通过医疗等级的聚乙扩散过氧化:分析吸附和运输机制,以支持用蒸汽相过氧化进行绝育
Ioan P I Gitsov1, Yunzhi Liu2, David M Saylor2
1Global Technology and Innovation, Medtronic Inc, Minneapolis, Minnesota, USA.
概括
蒸汽相过氧化 (VH2O2) 灭菌现已获得FDA批准用于医疗器械. 这项研究量化了VH2O2通过聚乙的扩散,证明了其快速透,用于植入式设备的有效杀菌.
科学领域:
- 材料科学 材料科学 材料科学
- 生物医学工程 生物医学工程
- 化学工程是化学工程的重要组成部分.
背景情况:
- 美国FDA现在承认蒸汽相过氧化 (VH2O2) 是A类绝育剂,类似于乙烯氧化物 (EO).
- 植入式医疗器械的有效杀菌需要杀菌剂通过设备材料透到密封组件.
- 虽然EO扩散已经很成熟,但VH2O2透设备材料的能力仍然在很大程度上没有特征.
研究的目的:
- 为量化VH2O2在医疗器械中常用的聚乙 (PEU) 中的扩散和透性.
- 根据材料透率,评估植入器件VH2O2杀菌的可行性.
主要方法:
- 测量了具有不同耐久度的PEU (PEU75D,PEU55D,PEU80A) 的VH2O2扩散性和透性.
- 数学建模用于计算扩散系数和透性.
- 用测量参数估计了典型的医疗的透时间.
主要成果:
- 对VH2O2的扩散系数在1 × 10-8 cm2/s (PEU75D) 到5 × 10-8 cm2/s (PEU80A) 之间.
- 透度计算为4.7×10−6厘米2秒 (PEU55D) 和1.3×10−5厘米2秒 (PEU80A).
- 通过0.013厘米的PEU80A壁 (典型的厚度) 的VH2O2透发生在10分钟以下.
结论:
- 通过常见的医疗器械聚乙,VH2O2显示出足够的扩散性和透性.
- 快速透表明VH2O2是可移植设备的可行的灭菌方法,与现有的循环时间兼容.
- 这项研究支持在医疗器械行业中扩大VH2O2杀菌的使用.
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