Continuous Biofilm Disrupting Materials

描述（由申请人提供）：根据Frost & Sullivan的研究，保险公司抵抗医院获得性感染率的压力越来越大，预计将在抗感染治疗和材料的增长中发挥关键作用。耐多药细菌生物膜对医疗设备构成持续威胁，最近健康保险公司表现出不承保医院相关感染事件的强烈趋势。诸如在导管或设备上涂覆抗生素或防腐剂（如纳米银、磺胺嘧啶银和/或氯己定）、抗生素等技术已经商业化，但由于快速释放导致洗脱抗菌剂耗竭，成功程度有限。大多数医疗设备，如血管导管和其他导管以及非血管支架，都是由热塑性医用级聚合物（如聚氨酯）制成的。添加剂，如颜色，惰性填料等，在熔融条件下与树脂混合，成球，然后用于挤出。我们提出了在实验室规模上结合热稳定，抗菌，生物膜抑制配方的想法，将其复合到医用级聚氨酯中，然后挤压。我们将开发能够以有效水平持续释放活性物质长达30天的组合物。这种材料可以进一步优化，在几个月内表现出超慢的释放。（最终目标是6个月）在第一阶段，为了证明我们的概念，我们将合成和开发具有抗菌抑制剂功能的配方，并形成独特的银种，这些银种在生物介质中更易于溶解和稳定。在第一阶段的研究中，这些添加剂将被用作不同级别的添加剂，加入到使用不溶于水的纳米级天然载体的医用级聚氨酯基质中，并作为平面塑料样品进行复合和加工。我们希望证明从这种基质中高度控制的长期释放，在具有血清的生物培养基中为表面提供抵抗临床病原体的生物膜。我们将创建具有精确活性物质浓度的材料，并筛选它们的洗脱谱，细菌附着动力学和生物膜废除。Frost & Sullivan最近的分析发现，2005年美国抗菌药物市场的收入为1.754亿美元，预计到2012年将达到5.587亿美元。随着医疗保健设施等终端应用市场对微生物生长的需求日益增加，该市场预计将增长。

DESCRIPTION (provided by applicant): An increasing pressure to resist the hospital-acquired infection rates by insurance providers is expected to play a crucial role in the growth of the infection resistant treatments and materials according to Frost & Sullivan research. Muti-drug resistant bacterial biofilms pose a constant threat to medical devices and recently the health insurance companies are showing a strong trend of non-coverage of hospital related infection episodes. Technologies such as coating of the catheters or devices with antibiotics or antiseptics like as nano silver, silver sulfadiazine and/or chlorhexidine, antibiotics have been commercialized with limited success due to rapid release rates resulting in depletion of the eluting antimicrobials. Most medical devices such as vascular and other catheters and non-vascular stents are made of thermoplastic medical grade polymers such as polyurethanes. Additives such as colors, inert fillers etc are compounded with a resin under melt conditions, pelletized and then used for extrusion. We propose the idea of incorporating on lab scale, a thermally stable, antimicrobial, biofilm inhibiting formula by compounding it into a medical grade polyurethane followed by extrusion. We will develop compositions with an ability to release active material for up to 30days in sustained manner at effective levels. Such materials could be further optimized to show ultra slow release over several months. (6months is the ultimate target) During the Phase I, for the proof of our concept, we will synthesize and develop formulations that function as antimicrobial inhibitors and form unique silver species that are more soluble and stable in biological media. These will be used as additives at various defined levels into to a medical grade polyurethane matrix using a water insoluble nanosize natural carrier, compounded and processed as flat plastic samples for the Phase I study. We hope to demonstrate a highly controlled long term release from such matrices that provide the surface with biofilm resistance against clinical pathogens in a biological medium with sera. We will create materials with precise concentrations of the active materials and screen them for elution profile, bacterial attachment kinetics and biofilm abrogation. PUBLIC HEALTH RELEVANCE Recent analysis from Frost & Sullivan found that the U.S. antimicrobial treatment markets earned revenues of $175.4M in 2005 with estimates to reach $558.7M by 2012. The market expects to grow with the increasing need to address microbial growth in end-application markets like health care facilities.