Development of a prosthetic venous valve.

The pathology of thrombophlebitis primarily results from the obliteration of venous valves in the lower extremities. The objective of this study was to develop a prosthetic venous valve that could be implanted in the human femoral system to ameliorate the deleterious effects of thrombophlebitis. Prosthetic venous valves were produced from two materials: Pellethane valves were fabricated from a dip-casting process; umbilical vein valves were produced by a fixation process. The valves were evaluated as implants within the external jugular veins of 10 research dogs. Each animal was implanted with one Pellethane valve in one external jugular vein and one umbilical vein venous valve in the contralateral jugular vein. Each valve was positioned over a stainless-steel cylinder that had been implanted into the jugular veins in such a manner that there existed no blood-cylinder interaction. Patency of the valves was determined by X-ray venography at 24, 48, and 72 h and at 5 and 8 days postoperatively. All of the umbilical vein venous valves were occluded by the end of 48 h, whereas two of the Pellethane venous valves remained patent for at least 5 days but were occluded at 8 days. The results of this study suggest the possibility of success of Pellethane valve implants in the venous circulation and indicate future directions for study.