Prosthetic Venous Valves

A prosthetic venous valve for modulating fluid flow through a venous vessel, comprising:

• a base valve member and a biomaterial delivery construct,
• said base valve member comprising a first ECM composition comprising first acellular ECM derived from a first mammalian tissue source,
• said base valve member further comprising an internal region, an open proximal valve member end and a distal valve member end, said open proximal valve member end being configured and adapted to receive an antegrade blood flow therein and direct said antegrade blood flow into said internal region of said base valve member,
• said base valve member further comprising a plurality of elongated ribbon members that extend from said open proximal valve member end of said base valve member to said distal valve member end of said base valve member, each of said plurality of elongated ribbon members comprising first and second edge regions and proximal and distal ends, said plurality of elongated ribbon members being positioned circumferentially about said base valve member, wherein said first edge regions of said plurality of elongated ribbon members are positioned proximate said second edge regions of said plurality of elongated ribbon members and form a plurality of contiguous ribbon edge regions, said plurality of contiguous ribbon edge regions forming a plurality of flow modulating regions,
• said distal ends of said plurality of ribbon members being positioned proximate each other in a constrained relationship, wherein said base valve member comprises a conical shaped region and, when first antegrade blood flow is directed into said internal region of said base valve member, said first antegrade blood flow through the constrained distal ends of the plurality of elongated ribbon members is restricted,
• said plurality of elongated ribbon members being configured and adapted to deflect outwardly when said first antegrade blood flow is directed into said internal region of said base valve member and a negative hydrostatic pressure gradient is generated proximate said plurality of elongated ribbon members, whereby each of said plurality of flow modulating regions transition from a restricted fluid flow configuration to an open fluid flow configuration and allows said first antegrade blood flow to be transmitted through and out of said base valve member and, thereby, into and through said venous vessel,
• said plurality of elongated ribbon members being further configured and adapted to deflect inwardly when said first antegrade blood flow is directed into said internal region of said base valve member and a positive hydrostatic pressure is generated proximate the plurality of elongated ribbon members, whereby each of said flow modulating regions transitions from said open fluid flow configuration to said restricted fluid flow configuration and restricts retrograde blood flow through said base valve member,
• said biomaterial delivery construct comprising an elongated tubular structure, said elongated structure comprising an inner lumen therethrough sized and configured to receive and seat said open proximal valve member end of said base valve member therein,
• said biomaterial delivery construct sized, configured and adapted to be disposed proximate a luminal wall of a venous vessel,
• said biomaterial delivery construct comprising a second ECM composition comprising second acellular ECM derived from a second mammalian tissue source and an outer coating comprising poly(glycerol sebacate) (PGS),
• said base valve member and said biomaterial delivery construct being adapted to remodel and jointly induce remodeling of damaged cardiovascular tissue associated with said venous vessel and regeneration of new cardiovascular tissue when said biomaterial delivery construct is disposed proximate said luminal wall of said venous vessel.