Prosthetic Cardiac Valve from Pericardium Material and Methods of Making Same

A prosthetic stented heart valve comprising:

• a. radially compressible and expandable tubular metal frame structure having a longitudinal axis and extending from an inflow end along the longitudinal axis to an outflow end along the longitudinal axis;
• and
• a valve segment comprising material layers that are formed into a generally tubular shape and provide a plurality of leaflet pockets, each leaflet pocket comprising a first material layer attached to a second material layer with the plural leaflet pockets arranged together in the generally tubular shape and providing a leaflet-defining pattern that is longitudinally spaced from the inflow end of the metal frame structure and that permits fluid flow from the inflow end of the metal frame structure through the leaflet-defining pattern and that prevents fluid flow back through the leaflet-defining pattern toward the inflow end of the metal frame structure, each leaflet pocket comprising an arcuate portion extending between first and second side edge portions and an open edge spaced longitudinally from the arcuate portion between the first and second side edge portions;
• wherein at least a portion of the valve segment is longitudinally positioned within the metal frame structure, and wherein the metal frame structure is attached to the first material layer of at least one leaflet pocket with the first material layer extending longitudinally at least to the inflow end of the metal frame structure.

A prosthetic stented heart valve comprising:

• a radially compressible and expandable tubular metal frame structure having a longitudinal axis and extending from an inflow end along the longitudinal axis to an outflow end along the longitudinal axis;
• and
• a valve segment comprising material layers providing a plurality of leaflets, the valve segment formed into a generally tubular shape, each leaflet comprising a first material layer and a second material layer secured to at least the first material sheet with the leaflets arranged together in the generally tubular shape and providing a leaflet-defining pattern that is longitudinally spaced from the inflow end of the metal frame structure and that permits fluid flow from the inflow end of the metal frame structure through the leaflet-defining pattern and that prevents fluid flow back through the leaflet-defining pattern toward the inflow end of the metal frame structure, each leaflet comprising first and second side edge portions, an arcuate portion extending between first and second side edge portions, and an open edge spaced from the arcuate portion;
• wherein at least a portion of the valve segment is longitudinally positioned between the first and second ends of the metal frame structure, and wherein the metal frame structure is attached to the first material sheet of at least one leaflet with the first material sheet extending longitudinally to the inflow end of the metal frame structure.