Transcatheter heart valve prostheses

• US 8,070,800 B2
• Filed: 05/03/2007
• Issued: 12/06/2011
• Est. Priority Date: 05/05/2006
• Status: Active Grant

• Current Assignee: Children's Medical Center Corporation
• Original Assignee: Children's Medical Center Corporation
• Inventors: Lock, James E., McElhinney, Doff B.
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US12/299,746
• Publication Number:
  US 20090222082A1
• Time in Patent Office: 1,678 Days
• Field of Search: 623 124- 126, 623 211- 219, 623/1.11, 606/108, 606/191, 606/194, 606/200
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61F 2250/006 modular

Abstract

The present teachings relate to a heart valve prosthesis. The heart valve prosthesis includes a docking station (77) having a wire frame defining a lumen and a valve frame (91) for positioning within its lumen. The docking station includes a diaphragm (78) adapted to have an open position and a closed position, which provides a temporary control mechanism for preventing free regurgitation during the time period between the deployment of the docking station and the deployment of the valve frame, and a sealing mechanism for preventing paravalvar leakage.

Claims

1. A heart valve prosthesis comprising a docking station and a replacement heart valve, wherein:

the docking station comprises

a wire frame defining a lumen, and

a diaphragm positioned within the lumen and attached to the wire frame of the docking station prior to deployment, wherein the diaphragm is thinner and has less structural integrity than the replacement heart valve, and is adapted to have an open position and a closed position, and

the replacement heart valve comprises a valve frame for positioning within the lumen of the docking station, wherein the valve frame of the replacement heart valve comprises a substantially cylindrical body defining a lumen and a plurality of valve members attached to the substantially cylindrical body, and each of the valve members comprises one or more curved wires and a leaflet.

2. The heart valve prosthesis of claim 1, wherein the docking station is self-expandable.

3. The heart valve prosthesis of claim 1, wherein the docking station is balloon-expandable.

4. The heart valve prosthesis of claim 1, wherein the wire frame of the docking station comprises one or more openings.

5. The heart valve prosthesis of claim 1 comprising a radiopaque marker on the wire frame of the docking station.

6. The heart valve prosthesis of claim 1, wherein the diaphragm comprises a biocompatible membrane.

7. The heart valve prosthesis of claim 1, wherein the diaphragm comprises one or more slits.

8. The heart valve prosthesis of claim 1, wherein the diaphragm comprises a plurality of leaflets.

9. The heart valve prosthesis of claim 8, wherein the leaflets of the diaphragm are supported by one or more wires.

10. The heart valve prosthesis of claim 1, wherein the diaphragm comprises one or more perforations.

11. The heart valve prosthesis of claim 1, wherein the diaphragm is attached to the wire frame of the docking station by sutures.

12. The heart valve prosthesis of claim 1, wherein the diaphragm is attached to the wire frame of the docking station by adhesives.

13. The heart valve prosthesis of claim 1, wherein the wire frame of the docking station comprises a cylindrical portion and a bulbous portion, the diaphragm being attached to the bulbous portion of the wire frame.

14. The heart valve prosthesis of claim 1, wherein the one or more curved wires of each of the valve members of the replacement heart valve comprises an inner curved wire support structure and an outer curved wire support structure.

15. The heart valve prosthesis of claim 14, wherein the leaflet of each of the valve members of the replacement heart valve comprises a leaflet body and one or more leaflet projections.

16. The heart valve prosthesis of claim 15, wherein the one or more leaflet projections are attached to a respective inner curved support structure and the leaflet body extends over a respective outer curved support structure, so as to position the leaflet body within the lumen of the valve frame of the replacement heart valve.

17. A method of delivering the heart valve prosthesis of claim 1 to an anatomical site, the method comprising the steps of:

introducing the docking station into a heart through a catheter

deploying the docking station;

introducing the replacement heart valve into the lumen of the docking station through a catheter; and

deploying the replacement heart valve within the lumen of the docking station so that the diaphragm is forced into the open position and leaflets of the diaphragm are pressed between the wire frame of the docking station and the valve members of the replacement heart valve.

18. The method of claim 17 further comprising determining a diameter of the deployed docking station using fluoroscopy.

19. The method of claim 18, wherein the replacement heart valve has a diameter that approximates the diameter of the deployed docking station.