SBIR Phase I: A Novel Antimicrobial Polymer for Medical Devices

这个小型企业创新研究第一阶段项目解决了与聚合物为基础的植入式医疗设备相关的昂贵和致命的感染问题。当细菌附着在聚合物表面时，就会发生设备感染，形成的生物膜对抗生素的敏感性比浮游细菌低100到1000倍。虽然估计只有5%的静脉导管被感染，但这相当于重症监护医学中所有脓毒症病例的90%左右。因此，迫切需要一种长期的抗菌聚合物。这项技术通过在聚氨酯中加入银基抗菌剂来减少灾难性的生物材料感染的机会，从而抑制医疗器械上的细菌黏附和生物膜的形成。本研究的研究目标是对我们的配方进行初步测量，以确定它们的机械、化学和我们新型生物材料的长期抗菌性能，以确定它们的有效性。总体目标是在体内证明这一新概念的可行性。该项目的更广泛的影响/商业潜力包括加强对抗菌植入性设备的技术理解。该项目还将通过降低与植入物引起的感染相关的患者发病率和死亡率来影响社会。最后，这项研究将产生重大的商业影响；每年有超过100,000例与设备相关的感染，每年的医疗成本超过40亿美元。这些感染已被医疗保险和医疗补助服务中心列为从2008年10月开始根除的优先事项。2009年，它将停止支付医院设备感染的费用。医院每年购买数百万台可植入设备。数十亿美元的植入式设备市场需要制造抗感染设备的新技术。这项拟议的技术可以大规模生产，并可能导致低成本医疗器械的成功商业化和生产。慢性静脉导管的全球市场估计每年价值6亿美元，这对该公司来说是一个重要的市场机会，并因导管相关感染而大幅降低了国家护理成本。

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.