关节植入物表面多孔涂层形貌结构和耐磨性能的检测研究  

Study on Morphological Structure and Wear Resistance of Porous Coatings on the Surface of Joint Implants

作　　者：李帆 王常斌 高娜 梁金奎 方元 张露文 杨婧 张博 LI Fan;WANG Changbin;GAO Na;LIANG Jinkui;FANG Yuan;ZHANG Luwen;YANG Jing;ZHANG Bo(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Jinan Shandong 250101,China;NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices,Jinan Shandong 250101,China;Shandong Provincial Key Laboratory of Biological Evaluation of Medical Devices,Jinan Shandong 250101,China)

机构地区：[1]山东省医疗器械和药品包装检验研究院,山东济南250101 [2]国家药品监督管理局生物材料器械安全性评价重点实验室,山东济南250101 [3]山东省医疗器械生物学评价重点实验室,山东济南250101

出　　处：《中国医疗设备》2024年第8期38-43,共6页China Medical Devices

基　　金：山东省医疗器械和药品包装检验研究院课题(NB202311)。

摘　　要：目的对关节植入物表面不同工艺多孔涂层的形貌结构和耐磨性能进行分析探讨。方法选取3种等离子喷涂钛涂层样品、1种钛珠烧结涂层样品和1种3D打印多孔涂层样品,按照YY/T 0988.14-2016在金相显微镜下对涂层纵截面的多孔结构进行分析,测量多孔结构的孔隙率和孔隙截距;按照ASTM F1978-22测试样品的耐磨性能,在扫描电子显微镜下观察涂层磨损前后的表面形貌,分析不同工艺和孔隙结构涂层的磨损行为和磨损机理。结果几种涂层的孔隙率在30%~60%范围内,孔隙截距在100~510μm之间,符合美国食品药品监督管理局的法规要求,钛珠烧结涂层和3D打印多孔涂层的孔隙连通性优于等离子喷涂涂层;等离子喷涂涂层的磨损过程为颗粒脱落伴随着磨粒磨损,钛珠烧结涂层和3D打印多孔样品的磨损过程主要为磨粒磨损。结论耐磨性能的差异与涂层工艺、孔隙率和结构形式存在显著关系。Objective To analyze and explore the morphological structure,and wear resistance of porous coatings with different processes on the surface of joint implants.Methods Three types of plasma sprayed titanium coating samples,one type of titanium bead sintered coating sample,and one type of 3D printed porous structure sample were selected.The porous structure of the surface coating of the samples were analyzed according to YY/T 0988.14-2016,and the porosity and pore intercept of the porous structure were measured on the longitudinal section of coating under metallographic microscope.And the wear resistance of the samples were tested according to ASTM F1978-22.The surface morphology of the coating before and after wear were observed under a scanning electron microscope,and the wear behavior and wear mechanism of coatings with different processes and pore structures were analyzed.Results The porosity of several coatings ranged from 30%to 60%,with a pore intercept between 100 and 510μm,in compliance with FDA regulations,the pore connectivity of titanium bead sintered coatings and 3D printed porous coatings were better than that of plasma sprayed coatings.The wear process of plasma sprayed coatings was characterized by particle detachment accompanied by abrasive wear,while the wear process of titanium bead sintered coatings and 3D printed porous samples was mainly characterized by abrasive wear.Conclusion The difference in wear resistance is significantly related to coating process,porosity,and structural form.

关 键 词：等离子喷涂 3D打印 涂层形貌 耐磨性能 

分 类 号：R197.39[医药卫生—卫生事业管理] TG178[医药卫生—公共卫生与预防医学]