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CN114099081A - 医用镁合金骨植入颗粒及制备方法 - Google Patents

医用镁合金骨植入颗粒及制备方法 Download PDF

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CN114099081A
CN114099081A CN202111416571.XA CN202111416571A CN114099081A CN 114099081 A CN114099081 A CN 114099081A CN 202111416571 A CN202111416571 A CN 202111416571A CN 114099081 A CN114099081 A CN 114099081A
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sealing
magnesium alloy
ball
medical magnesium
alloy bone
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杨光
王琮玮
王金业
杨立宁
王琮瑜
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Hebei University of Science and Technology
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Hebei University of Science and Technology
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Abstract

本发明提供了一种医用镁合金骨植入颗粒及制备方法，医用镁合金骨植入颗粒包括基球、密封球、支撑杆以及球形多孔层。密封球设有多个，且各密封球的直径均大于基球；各密封球的直径依次递增，且各密封球均与基球同心设置；支撑杆设有多个，各支撑杆均布在基球及密封球上；每个支撑杆均具有两个端部，其中一个端部位于基球的球心处，另一个端部沿着基球的半径方向依次穿过各密封球并伸出至直径最大的密封球外部；球形多孔层套设在直径最大的密封球的外部，且与各支撑杆的另一端固定连接。本发明提供的医用镁合金骨植入颗粒及制备方法，旨在能够解决现有的医用镁合金植入体因降解速率较快且无法调控降解时间而导致的适应性及实用性差的问题。

Description

医用镁合金骨植入颗粒及制备方法
技术领域
本发明属于骨支架材料构建技术领域，具体涉及医用镁合金骨植入颗粒及制备方法。
背景技术
因先天性畸形、骨疾病、骨创伤等原因导致产生较大面积的骨缺损，对人体产生严重危害。由于病患部位无法通过自身愈合恢复，往往需要通过手术配合医用植入体对其进行修复或替换。传统治疗方法通过自体骨移植进行修复，但自体骨取材有限，且需额外进行手术取骨，易造成术后取骨区出血、感染，加重患者痛苦；同种异体骨虽来源广泛，却存在疾病传播、诱发免疫反应及骨愈合不良等缺陷。因此，医用镁合金植入体因具有可降解的功能，受到广泛应用。
现有技术中，在体液环境中，医用镁合金腐蚀速率较快，常常导致植入物过早失效。因此通常会对镁合金植入物的表面覆设高分子涂层和无机涂层，以调控合金降解速率、提高生物相容性。该种改进结构虽然能够延长一定的降解速率，但是相对于人体自身的修复速率，该种镁合金植入物的降解时间依然相对较快，进而导致无法适应一部分人体。因此，现有的医用镁合金植入物降解速率较快，并且无法调控降解时间，其适应性较差，实用性差。
发明内容
本发明实施例提供医用镁合金骨植入颗粒及制备方法，旨在能够解决现有的医用镁合金植入体因降解速率较快且无法调控降解时间而导致的适应性及实用性差的问题。
为实现上述目的，本发明采用的技术方案是：提供医用镁合金骨植入颗粒及制备方法，医用镁合金骨植入颗粒包括：
基球；
密封球，设有多个，各所述密封球均具有球形空腔，且各所述密封球的直径均大于所述基球；各所述密封球的直径依次递增，且各所述密封球均与所述基球同心设置，任意两个相邻的密封球之间形成密封腔室；
支撑杆，设有多个，各所述支撑杆均布在所述基球及所述密封球上；每个所述支撑杆均具有两个端部，其中一个端部位于所述基球的球心处，另一个端部沿着所述基球的半径方向依次穿过各所述密封球并伸出至直径最大的所述密封球外部；以及
球形多孔层，套设在直径最大的所述密封球的外部，且与各所述支撑杆的另一端固定连接；所述球形多孔层上具有若干用于消除应力屏蔽效应的孔。
在一种可能的实现方式中，由直径最小的所述密封球至直径最大的所述密封球，各所述密封球的壁厚依次增大。
在一种可能的实现方式中，各所述支撑杆均为阶梯轴型外形结构；其中，各所述支撑杆位于所述基球一端的直径小于所述支撑杆伸出端的直径。
在一种可能的实现方式中，各所述支撑杆与所述基球及各所述密封球一体成型连接。
在一种可能的实现方式中，所述基球为空心结构。
在一种可能的实现方式中，所述球形多孔层上的孔为三角形孔。
本发明的再一目的是提供一种医用镁合金骨植入颗粒的制备方法，包括：
原料配制，通过混合纯Mg粉末、Mg-5Zn中间合金粉末及Mg-15Gd中间合金粉末以配置Mg-1Zn-0.5Gd合金粉末；
试件测试，制作测试试件，并将所述测试试件放入至模拟液内，以测试腐蚀速率是否符合要求；
设计建模，对由所述权利要求1-6任一项所述的医用镁合金骨植入颗粒进行设计，以确定所述基球、各所述密封球、各所述支撑杆以及所述球形多孔层的参数，并绘制所述医用镁合金骨植入颗粒的模型；以及
打印制作，所述原料配制步骤中配制的Mg-1Zn-0.5Gd合金粉末置于封闭箱内，向其中通入惰性气体，使用第一功率激光以第一扫描速度使所述Mg-1Zn-0.5Gd合金粉末成型，以打印制备所述设计建模中所绘制的所述医用镁合金骨植入颗粒。
在一种可能的实现方式中，所述惰性气体为氩气；
所述打印制作采用3D打印机，其中所述第一功率为95W，所述第一扫描速度为350mm/s。
本发明提供的医用镁合金骨植入颗粒的有益效果在于：与现有技术相比，通过设置多个具有球形空腔的密封球，各密封球与基球同心设置，且各密封球的直径依次递增，任意两相邻的密封球之间形成密封腔室，通过对密封层数量的调控，从而调控医用镁合金骨植入颗粒的腐蚀速率及残余力学性能。设置多个支撑杆，各支撑杆均布在基球和密封球上，支撑杆的杆径决定了医用镁合金骨植入颗粒的腐蚀失效时间。球形多孔层上设有若干孔，孔结构能让细胞向医用镁合金骨植入颗粒的内部攀附生长，以使镁合金骨植入颗粒与人体结构融化，还能减小弹性模量，消除应力屏蔽效应，实用性强。
附图说明
图1为本发明实施例提供的医用镁合金骨植入颗粒的结构示意图；
图2为本发明实施例提供的球形多孔层的结构示意图；
图3为本发明实施例提供的支撑杆的结构示意图；
图4为本发明实施例提供的密封球的结构示意图；
图5为本发明实施例提供的封堵结构的示意图。
附图标记说明：10、医用镁合金骨植入颗粒；11、球形多孔层；12、支撑杆；13、密封球；14、封堵结构。
具体实施方式
为了使本发明所要解决的技术问题、技术方案及有益效果更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
需要说明的是，术语“长度”、“宽度”、“高度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“头”、“尾”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
还需要说明的是，除非另有明确的规定和限定，“安装”、“连接”、“固定”、“设置”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接；可以是直接连接，也可以通过中间媒介间接连接，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。
此外，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个该特征。此外，“多个”、“若干”的含义是两个或两个以上，除非另有明确具体的限定。
请一并参阅图1至图5，现对本发明提供的医用镁合金骨植入颗粒及制备方法进行说明。所述医用镁合金骨植入颗粒10，包括基球、密封球13、支撑杆12以及球形多孔层11。
密封球13设有多个。各密封球13均具有球形空腔，且各密封球13的直径均大于基球的直径。各密封球13的直径依次递增，且各密封球13均与基球同心设置，任意两个相邻的密封球13之间形成密封腔室。
支撑杆12设有多个，各支撑杆12均布在基球和密封球13上。每个支撑杆12均具有两个端部，其中一个端部位于基球的球心处，另一个端部沿着基球的半径方向依次穿过各密封球13并伸出至直径最大的密封球13外部。
球形多孔层11套设在直径最大的密封球13的外部，且与各支撑杆12的另一端固定连接。球形多孔层11上设有若干用于消除应力屏蔽效应的孔。
本发明实施例提供的医用镁合金骨植入颗粒，与现有技术相比，通过设置多个具有球形空腔的密封球，各密封球与基球同心设置，且各密封球的直径依次递增，任意两相邻的密封球之间形成密封腔室，通过对密封层数量的调控，从而调控医用镁合金骨植入颗粒的腐蚀速率及残余力学性能。设置多个支撑杆，各支撑杆均布在基球和密封球上，支撑杆的杆径决定了医用镁合金骨植入颗粒的腐蚀失效时间。球形多孔层上设有若干孔，孔结构能让细胞向医用镁合金骨植入颗粒的内部攀附生长，以使镁合金骨植入颗粒与人体结构融化，还能减小弹性模量，消除应力屏蔽效应，实用性强。
需要说明的是，应力屏蔽效应为当两种弹性模量不同的材料放在一起受力时，弹性模量大的材料承载更大的应力。由于镁合金的弹性模量远大于人体骨骼，在医用镁合金骨植入颗粒10植入人体后承担更多的应力作用，人骨得不到锻炼，不利于新骨的生长与恢复，所以在球形多孔层11上设置若干用于消除应力屏蔽效应的孔。
在一些实施例中，请参阅图1，随着密封球13直径的增大，密封球13的壁厚依次增大。本实施例中，通过对密封球13数量与层厚的调控，从而控制医用镁合金骨植入颗粒10的腐蚀速率与残余力学性能。
作为本发明实施例的一种具体实施方式，基球的直径为4.1mm，层厚为400μm。密封球13与基球同心设置，密封球13在医用镁合金骨植入颗粒10内部逐层叠套，直径由外向内分别为13.5mm、8.6mm，其层厚分别为800μm、600μm。
在一些实施例中，请参阅图4，密封球13表面对称开两锥孔，锥孔的孔径为400μm，锥度为30°。本实施例中，在密封球13表面设置锥孔，通过锥孔清除密封球13中的残余粉末。
在一些实施例中，请参阅图5，本发明实施例提供的医用镁合金骨植入颗粒10还包括封堵结构14，封堵结构14与密封球13表面的锥孔适配，用于填补密封球13表面的锥孔。本实施例中，利用封堵结构14将密封球13表面的锥孔封堵住，从而当密封球13未被腐蚀时，避免密封球13空腔内的支撑杆12受到腐蚀，控制医用镁合金骨植入颗粒10的腐蚀速率。
在一些实施例中，请参阅图1及图3，各支撑杆12均为阶梯轴型外形结构。各支撑杆12位于基球一端的直径小于支撑杆12伸出端的直径。本实施例中，各个支撑杆12均为阶梯轴型外形结构，且各支撑杆12位于基球一端的直径小于支撑杆12伸出端的直径，从而根据各支撑杆12不同部位的杆径调节，控制医用镁合金骨植入颗粒10的腐蚀速率及残余力学性能。
作为本发明实施例的一种具体实施方式，各支撑杆12均为阶梯轴型外形结构，由外向内分别为800μm、600μm、400μm、200μm。
在一些实施例中，请参阅图1，各支撑杆12与基球及各密封球13一体成型连接。本实施例中，在密封球13逐层遭受腐蚀破坏后，密封球13外部的杆径与密封球13内部的杆径相近，密封球13减缓了空腔内部支撑杆12的腐蚀，医用镁合金骨植入颗粒10的残余力学性能得到提高。
在一些实施例中，请参阅图1，基球为空心结构。
在一些实施例中，请参阅图1及图2，球形多孔层11上的孔为三角形孔，加强球形多孔层11的结构稳固性。
基于同一发明构思，本申请实施例还提供一种医用镁合金骨植入颗粒的制备方法，具体步骤如下：
S100、原料配制，通过混合纯Mg粉末、Mg-5Zn中间合金粉末及Mg-15Gd中间合金粉末以配置Mg-1Zn-0.5Gd合金粉末。
Mg-1Zn-0.5Gd合金粉末的粒径范围为15μm～53μm。
S200、试件测试，制作测试试件，并将所述测试试件放入至模拟液内，以测试腐蚀速率是否符合要求。
设计测试试件的尺寸为10mm×10mm×3mm。测试试件边缘有之间1mm的通孔，用于棉线悬挂。通过公式V＝(W-W1)/A*T计算其在模拟液中浸泡72小时后的平均腐蚀速率。
其中，V为Mg-1Zn-0.5Gd合金的平均腐蚀速率，单位为mg/cm2/day；W为试件浸泡前的重量，单位为mg；W1为试件浸泡后的重量，单位为mg；A为试件在浸泡前的表面积，单位为cm2；T为试件在模拟液内的浸泡时间，单位为d。
计算可知，Mg-1Zn-0.5Gd合金粉末在浸泡72小时内的的平均腐蚀速率为14.933mg/cm2/day。
在CAD软件中计算医用镁合金骨植入颗粒10的表面积与体积，并计算医用镁合金骨植入颗粒10各结构的理论腐蚀破坏时间。
S300、对上述医用镁合金骨植入颗粒10进行设计，以确定基球、各密封球13、各支撑杆12以及球形多孔层11的参数，并绘制医用镁合金骨植入颗粒10的模型。
根据计算所得参数在Solidworks软件中分别建立基球、密封球13、支撑杆12以及球形多孔层11的三维模型，并通过布尔求和功能将基球、密封球13、支撑杆12以及球形多孔层11的模型组合形成一个医用镁合金骨植入颗粒10。将设计出的医用镁合金骨植入颗粒10的模型导出为STL格式文件，并在Magics软件中对医用镁合金骨植入颗粒10的模型进行添加支撑、切片等处理操作。
S400、打印制作，原料配制步骤中配制的Mg-1Zn-0.5Gd合金粉末置于封闭箱内，向其中通入惰性气体，使用第一功率激光以第一扫描速度使Mg-1Zn-0.5Gd合金粉末成型，以打印制备设计建模中所绘制的医用镁合金骨植入颗粒10。
成型前将原料配制步骤中配制的Mg-1Zn-0.5Gd合金粉末置于封闭箱内，向其中通入惰性气体(作为保护气体)，将氧含量降于7000ppm以下，此时使用振动筛将粒径大于60μm的粉末与杂质筛除，将S300中得到的文件导入设备主机，使其生成激光加工路径。在成型过程中，向封闭箱内通入惰性气体，将氧含量降低至250ppm以下，使用第一功率激光以第一扫描速度对镁合金粉末打印成型。
在一些实施例中，惰性气体为氩气。打印制作采用3D打印机，其中第一功率为95W，第一扫描速度为350mm/s。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。

Claims (8)

1.医用镁合金骨植入颗粒，其特征在于，包括：
基球；
密封球，设有多个，各所述密封球均具有球形空腔，且各所述密封球的直径均大于所述基球；各所述密封球的直径依次递增，且各所述密封球均与所述基球同心设置，任意两个相邻的密封球之间形成密封腔室；
支撑杆，设有多个，各所述支撑杆均布在所述基球及所述密封球上；每个所述支撑杆均具有两个端部，其中一个端部位于所述基球的球心处，另一个端部沿着所述基球的半径方向依次穿过各所述密封球并伸出至直径最大的所述密封球外部；以及
球形多孔层，套设在直径最大的所述密封球的外部，且与各所述支撑杆的另一端固定连接；所述球形多孔层上具有若干用于消除应力屏蔽效应的孔。
2.如权利要求1所述的医用镁合金骨植入颗粒，其特征在于，由直径最小的所述密封球至直径最大的所述密封球，各所述密封球的壁厚依次增大。
3.如权利要求1所述的医用镁合金骨植入颗粒，其特征在于，各所述支撑杆均为阶梯轴型外形结构；其中，各所述支撑杆位于所述基球一端的直径小于所述支撑杆伸出端的直径。
4.如权利要求3所述的医用镁合金骨植入颗粒，其特征在于，各所述支撑杆与所述基球及各所述密封球一体成型连接。
5.如权利要求1所述的医用镁合金骨植入颗粒，其特征在于，所述基球为空心结构。
6.如权利要求1所述的医用镁合金骨植入颗粒，其特征在于，所述球形多孔层上的孔为三角形孔。
7.医用镁合金骨植入颗粒的制备方法，其特征在于，包括如下步骤：
原料配制，通过混合纯Mg粉末、Mg-5Zn中间合金粉末及Mg-15Gd中间合金粉末以配置Mg-1Zn-0.5Gd合金粉末；
试件测试，制作测试试件，并将所述测试试件放入至模拟液内，以测试腐蚀速率是否符合要求；
设计建模，对由所述权利要求1-6任一项所述的医用镁合金骨植入颗粒进行设计，以确定所述基球、各所述密封球、各所述支撑杆以及所述球形多孔层的参数，并绘制所述医用镁合金骨植入颗粒的模型；以及
打印制作，所述原料配制步骤中配制的Mg-1Zn-0.5Gd合金粉末置于封闭箱内，向其中通入惰性气体，使用第一功率激光以第一扫描速度使所述Mg-1Zn-0.5Gd合金粉末成型，以打印制备所述设计建模中所绘制的所述医用镁合金骨植入颗粒。
8.如权利要求7所述的医用镁合金骨植入颗粒的制备方法，其特征在于，所述惰性气体为氩气；
所述打印制作采用3D打印机，其中所述第一功率为95W，所述第一扫描速度为350mm/s。
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