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金属学报  2017, Vol. 53 Issue (10): 1238-1264    DOI: 10.11900/0412.1961.2017.00288
  研究论文 本期目录 | 过刊浏览 |
新型医用钛合金材料的研发和应用现状
于振涛1,2(), 余森1,2, 程军1,2, 麻西群1,2
1 西北有色金属研究院 西安 710016
2 西北有色金属研究院陕西省医用金属材料重点实验室 西安 710016
Development and Application of Novel Biomedical Titanium Alloy Materials
Zhentao YU1,2(), Sen YU1,2, Jun CHENG1,2, Xiqun MA1,2
1 Northwest Institute for Non-Ferrous Metal Research, Xi'an 710016, China
2 Shaanxi Key Laboratory of Biomedical Metal Materials, Northwest Institute for Non-Ferrous Metal Research, Xi'an 710016, China
引用本文:

于振涛, 余森, 程军, 麻西群. 新型医用钛合金材料的研发和应用现状[J]. 金属学报, 2017, 53(10): 1238-1264.
Zhentao YU, Sen YU, Jun CHENG, Xiqun MA. Development and Application of Novel Biomedical Titanium Alloy Materials[J]. Acta Metall Sin, 2017, 53(10): 1238-1264.

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摘要: 

医用钛合金材料已成为骨科、齿科和心血管等植介入物或器械用主要原材料,但要满足患者临床治疗的长效安全性和功能性,医用钛合金材料的生物及力学相容性仍有待提高。无论是开发新型高强度、低模量等综合性能优良的新型医用钛合金材料,还是立足对传统医用钛合金材料性能的优化升级,确保医用钛合金材料的均质化、高性能、多功能和低成本是扩大其临床应用的基础和关键。本文从医用钛合金材料合金设计、物理冶金、材料加工、组织与性能、表面改性、先进制造及临床应用等诸方面进行综述,并介绍了作者研发团队的最新进展,展望了未来发展趋势及待解决的问题。
关键词 ： 医用钛合金,  外科植入物,  生物及力学相容性,  合金设计,  物理冶金,  超细晶材料,  多孔材料,  表面改性    
Abstract：

Biomedical titanium alloy materials have become the main raw materials for orthopedic, dental and cardiovascular implants or devices, but their biological and mechanical compatibility remains to be improved to meet the long-term safety and function in services for clinical application. Whether developing the novel medical titanium alloys with high-strength, low-modulus and other finer comprehensive performance, or upgrading and optimizing the traditional medical titanium alloys, it is the foundation and key to ensuring the structure homogeneity, high performance, versatility and low cost of biomedical titanium alloy materials and expanding its clinical application. The design, physical metallurgy, materials process, microstructure and properties, surface modification, advanced manufacturing and the clinical application of biomedical titanium alloys were introduced, and their latest research progress was reviewed in this paper, together with the recent advances in the author's R & D team. Finally, the further research and development trend of biomedical titanium alloys are summarized.
Key words： biomedical titanium alloy    surgical implant    biological and mechanical compatibility    alloy design    physical metallurgy    ultrafine-grained material    porous material    surface modification
收稿日期: 2017-07-12     
ZTFLH:  TG146.2  
基金资助:国家自然科学基金项目No.31400821,国家重点研发计划项目No.2016YFC1102003,陕西省重点科技创新团队项目No.2016KCT-30和陕西省科技成果转化专项项目No.2016KTCG01-04
作者简介:

作者简介 于振涛,男,1964年生,教授级高级工程师,博士
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https://www.ams.org.cn/CN/10.11900/0412.1961.2017.00288      或      https://www.ams.org.cn/CN/Y2017/V53/I10/1238

Alloy Yield strength Ultimate strength Elongation Reduction Elastic
MPa MPa % of area modulus
% GPa
Pure Ti (grade 1~4) 170~485 240~550 15~24 25~30 about 103
Ti-6Al-4V (annealed) 820~870 900~930 6~10 20~25 110~114
Ti-6Al-7Nb 880~950 900~1050 8~15 25~45 114
Ti-5Al-2.5Fe 895 1020 15 35 112
Ti-13Nb-13Zr (aged) 830~910 970~1040 10~16 27~53 79~84
Ti-12Mo-6Zr-2Fe 1000~1060 1060~1100 18~22 64~73 74~85
(TMZF) (annealed)
Ti-15Mo (annealed) 544 874 21 82 78
Ti-15Mo-5Zr-3Al 838 852 25 48 80
(solution treatment)
Ti-15Mo-2.8Nb-0.2Si 945~987 979~999 16~18 60 83
(annealed)
Ti-35Nb-5Ta-7Zr 547 596 19 68 55
Ti-29Nb-13Ta-4.6Zr 860 910 13 80
Ti-24Nb-4Zr-7.9Sn 800~1100 850~1150 15 42~72
(Ti2448) (aged)
TAMZ/Ti-75 (Ti-2Al-2Mo-2Zr) ≥700 ≥750 ≥12% 105
TLE (Ti-5Zr-5Mo-15Nb) 310~365 620~760 21~39 74~83 58~73
(solution treatment)
TLE (Ti-5Zr-5Mo-15Nb) (aged) 560~1020 700~1060 15~22 67~77 58~84
TLM (Ti-3Zr-2Sn-3Mo-25Nb) 275~500 660~705 21~26 75~84 53~60
(solution treatment)
TLM (Ti-3Zr-2Sn-3Mo-25Nb) (aged) 610~950 685~1050 17~23 70~71 45~81
Ti-B12 (Ti-10Mo-6Zr-4Sn-3Nb) 830~940 930~1040 14~20 66~77 53~80
(solution treatment)
Ti-B12 (Ti-10Mo-6Zr-4Sn-3Nb) 960~1130 1000~1210 9~15 33~46 81~95
(aged)
表1  部分典型的新型医用钛合金材料的力学性能
Project name EBCHM PCHM VAR NC CCM ESR
Material status Bulk, bar Bulk, bar Consumable Bulk Bulk Bar electrode
electrode
Ingot size Large, midsize, Large, midsize, Large, Midsize, small Midsize, small Midsize, small
small small midsize, small
End face shape of ingot Circular and Circular and Circular Circular and Circular and Circular and
dysmorphism dysmorphism dysmorphism dysmorphism dysmorphism
Deaeration effect Optimum Limited Limited Limited Limited Limited
Vacuum / Pa 0.1~0.133 Inactive gas 0.013~6.65 Inactive gas Inactive gas Inactive gas
0.133~101325 2660~3990 33250~50540
Composition control Burning Fine Easy to General Easy Unmanageable
ingredient, control, good
unmanageable
Surface quality Good Good General General General Better
Melting rate / (kgh?1) 500~1800 600~900 800~2000 300~800 400 -
Foundry returns using Larger Larger Limited Larger Limited Limited
Specific electric energy Larger Larger Smaller Larger Bigger Bigger
consume
Manipulation difficulty Hard Common Easy Common Common Common
Equipment investment Highest Higher Low Lower Common Common
表2  几种真空熔炼方法的对比
图1  TNTZ (Ti-29Nb-13Ta-4.6Zr)钛合金
图2  Ti-3.5Cu合金宏观形貌和显微组织
Nominal composition Zr Fe Si C N H O Ti
Ti-1Zr 0.98 0.01 <0.04 0.021 0.007 0.0009 0.078 Bal.
Ti-2Zr 1.98 0.01 <0.04 0.019 0.014 0.0010 0.082 Bal.
Ti-16Zr 16.30 0.02 <0.04 0.015 0.013 0.0010 0.090 Bal.
Ti-20Zr 20.90 0.01 <0.04 0.014 0.014 0.0010 0.084 Bal.
Ti-35Zr 35.71 0.03 <0.01 0.008 0.003 0.0010 0.086 Bal.
Ti-50Zr 48.52 0.05 <0.01 0.010 0.015 0.0010 0.081 Bal.
Ti-60Zr 58.40 0.02 <0.04 0.008 0.009 0.0037 0.088 Bal.
表3  Ti-Zr系钛合金的化学成分
图3  Ti-Nb系钛合金棒材的微观组织
Condition Yield strength Ultimate strength Elongation Elastic modulus Yielding-to-tensile
MPa MPa % GPa ratio
1 layer (cold rolled) 445 805 1.5 59.6 0.5528
2 layers 445 990 3.5 65.0 0.4495
4 layers 800 1120 4.5 63.7 0.7143
8 layers 955 1200 5.0 67.4 0.7958
表4  超细晶TLM钛合金箔材的力学性能
图4  多孔TLM钛合金宏观与微观形貌及孔隙率与弹性模量曲线图
图5  TLM钛合金经固溶时效后的相组成及室温力学性能
Biological evaluation National/international standard
Material chemical characterization GB/T16886.18-2011/ISO10993-18: 2005
Sample preparation and reference materials GB/T16886.12/ISO10993-12: 2007
Test for in-vitro cytotoxicity GB/T16886.5/ISO10993-5: 2009
Test for irritation and skin sensitization GB/T16886.10/ISO10993-10: 2010
Test for systemic toxicity GB/T16886.11-2011/ISO10993-11: 2006
Test for genotoxicity, carcinogenicity and reproductive toxicity GB/T16886.3-2008/ISO10993-3: 2003
Test for partial biological effects of implants GB/T16886.6/ISO10993-6: 2007
Selection of tests for interactions with blood GB/T16886.4-2003/ISO10993-4: 2002
Qualitative and quantitative analyses for degradation products of metal and alloy GB/T16886.15-2003/ISO10993-15: 2000
Toxicokinetic study design for degradation products and leachables GB/T16886.16/ISO10993-16: 2010
Principles and methods for immunotoxicology testing of medical devices GB/T16886.20/ISO/TS10993-20: 2006
Biological evaluation for dental medical devices YY/T0268/ISO7405, YY/T0127, YY/T0244
表5  医用钛合金器械的生物学评价相关标准[112]
图6  表面去合金化后TLM钛合金表面形貌
图7  激光选区熔化法制备出类骨小梁组织的多孔TLM钛合金植入物材料
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