Methods for rapid deployment of prosthetic heart valves

• US 7,708,775 B2
• Filed: 05/24/2006
• Issued: 05/04/2010
• Est. Priority Date: 05/24/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Benichou, Netanel, Wood, Larry, Spenser, Benjamin, Bourang, Henry, Bash, Assaf, Bakis, George, Rowe, Stanton J., Keidar, Yaron
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen T.
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US11/441,405
• Publication Number:
  US 20060287717A1
• Time in Patent Office: 1,441 Days
• Field of Search: 623/1.11, 623 21- 242
• 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 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 surgical method of implanting a prosthetic heart valve in a patient, comprising:

providing a two-stage prosthetic heart valve comprising an expandable anchoring member and a valve member, the anchoring member being sized to contact a heart valve annulus in an expanded state and the valve member being configured to connect to the anchoring member, the anchoring member having opposed ends and the valve member having a plurality of commissure posts axially extending to tips and supporting flexible leaflets therebetween;

preparing the patient for surgery by placing him/her on cardiopulmonary bypass;

creating a direct access pathway to the heart valve annulus that permits direct naked eye vision of the heart valve annulus;

delivering and expanding the anchoring member to contact the heart valve annulus; and

delivering and connecting the valve member at a first end of the anchoring member such that the commissure post tips are located outside of the anchoring member by attaching members between the first end of the anchoring member and over the tips of the commissure posts of the valve member.

2. The method of claim 1, wherein the step of creating a direct access pathway comprises performing open-heart surgery.

3. The method of claim 1, wherein the step of delivering and expanding the anchoring member comprises balloon-expanding the anchoring member.

4. The method of claim 1, wherein the valve member is expandable, and the step of delivering and connecting the valve member comprises delivering the valve member in a compressed state and expanding it prior to connecting it to the anchoring member.

5. The method of claim 1, wherein the valve member and the anchoring member are further provided with mating connectors, and the step of delivering and connecting the valve member to the anchoring member comprises axially displacing the valve member toward the anchoring member so that the mating connectors engage.

6. The method of claim 1, wherein the anchoring member comprises a stent having an outflow end larger than an inflow end thereof, and wherein the valve member comprises a non-expandable valve member having a base ring on an inflow end thereof sized to fit within the outflow end of the stent, wherein the step of delivering and connecting the valve member to the anchoring member comprises positioning the valve member within the outflow end of the stent.

7. The method of claim 1, wherein the members attaching the first end of the anchoring member to the commissure posts of the valve member include bendable connectors on an outflow end thereof, and the method includes causing the connectors to bend inward and engage the tips of the commissure posts.

8. The method claim 7, wherein the step of causing the connectors to bend inward comprises actuating a bending tool that is removed from the implantation site thereafter.

17. The method of claim 1, wherein the members attaching the first end of the anchoring member to the commissure posts of the valve member are configured to change shape from a first configuration to a second configuration that wraps over the tips of the commissure posts.

18. The method of claim 17, wherein the members are formed of a malleable material, and the step of connecting the prosthetic heart valve to the anchoring member includes bending the members from the first configuration to the second configuration.

19. The method of claim 17, wherein the members are hinged and can be pivoted from the first configuration to the second configuration, and the step of connecting the prosthetic heart valve to the anchoring member includes pivoting the members from the first configuration to the second configuration.

20. The method of claim 17, wherein the members are formed of a shape memory material that curls from the first configuration to the second configuration upon being implanted in the body.

9. A surgical method of implanting a two-stage prosthetic heart valve in a patient, comprising:

providing an expandable anchoring member sized to contact a heart valve annulus in an expanded state, the anchoring member having opposed ends;

delivering and attaching the anchoring member to the heart valve annulus;

providing a non-expandable valve member having a plurality of commissure posts axially extending to tips and supporting flexible leaflets therebetween; and

delivering and connecting the valve member at a first end of the anchoring member such that the commissure post tips are located outside of the anchoring member by attaching members between the first end of the anchoring member and over the tips of the commissure posts.

10. The method of claim 9, wherein the valve member and the anchoring member are provided with mating connectors, and the step of delivering and connecting the valve member to the anchoring member comprises axially displacing the valve member toward the anchoring member so that the mating connectors engage.

11. The method of claim 9, wherein the anchoring member comprises a stent having an outflow end larger than an inflow end thereof, and wherein the valve member comprises a base ring on an inflow end thereof sized to fit within the outflow end of the stent, wherein the step of delivering and connecting the valve member to the anchoring member comprises positioning the valve member within the outflow end of the stent.

12. The method of claim 9, wherein the members attaching the first end of the anchoring member to the commissure posts of the valve member include bendable connectors on an outflow end thereof, and the method includes causing the connectors to bend inward and engage the tips of the commissure posts.

13. The method claim 12, wherein the step of causing the connectors to bend inward comprises actuating a bending tool that is removed from the implantation site thereafter.

14. The method of claim 9, wherein the valve member includes a base ring on an inflow end thereof, and the method further includes providing an adapter sized to surround the valve member and seat on the base ring, the step of delivering and connecting the valve member comprises coupling the adapter to the anchoring member.

15. The method of claim 14, 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 step of coupling the adapter to the anchoring member comprises displacing the adapter toward the anchoring member to engage the mating connectors thereon.

16. The heart valve of claim 14, wherein the adapter further includes a plurality of connectors adapted to engage and couple the adapter directly to the base ring, and the method includes causing the connectors to engage the base ring.

21. The method of claim 9, wherein the members attaching the first end of the anchoring member to the commissure posts of the valve member are hinged and can be pivoted from the first configuration to the second configuration, and the step of connecting the prosthetic heart valve to the anchoring member includes pivoting the members from the first configuration to the second configuration.

22. The method of claim 9, wherein the members attaching the first end of the anchoring member to the commissure posts of the valve member are formed of a shape memory material that curls from the first configuration to the second configuration upon being implanted in the body.