A new stent graft. With thin walled controlled micropored polymer covering.

SUMMARY: The use of stents improves the result after balloon coronary angioplasty. Restenosis due to neointimal hyperplasia and proliferation of smooth muscle cells are, however, a concern. In the present report, we studied the prevention of restenosis to allow endothelial cell migration and growth to proceed through micropores using our developed stent graft with micropored segmented polyurethane (SPU) thin film in a normal beagle model. Our developed stent graft was made from Palmaz stent and micropored SPU thin film. The SPU film was arranged into four different micropore densities around the circumference: no micropores, arrangement 4; micropores of 30mum in diameter with an orderly distance of 250mum; (arrangement 1), 500mum; (arrangement 2) and 125mum (arrangement 3) between the neighboring two pores. Micropores were made using the Excimer laser ablation technique. The Palmaz stent was wrapped with micropored film, sutured, and glued with DMF (dimethyl formamide) under aid of a microscope. These stents were placed in the common carotid arteries of beagles (n = 5). They were sacrificed at 1 month, and a histological study and scanning electron microscopy study were performed for evaluation of endoluminal endothelialization. In 10 arteries applied with stent grafts, there was no severe stenosis although it did occur to some extent. All stented arteries were patent. Endothelial cell migration and growth through micropores were observed histologically on micropored SPU thin film in this model, which did not affect the intraluminal diameter. In most non-porous regions, significant thrombi were found between the SPU film and the neointimal layer. On the other hand, in the porous region, little thrombosis was observed except in the lowest density region. In 125mum of distance between two neighboring pores, the neointimal layer was the thinnest, which was suitable for wide intraluminal space after placement of a stent graft. Endothelial cell migration and growth through micropores were confirmed in the animal model using our developed micropored stent graft. The proceeding of their migration was controlled by micropore density under a constant micropore diameter. The stent graft with micropored SPU thin film is promising for the prevention of restenosis due to neointimal hyperplasia.