ANTIMICROBIAL COATING FOR IMPLANTABLE DEVICES

该项目的主要目标是为医疗器械开发抗菌治疗方法，通过消除器械相关感染的发生来提高其长期疗效。医疗器械感染仍然是许多植入物的严重并发症，导致高危人群的发病率和死亡率很高。这些抗菌涂层的应用非常广泛，包括完全植入式的设备（例如心血管设备、浆膜贴片）和穿透皮肤的设备（例如导管）。提出的处理技术采用固态化学，在导管表面周围主动创建气相生物杀灭微环境。在植入之前，反应化学以专有的二氧化氯生成前体配方的形式保持稳定。在与经皮组织中的水分接触后，化学物质会产生反应，形成抗菌微环境。这一阶段的建议侧重于使用一种新的固体化学处理生物医学植入物，这将有效对抗广泛的微生物污染。经皮导管的建立模型将用于评估这种抗菌治疗对后续脑室感染的有效性。这些研究的结果也将广泛适用于需要经皮放置的设备，包括用于心血管设备和血管通路设备的驱动线。拟议的商业应用：目前在美国，医院每年使用超过500万个导管，主要是在重病患者的大手术后使用。据估计，在美国医院里90%的血液感染都是由导尿管引起的，每年有超过20万例。过去的研究表明，10%到25%的感染者死亡。虽然经过治疗的导尿管比未经治疗的要贵，但从长远来看，节省的费用是巨大的。导尿管引起的血液感染可以让病人在重症监护室呆近7天，花费近29,000.00美元。

The primary goal of this project is to develop antibacterial treatments for medical devices that improve their long-term efficacy by eliminating the occurrence of device related infections. Medical device infections remain a serious complication of numerous implants resulting in significant morbidity and mortality in the at risk population. The applications for these antimicrobial coatings are extensive and include devices that are totally implantable (e.g. cardiovascular devices, serosal patches) and devices which penetrate the skin (e.g. catheters). The treatment technology proposed employs a solid state chemistry that actively creates a gas phase biocidal microenvironment around a catheter surface. Prior to implantation, the reactive chemistry remains stable in the form of a proprietary chlorine dioxide generating precursor formulation. Upon contact with the moisture in transcutaneous tissue the chemistries become reactive forming the antimicrobial microenvironment. This phase I proposal focuses on the use of a novel solid state chemistry treatment for biomedical implants which will be effective against a broad spectrum of microbial contamination. An established model of a transcutaneous catheter will be used to evaluate the effectiveness of this antimicrobial treatment on subsequent intraventricular infections. The results of these studies will also be applicable to a wide range of devices requiring transcutaneous placement including drive lines used in cardiovascular devices and vascular access devices. PROPOSED COMMERCIAL APPLICATIONS: Currently in the United States over 5 million catheters are used annually by hospitals, primarily after major operations on seriously ill patients. It is estimated that catheters are blamed for 90 % of bloodstream infections contracted in U.S. hospitals, or more than 200,000 cases a year. Past studies have shown that 10 % to 25 % of the infected patients die. Although treated catheters cost more than untreated ones, long-run savings could be enormous. A blood infection caused by a catheter can keep a patient in intensive care for nearly 7 days, costing nearly $29,000.00.