Adaptable prosthetic tissue valves
Prosthetic valves that include conical shaped base valve members having an annular engagement end, a closed distal end region that restricts fluid flow therethrough, and a plurality of elongated ribbon members, which transition from an open fluid flow configuration to a closed fluid flow configuration in response to expansion and contraction of the base valve member, and a support structure that is configured and adapted to exert retaining forces on the annular engagement ends of the base valve members, whereby the support structure (i) conforms to the shape of the annular engagement ends of the base valve members, (ii) securely positions the annular engagement ends of the base valve members adjacent to and, thereby, in contact with a valve annulus, whereby the annular engagement ends of the base valve members conform to the shape of the valve annulus, and (iii) the annular engagement ends of the base valve members adapt to at least one fluctuation in the configuration and/or dimension of the valve annulus, whereby the annular engagement ends of the base valve members maintain contact therewith.
1. An adaptable prosthetic valve for modulating fluid flow through an atrioventricular (AV) valve annulus region during cardiac cycles of a heart, said AV valve annulus region comprising a plurality of AV valve annulus configurations and a plurality of AV valve annulus dimensions, said prosthetic valve comprising:
a base valve member and an internal support structure, said base valve member comprising a continuous sheet member,
said base valve member comprising mammalian-based tissue from a mammalian tissue source,
said base valve member comprising an internal lumen adapted to transmit fluid flow therethrough, a proximal annular engagement end and a distal end,
said proximal annular engagement end being configured to engage said AV valve annulus region,
said proximal annular engagement end being further configured and adapted to transition from a first proximal annular engagement end operative configuration to a second proximal annular engagement end operative configuration, and a first proximal annular engagement end operative dimension and a second proximal annular engagement end operative dimension,
said first proximal annular engagement end operative configuration conforming to a first AV valve annulus region configuration of said plurality of AV valve annulus configurations, said first proximal annular engagement end operative dimension conforming to a first AV valve annulus region dimension of said plurality of AV valve annulus dimensions, said second proximal annular engagement end operative configuration conforming to a second AV valve annulus region configuration of said plurality of AV valve annulus configurations, and said second proximal annular engagement end operative dimension conforming to a second AV valve annulus region dimension of said plurality of AV valve annulus dimensions,
said first proximal annular engagement end operative configuration conforming to said first AV valve annulus region configuration, said first proximal annular engagement end operative dimension conforming to said first AV valve annulus region dimension, said second proximal annular engagement end operative configuration conforming to said second AV valve annulus region configuration, and said second proximal annular engagement end operative dimension conforming to said second AV valve annulus region dimension,
said proximal annular engagement end of the base valve member comprising a plurality of equally spaced ribbon members,
each of said plurality of ribbon members comprising proximal and distal ends, a first edge region extending from said proximal end of each of said plurality of ribbon members to said distal end of each of said plurality of ribbon members and a second edge region extending from said proximal end of each of said plurality of ribbon members to said distal end of each of said plurality of ribbon members,
said plurality of ribbon members being positioned circumferentially about said proximal annular engagement end and extending toward said distal end of said base valve member, wherein said first edge regions of said plurality of ribbon members are positioned proximate said second edge regions of said plurality of ribbon members, wherein a plurality of fluid flow modulating regions is formed between adjacent ribbons of said plurality of ribbon members,
said distal ends of said plurality of ribbon members being disposed proximate each other in a joined relationship, wherein said fluid flow through said distal end of said base valve member is restricted while said fluid flow is allowed to be transmitted through said plurality of fluid flow modulating regions when in an open position,
said base valve member, when said proximal annular engagement end of said base valve member is engaged to said AV valve annulus region, being configured to transition from an expanded position, wherein said base valve member receives said fluid flow therein and said fluid flow exhibits a first fluid flow pressure, to a collapsed position when said fluid flow exhibits a second fluid flow pressure, said second fluid flow pressure being lower than said first fluid flow pressure,
said plurality of fluid flow modulating regions being configured to transition from an open fluid flow position when said base valve member is in said expanded position, wherein said plurality of fluid flow modulating regions allow said fluid flow to be transmitted through said base valve member, to a closed fluid flow position when said base valve member is in said collapsed position, wherein said plurality of fluid flow modulating regions restrict said fluid flow through said base valve member,
said support structure comprising a base and a plurality of elongated support members having proximal and distal ends, said base being disposed proximate said distal end of said base valve member, said support structure comprising support members extending from said base to a ribbon member region distal to the proximal ends of the ribbon members,
a proximal end of said support structure comprising a discontinuous, cross-linked circumferential proximal end,
said plurality of elongated support members being adapted to exert an outwardly projecting retaining force on the proximal annular engagement end, whereby said support structure positions said proximal annular engagement end of said base valve member adjacent to and, thereby, in contact with said AV valve annulus region and induces said transition of said proximal annular engagement end of said base valve member from said first proximal annular engagement end operative configuration to said second proximal annular engagement end operative configuration, and said first proximal annular engagement end operative dimension to said second proximal annular engagement end operative dimension in response to a transition of said first AV valve annulus region configuration to said second AV valve annulus region configuration and said first AV valve annulus region dimension to said second AV valve annulus region dimension, wherein said proximal annular engagement end of said base valve member remains in contact with said AV valve annulus region.
2. The prosthetic valve of claim 1 , wherein said mammalian tissue source is selected from the group consisting of the heart, small intestine, large intestine, stomach, lung, liver, kidney, pancreas, peritoneum, placenta, amniotic membrane, umbilical cord, bladder, prostate, and any fetal tissue from any mammalian organ.
3. The prosthetic valve of claim 2 , wherein said mammalian-based tissue is devoid of xenogeneic antigens.
4. The prosthetic valve of claim 2 , wherein said mammalian-based tissue comprises acellular ECM.
5. The prosthetic valve of claim 2 , wherein said mammalian-based tissue comprises pericardium tissue.
6. The prosthetic valve of claim 1 , wherein said mammalian-based tissue further comprises at least one exogenously added biologically active agent.
7. The prosthetic valve of claim 6 , wherein said biologically active agent comprises a cell selected from the group consisting of a human embryonic stem cell, fetal cardiomyocyte, myofibroblast, and mesenchymal stem cell.
8. The prosthetic valve of claim 6 , wherein said biologically active agent comprises a growth factor selected from the group consisting of a transforming growth factor-alpha (TGF-α), transforming growth factor-beta (TGF-β), fibroblast growth factor-2 (FGF-2), and vascular endothelial growth factor (VEGF).
9. The prosthetic valve of claim 1 , wherein said mammalian-based tissue further comprises a pharmacological agent.
10. The prosthetic valve of claim 9 , wherein said pharmacological agent comprises an agent selected from the group consisting of an antibiotic, anti-viral agent, analgesic, anti-inflammatory, anti-neoplastic, anti-spasmodic, anti-coagulant and anti-thrombotic.
11. The prosthetic valve of claim 1 , wherein said support structure comprises a shape memory alloy.
12. The prosthetic valve of claim 11 , wherein said shape memory alloy comprises a nickel-titanium alloy.