CN1925799A - 人工脊椎盘植入器械及方法 - Google Patents

人工脊椎盘植入器械及方法 Download PDF

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Publication number
CN1925799A
CN1925799A CNA2004800326725A CN200480032672A CN1925799A CN 1925799 A CN1925799 A CN 1925799A CN A2004800326725 A CNA2004800326725 A CN A2004800326725A CN 200480032672 A CN200480032672 A CN 200480032672A CN 1925799 A CN1925799 A CN 1925799A
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China
Prior art keywords
groove
guide
intervertebral disc
disc space
hole
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Granted
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CNA2004800326725A
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English (en)
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CN1925799B (zh
Inventor
G·C·马利克
C·M·斯奎雷斯
C·S·威廉姆斯
T·A·兹德布利克
V·C·特雷纳利斯
R·W·海德
B·J·考茨
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SDGI Holdings Inc
Warsaw Orthopedic Inc
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Warsaw Orthopedic Inc
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Abstract

一种椎间盘间隙制备导向装置，该装置包括具有第一凹槽的间隔部分和具有第一通孔的第一加工导向件。第一通孔对准第一凹槽，并适于接受第一骨去除机构。

Description

人工脊椎盘植入器械及方法
背景
本发明涉及人工脊椎盘以及与人工脊椎盘的植入相关的器械和方法。
目前治疗有问题的脊椎盘的脊椎疗法是从例如用杆或板将跨过问题盘间隙的相邻椎骨的刚性固定，发展到例如用人工脊椎盘来维持相邻椎骨的相对运动。例如，可采用人工脊椎盘治疗变性盘疾病，包括髓核脱出和/或后骨赘，导致神经根病和/或脊髓病。神经根病压迫脊神经根，而脊髓病压迫脊髓。两种病症都可导致个体手臂、腿、背和/或颈的疼痛或麻刺感。
现有人工脊椎盘在固定于相邻椎骨以及植入后的修正、除去能力方面不理想。例如，需要对现有人工盘的外形进行特殊处理以***相邻椎骨终板。而且，现有人工盘要求特殊处理椎骨和/或植入器械以容纳刺突、鳍片或用于将盘固定于椎骨的延伸入相邻椎骨的其它结构。此外，现有人工盘可包括横跨整个椎骨接触表面的骨向内生长表面。这就会使一旦植入了人工盘后就难以除去人工盘(有时需要)。
类似地，相关植入器械和方法具有与用于脊椎较敏感区域如颈椎的复杂性或稳定性相关的许多缺点。例如，某些植入***需要使用许多不同器械或装置来制备盘间隙和正确***人工盘。而且，某些植入***依赖于将诸装置撞击、捶打入骨以容纳人工盘。这种撞击技术在某些脊椎区域(如腰椎中)合适，但在其它脊椎区域(如颈椎)则不合适，因为颈椎接近脊髓和神经根而要求更精密的操作措施。
发明概述
在一个实施方式中，椎间盘间隙制备导向装置包括具有第一凹槽的间隔部分和包括第一通孔的第一加工导向件。第一通孔和第一凹槽对准，并且适于接受第一骨去除机构。
在另一个实施方式中，椎间盘间隙制备导向装置包括***椎间盘间隙的间隔部分和设置在椎间盘间隙外的切割导向装置。第一切割导向装置包括第一和第二侧。椎间盘间隙制备导向装置还包括延伸通过切割导向装置第一侧的第一导向通孔。第一导向通孔适于接受第一骨去除机构。
在另一个实施方式中，给出了一种在一对椎骨终板间制备椎间盘间隙以接受植入物的方法，该方法包括选择导向组件。导向组件包括间隔部分和导向部分。该方法还包括将间隔部分***椎间盘间隙中。间隔部分包括位置邻近第一块椎骨终板的第一凹槽。该方法还包括使骨去除器械通过导向部分中的第一通孔并进入间隔部分中的第一凹槽，以及在邻近第一凹槽的第一椎骨终板中形成第一通道。
附图简要说明
下面将结合附图描述本发明的各种实施方式，提供附图是为阐述而不是限制本发明，图中相似标号表示相似元件，其中：
图1是人工脊椎盘***的立体图；
图2是图1人工脊椎盘***的前视图；
图3是图1人工盘***第二或次级构件的仰视图；
图4是图1人工盘***第一或初级构件内表面的立体图；
图5图1人工盘***第二或次级构件内表面的立体图；
图6图1人工盘***第一或初级构件内表面的仰视图或底视图；
图7图1人工盘***第二或次级构件内表面的仰视图或底视图；
图8另一种人工脊椎盘***的后视图；
图9是沿图8人工盘***线9-9的截面图；
图10是植入人工脊椎盘***的方法流程图；
图11表示处于脊柱手术位置的患者，包括形成通到自身固有脊椎盘和相邻椎体的进入通道的方法；
图12表示除去图11自身固有脊椎盘的方法；
图13-14表示在图11相邻椎体的一个或两个终板中形成预定外形的方法；
图15表示根据图13-14方法制备的盘间隙；
图16表示确定所制备的图15的盘间隙的尺寸；
图17-18表示导轨切割导向装置以及在一个或两个邻近所制备的图15的盘间隙的终板中形成一个或多个鳍片或导轨导向通道的方法；
图19-20表示与图17-18导轨切割导向装置联用的骨去除机构；
图21表示使用临时固定构件将导轨切割导向装置相对于一个或多个相邻椎骨临时固定；
图22表示所制备的图15的终板的盘间隙，并带有通过图17-21方法形成的鳍片或导轨导向通道；
图23是用于使盘***保持和***图22的盘间隙中的人工脊椎盘***和植入物***器的立体图。
图24是表示将人工脊椎盘******图22盘间隙的方法的立体图；
图25是将植入物***器从图24植入的人工脊椎盘***除去的方法的立体图；以及
图26是包含植入图22盘间隙中的人工脊椎盘的脊柱一部分的前视图。
发明详述
本发明涉及人工盘***、以及与将这些盘***植入脊柱有关的方法和装置。人工盘***的一个例子是美国专利6,113,637所述***，其内容被纳入本文作为参考。人工盘***提供预先确定的骨向内生长区域，以允许植入后修正或去除人工盘。而且，人工盘***还包括在进行上述修正时可改善器械可到达性的结构装置。此外，人工盘***包括在有关椎骨中稳定盘的结构。并且，相关器械和装置可简化人工盘***的植入，并使******盘间隙的创伤较小。
参见图1-3，人工脊椎盘***10的有关实施方式包括通过铰接组件17相对于第二构件14可运动的第一构件12。第一和第二构件12，14各自包括至少一个骨接触表面16，18以抵靠相邻椎骨的一部分。骨接触表面16，18可各自包括至少一个在各自表面16，18上预定位置和取向、预定尺寸和形状的骨向内生长表面20，22。骨向内生长表面20，22的预定尺寸、形状、位置、取向允许所计算的量的骨生长进入盘构件12，14，以确保固定于相邻骨，同时又容易在骨向内生长后从相邻骨除去盘构件(如果由于医疗需要改变而要求除去的话)。而且，骨向内生长表面20，22的上表面24，26在骨接触表面16，18其余部分的上方可具有预定间隔28，30(图2)，以使通过植入人工盘***10提高相邻椎骨穿透和/或压制入骨向内生长表面20，22。此外，构件12，14可各自包括至少一个骨向内生长区域指示结构32，34，该指示结构可识别骨向内生长表面20，22的位置。例如，植入人工盘***10后，骨向内生长区域指示结构32，34提供可通过肉眼观察的视觉标识，例如通过暴露***10表面的切口，或通过医疗诊断设备如X射线、超声、核磁共振、计算机断层摄影、正电子发射技术和其它诊断技术。而且，骨向内生长区域指示结构32，34还可包括在除去人工盘***10中与诸如骨凿之类的医疗器械联用的器械进入导向件36，38。器械进入导向件36，38将器械导引至骨向内生长表面20，22的正确位置，从而避免在非骨向内生长区域中的不必要工作，而不干扰表面16，18上的其它结构。因此，人工盘***10具有用于牢固地固定于相邻椎骨、同时又容易除去整个***或***的一部分(如果后来由于医疗需要改变而要求的话)的装置。
骨向内生长表面20，22通常尺寸大大小于各自的骨接触表面16，18的总尺寸。而且，骨向内生长表面20，22可位于各自的骨接触表面16，18上，从而使得植入后骨向内生长表面20，22的位置邻近相邻椎骨的松质骨部分，而不是皮质骨部分。例如，对于基本上横跨盘间隙或椎骨终板的盘***，这种定位可在构件12，14的中心。或者，如果盘***仅仅横跨盘间隙或椎骨终板的一部分，上述定位可偏离构件12，14的中心。此外。植入***10后暴露的骨向内生长表面20，22的位置也可离开构件12，14的边缘44，46，例如不在相邻椎骨间的盘间隙中的边缘。预定间隔40，42使得诸如骨凿之类的器械例容易进入，该器械用于在骨向内生长发生后从椎骨上分离开构件12，14。而且，骨向内生长表面20，22也可位于单一表面中，或者如果需要更牢固的固定和骨向内生长时、可位于一个或多个相互交叉的表面中。合适的骨向内生长表面20，22的例子可包括以任何方式或用允许骨生长和结合的任何材料来化学蚀刻、处理、喷雾、层压、融合、涂覆或织造的表面。
骨向内生长指示结构32，34可包括在构件12，14任何表面上的任何类型的标记，例如压痕、嵌入标记、涂覆、凸起等。而且，器械进入导向件36，38可包括与用于从骨分离开构件12，14的医疗器械的表面或一部分联用的任何表面或表面的组合。或者，器械进入导向件36，38可包括一标记以在计算机和/或图片引导外科中指示位置。
而且，参见图2，通过将骨生长促进物质49施加于人工盘***的骨接触表面16，18，可更加牢固地将人工盘***10固定于骨。具体地说，可将骨生长促进物质49施加于一个或多个骨向内生长表面22以促进骨向该区域生长。骨生长促进物质合适的例子包括骨形态形成蛋白质(“BMP”)、LIM矿化蛋白(“LMP”)、脱矿骨基质(“DBM”)、间充质干细胞、血小板凝胶和其它类似材料。
铰接组件17可以是与第一构件12和第二构件14中的一个或两个整合的结构，或是独立的结构。例如参见图4-7，在一个实施方式中，铰接组件17包括关节48，它至少部分具有凸形或曲线表面50，例如基本上球形，从第一构件12突出而在第二构件14中所形成的、至少部分凹陷或曲线表面52(如伸长的槽)中可活动。或者，铰接组件17可以是完全独立的构件或是诸如球、盘、核、柔性和/或弹性构件等之类的组合，它可与第一和第二构件12，14组合设置，以允许在第一和第二构件之间相对旋转和/或平移。而且，第一和第二构件12，14及连接构件17可相互连接形成单元组件。
另外，人工盘***10可包括至少一个从第一或第二构件12，14的骨接触表面16，18突出的鳍片或导轨构件54。鳍片或导轨构件54提供表面56，58，它们与对抗构件12，14在表面16，18的平行平面中相邻椎骨内的平移或旋转运动的骨接触表面16，18基本垂直。然而，应理解可调节表面56，58的具体取向以抵抗在任何所需平面或取向中的相对运动。此外，鳍片或导轨构件54可包括顶部啮合表面60，例如形成齿、滚花、纹理等以进一步抵抗构件12，14在骨中的移动。例如，对于从前侧***盘间隙的人工脊椎盘***10，顶部啮合表面60可通过使骨在顶部啮合表面之间内侧方向中生长或定位、来抵抗植入盘在前侧方向中的运动。可对表面60取向以抵抗构件12，14与骨之间相同平面(如表面56，58)不同方向的相对运动。然而，应注意，可对表面56，58和60取向而成为可抵抗任何相对运动方向的组合。此外，顶部啮合表面60以及表面56，58可形成为带有倾斜或其它偏倚的表面，这些表面在一个或多个所需方向上可有更大的阻力。例如，顶部啮合表面60可包括许多由至少两个表面所形成的齿，其中至少一个表面与骨接触表面16，18基本垂直，而另一个表面与骨接触表面16，18基本非正交倾斜。
其它鳍片或导轨构件54沿平行于***方向的直线取向，***方向是指将人工脊椎盘相同10或各个独立构件12，14***相邻椎骨之间的位置的方向。然而，应理解鳍片或导轨构件54可沿曲线设置，并可相对于***方向倾斜。此外，鳍片或导轨构件54可以是任何预定的长度。例如，鳍片或导轨构件54的长度可大于或小于人工脊椎盘***10总的两边缘间的长度。例如，鳍片或导轨构件54的长度可为从盘***10的任何一个边缘隔开，或鳍片或导轨构件的一端或两端可基本上与盘***的边缘相平行。当鳍片或导轨构件54的端部平行于盘***10的边缘(如暴露的边缘44，46)时，那么鳍片或导轨构件可用作骨向内生长指示结构32，34和/或器械进入导向件36，38。
此外，人工脊椎盘***10可包括允许盘***结合***器械的翼片62或其它纵向延伸构件。例如，翼片62可包括一个或多个对应于***器械上啮合装置的连接结构64(图2)，例如形成空腔或洞的内壁，该***器械用于保持和/或***一个或两个构件12，14。或者，连接结构64可包括延伸入***器械对应的洞或空腔中的凸起。而且，翼片或延伸构件62可防止构件12，14相对于植入后重叠骨的运动。例如，对于从前侧***相邻椎骨间的盘***10，翼片或延伸构件62远离盘间隙伸出并超过椎体前部，从而防止构件12，14沿后路方向的相对运动。
第一构件12、第二构件14和铰接组件17各自可由一种或多种不同生物相容材料的任何组合形成。合适的材料包括不锈钢、钴铬、钛、橡胶、弹性体、聚合物等，包括所有合金和这些材料的变异体。
参见图8和9，在另一个实施方式中，人工脊椎盘***70包括可相对于第二构件72运动的第一构件12，这种运动在至少一个方向中具有预定的运动范围74，大于要替代的自身固有盘的自身固有运动范围76。例如，在一个实施方式中，铰接组件17包括与凹面52相互作用的凸面50，凹面52相对于前-后平移可具有的预定运动范围74要大于要替代的自身固有盘的前-后平移的自身固有运动范围。例如，对于一般对应于脊椎活动区段屈伸运动的脊椎盘前-后平移，这种移动通常被自身固有组织，包括肌肉、腱、纤维环和/或关节面限制。因此，在盘***70中不需要提供限制第一构件12和第二构件72运动的物理限制，因此铰接组件17，作为邻近植入的人工脊椎盘***70的自身固有组织结构，可自然而然地限制盘***的相对运动。应理解，预定的运动范围74可以是一个或多个方向或平面的任何组合，可完全覆盖自身固有运动范围76，向自身固有运动范围的一侧偏倚，或在一侧内但延伸超出自身固有运动范围的另一侧。此外，虽然不是必需的，人工脊椎盘***70还可包括位于自身固有运动范围76之外的安全止挡件78，以最终限制第一构件12相对于第二构件72的运动。安全止挡件78可形成在第一构件12、第二构件72或铰接组件17中。
参见图10，植入人工脊椎盘***方法的实施方式包括进行预操作设计(模块80)，除去存在的自身固有盘(模块82)，制备椎间盘间隙以接受人工盘***(模块84)，***和固定人工盘***(模块86)。预操作设计的步骤包括检查患者，拍摄X光片或进行其它诊断步骤以分析有问题的自身固有盘，分析和/或计算脊椎运动区段的存在或自身固有运动范围，和/或测定有问题的自身固有盘以确定人工盘***合适的尺寸。除去自身固有盘的步骤包括诸如椎间盘去除或部分椎间盘去除之类的手术，或任何其它除去所有或部分自身固有盘髓核的手术。制备椎间盘间隙以接受人工盘***的步骤包括修整相邻椎骨终板的外形。这种外形修整包括在终板中形成平行表面、形成凹面、或形成任何其它形状，以接受人工盘***。具体地说，如下文更详细描述的那样，修整终板外形的步骤还包括加工形成至少一个鳍片或导轨开口以接纳对应的至少一个人工盘***的鳍片或导轨构件。加工步骤包括使用具有适合除去骨表面的工具从终板除去骨槽，其中工具能够在终板上旋转、振动、往复或其它操作以除去骨。并且，***或固定人工盘***的步骤可包括夹持单一组件或整个组合的人工盘***并将其移入准备好的椎间盘中直到它到达预定的所需位置为止。人工盘***的固定可由于横跨植入的人工盘***的压迫力而自然而然地形成，或可由于修整终板外形来形成，或可由于诸如应用螺钉或其它组件以将***组件固定于椎骨的补充固定技术来形成，或是由这些技术的某种组合来形成。而且，通过将骨生长促进物质施加于人工盘***的骨接触表面可进一步达到人工盘***的固定。骨生长促进物质合适的例子包括骨形态形成蛋白质(“BMP”)、LIM矿化蛋白(“LMP”)、脱矿骨基质(“DBM”)、间充质干细胞、血小板凝胶和其它类似材料。应理解的是，可通过开放的外科部位，或以最小侵入性的方式、例如可通过患者的皮肤和组织中比开放式手术小的开口管或通道来实现上述方法。
参见图11-26，将人工脊椎盘***植入颈椎部分的方法的一个实施方式包括：使患者位于手术位置，进行椎间盘去除或减轻盘间隙的压力，准备相邻的椎骨终板，以及***人工脊椎盘。参见图11，定位患者90使其颈部92对应于自身固有颈椎脊柱前凸的中性位。制备切口后，通过诸如一个或多个牵开器刀片或内窥镜入口或通道之类的开启机构102来维持到达自身固有脊椎盘96和/或相邻椎骨98，100的进入通道94，开启机构各自的例子包括Medtronic Sofamor Danek USA(Memphis，TN)生产的TRIMLINE牵开器刀片或X-TUBE内窥镜入口。然后，参见图12，使用诸如刮匙、骨凿或为除去全部或一部分自身固有盘而特殊设计的任何器械之类的盘去除器械104来去除自身固有脊椎盘96。去除全部或一部分自身固有脊椎盘96之后，例如通过使用Smith-Robinson减压技术，减轻盘间隙的压力。
参见图13-15，去除自身固有盘之后，即椎间盘去除和减压后，采用至少一个外形修整装置106，以在相邻椎体98，100的一个或两个中形成通常对应于人工盘骨接触表面的预定外形108，110。例如，在一个实施方式中，例如通过使用圆柱形磨石来将椎骨终板加工成平面。然而，应理解的是，可使用诸如铣刀、铰刀、锯子等和其它预定的成形装置之类的其它外形修整装置106来从终板除去骨。为避免人工盘***陷入终板，可进行加工以保存尽量多的皮质骨。此外，具体参见图13，应理解，可与外形修整装置106联合使用诸如支架或标记之类的参照装置112来控制或引导外形修复装置的运动。例如，可将参照装置112与一个两个相邻椎骨98，100结合，用以提供外形修整装置106的几何学指导。终板外形修整完成后，就可将制备盘间隙114(图15)准备，以用于盘***，并可除去所有外部分离物。
参见图16，为确定使用的人工盘的合适尺寸，***植入物试件116以确定制备的盘间隙114的尺寸。在一些需要避免对人工盘***过度压迫力的实施方式中，适当尺寸的植入物试件116紧密适配于制备的盘间隙114中但不分离相邻椎骨98，100。此外，可诊断性地用例如荧光检查法来证实植入物试件116的匹配。参见图17，一旦确定适当尺寸的植入物试件116后，则选择相应大小的导轨切割导向装置118，用于在终板中制备一个或多个与人工盘***上的鳍片或导轨构件相应的鳍片或导轨通道。
参见图17-22，导轨切割导向装置118的一个实施方式包括至少一个位于导向主体122上的加工导向件120，其尺寸124可给骨切割装置126提供参照，以在一个或两个相邻椎骨98，100中形成与人工脊椎盘***上的鳍片或导轨导向构件的位置和尺寸相应的鳍片或导轨构件通道128。在具有一个以上加工导向件120的实施方式中，具体参见图19，每个加工导向件120相对于一个或多个其它加工导向件具有预定的纵向间隔121和/或预定的横向间隔123。这种预定间隔121，123有利于确保在一个椎骨终板或在相邻的终板中形成至少两个鳍片或导轨构件通道128(图22)，它们与选定要植入的人工脊椎盘上至少两个或多个鳍片或导轨构件的预定间隔对准。而且，导轨切割导向装置118可包括间隔部分130，其尺寸和厚度132(图20)与所需盘间隙例如制备的盘间隙114的自身固有中性盘间隔相应。此外，导向主体122或间隔部分130可包括预定的凹槽131，其尺寸可容纳至少一部分骨去除装置。导轨切割导向装置118还可包括永久性或可移去的可结合手柄134，用以操纵导向件的位置。具体参见图17，导轨切割导向装置118还可包括与推动机构138(例如锤子状或重量运动型装置)相互作用的啮合结构136(例如凸起或伸长)，用于将导向件118移入适当位置。可以不用或者除了参照制备的盘间隙114和/或通过间隔部分130而相邻椎骨98，100外，导轨切割导向装置118可包括一个或多个参考标记140，以确保相对于相邻椎骨的所需定位。例如，所需定位可包括头-尾定位、侧向定位、制备的盘间隙114内的深度定位及其任何组合。例如，参考标记140可包括从导向主体122伸出的限制结构142，用以限制导向主体穿透进入制备的盘间隙114的深度。而且，一个或多个参考标记140可与具有一相对于一个或两个椎骨98，100和/或制备的盘间隙114已知位置的任何其它结构结合起来。
再参见图17，为相对于相邻椎体98，100定位导轨切割导向装置118，可采用推动机构138来将导轨切割导向装置118移入所需位置。例如，在一个实施方式中，敲击导轨切割导向装置118直到所有的限制结构142遇到相邻椎骨98，100的前侧为止。参见图19-22，移去推动机构138之后，骨去除机构144可相对于加工导向件120移动，以形成鳍片或导轨构件通道128(图22)。例如，在一个实施方式中，骨去除机构144可包括钻头146，它可与一个诸如电源的制动机构148或者是一个手动钻手柄结合。在该实施方式中，将钻头146***形成在导轨切割导向装置118上加工导向件120中的一个入口中，进行操作以在终板中形成一个通道128。具体参见图21，需要确保导轨切割导向装置118和首先形成的通道128(未示出)的相对位置，以保证连续通道正确的几何学对准。在这种情况下，可将临时固定机构150(如销或螺钉)固定于导轨切割导向装置118(例如加工导向件120)。然后，可形成连续的通道128，还可采用其它临时固定机构150。具体参见图22，移去任何临时固定机构150和导轨切割导向装置118后，一个或两个终板应具有一个或多个正确定位的通道128。
参见图23-26，可将人工脊椎盘***10或70(例如Medtronic SofamorDanek USA(Memphis，TN)生产的PRESTIGE Cervical Disc)结合到植入物***器152上。例如，在一个实施方式中，植入物***器152包括四个***叉154(图23中只能看到3个)，结合到位于外鞘156中的腿155上，与翼片62中的洞64相匹配。将外鞘156向前推以施加横跨叉154的力，而保持盘***10或70。使一个或多个鳍片或导轨构件54对准相邻椎骨98，100终板上的一个或多个通道28，盘***10或70***终板的盘间隙114中。可通过推动机构138帮助***，并将盘***10或70向前推直到前侧位置的翼片62接触相邻椎体98，100的前侧为止。然后通过植入物***器152(例如，通过向后滑动外鞘156和小心移去植入物***器152)来松开盘***10或70。可用诊断设备如用荧光检查法来证实盘***10或70最终置于相邻椎骨98，100之间。可用标准闭合手术来完成外科手术过程。
因此，本发明包括多种实施方式的具有预定骨向内生长区域和附加装置的人工脊椎盘，以便于植入的人工盘的去除或修正。此外，本发明还包括多种鳍片或导向导轨通道形成机构的实施方式、以及植入具有至少一个鳍片或导向导轨构件的人工盘的诸方法。
虽然阐述和描述了本发明的多种实施方式，但应明白的是，本发明并不仅限于这些实施方式。例如，人工盘***所有或预定部分的骨接触表面可包括骨向内生长表面，而它们并不背离权利要求书中所述本发明的精神和范围。对应本领域技术人员而言，各种改进、改变、变异、替代和等价形式将会是显而易见的。

Claims (25)

1.一种椎间盘间隙制备导向装置，所述装置包括：
形状为可置于椎间盘间隙中并具有第一凹槽的间隔部分；
具有第一通孔的第一加工导向件；
其中，第一通孔对准第一凹槽并适于接受第一骨去除机构。
2.如权利要求1所述的椎间盘间隙制备导向装置，其特征在于，所述第一加工导向件还包括穿透限制伸长件。
3.如权利要求1所述的椎间盘间隙制备导向装置，还包括具有第二通孔的第二加工导向件，其中第一和第二通孔是平行的。
4.一种椎间盘间隙制备导向装置，所述装置包括：
用于***椎间盘间隙的间隔部分；
用于放置在椎间盘间隙外的切割部分，所述切割部分包括第一和第二侧；以及
延伸通过切割部分第一侧的第一导向通孔，
其中，所述第一导向通孔适于接受第一骨去除机构。
5.如权利要求4所述的椎间盘间隙制备导向装置，其特征在于，所述间隔部分包括从第一导向通孔延伸并适于接受第一骨去除机构的第一凹槽。
6.如权利要求5所述的椎间盘间隙制备导向装置，其特征在于，所述第一凹槽的形状为用来在椎骨终板中形成通道，所述通道对应于需***椎间盘间隙中的植入物上的凸起。
7.如权利要求4所述的椎间盘间隙制备导向装置，还包括延伸通过切割导向装置第一侧的第二导向通孔，第二导向通孔平行于第一导向通孔。
8.如权利要求4所述的椎间盘间隙制备导向装置，还包括延伸通过切割导向装置第二侧的第三导向通孔。
9.如权利要求4所述的椎间盘间隙制备导向装置，其特征在于，所述间隔部分的尺寸做成与人工椎间盘的植入物厚度相匹配。
10.如权利要求4所述的椎间盘间隙制备导向装置，其特征在于，所述第一导向通孔还适于接受固定机构。
11.用于制备椎间盘间隙以接受植入物的导向装置，所述导向装置包括：
具有第一凹槽的间隔部分，所述间隔部分适于***椎间盘间隙；
用于将骨去除装置对准第一凹槽的第一加工导向件，所述第一加工导向件包括用来限制导向组件穿透进入椎间盘间隙的第一限制结构。
12.如权利要求11所述的导向装置，其特征在于，所述第一加工导向件还包括对准第一凹槽的第一通孔。
13.如权利要求12所述的导向装置，其特征在于，第一通孔的至少一部分通过第一限制结构。
14.如权利要求11所述的导向装置，还包括适合与推动机构相互作用的啮合结构。
15.如权利要求11所述的导向装置，还包括参考标记。
16.如权利要求11所述的导向装置，其特征在于，所述间隔部分包括平行于第一凹槽的第二凹槽，所述导向装置还包括使骨去除装置对准第二凹槽的第二加工导向件。
17.一种在一对椎骨终板间制备椎间盘间隙以接受植入物的方法，所述方法包括：
选择导向组件，所述导向组件包括间隔部分和导向部分；
将间隔部分***椎间盘间隙，所述间隔部分包括定位于邻近第一块椎骨终板的第一凹槽；
使骨去除器械通过导向部分中的第一通孔并进入间隔部分中的第一凹槽；以及
在邻近第一凹槽的第一椎骨终板中形成第一通道。
18.如权利要求17所述的方法，还包括：
使骨去除器械通过导向部分中的第二通孔并进入间隔部分中的第二凹槽；以及
在邻近第二凹槽的第一椎骨终板中形成第二通道。
19.如权利要求17所述的方法，还包括：
使骨去除器械通过导向部分中的第三通孔并进入间隔部分中的第三凹槽；以及
在邻近第三凹槽的第二椎骨终板中形成第三通道。
20.如权利要求17所述的方法，其特征在于，产生第一通道还包括通过第一通孔从第一椎骨终板除去骨。
21.如权利要求17所述的方法，其特征在于，所述骨去除器械是钻孔器。
22.如权利要求17所述的方法，还包括：
将植入物***椎间盘间隙中以及
对准植入物上的凸起以啮合第一通道。
23.一种制备椎间盘间隙以接受植入物的导向装置，所述导向装置包括：
适合***椎间盘间隙的内部部分，所述内部部分包括第一面和第二面，所述第一面适于啮合第一椎骨终板并具有第一凹槽，所述第二面适于啮合第二相对椎骨终板并具有第二凹槽；
结合于内部部分并适于放置在椎间盘间隙外的外部部分，所述外部部分包括与第一凹槽对准的第一钻孔和与第二凹槽对准的第二钻孔。
24.如权利要求23所述的导向装置，其特征在于：
所述内部部分还包括具有平行于第一凹槽的第三凹槽的第一面和具有平行于第二凹槽的第四凹槽的第二面，以及
所述外部部分还包括与第三凹槽对准的第三钻孔和与第四凹槽对准的第四钻孔。
25.如权利要求24所述的导向装置，还包括：
与外部部分结合并适于使四个钻孔和凹槽各自发生对准偏移的伸长手柄，从而无需移动伸长手柄就可将钻孔器***各个钻孔和从各个钻孔中移去。
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