In vitro biostability testing of stent cover materials

Abstract Cast polyurethane films made of an aliphatic polycarbonate-based thermoplastic polyurethane (Carbothane PC) and poly(ether urethane) (Pellethane) were manufactured and their biostability under a static strain rate was investigated in vitro in comparison to unloaded samples. The PU films were stretched to an elongation of 300% and exposed to hydrogen peroxide/cobalt chloride (H2O2/CoCl2) solution for specific periods of time (up to 63 days). Unstrained PU samples were treated in the same way for comparison. The samples were observed for surface degradation via scanning electron microscopy and the bulk erosion by measuring the weight difference. The surface roughness greatly increased in strained Pellethane with scanning electron microscopy (SEM) evidence of deep cracks and holes or ragged and stretched fractures perpendicular to the direction of stress. Carbothane showed a lower degradation compared with Pellethane under mechanical constraint.