3D打印骨小梁髋关节假体材料在体骨修复及离子析出中的应用  

Application of the of 3D Printed Trabecular Hip Prosthesis Material on Bone Repair&Metal Ions Released

作　　者：李雪峰 李家林 梁洁[1] 袁暾[1] 郭天韦 杜珩 连欢 Li Xuefeng;Li Jialin;Liang Jie;Yuan Tun;Guo Tianwei;Du Heng;Lian Huan(National Engineering Research Center for Biomaterials,Sichuan University,Sichuan Testing Center for Biomaterials and Medical Devices,Key Laboratory of Biomaterials and Devices Safety Evaluation,National Medical Products Administration,Chengdu Sichuan 610064,China)

机构地区：[1]四川大学国家生物医学材料工程技术研究中心,四川医疗器械生物材料和制品检验中心,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,四川成都610064

出　　处：《医疗装备》2020年第17期1-6,共6页Medical Equipment

基　　金：国家重点研发计划(2018YFC1106800,2016YFC1103200);四川省重点研发项目(2020YFS0462)。

摘　　要：目的研究3D打印骨小梁髋关节假体的骨整合性能、局部组织反应及体内释放的主要金属离子的风险,为类似3D打印器械的临床前评价提供思路与实例。方法选取49只成年日本大耳白兔构建股骨骨缺损模型后随机分为3组,实验组将3D打印骨小梁髋关节假体材料样品植入两侧股骨缺损区,对照组植入钛基材,假手术组不植入任何材料,于植入术后12、26周观察并取材,通过大体病理、硬组织切片染色等方法观察缺损处新骨形成、骨修复及局部组织反应情况,采用电感耦合等离子体发射光谱法检测实验动物外周血、肝、肾及肌肉组织中的钛、铝、钒金属离子浓度。结果各实验组孔口处均见大量新生骨覆盖,未见股骨断裂、脓肿、出血或其他异常;组织学观察,实验组样品界面上可见大量新骨形成,部分区域骨与材料紧密结合,而对照组骨缺损区域新骨形成量较少,材料与骨之间仍可见明显间隙。实验组的组织反应与对照组相似,按GB/T 16886.6标准均可判定为无刺激。各取材时间点3组体内钛、铝、钒的析出量比较无显著差异,析出的金属离子以铝为主,钛和钒析出较少。结论3D打印钛金属骨小梁髋关节假体材料具有较好的骨整合性能,且局部炎症反应轻,金属离子整体析出较少,但是,相对多的铝离子析出是否会影响其相容性与安全性应该在后续评价中加以考虑。Objective To provide ideas and examples for the preclinical evaluation of similar 3D printed devices,this study investigated the osseointegration,local tissue response and the risk of major metallic ions release of 3D printed trabecular hip prosthesis in animals.Methods Forty-nine adult Japanese white rabbits forming thighbone bone defect models were randomly divided into three groups.The experimental group were implanted the 3D printed trabecular bone hip prosthesis material samples into the femoral defect areas on both sides,the control group with titanium substrates,and sham operation group were not implanted any materials.The bone formation,bone defect repairing and local tissue response in the defect area of each group were observed by gross pathology and staining of hard tissue slicing at 12,26 weeks after the operation.The concentrations of metal ions such as titanium,aluminum and vanadium in peripheral blood,liver,kidney and muscle tissues of experimental animals were detected by inductively coupled plasma emission spectrometer.Results A large amount of new bone covering the orifice of all groups,no femoral fracture,abscess,bleeding or other abnormalities were found.Histological observation showed that a large amount of new bone was formed on the samples'interface of the experimental group,and some areas of the bone were in close contact with the material.While the amount of new bone formed in the bone defect area of the control group was less,and there were still obvious gaps between the material and the bone.The tissue response of the experimental group was similar to that of the control group.According to the standard of GB/T 16886.6,both can be judged as non-irritating.There was no significant difference in the amount of titanium,aluminum,and vanadium released in each group of animals at each sampling point.The released metal ions were consisted of aluminum mainly,and titanium&vanadium less.Conclusion The 3D printed titanium trabecular bone hip prosthesis material has good osseointegration performance

关 键 词：3D打印 骨小梁髋关节假体 骨整合 组织反应 金属离子析出 

分 类 号：R687.4[医药卫生—骨科学]