Antimicrobial Coatings to Reduce Hospital Infections

 描述(申请人提供)：为了对抗医疗保健相关感染(HAI)，目前HAI已成为美国第三大死亡原因，TDA Research，Inc.提议为高接触不锈钢表面开发新的抗菌铜合金涂层，可能占所有HAI的40%。低成本、耐用的涂料将被科学地设计用于催化产生羟基自由基*OH，它在水中任何非氟化物种中具有最高的氧化还原电位(2.76V)，超过所有常见消毒剂：臭氧-2.076V，过氧化氢-1.776V，次氯酸-1.482V和二氧化氯-0.954V。羟基自由基的极端氧化能力可以破坏细菌和真菌细胞壁以及孢子和病毒涂层。铜提供了各种其他的杀灭机制，包括与包括过氧化氢酶在内的微生物防御酶结合。在潮湿的环境中，Cu1+和Cu2+离子扩散并置换细胞膜离子通道中的Na1+和K1+，破坏它们的半透性，导致微生物破裂。临床试验毫不含糊地证明，在重症监护病房中，大约40%的医疗保健获得性感染是通过只更换病房中最常接触的几个物体来消除的：床边栏杆、护士呼叫按钮、访客椅扶手、床上转台和静脉输液柱。此外，临床数据显示，铜在现实世界的医院环境中保持着抗菌活性，并且不会通过正常的处理而失活。尽管事实证明非常有效，但将所有医院高接触物品更换为固体固定装置 铜的成本高得令人望而却步。此外，纯铜腐蚀速度很快，而且太软，无法抵抗磨损。为了解决这些问题，TDA Research，Inc.建议开发具有成本效益的方法，专门在现有的不锈钢表面沉积铜合金薄膜(~4微米厚)，这些表面包括医院普遍使用的大约一半的高接触表面，但几乎没有抗菌性能。铜合金将被开发为附着力、耐腐蚀性和耐磨性、易于应用，并将被掺杂以最大限度地催化产生羟基自由基。在第一阶段，将明确遵循《联邦杀虫剂、杀菌剂和灭鼠剂法案》规定的抗微生物铜注册所需的标准议定书。这涉及对五种病原体进行1“x 1”优惠券测试：金黄色葡萄球菌(美国典型培养库，atc6538)、耐甲氧西林金黄色葡萄球菌菌株(Atcc 33592)、致病性大肠杆菌O157：H7(Atcc 35150)、产气性肠杆菌(Atcc 13048)和假单胞菌(Atcc 15442)。作为对照，将测试未涂覆的不锈钢、纯铜和涂有纯铜的不锈钢。第一阶段的研究将被认为是成功的，如果微生物负荷与标准方案要求的未涂层样品相比减少了至少3log10；同时满足ASTM Elcometer 107划痕测试和5000次泰伯浮石/CL1腐蚀/磨损测试(ASTM D-4060)，以承受相当于150,000次手触摸，同时降低成本。

 DESCRIPTION (provided by applicant): To combat Healthcare Associated Infection (HAI), which is now the 3rd leading cause of death in the U.S., TDA Research, Inc. proposes to develop new antimicrobial copper-alloy coatings for high-touch stainless-steel surfaces that may be responsible for 40% of all HAI. Low-cost, durable coatings will be scientifically designed for the catalytic production of hydroxyl radicals, *OH, which have the highest oxidation-reduction potential (2.76V) of any non-fluorinated species in water, surpassing that of all common disinfectants: ozone-2.076V, hydrogen peroxide-1.776V, hypochlorous acid-1.482V and chlorine dioxide-0.954V. The extreme oxidizing potential of hydroxyl radicals allows destruction of bacterial and fungal cell walls as well as spore and virus coatings. Copper provides a variety of other kill-mechanisms, including binding to microbial defensive enzymes including catalase. In moist environments, Cu1+ and Cu2+ ions diffuse and displace Na1+ and K1+ in cell- membrane ion channels, destroying their semi-permeable properties and causing microorganisms to rupture. Clinical trials unambiguously demonstrate that ~40% of Healthcare Acquired Infection in intensive-care units is eliminated by replacing only a few of the most frequently touched objects in patient rooms: bed side-rails, nurse call buttons, visitor-chair arm rests, over-bed tra tables and IV posts with pure copper. Further, the clinical data shows that copper retains antimicrobial activity in real-world hospital settings and is not deactivated by normal handling. Although proven extremely effective, replacing all hospital high-touch items with fixtures of solid copper is cost-prohibitive. Moreover, pure copper quickly corrodes and is too soft to resist abrasion. To address these issues, TDA Research, Inc. proposes to develop cost-effective methods to deposit thin films (~4µm thick) of copper alloys specifically onto existing stainless-steel surfaces that comprise roughly half of the high-touch surfaces prevalent in hospitals, but which possess little or no antimicrobial properties. The copper alloys will be developed for adhesion, resistance against corrosion and abrasion, ease of application, and will be doped to maximize the catalytic production of hydroxyl radicals. In Phase I, standard protocols required for the registration of anti-microbial copper under the Federal Insecticide, Fungicide and Rodenticide Act, will be followed explicitly. This involves testing of 1" x 1" coupons against the five pathogens: Staphylococcus aureus (American Type Culture Collection, ATCC 6538), a methicillin-resistant strain of S. aureus (ATCC 33592), pathogenic Escherichia coli O157:H7 (ATCC 35150), Enterobacter aerogenes (ATCC 13048) and Pseudomonas aeuginosa (ATCC 15442). As controls, uncoated stainless-steel, pure copper, and stainless-steel coated with pure copper will be tested. Phase I research will be considered a success if the microbial burden is reduced a minimum of 3log10 relative to uncoated samples as required by the standard protocol; simultaneously meeting ASTM Elcometer 107 scratch tests and a 5000-cycle Taber pumice/Cl1- corrosion/wear test (ASTM D-4060) to withstand an equivalent of 150,000 hand touches, while reducing costs.