中国医疗设备2018,Vol.33Issue(9):19-22,27,5.DOI:10.3969/j.issn.1674-1633.2018.09.005
植入式磁液悬浮心室辅助装置的动物长期体内评价研究
Extended in Vivo Evaluation of the Implantable Magnetic-Hydrodynamic Suspension Ventricular Assist Device
摘要
Abstract
Objective To verify the safety and reliability of implantable magnetic-hydrodynamic suspension ventricular assist device in long-lived left ventricular assisted animals. Methods The appropriate animals were selected appropriately to establish standard operating procedures (SOPs) for animal care during preoperative, intraoperative, and postoperative operation according to the relevant laws and regulations at home and abroad, as well as professional experience. An animal welfare system was established based on 3R (refinement, reduction and replacement) principle. Results The left ventricular assist device was implanted in an ovine (n=6) model to achieve a long-term healthy survival for more than 95 days. The implantable magnetic-hydrodynamic suspension ventricular assist devices were successfully implanted and showed excellent support with no mechanical failures throughout the implant period. Conclusion The experimental animals have been rationally selected, and the surgical and nursing SOPs are standardized. The implanted animals at stable physiological status show that the implantable magnetic-hydrodynamic suspension ventricular assist device with good performance have reached the pre-clinical application level.关键词
心室辅助装置/动物实验/质量控制/心力衰竭Key words
implantable magnetic-hydrodynamic suspension ventricular assist device/in vivo evaluation/quality control/cardiac failure分类
医药卫生引用本文复制引用
许剑,范庆麟,朱尘琪,赵廷彪,刘晓程,刘志刚,陈铁男,张杰民..植入式磁液悬浮心室辅助装置的动物长期体内评价研究[J].中国医疗设备,2018,33(9):19-22,27,5.基金项目
国家重点研发计划(2016YFC0103203). (2016YFC0103203)