Design Considerations for a Small Bore Vascular Prosthesis

Abstract

No synthetic prosthesis has yet been found which can satisfactorily be used as a substitute for saphenous veins in vascular surgery. One explanation for the lack of success is that their properties and behaviour do not mimic those of the arteries they replace. The essential features for a successful vascular prosthesis, over and above biocompatibility, are a low friction non-thrombogenic flow surface, mechanical (elastic) behaviour that matches natural artery and dimensions that approximate the host vessels. This will allow a high velocity of flow with low impedance. A prosthesis with this specification would avoid the problems of flow disturbances and reflection at the anastomoses, pulse wave damping and large pressure gradients, all of which reduce pulsatile energy.

We have designed a vascular prosthesis based upon the above criteria. It has an internal diameter of 4 mm and a wall thickness of 1 mm. Its geometry makes it kink resistant and a good match for tibial and coronary arteries. The prosthesis is made from Polyurethane and its mechanical properties, which approximate to those of peripheral arteries, are achieved via a mechanism of internal wall compression rather than external circumferential expansion.

To assess the in-vivo potential of this prosthesis, 21 grafts were implanted in 11 sheep, replacing a section of carotid artery with a 6 cm long prosthesis. All 21 grafts were patent after 3 months. One graft was removed for histological examination. 16 of the remaining 20 grafts were patent after 7 months. Problems associated with thrombosis were not encountered and we conclude that this prosthesis shows good potential as a small bore vascular substitute.