聚乙烯髋臼内衬300万次和500万次体外磨损性能研究  

In-Vitro Analysis of Polyethylene Liner Wear Performance at 3 and 5 Million Cycles

作　　者：闫师通 王建军 苏健 YAN Shitong;WANG Jianjun;SU Jian(Beijing Institute of Medical Device Testing,Beijing,101111)

机构地区：[1]北京市医疗器械检验研究院,北京市101111

出　　处：《中国医疗器械杂志》2024年第4期467-472,共6页Chinese Journal of Medical Instrumentation

基　　金：国家重点研发计划项目(2016YFC1101904)。

摘　　要：目的 分析超高分子量聚乙烯髋臼内衬经历300万次(3 Mc)和500万次(5 Mc)体外磨损测试后磨损性能的差异,为髋关节假体体外测试试验设计作参考,并为临床翻修取出物作对照。方法 使用髋关节模拟机,对内径为28 mm、32 mm、36 mm三种规格的髋臼内衬进行磨损测试,计算3 Mc和5 Mc磨损后的磨损量;分析磨屑颗粒的数量、大小和形状。结果 经历3 Mc、5 Mc磨损后,髋臼内衬磨损量随内径的增大而增多;磨屑颗粒的等效圆面积直径(equivalent circular diameter, ECD)平均值为0.27μm、0.29μm,体态比(AR)小于4的占比为94.4%、90.1%。结论 髋臼内衬经历3 Mc磨损后的磨损量可以反映出产品的磨损性能趋势;相比于3 Mc磨损,经历5 Mc磨损后颗粒数量增多、纤维状颗粒占比升高。Objective The purpose of this study is to compare the wear properties of UHMWPE acetabular liners after undergoing 3 million(3 Mc)and 5 million(5 Mc)cycles of in-vitro wear testing.The results will serve as a reference for the design of in-vitro testing for hip prostheses and as a control for clinical revision removals.Methods Wear tests were conducted on three different sizes of acetabular liners(28 mm,32 mm,and 36 mm internal diameters)using a hip simulator to determine the amount of wear after 3 and 5 million cycles.The analysis included the number,size,and shape of abrasive particles.Results After 3 and 5 million cycles of wear,the amount of wear on the acetabular liner increased as the inner diameter increased.The abrasive particles had an average equivalent circular area diameter(ECD)of 0.27μm and 0.29μm,and 94.4%and 90.1%of the aspect ratio(AR)less than 4.Conclusion The amount of wear on the acetabular liner after 3 Mc wear can indicate the wear performance of the product.The number of particles increased and the percentage of fibrous particles was higher after 5 Mc wear compared to 3 Mc wear.

关 键 词：超高分子量聚乙烯 磨损性能 磨损量 磨屑分析 

分 类 号：R95[医药卫生—药学]