CN102551876A - 接触力测量中的零漂移检测和校正 - Google Patents

接触力测量中的零漂移检测和校正 Download PDF

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CN102551876A
CN102551876A CN2011103661214A CN201110366121A CN102551876A CN 102551876 A CN102551876 A CN 102551876A CN 2011103661214 A CN2011103661214 A CN 2011103661214A CN 201110366121 A CN201110366121 A CN 201110366121A CN 102551876 A CN102551876 A CN 102551876A
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D.M.路德温
G.吉瓦蒂
A.特格曼
N.卡茨
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Abstract

本发明涉及接触力测量中的零漂移检测和校正。本发明公开了一种方法，包括：将具有力传感器的探针插入患者的体腔中；以及从所述力传感器接收多个测量值，每个测量值指示施加于所述力传感器上的力。所述方法还包括：检测在至少指定持续时间的时间期间内接收的测量值没有变化超过预定量；以及将所述力传感器的基线设定为基于在所述期间内接收的测量值的值，所述基线将在后续测量中使用。

Description

接触力测量中的零漂移检测和校正
技术领域
本发明整体涉及侵入式探针，具体地讲，涉及对侵入式探针内的力传感器进行校正。
背景技术
多种医疗手术涉及将物体，例如传感器、管子、导管、分配装置和植入物，放入患者体内。目前已为跟踪此类物体开发出了定位感测系统。磁性定位感测是本领域已知的方法之一。在磁性定位感测中，通常将磁场发生器置于患者体外的已知位置处。探针远端内的磁场传感器在这些磁场作用下产生并处理电信号，以确定探针远端的定位坐标。这些方法和系统在美国专利5,391,199、6,690,963、6,484,118、6,239,724、6,618,612和6,332,089中、在PCT国际专利公布WO 1996/005768中、以及在美国专利申请公布2002/0065455 A1、2003/0120150 A1和2004/0068178 A1中有所描述，这些专利的公开内容全部以引用方式并入本文。
当将探针置于体内时，期望探针远侧顶端直接接触身体组织。通过(例如)测量远侧顶端和身体组织之间的接触压力，可以确认接触情况。其公开内容以引用方式并入本文中的美国专利申请公布2007/0100332、2009/0093806和2009/0138007描述了使用埋入导管内的力传感器感测导管远端顶端与体腔内的组织之间的接触压力的方法。
发明内容
本发明的一个实施例提供一种方法，该方法包括：
将具有力传感器的探针插入患者的体腔中；
从所述力传感器接收多个测量值，每个测量值指示施加于所述力传感器上的力；
检测在至少指定持续时间的时间期间内接收的测量值没有变化超过预定量；以及
将所述力传感器的基线设定为基于在所述期间内接收的测量值的值，所述基线将在后续测量中使用。
通常，所述探针包括心导管。
在一个实施例中，所述体腔包括心室。
所述方法可包括：
当检测到所述测量值没有变化超过所述预定量时向所述测量值应用滤波器，所述滤波器被构造为隔离处于特定频率范围内的滤波的测量值；以及
当检测到滤波的测量值没有指示所述探针与所述体腔组织之间的接触时设定所述基线。
通常，设定所述基线包括计算基于接收的测量值的函数。所述函数可为接收的测量值的平均值。
在本发明所公开的实施例中，所述指定持续时间包括至少单个心动期间。
在可供选择的实施例中，所述预定量大于所述力传感器的噪声变化。
在另一可供选择的实施例中，所述方法包括当检测到接收的测量值变化超过所述预定量时，通过用接收的测量值减去所述基线来评估由所述探针的远侧顶端施加于所述体腔表面的力。
根据本发明的另一实施例，还提供了一种设备，包括：
探针，其被构造用于插入患者的体腔，并包括力传感器以用于测量施加于所述力传感器上的力；以及
处理器，其被构造为从所述力传感器接收多个测量值，每个测量值指示所述力，以检测在至少指定持续时间的时间期间内接收的测量值没有变化超过预定量，并将所述力传感器的基线设定为基于在所述期间内接收的测量值的值，所述基线将在后续测量中使用。
根据本发明的另一实施例，还提供了一种结合医疗探针运行的计算机软件产品，所述医疗探针包括力传感器以用于测量施加于所述力传感器上的力，所述产品包括存储有程序指令的非暂时计算机可读介质，所述指令在被计算机读取时使得所述计算机从所述力传感器接收多个测量值，每个测量值指示所述力，以检测在至少指定持续时间的时间期间内接收的测量值没有变化超过预定量，并将所述力传感器的基线设定为基于在所述期间内接收的测量值的值，所述基线将在后续测量中使用。
附图说明
本文参照附图，仅以举例说明的方式描述本发明，在附图中：
图1为根据本发明的实施例的用于压敏导管的零漂移检测和校正系统的示意性图示说明；
图2为示出根据本发明的实施例的压敏导管的远侧部分细节的示意性侧视图；
图3是示出根据本发明的实施例的压敏导管的零漂移的曲线图；以及
图4是示意性地示出根据本发明的实施例的压敏导管的零漂移检测和校正方法的流程图。
具体实施方式
概述
诸如心脏消融和心内电标测之类的各种诊断和治疗手术使用了诸如导管的侵入式探针，其远侧顶端配有至少一个电极。电极通常在探针被压贴到体腔表面上时工作。在这些手术中，通常重要的是确定远侧顶端施加于体腔表面的力。因此，一些导管包括力传感器以用于测量探针和体内组织(例如，心内膜)之间的力。
为了精确测量远侧顶端施加于心内膜上的力，力传感器通常被校准至“零水平”(本文中也称作基线)。在本发明的实施例中，从远侧顶端与任何表面具有最小接触(因此，基本上没有有效的力施加于远侧顶端上)时力传感器所产生的测量值来确定基线。一旦识别出基线，来自力传感器的测量值就可用于得到施加的力的值。
由于导管中的力传感器通常依赖于模拟元件，所以传感器易受“基线漂移”影响，其中基线可能由于包括(但不限于)(即，模拟元件的)温度和老化在内的因素而改变。基线漂移可导致力传感器的零水平不准确，从而给远侧顶端与体内组织接合时评估的力带来误差。为确保精确的力值，本发明的实施例提供用于检测和校正设置在导管中的力传感器的基线漂移的方法和系统。在一些实施例中，在心内手术过程中(即，在导管处于患者心脏内部的同时)监测来自力传感器的测量值。在所述手术过程中，当检测到测量值处于预定噪声阈值内(即，测量值相对较稳定)达指定持续时间时，则认为导管与心内膜组织脱离接触，并利用在所述指定持续时间内收集的测量值计算当前基线。
另一方面，当测量值超过所述预定噪声阈值变化时，可认为导管与心内膜组织接触。在这些情况下(即，在测量值变化时)接收的测量值可用于给出施加于传感器上的力的值。
本发明的实施例允许动态系统中的力传感器的自动校准。在一些实施例中，力传感器可在每当检测到基线改变时自动重新校准，即使在心内手术过程中检测到所述改变时亦是如此。检测和校正力传感器中的基线漂移使导管插入术系统能够以改善的精确度和可靠性测量力。
系统说明
图1是根据本发明的实施例的使用零漂移检测和校正的医疗系统20的示图。系统20可以是基于例如由Biosense Webster Inc.(Diamond Bar，California)制造的CARTOTM系统。系统20包括探针22(诸如导管)和控制台24。在下述的实施例中，假设探针22用于诊断或治疗处理，例如对心脏26中的电势进行标测或进行心脏组织的消融。作为另外一种选择，加以必要的变更，探针22可用于心脏中或其他身体器官中的其他治疗和/或诊断用途。
操作者28(例如心脏病学家)将探针22穿过患者30的血管系统插入，以使得探针22的远端32进入心脏26的心室。操作者28推入探针22，以使得探针22的远侧顶端34在所需一个或多个位置处接合心内膜组织。探针22通常由在其近端处的合适的连接器连接到控制台24。
控制台24通常利用磁性定位感测确定心脏26内的远端32定位坐标。为了确定定位坐标，控制台24中的驱动电路36驱动磁场发生器38，以在患者30体内产生磁场。通常，磁场发生器38包括线圈，线圈在患者30体外的已知位置处被置于患者躯干下方。这些线圈在包含心脏26在内的预定工作空间内产生磁场。探针22的远端32内的磁场传感器62(在图2中更详细地示出传感器62)响应于这些磁场产生电信号。信号处理器40处理这些信号以确定远端32的定位坐标，通常包括位置和取向坐标。上述定位感测方法在上述CARTOTM系统中实施，并且在上文引用的专利和专利申请中有详细描述。
信号处理器40通常包括通用计算机，其具有合适的前端和接口电路，用于从探针22接收信号并控制控制台24的其他元件。处理器40可以在软件内编程，以执行本文所述功能。例如，可以经网络将软件以电子形式下载到控制台24中，或可以将软件保存在非暂时性有形介质(诸如光学、磁或电子存储介质)上。作为另外一种选择，可通过专用或可编程数字硬件元件执行处理器40的一些或全部功能。
输入/输出(I/O)接口42允许控制台24与探针22交互。基于从探针22(经由接口42和系统20的其他元件)接收的信号，处理器40驱动显示器44，以向操作者30呈现示出远端32在患者体内的定位的图像46，以及关于正在进行的手术的状态信息和指导。
在本实施例中，处理器40监测在确信导管与心内膜脱离接触的时间期间内从远端32内的力传感器64(图2中更详细地示出力传感器64)接收的信号测量值，并检测任何基线漂移。如果检测到基线漂移，处理器40可校正在远侧顶端34与心内膜组织接合时来自力传感器的信号，以便对传感器所经受的力进行精确评估。
处理器40将表示数据的图像46存储在存储器48中。在一些实施例中，操作者28可利用一个或多个输入装置50调控图像46。
作为另外一种选择或除此之外，系统20可以包括用于在患者30体内操纵和操作探针22的自动化机构(未示出)。该机构通常能够控制探针22的纵向运动(前进/后退)和探针的远端32的横向运动(偏转/转向)。在此类实施例中，处理器40基于探针内的磁场传感器所提供的信号产生用于控制探针22的运动的控制输入。
尽管图1示出了具体的系统构造，但也可以采用其他系统构造来实现本发明的实施例，并因而被认为是在本发明的精神和范围内。例如，实施下文描述的方法时，可使用除了上述磁场传感器之外其他类型的定位转换器，例如基于阻抗的定位传感器或超声定位传感器。如本文所用，术语“定位传感器”指安装在探针22上的元件，该元件引发控制台24能接收指示元件坐标的信号。因而该定位传感器可包括探针上的接收器，其基于传感器接收到的能量产生定位信号至控制器；或传感器可以包括发射器，发射出探针外部的接收器可感测的能量。此外，类似地，实施下文描述的方法时，不仅可以使用导管，而且可以使用其他类型的探针在心脏和其他身体器官及区域中进行治疗和诊断应用。
图2为根据本发明的实施例的探针22的远端32的示意性剖视图。具体地讲，图2示出用于治疗和/或诊断活动的远端32的功能元件。探针的远侧顶端34处的电极60(例如，消融电极)通常由金属材料(例如，铂/铱合金)或其他合适的材料制成。作为另外一种选择，沿探针长度的多个电极(未示出)可用于此目的。
定位传感器62向控制台24发送指示远端32的位置坐标的信号。定位传感器62可包括一个或多个微型线圈，并且通常包括多个沿不同轴取向的线圈。作为另外一种选择，定位传感器62可包括另一类型的磁性传感器、充当定位转换器的电极或其他类型的定位转换器，例如基于阻抗的定位传感器或超声定位传感器。虽然图2示出了具有单个定位传感器的探针，但本发明的实施例可以采用具有不止一个定位传感器的探针。
在可供选择的实施例中，定位传感器62和磁场发生器38的作用可以互换。换句话讲，驱动电路36可驱动远端32内的磁场发生器，以产生一个或多个磁场。发生器38内的线圈可被构造以感测磁场并产生指示这些磁场的分量的幅度的信号。处理器40接收并处理这些信号，以确定远端32在心脏26内的定位坐标。
力传感器64通过向控制台传输指示远侧顶端施加于体内组织上的力的信号来测量由远侧顶端34施加到心脏26的心内膜组织的力。在一个实施例中，力传感器可包括通过远端32中的弹簧连接的磁场发射器和接收器，并可基于弹簧偏转的测量来产生力的指示。这类探针和力传感器的更多细节在美国专利申请公布2009/0093806和2009/0138007中有所描述，这些专利的公开内容以引用方式并入本文中。作为另外一种选择，远端32可包括另一类力传感器。
零漂移检测和校正
图3是示出根据本发明实施例的在心内手术过程中对于包括由力传感器64发送来的测量值的信号72，力(克)对时间(秒)的曲线图70。当信号72在指定持续时间Tmax内处于噪声阈值ΔFmin内时，可认为远侧顶端34与心内膜组织脱离接触。另一方面，当信号72变化超过ΔFmin时，可认为远侧顶端34与心内膜组织接触。
噪声阈值ΔFmin通常被设定为比力传感器64的噪声变化大的值。例如，如果力传感器64具有1.0克的噪声变化，则ΔFmin可被设定为3.0克。在一个实施例中，以举例的方式，ΔFmin的值被设定为等于±3σ，其中σ是当其与组织脱离接触时来自传感器64的信号的标准偏差。本领域普通技术人员将能够定义其他噪声阈值的值，例如±nσ(其中n为实数)，或者基于峰峰变化的阈值，而无需过度实验，所有此类阈值均被认为包括在本发明的范围内。
在一个实施例中，Tmax可被设定为2.5秒，这显著长于心脏26的单个心动期间(心动期间通常小于或等于1.0秒)。
在时间期间78内，信号72变化到ΔFmin所限定的范围之外(由于心脏26的跳动)，这指示远侧顶端34可能与心内膜组织接触。然而，在时间期间79(在曲线图70所示的例子中等于Tmax)内，信号72在ΔFmin内变化，这指示远侧顶端34可能与心内膜组织脱离接触。在期间Tmax内信号的变化量小于或等于ΔFmin指示在此期间内没有有效的力施加于传感器64上。在此期间内获得的信号因而可用于制定传感器的基线，如通过图4的流程图更详细说明的。
在一些实施例中，即使在信号72的变化等于或小于ΔFmin时也有可能存在组织接触。为了在信号72的变化等于或小于ΔFmin时验证组织接触，处理器40可应用滤波器以隔离信号72的特定频率。滤波器(通常为带通滤波器)被构造为使频率接近心率频率(即，在这种情况下，心脏26的频率)的信号通过，而阻挡其他频率。当远侧顶端34与移动对象(例如，心内膜组织)的接触程度较低时，通过允许对滤波信号的水平与带通频率的预定水平进行比较，带通滤波器可提供信号72的更精确的分析。
图4是示意性地示出根据本发明实施例的利用零漂移检测和校正的心脏消融方法的流程图。应当理解，该流程图仅为举例，本发明的实施例不限于涉及心脏消融的手术。相反，只要需要在力传感器在体内操作时确定力传感器的基线，就可使用本发明的实施例。
在初始步骤80，操作者30利用输入装置50设定噪声阈值ΔFmin、指定持续时间Tmax和带通频率的预定水平，如上所述。作为另外一种选择，ΔFmin、Tmax和所述预定水平可在消融手术之前限定，并存储在存储器48中。
在操作者30在定位步骤82中定位探针22之后，处理器40在收集步骤84中收集指定持续时间Tmax内来自力传感器64的测量值。在第一比较步骤86中，如果收集的力测量值在ΔFmin内，则在滤波步骤87中，处理器40应用带通滤波器，以通过隔离特定频率范围内的测量值来对力传感器测量值滤波，如上所述。在第二比较步骤88中，如果滤波的力测量值没有指示探针-组织接触，则该方法继续至基线计算步骤89。步骤88中所执行的比较(为了评估是否指示接触)通常包括滤波的力测量值的水平与步骤80中所限定的带通频率的预定水平的比较。在基线计算步骤89中，处理器40通过对收集的力测量值(即，在指定持续时间内收集的那些测量值)取平均来计算新的基线。作为另外一种选择，处理器40可基于收集的力测量值计算可供选择的函数以确定新的基线。
在第三比较步骤90中，如果新的基线不同于当前与力传感器64关联的基线(即，先前的基线)，则处理器40在重新校准步骤92中，通过将力传感器的零水平设定至新的基线来重新校准力传感器64，并且处理器可在显示器44上显示通知，以告知操作者28自动基线改变。作为另外一种选择，处理器可在显示器44上显示消息，以通知操作者28基线改变。在这种情况下，可向操作者提供保留先前的基线或执行新的基线的选择权。在稍后与心内膜组织接触过程中可执行新的基线。
在重新校准力传感器64之后，处理器40在提示步骤94中在显示器44上显示操作者28可重新定位探针22的通知，该方法返回步骤82。返回步骤90，如果基线没有改变，则该方法继续步骤94。
返回步骤86和88，如果收集的力测量值超过ΔFmin(即，在步骤86中收集的测量值变化超过预定量ΔFmin)或者滤波的力测量值指示探针-组织接触(在步骤88中)，则认为远侧顶端34经受非零的力，通常这是因为其与心内膜组织(或体腔的其他表面)接触，该方法前进到力计算步骤96。在步骤96中，处理器40用(即，在远侧顶端34和心内膜组织之间接触过程中)收集自力传感器64的测量值减去当前基线，从而得到远侧顶端34施加在心内膜组织上的力的精确测量。在一些实施例中，当认为远侧顶端34经受非零的力时(即，在时间期间78内)，处理器40可在显示器44上显示警告操作者28不要进行新基线的计算的通知。
在第四比较步骤98中，如果计算的力在消融可接受的预定范围内，则在消融步骤100中，处理器40在显示器上44上显示提示操作者28以当前探针定位进行消融的通知。返回步骤98，如果计算的力不在所述预定范围内，则该方法继续步骤94。最后，在第五比较步骤102中，如果心脏26中还有另外的区域待消融，则该方法继续步骤94，直到消融手术完成为止。
以下权利要求书中的相应结构、材料、操作和所有方法或步骤以及功能元件的等同形式旨在包括任何结构、材料或者操作，以用于执行与在权利要求中具体保护的其他受权利要求保护的元件相结合的功能。已提供了对本发明的描述以用于举例说明和描述的目的，但并非旨在详尽描述本发明或将本发明限制为本发明所公开的形式。在不脱离本发明的范围和精神的前提下，许多修改形式和变型形式对于本领域的普通技术人员而言将显而易见。选择并描述了以上实施例，以便最好地解释本公开的原理和实际应用，以及使本领域的其他技术人员能够理解本公开的各种实施例具有适于所考虑的具体用途的各种修改形式。
应当理解上述实施例仅是举例方式的援引，本发明并不限于上文具体示出和描述的内容。更确切地说，本发明的范围包括上述各种特征的组合和子组合、以及本领域技术人员在阅读上述说明书时可能想到的并且现有技术中未公开的变型形式和修改形式。

Claims (20)

1.一种方法，包括：
将具有力传感器的探针插入患者的体腔中；
从所述力传感器接收多个测量值，每个测量值指示施加于所述力传感器上的力；
检测在至少指定持续时间的时间期间内接收的测量值没有变化超过预定量；以及
将所述力传感器的基线设定为基于在所述期间内接收的测量值的值，所述基线将在后续测量中使用。
2.根据权利要求1所述的方法，其中所述探针包括心导管。
3.根据权利要求1所述的方法，其中所述体腔包括心室。
4.根据权利要求1所述的方法，包括：
当检测到所述测量值没有变化超过所述预定量时向所述测量值应用滤波器，所述滤波器被构造为隔离处于特定频率范围内的滤波的测量值；以及
当检测到滤波的测量值没有指示所述探针与所述体腔组织之间的接触时设定所述基线。
5.根据权利要求1所述的方法，其中设定所述基线包括计算基于接收的测量值的函数。
6.根据权利要求5所述的方法，其中所述函数包括接收的测量值的平均值。
7.根据权利要求1所述的方法，其中所述指定持续时间包括至少单个心动期间。
8.根据权利要求1所述的方法，其中所述预定量大于所述力传感器的噪声变化。
9.根据权利要求1所述的方法，包括当检测到接收的测量值变化超过所述预定量时，通过用接收的测量值减去所述基线来评估由所述探针的远侧顶端施加于所述体腔表面的力。
10.一种设备，包括：
探针，其被构造用于插入患者的体腔，并包括力传感器以用于测量施加于所述力传感器上的力；以及
处理器，其被构造为从所述力传感器接收多个测量值，每个测量值指示所述力，以检测在至少指定持续时间的时间期间内接收的测量值没有变化超过预定量，并将所述力传感器的基线设定为基于在所述期间内接收的测量值的值，所述基线将在后续测量中使用。
11.根据权利要求10所述的设备，其中所述探针包括心导管。
12.根据权利要求10所述的设备，其中所述体腔包括心室。
13.根据权利要求10所述的设备，其中所述处理器被构造为当检测到所述测量值没有变化超过所述预定量时向所述测量值应用滤波器，所述滤波器被构造为隔离处于特定频率范围内的滤波的测量，当检测到滤波的测量值没有指示所述探针与所述体腔组织之间的接触时设定所述基线。
14.根据权利要求13所述的设备，其中所述滤波器包括带通滤波器。
15.根据权利要求10所述的设备，其中所述处理器被构造为通过计算基于接收的测量值的函数来设定所述基线。
16.根据权利要求15所述的设备，其中所述函数包括接收的测量值的平均值。
17.根据权利要求10所述的设备，其中所述指定持续时间包括至少单个心动期间。
18.根据权利要求10所述的设备，其中所述预定量大于所述力传感器的噪声变化。
19.根据权利要求10所述的设备，其中所述处理器被构造为当检测到接收的测量值变化超过所述预定量时，通过用接收的测量值减去所述基线来评估由所述探针的远侧顶端施加于所述体腔表面的力。
20.一种结合医疗探针运行的计算机软件产品，所述医疗探针包括力传感器以用于测量施加于所述力传感器上的力，所述产品包括存储有程序指令的非暂时计算机可读介质，所述指令在被计算机读取时使得所述计算机从所述力传感器接收多个测量值，每个测量值指示所述力，以检测在至少指定持续时间的时间期间内接收的测量值没有变化超过预定量，并将所述力传感器的基线设定为基于在所述期间内接收的测量值的值，所述基线将在后续测量中使用。
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JP2012096036A (ja) 2012-05-24
EP2449996A2 (en) 2012-05-09
CN102551876B (zh) 2015-10-14
JP6042062B2 (ja) 2016-12-14
EP2449996B1 (en) 2017-08-02
AU2011239365A1 (en) 2012-05-17
AU2011239365B2 (en) 2015-07-16
IL215744A (en) 2015-09-24
US8979772B2 (en) 2015-03-17
EP2449996A3 (en) 2013-03-13

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