Abstract: Single and dual frame prosthetic venous valve assemblies, and catheter delivery systems and methods, are disclosed. A representative dual frame venous valve assembly includes an outer valve frame having a lumen and a frame and venous valve assembly arranged within the lumen. The frame and venous valve assembly, which also may be a stand-alone prosthetic venous valve assembly, includes an inner valve frame having a frame matrix forming lateral valve supports and valve commissure supports; a polymeric frame coating encapsulating the frame matrix; and a one or more polymeric leaflets integrally formed with or coupled to the polymeric frame coating, with each leaflet moveable between an open or partially open state and a closed or partially closed state. A delivery catheter includes keys or slots for insertion of locking tabs of the outer valve frame, and a deployment control handle for controlling deployment of the venous valve assembly.

Abstract: A method of forming a double-walled unit from thermoplastic materials, preferably polymethyl methacrylate, in which two sheets, one of which is provided with an aperture to allow the passage of air between the sheets, are stretched apart under thermoforming conditions by imposed pressure differences, the desired spatial relationship between the sheets being obtained by adjustment of the pressure differences, and in which the sheets are simultaneously bonded about their perimeters.