CN105943148A - 一种个性化接骨板及其制造方法 - Google Patents

一种个性化接骨板及其制造方法 Download PDF

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CN105943148A
CN105943148A CN201610380903.6A CN201610380903A CN105943148A CN 105943148 A CN105943148 A CN 105943148A CN 201610380903 A CN201610380903 A CN 201610380903A CN 105943148 A CN105943148 A CN 105943148A
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傅山泓
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Guangzhou Xiongjun Intelligent Technology Co Ltd
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Abstract

本发明公开了一种个性化接骨板及其制造方法。镁合金通过3D打印形成的接骨板与患者骨接触的表面与患者骨的形状拟合接触。制造方法为：1）采用CTA扫描技术或MRI技术对患者骨部位进行立体造影，获得患者骨部位的三维数据；2）使用计算机辅助设计显示患者骨部位及确定接骨板形状尺寸以及对应连接方式；3）输出个性化接骨板数据，并使用金属粉末选区激光熔化3D打印机打印接骨板，所使用的镁合金的颗粒直径为15~45μm，且为球状。

Description

一种个性化接骨板及其制造方法
技术领域
本发明涉及接骨板和对应的制造方法。
背景技术
接骨板是指带孔板状骨折内固定器件。临床上常与骨螺钉或接骨丝配合使用。现有的接骨板都呈直板状，如在YY0017-2008标准中规定的骨接合植入物金属接骨板，在该标准规定金属接骨板有直型和异型两种，但不管是哪种类型的金属接骨板，接骨板均为板状，处于一个平面中。由于健康骨和移植骨的外表形状均有自然的生理弯曲，板状的接骨板并不能与骨的外表面完美贴合，所以固定不牢固。在手术中，医生可能根据连接部位的外形，使用手工工具对板状的接骨板进行矫形，但该矫形首先精度不够，仅能部分改善接骨板对骨外形的拟合。此外，钛板的矫形会造成钛金属晶格畸变，产生内裂纹，削弱钛板的连接强度。而且，手工矫形需要多次调整和尝试，延长了接骨手术的时间。这样，一方面让患者不舒服，不利于患者骨的恢复，同时金属接骨板的固定也不牢固。
此外，由于钛板的弹性模量远大于人骨，所以在受力情况下，接骨板和人骨的变形程度不同，接骨板和人骨之间会产生微滑移，相互摩擦造成患者疼痛。
在中国专利申请号为201420464816.5申请日为2014.8.18授权公告日为2015.1.14的专利文献中公开了一种踝下胫腓固定接骨板，其虽然产生了有益效果，但是该接骨板与患者骨接触的也为平面，因此，也是无法与患者骨完全拟合，同样产生上述技术问题。造成上述技术问题的主要原因是通过现有的制造技术难以成型与患者骨完全吻合的面。
发明内容
为解决上述技术问题，本发明提供了一种个性化接骨板及其制造方法。
解决上述技术问题的技术方案是：一种个性化接骨板，接骨板利用镁合金通过3D打印形成，接骨板与患者骨接触的表面与患者骨的形状拟合接触。
进一步的，接骨板与患者骨接触的表面分布有微孔和凹陷。
进一步的，接骨板与患者骨接触的表面的微孔和凹陷的孔径范围为500-5000微米。更进一步的，接骨板与患者骨接触的表面的微孔和凹陷的孔径范围为1000-3000微米。
进一步的，接骨板与患者骨接触的表面的微孔和凹陷的面积占所述表面的面积的比例范围为10%-80%。更进一步的，接骨板与患者骨接触的表面的微孔和凹陷的面积占所述表面的面积的比例范围为15-40%。
制造上述个性化接骨板的方法是：1）采用CTA扫描技术或MRI技术对患者骨部位进行立体造影，获得患者骨部位的三维数据；2）使用计算机辅助设计显示患者骨部位及确定接骨板形状尺寸以及对应连接方式；3）输出个性化接骨板数据，并使用金属粉末选区激光熔化3D打印机打印接骨板，所使用的镁合金的颗粒直径为15~45μm，且为球状。
进一步的，在步骤2）中，在与患者骨接触的接骨板表面，设计出微孔和凹陷。
进一步的，在步骤3）后，对3D打印完成的接骨板进行真空热处理。
本发明的有益效果是：
（1）由于接骨板与患者骨部位完全拟合，这样，当接骨板安装好后不容易发生位移，更加有利于患者骨的恢复，同时让患者感觉更加的舒服。此外，医生手术时不需要手工矫形和多次尝试，避免了接骨板矫形产生的力学缺陷，可以减少骨螺钉固定的数量，加快手术进程，降低患者痛苦。
（2）镁合金接骨板生物相容性好，杨氏模量（45GPa）与人骨（20GPa）相近，能有效缓解应力遮挡效应。此外，镁合金在人体内可逐渐被降解并吸收，可以避免二次手术取出，降低病人的痛苦及医疗成本。
（3）接骨板与患者骨接触的表面分布有微孔和凹陷，而上述微孔和凹陷可以吸收和储存体液，在接骨板和人骨之间形成润滑层，降低摩擦，减少患者疼痛。
（4）根据本发明的制造方法，采用CTA扫描技术和MRI技术能采集到精确的患者骨三维数据，根据该三维数据并通过3D打印能成型与患者骨完全拟合的接骨板，因此，成型接骨板的精度高，成本低，速度快。
（5）通过真空热处理，一方面调整接骨板基体组织结构，消除3D打印的缺陷，保证接骨板的力学性能。另一方面通过真空清除接骨板表面的未熔金属颗粒和气泡，提高接骨板的表面质量。
附图说明
图1为本发明个性化接骨板的正面示意图。
图2为本发明个性化接骨板的侧面示意图。
图3为本发明个性化接骨板与患者骨接触的表面层的放大示意图。
具体实施方式
下面结合附图和具体实施方式对本发明进行进一步详细说明。
如图1和图2所示，个性化接骨板1利用镁合金通过3D打印形成，所述接骨板1与患者骨接触的表面形成凹凸面或曲面，使得接骨板1与患者骨的形状拟合接触。所述接骨板1上有二个以上用于将接骨板1固定于患者骨的固定孔11。所述接骨板的厚度为0.5-4毫米，其厚度根据患者的需要确定。
如图3所示，接骨板1与患者骨接触的表面层中分布有多个微孔和凹陷3。微孔和凹陷3的孔径为D。
个性化接骨板的制造方法步骤为：
（1）采用CTA扫描技术或MRI技术对患者骨部位进行立体造影，获得患者骨部位的三维数据；（2）使用计算机辅助设计显示患者骨部位及确定接骨板形状尺寸以及对应连接方式；（3）输出个性化接骨板数据，并使用金属粉末选区激光熔化3D打印机打印接骨板，所使用的镁合金的颗粒直径为15~45μm，且为球状。
优选的，在步骤（2）中，在与患者骨接触的接骨板表面，设计出微孔和凹陷。
优选的，对3D打印获得的接骨板进行真空热处理。一方面，通过真空热处理，3D打印过程中，因为冷却速度快而产生的粗大枝状晶粒可以转换成能溶入统一基体的细小枝状晶粒，材料的各向异性弱化，力学性能提高。另一方面通过真空清除接骨板表面的未熔金属颗粒和气泡，提供接骨板的表面质量。
在本发明中，由于接骨板与患者骨部位完全拟合，这样，当接骨板安装好后不容易发生位移，更加有利于患者骨的恢复，同时让患者感觉更加的舒服。此外，医生手术时不需要手工矫形和多次尝试，避免了接骨板板矫形产生的力学缺陷，可以减少骨螺钉固定的数量，加快手术进程，降低患者痛苦。镁合金接骨板生物相容性好，杨氏模量（45GPa）与人骨（20GPa）相近，能有效缓解应力遮挡效应。此外，镁合金在人体内可逐渐被降解并吸收，可以避免二次手术取出，降低病人的痛苦及医疗成本。接骨板与患者骨接触的表面分布有微孔和凹陷，而上述微孔和凹陷可以吸收和储存体液，在接骨板和人骨之间形成润滑层，降低摩擦，减少患者疼痛。
根据本发明的制造方法，采用CTA扫描技术和MRI技术能采集到精确的患者骨三维数据，根据该三维数据并通过3D打印能成型与患者骨完全拟合的接骨板，因此，成型接骨板的精度高，成本低，速度快。进一步的，通过真空热处理，一方面调整接骨板基体组织结构，消除3D打印的缺陷，保证接骨板的力学性能。另一方面通过真空清除接骨板表面的未熔金属颗粒和气泡，提高接骨板表面质量。

Claims (9)

1.一种个性化接骨板，其特征在于：接骨板利用镁合金通过 3D 打印形成，所述接骨板与患者骨接触的表面与患者骨的形状拟合接触。
2.根据权利要求 1 所述的一种个性化接骨板，其特征在于：所述接骨板与患者骨接触的表面分布有微孔和凹陷。
3.根据权利要求 2 所述的一种个性化接骨板，其特征在于：所述接骨板与患者骨接触的表面的微孔和凹陷的孔径范围为 500-5000 微米。
4.根据权利要求 3 所述的一种个性化接骨板，其特征在于：所述接骨板与患者骨接触的表面的微孔和凹陷的孔径范围为 1000-3000 微米。
5.根据权利要求 2 所述的一种个性化接骨板，其特征在于：所述接骨板与患者骨接触的表面的微孔和凹陷的面积占所述表面的面积的比例范围为 10%-80% 。
6.根据权利要求 5 所述的一种个性化接骨板，其特征在于：所述接骨板与患者骨接触的表面的微孔和凹陷的面积占所述表面的面积的比例范围为 15-40% 。
7.一种个性化接骨板的制造方法，其特征在于包括有以下步骤： 1 ）采用 CTA 扫描技术或 MRI 技术对患者骨部位进行立体造影，获得患者骨部位的三维数据； 2 ）使用计算机辅助设计显示患者骨部位及确定接骨板形状尺寸以及对应连接方式； 3 ）输出个性化接骨板数据，并使用金属粉末选区激光熔化 3D 打印机打印接骨板，所使用的镁合金的颗粒直径为 15~45 μ m ，且为球状。
8.根据权利要求 7 所述的一种个性化接骨板的制造方法，其特征在于：在步骤 2 ）中，在与患者骨接触的接骨板表面，设计出微孔和凹陷。
9.根据权利要求 7 所述的一种个性化接骨板的制造方法，其特征在于：在步骤 3 ）后，对 3D 打印完成的接骨板进行真空热处理。
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