Prosethetic Haert Valves, Scaffolding Structures, and Systems and Methods for Implantation of Same

• US 20120095549A1
• Filed: 12/21/2011
• Published: 04/19/2012
• Est. Priority Date: 02/27/2004
• Status: Active Grant

• Current Assignee: AorTx, Inc. (Johnson & Johnson)
• Original Assignee: AorTx, Inc. (Johnson & Johnson)
• Inventors: Forster, David C., Heneveld, Scott, Walsh, Brandon G.
• Granted Patent: US 9,168,134 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• 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 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

Prosthetic valves and their component parts are described, as are prosthetic valve delivery devices and methods for their use. The prosthetic valves are particularly adapted for use in percutaneous aortic valve replacement procedures. The delivery devices are particularly adapted for use in minimally invasive surgical procedures.

Claims

1. A method for delivering a prosthetic heart valve, comprising:

advancing a prosthetic heart valve through the vasculature of a patient to a treatment site along a wall of a blood vessel, the prosthetic heart valve comprising (i) a tubular support structure comprising a plurality of independently expandable segments oriented along the periphery of the support structure, and (ii) a plurality of valve leaflets coupled with the plurality of segments;

expanding an expansion member within the tubular support structure such that the tubular support structure expands and contacts the vessel wall, wherein the blood vessel is not occluded after the expansion member is expanded.

2. The method of claim 1, wherein the expansion member comprises a plurality of expandable elements.

3. The method of claim 2, wherein expanding the expansion member comprises expanding a first one of the plurality of expandable elements.

4. The method of claim 3, further comprising expanding a second one of the expandable elements after expanding the first one of the expandable elements.

5. The method of claim 4, wherein the tubular support structure comprises exactly three expandable segments, each being coupled together by a hinge, and wherein the expansion member comprises exactly three expandable elements.

6. The method of claim 5, wherein the expandable elements are balloons.

7. The method of claim 2, wherein expanding the expansion member comprises expanding each of the plurality of expandable elements together.

8. The method of claim 4, wherein the tubular support structure comprises exactly three expandable segments, each being coupled together by a hinge, and wherein the expansion member comprises exactly three expandable elements.

9. The method of claim 2, wherein, when each of the plurality of expandable elements is expanded, blood is free to flow through the prosthetic heart valve between the expandable elements.

10. The method of claim 2, wherein the expandable member is configured to allow each of the expandable elements to be separately expandable and to be expanded together to obtain different force distributions.

11. The method of claim 1, wherein the prosthetic heart valve is advanced through the vasculature by a delivery catheter that further comprises the expansion member.

12. The method of claim 11, wherein the delivery catheter is coupled to a proximal handle configured to control the delivery of the prosthetic valve and to cause expansion of the expandable member.

13. The method of claim 1, wherein the prosthetic heart valve is advanced through the vasculature by a delivery catheter separate from a carrier that carries the expansion member.

14. The method of claim 1, further comprising advancing the expansion member into the tubular support structure prior to expanding the expansion member.

15. The method of claim 1, further comprising retracting the expansion member into the tubular support structure prior to expanding the expansion member.

16. The method of claim 1, wherein the tubular support structure is configured to self-expand and the expansion of the expansion member provides additional expansion force to the self-expandable tubular support structure.

17. The method of claim 1, further comprising self-expanding the tubular support structure prior to expanding the expansion member.

18. The method of claim 1, wherein the expansion member comprises (i) a plurality of expandable elements, each being oriented about a centrally located longitudinal axis, and (ii) a central lumen configured to allow passage of a guidewire through the expansion member.

19. The method of claim 17, wherein each of the expandable elements is a balloon coupled with a separate feeder lumen for passage of an inflation medium.

20. The method of claim 18, wherein each of the expandable elements has a distal end attached to a flexible member having a guidewire lumen.