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CN105979868A - 用于血管内装置的导向和放置的系统和方法 - Google Patents

用于血管内装置的导向和放置的系统和方法 Download PDF

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CN105979868A
CN105979868A CN201580007645.0A CN201580007645A CN105979868A CN 105979868 A CN105979868 A CN 105979868A CN 201580007645 A CN201580007645 A CN 201580007645A CN 105979868 A CN105979868 A CN 105979868A
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CN105979868B (zh
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V·布克霍曼
A·K·米森纳
V·瓦瑟利耶夫
R·S·厄里
B·S·坦纳
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Abstract

公开了一种用于协助临床医生将导管或其它医疗装置放置在患者血管内部的导向和放置系统以及相关的方法。在一个实施方式中，还公开了一种用于将医疗装置导向至患者的血管内期望位置的方法，该方法包括检测该患者的血管内ECG信号，和识别所述血管内ECG信号的波形的P‑波，其中，所述P‑波根据所述医疗装置到期望位置的接近度而变化。该方法进一步包括确定所述被识别的P‑波是否是升高的、确定在所述被识别的P‑波是升高的时所述被识别的P‑波的偏移值、以及至少部分地根据所述被确定的升高的P‑波的偏移值来报告与所述医疗装置在所述患者的血管内的位置相关的信息。

Description

用于血管内装置的导向和放置的系统和方法
相关申请的交叉引用
本申请要求2014年2月6日提交的、名称为“用于血管内装置的导向和放置的系统和方法(SYSTEMS AND METHODS FORGUIDANCE AND PLACEMENT OF AN INTRAVASCULARDEVICE)”的美国临时专利申请No.61/936,825的权益，其全部内容在此通过引用并入本文。
发明内容
简要概括如下，本发明的实施方式针对一种导向和放置系统以及相关方法，该系统用于协助临床医生在患者的血管内部放置导管或其它医疗装置。该导向和放置系统利用由心脏产生的ECG信号，使得导管的远侧尖端能够以与患者的心脏的期望的接近度被放置在患者的血管内部。
在一个实施方式中，公开了一种用于将医疗装置导向至患者血管内部的期望位置的方法。该方法包括检测患者的血管内ECG信号和识别该血管内ECG信号波形的P-波，其中，该P-波根据医疗装置距期望位置的接近度而变化。
该方法进一步包括确定该被识别的P-波是否升高、确定当该被识别的P-波升高时该被识别的P-波的偏移值(deflection value)、以及至少部分地依据所确定的该升高的P-波的偏移值来报告关于医疗装置在患者血管内部的位置的信息。
在一个实施方式中，该导管在患者身体内的预期目的地使得该导管的远侧尖端被布置在上腔大静脉(superior vena cava,“SVC”)的近底部1/3部分处。该导向和放置系统分析患者的ECG信号来确定导管在何时到达其在血管内部的预期目的地，然后通过例如显示器来告知临床医生。因此，该系统包括用于协助医疗装置在患者体内放置的ECG模式。
本发明实施方式的这些和其它特征将由以下说明书和所附的权利要求书而变得更加充分地清楚明白，或者可以从如下文陈述的本发明实施方式的实例中获知。
附图说明
将参考在附图中进行说明的本公开内容的具体实施方式来给予本公开内容更加具体的描述。应当领会到的是，这些附图仅仅描绘了本发明典型的实施方式，并且因此不能被认为是对本发明范围的限制。将通过使用以下附图结合附加的特征和细节来对本发明的示例性实施方式进行描述和解释，以下附图为：
图1是示出根据一个实施方式的导向和放置系统的各个部件的框图；
图2示出正在用于导向导管插入和放置到患者的身体中的图1的系统；
图3示出ECG复合波(ECG complex)的各个细节；
图4示出ECG描记线(ECG trace)的各个细节；
图5是示出根据一个实施方式的导向和放置系统的各个方面的框图；
图6是示出根据一个实施方式的用于导向医疗装置的方法的各个阶段的框图；
图7示出根据一个实施方式的被捕获的血管内ECG复合波的各个细节；
图8示出根据一个实施方式的被捕获的血管内ECG复合波的各个细节；
图9示出根据一个实施方式的用于给导向和放置系统确定显示输出的决策树；
图10A-10C示出根据一个实施方式的导向和放置系统的显示器的各个屏幕截图；
图11是示出根据一个实施方式的用于导向医疗装置的方法的各个阶段的框图；
图12是根据一个实施方式的具有叠加到其上的可能的报告区域的心脏的简化视图；和
图13示出根据一个实施方式的用于给导向和放置系统确定显示输出的决策树。
具体实施方式
现在将参看附图，其中，相似的参考编号将被提供给相似的结构。应当理解的是，附图是本发明示例性实施方式的概略的和示意性呈现，并且既不是限制性的，也没有必要按比例绘制。
为了清楚，应当理解的是，词语“近侧的”是指相对更靠近使用本文将要描述的装置的临床医生的方向，而词语“远侧的”是指相对更远离临床医生的方向。例如，导管被放置在患者的体内的端被认为是该导管的远侧端，而保持在身体外的导管端是该导管的近侧端。而且，本文和权利要求书所使用的词语“包括”、“有”和“具有”应具有和词语“包含”相同的意思。
本发明的实施方式主要是针对一种导向和放置系统，在本文还被称为“放置系统”或“系统”，该导向和放置系统用于协助临床医生在患者的身体内，诸如血管内部，放置导管或其它医疗装置。在一个实施方式中，该导向和放置系统利用该患者的心脏产生的ECG信号，使得导管的远侧尖端能够以与患者心脏的期望的接近度被放置在患者血管内。在一个实施方式中，该医疗装置包括导管，并且导管在患者身体内的预期目的地使得该导管的远侧尖端被布置在上腔大静脉(“SVC”)的近底部1/3部分处。该导向和放置系统分析患者的ECG信号，从而确定导管在何时到达其在血管内部的预期目的地，然后通过例如显示器来告知临床医生。因此，该系统包括用于协助医疗装置在患者体内放置的ECG模式。
在一个实施方式中，以上提到的导向和放置系统的ECG导向模式伴有超声(“US”)模式以协助医疗装置进入身体的初始插入，还伴有基于磁元件的跟踪或尖端定位系统(“TLS”)模式以在医疗装置朝向其预期目的地推进时追踪该医疗装置的位置和方向。
首先参看描绘放置系统(“系统”)的各个部件的图1和图2，该放置系统被普遍指定为10并且根据本发明的一个示例性实施方式被构造。如图所示，系统10主要包括控制台20、显示器30、探测器40和传感器50，它们中的每一个在下文被更详细地描述。
图2示出在通过皮肤插入位点73将导管72放置进患者血管的过程中这些部件与患者70的大致关系。图2示出导管72主要包括保持在患者外部的近侧部分74和放置完成之后驻留在患者血管内部的远侧部分76。在该实施方式中，采用系统10来将导管72的远侧尖端76A最终定位在患者血管内部的期望方位(position)。在一个实施方式中，导管远侧尖端76A的期望方位接近患者的心脏，诸如在上腔大静脉(“SVC”)的近底部1/3部分处。当然，可以采用系统10来将导管远侧尖端放置在其它位置。导管近侧部分74进一步包括提供导管72的一个或多个管腔之间液体流通的枢纽74A，以及从该枢纽向近侧延伸的一个或多个延长腿74B。
例如，包括诸如EEPROM的非易失性存储器的处理器22被包括在控制台20中，用于在系统10的运行期间控制系统功能，由此充当控制处理器。数字控制器/模拟接口24也被包括在控制台20中并且与处理器22以及其它系统部件通讯，从而控制探测器40、传感器50以及其它系统部件之间的接合。
系统10进一步包括用于与传感器50和任选的部件54连接的端口52，其中任选的部件54包括打印机、存储媒介、键盘等。在一个实施方式中该端口是USB端口，但其它端口类型或端口类型的组合可以用于这里以及本文所描述的其它接口连接。电源连接56被包括在控制台20中，以使得可操作的连接至外部电源58成为可能。也可以采用内部电池60，包括或不包括外部电源均可。电源管理电路59被包括在控制台的数字控制器/模拟接口24中，以调节电源使用和分配。
该实施方式中的显示器30被集成到控制台20并且被用于在导管放置过程期间向临床医生显示信息。在另一个实施方式中，显示器可以与控制台分离开。如将被看到的那样，显示器30所描绘的内容随着导管放置系统所处的模式而改变：这些模式为US、TLS或其它实施方式中的ECG尖端确认。在一个实施方式中，控制台按钮界面32和包括在探测器40上的按钮可以被临床医生用于立即唤起想要的模式到显示器30来协助放置过程。在一个实施方式中，来自诸如TLS和ECG的多个模式的信息可以同步地显示。因此，系统控制台20的单独显示器30可以用于在进入患者血管过程中的超声导向、导管穿过血管推进期间的TLS导向、以及(如后面的实施方式所示)导管远侧尖端相对于患者心脏结节放置的基于ECG的确认。在一个实施方式中，显示器30是LCD装置。
探测器40与上文提到的第一模式一起用于为导管72插入到血管中做准备，该第一模式即，基于超声(“US”)的血管(诸如静脉)可视化。这样的可视化给出用于将导管引入患者的血管中并且有助于降低通常与这样的引入相关的并发症(包括不经意的动脉穿刺、血肿、气胸等等)的实时超声导向。
同样地，在一个实施方式中，临床医生采用该第一、US模式来确定合适的插入位点，并且用诸如针和插管器、然后用导管来建立血管通路。然后，临床医生可以通过推动探测器按钮板上的按钮无缝地切换到第二、TLS模式，而不必伸出到无菌区以外。然后，可以使用该TLS模式来协助导管72穿过血管朝向预期目的地的推进。
图1示出探测器40进一步包括按钮和用于控制按钮和探测器运行的存储控制器42。该按钮和存储控制器42可以包括非易失性存储器，诸如在一个实施方式中的EEPROM。该按钮和存储控制器42与控制台20的探测器接口44可操作的通信，该探测器接口44包括用于与探测器压电阵列接合的压电式输入/输出部件44A，以及用于与按钮和存储控制器42接合的按钮和存储器输入/输出部件44B。
需要注意的是，虽然在以US模式使用系统10期间通常在显示器30上描绘静脉，但是在其它实施方式中其它身体管腔和部分也可以被成像。需要注意的是，如果需要，US模式可以与其它模式(诸如TLS模式或ECG模式)同步地在显示器上描绘。除了视觉显示器30，系统10也可以采用诸如哔哔声、音调等等的听觉信息或者基于振动/运动的提示来在导管放置期间协助临床医生。另外，包括在探测器40和控制台按钮界面32上的按钮可以以多种方式来构造，除了按钮之外包括使用诸如滑动开关、拨动开关、电子或触摸感应板等等的用户输入控制。此外，在使用系统10期间，US、TLS和ECG的激活可以同步地或唯一地发生。
如刚刚所描述的，手持式超声探测器40作为集成式导管放置系统10的一部分被用于在导管经皮引入的准备中使得患者外周血管的US可视化成为可能。然而，如下文所述，在该示例性实施方式中，该探测器还用于在将导管朝向血管内部的其期望目的地导航时控制系统10的TLS部分或第二模式的功能。另外，由于探测器40在患者的无菌区内使用，这一特征使得TLS功能能够在无菌区内被完全控制。因此，探测器40是使得从无菌区对系统10的US和TLS功能二者进行方便控制成为可能的双重目的装置。如下文进一步所述，在一个实施方式中，该探测器还可以用于控制导管放置系统10的ECG相关功能或第三模式的一些或全部。
该导管放置系统10进一步包括上文提到的第二模式，即，基于磁力的导管TLS、或尖端定位系统。TLS使得临床医生能够在初始放置进入和穿过患者70的血管推进期间快速定位和确认导管72的方位和/或朝向，导管诸如为经外周插入的中心导管(“PICC”)、中心静脉导管(“CVC”)、或其它合适的导管或医疗装置。具体地，TLS模式检测由配备有磁元件的尖端定位探针(stylet)产生的磁场，由此使得临床医生能够探明导管尖端在患者身体内的大致位置和朝向，该尖端定位探针在一个实施方式中被预加载到导管72的沿纵向界定的管腔中。在一个实施方式中，磁组件可以使用以下美国专利No.5,775,322；5,879,297；6,129,668；6,216,028；和6,263,230中的一个或多个中的教导被追踪。上述美国专利的内容通过引用以它们的全部并入本文。TLS还显示导管尖端所指的方向，由此进一步协助准确的导管放置。TLS进一步协助临床医生确定导管尖端位置不正的发生，诸如在尖端已偏离期望的静脉路径进入另一静脉的情况下。
如所提到的，TLS利用探针来使得导管72的远侧端能够在其穿过血管推进期间被追踪。在一个实施方式中，该探针包括近侧端和远侧端，具有包括在远侧端处的手柄和从其向远侧延伸的芯线。磁组件被布置在芯线的远侧。该磁组件包括接近探针远端彼此毗邻布置的并且由管封装的一个或多个磁元件。在该实施方式中，包括多个磁元件，每个元件包括固态的、圆柱形的、与另一个磁元件端对端地堆叠的铁磁体。粘性尖端可以在磁元件的远侧填充管的远侧尖端。
需要注意的是，在其它实施方式中，磁元件可以不仅在形状上，而且在构成、数量、尺寸、磁类型以及在探针远侧段的位置上不同于该设计。例如，在一个实施方式中，多个铁磁体磁元件被替换为诸如电磁线圈的电磁组件，该电磁组件产生用于被传感器检测的磁场。本文可使用的组件的另一实例可以见于名称为“医疗器械定位方法(Medical Instrument Location Means)”的美国专利No.5,099,845，该专利通过引用以其全部并入本文。然而，可用于TLS模式的包括磁元件的探针的其它实例可见于名称为“探针仪器和制造方法(StyletApparatuses and Methods of Manufacture)”的美国专利No.8,784,336，该专利通过引用以其全部并入本文。因此，这些和其它变体被本发明的实施方式所考虑。在此应当领会到的是，如本文所使用的“探针”可以包括多种装置中的任何一种，该多种装置被构造成用于在导管的管腔内可移除的放置从而协助将该导管的远侧端放置在患者血管内部的期望位置。在一个实施方式中，探针包括导丝。
图2示出探针130大致上在导管72中的管腔内的布置，使得其近侧部分从该导管管腔穿过枢纽74A并由延长腿74B中选定的一个穿出从而向近侧延伸。如此布置在导管的管腔内，在该实施方式中的探针100的远侧端100B大致上与远侧导管端76A具有共同终端，从而使得由TLS对探针远侧端的检测相应地指示导管远侧端的位置。在其它实施方式中，探针与导管或医疗装置的远侧端之间可能有其它的方位关系。
TLS传感器50被系统10在TLS运行期间所采用，以检测由探针130的磁元件所产生的磁场。如在图2中所见的，TLS传感器50在导管插入期间被放置在患者的胸部上。TLS传感器50在预定的位置(诸如通过使用外部身体标志)被定位在患者的胸部上，以使得如上文所描述的被布置在导管72中的探针磁元件的磁场在导管穿过患者血管而通过期间能够被检测。另外，由于在一个实施方式中(图2)探针磁组件的磁元件与导管72的远侧端76A具有共同终端，由TLS传感器50对磁元件的磁场的检测给临床医生提供了关于其通过期间导管远侧端的方位和朝向的信息。
更详细地，TLS传感器50通过端口52中的一个或多个被可操作地连接至系统10的控制台20，如图1所示。需要注意的是，TLS传感器和系统控制台之间的其它连接方案也可以没有限制地使用。如刚刚所描述的，磁元件被用于探针130中以使得导管远侧端76A(图2)相对于放置在患者胸部上的TLS传感器50的方位能够被观察到。在TLS模式期间，由TLS传感器50对探针磁元件的检测通过图表显示在控制台20的显示器30上。这样，放置该导管的临床医生能够大致确定导管远侧端76A在患者血管内部相对于TLS传感器50的位置，并且检测导管位置不正，诸如导管沿非期望的静脉推进的发生。
如以上所讨论的，在该实施方式中系统10包括额外的功能，其中，导管远侧端76A相对于患者70的窦房结(“SA”)或其它发送电脉冲的心脏结节的接近度的测定可以被确定，由此提供将导管远侧尖端准确地放置在接近该结节的期望位置的增强的能力。在本文还被称为“ECG”或“基于ECG的尖端信息”的系统10的该第三模式使得能够检测来自窦房结的ECG信号，从而将导管远侧尖端放置在患者血管内部的期望位置。需要注意的是，US模式、TLS模式和ECG模式在该系统10中被无缝地结合，但是可以一齐或单个地用于协助导管放置。在一个实施方式中，应当理解的是，如本文所描述的ECG模式可以被包括在不包含US和TLS模式的独立系统中。因此，描述本文的实施方式的环境被理解为仅仅是示例性的环境，并且不被认为是对本公开内容的限制。
如所描述的，导管探针130被可移除地预先布置在通过插入位点73被插入患者70体内的导管72的管腔内。探针130除了包括用于基于磁力的TLS模式的磁组件之外，还包括接近其远侧端的传感部件，即，内部的血管内ECG传感器组件，并且包括与导管尖端的远侧端具有共同终端的部分，在该实施方式中当导管72和随附的探针130被布置在患者血管内部时，该血管内ECG传感器组件用于在血管内感应由窦房结产生的ECG信号。血管内ECG传感器组件在本文也被称为内部或血管内ECG传感器部件。
探针130包括从它的近侧端延伸的绳(tether)134，它的近侧端可操作地连接至TLS传感器50，但是也考虑了至系统10的其它连接方案。如将要被更详细地描述的，探针绳134允许ECG信号被包括在探针130的远侧部分上的ECG传感器组件所检测，从而在确定导管尖端位置的过程中作为基于ECG信号的尖端确认模式的一部分被传递到TLS传感器50。
在该实施方式中，外部参考和接地ECG电极136附接至患者70的身体，并且被可操作地附接至TLS传感器50以提供外部基线ECG信号给系统10，并使得该系统能够滤除与心脏窦房结的电活动不相关的高水平电活动，由此使得基于ECG的尖端确认功能成为可能。如所示出的，在该实施方式中，一个外部电极136被放置在靠近右上侧肩部(“右臂”放置)的患者皮肤上，而另一外部电极靠近左下侧腹部(“左腿”放置)而被放置。这种电极布置提供了根据心电描记法的艾因托文氏三角(Einthoven’s triangle)的导联(lead)II配置。外部电极136与传感器50的可操作地附接使得ECG信号能够被外部电极检测从而被传递至系统10的控制台20或其它合适的目的地。如此，外部电极136充当外部ECG传感器部件的一个实例。用于在患者身体外部检测基线ECG信号的其它外部传感器也可以用于其它实施方式中。此外，也可能有其它的电极位置。
与从外部ECG传感器部件(即，放置在患者皮肤上的外部ECG电极136)接收到的外部ECG信号一起，由内部ECG传感器部件(即，探针130的探针ECG传感器组件)感应到的内部的、血管内ECG信号被定位在患者胸部上的TLS传感器50(图10)或系统10的其它指定的部件所接收。TLS传感器50和/或控制台处理器22可以处理外部和内部ECG信号数据以在显示器30上产生包括一系列离散的ECG复合波的一个或多个心电图描记，如将被描述的那样。在TLS传感器50处理外部和内部ECG信号数据的情况下，处理器被包括在其中以执行预期的功能。如果控制台20处理ECG信号数据，处理器22、控制器24或其它处理器可以被使用在控制台中以处理该数据。
因此，由于它经由患者血管而推进，如上文所述的装配有探针130的导管72可以在如图10所示定位在患者胸部上的TLS传感器50之下推进。这使得TLS传感器50能够检测探针130(上文进一步描述)的磁组件的方位，在位于患者的血管内部时，该探针130的磁组件实质上与导管的远侧尖端76A具有共同终端。由TLS传感器50对探针磁组件的检测在ECG模式期间被描绘在显示器30上。
在ECG模式期间，显示器30可以进一步描绘由于患者心脏电活动而产生的一个或多个ECG心电图描记，如上文所描述的，患者心脏电活动被外部和内部ECG传感器部件所检测。更详细地，窦房结的ECG电活动(包括描记中的P-波)被外部和内部传感器部件所检测并且被发送至TLS传感器50和控制台20。然后，ECG电活动被处理以描绘在显示器30上，如下文将进一步描述的那样。
然后，放置导管的临床医生可以观察协助确定导管72的远侧尖端76A的最佳放置(诸如，例如接近窦房结)的ECG数据。在一个实施方式中，控制台20包括接收和处理由外部和内部传感器部件所检测到的信号所必需的电子部件，诸如处理器22(图1)。在另一个实施方式中，TLS传感器50可以包括处理ECG信号所必需的电子部件。
如已经讨论的那样，显示器30被用于在导管放置过程期间向临床医生显示信息。显示器30的内容根据导管放置系统处于的模式(US、TLS或ECG)而改变。该三种模式中的任何一种可以被临床医生立即唤起到显示器30中，并且在某些情况下，来自多个模式(诸如TLS和ECG)的信息可以被同步地显示。在一个实施方式中，如前文那样，该系统所处的模式可以被包括在手持式探测器40上的控制按钮所控制，由此消除临床医生伸出到无菌区以外(诸如接触控制台20的按钮界面32)来改变模式的需要。因此，在该实施方式中，探测器40被用于同样控制系统10的一些或全部ECG相关功能。需要注意的是，按钮界面32或其它输入配置还可以被用于控制系统功能。并且，除了视觉显示器30，该系统也可以采用诸如哔哔声、音调等等的听觉信息来在导管放置期间协助临床医生。
需要注意的是，关于系统10的更多细节可见于2014年9月30日授权的、名称为“关于导管的血管内放置的仪器和显示方法(Apparatus and Display Methods Relating to Intravascular Placement ofa Catheter)”的美国专利No.8,848,382，该专利通过引用以其全部并入本文。
图3描绘了一位患者的心电图描记的ECG复合波1176的各个细节，包括等电位线1176A、P-波1176P、Q-波1176Q、R-波1176R和S-波1176S以及T-波1176T。图4描绘了邻近的ECG复合波1176之间的进一步细节和关系，包括通常用于确定患者心率的、连续的ECG复合波之间的RR区间1180。这些波和区间在该实施方式中被系统10用于确定导管72或其它医疗装置距窦房结或患者血管内的其它期望位置的接近度，如本文所描述的那样。
图5描绘了系统10和用于将导管导向至期望的血管内位置的方法1200的概况。如图所示，方法1200利用从外部放置在患者70的皮肤上的外部电极136(本文也称为外部ECG传感器部件)所获得的外部ECG数据1210，如图2所示，但是电极的具体位置可以变化。如所提到的，外部电极136在该实施方式中以右臂/左腿“导联II”布置而被放置。
方法1200进一步利用从如上所述的内部ECG传感器部件所获得的内部的、血管内ECG数据1212，该内部ECG传感器部件在该实施方式中以探针130的ECG传感器组件来实现。在一个实施方式中，外部和血管内ECG数据1210、1212被位于TLS传感器50(图2)中的处理部件所接收并调整(conditioned)，但是诸如系统控制台20的处理器22的其它的系统部件也可以包括这一功能。
简要地并且与一个实施方式一致地，外部和血管内ECG数据1210、1212被输入P-波算法(algorithm)1216以便确定探针远侧尖端距窦房结或患者70(图2)体内的其它期望位置的血管内接近度。P-波算法1216在一个实施方式中由包括在TLS传感器50中的处理器、或者在另一实施方式中由控制台20的处理器22或者由其它合适的处理器所执行。
由P-波算法1216所产生的输出包括与血管内ECG信号的一个或多个ECG复合波的P-波的分析相关的数据，以及与导管72的探针130的远侧尖端距心脏的窦房结的接近度相关的相应的区域指定。输出被接收(通过箭头1216A)到由系统控制台20的处理器22执行的系统应用，然后该系统应用可以输出(通过箭头1218A)用于在系统显示器1220(诸如系统10的显示器30(图1、2))上描绘的与探针远侧尖端方位相关的图形信息。由临床医生对与探针远侧尖端(在该实施方式中，其与导管72的远侧尖端具有共同终端)在血管内方位相关的信息进行显示器30的观察，该观察帮助临床医生将导管远侧尖端放置在期望位置。
图6进一步描绘了关于根据该实施方式的用于导向导管的方法1200(图5)的各个细节。如图所示，方法1200包括利用外部ECG数据1210的外部ECG过程1222以及利用血管内ECG数据1212的血管内ECG过程1224，并伴有多个中间动作。另外，在一个实施方式中，方法1200由合适的处理器(诸如布置在系统控制台20中的处理器22或布置在TLS传感器50中的处理器)利用由系统部件检测到的外部和血管内ECG信号数据来执行，如上所述。
图6的顶部示出外部ECG信号数据1210被TLS传感器50所接收，该外部ECG信号数据1210包括由外部传感器部件(即，放置于皮肤的外部电极136)检测到的外部ECG信号的ECG复合波。同样地，血管内ECG信号数据1212也被TLS传感器50所接收，该血管内ECG信号数据1212包括由血管内传感器部件(即，探针70的探针ECG传感器组件)检测到的血管内ECG信号的ECG复合波。这些数据被用于如下所述的方法1200中。
在该实施方式中，首先进行利用外部ECG数据1210的外部ECG过程1222。需要注意的是，如本文将要描述的其它过程一样，过程1222可以由包括在系统10中的或与系统10可操作地联合的合适的处理器来进行。如已经提到的，这样的处理器可以包括TLS传感器50的处理器、系统控制台20的处理器22等等。
外部ECG过程1222包括阶段1230，其中，当前的ECG复合波(诸如ECG复合波1176(图3))的QRS复合波在外部ECG信号数据1210的ECG信号中被识别出。具体地，阶段1230包括确定外部ECG信号数据1210中的QRS复合波出现的位置及时间点，其在本文中也称为外部ECG信号数据1210内的QRS复合波的时间戳。类似的时间戳可以出现在随后阶段的ECG复合波的其它被识别出的方面。在一个实施方式中，16阶有限脉冲响应(“FIR”)滤波器被用于在阶段1230中识别两个连续的QRS复合波(波形)。其它方式也可以被用于识别这种和其它波形成分。
需要注意的是，在该实施方式中，外部ECG信号数据1210和血管内ECG信号数据1212为时间同步的，从而使得QRS复合波的出现或在外部ECG信号数据1210中检测到的ECG复合波的其它方面与在血管内ECG信号数据1212中检测到的ECG复合波的相同方面在时间上相一致。因此，在外部ECG信号数据1210中的ECG复合波所识别出的方面可以被用于找到在血管内ECG信号数据1212中的ECG复合波的相应的方面。
在阶段1232，在外部ECG信号数据1210中的两个连续的ECG复合波之间的R-R区间的时间间隔(诸如图4所示的R-R区间1180)被确定。除了别的之外，该时间间隔可以被用于确定患者心率。
在阶段1234，根据分析，T-波(诸如图3的T-波1176T)从外部ECG信号数据1210的当前的ECG复合波中被识别出。最后，在阶段1236，P-波(诸如图3的P-波1176P)从外部ECG数据1210的当前ECG复合波中被识别出。随着这样的识别，被识别的P-波的起始(开始)、停止(结束)和最大振幅的时间在该实施方式中的阶段1236被表现出来。
需要注意的是，用于执行阶段1230到1236的一个实施方式的算法已经被Monebo Technologies,Inc.(1800 Barton Creek Blvd.,Austin,TX 78735)开发为目标库或软件库。在一个实施方式中，该软件库可以通过作为可调用功能的应用程序接口(“API”)被访问。该软件库可以通过系统应用1218(图5)被访问。还要注意的是，在一个实施方式中，外部ECG信号数据1210的多个ECG复合波可以在进行外部ECG过程1222的上述阶段中被分析。
在阶段1240，做出决定以确定P-波在阶段1236中已被识别出来。如果没有，方法1200进入阶段1242，其中，关于在1230阶段所识别出的QRS位置的数据被传递到阶段1244的新过程。实际上，在阶段1244，P-波被再次识别，但是它是使用来自阶段1230的外部ECG信号数据1210的识别出的QRS复合波的时间戳位置，在血管内ECG信号数据1212中被识别出的。还应注意的是，因为外部和血管内ECG数据1210、1212两者为患者的心脏窦房结电活动的量度，尽管通过不同的仪器(即，用于外部ECG信号数据的外部电极136，和用于血管内ECG信号数据的探针130的探针传感器组件)来检测，它们仍然是时间同步的。因此，对来自外部ECG信号数据1210的ECG复合波的QRS复合波的识别与血管内ECG信号数据1212中相应的ECG复合波的QRS复合波或其它成分在时间/位置上相对应。
在阶段1246，确定血管内P-波(从血管内ECG信号数据1212中识别出的)是否已经在阶段1244被成功地识别出。如果答案是“否”，该过程在阶段1248向系统10发送“无报告”信号。如果在阶段1246对于血管内P-波的成功识别的答案是“是”，在阶段1250血管内P-波的时间戳位置被发送到血管内ECG过程1224。可替换地，如图6中所看到的，如果在阶段1240对于外部P-波的成功识别的答案是“是”，则阶段1242、1244和1246被跳过，并且带有时间戳的外部P-波(从外部ECG信号数据1210中识别出的)在阶段1250被发送到血管内ECG过程1224。在一个实施方式中，发送关于P-波的各个方面的时间戳数据，包括P-波开始、P-波峰(或最大振幅)和P-波停止的时间。
一经从阶段1250收到P-波位置(通过在阶段1236的外部ECG信号数据1210中或在阶段1244的血管内ECG信号数据1212中对其的识别)，血管内ECG过程1224在阶段1260通过对由内部ECG传感器检测到的P-波进行频率分析而开始。在该实施方式中并且同样地被处理器22(图1)或其它合适的处理部件所执行，阶段1260包括在频域中分析P-波从而确定其是否达到或超出预先确定的阈值。在一个实施方式中，P-波的频率可以被认为是P-波在时域中的斜率(inclined slope)。
在阶段1264，还在时域中进行P-波的振幅分析，从而确定其是否达到或超出预先确定的阈值。在该实施方式中，P-波在当它具有以下的阈值和频率范围时被确定为处在最大值，阈值为：在大约20Hz或高于20Hz时具有大约250微伏到大约1500微伏的振幅；以及频率(斜率)范围在：当P-波振幅在大约250微伏时具有超过大约10微伏每毫秒的频率到当P-波振幅在大约1500微伏时具有超过60微伏每毫秒的频率。当然，可以根据应用、期望的灵敏度、预期的目标位置等等在其它实施方式中使用其它的范围和数值。
在阶段1262，进行分析以确定血管内ECG信号数据1212中的噪声是否超出可接受的水平，从而使得可信赖的P-波测定是不可能的。具体地，过程1224在阶段1262报告与遇到的噪声水平相关的数值。在该实施方式中，噪声阈值包括：出现在ECG复合波的QRS复合波的停止或结束与连续的ECG复合波的P-波的起始或开始之间的高频(即，大于大约20Hz)噪声的最大水平小于大约35微伏，并且高频噪声的该最大水平与当前的ECG复合波中P-波的该高频成分的最大振幅的比值小于大约50％。过程1224在确定可接受的噪声阈值水平中可以采用其它的噪声值。
在阶段1266，确定ECG复合波中升高的、或最大的P-波(诸如，见于图7的ECG复合波1176中的1176P)是否已被识别出。这通过确定以上所讨论的P-波频率、振幅和噪音阈值(分别在阶段1260、1264和1262被确定)中的每个是否都被达到来完成。如果一个或多个没有达到，该过程在阶段1248向系统10发送“无报告”信号。
如果阶段1260、1262和1264的以上阈值中的每一个均已达到，阶段1266报告“是”并且阶段1268被执行，其中，进行P-波的偏移分析。图8示出ECG复合波1176的P-波部分，其包括偏移部分1278，或者在上升以形成曲折部分1276—上升到P-波的等电位线以上的P-波的部分—之前下降至等电位线1176A以下的负P-波成分。阶段1268分析P-波中这样的偏移。在该实施方式中，阶段1268通过将P-波的偏移部分1278的振幅除以P-波的曲折部分1276而得到偏移百分比来进行。偏移百分比的数值使得系统10能够确定血管内ECG传感器(作为在探针远侧尖端的探针130的探针ECG传感器组件来实施)和由此的导管远侧尖端距窦房结的接近度。
在该实施方式中，大约0％的偏移值指示基本上没有P-波的偏移并且探针远侧尖端位于或靠近SVC 1352的近底部1/3部分1354处，该SVC 1352靠近患者脉管系统的心脏1350，该位置被过程1224称为区域1，如图12所示。大于大约0％但小于或等于大约10％的偏移值指示P-波最低限度地偏移，并且探针远侧尖端已通过但靠近SVC1352的近底部1/3部分1354，该位置被过程1224称为区域2。大于大约10％的偏移值指示P-波显著地偏移，并且探针远侧尖端远远(well)超过SVC 1352的近底部1/3部分1354，该位置被算法称为区域3。需要注意的是，图12说明过程1224可以根据它对检测到的P-波特征的分析来界定并报告附加的区域。其实，图12示出可以界定诸如从-2延伸到+4范围内的多个区域，该多个区域等间隔地位于距SVC1352的近底部1/3部分1354不同距离处。当然，其它的区域和间隔也可以作为方法1200的一部分被界定。
由过程1224所指定的区域在阶段1270被报告给系统10的系统应用1218。在一个实施方式中，系统应用1218包括作为被处理器22(图1)或系统10的其它合适的部件执行的控制固件或软件应用。注意，在一个实施方式中，相同的处理器(诸如系统控制台20(图1)的处理器22)可以被用于执行方法1200和系统应用1218两者。以上描述的指示导管远侧端到患者心脏1350(图12)的接近度的三个区域可以在阶段1270被报告给系统应用1218。在另一实施方式中，附加的区域也可以被界定并报告。然后系统应用1218可以使用这些区域的报告来向系统10的用户传递相关的信息，从而协助用户将导管放置在血管内部的期望位置，如以下进一步描述的那样。
以上描述的方法1200在该实施方式中被迭代地执行，以便评价如被系统10检测到的患者的连续的ECG复合波。在其它实施方式中，非迭代运算是可以的。一旦根据由方法1200进行的P-波分析的足够数量的区域报告(即，在该区域中探针远侧尖端相对于患者心脏而被定位的该区域的报告)被系统10(通过阶段1270和/或1248)的系统应用1218所接收，显示器30(图1、2)可以被更新以指示所报告的区域(如果有的话)并且协助临床医生确定导管的远侧尖端或其它合适的医疗装置何时到达期望的血管内位置。
根据以上内容，图10A-10C示出由图6的方法1200提供给系统应用1218的、在系统10(图1、2)的显示器30上的区域报告描绘的各种实例。具体地，图10A-10C示出用以在患者的血管内部导向和放置导管的在使用系统10期间显示器30的各种描绘或屏幕截图1320。如图10A所示，显示了如由外部ECG信号传感器部件所检测到的外部ECG描记线1322，在该实施方式中，该外部ECG信号传感器部件包括外部电极136，如上进一步描述的那样。如由血管内ECG信号传感器部件所检测到的血管内ECG描记线1324也被描绘，在该实施方式中，该血管内ECG信号传感器包括探针130的探针ECG传感器组件。
还示出了传感器图像1326，其代表传感器50(图1、2)和它对探针远侧尖端的检测。探针方位图标1328被示出叠加到传感器图像1326上从而通过TLS模式中的磁追踪、刚刚描述的ECG模式中的ECG追踪、或二者的组合来指示探针远侧尖端的方位。需要注意的是，图10A中的图标1328包括靶心构造，其指示系统在ECG追踪模式期间还没有检测到探针远侧尖端到达接近SVC 1352的近底部1/3部分1354的区域1(图12)。
在一个实施方式中，图10B示出伴有传感器图像1326尺寸增大的屏幕截图1320，其为可以被临床医生选择的或由系统10自动进行的选项。需要注意的是，探针方位图标1328已变为菱形，其可以被涂成绿色，指示系统10已确定探针远侧尖端位于区域1或2(图12)之内，如由过程1224(图6)报告给该系统的那样。
在图10C中并且根据一个实施方式，为了方便临床医生，在屏幕截图1320的外部和内部ECG描记线1322、1324中示出的ECG复合波的P-波部分被诸如通过颜色来突出显示。图10C示出如果探针远侧尖端被推进超过SVC 1352的近底部1/3部分1354，方法1200的过程1224将报告区域3。这反过来引起探针方位图标1328由绿色菱形变为红色八边形，指示探针130和导管72的进一步推进应当停止。当然，系统10可以采用用于探针方位图标的其它的颜色、形状、设计和构造。其实，可以采用的方位图标的进一步实例存在于2014年3月7日提交的、并且名称为“用于留置医疗装置的导向的图标表示(Iconic Representations for Guidance of an Indwelling MedicalDevice)”的美国专利申请公开文本No.2014/0188133中，该申请通过引用以其全部并入本文。
图9示出区域报告决策树1280，其在该实施方式中由系统应用1218用于确定何时批准改变/更新显示器30从而准确地反映探针远侧尖端和由此的导管远侧尖端的方位。在方法1200(图6)的执行期间，当探针130和导管72在患者血管内部被推进，在无区域已经由过程1224报告给系统应用1218时，显示器30将把探针方位图标1328描绘为着色成黄色的靶心，如图10中在传感器图像1326上所见的。这个情况对应于标记为“Y1”以指示黄色图标颜色的区块1282。需要注意的是，在该实施方式中，在该方法的执行和系统10的运行期间，方法1200将迭代地向系统应用1218报告区域(图6中的阶段1270)或无区域(阶段1248)。
当过程1224向系统应用1218(图6)报告区域1或2时，发生从Y1区块1282到标记为“G1”以指示初始的绿色状态的区块1284的前进。当过程1224迭代地报告第二个连续的区域1或2时，做出从G1区块1284到标记为“G2”以指示绿色状态的区块1286的前进。这对应于探针方位图标1328正在由图10A的黄色靶心图标变为如图10B所见的绿色菱形图标。
如果过程1224然后向系统应用1218报告区域3或更大的区域，发生从G2区块1286到标记为“r1”以指示初始的红色状态的区块1288的前进。如果过程1224迭代地报告第二个连续的区域3或更大的区域，做出从R1区块1288到标记为“R2”以指示红色状态的区块1290的前进。这对应于探针方位图标1328正在由图10B的绿色菱形变为如图10C所见的红色八边形图标。
如果过程1224然后向系统应用1218报告区域1或2，做出从R2区块1290回到G1区块1284的前进从而如以上所描述地进行。这—和从R1区块1288或Y1区块1282到G1区块1284的类似的推进一样—由箭头1294来标示。相应地，从区块1282、1284或1286到R1区块1288的前进由箭头1296来标示。
在区块1282、1284、1286、1288和1290的任何一个上，缺少来自过程1224的任何报告持续少于三秒的时间则引起系统应用1218保持在相同的指定区块上。这由邻近区块1282、1284、1286、1288和1290中的每一个的环形箭头1292来标示。
在区块1282、1284、1286、1288和1290的任何一个上，缺少来自过程1224的任何报告持续等于或多于三秒的时间则引起系统应用1218返回到Y1区块1282，伴随探针方位图标1328的相应的改变。这由从区块1284、1286、1288和1290指向Y1区块1282的虚线箭头1302来标示。
在G2区块1286和R2区块1290上，相同区域的来自过程1224的持续的报告引起系统应用1218保持在相同的指定区块上。这分别由用于G2区块1286和R2区块1290的环形箭头1298和1300来标示。
图13示出区域报告决策树1400，其在一个实施方式中由系统应用1218用于确定何时批准改变/更新显示器30从而在导管插入和布置期间准确地反映探针远侧尖端和由此的导管远侧尖端的方位。具体地，方法1400在一个实施方式中由系统应用1218执行，基于过程1224的P-波输出1216A的区域报告1248、1270来决定如何以及何时更新显示器30上的描绘，包括探针方位图标1328(参见图10A-10C)。
方法1400在阶段1402通过查询区域报告数据(也被称为“数据集”)而开始，该区域报告数据由过程1224通过P-波输出1216A提供给系统应用1218。该区域报告数据中的每个区域报告包括无区域指示或三个区域指示中的一个：低的、高的和理想的，如以下进一步描述的那样。在阶段1404，确定查询计数或提供给系统应用1218的区域报告数量是否等于或大于50。如果不是，执行阶段1406，其在阶段1402增加另一查询或区域报告。
如果在阶段1404的查询计数在数量上结果为50或更多，执行阶段1408，其中，检查最新的区域报告以确定它是否报告了区域(对应于图6中在阶段1270的“区域报告”)或它是否报告了“无区域”(对应于图6中在阶段1248的“无区域报告”)。如果最新的区域报告是无区域，执行阶段1410，其中，无区域计数器增加一并且连续无区域的数量被计数。然后，在阶段1412，确定被计数的连续无区域的数量是否等于或大于20。如果不是，那么执行阶段1406，其在阶段1402增加另一查询或区域报告。如果在阶段1412的答案是“是”，区域计数器在阶段1414被重置为零，在阶段1432声明高态，其中，系统应用1218将在显示器30(图2)上描绘适当的指示，例如，向用户指示导管可以被进一步推进并且还没有到达期望的目的地，在这种情况下，该期望的目的地为SVC 1352的近底部1/3部分1354。在一个实施方式中，显示器30上的描绘包括如图10A中所见的探针方位图标1328的黄色靶心设计。一旦该描绘被显示，方法1400返回到阶段1406而后到阶段1402，其中，区域报告数据被重新查询。在一个实施方式中，处理先前存储的查询数据并且获取新的数据。以上所描述的过程相对于无区域报告是迭代的。
需要注意的是，在该实施方式中，阶段1404中的查询计数50对应于由系统10和方法1200(图6)所捕获的大约五秒的数据，也就是说，由TLS传感器50接收的500赫兹数据速率在区块50被处理，产生每秒10区域测定。用于存储阶段1402的数据的缓冲区按照先入先出(“FIFO”)原则运行，在接收新数据的同时逐出缓冲区中最老的数值。
如果，在阶段1408最新的区域报告报告了一个区域，则执行阶段1416，其中，无区域计数器被重置为零并且控制前进到阶段1418。在阶段1418，从最新的区域报告开始分析数据，并且在打赌(stake)阶段1420，确定是否至少有五个区域报告呈现在来自阶段1402的查询到的区域报告数据中(该至少五个区域报告不需要在数据中是连续的)。如果不是，该方法返回到阶段1406，其中，另一查询被增加到阶段1402并且该方法从那里继续进行。
如果在阶段1420的答案是“是”，则执行阶段1422，其中，分析该至少五个区域报告并且在阶段1424，确定是否该区域报告中的四个或更多个为“低的”区域报告，指示探针130的远侧尖端已通过SVC1352的近底部1/3部分1354(如在图12的区域+3、+4中)。如果是，在阶段1426声明低态，其中系统应用1218将在显示器30(图2)上描绘适当的指示，例如，向用户指示导管已被推进的太远。在一个实施方式中，显示器30上的描绘包括如图10C中所见的探针方位图标1328的红色八边形设计。一旦该描绘被显示，方法1400返回到阶段1406而后到阶段1402，其中，区域报告数据被重新查询。在一个实施方式中，处理先前存储的查询数据并且获取新的数据。
如果在阶段1424的答案是“否”，则执行阶段1428，其中，分析该至少五个区域报告，并且在阶段1430确定是否该区域报告中的三个或更多个为“高的”区域报告，指示探针130的远侧尖端还没有到达接近SVC 1352的近底部1/3部分1354(如在图12的区域-2、-1或0中)。如果是，在阶段1432声明高态，其中系统应用1218将在显示器30(图2)上描绘适当的指示，例如，向用户指示导管可以被进一步推进。在一个实施方式中，显示器30上的描绘包括如图10A中所见的探针方位图标1328的黄色靶心形设计。一旦该描绘被显示，方法1400返回到阶段1406而后到阶段1402，其中，区域报告数据被重新查询。在一个实施方式中，处理先前存储的查询数据并且获取新的数据。
如果在阶段1430的答案是“否”，则执行阶段1434，其中，分析该至少五个区域报告并且在阶段1436，确定是否该区域报告中的四个或更多个为“理想的”区域报告，指示探针130的远侧尖端已到达接近SVC 1352的近底部1/3部分1354(如在图12的区域+1或+2中)。如果是，在阶段1438声明理想态，其中系统应用1218将在显示器30(图2)上描绘适当的指示，例如，向用户指示根据该实施方式，导管已到达它的预期目的地。在一个实施方式中，显示器30上的描绘包括如图10B中所见的探针方位图标1328的绿色菱形设计。一旦该描绘被显示，方法1400返回到阶段1406而后到阶段1402，其中，区域报告数据被重新查询。在一个实施方式中，处理先前存储的查询数据并且获取新的数据。
如果在阶段1436的答案是“否”，则执行阶段1440，其中，分析该至少五个当前的区域报告并且在三个阶段1440、1442和1444中的一个或多个做出决定。在阶段1440，如果基于方法1400的即时在先迭代的先前的区域测定结果为理想态并且该五个当前的区域报告中的三个是低区域报告，那么在阶段1426声明低态，如以上已经进一步描述的那样执行该阶段。
如果在阶段1440的答案是“否”，则执行阶段1442，其中，如果基于方法1400的即时在先迭代的先前的区域测定结果为理想态并且该五个当前的区域报告中的两个或多个是理想区域报告，那么在阶段1438声明理想态，如以上已经进一步描述的那样执行该阶段。
如果在阶段1442的答案是“否”，则执行阶段1444，其中，如果基于方法1400的即时在先迭代的先前的区域测定结果为低态并且该五个当前的区域报告中的两个或更多个是低区域报告，那么在阶段1426声明低态，如以上已经进一步描述的那样执行该阶段。
如果在阶段1444的答案是“否”，在阶段1432声明高态，如以上已经进一步描述的那样执行该阶段。一旦该描绘显示随后的阶段1426、1432或1438，方法1400返回到阶段1406而后到阶段1402，其中，区域报告数据被重新查询。在一个实施方式中，处理先前存储的查询数据并且获取新的数据。
需要注意的是，在使用系统10进行医疗装置放置过程期间，该方法1400迭代地运行。需要注意的是，如可以被本领域技术人员领会的，用于评价区域报告的具体的阈值数字可以不同于本文所描述。而且，在一个实施方式中，可以采用多于三个的区域报告。
需要注意的是，还可以采用用于根据由方法1200所报告的区域信息来更新显示器30的其它的模式，包括不同的图标或符号或输出模式、不同颜色的图标等等。更通常地，系统应用1218可以利用其它的报告决策树来控制显示器30或其它输出模式上来自方法1200的区域信息的描绘。在另一个实施方式中，方法1200可以报告除了区域以外的其它参数。
需要注意的是，过程1224的阶段1260-1264可以同步地或者以不同于显示在图6中的顺序来进行。方法1200的算法也可以评价其他参数，包括患者心率、等电位/基线漂移、以及检测到的QRS复合波的垂直。例如，在大约50到大约150每分钟心跳之间的患者心率阈值可以作为参数由方法1200进行评价以确保医疗装置适当的血管内放置。在另一实例中，在2.5赫兹的+/-大约300微伏的允许的基线漂移可以被用作参数。在另一个实施方式中，在大约0.08到大约0.10秒之间的持续时间内的QRS复合波长度可以被用作参数。可以采用这些和其它合适的参数。一般来说，应当注意在其它实施方式中方法1200可以包括更多或更少的阶段，从而协助追踪和定位导管或其它合适的医疗装置。
图11示出根据另一实施方式的方法1200，其中，仅采用血管内ECG传感器部件，而不是外部和血管内ECG传感器部件两者均用于确定P-波最大值。如此，没有诸如外部电极136(图2)的外部电极被布置在患者的皮肤上。相反地，通过使用基线ECG信号来执行阶段1230、1232、1234、1236和1240。使用由探针130的探针传感器组件(即，血管内ECG传感器部件)检测到的ECG信号来获取基线ECG信号。具体地，当探针远侧尖端在插入位点73(图2)与探针和导管72被插入其中的臂部上的大约肩部区域(即，图2示出的实例中的右臂)之间被布置在血管中时，从探针130的探针ECG传感器组件获取基线ECG信号。需要注意的是，在另一实施方式中，插入位点可以在患者的另一肢体上，诸如腿，在这种情况下，当探针远侧尖端被布置在插入位点和该肢体(腿)与患者躯干的连接点之间时，从探针ECG传感器组件获取基线ECG信号。
如以上刚刚描述的(与布置在患者臂部上的插入位点一起描述的)在探针传感器组件被布置时对ECG信号的检测近似于来自基于艾因托文氏三角的“导联II”配置的一对外部的放置于皮肤的电极的ECG信号检测。如此，这样检测到的ECG信号会基本上保持不变，并且可以用作相对于血管内ECG信号的基线参考ECG信号，该血管内ECG信号是在探针130被推进超过臂部的大致肩部区域(探针和导管被插入到其中)时由探针传感器组件检测到的。这样的推进会使得探针传感器组件能够在探针靠近患者心脏1350(图12)的窦房结时检测变化的P-波。因此，在该实施方式中，阶段1230、1232、1234、1236和1240近似于以上结合图6的描述所进一步描述的那样被执行，在执行的同时使用由探针传感器组件检测到的基线ECG信号(血管内ECG信号数据1212的一部分)，探针传感器组件在导管72和所包括的探针130初始插入到血管中但是在推进超过臂部的肩部区域(导管和探针被插入到其中)之前检测该基线ECG信号。
需要注意的是，如结合图11所描述的那样，二者均来自由血管内ECG传感器部件(即，探针130的探针传感器组件)的检测的基线和血管内ECG信号的使用及分析在一个实施方式中使得临床医生能够观察状况，该状况可能仅在血管内ECG信号中是明显的，并且在通过外部ECG传感器部件(诸如图2的外部电极136)检测到的外部ECG信号中是不明显的。这样的状况的一个实例包括例如，心房内传导阻滞。
本文所公开的实施方式可以包括包含计算机硬件的特殊用途或一般用途的计算机，如以下更详细地讨论。在本公开内容的范围内的实施方式还包括用于携带或具有计算机可执行指令或存储于其上的数据结构的计算机可读介质。这样的计算机可读介质可以是能够被一般用途或特殊用途的计算机访问的任何可用的介质。举例来说，并且是非限制性的，计算机可读介质可以包含物理的(或可记录型)计算机可读存储介质，诸如RAM、ROM、EEPROM、CD-ROM或其它光盘存储器、固态存储器、磁盘存储器或其它磁存储设备、或者可以用于以计算机可执行指令或数据结构的形式存储期望的程序代码工具并且能够被一般用途或特殊用途的计算机访问的任何其它的媒介。
在这个说明书中和在以下的权利要求书中，“网络”被定义为使得电子数据能够在计算机系统和/或模块之间传输的一个或多个数据链路。当信息通过网络或另一通信连接(硬连线的、无线的、或硬连线或无线的组合中的任何一者)被传递或提供给计算机时，该计算机适当地将该连接视为计算机可读媒介。因此，举例来说，并且是非限制性的，计算机可读介质可以还包含能够用于以计算机可执行指令或数据结构的形式携带或存储期望的程序代码工具并且能够被一般用途或特殊用途的计算机访问的网络或数据链路。
计算机可执行指令包括，例如，引起一般用途计算机、特殊用途计算机或特殊用途处理装置执行特定的功能或功能组的指令和数据。计算机可执行指令可以是，例如，诸如汇编语言或甚至源代码的二进制的、中间格式指令。尽管已经用明确的语言将主体描述到结构特征和/或方法行为，应当理解的是，附加的权利要求书中所限定的主题不一定被限定到以上所描述的特征或行为。更确切地说，所描述的特征和行为作为实施权利要求的实例形式被公开。
本领域技术人员将领会到，本文的实施方式可以使用多种类型的计算机系统配置(包括个人计算机、台式计算机、便携式计算机、信息处理器、手持装置、多处理器系统、基于微处理器的或可编程的消费电子产品、网络PCs、小型计算机、大型计算机、移动电话、PDAs、寻呼机等等)在网络计算环境中实施。实施方式也可以在分布式系统环境中实施，在该环境中通过网络连接的(通过硬连线的数据链路、无线数据链路、或硬连线和无线数据链路的组合中的任何一者)本地和远程计算机系统均执行任务。在分布式系统环境中，程序模块可以位于本地和远程记忆存储装置的两者中。
本发明的实施方式可以在不脱离本公开内容的精神的情况下在其它具体形式中被具体化。所描述的实施方式在各个方面均被认为是说明性的，而非限制性的。实施方式的范围因此被附加的权利要求书而不是被前述的说明书所指示。在权利要求书的等同的含义和范围之内的改变均包含在它们的范围之内。

Claims (29)

1.一种用于将医疗装置导向至患者的血管内部的期望位置的方法，所述方法包括：
检测所述患者的血管内ECG信号；
识别所述血管内ECG信号的波形的P-波，所述P-波根据所述医疗装置到所述期望位置的接近度而变化；
确定被识别的所述P-波是否是升高的；
在被识别的所述P-波是升高的时确定被识别的所述P-波的偏移值；以及
至少部分地根据被确定的升高的所述P-波的所述偏移值来报告与所述医疗装置在所述患者的所述血管内部的位置相关的信息。
2.根据权利要求1所述的用于导向的方法，进一步包括：
检测所述患者的外部ECG信号；
识别所述外部ECG信号的波形的外部P-波；以及
使用被识别的所述外部P-波来识别所述血管内ECG信号的所述P-波。
3.根据权利要求2所述的用于导向的方法，其特征在于，识别所述外部P-波进一步包括：
识别所述外部ECG信号的所述波形的QRS复合波；
识别所述外部ECG信号的所述波形的T-波；以及
确定所述外部ECG信号的连续波形之间的RR区间。
4.根据权利要求3所述的用于导向的方法，其特征在于，所述外部ECG信号由放置在所述患者的皮肤上的一对外部电极来检测。
5.根据权利要求1所述的用于导向的方法，其特征在于，所述血管内ECG信号由传感器部件检测，所述传感器部件被包含于被可移除地接纳在所述医疗装置内的探针。
6.根据权利要求1所述的用于导向的方法，其特征在于，识别P-波、确定被识别的所述P-波是否是升高的以及确定所述偏移值由与所述医疗装置可操作地连接的系统的处理器执行。
7.根据权利要求6所述的用于导向的方法，其特征在于，识别P-波、确定被识别的所述P-波是否是升高的以及确定所述偏移值由所述处理器迭代地执行。
8.根据权利要求1所述的用于导向的方法，其特征在于，所述医疗装置包括导管，并且其中，所述期望位置接近所述患者的心脏的上腔大静脉的较低部分。
9.根据权利要求1所述的用于导向的方法，其特征在于，报告与所述医疗装置的所述位置相关的信息包括报告多个区域中的一个，每个区域与所述医疗装置到所述患者心脏的信号发射结点的接近度相关。
10.根据权利要求1所述的用于导向的方法，其特征在于，报告与所述医疗装置的位置相关的信息包括将所述信息输出到音频装置和显示装置中的至少一个。
11.根据权利要求1所述的用于导向的方法，其特征在于，报告与所述医疗装置的位置相关的信息包括将图形信息输出到用于所述医疗装置的放置系统的显示装置。
12.根据权利要求11所述的用于导向的方法，其特征在于，所述图形信息包括对应于所述医疗装置到所述患者心脏的信号发射结点的接近度的多个图标。
13.一种用于将医疗装置导向至患者的血管内部的期望位置的方法，所述方法包括：
由所述医疗装置包含的血管内ECG传感器部件检测所述患者的心脏的信号发射部分的血管内ECG信号；以及
基于多个预先确定的阈值确定所述血管内ECG信号的波形的P-波是否是升高的，所述P-波根据所述血管内ECG传感器部件距所述心脏的所述信号发射部分的距离而变化，所述预先确定的阈值与以下中的至少一个相关：
(a)在预先确定的范围内的所述血管内ECG信号的所述P-波的振幅；
(b)在预先确定的范围内的所述血管内ECG信号的所述P-波的斜率；以及
(c)在预先确定的范围内的所述血管内ECG信号的噪声分量。
14.根据权利要求13所述的用于导向的方法，进一步包括：
确定在所述P-波是升高的时所述P-波的偏移值；以及
至少部分地根据被确定的所述P-波的所述偏移值来报告与所述医疗装置在所述患者的所述血管内部的位置相关的信息。
15.根据权利要求13所述的用于导向的方法，其特征在于，检测所述血管内ECG信号、确定所述P-波是否是升高的以及确定所述偏移值被迭代地执行。
16.一种用于将医疗装置导向至患者的血管内部的期望位置的系统，包括：
用于检测所述患者的血管内ECG信号的至少一个血管内ECG传感器；
接收所述血管内ECG信号的处理器，所述处理器：
识别所述血管内ECG信号的波形的P-波，所述P-波根据所述医疗装置到所述期望位置的接近度而变化；
确定被识别的所述P-波是否是升高的；
确定在被识别的所述P-波是升高的时被识别的所述P-波的偏移值；以及
至少部分地根据被确定的升高的所述P-波的所述偏移值来报告与所述医疗装置在所述患者的所述血管内部的位置相关的信息；和
报告与所述医疗装置的所述位置相关的所述信息的输出装置。
17.根据权利要求16所述的用于导向的系统，其特征在于，所述处理器确定被识别的所述P-波是否是升高的进一步包括以下中的至少一者：
确定被识别的所述P-波的频率和振幅中的至少一者在预先确定的范围内是否下降；
确定所述血管内ECG信号的噪声分量在预先确定的范围内是否下降。
18.根据权利要求16所述的用于导向的系统，其特征在于，所述输出装置包括所述系统的显示器。
19.根据权利要求18所述的用于导向的系统，其特征在于，所述处理器执行决策树，所述决策树确定何时报告与所述医疗装置的所述位置相关的所述信息。
20.根据权利要求19所述的系统，其特征在于，所述医疗装置放置系统进一步包括磁追踪模式和超声成像模式中的至少一个。
21.在包括用于插入到患者的血管中的医疗装置、外部ECG传感器部件、和所述医疗装置包含的血管内ECG传感器部件的导向系统中，一种用于导向所述医疗装置的方法，所述方法包括：
(a)在所述医疗装置插入所述血管之后，从来自所述血管内ECG传感器部件的血管内ECG信号的波形中识别P-波；
(b)确定被识别的所述P-波的频率和振幅中的至少一者在预先确定的范围内是否下降；
(c)确定所述血管内ECG信号的噪声分量在预先确定的范围内是否下降；以及
(d)基于阶段(b)和(c)的所述确定来确定被识别的所述P-波是否处于升高状态。
22.根据权利要求21所述的用于导向的方法，进一步包括：
(e)确定在被识别的所述P-波处于阶段(d)确定的升高状态时被识别的所述P-波的偏移值。
23.根据权利要求22所述的用于导向的方法，进一步包括：
(f)基于阶段(e)确定的所述偏移值来描绘所述医疗装置的方位。
24.根据权利要求23所述的用于导向的方法，其特征在于，所述系统的处理器执行决策树，所述决策树确定描绘所述医疗装置的所述方位的一个方面。
25.根据权利要求24所述的用于导向的方法，其特征在于，所述决策树迭代地查询多个区域报告的数据集，直到获取至少50个区域报告。
26.根据权利要求24所述的用于导向的方法，其特征在于，在来自所述数据集的五个区域报告中的至少三个相同时，所述处理器描绘所述医疗装置的所述方位。
27.根据权利要求21所述的用于导向的方法，进一步包括：
识别来自所述外部ECG传感器部件的外部ECG信号的波形的外部P-波；以及
使用被识别的所述外部P-波在阶段(a)识别所述血管内ECG信号的所述P-波。
28.一种用于将导管导向至患者的血管内部的期望位置的方法，所述方法包括：
通过所述患者的肢体上的插入位点将所述导管的远侧部分插入所述血管；
通过所述导管包含的ECG传感器检测所述患者的基线ECG信号，在所述导管的所述远侧部分被布置在所述插入位点和所述肢体与所述患者躯干的连接点之间时，所述基线ECG信号被检测；
尝试识别所述基线ECG信号的波形的基线P-波；
识别血管内ECG信号的波形的血管内P-波，在所述导管的所述远侧部分被布置在所述肢体的所述连接点的远侧位置时，所述血管内ECG信号被检测，所述血管内P-波根据所述导管到所述期望位置的接近度而变化；
确定被识别的所述血管内P-波是否是升高的；
确定在被识别的所述血管内P-波是升高的时被识别的所述血管内P-波的偏移值；以及
至少部分地根据被确定的升高的被识别的所述血管内P-波的所述偏移值来报告与所述导管在所述患者的所述血管内部的位置相关的信息。
29.根据权利要求28所述的用于导向的方法，其特征在于，识别所述血管内P-波通过使用与所述基线P-波的所述识别相关的信息被至少部分地执行。
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