ABSTRACT

This chapter details the events that are involved in the biological response to a polyurethane including protein adsorption, blood and soft tissue interactions and immunologic complications. Ex vivo studies are relevant to the study of blood-biomaterial interactions. The main purpose of in vivo tests is to evaluate the safety and biocompatibility of a device. Clinical evaluation is the most relevant assessment of the biocompatibility of a material in a given application. Development of medical devices requires that materials and devices are tested prior to clinical use, in order to evaluate the safety of the implant. The investigation of protein adsorption to artificial surfaces has been significant in biocompatibility research. Keogh and Eaton have shown that Pellethane modified with a dextran-cibacron-blue adduct selectively and reversibly binds albumin. The adsorption of fibrinogen onto biomaterial surfaces is of interest, owing to the protein's role in mediating cellular responses, and as a coagulation protein.