一款国产置入式心室辅助装置动物在体研究  

In vivo evaluation of a domestic implantable ventricular assist device

作　　者：吴广辉[1] 蔺嫦燕[1] 徐创业[1] 刘修健[1] 侯晓彤[1] 李海洋[1] 王景[1] 陈琛 杨朋 渠文波 

机构地区：[1]北京市心肺血管疾病研究所首都医科大学附属北京安贞医院,100029 [2]苏州同心医疗器械有限公司,100029

出　　处：《中华胸心血管外科杂志》2016年第4期238-241,共4页Chinese Journal of Thoracic and Cardiovascular Surgery

基　　金：国家高技术研究发展计划（863计划）（2012AA041605）,首都卫生科研发展专项基金（2011-1005-02）

摘　　要：目的通过实验动物在体研究，评估置入式左心室辅助装置的血液相容性、生物适应性、工作性能及可靠性。方法在心脏不停跳的情况下，采用左心尖到血泵再到降主动脉的循环旁路，在6只健康绵羊体内置入心室辅助装置，进行在体30天辅助实验。期间定期抽血检验血液学指标，实验结束后取主要脏器做尸检宏观和病理学检查。结果6例在体研究达到实验预期。血液学指标检查结果均值在正常范围内。尸解后血泵内部、流出道及吻合口无肉眼可见血栓，病理结果提示除了小部分左肺组织有小叶肺炎外，其余主要脏器均无病灶。结论实验心室辅助装置具有良好的在体血液相容性、生物适应性，工作性能可靠。Objective To evaluate the hemocomaptiblity, biocompatibility, performance and reliability of a left ventric- ular assist device in vivo. Methods The VADS were implanted into 6 healthy sheep without stopping the beating heart by con- structing blood bypass of left ventricle-ventrieular assist device-descending aorta and worked for up to 30 days. Blood sam- pies were collected until elective termination and were performed for chemistry, hematology and coagulation profiles. After ter- mination, we examined whether there was thrombosis in blood pump, grafts and anastomotic stoma. Macroseopical and his- topathologieal examinations were performed in major organs to check for congestion and infarction. Results All 6 sheep sur- vived for 30 days without any complications. Hematology results were within the normal ranges. There were no formations of thrombi and blood clots inside the pump, in outflow grafts and anastomotic sites in all cases. Pathological analysis showed no lesions in main end-stage organs except for slight lobular pneumonia in some left lung tissues. Conclusion The ventricular as- sist device showed considerable in vitro and in vivo blood compatibility, biocompatibility, performance and reliability.

关 键 词：心室辅助装置 动物实验 材料试验 

分 类 号：R541.6[医药卫生—心血管疾病] R-332[医药卫生—内科学]