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金属学报  2017, Vol. 53 Issue (3): 257-297    DOI: 10.11900/0412.1961.2016.00529
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处在变革中的医用金属材料
郑玉峰1,2(),吴远浩2
1 北京大学工学院材料科学与工程系 北京100871
2 北京大学前沿交叉学科研究院生物医用材料与组织工程中心 北京100871
Revolutionizing Metallic Biomaterials
Yufeng ZHENG1,2(),Yuanhao WU2
1 Department of Materials Science and Engineering, College of Engineering, Peking University, Beijing 100871, China
2 Center for Biomedical Materials and Tissue Engineering, Academy for Advanced Interdisciplinary Studies, Peking University, Beijing 100871, China
引用本文:

郑玉峰,吴远浩. 处在变革中的医用金属材料[J]. 金属学报, 2017, 53(3): 257-297.
Yufeng ZHENG, Yuanhao WU. Revolutionizing Metallic Biomaterials[J]. Acta Metall Sin, 2017, 53(3): 257-297.

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摘要: 

进入21世纪,医用金属材料正在发生变革。以可降解金属、纳米晶金属、大块非晶合金为代表的新型医用金属材料被尝试作为植入材料,材料属性正在从生物惰性向生物活性和生物功能化(抗菌、抗增生、抗肿瘤)方向发展,同时3D打印技术和薄膜技术也在被尝试用于金属植入器械的先进制造以及智能化。本文综合评述了处于变革中的医用金属材料研究现状,展望了新型医用金属材料功能化、复合化、智能化的未来发展趋势。

关键词 医用金属材料可降解金属大块非晶合金纳米晶金属3D打印功能化复合化智能化    
Abstract

Entering 21st century, the metallic biomaterials are revolutionizing. New kinds of metallic biomaterials represented by biodegradable metals, nacocrystalline metals and alloys, and bulk metallic glasses, had been explored as implantable biomaterials, and correspondingly the nature of metallic biomaterials are shifting from the bio-inert (with stainless steel, Co-based alloys and Ti alloys) to bio-active and multi-biofunctional (anti-bacterial, anti-proliferation, anti-cancer, etc.). The newly-emerging 3D printing technology and thin film technology had been applied to the advancing manufacture and intelligence of the medical devices made of metallic biomaterials. In this paper, the current research status of the revolutionizing metallic biomaterials had been reviewed, and the future research and development tendencies for newly-developed metallic biomaterials towards bio-functionalization, composite and intelligence are also proposed.

Key wordsmetallic biomaterial    biodegradable metal    bulk metallic glass    nanocrystalline metal    3D printing    biofunctionalization    composite    intelligence
收稿日期: 2016-11-22     
基金资助:国家重点发展研究计划项目Nos.2016YFC1102402和2016YFC1000903,国家自然科学基金重点项目No.51431002及NSFC/RGC合作研究计划项目Nos.51361165101和5161101031
图1  Mg及其合金降解示意图[2]
图2  镁合金设计中合金元素选择原则[12]
Alloy Cell viability of various cell lines
L929 NIH3T3 MC3T3-E1 ECV304 VSMC MG63 HUVACs SaOS2
As-cast Mg[47] 65 89 88 76 92
As-cast Mg-1Al[47] 98 118 110 87 105
As-cast Mg-1Ag[47] 77 90 94 88 99
As-cast Mg-1In[47] 95 100 91 82 80
As-cast Mg-1Mn[47] 70 62 62 63 71
As-cast Mg-1Si[47] 88 102 119 80 92
As-cast Mg-1Sn[47] 94 109 118 88 106
As-cast Mg-1Y[47] 91 98 101 68 88
As-cast Mg-1Zn[47] 110 111 111 100 109
As-cast Mg-1Zr[47] 80 81 101 72 89
As-extruded Mg-1Ca[20] 160
RS45Mg-3Ca[61] 105
As-cast Mg-1Ca-0.5Sr[62] 98
As-extruded Mg-6Zn[26] 99
As-cast Mg-5.45Zn-0.45Zr[63] 54 76
As-extruded Mg-5.45Zn-0.45Zr[63] 60 78
As-rolled Mg-1Sr[37] 84
As-rolled Mg-2Sr[37] 80
As-rolled Mg-3Sr[37] 69
As-rolled Mg-4Sr[37] 51
As-cast Mg-0.5Sr[38] 111
As-cast Mg-5Zr[64] 112
As-cast Mg-1Zr-1Sr[64] 104
As-cast Mg-2Zr-5Sr[64] 83
As-cast Mg-1.38Si-0.5Sr-0.6Ca[65] 100*
As-cast Mg-1.38Si-1Sr-0.6Ca[65] 94.6*
As-cast Mg-1.38Si-1Sr-1Ca[65] 81.2*
表1  新型医用镁合金的细胞相容性研究结果汇总[20,26,37,38,47,61~65]
Material
Shape
/ mm
Implant site
Implant
duration
/ week
New bone
formation
(Yes/No)
Degradation rate/
remaining volume
As-cast AD91D[66] ?1.5×20.0 Pig femur 18 Yes 3.516×10-4 mma-1
As-cast LAE442[66] ?1.5×20.0 Pig femur 18 Yes 1.205×10-4 mma-1
PCL coated AZ91[67] ?3×6 Rabbit trochanter 8 Yes 99.95% volume
As-cast AZ91[67] ?3×6 Rabbit 8 Yes 99.67% volume
As-rolled Mg-2Sr[37] ?0.7×5 Mice femur 4 Yes 1.01 mma-1
MgF2 coated LAE442[68] ?3×8 Rabbit femur 12 Yes 0.13 mma-1
Extruded LAE442[68] ?3×8 Rabbit femur 12 Yes 0.31 mma-1
Extruded+MgF2
coated Mg0.8Ca[69]
?2.5×25 Rabbit marrow cavity 24 Yes 74.67%
91.23% in musle
Extruded Mg-0.8Ca[18] Screw Rabbit lateral cortex 8 Yes 98.63% incortex
91.18% in marrow cavity
Extruded Mg-1Ca[20] Screw Rabbit femur shaft 12 Yes 1.27 mma-1
Extruded Mg-6Zn[26] ?4.5×10 Rabbit femur 14 Yes 2.32 mma-1
As-extruded Mg-1.2Mn-1.0Zn[70] ?4×1.5 Rat femur 18 Yes 46%
As-extruded+Ca-P coating
Mg-1.2Mn-1.0Zn[71]
?2.8×10 Rabbit femur 4 Yes -
As-cast Mg-2Zn-0.2Ca ?3.5×9 Rabbit femur 50 Yes 2.15 mma-1
As-cast+MAO coated
Mg-2Zn-0.2Ca[72]
?3.5×9 Rabbit femur 50 Yes 1.24 mma-1
As-cast Mg-5Zr[64] ?2.4×5 Rabbit femur 12 Yes -
As-cast Mg-1Zr-2Sr[64] ?2.4×5 Rabbit femur 12 Yes -
As-cast Mg-2Zr-5Sr[64] ?2.4×5 Rabbit femur 12 Yes -
As-cast Mg-Y-Nd-HRE[73] ?1.6×7 Rat femur 24 Yes -
Rapidly solidified Mg-5Bi-1Ca[74] ?3×5 Rabbit femur 4 Yes 1.85 mma-1
表2  新型医用镁合金植入动物体内之后的生物相容性以及降解性能汇总[18,20,26,37,64,66~74]
Material Coating Corrosion rate in vitro Biocompatibility
mma-1 mLcm-2d-1
As-cast Mg[104] Alkali-heat treatment No inhibitory effects on marrow cells growth. No signs of cellular lysis
As-cast Mg[105] Beta-TCP coating MG63 viability about 80%
As-cast Mg[106] Heat-self-assembled monolayer No inhibitory effects on marrow cells growth; hemolysis is 0
As-extruded Mg-0.8Ca[14] MgF2 coating After 10 d smooth muscle and endothelial cells around the alloys were still alive
As-cast Mg-1Ca[87] Na2HPO4 alkaliheat treatment 2.08a 0.7a No obvious toxicity to L929 cells
As-cast Mg-1Ca[87] Na2CO3 alkali-heat treatment 2.27a 0.86a No obvious toxicity to L929 cells
As-cast Mg-1Ca[87] NaHCO3 alkali-heat treatment 2.29a 0.48a No obvious toxicity to L929 cells
As-cast Mg-1Ca[107] Electrodeposition 0.17b
As-extruded Mg-1Ca[108] Electrodeposition 0.14b
As-extruded Mg-1Ca[98] Chitosan coating 0.312~0.686a
As-extruded Mg-6Zn[91,109] Electrodeposition (1.9×10-3)c About 0.07a
As-extruded Mg-6Zn[91,109] HA electrodeposition About 0.06a
As-extruded Mg-6Zn[91,109]
FHA electrodeposition
About 0.02a
Present more stimulation effects to hBMSCs proliferation and differentiation; can up-regulate main osteogenic genes after 21 d of culture
As-extruded Mg-6Zn[101] PLGA coating 0.68~1.18a Significantly enhanced ability of MC3T3 cell attachment
As-extruded Mg-Mn-Zn[110] DCPD 0.09~0.30c Better surface cytocompatibility than naked
Mg-Mn-Zn alloy and pure Ti
As-cast Mg-Zn-Ca[93] Ca-deficient HA coating 0.56a
As-cast AZ31[111] Ca-P coating Hemolysis is 2.5%
As-cast AZ31[112] CeO2/MgO coating 0.03c Good anti-clotting property equivalent to that of 316L stainless steel
As-cast AZ31[113] MgO anodic oxidation Does not affect the proliferation and the bone formation of osteoblast; hemolysisis 4.3%
As-extruded AZ31[108] DCPD 0.06b
As-extruded AZ31[114] MgF2 2.26b 0.0011b
As-cast AZ91[90,114~116] MAO coating (7.1×10-4~3.4×10-3)a
As-cast AZ91[117] Laser surface melting 0.17a
As-cast AZ91[118] Hydrogenated amorphous silicon 0.08a hFOB1.19 cells attach well on the coating and proliferate normally
As-extruded WE43[119] Chitosan coating 0.05b
As-extruded LAE442[68] MgF2 coating 0.77b
表3  表面改性方法对镁合金腐蚀降解性能以及生物相容性的影响[14,68,87,90,91,93,98,101,104~119]
图3  不同表面改性方法对镁合金腐蚀速率的影响[2]
图4  纯Zn丝在SD大鼠体内降解速率[120]
Alloy Yield strength
MPa
Ultimate strength
MPa
Elongation
%
As-cast Zn[122] 20 0.3
As-rolled Zn[124] 20.99 49.55 5.72
As-cast Zn-1Mg[122] 108 153 1.5
As-cast Zn-1.5Mg[122] 147 0.4
As-cast Zn-3Mg[122] 28 0.2
As-rolled Zn-1Mg[124] 190.61 236.9 11.95
As-rolled Zn-1Ca[124] 205.52 253.3 12.76
As-rolled Mg-1Sr[124] 188.42 228.91 19.69
As-rolled Zn-1Mg-0.1Mn[125] 195.02 299.04 26.07
As-cast Zn-1Mg-1Ca*[126] 80 130 1
As-cast Zn-1Mg-1Sr*[126] 88 138 1.2
As-cast Zn-1Ca-1Sr*[126] 87 140 1.1
As-rolled Zn-1Mg-1Ca*[126] 138 198 8.8
As-rolled Zn-1Mg-1Sr*[126] 140 201 9.9
As-rolled Zn-1Ca-1Sr*[126] 145 205 9
As-extruded Zn-1Mg-1Ca*[126] 205 258 5.4
As-extruded Zn-1Mg-1Sr*[126] 203 256 7.5
As-extruded Zn-1Ca-1Sr*[126] 212 250 6.8
表4  纯Zn及锌合金力学性能[122,124~126]
Alloy
Yield
strength
MPa
Ultimate
strength
MPa
Elongation
%
Magnetic susceptibility μm3kg-1 Corrosion rate
mma-1
As-cast pure iron[128] - - - - 0.008
Annealed pure iron[128] 140±10 205±6 25.5±3 - 0.16±0.04
Electroformed pure iron[128] 360±9 423±12 8.3±2 - 0.85±0.05
ECAP pure iron[129] - 470±29 - - 0.02
PM pure iron[130] - - - - 5.02
SPS pure iron[131] - - - - 0.016
FeN[131] 561.4 614.4 - - 0.225
Fe-10Mn (forged)[132] 650 1300 14 - 7.17
Fe-10Mn-1Pd (forged)[133] 850 1450 11 - 25.10
Fe-30Mn (as-cast)[134] 124.5 366.7 55.7 - 0.12
Fe-30Mn-6Si (as-cast)[134] 177.8 433.3 16.6 - 0.29
Fe-30Mn (forged)[135] 169 569 60 0.16 0.12
Fe-30Mn-1C (forged)[135] 373 1010 88 0.03 0.2
Fe-3Co (as-rolled)[136] 460 648 5.5 - 0.142
Fe-3W (as-rolled)[136] 465 712 6.2 - 0.148
Fe-3C (as-rolled)[136] 440 600 7.4 - 0.187
Fe-3S (as-rolled)[136] 440 810 8.3 - 0.145
Fe-20Mn (PM)[137] 420 700 8 0.2 -
Fe-25Mn (PM)[137] 360 720 5 0.2 0.52
Fe-30Mn (PM)[137] 240 520 20 0.2 -
Fe-35Mn (PM)[137] 230 430 30 0.2 0.44
Fe-0.06P (PM)[130] - - - - 7.75
Fe-0.05B (PM)[130] - - - - 7.17
Fe-5W (SPS)[130] - - - - 0.138
Fe-1CNT (SPS)[130] - - - - 0.117
Fe-5Pd (SPS)[138] - - - - 0.0724
Fe-5Pt (SPS)[138] - - - - 0.0983
316L SS[127] 190 490 40 0.5 -
WE43[127] 150 250 4 - -
表5  可降解血管支架用各种金属材料与316L不锈钢的典型力学性能比较[127~138]
图5  纯Fe在模拟体液(SBF)中浸泡过程中的失重量和腐蚀速率[142]
Material Animal model and implantation period / week Testing method Result
Pure iron stent[141]
Rabbit (descending arteries), 24~72 Quantitative arteriography+morphological analysis+pathological analysis No thrombosis or endothelial hyperplasia
Pure iron stent[144] Pig (descending arteries), 52 Quantitative arteriography+histological analysis No toxicity. Endothelial hyperplasia was similar to that of 316L SS stents
Pure iron[145] Pig (coronary arteries), 4
Histological analysis
Safe enough with less endothelial hyperplasia
Pure iron stent[148]
Pig (left anterior descending arteries and coronary arteries), 4 Pathological analysis+OCT
No inflammation and thrombosis, no iron overload and abnormal
pathological change
Pure iron wire[146] Mice (artery lumen and artery wall), 3~36 Histological analysis
optimal microscope+X-ray
Corrosion products remained in the vessel walls after 9 months
Pure iron foil roll[147] Mice (tails), 4~36 Histological and genetic expression analysis Degradation products aggregated, slight inflammation and no toxicity
Nitriding iron stent[132]
Pig (left and right iliac arteries), 12~48 Quantitative arteriography+histological analysis Endothelial procedure completed
in 1 month, but restenosis happened
after 12 months
Pure iron, Fe-10Mn-1Pd, Fe-21Mn-0.7C-1Pd
alloy bone pin[149]
Mice (bone), 4, 12, 24, 52
μCT+histological analysis
No significant difference between pure iron and iron alloys
表6  纯Fe及其合金作为血管支架的在体研究[132,141,144~149]
Alloy
Critical
size
mm
Compressive
strength
MPa
Young's
modulus
GPa
Specific
strength
kNmkg-1
Vickers
hardness
HV
Ti40Zr10Cu36Pd14[173] 6 1950 82 270
Ti75Zr10Si15[175] About 30 μm >2000 - - 790
Ti45Zr10Cu31Pd10Sn4[174] 15 2060 - 310
Ti45Zr10Cu31Pd10Sn4[176] 4 1970 95 650
Ti45Ni15Cu25Sn3Be7Zr5[171] 5 2480 715
Ti43.15Zr9.59Cu36.24Ni9.06Sn1.96[172] 3 2640 400
Ti41.5Zr2.5Hf5Cu37.5Ni7.5Si1Sn5[177] 6 2000±78 80±12 600
Ti41.5Zr2.5Hf5Cu42.5Ni7.5Si1[178] About 5 2080 103
Ti43.3Zr21.7Ni7.5Be27.5[179] 1790 95 351
Ti47Cu38Zr7.5Fe2.5Sn2Si1Ag2[180] 7 2080 100.4±0.1 588±6
表7  不同钛基非晶合金的力学性能汇总[171~180]
图6  几种典型锆基非晶合金的压缩应力应变曲线[185]
Alloy
Critical
size
mm
Ultimate
strength
MPa
Young's
modulus
GPa
Vickers
hardness
HV
Zr52.5Al10 Ti5Cu17.9 Ni14.6 (BAM-11)[187] 7 1700 90 590
Zr61Cu17.5Ni10Al7.5Si4[188] About 1800 510
Zr60Cu22.5Pd5Al7.5Nb5[189] 1720 82
Zr60Ti6Cu19Fe5Al10[185] 1652 70
Zr60Nb5Cu20Fe5Al10[185] 1795 72
Zr60Nb5Cu22.5Pd5Al7.5[190] 1724 70~85
Zr56Al16Co28[191,192] 18 1830 83
Zr65Pd17.5Fe10Al7.5[193] 6 About 1500 422
Zr60.14Cu22.31Fe4.85Al9.7Ag3[194] 10 1720±28 82±1.9
Zr46Cu37.6Ag8.4Al8[195] 2158 92 554
Zr51.9Cu23.3Ni10.5Al4.3[195] 1997 102 550
Zr62.5Al10Fe5Cu22.5[196] 6 1700 80 459
表8  不同锆基非晶合金的力学性能汇总[185,187~196]
图7  不同铁基非晶合金的压缩应力应变曲线[205]
Alloy Critical size
mm
Ultimate strength
MPa
Young's modulus
GPa
Vickers hardness
HV
Fe41Co7Cr15Mo14C15B6Y2[206,207] 16 3500 1253
Fe63Mo14C15B6Er2[208] 3 4000 204 1122
Fe55Cr8Mo14C15B6Er2[208] >4 209 1122
Fe48Cr15Mo14C15B6Er2[208] 12 4200 213 1133
Fe49Cr15Mo14C(13+x)B(8-x)Er1(x=2, 4, 5, 6)[209] 3~6 4040~4140 210~220
(Fe0.9Co0.1)58.5Cr6Mo14C(15+x)B(6-x)Er0.5(x=3, 4) [209] 2~4 4070~4100 200
Fe70B20Si10[185] About 2500 714
FexCryMoz[205]
(x=63~71, y=0~3, z=5~12)
2.5~3 3150~3550 176~183 845~974
表9  不同铁基非晶合金的力学性能[185,205~209]
BMG Alloy Critical
size / mm
Ultimate
strength / MPa
Young's modulus
GPa
Vickers hardness / HV
Ca-based





Ca(57.5-x)Mg(15+x)Zn27.5 (x=0, 2.5, 5)[213] 2.5~4.5 - 36~39 0.9~1.4
Ca52.5Mg17.5Zn30[213] 0.9 44 1.4
Ca52.5Mg22.5Zn25[213] 1.0 43 0.8
Ca50Mg20Zn30[213] 1.2 46 0.7
Ca65Li9.96Mg8.54Zn16.5[214] 5 530 23.4 1.35
Ca48Zn30Mg14Yb8[215] 2 600 31.9
Ca20Mg20Zn20Sr20Yb20[216] 4 370 19.4
Mg-based







Mg65Cu25Gd10[188] About 800 About 2.5
Mg60Cu29Y10Si1[217] 2.6 About 66 About 4
Mg(80-x)Ca5Zn(15+x) (x=5~20)[218] 1~4 700 47.6~48.2 2.16
Mg(96-x)ZnxCa4 (x=25, 30)[219] 2~5 830~930
Mg67Zn28Ca5[220] 0.1 817 2.16
Mg69Zn27Ca4[221] 1.5 About 550
Mg66Zn30(Ca4-x)Srx (x=0, 0.5, 1, 1.5)[222] 4~6 787~848 48.5~49.4 2.45~2.51
Mg66Zn(30-x)Ca4Agx (x=0, 1, 3)[222] 1~4 780 2.35
Zn-based Zn38Ca32Mg12Yb18[215] 2 About 640 About 36.6
Zn40Mg11Ca31Yb18[224] 2 663
Sr-based
Sr40Mg20Zn15Yb20Cu5[225] 3 408 20.6
Sr60Mg18Zn22[226] 3 19.7
Sr60Li5Mg15Zn20[226] 3 18.4
表10  不同可降解非晶合金的力学性能[188,213~226]
图8  电子束熔融方法制备的多孔钛合金材料[258]
Method Material Yield strength
MPa
Ultimate strength
MPa
Elongation
%
Reduction of area
%
EBM[260] Ti-6Al-4V ELI 834 920 16 54
EBM[260] Ti-6Al-4V 938~948 2016~2034 14.8~16.2 39~46
SLM[264] Ti-6Al-4V ELI 1110 1267 7.28
SLM[265] Ti-6Al-4V 990 1096 8.1
Forging[266] Ti-6Al-4V ELI 795 860 >10 >25
Forging[266] Ti -6Al-4V 860 930 >10 >25
表11  不同方法制备的钛合金力学性能总结[260,264~266]
Material
Processing
Hardness
HV
Young's
modulus
GPa
Yield strength
MPa
Ultimate strength
MPa
Elongation
%
CP-Ti[275] SLM 261±13 106±3 555 757 19.5
CP-Ti[277] SLM 500 650 17
CP-Ti[278] Sheet forming 280 345 20
CP-Ti[279] Full annealed 432 561 14.7
Ti-6Al-4V[264] SLM 409 109 1110 1267 7.28
Ti-6Al-4V[280,281]
Casting/superplastic forming 346
110
847
976
5.1
Ti-24Nb-4Zr-8Sn[274] SLM 220±6 53±1 563±38 665±18 13.8±4.1
Ti-24Nb-4Zr-8Sn[282] Hot rolling 46 700 830 15
Ti-24Nb-4Zr-Sn[283] Hot forging 55 570 755 13
表12  激光选区熔化(SLM)技术与传统方法制备的钛合金力学性能和硬度对比[264,274,275,277~283]
Material Yield strength
MPa
Ultimate strength
MPa
Elongation% Reduction of area%
Ti-5Al-5Mo-5V-1Cr-1Fe[292] 1178±20 5±0.5 9.8±1.7
Ti-6.5Al-3.5Mo-1.5Zr-0.3Si(vertical to the deposition direction)[297] 920 1025 8.2 17
Ti-6.5Al-3.5Mo-1.5Zr-0.3Si(along the deposition direction)[297] 840 925 18.8 26
表13  激光熔融沉积(LDMD)制备的钛合金的力学性能[292,297]
图9  各种新型医用金属材料的力学性能总结[13,20,24~29,37,41,49,62,64,170~176,181~191,195,196,206~209,212~221,214~216]
图10  集成有诊断、治疗功能的新型血管支架[335]
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