Prosthetic valve with slanted leaflet design

• US 7,678,144 B2
• Filed: 01/25/2008
• Issued: 03/16/2010
• Est. Priority Date: 01/29/2007
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Case, Brian C., Bailey, Frances Kristen, Paul, Ram H. Jr.
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US12/019,987
• Publication Number:
  US 20080183279A1
• Time in Patent Office: 781 Days
• Field of Search: 623/1.24, 623/1.26, 623 212- 233, 623/23.68
• US Class Current: 623/2.16
• 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 2/2421 with non-pivoting rigid closure members
• CPC Class Codes: A61F 2/2475 Venous valves

Abstract

The invention relates to a prosthetic valve for regulating fluid flow through a body lumen. The valve includes a frame and a valve member comprising at least one semi-rigid leaflet and at least one flexible leaflet. The at least one semi-rigid leaflet comprises a first portion and a second portion, the first portion attached to the frame and the second portion free of the frame. The at least one semi-rigid leaflet is slanted in a retrograde direction from the second portion to the first portion. The at least one flexible leaflet comprises a first portion and a second portion, the first portion attached to the frame and the second portion free of the frame. The at least one flexible leaflet is slanted in a retrograde direction from the first portion to the second portion when at rest.

Claims

1. A valve prosthesis for implantation within a body lumen comprising a frame and at least one valve member comprising at least one semi-rigid leaflet and at least one flexible leaflet;

the at least one semi-rigid leaflet comprising a first portion operatively coupled to the frame and a second portion being free of the frame, the at least one semi-rigid leaflet slanted in a retrograde direction from the second portion to the first portion;

the at least one flexible leaflet comprising a first portion operatively coupled to the frame and a second portion being free of the frame, the at least one flexible leaflet slanted in a retrograde direction from the first portion to the second portion when at rest;

the at least one flexible leaflet being moveable between a first position that permits fluid flow in a first direction and a second position in which the at least one flexible leaflet second portion coapts with the at least one semi-rigid leaflet second portion thus substantially preventing fluid flow in a second, retrograde direction.

2. The prosthesis of claim 1, where the flexible leaflet and semi-rigid leaflet comprise a material selected from the group consisting of biocompatible polyurethane, extracellular matrix material, xenogenic biomaterials, autologous tissue, and allogeneic tissue.

3. The prosthesis of claim 1, where the semi-rigid leaflet comprises a material different from the flexible leaflet.

4. The prosthesis of claim 3, where the semi-rigid leaflet further comprises a reinforcing material selected from the group consisting of threads, fibers, meshes, and wires.

5. The prosthesis of claim 4, where the fibers comprise electrospun nanofibers.

6. The prosthesis of claim 1, where the flexible leaflet comprises a surface having a curvature approximate to a curvature of the body vessel wall.

7. The prosthesis of claim 1, where the leaflets have a coaptation region between about 1% to about 25% of the body lumen width.

8. The prosthesis of claim 1, where the at least one semi-rigid leaflet is slanted at an angle between about 0 degrees to about 60 degrees above horizontal and the at least one flexible leaflet is slanted at an angle between about 0 degrees to about 60 degrees below horizontal.

10. The prosthesis of claim 1, where the at least one flexible leaflet second portion extends into said body lumen between about 40% to about 75% of the body lumen width.

11. The prosthesis of claim 1, where the at least one semi-rigid leaflet second portion extends into the body lumen between about 25% to about 60% of the body lumen width.

12. The prosthesis of claim 1, where the at least one semi-rigid leaflet and the at least one flexible leaflet have a greater leaflet thickness at the first portion than at the second portion.

13. The prosthesis of claim 1, the semi-rigid leaflet comprising an opening that permits a controlled amount of fluid flow in the second, retrograde direction.

14. The prosthesis of claim 13, where the total area of the opening is less than about 50% of the cross-sectional area of the body lumen at a desired point of treatment in the body lumen.

15. The prosthesis of claim 13, where the total area of the opening is less than about 25% of the cross-sectional area of the body lumen at a desired point of treatment in the body lumen.

16. The prosthesis of claim 13, where the opening is substantially square, substantially triangular, substantially ovoid, or teardrop-shaped.

17. The prosthesis of claim 1, where the frame is radially self-expandable between an unexpanded configuration and an expanded configuration.

9. The prosthesis of clam 8, where the at least one semi-rigid leaflet is slanted at an angle about equal to the slant angle of the least one flexible leaflet.

18. A valve prosthesis for implantation within a body lumen comprising a radially-expandable frame and at least one valve member comprising a semi-rigid leaflet and a flexible leaflet;

the semi-rigid leaflet comprising a first portion coupled to the frame and a second portion free of the frame, the semi-rigid leaflet slanted in a retrograde direction from the second portion to the first portion at an angle between about 0 degrees to about 60 degrees above horizontal;

the flexible leaflet comprising a first portion operatively coupled to the frame and a second portion free of the frame, the flexible leaflet slanted in a retrograde direction from the first portion to the second portion at an angle between about 0 degrees to about 60 degrees below horizontal;

the flexible leaflet being moveable between a first position that permits fluid flow in a first direction and a second position in which the flexible leaflet second portion coapts with the semi-rigid leaflet second portion thus substantially preventing fluid flow in a second, retrograde direction.