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

• US 10,226,331 B2
• Filed: 06/27/2016
• Issued: 03/12/2019
• Est. Priority Date: 02/28/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Lane, Ernest, Drews, Michael J., Gurskis, Donnell W.
• Primary Examiner(s): Ganesan, Suba
• Application Number:
  US15/193,257
• Publication Number:
  US 20160324631A1
• Time in Patent Office: 988 Days
• 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 prosthetic heart valve for implantation at a biological annulus, the prosthetic heart valve comprising:

a sealing member comprising an annular member, a fabric member, and a baleen element, the sealing member having a first diameter in a contracted state and a second diameter in an expanded state, the second diameter being greater than the first diameter, the fabric member covering at least a portion of the baleen element and at least a portion of the annular member, wherein, in the contracted state, the baleen element is compressed against the annular member and in the expanded state, an angle between the annular member and the baleen element increases such that the baleen element billows at least a portion of the fabric member outwardly away from the annular member as the sealing member transitions from the contracted state to the expanded state within the biological annulus;

wherein the baleen element is positioned exterior with respect to the annular member in both the contracted and expanded states;

the sealing member further having a lattice extending around a circumference of the annular member; and

a valve member attached to the sealing member.

2. The prosthetic heart valve of claim 1, wherein the sealing member is penetrable by fasteners for securing the sealing member to tissue of the biological annulus.

3. The prosthetic heart valve of claim 1, wherein the sealing member has a multiple lobular shape corresponding to the shape of tissue of the biological annulus.

4. The prosthetic heart valve of claim 1, wherein the sealing member is resiliently conformable with a shape of the biological annulus such that at least one of a circumference and a taper of the sealing member change to accommodate to the shape of the biological annulus.

5. The prosthetic heart valve of claim 1, wherein the lattice comprises a plurality of ribs at least partially defining openings.

6. The prosthetic heart valve of claim 1, further comprising a core, wherein the lattice comprises a plurality of ribs extending from at least one of an upper surface and a lower surface of the core.

7. The prosthetic heart valve of claim 1, wherein the lattice has a plurality of enclosed openings that are completely open and free from any material.

8. The prosthetic heart valve of claim 1, wherein the lattice has a plurality of recesses in which a wall of core material is positioned.

9. The prosthetic heart valve of claim 8, wherein the lattice comprises a plurality of ribs extending from at least one of an upper surface and a lower surface of the annular member, the ribs being compressible for conforming to a shape of the valve member attached to the sealing member to enhance sealing between the valve member and the sealing member.

10. The prosthetic heart valve of claim 1, the baleen element comprising a plurality of finger elements for billowing at least a portion of the fabric member outwardly away from the annular member.

11. The prosthetic heart valve of claim 10, wherein the plurality of finger elements have varying lengths.

12. The prosthetic heart valve of claim 1, wherein the valve member is connected to the sealing member with at least one connector.

13. The prosthetic heart valve of claim 12, wherein the at least one connector comprises a clip.

14. The prosthetic heart valve of claim 12, wherein the at least one connector comprises a magnet.

15. A prosthetic heart valve for implantation in a biological annulus, the prosthetic heart valve comprising:

an expandable sealing member comprising an annular ring and a sewing cuff extending from the annular ring, a fabric covering, and a baleen element, wherein fabric covering covers at least a portion of the baleen element, wherein in a contracted state, the baleen element is compressed against the annular member and in an expanded state, an angle between the annular member and the baleen element increases and an angle between the sewing cuff and the baleen element decreases such that the baleen element billows at least a portion of the fabric covering outwardly away from the annular ring as the sealing member transitions from the contracted state to the expanded state within the biological annulus;

wherein the baleen element is positioned exterior with respect to the annular ring in both the contracted and expanded states; and

a valve member attached to the expandable sealing member.

16. The prosthetic heart valve of claim 15, further comprising at least one connector for attaching the valve member to the expandable sealing member.

17. The prosthetic heart valve of claim 15, wherein the fabric covering also covers at least a portion of the annular ring.

18. The prosthetic heart valve of claim 15, wherein the baleen element comprises a plurality of finger elements for billowing at least a portion of the fabric covering outwardly away from the annular ring.