In vitro evaluation of blood plasma coagulation responses to four medical-grade polyurethane polymers

Segmented polyurethane (PU) block copolymers are widely used in implantable cardiovascular medical devices due to their good biocompatibility and excellent mechanical properties. More specifically, PU Biospan MS/0.4 was used in ventricular assist devices over the past decades. However, this product is being discontinued and it has become necessary to find an alternative PU biomaterial for application in cardiovascular devices. One important criterion for assessing cardiac biomaterials is blood compatibility. In this study, we characterized the surface properties of four medical-grade PU biomaterials: Biospan MS/0.4, BioSpan S, BioSpan 2F, and CarboSil 20 80A, including surface chemistry, topography, microphase separation structure and wettability, and then measured the blood plasma coagulation responses using bovine and human blood plasma. Results showed that BioSpan 2F contains high amounts of fluorine and has the lowest surface free energy while the other materials have surfaces with silicone present. An in vitro coagulation assay shows that these materials demonstrated improved blood coagulation responses compared to the polystyrene control and there were no significant differences in coagulation time among all PU biomaterials. The chromogenic assay showed all PU materials led to low FXII contact activation, and there were no significant differences in FXII contact activation, consistent with plasma coagulation responses.