Prosthetic heart valves
Prosthetic heart valves having a conical shaped base valve structure formed from collagenous mammalian tissue and an expandable stent structure. The base valve structure includes a plurality of elongated ribbon members that are positioned proximate each other in a joined relationship, wherein the elongated ribbon members are positioned adjacent each other and form a plurality of fluid flow modulating regions that open when fluid into and through the base valve structure exhibits a positive pressure relative to the exterior pressure, i.e., a positive pressure differential, wherein the fluid is allowed to be transmitted out of the base valve structure, and transition to a closed configuration when the pressure differential between the interior valve pressure and exterior pressure reduces, wherein the fluid is restricted from flowing out of the base valve structure. The expandable stent structure includes a plurality of tethers adapted to pierce cardiovascular tissue and, thereby, position the base valve structure and, thereby, prosthetic valves formed therewith on said heart valve annulus.
1. A prosthetic valve for modulating fluid flow through a cardiovascular structure during cardiac cycles of a heart, comprising:
a base valve structure and an expandable stent structure,
said base valve structure comprising collagenous tissue derived from a first mammalian tissue source,
said base valve structure further comprising an internal region, an open proximal valve annulus engagement end and a distal valve structure end, said open proximal valve annulus engagement end being configured and adapted to engage a heart valve annulus, receive said fluid flow therein and direct said fluid flow into said internal region of said base valve structure,
said base valve structure further comprising a plurality of elongated ribbon members that extend from said open proximal valve annulus engagement end to said distal valve structure end, 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 structure, 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 flow modulating regions,
said distal ends of said plurality of elongated ribbon members being positioned proximate each other in a constrained relationship, wherein said fluid flow through said distal ends of said plurality of elongated ribbon members and, thereby, said base valve structure is restricted,
said plurality of elongated ribbon members being configured and adapted to deflect outwardly when said open proximal valve annulus engagement end of said base valve structure directs said fluid flow into said internal region of said base valve structure and said fluid flow comprises a positive fluid pressure, whereby a first pressure differential between first valvular pressure in said internal region of said base valve structure relative to first external pressure exerted on said base valve structure is generated, wherein each of said plurality of flow modulating regions transitions from a restricted fluid flow configuration to an open fluid flow configuration and allows said fluid flow to be transmitted through said plurality of flow modulating regions and, thereby, through and out of said base valve structure,
said plurality of elongated ribbon members being further configured and adapted to deflect inwardly when said first pressure differential transitions to a second pressure differential between second valvular pressure in said internal region of said base valve structure relative to second external pressure exerted on said base valve structure, said second pressure differential being lower than said first pressure differential, wherein each of said plurality of flow modulating regions transitions from said open fluid flow configuration to said restricted fluid flow configuration and restricts said fluid flow through said plurality of flow modulating regions and, thereby, through and out of said base valve structure,
said expandable stent structure being positioned in said internal region of said base valve structure,
said expandable stent structure comprising a plurality of tethers adapted to pierce cardiovascular tissue and, thereby, position said base valve structure on said heart valve annulus,
wherein said stent structure comprises a shape-memory alloy, and
wherein said prosthetic valve is adapted to evert to an everted configuration.
2. The prosthetic valve of claim 1 , wherein said first 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 fetal tissue from any mammalian organ.
3. The prosthetic valve of claim 1 , wherein said first mammalian tissue source is devoid of xenogeneic antigens.
4. The prosthetic valve of claim 1 , wherein said collagenous tissue comprises a first pharmacological agent.
5. The prosthetic valve of claim 4 , wherein said first pharmacological agent is selected from the group consisting of an antibiotic, anti-viral agent, analgesic, anti-inflammatory, anti-neoplastic, anti-spasmodic, and anticoagulant and antithrombotic.
6. The prosthetic valve of claim 5 , wherein said antibiotic is selected from the group consisting of aminoglycosides, cephalosporins, chloramphenicol, clindamycin, erythromycins, fluoroquinolones, macrolides, azolides, metronidazole, penicillin, tetracyclines, trimethoprim-sulfamethoxazole, gentamicin and vancomycin.
7. The prosthetic valve of claim 5 , wherein said anti-inflammatory is selected from the group consisting of dexamethasone, betamethasone and prednisolone.
8. The prosthetic valve of claim 1 , wherein said shape-memory alloy comprises a nickel-titanium (Ni—Ti) alloy.
9. The prosthetic valve of claim 1 , wherein said prosthetic valve is further adapted to compress to a pre-deployment reduced size tubular configuration when in said everted configuration, whereby said prosthetic valve can be placed in and slidably translated through a percutaneous valve delivery apparatus and, thereby, delivered therewith to said heart valve annulus.
10. The prosthetic valve of claim 1 , wherein said stent structure comprises an outer coating.
11. The prosthetic valve of claim 10 , wherein said outer coating comprises an immunomodulating compound.
12. The prosthetic valve of claim 11 , wherein said immunomodulating compound comprises a polysaccharide selected from the group consisting of a glycosaminoglycan, dextran, alginate and chitosan.
13. The prosthetic valve of claim 11 , wherein said immunomodulating compound comprises a high molecular weight hyaluronic acid (HMW-HA).
14. The prosthetic valve of claim 10 , wherein said outer coating comprises an extracellular matrix (ECM) composition comprising acellular ECM derived from a second mammalian tissue source.
15. The prosthetic valve of claim 14 , wherein said second mammalian tissue source is selected from the group consisting of small intestine submucosa (SIS), urinary bladder submucosa (UBS), stomach submucosa (SS), heart tissue, mesothelial tissue, placental tissue and omentum tissue.
16. The prosthetic valve of claim 14 , wherein said ECM composition is in the form of an expandable composition.
17. The prosthetic valve of claim 10 , wherein said outer coating comprises a second pharmacological agent selected from the group consisting of desoximetasone, sirolimus, cyclosporine and prednisolone.