Laminated sealing member for prosthetic heart valve
First Claim
1. An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic valve comprising:
- an annular frame having an inflow end and an outflow end;
a leaflet structure positioned within the frame and secured thereto; and
a laminate sealing member comprising an inner layer positioned on the inside of the frame and an outer layer positioned on the outside of the frame, the outer layer including an inflow end portion comprising an inflow edge, an outflow end portion comprising an outflow edge, and a main body portion extending between the inflow end portion and the outflow end portion, the inflow end portion of the outer layer extending from the inflow end of the frame, the inner and outer layers being heat-bonded together to form a main portion of the laminate sealing member that encapsulates corresponding portions of the frame;
wherein the inflow end portion of the outer layer is folded to form a cuff adjacent the inflow end of the frame such that the outer layer forms a fold line at an upstream-most end of the outer layer and doubles back on the outside of the frame so that the cuff extends from the fold line in a downstream direction along an outer surface of the main body portion of the outer layer and forms a double layer on the exterior of the frame, and wherein the inflow edge of the outer layer is secured to the main body portion of the outer layer downstream of the fold line.
1 Assignment
0 Petitions
Accused Products
Abstract
The present disclosure relates to laminated sealing members for prosthetic valves and methods of making the same. In a representative embodiment, an implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration comprises an annular frame having an inflow end and an outflow end, a leaflet structure positioned within the frame and secured thereto, and a laminate sealing member comprising an encapsulating material. The laminate sealing member has a main portion that encapsulates at least a portion of the frame and an end portion extending from the inflow end of the frame, and the end portion of the laminate sealing member is folded to form a cuff adjacent the inflow end of the frame and secured to the main portion of the laminate sealing member.
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Citations
20 Claims
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1. An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic valve comprising:
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an annular frame having an inflow end and an outflow end; a leaflet structure positioned within the frame and secured thereto; and a laminate sealing member comprising an inner layer positioned on the inside of the frame and an outer layer positioned on the outside of the frame, the outer layer including an inflow end portion comprising an inflow edge, an outflow end portion comprising an outflow edge, and a main body portion extending between the inflow end portion and the outflow end portion, the inflow end portion of the outer layer extending from the inflow end of the frame, the inner and outer layers being heat-bonded together to form a main portion of the laminate sealing member that encapsulates corresponding portions of the frame; wherein the inflow end portion of the outer layer is folded to form a cuff adjacent the inflow end of the frame such that the outer layer forms a fold line at an upstream-most end of the outer layer and doubles back on the outside of the frame so that the cuff extends from the fold line in a downstream direction along an outer surface of the main body portion of the outer layer and forms a double layer on the exterior of the frame, and wherein the inflow edge of the outer layer is secured to the main body portion of the outer layer downstream of the fold line. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method of making a prosthetic heart valve, comprising:
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positioning an inner layer about a mandrel; positioning an annular radially expandable and collapsible frame over the inner layer such that the inner layer is positioned on the inside of the frame, the frame having an inflow end and an outflow end; positioning an outer layer over the frame, the outer layer including an inflow end portion comprising an inflow edge, an outflow end portion comprising an outflow edge, and a main body portion extending between the inflow end portion and the outflow end portion, the outer layer being positioned such that the outer layer is on the outside of the frame, and such that the inflow end portion of the outer layer extends beyond the inflow end of the frame; 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 a main portion of the laminate sealing member; folding the inflow end portion of the outer layer to form a cuff adjacent the inflow end of the frame such that the outer layer forms a fold line at an upstream-most end of the outer layer and doubles back on the outside of the frame so that the cuff extends from the fold line in a downstream direction along an outer surface of the main body portion of the outer layer and forms a double layer on the exterior of the frame; securing the inflow edge of the outer layer to the main body portion of the outer layer downstream of the fold line; positioning a leaflet structure within the frame; and securing the leaflet structure to the frame. - View Dependent Claims (13, 14, 15, 16, 17, 18)
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19. A transcatheter heart valve, comprising:
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a radially expandable frame having an inflow end, an outflow end, and a laminate sealing member comprising; a non-fabric inner layer positioned inside of the frame; a non-fabric outer layer positioned outside of the frame, the non-fabric outer layer comprising an inflow end portion including an inflow edge, an outflow end portion comprising an outflow edge, and a main body portion extending between the inflow end portion and the outflow end portion, the inflow end portion of the non-fabric outer layer extending beyond the inflow end of the frame; and a fabric layer positioned 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 the inflow end portion of the non-fabric outer layer is folded to form a cuff adjacent the inflow end of the frame such that the non-fabric outer layer forms a fold line at an upstream-most end of the outer layer and doubles back on the outside of the frame so that the cuff extends from the fold line in a downstream direction along an outer surface of the main body portion of the non-fabric outer layer and forms a double layer on the exterior of the frame, and wherein the inflow edge of the non-fabric outer layer is secured to the main body portion of the non-fabric outer layer downstream of the fold line. - View Dependent Claims (20)
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Specification