A New Low Power Low Cost Ozone Sterilizer for Medical Equipment

用于医疗设备的新型低功率低成本臭氧灭菌器

• 批准号: 8411110
• 负责人: Joseph R. Stetter
• 金额: $ 12.98万
• 依托单位: KWJ ENGINEERING, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-17 至 2014-03-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8411110
• 关键词: AIDS/HIV problem; Address; Adenoviruses; Air; Area; Bacteriophages; Caring; Chemicals; Communicable Diseases; Consumption; Data; Decontamination; Devices; Disadvantaged; Disasters; Disinfectants; Engineering; Enterovirus; Environment; Equipment; Ethylene Oxide; Evaluation; Exclusion; Exposure to; Gases; Generations; HIV; Hepatitis; Hepatitis B; Hepatitis B Virus; Hepatitis C; Hepatitis C virus; Herpesviridae; Hospitals; Humidity; Hydrogen Peroxide; Injection of therapeutic agent; Left; Maintenance; Marketing; Medical; Medical Waste; Methodology; Methods; Military Personnel; Modeling; Monitor; Needles; Operative Surgical Procedures; Oxygen; Ozone; Phase; Plasma; Plastics; Problem Solving; Process; Production; Protocols documentation; Public Health; Reagent; Recycling; Residual state; Resources; Risk; Safety; Sharps Injury; Site; Small Business Innovation Research Grant; Solutions; Steam; Steel; Sterilization; System; Techniques; Technology; Temperature; Testing; Time; United States National Institutes of Health; Viral; Virus; Work; base; combat; cost; data acquisition; design; disease transmission; experience; instrument; light weight; microbicide; model design; new technology; novel; operation; pathogen; performance tests; programs; prototype; research study; sensor; tool; vision development; voltage

DESCRIPTION (provided by applicant): In this Phase I SBIR, KWJ Engineering Inc. proposes to combine our years of experience with ozone generation and sensing technology with the NIH SBIR program to develop novel technology for the sterilization of medical instruments and sharps. The proposed technology is significant since the instrument will serve as a miniature, low power and low cost platform capable of decontamination of viral pathogens such as HIV, Hepatitis B and Hepatitis C (HBV, HCV). The technology will be closely aligned with the NCHHSTP vision of "Development of appropriate and affordable technologies that may contribute to solving the problems of unsafe injection and unsafe sharps disposal". In particular, the sterilizer instrument will serve to fulfill NCHHSTP objectives related to "...Examples of such technologies -- not to the exclusion of others, which may be materials, methods, techniques, instruments, or devices - include: a) plastic needles to replace steel ones to simplify sharps disposal; b) noncorrosive sterilants without the disadvantages of bleach, or other equipment for effective sterilization of reusable medical instruments". The sterilizer will incorporate a KWJ designed MEMS (Micro-Electromechanical Systems) based micro-plasma generator for the production of ozone in a compact and low-power design. The proposed design will incorporate a sterilization chamber with ozone sensors (KWJ designed) and process controller to monitor cycle time and ozone concentration prior to ambient exposure after the sterilization cycle. The proposed device will be a marked improvement over technologies that are commercially available due to the ease of ozone generation from atmospheric air and its subsequent degradation to oxygen with no generation of residual by- products or hazardous species. Medical sterilizers available on the market today are primarily steam-based, with ethylene oxide and hydrogen peroxide plasma as other alternatives. Steam-based autoclaves, while effective, are energy intensive, while ethylene oxide is a toxic gas and can leave behind residuals. These sterilization methods, while adaptable for hospitals, cannot be used as portable sterilization solutions for field operations. In addition, other chemical alternatives require replenishing of reagents and regular maintenance. The proposed device will be portable, light-weight, with relatively low power consumption and low cost, requiring virtually no maintenance and will be deployable for mobile applications such as disaster relief and military combat scenarios where rapid and on-site sterilization is required for field surgical procedures. The simplicity and versatility of the system also provide a means to implement safe sharps-related recycling and disposal protocols using ozone as the primary disinfectant, thereby addressing a critical area of concern regarding transmission of diseases through percutaneous sharps injuries as related to public health and safety. PUBLIC HEALTH RELEVANCE: The proposed ozone sterilizer can provide an efficient and effective means to decontaminate medical instruments and sharps with the use of ozone, a highly reactive and broad-spectrum disinfectant. The use of micro-plasma technology to create ozone leads to a compact, low-cost and portable device that can fulfill the need for an effective and versatile methodology for sterilizing re-usable medical instruments as well as for sharps disposal. The resulting device will greatly increase safety and reduce risk when working in environments that pose danger of exposure to HIV/AIDS, Hepatitis and other infectious diseases, and can serve as a crucial tool for medical practitioners in situations where access to regular medical care is limited, while being easily adaptable for medical waste and recycling systems, with the capability of rapidly neutralizing myriad viral, microbicidal and sporicidal agents, with a low resource footprint.

描述（由申请人提供）：在这个一期SBIR中，KWJ工程公司提议将我们多年来在臭氧产生和传感技术方面的经验与NIH SBIR项目结合起来，开发用于医疗器械和利器灭菌的新技术。该提议的技术意义重大，因为该仪器将作为一种微型、低功耗和低成本的平台，能够净化病毒病原体，如HIV、乙型肝炎和丙型肝炎（HBV、HCV）。该技术将与NCHHSTP“开发可能有助于解决不安全注射和不安全尖锐物处置问题的适当和负担得起的技术”的愿景密切一致。特别是，灭菌器仪器将用于实现NCHHSTP与“…这些技术的例子——不排除其他技术，可能是材料、方法、技术、仪器或设备——包括：a)用塑料针代替钢针，简化利器的处理；B)无腐蚀性灭菌剂，无漂白剂的缺点，或其他可重复使用的医疗器械的有效灭菌设备”。该灭菌器将采用KWJ设计的基于MEMS（微机电系统）的微等离子体发生器，以紧凑和低功耗的设计生产臭氧。拟议的设计将包括一个带有臭氧传感器的灭菌室（KWJ设计）和过程控制器，以监测灭菌周期后环境暴露之前的循环时间和臭氧浓度。由于臭氧易于从大气中产生并随后降解为氧气，而不会产生残余副产物或有害物质，因此拟议的设备将是对商业可用技术的显著改进。目前市场上可用的医用消毒器主要以蒸汽为基础，环氧乙烷和过氧化氢等离子体作为其他替代品。蒸汽基高压灭菌器虽然有效，但能耗高，而环氧乙烷是一种有毒气体，可能会留下残留物。这些灭菌方法虽然适用于医院，但不能用作野战行动的便携式灭菌溶液。此外，其他化学替代品需要补充试剂和定期维护。该设备便携、重量轻、功耗低、成本低，几乎不需要维护，可部署在灾害救援和军事作战场景等移动应用中，在这些场景中，现场外科手术需要快速和现场消毒。该系统的简单性和多功能性还提供了一种手段，可以使用臭氧作为主要消毒剂实施与安全尖锐物有关的回收和处置方案，从而解决与公共卫生和安全有关的通过经皮尖锐物伤害传播疾病的关键关切领域。