Prosthetic heart valves
Prosthetic heart valves having a conical shaped base valve structure formed from collagenous mammalian tissue. 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.
1. A prosthetic valve for modulating fluid flow through a cardiovascular structure during cardiac cycles of a heart, comprising:
a base valve member comprising crosslinked mammalian collagenous tissue, said crosslinked mammalian collagenous tissue comprising crosslinked pericardium tissue,
said crosslinked pericardium tissue comprising an elastic phase slope (E) in the range of 0.3 MPa to 0.5 MPa,
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 engage an atrioventricular (AV) valve annulus, receive said fluid flow therein and direct first fluid of said fluid flow into said internal region of said base valve member, said open proximal valve member end defining an open valve inlet end comprising a first open area,
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 elongated ribbon members being positioned proximate each other in a constrained relationship, wherein said base valve member comprises a conical shaped region and said fluid flow through said distal ends of said plurality of elongated ribbon members is restricted,
said plurality of elongated ribbon members being configured and adapted to deflect outwardly, whereby each of said plurality of flow modulating regions transitions from a restricted fluid flow configuration to an open fluid flow configuration and allows said first fluid to be transmitted through and out of said base valve member, when said base valve member is engaged to said AV valve annulus, said open proximal valve member end of said base valve member directs said first fluid into said internal region of said base valve member and said first fluid comprises a first positive fluid pressure, whereby a first positive pressure differential between first valvular pressure in said internal region of said base valve member relative to first external pressure exerted on said conical shaped region of said base valve member is generated,
said plurality of elongated ribbon members being further configured and adapted to deflect inwardly, whereby each of said plurality of flow modulating regions transitions from said open fluid flow configuration to said restricted fluid flow configuration and restricts said transmission of said first fluid through and out of said base valve member when said first positive pressure differential transitions to a second pressure differential between second valvular pressure in said internal region of said base valve member relative to second external pressure exerted on said conical shaped region of said base valve member, said second pressure differential being lower than said first positive pressure differential.
2. The prosthetic valve of claim 1 , wherein said crosslinked pericardium tissue comprises a tensile strength in the range of 9 MPa to 12 MPa.
3. The prosthetic valve of claim 1 , wherein said plurality of flow modulating regions in said open fluid flow configuration define a fluid outlet area of said base valve member, said fluid outlet area of said base valve member being at least two times greater than said first open area of said open valve inlet end.
4. The prosthetic valve of claim 1 , wherein said crosslinked pericardium tissue comprises crosslinked bovine pericardium tissue.
5. The prosthetic valve of claim 1 , wherein said crosslinked pericardium tissue comprises a pharmacological agent.
6. The prosthetic valve of claim 5 , wherein said pharmacological agent comprises a pharmacological agent selected from the group consisting of desoximetasone, sirolimus, cyclosporine and prednisolone.
7. The prosthetic valve of claim 5 , wherein said pharmacological agent comprises a HMG-CoA reductase inhibitor selected from the group consisting of atorvastatin, cerivastatin, fluvastatin and lovastatin.
8. The prosthetic valve of claim 1 , wherein said crosslinked pericardium tissue is derived from pericardium tissue devoid of xenogeneic antigens.