CN113907878A - 用于导航型矫形手术的器械 - Google Patents

用于导航型矫形手术的器械 Download PDF

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CN113907878A
CN113907878A CN202110781726.3A CN202110781726A CN113907878A CN 113907878 A CN113907878 A CN 113907878A CN 202110781726 A CN202110781726 A CN 202110781726A CN 113907878 A CN113907878 A CN 113907878A
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tracking
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H·卡梅伦
O·沙皮伊
S·科斯切夫斯基
B·布罗特
P·埃克特
S·奇基尼
N·R·克劳福德
J·扎帕科斯塔
D·迈克
D·斯通波
T·布莱克韦尔
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Globus Medical Inc
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Abstract

用于计算机辅助导航和/或机器人辅助手术的装置、系统和方法。能够由外科医生使用手术机器人系统导航的可导航仪器允许对器械或其它手术装置进行导航移动。例如，器械可适用于涉及导航和/或机器人全膝关节成形术的过程。

Description

用于导航型矫形手术的器械
技术领域
本公开涉及医疗装置和系统，更具体地，涉及在手术过程中使用的导航型手术器械。
背景技术
存在许多需要切骨术的外科手术介入，即沿着目标平面切割如骨骼等解剖结构。全膝关节成形术(TKA)可包括切割股骨骨骺和胫骨骨骺以去除受损的骨骼和软骨并允许安装膝关节假体。
目前在TKA手术中，患者满意度可能只有大约80％。这与一些其它类型的矫形手术相比是低的，例如对于髋关节成形术，其患者满意度通常为约95％。尽管在新植入物设计、定制切割模板解决方案、定制植入物等方面进行了创新，但这些满意度几十年来基本保持不变。这表明，TKA和其它矫形手术可能存在一些先前的医疗程序和相关创新尚未解决的问题。
包括导航和/或机器人手术系统的计算机辅助手术(CAS)可以利用位置识别系统，可在3维(3D)中确定特定对象的位置和跟踪它。在导航和/或机器人辅助手术中，例如当医生和/或机器人定位和移动器械时，需要高度精确地跟踪某些对象，如手术器械。还需要提供用于导航型和/或机器人辅助手术的改进仪器。
发明内容
为了满足这种和其他需要，并且鉴于其目的，本申请提供了用于执行诸如全膝关节成形术(TKA)之类的矫形手术的装置、系统、器械和方法。可以提供一种外科机器人系统和/或导航系统，其导航一个或多个器械和/或帮助用户进行一个或多个手术。可导航仪器(包括能够被导航的器械)和导航软件允许对器械或其它手术装置进行导航。所述系统允许在开放式或微创(MIS)程序中定位解剖结构，并且在整个手术过程中导航手术器械和其他装置。
根据一个实施例，一种用于在手术期间进行计算机辅助导航的系统包括机器人导航系统、第一和第二动态参考基准件以及可导航的触针。机器人导航系统可以包括计算机、显示器和被配置为检测一个或多个跟踪标记的相机。第一动态参考基准件可以包括具有第一多个跟踪标记的第一参考阵列，并且第一动态参考基准件可以被配置为附接到并跟踪第一骨骼。第二动态参考基准件可以包括具有第二多个跟踪标记的第二参考阵列，并且第二动态参考基准件可以被配置为附接到并跟踪第二骨骼。可导航触针可以包括具有第三多个跟踪标记的第三参考阵列和通用快速连接附接尖端，其被配置为将触针快速附接到一个或多个器械并且将位置返回到机器人导航系统。当在全膝关节成形术中使用时，第一骨骼可以是股骨，第二骨骼可以是胫骨，反之亦然。股骨和胫骨在手术过程中可能处于屈曲或伸展的位置。
例如，器械可以是胫骨后壁钩或平面检查器。胫骨后壁钩可包括套环和钩。套环可以包括被配置为接收通用尖端的纵向开口，并且钩可以被配置为在全膝关节成形术期间定位胫骨壁。平面检查器可以包括套环和脚部。套环可以包括被配置为接收通用尖端的纵向开口，并且脚部可以包括具有平坦底面的U形板，其被配置为放置在切除平面上以返回成角和/或切割深度到机器人导航系统。器械可以相对于触针的纵轴自由旋转，从而允许第三参考阵列的快速重新定向，例如，以利于相机的视线。
根据另一个实施例，一种用于在手术期间进行计算机辅助导航的系统包括机器人导航系统、第一和第二动态参考基准件以及一个或多个监视标记。例如，第一监视标记可以被配置为附接到第一骨骼(股骨或胫骨中的一个)，并且第二监视标记可以被配置为附接到第二骨骼(股骨或胫骨的另一个)。监视标记可以包括主体，该主体包括终止于远侧尖端的紧固件(例如，骨针)和在监视标记上面的单个跟踪标记。监视标记可以包括集成到监视标记的主体中的验证凹痕(divot)。验证凹痕可以被配置为通过将单独器械(例如，触针)的尖端放入监视标记的验证凹痕来验证系统的导航完整性。
根据另一个实施例，一种用于在手术期间进行计算机辅助导航的系统包括机器人导航系统、第一和第二动态参考基准件以及一个或多个虚拟界标。例如，第一虚拟界标可以被配置为附接到第一骨骼并且第二虚拟界标可以被配置为附接到第二骨骼。例如，虚拟界标可以包括具有验证凹痕的皮质骨螺钉。虚拟界标可以被配置为通过将单独器械(例如，触针)的尖端放入监视标记的虚拟界标来验证系统的导航完整性。
根据又一实施例，一种用于在手术过程中进行计算机辅助导航的系统包括机器人导航系统和一个或多个配置成附接到并跟踪骨骼的动态参考基准件。动态参考基准件可以包括单个监视标记。由系统存储动态参考基准件的参考阵列与监视标记之间的距离。如果无意中移动了动态参考基准件和/或监视标记，则系统识别距离和/或移动的变化，从而将用户改变为中断。
根据又一个实施例，一种用于在手术期间进行计算机辅助导航的系统包括机器人导航系统、第一和第二动态参考基准件以及可导航平面检查器。平面检查器可包括具有参考阵列的主体，参考阵列包括多个跟踪标记、从主体延伸的轴和在轴的远端处的脚部。在膝关节手术期间使用时，平面检查器可以靠着切除物放置，以确保切除物的角度和/或位置正确。
根据又一实施例，一种用于在手术期间进行计算机辅助导航的系统包括机器人导航系统、第一和第二动态参考基准件、以及被配置用于界标定位和/或点获取的可导航触针。当触针在界标或感兴趣点上时，触针可以旋转一阈值旋转(例如，至少30°)。阈值旋转可由机器人导航系统捕获，从而由机器人导航系统捕获感兴趣的界标或点。在另一个实施例中，与触针的参考阵列相关的一个跟踪标记可以相对于其他跟踪标记物理地移动。当触针在界标或感兴趣点上时，机器人导航系统检测一个跟踪标记相对于另一个跟踪标记的移动并捕捉该界标或感兴趣点。
根据又一实施例，一种用于在手术期间进行计算机辅助导航的系统包括机器人导航系统、第一和第二动态参考基准件、以及张力器(tensor)，该张力器包括主体，该主体具有一对独立的上牵引桨板、下牵引桨板，连接到旋钮的轴，该旋钮被配置为相对于下牵引桨板移动上牵引桨板，以及围绕主体和旋钮之间的轴定位的弹簧。张力器可以被配置为在胫骨和股骨之间提供牵引力。例如，牵引旋钮的旋转可以将上牵引桨板向外平移并远离下牵引桨板，从而在上牵引桨板和下牵引桨板之间提供间隙。张力器可以包括定位在张力器的主体上的可枢转韧带平衡指示器。第一上牵引桨板可以通过第一杆连接到韧带平衡指示器的第一端，并且第二上牵引桨板可以通过第二杆连接到韧带平衡指示器的相对端。当牵引时，例如，在膝盖手术期间，张力器被配置为对下牵引桨板施加牵引力F牵引，对第一上牵引桨板施加力FLCL(外侧副韧带)，以及对抗第二上牵引桨板施加力FMCL(内侧副韧带)。当韧带处于FLCL＝FMCL的平衡状态时，韧带平衡指示器指示平衡，例如，通过在水平位置显示指标器。当韧带处于FLCL＜FMCL或FLCL＞FMCL的不平衡状态时，韧带平衡指示器指示不平衡，例如，通过在倾斜、斜放、歪斜位置显示指标器。指示器还可指示每个相应力的不平衡量或不平衡程度。
根据又一实施例，一种用于手术期间计算机辅助导航的系统包括机器人导航系统和一个或多个模块化动态参考基准件。模块化动态参考基准件可包括具有多个跟踪标记的参考阵列、集成的桥和销引导件以及一个或多个紧固件。多个跟踪标记中的每一个可以定位在被配置为防止导航丢失的保护罩内。桥可包括与第一销引导件对齐的第一开口和与第二销引导件对齐的第二开口。第一和第二紧固件可通过桥和销引导件接收以将动态参考基准件固定到骨骼。参考阵列可以包括具有横撑的矩形框架，以及放置在每个相应罩内在矩形框架的每个角处的跟踪标记。参考阵列可配置为例如绕两个轴线旋转。该阵列可以能够绕桥的纵轴线和/或与桥垂直的轴线旋转。在沿轴线的一个或两个调整后，参考阵列可被一个或多个锁定螺钉锁定到位。如果需要，可以使用延长臂以增加参考阵列的定位选项。桥可以临时连接到可拆卸的手柄上进行安装。动态参考基准件的模块化组件可以减少整个手术过程中使用的器械数量。
根据又一实施例，一种安装模块化动态参考基准件的方法可以包括以下以任何合适的顺序的一个或多个：(1)在患者体内形成切口；(2)将手柄连接到集成的桥和销引导件上；(3)将桥插入切口，直至桥接触皮质骨；(4)驱动一个或多个骨销穿过桥和销引导件；(5)将桥锁定在销上，例如使用锁定螺钉；(6)从桥上取下手柄；(7)将参考阵列附接到桥上；(8)可选地，在参考阵列和桥之间附接延伸部，以利于参考阵列的更多定位选择；(9)调整参考阵列的方向，例如沿一个或两个轴线；和(10)通过一个或多个锁定螺钉锁定参考阵列相对于桥的最终位置。
还提供了套件，其包括可导航的器械和不同类型和尺寸的组件、植入物、紧固件或锚固件、k线、插入工具和其他用于执行程序的组件。
附图说明
当结合附图考虑时，通过参考以下详细描述将更容易理解本发明及其伴随的优点和特征的更完整的理解，其中：
图1示出了股骨和胫骨，其中根据一个实施例，动态参考基准件附接到每个骨骼，以及具有通用参考元件的触针；
图2图示了根据一个实施例的手术机器人和/或导航系统；
图3图示了医疗操作，其中手术机器人和摄像系统位于患者周围；
图4A-4C示出了带有通用参考元件的触针、附接到触针的平面检查器械和附接到触针的胫骨后壁钩的实施例；
图5A-5B分别显示了带有胫骨壁钩和平面检查器附件的触针的使用；
图6示出了根据一个实施例的被切除的股骨和被切除的胫骨以及触针；
图7A-7B示出了可用于维持导航完整性的一个或多个监视标记的实施例；
图8是使用监视标记和触针进行界标检查的实例；
图9A-9B示出了使用触针的一个或多个虚拟界标的实施例；
图10是具有集成的监视标记的动态参考基准件的实施例；
图11A-11B示出了平面检查器的实施例；
图12A-12B示出允许在操作期间无需踩下机器人的脚踏板而进行界标和/或点捕获的触针的实施例；
图13示出了在股骨和胫骨屈曲期间使用的张力器械的实施例；
图14显示了张力器械的实施例；
图15示出了在股骨和胫骨伸展期间使用的张力器；
图16是具有韧带平衡的张力器的实例；
图17是股骨和胫骨的图示，其中动态参考基准件附接到每个骨上；
图18A-18B示出了具有用于安装动态参考基准件的可拆卸手柄的模块化动态参考基准件的实施例；
图19A-19C描绘了插入带有附接手柄的动态参考基准件的集成的桥和销引导件，驱动销穿过桥和销引导件，并且用锁定元件将销锁定到桥上；
图20A-20C描绘了移除手柄、附接参考阵列、调整参考阵列的位置和/或取向以及锁定参考阵列的最终位置的动态参考基准件；
图21示出了在桥和参考阵列之间具有延伸臂的动态参考基准件的实施例；和
图22A-22B示出了可用于将动态参考基准件固定到骨骼的骨销的实施例。
具体实施方式
在膝关节置换术、膝关节成形术或全膝关节成形术(TKA)期间，一个或多个植入物可用于覆盖形成膝关节的股骨和/或胫骨的末端。膝盖包括大腿的股骨或大腿骨，小腿的胫骨或成骨，以及髌骨或膝盖骨。当骨关节炎导致膝关节软骨和/或一根或多根骨骼破裂、类风湿性关节炎导致滑膜发炎或外伤导致膝关节骨骼和/或软骨损伤时，可能需要TKA。尽管在此例示了TKA，但应当理解，其他矫形或其他外科手术可以使用在此描述的装置和系统。为了改善手术结果，手术导航和/或机器人系统可用于导航一个或多个器械和/或协助外科医生进行一个或多个手术。
现在参考图1，示出了在膝关节成形术中进行一个或多个步骤的系统或程序。股骨4和胫骨6被示出为具有附接到每个骨的患者跟踪装置或动态参考基准件26。动态参考基准件26在整个手术过程中跟踪患者的解剖结构。动态参考基准件26可以被配置为由例如图2所示的手术机器人和/或导航系统10跟踪。手术机器人和/或导航系统10可包括例如手术机器人12、一个或多个机器人臂14、基部16(包括计算机平台)、显示器或监视器20(和/或任选的无线平板电脑、耳机等)、末端执行器22以及一个或多个跟踪标记18。末端执行器22可以被配置为固定导管、进入器械或其他适合于执行整形手术中的一个或多个步骤的工具。在图2所示的一个实施例中，进入器械34(例如牵开器)通过关节臂24附接到末端执行器22，并且在图3所示的替代实施例中，用于固定手术锯36的器械保持器(例如被配置为摆动用于切割骨骼的锯片)被连接到末端执行器22。应当理解，合适的器械或装置可以连接到末端执行器22以由机器人12控制。
在导航型和/或机器人辅助的手术中，可以使用参考元件、阵列或动态参考阵列28、42、94跟踪一个或多个器械。参考阵列28、42、94可以包括一个或多个跟踪标记18，它们附接到或可附接到器械并且允许跟踪系统10检测和定位器械在3D空间中的位置。计算机平台与相机跟踪系统或其它3D定位系统组合被配置成实时跟踪参考阵列28、42、94的姿态(例如，方位和旋转定向)。参考阵列28、42、94的3D坐标的跟踪可以允许手术系统10确定参考阵列28、42、94在与患者2的目标解剖结构相关的任何多维空间中的姿态。
手术机器人系统10可包括一个或多个患者跟踪装置或动态参考基准件26、130，其包括一个或多个跟踪标记18，其适于直接固定到患者2(例如，固定到患者2的骨头)。在图1所示的实施例中，第一患者跟踪装置或第一动态参考基准件26固定到股骨4并且第二患者跟踪装置或第二动态参考基准件26固定到患者2的胫骨6。以这种方式，系统10能够在整个手术过程中跟踪股骨4和胫骨6。
手术机器人系统10还可利用例如定位在相机支架32上的相机30。相机支架32可具有任何合适的配置以将相机30移动、定向并支撑在期望的位置。相机30可包括能够标识例如在从相机30的角度可见的既定测量体积中的有源和/或无源跟踪标记18的任何合适的一个或多个相机，如一个或多个红外相机(例如，双焦点或立体摄影测量相机)。相机30可扫描既定测量体积并检测来自标记18的光，以便标识和确定标记18在三维中的位置。举例来说，有源标记18可包括由电信号(例如，红外发光二极管(LED))激活的红外发射标记，并且无源标记18可包括反射红外光的回射标记(例如，它们将入射的IR辐射反射进入入射光的方向)，所述红外光例如由相机30上的照明器或其它合适的装置发射。
手术机器人12能够控制末端执行器22的平移和定向。举例来说，机器人10可能能够沿x轴、y轴和z轴移动末端执行器22。末端执行器22可以配置成用于围绕x轴、y轴和z轴中的一个或多个以及Z框轴线选择性旋转(使得与末端执行器22相关联的一个或多个欧拉角(例如翻滚、俯仰和/或偏转)可以被选择性地控制)。在一些例示性实施例中，对末端执行器22的平移和定向的选择性控制可允许以显著提高的精度执行医疗程序。
机器人定位系统12包括一个或多个计算机控制的机器人臂14，以辅助外科医生计划一个或多个器械相对于术前和/或术中患者图像的位置。系统10可以包括2D和3D成像软件，其允许通过动态参考阵列、导航型器械和相机进行术前规划、导航和引导，用于器械、矫形装置或其他装置的放置。手术机器人和/或导航系统的更多细节可在例如美国专利8,257,360、美国专利公开2019/0021795和美国专利公开2017/0239007中找到，出于所有目的，它们全部通过引用整体并入本文。
现在转向图4A-4C，示出了通用触针器械或触针40的实施例。在导航和/或机器人辅助的手术中，通常需要跟踪多个器械。如果用户希望跟踪不同的器械，可以使用几个不同的参考元件或阵列，每个具有不同的配置。这些独特的配置向导航系统10传达正在使用新器械并重新定义其在3D空间中的位置。因此，为了跟踪许多器械，需要许多相应的参考元件，这增加了成本和复杂性，因为用户不断地获取和配置不同的参考元件。
根据一个实施例，触针40用作通用参考元件。触针40可以插入几种不同的器械中以使每个都可导航，从而消除对许多不同参考元件的需要。如图4A所示，触针40可包括在近端48处具有多个标记18的阵列42、细长主体44和在远端50处的通用快速连接附接尖端46。通用附接尖端46被配置为将触针40快速附接到一个或多个器械并将它们的位置返回到导航系统10。例如，在TKA中，触针40可用于导航自身、附接的平面检查器52、附接的胫骨后壁钩54或任何其他合适的器械。触针40的阵列42上的跟踪标记18可由导航系统10查看并且返回触针尖端46和任何附接器械的位置。
通用触针40可单独使用或与附接的器械(例如，胫骨后壁钩54或平面检查器52)一起使用。通用触针40与器械52、54的机械连接可以允许器械的被导航尖端46(例如，钩子54或平面检查器52的测量表面)和触针参考阵列42的图案之间的功能长度以高水平的可重复性进行控制。通用尖端46可以充当用于由用户快速附接器械的快速连接机构。
在图4B所示的一个实施例中，平面检查器52附接到触针40。通用附接尖端46可以插入并固定到平面检查器52。平面检查器52可包括套环56和脚部58。套环56可以包括纵向开口，该纵向开口被配置为接收触针40的通用尖端46。触针40的通用附接尖端46的尺寸可以设计成使得它与套环56中的开口形成间隙配合。如果需要，弹簧预加载机构可以定位在开口中，使得其将连接部件预加载到参考表面。平面检查器52可以相对于触针40自由旋转。平面检查器52围绕触针40的纵轴A的自由旋转可以允许用户快速重新定向参考阵列42，例如，以确保到相机30的视线。尽管描述了间隙配合，但是可以使用尖端46和平面检查器52之间的任何合适的连接来将组件临时固定在一起。脚部58可包括U形板或其他合适形状的板。脚部58可包括构造成接触骨骼上的切除表面的平坦底表面或平坦部分。当在TKA手术期间使用时，平面检查器52可用于确保切除计划的角度和/或位置与平面匹配。
在图4C所示的另一个实施例中，胫骨后壁钩54附接到触针40。通用附接尖端46可以插入并连接到胫骨后壁钩54。触针40的通用附接尖端46的尺寸可以设计成使得它与套环56中的开口形成位置配合。静态配合可允许胫骨后壁钩54相对于触针阵列42的固定的位置和定向。尽管描述了静态配合，但可以使用尖端46和壁钩54之间的任何合适的连接来将组件暂时固定在一起。壁钩54可包括在其最远端具有扩大的尖端或钩60的套环56。当在TKA手术期间使用时，胫骨后壁钩54可用于定位胫骨壁。
如图1所示，触针40可以单独使用。在这种情况下，动态参考基准件26正在跟踪股骨4和胫骨6的患者解剖结构。触针40可用于诸如界标检查或特征骨表面采集(包括髁突或胫骨平台)之类的任务。在图5A中，胫骨壁钩54已经通过附接尖端46附接到触针40的远端50。例如，当附接到触针40时，钩54可以通过触针跟踪阵列42导航并且用户可以执行点的获取以限定胫骨后壁。在图5B中，用户可以使用附接的平面检查器52来检查切除平面的角度和/或位置。平面检查器52附接到触针40的通用尖端46，并且触针40用作平面检查器52的通用参考元件。由平面检查器52确定的切除平面可以通过导航系统10返回给用户。
现在转向图6，示出了在TKA手术期间已配准患者的切除的股骨4和胫骨6。如图1所示，患者具有插入胫骨6和股骨4的动态参考基准件26，并且在配准完成后，触针40可用于执行界标检查并建立对导航完整性的确信。如在图6中可见的，然而，由于大部分独特的骨解剖结构已被切除，因此切除后的界标检查明显更具挑战性。在机器人和导航的TKA中，重要的是使外科医生确信患者的解剖结构已准确地配准到系统10，并且在整个手术过程中保持准确性。导航完整性可用于描述这种确信。具体而言，在TKA中，由于外科医生可能用作参考点的主要解剖界标在手术过程中被切除，因此在整个手术过程中保持导航完整性可能具有挑战性。
因此，本文所述的一个或多个实施例使用户即使在骨切除术移除了自然界标之后也执行物理界标检查。在此描述的一个或多个实施例提供对动态参考基准件26的监视以确保识别和/或记录与动态参考基准件26的任何相对运动。这些技术有助于提高用户的建立和保持对系统导航完整性的信心的能力。
着重于图7A-7B，根据一个实施例，一个或多个监视标记62可用于在整个过程中保持导航完整性。例如，患者配准可以包括在手术期间不会被切除的区域中在股骨4中添加第一监视标记62和在胫骨6中添加第二监视标记62。如图7B所示，监视标记62可包括主体64，该主体包括终止于远侧尖端68的紧固件66、验证凹痕70和跟踪标记18。紧固件66可包括骨销、螺钉或锚固件，其插入到患者的骨骼解剖结构中。远侧尖端68可以是尖的、锋利的或以其他方式构造成接合骨骼。验证凹痕70可以集成到监视标记62的主体64中。单个跟踪标记18可以附接到标记62的顶部，例如，靠近验证凹痕70。
一旦插入患者体内，监视标记62的位置可以相对于动态参考基准26进行配准。该配准存储监视标记62和动态参考基准件26之间的虚拟距离。如果动态参考基准件26移动(例如，如果它被用户碰撞)，则系统10测量所述距离并在超过移动阈值例如2mm时提醒用户。如果用户想要验证或重新建立导航完整性，则可以使用监视标记62中的验证凹痕66进行额外的界标检查，如图8所示。例如，触针40的尖端46可以插入到监视标记62的验证凹痕70中，从而确认导航完整性。
在图9A-9B所示的替代实施例中，可以用一个或多个虚拟界标72代替监视标记，以便在整个过程中保持导航完整性。例如，第一虚拟界标72可以定位在股骨4中并且第二虚拟界标72可以定位在胫骨6中的将不被切除的区域中。虚拟界标72可以包括紧固件74，例如皮质骨螺钉，具有例如嵌套在螺钉的驱动特征中的验证凹痕76。紧固件74可包括螺纹轴78和扩大的头部80。如图9A所示，手术开始时虚拟界标72可以被插入到患者的骨解剖结构并使用触针40将位置返回到系统10。如果用户想在任何时间(包括切除后)进行术中界标检查，用户只需将触针40的远侧尖端46插入虚拟界标72的凹痕76中。
在图10所示的替代实施例中，监视标记82可以被集成到动态参考基准26中以在整个过程中保持导航完整性。监视标记82可以通过桥84和一个或多个臂86固定在动态参考基准件26上。例如，监视标记82可以固定在桥84上。动态参考基准件26的参考元件和监视标记82之间的距离由系统10存储。如果动态参考基准件26和/或监视标记82围绕指示的轴线碰撞和/或旋转，则距离和/或移动的变化将被系统10识别和记录，并且立即警告用户中断。
在图11A-11B所示的替代实施例中，即使在手术过程中去除了传统解剖界标，平面检查器器械90也可用于保持导航完整性。平面检查器90可以包括具有参考元件或阵列94的主体92，该参考元件或阵列包括多个跟踪标记18、从主体92延伸的轴96以及在轴96的远端处的脚部98。阵列94位于相对于脚部98的已知位置。脚部98可包括U形板或具有平坦底面100的其他合适形状的板。当在TKA手术期间使用时，平面检查器90可用于确保切除计划的角度和/或位置与平面匹配。如图11A所示，在股骨4和/或胫骨6切除之后，脚部98包括可放置在切除平面上的平坦表面100，并且将角度和切割深度返回到系统10。使用这些信息，即使在传统的解剖界标被切除后，用户也能够定位它们的位置并保持导航完整性。
现在转向图12A-12B，示出了触针40的实施例。在导航和机器人TKA中，外科医生可能需要捕获解剖界标或点，以便将患者解剖结构配准到系统10、建立并保持对系统导航完整性的信心和/或定位试验和植入物以比较计划与放置的准确性。图1显示了导航和/或机器人TKA的一种设置。将动态参考基准件26附接到股骨4和胫骨6，并且在被配准之后，系统10能够在3D空间中跟踪每个骨骼的位置。导航触针40可用于界标定位和/或点获取。在一个工作流程中，触针尖端46位于感兴趣的点，并且机器人12上的脚踏板被按下以捕捉系统10上的点。在本实施例中，点捕获取决于外科医生踩下与系统10相连的脚踏板。
如果手术室(OR)地面上脚踏板的位置是未知的，点捕获的脚踏板方法可能有问题。例如，脚踏板可能无意中踢出或移动出外科医生够到的范围。如果发生这种情况，外科医生可能需要将注意力从手术区域转移到寻找脚踏板。此外，连接脚踏板的电缆可能有问题，例如，因为绊倒危险或阻碍OR中设备的自由通行。此外，软件可能需要处理禁用其他功能，例如机器人控制，在启用点捕获功能之前，这些功能也可能链接到脚踏板，这增加了软件算法的复杂性。因此，可能需要包括可以代替传统脚踏板使用的附加实施例。
图12A示出了导航和/或机器人TKA的替代设置。图12A示出了与图1相似的设置，除了在这种设置中，一旦感兴趣点已经被触针尖端46定位，外科医生就可以围绕触针的长垂直轴线旋转触针40一阈值旋转。通过旋转触针40，标记18从第一位置(旋转前)移动到第二位置(旋转后)。触针40可以围绕其轴线旋转阈值旋转，例如大约30°、大约60°、大约180°或任何合适的度数以指示旋转。该旋转由系统10捕获，并且感兴趣点被返回，从而在不踩下脚踏板或其他按钮的情况下由系统10捕获界标。为了确保系统10在外科医生识别点而不是自由移动工具时按预期运行，系统10可以使用算法规则来过滤掉假阳性。例如，当尖端46移动小于给定量(例如，小于0.5mm)时，系统可以检查阈值旋转(例如，至少30°的旋转)发生。例如，如果在30°旋转期间在尖端46处发生大于0.5mm的移动，则忽略点捕获。如果在30°旋转期间在尖端46处发生小于0.5mm的移动，则捕获点/界标。
图12B示出了导航和/或机器人TKA的另一个实施例。图12B示出了与图12A类似的设置，除了在这个实施例中，一旦触针40在感兴趣点或界标上，与阵列42相关联的一个跟踪标记18就可以物理地移动。例如，一个跟踪标记18可以从第一跟踪标记位置18a移动到第二跟踪标记位置18b。通过用拇指或手指按压，同时将触针尖端46固定到位，外科医生可手动移动标记18。系统10检测一个阵列标记18a、18b相对于其他标记的移动并捕获感兴趣点。
在又进一步实施例中，方法可包括通过用户的语音输入进行点捕获；通过阻挡或显示跟踪标记，或者然后阻止在特定时间显示一个或多个标记(例如，相当于“双击”)，进行点捕获；通过另一只手、面部或肘部的姿势进行点捕获，由可见光跟踪捕获和解释；通过将触针定位与节拍器同步来捕捉点，使得在每次节拍时都会捕捉到一个新点，如果骨骼的关节被系统地数字化，这可能有价值；或任何其他合适的点捕获方法或技术。
现在转向图13，显示了张力器械或张力器102，其中股骨4和胫骨6处于屈曲状态。全膝关节成形术(TKA)的目标可以是获得张力对称且平衡的屈曲和伸展间隙。实现这一目标的一种方法是使用间隙平衡技术，其中股骨切口(后股骨4屈曲，远侧股骨4伸展)平行于切除的近侧胫骨6进行，每个侧副韧带均等张紧以获得矩形屈曲和伸展间隙。植入物可以遵循这种平行放置，从而在植入完成后保持张力。
在机器人和/或导航TKA中，患者的解剖结构是被配准到计算系统10。配准后，可以跟踪患者胫骨6和股骨4的相对位置，以允许在计算系统10上实时更新患者间隙测量结果。在张力器102的帮助下，外科医生可以在导航显示器20上查看量化的韧带平衡。张力器102可以通过以下方式促进间隙平衡：(1)在胫骨6和股骨4之间施加牵引力；和/或(2)施加牵引力，使内侧副韧带(MCL)和外侧副韧带(LCL)的张力不同对用户是透明的。
如图13所示，动态参考基准件26刚性连接到患者的胫骨6和股骨4。在配准期间，患者的解剖结构被配准到系统10并通过动态参考基准件26进行跟踪。一旦患者被配准，外科医生就可以进行第一次切除。切除后，张力器102可用于评估间隙平衡。在图13所示的实施例中，近侧胫骨6被切除并且张力器102抵靠切除部放置，同时骨骼保持屈曲。在图15中，近侧胫骨6被切除并且张力器102抵靠切除部放置，同时骨骼被保持在伸展状态。应当理解，可以在股骨优先或胫骨优先的方法之后进行切除。
参考图14，张力器102可以从近端104延伸到远端106。张力器102包括主体108，其具有在远端106处的一对独立的上牵引桨板110和下牵引桨板112；沿主体108的长度延伸的中心轴120，其被配置为相对于下牵引桨板112移动上牵引桨板110；在近端104处的旋钮116，其配置为移动上牵引桨板110；以及围绕轴120的定位在主体108和旋钮104之间的牵引平衡弹簧118。
张力器102被配置为在胫骨6和股骨4之间提供牵引力。张力器102可以允许MCL和LCL张力之间的任何不平衡由定位在张力器102的主体108上的韧带平衡指示器114显示。第一上牵引桨板110可以通过第一杆124连接到韧带平衡指示器114的第一端，并且第二上牵引桨板110可以通过第二杆126连接到韧带平衡指示器的相对端。指示器114可以通过枢轴销128可枢转地连接到主体108。例如，可以通过旋转牵引旋钮116提供牵引力。牵引旋钮116的旋转可以将上牵引桨板110向外平移并远离下牵引桨板112，从而在上牵引桨板110和下牵引桨板112之间提供间隙122。随着张力器102施加牵引力，骨解剖结构将移动。该移动可由导航系统10配准并且可以被显示以供外科医生解释。具体地，股骨和胫骨的运动被相机30通过胫骨和股骨两者上的DRB 26跟踪标记连续捕获(例如，当张力器102被调整时)并且间隙信息由计算机16基于在DRB 26上的跟踪标记的3维位置自动确定而不是由外科医生在张力器上手动查看。变化的间隙信息可以在显示器20中连续显示/更新以供外科医生解释，并且还可以由计算机16使用以自动确定是否需要调整胫骨和/或股骨的计划的切割。在一些情况下，计算机16可以基于自动确定的间隙信息修改计划的切割并且在显示器20上显示修改的切割平面(优选地以类似于图15的相对于骨骼的3-D图形表示，然后外科医生可以使用例如手指或鼠标抓取并使用所有6个自由度或至少俯仰、偏航和滚动在不同方向或角度旋转显示的骨骼、它们的间距和期望的切割平面)，以由外科医生进行检查、批准或修改。间隙数据可以包括股骨和胫骨之间的角度和空间间隔。角度和空间间隔数据可以是3维数据。此外，计算机16的图形用户界面被配置为在显示器20上以图形方式显示原始切割平面和建议的修改的切割平面，优选地以不同颜色例如红色和蓝色，它们重叠在彼此之上以方便外科医生比较。
参考图16，当张力器102被插入并张开在股骨4和胫骨6之间时，张力器102的牵引桨板110、112承受力。例如，牵引力F牵引压在下牵引桨板112上，力FLCL被施加到第一上牵引桨板110，并且力FMCL被施加到第二上牵引桨板110。如果韧带处于平衡状态(FLCL＝FMCL)，如图16所示，韧带平衡指示器114可以指示平衡。例如，韧带平衡指示器114可以显示为大体水平的。如果韧带是不平衡(FLCL＜FMCL、FLCL＞FMCL)，则韧带平衡指示器114可以指示不平衡。例如，韧带平衡指示器114可以显示为大体倾斜的。指示器114的下侧可以指示在相应的上牵引桨板110上的更大的力。指示器114可以指示每个相应力的不平衡量或不平衡程度。
根据一个实施例，使用张力器102的工作流程可以包括以下一项或多项：(1)在骨骼中插入动态参考基准件26并配准患者；(2)进行第一次切除(近侧胫骨6或远侧股骨4)；(3)在伸展时用张力器102检查韧带平衡；(4)相应调整植入计划；(5)进行剩余切除；(6)检查屈伸平衡；(7)根据需要调整切口；(8)插入股骨试片，检查屈伸平衡；(9)必要时调整胫骨计划；(10)按照标准做法完成程序。以此方式，张力器102可促进间隙平衡。通过在胫骨6和股骨4之间施加牵引力，信息可以显示在导航屏幕20上以供用户解释。此外，可以施加牵引力，使得张力器102上的MCL和LCL中不同的张力对用户来说是显而易见的。
现在转向图17，更详细地描述模块化动态参考基准件130的实施例。在机器人和/或导航TKA中，患者的解剖结构是被配准到系统10。通过将一个或多个动态参考基准件130附接到骨骼来促进配准。例如，第一动态参考基准件130可以刚性地附接到股骨4并且第二动态参考基准件130可以刚性地附接到胫骨6。一旦配准完成，动态参考基准件130就能够实时跟踪患者解剖结构。
现在转向图18A-18B，动态参考基准件130可以是模块化的，这可以减少整个过程中使用的器械的数量。模块化动态参考基准件130可以包括参考元件或阵列132，该参考元件或阵列包括多个跟踪标记18、桥134和一个或多个用于将动态参考基准件130固定到骨骼的紧固件或骨销136。阵列132可以包括具有横撑的矩形框架。然而，应当理解，阵列132可以包括用于以期望的配置支撑跟踪标记18的合适的框架。在所示的实施例中，跟踪标记18被放置在矩形框架的每个角处。
可以通过被配置为防止术中导航丢失的一个或多个物理屏障、保护器或罩138来保护跟踪标记18免受污染。例如，四个跟踪标记18中的每一个都可以定位在相应的罩138内。罩138可以为每个单独的跟踪标记18提供保护。罩138可以包括具有倾斜侧面的圆形浅板。应当理解，罩138可以具有用于保护跟踪标记18的任何合适的配置。特别地，可以通过罩138保护跟踪标记18免受污染。
动态参考基准件130可以包括集成的桥134和销引导件140。桥134可以包括一个或多个通孔142和一个或多个被配置成接收骨销136的销引导件140。销引导件140可包括被配置为将骨销136引导到骨中的细长通道。在所示的实施例中，桥134可以包括与第一销引导件140对齐并流体连通的第一开口142和与第二销引导件140对齐并流体连通的第二开口142。例如，开口142和销引导件140可大致平行对齐。应当理解，可以选择开口142和销引导件140的任何合适数量、位置和取向以有效地将桥134附接到骨。动态参考基准件130可以通过骨销136附接到患者。骨销136可以包括自钻骨销。桥134可以用第一锁定螺钉144锁定到销136。集成的桥134和销引导件140可以减少所需器械的数量并简化手术的工作流程。
动态参考基准件130可以通过骨销136和桥134附接到患者。随后，阵列132可以附接到桥134，例如，通过一个或多个腿143。动态参考基准件130可以包括多个腿143，这些腿以不同长度提供用于内切口和外切口，这可以通过促进构建体的外切口和内切口放置来增加工作流程的灵活性。腿143可以固定到阵列132的框架并附接到桥134的远端。例如，如图20A所示，腿143可以通过桥134中的开口141定位。如图20B最佳所见，腿143和附接的阵列132可以被配置为围绕一个或多个轴旋转。例如，腿143和附接的阵列132可能能够围绕桥134的纵向轴线A1和/或垂直于桥134的轴线A2旋转。因此，桥134可有助于围绕两个轴线A1、A2的调节。如图20C所示，在沿一个或多个轴调整之后，阵列132可以用一个或多个锁定螺钉146锁定到位。
如图21所示，可以提供可选的延伸臂或延伸部148以增加参考元件132的定位选项。例如，延伸部148的第一端可以在附加枢轴点150处连接到腿143并且延伸部148的第二端可以连接到桥134。锁定螺钉146可以将延伸部148固定就位。延伸部148可以增加参考元件132的定位选项，从而增加工作流程的灵活性。
为了安装模块化动态参考基准件130，手柄150可以附接到桥134。手柄150可以临时连接到例如桥134的近端。手柄150可以包括例如拇指锁152，以确保在使用过程中手柄150和桥134之间的刚性固定。在安装桥134和骨销136之后，手柄150可以从组件中移除。
安装模块化动态参考基准件130的工作流程可包括以下一项或多项：(1)在患者身上做皮肤切口；(2)将手柄150连接到桥134上(如图19A所示)；(3)插入桥134直到它接触到皮质骨；(4)驱动骨销136穿过桥134(如图19B所示)；(5)使用锁定螺丝144将桥134锁定到销136上(如图19C所示)；(6)取下手柄150；(7)将参考元件132附接到桥134(如图20A所示)；(8)调整参考元件132的方向(如图20B所示)；(9)通过锁定螺丝146锁定调整(如图20C所示)；和(10)可选地，在参考元件132和桥134之间附接延伸部148以促进参考元件132的更多定位选择(如图21所示)。
现在转向图22A-22B，示出了骨销136的实施例。骨销136可用于将动态参考基准件130固定到骨上。骨销136可包括自钻尖端154、切屑提取槽156和骨螺纹158。骨螺纹158可以沿着销136的一部分延伸并且可以具有任何合适的属性，包括旋向性、螺纹角度、导程、螺距等。销136可以包括销驱动器接口160。销驱动器接口160可以包括接合表面，该接合表面被配置为与驱动器器械接口从而安装销136。例如，驱动器接口160可以被配置为将轴向插入力和扭矩传递到销136以促进销136被驱动到患者解剖结构中。
将进一步理解，本领域技术人员可以在不脱离如在权利要求中表达的本发明的范围的情况下对为了解释本发明的本质而描述和图示的部件的细节、材料和布置进行各种改变。本领域技术人员将理解，以上讨论的实施例是非限制性的。还应当理解，一个实施例的一个或多个特征可以部分地或完全地并入本文所述的一个或多个其他实施例中。

Claims (10)

1.一种用于手术期间计算机辅助导航的系统，所述系统包括：
机器人导航系统，其包括计算机、显示器和配置为检测跟踪标记的相机；
第一动态参考基准件，其包括具有多个跟踪标记的第一参考阵列，所述第一动态参考基准件被配置为附接到并跟踪第一骨骼；
第二动态参考基准件，其包括具有多个跟踪标记的第二参考阵列，所述第二动态参考基准件被配置为附接到并跟踪第二骨骼；和
可导航触针，其包括具有多个跟踪标记的第三参考阵列，和通用快速连接附接尖端，其配置为将所述触针快速连接到多个手术器械，其中所述机器人导航系统适于确定附接在所述触针上的所述手术器械的位置。
2.根据权利要求1所述的系统，其中被配置为连接到所述触针的所述一个或多个器械包括胫骨后壁钩。
3.根据权利要求2所述的系统，其中所述胫骨后壁钩包括套环和钩，其中所述套环包括被配置为接收所述通用尖端的纵向开口，并且所述钩被配置为在全膝关节成形术期间定位胫骨壁。
4.根据权利要求1所述的系统，其中被配置为连接到所述触针的所述一个或多个器械包括平面检查器。
5.根据权利要求4所述的系统，其中所述平面检查器包括套环和脚部，其中所述套环包括被配置为接收所述通用尖端的纵向开口，并且所述脚部包括具有平坦底面的U形板，所述U形板被配置为被放置在切除平面上以将角度和/或切割深度返回给所述机器人导航系统。
6.根据权利要求4所述的系统，其中所述平面检查器相对于所述触针的纵轴线自由旋转，从而允许所述第三参考阵列的快速重新定向。
7.根据权利要求1所述的系统，其中所述触针被配置用于界标定位和点获取。
8.根据权利要求7所述的系统，其中一旦所述触针位于界标或感兴趣点上，所述机器人导航系统捕捉所述触针的按阈值旋转的旋转，从而由所述机器人导航系统捕捉所述界标或感兴趣点。
9.根据权利要求8所述的系统，其中所述阈值旋转至少为30°。
10.根据权利要求7所述的系统，其中与所述参考阵列相关联的一个跟踪标记可相对于其他跟踪标记物理地移动，并且一旦所述触针位于界标或感兴趣点上，所述机器人导航系统检测所述一个跟踪标记相对于其他跟踪标记的移动并捕获所述界标或感兴趣点。
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