Heart valve assembly with slidable coupling connections

• US 7,597,711 B2
• Filed: 01/26/2004
• Issued: 10/06/2009
• Est. Priority Date: 01/26/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Arbor Surgical Technologies, Inc. (Medtronic Plc)
• Inventors: Drews, Michael J., Gurskis, Donnell W., Bacich, Steven R.
• Primary Examiner(s): Pellegrino; Brian E.
• Application Number:
  US10/765,725
• Publication Number:
  US 20050165479A1
• Time in Patent Office: 2,080 Days
• Field of Search: 623/2.38, 623/2.4, 623/2.41, 623 212- 216, 623/2.39, 623/2.35, 623/2.11, 606/151, 606/153, 606/232
• US Class Current: 623/2.11
• 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 2250/006 modular
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A heart valve assembly includes a base including a multi-lobular annular shape within a plane, a valve member or other annular body including a multi-lobular shape complementary to the shape of the base, and cooperating connectors on the base and the annular body for connecting the annular body to the base. The base includes an anchoring ring, and a flexible cuff for attaching the base to a biological annulus. The base and the annular body include guides for aligning their multi-lobular shapes, e.g., visual, tactile, or other markers, or tethers that extend from the base that are slidable through the annular body. During use, the base is attached to a biological annulus, the annular body is directed adjacent the annulus, oriented such that the multi-lobular shape of the annular body valve member is aligned with the base, and the annular body is attached to the base.

Claims

1. A heart valve assembly, comprising:

a base member comprising a generally annular shaped body and a flexible cuff extending around a periphery of the annular shaped body;

a valve member separate from the base member and comprising an annular frame having a multi-lobular shape;

one or more elongate guide members extending upwardly beyond and away from the base member and receivable through the valve member such that the valve member is slidable along the one or more guide members to align the valve member with the base member as the valve member is directed towards the base member; and

cooperating connectors for securing the valve member adjacent the base member, the cooperating connectors comprising one or more elements on each of the one or more guide members for engaging the valve member to allow the valve member to be directed towards the base member but preventing the valve member from being directed away from the base member.

2. The assembly of claim 1, wherein the valve member comprises a plurality of leaflets extending from the frame.

3. The assembly of claim 1, wherein the flexible cuff extends radially from the annular shaped body.

4. The assembly of claim 1, wherein the base member defines a plane and a longitudinal axis substantially orthogonal to the plane, the base member comprising a multi-lobular annular shape within the plane, and wherein the multi-lobular shape of the valve member is complementary to the multi-lobular shape of the base member.

5. The assembly of claim 4, further comprising one or more additional guides on at least one of the base member and the annular body for aligning the multi-lobular shapes with one another about the longitudinal axis.

6. The assembly of claim 1, wherein the valve member comprises one or more guide channels for receiving a respective one of the one or more guide members therethrough.

7. The assembly of claim 6, wherein each guide channel comprises a piece of material attached to the valve member.

8. The assembly of claim 6, wherein each guide channel comprises a recess in the valve member.

9. The assembly of claim 8, wherein each guide channel further comprises a cover extending across at least a portion of the recess.

10. The assembly of claim 1, wherein the one or more guide members comprise a rectangular cross-section.

11. The assembly of claim 1, wherein the one or more guide members are detachable from the base member.

12. A heart valve assembly, comprising:

a base member comprising a generally annular shaped body and a flexible cuff extending around a periphery of the annular shaped body;

a valve member separate from the base member and comprising an annular frame having a multi-lobular shape;

one or more elongate guide members extending upwardly beyond and away from the base member and receivable through the valve member such that the valve member is slidable along the one or more guide members to align the valve member with the base member as the valve member is directed towards the base member; and

cooperating connectors for securing the valve member adjacent the base member,

wherein the cooperating connectors comprise one or more ratcheting elements on each of the one or more guide members, thereby providing at least one of a tactile indication and an audible indication as the valve member is directed towards the base member.

13. A heart valve assembly, comprising:

a base member comprising a generally annular shaped body and a flexible cuff extending around a periphery of the annular shaped body;

a valve member separate from the base member and comprising an annular frame having a multi-lobular shape; and

one or more elongate guide members extending upwardly beyond and away from the base member and receivable through the valve member such that the valve member is slidable along the one or more guide members to align the valve member with the base member as the valve member is directed towards the base member,

each of the one or more guide members comprising one or more elements spaced a predetermined distance apart from the base member, each element comprising sloping proximal surfaces and blunt distal surfaces, allowing the valve member to be directed down the guide members until disposed the predetermined distance from the base member, but preventing the valve member from subsequently being directed away from the base member.

14. The assembly of claim 13, wherein the one or more elements comprise one or more detents.

15. A heart valve assembly, comprising:

a base member comprising a generally annular shaped body, the base member comprising an annular ring and a flexible cuff extending around a periphery of the annular ring;

a valve member separate from the base member and comprising a multi-lobular shape;

a plurality of elongate guide members spaced apart around a periphery of the base member and extending upwardly beyond and away from the base member, the elongate guide members having a length such that the elongate guide members extend from a biological annulus when the base member is introduced into the biological annulus;

a plurality of guide channels in the valve member for receiving respective guide members therethrough such that the valve member is slidable along the guide members from outside the biological annulus to align the valve member with the base member as the valve member is directed into the biological annulus towards the base member; and

cooperating connectors for securing the valve member adjacent the base member, the cooperating connectors comprising one or more elements on each of the guide members for engaging the guide channels to allow the valve member to be directed towards the base member but preventing the valve member from being directed away from the base member.

16. The assembly of claim 15, wherein the cooperating connectors comprise the guide channels on the valve member and connectors on the guide members for engaging the guide channels for securing the valve member adjacent the base member.

17. The assembly of claim 15, wherein the base member comprises a multi-lobular shape, and wherein the guide members extend from respective lobes of the base member.

18. The assembly of claim 15, the guide members being detachable from the base member.

19. The assembly of claim 15, further comprising one or more additional guides on at least one of the base member and the valve member for aligning the valve member with the base member about the longitudinal axis before the elongate guide members are introduced through the guide channels.

20. The assembly of claim 19, wherein the one or more additional guides comprise visual markers on at least one of the base member and the valve member.

21. A heart valve assembly, comprising:

a base member comprising a generally annular shaped body, the base member comprising an annular ring and a flexible cuff extending around a periphery of the annular ring;

a valve member separate from the base member and comprising a multi-lobular shape;

a plurality of elongate guide members spaced apart around a periphery of the base member and extending upwardly beyond and away from the base member, the elongate guide members having a length such that the elongate guide members extend from a biological annulus when the base member is introduced into the biological annulus;

a plurality of guide channels in the valve member for receiving respective guide members therethrough such that the valve member is slidable along the guide members from outside the biological annulus to align the valve member with the base member as the valve member is directed into the biological annulus towards the base member; and

cooperating connectors for securing the valve member adjacent the base member,

wherein the cooperating connectors comprise one or more ratcheting elements on each of the guide members, thereby providing at least one of a tactile indication and an audible indication as the valve member is directed towards the base member.