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首页> 外文期刊>Journal of biomedical materials research. Part B, Applied biomaterials. >Plasma-based sterilization: Effect on surface and bulk properties and hydrolytic stability of reprocessed polyurethane electrophysiology catheters
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Plasma-based sterilization: Effect on surface and bulk properties and hydrolytic stability of reprocessed polyurethane electrophysiology catheters

机译:基于等离子体的灭菌:对再加工聚氨酯电生理导管的表面和体积特性以及水解稳定性的影响

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摘要

Plasma-based sterilization is a promising alternative to ethylene oxide (EO) for reprocessing of electrophysiology catheters. To assess its safety in terms of material damage, modifications of surface and bulk properties as well as hydrolytic stability of sterilized catheters were evaluated. Polyurethane (PU) single-use electrophysiology catheters were subjected to one, five, and ten sterilization cycles by Sterrad-100S_ and Plazlyte~(TM), as well as by pure EO for comparison. Surface analysis techniques (ATR-FTIR, XPS, DCA) showed oxidation limited to the near-surface layer induced by both plasma-based sterilizers, whereas EO induced slight but deeper alkylation. Using bulk analysis techniques (RP-HPLC, SEC), oligomer alteration was observed after all three sterilization techniques, without modification of molecular weights. Hydrolytic stability of catheters was slightly changed by plasma-based sterilization, with a small increase in released oligomers. Finally, although P1azlyte and Sterrad are both plasma-based techniques, they induced different impacts on catheters, such as the degradation of an additive with Sterrad, and a clear difference in coloration with Plazlyte.
机译:基于等离子的灭菌是用于电生理导管再处理的有希望的替代环氧乙烷(EO)的方法。为了评估其在材料损坏方面的安全性,评估了灭菌导管的表面和整体性能以及水解稳定性的变化。为了比较,将聚氨酯(PU)一次性电生理导管分别经Sterrad-100S_和PlazlyteTM以及纯EO进行一,五和十次灭菌循环。表面分析技术(ATR-FTIR,XPS,DCA)显示,氧化仅限于两种基于等离子体的灭菌器诱导的近表层,而EO则诱导了轻微但较深的烷基化。使用本体分析技术(RP-HPLC,SEC),在所有三种灭菌技术后均观察到低聚物改变,而分子量没有改变。导管的水解稳定性因基于血浆的灭菌而略有变化,释放的低聚物略有增加。最后,尽管P1azlyte和Sterrad都是基于等离子体的技术,但它们对导管产生了不同的影响,例如Sterrad对添加剂的降解以及Plazlyte在着色方面的明显差异。

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