CN103442632A - Ecg辅助导管末端放置的再确认 - Google Patents

Ecg辅助导管末端放置的再确认 Download PDF

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CN103442632A
CN103442632A CN2011800401514A CN201180040151A CN103442632A CN 103442632 A CN103442632 A CN 103442632A CN 2011800401514 A CN2011800401514 A CN 2011800401514A CN 201180040151 A CN201180040151 A CN 201180040151A CN 103442632 A CN103442632 A CN 103442632A
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ecg signal
conduit
signal profile
ecg
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K·B·鲍尔斯
J·C·比斯利
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CR Bard Inc
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Abstract

公开了在患者ECG信号的辅助下对以血管内方式放置的导管的位置进行再确认，由此辅助确定患者脉管系统中的后续导管移位。在一个实施方案中，用于再确认留置医疗设备在患者身体内的位置的方法包括首先使用患者ECG信号将医疗设备放置在患者身体内。在所述医疗设备的初始放置之后，储存与所述留置医疗设备的初始位置相关的第一ECG信号轮廓。然后，获取在所述医疗设备的初始放置之后的一时刻与所述留置医疗设备的位置相关的第二ECG信号轮廓。比较所述第一ECG信号轮廓与所述第二ECG信号轮廓，以确定所述留置医疗设备是否已发生移位。

Description

ECG辅助导管末端放置的再确认
相关申请的交叉引用：本申请要求2010年8月20日递交的、题为“用于ECG辅助导管末端放置的再确认的系统(System for Reconfirmation of ECG-Assisted Catheter TipPlacement)”的美国临时专利申请No.61/375,442的权益，该美国临时专利申请No.61/375,442通过引用被整体并入本文。
发明内容
简要概述，本发明的实施方案涉及对在患者ECG信号的辅助下已被放置的导管或其他留置设备的位置的再确认。本文描述的系统和方法使得临床医生能够确认留置导管的远侧末端是否保留为安置在与导管被初始放置时相同的位置。如果末端被发现为已移至另一位置，则可以采取一些步骤来使它回到其适合的位置。
在一个实施方案中，用于再确认留置医疗设备在患者身体内的位置的方法包括首先使用患者ECG信号将医疗设备放置在患者身体内。在所述医疗设备的初始放置完成之后，储存与所述留置医疗设备的初始位置相关的第一ECG信号轮廓。然后，获取在所述医疗设备的初始放置之后的一时刻与所述留置医疗设备的位置相关的第二ECG信号轮廓。比较所述第一ECG信号轮廓与所述第二ECG信号轮廓，以确定所述留置医疗设备是否已发生移位(displacement)。如果已发生移位，则临床医生可以采取必要的步骤来根据所需再定位(reposition)所述导管。
本发明实施方案的这些和其他特征将从下面的说明和所附的权利要求书中变得更加完整清晰，或者可以通过对由下文所阐明的本发明实施方案的实践来获悉。
附图说明
将通过参考本发明的具体的实施方案提供对本发明的更加具体的描述，所述的具体实施方案在所附的附图中被图示说明。可以理解，这些附图仅描绘本发明的典型实施方案，因而不能被认为是对本发明范围的限制。将通过使用说明书附图来以附加的特征和细节对本发明的示例性实施方案进行描述和解释，其中：
图1为根据本发明的一个示例性实施方案，描绘用于脉管系统内的导管放置的系统的各种元件的框图；
图2为患者和借助于图1的所述系统被插入患者的导管的简化视图；
图3为在根据一个实施方案的图2的导管中的导电通路配置的部分剖开视图；
图4为用于根据一个实施方案使用的卡读取器/编码器系统的立体视图；
图5为根据一个实施方案的包括RFID芯片的导管分叉部(bifurcation)的顶视图；
图6为RFID读取器/编码器的简化顶视图；以及
图7为根据一个实施方案的图2的系统的显示器的屏幕截图，示出在使用系统进行导管位置的确认期间的多个ECG波形。
具体实施方式
现在将参考附图，其中相似的结构将被提供以相似的参考编号。可以理解，附图为本发明的示例性实施方案的图解的和示意的表征，并且所述附图为非限制性的，也无须按比例绘制。
为清楚起见，将理解到的是，词语“近侧的(proximal)”是指相对地更靠近使用本文要描述的设备的临床医生的方向，而词语“远侧的(distal)”是指相对地远离临床医生的方向。例如，被放置在患者体内的导管的端被认为是所述导管的远侧端，而所述导管仍保留在体外的端为所述导管的近侧端。另外，如本文(包括权利要求书)所使用的词语“包括(including)”、“具有(has)”以及“具有(having)”，应当具有同词语“包括(comprising)”相同的意思。
本发明的实施方案一般地涉及对在患者ECG信号的辅助下已被放置的导管或其他留置设备的位置的再确认。如本文所阐述的，本文所描述的系统和方法特别地使得临床医生能够确认留置导管的远侧末端是否保留为安置在与导管被初始放置时相同的位置。如果末端被发现为已移至另一位置，则可以采取一些步骤来使它回到其适合的位置。
首先参照图1和图2，其中导管放置和监控系统(整体上以10标示)的一个实施例被示出。系统10使得下列操作能够进行，即通过超声成像的患者70的皮下血管的可视化，接着通过监控由患者的心脏的SA结发射的ECG信号的在患者脉管系统中的导管72的插入、推进和最终放置。系统10的硬件和其他部件的简化框图在图1中被示出，而图2描绘与患者70相关的系统和导管72。如所示的，系统10在一个实施方案中一般地包括容纳显示器30的控制台20、超声探测器40以及用于放置在患者70的胸部上的传感器单元50。
更详细的且如上所述的，图2示出相对患者70，在通过皮肤插入部位73将导管72放入患者脉管系统的过程中，系统10的多个部件的一般关系。图2示出导管72一般地包括留在患者外部的近侧部分74以及在放置完成后留在患者脉管系统中的远侧部分76。系统10被用来将导管72的远侧末端76A最终安置(position)在患者脉管系统中的期望位置。在一个实施方案中，对导管远侧末端76A而言，所述期望位置是临近患者的心脏，例如在上腔静脉(“SVC”)的下三分之一(1/3)部分内。当然，系统10可以被用来将所述导管远侧末端放置在其他位置。导管近侧部分74还包括分叉部74A，分叉部74A提供导管72的一个或更多个内腔与从该毂部分(hub)向近侧延伸的一个或更多个延伸腿74B之间的流体连通。每个延伸腿74B包括鲁尔连接器74C来附接到适合的医疗设备。
控制台20容纳对系统10的操作来说是必需的各种部件。包括非易失性存储器(例如EEPROM)的处理器22被包括在控制台20中，用于在系统10的操作期间控制系统的功能，从而起到控制处理器的作用。与控制台20一起，还包括数字控制器/模拟界面24，并且所述数字控制器/模拟界面24同时与处理器22和其他系统部件通信，以控制超声探测器40、传感器50以及其他系统部件之间的接口连接(interfacing)。
控制台20还包括用于与传感器50连接的端口52以及可选的部件54，包括打印机、储存介质、键盘等。在一个实施方案中所述端口52为USB端口，然而其他端口类型或端口类型的组合可以被用于这一端口和本文所描述的其他接口连接。与控制台20一起，包括有电源连接装置56，以使能与外部电源供应装置58的可操作连接。也可以采用内部电池60与外部电源供应装置一起使用，或单独使用内部电池60。与所述控制台20的数字控制器/模拟界面24一起，包括有电源管理电路59，以调节电源的使用及分配。
在本实施方案中系统10的显示器30被集成到控制台20中并且被用来在导管放置过程中，并且如将可见的，在根据下面要描述的实施方案进行导管远侧末端位置的再确认期间，向临床医生显示信息。可选地，显示器可以与控制台分离。在一个实施方案中，控制台按钮界面32和被包括在探测器40上的按钮在导管放置过程中可以被用来控制系统10的功能。因此，系统控制台20的单个显示器30可以被用来在进入患者的脉管系统时、在相对于患者的心脏的结的导管远侧末端放置的基于ECG的确认中以及如下将可见的在导管远侧末端位置的后续确认中进行超声引导。在一个实施方案中，显示器30为LCD设备。
如上所述，超声探测器40与皮下血管(例如静脉)的基于超声(“US”)的可视化结合来使用，为导管72插入脉管系统做准备。这样的可视化为(经由插入部位73)将导管引导到患者的脉管系统中提供实时超声引导并且辅助减少一般与这样的引导相关联的并发症，包括意外动脉穿刺、血肿、气胸等等。
手持探测器40包括头部，所述头部容纳压电阵列来产生超声脉冲，并且在当所述头部邻近预期的插入部位73抵靠患者的皮肤被放置时接收该超声脉冲被患者的身体反射之后的回波。探测器40还可以包括用于控制系统10的多个控制按钮来控制系统功能，由此排除临床医生要到无菌区域之外的需求，该无菌区域是在导管放置之前在患者插入部位附近建立的。
这样，在一个实施方案中，临床医生采用系统10的超声模式来确定适合的插入部位并且建立例如使用针或引导装置(introducer)然后使用导管的脉管进入。临床医生然后可以通过对包括在探测器40上的按钮进行按钮推动来以无缝的方式切换到基于ECG的导管末端导引模式(下面被描述)，而无需到无菌区域之外。以这种方式，系统10辅助临床医生朝向所预期的目的地导引导管72的远侧末端通过脉管系统。
图1示出探测器40还包括按钮和存储器控制器42，用来控制按钮和探测器的操作。在一个实施方案中，按钮和存储器控制器42可以包括非易失性存储器，例如EEPROM。按钮和存储器控制器42与控制台20的探测器接口44进行可操作的通信，探测器接口44包括用于与所述探测器压电阵列接口连接的压电输入/输出部件44A，以及用于与按钮和存储器控制器42接口连接的按钮和存储器输入/输出部件44B。
如所述的，系统10包括这样的功能，其中导管远侧末端76A相对于患者70的心脏的窦房(“SA”)结或其他电脉冲发射结的接近度判定可以被确定，由此提供增强的能力来将导管远侧末端准确放置在邻近所述结的期望位置。在本文中也被称为“ECG”或“基于ECG的末端确认”，系统10的这种模式使得来自SA结的ECG信号的检测能够进行，从而将导管远侧末端放置在患者脉管系统中的期望位置。注意的是，US和ECG模式在本系统10中被以无缝的方式进行组合，并且可以以配合的方式或以单独的方式被采用来辅助导管放置。此外，其他模式(例如基于磁元件的导管末端定位)也可以被包括在系统10中。在一个实施方案中，理解的是，如本文所描述的ECG模式可以被包括在独立式系统(stand-alone system)中而不包括US或其他模式。由此，在其中本文的实施方案被描述的环境仅被理解为示例性的环境而不认为是限制本公开。还要注意的是，其他基于ECG的导引/监控系统可以与下面进一步描述的远侧末端再确认实施方案结合使用。
图1和2示出以可移除的方式预设置在导管72的内腔中的探针130通过插入部位73被插入患者70体内。探针130包括感测部件，即邻近其远侧端的电极，来感测SA结产生的ECG信号。探针130包括从其近侧端延伸的可操作地连接到传感器50的绳缆134。简言之，探针绳缆134提供导电路径，该导电路径允许由包括在探针130的远侧部分上的ECG电极所检测的ECG信号在导管推进期间被传递至传感器50。
参考和接地ECG皮肤电极138附接到患者70的皮肤表面并且被可操作地附接到传感器50，以使得系统能够滤除与心脏的SA结的电活动无关的高电平电活动，由此使得基于ECG的末端定位确认功能能够进行。与从放置在患者皮肤上的ECG皮肤电极138接收的参考和接地信号一起，探针电极所感测的ECG信号被安置在患者胸部或系统10的其他指定部件上的传感器50接收。传感器50和/或控制台处理器22可以处理ECG信号数据以在显示器30上产生心电图波形。在传感器50处理ECG信号数据的情况下，处理器被包括在其中来执行所预期的功能。如果控制台20处理ECG信号数据，则处理器22、控制器24或者其他处理器可以在控制台中被利用来处理该数据。
由此，当导管72被推进通过患者脉管系统时，显示器30描绘由于通过探针130的电极所检测的患者心脏的电活动而产生的ECG心电图波形。更详细的，SA结的ECG电活动(包括波形的P-波部分)被探针130的电极所检测并且被传送至传感器50和控制台20。ECG电活动然后被处理，以在显示器30上描绘。放置导管的临床医生然后可以观察ECG数据(包括P-波的描绘)，以确定导管72的远侧末端76A的最优放置，例如在一个实施方案中邻近SA结。
注意的是，随着探针130的电极相对于患者心脏的SA结被移动时，ECG波形及其P-波改变。例如，ECG波形的P-波在电极靠近SA结时一般地在幅值上会增大并且将在电极从SA结收回时一般地会减小。如所述的，在一个实施方案中，控制台20包括接收和处理探针电极所检测的ECG信号所必需的电子部件，例如处理器22。在另一实施方案中，传感器50可以包括处理ECG信号所必需的电子部件。关于本文描述的导管放置系统及其使用的进一步细节可以参见2009年9月10日递交的、题为“关于导管的血管内放置的装置和显示方法(Apparatus and Display Methods Relating to Intravascular Placement of aCatheter)”的美国专利申请公开No.2010/0036227，该美国专利申请公开No.2010/0036227通过引用被整体并入本文。当然，理解的是，上面描述的基于ECG的导管放置系统仅仅是可以被用来实践本文公开的实施方案的ECG监控器的一个实施例；当然，还可以采用其他基于ECG的监控和放置系统。
注意的是，在本实施方案中，探针130的电极包括导电探针丝的远侧部分，以致ECG信号被检测并且经由探针丝被发送到绳缆134和传感器50。然而，注意的是，用来检测血管内ECG信号的电极可以以许多不同的方式被配置。这样，本文所使用的“电极”可以一般地指可以被用来检测来自患者的心脏的ECG信号的任何构件。如将可见的，除了其他可能的电极配置外，电极在其他实施方案中可以包括设置在导管的内腔中的导电溶液柱的一部分。
如上面进一步描述的，在探针电极(一个或多个)在脉管系统中被推进时对检测到的由SA结发射的ECG信号的变化的监控使得放置导管的临床医生能够确定何时导管72的远侧末端根据期望被安置在脉管系统中。再者，期望的导管远侧末端位置的一个实施例包括其在上腔静脉(“SVC”)的下三分之一(1/3)处的放置。在导管72的放置完成之后，探针130从导管72的内腔被移除并且导管为初始使用做好准备。当导管72的远侧末端76A被初始放置在患者脉管系统中的其期望位置上时检测到的ECG波形在本文中也被称为第一ECG信号轮廓(profile)。
通常期望的是在导管初始放置之后的一稍后时刻再确认导管远侧末端76A的位置，从而确保没有意外地发生远侧末端的错位或移位。这又确保经由导管递送至患者的药剂或其他溶液被递送至脉管系统的期望区域。系统10或其他适合的ECG监控系统可以被用于放置后再确认适合的导管远侧末端位置。
在一个实施方案中，这样的导管远侧末端放置的再确认可以通过这样的方式来实现，即测量经由恰当放置的电极在就位(in-place)导管的远侧末端或在就位导管的远侧末端附近检测的-ECG波形-在本文中也被称为第二ECG信号轮廓，然后比较第二ECG轮廓与当导管72被初始地放置时使用系统10所获得的第一ECG轮廓。
为在留置导管远侧末端测量ECG信号并且由此获取第二ECG轮廓，适合的导电路径必须被提供在导管72中来使得相对于导管远侧末端的ECG信号能够被检测并且被发送到系统10或其他适合的ECG监控器。在一个实施方案中，临时设置在导管中的导线被用作导电介质，其中其远侧端起到电极的作用，以检测ECG信号。导线可以被插入通过鲁尔连接器74C中的一个及其相应的延伸腿74B，然后向远侧通过导管72的内腔。获知所述就位导管72的长度，导线被推进直到其远侧端邻近导管的远侧末端76A或者与导管的远侧末端76A共端头。
延伸超过导管72的近侧端并且延伸出延伸腿74B(导线延伸通过该延伸腿74B)的导线的近侧端以与图2的探针130和绳缆134类似的方式被可操作地连接到系统10。这样的配置使得SA结发射的ECG信号(即第二ECG轮廓)能够在导线的远侧端或在导线的远侧端附近被检测并且经由导线被发送到系统10，由此通知临床医生关于导管72的远侧末端76A在其当前位置的ECG轮廓。
如所述的，如上面刚刚论述的内容进行配置的导线类似于图2中所示的探针130。事实上，在一个实施方案中用于初始导管放置的探针130在初始放置之后可以被再次使用，以通过将其插入导管72的内腔并且经由图2中所示的绳缆134将其可操作地连接到系统10来再确认导管远侧末端定位，从而使得导管远侧末端在其当前位置的第二ECG轮廓能够被获取。此外，另一适合的探针或导丝可以被用来提供上面描述的从导管远侧末端到系统的导电路径。
图3示出用于在处于留置导管远侧端76A或留置导管远侧端76A附近的电极与用于末端位置再确认的系统10之间提供导电路径的另一配置的细节。特别地，导电路径包括设置在各自延伸腿74B和导管72的内腔中从而延伸到导管72的远侧末端76A的导电溶液200。导电溶液200包括盐溶液(saline)或其他生物可相容且导电的溶液。这样配置，导电溶液200用作用于在导管72的远侧末端76A检测ECG信号的电极以及导电路径的一部分。帽202被连接到各自流体充注的延伸腿74B的鲁尔连接器74C。
除导电溶液200外，图3的实施方案的导电路径还包括导线208，该导线208通过帽202并且向远侧延伸通过各自的延伸腿74B以致其远侧端208B被浸入导电溶液。终止于近侧端208A的导线208的近侧部分从帽202延伸。鳄鱼夹210或其他适合的电气连接器被附接到导线208的近侧部分。夹210被可操作地连接到绳缆234，绳缆234以与图2中的绳缆134的连接方式类似的方式连接到系统10的传感器50，由此可操作地将设置在导管72中的导电溶液200的柱连接到系统并且使得导电溶液所检测的ECG信号能够被发送至系统。以这种方式，表征导管72的远侧末端76A在脉管系统中的位置的第二ECG信号轮廓可以被获取。除了结合图2和图3描述的那些之外，注意的是，在其他实施方案中可以采用其他导电路径配置。由此，这些导电路径解决方案应当被认为是非限制性的。
为比较在初始导管远侧末端放置时刻获取的第一ECG信号轮廓与在远侧末端位置再确认时刻测量的后续第二EGC轮廓，用于储存初始放置时刻的第一ECG信号轮廓的储存部件是必需的。在一个实施方案中，这一点通过为系统10或其他适合的ECG监控器系统提供卡读取器/编码器250来实现，卡读取器/编码器250的实施例在图4中被示出为附接到控制台20。由此，当导管72使用系统10被初始放置时，患者数据卡254可以通过将卡刷过读取器/编码器250而被系统10编码，该患者数据卡254将与初始导管放置相关的各种数据(包括初始放置时刻的第一ECG信号轮廓)编码并储存在该数据卡的磁条256上。卡254然后被交与患者或者以其他方式被保管。
随后，当期望再确认先前放置的导管72的远侧末端76A的位置(图1)时，导管以上面结合图2、图3所描述的配置中的一种或者通过另一适合的方式被可操作地连接到系统10，从而提供从导管的远侧末端76A到系统的导电路径。初始导管放置时刻编码的卡254然后被刷过系统10的读取器/编码器250，从而由此被读取。这将初始放置时刻的导管远侧末端位置的第一ECG信号轮廓提供给系统10。第一ECG信号轮廓(例如包括在初始放置时刻在导管72的远侧端76A或导管72的远侧端76A附近的电极所检测的ECG波形)可以被描绘在系统控制台20的显示器30(图1)上或者以其他方式被传递给临床医生。
然后进行新的ECG信号测量，用来产生与脉管系统中的当前导管远侧末端位置相关的第二ECG信号轮廓，所述新的ECG信号测量使用设置在导管72的远侧末端76A或导管72的远侧末端76A附近的电极以及互连该电极与系统10的适合的导电路径。与第一ECG信号轮廓相似，第二ECVG信号轮廓也可以被描绘在系统控制台20的显示器30上。两个ECG信号轮廓可以被叠置(superimposed)为ECG波形位于彼此之上并且以某些适合的方式来比较(例如，测量P-波绝对电压值)，从而确定导管72的远侧末端76A是否已经被不符合期望地移位。如果这样的话，临床医生可以采取适合的程序来以适当的方式再确认导管远侧末端76A。如果其没有被移位，则导管72可以根据预期来使用。注意的是，上面描述的过程的具体顺序在其他实施方案中可以不同。例如，在一个实施方案中，第二ECG信号轮廓的获取可以发生在将第一EGC信号轮廓输入到系统中之前。
图5示出用于使得储存和存取初始放置第一ECG信号轮廓和其他数据能够进行的另一可能的储存部件，其中RFID芯片270被嵌入在导管72自身的一部分中，例如分叉部74A(同样参见图2)。如图6所示的，包括天线280和相关联的电路282的RFID编码器/读取器274可以与系统10或其他适合的ECG监控器一起被包括，以使得与初始放置时刻导管远侧末端76A的位置相关的第一ECG信号轮廓能够被编码和储存在导管RFID芯片270上。在一个实施方案中，RFID芯片270为现场可编程芯片，包括用于芯片自身的唯一标识的只读存储器以及RFID编码器/读取器274可编程的非易失性存储器二者来储存初始放置时刻的第一ECG信号轮廓。
除第一ECG信号轮廓之外，包括患者姓名、初始放置的日期和位置、修剪之后的导管最终长度、先前动力注入的记录、肌酸酐或其他血球计数等在内的其他数据可以被储存在RFID芯片270(或者图4的卡254或其他适合的储存部件)上。在一个实施方案中，PICC的在放置完成之后保留在插入部位外部的部分的长度被储存。在另一实施方案中，门户网站信息可以被储存来将使用者引导至这样的网站，在所述网站提供有用的信息或其他帮助。注意的是，RFID芯片270可以是有源的或无源的。进一步注意的是，对于储存第一和/或第二ECG信号轮廓来说，其他储存部件(包括系统10自身中的存储单元(memorylocation)和远端离线储存器)是可能的，其中ECG信号监控器可以以无线方式(例如经由WiFi或其他适合的无线协议)存取所述轮廓。
图7根据一个实施方案示出在导管远侧末端位置的再确认期间用于在系统10的显示器30上进行描绘的屏幕截图300的一种可能的实施例。如所示的，屏幕截图300示出ECG波形310，该ECG波形310包括波形310A和波形310B，该波形310A对应于初始导管放置时刻的第一ECG信号轮廓，该波形310B对应于如上所述的远侧末端放置的再确认时刻的第二ECG信号轮廓。在一个实施方案中，两个波形310A和310B可以被系统10校准并且叠置于彼此之上，从而使得其间的比较能够进行。在一个实施方案中，例如，初始波形310A的P-波312A可以与当前波形310B的P-波312B比较，从而确定导管远侧末端76A相对于SA结是否已发生移位。
屏幕截图300的右侧还示出关于患者、导管类型、导管长度等的附加数据314。当然，此处描绘的ECG信号和其他数据可以具有许多形式和格式中的一种或更多种。事实上，如本领域的技术人员所理解的，数据内容可以根据期望或需要而改变。例如，在一个实施方案中，初始导管放置期间峰P-波幅值以及在初始放置期间针对最终远侧末端安置的导管拉回之后的P-波幅值二者被储存，用于与在末端再确认时刻获得的相似幅值的随后比较。
因此，根据一个实施方案，公开了一种方法来再确认导管或其他留置医疗设备在患者身体中的位置。该方法包括使用患者ECG信号将医疗设备放置在患者身体中，然后在医疗设备的初始放置完成之后，储存与留置医疗设备的初始位置相关的第一ECG信号轮廓。如所述的，第一ECG信号轮廓可以被储存在患者卡上、RFID芯片上，储存在系统存储器中，书写或打印ECG信号数据，或者储存在另一适合的储存部件上。该方法还包括在医疗设备的初始放置之后的一时刻获取与留置医疗设备的位置相关的第二ECG信号轮廓，以及比较第一ECG信号轮廓与第二ECG信号轮廓来确定在医疗设备的初始放置之后留置医疗设备是否已发生移位。注意的是，比较轮廓的步骤可以由观察控制台显示器30上描绘的波形的临床医生直接进行，或者由控制台20的处理器22可执行的适合算法自动执行。
本发明的实施方案可以以其他具体的形式实施，而不偏离本发明的精神。所述已描述的实施方案应被认为是在各方面都仅是作为图示说明性的而非限制性的。因而，本发明实施方案的范围由所附的权利要求书而非前述说明书所示出。在权利要求书的含义和等同范围内的所有变化都应被包含在本发明的范围内。

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1.一种用于再确认留置医疗设备在患者身体内的位置的方法，所述方法包括：
使用患者ECG信号将所述医疗设备放置在患者身体内；
在所述医疗设备的初始放置完成之后，储存与所述留置医疗设备的初始位置相关的第一ECG信号轮廓；
在所述医疗设备的初始放置之后的一时刻，获取与所述留置医疗设备的位置相关的第二ECG信号轮廓；以及
比较所述第一ECG信号轮廓与所述第二ECG信号轮廓，以确定在所述医疗设备的初始放置之后所述留置医疗设备是否已发生移位。
2.如权利要求1所限定的用于再确认的方法，其中所述医疗设备包括导管，并且其中相对于所述导管的远侧末端确定所述医疗设备的移位。
3.如权利要求1所限定的用于再确认的方法，其中储存所述第一ECG信号轮廓的步骤包括将所述第一ECG信号轮廓储存在与所述医疗设备或所述患者相关联的部件上。
4.如权利要求3所限定的用于再确认的方法，其中储存所述第一ECG信号轮廓的步骤包括将所述第一ECG信号轮廓储存在由卡读取器可读取的卡上。
5.如权利要求3所限定的用于再确认的方法，其中储存所述第一ECG信号轮廓的步骤包括将所述第一ECG信号轮廓储存在所述医疗设备自身上。
6.如权利要求5所限定的用于再确认的方法，其中所述医疗设备包括导管，并且其中储存所述第一ECG轮廓的步骤包括将所述第一ECG信号轮廓储存在与所述导管一起被包括的RFID芯片上。
7.如权利要求1所限定的用于再确认的方法，其中储存所述第一ECG信号轮廓的步骤包括从所述医疗设备以远端方式储存所述第一ECG信号轮廓。
8.如权利要求1所限定的用于再确认的方法，其中储存所述第一ECG信号轮廓的步骤还包括经由在所述电极和所述ECG监控器之间建立的导电路径将ECG信号从与所述医疗设备相关联的电极传送至ECG监控器。
9.如权利要求8所限定的用于再确认的方法，其中比较所述第一ECG信号轮廓与所述第二ECG信号轮廓的步骤包括在所述ECG监控器的显示器上将所述第一和第二ECG信号轮廓描绘为波形。
10.如权利要求9所限定的用于再确认的方法，其中比较所述第一和第二ECG信号轮廓的步骤包括比较所述第一和第二ECG信号轮廓的P-波分量。
11.如权利要求10所限定的用于再确认的方法，其中储存所述第一ECG信号轮廓的步骤包括将所述第一ECG信号轮廓储存在所述ECG信号监控器的存储器中。
12.一种用于再确认导管在患者体内的位置的系统，所述导管邻近所述患者产生ECG信号的心脏结设置，所述系统包括：
用于获取第一ECG信号轮廓的至少一个电极，所述第一ECG信号轮廓与所述导管的远侧末端在所述患者体内的初始位置相关，所述至少一个电极还用于获取第二ECG信号轮廓，所述第二ECG信号轮廓与所述导管的所述远侧末端在所述患者体内的后续位置相关；
用于储存至少所述第一ECG信号轮廓的储存部件；以及
ECG信号监控器，所述ECG信号监控器从所述储存部件接收所述第一ECG信号轮廓并且还接收所述第二ECG信号轮廓，所述ECG信号监控器传递与第一和第二ECG信号轮廓相关的数据，从而使得能够确认所述导管的所述远侧末端的所述后续位置是否不同于所述初始位置。
13.如权利要求12所限定的用于再确认的系统，其中所述用于获取所述第一ECG信号轮廓的至少一个电极与所述患者身体内的所述导管一起被包括，并且其中所述至少一个电极通过导电路径被可操作地连接到所述ECG信号监控器。
14.如权利要求13所限定的用于再确认的系统，其中所述至少一个电极包括探针，所述探针设置在所述导管的内腔中，并且其中所述导电路径包括可操作地连接到所述至少一个电极的绳缆。
15.如权利要求12所限定的用于再确认的系统，其中所述至少一个电极和导电路径包括设置在所述导管的内腔中的导电溶液。
16.如权利要求15所限定的用于再确认的系统，其中导线被部分地设置在所述导电溶液中，所述导线从所述导管延伸并且可操作地连接到所述ECG信号监控器。
17.如权利要求12所限定的用于再确认的系统，其中所述储存部件包括RFID芯片，所述RFID芯片被包括在所述导管中，并且其中所述ECG信号监控器包括RFID编码器/读取器，来编码和读取所述RFID芯片的所述第一ECG信号轮廓。
18.如权利要求17所限定的用于再确认的系统，其中所述RFID芯片为现场可编程芯片。
19.如权利要求12所限定的用于再确认的系统，其中所述储存部件相对于所述导管以远端方式被设置。
20.如权利要求19所限定的用于再确认的系统，其中所述储存部件包括卡，所述卡包括可编程磁条，并且其中所述ECG信号监控器包括卡编码器/读取器。
21.如权利要求12所限定的用于再确认的系统，其中所述ECG信号监控器以无线方式从远端地点接收所述第一ECG信号轮廓。
22.如权利要求12所限定的用于再确认的系统，其中所述第一和第二ECG信号轮廓中的至少一个包括与所述导管的在放置之后保留在所述患者身体外部的部分的长度以及可以从中获取进一步信息的门户网站中的至少一个相关的数据。
23.如权利要求12所限定的用于再确认的系统，其中所述ECG信号监控器包括设置在所述患者内部的至少一个电极以及用于所述患者的皮肤放置的至少两个电极。
24.如权利要求12所限定的用于再确认的系统，其中第一电极被用来获取所述第一ECG信号轮廓并且第二电极被用来获取所述第二ECG信号轮廓。
25.一种用于再确认导管的远侧末端在患者的脉管系统中的位置的方法，所述方法包括：
使用患者ECG信号将导管放置在所述患者的脉管系统中；
在所述导管的初始放置完成之后，储存与所述导管的所述远侧末端的初始位置相关的第一ECG信号轮廓；
在所述导管的初始放置之后的一时刻，获取与所述导管的所述远侧末端的位置相关的第二ECG信号轮廓；以及
比较所述第一ECG信号轮廓与所述第二ECG信号轮廓，以确定在所述导管的初始放置之后所述导管在脉管系统中是否已发生移位。
26.如权利要求25所限定的用于再确认的方法，其中比较所述第一和第二ECG信号轮廓的步骤包括以可视方式观察由设置在所述患者体内的至少一个电极检测的第一和第二ECG波形。
27.如权利要求26所限定的用于再确认的方法，其中比较所述第一和第二ECG信号轮廓的步骤包括比较所述第一和第二ECG波形的P-波分量，所述第一和第二ECG波形在ECG信号监控器的显示器上以叠置的方式被描绘。
28.如权利要求25所限定的用于再确认的方法，其中比较所述第一和第二ECG信号轮廓的步骤由接收所述第一和第二ECG信号轮廓的ECG信号监控器自动执行。
29.如权利要求25所限定的用于再确认的方法，其中储存所述第一ECG信号轮廓的步骤包括：
经由至少一个血管内电极获取所述第一ECG信号轮廓；以及
将所述第一ECG信号轮廓储存在储存部件上，所述储存部件是由与ECG监控器一起被包括的编码器可编码的。
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EP2605699A2 (en) 2013-06-26
US20150080716A1 (en) 2015-03-19
WO2012024577A3 (en) 2013-09-06
BR112013002431B1 (pt) 2021-06-29
JP2013544538A (ja) 2013-12-19
WO2012024577A2 (en) 2012-02-23
KR101856267B1 (ko) 2018-05-09
US10046139B2 (en) 2018-08-14
US20120046562A1 (en) 2012-02-23
BR112013002431A2 (pt) 2017-09-12
JP5845260B2 (ja) 2016-01-20
MX338127B (es) 2016-04-04
EP2605699A4 (en) 2015-01-07

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Application publication date: 20131211