Laminated sealing member for prosthetic heart valve

A transcatheter heart valve, comprising:

• a radially expandable frame having an inflow end, an outflow end, and defining a longitudinal axis along a lumen of the transcatheter heart valve when the transcatheter heart valve is radially expanded;
• and
• a laminate sealing member comprising:
• a non-fabric inner layer disposed inside of the frame;
• a non-fabric outer layer disposed outside of the frame;
• and
• a fabric layer disposed between the non-fabric inner layer and the non-fabric outer layer, the non-fabric inner and outer layers being heat-bonded to one another such that the fabric layer and at least a portion of the frame are encapsulated therebetween;
• wherein, on the outside of the frame, the non-fabric outer layer extends along the longitudinal axis in an upstream direction and doubles back toward the outflow end of the frame at a fold line to form a cuff, and an edge portion of the non-fabric outer layer is secured to the non-fabric outer layer downstream of the fold line such that the cuff forms an inflow end of the laminate sealing member.

A method of making a prosthetic heart valve, comprising:

• positioning an inner layer about a mandrel;
• positioning an annular frame over the inner layer, the frame being radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the frame having an inflow end and an outflow end, and defining a longitudinal axis along a lumen of the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration;
• positioning an outer layer over the frame such that an edge portion of the outer layer extends beyond the inflow end of the frame along the longitudinal axis;
• heat-bonding the inner and outer layers to form a monolithic laminate sealing member such that at least a portion of the frame is encapsulated within the laminate sealing member;
• folding the edge portion of the outer layer such that the outer layer extends along the longitudinal axis in an upstream direction and doubles back on the outside of the frame toward the outflow end of the frame at a fold line to form a cuff;
• securing the edge portion of the outer layer to the outer layer downstream of the fold line such that the cuff forms an inflow end of the laminate sealing member;
• positioning a leaflet structure within the frame;
• and
• securing the leaflet structure to the frame.