CN101448467A - 用于控制触觉设备的方法和装置 - Google Patents
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Abstract
本发明涉及用于控制触觉设备的方法和装置。提供了一种用于控制外科手术设备的方法。本方法包括操纵该外科手术设备对患者执行一过程;确定在该患者的人体和该外科手术设备的外科手术工具的位置、方向、速度和/或加速度之间的关系是否对应于在该患者的人体和该外科手术工具的位置、方向、速度和/或加速度之间的期望关系;以及如果该关系没有对应于期望关系的情况和/或检测设备无法检测到人体位置和/或外科手术工具位置的情况出现,则对该外科手术设备加以约束。
Description
相关申请的交叉引用
本申请要求于2006年5月19日提交的美国临时专利申请序列号60/801,378的优先权,其全文通过引用结合在此。
技术领域
本发明涉及外科手术系统,尤其涉及用于控制触觉设备(hapticdevice)的方法和装置。
背景技术
微创外科(MIS)是手术切口远小于传统外科手术方法中所用切口的外科手术技术。例如,在诸如全膝关节置换术(total kneereplacement surgery)的整形外科应用中,MIS的切口长度范围在约4至6英寸之间,而传统全膝关节置换术中的切口长度范围则通常在约6至12英寸之间。由于切口长度更短,MIS过程相比于传统外科手术方法侵入性更小,从而最小化软组织损伤、减轻术后痛苦、促进更早下床、缩短住院时间并加快康复。
MIS对外科医生提出了若干挑战。例如,在微创整形外科关节置换中,较小的切口让外科医生更难以查看并接近人体(anatomy),这就增加了骨雕刻及评估适当植入位置的复杂性。结果就使得精确放置植入物变得困难。用于解决这些问题的常规技术包括例如外科手术导航,安置病腿供最优关节暴露,以及利用特别设计的小型化仪器和复杂外科手术技术。然而,这些技术通常需要大量的专用仪器、冗长的训练处理和高度的技术。此外,单个外科医生和各外科医生之间的手术结果是无法充分预测、重复和/或精确确定的。结果就使得各患者的植入物性能和寿命各不相同。
通常为提高微创和传统整形外科关节过程的性能并改善其结果所作出的努力可以包括使用机器人外科手术系统。例如,一些常规技术包括自主(autonomous)机器人系统,诸如ROBODOC系统(以前可以从加利福尼亚州Sacramento的Integrated Surgical Systems,Inc.购得)。然而这些系统一般是通过用高速钻头(burr)执行自主切割而主要用于改善骨加工。虽然这些系统能够实现精密骨切除术来改善植入物的配合与放置,但由于它们是自主动作的(而不是与外科医生协作),这就需要外科医生在一定程度上放弃对机器人的控制。自主系统的其他缺点还包括机器人尺寸大、人机工程差、为让机器人充分接近而增长的切口长度、以及由系统自主特性造成的外科医生和管理机构的接受性(acceptance)受限。这些系统一般还要求在配准和切割期间对骨刚性夹紧,于是就对动态术中场景缺乏实时适应性。
其他的常规机器人系统包括与外科医生协作的非自主机器人,诸如ACROBOT系统(英国伦敦的Acrobot Company Limited)。然而常规交互机器人系统的一个缺点在于这些系统不具备让外科手术导航实时适应动态术中环境的能力。例如,美国专利7,035,716公开了一种用与患者相配准的三维虚拟区域限制编程的交互式机器人系统,该专利的全文通过引用结合在此。该机器人系统包括一个三自由度(3DOF)的臂,该臂具有并入了力传感器的手柄。外科医生利用手柄操纵臂并移动切割工具。需要经手柄来移动臂,使得力传感器能够测量由外科医生施加给手柄的力。测得的力随后用于控制电机辅助或抵抗切割工具的移动。例如,在膝关节置换手术期间,患者的股骨和胫骨相对于机器人系统的位置是固定的。当外科医生向手柄施力以移动切割工具时,该交互式机器人系统就随着切割工具接近虚拟约束区边界而施加程度逐渐增加的阻力来抵抗切割工具的移动。以此方式,机器人系统就通过将工具维持在虚拟约束区域内来指导约束对骨的制备。但如同上述自主系统的情况一样,交互式机器人系统的作用主要也是改善骨加工。另外,臂的3 DOF配置以及对使用力手柄进行臂操纵的外科医生的要求导致其灵活性和灵敏性受到限制,使得该机器人系统不适于某些MIS应用。交互式机器人系统还要求对人体进行刚性限制并要把机器人系统固定在总位置(gross position),于是便对术中场景缺乏实时适应性。
虽然一些交互式机器人系统不要求固定人体,诸如VECTORBOT系统(伊利诺伊州Westchester的BrainLAB,Inc.),但是这些系统无法进行骨雕刻,而仅能用作智能工具指导。例如,这些系统可以控制机械臂以约束钻子沿着预先计划的钻进轨道移动,使得外科医生能够在椎骨上钻孔来放置椎弓根螺钉(pedicle screw)。类似地,其他机器人系统,诸如BRIGIT系统(印第安纳州Warsaw的Zimmer,Inc.)简单安置一机械导轨(tool guide)。例如,在国际公开WO 2005/0122916中公开的机器人系统公开了一种安置机械导轨的机械臂,其全文通过引用结合在此。使用安置导轨的机器人,外科医生手动操纵常规外科手术工具,诸如锯或钻子,以便在机器人约束导轨移动的同时切割患者的人体。虽然这些系统可以增加骨切割的精确性和可重复性,但是它们仅限于执行常规导轨的功能,因此缺乏能让外科医生在骨上雕刻复杂形状的能力,而这一能力正是微创模块化植入物设计中所要求的。
用于骨雕刻的一些非机器人常规外科手术工具不要求相关人体的固定,诸如Precision Freehand Sculptor(宾夕法尼亚州Pittsburgh的Blue Belt Technologies,Inc.)。然而,这些工具的一个缺点在于它们无法以对用户透明的方式起作用。例如,美国专利6,757,582公开了一种可用于在骨上雕刻目标形状的手持外科手术工具,其中该专利全文通过引用结合在此。该手持工具是由外科医生操纵的徒手切割工具,它磨掉骨的各部分以在骨上形成期望的目标形状。目标形状由例如与身体骨(physical bone)配准的基于体元(voxel-based)的模型来定义。在切割期间,跟踪骨和切割工具两者以使得控制器能够确定是否该切割工具正触到该目标形状的边界并会由此切除本应保留的骨。如果是,则控制器可以关闭或者拉回切割工具以保护骨。虽然骨得到保护,但是外科手术工具的操作在外科手术过程中被打断,由此会增加执行过程的时长。此外,切割的打断可能还会导致粗糙的表面切割。另外,这些系统仅仅基于工具相对于目标形状的位置禁用切割工具,而不是实际上约束外科医生对切割工具的操纵,例如防止切割工具和敏感人体之间的接触,也无法解决其他不利情形,诸如检测到人体快速运动的情形。于是,这些系统就可能没有包括足够的安全措施来保护患者。此外,并入关闭机制的手持工具会很庞大并且比标准徒手工具或重力补偿的交互臂更重。这就使得外科医生难以用这一手持工具进行良好的切割运动,这就使得这些工具不适用于要求在骨上雕刻复杂形状的应用,尤其是在微创外科手术环境中,诸如在膝关节置换手术中在不脱开或移开关节的情况下在股骨和胫骨之间的间隙内进行切割。
鉴于前述,就需要这样一种外科手术系统,该系统能够与外科医生协作交互,从而让外科医生能够以微创方式在骨上雕刻复杂形状,并且具有以一种保护患者并对外科医生基本透明的方式动态补偿术中环境内各对象运动的能力。
发明内容
根据本发明的一个方面,一种用于控制外科手术设备的方法,包括:操纵该外科手术设备对患者执行一过程;确定在该患者的人体和该外科手术设备的外科手术工具的位置、方向、速度和/或加速度之间的关系是否对应于在该人体和该外科手术工具的位置、方向、速度和/或加速度之间的期望关系;以及如果该关系没有对应于期望关系和/或检测设备无法检测到人体位置和/或外科手术工具位置,则对该外科手术设备加以约束。
根据另一个方面,一种用于控制外科手术设备的方法,包括:操纵该外科手术设备对患者执行一过程;基于在该患者的人体和该外科手术设备的外科手术工具的位置、方向、速度和/或加速度之间的期望关系约束外科手术设备的操纵;以及如果该期望关系没有被维持和/或检测设备无法检测到人体和/或外科手术工具,则限制外科手术工具的移动和/或外科手术工具的操作。
根据另一个方面,一种用于控制外科手术设备的系统,包括:被配置为由用户操纵以对患者执行一过程的外科手术设备;耦合至外科手术设备的外科手术工具;以及计算系统。该计算系统被编程为确定在该患者的人体和该外科手术工具的位置、方向、速度和/或加速度之间的关系是否对应于在该人体和该外科手术工具的位置、方向、速度和/或加速度之间的期望关系;以及如果该关系没有对应于期望关系和/或检测设备无法检测到人体位置和/或外科手术工具位置,则对该外科手术设备加以约束。
附图说明
并入说明书并作为其一部分的附图示出了本发明的各实施例并且连同描述一起解释了本发明的原理。
图1是根据本发明的一个外科手术系统实施例的透视图。
图2A是根据本发明的一个触觉设备实施例的透视图。
图2B是根据本发明的一个触觉设备实施例的透视图。
图2C是示出了用户操作图2A的触觉设备的该触觉设备的透视图。
图3A是根据本发明的一个末端受动器(end effector)实施例的透视图。
图3B是图3A的末端受动器的侧视图。
图4是根据本发明的一个人体跟踪器实施例的透视图。
图5是根据本发明的一个触觉设备跟踪器实施例的透视图。
图6A是根据本发明的一个末端受动器跟踪器实施例的透视图。
图6B是附至图3A末端受动器的图6A末端受动器跟踪器的透视图。
图7是根据本发明的一个器械跟踪器(instrument tracker)实施例的透视图。
图8是根据本发明示出了一个触觉对象图形表示的实施例的股骨和胫骨的透视图。
图9示出了根据本发明的一个CAS系统显示的实施例。
图10是根据本发明的一个触觉描绘处理(haptic renderingprocess)实施例的框图。
图11是根据本发明的一个3D几何触觉对象实施例的表示。
图12是根据本发明的一个触觉描绘处理实施例的框图。
图13是根据本发明的一个图解说明坐标系和转换的图示表示。
图14是根据本发明的一个遮断(occlusion)检测算法实施例的框图。
具体实施方式
在各附图中图示说明了本发明呈现的各较佳实施例,并努力用相同或相似的编号来指代相同或相似的部分。
图1示出了一个外科手术系统10的实施例。外科手术系统10包括计算系统20、触觉设备30和跟踪系统40。在一个实施例中,外科手术系统10可以是机器人外科手术系统,其在2006年2月21日提交的序列号11/357,197、公开号US 2006/0142657的美国专利申请中公开,该申请全文结合在此作为参考。在一个较佳实施例中,外科手术系统10是可以从佛罗里达州Ft.Lauderdal的MAKO SURGICAL获得的HAPTIC GUIDANCE SYSTEMTM。
计算系统20包括用于操作和控制外科手术系统10的硬件和软件,并且可以包括计算机21、计算机31、显示设备23、输入设备25、以及手推车29。计算系统20适于启用外科手术系统10来执行与外科手术方案制定、导航、图像制导(guidance)和/或触觉制导有关的各种功能。计算机21较佳地专用于外科手术方案制定和导航,并且包括与一般操作、数据存储和检索、计算机辅助手术(CAS)和/或任何其他合适功能性有关的算法、编程和软件实体。与之相反,计算机31较佳地专用于控制触觉设备30的性能、稳定性和/或安全性,并且包括使得触觉设备30能对来自跟踪系统40的数据加以利用的触觉控制实体和程序。
触觉设备30是一种外科手术设备,它被配置为由用户(诸如,外科医生)操纵来移动外科手术工具50以对病人执行一过程,诸如对骨表面进行雕刻以容纳植入物。在此过程中,触觉设备30为外科医生提供触觉制导,例如将工具50维持在预定义的虚拟边界内。如前参考公开US 2006/014265中所公开的,虚拟边界可以由虚拟触觉对象定义,而后者由计算系统20生成并与患者人体相配准(关联)。触觉对象建立起人体和工具50之间的期望关系,诸如工具50相对于人体的期望位置、方向、速度和/或加速度。操作中,当外科医生移动工具50的方式有违期望关系时(诸如当工具50接触虚拟边界时),触觉设备30就以感触式反馈(例如,振动)和/或力反馈(例如,力和/或转矩)的形式向外科医生提供触觉制导。触觉制导可由外科医生体验为例如对朝虚拟边界方向进一步移动工具受阻。结果外科医生会感觉好像工具50遇到了物理对象,诸如一堵墙。以此方式,虚拟边界就起到了虚拟切割指导的作用。于是,外科手术系统10就通过实现基于人体同触觉设备30一部分(诸如工具50)的位置、方向、速度和/或加速度之间关系的控制参数限制了外科医生物理操纵触觉设备30的能力(例如,通过提供触觉制导和/或对用户操纵触觉设备30进行限制)。除了触觉对象之外,上述关系可以基于预定义的参数,诸如限制工具50总行程的预定义深度。
来自与计算机辅助手术(CAS)相耦合的触觉设备30的制导使得外科医生能够主动精确地控制外科手术动作,诸如骨切割以及定位疗法的投送(例如,在脑中)。在整形外科应用中,触觉设备30能够通过指导外科医生对骨进行恰当雕刻来克服骨制备中的不精确、不可预测和不可重复的问题,藉此在维持外科医生在骨制备过程中直接介入的同时提供精确、可重复的骨切除。此外,因为触觉设备30在切割期间对外科医生进行指导,所以外科医生的技术水平也变得不那么关键。于是,技术等级和经验有所不同的外科医生都能够执行精确、可重复的骨切除。
触觉设备30可以是机器人、非机器人、或者是机器人和非机器人系统的组合。在一个实施例中,触觉设备30是如上引用的公开US
2006/0142657中公开的机器人系统。在一个较佳实施例中,触觉设备是可以从佛罗里达州Ft.Lauderdal的MAKO SURGICAL 获得的HAPTIC GUIDANCE SYSTEMTM。如图2A所示,触觉设备30包括基座32、臂33、末端受动器35、用户接口37和平台39。
基座32为触觉设备30提供基础。基座32支持臂33,并且还可以容纳其他组件,诸如控制器、放大器、执行器、电机、传动组件、离合器、制动器、电源、传感器、计算机硬件和/或任何其他周知的机器人组件。
臂33放置在基座32之上并适于让用户能够操纵该触觉设备30。臂33可以是铰接的连接机构(articulated linkage),诸如串行设备、并行设备或者混合设备(即,具有串行和并行元件的设备)。在一个较佳实施例中,臂33是具有四个或以上的自由度(移动轴)的串行设备,诸如当前由Barrett Technology,Inc.生产的被称为“Whole-ArmManipulator(全臂操纵器)”或者WAMTM的机械臂(robotic arm)。臂33包括放置在基座32上的近端,以及包括耦合至外科手术工具50的末端受动器35的远端。为了操纵触觉设备30,用户160简单地抓住并移动臂33(如图2C所示),从而导致工具50移动。在一个实施例中,臂33如图2A所示包括第一段33a、第二段33b以及第三段33c。第一段33a和第二段33b在第一关节33d(例如,肩关节)处相连接,第二段33b和第三段33c在第二关节33e(例如,肘关节)处相连接。如图2B所示,臂33具有第一自由度DOF1、第二自由度DOF2、第三自由度DOF3和第四自由度DOF4。臂33的灵巧性可以通过添加额外的自由度来提高。例如,臂33如图2A所示可以包括放置在第三段33c上的腕36。腕36可以包括一个或多个自由度,诸如自由度DOF5,来扩充自由度DOF1、DOF2、DOF3和DOF4。腕36可以是诸如由BarrettTechnology,Inc.生产的一个或多个自由度的WAMTM腕。
为了能让触觉设备30向用户提供触觉制导,臂33并入驱动系统,诸如在上文引用的公开US 2006/0142657中公开的驱动系统。驱动系统包括执行器(例如,电机)和机械传动机构(transmission)。在一个示例性实施例中,驱动系统包括高速线缆传动机构和零间隙、低摩擦的线缆分速器(cabled differentials)。线缆传动机构可以是例如在当前由Barrett Technology,Inc.生产的WAMTM机械臂中使用的线缆传动机构,和/或在美国专利4,903,536中描述的线缆传动机构,该专利全文结合在此作为参考。
臂33还包括用于确定臂33位置和方向(即,姿态)的位置传感器(未示出),诸如安装在关节33d和33e上的编码器和/或分解器,和/或安装在每个电机转轴上的编码器和/或分解器。
末端受动器35包括触觉设备30的工作端。如图2A所示,末端受动器35包括连接至臂33的近端部分,以及包括工具50和工具夹持器51的远端部分。工具50可以是例如外科手术工具(例如,钻头、钻子、探针、锯等)。在一个实施例中,工具50和工具夹持器51包括电气冷外科手术工具,后者当前由生产并且其产品号为EMAX2(电机)、L-2SB(2mm槽式球(fluted ball))、L-4B(4mm槽式球)、L-6B(6mm槽式球)以及L-IR(12)(1.2mm x 12.8mm槽式刳刨器(fluted router))。外科手术工具还可以包括其他组件,诸如用户输入设备(例如,脚踏板,诸如产品号EMAX2-FP)、控制台(例如,产品号SC2000)等。进一步地,工具50可以集成至外科手术系统10,使得切割信息(例如,速度、扭矩、温度等)对外科手术系统10可用和/或使得外科手术系统10能够控制工具50的操作。
在一个实施例中,工具夹持器51包括被配置为将外科手术工具50耦合至触觉设备30的夹持装置151。如图3B所示,夹持装置151包括第一构件151a和第二构件151b。第一构件151a被配置为容纳工具50的至少一部分(例如,工具50的转轴50a),并与第二构件151b相啮合。第二构件151b被配置为将第一构件151a和外科手术工具50耦合至触觉设备30的末端受动器35,在工具50耦合至末端受动器35时将工具50维持在期望位置,并且基本上防止工具50相对末端受动器35移动。如图3A和3B所示,夹持装置151的第一构件151a可以是套或鞘型的,用来容纳工具50的转轴50a并插入第二构件151b。例如,在一个实施例中,第一构件151a在其第一端(即,其中插入了转轴50a的那一端)的直径范围在约5.9mm至约6.1mm之间,而在其第二端(即,要插入第二构件151b的那一端)的直径范围在约11.38mm至约11.48mm之间。夹持装置151的第二构件151b可以是适于将第一对象(例如,工具或工作件)和第二对象(例如,机器或机器人)以一种安全、稳定并能够重复相对于第二对象安置第一对象位置的方式相耦合的任何连接器。在一个实施例中,第二构件151b包括一夹头。在其他实施例中,第二构件151b可以包括螺纹、夹紧装置、定位螺丝等。
在一个实施例中,夹持装置151被配置为在将该夹持装置151放置在触觉设备30上时使得夹持装置151的轴与工具50的期望轴相对应。例如,在一个实施例中(如图3A和3B所示),夹持装置151的第二构件151b可以包括一连接器,后者包含夹头(collet)151c、夹头旋钮(collet knob)151d和接头螺母(collar nut)151e。在此实施例中,夹头151c包括莫式渐窄凸件(male morse taper feature),而末端受动器35的孔口52则包括相对应的莫式渐窄凹件(female morsetaper feature)。夹头151c与孔口52相配并用接头螺母151e在末端受动器35上拧紧。这一渐窄连接建立了与外科手术工具50的期望轴相对应的轴H-H。如图3B所示,当工具50经由夹持装置151耦合至末端受动器35时,工具50的轴与轴H-H对齐。以此方式,夹持装置151就以相对于末端受动器35的期望配置与工具50对齐。在夹头151c与末端受动器35相配之后,第一构件151a被插入夹头151c。工具50的转轴50a被插入第一构件151a直至工具50的尖端50b处于期望位置。一旦尖端50b被恰当安置,夹头旋钮151d就向下拧紧在夹头151a的指状物或柄脚上。由夹头指施加在第一构件151a上的夹紧力将第一构件151a和工具50固定在原处。以此方式,夹持装置151就实质上阻止了第一构件151a和工具50相对于末端受动器35的移动。一旦被安装在末端受动器35上,工具50的部分50c(图3B中所示)就从末端受动器35中突出并且能够附连至一电机用于驱动工具50。此外,因为夹持装置151和工具50可以与末端受动器35解耦合,所以可以按需移除各组件以供替换、消毒等。
用户接口37能够实现用户和触觉设备30之间的物理交互(physical interaction)。接口37被配置以使得用户能够抓住该接口37并操作工具50同时接收来自触觉设备30的触觉制导。接口37可以是固定至触觉设备30的独立组件(例如,手柄或者把手),或者可以简单地作为触觉设备30现有结构的一部分(诸如臂33)。因为接口37被固定至触觉设备30或者是其一集成部分,所以由触觉设备30输出的任何触觉反馈都可以在用户与接口37相接触时直接传达给用户。于是,接口37能有利地让触觉设备30与外科医生协作以持有工具50(如图2C所示)并在同时提供触觉制导。
外科手术系统10的跟踪系统40被配置为在外科手术过程中跟踪一个或多个对象以检测这些对象的移动。如上文引用的公开US2006/0142657所描述。跟踪系统40包括检测设备,用来获取一对象相对于检测设备41的参考坐标框架的姿态(即,位置和方向)。当该对象在参考坐标框架中移动时,检测设备跟踪该对象。对象姿态的改变指示该对象已经移动。作为响应,计算系统20对触觉设备30的控制参数做出合适的调节。例如,当人体移动时,计算系统20对与人体相配准的虚拟触觉对象(例如,虚拟切割边界)做出相应的调节。于是,该虚拟切割边界就连同人体一起移动。
来自该跟踪系统40的姿态数据还可例如使用坐标变换过程,用来将一个空间内的坐标配准(即,映射或者关联)至另一个空间的坐标以实现空间对齐。配准包括任何已知的配准技术,诸如图像对图像配准、图像对物理空间配准、和/或组合的图像对图像和图像对物理空间配准。在一个实施例中,人体和工具50(在物理空间中)被配准至人体表示(诸如,图像空间中的图像614),这在上文引用的公开US2006/0142657中公开并在图9中示出。基于配准和跟踪数据,外科手术系统10能够确定(a)人体和图像614之间的空间关系,以及(b)人体和工具50的空间关系,使得计算系统20能够叠加并持续更新工具50在图像614上的虚拟表示。虚拟表示616和图像614之间的关系基本上等同于工具50和实际人体之间的关系。
跟踪系统40可以是能让外科手术系统10持续确定(或者跟踪)患者相关人体的姿态和工具50(和/或触觉设备30)的姿态的任何跟踪系统。例如,跟踪系统40可以包括非机械跟踪系统、机械跟踪系统、或者适于在外科手术环境中使用的任何非机械和机械跟踪系统的组合。
在一个实施例中,跟踪系统40包括如图1所示的非机械跟踪系统。非机械跟踪系统是包括检测设备41和可跟踪元件(或跟踪器)的光学跟踪系统,其中将可跟踪元件(或跟踪器)配置为置于被跟踪对象上并可由检测设备41所检测。在一个实施例中,检测设备41包括基于可见光的检测器,诸如用于检测跟踪元件上图案(例如,棋盘形图案)的微米跟踪器。在另一个实施例中,检测设备41包括对红外辐射敏感并且可以安置在要执行外科手术过程的手术室内的立体摄像机对。跟踪器被配置为以牢固稳定的方式固定在被跟踪对象上并且包括与被跟踪对象具有已知几何关系的标示器阵列(例如,图4中的阵列S1)。众所周知,标示器可以是有源的(例如,发光二极管或LED)或是无源的(例如,反射球、棋盘形图案等)并且具有唯一的几何结构(例如,唯一的标示器几何排列),或者在有源、有线标示器的情况下,具有唯一的钻孔布置图案(firing pattern)。操作中,检测设备41检测标示器的位置,并且外科手术系统10(例如,使用嵌入式电子品的检测设备41)基于标示器的位置、唯一几何结构以及与被跟踪对象的已知几何关系来计算被跟踪对象的姿态。跟踪系统40包括对用户想跟踪的每个对象进行跟踪的跟踪器,诸如人体跟踪器43(跟踪患者人体)、触觉设备跟踪器45(跟踪触觉设备30的全局或总位置)、末端受动器跟踪器47(跟踪触觉设备30的远端)以及器械跟踪器49(跟踪由用户手持的器械)。
人体跟踪器43放置在患者人体上并使得人体可由检测设备41跟踪。人体跟踪器43包括用于附连至人体的固定装置,诸如骨钉、外科手术钉、螺钉、夹钳、髓内针等。在一个实施例中,人体跟踪器43被配置为用于在膝关节置换手术期间跟踪患者的股骨F和胫骨T。在此实施例中,如图1所示,人体跟踪器43包括适于放置在股骨F上的第一跟踪器43a以及适于放置在胫骨T上的第二跟踪器43b。如图4中所示,第一跟踪器43a包括含骨钉P、夹钳400、及唯一标示器(例如,反射球)阵列S1的固定装置。第二跟踪器43b等同于第一跟踪器43a,除了第二跟踪器43b是安装在胫骨T上并有其自身的唯一标示器阵列之外。当被安装在患者身上时,第一跟踪器43a和第二跟踪器43b能让检测设备41跟踪股骨F和胫骨T的位置。
触觉设备跟踪器45被放置在触觉设备30上并能让外科手术系统10监视该触觉设备30在物理空间内的全局或总位置,使得外科手术系统10能够确定触觉设备30是否已相对于外科手术环境中诸如患者的其他对象移动,或者确定检测设备41是否已经相对于触觉设备30移动。这些信息很重要,因为工具50是附连至触觉设备30的。例如,如果用户在用工具50切割股骨F时改变了触觉设备30的位置或者因疏忽碰到了触觉设备30,那么跟踪系统40将会检测到触觉设名跟踪器45的移动。作为响应,外科手术系统10能够对在计算系统20上运行的程序做出恰当的调节以补偿触觉设备30(及其附连的工具50)相对于股骨F的移动。结果就能维持骨制备处理的完整性。
触觉设备跟踪器45包括唯一的标示器(例如,反射球)阵列S3并且适于安装在触觉设备30的基座32上,以使得跟踪器45能相对于基座32放置在固定位置上。固定位置在触觉设备配准校准期间(如下讨论)校准至触觉设备30,使得外科手术系统10知道跟踪器45相对于基座32的定位。一旦被校准,就在外科手术过程中维持该固定位置。在一个实施例中,如图2A和图5所示,跟踪器45被安装在臂34上,并具有连接至基座32的近端(例如,经由螺丝、铆钉、焊接、夹钳、磁体等)以及载有标示器阵列S3的远端。臂34可以包括一个或多个具有刚性结构的支持构件(例如,托架、支杆、杆件等),使得触觉设备跟踪器45相对于触觉设备30被永久固定在一位置上。然而臂34优选地具有可调节性使得阵列S3可相对于触觉设备30移动。于是,阵列S3可以在牢固固定于一位置之前独立于基座32安置。结果就能(例如,基于病人体形、手术台高度等)为每个外科手术病例定制阵列S3的位置并设置以使其不会在外科手术过程中对外科医生有所妨碍。
能够以任何已知的方式为臂34提供可调节性(例如,铰接连接机构、灵活颈等)。例如,在图5的实施例中,臂34包括其上放置有触觉设备跟踪器45的球窝关节34b。球窝关节34b包括由手柄34a开动的锁紧机构。操作中,用户可以拧开手柄34a以松开球窝关节34b,操纵球窝关节34b直至跟踪器45处于期望位置,并拧紧手柄34a直至球窝关节34b被牢固固定。以此方式,跟踪器45就可被固定在期望位置。作为将跟踪器45牢固固定在一位置并相对于触觉设备30校准该固定位置的替换,臂34可以包括与臂33的位置传感器相类似的位置传感器(例如,编码器),用以提供臂34相对于基座32的姿态的测量。当位置传感器并入臂34时,就没有必要进行触觉设备配准校准(如下讨论),这是因为外科手术系统10能够基于由位置传感器提供的臂34的姿态来确定跟踪器45相对于基座32的位置。
末端受动器跟踪器47能让外科手术系统10确定触觉设备30远端的姿态。优选地将跟踪器47配置为放置在臂33远端的触觉设备30上(例如,在段33c、末端受动器35、工具50和/或工具夹持器51上)。在一个实施例中(如图6B所示),跟踪器47被放置在工具夹持器51上。如图6A所示,跟踪器47可以包括唯一的标示器(例如,反射球)阵列S4并且适于按任何已知方式固定至触觉设备30,诸如用夹紧装置、螺纹连接、磁体等。在图6A的实施例中,用夹钳1500将跟踪器47固定至触觉设备30。夹钳1500可以与阵列S4集成形成,或者可以用任何已知的常规方式固定至阵列S4,诸如用机械硬件、黏合剂、焊接等。夹钳1500包括第一部分1505、第二部分1510、以及翼形螺钉1515。第一部分1505和第二部分1510被成型为容纳触觉设备30的一部分,诸如工具50和/或工具夹持器51的圆柱部分。在一个实施例中,圆柱部分是工具夹持器51的夹持装置151的第一构件151a(图3A和图3B所示)。为了能让夹钳1500夹住该圆柱部分,第一部分1505可以具有V型槽(图6A所示),而第二部分1510可以具有平坦表面,以使得第一部分1505和第二部分1510在拧紧到一起时能够牢固容纳该圆柱部分。在一个实施例中,夹钳1500被配置为使得外科手术系统10能够在跟踪器47被放置在触觉设备30上的位置处确定触觉设备30的点和/或轴。例如,在用夹钳1500将跟踪器47固定至圆柱部分时,外科手术系统10就能够基于跟踪器47的几何结构,更具体地是阵列S4上的反射球和夹钳1500第一部分1505上的V型槽之间的几何关系,确定圆柱部分的点和/或轴(例如,图3B中所示的轴H-H)。
为了在触觉设备30上安装末端受动器跟踪器47,夹钳1500的第一部分1505和第二部分1510被放置在工具50或工具夹持器51的圆柱部分周围并用翼形螺钉1515拧紧在一起。受动器47可以包括被配置为辅助相对末端受动器35安置跟踪器47的特征部件(feature)。例如,跟踪器47可以包括一个或多个表面1503(如图6B所示),以适于紧靠触觉设备30上对应的表面。在一个实施例中,表面1503被配置为紧靠工具夹持器51的一部分,诸如图6B中所示的夹头151c的指状物或柄脚。操作中,用户沿着工具夹持器51的圆柱部分滑动夹钳1500直到表面1503紧靠夹头151c的指状物或柄脚并在随后拧紧翼形螺钉1515。跟踪器47可以通过松开翼形螺钉151并滑离圆柱部分来移除。以此方式,跟踪器47就能够可移除地且可重复地固定在相对末端受动器35的一已知位置。跟踪器47还可以包括诸如图6B中所示的凹坑(divot)47a的特征部件,以便于确定跟踪器47相对末端受动器35的方向,从而例如避免将跟踪器47装反。在安装跟踪器47之后,用户可以通过松开夹钳1500并绕着该圆柱部分旋转跟踪器47来(按需)重定向跟踪器47。于是,夹钳1500能够实现跟踪器47相对于末端受动器35的可调节性。可调节性在触觉设备配准校准(如下讨论)期间尤为有用,因为这就能够对跟踪器47进行定向使其面对检测设备41,藉此改善跟踪的精确性和可视性。
可选地,作为独立的末端受动器跟踪器47的替代,触觉设备30可以在末端受动器35上并入基准点(fiducials)。基准点可以类似于唯一的标示器阵列S4,并且可以包括例如反射球。与末端受动器跟踪器47相反的是,基准点在外科手术之前不从末端受动器35中移除。不移除基准点的一个劣势在于外科手术期间血液和碎屑可能会污染基准点,包括遮断基准点并降低它们向检测设备41反射光的能力。于是,基准点优选地包括光滑塑料涂层,从而能够轻易移除任何表面污染。基准点应该被安装在末端受动器35的某一位置上,该位置使得基准点在触觉设备配准校准(如下描述)期间对检测设备41可见,但不会在外科手术过程中妨碍外科医生。例如,基准点可以安装在末端受动器35的下侧。可选地,基准点可以安装在可调连接机构上,后者可以被安置在一配准校准位置上,其中在基准点和检测设备41之间存在部位亮线,以及一装载位置上,其中基准点将不会在外科手术过程中对外科医生有所阻碍。
在一个实施例中,末端受动器跟踪器47仅在触觉设备配准校准(如下描述)期间使用并且在执行外科手术过程之前就被移除。在此实施例中,末端受动器跟踪器47被置于末端受动器35上,而触觉设备跟踪器45则安装在基座32上(例如,经由可调臂34),使得触觉设备跟踪器45相对于触觉设备30的位置是可调节的。因为触觉设备跟踪器45的位置是可调节的,所以外科手术系统10不知道触觉设备跟踪器45相对于触觉设备30的位置。为了确定触觉设备30和触觉设备跟踪器45之间的几何关系,配准校准处理利用末端受动器跟踪器47(如下所述)。虽然末端受动器跟踪器47为了外科手术过程而保留在触觉设备30上并且能被持续监视,但是在完成配准校准时移除末端受动器跟踪器47是有利的,因为这就防止了跟踪器47在外科手术过程中对外科医生的妨碍。移除跟踪器47的另一好处在于跟踪器47在外科手术过程中的移动会导致因跟踪系统40检测并处理跟踪器47的移动而使带宽延迟或受限引起的外科手术系统10性能降低。
在一个可选实施例中,可以省去末端受动器跟踪器47。在此实施例中,触觉设备跟踪器45被永久固定在触觉设备30的一位置处。因为触觉设备跟踪器45被永久固定在触觉设备30上,所以触觉设备跟踪器45与触觉设备30的坐标框架之间的关系是已知的。因此,外科手术系统10不需要末端受动器跟踪器47来为配准校准建立触觉设备跟踪器45和触觉设备30的坐标框架之间的关系。在此实施例中,触觉设备跟踪器45可以刚性地安装在触觉设备30上满足下列要求的任何位置上,即允许跟踪系统40看见触觉设备跟踪器45的阵列S3,与外科手术部位足够接近从而不会降低精确性,并且不会在外科手术环境下妨碍用户干扰到其他人或对象。
在另一个可选实施例中,触觉设备30被稳稳地锁在原地。例如,触觉设备30可以闩在手术室的地板上或以其他方式固定在适当位置。结果使得触觉设备30的全局或总位置基本不会改变,这样外科手术系统10就不需要跟踪触觉设备30的全局或总位置。于是,就可以省去触觉设备跟踪器45。在此实施例中,末端受动器跟踪器47可用于在触觉设备30被锁定在适当位置之后确定该触觉设备30的初始位置。省去触觉设备跟踪器45的一个好处在于外科手术系统10不需要在控制回路中包括触觉设备跟踪器45的监视数据。结果就减轻了控制回路中的噪声和误差。作为替换,触觉设备跟踪器45可以被保留,但是仅仅为了监视基座32或跟踪系统40的过度动作,而不是被包括在控制回路内。
在另一个可选实施例中,跟踪系统40被永久地附至触觉设备30上的一固定位置处。例如,跟踪系统40(包括检测设备41)可以被直接安装在触觉设备30上或者经由刚性安装臂或悬臂连接至触觉设备30,以使得跟踪系统40的位置相对于触觉设备30固定。在此实施例中,可以省去触觉设备跟踪器45和末端受动器跟踪器47,因为跟踪系统40相对于触觉设备30的位置是固定的并且可以在执行校准过程中建立,例如在触觉设备30的生产或设置期间。
在另一个可选实施例中,跟踪系统40以一种可调方式附至触觉设备30。例如,跟踪系统40(包括检测设备41)可以用诸如可调臂34(在上文中结合触觉设备跟踪器45描述)的臂与触觉设备30连接,使得跟踪系统40可从相对于触觉设备30的第一位置移动至第二位置。在臂和跟踪系统40被锁定在适当位置之后,就能够执行校准来确定跟踪系统40相对于触觉设备30的位置。可以执行校准以确定跟踪系统40相对于触觉设备30的位置,例如通过用跟踪系统40查看末端受动器跟踪器47。
器械跟踪器49适于耦合至用户手持的器械150。器械150可以是例如探针,诸如配准探针。如图7所示,器械跟踪器49可以包括唯一的标示器(例如,反射球)阵列S5,该阵列可以与器械150集成形成或者以任何已知方式固定至器械150,诸如用机械硬件、黏合剂、焊接、螺纹连接、夹紧装置、夹子等来进行固定。当器械跟踪器49可移除地连接至器械150时,诸如用夹子或夹紧装置连接时,器械跟踪器49应该被校准至器械150以确定器械跟踪器49与器械150几何结构之间的关系。校准可以按任何合适方式实现,诸如用带有凹坑或V型槽的工具校准器进行(例如,在美国专利申请公开US 2003/0209096中描述的,其全文通过引用结合在此)。如果已知阵列S5和器械150之间的几何关系,外科手术系统10就能够计算器械150的尖端在物理空间中的位置。于是,器械150就能通过让器械150尖端碰触对象的相关部分而配准该对象。例如,器械150可以通过碰触患者骨表面上的界标或点来配准至骨。
跟踪系统40可以额外地或者可选地包括机械跟踪系统。与非机械跟踪系统(包括远离跟踪器43、45、47和49的检测设备41)相反的是,机械跟踪系统可被配置为包括物理连接至被跟踪对象的检测设备(例如,具有关节编码器的铰接的连接机构)。跟踪系统40可以包括任何已知的机械跟踪系统,诸如在其全文通过引用结合在此的美国专利6,033,415、美国专利6,322,567、和/或公开US 2006/0142657中描述的机械跟踪系统,或者可以包括光纤跟踪系统。
操作中,计算系统20、触觉设备30和跟踪系统40协作,使得外科手术系统10可以在外科手术过程中为用户提供触觉制导。触觉制导表明了用户与触觉描绘处理生成的虚拟环境的交互结果。触觉描绘处理可以包括任何合适的触觉描绘处理,诸如在美国专利6,111,577中描述的触觉描绘处理,该专利的全文通过引用结合在此。在一个较佳实施例中,触觉描绘处理包括在上文引用的于2006年12月27日提交的公开US 2006/0142657和/或美国专利申请序列号11/646,204中公开的触觉描绘算法,其全文通过引用结合在此。在该较佳实施例中,外科手术系统10利用基于点的触觉交互,在其中仅有虚拟点或者触觉交互点(HIP)与虚拟环境中的虚拟对象交互。HIP对应于触觉设备30上的物理点(physical point),诸如工具50的尖端。HIP通过虚拟弹簧/阻尼器模型与触觉设备30上的物理点相耦合。HIP与之交互的虚拟对象可以是例如具有表面707和触觉力法向矢量Fn的触觉对象705(如图11所示)。穿透深度di是HIP与表面707上最近点之间的距离。穿透深度di表示HIP穿透到触觉对象705中的深度。
触觉描绘处理的一个实施例在图10中一般性地表示。操作中,触觉设备30(框2500)的位置传感器(框2502)为正向运动学处理(forward kinematics process)(框2504)提供数据。正向运动学处理的输出被输入到坐标变换处理(框2506)。触觉描绘算法(框2508)接收来自坐标变换处理的输入并为力映射处理(框2510)提供输入。基于力映射处理的结果,触觉设备30的执行器(框2512)被激励以将合适的触觉旋量(wrench)(即,力和/或扭矩)传达给用户。
在一个实施例中,外科手术系统10包括如图12所示的触觉描绘处理。图12的虚线对应于图10的各框。如图12所示,坐标变换处理2506利用人体和触觉设备30的配准和跟踪信息以及来自正向运动学处理2504的输入来确定能让外科手术系统10计算触觉设备30的末端相对于人体具体部位的位置的坐标变换(或变形)。例如,坐标变换处理2506能让外科手术系统10计算工具50的尖端相对于人体上期望切割表面的位置。
如图13所示,坐标变换处理2506包括定义各种坐标系,包括与跟踪系统40的检测设备41相关联的第一坐标系X1、与人体(例如,骨或者固定在骨上的人体跟踪器43a或43b)相关联的第二坐标系X2、与触觉设备跟踪器45相关联的第三坐标系X3、与触觉设备30(例如,触觉设备的基座32)相关联的第四坐标系X4、以及与虚拟环境(例如,包括了定义用于植入物安装的期望切割表面的虚拟(或者触觉)对象的人体表示)相关联的第五坐标系X5。坐标变换随后被确定以使得一个坐标系中的坐标被映射至或变换至另一个坐标系。
第一坐标转换T1(如图12和13所示)是从人体坐标系(第二坐标系X2)到虚拟环境坐标系(第五坐标系X5)的变换。于是,在其中虚拟环境包括定义了植入物形状的虚拟对象的实施例中,变换T1将物理人体与用于植入物安装的期望切割定位相联系。如图12中的框4500所表示的,变换T1可以通过将患者的物理人体与该人体的表示(如下描述)相配准并相对于该人体表示安置虚拟对象来确定。相对于该人体表示安置虚拟对象可以通过例如使用任何合适的方案制定处理来实现,诸如在上文引用的公开US 2006/0142657中所公开的植入物方案制定处理。例如,定义虚拟切割边界的虚拟模型(诸如,要植入骨中的植入物的模型)可以相对于在显示设备23上显示的人体表示(诸如,人体图像)来安置。
第二坐标变换T2(如图12和13所示)是从检测设备41坐标系(坐标系X1)到人体坐标系(坐标系X2)的变换。如图12中由框4502表示的,跟踪系统40在手术过程中随着检测设备41对人体运动的监视而输出该变换T2。因为检测设备41持续监视人体,所以该变换T2被规律性地更新以反映人体的运动。
第三坐标变换T3(如图12和13所示)是从触觉设备跟踪器45坐标系(坐标系X3)到触觉设备30坐标系(坐标系X4)的变换。在此实施例中,触觉设备跟踪器45经由臂34耦合至触觉设备30的基座32(如图2A所示)。于是,变换T3就将触觉设备跟踪器45的定位与触觉设备30的基座32相联系。如图12中的框4504所表示的,变换T3可以例如通过执行如下所述的触觉设备配准校准来确定。
第四坐标变换T4(如图12和13所示)是从检测设备41坐标系(坐标系X1)到触觉设备跟踪器45坐标系(坐标系X3)的变换。如图12中由框4506表示的,跟踪系统40在外科手术过程中随着检测设备41对触觉设备跟踪器45运动的监视而输出该变换T4。因为检测设备41持续监视触觉设备跟踪器45,所以该变换T4被规律性地更新以反映触觉设备跟踪器45的运动。
第五坐标变换T5(如图12和13所示)是由正向运动学处理2504产生的变换。正向运动学处理2504将触觉设备30的臂33的笛卡尔末端位置计算为关节角度的函数。如图12中由框4508和4510表示的,正向运动学处理2504接收来自臂33各关节处的位置传感器的输入。基于这一输入,正向运动学处理2504计算臂33的远端相对于触觉设备30基座32的位置。基于工具50和臂33远端之间的已知几何关系,于是就能够算出工具50的尖端相对于触觉设备30的基座32的位置。因为位置传感器持续监视关节位置,所以该变换T5被规律性地更新以反映臂33的运动。
第六坐标变换T6(如图12和13所示)通过将第一至第五坐标变换以适当序列乘到一起获得。在一个实施例中,T6=T1 -1T2 -1T4T3 -1T5。变换T6的结果(由图12中的变量x表示)是虚拟点或触觉交互点(HIP)相对于虚拟环境的定位。在此实施例中,HIP对应于触觉设备30上的物理点(例如,工具50的尖端)相对于由虚拟对象定义的期望切割表面的定位。因为人体、触觉设备跟踪器45、以及触觉设备30的臂33的运动被持续监视,所以转换T6被规律性地更新以反映人体、触觉设备30的基座32、以及触觉设备30的臂33的运动。以此方式,外科手术系统10就能够补偿外科手术过程中各对象的运动。
本发明的一个好处在于外科手术系统10能够以对用户透明的动态方式补偿外科手术过程中各对象的运动。更具体地,外科手术系统10通过持续监视人体、触觉设备跟踪器45、以及臂33的运动并持续更新变换T2、T4和T5,就能够进行同步操作而无需打断触觉设备30的操作。与之相反,常规的外科手术系统通常为异步操作,例如在检测到被跟踪对象移动时通过要求用户停止并重置系统或重新配准被跟踪对象来操作。结果是,对于常规系统而言,系统的操作会在检测到被跟踪对象的运动时被打断或阻碍。虽然本发明能够进行同步操作而无需打断触觉设备30的操作,但是不时地对触觉设备30的操作进行限制仍是有利的,例如在外科手术系统10检测到异常运动的情况下,诸如在被跟踪对象移动太快和/或太远时。
在一个实施例中,一种在外科手术过程中补偿对象移动的方法包括:(a)确定人体的姿态;(b)确定工具50的姿态;(c)确定工具50的位置、方向、速度和加速度中的至少一个;(d)将人体的姿态、工具50的姿态、以及该人体姿态与该工具50的位置、方向、速度和加速度中的至少一个之间的关系相关联;以及(c)响应于人体的运动和/或工具50的运动更新上述关联,而无需在外科手术过程中打断手术设备的操作。本方法还包括基于上述关系向用户提供触觉制导以约束用户对手术工具的操纵。该关系可以基于例如人体和工具50的位置、方向、速度和/或加速度之间的期望交互。在一个实施例中,该关系由相对于人体安置并表示植入物和/或切割表面的期望定位以供植入物安装的虚拟对象或参数来定义。将人体的姿态、工具50的姿态、以及该关系相关联的步骤例如可以使用配准处理、坐标变换处理(例如,图10的框2506)和植入方案制定处理(例如,如上文引用的公开US 2006/0142657中所描述的)来实现。在一个实施例中,该关联步骤包括:(a)定义将人体坐标系变换成人体表示坐标系的第一变换;(b)定义将工具50坐标系变换成人体表示坐标系的第二变换;以及(c)将该关系与该人体表示的坐标系相关联。为了将该关系与该人体表示的坐标系相关联,用户可以例如相对于人体图像来安置虚拟对象(例如,如上文引用的公开US 2006/0142657中所描述的)。为了能让外科手术系统10在外科手术过程中对各对象的运动进行补偿,更新上述关联的步骤可以包括响应于人体的运动和/或工具50的运动更新第一变换和/或第二变换。
在此实施例中,对工具50姿态的确定是通过确定耦合至该工具50的触觉设备30的第一部分的姿态,确定触觉设备30的第二部分的姿态,并且至少部分基于触觉设备30第一和第二部分的姿态以及工具50和触觉设备30第一部分之间的已知几何关系来计算工具50的姿态来实现的。在一个实施例中,触觉设备30的第一部分包括臂33的远端,而触觉设备30的第二部分则包括触觉设备30的基座32。在另一个实施例中,触觉设备30的第二部分包括臂33的中间部分(例如,段33a、33b或33c)。在一个实施例中,并非将末端受动器跟踪器35安装至臂的远端,末端受动器跟踪器35可以被安装至臂的中间部分,诸如肘部。确定触觉设备30第二部分的姿态的步骤包括确定触觉设备跟踪器45(安装在触觉设备30的第二部分上,例如基座32或臂33的中间部分)的姿态。因为工具50的姿态是基于触觉设备30的第一和第二部分的姿态来确定的并且因为外科手术系统10持续更新该第一和第二部分(例如,基于关节编码器数据和触觉设备跟踪器45的位置),工具50姿态的更新顾及了第一和第二部分的运动。结果就能基于第一和第二部分的运动确定工具50的运动。以此方式,外科手术系统10就能够补偿外科手术过程中各对象的运动。
在一个实施例中,跟踪系统40是以不同于触觉设备30的更新速率进行操作的非机械跟踪系统(例如,如在上文中结合跟踪系统40描述的)。例如,触觉设备30可以按2000Hz的速率更新,而跟踪系统40可以按15-30Hz的速率更新。跟踪系统40较低的更新速率限制了运动补偿的动态性能,因为15-30Hz的更新就意味着在1/15至1/30秒期间是没有跟踪信息可用的。另外,被跟踪对象的更高频率运动将不会在跟踪系统40的输出数据中呈现。较差动态性能的一个缺点在于外科手术系统10可能不具有足够的数据来与物理人体同步地精确移动触觉对象。结果会使得外科医生做出的任何切割的精确度降低。例如,当外科手术系统10提供触觉制导来指导外科医生用球形钻头切割平坦的骨表面时,被跟踪对象之一的瞬时运动在加上较差的动态性能会导致最终切割表面上的凹坑和突起。动态性能越差,凹坑和突起就越大。如果骨切割是为了粘接植入物,那么较小的凹坑是可接受的,因为粘固剂将会简单填充各凹坑。然而对于压配植入物,凹坑会导致植入物和骨之间的间隙,这可能会抑制骨充分长入植入物。突起因其可由钻头轻易去除,所以没有凹坑那么严重,但会增加完成骨制备所需的时间量。
对于运动补偿应用,几种技术有益于让有动态性能问题的跟踪系统其性能实现最大化。首先,因为不同的更新速率,如果坐标变换处理2506使用直接来自跟踪系统40的数据,则由虚拟对象定义的期望切割表面将响应于检测到的人体运动而以突变步长运动。结果使得操纵触觉设备30的用户在与触觉对象交互时可能会体验到剧烈的或“跳跃性的”感受。为了解决这一问题,外科手术系统10可以包括内插或其他合适滤波器(在图12中由框4512表示)。滤波器还用于降低跟踪系统的输出噪声,该噪声否则会导致用户在与触觉对象交互时感到振动,或导致切割出粗糙表面。在一个较佳实施例中,滤波器是截止频率范围在5-10Hz之间的三阶Butterworth(巴特沃思)滤波器,它以2000Hz的频率采样来自跟踪系统40的数据并生成经滤波的输出。经滤波的输出减轻了跟踪系统的“阶梯式”输出以及跟踪系统输出更新中固有噪声的影响,从而降低了切割表面相对于人体的“跳跃性”。Butterworth滤波器以通带平坦频率为特征,并且用常见滤波器设计软件可以很容易设计,诸如用Mathwork的Matlab Signal ProcessingToolbox(Matlab信号处理工具栏)的“butter”功能来设计,从而基于期望的阶数和截止频率输出数字或模拟滤波器系数。使用更高的阶数会获得更陡的滚降特性,但需要额外的计算。较低的截止频率会改善对离散跟踪系统更新和跟踪系统噪声的滤波,但是会降低跟踪的动态性能。可选地,Chebychev(切比雪夫)滤波器、Inverse Chebychev(逆切比雪夫)滤波器、Elliptic(椭圆)滤波器、Bessel(Thomson)(贝塞尔(汤姆森))滤波器、或者其他滤波器可用于代替Butterworth滤波器。在另一个实施例中,可以使用有限脉冲响应(FIR)滤波器。FIR滤波器可被设计为“线性相位”,使得所有频率都被延迟相同的量,从而使得对滤波器延迟的补偿更为容易。FIR滤波器还很好地适合于“多速率”应用。对于本发明的跟踪应用,内插法可用于将低频跟踪信号转换成触觉设备30的高频速率。FIR滤波器在多速率应用中要优于无限脉冲响应(IIR)滤波器,因为FIR滤波器没有反馈,即其输出仅仅是滤波器输入信号的函数,而不是输出信号的函数。同样地,仅要求对低频信号采样做出计算,而不要求对每个高频采样做出计算。
在它们的传统实现中,上述滤波器全部为标量输入信号而设计。然而,跟踪系统40一般会生成输出多个位置和方向信号。在一个较佳实施例中,滤波器4512接收跟踪系统的输出,将其表达为包含位置和方向信息的齐次变换四乘四矩阵。并不希望直接对该矩阵的各元素进行滤波,因为其结果将不会是一个有效的齐次矩阵并且其方向将无法适当滤波。作为替代,齐次变换首先被转化为一个三元素位置矢量和一个四元数,其中四元数是表示方向信息的一个含有四个元素的矢量。对于各采样间的较小运动,这七个值随后可被独立滤波。四元数可以在获取经滤波的值并将其转换回齐次变换之前归一化,而转换回的齐次变换随后从滤波器4512输出。
在大多数情况下,跟踪系统40的位置输出表示在过去某一点处相关的被跟踪对象的位置。等待时间是跟踪系统40采样被跟踪对象位置的时刻与外科手术系统10接收到该位置输出的时刻之间的时间间隔。这一时间间隔可以包括跟踪系统40的处理时间,通信延迟,以及跟踪系统40采样时间的几分之一或几倍。滤波器4512基于所选用的特定滤波器的相位延迟添加额外的等待时间。这些等待时间源全部结合,会降低动态跟踪性能并使得触觉表面滞后于其关联的被跟踪对象的运动。然而,这些等待时间的值通常是已知的,并且可被测量或相当精确地估计。于是,等待时间效应可以被部分补偿。例如,如果跟踪系统40和滤波器4512的组合等待时间是tl,则经滤波的位置输出p可以被校正为Δp=vtl。速度值v可以通过(可能经滤波的)连续位置值之差来计算,或者如下所述通过冲失(washout)滤波器来计算。在另一个实施例中,正如控制论领域技术人员所周知的,状态估计器、状态观测器、或者Kalman(卡尔曼)滤波器包括人体和/或触觉设备30基座32的简单仿真模型,在其内部计算被跟踪对象的位置和速度两者,从而可用于省去滤波器4512的等待时间。可选地,通过利用高频跟踪系统,诸如基于编码器的机械跟踪系统或者高速光学跟踪系统,就可以省去滤波器4512。
一些跟踪系统,尤其是光学跟踪系统,在被跟踪对象相对于照相机(即,检测设备41)移动时可能无法产生精确输出。误差就可能例如由照相机的曝光时间或扫描速率引起的运动模糊而产生。如果被跟踪对象的速度是使用上述方法之一计算并且作为速度和/或位置的函数的跟踪系统误差模型是已知的或者是确定的,那么这些误差就可以通过将这一误差值与经滤波的位置输出相加来校正。
跟踪系统40的动态性能仅在触觉设备30能够有效描绘运动中的触觉对象的情况下才是相关的。触觉设备30的触觉描绘能力受到所使用的触觉控制方案的影响。触觉设备30可以利用任何合适的触觉控制方案,诸如导纳控制、阻抗控制或混合控制。在导纳控制模式中,触觉设备30接受力输入并产生位置(或者运动)输出。例如,触觉设备30测量或感测该触觉设备30一特定位置处(例如,用户接口37)的旋量,并对该触觉设备30的位置进行修改。在阻抗控制模式中,触觉设备30接受位置(或者运动)输入并产生旋量输出。例如,触觉设备30测量、感测和/或计算工具50的位置(即,位置、方向、速度和/或加速度)并施加适当的对应旋量。在混合控制模式下,触觉设备30利用导纳和阻抗控制两者。例如,可以将触觉设备30的工作空间分割成其中使用导纳控制的第一子空间以及其中使用阻抗控制的第二子空间,和/或位置和力输入都可用于计算力或位置输出。例如,在实质上由阻抗控制的设备中,力输入可用于抵消控制系统的部分固有摩擦力。在一个较佳实施例中,触觉设备30被设计为阻抗控制,其中该触觉设备30读取用户操纵的外科手术工具50的位置和/或方向并输出恰当的力和/或扭矩。阻抗控制设备具有以下优点:简单化(不需要力传感器)、在工具接触物理对象时(诸如切割骨时)更高的稳定性特性、以及在自由空间中移动时更好的性能。然而,导纳控制设备的优点则在于它们相比于阻抗控制设备,能够更容易地用极硬墙描绘触觉对象。对于运动跟踪,阻抗控制设备的优势在于其性能与开环力带宽和物理系统动力学有关。相比之下,导纳控制设备的性能则依赖于闭环位置控制性能,而后者趋向于比开环力和物理系统动力学更为缓慢。
返回到图10的触觉描绘算法,提供由坐标变换处理2506确定的HIP定位x作为如图12所示对触觉描绘算法2508的输入。碰撞检测/代理定位触觉描绘处理(由图12中的框2514表示)接收HIP定位x作为输入并输出期望定位xd。从期望定位xd中减去HIP定位x,并将结果Δx与触觉刚度Kp相乘,以确定依赖于位置的力指令F弹簧。期望速度也可以通过取得期望定位xd的导数来确定。期望速度用于计算阻尼力F阻尼。
如图12所示,阻尼力F阻尼通过从触觉设备30的笛卡尔末端速度中减去期望速度并将其结果与阻尼增益KD相乘而算出。笛卡尔末端速度使用来自臂33电机的位置传感器的数据来计算。如上结合触觉设备30所述,触觉设备30的臂33较佳地在臂33的电机和关节中包括线缆传动机构和位置传感器。在一个较佳实施例中,关节编码器(由图12中的框4508表示)用于获取关节位置度量,而电机编码器(由图12中的框4516表示)则用于获取速度度量。关节位置度量在正向运动学处理2504中用于确定变换T5,并且还被提供作为对重力补偿算法(由图12中的框4518表示)的输入。重力补偿算法计算作为关节角度的函数且用于抵消臂33各段重力负载所需的重力扭矩τ重力_补偿。与之相反,电机位置度量则被差分并滤波以计算电机速度度量。冲失滤波器(如图12中的框4520所示)将微分和平滑组合到一个滤波器中。冲失滤波器可以在拉普拉斯域中表示为:
其中是s拉普拉斯变换变量,而p则确定了各极点的定位并且通常应该被定位在比最远系统极点还要再远约两至三倍的地方。在一个实施例中,极点被置于约80Hz处。经滤波的速度随后与雅可比矩阵J相乘,由此获得触觉设备30的笛卡尔末端速度。
冲失滤波器限制高频增益,藉此限制求导或微分运算中固有噪声的放大同时移除采样频率伪像。冲失滤波器具有单参数p,后者相比于分别进行的速度微分和平滑运算,简化了滤波器的设计和调谐。以上给出的拉普拉斯域表示能够被变换成适于使用已知双线性变换或z变换在数字计算机上实现的离散时间表示。在冲失滤波器的可选实施例中,简单差分的位置信号可由Butterworth或其他上文描述的滤波器滤波以提供速度测量。可选地,经滤波的位置信号可以被差分并可能用上文描述的任何滤波器被再次滤波。
如图12所示,在力映射处理2510中求和F阻尼和F弹簧以获取期望的触觉力F触觉。期望的触觉力与转置雅可比矩阵JT相乘,以计算生成期望触觉力所需的电机扭矩τ触觉。重力扭矩τ重力_补偿与电机扭矩τ触觉相加以获得总扭矩τ总。触觉设备30被指令向臂33的电机施加总扭矩τ总。以此方式,触觉描绘处理使得外科手术系统10能够控制触觉设备30,后者随后响应指令的扭矩、用户交互并与人体交互。
触觉设备30优选地被配置为在各种操作模式下操作。例如,触觉设备30可以被编程在输入模式、保持模式、安全模式、自由模式、接近模式、触觉(或钻动(burring))模式和/或任何其他合适的模式下操作。操作模式可由用户手动选择(例如,使用在显示设备23上图形表示的选择按钮或者位于触觉设备30和/或计算系统20上的模式开关)和/或由控制器或软件处理自动选择。在输入模式下,触觉设备30可用作向外科手术系统10输入信息的输入设备。当触觉设备30处于输入模式时,用户可以将触觉设备30作为操纵杆或其他输入设备操作,这些输入设备可以如上所述结合末端受动器35使用和/或在美国专利申请序列号10/384,078(公开US 2004/0034282)中有所描述,其全文通过引用结合在此。
在保持模式中,触觉设备30的臂33可以被锁定在一特定姿态上。例如,臂33可以使用制动器、控制伺服技术和/或任何其他用来稳定臂33的硬件和/或软件技术来锁定。用户例如在诸如骨切割至休息、与同事协商、允许对外科手术部位的清洁和冲洗之类的活动期间期望让触觉设备30处于保持模式。在安全模式下,耦合至触觉设备30的工具50例如可以通过关断工具50的电源来禁用。在一个实施例中,安全模式和保持模式可以被同时执行,从而在将触觉设备30的臂33锁定在原地的同时禁用工具50。
在自由模式中,触觉设备30的末端受动器35在触觉设备30的工作空间内可自由移动。优选不对工具50供电,并且适于让用户感觉不到触觉设备30的重量。无重量感的实现例如可以通过计算作用于臂33的段33a、33b和33c的重力负载并控制触觉设备30的电机以抵消该重力负载(例如,以上结合图12的框4518所描述的)。结果用户就无须支撑臂的重量。触觉设备30例如可以处于自由模式,直到用户准备好将工具50导向患者人体的外科手术部位。
在接近模式中,触觉设备30被配置为将工具50引导至目标对象,例如外科手术部位、所关注的患者人体特征、和/或配准至患者的触觉对象,同时避开关键结构和人体。例如,在一个实施例中,接近模式能够进行工具50的交互触觉安置,这在美国专利申请序列号10/384,194(公开US 2004/0034283)中有所描述,其全文通过引用结合在此。在另一个实施例中,触觉描绘应用可以包括定义了接近体积(或边界)的触觉对象,上述接近体积(approach volume,或边界)对工具50进行约束以使其朝向目标对象移动同时避免诸如血管、腱、神经、软组织、骨、现有植入物之类的敏感特征部位。例如,如图1所示,接近体积可以包括触觉对象300,后者基本上呈圆锥形,朝向目标对象(例如,胫骨T的近端或者股骨F的远端)直径呈漏斗状减小。操作中,用户可以在接近体积的边界内自由移动工具50。然而随着用户移动工具50通过该接近体积,这一漏斗形状约束工具的移动,使得工具50不会穿透该接近体积的边界。以此方式,工具50被直接引导至外科手术部位。
接近模式的另一个实施例如图8所示,图8示出了对应于人工膝关节股骨部件的触觉对象208,以及对应于人工膝关节胫骨部件的触觉对象208。在这一实施例中,触觉描绘应用创建了表示从第一位置到第二位置的路径的虚拟对象。例如,虚拟对象可以包括触觉对象310,而后者是定义从第一位置(例如,工具50在物理空间中的位置)到包括目标(例如,诸如触觉对象206或208的目标对象)的第二位置的路径的虚拟导丝(guide wire)(例如,线)。在接近模式下,触觉对象310被激活使得工具50的移动被约束为沿着由该触觉对象310定义的路径进行。外科手术系统10在工具50到达第二位置时去激活触觉对象310并激活目标对象(例如,触觉对象206或208)。工具50可以在触觉对象206或208被激活时自动置于触觉(或钻动)模式下。在一个较佳实施例中,可以去激活该触觉对象310以使得工具50能够脱离该路径。于是,用户能够忽略与触觉对象310相关联的触觉制导,从而能够脱离导丝路径并操纵工具50围绕在生成虚拟导丝时无法顾及的非跟踪对象(例如,牵引器、灯等)工作。于是,该接近模式使得用户能够将工具50快速送至目标对象,同时避开关键结构和人体。在接近模式下,优选不对工具50供电,使得工具不会被意外通电,例如当用户将工具插入切口或在关节的软组织内导航的时候。该接近模式通常优于触觉模式。
在触觉(或钻动)模式中,触觉设备30被配置为在诸如骨制备的外科手术活动中向用户提供触觉制导。在一个实施例中,如图8所示,触觉描绘应用可以包括定义了胫骨T上切割体积的触觉对象206。触觉对象206可以具有与胫骨部件表面形状基本上对应的形状。触觉设备30可以自动进入触觉模式,例如在工具50的尖端接近与所关注特征部位相关的预定义点时。在触觉模式下,触觉对象206还可以被动态修改(例如,通过启用和禁用触觉表面的各部分)以改善触觉设备30在雕刻复杂形状或大曲率形状时的性能,例如在美国专利申请序列号10/384,194(公开US 2004/0034283)中描述的,其全文通过引用结合在此。在触觉模式下,可以启动对工具50的供电,并且将工具50的尖端限制在切割体积内以实现精确的骨切除。在另一个实施例中,例如可以通过在用户接近触觉体积的情况下生成缓慢增加的力将用户拉入触觉体积来实现方向约束。另外,在这一实施例中,只要工具50位于触觉体积之外就禁用工具50。在另一个实施例中,工具50可以被禁用直到触觉设备30生成触觉反馈力。
操作中,外科手术系统10可用于如上引用的公开US2006/0142657所公开的外科手术方案制定和导航。外科手术系统10例如可用于执行涉及植入物安装的膝关节置换过程或其他关节置换过程。植入物可以包括任何植入物或人工器官(prosthetic device),诸如全膝关节植入物;单踝膝关节植入物;模块式膝关节植入物;用于包括髋关节、肩关节、肘关节、腕关节、踝关节和脊柱在内的其他关节植入物;和/或任何其他整形外科和/或肌骨植入物,包括常规材料植入物和新材料植入物,诸如骨生物活性材料(orthobiologics)、药物释放植入物、以及细胞传递植入物。在执行该过程之前,对触觉设备30进行初始化,包括自引导处理(homing process)、运动学校准、以及触觉设备配准校准。
自引导处理初始化臂33内的位置传感器(例如,编码器)以确定臂33的初始姿态。自引导可以按任何已知的方式完成,诸如通过操作臂33以使得每个关节编码器旋转直到编码器上的索引标记被读取。索引标记是与关节的已知绝对位置互相关的对该编码器的绝对参考。于是,一旦读取了索引标记,触觉设备30的控制系统就知晓关节的绝对位置。随着臂33的持续移动,可以基于编码器的绝对位置或后续位移来计算该关节的后续位置。
运动学校准标识正向运动学处理2504(图10所示)的运动学参数中的误差。正向运动学处理2504基于臂33的测得关节角度以及触觉设备30的设计几何属性(例如,臂33的段33a、33b和33c的长度和偏移量)来计算末端受动器35的笛卡尔位置和方向。然而由于制造不精密,触觉设备30的实际几何属性可能偏离设计的几何属性,从而导致正向运动学处理2504输出中的误差。为了确定该误差,运动学校准固定器附连至触觉设备30。在一个实施例中,固定器是一种具有固定已知长度的校准棒。为了执行运动学校准,用具有一个或多个球窝关节(例如,排列形成十字的四球窝关节,其中该十字的每个末端放置一个球窝关节)的校准末端受动器来代替末端受动器35,移除臂34(其上安装有触觉设备跟踪器45)并在水平配准中重新安装。校准棒的第一端与臂34上的球窝关节磁性啮合,该校准棒的第二端则与校准末端受动器上的一个球窝关节磁性啮合。校准末端受动器于是在外科手术系统10捕捉数据时被(手动地或者自动地)移至多个位置。在收集了足够多的数据(例如,100个数据点)之后,校准棒的第二端就与校准末端受动器上的一个不同的球窝关节磁性啮合。重复这一处理直到为校准末端受动器上的每个球窝关节都捕捉了数据。使用现有的运动学参数和测得的关节角度,就可以使用该数据来计算校准棒的长度。算出的校准棒长度与已知的实际长度相比较。算出长度和已知长度之差就是误差。一旦误差确定,就使用例如Levenberg-Marquardt的数值非线性算法调节运动学参数以最小化正向运动学处理2504中的累积误差。
触觉设备配准校准建立起触觉设备跟踪器45坐标系(例如,图13中示出的坐标系X3)和触觉设备30坐标系(例如,图13中示出的坐标系X4)之间的几何关系或变换。如果触觉设备跟踪器45被永久固定在触觉设备30上的某一位置上,那么配准校准就不是必须的,因为跟踪器45和触觉设备30之间的几何关系是固定且已知的(例如,得自制造或设置期间执行的初始校准)。与之相反,如果跟踪器45能够相对于触觉设备30移动(例如,如果其上安装了跟踪器45的臂34是可调的),那么就必须执行配准校准以确定跟踪器45和触觉设备30之间的几何关系。
配准校准涉及将触觉设备跟踪器45牢固固定到触觉设备30的一位置上并暂时将末端受动器跟踪器47附于末端受动器35,例如用图6A所示的夹具1500。为了将触觉设备跟踪器45配准至触觉设备30,末端受动器35(以及末端受动器跟踪器47)移动至人体附近的各个位置(例如,膝关节上下的各位置、膝关节内侧和横向的各位置),同时跟踪系统40在每个位置处获取跟踪器45和47相对于跟踪系统40的姿态数据。收集并平均多个数据点以使得传感器噪声和其他度量误差的影响最小。配准校准期间姿态收集的获取可以是自动进行的。可选地,用户可以使用诸如脚踏板的输入设备来启动数据收集。
在一个实施例中,用户将末端受动器35手动移至各个位置,同时末端受动器35处于自由模式。在另一个实施例中,外科手术系统10包括触觉设备30用于将末端受动器35自动移至各个位置。在又一个实施例中,触觉设备30提供触觉制导,从而为用户在触觉设备30的工作空间中将末端受动器35移至预定义点提供引导。为了改善配准校准的精确性,预定义点较佳地位于外科手术部位附近(例如,接近实际的骨制备部位)。预定义点可以包括例如一形状的各顶点,诸如两维或三维多面体(例如,多边形或多面体)的各顶点。在一个实施例中,该形状是以诸如膝关节的相关人体为中心的立方体。各顶点在显示设备23中较佳地沿着指示末端受动器35允许移动方向的箭头显示。利用触觉制导来引导用户将末端受动器35移至预定义点的一个优势在于用户能够以可重复的方式将末端受动器35移至多个位置,从而改善配准校准的精确性。
除了捕捉与跟踪器45和47相对于跟踪系统40的姿态有关的数据,外科手术系统10还基于来自臂33内位置传感器(例如,关节编码器)的数据确定末端受动器35相对于触觉设备30的姿态。外科手术系统10使用在配准校准期间获取的数据来计算触觉设备跟踪器45和触觉设备30参考坐标框架(例如,图54中示出的坐标系X4)之间的几何关系。
在一个实施例中,相对于触觉设备30基座32的触觉设备跟踪器45的变换如下计算。随着末端受动器35移至各个位置,外科手术系统10记录(a)末端受动器跟踪器47相对于跟踪系统40的位置(例如,末端受动器35上一已知位置),该位置可以从跟踪系统40获得;(b)触觉设备跟踪器45相对于跟踪系统40的位置和方向,该位置和方向可以从跟踪系统40获得;以及(c)末端受动器跟踪器47相对于触觉设备30基座的位置r,该位置可以从触觉设备30的关节编码器获得。如果在跟踪系统输出中有噪声出现,那么可以为每个末端受动器位置获取多个采样。在触觉设备30在数据采样期间移动的情况下,外科手术系统10会警告用户。此外,任何受影响的数据点都应丢弃,因为在来自跟踪系统40的数据和来自触觉设备30的关节编码器的数据之间存在等待时间。对于每个测试定位i,用 计算末端受动器跟踪器47相对于触觉设备跟踪器45的位置。在每个测试定位i处,末端受动器跟踪器47相对于触觉设备30基座32的位置由ri表示。
在数据收集完成之后,触觉设备跟踪器45相对于触觉设备30基座32的变换被分成方向和位置项 方向分量通过求解方程 得出。对于此方程,根据 和 计算位置误差矢量和其中 和 使用单值分解的最小平方估计器来求解位置矢量于是可从方程 得出。触觉设备跟踪器45相对于触觉设备30基座32的变换于是就可根据 重构。
在配准校准完成之后,从触觉设备30中移除末端受动器跟踪器47。外科手术期间,外科手术系统10基于以下各项确定工具50的姿态:(a)工具50和末端受动器35之间的已知几何关系;(b)末端受动器35相对于触觉设备30的姿态(例如,从臂33的位置传感器确定);(c)在配准校准期间确定的触觉设备30和触觉设备跟踪器45的几何关系;以及(d)触觉设备30的全局或总位置(例如,从触觉设备跟踪器45相对于跟踪系统40的姿态确定)。如果触觉设备跟踪器45相对于触觉设备30没有移动,就无须执行配准校准,因为先前的配准校准和在前获取的配准校准数据仍然是可靠的。
在一个实施例中,一种用于执行配准校准的方法包括(a)获取第一数据,该第一数据包括放置在触觉设备30上的第一定位处的第一对象的位置和方向中的至少一个;(b)获取第二数据,该第二数据包括放置在触觉设备30上的第二定位处的第二对象的位置和方向中的至少一个;(c)确定第三数据,该第三数据包括第一对象相对于第二定位的位置和方向中的至少一个;以及(d)至少部分基于第一数据、第二数据和第三数据确定第二对象相对于第二定位的位置和方向中的至少一个。该方法还可以包括(e)将第一对象(例如,放置在触觉设备30的臂33上的末端受动器跟踪器47)移至多个位置;(f)提供触觉制导(例如,力反馈)来引导用户将第一对象移至多个位置中的至少一个;(g)在第一对象处于多个位置中的每个位置时获取第一数据或第二数据;以及(h)如果第一对象、第二对象、第一定位和/或第二定位在第一数据、第二数据和/或第三数据获取期间移动,则警告该用户。
在一个实施例中,第一对象是末端受动器跟踪器47,并且第二对象是触觉设备跟踪器45。在这一实施例中,获取第一数据和第二数据的步骤包括用检测设备41检测跟踪器45和47。可选地,第二对象包括跟踪系统40的一个或多个组件,诸如检测设备41。如上结合末端受动器跟踪器47所述,末端受动器跟踪器47可以被放置在触觉设备30上一个包括诸如工具50或工具夹持器51的圆柱特征部件的定位特征部件的定位处(例如,第一定位处)。在此情况下,获取第一数据的步骤包括确定该圆柱特征部件的点和/或轴(例如,图3B中所示的轴H-H或其上任何点)的位置和/或方向。如上结合触觉设备跟踪器45所述,触觉设备跟踪器45(或检测设备41)可被放置在触觉设备30上的特定位置处(例如,第二位置),诸如(例如,经由臂34)其上放置臂33近端的基座32。可选地,触觉设备跟踪器45(或末端受动器跟踪器47)可以位于臂33的中间部分上。在触觉设备配准校准期间,第一对象和第二对象的位置和/或方向可以分别相对于第一定位和第二定位被固定。固定例如可以通过用夹具1500将末端受动器跟踪器47夹住末端受动器35上或者通过固定其上安装有触觉设备跟踪器47(或检测设备41)的臂34的位置来实现。为了确定第一对象相对于第二定位的位置和方向(即,第三数据),外科手术系统10例如基于来自关节编码器的数据确定臂33的配置。
在初始化触觉设备30之后,外科医生能够将患者和外科手术工具50与人体的表示(诸如,CT图像)相配准,并执行外科手术过程,诸如基于外科手术方案制备容纳植入物的骨。配准、植入方案制定和外科手术导航可以如上引用的公开US 2006/0142657中所描述的来实现。贯穿该外科手术过程,外科手术系统10监视骨的位置以检测骨的移动并对在计算机21和/或计算机31上运行的程序作出相应的调节。例如,外科手术系统10能够响应于检测到的骨移动调节骨的表示(或图像)。类似的,外科手术系统10能够响应于检测到的手术工具50的移动来调节手术工具50的表示(或图像)。于是,骨和外科手术工具在显示设备23上的图像就随着骨和外科手术工具50在物理空间中的移动而实时动态移动。外科手术系统10还响应于检测到的骨移动调节与骨相关联的虚拟对象。例如,虚拟对象可以定义对应于植入物表面形状的虚拟切割边界。随着骨的移动,外科手术系统10调节虚拟对象以使得该虚拟切割边界对应于身体骨而移动。以此方式,外科医生即便在骨正移动的情况下也能够完成精确的骨切割。此外,图像和触觉对象的调节对外科医生是透明的,从而不会在外科手术期间打断外科医生对触觉设备30的操作。
为了改善外科手术系统10的安全性,外科手术系统10可以包括适于在不安全条件存在时约束用户对工具50进行操作的安全特征部件。例如,如果检测到不安全条件,外科手术系统10可以发出故障信号。故障条件会在下列情况中存在:存在系统问题(例如,硬件或软件的问题);遮断检测算法(例如,如下描述)检测到遮断条件;被跟踪对象移动过快使得跟踪系统无法处理(例如,当患者的腿或触觉设备跟踪器45突然下落时);当跟踪数据有问题时;当用户按压接口37太用力时;和/或工具50处于不期望的定位时。在一个实施例中,外科手术系统10被编程为在下列情况下发出故障:人体和工具50的位置、方向、速度和/或加速度之间的关系没有与期望关系相对应;和/或检测设备41无法检测人体的位置或手术工具50的位置。响应于故障信号,外科手术系统10可以对触觉设备30加以约束。约束可以包括例如向用户提供触觉制导(例如,用于防止用户以不安全的方式移动工具50)或者改变触觉设备30的模式(例如,从触觉模式到自由模式)。在此较佳实施例中,对由用户操纵且最接近于外科手术部位的接口37施加约束。对于遥控操作的触觉设备,即包括由外科医生操作并通常远离外科手术部位的“主”设备,以及在最接近外科手术部位处握住外科手术工具并由主设备控制的“从”设备,可以对主设备、从设备或两者施加约束。
在一个实施例中,故障信号在触觉描绘算法确定工具50对触觉边界的穿透深度超过预定阈值的情况下发出。预定阈值可以是例如范围在约1mm至约1.25mm之间的穿透深度。在一个实施例中,触觉描绘算法基于正由触觉设备30施加给用户的触觉旋量(即,力和/或扭矩)来确定是否超过预定阈值。例如,触觉描绘算法可以包括线性力与位置的关系曲线,其中触觉力被设置为约20,000N/m(或者20N/mm)。例如,如果用户移动工具50的尖端至1mm的穿透深度,触觉设备30就输出约20N的触觉力。类似的,如果用户移动工具50的尖端至1.25mm的穿透深度,触觉设备30就输出约25N的触觉力。在这一实施例中,故障信号在触觉力达到约22.5N,即对应于约1.125mm的穿透深度时被触发。另外,触觉力阈值可用于防止触觉设备30生成过高的力。例如,触觉对象可以被设计为独立基元(primitive)(例如,简单几何形状)并且在触觉描绘期间被组合。如果基元的累积效应是不期望的(例如,总触觉力过高),那么就可以发出故障信号。
在另一个实施例中,故障信号可以在检测到例如由人体跟踪器43a和43b的速度指示人体快速运动的情况下发出。快速运动可以在例如人体转移或者跟踪元件或者检测设备41被撞倒的情况下发生。在一个实施例中,在人体跟踪器43a的速度大于约40mm/s或者在人体跟踪器43b的速度大于约26mm/s的情况下发出故障信号。快速运动的指示还可以基于位置(与速度相对),诸如当人体跟踪器43a或43b的位置突然显著改变时。突然改变可以在例如从跟踪系统40报告的最后已知良好位置到跟踪系统40报告的当前位置的改变大于预定阈值的情况下指示。除了人体的快速运动之外,故障信号还可以在检测到触觉设备跟踪器45的快速运动的情况下发出,诸如在触觉设备跟踪器45具有较高速度或者其位置突然改变时,这可能指示了跟踪器45已经被撞倒或者没有被牢固固定至臂34。
外科手术系统10可以具有不同的故障水平或级别。例如,在一个实施例中,存在三个故障级别。第一故障级别在工具50的尖端穿透触觉边界过深或超出时施加。第二故障级别在检测到人体的快速运动时施加。第三故障级别在出现系统故障时施加。外科手术系统10通过对触觉设备30加以约束来响应各故障级别。例如,外科手术系统10可以通过禁用工具50来响应第一故障级别。外科手术系统10可以通过禁用工具50和触觉制导两者来响应第二故障级别。在检测到人体的快速运动时(例如,在患者的腿从手术台上滑落时)禁用触觉制导能够有利地防止定义触觉切割体积的虚拟触觉表面与落下的骨一起移动并沿着下落轨迹拉动工具50。与之相反,如果在骨快速移动时没有禁用触觉表面,那么触觉表面将跟随骨并且触觉设备30将对臂33施加一个较大的力来维持工具50处于下落的触觉体积内。结果是臂33将随着骨下落而向下拉动。禁用触觉制导可以避免这一危险情形。外科手术系统10可以通过禁用工具50、关断臂33的供电并锁定臂33的制动器来响应第三故障级别。在一个实施例中,外科手术系统10通过禁用工具50并将触觉设备30置于自由模式(而非应用制动器)以使得臂33不会拉动人体或对人体施加压力来响应故障信号。以此方式,外科手术系统10就通过防止用户在不安全条件存在时操作工具50和/或臂33来避免对人体的损害。
在一个实施例中,外科手术系统10的安全特征部件包括工具禁用特征部件。例如,如果工具50是电动工具,则外科手术系统10可以包括沿着工具50和控制工具50的用户输入设备之间的电连接放置的继电器。例如,继电器可以位于脚踏板和工具控制台(例如,结合工具50在上文描述的踏板和控制台)之间。可选地,继电器可以沿着手持仪器的控制线缆放置。在气压工具的情况下,气压关断阀可以放置在用户输入设备和工具电机之间的空气连接中。作为继电器的代替,外科手术系统10可以向工具控制台上的“禁用输入”端口提供数字或模拟信号。在一个实施例中,外科手术系统10包括在常规操作条件下闭合的继电器,使得工具50在用户压下脚踏板时被激活。如果检测到故障条件,外科手术系统10就发出故障信号并指令继电器断开,使得工具50即便在用户压下脚踏板时也无法被激活。在另一个实施例中,继电器是“通常断开”继电器,使得工具50将保持关闭或禁用状态直到工具50被外科手术系统10明确启用。“通常断开”继电器的一个好处在于如果触觉设备30完全关断,则工具50将被禁用。作为通过指令继电器或关断阀禁用工具50的可选或替换,故障条件可以通过指令关闭控制台电源或用于驱动工具50的电源或放大器来触发外科手术系统10禁用工具50。
在一个实施例中,一种基于工具禁用特征控制触觉设备30的方法,包括:(a)启用触觉设备30的操作;(b)操纵触觉设备30对患者执行一过程;(c)确定患者人体和触觉设备30的工具50的位置、方向、速度和/或加速度之间的关系是否对应于期望关系;以及(d)如果该关系没有对应于期望关系或者如果检测设备41无法检测到人体或工具50,则发出故障信号和/或对触觉设备30加以约束。该关系可以基于例如人体和工具50之间的期望交互。在一个实施例中,该关系由相对于人体确定位置并表示植入物的期望定位和/或用于安装该植入物的切割表面的虚拟对象来定义。本方法还包括基于上述关系来实现用于控制触觉设备30的控制参数以提供对用户的触觉制导和限制用户对外科手术设备的操纵中的至少一种。在一个实施例中,响应于故障信号,外科手术系统10禁用触觉设备30的操作,将触觉设备30的一部分锁定在位置上和/或将触觉设备30置于安全模式。在安全模式下,触觉设备30的操作和/或操纵可以被阻止或约束。为了确定该关系是否对应于期望关系,外科手术系统10可以例如确定工具50进入与人体相关联的虚拟边界的穿透深度是否超过期望的穿透深度,确定触觉设备30是否已经违反了操作约束(例如,由触觉描绘算法生成的参数),和/或确定检测设备41是否能够检测人体的位置和/或工具50的位置。
在另一个实施例中,外科手术系统10的安全特征包括遮断检测算法,后者适于在切割操作期间在关联于触觉设备30和/或人体的跟踪元件(例如,跟踪器43a、43b、45)变得遮断的情况下减轻危险。遮断状态会存在于例如下列状况:当检测设备41无法检测跟踪元件(例如,当在跟踪元件和检测设备41之间插入人或对象)时,当检测设备41的透镜(例如,被灰尘)遮断时,和/或当跟踪元件上的标记的反射性(例如,由于血、组织、灰尘、骨碎片等)下降时。如果检测到遮断状态,遮断检测算法就例如通过在显示设备23上显示警告消息、发出听觉警报和/或生成感触式反馈(例如,振动)来警告用户。遮断检测算法还可以发出控制信号,诸如让外科手术系统10关闭对工具50的电源或以其他方式禁用工具50或者对触觉设备30加以约束(例如,提供触觉制导、改变触觉设备30的模式等)的命令。以此方式,遮断检测算法就能在跟踪系统40无法精确确定工具50和人体的相对位置时防止工具50损伤人体。
在一个实施例中,遮断检测算法考虑工具50相对于触觉边界的位置。在这一实施例中,如果遮断检测算法检测到遮断状态,外科手术系统10就确定工具50是否正触及触觉对象的触觉边界。如果工具50在遮断事件发生之时没有接触触觉边界,遮断检测算法就禁用工具50并将触觉设备30置于自由模式,使得工具50将与患者一起移动并且在需要时离开患者。当遮断状态结束时(例如,当所有的遮断跟踪器变得可见),外科手术系统10就将触觉设备30置于接近模式使得用户能够恢复该过程。以此方式,遮断检测算法就能够在用户没有在遮断事件之时推触觉墙的情况下允许对触觉边界的去激活。与之相反,如果外科手术系统10确定工具50在遮断事件之时正触及触觉边界和/或超过触觉边界,那么遮断检测算法就等待预定时段(例如,1秒)以观察被遮断的一个或多个跟踪器是否变得可见。在此期间,禁用工具50并警告用户一个或多个跟踪器被遮断(例如,经由视觉、听觉或感触式信号)。如果触觉设备跟踪器45和人体跟踪器43a和43b在预定时段内全部变得可见,则恢复触觉(或钻动)模式。否则,就将触觉设备30置于自由模式使得工具50将与患者一起移动并且在需要时能够从患者身边移开。与前述类似,当遮断状态结束时(例如,当所有的遮断跟踪器再次变得可见),外科手术系统10就将触觉设备30置于接近模式使得用户能够恢复该过程。利用预定时段(或时间间隔)的一个好处在于遮断检测算法允许触觉墙在瞬间遮断事件期间保持活动。另外还避免了触觉墙的突然移除,后者可能会导致切割期间外科医生的突然运动。另外,如果遮断状态在预定时段内不复存在,就重置用于动态跟踪(运动补偿)的低通滤波器以防止跟踪系统40将较小运动察觉为不连续运动。
图14示出了遮断检测算法的一个实施例的框图。在步骤S3500,触觉设备30处于触觉(或钻动)模式下。在步骤S3502,该算法确定触觉设备跟踪器45及相关人体跟踪器对检测设备41都可见(即,未被遮断)。相关人体跟踪器是与关注的骨相关联的人体跟踪器。于是,对于膝关节置换过程,如果外科医生制备股骨F,则相关人体跟踪器是人体跟踪器43a。类似的,如果外科医生制备胫骨T,则相关人体跟踪器是人体跟踪器43b。虽然还可以监视额外的人体跟踪器,但是遮断检测算法优选地仅监视相关人体跟踪器以避免不必要的假触发(例如,基于与关注骨以外的人体部分相关联的跟踪器遮断的触发)。如果触觉设备跟踪器45和相关人体跟踪器都是可见的,那么该算法就行进至步骤S3504并启用外科手术工具50。外科手术工具50可以例如通过为工具50提供电源来启动,使得工具50可以被用户通过诸如压下脚踏板来激活。如图14的循环(步骤S3500、S3502和S3504)所示,只要这两个跟踪器可见,触觉设备30就继续处于触觉模式且外科手术工具50处于启用状态。
与之相反,如果检测设备41在步骤S3502中无法检测触觉设备跟踪器45和/或相关人体跟踪器,该算法就断定至少一个跟踪器被遮断并且行进至步骤S3506。外科手术工具50可以例如通过关闭工具50的电源来禁用,使得工具50即便在用户尝试提供诸如压下脚踏板来激活工具50的情况下也无法被用户激活。在禁用工具50之后,该算法就行进至步骤S3508并且向用户提供存在遮断状态的指示。该指示可以是任何合适的信号,诸如显示设备23上的视觉信号、听觉信号(例如,哔哔声、警报或其他警告声)、感触式信号(例如,振动)和/或控制信号(例如,指令触觉设备30将臂33原地锁定的控制信号)。在步骤S3500,该算法确定是否检测到触觉力。触觉力在例如触觉设备30向用户提供力反馈(例如,触觉制导和/或对用户操纵臂33的限制)之时被检测。如果在步骤S3510中没有检测到触觉力,该算法就行进至步骤S3518,去激活该触觉模式并启用自由模式。当触觉设备30处于自由模式时,工具50将与患者一起移动并且在需要时能够从患者身边移开。当遮断状态结束时,外科手术系统10将触觉设备30置于接近模式,使得外科医生可以继续该过程。
与之相反,如果检测到触觉力,该算法就行进至步骤S3512并且将触觉设备30维持在触觉模式下。在步骤S3514,该算法确定触觉设备跟踪器45和/或相关人体跟踪器是否仍然被遮断。如果跟踪器未被遮断,该算法就返回步骤S3500,该步骤中触觉设备30维持在触觉模式30下使得外科医生可以继续该过程。与之相反,如果至少一个跟踪器仍然被遮断,该算法就行进至步骤S3516并且确定自从检测到遮断状态开始是否已经经过了时间t。时间t可以基于应用来选择。在一个实施例中,时间t约为1秒。如果时间t尚未过去,则该算法返回步骤S3514。如果时间t已经经过,则该算法行进至步骤S3518,去激活触觉模式并启用自由模式。当触觉设备30处于自由模式时,工具50将与患者一起移动并且在需要时能够从患者身边移开。当遮断状态结束时,外科手术系统10将触觉设备30置于接近模式,使得外科医生可以继续该过程。以此方式,遮断检测算法就能够在外科手术系统10无法确定触觉设备30和人体的相对位置时有利地限制用户激活工具50的能力。结果就能够减小损害人体的危险性。
遮断检测算法的另一个实施例包括一种用于控制触觉设备30的方法,该方法包括如下步骤:(a)用检测设备41检测包括人体和与该人体相关联的跟踪元件的至少一个的第一对象;(b)用检测设备41检测包括触觉设备30和与该触觉设备30相关联的跟踪元件的至少一个的第二对象;以及(c)如果检测设备41无法检测第一对象和/或第二对象则向用户提供指示。该指示可以是诸如视觉、听觉、感触式和/或控制信号之类的信号,或者可以通过禁用触觉设备30的至少一部分,诸如工具50来提供。在一个实施例中,本方法包括对触觉设备30加以约束,诸如约束触觉设备30的至少一部分(例如,臂33、工具50)的移动或者限制触觉设备30的操作(例如,关闭对工具50的电源或者以其他方式禁用工具50,改变触觉设备的模式等)。优选地在一预定时间间隔(例如,如上结合图5的步骤S3516讨论的1秒)之后移除该约束。本方法还包括仅在检测设备41能够检测到第一对象和第二对象两者时才启用触觉设备30。
在一个实施例中,遮断检测算法确定触觉设备30是否正向用户提供触觉制导和/或限制用户对触觉设备30的操纵。触觉制导和/或对用户操纵的限制例如可以基于与人体相关联的虚拟边界。如果正提供触觉制导和/或对用户操纵的限制,则优选地维持该触觉制导和/或对用户操纵的限制以避免损害人体(例如,在用户正用工具50推压虚拟边界时由虚拟边界或触觉墙的突然移走而导致的损害)。因此,如果触觉设备30的一部分(例如,工具50的尖端)最接近于、接触或者超过该虚拟边界,则优选地维持该虚拟边界。本方法还包括如果触觉设备30的该部分没有与虚拟边界交互(例如,如果工具50没有接触虚拟边界或触觉墙),则去激活该虚拟边界。在此情形下,因为用户没有用工具50推压虚拟边界,所以工具50在虚拟边界被突然移走的情况下也不会损害人体。结果就能够降低损害人体的危险性。
这样,本发明的各实施例就提供了一种外科手术系统,该系统能够与外科医生协助交互,从而让外科医生能够以微创方式在骨上雕刻复杂形状,并且具有以一种保护患者并对外科医生基本透明的方式动态补偿内操作环境中各对象运动的能力。
一种用于验证外科手术设备的校准的系统和方法在于2007年5月18日由Louis Arata、Sherif Aly、Robert Van Vorhis、SandiGlauser、Timothy Blackwell、Rony Abovitz和Maurice R.Ferre提交的题为“System and Method for Verifying Calibration of a SurgicalDevice”的美国专利申请序列号____中公开,该申请全文通过引用结合在此。
Claims (33)
1.一种用于控制外科手术设备的方法,包括以下步骤:
操纵该外科手术设备对患者执行一过程;
确定在该患者的人体和该外科手术设备的外科手术工具的位置、方向、速度和加速度中的至少一项之间的关系是否对应于在该人体和该外科手术工具的位置、方向、速度和加速度中的该至少一项之间的期望关系;以及
如果存在该关系没有对应于期望关系的情况以及检测设备无法检测到人体位置和外科手术工具位置中的至少一项的情况中的至少一种情况,则对该外科手术设备加以约束。
2.如权利要求1所述的方法,其中该期望关系由触觉描绘算法生成的至少一个参数定义。
3.如权利要求1所述的方法,其中确定该关系是否对应于该期望关系的步骤包括确定该外科手术设备是否违背了由触觉描绘算法生成的至少一个参数。
4.如权利要求1所述的方法,其中确定该关系是否对应于该期望关系的步骤包括确定该外科手术工具对关联于该人体的虚拟边界的穿透深度是否超过预定阈值。
5.如权利要求1所述的方法,其中确定该关系是否对应于该期望关系的步骤包括确定人体、被跟踪对象、置于被跟踪对象上的跟踪元件中的至少一个的速度是否超过预定阈值。
6.如权利要求1所述的方法,其中确定该关系是否对应于该期望关系的步骤包括确定人体、被跟踪对象、置于被跟踪对象上的跟踪元件中的至少一个的位置是否处于预定边界之外。
7.如权利要求1所述的方法,其中确定该关系是否对应于该期望关系的步骤包括确定该外科手术设备的输出力是否超过预定阈值。
8.如权利要求1所述的方法,还包括以下步骤:
确定该外科手术工具是否正与关联于该人体的虚拟边界相交互。
9.如权利要求8所述的方法,其中如果该外科手术工具没有正与该虚拟边界相交互,则还包括去激活该虚拟边界的步骤。
10.如权利要求8所述的方法,其中如果该外科手术工具是正在接触该虚拟边界和超过该虚拟边界中至少之一,则还包括维持该虚拟边界的步骤。
11.如权利要求1所述的方法,还包括以下步骤:
基于在该人体和该外科手术工具的位置、方向、速度和加速度中至少一项之间的关系,实现用于控制该外科手术设备的控制参数,以向用户提供触觉制导以及用户对外科手术设备的操纵限制中的至少一种。
12.如权利要求1所述的方法,其中加以约束的步骤包括限制该外科手术设备的至少一部分的移动和限制该外科手术设备的操作中的至少一种。
13.如权利要求1所述的方法,其中该约束包括由触觉描绘算法生成的至少一个参数。
14.如权利要求1所述的方法,还包括以下步骤:
在预定时间间隔之后移去施加的约束。
15.如权利要求1所述的方法,还包括以下步骤:
用检测设备检测第一对象,该第一对象包括人体和关联于该人体的跟踪元件中的至少一个;
用检测设备检测第二对象,该第二对象包括外科手术设备和关联于该外科手术设备的跟踪元件中的至少一种;以及
如果检测设备无法检测到第一对象和第二对象中的至少一个则向用户提供指示。
16.如权利要求15所述的方法,还包括仅在检测设备检测到第一对象和第二对象时才启用该外科手术设备的步骤。
17.一种用于控制外科手术设备的方法,包括以下步骤:
操纵该外科手术设备对患者执行一过程;
基于在该患者的人体和该外科手术设备的外科手术工具的位置、方向、速度和加速度中的至少一项之间的期望关系约束对该外科手术设备的操纵;以及
如果存在期望关系没有被维持的情况以及检测设备无法检测到人体和外科手术工具中的至少一个的情况中的至少一种情况,则限制外科手术工具的移动和外科手术工具的操作中的至少一种。
18.一种用于控制外科手术设备的系统,包括:
外科手术设备,被配置为由用户操纵以对患者执行一过程;
耦合至该外科手术设备的外科手术工具;以及
计算系统,被编程为:
确定在该患者的人体和该外科手术工具的位置、方向、速度和加速度中的至少一项之间的关系是否对应于在该人体和该外科手术工具的位置、方向、速度和加速度中的该至少一项之间的期望关系;以及
如果存在该关系没有对应于期望关系的情况以及检测设备无法检测到人体位置和外科手术工具位置中的至少一项的情况中的至少一种情况,则对该外科手术设备加以约束。
19.如权利要求18所述的系统,其中该期望关系由触觉描绘算法生成的至少一个参数定义。
20.如权利要求18所述的系统,其中该计算系统被编程为:
确定该外科手术设备是否违背了由触觉描绘算法生成的至少一个参数。
21.如权利要求18所述的系统,其中该计算系统被编程为:
确定该外科手术工具对关联于该人体的虚拟边界的穿透深度是否超过预定阈值。
22.如权利要求18所述的系统,其中该计算系统被编程为:
确定人体、被跟踪对象、置于被跟踪对象上的跟踪元件中的至少一个的速度是否超过预定阈值。
23.如权利要求18所述的系统,其中该计算系统被编程为:
确定人体、被跟踪对象、置于被跟踪对象上的跟踪元件中的至少一个的位置是否处于预定边界之外。
24.如权利要求18所述的系统,其中该计算系统被编程为:
确定该外科手术设备的输出力是否超过预定阈值。
25.如权利要求18所述的系统,其中该计算系统被编程为:
确定该外科手术工具是否正与关联于该人体的虚拟边界相交互。
26.如权利要求25所述的系统,其中该计算系统被编程为:
如果该外科手术工具没有正与虚拟边界相交互,则去激活该虚拟边界。
27.如权利要求25所述的系统,其中该计算系统被编程为:
如果该外科手术工具是正在接触该虚拟边界和超过该虚拟边界中至少之一,则维持该虚拟边界。
28.如权利要求18所述的系统,其中该计算系统被编程为:
基于在人体和外科手术工具的位置、方向、速度和加速度中的至少一项之间的关系,实现用于控制该外科手术设备的控制参数,以向用户提供触觉制导以及用户对外科手术设备的操纵限制中的至少一种。
29.如权利要求18所述的系统,其中该计算系统被编程为:
通过限制该外科手术设备的操作和该外科手术设备的至少一部分的移动中的至少一种来加以约束。
30.如权利要求18所述的系统,其中该约束包括由触觉描绘算法生成的至少一个参数。
31.如权利要求18所述的系统,其中该计算系统被编程为:
在预定时间间隔之后移去施加的约束。
32.如权利要求18所述的系统,其中该计算系统被编程为:
用检测设备检测第一对象,该第一对象包括人体和关联于该人体的跟踪元件中的至少一个;
用检测设备检测第二对象,该第二对象包括外科手术设备和关联于该外科手术设备的跟踪元件中的至少一个;以及
如果检测设备无法检测到第一对象和第二对象中的至少一个则向用户提供指示。
33.如权利要求32所述的系统,其中该计算系统被编程为:
仅在检测设备检测到第一对象和第二对象时才启用该外科手术设备。
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