Implantable venous valve

• US 20020177894A1
• Filed: 04/16/2002
• Published: 11/28/2002
• Est. Priority Date: 04/16/2001
• Status: Active Grant

• Current Assignee: Biomedical Research Associates Incorporated
• Original Assignee: Biomedical Research Associates Incorporated
• Inventors: Kick, George F., Acosta, George M.
• Granted Patent: US 6,958,076 B2
• Time in Patent Office: Days
• 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:

a hollow conduit defining a central passageway through which blood may flow;

opposing pliable leaflet members located within the conduit, the leaflets configured to 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 retaining the leaflet members thereon and coaxially disposed within the conduit, the support member comprising opposing cutaway regions defining two axially extending struts supporting the leaflet members, the cutaway regions in cooperation with said struts configured to allow the leaflet members to collapse inwardly to the closed position.

2. The venous valve prosthesis of claim 1, wherein the support member further comprises:

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

3. The venous valve prosthesis of claim 1, wherein the support member includes a generally circular cross-sectional diameter and an axial length which is about 1.5 times said cross-sectional diameter.

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

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

6. The venous valve prosthesis of claim 1, wherein the leaflets are configured to remain open during forward flow and no flow states, and to close in response to a reverse blood flow state.

7. The venous valve prosthesis of claim 1, wherein the leaflets are configured to remain open during forward flow and no flow states, and to close in response to reverse fluid pressure.

8. The venous valve prosthesis of claim 7, wherein said leaflets are configured to close in response to a reverse fluid pressure as low as 3 mm Hg.

9. The venous valve prosthesis of claim 8, wherein said leaflets are configured to close in response to a reverse fluid pressure as low as 1 mm Hg.

10. The venous valve prosthesis of claim 1, wherein the conduit is generally cylindrical.

11. The venous valve prosthesis of claim 1, wherein the conduit further comprises:

an enlarged diameter portion radially encircling said leaflets.

12. The venous valve prosthesis of claim 1, wherein the conduit comprises a porous exterior surface configured to promote tissue ingrowth.

13. The venous valve prosthesis of claim 1, wherein the conduit comprises an interior surface configured to promote controlled tissue ingrowth.

14. The venous valve prosthesis of claim 1, wherein the conduit comprises a stent.

15. The venous valve prosthesis of claim 14, further comprising a plurality of nibs disposed on the support body for attaching the body to the stent.

16. The venous valve prosthesis of claim 1, wherein the conduit further comprises one or more suture loops for anchoring the venous valve prosthesis within a blood vessel.

17. The venous valve prosthesis of claim 1, wherein the leaflets are adhesively fastened to the support body.

18. The venous valve prosthesis of claim 1, wherein the leaflets are integrally formed with the support body.

19. The venous valve prosthesis of claim 1, wherein a surface of at least one of the leaflet members defines an aperture such that blood may backflow through the aperture when the leaflets are in a closed position.

20. A method of implanting a prosthetic valve within a blood vein, comprising:

providing a prosthetic valve apparatus including;

(a) a hollow conduit defining a central passageway through which blood may flow;

(b) opposing pliable leaflet members located within the conduit, the leaflets configured to 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; and

(c) a hollow and generally cylindrical support member retaining the leaflet members thereon and coaxially disposed within the conduit, the support member comprising opposing cutaway regions defining two axially extending struts supporting the leaflet members, the cutaway regions in cooperation with said struts configured to allow the leaflet members to collapse inwardly to the closed position;

forming an opening in either;

(i) said vein;

or (ii) a blood vessel in fluid communication with said vein;

inserting the prosthetic valve apparatus through the formed opening to a desired location and orienting the prosthetic valve apparatus coaxially within the vein such that the leaflet members and struts extend in the direction of forward blood flow; and

anchoring the prosthetic valve apparatus in the desired position.

21. The method of claim 20, wherein forming an opening comprises:

incising the vein so that the incision formed is oriented generally longitudinally therein, and wherein the incision has a length shorter than an axial length of the prosthetic valve apparatus.

22. The method of claim 20, wherein said opening formed in the vein is formed at a location spaced apart from said desired location at which said prosthetic valve apparatus is to be implanted, said method further comprising:

advancing the prosthetic valve apparatus percutaneously to said desired location.

23. The method of claim 22, wherein the hollow conduit is a stent.

24. The method of claim 23, wherein the support member and leaflet members are attached to the stent by means of one or more nibs disposed on an outer surface of said support member or said leaflet members, whereby said nibs create a pathway through which blood may backflow when the leaflets are in a closed position.

25. The method of claim 22, wherein the prosthetic valve apparatus is advanced via a catheter.

26. The method of claim 22, further comprising:

prior to advancing the prosthetic valve apparatus, dilating the vein with a stent.

27. The method of claim 20, wherein anchoring the prosthetic valve apparatus comprises:

fastening the valve prosthetic apparatus to the vein with one or more sutures.

28. The method of claim 20, wherein anchoring the prosthetic valve apparatus comprises:

applying a circumferential ligature around the vein in axial alignment with an inlet end of said support body.

29. The method of claim 28, wherein the inlet end of said support body comprises:

a plurality of axially spaced apart circumferential ridges thereon defining an annular channel therebetween, said channel in axial alignment with said circumferential ligature.

30. The method of claim 20, further comprising:

closing the opening formed in the vein.

31. The method of claim 30, further comprising:

prior to closing the opening formed in the vein, eliminating air from the vein and priming the prosthetic valve apparatus with blood.

32. A method of making a venous valve prosthesis comprising:

fastening pliable leaflets to a hollow and generally cylindrical support member comprising opposing cutaway regions defining two axially extending struts to form a valve subassembly, the leaflets overlaying said cutaway regions and supported by said struts, said leaflets configured to 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, said cutaway regions in cooperation with said struts configured to allow the leaflet members to collapse inwardly to the closed position; and

coaxially affixing the valve subassembly within a hollow conduit defining a central passageway through which blood may flow.

33. A method of treating valvular insufficiency in a patient suffering therefrom, wherein a prosthetic valve apparatus is inserted into a vein of the patient at a first location selected to restore a valve function in the vein, the prosthetic valve comprising:

a support body of synthetic material and of generally cylindrical shape having a lower circumferential base portion, opposing cutaway regions defining opposing and axially extending struts;

two opposing flexible valve cusps of synthetic material secured to the support body opening and closing the valve, the valve cusps and cutaway regions being dimensioned such that the valve cusps are collapsible against each other to a closed position; and

a hollow conduit enclosing the support body and flexible valve cusps.

34. The method of claim 33, wherein the prosthetic valve apparatus is implanted surgically in said first location.

35. The method of claim 33, wherein the prosthetic valve apparatus is inserted into a vein of the patient at a second location and advanced percutaneously to said first location.

36. The method of claim 35, wherein the prosthetic valve apparatus is inserted into a vein of a patient using a catheter.

37. The method of claim 36, wherein the hollow conduit is a stent.

38. The method of claim 37, wherein the support body is attached to the stent by means of one or more nibs disposed on an outside surface of said support body, whereby said nibs create a pathway through which blood may backflow when the cusps are in a closed position.

39. The method of claim 33, wherein the patient is human.

40. The method of claim 33, wherein the patient is suffering from chronic venous ulcer.

41. A venous valve prosthesis, comprising:

opposing pliable leaflet members, the leaflets configured to move back and forth between a first, open position, whereby blood may flow through a 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 retaining the leaflet members thereon, the support member comprising opposing cutaway regions defining two axially extending struts supporting the leaflet members, the cutaway regions in cooperation with said struts configured to allow the leaflet members to collapse inwardly to the closed position; and

one or more nibs disposed on an outside surface of said support member at a circumferential point below said cutaway regions for engaging with an intraveous stent.

42. A method of implanting a prosthetic valve within a blood vein, comprising:

providing a prosthetic valve apparatus including;

(b) opposing pliable leaflet members, the leaflets configured to 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;

(b) a hollow and generally cylindrical support member retaining the leaflet members thereon, the support member comprising opposing cutaway regions defining two axially extending struts supporting the leaflet members, the cutaway regions in cooperation with said struts configured to allow the leaflet members to collapse inwardly to the closed position; and

(c) one or more nibs disposed on an outside surface of said support member at a circumferential point below said cutaway regions for engaging with an intraveous stent;

forming an opening in either;

(i) said vein;

or (ii) a blood vessel in fluid communication with said vein;

mounting said valve apparatus on a balloon catheter;

positioning a stent over said valve apparatus such that said valve apparatus is secured to said stent and inserting said nibs through apertures defined in said stent;

inserting the balloon catheter through the formed opening to a desired location and orienting the prosthetic valve apparatus and stent assembly coaxially within the vein such that the leaflet members and struts extend in the direction of forward blood flow; and

anchoring the stent in the desired position by attaching barbs disposed on an outside surface of said stent to a wall of said vein.