Frame with integral sewing cuff for prosthetic valves
Described embodiments are related to a prosthetic valve for surgical placement with a sewing cuff durably attached to a frame. The durability of the attachment is accomplished by sandwiching a fabric between the frame and a composite material. The fabric extends beyond the frame base to form a sewing cuff that is integral to a frame assembly. The sewing cuff facilitates tissue ingrowth while tissue ingrowth is discouraged elsewhere around the frame.
1. A method of making a frame assembly for a prosthetic valve, comprising:
coupling a frame defining a tubular shape to a fabric having fabric pores, the fabric defining a fabric frame portion and a sewing cuff portion opposite the fabric frame portion, wherein at least a portion of the fabric frame portion has an elastomer in the fabric pores and the sewing cuff portion of the fabric does not have an elastomer present in the fabric pores; and
coupling a composite material to at least a portion of the fabric frame portion with the fabric frame portion disposed between the frame and the composite material and such that the sewing cuff extends from the frame.
2. The method of claim 1 , further comprising:
wrapping a first layer of film into a tubular form about a mandrel;
placing the fabric partially over the first layer of film;
placing the frame over the fabric that is over the first layer of film;
everting the fabric over the frame to define a fold in the fabric with the fold, the fold defining the sewing cuff at a base of the frame;
wrapping a second layer of film over the frame; and
coupling the first layer of film and the second layer of film to each other, to the fabric, and to the frame.
3. The method of claim 2 , further comprising providing filler material in the fold of the fabric, wherein after everting the fabric the filler material is contained within the fold.
4. The method of claim 2 , further comprising coupling one or more leaflets to the frame.
5. The method of claim 2 , the frame further comprising two or more frame strut elements extending from the base to define a plurality of leaflet windows.
6. The method of claim 5 , wherein one or more of the first layer of film and the second layer of film extends into each of the leaflet windows to define leaflets therein.
7. The method of claim 2 , wherein the frame has a frame inside surface and a frame outside surface opposite the frame inside surface, the fabric frame portion being coupled to the frame inside surface, the fabric frame portion disposed between the frame inside surface and the composite material.
8. The method of claim 2 , wherein the frame has a frame inside surface and a frame outside surface opposite the frame inside surface, the fabric frame portion being coupled to the frame inside surface and the frame outside surface, the fabric frame portion disposed between the frame inside surface and the composite material, and the fabric frame portion disposed between the frame outside surface and the composite material.