CN112404433B - 含氧化层锆铌合金分区骨小梁单间室胫骨平台及制备方法 - Google Patents

含氧化层锆铌合金分区骨小梁单间室胫骨平台及制备方法 Download PDF

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Publication number
CN112404433B
CN112404433B CN202011195196.6A CN202011195196A CN112404433B CN 112404433 B CN112404433 B CN 112404433B CN 202011195196 A CN202011195196 A CN 202011195196A CN 112404433 B CN112404433 B CN 112404433B
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Prior art keywords
trabecular bone
zirconium
niobium alloy
trabecular
tibial plateau
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CN202011195196.6A
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CN112404433A (zh
Inventor
刘念
李莉
王献抗
曹雨
杨友
周红秀
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Jiasite Medical Equipment Tianjin Co ltd
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Jiasite Huajian Medical Equipment Tianjin co ltd
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Priority to CN202011195196.6A priority Critical patent/CN112404433B/zh
Publication of CN112404433A publication Critical patent/CN112404433A/zh
Priority to PCT/CN2021/101285 priority patent/WO2022088703A1/zh
Priority to EP21884444.7A priority patent/EP4086367A4/en
Priority to JP2022545387A priority patent/JP7324374B2/ja
Priority to US17/907,912 priority patent/US20230301792A1/en
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Abstract

本发明公开了含氧化层锆铌合金分区骨小梁单间室胫骨平台及制备方法，步骤：以锆铌合金粉为原料，经3D打印一体成型得到含氧化层锆铌合金分区骨小梁单间室胫骨平台的中间产物，再经热等静压，深冷氧化，即得含氧化层锆铌合金分区骨小梁单间室胫骨平台，本发明的半胫骨平台托的下表面及带有长圆孔的半椭圆形龙骨表面设置有骨小梁，本发明设置梯度分布骨小梁结构，可降低假体与骨界面之间的微动，降低假体对骨组织的应力遮挡效应，使胫骨平台骨组织应力均一，具有优异骨长入性能，提高初始稳定性与长期稳定性。本发明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。

Description

含氧化层锆铌合金分区骨小梁单间室胫骨平台及制备方法
技术领域
本发明属于人工关节领域，尤其是涉及含氧化层锆铌合金分区骨小梁单间室胫骨平台及制备方法。
背景技术
单间室膝关节假体用于对膝关节单侧病变间室进行表面置换，不但具有手术切口小，术中截骨量少，而且不影响或较少影响其他正常关节间室，不破坏伸膝装置，可保留十字韧带及软骨，因此单髁膝关节置换术后恢复快、并发症少，保存了膝关节的正常运动和本体感觉。
目前，单间室膝关节假体根据固定方式不同，分为骨水泥固定与生物固定。骨水泥固定易引发临床中骨水泥综合症：骨水泥碎裂、对骨组织造成热灼伤、感染等，同时，易产生临床上生理性透亮线的误判，误以为假体松动，造成术后大量不必要的翻修。
生物型单间室膝关节假体可实现骨组织与假体界面的有效嵌合，可避免骨水泥固定所带来的缺陷。目前，生物型单间室膝关节假体多为双涂层工艺(钛微孔+HA涂层)，存在涂层脱落、涂层喷涂厚度不均匀、进而影响假体长期固定的风险。另外，人工关节置换失败的主要原因是假体松动，假体与骨之间巨大的刚度不匹配所引发的应力遮挡将引起假体周围骨重塑并导致假体松动。现有生物型单间室膝关节假体的弹性模量远大于骨组织，大幅度增加假体与骨界面间的应力遮挡效应，降低成骨细胞的形成，最终导致假体松动。3D打印均匀骨小梁单间室膝关节假体可在一定程度上降低应力遮挡效应，提高假体的远期生存率，由于骨组织在不同区域的力学差异性，以及假体在不同区域的力学环境差异性，将造成均匀骨小梁假体固定的不均匀性，对假体的长期稳定性造成一定的影响，也将增加其失败的风险。
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，即具有关节面界面的优异耐磨性；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。但现有技术尚未有采用锆铌合金制备含氧化层锆铌合金分区骨小梁单间室胫骨平台的报道。
3D打印技术，作为一种增材制造技术，突破面向制造工艺的产品设计概念，实现面向性能的产品设计理念，即解决复杂零件难以整体成型难题，又减少机加工制造带来的原材料和能源浪费。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。
针对现有技术的不足之处，本领域的技术人员致力于开发力学性能优异、同时实现两界面优点的含氧化层锆铌合金分区骨小梁单间室胫骨平台，提高单间室胫骨平台的固定可靠性以及假体的初始稳定与长期稳定性。
发明内容
本发明的目的在于克服现有技术不足，提供含氧化层锆铌合金分区骨小梁单间室胫骨平台。
本发明的第二个目的是提供含氧化层锆铌合金分区骨小梁单间室胫骨平台的制备方法。
本发明的技术方案概述如下：
含氧化层锆铌合金分区骨小梁单间室胫骨平台的制备方法，包括如下步骤：
1)以锆铌合金粉为原料，经3D打印一体成型得到含氧化层锆铌合金分区骨小梁单间室胫骨平台的第一中间产物，将所述第一中间产物放入热等静压炉，在惰性气体保护下，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，得到第二中间产物；
2)将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，得到第三中间产物；
3)将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；得第四中间产物；
4)将第四中间产物进行机加工修整、抛光、清洗和干燥，得第五中间产物，所述第五中间产物半胫骨平台托上表面的粗糙度Ra≤0.050μm；
5)将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％的常压惰性气体，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，得到含氧化层锆铌合金分区骨小梁单间室胫骨平台；
所述惰性气体为氦气或氩气；
所述含氧化层锆铌合金分区骨小梁单间室胫骨平台的结构，包括半胫骨平台托1，在所述半胫骨平台托的直线边的上表面设置有侧壁2，在所述半胫骨平台托的下表面近侧壁处设置有带有长圆孔的半椭圆形龙骨3，所述半胫骨平台托的下表面及带有长圆孔的半椭圆形龙骨表面设置有骨小梁，在半胫骨平台托的下表面除连接所述带有长圆孔的半椭圆形龙骨以外的其他部分设置的骨小梁分为前侧骨小梁8和后侧骨小梁9，所述前侧骨小梁8和后侧骨小梁9的分区线6垂直于所述侧壁2设置或与侧壁夹角4呈45°-70°设置；
所述带有长圆孔的半椭圆形龙骨表面设置的骨小梁分为上部骨小梁10和下部骨小梁11，所述上部骨小梁和下部骨小梁的分区线为第二分区线12，第二分区线位于长圆孔顶下表面处或长圆孔底上表面处；
上部骨小梁10的孔径和孔隙率依次小于后侧骨小梁、前侧骨小梁和下部骨小梁。
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。
所述分区线6垂直于所述侧壁2设置，所述分区线6与侧壁2的交点5将侧壁分为侧壁前段13和侧壁后段14，侧壁前段13和侧壁后段14的比值为(2-3):1。
所述分区线6与侧壁夹角4呈45°-70°设置；分区线6与侧壁2的交点5位于侧壁中心。
所述上部骨小梁10的孔径为351μm-450μm，孔隙率为60％-65％；后侧骨小梁9的孔径为451μm-550μm，孔隙率为66％-70％；前侧骨小梁8的孔径为551μm-650μm，孔隙率为70％-75％；下部骨小梁11的孔径为651μm-750μm，孔隙率为76％-80％。
所述上部骨小梁10、后侧骨小梁9前侧骨小梁8和下部骨小梁11的厚度相等，为1mm-2mm。
上述方法制备的含氧化层锆铌合金分区骨小梁单间室胫骨平台。
本发明的优点：
本发明含氧化层锆铌合金分区骨小梁单间室胫骨平台的半胫骨平台托下表面与龙骨表面均设置梯度分布骨小梁结构，可降低假体与骨界面之间的微动，降低假体对骨组织的应力遮挡效应，使胫骨平台骨组织应力均一，具有优异骨长入性能，提高初始稳定性与长期稳定性。
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。
本发明含氧化层锆铌合金分区骨小梁单间室胫骨平台的骨小梁部分具有优异抗压性能；实体部分抗压屈服强度增强，塑性增强。
本发明所述含氧化层锆铌合金分区骨小梁单间室胫骨平台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。
本发明所述含氧化层锆铌合金分区骨小梁单间室胫骨平台的陶瓷层与基体之间存在富氧层，富氧层有过渡层作用，提高陶瓷层与基体之间附着力，避免陶瓷层脱落；且陶瓷层硬度高。
本发明所述含氧化层锆铌合金分区骨小梁单间室胫骨平台低伪影，对核磁干扰小，可进行核磁检测。
附图说明
图1为含氧化层锆铌合金分区骨小梁单间室胫骨平台的结构示意图。
图2为含氧化层锆铌合金分区骨小梁单间室胫骨平台的轴测图。
图3为含氧化层锆铌合金分区骨小梁单间室胫骨平台的主视图(分区线12通过长圆孔底上表面)。
图4为含氧化层锆铌合金分区骨小梁单间室胫骨平台的主视图(分区线12通过长圆孔顶下表面)。
图5为含氧化层锆铌合金分区骨小梁单间室胫骨平台仰视图(分区线6与侧壁夹角呈60°，交点位于侧壁中部)。
图6为含氧化层锆铌合金分区骨小梁单间室胫骨平台仰视图(分区线6垂直于侧壁)。
图7为对照组1的均匀骨小梁单间室胫骨平台有限元模型与宿主骨组织有限元模型界面的微动云图。
图8为实施例1的含氧化层锆铌合金分区骨小梁单间室胫骨平台有限元模型与宿主骨组织有限元模型界面的微动云图。
图9为对照组1的均匀骨小梁单间室胫骨平台有限元模型的接触压力云图。
图10为实施例1的含氧化层锆铌合金分区骨小梁单间室胫骨平台有限元模型的接触压力云图。
图11为对照组1的均匀骨小梁单间室胫骨平台有限元模型的等效应力云图。
图12为实施例1的含氧化层锆铌合金分区骨小梁单间室胫骨平台有限元模型的等效应力云图。
图13为用于对照组1有限元分析的胫骨平台骨组织有限元模型的等效应力云图。
图14为用于实施例1有限元分析的胫骨平台骨组织有限元模型的等效应力云图。
图15为对照组2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16为实施例1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17为对照组2的骨小梁部分SEM图。
图18为实施例1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19为实施例1的氧化层与基体的横截面SEM图。
图20为实施例1的氧化层表面的XRD曲线。
具体实施方式
下面结合具体实施例对本发明作进一步的说明。
实施例1
含氧化层锆铌合金分区骨小梁单间室胫骨平台的制备方法，包括如下步骤：
1)以锆铌合金粉为原料，经3D打印一体成型得到含氧化层锆铌合金分区骨小梁单间室胫骨平台的第一中间产物，将第一中间产物放入热等静压炉，在氦气保护下，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，得到第二中间产物；
2)将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，得到第三中间产物；
3)将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；得第四中间产物；
步骤2)、3)调节温度具体步骤是：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。
4)将第四中间产物进行机加工修整、抛光、清洗和干燥，得第五中间产物，所述第五中间产物半胫骨平台托上表面的粗糙度Ra＝0.012μm；
5)将第五中间产物放置于管式炉内，通入含氧质量百分比为5％的常压氦气，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，得到含氧化层锆铌合金分区骨小梁单间室胫骨平台；
含氧化层锆铌合金分区骨小梁单间室胫骨平台的第一中间产物、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与含氧化层锆铌合金分区骨小梁单间室胫骨平台的结构相同。
所述含氧化层锆铌合金分区骨小梁单间室胫骨平台(见图1-2)的结构，包括半胫骨平台托1，在所述半胫骨平台托的直线边的上表面设置有侧壁2，在所述半胫骨平台托的下表面近侧壁处设置有带有长圆孔的半椭圆形龙骨3，所述半胫骨平台托的下表面及带有长圆孔的半椭圆形龙骨表面设置有骨小梁，在半胫骨平台托的下表面除连接所述带有长圆孔的半椭圆形龙骨以外的其他部分设置的骨小梁分为前侧骨小梁8和后侧骨小梁9，所述前侧骨小梁8和后侧骨小梁9的分区线6垂直于所述侧壁2设置(见图6)；所述分区线6与侧壁2的交点5将侧壁分为侧壁前段13和侧壁后段14，侧壁前段13和侧壁后段14的比值为2:1(也可以为3:1)；
所述带有长圆孔的半椭圆形龙骨表面设置的骨小梁分为上部骨小梁10和下部骨小梁11，所述上部骨小梁和下部骨小梁的分区线为第二分区线12，第二分区线位于长圆孔顶下表面处(见图4)；
锆铌合金粉的化学成分按质量百分比分别为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45-150μm，购置于西安赛隆金属材料有限责任公司。
所述上部骨小梁10的孔径为400μm，孔隙率为63％；
后侧骨小梁9的孔径为500μm，孔隙率为68％；
前侧骨小梁8的孔径为600μm，孔隙率为73％；
下部骨小梁11的孔径为700μm，孔隙率为78％。
所述上部骨小梁10、后侧骨小梁9、前侧骨小梁8和下部骨小梁11的厚度相等，为1.5mm。
实施例2
含氧化层锆铌合金分区骨小梁单间室胫骨平台的制备方法，包括如下步骤：
1)以锆铌合金粉为原料，经3D打印一体成型得到含氧化层锆铌合金分区骨小梁单间室胫骨平台的第一中间产物，将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，得到第二中间产物；
2)将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，得到第三中间产物；
3)将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；得第四中间产物；
步骤2)、3)调节温度的步骤为：升温至-100℃，恒温保持4h；再升温至-30℃，恒温保持4h；升温至6℃恒温保持2h，升温；
4)将第四中间产物进行机加工修整、抛光、清洗和干燥，得第五中间产物，所述第五中间产物半胫骨平台托上表面的粗糙度Ra＝0.035μm；
5)将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，得到含氧化层锆铌合金分区骨小梁单间室胫骨平台；
含氧化层锆铌合金分区骨小梁单间室胫骨平台的第一中间产物、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与含氧化层锆铌合金分区骨小梁单间室胫骨平台的结构相同。
所述含氧化层锆铌合金分区骨小梁单间室胫骨平台的结构，包括半胫骨平台托1，在所述半胫骨平台托的直线边的上表面设置有侧壁2，在所述半胫骨平台托的下表面近侧壁处设置有带有长圆孔的半椭圆形龙骨3，所述半胫骨平台托的下表面及带有长圆孔的半椭圆形龙骨表面设置有骨小梁，在半胫骨平台托的下表面除连接所述带有长圆孔的半椭圆形龙骨以外的其他部分设置的骨小梁分为前侧骨小梁8和后侧骨小梁9，所述前侧骨小梁8和后侧骨小梁9的分区线6与侧壁夹角4(见图5)呈45°设置；分区线6与侧壁2的交点5位于侧壁中心；
所述带有长圆孔的半椭圆形龙骨表面设置的骨小梁分为上部骨小梁10和下部骨小梁11，所述上部骨小梁和下部骨小梁的分区线为第二分区线12，第二分区线位于长圆孔长圆孔底上表面处(见图3)；
所述锆铌合金粉的化学成分按质量百分比分别为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45-150μm，购置于西安赛隆金属材料有限责任公司；
所述上部骨小梁10的孔径为351μm，孔隙率为60％；
后侧骨小梁9的孔径为451μm，孔隙率为66％；
前侧骨小梁8的孔径为551μm，孔隙率为70％；
下部骨小梁11的孔径为651μm，孔隙率为76％。
所述上部骨小梁10、后侧骨小梁9、前侧骨小梁8和下部骨小梁11的厚度相等，为1mm。
实施例3
含氧化层锆铌合金分区骨小梁单间室胫骨平台的制备方法，包括如下步骤：
1)以锆铌合金粉为原料，经3D打印一体成型得到含氧化层锆铌合金分区骨小梁单间室胫骨平台的第一中间产物，将第一中间产物放入热等静压炉，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，得到第二中间产物；
2)将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，得到第三中间产物；
3)将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；得第四中间产物；
步骤2)、3)调节温度具体步骤是：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。
4)将第四中间产物进行机加工修整、抛光、清洗和干燥，得第五中间产物，所述第五中间产物半胫骨平台托上表面的粗糙度Ra＝0.050μm；
5)将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℃，自然冷却至200℃以下取出，得到含氧化层锆铌合金分区骨小梁单间室胫骨平台；
所述含氧化层锆铌合金分区骨小梁单间室胫骨平台的结构，包括半胫骨平台托1，在所述半胫骨平台托的直线边的上表面设置有侧壁2，在所述半胫骨平台托的下表面近侧壁处设置有带有长圆孔的半椭圆形龙骨3，所述半胫骨平台托的下表面及带有长圆孔的半椭圆形龙骨表面设置有骨小梁，在半胫骨平台托的下表面除连接所述带有长圆孔的半椭圆形龙骨以外的其他部分设置的骨小梁分为前侧骨小梁8和后侧骨小梁9，所述前侧骨小梁8和后侧骨小梁9的分区线6与侧壁夹角4呈70°设置；分区线6与侧壁2的交点5位于侧壁中心；
所述带有长圆孔的半椭圆形龙骨表面设置的骨小梁分为上部骨小梁10和下部骨小梁11，所述上部骨小梁和下部骨小梁的分区线为第二分区线12，第二分区线位于长圆孔顶下表面处；
所述锆铌合金粉的化学成分按质量百分比分别为96.5％的Zr，1％的Nb，其余为不可避免的杂质；所述锆铌合金粉的粒径为45-150μm，购置于西安赛隆金属材料有限责任公司；
所述上部骨小梁10的孔径为450μm，孔隙率为65％；
后侧骨小梁9的孔径为550μm，孔隙率为70％；
前侧骨小梁8的孔径为650μm，孔隙率为75％；
下部骨小梁11的孔径为750μm，孔隙率为80％。
所述上部骨小梁10、后侧骨小梁9、前侧骨小梁8和下部骨小梁11的厚度相等，为2mm。
对照组1
均匀骨小梁单间室胫骨平台的制备方法和结构与实施例1不同的是，
上部骨小梁、下部骨小梁、前侧骨小梁和后侧骨小梁为同一种骨小梁，其孔径为500μm，孔隙率为68％，骨小梁的厚度为1.5mm。
对照组2
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的单间室胫骨平台。
实验证明：
假体与骨界面可靠的生物固定，主要依赖于假体固定的初始稳定性。假体与骨界面间过度的相对运动将抑制骨整合过程。研究表明，假体-骨界面的微动超过50～150μm时，骨界面将形成大量的纤维组织，将降低假体固定强度，最终导致假体松动。实施例1和对照组1的有限元模型和简化的胫骨平台松质骨分区模型进行有限元分析得到微动云图，如图7-8所示，与对照组1的均匀骨小梁单间室胫骨平台相比，实施例1的含氧化层锆铌合金分区骨小梁单间室胫骨平台有限元模型与胫骨平台骨组织有限元模型界面间的微动最大值为4.50μm，降低约43％，提示本发明含氧化层锆铌合金分区骨小梁单间室胫骨平台植入人体后具有优异的初始稳定性。
实施例1和对照组1的有限元模型和简化的胫骨平台松质骨分区模型进行有限元分析得到接触压力云图(图9-图10)和等效应力云图(图11-图14)。与对照组1的均匀骨小梁胫骨平台相比，实施例1的含氧化层锆铌合金分区骨小梁单间室胫骨平台有限元模型的接触压力更均匀，提示骨长入性能均一；实施例1的含氧化层锆铌合金分区骨小梁单间室胫骨平台有限元模型的等效应力最大值为2.50MPa，降低约40％，相应胫骨平台骨组织有限元模型等效应力最大值为1.28MPa，升高约4％，提示本发明含氧化层锆铌合金分区骨小梁单间室胫骨平台降低应力遮挡效应，骨长入性能优异；结果表明本发明所述含氧化层锆铌合金分区骨小梁单间室胫骨平台具有优异且均一的骨长入性能，可避免假体长期植入后，因骨质疏松造成的假体松动，可获得长期稳定性。
有限元分析结果证明，实施例2、3的微动云图、接触压力云图、等效应力云图与实施例1相似。
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2的实体部分和实施例1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15和16所示，对照组2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，本发明所述含氧化层锆铌合金分区骨小梁单间室胫骨平台基体部分(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2的骨小梁部分和实施例1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17、图18所示，与对照组2相比，实施例1含氧化层锆铌合金分区骨小梁单间室胫骨平台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2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2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2(P＜0.05)，提示本发明含氧化层锆铌合金分区骨小梁单间室胫骨平台实体部分具有优异抗压缩性能。
表1对照组2和实施例1的实体试件抗压缩实验结果(
Figure BDA0002753821900000081
n＝5，*P＜0.05，与对照组2比较)
Figure BDA0002753821900000082
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2的孔径为600μm，孔隙率为73％的骨小梁压缩试件和实施例1的未进行所述制备方法中步骤4)和步骤5)的孔径为600μm，孔隙率为73％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2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17.92MPa，显著高于对照组2(P＜0.05)，提示本发明含氧化层锆铌合金分区骨小梁单间室胫骨平台骨小梁部分抗压性能优异。
表2对照组2和实施例1的骨小梁试件抗压缩实验结果(
Figure BDA0002753821900000091
n＝5，*P＜0.05，与对照组2比较)
Figure BDA0002753821900000092
扫描电子显微镜(Crossbeam340/550，蔡司，德国)对实施例1所述含氧化层锆铌合金分区骨小梁单间室胫骨平台的锆铌合金基体与氧化层的横截面进行观察，(见图19)。并对实施例2、3含氧化层锆铌合金分区骨小梁单间室胫骨平台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，增强锆铌合金基体与氧化层之间的结合力。
XRD(D8DISCOVER，Bruker，德国)对实施例1含氧化层锆铌合金分区骨小梁单间室胫骨平台的氧化层进行分析(图20)，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的含氧化层锆铌合金分区骨小梁单间室胫骨平台进行显微硬度测量，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，提示本发明所述含氧化层锆铌合金分区骨小梁单间室胫骨平台的氧化层硬度高。实验证明，实施例2、3制备的含氧化层锆铌合金分区骨小梁单间室胫骨平台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制备的含氧化层锆铌合金分区骨小梁单间室胫骨平台相似。

Claims (3)

1.含氧化层锆铌合金分区骨小梁单间室胫骨平台的制备方法，其特征包括如下步骤：
1)以锆铌合金粉为原料，经3D打印一体成型得到含氧化层锆铌合金分区骨小梁单间室胫骨平台的第一中间产物，将所述第一中间产物放入热等静压炉，在惰性气体保护下，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，得到第二中间产物；
2)将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，得到第三中间产物；
3)将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；得第四中间产物；
4)将第四中间产物进行机加工修整、抛光、清洗和干燥，得第五中间产物，所述第五中间产物半胫骨平台托上表面的粗糙度Ra≤0.050μm；
5)将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％的常压惰性气体，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，得到含氧化层锆铌合金分区骨小梁单间室胫骨平台；
所述惰性气体为氦气或氩气；
所述含氧化层锆铌合金分区骨小梁单间室胫骨平台的结构，包括半胫骨平台托(1)，在所述半胫骨平台托的直线边的上表面设置有侧壁(2)，在所述半胫骨平台托的下表面近侧壁处设置有带有长圆孔的半椭圆形龙骨(3)，所述半胫骨平台托的下表面及带有长圆孔的半椭圆形龙骨表面设置有骨小梁，在半胫骨平台托的下表面除连接所述带有长圆孔的半椭圆形龙骨以外的其他部分设置的骨小梁分为前侧骨小梁(8)和后侧骨小梁(9)，所述前侧骨小梁(8)和后侧骨小梁(9)的分区线(6)垂直于所述侧壁(2)设置或与侧壁夹角(4)呈45°-70°设置；所述带有长圆孔的半椭圆形龙骨表面设置的骨小梁分为上部骨小梁(10)和下部骨小梁(11)，所述上部骨小梁和下部骨小梁的分区线为第二分区线(12)，第二分区线位于长圆孔顶下表面处或长圆孔底上表面处；
上部骨小梁(10)的孔径和孔隙率依次小于后侧骨小梁、前侧骨小梁和下部骨小梁；
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；
所述分区线(6)垂直于所述侧壁(2)设置，所述分区线(6)与侧壁(2)的交点(5)将侧壁分为侧壁前段(13)和侧壁后段(14)，侧壁前段(13)和侧壁后段(14)的比值为(2-3):1；
所述分区线(6)与侧壁夹角(4)呈45°-70°设置；分区线(6)与侧壁(2)的交点(5)位于侧壁中心；
所述上部骨小梁(10)的孔径为351μm-450μm，孔隙率为60％-65％；后侧骨小梁(9)的孔径为451μm-550μm，孔隙率为66％-70％；前侧骨小梁(8)的孔径为551μm-650μm，孔隙率为70％-75％；下部骨小梁(11)的孔径为651μm-750μm，孔隙率为76％-80％；
所述上部骨小梁(10)、后侧骨小梁(9)前侧骨小梁(8)和下部骨小梁(11)的厚度相等，为1mm-2mm。
2.根据权利要求1所述的方法，其特征是步骤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。
3.权利要求1或2的方法制备的含氧化层锆铌合金分区骨小梁单间室胫骨平台。
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