CN112168431A - 一种功能仿生性多孔钛合金股骨头支撑棒及其制备方法 - Google Patents
一种功能仿生性多孔钛合金股骨头支撑棒及其制备方法 Download PDFInfo
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Abstract
本发明属医用骨修复材料及其制备领域,涉及一种功能仿生性多孔钛合金股骨头支撑棒及其制备方法。其组分包括:钛合金与镁。其制备包括:采用电子束熔融(EBM)技术,以钛合金为原材料制备与人体骨力学强度和弹性模量相匹配、且具有骨小梁仿生多孔结构的股骨头支撑棒,继而采用多弧离子镀膜技术在多孔钛合金内外表面制备高纯度功能性镁涂层。值得强调的是,本材料由于其具有良好的力学强度,较好的血管形成效应及促成骨效应,故可用于股骨头支撑棒及其它部位骨修复材料的制备。本材料制备方法简便易行,对人体环境友好,可批量生产,在医用骨修复材料领域应用前景良好。
Description
技术领域
本发明属于医学骨修复材料及其制备领域,具体涉及一种功能仿生性多孔钛合金股骨头支撑棒及其制备方法。
背景技术
股骨头坏死基本病理生理为微循环与骨再生障碍。因此,在对其进行保头治疗时需要一种既满足力学支撑,又具有改善循环和骨再生能力的功能性骨修复材料,用于髓芯减压后骨缺损部位的填充,从而提高股骨头坏死的保头治疗效果。
多孔钛合金因保留了较好的机械强度,同时具有较低的表观弹性模量和可供骨与血管长入的多孔特征,成为骨修复替代产品研发的优势材料,受到研究者的青睐。但多孔钛合金仍然是一种生物惰性材料,其孔隙内部缺乏有效的促骨长入活性,导致深部骨长入困难,并且不具备血管再生的能力,使其应用效果仍不理想。
镁金属由于其可降解性和降解产物产生的多重生物学效应而被认为是一种革命性的金属材料。大量研究表明,镁金属体内降解产物没有细胞毒性,降解生成的镁离子具有促进新骨形成和诱导血管再生的双重活性,但是镁金属抗腐蚀性差、力学强度不足等缺陷,又限制了其作为一种单一材料在骨替代修复领域的应用。
因此,有必要根据股骨头坏死的病理生理学机制,将多孔钛合金的优良的力学性能和镁金属生物活性有机结合,设计一种功能仿生支架修复材料,通过调控多孔钛合金孔隙结构和镁涂层的降解速度,既实现有效力学支撑防止股骨头塌陷,又利用镁金属生物活性改善局部骨再生和血管形成环境,从而为股骨头坏死的治疗提供有效的解决方案,为髓芯减压后的填充修复提供满足股骨头坏死修复多种生物活性需求的理想新材料。
发明内容
本发明的目的在于提供一种将多孔钛合金的优良的力学性能和镁金属生物活性有机结合的功能仿生性多孔钛合金股骨头支撑棒及其制备方法,既实现有效力学支撑防止股骨头塌陷,又利用镁金属生物活性改善局部骨再生和血管形成环境,从而为股骨头坏死的治疗提供有效的解决方案。
为达到上述目的,本发明的制备方法包括以下步骤:
1)利用3D打印技术制备多孔钛合金股骨头支撑棒;
2)利用多弧离子镀膜在步骤1)所述的多孔钛合金内外表面制备高纯度镁涂层,得到功能仿生性多孔钛合金股骨头支撑棒。
所述步骤1)的多孔钛合金股骨头支撑棒选用医用级Ti6Al4V粉末通过电子束熔融或激光选区熔融进行3D打印制备。
所述步骤1)的多孔钛合金股骨头支撑棒主体部分长50~60mm,直径6~8mm的圆柱体,分为尾、体、头三部分,其中尾部为长10mm,直径6~8mm的实心圆柱体;体部为长30~40mm,直径6~8mm的多孔圆柱体,头部为直径6~8mm的多孔半球形结构,体部和头部的孔隙率为70%~80%,平均孔径为500μm。
所述的多孔钛合金股骨头支撑棒的头部弹性模量为1.5Gpa,体部弹性模量为0.7Gpa-3.0Gpa,尾部弹性模量15.0GPa。
所述步骤2)的高纯度镁的纯度为99.99%。
所述步骤2)的多弧离子镀膜技术参数为:采用高纯镁金属作为轰击靶材,将多孔钛合金股骨头支撑棒放置在距离阴极靶材40cm的位置,设定恒定靶电弧电流为50A,在氩气压力为3.5×10-2MPa的条件下对多孔钛合金股骨头支撑棒表面溅射30min,溅射过程中,采用脉冲电源在多孔钛合金股骨头支撑棒表面叠加阴极偏压,使镁涂层能够均匀的沉积于多孔钛合金内外表面其中,脉冲偏压为100V,脉冲频率为30000Hz,占空比为40%,保持电流密度在0.12-0.16A,同时两电弧源电流恒定为0.1A,溅射过程中保持多孔钛合金股骨头支撑棒的温度为245℃。
按照以上制备方法制成的功能仿生性多孔钛合金股骨头支撑棒为主体部分长50~60mm,直径6~8mm的圆柱体,分为尾、体、头三部分,其中尾部为长10mm,直径6~8mm的实心圆柱体;体部为长30~40mm,直径6~8mm的多孔圆柱体,头部为直径6~8mm的多孔半球形结构,体部和头部的孔隙率为70%~80%,平均孔径为500μm,在多孔钛合金股骨头支撑棒内外表面均有高纯度镁涂层。
所述的多孔钛合金股骨头支撑棒的头部弹性模量为1.5Gpa,体部弹性模量为0.7Gpa-3.0Gpa,尾部弹性模量15.0GPa。
本发明采用电子束熔融(EBM)技术,以钛合金为原材料制备与人体骨力学强度和弹性模量相匹配的股骨头支撑棒,继而采用多弧离子镀膜技术在多孔钛合金内外表面制备高纯度功能性镁涂层。将多孔钛合金的优良的力学性能和镁金属生物活性有机结合,既实现有效力学支撑防止股骨头塌陷,又利用镁金属生物活性改善局部骨再生和血管形成环境,从而为股骨头坏死的治疗提供有效的解决方案。
所制备的材料由于其具有良好的力学强度,较好的血管形成效应及促成骨效应,故可用于股骨头支撑棒及其它部位骨修复材料。本材料制备方法简便易行,对人体环境友好,可批量生产,在医用骨修复材料领域应用前景良好。
附图说明
图1为本发明的侧面剖视图;
图2为本发明体部的俯视图;
图3为多孔结构支架表面镁涂层分布图。
具体实施方式
下面结合附图对本发明作进一步详细说明。
1)股骨头多孔钛合金支架材料设计
根据待置换的股骨头颈部的三维模型数据和生物力学参数,采用Mimics以及CAD软件设计长为50-60mm、直径为6-8mm的股骨头支架。支架设计要满足头颈支撑的力学强度要求,根据前期体外力学测试结果,实现弹性模量在头、体、尾部递变:参见图1,头部弹性模量约为1.5Gpa,长6-8mm;参见图2,体部弹性模量0.7Gpa-3.0Gpa,长度30-40mm;尾部弹性模量15.0GPa,长度10mm。支架材料的孔径大小及孔隙率在仿生设计的基础上,尽量满足适合骨长入的孔径尺寸,(孔隙率70%-80%,平均孔径500μm,弹性模量3.0GPa),此外,还设计结构弹性模量均一的支架材料,与本研究设计的力学仿生多孔钛合金支架进行对比研究。
通过反复的三维有限元分析和体外生物力学实验,对支架材料设计进行优化,通过改变孔径、孔隙率和头、体、尾部比例措施,使之在结构仿生的基础上进一步达到力学仿生。
2)多孔钛合金支撑棒的加工制备
将预先设计好的CAD模型数据导入EBM设备,在制备过程中,首先在650℃以30mA的电子束流,以15000mm/s的扫描速度预热粉末,然后以6mA的电子束流,400mm/s的扫描速度由计算机控制,按照设定好的程序逐层熔化Ti6AL4V粉末,最后制备成与设计形状一致的Ti2448合金多孔材料。本发明还将激光选区熔融技术作为备选的制备方案,如果EBM技术不能满足仿生支架材料的加工需求,则采用激光选区熔融技术加以制备。
3)多孔钛合金镁金属涂层制备
采用高纯镁金属(99.99%)作为轰击靶材,样品放置在距离阴极靶材40cm的位置,设定恒定靶电弧电流为50A,在氩气压力为3.5×10-2MPa的条件下对基体表面溅射30min。溅射过程中,通过脉冲电源在基体表面叠加阴极偏压,参数如下:脉冲偏压为100V,脉冲频率为30000Hz,占空比为40%,保持电流密度范围在0.12-0.16A,同时两电弧源电流恒定为0.1A。溅射过程中基体的温度大约为245℃。对于多孔基体,可以参考平面基体的沉积条件。与平面基体不同的是多孔基体孔隙内部相对孔隙更不易沉积涂层,拟采取调整偏压、弧流、占空比等参数,使镁涂层可均匀的沉积于多孔钛合金内外表面(参见图3),得到功能仿生性多孔钛合金股骨头支撑棒。将上述材料制备完成后,分别用丙酮、无水乙醇、蒸馏水超声清洗后,烘干,经60Co辐照灭菌后备用。
按以上制备方法制得的功能仿生性多孔钛合金股骨头支撑棒主体部分长50~60mm,直径6~8mm的圆柱体,分为尾、体、头三部分,其中尾部为长10mm,直径6~8mm的实心圆柱体,尾部弹性模量15.0GPa;体部为长30~40mm,直径6~8mm的多孔圆柱体,弹性模量为0.7Gpa-3.0Gpa;头部为直径6~8mm的多孔半球形结构,弹性模量为1.5Gpa,体部和头部的孔隙率为70%~80%,平均孔径为500μm,在多孔钛合金股骨头支撑棒内外表面均有高纯度镁涂层。
Claims (8)
1.一种功能仿生性多孔钛合金股骨头支撑棒的制备方法,其特征在于,包括如下步骤:
1)利用3D打印技术制备多孔钛合金股骨头支撑棒;
2)利用多弧离子镀膜在步骤1)所述的多孔钛合金骨头支撑棒内外表面制备高纯度镁涂层,得到功能仿生性多孔钛合金股骨头支撑棒。
2.根据权利要求1所述的功能仿生性多孔钛合金股骨头支撑棒的制备方法,其特征在于:所述步骤1)的多孔钛合金股骨头支撑棒选用医用级Ti6Al4V粉末通过电子束熔融或激光选区熔融进行3D打印制备。
3.根据权利要求1所述的功能仿生性多孔钛合金股骨头支撑棒的制备方法,其特征在于:所述步骤1)的多孔钛合金股骨头支撑棒主体部分长50~60mm,直径6~8mm的圆柱体,分为尾、体、头三部分,其中尾部为长10mm,直径6~8mm的实心圆柱体;体部为长30~40mm,直径6~8mm的多孔圆柱体,头部为直径6~8mm的多孔半球形结构,体部和头部的孔隙率为70%~80%,平均孔径为500μm。
4.根据权利要求3所述的功能仿生性多孔钛合金股骨头支撑棒的制备方法,其特征在于:所述的多孔钛合金股骨头支撑棒的头部弹性模量为1.5Gpa,体部弹性模量为0.7Gpa-3.0Gpa,尾部弹性模量15.0GPa。
5.根据权利要求1所述的功能仿生性多孔钛合金股骨头支撑棒的制备方法,其特征在于:所述步骤2)的高纯度镁的纯度为99.99%。
6.根据权利要求1所述的功能仿生性多孔钛合金股骨头支撑棒的制备方法,其特征在于:所述步骤2)的多弧离子镀膜技术参数为:采用高纯镁金属作为轰击靶材,将多孔钛合金股骨头支撑棒放置在距离阴极靶材40cm的位置,设定恒定靶电弧电流为50A,在氩气压力为3.5×10-2MPa的条件下对多孔钛合金股骨头支撑棒表面溅射30min,溅射过程中,采用脉冲电源在多孔钛合金股骨头支撑棒表面叠加阴极偏压,使镁涂层能够均匀的沉积于多孔钛合金内外表面其中,脉冲偏压为100V,脉冲频率为30000Hz,占空比为40%,保持电流密度在0.12-0.16A,同时两电弧源电流恒定为0.1A,溅射过程中保持多孔钛合金股骨头支撑棒的温度为245℃。
7.一种功能仿生性多孔钛合金股骨头支撑棒,其特征在于:所述的多孔钛合金股骨头支撑棒为主体部分长50~60mm,直径6~8mm的圆柱体,分为尾、体、头三部分,其中尾部为长10mm,直径6~8mm的实心圆柱体;体部为长30~40mm,直径6~8mm的多孔圆柱体,头部为直径6~8mm的多孔半球形结构,体部和头部的孔隙率为70%~80%,平均孔径为500μm,在多孔钛合金股骨头支撑棒内外表面均有高纯度镁涂层。
8.根据权利要求7所述的功能仿生性多孔钛合金股骨头支撑棒,其特征在于:所述的多孔钛合金股骨头支撑棒的头部弹性模量为1.5Gpa,体部弹性模量为0.7Gpa-3.0Gpa,尾部弹性模量15.0GPa。
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