POLYMER MODIFICATION VIA SURFACE-MODIFYING END GROUPS

本研究的目的是开发一种使用“表面改性端基”（SME）的表面改性热塑性塑料的制造方法。迄今为止，SME方法主要用于溶液加工的嵌段聚氨酯，在体外和体内试验中提供增强的抗血栓性、生物稳定性和耐磨性。 在第一阶段，我们使用了一系列的表面敏感的分析耐磨性在体外和体内测试。在第一阶段，我们使用了一系列表面敏感的分析工具，如和频发生（SFG），原子力显微镜（AFM），电子光谱化学分析（ESCA）和接触角测角法，以充分表征我们的聚合物。我们的研究表明，SME技术可以有效地将一小部分端基共价引入到聚合物体系中，并显着改变SME聚合物表面的表面化学。端基富集的区域调节植入聚合物的生物功能性和生物相容性。由于端基会显著改变聚合物的表面性质，因此聚合物的本体性质几乎不受影响。为了将SME技术应用于制造最广泛的医疗产品，大量需要可挤出和可模制（即热塑性）SME聚合物。我们目前正在安装一个生产规模的连续反应器冷却造粒机的传统聚氨酯生产。本研究将支持开发、表征、生物相容性试验和验证各种表面改性聚氨酯生物材料的生产工艺。在第三阶段，SME将向（长期植入）器械和假体的制造商提供几种类型的热塑性塑料销售。拟定的商业应用：这些新型聚合物预期用于医疗器械的生产。它们满足了对在短期和长期植入中具有改善的稳定性和生物相容性的材料的需求。未配置的生物医学聚合物和此类组件的市场每年超过1亿美元。使用这些聚合物的装置的销售每年可超过10亿美元。

The object of this study is to develop a manufacturing method for surface- modified thermoplastics using "surface modifying end groups" (SME). To date, the SME method has been used primarily with solution- processed segmented polyurethanes giving enhanced thromoboresistance, biostability and abrasion resistance in vitro and in vivo tests. In Phase I we used a series of surface sensitive analytical abrasion resistance in vitro and in vivo tests. In Phase I we used a series of surface sensitive analytical tools such as Sum Frequency Generation (SFG), Atomic Force Microscopy (AFM), Electron Spectroscopy for Chemical Analysis (ESCA) and Contact Angle Goniometry to fully characterize our polymers. Our studies have shown that SME technology could efficiently introduce a small fraction of end-groups covalently into polymer systems and dramatically change the surface chemistry of SME polymer surfaces. The region which end groups enrich in modulates biofunctionality and biocompatibility of implanted polymers. As the surface properties are changed dramatically by the end groups, bulk properties of polymers are virtually unaffected. To apply SME technology to do the broadest range of medical products, extrudable and moldable (i.e. thermoplastic) SME polymers are need in quantity. We are currently installing a production- scale continuous reactor-chiller pelletizer for conventional polyurethane manufacture. This study would support development, characterization, biocompatibility testing and validation of a process for the manufacture of a wide range of surface-modified polyurethane biomaterials. In Phase III SME theremoplastics of several types will be offered for sale to manufacturers of (chronically-implanted) devices and prostheses. PROPOSED COMMERCIAL APPLICATIONS: These novel polymer are intended for use in the manufacture of medical devices. They fill a need for materials having improved stability and biocompatibility in short and long term implantations. The market for unconfigured biomedical polymers and components of this type exceeds $100 million annually. The sale of devices with using these polymers could exceed $1 billion annually.