Three medical-grade polyurethane families have attained commercial significance: (1) an aromatic polyurethaneurea (BIOMER, MITRATHANE); (2) aliphatic polyetherurethanes (TECOFLEX, TEXIN DP7); (3) aromatic, polyetherurethanes (PELLETHANE 2363, TEXIN 900). These polymers are essential in the fabrication of artificial heart diaphragms, vascular grafts, pacemaker lead insulators, implantable ports, and other chronic implantable devices. Because of legal liability concerns, several manufacturers have withdrawn medical-grade polyurethanes from the implantables market. In addition, the exact composition of these polymers is largely unknown. While some patents have expired, the true chemical composition and compounding ingredients (and thus, extractibles) remain unknown, making it difficult to accurately and reproducibly test the biological properties of these materials. They propose to synthesize large quantities (1000 lbs of each polymer hardness) of well characterized polymers. The synthesis and pelletization will be performed at CardioTech and most of the characterization tests will be performed at the University of Akron.
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