CN101448468B - 用于验证外科手术装置的校准的系统和方法 - Google Patents

用于验证外科手术装置的校准的系统和方法 Download PDF

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CN101448468B
CN101448468B CN2007800182633A CN200780018263A CN101448468B CN 101448468 B CN101448468 B CN 101448468B CN 2007800182633 A CN2007800182633 A CN 2007800182633A CN 200780018263 A CN200780018263 A CN 200780018263A CN 101448468 B CN101448468 B CN 101448468B
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L·阿拉塔
S·阿利
R·范沃西斯
S·格劳泽
T·布莱克韦尔
R·阿波维奇
M·R·费雷
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Abstract

本发明涉及一种外科手术系统，特别是涉及一种用于验证外科手术装置的校准的外科手术系统和方法。外科手术系统或方法可以设置成进行以下步骤：识别病人的组织体上的界面；确定界面的检测点在参考坐标框架中的位置；使界面与外科手术装置的外科手术工具的一部分接触；确定外科手术工具的该部分在参考坐标框架中的位置；以及判断外科手术工具的该部分的位置是否与检测点的位置预期对应。界面可以包括：病人的骨的抹过部分；在骨中形成的凹窝；或者机械界面，该机械界面包括设置成安装在骨上的部分和设置成与外科手术工具的该部分接触的界面部分。

Description

用于验证外科手术装置的校准的系统和方法
相关申请的交叉引用
本申请要求美国临时专利申请No.60/801378的优先权，该美国临时专利申请No.60/801378的申请日为2006年5月19日，该文献整个被本文参引。
技术领域
本发明涉及一种外科手术系统和方法，特别是涉及一种用于验证外科手术装置的校准的外科手术系统和方法。
背景技术
微创手术(MIS)是指通过比传统外科手术方法使用的切口明显更小的切口来实施外科手术。例如，在矫形用途(例如全膝盖置换手术)中，MIS的切口长度可以在大约4至6英寸的范围内，而普通全膝盖手术中的切口长度典型的是在大约6至12英寸的范围内。由于切口长度更小，MIS过程的侵害性通常比普通的外科手术方法更小，该MIS对软组织的损伤减到最小，减轻了手术后的疼痛，促使更早地活动，缩短了住院时间，并加速康复。
MIS的一个缺点是：小的切口尺寸降低了外科医生观察和接近组织体的能力。例如，在微创矫形关节置换中，有限的观察性和有限的关节接近将增大评估正确植入位置和对骨整形的复杂性。因此，精确布置植入件可能更困难。用于克服该问题的普通技术例如包括：外科手术导航术、定位腿以便使关节最佳暴露、以及利用特别设计的小尺寸仪器和复杂的外科手术技术。但是，这些技术通常需要大量的专业仪器、长期的训练过程以及很高的技巧。而且，单个外科医生和其它不同外科医生的手术结果都没有足够的可预测性、可重复性和/或精确性。因此，植入件的性能和使用寿命在不同病人之间不同。
在矫形用途中，MIS和普通外科手术方法都有的一个缺点是：当骨准备接收植入件时，健康的和病变的骨都除去。例如，全膝盖置换可能需要在膝盖的三个隔腔上各自除去达1/2英寸的骨。
MIS和普通矫形外科手术方法都有的另一缺点是：这些方法都不能以协作的方式来提高外科医生自身的外科手术技能。例如，用于关节置换的一些普通技术包括自动机器人系统来帮助外科医生。不过，这样的系统通常主要用于提高骨的机械加工，即通过利用高速磨光来执行自动切割，或者通过使钻头引导件移动就位，并在外科医生穿过引导件插入切割工具时保持该钻头引导件的位置。尽管这些系统能够精确地进行骨切除，用于提高植入件的配合和放置，但是它们自动作用(而不是与外科医生合作)，因此需要外科医生在一定程度上放弃对机器人的控制。自动系统的另一些缺点包括：机器人的尺寸较大、人机工程性较差、在对齐和切割过程中需要快速夹住骨、增加的切口长度(以便足够机器人进入)，及外科医生和管理部门有限的认可(因为系统的自动特性)。
其它的普通机器人系统包括机器人，该机器人与外科医生协作地相互作用。普通的相互作用机器人系统的一个缺点是，这样的系统缺乏适应外科手术方案的能力以及对手术时的动态环境进行实时导航的能力。例如，美国专利申请No.10/470314(公开号No.US2004/0128026)(该文献整个被本文参引)公开了一种相互作用的机器人系统，该机器人系统编程有三维的虚拟限制区域，该区域与病人对齐。机器人系统包括三自由度(3-DOF)臂，该臂具有包括力传感器的手柄。外科医生利用该手柄来操纵该臂，以便使切割工具运动。需要通过手柄来使臂运动，使得力传感器能够测量由外科医生施加在手柄上的力。然后，测量的力用于控制马达，以便帮助或阻止切割工具运动。例如，在膝盖置换操作中，病人的股骨和胫骨相对于机器人系统固定就位。当外科医生向手柄施加力以便使切割工具运动时，相互作用的机器人系统可以随着切割工具接近虚拟限制区域的边界而施加增大的阻力，以便阻止切割工具运动。这样，机器人系统通过使切割工具保持在虚拟限制区域中而在骨准备中引导外科医生。不过，由于使用上述自动系统，相互作用的机器人系统主要用于提高骨的机械加工。相互作用的机器人系统也需要相关组织体刚性限制，并需要使机器人系统固定在总体位置，因此对于手术时的情况缺乏实时适应能力。而且，臂的3-DOF结构以及外科医生需要利用力手柄来操纵臂将使得灵活性和灵巧性受到限制，从而使得机器人系统不适合某些MIS用途。
因此，需要一种外科手术系统，它能够代替在微创手术中的直接观察，在矫形关节置换用途中节省健康的骨，能够有手术时的适应性和外科手术计划性，并使得产生的手术结果具有充分的可预测性、可重复性和/或精确性(不管外科手术的技能水平如何)。外科手术系统不需要一定满足前述所有或任意要求，不过满足这些要求的系统将更理想。
而且，还需要一种外科手术系统和方法，所述系统和方法能够精确地验证外科手术装置的校准。通过验证外科手术装置的校准，外科手术系统能够向外科手术装置的用户精确地提供位置信息，从而使得用户能够相对于病人的组织体定位外科手术装置，而不管用于MIS的切口尺寸如何，并能够使在外科手术过程中除去的骨的量减到最少。
发明内容
根据本发明的一个方面，一种用于验证外科手术装置的校准的方法，包括以下步骤：识别病人的组织体上的界面；确定界面的检测点在参考坐标框架中的位置；使界面与外科手术装置的外科手术工具的一部分接触；确定外科手术工具的该部分在参考坐标框架中的位置；以及判断外科手术工具的该部分的位置是否与检测点的位置预期对应。
根据另一方面，界面可以包括机械界面，该机械界面包括设置成安装在病人的骨上的部分以及设置成与外科手术工具的该部分接触的界面部分。
根据本发明的一个方面，一种用于验证外科手术装置的校准的系统，包括：外科手术装置的外科手术工具的一部分，该部分设置成与病人的组织体上的界面接触；以及计算系统，该计算系统编程，以便确定界面的检测点在参考坐标框架中的位置、确定外科手术工具的该部分在与界面接触时在参考坐标框架中的位置、以及判断外科手术工具的该部分的位置是否与界面的位置预期对应。
附图说明
附图包含在说明书中，作为说明书的组成部分，表示了本发明的实施例，并与说明书一起用于解释本发明的原理。
图1是本发明的外科手术系统的实施例的透视图。
图2A是本发明的触觉装置的实施例的透视图。
图2B是本发明的触觉装置的实施例的透视图。
图3是本发明的组织体追踪器的实施例的透视图。
图4是安装在触觉装置上的图5A末端执行器的透视图。
图5是本发明的仪器追踪器的实施例的透视图。
图6是本发明的机械追踪系统的实施例的视图。
图7A是本发明的股骨部件的实施例的透视图。
图7B是本发明的胫骨部件的实施例的透视图。
图8表示了本发明的CAS系统的显示器的实施例。
图9是根据本发明实施例的、用于单髁膝盖置换的方法的方框图。
图10是外科手术导航屏幕的实施例的视图，表示了本发明的探针校准验证步骤。
图11是外科手术导航屏幕的实施例的视图，表示了本发明的组织体追踪器安装步骤。
图12是外科手术导航屏幕的实施例的视图，表示了本发明的对齐步骤。
图13是外科手术导航屏幕的实施例的视图，表示了本发明的对齐步骤。
图14是外科手术导航屏幕的实施例的视图，表示了本发明的对齐步骤。
图15是外科手术导航屏幕的实施例的视图，表示了本发明的对齐步骤。
图16是外科手术导航屏幕的实施例的视图，表示了本发明的对齐步骤。
图17是外科手术导航屏幕的实施例的视图，表示了本发明的对齐步骤。
图18是外科手术导航屏幕的实施例的视图，表示了本发明的对齐步骤。
图19是外科手术导航屏幕的实施例的视图，表示了本发明的对齐步骤。
图20是本发明的3D几何触觉物体的实施例的视图。
图21是外科手术导航屏幕的实施例的视图，表示了本发明的检测点识别步骤。
图22是外科手术导航屏幕的实施例的视图，表示了本发明的检测点识别步骤。
图23A是本发明的机械界面500的实施例的剖视图。
图23B是图23A中所示的区域A的放大图。
图24表示了本发明的钝头探针的实施例的剖视图，该钝头探针已经插入机械界面500的界面510中。
图25表示了本发明的6mm磨石的实施例的剖视图，该6mm磨石插入机械界面的界面510中。
图26表示了本发明的2mm磨石的实施例的剖视图，该2mm磨石插入机械界面的界面510中。
图27表示了本发明的铣刀(router)的实施例的剖视图，该铣刀插入机械界面的界面510中。
图28表示了本发明的探针的可选实施例的剖视图，该探针有尖锐端，该尖锐端已经插入机械界面的界面中。
图29表示了本发明的机械界面的实施例的侧视图，该机械界面设置成撞入病人的股骨内。
图30表示了股骨机械界面从另一角度看时的侧视图。
图31表示了本发明的机械界面的实施例的侧视图，该机械界面设置成撞入病人的胫骨内。
图32表示了胫骨机械界面的俯视图。
图33表示了本发明的撞击器/抽取器工具的实施例的平面图。
具体实施方式
附图中表示了本发明的优选实施例。尽管本说明书主要针对涉及膝关节的矫形过程，但是应当知道，这里所述的主题也可用于身体的其它关节，例如肩、肘、腕、脊、髋或踝，也可用于任意其它矫形和/或肌骨骼植入件，包括普通材料的植入件和更特殊的植入件，例如生物矫形件、药物输送植入件以及细胞输送植入件。
图1表示了本发明的外科手术系统10的实施例。外科手术系统10包括计算系统20、触觉装置30和追踪(或定位)系统40。在工作时，外科手术系统10能够执行复杂的、手术时的外科手术计划。当用户执行外科手术过程时，外科手术系统10还向用户(例如外科医生)提供了触觉引导和/或限制触觉装置30的用户操纵。
外科手术系统10可以如美国临时专利申请No.60/801378(申请日为2006年5月19日，该文献整个被本文参引)中所述和如美国专利申请No.11/357197(申请日为2006年2月21日，公开为美国专利公开No.2006/0142657，该文献整个被本文参引)中所述来设置和操作。
计算系统20包括硬件和软件，用于操作和控制外科手术系统10。如图1中所示，计算系统20包括计算机21、显示装置23和输入装置25。计算系统20还可以包括手推车29，该手推车29可以安装在轮子28上。如图1中所示，计算系统20可以通过界面100a而与触觉装置30连接。计算系统20可以编程，以便执行这里所述的任意步骤和特征。
触觉装置30是一种外科手术装置，它设置成由用户操纵，以便使外科手术工具50运动，从而对病人执行手术。在该手术过程中，计算系统20执行控制参数，用于例如根据在病人的组织体和触觉装置30的一部分(例如外科手术工具50)的位置、方位、速度和/或加速度之间的关系而控制该触觉装置30。在一个实施例中，触觉装置30控制成对装置的用户操作提供限制(例如通过限制用户物理操纵触觉装置30的能力)。在另一实施例中，触觉装置30控制成对用户提供触觉引导(即触觉和/或力反馈)。“触觉”是指接触的感觉，且触觉领域涉及与人相互作用装置相关的研究，该与人相互作用装置真正向操作人员提供触觉和/或力反馈。触觉反馈通常包括触感，例如振动，而力反馈是指力(例如运动阻力)和/或力矩(也称为“扭转”)形式的反馈。扭转例如包括呈力、力矩或者力和力矩组合的形式的反馈。例如，触觉引导系统可以设置为如美国专利申请No.11/646204中所述，该美国专利申请No.11/646204的申请日为2006年12月27日，该文献整个被本文参引。
与计算机辅助外科手术(CAS)相连的触觉装置30产生的引导使得外科医生能够主动和精确地控制外科手术动作(例如骨切除)和进行局部药物传送(例如在脑中)。计算系统20可以控制触觉装置30，以便基于工具50相对虚拟物体、参数和/或组织体的位置来产生力、力矩和/或振动。因此，在操作中，当外科医生操纵触觉装置30以便使工具50运动时，可以使用虚拟通路来引导工具50至特定目标，可以使用虚拟边界来确定切割形状或防止工具50与关键组织接触，且可以使用预定参数来限制工具50的行进(例如到预定深度)。计算系统20还可以进行编程，以便在处理过程中根据身体组织体的运动来调节控制参数(例如通过监测身体组织体的检测运动，然后根据该检测运动来调节虚拟物体)。这样，外科手术系统10能够补充或代替外科手术部位的直接观察，提高外科医生的自然触感和身体灵活性，并有利于通过从普通尺寸的入口(例如12英寸或更大长度)至直径小到大约1mm的入口来瞄准、修复和更换身体中的各种结构。
在例如矫形用途中，触觉装置30可以解决在骨(或工件)准备中的不精确、不可预期和不可重复的问题，即通过帮助外科医生正确刮刻骨，从而能够精确、可重复地进行骨切除，同时保持外科医生在骨准备处理中的紧密参与。而且，因为触觉装置30在骨切割操作中触觉引导外科医生，因此外科医生的技能水平不是很关键。因此，具有不同技能水平和经验的外科医生能够进行精确、可重复的骨切除。例如，在一个实施例中，外科手术工具与触觉装置30连接。外科医生能够通过抓住和使工具运动和/或通过抓住和操纵触觉装置30以便使工具运动，从而操作该工具来刮刻骨。当外科医生进行切割操作时，外科手术系统10追踪工具的位置(通过追踪系统40)，且在大部分情况下允许外科医生使该工具在工作空间自由运动。不过，当工具在与病人对齐的虚拟边界附近时，外科手术系统10控制触觉装置30，以便提供触觉引导，该触觉引导将限制外科医生用工具穿透该虚拟边界。例如，虚拟边界可以由触觉物体来确定，且触觉引导可以包括输出扭转(即力和/或力矩)，该输出扭转映射了触觉物体，且外科医生感受该输出扭转为阻止工具朝着虚拟边界方向进一步运动的阻碍作用。触觉物体可以有相关的空间或几何表示，它可以以图像表示在显示装置23上。图像表示可以选择为向用户传达有用信息。例如，如图1中所示，设置成帮助用户引导工具50至外科手术部位的触觉物体300可以图像表示为漏斗形容积。当与物理工具50相对应的虚拟工具运动通过触觉物体300并与该触觉物体300相互作用时，触觉力可以反映给用户，从而使工具50导向外科手术部位。在一个实施例中，确定用于植入件的虚拟切割边界的触觉物体可以在显示装置23上表示为图像，该图像具有与植入件的形状基本相对应的形状。因此，确定股骨部件72的虚拟切割边界的触觉物体208(图7A中所示)可以有相应的图像表示。类似的，确定胫骨部件74的虚拟切割边界的触觉物体206(图7B中表示)可以有相应的图像表示。因此，外科医生可以感觉到就像工具遇到了物理实体，例如墙。这样，虚拟边界起到虚拟切割引导件的作用。因此，触觉装置30将关于工具相对虚拟边界的位置的信息发送给外科医生，并在实际切割处理中提供物理引导。触觉装置30还可以设置成限制用户操纵外科手术工具的能力，例如如美国专利申请No.10/470314(公开号为No.US2004/0128026)中所述，该文献整个被本文参引。
触觉装置30可以包括用于向用户传递触觉反馈(例如振动)和/或力反馈(例如扭转)的机械或机电装置。触觉装置30可以是机器人的、非机器人的、或者是机器人和非机器人组合的系统。例如，触觉装置30可以包括如以下专利文献中所述的触觉装置：美国专利No.7206626；美国专利No.7206627；美国专利申请No.10/384078，申请日为2003年3月6日，公开日为2004年2月19日；美国专利申请No.10/384194，申请日为2003年3月6日，公开日为2004年2月19日；美国专利申请No.10/621119，申请日为2003年7月16日，公开日为2004年6月3日；和/或美国临时专利申请No.60/655642，申请日为2005年2月22日。上述各文献都整个被本文参引。
在一个实施例中，触觉装置30包括机器人。在该实施例中，如图2A中所示，触觉装置30可以包括基座32、臂33、末端执行器35和用户界面37。触觉装置30还可以包括平台39。该平台39可以包括滚转部件38(例如轮子或小脚轮)，以便使平台39能够运动。平台39还包括用于将该平台39固定就位的机构。例如，平台39可以装备有用于滚转部件38的轮锁或制动器、脚踏板锁定装置、千斤顶和/或任意其它已知机构，用于将平台或手推车固定就位。在一个实施例中，如图2A中所示，平台39包括刚性支脚39a，该刚性支脚39a可以通过机构39b而在退回位置(图2A中所示)和伸出位置(未示出)之间驱动。
臂33设置在基座32上，并用于使得触觉装置30能够由用户操纵。臂33可以为任意合适的机械或机电结构，但优选是具有四个或更多自由度(或运动轴线)的铰接臂，例如称为“全臂操纵器(Whole-ArmManipulator)”或WAMTM的机器人臂，它目前由巴雷特科技公司(Barrett Technology Inc.)来制造。臂33包括：近端，该近端布置在触觉装置30的基座32上；以及远端，外科手术工具50与该远端连接。如后面进一步所述，臂33的远端可以包括末端执行器35和/或用于工具50的工具保持器51。在一个实施例中，臂33包括第一区段33a、第二区段33b和第三区段33c，如图2A中所示。第一区段33a和第二区段33b在第一关节33d(例如肩关节)处连接，而第二区段33b和第三区段33c在第二关节33e(例如肘关节)处连接。如图2B所示，臂33可以有例如第一自由度DOF1、第二自由度DOF2、第三自由度DOF3和第四自由度DOF4。因此，区段33a、33b、33c和关节33e、33d形成铰接机械连杆，它可以操纵至各种位置和姿势。臂33的尺寸设置成适合用于各种手术过程，例如矫形、神经科和/或外伤手术过程，且足够紧凑，以便使触觉装置30能够机动，并能够在手术室中有效定位该触觉装置30。例如，臂33的尺寸可以设置为比人的臂稍微更大。在一个实施例中，臂33有大约1m的伸出长度，区段33b和33c的直径为大约89mm。臂33还可以用于容纳和/或布置触觉装置30的部件，例如仪器、电源线、马达、传动部件、控制器、致动器、放大器、制动器、离合器、电源、传感器和/或计算机硬件。
臂33的灵活性例如可以通过增加附加自由度来提高。例如，臂33可以包括腕36。如图2A中所示，腕36可以布置在臂33上(例如在第三区段33c的远端)，并包括一个或多个自由度，以便增大臂33的自由度DOF1、DOF2、DOF3和DOF4。例如，如图2B所示，腕36可以包括自由度DOF5。在一个实施例中，腕36包括两个自由度，且臂33的自由度DOF3省略。腕36还可以是由巴雷特科技公司制造的单自由度或三自由度WAMTM腕。
末端执行器35可以包括触觉装置30的工作端，并可以设置成使得用户能够执行与外科手术过程相关的各种动作。例如，在一个实施例中，末端执行器35用作在臂33和工具50之间的适配器或连接件。通过使工具50与末端执行器35脱开和用另一个工具来与该一个工具50互换，用户可以利用触觉装置30来进行不同动作，例如对齐、骨(或工件)准备、测量/验证、和/或植入件安装。在一个实施例中，如图2A所示，末端执行器35包括：近侧部分，该近侧部分用于与臂33连接；以及远侧部分，该远侧部分包括工具50和/或工具保持器51。末端执行器35的近侧部分可以以任意普通方式而与臂33电连接和机械连接。例如，工具50可以是外科手术工具(例如磨石、钻具、探针、锯等)、医疗装置、显微镜、激光测距仪、照相机、灯、内窥镜、超声波探针、冲洗装置、抽吸装置、放射治疗装置和/或用于外科手术、外科手术计划和/或外科手术导航的任意其它部件。工具50可以是单个工具，或者可以包括多个工具。
外科手术系统10的追踪(或定位)系统40设置成在外科手术过程中确定一个或多个物体的姿势(即位置和方位)，以便检测物体的运动。例如，追踪系统40可以包括检测装置，该检测装置获得物体相对于检测装置的参考坐标框架(或坐标系)的姿势。当物体在参考坐标框架中运动时，检测装置追踪物体的姿势，以便检测(或使得外科手术系统10能够确定)物体的运动。因此，计算系统20能够根据被追踪物体的运动而调节控制参数(例如通过调节虚拟物体)。被追踪物体例如可以包括工具/仪器、病人组织体、植入件/假体装置、工件以及外科手术系统10的部件。利用来自追踪系统40的姿势数据，外科手术系统10也能够使一个空间中的坐标与另一空间中的坐标对齐(或映象或相关)，以便获得空间对齐或对应(例如，利用坐标变换处理，如人们公知)。物理空间中的物体可以与任意合适的坐标系对齐，例如在计算机21和/或计算机31上进行的处理所使用的坐标系。例如，利用来自追踪系统40的姿势数据，外科手术系统10能够使得身体组织体和工具50(和/或触觉装置30)与组织体的表示(例如在显示装置23上显示的图像)相关联。根据被追踪物体和对齐数据，外科手术系统10可以确定例如(a)在组织体的图像和相关组织体之间的空间关系以及(b)在相关组织体和工具50之间的空间关系，这样，计算系统20可以将工具50的虚拟表示在图像上叠加(和持续更新)，其中，虚拟表示和图像之间的关系基本与工具50和实际组织体之间的关系相同。此外，通过不仅追踪工具50还追踪相关组织体，外科手术系统10能够补偿相关组织体在外科手术过程中的运动(例如通过根据检测的运动来调节虚拟物体)。如图1中所示，追踪系统40可以通过界面100b而与触觉装置30连接。
追踪系统40可以为能够使得外科手术系统10持续确定(或追踪)病人的相关组织体的姿势和工具50(和/或触觉装置30)的姿势的任意追踪系统。例如，追踪系统40可以包括非机械追踪系统、机械追踪系统、或者适用于外科手术环境的非机械和机械追踪系统的任意组合。
在一个实施例中，如图1中所示，追踪系统40包括非机械追踪系统。在该实施例中，非机械追踪系统是光学追踪系统，它包括检测装置41和至少一个可追踪元件(或追踪器)，该可追踪元件设置为布置在(或包含于)被追踪物体上，并由检测装置41来检测。如图1中所示，检测装置41可以包括例如立体照相机对，该立体照相机对相对于红外线辐射敏感，并可定位在要进行外科手术过程的手术室中。追踪器设置成以可靠和稳定的方式安装在被追踪物体上，并包括一组标记(例如在图3中的组S1)，该组标记与被追踪物体有已知的几何关系。在工作时，检测装置41检测标记的位置，且独特的几何形状(或触发图形)和与被追踪物体的已知几何关系使得外科手术系统10能够根据标记的位置来计算被追踪物体的姿势。
非机械追踪系统可以包括可追踪元件(或追踪器)，用于用户希望追踪的各个物体。例如，在一个实施例中，非机械追踪系统包括组织体追踪器43(以便追踪病人的组织体)、触觉装置追踪器45(以便追踪触觉装置30的总体或总位置)、末端执行器追踪器47(以便追踪触觉装置30的远端)，和仪器追踪器49(以便追踪由用户人工保持的仪器/工具)。
如图1中所示，组织体追踪器43可以布置在病人的组织体的相关部分(例如骨或工件)上，并用于使得相关组织体能够由检测装置41来追踪。组织体追踪器43包括用于安装在组织体上的固定装置。该固定装置例如可以是骨销、外科手术钉、螺钉、夹子、可佩戴装置、髓内杆等。在一个实施例中，组织体追踪器43设置成在膝盖置换外科手术中使用，以便追踪病人的股骨F和胫骨T。在该实施例中，如图1中所示，组织体追踪器43包括用于布置在股骨F上的第一追踪器43a和用于布置在胫骨T上的第二追踪器43b。如图3中所示，第一追踪器43a包括固定装置和独特的标记(例如反射球)组S1，该固定装置包括骨销P。该组S1安装在连接机构400上，该连接机构400用于可拆卸地固定在两个骨销P上。例如，如图3所示，连接机构400可以包括第一部分442、第二部分444和螺钉445。为了将第一追踪器43a安装在股骨F上，用户将骨销P拧入股骨F中，使连接机构400滑动至骨销P上方，并拧紧螺钉445，以便将第一和第二部分442和444拉至一起，从而将连接机构400牢固固定在骨销P上。一旦固定，连接机构400向骨销P提供附加稳定性。第二追踪器43b与第一追踪器43a相同，除了第二追踪器43b安装在胫骨T上，并有它自身的独特标记组。当安装在病人上时，第一和第二追踪器43a和43b使得检测装置41能够在膝盖置换外科手术过程中追踪股骨F和胫骨T的运动。因此，外科手术系统10能够在外科手术过程中实时补偿骨运动。
如图2A中所示，触觉装置追踪器45布置在触觉装置30上，并用于使得外科手术系统10能够监测触觉装置30在物理空间中的总体位置或总位置。特别是，触觉装置追踪器45使得外科手术系统10能够确定触觉装置30是否相对于外科手术环境中的其它物体(例如病人)运动。这样的信息很重要，因为工具50安装在触觉装置30上。例如，如果当用户在用工具50切割股骨F时有意地重新定位触觉装置30或意外地碰撞触觉装置30，追踪系统40将检测触觉装置追踪器45的运动。在响应时，外科手术系统10可以合适调节在计算机21和/或计算机31上运行的程序，以便补偿触觉装置30(和安装的工具50)相对于股骨F的总体运动或总运动。因此，保持股骨准备处理的完整性。
仪器追踪器49用于与人工握在用户手中的仪器150(与例如安装在末端执行器35上的工具50相反)连接。该仪器150例如可以是探针，例如对齐探针(例如直的或钩形探针)。如图5中所示，仪器追踪器49可以包括独特的标记(例如反射球)组S5，该标记组S5与仪器150形成一体，或者以任意已知方式安装在仪器150上，例如通过机械硬件、粘接剂、焊接、螺纹连接、夹持装置、夹子等。当仪器追踪器49可拆卸地与仪器150连接(例如通过夹子或夹持装置)时，仪器追踪器49将相对仪器150进行校准，以便确定仪器追踪器49和仪器150的几何形状之间的关系。校准可以以任意合适的方式完成，例如通过具有凹窝(divot)或V形槽的工具校准器(例如如美国专利申请No.US2003/0209096中所述，该文献整个被本文参引)。使用夹子或夹持装置来使追踪器49与仪器150连接的一个优点是夹子或夹持装置可以调节，以便与各种尺寸的仪器进行配合。因此，单个夹子或夹持装置可以用于多个仪器。当已知在组S5和仪器150之间的几何关系时，外科手术系统10能够计算仪器150的顶端在物理空间中的位置。因此，仪器150可以用于通过使该仪器150的顶端与物体的相关部分接触而对齐该物体。例如，仪器150可以用于通过接触骨上的界标或在骨表面上的点而与病人的骨对齐。仪器150还可以用于通过使仪器150的顶端与位于植入件上的预定验证特征(例如凹窝)接触来验证安装在病人体内的植入件的正确对齐。
仪器追踪器49还可以设置成验证仪器150的校准。例如，另一追踪器(例如追踪器43、45或47)可以包括凹窝(divot)，用户可以将仪器150的顶端插入该凹窝中。在一个实施例中，如图4中所示，末端执行器追踪器47包括凹窝47a，用户可以将仪器150的顶端插入该凹窝47a中。检测装置41可以再获得用于仪器追踪器49和末端执行器追踪器47的姿势数据，且外科手术系统10可以使得在追踪器47和49之间的实际几何关系与预期几何关系进行比较。在实际和预期几何关系之间的偏差表示仪器150的物理参数(例如平直度、顶端位置等)没有校准。如图15中所示，在验证处理过程中，外科手术系统10可以进行屏幕显示，从而在显示装置23上表示仪器150、仪器追踪器49和末端执行器追踪器47的图像表示。
追踪系统40可以附加或可选择地包括机械追踪系统。与非机械追踪系统相反(该非机械追踪系统包括远离追踪器43、45、47和49的检测装置41)，机械追踪系统可以设置成包括检测装置(例如具有关节编码器的铰接臂)，该检测装置与被追踪物体机械连接(即物理连接)。追踪系统40可以包括任意已知的机械追踪系统，例如如美国专利No.6033415和/或美国专利No.6322567中所述的机械追踪系统，这两篇文献都整个被本文参引。在一个实施例中，追踪系统40包括具有关节连接机械臂241(例如具有六个或更多自由度的铰接臂)的机械追踪系统，该关节连接机械臂241用于追踪病人的骨。如图6中所示，臂241的近端安装在触觉装置30的基座32上，它的可自由运动远端固定在病人的股骨F上。也可选择，近端可以安装在任意其它合适位置(例如手术台的导轨、支脚保持器等上)，但优选是与触觉装置30的基座32连接(例如直接或通过托架)，这样，臂241总体与触觉装置30一起运动。臂241的远端包括固定装置245，该固定装置245用于刚性固定在股骨F上，例如为骨销、骨螺钉、夹子、可佩戴装置、外科手术钉等。臂241设置成具有多个自由度。例如，在一个实施例中，如图6中所示，臂241包括在关节244处连接的多个连杆242。各关节244包括一个或多个位置传感器(未示出)，以便追踪臂241的姿势。位置传感器可以包括任意合适的传感器，例如上面结合触觉装置30的臂33所述的位置传感器。在手术中，当股骨F运动时，臂的远端与股骨F一起运行。位置传感器(和合适的软件)产生臂远端相对于臂近端(该近端固定在触觉装置30上)的姿势的测量。这样，将捕获股骨F相对于触觉装置30的运动。机械追踪系统240还可以包括第二臂，该第二臂与臂241相同，但是刚性安装在胫骨T上，以便使追踪系统240能够追踪胫骨T的运动。这样，机械追踪系统240可以用于追踪股骨F和胫骨T，从而使外科手术系统10能够在外科手术过程中实时检测骨运动。当骨运动数据与合适软件结合使用时，外科手术系统10可以在外科手术过程中实时补偿骨的运动。
当追踪系统40包括机械追踪系统时，臂241可以用于对齐病人的组织体。例如，用户可以利用臂241来对齐胫骨T，同时第二臂(即与臂241相同但固定在胫骨T上的臂)追踪胫骨T的运动。对齐可以例如通过使得臂241的远端的顶端指向胫骨T上的组织体界标和/或通过使胫骨T的表面上的点与臂241的远端的顶端接触(或“涂抹”)而实现。当用户与胫骨T上的界标接触和/或抹过胫骨T表面时，外科手术系统10从臂241中的位置传感器获得数据，并确定臂241的顶端的姿势。同时，第二臂提供与胫骨T的运动相关的数据，这样，外科手术系统10能够在对齐过程中考虑到骨运动。根据骨运动数据和对臂241顶端位置的认识，外科手术系统10能够在计算系统20中使胫骨T与诊断图像和/或病人组织体的组织体模型对齐。类似地，第二臂可以用于对齐股骨F，同时臂241(它安装在股骨F上)追踪股骨F的运动。病人的组织体还可以例如使用非机械追踪系统与被追踪探针的组合(例如仪器150与仪器追踪器49)和/或使用触觉装置30(例如如后面结合图9的步骤S8所述)来对齐。
当有系统问题(例如硬件或软件问题)时、当阻塞检测算法检测到封闭状态(例如如下面结合图9的步骤S11所述)时、和/或当工具50处于不合适位置时，可能存在故障状态。在一个实施例中，外科手术系统10进行编程，以便发出故障信号，并当组织体和工具50的位置、方位、速度和/或加速度之间的关系并不与合适关系相对应时使工具50停用。在一个实施例中，触觉变换(rendering)算法根据由触觉装置30施加给用户的触觉扭转(即力和/或力矩)判断是否超出预定界限。可能激发故障信号的另一情况是当检测到组织体快速运动时。例如当组织体移动时或当某人碰撞安装在组织体上的追踪元件时可能引起快速运动。在一个实施例中，外科手术系统10可以有不同等级的故障。在一个实施例中，外科手术系统10通过使工具50停用和使触觉装置30置于自由模式(而不是施加制动)而响应故障信号，因此，臂33并不拉动组织体或向组织体施加应力。这样外科手术系统10通过当存在不安全情况时防止用户操作工具50和/或臂33来避免损坏。
在一个实施例中，一种基于工具停用特征来控制触觉装置30的方法包括(a)使触觉装置30能够操作；(b)操纵触觉装置30以便在病人身上执行处理步骤；(c)判断在病人的组织体和触觉装置30的工具50的位置、方位、速度和/或加速度之间的关系是否对应于合适关系；以及(d)当该关系并不对应合适关系时发出故障信号。该方法还包括执行控制参数，用于根据该关系来控制触觉装置30，以便提供对用户的触觉引导和对外科手术装置的用户操纵限制中的至少一个。在一个实施例中，响应故障信号，外科手术系统10停止触觉装置30的操作，将触觉装置30的一部分锁定就位，和/或使触觉装置30置于安全模式。在安全模式中，将阻止触觉装置30的操作和/或操纵。
在一个实施例中，一种在外科手术过程中补偿物体的运动的方法包括：(a)确定组织体的姿势；(b)确定工具50的姿势；(c)确定工具50的位置、方位、速度和加速度中的至少一个；(d)使得组织体的姿势、工具50的姿势以及在组织体的姿势和工具50的位置、方位、速度和加速度中的至少一个之间的关系进行关联；以及(e)根据组织体的运动和/或工具50的运动而更新该关联。该关系例如可以基于在组织体以及工具50的位置、方位、速度和/或加速度之间的合适相互作用。在一个实施例中，该关系由虚拟物体或参数来确定，该虚拟物体或参数相对于组织体定位，并表示植入件的合适位置和/或用于安装植入件的切割表面。使组织体的姿势、工具50的姿势和该关系相关联的步骤可以这样实现，即例如使用对齐处理(例如图9的步骤S8)、坐标变换处理和植入计划处理(例如图13的步骤S10和S13)。在一个实施例中，关联的步骤包括(a)确定第一变换，用于使组织体的坐标系变换成组织体的表示的坐标系；(b)确定第二变换，用于使工具50的坐标系变换成组织体的表示的坐标系；以及(c)使所述关系与组织体的表示的坐标系关联。为了使所述关系与组织体的表示的坐标系关联，用户例如可以使虚拟物体相对于组织体的图像定位(例如图9的植入计划步骤S10和S13)。为了使外科手术系统10能够在外科手术过程中补偿物体的运动，使关联更新的步骤可以包括根据组织体的运动来更新第一变换和/或根据工具50的运动来更新第二变换。
在外科手术系统10中包括触觉变换处理的一个优点是触觉变换处理能够在外科手术工具和虚拟环境之间相互作用。触觉变换处理例如可以包括如美国专利申请No.11/646204(该美国专利申请No.11/646204的申请日为2006年12月27日，该文献整个被本文参引)中所述的触觉变换处理。例如，触觉变换处理可以产生虚拟环境，该虚拟环境包括一个或多个虚拟(或触觉)物体和物理工具50的虚拟表示。物理工具50与虚拟环境和/或工具50的虚拟表示相关联(例如对齐)。因此，当用户操纵物理工具50时，工具50的虚拟表示在虚拟环境中与虚拟物体相互作用。这样，物理工具50能够与虚拟环境相互作用。在虚拟物体和工具50的虚拟表示之间的相互作用可以基于点、射线(线)、多个点和/或多边形模型。在优选实施例中，外科手术系统10使用基于点的触觉相互作用，其中，只有虚拟点或触觉相互作用点(HIP)与虚拟环境中的虚拟物体相互作用。HIP对应于触觉装置30上的物理点，例如工具50的顶端。HIP通过虚拟弹簧/阻尼器模型而与物理触觉装置30上的物理点相连。虚拟物体(HIP与它相互作用)例如可以是触觉物体705(图20中所示)，该触觉物体有表面707和触觉力法向矢量Fn。穿透深度di是在HIP和表面707上的最接近点之间的距离。穿透深度di表示HIP穿入触觉物体705中的深度。
在外科手术过程中，计算系统20引导用户通过该过程。例如，计算系统20可以进行编程，以便产生显示，该显示设置成引导用户操纵触觉装置30通过该过程。显示可以包括在显示装置23上表示的屏幕，它包括例如与过程的特定步骤相对应的预定页和/或图像。该显示还促使用户执行一个或多个任务。例如，显示可以教导用户选择在组织体的表示上的组织体界标(下面结合图9的步骤S3和S4介绍)。在一个实施例中，如图8中所示，屏幕可以包括：导航方格600，用于显示与过程的当前步骤相关的图像；被追踪物体方格600，用于显示被追踪物体的相互关系；信息方格604，用于显示与过程的当前步骤相关的信息，例如测量数据、误差数据、状态信息、选择按钮等；以及方格606，用于前进至过程的随后步骤和/或返回前一步骤。
与外科手术过程相关的显示或屏幕可以设置成向用户发送关于该过程的视觉信息。例如，如图8中所示，导航方格600可以产生和显示组织体的表示(例如骨的图像或表示)以及外科手术工具50的表示616。对于骨准备处理，外科手术系统10可以方便执行使得骨准备接收植入件的步骤，即通过产生要从骨上除去的材料部分的表示612，使要除去的材料部分的表示612叠加在骨的表示上，并当用户操纵触觉装置30时由通过工具50实际除去的材料部分的表示614来更新要除去的材料部分的表示612。为了进一步帮助用户，外科手术系统10可在骨和工具50运动时更新骨的表示和工具50的表示616。在一个实施例中，要除去的材料部分的表示612对应于与骨相关(对齐)的虚拟物体部分。因此，虚拟物体表示要从组织体上除去的材料部分。例如，虚拟物体的形状可以与要装配在组织体上的植入件的表面形状相对应(例如在无接合剂植入用途中)。对于有接合剂的植入用途，虚拟物体的形状可以比植入件的形状更大，以便在植入件和骨之间有用于接合剂覆层的空间。上述骨准备步骤例如可以在第一骨(例如胫骨T)上进行，然后对于第二骨(例如股骨F)进行重复。
除了与用户视觉通信，计算系统20还可以编程以便发出听觉信号(例如通过声学装置)。例如，在一个实施例中，计算系统20可以发出声音(例如蜂鸣声)，从而指示工具50的切割深度太浅、近似正确或者太深。在另一实施例中，外科手术系统10可以在与病人对齐时提供在工具50的顶端和触觉物体的表面之间的距离的声音指示，例如在美国专利申请No.10/621119(公开号No.US2004/0106916)中所述，该文献整个被本文参引。计算系统20还可以进行编程，以便控制触觉装置30，从而向用户提供触觉反馈，例如振动，从而指示工具50已经达到或超过合适切割深度。计算系统20的软件还可以包括自动促使用户执行特定任务的程序或处理，例如分段诊断图像数据组的图像、选择在病人组织体上的点以便确定机械轴线、使骨的表面上的点与对齐探针接触(或“抹过”)、输入数据(例如植入件尺寸、磨石尺寸等)等。
图9表示了外科手术系统10用于外科手术计划和单髁膝盖置换导航的方法实施例。图9的方法将只是作为示例。在其它实施例中，方法的步骤顺序可以以适合特定外科手术用途的任意方式重新布置。另外，其它实施例可以包括图9中所示的步骤的全部、一些或仅仅一部分，并可以使图9的任意步骤与现有和/或以后发展的外科手术方法组合。在图9的方法中详细说明的单髁膝盖置换过程用于膝盖的内侧，不过，相同方法也可以用于膝盖的外侧。而且，所示的单髁过程只是示例。外科手术系统10还可以用于执行全膝盖置换过程或涉及植入件安装的其它关节置换过程。植入件可以包括任意植入件或假体装置，例如：全膝盖植入件、单髁膝盖植入件、模块式膝盖植入件、用于其它关节(包括髋、肩、肘、腕、踝和脊)的植入件、和/或其它矫形和/或肌骨骼植入件(包括普通材料的植入件和更特殊的植入件，例如生物矫形植入件、药物输送植入件和细胞输送植入件)。在一个实施例中，植入件是模块式膝盖植入件，如美国专利申请No.11/312741(该文献的申请日为2005年12月30日，公开日为2006年8月24日)或美国专利申请No.11/684514(该文献的申请日为2007年3月9日)中所述，各文献整个被本文参引。
在图9的实施例中，步骤S1至S4在手术前进行，步骤S5至S14在手术中进行。在步骤S1中，病人信息或数据可以输入外科手术系统10中。在步骤S2中，将手术前的诊断图像(例如CT数据文件)装载至外科手术系统10中，并进行分段。在步骤S3中，选择股骨界标。在步骤S4中，选择胫骨界标。在步骤S5中，对触觉装置30进行复位处理，以便初始化触觉装置30的臂33中的位置传感器。在步骤S6中，验证对齐探针的校准。在步骤S7中，组织体追踪器43a和43b安装在病人身上。在步骤S8中，对齐病人组织体。在步骤S9中，校准触觉装置30。在步骤S10中，对胫骨植入件(例如如图7B中所示的胫骨部件74)的初始布置进行计划。初始布置的深度可以由在胫骨坪软骨表面上选定的点来引导，并利用在步骤S8中计算的对齐而将该深度传送至显示装置23的计划屏幕上。在步骤S11中，胫骨T进行准备或刮刻。在步骤S12中，将胫骨试验植入件装配在胫骨T的准备表面上。在步骤S13中，对股骨植入件(例如如图7A中所示的股骨部件72)的初始布置进行计划，例如利用与胫骨试验植入件在腿的各个弯曲的位置相关的点。在步骤S14中，股骨F进行准备或刮刻。在步骤S15中，将股骨试验植入件装配在股骨F的准备表面上。在安装股骨部件72和胫骨部件74之前执行试验缩减处理，其中，用户评估股骨和胫骨试验植入件的配合，并进行任意合适调整(例如重复植入计划和/或骨刮刻)。
对于图13的步骤，更详细的说，在步骤S3和S4中，用户指定在第一骨的表示和第二骨的表示上的界标。例如，在步骤S3中，用户可以在股骨F的图像上指定股骨界标。外科手术系统10利用股骨界标来使病人的身体组织体与组织体的表示(例如诊断图像、由分段产生的模型、组织体模型等)相关联(或对齐)。在一个实施例中，用户可以利用鼠标或接触屏而在显示图像上选择股骨界标。在另一实施例中，计算机可以编程，以便确定股骨界标在图像中的位置，例如利用设计成在诊断图像中定位区别特征的算法。
类似的，在图4中，用户可以在胫骨T的图像上指定胫骨界标。外科手术系统10利用胫骨界标来使病人的身体组织体与组织体的表示(例如诊断图像、由分段产生的模型、组织体模型等)相关联(或对齐)。如图20至23所示，外科手术系统10分别产生屏幕83a、83b、83c和83d，以引导用户指定胫骨界标。例如，外科手术系统10可以引导用户来指定内踝、外踝、旋转界标和膝盖中心。在一个实施例中，用户可以利用鼠标或接触屏而在显示图像上选择胫骨界标。在另一实施例中，计算机可以编程，以便确定胫骨界标，例如利用设计成在诊断图像中定位区别特征的算法。
在步骤S5中，复位处理使触觉装置30的位置传感器(例如编码器)进行初始化，以便确定臂33的初始姿势。复位可以这样进行，例如通过操纵臂33以便使各关节编码器旋转，直到读出在编码器上的索引标记。索引标记是在编码器上的绝对基准，它与关节的已知绝对位置相关联。因此，一旦读出索引标记，触觉装置30的控制系统就知道关节处于绝对位置。当臂33继续运动时，关节的随后位置可以根据绝对位置和编码器的随后位移而进行计算。外科手术系统10可以通过提供关于用户应当将臂33布置的位置的指令来引导用户通过复位处理。这些指令可以包括例如显示在显示装置23上的图像，该图像显示臂33应当运动至的位置。
在步骤S6中，仪器(例如对齐探针，如仪器150)进行检查，以便验证仪器已校准。例如，步骤S6可以用于验证对齐探针已经有合适的物理结构。如上面结合仪器追踪器49所述，包括仪器追踪器49的探针的校准可以这样进行，即通过使探针的顶端插入末端执行器追踪器47的凹窝47a中，使该顶端保持就位，并利用检测装置41来检测仪器追踪器49和末端执行器追踪器47。检测装置41获得姿势数据，且外科手术系统10使得追踪器49和47之间的实际几何关系与在追踪器49和47之间的预期几何关系进行比较。在实际和预期几何关系之间的偏差指示探针的一个或多个物理参数没有校准。如图10中所示，在验证处理过程中，外科手术系统10可以显示屏幕84，该屏幕84显示探针、仪器追踪器49和末端执行器追踪器47在显示装置23上的图像表示。
在步骤S7中，外科手术系统10促使用户将组织体追踪器43a和43b安装在病人身上。如图11中所示，外科手术系统10还可以产生屏幕85，以便使用户能够优化被追踪物体相对于检测装置41的定位。例如，屏幕85可以包括检测装置41的表示85a和检测装置41的视域的表示85b。屏幕还可以显示组织体追踪器43a的表示F1、组织体追踪器43b的表示T1、触觉装置追踪器45的表示H和/或任意其它可追踪元件相对于检测装置41的视域85a的表示。在一个实施例中，各表示F1、T1和H以不同颜色显示，以便使用户在各被追踪物体两两之间进行区分。在另一实施例中，当被追踪物体接近检测装置41的视域边界时，表示F1、T1和H1可以变化成不同颜色。这样，用户可以确定被追踪物体是否充分定位在检测装置41的视域中。
在一个实施例中，一旦安装了组织体追踪器43a和43b，就将获得膝盖关节的运动范围(ROM)(例如通过使膝盖关节在整个ROM中运动，同时由追踪系统40来追踪组织体追踪器43a和43b)。捕获的ROM数据可以用于估计股骨和胫骨植入件的相关布置。这样，用于两个植入件的复杂布置计划可以在切割任何骨之前进行。ROM数据还可以用于在显示装置23上显示股骨和胫骨植入件在延伸、弯曲和在延伸和弯曲之间的各种角度时的相关位置(例如在植入计划步骤S10和S13的过程中)。
在组织体追踪器43a和43b固定在病人身上之后，处理前进至步骤S8，在步骤S8中，病人的身体组织体与组织体的表示对齐。换句话说，身体组织体与图像空间对齐。例如，病人的股骨F和胫骨T可以根据分别在步骤S3和S4中指定的股骨和胫骨界标利用成对点/表面匹配方法而以标准形式来对齐。外科手术系统10产生屏幕，以便引导用户通过对齐处理。例如，屏幕86a(图12)教导用户使股骨F旋转，以便找到腿L的髋部中心。在一个实施例中，在股骨F的旋转过程中，外科手术系统10通过根据组织体追踪器43a的运动确定股骨F的枢转点中心而确定髋部中心。屏幕86b、86c、86d、86e和86f(分别在图27、28、29、30和31中表示)教导用户将对齐探针指向各组织体界标(例如内踝、外踝、内上髁、外上髁、前十字韧带(ACL)附件的后边界等)，并选择界标。例如，用户可以将被追踪的对齐探针的顶端布置在相关界标上，并通过脚踏板或其它输入装置25来选择界标。当用户选择界标时，检测装置41获得与对齐探针的姿势相关的数据，该数据再用于计算界标的位置。根据界标姿势数据和在诊断图像中的界标指定(在步骤S3和S4中)，外科手术系统10通过确定在病人的物理界标和诊断图像中的界标之间的对应而使得身体组织体与诊断图像对齐。基于界标的对齐的精确性可以通过获得股骨F和胫骨T的表面数据而提高。例如，外科手术系统10可以产生屏幕86g(图18)，该屏幕86g教导用户使得股骨F的远端表面上的点与对齐探针接触(或“抹过”)。当用户抹过表面(例如通过使对齐探针的顶端穿过切口128插入)时，外科手术系统10周期性地获得探针顶端的位置，并使获得的顶端位置在屏幕86g上显示为点900。对于由软骨覆盖的骨表面，尖锐的探针可以用于穿刺该软骨，并收集在骨表面上的点(与在软骨表面上的点相对)。类似的，外科手术系统10产生屏幕86h(图19)，并教导用户用对齐探针抹过胫骨T的近端表面。当用户抹过表面(例如通过使对齐探针的顶端穿过切口128插入)时，外科手术系统10周期性地获得探针顶端的位置，并使获得的顶端位置作为点900显示在屏幕上。与股骨相同，尖锐的探针可以用于穿刺任意软骨，从而收集在骨表面上的点(与软骨表面相对)。另外，钩形探针可以用于方便收集在胫骨坪后边缘处的点。步骤S8的对齐处理的结果是使得身体组织体的坐标系与组织体的表示的坐标系相关联的对齐变换。
优选是，步骤S8包括识别在组织体上的至少一个界面，并确定界面的检测点在参考坐标框架中的位置，例如通过当对齐探针与界面接触时数字化该检测点。界面例如可以是在病人的骨上的抹过部分、在骨中形成的凹窝、或者布置在骨上的机械界面。在外科手术过程中，检测点使得用户能够验证外科手术系统10已经正确设置。例如，用户可以使工具50的顶端与界面接触，以便确认追踪系统40合适设置(例如追踪元件没有被阻塞，仍然相对于组织体和/或触觉装置30等合适对齐)，确认工具50正确安装(例如合适就位，轴没有弯曲等)，和/或确认任意其它物体合适安装、装配、校准等。这样，检测点使得外科手术系统10能够确认在使工具50的顶端与病人组织体相关联时涉及的所有元件都保持校准，且追踪元件合适更新。
在一个实施例中，检测点建立如下。在步骤S8中，在定位髋部中心(图12的屏幕86a)之后和在收集任何界标(图13的屏幕86b)之前，用户指定在组织体上的两个界面，这两个界面能够确定两个参考点(或检测点)-在股骨F上的第一界面，用于确定与股骨F相关的第一检测点；以及在胫骨T上的第二界面，用于确定与胫骨T相关的第二检测点。各界面应当布置成这样，它可由对齐探针接近，但是并不位于骨的、将在外科手术过程中除去的部分上。界面例如可以通过以亚甲基蓝(或其它临床标记产品)标记骨、通过(例如使用钻头)在骨上产生小凹窝(例如大约1mm直径)、和/或通过将暂时基准标记(或机械界面)植入在骨上而形成。当界面是骨上的标记或凹窝时，界面自身是包括检测点的组织体参考点。相反，当界面是机械界面时，检测点是根据对齐探针与机械界面的接合而确定的基准，如下面结合机械界面510所述。在一个实施例中，外科手术系统10显示了屏幕186a(图21中所示)，该屏幕186a教导用户识别(例如触摸或接触)股骨F上的第一界面。当用户使第一界面与对齐探针的顶端接触时，外科手术系统10数字化第一检测点，并在组织体追踪器43a的坐标空间中建立点。外科手术系统10还可以教导用户验证(或重新接触)第一界面，以便保证精确捕获第一检测点。然后，外科手术系统10显示屏幕186b(图22中所示)，从而教导用户识别(例如触摸或接触)在胫骨T上的第二界面。当用户利用对齐探针的顶端接触第二界面时，外科手术系统10数字化第二检测点，并在组织体追踪器43b的坐标空间中建立点。外科手术系统10还可以教导用户验证(或重新接触)第二界面，以便保证精确捕获第二检测点。在建立第一和第二检测点之后，用户通过选择界标和抹过股骨F和胫骨T的表面而进行对齐(如上面结合步骤S8所述)。需要时，第一和第二检测点可以变换成图像空间(例如利用在步骤S8中获得的对齐变换)，并在显示装置23上显示，以便帮助评估该对齐的成功性。
根据另一实施例，界面是机械界面，它有设置成安装在组织体上的部分和设置成与仪器接合的部分。例如，机械界面可以设置成与磨石、铣刀、探针等接合。机械界面的一个优点是该机械界面相对于骨和骨坐标系稳定。因此，通过使仪器(例如探针/磨石)能够在具有高度的可重复性的情况下相对于检测点定位，机械界面可以改进检测点验证过程。而且，优选是机械界面可以提供精确验证，因为机械界面并不受到体液或组织的影响而变模糊，也不会由于重复探测而变形。
根据一个实施例，外科手术系统10可以使用机械界面来确定仪器的位置。这样的步骤可以验证仪器相对于病人的组织体是否处于正确位置，并能够验证仪器是否为正确尺寸。这样的验证步骤可以快速地向用户提供有用信息，用于在对病人的组织体进行任何不可逆的切割之前确定系统是否如预期进行和/或是否合适使用。机械界面的检测点的位置可以数字化，例如通过对齐探针，如上面的数字化步骤中所述。而且，机械界面的检测点的位置可以在外科手术处理过程中重复地验证。在另一实例中，不同尺寸的仪器可以与机械界面接触，以便确定在仪器的顶端(例如当仪器是尖锐探针、钝头探针或铣刀时)或仪器的顶端中心(例如当仪器是磨石时)和检测点之间的距离是否小于预定公差。机械界面的检测点可以为任意合适的基准，例如机械界面的一部分(例如表面)、相对于机械界面的一部分确定的基准、或者相对于与机械界面接合的仪器确定的基准。例如，基准可以是相对于机械界面的表面确定的点、线或平面。不过优选是，当探针在机械界面中降到最低点(即尽可能远地插入)时，基准由探针顶端的位置来确定，例如图24中所示的基准Db(用于钝头探针600)或在图28中所示的基准点Ds(用于尖锐探针640)。在一个实施例中，机械界面与仪器的接触可以验证外科手术工具的位置是否与检测点(或基准)的位置如预期对应。如果这样，涉及使病人的组织体与仪器(例如磨石)相关联的所有步骤都正确完成，且所有追踪装置都精确地更新。
根据一个实施例，外科手术系统10可以包括验证检测点系统，该验证检测点系统可以设置成例如对于从机械界面收集的信息进行各种测试。例如，验证检测点系统可以对三种条件进行测试：1)骨追踪器(例如组织体追踪器43a、43b)是否没有运动；2)仪器例如磨石(即外科手术工具50)在末端执行器上的位置是否正确；3)仪器例如磨石是否为正确尺寸。根据还一实施例，验证检测点系统使实际偏移(在仪器的顶端或仪器的顶端中心和机械界面的检测点之间的距离)与理想偏移(当全部三个条件都满足时在仪器的顶端或仪器的顶端中心的预期或理想位置和机械界面的检测点之间的预定距离)进行比较。预定距离从机械界面和工具顶端的已知几何形状来计算。当全部三个条件都满足时，在实际偏移和理想偏移之间的差异将低于预定界限值。例如，1.0mm的预定界限值可以用于验证是否满足全部三个条件。
根据一个实施例，一旦机械界面安装在病人组织体的一部分上，仪器例如钝头探针或磨石可以插入机械界面的界面部分中。例如，机械界面的界面部分可以包括凹窝或者设置成与仪器接合的界面表面。
图23A是根据一个实施例的机械界面500的剖视图。图23B是图23A中所示的区域A的放大图。如图23B的实例中所示，机械界面500可以包括界面510或凹窝，该界面510或凹窝设置成与仪器接合。特别是，界面510可以包括设置成与仪器接合的界面表面520。界面表面520可以有利地将仪器定位在机械界面500的界面510中，从而用于精确确定机械界面500的位置、仪器的尺寸以及这里所述的其它特征。例如，界面表面520可以是锥形或截头锥形表面。这样的界面表面形状可以用作机械放大器，原因在于不同尺寸的仪器的位置可以变化，该变化程度足够被检测到。因为不同尺寸的仪器的位置有这样程度的变化，因此验证检测点系统能够确定哪一种特殊仪器(例如磨石或探针)置于机械界面500的界面510中。
机械界面510的界面510或凹窝可以设计成这样，仪器(例如探针)的顶端将在界面或凹窝内的预定位置处“降至最低点”。为了使仪器降至最低点，外科医生将仪器的顶端插入机械界面510中，直到仪器到达硬停止处，且不能插入更远。然后，预定3D位置成为建立的检测点，它是骨追踪器(例如组织体追踪器43a、43b)的物理空间中的参考点。因为机械界面相对于骨追踪器的位置为已知，因此通过骨追踪器、触觉引导系统、仪器的几何形状和仪器的安装件，还知道仪器顶端的位置，从而知道检测点(或基准)的位置。一旦建立检测点，其它仪器(例如外科手术磨石)可以插入机械界面510中，且仪器的顶端或顶端中心的位置将确定并与检测点的位置比较。具体地说，在机械界面的检测点的位置和仪器的位置(例如仪器顶端的位置或仪器顶端中心的位置)之间的距离可以计算。当该计算距离小于预定值时，验证检测点系统将因此确定外科手术过程继续进行。当不是这样时，外科手术系统10可以设置成向操作人员提供警告，例如视觉警告、听觉警告、或者本领域已知的任意其它警告。例如，在检测点的位置和仪器的位置之间的距离计算可以用于验证组织体追踪器的任何运动，用于验证机械界面对齐的精确性，用于校准触觉引导系统，用于验证仪器在末端执行器中的合适安装，和/或用于验证是否安装了正确的仪器。在另一实例中，机械界面可以用于验证标记组的运动。当该组运动时，新数字化的机械界面将出现在与该机械界面初始数字化时的位置不同的位置处。当在这些位置之间的距离大于预定界限值(例如大约2.00mm)时，该组将认为已经运动，且病人组织体(例如骨)的该部分的对齐必须重新进行。
根据一个实施例，机械界面500的界面510可以设置成具有适合与各种仪器接合的尺寸。例如，如图23A的实例中所示，机械界面500的界面510可以设置成尺寸X1为大约2.0至3.0mm，或者更优选是大约2.5至3.5mm，或者更优选是大约3.0mm；尺寸X2为大约0.5至2.5mm，或者更优选是大约1.0至2.0mm，或者更优选是大约1.5mm；尺寸X3为大约1.0至3.0mm，或者更优选是大约1.5mm至2.5mm，或者更优选是大约2mm；角度D1为大约110°至130°，或者更优选是115°至125°，或者更优选是大约118°；角度D2为大约50°至70°，或者更优选是55°至65°，或者更优选是大约60°。
图24表示了根据一个实施例已经插入机械界面500的界面510中的钝头探针600的剖视图。如图24的实例中所示，钝头探针600可以设置成插入机械界面500的界面510中，这样，钝头探针600降至最低点。当钝头探针600降至最低点时该钝头探针600的顶端的位置可以用于确定检测点，例如基准Db。基准Db例如可以定位成离机械界面500的界面510的表面为距离X4。在一个实施例中，对于钝头探针600，该距离X4可以为大约1.00至3.00mm，或者优选是大约1.50至2.50mm，或者更优选是大约1.88mm。钝头探针600的顶端的位置(即基准Db)将成为建立的检测点，它能够用于确定其它仪器的距离和用于在不同仪器之间进行区分，如下面所述。在由钝头探针600的顶端测量的检测点(基准Db)和要检查的工具的顶端或顶端中心之间的实际距离将进行确定(如上所述)，并与预定值或理想偏移比较。该预定值可能取决于钝头探针600的尺寸和界面510的尺寸，如上所述。也可选择，代替钝头探针600，尖锐探针640可以用于建立检测点。利用尖锐探针640建立的检测点可以对应于基准Ds，该基准Ds是当尖锐探针640在机械界面510中降至最低点时该尖锐探针640的顶端的位置，如图28中所示。
与钝头探针600以及通过使钝头探针600在机械界面510中降至最低点而建立的检测点(由基准Db表示)相比，仪器例如磨石可以设置成具有不同尺寸，这样，不同尺寸仪器具有在检测点和仪器上的位置之间的不同距离。例如，机械界面510可以设置成这样，1mm的磨石可以比钝头探针600更深地插入界面510中，例如深大约0.10至0.30mm，或者更优选是深大约0.26mm。类似地，机械界面510可以设置成这样，2mm的磨石不能像钝头探针600一样深地插入机械界面510中。例如，2mm的磨石可以是浅大约1.28mm。因为1mm磨石和2mm磨石在机械界面510中的不同位置处降至最低点，因此它们离建立的检测点有不同距离。在另一实例中，图25表示了根据一个实施例将6mm磨石610插入机械界面的界面510中的剖视图。确定从6mm磨石610的位置(例如6mm磨石610的顶端中心)至与钝头探针600的顶端相对应的对齐检测点(由基准Db表示)的距离X5。该距离X5再与预定值或理想偏移比较。距离X5和预定值的比较可以用于提供关于机械界面的位置、仪器的类型或尺寸和组织体追踪器的运动的信息以及上述其它信息。根据另一实施例，距离X5可以为大约3.50至5.50mm，或者更优选是大约4.00至5.00mm，或者更优选是大约4.49mm。
图26表示了根据一个实施例插入机械界面的界面510中的2mm磨石620的剖视图。确定从2mm磨石620的位置(例如2mm磨石620的顶端中心)至与钝头探针600的顶端相对应的对齐检测点(由基准Db表示)的距离X6。该距离X6再与预定值或理想偏移比较。距离X6和预定值的比较可以用于提供关于机械界面的位置、仪器的类型或尺寸和组织体追踪器的运动的信息以及上述其它信息。根据另一实施例，距离X6可以为大约0.50至2.00mm，或者更优选是大约0.75至1.75mm，或者更优选是大约1.28mm。
图27表示了根据一个实施例插入机械界面的界面510中的铣刀630的剖视图。例如，铣刀630可以是1.2mm铣刀。确定从铣刀630的位置(例如铣刀630的顶端)至与钝头探针600的顶端相对应的对齐检测点(由基准Db表示)的距离X7。该距离X7再与预定值或理想偏移比较。距离X7和预定值的比较可以用于提供关于机械界面的位置、仪器的类型或尺寸和组织体追踪器的运动的信息以及上述其它信息。根据另一实施例，距离X7可以为大约0.05至0.35mm，或者更优选是大约0.15至0.25mm，或者更优选是大约0.21mm。
图28表示了具有尖锐尖端的探针640的可选实施例的剖视图，该尖锐尖端已经插入机械界面的界面510中。探针640的尖锐尖端使得探针能够更深地插入机械界面的界面510中。因此，更尖锐的探针的几何形状提供了用于探针的对齐检测点，该更尖锐的探针与具有钝头顶端几何形状的探针相比更靠近界面510的底部。当人们希望对齐的检测点(它对应于探针的顶端)更靠近机械界面的界面510的底部时可以使用这样的尖锐顶端几何形状。在一个实施例中，当尖锐探针640用于建立检测点(由基准Ds表示)，在钝头探针600的顶端和基准Ds之间的距离为大约0.5mm；在1mm磨石的顶端中心和基准Ds之间的距离为大约0.24mm；在2mm磨石的顶端中心和基准Ds之间的距离为大约1.78mm；在6mm磨石的顶端中心和基准Ds之间的距离为大约4.99mm。
由于它们的几何形状，一些仪器更容易与其它仪器区分开。例如，6mm磨石具有最大偏移，因此6mm磨石最容易与其它磨石区分，它可以有更类似的偏移值。根据另一实施例，机械界面的界面可以设计成增大在理想偏移之间的差别，并增加检测点验证过程的能力，以便在各种磨石之间区分开。
根据一个实施例，机械界面可以包括用于提醒外科医生在封闭切口之前取出机械界面的特征。例如，缝合线可以安装在机械界面上，且缝合线具有延伸至切口外部的剩余长度，以便用于提醒外科医生在封闭切口之前取出检测点。在另一实例中，外科手术带可以应用在机械界面上，且有用于取出检测点的书面提醒，或者可以提供有警告屏幕，它提醒外科医生取出安装在病人身上的任何检测点。
图29表示了根据一个实施例的机械界面530的侧视图，该机械界面530设置成撞入病人的股骨中。该机械界面530可以用于建立在病人股骨上的参考点。股骨机械界面530可以设置成具有较低型面，以便对软组织的冲撞减到最小。例如，机械界面530可以包括头部部分540和用于插入股骨中的杆550。例如，头部部分540可以包括在圆形凸缘上方的正方形头部，如图29的实例中所示，且杆550可以包括螺纹，以便于该机械界面530插入骨内。图30表示了股骨机械界面530从一个角度看时的侧视图，以便更清楚地表示在机械界面530的头部部分540中的界面510。如图30的实例中所示，股骨机械界面530的界面510可以设置成位于头部部分540的侧部(与头部部分540的顶表面相对)，以便能够在外科手术过程中更容易接近界面510。界面510可以根据这里所述的任意实施例来构成。
图31表示了机械界面560的侧视图，该机械界面560设置成撞入病人的胫骨内。该机械界面560可以用于建立在病人胫骨上的参考点。机械界面560可以包括头部部分570和用于插入胫骨中的杆550。胫骨机械界面560可以设置成具有低的型面，以便对软组织的冲撞减到最小。例如，头部部分570可以包括在圆形凸缘上方的扁平头部，如图31的实例中所示，且杆550可以包括螺纹，以便于该机械界面560插入骨内。图32表示了胫骨机械界面560的俯视图，以便更清楚地表示在机械界面560的头部部分570中的界面510。界面510可以根据这里所述的任意实施例来构成。
图33表示了根据一个实施例的撞击器/抽取器工具700。如图33的实施例中所示，撞击器/抽取器工具700可以有正方形轴710，该正方形轴710设置成装配在机械界面530、560的正方形头部部分540、570上方，这样，机械界面(或检测点)可以“拧入”或“拧出”骨。例如，如图33中所示，轴710的端部可以有凹形部分，该凹形部分包括狭槽720，该狭槽720为大约6mm长，并延伸至轴710的端部。凹形部分还可以包括底切特征。在操作中，外科医生可以使撞击器/抽取器工具700从侧部滑动至检测点530、560上方，这样，检测点530、560的圆形凸缘与底切特征接合。通过使机械界面530、560保持在撞击器/抽取器工具700中，外科医生可以将检测点530、560的顶端定位在骨插入部位上，并通过槌棒撞击在撞击器/抽取器工具700相对端上的撞击垫，以便将机械界面530、560钉入骨中。在插入过程中，狭槽720还可以用作“窗口”，这样，外科医生可以看见机械界面530的方位。为了除去机械界面530、560，外科医生可以使撞击器/抽取器工具700与机械界面接合，如上所述，并从骨上拧下机械界面530、560。
根据一个实施例，机械界面可以由通常用于矫形装置的材料来制造，例如316L SST、17-4PH SST、Ti6AL4V(钛合金)、钛CP(商业纯度)。也可选择，机械界面可以由可生物吸收的材料来制造，这样，检测点可以留在病人体内，最终由病人的身体吸收。例如，机械界面的头部可以在使用后折断，且杆将保留在原位，以便由骨重新吸收。
根据上述实施例，当机械界面安装在骨上时，机械界面的方位可能并不知道。确定机械界面的方位的一种方法是确定界面的长轴的方位或机械界面的凹窝的方位。不过，当机械界面没有被追踪时，凹窝的轴线也不知道。相反，凹窝47A(上面在介绍末端执行器追踪器47时所述)的轴线的位置相对于末端执行器追踪器47上的反射球S4的几何形状为已知。因为球S4由照相机追踪，且已知在球S4和轴线之间的相对几何形状，因此知道凹窝47A的轴线的方位。
根据一个实施例，机械界面可以设置成这样，使得机械界面的方位能够通过例如确定机械界面的凹窝轴线来确定。当不知道机械界面的方位时，验证处理只是检测仪器(例如与机械界面接合的探针的顶端或磨石的顶端中心)是否近似在离检测点的“理想”距离处，该检测点已经预先通过钝头或尖锐探针而建立。因为机械界面的方位并不知道，因此不知道仪器的顶端或顶端中心的预期位置，从而只知道仪器的顶端或顶端中心离建立的检测点的理想距离(基于机械凹窝的几何形状)。为了计算仪器的顶端或顶端中心的预期位置(与前面它离建立的检测点的距离相反)，必须知道或估计机械界面的界面的方位。例如，机械界面的界面的方位可以从当建立用于探针顶端的检测点时钝头或尖锐探针的方位来确定。也可选择，机械界面的界面可以重新设计，这样，它具有用于专门设计的探针的匹配表面，这样，探针置于界面中，从而能够精确确定界面的方位。根据另一实例，机械界面可以被追踪，以便提供它的方位。不过，机械界面将很难追踪，因为它必须足够小，以便不会在外科手术过程中与任何软组织或使用的仪器干涉。因此，添加反射球以便追踪机械界面是不现实的，因为所述球将使得机械界面庞大。不过，机械界面可以通过非光学追踪系统来追踪，例如电磁或射频系统，或者通过传感器，例如RFID传感器。
一旦知道或估计到界面或凹窝的方位，磨石的顶端中心(即磨石中心)的预期位置可以通过简单的公式来计算：
Cb＝Cp+(O＊Ad)
其中，Cb是磨石中心的位置，Cp是由探针拾取的检测点，O是相对磨石中心的偏移(由机械界面的界面的几何形状给出)，且Ad是确定凹窝的中心轴线的矢量，它从基部指向凹窝的顶部。那么，磨石中心的“预期位置”可以直接与磨石中心的实际位置来比较。
根据一个实施例，机械界面可以包括设置成提供关于机械界面的信息的至少一个特征。该特征可以设置成由检测装置来检测，且由该特征提供的信息例如可以包括位置、方位、尺寸、身份(例如部件号)和/或关于机械界面的任意其它有用信息。例如，在操作中，该特征可以用作机械界面的参考点或基准(例如形状、曲线、点、轴线等)。因此，该特征可以用作计算或确定机械界面的位置和/或方位的基础。这样，该特征可以用于提供机械界面的附加自由度。
根据另一实施例，设置成提供关于机械界面的信息的特征可以以任意已知方式与机械界面成一体。例如，该特征可以嵌入机械界面中、安装在机械界面上(例如利用粘接剂)、形成于机械界面的表面上(例如通过蚀刻、切割、印记等)、和/或与机械界面形成一体。该特征可以采取任何形式，它们中的一些将在后面介绍。
根据另一实施例，设置成提供关于机械界面的信息的特征可以设置成可由检测装置(或检测系统)利用任意合适的检测方法来检测(或读出)。例如，该特征可以利用光、电磁、无线电和/或声音方法来检测，如大家公知。作为另外的实例，该特征可以使用激光扫描仪或红外线照相机来检测。作为另外的实例，该特征可以利用可追踪探针或仪器与红外线照相机或具有关节编码器的机械臂组合来检测。检测装置可以在机械界面植入病人体内后读出该特征。
下面介绍一些特定特征和检测装置。本发明并不局限于所述特定特征，它也不局限于所述特征和检测装置的组合。该特征例如可以包括光学特征，例如光学蚀刻(例如激光蚀刻)、光学标记(例如条形码、棋盘图形、或者点的栅格或组)、和/或能够形成或布置在机械界面的表面上的标记物(例如无源红外线标记物)。这样的特征例如可以由例如检测装置(该检测装置包括激光扫描仪或红外线照相机)来检测。
作为另一实例，设置成提供关于机械界面的信息的特征可以包括布置在机械界面的表面上的图形。该图形例如可以包括纹理、槽、蚀刻等。这样的特征例如可以由检测装置来检测，该检测装置包括可以滑过该图形的可追踪探针以及能够检测该探针的红外线照相机。
作为另一实例，设置成提供关于机械界面的信息的特征可以包括界标或表面特征。界标或表面特征可以是机械界面的整体部分或固有部分，它被充分定义和可识别，以便用作可认识的标记物(例如关节表面、组织体结构的轮廓、形状、颜色等)。
能够通过该特征和检测装置而从机械界面传送信息的能力提供了广泛的用途。例如，当该特征向检测装置提供了关于特征的位置和/或方位的信息时，计算装置能够基于该信息和在该特征和机械界面之间的已知几何关系来计算或确定机械界面的位置和/或方位。能够确定机械界面的位置使得能够确定机械界面相对于另一物体、相对于多个其它物体和/或相对于病人骨的定位。例如，计算装置(与检测装置组合)能够计算或确定机械界面相对于一个或多个追踪组(例如组织体追踪器)的位置和方位。然后，计算装置能够使机械界面和追踪器的相对位置与在病人对齐过程中建立的所希望关系进行比较。当实际关系偏离所希望的关系时，可以采取校正动作，例如重复病人对齐。
作为另一实例，特征可以是发射提供信息的一个或多个信号的结构。该特征例如可以发出定向信号，该定向信号具有相对于部件的已知方位。这样的定向信号能够确定机械界面的位置和/或方位。可以用于提供该定向信号的结构例如包括位于机械界面的边缘上的发射器。可以用于检测定向信号的检测装置例如包括能够做三角测量和识别位置的接收器。作为另一实例，信号发射结构可以包括至少一个传感器。传感器例如可以是灵巧标签，例如无源射频识别(RFID)标签。RFID标签安装在机械界面的表面上和/或嵌入机械界面中，并可由发射无线电波的RFID阅读器来检测。当用户用RFID阅读器来扫描机械界面时，无线电波向RFID标签供能，该RFID标签再与RFID阅读器通信。使用信号发射结构的一个优点是，即使当机械界面不可见或不暴露时(例如当机械界面由组织例如肌肉和皮肤覆盖或者由其它组织体阻塞时)，检测装置也可以从该结构获得信息。
在操作时，用户在任何希望确认外科手术系统10的结构的时候(例如当工具50从病人体内抽出和然后重新插入时)，都可以接触股骨和胫骨检测点验证界面。基于在第一和第二检测点的建立过程中获得的几何数据，外科手术系统10知道第一检测点相对于组织体追踪器43a的位置以及第二检测点相对于组织体追踪器43b的位置。基于在触觉装置30的校准过程中获得的几何数据(如下面结合步骤S9所述)，外科手术系统10从触觉装置追踪器45的姿势、触觉装置30的臂33的姿势、工具50的几何形状以及在工具50和末端执行器35之间的几何关系知道工具50的顶端中心的位置。根据这些数据，当用户使工具50的顶端与界面接触时，外科手术系统10能够计算在工具50的顶端中心的位置和相关检测点的位置之间的距离。从该距离中减去工具50的顶端半径以获得校准值。优选是，校准值近似为0.00mm，这表示工具50的顶端的位置和检测点的位置相应。不过允许有一些误差。例如，在一个实施例中，当校准值等于或小于预定公差值(例如大约1mm)时，系统结构将认为可以接受，且用户可以继续进行外科手术过程。相反，当校准值超过预定公差值时，外科手术系统10将发出警告(例如视觉、听觉和/或触觉警告)，指示系统结构的问题。例如，当一个追踪元件由用户在更换工具的过程中撞上且这时错配时、当工具轴弯曲时等可能存在问题。当发出警告时，将重复对齐(步骤S8)和/或校准(步骤S9)。
根据另一实施例，检测点校准系统/方法可以设置成确定仪器(例如探针或磨石)是否以稳定方式位于机械界面内。优选是，稳定位置的确认将确认位置读出以精确方式来进行。为了使得验证处理尽可能精确，例如以便考虑照相机运动和提供一种方法来检测应当进行验证的时间，检测点验证系统/方法可以设置成获取多个磨石顶端位置、计算位置的平均值和计算该位置的标准偏差。通过仪器例如探针来获得机械界面位置将通过平均多个(例如10个)仪器相对骨追踪器的位置读数来进行。与单个测量相比，平均多个位置将更好地估计机械界面的界面位置。例如，系统/方法可以设置成保持移动平均仪器位置，以便计算仪器相对于骨追踪器的估计位置。然后计算在仪器的位置(例如仪器的顶端或顶端中心的位置)和当前表中的各仪器位置之间的距离，且该表距离的标准偏差与界限值比较。当标准偏差低于预定界限值时，探针假定为静态(即静止和不运动)。例如，可以使用大约0.20的界限值，或者更优选是使用0.15。标准偏差可以用于指示仪器已经保持稳定一段时间，因此可以进行机械界面比较。另一测量(例如相对机械界面位置的最大距离)也可以用于确定仪器稳定的时间。
除了检查整个系统结构，检测点还可以用于确定组织体追踪器43a和43b是否已经分别相对于股骨F和胫骨T运动。例如，为了确定组织体追踪器43a是否已经相对于股骨F运动，用户返回检测点识别屏幕(例如图56的屏幕186a)，并使第一检测点重新数字化。当组织体追踪器43a已经运动时，新数字化的检测点将在显示装置23上显示在与初始第一检测点不同的位置处。当在初始第一检测点的位置和新的检测点的位置之间的差值大于预定公差(例如大约2mm)时，外科手术系统10确定组织体追踪器43a已经运动。在这种情况下，将重复进行对齐(步骤S8)。类似地，为了确定组织体追踪器43b是否已经相对于胫骨T运动，用户返回检测点识别屏幕(例如图57的屏幕186b)，并使第二检测点重新数字化。当组织体追踪器43b已经运动时，新数字化的检测点将在显示装置23上显示在与初始第二检测点不同的位置处。当在初始第二检测点的位置和新的检测点的位置之间的差值大于预定公差时，外科手术系统10确定组织体追踪器43b已经运动。在这种情况下，将重复进行对齐(步骤S8)
在一个实施例中，一种使用检测点来验证外科手术系统10的校准的方法包括(a)识别组织体上的界面(例如在骨上的标记、凹窝或者机械界面)；(b)确定界面的检测点在参考坐标框架中的位置(例如组织体的参考坐标框架或者组织体的表示)；(c)使界面与触觉装置30的外科手术工具的一部分接触(例如与工具50的顶端接触)；(d)确定外科手术工具的该部分在参考坐标框架中的位置；以及(e)确定外科手术工具的该部分的位置是否与检测点的位置预期对应。该方法还包括(f)识别在组织体上的第二界面(例如在第二骨上的第二标记、凹窝或机械界面)；(g)确定第二界面的第二检测点在参考坐标框架中的位置；(h)使第二界面与外科手术工具的该部分接触(例如与工具50的顶端接触)；以及(i)确定外科手术工具的该部分的位置是否与第二检测点的位置预期对应。为了确定第一和第二检测点的位置，外科手术系统10可以使第一和第二检测点与组织体的表示(例如在显示装置23上的图像)相关联。在一个实施例中，为了确定外科手术工具的该部分的位置是否与第一或第二检测点的位置预期对应，外科手术系统10判断在工具50的顶端或顶端中心和第一或第二检测点之间的距离是否等于或小于预定值(例如1mm)。
检测点验证过程的一个优点是，该过程使用户能够在对病人的组织体进行任何不可逆的切割之前确认外科手术系统10的各部分如预期进行。例如，检测点可以用于验证对齐、触觉装置30的校准以及追踪系统40和追踪元件的合适操作。因此，检测点使得外科手术系统10能够同时验证组织体追踪器43a和43b的运动、对齐的精确性、触觉装置追踪器45的运动、触觉装置30的动态校准、工具50的合适安装以及正确的工具尺寸。
在步骤S9中，触觉装置30进行校准，以便建立在触觉装置追踪器45的坐标系和触觉装置30的坐标系之间的几何关系或变换(即位置和方位)。当触觉装置追踪器45固定在触觉装置30上的永久性位置时，并不需要校准，因为在追踪器45和触觉装置30之间的几何关系固定和已知(例如由在制造或装配过程中的初始校准)。相反，当追踪器45可相对于触觉装置30运动时(例如当安装追踪器45的臂34可调时)，需要进行校准，以便确定在追踪器45和触觉装置30之间的几何关系。
外科手术系统10可以通过产生教导用户校准触觉装置30的屏幕来开始校准过程。校准包括将触觉装置追踪器45固定在触觉装置30上的固定位置，并暂时将末端执行器追踪器47安装在末端执行器35上。然后，末端执行器35运动至组织体附近的各个位置(例如膝关节上面和下面的位置、膝关节内侧和外侧的位置)，同时追踪系统40获得追踪器47和45在各位置相对于追踪系统40的姿势数据。当触觉装置追踪器45并不相对于触觉装置30运动时，步骤S9的校准处理不需要执行，因为在先的校准和在先获得的校准数据仍然可靠。
在步骤S10中，用户计划骨准备，用于将第一植入件植入至第一骨上。在优选实施例中，第一骨是胫骨T，第一植入件是胫骨部件74，骨准备将通过在胫骨T的近端选择安装胫骨部件74的位置而进行计划。为了方便植入件计划，外科手术系统10可以产生屏幕，该屏幕包括第一和第二骨的各种表示图(即分别胫骨T和股骨F)。
步骤S11至S15包括骨准备处理。在步骤S11中，通过操纵工具50来刮刻第一骨，第一骨(例如胫骨T)准备接收第一植入件(例如胫骨部件74)。在步骤S12中，试验植入件装配在第一骨的准备特征上。在步骤S13中，第二植入件(例如股骨部件)的初始布置进行计划(或者第二植入件可以重复前述计划布置并进行调整)。在步骤S14中，在准备第一骨之后，第二骨(例如股骨F)准备接收第二植入件。在步骤S15中，试验植入件装配在第二骨上的准备特征上。
在整个外科手术过程中，外科手术系统10监测组织体的运动，以便检测组织体的运动，并对在计算机21和/或计算机31上运行的程序进行合适调节。外科手术系统10还可以根据组织体的检测运动来调节与组织体相关的虚拟物体。
在步骤S11中，通过操纵工具50以便刮刻第一骨，第一骨准备接收第一植入件。在一个实施例中，通过在胫骨T的近端上形成中间胫骨凹穴特征，胫骨T进行准备。当安装胫骨部件74时，中间胫骨凹穴特征将与胫骨部件74的表面74a匹配(如图7B中所示)。
阻塞检测算法是在切割操作过程中在与触觉装置30和/或组织体相连的追踪元件(例如触觉装置追踪器45、组织体追踪器43a和43b)变得阻塞时用于减小危险的安全特征。例如在检测装置41不能检测追踪元件时(例如当人或物体置于追踪元件和检测装置41之间时)、当检测装置41的透镜阻塞时(例如由灰尘)、和/或当追踪元件上的标记反射能力被阻塞时(例如由血液、组织、灰尘、骨屑等)，阻塞状态可能存在。当检测到阻塞状态时，阻塞检测算法例如通过使警告信息显示在显示装置23上、产生可听到的声音警告、和/或产生触觉反馈(例如振动)来警告用户。阻塞检测算法还可以向外科手术系统10发出控制信号例如指令，以便切断电源或以其它方式停用工具50。这样，当追踪系统40不能追踪工具50和组织体的相对位置时，阻塞检测算法防止工具50损坏组织体。
步骤S12是试验缩减处理，其中，第一植入件(即胫骨部件74)或试验植入件(例如胫骨试验件)装配在第一骨上(即胫骨T上的准备中间胫骨凹穴特征)。用户评估胫骨部件或胫骨试验件的配合，并可以进行任意合适调整(例如重复植入计划和/或骨刮刻)，以便实现改进配合。
在步骤S13中，在准备第一骨之后，用户计划骨准备，用于在第二骨上植入第二植入件。在优选实施例中，第二骨是股骨F，第二植入件是股骨部件72，且骨准备通过在股骨F远端选择安装股骨部件72的位置来进行计划。当股骨部件72已经预先计划时(例如在步骤S10中)，在先布置可以进行重复，并在需要时进行调节。
在步骤S14中，通过操纵工具50来刮刻第二骨，第二骨准备接收第二植入件。在一个实施例中，股骨F通过在股骨F远端上形成中间股骨表面、杆和龙骨特征来准备股骨F。当安装股骨部件72时，中间股骨表面、杆和龙骨特征将分别与股骨部件72的表面72a、杆72b和龙骨72c匹配(图7A中所示)。股骨特征的准备基本与中间胫骨表面特征的准备类似。
步骤S15是试验缩减处理，其中，第二植入件(即股骨部件72)或试验植入件(例如股骨试验件)装配在股骨F上的准备中间股骨表面、杆和龙骨特征上。用户评估股骨部件72或股骨试验件的配合，并可以进行任意合适调整(例如重复植入计划和/或骨刮刻)，以便改进配合。在步骤S15中，也可以对胫骨T进行调节。当用户对于试验植入件的配合满意时，用户可以进行股骨部件72和胫骨部件74的安装，并完成外科手术过程。
因此，本发明的实施例可以设置成提供触觉引导系统和方法，该系统和方法可以在微创外科手术中代替直接观察，在矫形关节置换用途中节省健康的骨，能够有手术时的适应性和计划性，并使得产生的手术结果具有充分的可预测性、可重复性和/或精确性(不管外科手术的技能水平如何)。
用于控制触觉装置的方法和设备在美国专利申请No.____中(该美国专利申请的标题是用于控制触觉装置的方法和设备，申请人为Hyosig Kang、Dennis Moses和Arthur Quaid，申请日为2007年5月18日，代理人卷号No.051892-0248，该文献整个被本文参引)、在美国专利申请No.____中(该美国专利申请的标题是用于控制触觉装置的方法和设备，申请人为Arthur Quaid、Hyosig Kang和DennisMoses，申请日为2007年5月18日，代理人卷号No.051892-0250，该文献整个被本文参引)和在美国专利申请No.____中(该美国专利申请的标题是用于控制触觉装置的方法和设备，申请人为DennisMoses、Arthur Quaid和Hyosig Kang，申请日为2007年5月18日，代理人卷号No.051892-0253，该文献整个被本文参引)公开。
本领域技术人员通过这里所述的本发明说明书和实施方式显然可以知道本发明的其它实施例。应当知道，说明书和实例只是作为示例。

Claims (16)

1.一种用于验证外科手术装置的校准的系统，包括：
外科手术装置的外科手术切割工具的顶端，该顶端设置成与病人的组织体上的界面接触，其中所述界面构造成由外科手术切割工具的所述顶端接触以便允许验证外科手术装置的校准，所述界面包括安装在病人的骨上的机械界面、病人的骨的抹过部分以及在病人的骨中形成的凹窝中的至少一个；以及
计算系统，该计算系统进行编程，以便：
确定界面的检测点在参考坐标框架中的位置；
确定外科手术切割工具的该顶端在与界面接触时在参考坐标框架中的位置；
判断外科手术切割工具的该顶端的位置是否与检测点的位置具有预期的对应关系，以及
当在外科手术切割工具的顶端的确定位置和检测点的确定位置之间的距离等于或小于预定值时，确定用户可以进行外科手术过程。
2.根据权利要求1所述的系统，其中：外科手术切割工具的该顶端设置成与病人的组织体上的第二界面接触，且计算系统进行编程，以便：
确定第二界面的第二检测点在参考坐标框架中的位置；以及
判断外科手术切割工具的该顶端的位置是否与第二检测点的位置具有预期的对应关系。
3.根据权利要求1所述的系统，其中：计算系统进行编程，以便通过至少使检测点与组织体的表示相关联来确定检测点的位置。
4.根据权利要求1所述的系统，其中：计算系统进行编程，以便至少在外科手术切割工具再次插入病人体内之前判断外科手术切割工具的该顶端的位置是否与检测点的位置具有预期的对应关系。
5.根据权利要求1所述的系统，其中：计算系统进行编程，以便至少利用外科手术切割工具的该顶端的位置是否与检测点的位置具有 预期的对应关系的判断来判断以下的至少一个：病人的组织体是否相对于与组织体相连的追踪元件运动；外科手术切割工具的该顶端是否在参考坐标框架中正确定位；外科手术装置是否相对于与该外科手术装置相连的追踪元件运动；外科手术切割工具是否以合适方位安装在外科手术装置上；以及是否合适的外科手术切割工具安装在外科手术装置上。
6.根据权利要求1所述的系统，其中：该机械界面包括设置成安装在病人的骨上的部分和设置成与外科手术切割工具的该顶端接触的部分。
7.根据权利要求6所述的系统，其中：机械界面至少包括可生物吸收的材料。
8.根据权利要求6所述的系统，其中：机械界面包括截头锥形表面和圆锥表面中的至少一个。
9.根据权利要求8所述的系统，其中：计算系统进行编程，以便确定以下至少一个：外科手术切割工具的该顶端穿入机械界面的截头锥形表面和圆锥表面中的至少一个中的深度；以及在外科手术切割工具的该顶端和检测点之间的距离。
10.根据权利要求6所述的系统，其中，机械界面包括设置成提供关于机械界面的信息的特征。
11.根据权利要求10所述的系统，其中：该特征提供机械界面的位置和方位中的至少一个。
12.根据权利要求10所述的系统，其中，该特征是以下的至少一种：嵌入机械界面中；与机械界面成一体；以及形成于机械界面的表面上。
13.根据权利要求10所述的系统，其中：该特征设置成发射信号，该信号提供信息。
14.根据权利要求1所述的系统，其中：计算系统进行编程，以便判断外科手术切割工具的该顶端的位置是否为静态。
15.根据权利要求14所述的系统，其中，计算系统进行编程，以 便通过以下步骤来判断外科手术切割工具的该顶端的位置是否为静态：
多次确定外科手术切割工具的该顶端在参考坐标框架中的位置；
确定外科手术切割工具的该顶端的多个确定位置的标准偏差；以及
判断该标准偏差是否超过界限值。
16.根据权利要求1所述的系统，其中，构造成与所述界面接触的所述外科手术切割工具的所述顶端具体为外科手术切割工具的顶端中心。 
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