In situ venous valve device and method of formation

• US 6,241,763 B1
• Filed: 06/08/1999
• Issued: 06/05/2001
• Est. Priority Date: 06/08/1999
• Status: Expired due to Fees

• Current Assignee: Thielen, Joseph M., William J. Drasler
• Original Assignee: Thielen, Joseph M., William J. Drasler
• Inventors: Drasler, William J., Thielen, Joseph M.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US09/328,835
• Time in Patent Office: 728 Days
• Field of Search: 623/1-4-, 623/1.41, 623/2.12, 623/2.13, 623/2.15, 623/2.16
• 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 2/2475 Venous valves

Abstract

A venous valve device and method of formation are described to provide antegrade blood flow in the deep venous vessels of the leg or in other venous vessels of the body having incompetent or irreversibly dysfunctional valves. A venous valve is formed in situ from autologous vein conduit not having a valve present locally. An overlap region is formed by attaching two opposing walls of the vein together in a generally axial direction forming two tubular regions. One region provides antegrade blood flow and the other region provides a sinus cavity that is filled during the initiation of retrograde blood flow. A valve cusp is formed by attaching vessel wall together forming a commissure that extends between the two overlap regions. A single valve cusp moves toward the sinus cavity to allow antegrade blood flow and moves away from the sinus cavity to block retrograde blood flow. Inlet and outlet transition regions can be formed to provide hemodynamic antegrade blood flow through the valve. The autologous tissue valve remains endothelialized to prevent thrombus deposit in the valve. The venous valve can also be formed from biological tissue from an autologous, heterologous, or other tissue source and implanted interpositionally at the site of valvular incompetency.

Claims

1. A venous valve for directing antegrade blood flow in an autologous vein of the body that requires a venous valve, said venous valve comprising a tubular conduit means from which said venous valve is formed, said tubular conduit means having a tubular conduit inlet end, a tubular conduit outlet end, and a tubular conduit wall;

a portion of the tubular conduit wall being attached to another portion of the tubular conduit wall substantially from the inlet to the outlet end of said tubular conduit means forming two tubular members, a first tubular member having a first tubular member wall, and a second tubular member having a second tubular member wall;

a portion of said first tubular member wall being attached to a portion of said second tubular member wall to position a substantial portion of said first tubular member wall in approximation with a substantial portion of said second tubular member wall with an approximation attachment;

an inlet end of said second tubular member having a closure attachment to prevent antegrade blood flow from entering said second tubular member and to prevent retrograde blood flow from passing through said second tubular means;

a portion of said first tubular member wall being attached via a valve cusp attachment to a portion of said second tubular member wall at approximately the outlet end of said tubular conduit member to form at least a portion of a valve cusp, said valve cusp directing retrograde blood flow into an outlet end of said second tubular member and preventing substantial retrograde blood flow through said first tubular member;

whereby said venous valve directs antegrade blood flow from said tubular conduit inlet end to said tubular conduit outlet end and prevents substantial retrograde blood flow from said tubular conduit outlet end to said tubular conduit inlet end.

2. The venous valve of claim 1 wherein said tubular conduit means is an autologous vein segment with endothelium on at least a portion of an inner surface.

3. The venous valve of claim 2 wherein said autologous vein segment is contiguous with the autologous vein that requires a venous valve.

4. The venous valve of claim 2 wherein said valve cusp has an endothelialized surface.

5. The venous valve of claim 2 wherein said valve cusp has an inverted fold with endothelium covering said valve cusp.

6. The venous valve of claim 1 further comprising an inlet transition region joined to said tubular conduit means and extending from said tubular conduit inlet end to an inlet end of the autologous vein requiring a venous valve, said inlet transition region having a tapered tubular shape with an inlet transition lumen.

7. The venous valve of claim 6 wherein said inlet transition region has an inlet transition beveled attachment formed by the attachment of a portion of a first sector to a portion of a second sector along a wall line that extends from said tubular conduit inlet end to the inlet end of the autologous vein requiring a venous valve.

8. The venous valve of claim 7 wherein excess inlet transition tissue extends outside said inlet transition beveled attachment and outside said inlet transition lumen.

9. The venous valve of claim 8 wherein said excess inlet transition tissue is cut off or removed.

10. The venous valve of claim 7 wherein excess inlet transition tissue extends inside said inlet transition beveled attachment and inside said inlet transition lumen.

11. The venous valve of claim 1 further comprising an outlet transition region joined to said tubular conduit means extending from said tubular conduit outlet end to an outlet end of the autologous vein requiring a venous valve, said outlet transition region having a tapered tubular shape with an outlet transition lumen.

12. The venous valve of claim 11 wherein said outlet transition region has an outlet transition beveled attachment formed by the attachment of a portion of a first sector to a portion of a second sector along a wall line that extends from said tubular conduit outlet end to the outlet end of the autologous vein requiring a venous valve.

13. The venous valve of claim 12 wherein excess outlet transition tissue extends inside said outlet transition attachment and inside said outlet transition lumen.

14. The venous valve of claim 1 further comprising;

A. an inlet transition region joined to said tubular conduit means extending from said tubular conduit inlet end to an inlet end of the autologous vein requiring a venous valve, said inlet transition region having a tapered tubular shape with an inlet transition lumen, and;

B. an outlet transition region joined to said tubular conduit means extending from said tubular conduit outlet end to an outlet end of the autologous vein requiring a venous valve, said outlet transition region having a tapered tubular shape with an outlet transition lumen.

15. The venous valve of claim 14 wherein said inlet and outlet transition regions are formed from an autologous vein segment.

16. The venous valve of claim 15 wherein said autologous vein segment is contiguous with the autologous vein that requires a venous valve.

17. The venous valve of claim 1 wherein said valve cusp has a valve cusp length in a generally axial direction that is greater than one half of a diameter of said first tubular member.

18. The venous valve of claim 1 wherein said first tubular member has a first tubular member diameter that is less than the diameter of the autologous vein that requires a venous valve.

19. The venous valve of claim 1 wherein said approximation attachment, said closure attachment, and said valve cusp attachment is comprised of attachment means taken from a group consisting of staples, suture, adhesives, bonding agents, metal strand material, polymeric strand material, laser fusion, or thermal fusion.

20. The venous valve of claim 1 wherein said tubular conduit means has a wall support means attached to prevent distension of at least a portion of said tubular conduit means.

21. The venous valve of claim 1 wherein said first tubular member or said second tubular member have wall support means attached to said first tubular member wall or said second tubular member wall between said inlet and outlet end of said first or second tubular member to prevent distension.

22. The venous valve of claim 1 wherein said tubular conduit means is a nonautologous biological conduit.

23. The venous valve of claim 1 wherein said tubular conduit means is an autologous tissue formed into a tubular shape.

24. The venous valve of claim 1 wherein said tubular conduit means is a polymeric conduit.

25. The venous valve of claim 1 wherein said tubular conduit means is a conduit formed of a composite material.

26. A venous valve for directing antegrade blood flow in a vascular conduit of a body that requires a venous valve, said venous valve comprising a tubular conduit means from which said venous valve is formed, said tubular conduit means having a tubular conduit inlet end, a tubular conduit outlet end, and a tubular conduit wall, said tubular conduit wall having tubular conduit wall lines that extend within said tubular conduit wall and having a tubular conduit axial direction component, said tubular conduit wall being divided into sectors;

at least a portion of a wall line of one sector forming a divisional attachment to at least a portion of a wall line of another sector to form two tubular members, a first tubular member having a first tubular member wall, and first tubular member wall lines within said first tubular member wall with an axial direction component, and a second tubular member having a second tubular member wall and second tubular member wall lines within said second tubular member wall with an axial direction component;

at least a portion of at least one of said first tubular member wall lines forms an approximation attachment to at least a portion of at least one of said second tubular member wall lines to position at least a portion of said first tubular member wall in approximation with at least a portion of said second tubular member wall;

at least a portion of said second tubular member wall at an inlet end of said second tubular member forms a closure attachment to prevent antegrade blood flow from entering said second tubular member and to prevent retrograde blood flow from passing through said second tubular member;

a portion of said first tubular member wall forms a valve cusp attachment to a portion of said second tubular member wall to form at least a portion of a valve cusp, said valve cusp directing retrograde blood flow into said second tubular member and preventing retrograde blood flow through said first tubular member;

whereby said venous valve directs antegrade blood flow from said tubular conduit inlet end to said tubular conduit outlet end and prevents retrograde blood flow from said tubular conduit outlet end to said tubular conduit inlet end.

27. A venous valve for directing antegrade blood flow in a vascular conduit of a body that requires a venous valve, said venous valve comprising a tubular means from which said venous valve is formed, said tubular means having a tubular conduit inlet end, a tubular conduit outlet end, and a tubular conduit wall, said tubular conduit wall having tubular conduit wall lines that extend within said tubular conduit wall and having a tubular conduit axial direction component;

a portion of one wall line being attached to a portion of another wall line forming two tubular members, a first tubular member having a first tubular member wall, and first tubular member wall lines with an axial direction component, and a second tubular member having a second tubular member wall and second tubular member wall lines with an axial direction component;

a portion of at least one of said first tubular member wall lines being attached to a portion of at least one of said second tubular member wall lines to position a portion of said first tubular member wall in approximation with a portion of said second tubular member wall;

a portion of said second tubular member wall at a first end of said second tubular member being attached to prevent antegrade blood flow from entering said first end of said second tubular member and to prevent retrograde blood flow from passing through said second tubular member;

a portion of said first tubular member wall being attached to a portion of said second tubular member wall to form at least a portion of a valve cusp, said valve cusp directing retrograde blood flow into a second end of said second tubular member and preventing retrograde blood flow through said first tubular member;

whereby said venous valve directs antegrade blood flow from said tubular conduit inlet end to said tubular conduit outlet end and prevents retrograde blood flow from said tubular conduit outlet end to said tubular conduit inlet end.

28. A venous valve for directing antegrade venous blood flow in the vascular system of a body toward the heart through an autologous vein with that requires a venous valve, said venous valve comprising;

A. a tubular conduit means from which said venous valve is formed, said tubular conduit means having a tubular conduit inlet end, a tubular conduit outlet end, a tubular conduit axial direction, a tubular conduit axial length, a tubular conduit diameter, and a tubular conduit wall, said tubular conduit wall having tubular conduit wall lines that extend within said tubular conduit wall and having a tubular conduit axial direction component, said tubular conduit wall being divided into sectors, said tubular conduit wall having an inner surface and an outer surface;

B. a divisional attachment formed by the attachment of at least a portion of a first sector wall line of a first sector to at least a portion of a second sector wall line of a second sector along at least a portion of the axial length of said tubular means to form two tubular members of said tubular means, a first tubular member and a second tubular member, said first tubular member having a first tubular member inlet end, first tubular member outlet end, first tubular member wall, and first tubular member wall lines within said first tubular member wall with a first tubular member axial direction component, and said second tubular member having a second tubular member inlet end, second tubular member outlet end, second tubular member wall, and second tubular member wall lines within said second tubular member wall with a second tubular member axial direction component;

C. an approximation attachment formed by the attachment of at least a portion of at least one of said first tubular member wall lines to at least a portion of at least one of said second tubular member wall lines to position at least a portion of said first tubular member wall in approximation with at least a portion of said second tubular member wall;

D. a closure attachment formed by the attachment of at least a portion of said second tubular member wall at said second tubular member inlet end to substantially prevent antegrade blood flow from entering said second tubular member inlet end and to substantially prevent retrograde flow from flowing through said second tubular member;

E. a valve cusp attachment formed by the attachment of a portion of said first tubular member wall to a portion of said second tubular member wall to form at least a portion of a valve cusp, said valve cusp substantially preventing retrograde blood flow through said first tubular member.

29. A method for forming a venous valve for directing antegrade venous blood flow through a vein, said method comprising the steps of;

A. identifying and isolating a tubular conduit means from which said venous valve is formed, said tubular conduit means having a tubular conduit inlet end, a tubular conduit outlet end, and a tubular conduit wall;

B. forming a divisional attachment between two portions of tubular conduit means to form two tubular members, a first and second tubular member, with first and second tubular member walls, respectively;

C. forming a closure attachment at an inlet end of said second tubular member to prevent antegrade blood flow from entering said second tubular member and to substantially prevent retrograde flow from flowing through said second tubular member;

D. forming a valve cusp attachment by attaching a portion of wall of said first tubular member wall to a portion of wall of said second tubular member wall using attachment means to form at least a portion of a valve cusp;

said valve cusp directing retrograde blood flow into an outlet end of said second tubular member and substantially preventing retrograde blood flow through said first tubular member;

E. forming an approximation attachment by attaching at least a portion of said first tubular member wall to at least a portion of said second tubular member wall using attachment means to position at least a portion of said first tubular member wall in approximation with at least a portion of said second tubular member wall;

F. thereby directing antegrade blood flow through said first tubular member and substantially preventing retrograde blood flow through said first tubular member.

30. The method of claim 29 wherein said venous valve is formed with the tubular conduit means in substantially a flat conformation.

31. The method of claim 29 wherein said attachment means are selected from the group consisting of suture, staples, metallic fiber, polymeric fiber, adhesives, biological bonding agents, laser fusion methods, and thermal fusion methods.

32. The method of claim 29 wherein said tubular conduit means is an autologous vein segment with an inlet end and an outlet end, said autologous vein segment being contiguous with an autologous vein requiring a venous valve and the formation of said venous valve being conducted in situ.

33. The method of claim 32 further comprising the steps of;

A. forming an inlet transition region from said autologous vein segment, said inlet transition region having a tapered tubular shape with an inlet transition lumen and extending from said tubular conduit inlet end to said autologous vein requiring a venous valve;

B. forming an outlet transition region from said autologous vein segment, said outlet transition region having a tapered tubular shape with an outlet transition lumen and extending from said tubular conduit outlet end to said autologous vein requiring a venous valve.

34. The method of claim 32 wherein said forming of said valve cusp attachment comprises the steps of;

A. forming a transverse attachment along a portion of said inlet end and said outlet end of said autologous vein segment;

B. cutting said autologous vein segment adjacent to said inlet and outlet end;

C. forming an inverted fold between said inlet and outlet end of said autologous vein segment, thereby providing a valve cusp that is entirely endothelialized.

35. The method of claim 33 further comprising the steps;

A. forming an inlet transition beveled attachment by attaching a portion of a first sector to a portion of a second sector along a wall line that extends from said tubular conduit inlet end to the autologous vein requiring a venous valve;

B. forming excess tissue outside said inlet transition attachment and outside said inlet transition lumen.

36. The method of claim 35 further comprising the steps of cutting off and removing said excess tissue using scissors, scalpel, or other cutting means.

37. The method of claim 33 further comprising the steps;

A. forming an inlet transition beveled attachment by attaching a portion of a first sector to a portion of a second sector along a wall line that extends from said first tubular member inlet end and said second tubular member inlet end to the autologous vein requiring a venous valve;

B. forming an outlet transition attachment by attaching a portion of a first sector to a portion of a second sector along a wall line that extends from said first tubular member outlet end and said second tubular member outlet end to the autologous vein requiring a venous valve;

C. forming excess tissue outside said inlet and said outlet transition attachment and outside said inlet and outlet transition lumen.

38. The method of claim 33 further comprising the steps;

A. forming an inlet transition beveled attachment by attaching a portion of a first sector to a portion of a second sector along a wall line that extends from said first tubular member inlet end and said second tubular member inlet end to the autologous vein requiring a venous valve;

B. forming an outlet transition beveled attachment by attaching a portion of a first sector to a portion of a second sector along a wall line that extends from said first tubular member outlet end and said second tubular member outlet end to the autologous vein requiring a venous valve;

C. forming excess tissue inside said inlet and said outlet transition attachment and inside said inlet and outlet transition lumen.

39. The method of claim 29 wherein said tubular conduit means is not an autologous vein segment contiguous with an autologous vein requiring a venous valve, said tubular conduit means being formed into said venous valve and implanted interpositionally into the autologous vein that requires a venous valve using attachment means to provide a leak free seal between said venous valve and said autologous vein requiring a venous valve.

40. A method for forming a venous valve for directing antegrade venous blood flow through a vein, said method comprising the steps of;

A. identifying and providing a tubular conduit means from which said venous valve is formed, said tubular conduit means having a tubular conduit inlet end, a tubular conduit outlet end, and a tubular conduit wall, said tubular conduit wall having tubular conduit wall lines that extend within said tubular conduit wall and having a tubular conduit axial direction component, said tubular conduit wall being divided into sectors;

B. forming an inlet valve cusp attachment by attaching a portion of a tubular conduit wall from a first sector to a tubular conduit wall of a second sector at approximately the inlet end of said tubular conduit means to form at least a portion of a valve cusp;

C. forming an outlet valve cusp attachment by attaching a portion of a tubular conduit wall from a first sector to a tubular conduit wall of a second sector at approximately the outlet end of said tubular conduit means to form at least a portion of a valve cusp;

D. cutting said tubular conduit means adjacent to and in a retrograde direction from said inlet valve cusp attachment, and cutting said tubular conduit means adjacent to an in an antegrade direction from said outlet valve cusp attachment;

E. invert folding the first and second sectors such that a first wall line located adjacent to said first and second sectors is in apposition to a second wall line that is not adjacent to said first and second sectors;

F. forming a divisional attachment by attaching at least a portion of said first wall line to at least a portion of said second wall line to form two tubular members, a first tubular member having a first tubular member wall and providing an antegrade blood through-flow path, and a second tubular member having a second tubular member wall and providing at least a portion of a sinus member;

G. forming a closure attachment by attaching said second tubular member wall at approximately the inlet end of said tubular conduit means using attachment means to prevent antegrade blood flow from entering said second tubular member inlet end and to prevent retrograde blood flow from passing through said second tubular member;

H. forming an approximation attachment by attaching at least a portion of said first tubular member wall to at least a portion of said second tubular member wall using attachment means to position at least a portion of said first tubular member wall in approximation with at least a portion of said second tubular member wall thereby causing said valve cusp to prevent retrograde blood flow through said first tubular member and allow antegrade blood flow through said first tubular member.

41. The method of claim 40 wherein said tubular conduit means is an autologous vein segment with an inlet end and an outlet end, said autologous vein segment being contiguous with an autologous vein requiring a venous valve and the formation of said venous valve is in situ.

42. The method of claim 41 further comprising the steps of;

A. forming an inlet transition region from said autologous vein segment, said inlet transition region having a tapered tubular shape with an inlet transition lumen and extending from said tubular conduit inlet end to said autologous vein requiring a venous valve;

B. forming an outlet transition region from said autologous vein segment, said outlet transition region having a tapered tubular shape with an outlet transition lumen and extending from said tubular conduit outlet end to said autologous vein requiring a venous valve.