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

• US 7,717,955 B2
• Filed: 02/28/2005
• Issued: 05/18/2010
• 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
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): Ganesan; Suba
• Application Number:
  US11/069,081
• Publication Number:
  US 20060195184A1
• Time in Patent Office: 1,905 Days
• Field of Search: 623 212- 219, 623/2.38, 623/2.41, 623/2.39, 623/2.4, 623/904
• US Class Current: 623/2.41
• 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 comprising an annular band substantially enclosed within a fabric covering disposed around a central longitudinal axis and implantable within the biological annulus for dilating tissue surrounding the biological annulus, the annular member being 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;

a sewing cuff comprising a flexible core at least partially covered with fabric extending radially outwardly and upwardly from an upper portion of the annular member such that the core comprises a tapered shape in a relaxed state defining an angle relative to the longitudinal axis, 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 annular member is biased to a circular shape around the longitudinal axis and the sewing cuff has a multiple lobular outer shape radially relative to the longitudinal axis and 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 core of 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 core, 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 fabric at least partially covering the core also covers at least a portion of the annular band of the annular member.

10. The prosthesis of claim 9, further comprising a flexible skirt extending radially 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 radially outwardly away from the annular member.

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

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

13. The prosthesis of claim 1, wherein the sewing cuff extends radially outwardly from an upper edge of the annular member.

14. The prosthesis of claim 1, wherein the core comprises elastomeric material.

15. The prosthesis of claim 1, wherein the annular band has a thickness between about 0.1-0.5 millimeter.

16. The prosthesis of claim 15, wherein the annular band has a width substantially parallel to the longitudinal axis between about 1.5-2.5 millimeters.

17. The prosthesis of claim 1, further comprising a plurality of fasteners deliverable through the sewing cuff into tissue for secure the prosthesis relative to a biological annulus.

18. The prosthesis of claim 1, wherein the fabric covering comprises fabric wrapped around the annular band.

19. The prosthesis of claim 1, wherein the tapered shape of the core defines an angle relative to the longitudinal axis between about twenty and forty five degrees (20-45°

).

20. A multiple component heart valve assembly, comprising:

an annular prosthesis disposed around a central longitudinal axis and implantable within a natural valve annulus, the annular prosthesis comprising an annular band substantially enclosed within a fabric covering for dilating tissue surrounding the annulus and a conformable sewing cuff comprising a flexible core at least partially covered with fabric extending radially outwardly and upwardly from an upper portion of the annular member such that the core comprises a tapered shape in a relaxed state defining an angle relative to the longitudinal axis;

a prosthetic tissue valve separate and disconnected from the annular prosthesis, the valve comprising a multiple lobular shape radially relative to the longitudinal axis for implantation above the natural valve annulus; and

one or more connectors for securing the prosthetic tissue valve to the annular prosthesis after the annular prosthesis has been introduced into the natural valve annulus.

21. The heart valve of claim 20, wherein the one or more connectors secure the prosthetic tissue valve in a predetermined radial orientation around the longitudinal axis relative to the annular prosthesis.

22. The heart valve of claim 20, wherein the one or more connectors comprise a clip on the annular prosthesis for engaging a portion of the prosthetic tissue valve.

23. The heart valve of claim 20, the sewing cuff being resiliently flexible for conforming to the multiple lobular shape of the prosthetic tissue valve when the prosthetic tissue valve is secured to annular prosthesis, the sewing cuff being configured to enhance a seal between the prosthetic tissue valve and the annular prosthesis.

24. The heart valve of claim 20, 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.

25. The heart valve of claim 20, the annular prosthesis further comprising a baleen element disposed radially around the annular member and between the fabric and the annular member for biasing at least a portion of the fabric radially outwardly away from the annular member.

26. The heart valve of claim 20, wherein the annular member has a substantially circular shape around the longitudinal axis.

27. The prosthesis of claim 20, wherein the sewing cuff extends radially outwardly from an upper edge of the annular member.

28. The prosthesis of claim 20, the sewing cuff being conformable for adopting a shape of tissue surrounding a sinus cavity above the annulus.

29. 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 comprising an annular band substantially enclosed within a fabric covering disposed around a central longitudinal axis and implantable within the biological annulus for dilating tissue surrounding the biological annulus, the annular member being compressible radially inwardly towards the longitudinal axis to facilitate insertion into the biological annulus, the annular member being biased to expand radially outwardly to dilate the tissue surrounding the biological annulus;

a sewing cuff extending radially outwardly from an upper portion of the annular member, the sewing cuff being conformable for adopting a shape of tissue surrounding the sinus cavity above the biological annulus, wherein the sewing cuff comprises a flexible core and a fabric covering at least a portion of the core, the core extending radially outwardly and upwardly from an upper portion of the annular member such that the core comprises a tapered shape in a relaxed state defining an angle relative to the longitudinal axis; and

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

30. The prosthesis of claim 29, wherein the fabric at least partially covering the core also comprises at least a portion of the fabric covering substantially enclosing the annular member.

31. The prosthesis of claim 29, wherein the core comprises elastomeric material.