Rapid deployment prosthetic heart valve

• US 20060287719A1
• Filed: 05/24/2006
• Published: 12/21/2006
• Est. Priority Date: 05/24/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Keidar, Yaron, Benichou, Netanel, Wood, Larry, Spenser, Benjamin, Rowe, Stanton J., Bourang, Henry, Bash, Assaf, Bakis, George
• Granted Patent: US 8,500,798 B2
• Time in Patent Office: Days
• US Class Current: 623/2.180
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves

Abstract

A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment.

Claims

1. A two-stage prosthetic heart valve, comprising:

an expandable anchoring member sized to contact a heart valve annulus in an expanded state; and

a non-expandable valve member configured for connection to the anchoring member.

2. The heart valve of claim 1, wherein the valve member includes a base ring surrounding an inflow end thereof, and the anchoring member comprises a tubular structure having connectors adapted to engage the base ring.

3. The heart valve of claim 2, wherein the connectors comprise prongs that change shape and engage the base ring.

4. The heart valve of claim 3, wherein the base ring is made of a suture-permeable material, and the prongs are configured to pierce the base ring.

5. The heart valve of claim 3, wherein the prongs are shaped to wrap around the base ring.

6. The heart valve of claim 1, wherein the valve member includes a plurality of discrete connectors spaced around a peripheral inflow end thereof, and the anchoring member comprises a tubular structure having a plurality of mating connectors spaced around a peripheral outflow end thereof, the connectors on the valve member and anchoring member being configured to engage one another by displacing the valve member toward the anchoring member.

7. The heart valve of claim 6, wherein the connectors on either the valve member or anchoring member comprise latches, and the connectors on the other of the valve member or anchoring member comprise brackets, the latches being configured to engage and lock to the brackets upon axial movement of the latches and brackets toward one another.

8. The heart valve of claim 6, further including a plurality of guide filaments, at least one for each of the connectors on the anchoring member and slidingly received by the associated connector on the valve member for guiding the valve member in proper orientation with respect to the anchoring member to ensure engagement of the mating connectors.

9. The heart valve of claim 1, wherein the anchoring member comprises a stent having a wider outflow end than an inflow end, and wherein the valve member comprises a base ring surrounding an inflow end thereof, the base ring being sized to fit within the outflow end of the stent.

10. The heart valve of claim 1, wherein the valve member includes a suture-permeable base ring surrounding an inflow end thereof, and the anchoring member comprises a tubular structure having a suture-permeable fixation ring attached thereto, wherein the valve member connects to the anchoring member via sutures looped between the base ring and the fixation ring.

11. A two-stage prosthetic heart valve, comprising:

an expandable anchoring member sized to contact a heart valve annulus in an expanded state;

a valve member; and

.

an adapter sized to surround the valve member and engage the anchoring member for connecting the valve member to the anchoring member.

12. The heart valve of claim 11, wherein the adapter comprises an annular ring.

13. The heart valve of claim 11, wherein the valve member comprises flexible leaflets and a plurality of alternating cusps and upstanding commissures, and the adapter comprises a wireform-shaped member that closely surrounds and conforms to the cusps and commissures of the valve member.

14. The heart valve of claim 11, wherein the adapter includes a plurality of discrete connectors, and the anchoring member comprises a tubular structure having a plurality of mating connectors spaced around a peripheral outflow end thereof, the connectors on the adapter and anchoring member being configured to engage one another by displacing the adapter toward the anchoring member.

15. The heart valve of claim 14, wherein the valve member includes a base ring surrounding an inflow end thereof, and the adapter further includes a plurality of connectors adapted to engage and couple the adapter directly to the base ring.

16. The heart valve of claim 14, wherein the connectors on either the adapter or anchoring member comprise latches, and the connectors on the other of the adapter or anchoring member comprise brackets, the latches being configured to engage and lock to the brackets upon axial movement of the latches and brackets toward one another.

17. The heart valve of claim 14, further including a plurality of guide members, at least one for each of the connectors on the anchoring member and slidingly received by the associated connector on the adapter for guiding the adapter in proper orientation with respect to the anchoring member to ensure engagement of the mating connectors.

18. A system for retrofitting a conventional prosthetic heart valve, comprising:

an off-the-shelf, non-expandable prosthetic heart valve having a sewing ring capable of being implanted using sutures through the sewing ring in an open-heart procedure;

an expandable anchoring member sized to contact and anchor to a heart valve annulus in an expanded state; and

coupling means for connecting the prosthetic heart valve to the anchoring member, the prosthetic heart valve thus being attached to the heart valve annulus via the anchoring member.

19. The system of claim 18, wherein the anchoring member comprises a tubular structure having a suture-permeable fixation ring attached thereto, wherein the coupling means comprises sutures looped between the base ring and the fixation ring.

20. The system of claim 18, further including an adapter sized to surround the heart valve and engage the anchoring member, to connect the heart valve and anchoring member.

21. The heart valve of claim 20, wherein the adapter is selected from the group consisting of:

an annular ring; and

a wireform-shaped member.

22. The heart valve of claim 20, wherein the adapter includes a plurality of discrete connectors, and the anchoring member comprises a tubular structure having a plurality of mating connectors spaced around a peripheral outflow end thereof, the connectors on the adapter and anchoring member being configured to engage one another by displacing the adapter toward the anchoring member.

23. The heart valve of claim 20, wherein the adapter further includes a plurality of connectors adapted to engage and couple the adapter directly to the sewing ring.