POLYURETHANEUREA PRIMARY REFERENCE MATERIALS

聚氨酯被用于各种生物医疗设备，包括 人造心脏、起搏器导线、主动脉内气囊和导管。 大多数商业上可获得的聚氨酯是基础聚合物和 一种或多种添加剂，包括催化剂、抗氧化剂、光 稳定剂、颗粒填充剂和表面活性加工助剂(例如 润滑剂和表面改性剂)。这些添加剂的存在，这些添加剂 通常是制造商的专有，这严重地使 聚氨酯作为生物材料的研究。这项建议涉及 四种聚氨酯脲(PUU)的合成、制备与表征 主要标准物质(PRM)。三个PRM将是无添加剂的PUU， 除了软段的化学成分外，几乎完全相同。高纯度PUU 来自聚环氧乙烷、聚四亚甲基醚(PTMO)和 聚二甲基硅氧烷将在溶液中合成。PTMO PUU的一半 溶液将用于通过以下方式制备第四种PRM(Bimer(R)的类似物) 添加抗氧剂和含受阻胺的甲基丙烯酸酯 共聚物。不含多余表面活性的聚合物溶液 由ESCA和静态SIMS确定的污染物将被制造出来 制成薄膜和管子样品，并将被包装、消毒和 在几个实验室中得到了彻底的表征。刻画的PRM 将提供操作说明，作为实验室间的标准 生物材料研究人员和医疗器械制造商。 建议的商业应用：聚氨基甲酸酯尿素主要参考 材料将商业化，作为校准的标准 理化和生物测试。PRM的制造提供了一种 特性良好、稳定的聚氨基甲酸乙酯标准物质来源， 不同程度的疏水性/亲水性，对调查人员来说 对研究散体性质对血液材料的影响感兴趣 互动。

Polyurethanes are used in a variety of biomedical devices including artificial hearts, pacemaker leads, intra-aortic balloons and catheters. Most commercially-available polyurethanes are blends of a base polymer and one or more additives, including catalysts, antioxidants, light stabilizers, particulate fillers and surface-active processing aids (e.g. lubricants and surface modifiers). The presence of these additives, which are usually proprietary to the manufacturer, seriously complicates the study of polyurethanes as biomaterials. This proposal involves the synthesis, fabrication and characterization of four polyurethaneurea (PUU) Primary Reference Materials (PRM). Three PRMs will be additive-free PUUs, virtually identical except for soft segment chemistry. High-purity PUUs from polyethyleneoxide, polytetramethyleneoxide (PTMO) and polydimethylsiloxane will be synthesized in solution. Half the PTMO PUU solution will be used to prepare a fourth PRM (an analog of Biomer(R)) by adding an antioxidant and a hindered-amine-containing methacrylate copolymer. Polymer solutions that are free of unwanted surface-active contaminants, as determined by ESCA and static SIMS, will be fabricated into film and tubing samples, and will be packaged, sterilized and thoroughly characterized in several laboratories. The characterized PRM will be offered with handling instructions, as inter-laboratory standards to biomaterials researchers and manufacturers of medical devices. PROPOSED COMMERCIAL APPLICATION: The Polyurethaneurea Primary Reference Materials will be commercialized as standards for calibration of physicochemical and biological tests. The fabrication of PRM provides a source of well characterized, stable polyurethaneurea reference materials, with different levels of hydrophobicity/hydrophilicity, to investigators interested in studying the effect of bulk properties on blood-materials interactions.