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.
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.
|Chen, Zhan; Ward, Robert; Tian, Yuan et al. (2002) Interaction of fibrinogen with surfaces of end-group-modified polyurethanes: a surface-specific sum-frequency-generation vibrational spectroscopy study. J Biomed Mater Res 62:254-64|