人工关节植入物涂层力学性能评价

Evaluation of Mechanical Properties of Coatings for Artificial Joint Implants

目的对多孔型人工关节植入物的涂层性能(包括涂层形貌和涂层力学性能)进行分析,总结目前主流产品的涂层性能范围,为新产品的设计研发提供参考,同时为远期植入物取出分析提供依据。方法试验中所用的涂层表面形貌、剪切强度和拉伸强度样品,分别按照ASTM F1854、ASTM F1044和ASTM F1147标准制备,涂层采用等离子喷涂技术加工。共对17套件产品(编号1~17号)的涂层表面形貌(涂层厚度、孔隙率和孔隙截距)进行试验;对编号为1~7号和15、16号产品,首先按照ASTM F1044的试验方法,进行涂层与基体之间的剪切强度试验;然后按照ASTM F1147的试验方法,进行涂层与基体之间的拉伸强度试验。对编号为17的产品,按照ASTM F1044和ASTM F1147的试验方法,分别测试复合涂层和单纯钛涂层的剪切和拉伸强度。结果全部产品中,共15套产品(占比88.2%)涂层厚度300~500μm;金属涂层的产品共16套(编号1~16),其中11套(占比68.75%)涂层孔隙率30%~50%,14套(占比87.5%)涂层孔隙截距50~150μm;涂层的力学性能与基体材质无关;添加羟基磷灰石(HA)后的复合涂层的剪切强度和拉伸强度与纯金属涂层相比,均明显降低。结论针对多孔涂层人工关节的设计制造,其涂层的性能可以参考以下指标:涂层厚度300~500μm,涂层孔隙率30%~50%,涂层孔隙截距50~150μm;可以根据产品的用途选择基体材质;在设计含有HA的复合涂层的植入物时,应考虑结合力较低对产品性能的影响。该性能指标范围能够为远期临床取出物分析提供对照。

Objective To analyze coating properties of porous artificial joints,including coating morphology and coating mechanical properties,and summarize the range of coating properties of current mainstream products,to provide references for the design and development of new products,as well as provide the basis for the long-term implant removal analysis.Methods Samples for the surface morphology,shear strength,and tensile strength of the coatings used in the experiment were prepared in accordance with ASTM F1854,ASTM F1044,and ASTM F1147 standards,respectively.The coatings were processed using plasma spraying.The surface morphology(coating thickness,porosity,and pore intercept)of the coatings for all 17 products(Nos.1-17)was tested;for products Nos.1-7 and Nos.15-16,the shear strength test between the coating and substrate was conducted first in accordance with the test method of ASTM F1044.Then,according to the test method of ASTM F1147,the tensile strength test between the coating and substrate was conducted.For product No.17,the shear and tensile strengths of the composite coating and simple titanium coating were tested,respectively,according to the test method of ASTM F1044 and ASTM F1147.Results A total of 15 products(88.2%)had coating thicknesses between 300μm and 500μm.There were 16 metal-coated products(Nos.1-16),of which 11(68.75%of the total)had coating porosities between 30%and 50%,and 14(87.5%of the total)had coating pore intercepts between 50μm and 150μm.The mechanical properties of the coatings were independent of the substrate material used.The shear and tensile strengths of the composite coatings with hydroxyaptite(HA)were significantly lower than those of the pure metal coatings.Conclusions For the design and manufacture of artificial joints with porous coatings,the performance of the coating can be referred to the following indexes:the coating thickness is 300-500μm,the coating porosity is 30%-50%,the coating pore intercept is 50-150μm.The substrate materials can be selected based on the use of the product.The effects of a lower bonding force on product performance should be considered when designing prostheses with composite coatings containing HA.This range of performance metrics provides control for long-term clinical extraction analyses.