纯热解碳人工机械心脏瓣膜体外性能试验  

In Vitro Performance of Pure Pyrocarbon Prosthetic Heart Valve

作　　者：李海平 刘丽[2] 苏春光 LI Haiping;LIU Li;SU Chunguang(Lanzhou Lanfei Medical Instrument Co.,Ltd.,Lanzhou Gansu 730070,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]兰州兰飞医疗器械有限公司,甘肃兰州730070 [2]中国食品药品检定研究院,北京102629

出　　处：《中国医疗设备》2022年第6期29-34,共6页China Medical Devices

摘　　要：目的测试纯热解碳人工机械心脏瓣膜的体外性能,为人工心脏瓣膜寻求更好的替代材料。方法依据GB 12279标准中的体外加速疲劳试验方法,将纯热解碳瓣膜与现有同类含硅热解碳瓣膜进行体外耐久性对照试验,经4亿多次启闭循环,并对两种瓣膜的瓣架和瓣片进行断裂强度试验。结果两种瓣膜在经过耐久性试验后的变化差异较小,纯热解碳瓣片的断裂压力和断裂时的断裂强度、变形量均比含硅热解碳瓣片数值有明显提升,断裂压力平均值提升超过26%,断裂时变形量提升超过27%。结论纯热解碳瓣膜具有以下优势:植入体内后不易产生撕裂、断裂等导致瓣膜失效的情况;具有更好的生物相容性;污染少、生产成本低,将会比普通瓣膜具有更好的市场前景。Objective To test the performance in vitro of the pure pyrocarbon prosthetic heart valve,so as to seek a better substitute material for artificial heart valve.Methods According to the accelerated fatigue test method in vitro in the standard of GB 12279,the in vitro durability test of pure pyrocarbon valve and existing similar silicon pyrolytic carbon valve was carried out.After more than 400 million cycles of opening and closing,the fracture strength test of the valve frame and the valve plate of the two valves was conducted.Results The result of durability tests showed that there was no statistical difference between the two valves after the durability test.The fracture pressure,fracture strength and deformation of pure pyrocarbon discs were significantly increased compared with those of silicon pyrocarbon discs.The average fracture pressure increased by more than 26%,and the deformation at fracture increased by more than 27%.Conclusion The pure pyrocarbon valves have the following advantages:uneasy to tear or fracture after implantation,which may lead to valve failure;better biocompatibility;with less pollution and lower production costs,which may bring about a better market prospect than ordinary ones.

关 键 词：纯热解碳人工机械心脏瓣膜 体外性能试验 耐久性试验 断裂强度 

分 类 号：R654.2[医药卫生—外科学]