CN101416907B - 人工股骨柄及其人工全髋关节置换假体 - Google Patents

人工股骨柄及其人工全髋关节置换假体 Download PDF

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CN101416907B
CN101416907B CN200810239001A CN200810239001A CN101416907B CN 101416907 B CN101416907 B CN 101416907B CN 200810239001 A CN200810239001 A CN 200810239001A CN 200810239001 A CN200810239001 A CN 200810239001A CN 101416907 B CN101416907 B CN 101416907B
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王岩
郑诚功
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Beijing Naton Technology Group Co Ltd
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Abstract

本发明提供一种人工股骨柄，包括颈部段和锚定部段，其特征在于：所述锚定部段的内侧曲线为AVN患者对应部位的解剖曲线，还提供一种包含该股骨柄的人工全髋关节置换假体。本发明的股骨柄与患者股骨髓腔的型合度高，可以提高置换假体的远期稳定性。

Description

人工股骨柄及其人工全髋关节置换假体
技术领域
本发明涉及人工移植技术，特别是涉及一种针对股骨头缺血性坏死的特异性人工股骨柄及采用该柄的人工全髋关节置换假体。
背景技术
股骨头缺血性坏死(Avascular Necrosis简称AVN)是临床常见疾病，其病因在于患者由于各种病因，破坏了股骨头的血供导致股骨头缺血、坏死、塌陷，常导致严重髋关节功能障碍，是目前常见而又难治的疾病之一。
人工全髋关节假体置换是AVN晚期患者的一种主要的治疗手段。
为解决人工全髋关节假体置换技术中水泥型假体远期松动率逐年增高的问题，从上世纪七十年代开始在股骨柄侧应用非骨水泥固定技术，而在髋臼侧的应用是从八十年代开始的，为获得假体的稳定曾经有过许多不同的设计，但只有部分假体获得了成功，经过深入研究，人们逐渐发现只有在假体和骨之间达到相当的密合度，微动小于28μm到50μm时才能获得可靠的骨长入，因而假体的几何形状决定了这种密合程度，也决定了假体的远期存活率。然而，过去已有的表面沟槽、各种组配式设计，以及近年来的解剖型设计均是通过正常西方人的测量数据经过统计学处理后得到的平均数值设计的，而且这些根据西方人骨骼数据设计的假体很难和国人的骨骼特征获得较好的匹配，至于为此采取的表面涂层改进，各种螺钉、棘突等辅助固定设计也仅仅是提供了假体早期稳定，而实现假体远期稳定的必由之路就是增加假体和骨的型合度。
目前认为钛合金材料仍是最佳的内固定物材料，因为这种材质具有良好的生物相容性和与皮质骨相仿的弹性模量，因而异物反应小，理论上也会带来较少的应力遮挡，但是这并不意味着假体与骨的型合度不再重要，相反这为股骨近端的固定提出了更高的要求，因为股骨髓腔近端存在大量的松质骨，其与钛合金内植物的弹性模量相差很多，而现有假体设计都没有将假体股骨近端与髓腔皮质骨的型合度提到合适的高度来审视。临床上有经验的医生总是通过过多的去除松质骨去适应假体的形状来实现可接受的型合度匹配，这无异于“削足适履”。
影响骨与假体型合度的因素包括年龄、种族、性别等因素，而疾病种类是否为影响髓腔形状的因素尚未定论，但从最新的研究发现越来越多的文献支持股骨颈骨折与股骨形状具有相关性。
我国股骨头缺血性坏死导致的关节置换几乎占所有关节置换的40％，施行人工髋关节置换手术的AVN患者年龄仅大于先天性髋关节病人组，而比骨关节炎和股骨颈骨折患者的年龄小很多，故假体的存活时间，即实现假体远期稳定尤为重要。
临床中，通过186例AVN患者和213例正常人髋关节影像学数据，分析股骨侧髓腔差异、股骨前倾角差异及髋臼特征差异，发现我国AVN患者的髓腔前侧和内外侧曲线和常人存在统计学差异，以倒香槟型为主，这与术中所见相符。因此，根据AVN患者的骨骼特征来制作与其骨骼特征相匹配的置换假体具有重要的意义。
发明内容
本发明为了解决现有人工髋关节置换假体不能很好地与股骨进行型合、难以保证假体远期稳定的技术问题，本发明提供一种按照AVN患者股骨特征统计数据而设计的人工股骨柄置换假体，保证其与AVN患者的股骨特征具有较好的匹配特性，以获得良好的远期稳定。
本发明的另一个目的在于提供一种应用该人工股骨柄的人工全髋关节置换假体。
本发明的技术方案如下：
一种人工股骨柄，包括颈部段和锚定部段，其特征在于：所述锚定部段的内侧曲线为AVN患者对应部位的解剖曲线。
所述锚定部段的内侧曲线的方程式为y＝±A1x3+A3x2±A3x+A4；其中A1、A2、A3、A4均为系数，A1取值范围为-0.17000～0.04054，A2取值范围为-2.00586～7.10783，A3取值范围为-87.75095～40.25685，A4取值范围为-246.58554～338.85144。
所述内侧曲线部分长度为锚定部段总长度的10％～100％。
所述锚定部段的前侧曲线为AVN患者对应部位的解剖曲线。
所述锚定部段的前侧曲线的方程式为y＝±B1x3+B3x2±B3x+B4；其中B1、B2、B3、B4均为系数，B1取值范围为-0.17000～2.61338，B2取值范围为-75.67478～8.53086，B3取值范围为-73.68055～720.37993，B4取值范围为-3125.92948～283.55694。
所述前侧曲线部分为锚定部段总长度的10％～100％。
所述锚定部段为短柄结构。
所述锚定部段的远端高抛光。
所述锚定部段远端高抛光之外的部分具有广泛的涂层。
一种人工全髋关节置换假体，包括所述的人工股骨柄，其特征在于：还包括与所述人工股骨柄匹配使用的髋臼假体。
本发明的技术效果在于：
本发明人工股骨柄的锚定部段的曲线是按照AVN患者的股骨骨骼结构特征统计数据所得到的AVN患者的股骨髓腔内侧曲线而设计的，依照该曲线加工的人工股骨柄假体，使得股骨柄假体的内侧曲线和外侧曲线与AVN患者的股骨髓腔具有更高的型合度，从而实现人工假体与患者股骨髓内腔壁的硬质骨完美贴合，以提高假体的远期稳定性。从而解决一直以来所存在的假体与股骨髓腔的型合度差、远期稳定性差的问题。
本发明的人工股骨柄远端具有高抛光的表面，更为易于取出，且可减少远端固定的应力遮挡，且锚定部段的其余部位具有广泛的涂层，为远期骨长入提供生物固定。
附图说明
图1所示为本发明的人工全髋关节置换假体的结构示意图；
图2所示为本发明的人工股骨柄的轮廓示意图；
图3所示为图2所示的人工股骨柄的侧面视图；
具体实施方式
以下结合附图对本发明的人工全髋关节置换假体做进一步说明。
图1所示为本发明的人工全髋关节置换假体的结构示意图，包括相匹配的人工股骨柄1和髋臼杯4，人工股骨柄1包括颈部段2和锚定部段3，髋臼杯4可套装在颈部段2上，其中人工股骨柄1的锚定部段3与AVN患者对应部位的解剖曲线相一致。
本实施例中人工股骨柄1的锚定部段3采用短柄设计，以保留更多的骨量，且与AVN患者对应部位的解剖曲线相一致。
图2所示为人工股骨柄1的轮廓示意图，图3为其侧向视图。
其中曲线11为股骨柄的内侧曲线，曲线12为股骨柄的前侧曲线，其参数的设计采用统计学方法，经过对AVN患者的股骨骨骼结构特征测量统计处理而得，本实施例中，采用A-A、B-B、C-C、D-D、E-E、F-F、G-G、H-H等均分的各截面，经数理统计，测绘出AVN患者与正常人的股骨骨骼结构特征相区别的曲线。
本发明通过对大量的AVN患者的股骨骨骼结构的临床统计，经数理统计，测绘出内侧曲线11的方程式为y＝±A1x3+A3x2±A3x+A4；其中A1、A2、A3、A4均为系数，A1取值范围为-0.17000～0.04054，A2取值范围为-2.00586～7.10783，A3取值范围为-87.75095～40.25685，A4取值范围为-246.58554～338.85144。
内侧曲线11部分的长度占锚定部段3总长度的10％～100％。
图3中，前侧曲线12的方程式为y＝±B1x3+B3x2±B3x+B4；其中B1、B2、B3、B4均为系数，B1取值范围为-0.17000～2.61338，B2取值范围为-75.67478～8.53086，B3取值范围为-73.68055～720.37993，B4取值范围为-3125.92948～283.55694。
前侧曲线12部分的长度占锚定部段3总长度的10％～100％。
同理，参照同样的设计方法，可以测绘出与所述曲线11、12位于相垂直方向的股骨外侧和后侧曲线，以及股骨柄前倾角度和股骨柄颈部的倾角，这部分数据与常人的数据差异较小，将上述数据汇总，即可以建立与AVN患者的股骨骨骼结构特征更为接近的数学统计模型，并依照这种完全按照AVN患者的股骨骨骼结构特征建立的数学模型，加工制造出符合AVN患者的股骨骨骼结构特征的人工全髋关节置换假体，这种置换假体与过去完全依照西方正常人的股骨骨骼结构特征统计数据所制备的置换假体相比较，更为符合AVN患者的股骨几何外形，与患者股骨髓内腔壁的硬质骨具备更高的型合度，可以提高置换假体的远期稳定性。从而解决了假体与股骨髓腔的型合度差、远期稳定性差的问题。

Claims (3)

1.一种人工股骨柄，包括颈部段和锚定部段，其特征在于：所述锚定部段的内侧曲线为股骨头缺血性坏死患者股骨近端对应部位的解剖曲线，所述锚定部段的内侧曲线的方程式为y＝±A1x3+A2x2±A3x+A4；其中A1、A2、A3、A4均为系数，A1取值为-0.17000，A2取值为-2.00586，A3取值为-87.75095，A4取值为-246.58554；
所述内侧曲线部分长度为锚定部段总长度的10％～100％；
所述锚定部段的前侧曲线为股骨头缺血性坏死患者股骨近端对应部位的解剖曲线，所述锚定部段的前侧曲线的方程式为y＝±B1x3+B2x2±B3x+B4；其中B1、B2、B3、B4均为系数，B1取值为-0.17000，B2取值为-75.67478，B3取值为-73.68055，B4取值为-3125.92948；
所述前侧曲线部分长度为锚定部段总长度的10％～100％；
所述锚定部段的远端高抛光，所述锚定部段远端高抛光之外的部分具有广泛的涂层；
所述锚定部段的所述内侧曲线和前侧曲线是按照股骨头缺血性坏死患者的股骨骨骼结构特征统计数据所得到的股骨头缺血性坏死患者的股骨髓腔内侧曲线而设计的，依照所述内侧曲线和前侧曲线加工的人工股骨柄，使得所述人工股骨柄的内侧曲线和外侧曲线与股骨头缺血性坏死患者的股骨髓腔具有更高的型合度。
2.根据权利要求1所述的人工股骨柄，其特征在于：所述锚定部段为短柄结构。
3.采用权利要求1或2所述的人工股骨柄的人工全髋关节置换假体，包括所述的人工股骨柄，其特征在于：还包括与所述人工股骨柄匹配使用的髋臼假体。
CN200810239001A 2008-12-04 2008-12-04 人工股骨柄及其人工全髋关节置换假体 Expired - Fee Related CN101416907B (zh)

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