CN101547656A - 钻进/碾磨导向器和龙骨切削准备系统 - Google Patents

钻进/碾磨导向器和龙骨切削准备系统 Download PDF

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CN101547656A
CN101547656A CNA2007800315480A CN200780031548A CN101547656A CN 101547656 A CN101547656 A CN 101547656A CN A2007800315480 A CNA2007800315480 A CN A2007800315480A CN 200780031548 A CN200780031548 A CN 200780031548A CN 101547656 A CN101547656 A CN 101547656A
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milling guide
rear end
tool system
guide
cutting element
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R·伯特阿格诺利
D·默里
J·P·富阿达
M·里陈
D·杰尔伯
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Synthes USA LLC
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Abstract

工具系统、相关联的碾磨或钻进导向器和方法包括使用尺寸与用于椎骨间空间的实际植入物相符的试验植入物，其中碾磨导向器安装在试验植入物上。碾磨导向器包括从前端到后端逐渐变小的纵向导向器舱室。为了在毗连椎骨中形成切口，该系统还包括收在导向器舱室中的切削工具。这个切削工具包括通过枢轴与后端接合在逐渐变小的导向器舱室中形成切削工具的枢轴的支承构件。不是碾磨导向器能被反转在其它椎骨中形成切口，就是碾磨导向器能备有两个导向器舱室，连同在它们之间移动的一个切削工具或两个各自的切削工具一起使用。

Description

钻进/碾磨导向器和龙骨切削准备系统
技术领域
这项发明涉及椎骨间植入物，更明确地说，涉及在将椎骨间植入物插入椎骨间空间的准备工作中用来切削龙骨狭槽的新的和改进的导向器、系统和方法。
背景技术
现在，当有必要把椎间盘完全地从毗连的椎骨之间移开的时候，传统的程序是使毗连的椎骨融合。最近，在椎间盘替换的领域已有重大发展，即，椎间盘关节成形术，包括将人造的椎间盘植入物插入毗连椎骨之间的椎骨间空间。这允许毗连椎骨彼此相对有限的万向运动。
为了准备用来接受人造椎间盘植入物的椎骨间空间，迄今已经研发了一些工具。这些包括一系列不同尺寸的试验植入物，这些不同尺寸的试验植入物将被插入已被清除的椎骨间空间，直到确定正确尺寸的试验植入物，借此确定准备永久插入的实际椎间盘植入物的尺寸。试验植入物可能有固定的止挡构件，该止挡构件呈固定在试验植入物后端并且垂直地上下延伸的销钉形式以便限制试验植入物进入椎骨间空间的运动。
一些椎间盘植入物有在每终板上升起的龙骨，这需要在毗连椎骨间空间的椎骨上形成切口以便接受这些升起的龙骨。用来形成这些切口的一种已知的安排是采用凿子，该凿子被安装成随着凿子切入毗连的椎骨形成切口能沿着选定的试验植入物的顶端和底部的狭槽移动。
此外，也能使用通过凿、钻进或碾磨加工的狭槽，而且这些程序的组合也是可能的。然而，在使用凿子和木槌进行凿切的场合，将沿着切削方向施加相当大的力。采用钻，将涉及较少的力，但是在钻进期间，钻头可能打滑或弯曲。采用碾磨，能进行精确的切削而且不需要大的力，但是碾磨工具需要有特定的直径，因为否则它在碾磨期间将会破裂并因此在需要狭长切口的情况下碾磨并非总是可能的。因此，用来不需要施加大的力就能完成狭窄的切口的程序是令人想要的。可仿效的这样的现有技术的装置和方法是在通过引证并入的USPA 2004-0215198(Marnay等人)和USPA 2006-0064100(Bertagnoli等人)中揭示的那些。
一种已知的人造椎间盘植入物是在2001年1月11日公开的世界专利申请公开第WO 01/01893号中展示的；而用来将该人造椎间盘植入物插入的工具是在USPA 7,118,580(Beyersdorff，或专利申请公开第WO 01/19295号)和USPA 2004-0215198(Marnay，或专利申请公开第WO 04/098380号)中展示的。这些参考文献也在此通过引证被并入。
虽然这些已知的工具和方法表现出技术上实质性的进步，但是在用来为接受人造椎间盘植入物准备椎骨间空间的工具和方法领域仍然存在继续改进的需求。
发明内容
本发明的目的是提供用来为接受人造椎间盘植入物准备椎骨间空间的改良的新工具和相关的方法。
本发明的工具可以用来沿着脊柱(主要包括腰部脊柱和颈部脊柱)在任何位置准备椎骨间空间。然而，因为颈部椎骨相对于腰部椎骨是如此小，即，大约为腰部脊柱椎骨面积的20％，所以一些工具可能比其它工具更适合于颈部脊柱。
目前，椎骨间植入物通常是从病人的前面插入，向患者的背部移动。然而，人们将理解的是，植入物、工具和方法也能被设计和安排成横向(即，从侧面)插入植入物，在这种情况下龙骨将依照这样的横向运动在植入物上定向而且毗连的椎骨上的切口将向侧面敞开以便接受龙骨。为了避免与患者的解剖学混淆，本发明将在此就与工具和方法本身有关的较简单的用辞进行描述。举例来说，在描述本发明时，术语“前面”或“向前”意味着该工具部分面对椎骨或正沿着向椎骨运动的方向移动，而单词“背面”、“后面”或“向后”指的是工具的末端离椎骨最远或正从椎骨移开。另外，在这份申请中，单词“上面的”或“下面的”或＂降低＂或“最上面的”或“最下面的”或描述椎骨间植入物或工具或与之相关联的方法的取向的任何其它单词仅仅是为了方便才使用的，而且不倾向于告知任何限制。更明确地说，在这份申请中参照上面的部分描述的植入物、工具和/或方法的部分事实上能在患者的椎骨里面作为上好的或次等的部分定位，而两个部分中的另一部分作为相反的部分。
因此，本发明的目的是提供用来为接受人造椎间盘植入物准备椎骨间空间的改良的新工具和方法。
本发明的工具和方法特别适合供有彼此相对经历有限的万向运动的上面部分和下面部分的人造椎间盘植入物使用，其中上面部分和下面部分的上表面和下表面与毗连椎骨的表面接合。本发明的工具和方法大部分也适用于植入物有从植入物的椎骨接合表面伸进在毗连椎骨中形成的切口的龙骨。
依照本发明的第一方面，提供用来与在椎骨上形成切口相结合插入不同尺寸的试验植入物(直到确定正确的试验植入物)的改良的工具和方法。该工具系统包括尺寸与用于该椎骨间空间的实际植入物相符的试验植入物和安装在试验植入物上的碾磨导向器。该碾磨导向器包括一个(或两个并排的)从前端到后端逐渐变小的纵向导向器舱室。该系统还包括收在导向器舱室中用来在毗连的椎骨中形成切口的切削工具。这个切削工具包括支承构件，该支承构件通过枢轴与后端接合在锥形导向器舱室中形成用于切削工具的枢轴。不是碾磨导向器能被反转在另一个椎骨中形成切口；就是碾磨导向器能具有两个导向器舱室，以便供在它们之间移动的一个切削工具使用或分别供两个切削工具使用。
在该工具系统的优选实施方案中，导向器舱室沿着头盖到尾部的方向逐渐变小。除此之外，切削工具有锥形的切削头而且测试头包括毗连可接受切削头的导向器舱室的纵向凹槽。这个纵向凹槽也优选比切削头大以便为切削椎骨提供容器。
另外，在优选实施方案中，试验植入物包括当测试头被适当地放置在椎骨间空间中的时候与毗连的椎骨接合的可调止挡。然后，碾磨导向器包括用来把碾磨导向器在试验主体上可移动地安装到预先设定的位置的安装装置。除此之外，支承构件在切削工具上是可移动地调整的。
在优选的实施方案中，借助支承构件接合的碾磨导向器后端包括这样的支承机制，以致该枢轴在切削期间不移动。在一个实施方案中，该支承机制是通过支承构件接合的一部分后端的弯曲部分。在另一个实施方案中，该支承机制是安装在后端的活动支承；该活动支承能在需要时被可拆卸地安装。在另外一个实施方案中，该支承机制包括向前端延伸的加长管以便在切削期间为切削工具提供附加的支撑。
另外，依照第一方面，提供一种碾磨导向器和使用该碾磨导向器生成切口的方法。采用该碾磨导向器，在该方法中，切削工具的旋转和移动被用来产生切削工具端的挡风玻璃刮水器的刮扫运动以便在毗连的椎骨中形成切口。这种切削通过位于切削工具上的支承构件的纵向移动一直进行到该支承构件通过枢轴与碾磨导向器的后端接合，以便在逐渐变小的导向器舱室中形成切削工具的枢轴。
依照本发明的第二方面，供用来为接受植入物准备椎骨间空间的工具系统使用的碾磨导向器包括用来按预先设定的位置在试验植入物上安装的安装装置和一对纵向导向器舱室。这些导向器舱室从后端共用的入口孔延伸到前端各自的出口孔。因此，钻进工具被收在该入口端中，而且可依照需要从任一出口孔有选择地移出，以便在毗连的椎骨中形成两个钻孔。
本发明的目的是提供新的改良的用来为接受人造椎间盘植入物准备椎骨间空间的工具。
本发明的另一个目的是提供新的改良的用来为接受人造椎间盘植入物准备椎骨间空间的方法。
本发明的这些和其它目的从下面的详细描述和附图将变得明显。
附图说明
图1是毗连两个椎骨体之间的椎骨间空间的椎骨间植入物的透视图。
图2是椎骨体的透视图，现在该椎骨体有在其中提供的龙骨狭槽。
图3是部分地插进两个椎骨体之间的椎骨间空间的椎骨间植入物的透视图。
图4是完全插进两个椎骨体之间的椎骨间空间的椎骨间植入物的透视图。
图5是依照本发明的碾磨系统的正面、侧面和平面透视图。
图6是图5所示碾磨系统连同试验植入物放置在椎骨间空间的背面、侧面和轮廓的透视图。
图7是依照本发明的试验植入物的正面、侧面和平面透视图。
图8是图7所示试验植入物连同附加手柄的正面、侧面和平面透视图。
图9是依照本发明的碾磨导向器的正面、侧面和平面透视图。
图10是图5所示碾磨系统的正面、侧面和平面剖视透视图。
图11是调整可调止挡时插进椎骨间空间的图7所示试验植入物的背面、侧面和平面透视图。
图12是完全放置在椎骨间空间中的图11所示试验植入物的背面、侧面和平面透视图。
图13是图12所示试验植入物安装图9所示碾磨导向器时的背面、侧面和平面透视图。
图14是图12所示试验植入物安装图9所示碾磨导向器后的背面、侧面和平面透视图。
图15是展示钻孔器最初插进安装在图12所示试验植入物上的图9所示碾磨导向器的背面、侧面和平面透视图。
图16是展示使用在安装在试验植入物上的碾磨导向器中的钻孔器开始切削的背面、侧面和平面透视图。
图17是展示当钻孔器上的止挡与安装在试验植入物上的碾磨导向器接合时使用钻孔器完成切削的背面、侧面和平面透视图。
图18-20是展示钻孔器在碾磨导向器中的切削动作的正面、侧面和平面剖视透视图。
图21是展示使用图18-20描绘的切削动作钻孔器所进行的龙骨切削的正面、侧面和平面局部放大剖视透视图。
图22是碾磨导向器的近端有支承的替代设计的背面、侧面和平面透视图。
图23是试验植入物有通孔的替代设计的平面图。
图24是一次性枢轴元素的替代设计的背面、侧面和平面透视图。
图25是图24描绘的一次性枢轴元素的正面、侧面和平面透视图。
图26是有加长管的另一种带枢轴元素的碾磨系统的背面、侧面和平面透视图。
图27是用于钻进的替代碾磨导向器的正面、侧面和平面透视图。
图28是图27描绘的替代碾磨导向器的改进实施方案的正面、侧面和平面透视图。
图29是附着在图5所示碾磨系统上的手柄的背面、侧面和平面透视图。
图30是使用盒形凿子的替代碾磨导向器的正面、侧面和平面透视图。
图31是安装在钻孔器部分上的可调套筒的侧视图。
图32是连同定距垫圈一起安装在钻孔器部分上的一个套筒的侧视图。
图33是替代图25所示的枢轴元素的较高的枢轴元素的背面、侧面和平面透视图。
图34是替代图9所示的碾磨导向器的在上面部分有两个碾磨室的碾磨导向器的正面、侧面和平面透视图。
具体实施方式
在此描述的工具和方法可适用于准备适合插入椎骨间空间的各种人造椎间盘植入物，典型地适用于TDR(整个椎间盘替换)。对于那些在此描述的工具和方法(包括形成接受升起的龙骨的切口的概念)，在此描述的工具和方法适合供有这样的龙骨的任何人造椎间盘植入物使用。因此，关于所引用的植入物的描绘和描述是可仿效的。
现在参照附图，其中相似的数字在各种不同的视图中表示相似的元素，人们最初将领会到本发明指向改善椎骨间植入物10的原始稳定性，例如，USP 7,204,852(Marnay等人)所揭示的，该椎骨间植入物位于毗连椎骨体12之间(对于融合或非融合程序)，如图1-4所示。植入物10被设计成在接触毗连椎骨主体12的两个终板16上有龙骨14，如图1所示。为了把植入物10放进椎间盘切除术之后提供的椎间盘空间，需要在上下椎骨体12中进行切削以提供图2清楚地展示的狭槽18。植入物10在图3中被展示成部分地在椎骨主体12之间，而在图4中被展示为完全插入。
适合TDR的大多数外科技术使用凿子完成或准备龙骨切口或狭槽18。然而，依照本发明，为了减少冲击力和为了改善龙骨切口后表面的清洁处理，已研发了钻进/碾磨系统20作为替代品，以防万一有坚硬的骨头和/或硬化的终板。碾磨系统20包括下列在图5-6中充分展示的彼此相互作用的主要工具：有可调止挡24的试验植入物22、用于试验植入物22的可分离的手柄26(只在图8展示)、碾磨导向器28和钻孔器30(连同现有的/已知的电动工具设备一起使用)。
试验植入物22是在图7中更详细地展示的。它实现已知的确定待用植入物10的正确高度的功能，举例来说，在植入物10有不同高度的情况下，将有不同的试验植入物22适应每种高度(例如，5毫米、6毫米和7毫米)。因此，选定的有整块的植入物头部32的试验植入物22在可分离的手柄26的帮助下插在椎骨体12之间看看该选定的测试头32是否适当地吻合，以便知道正确的植入物高度(和尺寸，如果需要)。很明显，有对应的头部32的试验植入物22的各种不同的高度可用于这样的试验和误差确定；而且如果需要，植入物的不同尺寸的覆盖区和/或形状等等也能尝试是否需要确定最好的待用植入物10。依照本发明，一旦正确尺寸的试验植入物22被插入，该试验植入物22的主体34就充当待连接或待安装的碾磨导向器28的基础。
如图8所示，为了方便，可分离的手柄26可拆卸地附着到(例如，通过球/棘爪相互作用)可调止挡24的螺纹轴36上。人们将领会到可调止挡24在图7中也被清楚地展示而且是通过螺纹轴36可移动地安装在试验植入物22的主体34的后面。可调止挡24包括上面的和下面的椎骨接合构件38，因此它的纵向位置相对于测试头32是可调的。接合构件38附着在到轴36上并且如图所示为试验主体34的运动导向，而且接合构件38相对于试验植入物22的中线是对称放置的以改善对A/P力的抗拒。除此之外，接合构件38的分离设计允许钻孔器30在两个接合构件38之间移动，接合构件38提供对软组织的额外保护使之免受钻孔器30损伤。作为替代，试验植入物22可能只包括一边止挡构件或两个止挡构件放在上面的和下面的椎骨主体12的任一边。试验植入物22在头盖一侧(上面)和尾部一侧(下面)包括在测试头32中的中央凹槽40，钻孔器30能进入或插入该中央凹槽。作为替代，试验主体32可能包括有相同功能的穿过整个(分离/分叉的)试验主体的洞。
碾磨导向器28是在图9中最清楚地展示的。碾磨导向器28被设计成与试验植入物22的试验主体34连接。当碾磨导向器28沿着轴36在试验植入物22的后部为运动导向，另外如同在图7中清楚地看到的那样借助沿着试验植入物22的大部分长度移动的导向器特征42导向的时候，这种连接发生。这个导向特征42是沿着试验主体34的任一边(上面的和下面的)凸出的短边缘44和在碾磨导向器28的配合表面提供的有对应的间隔和形状的凹槽46的组合。碾磨导向器28被放置在试验的主体34上，直到止挡表面48与试验主体34的后端配对，这造成碾磨导向器28的近端和试验植入物22的远端之间的固定距离。优选的是，使用锁定机制50防止碾磨导向器28与试验植入物22意外地脱开和/或消除碾磨导向器28和试验植入物22之间的任何空隙/运动。锁定机制50被展示为配合楔52，但是可能使用片簧、锁定螺钉或技术上已知的其它机制。碾磨导向器28还包括在一边的手柄附着构件53，手柄(例如图29中的手柄106)可拆卸地附着在该附着构件上，例如，借助螺纹连接。
如图10所示，碾磨导向器28定义为各自的钻孔器30导向的上面的和下面的舱室54。每个舱室54都如同图18-20清楚地展示的那样从前到后逐渐变小，以便考虑到围绕着位于碾磨导向器后端的枢轴56的挡风玻璃刮水器碾磨周期60(见图19的箭头，并且与图18-20中的钻孔器30的位置进行比较)。在图示的实施方案中，钻孔器30受横向限制，而且被允许仅仅沿着头盖-尾部的方向碾磨。然而，在替代实施方案中，舱室54可以考虑到沿着至少一个其它方向碾磨直到沿着所有的方向碾磨。碾磨动作和技术将在下文中更详细地描述。此外，舱室54也可能自然地呈较多的圆筒形以便考虑到沿着头盖-尾部的方向较多平移的碾磨周期。
作为已揭示的实施方案的替代品，人们将领会到碾磨导向器28可以改为只包括一个钻孔器导向舱室54，该舱室将位于试验植入物22的一边(上边或下边)。于是，在完成第一龙骨切口之后，钻孔器30将缩回，然后在碾磨第二(另一边的)龙骨切口之前，该碾磨导向器翻转180°并且被再次插入。钻孔器也可能被预先装配到这样的碾磨导向器上，以容易地允许这个碾磨导向器在为另一个龙骨切口翻转和再次插入之前缩回特定的距离。作为另一个替代选择，碾磨导向器和试验植入物可能被设计成有上述功能的一个工具。
如果需要，不同的钻孔器30可能连同系统20一起使用，主要取决于是否需要钻进和/或碾磨(单边切削)能力。因此，可仿效的钻孔器将包括，举例来说，普通钻孔机、(林德曼)Lindemann钻孔器和颅骨钻器；而且技术上已知的和使用的其它钻孔器也能在需要时使用。钻孔器30的切削端优选呈锥形形状，从远端(前端)较小的直径慢慢地向较大的轴径扩张。锥形形状的好处是较小的尖端补偿在碾磨导向器28的舱室54内钻孔器的小动作。但是，作为替代，钻孔器顶端依照需要可能是圆筒形的，逐渐变小的或圆筒形、逐渐变小和/或锥形的组合。每个钻孔器30也包括整合套筒58，该套筒抵住碾磨导向器30的后端以便与前面提到的可调止挡24的使用结合控制钻孔器28刺入椎骨主体12的深度。当套筒58抵住后端的时候，它起支承构件的作用抵住后端，下面将更全面地描述。
在使用中，以下列方式使用钻进/碾磨系统20，参照图11-17。最初，在完成椎间盘切除术(图1)之后，外科医生使用试验植入物确定每个特定的椎骨空间所需要的植入物10的正确高度(和覆盖区域尺寸，如果需要的话)。更重要的是，与每个植入物一样，最后的或正确的试验植入物是与整合的可调止挡24一起插入的(图11)，可调止挡24不仅把试验植入物22相对于椎骨主体12固定在它的正确位置而且保证试验植入物22不进一步向后滑进椎管(图12)。一旦找到正确的尺寸和正确的位置，就通过使用导向特征42使碾磨导向器28在试验主体34上滑动(图13)和用锁定机制50把碾磨导向器28锁定到试验主体34上(图14)将碾磨导向器28安装到试验主体34上。
接下来，外科医生在他选择的椎骨主体12上完成第一切口。使用有侧面切削能力的钻孔器或钻孔机，外科医生首先直立地向椎骨主体12内钻进/切削，直到钻孔器30上的套筒58被碾磨导向器28顶住，如图15-17所示。然后，外科医生沿着终板的方向清理完成龙骨切口，如图18-20所示。外科医生也可能通过沿着终板钻进/切削开始该切割，然后在需要时进入椎骨主体之内清理；或钻两块椎骨的中间物并且向上下两边清理。放在钻孔器30上的套筒58避免对椎骨主体12的钻进/切削太深，同时充当支承构件抵住碾磨导向器30的后端。图21描绘的是用系统20制作的龙骨切口或狭槽18的放大图。
最后，外科医生移开钻孔器30并且在其它椎骨主体12上重复相同的操作。图2展示用系统20在相应的椎骨主体12上制作的龙骨切口18。该切削工具便于用任何已知的电动工具(例如，E-pen、MidasRex、Stryker TPS)供电。首先使用的钻孔器30也可能在完成该切口或第一钻孔之后使用第二钻孔器在对面碾磨该龙骨切口的时候被适当地留下以稳定该构造，如描绘两个钻孔器30的图10所示。如果骨头极硬，钻孔器30也可能是在用清理碾磨步骤完成龙骨切口之前为使骨头变弱先钻几次之时使用的。为了考虑到不同的钻进/碾磨深度，作为替代，在钻孔器30上充当的止挡的套筒58可能是可分离的或可调的，如图31的套筒58′所示，该套筒通过松开简单的固定螺钉59变成可调的。
人们将注意到碾磨导向器28提供逐渐变小的碾磨室54，该碾磨室允许钻孔器在导向器的近端绕枢轴转动，如图18-20所示。因为这个理由，碾磨导向器28的近端(在后端)64向头盖端和尾端略微弯曲。这允许钻孔器30在转向测试体32的时候下降得更深一点，从而导致在龙骨切口18的后端是较直的壁而不是从这样的摆动期待的弧。作为替代，如果这样的弧形末端并非要不得，碾磨导向器28的近端也可能是直的。人们还将领会到系统20的纤细和形状也考虑到外科医生有好的能见度。
图22描绘的是碾磨导向器28的近端66的替代设计，其中在每个碾磨室54的近端66提供其中带滑动轴承70的枢轴元素68。为了将碾磨导向器28和钻孔器30之间的摩擦减到最小，滑动轴承70接受钻孔器30的轴。滑动轴承70便于在小销钉(未展示)周围旋转的枢轴元素72支撑，这允许钻孔器30的受控的清理动作。
图23描绘的是植入物测试头76有通孔78的替代实施方案。通孔78为钻孔器30留出必要的空间，而且不会危及测试头76的强度，因为测试头76的前端部分是封闭的，如图所示。通孔78是为改善铰除程序期间所产生的骨屑材料在测试头76中的滞留提供的。
图24-25描绘的是与上述枢轴元素68类似的一次性替代枢轴元素80。如果其中滑动轴承(未展示)的寿命被认为太短或不需要重复使用，那么支撑滑动轴承的枢轴元素80变成一次性的。每次外科手术之后将更换碾磨导向器中的滑动轴承和枢轴元素80。供这种类型的枢轴元素使用的材料可能是PEEK。在依轴转动元素80上提供的一对卡扣式或弹簧式接收脚82允许枢轴元素80在碾磨导向器的后端附着到销钉84(见图22)上和从该销钉上拆除。
作为替代，枢轴元素80可能是按不同的高度制作的，例如，用图33中的枢轴元素80′展示的，由于头部86的高度该枢轴元素比枢轴元素80高(然而，作为替代，头部86以下的部分可能改为被增高)。采用不同高度的枢轴元素，外科医生将选择所需的高度，以便依照需要相对于套筒58接触枢轴元素的位置确定钻孔器30的切削端的位置。这样的枢轴元素80′可能被设计成一次性的，也可能不这样设计。
图26描绘的是碾磨系统20′的另一个替代实施方案，有包括为给钻孔器30提供导向而设计的加长管90的枢轴元素88。如果需要或想要，加长管90从安装销钉92处的支承/枢轴部分延伸到碾磨导向器的远端(前端)为钻孔器30提供增强的支撑。作为另一种替代选择，可能在需要时把一个或多个定距薄垫圈62a和/或62b加到套筒58下面，如图32所示。垫圈62用来进一步把套筒58与枢轴元素88(或在上述的其它实施方案中与碾磨导向器28)略微隔开，并因此将变成钻孔器30抵住碾磨导向器28后端的支承构件部分。图示的垫圈62a和62b有不同的高度，而且在需要时可能每种垫圈使用一个或多个，或使用不同高度的其它垫圈。这样的垫圈将优选沿着钻孔器30有摩擦地滑动，以致垫圈62在不主动移动它的情况下不沿着钻孔器30移动，并因此不会偶然地从钻孔器30上跌落。
图27描绘的是用于直孔钻进或切削的碾磨导向器96的替代实施方案。碾磨导向器96是在需要减少在典型的现有技术中用来形成龙骨切口的后续凿切步骤产生的冲击力的时候作为选项提供的。龙骨切削技术将包括在使用楔形和/或盒形凿子(未展示)之前使用钻孔机98为每个龙骨钻一个或两个平行的直孔以除去骨头。为此目的，碾磨导向器96包括用于每个龙骨切口位置的两个导向孔100a和100b。所示的系统也有替代可调止挡设计，该设计有相对于插入轴或纵轴对称放置的两个侧面止挡102。为了从椎骨终板除去较多的骨头，碾磨导向器96上的孔102b可能如图28所示用碾磨导向器96′向试验主体转某个角度。如果钻孔器30有逐渐变小的/锥形的尖，用逐渐变小的/锥形的尖产生的钻孔将被设计成与试验表面平行，或至少考虑到在试验主体的近端(前端)除去较多的骨头。在该图中，外科医生将在每边钻两个孔，但是每边的两个孔是不平行的。
如果需要，任何碾磨(或钻进)导向器都是借助图29所示的(和部分地用图22展示的)导向器手柄106稳定或控制的。作为替代，导向器手柄106也可能附着到固定器或牵引器系统上(例如，Synthes的
Figure A200780031548D00241
如果外科医生感到用凿切完成龙骨切口舒服，试验植入物22也能使盒形凿子112适应导向器110，如图30所示。导向器110同样地被安装到碾磨导向器28上，允许外科医生在需要时使用钻孔或凿切方法完成龙骨切口。
虽然上述的实施方案已经描绘了在毗连的椎骨主体12上形成上面的和下面的龙骨狭槽的情况，但是可能存在植入物在一侧(或两侧)有并排的或成双的(或多个)龙骨的情况，所以需要在椎骨主体12上切削两个龙骨狭槽。在这种情况，提供图34所示的碾磨导向器28′将是可能的。碾磨导向器28′在顶部有两个并排的碾磨室54′，有对应的后端(未展示)用来适应每个碾磨室54′的钻孔器30。因此，也将提供用一对试验凹槽适应两个碾磨室舱室的试验植入物(未展示)。
虽然上述的零部件优选用金属(例如，不锈钢、钛或钛合金)制成，但是作为替代一些零部件可能用复合材料或聚合物制成。除此之外，这种类型的骨头切削程序不局限于颈椎，可能被用于人体的任何部位，具体地说，它可能适用于腰部的TDR。
虽然本发明已经就其优选实施方案被相当详细地描述，但是本发明可以有许多修正和变化将是明显的，对于熟悉这项技术的人将是明显的。

Claims (44)

1.一种用来为接受植入物而准备椎骨间空间的工具系统，其中包括：
尺寸与用于椎骨间空间的实际植入物相符的试验植入物；
安装在所述试验植入物上的碾磨导向器，所述碾磨导向器包括从前端到后端逐渐变小的纵向导向器舱室；以及
切削工具，该切削工具被接受在所述的导向器舱室中，以便在毗连椎骨中形成切口，所述的切削工具包括与所述后端接合并与之在所述的锥形导向器舱室中为所述的切削工具形成枢轴的支承构件。
2.根据权利要求1的工具系统，其中所述的导向器舱室是沿着从头盖到尾部的方向逐渐变小的。
3.根据权利要求2的工具系统，其中所述的切削工具有锥形的切削头。
4.根据权利要求3的工具系统，其中所述的试验植入物包括位于椎骨间空间中的测试头，所述的测试头包括毗连可接受所述切削头的所述导向器舱室的纵向凹槽。
5.根据权利要求4的工具系统，其中所述纵向凹槽大于所述切头以便为切削椎骨提供容器。
6.根据权利要求1的工具系统，
其中所述试验植入物包括测试头、远离所述的测试头延伸的细长试验体和当所述试验头被适当地放置在椎骨间空间中的时候与毗连椎骨接合的可调止挡；
其中所述碾磨导向器包括用来在所述的试验主体上把所述的碾磨导向器可移动地安装到预先设定的位置的安装装置；而且
其中所述的支承构件可以在所述的切削工具上移动地调整。
7.根据权利要求1的工具系统，其中借助所述支承构件接合的所述碾磨导向器的后端包括支承机制，以致所述枢轴在切削期间不移动。
8.根据权利要求7的工具系统，其中所述支承机制是借助所述支承构件接合的所述碾磨导向器的一部分所述后端的弯曲部分。
9.根据权利要求7的工具系统，其中所述支承机制是安装在所述碾磨导向器的所述后端的活动支承。
10.根据权利要求9的工具系统，其中所述活动支承被可拆装地安装在所述的后端中。
11.根据权利要求7的工具系统，其中所述支承机制包括向所述的前端延伸以便为所述的切削工具提供附加支撑的加长管。
12.根据权利要求1的工具系统，其中所述碾磨导向器包括两个并排的纵向导向器舱室，以便在毗连的椎骨中形成两个并排的切口。
13.一种供用来准备接受植入物的椎骨间空间的工具系统使用的碾磨导向器，该工具系统包括尺寸与用于该椎骨间空间的实际植入物相符的试验植入物，所述碾磨导向器包括：
用来在试验植入物上按预先设定的位置安装的安装装置；以及
纵向导向器舱室，该纵向导向器舱室从前端到后端逐渐变小以致接受在所述导向器舱室中用来在毗连的椎骨中形成切口的切削工具使所述的后端与支承构件接合，从而在所述的锥形导向器舱室中与之形成用于切削工具的枢轴。
14.根据权利要求13的碾磨导向器，其中所述的导向器舱室安装在所述试验植入物上的时候是沿着从头盖到尾部的方向逐渐变小的。
15.根据权利要求13的碾磨导向器，其中借助支承构件接合的后端包括支承机制，以致所述的枢轴在切削期间不移动。
16.根据权利要求15的碾磨导向器，其中所述的支承机制是借助支承构件接合的一部分所述后端的弯曲部分。
17.根据权利要求15的碾磨导向器，其中所述支承机制是安装在所述后端上的活动支承。
18.根据权利要求17的碾磨导向器，其中所述的活动支承被可拆卸地安装在所述的后端中。
19.根据权利要求15的碾磨导向器，其中所述的支承机制包括朝向所述向前端延伸为切削工具提供补充支撑的加长管。
20.根据权利要求13的碾磨导向器，其中并排有两个所述纵向导向器舱室，以便在毗连的椎骨中形成两个并排的切口。
21.一种用来准备接受植入物的椎骨间空间的工具系统，其中包括：
尺寸与用于椎骨间空间的实际植入物相符的试验植入物；
安装在所述试验植入物上的碾磨导向器，所述碾磨导向器包括从前端到后端逐渐变小的上下纵向导向器舱室；以及
被接受在所述的导向器舱室中用来分别在上面的和下面的毗连椎骨中形成切口的切削工具，所述的切削工具包括与所述的后端接合并在所述的锥形导向器舱室中与之形成适合所述切削工具的枢轴的支承构件。
22.根据权利要求21的工具系统，其中所述的导向器舱室沿着从头盖到尾部的方向逐渐变小。
23.根据权利要求22的工具系统，其中所述的切削工具有锥形的切削头。
24.根据权利要求23的工具系统，其中所述试验植入物包括位于椎骨间空间中的测试头，所述的测试头包括毗连各自的可接受所述切削头的所述的上下导向器舱室的上下纵向凹槽。
25.根据权利要求24的工具系统，其中所述的纵向凹槽形成一个比所述切削头宽的通孔以便为切削椎骨提供容器。
26.根据权利要求21的工具系统，
其中所述的试验植入物包括测试头、远离所述的测试头延伸的加长的试验主体和当所述的测试头被适当地放置在椎骨间空间中的时候与毗连的上下椎骨接合的可调止挡；
其中所述的碾磨导向器包括用来在所述的试验主体上把所述的碾磨导向器可移动地安装到预先设定的锁定位置的安装装置；以及
其中所述的支承构件在所述的切削工具上是可移动调整的。
27.根据权利要求21的工具系统，其中所述碾磨导向器的上下后端每个都包括这样的支承机制，以致所述的枢轴在切削期间不移动。
28.根据权利要求27的工具系统，其中所述的支承机制每个都是借助所述支承构件接合的所述碾磨导向器的一部分所述后端的弯曲部分。
29.根据权利要求27的工具系统，其中所述支承机制每个都是安装在所述碾磨导向器的所述后端中的活动支承。
30.根据权利要求29的工具系统，其中所述的活动支承每个都被可移动地安装在所述后端中。
31.根据权利要求27的工具系统，其中所述支承机制每个都包括向所述前端延伸的加长管，以便为了提供适合所述切削工具的补充支撑。
32.根据权利要求21的工具系统，其中所述的碾磨导向器包括两个并排的上或下纵向导向器舱室以便在毗连的椎骨中形成两并排的切口。
33.一种供用来准备接受植入物的椎骨间空间的工具系统使用的碾磨导向器，该工具系统包括尺寸与用于该椎骨间空间的实际植入物相符的试验植入物，所述的碾磨导向器包括：
用来按预先设定的位置安装在试验植入物上的安装装置；以及
一对纵向导向器舱室，这对纵向导向器舱室从共同的后端入口孔延伸到在前端的各自的出口孔，以致收在所述的入口端的钻进工具能在需要时有选择地从任一出口孔移出并且在毗连的椎骨中形成两个钻孔。
34.一种用来准备接受植入物的椎骨间空间的方法，该方法包括下列步骤：
把尺寸与实际植入物相符的试验植入物放进椎骨间空间；
把碾磨导向器安装在所述的试验植入物上，所述的碾磨导向器包括从前端到后端逐渐变小的纵向导向器舱室；以及
把切削工具插入所述的导向器舱室；以及
在挡风玻璃刮水器的刮扫运动中使所述的切削工具旋转并且移动所述的切削工具，以便在毗连的椎骨中形成切口，所述的旋转和移动步骤包括位于所述的切削工具之上的支承构件的纵向移动，直到所述的支承构件与所述的后端接合并且在所述的锥形导向器舱室中与之形成用于所述的切削工具的枢轴。
35.根据权利要求34的准备方法，其中所述导向器舱室是沿着头盖到尾部的方向逐渐变小的，以致所述的移动步骤是沿着头盖到尾部的方向进行的。
36.根据权利要求35的准备方法，其中所述切削工具有锥形的切削头。
37.根据权利要求36的准备方法，其中所述的试验植入物包括位于椎骨间空间的测试头，所述的测试头包括毗连所述的在所述的旋转和移动步骤期间可接受所述的切削头的导向器舱室的纵向凹槽。
38.根据权利要求37的准备方法，其中所述的纵向凹槽比所述的切削头大以便为切削椎骨提供容器。
39.根据权利要求34的准备方法，进一步包括在所述的切削工具上可移动地调整所述支承构件的步骤。
40.根据权利要求34的准备方法，其中借助所述的支承构件接合的后端包括这样的支承机制，以致所述的枢轴在所述的旋转和移动步骤期间不移动。
41.根据权利要求40的准备方法，其中所述的支承机制是借助所述的支承构件接合的一部分所述后端的弯曲部分。
42.根据权利要求40的准备方法，其中所述的支承机制是安装在所述后端中的活动支承。
43.根据权利要求42的准备方法，其中所述支承被可拆卸地安装在所述的后端中。
44.根据权利要求40的准备方法，其中所述的支承机制包括向所述的前端延伸的加长管以便在所述的旋转和移动步骤期间为所述的切削工具提供补充支撑。
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