CN101574278B - 用于脊柱的动态稳固的杆状植入物 - Google Patents

用于脊柱的动态稳固的杆状植入物 Download PDF

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CN101574278B
CN101574278B CN200910132270.7A CN200910132270A CN101574278B CN 101574278 B CN101574278 B CN 101574278B CN 200910132270 A CN200910132270 A CN 200910132270A CN 101574278 B CN101574278 B CN 101574278B
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shaped implant
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L·比德尔曼
W·马蒂斯
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Biedermann Technologies GmbH and Co KG
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    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/7037—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other wherein pivoting is blocked when the rod is clamped

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Abstract

本发明提供了一种尤其用于脊柱的动态稳固的杆状植入物(1)，所述杆状植入物(1)的至少一部分包括形成基体(3)的挠性第一材料，包括由第二材料制造的至少一个纤维的挠性结构(2)嵌入所述基体(3)中。所述杆状植入物可以沿着杆状植入物的纵轴被压缩和伸展，同时它提供高抗扭刚度。

Description

用于脊柱的动态稳固的杆状植入物
技术领域
本发明涉及尤其用于脊柱的动态稳固的杆状植入物。所述杆状植入物包括由形成基体的挠性第一材料制造的至少一部分，包括由第二材料制造的至少一个纤维的挠性结构嵌入所述基体中。
背景技术
由塑性材料制造的用于脊柱的动态稳固的杆状植入物例如从美国文献US2007／0093820A1，US2007／0161999A1和US2007／0270843A1获知。
US2006／0142758A1描述了一种用于脊柱固定系统的联接元件，所述联接元件至少部分地由聚合材料制造的支撑件和与所述支撑件基本同轴的弯曲或非弯曲杆组成。所述杆例如由具有轴线和匝的螺旋弹簧制造，所述匝至少部分地嵌入由聚合材料制造的支撑件中。所述螺旋弹簧例如由金属或金属合金制造。联接元件的结构允许压缩和撑开，以便允许脊柱的动态稳固。
发明内容
本发明的目标是提供一种尤其用于脊柱的动态稳固的杆状植入物，其允许由所述植入物稳固的脊柱运动节段沿预定方向运动，同时防止或抑制沿其它方向运动。
根据本发明，提供了一种用于脊柱的动态稳固的杆状植入物，所述杆状植入物的至少一部分包括形成基体的挠性第一材料，包括由第二材料制造的至少一个纤维的挠性结构嵌入所述基体中，其特征在于，所述挠性结构包括同轴网络状的内结构和围绕内结构布置的同轴网络状的外结构；所述内结构和外结构相对于彼此旋转180°。
根据本发明的杆状植入物具有挠性，该挠性取决于作用在由植入物稳固的椎骨之间的力的方向。当扭力作用在杆上时它表现出特别刚性的特性，而当轴向压缩或张力作用在植入物上时它分别允许轴向压缩或伸展。
可以根据临床要求通过选择由纤维形成的合适挠性结构，特别地设计杆状植入物的挠性性质。
附图说明
结合附图从实施例的以下详细描述将显而易见本发明的进一步特征和优点。在图中：
图1显示了杆状植入物的第一实施例的示意性侧视图。
图2示意性地显示了垂直于杆轴线的根据图1的植入物的截面。
图3显示了根据图1的植入物的示意性透视图。
图4a显示了图1的杆状植入物的内挠性结构的第一例子的透视图。
图4b显示了根据图4a的第一内挠性结构的侧视图。
图5a显示了图1的杆状植入物的外挠性结构的第一例子的透视图。
图5b显示了图5a的外挠性结构的侧视图。
图6a显示了图4a-5b的组合式内和外挠性结构的透视图。
图6b显示了图6a的组合式内和外挠性结构的侧视图。
图7显示了根据图1-6b的杆状植入物连同单轴椎弓根螺钉的分解图。
图8显示了处于组装状态的根据图7的杆状植入物和单轴螺钉的截面图，所述截面垂直于杆轴线获得。
图9显示了处于组装状态的图7的单轴螺钉与杆状植入物的截面图，所述截面沿着杆轴线获得。
图10显示了处于组装状态的多轴椎弓根螺钉连同根据图1-6b的杆状植入物的截面图，所述截面垂直于杆轴线获得。
图11在截面中显示了多轴螺钉与杆状植入物，所述截面沿着杆轴线获得。
图12显示了处于组装状态的图10和11的多轴螺钉的透视图。
图13-15显示了杆状植入物连同两个椎弓根螺钉，所述椎弓根螺钉固定在相邻椎骨中，以分别将脊柱运动节段稳固在椎骨的中立、屈曲和伸展位置。
图16显示了处于中立状态的杆状植入物的示意性侧视图。
图17显示了在轴向压缩力作用下的杆状植入物的示意性侧视图。
图18显示了在扭力作用下的杆状植入物。
图19a-19c分别显示了根据改进实施例的挠性结构的透视图、截面图和侧视图。
图20a和20b分别显示了进一步改进实施例的挠性结构的透视图和侧视图。
具体实施方式
图1-3以示意性侧视图、横截面图和透视图显示了根据第一实施例的杆状植入物。杆状植入物1为大体圆柱形形状，具有外径D。它由嵌入聚合材料的基体3中的挠性结构2组成。挠性材料表现出挠性并且优选地为弹性体。合适的弹性体材料的例子是生物相容的聚氨酯或聚碳酸酯型聚氨酯(PCU)。杆状植入物的外径D被设计成使得杆状植入物可以被固定在例如椎弓根螺钉的接收部分中。聚合材料的挠性通常是各向同性的。为了将方向依赖性的特定挠性提供给杆状植入物，提供挠性结构2。尤其从图2和4a-5b可以看出，根据第一实施例的挠性结构2包括内结构2a和外结构2b。内结构2a包括与杆状植入物的纵轴L同轴布置的四个螺旋2a1、2a2、2a3和2a4。内结构2a具有对于所有四个螺旋来说相同的第一直径d1。螺旋2a1-2a4相对于彼此旋转90°。第一内结构2a由此形成中空圆柱形网状结构。
在图5a-5b中可以看出，外结构2b类似地包括也与纵轴L同轴布置并且相对于彼此旋转90°的四个螺旋2b1、2b2、2b3和2b4。外结构的螺旋的直径d2大于内结构的螺旋的直径d1但是小于杆状植入物1的外径D。外结构2b相对于内结构2a旋转180°。外结构2b也形成中空圆柱形网络状或网状结构。在图6a，6b和1-3中可以看出，在杆状植入物中外结构2b包围内结构2a。
螺旋由纤维制造，所述纤维沿纤维伸展的方向具有高强度。纤维的类弹簧性质例如拉伸强度和压缩强度由纤维的几何形状限定。因此，螺旋的绕组的距离和数量、纤维的厚度以及直径d1和d2限定螺旋和因此整个挠性结构2的挠性特性。
纤维的材料优选地为聚合物，例如聚丙烯或类似材料。然而，也可以使用碳或凯夫拉尔纤维。内结构和外结构的螺旋的材料可以相同或者可以不同以提供特定性质。纤维的弹性模量与聚合物基体的弹性模量之间的差异小于金属弹簧与聚合物基体之间的差异。所以在负荷期间在聚合物基体内纤维松弛的风险小或不存在。
例如通过首先组装内结构和外结构，并且然后围绕整个挠性结构2注射模塑聚合物基体，使得挠性结构2被嵌入聚合物基体3中，从而制造杆状植入物1。
图7-9显示了杆状植入物在单轴椎弓根螺钉中的固定。椎弓根螺钉5包括螺纹柄部6和在螺纹柄部6的一端形成的接收部分7。接收部分7为大体圆柱形并且包括U形凹窝8，所述凹窝8沿螺纹柄部的方向从自由端延伸，由此形成两个自由支脚，内螺纹9设在所述自由支脚上。在U形凹窝的底部设有横交于杆状植入物的纵轴L延伸的肋的形式的啮合结构10。为了固定提供了固定螺钉11，所述固定螺钉11可以被拧入接收部分7的内螺纹9内。固定螺钉11在它面对U形植入物1的侧面处包括啮合结构12，如图8和9中所示，所述啮合结构12可以是环状突出部。
在使用中至少两个椎弓根螺钉5被拧入相邻椎骨中，并且杆状植入物1被插入并由固定螺钉固定。接收部分的啮合结构10和固定螺钉的啮合结构12压在杆状植入物1上，由此以如下这样的方式变形聚合物基体3的表面：在啮合结构和聚合物基体之间产生将杆状植入物安全保持就位的部分形状配合连接。啮合结构的尺寸被设计成使得当上紧固定螺钉11时杆状植入物1的挠性结构不会变形。
图10-12显示了杆状植入物在多轴椎弓根螺钉中的固定。多轴椎弓根螺钉15包括带有螺纹柄部和球形头部16a的螺钉元件16和接收部分17。接收部分17为大体圆柱形并且包括U形凹窝18和逐渐变细到开口20内的同轴腔孔19，螺钉元件16的头部16a被保持在所述开口20中，使得它可以相对于接收部分17枢转。借助于U形凹窝18形成包括内螺纹21的两个支脚。提供了压力元件22，压力可以借助于所述压力元件22被施加在头部16a上以固定头部16a。压力元件22可以被插入腔孔19内，并且被设计成接收杆状植入物1。提供了固定螺钉23，所述固定螺钉23在它面对杆状植入物1的侧面处包括啮合结构24。
在使用中，至少两个椎弓根螺钉被拧入相邻椎骨中，接收部分17被对准以接收杆状植入物，然后杆状植入物由固定螺钉23固定。通过将压力施加到压力元件22上，并且头部16a被固定就位。同时杆状植入物被固定在接收部分中。
图13-15显示了固定到两个多轴椎弓根螺钉15、15′的杆状植入物1，所述椎弓根螺钉15、15′被锚固在将椎间盘103封闭在彼此之间的相邻椎骨101、102的椎弓根中。图13显示了中立位置。在该位置中挠性结构2和杆状植入物的聚合物基体既未压缩也未伸展。图14显示了脊柱的屈曲状态，其中椎弓根和因此椎弓根螺钉的距离变得比在中立位置中更大。作用在杆状植入物上的张力导致内结构和外结构2a、2b连同周围的聚合物基体一起伸展。图15显示了脊柱的伸展状态，其中椎弓根彼此接近，使得椎弓根螺钉之间的距离变得比在中立位置中更小。该压缩力导致内结构和外结构连同聚合物基体一起被压缩，使得杆状植入物变得更短。
图16示意性地显示了处于中立位置的杆状植入物的长度，并且图14显示了杆状植入物的长度的压缩和缩短。当挠性结构由轴向力F压缩时，内结构和外结构的直径变得更大。由于聚合物基体是弹性体材料，它跟随挠性结构2的压缩或伸展。
当扭力F如图18中所示围绕杆状植入物的纵轴作用时，挠性结构2承受该扭力，使得实际上不会发生杆状植入物的扭曲。由于内结构和外结构相对于彼此旋转180°，可以提供高抗扭刚度。可以通过选择挠性结构的挠性性质特别地设计杆状植入物的抗扭刚度。
由于纤维的强度，也不会发生杆状植入物的纽结。
图19a-19c显示了杆状植入物的挠性结构的第二实施例。它与图1-18中所示的第一实施例的区别在于外结构具有与内结构相同的直径。内和外螺旋被连接成网络状或网状结构。
图20a和20b显示了挠性结构的进一步改进。挠性结构由单一内螺旋2a′和单一外螺旋2b′组成，所述外螺旋具有大于内螺旋的直径并且相对于内螺旋旋转180°。
可以预见进一步的改进。螺旋的绕组的节距可以在单一螺旋内或不同螺旋之间变化。挠性结构不一定由螺旋组成。它也可以是由纤维制造的另一个网络状或网状结构，例如带有钻石形开口的织物状结构，或者在提供旋转刚度的同时允许伸展和压缩的任何其它网络状或网状结构。
代替椎弓根螺钉可以使用任何其它骨锚固装置。

Claims (12)

1.用于脊柱的动态稳固的杆状植入物，所述杆状植入物的至少一部分包括形成基体(3)的挠性第一材料，包括由第二材料制造的至少一个纤维的挠性结构(2)嵌入所述基体(3)中，其特征在于，所述挠性结构(2)包括同轴网络状的内结构(2a)和围绕内结构布置的同轴网络状的外结构(2b)；所述内结构(2a)和外结构(2b)相对于彼此旋转180°。
2.根据权利要求1所述的杆状植入物，其中第一材料是聚合物。
3.根据权利要求1所述的杆状植入物，其中第一材料是弹性体材料。
4.根据权利要求1-3之一所述的杆状植入物，其中第二材料是合成材料。
5.根据权利要求1-3之一所述的杆状植入物，其中第二材料是聚丙烯。
6.根据权利要求1-3之一所述的杆状植入物，其中所述挠性结构(2)包括相对于彼此旋转一个角度的至少两个螺旋状纤维。
7.根据权利要求6所述的杆状植入物，其中所述角度为180°。
8.根据权利要求6所述的杆状植入物，其中所述螺旋状纤维具有相同的直径。
9.根据权利要求6所述的杆状植入物，其中所述同轴网络状的内结构(2a)和同轴网络状的外结构(2b)具有不同的直径。
10.根据权利要求1-3之一所述的杆状植入物，其中所述挠性结构(2)增强杆状植入物(1)的抗扭刚度。
11.根据权利要求1-3之一所述的杆状植入物，其中所述内结构(2a)包括四个螺旋(2a1，2a2，2a3，2a4)，并且所述外结构(2b)包括四个螺旋(2b1，2b2，2b3，2b4)。
12.根据权利要求11所述的杆状植入物，其中内结构的螺旋相对于彼此旋转90°，并且外结构的螺旋相对于彼此旋转90°。
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