FRAMELESS VASCULAR VALVE

• US 20100114307A1
• Filed: 11/05/2009
• Published: 05/06/2010
• Est. Priority Date: 11/06/2008
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Patel, Umesh H., Agnew, Charles W.
• Granted Patent: US 8,556,960 B2
• Time in Patent Office: Days
• US Class Current: 623/2.120
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062

Abstract

Prosthetic valve devices, as well as systems and methods for the delivery thereof, are disclosed. A device includes one or more leaflets disposed within a frameless conduit, wherein the conduit is adapted for attachment to walls of a vascular vessel, and the leaflets are adapted for attachment to walls of the conduit. The leaflets are configured to selectively restrict blood flow through the conduit, and the conduit can include wall-engaging adaptations, for example, barbs or an adhesive. The conduit and the leaflets are formed with a flexible material, which may comprise a remodelable material and/or a synthetic polymer.

Claims

1. A valve prosthesis suitable for implantation, comprising:

a frameless conduit adapted to attach to a vein wall; and

at least one leaflet disposed within the conduit to selectively restrict blood flow through the conduit,

wherein said conduit and said leaflet are formed with a flexible material.

2. The valve prosthesis of claim 1, wherein said flexible material comprises a remodelable material.

3. The valve prosthesis of claim 2, wherein said remodelable material comprises an extracellular matrix material.

4. The valve prosthesis of claim 3, wherein said extracellular matrix material comprises serosa, pericardium, submucosa, dura mater, peritoneum, or dermal collagen.

5. The valve prosthesis of claim 1, wherein said flexible material comprises a synthetic polymeric material.

6. The valve prosthesis of claim 1, further comprising at least one anchoring element effective to secure said conduit to the vein wall.

7. The valve prosthesis of claim 1, wherein said conduit comprises a remodelable material.

8. The valve prosthesis of claim 7, wherein said leaflet comprises a synthetic polymeric material.

9. The valve prosthesis of claim 1, wherein said leaflet has an edge for contacting a wall of said conduit.

10. The valve prosthesis of claim 9, wherein said edge is configured to extend longitudinally along and at least partially circumferentially around the conduit wall.

11. The valve prosthesis of claim 9, wherein said edge is attached to said conduit.

12. The valve prosthesis of claim 1, wherein said leaflet has a base integral with said conduit.

13. The valve prosthesis of claim 1, wherein said leaflet has a base non-integral with said conduit.

14. The valve prosthesis of claim 1, wherein said leaflet has sides attached to said conduit.

15. The valve prosthesis of claim 1, wherein said leaflet provides material extending beyond a top end of said conduit.

16. The valve prosthesis of claim 1, wherein said leaflet provides material extending beyond a bottom end of said conduit.

17. The valve prosthesis of claim 1, wherein:

said conduit has conduit walls formed with a sheet of material formed into a tube; and

said leaflet is formed by cutting material contiguous with said walls.

18. The valve prosthesis of claim 1, wherein:

said conduit has conduit walls formed with a tube of material; and

said leaflet is formed by cutting material contiguous with said walls.

19. The valve prosthesis of claim 1, wherein:

said frameless conduit provides an inner conduit; and

said prosthesis further comprises a frameless outer conduit,

wherein said inner conduit is received concentrically within said outer conduit.

20. The valve prosthesis of claim 19, wherein:

said inner conduit has a slit in a side wall thereof; and

said outer conduit has a leaflet integrally formed therewith, said leaflet received through said slit to dispose at least a portion of the leaflet within the inner conduit.

21. The valve prosthesis of claim 1, wherein:

said conduit has a slit in a side wall thereof; and

said leaflet has a base received within said slit.

22. The valve prosthesis of claim 21, wherein a portion of said base is configured to contact a wall of a vascular vessel through said slit.

28. A method for attaching a frameless valve prosthesis to a vein, comprising:

providing the valve prosthesis of claim 1; and

attaching the frameless valve prosthesis to a wall of a vein.

29. A method of modifying blood flow in a vascular vessel, the method comprising:

percutaneously delivering the valve prosthesis of claim 1 to a site within a vascular vessel; and

percutaneously attaching at least a portion of said valve prosthesis to walls of said vascular vessel, whereby said valve prosthesis selectively permits blood flow in a first direction and selectively restricts blood flow in a second direction.

23. A valve prosthesis, comprising:

an outer conduit having a first end and a second end; and

an inner conduit having a first end and a second end,

wherein said inner conduit is received concentrically within said outer conduit,

wherein said first end of said outer conduit provides material extending beyond said first end of said inner conduit,

wherein said first end of said outer conduit is arranged to selectively restrict fluid flow in a direction from said first end to said second end of said inner conduit.

24. The valve prosthesis of claim 23, wherein said inner conduit is more rigid than said outer conduit.

25. A frameless valve prosthesis, comprising:

a conduit element having a first end; and

a valve element having a base integral with the first end of the conduit element,

wherein said valve element and at least a portion of said conduit element are formed with a remodelable material.

26. The valve prosthesis of claim 25, wherein said remodelable material comprises an extracellular matrix.

27. The valve prosthesis of claim 25, wherein said valve element has a reinforced base.