CN1774218A - 椎间植入物 - Google Patents

椎间植入物 Download PDF

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CN1774218A
CN1774218A CNA038263130A CN03826313A CN1774218A CN 1774218 A CN1774218 A CN 1774218A CN A038263130 A CNA038263130 A CN A038263130A CN 03826313 A CN03826313 A CN 03826313A CN 1774218 A CN1774218 A CN 1774218A
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intervertebral implant
fiber system
described intervertebral
fiber
core
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CN100484499C (zh
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D·鲍姆加特纳
M·怀曼
M·加戈霍
A·布里
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AO Technology AG
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Synthes AG Chur
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Abstract

本发明涉及一种具有一条中心轴线(2)的椎间植入物(1)，包括一个下盖板(3)和一个上盖板(4)，它们各具有一个横向于中心轴线(2)延伸的外表面(7、8)，并且包括一个在盖板(3、4)之间设置的中心部分(10)，该中心部分具有一个包括一个纤维系统(5)的外壳(12)，其中，纤维系统(5)与盖板(3、4)相连结并且置入到一个由均质材料构成的外壳体(25)中。该椎间植入物(1)可以类似于天然椎间盘的解剖学上的结构将在其盖板(3、4)上产生的压缩力作为拉力传到其纤维系统(5)的各个纤维上。

Description

椎间植入物
技术领域
本发明涉及按照权利要求1的前序部分所述的椎间植入物。
背景技术
一种此类的椎间盘假体由LEE氏的US 4,911,718是已知的。该已知的椎间盘假体包括一个中心的芯部，其由一生物相容的弹性体成形成使其大致相当于一个天然的椎间盘的髓核，并且包括一个围绕芯部设置的由结合于弹性体中的纤维构成的多层的叠片。每一叠片层具有自身的纤维系统，从而存在许多纤维组。各层具有不同的纤维取向，其中纤维相对于中心轴线的角度处在±20°至±50°之间的范围内，优选在0°、+45°与-45°之间。
由KLAUE氏的WO 90/00374还已知一种髋内假体(Hüftendoprothese)，其干由一种管形网构成，亦即一由至少两排相互交叉的纤维构成的组织。管形网的内部在作为股骨干部件的应用中保持是空的。
在LEE氏的US 4,911,718中公开的假体中，各个纤维虽然结合于叠片中，其由弹性体或其他类的塑料构成，但在其各端只粘结在端板上，从而其并未围绕芯部并从而在芯部径向伸展时其可以不承受拉力。在从基体-纤维复合物中剪取的侧壁粘结在端板上时结合的纤维本身在端板上的固定是相当困难的，只有纤维的横截面为化学结合提供一接触面。因此特别在各纤维在端板上的这些连结点上产生提高的应力值。
此外，各个纤维在LEE氏那里只具有从下盖板至上盖板的长度，这相当于外壳高度或一投影的外壳面积的对角长度。因此产生的力只可以沿这些长度由于纤维的剪切力传递被在弹性体上分解。由此在各固定点，亦即在各纤维末端上引起局部提高的应力。
在KLAUE氏的WO 90/00374中公开的假体包括一个纤维系统，其各个纤维并不在两端固定，并且没有可变形的芯部。因此在假体轴向压缩时产生的轴向压力可以不以拉力传到纤维上。
由STUBSTAD等人的US-A 3,867,728已知同一种椎间盘假体，其具有包括纤维系统的弹性的多层结构。在该已知的假体中不利的是，与各盖板连结的纤维系统或是不置入一个外壳体中或是在另一实施例中置入一个由弹性体构成的多层叠片中。
发明内容
在这里本发明将消除弊端。本发明的目的在于，提供一种椎间植入物，其包括连结于各盖板的纤维系统，借此加强一围绕中心部分的均质的材料构成的外壳体。
本发明利用具有权利要求1的特征的椎间植入物达到提出的目的。
通过本发明达到的优点可看出基本上在于，由于按照本发明的椎间植入物达到：
-纤维系统首先可以围绕中心部分包卷并紧接着可以注入到一个构成弹性的外壳体的弹性体中，从而可容易地制造围绕中心部分的外壳；
-通过弹性的材料围绕纤维系统的设置在其包卷以后按不同的方式、例如也在相互定向的各盖板的内表面锚定纤维系统是可能的；
-中心部分允许两邻接的椎骨体在压缩、屈曲或伸展、侧向弯曲和扭转的情况下运动；
-瞬时的转动中心或瞬时的转动轴线并不由椎间植入物预定，并且其可以按最小发生的力或力矩出现；
-通过沿圆周方向纤维数量、纤维横截面和材料选择的改变可以调节椎间植入物的特性，而使运动根据不同的发生的载荷处于与在天然的椎间盘中同样的状态；以及
-通过纤维系统的设置和实施形式的改变可以给椎间植入物定出
某些运动限制并且从某一变形起出现一极限区，在该极限区虽然继续升高的力不发生变形或在产生的力矩时不发生植入物的继续倾斜。
在脊椎柱的一载荷产生的轴向压缩力经由两端板传到中心部分上。这使位于两端板之间的中心部分、特别是在其中设有的易感受的弹性的成型体变形成使中心部分径向膨胀。该中心部分的膨胀由围绕中心部分的纤维系统限制并且产生的径向定向的压力可以由纤维系统作为拉力承受。因此可以给中心部分的一继续的不利的膨胀定出极限。通过纤维系统在两盖板中的锚定即使在最大的载荷下也保持椎间植入物是稳定的并且纤维系统也能够经受住显著的拉力。
在一种优选的实施形式中，整个纤维系统置入到弹性的外壳体中，从而纤维系统不必一定要由一生物相容的材料构成。
在另一种实施形式中，纤维系统只部分地在弹性的外壳体中置入，其中纤维系统具有一个关于中心轴线的径向厚度δ，而弹性的外壳体具有一个径向厚度d，并且比例δ/d×100％在80％与350％之间的范围内。因此可达到的优点是，在邻接的椎骨体的屈曲/伸展运动或侧向弯曲时产生的大的相对运动时在各盖板的周边区域内不受弹性的外壳体的大的阻力并因此在外壳体中形成裂缝的危险是微小的。
纤维系统在弹性的外壳体中的置入在不同的实施形式中可以这样构成，即
a)纤维系统相对于外壳体的弹性材料是可活动的；或
b)纤维系统相对于外壳体的弹性材料是固定的。
在另一种实施形式中，整个的纤维系统锚定在各盖板上，从而可由纤维系统承担较大的拉力并且椎间植入物由此得到一高的抗扭刚度。
在另一种实施形式中，容纳纤维系统的外壳体由一种弹性的生物相容的材料，优选由一种特别是以聚氨酯(PUR)为基的弹性体制成。但也可以采用硅橡胶、聚乙烯、聚碳酸酯聚氨酯(PCU)或聚对苯二甲酸乙二酯(PET)。
在另一种实施形式中，中心部分至少部分地填充有一种不可压缩的介质，优选液体。
在另一种实施形式中，中心部分包括一个不可压缩的液体芯部和一个绕其设置的弹性成型体，其中液体例如可以容纳于一个在成型体内设置的腔中。借此可达到的优点是，通过液芯部达到椎间植入物类似于生理的椎间盘的机械特性。通过弹性的中心部分的轴向变形导致不可压缩的液体的径向伸展并且以后导致中心部分含有纤维系统的壁的伸展。通过中心部分的壁的径向伸展或膨胀产生的拉力基本上由各纤维承受。
纤维在盖板上的锚定可以例如按以下方式实现：
a)机械地通过各槽引导构成为连续纤维的各纤维并沿各盖板的外表面从一个槽到另一个槽引导构成为连续纤维的各纤维。各纤维这样与各盖板一起围绕中心部分。通过纤维在槽中的引导将纤维系统这样锚定在盖板上，即在纤维上作用拉力时没有纤维沿侧面的滑动是可能的，因为各纤维只承受拉力；
b)机械地通过各槽的楔形构造，以致从盖板到盖板延伸的各纤维可固定于各槽中；和/或
c)通过纤维系统在各盖板上的粘结。
在本发明的椎间植入物的另一种实施形式中，每一盖板在其周边上包括一个侧面和一些在圆周上分布的径向穿入侧面的槽。属于纤维系统的各纤维通过这些槽引导。
在另一实施形式中，中心部分和纤维系统一起形锁合与各盖板相连结。
在另一种实施形式中，纤维系统通过两个盖板的外表面进行引导，从而其围绕中心部分和各盖板。
在一连续的纤维的应用情况下，其围住整个的植入物，应力有利地分布在该缠绕的全圆周上。优选将纤维系统构成为针织物、纺织物或编织物的形式。
在另一种实施形式中，容纳纤维系统的各通道通入各盖板的外表面中。
在另一种实施形式中，将中心部分构成基本上空心圆柱形的、空心棱柱形的或一旋转体、椭圆体、部分球体的形状或桶形状，并且具有共轴于中心轴线的旋转轴线。通过这样的构造可达到的优点是，邻接的椎骨体的旋转轴线的位置尽可能在相当大程度上相当于天然的椎间盘的旋转轴线。
纤维系统可以例如由UHMWPE(超高分子量聚乙烯)或也由PET(聚对苯二甲酸乙二酯)构成。
在本发明的椎间植入物的另一种实施形式中，在每一盖板上固定一用于支承在邻接的椎骨体的底板或盖板上确定的端接板，借此各具有一个横向于中心轴线设置的包括一个宏观结构部分的外表面。该宏观结构部分可以例如以齿的形式来实现。宏观结构部分允许直接在手术以后椎间植入物的最初的稳定。借此可达到在一时刻椎间植入物的机械锚定，在此时刻骨在椎间植入物上尚未发生生长。
在另一种实施形式中，织物由第一和第二纤维构成，其中第一纤维与中心轴线夹一个角度α，而第二纤维与中心轴线夹一个角度β。优选角度α或β在15°与60°之间。
在另一种实施形式中，将第一和第二纤维相互交织。
在另一种实施形式中，弹性的成型体具有一个垂直于中心轴线的横截面积FF，而中心部分具有一个垂直于中心轴线的横截面积FM并且该两横截面积的比例FF/FM在30％与65％之间。
在另一种实施形式中，弹性的成型体由一半渗透性的薄膜围绕，其中在弹性的成型体的内部优选具有生理盐溶液。
纤维系统关于中心轴线可以设置成单层的或多层的，优选2层直至6层。此外，纤维系统可以缠绕在弹性的成型体上。可以沿两不同的方向、优选以旋转对称的设置实现在弹性成型体上的缠绕。
在另一种实施形式中，可在每一盖板上固定一端接板，其具有一个横向于中心轴线设置的包括一个宏观结构部分的外表面，宏观结构部分优选为齿的形式。
各纤维的直径在0.005mm与0.025mm之间。优选由多根纤维制造一丝线(粗纱)，其中例如500-2000根纤维构成一横截面积为0.5mm2至2mm2的丝线。
在这样的实施形式中，其中纤维系统具有相互交叉的纤维部分，在病人屈曲运动(屈曲、伸展、侧向屈曲)时一纤维部分在单面被拉伸并且在剪切时切向于剪切方向延伸的纤维部分承受力。
附图说明
以下借助多个实施例的部分的示意图还要更详细地说明本发明及其进一步构成。其中：
图1本发明的椎间植入物的一种实施形式的侧视图；
图2图1中所示本发明的椎间植入物的实施形式的俯视图；
图3本发明的椎间植入物的另一种实施形式的侧视图；
图4图3中所示本发明的椎间植入物的实施形式的剖面图；
图5a本发明的椎间植入物的一种实施形式的纤维系统的透视图；
图5b图5a中所示纤维系统的俯视图；
图6a本发明的椎间植入物的一种实施形式的纤维系统的透视图；
图6b图6a中所示纤维系统的俯视图；以及
图7本发明的椎间植入物的另一种实施形式的剖面图。
具体实施方式
图1和2中示出本发明的椎间植入物1的一种实施形式，它包括一个上盖板3和一个下盖板4，各具有一个横向于中心轴线2延伸的外表面7、8并且在周边上各具有一个侧面21、22。在盖板3、4之间设置一个具有中心腔11和外壳12的中心部分10，其包括纤维系统5。为了将属于纤维系统5的各纤维6锚定在盖板3、4上，每一周边的侧面21、22包括在圆周上分布的、径向穿入侧面21、22的各槽18，从而纤维系统5可锚定于这些槽18中。在中心腔11中设置一个可弹性变形的成型体9，其具有一个不可压缩的芯部，优选为一个液体芯部13。由于液体芯部13的不可压缩性例如在一个平行于纵轴线2的盖板3、4的压缩时弹性的成型体9和外壳12与纤维系统5一起径向、亦即横向于纵轴线2膨胀，由此各纤维6受拉力。
图3和4中示出本发明的椎间植入物1的一种实施形式，它包括两个横向于中心轴线2设置的盖板3、4和一个位于其中间的可弹性变形的中心部分10。中心部分10包括一个共轴于中心轴线2的空心圆柱形外壳12和一个中心腔11。在中心腔11中设置一个弹性的成型体9，其具有一个不可压缩的芯部，优选为一个液体芯部13。成型体9由一个半渗透的薄膜围绕，而外壳12由塑料制成，其包括纤维系统5和一个弹性的由纤维系统5通过的外壳体25。端接板14、15与盖板3、4固定连结并且具有轴向外表面16、17，它们可支承在两邻接的椎骨体的端板上。纤维系统5锚定在盖板3、4上并且结合于外壳12中，且并用于承受在中心部分10上的力，这些力通过邻接端接板14、15的椎骨体施加到椎间植入物1上，亦即通过椎骨体相互相对绕中心轴线2扭转的扭转力或通过脊椎柱的侧向弯曲和/或屈曲/伸展的弯矩。例如一个由两端接板14、15平行于中心轴线2在椎间植入物1上的压缩力经由两盖板3、4传到中心部分10上。从而以后弹性成型体9横向于中心轴线2膨胀。这样的弹性成型体9的膨胀运动传到包括纤维系统5的外壳12上并由其限制。由于纤维系统5锚定在盖板3、4上，横向于中心轴线2作用的压力在纤维系统5的各纤维上引起拉力。纤维系统5在这里由塑料纤维、优选由UHMWPE纤维(超高分子量聚乙烯)或由PET(聚对苯二甲酸乙二酯)构成并且包括第一和第二纤维6a、6b的编织层，它们相互交织。其中第一纤维6a与中心轴线2夹一个角度α而第二纤维6b与中心轴线2夹一个角度β。在图中所示的本发明的椎间植入物1的实施形式中，角度α和β是同样大小的并且在15°与60°之间。在盖板3、4上借助各槽18锚定纤维6a、6b，各槽平行于中心轴线2设置在盖板3、4的圆周上，从而纤维6a、6b通过槽18并且可以沿表面7、8在一个通道19内导向下一槽18。盖板3、4由塑料制成，而在外面设置的端接板14、15由钛或钛合金制成。在外面设置的端接板14、15与盖板3、4或形锁合或摩擦锁合相连结。特别是它们彼此间可以粘结或焊接。
图5a和5b中示出本发明的椎间植入物1的一个实施形式的一个纤维系统5，其中沿端板3、4延伸的各纤维6在盖板3、4的圆形表面7、8上构成各个弦。
图6a和6b中示出本发明的椎间植入物1的一个实施形式的一个纤维系统5，其中沿端板3、4延伸的各纤维6在中心轴线2和端板3、4的极点处相交。
相对于各纤维6的对顶线设置(图6a、6b)，各纤维6作为弦(图5a、5b)沿端板3、4的表面7、8的引导具有以下优点：
-由于各纤维6的交叉点的改善的分布，特别在盖板3、4的外表面7、8与端接板14、15(图3和4)之间不会发生堆积；以及
-纤维系统5借助于缠绕技术可以相对于中心轴线2对称地制造，其中可以将椎间植入物1固定于中心轴线2与盖板3、4之间的交点。
图7中示出一种实施形式，其与图3和4中所示的实施形式的区别只在于，在中心部分10的周边上设置的外壳12包括一个弹性的由纤维系统5只部分地通过的外壳体25，其厚度α小于纤维系统5的径向厚度δ。

Claims (34)

1.具有一条中心轴线(2)的椎间植入物(1)，包括：
A)一个下盖板(3)和一个上盖板(4)，它们各具有一个横向于中心轴线(2)延伸的外表面(7、8)；
B)一个在盖板(3、4)之间设置的中心部分(10)，该中心部分具有一个包括一个纤维系统(5)的外壳(12)，其中
C)纤维系统(5)至少部分地与盖板(3、4)相连结；其特征在于，
D)外壳(12)包括一个在周边围绕中心部分(10)的弹性的外壳体(25)，该外壳体由一种均质的材料构成并且被纤维系统(5)穿过。
2.按照权利要求1所述的椎间植入物(1)，其特征在于，整个的纤维系统(5)置入到弹性的外壳体(25)中。
3.按照权利要求1所述的椎间植入物(1)，其特征在于，纤维系统(5)只部分地置入在外壳体(25)中。
4.按照权利要求3所述的椎间植入物(1)，其特征在于，纤维系统(5)关于中心轴线(2)具有一个径向厚度δ，而外壳体(25)具有一个径向厚度d，其中比例δ/d×100％在80％与350％之间的范围内。
5.按照权利要求1至4之一项所述的椎间植入物(1)，其特征在于，纤维系统(5)相对于外壳体(25)是可活动的。
6.按照权利要求1至4之一项所述的椎间植入物(1)，其特征在于，纤维系统(5)相对于外壳体是固定支承的。
7.按照权利要求1至6之一项所述的椎间植入物(1)，其特征在于，整个的纤维系统(5)与盖板(3、4)相连结。
8.按照权利要求1至7之一项所述的椎间植入物(1)，其特征在于，外壳体(25)由一种弹性的生物相容的材料，优选由一种特别是以聚氨酯为基的弹性体，或硅橡胶、聚乙烯、聚碳酸酯聚氨酯或聚对苯二甲酸乙二酯构成。
9.按照权利要求1至8之一项所述的椎间植入物(1)，其特征在于，中心部分(10)至少部分地填充有一种不可压缩的介质。
10.按照权利要求9所述的椎间植入物(1)，其特征在于，不可压缩的介质为一种液体。
11.按照权利要求10所述的椎间植入物(1)，其特征在于，中心部分(10)包括一个不可压缩的液体芯部(13)和一个绕其设置的弹性成型体(9)。
12.按照权利要求1至11之一项所述的椎间植入物(1)，其特征在于，中心部分(10)具有一个腔(11)。
13.按照权利要求1至12之一项所述的椎间植入物(1)，其特征在于，纤维系统(5)机械地锚定到盖板(3、4)上或其中。
14.按照权利要求1至12之一项所述的椎间植入物(1)，其特征在于，纤维系统(5)与盖板(3、4)粘结。
15.按照权利要求1至12之一项所述的椎间植入物(1)，其特征在于，中心部分(10)和结合的纤维系统(5)一起形锁合地与盖板(3、4)相连结。
16.按照权利要求1至15之一项所述的椎间植入物(1)，其特征在于，纤维系统(5)由一条连续纤维优选以针织物或编织物的形式构成。
17.按照权利要求1至16之一项所述的椎间植入物(1)，其特征在于，每一盖板(3、4)在其周边上包括一个侧面(21、22)和在圆周上分布的、径向穿入侧面(21、22)中的各槽(18)，并且纤维系统(5)可锚定到这些槽(18)中。
18.按照权利要求1至17之一项所述的椎间植入物(1)，其特征在于，纤维系统(5)通过两个盖板(3、4)的外表面(7、8)进行引导并且围绕中心部分(10)和两个盖板(3、4)。
19.按照权利要求18所述的椎间植入物(1)，其特征在于，用于容纳纤维系统(5)的通道(19)通入到盖板(3、4)的外表面(7、8)。
20.按照权利要求1至19之一项所述的椎间植入物(1)，其特征在于；纤维系统(5)由一种织物构成。
21.按照权利要求1至20之一项所述的椎间植入物(1)，其特征在于，中心部分(10)构成基本上空心圆柱形的、空心棱柱形的或一个旋转体、一个椭圆体、一个部分球体的形状或一个桶形状，并且具有共轴于中心轴线(2)的旋转轴线。
22.按照权利要求20或21所述的椎间植入物(1)，其特征在于，织物由第一和第二纤维(6a/6b)构成并且第一纤维(6a)与中心轴线(2)夹一个角度α，而第二纤维(6b)与中心轴线(2)夹一个角度β。
23.按照权利要求22所述的椎间植入物(1)，其特征在于，第一和第二纤维(6a、6b)相互交织。
24.按照权利要求11至23之一项所述的椎间植入物(1)，其特征在于，弹性的成型体(9)具有一个垂直于中心轴线(2)的横截面积FF，中心部分(10)具有一个垂直于中心轴线(2)的横截面积FM并且该两横截面积的比例FF/FM在30％与65％之间。
25.按照权利要求22至24之一项所述的椎间植入物(1)，其特征在于，角度α在15°与60°之间。
26.按照权利要求22至25之一项所述的椎间植入物(1)，其特征在于，角度β在15°与60°之间。
27.按照权利要求11至26之一项所述的椎间植入物(1)，其特征在于，弹性的成型体(9)由一个半渗透性的薄膜围绕并且在弹性的成型体(9)的内部优选具有生理盐溶液。
28.按照权利要求1至27之一项所述的椎间植入物(1)，其特征在于，纤维系统(5)关于中心轴线(2)设置成单层的。
29.按照权利要求1至27之一项所述的椎间植入物(1)，其特征在于，纤维系统(5)关于中心轴线(2)设置成多层的，优选2层至6层。
30.按照权利要求11至29之一项所述的椎间植入物(1)，其特征在于，纤维系统(5)缠绕在弹性的成型体(9)上。
31.按照权利要求30所述的椎间植入物(1)，其特征在于，纤维系统(5)沿两个不同的方向缠绕在弹性的成型体(9)上，优选按旋转对称的布置。
32.按照权利要求1至31之一项所述的椎间植入物(1)，其特征在于，纤维系统(5)由UHMWPE(超高分子量聚乙烯)构成。
33.按照权利要求1至32之一项所述的椎间植入物(1)，其特征在于，可在每一盖板(3、4)上固定一端接板(14、15)，该端接板具有一个横向于中心轴线(2)设置的具有一个宏观结构部分的外表面，宏观结构部分优选为齿的形式。
34.按照权利要求1至23之一项所述的椎间植入物(1)，其特征在于，各纤维的直径在0.005mm与0.025mm之间的范围内。
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CN100484499C (zh) 2009-05-06
DE50308869D1 (de) 2008-01-31
US20100280615A1 (en) 2010-11-04
JP4240399B2 (ja) 2009-03-18
CA2534169C (en) 2010-10-12
AU2003213975B2 (en) 2008-06-26
JP2006522613A (ja) 2006-10-05
KR20060011832A (ko) 2006-02-03
US20060265075A1 (en) 2006-11-23
US8690946B2 (en) 2014-04-08
ES2297133T3 (es) 2008-05-01
KR101007648B1 (ko) 2011-01-13
US20130138215A1 (en) 2013-05-30
US20090054989A1 (en) 2009-02-26
WO2004089257A1 (de) 2004-10-21
US8382838B2 (en) 2013-02-26
ATE381305T1 (de) 2008-01-15
EP1626684A1 (de) 2006-02-22
US9089439B2 (en) 2015-07-28
BR0318245A (pt) 2006-04-04
DE20321645U1 (de) 2008-08-21
AU2003213975A1 (en) 2004-11-01
US20140172108A1 (en) 2014-06-19
US7429270B2 (en) 2008-09-30
EP1626684B1 (de) 2007-12-19
CA2534169A1 (en) 2004-10-21

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