CN111449808A - 一种增材制造多孔钽金属髋臼外杯及其制备方法 - Google Patents
一种增材制造多孔钽金属髋臼外杯及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种增材制造多孔钽金属髋臼外杯及其制备方法,多孔钽髋臼外杯50%以上体积为多孔结构,平均孔径200~2000μm,平均丝径300~1000μm,孔隙率50~95%,孔道连通性大于80%,多孔结构贯穿整个半球壳杯体,厚度大于3mm,并有1个以上螺孔;以纯钽金属或钽合金粉体为原料通过粉末床激光熔融或电子束熔融等增材制造技术一体化制备而成,原料粉体粒径10~150μm;该多孔钽髋臼外杯杯口为致密结构,厚度大于1mm,其内侧均匀分布有3个以上卡槽。本发明技术优势为:钽金属杯体多孔结构力学性能接近于人骨且有利于快速骨长入,形成生物固定,提高植入稳定性。
Description
技术领域
本发明涉及生物医用金属材料和医疗器械技术领域,具体为一种增材制造多孔钽金属髋臼外杯及其制备方法。
背景技术
髋关节是人体最大的承重关节,当髋关节因退化、病变或外伤导致疼痛、僵硬或变形,甚至行动不便,无法以药物或其他治疗方法缓解症状时,通常会以手术的方式植入人工髋关节假体,使患者恢复髋关节正常生理功能。人工全髋关节置换可以很好地缓解疼痛,改善关节功能,恢复关节的稳定和肢体的功能,已经得到广大患者和骨科医生的认同。髋臼外杯作为人工全髋关节假体的关键组配件之一,其综合力学性能与人骨的匹配性和骨融合/骨长入性能对假体早期稳定性、长期稳定性和使用寿命具有重要影响。传统工艺制备的金属髋臼外杯为致密结构,强度和模量过高,与人骨力学性能不匹配,容易产生应力屏蔽,使得髋臼周围骨溶解,造成关节假体松动失效,使用寿命大大缩短。致密结构表面骨融合性能较差,髋臼外杯植入早期稳定性主要靠螺钉机械固定,由于没有骨长入,不能形成生物固定,其长期稳定性不足,容易出现无菌松动,造成关节假体失效。
为了解决上述问题,通过物理或化学方法,采用表面处理和喷涂技术能够在金属髋臼外杯表面获得骨融合性更好的致密涂层或颗粒堆积多孔涂层,比如钛珠涂层、生物陶瓷/玻璃涂层等,或者表面粗糙化,比如形成沟壑表面或点坑表面等。涂层骨融合和骨长入性能有提高,但是存在与金属髋臼外杯基体脱层剥落的问题,造成假体松动。表面粗糙化处理的金属髋臼外杯虽然骨融合性能有所提高,但是粗糙处理层厚有限,骨长入不明显,而且仍然存在强度和模量过高的问题,关节假体使用寿命远低于预期。
增材制造能够实现多孔结构和致密结构一体化制备,并且多孔结构能够精确设计和调控,是制备新型结构-功能一体化植入性医疗器械的新的技术途径。本发明提出一种增材制造多孔钽金属髋臼外杯及其制备方法。所述技术髋臼外杯杯体具有一体化多孔结构,与表面处理和喷涂技术制备的粗糙化表面和涂层多孔结构相比,其优势在于增材制造的多孔结构贯穿整个髋臼外杯杯体厚度,并且具有更高的孔隙率、孔道连通性、理想的孔径和丝径范围,可显著提高骨融合,尤其是骨长入性能,通过高强度的生物固定,增强早期稳定性和中长期稳定性,延长关节假体的使用寿命。与钛及钛合金相比,多孔钽金属强度和抗疲劳性能更好,模量更低,与人骨力学性能更匹配,可避免应力遮挡造成骨溶解的问题,并且钽的生物相容性和骨融合性能更好。本发明所述增材制造多孔钽金属髋臼外杯不仅可以作为人工髋关节假体组配件应用于普通患者初次置换,也适用于髋关节周围骨质疏松或骨质量较差的患者以及关节初次置换假体失效需要翻修的患者等,解决临床重大需求。
发明内容
本发明的目的在于提供一种增材制造多孔钽金属髋臼外杯及其制作方法,利用增材制造的高设计自由度,精确控制多孔结构特征,以提高髋臼杯的初始植入稳定性,并促进骨长入与骨融合。
为了实现上述发明目的,本发明提供以下技术方案:
一种增材制造多孔钽金属髋臼外杯,其特征在于:它为髋臼外杯由多孔结构半球壳杯体和致密结构杯口组成的一体结构,且由纯钽金属或含钽合金粉末作为原料通过增材制造技术制成。
进一步地,上述的增材制造多孔钽金属髋臼外杯,其特征在于:所述的髋臼外杯50%以上体积为多孔结构,平均孔径200~2000μm,平均丝径300~1000μm,孔隙率50~95 %,孔道连通性大于80%;多孔结构贯穿整个半球壳杯体,厚度大于3mm;并多孔结构表面设有1个以上贯通螺孔,螺孔内壁为致密层,厚度小于2mm;杯体外径大于40mm,小于65mm,杯体高度大于20mm。
进一步地,上述的增材制造多孔钽金属髋臼外杯,其特征在于:所述的多孔结构半球壳杯体为仿生骨小梁多孔结构或规则多孔结构。
其中多孔结构平均丝径300~1000μm,优选为300~800μm,进一步优选为300~600μm;平均孔径200~2000μm,优选为300~1500μm,进一步优选为300~1000μm;孔隙率50~95%,优选为60~85%,进一步优选为65~80%;孔道连通性大于80%,优选为大于90%,进一步优选为大于95%。
进一步地,上述的增材制造多孔钽金属髋臼外杯,其特征在于:所述的致密结构杯口外侧高度大于1mm,内侧高度大于5mm,杯口内侧均匀分布有3个以上自锁卡槽。
所述致密结构杯口部分和多孔结构杯体厚度一致,厚度不小于4mm。
所述髋臼外杯杯体外径大于40mm,小于65m,杯体高度大于20mm。
所述自锁卡槽为圆柱形,直径为3mm,深度为1mm。
一种增材制造多孔钽金属髋臼外杯的制备方法,其特征在于,其方法为:采用粒径10~150μm的纯钽金属或含钽合金粉体原料,运用增材制造技术,包括粉末床激光熔融和粉末床电子束熔融技术等,再进行后处理后工艺制备成多孔结构的钽金属髋臼外杯。
上述的增材制造多孔钽金属髋臼外杯的制备方法,其特征在于,具体方法为:利用建模软件构建髋臼外杯的三维模型,包括外部形状和内部孔道结构,将所述三维模型转换为打印设备所需格式并导入到设备中;采用纯钽金属或含钽合金粉体原料,用增材制造技术成型,主要包括粉末床激光熔融和粉末床电子束熔融技术,再进行后处理工艺,后处理具体工艺包括清粉、线切割、去支撑、喷砂、超声清洗和热处理。
上述的增材制造多孔钽金属髋臼外杯的制备方法,其特征在于:所述的粉末床激光熔融主要工艺参数为:激光功率100~500w,扫描速度100~600mm/s,扫描线间距0.05~0.15mm,切片层厚20~50μm,基板温度50~300℃。
上述的增材制造多孔钽金属髋臼外杯的制备方法,其特征在于:所述的粉末床电子束熔融主要工艺参数为:预热温度750~1500℃,扫描电流2~20mA,扫描速度1.0×104 ~1.0×106mm/s,切片层厚为20~100μm。
上述的增材制造多孔钽金属髋臼外杯的制备方法,其特征在于:所述的清粉工艺为物理方式清粉,具体包括使用湿式防爆吸尘器吸除和压缩空气喷吹。
上述的增材制造多孔钽金属髋臼外杯的制备方法,其特征在于:所述的喷砂工艺使用的是60~3200目的非金属砂。
上述的增材制造多孔钽金属髋臼外杯的制备方法,其特征在于:所述的超声波清洗选择溶剂依次为丙酮、无水乙醇和蒸馏水,清洗次数大于10次,总清洗时间大于5h。
上述的增材制造多孔钽金属髋臼外杯的制备方法,其特征在于:所述的热处理工艺为真空退火处理,消除热应力;退火温度为800~1100℃,真空度<5×10-3Pa,保温时间2~6h。
所述超声波清洗溶剂选择依次为丙酮、无水乙醇、蒸馏水,清洗次数大于10次,优选为大于15次,进一步优选为大于20次;总清洗时间大于5h,优选为大于8h,进一步优选为大于10h。
所述喷砂步骤使用的是非金属砂,粒径为60~3200目,优选为60~2000目,进一步优选为100~500目。
所述热处理为真空去应力退火处理;退火温度为800~1100℃,真空度<5×10-3Pa,保温时间2~6h。
本发明的有益效果是:本发明提供的增材制造多孔钽金属髋臼外杯,其高孔隙率可以使其与人体骨组织更好的融合,增强初始植入稳定性,并促进骨再生与骨生长;多孔结构的形态利用增材制造工艺有非常高的可控性,从而使植入体具有跟人骨相似的力学特性,有效的减小力学屏蔽效应。多孔钽金属材料的耐压强度可达到50MPa以上,抗弯强度可达到100MPa以上,弹性模量1~5GPa。经工业CT检测,髋臼杯整体多孔结构与设计基本一致,孔道连通性在95%以上。动物实验表明,术后一个月植入体推出剪切固定强度大于15MPa,术后三个月新生骨填充体积比高于60%。
附图说明
图1为本发明实施例1仿生骨小梁多孔结构髋臼外杯正视结构示意图。
图2为图1的纵截面视图。
图3为本发明实施例1仿生骨小梁多孔结构髋臼外杯的成品照片。
图4为本发明实施例1仿生骨小梁多孔结构髋臼外杯的三维建模图以及局部放大图。
图5为本发明实施例2菱形十二面体多孔结构髋臼外杯正视结构示意图。
图6为图5的纵截面视图。
图7为本发明实施例2菱形十二面体多孔结构髋臼外杯成品照片。
图8为本发明实施例2菱形十二面体多孔结构髋臼外杯三维建模图以及局部放大图。
在图中,1、多孔结构半球壳杯体,2、致密结构杯口,3、贯通螺孔,4、卡槽。
具体实施方式
下面结合实施例对本发明的技术方案进一步说明:
实施例1 仿生骨小梁多孔结构髋臼外杯
如图1-4所示,本实施例髋臼外杯由致密结构杯口2和仿生骨小梁多孔结构半球壳杯体1组成,其中多孔结构平均丝径为298μm,平均孔径878μm;孔隙率75.1%,孔道连通性为99%。杯口部分外侧高度为1mm,内侧高度为5mm;杯口内侧沿圆周均匀分布10个圆柱形卡槽4,卡槽直径3mm,深度1mm;多孔结构半球壳杯体设有7个贯通螺孔3,螺孔内壁为致密层,厚度为1mm;螺孔直径为5mm。
所述仿生骨小梁多孔结构髋臼外杯的制作步骤如下:
利用建模软件构建上述仿生骨小梁多孔结构髋臼外杯的三维模型,将所述三维模型转换为打印设备所需格式并导入到设备中;利用纯钽金属粉末材料进行打印,得到所述髋臼外杯。
将上述髋臼杯进行一系列后处理加工,具体包括清粉,线切割,去支撑,喷砂,超声清洗,热处理等。
所述金属增材制造设备为粉末床激光熔融设备。
所述纯钽金属粉末材料为正球形,球形度大于90%,粒径为15~45μm。
所述主要打印工艺参数为:激光功率250w;扫描速度150mm/s;扫描线间距0.07mm;切片层厚0.03mm;基板温度100℃。
所述清粉操作为物理方式清粉,具体包括使用湿式防爆吸尘器吸除,压缩空气喷吹以及超声波清洗。
所述超声波清洗溶剂选择依次为丙酮、无水乙醇、蒸馏水,清洗总次数为20次,总清洗时间10h。
所述喷砂步骤使用的是100目的非金属砂。
所述热处理为真空去应力退火处理,退火温度为1000℃,真空度<5×10-3Pa,保温时间2h。
实施例2 菱形十二面体多孔结构髋臼外杯
如图5-8所示,本实施例的髋臼外杯由菱形十二面体多孔结构半球壳杯体1组成,其中多孔结构平均丝径为413μm,平均孔径835μm;孔隙率70%,孔道连通性为99%。多孔结构半球壳杯体设有4个贯通螺孔3,螺孔内壁为致密层,厚度为1mm;螺孔直径为5mm。
所述菱形十二面体多孔结构髋臼外杯的制作步骤如下:
利用建模软件构建上述仿生骨小梁多孔结构髋臼外杯的三维模型,将所述三维模型转换为打印设备所需格式并导入到设备中;利用纯钽金属粉末原料进行打印,得到所述髋臼外杯。
将上述髋臼杯进行一系列后处理加工,具体包括清粉,线切割,去支撑,喷砂,超声清洗,热处理等。
所述金属增材制造设备为粉末床电子束熔融设备。
所述纯钽金属粉末原料为球形粉,球形度大于80%,粒径为 53~105μm 。
所述主要打印工艺参数为:预热温度1000℃,扫描电流10mA,扫描速度1.0×105mm/s,切片层厚为50μm。
所述清粉操作为物理方式清粉,具体包括使用湿式防爆吸尘器吸除,压缩空气喷吹以及超声波清洗。
所述超声波清洗溶剂选择依次为丙酮、无水乙醇、蒸馏水,清洗次数大于10次,总清洗时间大于10h。
所述喷砂步骤使用的是100目的非金属砂。
所述热处理为真空去应力退火处理,退火温度为1000℃,真空度<5×10-3Pa,保温时间1h。
以上所述是本发明的优选实施例,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也视为本发明的保护范围。
Claims (12)
1.一种增材制造多孔钽金属髋臼外杯,其特征在于:它为髋臼外杯由多孔结构半球壳杯体和致密结构杯口组成的一体结构,且由纯钽金属或含钽合金粉末作为原料通过增材制造技术制成。
2.根据权利要求1所述的增材制造多孔钽金属髋臼外杯,其特征在于:所述的髋臼外杯50%以上体积为多孔结构,平均孔径200~2000μm,平均丝径300~1000μm,孔隙率50~95 %,孔道连通性大于80%;多孔结构贯穿整个半球壳杯体,厚度大于3mm;并多孔结构表面设有1个以上贯通螺孔,螺孔内壁为致密层,厚度小于2mm;杯体外径大于40mm,小于65mm,杯体高度大于20mm。
3.根据权利要求1所述的增材制造多孔钽金属髋臼外杯,其特征在于:所述的多孔结构半球壳杯体为仿生骨小梁多孔结构或规则多孔结构。
4.根据权利要求1所述的增材制造多孔钽金属髋臼外杯,其特征在于:所述的致密结构杯口外侧高度大于1mm,内侧高度大于5mm,杯口内侧均匀分布有3个以上自锁卡槽。
5.一种增材制造多孔钽金属髋臼外杯的制备方法,其特征在于,其方法为:采用粒径10~150μm的纯钽金属或含钽合金粉体原料,运用增材制造技术,包括粉末床激光熔融和电子束熔融技术,再进行后处理后工艺制备成多孔结构的钽金属髋臼外杯。
6.根据权利要求5所述的增材制造多孔钽金属髋臼外杯的制备方法,其特征在于,具体方法为:利用建模软件构建髋臼外杯的三维模型,包括外部形状和内部孔道结构,将所述三维模型转换为打印设备所需格式并导入到设备中;采用纯钽金属或含钽合金粉体原料,用增材制造技术成型,主要包括粉末床激光熔融和粉末床电子束熔融技术,再进行后处理工艺,后处理具体工艺包括清粉、线切割、去支撑、喷砂、超声清洗和热处理。
7.根据权利要求5或6所述的增材制造多孔钽金属髋臼外杯的制备方法,其特征在于:所述的粉末床激光熔融主要工艺参数为:激光功率100~500w,扫描速度100~600mm/s,扫描线间距0.05~0.15mm,切片层厚20~50μm,基板温度50~300℃。
8.根据权利要求5或6所述的增材制造多孔钽金属髋臼外杯的制备方法,其特征在于:所述的粉末床电子束熔融主要工艺参数为:预热温度750~1500℃,扫描电流2~20mA,扫描速度1.0×104 ~1.0×106mm/s,切片层厚为20~100μm。
9.根据权利要求6所述的增材制造多孔钽金属髋臼外杯的制备方法,其特征在于:所述的清粉工艺为物理方式清粉,具体包括使用湿式防爆吸尘器吸除和压缩空气喷吹。
10.根据权利要求6所述的增材制造多孔钽金属髋臼外杯的制备方法,其特征在于:所述喷砂工艺使用的是60~3200目的非金属砂。
11.根据权利要求6所述的增材制造多孔钽金属髋臼外杯的制备方法,其特征在于:所述的超声波清洗选择溶剂依次为丙酮、无水乙醇和蒸馏水,清洗次数大于10次,总清洗时间大于5h。
12.根据权利要求6所述的增材制造多孔钽金属髋臼外杯的制备方法,其特征在于:所述的热处理为真空退火处理,消除热应力;退火温度为800~1100℃,真空度<5×10-3Pa,保温时间2~6h。
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