gasket member.