CN101444424A - 导管的导引控制及成像设备 - Google Patents

导管的导引控制及成像设备 Download PDF

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CN101444424A
CN101444424A CNA2008101748796A CN200810174879A CN101444424A CN 101444424 A CN101444424 A CN 101444424A CN A2008101748796 A CNA2008101748796 A CN A2008101748796A CN 200810174879 A CN200810174879 A CN 200810174879A CN 101444424 A CN101444424 A CN 101444424A
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耶霍舒亚·沙哈尔
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Abstract

一种系统,用于探测、显示和导引带磁性顶端之外科工具的位置,以快速、准确、简单而直观地实施诊断及治疗程序。所述外科工具包括导管、导向线,以及诸如激光器、气囊等二次工具及活组织检查针、内窥镜等类似器件。磁性顶端令使用者无需借助X射线只需分析磁场便可确定该顶端的位置及取向。磁性顶端还令使用者可通过在患者体外加给适宜磁场的方式推、拉、旋转该工具顶端,并将其可靠地固定在所需位置。一个“虚拟顶端”用为操作者控制手段。患者体内的磁性顶端运动情况与虚拟顶端的运动相应。若磁性顶端遇到阻碍,该控制手段向操作者的手发出适宜方向的触觉反馈。侍服系统根据该控制手段的输出连同感受到的磁性顶端位置及取向数据,以调制定位电磁体脉冲宽度的方式控制外磁场。根据如搏动之心脏等体内运动器官的动态位置数据等,以适宜的方式修正侍服系统,使磁性顶端,因而使二次工具与该体内运动器官一致地运动。根据顶端的位置、取向信息及体内运动器官的动态位置信息显示反映磁性顶端相对体内运动器官的相对位置、方向的三维视像。

Description

导管的导引控制及成像设备
本申请系申请号为CN 03821597.7,其国际申请日为2003.7.16,申请人为麦格耐泰克斯公司,并且题为《导管的导引控制及成像设备》的分案申请。上述在先申请系国际申请号为PCT/US03/22122的PCT申请,该申请要求优先权,所述优先权的—
在先申请国    在先申请日    在先申请号
美国           2002.7.16     60/396,302
技术领域
本发明涉及一种引导、操纵和送进诸如导管及导管类器件等侵害性医疗器件所用的系统和技术。
背景技术
一般地说,导管插入术乃是通过切口或身体上的孔口将侵害性器件插入体内。诸如导向线、气囊等二次工具通常沿着主导管送进到待实施医疗程序的区域里。导管插入术依靠手工推、拉、旋转或操纵留在体外的近端部分,以送进这种侵害性器件。插入过程中,通用的方法是采用实时X射线成像来确定所述侵害性器件的远端的位置。在该器件的远端到达待进行诊断或治疗的目标区域之前,操作者要不断的进行上述操作。这项技术要求操作者具有很高的技艺,操作者只有在经过较长时期的训练及广泛的实践后才能够达到这样的水平。这项技术还要求操作者具有灵巧的手工操作能力。
例如,血管成形术包括将一气囊导管顺着一条预先放置的导向线送进到动脉狭窄段中。一旦该导管到达狭窄动脉段内的合适位置上,便可使气囊膨胀,从而使该段血管扩张。血管成形术遇到了和血管造影术相似的技术困难。如果待处理的动脉带有剧烈的扭曲,就可能难以将导向线送进到狭窄部位上。如果动脉严重狭窄或是完全堵塞,这就更难或是根本不可能将导向线定位到合适的位置上。另一方面,不管导向线是否成功地定位到抱紧的硬斑位置上,直径必须大于导向线的气囊导管可能会遇到足够大的阻力而使得被导引的导管和孔口分离,使其得不到使气囊顺利送进所需要的支承。这样的技术困难可能会使医疗程序进行不下去。
由于难以将导管插入到体内的要求位置上,许多诊断、治疗程序使用一种导向线。首先,将导向线送进到心脏或动脉内作为一条轨道来导引特定的导管。这种技术通常用来将一条导管送进到左心室内,这对主动脉狭窄的研究是特别重要的。对于操作者来说,如何通过狭窄的瓣膜口是一个挑战。同样,经常要操纵一个导向线进入阻塞的冠状动脉以及穿过有阻碍的斑块。一种比如带有气囊、激光器、支架等治疗手段的治疗导管要在该导向线上推进并布置到斑块位点上。然后通过气囊的膨胀、激光束的作用,或者支架的支承来打开狭窄位点。有时,动脉是弯曲的并严重狭窄的,并且斑块是不规则的,而且已经钙化,或者甚至使动脉完全闭塞。这种情况下,如何将导向线穿过狭窄位点便是非常困难而会经常失败的事情。
在有些医疗程序中,会用一条导管来割穿房中隔,以制作一条旁路(大血管错位)来处理左房室瓣(左房室瓣膜形成术),或是用来直接监护左心房的压强。
为了使心脏节律或传导紊乱的患者得以存活,经常必须植入心脏起搏器。这个医疗程序是将一个小型电极植入患者的心腔(心室或心房)壁内。电极的另一端与一个被植入在胸部皮肤下的电子器件相连,该电子器件发出刺激脉冲刺激心脏的节律。同样,当电极(例如可植入的自动心脏去纤颤器(AICD))检测到患者发生威胁生命的电紊乱时,可以以相似的电器件对患者施加电冲击。这些电极都可通过静脉在X射线照射下手工操作推入。许多情况下,由于解剖学上的差异,手工操作难以将电极安放到合适位置上,结果达不到最佳效果。
电生理学研究中,要测量并记录心肌(心脏肌肉)内发生的电信号,测量时,要将一个带有电极的导管送进到心脏中,在电极触及感兴趣的心内膜区域之前一直要手工操纵着该导管。这是一件繁重而费时的工作,因为,为了完成一项全面的研究常常需要进行许多这样的测量。另外,用手工操纵的方法使电极准确定位也是一个困难的过程。
在先前的电生理学研究中,曾经在心肌内发现过一些错误的电路径,这种错误路径会导致可能威胁生命的异常心律。为了消除心律困扰,为了消除这种可能威胁生命的异常心律,就要使这种错误的电路径消融。为了消融这种电路径,主要的方法是采用一种携带能量的导管向预定的特定区域输送热能或微波能量。这样的导管要和选定的心内膜区域良好接触,否则将不会发生消融作用。另外,为了不破坏正常的电路径,该导管必须准确定位。面临这样精确的要求,手工操纵的不准确性使得这种操作程序变得特别困难而费时。
左房室瓣膜形成术可以用来治疗左房室瓣狭窄,这种技术采用一个气囊来使狭窄的瓣膜扩大。现有的方法包括:通过静脉腔道将一导管送进到右心房中,并在房中隔上制作一个切口,并使导管强制穿过该切口进入左心房中。然后将一个气囊通过导管送入左房室瓣中,并使气囊膨胀以撑破狭窄组织。这种医疗程序的成功率不高,但瓣膜重新狭窄的可能性却不低,已知的难点是房中隔刺穿会导致中隔缺陷。尽管这种程序的侵害性大大小于外科手术,但与一般的导管插入术相比,这种程序的困难更大,时间更长,并要求操作者有特别熟练的技艺。
有些人考虑过用从主动脉直接进入左心房的左房室瓣膜形成术来替代从静脉腔道进入心脏的左房室瓣膜形成术,因为这种方法可以避免刺破房中隔,从而免除了可能存在的中隔缺陷。与现有的左房室瓣膜形成术不同的是,这种方法的导管是从主动脉送进到左心房及主动脉瓣而被定位在左心室中的。气囊通过导管送进到左房室瓣中,并膨胀而撑破狭窄组织。由于需要用相对较为刚硬的气囊来撑破导致左房室瓣狭窄的组织,因此,几乎不可能使气囊合适地对准主动脉和左心室,这是因为主动脉通道和要求的进入左房室瓣的路径之间呈一个尖锐的夹角。
心肌血管再建术是一种治疗程序,该程序通过在心肌中诱发形成新的小血管的途径来增加通向心肌的血液供应。该外科手术包括打开胸腔壁,并用激光器在心脏外表(心外膜)上“钻”上许多小通道。
经皮的心肌血管再建术是一种利用导管实施的治疗程序,用来促进血管新生。这种血管再建术包括将一个激光器导管送进到心脏内,并从心脏内表面(心脏内膜)一侧形成通道。这种治疗程序特别适合于那些构成高度外科手术危险因素的患者,以及不能经受常规的导管治疗的患者。由于这种程序在进行激光器导管的定位及固定时所要求的准确度,因此难以利用现有的导管技术予以实现。
上述各项医疗程序存在不少缺点和局限性。为了操纵导管使其合适地进入要求位置,通常要求操作者具有非常高的技艺水平。为了达到这种技艺水平,就要求对操作者进行广泛的培训。许多医疗程序是冗长而费时的,这使得患者和工作人员反复且长期地暴露在不利的X射线作用下。冗长的程序还使得患者需要蒙受由于接受更多的影像对比度增强剂(contrastmaterial)所带来的危险。通常,要求导管远端(亦称导管顶端)高精度定位的医疗程序都是难以实现,而且是不现实的。在二次工具的插入、取出以及其它操作过程中,导引导管的顶端经常会被迫偏离要求位置,从而需要费不少时间来重新进行操作,以对顶端进行重新定位。冠状动脉有时扭曲而带有剧烈的弯曲或阻塞,这使得导向线或气囊前进困难或甚至不可能前进。导管顶端的位置信息主要依靠X射线成像系统,这将带来不利的副作用。
针对上述缺点和局限性,本发明提供一种引导、操纵及送进侵害性的医疗器件并准确地控制其位置所用的设备及方法;该设备及方法可以提供三维图像;该设备及方法可以使X射线或其它电离型的辐射使用降至最少。
发明内容
本发明通过提供一种磁性导管的导引及控制设备,以解决上述问题和其它问题。与先前的技术系统相比,本发明提供的设备需要更少的人员培训及更低的人员技艺水平要求。所述磁性导管导引系统可以使导管快速地被送进并定位,因此,可以将X射线及影像对比度增强剂的使用剂量降至最低。另外,所述磁性导管导引系统中所用的磁性系统也可以探测出导管顶端的位置,并将该位置信息提供给操作者,并控制系统。
本发明的一种实施例包括:一个导管和一个导引及控制设备,所述导引及控制设备使外科医生/操作者能够准确并且较容易地将导管顶端布置在患者体内的适当位置处。所述导引及控制设备还能够将导管顶端保持在正确位置上。本发明的一种实施例包括:一个导管及导引控制设备,所述导管及导引控制设备能够操纵一个导向线或气囊穿过动脉,并有力地将其推进穿过斑块或其它阻碍物。本发明的一种实施例包括:一个导管导引控制设备,所述设备可以显示导管顶端的现有位置,同时又使患者和工作人员的X射线的辐照量降至最小。本发明的一种实施例包括一个导管导引控制设备,所述设备的使用更加直观而简单,该设备以三维的方式显示导管顶端的位置,该设备对导管顶端施加力,以按照要求拉、推、旋转或固定该导管顶端,该设备还能够使导管顶端产生频率及振幅都可调的振动及脉动,以帮助将导管顶端送过斑块或其它阻碍物。本发明的一种实施例包括一个操作者控制机构,该控制机构还向操作者提供反映导管顶端所遇到的阻碍的触觉反馈。
按照一种实施例,一个导管导引控制及成像(GCI)装置使外科医生能够对一个导管进行送进、定位及固定,并能够通过显示器上叠加的X射线图像观察该导管的三维位置。按照一种实施例,所述装置包括一个被称为“虚拟顶端”的操作者控制机构,该控制机构除了存在一个代表实际导管顶端在患者体内位置的模型以外,还具有一个相对于导管顶端的位置关系。
所述虚拟顶端包括一个有些象电脑游戏杆那样的可供外科医生操纵的实体组件。把这种组件设计成当实际的导管顶端遇到阻碍就会向操作者发出合适方向的触觉反馈。换句话说,该虚拟顶端包括一个游戏杆形式的器件,该器件使外科医生得以导引实际导管顶端穿入患者的身体。当实际导管顶端遇到阻碍物时,该虚拟顶端便向外科医生发出表明遇到阻碍的触觉力反馈。
按照一种实施例,所述实际导管顶端(亦即导管的远端)包括一个永久磁体,该永久磁体对外界作用在患者身上的磁场作出响应。外磁场将该顶端推、拉旋转并固定到要求的位置上。本专业的技术人员都知道可以用一个电磁体来替代或增强这种永久磁铁。
操作者控制机构向侍服系统发出位置及取向指令,该侍服系统调节作用在患者身上的外界磁性力,以控制实际顶端的位置及取向。该实施例包括一个二次装置,所述二次装置包括磁场传感器及温度传感器,该二次装置测量实际顶端的位置及取向,并将测量结果反馈给侍服系统及操作者界面。按照一种实施例,所述侍服系统包括一个修正量输入,该修正量对于比如心脏等身体部分或者器官的动态位置作出补偿,从而对实际顶端的响应进行修正,使得实际顶端的运动和搏动中的心脏协调一致。
本发明导管导引系统的工作过程如下:1)操作者调整虚拟导管顶端的实体位置;2)所述虚拟顶端的位置变化经编码而成为输入数据,被输送给控制系统;3)所述控制系统生成指令,并发送给侍服系统控制装置;4)所述侍服系统控制装置操纵侍服机械,对外界磁体的电磁场进行调整;5)所述外界电磁场的改变使得实际导管的磁性顶端在患者体内的位置发生变化;6)实际导管顶端的新位置被磁场传感器及温度传感器阵列感知;7)该传感器阵列将感知的新位置信息反馈给侍服系统控制装置及操作者界面中的监视系统,从而对所显示的图像中实际导管顶端相对于所叠加的X射线图像中的患者的相对位置进行更新。
于是,操作者可以进一步调整所述虚拟导管顶端位置,并且可以平滑而连续地重复步骤2)至7)。此外,整个过程中,每当实际导管顶端在其路径中遇到阻碍或阻力时,来自侍服系统控制装置的反馈便会生成指令逻辑,这种指令逻辑被用于控制一个步进电机,该步进电机和所述虚拟导管顶端实体相连。所述步进电机使得虚拟导管顶端产生一个适宜方向的阻力,这种阻力能被操作者所感知,从而成为发送给操作者的触觉反馈。
附图说明
以下将参照进一步的描述、权利要求和附图详细描述本发明的各种特点及实现所述特点的方法。各附图中以相同的标号表示相应参照项目。
图1A是一个外科程序系统的高级系统方块程序图,其中包括操作者界面、导管导引系统、外科设备(如待导引之导管)及患者;
图1B是图1所示导管导引系统一种实施例的方块程序图;
图1C是图1B所示导管导引系统的方块图,示出图1B未予表示的一些附加细节;
图2是图1B所示装置中使用的接地故障断路器、不间断电源、直流电源及监管单元的示意图;
图3是图1B所示装置中使用的系统控制器示意图;
图4是图1B所示装置中使用的虚拟顶端及校准附件控制器的示意图;
图5是图1B所示装置中使用的虚拟顶端的电路方框图;
图6是与图5所示电路方块图相连的虚拟顶端的透视图;
图7是图1B所示装置中使用的X轴控制器及放大器的示意图;
图8是图1B所示装置中使用的Y轴控制器及放大器的示意图;
图9是图1B所示装置中使用的Z轴控制器及放大器的示意图;
图10是图1B所示装置中使用的通信控制器的示意图;
图11是图1B所示装置中使用的校准附件示意图;
图12是图11校准附件(机械)的透视图。
图13是表示电磁体及相应磁场传感器极性配置的正视图;
图13A是表示作为由一C形臂形成磁路的一簇电磁体的可能极性配置;
图13B表示螺线管、臂和台面的几何布局;
图13C是表示电磁螺线管簇的电子学布置的方框图;
图13D是矢量的矩阵表示;
图13E表示特征矩阵;
图13F表示逆特征矩阵;
图13G表示特征矩阵和其逆矩阵的乘积;
图13H是图13G的逻辑流程图;
图14是表示图1B装置中使用的各种磁场传感器和温度传感器对;
图15和图15A是图1B装置中使用的导管组件和导向线组件的分解透视图;
图15B表示一个带有磁性顶端及两个压电环的导管;
图16表示图1B的装置与一个双平面X射线环的结合;
图16A表示图1B装置的俯视图;
图16B表示图1B装置的端部视图;
图16C表示图1B装置的侧视图;
图17表示图1B所示装置与电影血管造影设备一起使用的情况;
图17A表示与X射线荧光图像同步的基准点标记;
图17B表示在作起搏器电极植入(implementation)过程中使用基准点标记的情况;
图18是表示图13的电磁体加给的合力矢量的大小和方向的向量图;
图18A表示导管的磁性顶端相对于坐标系统虚拟原点的极性;
图18B表示由图20和图20A所示磁场传感器测得的合成矢量;
图18C表示图18B所示合成矢量的三维角度;
图19表示图1B装置中使用的两个对置电磁体之间的距离;
图19A表示图19中邻近的电磁场传感器之间的距离。
图20是表示由图19A的磁场传感器数据推演图18A所示顶端位置的过程;
图20A表示由图19A的磁场传感器信号进一步计算的结果;
图21是表示图18A所示磁性顶端在Z轴方向上的旋转(θ)。
图22是表示图18A所示磁性顶端在Z轴方向上的平移(ΔZ)。
图23是图1B装置的控制器形成部件的逻辑流程图,用以确定图18A的实际顶端响应新运动指令所处的位置。
具体实施例方式
图1A、1B及1C表示系统700,它包括一个导引、控制、成像(GCI)装置501。该系统700还包括一个操作者界面部分500和外科医疗设备502。图1A所示为GCI装置501的一个实施例,该实施例包括各种功能单元。图1A还表明这些功能单元以及操作者界面部分500、手术室中的辅助设备502以及患者390之间的总体关系。图1B所示为这些功能单元及它们中一些部件之间的内部关系。
图1C所示为GCI装置501、外科医疗设备502、操作者界面设备500以及患者390之间的关系。有关GCI装置501及诸如手术室中的外科医疗设备502等其它辅助设备的详细情况将在下面结合图16、16A、16B和16C予以描述。所述系统700被构造成用以将导管或类似器件的远端(本文亦称顶端)导引进入患者体内。
图2所示为GCI装置501的第一功能单元,即电源及控制器单元的方块图。该功能单元包括接地故障断路器1、不间断电源300、直流电源16、17、18和19,以及图1B所示系统700用的监管单元301。
GCI装置501的另一功能单元是如图3所示的系统控制器(SC)302。GCI装置501还包括一个功能单元,即图4所示的虚拟顶端及校准附件控制器(VT/CFC)303。GCI装置501还包括一个功能单元,即图5和图6所示的虚拟顶端组件304。GCI装置501的其它功能单元包括:X轴控制器及放大器(XCA)305、Y轴控制器及放大器(YCA)310,以及Z轴控制器及放大器(ZCA)315。这些功能单元将通过图7、8和9所示的功能方块图逐项予以详细描述。GCI装置501的其它功能单元还包括通信控制器(CC)320(详见图10)、校准附件(CF)321(详见图11、12)、磁场传感器(MFS)和温度传感器(TS)对374(见图14)。图1B所示的系统700中采用不同种类的磁场传感器和温度传感器对374。一个或多个磁场传感器可以是霍尔效应传感器、超导传感器或其它传感器,只要该传感器能够感受,比如由导管顶端的磁体(或电磁体)引起的磁场。在一个实施例中,这种磁场传感器是霍尔效应传感器。温度传感器可以是热敏电阻或其它能够对温度敏感的传感器。本文之所以描述温度传感器是由于比如霍尔效应传感器等许多磁场传感器都是温度依赖型的传感器。然而,温度传感器是备选的器件。当温度传感器对精度的贡献并非必要时,或者无需考虑磁场传感器的温度依赖性时,可以省略所述温度传感器。
参照图1B,电源及控制系统392包括:接地故障断路器(GFI)1;不间断电源(UPS)300;监管单元(SU)301;分别向X轴控制器和放大器(XCA)、Y轴控制器和放大器(YCA)、Z轴控制器和放大器(ZCA)单独供电的直流电源(XPS)16、(YPS)17及(ZPS)18;以及向GCI装置501的数字电路及模拟电路供给直流电的直流系统电源(SPS)19。图2对这些部件及它们之间的功能关系作了详细表述。
参照图2,接地故障断路器(GFI)1的作用是作为安全器件,用以监控相线和中性线内的交流输入电流。如果测得二者电流不平衡,便可以设想为对地之间存在一个杂散导电路径(操作者或患者具有触电危险),这个检测器便会使载荷从馈线上脱开。
不间断电源(UPS)300包括电池9、充电系统5、变流器13和电源开关回路。在电源发生故障期间,UP S300自动地向系统700提供全部所需电能,直至电池耗尽。如果电源故障的持续时间超出电池容量以外,则监管单元(SU)301及系统控制器(SC)302便会将整个系统700适时地关掉。
再参照图2,放大器3及其变流器的作用是监测交流线路的电流。隔离放大器4的用途为监测接地故障断路器(GFI)1的交流电压输出。充电器5的用途是产生所需直流电能,给不间断电源300中的电池9充电。放大器8的用途是检测分流线路两端的电压降,以测定电池9的充电电流。放大器10的用途为监测电池9的输出电压。放大器12的用途是监测分流线路11两端的电压降,以测定电池9的负载电流。换流器13的用途为向GCI装置501的各个部件供给交流电能。隔离放大器14的用途为检测换流器13的交流输出电压。放大器15及其变流器的用途为监测换流器13的输出电流。
监管单元(SU)301监测来自下列部件的信号:交流馈线、接地故障断路器(GFI)1的输出端、不间断电源(UPS)300,以及直流电源16、17、18、19。监管单元(SU)301向系统控制器(SC)302报告下列情况:交流供电故障、接地故障断路器(GFI)脱落、不间断电源(UPS)故障或是直流电源16、17、18、19故障。
如图2所示,监管单元(SU)301包括模拟多路转换器20,该转换器20将待监测的给定信号连接到可编程增益放大器21上。解码逻辑单元26和地址锁存器24相连,从而使微控制器30能够设置所述模拟多路转换器20的输入通道。微控制器30执行存在于只读存储器28中的编码。解码逻辑单元26和地址锁存器25相连,这又使得微控制器30能够设定可编程增益放大器21的增益。于是,微控制器30通过解码逻辑单元26选通采样/保持电路22。因而,采样/保持电路22的输出便是待测量信号的一个“瞬象”。
模数变换器23接受微控制器30经解码逻辑单元26发来的变换指令。完成变换时,模数变换器23通过解码逻辑单元26遮断微控制器30,而通过微控制器30输出代表待测量信号的数字数据。随机存取存储器29的用途为在SU301工作过程中储存采样数据。非易失性存储器27的用途为在供电终止时储存数据。监管单元301通过这样的方式监测各种电压及电流。微控制器30通过缓冲器31与系统控制器302沟通。控制逻辑单元32使得系统控制器302能够根据系统的状态来配位“供电-掉电”数列。
参照图1C和3可见,系统控制器(SC)302以排序的方式控制供电-掉电次序,并通过通信控制器(CC)320、计算机324及监视器325提醒操作者注意系统状态,并采取任何所需的纠正措施。此外,系统控制器(SC)302还对X轴控制器和放大器(XCA)305、Y轴控制器和放大器(YCA)310及Z轴控制器和放大器(ZCA)315的工作进行配位,还经系统总线328与虚拟顶端/校准附件控制器(VT/CFC)321及通信控制器(CC)320沟通。
如图1C所示,侍服电源(XPS)16向X轴控制器和放大器(XCA)305供给直流电。X轴控制器和放大器(XCA)305向位于患者体外的电磁体132X及138X供电。X轴控制器和放大器(XCA)305还对温度传感器(TS)阵列306、309和磁场传感器阵列307、308以及电磁体(EM)132X、138X进行监测。磁场传感器阵列307、308测量X轴方向的磁通量。温度传感器(TS)306、309测量磁场传感器阵列307、308的温度,因此,X轴控制器和放大器(XCA)305能够通过温度补偿系数对磁场传感器的输出进行修正。
这些传感器阵列306、307、308、309测得的实际导管顶端377在X轴方向上的位置作为反馈被输出给X轴控制器放大器(XCA)305。通过下面的叙述可以看到两个电磁体132X及138X对实际导管顶端377在患者身体390内的X方向位置的影响。
侍服电源(YPS)17向Y轴控制器和放大器(YCA)310供给直流功率。Y轴控制器和放大器(YCA)310向位于患者体外的电磁体(EM)132Y及138Y供电。Y轴控制器和放大器(YCA)310还对温度传感器(TS)阵列311、314和磁场传感器阵列312、313进行监测。磁场传感器阵列312、313测量Y轴方向的磁通量。温度传感器(TS)311、314测量磁场传感器阵列312、313的温度,因此,所述Y轴控制器和放大器(YCA)310能够通过温度补偿系数对磁场传感器的输出进行修正。这些传感器阵列311、312、313、314测得的实际导管顶端377在Y轴方向上的位置作为反馈,输出给所述Y轴控制器和放大器(YCA)310。通过下面的叙述,将可看到这两个电磁体132Y及138Y对实际导管顶端377在患者身体390内的Y方向上位置的影响。
Z轴电源(ZPS)18向Z轴控制器和放大器(ZCA)315供给直流功率。Z轴控制器和放大器(ZCA)315向位于患者体外的电磁体(EM)132Z及138Z供电。Z轴控制器和放大器(ZCA)315还对温度传感器(TS)阵列316、318和磁场传感器阵列317、319进行监测。磁场传感器阵列317、319测量Z轴方向的磁通量。温度传感器(TS)316、318测量磁场传感器阵列317、319的温度,因此,所述Z轴控制器和放大器(ZCA)315能够通过温度补偿系数对磁场传感器的输出进行修正。这些传感器阵列316、317、318、319所测量到的实际导管顶端377在Z轴方向上的位置作为反馈,输出给Z轴控制器和放大器(ZCA)315。通过下面的叙述,将可看到这两个电磁体132Z及138Z对实际导管顶端377在患者身体390内的Z方向上的位置的影响。
通信控制器(CC)320将主机系统323、辅助设备322及计算机324连接到系统总线328上。外科及医疗设备502可以包括比如主机系统323及辅助设备322。所述主机系统323中含有关于患者和现行医疗程序的资料,还包含GCI装置501产生的档案资料。所述辅助设备322可以包括X射线成像系统及其它患者检测设备。
操作者界面500包括,如计算机324、监视器325、键盘326及鼠标327。计算机324使操作者能够调整系统参数,并执行校准及诊断等例行程序。监视器325显示实际导管顶端377的位置资料和重叠显示X射线图像,以及对操作者的提示。键盘326和鼠标327用于操作者录入数据。
虚拟顶端/校准附件控制器(VT/CFC)303接受来自虚拟顶端组件304的编码器位置、限止开关以及操作者开关等输入数据,这些数据是XCA395、YCA 310及ZCA315在对电磁体132X、138X、132Y、138Y、132Z、138Z进行控制时需要使用的。所述虚拟顶端/校准附件控制器(VT/CFC)303还将触觉反馈(TF)响应及发光二极管(LED)数据输出给虚拟顶端(VT)304,这两项输出将由操作者作为实际导管顶端377遇到的阻碍或阻力被感知的。
图3所示为系统控制器(SC)302的一个实施例的多个部件。后面将结合附图详细描述这些部件的功能。SC 302的特征在于它有不同的工作模式:1)供电/掉电模式、2)侍服系统控制器模式、3)触觉反馈响应模式,以及4)校准模式。
在供电/掉电模式时,所述SC 302对GCI装置501的各个部件的供电/掉电次序进行配位,实施内置的系统诊断功能,还将诊断过程中测得的任何差错资料发送到通信控制器(CC)320,并储存在存储器41中。通过微控制器33完成这些任务。当系统正在工作时,这些差错数据储存在随机存取存储器(RAM)41中,当系统掉电时,这些数据则储存在非易失性存储器(NVM)39中。微控制器33通过系统总线328和其它系统部件进行通信。通信时可以向解码逻辑单元38设置适宜的地址及控制码位,以启动地址缓冲器34及数据缓冲器35。类似地,经控制逻辑单元32,所述数据锁存器36及数据缓冲器37使微控制器33与不间断电源(UPS)300及监管单元(SU)301相连接。
在侍服系统控制器模式下,有如下面还要结合图23详细描述的那样,系统控制器(SC)302计算实际顶端(AT)的位置。然后,根据来自虚拟顶端(VT)405的数据确定现存的位置误差,也就是实际顶端的位置和虚拟顶端指示位置,即操作者要求的顶端位置之间的差异。该位置误差值将会通过系统总线328被发送给X轴控制器和放大器(XCA)305、Y轴控制器和放大器(YCA)310,以及Z轴控制器和放大器(ZCA)315。
在触觉反馈响应模式下,所述系统控制器(SC)302经系统总线328向虚拟顶端(VT)304提供反馈数据,以引发触觉反馈响应。下面还将结合图23进行详细描述。
在校准模式下,所述系统控制器(SC)302经虚拟顶端/校准附件控制器(VT/CFC)303对校准附件(CF)312产生影响,并将来自X轴控制器和放大器(XCA)305、Y轴控制器和放大器(YCA)310及Z轴控制器和放大器(ZCA)315的位置数据与校准附件(CF)321、编码器64C、66C、68C、70C及72C相关。
图4表示虚拟顶端/校准附件控制器(VT/CFC)303。当系统正在工作时,数据被储存在随机存取存储器(RAM)50中;当系统掉电时,这些数据被储存在非易失性存储器(NVM)48中。微控制器42经系统总线328与系统控制器(SC)302(见图3)进行通信联系。通信联系时,可以向解码逻辑单元47设置适宜的地址及控制码位,以启动地址缓冲器43及数据缓冲器44。如下所述,类似地,数据锁存器45及数据缓冲器46使微控制器42与虚拟顶端(VT)405或校准附件(CF)321相连。
虚拟顶端/校准附件控制器(VT/CFC)303接受来自VT304或CF 321的有关编码器位置,限止“开关”关闭,并且操作者输入开关位置等数据输入。虚拟顶端/校准附件控制器(VT/CFC)303还向虚拟顶端(VT)304输出数据,使其产生触觉反馈并亮起发光二极管指示器,以向操作者提示各种系统状况。
参照图5,VT组件304的电子电路功能如下。解码逻辑单元101响应来自虚拟顶端/校准附件控制器(VT/CFC)303(图3)的地址及控制码位启动数据缓冲器51,并设定它对于数据传输的方向。当解码逻辑单元101选通步进锁存器52、53时,所述锁存器52、53储存来自VT/CFC 303并且是待提供给步进驱动器54、56、58、60和62的数据。所述步进电机55、57、59、61和63响应步进驱动器的输出,向操作者发出触觉反馈。所述步进电机55、57、59、61和63按如下配位产生适宜方向或角度的阻力:步进电机55沿着X轴方向;步进电机57沿着Y轴方向;步进电机59沿着Z轴方向;步进电机61沿着角度θ方向;步进电机63沿着角度EL方向。
再参照图5,绝对编码器64、66、68、70和72与相应的步进电机55、57、59、61和63机械地耦接,并当存在触觉反馈(TF)时向VT/CFC 303提供位置反馈信息,而当操作者对VT 405进行手工调整时向VT/CFC 303提供虚拟顶端(VT)的位置信息。编码器的输出受到缓冲器65、67、69、71和73缓冲,以暂时储存并将轴向及角向位置信息传输给VC/CFC 303。限止“开关”74、75、76、77、78和79给三个轴线作上终端标记,以限止虚拟顶端405的机械运动,并可使虚拟顶端组件304的机械部分与图5的电子仪器同步工作。当角度θ及EL为0时,“开关”80及81发出指示,使虚拟顶端组件304的机械部分与图5的电子仪器同步工作。当被解码逻辑101选通时,锁存器82便储存这些给位置边界下定义的数据。由于操作者开关83、84、85、86、87、88、89和90都是瞬时性的开关(亦即瞬时接触而非稳定接触的开关),锁存器91读取并锁存这些开关,以储存它们的指令。由LED锁存器100驱动发光二极管92、93、94、95、96、97、98和99。
图7表示X轴控制器和放大器(XCA)305。XCA 305接受来自X轴磁场传感器阵列307、308及温度传感器阵列306、309测得的数据信号,并对其进行放大。微控制器102X根据这些测得的数据执行一个程序,以产生位置反馈信号,该位置反馈信号经系统总线328被输送给VT/CFC 303及其它系统部件。微控制器102X还通过系统总线328接受来自VT/CFC 303及其它系统部件的数据,并根据这些数据生成指令,该指令控制外电磁体132X、138X的励磁,对实际导管顶端在X轴方向上的位置产生影响。XCA 305还生成误差信号及修正信号,这些信号将用在校准过程和系统正常工作过程中。下面对这些功能进行描述。
首先说明XCA 305对来自MFS阵列307、308及温度传感器阵列306、309测得的数据的监测方法。磁场传感器阵列307包括传感器113X、114X、115X、116X。磁场传感器阵列308包括传感器117X、118X、119X、120X。温度传感器阵列306包括传感器122X、123X、124X、125X。温度传感器阵列309包括传感器126X、127X、128X、129X。图13示出这些传感器的实体位置以及相互的位置关系。可以结合图18、18A、18B和18C描述微控制器102X执行的数学程序,该数学程序根据来自传感器阵列307及308的输入数据计算输出的位置数据。在系统运行过程中,这种输入及输出数据都储存在随机存取存储器(RAM)103X中。诸如温度补偿系数等数据则储存在非易失性存储器(NVM)105X,该补偿系数和温度传感器阵列306、309测得的温度数据一起用于对来自磁场传感器113X、114X、115X、116X、117X、118X、119X、120X的数据进行必要的修正。
由解码逻辑单元106X连同地址锁存器111X触发检测数据的收集,该锁存器111X使微控制器102X能够设置模拟多路转换器112X的输入通道。同样,解码逻辑单元106X连同地址锁存器109X使微控制器102X能够设置可编程放大器110X的增益,以补偿来自传感器阵列307、308、306和309信号的强度变化。微控制器102X通过解码逻辑单元106X选通采样/保持电路108X,因此,所述微控制器能够在执行其它功能的同时,周期性地采集暂存在采样/保持电路108X中的数据。因此,采样/保持电路108X的输出便是待测量信号的一个“瞬象”。
微控制器102X通过解码逻辑单元106X向模数变换器(ADC)107X发出“变换”指令,将来自位置传感器307、308的模拟信号变换成数字数据,使数码系统能够判读该信号。完成变换时,模数变换器107X通过解码逻辑单元106X阻断微控制器102X,而由微控制器102X输入测量信号的数码表示。本发明就是用这样的方法对磁场传感器113X、114X、115X、116X、117X、118X、119X和120X以及温度传感器122X、123X、124X、125X、126X、127X、128X和129X进行监测的。与此相似,还对分流线路131X、137X两端的电压降进行测量,以确定通过电磁体132X、138X的电流。
再参照图7,电流源121X的用途是提供控制电流,以偏置磁场传感器113X、114X、115X、116X、117X、118X、119X和120X。这是因为这些传感器最好在恒定电流模式下工作,因此,要求电流稳定,以可靠地工作。温度传感器的偏置电源130X的用途是向温度传感器122X、123X、124X、125X、126X、127X、128X和129X提供偏置电压。
以下说明XCA 305生成指令以控制实际导管顶端277在X轴方向上运动的方法。微控制器102X经系统总线328接受来自VT/CFC 303及其它系统部件的数据,并根据这些数据生成控制实际导管顶端277在X轴方向上运动的指令。微控制器102X连同解码逻辑单元106X控制调制器144X及146X产生适宜的运动信号及指令。前置放大器143X及145X将调制器的输出放大,并驱动末级放大器135X、136X、141X和142X。二极管133X、134X、139X和140X的用途为保护末级放大器免受反电动势浪涌的冲击,该反电动势浪涌是由电磁体线圈132X、138X的电感特性所引起的。
电磁线圈132X、138X产生磁场,对实际导管顶端在X轴方向上的位置产生影响。
微控制器102X经系统总线328与VT/CFC 303及其它系统部件进行通信联系的方式是:微控制器102X对解码逻辑单元106X设置适宜的地址及控制码位,所述解码逻辑单元106X启动地址缓冲器148X及数据缓冲器147X。
非易失性存储器(NVM)105X也储存校准数据,这些数据将用在校准附件321连同VT/CFC 303一起进行的校准操作中。后面还将结合图23描述校准操作和校准数据源。另外,非易失性存储器(NVM)105X还储存错误编码,该错误编码用在由系统控制器(SC)302控制的掉电操作中。
图8表示Y轴控制器和放大器(YCA)310,它以与图7中XCA 305相同的方式工作。YCA 310接受来自Y轴磁场传感器阵列312、313及温度传感器阵列311、314测得的数据信号并对其进行放大。微控制器102Y根据这些测得的数据执行一个程序,以产生位置反馈,所述位置反馈经系统总线328被输送给VT/CFC 303及其它系统部件。微控制器102Y还经系统总线328接受来自VT/CFC 303及其它系统部件的数据,并根据这些数据生成指令,所述指令控制外电磁体132Y、138Y的励磁,以对实际导管顶端在Y轴方向上的位置产生影响。YCA 310还生成误差信号及修正信号,这些信号将用在校准过程和系统正常工作过程中。下面对这些功能进行描述。
首先说明YCA 310对来自MFS阵列312、313及温度传感器阵列311、314的测量数据的监测方法。磁场传感器阵列312包括传感器113Y、114Y、115Y、116Y。磁场传感器阵列313包括传感器117Y、118Y、119Y、120Y。温度传感器阵列311包括传感器122Y、123Y、124Y、125Y。温度传感器阵列314包括传感器126Y、127Y、128Y、129Y。图13示出这些传感器的实体位置以及相互的位置关系。
微控制器102Y所执行的数学程序可以结合图18、18A、18B和18C予以描述。所述数学程序根据来自传感器阵列312及313的输入数据计算输出的位置数据。在系统运行过程中,该输入及输出数据都储存在随机存取存储器(RAM)103Y中。诸如温度补偿系数等数据则储存在非易失性存储器(NVM)105Y。该补偿系数于温度传感器阵列311、314测得的温度数据一起用于对来自磁场传感器113Y、114Y、115Y、116Y、117Y、118Y、119Y、120Y的数据进行必要的修正。
由解码逻辑106Y连同地址锁存器111Y触发所述测量数据的收集,所述锁存器111Y使微控制器102Y能够设置模拟多路转换器112Y的输入通道。同样,解码逻辑106Y连同地址锁存器109Y使微控制器102Y能够设置可编程放大器110Y的增益,以补偿来自传感器阵列311、312、313和314的信号的强度变化。微控制器102Y通过解码逻辑单元106Y选通采样/保持电路108Y,因此微控制器能够在执行其它功能的同时周期性地采集暂存在采样/保持电路108Y中的数据。因此,采样/保持电路108Y的输出便是待测量信号的一个“瞬象”。
微控制器102Y通过解码逻辑单元106Y向模数变换器(ADC)107Y发出变换指令,将来自位置传感器312、313的模拟信号变换成数字数据,使数码系统能够判读该信号。完成变换时,模数变换器107Y通过解码逻辑单元106Y阻断微控制器102Y,而由微控制器102Y输入测量信号的数码表示。本发明就是以这样的方式对磁场传感器113Y、114Y、115Y、116Y、117Y、118Y、119Y和120Y以及温度传感器122Y、123Y、124Y、125Y、126Y、127Y、128Y和129Y进行监测的。与此相似,还测量分流线路131Y、137Y两端的电压降,以确定通过电磁体132Y、138Y的电流。
再参照图8,电流电源121Y用于提供控制电流,以偏置磁场传感器113Y、114Y、115Y、116Y、117Y、118Y、119Y和120Y。这是因为这些传感器在恒定电流模式下工作情况最好,因此要求电流稳定以可靠地工作。温度传感器的偏置电源130Y用于向温度传感器122Y、123Y、124Y、125Y、126Y、127Y、128Y和129Y提供偏置电压。
以下描述YCA 310生成指令以控制实际导管顶端沿Y轴方向运动的方法。微控制器102Y经系统总线328接受来自VT/CFC 303其它系统部件的数据,并根据这些数据生成控制实际导管顶端沿Y轴方向运动的指令。微控制器102Y连同解码逻辑106Y控制调制器144Y及146Y,产生适宜的运动信号及指令。前置放大器143Y及145Y放大调制器的输出,并驱动末级放大器135Y、136Y、141Y和142Y。二极管133Y、134Y、139Y和140Y的用途为保护末级放大器免受反向电动势浪涌的冲击。所述电动势浪涌是由电磁体线圈132Y、138Y的电感特性引起的。电磁体线圈132Y、138Y产生一个磁场,该磁场对实际导管顶端377在Y轴方向上的位置产生影响。
微控制器102Y经系统总线328和VT/CFC 303及其它系统部件进行通信联系的方式在于:微控制器102Y对解码逻辑106Y设置适宜的地址及控制码位,所述解码逻辑106Y启动地址缓冲器148Y及数据缓冲器147Y。
非易失性存储器(NVM)105Y还储存校准数据,这些数据将用在校准附件321连同VT/CFC 303一起进行的校准操作中。后面还将结合图23描述校准操作和校准数据源。另外,非易失性存储器(NVM)105Y还储存错误编码,所述错误编码用在由系统控制器(SC)302控制的掉电操作中。
图9示出Z轴控制器和放大器(ZCA)315,该控制器和放大器(ZCA)315按与图7的XCA 305相似的方式工作。ZCA 315接受来自Z轴磁场传感器阵列312、313及温度传感器阵列311、314的测得的数据信号,并对其进行放大。微控制器102Z根据这些测得的数据执行一个程序,产生位置反馈,这一位置反馈经系统总线328被输送给VT/CFC 303及其它系统部件。微控制器102X还经系统总线328接受来自VT/CFC 303及其它系统部件的数据,并根据这些数据生成指令,控制对外电磁体132Z、138Z的励磁,以对实际导管顶端337在Z轴方向上的位置产生影响。所述ZCA 315还生成误差信号及修正信号,这些信号将用在校准过程和系统正常工作过程中。下面对这些功能进行描述。
首先说明ZCA 315对来自MFS阵列317、318及温度传感器阵列316、319测得的数据的监测方法。磁场传感器阵列317包括传感器113Z、114Z、115Z、116Z。磁场传感器阵列318包括传感器117Z、118Z、119Z、120Z。温度传感器阵列316包括传感器122Z、123Z、124Z、125X。温度传感器阵列319包括传感器126Z、127Z、128Z、129Z。图13中示出这些传感器的实体位置以及相互位置关系。
可以结合图18、18A、18B和18C描述微控制器102Z所执行的数学程序。所述数学程序根据来自传感器阵列317及318的输入数据计算输出的位置数据。在所述系统运行的过程中,该输入及输出数据都储存在随机存取存储器(RAM)103Z中。诸如温度补偿系数等数据则储存在非易失性存储器(NVM)105Z,该补偿系数和温度传感器阵列316、319测得的温度数据一起用于对来自磁场传感器113Z、114Z、115Z、116Z、117Z、118Z、119Z、120Z的数据进行必要的修正。
由解码逻辑106Z连同地址锁存器111Z触发检测数据的收集,该锁存器111Z使微控制器102Z能够设置模拟多路转换器112Z的输入通道。同样,解码逻辑106Z连同地址锁存器109Z使微控制器102Z能够设置可编程放大器110Z的增益,以补偿来自传感器阵列317、318、316和319信号强度的变化。
微控制器102Z通过解码逻辑106Z选通采样/保持电路108Z,因此,微控制器能够在执行其它功能的同时周期性地采集暂存在采样/保持电路108Z中的数据。因而,采样/保持电路108Z的输出便是待测量信号的一个“瞬象”。微控制器102Z通过解码逻辑单元106Z向模数变换器(ADC)107Z发出变换指令,将来自位置传感器317、318的模拟信号变换为数字数据,使数码系统能够判读该信号。完成变换时,模数变换器107Z经解码逻辑单元106Z阻断微控制器102Z,而由微控制器102Z输入测量信号的数码表示。本发明就是按这样的方式监测磁场传感器113Z、114Z、115Z、116Z、117Z、118Z、119Z和120Z以及温度传感器122Z、123Z、124Z、125Z、126Z、127Z、128Z和129Z的。与此相似,还对分流线路131Z、137Z两端的电压降进行测量,以确定通过电磁体132Z、138Z的电流。
参照图9,电流源121Z的用途是提供控制电流,以偏置磁场传感器113Z、114Z、115Z、116Z、117Z、118Z、119Z和120Z。这是因为这些传感器在恒定电流模式下工作情况最好,因此要求电流稳定以可靠地工作。温度传感器的偏置电源130Z的用途是向温度传感器112Z、123Z、124Z、125Z、126Z、127Z、128Z和129Z提供偏置电压。
以下描述ZCA 315生成指令以控制实际导管顶端沿Z轴方向的运动的方法。微控制器102Z经系统总线328接受来自VT/CFC 303及其它系统部件的数据,并根据这些数据生成控制实际导管顶端沿Z轴方向运动的指令。微控制器102Z连同解码逻辑106Z控制调制器144Z及146Z,产生适宜的运动信号及指令。前置放大器143Z及145Z放大调制器的输出,并驱动末级放大器135Z、136Z、141Z和142Z。二极管133Z、134Z、139Z和140Z的用途为保护末级放大器免受反向电动势浪涌的冲击,所述电动势浪涌是由电磁体线圈132Z、138Z的电感特性引起的。电磁体线圈132Z、138Z产生一个磁场,该磁场对实际导管顶端在Z轴方向上的位置产生影响。
微控制器102Z经系统总线328和VT/CFC 303及其它系统部件进行通信联系的方式在于:微控制器102Z对解码逻辑单元106Z设置适宜的地址及控制码位,该解码逻辑单元106Z启动地址缓冲器148Z及数据缓冲器147Z。
非易失性存储器(NVM)105Z还储存校准数据,这些数据将用在校准附件321连同VT/CFC 303一起进行的校准操作中。后面还将结合图23描述校准操作和校准数据源。另外,非易失性存储器(NVM)105Z也储存错误编码,该错误编码用在由系统控制器(SC)302控制的掉电操作中。
图10示出通信控制器(CC)320,其主要功能为通过系统总线328与系统的其它部件通信联系。为了保持实际导管顶端在患者体内的位置,当系统正在工作时,将来自XCA 305、YCA 310及ZCA 315的位置数据储存在随机存取存储器(RAM)156中;当系统掉电时,将这些位置数据储存在非易失性存储器(NVM)154中。微控制器149经系统总线328和其它系统部件进行通信联系。通信联系时可以向解码逻辑单元153设置适宜的地址及控制码位,以启动地址缓冲器150及数据缓冲器151。与此相似,微控制器149通过通信I/O接口152和PC324、辅助设备322及主机系统323进行通信联系。通信联系时可以向解码逻辑153设置适宜的地址及控制码位,或响应来自接口152的阻断信号。这样做有许多原因,比如需要将实际过程及手术程序显示在CRT显示器上。
图11表示校准附件(CF)321的电路图。图12表示校准附件(CF)321的机械部分。所述CF321的用途是确定虚拟顶端405沿各个可能方向的运动步骤及界限。将这种运动步骤及界限信息传输给VT/CFC 303,用以在GCI装置501正常工作期间使电路和实体操作能够同步地工作。
可以沿着5个可能的轴线操纵校准磁体411,这些轴线定义为X轴406、Y轴407、Z轴408、θ轴409及EL轴410。这些轴准确地对应于虚拟顶端405的5个可能运动方向,这也是实际顶端377的可能自由度的最大值。由如图11所示校准附件321的电路实现对校准磁体411的操纵。
图11所示电路的工作情况如下:解码逻辑单元101C响应来自VT/CFC303的地址及控制码位,启动数据缓冲器51C并设定它的方向。在被解码逻辑101C选通时,步进锁存器52C、53C储存这些数据,这些数据准备发送给步进驱动器54C、56C、58C、60C和62C。步进电机55C、57C、59C、61C和63C响应该步进驱动器的输出,并在5个轴线上驱动磁性校准顶端。绝对编码器64C、66C、68C、70C和72C与相应的步进电机机械地相耦接,并向VT/CFC 303提供位置反馈信息。编码器64C、66C、68C、70C和72C的输出受到数据缓冲器65C、67C、69C、71C和73C的缓冲,以暂时储存并传输这些数据。限止“开关”74C、75C、76C、77C、78C和79C给三个轴线X、Y及Z作上终端标记。当角度θ及EL为0时,“开关”80C及81C发出指示。当被解码逻辑101C选通时,锁存器82C便储存这些数据。
图13示出电磁体132X、132Y、132Z、138X、138Y、138Z、磁场传感器和温度传感器对350、351、352、353、354、355、356、357、358、359、360、361、362、363、364、365、366、367、368、369、370、371、372及373的极性配置结构374。电磁体132X、132Y、132Z排列在三个取向轴X、Y、Z上,或者如图13A、13B所示。
图13A及图13B表示成簇构造的磁性体,其中,近似地示出工作台389和电磁体901、902、903及904、905、906的相对关系,并示出将这些部件安装在C形臂结构的支承组件391上,构成封闭磁路,并且互相让开的情况。还可以将极性配置结构374表达为一个非对称的极性分布,其中电磁体901和它的相对置的电磁体903转过一定角度,形成呈瓣形的电磁场。这样的排列方式进一步优化了磁路,并使医生和患者得以自由的接近,同时Z轴的电磁体905及906也不会妨碍有效接近空间,如图13及图16所近似地表示的那样。另外,可以用图16及图16A、16B、16C所示的双平面环构造替代图13及图13A、13B中的互相让开的构造。对于诸如X射线、Cat-Scan、Pet-Scan、超声等各种不同成像程式来说,这两种构造代表能够适应这些成像程式的可能途径,尽管图16在双平面构造上向GCI装置501设置了用于荧光成像的固有进入通道。如图13、13A及13B的几何关系具有一个约25英寸的空间,可使该空间与一个计算机层断装置和/或上面所述的各种成像程式相结合。更多的利用这种几何布局的实施例展示在图13A、13B中,并在下面对图13C、13D、13E、13F、13G及13H的描述中予以解释。图16、16A、16B、16C和图13A、13B所示的两种互相竞争的结构形式在安装操作界面设备500、外科医疗设备502及GCI装置501方面各有其优点及缺点。图13A及13B还示出一个关于螺旋线圈在C形臂及工作台389上安装的替代构造。按照这种构造,线圈901至906被集束成簇。这种几何布局是从线圈的一种直观的正交构造演变来的,这种线圈构造被普遍应用在以电磁线圈来生成矢量或矢量梯度的场合下。图13B中的6个线圈901至906排列成花瓣形或是排列成一束。其中三个线圈被安装在C形臂的顶部,另外三个被安装在底部。顶部的三个线圈和底部的三个线圈同样都是相互夹120°角。另外,顶部的三个线圈稍稍向下倾斜约15°到20°角,而底部的三个线圈稍稍向上倾斜约15°到20°度角,如图13B所示那样。另外,顶部的三个线圈相对于底部的三个线圈偏转60°角。
图13B中位于C形臂391顶部的三个线圈的标号按顺时针次序为901、902、903;而位于底部的线圈标号按逆时针次序为904、905、906。线圈901及903成对工作,被称为X轴线圈对,线圈902和904是另两个成对工作的线圈,被称为Y轴线圈对,而线圈905、906是第三对成对工作的线圈,被称为Z轴线圈对。
图13C、13D、13E、13F、13G和13H示出GCI装置501的一种可供选择的替代构造,从而,使图16、16A、16B及16C所示的极性配置结构被选择为适应图13A及13B所示的电磁线路的集束构造。图13C表示该系统各个部件的简单方块图。该系统包括电源910、游戏杆(joystick)900、三个送进通道X、Y、Z。本文所取三个信号一起组成矩阵V923。图13D中表示,所述矩阵V 923包含元素Vjx、Vjy、Vjz。这种构造在图13D、13E、13F、13G及13H中另有描述。在图13C中,X轴通道包括运算放大器(Op-Amp)911、电流放大器910、一对线圈901、903;Y轴通道包括运算放大器(Op-Amp)913、电流放大器912、一对线圈902、904;Z轴通道包括运算放大器(Op-Amp)915、电流放大器914、一对线圈905、906。由图可见,每一对线圈都串联连接后再分别连到X、Y、Z轴的功率放大器910、912及914的输出端。图13C所示的用来替代图1的构造接受来自游戏杆900的输入指令信号。当操作者通过游戏杆900发出沿着一个或多个轴线运动的指令时,游戏杆900便将该信号发送到分别对应于X、Y、Z轴的运算放大器911、913、915阵列。运算放大器911、913、915将来自游戏杆900的信号进行转换,并对该三个轴的三个信号的矩阵实行逆运算。运算放大器阵列932将以矢量V923表示的来自游戏杆900的信号乘上另一个矩阵M-inverse,该矩阵M在图13F及13G中的标号为927。这样,运算放大器阵列932的输出是M-inverse乘V,这里M是6个线圈901至906的成簇构造的特征矩阵925。于是,得到包括运算放大器911、913、915的运算放大器阵列932的输出。将该输出发送到功率放大器910、912、914,以驱动6个线圈901至906,结果,产生所需方向的运动。这样,GCI装置501便能够将操作者或是临床医生对于导管顶端377运动的要求转换成该导管顶端377在患者390体腔内的运动。图13D、13E、13F及13G所示的示意图可使图13H被进一步简化,这里,将来自游戏杆900的输入信号V 931发送给一个Mchar-inverse的运算放大器阵列932。阵列932的最终输出是Mchar-inverse乘矢量V的矩阵乘积。将该输出信号发送到电流放大器928,以矢量B 933表示该放大器的输出信号,代表分别输送给各个线圈901至906的电流。这样,该装置便将临床医生的手的动作转换成适宜的信号,并使导管顶端运动到所需的位置。
总的来说,上述替可供选择的结构向GCI装置501提供一种方法,其中采用一种备选构造可以替代图1所示的构造,这里,通过使用图13H所示原理,使各线圈的非对称布置线性化,从而产生所需的结果。图13E中示出这一点。
图14表示传感器阵列306、307、308、309、311、312、313、314、316、317、318和319中的磁场传感器和温度传感器对的排列情况。每个正交轴上同轴地布置了第一、第二两个电磁体,从而被分成两个磁极。例如,电磁体132X和138X同轴,电磁体132Y和138Y同轴,电磁体132Z和138Z同轴。由于由θ和EL定义的虚拟顶端405的旋转运动分别发生在X—Y和X—Z平面上,如图6所示,因此沿着X、Y、Z三个轴的各个电磁体的磁极足以促使实际导管顶端377准确地在相应的5个轴方向上运动。这5个轴便是前面结合图6所述的虚拟顶端405运动的5个轴。
在一个实施例中,MFS阵列307、308、312、313、317和319中包含的每一个磁场传感器都和温度传感器阵列306、309、311、314、316和318中的每一个温度传感器(TS)配成对。这些配对结合在图14及下面的表格中都有详细描述。这些磁场传感器-温度传感器对(MFS/TS)排列在电磁体132X、132Y、132Z、138X、138Y、138Z的极面上的各象限内。
如图13所示,MFS/TS对350、351、352和353排列在电磁体132X极面上的各象限内。磁场传感器和温度传感器(TS)对354、355、356和357排列在电磁体138X极面上的各象限内。磁场传感器和温度传感器(TS)对358、359、360和361排列在电磁体132Y极面上的各象限内。磁场传感器和温度传感器(TS)对362、363、364和365排列在电磁体138Y极面上的过象限内。磁场传感器和温度传感器(TS)对366、367、368和369排列在电磁体132Z极面上的过象限内。磁场传感器和温度传感器(TS)对370、371、372和373排列在电磁体138Z极面上的过象限内。
图14所示为如图13那样安装的磁场传感器及温度传感器的配对情况。图中,磁场传感器和温度传感器都被安排为等温的对,各个对互相联合发挥作用。磁场传感器的功能是测量实际顶端377在选定测量时段中的位置。该选定测量时段分别由XCA 305、YCA 310、ZCA 315中的微控制器102X、102Y、102Z来控制。在该选定时段中,电磁体132X、132Y、132Z和138X、138Y、138Z都没有励磁。之所以选定这样的时段来进行测量,是为了使电磁场传感器阵列307、308、312、313、317、318能够进行准确而灵敏的测量。反之,如果测量时段选在进行励磁的时候,这些传感器将被电磁体的磁通量所饱和。温度传感器阵列306、309、311、314、316和319的功能是对环境温度进行监测,以探测出可能使患者不舒适和可能损害周围组织的温升,并且给出根据磁场传感器数据进行位置计算所用的修正数据。这些等温对如下:
磁场传感器113X和温度传感器(TS)122X构成对350。磁场传感器114X和温度传感器(TS)123X构成对351。磁场传感器115X和温度传感器(TS)124X构成对352。磁场传感器116X和温度传感器(TS)125X构成对353。磁场传感器117X和温度传感器(TS)126X构成对354。磁场传感器118X和温度传感器(TS)127X构成对355。磁场传感器119X和温度传感器(TS)128X构成对356。磁场传感器120X和温度传感器(TS)129X构成对357。磁场传感器113Y和温度传感器(TS)122Y构成对358。磁场传感器114Y和温度传感器(TS)123Y构成对359。磁场传感器115Y和温度传感器(TS)124Y构成对360。磁场传感器116Y和温度传感器(TS)125Y构成对361。磁场传感器117Y和温度传感器(TS)126Y构成对362。磁场传感器118Y和温度传感器(TS)127Y构成对363。磁场传感器119Y和温度传感器(TS)128Y构成对364。磁场传感器120Y和温度传感器(TS)129Y构成对365。磁场传感器113Z和温度传感器(TS)122Z构成对366。磁场传感器114Z和温度传感器(TS)123Z构成对367。磁场传感器115Z和温度传感器(TS)124Z构成对368。磁场传感器116Z和温度传感器(TS)125Z构成对369。磁场传感器117Z和温度传感器126Z构成对370。磁场传感器118Z和温度传感器(TS)127Z构成对371。磁场传感器119Z和温度传感器(TS)128Z构成对372。磁场传感器120ZX和温度传感器(TS)129Z构成对373。
图15及15A表示一种与GCI装置501一起使用的改进型导管组件375及导向线组件379。导管组件375是一管形工具,该导管组件375包括导管体376,导管体376延伸到一个柔软段378,该柔软段378具有较大的柔性,使得具有较大刚性,并且能够响应外界控制的顶端377得以准确地被引导通过曲折的路径。
该磁性的导管组件375和GCI装置501结合在一起能够减少甚至免除诊断或治疗程序通常需要的过多形状的导管工具。这是由于在传统的插管程序中,因为整个过程都是手工操作的并主要依赖手工技巧来操纵导管通过诸如心血管系统那样的曲折路径,因此,外科医生经常难以将常规的导管导引到所需位置上。由于一个患者体内或不同患者之间的解剖学构造的多样性,因此在不同的情况下需要用许多不同的弯管来应付,于是,便制造出过多的各种各样尺寸及形状的导管提供给外科医生,以帮助他们。
通过使用GCI装置501,由于是在一套机电系统的帮助下完成插管过程的,于是,对于大多数患者,如果不是所有患者的话,只需要单独一个导管。所述机电系统使外科医生能够通过对一个虚拟顶端405的操作,来操纵导引磁性导管及导向线组件375、379进入到患者390体内的所需位置,而不需要医生盲目地将导管推入患者体内。由于医生在通过手工将实际导管顶端377推进通过患者体腔过程中所可能遇到的困难中的大多数困难都可以借助于GCI装置501来克服(即该磁性顶端能够被电磁体132X、132Y、132Z吸引或排斥),因此说,磁性导管和导向线组件375、379具有很大的适应性来通过各种曲折路径。
导向线组件379是一种包括导向线本体380及一个柔性段382的工具,该柔性段382具有足够的柔性,使得刚性相对较大地响应顶端381,得以准确地绕过剧烈弯曲段而被导引通过曲折的路径。所述响应顶端377、381分别属于导管组件375和导向线组件379,这两个顶端377、381都包括一个诸如永久磁体那样的磁性元件,该永久磁体响应电磁体132X、132Y、132Z以及138X、138Y、138Z所产生的外部磁通量。
导管组件375的响应顶端377是管形的,而导向线组件379的响应顶端381则是实心的圆柱体。导管组件375的响应顶端377是一个二极磁体,由纵向取向的磁性元件的两端形成。导向线组件379响应顶端381是一个由纵向取向的磁性元件的两端所形成的的二极磁体。由于电磁体132X、132Y、132Z以及138X、138Y、138Z所产生的磁通量将会作用在该顶端377、381上,并在操作者的操纵下将它们均匀地“拖”到所需位置处,因此,这两个纵向二极磁体377及381使得GCI装置501能够对它们进行操纵。
图15B所示为另一个用以与GCI装置501一起使用的改进型导管组件375及导向线组件379。其中导管组件950上附着了一个另加的如图所示位置的压电环951及952。超声检测器可以和GCI装置501一起作为这种导管顶端的另一种检测方式。该检测方式通过发射一种超声信号刺激两个压电环,以测量导管顶端相对于磁体377的北极轴线的转动。在计算机324的帮助下,GCI装置501便能够确定顶端377的转动角。根据本专业公知的更为复杂的电路,如图17及17A所示,压电环951、952能够提供更多的位置信息,以确定导管顶端377相对于立体框架的位置、取向和转动数据。
图16所示为一种与图1所示装置结合的双平面X射线环。图16A、16B及16C是比图16更精细的图,图中示出图16所不能显示的更多细节及元件,或者为了清楚起见,而省略了一些图16中已经显示的内容。图16A、16B和16C分别是相对于电磁体及成像组件391及支承组件385的俯视图、端向视图和侧视图。
图16进一步示出:工作台389、患者390、T-轴编码器394、耳轴388、支承组件385、极面支承391、G-轴编码器393、X射线源383、图像增强器384、电磁体132X、132Y、132Z;电磁体138X、138Y、138Z、电源及控制系统392、辅助设备322、主机系统323、PC机324、虚拟顶端组件304、校准附件321、鼠标327、键盘326、监视器325之间的总体关系。其中电磁体132X、132Y、132Z、138X、138Y、138Z的总体排列如极性配置结构374。为了便于观看,这些部件在图中的位置是近似的。这些部件的功能,凡是至今尚未描述的,将在下面的篇幅中结合图16、16A、16B和16C解释。
T-轴编码器394及G-轴编码器393向系统提供龙门架的位置信息,用来在电磁体励磁之前计算要求的坐标旋转角。耳轴388的作用是作为支承组件385的一个支托。极面支承391绕着支承组件385的G-轴旋转。极面组件391支托着X射线源383及X射线图像增强器384,这两个部件产生的图像将和实际导管位置叠加在一起显示在操作者界面500的监视器325上。极面支承391作为一个安装面用来将电磁体132X、132Y、132Z、138X、138Y、138Z保持在如图13所示的合适的同轴排列位置上。
耳轴388和图16A中的T-轴重合。图中的T-轴编码器394和耳轴388机械相连以对位于T-轴上的支承组件385的位置数据进行编码。图16A中的万向轴(G-轴)和T-轴387在极面支承391的中心点处相交。该中心点准确地和X射线视野的中心点重合。图中的G-轴编码器393和沿着G-轴386转动的支承组件385机械相连。这些部件的功能将在下面篇幅中加以描述。
图16所示的X射线支承组件385和391被设计成在前后投射方向上有20°的尾部成角(caudal angulation—AP尾)。图17所示为GCI装置501和电影血管造影设备502的总的连接情况。电影血管造影设备502通过操作者界面500和GCI装置501相连。视频监视器325上显示的是一个树枝状动脉的电影血管造影图像和所叠加的显示导管顶端377位置的X射线图像。这两个图像由GCI装置501通过通信控制器320来使其同步地显示在操作者界面500的监视器325上。
图17A中示出一个立体的框架,以定义导管顶端相对于该框架的位置。这种方法利用一个近似的立方体来形成基准标记。
下面提供的方法用来截获X射线装置和/或超声成像技术生成的透视图像,以产生参考标记,这种参考标记用于对GCI装置生成的导管顶端或导向线的图像进行同步。所述方法将所截获的图像重叠并动态链接到一个以数字代表的基准标记上,产生一个和体内所感兴趣部位一致运动的图像。例如,搏动的心脏及其心电图输出、肺的膨胀及收缩、或患者的抽搐等都可以动态地截获并与其链接起来以使导管的顶端和体内所讨论的器官一致运动。
图17A还示出所述图像截获技术。这种技术将如图17所示生成的基准标记700A1、700A2、700A3、700A4、700B1、700B2、700B3及700B4叠加到X射线/超声透视图像上。所提出的方法使操作者可以参照X射线/超声图像识别导管顶端377的动态位置。可以由基准标记700Ax形成的参考框解释导管顶端相对立体框架的位置。另外,通过使用一种几何投影技术,该方法提供了和导管顶端377同步的图像截获技术,该技术能够将X射线/超声图像和基准标记及导管顶端三者动态地叠加在一起,从而可以以一个参考框架来定义位置。
图17B所示系将一带有电极的心脏起搏器801植入到相对于S.A.节点802、A.V.节点803和房室束804区域的情况。从该图还可以见到左、右束支805。植入起搏器是使心脏节律或传导紊乱的患者得以存活的重要手段。这个医疗程序是将一个小型电极植入患者的心腔(心室或心房)壁内。电极的另一端和植入在胸部皮肤下的一个电子器件相连,该电子器件发出刺激脉冲来刺激心脏的节律。同样,当电极(例如一个可植入的自动心脏去纤颤器(AICD))检测到患者发生威胁生命的电紊乱时,可以相似的电器件对患者施加电冲击。这些电极都可通过静脉在X射线照射下手工操作推入。使用本发明所建议的GCI装置501及附有磁性顶端381的导向线379,可以通过本发明描述的方法及装置将起搏器801的电极送进并放置到合适的位置上。通过基准标记700A1、700A2、700A3、700A4、700B1、700B2、700B3及700B4,医生可以将导向线379导引通过心脏内腔,同时伴随有一个如图17及17A所示的连续而动态地识别导向线顶端381位置的参考框。许多情况下,由于解剖学上的差异,手工操作难以将电极安放到合适位置上,结果达不到最佳效果。本发明的GCI装置501能够简单地实施如此复杂的操作,并使医生能够将起搏器801的电极送进、并放置到准确的解剖学位置上,而不会由于导航、导引、控制及对导向线及起搏器电极的运动进行准确成像等方面的困难而被迫采取退让措施。
前面已经描述了GCI装置501的各个部件。现在将结合图18至23描述实际导管顶端377的位置控制、虚拟顶端405的位置调整,以及实际导管顶端377的新位置的计算这三者之间的数学关系及GCI装置501的总的工作过程。
电源接通后,装在监管单元(SU)301、系统控制器(SC)302、X轴控制器和放大器(XCA)305、Y轴控制器和放大器(YCA)310、Z轴控制器和放大器(ZCA)315、通信控制器(CC)320、计算机324,以及虚拟顶端/校准附件控制器(VT/CFC)303内的机内测试程序执行一系列自我诊断测试。另外,一些测试项目将在背景里连续进行,所述背景测试项目比如包括:直流电源的电压及电流监测,交流电压及电流监测,以及通信联系测试。这些背景测试以对于操作者透明的方式和系统的正常功能交叉进行。
测试程序的执行结果报告给系统控制器(SC)302。系统控制器(SC)302将这些结果与储存在非易失性存储器(NVM)39(图3)中的相应期望值进行比较。当测试到存在故障或任何不正常现象时,系统控制器(SC)302对情况的严重程度进行判断。如果存在不可纠正的状况,系统控制器(SC)302便以合适的方式来断开电源。如果所存在的问题有可能得到缓和或消除,系统控制器(SC)302便指令计算机324发出报警声音信号并指令监视器325显示出差错提示符。任何检测到的故障还作为一个故障编码储存到非易失性存储器(NVM)39中以供日后回顾及故障检修用。
在一个实施例中,虚拟顶端405及校准附件(CF)321(图5、6、11和12)在X、Y、Z轴方向上各有8英寸的冲程。这相当于极性配置图374(图13)上的8英寸×8英寸×8英寸控制区域。虚拟顶端405和校准附件321还在θ轴和仰角(EL)轴上可以旋转360°。
一旦校准附件(CF)321及虚拟顶端405在X、Y、或Z轴上作8英寸的偏移,步进电机55C、57C、59C、61C和63C和所带的编码器64C、66C、68C、70C和72C便旋转。步进电机55C、57C、59C、61C和63C的分辨率比如为约,每转400个半步,相当于位置分辨率0.022英寸(≈0.56毫米)。另外,编码器的分辨率可以为约每转512比特,这相当于测量分辨率0.015625英寸(≈0.397毫米)。在θ及EL轴上,步进电机的分辨率可以为约0.9°而编码器的分辨率可以为约0.703125°。
校准过程中,将校准附件(CF)321置于极性配置结构374,并与虚拟顶端/校准附件控制器(VT/CFC)303相连。然后,虚拟顶端/校准附件控制器(VT/CFC)303发出编码,以驱动步进电机55C、57C、59C、61C和63C,带动校准附件(CF)321。然后,校准附件(CF)321读取编码器64C、66C、68C、70C和72C,确定磁体411的现有位置及取向。然后将自编码器读取的位置数据以及从磁场传感器307、308、312、313、317和318(图1、7、8、9)推导所得的位置数据进行比较。这时,磁场传感器307、308、312、313、317和318的响应所代表的是磁体411,也是磁性导管顶端377的满行程位置及满行程取向。
正常工作期间,虚拟顶端405和虚拟顶端/校准附件控制器(VT/CFC)303相连。操纵虚拟顶端405时,虚拟顶端/校准附件控制器(VT/CFC)303读取编码器64、66、68、70和72。所读得的位置数据被系统控制器302用来当作实际顶端(AT)的要求位置(DP),并按图23所述定义,控制实际顶端(AT)的运动。
图13中的电磁体132X、132Y、132Z、138X、138Y、138Z将在实际导管顶端377及导向线组件顶端381(图15及15A)上产生一个合力。可以用给定大小及方向的矢量B600表示该合力。图18所示为该合力矢量B及其各个组成矢量。矢量B是当XCA305、YCA310、ZCA315发出运动指令时的6个电磁体132X、132Y、132Z、138X、138Y、138Z所发出的力的矢量的合力矢量。矢量Bx601是矢量B600在X轴上的投影,矢量By602是矢量B600在Y轴上的投影,矢量Bz603是矢量B600在Z轴上的投影。而α角604、β角605、δ角606则分别是矢量B600和矢量Bx 601、矢量B600和矢量By 602和矢量B600和矢量Bz 603之间的夹角。
如前面所述,图18中电磁场产生的合力矢量B600的大小为
B = Bx 2 + By 2 + Bz 2
它的方向由下述三个角度给出:
α=cos-1Bx,β=cos-1By,δ=cos-1Bz
合力矢量B是通过系统控制器102根据下列因素发出指令而产生的:1)来自磁场传感器阵列307、308、312、313、317和318并且经过XCA301、YCA310、ZCA315处理的关于实际导管顶端37在患者390体内的位置的输入参数;以及2)由虚拟顶端405的位置表示的实际导管顶端377的所需位置,这个所需的位置来自VT/CFC303的输出。微控制器33对一个储存在系统控制器302的ROM 40(图3)中的编码进行处理,产生矢量B 600的各个组成矢量Bx 601、By 602和Bz 603。各个组成矢量的大小都将转发给合适的XCA 305、YCA310和ZCA315,以改变调制器的输出,并转而改变电磁体132X、132Y、132Z、138X、138Y、138Z产生的电磁场。这样,便分别由X轴、Y轴及Z轴方向上的磁通量来实现所述组成矢量Bx、By和Bz,并且,由此而在实际导管顶端377上产生一个合力B 600,这个合力B 600有效地将实际导管顶端377拉曳到所需的位置处。
然后,确定实际导管顶端377的新位置,以证实该顶端377是否确实位于所需的位置上,或是是否需要作进一步的调整,或是该顶端377遇到了阻碍。下面结合图18A至图22说明系统控制器302来确定实际导管顶端377新位置的方法。
图18A、19和19A以及下面的讨论中,各个变量将以下列记号表示,其中:
aN——实际导管顶端的磁性元件的远端,图18A中表示为北极(North dipole)。
aS——实际导管顶端的磁性元件377的近端,图18A中表示为南极(sorth dipole)。
aD——实际导管顶端磁体377的长度,等于aS和aN之间的距离(见图18A)。
XD——同轴的相对两极沿着X轴方向的距离,亦即电磁体132X及138X的极面之间的距离(参见图19中的标号616)。
-x1、-x2、-x3、-x4——分别表示MFS和TS对354、355、356、357(见图13及19A)。
d——各个相邻MFS/TS对之间的距离,亦即MFS/TS对354和MFS/TS对355之间的距离,以及MFS/TS对355和MFS/TS对356之间的距离等(参见图19A)。。
x1、x2、x3、x4——分别表示MFS和TS对350、351、352、353(参见图13及19A)。
ROT——X-Y平面上的旋转角θ(图21中的参考标号625)。
ELEV——X-Z平面上的仰角EL(图22中的参考标号626)。
由图13中的电磁体132X、132Y、132Z、138X、138Y、138Z所引起的电磁场在实际导管顶端377及导向线顶端381上产生一个合力。可以用一个给定大小和方向的力矢量表示该合力,并和它的组成矢量一起被示于图18中。矢量B 600是当XCA301、YCA310、ZCA315发出运动指令时6个电磁体132X、132Y、132Z、138X、138Y、138Z一起发出的力矢量的合成矢量。矢量Bx 601是矢量B 600在Z轴上的投影,矢量By 602是矢量B600在Y轴上的投影,矢量Bz 603是矢量B 600在Z轴上的投影。角度α 604、β 605和δ 606相应为矢量B和Bx、B和By、B和Bz之间的夹角。
图18A表示磁性导管顶端607的一个实施例。该磁性顶端607相当于导管组件375的响应顶端377和导向线组件379的响应顶端381的组合(图15及15A)。由与一个虚拟环608相连的两个磁极aN607A及as607B表示磁性顶端607。由虚拟顶端(VT)405在X轴400、Y轴401及Z轴402(图6)上的行程中心点确定虚拟环608。进行校准时,虚拟环608也和校准磁体411在X轴406、Y轴407及Z轴408(图12)上的行程中心点重合。假定所述虚拟环608位于X射线视野的中心,磁场传感器(MFS)检测电磁体(EM)控制体积(control volume)的体积及中心。进行校准时,所述虚拟环608也和校准附件(CF)在X轴、Y轴及Z轴上的行程的中心点重合。
图18B表示定义导管顶端607的位置的合成位置矢量An 609,由磁场传感器307、308、312、313、317、318检测并由XCA 305、YCA 310、ZCA315的微控制器102x、102y、102z计算得到该位置矢量An 609。组成矢量Xn、Yn、Zn分别是位置矢量An 609在X轴、Y轴、Z轴上的投影。角度α609A、β 609B和δ 609C相应为矢量An609在X轴、Y轴、Z轴上的投影角。这样的正交表示方法相应于图16那样的极性配置374。
图18C所示为导管顶端607的合成位置矢量的三维角度表示。在图18C中,图18B中的位置矢量An 609确定北极aN607A的位置,这是磁性顶端607的两个磁极中的一个极在X-Y平面上的投影。投影矢量θxy615可以按它相对于X轴的角度θx613及其相对于Y轴的角度θy614得以被确定。为了简单起见,图中未予表示该位置矢量An在X-Z及Y-Z平面上的投影,因此,也未示出该矢量An和Z轴612之间的角度关系。位置矢量An的这些角度关系,例如θx613及θy614,可以在计算中用来根据磁场传感器阵列307、308、312、313、317、318的检测数据确定实际导管顶端377的位置aN。下面将说明这种计算。
图19表示电磁体的相对两个磁极和极面间的距离XD 616。在系统工作过程中,可将这个距离XD用于所作的计算中。下面将说明这样的计算。
图19A表示两个邻近的X轴磁场传感器之间,亦就是磁场传感器-X1618和-X2 619之间的距离d 617。图中还示出两个另外的磁场传感器-X3及-X4。磁场传感器-X1、-X2、-X3及-X4分别对应于MFS和温度传感器对354、355、356和357,而磁场传感器X1、X2、X3及X4分别对应于MFS和温度传感器对350、351、352和353。
图20表示所述系统根据磁场传感器X1、X2、X3及X4测得的数据推得磁性顶端607实际位置所用的几何学过程。合成矢量A 620被系统进一步的变换,生成顶端607的位置坐标621及622,从而求出实际顶端377的位置。在下面的讨论中,这种几何学过程将显得更为清楚。
图20A进一步示出根据来自磁场传感器X1、X2、X3及X4的信号,用另外的数学变换及计算,所得出的位置矢量622、621的各个分量。由位置坐标621及622确定所述实际顶端377的位置。图中的位置623是由磁场传感器X1、X2、X3及X4测定实际导管顶端377的测量位置,而位置624是系统控制器302确定的计算位置。在理想情况下,位置623和位置624是互相相等的。
图21表示顶端607绕着Z轴(θ)的旋转625。这一旋转实际上是发生在X-Y平面上的一种弧形运动或摆动。图22所示为顶端607在Z轴上的平移626。
系统控制器(SC)302根据磁场传感器阵列307、308、312、313、317、318所生成的信号推得实际导管顶端377的位置。下面说明这种推得的过程。
图18A、19和19A中,各个变量将以下列记号表示,其中:
aN——北极方向。
aS——南极方向。
aD——顶端磁体的长度。
XD——相对两极132X及138X之间的距离。
-x1、-x2、-x3、-x4——分别表示MFS和TS对354、355、356、357。
d——磁场传感器和温度传感器354和355等之间的距离。
x1、x2、x3、x4——分别表示MFS和TS对350、351、352、353。
ROT——θ轴。
ELEV——E轴。
根据图18A、28B和18C,可由正交矢量aN、AN和as、As确定实际顶端377的位置。这些正交矢量是它们的组成分量x、y和z的合成矢量:
AN=(Xn,Yn,Zn),
其中,Xn,Yn,Zn是正交矢量AN在X,Y,Z轴上的投影(参见图18B),而
As=(Xs,Ys,Zs),
其中,Xs,Ys,Zs分别是正交矢量As在X,Y,Z轴上的投影。
可由下列角度确定正交矢量AN及AS的方向(参见图18B):
α是关于X轴的角度;
β是关于Y轴的角度;
γ是关于Z轴的角度。
同样,图18中还示出矢量B,可由三个角度α、β、γ确定该矢量B。
矢量AN的大小,亦即虚拟坐标原点到点a607A(见图18C)的距离可以下式计算:
a N = Xn 2 + Yn 2 + Zn 2 ,
而且,确定矢量AN方向的各个角度则由下式计算:
α = cos - 1 [ Xn An ] = cos - 1 [ Xn Xn 2 + Yn 2 + Zn 2 ]
β = cos - 1 [ Yn An ] = cos - 1 [ Yn Xn 2 + Yn 2 + Zn 2 ]
γ = cos - 1 [ Zn An ] = cos - 1 [ Zn Xn 2 + Yn 2 + Zn 2 ]
位置矢量AN投影在如图18C所示的三个正交平面X-Y、X-Z、Y-Z上产生的各个平面上的组成矢量及其对应的角度如下:
在X-Y平面上,所投影的矢量θxy关于X轴和Y轴之间的角度(参见图18C)可表示为:
θx = arctan ( Xn Yn ) ,
θy = arctan ( Yn Xn ) ,
其中,投影矢量θxy在X-Y平面上的大小为:
Axy = Xn 2 + Yn 2 .
同样,投影矢量θxy关于X轴和Z轴之间的角度可表示为:
θx = arctan ( Xn Zn ) ,
θz = arctan ( Zn Xn ) ,
并且,投影矢量θxy在X-Z平面上的大小为:
Axz = Xn 2 + Zn 2 .
同样,投影矢量θxy关于Y轴和Z轴之间的角度可表示为:
θy = arctan ( Yn Zn ) ,
θz = arctan ( Zn Yn ) ,
并且,投影矢量θyz在Y-Z平面上的大小为:
Ayz = Xn 2 + Zn 2 .
应予指出,解出AN=(Xn,Yn,Zn)的数学解之后,再解出As=(Xs,Ys,Zs)的数学解。
如图18A所示,如果aN和as之间的距离D 607已知,那么:
D = ( Xn - Xs ) 2 + ( Yn - Ys ) 2 + ( Yn - Ys ) 2
为了说明系统控制器302如何确定实际导管顶端的位置,现在描述XCA305的微处理器102x所用关于X轴及虚拟原点608的计算。应予指出,YCA310及ZCA 315的对应微处理器102y及102z将对生成的关于X轴及Y轴各个位置的数据进行相似的计算。
从校准程序(fx1,fx2,fx3,fx4)可以知道,共面磁场传感器(x1,x2,x3,x4)的传递函数,有如图20所示者,它们是:
-X1=—(V-x1(f-x1))               +X1=—(V-x1(f-x1))
-X2=—(V-x2(f-x2))               +X2=—(V-x2(f-x2))
-X3=—(V-x3(f-x3))               +X3=—(V-x3(f-x3))
-X4=—(V-x4(f-x4))               +X4=—(V-x4(f-x4))
按装在电磁体138X极面上的各MFS/TS对354、355、356、357都将给XCA 305的处理器102X提供位置数据。从比如MFS/TS对354到aN607A的测量距离将称为(-x1);MFS/TS对355的测量距离将称为(-x2);MFS/TS对356的测量距离将称为(-x3);MFS/TS对357的测量距离将称为(-x4)。
同样,按装在电磁体132X极面上的各个MFS/TS对350、351、352、353都将给XCA 305的处理器102X提供位置数据。从MFS/TS对350到aN607A的测量距离将称为(+x1);MFS/TS对351的测量距离将称为(+x2);MFS/TS对352的测量距离将称为(+x3);MFS/TS对353的测量距离将称为(+x4)。
由于MFS/TS对围绕着X轴线均匀地排列在一个象限内,MFS/TS中每个传感器单独测量到的距离可以经过数学综合用来确定aN607A到X轴本身的距离。该数学综合方法是确定位置矢量Ax1x2,Ax2x3,Ax3x4,Ax1x4。由图20可见,比如,位置矢量Ax2x3可由下式给出:
Ax 2 x 3 = x 2 x 3 Sin ( θ x 2 x 3 ) d
位置矢量Ax1x2,Ax3x4及Ax1x4的大小可按同样方式算出。
另外,如图20A所示,角度θx1x2,它是比如Ax1x2和x1以及Ax1x2和x2之间夹角之和。因此可以给出Ax1x2的方向如下:
θx 1 x 2 = cos - 1 ( d 2 - x 1 2 - x 2 2 2 x 1 x 2 )
图示于图20A中的数字解可用下面所述的正则形式得出。应当指出,这个数字解仅是作为例子在XCA 305的微处理器102x的背景模式下实施的;对于Y轴和Z轴也是相似的。
hx 1 x 2 = x 1 x 2 Sin ( θ x 1 x 2 ) d
Bx 1 x 2 = x 1 2 - hx 1 x 2 2
θx 2 x 3 = cos - 1 ( d 2 - x 2 2 - x 3 2 2 x 2 x 3 )
Ax 2 x 3 = x 2 x 3 Sin ( θ x 2 x 3 ) d
Bx 2 x 3 = x 2 2 - hx 2 x 3
P B x 1 = x 1 B x 2 2 + x B 2 x 3 2
Ax 1 x 2 = x 1 2 - P B x 1 2
以同样的方式计算角度θx2x3,θx3x4和θx1x4
根据从极面138x到点aN的距离Ax1x2,Ax2x3,Ax3x4,Ax1x4,可以确定平均距离(-xn)如下:
- x = ( ( - x 1 - x 2 A ) + ( - x 2 - x 3 A ) + ( - x 3 - x 4 A ) + ( - x 4 - x 1 A ) 4 )
同样,从极面132x到点aN的距离可确定如下:
+ x = ( x 1 x 2 A + x 2 x 3 A + x 3 x 4 A + x 4 x 1 A 4 ) .
按照一种实施例,进行校准时,采用更多的精确的传感器作加权平均,以得到更好的结果,从而得到加权平均值。
由于虚拟原点608是VT组件304和校准附件(CF)321之间的公共参考点,因此,可以确定aN和虚拟原点608之间的距离。由下面一组公式给出三个轴的这些距离,这里的XD616是两个同轴电磁体132x及138x(见图19)之间的距离,YD是两个同轴电磁体132y及138y之间的距离,ZD是两个同轴电磁体132z及138z之间的距离:
X D 2 + ( - X )
X D 2 + ( + X )
其中:
( X D 2 + ( - X ) ) + ( X D 2 + ( - X ) ) = X D
可对y轴及z轴的位置做同样的计算。已知这三个轴的位置后,即可得出绝对位置。所以,相对于虚拟原点有:
Xn = X D 2 - ( - Xn ) ( + Xn ) - X D 2       Xs = X D 2 - ( - Xs ) ( + Xs ) - X D 2
Yn = Y D 2 - ( - Yn ) ( + Yn ) - X D 2         Ys = Y D 2 - ( - Ys ) ( + Ys ) - X D 2
Zn = Z D 2 - ( - Zn ) ( + Zn ) - X D 2        Xs = Z D 2 - ( - Zs ) ( + Zs ) - X D 2
系统控制器302进行下列计算,以推得确定实际导管顶端的磁性元件的中心点:
Xc = Xn - Xs 2
Yc = Yn - Ys 2
Zc = Zn - Zs 2
于是,GCI装置501如下驱动实施X-Y平面中的旋转:
RotC = tan - 1 ( Yn - Ys Xn - Xs )
以及如下驱动实施X-Z平面中的旋转:
elevC = tan - 1 ( Zn - Zs Xn - Xs )
利用这些结果,系统控制器302可以将实际导管顶端377的位置和要求的顶端位置进行比较。图23所示为系统控制器(SC)302为了确定实际顶端377的位置利用下列数学关系所作的逻辑计算:
1.系统控制器(SC)302阻断X轴控制器和放大器(XCA)305、Y轴控制器和放大器(YCA)310和Z轴控制器和放大器(ZCA)315的调制器输出。
2.X轴控制器和放大器(XCA)305、Y轴控制器和放大器(YCA)310以及Z轴控制器和放大器(ZCA)315读取磁场传感器阵列307、308、312、313、317、318的输出。
3.X轴控制器和放大器(XCA)305、Y轴控制器和放大器(YCA)310以及Z轴控制器和放大器(ZCA)315读取温度传感器(TS)阵列306、309、311、314、316和319的输出。
4.X轴控制器和放大器(XCA)305、Y轴控制器和放大器(YCA)310以及Z轴控制器和放大器(ZCA)315通过修正数据(通常存储在非易失性存储器105x、105y和105z中),对磁场传感器阵列307、308、312、313、317、318的输出进行数字温度补偿。
5.系统控制器(SC)302接受来自X轴控制器和放大器(XCA)305、Y轴控制器和放大器(YCA)310以及Z轴控制器和放大器(ZCA)315的经过修正的磁场传感器数据输入,并插入来自实际顶端生成的磁场的三个正交分量(Bx、By、Bz)的5轴数据集。并按下两个式子计算实际顶端的位置,其中
a)力矢量B600的大小由下式给出:
B = Bx 2 + By 2 + Bz 2 ;
b)力矢量B的方向则由下面三个角度给出:
α = cos - 1 Bx B , β = cos - 1 By B , δ = cos - 1 Bx B
6.系统控制器(SC)302通过通信控制器(CC)320输入心脏位置数据,该心脏位置(CP)数据来自辅助设备(X射线设备、超声设备等)。由于心脏的搏动,该心脏位置(CP)数据是动态的数据。
7.系统控制器根据心脏位置(CP)以及HP数据集计算出实际位置(AP)。
8.系统控制器(SC)302输入来自虚拟顶端/校准附件控制器(VT/CFC)303的虚拟顶端405位置数据。
9.系统控制器(SC)302将心脏位置(CP)数据和虚拟顶端(VT)位置结合在一起并计算出所需位置DP。
10.系统控制器(SC)302比较DP和AP,并确定位置误差(PE)。
11.如果位置误差PE小于误差阈值,系统控制器(SC)302使得X轴控制器和放大器(XCA)305、Y轴控制器和放大器(YCA)310以及Z轴控制器和放大器(ZCA)315继续以相同的调制参数及极性工作。
12.如果位置误差PE超出误差阈值,系统控制器(SC)302改变工作循环和/或改变输入给相应XCA305、YCA310、ZCA315的调制参数及极性。
如果任何轴上的位置误差(PE)在一个预定的时间内超过预定值,系统控制器(SC)302便通过虚拟顶端/校准附件控制器(VT/CFC)303,以控制步进电机55、57、59、61和63,产生触觉反馈,以此提醒操作者导管顶端遇到了一个阻碍。这是因为如下的假设,如果在GCI装置501正常工作条件下经过预期一段时间或是经过包括上述步骤1至12的预期个数的循环的矫正仍不能消除该位置误差,那么,实际导管顶端可能是遇到了一个阻碍。这个能够被操作者感觉到的触觉反馈是由于步进电机55、57、59、61和63产生了作用在虚拟顶端405上的阻力造成的。
对于操作者或外科医生来说,虚拟顶端405的操作是相对较为简单且直观的。外科医生只要在要求方向上推、拉,或者转动虚拟顶端405,便可使实际导管顶端377在体内作相对应的运动。如果实际导管顶端377遇到了阻碍,虚拟顶端405就会在适宜的轴线方向上对运动产生阻力,对操作者发出触觉反馈。于是,外科医生在送进实际顶端时便能感觉到阻力。当操作者的手从虚拟顶端405上松开时,实际导管顶端377便可靠地保持在现时位置上。系统控制器(SC)302使实际顶端位置AT和CP数据相关联,所述的CP数据来自辅助设备322并通过CC 320传送给PC 324,以与复合的顶端图像及X射线/超声图像一起显示在监视器325上。根据HP数据实时地进行连续更新所述AT位置的三维显示图像。所述CP数据显示上叠加了帧数相对比较少X射线图像。之所以能够将AT数据和CP数据相关,是因为X射线图像和MFS阵列具有公共参考点(亦即二者相对于搏动中的心脏是稳态的)。本发明的设备及方法不但提供一种对心脏和导管顶端377的优越的观测方法,同时还显著地减小了X射线对患者和工作人员的辐照量。
因此,可以见到,本发明的导管导引控制设备及方法给出一种装置,这种装置比较容易有效使用;对使用者需要最少的训练;能够快速地将导管顶端送进到准确的位置;需要更少种类的导管;能够有力地将导管顶端固定在要求位置上;能够操纵导向线通过曲折的路径;能够使导向线或气囊有力地穿过硬斑部位;能够三维地显示导管顶端的位置;显著降低患者的影像对比度增强剂使用剂量;显著降低X射线对患者和医疗人员的辐照量;使用直观;而且,当导管顶端遇到阻碍时,能够对操作者发出触觉反馈。
尽管上面已经详细描述了本发明的几种实施例,但这些内容不构成本发明的范围,而是仅仅用以说明本发明的实施例。在本发明的范围内还可以作出许多其它的变型或修改。例如,对电磁体的调制可以控制为使其能够使顶端产生一种振动或脉冲运动,以帮助它通过硬斑部位;响应顶端可以是电磁体而不是永久磁体;可由一个或多个永久磁体生成作用在患者身上的磁场;可以通过对产生磁场的器件进行手工调整完成外磁场的控制;可以通过在顶端上缠绕一个或多个线圈的方式,使该顶端可以响应所施加的时变磁场,从而使得该装置能够利用交流感应磁体产生作用磁场;居里温度处于体温以下几度的材料可以用作为磁通量开关,通过以合适温度的流体对该开关进行激发的方式,实施对顶端的可选择性控制;静电现象可以用来增强磁效;人工智能可以用来替代操作者发出操作指令;专家系统也可以用来替代或帮助操作者进行操作;本装置也可以用来孕育(incubate)心脏以外的各种体腔及器官;本装置也可用在人类及动物的比如卵子获取及胚胎植入等程序中;也可以将响应顶端附着在一个密合的光学纤维束上,以观看内部构造并使该光学纤维束具有前所未有的灵活性;可以用导引导管将一个集装的放射源直接递送到肿瘤上,以准确地实施内部放射性同位素治疗;可以用本装置进行内部组织取样,而不必作大的外科手术;可将本发明的响应顶端附着在光纤/光导装置上,以将激光准确地照射到体内的特定位置,而不必进行大的外科手术;先前困难的脂肪吸除及其它的皮下外科医疗程序都可以用本发明装置来准确地实施,如此等等。于是,本发明的范围仅由所附的权利要求书来界定。

Claims (14)

1.一种用于控制具有待插入体内之远端的工具运动的方法,包括如下步骤:
通过生成外磁场对所述远端施加作用力;
调节所述作用力,使所述远端按所需方向运动;以及
通过测量所述远端的磁场确定所述远端的位置。
2.如权利要求1所述的方法,其中,还包括随着所述远端移过人体,实质上实时地更改所述远端的影像资料的步骤。
3.如权利要求1所述的方法,其中,还包括控制一个或多个电磁体以生成所述外磁场的步骤。
4.如权利要求1所述的方法,其中,还包括测量一个或多个磁场传感器的温度的步骤,所述磁场传感器测量所述远端的磁场。
5.如权利要求1所述的方法,其中,还包括确定所述远端的现有位置,并与所需位置比较的步骤。
6.如权利要求5所述的方法,其中,所述确定远端现有位置的步骤包括:
阻断系统控制器的调制器输出;
通过通信控制器输入心脏的动态位置;以及
计算所述远端的现有位置,该位置是所述心脏位置的函数。
7.如权利要求1所述的方法,其中,还包括计算所述远端位置误差的步骤。
8.如权利要求7所述的方法,其中,还包括步骤:当所述位置误差大于一定的最小值时,改变输入给所述X轴控制器、Y轴控制器、Z轴控制器中至少一个的调制工作周期及调制极性中的至少一项。
9.如权利要求7所述的方法,其中,还包括一旦沿至少一个轴的位置误差超过预定值便产生触觉反馈的步骤。
10.如权利要求1所述的方法,其中,所述系统控制器使所述工具的远端运动到与来自虚拟顶端的位置数据相应的位置。
11.一种控制具有待插入体内之远端的工具的运动的方法,包括如下步骤:
计算所述远端所需的运动方向;
计算产生所述运动所需的磁场;
控制多个电磁线圈中的电流,产生所述磁场;以及
测量所述远端的磁场,以定位所述远端。
12.如权利要求1所述的方法,其中,所述计算磁场的步骤包括:
确定所述远端关于一个或多个磁极的现有位置;以及
利用查表,找出产生所述运动所需的磁场。
13.如权利要求11所述的方法,其中,还包括控制一个或多个电磁体产生所述外磁场的步骤。
14.如权利要求11所述的方法,其中,还包括测量一个或多个磁场传感器的温度的步骤,所述传感器用于测量所述远端的磁场。
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DE60328990D1 (de) 2009-10-08
US7873401B2 (en) 2011-01-18
US20060114088A1 (en) 2006-06-01
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CA2493869A1 (en) 2004-01-22
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US20060116633A1 (en) 2006-06-01
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