Implantable venous valve

• US 8,246,676 B2
• Filed: 09/01/2005
• Issued: 08/21/2012
• Est. Priority Date: 04/16/2001
• Status: Expired due to Fees

• Current Assignee: Biomedical Research Associates Incorporated
• Original Assignee: Biomedical Research Associates Incorporated
• Inventors: Acosta, George M., Kick, George F.
• Primary Examiner(s): Matthews, William H.
• Application Number:
  US11/217,648
• Publication Number:
  US 20060247762A1
• Time in Patent Office: 2,546 Days
• Field of Search: 623/1.11, 623/1.24, 623/2.12, 623/2.17
• US Class Current: 623/1.24
• 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 2/2475 Venous valves

Abstract

A venous valve prosthesis includes a hollow conduit (40) defining a central passageway through which blood may flow. Opposing, pliable leaflet members (30) are located within the conduit and move back and forth between a first, open position, whereby blood may flow through the central passageway in a first direction, and a second, closed position, whereby blood is prevented from backflowing through the central passageway in a second direction which is opposite the first direction. A hollow and generally cylindrical support member (10, 20) retains the leaflet members and is coaxially disposed within the conduit. The support member includes opposing cutaway regions (18) defining two axially extending struts (16) supporting the leaflet members. The cutaway regions, in cooperation with the struts, allow the leaflet members to collapse inwardly to the closed position.

Claims

1. A venous valve prosthesis comprising:

pliable leaflet members configured to move back and forth between an open position allowing blood flow in a forward direction, and a closed position substantially blocking blood backflow;

a hollow and generally cylindrical support member retaining the leaflet members thereon; and

an aperture defined in at least one of the leaflet members such that blood may backflow through the aperture when the leaflets are in the closed position, the aperture allowing a small amount of blood to backflow when the valve is in the closed position so that the closed valve cannot completely stop blood flow in the closed position.

2. The venous valve prosthesis as set forth in claim 1, further comprising:

a surrounding hollow conduit defining a central blood flow passageway, the conduit including an enlarged diameter portion radially encircling said leaflet members.

3. The venous valve prosthesis as set forth in claim 1, further comprising:

a hollow conduit including a porous exterior surface configured to promote tissue ingrowth.

4. The venous valve prosthesis as set forth in claim 1, further comprising:

a hollow conduit including an interior surface configured to promote controlled tissue ingrowth.

5. The venous valve prosthesis as set forth in claim 1, wherein the leaflet members are adhesively fastened to the support member.

6. The venous valve prosthesis as set forth in claim 1, wherein the leaflet members are integrally formed with the support member.

7. The venous valve prosthesis as set forth in claim 1, wherein the venous valve prosthesis includes at least one porous exterior surface comprising a mesh material configured to promote controlled tissue ingrowth.

8. The venous valve prosthesis as set forth in claim 1, wherein the venous valve prosthesis includes at least one porous exterior surface having a pore size of about 10-100 microns configured to promote controlled tissue ingrowth.

9. The venous valve prosthesis as set forth in claim 1, wherein the venous valve prosthesis includes at least one internal wall comprising a polymer surface impregnated with a biologically responsive material to promote controlled tissue ingrowth.

10. The venous valve prosthesis as set forth in claim 1, further comprising:

a hollow conduit defining a central blood flow passageway, the hollow conduit including a bulbous sinus region adjacent the leaflet members.

11. The venous valve prosthesis as set forth in claim 1, wherein the venous valve prosthesis is constructed entirely from synthetic or nonbiological materials.

12. A venous valve prosthesis comprising:

pliable leaflet members configured to move back and forth between an open position allowing blood flow in a forward direction, and a closed position substantially blocking blood backflow;

a hollow and generally cylindrical support member retaining the leaflet members thereon; and

one or more uncovered openings passing through at least one leaflet member.

13. The venous valve prosthesis as set forth in claim 12, wherein the venous valve prosthesis is constructed entirely from synthetic or nonbiological materials.

14. The venous valve prosthesis as set forth in claim 12, wherein the one or more uncovered openings passing through at least one leaflet member cause the pliable leaflet members to slow but not completely stop reverse blood flow in the closed position.

15. A venous valve prosthesis comprising:

a valve assembly including;

a hollow support member defining a central blood flow passageway, and

pliable leaflet members retained by the hollow support member and configured to move back and forth between an open position a closed position substantially blocking the central blood flow passageway;

wherein the valve assembly is configured to allow venous blood flow in a forward direction through the central blood flow passageway when the pliable leaflet members are in the open position; and

wherein the valve assembly includes one or more openings passing through at least one of the pliable leaflet members such that the valve assembly slows but not completely stop venous blood flow in a reverse direction through the central blood flow passageway when the pliable leaflet members are in the closed position.

16. The venous valve prosthesis as set forth in claim 15, wherein the venous valve prosthesis is constructed entirely from synthetic or nonbiological materials.

17. The venous valve prosthesis as set forth in claim 15, wherein the one or more openings are uncovered openings.