CN100591305C - 椎间植入物以及用于腰脊柱融合的外科手术方法 - Google Patents

椎间植入物以及用于腰脊柱融合的外科手术方法 Download PDF

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CN100591305C
CN100591305C CN200480041640A CN200480041640A CN100591305C CN 100591305 C CN100591305 C CN 100591305C CN 200480041640 A CN200480041640 A CN 200480041640A CN 200480041640 A CN200480041640 A CN 200480041640A CN 100591305 C CN100591305 C CN 100591305C
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intervertebral implant
head
base structure
peripheral surface
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小弗朗茨·科波夫
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Abstract

本发明涉及一种椎间植入物以及用于腰脊柱融合的外科手术方法。椎间植入物以已知的方式具有带有至少圆锥形部分和外螺纹的头部。在头部上形成有中央部分，它们由多个从头部延伸到基础结构的支柱构成。这样，在头部、支柱和基础结构之间的大面积的窗保持敞开。根据本发明头部的外螺纹形成在圆锥形部分上并且头部的外端区域由保护突起部构成，该突出部从外面看突出地弯曲并且没有锋利的边缘。通过根据本发明的椎间植入物在没有损伤相邻的静脉或者大动脉的情况下特别能够实现相邻椎体的腹侧周边的完全撑开牵引。同时通过椎间植入物的几何尺寸的选择调整脊椎前弯。此外本发明涉及一种使用这种椎间植入物的用于腰脊柱融合的外科手术方法。

Description

椎间植入物以及用于腰脊柱融合的外科手术方法
技术领域
本发明涉及一种椎间植入物。它包括：
a)头部，其具有锥形部分和外螺纹；
b)在头部上形成同样具有外螺纹的中央部分；
c)在中央部分上形成的基础结构；
其中
d)中央部分由多个从头部延伸到基础结构的支柱构成，所以在头部、支柱和基础结构之间大面积的窗保持敞开。
以及一种用于腰脊柱融合的外科手术方法，其中在两个相邻椎体之间的椎间空间中插入至少一个椎间植入物。
背景技术
在DE 199 57 339 C2中对上述类型的椎间植入物进行了说明。其有意识地摒弃了以前已知的椎间植入物的套筒形状，取而代之使用带有窄支柱的中央部分，它们使窗尽可能大地敞开。对于在椎间植入物中装入的骨松质(Spogiosa)，能够以这样的方式分离出从一个椎体到另一个椎体的大面积的直接路径，这实现特别好的摩擦连接并且加速骨生成。此外，使用这种类型的椎间植入物在手术期间和之后更易于进行X光检查。
在已知的椎间植入物中，头部具有带外螺纹的圆柱形部分，以及在端部区域连接的锥形的无螺纹部分。通过这样的椎间植入物，不能无风险地进行尤其是椎体的腹侧周边的完全撑开牵引，因为不能完全排除相邻腔静脉和大动脉受到损伤的危险。
发明内容
因此本发明的目的在于设计一种在开头所述类型的椎间植入物，其也适合用于撑开牵引，特别是在椎体的腹侧区域中。
根据本发明，该目的如此实现，即
e)头部的外螺纹形成在圆锥形部分上；
f)头部的外端区域由保护突起部构成，其从外面看时突出地弯曲并且没有锋利的边缘。
根据本发明的椎间植入物能够通过它头部的外螺纹旋入到椎体的腹侧周边上的致密层中，其中由于存在圆锥度，发生椎体相应的撑开牵引。在这种情况下，头部的保护突起部移动越过椎体的腹侧边缘，但是由于它没有锋利边缘，相邻血管不会受伤而总是不留出血地将它们从椎体中略微挤开。根据本发明的椎间植入物能够精确地定位在椎体边缘上。
头部的圆锥形部分应该具有至少7mm的轴向延伸，以便能在撑开牵引过程中传输足够的力到椎体并到达椎体的腹侧周边上。
由于相同的原因，有利的是，在头部上的外螺纹具有至少三个完整的螺纹导程。
头部的保护突起部应该具有至少5mm的轴向延伸，以便保证实际上所有锋利的边缘(螺纹导程也属于锋利边缘)总是与相邻血管隔开足够的距离。
保护突起部具有封闭盖的形状或者也可以是环形的并且具有中央通孔。
根据本发明的椎间植入物的基础结构优选地具有至少5mm的轴向延伸。这考虑了实际的解剖学构造，即椎体脊背侧上的致密层比在腹侧上的薄。
基础结构具体是板。
它应该具有用于旋入器械的施用装置，其中这样的实施形式是优选的，即该施用装置仅在外科医生的主动操作下连接于旋入器械，并且同样可仅在外科医生的主动操作下拆除。这种施用装置是已知的。
由头部的圆锥形部分的圆锥形周向表面和虚拟的同心圆柱体的周向表面构成的角度(α)在10°和20°之间，优选为15°，而与个体病人的数据无关。
根据本发明的椎间植入物的一个特别有利的实施形式的特征在于，中央部分和基础结构相对于头部的锥形部分成相反的锥形。因此中央部分和基础部分的圆锥度确定其间插入椎间植入物的两个椎体的脊柱前弯。
根据一般的解剖条件，通常，有选择地为中央部分和基础结构准备两个圆锥角度就足够了：由中央部分和基础结构的锥形周向表面与虚拟的同心圆柱体的周向表面构成的角度(β)在一个实施形式中是大约3°并且在另一个实施形式中是大约6°。
椎间植入物能够由不同的材料制成，特别是由不锈钢、碳-陶瓷材料、铝合金、钛、塑料材料特别是聚异氰酸盐或类似物制成。
但是根据本发明的椎间植入物也可以由生物吸附材料制成，特别是聚乳酸(Polyaktid)。
如果椎间植入物在至少一个轴向区域中具有非旋转对称的横截面形状，能够确保它在旋入后不会无意地转动。在这种情况下，特别有利的是，与椎体的致密层的脊背侧区域共同作用的基础结构本身具有非旋转对称的横截面形状。
如果保护突起部被磨光，那么椎间植入物尤其不会损伤到血管。
此外本发明的目的还在于，公开一种在开头所述类型的保护患者的用于腰脊柱融合的外科手术方法。
该目的是通过一种方法实现的，该方法具有下列步骤：
a)在局部切除小的脊椎关节的情况下从脊背侧面以微型外科手术的方式打开通往椎间空间的通道；
b)除去椎间空间的盖板和底板的软骨部分；
c)在椎间空间的脊背侧区域切割螺纹；
d)利用撑开牵引器械预先撑开牵引椎间空间；
e)利用隔开元件保持预先撑开牵引并除去撑开牵引器械；
f)将第一椎间植入物旋入到椎间空间的螺纹中；
g)对第二椎间植入物重复步骤a)至f)，该第二椎间植入物与第一椎间植入物隔开一定距离地插入。
根据本发明的外科手术由于其显微外科设计以及其从脊背侧的施加而能够保护患者并且仅仅产生非常小的伤口。因此显著减小了感染的危险。患者承受非常小的疼痛并且显著缩短在住院时间。
如果患者还没有预先进行手术，则要求在步骤a)之后使黄韧带(Ligamentum Flavum)从外向内变薄。但是在这种情况下能保留了内部区域，所以很大程度上避免了瘢痕形成。
在步骤b)之后，能够更新露出的骨骼部分，即磨刮其表面，这促进了与引入椎间空间的骨松质的粘合。
椎间植入物本身应该在引入椎间空间之前被填充骨松质。
同样椎间空间本身优选地最晚在第二个椎间植入物引入之前被填充骨松质。
根据本发明的方法在使用根据权利要求1-13中任一项所述的椎间植入物时是特别有益的，其中将所述椎间植入物在特别是腹侧区域撑开牵引的情况下旋入，直到在保护突起部和头部的圆锥形区域之间的过渡线达到在椎体的腹侧周边的侧视图中的顶点的高度上。在根据本发明的方法的这种构造中，也可以要求的方式无风险地撑开牵引尤其是椎体的腹侧区域。
在椎间植入物旋入时，可以测量转矩。如果转矩低于一预定值，这意味着所使用的椎间植入物的最大直径太小，并且所实现的撑开牵引是不足的。那么选择另一个带有更大的最大直径的椎间植入物。
附图说明
下面根据附图详细地说明本发明的实施例；其中：
图1示出带有尺寸的椎间植入物的侧视图；
图2示出图1的椎间植入物的仰视图；
图3示意性示出两个并排植入到两个椎体之间的椎间植入物的俯视图；以及
图4以放大比例示出在两个所示的剖切椎体之间的椎间植入物的侧视图。
具体实施方式
首先参考图1。该图示出整体用附图标记1表示的椎间植入物。它包括在植入状态中在腹侧示出的头部2以及在植入状态中在脊背侧示出的底板3，它们通过四个细长的支柱5、6、7和8互相连接。在支柱5、6、7、8，头部2和底板3之间保持有大面积的窗9、10、11、12。
椎间植入物1的头部2包括带有外螺纹14的圆锥形部分13，以及连接于圆锥形部分13并且构成椎间植入物1的腹侧端并且从外面看来突出的保护盖15。在所示的实施例中是球圆顶面的保护盖15由于下面将说明的原因被磨光；因此该保护盖根本没有锋利的边缘。保护盖15的拱顶高D3至少是4-5mm；对此的原因同样在下面进一步说明。圆锥形部分13具有轴向的长度D4，其不小于7mm。外螺纹14在圆锥形部分13内具有至少三个完整的导程。圆锥形部分13的锥体周向表面与虚拟圆柱体的周向表面构成的角度α(相应于半个圆锥角)在10°和20°之间，优选地在大约15°。
同样支柱5、6、7、8位于虚拟圆锥面上，但是该圆锥面沿相反的方向从头部2的圆锥形区域13朝椎间植入物1的在图1底部的脊背侧端逐渐变小。虚拟圆锥体的锥形周向表面与圆柱体的周向表面构成的角度β(相应于半个圆锥角)根据椎间植入物1将插入的椎体是大约6°或者大约3°。同样支柱5、6、7、8具有外螺纹16，该外螺纹构成为在头部2的圆锥形区域13上的外螺纹14的延伸部分。
支柱5、6、7、8整体过渡到底板3的圆形的角部，具体如图2所示。此外底板3的仰视图基本上是正方形的。支柱5、6、7、8的外螺纹16延续到底板3的圆形角部的外螺纹17上。
如图2所示，用于旋入器械的施用装置插入底板3的下端并且在所示的情况下呈十字槽18的形式。在附图中未示出的相关旋入器械具有互补的十字形的轴向延伸的凸起并且能够卡在锁定装置19中，该锁定装置在附图中示意性地表示为圆孔。锁定装置19设计成旋入器械和十字槽18之间的连接的建立要求外科医生的主动操作，并且将旋入器械相反地从底板3上拿开能够仅在外科医生的主动操作并且有意识的情况下进行。这种类型的连接是已知的，因此此处无需再详细地说明。
底板3的轴向延伸D5应该不小于4mm。
如前面所述的，椎间植入物1在病人和病人之间基本上没有区别。但是个体病人的数据以下面的方式汇合到椎间植入物1的尺寸中并且必须在外科手术前从CT扫描或者X光照片取得。
具体如图4所示，在底板3的脊背侧的外端面和头部2的圆锥形区域13与磨光保护盖15之间的过渡线20之间的轴向距离D1相当于在侧视图中的要被连接的椎体30、31的脊背侧外边缘和椎体30、31的腹侧边缘的相对顶点32、33之间的距离。因此椎间植入物1的植入位置是这样的，脊背侧的外端面基本与椎体30、31的脊背侧边缘对准，而在椎间植入物1的头部2上的过渡线20连接两个椎体30、31的顶点32、33。在这种情况下，头部2的保护盖15在腹侧伸出椎体30、31的腹侧边缘。
椎间植入物1能够由不同的材料制成。一方面，如已经在上述的DE199 57 339 C2中所述，可考虑不锈钢或者碳-陶瓷材料。同样铝合金、钛以及某些塑料特别是聚异氰酸盐(PIC)适合于作为永久保留在体内的材料。然而同样可以使用生物吸附(bioresorbierbare)材料，如特别是聚乳酸，即由聚乙烯(L-Laktid-co-D，L-Laktid)构成的共聚物，这些材料例如以Telamon的商标名称销售。
因此，对于不同的病人必须准备椎间植入物1的数据组，它们在尺寸D1的大小上互相不同。在这里设计2mm的级差通常是足够的，其中具体在实践中可以考虑28、30、32、34、36mm的尺寸D1。
从上面的说明中可以得知，椎间植入物1的最大直径D2出现在头部2和支柱5、6、7之间的过渡线21上。它对应于相邻椎体30、31之间所希望的撑开牵引并且能够从例如由相邻健康部分的X光片中获得。同样关于尺寸D2也需要一整个系列由外科医生准备好的椎间植入物1的数据。2mm的级差也是足够的。在实践中10、12、14和16mm的尺寸D2是适合的。
在椎间植入物1的未在附图中示出的实施例中，腹侧的端部不是通过封闭的保护盖而是通过带有通孔的从外面看来凸起形成的环构成，该环应该不大于5mm。该保护环的沿腹侧方向示出的外表面应该同样被磨光。
外科医生利用上述的每次需要两个的椎间植入物1以下述的方式进行融合：
首先手术前从CT扫描或者X光照片中计算出要使用的椎间植入物1的独特的数据D1和D2。根据互相要连接的椎体所希望的脊柱前弯选择角度β。
该手术是从脊背侧进行微型外科手术。通过局部切除小的脊椎关节(joint)获得必要的通往椎间空间的通道，其中对没有预先动手术的病人可尽可能保护黄韧带。这仅需要从外向内使之略微变薄，所以内层得到了保留。以这种方式避免瘢痕形成。
然后小心地将盖板和底板的软骨部分从椎间空间中取出。在这种情况下骨骼被“更新”，也就是说，表面被磨薄了，其中没有损伤它的承载能力。此后利用基本上放置在脊背侧的椎边缘的撑开牵引器械进行椎体30、31的预先撑开牵引。当现在撑开牵引器械再次被拆除时，如此实现的预先撑开牵引通过在椎间空间中引入设有两个隔开片(隔开元件)的套筒而得到保持。
然后穿过该套筒在椎间空间的脊背侧部分中切割有螺纹。带有头部2的第一椎间植入物1首先通过套筒，并且通过转动与椎体30、31的前面切割的螺纹拧紧，所以它在轴向上沿腹侧的方向运动。椎间植入物1预先用骨松质填充。
现在转动椎间植入物1直到在椎间植入物1的头部2上的外螺纹14到达两个椎体30、31的腹侧周边的致密层。在继续转动椎间植入物1时，外螺纹14切割进椎体30、31的腹侧边缘的致密层中，其中头部2的圆锥形区域13的圆锥形形状引起椎体30、31的腹侧边缘相应的撑开牵引。椎间植入物1的旋入运动在X光的观察下延伸到过渡线20到达位于两个椎体30、31的顶点32、33构成的区域中。不能进行进一步的运动。直到这个时间点，头部2的保护盖15已潜在地沿腹侧的方向推开在该方向上延伸的静脉和大动脉，但是没有损伤它们，因为它没有锋利的边缘。
现在剩下的椎间空间用骨松质填充并且第二个椎间植入物1′以上面所述的方式插入到第一椎间植入物1的旁边(参看图3)。在两个椎间植入物1、1′之间的距离应该不小于1cm。同样第二椎间植入物1′在插入之前用骨松质填充。
在两个椎间植入物1、1′的外螺纹14旋入时，测量为此所要求的转矩。如果该转矩低于一特定值，这是一个信号，即从数据记录中选择的椎间植入物1的尺寸D2太小；那么椎间植入物1必须替换为尺寸D2较大的椎间植入物1。
在没有椎体的腹侧位移的情况下实现充分的撑开牵引时，不需要其它的措施。因此在仅插入椎间植入物1、1′的情况下使用“孤立(stand alone)”技术就足够了。否则另外通过内固定器(Fixateur Interne)进行附加固定(Vergurtung)。

Claims (25)

1.一种椎间植入物，包括：
a)头部(2)，其具有圆锥形部分(13)和外螺纹(14)；
b)在头部(2)上形成的中央部分(5、6、7、8)，所述中央部分同样具有外螺纹(16)；
c)在中央部分(5、6、7、8)上形成的基础结构(3)，
其中
d)中央部分(5、6、7、8)由多个从头部(2)延伸到基础结构(3)的支柱构成，以便在头部(2)、支柱(5、6、7、8)和基础结构(3)之间的大面积的窗(9、10、11、12)保持敞开，
其特征在于，
e)头部(2)的外螺纹(14)形成在圆锥形部分(13)上；
f)头部(2)的外端区域由保护突起部(15)构成，所述保护突起部从外面看突出地弯曲并且没有锋利的边缘；
g)圆锥形部分(13)沿从基础结构(3)到头部(2)的方向逐渐缩小。
2.如权利要求1所述的椎间植入物，其特征在于，头部(2)的圆锥形部分(13)具有至少7mm的轴向延伸(D4)。
3.如权利要求1或2所述的椎间植入物，其特征在于，在头部(2)上的外螺纹(14)具有至少三个完整的螺纹导程。
4.如权利要求1或2所述的椎间植入物，其特征在于，头部(2)的保护突起部(15)具有至少5mm的轴向延伸(D3)。
5.如权利要求1或2所述的椎间植入物，其特征在于，保护突起部(15)呈封闭盖的形式。
6.如权利要求1或2所述的椎间植入物，其特征在于，保护突起部是环形的并且具有中央通孔。
7.如权利要求1或2所述的椎间植入物，其特征在于，基础结构(3)具有至少5mm的轴向延伸(D5)。
8.如权利要求1或2所述的椎间植入物，其特征在于，基础结构(3)是板。
9.如权利要求1或2所述的椎间植入物，其特征在于，在基础结构(3)上设有用于旋入器械的施用装置(18、19)。
10.如权利要求1或2所述的椎间植入物，其特征在于，由头部(2)的圆锥形部分(13)的圆锥形周向表面和虚拟的同心圆柱体的周向表面构成的角度(α)位于10°和20°之间。
11.如权利要求10所述的椎间植入物，其特征在于，由头部(2)的圆锥形部分(13)的圆锥形周向表面和虚拟的同心圆柱体的周向表面构成的角度(α)为15°。
12.如权利要求1或2所述的椎间植入物，其特征在于，中央部分(5、6、7、8)和基础结构(3)相对于头部(2)的锥形部分(13)成相反的锥形。
13.如权利要求12所述的椎间植入物，其特征在于，由中央部分(5、6、7、8)和基础结构(3)的锥形周向表面与虚拟的同心圆柱体的周向表面构成的角度(β)是3°。
14.如权利要求12所述的椎间植入物，其特征在于，由中央部分(5、6、7、8)和基础结构(3)的锥形周向表面与虚拟的同心圆柱体的周向表面构成的角度(β)是6°。
15.如权利要求1或2所述的椎间植入物，其特征在于，它由不锈钢制成。
16.如权利要求1或2所述的椎间植入物，其特征在于，它由碳-陶瓷材料制成。
17.如权利要求1或2所述的椎间植入物，其特征在于，它由铝合金制成。
18.如权利要求1或2所述的椎间植入物，其特征在于，它由钛制成。
19.如权利要求1或2所述的椎间植入物，其特征在于，它由塑料材料制成。
20.如权利要求19所述的椎间植入物，其特征在于，它由聚异氰酸盐制成。
21.如权利要求1或2所述的椎间植入物，其特征在于，它由生物吸附材料制成。
22.如权利要求21所述的椎间植入物，其特征在于，其由聚乳酸制成。
23.如权利要求1或2所述的椎间植入物，其特征在于，它在至少一个轴向区域中具有非旋转对称的横截面形状。
24.如权利要求23所述的椎间植入物，其特征在于，基础结构(3)具有非旋转对称的横截面形状。
25.如权利要求1或2所述的椎间植入物，其特征在于，保护突起部(15)被磨光。
CN200480041640A 2004-02-13 2004-02-13 椎间植入物以及用于腰脊柱融合的外科手术方法 Expired - Fee Related CN100591305C (zh)

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AU2004316340A1 (en) 2005-09-09
CA2555405C (en) 2011-01-18
DE502004011964D1 (de) 2011-01-13
CA2555405A1 (en) 2005-09-09
EP1713421B1 (de) 2010-12-01
EP1713421A1 (de) 2006-10-25
JP2007521893A (ja) 2007-08-09
US8460380B2 (en) 2013-06-11
AU2004316340B2 (en) 2011-03-10
ATE489919T1 (de) 2010-12-15
ES2357270T3 (es) 2011-04-20
WO2005082292A1 (de) 2005-09-09
US20070055374A1 (en) 2007-03-08
CN1913845A (zh) 2007-02-14
BRPI0418538A (pt) 2007-05-22
JP4620689B2 (ja) 2011-01-26
AU2004316340A2 (en) 2005-09-09
DK1713421T3 (da) 2011-03-21

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