SBIR Phase I: A Novel Antimicrobial Polymer for Medical Devices

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This Small Business Innovation Research Phase I project addresses the issue of costly and fatal infections associated with polymer-based, implantable medical devices. Device infections occur when bacteria adhere to the polymer surface, forming a biofilm that can be 100 to 1,000 times less susceptible to antibiotics than are planktonic bacteria. While only an estimated 5% of venous catheters become infected, this equates to about 90% of all sepsis cases in intensive care medicine. Thus, there is a critical need for a long-term, antimicrobial polymer. This technology reduces the chances for catastrophic, biomaterial infections by incorporating silver-based antimicrobial agents into polyurethane which inhibits bacterial adhesion and biofilm formation on medical devices. The research objectives of this study are to make initial measurements on our formulas to determine their mechanical, chemical, and long-term antimicrobial properties of our novel biomaterial to determine their efficacy. The overall goal is to demonstrate in vivo feasibility of this new concept.The broader impact/commercial potential of this project includes enhancing technological understanding of antimicrobial implantable devices. The project will also impact society by decreasing patient morbidity and mortality related to implant -caused infections. Finally, this research will have significant commercial impact; with over 100,000 device-related infections each year, the healthcare cost is over $4.0 billion annually. These infections have been targeted by the Center for Medicare and Medicaid Services as priorities for eradication starting October 2008. In 2009 it will stop paying for hospital-based device infections. Hospitals purchase millions of implantable devices yearly. The multi-billion dollar implantable device market needs new technology for manufacturing infection-resistant devices. The proposed technology can be manufactured on a large-scale, and could lead to the successful commercialization and production of cost-effective medical devices. The worldwide market for chronic venous catheters is estimated at $600 million annually, representing a significant market opportunity for the company and a major reduction in national care costs due to catheter-related infections.