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植入式磁液悬浮心室辅助装置的动物长期体内评价研究

许剑 范庆麟 朱尘琪 赵廷彪 刘晓程 刘志刚 陈铁男 张杰民

中国医疗设备2018,Vol.33Issue(9):19-22,27,5.
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

许剑 1范庆麟 1朱尘琪 1赵廷彪 1刘晓程 2刘志刚 2陈铁男 2张杰民2

作者信息

  • 1. 航天泰心科技有限公司,天津 300457
  • 2. 泰达国际心血管病医院 心外科,天津 300457
  • 折叠

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)

中国医疗设备

OACSTPCD

1674-1633

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