Transcatheter delivery of a replacement heart valve

• US 7,470,285 B2
• Filed: 02/07/2005
• Issued: 12/30/2008
• Est. Priority Date: 02/05/2004
• Status: Active Grant

• Current Assignee: Children's Medical Center Corporation
• Original Assignee: Children's Medical Center Corporation
• Inventors: Lock, James E., Nugent, Alan
• Primary Examiner(s): Matthews; William H
• Application Number:
  US11/052,466
• Publication Number:
  US 20050234546A1
• Time in Patent Office: 1,422 Days
• Field of Search: 623/2.17, 623/2.18, 623/2.22, 623/2.23
• US Class Current: 623/2.18
• 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. A replacement heart valve apparatus comprising:

a body defining a lumen;

a plurality of curved wire pairs attached to the body, each curved wire pair comprising an inner curved wire and an outer curved wire, wherein the outer curved wire extends substantially parallel to the inner curved wire; and

a plurality of leaflets, each leaflet comprising a leaflet body and one or more leaflet projections, wherein each leaflet is positioned such that

the leaflet body is located within the lumen of the body,

the portion of the leaflet body nearest the one or more leaflet projections is pulled away from the lumen of the body 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 of the body and curved over the respective inner curved wire, and

each of the one or more leaflet projections is attached to itself.

2. The replacement heart valve apparatus of claim 1 wherein the inner curved wire and the outer curved wire are parabolic in curvature.

3. The replacement heart valve apparatus of claim 1 wherein one end of the body has a serpentine edge, and wherein each end of the inner curved wire and the outer curved wire is attached to a vertex of the serpentine edge.

4. The replacement heart valve apparatus of claim 1 further comprising one or more radiopaque markers at each end of the body.

5. The replacement heart valve apparatus of claim 1 wherein the body defining a lumen is a substantially cylindrical body.

6. The replacement heart valve apparatus of claim 1 wherein the body defining a lumen has a shape approximating a barrel.

7. The replacement heart valve apparatus of claim 1 wherein the body defining a lumen comprises a plurality of serpentine curved wires.

8. The replacement heart valve apparatus of claim 1 comprising three curved wire pairs and a leaflet attached to each of the three curved wire pairs.

9. The replacement heart valve apparatus of claim 1 wherein each of the one or more leaflet projections is attached to itself by sutures.

10. A replacement heart valve apparatus comprising:

a body defining a lumen;

a plurality of curved wire pairs attached to the body, each curved wire pair comprising an inner curved wire and an outer curved wire, wherein the inner curved wire and the outer curved wire are separate from each other by a space that is substantially constant; and

a plurality of leaflets, each leaflet comprising a leaflet body and one or more leaflet projections, wherein each leaflet is positioned such that

the leaflet body is located within the lumen of the body,

the portion of the leaflet body nearest the one or more leaflet projections is pulled away from the lumen of the body 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 of the body and-curved over the respective inner curved wire, and

each of the one or more leaflet projections is attached to itself.

11. The replacement heart valve apparatus of claim 10 wherein the inner curved wire and the outer curved wire are parabolic in curvature.

12. The replacement heart valve apparatus of claim 10 wherein one end of the body has a serpentine edge, and 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.

13. The replacement heart valve apparatus of claim 10 further comprising one or more radiopaque markers at each end of the body.

14. The replacement heart valve apparatus of claim 10 wherein the body defining a lumen is a substantially cylindrical body.

15. The replacement heart valve apparatus of claim 10 wherein the body defining a lumen has a shape approximating a barrel.

16. The replacement heart valve apparatus of claim 10 wherein the body defining a lumen comprises a plurality of serpentine curved wires.

17. The replacement heart valve apparatus of claim 10 comprising three curved wire pairs and a leaflet attached to each of the three curved wire pairs.

18. The replacement heart valve apparatus of claim 10 wherein each of the one or more leaflet projections is attached to itself by sutures.

19. A replacement heart valve apparatus comprising:

a body defining a lumen, wherein one end of the body has a serpentine edge;

a plurality of curved wire pairs attached to the body, each curved wire pair comprising an inner curved wire and an outer curved wire,

wherein the outer curved wire extends substantially parallel to the inner curved wire, 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 of the body 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; and

a plurality of leaflets, each leaflet comprising a leaflet body and one or more leaflet projections, wherein the one or more leaflet projections are curved over a respective inner wire and attached to itself, and the leaflet body extends over a respective outer curved wire.

20. The replacement heart valve apparatus of claim 19 further comprising one or more radiopaque markers at each end of the body.

21. The replacement heart valve apparatus of claim 19 wherein the body defining a lumen is a substantially cylindrical body.

22. The replacement heart valve apparatus of claim 19 wherein the body defining a lumen has a shape approximating a barrel.

23. The replacement heart valve apparatus of claim 19 comprising three curved wire pairs and a leaflet attached to each of the three curved wire pairs.

24. A replacement heart valve apparatus comprising:

a body defining a lumen, wherein one end of the body has a serpentine edge;

a plurality of curved wire pairs attached to the body, each curved wire pair comprising an inner curved wire and an outer curved wire,

wherein the inner curved wire and the outer curved wire are separate from each other by a space that is substantially constant, each end of the inner curved wire is attached to a trough of the serpentine edge, and each end of the outer curved wire is attached to a vertex of the serpentine edge,

wherein the serpentine edge of the body 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; and

a plurality of leaflets, each leaflet comprising a leaflet body and one or more leaflet projections, wherein the one or more leaflet projections are curved over a respective inner wire and attached to itself, and the leaflet body extends over a respective outer curved wire.

25. The replacement heart valve apparatus of claim 24 further comprising one or more radiopaque markers at each end of the body.

26. The replacement heart valve apparatus of claim 24 wherein the body defining a lumen is a substantially cylindrical body.

27. The replacement heart valve apparatus of claim 24 wherein the body defining a lumen has a shape approximating a barrel.

28. The replacement heart valve apparatus of claim 24 comprising three curved wire pairs and a leaflet attached to each of the three curved wire pairs.