A New Low Power Low Cost Ozone Sterilizer for Medical Equipment

描述（由申请人提供）：在本阶段I SBIR中，KWJ Engineering Inc.建议联合收割机将我们多年的臭氧发生和传感技术经验与NIH SBIR计划相结合，以开发用于医疗器械和锐器灭菌的新技术。所提出的技术是重要的，因为该仪器将用作能够净化病毒病原体如HIV、乙型肝炎B和丙型肝炎（HBV、HCV）的微型、低功率和低成本平台。该技术将与NCHHSTP的愿景“开发适当和负担得起的技术，可能有助于解决不安全注射和不安全的尖锐物处理问题”密切相关。特别是，灭菌器仪器将用于实现NCHHSTP目标相关的“……这类技术的例子-不排除其他技术，可能是材料、方法、技术、仪器或装置-包括：（a）用塑料针头取代钢针，以简化尖锐物的处理;（B）无腐蚀性的消毒剂，而没有漂白剂的缺点，或其他设备，对可重复使用的医疗仪器进行有效消毒”。该灭菌器将采用KWJ设计的基于MEMS（微机电系统）的微型等离子体发生器，以紧凑和低功耗设计生产臭氧。申报设计将包括一个带有臭氧传感器（KWJ设计）的灭菌室和过程控制器，以监测灭菌周期后环境暴露前的周期时间和臭氧浓度。所提出的装置将是对商业上可用的技术的显著改进，这是由于易于从大气中产生臭氧及其随后降解为氧气，而不会产生残留副产物或危险物质。目前市场上可用的医疗灭菌器主要是基于蒸汽的，环氧乙烷和过氧化氢等离子体作为其他替代品。基于蒸汽的高压灭菌器虽然有效，但能源密集，而环氧乙烷是一种有毒气体，可能会留下残留物。这些消毒方法虽然适用于医院，但不能用作现场操作的便携式消毒解决方案。此外，其他化学替代品需要补充试剂和定期维护。所提出的设备将是便携式的、重量轻的、具有相对低的功耗和低成本的，几乎不需要维护，并且将可部署用于移动的应用，例如救灾和军事战斗场景，其中需要快速和现场消毒用于现场外科手术。该系统的简单性和多功能性还提供了一种使用臭氧作为主要消毒剂来执行安全的与锐器相关的回收和处置协议的手段，从而解决了与公共健康和安全相关的关于通过经皮锐器损伤传播疾病的关键问题。 公共卫生相关性：建议的臭氧消毒器可以提供一个高效和有效的方法来消毒医疗器械和尖锐物，使用臭氧，一种高活性和广谱的消毒剂。使用微等离子体技术来产生臭氧导致了一种紧凑、低成本和便携式装置，其可以满足对用于对可重复使用的医疗器械进行灭菌以及用于尖锐物处理的有效和通用方法的需求。所得到的装置将大大提高安全性，并降低在暴露于艾滋病毒/艾滋病、肝炎和其他传染病的危险环境中工作时的风险，并且可以在获得常规医疗护理有限的情况下作为医疗从业人员的重要工具，同时易于适用于医疗废物和回收系统，具有快速中和各种病毒、杀微生物剂和杀孢子剂，资源足迹低。

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.