CN102405024B - 患者专用的手术引导件定位器及安装件 - Google Patents

患者专用的手术引导件定位器及安装件 Download PDF

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CN102405024B
CN102405024B CN201080017342.4A CN201080017342A CN102405024B CN 102405024 B CN102405024 B CN 102405024B CN 201080017342 A CN201080017342 A CN 201080017342A CN 102405024 B CN102405024 B CN 102405024B
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M·卡罗尔
R·奥博特
P·斯特姆尼斯基
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Abstract

一种切除引导件定位器(20)，其包括骨骼接合部(30，31)，该骨骼接合部具有与在手术期间要被切除的骨骼的表面形貌互补的表面(36，40)。壳体(49)包括由弹性环形壁(55)限定的插口(58)，设定所述弹性环形壁的尺寸和布置方式，从而通过压配合的方式接纳切除引导件(26)，从而将切除引导件定位和保持在插口内。在所述表面以可释放的方式在骨骼上锁定就位的同时，切除引导件被保持在预定的优选位置。还公开了一种用于形成和使用切除引导件定位器的方法。

Description

患者专用的手术引导件定位器及安装件
本申请涉及于2009年2月24日提交的名称为“PatientSpecificSurgicalGuideMount”的第61/154,845号美国临时专利申请、以及于2010年2月23日提交的名称为“PatientSpecificSurgicalGuideLocatorandMount”的第12/710,898号美国专利申请，并且要求上述专利申请的权益。
技术领域
本发明大致涉及手术引导件，以及用于在诸如全膝、髋关节或踝关节置换手术的矫形过程中相对于患者身体定位上述引导件的固定装置，以及用于设计和使用上述器械定位器的方法。
背景技术
在现有技术中，全关节(膝、髋以及踝)置换假体是已知的。在很多情况中，专门设计的夹具或固定装置使得外科医生能够对股骨表面、胫骨表面或这二者进行准确和精确的骨骼切除，以便接纳上述假体。任何全关节假体的最终目的都是模拟假体所要替代的自然健康结构的功能。如果假体没有被恰当地附接到股骨、胫骨、踝关节或足部，则任何不对准都有可能导致患者不舒服、步态问题或假体性能的降低。
例如，当附接膝假体时，期望将假体定向成使得膝关节的枢转轴线位于被大致定向成垂直于股骨的机械轴线的横向平面内。机械轴线沿着与踝关节的中心及股骨头交叉的线延伸。在现有技术中，机械轴线是在手术之前或甚至是在手术中通过检查要切除的股骨的X光照片来确定的。在实际的操作中，通过计算机械轴线从股骨轴线的外翻角来确定机械轴线。于是，需要相对于股骨轴线手动地对准任何切割引导件及其固定装置以便实现最优的切割。
通常，上述切割引导件包括股骨髓内杆，该股骨髓内杆穿过在髁间凹口中形成的预钻削的通路而被插入并沿着股骨轴线向上穿过股骨。所述杆通常包括支撑远侧股骨切割引导件的托架。所述托架包括延伸穿过切割引导件以用作枢转轴线的第一销钉。第二销钉被附接到托架，以便延伸穿过切割引导件中的弓形槽。切割引导件包括沿着其侧边形成的成对的对置槽，这些槽被定向成垂直于切割引导件的中心对称轴。当切割引导件枢转，使得中心对称轴沿着机械轴线延伸，以便与股骨轴线形成适当时角度时，切割引导件的槽被定位成垂直于机械轴线。然后，切割引导件与股骨轴线被锁定到预定的角度。
在最近，计算机辅助设计技术已经与成像技术的发展相结合，用以改进关节置换假体和方法。例如，在第5,735,277号的美国专利中，公开了一种制造用于关节置换的内用假体的工艺，在这种工艺中，通过比较受损伤的膝关节的矫正的术前图像与术后图像，获得用于确定股骨和胫骨的轮廓差别的基准图像。后来，这种技术被用作用于制备内用假体的对应的股骨和胫骨部件的基础。
在第6,944,518号的美国专利中，公开了一种用于制造关节假体的方法，在这种方法中，使用来自患者关节的计算机X射线断层造影，通常被称为CAT扫描(CT)数据来设计假体。将CT数据下载到计算机辅助设计软件中，以便至少设计假体的附接件，并且可能的话设计假体的功能件。附接件可用于将功能件附接到或以其他方式关联到患者骨骼。
在第5,370,692号的美国专利中，公开了一种用于制造假体骨骼植入物的方法，在该方法中，通过可利用的成像技术(计算机X射线断层造影、核磁共振成像或类似技术)的归档利用(archivaluse)，使用成像技术来限定发生创伤之前(“创伤前”文件)的硬组织特征(尺寸、形状、孔隙率等)。通过对损伤后的受影响组织的位置进行成像(“创伤后”文件)来确定硬组织的损失。通过对创伤前文件和创伤后文件进行比较来具体指定定制的假体设备的物理属性，以产生实体模型“设计”文件。该具体指定可能还涉及文件的二次操作以辅助手术植入并补偿预期的愈合过程。对设计文件进行数学处理，以产生“切片文件”，该“切片文件”然后被用于指导制造系统以生物相容的材料来构造设计文件的精确的复制品以生产植入物。
在第5,798,924号的美国专利中，公开了一种用于制造内用假体的方法，在该方法中，使用CT扫描来获得患者的现有骨骼结构的三维真实模型的数据块。在计算机中，从现有的或CT扫描产生的三维基准模型的数据块中减去所述真实模型。然后，根据差别，形成内用假体的计算机内模型。将真实模型和基准模型的数据块转换为CAD自由形式表面几何图形的数据。
前述方法或设备中没有一个能完全为外科医生提供一种产生患者专用的假体、手术器械、引导件和固定装置的方式，并且它们中也没有一个能有助于减少用于在诸如全膝、髋关节或踝关节置换手术的矫形过程中相对于患者身体定位切除引导件的固定装置的数量或复杂性。
发明内容
本发明提供了一种包括骨骼接合部的切除引导件定位器，所述骨骼接合部具有在形貌上与在手术过程中要切除的骨骼的表面轮廓互补的表面。在附接到所述接合部的壳体中限定有插口。切除引导件定位器的弹性壁限定所述插口的外周区域，并且设定所述弹性壁的尺寸和形状，以在切除引导件被压配合到插口中时存储能量。在手术中使用时，切除引导件与所述壁的一部分在操作上接合，以便在所述骨骼接合部的表面以可释放的方式锁定到骨骼的同时将所述引导件保持就位。
在本发明的另一实施方式中，提供了一种包括骨骼接合部的切除引导件定位器，所述骨骼接合部具有与在手术过程中要切除的骨骼的相应的分开的表面形貌互补的两个表面。壳体部被附接到所述骨骼接合部，并且包括由弹性环形壁限定的插口，设定所述弹性环形壁的尺寸和布置方式，以便通过压配合来接纳切除引导件，从而将所述切除引导件定位并且保持在所述插口内。这样，在所述两个表面以可释放的方式在骨骼上锁定就位的同时，所述切除引导件被保持在预定的优选位置。
在进一步的实施方式中，提供了一种包括基部的切除引导件定位器，设定所述基部的尺寸，以接合在手术过程中要切除的骨骼的一部分。所述基部具有在形貌上与骨骼的表面形貌互补的至少一个表面。附接到所述基部的壳体包括由弹性周向壁限定的插口，所述弹性周向壁被布置为在切除引导件被压配合到插口中以便可操作地接合所述壁时存储能量。这种布置能在所述骨骼接合部的在形貌上互补的表面被以可释放的方式锁定到骨骼的同时将引导件相对于骨骼保持在预定的位置。
还提供了一种用于形成并定位切除引导件的方法，在该方法中，产生在解剖学上准确的图像，该图像包括骨骼的表面形貌。将在解剖学上准确的图像转换为数字模型，并将切除引导件定位器的数字表示添加到所述数字模型，以便形成合成的数字模型。在基于所述合成的数字模型制造切除引导件定位器之前，将所述表面形貌互补地映射到所述切除引导件定位器的骨骼接合部上，从而所制造的切除引导件定位器被形成为包括位于骨骼接合部上的所述互补的表面形貌并形成为包括接收槽，设定该接收槽的尺寸，从而以压配合的方式接纳切除引导件。将所述切除引导件定位器应用到所述骨骼，使得所述互补的表面形貌将所述骨骼接合部以可释放的方式锁定到所述骨骼的对应的部分。
附图说明
本发明的这些以及其他特征和优势将在以下针对本发明的优选实施方式的详细描述中得到更充分的公开，或者将通过这样的详细描述而变得明显，这些详细描述应该连同附图一起考虑，在附图中，相同的附图标记表示相同的部件，并且此外在附图中：
图1是安装在根据本发明形成的并且被分别定位在股骨和胫骨的部分上的切除引导件定位器内的股骨切除引导件和胫骨切除引导件的立体图；
图2是人类膝关节的扫描图像的示意性图示；
图3是图2中示出的人类膝关节的扫描图像在转换成根据本发明的计算机模型后的示意性图示；
图4是根据本发明的类似于图3的示意性图示，示出了叠加在图3的计算机模型上的建议的切除线和局部坐标；
图5是类似于图4的示意性图示；
图6是类似于图4和图5的示意性图示，但示出了出现在图3的计算机模型中的根据本发明的股骨切除引导件定位器和胫骨切除引导件定位器；
图7是类似于图4、图5和图6的示意性图示，(以截面图)示出了根据本发明叠加在所述模型内的股骨假体和胫骨假体的数字表示；
图8是根据本发明形成的股骨切除引导件定位器的立体图；
图9是图8中示出的股骨切除引导件定位器的后视立体图；
图10是图9中示出的股骨切除引导件定位器的前侧的正视图；
图11是图9和图10中示出的股骨切除引导件定位器的底部的正视图；
图12是根据本发明形成的胫骨切除引导件定位器的立体图；
图13是图12中示出的胫骨切除引导件定位器的仰视立体图；
图14是图13中示出的胫骨切除引导件定位器的俯视图；
图15是图14中示出的胫骨切除引导件定位器的后视图；
图16是通常的胫骨切除引导件的立体图；
图17是图16中示出的胫骨切除引导件的前视图；
图18是图17中示出的胫骨切除引导件的侧视立体图；
图19是安装在被定位在股骨髁上的股骨切除引导件定位器内的股骨切除引导件的立体图；
图20是安装在被定位在胫骨的关节面上的胫骨切除引导件定位器内的胫骨切除引导件的立体图；
图21是安装在根据本发明形成的并且被分别定位在胫骨和距骨的部分上的切除引导件定位器内的胫骨切除引导件和距骨切除引导件的立体图；
图22是根据本发明形成的胫骨切除引导件定位器的立体图；
图23是胫骨切除引导件和根据本发明形成的胫骨切除引导件定位器的分解立体图；
图24是安装在根据本发明形成的并且被定位在胫骨的下部上的切除引导件定位器内的胫骨切除引导件的立体图；
图25是安装在根据本发明形成的并且被定位在胫骨的远侧部上的切除引导件定位器内的胫骨切除引导件的前视图；
图26是胫骨切除引导件和根据本发明形成的并且被定位在胫骨的下部上的胫骨切除引导件定位器的分解侧视图；
图27是在施加和使用胫骨切除引导件和根据本发明形成的胫骨切除引导件定位器之后切除的远侧胫骨的示意性图示；
图28是安装在根据本发明形成的并且被定位在距骨的部分上的距骨切除引导件定位器内的距骨切除引导件的立体图；
图29是安装在根据本发明形成的距骨切除引导件定位器内的距骨切除引导件的立体图；
图30是距骨切除引导件和根据本发明形成的距骨切除引导件定位器的分解立体图；
图31是根据本发明形成的并且被定位在踝关节的距骨上的距骨切除引导件定位器的立体图；
图32是安装在根据本发明形成的并且被定位在距骨的前部上的切除引导件定位器内的距骨切除引导件的前视图；
图33是距骨切除引导件和根据本发明形成的并且被定位在距骨的上部上的距骨切除引导件定位器的分解侧视图；以及
图34是在施加和使用距骨切除引导件和根据本发明形成的距骨切除引导件定位器之后切除的距骨的示意性图示。
具体实施方式
应结合附图来理解针对优选实施方式的描述，附图应被认为是本发明整个说明书的一部分。为了清楚和简洁的目的，附图未必是按比例绘制的，并且本发明的某些特征可能在比例上是以夸大的形式示出的，或者某些特征可能是以略带示意性的形式示出的。在说明书中，诸如“水平”、“垂直”、“上”、“下”、“顶部”和“底部”及其衍生词汇(例如，“水平地”、“向下地”、“向上地”等)的相对性的术语应被解释为表示所讨论的附图中所描述或示出的方向。这些相对性的术语只是为了描述的方便，并且通常并不意味着要求特定的方向。视情况而定，包括“向内地”相对于“向外地”、“纵向”相对于“横向”以及类似术语的术语应相对于彼此或相对于延长轴或旋转轴或旋转中心来解释。除非另有说明，关于附接、联接以及类似情形的术语，例如“连接的”和“互连的”，是指这样一种关系，即，结构直接或通过中间结构间接固定或附接到彼此，并且这些术语还指活动的或刚性的附接或关系。当仅示出单个机器时，术语“机器”也应包括能单独地或共同地执行一套(或多套)指令以实现本文所讨论的任何一种或多种方法的机器的任何集合。术语“可操作地连接”是指这样一种附接、联接或连接，这种附接、联接或连接允许相关结构借助于这种关系而按预期操作。在权利要求中，装置加功能的写法(如果使用的话)旨在覆盖由说明书或附图描述、暗示或由于说明书或附图而变得明显的用于执行所述功能的结构，这些结构不仅包括结构等同物而且还包括等同的结构。
本发明提供了订制的手术器械、引导件和固定装置，这些订制的手术器械、引导件和固定装置是以由计算机X射线断层造影扫描仪(CT)、磁共振成像机器(MRI)或类似医学成像技术确定的患者解剖结构为基础的。例如，CT或MRI扫描的图像1或一系列的图像可以取自患者的膝1或踝关节1a，包括从骨盆开始的肢体或足部的部分(图2和图3)。在全膝置换的情况下，然后将CT或MRI扫描的图像数据从例如DICOM图像格式转换成通常包括骨盆、股骨、膝盖骨、胫骨或足部的下肢的实体计算机模型3，以使用通常被体现为机算机软件的专用建模方法来确定移植物的对准、类型和大小。源自CT或MRI扫描的图像数据1的计算机生成的实体模型3通常将包括有关围绕已经成像的结构的表面轮廓(例如，已经成像的骨骼的表面形貌或筋膜的轮廓)的精准信息。将理解，表面形貌是指诸如凹部和突起或类似物的表面特征的位置、形状、大小和分布。
已经发现，在颁发给Swaelens等人并且以引用方式并入本文的第5,768,134号美国专利中公开的方法能将CT或MRI扫描的图像数据1适当转换成可由本发明使用的实体计算机模型3。在一些实施方式中，使用CT或MRI机器或其他数字图像捕获和处理单元(图2和图3)，形成下肢即，患者的盆骨、股骨、膝盖骨、胫骨和/或足部的图像。这种扫描产生了患病的膝或踝关节(包括股骨5和胫骨6的邻接部分)的扫描图像。首先在处理单元中处理图像数据1，之后，使用经处理的数字化图像数据产生模型。
根据本发明，执行数字化图像数据的交互式处理和准备，包括操纵和引入额外的外来数字信息8，例如，用于部件定位和对准10的预定义的基准位置9，从而对将要在手术期间切除的手术部位的调节进行设计并映射到计算机模型3上(图4和图5)。在进行数字化图像数据的交互式处理之后，可以返回到原始的CAD数据，以获得患者专用的手术器械、假体7a、7b(图7)引导件或固定装置的较高分辨率的数字表示，以便将所述数字表示添加到患者的数据图像模型。
例如，当本发明的系统被用于膝置换手术时，可将股骨切除引导件安装件20的数字表示添加到患者的图像数据模型(图1和图6)。在全膝置换的情况下，股骨切除引导件安装件20被形成为用于放置在患者的股骨的暴露的髁上，以确保精准地定位用于在手术期间引导和控制股骨5的骨骼切除的股骨切除引导件26。尽管股骨切除引导件26可采用多种形式和构造，但是将参照当前由申请人WrightMedicalTechnology，Inc提供的远侧切除引导件(WrightMedicalPartNo.K001-2659)来描述本发明。重要的是，股骨切除引导件安装件20能提供这种精准的定位功能，而不需要其他外部固定装置或使用沿着股骨轴线插入穿过髁间凹口并向上穿过股骨5的髓内杆。胫骨切除引导件安装件22的数字表示也可被添加到患者的图像数据模型(图6)。类似地，胫骨切除引导件安装件22被形成为用于放置在患者的胫骨6的暴露的上关节表面上，以确保精准地定位用于在手术期间引导和控制暴露的胫骨的上关节表面的骨骼切除的胫骨切除引导件28。
参照图8至图11，根据本发明的一个实施方式的股骨切除引导件安装件20由适合与立体平版印刷、选择性激光烧结或类似制造设备相关使用的类型的弹性聚合物材料形成。切除引导件安装件20包括一体式结构(unitaryblock)，该一体式结构包括双叉髁轭25和引导件接收器29。双叉轭25包括从基部33向外突出的一对间隔开的臂30、31。臂30具有下表面或骨骼接合表面36以及贯通孔38，并且臂31具有下表面或骨骼接合表面40以及贯通孔42。通过前述成像操作，骨骼接合表面36、40被配置为与患者自然骨骼的所选区域的解剖表面特征互补地匹配。对于图8至图11的股骨切除引导件安装件20的实施方式，所选骨骼区域包括患者股骨的髁。
引导件接收器29包括一对翼44、46，这对翼沿相反的方向从基部33向外突出，并且与臂30、31成间隔开的关系。每个翼44、46均包括向上突出以支撑引导件壳体49的塔架(pylon)48，使得在基部33与引导件壳体49之间限定出细长槽52。槽52的大小和形状允许骨骼切除通常所用类型的典型手术锯从切除引导件26中的具有对应的位置和大小的槽穿过，而不接触或只是偶然接触切除引导件定位器20。具有与股骨切除引导件26的外轮廓互补的形状的环形壁55以与后壁61成大致垂直的关系向外突出，并因此限定凹部58。在一些优选的实施方式中，设定凹部58的尺寸以便以“压配合”的方式接纳股骨切除引导件26。应理解，压配合是指环形壁55具有足够的弹性以在股骨切除引导件26被推入凹部58内时弹性地偏转或压缩，以便存储弹性能。当然，还应理解，对于压配合实施方式而言，股骨切除引导件26将具有与凹部58的外周形状互补但尺寸稍大的外周形状。而且，股骨切除引导件26可仅通过与环形壁55的摩擦接合而被保持在凹部58中，或在次优选的实施方式中，切除引导件26可简单地滑动到凹部58中，而不会操作性地接触或只是偶然地接合环形壁55。在后壁61中限定有成相互间隔开的关系的第一贯通孔62、64，并且第二贯通孔67、69与每个第一贯通孔62、64相关联。在图8至图11所示的实施方式中，第一贯通孔62、64是大的方形或长方形开口，即，是这样一种构造：其易于制造，能减少材料的使用，并且提供足够的空间用于驱动销、线、螺钉或其他适当的紧固件穿过设置在股骨切除引导件26上的多个相邻的孔。在基部33的外表面中限定有凹槽70，并且该凹槽70相对于凹部58居中地定位，以匹配切除引导件26。
参照图12至图18，根据本发明的一个实施方式的胫骨切除引导件安装件22由适合与立体平版印刷、选择性激光烧结或类似制造设备相关使用的类型的弹性聚合物材料形成，例如，由适合与选择性激光烧结相关使用的聚酰胺粉末快速原型材料(polyamidepowderrepaidprototypematerial)形成。切除引导件安装件22包括一体式结构，该一体式结构包括双叉轭75和引导件接收器79。双叉轭75包括从基部83向外突出的一对间隔开的臂80、81。臂80具有下表面86，并且臂81具有下表面90。
引导件接收器79包括一对翼84、86，这对翼沿相反的方向从基部83向外突出，并且与臂80、81成间隔开的关系。每个翼84、86均包括向上突出以支撑引导件壳体89的塔架88，使得在基部83与引导件壳体89之间限定出细长槽94。槽94的大小和形状允许骨骼切除通常所用类型的典型手术锯穿过切除引导件28中的具有对应的位置和大小的槽，而不接触或只是偶然接触切除引导件定位器22。具有与胫骨切除引导件28的外轮廓互补的形状的环形壁95以与后壁101成大致垂直的关系向外突出，并因此限定凹部108。设定凹部108的尺寸，从而以压配合方式接纳胫骨切除引导件28。在后壁101中限定有成相互间隔开的关系的第一贯通孔112、114，并且第二贯通孔117、119与每个第一贯通孔112、114相关联。
回到之前公开的数字图像模型3，并且考虑添加到患者的股骨图像数据的切除引导件安装件20的广义数字模型(generalizeddigitalmodel)，患者股骨的解剖表面特征，例如，髁表面形貌，可被互补地映射到臂30的下表面36和臂31的下表面40中的每一个上。应理解，数字图像的互补映射导致骨骼表面上的局部突起(例如，髁、皮层表面或关节面)变成下表面36或下表面40上的局部凹陷，而骨骼表面上的局部凹陷变成下表面36或下表面40上的局部突起。这样，下表面36和下表面40均通过与患者股骨的所选区域的解剖表面特征互补的大致镜像图像重新限定。作为这种互补的骨骼表面映射的结果，切除引导件安装件20可释放地“锁定”到患者自然股骨的对应部分的互补形貌上，例如，锁定到髁表面，而不需要其他外部或内部引导固定装置。换句话说，骨骼表面凹凸与在股骨切除引导件安装件20的保形的骨骼接合表面中形成的对应的凹陷的配合确保了在股骨切除引导件安装件20和髁表面之间产生很少的相对运动或不产生相对运动，例如，侧向滑移。关于患者专用的胫骨切除引导件安装件22的设计，实施大致相同的映射。
形成患者股骨与切除引导件安装件20之间的虚拟对准结果的可视表示，并将该可视表示发送给外科医生以在制造之前获得对该结果的认可(图1、图19和图20)。在收到外科医生的认可之后，制造切除引导件安装件20，并且在适当的情况下，制造切除引导件安装件22，并将它们返回给外科医生，以在手术中使用。
在全膝置换期间，本发明是以下述方式来使用的。外科医生首先将切除引导件安装件20在股骨5上进行定向，直到切除引导件安装件20的下表面36、40牢固地与股骨5的暴露表面4的形貌相互接合，以便与股骨5的暴露表面4的形貌可释放地“互锁”。在切除引导件安装件20被锁定到患者股骨的情况下，外科医生将适当构造的远侧切除引导件26(例如，WrightMedicalTechnology，Inc.PartNo.K001-2659)压配合到切除引导件安装件20的凹部58中。如在图19至图20中示出的，这导致切除引导件安装件20，且尤其是切除引导件安装件20的引导件接收器部分29，被夹在切除引导件26和患者骨骼之间。将销钉打入切除引导件26的贯通孔内，但有利地，这些销钉不与切除引导件安装件20的限定有贯通孔62、64或67、69的部分接触。这些贯通孔通常在切除引导件安装件20的最近侧。在切除引导件安装件20被牢固地保持到位的情况下，将钻头推入贯通孔38和42、限定在后壁61中的贯通孔62、64和/或推入第二贯通孔67、69内。通常优选的是，钻头伸出贯通孔38和42大约15mm，而进入股骨，以便在远侧切除之后呈现出钻孔。在较大的远侧切除的情况下，可能需要增加孔深度，以矫正屈曲挛缩。为了额外的稳定性，可以在贯通孔38和42中留下固定销钉(未示出)，但必须在切除之前移除固定销钉。在切除引导件安装件20因此相对于所选骨骼区域而被准确地定位并且切除引导件26-引导件安装件20构造被适当地固定到患者骨骼的情况下，外科医生使用常规的手术刀片和切除引导件26的切除槽来切除患者骨骼。
当本发明的系统用于踝关节置换手术时，以与股骨切除引导件安装件20和胫骨切除引导件安装件22几乎相同的方式，形成胫骨切除引导件安装件120和距骨切除引导件安装件122，并且将胫骨切除引导件安装件120和距骨切除引导件安装件122分别安装到患者的下胫骨123和上距骨124。更具体地，根据本发明的一个实施方式的胫骨切除引导件安装件120由适合与立体平版印刷或类似制造设备相关使用的类型的弹性聚合物材料形成(图22)。切除引导件安装件120包括一体式本体，该一体式本体包括从基部127向上突出的十字形胫骨轭125，基部127还限定有引导件接收凹部129。十字形轭125包括从中心柱133向外突出的一对间隔开的臂130、131。臂130、131以及中心柱133均具有与患者下胫骨的对应部分的轮廓互补的保形的骨骼接合表面134(图26)。通过前述成像操作，臂130、131以及中心柱133的保形的骨骼接合表面134被配置为与患者自然骨骼的所选区域的解剖表面特征互补地匹配。对于胫骨切除引导件安装件120，所选骨骼区域包括患者胫骨的下表面。
邻近臂130、131的交叉处，导向块(pilotblock)135从中心柱133向外突出。在基部127上定位有与导向块135成间隔关系的支撑块136。引导件接收凹部129由在基部127上从中心柱133的两侧以相反方向向外延伸的一对翼144、146限定，并且支撑块136被定位在所述一对翼144、146之间。每个翼144、146均包括从基部127向外突出以便为胫骨切除引导件150提供横向支撑的塔架148(图21和图22)。在导向块135之下，但在支撑块136之上，在基部127的中央部分中横向地限定有一细长槽152。每个翼144、146也限定了相对于中央柱133成角度地定向的槽153。槽152和153的大小和形状允许骨骼切除通常所用类型的典型手术锯151(图26)穿过切除引导件150中的具有对应的位置和大小的槽，而不接触或只是偶然接触切除引导件定位器120。
参照图21和图23，胫骨切除引导件150包括从桥接梁157的端部以发散的角度关系向下并向外突出的一对臂155。这样，胫骨切除引导件150的形状与由导向块135、支撑块136和塔架148的面向内的表面限定的引导件接收凹部129的形状互补。桥接梁157限定有细长槽156，并且臂155各自限定有槽158，当被组装到切除引导件安装件120时，这些槽分别与基部127中的细长槽152和槽153以相同的边界对准。导向块135、支撑块136和塔架148的面向内的表面149一起限定引导件接收凹部129，这些表面的形状与胫骨切除引导件150的外轮廓互补。在一些优选的实施方式中，设定引导件接收凹部129的尺寸，从而以“压配合”的方式接纳胫骨切除引导件150。应理解，压配合是指导向块135、支撑块136和塔架148的面向内的表面149具有足够的弹性以在胫骨切除引导件150被推入引导件接收凹部129时弹性地偏转或压缩，以便存储弹性能。当然，还应理解，对于压配合实施方式，胫骨切除引导件150将具有与引导件接收凹部129的外周形状互补但尺寸稍大的外周形状。而且，胫骨切除引导件150可仅通过与导向块135、支撑块136和塔架148的面向内的表面的摩擦接合来保持在引导件接收凹部129中，或在次优选的实施方式中，胫骨切除引导件150可简单地滑动到引导件接收凹部129中，而不会操作性地接触或只是偶然地接合导向块135、支撑块136和塔架148的面向内的表面。
参照图21和图28至图33，根据本发明的一个实施方式的距骨切除引导件安装件122由适合与立体平版印刷、选择性激光烧结或类似制造设备相关使用的类型的弹性聚合物材料形成，例如，由适合与选择性激光烧结使用的聚酰胺粉末快速原型材料形成。距骨切除引导件安装件122还包括与患者上距骨124的对应部分的轮廓互补的保形的骨骼接合表面137(图21、图28和图31至图34)。通过前述成像操作，距骨切除引导件安装件122的保形的骨骼接合表面137被配置为与患者自然骨骼的所选区域的解剖表面特征互补地匹配。对于距骨切除引导件安装件122，所选骨骼区域包括患者距骨的外部上表面。
距骨切除引导件安装件122包括限定了中央引导件接收凹部179和一对贯通孔180的一体式结构(图30)。引导件接收凹部179由从基部183以相反的方向向外突出的一对翼184、186的面向内的表面181限定。每个翼184、186均包括向上突出以支撑引导件壳体189的塔架188，使得在基部183之内并且在引导件壳体189之下限定出细长槽194(图31和图33)。槽194的大小和形状允许骨骼切除通常所用类型的典型手术锯151穿过距骨切除引导件200中的具有对应的位置和大小的槽196，而不接触或只是偶然接触距骨切除引导件定位器122。具有与距骨切除引导件200的外轮廓互补的形状的环形壁195以与后壁成大致垂直的关系向外突出，以便进一步限定引导件接收凹部179。
参照图28、图29和图30，距骨切除引导件200包括一对相对的平行板202、203，这对平行板在之间限定有细长槽196，并且在它们的端部通过翼206彼此结合。这样，距骨切除引导件200的形状与由翼184和186、基部183以及塔架188的面向内的表面181限定的引导件接收凹部179的形状互补。设定引导件接收器凹部179的尺寸，从而以压配合的方式接纳距骨切除引导件200。当然，还应理解，对于压配合实施方式，距骨切除引导件200将具有与引导件接收凹部179的外周形状互补但尺寸稍大的外周形状。而且，距骨切除引导件200可仅通过与翼184和186、基部183以及塔架188的面向内的表面181的摩擦接合而被保持在引导件接收凹部179中，或在次优选的实施方式中，距骨切除引导件200可简单地滑动到引导件接收凹部179中，而不会操作性地接触或只是偶然地接合翼184和186、基部183以及塔架188的面向内的表面181。
与之前所公开的数字图像模型3一样，并且考虑添加到患者的下胫骨图像数据的胫骨切除引导件安装件120的广义数据模型，患者下胫骨的解剖表面特征，例如，表面形貌，可被互补地映射到臂130、131和中央柱133的各保形的骨骼接合表面134(即，将会接合骨骼的独特表面形貌的表面)。应理解，数字图像的互补映射导致骨骼表面上的局部突起变成臂130、131和中央柱133的保形的骨骼接合表面134上的局部凹陷，而骨骼表面上的局部凹陷变成臂130、131和中央柱133的保形的骨骼接合表面134上的局部突起。这样，臂130、131和中央柱133的保形的骨骼接合表面134均通过与患者下胫骨的所选区域的解剖表面特征互补的大致镜像的图像重新限定。作为这种互补的骨骼表面映射的结果，胫骨切除引导件安装件120可释放地“锁定”到患者自然胫骨的对应部分的互补形貌上，而不需要其他外部或内部引导固定装置。换句话说，骨骼表面凹凸与在胫骨切除引导件安装件120的保形的骨骼接合表面134中形成的对应的凹陷的配合确保了在胫骨切除引导件安装件120和胫骨表面之间产生很少的相对运动或不产生相对运动，例如，侧向滑移。关于患者专用的距骨切除引导件安装件122的设计，实施大致相同的映射。
形成患者下胫骨与切除引导件安装件120之间以及患者上距骨与切除引导件安装件122之间的虚拟对准结果的可视表示，并将该可视表示发送给外科医生以在制造之前获得对该结果的认可。在收到外科医生的认可之后，制造切除引导件安装件120和切除引导件安装件122，并将它们返回给外科医生，以在手术中使用。
在全踝关节置换期间，本发明是以下述方式来使用的。外科医生首先将切除引导件安装件120在下胫骨123上进行定向，直到切除引导件安装件120的臂130、131和中央柱133的保形的骨骼接合表面134牢固地与下胫骨123的暴露表面的形貌相互接合，以便与下胫骨123的暴露表面的形貌可释放地“互锁”。在切除引导件安装件120被锁定到患者下胫骨的情况下，外科医生将适当构造的远侧切除引导件150压配合到切除引导件安装件120的引导件接收凹部129中。这导致切除引导件安装件120被夹在切除引导件150和患者骨骼之间(图21、图24和图25)。在切除引导件安装件120相对于所选骨骼区域而被准确地定位并且切除引导件150-引导件安装件120构造借助于骨骼表面凹凸与在保形的骨骼接合表面134中形成的对应的凹陷配合而被适当地固定到患者骨骼的情况下，外科医生使用常规的手术刀片151和切除引导件150的切除槽152和153来切除患者骨骼(图27)。
以类似的方式，当距骨切除引导件安装件122被添加到患者距骨图像数据时，患者上距骨的解剖表面特征，例如，表面形貌，可被互补地映射到保形的骨骼接合表面137上。应再次理解的是，数字图像的互补映射导致骨骼表面上的局部突起变成保形的骨骼接合表面137上的局部凹陷，而骨骼表面上的局部凹陷变成保形的骨骼接合表面137上的局部突起。这样，保形的骨骼接合表面137通过与患者下胫骨的所选区域的解剖表面特征互补的大致镜像图像重新限定。作为这种互补的骨骼表面映射的结果，距骨切除引导件安装件122可释放地“锁定”到患者自然距骨的对应部分的互补形貌上，而不需要其他外部或内部引导固定装置。
为了继续全踝关节置换，外科医生首先将切除引导件安装件122在上距骨124上进行定向，直到切除引导件安装件122的保形的骨骼接合表面137“锁定”到上距骨124的暴露表面的形貌。在切除引导件安装件122被锁定到患者上距骨的情况下，外科医生将适当构造的远侧切除引导件200压配合到切除引导件安装件122的引导件接收凹部179中。这导致切除引导件安装件122被夹在切除引导件200和患者骨骼之间(图21、图28、图32和图33)。在切除引导件安装件122相对于所选骨骼区域而被准确地定位并且切除引导件200-引导件安装件122构造借助于骨骼表面凹凸与在保形的骨骼接合表面137中形成的对应的凹陷配合而被适当地固定到患者骨骼的情况下，外科医生使用常规的手术刀片151和切除引导件200的切除槽196来切除患者骨骼(图34)。
应理解，本发明绝不仅限于此处所公开和附图中所示出的特定的结构，而是包括在所附权利要求的范围内的任何变型例或等同物。

Claims (24)

1.一种手术器械，该手术器械包括：
切除引导件，该切除引导件限定槽和第一对贯通孔；以及
切除引导件定位器，该切除引导件定位器包括：骨骼接合部，该骨骼接合部具有与要切除的骨骼的表面形貌互补的表面；壳体，该壳体附接到所述骨骼接合部；以及插口，该插口限定在所述壳体中并且该插口的尺寸被设定为接纳所述切除引导件以便在所述骨骼接合部的所述表面被布置为与所述骨骼接触的同时将所述切除引导件保持就位，所述切除引导件定位器包括限定在基部和所述壳体之间的细长槽，以相互间隔开的关系被限定在所述切除引导件定位器的后壁中的第二对贯通孔，
其中，由所述切除引导件定位器限定的所述细长槽和所述第二对贯通孔相对于所述切除引导件定位器的所述插口被定位，使得当所述切除引导件被接纳在所述插口中时，由所述切除引导件定位器限定的所述细长槽与由所述切除引导件限定的所述槽对准并且由所述切除引导件定位器限定的所述第二对贯通孔与由所述切除引导件限定的所述第一对贯通孔对准，
其中，由所述切除引导件限定的所述槽和由所述切除引导件定位器限定的所述细长槽的尺寸被设定为并且被构造为，当所述骨骼接合部与骨骼接触并且所述切除引导件被接纳在所述插口中时，所述槽和所述细长槽将锯片接纳在其中，并且
其中，由所述切除引导件限定的所述第一对贯通孔和由所述切除引导件定位器限定的所述第二对贯通孔的尺寸被设定为并且被构造为将销或线接纳在其中，用于将所述切除引导件和所述切除引导件定位器固定到所述骨骼。
2.如权利要求1所述的手术器械，其中，所述骨骼接合部的所述表面包括这样一种表面形貌，在这种表面形貌中，一个或更多个局部突起的位置、形状和尺寸与限定了所述骨骼的所述表面形貌的一部分的对应的一个或更多个局部凹陷的位置、形状和尺寸互补。
3.如权利要求1所述的手术器械，其中，所述骨骼接合部的所述表面包括这样一种表面形貌，在这种表面形貌中，一个或更多个局部凹陷的位置、形状和尺寸与限定了所述骨骼的所述表面形貌的一部分的对应的一个或更多个局部突起的位置、形状和尺寸互补。
4.如权利要求2或3所述的手术器械，其中，所述骨骼的所述表面包括髁表面。
5.如权利要求2或3所述的手术器械，其中，所述骨骼的所述表面包括关节面。
6.如权利要求2或3所述的手术器械，其中，所述骨骼的所述表面包括皮层表面。
7.如权利要求1所述的手术器械，其中，所述骨骼接合部的所述表面包括与所述骨骼的选定区域的解剖表面特征互补的大致镜像的图像。
8.如权利要求2或3所述的手术器械，其中，所述一个或更多个局部突起以及对应的所述一个或更多个局部凹陷牢固地彼此接合，以便使所述切除引导件的所述骨骼接合部的所述表面与所述骨骼的所述表面以可释放的方式互锁。
9.如权利要求3所述的手术器械，其中，所述骨骼表面的突起中的至少一个突起与在所述切除引导件定位器的骨骼接合表面中限定的对应的互补的凹陷的配合阻止所述突起与所述凹陷之间的相对运动。
10.如权利要求2所述的手术器械，其中，所述骨骼表面的凹陷中的至少一个凹陷与在所述切除引导件定位器的骨骼接合表面中限定的对应的互补的突起的配合阻止所述凹陷与所述突起之间的相对运动。
11.一种手术器械，该手术器械包括：
切除引导件，该切除引导件限定槽和第一对贯通孔；以及
切除引导件定位器，该切除引导件定位器包括：骨骼接合部，该骨骼接合部具有与要切除的骨骼的表面形貌互补的表面；壳体，该壳体附接到所述骨骼接合部；以及插口，该插口由弹性壁限定在所述壳体中，所述弹性壁被布置成在所述切除引导件被压配合到所述插口中并且与所述壁的一部分在操作上接合时存储能量，以便在所述骨骼接合部的所述表面被布置为与所述骨骼接触的同时将所述切除引导件保持就位，所述切除引导件定位器包括限定在基部和所述壳体之间的细长槽，以相互间隔开的关系被限定在所述切除引导件定位器的后壁中的第二对贯通孔，
其中，由所述切除引导件定位器限定的所述细长槽和所述第二对贯通孔相对于所述切除引导件定位器的所述插口被定位，使得当所述切除引导件被接纳在所述插口中时，由所述切除引导件定位器限定的所述细长槽与由所述切除引导件限定的所述槽对准并且由所述切除引导件定位器限定的所述第二对贯通孔与由所述切除引导件限定的所述第一对贯通孔对准。
12.如权利要求11所述的手术器械，其中，所述骨骼接合部的所述表面包括这样一种表面形貌，在这种表面形貌中，一个或更多个局部突起的位置、形状和尺寸与限定了所述骨骼的所述表面形貌的一部分的对应的一个或更多个局部凹陷的位置、形状和尺寸互补；并且其中，所述骨骼接合部的所述表面还包括这样一种表面形貌，在这种表面形貌中，一个或更多个局部凹陷的位置、形状和尺寸与限定了所述骨骼的所述表面形貌的一部分的对应的一个或更多个局部突起的位置、形状和尺寸互补。
13.如权利要求11所述的手术器械，其中，所述骨骼的所述表面包括髁表面、关节面以及皮层表面中的至少一种。
14.如权利要求11所述的手术器械，其中，所述骨骼接合部的所述表面包括与所述骨骼的选定区域的解剖表面特征互补的大致镜像的图像。
15.如权利要求12所述的手术器械，其中，所述一个或更多个局部突起以及对应的所述一个或更多个局部凹陷牢固地彼此接合，以便使所述切除引导件的所述骨骼接合部的所述表面与所述骨骼的所述表面以可释放的方式互锁。
16.如权利要求12所述的手术器械，其中，所述骨骼表面的突起中的至少一个突起与在所述切除引导件定位器的骨骼接合表面中限定的对应的互补的凹陷的配合阻止所述突起与所述凹陷之间的相对运动。
17.如权利要求12所述的手术器械，其中，所述骨骼表面的凹陷中的至少一个凹陷与在所述切除引导件定位器的骨骼接合表面中限定的对应的互补的突起的配合阻止所述凹陷与所述突起之间的相对运动。
18.一种手术器械，该手术器械包括：
切除引导件，该切除引导件限定切除槽和第一对贯通孔；以及
切除引导件定位器，该切除引导件定位器包括：骨骼接合部，该骨骼接合部具有与要切除的骨骼的表面形貌互补的表面；壳体，该壳体附接到所述骨骼接合部；以及插口，该插口限定在所述壳体中并且该插口的尺寸被设定为以通过压配合的方式接纳所述切除引导件，以便在所述骨骼接合部的所述表面被布置为与所述骨骼表面成牢固的互锁关系的同时将所述切除槽相对于所述骨骼接合部保持在大致固定的定向，所述切除引导件定位器包括限定在基部和所述壳体之间的细长槽，以相互间隔开的关系被限定在所述切除引导件定位器的后壁中的第二对贯通孔，
其中，由所述切除引导件定位器限定的所述细长槽和所述第二对贯通孔相对于所述切除引导件定位器的所述插口被定位，使得当所述切除引导件被接纳在所述插口中时，由所述切除引导件定位器限定的所述细长槽与由所述切除引导件限定的所述切除槽对准并且由所述切除引导件定位器限定的所述第二对贯通孔与由所述切除引导件限定的所述第一对贯通孔对准。
19.如权利要求18所述的手术器械，其中，所述骨骼接合部的所述表面包括这样一种表面形貌，在这种表面形貌中，一个或更多个局部突起的位置、形状和尺寸与限定了所述骨骼的所述表面形貌的一部分的对应的一个或更多个局部凹陷的位置、形状和尺寸互补；并且其中，所述骨骼接合部的所述表面还包括这样一种表面形貌，在这种表面形貌中，一个或更多个局部凹陷的位置、形状和尺寸与限定了所述骨骼的所述表面形貌的一部分的对应的一个或更多个局部突起的位置、形状和尺寸互补。
20.如权利要求18所述的手术器械，其中，所述骨骼的所述表面包括髁表面、关节面以及皮层表面中的至少一种。
21.如权利要求18所述的手术器械，其中，所述骨骼接合部的所述表面包括与所述骨骼的选定区域的解剖表面特征互补的大致镜像的图像。
22.如权利要求19所述的手术器械，其中，所述一个或更多个局部突起以及对应的所述一个或更多个局部凹陷牢固地彼此接合，以便使所述切除引导件的所述骨骼接合部的所述表面与所述骨骼的所述表面以可释放的方式互锁。
23.如权利要求19所述的手术器械，其中，所述骨骼表面的突起中的至少一个突起与在所述切除引导件定位器的骨骼接合表面中限定的对应的互补的凹陷的配合阻止所述突起与所述凹陷之间的相对运动。
24.如权利要求19所述的手术器械，其中，所述骨骼表面的凹陷中的至少一个凹陷与在所述切除引导件定位器的骨骼接合表面中限定的对应的互补的突起的配合阻止所述凹陷与所述突起之间的相对运动。
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