摘要
目的对一种国产新型的子宫填塞球囊导管进行生物相容性评价,为其在临床上的安全应用提供依据。方法采用体外细胞毒性试验、皮肤致敏试验、皮内反应试验、阴道刺激试验、溶血试验和热原试验等方法,对子宫填塞球囊导管的生物学性能进行评价。结果该球囊导管的细胞存活率为86%,无潜在的细胞毒性;该球囊导管无皮肤致敏性、皮内反应及阴道组织刺激反应;该球囊导管的溶血率为0.3%;家兔的体温升高之和为0.1℃,无热原反应。结论该国产新型子宫填塞球囊导管符合国家相关标准,具有良好的生物相容性,为其临床的安全应用提供了可靠保障。
Objective To evaluate the biocompatibility of a novel uterine tamponade balloon catheter,which provides a basis for its safe application in clinical practice.Methods The biological properties of the uterine tamponade balloon catheters were investigated by in vitro cytotoxicity test,skin sensitization test,intradermal reaction test,vaginal irritation test,hemolysis test and pyrogen test.Results The cell survival rate was 86%,suggesting no potential cytotoxicity.The balloon catheter had no skin sensitization,intradermal reactions,and vaginal irritation response.The hemolysis rate of the balloon catheter was 0.3%.The sum of body temperature rise of rabbits was 0.1℃,suggesting no pyrogen reaction.Conclusion The novel uterine tamponade balloon catheter complies with the relevant national standards and has good biocompatibility,which provides a reliable guarantee for its clinical application.
作者
刘康博
周静
孟星
柳小军
张丹丹
韩颖
周小婷
徐玉茵
田林奇
LIU Kangbo;ZHOU Jing;MENG Xing;LIU Xiaojun;ZHANG Dandan;HAN Ying;ZHOU Xiaoting;XU Yuyin;TIAN Linqi(Biological Testing Room,Henan Medical Equipment Inspection Institute(Henan Medical Equipment Inspection and Testing Engineering Technology Research Center,Henan Medical Equipment Biotechnology and Application Engineering Research Center),Zhengzhou Henan 450000,China)
出处
《中国医疗设备》
2020年第5期66-69,74,共5页
China Medical Devices
基金
河南省科技攻关项目(182102311117)。
关键词
生物相容性
子宫填塞球囊导管
细胞毒性
硅橡胶
阴道刺激
biocompatibility
uterine tamponade balloon catheter
cytotoxicity
silicone
vaginal irritation
