Bifurcated biological pulmonary valved conduit

• US 7,022,134 B1
• Filed: 06/28/2000
• Issued: 04/04/2006
• Est. Priority Date: 02/18/1999
• Status: Expired due to Term

• Current Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Quijano, Rodolfo C., Loya, Robert
• Primary Examiner(s): Pellegrino, Brian E.
• Application Number:
  US09/605,118
• Time in Patent Office: 2,106 Days
• Field of Search: 623/1.24, 623/1.1, 623/1.35, 623/1.3, 623/1.31, 600/36, 606/8, 606/153
• 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 2002/065 Y-shaped blood vessels

Abstract

The present invention comprises a pulmonary valved conduit that permits inflow diameters greater than about 22 mm while still maintaining the advantages of a naturally-formed biological valved conduit. Specifically, the present invention comprises a valved vascular prosthetic having an inflow conduit comprising a manifold formed from the sealed attachment of at least two venous valvular conduits.

Claims

1. A vascular prosthetic comprising:

at least two chemically fixed biological tissue valvular conduits, each of said conduits having an angular sectioned inflow end and an outflow end and a valve of chemically fixed biological tissue housed therein;

an inflow conduit having a large diameter cross-sectional area and a smooth inner lumen;

a seam, the seam comprising a plurality of single pass stitches, the seam on the angular sectioned inflow ends to attach the inflow ends to each other to define the inflow conduit, the smooth inner lumen oriented at an angle of less than 30 degrees to each of the at least two valvular conduit outflow ends, the inflow conduit positioned upstream of each of said valves.

2. The vascular prosthetic of claim 1 wherein the inflow conduit is suitable for attachment to a heart to receive blood from the right ventricle.

3. The vascular prosthetic of claim 1 wherein-at least one outflow end is suitable for attachment to a pulmonary trunk.

4. The vascular prosthetic of claim 1 wherein the outflow ends are suitable for attachment to first and second pulmonary arteries.

5. The vascular prosthetic of claim 1 wherein the valve of each valvular conduit opens at pressures as low as about 1 mm Hg and remains sealably closed so as to withstand backflow pressures greater than about 200 mm Hg.

6. The vascular prosthetic of claim 1 wherein the cross-sectional area of the inflow end of the vascular prosthetic is greater than about 22 mm.

7. The vascular prosthetic of claim 1 wherein the cross-sectional area of the inflow end of the prosthetic is greater than about 28 mm.

8. The vascular prosthetic of claim 1 wherein the fixed tissue conduits are fixed by an aldehyde.

9. The vascular prosthetic of claim 1 wherein the fixed tissue conduits are fixed by a polyepoxy compound.

10. A vascular prosthetic comprising:

a “

Y”

shaped conduit of fixed biological tissue having a large diameter inflow conduit, a bifurcated outflow conduit comprising two valvular conduit outflow ends and an integral valve disposed in each valvular conduit outflow ends, the pulmonary valved conduit formed from chemically fixed biological tissue, wherein each of said valvular conduits ends is joined at a seam forming the inflow conduit, the seam including a plurality of stitches forming a smooth inner lumen along the large diameter inflow conduit, the smooth inner lumen in fluid communication across the integral valves with the flow path in the valvular conduit outflow ends at an angle of −

transition less than 15 degrees from said inflow conduit to either of the valvular conduit outflow ends, the large diameter inflow conduit with a cross-sectional area larger than the cross-sectional area of either of the two valvular conduit outflow ends forming the “

Y”

shape.

11. The vascular prosthetic of claim 10 wherein the single inflow end is suitable for attachment to a heart to receive blood from the right ventricle.

12. The vascular prosthetic of claim 10 wherein the valvular conduits comprise first and second outflow ends, wherein at least one outflow end is suitable for attachment to a pulmonary trunk.

13. The vascular prosthetic of claim 12 wherein the first and second outflow ends are suitable for attachment to first and second pulmonary arteries.

14. The vascular prosthetic of claim 10 wherein the valve of each valvular conduit opens at pressures as low as about 1 mm Hg and remains sealably closed so as to withstand backflow pressures greater than about 200 mm Hg.

15. The vascular prosthetic of claim 10 wherein the cross-sectional area of the inflow end of the vascular prosthetic is greater than about 22 mm.

16. The vascular prosthetic of claim 10 wherein the cross-sectional area of the inflow end of the vascular prosthetic is greater than about 28 mm.

17. The vascular prosthetic of claim 10 wherein the stitches are formed in a single pass.

18. The vascular prosthetic of claim 10 wherein the fixed tissue conduits are fixed by an aldehyde.

19. The vascular prosthetic of claim 10 wherein the fixed tissue conduits are fixed by a polyepoxy compound.

20. A vascular prosthetic comprising:

an inflow conduit comprising a manifold formed from the attachment of two donor valved blood vessels, the attachment including a plurality of stitches forming a smooth inner lumen, each of said two blood vessels housing a biological valve integral therewith, each blood vessel configured to permit the flow of blood therethrough by the valve opening at a relatively low pressure and configured to prevent the backflow of blood therethrough by the valve closing so as to withstand relatively high pressures, said manifold formed at an angle of transition of the blood flow therethrough that is less than 30 degrees upstream of the biological valves so as not to interfere with the effective operation of the biological valves, the inflow conduit with a cross-sectional area larger than the cross-sectional area of either of the inflow ends of each of the donor blood vessels, and an outflow conduit positioned downstream of each of the biological valves.

21. The vascular prosthetic of claim 20 wherein the inflow conduit is suitable for attachment to a heart to receive blood from the right ventricle.

22. The vascular prosthetic of claim 20 wherein the donor blood vessels comprise first and second outflow ends, wherein at least one outflow end suitable for attachment to a pulmonary trunk.

23. The vascular prosthetic of claim 22 wherein the first and second outflow ends are suitable for attachment to first and second pulmonary arteries.

24. The vascular prosthetic of claim 20 wherein the valve of each donor blood vessel opens at pressures as low as about 1 mm Hg and remains sealably closed so as to withstand backflow pressures greater than about 200 mm Hg.

25. The vascular prosthetic of claim 20 wherein the cross-sectional area of the inflow conduit of the vascular prosthetic is greater than about 22 mm.

26. The vascular prosthetic of claim 20 wherein the cross-sectional area of the inflow conduit of the vascular prosthetic is greater than about 28 mm.

27. The vascular prosthetic of claim 20 wherein the plurality of donor blood vessels are chemically fixed biological tissue.

28. The vascular prosthetic of claim 27 wherein the plurality of donor blood vessels are fixed by an aldehyde.

29. The vascular prosthetic of claim 20 wherein the stitches are formed in a single pass.

30. The vascular prosthetic of claim 27 wherein the plurality of donor blood vessels are fixed by a polyepoxy compound.

31. The prosthetic of claim 20 wherein the plurality of donor blood vessels each comprise a vein segment.

32. The prosthetic of claim 31 wherein the plurality of donor blood vessels each comprise the jugular vein of a donor quadruped or marsupial.

33. The prosthetic of claim 32 wherein the valved blood vessels each comprise the jugular vein of a donor caprine, cervine, canine, ovine, bovine, equine or marsupial.

34. A vascular prosthetic comprising:

two chemically fixed biological tissue valvular conduits, each of said conduits having an angular sectioned inflow end and an outflow end and a valve of chemically fixed biological tissue housed therein, each of said conduits comprising the jugular vein of a donor quadruped or marsupial;

wherein each of said conduits is joined at the angular sectioned inflow ends by stitches to form a single inflow end having a smooth inner lumen with a single inflow end cross-sectional area larger than the cross-sectional area of any of the inflow ends of said valvular conduits, the joinder providing an angle of transition of the blood flow through the single inflow end and into the outflow ends that is less than 30 degrees.

35. The vascular prosthetic of claim 34 wherein the single inflow end is suitable for attachment to a heart to receive blood from the right ventricle.

36. The vascular prosthetic of claim 34 wherein the valvular conduits comprise first and second outflow ends, wherein at least one outflow end is suitable for attachment to a pulmonary trunk.

37. The vascular prosthetic of claim 34 wherein the valvular conduits comprise first and second outflow ends that are suitable for attachment to first and second pulmonary arteries.

38. The vascular prosthetic of claim 34 wherein the valve of each valvular conduit opens at pressures as low as about 1 mm Hg and remains sealably closed so as to withstand backflow pressures greater than about 200 mm Hg.

39. The vascular prosthetic of claim 34 wherein the cross-sectional area of the inflow end of the vascular prosthetic is greater than about 22 mm.

40. The vascular prosthetic of claim 34 wherein the cross-sectional area of the inflow end of the vascular prosthetic is greater than about 28 mm.

41. The vascular prosthetic of claim 34 wherein the fixed tissue conduits are fixed by an aldehyde.

42. The vascular prosthetic of claim 34 wherein the fixed tissue conduits are fixed by a polyepoxy compound.