CN103315831A - 一种具有高活动度的一体化人工颈椎间盘假体 - Google Patents

一种具有高活动度的一体化人工颈椎间盘假体 Download PDF

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CN103315831A
CN103315831A CN2013102239281A CN201310223928A CN103315831A CN 103315831 A CN103315831 A CN 103315831A CN 2013102239281 A CN2013102239281 A CN 2013102239281A CN 201310223928 A CN201310223928 A CN 201310223928A CN 103315831 A CN103315831 A CN 103315831A
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汪涛
高亚军
李敏
王晨玥
王阳阳
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Nanjing University of Aeronautics and Astronautics
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Abstract

本发明涉及一种具有高活动度的一体化人工颈椎间盘假体，本发明所述的本体为上下端板一体化的Ω型非接触的弹性结构，其中：本体的材质为弹性模量55~90Gpa和屈服强度≥600MPa的钛合金；本体的上下端板外表面上分别对称设置人字形双向止退倒齿或菱形双向止退倒齿；本体的下端板长度为10~16mm、上端板长度比下端板长度短1mm、上下端板的间距为2~3.5mm；本体的总体高度为5~8mm，本体后端弯曲段厚度为0.5~0.9mm。本发明的一体化人工颈椎间盘假体完全能够满足长寿命抗疲劳性能的要求，极大地提高了患者病变节段的活动度，且实现方法科学合理、效果显著和优势明显，有利于提高人民群众的健康水平。

Description

一种具有高活动度的一体化人工颈椎间盘假体
技术领域
本发明涉及一种人工颈椎间盘假体，特别是涉及一种具有高活动度的一体化人工颈椎间盘假体。 
背景技术
人工颈椎间盘置换术能在进行脊髓减压并提供稳定的同时保持手术节段的生理活动度，更加符合颈椎活动的生物力学特点，可避免邻近节段椎间盘退变加速，为颈椎病的外科治疗提供了一个全新的医术。目前临床上主要应用的人工颈椎间盘有Bryan假体Prodisc-C假体Prestige假体PCM假体等。虽然各种假体材料、形态各异，但这些假体普遍存在以下缺点：一是常见的人工颈椎间盘产品结构繁琐、手术相对复杂，易造成异位骨化问题。由于现有的产品不能很好地恢复和维持椎间隙的高度、保持节段稳定性，而引起非典型性骨化；二是常见的人工颈椎间盘产品抗疲劳和抗磨损性能差，疲劳断裂、疲劳磨损导致假体易产生磨损颗粒，磨损碎粒可引起无菌性骨质吸收，导致假体置换失败，术后易发生并发症；三是公知的弹性人工颈椎间盘假体选用的材质为钴铬合金、钛合金Ti6Al4V或纯钛，因这些材质弹性模量的不足，使得假体在植入颈椎椎间隙后均不能够很好地恢复正常颈椎节段的运动功能。 
中国专利申请200620112142公开了一种“弹片式人工椎间盘”，虽然该方案采用了呈马蹄形的弹片，并在弹片的上下侧分别设置有复数个倒勾等措施来实现与患者正常的椎间盘配合运作的目的，但是还存在以下主要不足：一是从生物物理学角度来看，该弹片的上下侧呈对称结构，既不能满足人体颈椎的生理前凸，也不能很好的填充椎间隙，使得椎间盘的屈曲、伸展运动和压缩减震功能受到限制，所以马蹄形弹片还不是最佳的弹性体；二是弹片的上下侧分别设置的倒勾仅具有单向止退功能，且易造成假体以及椎体表面的应力集中；三是对弯曲弧度和高度缺乏精密性设计手段，使得植入假体不能很好地恢复和维持椎间隙的高度、保持节段的稳定性；四是现有一体化弹片式人工颈椎间盘植入后节段活动度与正常颈椎节段活动度相差较大，不能够很好地恢复正常颈椎节段的运动功能。 
综上所述，如何克服现有技术的不足已成为当今人工植入假体技术领域中亟待解决的重点难题之一。 
发明内容
本发明的目的是为克服现有技术的不足而提供一种具有高活动度的一体化人工颈椎间盘假体，本发明的一体化人工颈椎间盘假体能够满足长寿命抗疲劳性能的要求，极大地提高患者病变节段的活动度，有利于提高人民群众的健康水平。 
根据本发明提出的一种具有高活动度的一体化人工颈椎间盘假体，它包括本体，其特征在于该本体为上下端板一体化的Ω型非接触的弹性结构，其中：本体的材质为弹性模量55～90Gpa和屈服强度≥600MPa的钛合金；本体的上下端板外表面上分别对称设置人字形双向止退倒齿或菱形双向止退倒齿；本体的下端板长度为10～16mm、本体的上端板长度比下端板长度短1mm、上下端板的间距为2～3.5mm；本体的总体高度为5～8mm。本发明进一步的优选方案在于所述的本体的后端弯曲段高度为3.5～6.5mm、后端弯曲段厚度为0.5～0.9mm，后端弯曲段最佳厚度为0.6～0.8mm。 
本发明的实现原理是：首先将一体化人工颈椎间盘与去除C5-C6椎体节段的椎间盘，在CAD造型软件中进行装配得到所需要的颈椎三维几何模型；其次将得到的颈椎三维几何模型导入有限元分析软件，定义单元类型、赋予各部分植入假体材质属性和划分网格，得到一体化人工颈椎间盘C5-C6节段颈椎的有限元模型；然后对一体化人工颈椎间盘的下颈椎相邻椎体节段模型进行有限元模拟分析，对前屈、后伸以及侧屈载荷下的应力及颈椎节段活动度进行分析比较，得到模拟结果；最后优选模拟结果，确定本体为上下端板一体化的Ω型非接触的弹性结构、本体的上下端板外表面上分别对称设置人字形双向止退倒齿或菱形双向止退倒齿、本体的材质为弹性模量55～90Gpa和屈服强度≥600MPa的钛合金、本体的下端板长度为10～16mm、本体的上端板长度比下端板长度短1mm、上下端板的间距为2～3.5mm、本体的总体高度为5～8mm以及本体的后端弯曲段高度为3.5～6.5mm、后端弯曲段厚度为0.5～0.9mm，该在条件下的植入假体后节段的前屈活动度及侧屈活动度接近患者正常颈椎该节段活动度的50%～70%、该假体后伸活动度达到患者正常颈椎该节段活动度的80%～90%。 
本发明与现有技术相比其显著优点在于：一是本发明为一体化无移动部件的Ω型非接触的弹性结构的人工颈椎间盘假体形状，其材质为弹性模量55～90Gpa和屈服强度≥600MPa的钛合金，从生物物理学角度来看，完全能够满足长寿命抗疲劳性能的要求，极大地提高了患者病变节段的活动度；二是本体上下端板外表面上设置了与上下椎骨锚固的双向止退倒齿，保证了术后节段的稳定，防止了假体脱出；三是通过对植入假体的下颈椎相邻椎体节段模型进行有限元模拟，以及对前屈、后伸以及侧屈载荷下的应力及颈椎节段活动度进行有限元模拟，优选确定本体的材质和结构造型，极大地保留了椎间盘的屈曲、伸展运动和压缩减震功 能，为仿真创造了新的选择方法，优势特别明显；四是本发明试验结果表明，植入该假体后节段的前屈活动度及侧屈活动度接近患者正常颈椎该节段活动度的50%～70%，而后伸活动度达到患者正常颈椎该节段活动度的80%～90%，效果显著，有利于提高人民群众的健康水平。 
附图说明
图1是本发明提出的一种带有人字形双向止退倒齿的一体化人工颈椎间盘假体的结构示意图。 
图2是本发明提出的一种带有菱形双向止退倒齿的一体化人工颈椎间盘假体的结构示意图。 
图3为植入Ti13Nb13Zr钛合金人工颈椎间盘假体的C5-C6单节段有限元模型前屈载荷下的等效应力分布云图。 
图4为Ti13Nb13Zr钛合金人工颈椎间盘假体的等效应力分布云图。 
图5为植入Ti6Al4V钛合金人工颈椎间盘假体的C5-C6单节段有限元模型前屈载荷下的等效应力分布云图。 
图6为Ti6Al4V钛合金人工颈椎间盘假体的等效应力分布云图。 
图7为植入纯钛人工颈椎间盘假体的C5-C6单节段有限元模型前屈载荷下的等效应力分布云图。 
图8为纯钛人工颈椎间盘假体的等效应力分布云图。 
具体实施方式
下面结合附图和具体实施方式对本发明作进一步的详细说明。 
结合图1和图2，本发明提出的一种具有高活动度的一体化人工颈椎间盘假体，它包括上下端板一体化的Ω型非接触的弹性结构的本体（1），其中：本体（1）的材质为弹性模量55～90Gpa和屈服强度≥600MPa的钛合金；本体（1）的上下端板外表面上分别对称设置人字形双向止退倒齿（2）或菱形双向止退倒齿（3）；本体（1）的下端板长度为10～16mm、本体（1）的上端板长度比下端板长度短1mm、上下端板的间距为2～3.5mm；本体（1）的总体高度为5～8mm；本体（1）的后端弯曲段高度为3.5～6.5mm、后端弯曲段厚度为0.5～0.9mm，后端弯曲段最佳厚度为0.6～0.8mm。 
本发明提出的一种具有高活动度的一体化人工颈椎间盘假体是通过以下方法实现的，其具体步骤如下： 
步骤一，将一体化人工颈椎间盘与去除C5-C6椎体节段的椎间盘，在CAD造型软件中 进行装配得到所需要的颈椎三维几何模型； 
步骤二，将步骤一得到的颈椎三维几何模型导入有限元分析软件，定义单元类型、赋予各部分植入假体材质属性和划分网格，得到一体化人工颈椎间盘C5-C6节段颈椎的有限元模型； 
步骤三，在步骤二的基础上，对一体化人工颈椎间盘的下颈椎相邻椎体节段模型进行有限元模拟分析，对前屈、后伸以及侧屈载荷下的应力及颈椎节段活动度进行分析比较，得到模拟结果； 
步骤四，在步骤三的基础上，优选模拟结果，确定本体（1）为上下端板一体化的Ω型非接触的弹性结构、本体（1）的上下端板外表面上分别对称设置人字形双向止退倒齿（2）或菱形双向止退倒齿（3）、本体（1）的材质为弹性模量55～90Gpa和屈服强度≥600MPa的钛合金、本体（1）的下端板长度为10～16mm、本体（1）的上端板长度比下端板长度短1mm、上下端板的间距为2～3.5mm、本体（1）的总体高度为5～8mm以及本体（1）的后端弯曲段高度为3.5～6.5mm、后端弯曲段厚度为0.5～0.9mm； 
步骤五，在步骤四的基础上，制造钛合金一体化人工颈椎间盘试验件，在模拟人C5-C6节段颈椎的载荷条件下进行静力学加载试验，植入假体后节段的前屈活动度及侧屈活动度接近患者正常颈椎该节段活动度的50%～70%、该假体后伸活动度达到患者正常颈椎该节段活动度的80%～90%。 
以下结合图3至图8，进一步说明实施本发明的几个关键操作步骤的具体实施例。 
实施例1：建立一体化人工颈椎间盘C5-C6节段颈椎的有限元模型。有限元模型中的本体（1）为上下端板一体化的Ω型非接触的弹性结构，该本体（1）上下端板外表面上分别对称设有人字形双向止退倒齿（2），本体（1）的后端弯曲段厚度为0.8mm，本体（1）的材质分别选用近β型Ti13Nb13Zr钛合金、Ti6Al4V钛合金或纯钛，其中：近β型Ti13Nb13Zr钛合金弹性模量为60GPa；纯钛材料弹性模量为114GPa；Ti6Al4V钛合金弹性模量为110GPa。 
在前屈载荷下进行模拟分析，所得结果如表1所示。 
表1前屈载荷下选用不同本体（1）材质的有限元模型模拟结果 
结合图3至图8并参见表1，前屈载荷下选用纯钛材料的本体最大Von Mises应力为394.640MPa，已接近选用纯钛材质的屈服极限，而选用近β型Ti13Nb13Zr钛合金和TC4钛合金两种材质的本体在前屈载荷下最大Von Mises应力均在两种材质的屈服极限之下；前屈载荷下选用TC4钛合金材质的本体的最大Von Mises应力为398.623MPa，由于纯钛材质和TC4钛合金弹性模量相当，故选用两种材质的本体的最大Von Mises应力、最大位移、节段活动度均接近；选用近β型Ti13Nb13Zr钛合金材质的本体术后前屈载荷下的节段活动度为2.506°，远大于选用TC4钛合金材质以及纯钛材质的本体术后前屈载荷下的节段活动度，且接近正常颈椎该节段活动度的50%。 
在后伸以及侧屈载荷下进行模拟分析。模拟结果表明，两种载荷下本体（1）最大Von Mises应力均未超过所用材质的屈服强度；后伸载荷下选用近β型Ti13Nb13Zr钛合金材质的假体术后节段活动度为3.232°，达到正常颈椎该节段活动度的85%；侧屈载荷下选用近β型Ti13Nb13Zr钛合金材质的假体术后节段活动度为1.194°，接近正常颈椎该节段活动度的60%。后伸和侧屈载荷下选用近β型Ti13Nb13Zr钛合金材质的假体术后的节段活动度均大于选用TC4钛合金材质以及纯钛材质的假体术后的节段活动度。 
通过对以上三种载荷下的模拟结果进行比较分析，近β型Ti13Nb13Zr钛合金材料是满足一体化Ω型结构人工颈椎间盘高活动度要求的假体材料。 
在上述研究基础上，制造钛合金一体化人工颈椎间盘试验件，在模拟人C5-C6节段颈椎的载荷条件下进行静力学加载的试验结果与数值模拟结果吻合。 
实施例2：建立一体化人工颈椎间盘C5-C6节段颈椎的有限元模型。有限元模型中的本体（1）为上下端板一体化的Ω型非接触的弹性结构，该本体（1）上下端板外表面上分别对称设有人字形双向止退倒齿，本体（1）的后端弯曲段厚度为0.8mm，本体（1）选用β型钛合金Ti-29Nb-13Ta-4.6Zr，其强度和疲劳寿命、耐磨性和力学性能都接近于TC4钛合金，但弹性模量为70GPa比TC4钛合金低得多。在前屈、后伸以及侧屈载荷下进行模拟分析，所得结果与选用TC4钛合金材质以及纯钛材质的假体的有限元节段模拟分析结果进行比较。结果表明，弹性模量为70GPa的β型钛合金Ti-29Nb-13Ta-4.6Zr是满足一体化Ω型结构人工颈椎间盘高活动度要求的适宜假体材质。 
在上述研究基础上，制造钛合金一体化人工颈椎间盘试验件，在模拟人C5-C6节段颈椎的载荷条件下进行静力学加载的试验结果与数值模拟结果吻合。 
实施例3：选取以下规格的一体化Ω型非接触的弹性结构人工颈椎间盘：本体（1）的下端板长度为14mm、宽度为16mm、上下端板间距为3.3mm；本体（1）后端总体高度为6.0mm；人字形双向止退倒齿（2）的最大高度选择为0.8mm。 
分别建立植入本体（1）后端弯曲段厚度为0.5mm、0.6mm、0.8mm和0.9mm的一体化Ω型非接触的弹性结构人工颈椎间盘C5-C6节段颈椎的有限元模型，本体（1）材质均选用生物医用β型钛合金Ti13Nb13Zr，运用有限元模拟分析方法在前屈、后伸以及侧屈三种载荷下进行模拟分析，计算求得人工颈椎间盘本体（1）最大VonMises应力、最大位移以及术后节段活动度，如表2所示。 
表2三种载荷下不同本体（1）后端弯曲段厚度有限元模型的模拟结果 
Figure 2013102239281100002DEST_PATH_IMAGE002
由表2可看出，前屈载荷下本体（1）后端弯曲段厚度为0.6mm的假体术后节段活动度为3.003°，接近正常颈椎该节段活动度的60%；后伸载荷下本体（1）后端弯曲段厚度为0.6mm的假体术后节段活动度为3.846°，达到正常颈椎该节段活动度的90%；侧屈载荷下本体（1）后端弯曲段厚度为0.6mm的假体术后节段活动度为1.784°，接近正常颈椎该节段活动度的70%。通过该选择方法认为本体（1）后端弯曲段最佳厚度为0.6～0.8mm的一体化人工颈椎间盘能够满足假体高活动度的性能要求。 
在上述研究基础上，制造钛合金一体化人工颈椎间盘试验件，在模拟人C5-C6节段颈椎的载荷条件下进行静力学加载的试验结果与数值模拟结果吻合。 
本发明经反复试验验证，取得了满意的应用效果。 

Claims (3)

1.一种具有高活动度的一体化人工颈椎间盘，它包括本体（1），其特征在于该本体（1）为上下端板一体化的Ω型非接触的弹性结构，其中：本体（1）的材质为弹性模量55~90Gpa和屈服强度≥600MPa的钛合金；本体（1）的上下端板外表面上分别对称设置人字形双向止退倒齿（2）或菱形双向止退倒齿（3）；本体（1）的下端板长度为10~16mm、本体（1）的上端板长度比下端板长度短1mm、上下端板的间距为2~3.5mm；本体（1）的总体高度为5~8mm。
2.根据权利要求1所述的一种具有高活动度的一体化人工颈椎间盘假体，其特征在于本体（1）的后端弯曲段高度为3.5~6.5mm、后端弯曲段厚度为0.5~0.9mm。
3.根据权利要求1或2所述的一种具有高活动度的一体化人工颈椎间盘假体，其特征在于本体（1）的后端弯曲段高度为3.5~6.5mm、后端弯曲段厚度为0.6~0.8mm。
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