CN1668258A - 有两半的关节的植入物 - Google Patents

有两半的关节的植入物 Download PDF

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CN1668258A
CN1668258A CN02829606.0A CN02829606A CN1668258A CN 1668258 A CN1668258 A CN 1668258A CN 02829606 A CN02829606 A CN 02829606A CN 1668258 A CN1668258 A CN 1668258A
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articulated elements
implant
central axis
described implant
sliding surface
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CN100427045C (zh
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D·鲍姆加特纳
A·布里
C·马蒂厄
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AO Technology AG
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MARS MEDICAL TECHNOLOGY AG
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Abstract

本发明涉及植入物，尤其是椎间植入物，包括A)两个铰接件(4；5)，它们各有一中心轴线(1；26)、各一个弯曲的与中心轴线(1；26)相交的滑动面(6；7)以及各一个沿轴向在外部可与骨连接的端部(14；15)，其中B)滑动面(6；7)设计为弯曲的和可相对滑移，其中D)第二铰接件(5)可绕两条歪斜地排列的旋转轴线(10；11)相对于第一铰接件(4)旋转。

Description

有两半的关节的植入物
本发明涉及一种按权利要求1前序部分所述的植入物，尤其是椎间植入物。
在人体的各个关节中，例如外侧股骨髁与髋骨之间的关节或掌骨与远侧指骨之间的关节，存在一些骨关节面，其中一个优选的骨关节允许绕一条或多条关节轴线以及另一侧的一个骨关节允许有限地或根本不允许绕其他所有在空间可能的旋转轴线。包括一个有多条旋转轴线的关节的植入物还用作椎间植入物，确切地说椎间盘内假体。
一个或多个损坏的天然椎间盘或椎间盘的一个损坏的核通常被去除和部分用植入物或假体代替，它们置入两个相邻椎体之间的椎间腔内。这样做的目的是重新恢复尽可能天然的状态，也就是说，尤其重新构建原始的椎间盘高度并因而两个相邻椎体之间原始的距离。椎体的运动应不受植入物或假体影响地也能继续在其自然范围内实施。为此在自然的界限内向前/向后倾斜，亦即脊柱弯曲或伸展时以及椎体侧向弯曲时获得运动的可能性是至关重要的。同样应允许在生理学的运动范围内相邻椎体彼此改变在空间的相对位置。
由US6,368,350 ERICKSON已知一种作为椎间盘的代用品可植入的器械。这种已知的器械主要包括两个带端板的关节部分。由一个凸的和一个互补的凹的关节部分组成的关节按一种实施形式有球状的关节面，所以关节部分可绕不同的处于一个平面内的旋转轴线转动，以及对于椎体的侧弯没有限于一条旋转轴线和对于椎体的弯曲/伸展没有限于另一条旋转轴线。此外相邻的椎体可以没有限制地绕其纵轴线转动。按另一种实施形式，关节面是椭圆体表面，所以旋转轴线同样对于椎体的侧弯不限于一条旋转轴线，以及对于椎体的弯曲/伸展不限于另一条旋转轴线。
本发明将提供补救办法。本发明的目的是创造一种有两个万向铰接件的植入物，它有两条旋转轴线，它们彼此歪斜和在空间有确定的距离，所以相邻椎体的运动在切除在它们之间的椎间盘后可通过植入物恢复。
按本发明为达到此目的通过一种有权利要求1特征的植入物，优选椎间植入物达到。
按本发明的植入物主要包括两个有彼此铰接的滑动面的铰接件，在铰接件彼此相对转动时滑动面相互滑移。每个铰接件有一条基本上平行或同轴于两个相邻骨的纵轴线延伸的中心轴线，它们在体位挺直时的静止位置，亦即在铰接件彼此不倾转时重合。此外，铰接件各包括一个沿轴向在外部可与骨连接的端部。在植入物设计为椎间植入物时，这些端部可与相邻的椎体连接，而中心轴线基本上与脊柱纵轴线平行或同轴地延伸。滑动面与铰接件的中心轴线相交以及在铰接件彼此相对转动时相互滑移，在这种情况下第二铰接件可绕两条歪斜地排列的旋转轴线相对于第一铰接件旋转。
下面假定第一个铰接件固定和第二个铰接件可以运动。因此旋转轴线相对于第二铰接件固定而相对于第一铰接件可以运动。
采用本发明获得的优点主要在于，由于按本发明的植入物，尤其椎间植入物。
-在椎体弯曲或伸展时和/或侧弯时旋转中心的位置更好地符合生理学；
-滑动面可以在没有大的摩擦力的情况下彼此滑移，以及通过恢复相应的力偶臂使力和力矩尽可能小；以及
-可以达到增强椎体绕脊柱纵轴线扭转运动的刚性。
按本发明的植入物优选的实施形式，滑动面设计为鞍形以及各有一个鞍点。鞍形的滑动面设计为，在一个面积点(Flchenpunkt)P的每个以铰接件尺寸为界的范围内始终可提供两个面积点，它们处于通过面积点P的切面不同侧上。
按本发明植入物另一种实施形式，旋转轴线以一个角度相交，此角度优选地在80°与100°之间。由此可获得的优点是，例如一个椎间植入物可如此植入，即，使旋转轴线之一平行或同轴于椎体侧弯的轴线定向以及第二条旋转轴线平行或同轴于椎体弯曲或伸展的轴线定向。
按本发明的植入物另一种实施形式，旋转轴线彼此有一个最小距离A，它在0.1mm与20mm之间，优选地在2mm与20mm之间。距离A还通过按本发明的植入物在脊柱上的使用地点共同确定，以及根据在腰脊柱内的节段高度改变和朝胸椎体的方向减小。
优选地，滑动面设计为，当第二铰接件绕每一条旋转轴线旋转时，第二鞍点在与旋转轴线同心的圆弧上移动。滑动面设计为鞍形的优点是，也允许铰接件绕铰接件的中心轴线转动。但是当铰接件沿轴向彼此相对转动时，这两个铰接件沿轴向彼此离开，所以轴向转动只能在同时改变植入物高度时实施。通过在脊柱内韧带、肌肉和肌腱恒定的预紧力，铰接件的轴向转动只能有限地进行。这类似地也适用于在腰脊柱内的生理状况，在那里由于后部元件，如小面关节(Facettengelenke)，也只有限地允许轴向转动。
优选地，滑动面在铰接件的静止状态观察设计为完全一致的。通过按本发明的植入物设计为有完全一致的滑动面，可以达到椎体绕脊柱纵轴线的扭转运动不可能不改变椎间植入物的高度。通过在这种运动时改变椎间植入物的高度使韧带拉紧，由此施加一个抗椎体扭转的阻力。
按本发明植入物的另一种实施形式，铰接件的外端各围着一个连接部分，它可与相邻的骨或椎体连接。在将按本发明的植入物用作椎间植入物时，这些连接部分优选地设计为盖板，它们各有一个沿轴向在外面的横向于中心轴线设置的表面，在这里，这些表面可设计有一种三维的结构，例如构造有毛边。
在这里，盖板之一也可与相邻的铰接件是一体的。
按本发明的植入物作为椎间植入物的一种实施形式，盖板之一包括一个垂直于相邻铰接件中心轴线延伸的导引装置或槽，相邻的铰接件设计为与此导引装置互补的后端可插入导引装置内。由此可获得的优点是，首先两块盖板可与第一铰接件并列地在相邻椎体之间移动，接着盖板可压在相邻椎体的端面上，以及，最后才将第二铰接件插入第一铰接件与第二盖板之间，从而在植入期间椎体只须最小程度地拉开。插入的第二个铰接件在插入后固定在盖板上。
铰接件可按应用设计为金属/金属对。此外采用陶瓷材料也是恰当的，因为由于脊柱内相邻椎体之间大的预紧力，所以铰接件受冲击作用的负载小。
按本发明植入物的另一种实施形式，铰接件之一用塑料制造，所以
-可以使用已提及的关节代用材料的组合，例如高度交联的聚乙烯(UHMWPE)和钴-铬合金；
-可达到在滑动面彼此相对移动时小的摩擦力；以及
-可为铰接件绕中心轴线转动时提供阻尼。
按本发明的植入物再一种实施形式，铰接件之一可绕其中心轴线旋转地可安装在配属的连接部分上，确切地说可安装在配属的盖板上。为此，例如铰接件的外端装在配属的连接部分或配属的盖板上一个互补的与中心轴线同轴的槽内。按另一种方式，连接部分可设有与中心轴线同轴的隆凸以及铰接件设有互补的凹槽。由此可获得的优点是，两个相邻椎体的扭转运动不因植入物而受阻。
按本发明的植入物另一种实施形式，铰接件之一可以平行于一条与中心轴线垂直地延伸的移动轴线移动地安装在配属的连接部分上，确切地说配属的盖板上。优选地，铰接件的外端在终端设有一个与中心轴线同轴的扩展段，而配属的连接部分或配属的盖板包括一个与铰接件的外端互补的具有一个用于容纳扩展段的掏槽的槽。采用按本发明的植入物的这种设计，也允许在两个与植入物相邻的椎体之间实施单轴的剪切运动，不会因有此植入物而阻碍此剪切运动。通过设计槽的长度可以将椎体的剪切运动限制在期望的范围内。
按本发明的植入物再另一种实施形式，铰接件之一可以在一个垂直于中心轴线的平面内移动地安装在配属的连接部分或配属的盖板上。为此优选地铰接件的外端的直径小于在配属的连接部分上的槽的直径。由此可获得的优点是，也可以允许与植入物相邻的椎体相对于多条轴线作剪切运动。
在从属权利要求中说明本发明另一些有利的设计的特征。
下面借助局部示意表示的多个实施例更详细地说明本发明和本发明的进一步发展。
其中：
图1a按本发明的植入物一种实施形式的视图，其中第二铰接件已绕第一旋转轴线转动；
图1b按本发明的植入物如图1a所示实施形式的侧视图；
图1c按本发明的植入物如图1a和1b所示实施形式的视图，其中第二铰接件绕第二旋转轴线转动；
图1d按本发明的植入物如图1c所示实施形式的侧视图；
图2按本发明的植入物一种实施形式第一铰接件透视图；
图3按本发明的植入物作为椎间植入物的一种实施形式透视图；
图4a按本发明的植入物一种实施形式从腹部看的视图；
图4b按本发明的植入物如图4a所示实施形式从侧面看的视图；
图5按本发明的植入物另一种实施形式的视图，包括可相对于中心轴线旋转地装在盖板上的铰接件；
图6a按本发明的植入物另一种实施形式的视图，包括可在一个垂直于中心轴线的平面内移动地安装的铰接件；
图6b按本发明的植入物如图6a所示实施形式的剖面图；
图7a按本发明的植入物另一种实施形式视图，包括可垂直于中心轴线移动地安装的铰接件；以及
图7b通过如图7a所示按本发明的植入物实施形式的剖面图。
图1a至1d表示按本发明的植入物的一种实施形式，包括第一和第二铰接件4，5，其中图1b表示两个铰接件4；5的侧视图A。第一铰接件4有第一中心轴线1和与此第一中心轴线1相交的第一滑动面6。第一滑动面6设计为鞍形以及有第一鞍点8。与第一铰接件4类似，第二铰接件5有第二中心轴线2b以及与此第二中心轴线2b相交的第二滑动面7。第二滑动面7也设计为鞍形和有鞍点9。此外，铰接件4；5包括在外面的端部14；15，它们可被置于与和铰接件相邻的骨尤其相邻的椎体的端面接触。在一个与中心轴线1正交的平面内观察，旋转轴线10；11在此平面内的投影成90°角相交。按滑动面6；7的这种设计，最小距离A是在这两条旋转轴线10；11上的垂线。在图1a和1b中，第二铰接件5已绕第一旋转轴线10(图1b)旋转。第二鞍点9在第二铰接件5转动角度β时在一个与第一旋转轴线10同心的半径为R1的圆弧上移动。
图1c和1d表示按本发明的植入物如图1a和1b所示实施形式的铰接件4；5，其中第二铰接件5绕第二旋转轴线11(图1c)转动了角度α。在第二铰接件5绕第二旋转轴线11作此转动时，第二鞍点9在一个与第二旋转轴线11同心的半径为R2的圆弧上移动。
图2表示第一铰接件4，它有一个设计为鞍形的第一滑动面6。图中，表示两条旋转轴线10；11当体位相应地直立时，换句话说，第一铰接件4的中心轴线与第二铰接件5的中心轴线(图1)重合时，处于按本发明的植入物的静止位置。在静止位置，旋转轴线10；11垂直于中心轴线1并处于平面22；23内。第一旋转轴线10垂直于第一平面22，第一平面22通过中心轴线1和第二旋转轴线11展开。第二旋转轴线11垂直于与第一平面22垂直的第二平面23，它通过中心轴线1和第一旋转轴线10展开。第一滑动面6的第一鞍点8在静止位置时既处于中心轴线1上又处于两个圆弧24；25上，圆弧的中心在铰接件4；5的静止位置由中心轴线1与每一条旋转轴线10；11的交点确定。第一滑动面6一方面偎依与第一旋转轴线10同心的第一圆弧24以及另一方面也偎依与第一旋转轴线11同心的圆弧25。第一圆弧24的半径R1与第二圆弧25的半径R2在滑动面6；7完全一致时大小相等并相当于两条旋转轴线10；11距离A的一半。
滑动面6设计为，使它具有部分花托状表面的互补形状。
图3表示按本发明的植入物作为椎间植入物的实施形式。两个铰接件4；5包括在其外端14；15的各一块盖板12；13作为连接部分2；3，它们有相对于中心轴线1；26沿轴向在外面的并横向于中心轴线1；26延伸的表面16；17，它们可被置于与相邻椎体的端面接触。盖板12；13各有两个横向的侧面27、一个前侧面28和一个后侧面29，其中，横侧面27基本上平行于第一旋转轴线10布置。前和后侧面28；29基本上平行于第二旋转轴线11布置。植入物以这样的方式插入相邻的椎体(图中未表示)之间，即，使得铰接件4；5绕第一旋转轴线10的转动允许与植入物相连接的椎体侧弯，而铰接件4；5绕第二旋转轴线11的转动允许与植入物连接的椎体弯曲或伸展。在这里表示的按本发明的植入物实施形式中，第一盖板12与第一铰接件4固定连接，而第二盖板13有一个垂直于中心轴线26并基本上平行于横侧面27布置的设计为槽的导引装置20，所以第二铰接件5可将其在外面的设计为与导引装置20互补的端部15插入导引装置20内。此外，在盖板12；13的外部表面16；17上还加上毛边19，它们用于植入物在相邻椎体上初始的稳定。
在图4a和4b中表示的按本发明的植入物实施形式与按本发明的植入物如图3所示实施形式的差别仅在于，它们没有毛边19，以及，铰接件4；5只能在有限的转角α和β范围内绕旋转轴线10；11转动。图4a表示从腹部，亦即平行于旋转轴线10观察植入物，而在图4b中表示从侧向，亦即平行于旋转轴线11观察植入物(图4b)。角度α和β的范围通过选择在铰接件4；5上的尺寸HL；HA；HP；R1；R2；h1和h2确定，在这里，当达到期望的最大转角α或β时，铰接件4；5总是朝另一个铰接件4；5定向的铰接件4；5端部32；33；34位于与各自铰接件4；5相对置的盖板12；13的内表面30；31上，以及
HL：第一鞍点8与第一铰接件4朝第二铰接件5方向的内端32之间的高度；
HA：第二鞍点9与第二铰接件5朝第一铰接件4方向的前端34之间的高度；
HP：第二鞍点9与第二铰接件5朝第一铰接件4方向的后端33之间的高度；
R1：第一滑动面6在垂直于第一旋转轴线10并含有第一鞍点8的第一平面22(图2)内的半径；
R2：第二滑动面在垂直于第二旋转轴线11并含有第二鞍点9的第二平面23(图2)内的半径；
h1：第一鞍点8与第一盖板12内表面之间的高度；以及
h2：第二鞍点9与第二盖板13内表面之间的高度。
图5表示按本发明的植入物实施形式，它与图1至4所示实施形式的差别在于，第一铰接件4的外端14装入盖板12内一个与中心轴线1同心的互补槽37内，所以第一铰接件4可绕中心轴线1旋转地与盖板12组合。
图6a和6b表示按本发明的植入物一种实施形式，它与图5所示实施形式的差别仅在于，与中心轴线1同心的槽37有比第一铰接件4的外端14大的直径，所以第一铰接件4可在一个垂直于中心轴线1的平面内相对于盖板12移动。
图7a和7b表示按本发明的植入物一种实施形式，它与图5所示实施形式的差别仅在于，槽37平行于一条垂直于中心轴线1延伸的移动轴线40设计为椭圆形并有一掏槽39，而第一铰接件4的外端14在终端包括一个与中心轴线1同轴的扩展段38，扩展段38插入掏槽39内，所以第一铰接件4一方面可以平行于移动轴线40移动，以及另一方面通过插入掏槽39内的扩展段38相对于中心轴线1沿轴向固定。

Claims (18)

1.植入物，尤其是椎间植入物，包括
A)两个铰接件(4；5)，它们各有一中心轴线(1；26)、各一个与中心轴线(1；26)相交的滑动面(6；7)以及各一个沿轴向在外部可与骨连接的端部(14；15)，其中
B)滑动面(6；7)设计为弯曲的，
其特征为：
C)滑动面可彼此滑移；以及
D)第二铰接件(5)可绕两条歪斜地排列的旋转轴线(10；11)相对于第一铰接件(4)旋转。
2.按照权利要求1所述的植入物，其特征为：滑动面(6；7)设计为鞍形。
3.按照权利要求1或2所述的植入物，其特征为：旋转轴线(10；11)以一个在80°与100°之间的角度相交。
4.按照权利要求1至3之一所述的植入物，其特征为：旋转轴线(10；11)彼此有一个最小距离A；以及，距离A在0.1mm与20mm之间。
5.按照权利要求4所述的植入物，其特征为：距离A在2mm与20mm之间。
6.按照权利要求1至5之一所述的植入物，其特征为：滑动面(6；7)各有一个鞍点(8；9)，当第二铰接件(5)绕每一条旋转轴线(10；11)旋转时，第二鞍点(9)在一个与各自的旋转轴线(10；11)同心的圆弧(12；14)上移动。
7.按照权利要求1至6之一所述的植入物，其特征为：滑动面(6；7)在铰接件(4；5)中心轴线(1；26)同轴时的原始位置设计为完全一致的。
8.按照权利要求1至7之一所述的植入物，其特征为：铰接件(4；5)的外端(14；15)各围着一个连接部分(2；3)。
9.按照权利要求8所述的植入物，其特征为：连接部分(2；3)设计为盖板(12；13)，它们各有一个沿轴向在外面的横向于中心轴线(1；26)设置的表面(16；17)。
10.按照权利要求9所述的植入物，其特征为：盖板(12；13)之一与相邻的铰接件(5)是一体的。
11.按照权利要求9或10所述的植入物，其特征为：盖板之一(12)包括一个垂直于中心轴线(1)延伸的导引装置(20)；以及，相邻的铰接件(4)有一个可插入导引装置(20)中的后端(14)。
12.按照权利要求8至11之一所述的植入物，其特征为：铰接件(4；5)之一可绕其中心轴线(1；26)旋转地可与配属的连接部分(2；3)接合。
13.按照权利要求8至12之一所述的植入物，其特征为：铰接件(4；5)之一可在一条与其中心轴线(1；26)垂直的移动轴线(40)上移动地与配属的连接部分(2；3)接合。
14.按照权利要求8至13之一所述的植入物，其特征为：铰接件(4；5)之一可在一个与其中心轴线(1；26)垂直的平面内移动地与配属的连接部分(2；3)接合。
15.按照权利要求12至14之一所述的植入物，其特征为：一个连接部分(2；3)有一个与中心轴线(1；26)同轴的槽(37)，用于承接相邻铰接件(4；5)的外端(14；15)。
16.按照权利要求15所述的植入物，其特征为：槽(37)沿轴向的终端有一掏槽(39)；以及，相邻铰接件(4；5)的外端(14；15)有一个与中心轴线(1；26)同轴的可装入掏槽(39)内的扩展段(38)。
17.按照权利要求1至16之一所述的植入物，其特征为：铰接件(4；5)之一用塑料制造。
18.按照权利要求1至17之一所述的植入物，其特征为：至少铰接件(4；5)之一用陶瓷材料制造。
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AU (1) AU2002322984B2 (zh)
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EP1539051B1 (de) 2008-05-07
US8092540B2 (en) 2012-01-10
CN100427045C (zh) 2008-10-22
ES2306774T3 (es) 2008-11-16
ATE394083T1 (de) 2008-05-15
AU2002322984A1 (en) 2004-04-08
US7537614B2 (en) 2009-05-26
WO2004026186A1 (de) 2004-04-01
US20050256577A1 (en) 2005-11-17
JP4210648B2 (ja) 2009-01-21
US20090204217A1 (en) 2009-08-13
JP2005538783A (ja) 2005-12-22
EP1539051A1 (de) 2005-06-15
DE50212245D1 (de) 2008-06-19
CA2497623A1 (en) 2004-04-01
AU2002322984B2 (en) 2006-06-22
CA2497623C (en) 2011-05-17

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