A novel process for the manufacturing of porous grafts: process description and product evaluation.

A novel process has been developed for the manufacture of porous vascular grafts from solutions or melts of polymers. It allows the manufacture of grafts with controllable porosity, pore size, and mechanical properties. In this process, the polymer melt or polymer solution is extruded through fine orifices; the fibers are then stretched and wound on a rotating mandril. Fiber-fiber bonding takes place, resulting in the formation of stable porous tubes. The effects of the process variables on the physical properties of the resulting graft have been studied and preliminary in vivo evaluation in dogs has demonstrated graft patency with a thin, stable neointima in both small (4 mm) and large (10 mm) caliber configurations.