Transcatheter Delivery of a Replacement Heart Valve

• US 20090082858A1
• Filed: 12/03/2008
• Published: 03/26/2009
• Est. Priority Date: 02/05/2004
• Status: Active Grant

• Current Assignee: Children's Medical Center Corporation
• Original Assignee: Children's Medical Center Corporation
• Inventors: Nugent, Alan, Lock, James E.
• Granted Patent: US 8,092,524 B2
• Time in Patent Office: Days
• US Class Current: 623/2.180
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0002 for data transfer
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

A replacement heart valve apparatus. The heart valve apparatus includes a stent and a valve frame having a substantially cylindrical body defining a lumen. The valve frame includes a plurality of curved wire pairs attached to the substantially cylindrical body. Each curved wire pair includes an inner curved wire and an outer curved wire. The wire frame further having a plurality of leaflets. Each leaflet is attached to a respective inner curved wire and extends over a respective outer curved wire, so as to position the body of the leaflet within the lumen of the valve frame.

Claims

1-7. -7. (canceled)

8. A replacement heart valve comprising:

a valve frame comprising a body defining a lumen, wherein the body of the valve frame comprises;

a substantially cylindrical body portion, wherein one end of the substantially cylindrical body portion comprises a serpentine edge;

one or more exterior serpentine rings at a distance away from the substantially cylindrical body portion;

a plurality of valve attachment wires between the one or more exterior serpentine rings and the substantially cylindrical body portion; and

a plurality of standoff wires attached to the one or more exterior serpentine rings and the substantially cylindrical body portion.

9. The replacement heart valve of claim 8, wherein the plurality of valve attachment wires comprise a plurality of curved wire pairs, and each curved wire pair comprises an inner curved wire and an outer curved wire.

10. The replacement heart valve of claim 9, wherein the inner curved wire and the outer curved wire are separate from each other by a space that is substantially constant.

11. The replacement heart valve of claim 9, wherein the inner curved wire and the outer curved wire are parabolic in curvature.

12. The replacement heart valve of claim 9, wherein each end of the inner curved wire and the outer curved wire is attached to a vertex of the serpentine edge.

13. The replacement heart valve of claim 9, wherein each end of the inner curved wire is attached to a vertex of the serpentine edge, and each end of the outer curved wire is attached to a trough of the serpentine edge, wherein the serpentine edge is constructed and arranged such that, in use, each vertex points to a direction opposite blood flow, and each trough points to the direction of blood flow.

14. The replacement heart valve of claim 9, wherein the inner curved wire and the outer curved wire of a curved wire pair each comprises a first end attached to a first standoff wire and a second end attached to a second standoff wire.

15. The replacement heart valve of claim 8, comprising a plurality of valve leaflets attached to the valve attachment wires.

16. The replacement heart valve of claim 9, comprising a plurality of valve leaflets, each leaflet comprising a leaflet body and one or more leaflet projections, wherein the one or more leaflet projections are curved around a respective inner wire and attached to itself, and the leaflet body extends over a respective outer curved wire.

17. The replacement heart valve of claim 16, wherein each leaflet is positioned such that the leaflet body is located within the lumen of the valve frame, the portion of the leaflet body nearest the one or more leaflet projections is pulled away from the lumen over a respective outer curved wire and toward a respective inner curved wire to position the one or more leaflet projections such that they are extended toward the lumen and curved around the respective inner curved wire.

18. The replacement heart valve of claim 8, comprising one or more radiopaque markers at the one or more exterior serpentine rings.

19. The replacement heart valve of claim 8, comprising one or more radiopaque markers at the substantially cylindrical body portion.

20. A method of delivering a replacement heart valve into an anatomical lumen, the method comprising:

introducing a docking station into an anatomical lumen through a catheter;

introducing the replacement heart valve of claim 8 into the docking station through a catheter;

positioning the replacement heart valve within the docking station; and

releasing the replacement heart valve within the docking station.

21. The method of claim 20, comprising expanding and securing the docking station within the anatomical lumen before introducing the replacement heart valve within the docking station.

22. The method of claim 20, comprising attaching one or more valve leaflets to the valve attachment wires before introducing the replacement heart valve within the docking station.

23. The method of claim 20, comprising determining the position of the replacement heart valve within the docking station using fluoroscopy.

24. The method of claim 20, comprising partially deploying the replacement heart valve within the docking station;

determining the position of the replacement heart valve within the docking station using fluoroscopy; and

retracting and redeploying the replacement heart valve within the docking station in response to the determination of position of the replacement heart valve.