CN103917181A - 包括套接杆和具有低外形边缘锁的摩擦配合保持件的多轴骨锚 - Google Patents

包括套接杆和具有低外形边缘锁的摩擦配合保持件的多轴骨锚 Download PDF

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CN103917181A
CN103917181A CN201280054722.4A CN201280054722A CN103917181A CN 103917181 A CN103917181 A CN 103917181A CN 201280054722 A CN201280054722 A CN 201280054722A CN 103917181 A CN103917181 A CN 103917181A
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罗杰.P.杰克逊
J.L.苏伯
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Abstract

一种多轴骨螺钉组件,包括螺纹杆本体,其具有可接收在一体接收件中的一体上部分,该接收件具有上通道用于接收长形连接构件和与下开口共同操作的下腔体。可向下载入压缩插件,具有内和外柄脚的可向下载入摩擦配合切口保持环以及可向上载入杆上部分相配合,以在将杆植入脊椎之前或之后提供杆与接收件的套接或卡接组件。该杆和接收件一旦被装配则不能拆开。

Description

包括套接杆和具有低外形边缘锁的摩擦配合保持件的多轴骨锚
技术领域
本发明涉及用于骨外科手术中的多轴(polyaxial)骨螺钉,具体地用于脊椎外科手术和具体地涉及螺钉,其具有压缩或压力插件以及扩展锁定裂口保持件(split retainer)以将骨螺钉杆头部卡住、稳固和保持在接收件构件组件中并稍后将骨螺钉杆相对于接收件组件固定。
背景技术
骨螺钉用于多种类型的脊椎外科手术中,用于将多种植入件沿着脊柱固定至脊椎,用于稳定和/或调节脊椎排列(alignment)的目的。尽管已知闭合端和开口端骨螺钉,然而开口端螺钉特别地适合连接至柱和连接件臂,由于该柱或臂不需要穿过封闭的孔,而是可被置于或推动进入接收件或该螺钉的头部中的开口通道中。总体而言,螺钉必须与头部作为整体单元而插入骨中,或者作为杆和枢转接收件的形式的预装配单元,例如多轴骨螺钉组件。
常规的开口端骨螺钉包括带螺纹的杆,其具有一对平行的突出分支或臂,形成具有U型槽或通道的轭(yoke)用于接收杆。用于脊椎固定技术的钩和其它类型的连接件还可包括类似的开口端,用于接收其它固定和稳定结构的杆或部分。
用于提供脊柱支撑的常规方式是将骨螺钉植入特定骨中,其然后进而支撑诸如杆的纵向结构,或者由该杆支撑。该类型的骨螺钉可具有相对于其杆的固定头部或接收件,或者可以是多轴螺钉特征。在固定骨螺钉中,杆接收件头部不能相对于杆移动,且杆必须被有利地定位以让其被设置在接收件头部中。这有时是很难或不可能的。因此,通常优选多轴骨螺钉。在杆或其它纵向连接构件插入接收件中,接着是锁定螺钉或其它封闭件时,开口端多轴骨螺钉通常允许头部或接收件关于杆的松散或宽松的旋转,直到实现接收件的要求的旋转位置,通过在医疗手术的最后阶段相对于杆固定该位置而实现接收件的期望的旋转位置。在一些情况下,该宽松特征可以是不合乎要求的,且使得手术更加困难。此外,由于接收件或头部的体积可挡住外科医生,所以通常期望将骨螺钉杆与接收件或头部分离地插入。允许该功能的螺钉有时被称作模块化多轴螺钉。
具体参考具有杆接收组件的模块卡接或套接多轴椎弓根螺钉系统,该现有技术示出并说明了接收件和一些保持件形成组件的概念,其中在部件之间形成可收缩的锁定接合,以将杆头部关于接收件和保持件固定。由于保持件和/或套爪(collet)结构与接收件之间的直接接触使得带槽保持件环和/或插件的套爪类型结构收缩靠在杆头部上,现有技术的接收件和杆头部保持组件包括带槽的可收缩保持件环和/或下压力带槽插件,其具有用于杆头部的具有可收缩锁定接合的扩展和收缩套爪类型结构。该接收件和带槽插件大体包括锥形锁定接合表面。
还示出并公开了现有技术的模块化多轴螺钉组件,在带槽套爪和/或保持件的外侧与接收件的内侧上的接触表面,除了是锥形的以外,还可以是圆椎形、圆弧形、球形、弯曲的、多弯曲、圆角形,以及其它配置,以形成杆头部关于接收件的可收缩类型锁定接合。
此外,示出并公开了现有技术的模块化多轴螺钉组件,其中当插件或保持件处于上位置且位于接收件的扩展凹部或腔室内时,杆头部可进入和离开插件上的套爪类型结构或者保持件。这即是这种情况,除非带槽的插件和/或带槽的保持件被阻挡或限制防止其能被推动或操作向后向上进入接收件孔或腔体中,或者除非螺钉组件被另外独特地配置成防止该情况发生。
发明内容
本发明与现有技术的区别在于一旦部件被卡接和连接,则不允许接收件从杆头部移除。即使保持件可向上返回至扩大腔室,也是这种情况。与现有技术的模块化多轴螺钉设计相比,已发现该方法和设计更加安全(secure)且可对拉出力提供更大阻力。如现有技术中所示,已发现当用于模块化多轴螺钉设计时,套爪类型结构从下压力插件向下延伸在一些程度上相对于在一些脊椎复位过程(spinal reduction procedures)中所经历的拉出力是比较弱的。本发明被设计以解决该问题。
本发明与现有技术的区别还在于提供了切口(split)保持件环,其具有部分地弧形的内摩擦配合表面,内摩擦配合表面不参与杆头部相对于接收件的最终锁定接合。此外,用于本发明的保持件环本身的独特特征在于底座部分提供了扩张以接收和捕获杆头部,且接着具有在杆头部和保持件环底座之间以及在保持件环底座和接收件的底部开口附近的水平和竖直加载表面之间的扩张(不收缩)锁定接合。
本发明的该仅扩张保持件环底座部分被完全地设置在接收件中杆头部半球下方,且可以是更加坚固,更加结实的结构以抵抗作用在组件上的较大的拉出力。该保持件环底座还可在接收件的底部中的下开口附近处被更好地支撑在大体水平加载表面上。已发现与现有技术中如上所述在部件之间使用一些类型的可收缩锁定接合相比,该设计更加坚固和更加牢固;并且一旦被装配则不能被拆开。
因此,根据本发明的多轴骨螺钉组件包括杆,其具有一体上部分或一体弧形或球形头部以及用于固定至骨的本体;单独的接收件,其限定上开口通道、中间孔、下腔体和下开口;顶部下降和旋转到位(top drop and turn inplace)的下压缩插件;摩擦配合弹性扩张的锁定裂口保持件,用于将杆头部捕获在接收件下腔体中,在将杆锁至期望配置之前,杆头部与摩擦配合保持件和接收件摩擦地接合但仍可以非宽松的方式移动。如上文所述,由于通过封闭顶部按压在捕获在接收件孔和通道中的杆上的或者其它纵向连接构件而作用在压缩插件上的向下力,通过插件和保持件的下裂口环状部分之间的摩擦接合使得该杆相对于接收件最终锁定至固定位置。在所示的实施方式中,保持件和压缩插件被向下载入接收件中,但还可预见向上载入的实施方式。可在将杆插入骨之前或之后将杆头部设置在接收件下腔体中在其下开口处。在一些实施方式中,压缩插件包括锁定和释放特征,用于将多轴机构独立地锁定,从而螺钉可作为固定的单轴(monoaxial)螺钉使用。此外,在一些实施方式中,本组件的杆和其它元件可中空以用于最少侵入式外科手术应用。该保持件包括向上延伸的柄脚,其在接收件腔体中展开,从而保持件和被捕获的杆头部被稳固的且被保持在接收件锁定腔室中,但是可在腔体中自由旋转。这样,杆头部和保持件可被部分地限制且无法向上返回至接收件腔体,但可在其中被操作。
此外,在将杆植入脊椎之前或之后,将预组装的接收件,压缩插件和摩擦配合裂口保持件“推至”、“卡接”或“套接”至杆头部。该“卡接”处理包括以下步骤,将杆头部向上载入至接收件下开口中,将杆头部压靠在裂口保持件环的底座部分上,和使弹性下开口保持件部分扩张进入接收件腔体的扩展部分或腔室中,随后在杆头部的半球或上部分通过保持件的下环形部分之后,该保持件弹性地返回至标称或接近标称形状。该杆头部进入与保持件的一些部分的摩擦配合接合,该保持件的这些部分至少部分地由保持件的内柄脚限定。随着保持件返回至中性或接近中性方向,保持件卡接至杆头部上,在保持件和杆头部之间提供非宽松连接。在所示的实施方式中,当杆被最终地锁定在压缩插件和保持件的下部分之间时,下保持件边缘表面锁靠杆头部。由于杆头部与切口保持件的下边缘部分之间的锁定扩张类型接触以及保持件环的下部分与接收件腔体的下部分中的锁定腔室之间的扩张类型非锥形锁定接合,形成该最终固定。该保持件可在接收件腔体的上部分或扩展腔室中更多地扩张,以允许杆头部通过,但是在最后锁定过程中,在保持件下环部分抵靠在接收件腔体的下部分中的锁定腔室上,并且杆头部被向下推靠在保持件环上时,保持件受限扩张以保持杆头部。在一些实施方式中,当多轴机构被锁定时,压力或压缩插件被推动或楔靠在接收件的表面上,导致干涉锁定接合,允许调节或移除柱或其它连接构件,且没有损失杆与接收件之间的期望角度关系。该独立锁定特征允许多轴螺钉用作固定单轴螺钉。
下压力插件还可被配置成通过工具或器具独立地锁定,从而允许套接多轴螺钉被沿着和围绕柱而分离(distracted)、压缩和/或旋转,以提供改进的脊椎矫正技术。该工具从侧面接合接收件,且接着接合插件的向外延伸的带翼臂,以将插件向下推动或楔入接收件中的锁定位置。随着工具仍然在该位置且保持矫正,接着可通过封闭顶部而将柱锁定在接收件通道中,随后移除工具。该处理可包括通过多个工具同时地操作多个螺钉,以实现要求的矫正。
本发明的目的是还包括提供设备和方法,其易于使用且特别适于其所要实现的使用,且其中工具的制造是相对便宜的。参考作为本发明的一些实施方式的示出和示例的附图根据以下说明,本发明的其它目的和优点将是明显的。
附图构成本说明书的一部分,且包括本发明的示例性实施方式,并示出了其多种目的和特征。
附图说明
图1是根据本发明的多轴骨螺钉组件的分解透视图,包括杆、接收件、开口摩擦配合保持件、和顶部下降和旋转到位的下压缩插件,还示出了柱形式的长形连接构件和封闭顶部的一部分。
图2是图1的杆的放大顶视图。
图3是沿着图2的线3-3截取的缩小横剖视图。
图4是图1的接收件的放大侧视图。
图5是图4的接收件的透视图。
图6是图4的接收件的正视图。
图7是图4的接收件的底视图。
图8是图4的接收件的顶视图。
图9是沿着图8的线9-9截取的横剖视图。
图10是沿着图8的线10-10截取的横剖视图。
图11是图1的保持件的放大透视图。
图12是图11的保持件的正视图。
图13是图11的保持件的顶视图。
图14是图11的保持件的底视图。
图15是沿着图13的线15-15截取的放大横剖视图。
图16是图11的保持件的另一个透视图。
图17是图1的插件的放大透视图。
图18是图17的插件的侧视图。
图19是图17的插件的另一个透视图。
图20是图17的插件的顶视图。
图21是图17的插件的底视图。
图22是沿着图20的线22-22截取的放大横剖视图。
图23是沿着图20的线23-23截取的放大横剖视图。
图24是图1的保持件和接收件的放大正视图,其中接收件的部分被切开以示出其细节,示出该保持件被载入接收件(以虚线示出)中至装配的部分插入阶段。
图25是保持件和接收件的正视图,其中部分被切开,与图24中所示相似,示出了保持件处于装配的后继阶段,且处于最大的压缩状态。
图26是图25的接收件和保持件的底视图。
图27是保持件和接收件的放大正视图,其中部分被切开,与图25中所示相似,示出了保持件被设置在接收件弹簧凸片下方,且还关于其中心轴线转动,该转动在装配中不必须,但在此提供以帮助观察视图。
图28是沿着图27的线28-28截取的横剖视图。
图29是保持件和接收件的放大正视图,其中部分被切开,与图27中所示相似,中示出的保持件处于接收件中稍稍下方的位置且还包括在侧视图中虚线示出的、向下载入接收件中的插件,并且当处于在接收件中适于旋转的位置时的该插件(实线示出其中部分被切开)。
图30是保持件和接收件的正视图,其中部分被切开,与图29中所示相似,还示出了插件在接收件中部分地旋转,其中在该旋转过程中接收件弹簧凸片被向外推。
图31是具有部分被切开的缩小的正视图,与图30相似,示出的插件在接收件中完全旋转,其中接收件弹簧凸片被压入插件的孔中,且保持件弹簧凸片被设置成弹性地向外推靠接收件,在运输和与图1的杆装配的过程中,将保持件保持靠在接收件上并将保持件保持在向上位置,还示出了图1中的杆的放大和部分正视图,并将其植入脊椎的部分中,杆头部的半球和脊椎部分都以虚线示出。
图32是放大和部分正视图,其中部分被切开,与图31相似,还示出杆处于与接收件和保持件的第一装配阶段。
图33是放大和部分正视图,其中部分被切开,与图32相似,示出了围绕杆头部的中间部分处于扩张状态的保持件下部分。
图34是缩小的和部分正视图,其中部分被切开,与图33相似,示出该球形杆上部分或头部被完全由保持件捕获。
图35是缩小的和部分正视图,其中部分被切开,与图34相似,示出了具有连接的保持件的杆上部分被向下拉入下接收件腔体中的座位置,该保持件弹簧凸片处于基本中性位置,向外延伸并被捕获在接收件的表面下方。
图36是放大和部分正视图,其中部分被切开,与图35相似,示出了该插件通过图1的柱和封闭顶部从上方施加在其上的压力而被向下推入下接收件腔体中的完全坐靠位置,还以部分正视图示出,该插件被设置成与接收件锁定干涉配合。
图37是图36的锁定组件的部分透视图,其中部分被剖开以示出其细节。
图38是放大和部分正视图,其中部分被切开,与图36相似,但锁定插件通过工具(未示出)被稍稍向上拉,以得到解锁的多轴机构。
图39是放大和部分正视图,其中部分被切开,与图36相似,但其中图1的柱和封闭顶部被移除,该锁定插件将杆锁定到位,该图还示出了安装在接收件中的可选的可变形柱和配合封闭顶部。
图40是缩小和部分正视图,其中部分被剖开,与图39相似,示出了固定至接收件的可选的柱和封闭顶部。
图41是图1的组件的缩小的侧视图,示出了与杆的完全装配,该杆相对于接收件成二十二度(向头部地)角度。
图42是图41的组件的放大和部分侧视图,其中部分被切开以示出其细节。
图43是图1的组件的缩小的侧视图,示出了与杆的完全装配,该杆相对于接收件成三十三度(向尾部地)角度。
图44是图43的组件的透视图。
图45是图43的组件的放大和部分侧视图,其中部分被切开以示出其细节。
图46是根据本发明的可选的有利角度接收件的放大透视图,其具有相对的下凹进阶梯表面,用于与图1的保持件配合,以允许图1的杆相对于可选的接收件的最大四十度角度。
图47是根据本发明的用于替代图1的锁定插件的可选的非锁定插件的放大透视图。
图48是图47的可选的插件的另一个放大透视图,其中部分被切开以示出其细节。
图49是图47的可选插件的侧视图,其中部分被切开以示出其细节。
图50是图1的接收件和保持件的放大正视图,示出了其处于与图47的可选插件装配的阶段,也在正视图中,部分被切开以示出其细节。
图51是图1的接收件、保持件、柱和封闭顶部与图47的可选插件完全装配的放大和部分正视图,也在正视图中,部分被切开以示出其细节。
图52是根据本发明的套管的透视图,该套管用于本发明的骨螺钉组件。
图53是图52的套管的正视图。
图54是图52的套管的顶视图。
图55是图52的套管的底视图。
图56是图52的套管的侧视图,其中部分被切开以示出其细节。
图57是图52的套管的缩小的透视图,示出了其与图1(部分地分解显示)的骨螺钉装配,其中图1的柱由绳替代,且还示出了围绕绳在套管的每一侧设置的一对透明可压缩圆柱间隔器。
图58是沿着图57的线58-58截取的放大横剖视图,其中示出了与接收件配合的封闭顶部。
图59是沿着图58的线59-59截取的缩小的横剖视图。
图60是图52的套管和图1的骨螺钉组件的部分分解正视图,但是图1的柱和封闭顶部由绳和可选的绳锁定封闭顶部替换。
图61是正视图,与图60相似,其中部分被切开以示出其细节,示出了可选的绳锁定封闭顶部与套管和接收件接合。
图62是图57中所示的组件的放大和部分透视图,但是其中一个间隔器被缓冲器(示出为透明的)和阻断器/固定螺钉组合替换,所示部分地分解。
图63是图62的组件的放大和部分侧视图,其中部分被切开以示出其细节,示出了固定螺钉将绳相对于阻断器固定且绳与骨螺钉成滑动关系。
图64是图1的组件的放大透视图,但是图1的柱和封闭顶部由本发明的具有矩形面的第二可选套管、绳和可选的绳锁定封闭顶部替换。
图65是图64的组件的部分和部分分解正视图。
图66是图64的组件的放大和部分正视图,其中部分被切开以示出其细节。
图67是图64的可选套管的顶视图。
图68是图67的可选套管的顶视图。
图69是图67的可选套管的底视图。
图70是图67的可选套管的侧视图,其中部分被切开以示出其细节。
图71是图64的组件的缩小透视图,还示出了椭圆形的可选可压缩间隔器(示出为透明的)。
图72是图71的组件的部分侧视图,还示出了椭圆形的第二可选可压缩间隔器(也示出为透明的)。
图73是图71中所示的椭圆形的可压缩间隔器的放大正视图。
图74是图73的间隔器的顶视图。
图75是根据本发明的可选多轴骨螺钉组件的展开透视图,包括杆、接收件、开口摩擦配合保持件和顶部下降和旋转到位的下压缩插件,还示出了柱形式的长形连接构件和封闭顶部的一部分。
图76是图75的接收件的放大侧视图。
图77是图76的接收件的放大侧视图。
图78是沿着图76的线78-78截取的横剖视图。
图79是沿着图77的线79-79截取的放大横剖视图。
图80是图75的保持件的放大正视图。
图81是图80的保持件的放大和部分正视图。
图82是图80的保持件的透视图。
图83是图80的保持件的另一个透视图。
图84是图80的保持件的顶视图。
图85是图80的保持件的底视图。
图86是沿着图84的线86-86截取的放大横剖视图。
图87是图75的插件的放大透视图。
图88是图87的插件的侧视图,其中部分被切开以示出其细节。
图89是图87的插件的正视图,其中部分被切开以示出其细节。
图90是图75的保持件和接收件的放大正视图,其中接收件的部分被切开以示出其细节,示出该保持件被向下载入接收件中至装配的部分插入阶段。
图91是保持件和接收件的透视图,其中部分被切开,与图90中所示相似,示出了保持件在后继的装配阶段以及在最大的压缩状态。
图92是保持件和接收件的正视图,其中部分被切开,与图91中所示的相似,示出了保持件被设置在接收件弹簧凸片下方,且还关于其中心轴线旋转,该旋转对于装配不是必须的但在这里提供以帮助观察视图。
图93是保持件和接收件的放大正视图,其中部分被切开,与图27中所示的相似,示出了保持件在接收件腔体中完全展开,且还包括侧视的插件,被向下载入接收件中,且位于适合在接收件中旋转的位置。
图94是保持件和接收件的正视图,其中部分被切开,与图93中所示的相似,还示出了插件在接收件中旋转至期望位置,其中接收件弹簧凸片被按压至插件的孔中,且还示出了保持件柄脚被挤压(未示出工具)以准备用于将保持件向上朝向插件移动。
图95是保持件和接收件的正视图,其中部分被切开,与图94中所示的相似,示出了在运输和与图75的杆装配的过程中,保持件所处的一位置,其中柄脚弹性地向外推靠接收件,将保持件保持靠在接收件上,并将保持件保持在向上位置,该图还示出了图75的杆处于早期装配阶段的放大和部分正视图,其中保持件、杆头部的半球以虚线示出。
图96是放大和部分正视图,其中部分被切开,与图95相似,示出了围绕杆头部的中间部分处于扩张状态的保持件下部分。
图97是放大和部分正视图,其中部分被切开,与图96相似,示出了该球形杆上部分或头部被保持件完全捕获。
图98是缩小和部分正视图,其中部分被切开,与图97相似,示出了具有连接的保持件的杆上部分被向下拉入在下接收件腔体中的坐靠位置,该保持件柄脚处于基本中性状态,向外延伸并被捕获在接收件的表面下方。
图99是缩小和部分正视图,其中部分被切开,与图98相似,示出该插件通过从上方由图75的柱和封闭顶部施加在其上的压力从而被向下推入在下接收件腔体中的完全坐靠位置,还示出了部分正视图,该插件被设置成与接收件锁定干涉配合。
图100是组件的放大和部分正视图,其中部分被切开,如图99中所示。
图101是图75的组件的放大和部分透视图,示出了与杆的完全装配,该杆相对于接收件成二十度(向头部地)角度设置。
图102是图75的组件的放大和部分透视图,示出了与杆的完全装配,该杆相对于接收件成三十度(向尾部地)角度设置。
图103是根据本发明的可选有利角度接收件的放大透视图,其具有相反的下凹进阶梯表面,其被示为与图75的保持件配合。
图104是根据本发明的用于替代图75所示的锁定插件的可选非锁定插件的放大透视图。
图105是图104的可选插件的放大正视图,示出了其处于与图75的接收件和保持件的装配阶段,其中部分被切开以示出其细节。
图106是图75的接收件、保持件、柱和封闭顶部的放大和部分正视图,示出其被完全装配至图104的可选插件,还在正视图中,部分被切开以示出其细节。
图107是根据本发明的另一个可选多轴骨螺钉的展开透视图,其包括杆、接收件、开口摩擦配合保持件和顶部下降和旋转到位的下压缩插件,还示出了柱形式的长形连接构件和封闭顶部的的一部分。
图108是图107的杆的放大和部分正视图。
图109是图107的接收件的放大正视图,其中部分被切开以示出其细节。
图110是图109的接收件的侧视图,其中部分被切开以示出其细节。
图111是图109的接收件的放大部分正视图。
图112是图107的保持件的放大透视图。
图113是图112的保持件的顶视图。
图114是图112的保持件的缩小底视图。
图115是沿着图113的线115-115截取的缩小的横剖视图。
图116是沿着图113的线116-116截取的横剖视图。
图117是图107的插件的放大正视图,其中部分被切开以示出其细节。
图118是图117的插件的侧视图,其中部分被切开以示出其细节。
图119是图107的保持件和接收件的放大正视图,其中接收件的部分被切开以示出其细节,示出该保持件被向下载入接收件中至部分插入的装配阶段。
图120是保持件和接收件的透视图,其中部分被切开,与图119中所示相似,示出了保持件处于后继的装配阶段段和最大压缩状态。
图121是保持件和接收件的正视图,其中部分被切开,与图119中所示相似,示出了保持件柄脚在接收件腔体中完全展开,但是保持件没有完全坐靠在接收件腔体中。
图122是图121中所示的组件的放大和部分正视图。
图123是保持件和接收件的正视图,其中部分被切开,与图121相似,且还包括侧视的插件,其被载入至接收件中处于适合在接收件中旋转的位置。
图124是保持件和接收件的缩小的正视图,其中部分被切开,与图123中所示相似,还示出了插件位于接收件中的期望的位置,其中接收件弹簧凸片被压入插件的孔中,且还示出图107的杆处于与保持件的早期装配阶段的放大和部分正视图。
图125是放大和部分正视图,其中部分被切开,与图124相似,示出了保持件下部分处于围绕杆头部的中间部分的扩张状态。
图126是放大和部分正视图,其中部分被切开,与图125相似,示出了该球形杆上部分或头部被保持件完全捕获,且示出杆头部被压靠在插件上。
图127是缩小和部分正视图,其中部分被切开,与图126相似,示出该杆上部分被部分地向下拉入接收件腔体中,该保持件外柄脚处于基本中性状态,且内柄脚接触杆头部上的脊。
图128是放大和部分正视图,其中部分被切开,与图127相似,示出了杆头部相对于内保持件柄脚被进一步向下拉。
图129是放大和部分正视图,其中部分被切开,与图128相似,示出了杆头部和所连接的保持件的继续向下拉,该保持件被向下拉至在接收件腔体中的坐靠位置。
图130是缩小和部分正视图,其中部分被切开,与图129相似,插件通过来自上方的由图107的柱和封闭顶部施加在其上的压力而被向下推至下接收件腔体中的完全坐靠位置,还在部分正视图示出了插件被设置成与接收件成锁定干涉配合。
图131是图130的组件的放大和部分正视图,其中部分被切开,但是封闭顶部松开且柱升起,然而该插件保持锁靠在接收件上,将保持件和杆维持在锁定位置。
图132是图131的缩小和部分正视图,其中部分被切开,但是柱和封闭顶部被移除并由可选的可变形柱和与之配合的可选的封闭顶部替换。
图133是图107的组件的放大和部分透视图,示出了与杆的完全装配,该杆相对于接收件处于二十度(向头部地)角度。
图134是图107的组件的放大和部分透视图,示出了与杆的完全装配,该杆相对于接收件处于三十度(向尾部地)角度。
图135是根据本发明的可选的非锁定插件的放大透视图,用于替换图107中所示的锁定插件。
图136是图135的可选插件的放大正视图,示出了与图107的接收件和保持件的装配阶段,其中部分被切开以示出其细节。
图137是图107的接收件、保持件、柱和封闭顶部的放大和部分正视图,示出了与图135的可选插件的完全装配,该插件也示出为正视图,其中部分被切开以显示其细节。
具体实施方式
如所要求的,这里公开了本发明的具体实施方式;然而,应理解所公开的实施方式仅仅是本发明的示例,其可实施为多种形式。因此,这里所公开的具体结构和功能细节不应理解为限制性的,但仅作为权利要求的基础和作为教导本领域技术人员将本发明应用至任何合适的具体结构的代表性基础。应注意,在本申请中涉及的任何词语顶、底、上和下等指在不同的附图中所示的定位,以及应用至该装置的通常含义,且不旨在限制骨连接结构在实际使用中的定位。
参考图1-38和41-46,附图标记1大体表示根据本发明的多轴骨螺钉装置或者组件。组件1包括:杆(shaft)4,杆4还包括与向上延伸的上部或头8一体形成的本体6;接收件10;摩擦配合保持件12;和皇冠形压缩或压力插件14。该接收件10、保持件12和压缩插件14被初始地组装,且还可在将杆本体6植入至脊椎17之前或之后与杆4组装,如下文中将更详细地说明的。图1和36-37还示出了一封闭结构(closure structure)18,用于捕获(capture)纵向连接构件,例如,进而接合压缩插件14的柱(rod)21,该压缩插件14将杆头8压靠至与保持件12固定地摩擦接触,从而将纵向连接构件21捕获并固定在接收件10中,并因此将构件21相对于脊椎17固定。该接收件10和杆4配合的方式使得接收件10和杆4可相对于彼此被固定在多个角度、铰接位置或者旋转对准位置中的任何一个,并且在从左至右和从前至后的选定角度范围内,以使得接收件10能与杆4活动或铰接接合直到在植入手术接近结束时该二者被彼此锁定或固定。该所示的柱21是硬的、刚性的、没有弹性且圆柱形的,具有外圆柱表面22。在一些实施方式中,该柱21可以是弹性的、可变形的和/或不同材料以及横剖面几何形状的(如参见图39和40)。可预见在其它实施方式中(未示出),该封闭顶部可使柱变形并将其直接压在插件14上。
最佳地如图1-3中所示的杆4是长形的,其具有带有螺旋缠绕骨可植入螺纹24(单或双导程螺纹形式和不同的螺纹类型)的杆本体6,该螺纹24从接近于上部或头部8的颈部26附近处延伸至本体6的末端28并从其径向向外延伸。在使用过程中,使用螺纹24来抓握并前进的本体6以末端28引导而植入脊椎17,并且通过安装或驱动工具(未示出)而向下驱动进入脊椎中,从而在位于或接近于颈部26的位置处被植入脊椎中,例如,如图31中所示,且在下文中更具体地说明。杆4具有大体以附图标记A所标识的旋转长轴线。
颈部26从杆本体6轴向地向上延伸。该颈部26可以是与本体6上螺纹24终止处的相邻上端或顶部32相比相同的半径或者通常是稍减小的半径。从颈部26轴向和向外继续延伸的是颈上部分或头部8,其提供设置成距上端32一距离的连接或捕获装置,且因此当本体6被植入脊椎时其距该脊椎17一距离。
在将杆4相对于接收件10固定在期望位置中之前,该杆上部分8被配置成用于在杆4与保持件12和接收件10之间的可枢转连接。杆上部分8具有外、凸起和基本球形表面34,其从颈部26向外和向上延伸,在一些实施方式中终止于基本圆形或多边形边缘或突缘38。在所示的实施方式中,截头圆锥表面39从球形表面34向内延伸至顶边缘38,在杆相对于接收件10和插件14的枢转过程中提供额外的间隙。该球形表面34具有外半径,其被配置成与保持件12的一个或多个边缘和/或表面暂时摩擦地、非宽松地(nan-floppy)、滑动地配合,以及与保持件12在其下内边缘的最终摩擦接合,以及与插件14在其内部分球表面和/或阶梯或脊形的表面的最终摩擦接合,如在以下段落中将更具体地说明。在图1以及其它一些附图中,虚线40表示球形表面34的半球。在本实施方式中示出的球形表面34是基本光滑的,但是在一些实施方式中可包括粗糙或者其它表面处理,且被尺寸设置和成型为用于与压缩插件14配合和最终摩擦接合,以及与保持件12的下环形边缘最终摩擦接合。该杆球形表面34通过插件14和保持件12下边缘部分被单独地(exclusively)锁定到位,而不是通过限定接收件腔体的内表面。
沉头或阶梯或渐进(graduated)环形座表面或底座45部分地限定内驱动零件(feature)或特征(imprint)46的一部分。在本发明的一些实施方式中,表面45是基本平坦的。所示的内驱动特征46是形成在顶部38中的孔并且具有六角形状,其被设计成将艾伦扳手(Allen wrench)类型的工具(未示出)接收至所述孔中用于将骨螺钉杆4旋转并驱动进入脊椎17中。可预见该内工具接合结构可采取多种工具接合形式且可包括多种形状的一个或多个孔,例如一对间隔开的孔或者多小叶(multi-lobular)或者星形孔。驱动特征46的渐进的座或底表面45被设置成基本垂直于轴线A,其中驱动特征46另外地与轴线A共轴。如图2和3中所示,具有倾斜的或阶梯的表面的驱动座45进一步促进通过驱动工具而抓握。在工作中,驱动工具(未示出)被接收在内驱动特征46中,位于底座45并与驱动特征46的面接合,用于在杆4通过保持件12连接至接收件10之前或之后将杆本体6驱动和旋转进入脊椎17,当杆4、保持件12和接收件10组合被驱动进入脊椎17中时驱动工具延伸进入接收件10。
在附图中所示的杆4是中空(cannulated)的,具有沿着轴线A在杆4的整个长度上延伸的小的中心孔50。孔50由杆4的内圆柱壁限定,且具有在杆末端28处的圆形开口,以及具有在驱动座45处与外驱动部46连通的上圆形开口。该孔50与螺纹本体6和上部分或头部8共轴。孔50提供穿过杆4内部的通道,以让一长度的线(未示出)通过该通道,该线在将杆本体6插入之前插入脊椎17,该线提供用于将杆本体6插入脊椎17的引导。可预见杆可以是实心的且由不同的材料制成,包括金属或非金属。
为了提供与骨连接的生物活性接合面,螺纹杆本体6可被涂层、穿孔、制成多孔或者另外地处理。该处理可包括但不限于等离子喷涂或者其它类型的金属涂层,或者例如磷酸钙;或者在杆表面粗化加工、穿孔或刻痕,例如通过溅射、喷砂或者酸蚀刻,其允许骨长入(bony ingrowth)或在其上生长(ongrowth)。一些金属涂层用作骨长入的台架。生物陶瓷磷酸钙涂层包括但不限于:α磷酸三钙和β磷酸三钙(Ca3(PO4)2,磷酸四钙(Ca4P2O9),无定形磷酸钙和羟基磷灰石(Ca10(PO4)6(OH)2)。例如,由于羟磷灰石在矿物含量方面与骨骼的化学成份相似,且被认为具有生物活性,因此不仅支持骨长入还积极地参加骨结合,所以具有羟磷灰石的涂层是有利的。
具体地参考图1和4-10,该接收件10具有大体U形的外观,且具有局部不连续的圆柱形内和外轮廓以及平坦的和其它弯曲表面。该接收件10具有旋转轴线B,其在图1中被示出为与杆4的旋转轴线A对齐并相同,这样方向是期望的,但在接收件10与杆4的装配过程中不需要如此。在接收件10可枢转地连接至杆4之后,在将杆4植入脊椎17之前或之后,轴线B通常被设置成相对于轴线A成一角度,例如如图41-46中所示。
接收件10包括底座60,其具有多个弯曲的和主要圆柱形的表面58以及相反的外平坦表面59,该底座60限定孔或内腔体,其大体以61指示,底座60与一对相对竖直臂62一体形成。在底座60处,平坦表面59被设置在臂62之间,且插入(inset)表面部分63被设置在各平坦表面59上方且与其相邻,各插入表面部分63横跨该对臂62之间。该臂62形成托架(cradle)并在臂62之间限定具有上开口的U形通道64,该上开口大体以66指示,以及限定U形下通道部分或座68,该通道64具有的宽度用于在臂62之间可操作地贴合地(snugly)接收柱21或者另一个纵向连接件或套筒(如图52-74中所示的)的一部分,该通道64与底座腔体61连通。内相对的基本平坦臂表面69部分地限定在弯曲座68上方的通道64,且部分地限定总体以70表示的各臂内表面的外侧,臂内表面包括多个内圆柱轮廓,该内圆柱轮廓的上面一个是部分地螺旋环绕的引导和前进结构72,其位于与各臂62的顶表面73相邻。在所示的实施方式中,该引导和前进结构72是部分地螺旋环绕内锁法兰形式,其被配置成在旋转中与封闭结构18上的相似结构匹配,如下文中将更具体地说明。然而,可预见在本发明的一些实施方式中,该引导和前进结构72可以可选地为方形螺纹,锯齿螺纹,反角度螺纹或者其它螺纹型或者非螺纹型的螺旋缠绕的不连续前进结构,用于在旋转时可操作地引导封闭结构18并使得封闭结构18在臂62之间向下前进,以及当封闭结构18邻靠在杆21或其它纵向连接构件上时最终扭转(torquing)。可预见臂62具有断开延伸部(break-off extension)。
相反的一对圆形工具接收和接合孔74形成在臂62的接近顶表面73的外基本圆柱表面76上。此外,在各孔74下方是通孔或孔洞77,其还形成在各外表面76中并通过各外表面76,各孔77具有大体上倒置的U形,该U形孔限定中间向内和向上延伸的保持凸片(tab)78,其在或接近底座60处与各臂62一体地形成,大体从接收件底座60向上且朝向接收件轴线B向内延伸。各孔77延伸通过各自臂表面76至各自内壁表面70。各孔77被设置成从相邻孔74间隔开且与接收件底座60接近或相邻。孔74和77的一些或所有孔可用于在与插件14,保持件12和杆4装配的过程中保持接收件10,当杆与接收件10预装配时将杆本体6植入脊椎的过程中保持接收件10,在将骨锚组件1装配至柱21或其它纵向连接构件以及封闭结构18的过程中保持接收件10。可预见工具接收槽或孔可被配置成多种形状和尺寸且被设置在接收件臂62上的其它位置处。
通常向使用者提供的组件1中,插件14通过一对向内延伸保持凸片78保持在接收件中,该凸片78通常是一定弹性的,在与杆4的装配过程中牢固地保持插件14,且将插件14相对于接收件10在臂62之间的上部位置(upward position)保持相对固定直到插件14被向下按压至与杆上部分或头部8锁定摩擦配合。在将封闭顶部18旋转或扭转至柱21或其它连接构件上的过程中,保持凸片78有利地将插件14保持在中间位置(插件臂被保持在与接收件臂对齐)。该对置的保持凸片78包括外表面,以及还有多个内表面用于与插件14接触。该凸片表面包括第一外表面80,其从底座60延伸且朝向接收件轴线B向上和稍向内倾斜。第二向内倾斜表面81与表面80相邻,且以相对于表面80成一角度朝向轴线B被定向。该表面81大体在接收件外周至内臂表面70之间延伸。与表面81相邻的是凸片顶表面82,其朝向轴线B延伸且基本垂直于该轴线B。内部插件接合表面84基本垂直于顶表面82。该表面84与下凸片表面85相邻且与其相垂直。示出的插件接合表面84具有稍稍凹进或圆柱形状(还可为平坦的),其尺寸设置和成形为与插件14的外基本圆柱表面接合,如下文中将更具体地说明的。下表面85与顶表面82平行。保持凸片78是稳固的,但具有一些弹性,当如图所示将插件14与接收件10装配时在插件14的旋转过程中该保持凸片78被从轴线B向外推,例如在图30中示出。各保持凸片78还包括相反的侧表面88,其部分地限定通孔77的U形部分。孔77还由顶表面89、相对的外基本平坦侧表面90、以及一对间隔开的弯曲底表面91限定。
返回至接收件臂62的内表面70,位于引导和前进结构72下方的是不连续的圆柱表面92,其部分地限定了用于引导和前进结构72的终止特征(run-out feature)。该圆柱表面92被尺寸设置和成形为接收插件14,如下文中将更详细地说明。表面92的直径比引导和前进结构72的直径稍大。所示的接收件10还可包括位于表面92上方和下方的倾斜的、阶梯的或倒角的表面。该表面92不仅被U形通道64分隔,还可由各通孔77分隔。在圆柱表面92的底座处的下部分倾斜或阶梯突出部(ledge)94朝向接收件底座60向下倾斜并朝向轴线B向内延伸,该表面94终止于完全围绕接收件底座60延伸的圆柱表面95,且因此在各臂62下方延伸并与下座68相邻。因此该内表面95限定接收件底座60的上和内部分。该圆柱表面具有一直径,其稍小于表面92的直径。通孔77的下腿由延伸通过表面95的表面88部分地限定。表面95终止于突出部表面或腔室顶部96,其从轴线B向外延伸离开,该表面96基本与轴线B垂直,但可以是倾斜的。表面96是环形的,且限定内腔体61的保持环扩展部分或腔室的上顶部或者止挡部(stop),内腔体61进一步由相邻的向外倾斜表面97以及与该表面97相邻的圆柱表面98限定。表面97用作止挡部,其用于并与向外和向上突起保持柄脚(tangs)或板滑动配合,如下文中将更详细地说明。该圆柱表面98具有比圆柱表面95的直径更大的直径。圆柱表面92、95和98都与接收件轴线B居中地对齐并平行地延伸。限定通孔77的下表面部分91延伸进入并通过倾斜表面97。表面98限定圆周凹部,其被尺寸设置和成形为在装配过程中在杆8向上朝向通道64移动时围绕杆上部分8膨胀时接收保持件12。可预见凹部可以是逐渐变细或圆锥配置。
在其间具有环形台阶表面102的一对圆柱表面100和101,以及在表面101下方且与表面101相邻处的下环形台阶103,为保持件12提供下座,如下文中将更具体地说明。表面102和103基本垂直于表面100和101和接收件轴线B。表面100、101、102和103位于底座60的下部分中的圆柱表面下方,且被尺寸设置和成形为当保持件处于如图35-38中所示的收缩的部署位置(reduced deployment position)时紧密地接收和围绕保持件12下底座部分和下裙座或下结构。因此,圆柱表面101具有比圆柱表面98更小的直径,该圆柱表面98限定保持件12的扩张区域或扩张腔室。该表面101通过一个或多个倾斜、弯曲或圆锥的过渡台阶表面104结合或连接至表面98。表面104允许将保持件12滑动或标称(nominal)或部署定位进入表面100和101限定的空间中,且最终将保持件12座靠在下基本水平环形表面102和103上。
位于环形座表面103下方且与其相邻的是下边缘或凸缘表面106,其与倾斜的或扩张形底部开口表面107连通,该表面107与底座60的外底座或底表面108连通,限定进入接收件10的底座腔体61中的下开口,其大体以110指示。在本发明的一些实施方式中,可预见可在底座表面108的一部分中以及在表面107、106和100-104的一些部分中形成弯曲的切口或杯形的表面,该表面107、106和100-104基本居中地定位且直接地位于一个臂62下方。该杯形的表面可被尺寸设置和成形以提供间隙,其用于杆4和接收件10之间的增大的铰接角度。
具体地参考图1和11-16,下开口或切口(split)摩擦配合保持件12,其操作以将杆上部分8捕获在所示的接收件10中。在装配和操作的一些阶段,保持件12被部分地限制在接收件中,被捕获在接收件腔体61中在表面97下方的位置处,一旦向下布置进入接收件腔体61,该保持件12可相对于接收件旋转,但不相对于其枢转,且不容易从接收件移出。该保持件12具有中心轴线,其在杆上部分8和保持件12被安装在接收件10中时可操作地与接收件10的轴线B相同。保持件12包括基本环形的不连续本体115,其具有基本圆柱的外表面116。上部结构(superstructure)从本体115向上和向外延伸并与本体115一体形成,该上部结构包括两组挠性的板或柄脚,具体而言,内板或柄脚117和外板或柄脚118,该板117和118成对地对齐向上延伸,允许板或柄脚对之间的横向空间,以在保持件12与接收件10内表面的装配过程中提供间隙(参见如,图24和25)。所示的实施方式包括六对内和外板或柄脚117、118,但可预见可使用更多或更少的板或柄脚。这些对的板或柄脚大体关于本体115均匀地间隔开。还有与本体115一体的六个外不连续圆柱支撑表面120,各表面120位于外板118中的一个下方。在表面120的下方,圆柱表面116形成下外圆柱裙部121,该裙部121仅由一间隔断开,在下文中将更具体地说明。外表面116与底表面122相邻,且还包括位于外板118之间的部分123。表面部分123示出为基本平坦的,但可以是圆柱的,大体具有与表面116相同的直径。在各板118处,表面116与突出部表面124相邻,该突出部表面124进而与一外支撑表面120相邻。下裙部121和突出部表面124,以及表面120是接收件座表面,如下文中将更详细地说明。在所示的实施方式中,表面116与板117和118或者保持件底部123相接的过渡区域是弯曲的或斜切的。各本体部分123与本体顶表面126相邻,该本体顶表面126基本位于板117和118对之间。各顶表面部分126的外形是基本平坦和梯形的。
该内板117各包括基本平坦的外表面128和凹形的内表面129,表面129各是部分的圆弧的且部分地圆柱的,构成不连续的弯曲表面,其被尺寸设置和成形为与杆头部8摩擦配合接合,最佳地如图13中所示以及在下文中将更详细地说明。然而,可预见板内表面129还可以是平坦的或者包括边缘或者其他表面特征,用于在装配和操作过程中,且在将骨螺钉组件的多轴机构锁定之前,抓握但不将保持件12锁定至杆头部8。板117大体朝向保持件12的中心轴线向内倾斜,且因此最终向内朝向杆头部8。各板117包括顶表面130,其是基本平坦的,且在保持件位于如图15所示的中性(neutral)位置时基本平行于底表面122而延伸。
外板118各具有平坦外表面132,平坦内表面133和平坦顶表面134,该平坦顶表面134相对于保持件底表面122一倾斜角度而倾斜。表面134垂直于相邻的表面132。板118从板117大体向外延伸离开,以及从保持件本体115的中心轴线向外和向上延伸。各表面133面向一个板117的外表面128。本体表面126被成为各对板117和118之间的窄条。板117和118是弹性的,板可关于杆头部8扩张,且在运输和一些装配步骤中板118可向内压缩地和弹性地保持接收件内表面。接着板118在接收件腔体61中返回至初始形状,将保持件12捕获在接收件10中,但仍允许保持件12相对于接收件10关于接收件中心轴线B旋转。
保持件环12由弹性材料制成,如不锈钢或钛合金,从而在装配的多个步骤过程中,保持件12本体115可扩张且保持件的凸片或板117和118可被操作,如下文中将更详细地说明。保持件12具有大体以141指示的中间通道或中空通孔,其从内板顶表面130至保持件本体115的底表面122而完全通过保持件12。限定本体115的通道或孔141的表面包括与保持件本体底表面122相邻的不连续内下截头圆锥表面143,与截头圆锥表面143相邻的窄的基本圆柱表面145,以及与圆柱表面145相邻的不连续环形台阶146,该表面146与底表面122基本平行,且在表面145和内表面129的下圆柱部分129’之间延伸,该内表面129部分地形成内板117。表面145和146终止于边缘147,边缘147被设置成和配置成与杆表面34接合,如下文中将更具体地说明。与台阶146相邻的内圆柱表面129’形成连续的内圆柱壁,除了以148指示的切口(slit),该切口148延伸通过本体115。该切口148形成裂口(split)或者开口环保持件12,该切口完全切穿保持件本体115。在一些实施方式中,该切口可延伸与底表面122成钝角。在所示的实施方式中,切口148基本垂直于表面122而延伸。切口148主要地用于在与杆头部8的套接或卡接装配过程中保持件的扩张。然而,在与接收件10的装配过程中,切口148还压缩,如下文中将更详细地说明。切口148在本体顶表面126和底表面122之间延伸,并基本居中地位于两对板117和118之间。此外,在切口148的位置处,弯曲的凹进、切开表面149形成在底表面122和截头圆锥表面143中。该切开表面149还延伸到圆柱表面145中并将在切口148的任一侧的台阶146的一部分移除。表面149是圆弧的或者另外地弯曲的,从而与杆头部8在表面34处接合,如下文中将更详细地说明。在所示的实施方式中,切开表面149基本平均地位于切口148的任一侧,以在杆8和保持件12之间提供期望的增大方向角度,且因此提供在杆8和接收件10之间提供期望的增大的铰接角度。半限制的保持件12相对于接收件10的旋转性允许将该增大的铰接角度操作和设置至外科医生期望的位置。弹性保持件12的贯穿切口148由第一和第二端表面152和153限定,当保持件处于中性或标称状态时该第一和第二端表面152和153被设置成彼此基本平行地间隔的关系。端表面152和153都被设置成与底表面122垂直,但在一些实施方式中可被设置成与其成钝角。表面152和153之间的宽度是窄的,以在操作过程中为保持件12提供稳定性,但是足够地宽以在装配过程中允许保持件的一些压缩,如下文中将更详细地说明。由于保持件12可以基本中性的状态顶部加载,且在多轴机构的锁定过程中最终扩张,所以切口148的宽度可比底部加载压缩保持件环所要求的小得多。已经发现一旦保持件12关于杆头部8扩张,则保持件12可返回至新的标称或中性方向,其中在表面152和153之间的间隔稍地大于如图12的标称状态中所示的间隔。如下文中将更详细地说明,组件1有利地提供至插件14和保持件12的通路以在将组件1与柱和封闭顶部锁定之前,允许将保持件12向下按压至接收件座部分上并根据需要收缩进入接收件10内圆柱表面的保持件12。
例如,通过具体地参考图1和17-23,示出了锁定压缩插件14,其被尺寸设置和成形为被接收件10接收在在上开口66处被载入接收件10中。该压缩插件14具有操作中心轴线,其与接收件10的中心轴线B相同。在操作中,插件有利地与骨螺钉杆上部分8摩擦接合,以及以干涉配合接合与接收件10相接合,将杆4锁定在相对于接收件10期望角度位置,接收件10保持在该锁定位置,即使例如柱和密封顶部稍后被移除且柱由另一个柱或另外的纵向连接构件或构件部件替换,例如图52-72中所示的套筒中的一个。如果需要则外科医生还可利用插件接合工具(未示出)释放该锁定位置。如下文中关于图47-51中所示的可选插件214更具体地说明的,在本发明的一些实施方式中,插件不具有接收件干涉配合特征。该锁定插件14以及非锁定插件214优选地由实心弹性材料制成,例如不锈钢或钛合金,从而如果需要,插件的一些部分可被抓住、夹紧或按压,以及通过释放工具(未示出)从接收件10脱离楔合(un-wedged)。
锁定压缩插件14包括本体156,其具有多个直径的圆柱表面,本体156与一对直立臂157一体形成。本体156在臂157之间具有外基本圆柱表面158。在各直立臂157下方是非连续、圆柱、干涉配合表面159,其从臂和本体外基本圆柱表面160向外延伸,表面159的直径比表面160的直径更大。在各表面159下方是不连续圆柱表面161,其具有与表面160相同或相似的直径。截头圆锥或弯曲过渡表面或突出部162在各表面159与相应的下圆柱表面161之间横跨延伸。下表面161还与基本平坦和环形的底表面164相邻。插件14还包括基本平坦的臂顶表面165,其被设置成与底表面164相反。矩形的、基本居中定位的工具接收孔167形成在各臂表面160中接近各顶表面165处,该孔167完全延伸通过各自臂157。直接横过各臂157的通孔167有利地允许通过工具从臂157的外侧表面160或内侧表面抓持插件14。位于各孔167正下方的是浅孔168,其也居中地设置在臂表面160上,该孔168还与干涉配合表面159相邻。孔168的形状是基本方形的,且没有完全地延伸通过臂表面160。槽170从各孔168延伸,该槽17被尺寸设置和成形为在将插件14与接收件10装配的过程中在插件14旋转到位时(例如如图29和30中所示)接收并滑动地接合接收件保持凸片78,孔168最终地捕获各凸片78,如下文中更具体地说明。
转向插件15的内表面,大体以171指示的通孔被主要地设置在本体156内并穿过本体156,且与大体U形通道连通,该U形通道由基本由直立臂157限定的鞍形表面173形成。接近顶表面165处,鞍形表面173是基本平坦的,其中通孔167从其延伸穿过。鞍形部173具有下座部174,其被尺寸设置和成形为与柱21或其它纵向连接构件紧密地、贴合地接合。可预见,可选的实施方式可被配置成包括平坦的保持表面,其紧密地保持方形或矩形条以及保持圆柱柱形、绳、或带导套绳的纵向连接构件。该臂157被设置在从本体156向上和向外延伸的通道的任一侧上,并终止于顶表面165处。臂157被尺寸设置和配置成最终被设置在接收引导和前进结构72下方。可预见在本发明的一些实施方式中,臂可向上延伸,且封闭顶部被配置成使得臂和更具体的表面165最终地与封闭顶部18直接结合,用于将多轴机构锁定,例如在柱21是由可变形材料制成时。在该实施方式中,插件14可包括另外的旋转阻挡结构或者特征,其邻靠接收件10的内壁上设置的配合结构,防止当封闭顶部旋转至与插件接合时,插件相对于接收件旋转。在所示的实施方式中,表面165最终被设置成与封闭顶部18成间隔开的关系,从而封闭顶部18仅与柱21摩擦接合,将柱21向下压靠在座表面174上,插件14进而压靠杆4上部分8,该杆4上部分8压靠保持件12以将骨螺钉组件1的多轴机构锁在预期的角度。
大体以171指示的孔通过内圆柱表面176基本限定在本体156上,该内圆柱表面176与座174和下凹部基本圆弧或部分球形表面178连通,该表面178具有与杆上部分8的表面34的半径相同或基本相似的半径。表面178终止于底座表面164。位于圆柱表面176和圆弧表面178之间或者沿着圆弧表面178设置的是杆抓握表面部分,大体以180指示。该抓握表面部分180包括一个或多个阶梯表面或脊,其被尺寸设置和成形为当插件14被锁靠在头部表面34上时抓握并刺入杆头部8。可预见阶梯表面部分180可包括更多或更少的阶梯表面。可预见杆抓握表面部分180以及还有球形表面178可另外地或可选地包括粗糙的或纹理的表面或表面处理,或者可被刻痕、滚花等,用于促进与杆上部分8的摩擦接合。
压缩插件14通孔171被尺寸设置和成形以当杆本体6在连接有接收件10的情况下被驱动进入骨中时,接收驱动工具(未示出)穿过其中,该驱动工具与杆驱动特征46接合。此外,在本发明的一些锁定实施方式中,孔接收操作工具(未示出)用于将插件从与接收件的锁定位置释放,该工具向下压在杆上且还在位于臂中的通孔167处或者通过其它工具接合特征抓握插件。例如,用于从接收件10释放插件的操作工具还可从接收件穿过该接收件中的孔77进入该孔167。从而,工具可被配置成从接收件10的内侧和外侧释放锁定插件。各臂157和插件本体156可包括多个表面特征,例如切开凹口,斜面等等,以为在不同的装配阶段过程中将插件14插入接收件以及与保持件12配合中提供足够的间隙,如下文中将更具体地说明。
插件本体156圆柱表面158具有的直径比接收件10的引导和前进结构72的顶部之间的直径稍小,允许将压缩插件14顶部加载进入接收件开口66中,其中在将插件14插入接收件10的过程中插件14的臂157被设置在接收件臂62之间。一旦插件14的臂157被大体设置在引导和前进结构72下方,则插件14关于接收件轴线B顺时针方向旋转到位,直到接收件保持凸片78位于孔168中,如下文中将更具体地说明。
参考图1和36-37,所示的长形柱或长形连接构件21(仅示出了其的一部分)可以是用于重构脊椎手术中的多种植入物的任一种,但通常是圆柱形、长形结构,且具有一致直径的外基本平滑圆柱表面22。杆21可由多种金属、金属合金、非金属以及可变形的且较不能压缩的塑料制成,包括但不限于杆由弹性橡胶、聚醚醚酮(PEEK)和其它类型的材料制成,例如聚碳酸酯聚氨酯(PCU)和聚乙烯。
用于组件1的纵向连接构件可采取多种形状,包括但不限于椭圆形、矩形或其它弯曲或多边形横截面的杆或条。插件14的形状可被修改从而紧密地保持用于组件1的具体纵向的连接构件。组件1的一些实施方式还可使用张紧绳(tension cord),如在下文中将参考图52-74详细说明的。该绳可由多种材料制成,包括聚酯或其它塑料纤维、丝或线,例如聚对苯二甲酸乙二醇酯。此外,纵向连接件可以是较长的整体动态稳定连接构件的元件,其中圆柱形或条形部分被尺寸设置和成形为由具有U形、矩形或其它形状通道的接收件的压缩插件14接收,用于紧密地接收纵向连接构件。例如,纵向连接构件可一体地或以其它方式固定至可弯曲或阻尼部件(damping component),其被尺寸设置和成形为位于相邻对的骨螺钉组件1之间。阻尼部件或缓冲器(bumper)可在骨螺钉组件1的一侧或两侧处连接至纵向连接构件。根据期望的应用,纵向连接构件的杆或条(或杆或条部件)可由从可变形塑料至硬金属范围内的多种材料制成。因此,本发明的条和杆可由以下材料制成,包括但不限于金属和金属合金,包括但不限于不锈钢、钛、钛合金和钴铬;或者其它合适的材料,包括塑料聚合物,如聚醚醚酮(PEEK)、超高分子量聚乙烯(UHMWP)、聚氨酯和复合物,包括含有碳纤维的复合物,天然或合成弹性材料,诸如聚异戊二烯(天然橡胶),以及合成聚合物、共聚物和热塑弹性体,例如,诸如聚碳酸酯聚氨酯弹性体的聚氨酯弹性体。
例如,参考图1和36-37,所示的封闭结构或封闭顶部18,其中组件1被可旋转地接收在接收件10的间隔开的臂62之间。应注意,封闭顶部18可以是旋入或滑入封闭结构。所示的封闭结构18是基本圆柱形的且包括法兰形式的外螺旋环绕的引导和前进结构182,其可操作地与设置在接收件10的臂62上的引导和前进结构72接合。根据本发明的一些实施方式使用的法兰形式可采取多种形式,包括在本申请人的美国专利第6,726,689号中说明的,该专利通过引用结合于此。尽管可预见该封闭结构引导和前进结构可以可选地为锯齿螺纹、方形螺纹、反向角度螺纹或如其它螺纹或非螺纹型螺旋环绕前进结构,用于可操作地在旋转时引导封闭结构18在臂62之间向下前进,且具有特性以在封闭结构18前进至通道64中时阻止臂62的外张,优选这里所示的法兰形式如申请人的美国专利第6,726,689号中所更加详细地说明,该法兰形式提供的增加的强度有利地配合,且抵消由可更有利地接合纵向连接构件元件的接收件10的任何减小的外形引起的强度的任何减小。所示的封闭结构18还包括顶表面184,其具有孔的形式的内驱动部186,该孔被示出为六角驱动部(hex drive),或可以是例如星形内驱动部(例如以商标TORX销售的),或者其它内驱动部,如带槽的、三翼、扳手、两个或多个多种形状的孔,等。被尺寸设置和形状设置成用于与内驱动部186接合的驱动工具(未示出)用于可旋转接合封闭件18和接收件臂62,以及如果需要,用于将封闭件18从接收件臂62松开。还可预见,在一些实施方式中,封闭结构18可以可选地包括断开头部(break-off head),其被设计成在预定转矩,如70至140英寸磅下从封闭件的底座折断。该封闭结构还可包括具有用于封闭件移除的内部驱动部的底座。封闭件的底座或底表面188是平坦的且还包括尖端(point)189以及突缘(rim)190,用于在本发明的一些实施方式中接合并穿过进入杆21的表面22。应注意,在一些实施方式中,封闭件顶部底表面188不包括尖端和/或突缘。封闭顶部18还包括中空通孔(未示出),其沿着其中心轴线延伸,并通过其顶表面和底表面。该通孔提供穿过封闭件18内部的路径,用于让一长度的线(未示出)插入其中以提供将封闭顶部插入接收件臂62的引导。在图39和40中示出了与可变形柱(如PEEK柱21’)一起使用的可选的封闭顶部,如顶部18’,其包括底表面188’,该底表面188’具有带有中间凸块189’的圆顶底表面190’,以代替封闭顶部18的尖端和凸缘表面。另外,封闭顶部18’包括引导和前进结构182’,顶表面184’,和内驱动特征186’,其分别与封闭顶部18的引导和前进结构182,顶表面184和内驱动特征186相同或基本相似。
组件1接收件10、保持件12和压缩插件14通常以出厂设置(factorysetting)而装配,其包括用于保持和对齐部件和相对于接收件10操作保持件12和插件14的工具。在一些情况下,该杆4还在工厂中与接收件10,保持件12和压缩插件14装配。在其它情况下,期望首先植入杆4,接着在插入点处加入预装配接收件、保持件和压缩插件。这样,外科医生可有利地和更容易地植入和操作杆4,通过杆分开或压缩脊椎,并在杆上部分或头部周围工作而不受到配合的接收件阻挡。在其它情况下,期望外科人员将预期尺寸和/或种类(如,粗化加工上部分8和/或杆6上的羟磷灰石的表面处理)的杆与接收件、保持件和压缩插件预组装。允许外科医生选择合适尺寸或处理的杆4有利地减少了库存要求,从而减少了总的成本并改进了物流和分配。
在图24-30中示出了接收件10、保持件12和压缩插件14的预装配。具体地参考图24,首先保持件12被插入上接收件开口66,以外板118为前导,其中板118顶表面134朝向一个臂62,而保持件底表面122朝向相反臂62(以虚线示出)。接着保持件12以侧向方式向下进入通道64,且部分地进入接收件腔体61,随后倾斜保持件12,使得至少一个板顶表面134位于接收件保持凸片78中之一的表面85下方,且相反的保持凸片78大体被设置在一对板118之间,例如在保持件切口148处或其附近处,如图24中的实线所示。然后,参考图25,保持件12被倾斜至一位置,其中保持件12的中心轴线大体与接收件中心轴线B对齐,且接收件保持凸片78各自设置在相邻板118对之间并在彼此相反地设置的保持件本体顶表面126上方延伸,其中各凸片表面85被设置在顶表面126或切口148正上方。图26示出了接收件和保持件在图25中所示的装配的中间阶段的底视图,示出了保持件12的切开部分149怎样大体位于构成接收件腔体61的内表面之内。图25和26还示出了处于压缩状态的保持件12,其中切口表面152和153处于接近接触状态,从而圆柱表面120滑动经过接收件内表面95。
参考图27和28,在将板118设置在保持凸片78之间后,保持件12下降进入接收件腔体61,其中弹性板118通过工具或者通过向下力被向内按压,其中该向下力由于与接收件表面95接合从而使板118朝向轴线B压缩。应注意,图27中示出的保持件12关于接收件轴线B从图25中所示的位置旋转。在将保持件载入接收件腔体61中之前该旋转是不必须的,但是在这里示出以向读者提供保持件12的横剖视图,其更清楚地示出保持件板117和118相对于接收件腔体表面的位置和方向。进一步参考图28,保持件12被向下按压直到保持件处于接收件10中的期望的临时位置,其中板118外表面132与接收件内表面95接合,从而在将插件14装载和初始地装配至接收件10中的过程中将保持件12在该位置保持在接收件中。这时,保持件12仍没有完全被捕获在接收件底座腔体61中,但无法容易地被移除,除非板118被工具朝向彼此挤压。
参考图29-31,接着压缩插件14经由上开口66被载入接收件10中,其中底表面164朝向接收件臂顶表面73,且插件臂外表面160位于相反的接收件臂62之间。然后插件14朝向接收件底座60降低,直到插件14臂上表面165与由圆柱表面92部分限定的引导和前进结构72下方的终止区域(run-outarea)相邻。之后,插件14关于接收件轴线B旋转(参见图30中所示的箭头K),直到上臂表面165直接位于引导和前进结构72下方,其中插件14的U形通道173与接收件10的U形通道64对齐。在一些实施方式中,在旋转过程中插件臂需要被稍稍压缩以通过接收件臂62的一些内表面70。具体地参考图30和31,随着插件14关于轴线B旋转,接收件保持凸片表面84沿着插件槽表面170滑动且接着被捕获在插件孔168中。该插件孔168帮助保持保持插件14和接收件10之间的期望对齐,并阻止两个部件之间的相对旋转。然而,由于孔168没有将插件相对于接收件竖直地固定,所以插件14与接收件10之间的相对竖直移动是可能的。此外在这时,插件底表面164位于板118的顶表面134上。然而,板118和接收件内表面95之间的摩擦接合阻止保持件12,且因此阻止插件14继续向下落入接收件10腔体61中。现保持件12和插件14处于期望的位置,与单独的杆4一起作为组件用于运输以及装配。通过引导和前进结构72以及通过位于插件下方的保持件12将插件14完全捕获在接收件10中,该引导和前进结构72防止插件14向上和向外移动通过接收件开口10。
通常,运输至或以其它方式提供至最终用户的接收件和保持件组合具有弹簧型的板118,其压靠(wedge against)在接收件上,如图31中所示。该接收件10、保持件12和插件14组合现预装配并准备好用于在工厂,在植入之前由外科人员装配至杆4,或者直接至植入的杆4上,如下文中将说明的。
如图31中所示,通过使用合适的驱动工具(未示出)旋转杆4,使得该骨螺钉杆4或者由装配的杆4、接收件10、保持件12和压缩插件14构成的整个组件1旋至骨中,如脊椎17(以虚线示出),该合适的驱动工具通过在内部驱动部46处与杆本体6接合而可操作地驱动和旋转杆本体6。具体地,脊椎17可被预钻孔以使向骨加压最小,且将引导线(未示出)插入其中以提供将杆4相对于脊椎的布置和角度的引导。通过丝锥(tap)以引导线作为引导而形成另一个塞孔(tap hole)。接着,通过首先将线穿进在底部28的开口且接着从驱动特征46处的顶部开口穿出,骨螺钉杆4或者整个组件1通过中空孔50穿至引导线上。接着通过作为设置引导的线将杆4驱动进入脊椎。可预见可使用引导线和与接收件匹配的可连接支撑工具(attachable towertool)而使得杆和其它骨螺钉组件部件,杆21(在一些实施方式中还具有中间内腔)和封闭顶部18(还具有中间孔)可以经皮肤的或最小侵入外科方式而被插入。当杆4在没有组件1的其余部分的情况下被驱动进入脊椎17时,杆4可被驱动至期望的最终位置或者可被驱动至稍上方或高(proud)的位置,以便于与预组装的接收件、压缩插件和保持件组装。
参考图32,预装配接收件、插件和保持件被设置在杆上部分8上方,直到杆上部分被接收在开口110中。具体地参考图32-35,随着杆上部分8移动至接收件底座的内部61中,杆上部分8被向上压靠在接收件凹部中的保持件12上,该接收件凹部部分地由圆柱表面98限定。随着杆头部8继续向上朝向通道64移动,杆头部表面34将保持件12推靠在插件14上。然而,通过接收件引导和前进结构72阻止插件14向上移动。因此,向上移动的杆头部8推动保持件切口148的张开以及保持件12的本体115朝向接收件圆柱表面98和100的相应向外移动,接收件圆柱表面98和100限定接收件膨胀凹部或腔室,最佳地如图33中所示,而接近顶表面134的保持件板118大体被保持在直接位于插件14底表面164下方的位置处。这时,头部8的球形表面34与保持件内圆柱本体145和边缘147接触。参考图34,随着杆头部8的球形的中间超过保持件表面147,保持件12开始朝向中性或标称位置返回。在球形表面34的半球延伸进入位于保持件中间通道141中的期望捕获位置时,杆表面34与边缘147接触以及与内板117在表面129处接触。凸缘或边缘147表面接触和板117表面129接触的组合弹性地压靠圆弧表面34,提供了在头部8和保持件12之间的非常紧密的摩擦配合,表面34可以在一定力的作用下关于保持件12枢转。因此,在保持件12和杆上部分8之间形成紧密的、非宽松球窝接头。
参考图35,然后将接收件向上拉,或者然后将杆4和连接的保持件12手动向下移动至一位置,其中保持件板118从接收件表面95脱离,允许板118弹性地释放和向外伸展进入中性或接近中性位置,其在限定接收件内腔室61的顶部的接收件环形表面96下方。板118现被捕获在接收件和保持件中,其中任何向上移动导致板顶表面134邻靠接收件表面表面96和/或97。然而,尽管完全捕获,由于使用者能够在将杆相对于接收件锁定之前使保持件关于接收件轴线B旋转,所以保持件/杆组合相对于接收件有利地仅部分地被限制。此外,这时,形成保持件本体表面120和124下方的下裙部的保持件表面121和底表面122都坐靠在接收件的阶梯表面内。具体地,保持件下表面124位于接收件环形表面102上,且底表面122位于环形表面103上。将杆头部8向下压在保持件边缘147上的压力还将保持件本体115向外扩张,其中外表面120压靠在接收件内圆柱表面100上,而下裙部表面121压靠在接收件内圆柱表面101上。由下裙部表面121部分地形成的保持件本体有利地允许头部8较低地坐靠在接收件中,这与其它已知的多轴骨锚不同。如下文中将更具体地说明,裙部特征与保持件杯形表面149的结合允许角度增大而不需要在接收件底部108处或接近接收件底部108处提供切开或杯形表面,其中裙部特征允许更加稳定的下座表面,而保持件杯形表面149允许杆相对于保持件的增大的角度方向且因此相对于整个骨螺钉组件的增大的角度方向。此外,优点是部分地限制的保持件12可相对于接收件10关于轴线B旋转,允许使用者选择接收件10和杆4之间的增大的方向角度的位置。
进一步参考图35,在保持件12向下移动进入接收件10并位于表面102和103上之后,由于接收件弹簧凸片78和/或接收件阶梯表面94阻止插件14的向下移动,除非通过工具或者柱21以及如图36中所示的封闭顶部18将向下力施加在插件上,因此插件14保持与杆头部8上方间隔开地设置。在一些实施方式中,当接收件10被与杆4预装配时,这时可通过将驱动工具(未示出)插入接收件和杆驱动部46中并将杆4旋转和驱动进入脊椎17的期望位置,从而将整个组件1植入。这时,在利用封闭顶部锁定之前,可将接收件10至相对于杆4枢转至期望的角度位置(例如,图41和43中所示的角度方向),这将由保持件12内板117和杆上部分8之间的摩擦接合保持但不锁定。在一些情况下,这时,可期望将插件14锁定至接收件10中,通过向下压在插件上的工具将插件14向下压至与杆头部8锁定接合,该工具通过接收件开口66进入并向下压插件鞍形部153。该工具还可包括(或可选地为)用于抓握接收件的结构,例如延伸进入接收件孔77的带脚的工具或工具部分。或者,如上所解释,插件14可保持在杆头部8上方与之间隔开,直到通过柱21和封闭顶部18向下按压插件14而被锁定到位。如上所述且最佳地如图37和38中所示,插件外表面159的直径被尺寸设置成足够大,以要求通过工具或多个工具或者通过封闭顶部18以足够的力将柱21向下推靠在插件14上,从而将插件14干涉摩擦锁定或在表面159处楔入接收件10,因此表面159被推入接收件的圆柱表面95中。该独立的锁定和释放特征给予外科医生灵活性,以松开封闭顶部并甚至将封闭顶部和柱移除而不影响组件1的多轴机构的锁定,该锚组件用作固定的单向螺钉,其中杆4与接收件10成固定关系,但是该杆保持相对于接收件成期望的角度。例如,参考图39和40,一旦插件如图38中所示被锁靠在接收件上,如果柱和封闭顶部已经与接收件10装配,则封闭顶部18可被松开或移除和/或柱21可被调节和/或移除,且插件14与接收件10之间在接收件表面95处的摩擦接合将保持锁定到位,有利地保持杆4相对于接收件10的锁定角度位置。这时,另一个柱,例如可变形柱21’和配合可选封闭顶部18’可被加载至已经锁定的组件上,以得到可选的组件。该所示的柱21’具有与柱21相同的尺寸,具有圆柱表面22’,但是由诸如PEEK的材料制成,其响应于来自封闭顶部的压力而变形,因此使得具有圆顶表面190’和中间凸块189’的封闭顶部18’成为更加期望的锁定机构,用于将可变形柱18’在接收件10中保持到位。由于组件的多轴机构的锁定不取决于柱21’和封闭顶部18’作用在插件14上的力,因此柱相对于封闭顶部18’或者插件14的任何进一步变形或甚至松开都不会影响插件14与接收件10之间的牢固锁定,且因此杆4保持摩擦地锁靠插件14和保持件12,将杆4锁定在相对于接收件10的期望的角度位置处。
如果期望将插件14相对于接收件10解锁,则可将工具(未示出)插入接收件10的通孔77以及插件14的通孔167中,且可将插件14从接收件10拉开。该工具可包括活塞式部分,用于在将插件14从接收件拉开时直接推在杆上。这时,杆4可相对于接收件10枢转,且期望的摩擦配合返回至保持件12和杆表面34之间,从而在杆4和接收件10之间仍然存在可调节、非宽松关系。如果要求将组件进一步拆开(if further disassembly if theassembly),则可通过与上述用于组件1的过程相反的顺序完成。
返回至图36-38,柱21被设置成以开放或经皮(percutaneous)的方式与至少两个骨螺钉组件1配合。该封闭结构18然后在各接收件10的臂62之间前进。通过与内驱动部186接合的工具使得该封闭结构18旋转,直到到达选择的压力,此时柱21与压缩插件14的U形鞍形部173接合,进一步将插件球形表面178和阶梯杆抓握表面180压靠在杆球形表面34上,阶梯表面180的边缘刺入球形表面34,将杆上部分8压至与保持件12锁定摩擦接合。具体地,由于封闭结构18旋转并向下移动至各自接收件10中,尖端(point)189和凸缘190接合并刺入柱表面22,封闭结构18向下压靠并偏置柱21,至与插件14压缩接合,其将杆上部分8朝向保持件12推动并在保持间边缘表面147与其锁定接合,该保持件12与接收件表面102和103摩擦邻接并向外压靠接收件圆柱表面100和101。例如,可向封闭顶部提供约80至约120英寸磅的转矩用于将骨螺钉杆6相对于接收件10固定。这时,保持件内边缘147接合并刺入杆头部8。这时,内板117可从杆头部8稍稍间隔开,或者仍可与杆球形表面34接触,但不再与表面34紧密或紧紧摩擦接合,且因此不参加杆4和保持件12之间的最终锁定接合。最佳地如图38中所示,由于下裙部表面121和122相对于接收件10的位置和几何形状,以及还由于内边缘147、杆头部8座靠在接收件腔体61低处的位置,因此与不包括该下裙部的保持件相比,允许杆4相对于保持件12的期望的增大的枢转范围,且因此相对于接收件10的期望的增加的枢转范围。如果期望组件1拆开,则可通过与上述用于组件的过程相反的顺序完成。
参考图41-46,示出了杆4相对于接收件10的不同的角度或铰接位置,其中一些完全使用保持件12的切口148和相邻的切开或杯形表面149。例如,比较图43-45,其中杆8枢转朝向并至接合杯形表面149,与图41和42中所示的配置相比,其中杆4在与保持件切口148相反的方向枢转。在图41和42中,其中杆在从切口148和杯形表面149离开的方向枢转,得到的杆与接收件铰接角度是约二十二度(如,向头部的(cephalad)),其在一些情况中是期望的铰接度。图43-46示出了三十三(如,向尾部的(caudad))或稍稍进一步的铰接角度,可能在杆头部8邻靠两个表面149时以及稍稍移动进入切口148形成的间隔时。
图46示出了可选的接收件10’,其包括底表面108’,该底表面108’进一步由一对相反的、阶梯的和凹进的弯曲底表面109’限定。在其它方面,接收件10’与上述的接收件10相同,且因此以与上述关于组件1说明的方式基本相同的方式而与保持件12、插件14、杆4、柱21和封闭顶部18完全配合。正如接收件10,当保持件12完全装配至接收件10’时,保持件12被捕获在接收件内腔体61’中,但是仅部分地限制在其中,保持件可关于接收件10’的中心轴线旋转。因此,保持件12切口148和表面149可与接收件阶梯表面109’的任一个对齐。当保持件表面149与表面109’中的一个对齐时,在杆4和接收件10’之间的至少四十度角的铰接范围是可能的。
参考图47-51,示出了用于与这里前述的杆4、接收件10、保持件12、封闭顶部18和柱21一起使用的可选非锁定压缩插件214。该插件214与这里前述的插件14基本相似,具有插件14的所有特征,除了通孔167和增大的干涉配合表面159。相反地,插件包括形成在臂表面中的一对相反的可选孔166,其没有延伸完全通过插件臂,以及包括圆柱表面259,其与插件14的表面159相似,除了表面259的直径被尺寸设置成容易地在接收件表面95中滑动配合而不是与该表面干涉配合。因此,插件214包括插件本体256,一对直立臂257,圆柱本体表面258,臂外表面260,下圆柱表面261,倾斜突出部262,平坦底部264,臂顶部267,槽270,中间通孔271,鞍形表面273,鞍形座274,内圆柱表面276,下圆弧表面278和杆抓握部分280,以及其它与前述的插件14的以下特征相同或基本相似的特征:各插件本体156,直立臂157对,圆柱本体表面158,臂外表面160,下圆柱表面161,倾斜突出部162,平坦底部164,臂顶部167,槽170,中间通孔171,鞍形表面173,鞍形座174,内圆柱表面176,下圆弧表面178和杆抓握部分180。
各插件孔266是形成在表面260中的凹进,具有与插件14的孔168相似的基本矩形形状。此外,各孔266朝向各自相邻槽270开口并与其连通,用于与接收件保持凸片78装配,该装配方式与这里之前说明的插件14的孔168和槽170之间的配合相似。然而,与限定各孔168的基本平滑平坦表面不同,各孔266还包括基本与顶表面265平行的水平条或桥部分267,该水平条或桥部分267将孔266分为两部分,上部分268和下部分269,各具有基本平坦的表面用于与保持凸片表面86滑动配合。在与接收件的装配过程中,插件214旋转且接收件保持凸片表面84沿着槽270滑动直到其在孔266的下部分269处弹性进入该孔266,各条267在顶表面82处邻靠各凸片78,阻止插件214继续向下移动进入接收件腔体61。因此,与由于干涉配合表面159而不能继续移动进入腔体的插件14不同,在装配和运输过程中,如果需要,插件条267将凸片78捕获在各孔266的下部分269中,将插件214保持在期望的位置,直到插件214通过工具或者通过柱21和封闭顶部18在向下方向被以一定的力按压,凸片78沿着条267的下倾斜表面弹性地滑动,直到凸片78滑动经过条267且凸片表面84弹性进入上孔部分268,例如如图51中所示。
插件另外地与接收件10,保持件12,杆4,柱21和封闭顶部18以与前述关于组件1所述的相同的方式装配,除了当杆4被锁定定位时插件214不需要被向下推至与接收件10锁定干涉配合。如果封闭顶部18被松开或者如果封闭顶部18和柱21被从组件1移除,则插件214还将在接收件10中向上移动,且杆4将不会保持关于保持件12和接收件10锁定。
参考图52-74,根据本发明的多轴骨螺钉组件1(以及下文中说明的可选的骨螺钉组件1001和2001)可使用长形连接构件组件,其有时被称作“软”或“动态(dynamic)”连接件,其可包括一个或多个具有配合的、垫片、缓冲器、内张紧绳的套管,且可包括一个或多个端部阻断器或者固定器用于将绳固定至连接件组件。本申请人的申请日为2010年6月15日申请号为12/802,849的美国专利申请(美国公开号2010/0331887)中说明了多个该连接器元件,该专利申请通过引用结合于此。参考图57,示出了与硬的、无弹性、带法兰套管304装配的骨螺钉1,张紧绳306延伸穿过该套管304,套管和绳可作为该长形连接组件或系统的一部分,如美国专利申请第12/802,849号中所述。例如,在图52-56中还更具体地示出了该套管304。在图64中,示出了与骨螺钉组件1装配的另一个可选的套管305。在图66-70中以更具体的细节示出了该套管305。例如,在图57-59和61-63中示出了绳306。
具体地参考图52-63中所示的套管304,在图62和63进一步示出了配合端绳阻断器或固定器310,其具有绳固定定位螺钉312,弹性端缓冲器(bumper)314和可以是弹性或非弹性的基本圆柱形间隔器316。该圆柱形、管状间隔器316在接近其一端部处包括外环形槽,帮助弹性压缩。然而,在另外的实施方式中,垫片可不具有槽。间隔器在与槽相反的端可被切割为期望的长度。绳阻断器310、缓冲器314和间隔器316各自围绕绳306而设置,通常将间隔器316设置在整个组件(未示出)的各对骨锚1之间,该组件可包括至少两个骨锚1,但可包括任何数量的骨锚,其中绳306在任一端固定在终端或末端骨锚1,或者固定在末端阻断器310或其它固定构件,其它固定构件可以例如为绳与硬质柱连接器。图中所示的该管状缓冲器314和管状间隔器316是透明的,允许看到套管304和张紧绳306。然而,可预见在其它实施方式中,缓冲器和间隔器可由不透明或半透明的材料制成。还如图60和61中所示,使用了两种类型的骨螺钉封闭件,上文中关于组件1说明的滑动或滑移封闭顶部18或者绳抓握封闭顶部18”。在图65和66中还示出了封闭顶部18”,封闭顶部18与顶部18”的区别仅在于顶部18”不包括底部突缘或底部尖端,而包括绳固定或穿过延伸部317,其具有用于抓握绳306的底部表面318。参考图58,滑动或滑移封闭顶部18与各自套筒304接合,但不与绳306接合,允许绳在多轴螺钉1中滑动或滑移。参考图61,该抓握封闭顶部18”在孔360处延伸通过套筒304,且表面318将绳306抓握和固定靠在限定套筒304的孔336的内表面上,且因此将绳306相对于与封闭顶部18”配合的多轴螺钉1固定。
尽管未示出,套筒304以及绳阻断器310可包括在其任一侧的管状延伸部,其可被尺寸设置和成形为延伸进入间隔器316或缓冲器314的内腔或孔。有时期望该间隔器与套筒重叠,以提供用于连接构件的额外的抗剪切支撑。缓冲器314还围绕绳306延伸,且通常由弹性材料制成,而外间隔器316尽管通常是弹性材料的,可由具有不同硬度的材料制成,通常(不总是)比缓冲器314的材料更硬和压缩性更低。套筒304以及在一些实施方式中的间隔器316通常由硬的、非弹性材料制成,例如金属或金属合金,例如钴铬合金。套筒304的法兰部分位于骨螺钉接收件10的任一侧上,该法兰直接邻靠在间隔器316或缓冲器314上,该法兰径向地向外延伸至一程度以完全地接合相邻垫片或缓冲器的端部,得到在连接件组件的单独元件之间的稳定的、可靠的、基本完全的接触。此外,如果需要,法兰允许在植入连接件之前对长形连接件的组装和动态设置,其中绳306被设置成张紧且至少缓冲器314被压缩地设置。在本发明的一些实施方式中,可在将长形连接件组件套管304(或305)连接至骨螺钉1之后,进行绳316的张紧以及缓冲器314以及可选地间隔器316的压缩。
具体地参考图57,示出了具有套管304的骨螺钉组件1。具体地参考图52-56,套管304包括本体部分334,其大体被尺寸设置和成形为围绕绳306且被接收在多轴骨螺钉1接收件10中。通孔336居中地延伸通过本体部分334,孔336被尺寸设置和成形为滑动地接收绳306。在本体部分334的任一侧的是一对相反布置地间隔开的径向延伸的法兰338。本体部分334包括环形平坦顶表面340,基本圆柱底表面341,和与底表面相邻的相反的平坦表面342,以及设置在各表面342上方的相反布置的部分圆柱或另外地突起部分344。顶部环形表面340部分地限定各突起部分344。本体334被尺寸设置和成形为紧密地配合在骨螺钉接收件10的内壁表面中。部分344用于将套管304居中地设置在骨螺钉接收件10中,还有利地增强了套管,产生更好的载荷传递。可预见在一些实施方式中,由于可通过部分或多个部分344来将套管相对于骨螺钉接收件10居中,所以法兰338可被减小或者取消。
在所示的实施方式中,各法兰338具有与外平坦环形表面348相邻和垂直的基本圆柱形外表面346,该外平坦环形表面348被尺寸设置和成形为用于直接邻靠在缓冲器或间隔器上。孔336延伸通过各平坦表面348。该圆柱表面346在其下端被截去,形成底表面350,其还与表面348相邻和基本垂直。多个弯曲过渡表面351朝向与本体下圆柱表面341相邻地设置的更加一致的法兰352弯曲,该表面351被尺寸设置和成形以当套管被插入接收件U形通道64和坐靠在插件14的座174上时通过与接收件U形座68邻近设置的接收件插入表面63。本体下圆柱表面341被尺寸设置和成形以被接近接收件座68的插件鞍形部173紧密地接收。与过渡表面351和圆柱形表面346相邻,各法兰包括内相对朝向表面353。在表面353和套管本体334之间是凹进的杯形表面355,其被尺寸设置和成形以接收并部分地包围接收件臂表面71在臂的内和外朝向表面之间过渡的一些部分。例如,参见图57和62,表面353还接收接收件外表面76的部分并围绕其弯曲,该接收件外表面76被设置成与过渡臂表面71相邻。在接近法兰的顶本体表面340和还邻近外圆柱表面346处,法兰还包括内圆柱表面356,其被尺寸设置和成形为提供用于接收封闭顶部18或18”的间隙。应注意,法兰338的本体部分334以及内表面可被尺寸设置和成形为可接收至和可磨擦地固定至多种单轴或多轴螺钉头部或接收件,包括但不限于,接收件10。
参考图52、54和56,孔360在顶表面340处形成在本体334中,且居中地设置在法兰338之间。孔360横向于通孔336且与其连通。孔360被尺寸设置和成形以将封闭顶部18”的绳穿过部分317接收在其中,最佳地如图61中所示。在图57-59中,示出了具有封闭顶部18的套筒304。顶部18没有向下延伸进入通孔360,允许绳306在孔336中自由地滑过。
套筒304,以及具有定位螺钉312的绳阻断器310可由多种无弹性材料制成,包括但不限于金属,包括钴铬等的金属合金,以及无弹性塑料,包括但不限于塑料聚合物,例如聚醚醚酮(PEEK)、超高分子量聚乙烯(UHMWP)、聚氨酯,以及复合物,包括含有碳纤维和不同材料的层的复合物。
参考图57,示出了套管304,其装配有骨螺钉1且具有在其每一侧上的一对圆柱和管状间隔器316,该套管和间隔器围绕绳306,还参考图62,示出了与间隔器316和阻断器310二者,和缓冲器312,以及绳306配合的套管304,使用套管304、绳306、绳阻断器310、缓冲器314以及一个或多个圆柱形间隔器316的连接构件组件可如下装配:首先,在将两个或多个骨螺钉1植入后,测量螺钉之间的距离。此后,根据骨螺钉之间的测量值将间隔器316切至期望的长度。由于套管304由硬质材料制成,该材料通常是金属或金属合金,如果期望使用具有管状延伸部的套管,则在手术过程中将管状部分切割至期望的长度是不实际的。因此,通常向最终使用者提供多种套管304,其具有至少三种不同管部分长度。其后,将套管304、间隔器316、缓冲器314和绳阻断器310(或者在每端上的两个绳阻断器,具有或不具有相邻的缓冲器)以期望的顺序进给至绳306上,以得到期望的组件,该方式与通过引用结合于此的美国专利申请第12/802,849号中具体说明的方式相似。应注意,绳306通常比附图中所示的更长,且接着在与连接器组件的剩余元件完全装配,张紧和固定至阻断器310之后,在其端部处被切割至一长度。在本发明的一些实施方式中,可将单个阻断器、缓冲器/阻断器组合或者杆/绳连接件(或者其不同组合)可被设置在组件的每一端,且在组件之前被植入且在已植入的骨螺钉1之间绳被预张紧。在其它实施方式中,可将松散地组装的连接件设置成接触植入的骨螺钉1并位于植入的骨螺钉1之间,其中固定螺钉312与绳306接合足以防止元件从绳306的一端滑落。然而,在该组件中,绳306还没被张紧且因此各构件将沿着绳分散,且绳的长度使得在组件被固定至骨螺钉1之后该绳可被抓握并张紧。
接着通过将各套管304插入骨螺钉1之一中而将连接件构件组件植入。套管304被顶部加载穿过接收件开口66,其中内弯曲表面355对齐臂边缘表面71并沿着其滑动,直到套管304坐靠在插件14上,且套管突起344与插件臂顶部表面165接合。接着将封闭顶部18或18”插入并在骨螺钉接收件10的臂之间前进,从而偏置或推靠各套管304。驱动工具(未示出)被插入在各封闭件驱动部中,以旋转并驱动各封闭件顶部18或18”至各自接收件10中,封闭件顶部的下表面接合并向下按压套筒304的顶本体表面340。如图58中所示,当使用封闭件顶部18时,底突缘190刺入顶部本体表面340中,但是封闭件不与套管孔336中设置的绳306接合。如图58和61中所示,封闭件顶部18或18”至套管304上的向下移动进而将套筒304按压至与插件14接合,其进而向下按压杆头部8,将头部8锁在插件14与保持件12之间,保持件12向外压靠接收件10。由于插件14是锁定和释放插件,所以插件14现在是在表面95楔靠接收件,骨螺钉组件1的多轴机构现也被锁定,即使封闭顶部18或18”被松开并从套管表面340旋开。
接着可将本领域已知的张紧工具(未示出)用于牵引并施加张力于绳306上。应注意如果将多于一个的抓握封闭件顶部18”用于连接件的每一端,则可初始地锁定一个顶部,且接着在张紧之后可锁定其它的顶部,或者可选地,进行多于一个的张紧步骤。优选地,缓冲器314和端阻断器310被用于至少一端,且绳306优选地被张紧直到缓冲器314压缩,且然后使用与螺钉312的内驱动部接合的驱动工具(未示出)将固定螺钉312旋转并驱动进入阻断器310且抵靠绳306。阻断器310有利地包括相反的槽(或者在一些实施方式中的平坦侧面),从而允许在张紧过程中设置用于保持阻断器的反转矩工具并将绳306固定在阻断器中。如在美国专利申请号第12/802,849中所说明的,固定螺钉312和阻断器310组合优选地包括有限的移动特征,使得固定螺钉被锁定在牢固地保持但不损坏绳306的位置。最后该绳306被修剪至接近连接件的各端的期望长度。
因此连接件组件基本动态地加载并相对于配合脊椎定向,提供了缓解(如,减震),以及关于施加在组件和连接的骨螺钉1上的弯曲、延伸、牵张和压缩力的保护移动。在根据本发明的连接构件的一些实施方式中,如果需要,可将套管和柱组合用于组件的一端(或者两端)以提供硬的、非弹性长形部分,用于连接至另外的骨螺钉或多个螺钉,从而提供具有动态弹性部以及较长的刚性非弹性部的连接构件。
最后,如果脊柱需要更加刚性的支撑,可将该连接构件组件移除并以另一个纵向连接构件(如稳固(solid)的柱或条)替换,例如该构件具有与套筒304的本体部分相同的宽度或直径,使用相同的接收件10和相同或相似的封闭结构18。可选地,如果最终需要较少的支撑,则使用较低刚性的、更柔性的组件,例如,具有以比被替换的垫片和缓冲器更软和更易压缩的材料制成的间隔器316和缓冲器314的组件,也使用相同的骨螺钉1和封闭件18”以及封闭件18。
参考图63-74,示出了可选的套管305,具有骨螺钉组件1,滑动18和抓握18”封闭顶部的,且还具有可选的间隔器316’。套管305基本与套管304相似,除了套管305具有基本矩形形状的相反法兰438而不是具有由部分圆柱形表面346和平坦表面348限定的部分圆形形状的法兰。具体地,套管法兰438具有顶平坦表面446,相反的平坦前和后表面447,以及外平坦端表面448,该外平坦端表面448用于邻靠间隔器316或316’和缓冲器314。另外地,套管305包括本体434、通孔436、本体顶部440、本体圆柱底表面441、本体下平坦表面442、突起部分444、法兰底表面450、弯曲过渡表面451、过渡法兰表面452、内相对朝向表面453、凹进或杯形表面455、上内圆柱表面456和横向孔460,这些在形式和功能方面与这里前述的插件304的各自本体334、通孔336、本体顶部340、本体圆柱底表面341、本体下平坦表面342、突起部分344、法兰底表面350、弯曲过渡表面351、过渡法兰表面352、内相对朝向表面353、凹进或杯形表面355、上内圆柱表面356和横向孔360相似。该基本矩形法兰438提供了低外形的套管,其中顶表面446被方便地设置以与一些间隔器配合从而提供转矩控制,该间隔器如图71-74中所示的间隔器316’。该间隔器316’是椭圆或卵形形状,包括其中形成有压缩槽491的弯曲外表面490,中间孔492,相反的平坦端表面494,和大体以496指示的位于椭圆的窄的部分的上悬伸部分或唇缘,该唇缘496还具有平坦端表面497和平坦底表面或突出部498。如图71和72中所示,突出部表面498被尺寸设置和成形以与套管法兰438的顶表面446接合,其中唇缘端表面497与接收件10臂表面相邻,向整个组件提供了一些转矩控制。间隔器316’的窄外形改进了所得到的组件的低外形,且还提供了在弯曲和延伸的改进。应注意,在手术过程中,需要由外科人员将间隔器316’在与压缩槽491相反的侧切割为期望的长度,这与关于间隔器316所述的相似。为此,使用特殊的夹具(未示出)切割间隔器,以在刚切割的侧上包括悬伸唇缘496。
参考图75-106,附图标记1001大体表示根据本发明的可选的、多轴骨螺钉设备或组件。组件1001包括杆1004;接收件1010;摩擦配合保持件1012;和皇冠式压缩或压力插件1014。在组件1001和组件1之间有很多相似。实施方式1与1001之间的不同主要在于保持件1012由转动过程制成,例如,允许更多的圆弧表面,其在内柄脚和杆头部1008之间提供改进的摩擦配合。在外侧柄脚上的脊或者其它高摩擦系数处理提供了在装配的某些阶段与接收件的改进的抓握。此外,如下文中将更具体地说明,保持件1012包括另一的下外层或者裙部,其与允许更低的外形的接收件配合,将保持件(且因此配合杆头部)落在接收件中比图1中所示的组件1更低的位置处。正如组件1,接收件1010、保持件1012和压缩插件1014被初始地装配,且还可在将杆本体1006植入脊椎17之前或之后进一步与杆1004装配,与这里之前所说明的组件1相似,且还将在下文中进一步说明。例如,图75和99还示出用于捕获长形连接构件的封闭结构1018,该长形连接构件如柱1021,其进而与压缩插件1014接合,该压缩插件1014将杆头部1008压靠至与保持件1012固定地摩擦接触,从而将长形连接构件1021捕获和固定在接收件1010中,且因此将构件1021相对于脊椎17固定。与这里之前所说明的组件1基本相似,接收件1010和杆1004的配合方式使得接收件1010和杆1004可相对于彼此被固定在多个角度、铰连接位置或者旋转对准位置的任何一个,并且在从左至右和从前至后的选定角度范围内,以使接收件1010与杆1004能挠性或铰接接合,直到在植入手术接近结束时该二者被彼此锁定或固定。该示出的封闭顶部1018和柱1021在形式和功能上基本分别与这里之前相对于组件1所说明的封闭顶部18和柱21相似,且因此不在本部分进行重复说明。
杆1004还基本上在形式、功能和材料上与这里之前说明的杆4相似。因此,杆1004具有本体1006,头部1008,杆螺纹1024,颈部1026,末端1028,螺纹1024终止的杆本体顶部1032,头部球形表面1034,头部顶边缘1038,头部上截头圆锥表面1039,内驱动部1046和中空孔1050(未示出),这些与这里之前关于组件1的杆4说明的以下各自元件相同或基本相似,杆本体6,头部8,杆螺纹24,颈部26,末端28,杆本体顶部32,头部球形表面34,头部顶边缘38,头部上截头圆锥表面39,内驱动部46和孔50。与杆4的头部半球40相似,所示的杆头部1008具有由虚线1040指示的半球位置。
具体地参考图75-79,接收件1010在形式、功能和材料上还与这里之前说明的接收件10基本相似。然而,在接收件10和接收件1010之间具有一些不同,包括延伸通过接收件1010的底座1060的间隔开的孔1056,以及关于其它孔和限定接收件1010的大体以1061指示的腔体的内表面的一些几何形状的改变,这些将在下文中详细描述。首先,关于两个接收件之间的相似处,接收件1010包括接收件底座1060的外弯曲表面1058和外平坦表面1059,相对的臂1062,臂1062之间的插入表面1063,具有上开口1066和座1068的U形通道1064,在以1070指示的大体圆柱内壁表面的每侧上的臂内平坦表面1069,引导和前进结构1072,臂顶表面1073,外圆形孔1074,外圆柱臂表面1076,相对的通孔1077,相对的保持凸片1078,凸片倾斜外表面1080和1081,凸片顶表面1082,凸片插件接合表面1084,凸片下表面1085,凸片内下倾斜表面1086,凸片内圆柱表面1087,凸片侧表面1088,孔1077的顶表面1089,孔1077的侧表面1090和孔1077的U形底表面1091,这些与这里上文中关于接收件10说明的以下元件相同或基本相似:接收件底座60的各自外弯曲表面58和外平坦表面59,相对的臂62,臂62之间的插入表面63,具有上开口66和座68的U形通道64,臂内平坦表面69,总体以70指示的圆柱内壁表面,引导和前进结构72,臂顶表面73,外圆形孔74,外圆柱臂表面76,相对的通孔77,相对的保持凸片78,凸片倾斜外表面80和81,凸片顶表面82,凸片插件接合表面84,凸片下表面85,凸片内下倾斜表面86,凸片内圆柱表面87,凸片侧表面88,限定孔77的顶表面89,限定孔77的侧表面90,和限定孔1077的U形底表面91。然而,U形底表面1091被设置在接收件1010中的位置比接收件10的底表面91更低。U形底表面1091大体与通孔1056对齐且与其间隔开,弯曲底表面1091和限定孔1056的下表面各大体距接收件底表面1108相同的距离,允许接受工具(未示出)穿过其中,在将保持件与其它骨螺钉部件装配的过程中工具用于均匀地和相等地向内按压保持件1012的外柄脚,如下文中将更具体说明。
进一步参考接收件内腔体1061,其与接收件10的腔体61基本相似但不完全相同,其中位于引导和前进结构1072直接下方的臂内圆柱表面1092与位于接收件10的引导和前进结构72下方的表面92相似。接收件1010还具有径向向内设置的内圆柱表面1095,其与接收件10的表面95相似。如表面95,表面1095被尺寸设置和成形以用于与插件1015锁定干涉配合。如表面95,表面1095限定接收件底座1060的上部分,且还与腔室顶表面1096相邻。然而,接收件10表面92被设置成紧接于表面95,而在接收件1010中,彼此直径稍稍不同的其它圆柱表面被设置在表面1095和表面1092之间,即,它们是圆柱表面1093和1094。阶梯表面1094’与接收件10的表面94相同或相似。与接收件10不同,限定接收件腔室或腔体的上表面1096径向向外延伸至圆柱表面1098。接收件1010不包括与接收件表面97的等同物。接收件腔体1061的其余部分基本与腔室61实质性相似,接收件腔体1061由扩展腔室表面1098限定,且限定保持件1012的座的表面包括圆柱表面1100和1101,环形座1102和1103,过渡阶梯表面1104,圆形突缘或边缘1106,截头圆锥表面1107,底座底表面1108和下开口1110,其在形式和功能上与这里上文中说明的接收件10的以下元件分别相同或相似:圆柱表面98,限定保持件12的座的表面,其包括圆柱表面100和101,环形座102和103,过渡阶梯表面104,圆形突缘或边缘106,截头圆锥或扩张表面107,底座底表面108和下开口110。
具体地参考图75和80-86,示出了下开口或切口摩擦配合保持件1012,其操作以将杆上部分1008捕获在接收件1010中。在装配和操作的一些阶段,保持件1012被部分地限制在接收件中,在表面1096下方的位置处被捕获在接收件腔体1061中,保持件1012可相对于接收件旋转,但不相对于其枢转,且一旦向下部署进入接收件腔体1061中则不能容易地从接收件移出。保持件1012具有中心轴线,当杆上部分1008与保持件1012被安装在接收件1010中时保持件1012的中心轴线在可操作地与关于接收件1010的中心轴线相同。保持件1012包括具有外表面1116的本体1115,直立内板或柄脚1117和直立外板1118,其在形式和功能上与前述关于组件1说明的具有外表面116、内117和外118板的保持件本体115相似但不完全相同。与保持件12相比,保持件1012外本体表面1116是仅被保持件切口1148断开的外圆柱体。此外,内和外保持件柄脚以与保持件112(机械转动或旋转处理)不同的方式形成,提供更多的圆弧表面。其中有三个内板117和六个外板118。然而,可预见可具有更少或更多数量的内和外板。
与保持件12下裙部121相似,保持件1012包括下外圆柱裙部或表面1121,其被设置在板1118下方。保持件1012还包括另外的下或底裙部1121’,其是截头圆锥的形式,且向下和径向向内地延伸至底表面1122。保持件1012还包括内板外表面1128,内板圆弧表面1129,内板顶表面1130,外板表面1132,外板内表面1133和外板顶表面1134,这些在形式和功能上分别基本与这里上文中关于保持件12描述的以下元件相似:内板外表面128,内板圆弧表面129,内板顶表面130,外板外表面132,外板内表面133和外板顶表面134。具体地参考图81,保持件1012还包括设置在板外表面1132上的脊1135,用于在装配过程中与接收件表面1095暂时地摩擦接合,下文中将更详细地描述。可预见脊1135由其它类型的表面处理替换,以提供在保持件和接收件之间的增大的摩擦系数,例如压花或者其它粗化表面处理。
保持件1012具有大体以1141指示的中心通道,内截头圆锥表面1143,内圆柱表面1145,具有边缘1147的内阶梯表面1146,大体以1148指示的切口,弯曲的杯形表面1149,以及限定切口1148的第一和第二表面1152和1153,其在形式和功能上分别与各自中间通道141,内截头圆锥表面143,内圆柱表面145,具有边缘147的内阶梯表面146,大体以148指示的切口,弯曲的杯形表面149,以及限定切口148的第一和第二表面152和153相同或相似。与保持件12不同,由于下裙部1121’,杆接合边缘1146和杯形表面1149被设置成在保持件1012的内杆最终接合和锁定机构中比保持件12的边缘147和杯形表面149更低,提供了更好的和改进的多轴移动的组件。
如保持件12,保持件1012由弹性材料制成,如不锈钢或钛合金,从而在装配的多个步骤过程中保持件本体1115可扩展而保持件的凸片或板1117和1118可被操作,如下文中将更具体地说明。半限制保持件1012相对于接收件1010的旋转性允许保持件相对于杆的操作和设置,以得到在外科医生期望的位置处的增大的铰接角度。
参考图75和87-89,示出了锁定压缩插件1014,其被尺寸设置和成形以在上开口1066处被向下载入接收在接收件1010中。因此,压缩插件1014与本文中之前说明的插件14基本相似,除了指示各零件的附图标记不同,因此这里不再进一步说明。因此,插件1014包括本体1156,臂1157,圆柱本体表面1158,干涉配合表面1159,臂外表面1160,下圆柱表面1161,倾斜突出部过渡表面1162,平坦底部1164,臂顶部表面1165,通孔1167,浅孔1168,槽1170,通孔1171,U形通道或鞍形部1173,鞍形座1174,内圆柱表面1176,下圆弧表面1178,和杆抓握部分1180,其在形式,功能和材料上分别与本文中之前说明的插件14的以下元件相同或基本相似:本体156,臂157,圆柱本体表面158,干涉配合表面159,臂外表面160,下圆柱表面161,倾斜突出部过渡表面162,平坦底部164,臂顶部表面165,通孔167,浅孔168,槽170,通孔171,鞍形部173,鞍形座174,内圆柱表面176,下圆弧表面178,和杆抓握部分180。
图90-94中示出了接收件1010,保持件1012和压缩插件1014的预装配。具体地参考图90,首先将保持件1012插入上接收件开口1066中,以外板1118前导,其中板1118顶表面1134朝向一个臂1062,且保持件底表面1122朝向相对臂1062。接着保持件1012以侧向方式向下进入通道1064,且部分地进入接收件腔体1061,随后倾斜该保持件1012,使得至少一个板顶表面1134位于接收件保持凸片1078之一的表面1085下方,且相对的保持凸片1078大体被设置在一对板1118之间,例如在保持件切口1148处或其附近处,如图91中所示。然后,参考图91,保持件1012被倾斜至一位置,其中保持件1012的中心轴线大体与接收件中心轴线对齐,且接收件保持凸片1078各自设置在相邻板1118对之间并在彼此相反地设置的保持件本体顶表面1126上方延伸,其中各凸片表面1085被设置在顶表面1126或切口1148直接上方。图91还示出了处于压缩状态的保持件1012,其中切口表面1152和1153处于接近接触状态,从而保持件圆柱表面滑动经过接收件内表面1095。
参考图92,在将板1118设置在保持凸片1078之间后,保持件1012下降进入接收件腔体1061,其中弹性板1118通过工具或者通过向下力被向内按压,该向下力使得板1118朝向接收件中心轴线被压缩。参考图93,保持件1012被按压经过接收件表面1095并允许“展开”,柄脚1118在落入主要由圆柱表面1098限定的腔体之后伸展至中性或接近中性状态,外柄脚1118位于表面1096下方,将保持件1012捕获在接收件腔体1061中。参考图93和94,这时,插件1014落入接收件通道1064中,且接着以与本文之前关于插件14和接收件10说明的方式相同的方式而旋转到位。接着,如图94中所示,将工具(未示出)插入穿过接收件孔1056,且位于孔1077的U形表面1091上方,以向内按压保持件柄脚1118,且接着如图95中所示,保持件1012在腔体1061中向上移动。该工具被释放,且具有脊1135的保持件柄脚外表面邻靠接收件表面1095且与其摩擦接合。现保持件1012被捕获在表面1095之间,并位于接收件1010中的期望空间处,用于运输和与杆1004的进一步装配。插件1014还通过引导和前进结构1072和位于插件下方的保持件1012而被完全捕获在接收件1010中,引导和前进结构1072防止插件1014向上和向外移动通过接收件开口1066。
参考图95,预装配的接收件、插件和保持件被设置在杆上部分1008上方,直到杆上部分被接收在开口1110中。具体地参考图95-98,随着杆上部分1008移动进入接收件底座的内部1061中,杆上部分1008被向上压靠在接收件凹部中的保持件1012上,该接收件凹部部分地由圆柱表面1098限定。随着杆头部1008继续向上朝向通道1064移动,杆头部表面1034将保持件1012推靠在插件1014上。然而,通过接收件引导和前进结构1072阻止插件1014向上移动。因此,向上移动的杆头部1008推动保持件切口1148扩张以及保持件1012的本体1115朝向接收件圆柱表面1098,1100和1101的相应向外移动,接收件圆柱表面1098,1100和1101限定接收件膨胀凹部或腔室,最佳地如图96中所示,而接近其顶表面1134的保持件柄腿1118大体被保持在直接位于插件1014底表面1164下方的位置处。这时,头部1008的球形表面1034与保持件内圆柱本体1145和边缘1147接触。参考图97,随着杆头部1008的球形的中间越过保持件表面1147,保持件1012开始朝向中性或标称位置返回。在球形表面1034的半球延伸进入位于保持件中间通道1141中的期望捕获位置时,杆表面1034与边缘1147接触以及与内板1117在表面1129处接触。突缘或边缘1147表面接触和板1117表面1129接触的组合弹性地压靠圆弧表面1034,提供了在头部1008和保持件1012之间的非常紧密的摩擦配合,表面1034可通过一定力关于保持件1012枢转。因此,在保持件1012和杆上部分1008之间形成紧密的、非宽松球窝接头。
参考图98,接着将接收件向上拉,或者接着将杆1004和连接的保持件1012手动向下移动至一位置,其中保持件板1118从接收件表面1095松开,允许板1118弹性地释放和向外延伸进入中性或接近中性位置,其在限定接收件内腔室1061的顶部的接收件环形表面1096下方。板1118现被捕获在接收件和保持件中,其中任何向上移动导致板顶表面1134邻靠接收件表面表面1096。然而,尽管完全捕获,由于使用者能够在将杆1004相对于接收件1010锁定之前将保持件1012关于接收件1010中心轴线旋转,所以保持件/杆组合有利地仅部分地相对于接收件被限制。此外这时,保持件完全坐靠在接收件表面1102和1103上,且表面1116和1121被向外压至与接收件成邻接关系,其中下裙部1121’从接收件扩张表面1107间隔开,且保持件底表面1122大体与接收件底表面1108处于相同的平面中。参考图100,杆头部1008作用在保持件边缘1147上的向下压力进一步将保持件本体1115向外扩张,部分地由下裙部表面1121和1121’形成的保持件本体有利地允许头部1008位于接收件中的位置比在其它已知多轴骨锚以及比在组件1中所示的位置更低。因此,裙部特征允许更加稳定的较低坐靠表面,结合允许杆相对于保持件(且因此相对于整个骨螺钉组件)的增加的角度方向的保持件杯形表面1149,该角度可增加而不需要在接收件底部1108或接近其的位置处提供切开或杯形表面。另外有利的是可将部分被限制的保持件1012相对于接收件1010关于接收件中心轴线旋转,允许使用者选择在接收件1010和杆1004之间的增加的角度方向的位置。
参考图98,在保持件1012向下移动进入接收件1010并位于表面1102和1103上之后,由于接收件弹簧凸片1078和/或接收件阶梯表面1094阻止插件1014的向下移动,插件1014保持在杆头部1008上方与其间隔开地设置,除非通过工具或者柱1021以及如图99中所示的封闭顶部1018将向下力施加在插件上,例如本文中之前关于基本相同的锁定插件1014说明的。这时,在与封闭顶部锁定之前,接收件1010可枢转至关于相对于杆4的期望角度位置(例如,图101和102中所示的角度方向),其可由保持件1012内板1117和杆上部分1008之间的摩擦接合保持但不锁定。如上文中关于组件1所说明的,这时,可通过工具或者封闭顶部1018向下按压在柱1021上,其进而向下按压插件1014而将锁定和释放插件1014按压至与接收件表面1095成干涉配合关系,如图99和100中所示。该组件1001可配套与上文中关于组件1所说明的可变形柱和配合封闭件。该插件1014还可如上关于组件1所述地解锁。
参考图101-103,示出了杆1004关于接收件1010的不同角度或铰接位置,一些完全利用了保持件1112的切口1148和相邻的切开或杯形表面1149。例如,在图102中,杆1008朝向杯形表面1149枢转并与其接合(约三十度铰接角度),而在与之对比的如图101所示布置中,杆1004以与保持件切口1148和表面1149相反的方向枢转(约二十度铰接角度)。
图103示出了可选的接收件1010’,其包括进一步由一对相对的、阶梯形的和凹进的弯曲底表面1109’限定的底表面1108’。另外地,接收件1010’与上述接收件1010相同,且因此完全与保持件1012、插件1014、杆1004、柱1021和封闭顶部1018以与前述关于组件1001基本相同的方式配合。图103示出了安装在接收件1010’中的保持件1012,其中保持件切口1148和表面1149与阶梯表面1109’中的一个对齐,该对齐提供了在杆1004与接收件1010’之间的至少四十度的铰接角度。
参考图104-106,示出了用于本文中之前说明的杆1004、接收件1010、保持件1012、封闭顶部1018和柱1021的可选的非锁定压缩插件1014’。插件1014’基本与本文中之前说明的非锁定插件214相似。在与接收件的装配过程中,插件1014’旋转且接收件保持凸片表面1084沿着槽1070’滑动直到其弹入孔1066’中,该孔1066’具有条1067’其与这里之前关于插件214说明的孔和条267相同或相似。该条1067’将非锁定插件1014’在保持件1012上方保持到位,直到被设置成通过来自柱1021和封闭顶部1018的压力而与杆头部1008锁定接合。
参考图107-137,附图标记2001大体表示根据本发明的另一个可选多轴骨螺钉设备或者组件。该组件2001包括杆2004;接收件2010;摩擦配合保持件2012;和皇冠形压缩或压力插件2014。在组件2001和组件1以及1001之间有很多相似处。然而,组件2001与组件1001和组件1的区别在于保持件2012是怎样在接收件2010中展开的,这还改变杆2004是怎样整体“套”入机构。该区别主要涉及特定接收件2010表面关于保持件2012的尺寸,从而提供用于保持件的邻接表面,从而得到在保持件2012和接收件2010之间的相应干涉配合。此外,在杆2004的头部2008上的脊或其它高摩擦系数处理提供了在一些装配步骤中杆2004和保持件2012之间的抓握。如保持件1012,保持件2012包括另外的下外层或裙部,其与接收件2010配合允许低的外形,这与本文中之前说明的组件1001相似。例如,图107、130和131还示出了用于捕获长形连接元件的封闭结构2018,例如柱2021,柱2021进而接合压缩插件2014,其将杆头2008压靠至与保持件2012固定地摩擦接触,从而将长形连接元件2021捕获并固定在接收件2010中,且因此将构件2021相对于脊椎17固定。与这里之前说明的组件1和1001基本相似,接收件2010和杆2004的配合方式使得接收件2010和杆2004可以被固定在相对于彼此的多个角度、铰接位置或者旋转对准位置中的任何一个,并且在从左至右和从前至后的选定角度范围内,以使得接收件2010与杆2004能挠性或铰接接合直到在植入程序的接近结束时该二者被彼此锁定或固定。该所示的封闭顶部2018和柱2021在形式和功能上与本文中之前关于组件1说明的各自封闭顶部18和柱21是相同的或基本相似的,且因此不在本部分重复说明。此外,图132示出了可选的可变形柱2021’和配合封闭顶部2018’,其与本文中之前说明的各自可变形柱21’和封闭顶部18’相同或基本相似。
杆2004在形式、功能和材料上基本本文中与之前说明的杆4相似。因此,杆2004具有本体2006、头部2008、杆螺纹2024、颈部2026、末端2028、螺纹2024终止的杆本体顶部2032、头部球形表面2034、头部顶边缘2038、头部上截头圆锥表面2039、内部驱动部2046和中空孔2050,其与本文中之前关于组件1说明的以下各自元件相同或基本相似,杆本体6、头部8、杆螺纹24、颈部26、末端28、杆本体顶部32、头部球形表面34、头部顶边缘38、头部上截头圆锥表面39、内部驱动部46和孔50。此外,在直接位于头部2008的半球下方的位置处,杆表面2034包括多个平行的脊2035,围绕头部2008延伸并且与圆杆顶部边缘2038的平面平行。该脊2035有助于在所示的一些装配步骤过程中帮助保持件抓握杆头部2008,例如如图127和128中所示以及在下文中更具体地说明。
具体地参考图109-111,接收件2010在形式、功能和材料上基本与本文中之前说明的接收件1010和10相似。然而,在接收件2010和接收件1010之间存在一些不同,接收件2010不包括间隔开的孔1056,而是另外地包括下文中将具体说明的座表面,其提供在一些装配步骤中用于将保持件2012保持在期望位置处的止挡部以及稍后保持件2012与接收件2010之间的干涉类型配合。首先,关于接收件之间的相似处,接收件2010包括接收件底座2060的外弯曲表面2058和外平坦表面2059,相对的臂2062,在臂2062之间的插入表面2063,具有上开口2066和座2068的U形通道2064,在以2070指示的大体圆柱内壁表面的每一侧上的臂内平坦表面2069,引导和前进结构2072,臂顶表面2073,外圆形孔2074,外圆柱臂表面2076,相对的通孔2077,相对的保持凸片2078,凸片倾斜外表面2080和2081,凸片顶表面2082,凸片插件接合表面2084,凸片下表面2085,凸片内下倾斜表面2086,凸片内圆柱表面2087,凸片侧表面2088,孔2077的顶表面2089,孔2077的侧表面2090,和孔2077的U形底表面2091,其与本文中之前关于接收件10所说明的以下各自元件相同或基本相似,接收件底座60的外弯曲表面58和外平坦表面59,相对的臂62,在臂62之间的插入表面63,具有上开口66和座68的U形通道64,臂内平坦表面69,以70指示的大体圆柱内壁表面,引导和前进结构72,臂顶表面73,外圆形孔74,外圆柱臂表面76,相对的通孔77,相对的保持凸片78,凸片倾斜外表面80和81,凸片顶表面82,凸片插件接合表面84,凸片下表面85,凸片内下倾斜表面86,凸片内圆柱表面87,凸片侧表面88,限定孔77的顶表面89,限定孔77的侧表面90,和限定孔1077的U形底表面91。
进一步参考大体以2070指示的接收件内臂表面,和腔体2061,该表面特征基本上与组件1001的内臂表面1070和限定腔体1061的表面相似,但与其不完全相同。因此,关于相似性,接收件2010包括内臂表面2092、2093和2094,以及台阶表面2094’,其在形式和功能上与本文中之前关于接收件1010所说明的各臂表面1092、1093、1094,以及台阶表面1094’相同。此外,关于限定接收件腔体2061的表面,接收件2010包括圆柱表面2095,腔室顶表面2096,圆柱扩展腔室表面2098,其在形式和功能上与接收件1010的以下元件相同或基本相似,圆柱表面1095,腔室顶表面1096,和圆柱表面1098。
关于限定腔室2061的保持件最终座部分的表面,该接收件2010包括下圆柱表面2101,环形座表面2102和2103,下边缘2106,扩张表面2107,底座底表面2108和下开口2110,其与接收件1010的以下元件分别相同或基本相似,下圆柱表面1101,环形座表面1102和1103,下边缘1106,张开或截头圆锥表面1107,底座底表面1108和下开口1110。具体地参考图111,尽管与圆柱表面1101相似,位于环形表面2102和过渡台阶2104之间的接收件2010表面与表面1104不同。过渡台阶2104还与接收件1010的过渡台阶1104稍稍不同。在该接收件2010中,倾斜过渡台阶2104比台阶1104进一步径向向内延伸,提供了台阶边缘2105和相邻的斜面的或倾斜的表面2105’,其用作用于保持件2012的止挡(参见图122),除非和直到保持件2012被推至与边缘2105紧密配合接合,要求力将保持件2012推动超过边缘2105,如图128和129中所示且在下文中将详细说明。表面2100不是与接收件2101的中心轴线2010平行,而是稍稍向外朝向接收件底座表面2058成角度。因此,与表面1100与表面1102垂直的接收件1010不同,在接收件2010中,表面2100相对于表面2102成锐角,虽然仅稍稍小于九十度。表面2100的该稍微倾斜使得当将保持件2012移动经过边缘2105且接着向下至与环形座表面2102和2103邻接时有一定间隙和更容易。
具体地参考图107和112-116,示出了下开口或切口摩擦配合保持件2012,其操作以将杆上部分2008捕获在接收件2010中。与保持件12和1012不同,在与杆2004装配的所有阶段,且在后继的操作中,保持件2012部分地限制在接收件中,在表面2096下方的位置处被捕获在接收件腔体2061中,该保持件1012可相对于接收件旋转,但不关于其枢转,且一旦向下展开进入接收件腔体2061中则不能容易地从接收件移出。该保持件2012具有中心轴线,当杆上部分2008和保持件2012被安装在接收件2010中时,该中心轴线在操作上与接收件2010相关的中心轴线相同。该保持件2012包括本体2115,其具有外圆柱表面2116,直立内板或柄脚2117,和直立外板2118,其与本文中之前关于组件1001说明的以下元件分别基本相似,本体1115,外表面1116,内柄脚1117和外柄脚1118。然而,由于在运输和与杆2008的装配过程中保持件2012柄脚2118没有接收件被向内按压,所以外柄脚2118不包括外脊或其他表面处理。该内柄脚2117还稍与柄脚1117不同,其中内圆弧表面2129不具有如内表面1129那么多的表面区域。表面2129的尺寸大体上与杆脊2035的尺寸相应,在杆头部2008与圆弧表面2129之间提供了最佳的抓握,用于在将组件2001的多轴机构锁定之前杆2004关于接收件2010的操作过程中的期望摩擦配合。正如保持件1012,该保持件2012包括三个内板2117和六个外板2118。然而,可预见,可具有更少或更多数量的内和外板。
保持件2012包括圆柱下裙部2121,截头圆锥底裙部2121’和底表面2122,其与本文之前关于保持件1012说明的以下元件分别基本相同或相似,裙部特征1121和1121’,以及底表面1122。在外圆柱表面2116与裙部2121之间的是连接的基本环形表面2124。在裙部2121和底裙部2121’之间的是连接基本平坦环形表面2125。在所示的一些装配步骤中,表面2124邻靠接收件边缘2105,如图122中所示。
保持件2012的其它特征包括柄脚2117外表面2128,内圆弧表面2129,顶表面2130,柄脚2118外表面2132,内表面2133和顶表面2134,其与保持件1012柄脚1117外表面1128,内圆弧表面1129,顶表面1130,柄脚1118外表面1132,内表面1133和顶表面1134分别相似。如上所述,内柄脚圆弧表面2129与柄脚表面1129在表面区域方面不同,但是另外功能相似,以在杆相对于保持件操作的过程中提供摩擦配合。该保持件2012还包括中间通道2141,内截头圆锥表面2143,内圆柱表面2145,台阶表面2146和内杆抓握边缘2147,切口2148,杯形或切开表面2149和限定切口2148的表面2152和2153,其与这里之前说明的保持件1012的以下元件分别相同或基本相似,中间通道1141,内截头圆锥表面1143,内圆柱表面1145,台阶表面1146,和内杆抓握边缘1147,切口1148,杯形或切开表面1149和限定切口1148的表面1152和1153。
具体地参考图107和117-118,示出了锁定压缩插件2014,其被尺寸设置和成形以在上开口2066处被接收并向下载入接收件2010中。该压缩插件2014还与这里之前说明的插件14和1014基本相似,除了指示各特征的附图标记不同,这里将不再说明。因此,插件2014包括本体2156,臂2157,圆柱本体表面2158,干涉配合表面2159,臂外表面2160,下圆柱表面2161,倾斜突出部过渡表面2162,平坦底部2164,臂顶表面2165,通孔2167,浅孔2168,槽2170,通孔2171,U形通道或鞍形部2173,鞍形座2174,内圆柱表面2176,下圆弧表面2178,和杆抓握部分2180,其在形式、功能和材料上与这里之前关于插件14说明的以下元件分别相同或基本相似,本体156,臂157,圆柱本体部分158,干涉配合表面159,臂外表面160,下圆柱表面161,倾斜突出部过渡表面162,平坦底部164,臂顶表面165,通孔167,浅孔168,槽170,通孔171,鞍形部173,鞍形座174,内圆柱表面176,下圆弧表面178,和杆抓握部分180。
在图119-124中示出了接收件2010、保持件2012和压缩插件2014的预装配。具体地参考图119,首先将保持件2012插入上接收件开口2066中,以外板2118为前导,其中板2118顶表面2134朝向一个臂2062,而保持件底表面2122朝向相反臂2062。接着保持件2012以侧向方式向下进入通道2064,且部分地进入接收件腔体2061,随后倾斜该保持件2012,使得至少一个板顶表面2134位于接收件保持凸片2078中的一个的表面2085下方,且相反的保持凸片2078大体位于一对板2118之间,例如在图120中所示的保持件切口2148处或其附近处。然后,保持件2012被倾斜至一位置,其中保持件2012的中心轴线大体与接收件中心轴线对齐,且接收件保持凸片2078各设置在相邻板2118对之间并在彼此相反地设置的保持件本体顶表面2126上方延伸,其中各凸片表面2085被直接设置在顶表面2126或切口2148上方。图120还示出了处于压缩状态的保持件2012,其中切口2148表面2152和2153处于接近接触状态,从而保持件圆柱表面滑动经过接收件内表面2095。
在将板2118设置在保持凸片2078之间后,保持件2012下降进入接收件腔体2061,其中弹性板2118通过工具或者通过向下力被向内按压,该向下力导致板2118被朝向接收件中心轴线压缩。参考图121,保持件2012被按压超过接收件表面2095并允许“展开(deploy)”,柄脚2118在落入主要由圆柱表面2098限定的腔体之后伸展,外柄脚2118位于表面2096下方,将保持件2012捕获接收件腔体2061中。参考图122,这时,阻止保持件2012移动进入在接收件腔体2061的下部分中的完全坐靠位置。边缘2105和相邻表面2105’提供了邻靠止挡,其中保持件环形表面2124暂时地坐靠在其上。要求向下力以将保持件2012移动至与接收件表面2102和2103的完全坐靠位置。因此,这时,由于柄脚2118的向外展开,有利地防止了保持件向下移动通过边缘2105或者向上移动通过表面2096。参考图123,这时插件2014落入接收件通道2064中,且接着以与之前关于插件14和接收件10说明的方式相同的方式而旋转到位(参见图124)。现在,插件1014还通过引导和前进结构2072以及通过位于插件下方的捕获的保持件2012而被完全捕获在接收件2010中,该引导和前进结构2072防止插件1014向上和向外移动通过接收件开口2066。
参考图124,示出了用于运输和还用于连接至杆2004的预装配的接收件、插件和保持件。该预装配组件被设置在杆上部分2008上方,直到杆上部分2008被接收在开口2110中。具体地参考图125-128,随着杆上部分2008移动进入接收件底座的内部2061中,杆上部分2008被向上压靠在接收件凹部中的保持件2012上,该接收件凹部部分地由圆柱表面2098以及圆柱表面2100和2101限定,最佳地在图125中示出(示出了最大扩张)。通过邻靠顶表面2096的外柄脚2118阻止了保持件2012的继续向上移动。参考图126,随着杆头部2008继续向上朝向通道2064移动,杆头部表面2034最终邻靠在插件2014上。然而,通过接收件引导和前进结构2072阻止插件2014向上移动。此外,还参考图126和127,这时,杆头部球形表面2034在脊2035处与保持件内柄臂2117的圆弧表面2129抓握接触,且随着杆头部2008的球形的中间通过保持件表面2147,保持件2012开始朝向中性或标称状态返回。参考图128,示出的杆2004处于向下拉的初始状态,其中圆弧表面2129非常牢固地抓握带脊表面部分2035。参考图129,将杆2004继续从接收件2010向下拉,将保持件2116拉动通过接收件邻接边缘2105,且接着保持件被设置在完全坐靠位置,其中保持件表面2124和2125完全邻靠和坐靠在接收件表面2102和2103上。该圆弧表面2129仍然与带脊表面2035摩擦接触,在头部2008和保持件2012之间提供非常紧密的摩擦配合,表面2034通过一定力关于保持件2012枢转。因此,在保持件2012和杆上部分2008之间形成紧密的、非宽松球窝接头。尽管仍然被完全捕获在接收件中,外柄脚或板2118仍然部分地相对于接收件被限制,因为在将杆相对于接收件锁定之前使用者能将保持件关于接收件中心轴线旋转。因此,这时,保持件完全坐靠在接收件表面2102和2103上,且表面2116和2121被向下按压至与接收件成邻接关系,其中下裙部2121’与接收件张开表面2107间隔开,且保持件底表面2122与接收件底表面2108大体在相同平面。参考图130,杆头部2008作用在保持件边缘2147上的向下压力还使保持件本体2115向外扩张,保持间本体部分地由下裙部表面2121和2121’形成,有利地允许头部2008坐靠在接收件中的位置比其它已知的多轴骨锚以及组件1中所示更低。因此,该裙部特征2121和2121’允许更加稳定的更低的坐靠表面,结合允许杆相对于保持件(且因此相对于整个骨螺钉组件)的增加的角度方向的保持件杯形表面2149,该角度增加是可以的而不需要在接收件底部2108或接近其的位置处提供切开或杯形表面。另外有利的是可将部分被限制的保持件2012相对于接收件2010关于接收件中心轴线旋转,允许使用者选择在接收件2010和杆2004之间的增加的角度方向的位置。
参考图130,在保持件2012向下移动进入接收件2010并位于表面2102和2103上之后,插件2014保持与杆头部2008上方间隔开地设置,因为接收件弹簧凸片2078和/或接收件阶梯表面2094阻止插件2014的向下移动,除非通过工具或者柱2021以及如图130中所示的封闭顶部2018将向下力施加在插件上,例如且如这里之前关于基本相同的锁定插件14说明的。这时,在与封闭顶部锁定之前,接收件2010可枢转至关于相对于杆2004的期望角度位置(例如,图133和134中所示的角度方向),其可由保持件2012内板2117和杆上部分2008之间的摩擦接合保持但不锁定。如上述关于组件1所说明的,这时,可通过工具或者封闭顶部2018向下按压在柱2021上,其进而向下按压插件2014而将锁定和释放插件2014按压至与接收件表面2095成干涉配合关系,如图130中所示。参考图131和132,封闭顶部2018和柱2021可被松开或移除,且组件2001可与可变形柱2921’以及配合封闭顶部2018’配套使用,而不用将多轴机构解锁,如之前关于组件1说明的。如果需要,还可将插件2014解锁,如以上关于组件1说明的。
参考图133-134,示出了杆2004相对于接收件2010的不同角度或铰接位置,其中一些完全使用保持件2112的切口2148和相邻的切开或杯形表面2149。例如,在图134中,杆2008朝向杯形表面2149枢转并与其接合(约三十度铰接),而与之对比在图133所示的布置中,杆2004以与保持件切口2148和表面2149相反的方向枢转(约二十度铰接)。可将与之前这里说明的接收件1010’相似的可选接收件与组件2001的其它元件一起使用,以提供额外角度的角度铰接。
参考图135-137,示出了可选非锁定压缩插件2014’,其用于与这里之前说明的杆2004、接收件2010、保持件2012、封闭顶部2018和柱2021一起使用。插件2014’基本与这里之前说明的非锁定插件214相似。在与接收件装配的过程中,该插件2014’旋转且接收件保持凸片表面2084沿着槽2070’滑动,直到其弹性进入具有条2067’的孔2066’,其与之前这里关于插件214说明的孔和条267相同或相似。条2067’将非锁定插件2014’在保持件2012上方保持到位,直到通过来自柱2021和封闭顶部2018的压力而被设置至与杆头部1008锁定接合。应注意,由于保持件2012是这样初始地被捕获在接收件腔体2061中,条2067’不是必须的,因为保持件2012已经“展开”,即,在与插件2014和杆2004的所有装配步骤过程中,柄脚2118已经在接收件腔室处于中性位置,随着插件2014’的稍稍落下将不会引起保持件2012的意外和不期望的过早展开(如可发生在保持件1012上)。
应理解,尽管已经示出和说明了本发明的一些形式,本发明不限于所说明和示出的部件的具体形式或配置。

Claims (24)

1.一种骨锚,其特征在于包括:
a)杆,其具有本体和一体上部分,所述本体用于固定至骨,所述一体上部分具有第一半径的凸形基本球形第一表面;
b)接收件,其具有底座和形成开口通道的一对直立臂,所述底座限定腔室且具有下开口,所述通道与所述腔室连通;和
c)弹性开口保持件,其被捕获在腔室中且能围绕所述杆上部分的至少一部分扩张,该保持件具有本体和向上延伸的上部结构,该本体部分地限定内边缘且所述上部结构限定多个表面,在所述杆相对于所述接收件的非锁定角度操作过程中该多个表面在所述保持件和所述杆之间提供摩擦配合,且在所述杆相对于所述接收件的最终锁定过程中所述内边缘与所述杆第一球形表面磨擦接合,其中所述保持件与所述杆上部分和所述接收件成仅扩张锁定接合。
2.如权利要求1所述的骨锚,还包括在所述接收件中的插件,该插件具有下表面,所述下表面与所述杆上部分成最终锁定接合。
3.如权利要求1所述的骨锚,其中所述保持件上部结构包括多个向上延伸的内柄脚,各柄脚具有内弧形表面,所述内弧形表面在所述杆相对于所述接收件的非锁定角度操作过程中与所述杆摩擦接合。
4.如权利要求3所述的骨锚,其中所述保持件上部结构还包括多个弹性向上和向外延伸的外柄脚,且所述保持件本体具有底座,该底座具有至少第一平坦表面,且所述接收件具有第二平坦表面,所述第二平坦表面部分地限定所述接收件腔室,且其中在所述杆上部分插入所述接收件底座之前,所述外柄脚与限定所述接收件腔室的上表面接合,并将所述保持件弹性地保持在所述接收件腔室的上部分中,且其中在所述杆上部分穿过所述保持件底座被接收,并且所述保持件底座第一平坦表面坐靠在所述接收件第二表面上之后,所述弹性外柄脚扩张至中性位置且被捕获在所述接收件腔室中。
5.如权利要求4所述的骨锚,其中所述保持件外柄脚具有表面处理以在所述保持件和所述接收件上表面之间提供增大的摩擦系数。
6.如权利要求1所述的骨锚,还包括在所述接收件中的插件,所述插件具有下表面和外结构,所述下表面与所述杆上部分最终锁定接合,且其中所述接收件包括向内突起的弹性凸片,在所述杆上部分和所述保持件装配在所述接收件腔室中的过程中,所述弹性凸片与所述插件外结构暂时接触以保持所述插件,从而在所述杆和保持件被完全地装配并位于接近所述接收件下开口处之前,阻止所述插件将所述保持件推动至在所述接收件腔室的下部分内早期展开。
7.如权利要求1所述的骨锚,其中所述保持件本体具有底座,该底座具有至少第一平坦表面和位于该第一平坦表面下方的下部结构,该下部结构还被定位成在所述杆相对于接收件的操作和最终锁定过程中接近所述内边缘并支撑所述杆上部分,该接收件具有第二平坦表面,该第二平坦表面部分地限定所述接收件腔室并被定位在接近所述下开口处,且其中在最终锁定过程中所述第一平坦表面坐靠在所述第二平坦表面上。
8.如权利要求1所述的骨锚,其中所述杆上部分具有表面处理,从而在所述杆相对于所述接收件的非锁定角度操作过程中在所述杆上部分和所述保持件多个表面之间提供增大的摩擦系数。
9.如权利要求8所述的骨锚,其中所述表面处理是多个脊。
10.一种骨锚,其特征在于包括:
a)杆,其具有本体和一体上部分,所述本体用于固定至骨,所述一体上部分具有弯曲表面;
b)接收件,其具有底座和形成开口通道的一对直立臂,该底座限定腔室且具有下开口,所述通道与所述腔室连通,该底座还由与所述下开口相邻的阶梯部限定,该阶梯部具有第一平坦表面和与该第一平坦表面基本垂直的基本圆柱表面;和
c)弹性开口保持件,其被捕获在所述腔室中且能围绕所述杆上部分的至少一部分扩张,该保持件具有本体和底座,该保持件的该本体具有外表面,该底座具有第二平坦表面,所述保持件还具有在所述第二平坦表面下方且在所述本体的外表面内延伸的下裙部,该保持件底座具有位于所述下裙部上方并与所述下裙部接近的内边缘,在所述杆相对于所述接收件的最终锁定过程中所述内边缘与所述杆上部分弯曲表面磨擦接合,其中所述保持件与所述杆上部分和所述接收件仅扩张锁定接合,且所述保持件第二平坦表面与所述接收件阶梯部接合。
11.如权利要求10所述的骨锚,其中所述接收件阶梯部具有多于一个平坦表面。
12.如权利要求11所述的骨锚,其中所述开口保持件还包括设置在所述下裙部下方的下部裙部,所述下部裙部具有外截头圆锥表面。
13.如权利要求10所述的骨锚,还包括在所述接收件中的插件,该插件具有与所述杆上部分弯曲表面最终锁定接合的下表面。
14.如权利要求10所述的骨锚,其中所述保持件还包括向上延伸的上部结构,其具有至少两个表面,该至少两个表面在所述杆相对于所述接收件的非锁定角度操作中在所述保持件和所述杆之间提供摩擦配合。
15.如权利要求14所述的骨锚,其中所述杆上部分弯曲表面是基本球形的,且所述保持件上部结构包括多个弧形表面,该多个弧形表面在所述杆相对于所述接收件的非锁定角度操作过程中与所述杆上部分弯曲表面成摩擦配合接合。
16.如权利要求15所述的骨锚,其中所述保持件上部结构还包括多个弹性向上和向外延伸的外柄脚,在所述杆被载入所述接收件之前或过程中,该外柄脚与限定所述接收件腔室的上表面接合并将所述保持件弹性地保持在所述接收件腔室的上部分中,在所述杆相对于所述接收件的最终锁定之前所述外柄脚扩张至中性状态并被捕获在所述接收件腔室中。
17.如权利要求10所述的骨锚,其中所述保持件包括下凹进表面,该下凹进表面被尺寸设置和成形以接收所述杆的一部分,从而提供所述杆的增大枢转角度。
18.如权利要求17所述的骨锚,其中所述保持件下凹进表面被定位在所述保持件的表面之间的间隙中。
19.一种骨锚,其特征在于包括:
a)杆,其包括用于固定至骨的本体和具有第一弧形表面的一体上部分;
b)接收件,其具有顶部分和底座,该接收件顶部分限定开口通道,该底座限定具有上扩大部分和与底部开口连通的下部分的腔体,该通道与所述腔体连通,所述底座具有第一平坦表面,该第一平坦表面部分地限定所述腔体下部分并被定位在接近所述底部开口处;
c)至少一个插件,其被布置在所述接收件中,所述插件具有用于与所述第一弧形表面最终锁定接合的第二弧形表面;和
d)弹性开口保持件,其被捕获在所述腔体中并能在所述接收件腔体的上扩大部分中围绕所述杆的至少一部分扩张,所述保持件包括具有内边缘的本体和在所述本体下方延伸的下部结构,该本体具有与所述下部结构相邻地设置的第二平坦表面,在所述杆相对于所述接收件的锁定过程中所述第二平坦表面位于所述内边缘下方且坐靠在所述接收件第一平坦表面上,其中扩张锁定接合发生在所述杆上部分和所述保持件内边缘之间以及在所述保持件和所述接收件之间。
20.如权利要求19中所述的骨锚,其中所述插件具有被尺寸设置和成形以与所述接收件锁定干涉配合的表面。
21.如权利要求19所述的骨锚,其中所述杆上部分第一弧形表面是基本球形的,且所述保持件还包括多个柄脚形式的上部结构,各柄脚具有弧形表面,该弧形表面在所述杆相对于所述接收件的非锁定角度操作过程中与所述杆上部分基本球形表面磨擦配合接合。
22.如权利要求21所述的骨锚,其中所述保持件上部结构还包括多个弹性向上和向外延伸的外柄脚,该外柄脚与上表面接合,该上表面位于所述扩大部分上方限定接收件腔体,在将所述杆载入所述接收件之前和过程中该外柄脚将所述保持件弹性地保持在所述接收件腔室的扩大部分中,在将所述杆相对于所述接收件最终锁定之前该外柄脚扩张至中性状态且被捕获在所述接收件腔室中。
23.一种骨锚,其特征在于包括:
a)杆,其包括用于固定至骨的本体和具有第一弧形表面的一体上部分;
b)接收件,其具有顶部分和底座,该接收件顶部分限定开口通道,该底座限定腔体,所述通道与所述腔体连通;
c)设置在所述接收件内的至少一个插件,该插件具有用于与所述第一弧形表面最终锁定接合的第二弧形表面;
d)弹性开口保持件,其被捕获在所述腔体中且能围绕所述杆的至少一部分扩张,所述保持件具有本体,多个内柄脚,多个外柄脚,和内边缘,该内柄脚各具有第三弧形表面,该第三弧形表面与所述杆第一弧形表面摩擦地配合,在所述杆相对于所述接收件的非锁定角度操作过程中提供在所述保持件和所述杆之间的摩擦配合,所述外柄脚被捕获在所述接收件腔体中且所述保持件能关于所述接收件的中心轴线旋转;和
e)其中扩张锁定接合发生在所述杆上部分和所述保持件内边缘之间以及在所述保持件和所述接收件之间。
24.如权利要求23所述的骨锚,其中所述保持件本体具有底座,该底座具有至少一个第一平坦表面和位于该第一平坦表面下方的下裙部的至少一部分,该下裙部还部分地限定所述内边缘并在所述杆相对于所述接收件的操作和最终锁定过程中支撑所述杆上部分,所述接收件具有部分地限定所述接收件腔室的第二平坦表面,且其中在所述最终锁定过程中所述第一平坦表面坐靠于所述第二平坦表面上。
CN201280054722.4A 2009-06-15 2012-09-07 包括套接杆和具有低外形边缘锁的摩擦配合保持件的多轴骨锚 Pending CN103917181A (zh)

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