CN102805611B - 隆起的检测 - Google Patents
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Abstract
本公开涉及隆起的检测。本发明提供了一种方法，所述方法包括测量由探针施加在患者的组织上的力，以及在测量所述力的同时测量所述探针的位移。所述方法还包括响应于所述所测得的力和所述所测得的位移之间的关系而检测所述组织的隆起。
Description
技术领域
本发明总体涉及医学手术，具体地涉及手术中对隆起的检测。
背景技术
使用导管探针进行的侵入性医学手术通常涉及探针接触到进行该手术的患者的内部组织。这样的接触通常涉及探针向组织施加力，并且这种力又可能导致组织出现不期望的隆起。
Zhang的美国专利申请2006/0173480描述了一种系统，该系统据称能更准确地控制穿透性器械(例如，套管针、针等)向体腔、器官或潜在空间中的插入，所述申请的公开内容以引用方式并入本文中。该公开内容描述了将加速计连接到穿透性器械，以便实现控制。
以引用方式并入本专利申请的文献将视为本专利申请的整体部分，但不包括在这些并入的文献中以与本说明书中明确或隐含地给出的定义相冲突的方式定义的任何术语，而只应考虑本说明书中的定义。
以上描述给出了本领域中相关技术的总体概述，不应当被解释为承认了其包含的任何信息构成对抗本专利申请的现有技术。
发明内容
本发明的一个实施例提供一种方法，该方法包括：
测量由探针施加在患者的组织上的力；
在测量力的同时测量探针的位移；以及
响应于所测得的力与所测得的位移之间的关系检测组织的隆起。
通常，检测隆起包括确认该关系由所测得的力的变化的第一大小与所测得的位移的第二大小之间的数学上正相关的关系组成。该方法还可包括测量所测得的力在由所测得的位移限定的方向上的变化。
在本发明所公开的实施例中，测量力包括测量力的变化，检测隆起包括确定力的变化大于预设的力变化范围。
在本发明所公开的另一个实施例中，检测隆起包括确定位移大于预设的位移范围。
该方法可包括响应于所测得的位移测量隆起的尺寸。
通常，该方法包括响应于检测到隆起而向探针的操作者发出警告。
在另选的实施例中，该方法包括响应于检测到隆起而调节组织的坐标图。通常，组织的隆起包括组织中的锥形形成物，并且调节该图包括将该图制作成缺少锥形形成物的顶点的位置。通常，制作该图包括确定锥形形成物的底部的位置，并且在制作该图的过程中使用底部的位置的坐标。
在另一个另选的实施例中，该方法包括响应于患者的心跳和呼吸中的至少一项校正所测得的力。
根据本发明的一个实施例，还提供了一种装置，其包括：
探针，该探针包括：
力传感器，该力传感器被构造成测量由探针施加在患者的组织上的力，和
位置传感器，该位置传感器被构造成在力传感器测量力的同时测量探针的位移；和
处理器，该处理器被构造成响应于所测得的力与所测得的位移之间的关系检测组织的隆起。
根据本发明的一个实施例，还提供了计算机软件产品，该软件产品包括内部记录着非易失性计算机程序指令的有形的计算机可读介质，这些指令在被计算机读取时，会促使计算机：
测量由探针施加在患者的组织上的力；
在测量力的同时测量探针的位移；以及
响应于所测得的力与所测得的位移之间的关系检测组织的隆起。
通过以下对本发明实施例的详细说明并结合附图，将更全面地理解本发明。
附图说明
图1是根据本发明一个实施例的隆起检测系统的示意图；
图2是根据本发明一个实施例的在该系统中使用的探针的远端的示意图；
图3示出根据本发明一个实施例的在操纵探针过程中可能产生的隆起情况；
图4示出根据本发明一个实施例的在操纵探针过程中可能产生的另一种隆起情况；以及
图5是根据本发明一个实施例的用于检测隆起的方法的流程图。
具体实施方式
概述
本发明的一个实施例提供了一种用于检测患者的身体组织中的隆起的方法。该方法通常可在患者进行医学手术的同时应用，所述医学手术包括将探针插入患者心脏的腔。该方法包括测量由探针施加在身体组织上的力。在心脏手术的情况中，组织通常为心内膜。在测量力的同时，也测量组织的位移。两种测量可以使用探针中的分别的传感器进行，一个传感器测量探针的位置，另一个传感器测量由探针施加在组织上的力。
通过将所测得的力的行为与所测得的位移的行为进行比较观察，即通过观察两种参数的相互关系，可以检测隆起。通常，如果在位移方向上所测得的力随着位移增加而增加，即如果在力的大小和位移的大小之间存在数学上正相关的关系，则隆起正在发生。
隆起期间发生的正相关关系与不发生隆起时的典型关系形成对比。在探针接触到心内膜的情况中，心脏的跳动和/或患者的呼吸通常引起探针的位移和探针所测得的力两者发生变化。然而，在“正常”的无隆起情况下，力通常随着位移的增加而减小，从而这两个量具有数学上负相关的关系。
因此，力和隆起期间发生的位移之间的正相关关系提供了对隆起检测的简单明了的指示。
系统描述
现在参考图1和图2，图1是根据本发明实施例的隆起检测系统20的示意图，图2是根据本发明实施例的在该系统中使用的探针的远端的示意图。系统20包括探针22(在本文中假定为导管)和控制台24。在本文所述实施例中，以举例方式假设探针22可用于测绘患者28的心脏26的电势。作为另外一种选择或除此之外，探针22可用于心脏中或另一身体器官中的其他治疗和/或诊断目的，例如用于消融。
控制台24包括处理器42，通常为通用计算机，其具有合适的前端电路和接口电路，用于接收来自探针22的信号，并且用于控制本文所述系统20的其他部件。处理器42可以在软件中编程以执行该系统所用的功能，并且该处理器在存储器50中存储用于该软件的数据。例如，可以经网络将软件以电子形式下载到控制台24中，或可以在非暂时性有形介质(诸如光学、磁或电子存储介质)上提供该软件。作为另外一种选择，可通过专用或可编程的数字硬件元件执行处理器42的一些或全部功能。
操作者30将探针22穿过患者28的血管系统插入，以使得探针22的远端32进入心脏26的腔。系统20通常利用磁性位置感测来确定在心脏26内的该远端的位置坐标。在这种情况下，控制台24包括驱动电路34，该驱动电路驱动设置在患者28体外的已知位置(如位于患者躯干下方)处的磁场发生器36。在探针远端内的磁场传感器38响应于来自线圈的磁场而产生位置电信号，从而使处理器42能够确定在该腔内的远端32的位置，即定位，通常也为取向。传感器38，本文也称为传感器“P”，通常包括一个或多个线圈，通常为彼此正交的三个线圈。这个位置感测方法例如在由Biosense Webster Inc.(Diamond Bar，California)制造的CARTOTM系统中实施并在美国专利5,391,199、6,690,963、6,484,118、6,239,724、6,618,612和6,332,089中，在PCT专利公布WO 96/05768中以及在美国专利申请公布2002/0065455A1、2003/0120150A1和2004/0068178A1中有详细描述，它们的公开内容全部以引用方式并入本文。
在另选的实施例中，定位传感器38和磁场发生器36的作用可以互换。换句话讲，驱动电路34可以驱动远端32中的磁场发生器以产生一个或多个磁场。发生器36中的线圈可被构造用来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42接收并处理这些信号，以确定心脏26内的远端32的位置。
虽然在本实例中假定系统20使用基于磁的传感器来测量远端32的位置，但本发明的实施例可以使用其他位置跟踪技术，例如，基于阻抗测量的位置跟踪技术。基于阻抗的位置跟踪技术在(例如)美国专利5,983,126、6,456,864和5,944,022中有描述，其公开内容也以引用方式并入本文中。本领域的普通技术人员已知的其他位置跟踪技术也可用来确定远端32的位置。因此，在本申请中，术语“位置传感器”用来表示根据探针或一段探针(例如探针的远端)的位置和取向给控制台24提供信号的任何元件。
远端32还包括力传感器48，本文中也称为传感器“F”，其能够给处理器42提供力的电信号，以便测量在远端上的力的大小和方向。力的方向通常是相对于远端的对称轴52测量。有各种技术可用于测量力。可用于这个目的的部件和方法在例如美国专利申请公布2009/0093806和2009/0138007中有描述，专利申请的公开内容以引用方式并入本文中，并且所述专利申请转让给本专利申请的受让人。这些专利申请描述了这样的探针，其远端尖头通过弹簧承载的接头连接到探针的远端，当探针的远端尖头接合组织时，弹簧承载的接头会响应于施加在远端尖头上的压力而变形。位于探针内的磁性位置感测组件，包括位于接头相对侧的发射和接收线圈在内，会感测远端尖头相对于探针远端的位置。这个相对位置的变化指示弹簧的变形，从而提供有关探针(即其远端尖头)上的力的大小和方向的指示。
为了测绘心脏26的腔，操作者30操纵探针22，以使得远端32处于该腔的内表面上(或接近内表面)的多个位置处。在每一个位置处，连接到该远端的电极40测量某种生理特性(例如，局部表面电势)。处理器42将来自传感器38的位置信号的位置测量值与电势测量值相关联。因此，该系统收集多个测绘点，每一个测绘点包括腔内表面上的坐标以及此坐标处的相应的生理特性测量值。
处理器42使用各测绘点的坐标来构建所关注的腔的模拟表面。构建模拟表面的示例性方法在下文进一步描述。然后，处理器42将各测绘点的电势测量值与模拟表面结合，以产生遍布模拟表面的电势的图。处理器42在显示器46上向操作者30显示该图的图像44。
图3和图4分别示出了根据本发明的实施例的在操作者30操纵探针22过程中可能产生的第一和第二隆起情况。隆起是组织(本文假定为心壁102)中局部大致锥形结构或“帐篷状物”的形成，并且通常由组织的区域104上的过度的力所引起，导致该区域形成隆起的圆锥。过度的力通常由按压区域104的探针的远端尖头引起，该尖头与该区域的接触位置形成帐篷状物的顶点。在重构该区域的过程中，隆起效应也可以被说成该重构中的圆锥形形成物或帐篷状物。
处理器42可使用表面重构算法来产生壁的表面图，该算法通常连接心壁的一组测绘位置的各最远点。举例说，点106和108假定为包括在该组测绘点内。在这种情况下，诸如区域104的隆起区域可以引起图中的显著变形，如上所述。更严重地，过度的隆起可能导致隆起部位处的心壁穿孔。如本文所述，本发明的实施例向操作者30提供隆起正在发生的警告，并且也校正该表面图中由隆起引起的任何变形。
发明人已经观察到，当随着探针在力的方向上向前移动从而探针和被探针接触的组织之间的力增加时，通常发生隆起。这种情况通常发生在探针的远端正面接合组织时。当探针周围的导向护套约束探针以便在非正面方向或倾斜方向上接合组织时，发生另一种情况。在这种情况下，虽然探针相对于组织的取向是倾斜的，但探针的运动是在与组织上的分解力(resolved force)相同的方向上。在两种情况下，力的大小和位移的大小都彼此呈数学上正相关的关系，即随着力的大小增加时，位移的大小也增加。
后一种性质与接触“正常”心壁的探针的典型情况形成对照，在该情况中，随着心壁由于心跳和/或由于呼吸而移动离开探针，探针所测得的力的大小减小，而位移的大小增加。这种数学上的负相关关系，即力随着位移的增加而减小，不论探针与心壁之间的接触为正面的或倾斜的都会发生。
图110(图3)示出了第一隆起情况，其中远端32接触心壁102并在其上施加力。在这种情况下，探针22以正面方式接合心壁102。箭头112表示由探针在区域104上施加的力向量，由力传感器F测得。箭头114表示探针在区域104中从开始发生隆起的位置116到隆起结束的位置118的位移向量。举例说，假定位移的方向定义区域104的局部x轴的方向。位置118对应于在区域104中形成的隆起圆锥的顶点，并且位移向量可从由位置传感器P所测得的位置得到。如图所示，力向量和位移向量是平行的。
示意性的坐标图120绘出了随着隆起情况的发展，即随着探针的远端尖头从位置116移动至位置118，力的大小|F|与位移的大小|D|的关系。如向右上方倾斜的坐标图所示出的，在隆起的情况中，这两个大小是正相关的。
为了比较，示意性的坐标图125绘出了当不存在隆起时，即在心壁由于心跳和/或呼吸而运动过程中，力的大小|F|与位移的大小|D|的关系。在这个无隆起情况中，随着位移的大小的增加，力的大小减小，因此这两个大小是负相关的。这由向右下方倾斜的坐标图示出。
图130(图4)示出了第二隆起情况，其中远端32接触心壁102并在其上施加力。在这个第二情况中，探针22受护套132约束，从而倾斜地接合心壁102。与箭头114大致相同的箭头134表示探针从初始隆起位置116的位移向量。箭头136表示由探针施加在区域104上的总的力向量，而箭头138表示在位移方向上(即平行于x轴)分解的力向量。在第二隆起情况中，总力的方向不平行于位移，并且在一个实施例中，在位移方向上分解的力的大小通常为总力的大小的值的大约80％，视倾斜程度而定。80％对应于大约30°的倾角，但本发明的实施例涵盖了其他角度，可以大于或小于30°，例如45°。
示意性的坐标图140绘出了随着第二隆起情况发展，分解的力的大小|Fx|与位移的大小|D|的关系。如坐标图所示，在第二隆起情况中这两个大小也是正相关的。
下面结合图5的流程图描述坐标图120和140所示的F范围、D范围、|ΔD|、|ΔF|和|ΔFx|等数量。
图5是根据本发明一个实施例的用于检测隆起的方法的流程图150。该方法使用上文结合图3和4所述的关于力和位移之间的关系的特性，并且以举例的方式涉及在心内膜中检测隆起。
在第一步骤152中，操作者30将探针22插入患者28体内，以使得探针的远端32进入心脏26的腔。探针被插入到接触心内膜为止。与心内膜的接触可通过多种不同方法检测，例如通过观察电极40上的电势对应于心内膜产生的电势，确定由力传感器48所测得的力大于传感器的零水平，和/或确定由位置传感器38所记录的位置对应于心内膜的坐标来检测。心内膜坐标可从位置传感器38的此前测量值确定，和/或通过使用超声波、荧光检查或磁共振成像的系统对心脏26进行成像来确定。
在步骤152中，可将不带周围护套的探针插入以接触心内膜，如图3示意性地示出的。作为另外一种选择，探针可具有周围护套，如图4所示。
在力测量步骤154中，处理器42使用来自力传感器48的信号计算由探针22的远端施加在心内膜的组织上的力的大小。处理器也评价来自信号的相对于远端的对称轴52(图2)的力的方向。
在第一比较步骤156中，处理器检查力的大小是否大于或等于预设的接触阈值。接触阈值的典型值为大约3g。如果力的大小小于接触阈值，则该方法返回步骤154。如果力的大小超出阈值，则处理器42继续进行到力和位移的测量步骤158。
当在步骤156中力的大小大于所用的接触阈值时，在力和位移测量步骤158中，处理器计算力的大小和方向的值。同时，处理器42使用来自位置传感器38的信号来评价探针远端的位置。假定该值是在本文称为测量期间的一段时间内测量的。处理器在存储器50中存储力的大小和方向的值以及位置的值。
在评价步骤160中，处理器分析存储器50中存储的值。
根据对位置值的分析，处理器从测量期间远端的最终位置与初始位置之间的差值确定远端的总位移向量位移向量具有方向和大小，并且本文将该方向假定为定义局部x轴的方向(如图3和4所示)。处理器还计算总位移的大小|ΔD|。坐标图120和140中使用了位移大小|ΔD|。
从对力测量值的分析，处理器确定在测量期间的力的方向。通常，对于无护套探针，力的方向平行于总位移的方向，即平行于局部x轴，如图3所示。通常，对于有护套探针，力的方向平行于护套，并且倾斜于局部x轴，如图4所示。
对于在测量期间测得的每个力测量值，处理器按方向和按大小计算|F|力向量处理器沿局部x轴分解力向量并且确定该力的分解的大小|FX|。(对于图3的正面情况，分解的力和未分解的力相等；然而，对于图4的倾斜情况，分解的力小于未分解的力。)从分别对应于远端的最终位置和初始位置的最终分解力的大小和初始分解力的大小，处理器计算分解力的大小的总变化|ΔFX|的值。坐标图140示出了分解的力的大小的变化|ΔFX|。坐标图120示出了总力的大小的变化|ΔF|，因为该坐标图是针对正面的情况|ΔF|≡|ΔFX|。
在第二比较步骤162中，处理器检验下列不等式是否有效：
|ΔD|＞D范围 (1)
|ΔFX|＞F范围 (2)
D范围和F范围为处理器42所用的和坐标图120和140所示的|ΔD|和|ΔFX|的预设最小范围。D范围和F范围的典型值分别为大约4mm和大约8g。处理器使用不等式(1)和(2)来确保用于检验不等式(3)的值不会太小。使用太小的值可能导致不等式(3)的检验受到诸如噪声的负面影响。
不等式(3)的有效性确定了|ΔD|和|ΔFX|之间的关系为数学上正相关的关系，从而随着位移的大小增加，分解的力的大小也增加。正相关关系由坐标图120和140示出。
应当理解，不等式(3)在患者心脏正常跳动和正常呼吸期间通常是无效的，在此期间，随着位移的大小增加，分解的力的大小减小，因此所述关系为负相关关系。这种负相关关系由坐标图125示出。因此，不等式(3)的有效性证明隆起正在发生，并且证明力和位移的变化不代表心脏的正常行为。
如果不等式(1)、(2)和(3)中的任一个无效，则流程图返回步骤154。
如果不等式(1)、(2)和(3)全部有效，则处理器前进到警告步骤164。
在警告步骤164中，处理器假设隆起可能正在发生，并且例如通过在显示器46上显示通知来向操作者30发出关于隆起可能正在发生的视觉和/或声音警告。处理器也可以通过使用存储在存储器50中的结果来计算隆起的尺寸，以找到隆起的组织的初始位置116(图3和4)(隆起开始的点)和隆起的组织的最终位置118，即所形成的隆起的顶点。尺寸可以包括在警告中。在一些实施例中，如果隆起尺寸大于预设值，则可以加强警告以反映可能的危险情况。危险的隆起尺寸通常取决于正在发生隆起的组织的厚度。组织的厚度可以是已知的，或者可以是例如从位置116的相关信息估计的。作为另外一种选择或除此之外，如果其中Q为通常大于2g/mm的正值，则可以假设出现危险情况。
如果处理器正在使用映射算法生成心内膜的位置的图，则通常进行任选的测绘步骤166(在流程图中用虚线显示为任选的)。在步骤166中，处理器用在步骤164中计算的隆起的组织的初始位置116替代隆起顶点的位置118，并且使用这个值作为组织的位置。所替代的位置被用于使用映射算法对图进行重新计算。
然后流程图150结束。
对流程图150的各步骤的描述假设了力传感器F所测得的力没有由于患者的心跳和/或呼吸而进行过任何校正。本发明的一些实施例可以例如通过测量或估计在多个心跳和呼吸周期内从“典型”心脏施加到力传感器的力，以便为该力传感器确定典型的力与时间的关系，从而应用这种校正。处理器可以利用该关系找到在隆起可能正在发生时的预期典型力测量值，并且从力传感器所测得的实际力中减去这些典型力测量值。然后，可以在上述不等式(2)和(3)中使用校正的力。
应当理解，上述实施例仅是以举例的方式进行的引用，并且本发明并不限于上文具体示出和描述的内容。相反，本发明的范围包括上述各种特征的组合和子组合以及它们的变型形式和修改形式，本领域技术人员在阅读上面的描述时将会想到所述变型形式和修改形式，并且所述变型形式和修改形式在现有技术中未公开。
Claims (9)
1.一种用于检测患者的组织的隆起的设备，包括：
探针，所述探针包括：
力传感器，所述力传感器被构造成测量由所述探针施加在所述组织上的力，和
位置传感器，所述位置传感器被构造成在所述力传感器测量所述力的同时测量所述探针的位移；和
处理器，所述处理器被构造成响应于所测得的力和所测得的位移之间的关系检测所述隆起，其中检测所述隆起包括确认所述关系包括所述所测得的力的变化的第一大小和所述所测得的位移的第二大小之间的数学上正相关的关系。
2.根据权利要求1所述的设备，其中所述处理器被构造成测量所述所测得的力在由所述所测得的位移定义的方向上的变化。
3.根据权利要求1所述的设备，其中测量所述力包括测量所述力的变化，并且其中检测所述隆起包括确定所述力的变化大于预设的力变化范围。
4.根据权利要求1所述的设备，其中检测所述隆起包括确定所述位移大于预设的位移范围。
5.根据权利要求1所述的设备，其中所述处理器被构造成响应于所述所测得的位移而测量所述隆起的尺寸。
6.根据权利要求1所述的设备，其中所述处理器被构造成响应于检测所述隆起而调节所述组织的坐标的图。
7.根据权利要求6所述的设备，其中所述组织的所述隆起包括所述组织中的锥形形成物，并且其中调节所述图包括将所述图制作成缺少所述锥形形成物的顶点的位置。
8.根据权利要求7所述的设备，其中制作所述图包括确定所述锥形形成物的底部的位置，并且在制作所述图的过程中使用所述底部的所述位置的坐标。
9.根据权利要求1所述的设备，其中所述处理器被构造成响应于所述患者的心跳和呼吸中的至少一项而校正所述所测得的力。
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- 2012-06-01 EP EP12170444.9A patent/EP2529667B1/en active Active
- 2012-06-01 JP JP2012125772A patent/JP6054064B2/ja active Active
- 2012-06-01 CN CN201210191871.7A patent/CN102805611B/zh active Active
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|---|---|
| US8523787B2 (en) | 2013-09-03 |
| EP2529667B1 (en) | 2016-12-28 |
| EP2529667A3 (en) | 2015-08-19 |
| EP2529667A2 (en) | 2012-12-05 |
| IL219844A0 (en) | 2012-07-31 |
| IL219844A (en) | 2016-03-31 |
| JP6054064B2 (ja) | 2016-12-27 |
| JP2012254295A (ja) | 2012-12-27 |
| US20120310116A1 (en) | 2012-12-06 |
| AU2012202969B2 (en) | 2014-10-30 |
| CA2778473A1 (en) | 2012-12-03 |
| CN102805611A (zh) | 2012-12-05 |
| AU2012202969A1 (en) | 2012-12-20 |
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