Study on Biocompatibility of a Novel Uterine Tamponade Balloon Catheter
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
Abstract：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.
刘康博，周静，孟星，柳小军，张丹丹，韩颖，周小婷，徐玉茵，田林奇. 一种国产新型子宫填塞球囊导管的生物相容性研究[J]. 中国医疗设备, 2020, 35(5): 66-69.
LIU Kangbo, ZHOU Jing, MENG Xing, LIU Xiaojun, ZHANG Dandan, HAN Ying, ZHOU Xiaoting, XU Yuyin, TIAN Linqi. Study on Biocompatibility of a Novel Uterine Tamponade Balloon Catheter. China Medical Devices, 2020, 35(5): 66-69.
