摘要
目的:测试新型纯热解碳人工机械心脏瓣膜的耐久性,为人工心脏瓣膜寻求更好的替代材料。方法:瓣膜耐久性是瓣膜最关键的性能之一,依据GB12279(ISO5840)标准中的体外耐久性试验方法,将纯热解碳瓣膜与现有同类上市瓣膜进行体外耐久性对照试验,总计4亿次,相当于在人体中工作10年,并对两种瓣膜的瓣架和瓣片进行断裂强度试验。结果:耐久性试验结果表明,两种瓣膜在经过耐久性试验后的变化无统计学差异;断裂强度试验表明,纯热解碳瓣膜断裂强度明显优于含硅瓣膜;瓣膜的磨损程度与瓣架和瓣片的硬度匹配相关性较大。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 durability of the pure pyrocarbon prosthetic heart valve in order to seek a better substitute material for artificial heart valves.Methods:Valve durability is one of the most essential performances of heart valves.According to the in vitro durability test method in the standard of GB12279(ISO5840),the controlled tests of in vitro durability were conducted between the pure pyrolytic carbon valve and the existing similar pyrolytic carbon containing silicon valve for 400 million times in total,equivalent to 10 years of work in the human body.The fracture strength tests on both kinds of valve discs and valve flaps were conducted.Results:The results of durability tests showed that there was no statistical difference between the two valves after the durability test.The result of fracture strength tests indicated that the fracture strength of pure pyrolytic carbon valve was better than that of silicon valves.The wear degree of valve had a great correlation with the hardness matching of valve frame and discs.Conclusion:Pure pyrolytic carbon valve has many advantages.It is not easy to tear and fracture after implantation,since fracture may lead to valve failure.It has better biocompatibility with less pollution and lower cost.It may bring about a better market than the ordinary one.
作者
李海平
刘丽
李佳轩
苏春光
李健
Li Haiping;Liu Li;Li Jiaxuan;Su Chunguang;Li Jian(Lanzhou Lanfei Medical Instrument Co.,Ltd.,Lanzhou 730070,China;National Institutes for Food and Drug Control,Beijing 102629,China;Beihang University,Beijing 100191,China)
出处
《中国药事》
CAS
2022年第3期322-329,共8页
Chinese Pharmaceutical Affairs
