CN107072672A - 胫骨结节截骨术引导件 - Google Patents

胫骨结节截骨术引导件 Download PDF

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CN107072672A
CN107072672A CN201580060122.2A CN201580060122A CN107072672A CN 107072672 A CN107072672 A CN 107072672A CN 201580060122 A CN201580060122 A CN 201580060122A CN 107072672 A CN107072672 A CN 107072672A
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W·马克森
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Biomet Sports Medicine LLC
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Abstract

提供了用于胫骨结节截骨术的患者特定的引导件。该引导件包括引导件本体(102、302)，该引导件本体限定：具有骨骼接合表面(103、303)的一部分，该骨骼接合表面作为负表面与特定患者的胫骨的对应表面保持一致；以及引导部分，该引导部分将手术器械引导到特定患者的胫骨上的特定位置，其中，在术前计划阶段期间构造该骨骼接合表面和该引导部分。该引导部分可通过插入在多个孔隙(110、116、120)中或平面沟槽(304、314、315)中的销(124)形成。孔隙或槽沟定位在三条直线(112、118、122；或306、316、317)中，以便为在胫骨中切出平面提供锯引导件。也提供了一种待被定位在所形成的空隙(136)中的可植入楔形件(200a、200b)以及用于利用患者特定的引导件实施胫骨结节截骨术的方法。

Description

胫骨结节截骨术引导件
优先权的要求
本申请要求于2014年9月29日提交的美国专利申请No.14/500,019的权益，由此要求该专利申请的优先权，并且将该专利申请通过引用全部结合于此。
背景技术
本章节提供了并不必然是现有技术的与本公开内容有关的背景信息。
胫骨结节截骨术是一种被执行以治疗髌股状况的外科手术，该髌股状况例如为髌骨不稳定性、髌骨疼痛和软骨形成以及骨关节炎。当诸如物理治疗之类的非手术措施已经失效时，通常实施这种截骨术。在胫骨结节截骨术期间，在患者腿部的恰好位于髌骨下方的前部中制造切口，并且部分地切除胫骨的近侧前部以产生结节皮瓣。随后将该结节皮瓣沿前部和内侧-外侧方向复位(reposition)并用螺钉将其保持在适当位置中。通常，胫骨结节截骨术导致结节的前内侧移位(AMZ)。该复位改变了髌骨在患者体内的位置以移除导致疼痛的载荷，从而导致缓解了以髌骨相对于无症状个体的错乱排列为特征的髌股状况。
许多胫骨结节截骨术都在可在市场上买到的截骨术系统的帮助下实施。然而，这些系统通常包括使用复杂的多个单元。此外，可在市场上买到的系统被大量生产，并且并不适合于特定患者的解剖结构。因此，仍需要研发与当前可获得的系统相比是更易于使用的并且被定制生产以匹配特定患者的解剖结构的新型引导系统。
发明内容
本章节提供了对于本公开内容的总体概述，且并不是对其全部范围或其所有特征的详尽公开。
本教导提供了一种用于胫骨截骨术的患者特定的引导件。该引导件包括引导件本体，该引导件本体限定：具有骨骼接合表面的一部分，该骨骼接合表面作为负表面与特定患者的胫骨的对应表面保持一致；以及引导部分，该引导部分将手术器械引导到特定患者的胫骨上的特定位置，其中，在术前计划阶段期间构造该骨骼接合表面和该引导部分。
本教导还提供了一种用于胫骨截骨术的患者特定的引导件，该引导件包括引导件本体，该引导件本体限定：具有骨骼接合表面的一部分，该骨骼接合表面在胫骨截骨术的术前计划阶段期间被构造成作为负表面与特定患者的胫骨的对应表面保持一致；以及被定位在直线上的多个孔隙，该直线相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线限定预定角度。这多个孔隙被构造成对多个销到该胫骨中的插入进行引导。这多个孔隙具有比销的直径大的直径，这在将销保留在胫骨中的同时允许移除该引导件。销被用作用于切除特定患者的胫骨的锯引导件。
本教导进一步提供了一种用于胫骨截骨术的患者特定的引导件，该引导件包括引导件本体，该引导件本体限定：(a)具有骨骼接合表面的一部分，其中，该骨骼接合表面在胫骨截骨术的术前计划阶段期间被构造成作为负表面与特定患者的胫骨的对应表面保持一致；(b)第一平面槽沟，该第一平面槽沟被相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线以第一预定角度定向于第一预定位置；(c)第二平面槽沟，该第二平面槽沟被相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线以第二预定角度定向于第二预定位置；以及(d)多个孔隙。这多个孔隙被构造成接受用于将该引导件可移除地锚固到该特定患者的胫骨的销。
此外，本教导提供了一种用于在患者的胫骨上实施胫骨结节截骨术的方法。该方法包括将患者特定的引导件定位在患者的胫骨上，其中，该引导件包括引导件本体，该引导件本体限定：具有骨骼接合表面的一部分，该骨骼接合表面在胫骨截骨术的术前计划阶段期间被构造成作为负表面与特定患者的胫骨的对应表面保持一致；以及多个孔隙；将这多个销穿过孔隙插入到患者的胫骨中；移除该引导件；以及通过将插入到该胫骨中的销用作锯引导件并在销与销之间邻近于这些销锯切该胫骨，来切除胫骨，以便邻近于胫骨的切除表面产生结节皮瓣。该方法还包括使该结节皮瓣在前部方向中或在前部方向和内侧-外侧方向中复位，以便在该结节皮瓣和该胫骨的切除表面之间形成空隙；以及在该空隙中植入楔形件，其中，该楔形件具有在术前计划阶段期间构造的预定形状，并且其中，该楔形件由促进骨骼向内生长的材料构成。
此外，本教导提供了一种用于在患者的胫骨上实施胫骨结节截骨术的方法。该方法包括将患者特定的引导件定位在患者的胫骨上，其中，该引导件包括：(i)具有骨骼接合表面的一部分，其中，该骨骼接合表面在胫骨截骨术的术前计划阶段期间被构造成作为负表面与特定患者的胫骨的对应表面保持一致；(ii)第一平面槽沟，该第一平面槽沟被相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线以第一预定角度定向于第一预定位置，其中，由该引导件本体限定的第一平面槽沟具有远端和近端，并且其中，该引导件本体进一步限定与该第一远端连通的圆形槽沟；(iii)第二平面槽沟，该第二平面槽沟被相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线以第二预定角度定向于第二预定位置；以及(iv)多个孔隙。该方法还包括通过将销插入穿过该孔隙，而将该引导件锚固到患者的胫骨；将钻头插入穿过该圆形槽沟并穿过该胫骨钻孔；将锯插入穿过该第一槽沟并从该孔到该近端切除第一切口；将锯插入穿过该第二槽沟并切除第二切口；移除销和该引导件；并进一步切除该胫骨以将该第一切口和该第二切口相连，以及可将该第二切口联接到胫骨的表面，从而形成邻近于胫骨的切除表面的结节皮瓣。
本教导另外提供了一种手术套件，该手术套件包括：患者特定的引导件，该引导件具有引导件本体，该引导件本体限定：具有骨骼接合表面的一部分，该骨骼接合表面作为负表面与特定患者的胫骨的对应表面保持一致；以及引导部分，该引导部分将手术器械引导到特定患者的胫骨上的特定位置，其中，在术前计划阶段期间构造该骨骼接合表面和该引导部分；具有预定形状的患者特定的可植入楔形件，其中，在术前计划阶段期间构造该楔形件；以及多个销。
其它适用领域通过本文中所提供的描述而变得明白。在本发明内容中的描述和具体示例仅出于图示说明的目的，且并非旨在限制本公开内容的范围。
附图说明
在对本发明的示例性实施例做出的下列详细描述中，参考附图和在其中可实施本发明的具体实施例进行说明，其中，附图形成了该详细描述的一部分并且仅作为实例示出。将会明白的是，可利用其它实施例并且可进行结构变化，而并不背离本发明的范围。
图1是相对于胫骨定位的第一患者特定的引导件的示意性图示说明；
图2是相对于胫骨定位的第一患者特定的引导件的第二实施例的示意性图示说明；
图3是相对于胫骨定位的第一患者特定的引导件的示意性图示说明，其中，该胫骨中插入有销；
图4是贯穿胫骨沿使用用以产生结节皮瓣的第一患者特定的引导件定位的销剖切的平面的示意性图示说明；
图5是使用第一患者特定的引导件产生的复位后的结节皮瓣的示意性图示说明；
图6A是第一患者特定的植入物的示意性图示说明；
图6B是第二患者特定的植入物的示意性图示说明；
图7是使用第一患者特定的引导件插入到在胫骨中产生的空隙中的患者特定的植入物的示意性图示说明；
图8是相对于胫骨定位的第二患者特定的引导件的示意性图示说明；
图9是贯穿胫骨使用用以产生结节皮瓣的第二患者特定的引导件剖切的平面的示意性图示说明；
图10是使用第二患者特定的引导件产生的复位后的结节皮瓣的示意性图示说明；以及
图11是使用第二患者特定的引导件插入到在胫骨中产生的空隙中的患者特定的植入物的示意性图示说明。
贯穿附图的若干视图，对应的附图标记表示对应的部件。
具体实施方式
现在将参照附图更为充分地描述示例性实施例。
本教导主要提供了患者特定的胫骨结节截骨术引导件，该引导件包括：引导件本体，该引导件本体限定具有骨骼接合表面的部分，该骨骼接合表面作为负表面与特定患者的胫骨的位于患者的胫骨结节周围的对应表面保持一致；以及引导部分，该引导部分将手术器械引导到位于特定患者的胫骨上的特定位置，其中，在术前计划阶段期间，构造该骨骼接合表面和引导部分，在该术前计划阶段期间，医疗专家确定胫骨结节截骨术的位置以及所需的校正量。在不同实施例中，引导件本体进一步限定软组织接合表面，其中，该软组织接合表面在胫骨截骨术的术前计划阶段期间被构造成作为负表面与特定患者的软组织的对应表面保持一致。该软组织可以是患者的内侧副韧带、外侧交叉韧带或髌骨肌腱。在其它实施例中，该引导件本体限定允许清除软组织的表面。
在一个实施例中，该引导部分包括由引导件本体限定的多个孔隙。这多个孔隙被构造成将引导销特定患者的胫骨，其中销被用作用于切除特定患者的胫骨的锯引导件。这多个孔隙被呈三条直线定位，这三条直线相对于在胫骨截骨术的术前计划阶段期间选择的患者胫骨的近侧-远侧轴线限定三个预定角度。
在另一实施例中，该引导部分包括：由引导本体限定的第一平面槽沟(slot)，该第一平面槽沟被相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线而被以第一预定角度定向于第一预定位置；以及由引导件本体限定的第二平面槽沟，该第二平面槽沟被相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线以第二预定角度定位于第二预定位置。由该引导件本体限定的第一平面槽沟具有远端和近端，其中，该引导件本体进一步限定与第一远端连通的圆形槽沟。
该患者特定的对准引导件也可与利用计算机辅助图像方法制备的传统或患者特定的植入部件一起使用。用于使用患者解剖结构、患者特定的假体部件以及患者特定的引导件的X射线、MRI或CT扫描获取患者的解剖结构的三维图像的计算机建模可由可例如通过密执安州(Mich)的普利茅斯(Plymouth)市的Materialize USA获得的多种CAD程序和/或软件提供。该引导件将允许外科医生精确地实施截骨术，这确保了植入物将匹配天然骨骼解剖结构并提供适当的调节量。
本文中所公开的患者特定的对准引导件以及相关的患者特定的植入物通常可利用基于从图像扫描产生的患者的三维解剖图像的计算机建模而形成。该患者特定的对准引导件可具有三维的患者特定的接合表面，该患者特定的接合表面被通过上文中讨论的计算机方法制成以与患者的骨骼表面(选择性地具有或不具有软组织)的三维图像一致地接触、配合和匹配。该患者特定的对准引导件可包括定制的引导结构(例如引导钻孔或引导孔隙)、可根据外科医生认可的术前计划被用于支撑或引导其它器械(例如钻引导件、铰刀、切除器以及切割引导件)或用于插入销或其它紧固件的插管式引导延伸部或容器。
在多个实施例中，该患者特定的对准引导件可包括用于将切割刀片接收于对应的患者特定的切割平面定向以及相对于用于特定患者的选定解剖轴线引导该切割刀的一个或多个患者特定的切割引导件。患者特定的对准引导件可还包括用于引导与截骨术手术相关的患者特定的植入物或现货供应的植入物的植入的引导构造，这些引导构造例如为可植入的楔形件和可植入的固定板。该患者特定的对准引导件的多种特征的几何结构、形状和定向以及多种患者特定的植入物及其它患者特定的工具可在该手术的术前计划阶段期间结合对患者解剖结构进行的计算机辅助建模来确定。在术前计划阶段期间，患者特定的对准引导件、植入物及其它工具可被针对特定患者利用来自与该外科手术相关的外科医生或其它专业人员的输入进行设计和制造，如授予Maxson等人的于2014年1月21日出版的美国专利No.8,632,547、授予Stone等人的于2012年8月14日出版的美国专利No.8,241,293以及Eash于2014年4月25日提交的美国专利申请No.14/262,105中所述，所有的这些文献都被通过引用结合到本文中。
在下列讨论中，术语“患者特定的”、“定制制造的”或“定制的”被限定为适用于包括工具、植入物、或其多个部分或组合的部件，这些部件包括某些几何特征，这些几何特征包括曲面(surface)、曲线或其它直线，并且这些部件被制成为在术前计划阶段期间基于通过计算机成像方法根据患者的图像扫描重建的对应的解剖结构的三维计算机图像而紧密地符合患者解剖结构的对应几何特征的镜像或底片像(negative)。此外，诸如引导孔隙和引导槽沟或被包括在对准引导件中或植入物中的其它孔或开口之类的患者特定的引导特征被定义为被基于与患者相关的计算机辅助的术前计划进行制造，以具有为特定患者的解剖结构所特有的位置、定向、尺寸、形状和/或限定为特定患者的解剖结构所特有的切割平面。
当前技术提供了一种如图1中所示的患者特定的胫骨截骨术引导件100。引导件100包括引导件本体102，该引导件本体102限定具有骨骼接合表面103的一部分，该骨骼接合表面103在胫骨截骨术的术前计划阶段期间被构造成作为负表面而与特定患者的胫骨104的对应表面保持一致。如图1中所示，引导件100被定位在特定患者的胫骨104上，围绕该胫骨104的内侧面上的结节108。在其它实施例中，引导件100可被构造成被定位在特定患者的胫骨104的外侧面上。骨骼接合表面103在术前计划阶段期间被定制以匹配特定患者的解剖结构并允许将引导件100放置在患者的胫骨104的近侧部分106处的特定位置处。通常，引导件100被构造成装配在特定患者的胫骨104上、在待于截骨术期间被复位的结节108处、围绕该结节108或位于该结节108附近的仅一个位置上并且与该进一个位置套置(nest)。
在一些实施例中，引导件本体102还限定允许清除软组织(例如韧带和肌腱)的软组织清除部分109。该软组织清除部分109具有外部凸起表面和内部凹入表面，其中，内部凹入表面提供了用于容置软组织的凹部。如图1中所示，软组织清除部分109容置患者的髌骨肌腱111。然而，在多种实施例中，该组织清除部分109容置内侧副韧带(MCL)113或外侧交叉韧带(LCL，未示出)。在这方面，骨骼接合表面103与胫骨104的特定骨骼区域相匹配且保持一致，并且髌骨软组织清除部分109允许将引导件同时放置在患者的软组织(例如髌骨肌腱111)的周围。在其它实施例中，引导件100包括用于同时容置LCL和髌骨肌腱或MCL和髌骨肌腱的多个组织清除部分109。
在附加实施例中，引导件本体102进一步限定软组织接合表面109’，其中，该软组织接合表面109’在胫骨截骨术的术前计划阶段期间被构造成作为负表面与特定患者的软组织在结节108处、围绕该结节108或在该结节108的附近的对应表面保持一致。例如，该软组织可以是患者的MCL、LCL或髌骨肌腱。在多种实施例中，引导件100包括用于同时容置LCL和髌骨肌腱或MCL和髌骨肌腱的多个软组织接合表面109’。在其它实施例中，引导件100既具有软组织清除部分109，又具有软组织接合表面109’。
引导件本体102进一步限定沿第一直线112定位的多个第一孔隙110，该第一直线112相对于特定患者的胫骨104的近侧-远侧轴线114限定第一预定角度θ1。在胫骨截骨术的术前计划阶段期间对第一直线112进行选择。在许多实施例中，多个第二孔隙116被沿第二直线118定位，该第二直线118相对于特定患者的胫骨104的近侧-远侧轴线114限定第二预定角度θ2，在胫骨截骨术的术前计划阶段期间对第二直线118进行选择，其中，第二线118与第一线112相交。在其它实施例中，多个第三孔隙120被沿第三直线122定位，该第三直线122相对于特定患者的胫骨104的近侧-远侧轴线114限定第三预定角度θ3，在胫骨截骨术的术前计划阶段期间对第三直线122进行选择，其中，第三线122与第二线118相交。
这多个第一孔隙110、多个第二孔隙116和多个第三孔隙120被构造成将多个销124引导到胫骨104，用于插入。这多个孔隙110、116、120具有直径D1并且销124具有直径D2，其中D1大于D2。由于孔隙110、116、120与销124相比具有较大的直径，因此可通过仅使引导件100从植入销124上滑落而从胫骨104上移除引导件100。当移除引导件100时，销124提供了锯引导件(saw guide)，该锯引导件用于切除胫骨104中的位于销124之间的邻近于销124的平面，以产生如图3、图4和图6中所示的结节皮瓣132。因此，该锯引导件邻近于销124并匹配在术前计划阶段期间构造的线112、118、122。换句话说，销124为制成贯穿胫骨104的三个相交的平面切口向医生提供视觉标记。
如图2中所示，在多种实施例中，本技术提供一种分叉的患者特定的对准引导件150，该对准引导件150包括第一引导件半部150a，该第一引导件半部150a在接缝152处以可移除的方式联接到第二引导件半部150b。该分叉的患者特定的对准引导件的第一半部150a具有与如图1和图3中所示的对准引导件100相似的特征，例如用于将多个销124引导到胫骨104的多个孔隙110、116、120。可选择地，引导件的第二半部150b还可具有用于将销124引导到胫骨104的多个孔隙110’、116’和120’。该分叉的引导件150具有与骨骼(boney)结构套置且与该骨骼结构保持一致的至少一个骨骼接合表面154。该骨骼结构可以是位于胫骨104上或位于腓骨105上的结构。在其它实施例中，分叉的引导件150具有与至少一个软组织套置并与该软组织保持一致或提供对于该至少一个软组织的清除的至少一个软组织接合表面156，该至少一个软组织例如为从包括患者的MCL 113、LCL 115、髌骨肌腱111及其组合的组中选择的软组织。在其它实施例中，分叉的引导件150具有至少一个骨骼接合表面154和至少一个软组织接合表面156。与不包括两个半部的引导件相比，第二引导件半部150b允许引导件150与更多的骨骼结构和/或软组织结构套置且与其保持一致。在已将销124定位到胫骨104中之后，分叉的引导件150可被在接缝152处分离开，这允许第一半部150a和第二半部150b在销124上滑动远离该胫骨104。参照图6A，本技术提供一种患者特定的植入物或楔形件200a，其在胫骨结节截骨术的术前计划阶段期间被构造成被塞(wedged)在空隙中以保持住患者的胫骨结节108相对于胫骨104的位置，该空隙通过由患者特定的引导件100引导的切除术产生。患者特定的植入物200包括第一部分202，该第一部分202具有对应于图1中所示的线112的第一表面204。由于第一表面204对应于线112，因此植入物200a被定制设计以装配在通过由患者特定的引导件100引导的切除术产生的空隙中。在一些实施例中，植入物200a进一步包括可选择的第二部分206，该第二部分206具有对应于图1中所示的线118的第二表面208。由于第一表面204对应于线112，并且由于第二表面208对应于线118，因此具有第一部分202和第二部分206的植入物200a被定制设计成装配在通过由患者特定的引导件100引导的切除术产生的空隙中。在其它实施例中，植入物200a进一步包括可选择的第三部分210，该第三部分210具有对应于图1中所示的线122的第三表面212。由于第一表面204对应于线112，第二表面208对应于线118，并且第三表面212对应于线122，因此具有第一部分202、第二部分206和第三部分210的植入物200a被定制设计成装配在通过由患者特定的引导件100引导的切除术产生的空隙中。患者特定的植入物可由促进骨骼向内生长的材料构成。图6B是一种类似于植入物200a的第二患者特定的植入物200b。然而，第二植入物200b进一步包括被联接到第一部分202的大致呈球形的部分214。球形部分214被设计成装配在铰接孔或应力消除孔中，如下文中进一步所述。
参照图1，本技术提供了一种用于在患者的胫骨104上利用患者特定的对准引导件100实施胫骨结节截骨术的方法。该方法包括将该患者特定的引导件100在结节108处、在该结节108的附近或围绕该结节108定位在患者的胫骨104上，其中，引导件100包括引导件本体102，该引导件本体102限定具有骨骼接合表面的一部分并且沿线112限定多个第一孔隙110，该骨骼接合表面在胫骨截骨术的术前计划阶段期间被构造成作为负表面与患者的胫骨104的对应表面保持一致。如上所述，在一些实施例中，引导件本体102进一步沿线118限定多个第二孔隙116并且沿线122限定多个第三孔隙120。因此，孔隙110、116、120被定位在三条相交的直线112、118、122中，这三条直线相对于在胫骨截骨术的术前计划阶段期间所选择的患者的胫骨104的近侧-远侧轴线114限定三个预定角度81、82、83。引导件100被定制成在近端106处、在结节108处或该结节108的附近与特定患者的胫骨104相匹配并且与其保持一致。该方法还包括将多个销124穿过多个第一孔隙110插入到可选择的多个第二孔隙116和多个第三孔隙120中以及插入到患者的胫骨104中。图3示出了被定位在特定患者的胫骨104上的引导件100，其中，销124已被穿过多个第一孔隙110、多个第二孔隙116、多个第三孔隙120放置到胫骨104中。
在已将销124插入到胫骨104中之后，该方法包括将引导件100从胫骨104上移除。由于孔隙110、116、120的直径D1大于销124的直径D2，因此该引导件100可通过仅使引导件100在销124上滑动而被移除。
参照图4，当将销124插入到胫骨104中并且已将引导件100移除时，该方法包括在胫骨104中邻近于与第一线112成一直线的销124切除第一平面126。可选择地，可在胫骨104中邻近于最远侧销124钻出诸如铰接孔或应力消除孔之类的钻孔，其中，该第一平面126被从该钻孔到邻近于第一线112的最近侧销124切除掉。因此，销124提供了用于在胫骨104中邻近于销124，在销124之间切除该第一平面126的锯引导件。同样，切除进一步包括在胫骨104中邻近于与第二线118成一直线的销124切除第二平面128，并且在胫骨104中邻近于与第三线122成一直线的销124切除第三平面130。例如使用振荡锯来实施切除。当已经切除了所有三个平面126、128、130时，产生结节皮瓣132。因此，在胫骨104中被切除的平面126、128、130邻近于并且匹配在术前计划阶段期间被构造的线112、118、122。
如图5中所示，在切除之后，该方法包括从胫骨104上移除销124。当移除销124时，孔134保持在胫骨104中。在已经产生结节皮瓣132之后，该方法包括在前部方向中或在前部方向和内侧-外侧方向中复位结节皮瓣132以便在结节皮瓣132和胫骨138的三个切除表面138、140、142之间形成空隙136。复位结节皮瓣132改变了患者的髌骨的位置，以移除疼痛引起的载荷并导致缓解了以髌骨相对于无症状个体的错乱排列为特征的髌股状况。结节皮瓣132被复位到在术前计划阶段期间预定的位置。在复位结节皮瓣132之后，该方法包括将患者特定的植入物或楔形件200a植入或定位在植入空隙136中，如图6A和图7中所示。在于胫骨104中钻出铰接孔或应力消除孔的实施例中，利用如图6B中所示的植入物或楔形件200b。如上所述，患者特定的植入物200a具有在术前计划阶段期间构造的预定形状。植入物200a包括第一部分202以及可选择地包括第二部分206或第二部分206和第三部分210。在一些实施例中，患者特定的植入物由促进骨骼向内生长的材料构成。在替代方法中，植入物是现货供应的(即，非患者特定的)可植入楔形件。可选择地，该方法包括通过将螺钉穿过结节皮瓣132和楔形件200a并穿过切除表面138、140、142之一驱动到胫骨104中，固定住结节皮瓣132。楔形件200a维持复位后的结节皮瓣132的位置并防止该结节皮瓣132回复到其初始位置。
当前技术提供了如图8中所示的另一患者特定的胫骨截骨术引导件300。引导件300包括引导件本体302，该引导件本体302限定具有骨骼接合表面303的一部分，该骨骼接合表面303在胫骨截骨术的术前计划阶段期间被构造成作为负表面与特定患者的胫骨104的对应表面保持一致。如图8中所示，该引导件300被围绕胫骨104的内侧面上的结节108定位在特定患者的胫骨104上。在其它实施例中，引导件300可被构造成被定位在特定患者的胫骨104的外侧面上。该骨骼接合表面303在术前计划阶段期间被定制成匹配特定患者的解剖结构并允许将引导件300放置于患者的胫骨104的近侧部分106处的特定位置处且仅处于一个位置中。通常，该引导件300被构造成在待于截骨术期间被复位的结节108处、围绕该结节108或在该结节108的附近装配在特定患者的胫骨104上。
在一些实施例中，引导件本体302还限定允许清除软组织的软组织清除部分309，该软组织例如为韧带和肌腱。该软组织清除部分309具有外部凸起表面和内部凹入表面，其中，该内部凹入表面提供了用于容置软组织的凹部。如图8中所示，该软组织清除部分309容置患者的髌骨肌腱111。然而，在多种实施例中，该组织清除部分309容置内侧副韧带(MCL)113或外侧交叉韧带(LCL，未示出)。在这方面，骨骼接合表面303与胫骨104的特定的骨骼区域相匹配且于其保持一致，并且髌骨软组织清除部分309允许将引导件同时放置在患者的软组织(例如髌骨肌腱111)周围。在其它实施例中，引导件300包括用于同时容置LCL和髌骨肌腱或MCL和髌骨肌腱的多个组织清除部分309。
在附加实施例中，引导件本体302进一步限定软组织接合表面309’，其中，该软组织接合表面309’在胫骨截骨术的术前计划阶段期间被构造成作为负表面与特定患者的软组织在结节108处、围绕该结节108或在该结节108的附近的对应表面保持一致。例如，该软组织可以是患者的MCL、LCL或髌骨肌腱。在多种实施例中，引导件300包括用于同时容置LCL和髌骨肌腱或MCL和髌骨肌腱的多个软组织接合表面309’。在其它实施例中，引导件300既具有软组织清除部分309，又具有软组织接合表面309’。
引导件本体302进一步限定沿第四直线306定位的第一平面槽沟304，该第四直线相对于特定患者的胫骨104的近侧-远侧轴线114限定第四预定角度84。该第四直线306在胫骨截骨术的术前计划阶段期间进行选择。因此，第一平面槽沟304被相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨104的近侧-远侧轴线114以第四预定角度84定向于第一预定位置。由引导件本体302限定的第一平面槽沟304具有远端308和近端310，其中，该引导件本体302进一步限定与第一远端308连通的圆形槽沟312。
此外，引导件本体302限定沿第五直线316定位的第二平面槽沟314，该第五直线316相对于特定患者的胫骨104的近侧-远侧轴线114限定第五预定角度θ5。该第五直线316在胫骨截骨术的术前计划阶段期间进行选择。因此，第二平面槽沟314被相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨104的近侧-远侧轴线114以第五预定角度θ5定向于第二预定位置。
此外，引导件本体302限定沿第六直线317定位的第三平面槽沟315，该第六直线317相对于特定患者的胫骨104的近侧-远侧轴线114限定第六预定角度θ6。该第六直线317在胫骨截骨术的术前计划阶段期间进行选择。因此，第三平面槽沟315被相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨104的近侧-远侧轴线114以第六预定角度θ6定向于第三预定位置。
患者特定的引导件300的引导件本体302还限定用于将引导件300可移除地锚固到特定患者的胫骨104的多个孔隙318。这些孔隙具有直径D3并且销具有直径D4，其中，D3小于D4。由于孔隙318具有比销320小的直径，也因此引导件300可通过将销320穿过孔隙318插入到胫骨104中，而被附接到胫骨104。为了从胫骨104上移除该引导件300，必须首先移除销320。
本技术还提供了一种用于使用患者特定的引导件300在患者的胫骨上实施胫骨结节截骨术的方法。如图8中所示，该方法包括通过将销320穿过孔隙318插入到胫骨104中，将引导件300锚固到患者的胫骨104。当将引导件300锚固在适当位置中时，该方法包括将钻头插入穿过圆形槽沟312并穿过胫骨104钻出圆形铰接孔或应力消除孔322。
在钻孔之后，该方法包括将锯条插入穿过第一槽沟304以及从钻孔322到第一槽沟304的近端310切除第一平面324。同样，该方法包括将锯条插入穿过第二槽沟314并切除第二平面326，以及将锯条插入穿过第三槽沟315并切除第三平面328。例如可使用振荡锯来实施切除。在已将平面324、326、328经由引导件300中的槽沟304、314、315穿过胫骨104切除之后，该方法包括从胫骨104上移除销320，这暴露出销孔321，并且随后移除引导件300。如图9中所示，在已将引导件300移除之后，该方法包括切除胫骨104以将第一平面324连接到第二平面326，将第二平面326连接到第三平面328，以及将第三平面328连接到胫骨104的靠近结节108的前表面104，以便形成邻近于胫骨的切除表面的结节皮瓣330。
如图10中所示，在已产生结节皮瓣330之后，该方法包括使结节皮瓣330在前部方向中或在前部方向和内侧-外侧方向中复位，以便在结节皮瓣330和胫骨104的三个切除表面332、334、336之间形成空隙338。铰接孔或应力消除孔322确保复位结节皮瓣330并不会使胫骨104断裂或碎裂。将结节皮瓣330复位到在术前计划阶段期间预定的位置。复位结节皮瓣132改变了患者的髌骨的位置，从而移除了疼痛导致的载荷并且导致缓解了以髌骨相对于无症状个体的错乱排列为特征的髌股状况。在复位结节皮瓣330之后，该方法包括将患者特定的植入物或楔形件200a、200b植入或定位在空隙136中，如图6A、图6B和图11中所示。如上所述，患者特定的植入物200a、200b具有在术前计划阶段期间构造的预定形状。植入物200a、200b包括第一部分202以及可选择地包括第二部分206或第二部分206和第三部分210。在一些实施例中，患者特定的植入物200a、200b由促进骨骼向内生长的材料构成。当使用第二植入物200b时，球形部分214被定位在应力消除孔322中。在替代方法中，植入物是现货供应的(即，非患者特定的)可植入楔形件。可选择地，该方法包括通过将螺钉340穿过结节皮瓣330和楔形件200a、200b并穿过切除表面332之一驱动到胫骨104中，而固定住该结节皮瓣330。楔形件200a、200b保持复位后的结节皮瓣330相对于胫骨104的位置并防止该结节皮瓣330回复到其初始位置。
本技术另外提供了一种包括患者特定的引导件的用于胫骨截骨术的手术套件或系统，该患者特定的引导件包括：引导件本体，该引导件本体限定：具有骨骼接合表面的一部分，该骨骼接合表面作为负表面与特定患者的胫骨的对应表面保持一致；以及引导部分，该引导部分将手术器械引导到特定患者的胫骨上的特定位置，其中，在术前计划阶段期间构造该骨骼接合表面和该引导部分；具有预定形状的患者特定的可植入楔形件，其中，在术前计划阶段期间构造该楔形件；以及多个销。
下列非限制性的示例列表可进一步图示出用于胫骨截骨术的本患者特定的系统以及用于在患者的胫骨上实施胫骨结节截骨术的方法。
在示例1中，一种用于胫骨截骨术的患者特定的系统可包括患者特定的引导件，该患者特定的引导件包括：引导件本体，该引导件本体限定：具有骨骼接合表面的骨骼接合部分，该骨骼接合表面作为负表面与特定患者的胫骨的对应表面保持一致；以及引导部分，该引导部分将手术器械引导到特定患者的胫骨上的特定位置，其中，可在术前计划阶段期间构造该骨骼接合表面和该引导部分；具有预定形状的患者特定的可植入楔形件，其中，可在术前计划阶段期间构造该楔形件；以及多个销。
在示例2中，根据示例1所述的患者特定的系统可被可选择地构造成，使得该引导部分可包括由该引导件本体限定的多个孔隙，其中，这多个孔隙可被构造成将该销引导到该特定患者的胫骨，其中，销被用作用于切除特定患者的胫骨的锯引导件。
在示例3中，根据示例2所述的患者特定的系统可被可选择地构造成，使得孔隙可被定位在三条直线上，这三条直线相对于在胫骨截骨术的术前计划阶段期间选择的患者的胫骨的近侧-远侧轴线限定三个预定角度。
在示例4中，根据示例1-3中的任一个所述的患者特定的系统可被可选择地构造成，使得该引导部分可包括：由该引导件本体限定的第一平面槽沟，该第一平面槽沟被相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线以第一预定角度定向于第一预定位置；以及由该引导件本体限定的第二平面槽沟，该第二平面槽沟被相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线以第二预定角度定向于第二预定位置。
在示例5中，根据示例1-4中的任一个所述的患者特定的系统可被可选择地构造成，使得由该引导件本体限定的第一平面槽沟具有远端和近端，并且其中，该引导件本体进一步限定与该第一远端连通的圆形槽沟。
在示例6中，根据示例1-5中的任一个所述的患者特定的系统可被可选择地构造成，使得该引导件本体可进一步限定软组织接合表面，其中，该软组织接合表面在胫骨截骨术的术前计划阶段期间被构造成作为负表面与特定患者的内侧副韧带、外侧交叉韧带或髌骨肌腱的对应表面保持一致。
在示例7中，一种用于胫骨截骨术的患者特定的系统可包括：患者特定的引导件，该引导件可选地包括引导件本体，该引导件本体限定具有骨骼接合表面的骨骼接合部分，该骨骼接合表面在胫骨截骨术的术前计划阶段期间被构造成作为负表面与特定患者的胫骨的在患者的胫骨结节处、在该胫骨结节周围或在该胫骨结节附近的对应表面保持一致；以及沿第一直线定位的多个第一孔隙，该第一直线相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线限定第一预定角度。
在示例8中，根据示例7所述的患者特定的系统可被可选择地构造成，使得这多个孔隙被构造成对多个销在胫骨中的插入进行引导。
在示例9中，根据示例7到8中的任一个所述的患者特定的系统可被可选择地构造成，使得这多个孔隙的直径大于销的直径。
在示例10中，根据示例7-9中的任一个所述的患者特定的系统可以可选择的方式进一步包括沿第二直线定位的多个第二孔隙，该第二直线相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线限定第二预定角度，其中，该第二线与该第一线相交。
在示例11中，根据示例7-10中的任一个所述的患者特定的系统可以可选择的方式进一步包括沿第三直线定位的多个第三孔隙，该第三直线相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线限定第三预定角度，其中，该第三线与该第二线相交。
在示例12中，根据示例7-11中的任一个所述的患者特定的系统可被可选择地构造成，使得该引导件本体进一步限定软组织接合表面，其中，该软组织接合表面在胫骨截骨术的术前计划阶段期间被构造成作为负表面与特定患者的软组织在结节处或围绕该结节的对应表面保持一致。
在示例13中，根据示例7-12中的任一个所述的患者特定的系统可被可选择地构造成，使得该特定患者的软组织是患者的内侧副韧带、外侧交叉韧带或髌骨肌腱。
在示例14中，根据示例7-13中的任一个所述的患者特定的系统可被可选择地构造成，使得该引导件本体进一步限定包括外部凸起表面和内部凹入表面的软组织清除部分，其中，该内部凹入表面提供了用于容置患者的内侧副韧带、外侧交叉韧带或髌骨肌腱的凹部。
在示例15中，根据示例7-14中的任一个所述的患者特定的系统可被可选择地构造成，使得通过具有该骨骼接合表面的骨骼接合部分，该引导件与该特定患者的胫骨上在该结节处、围绕该结节或在该结节的附近的仅一个特定位置相匹配并且与该仅一个特定位置保持一致。
在示例16中，一种用于胫骨截骨术的患者特定的系统可以可选择的方式包括：包括引导件本体的患者特定的引导件，该引导件本体限定具有骨骼接合表面的骨骼接合部分，其中，该骨骼接合表面在胫骨截骨术的术前计划阶段期间被构造成作为负表面与特定患者的胫骨在患者的胫骨结节处、围绕该胫骨结节或在该胫骨结节的附近的对应表面保持一致；第一平面槽沟，该第一平面槽沟被相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线以第一预定角度定向于第一预定位置；以及第二平面槽沟，该第二平面槽沟被相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线以第二预定角度定向于第二预定位置；以及多个孔隙。
在示例17中，根据示例16所述的患者特定的系统可被可选择地构造成，使得由该引导件本体限定的第一平面槽沟具有远端和近端，并且其中，该引导件本体进一步限定与该第一远端连通的圆形槽沟。
在示例18中，根据示例16-17中的任一个所述的患者特定的系统可被可选择地构造成，使得这多个孔隙被构造成接受用于在该患者的胫骨结节附近的单个位置处将该引导件可移除地锚固到该特定患者的胫骨的多个销。
在示例19中，根据示例16-18中的任一个所述的患者特定的系统可被可选择地构造成，使得该引导件本体进一步限定软组织接合表面，其中，该软组织接合表面在胫骨截骨术的术前计划阶段期间被构造成作为负表面与特定患者的软组织在结节处或在该结节附近的对应表面保持一致。
在示例20中，根据示例16-19中的任一个所述的患者特定的系统可被可选择地构造成，使得该特定患者的软组织是患者的内侧副韧带、外侧交叉韧带或髌骨肌腱。
在示例21中，根据示例16-20中的任一个所述的患者特定的系统可被可选择地构造成，使得该引导件本体进一步限定包括外部凸起表面和内部凹入表面的软组织清除部分，其中，该内部凹入表面提供用于容置患者的内侧副韧带、外侧交叉韧带或髌骨肌腱的凹部。
在示例22中，一种用于在患者的胫骨上实施胫骨结节截骨术的方法可包括：将患者特定的引导件定位在患者的胫骨上，其中，该引导件包括引导件本体，该引导件本体限定具有骨骼接合表面的骨骼接合部分，该骨骼接合表面在胫骨截骨术的术前计划阶段期间被构造成作为负表面与特定患者的胫骨在患者的胫骨的结节处、围绕该结节或在该结节的附近的对应表面保持一致，并且该引导本体限定多个孔隙；利用锯在三个交叉平面中切除胫骨以产生结节皮瓣，其中，该患者特定的引导件为切除提供视觉标记；以及使该结节皮瓣在前部方向中或在前部方向和内侧-外侧方向中复位以便在该结节皮瓣和胫骨的切除表面之间形成空隙。
在示例23中，根据示例22所述的方法可以可选择的方式进一步包括将楔形件植入在该空隙中，其中，该楔形件具有在术前计划阶段期间构造的预定形状，并且其中，该楔形件由促进骨骼向内生长的材料构成。
在示例24中，根据示例22-23中的任一个所述的方法可以可选择的方式进一步包括通过将螺钉穿过该结节皮瓣和该楔形件并通过切除表面驱动到胫骨中，而将该结节皮瓣相对于胫骨的切除表面固定住。
在示例25中，根据示例22-24中的任一个所述的方法可被以可选择的方式构造成，使得将这多个孔隙沿三条相交的线定位，该三条相交的线相对于在胫骨截骨术的术前计划阶段期间选择的患者的胫骨的近侧-远侧轴线限定三个预定角度，并且其中，该方法可以可选择的方式进一步包括：将该多个销插入穿过孔隙，这些销具有比孔隙的直径小的直径；以及移除该患者特定的引导件，其中，销为切除提供视觉标记。
在示例26中，根据示例22-25中的任一个所述的方法可被以可选择的方式构造成，使得该引导件本体进一步限定第一平面槽沟，该第一平面槽沟被相对于在胫骨截骨术的术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线以第一预定角度定向于第一预定位置，其中，由该引导件本体限定的该第一平面槽沟具有远端和近端，该引导件本体进一步限定与该第一远端连通的圆形槽沟，并且其中，该方法可以可选择的方式进一步包括：通过将该销穿过孔隙插入到胫骨中而将该引导件在该结节附近锚固于该患者的胫骨；将钻头插入穿过该圆形槽沟并穿过胫骨钻出孔；通过将锯插入穿过该第一槽沟来穿过胫骨切除第一平面；通过将锯插入穿过该第二槽沟来穿过胫骨切除第二平面；移除销和该引导件；进一步切除该胫骨以将该第一平面和该第二平面相连；以及穿过胫骨切除第三平面以将该第二平面联接到该胫骨的前表面，以便形成结节皮瓣。
在示例27中，根据示例22-26中的任一个所述的方法可被可选择地构造成，使得该引导件本体进一步限定包括外部凸起表面和内部凹入表面的软组织清除部分，并且其中，将该患者特定的引导件定位在患者的胫骨上进一步包括将该引导件的骨骼接合表面套置到胫骨上的对应表面上，其中，该软组织清除部分的内部凹入表面提供用于容置患者的内侧副韧带、外侧交叉韧带或髌骨肌腱的凹部。
在示例28中，根据示例1-27中的任一个或任意组合所述的患者特定的系统或方法可被可选择地构造成，使得所述的所有元件、操作或其它选择方案都是可获得或可从中进行选择。

Claims (23)

1.一种用于胫骨截骨术的患者特定的系统，包括：包括引导件本体的患者特定的引导件，所述引导件本体限定：
具有骨骼接合表面的骨骼接合部分，所述骨骼接合表面在所述胫骨截骨术的术前计划阶段期间被构造成作为负表面与特定患者的胫骨的对应表面保持一致；以及
引导部分，所述引导部分相对于在所述胫骨截骨术的所述术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线限定第一预定角度。
2.根据权利要求1所述的患者特定的系统，其中，所述引导件本体的所述引导部分限定沿第一直线定位的多个第一孔隙。
3.根据权利要求2所述的患者特定的系统，其中，所述多个孔隙被构造成对多个销到所述胫骨中的插入进行引导。
4.根据权利要求3所述的患者特定的系统，其中，所述多个孔隙具有比所述销的直径大的直径。
5.根据权利要求3-4中的任一项所述的患者特定的系统，其中，所述患者特定的系统进一步包括所述多个销。
6.根据权利要求5所述的患者特定的系统，其中，当被插在所述胫骨中时，所述销被定位成提供用于在特定患者的胫骨中邻近于所述销切除平面的锯引导件。
7.根据权利要求2-6中的任一项所述的患者特定的系统，其中，所述引导件本体进一步限定沿第二直线定位的多个第二孔隙，所述第二直线相对于在所述胫骨截骨术的所述术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线限定第二预定角度，其中，所述第二线与所述第一线相交。
8.根据权利要求7所述的患者特定的系统，其中，所述引导件本体进一步限定沿第三直线定位的多个第三孔隙，所述第三直线相对于在所述胫骨截骨术的所述术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线限定第三预定角度，其中，所述第三线与所述第二线相交。
9.根据权利要求1所述的患者特定的系统，其中，所述引导件本体的所述引导部分限定第一平面槽沟，所述第一平面槽沟被相对于在所述胫骨截骨术的所述术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线以第一预定角度定向于第一预定位置。
10.根据权利要求9所述的患者特定的系统，其中，
所述第一平面槽沟具有远端和近端；以及
所述引导件本体进一步限定与所述第一平面槽沟的所述远端连通的圆形槽沟。
11.根据权利要求9-10中的任一项所述的患者特定的系统，其中，所述引导件本体进一步限定第二平面槽沟，所述第二平面槽沟被相对于在所述胫骨截骨术的所述术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线以第二预定角度定向于第二预定位置。
12.根据权利要求1-11中的任一项所述的患者特定的系统，其中，所述引导件本体进一步限定软组织接合表面，所述软组织接合表面在所述胫骨截骨术的所述术前计划阶段期间被构造成作为负表面与特定患者的软组织在所述结节处或围绕所述结节的对应表面保持一致。
13.根据权利要求1-12中的任一项所述的患者特定的系统，其中，所述引导件本体进一步限定包括外部凸起表面和内部凹入表面的软组织清除部分，其中，所述内部凹入表面提供用于容置患者的内侧副韧带、外侧交叉韧带或髌骨肌腱的凹部。
14.根据权利要求1-13中的任一项所述的患者特定的系统，其中，通过具有所述骨骼接合表面的所述骨骼接合部分，所述引导件与特定患者的胫骨上位于所述结节处、围绕所述结节或位于所述结节的附近的仅一个特定位置相匹配且保持一致。
15.根据权利要求14所述的患者特定的系统，其中，所述患者特定的系统进一步包括具有预定形状的患者特定的可植入楔形件，其中，所述楔形件在所述胫骨截骨术的所述术前计划阶段期间被构造成被塞在空隙中以保持所述特定患者的胫骨结节相对于所述特定患者的胫骨的位置，所述空隙通过由所述引导件本体引导的切除术产生。
16.一种用于胫骨截骨术的患者特定的系统，其中，所述系统包括：包括引导件本体的患者特定的引导件，所述引导件本体限定：
具有骨骼接合表面的骨骼接合部分，所述骨骼接合表面在所述胫骨截骨术的术前计划阶段期间被构造成作为负表面与特定患者的胫骨的对应表面保持一致，其中，所述具有骨骼接合表面的骨骼接合部分与特定患者的胫骨上的位于结节处、围绕所述结节或位于所述结节的附近的仅一个特定位置相匹配且保持一致；以及
定位在三条直线上的多个孔隙，所述三条直线相对于在所述胫骨截骨术的所述术前计划阶段期间选择的患者的胫骨的近侧-远侧轴线限定三个预定角度。
17.根据权利要求16所述的患者特定的系统，其中，所述患者特定的系统进一步包括具有比所述孔隙的直径小的直径的多个销，所述销被构造成穿过所述孔隙插在所述胫骨中，使得当被插在所述胫骨中时，所述销被定位成提供用于在特定患者的胫骨中邻近于所述销切除平面的锯引导件。
18.一种用于在患者的胫骨上实施胫骨结节截骨术的方法，包括：
将患者特定的引导件定位在患者的胫骨上，其中，所述引导件包括引导件本体，所述引导件本体限定：具有骨骼接合表面的骨骼接合部分，所述骨骼接合表面在胫骨截骨术的术前计划阶段期间被构造成作为负表面与患者胫骨的位于患者的胫骨的结节处、围绕所述结节或位于所述结节的附近的对应表面保持一致；以及多个孔隙；
利用锯在三个交叉平面中切除所述胫骨以产生结节皮瓣，其中，所述患者特定的引导件为切除提供视觉标记；以及
使所述结节皮瓣在前部方向中或在前部方向和内侧-外侧方向中复位，以便在所述结节皮瓣和所述胫骨的切除表面之间形成空隙。
19.根据权利要求18所述的方法，其中，所述方法进一步包括：
在所述空隙中植入楔形件；
其中，所述楔形件具有在所述术前计划阶段期间构造的预定形状，并且，所述楔形件由促进骨骼向内生长的材料构成。
20.根据权利要求18-19中的任一项所述的方法，其中，所述方法进一步包括通过将螺钉穿过所述结节皮瓣和所述楔形件并穿过所述切除表面驱动到所述胫骨中，而将所述结节皮瓣相对于所述胫骨的所述切除表面固定住。
21.根据权利要求18-20中的任一项所述的方法，其中：
沿三条相交的线定位所述多个孔隙，所述三条相交的线相对于在所述胫骨截骨术的所述术前计划阶段期间选择的患者的胫骨的近侧-远侧轴线限定三个预定角度，并且
所述方法进一步包括：
将多个销插入穿过所述孔隙，所述销具有比所述孔隙的直径小的直径；以及
移除所述患者特定的引导件，
其中，所述销为切除提供视觉标记。
22.根据权利要求18所述的方法，其中：
所述引导件本体进一步限定第一平面槽沟，所述第一平面槽沟被相对于在所述胫骨截骨术的所述术前计划阶段期间选择的特定患者的胫骨的近侧-远侧轴线以第一预定角度定向于第一预定位置；
由所述引导件本体限定的所述第一平面槽沟具有远端和近端，所述引导件本体进一步限定与所述第一远端连通的圆形槽沟，以及
所述方法进一步包括：
通过将所述销穿过所述孔隙插入到所述患者的胫骨中，而将所述引导件在所述结节的附近锚固到所述胫骨中；
将钻头插入穿过所述圆形槽沟并穿过所述胫骨钻孔；
通过将锯插入穿过所述第一槽沟，而穿过所述胫骨切除第一平面；
通过将锯插入穿过所述第二槽沟，而穿过所述胫骨切除第二平面；
移除所述销和所述引导件；
进一步切除所述胫骨以便将所述第一平面和所述第二平面相连；以及
穿过所述胫骨切除第三平面以便将所述第二平面联接到所述胫骨的前表面，从而形成所述结节皮瓣。
23.根据权利要求18-22中的任一项所述的方法，其中：
所述引导件本体进一步限定包括外部凸起表面和内部凹入表面的软组织清除部分，以及
将所述患者特定的引导件定位在所述患者的胫骨上进一步包括将所述引导件的所述骨骼接合表面套置到所述胫骨上的对应表面上；以及
所述软组织清除部分的所述内部凹入表面提供了用于容置所述患者的内侧副韧带、外侧交叉韧带或髌骨肌腱的凹部。
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