SBIR Phase I: A Novel Antimicrobial Polymer for Medical Devices

SBIR 第一阶段：用于医疗器械的新型抗菌聚合物

• 批准号: 0944025
• 负责人: Michael Szycher
• 金额: --
• 依托单位: STERLING BIOMEDICAL, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-01 至 2010-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=0944025&HistoricalAwards=false
• 关键词: SBIR; Phase; Novel; Antimicrobial; Polymer

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.

这个小企业创新研究第一阶段项目解决了与基于聚合物的植入式医疗设备相关的昂贵和致命感染问题。当细菌附着在聚合物表面，形成一层生物膜时，设备感染就会发生，这种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败血症病例的90%左右。因此，迫切需要一种长效的抗菌聚合物。这项技术通过将银基抗菌剂掺入聚氨酯中，抑制医疗设备上的细菌粘附和生物膜的形成，减少了灾难性生物材料感染的机会。本研究的研究目标是对我们的配方进行初步测量，以确定我们的新型生物材料的机械，化学和长期抗菌性能，以确定其功效。总体目标是证明这种新概念在体内的可行性。该项目更广泛的影响/商业潜力包括提高对抗菌植入式装置的技术理解。该项目还将通过降低与植入物引起的感染有关的患者发病率和死亡率来影响社会。最后，本研究将产生显著的商业影响；每年有超过10万例与设备相关的感染，医疗保健成本每年超过40亿美元。医疗保险和医疗补助服务中心已将这些感染作为2008年10月开始根除的重点。2009年，它将停止支付医院设备感染的费用。医院每年购买数以百万计的植入装置。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。所提议的技术可以大规模生产，并可能导致成功的商业化和生产具有成本效益的医疗设备。慢性静脉导管的全球市场估计每年为6亿美元，这对该公司来说是一个重要的市场机会，并且由于导管相关感染而大大降低了国家护理成本。