1.北京航空航天大学 生物与医学工程学院;2.北京市医疗器械检验研究院;3.上海交通大学 生物医学工程学院
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，进行分析研究，总结出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对照依据。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，分别测试复合涂层的剪切拉伸强度和单纯钛涂层的剪切拉伸强度。结果 全部产品中，共15套产品（占比88.2%）涂层厚度在300~500μm之间；金属涂层的产品共16套（编号1~16），其中11套（占比68.75%）涂层孔隙率在30%~50%之间，14套（占比87.5%）涂层孔隙截距在50~150μm之间；涂层的力学性能与基体材质无关；添加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：涂层厚度为300~500μm；涂层孔隙率为30%~50%；涂层孔隙截距为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依据。
Objective To analyze and study the coating properties of porous artificial joints, including coating morphology and coating mechanical properties, and to summarize the range of coating properties of the current mainstream products, so as to provide a reference for the design and development of new products, and at the same time, to provide a basis for control for the analysis of implant removal in the long term. Methods The surface morphology, shear strength, and tensile strength samples of the coatings used in the experiment were respectively prepared in accordance with ASTM F1854, ASTM F1044, and ASTM F1147. The coatings were processed using plasma spraying technology. In accordance with the test method of ASTM F1854, the surface morphology (coating thickness, porosity and pore intercept) of the coatings of all 17 products (No. 1~17) were tested; for products No. 1~7 and No. 15 and 16, the shear strength test between the coating and the substrate was conducted firstly in accordance with the test method of ASTM F1044; and then in accordance with the test method of ASTM F1147, the shear strength test between the coating and the substrate was conducted. Then, according to ASTM F1147, conduct the tensile strength test between the coating and the substrate. For product number 17, the shear tensile strength of the composite coating and the shear tensile strength of the simple titanium coating were tested according to the test methods of ASTM F1044 and ASTM F1147, respectively. RESULTS A total of 15 products (88.2% of the total) had coating thicknesses between 300 ~500μm; there were 16 metal-coated products (No. 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 related to the The mechanical properties of the coatings were independent of the matrix material; the shear and tensile strengths of the composite coatings with the addition of HA were significantly lower compared with those of the pure metal coatings. Conclusion For the design and manufacture of artificial joints with porous coating, the performance of the coating can refer 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 material can be selected according to the use of the product; the effect of the lower bonding force on the performance of the product should be taken into account when designing prostheses with composite coatings containing HA. This range of performance metrics can provide a control for the analysis of distant clinical extracts.