Biological valve for venous insufficiency
A bioprosthetic valve for repairing a deep venous insufficiency in a subject includes a single leaflet from a xenogeneic heart valve attached at natural margins of attachment to a patch of valve wall tissue. The patch may extend axially above and below the leaflet and circumferentially on either side of the leaflet to provide a region for attaching the patch to a fenestration in a host vein. A bioprosthetic valve may be manufactured by excising a portion of a xenogeneic heart valve including a single leaflet and contiguous wall tissue, and may further comprise shaving off excess leaflet tissue from adjacent leaflets. A method of replacing a malfunctioning venous valve in a subject includes providing a bioprosthetic valve as described above and inserting it to the host vein.
1. A method of manufacturing a replacement monocusp venous valve for a host vein of a subject, comprising:
modifying a porcine aortic xenogenic heart valve to excise leaflets from the xenogenic heart valve except for an aortic noncoronary leaflet and including a natural sinus of the xenogenic heart valve so that the natural sinus provides a spatial buffer between a free edge of the noncoronary leaflet and a valve wall that facilitates opening and closing of the noncoronary leaflet based on flow pressure through the valve; and
including natural margins of attachment with the noncoronary leaflet.
2. The method of claim 1 , further comprising the step of attaching a patch to said monocusp venous valve to form a monocusp venous valve that is generally rectangular in shape.
3. The method of claim 2 , wherein said patch is selected from porcine heart valve tissue.
4. The method of claim 2 , further comprises the step of subjecting said monocusp venous valve to crosslinking treatment.
5. The method of claim 4 , wherein the crosslinking treatment includes using a glutaraldehyde solution.
6. The method of claim 5 , wherein the glutaraldehyde solution is prepared using 0.1%-to 1.0% glutaraldehyde in a buffer selected form the group of phosphate, citrate buffer and combinations thereof, and is formulated to maintain pH at between 6.0 and 8.0.
7. The method of claim 2 , further comprises the step of subjecting said monocusp venous valve to sterilization process.
8. The method of claim 7 , wherein the sterilization process comprises the use of gamma irradiation.
9. The method of claim 2 , wherein the step of attaching said patch to said monocusp venous valve comprises the use of sutures.
10. The method of claim 2 , further comprising the step of measuring a thickness of the valve wall, measuring a thickness of the patch and selecting the valve wall and patch for attachment that have matching thicknesses.
11. The method of claim 2 , further comprising the step of measuring a thickness of the valve wall, measuring a thickness of the patch and reducing the thickness of said valve wall for attachment to match the thicknesses of said patch.
12. The method of claim 2 wherein the monocusp venous valve is selected to contain significant amounts of collagen and elastin with minimal smooth muscle tissue.
13. The method of claim 2 , further comprising attaching a backing liner, conduit or tube to said monocusp venous valve.
14. The method of claim 13 , further comprising suturing a backing liner, conduit or tube to said venous valve.
15. A replacement venous valve made in accordance with the method of claim 2 .
16. The method of claim 1 , further comprises the step of subjecting said monocusp venous valve to crosslinking treatment.
17. The method of claim 16 , wherein the crosslinking treatment includes using a glutaraldehyde solution.
18. The method of claim 17 , wherein the glutaraldehyde solution is prepared using 0.1%-to 1.0% glutaraldehyde in a buffer selected form the group of phosphate, citrate buffer and combinations thereof, and is formulated to maintain pH at between 6.0 and 8.0.
19. The method of claim 1 , further comprises the step of subjecting said monocusp venous valve to sterilization process.
20. The method of claim 19 , wherein the sterilization process comprises the use of gamma irradiation.
21. The method of claim 1 , wherein the monocusp venous valve is selected to contain significant amounts of collagen and elastin with minimal smooth muscle tissue.
22. The method of claim 1 , further comprising attaching a backing liner, conduit or tube to said monocusp venous valve.
23. The method of claim 22 , further comprising suturing a backing liner, conduit or tube to said venous valve.
24. The method of claim 1 , further comprising the step of attaching a patch to said valve wall to form a monocusp venous valve that is generally ovoid in shape.
25. The method of claim 1 , further comprising the step of attaching a patch to said monocusp venous valve to extend the valve wall longitudinally and laterally.
26. The method of claim 1 , further comprising the step of attaching a patch to said monocusp venous valve and trimming excess tissue to form a monocusp venous valve that is generally rectangular in shape.
27. The method of claim 26 , where said patch is attached to said monocusp venous valve using sutures.
28. A replacement venous valve device for a host vein in a subject, comprising the replacement venous valve manufactured by the method of claim 1 .