CN101394814A - 用于椎间融合移植物的经椎间孔椎间融合器和用于移植椎间融合器的器械 - Google Patents

用于椎间融合移植物的经椎间孔椎间融合器和用于移植椎间融合器的器械 Download PDF

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CN101394814A
CN101394814A CNA200780008095XA CN200780008095A CN101394814A CN 101394814 A CN101394814 A CN 101394814A CN A200780008095X A CNA200780008095X A CN A200780008095XA CN 200780008095 A CN200780008095 A CN 200780008095A CN 101394814 A CN101394814 A CN 101394814A
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fusion device
invasive lumbar
lumbar fusion
main body
bar
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CN101394814B (zh
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雷金纳德·詹姆斯·戴维斯
凯文·考夫曼
格雷戈·霍夫曼
阿兰·麦克吉
让·于伯特
于格·穆塞尔拉德
吕多维克·里拉东
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LDR Medical SAS
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LDR Medical SAS
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Abstract

本发明涉及一种用于椎间融合移植物的经椎间孔椎间融合器(1)，和用于移植椎间融合器的器械和方法，椎间融合器的一个实施例具有圆弧形形状的主体，并且包括侧凹入表面(10)、侧凸出表面(11)、笔直的上表面(12)、笔直的下表面(13)和端壁(14)，所述端壁具有至少一个孔(30)，称为端孔，设计用来容纳用于将椎间融合器移植在椎骨之间的器械(5)的杆(53)，其中，所述端孔具有基本正切于由所述主体形成的圆弧的方向；与所述主体的端壁相对的末端包括将所述主体朝向由所述主体描绘的所述圆弧所处的圆上的中心延伸的弯折部(15)。

Description

用于椎间融合移植物的经椎间孔椎间融合器和用于移植椎间融合器的器械
交叉引用
本申请要求2006年2月15日在法国递交的法国专利申请No.FR0601315，其出于所有目的通过引用并入本文。
技术领域
本发明涉及椎间固定术(intervertebral arthrodeses)(两个椎骨的融合)领域，更具体地，涉及植入两个相邻椎骨之间以允许骨组织移植物插入椎间盘空间(disc space)中并且在椎间盘空间中生长的椎间融合器(intersomatic cages)。事实上，在椎间融合器插入或移植之后，椎间空间由自体同源的松质骨(autologousspongy bone)或适当的骨替代物填充。本发明还涉及用于特别是通过椎间孔入路(tranforaminal approach)将椎间融合器移植到椎骨之间的器械。椎间融合器设计用于设置在两块椎骨之间，以通过更换椎间盘恢复和/或保持椎间盘空间，并且骨组织或替代物的移植物被设计成允许在其插入的两个相邻椎骨之间的融合。
背景技术
从现有技术可知各种类型的椎间融合器。从现有技术已知的一些椎间融合器由骨，通常由皮质骨(cortical bone)机加工形成，以与插入椎间盘空间中的移植物融合。这些由骨构成的椎间融合器具有在不充分杀菌的情况下造成疾病的缺点。
从现有技术还可知各种类型固体材料的不同椎间融合器。这些椎间融合器在其下表面、上表面和至少一个侧表面上具有开口。这些椎间融合器中的一种，特别是从由本申请人递交的专利申请WO0187194(A1)中已知的，具有开口环形形状，并且通过将两个椎间融合器的开口侧表面彼此相对放置，可与相同类型的另一个椎间融合器结合使用。不管所讨论的椎间融合器的类型，松质骨在椎间融合器内部压紧，以最终实现由适当的椎间盘空间分隔的两个椎骨的骨融合(或关节固定)。从现有设计已知的其他椎间融合器为平行六面体形状，椎间融合器的顶部和底部完全开放，并且顶部和底部开口设计成面向两个必须保持彼此分离的椎骨设置。形成在平行六面体侧面中的开口允许移植物朝向椎间融合器的外部生长，并且可能接触移植在也插入椎间盘空间中的另一个椎间融合器中的移植物。这些椎间融合器具有以下缺点：首先，在环面(annulus)中(椎间盘的外部)需要相对大的切口(incision)，其次，在实现关节固定之前，由于移植物限制在椎间融合器中心处的腔室内，因此需要相对长的时间，第三，具有太大的尺寸，以至于不进行设置在椎间孔入路延伸经过的孔后面的关节突(articular processes)的部分或全部切除无法通过椎间孔入路进行移植。
从现有技术的现有设计，特别是从美国专利申请US 2005/0038511(A1)还已知由骨机加工的各种形状和尺寸的椎间融合器，特别是香蕉(或简单的括号)状的椎间融合器，形成椎间融合器纵轴，并且具有都是笔直的具有锯齿且基本平行于椎间融合器纵轴的下表面和上表面，凹入的侧壁，凸出的侧壁，和基本垂直于顶部和底部表面的两个笔直端壁。椎间融合器端壁之一包括孔，所述孔定向为朝向椎间融合器中心，并且用于容纳用来将椎间融合器插在椎骨之间的器械的杆。该椎间融合器具有在骨组织中的缺点，并且因此如前面所述，在不充分杀菌的情况下，能够引起疾病。该椎间融合器还具有最终不够结实而不能可靠地承受移植到椎间盘空间中时施加到其的应力的缺点。而且，该椎间融合器具有这样的缺点：具有朝向椎间融合器中心特别是朝向凹入表面中心定向的孔，其结果使椎间融合器甚至更脆弱。而且，由该孔限定的轴线关于与凹入和凸出表面之一的切向平行的轴线形成角度，所述角度太大，以至于不能使用来将椎间融合器插在椎骨之间的器械沿基本平行于凹入和凸出表面之一的切向方向装配到椎间融合器上。因而，孔的方向与由其凸出和凹入表面获得的椎间融合器的总曲率不一致，并且不能在其曲率轴线上使推力有效施加到椎间融合器。由于该孔而变得脆弱的所述椎间融合器因此在压力必须以相对于椎间融合器的曲率轴线过大的角度施加时具有断裂的危险，这因此证明很难经椎间孔入路移植。最后证明，由于所述孔的不适当的方向，很难将插入所述孔中的器械撤出。
本文中，关注于提出一种优选结实且无菌材料的椎间融合器，其具有使其适于经椎间孔入路移植而没有关节突过大的障碍，并且能够以与椎间融合器总体形状一致的方向安装到用于将椎间融合器插入椎骨之间的器械上。还关注于提出一种用于移植椎间融合器的器械，所述器械设计成椎间融合器的形状和尺寸能够使椎间融合器容易地移植在椎骨之间。从现有技术还已知用于椎间融合器移植的器械的现有设计，所述器械具有至少一个插入到椎间融合器中的孔中的杆，以将杆在经过所述孔的过程中固定。但是，从现有技术已知的这些器械中的一些器械在所述椎间融合器和器械具有过大尺寸时需要至少一部分阻止进入所述孔的关节突的切除。而且，椎间孔入路被相对阻碍，并且不是完全笔直。因此期望所述器械应在固定椎间融合器的端部处具有肘(弯曲或倾斜部分(angled portion))。从现有技术已知的一些器械具有不需要关节突切除的足够小的尺寸，并且一些器械具有允许器械绕过阻挡进入椎间盘空间的结构的倾斜部分(angled portion)，但是设计用于固定椎间融合器的杆和该杆插入其中的椎间融合器的孔具有与允许椎间融合器插入到椎骨之间的最佳推力轴线不非常相容并且与椎间融合器已经移植时所述杆容易撤出不非常相容的方向。因此期望提出一种器械，其形状和尺寸适于使用椎间孔入路插入，具有绕过阻挡进入椎间盘空间的结构的倾斜部分，并且具有以最佳方向插入椎间融合器中的孔内的杆，以便于椎间融合器移植在椎骨之间，以及后来器械的撤出。
发明内容
本发明的目的是通过提出一种椎间融合器来消除现有设计中的一些缺点。该椎间融合器用于具有适当形状并且限定尺寸的椎间融合移植物经椎间孔入路移植，同时还具有足够的强度来有效地保持允许移植物生长的椎间盘空间。
该目的通过一种用于椎间融合移植物的椎间融合器实现，所述椎间融合器包括通常形成弧形的主体，所述主体包括：
侧凹入表面；
侧凸出表面；
基本上横向的上表面；
基本上横向的下表面；
端壁，其位于所述主体的第一纵向末端(first longitudinal extremity)，所述端壁包括端孔，该端孔构造成用于容纳移植器械的杆的保持端，并且定向为基本上正切于由所述主体形成的弧形；和
向内弯曲的弯折部，其位于所述主体的第二纵向末端并与所述端壁相对。
根据另一个特征，所述端壁包括凹部，该凹部构造成用于容纳移植器械的销。
根据另一个特征，所述弯折部包括弯折孔，该弯折孔定向为基本上正切于由所述主体形成的弧形，并且构造成用于容纳移植器械的端部。
根据另一个特征，所述端壁包括凹部，该凹部构造成用于容纳移植器械的销，所述端孔、所述凹部和所述弯折孔构造成分别与移植器械的杆的保持端、销和端部配合，以确保通过移植器械抓握椎间融合器。
根据另一个特征，所述主体的上表面和下表面中的至少一个表面包括锯齿，该锯齿定向成阻止椎间融合器跟随椎间融合器的椎间移植而运动。
根据另一个特征，所述弯折部包括上表面和下表面，该上表面和下表面分别延伸所述主体的上表面和下表面，所述弯折部的上表面和下表面中的至少一个表面包括锯齿，该锯齿构造成阻止椎间融合器跟随椎间融合器的椎间移植而运动。
根据另一个特征，所述弯折部包括上表面和下表面，该上表面和下表面分别延伸所述主体的上表面和下表面，所述弯折部的上表面和下表面中的至少一个表面包括倒角(chamfer)，该倒角构造成有利于所述椎间融合器的椎间移植。
根据另一个特征，所述主体的所述第一和第二纵向末端形成所述椎间融合器的纵轴，并且至少一些锯齿定向为基本上平行于所述椎间融合器的纵轴。
根据另一个特征，所述主体的所述第一和第二纵向末端形成所述椎间融合器的纵轴，并且至少一些所述锯齿定向为基本上垂直于所述椎间融合器的纵轴。
根据另一个特征，所述主体的所述第一和第二纵向末端形成所述椎间融合器的纵轴，并且至少一些锯齿关于基本上垂直于所述椎间融合器的纵轴的轴线以波浪形结构(chevron configuration)布置。
根据另一个特征，所述主体的所述第一和第二纵向末端形成所述椎间融合器的纵轴，并且至少一些锯齿形成同心圆弧，其每一个圆弧关于基本上平行于所述椎间融合器的纵轴的对称轴而对称于由所述主体形成的圆弧。
根据另一个特征，至少一些所述锯齿定向为基本上法向于由所述主体形成的弧形。
根据另一个特征，在所述椎间融合器的上表面或下表面上的所有锯齿具有基本上相同的方向。
根据另一个特征，在所述椎间融合器的上表面或下表面上的一些锯齿不具有与在所述椎间融合器相同表面上的其他锯齿相同的方向。
根据另一个特征，在所述椎间融合器的上表面和下表面中的每一个表面上的锯齿具有相同的方向。
根据另一个特征，在所述椎间融合器的上表面上的锯齿具有不同于所述椎间融合器的下表面上的锯齿的方向。
根据另一个特征，所述主体包括辐射不透明标记(radio-opaque marker)，其构造成用于以x射线图像来标识所述椎间融合器。
根据另一个特征，由所述椎间融合器的上表面和下表面形成的平均平面(mean planes)基本上彼此平行。
根据另一个特征，由所述椎间融合器的上和下表面形成的平均平面形成能够矫正脊柱缺陷的角度。
根据另一个特征，所述椎间融合器的表面的至少一个表面包括至少一个能够使骨移植物或替代物生长的开口。
根据另一个特征，至少一个切口(slit)经过所述椎间融合器的所述主体，并且形成从所述椎间融合器的表面的至少一个表面延伸到另一个表面的管道，所述切口构造成用于容纳固定物(anchor)，所述固定物包括被冲击进(be impactedinto)椎体内的平直固定物板，所述椎间融合器与所述平直固定物板相接触。
本发明的另一个目的是提出一种用于将椎间融合器移植在椎骨之间，利于进入椎间盘空间中，并且允许在椎间融合器上获得良好抓握的器械。
该目的通过一种用于椎间融合移植物的椎间融合器移植的器械实现，所述椎间融合移植物的椎间融合器包括通常形成弧形的主体，所述主体包括侧凹入表面；侧凸出表面；基本上横向的上表面；基本上横向的下表面；在所述主体第一纵向末端处的端壁，所述端壁包括定向为基本上正切于由所述主体形成的所述弧形的端孔；所述器械包括：
杆，该杆包括保持端，该保持端构造成用于插入所述端孔中；
抓握端，用于抓握所述椎间融合器，所述抓握端包括：
支撑压舌板，其包括底部，并且通常形成与由所述主体形成的弧形互补的弧形；
引导管，所述杆可滑动地布置其中，并且所述支撑压舌板的底部安装到其上，所述引导管包括开口，所述杆的保持端可穿过所述开口，用于插入所述端孔中；和
操纵端，用于操纵所述器械。
根据另一个特征，所述杆基本上延伸到所述器械的操纵端附近。
根据另一个特征，所述器械包括按钮和凹槽，该按钮连接到所述杆，该按钮从该凹槽突出，该按钮构造成用于滑动所述杆以关于所述引导管中的开口来调节所述杆的保持端的位置。
根据另一个特征，所述引导管包括销，该销构造成用于接合布置在所述椎间融合器的端壁上的凹部。
根据另一个特征，所述支撑压舌板包括远离(distalfrom)所述底部的端部，所述端部构造成用于插入布置在所述椎间融合器的向内弯曲的弯折部上的弯折孔内，所述弯折孔定向为基本上正切于由所述主体形成的弧形。
根据另一个特征，所述引导管包括销，该销构造成用于接合布置在所述椎间融合器的端壁上的凹部，所述杆的所述保持端、所述销和所述移植器械的所述端部构造成分别与所述端孔、所述凹部和所述弯折孔配合，以确保通过所述移植器械抓握所述椎间融合器，并且有利于通过从所述端孔拆卸所述杆的保持端而在所述椎间融合器移植后撤出所述器械。
根据另一个特征，所述器械还包括目标管，其基本上延伸到所述器械的操纵端附近，其中，所述引导管包括移动部，该移动部关于所述目标管至少在主要枢转方向上枢转，该主要枢转方向基本上位于由所述支撑压舌板形成的弧形所处的平面内，并且所述移动部关于所述目标管的位置形成枢转角。
根据另一个特征，所述移动部或所述目标管中的一个包括基本上半球状(sphere)的端部，并且所述移动部或所述目标管的另一个包括具有形状和尺寸与所述半球状端部的形状和尺寸互补的凹入端，所述半球状端部和所述凹入端分别构成为球窝连接的球部件和窝部件。
根据另一个特征，所述窝部件包括开口边缘部，所述开口边缘部中的一个开口边缘部靠近所述支撑压舌板，并且构造成围绕所述球部件小于其他开口边缘部，以使所述移动部关于所述目标管至少在主枢转方向上进一步枢转。
根据另一个特征，所述杆为挠性杆，并且通过设置在所述球部件和所述窝部件中心处的通道可滑动地穿过球窝连接，所述通道具有靠近所述支撑压舌板的中空部，所述中空部构造成甚至当所述运动部关于所述目标管枢转时所述杆仍滑动穿过所述球窝连接。
根据另一个特征，所述器械还包括可滑动地沿所述目标管布置的锁，所述锁具有向前位置，并且构造成当所述锁布置在向前位置中时以所选枢转角度固定所述引导管的所述运动部。
根据另一个特征，所述运动部包括锯齿，该锯齿构造成用于增加最大枢转角，所述引导管的所述运动部以所述最大枢转角可由所述锁固定，并且该锯齿还构造成用于提供预定的枢转角。
根据另一个特征，所述锯齿构造成用于与所述锁接合，而无需将所述锁布置在向前位置中，所述接合建立预定的枢转角，并且防止所述运动部枢转。
根据另一个特征，所述器械的操纵端包括手柄，该手柄构造成操纵所述器械，并且有利于所述椎间融合器在所述椎骨之间的移植。
本发明的另一个目的是提出一种使用根据本发明的器械用于移植根据本发明的椎间孔椎间融合器的方法。
该目的通过一种用于将椎间融合移植物的椎间融合器移植到脊柱的相邻椎骨之间的椎间盘空间内的方法实现，所述椎间盘空间包括环面和核心，所述方法包括以下步骤：
提供一种用于椎间融合移植物的椎间融合器，所述椎间融合器包括形成弧形的主体，所述主体包括：
侧凹入表面，
侧凸出表面，
基本上横向的上表面，
基本上横向的下表面，
端壁，位于所述主体的第一纵向末端处，所述端壁包括端孔，该端孔构造成用于容纳移植器械的杆的保持端，并且定向为基本上正切于由所述主体形成的弧形，和
向内弯曲的弯折部，位于所述主体的第二纵向末端处并与所述端壁相对，所述弯折部包括弯折孔，该弯折孔定向为基本上正切于由所述主体形成的弧形并且构造成用于容纳移植器械的端部；
提供一种器械，包括：
杆，其包括保持端，该保持端构造成用于插入所述端孔中，
抓握端，其用于抓握所述椎间融合器，所述抓握端包括支撑压舌板，所述支撑压舌板包括底部，并且通常形成与所述主体形成的弧形互补的弧形，所述支撑压舌板包括远离所述底部的端部，该端部构造成用于插入所述椎间融合器的弯折孔内，和
引导管，所述杆可滑动地布置其中，并且所述支撑压舌板的底部安装到其上，所述引导管包括开口，所述杆的所述保持端可穿过所述开口，用于插入所述端孔中；和
操纵端，用于操纵所述器械；
形成切口来进入脊柱；
切入环面，并且从椎间盘空间去除核心；
将所述压舌板的端部插入所述椎间融合器的所述弯折孔中；
将由所述主体形成的弧形靠近由所述压舌板形成的弧形布置；
通过将所述杆的保持端插入所述端孔中将所述椎间融合器固定在所述器械上；
将所述椎间融合器布置在弧形运动中的椎间盘空间中；
通过从所述端孔卸下所述保持端将所述椎间融合器从所述器械释放；
将所述器械从所述椎间盘空间去除；和
缝合环面和皮肤。
根据另一个特征，将所述椎间融合器布置在所述椎间盘空间中的所述步骤继续或伴随有将所述器械的运动部关节连接为所选角度的步骤，之后跟随有将所述运动部以所选角度锁定的步骤。
根据另一个特征，在将所述椎间融合器布置在所述椎间盘空间中的步骤之后跟随有通过使用x射线检测包括在所述椎间融合器的主体中的辐射不透明标记来确定所述椎间盘空间中椎间融合器的位置和方向，并且如果这样的位置或方向不正确，则调整所述椎间盘空间中的所述椎间融合器的位置或方向的步骤。
根据另一个特征，在将所述压舌板的端部插入所述椎间融合器的弯折孔中和将由所述主体形成的弧形靠近由所述压舌板形成的弧形布置的步骤之后跟随有将所述器械的销与布置在所述椎间融合器端壁上的凹部接合的步骤，并且在通过将所述杆的保持端插入到所述端孔将所述椎间融合器固定在所述器械上的步骤之后，继续进行将所述器械的销与布置在所述椎间融合器端壁上的凹部接合的步骤。
根据另一个特征，在将所述椎间融合器布置在所述椎间盘空间中的步骤之后，进行将所述相邻的椎骨分离的步骤。
附图说明
本发明的其他特征和优点将在阅读下面参照附图提供的描述时变得更清楚，附图中：
图1A、1B、1C和1D为根据本发明各实施例的椎间融合器的立体视图；
图2A和2C为用于将椎间融合器移植到椎骨之间的器械的一个实施例器械抓握端分别在笔直和倾斜位置中的外形图，图2B和2D分别显示了在图2A和2C中分别由圆圈2B和2D标示的部分的细部；
图3A提供了用于移植椎间融合器的器械的一个实施例关于平面截面3B-3B的俯视图，图3B显示了根据插入器械的该实施例的轴线3B-3B的剖视图，并且图3C和3D显示了图3B中分别由圆圈3C和3D标示的部分的细部；
图4A提供了使用将固定在器械抓握端处的椎间融合器插入的方法的用于移植椎间融合器的器械的一个实施例的外形图，图4B显示了图4A中由圆圈4B标示的部分的细部，图4C显示了关于平面截面4D-4D的固定椎间融合器的器械的该实施例俯视图，其中，图4D提供了根据该实施例轴线4D-4D的剖视图，并且图4E显示了由图4D中圆圈4E标示的部分的细部；
图5A和5B提供了根据本发明的椎间融合器的两个不同实施例的立体视图，图5C提供了根据本发明的椎间融合器的另一个实施例的俯视图；
图6A提供了根据本发明的椎间融合器的另一个实施例的俯视图，图6B和6C分别提供了根据本发明另一个实施例的固定物的俯视图和侧视图。
具体实施方式
本发明涉及用于椎间融合移植物的经椎间孔椎间融合器。该椎间融合器用于保持足够的椎间盘空间，使移植物插入椎间盘空间中来生长并且使相邻的椎骨骨质融合(关节固定(arthrodesis))。该椎间融合器由于其特别适于经椎间孔入路移植，因此被称为经椎间孔，但是其也可通过任何适用于便于负责移植的外科医生的方法移植。该椎间融合器具有圆弧形状的主体1，所述主体1具有侧凹入表面10、侧凸出表面11、笔直上表面12和笔直下表面13。主体1因此具有近似香蕉状或简单的括号状，并且因此确实描绘为圆弧状。
根据本发明各实施例的椎间融合器的该圆弧形状与椎板边缘形状特别匹配，这使得椎间融合器设置在椎板外围附近，也就是说在其最结实的部分上。根据本发明各实施例的椎间融合器将因此移植在例如椎板前外围部的高度处。椎间融合器靠近椎板边缘的该设置还能够获得用于骨移植物或替代物的大的起始面(initial surface)。在主体1一个末端处，所述椎间融合器包括具有至少一个孔30的端壁14，孔30称为端孔，其设计成用于容纳用来将椎间融合器移植到椎骨之间的器械5的杆53。
在根据本发明的椎间融合器特别有利的实施例中，端孔30具有基本正切于由主体1描绘的圆弧的方向。端孔30正切于由主体1描绘的圆弧的该方向有利于椎间融合器被椎间融合器移植器械5推进，并且分别有利于该器械5的杆53插入到端孔30内和从端孔30撤出。而且，该端壁14包括至少一个凹部31，该凹部31设计成用于容纳椎间融合器移植器械5的至少一个销54。该凹部31提供一个附加表面，用于由该器械抓握椎间融合器。其可包括简单的肩部或更复杂形状的凹部，例如具有凹槽的凹部，凹槽中可锁定器械5的销54的锯齿(serration)(因而具有例如刺状)。
在根据本发明特别有利的椎间融合器的实施例中，与主体1的端壁14相对的末端包括弯折部15，该弯折部15使主体1朝向由主体1描绘的圆弧位于其上的圆的中心延伸。该弯折部提供了椎间融合器在椎骨之间的更好的稳定性，而没有过多地增加其尺寸。该弯折部用于防止椎间融合器在当移植在患者的两个椎骨之间时受到的应力作用下倾斜到其一侧。而且，该弯折部15包括至少一个孔32，称为弯折孔，其方向基本正切于由主体1的凹入表面10形成的圆弧，并且设计成用于容纳椎间融合器移植器械5的至少一个端部55。因而，器械5可包括具有与主体描绘的圆弧形状互补的形状的压舌板56。该压舌板56因而通过装配其主体1而紧靠椎间融合器的形状。在压舌板56的一端处，端部55可设计成用于插入该弯折孔32中。端孔30、凹部31和弯折孔32与杆53装配在一起时，椎间融合器移植器械5的销54和端部55在杆53的一端放置在端孔30中时分别确保由器械5在椎间融合器上的良好抓握。该椎间融合器的完全抓握甚至到最远端的完全抓握，通过提供在器械5端部处椎间融合器的良好稳定性，而有利于椎间融合器的移植。该良好稳定性在经椎间孔入路移植的情况下也特别重要。杆53设计用来在器械5中滑动，以使其可从端孔30撤出，并且使椎间融合器不受约束，使器械5撤出。
主体1上表面和下表面中的至少一个表面配备有锯齿20，其阻止(oppose)椎间融合器关于其植入其间的相邻椎骨运动。本发明提供不同可能方向的锯齿20。以有利的方式，在本发明的一个实施例中，存在于椎间融合器的两个相对表面上的锯齿20可能不具有相同的方向，以阻止椎间融合器沿用于每一个表面的不同方向的运动，如具体在图1A到1C中所示。在另一个实施例中，存在于椎间融合器相对表面上的锯齿20将具有相同的方向，如具体在图1D中所示。同样，存在于椎间融合器一个表面上的锯齿20可具有与设置在相同表面上的其他锯齿不同的方向。相反地，存在于椎间融合器指定表面上的所有锯齿20可具有相同的方向。根据该实施例，椎间融合器可因此包括其所有表面或任一部分表面上的这些方向的任一组合。由主体1描绘的圆弧的末端形成椎间融合器的纵轴。椎间融合器在该纵轴上具有比在垂直于其的轴上更大的尺寸。该纵轴将允许锯齿形成不同的可能方向。因而在一个实施例中，至少一部分锯齿20可平行定向，如图1C中具体所示，或垂直于椎间融合器的该纵轴定向。在另一个实施例中，其可定向成关于椎间融合器的该纵轴形成0和90度之间的角度。在另一个实施例中，至少一部分锯齿20可描绘为关于垂直于该纵轴的轴为中心的臂章状(chevrons)，如图1A中具体所示。在另一个实施例中，至少一部分锯齿20可描绘为同心圆弧，每一个圆弧关于由主体1描绘的圆弧具有轴对称，其对称轴平行于椎间融合器的该纵轴。在另一个实施例中，至少一部分锯齿20将平行于由主体描绘的圆弧位于其上的圆所限定的半径定向，如图1B和1D中具体所示。
而且弯折部分15包括上表面和下表面，该上表面和下表面分别延伸主体1的上表面和下表面。在一个实施例中，弯折部15的这些上表面和下表面中的至少一个表面还可配备阻止椎间融合器运动的锯齿。在另一个实施例中，弯折部15的这些上表面和下表面中的至少一个表面可包括至少一个有利于椎间融合器插入椎间盘空间中的倒角16，如图1A中具体所示。
在图中所示的实施例中，椎间融合器1的上表面和下表面通常平直，并且由这些上表面和下表面形成的平均平面基本上彼此平行。在本发明的一些实施例(未显示)中，由椎间融合器1的上表面和下表面形成的平均平面彼此不平行。这些平面可因而形成允许矫正脊柱(椎骨的方向)缺陷的角度。在这样的实施例中，椎间融合器1可在椎骨之间移植时施加脊椎前凸(lordosis)。由于几个椎间融合器1可在单个的椎间空间内一起使用，因此这样的实施例允许在任何方向上矫正脊柱的缺陷，因为在其上表面和下表面之间可使用具有不同角度的椎间融合器1的任意组合。
在本发明的一些实施例中，如在图5A到5C和6A中具体所示，椎间融合器的至少一个表面包括至少一个开口(21或22)。如图所示，椎间融合器1可包括设置在其上和/或下表面上的这样的开口21，并且还可包括在其至少一个侧表面10、12上的这样的开口22。在各实施例中，这样的开口21、22可形成盲孔或可形成穿过椎间融合器主体的管道。这样的开口通过使骨移植物或替代物能够在开口内生长而使椎间融合器固定在椎骨上。骨移植物或替代物可因而插入开口21、22内部，或可简单地放置在椎间空间中，并且在开口内生长。特别当椎间融合器包括形成从上表面延伸到下表面的管道的开口21时，如图6A中所示，椎间融合器1还特别有利地包括穿过开口21用于加固椎间融合器1的横木23。
在本发明的一些实施例中，椎间融合器包括至少一个切口33，其穿过椎间融合器1主体并且从椎间融合器的至少一个表面向另一个表面，即上表面和/或下表面和/或端壁和/或凹入表面10和/或凸出表面12和/或弯折部15的一个表面延伸。如图5A中所示，切口33可例如从端壁14延伸到椎间融合器的上表面，但是可从凹入表面12延伸到椎间融合器的下表面，如图5B中所示。该切口33用于容纳固定物4，所述固定物4被冲击进椎骨中。如图6B和6C中所示，固定物4包括基本矩形的平直板40，用于进入切口33，并且压紧在椎骨中，因而能够将椎间融合器1固定在椎骨中。切口33因而为穿过椎间融合器1主体的管道，并且可具有适于容纳固定物4的矩形截面。固定板40可包括槽口42，该槽口42定向成将固定物4保持在椎骨中。在变体实施例中，固定板40可在其一端包括用于便于其穿入椎体中的倒角或斜面(chamfer orbevel)(图6C中可见)。在变体实施例中，在与包括倒角的一端的相对端，固定板4可包括用于将固定物固定在椎间融合器1上的弯折部41。该弯折部41可以存在于弯曲部分，如图6C中所示，其可互锁在主体一个表面上切口33的开口的边缘上。在变体实施例中，切口33的边缘可包括用于便于固定物4的弯折部41互锁的凹槽。在变体实施例中，固定物4包括靠近弯折部41的挠性凸片43，该挠性凸片43朝向固定物4的弯折部41定向。在该变体中，这些挠性凸片43构造成紧靠固定板40的边缘折回，以允许固定物4插入椎间融合器1的切口33中。在固定物4的该实施例中，椎间融合器1的切口33的内壁包括用于容纳挠性凸片43并且将固定物4固定到椎间融合器1中的凹部。在该实施例中，固定物4的弯折部41可简单地存在于例如形成与切口设置其上的椎间融合器的表面相配合的阻挡部的固定板40的增大部。根据所选实施例，切口33的方向和因而插入其中的固定物4的方向可相对于椎间融合器的上表面或下表面形成5度和85度之间的角。椎间融合器1可包括具有相同或不同角度的用于几个固定物4插入的几个切口33，并且这里描述的固定物4和切口33各实施例可在椎间融合器1的任何实施例中使用，而与其形状(上表面和下表面之间的角度)和存在或不存在开口(21和/或22)无关。
本发明还涉及用于将椎间融合器移植在椎骨之间的器械5。根据本发明的该器械特别适于经椎间孔入路用于椎间融合移植物的椎间融合器的移植，但是其当然可用于任何便于负责移植的外科医生的方法。器械5特别设计适于与前面描述的椎间融合器结合使用。根据本发明实施例的器械5包括用于抓握椎间融合器使椎间融合器固定在器械端部并且称为抓握端的末端(extremity)。该器械与其抓握端相对的末端允许器械由外科医生操纵，并且被称为操纵端。器械5的抓握端包括至少一个管52，称为引导管。在该引导管52的末端，在引导管52的一个边缘上安装压舌板56，称为支撑压舌板。该压舌板56具有圆弧形状，设计用于至少部分装配到由椎间融合器主体1描述的圆弧上。通过紧靠(hugging)主体1的形状，该压舌板给椎间融合器提供坚固性。压舌板将因此保护椎间融合器，特别是防止压紧。在支撑压舌板56底部，引导管52包括开口，杆53的一端穿过所述开口来装配在椎间融合器的端孔30中。该杆53安装来在引导管52中滑动，并且具有使其适于插入椎间融合器端孔30中的形状和尺寸，以允许椎间融合器抓握。在一个实施例中，该杆53延伸到器械5的操纵端附近。杆53包括至少一个按钮61，该按钮61突出穿过器械5的至少一个边缘上的凹槽610。该按钮61允许杆53滑动，并且其位置相对于存在于固定支撑压舌板56的引导管52端部处的开口调节。该按钮将优选设置在杆53的末端处，并且根据本实施例，可因此靠近器械5的操纵端设置，或设置在器械上的任何位置，但是原则上靠近操纵端显然更实用。
在一个实施例中，在支撑压舌板56安装其上的端部处，但是在相对的边缘上，引导管52包括至少一个销54，其形状和尺寸适于装配在存在于椎间融合器的端壁14上的至少一个凹部31上。该实施例特别适于上面提出的椎间融合器的实施例中的一个，并且通过器械5提高椎间融合器上的抓握质量。
在一个实施例中，在引导管52的相对端处，支撑压舌板56包括至少一个端部55，其形状和尺寸使其适于插入至少一个称为弯折孔的存在于椎间融合器的弯折部15上的孔32内。该实施例特别适于这样的椎间融合器的实施例中之一，其中弯折部15将主体1朝向由主体1描绘的圆弧形位于其上的圆的中心延伸。由于该弯折孔32具有基本正切于由主体1的凹入表面10形成的圆弧的方向，在圆弧中压舌板56的端部处的端部55将因此具有特别适于装配到弯折孔32中的形状。在用于将上面描述的器械和椎间融合器1装配在一起的方式结合的一个实施例中，通过将椎间融合器移植器械5的杆53、销54和端部55分别一起装配到椎间融合器的端孔30、凹部31和折弯孔32，确保当杆53的一端放置在端孔30中时由器械5在椎间融合器上的良好抓握，并且利于椎间融合器的移植。
在特别有利的并且适于经椎间孔入路的实施例中，在与固定支撑压舌板56的端部相对的端部处的引导管52包括运动部57，其关于称为目标管、延伸到靠近器械5的操纵端的管59枢转。该运动部57沿基本平行于由支撑压舌板56形成的圆弧的方向的至少一个方向枢转。如在图3C中具体示出，运动部57和目标管59一起可形成球窝连接(或枢转连杆(swivel link))，其中的一个具有球或半球592形式的一端，另一个具有形成窝的中空端，称为半球凹部571，其形状和尺寸与该半球的形状和尺寸互补。在图3C中示出的实施例中，目标管59的一端具有半球592的形状，并且引导管52的相应端形成半球凹部。在本发明的一个实施例中，在由运动部57和目标管59形成的球窝连接中，设置在器械5的与支撑压舌板56相同侧的半球凹部571的至少一个边缘575围绕半球的程度比该凹部571的另一个边缘576的小，以允许至少沿基本平行于由支撑压舌板56形成的圆弧方向的方向枢转。
在一个实施例中，杆53为挠性的，并且在其中部横穿球窝连接。于是半球592在其中部具有通道，以允许杆53滑动。该通道至少在设置在器械5的与支撑压舌板56相同侧上的边缘上是中空的。因而，即使当器械5由于球窝连接的枢转处于其倾斜位置中时，如图2C和2D中所示，该通道仍将包括允许杆53滑动经过球窝连接的挖空部593。
在一个实施例中，锁定管58拧(screw)在目标管59上，并且包括使锁定管58旋入的锁定环60。拧入和拧开使锁定管58关于目标管59向前和向后运动。锁定管58向前运动通常导致将锁定管58与运动部57形成接触，结果阻止运动部57枢转。因而，引导管52可以以引导管52和目标管59之间的任何角度关于目标管59被锁定。关于目标管59枢转的运动部57在一个实施例中还可包括至少一个锯齿574，在图3C中具体可见。该锯齿574的存在使运动部57以比运动部直接与锁定管58接触的更大的幅度枢转。该锯齿574允许获得由支撑管52和目标管59之间的倾斜部形成的特定角度。而且，在一个实施例中，该锯齿574可设计成当引导管52与目标管59形成指定角度时，锁定管58的一端的一个边缘锁定到该锯齿574中，如图2A到2D中所示。该锯齿574因此用于阻止枢转，并且用于将器械保持在至少一个位置中，直到其全部由锁定管58的旋入固定。
器械5的操纵端可通常与手柄62装配，以能够操纵器械5，并且通过允许施加到器械5的有效推力，便于椎间融合器移植到椎骨之间。
如前面所述，根据本发明的椎间融合器和器械特别适用于使用经椎间孔入路将椎间融合器移植到两个相邻的椎骨之间。该移植可按照下述进行，但是可能通常存在其他程序变体，并且外科医生可通常根据例如传统使用的技术中的任何改变，在方便时采用本文描述的技术。具体地，本发明可与骨固定物移植物结合使用，通过固定条连接在一起，允许两个相邻椎骨的移动，椎间融合器设计成可插入、消除或限制在所述两个椎骨之间。这些骨固定物移植物可例如包括在由本申请人递交并且以公开号WO02/080788(A1)，WO03/049629(A1)和WO2005/020829(A1)公开或由用于相邻椎骨固定的任何其他类型方式公开的国际专利申请中描述的那些部件。与相邻椎骨的结合相关的步骤特指用于固定相邻椎骨的方式，并且因此在这里不需要描述。
这里仅描述经椎间孔入路移植过程中使用的步骤，以其他方法进行的移植相对类似但是更简单，特别是因为经椎间孔入路需要绕过关节突(articulateprocesses)的事实。用于经椎间孔入路移植的步骤通常以至少一个在脊柱轴侧的切口开始。优选地，沿例如由Dr Wiltse描述的专业外科医生公知的路径形成两个肌间切口。根据所选择的椎间融合器的尺寸和/或根据两个椎骨之间的空间，可实现切除至少部分关节突，以改善进入孔和进入椎间盘空间。这些关节突将于是优选在用于椎间融合器插入侧侧向切除。如果期望关节内移植物(intra-articular graft)，则至少在一侧但是可以在两侧的开口和关节突的再新术(avivement)(软骨去除)将允许至少一个关节内移植物插入。在该步骤过程中，可设计骨固定物移植物的插入以实现固定两个相邻椎骨。这些旋入每一个相邻椎骨中并且由条连接在一起的这些骨固定物移植物在这里允许第一后部分离，以利于进入椎间盘空间。已知类型的工具，例如神经根拉钩(nerve root retractor)(或根管扩张器)可用于保护椎骨根。在环面外层中的侧切口，例如横向关节突之间的侧切口，将提供到椎间盘空间的入口。以已经熟知的方式，开放皮瓣的形成(an open flap)，例如通过绷带固定，将有利于后面的操作。然后外科医生将进行核心和环面中间层的完全去除。将在该步骤使用已知类型的不同工具，例如倾斜的椎间盘夹，刮匙和锉刀(笔直和倾斜的)，以准备椎间盘空间，并且从椎骨板去除软骨而不使其损坏或弱化。
在该步骤过程中，外科医生将轻易地进入椎间盘空间。骨固定物移植物将允许外科医生扩展椎骨，以利于椎间融合器插入。例如，手术将使用旋入椎骨中并且由平行于脊柱轴线的条连接在一起的骨固定物移植物。骨固定物移植物通常包括驱入椎骨中并且形成纵向固定轴的螺钉。在该步骤，骨固定物移植物的这些纵轴彼此不平行，而是在脊柱前面相交。与条的轴线一起，这些轴形成倒置的字母A。于是外科医生将调节骨固定物移植物的跨度。关于这点，外科医生可将扩展管设置在骨固定物移植物的头部上，以尽可能将其扩展，或可使用例如已知类型的分离钳(distraction forceps)。在具有移动头(称为多轴头)的骨固定物移植物的情况下，如在专利申请号WO2005/020829(A1)中公开的，外科医生将于是旋入在条上的这些骨固定物源的头部中，以沿平行于脊柱轴线的条固定其位置。因而由于头部关于条的移动性，植入并且牢固固定在条上的骨固定物移植物将允许进行前部分离。外科医生将压力施加到扩展管，以将其朝向彼此移动，这倾向于在其底部打开倒置的字母A，以使其变成字母H。在具有固定头的骨固定物移植物的情况下，例如在专利申请号WO03/049629(A1)中所描述的，外科医生将使用分离钳来保持骨固定物移植物之间的间距，而无需将这些骨固定物源的头部旋入条上。即使条用在其底部具有球窝连接的固定螺钉固定，如申请WO03/049629(A1)中所公开的，这样的旋入将确实导致骨固定物移植物的头锁定在条上。外科医生因而愿意通过设置在旋入每一个椎骨的两个骨固定物移植物的头部之间的分离钳保持骨固定物移植物之间的间隙。于是，外科医生将压力施加到扩展管，以将其朝向彼此移动，这倾向于在其底部打开倒置的字母A，以使其由于存在分离钳而变成字母H。该操作可能重复几次。例如，在具有多轴头的骨固定物移植物的情况下，该操作可这样重复：通过将骨固定物移植物的头从条旋开，并且将扩展管分离来分离头，然后将移植物的头旋入，并且将扩展管一起拉动来扩展字母H的脚，因而在前面打开椎间盘。该椎间盘空间的前部打开可伴随脊椎前凸(lordosis)的调节。
然后外科医生将进行待移植的椎间融合器的选择，使用具有与设计的将要被移植的椎间融合器相同尺寸的试验椎间融合器。试验椎间融合器放置在器械5上，然后被冲击进椎间盘空间中。压紧应无需过大的力来实现，以不弱化(损坏)椎骨板。试验椎间融合器使用例如拔出小螺帽(或提取器或去除螺帽或铅锤)等已知类型的工具去除，并且该操作可重复，直到已经形成满意的尺寸。
于是可通过将压舌板56的端部55插入椎间融合器的弯折孔32中，并且关于压舌板56移动主体1的圆弧，直到将销54锁定到端壁14的凹部31内，来将最终的椎间融合器放置在移植器械5上。椎间融合器于是通过进入端孔30中的滑动杆53锁定在器械5上。器械在其远端的关节通过运动部57允许建立用于将椎间融合器接合在椎间空间中的最适当的角度。该角度可例如通过销扳手等已知类型的工具，用螺纹环60旋入锁定管58来锁定。因而固定在器械上并且以最佳方式定向的椎间融合器可于是压紧在椎骨之间。椎骨融合器将优选在圆形运动中尽可能在前面压紧。为了优化椎间融合器的位置，由运动部57形成的关节角度可在压紧过程中调节，通过锁定环60谨慎地正确锁定该角度。在椎间盘空间中的椎间融合器的位置和方向可于是通过已知类型的x射线例如亮度放大器证实。实际上，在一个实施例中，椎间融合器包括至少一个辐射不透明标记(radio-opaque marker)，其将由亮度放大器检测到。然后外科医生可根据该一个或多个标记的位置和方向调节椎间融合器的位置。当椎间融合器已经正确移植时，其将通过沿操纵端方向移动滑动杆53从器械5卸下。于是外科医生仅需将骨移植物或替代物设置在椎间融合器(优选放置在椎骨板前边缘高度处)和髓腔之间。关于这点，外科医生将使用已知类型的工具，例如压舌板。在环面外层中形成的折片(flap)可于是闭合并且缝合，以将移植物保持在位。例如后外侧类型的移植物可在该步骤实现，以优化与椎骨结合在一起。然后移植物将放置在例如横向关节突上。于是引流管(redon)可能放置在位，并且皮下缝合后跟随切口的皮肤缝合将使手术过程结束。
对本领域技术人员显而易见的是，本发明允许任何其他特定形式的实施例而不超出所要求的本发明的精神和范围，并且允许包括在本文中的非排他性实施例的任意组合。因此，本实施例应仅被认为是示例性的，但是可在由所附权利要求的范围限定的范围内进行改进，并且本发明不限于上面给出的详细内容。

Claims (40)

1.一种用于椎间融合移植物的椎间融合器，包括主体，通常形成弧形，所述主体包括：侧凹入表面；侧凸出表面；基本上横向的上表面；基本上横向的下表面；端壁，在所述主体的第一纵向末端，所述端壁包括端孔，构造用于容纳移植器械的杆的保持端，并且定向为基本上正切于由所述主体形成的弧形；和向内弯曲的弯折部，位于所述主体的第二纵向末端并与所述端壁相对。
2.根据权利要求1所述的椎间融合器，其中，所述端壁包括凹部，该凹部构造用于容纳移植器械的销。
3.根据权利要求1所述的椎间融合器，其中，所述弯折部包括弯折孔，该弯折孔定向为基本上正切于由所述主体形成的弧形，并且构造用于容纳移植器械的端部。
4.根据权利要求3所述的椎间融合器，其中，所述端壁包括凹部，该凹部构造用于容纳移植器械的销，所述端孔、所述凹部和所述弯折孔构造用于分别与移植器械的杆的保持端、销和端部配合，以确保通过移植器械抓握椎间融合器。
5.根据权利要求1所述的椎间融合器，其中，所述主体的上表面和下表面中的至少一个表面包括锯齿，该锯齿定向成能够阻止椎间融合器跟随椎间融合器的椎间移植而运动。
6.根据权利要求1所述的椎间融合器，其中，所述弯折部包括上表面和下表面，该上表面和下表面分别延伸所述主体的上表面和下表面，所述弯折部的上表面和下表面中的至少一个表面包括锯齿，该锯齿构造成能够阻止椎间融合器跟随椎间融合器的椎间移植而运动。
7.根据权利要求1所述的椎间融合器，其中，所述弯折部包括上表面和下表面，该上表面和下表面分别延伸所述主体的上表面和下表面，所述弯折部的上表面和下表面中的至少一个表面包括倒角，该倒角构造成有利于所述椎间融合器的椎间移植。
8.根据权利要求5所述的椎间融合器，其中，所述主体的所述第一和第二纵向末端形成所述椎间融合器的纵轴，并且至少一些锯齿定向为基本上平行于所述椎间融合器的纵轴。
9.根据权利要求5所述的椎间融合器，其中，所述主体的所述第一和第二纵向末端形成所述椎间融合器的纵轴，并且至少一些所述锯齿定向为基本上垂直于所述椎间融合器的纵轴。
10.根据权利要求5所述的椎间融合器，其中，所述主体的所述第一和第二纵向末端形成所述椎间融合器的纵轴，并且至少一些锯齿关于基本上垂直于所述椎间融合器的纵轴的轴线以波浪形结构布置。
11.根据权利要求5所述的椎间融合器，其中，所述主体的所述第一和第二纵向末端形成所述椎间融合器的纵轴，并且至少一些锯齿形成同心圆弧，每一个同心圆弧关于基本上平行于所述椎间融合器的纵轴的对称轴而对称于由所述主体形成的圆弧。
12.根据权利要求5所述的椎间融合器，其中，至少一些所述锯齿定向为基本上法向于由所述主体形成的弧形。
13.根据权利要求5所述的椎间融合器，其中，在所述椎间融合器的上表面或下表面上的所有锯齿具有基本上相同的方向。
14.根据权利要求5所述的椎间融合器，其中，在所述椎间融合器的上表面或下表面上的一些锯齿不具有与在所述椎间融合器相同表面上的其他锯齿相同的方向。
15.根据权利要求5所述的椎间融合器，其中，在所述椎间融合器的上表面和下表面的每一个表面上的锯齿具有相同的方向。
16.根据权利要求5所述的椎间融合器，其中，在所述椎间融合器的上表面上的锯齿具有不同于所述椎间融合器的下表面上的锯齿的方向。
17.根据权利要求1所述的椎间融合器，其中，所述主体包括辐射不透明标记，该辐射不透明标记构造用于以x射线图像来标识所述椎间融合器。
18.根据权利要求1所述的椎间融合器，其中，由所述椎间融合器的上表面和下表面形成的平均平面基本上彼此平行。
19.根据权利要求1所述的椎间融合器，其中，由所述椎间融合器的上表面和下表面形成的平均平面形成能够矫正脊柱缺陷的角度。
20.根据权利要求1所述的椎间融合器，其中，所述椎间融合器的表面的至少一个表面包括至少一个能够使骨移植物或替代物生长的开口。
21.根据权利要求1所述的椎间融合器，其中，至少一个切口经过所述椎间融合器的所述主体，并且形成从所述椎间融合器的表面的至少一个表面延伸到另一个表面的管道，所述切口构造成用于容纳固定物，所述固定物包括被冲击进椎体内的平直固定物板，所述椎间融合器与所述平直固定物板相接触。
22.一种用于椎间融合移植物的椎间融合器移植的器械，所述用于椎间融合移植物的椎间融合器包括通常形成弧形的主体，所述主体包括侧凹入表面；侧凸出表面；基本上横向的上表面；基本上横向的下表面；在所述主体第一纵向末端处的端壁，所述端壁包括定向为基本上正切于由所述主体形成的所述弧形的端孔；所述器械包括：
杆，包括保持端，该保持端构造成用于插入所述端孔中；
抓握端，用于抓握所述椎间融合器，所述抓握端包括：
支撑压舌板，包括底部，并且通常形成与由所述主体形成的弧形互补的弧形；
引导管，所述杆可滑动地布置其中，并且所述支撑压舌板的底部安装到其上，所述引导管包括开口，所述杆的保持端可穿过所述开口，用于插入所述端孔中；和
操纵端，用于控制所述器械。
23.根据权利要求22所述的器械，其中，所述杆基本上延伸到所述器械的操纵端附近。
24.根据权利要求22所述的器械，其中，所述器械包括按钮和凹槽，该按钮连接到所述杆，该按钮从该凹槽突出，所述按钮构造成用于滑动所述杆以关于所述引导管中的开口调节所述杆的保持端的位置。
25.根据权利要求22所述的器械，其中，所述引导管包括销，该销构造成用于接合布置在所述椎间融合器的端壁上的凹部。
26.根据权利要求22所述的器械，其中，所述支撑压舌板包括远离所述底部的端部，所述端部构造成用于插入布置在所述椎间融合器的向内弯曲的弯折部上的弯折孔内，所述弯折孔定向为基本上正切于由所述主体形成的弧形。
27.根据权利要求26所述的器械，其中，所述引导管包括销，该销构造成用于接合布置在所述椎间融合器的端壁上的凹部，所述杆的所述保持端、所述销和所述移植器械的所述端部构造成分别与所述端孔、所述凹部和所述弯折孔配合，以确保通过所述移植器械抓握所述椎间融合器，并且有利于通过从所述端孔拆卸所述杆的保持端而在所述椎间融合器移植后撤出所述器械。
28.根据权利要求22所述的器械，还包括目标管，该目标管基本上延伸到所述器械的操纵端附近，其中，所述引导管包括运动部，该运动部关于所述目标管至少在主要枢转方向上枢转，所述主要枢转方向基本上位于由所述支撑压舌板形成的弧形所处的平面内，并且所述移动部关于所述目标管的位置形成枢转角。
29.根据权利要求28所述的器械，其中，所述移动部或所述目标管中的一个包括基本上半球状的端部，并且所述移动部或所述目标管的另一个包括具有形状和尺寸与所述半球状端部的形状和尺寸互补的凹入端，所述半球状端部和所述凹入端分别构成为球窝连接的球部件和窝部件。
30.根据权利要求29所述的器械，其中，所述窝部件包括开口边缘部，所述开口边缘部中的一个开口边缘部靠近所述支撑压舌板，并且构造成围绕所述球部件小于其他开口边缘部，以使所述移动部关于所述目标管至少在主枢转方向上进一步枢转。
31.根据权利要求29所述的器械，其中，所述杆为挠性杆，并且通过设置在所述球部件和所述窝部件中心处的通道可滑动地穿过球窝连接，所述通道具有靠近所述支撑压舌板的中空部，所述中空部构造成甚至当所述运动部关于所述目标管枢转时所述杆仍滑动穿过所述球窝连接。
32.根据权利要求28所述的器械，其中，所述器械还包括可滑动地沿所述目标管布置的锁，所述锁具有向前位置，并且构造成当所述锁布置在向前位置中时以所选枢转角度固定所述引导管的所述运动部。
33.根据权利要求32所述的器械，其中，所述运动部包括锯齿，该锯齿构造成用于增加最大枢转角，所述引导管的所述运动部以所述最大枢转角可由所述锁固定，并且该锯齿还构造成用于提供预定的枢转角。
34.根据权利要求33所述的器械，其中，所述锯齿构造成用于与所述锁接合，而无需将所述锁布置在向前位置中，所述接合建立预定的枢转角，并且防止所述运动部枢转。
35.根据权利要求22所述的器械，其中，所述器械的操纵端包括手柄，该手柄构造成可操纵所述器械，并且有利于所述椎间融合器在所述椎骨之间的移植。
36.一种用于将椎间融合移植物的椎间融合器移植到脊柱的相邻椎骨之间的椎间盘空间内的方法，所述椎间盘空间包括环面和核心，所述方法包括以下步骤：
提供一种用于椎间融合移植物移植的椎间融合器，所述椎间融合器包括总体上形成弧形的主体，所述主体包括：
侧凹入表面，
侧凸出表面，
基本上横向的上表面，
基本上横向的下表面，
端壁，该端壁在所述主体的第一纵向末端处，该端壁包括端孔，该端孔构造用于容纳移植器械的杆的保持端，并且定向为基本上正切于由所述主体形成的弧形，和
向内弯曲的弯折部，该弯折部在所述主体的第二纵向末端处并与所述端壁相对，该弯折部包括弯折孔，该弯折孔定向为基本上正切于由所述主体形成的弧形并且构造成用于容纳移植器械的端部；
提供一种器械，包括：
杆，该杆包括保持端，该保持端构造成用于插入所述端孔中，
抓握端，用于抓握所述椎间融合器，所述抓握端包括支撑压舌板，所述支撑压舌板包括底部，并且通常形成与所述主体形成的弧形互补的弧形，所述支撑压舌板包括远离所述底部的端部，该端部构造成用于插入所述椎间融合器的弯折孔内，和
引导管，所述杆可滑动地布置其中，并且所述支撑压舌板的底部安装到其上，所述引导管包括开口，所述杆的所述保持端可穿过所述开口，用于插入所述端孔中；和
操纵端，用于控制所述器械；
形成切口来进入脊柱；
切入环面，并且从椎间盘空间去除核心；
将所述压舌板的端部插入到所述椎间融合器的所述弯折孔中；
将由所述主体形成的弧形靠近由所述压舌板形成的弧形布置；
通过将所述杆的保持端插入所述端孔中将所述椎间融合器固定在所述器械上；
将所述椎间融合器布置在弧形运动中的椎间盘空间中；
通过从所述端孔卸下所述杆的保持端将所述椎间融合器从所述器械释放；
将所述器械从所述椎间盘空间去除；以及
缝合环面和皮肤。
37.根据权利要求36所述的方法，其中，将所述椎间融合器布置在所述椎间盘空间中的所述步骤继续或伴随有将所述器械的运动部关节连接为所选角度的步骤，之后跟随有将所述运动部以所选角度锁定的步骤。
38.根据权利要求36所述的方法，其中，在将所述椎间融合器布置在所述椎间盘空间中的步骤之后跟随有通过使用x射线检测包括在所述椎间融合器的主体中的辐射不透明标记来确定所述椎间盘空间中椎间融合器的位置和方向，并且如果这样的位置或方向不正确，则调整所述椎间盘空间中的所述椎间融合器的位置或方向的步骤。
39.根据权利要求36所述的方法，其中，在将所述压舌板的端部插入所述椎间融合器的弯折孔中和将由所述主体形成的弧形靠近由所述压舌板形成的弧形布置的步骤之后跟随有将所述器械的销与布置在所述椎间融合器端壁上的凹部接合的步骤，并且在通过将所述杆的保持端插入到所述端孔将所述椎间融合器固定在所述器械上的步骤之后，继续进行将所述器械的销与布置在所述椎间融合器端壁上的凹部接合的步骤。
40.根据权利要求36所述的方法，其中，在将所述椎间融合器布置在所述椎间盘空间中的步骤后，进行将所述相邻的椎骨分离的步骤。
CN200780008095XA 2006-02-15 2007-02-15 用于椎间融合移植物的经椎间孔椎间融合器和用于移植椎间融合器的器械 Expired - Fee Related CN101394814B (zh)

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US20090222092A1 (en) 2009-09-03
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US20120310356A1 (en) 2012-12-06
CN101394814B (zh) 2012-08-22
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US20180008430A1 (en) 2018-01-11

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