CN112998721A - 电生理参数的双选图形呈现 - Google Patents
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Abstract
本发明题为“电生理参数的双选图形呈现”。本发明提供了一种医疗设备，该医疗设备包括被配置为插入患者的身体中的探头。该探头包括被配置为接触身体内的组织的电极。该设备还包括显示屏、被配置为采集电极的位置坐标的位置跟踪系统，以及处理器。该处理器被配置为以时间间隔序列从电极组采集电生理信号，从信号中提取电生理参数，并且针对每个时间间隔，计算从信号中提取的参数的一致性量度。该处理器被进一步配置为将组织的三维标测图渲染到显示屏，同时在标测图上叠加一致性量度满足了一致性标准的所提取的参数的视觉指示，并且从标测图中自动丢弃一致性量度没有满足标准的参数。
Description
技术领域
本发明整体涉及电生理测量，并且具体地涉及用于电生理参数的自动标测的设备和方法。
背景技术
患者的组织的电生理(EP)标测图通过以下方式生成：将一个或多个电极定位在组织的区域上；采集该区域的EP信号；然后对不同区域重复该过程。EP参数从每个测量区域中的EP信号中提取，然后显示在组织的图像上。
发明内容
下文所述的本发明的实施方案提供了用于标测电生理参数的改进的方法和设备。
因此，根据本发明的实施方案，提供了一种医疗设备，该医疗设备包括被配置用于插入患者的身体中的探头。该探头包括被配置为以时间间隔序列接触身体内组织的多个电极。该设备还包括显示屏、被配置为采集身体内的这些电极的位置坐标的位置跟踪系统，以及处理器。
该处理器被配置为在电极接触组织的区内的相应位置处的该区时，在序列中的每个时间间隔从电极组采集相应的电生理信号，以从由组中的电极在每个时间间隔采集的相应的电生理信号中提取相应的电生理参数，并且针对每个时间间隔，计算从由组中的电极在时间间隔期间内采集的电生理信号中提取的相应的电生理参数之间的相应的一致性量度。该处理器被进一步配置为将组织的三维(3D)标测图渲染到显示屏，同时响应于位置坐标在标测图上叠加在相应的一致性量度满足了预定义一致性标准的时间间隔电极的相应位置处的所提取的电生理参数的视觉指示，并且从标测图中自动丢弃在相应的一致性量度没有满足预定义一致性标准的时间间隔提取的电生理参数。
在一些实施方案中，电生理参数包括患者的心脏中的局部激动时间(LAT)，并且一致性量度指示LAT的变化。在一个实施方案中，一致性量度包括LAT在任何给定时间间隔的峰到峰变化，并且一致性标准要求LAT的峰到峰变化不超过预定义限值。
另选地或除此之外，电生理参数包括电生理电压，并且一致性量度指示电生理电压的变化。在一个实施方案中，一致性量度包括电生理电压在任何给定时间间隔的峰到峰变化，并且一致性标准要求电生理电压的峰到峰变化不超过预定义限值。
在另一个实施方案中，以背景颜色渲染3D标测图，并且视觉指示包括在相应位置处叠加在背景颜色上的其他颜色以指示所提取的电生理参数的值。
根据本发明的实施方案，还提供了一种用于电生理标测的方法。该方法包括：在探头上的电极组接触患者身体内的组织的区时，以时间间隔序列从探头上的电极组采集相应的电生理信号，以及采集该电极组的位置坐标。从由该组中的电极在序列中的每个时间间隔采集的相应电生理信号中提取相应的电生理参数，并且针对每个时间间隔，计算从由该组中的电极在时间间隔期间采集的电生理信号中提取的相应的电生理参数之间的相应的一致性量度。该方法还包括：显示组织的三维(3D)标测图，同时响应于位置坐标在标测图上叠加在相应的一致性量度满足了预定义一致性标准的时间间隔相应位置处的所提取的电生理参数的视觉指示，并且从标测图中自动丢弃在相应的一致性量度没有满足预定义一致性标准的时间间隔提取的电生理参数。
结合附图，通过以下对本发明的实施方案的详细描述，将更全面地理解本发明，其中：
附图说明
图1是根据本发明的实施方案的用于标测患者的心脏中的EP参数的医疗设备的示意性图示；
图2是示意性地示出根据本发明的实施方案的用于自动EP标测的方法的流程图；并且
图3是根据本发明的实施方案的电解剖标测图的示意图。
具体实施方式
概述
生成患者的组织的电生理(EP)标测图涉及将一个或多个电极定位在组织的区域上，采集该区域的信号，然后针对不同区域重复该过程。当使用少量电极时，该过程生成从这些信号提取的EP参数的准确标测图，因为医师可观察所采集的信号，并且仅接受(如由医师判断的)“良好”信号用于标测图。只有当电极与组织良好接触时，才通常生成良好的信号。然而，使用少量电极具有需要很长时间来标测的缺点。
对于具有大量电极的导管，标测时间减少，但准确度降低，因为医师无法在可用时间内正确检测同时生成的所有信号。通过向医师呈现信号的分析结果，即跨测量区域的EP参数的值，可促进接受良好信号(并且拒绝其他信号)的任务。(为了简洁起见，“EP参数的值”将在以下描述中简称为“EP参数”。)通过以图形形式呈现这些值，诸如值的标测图，可以进一步促进任务。然而，医师仍然需要使用他/她的主观判断来接受或拒绝所分析的结果，因主观性而存在接受方面的固有可变性。此外，要求医师判断这些结果的质量将在标测规程中进一步消耗他/她的时间和注意力，尤其是在使用大量电极的情况下。
本文所述的本发明的实施方案通过提供包括探头、显示屏、位置跟踪系统和处理器的医疗设备来解决这些问题。将包括多个电极的探头插入患者的身体中，使得电极组接触身体内组织的区。该电极组可包括探头上的所有电极或电极的特定子集。(例如，该组可包括在篮式导管上的总共120个电极中接触心肌组织的特定区、通常为约1cm2至10cm2的区的20个电极。)当电极接触组织时，处理器以时间间隔序列诸如心跳序列从电极采集EP信号。同时，位置跟踪系统采集电极的位置坐标。
针对每个时间间隔，处理器从信号中提取相应的EP参数，并且计算组中的电极上的EP参数的值的一致性量度。为简明起见，在给定时间间隔从接触组织的区的电极组提取的EP参数将被称为“EP参数集”。处理器将组织的三维(3D)标测图渲染到显示屏，同时在标测图上叠加在一致性量度满足了预定义一致性标准的时间点处的EP参数集的视觉指示，诸如表示参数值的颜色。处理器从标测图中自动丢弃相应的一致性量度没有满足预定义标准的EP参数。
该方法有利于自动呈现有效EP参数的标测图，而不必依赖于医师对EP信号或参数的主观且耗时的评估。
在本发明所公开的实施方案中，处理器显示正在标测EP参数的心脏的腔室的3D标测图。3D标测图以中性色调诸如灰色呈现。EP参数可包括例如在心肌或双极性或单极性最大电压中测量的局部激动时间(LAT)。LAT是例如根据体表ECG或心内电描记图确定的参考时间与局部去极化事件的时间之间的时间间隔。生理参数的其他可用标量函数可被计算和显示，然后被叠加在LAT(如伪彩色)和/或传播速度(如箭头)的组合显示上。一种此类可用标量函数是在每个采样点处测量的电压范围(显示为伪彩色)：异常低的范围是疤痕组织的诊断，在疤痕组织上的传导速度可显示为箭头。例如可通过标记以下一项或多项来手动或自动确定LAT：(a)单极性记录的电压的最大负斜率(-dV/dt)；(b)双极性记录的最大绝对电压；(c)双极性记录的最大绝对斜率dV/dt；或(d)双极性记录的最小电压。(用于自动计算LAT的方法是本领域已知的，例如在由Biosense Webster Inc.,Irvine,California生产的
系统中实现。)
在心脏中的测量过程期间，处理器从接触组织的所有电极中提取若干(例如3个至7个)心跳中的每个心跳中的EP参数集。(另选地，测量的时间间隔可与心跳无关。)由于与心脏的腔室相比电极接触组织的面积小，因此预计一个集内的EP参数彼此之间仅差异较小的量。因此，一个集中的EP参数之间的较大波动是EP信号采集不当的指示。EP信号采集不当的原因可能是例如一个或多个电极与组织之间的接触不良。为了识别和拒绝不当采集的EP信号，处理器计算每个EP参数集内的一致性量度。一致性量度可为例如电极组上的EP参数集内的峰到峰变化。
处理器拒绝一致性量度没有满足预定义一致性标准的EP参数集，而其接受满足一致性标准的EP参数。处理器通过将叠层叠加在标测图上来更新3D标测图，从而指示所接受的EP参数集的值。指示可为例如色码，其中EP参数的最低值由蓝色表示，最高值由红色表示，并且中间值由蓝色和红色之间的可见光谱的颜色表示。当在给定区接受若干个EP参数集时，处理器可将3D标测图与例如所接受集的平均值叠加。另选地，处理器可一个接一个地将所接受集叠加在标测图上，或者仅用所接受集中的一个集对其叠加。
系统描述
图1是根据本发明的实施方案的用于标测患者28的心脏26中的EP参数的医疗设备20的示意图。
医师30通过使用靠近导管的近侧端部的操纵器32操纵轴22和/或从护套23的挠曲来将详细地示于插图45中的篮式导管40导航到患者28的心脏26中的目标位置。在插图25中看到的实施方案中，医师30使用导管40来执行心腔的电解剖标测。通过使用篮式导管40上接触区46中组织的电极48的组从组织采集EP信号，如下文进一步详述。当使用篮式导管时，电极组通常为电极48的总数的较小子组，例如总共120个电极中的20个电极。
导管40以塌缩构型插入护套23中，并且仅在导管退出护套23之后，导管才膨胀到其预期的功能形状，如插图45所示。通过将导管40包含在塌缩配置中，护套23还用于使在其到目标位置的途径上的血管创伤最小化。
篮式导管40在轴22的远侧边缘处(即，篮式导管40的近侧边缘处)结合磁性传感器50A(参见插图45)。通常，尽管不是必需的，但传感器50A是三轴线传感器(TAS)，包括在不同方向上取向的三个微型线圈。在图示的实施方案中，第二磁性传感器50B被结合在篮式导管的远侧边缘中。传感器50B可以是例如单轴线传感器(SAS)或三轴线传感器(TAS)。另选地，导管40可包括在这些位置或其他位置处的其他种类的磁性传感器。
导管40还包括多个可膨胀脊55，这些可膨胀脊可以是机械挠性的，多个电极48(例如，总共120个电极)与每个可膨胀脊联接。电极48被配置为接触患者28的组织以感测EP信号。磁性传感器50A和磁性传感器50B以及电极48通过穿过轴22的导线连接到控制台24中的各种处理电路。
另选地，设备20可包括其他类型的导管，以及其他类型的电极阵列，诸如在外表面上具有电极48的可充胀球囊导管。
医疗设备20包括磁感测子系统，用于确定篮式导管40的位置和取向，从而确定电极48的位置。将患者28放置在由包含磁场发生器线圈42的垫所产生的磁场中，该磁场发生器线圈由控制台24中的跟踪模块43驱动。由线圈42生成的磁场在传感器50A和传感器50B中引起指示传感器的位置和/或取向的电信号。来自传感器50A和传感器50B的信号被传输回跟踪模块43，该跟踪模块将信号转换为到处理器41的对应的数字输入。处理器41使用这些输入来计算篮式导管40的位置和取向，从而找到电极48中的每个电极的相应位置。
使用外部磁场和磁性传感器(诸如传感器50A和传感器50B)进行位置和/或取向感测的方法在各种医疗应用中实现，例如在购自Biosense Webster,Inc.(加利福尼亚欧文市(Irvine,California))的
系统中实现。此类方法在美国专利5,391,199、6,690,963、6,484,118、6,239,724、6,618,612和6,332,089，PCT专利公布WO 96/05768和美国专利申请公布2002/0065455A1、2003/0120150A1和2004/0068178A1中进行了详细描述，这些专利的公开内容以引用方式全文并入本文并在附录中提供了副本。
另选地或除此之外，设备20可使用其他位置感测方法来找到电极48的位置。例如，处理器41可通过测量电极48和体表电极49之间的阻抗来标测电极48的位置，该电极和体表电极被放置在患者28的胸部上并且由引线39连接到控制台24。
处理器41另外经由电接口44接收电生理信号，并且使用包含在这些信号中的信息连同由磁性传感器50A和磁性传感器50B提供的坐标来构造导管40所处的心脏26的腔室的电解剖标测图31。在该规程期间和/或之后，处理器41可将电解剖标测图31渲染到显示屏27(在图3中进一步详细描绘)。
处理器41通常在软件中编程以执行本文所述的功能。该软件可通过网络以电子形式被下载到计算机，例如或者其可另选地或另外地设置和/或存储在非临时性有形介质(诸如磁存储器、光存储器或电子存储器)上。具体地，处理器41运行使得处理器能够执行本发明所公开的步骤的专用算法，如下所述。
图1所示的示例性图示完全是为了概念清晰而选择的。为简单和清晰起见，图1仅示出了与本发明所公开的技术有关的元件。医疗设备20通常包括附加的模块和元件，这些附加的模块和元件与本发明所公开的技术不直接相关，并且因此从图1和对应的描述中被有意地省略。医疗设备20的元件以及本文所述的方法可进一步应用于例如控制心脏26的组织的消融。
EP参数的测量和显示
图2是示意性地示出根据本发明的实施方案的用于EP标测的自动化过程的流程图200。在该方法中，仅当来自区46的EP参数满足特定一致性标准时才将这些参数纳入标测图中。流程图200中所示的实施方案是指从心脏26的腔室采集EP信号的示例(参照图1)。在另选的实施方案中，EP参数值可使用其他种类的标测设备来采集，不仅从心脏采集，还从其他器官和组织采集，这对于阅读本说明书之后的本领域的技术人员而言将是显而易见的。
流程图200所示的过程从开始步骤202开始。在标测图生成步骤204中，由处理器41生成心室的均匀灰色(或其他合适的背景颜色的)3D标测图并且将其渲染到显示屏27上。3D标测图例如从先前存储在处理器中的心脏26的图像生成，或者基于由导管获取的位置测量来生成。另选地，3D标测图可在显示EP参数的同时生成。在导管定位步骤206中，医师30将导管40定位在心脏26中，使得电极48的组与心脏腔室的区46中的心肌组织接触。在采集步骤208中，处理器41在单个时间间隔(诸如单次心跳)期间从电极48的组接收信号。在跟踪步骤209中，处理器41从跟踪模块43接收信号，并且计算电极48的相应位置坐标。在提取步骤210中，处理器41从在采集步骤208中接收的信号中提取EP参数集。
在一致性计算步骤212中，处理器41计算在提取步骤210中提取的EP参数集的一致性量度。一致性量度以及一致性标准在本实施方案中根据给定集中的EP参数的峰到峰变化来定义。例如，当在步骤210中计算的EP参数是局部激动时间(LAT)时，一致性标准可采用±10ms的范围，即，如果集内的LAT彼此相差在20ms内，则认为它们满足一致性标准。又如，当EP参数是由电极48感测的信号中的双极性或单极性最大电压时，一致性标准可采用20mV的范围，使得该范围内的所测量的最大电压被认为满足一致性标准。另选地，可将参数的较大或较小范围视为一致性标准。
另选地，可应用其他种类的一致性标准。例如，处理器41可计算所考虑的EP参数的平均值和心跳序列的参数的方差，并且可根据最大可接受方差来定义一致性标准。
在第一决策步骤214中，处理器41将在步骤212中计算的一致性量度与预定义一致性标准进行比较。如果一致性量度满足一致性标准，则在包括步骤216中，处理器41将EP参数集包括在所接受集中。如果一致性量度没有满足标准，则在丢弃步骤218中，处理器41丢弃EP参数集。
从包括步骤216和丢弃步骤218两者，过程继续到第二决策步骤220，其中处理器41基于预设标准确定是否要从当前区46采集更多EP参数集。如果例如一致性量度没有满足从当前区46采集的EP参数集中的任一个集的一致性标准，则可能需要另外的采集。另选地或除此之外，可能需要另外的采集以便对大量所接受集求平均值。当需要更多采集时，过程返回到步骤208。
当不需要更多采集时，可任选地在平均步骤222中对在步骤216中收集的EP参数集求平均值。另选地，可绕过平均步骤222，并且可选择所接受EP参数集中的仅一个集用于输出。在显示步骤224中，将所得EP参数的表示(已求平均值或未求平均值)叠加在3D标测图上。在显示步骤224中，基于在跟踪步骤209中接收的位置坐标，处理器41例如通过将对应的色码应用于在步骤204中生成的3D标测图的适当区域来显示EP参数。颜色编码可包括例如将EP参数的最低值显示为蓝色，将最高值显示为红色，并且将最低值和最高值之间的中间值以与可见光谱中的颜色顺序相同的顺序显示。然而，可另选地使用诸如本领域中已知的其他颜色编码方案以及其他类型的阴影或符号。
在显示步骤224之后，过程继续到第三决策步骤226，其中医师30决定是否将另外的区包括在标测中。如果决定是肯定的，则医师30在步骤206中将导管40移动到新区46中，并且过程从该处继续，如上所述。当医师30确定标测已完成时，过程在结束步骤228中结束。
图3是根据本发明的实施方案的电解剖标测图31的示意图。在步骤204(图2)之后，3D标测图300初始在显示屏27上以中性颜色诸如灰色显色。当由篮式导管40采集的EP参数满足适用的一致性标准时，根据图2的方法将有色叠层302叠加在3D标测图300上。
尽管上述实施方案涉及在心脏26中的EP参数的测量，但在另选的实施方案中，所述的自动接受或拒绝EP参数的方法可应用于患者28的身体的其他组织。此外，在另选的实施方案中，可同时测量和显示不止一种类型的EP参数。
因此应当理解，上面描述的实施方案以举例的方式被引用，并且本发明不限于上文特定示出和描述的内容。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和修改，本领域的技术人员在阅读上述说明时应当想到所述变型和修改，并且所述变型和修改并未在现有技术中公开。
Claims (12)
1.一种医疗设备，所述医疗设备包括：
探头，所述探头被配置用于插入患者的身体中，并且包括被配置为以时间间隔序列接触所述身体内组织的多个电极；
显示屏；
位置跟踪系统，所述位置跟踪系统被配置为采集所述电极在所述身体内的位置坐标；以及
处理器，所述处理器被配置为：
在所述电极在所述组织的区内的相应位置处接触所述区时，在所述序列中的每个时间间隔从所述电极的组采集相应的电生理信号；
从由所述组中的所述电极在每个时间间隔采集的所述相应的电生理信号中提取相应的电生理参数；
针对每个时间间隔，计算从由所述组中的所述电极在所述时间间隔期间采集的所述电生理信号中提取的所述相应的电生理参数之间的相应的一致性量度；以及
将所述组织的三维(3D)标测图渲染到所述显示屏，同时响应于所述位置坐标在标测图上叠加在所述相应的一致性量度满足了预定义一致性标准的所述时间间隔所述电极的所述相应位置处的所提取的电生理参数的视觉指示，并且从所述标测图中自动丢弃在所述相应的一致性量度没有满足所述预定义一致性标准的所述时间间隔提取的所述电生理参数。
2.根据权利要求1所述的医疗设备，其中所述电生理参数包括所述患者的心脏中的局部激动时间(LAT)，并且所述一致性量度指示所述LAT的变化。
3.根据权利要求2所述的医疗设备，其中所述一致性量度包括所述LAT在任何给定时间间隔的峰到峰变化，并且所述一致性标准要求所述LAT的所述峰到峰变化不超过预定义限值。
4.根据权利要求1所述的医疗设备，其中所述电生理参数包括电生理电压，并且所述一致性量度指示所述电生理电压的变化。
5.根据权利要求4所述的医疗设备，其中所述一致性量度包括所述电生理电压在任何给定时间间隔的峰到峰变化，并且所述一致性标准要求所述电生理电压的所述峰到峰变化不超过预定义限值。
6.根据权利要求1所述的医疗设备，其中以背景颜色渲染所述3D标测图，并且所述视觉指示包括在所述相应位置处叠加在所述背景颜色上的其他颜色以指示所提取的电生理参数的值。
7.一种用于电生理标测的方法，所述方法包括：
在探头上的电极组接触患者的身体内的组织的区时，以时间间隔序列从所述探头上的电极组采集相应的电生理信号；
采集所述电极组的位置坐标；
从由所述组中的所述电极在所述序列中的每个时间间隔采集的所述相应的电生理信号中提取相应的电生理参数；
针对每个时间间隔，计算从由所述组中的所述电极在所述时间间隔期间采集的所述电生理信号中提取的所述相应的电生理参数之间的相应的一致性量度；以及
显示所述组织的三维(3D)标测图，同时响应于所述位置坐标在所述标测图上叠加在所述相应的一致性量度满足了预定义一致性标准的所述时间间隔所述相应位置处的所提取的电生理参数的视觉指示，并且从所述标测图中自动丢弃在所述相应的一致性量度没有满足所述预定义一致性标准的所述时间间隔提取的所述电生理参数。
8.根据权利要求7所述的方法，其中提取电生理参数包括提取所述患者的心脏中的局部激动时间(LAT)，并且计算所述一致性量度包括计算指示所述LAT的变化的量度。
9.根据权利要求8所述的方法，其中计算所述量度包括计算所述LAT在任何给定时间间隔的峰到峰变化，并且其中所述一致性标准要求所述LAT的所述峰到峰变化在该时间间隔期间不超过预定义限值。
10.根据权利要求7所述的方法，其中提取电生理参数包括提取所述患者的心脏中的电生理电压，并且计算所述相应的一致性量度包括计算指示所述电生理电压的变化的量度。
11.根据权利要求10所述的方法，其中计算所述量度包括计算所述电生理电压在任何给定时间间隔的峰到峰变化，并且其中所述一致性标准要求所述电生理电压的所述峰到峰变化在该时间间隔期间不超过预定义限值。
12.根据权利要求7所述的方法，其中显示所述3D标测图包括以背景颜色渲染所述3D标测图，并且叠加所述视觉指示包括在所述相应位置处在所述背景颜色上叠加其他颜色，从而指示所提取的电生理参数的相应值。
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114209331A (zh) * | 2021-12-29 | 2022-03-22 | 四川锦江电子科技有限公司 | 一种球形多极标测头端及标测导管 |
| CN114209331B (zh) * | 2021-12-29 | 2024-02-09 | 四川锦江电子医疗器械科技股份有限公司 | 一种球形多极标测头端及标测导管 |
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| IL279513B1 (en) | 2023-08-01 |
| US11918341B2 (en) | 2024-03-05 |
| IL279513A (en) | 2021-06-30 |
| EP3838151A1 (en) | 2021-06-23 |
| IL279513B2 (en) | 2023-12-01 |
| EP3838151B1 (en) | 2024-02-28 |
| EP3838151C0 (en) | 2024-02-28 |
| US11517218B2 (en) | 2022-12-06 |
| JP2021098016A (ja) | 2021-07-01 |
| US20210186363A1 (en) | 2021-06-24 |
| US20230083715A1 (en) | 2023-03-16 |
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