Biological valve for venous valve insufficiency

Abstract

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 monocusp bioprosthetic valve for implantation into a host vein of a subject, the bioprosthetic valve comprising biological tissue from a xenogeneic source, the biological tissue comprising a single leaflet from a heart valve and a patch comprising tissue contiguous with the single leaflet. 
     
     
         2 . The monocusp bioprosthetic valve of  claim 1 , wherein the xenogeneic source is porcine. 
     
     
         3 . The monocusp bioprosthetic valve of  claim 1 , wherein the single leaflet is attached to the patch at natural margins of attachment. 
     
     
         4 . The monocusp bioprosthetic valve of  claim 1 , wherein the heart valve is an aortic valve. 
     
     
         5 . The monocusp bioprosthetic valve of  claim 4 , wherein the patch includes a segment of the aortic annulus. 
     
     
         6 . The monocusp bioprosthetic valve of  claim 4 , wherein the patch includes a portion of the aortic wall. 
     
     
         7 . The monocusp bioprosthetic valve of  claim 6 , wherein the patch includes the portion of the aortic wall defining a natural sinus for the leaflet. 
     
     
         8 . The monocusp bioprosthetic valve of  claim 4 , wherein the single leaflet is a noncoronary leaflet. 
     
     
         9 . The monocusp bioprosthetic valve of  claim 1 , wherein the patch has a generally rectangular shape. 
     
     
         10 . The monocusp bioprosthetic valve of  claim 1 , wherein the patch has a generally ovoid shape. 
     
     
         11 . The monocusp bioprosthetic valve of  claim 1 , wherein the patch extends circumferentially on either side of the leaflet so as to provide a region for attachment to the host vein. 
     
     
         12 . The monocusp bioprosthetic valve of  claim 1 , wherein the patch extends axially above and below the leaflet so as to provide a region for attachment to the host vein. 
     
     
         13 . The monocusp bioprosthetic valve of  claim 1 , wherein at least a portion of the patch is covered with a synthetic fabric. 
     
     
         14 . The monocusp bioprosthetic valve of  claim 1 , wherein the subject is human. 
     
     
         15 . A bioprosthetic valve for implantation into a host vein of a subject, the bioprosthetic valve consisting essentially of a single leaflet from a xenogeneic heart valve attached at natural margins of attachment to a patch of valve wall tissue from the xenogeneic heart valve. 
     
     
         16 . The bioprosthetic valve of  claim 15 , wherein the xenogeneic heart valve is porcine. 
     
     
         17 . The bioprosthetic valve of  claim 15 , wherein the patch extends circumferentially on either side of the leaflet to provide a region for attachment to the host vein. 
     
     
         18 . The bioprosthetic valve of  claim 15 , wherein the patch extends axially above and below the leaflet to provide a region for attachment to the host vein. 
     
     
         19 . The bioprosthetic valve of  claim 15 , wherein the xenogeneic heart valve is an aortic valve. 
     
     
         20 . The bioprosthetic valve of  claim 19 , wherein the leaflet is a noncoronary leaflet. 
     
     
         21 . A method of manufacturing a replacement venous valve for a subject, the method comprising:
 providing a xenogeneic heart valve, the heart valve having at least one leaflet and a valve wall, the heart valve having been subjected to a fixation treatment; and   excising a portion of the heart valve, the portion comprising at least a selected leaflet attached at natural margins of attachment to a patch of valve wall tissue, such that said excised portion comprises a single leaflet.   
     
     
         22 . The method of  claim 21 , wherein the xenogeneic heart valve is porcine. 
     
     
         23 . The method of  claim 21 , wherein the patch extends circumferentially on either side of the selected leaflet to provide a region for attachment to the host vein. 
     
     
         24 . The method of  claim 21 , wherein the patch extends axially above and below the selected leaflet to provide a region for attachment to the host vein. 
     
     
         25 . The method of  claim 21 , wherein the xenogeneic heart valve is an aortic valve. 
     
     
         26 . The method of  claim 25 , wherein the selected leaflet is a noncoronary leaflet. 
     
     
         27 . The method of  claim 21 , further comprising cutting through each natural commissure of the selected leaflet and shaving off tissue of any leaflets adjacent to the selected leaflet. 
     
     
         28 . The method of  claim 21 , wherein the subject is human. 
     
     
         29 . A method of treating a malfunctioning valve in a host vein of a subject, the method comprising:
 providing a replacement biological valve comprising a single leaflet from a xenogeneic heart valve attached at natural margins of attachment to a patch of contiguous tissue from the xenogeneic heart valve; and   inserting said replacement biological valve into said host vein.   
     
     
         30 . The method of  claim 29 , further comprising creating a fenestration in the host vein in the region of the malfunctioning valve, the fenestration having a shape generally corresponding to the patch. 
     
     
         31 . The method of  claim 30 , wherein the fenestration is created generally in the region of the malfunctioning valve. 
     
     
         32 . The method of  claim 30 , wherein the fenestration is created generally above the region of the malfunctioning valve. 
     
     
         33 . The method of  claim 30 , wherein the fenestration is created generally below the region of the malfunctioning valve. 
     
     
         34 . The method of  claim 30 , further comprising attaching the replacement biological valve to the host vein at the fenestration. 
     
     
         35 . The method of  claim 29 , further comprising removing at least one leaflet from the malfunctioning valve of the host vein. 
     
     
         36 . The method of  claim 29 , wherein the xenogeneic heart valve is a porcine aortic valve. 
     
     
         37 . The method of  claim 36 , wherein the single leaflet is a noncoronary leaflet. 
     
     
         38 . The method of  claim 29 , wherein the leaflet and patch have been subjected to a fixation treatment. 
     
     
         39 . The method of  claim 38 , wherein the fixation treatment includes exposing the leaflet and patch to glutaraldehyde solution. 
     
     
         40 . The method of  claim 29 , wherein the subject is human. 
     
     
         41 . A bioprosthetic valve comprising a plurality of monocusp bioprosthetic valves according to  claim 1 . 
     
     
         42 . The bioprosthetic valve of  claim 41 , wherein the plurality of monocusp bioprosthetic valves are configured to be implanted separately. 
     
     
         43 . The bioprosthetic valve of  claim 41 , wherein the plurality of monocusp bioprosthetic valves are attached together.