CN113005299B - 一种钽金属生物植入体及其制备方法 - Google Patents
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Abstract
本发明涉及一种钽金属生物植入体及其制备方法。该钽金属牙种植体的制备方法包括以下步骤：获得钽金属原料，所述钽金属原料的化学成分有如下特征：钽纯度≥99.999wt％，每种杂元素含量＜0.005ppm，所述杂元素选自以下元素的一种或多种：Al、Cr、U、Th、As、Hg、Pb；将钽金属原料加工成钽金属牙种植体。
Description
技术领域
本发明涉及医用材料领域，具体涉及一种钽金属生物植入体及其制备方法。
背景技术
目前生物植入体存在生物相容性不优越、耐腐蚀性差、部分植入件长期植入能够分解对人体有害元素等，而钽具有较强的生物相容性，其植入人体后有利于新生骨组织的长入，能够增强与骨组织的连结能力，促进骨组织的再生和重建，增加植入器件的长期生物稳定性，因此特别适用于骨替代、关节置换和人体组织填充等领域，并且可以永久性植入人体。
发明内容
发明人发现，钽金属作为生物植入体(简称植入体)具有诸多优势，首先，好的生物相容性，就是材料植入人体后与人体相容程度，也就是说是否会对人体组织造成毒害作用；研究表明，钽是目前生物相容性最好的金属材料。其次，高的生物安全性，即消除生物材料对人体器官的破坏性(比如细胞毒性和致癌性)。不溶性的钽盐经过口腔或局部注射均不被人体吸收，胃肠道对可溶性钽盐的吸收量也极小。钽一旦进入人体后，负责清除钽的主要载体是吞噬细胞，体内吞噬细胞在接触钽尘1小时后均可存活且无细胞变性，仅伴有葡萄糖氧化的明显增加。而在相同条件下，矽尘则可使吞噬细胞出现严重胞浆变性和死亡，这些都证明了钽没有细胞毒性，具有很高的生物安全性。最后，钽及其合金是与人体亲和力较好的金属，具有诱导骨骼生长、抑制感染的独特能力。
本公开提供一种低植入风险的钽金属生物植入体及其制备方法。
本公开提供一种钽金属生物植入体的制备方法，该方法能够将生物植入体的杂元素如：Al、Cr、U、Th、As、Hg、Pb元素控制到每种＜0.005ppm，材料整体纯度Ta≥99.999％，可以避免因材料自身原因造成的植入风险。
在一些实施方案中，本公开方法还将原料中对打印质量有较大影响的气体元素控制到：H≤2ppm，O≤50ppm，C≤15ppm，N≤5ppm，进一步改善了植入体的加工质量。
在一些方面，本公开提供一种钽金属生物植入体的制备方法，包括以下步骤：
-获得钽金属原料，所述钽金属原料的化学成分有如下特征：
钽纯度≥99.999wt％，每种杂元素含量＜0.005ppm，所述杂元素选自以下元素的一种或多种：Al、Cr、U、Th、As、Hg、Pb；
-将钽金属原料加工成钽金属生物植入体。
在一些实施方案中，所述钽金属原料是电子束炉熔炼锭。
电子束炉熔炼锭是采用电子束熔炼技术获得的钽金属锭。电子束熔炼指技术的是在真空下将高速电子束流的动能转换为热能作为热源来进行金属熔炼的一种真空熔炼方法。
在一些实施方案中，所述加工包括以下一项或多项操作：锻造、轧制、热处理。
在一些实施方案中，所述加工具有以下一项或多项加工参数：
-锻造加工率≤98％，例如30％-60％；
-轧制加工率≤98％，例如45％-70％；
-热处理温度900-1300℃，例如900-1300℃；
-热处理保温时间为≤120min，例如30-120min。
上述特定的加工程序有利于改善种植体的性能。
在一些实施方案中，所述钽金属原料是钽金属粉末。
在一些实施方案中，钽金属原料的化学成分还有如下特征：H≤2ppm，O≤50ppm，C≤15ppm，N≤5ppm。
在一些实施方案中，所述钽金属粉末具有以下一项或多项特征：
-球形度≥99％；
-粉末粒径范围15-53μm；
-粉末氧含量≤50ppm；
-松装密度≥8g/cm3，例如8～9g/cm3；
-流动性≤2s/50g，例如1.5s/50g～2s/50g。
在一些实施方案中，所述加工为增材制造加工(也称3D打印)。
在一些方面，本公开提供一种植入体，由上述任一项所述的方法制备获得。
在一些实施方案中，植入体具有以下特征：钽纯度≥99.999wt％，每种杂元素含量＜0.005ppm，所述杂元素选自以下元素的一种或多种：Al、Cr、U、Th、As、Hg、Pb。
在一些实施方案中，植入体为牙种植体。
术语说明：
术语“增材制造”，也称为3D打印，被理解为意指用于通过添加材料来制造的方法。增材制造有利地是计算机辅助的。增材制造可以具体地通过添加材料使零件成形来执行，例如通过堆叠连续的层来执行。因此，增材制造与材料的去除或对其实施方案施加几何约束的模制工艺相反，或者与由化学反应产生的工艺相反，如通常被实施为产生海绵材料并且其结果是随机的和/或不规则的结构的工艺。
术语“增材制造”，也称为3D打印，是指用于构建三维物体的工艺，其中形成材料层以构建物体。这样的工艺的例子包括但不限于选择性激光熔化(SLM)、选择性激光烧结(SLS)、直接金属激光烧结(DMLS)、熔融沉积成型(FDM)。
术语“生物植入体”是指用于替换或修复肌肉或骨骼系统的部件。例如，植入物包括用于替换或修复任何骨骼的植入物，所述骨骼示例性地包括牙、膝，髋，踝，肩，腕和手指或脚趾关节等。此外，植入物的形式可以是板，线，螺钉，销，杆，钉等。植入物的植入对象例如是人。
有益效果
1、采用本公开方法可以将对生物体有风险的杂元素如Al、Cr、U、Th、As、Hg、Pb元素控制在每种＜0.005ppm，材料整体纯度Ta≥99.999％，可以避免因材料自身原因造成的植入风险。
2、采用本公开方法获得的植入体表面光洁度Ra≤0.3μm，在植入过程中将降低对牙床的损伤。
3、采用本公开方法获得的植入体致密度≥99.5％，可以保证植入体内部质量的可靠性。
具体实施方式
下面将结合实施例对本发明的实施方案进行详细描述，但是本领域技术人员将会理解，下列实施例仅用于说明本发明，而不应视为限定本发明的范围。实施例中未注明具体条件者，按照常规条件或制造商建议的条件进行。所用药品或仪器未注明生产厂商者，均为可以通过市购获得的常规产品。
实施例1
1、通过电子束炉熔炼获得高纯锭材，化学成分为Ta≥99.999％，Al、Cr、U、Th、As、Hg、Pb分别＜0.005ppm。
2、对高纯锭材进行机械加工，获得钽棒。
机械加工参包括锻造、轧制、热处理，它们的参数如下：
表1
钽棒直径：3.8-5.5mm。
钽棒化学成分为Ta≥99.999％，Al、Cr、U、Th、As、Hg、Pb均＜0.005ppm，Al、Cr、U、Th、As、Hg、Pb均＜0.005ppm。
4、对钽棒进行机械加工，获得以下规格的钽金属牙种植体：最大直径3.5mm，长度14mm。
5、钽金属牙种植体应按照《中华人民共和国药典(二部)》“无菌检查法”试验无菌包装出厂。
实施例2
1、提供球形钽粉，其参数如下：
球形度≥99％，粉末粒径范围15-53μm，粉末氧含量≤50ppm，松装密度≥8.8g/cm3，流动性≤1.8s/50g(采用霍尔流速计检测)。
化学成分为Ta≥99.999％，Al、Cr、U、Th、As、Hg、Pb每种＜0.005ppm。以及H≤2ppm，O≤50ppm，C≤15ppm，N≤5ppm。
球形钽粉是通过等离子雾化法方式制备的。上述球形钽粉的特点在于纯度较高、杂质元素含量较低，对人体影响更低，植入风险更低。而且上述球形钽粉进一步限值了H、O、C、N元素的含量，这有利于改善粉末的加工质量。
2、采用铺粉式激光3D打印成型工艺将上述球形钽粉加工为以下规格的钽金属牙种植体：最大直径3.5mm，长度14mm。
3、钽金属牙种植体按照《中华人民共和国药典(二部)》“无菌检查法”试验无菌包装出厂。
分析检测
对实施例1和2制备的牙种植体进行分析检测，结果如下：
1)牙种植体的长度、直径公差≤0.2mm，牙种植体与种植体基台的内连接界面锥度偏差≤±3％，牙种植体与牙种植体基台的间隙≤0.03mm.
2)牙种植体与牙种植体基体基台的最大扭矩外联接N≥60Ncm，内连接最大扭矩外联接N≥70Ncm。
扭矩测试方法如下：牙种植体固定在扭矩测定仪上，扭矩测定仪的测量精度≥0.01Nm，另外，用扳手紧固中央螺钉或种植体基，直至扭矩测定仪达到生产厂技术文件中规定值的120％，保持载荷5s，肉眼观察牙种植体及配套部件，不得出现变形和断裂现象。反方向松开中央螺钉或种植体基台，读取扭矩测定仪上松开过程的最大扭矩最大紧固扭矩75％以上。
3)疲劳极限符合YY/T 0521-2009试验标准下要求。
4)生物学性能满足YY/T 0268-2008的各项性能要求，致密性符合GB/T 3850-2015要求。
5)钽金属牙种植体表面无裂纹、划痕、锋棱等宏观缺陷，无外来附着物，表面粗糙度采用粗糙度仪进行同炉打印样件检测Ra≤0.3μm。
6)按照《中华人民共和国药典(二部)》“细菌内毒素检测法”，钽金属牙种植体的细菌内小于0.25EU/mL。
7)钽金属牙种植体的致密度≥99.5％
根据上述检测结果，说明本发明方法有如下优点：
1、采用本方案可以将杂元素如Al、Cr、U、Th、As、Hg、Pb元素控制到每种＜0.005ppm，材料整体纯度Ta≥99.999％；
以上对成分的控制较传统方案有很大的提高，本公开的种植体可以避免因材料自身原因造成的植入风险。
2、采用本公开方法获得的牙种植体表面光洁度Ra≤0.3μm，在植入过程中将降低对牙床的损伤。
3、采用本公开方法获得的植入体的致密度≥99.5％，可以保证植入体内部质量的可靠性。
尽管本发明的具体实施方式已经得到详细的描述，但本领域技术人员将理解：根据已经公开的所有教导，可以对细节进行各种修改变动，并且这些改变均在本发明的保护范围之内。本发明的全部范围由所附权利要求及其任何等同物给出。
Claims (8)
1.一种钽金属生物植入体的制备方法，包括以下步骤：
-获得钽金属原料，所述钽金属原料是电子束炉熔炼锭，所述钽金属原料的化学成分有如下特征：
钽纯度≥99.999wt％，每种杂元素含量＜0.005ppm但不为零，所述杂元素选自以下元素的一种或多种：Al、Cr、U、Th、As、Hg、Pb；
-将钽金属原料加工成钽金属生物植入体；
所述钽金属原料中全部元素的含量之和为100wt％。
2.根据权利要求1所述的方法，所述加工包括以下一项或多项操作：锻造、轧制、热处理。
3.根据权利要求2所述的方法，所述加工具有以下一项或多项加工参数：
-锻造加工率≤98％；
-轧制加工率≤98％；
-热处理温度900～1300℃；
-热处理保温时间为≤120min。
4.根据权利要求1所述的方法，所述钽金属原料的化学成分还有如下特征：H≤2ppm，O≤50ppm，C≤15ppm，N≤5ppm。
5.一种植入体，由权利要求1～4任一项所述的方法制备获得。
6.根据权利要求5所述的植入体，其具有以下特征：
钽纯度≥99.999wt％，每种杂元素含量＜0.005ppm，所述杂元素选自以下元素的一种或多种：Al、Cr、U、Th、As、Hg、Pb。
7.根据权利要求6所述的植入体，所述植入体还有如下特征：H≤2ppm，O≤50ppm，C≤15ppm，N≤5ppm。
8.根据权利要求7所述的植入体，其为牙种植体。
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