CN113367853A - 一种复合结构股骨假体的制作方法 - Google Patents
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Abstract
本发明公开一种复合结构股骨假体的制作方法,其特征在于:所述的方法按照如下步骤依次进行:股骨假体的三维重建,建立股骨假体及连接件的数学模型,股骨假体的网格划分,不同生物力学环境下的有限元分析,确定评价指标并优化选择,利用3D打印技术制作股骨假体。利用该方法所制备的复合结构的股骨假体,既具有较高的抗拉性能和耐腐蚀性能,又与真骨的物理性质十分接近。
Description
技术领域
本发明涉及一种假体的制作方法,具体是一种复合结构股骨假体的制作方法。
背景技术
一些关节炎、外伤骨折、先天性髋关节发育不良等临床治疗方案,通常需要采用半髋或全髋股骨假体置换术。目前市场上常用的股骨假体有金属、陶瓷、有机高分子材料等,然而很少有材料可以同时满足复杂关节置换术所需的生物相容性和与真骨材料力学性质接近这两个特点。
钛合金假体具有较好的抗拉、耐腐蚀性,但是物理性质与真骨差别很大,聚醚醚酮(polyether-ether-ketone,PEEK)假体与真骨的物理性质,特别是弹性模量十分接近,但是抗拉耐腐蚀性不理想,很难与真骨融合。也就是说上述两种材料都难以满足股骨假体置换的需求。因此现在需要一种能够解决上述问题的方法。
发明内容
本发明是为了解决现有技术所存在的上述不足,提出一种制作复合结构股骨假体的方法,利用该方法所制备的复合结构的股骨假体,既具有较高的抗拉性能和耐腐蚀性能,又与真骨的物理性质十分接近。
本发明的技术解决方案是:一种复合结构股骨假体的制作方法,其特征在于:所述的方法按照如下步骤依次进行:股骨假体的三维重建,建立股骨假体及连接件的数学模型,股骨假体的网格划分,不同生物力学环境下的有限元分析,确定评价指标并优化选择,利用3D打印技术制作股骨假体,
所述股骨假体的三维重建步骤为:将患者的DICOM格式的CT图像导入到三维重建软件中进行三维重建操作,依次经过体绘制分割,阈值分割,简便种子点,团块分离,二维编辑和网格光滑步骤,分别得到患者对侧正常股骨的皮质骨和松质骨的模型,并且记录数据;
所述建立股骨假体及连接件的数学模型步骤为:建立股骨头假体头部1的数学模型、建立股骨头假体尾部2的数学模型、在股骨头假体尾部2的数学模型的基础上建立连接件3的数学模型,对建立的数学模型进行布尔运算,
其中建立股骨头假体头部1的数学模型时,根据患者对侧健康骨模型,建立股骨头假体头部1,具体步骤包括组合、切除拉伸、建立基准面和分割,最终获得股骨头假体头部1的数学模型,股骨头假体头部1的上部呈球型结构,与髋臼配适,
建立股骨头假体尾部2的数学模型时,根据患者对侧健康骨模型,建立股骨头假体尾部2,具体步骤包括组合、切除拉伸、建立基准面和分割,需保证股骨头假体尾部2的上部与股骨头假体头部1的下部形状、大小以及建模位置均完全吻合,
所述的连接件3的中部为圆柱体状,在圆柱体的两端分别设置有一个十字架结构,
在股骨头假体头部1,股骨头假体尾部2和连接件3建立完毕后,利用三维重建软件模拟手术状况,切除正常的股骨头以及与假体部分重合的松质骨上端,并根据各部位之间的关系分别进行布尔运算,
而每组需要进行的布尔运算有:股骨头假体头部1与假体连接件3进行布尔减运算,头部镂空,
股骨头假体尾部2与假体连接件3进行布尔加运算,尾部突出,
皮质骨分别与股骨头假体头部1、股骨头假体尾部2进行布尔减运算;
股骨头假体尾部2与松质骨进行布尔减运算;
所述股骨假体的网格划分步骤为:将做好的股骨皮质骨,松质骨、股骨头假体头部1以及股骨头假体尾部2导入到网格划分软件中进行网格划分,划分面网格,检查网格空洞、并进行修复,然后进行体网格划分操作,得到四面体单元网格划的模型,随后导出INP文件并保存;
所述不同生物力学环境下的有限元分析步骤为:将划分网格完成的文件导入到有限元分析软件中,并且将皮质骨,松质骨、股骨头假体头部1和股骨头假体尾部2导入到同一个模块中,上述各部分材料属性按照如下设定:股骨头假体头部1的材料为聚醚醚酮,弹性模量为4100MPa,泊松比为0.4,松质骨的弹性模量为500MPa,泊松比为0.3,股骨头假体尾部2的材料为钛合金,弹性模量为110000MPa,泊松比为0.3,皮质骨的弹性模量为16000MPa,泊松比为0.3,连接件的材料为钛合金,弹性模量为110000MPa,泊松比为0.3,
在添加载荷之前先将股骨处受力简化,并分别分析两种状态下的受力情况,即双腿静止站立以及缓慢行走两种状态,
创建一个任务,然后提交运算,并在运行完成之后,选择可视化,显示云图,选择最大应力与总应力的结果导出,分别记录骨股骨头假体头部1与股骨头假体尾部2的元素个数;
所述确定评价指标并优化选择步骤为:从双腿静止站立姿态下得到的有限元分析结果中,挑选受力均匀且最大应力最小的模型,从缓慢行走姿态下得到的有限元分析结果中,挑选受力均匀且最大应力最小的模型;
所述利用3D打印技术制作股骨假体步骤为:1.将制作好的建立股骨头假体头部1、股骨头假体尾部2以及连接件3的数学模型,导入多材料一体成型3D打印机控制软件,按熔点从高到低的顺序转换为3D打印机可识别的信号并形成文件,
将peek材料、钛合金材料装入送料器,预热两个打印头,使其温度达到各材料熔点,将文件输入主机板准备开始打印,
材料切换过程由主机板传输的信号控制,当钛合金模型部分打印完成时,冷却风扇会将工件温度降低到连接材料熔点温度以下,此时主机板传输信号切换打印头并开始打印连接部分,之后切换至peek材料,切换过程同上,直至打印完成。
本发明同现有技术相比,具有如下优点:
本发明公开了一种新型结构形式的复合型股骨假体,这种假体由股骨头假体头部、股骨头假体尾部以及将二者连接为一体结构的连接件组成,其中股骨头假体的头部部分采用钛合金制成,而尾部部分则采用PEEK材料制成,该方法经过股骨假体的三维重建,建立股骨假体及连接件的数学模型,股骨假体的网格划分,不同生物力学环境下的有限元分析,确定评价指标并优化选择,利用3D打印技术制作股骨假体等步骤,利用3D打印的方式完成复合式股骨假体的制作,所获得的股骨假体既具有较高的抗拉性能和耐腐蚀性能,又与真骨的物理性质十分接近,与传统材质的股骨假体相比,更加适合于股骨假体的置换。
附图说明
图1是本发明实施例中双足静止站立状态下股骨所受最大应力、平均应力与连接件长度、直径、假体截面移动距离之间的关系图。
图2是本发明实施例中缓慢行走状态下股骨所受最大应力、平均应力与连接件长度、直径、假体截面移动距离之间的关系图。
图3是本发明所述方法所制备的复合股骨假体的结构。
具体实施方式
下面将结合附图说明本发明的具体实施方式。如图1、图2、图3所示:一种复合结构股骨假体的制作方法,按照如下步骤依次进行:股骨假体的三维重建,建立股骨假体及连接件的数学模型,股骨假体的网格划分,不同生物力学环境下的有限元分析,确定评价指标并优化选择,利用3D打印技术制作股骨假体,
所述股骨假体的三维重建步骤为:将患者DICOM格式的CT图像导入到三维重建软件中进行三维重建操作,依次经过体绘制分割,阈值分割,简便种子点,团块分离,二维编辑和网格光滑步骤,分别得到患者对侧正常股骨的皮质骨和松质骨的模型,并且记录数据;
所述建立股骨假体及连接件的数学模型步骤为:建立股骨头假体头部1的数学模型、建立股骨头假体尾部2的数学模型、建立连接件3的数学模型,对建立的数学模型进行布尔运算,
其中建立股骨头假体头部1的数学模型时,根据患者对侧健康骨模型,建立股骨头假体头部1,具体步骤包括组合、切除拉伸、建立基准面和分割,最终获得股骨头假体头部1的数学模型,股骨头假体头部1的上部呈球型结构,该球形的直径为 45mm±0.6,与髋臼配适,头部整体长度61mm±0.5,
建立股骨头假体尾部2的数学模型时,根据患者对侧健康骨模型,建立股骨头假体尾部2,具体步骤包括组合、切除拉伸、建立基准面和分割,需保证股骨头假体尾部2的上部与股骨头假体头部1的下部形状、大小以及建模位置均完全吻合,
所述的连接件3的中部为圆柱体状,在圆柱体的两端分别设置有一个十字架结构,所述的十字架结构由两根直径为6mm,长度为14mm的柱体形成,两个十字架结构之间的距离为30mm;
连接件3的主要参数有两十字交叉结构的距离(即总体长度)、组成连接件各圆柱
的直径以及最初建立模型的截面位置(记为0)。截面位置改变为正时,截面向股骨头假体头
部1方向移动;为负时,截面向股骨头假体头部1的反方向移动。连接件3设计时只改变其中
一个参数,其余参数不变。连接件3有三种类数变化,每类参数变化会有5个实验模型,各参
数变化情况如表1所示。
连接件长度(mm) | 连接件直径(mm) | 连接件位置(最初设计位置为0mm) |
26 | 5.6 | -4 |
28 | 5.8 | -2 |
30 | 6.0 | 0 |
32 | 6.2 | 2 |
34 | 6.4 | 4 |
表1
在股骨头假体头部1,股骨头假体尾部2和连接件3建立完毕后,利用三维重建软件模拟手术状况,切除正常的股骨头以及与假体部分重合的松质骨上端,并根据各部位之间的关系分别进行布尔运算,
而每组需要进行的布尔运算有:股骨头假体头部1与假体连接件3进行布尔减运算,头部镂空,
股骨头假体尾部2与假体连接件3进行布尔加运算,尾部突出,
皮质骨分别与股骨头假体头部1、股骨头假体尾部2进行布尔减运算;
股骨头假体尾部2与松质骨进行布尔减运算;
所述股骨假体的网格划分步骤为:将做好的股骨皮质骨,松质骨、股骨头假体头部1以及股骨头假体尾部2导入到网格划分软件中进行网格划分,划分面网格,检查网格空洞、并进行修复,然后进行体网格划分操作,得到四面体单元网格划的模型,随后导出INP文件并保存;
所述不同生物力学环境下的有限元分析步骤为:将划分网格完成的文件导入到有
限元分析软件中,并且将皮质骨,松质骨、股骨头假体头部1和股骨头假体尾部2导入到同一
个模块中(连接件3属于股骨头假体尾部的一部分,其材质与股骨头假体尾部2相同),上述
各部分材料属性按照如表2设定:
材料 | 弹性模量(MPa) | 泊松比 | |
股骨头假体头部 | 聚醚醚酮(peek) | 4100 | 0.4 |
松质骨 | 松质骨 | 500 | 0.3 |
股骨头假体尾部 | 钛合金 | 110000 | 0.3 |
皮质骨 | 皮质骨 | 16000 | 0.3 |
表2
在添加载荷之前先将股骨处受力简化,并分别分析两种状态下的受力情况,即双腿静止站立以及缓慢行走两种状态,
一般来说,60kg的患者双腿静止站立时股骨头假体头部1受总力为196N,缓慢行走时,股骨头假体头部1受力940.8N,外展肌力2822.4N,
创建一个任务,然后提交运算,并在运行完成之后,选择可视化,显示云图,选择最大应力与总应力的结果导出,分别记录骨股骨头假体头部1与股骨头假体尾部2的element个数;
所述确定评价指标并优化选择步骤为:从双腿静止站立姿态下得到的有限元分析结果中(如图2所示),挑选受力均匀且最大应力最小的模型,比较各组的数据之后发现,假体截面移动距离为0所在的皮质骨所受最大应力与平均应力都是最小的,为最优化模型;
从缓慢行走姿态下得到的有限元分析结果中(如图3所示),挑选受力均匀且最大应力最小的模型,比较各组数据后发现,当截面向股骨头上部移动2mm骨的最大应力最小。
通过实验数据可以发现,患者在45%步态时刻,初次设计的连接件3(连接件长度为30mm、直径为6mm、截面位移距离为0mm)的骨的平均应力都为最小值即8.3411MPa,此参数的连接件3在长度变化上骨的最大应力同样是最小值,而在直径和截面位移距离改变的条件下,虽然骨的最大应力不是最小值,但是数据适中,在合理的参考范围,所以以此参数作为连接件设计参数,并与假体头部及尾部组合为股骨假体,能够使患者术后正常站立和步行,可以满足其日常生活。
所述利用3D打印技术制作股骨假体步骤为:1.将制作好的建立股骨头假体头部1、股骨头假体尾部2以及连接件3的数学模型,导入多材料一体成型3D打印机控制软件,按熔点从高到低的顺序转换为3D打印机可识别的信号并形成文件,
将peek材料、钛合金材料装入送料器,预热两个打印头,使其温度达到各材料熔点,将文件输入主机板准备开始打印,
材料切换过程由主机板传输的信号控制,当钛合金模型部分打印完成时,冷却风扇会将工件温度降低到连接材料熔点温度以下,此时主机板传输信号切换打印头并开始打印连接部分,之后切换至peek材料,切换过程同上,直至打印完成。
Claims (1)
1.一种复合结构股骨假体的制作方法,其特征在于:所述的方法按照如下步骤依次进行:股骨假体的三维重建,建立股骨假体及连接件的数学模型,股骨假体的网格划分,不同生物力学环境下的有限元分析,确定评价指标并优化选择,利用3D打印技术制作股骨假体,
所述股骨假体的三维重建步骤为:将患者的DICOM格式的CT图像导入到三维重建软件中进行三维重建操作,依次经过体绘制分割,阈值分割,简便种子点,团块分离,二维编辑和网格光滑步骤,分别得到患者对侧正常股骨的皮质骨和松质骨的模型,并且记录数据;
所述建立股骨假体及连接件的数学模型步骤为:建立股骨头假体头部(1)的数学模型、建立股骨头假体尾部(2)的数学模型、在股骨头假体尾部(2)的数学模型的基础上建立连接件(3)的数学模型,对建立的数学模型进行布尔运算,
其中建立股骨头假体头部(1)的数学模型时,根据患者对侧健康骨模型,建立股骨头假体头部(1),具体步骤包括组合、切除拉伸、建立基准面和分割,最终获得股骨头假体头部(1)的数学模型,股骨头假体头部(1)的上部呈球型结构,与髋臼配适,
建立股骨头假体尾部(2)的数学模型时,根据患者对侧健康骨模型,建立股骨头假体尾部(2),具体步骤包括组合、切除拉伸、建立基准面和分割,需保证股骨头假体尾部(2)的上部与股骨头假体头部(1)的下部形状、大小以及建模位置均完全吻合,
所述的连接件(3)的中部为圆柱体状,在圆柱体的两端分别设置有一个十字架结构,
在股骨头假体头部(1),股骨头假体尾部(2)和连接件(3)建立完毕后,利用三维重建软件模拟手术状况,切除正常的股骨头以及与假体部分重合的松质骨上端,并根据各部位之间的关系分别进行布尔运算,
而每组需要进行的布尔运算有:股骨头假体头部(1)与假体连接件(3)进行布尔减运算,头部镂空,
股骨头假体尾部(2)与假体连接件(3)进行布尔加运算,尾部突出,
皮质骨分别与股骨头假体头部(1)、股骨头假体尾部(2)进行布尔减运算;
股骨头假体尾部(2)与松质骨进行布尔减运算;
所述股骨假体的网格划分步骤为:将做好的股骨皮质骨,松质骨、股骨头假体头部(1)以及股骨头假体尾部(2)导入到网格划分软件中进行网格划分,划分面网格,检查网格空洞、并进行修复,然后进行体网格划分操作,得到四面体单元网格划的模型,随后导出INP文件并保存;
所述不同生物力学环境下的有限元分析步骤为:将划分网格完成的文件导入到有限元分析软件中,并且将皮质骨,松质骨、股骨头假体头部(1)和股骨头假体尾部(2)导入到同一个模块中,上述各部分材料属性按照如下设定:股骨头假体头部(1)的材料为聚醚醚酮,弹性模量为4100MPa,泊松比为0.4,松质骨的弹性模量为500MPa,泊松比为0.3,股骨头假体尾部2的材料为钛合金,弹性模量为110000MPa,泊松比为0.3,皮质骨的弹性模量为16000MPa,泊松比为0.3,连接件的材料为钛合金,弹性模量为110000MPa,泊松比为0.3,
在添加载荷之前先将股骨处受力简化,并分别分析两种状态下的受力情况,即双腿静止站立以及缓慢行走两种状态,
创建一个任务,然后提交运算,并在运行完成之后,选择可视化,显示云图,选择最大应力与总应力的结果导出,分别记录骨股骨头假体头部(1)与股骨头假体尾部(2)的元素个数;
所述确定评价指标并优化选择步骤为:从双腿静止站立姿态下得到的有限元分析结果中,挑选受力均匀且最大应力最小的模型,从缓慢行走姿态下得到的有限元分析结果中,挑选受力均匀且最大应力最小的模型;
所述利用3D打印技术制作股骨假体步骤为:1.将制作好的建立股骨头假体头部(1)、股骨头假体尾部(2)以及连接件(3)的数学模型,导入多材料一体成型3D打印机控制软件,按熔点从高到低的顺序转换为3D打印机可识别的信号并形成文件,
将peek材料、钛合金材料装入送料器,预热两个打印头,使其温度达到各材料熔点,将文件输入主机板准备开始打印,
材料切换过程由主机板传输的信号控制,当钛合金模型部分打印完成时,冷却风扇会将工件温度降低到连接材料熔点温度以下,此时主机板传输信号切换打印头并开始打印连接部分,之后切换至peek材料,切换过程同上,直至打印完成。
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