CN112274301B - 含氧化层锆铌合金踝关节假体系统及制备方法 - Google Patents
含氧化层锆铌合金踝关节假体系统及制备方法 Download PDFInfo
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- 229910001257 Nb alloy Inorganic materials 0.000 title claims abstract description 45
- GFUGMBIZUXZOAF-UHFFFAOYSA-N niobium zirconium Chemical compound [Zr].[Nb] GFUGMBIZUXZOAF-UHFFFAOYSA-N 0.000 title claims abstract description 40
- 210000000544 articulatio talocruralis Anatomy 0.000 title claims abstract description 24
- 238000002360 preparation method Methods 0.000 title claims abstract description 14
- 239000013067 intermediate product Substances 0.000 claims abstract description 71
- 238000001816 cooling Methods 0.000 claims abstract description 47
- 210000002303 tibia Anatomy 0.000 claims abstract description 42
- 210000000988 bone and bone Anatomy 0.000 claims abstract description 33
- 210000004233 talus Anatomy 0.000 claims abstract description 30
- 239000000843 powder Substances 0.000 claims abstract description 20
- 238000010146 3D printing Methods 0.000 claims abstract description 12
- 238000001513 hot isostatic pressing Methods 0.000 claims abstract description 10
- 239000002994 raw material Substances 0.000 claims abstract description 7
- 238000010438 heat treatment Methods 0.000 claims description 26
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 20
- 239000000543 intermediate Substances 0.000 claims description 20
- XKRFYHLGVUSROY-UHFFFAOYSA-N Argon Chemical compound [Ar] XKRFYHLGVUSROY-UHFFFAOYSA-N 0.000 claims description 16
- 229910052757 nitrogen Inorganic materials 0.000 claims description 11
- 239000007788 liquid Substances 0.000 claims description 10
- 230000001105 regulatory effect Effects 0.000 claims description 10
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- 229910052760 oxygen Inorganic materials 0.000 claims description 8
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- 229910052734 helium Inorganic materials 0.000 description 4
- SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 description 4
- 229910052751 metal Inorganic materials 0.000 description 4
- 239000002184 metal Substances 0.000 description 4
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- MCMNRKCIXSYSNV-UHFFFAOYSA-N ZrO2 Inorganic materials O=[Zr]=O MCMNRKCIXSYSNV-UHFFFAOYSA-N 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
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- 229910021645 metal ion Inorganic materials 0.000 description 2
- RVTZCBVAJQQJTK-UHFFFAOYSA-N oxygen(2-);zirconium(4+) Chemical compound [O-2].[O-2].[Zr+4] RVTZCBVAJQQJTK-UHFFFAOYSA-N 0.000 description 2
- 238000004626 scanning electron microscopy Methods 0.000 description 2
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- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 229920010741 Ultra High Molecular Weight Polyethylene (UHMWPE) Polymers 0.000 description 1
- WAIPAZQMEIHHTJ-UHFFFAOYSA-N [Cr].[Co] Chemical class [Cr].[Co] WAIPAZQMEIHHTJ-UHFFFAOYSA-N 0.000 description 1
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- RKTYLMNFRDHKIL-UHFFFAOYSA-N copper;5,10,15,20-tetraphenylporphyrin-22,24-diide Chemical compound [Cu+2].C1=CC(C(=C2C=CC([N-]2)=C(C=2C=CC=CC=2)C=2C=CC(N=2)=C(C=2C=CC=CC=2)C2=CC=C3[N-]2)C=2C=CC=CC=2)=NC1=C3C1=CC=CC=C1 RKTYLMNFRDHKIL-UHFFFAOYSA-N 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229910052588 hydroxylapatite Inorganic materials 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 208000029791 lytic metastatic bone lesion Diseases 0.000 description 1
- 229910000734 martensite Inorganic materials 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 1
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- 229910001256 stainless steel alloy Inorganic materials 0.000 description 1
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- 238000011277 treatment modality Methods 0.000 description 1
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- 238000012795 verification Methods 0.000 description 1
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Abstract
本发明公开了含氧化层锆铌合金踝关节假体系统及制备方法,步骤:以锆铌合金粉为原料,经3D打印一体成型分别得到距骨部件的中间产物和胫骨部件的中间产物,经热等静压、深冷和表面氧化,得到距骨部件或胫骨部件;所述胫骨部件与距骨部件滑动连接;在距骨部件本体的下表面和两个第一固定柱的外表面以及胫骨部件本体的上表面和两个第二固定柱的外表面设置有骨小梁,提高假体的骨长入性能。本发明采用3D打印一体成型,骨小梁与实体结合强度高,不易脱落,提升假体寿命。本发明一体化实现骨整合界面的优良生物相容性、骨长入性和摩擦界面的超强耐磨性、低磨损率;本发明无需使用衬垫,解决现有技术中胫骨部件和衬垫之间微动的难题。
Description
技术领域
本发明涉及一种踝关节假体,尤其是涉及含氧化层锆铌合金踝关节假体系统及制备方法。
背景技术
关节置换术是目前临床上针对终末期关节疾患的有效治疗方式。但是,关节假体长期植入人体,在体内复杂生理、力学环境长期作用下,软体材料,如:超高分子量聚乙烯(UHMWPE),会因关节面磨损产生大量磨屑颗粒,磨屑聚集可引起一系列组织反应,导致骨溶解,无菌松动,假体失效。并且,对于钴铬合金、镍钛合金和不锈钢合金等金属关节材料,会在体内摩擦、腐蚀长期共同作用下释放有毒金属离子,如Cr、Ni、Mn、Mo和V等离子,一方面会引起过敏反应;另一方面也存在其它不明潜在危害。
锆铌合金具有优异耐腐蚀性、力学性能和良好生物相容性,被逐渐应用于医疗器械领域。锆铌合金可与N、C、O等元素反应在表面形成坚硬的氧化层,具有优异耐磨性和低磨损率,可降低对软体材料的磨损,即具有关节界面的优异耐磨性;且氧化层可降低金属离子的释放,具有优异生物相容性,即具有骨整合界面的优异生物相容性。低磨损率的关节面与骨长入性能优异的骨整合界面(骨小梁)有机配伍,可使假体同时实现两界面优点。
目前临床上使用的关节假体包括骨水泥固定型假体和非骨水泥固定型假体。有研究显示,采用骨水泥固定的假体在骨水泥凝固过程中产生的高温会造成部分骨细胞的死亡,影响后期的骨生长。非骨水泥固定型假体由于良好的骨生长性能,因此得到了越来越广泛的应用。非骨水泥固定型假体的骨整合界面通常采用表面喷涂羟基磷灰石涂层或钛涂层,其优点是克服了骨水泥凝固时的高温,有利于骨细胞的生长,缺点是表面涂层容易脱落,影响使用效果,严重时会造成手术失败。随着金属3D打印技术的发展,采用3D打印技术在假体与宿主骨组织接触的表面打印多孔结构的金属骨小梁不仅解决了涂层的脱落问题,而且实现了骨组织从骨长上向骨长入的转变。但3D打印产品实体部分易存在显微组织不均匀、内部缺陷等问题,力学性能不佳;骨小梁部分结构中粉末未能得到良好熔结,力学性能差。
因此,制备一种力学性能优异,且同时具有两界面优点的踝关节假体系统,具有重要意义。
发明内容
本发明的主要目的在于克服现有技术不足,提供含氧化层锆铌合金踝关节假体系统。
本发明的第二个目的是提供含氧化层锆铌合金踝关节假体系统的制备方法。
本发明的技术方案概述如下:
含氧化层锆铌合金踝关节假体系统的制备方法,包括如下步骤:
1)以锆铌合金粉为原料,经3D打印一体成型分别得到距骨部件的第一中间产物和胫骨部件的第一中间产物,将两种第一中间产物放入热等静压炉,在氦气或氩气保护下,升温至1250℃-1400℃,在140MPa-180MPa,恒温放置1h-3h,降至常压,随炉冷却至200℃以下取出,得到两种第二中间产物;
2)将两种第二中间产物放置于程序性降温盒中以1℃/min的速度降温至-80℃~-120℃,恒温放置5h-10h,从程序性降温盒中取出;在液氮中再放置16h-36h,调节温度至室温,得到两种第三中间产物;
3)将两种第三中间产物放置于程序性降温盒中以1℃/min的速度降温至-80℃~-120℃,恒温放置5h-10h;从程序性降温盒中取出;在液氮中再放置16h-36h,调节温度至室温;得两种第四中间产物;
4)将两种第四中间产物进行机加工修整、抛光、清洗和干燥,得两种第五中间产物,所述距骨部件第五中间产物的上表面和胫骨部件的第五中间产物的下表面的粗糙度Ra≤0.050μm;
5)将两种第五中间产物放置于管式炉内,通入含氧质量百分比为5%-15%的常压氦气或氩气,以5℃/min-20℃/min加热至500℃-700℃,以0.4℃/min-0.9℃/min降温至400℃-495℃,再自然冷却至200℃以下取出,分别得到距骨部件或胫骨部件;
距骨部件的第一中间产物、第二中间产物、第三中间产物、第四中间产物和第五中间产物的结构与距骨部件的结构相同。
胫骨部件的第一中间产物、第二中间产物、第三中间产物、第四中间产物和第五中间产物的结构与距骨部件的结构相同。
所述含氧化层锆铌合金踝关节假体系统的结构包括距骨部件1和胫骨部件2,所述距骨部件1包括距骨部件本体4和设置在距骨部件本体下表面前后的两个第一固定柱3;
所述胫骨部件2包括胫骨部件本体5和设置在胫骨部件本体上表面前后的两个第二固定柱6;
所述胫骨部件2与距骨部件1滑动连接;
在距骨部件本体4的下表面和两个第一固定柱3的外表面设置有骨小梁7,在胫骨部件本体5的上表面和两个第二固定柱6的外表面设置有骨小梁7,骨小梁7孔径为0.35mm-1.10mm;孔隙率为55%-78%;通孔率为100%;厚度为0.5mm-3mm。
所述锆铌合金粉的化学成分按质量百分比为85.6%-96.5%的Zr,1.0%-12.5%的Nb,其余为不可避免的杂质;所述锆铌合金粉的粒径为45μm-150μm。
步骤2)、3)所述调节温度为:升温至-120℃~-80℃,恒温保持3h-5h;再升温至-40℃~-20℃,恒温保持3h-5h;再升温至4℃-8℃,恒温保持1h-3h,升温。
上述方法制备的含氧化层锆铌合金踝关节假体系统。
本发明具有以下有益效果:
本发明含氧化层锆铌合金踝关节假体系统的骨小梁设置,提高假体的骨长入性能。本发明采用3D打印一体成型,解决传统机加工无法制备复杂结构的难题,且骨小梁与实体结合强度高,不易脱落,提升假体寿命。本发明可一体化实现骨整合界面的优良生物相容性、骨长入性和摩擦界面的超强耐磨性、低磨损率。本发明的距骨部件和胫骨部件的氧化层与基体之间存在富氧层,富氧层有过渡层作用,提高氧化层与基体之间附着力,避免氧化层脱落;且氧化层硬度高。本发明的含氧化层锆铌合金踝关节假体系统低伪影,对核磁干扰小,可进行核磁检测。本发明无需使用衬垫,解决现有技术中胫骨部件和衬垫之间微动的难题。
附图说明
图1为本发明含氧化层锆铌合金踝关节假体系统示意图。
图2为距骨部件的轴测图。
图3为距骨部件轴测图(不含骨小梁)。
图4为胫骨部件轴测图。
图5为胫骨部件轴测图(不含骨小梁)。
图6为对照组1的胫骨部件的实体部分金相显微结构图(A为放大50倍观察;B为放大500倍观察)。
图7为实施例1的胫骨部件的未进行制备方法中步骤4)和步骤5)的实体部分金相显微结构图(A为放大50倍观察;B为放大500倍观察)。
图8为对照组1的胫骨部件的骨小梁部分SEM图。
图9为实施例1的胫骨部件的未进行制备方法中步骤4)和步骤5)的骨小梁部分SEM图。
图10为实施例1的胫骨部件的氧化层与基体的横截面SEM图。
图11为实施例1的胫骨部件的氧化层表面的XRD曲线。
具体实施方式
下面通过具体实施例对本发明作进一步的说明。
实施例1
含氧化层锆铌合金踝关节假体系统的制备方法,包括如下步骤:
1)以锆铌合金粉为原料,经3D打印一体成型分别得到距骨部件的第一中间产物或胫骨部件的第一中间产物,将两种第一中间产物放入热等静压炉,在氩气保护下,升温至1250℃,在180MPa,恒温放置3h,降至常压,随炉冷却至200℃以下取出,得到两种第二中间产物;
2)将两种第二中间产物放置于程序性降温盒中以1℃/min的速度降温至-80℃,恒温放置10h,从程序性降温盒中取出;在液氮中再放置16h,调节温度至室温,得到两种第三中间产物;
3)将两种第三中间产物放置于程序性降温盒中以1℃/min的速度降温至-80℃,恒温放置10h;从程序性降温盒中取出;在液氮中再放置16h,调节温度至室温;得两种第四中间产物;
4)将两种第四中间产物进行机加工修整、抛光、清洗和干燥,得两种第五中间产物,所述距骨部件第五中间产物的上表面和胫骨部件的第五中间产物的下表面的粗糙度Ra=0.012μm;
5)将两种第五中间产物放置于管式炉内,通入含氧质量百分比为5%的常压氩气,以5℃/min加热至500℃,以0.4℃/min降温至400℃,再自然冷却至200℃以下取出,分别得到距骨部件或胫骨部件;
距骨部件的第一中间产物、第二中间产物、第三中间产物、第四中间产物和第五中间产物的结构与距骨部件的结构相同。
胫骨部件的第一中间产物、第二中间产物、第三中间产物、第四中间产物和第五中间产物的结构与距骨部件的结构相同。
所述含氧化层锆铌合金踝关节假体系统的结构,(见图1-图5)包括距骨部件1和胫骨部件2;所述距骨部件1包括距骨部件本体4和设置在距骨部件本体下表面前后的两个第一固定柱3;所述胫骨部件2包括胫骨部件本体5和设置在胫骨部件本体上表面前后的两个第二固定柱6;所述胫骨部件2与距骨部件1滑动连接;
在距骨部件本体4的下表面和两个第一固定柱3的外表面设置有骨小梁7,在胫骨部件本体5的上表面和两个第二固定柱6的外表面设置有骨小梁7;骨小梁7孔径为0.80mm,孔隙率为72%,通孔率为100%;厚度为0.5mm。
所述锆铌合金粉的化学成分按质量百分比为85.6%的Zr,12.5%的Nb,其余为不可避免的杂质;所述锆铌合金粉的粒径为45μm-150μm。
步骤2)、3)所述调节温度为:升温至-120℃,恒温保持5h;再升温至-40℃,恒温保持5h;再升温至4℃,恒温保持3h,升温。
所述距骨部件1安装于根骨上,所述胫骨部件2安装于胫骨底部;
实施例2
含氧化层锆铌合金踝关节假体系统的制备方法,包括如下步骤:
1)以锆铌合金粉为原料,经3D打印一体成型分别得到距骨部件的第一中间产物或胫骨部件的第一中间产物,将两种第一中间产物放入热等静压炉,在氦气保护下,升温至1325℃,在160MPa,恒温放置2h,降至常压,随炉冷却至200℃以下取出,得到两种第二中间产物;
2)将两种第二中间产物放置于程序性降温盒中以1℃/min的速度降温至-100℃,恒温放置7h,从程序性降温盒中取出;在液氮中再放置24h,调节温度至室温,得到两种第三中间产物;
3)将两种第三中间产物放置于程序性降温盒中以1℃/min的速度降温至-100℃,恒温放置7h;从程序性降温盒中取出;在液氮中再放置24h,调节温度至室温;得两种第四中间产物;
4)将两种第四中间产物进行机加工修整、抛光、清洗和干燥,得两种第五中间产物,所述距骨部件第五中间产物的上表面和胫骨部件的第五中间产物的下表面的粗糙度Ra=0.035μm;
5)将两种第五中间产物放置于管式炉内,通入含氧质量百分比为10%的常压氦气,以15℃/min加热至600℃,以0.7℃/min降温至450℃,再自然冷却至200℃以下取出,分别得到距骨部件或胫骨部件;
距骨部件的第一中间产物、第二中间产物、第三中间产物、第四中间产物和第五中间产物的结构与距骨部件的结构相同。
胫骨部件的第一中间产物、第二中间产物、第三中间产物、第四中间产物和第五中间产物的结构与距骨部件的结构相同。
所述含氧化层锆铌合金踝关节假体系统的结构包括距骨部件1和胫骨部件2;所述距骨部件1包括距骨部件本体4和设置在距骨部件本体下表面前后的两个第一固定柱3;所述胫骨部件2包括胫骨部件本体5和设置在胫骨部件本体上表面前后的两个第二固定柱6;所述胫骨部件2与距骨部件1滑动连接;在距骨部件本体4的下表面和两个第一固定柱3的外表面设置有骨小梁7,在胫骨部件本体5的上表面和两个第二固定柱6的外表面设置有骨小梁7;骨小梁7孔径为0.35mm,孔隙率为55%,通孔率为100%,厚度为1.5mm。
所述锆铌合金粉的化学成分按质量百分比为93.4%的Zr,5.1%的Nb,其余为不可避免的杂质;所述锆铌合金粉的粒径为45μm-150μm。
步骤2)、3)所述调节温度为:升温至-100℃,恒温保持4h;再升温至-30℃,恒温保持4h;再升温至6℃,恒温保持2h,升温。
实施例3
含氧化层锆铌合金踝关节假体系统的制备方法,包括如下步骤:
1)以锆铌合金粉为原料,经3D打印一体成型分别得到距骨部件的第一中间产物或胫骨部件的第一中间产物,将两种第一中间产物放入热等静压炉,放入热等静压炉,在氩气保护下,升温至1400℃,在140MPa,恒温放置1h,降至常压,随炉冷却至200℃以下取出,得到两种第二中间产物;
2)将两种第二中间产物放置于程序性降温盒中以1℃/min的速度降温至-120℃,恒温放置5h,从程序性降温盒中取出;在液氮中再放置36h,调节温度至室温,得到两种第三中间产物;
3)将两种第三中间产物放置于程序性降温盒中以1℃/min的速度降温至-120℃,恒温放置5h;从程序性降温盒中取出;在液氮中再放置36h,调节温度至室温;得两种第四中间产物;
4)将两种第四中间产物进行机加工修整、抛光、清洗和干燥,得两种第五中间产物,所述距骨部件第五中间产物的上表面和胫骨部件的第五中间产物的下表面的粗糙度Ra=0.050μm;
5)将两种第五中间产物放置于管式炉内,通入含氧质量百分比为15%的常压氩气,以20℃/min加热至700℃,以0.9℃/min降温至495℃,再自然冷却至200℃以下取出,分别得到距骨部件或胫骨部件;
距骨部件的第一中间产物、第二中间产物、第三中间产物、第四中间产物和第五中间产物的结构与距骨部件的结构相同。
胫骨部件的第一中间产物、第二中间产物、第三中间产物、第四中间产物和第五中间产物的结构与距骨部件的结构相同。
所述含氧化层锆铌合金踝关节假体系统的结构包括距骨部件1和胫骨部件2;所述距骨部件1包括距骨部件本体4和设置在距骨部件本体下表面前后的两个第一固定柱3;所述胫骨部件2包括胫骨部件本体5和设置在胫骨部件本体上表面前后的两个第二固定柱6;所述胫骨部件2与距骨部件1滑动连接;在距骨部件本体4的下表面和两个第一固定柱3的外表面设置有骨小梁7,在胫骨部件本体5的上表面和两个第二固定柱6的外表面设置有骨小梁7;骨小梁7孔径为1.10mm,孔隙率为78%,通孔率为100%;厚度为3mm。
所述锆铌合金粉的化学成分按质量百分比为96.5%的Zr,1.0%的Nb,其余为不可避免的杂质;所述锆铌合金粉的粒径为45μm-150μm。
步骤2)、3)所述调节温度为:升温至-80℃,恒温保持3h;再升温至-20℃,恒温保持3h;再升温至8℃,恒温保持1h,升温。
对照组1
以锆铌合金粉(同实施例1)为原料,经3D打印一体成型和机加工修整,得到结构同实施例1的踝关节假体系统。
实验验证:
倒置万能材料显微镜(Axio Vert.A1,德国蔡司zeiss公司,德国)对对照组1的胫骨部件的实体部分和实施例1的胫骨部件的未进行所述制备方法中步骤4)和步骤5)的实体部分进行金相显微组织观察。结果如图6和7所示,对照组1的胫骨部件的金相照片中可以观察到细小α马氏体,组织较细小,易产生应力集中,塑性较差;实施例1的胫骨部件的金相显示为α相,呈网篮结构,晶粒细化。结果提示,本发明所述胫骨部件的基体部分(不含氧化层)具有优异的强度和塑性。
扫描电子显微镜(Crossbeam340/550,蔡司,德国)对对照组1的胫骨部件的骨小梁部分和实施例1的胫骨部件的未进行所述制备方法中步骤4)和步骤5)骨小梁部分进行观察分析,结果如图8-9所示,与对照组1相比,实施例1的胫骨部件的骨小梁结构中锆铌合金粉发生进一步熔结,提示骨小梁综合性能提高。
电子万能试验机(UTM5105,深圳三思纵横科技股份有限公司,中国)对实施例1的胫骨部件未进行所述制备方法中步骤4)和步骤5)的实体压缩试件(试件大小为:8*8*10mm3)和对照组1的胫骨部件的实体压缩试件(试件大小为:8*8*10mm3)进行压缩性能测试,实施例1和对照组1的实体压缩试件各5个。结果如表1所示,实施例1的抗压屈服强度为546.72MPa,优于对照组1(P<0.05),提示本发明制得的胫骨部件的实体部分具有优异抗压缩性能。
表1对照组1和实施例1的实体试件抗压缩实验结果(*P<0.05,与对照组1比较)
电子万能试验机(UTM5105,深圳三思纵横科技股份有限公司,中国)对对照组1的胫骨部件的孔径为0.80mm,孔隙率为72%,通孔率为100%的骨小梁压缩试件和实施例1的胫骨部件的未进行所述制备方法中步骤4)和步骤5)的孔径为0.80mm,孔隙率为72%,通孔率为100%的骨小梁压缩试件(试件大小为:8*8*10mm3)进行压缩实验,对照组1和实施例1的骨小梁压缩试件各5个。结果如表2所示,实施例1的骨小梁屈服强度为18.39MPa,显著高于对照组1(P<0.05),提示本发明制得的胫骨部件的骨小梁部分抗压性能优异。
表2对照组1和实施例1的骨小梁试件抗压缩实验结果(*P<0.05,与对照组1比较)
扫描电子显微镜(Crossbeam340/550,蔡司,德国)对实施例1的胫骨部件的锆铌合金基体与氧化层的横截面进行观察,(见图10)。并对实施例2、3的胫骨部件的锆铌合金基体与氧化层的横截面进行观察,其氧化层厚度分别为10.3μm、17.2μm和20.6μm,且氧化层与锆铌合金基体之间存在富氧层,增强锆铌金属基体与氧化层之间的结合力。
XRD(D8DISCOVER,Bruker,德国)对实施例1的胫骨部件的氧化层进行分析(如图11所示),氧化层包含单斜相二氧化锆和四方相二氧化锆。
显微硬度仪(MHVS-1000PLUS,上海奥龙星迪检测设备有限公司,中国)对实施例1-3的胫骨部件进行显微硬度测量,测试载荷为0.05kg,试件载荷时间为20s,每个试件取8个点。实施例1-3测得平均硬度值为1948.6Hv、1923.7Hv和1967.2Hv,提示本发明的胫骨部件的氧化层硬度高。
实验证明,实施例2、3制备的胫骨部件、距骨部件和实施例1制备的距骨部件的骨小梁部分的锆铌合金粉熔结程度、抗压强度,实体部分抗压性能、金相组织,氧化层的晶体结构、厚度和硬度与实施例1制备的胫骨部件相似。
Claims (2)
1.含氧化层锆铌合金踝关节假体系统的制备方法,其特征是包括如下步骤:
1)以锆铌合金粉为原料,经3D打印一体成型分别得到距骨部件的第一中间产物或胫骨部件的第一中间产物,将两种第一中间产物放入热等静压炉,在氩气保护下,升温至1250℃,在180MPa,恒温放置3h,降至常压,随炉冷却至200℃以下取出,得到两种第二中间产物;
2)将两种第二中间产物放置于程序性降温盒中以1℃/min的速度降温至-80℃,恒温放置10h,从程序性降温盒中取出;在液氮中再放置16h,调节温度至室温,得到两种第三中间产物;
3)将两种第三中间产物放置于程序性降温盒中以1℃/min的速度降温至-80℃,恒温放置10h;从程序性降温盒中取出;在液氮中再放置16h,调节温度至室温;得两种第四中间产物;
4)将两种第四中间产物进行机加工修整、抛光、清洗和干燥,得两种第五中间产物,所述距骨部件第五中间产物的上表面和胫骨部件的第五中间产物的下表面的粗糙度Ra=0.012μm;
5)将两种第五中间产物放置于管式炉内,通入含氧质量百分比为5%的常压氩气,以5℃/min加热至500℃,以0.4℃/min降温至400℃,再自然冷却至200℃以下取出,分别得到距骨部件或胫骨部件;
所述含氧化层锆铌合金踝关节假体系统的结构,包括距骨部件(1)和胫骨部件(2);所述距骨部件(1)包括距骨部件本体(4)和设置在距骨部件本体下表面前后的两个第一固定柱(3);所述胫骨部件(2)包括胫骨部件本体(5)和设置在胫骨部件本体上表面前后的两个第二固定柱(6);所述胫骨部件(2)与距骨部件(1)滑动连接;
在距骨部件本体(4)的下表面和两个第一固定柱(3)的外表面设置有骨小梁(7),在胫骨部件本体(5)的上表面和两个第二固定柱(6)的外表面设置有骨小梁(7);骨小梁(7)孔径为0.80mm,孔隙率为72%,通孔率为100%;厚度为0.5mm;
所述锆铌合金粉的化学成分按质量百分比为85.6%的Zr,12.5%的Nb,其余为不可避免的杂质;所述锆铌合金粉的粒径为45μm-150μm。
2.权利要求1的方法制备的含氧化层锆铌合金踝关节假体系统。
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