Conformable prosthesis for implanting two-piece heart valves and methods for using them

• US 20060195184A1
• 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
• Granted Patent: US 7,717,955 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 2210/009 magnetic
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

A heart valve assembly includes an annular prosthesis and a valve prosthesis. The annular prosthesis includes an annular ring for dilating tissue within a biological annulus and a conformable sewing cuff extending radially from the annular member. The valve prosthesis includes a frame and a valve component. The annular ring is introduced into the biological annulus to dilate tissue surrounding the biological annulus and the sewing cuff conforms to tissue above the biological annulus. Fasteners are directed through the sewing cuff to secure the annular prosthesis to the biological annulus. The annular prosthesis may include a baleen element for biasing fabric on the annular ring outwardly to enhance sealing against the biological annulus. A valve prosthesis is then advanced into the sinus cavity, and secured relative to the annular prosthesis. The sewing cuff may enhance a seal between the valve prosthesis and annular prosthesis.

Claims

1. A prosthesis for receiving a prosthetic valve to replace a preexisting natural or prosthetic heart valve within a biological annulus adjacent a sinus cavity, comprising:

an annular member implantable within the biological annulus for dilating tissue surrounding the biological annulus;

a sewing cuff extending radially outwardly from the annular member, the sewing cuff being conformable for adopting a shape of tissue surrounding the sinus cavity above the biological annulus; and

one or more connectors for securing a prosthetic valve to the annular member.

2. The prosthesis of claim 1, wherein the sewing cuff is penetrable by fasteners for securing the sewing cuff to tissue surrounding the sinus cavity.

3. The prosthesis of claim 1, wherein the sewing cuff has a multiple lobular shape corresponding to the shape of the sinus cavity.

4. The prosthesis of claim 1, wherein the sewing cuff is resiliently conformable with the shape of the sinus cavity such that at least one of a circumference and a taper of the sewing cuff change to accommodate to the shape of the sinus cavity.

5. The prosthesis of claim 1, wherein the sewing cuff comprises a lattice extending around a circumference of the annular member.

6. The prosthesis of claim 5, wherein the lattice comprises a plurality of ribs at least partially defining openings.

7. The prosthesis of claim 5, wherein the lattice comprises a plurality of ribs extending from at least one of an upper surface and a lower surface of an annular core.

8. The prosthesis of claim 1, wherein the sewing cuff comprises a plurality of flexible elements extending from at least one of an upper and lower surface of the sewing cuff, the flexible elements being compressible for conforming to a shape of a prosthetic valve secured to the annular member to enhance sealing between the prosthetic valve and the annulus member.

9. The prosthesis of claim 1, wherein the sewing cuff comprises a flexible core and a fabric covering at least a portion of the core.

10. The prosthesis of claim 9, wherein the fabric also covers at least a portion of the annular member.

11. The prosthesis of claim 10, further comprising a flexible skirt extending around the annular member within the fabric covering, the flexible skirt comprising a plurality of baleen elements for biasing at least a portion of the fabric outwardly away from the annular member.

12. The prosthesis of claim 1, wherein the one or more connectors comprise a clip secured relative to the annular member.

13. The prosthesis of claim 1, wherein the one or more connectors comprise a plurality of magnets on the annular member.

14. 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 and a sewing cuff extending radially outwardly from the annular member;

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

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

15. The heart valve assembly of claim 14, wherein the one or more connectors secure the prosthetic valve in a predetermined orientation relative to the annular prosthesis.

16. The heart valve assembly of claim 14, wherein the one or more connectors comprise a clip on the annular prosthesis for engaging a portion of the prosthetic valve.

17. The heart valve assembly of claim 14, the sewing cuff being resiliently flexible for conforming to the multiple lobular shape of the prosthetic valve when the prosthetic valve is secured to annular prosthesis to enhance a seal between the prosthetic valve and the annular prosthesis.

18. The heart valve assembly of claim 14, wherein the annular member is compressible radially inwardly to facilitate insertion into the biological annulus, the annular member being biased to expand radially outwardly to dilate the tissue surrounding the biological annulus.

19. The heart valve assembly of claim 14, the annular prosthesis further comprising a fabric covering at least a portion of the annular member, and a baleen element disposed between the fabric and the annular member for biasing at least a portion of the fabric outwardly away from the annular member.

20. The heart valve assembly of claim 14, wherein the annular member has a substantially circular shape.

21. A prosthesis for receiving a prosthetic valve, comprising:

an annular member sized for delivery within a biological annulus, the annular member comprising a fabric covering;

a baleen element disposed between the annular member and the fabric covering for biasing a portion of the fabric covering outwardly away from the annular member;

a sewing cuff extending radially outwardly from the annular member, the sewing cuff comprising a core resiliently conformable with anatomy surrounding the biological annulus and fabric covering at least a portion of the core; and

one or more connectors for engaging a valve prosthesis.

22. The prosthesis of claim 21, wherein the sewing cuff extends from an upper edge of the annular member, and the baleen element biases the fabric covering radially outwardly along a lower edge of the annular member.