股骨颈骨折修复用内固定高孔隙Ti-Nb基生物材料研究

Femur neck fracture (FNF) is a frequently important osseous tissue disease. Generally, retaining femur internal fixation is regarded as a significant surgery to treat FNF disease. However, the metal materials implants used in clinical therapy is not satisfied with stabilization of the interface between the human bone and the implant, or the mismatch of elasticity modulus, or toxicity of the elemental contained in the materials. Therefore, it is significant in clinical therapy to develop a new type of internal fixation metal to meet the requirements mentioned above. In view of the advantages of excellent biocompatibility, mechanical properties and containing non-toxic elemental, according to pre-existing work it is probably promising that the highly porous Ti-Nb based alloys can be successfully prepared with the highly porosity of 40-80%, similar elasticity modulus to human femur bone with the pore size of 300-600μm, and containing non-toxic elemental, utilizing impregnation method and powder metallurgy (P/M) method in combination. The principle of preparation processing and microstructure and properties of the material is further underlying undertaken. It is endeavored to reveal the basic rules of pore structure influence on elasticity modulus of the materials. Finally, their interaction effects of interfaces between porous Ti-Nb based alloys with different pore surface and the biological tissue is deeply explored. Scientific evaluation methods are also utilized to evaluate Ti-Nb based alloys and tissues. It is potential underlying applications for offering considerable new materials to smooth away the thorny difficult problem of FNF disease.

股骨颈骨折是一种常发性重要骨组织疾病。保留股骨头开放复位内固定手术是治疗股骨颈骨折的重要方式，现有临床用内植物金属材料或因骨-植入体界面稳定性不佳或因弹性模量不匹配或因元素毒性等问题，应用效果不理想。因此，制备满足以上要求的金属内固定材料在临床应用中具有重要意义。本项目基于Ti-Nb基合金具有优良的生物相容性，力学性能和不含毒性元素的特点，在已有研究基础上，采用模板浸渍法和粉末冶金法相结合研究制备孔隙度达40-80%、具有引导骨组织内生的孔隙结构（孔径300-600μm）、弹性模量与人体股骨适配以及不含毒性元素的多孔Ti-Nb基生物材料。探索材料制备过程，微观结构以及材料性能相关的基本原理，揭示材料孔隙结构对弹性模量影响的规律性关系；最后通过对具有不同孔隙度Ti-Nb基生物材料和生物组织的界面反应及内生速度来探索其相互作用规律，为股骨颈骨折治疗提供新的适宜的材料，具有重要潜在的应用价值。

本项目针对股骨颈骨折是一种常发性重要骨组织疾病的现实，设计和研究了一种组织具有内生性高孔隙金属Ti-Nb基植入型生物医用材料，成功的完成了材料元素设计、孔隙结构设计、材料制备研究、材料性能测试、材料微观结构分析，材料体外生物学性能评价、材料体内生物学特性研究等比较系统和深入的研究，取得了预期的研究结果，完成了预定的主要内容研究，比较好的达到了预定的研究目标。项目基于Ti-Nb基合金具有优良的生物相容性，力学性能和不含毒性元素的特点，采用模板浸渍法和粉末冶金法相结合研究制备孔隙度达40-70%、具有引导骨组织内生的孔隙结构（孔径300-600μm）、弹性模量与人体股骨适配以及不含毒性元素的多孔Ti-Nb基生物材料。研究了微观结构以及材料性能相关的基本原理，揭示材料孔隙结构对弹性模量影响的规律性关系；最后通过对具有不同孔隙度Ti-Nb基生物材料和生物组织的界面反应及内生速度来探索其相互作用规律，为股骨颈骨折治疗提供新的适宜的材料，具有重要潜在的应用价值。项目在多孔Ti-Nb基生物材料新技术、利用孔隙结构调节材料弹性模量、材料和组织界面间相互作用以及合金元素铌的添加改善力学性能等方面具有较强的创新意义。通过本项目实施，培养研究生4人，发表较高水平国外期刊的研究性论文9篇，其中SCI论文9篇。