仿生纳米涂层人工骨制造理论与关键技术研究

Due to the toxic side effects, poor biocompatibility, poor corrosion resistance and poor wear resistance of traditional metal artificial bone material, as well as the problems of non-customization, bone loose and non-survival of bone cells of non-metal artificial bone material, this project puts forward a personalized nano-coating bionic artificial bone manufacturing method which is based on the implantable thermoplastic polymers. Employing fluid dynamics theoretical analysis and numerical simulation method, establish the fluid dynamics theoretical model of thermoplastic polymer artificial bone nozzle, and based on the thermodynamic theory of thermoplastic polymers, study the temperature change regular pattern of the ejective material and the cohesive failure, adhesive failure, sticked-material failure and mixed failure of artificial bone, determine the optimal parameter of the forming of thermoplastic polymer artificial bone；based on reverse engineering theory, establish the personalized bionic artificial bone three-dimensional model which is for specific object and has micro-porous structure; conduct thermoplastic polymer artificial bone forming test, develop thermoplastic polymer bionic artificial bone; study the nano-coating manufacturing method of thermoplastic polymer bionic artificial bone, optimize corrosion resistance, fatigue strength of nano-coating and combinative feature of the same vivo bone. On the basis of the theoretical study, develop implantable thermoplastic polymer nano-coating bionic artificial bone which has excellent biocompatibility to alternate metal artificial bone. Our research will improve the accuracy, the combination strength and the life of artificial bone, avoid the harm of metal artificial bone, solve the problems of bone loose and non-survival of bone cells, realize the forming change from common prototype to functional parts, which has important clinical and scientific research significance。

针对传统金属人工骨材料具有毒副作用，生物相容性、抗腐蚀性和耐磨性较差，非金属人工骨成形的非定制化、骨松动、骨细胞不存活等问题，采用可替代金属的可植入热塑性高聚物如碳纤维聚醚醚酮，通过人工骨的仿生建模制造出热塑性高聚物仿生纳米涂层人工骨。采用流体动力学理论分析、仿真优化与实验相结合的方法，建立热塑性高聚物人工骨喷头流体动力学理论模型；结合热塑性高聚物的热力学理论，研究喷出材料温度变化规律和人工骨的内聚破坏、粘附破坏以及混合破坏，确定人工骨成形的最优化参数；基于逆向工程理论，建立特定的具有微细多孔结构的仿生人工骨模型，进行热塑性高聚物人工骨成形试验，研制热塑性高聚物仿生人工骨；揭示热塑性高聚物仿生人工骨纳米涂层成形机理，开发出热塑性高聚物仿生人工骨纳米涂层；在理论研究的基础上研发出可替代金属人工骨并具有优良生物相容性的可植入热塑性高聚物仿生纳米涂层人工骨，具有重要的临床和科学研究意义。

传统金属人工骨材料具有毒副作用，生物相容性、抗腐蚀性和耐磨性较差，非金属人工骨成形非定制化、植入后导致骨松动、骨细胞不存活等问题。针对传统人工骨的不足，本项目以“最佳长期骨移植”材料聚醚醚酮（PEEK）为人工骨基材，采用3D打印技术，并通过物理气象沉积法在聚醚醚酮人工骨表面制备“亲生物金属”钽金属涂层，实现仿生纳米涂层人工骨的制备。通过有限元仿真和实验相结合的方法，建立了热塑性高聚物仿生人工骨喷头流体动力学理论模型和成形样件热力学模型，揭示了热塑性高聚物仿生人工骨成形机理。. 研究了热塑性高聚物通过微细流道精确3D打印的机理。构建并求解了聚醚醚酮熔体流动的控制方程和本构方程，通过流体力学仿真模拟，揭示了熔体内部的运动规律，得到熔体的速度、压力和温度分布，讨论了打印参数对喷头熔体流动性的影响。. 建立了人工骨热塑性高聚物打印过程中的热力学模型，分析热塑性高聚物人工骨的热学特性对成形的粘接质量、力学特性等影响，研究成形过程中温度场的形成，以及成形温度变化对固化过程影响。借助参数化编程语言模拟了样件在3D打印过程中的热行为，揭示了打印条件对样件温度场的影响规律。采用顺序耦合中的间接法，以温度场计算结果为载荷，探索了打印条件对基于温度载荷的3D打印样件热应力耦合场的影响规律。. 建立了仿生纳米涂层人工骨成形方法。通过3D打印技术，制备了热塑性高聚物PEEK人工骨；在此基础上，通过物理气相沉积技术，在热塑性高聚物PEEK人工骨表面制备了纳米钽金属涂层，并综合评价了人工骨的力学性能、生物性能，所制备的生纳米涂层人工骨具有优良的力学性能且具有良好的生物相容性。. 本项目共发表论文5篇，其中SCI检索2篇，EI检索2篇。申报中国发明专利2项，其中已授权发明专利1项。该研究解决传统人工骨制备材料和制备工艺上的难题，提供了仿生聚醚醚酮人工骨3D打印的新思路和新方法。计划与美国佐治亚理工学院合作推进仿生人骨在设计和精确成形领域的研究工作。