Nanosilver-based Technologies for Infection Prevention in Respiratory and Related

用于预防呼吸道及相关感染的纳米银技术

• 批准号: 7538158
• 负责人: Lacramioara Darie Schulte auf'm Erley
• 金额: $ 18.86万
• 依托单位: NANODYNAMICS LIFE SCIENCES, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-01 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7538158
• 关键词: Address; Adverse reactions; Affect; Agreement; American; Anti-Bacterial Agents; Area; Bacteria; Benchmarking; Biocompatible; Biological; Biological Assay; Breathing; Caustics; Centers for Disease Control and Prevention (U.S.); Cessation of life; Chemicals; Chemistry; Cidex; Communities; Condition; Data; Development; Devices; Disease; Disinfection; Effectiveness; Elastomers; Environment; Escherichia coli; Genus Mycobacterium; Goals; Growth; Home environment; Hospitals; Humidifier; Hytrel; Image; Immune system; Infection; Infection prevention; Injection of therapeutic agent; Joints; Laboratories; Liquid substance; Long-Term Care; Manufacturer Name; Masks; Mechanical Ventilators; Mechanics; Medical; Medical Device; Molds; Nosocomial Infections; Nursing Homes; Patients; Phase; Phase II Clinical Trials; Plastics; Polymers; Preparation; Process; Property; Public Health; Purpose; Range; Reducing Agents; Research; Running; Scanning Transmission Electron Microscopy Procedures; Silicon; Silicone Elastomers; Silicones; Silver; Source; Speed; Standards of Weights and Measures; Sterilization for infection control; Structure; Surface; Technology; Temperature; Testing; Translating; Tube; United States Food and Drug Administration; Ventilator; Virus; Work; antimicrobial; antimicrobial drug; base; biomaterial compatibility; cost; cost effective; desire; ethyl vinyl acetate; exhaust; interest; nanomaterials; particle; physical property; polycarbonate; prevent; research and development; respiratory

DESCRIPTION (provided by applicant): Hospital-acquired infections are currently one of the biggest concerns within hospitals. There are two million hospital acquired infections annually in US, 90,000 result in death. A typical infection can cost as much as $47,000 per patient to treat. Tubing, respirators and humidifiers are among the devices that can be entry points for and sources of respiratory-associated infections. Airborne bacteria and viruses can cause infection and disease through inhalation and are particularly problematic for patients with weakened immune systems. Sterilization by autoclaving or use of caustic chemicals such as Cidex can be harmful to patients and/or components. Therefore there is a great need for the development of medical components that contain non-toxic antimicrobial agents, which prevent the growth or the colonization of infection causing bacteria on the surface. Upon sharing preliminary data with Respironics, a leading medical device manufacturer and supplier of respiratory ventilators, masks and devices, they became extremely interested in seeing if NanoDynamics's nanosilver-based technology could be utilized in their devices. The overall goal of the project is to address the need for developing new antimicrobial blends for manufacturing respiratory and related medical devices. The main objective is to demonstrate that nanosilver-based technology can be incorporated into medical plastic (both hard and soft type plastics) components such as respirators and masks to provide bacteria-free surfaces that are biocompatible, that does not adversely affect the plastic's mechanical or physical properties, and is cost effective. The use of nanosilver materials translates to high effective surface areas of silver and very low concentrations to obtain desired efficacies, thus minimizing costs. Research on Phase I will be structured in four specific aims. The first aim is the preparation and optimization of the nanosilver-based materials. The second aim is based on dispersability studies of the nanomaterials into plastics. Two types of plastic will be tested, a thermoplastic (polycarbonate) and a liquid injection molding silicone elastomers. After the processing parameters are optimized to obtain the best dispersability, the third aim of the project will next be the focus, which is the determination of the loading levels of the nanosilver-based materials used in the plastics to obtain the best antibacterial properties. The last aim and a very critical one will be to test the biocompatibility of the optimized materials. Phase II studies will naturally follow that will entail molding, testing and evaluating actual components, FDA required testing, and expanding the use of nanosilver for other critical components within the respiratory device. Also, incorporation of the nanosilver-based materials into two other thermoplastics (ethyl vinyl acetate and the opaque DuPont Hytrel) used to manufacture respiratory devices will be investigated. PUBLIC HEALTH REVELANCE: According to the U.S. Centers for Disease Control and Prevention, about 90,000 Americans die each year from hospital-acquired infections. It is essential to understand that any medical device used in long-term care facilities, nursing homes or private homes also has the potential to cause infections if not used, stored, cleaned and disinfect properly. Therefore there is a great need for the development of medical components that contain non- toxic antimicrobial agents, which prevent the growth or the colonization of infection causing bacteria on the surface.

描述（由申请人提供）：医院获得的感染目前是医院中最大的关注点之一。美国每年有200万医院感染，90,000人导致死亡。典型的感染可能需要每位患者47,000美元来治疗。管道，呼吸器和加湿器是可以成为呼吸道相关感染的入口点和来源的设备之一。空气传播的细菌和病毒会通过吸入引起感染和疾病，对于免疫系统疲软的患者尤其有问题。通过高压灭菌或使用苛性化学物质（例如CIDEX）进行灭菌可能对患者和/或组件有害。因此，需要开发含有无毒抗菌剂的医学成分，这些抗菌剂可以防止感染的生长或定植，从而导致表面细菌。在与Respironics共享初步数据后，Respironics是一家领先的医疗设备制造商，呼吸器，口罩和设备的供应商，他们对了解是否可以在其设备中利用纳米动力学的基于纳米层的技术非常感兴趣。该项目的总体目标是满足开发用于制造呼吸和相关医疗设备的新抗菌混合物的需求。主要目标是证明可以将基于纳米垫的技术纳入医用塑料（硬质和软塑料）组件，例如呼吸器和口罩，以提供具有生物相容性的无细菌表面，不会对塑料的机械或物理性质产生不利影响，并且具有成本效益。纳米层材料的使用转化为银的高效表面积和非常低的浓度以获得所需的效力，从而最大程度地减少了成本。第一阶段的研究将以四个特定目标进行结构。第一个目的是制备和优化纳米层的材料。第二个目的是基于将纳米材料分解为塑料的可分散性研究。将测试两种类型的塑料，一种热塑性塑料（聚碳酸酯）和液体注射式硅酮弹性体。在优化处理参数以获得最佳的分散性之后，该项目的第三个目的将是焦点，这是确定塑料中使用的基于纳米胶体的材料的加载水平，以获得最佳的抗菌特性。最后一个目标是测试优化材料的生物相容性。第二阶段的研究将自然进行，这将需要成型，测试和评估实际组件，FDA需要测试，并扩大纳米层在呼吸器设备中其他关键组件的使用。同样，将研究将基于纳米胶体的材料掺入用于生产呼吸器设备的另外两种热塑性塑料（乙酸乙烯乙烯酯和不透明的杜邦Hytrel）中。公共卫生启示：根据美国疾病控制与预防中心的说法，每年约有90,000名美国人因医院获得的感染而死亡。必须了解，在长期护理设施，疗养院或私人住宅中使用的任何医疗设备也有可能导致感染，如果不使用，存储，清洁和正确消毒。因此，非常需要开发含有非毒性抗菌剂的医疗成分，这些抗菌剂可以防止感染的生长或定植，从而导致表面细菌。