CN112315627B - 带有骨小梁的含氧化层锆铌合金胫骨平台假体及制备方法 - Google Patents

带有骨小梁的含氧化层锆铌合金胫骨平台假体及制备方法 Download PDF

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Publication number
CN112315627B
CN112315627B CN202011191009.7A CN202011191009A CN112315627B CN 112315627 B CN112315627 B CN 112315627B CN 202011191009 A CN202011191009 A CN 202011191009A CN 112315627 B CN112315627 B CN 112315627B
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China
Prior art keywords
bone
niobium alloy
shaped
intermediate product
kidney
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CN202011191009.7A
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CN112315627A (zh
Inventor
刘璐
曹雨
李建宇
张景康
周红秀
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Jiasite Medical Equipment Tianjin Co ltd
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Jiasite Medical Equipment Tianjin Co ltd
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Priority to CN202011191009.7A priority Critical patent/CN112315627B/zh
Publication of CN112315627A publication Critical patent/CN112315627A/zh
Priority to PCT/CN2021/101287 priority patent/WO2022088704A1/zh
Priority to US17/916,708 priority patent/US20230338615A1/en
Priority to EP21884445.4A priority patent/EP4094729A4/en
Priority to JP2022549958A priority patent/JP7413554B2/ja
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract

本发明公开了带有骨小梁的含氧化层锆铌合金胫骨平台假体及制备方法，该方法以锆铌合金粉为原料，经3D打印一体成型得到中间产物，再经热等静压、深冷和表面氧化，制备出包括近平台托骨小梁层和远平台托骨小梁层的胫骨平台假体，近平台托骨小梁层孔径和孔隙率均匀设置，远平台托骨小梁层孔径和孔隙率分区设置；本发明胫骨平台假体的骨小梁拓扑结构三个维度梯度分布，有限元模型64％‑72％区域的微应变在最低有效应变阈值和超生理应变阈值之间，增加假体力学适配性，具有优异骨长入性；其氧化层可一体化实现骨整合界面优良生物相容性和摩擦界面的超强耐磨性能、低磨损率。

Description

带有骨小梁的含氧化层锆铌合金胫骨平台假体及制备方法
技术领域
本发明涉及医用植入物材料技术领域，具体涉及带有骨小梁的含氧化层锆铌合金胫骨平台假体及制备方法。
背景技术
全膝关节置换术是目前临床上针对终末期膝关节疾患的有效治疗方式，其通过人工设计的关节假体替代损伤的膝关节组织，从而解除病患疼痛，恢复其膝关节功能，改善其生活质量。与人体解剖结构相对应，膝关节假体的组成包括股骨髁、胫骨平台及平台垫。随着医疗器械技术的飞速发展以及人们对假体产品安全与有效性要求的不断提高，膝关节假体设计和制造技术将需要不断的优化和提升。
目前，临床上应用的膝关节假体包括骨水泥型和生物型(非骨水泥固定)两大类。其中，骨水泥型假体依靠骨水泥的固化和填充，将关节假体与骨组织机械固定。但多年的临床应用发现，骨水泥固定可带来诸多安全与有效性问题：骨水泥单体聚合释放热量，造成周围组织损伤；骨水泥颗粒如果进入血液或在填充时引起髓腔高压，会导致肺栓塞和脂肪栓塞。
生物型膝关节假体可有效消除骨水泥带来的安全与有效性风险，通常利用表面多孔结构促进骨长入，获得长期稳定性。但其表面多孔结构通常采用喷砂、涂层、烧结等表面处理工艺制得，与实体结合强度低，易脱落，降低假体使用寿命。且这些多孔结构并不能实现有效骨长入，临床报道人工膝关节胫骨平台仅有2％～40％骨长入，无法形成有力的生物学固定。
专利CN109938888A通过EBM电子束熔融技术3D打印带有分区骨小梁结构胫骨平台，在人体下肢力线偏移，水平方向受力不均的情况下，通过不连续介质对力的传递能力不同，设计不同水平方向骨小梁分区拓扑结构，使得胫骨平台/骨界面应力/应变均一，从而实现均匀骨长入。但是从轴向考察平台/骨界面，骨小梁层为唯一过渡层。假体金属材质的高弹性模量与骨组织的低弹性模量间会发生应力遮挡。根据Wolff定律：应力只有使骨产生形变(又称微应变)后才能启动原始信号来调节骨的合成与分解代谢，且应变范围只有在最低有效应变阈值和超生理应变阈值之间才能促进骨生长。因此，设计一种膝关节胫骨平台假体，大幅减少应力遮挡，实现骨组织大部分区域微应变在最低有效应变阈值和超生理应变阈值之间，利于骨整合，具有重要意义。
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带有骨小梁的的含氧化层锆铌合金胫骨平台假体的报道。
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。因此，制备力学性能优异、同时实现两界面优点的带有骨小梁的含氧化层锆铌合金胫骨平台假体具有重要意义。
发明内容
本发明的主要目的在于克服现有技术不足，提供带有骨小梁的含氧化层锆铌合金胫骨平台假体。
本发明的第二个目的是提供带有骨小梁的含氧化层锆铌合金胫骨平台假体的制备方法。
本发明的技术方案概述如下：
带有骨小梁的含氧化层锆铌合金胫骨平台假体的制备方法，包括如下步骤：
1)以锆铌合金粉为原料，经3D打印一体成型得到带有骨小梁的含氧化层锆铌合金胫骨平台假体的第一中间产物，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，得到带有骨小梁的含氧化层锆铌合金胫骨平台假体；
带有骨小梁的含氧化层锆铌合金胫骨平台假体的第一中间产物、第二中间产物、第三中间产物、第四中间产物、第五中间产物与带有骨小梁的含氧化层锆铌合金胫骨平台假体的结构相同；
所述惰性气体为氦气或氩气；
所述带有骨小梁的含氧化层锆铌合金胫骨平台假体，包括肾形平台托1，在肾形平台托内向弯处的上表面设置有燕尾形凸块3，在燕尾形凸块3的两个斜向枝的外侧面设置有后凹槽5，在肾形平台托1与相对于燕尾形凸块3的外向弯处的上表面设置有弧形凸块2，在弧形凸块2的内侧面设置有前凹槽6，肾形平台托下表面的中部设置有柄4，肾形平台托下表面除连接柄4以外的其它部分设置有骨小梁9，骨小梁9由近平台托骨小梁层21和远平台托骨小梁层20组成；所述近平台托骨小梁层21的孔径和孔隙率均匀设置，远平台托骨小梁层呈三分区设置；相对应肾形平台托的横径10被第一标注点11和第二标注点12划分为第一段25、第二段26和第三段27，第一段、第二段和第三段的长依次为肾形平台托横径的25％-38％:24％-50％:25％-38％，第一分区线13过第一标注点11，第二分区线15过第二标注点12；第一分区线13和第二分区线14为直线或弧线，并将相对应肾形平台托的远平台托骨小梁层20划分为内侧区15、中间区16和外侧区17；内侧区15骨小梁的孔径和孔隙率依次大于外侧区17和中间区16骨小梁的孔径和孔隙率。
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45-150μm。
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。
近平台托骨小梁层21的骨小梁孔径为0.36mm-0.50mm，孔隙率为55％–65％，通孔率为100％；厚度为0.2mm-1mm。
远平台托骨小梁层20的第一分区线13和第二分区线14为直线时呈平行设置或呈八字形设置；第一分区线13与肾形平台托横径10的夹角18的度数为100°-60°，第二分区线14与肾形平台托横径10的夹角19的度数为80°-120°。
远平台托骨小梁层(20)的内侧区骨小梁的孔径为1.00mm-1.10mm，孔隙率为77.6％–85％，通孔率为100％；中间区骨小梁孔径为0.74mm-0.85mm，孔隙率为70.0％-74.7％，通孔率为100％；外侧区骨小梁孔径为0.86mm-0.99mm，孔隙率为74.8％-77.5％，通孔率为100％；厚度为0.5mm-3mm。
柄为连接有支撑板的变径管、连接有支撑板的底部封闭的变径管、十字形筋板或弯曲十字形筋板。
上述方法制备的带有骨小梁的含氧化层锆铌合金胫骨平台假体。
与现有技术方案相比，本发明具有以下有益效果：
本发明带有骨小梁的含氧化层锆铌合金胫骨平台假体的骨小梁拓扑结构从三个维度上梯度分布，可提高胫骨平台骨小梁与实体的结合强度和实现胫骨平台骨组织有限元模型64％-72％区域的微应变在最低有效应变阈值和超生理应变阈值之间，增加假体力学适配性，具有优异骨长入性。
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。
本发明制得的所述带有骨小梁的含氧化层锆铌合金胫骨平台假体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。
本发明所述带有骨小梁的含氧化层锆铌合金胫骨平台假体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。
本发明所述带有骨小梁的含氧化层锆铌合金胫骨平台假体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。
本发明所述带有骨小梁的含氧化层锆铌合金胫骨平台假体低伪影，对核磁干扰小，可进行核磁检测。
附图说明
图1为本发明带有骨小梁的含氧化层锆铌合金胫骨平台假体(柄为弯曲十字形筋板)轴测图。
图2为本发明带有骨小梁的含氧化层锆铌合金胫骨平台假体下表面骨小梁分区划分示意图。
图3为本发明带有骨小梁的含氧化层锆铌合金胫骨平台假体(柄为弯曲十字形筋板)仰视图。
图4为本发明带有骨小梁的含氧化层锆铌合金胫骨平台假体(第一分区线13和第二分区线14为弧线)仰视图。
图5为本发明带有骨小梁的含氧化层锆铌合金胫骨平台假体(第一分区线13和第二分区线14为直线呈八字形设置)仰视图。
图6为本发明带有骨小梁的含氧化层锆铌合金胫骨平台假体(柄为底部封闭的变径管)轴测图。
图7为本发明带有骨小梁的含氧化层锆铌合金胫骨平台假体(柄为底部封闭的变径管、肾形平台托和骨小梁层局剖)轴测图。
图8为本发明带有骨小梁的含氧化层锆铌合金胫骨平台假体(柄为连接有支撑板的底部封闭的变径管)轴测图(不包括远平台骨小梁层)。
图9为本发明带有骨小梁的含氧化层锆铌合金胫骨平台假体(柄为连接有支撑板的变径管)轴测图。
图10为实施例1的带有骨小梁的含氧化层锆铌合金胫骨平台假体(柄为弯曲十字形筋板)第一分区线13和第二分区线14为直线平行且与横径(胫骨平台的长)的夹角为90度时有限元分析应变云图。
图11为实施例2的带有骨小梁的含氧化层锆铌合金胫骨平台假体(柄为连接有支撑板的底部封闭的变径管)第一分区线13和第二分区线14为直线呈八字形有限元分析应变云图。
图12为实施例3的带有骨小梁的含氧化层锆铌合金胫骨平台假体(柄为连接有支撑板的底部封闭的变径管)第一分区线13和第二分区线14呈弧线有限元分析应变云图。
图13为对照组1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14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15为对照组1的骨小梁部分SEM图。
图16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17为实施例1的氧化层与基体的横截面SEM图。
图18为实施例1的氧化层表面的XRD曲线。
图19为实施例1的带有骨小梁的含氧化层锆铌合金胫骨平台假体(柄为弯曲十字形筋板)第一分区线13和第二分区线14为直线平行且与横径(胫骨平台的长)的夹角为90度时等效应力云图。
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
带有骨小梁的含氧化层锆铌合金胫骨平台假体的制备方法，包括如下步骤：
1)以锆铌合金粉为原料，经3D打印一体成型得到带有骨小梁的含氧化层锆铌合金胫骨平台假体的第一中间产物，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，得到带有骨小梁的含氧化层锆铌合金胫骨平台假体；
带有骨小梁的含氧化层锆铌合金胫骨平台假体的第一中间产物、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带有骨小梁的含氧化层锆铌合金胫骨平台假体的结构相同。
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。
带有骨小梁的含氧化层锆铌合金胫骨平台假体(见图1)，包括肾形平台托1，在肾形平台托内向弯处的上表面设置有燕尾形凸块3，在燕尾形凸块3的两个斜向枝的外侧面设置有后凹槽5，在肾形平台托1与相对于燕尾形凸块3的外向弯处的上表面设置有弧形凸块2，在弧形凸块2的内侧面设置有前凹槽6，肾形平台托下表面的中部设置有柄4，肾形平台托下表面除连接柄4以外的其它部分设置有骨小梁9，骨小梁9由近平台托骨小梁层21和远平台托骨小梁层20组成(见图7)；所述近平台托骨小梁层21的孔径和孔隙率均匀设置(见图8)，远平台托骨小梁层呈三分区设置；相对应肾形平台托的横径10被第一标注点11和第二标注点12划分为第一段25、第二段26和第三段27，第一段、第二段和第三段的长依次为肾形平台托横径的30％:40％:30％，第一分区线13过第一标注点11，第二分区线14过第二标注点12；第一分区线13和第二分区线14为直线或弧线，并将相对应肾形平台托的远平台托骨小梁层20划分为内侧区15、中间区16和外侧区17(见图2)；
所述近平台托骨小梁层21的骨小梁孔径为0.43mm，孔隙率为60％，通孔率为100％；厚度为0.6mm。
远平台托骨小梁层20的第一分区线13和第二分区线14为直线时呈平行设置；第一分区线13与肾形平台托横径10的夹角18的度数为90°(见图3)，第二分区线14与肾形平台托横径10的夹角19的度数为90°。
远平台托骨小梁层20的内侧区骨小梁的孔径为1.05mm，孔隙率为80％，通孔率为100％；中间区骨小梁孔径为0.80mm，孔隙率为72％，通孔率为100％；外侧区骨小梁孔径为0.90mm，孔隙率为75％，通孔率为100％；厚度为2mm。
所述柄为弯曲十字形筋板(见图3)。
本实施例的有限元分析应变云图(见图10)。还可以在肾形平台托下表面的边缘设置侧壁22，使骨小梁层设置在侧壁以内见图7。
实施例2
带有骨小梁的含氧化层锆铌合金胫骨平台假体的制备方法，包括如下步骤：
1)以锆铌合金粉为原料，经3D打印一体成型得到带有骨小梁的含氧化层锆铌合金胫骨平台假体的第一中间产物，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，得到带有骨小梁的含氧化层锆铌合金胫骨平台假体；
带有骨小梁的含氧化层锆铌合金胫骨平台假体的第一中间产物、第二中间产物、第三中间产物、第四中间产物、第五中间产物与带有骨小梁的含氧化层锆铌合金胫骨平台假体的结构相同；
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；
带有骨小梁的含氧化层锆铌合金胫骨平台假体(见图9)，包括肾形平台托1，在肾形平台托内向弯处的上表面设置有燕尾形凸块3，在燕尾形凸块3的两个斜向枝的外侧面设置有后凹槽5，在肾形平台托1与相对于燕尾形凸块3的外向弯处的上表面设置有弧形凸块2，在弧形凸块2的内侧面设置有前凹槽6，肾形平台托下表面的中部设置有柄4，肾形平台托下表面除连接柄4以外的其它部分设置有骨小梁9，骨小梁9由近平台托骨小梁层21和远平台托骨小梁层20组成；所述近平台托骨小梁层21的孔径和孔隙率均匀设置，远平台托骨小梁层呈三分区设置；相对应肾形平台托的横径10被第一标注点11和第二标注点12划分为第一段25、第二段26和第三段27，第一段、第二段和第三段的长依次为肾形平台托横径的38％:24％:38％，第一分区线13过第一标注点11，第二分区线14过第二标注点12；第一分区线13和第二分区线14为直线，并将相对应肾形平台托的远平台托骨小梁层20划分为内侧区15、中间区16和外侧区17；
所述近平台托骨小梁层21的骨小梁孔径为0.50mm，孔隙率为65％，通孔率为100％；所述近平台托骨小梁层21厚度为1mm。
所述远平台托骨小梁层20的第一分区线13和第二分区线14为直线时呈八字形设置；第一分区线13与肾形平台托横径10的夹角18的度数为100°，第二分区线14与肾形平台托横径10的夹角19的度数为80°。(除柄以外，远平台托骨小梁层见图5)
所述远平台托骨小梁层20的内侧区骨小梁的孔径为1.10mm，孔隙率为85％，通孔率为100％；中间区骨小梁孔径为0.85mm，孔隙率为74.7％，通孔率为100％；外侧区骨小梁孔径为0.99mm，孔隙率为77.5％，通孔率为100％；所述远平台托骨小梁层20厚度为0.5mm。
柄为连接有支撑板的底部封闭的变径管(柄参见图6)。
本实施例的有限元分析应变云图见图11。
实施例3
1.带有骨小梁的含氧化层锆铌合金胫骨平台假体的制备方法，包括如下步骤：
(1)以锆铌合金粉为原料，经3D打印一体成型得到带有骨小梁的含氧化层锆铌合金胫骨平台假体第一中间产物，将所述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，得到带有骨小梁的含氧化层锆铌合金胫骨平台假体；
带有骨小梁的含氧化层锆铌合金胫骨平台假体的第一中间产物、第二中间产物、第三中间产物、第四中间产物、第五中间产物与带有骨小梁的含氧化层锆铌合金胫骨平台假体的结构相同；
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；
带有骨小梁的含氧化层锆铌合金胫骨平台假体，包括肾形平台托1，在肾形平台托内向弯处的上表面设置有燕尾形凸块3，在燕尾形凸块3的两个斜向枝的外侧面设置有后凹槽5，在肾形平台托1与相对于燕尾形凸块3的外向弯处的上表面设置有弧形凸块2，在弧形凸块2的内侧面设置有前凹槽6，肾形平台托下表面的中部设置有柄4，肾形平台托下表面除连接柄4以外的其它部分设置有骨小梁9，骨小梁9由近平台托骨小梁层21和远平台托骨小梁层20组成；所述近平台托骨小梁层21的孔径和孔隙率均匀设置，远平台托骨小梁层呈三分区设置；相对应肾形平台托的横径10被第一标注点11和第二标注点12划分为第一段25、第二段26和第三段27，第一段、第二段和第三段的长依次为肾形平台托横径的25％-:50％:25％，第一分区线13过第一标注点11，第二分区线14过第二标注点12；第一分区线13和第二分区线14为弧线(见图4)，并将相对应肾形平台托的远平台托骨小梁层20划分为内侧区15、中间区16和外侧区17；
近平台托骨小梁层21的骨小梁孔径为0.36mm，孔隙率为55％，通孔率为100％；厚度为0.2mm。
所述远平台托骨小梁层20的内侧区骨小梁的孔径为1.00mm，孔隙率为77.6％，通孔率为100％；中间区骨小梁孔径为0.74mm，孔隙率为70.0％，通孔率为100％；外侧区骨小梁孔径为0.86mm，孔隙率为74.8％，通孔率为100％；所述远平台托骨小梁层20厚度为3mm。
柄为连接有支撑板的底部封闭的变径管。
本实施例的有限元分析应变云图见图12。
还可以在肾形平台托下表面的边缘设置侧壁22，使骨小梁层设置在侧壁以内。
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的胫骨平台假体。
实验验证：
将实施例1、2、3的有限元模型进行有限元分析，得到的有限元分析应变云图只显示范围为1000-3000的微应变(阴影部分)，实施例1-实施例3在胫骨平台骨组织有限元模型上1000-3000微应变区域在整个胫骨平台骨组织有限元模型的占比分别为65.6％、64.4％和68.1％(图10、11、12)，提示本发明所述带有骨小梁的含氧化层锆铌合金胫骨平台假体可实现骨组织大部分区域微应变在最低有效应变阈值和超生理应变阈值之间，利于骨长入。
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13和14所示，对照组1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，本发明所述带有骨小梁的含氧化层锆铌合金胫骨平台假体的实体部分(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15-16所示，与对照组1相比，实施例1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1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)，提示本发明制得的带有骨小梁的含氧化层锆铌合金胫骨平台假体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(n＝5，*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)，提示本发明制得的带有骨小梁的含氧化层锆铌合金胫骨平台假体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(n＝5，*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所述带有骨小梁的含氧化层锆铌合金胫骨平台假体的锆铌合金基体与氧化层的横截面进行观察，(见图17)。并对实施例2、3带有骨小梁的含氧化层锆铌合金胫骨平台假体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(D8 DISCOVER，Bruker，德国)对实施例1的带有骨小梁的含氧化层锆铌合金胫骨平台假体的氧化层进行分析(图18)，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的带有骨小梁的含氧化层锆铌合金胫骨平台假体进行显微硬度测量，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，提示本发明所述带有骨小梁的含氧化层锆铌合金胫骨平台假体的氧化层硬度高。
实验证明，实施例2、3制备的带有骨小梁的含氧化层锆铌合金胫骨平台假体的骨小梁部分的锆铌合金粉熔结程度、抗压性能，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制备的带有骨小梁的含氧化层锆铌合金胫骨平台假体相似。
实施例1的有限元模型进行有限元分析，结果如图19所示，实施例1的带有骨小梁的含氧化层锆铌合金胫骨平台假体的骨小梁与实体连接部位的应力集中区域小，提示本发明带有骨小梁的含氧化层锆铌合金胫骨平台假体的骨小梁与实体的结合强度优异。

Claims (2)

1.带有骨小梁的含氧化层锆铌合金胫骨平台假体的制备方法，包括如下步骤：
1）以锆铌合金粉为原料，经3D打印一体成型得到带有骨小梁的含氧化层锆铌合金胫骨平台假体的第一中间产物，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，得到带有骨小梁的含氧化层锆铌合金胫骨平台假体；
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；
所述带有骨小梁的含氧化层锆铌合金胫骨平台假体，包括肾形平台托（1）在肾形平台托内向弯处的上表面设置有燕尾形凸块（3），在燕尾形凸块（3）的两个斜向枝的外侧面设置有后凹槽（5），在肾形平台托（1）与相对于燕尾形凸块（3）的外向弯处的上表面设置有弧形凸块（2），在弧形凸块（2）的内侧面设置有前凹槽（6），肾形平台托下表面的中部设置有柄（4），肾形平台托下表面除连接柄（4）以外的其它部分设置有骨小梁（9），骨小梁（9）由近平台托骨小梁层（21）和远平台托骨小梁层（20）组成；所述近平台托骨小梁层（21）的孔径和孔隙率均匀设置，远平台托骨小梁层呈三分区设置；相对应肾形平台托的横径（10）被第一标注点（11）和第二标注点（12）划分为第一段（25）、第二段（26）和第三段（27），第一段、第二段和第三段的长依次为肾形平台托横径的30% :40% : 30%，第一分区线（13）过第一标注点（11），第二分区线（14）过第二标注点（12）；第一分区线（13）和第二分区线（14）为直线或弧线，并将相对应肾形平台托的远平台托骨小梁层（20）划分为内侧区（15）、中间区（16）和外侧区（17）；
所述近平台托骨小梁层（21）的骨小梁孔径为0.43 mm，孔隙率为60%，通孔率为100%；厚度为0.6mm；
远平台托骨小梁层（20）的第一分区线（13）和第二分区线（14）为直线时呈平行设置；第一分区线（13）与肾形平台托横径（10）的夹角（18）的度数为90°，第二分区线（14）与肾形平台托横径（10）的夹角（19）的度数为90°；
远平台托骨小梁层（20）的内侧区骨小梁的孔径为1.05mm，孔隙率为80%，通孔率为100%；中间区骨小梁孔径为0.80mm，孔隙率为72%，通孔率为100%；外侧区骨小梁孔径为0.90mm，孔隙率为75%，通孔率为100%；厚度为2mm；
所述柄为弯曲十字形筋板。
2.权利要求1的方法制备的带有骨小梁的含氧化层锆铌合金胫骨平台假体。
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