Methods of making encapsulated heart valves
First Claim
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1. A method for making an implantable prosthetic heart valve, comprising:
- forming a subassembly of the prosthetic heart valve comprising a radially collapsible and expandable tubular frame, the frame having an inlet end and outlet end, the frame comprising a plurality of connected struts defining cells and openings therebetween, and an annular fabric skirt positioned adjacent the frame;
forming a first tubular covering member on a mandrel by a process of electrospinning;
placing the subassembly over the first tubular covering member on the mandrel so that the first tubular covering member at least partly extends within the subassembly;
forming a second tubular covering member over the subassembly on the first tubular covering member on the mandrel by a process of electrospinning so that the second tubular covering member at least partly covers the subassembly and is coextensive with the first tubular covering member;
applying pressure to force the second tubular covering member and the first tubular covering member into contact with each other;
heating the first and second tubular covering members so that they fuse together to form a monolithic covering that at least partially encapsulates the subassembly and thereby secures the fabric skirt to the annular frame; and
suturing valvular leaflets to the monolithic covering and the subassembly, the leaflets being configured to permit blood flow in a first direction through the heart valve and block blood flow through the heart valve in a second direction, opposite the first direction.
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Abstract
The present disclosure concerns embodiments of implantable prosthetic devices, and in particular, implantable prosthetic valves, and methods for making such devices. In one aspect, a prosthetic device includes encapsulating layers that extend over a fabric layer and secure the fabric layer to another component of the device. In particular embodiments, the prosthetic device comprises a prosthetic heart valve, and can be configured to be implanted in any of the native heart valves. In addition, the prosthetic heart valve can be, for example, a transcatheter heart valve, a surgical heart valve, or a minimally-invasive heart valve.
388 Citations
20 Claims
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1. A method for making an implantable prosthetic heart valve, comprising:
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forming a subassembly of the prosthetic heart valve comprising a radially collapsible and expandable tubular frame, the frame having an inlet end and outlet end, the frame comprising a plurality of connected struts defining cells and openings therebetween, and an annular fabric skirt positioned adjacent the frame; forming a first tubular covering member on a mandrel by a process of electrospinning; placing the subassembly over the first tubular covering member on the mandrel so that the first tubular covering member at least partly extends within the subassembly; forming a second tubular covering member over the subassembly on the first tubular covering member on the mandrel by a process of electrospinning so that the second tubular covering member at least partly covers the subassembly and is coextensive with the first tubular covering member; applying pressure to force the second tubular covering member and the first tubular covering member into contact with each other; heating the first and second tubular covering members so that they fuse together to form a monolithic covering that at least partially encapsulates the subassembly and thereby secures the fabric skirt to the annular frame; and suturing valvular leaflets to the monolithic covering and the subassembly, the leaflets being configured to permit blood flow in a first direction through the heart valve and block blood flow through the heart valve in a second direction, opposite the first direction. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification