Development of high biocompatible titanium alloys for medical and welfare applications

开发用于医疗和福利应用的高生物相容性钛合金

• 批准号: 10555231
• 负责人: NIINOMI Mitsuo
• 金额: $ 7.94万
• 依托单位: Toyohashi University of Technology
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (B).
• 财政年份: 1998
• 资助国家: 日本
• 起止时间: 1998 至 2000
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-10555231/
• 关键词: Biomedical titanium alloy; Ti-29Nb-13Ta-4.6Zr alloy; Low Young's modulus; Biocompatibility; Cyto-toxicity; Mechanical properties; Fatigue characteristics; Friction wear characteristics; 高生体適合性; 生体用材料; β型チタン合金; 医療・福祉; 加工熱処理; ミクロ組織; 力学的生体融合性 /

According to the data on cytotoxicity of pure metals and representative metallic biomaterials, non-toxic elements Nb, Ta, Zr, Mo and Sn were selected as alloying elements for designing new β type titanium alloys for biomedical applications with low Young's modulus, high strength and high workability. Ti-29Nb-13Ta, Ti-29Nb-13Ta-4.6Zr, Ti-16Nb-13Ta-4Mo, Ti-29Nb-13Ta-4Mo, Ti-29Nb-13Ta-2Sn, Ti-29Nb-13Ta-4.6Sn and Ti-29Nb-12Ta-6Sn were designed using d-electron alloy design method. Small ingots of designed alloys with a weight of 45g were fabricated followed by thermomechanical treatments in the laboratory, and plastic workability and basic mechanical properties of the alloys were then evaluated. Every alloy could be expected to full fill the target performance for biomedical applications, but Ti-29Nb- 13Ta-4.6Zr was found to easily satisfy the balance of strength, elongation and Young's modulus. Furthermore, judging from the data on the cytotoxicity of alloying elements, Ti-29Nb-13Ta-4.6Zr … More was expected to be excellent in biocompatibility. Then, the cytotoxicity of Ti-29Nb-13Ta-4.6Zr was evaluated using L 929 cells. Cytotoxicity of this alloy was similar to that of pure titanium.Therefore, the further evaluation for practical use was determined to be carried out on Ti-29Nb-13Ta-4.6Zr. For the first step, practical level ingot was fabricated. The homogeneous practical level ingot was successfully fabricated by induction melting method or levitation melting method. Thermomechanical treatments were carried on the practical level ingot, and then mechanical properties of the thermomechanical treated ingot were evaluated. Solution treatment followed by aging, or direct aging after cold rolling gave Ti-29Nb-13Ta-4.6Zr qeuivalent balance of strength and ductility to that of Ti-6Al-4V ELI with keeping low modulus. Then, wear characteristics of Ti-29Nb-13Ta-4.6Zr were evaluated in simulated body environment. The wear resistance of Ti-29Nb-13Ta-4.6Zr was greater than that of Ti-6Al-4V ELI or SUS 316 L stainless steel when zirconia was used as a mating material, but opposite trend was observed when alumina was used as a mating material. Therefore, it was concluded that the surface treatment was necessary to improve the wear resistance of Ti-29Nb-13Ta-4.6Zr. Oxidation treatment was found to be effective to improve the wear resistance of Ti-29Nb-13Ta-4.6Zr. The fatigue strength of Ti-29Nb-13ta-4.6Zr was improved very much by conducting solutionizing and aging, and was equal to that of Ti-6Al-4V ELI.The fatigue ratio of Ti-29Nb-13Ta-4.6Zr was greater than that of conventional β type titanium alloy, and was equivalent to that of conventional α+ β type biomedical titanium alloys. Fretting fatigue strength of Ti-29Nb-13Ta-4.6Zr was significantly smaller than that of plain fatigue strength, but *quivalent to that of conventional biomedical titanium alloys. The decrease in fatigue strength due to fretting was relatively smaller in Ti-29Nb-13Ta-4.6Zr.Phosphate calcium crystallized glass could be easily formed on Ti-29Nb-13Ta-4.6Zr in air comparing with the case of pure titanium or Ti-6Al-4V.Biocompatibility of Ti-29Nb-13Ta-4.6Zr was significantly improved by this surface coating of phosphate calcium, crystallized glass.Ti-29Nb-13Ta-4.6Zr, Ti-6Al-4V and SUS 316L stainless steel were implanted in the muscle near the spine of the rabbit, and then the muscle tissue change was examined. Each muscle tissue was nearly the same. Therefore, the biocompatibility of Ti-29Nb-13Ta-4.6Zr was found to be excellent.From the results mentioned above, Ti-29Nb-13Ta-4.6Zr is strongly expected to be put into practical use. In order to put Ti-29Nb-13Ta-4.6Zr into practical use, further development in mechanical properties by microstructural control, establishment of surface treatment to improve the wear resistance, further evaluation of fatigue strength and fretting fatigue strength in simulated body environment, verifying the effectiveness of low modulus using living body, and biocompatibility test using bigger animals are needed. Furthermore clinical tests of the alloy is needed. Ti-29Nb-132Ta-4.6Zr is also expected to be applied for dental products. Therefore, the practical use of Ti-29Nb-13Ta-4.6Zr is highly expected in dental field. Less

根据有关纯金属细胞毒性的数据，代表金属生物材料，无毒元素NB，TA，ZR，MO和SN被选为用于设计新型β型钛合金的合金元素，用于具有低杨氏模量，高强度和高的可工作能力。 TI-29NB-13TA，TI-29NB-13TA-4.6ZR，TI-16NB-13TA-4MO，TI-29NB-13TA-2SN，TI-29NB-13TA-4.6SN和TI-29NB-129NB-12TA-6SN使用D-Electron Alloy Design Design Design Modect设计。制造具有45G重量的设计合金的小姜汁，然后在实验室中进行热机械处理，然后评估合金的塑性可加工性和基本机械性能。可以期望每种合金充分填充生物医学应用的目标性能，但是发现TI-29NB-13TA-4.6ZR可以轻松满足强度，伸长率和Young的模量的平衡。此外，从关于合金元件的细胞毒性的数据来​​看，TI-29NB-13TA-4.6ZR…预计会在生物相容性方面具有出色的优势。然后，使用L 929细胞评估TI-29NB-13TA-4.6ZR的细胞毒性。该合金的细胞毒性与纯钛相似。因此，确定在TI-29NB-13TA-4.6ZR上确定实际使用的进一步评估。在第一步中，制造了实用的水平铸币。均质实用水平的铸币套件是通过感应熔化方法或悬浮熔化方法成功制造的。在实用水平的铸锭上进行了热机械处理，然后评估了经过热机械处理的铸锭的机械性能。溶液处理，然后在冷滚后进行衰老或直接衰老，可以使TI-29NB-13TA-4.6ZR QEUUIVIC平衡强度和耐ti-6al-4V Eli的强度和延展性，并保持低模量。然后，在模拟的身体环境中评估了TI-29NB-13TA-4.6ZR的磨损特性。当使用氧化锆用作交配材料时，TI-29NB-13TA-4.6ZR的耐磨性大于TI-6AL-4V ELI或SUS 316 L不锈钢的耐磨性，但是当使用氧化铝用作交配材料时，观察到了相反的趋势。因此，得出的结论是，必须进行表面处理以提高TI-29NB-13TA-4.6ZR的耐磨损性。发现氧化处理可有效提高TI-29NB-13TA-4.6ZR的耐磨性。 TI-29NB-13TA-4.6ZR的疲劳强度通过进行解决和衰老而得到了很大的改善，并且是ELI。TI-29NB-13TA-4.6ZR的疲劳比大于常规β型钛合金的疲劳比，并且与常规的β型钛合金合金相当于常规β+β型型titan titan titan titan titan titan titan titan titan。 TI-29NB-13TA-4.6ZR的疲劳强度明显小于普通疲劳强度的疲劳强度，但 *与常规生物医学钛合金的疲劳强度相当。在TI-29NB-13TA-4.6ZR.磷酸钙中，疲劳强度的降低相对较小，磷酸钙结晶玻璃可以很容易地在TI-29NB-13TA-4.6ZR上形成空气中的空气中，与纯钛或Ti-6al-4v.biipational of Ther-4v.biybiational of The Ti-29n-B-13t的案例相比，可以在空气中形成。磷酸钙，结晶的玻璃。TI-29NB-13TA-4.6ZR，TI-6AL-4V和SUS 316L不锈钢植入了兔子脊柱附近的肌肉，然后检查了肌肉组织的变化。每个肌肉组织几乎相同。因此，发现TI-29NB-13TA-4.6ZR的生物相容性非常出色。从上述结果中，TI-29NB-13TA-4.6ZR强烈期望将其投入实际使用中。为了使TI-29NB-13TA-4.6ZR用于实际使用，通过微观结构控制进一步发展机械性能，建立表面处理以提高耐磨性，进一步评估疲劳强度和模拟身体环境中疲劳强度的疲劳强度，验证使用较大的身体和生物能力测试的低模量的有效性，以及使用较大的动物。此外，需要合金的临床测试。 TI-29NB-132TA-4.6ZR也有望用于牙科产品。因此，在牙科领域高度期望TI-29NB-13TA-4.6ZR的实际使用。较少的

项目成果

D.Kuroda et al.: "Design and Mechanical Properties of New β Type Titanium Alloys for Implant Materials" Materials Science and Engineering. A243. 244-249 (1998)

D.Kuroda 等人：“用于植入材料的新型 β 型钛合金的设计和机械性能”材料科学与工程 244-249 (1998)。

M.Niinomi: "Development of Titanium Alloys Composed of Non-toxic Elements with Low Modulus and High Strength for Biomedical Applications"Transaction of the Sixth World Biomaterials Congress. 1359 (2000)

M.Niinomi：“开发用于生物医学应用的由无毒元素组成的低模量和高强度钛合金”第六届世界生物材料大会的交易。

M.Niinomi: "Recent Research and Development of Tianium for Biomedical Applications in Japan"JOM. 51巻6号. 32-34 (1999)

M. Niinomi：“日本生物医学应用钛的最新研究和开发”JOM，第 51 卷，第 6 期。32-34 (1999)

M.Niinomi et al.: "Development of β Type Titanium Alloys for Hard Tissue Replacing Materials" Proc.SSAM-4. 365-368 (1998)

M. Niinomi 等人：“用于硬组织替代材料的 β 型钛合金的开发”Proc.SSAM-4 (1998)。

D.Kuroda: "Design and Mechanical Properties of New β Type Titanium Alloys for Implant Materials"Materials Science and Engineering. A243. 244-249 (1998)

D.Kuroda：“用于植入材料的新型β型钛合金的设计和机械性能”材料科学与工程244-249（1998）。