Plasma Sterilization Device Compatible with Long-Lumen Scopes

与长腔镜兼容的等离子体灭菌装置

• 批准号: 10604164
• 负责人: Yue Xiao
• 金额: $ 20万
• 依托单位: ADVANCED COOLING TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10604164
• 关键词: Plasma; Sterilization; Device; Compatible; Long

Abstract Ethylene Oxide (EtO) sterilization is the most common method that effectively sterilizes many types of medical equipment, especially those that are heat-sensitive, made from certain polymers, or with long lumens. However, EtO systems suffer from the long sterilization time, high cost, the high toxicity of EtO, and negative environmental impacts. As a promising alternative, hydrogen peroxide gas plasma (HPGP) sterilization eliminates most of the above disadvantages, but the HPGP cannot sterilize narrow or long lumens of medical scopes due to the suppressed gas diffusion deep inside the lumen, limiting its potential to completely replace EtO. In addition, HPGP sterilization may fail if a thorough drying and careful loading of the equipment were not performed. To develop an equivalent or improved solution to EtO while retaining the advantages of HPGP, Advanced Cooling Technologies, Inc. (ACT), in collaboration with Rutgers University (RU), proposes an ozone plasma sterilization system with plasma-in-lumen technology. The system uses air to generate plasma containing strong sterilizing agents such as ozone (O3) and hydroxyl radicals at near-atmospheric pressure. The plasma is generated inside a sterilization pouch that is made from reusable and flexible sheet plasma generators to reduce sterilization time and system weight. Additionally, the system has an innovative thin-tubing plasma generator that can be directly inserted into the long lumens of surgical scopes to supply ozone, fundamentally eliminating the lumen length limits of the current HPGP systems. The system will accommodate multiple pouches at once to increase sterilization throughput. Further, the ozone sterilization can operate without thorough drying, and the insulation layer on the sheet plasma generator can eliminate failure due to improper loading.

抽象的 环氧乙烷 (EtO) 灭菌是最常用的方法，可对多种类型的医疗物品进行有效灭菌。 设备，特别是那些热敏、由某些聚合物制成或具有长流明的设备。然而， EtO系统存在灭菌时间长、成本高、EtO毒性大、对环境不利等问题。 影响。作为一种有前途的替代方案，过氧化氢气体等离子体 (HPGP) 灭菌消除了大部分 上述缺点，但 HPGP 无法对狭窄或长管腔的医用内窥镜进行消毒，因为 抑制了气体在管腔深处的扩散，限制了其完全替代 EtO 的潜力。此外， 如果未对设备进行彻底干燥和小心装载，HPGP 灭菌可能会失败。 为了开发 EtO 的等效或改进的解决方案，同时保留 HPGP、Advanced Cooling Technologies, Inc. (ACT) 与罗格斯大学 (RU) 合作，提出了臭氧等离子体 采用腔内等离子体技术的灭菌系统。该系统使用空气产生含有强等离子体的等离子体 臭氧 (O3) 和接近大气压的羟基自由基等灭菌剂。等离子体是 在由可重复使用的柔性片状等离子体发生器制成的灭菌袋内产生，以减少 灭菌时间和系统重量。此外，该系统还具有创新的细管等离子体发生器 可以直接插入手术镜的长管腔中供应臭氧，从根本上消除 当前 HPGP 系统的流明长度限制。该系统将同时容纳多个袋子 以提高灭菌吞吐量。此外，臭氧灭菌无需彻底干燥即可进行，并且 片状等离子体发生器上的绝缘层可以消除由于加载不当而导致的故障。