CN111020324A - 由含有掺杂纳米金刚石的镁或镁合金组成的可吸收植入材料 - Google Patents

由含有掺杂纳米金刚石的镁或镁合金组成的可吸收植入材料 Download PDF

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CN111020324A
CN111020324A CN201910951410.7A CN201910951410A CN111020324A CN 111020324 A CN111020324 A CN 111020324A CN 201910951410 A CN201910951410 A CN 201910951410A CN 111020324 A CN111020324 A CN 111020324A
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哈乔·迪仁格
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Helmholtz Zentrum Geesthacht Zentrum fuer Material und Kustenforschung GmbH
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Abstract

本发明涉及由镁或镁合金构成的可吸收植入材料及其制备方法。已知的可吸收植入物的缺点在于，在医学植入过程及紧接之后期间植入物的位置只能通过X射线检查来跟踪。根据本发明，提供了一种可吸收植入材料，其包括在由镁或镁合金组成的基质中的均匀分布的Fe掺杂纳米金刚石。Fe掺杂的纳米金刚石对生物无害。这允许通过磁共振成像检测患者血浆中的植入材料。根据本发明的可吸收植入物材料通过以下方法生产，其中将镁或镁合金熔化，将Fe掺杂的纳米金刚石添加到熔体中，并且将具有Fe掺杂纳米金刚石的由镁或镁合金组成的熔体进行超声波处理。

Description

由含有掺杂纳米金刚石的镁或镁合金组成的可吸收植入材料
技术领域
本发明涉及由镁或镁合金组成的植入材料及其制造方法。
背景技术
目前，医用级钢或钛组成的金属植入物被用于兽医学和人类医学中以治疗负重长骨的骨折。然而，就其机械性能而言，这种植入物比骨更坚硬，从而可能导致应力遮蔽现象。由于这些和其他原因，相关的植入物通常在其功能完成后被移除，从而由于所需的麻醉和重新的组织创伤，这就会对患者造成负担。
可吸收植入物用于骨折治疗日益受到关注。目标是，随着愈合骨强度的增加，植入物通过其稳定性的缓慢降低而进行应力调节。迄今为止所采用的可吸收植入物是由不同的聚合物组成，由于其在受应力骨上的强度低，就不能最佳发挥作用。与其他金属植入材料相比，镁及其合金表现出类似于骨骼的弹性模量和较好的拉伸强度和抗压强度。镁及其合金比可吸收聚合物具有更高的强度和更大的弹性模量，因此在科学研究中受到关注。用于治疗骨折的生物可吸收植入物，尤其是由镁或镁合金组成的植入物，可见于，例如，EP 2 318057 B1及其中引用的出版物或DE 10 2005 060 203 A1。
可吸收植入物不仅用于骨折治疗。如今，由镁及其合金组成的植入物还经常用作支架，其用于治疗狭窄(血管收缩)。所述支架具有管状或空心圆柱形基体，其两个纵向端部是敞开的。这种内置假体的管状基体被插入待治疗的血管中用以支撑血管。由镁或镁合金组成的可生物降解的支架可见于例如EP 2 198 898 B1和其中引用的出版物。
然而，已知的可吸收植入物的缺点在于，在医学植入过程及紧接之后期间植入物的位置只能通过X射线检查来确定。植入物吸收也只能通过X射线检查进行跟踪。这样的检查相对复杂且成本高。
本发明的一个目的是提供一种由镁或镁合金组成的植入材料及其制造方法，所述植入物在医疗过程中的位置以及在患者体内的吸收可以通过简单的方式进行跟踪。
发明概述
所述目的能够通过根据权利要求1所述的植入材料实现，其中所述植入材料包括在由镁或镁合金组成的基质中均匀分布的Fe掺杂的纳米金刚石。
所述目的还能够通过权利要求6所述的植入材料制造方法实现，其中所述方法包括将镁或镁合金熔化，将Fe掺杂的纳米金刚石添加到熔体中，并且将具有Fe掺杂纳米金刚石的由镁或镁合金组成的熔体进行超声波处理。
具体实施方式
Fe掺杂的纳米金刚石(Fe-ND),例如，已被公开为蛋白质标记,见B.-R.Lin et al.“Fe Doped Magnetic Nanodiamonds Made by Ion Implantation as Contrast Agentfor MRI”Scientific Reports(2018)8:7058。迄今为止，Fe掺杂的纳米金刚石已被用于研究生物细胞过程的可视化。Fe掺杂的纳米金刚石对生物无害，并且可以作为对比剂使生物过程可见。
对于Fe掺杂的纳米金刚石的生产，我们称“通过离子注入制备的Fe掺杂的磁性纳米金刚石作为MRI的对比剂”。纳米金刚石是众所周知的，并且例如可以从Sigma-Aldrich购买。Fe离子可以容易地植入所述纳米金刚石中。为此，纳米金刚石优选悬浮在去矿物质水中，随后将悬浮液施加到硅晶片上。然后Fe离子可以通过溅射而注入纳米金刚石中。在该方法中，优选使用约100-200keV，例如约150keV的能量，以及约1x1015atoms/cm2至1x1016atoms/cm2，例如约5x1015atoms/cm2的剂量。
根据本发明，由镁或镁合金组成并且包含均匀分布的Fe掺杂的纳米金刚石的植入材料可以通过将Fe掺杂的纳米金刚石引入植入材料的熔体中来生产。然后，可以通过诸如MIM技术的粉末冶金方法挤出或加工所述植入材料以形成植入体。然后可借助于磁共振成像(MRI)或通过其他手段检测其在患者体内的位置。
随着植入物材料被患者体内吸收，Fe掺杂的纳米金刚石进入血液。所述Fe掺杂的纳米金刚石逐渐从体内排出。同样可以借助于磁共振成像(MRI)或其他方式来跟踪植入材料的退化。
如果用镁合金作为基质材料，则优选使用被认为对健康无害的合金元素。优选使用具有选自锂，钙，钾，锶，钡，钪，钇，镧，镨，钕，钐，铕，钆，镝，硅，铜，锌，镓，金，银，铋，铁及其组合的合金元素的镁合金。更优选使用如DE 10 2016 007 176 A1或DE 10 2016 119227 A1中所述的镁合金，而所述文献在此全部被参考引入。
根据本发明，所述植入材料是通过熔化镁或镁合金，将纳米金刚石添加到熔体，并使由镁或具有纳米金刚石的镁合金组成的熔体进行超声处理来生产。
这种将纳米颗粒均匀分布在由镁或镁合金组成的熔体中的方法被描述于H.Dieringa et al.“Ultrasound Assisted Casting of an AM60 Based Metal MatrixNanocomposite,Its Properties,and Recyclability”in Metals 2017,7,338，其在此被全部引入参考。
在优选的制备本发明的植入材料的方法中，在第一步骤中镁或镁合金优选在保护气体下熔化并且在置于烘箱中的常设模具中搅拌，在第二步骤中所述熔体与Fe掺杂的纳米金刚石混合，并且在第三步骤中引入熔体中的纳米金刚石通过超声波发生器被分散和解聚集。类似的方法被描述于H.Dieringa et al.“Ultrasound Assisted Casting of an AM60Based Metal Matrix Nanocomposite,Its Properties,and Recyclability”in Metals2017,7,338,其在此完全引入参考。所述熔体优选地被机械搅拌，优选于150至250rpm。
此后，将Fe掺杂的纳米金刚石加入到熔体中。在添加Fe掺杂的纳米金刚石之后，熔体用超声处理。为此，优选将超声波发生器引入熔体中。超声处理的时间优选为1分钟至10分钟，更优选为2分钟至5分钟。
进一步优选地，在除去搅拌器和超声波发生器之后，含有熔体的常设模具被浸入水浴中。因此，所述熔体从“底到顶”固化，从而避免形成缩孔。
根据本发明的植入材料优选地包括均匀分布的Fe掺杂的纳米金刚石，其在由镁或镁合金组成的基质中，含量为0.01％至3％重量，优选0.5％至1.5％重量，基于镁或镁合金的重量。所述纳米金刚石的粒径优选为1至20nm，更优选为3至8nm。
由此产生的植入材料可以随后以常规方式进一步加工。例如，所述植入材料可以重新熔化，然后浇铸到所需的模具中以形成植入体。所述材料也可以挤出，以便从挤出物制备植入物。或者，所述植入材料可以进一步加工形成粉末，并通过金属注射成型(MIM)进一步加工以形成植入体。
根据本发明的植入材料还可以借助MIM技术处理以形成金属植入体。借助MIM技术，可以在近净形工艺中制造小而复杂且精确成形的金属部件。MIM技术是所谓的粉末冶金方法的一部分，其中用于待生产的组件的起始材料不是固体金属体，而是细金属粉末。然后，MIM用于金属注射成型。在MIM方法中，金属粉末通过添加热塑性粘结剂而可流动，并且可流动的混合物被引入注塑模具中。模塑后，粘结剂部分被除去并且所述组分被烧结。镁组分可借助于MIM技术进行制备，其方法可见于M.Wolff et.al.“Magnesium powderinjection moulding for biomedical application”,Powder Metallurgy,2014(Vol.57,No.5),331-340，而该文在此完全引入参考。
当使用MIM技术时，所述粘结剂在浇铸或模塑期间提供临时粘结作用，并确保组件的稳定性，直到通过烧结金属粉末被最终压实。一些粘结剂通常在烧结之前已经被除去，例如借助于溶剂(溶剂脱脂)。其余的粘结剂在约300℃至500℃的温度下在热脱脂下分解并以气态形式逸出。

Claims (14)

1.一种植入材料，包括在由镁或镁合金组成的基质中的均匀分布的Fe掺杂的纳米金刚石。
2.根据权利要求1所述的植入材料，其中所述均匀分布的Fe掺杂的纳米金刚石，基于镁或镁合金的重量，在所述基质中的量为0.01％至3％重量。
3.根据权利要求2所述的植入材料，其中所述均匀分布的Fe掺杂的纳米金刚石，基于镁或镁合金的重量，在所述基质中的量为0.5％至1.5％重量。
4.根据前述权利要求任一项所述的植入材料，其中所述Fe掺杂的纳米金刚石的粒径为1至20nm。
5.根据权利要求4所述的植入材料，其中所述Fe掺杂的纳米金刚石的粒径为3至8nm。
6.制备前述权利要求任一项所述植入材料的方法，其中镁或镁合金被熔化，Fe掺杂的纳米金刚石被添加到熔体中，并且带有纳米金刚石的由镁或镁合金组成的熔体被进行超声处理。
7.根据权利要求6所述的方法，其中在第一步骤中所述镁或镁合金在保护气体下并且在设于烘箱中常设模具中搅拌下熔化，熔体由机械搅拌，随后加入Fe掺杂的纳米金刚石，并且所述熔体，在加入Fe掺杂的纳米金刚石之后，被进行超声处理。
8.根据权利要求7所述的方法，其中所述超声处理是通过引入所述熔体中的超声波发生器实现的。
9.根据权利要求6所述的方法，其中超声处理的时间为1分钟至10分钟。
10.根据权利要求9所述的方法，其中所述超声处理的时间为2分钟至5分钟。
11.根据权利要求7所述的方法，其中在所述超声处理之后常设模具被转移到水浴中，其中熔体固化。
12.根据权利要求6至11任一项所述的方法，其中，所述植入材料被重新熔化，然后浇铸到所需的模具中，以形成金属植入物。
13.根据权利要求6至11任一项所述的方法，其中所述植入材料被挤出并且挤出物用作制备植入物的基础材料。
14.根据权利要求6至11任一项所述的方法，其中所述植入材料通过MIM技术转换成金属植入物。
CN201910951410.7A 2018-10-10 2019-10-08 由含有掺杂纳米金刚石的镁或镁合金组成的可吸收植入材料 Pending CN111020324A (zh)

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