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CN1985770A - 用于动态稳定骨或椎骨的柔性稳定装置 - Google Patents

用于动态稳定骨或椎骨的柔性稳定装置 Download PDF

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CN1985770A
CN1985770A CNA2006101659651A CN200610165965A CN1985770A CN 1985770 A CN1985770 A CN 1985770A CN A2006101659651 A CNA2006101659651 A CN A2006101659651A CN 200610165965 A CN200610165965 A CN 200610165965A CN 1985770 A CN1985770 A CN 1985770A
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sleeve pipe
stabilization device
flexible stabilization
bone anchoring
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卢茨·比德尔曼
威尔弗里德·马蒂斯
黑尔玛·拉普
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Biedermann Technologies GmbH and Co KG
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
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    • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
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    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
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    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • 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
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Abstract

一种用于动态稳定骨或椎骨的柔性稳定装置，包括杆构造(20)，该杆构造包括由弹性材料制成的杆(20)，所述杆具有第一连接段(20a)、第二连接段(20b)和位于所述第一连接段和第二连接段之间的第三段(20c)，第一和第二连接段(20a，20b)可分别与骨锚固装置连接；和套管(40)，其设置在杆的第三段(20c)的至少一部分上以便至少第一和第二连接段(20a，20b)是外露的。

Description

用于动态稳定骨或椎骨的柔性稳定装置
技术领域
本发明涉及一种用于动态稳定骨或椎骨的柔性稳定装置，该装置包括由弹性材料制成的杆状构造。
背景技术
从EP0669109B1已知一种用于稳定相邻椎骨的柔性稳定装置。在这个稳定装置中放置在邻近椎骨中的单轴骨螺钉由弹性带连接。以预应力的方式将该带紧固到骨螺钉。抵抗压力的支撑体在骨螺钉之间环绕该带以便传递压力。支撑体、骨螺钉的头部和弹性带形成一种允许椎骨有限运动的连接。
US2003/0220643A1公开了一种连接相邻椎体的装置，其中单轴肉茎螺钉通过弹簧互相连接。该弹簧允许脊椎弯曲和有限角度的横向弯曲以及轴向旋转同时防止脊椎伸展而无需横向部件。在弹簧上放置套管。在套管与肉茎螺钉之间的冲击帮助弹簧防止脊椎伸展。弹簧的长度是预先确定的。外科医生要在长度上进行适配是不可能的。
WO2004/105577A2公开了一种具有一个或多个具有螺旋形开口或缝隙的柔性元件的脊椎稳定系统。在外科手术中，系统关于其柔性的调节是不可能的。
从EP1364622A2中已知一种包括单轴骨螺钉和由弹性材料制成的柔性杆的骨锚固装置。骨锚固装置的弹性由杆的材料和形状决定，其不能由外科医生改变。而且，单轴螺钉的使用限制了轴相对杆的位置调整的可能性。
发明内容
本发明的目的是提供一种用于动态稳定骨或椎骨的柔性稳定装置，其允许在外科手术中改变装置的弹性，同时改变杆构造长度的适应性。
通过如权利要求1的骨锚固装置得以实现本发明的目的。在从属权利要求中给出了进一步的改进。
柔性杆构造包括由弹性材料制成的内杆和外杆或套管允许大范围调节稳定装置的弹性。通过选择杆和套管的适当弹性，其可以彼此不同，使杆构造的弹性与特定脊椎段的运动适配成为可能。特别地，可以通过内杆的弹性控制脊骨的柔性和压力，同时可以通过选择适当的套管来控制脊骨的伸展。相对于柔性/压力和伸展运动的阻尼分离导致在该构造的运动控制下椎骨段谐和的行为。因此防止了骨螺钉的松动。进一步的优点是能够调节内杆与套管的长度。因此，提供了一种允许在外科手术时进行适配的组件系统。与多轴螺钉结合进一步增加了调节的可能性。
附图说明
通过参照下面结合附图的对实施例的详细说明将会清楚及最佳地理解本发明的进一步特征和优点。
图1a示出了根据本发明实施例的杆构造的透视分解图。
图1b示出了图1a的杆构造处于组装后的状态。
图2示出了包括图1a的杆构造的稳定装置的分解图。
图3示意性地示出了图1a的杆容纳在多轴骨螺钉的接收部分内的分解图。
图4示出了图3的零件组装后的截面图。
图5示意性地示出了图2的稳定装置组装后施加到脊柱的相邻椎骨上。
图6a示意性地示出了脊柱处于弯曲状态时的图5的稳定装置。
图6b示意性地示出了脊柱处于伸展状态时的图5的稳定装置。
图7示意性地示出了图1b的杆构造的移动方向。
图8a示意性地示出了杆构造处于图6a所示的弯曲状态。
图8b示意性地示出了杆构造处于图6b所示的伸展状态。
图9a和9b示出了顶视的稳定装置进一步应用的范例。
图10示出了杆构造在截面的变形。
具体实施方式
如图1a和1b所示，柔性稳定装置包括杆构造，杆构造包括由弹性材料制成的杆20和也由弹性材料制成的套管40。在这个实施例中示出的杆20为具有平滑表面的圆柱形。由于弹性材料的原因，杆为部分或完全柔性。例如，杆20由例如基于聚氨酯、有机硅聚合物或PEEK的聚合物的生物兼容塑性材料制成。一种尤其适合的材料是聚碳酸酯聚氨酯。杆的材料包括定义明确的弹性并且杆表现出弯曲弹性、压力弹性和拉力弹性。
套管40的弹性材料也是例如基于聚氨酯、有机硅聚合物或PEEK的聚合物的生物兼容塑性材料，其包括不依赖于杆20的弹性而选择的弹性。同样对于套管来说聚碳酸酯聚氨酯是尤其适合的。套管40为包括通道41的管状形状，其直径略微大于杆20的外径以便能把杆插进通道41，如图1b所示。选择套管40的长度小于杆20的长度，以便在图1b所示的组装后的状态中，杆20的第一连接段20a和第二连接段20b从通道41伸出。杆20的第一连接段20a和第二连接段20b之间的段20c容纳在套管40的通道41内。优选地，套管的长度大致对应于骨锚固装置接收部之间的距离，或可能略微大一些。
参照图2-4，说明了杆20与骨锚固元件1的接收部6的连接。为了便于说明，图3省略了套管40。在把杆20固定到骨锚固元件1的各个接收部6之前将套管40放置在杆20上。
在这个实施例中，骨锚固元件1为具有柄2的多轴骨螺钉，在柄2的一端有骨螺纹、尖端3并且在相对一端有球形头部4。在头部4的与柄相对的一侧设置与螺纹拧紧工具接合的凹槽5。接收部6具有第一端部7和与第一端部相对的第二端部8，并且纵向轴线9与第一和第二端部的平面相交。与纵向轴线9同轴地设有孔10，其从第一端部7延伸到距第二端部8一个预定距离的位置。在第二端部8处设置一个开口11，其直径小于孔10的直径。邻近开口11设置球形或其他的锥形段12形成球形头部4的座。
接收部6进一步具有U形凹槽13，其起始于第一端部7并且沿第二端部8的方向延伸到距第二端部一个预定距离的位置。借助于U形凹槽13，形成向第一端部7延伸的两个自由腿14、15。接收部6在邻近第一端部7处在所述腿14、15上包括内螺纹16。
如图3中所见，设置第一压力元件17，其为外径仅略小于孔10的内径的圆柱构造，以便允许第一压力元件17插入接收部的孔10内并且在轴向移动。在其面对第二端部8的下侧，压力元件17包括球形凹槽18，凹槽18的半径对应于骨螺钉的球形头部4的半径。在相对的一侧，第一压力元件17具有圆柱形凹槽19，其横向于纵向轴线9延伸。所述凹槽的横向直径选择为使得待接收进接收部的杆20的各个具有圆形横截面的连接段20a或20b能插进凹槽19并在那里被横向地引导。圆柱形凹槽19的深度选择为使得在组装后的状态中，当杆20的连接段被插入并压靠U形凹槽13的底部时，第一压力元件17向头部5施加压力。又一深度优选地大约为杆20的连接段直径的一半。如图3中所见，第一压力元件17具有用于引导螺纹拧入工具穿过其中的同轴孔21。
如图3和4所示，骨锚固元件进一步包括具有第一端部24和第二端部25的第二压力元件23。第二压力元件的宽度是这样的，即第二压力元件能插入接收部6的U形凹槽13。在第二压力元件的相对侧上包括两个凸起26，其装配进内螺纹16限定的空间，以便当插入第二压力元件时沿内螺纹滑动。
如图2所见，第二压力元件23进一步包括从第二端部25向第一端部24的方向延伸的圆柱形凹槽27，其圆柱体轴与圆柱形凸起26垂直。在第二端部的侧面上圆柱形凸起26包括下边缘26a。圆柱形凹槽27的直径对应于杆20连接段的直径并且其深度为连接段直径的一半或小于其一半。
骨锚固元件进一步包括能被拧进腿14、15之间的内螺钉30。内螺纹16和内螺钉30的协同的螺纹可以是任意已知的螺纹形状。平螺纹或负角螺纹提供了防止腿14、15张开的优点。
接收部6和第一压力元件17可以在相对侧面上具有相应的压紧孔32、33，借助于其螺钉1，接收部6和第一压力元件17能够被松散地预组装。如图3和4所示，第一压力元件和第二压力元件23可以分别有凸起22、28，其可以用于固定弹性杆20。
除了杆和套管之外，柔性稳定装置的其他部分由通常使用的生物兼容材料，例如不锈钢或钛或任何其他的适于骨螺钉的材料制成。
在使用中，将至少两个骨锚固装置锚进骨中。接着，选择并组合杆20和套管40以便实现需要的柔性稳定装置的弹性。如果例如连接多于两个椎骨时，可以选择具有不同弹性的不同的套管40并设置在不同椎骨之间。通过这种方式，可以在外科手术时改变稳定装置的弹性。优选地，当肉茎螺钉拧入相邻的椎骨内时，套管的长度选择为对应于两个接收部的距离。由于杆20和套管40由弹性材料制成，在外科手术中进行缩短是可能的。然后，将带有套管40的杆20或者如果必须用单个杆稳定多于一个运动段时带有多个套管的杆20插入骨锚固元件的接收部6。优选地，在两个相邻椎骨的平衡位置，套管与接收部接触。
之后，将第二压力元件23插入接收部并且把内螺钉拧进腿之间。在调整骨螺钉的角位置之后，内螺钉30被紧固。通过将内螺钉30施加的压力施加到第二压力元件23之上，杆20被夹在第一与第二压力元件之间，同时骨螺钉的头部4被锁定在其角位置。
接着，参照图5至8b，描述了柔性稳定装置的弹性。在图5中，示出了组装后的稳定装置，其中杆20和套管40布置成连接两个放置在相邻椎骨W内的多轴肉茎螺钉形成运动段。肉茎螺钉的柄的位置用点划线表示。如图5中见到的，骨锚固元件1的接收部6在平衡位置具有距离x，在该位置杆20和套管40处于不受应力状态。
图6a示出了当发生弯曲时的稳定装置。在弯曲期间，拉应力施加到杆20导致杆的伸长。骨锚固元件之间的距离增加到x+Δx1。距离的增加量Δx1由杆20的弹性产生的回复力限制。距离的增加量可以在例如大约1.5mm范围内。因此，主要由内杆20控制弯曲/压缩。
图6b示出了当发生伸展时在伸展过程中的稳定装置，通过骨锚固元件1的接收部6将压缩力施加到杆20和套管40。杆20和套管40的弹性允许接收部6之间的距离减少到距离x-Δx2。由于杆20和套管40的弹性回复力作用到接收部6上，其限定了距离的减少量。距离可以例如减少大约0.5mm。因此伸展由内杆20的可压缩性控制并由套管限定。
在应用的可替换方式中，可以将套管预压缩在平衡状态和/或杆可被预加应力在平衡状态。
图7图示了杆20和套管40可能经受的变形。图8a和8b示出了杆20和套管40处于弯曲(图8a)和伸展(图8b)状态的变形。
图9a和9b示出了稳定装置应用的一个范例。图9a示出了出现脊柱侧凸的情况中两个相邻椎骨V、V’中间横向地相对彼此倾斜。为了动态地稳定并矫正这样的运动段，具有不同套管400、400’的杆200、200’可用在左侧和右侧上。用在左侧杆200上的套管400的长度大于用在右侧杆200’上的套管400’的长度。以这种方式，使得消除左侧两个椎骨的倾斜成为可能。另外，套管400的外径与套管400’的外径不同，以便相对左侧和右侧具有不同的运动控制。
上述实施例的进一步的变形也是可能的。在上述实施例中，套管40为中空圆柱体形状；但是，套管也可能是不同的形状。例如，桶形也是可以的。套管的长度可以不同于示出的实施例。杆20还可以具有矩形、正方形、椭圆形或三角形的横截面或任意其他适合的横截面形状。由此，套管40的形状可以适当地改变。特别地，在纵向上形成具有变化形状的杆和/或套管也是可以的。杆和套管可以形成为高度柔性或几乎不能弯曲的。
杆和/或套管的表面可以是有网纹(textured)或纹理(structure)的。图10示出了内杆20具有波纹表面的一个范例，波纹300设置在圆周方向上。套管401的内壁具有相应的与杆的波纹协同的波纹。这防止或减少了套管相对杆的移动。
在上述骨锚固元件的范例中，骨锚固元件1的柄2与各个接收部6的连接是多轴的。但是，提供单轴连接也是可以的。
对于内螺钉30来说，可以采用所有已知的变形。这还包括使用外环或螺母。
在描述的实施例中，把骨锚固元件从顶部插入接收部。但是，骨锚固元件也可以从接收部的底部插入，如果接收部构造成允许这样的话。
骨锚固元件的头部和柄可以构造为能连接在一起的单独部件。
本发明不局限于作为骨锚固元件的螺钉，还可以用作骨钩或任意其他的骨锚固元件。

Claims (9)

1、一种用于动态稳定骨或椎骨的柔性稳定装置，包括：
杆构造(20，40；200，400；201，401)，该杆构造包括：
由弹性材料制成的杆(20；200；201)，所述杆具有第一连接段(20a)、第二连接段(20b)和位于所述第一连接段和第二连接段之间的第三段(20c)，第一和第二连接段(20a，20b)可分别与骨锚固装置连接，和
套管(40；400；401)，其设置在杆的第三段(20c)的至少一部分上以便至少第一和第二连接段(20a，20b)是外露的。
2、根据权利要求1所述的柔性稳定装置，其中，套管(40；400；401)由弹性材料制成。
3、根据权利要求2所述的柔性稳定装置，其中，杆和套管的弹性是不同的。
4、根据权利要求1-3之一所述的柔性稳定装置，其中，弹性材料是生物兼容的塑性材料，例如聚氨酯或有机硅聚合物。
5、根据权利要求1-4之一所述的柔性稳定装置，其中，套管的内壁与杆表面接触。
6、根据权利要求1-5之一所述的柔性稳定装置，其中，套管(401)的内壁具有与杆(201)表面上的纹理接合的纹理(300)。
7、根据权利要求1-6之一所述的柔性稳定装置，进一步包括与杆构造连接的至少一个第一和第二骨锚固装置(1)。
8、根据权利要求7所述的柔性稳定装置，其中，至少一个骨锚固装置构造为允许在其柄(2)和杆(20)之间的多轴连接。
9、根据权利要求1-8之一所述的柔性稳定装置，其中，杆包括多个连接段和位于所述多个连接段之间的多个套管。
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EP1800613B1 (en) 2008-07-16
KR101279085B1 (ko) 2013-06-26
US20140031868A1 (en) 2014-01-30
EP1800613A1 (en) 2007-06-27
TW200726429A (en) 2007-07-16
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TWI432171B (zh) 2014-04-01
ES2309646T3 (es) 2008-12-16
US8157843B2 (en) 2012-04-17
KR20070066877A (ko) 2007-06-27

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