Implantable venous valve

• US 6,958,076 B2
• Filed: 04/16/2002
• Issued: 10/25/2005
• Est. Priority Date: 04/16/2001
• Status: Expired due to Fees

• Current Assignee: Biomedical Research Associates Incorporated
• Original Assignee: Biomedical Research Associates Incorporated
• Inventors: Kick, George F., Acosta, George M.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): MATTHEWS, WILLIAM H
• Application Number:
  US10/123,649
• Publication Number:
  US 20020177894A1
• Time in Patent Office: 1,288 Days
• Field of Search: 623/1.11, 623/1.24, 623/2.17, 623/2.12
• 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:

opposing pliable nonbiological leaflet members configured to selectively shift between a first normally open position whereby fluid may flow in a first direction through an axial passageway defined between the leaflet members and a second closed position whereby fluid is prevented from backflowing through the axial passageway in a second direction opposite the first direction, the leaflets being normally open and only closing upon reversal of fluid flow to the second direction; and

,

an elongated hollow support member cooperably receiving the leaflet members, the support member including opposed cutaway regions defining a pair of struts extending axially of the support member for supporting the leaflet members, the cutaway regions in cooperation with said struts configured for allowing the leaflet members to selectively collapse inwardly toward the second closed position.

2. The venous valve prosthesis of claim 1 wherein the support member further includes a plurality of axially spaced apart peripheral ridges defining a channel therebetween.

3. The venous valve prosthesis of claim 1 wherein the support member has a generally circular cross-section and an axial length which is approximately 1.5 times the cross-sectional dimension.

4. The venous valve prosthesis of claim 1 wherein the leaflet members are comprised of an aromatic polyurethane film.

5. The venous valve prosthesis of claim 1 wherein the leaflet members are defined by a tubular member coaxially retained on the support member.

6. The venous valve prosthesis of claim 1 wherein the leaflets are adapted to shift from the first normally open position to the second closed position in response to fluid pressure through the axial passageway in the second direction.

7. The venous valve prosthesis of claim 6 wherein the leaflets are configured to shift from the open position to the closed position in response to a reverse fluid pressure at least as low as 3 mm Hg.

8. The venous valve prosthesis of claim 6 wherein the leaflets are configured to shift from the open position to the closed position in response to a reverse fluid pressure as low as 1 mm Hg.

9. The venous valve prosthesis of claim 1 wherein the leaflets are adhesively secured to the support member.

10. The venous valve prosthesis of claim 1 wherein the leaflets are integrally formed with the support member.

11. The venous valve prosthesis of claim 1 wherein a surface of at least one of the leaflet members defines an aperture adapted to facilitate fluid backflow therethrough in the second direction when the leaflets are in the closed position.

12. The venous valve prosthesis of claim 1 wherein the valve is adapted for operable disposition in close surrounded relation with a supporting conduit.

13. The venous valve prosthesis of claim 12, wherein the conduit further comprises:

an enlarged diameter portion radially encircling said leaflets.

14. The venous valve prosthesis of claim 12, wherein the conduit comprises a porous exterior surface configured to promote tissue ingrowth.

15. The venous valve prosthesis of claim 12, wherein the conduit comprises an interior surface configured to promote controlled tissue ingrowth.

16. The venous valve prosthesis of claim 12, wherein the conduit comprises a stent.

17. The venous valve prosthesis of claim 16, further comprising a plurality of nibs disposed on the support member for attaching the support member to the stent.

18. The venous valve prosthesis of claim 16, wherein the conduit further comprises one or more suture loops for anchoring the venous valve prosthesis within a blood vessel.

19. A venous valve replacement comprising:

a frame defining a flow inlet end and a flow outlet end of a blood flow path, the frame having a plurality of struts at the flow outlet end; and

a one-piece generally tubular nonbiological leaflet structure disposed entirely coaxially around the frame including the struts, the generally tubular leaflet structure defining leaflets positioned at the gaps between the struts, the leaflets collapsing into the gaps between the struts to block the blood flow path responsive to a backflow of blood from the flow outlet end toward the flow inlet end.

20. The venous valve replacement as set forth in claim 19, wherein the leaflets maintain an open position outside the gaps between the struts for substantially any forward flow of blood through the blood flow path from the flow inlet end toward the flow outlet end.

21. The venous valve replacement as set forth in claim 19, wherein the generally tubular leaflet structure does not contribute to defining a minimum constriction of the blood flow path in the absence of backflow of blood through the blood flow path from the flow outlet end toward the flow inlet end.

22. The venous valve replacement as set forth in claim 19, wherein the generally tubular leaflet structure is integrally formed with the frame.

23. A venous valve prosthesis comprising:

a frame defining a blood flow path in which blood normally flows in a forward direction from a flow inlet end of the frame to a flow outlet end of the frame, the frame having a plurality of struts disposed at the flow outlet end; and

a plurality of nonbiological leaflets positioned at gaps between the struts at the flow outlet end of the frame, the leaflets being supported by the struts in a normally open position during normal blood flow and in the no blood flow state so as not to restrict the normal blood flow from the flow inlet end to the flow outlet end, the leaflets collapsing into the gaps between the struts to block the blood flow path responsive to a reversal of blood flow through the blood flow path.

24. The venous valve prosthesis of claim 23, wherein the frame further comprises:

a plurality of axially spaced apart circumferential ridges defining an annular channel therebetween.

25. The venous valve prosthesis of claim 23, wherein the nonbiological leaflets comprise an aromatic polyurethane film.

26. The venous valve prosthesis of claim 23, wherein the nonbiological leaflets comprise a tubular member coaxially retained on the frame.

27. The venous valve prosthesis of claim 23, wherein the leaflets are adhesively fastened to the frame.

28. The venous valve prosthesis of claim 23, wherein the leaflets are integrally formed with the frame.

29. The venous valve prosthesis of claim 23, wherein a surface of at least one of the nonbiological leaflets defines an aperture such that blood may backflow through the aperture when the leaflets are in a closed position.

30. The venous valve prosthesis as set forth in claim 23, further comprising:

a generally tubular leaflet structure coaxially disposed entirely around the outside of the frame including the struts, the generally tubular leaflet structure defining the plurality of leaflets.