Two piece heart valves including multiple lobe valves and methods for implanting them

• US 20060195185A1
• Filed: 02/28/2005
• Published: 08/31/2006
• Est. Priority Date: 02/28/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Drews, Michael J., Gurskis, Donnell W., Lane, Ernest, Svanidze, Oleg
• Granted Patent: US 8,083,793 B2
• Time in Patent Office: Days
• US Class Current: 623/2.38
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

A heart valve assembly including an annular prosthesis implantable within a biological annulus, a prosthetic valve including a multiple lobular shape for implantation above the biological annulus, and one or more connectors for securing the prosthetic valve to the annular prosthesis. A flexible sewing cuff extends radially from the annular prosthesis that is resiliently flexible for conforming to the multiple lobular shape of the prosthetic valve to enhance a seal between the prosthetic valve and the annular prosthesis. The sewing cuff may include a core resiliently conformable with anatomy surrounding the biological annulus and fabric covering at least a portion of the core.

Claims

1. A heart valve assembly, comprising:

an annular prosthesis implantable within a natural valve annulus, the annulus prosthesis comprising an annular member for dilating tissue surrounding the annulus;

a prosthetic valve comprising a multiple lobular shape for implantation above the natural valve annulus;

one or more connectors for securing the prosthetic valve to the annular prosthesis; and

a flexible skirt extending radially from at least one of the annular prosthesis and the prosthetic valve for enhancing a seal between the prosthetic valve and the annular prosthesis.

2. The heart valve assembly of claim 1, wherein the annular member has a substantially circular shape.

3. The heart valve assembly of claim 1, the flexible skirt comprising a sewing cuff extending radially outwardly from the annular member.

4. The heart valve assembly of claim 3, the sewing cuff being resiliently flexible for conforming to the multiple lobular shape of the prosthetic valve to enhance a seal between the prosthetic valve and the annular prosthesis.

5. The heart valve assembly of claim 3, the sewing cuff comprising a core resiliently conformable with anatomy surrounding the biological annulus and fabric covering at least a portion of the core.

6. The heart valve assembly of claim 5, wherein the core comprises one or more circumferential elements extending around the circumference and a plurality of transverse elements extending transversely from the one or more circumferential elements.

7. The heart valve assembly of claim 5, wherein the core comprises a plurality of flexible ribs extending upwardly.

8. The heart valve assembly of claim 5, wherein the sewing cuff defines a tapered frusto-conical shape in a relaxed state, the core being sufficiently flexible that the shape of the sewing cuff changes as the annular member is delivered into the tissue annulus.

9. The heart valve assembly of claim 8, wherein at least a portion of the sewing cuff becomes more horizontal and another portion of the sewing cuff becomes more vertical when the shape of the sewing cuff changes.

10. The heart valve assembly of claim 1, wherein the one or more connectors comprise a plurality of clips receivable through a portion of the prosthetic valve and the sewing cuff.

11. The heart valve assembly of claim 1, wherein the one or more connectors comprise a clip on the annular prosthesis for receiving a portion of the prosthetic valve thereunder.

12. The heart valve assembly of claim 1, wherein the one or more connectors comprise a plurality of magnets on the annular member and the prosthetic valve.

13. The heart valve assembly of claim 1, wherein the prosthetic valve comprises three lobes.

14. A method for implanting a prosthetic heart valve assembly to replace a natural or prosthetic heart valve implanted within a biological annulus below a sinus cavity, the method comprising:

introducing an annular member into the biological annulus such that a sewing cuff extending from the annular member is disposed within the sinus cavity;

implanting the annular member within the biological annulus by directing a plurality of fasteners through the sewing cuff into tissue adjacent the biological annulus;

advancing a multiple-lobular valve prosthesis into the sinus cavity; and

securing the valve prosthesis relative to the annular member.

15. The method of claim 14, wherein the annular member is rotationally aligned as it is introduced into the biological annulus to align an undulation in the annular member above an underlying tissue structure.

16. The method of claim 14, wherein the annular member is rotationally aligned as it is introduced to align an ear extending from the sewing cuff with an RC/NC commissure within the sinus cavity.

17. The method of claim 14, wherein a fabric covering extends radially outwardly from a lower edge of the annular member such that the fabric covering is disposed below the biological annulus when the annular member is implanted.

18. The method of claim 17, wherein the annular member is radially contracted before being introduced into the biological annulus, and wherein the annular member is expanded by releasing the annular member, whereupon the annular member resiliently expands within the biological annulus to at least partially dilate the biological annulus.

19. The method of claim 17, wherein the annular member comprises a fabric covering, at least a portion of which is biased radially outwardly away from the annular member, the outwardly biased portion extending below the biological annulus when the annular member is implanted, thereby enhancing a seal between the outwardly biased portion and surrounding tissue below the biological annulus.

20. A method for implanting a prosthetic heart valve assembly to replace a natural or prosthetic heart valve implanted within a biological annulus below a sinus cavity, the method comprising:

introducing an annular prosthesis into the biological annulus such that a sewing cuff extending from the annular prosthesis is disposed within the sinus cavity;

implanting the annular prosthesis within the biological annulus by directing a plurality of fasteners through the sewing cuff into tissue adjacent the biological annulus;

introducing a multiple-lobular valve prosthesis into the sinus cavity;

orienting the valve prosthesis diagonally relative to the annular prosthesis such that one or more lobes of the valve prosthesis are received under one or more connectors extending from the annular prosthesis; and

directing the valve prosthesis substantially horizontally against the annular prosthesis such that one or more additional lobes of the valve prosthesis are received under the one or more connectors to secure the valve prosthesis relative to the annular prosthesis.