Development of blood-compatible elastomers. V. Surface structure and blood compatibility of avcothane elastomers.

The Avcothane 51 elastomer, a member of a series of proprietary materials best characterized as polyurethane/poly(dialkylsiloxane) block copolymers, displays considerable hemocompatibility without any incorporated anticoagulants. In the form of intra-aortic balloons, the elastomer was implanted in several thousands of cardiac patients without intolerable hematologic effects. Hemocompatibility has been assumed to result from a predominantly dispersion-type surface force field whose intensity fluctuates within small domains, maintaning adsorbed blood proteins in an unstable state. The relative hemocompatibility of films, which were obtained from a prepolymer solution cast on substrates impenetrable to the solvent, is a function of the effective surface molecular structure. This can vary as a function of preparative conditions (temperature and rate of evaporation), and has been correlated with an anisotropic distribution of the silicone component in cured films. The concentration of this component in surface layers was quantified independently by IRATR spectroscopy and electron-microprobe analysis, giving consistent results. An IRATR index, which is computed from the ratio of absorptivities measured at 13.00 and 12.62 mu and is inversely proportional to the relative silicone content of surface layers, was found to correlate with the apparent hemocompatibility determined by different in vitro methods. Optimized reproducible hemocompatibility is attained by strict process controls.