TWO-PIECE PROSTHETIC VALVES WITH SNAP-IN CONNECTION AND METHODS FOR USE

• US 20090192599A1
• Filed: 04/06/2009
• Published: 07/30/2009
• 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
• Granted Patent: US 7,951,197 B2
• Time in Patent Office: Days
• 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 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.

2. The prosthetic heart valve of claim 1, wherein the plurality of receptacles are attached to the other of the gasket member and the valve member around a periphery thereof.

3. The prosthetic heart valve of claim 2, wherein the receptacles are attached at locations corresponding to commissures of the valve member.

4. The prosthetic heart valve of claim 1, wherein the engagement members extend from the frame of the valve member, and the receptacles are attached to the gasket member.

5. The prosthetic heart valve of claim 4, wherein the engagement members are integrally formed with the frame.

6. The prosthetic heart valve of claim 1, wherein each engagement element comprises a pair of tabs including tapered first edges and substantially blunt second edges, the tabs disposed opposite one another on the engagement element.

7. The prosthetic heart valve of claim 1, wherein each receptacle comprises a leg that is resiliently deflectable to accommodate receiving a respective engagement member in the pocket of the receptacle.

8. The prosthetic heart valve of claim 7, wherein the leg is deflectable radially inwardly 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.

9. The prosthetic heart valve of claim 1, wherein the receptacles are configured to provide an audible click or tactile click when the engagement members are engaged with the respective fasteners.

10. The prosthetic heart valve of claim 1, 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.

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

an annular member advanceable into a tissue annulus;

a sewing cuff extending radially from the annular member;

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.

12. The prosthesis of claim 11, 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.

13. The prosthesis of claim 12, wherein the layer of fabric comprises an opening overlying each receiver for receiving an engagement member therethrough.

14. A prosthetic heart valve, comprising:

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

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

a plurality 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.

15. The prosthetic heart valve of claim 14, wherein the engagement members extend from the frame of the valve member, and the receivers are attached to the gasket 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 14, 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.

18. The prosthetic heart valve of claim 14, wherein each engagement element comprises a tapered or rounded first edge to guide the engagement element into the respective pocket, and a substantially blunt second edge to prevent the engagement element from being removed subsequently from the respective pocket.

19. The prosthetic heart valve of claim 18, wherein each engagement element comprises a pair of detents including tapered or rounded first edges and substantially blunt second edges.

20. The prosthetic heart valve of claim 19, wherein the detents are disposed opposite one another on the engagement element.

21. A method for implanting a prosthetic valve within a biological annulus within a patient'"'"'s body, the prosthetic valve comprising a gasket member including an annular ring advanceable into a tissue annulus and a sewing cuff extending radially from the annular ring, and a valve member comprising a frame carrying a plurality of valve elements, the method comprising:

introducing the gasket member into the biological annulus such that the annular ring is disposed within the biological annulus and the sewing cuff is disposed supra-annularly above the biological annulus;

securing the gasket member relative to the biological annulus;

after securing the gasket member, introducing the valve member into the patient'"'"'s body toward the biological annulus; and

securing the valve member relative to the gasket member by engaging a plurality of engagement members extending from one of the gasket member and the valve member to a plurality of receptacles on the other of the gasket member and the valve member, each engagement member comprising one or more tabs including tapered first edges and substantially blunt second edges, each receptacle comprising a pocket for receiving a respective engagement member therein and one or more tapered surfaces for guiding a respective engagement member into the receptacle, the substantially blunt second edges preventing removal of the engagement member from the receptacle.

22. The method of claim 21, wherein the gasket member is introduced into the patient'"'"'s body in a radially compressed configuration, the method further comprising expanding the gasket member such that the annular ring to direct tissue surrounding the biological annulus radially outwardly.

23. The method of claim 21, wherein the frame of the valve member has a multiple lobed shape, and wherein the valve member is oriented within the patient'"'"'s body to align the engagement members with the receptacles.