CN116965899A - 一种基于3d打印的肿瘤膝关节假体多孔髓内针及其设计方法 - Google Patents
一种基于3d打印的肿瘤膝关节假体多孔髓内针及其设计方法 Download PDFInfo
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Abstract
本发明提供了一种肿瘤膝关节假体多孔髓内针及其设计方法,包括:1.设计了不同孔隙率的Gyroid多孔结构模型,3D打印后通过准静态压缩试验分析得到适合作为骨植入体的孔隙率。2.建立人体右下肢有限元模型,验证模型的有效性。3.建立不同结构髓内针肿瘤膝关节假体模型,肿瘤膝关节置换术后人体右下肢有限元模型。4.通过有限元仿真,将股骨的应力遮挡情况、髓内针微动情况进行对比分析,得到最佳的髓内针模型。本发明的髓内针外部带有Gyroid多孔结构,适合骨长入,保证了髓内针与骨的融合性,多孔结构弹性模量与股骨接近,屈服强度高于皮质骨的屈服强度,满足髓内针的力学要求,能够有效减轻假体对股骨的应力遮挡效应,减小假体微动,提升初始稳定性。
Description
技术领域
本发明属于生物力学领域,具体涉及一种基于3D打印的肿瘤膝关节假体多孔髓内针及其设计方法。
背景技术
股骨原发肿瘤总体发病率虽不高,但常造成患者肢体残疾甚至危及生命。保肢手术主要包括受累骨瘤段的完整切除和骨缺损的重建。金属肿瘤型人工膝关节假体由于术后即刻稳定、术后短期及长期功能满意等优点,目前已成为保肢术后功能重建的首选。肿瘤型人工关节的无菌性松动是影响人工关节使用寿命和远期疗效常见的并发症,也是导致假体手术失败的常见原因之一。许多研究表明,无菌性松动是多因素相互作用的,无菌性松动的力学因素包括假体的初始稳定性和应力遮挡。其中,初始稳定性由骨-假体间的微动决定,小于40μm促进骨长入,大于150μm促进纤维组织形成,导致假体松动。同时,常见钛合金金属髓内针的弹性模量可达130GPa,与人体骨骼(3-20GPa)相差甚远,弹性模量不匹配会导致应力遮挡效应。
目前常用的假体髓内针固定方式有两种:骨水泥固定和生物固定两种。使用骨水泥固定的肿瘤型人工关节初始稳定性较好,但是会产生骨水泥颗粒,骨水泥破碎会产生磨屑,假体-骨水泥、骨-骨水泥界面的降解和剥离也会产生磨屑,这些碎屑通常导致假体周围感染和松动的发生。而生物固定的肿瘤型人工关节假体初始植入时,初始稳定性与骨水泥相比较差,易产生微动,而且髓内针与骨界面应力较大,周围应力遮挡相较骨水泥固定更为严重,易导致骨质溶解。现有的生物固定型假体大部分多孔表面喷涂的假体其骨长入范围及程度均有限,不仅与喷涂的孔隙率有关,更重要的是喷涂表面的厚度不够,随着制备技术的进步,空间结构不规则、连通性不好等问题也暴露出来。连通性保证了骨长入的深度和骨整合的牢固程度。
近年来,3D打印快速成型技术在骨科领域得到了普遍推广和应用,正在逐渐成为解决人工假体与骨界面整合的技术突破口。3D打印技术在骨科领域的最大进展应属人工金属假体的设计制造,其中最主要的突破莫过于人体负重骨缺损的金属假体快速成型。大量临床实践已经证实,3D打印多孔金属骨小梁结构可以很好地与髓腔内侧自体骨整合。镂空的多孔结构有利于再生骨组织长入假体内部,并在假体表面形成牢固的骨整合,这大大增加了假体的远期稳定性和使用寿命。
发明内容
(一)解决的技术问题
根据以上现有技术的不足,本发明要解决的技术问题是:提供一种基于3D打印的肿瘤膝关节假体多孔髓内针及其设计方法,设计的髓内针采用生物固定方式,能够在保证具有足有的屈服强度的前提下,尽可能使其与股骨接触部分弹性模量与骨组织匹配,减小应力遮挡效应,降低假体微动,提升初始稳定性,同时保证多孔结构的连通性,有利于骨长入,提高骨整合的牢固程度。
(二)技术方案
为达到上述目的,本发明提供如下技术方案:
一种基于3D打印的肿瘤膝关节假体多孔髓内针及其设计方法,包括以下步骤:
步骤1:本发明所述的假体多孔髓内针的顶端为实体,方便手术植入,杆分为内层和外层两部分,内层为致密钛合金,可以保证髓内针的强度,外层为Gyroid多孔结构,其内部互连互通,光滑连续,平均曲率为零,与人体骨小梁结构有相似之处,适宜骨长入,可以用来减轻应力遮挡效应,这种多孔结构的隐式曲面方程如下:
步骤2:通过软件读取人体股骨CT灰度值(GV),计算了股骨皮质骨密度(ρ)及弹性模量(E),计算公式如下:
ρ=-13.4+1017×GV
E=-388.8+5925ρ
构建了适合骨长入的50%、60%、70%三种孔隙率的Gyroid多孔结构模型,并进行准静态压缩实验,计算其力学性能,并与股骨皮质弹性模量进行对比,得到与股骨皮质骨弹性模量相匹配的Gyroid多孔结构模型。
步骤3:使用逆向建模的方法构建了人体右下肢非线性有限元模型,并通过分析股骨、胫骨应力分布,验证了模型的有效性,模型可用于后续的生物力学分析。
步骤4:构建了生物固定型膝关节假体有限元模型、包含多孔结构的髓内针的肿瘤膝关节假体有限元模型、肿瘤膝关节置换手术后人体右下肢有限元模型,
步骤5:模拟人体单腿站立及从椅子站起两种典型姿态,进行生物力学仿真,通过分析股骨、髓内针应力分布情况,计算应力遮挡率,对比假体微动情况,得到最适合的髓内针模型。
(三)有益效果
与现有技术相比,本发明提供了一种基于3D打印的肿瘤膝关节假体多孔髓内针及其设计方法,具有以下有益效果:本发明所述的髓内针分为内外两部分,内部为致密钛合金,可以保证假体强度;外部的多孔结构选取了连通性好,与人体股骨弹性模量相近的Gyroid多孔结构,此种设计可以提供适合骨生长的孔径和孔隙率,可以有效降低了髓内针对股骨的应力遮挡率,同时可以减小假体微动,提升初始稳定性。
附图说明
图1是本发明实施例髓内针结构示意图;
图2是本发明实施例多孔髓内针局部剖面示意图;
图3是本发明实施例所建立的Gyroid晶胞单元模型示意图;
图4是本发明实施例所打印的不同孔隙率的Gyroid多孔结构压缩实验试件实物图;
图5是本发明实施例所建立的人体右下肢有限元模型示意图;
图6是本发明实施例所建立的肿瘤膝关节置换术后人体右下肢有限元模型;
图7是本发明实施例所建立的股骨模型10个感兴趣区域示意图;
图8是本发明实施例股骨植入不同结构髓内针后应力遮挡情况对比示意图。
具体实施方式
下面将对本发明实施例中的附图,对发明实例中的技术方案进行具体说明,完整的描述,显然,所描述的实例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
本发明提供了一种基于3D打印的肿瘤膝关节假体多孔髓内针及其设计方法,包括以下步骤:
步骤1:如图1、图2所示,本发明所述的肿瘤膝关节假体多孔髓内针,髓内针直径为13mm,长度为140mm,髓内针分为内外两部分,其中外部多孔部分采用Gyroid多孔结构,这种多孔结构的隐式曲面方程如下:
其中Gyroid晶胞单元大小由“L”表示,“C”是用于调整Gyroid的偏置函数,通过求解上述方程,可以获得周期性节点表面。当偏置函数C为常数时,形成的Gyroid模型为均匀孔径模型;利用MSLattice软件可以建立具有目标单元尺寸和孔隙率的Gyroid模型,通过赋予不同的偏置函数,建立了多孔结构参数如表1孔径Gyroid模型。如图3所示,为孔隙率为50%的Gyroid晶胞单元模型。
表1多孔结构参数表征
利用3D打印技术,使用Ti6A14V材料打印上述参数的Gyroid多孔结构压缩试验样件,如图4所示,具体的打印工艺参数如表2所示。
表2 LiM-X150A主要打印参数
步骤2:通过Mimics20.0软件读取人体右下肢股骨CT灰度值,计算了股骨皮质骨的弹性模量,计算公式如下:
ρ=-13.4+1017×GV
E=-388.8+5925ρ
计算得到股骨皮质骨弹性模量最低为5.4GPa,对打印好的Gyroid多孔结构试件按国家标准GB/T31930-2015进行压缩实验。通过分析实验得到的应力应变曲线,可得到50%孔隙率多孔结构的弹性模量为4.95GPa,接近皮质骨的弹性模量,可以有效减小应力遮挡效应,屈服强度为241MPa,高于皮质骨的屈服强度,保证了多孔结构自身的可靠性。表3为Gyroid多孔结构力学性能。
表3 50%孔隙率Gyroid多孔结构的力学性能
步骤3:获取健康人体右下肢CT数据,采用Mimics20.0软件初步建立人体右下肢的三维模型,所有模型以STL格式保存并导入Geomagicstudio12进行进一步填充孔洞,光滑曲面等处理,以构建实体模型。接着,将三维曲面模型导入Hypermesh进行网格的划分,成功建立了如图5的人体右下肢有限元模型,通过模拟人体单腿站立以及从椅子上站起两种姿态,分析股骨与胫骨应力分布,验证了模型的有效性,可用于后续的生物力学分析。
步骤4:构建了生物固定型膝关节假体有限元模型,外层包含2mm厚Gyroid多孔结构的髓内针的肿瘤膝关节假体有限元模型,建立如图6所示的肿瘤膝关节置换术后手术有限元模型。
步骤5:模拟人体单腿站立及从椅子站起两种典型姿态,进行生物力学仿真,对髓内针对应的股骨部分划分“感兴趣区域(ROIs)”,如图7所示。通过分析股骨、髓内针在ROIs的应力分布情况,分析应力遮挡的改善情况,如图8所示,应力遮挡率计算公式如下:
σ0:置换手术前股骨等效应力,σ1:置换手术后股骨等效应力
经计算,常规生物柄应力遮挡率可达41%,而本发明的带有Gyroid多孔结构的髓内针应力遮挡率为17%,验证了本发明的髓内针可以有效降低应力屏蔽率,同时,本发明具有最小幅度的微动,初始稳定性更佳,更符合下肢生物力学。
综上所述,本发明在首先通过建模和实验选择了弹性模量与强度均适合植入人体的多孔结构,然后通过医学逆向建模方法,对人体下肢进行术前和术后建模,分析术后股骨的应力分布情况,计算应力屏蔽率,分析髓内针微动情况,得到符合下肢生物力学要求的髓内针结构。该发明提供了一种带有Gyroid多孔结构的髓内针,适用于肿瘤型膝关节假体置换术。该肿瘤型假体髓内针外部多孔结构连通性好,孔隙率与孔径均适合骨组织长入,同时能够有效减轻假体应力遮挡效应,降低微动,提升初始稳定性。
Claims (2)
1.本发明所述的肿瘤膝关节假体髓内针,髓内针顶部为致密实体,中段分为外和内两部分,内部为致密实体,外层为多孔结构,多孔结构采用的是Gyroid结构,多孔结构具体设计参数如表1所示:
表1多孔结构参数表征
2.本发明首先设计并3D打印了三种不同孔隙率的Gyroid结构模型,并进行准静态压缩试验,计算其弹性模量与屈服强度,并与计算的得到的股骨皮质骨弹性模量进行对比,得到弹性模量与皮质骨接近,屈服强度高于皮质骨的Gyroid多孔结构模型;采用逆向建模的方法建立了人体右下肢有限元模型,并建立了不同髓内针结构的肿瘤膝关节假体模型、肿瘤膝关节置换术后的人体右下肢骨骼有限元模型,并进行了有限元分析,通过分析术后股骨与髓内针的应力分布情况,髓内针微动情况,得到了能够有效减轻假体对股骨应力遮挡,同时提升初始稳定性的髓内针模型。
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