CN102209490A - 与脉管系统内的导管放置相关的器械和显示方法 - Google Patents

与脉管系统内的导管放置相关的器械和显示方法 Download PDF

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CN102209490A
CN102209490A CN2009801446638A CN200980144663A CN102209490A CN 102209490 A CN102209490 A CN 102209490A CN 2009801446638 A CN2009801446638 A CN 2009801446638A CN 200980144663 A CN200980144663 A CN 200980144663A CN 102209490 A CN102209490 A CN 102209490A
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conduit
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CN102209490B (zh
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J·B·考克斯
C·W·克鲁克
A·K·米森纳
P·D·摩根
D·R·莫里斯
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    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
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Abstract

公开了一种用于在患者的脉管系统中准确地放置导管的集成导管放置系统。在一个实施方案中，所述集成的系统包括系统控制台，用于临时放置在患者的胸部的末端定位传感器以及超声探测器。所述末端定位传感器在所述导管被设置在脉管系统中时探测设置在所述导管的内腔中的探针的磁场。在所述导管导入之前，所述超声探测器以超声方式成像脉管系统的一部分。基于ECG信号的导管末端引导被包括在所述集成的系统中，以使能所述导管末端至一相对于患者的心脏结的期望位置的引导。还公开了用于可视化和操控经由本系统所获取的ECG信号数据的显示的各方面，以及各种ECG传感器结构的各方面。

Description

与脉管系统内的导管放置相关的器械和显示方法
对相关申请的交叉引用：本申请要求2008年9月10日提交的题目为“用于在患者的脉管系统内放置导管的系统和方法(System and Method for Placing a Catheter Within a Vasculature of a Patient)”的美国临时专利申请No.61/095,921的优先权。本申请还是2009年4月17日提交的题目为“用于穿过无菌区域以进行脉管系统内的导管放置的系统和方法(Systems and Methods for Breaching a Sterile Field for Intravascular Placement of a Catheter)”的美国申请No.12/426,175的部分继续申请，该申请No.12/426,175是2008年11月25日提交的题目为“用于脉管系统内的导管放置的集成系统(Integrated System for Intravascular Placement of a Catheter)”的美国专利申请No.12/323,273的部分继续申请，该申请No.12/323,273要求如下的美国临时专利申请的优先权：2007年11月26日提交的题目为“用于脉管系统内的导管放置的集成超声和末端定位系统(Integrated Ultrasound and Tip Location System for Intravascular Placement of a Catheter)”的申请No.60/990,242，2008年9月10日提交的题目为“用于在患者的脉管系统中放置导管的系统和方法(System and Method for Placing a Catheter Within a Vasculature of a Patient)”的申请No.61/095,921，2008年8月22日提交的题目为“包括预装可操纵探针的导管(Catheter Including Preloaded Steerable Stylet)”的申请No.61/091,233，2008年9月9日提交的题目为“包括ECG和基于磁传感器的探针的导管组件(Catheter Assembly Including ECG and Magnetic-Based Sensor Stylet)”的申请No.61/095,451，以及2008年4月17日提交的题目为“穿过布单的电气连接器(Drape-Breaching Electrical Connector)”的申请No.61/045,944。本文通过引用将前面所引用的每一个申请的全部内容并入本申请。
发明内容
简要概述，本发明的实施方案涉及集成导管放置系统，所述系统被配置来在患者的脉管系统中准确地放置导管。所述集成系统采用至少两种形式来改善导管放置的准确性：1)用于将导管导入患者的脉管系统的超声辅助引导；以及2)末端定位系统(“TLS”)，或在导管通过脉管系统的推进过程中对导管末端的基于磁方式的(例如永久磁体或电磁体)追踪，以在这样的推进过程中探测并便利对任何末端错位的纠正。
在一个实施方案中，集成系统包括具有控制处理器的系统控制台，用于临时放置在患者的本体的一部分上的末端定位传感器，以及超声探测器。所述末端定位传感器在导管被设置在脉管系统中时探测设置在导管内腔中的探针的磁场。在导管导入脉管系统之前，超声探测器以超声方式成像脉管系统的一部分。此外，超声探测器包括使用者输入控制装置，所述使用者输入控制装置用于控制在超声模式中的超声探测器的使用以及在末端定位模式中的末端定位传感器的使用。
在另一实施方案中，第三种方式，即，基于ECG信号的导管末端引导被包括在所述系统中，以使能导管末端的引导至一相对于产生ECG信号的患者的心脏结(a node of the patient′s heart)的期望位置。还公开了用于在患者的无菌区域和非无菌区域之间建立导电通路以使能从导管到末端定位传感器的ECG信号通路的各种装置。这样的装置包括，例如通过在无菌屏障(例如外科手术布单)中限定的穿孔建立导电通路的连接方案，其中连接方案将穿孔隔离以防止患者的无菌区域受到污染或损害。
在进一步的实施方案中，公开了用于可视化和操控经由本导管放置系统所获取的ECG信号数据的显示的各方面。这些显示方面使临床医生能够放置所述导管或其他侵入体内的(invasive)医疗设备，以明确与所述设备相对于所述ECG信号发射节点的邻近程度(proximity)相关的信息。在另一其他实施方案中，还公开了各种ECG传感器结构的多个方面。
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集成系统的各种元件的框图；
图2为患者和借助于图1的所述集成系统被插入患者的导管的简化视图；
图3A和3B为图1的所述集成系统的探测器的视图；
图4为如被描绘在图1的所述集成系统的显示器上的超声成像的屏幕截图；
图5为在患者脉管系统中放置导管时被用来与图1的所述系统一起使用的探针的立体视图；
图6为如被描绘在图1的所述集成系统的显示器上的图标(icon)，指示在导管末端的放置过程中图5的所述探针的远侧端的位置；
图7A-7E描绘在导管末端的放置过程中可以被描绘在图1的所述集成系统的所述显示器上的各种示例性图标；
图8A-8C为在导管末端的放置过程中被描绘在图1的所述集成系统的显示器上的图像的屏幕截图；
图9为根据本发明的另一示例性实施方案，描述用于脉管系统内的导管放置的集成系统的各种元件的框图；
图10为患者和借助于图9的所述集成系统被插入患者的导管的简化视图；
图11为在患者脉管系统中放置导管时被用来与图9的所述集成系统一起使用的探针的立体视图；
图12A-12E为图11的所述探针的各部分的各种视图；
图13A-13D为用于与图9的所述集成系统一起使用的鳍状连接器(fin connector)组件的各种视图；
图13E-13F为用于与图13A-13D中示出的所述鳍状连接器组件一起使用的绳缆(tether)连接器的各种视图；
图14A-14C为示出探针绳缆与鳍状连接器以及图9的所述集成系统的传感器的连接的视图；
图15为图14C所示出的所述探针绳缆、鳍状连接器以及传感器的连接的剖视图；
图16为患者的ECG迹线的简化视图；
图17为在导管末端的放置过程中被描绘在图9的所述集成系统的显示器上的图像的屏幕截图；
图18为包括根据一个实施方案配置的电气触头的鳍状连接器的剖视图；
图19A和19B为根据一个实施方案的用于绳缆连接器和鳍状连接器的接合的电气触头保持(retention)系统的简化视图；
图20A-20C为用于结合本文所描述的所述集成系统的使用来通过无菌屏障建立信号通路的鳍状连接器和绳缆连接器的一个实施方案的各种视图；
图21A和21B为根据一个实施方案的用于将ECG电极电气连接到所述集成系统的传感器的连接器的各种视图；
图22A-22C为用于通过无菌屏障建立信号通路的鳍状连接器和绳缆连接器的一个实施方案的各种视图；
图23A和23B为根据一个实施方案的用于通过无菌屏障建立信号通路的连接器系统的剖视图；
图24为根据一个实施方案的用于通过无菌屏障建立信号通路的连接器系统的简化侧视图；
图25A和25B为根据一个实施方案的用于通过无菌屏障建立信号通路的连接器系统的简化侧视图；
图26A和26B为根据一个实施方案的用于通过无菌屏障建立信号通路的连接器系统的剖视图；
图27为根据一个实施方案的用于通过无菌屏障建立信号通路的连接器系统的简化视图；
图28为根据一个实施方案的用于与图28中示出的连接器系统一起使用的包括无菌防护体(shield)的探针的立体视图；
图29A和29B为根据一个实施方案的包括用于通过无菌屏障建立信号通路的连接器系统的图27的ECG模块的简化视图；
图30为根据一个实施方案的用于通过无菌屏障建立信号通路的连接器系统的简化视图；
图31为根据一个实施方案的用于通过无菌屏障建立信号通路的连接器系统的简化视图；
图32为根据一个实施方案的用于通过无菌屏障建立信号通路的连接器系统的元件的简化视图；
图33为根据一个实施方案的用于在无菌区域和非无菌区域之间建立导电通路的装置的视图；
图34为根据一个实施方案的用于在无菌区域和非无菌区域之间建立导电通路的另一装置的视图；
图35A-C描绘示例性P-波波形；
图36为根据一个实施方案的被改进为具有无线模块的传感器的视图；
图37为根据一个实施方案的用于连接器的保持构件视图；
图38为根据一个实施方案的包括ECG传感器的导管的立体视图；
图39为包括多个设置在导管上的电极的传感器组件的立体视图；
图40A-40C描绘图39的导管的操作；
图41A-41D为根据一个实施方案的电极连接完整性指示器和系统的各种视图；
图42为根据一个实施方案的电极连接完整性系统的立体视图；
图43A和43B为根据一个实施方案的探针的剖视图，所述探针包括用于检测探针切断情况的导线环(wire loop)；
图44为根据一个实施方案的图43A的探针的部分剖视图，所述探针包括具有平导线的导线环；
图45为根据一个实施方案的导管的剖视图，所述导管包括具有远侧干涉(interference)构件的探针；
图46为根据另一实施方案的导管的剖视图，所述导管包括具有远侧干涉构件的探针；
图47A和47B为根据一个实施方案的被配置来保持导管和探针的远侧端对齐的导管和探针的远侧部分的剖视图；
图48为根据一个实施方案的双ECG电极组件的立体视图；
图49为根据一个实施方案的包括图形的外部ECG电极组件的立体视图；
图50为根据一个实施方案的示出P-波特征的ECG迹线；
图51为描述根据一个实施方案的一种方法的流程图；
图52-55为根据本公开的实施方案的示出附加的P-波特征的ECG迹线；
图56A-57B为根据一个实施方案的示出关于ECG波形缩放的细节的ECG迹线；
图58为描述根据一个实施方案的一种方法的流程图；
图59为根据一个实施方案的包括单个ECG波形的各方面的显示窗口；
图60为描述根据一个实施方案的一种方法的流程图；
图61为根据一个实施方案被配置的导管放置记录；以及
图62为根据一个实施方案被配置的另一个导管放置记录。
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。
图1-62描绘本发明实施方案的各种特征，本发明总地涉及被配置来在患者的脉管系统中准确地放置导管的导管放置系统。在一个实施方案中，所述导管放置系统采用至少两种方式来改善导管放置的准确性：1)用于将导管导入患者的脉管系统的超声辅助引导；以及2)末端定位/导引系统(“TLS”)，或在导管通过弯曲的脉管系统路径的推进过程中对导管末端的基于磁方式的追踪，以在这样的推进过程中探测并便利对任何末端错位的纠正。根据一个实施方案，本系统的超声引导和末端定位的特征是被集成到单一设备中的，以供临床医生使用来放置导管。这两种方式被集成到单一设备中简化了导管放置过程，并得到相对更快的导管放置方式。例如，所述集成导管放置系统使超声和TLS的活动能够从所述集成系统的单一的显示器上被观察到。再者，位于所述集成设备的超声探测器(所述探测器在导管放置的过程中被保持在患者的无菌区域内)上的控制装置可以被用来控制所述系统的功能，从而消除对临床医生到所述无菌区域之外以控制所述系统的需要。
在另一实施方案中，第三种方式，即，基于ECG信号的导管末端引导被包括在所述系统中，以使能导管末端的引导至一相对于产生ECG信号的患者的心脏结的期望位置。本文也将这样的基于ECG的安置辅助称为“末端确认”。
根据一个实施方案，上述这三种方式的组合使所述导管放置系统能够以一相对较高水平的准确性便利在患者的脉管系统中的导管放置，即导管的远侧末端在预先确定的且期望的位置的放置。另外，由于所述导管末端的所述基于ECG的引导，对末端的放置进行的纠正可以无需起确认作用的X射线而被确认。这又减少了患者受到X射线的潜在害处、将患者送往X射线部门和从X射线部门送回所耗费的成本和时间、昂贵而不便的导管再安置(reposition)过程等等。
由于基于ECG信号的方式包括对以下内容的需要，即从设置在患者的无菌区域内的导管组件将ECG信号传输到设置在非无菌区域内的系统的数据接收部件，本发明的实施方案进一步涉及用于通过使所述无菌区域和非无菌区域分离的无菌屏障建立导电通路的各种连接器系统。还公开了用于可视化和操控经由本系统所获取的所述ECG信号数据显示的各方面，以及各种ECG传感器结构的多个方面。
为清楚起见，将理解到的是，本文所使用的词语“近侧的(proximal)”涉及相对地更靠近临床医生的方向，而词语“远侧的(distal)”涉及相对地更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。
首先参考描绘根据本发明的一个示例性实施方案配置的导管放置系统(“系统”)的各种部件的图1和2，所述系统一般地被标明为10。如所示的，系统10一般地包括控制台20、显示器30、探测器40以及传感器50，其中每一个均将在下面进一步详细描述。
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，这些部件的一般关系。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还包括毂(hub)74A，毂74A提供导管72的一个或更多个内腔与从所述毂向近侧延伸的一个或更多个延伸腿74B之间的流体连通。
控制台20的示例性实施方式被示于图8C中，然而，理解到的是，所述控制台可以采用各种形式中的一种。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，以控制探测器40、传感器50以及其他系统部件之间的接口连接(interfacing)。
系统10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、键盘等待。在一个实施方案中所述端口为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，显示器30被集成到控制台20中，并且在导管放置过程中被用来向临床医生显示信息。在另一实施方案中，所述显示器可以是与所述控制台分离的。如将了解到的，由显示器30所描述的内容根据所述导管放置系统所在的模式(US、TLS或在其他实施方案中的ECG末端确认)而变化。在一个实施方案中，控制台按钮界面32(见图1、8C)和被包括在探测器40上的按钮可以被用来直接由所述临床医生调用(call up)一期望的模式至向显示器30，以在放置过程中起到辅助作用。在一个实施方案中，例如在图17中，来自多种模式(例如TLS和ECG)的信息可以被同时显示。因而，系统控制台20的单一显示器30可以被用于在进入患者的脉管系统中时进行的超声引导，在通过脉管系统的导管推进过程中的TLS引导，以及(如在稍后的实施方案中的)相对于患者的心脏结的导管远侧末端放置的基于ECG的确认。在一个实施方案中，所述显示器30为一LCD设备。
图3A和3B根据一个实施方案描绘探测器40的特征。探测器40被用来与上面提到的所述第一方式一起使用，即，脉管(例如，静脉)的基于超声(“US”)的可视化，为导管72插入脉管系统做准备。这样的可视化为将导管导入患者的脉管系统提供实时的超声引导，并且有助于减少与这样的导入相关联的典型并发症，包括意外动脉穿孔、血肿、气胸等等。
手持探测器40包括容纳有压电阵列的头部80，当所述头部以抵住患者皮肤的方式邻近预期的插入部位73(图2)被放置时，所述压电阵列用来产生超声脉冲并接纳由患者本体反射后的所述超声脉冲的反射波。探测器40还包括可以被包括在按钮板(pad)82上的多个控制按钮84。在本实施方案中，系统10的方式可以是由控制按钮84控制的，因而，排除了临床医生到所述无菌区域(是在导管放置之前围绕患者插入部位形成的)之外的需要，以经由控制台按钮界面32的使用来改变模式。
这样，在一个实施方案中，临床医生采用所述第一(US)方式来确定适当的插入部位并形成脉管进入，例如利用针或导引装置，然后利用导管。然后，所述临床医生可以经由推按探测器按钮控制板82上的按钮无缝地切换到所述第二(TLS)方式，而无需到所述无菌区域之外。然后，可以使用所述TLS模式来帮助导管72通过脉管系统朝所意图的目的地推进。
图1示出探测器40还包括按钮和存储控制器42，用来控制按钮和探针的操作。在一个实施方案中，按钮和存储控制器42可以包括非易失性存储器，例如EEPROM。按钮和存储控制器42与控制台20的探测器接口44是可操作地通信的，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控制器42接口连接的按钮和存储器输入/输出部件44B。
图4示出当系统10在其第一超声方式时，如在显示器30上所描绘的示例性屏幕截图88。示出患者70的皮下区域的图像90，描绘静脉92的截面。由探测器40的所述压电阵列的操作生成图像90。同样被包括在显示器屏幕截图88上的是测深标尺指示器94、内腔尺寸比例96以及其他指示标记98，测深标尺指示器94提供关于在患者皮肤下图像90的深度的信息，内腔尺寸比例96提供关于相对标准导管内腔尺寸的静脉92的尺寸的信息，其他指示标记98提供关于系统10的状态或可能采取的动作的信息，例如，定格画面、图像模板、保存数据、图像打印、电源状态、图像亮度等等。
请注意，在其他实施方案中，当静脉被描绘在图像90中时，其他本体内腔或部分可以被成像。注意到的是，如果期望的话，在图4中所示出的所述US模式可以同时与其他模式(例如，所述TLS模式)一起被描绘在显示器30上。在导管放置期间，除可视的显示器30以外，系统10还可以采用听觉信息(例如，嘟嘟声、音调等等)来辅助临床医生。另外，包括在探测器40上的所述按钮和控制台按钮界面32可以以各种方式来配置，包括除了按钮以外使用例如滑动开关、切换开关、电子或触控感应式板等等的使用者输入控制装置。附加地，在系统10的使用期间，US和TLS二者的活动可以同时发生或单独发生。
如刚刚所描述的，手持超声探测器40被用来作为集成导管放置系统10的一部分，以使能患者的脉管系统外周的US可视化，为导管的经皮导入做准备。然而，在本示例性实施方案中，如下面所描述的，当在脉管系统中导引所述导管朝向其期望的目的地前进时，所述探测器还被用来控制系统10的所述TLS部分或第二方式的功能。再者，因为探测器40被用于所述患者的所述无菌区域中，这一特征使得能够完全从所述无菌区域中对TLS的功能进行控制。因而，探测器40为双重用途的设备，使能从所述无菌区域对系统10的US和TLS功能的方便控制。在一个实施方案中，如下面将进一步描述的，所述探测器还可以被用来控制与ECG相关的或导管放置系统10的第三方式的一些或全部功能。
导管放置系统10还包括上面提到的所述第二方式，即，基于磁方式的导管TLS或末端定位系统。在初始放入并通过患者70的脉管系统推进的过程中，所述TLS使临床医生能够快速定位并确认导管72的位置和/或定向，所述导管72例如为外周静脉穿刺中心静脉导管(“PICC”)、中心静脉导管(“CVC”)或其他适合的导管。具体地，所述TLS方式检测由装配有磁元件的末端定位探针激发的磁场，在一个实施方案中，所述末端定位探针被预装入被以纵向方式限定的导管72的内腔中，从而使所述临床医生能够确定在患者本体内所述导管末端的大体位置及定向。在一个实施方案中，可以使用如下的美国专利中的一种或更多种教导对所述磁组件进行追踪：5,775,332；5,879,297；6,129,668；6,216,028以及6,263,230。本文通过引用将前面提到的美国专利的全部内容并入本申请。所述TLS还显示所述导管末端所指向的方向，从而进一步辅助导管的准确放置。所述TLS进一步辅助临床医生确定所述导管末端的错位是何时发生的，例如在所述末端已经偏离所期望的静脉路径进入另一静脉的情况时。
如所提到的，所述TLS利用探针来使导管72的所述远侧端在其通过脉管系统的推进过程中能够被追踪。图5给出了这样的探针100的一实施例，探针100包括近侧端100A和远侧端100B。在探针近侧端100A包括有手柄，以及从所述手柄中向远侧延伸的芯线104。磁组件被设置在芯线104远侧。所述磁组件包括一个或更多个邻近探针远侧端100B被彼此相邻设置且由管108封装的磁元件106。在本实施方案中，包括有多个磁元件106，每一个元件包括与其他磁元件以端对端的方式堆叠的固体圆柱状铁磁体。粘合剂末端110可以在磁元件106远侧塞堵管108的所述远侧末端。
请注意的是，在其他实施方案中，所述磁元件不仅仅在形状方面，在组成、数目、尺寸、磁性类型以及在所述探针远侧段中的位置等方面的设计上也可以变化。例如，在一个实施方案中，所述多个铁磁元件由电磁组件替代，例如产生用于由所述传感器检测的磁场的电磁线圈。在此可用的组件的另一实施例可以从题目为“医疗器械定位装置(Medical Instrument Location Means)”的美国专利No.5,099,845中得到，本文通过引用将其全部内容并入本申请。此外，包括可以与所述TSL方式一起使用的磁元件的探针的其他实施例可以在2006年8月23日提交的题目为“探针仪器及制造方法(Stylet Apparatuses and Methods of Manufacture)”的美国申请No.11/466,602中得到，本文通过引用将其全部内容并入本申请。因此，本发明的实施方案意图包括这些和其他变体。在此应当理解的是，如本文所使用的“探针(stylet)”可以包括被配置来在所述导管的内腔中以可移除的方式放置以帮助将所述导管的远侧端放置在患者的脉管系统中期望位置的各种设备中的任一种。
图2示出探针100的设置情况，探针100基本上是在导管72的内腔中，以致探针100的所述近侧部分从所述导管内腔向近侧延伸，通过毂74A并通过延伸腿74B中选定的一个伸出。这样设置在所述导管内腔中，探针100的远侧端100B与远侧导管端76A基本上是共端头的，以致由所述探针远侧端的所述TLS所进行的相对应的探测指示所述导管远侧端的位置。
在TLS操作期间，系统10采用TLS传感器50以检测由探针100的磁元件106产生的磁场。如图2中所示的，在导管插入期间，TLS传感器50被放置在患者的胸部。将TlS传感器50放置在患者胸部的预先确定的位置(如通过使用外部本体标志(landmark))，以使能如上面所描述的被设置在导管72中的探针磁元件106的磁场，来使其在导管通行经过患者脉管系统期间被检测到。再者，因为探针磁组件的磁元件106与导管72的远侧端76A(图2)是共端头的，由TLS传感器50所进行的所述磁元件的磁场的检测向临床医生提供关于所述导管远侧端在其通行期间的位置和定向的信息。
更具体地，如图1所示的，TLS传感器50经由端口52中的一个或更多个可操作地连接到系统10的控制台20。请注意的是，在所述TLS传感器和所述系统控制台之间还可以使用其他连接方案而不受限制。正如所描述的，磁元件106被用在探针100中以使导管远侧端76A(图2)相对被放置在患者的胸部的TLS传感器50的位置能够是可观察到的。在TLS模式期间，由TLS传感器50所进行的探针磁元件106的检测以图形化的方式被显示在控制台20的显示器30上。以这种方式，放置所述导管的临床医生能够大体确定在患者脉管系统中导管远侧端76A相对TLS传感器50的位置，并且检测导管错位(例如，所述导管沿非期望的静脉所进行的推进)是何时发生的。
图6和7A-7E示出图标的实施例，所述图标可以被控制台显示器30使用以描绘由TLS传感器50所进行的探针磁元件106检测。特殊地，图6示出当所述磁元件被安置在所述TLS传感器下方时，描绘探针100的所述远侧部分(包括如被TLS传感器50所检测的磁元件106)的图标114。因为探针远侧端100B与导管72的远侧端76A基本上是共端头的，所述图标指示所述导管远侧端的位置和定向。图7A-7E示出当探针100的磁元件106没有被安置在TLS传感器50的正下方(但在仍能被检测到的附近)时，可以被描绘在控制台显示器30上的各种图标。所述图标可以包括根据所述探针磁组件的位置(即，在本实施方案中，磁元件106相对TLS传感器50的位置)而被显示的半图标114A和四分之一图标114B。
图8A-8C描绘在TLS模式中取自系统10的显示器30的屏幕截图，示出探针100的所述磁组件是如何被描述的。图8A的屏幕截图118示出TLS传感器50的表征性图像120。被提供在显示器屏幕截图118上的其他信息包括测深标尺指示器124、状态/动作指示标记126以及与被包括在控制台20上的按钮界面32(图8C)相对应的图标128。尽管在本实施方案中，图标128是简单的指示器以引导使用者辨识按钮界面32相对应的按钮的用途，在另一实施方案中，所述显示器可以被制成触控感应式的，从而所述图标自身可以起到按钮界面的作用并且可以根据所述系统所在的模式而改变。
在插入患者的脉管系统后导管通过脉管系统推进的初始阶段期间，与探针远侧端100B基本上具有共端头的导管72的远侧端76A是相对距TLS传感器50较远的。这样，所述显示器屏幕截图将提示“无信号”，指示来自所述探针磁组件的磁场未被检测到。在图8B中，邻近探针远侧端100B的所述磁组件，尽管其没有在所述传感器的正下方，已经推进到足够接近TLS传感器50而能被检测到。这由被示出在传感器图像120的左侧的半图标114A所指示，表征所述探针的磁组件从患者的视角来看是被安置在TLS传感器50的右侧的。
在图8C中，邻近探针远侧端100B的所述磁组件已经在TLS传感器50的下方推进，以致其相对的位置和定向能被所述TLS传感器检测到。这由在传感器图像120上的图标114指示。请注意的是，按钮图标128提供可以通过按压控制台按钮界面32中相对应的按钮来实现的动作的提示。这样，按钮图标128可以根据系统10所在的方式而改变，从而为按钮界面32提供使用上的灵活性。请进一步注意的是，因为探测器40的按钮控制板82(图3A、3B)包括可以模仿按钮界面32中的多个按钮的按钮84，在保持于所述无菌区域中的同时，显示器30上的按钮图标128向临床医生提供引导以利用探测器按钮84控制系统10。例如，如果临床医生需要离开TLS模式并返回US(超声)模式，在探测器按钮控制板82上的适当控制按钮84可以被按压，并且所述US模式可以立即被调用，同时显示器30刷新到适应US功能所需的所述可视信息，如图4中所示。这无需临床医生到所述无菌区域之外即可实现。
现在参考图9和10，根据另一示例性实施方案描述集成导管放置系统10。同上，如上面所描述的，集成系统10包括控制台20、显示器30，用于US功能的探测器40，以及用于末端定位功能的TLS传感器50。请注意的是，图9和10中所描绘的系统10在诸多方面与图1和2所示的系统是相似的。由此，下面仅对选出的不同之处进行讨论。图9和10的系统10包括附加的功能，其中导管远侧末端76A相对窦房(“SA”)或患者70的心脏的其他电脉冲发出结的接近度的确定可以被确认，从而提供增强的能力来准确地将所述导管远侧末端放置在邻近所述结的期望位置。另外，本文称之为“ECG”或“基于ECG的末端确认”，系统10的这一第三方式使能来自所述SA结的ECG信号的检测，以将所述导管远侧末端放置在所述患者脉管系统中期望位置。请注意的是，所述US、TLS以及ECG方式在本系统10中被无缝地组合，但是可以被一同使用或单独使用来帮助放置导管。在一个实施方案中，要理解的是如本文所描述的ECG方式可以被包括在独立(stand-alone)系统中而不包括US和TLS方式。因此，本文描述的实施方案所处的环境被理解为仅仅是示例性的环境而不能被认为是对本公开的限制。
图9和10示出根据本实施方案另外被配置有探针130的系统10。就整体而言，导管探针130被以可移除的方式预先设置在经由插入部位73被插入到患者70的导管72的所述内腔中。探针130，除了包括用于基于磁方式的TLS方式的磁组件之外，包括邻近其远侧端的传感部件(即ECG传感器组件)，并且包括与所述导管末端的所述远侧端共端头的一部分，用于探测由所述SA结产生的ECG信号。与先前的实施方案相比之下，探针130包括从其近侧端延伸的绳缆134，绳缆134可操作地连接到TLS传感器50。如将被进一步以细节描述的，在作为所述基于ECG信号的末端确认方式的一部分的所述导管末端位置的确认过程中，探针绳缆134允许由被包括在探针130的远侧部分上的所述ECG传感器组件所检测到的ECG信号被传送到TLS传感器50。参考和接地ECG芯/电极对158附接到患者70的本体，并且被可操作地附接到TLS传感器50以使能所述系统来滤掉与心脏的SA结的电活动无关的高电平电活动，从而使能所述基于ECG的末端确认功能。接收自被放置在患者皮肤上的ECG芯/电极对158的参考信号和接地信号，与由所述探针ECG传感器组件探测的所述ECG信号一起被安置在患者胸部的TLS传感器50(图10)或系统10的其他指定的部件接收。如将要描述的，TLS传感器50和/或控制台处理器22可以处理所述ECG信号数据以在显示器30上产生心电图波形。在TLS传感器50处理所述ECG信号数据的情况下，处理器被包括在其中以实现意图的功能。如果控制台20处理所述ECG信号数据，处理器22、控制器24或其他处理器可以在所述控制台中被应用，以处理所述数据。
因此，随着其推进通过患者脉管系统，如上面所描述的，装配有探针130的导管72可以在安置在患者的胸部上的TLS传感器50(如图10所示)下推进。这使TLS传感器50能够检测探针130的所述磁组件的位置，探针130的所述磁组件与定位在患者的脉管系统中的所述导管的远侧末端76A基本上是共端头的。在ECG模式期间，由TLS传感器50进行的所述探针磁组件的检测被描绘在显示器30上。在ECG模式期间，显示器30还描绘由探针130的所述ECG传感器组件所检测到的患者心脏电活动的结果所产生的ECG心电图波形。更具体地，包括P-波波形的所述SA结的所述ECG电活动由所述探针的所述ECG传感器组件(下面描述)检测，并且被传送至TLS传感器50和控制台20。然后，所述ECG电活动被处理以在显示器30上进行描述。随后，放置所述导管的临床医生可以观察所述ECG数据来确定导管72的远侧末端76A的最佳放置，例如在一个实施方案中是邻近所述SA结。在一个实施方案中，控制台20包括接收并处理由所述探针ECG传感器组件所检测的所述信号的必要的电子部件(例如处理器22(图9))。在另一实施方案中，TLS传感器50可以包括处理所述ECG信号的必要的电子部件。
如已经讨论过的，在所述导管的放置过程中，显示器30被用来向临床医生显示信息。显示器30的内容根据所述导管放置系统所在的模式(US、TLS或ECG)而改变。临床医生可以立即调用这三种模式中的任一种到显示器30，并且在一些情况下，来自多种模式(例如TLS和ECG)的信息可以同时被显示。在一个实施方案中，和前面一样的，所述系统所在的模式可以由包括在手持探测器40上的控制按钮84控制，从而排除了临床医生到所述无菌区域之外(例如，触控控制台20的按钮界面32)以改变模式的需要。因而，在本实施方案中，探测器40还被用来控制系统10的与ECG相关的一些或全部功能。请注意的是，按钮界面32或其他输入结构也可以被用来控制系统功能。同样，在导管放置期间，除了使用可视的显示器30以外，所述系统还可以采用听觉信息(例如，嘟嘟声、音调等等)来辅助临床医生。
现在参考图11-12E，描述探针130的一个实施方案的各种细节，探针130以可移除的方式被装入导管72中并且在插入期间被用来将所述导管的远侧末端76A安置在患者脉管系统中的期望位置。如所示出的，当从所述导管移出时，探针130限定近侧端130A和远侧端130B。连接器132被包括在近侧探针端130A，并且绳缆134从所述连接器向远侧延伸并附接到手柄136。芯线138从手柄136向远侧延伸。在一个实施方案中，探针130被预装入导管72的内腔中，以致远侧端130B在所述导管远侧端76A处(图10)与所述导管开口基本上是齐平或共端头的，并且以致芯线138的近侧部分、手柄136以及绳缆134从延伸管74B中选定的一个向近侧延伸。注意到的是，尽管本文以探针进行描述，在其他实施方案中，导丝或其他导管引导器械可以被包括在本文所描述的实施方案的原理中。
芯线138限定细长的形状并且是由适合的探针材料构成，包括不锈钢或记忆材料，例如在一个实施方案中的包含镍和钛的合金(通常公知的缩写为镍钛诺(“nitinol”))。尽管未在本文中示出，在一个实施方案中，芯线138由镍钛诺来制造使所述芯线与所述探针的远侧段相对应的所述部分能够具有预成形的弯曲结构，从而促使导管72的所述远侧部分形成相似的弯曲结构。在其他实施方案中，所述芯线不包含预成形。进一步地，所述镍钛诺结构增强芯线138的扭转能力，以使当被设置在导管72的所述内腔中时探针130的远侧段能够被操控，这又使所述导管的所述远侧部分在导管插入期间能够被导引通过脉管系统。
提供手柄136来使能所述探针对导管72的插入/移除。在探针芯线138是可扭转的实施方案中，手柄136进一步使所述芯线在导管72的所述内腔中能够被旋转，以帮助导引所述导管远侧部分通过患者70的脉管系统。
手柄136附接到绳缆134的远侧端。在本实施方案中，绳缆134是具有弹性、受屏蔽的线缆，绳缆134包容一条或更多条电气连接到芯线138(起到上面所涉及的所述ECG传感器组件的作用)以及绳缆连接器132的导线。这样，绳缆134提供从芯线138的所述远侧部分通过绳缆连接器132至探针130的近侧端130A的导电通路。如将要解释的，绳缆连接器132被配置来可操作地连接到在患者胸部上的TLS传感器50，用来帮助将导管远侧末端76A导引至患者脉管系统中的期望位置。
如在图12B-12D所见的，芯线138的远侧部分从接合点142向远侧是逐渐变细的或在直径上是减少的。套管140在所述减少直径的芯线部分上滑动。尽管在此具有相对较大的直径，在另一实施方案中，所述套管可以被选择尺寸来基本上匹配所述探针芯线的所述近侧部分的直径。探针130还包括被邻近其远侧端130B设置的用于在TLS模式期间使用的磁组件。在所述图示说明的实施方案中，所述磁组件包括被设置在减少直径的芯线138的外表面和套管140邻近探针远侧端130B的内表面之间的多个磁元件144。在本实施方案中，磁组件144包括20个固体圆柱状的以类似于图2的探针100的方式被端对端地堆叠的铁磁体。然而，在其他实施方案中，所述磁元件可以不仅仅在形状方面，而且在组成、数目、尺寸、磁性类型以及在所述探针中的位置等方面的设计上也可以变化。例如，在一个实施方案中，所述磁组件的所述多个磁体由产生用于由所述TLS传感器检测的磁场的电磁线圈替代。因此，本发明的实施方案意图包括这些和其他变体。
磁元件144被用于探针130的远侧部分中以使探针远侧端130B相对被放置在患者胸部上的TLS传感器50的位置能够是可观察到的。如已经提及的，随着具有所述探针的导管72推进通过患者脉管系统，TLS传感器50被配置来检测磁元件144的磁场。以这种方式，放置导管72的临床医生能够大体确定导管远侧端76A在患者脉管系统中的位置并且检测导管错位(例如，所述导管沿非期望的静脉的推进)是何时发生的。
根据一个实施方案，探针130还包括前面提到的ECG传感器组件。在插入期间，所述ECG传感器组件使设置在导管72的内腔中的探针130能够被用来检测由SA或其他患者心脏结所产生的心房内ECG信号，由此允许将导管72的远侧末端76A导引至在脉管系统中邻近患者心脏的预先确定的位置。因此，所述ECG传感器组件在确认导管远侧末端76A的合适放置位置中起辅助作用。
在图11-12E中所图示说明的实施方案中，所述ECG传感器组件包括邻近探针远侧端130B设置的芯线138的远侧部分。芯线138是具有导电性的，使ECG信号能够被其所述远侧端检测并且能够被沿所述芯线向近侧传输。导电材料146(例如，导电性环氧树脂)填充邻近芯线138的所述远侧终端的套管140远侧部分，从而与所述芯线的所述远侧端是以导电方式连通的。这又增加了探针130的远侧端130B的所述导电表面，从而改善了其检测ECG信号的能力。
在放置导管之前，探针130被装入导管72的内腔中。请注意的是，可以由制造商将探针130预装入所述导管内腔，或在插入导管之前由临床医生装入所述导管。探针130被放置在所述导管内腔中，以致探针130的远侧端130B与导管72的远侧末端76A基本上是共端头的，从而使所述探针和所述导管二者的所述远侧末端基本上是彼此对齐放置的。如已经描述过的，导管72和探针130的所述共端头使所述磁组件能够在TLS模式中与TLS传感器50一起起到这样的作用，即随着导管远侧末端76A在患者脉管系统中所进行的推进来追踪其位置。然而，请注意的是，就系统10的所述末端确认功能而言，探针130的远侧端130B无需与导管远侧端76A共端头。相反，所需的仅是在脉管系统和所述ECG传感器组件之间的导电路径，在这种情况下就是芯线138，以致所述SA结或其他患者心脏结的电脉冲可以被检测到。在一个实施方案中，这一导电路径可以包括各种成分，包括，盐溶液、血液等等。
在一个实施方案中，一旦导管72已经经由插入部位73(图10)被导入患者脉管系统，可以采用如已经描述过的系统10的所述TLS模式来朝向导管远侧末端76A邻近所述SA结的所意图的目的地推进导管远侧末端76A。靠近心脏区域后，系统10可以被切换到ECG模式以使由所述SA结发出的ECG信号能够被检测到。随着所述装有探针的导管朝向患者的心脏被推进，包括芯线138的所述远侧端和导电材料146的所述导电性ECG传感器组件开始检测由所述SA结所产生的电脉冲。这样，所述ECG传感器组件起到检测所述ECG信号的电极的作用。邻近所述芯线远侧端的细长的芯线138作为导电通路来将由所述SA结所产生的且由所述ECG传感器组件所接收到的电脉冲传送到绳缆134。
绳缆134将所述ECG信号传递到被临时放置在患者胸部上的TLS传感器50。绳缆134被可操作地经由绳缆连接器132或其他适合的直接或间接的起连接作用的结构连接到TLS传感器50。如所描述的，然后所述ECG信号可以被处理并且被描绘在系统显示器30上(图9、10)。对由TLS传感器50接收并由显示器30显示的所述ECG信号进行的监控，使临床医生能够随着导管远侧末端76A朝向所述SA结的推进，观察并分析在所述信号中发生的变化。当所接收到的ECG信号匹配一期望的轮廓(profile)时，临床医生可以确定导管远侧末端76A已到达一相对于所述SA结的期望位置。如所提到的，在一个实施方案中，这一期望位置位于所述SVC的下三分之一(1/3)部分内。
所述ECG传感器组件以及磁组件可以合作来辅助临床医生在脉管系统中放置导管。一般地，探针130的所述磁组件在从初始的导管插入开始的总的脉管系统引导中辅助临床医生，以将导管72的远侧端76A放置在患者心脏的总的区域内。然后，随着所述探针ECG传感器组件靠近所述SA结，通过使临床医生能够观察到由心脏所产生的所述ECG信号中所发生的变化，所述ECG传感器组件可以被用来在所述SVC中将导管远侧端76A引导至期望位置。再有，一旦观察到适合的ECG信号轮廓，临床医生可以确定探针130和导管72二者的远侧端已经抵达相对于患者心脏的所述期望位置。一旦导管72已经如所期望地被安置，导管72可以被固定在适当位置，并且探针130从所述导管内腔移除。在此，请注意的是，所述探针可以包括除本文已经明确描述过的以外的各种结构中的一种。在一个实施方案中，所述探针可以被直接地附接到所述控制台而不是间接地经由所述TLS传感器进行附接。在另一实施方案中，使能其TLS和与ECG相关的功能的探针130的结构可以被集成到所述导管结构自身中。例如，在一个实施方案中，所述磁组件和/或ECG传感器组件可以被并入所述导管的壁。
图13A-15根据本实施方案，描述关于从探针绳缆134到被安置在患者胸部上的TLS传感器50的ECG信号数据通路的各种细节。具体地，这一实施方案涉及自围绕导管72和插入部位73的无菌区域的ECG信号数据的通路(包括探针130和绳缆134)，以及非无菌区域，例如其上被安置有所述TLS传感器的患者胸部。这样的通路应当不会破坏所述无菌区域而使其无菌性受损害。在所述导管的插入过程中被安置在患者70上的无菌布单限定所述无菌区域的大部分：在所述布单之上的区域是无菌的，而在其下方的(不包括所述插入部位和紧紧围绕的区域)是非无菌的。如将可见的，下面所进行的讨论包括与探针130相关联的至少一第一连通节点，以及与TLS传感器50相关联的第二连通节点，彼此可操作地进行连接以使ECG信号数据能够在二者间传输。
图13A-15中所描绘的是这样的一个实施方案，即解决从所述无菌区域到所述非无菌区域而不影响前者无菌性的ECG信号数据的通路问题，描绘“穿过布单(through-drape)”的实施方式，也被称为“鲨鱼鳍(shark fin)”的实现方式。具体地，如上面所描述的，图14A示出在导管的插入过程中用于放置在患者胸部上的TLS传感器50。TLS传感器50包括在其顶部表面的限定凹槽152A的连接器底部152，在凹槽152A中设置有三个电气底部触头154。同样在图13A-13D中示出的鳍状连接器156被选择尺寸，来如图14B和15中所示出的以滑动的方式被连接器底部152的凹槽152A所接纳。两个ECG芯/电极对158从鳍状连接器156延伸，用于放置在肩部和躯干或患者本体上的其他适合的外部位置。布单-穿过绳缆连接器132被配置来以滑动的方式配接鳍状连接器156的一部分，以实现如将在下面进一步描述的从探针120通过所述无菌区域到TLS传感器50的导电通路。
图13A-13D示出鳍状连接器156的其他各方面。具体地，鳍状连接器156限定被选择尺寸来被连接器底部152的凹槽152A接纳(图14B、15)的下筒形部分160。由中心锥面164所围绕的孔162被包括在上筒形部分166的后端上。上筒形部分166被选择尺寸来接纳探针130的绳缆连接器132(图14C、15)，以致延伸进入绳缆连接器132的凹槽172(图15)的针触头170被所述中心孔引导，直到其就位于鳍状连接器156的孔162中，从而使所述绳缆连接器与所述鳍状连接器互相连接。接合件(如在图13C和13D中所示出的接合件169)可以被包括在鳍状连接器156的任一侧上，以与在绳缆连接器132上的相对应的止动件(detent)173(图13F)接合，来帮助保持在这两个部件之间的配接(mating)。如果这两个部件之间的脱离是期望的，在握紧或固定鳍状连接器156的同时向绳缆连接器132施加足够的回转拉力，以防止鳍状连接器156从连接器底部152的凹槽152A移除。
图13D示出鳍状连接器156包括多个电气触头168。在本实施方案中，三个触头168以这样的形式被包括：两个最前面的触头的每一个电气连接ECG芯158中的一个的终端，并且后面的触头延伸进入孔162的轴向邻近区域，从而当绳缆连接器132的针触头170配接鳍状连接器156时(图15)，电气连接绳缆连接器132的针触头170。鳍状连接器156的每一个触头168的底部分被安置来电气连接TLS传感器连接器底部152的底部触头154中相对应的一个。在一个实施方案中，每一个触头168的底部分包括保持构件，例如凹进(indentation)168A。如此的配置以致当鳍状连接器156由TLS传感器连接器底部152接收时，每一个触头168可以柔韧地接合底部触头154中各自的一个，从而每一个底部触头的末端被接收在各自的凹进168A中。这样的配置提供附加的固定(图15)来帮助防止鳍状连接器156从连接器底部152提早分离。要注意的是，本文已示出并描述的之外，在底部触头154和鳍状触头168之间还可以包括许多不同的保持构件。
图13E和13F根据一个实施方案描绘绳缆连接器132的各种细节，包括如上面所描述的绳缆连接器凹槽172、设置在所述凹槽内的针触头170以及用于以可移除的方式接合鳍状连接器156(图13A-13D)的接合件169的止动件173。图13E还示出多个作为可以被包括以帮助临床医生握紧绳缆连接器132的结构的实施例的抓握(gripping)件171。
图14B示出用于将上面所描述的部件互相连接的第一连接阶段，其中通过所述鳍状连接器的下筒形部分160与连接器底部凹槽152A的滑动接合，使鳍状连接器156以可移除的方式配接TLS传感器连接器底部152。这一接合使连接器底部触头154和相对应的鳍状触头168电气连接(图15)。
图14C示出第二连接阶段，其中通过绳缆连接器凹槽172与所述鳍状连接器的上筒形部分166之间的滑动接合，使绳缆连接器132以可移除的方式配接鳍状连接器156。如在图15中最佳可见的，这一接合使绳缆连接器针触头170和鳍状连接器156的后触头168电气连接。在本实施方案中，绳缆连接器132相对于鳍状连接器156的水平滑动运动与当所述鳍状连接器被以可滑动的方式配接到所述传感器连接器底部凹槽152A时(图14B)的滑动运动是在相同的接合方向上。在一个实施方案中，探针130/绳缆连接器132中的一个或两个以及鳍状连接器156是一次性的。同样，在一个实施方案中，所述绳缆连接器在所述鳍状连接器已经被配接到所述TLS传感器之后，可以被配接到所述鳍状连接器，而在另一实施方案中，所述绳缆连接器可以在所述鳍状连接器被配接到所述TLS传感器之前，先通过外科手术布单被配接到所述鳍状连接器。
在图14C所示的连接方案中，探针130经由绳缆连接器132被可操作地连接到TLS传感器150，因而使所述探针的所述ECG传感器组件能够将ECG信号传送到所述TLS传感器。另外，ECG芯/电极对158被可操作地连接到TLS传感器50。然而，在一个实施方案中，绳缆连接器132被称为用于探针130的第一连通节点，而鳍状连接器156被称为用于TLS传感器50的第二连通节点。如将会看到的，可以利用各种其他的第一和第二连通节点来使能所述ECG传感器组件和所述TLS传感器或其他系统部件之间的导电通路的建立。
请注意的是，各种其他起到连接作用的方案和结构可以被用来在所述探针和所述TLS传感器之间实现可操作的连通。例如，所述绳缆连接器可以使用片触头而不是针触头来刺穿所述布单。或者，所述鳍状连接器可以是与所述TLS传感器一体地形成的。因此，这些和其他结构被包含在本发明的实施方案的范围内。
如所提到的，布单174通常被放置在患者70之上，并且被用作屏障来将诸如所述布单之上并且邻近插入部位73的区域和部件(包括导管72、探针130以及绳缆134(图10))的患者的无菌区域，从诸如所述布单之下的区域和部件(包括患者的胸部、放置在胸部上的传感器50(图10)以及在此也被称为是非无菌区域的紧紧围绕患者70的区域)的所述无菌区域外的非无菌区域分离。如在图15中所见的，在导管的放置期间被用来形成无菌区域的无菌布单174被放置在绳缆连接器132和鳍状连接器156的相互连接之间。正如所描述的，绳缆连接器132包括被配置来在所述两个部件相配接的时候刺穿布单174的针触头170。这样的刺穿在由针触头170占据的无菌布单174中形成小洞或穿孔175，从而将由所述针触头形成的所述布单穿孔的尺寸最小化。另外，绳缆连接器132和鳍状连接器156之间的配合是这样的，以致在无菌布单中由针触头170的穿过形成的所述穿孔由绳缆连接器凹槽172包围，因而保持所述布单的所述无菌性并且防止所述布单中的裂口可能损害由此形成的所述无菌区域。绳缆连接器凹槽172被这样成形并配置，以在被针触头170刺穿之前将无菌布单174向下折，以致所述针触头在被设置为邻近鳍状连接器156的孔162之前不会刺穿所述布单，并且以致所述布单在所述凹槽内不会打褶(bunch up)。在此，请注意的是，绳缆连接器132和鳍状连接器156被这样配置，以便利其间通过不透明的无菌布单174的以不可见的方式的(blindly)对准，即，经由临床医生在不可见的情况下对两个部件所进行的触摸检查。
如已经提到的，请进一步注意的是，如在图15中所示的鳍状连接器156的鳍状触头168包括被配置来以这样的方式配接传感器底部触头154的凹进168A，即帮助保持所述鳍状连接器与传感器底部凹槽152A的接合。这又减少对将鳍状连接器156固定到TLS传感器50的附加器械的需求。在其他实施方案中，与所述电气触头分离的保持构件可以用来帮助保持所述鳍状连接器和所述传感器底部凹槽的接合。在一个实施方案中，底部触头154可以被配置为弹簧针(pogo pins)，从而底部触头为垂直地可移动的(displaceable)以帮助保持鳍状连接器156。
图16示出包括P-波和QRS波群的患者的典型ECG波形176。并且对于本系统10来说，一般地，所述P-波的幅度根据所述ECG传感器组件离产生波形176的P-波的所述SA结的距离而变化。临床医生可以在确定所述导管末端何时被恰当地邻近心脏安置时使用这一关系。例如，在一个实施方式中，如已经讨论过的，所述导管末端以期望的方式被放置在所述上腔静脉的下三分之一(1/3)内。由探针130的所述ECG传感器组件所检测的所述ECG数据被用来再现波形(例如，波形176)，用于在ECG模式期间在系统10的显示器30上进行描述。
现在参考图17，根据一个实施方案，描述当系统10在ECG模式(将在下面进一步描述的所述第三方式)中时，在显示器30上所显示的ECG信号数据的各方面。显示器30的屏幕截图178包括所述TLS方式的多个要素，包括TLS传感器50的表征图像120，所述表征图像120具有在通行穿过患者脉管系统期间对应于探针130的所述远侧端的位置的图标114。屏幕截图178还包括窗口180，由探针130的所述ECG传感器组件捕获并由系统10处理的当前ECG波形被显示在窗口180中。随着新波形被检测到，窗口180不断地被刷新。
窗口182包括对最新被检测到的ECG波形所进行的连续描绘，并且包括刷新条182A，随着所述波形被检测到，刷新条182A横向地移动以刷新所述波形。窗口184A被用来显示在所述ECG传感器组件被放到所述SA结的邻近范围之内以前所捕获到的基线ECG波形，用于比较的用途以帮助临床医生确定是何时抵达的所述期望的导管末端位置。当使用者按压在探测器40或控制台按钮界面32上的预先确定的按钮时，窗口184B和184C可以呈现由使用者所选出的检测到的ECG波形。在窗口184B和184C中的所述波形被保留直到由使用者经由按压按钮或利用其他输入装置所进行的选择而引发的新波形所覆盖。如在先前的模式中，测深标尺124、状态/动作指示标记126以及按钮图标128被包括在显示器30上。完整性指示器186也被包括在显示器30上，来给出所述ECG芯/电极对158是否被可操作地连接到TLS传感器50和患者70的提示。
因而，如上面所见的，在一个实施方案中显示器30在单一屏幕上同时描绘所述TLS方式和ECG方式二者的各要素，从而为临床医生提供丰富的数据以帮助将所述导管远侧末端放置在期望位置。请进一步注意的是，在一个实施方案中，所述屏幕截图的打印输出或所选出的ECG或TLS数据可以被保存、打印，或者由系统10保留以使能恰当的导管放置的文件记录。
尽管本文所描述的实施方案涉及特别结构的导管，例如PICC或CVC，这样的实施方案仅仅为示例性的。因此，本发明的原理可以被扩展到大量不同结构和设计的导管。
图18-19B描绘用于绳缆连接器132和鳍状连接器156的触头接合结构的实施例。具体地，图18根据一个实施方案描绘鳍状连接器156的鳍状触头168，其中所述后面的触头包括弹簧夹结构168B，用来经由被限定在所述鳍状连接器中的中心锥面164或其他孔接收绳缆连接器132的针触头170(图15)。图19A和19B根据另一实施方案描绘接合方案，其中绳缆连接器132的针触头170包括尖头件(barbed feature)170A，尖头件170A当被插入鳍状连接器156的中心锥面164或其他孔时接合被限定在所述鳍状连接器的后面的鳍状触头168上的肩168C，以帮助防止所述针触头从所述鳍状连接器提早移除。因此，这些实施方案用作可以与鳍状连接器156、传感器连接器底部152以及绳缆连接器132一起被包括的各种触头结构的非限制性实施例。注意的是，除非另行限定，本文所描述的所述触头被理解为包括在建立导电通路中使用的电气触头。
下面结合附图20A-32要被描述的实施方案中的每一个将示例性连接方案描绘为这样的装置，即用来在患者的无菌区域和非无菌区域(即所述无菌区域外的区域)之间建立导电或其他连通通路的装置。因此，本文所描述的实施方案用作对应于用来建立导电或其他连通通路的装置的结构、材料和/或组成的实施例。特别地，本文所描述的各种实施方案公开用来穿过或是绕开将所述无菌区域与所述非无菌区域分离的无菌屏障的实施例，以提供用于从传感部件(例如探针130的所述ECG传感器组件)到传感器50(在本文中也被称为TLS传感器或胸部传感器)或者系统10的其他适合的数据接收部件的ECG信号传送的导电通路的至少一部分。注意的是，这些实施方案仅仅为用来建立这样的导电或连通通路的各种装置的实施例，而不能被认为是对本公开的范围的限制。因此，要理解的是，用来建立导电或其他连通通路的装置可以被用来传输ECG信号或其他信息、电信号、光信号等。
如将会看到的，要被描述的许多实施方案包括在本文中也被称为第一连通节点的绳缆连接器，该第一连通节点可操作地连接到探针130并且被包括在所述无菌区域中，所述绳缆连接器被配置来可操作地附接到被包括在传感器50或系统10的其他适合的部件上的连接器，该传感器或连接器在本文中也被称为第二连通节点，该第二连通节点被设置在所述无菌区域外。然而要注意的是，第一连通节点和第二连通节点一般地被意图为涉及各种连接器接口，所述连接器接口提供如上面所描述的从所述无菌区域到所述非无菌区域的导电通路，以使能ECG信号的传送。要理解的是，所述导电通路为连通通路并且包括电通路、光通路等。另外，在此所描述并考虑的连通节点连接方案可以与这样的系统一起被利用，即包括除ECG信号外的其他方式的使用的系统，用于导管或其他医疗设备的导引或放置。
进一步注意到的是，描述用于穿过布单或其他非透明无菌屏障的结构的要遵循的实施方案被这样配置，以致便利临床医生对设置在布单/屏障下面的视线之外的连通节点的位置的触摸，从而方便所述第一和第二连通节点的定位和连接。再有，本文所描述的许多连接器结构可以被配置为一次性使用可抛弃的部件，以使与感染相关的顾虑最小化。
现在参考图20A-20C，根据一个实施方案将连接方案描绘为这样的装置，即用来在无菌区域和非无菌区域之间建立导电通路的装置。具体地，图20A-20C描绘了绳缆连接器232，绳缆连接器232包括外壳体234和附接到所述外壳体的片状刃(blade)支撑器236。片状刃触头238由片状刃支撑器236固定，以致所述片状刃触头延伸到所述绳缆连接器的凹槽240中。片状刃触头238用来当绳缆连接器232被滑入来以前面实施方案中所描述的方式接合所述鳍状连接器时，在被置于所述绳缆连接器和鳍状连接器256之间的布单中创建划破(slice)穿孔。如前面一样的，所述绳缆连接器的外壳体234包住(envelop)并保护所述穿孔，以防止所述无菌区域受到污染和损害。
图20C示出鳍状连接器256包括鳍状触头268，鳍状触头268被配置来当所述绳缆连接器被滑入到鳍状连接器256上时与片状刃触头238实质上互相连接，从而通过所述鞘建立导电通路，以使得来自ECG传感部件(例如即为上面描述的所述ECG传感器组件)的ECG信号能够经由片状刃触头238/鳍状触头268接合传到传感器50。注意的是，片状刃和鳍状触头的具体结构可以不同于在此所描述的内容。例如，如果期望，绳缆连接器可以包括两个或更多个片状刃或触头，用来与相对应的鳍状触头接合，以使多条导电通路能够被建立。绳缆连接器和鳍状连接器的接合面也可以不同于所示出并描述的内容。在一个实施方案中，光源可以与鳍状连接器或如本文所描述的其他连接器一起被包括，以通过布单174提供照明并且在定位鳍状连接器方面提供视觉辅助，用于与绳缆连接器的互相连接。
如在图14A和14B中所见的，在一个实施方案中，ECG芯158被永久地连接到鳍状连接器156。图21A描绘另一可能的实施方案，其中ECG芯经由连接器(例如在图21B中最佳可见的马蹄形连接器270)以可移除的方式被附接到鳍状连接器156。图21A还示出鳍状连接器156被永久地附接到传感器50。因此，系统10的各种部件的连接方案中的这些和其他变体被意图为落入本公开的范围。在另一实施方案中，每一个芯的电极是以从所述芯可移除的方式可附接的，例如经由卡扣连接(snap connection)。
现在参考图22A-22C，根据一个实施方案将连接方案描绘为这样的装置，即用来在无菌区域和非无菌区域之间建立导电通路的装置。具体地，图22A-22C描绘包括凹槽372的绳缆连接器332，用来以类似于前面实施方案的方式，可滑动地接合设置在传感器50上的鳍状连接器356的上筒形166。绳缆连接器332包括双向可安置的顶部帽374，针触头370或其他刺穿触头被附接到双向可安置的顶部帽374。
当绳缆连接器332首先被滑入到鳍状连接器356上时，顶部帽374被安置在图22B中虚线所示出的未被致动的第一位置。类似于前面的实施方案，布单被置于鳍状连接器356的上筒形166和绳缆连接器凹槽372之间，为清楚起见而被移除。绳缆连接器332被安置在鳍状连接器356上之后，顶部帽374则可以被临床医生按压到图22B中示出的被致动的第二位置，其中针触头370被向下压通过布单并且被压到与设置在鳍状连接器356中的相对应的触头可操作的接合。因而，绳缆连接器332如图22C中所示的被安置。除了通过布单174建立导电路径之外，针触头370的这种接合将绳缆连接器332锁合到鳍状连接器356上，以防止所述部件的提早分离。
现在参考图23A和23B，根据一个实施方案将连接方案描绘为这样的装置，即用来在无菌区域和非无菌区域之间建立导电通路的装置。具体地，图23A描绘包括针触头440或附接到致动组件442的其他适合的触头的绳缆连接器432。致动组件442包括杠杆臂，用来选择性地使针触头440降低而通过由壳体446(致动组件被设置于壳体446中)的公端头448限定的开口。壳体的公端头448被配置为由设置在传感器50或系统的其他适合的部件(例如可操作地连接到传感器的远程模块)上的传感器连接器插孔(receptacle)450接收。
为使绳缆连接器432与传感器连接器插孔450互相连接，在布单174之上绳缆连接器432的公端头448被拿到邻近插孔450的位置。致动组件442则通过如在图23B中示出的抬高杠杆臂444来致动。针触头440被迫使向下降而通过布单174，从而在其中限定穿孔。然后，公端头448可以被完全接收到传感器插孔450中，其中针触头440可操作地与传感器连接器插孔的适合的触头连接。图23A和23B中示出的连接器方案对于连接器互相连接期间在患者本体上施加最小向下的力是有用的。另外，致动组件442在使第一连通节点(绳缆连接器432)与第二连通节点(传感器连接器插孔450)连接过程中提供预先确定的力，并且从而不依赖于临床医生对建立节点连接的用力的估量。在另一实施方案中，致动组件442被致动来使触头440刺穿通过布单之前，壳体446和传感器插孔450可以被对准并配接。
现在参考图24，根据一个实施方案将连接方案描绘为这样的装置，即用来在无菌区域和非无菌区域之间建立导电通路的装置。如在图23A和23B所示出的实施方案中，节点的互相连接期间，本互相连接方案使患者本体上的向下的压力最小化。如所示的，绳缆连接器532包括针触头540或与带螺纹的帽542一起被包括的其他适合的触头，带螺纹的帽542在其内侧面上限定螺纹。带螺纹的帽542被配置来以螺接方式接收设置在传感器50或系统的其他适合的部件(例如可操作地连接到传感器的远程模块)上的带螺纹的底部544。如前面一样的，布单174被置于二者之间。
为使绳缆连接器532与传感器50互相连接，在布单174之上绳缆连接器的带螺纹的帽542被拿到邻近带螺纹的底部544的位置并被螺接到所述底部之上。这导致针触头540刺入布单174，从而在其中限定穿孔。进一步将帽542螺接到底部544之上导致针触头540接合被包括在底部544中的触头插孔546，从而可操作地使所述两个节点互相连接。在一个实施方案中，绳缆134被可旋转地附接到带螺纹的帽542，以防止绳缆在螺接期间的缠绕(twisting)。由于经由螺接操作，用来连接这两个连接器的力相对于患者被横向地引导，图24中示出的连接器方案对于连接器互相连接期间在患者本体上施加最小向下的力是有用的。进一步注意的是，本公开意图包括各种螺接结构和位置以及不同的帽和底的结构。
现在参考图25A和25B，根据一个实施方案将连接方案描绘为这样的装置，即用来在无菌区域和非无菌区域之间建立导电通路的装置。如在前面的实施方案中，本互相连接方案使在所述节点的互相连接期间患者本体上的向下的压力最小化。如在图25A和25B中所描绘的，绳缆连接器632包括一个或更多个刺穿触头，例如分别被包括在滑动臂642A和642B上的针触头640A和640B。一个或更多个触头插孔(例如触头插孔644A和644B)被包括在传感器50的一部分(例如传感器鳍646)或其他适合的系统部件上。如前面那样的，布单174被置于绳缆连接器632和传感器鳍646之间，以用作无菌屏障。
为使绳缆连接器632与传感器鳍646互相连接，在布单174之上绳缆连接器被拿到邻近传感器鳍的位置，从而滑动臂642A和642B跨于传感器鳍而以致如图25A中示出的，针触头640A和640B与相对应的触头插孔644A和644B对准。然后，滑动臂642A和642B被朝向彼此滑动，以致针触头640A和640B刺入布单174，每个针触头在布单中限定一个穿孔。滑动臂642A和642B被向内滑动直到如在图25B中可见的，针触头640A和640B就位于其中并且可操作地与相对应的触头插孔644A和644B连接，从而使这两个节点互相连接。由于用来连接这两个连接器的力相对于患者被横向地引导，图25A和25B中示出的连接器方案对于连接器互相连接期间在患者本体上施加最小向下的力是有用的。进一步注意的是，绳缆连接器、传感器鳍以及触头的具体结构可以不同于本文所明确描述的内容。例如，在一个实施方案中，滑动臂可以被配置为双向可安置的摇臂，所述摇臂以跷跷板的结构相对于彼此连接。再者，一个、两个或更多个触头可以被包括在滑动臂上。
现在参考图26A和26B，根据一个实施方案将连接方案描绘为这样的装置，即用来在无菌区域和非无菌区域之间建立导电通路的装置。如所示的，集成连接器730被并入到布单174中，以使能穿过其中的可操作的互相连接。在图示说明的实施方案中，集成连接器730包括导电底部部分734，从导电底部部分734延伸机械式连接器，例如卡扣球736A和736B。
如在图26B中示出的，集成连接器730被固定在布单174中，以至于与以下部件均是可连接的，即绳缆连接器732的适合的插孔738和传感器50的适合的插孔740二者或者是系统10的其他适合的部件。具体地，绳缆连接器732可以被卡扣附接到集成连接器730，此后集成连接器可以被附接到传感器50，从而为这样的信号提供适合的通路，即来自无菌区域中的ECG传感器组件、要通过布单174的无菌屏障被传输至非无菌区域中的传感器的信号。要理解的是，在其他实施方案中，集成连接器可以包括其他结构，例如不同的机械式连接器，如摩擦连接器、公/母连接器等等，并且这样在绳缆连接器和传感器上的插孔可以同样被修改来适应不同的机械式连接器。再者，上面描述的连接方案可以为反过来的，从而插孔被包括在集成连接器上而卡扣球被包括在各自的绳缆连接器和传感器上。此外，尽管当前是被描绘为单个(unitary)部件，在其他实施方案中集成连接器可以包括两个或更多个部分，这些部分在其制造期间通过前面所限定的布单中的孔而被相互附接。因此，意图包括这些和其他变体。
现在参考图27，根据一个实施方案将连接方案描绘为这样的装置，即用来在无菌区域和非无菌区域之间建立导电通路的装置。具体地，图27描绘设置在患者的无菌区域外的中间模块，即可操作地经由传感器线缆752连接到系统10的传感器50的ECG模块750。ECG模块750还被可操作地连接到ECG芯158。在一个实施方案中，ECG模块750包括对由探针130的ECG传感器组件检测到的ECG信号的接收和分析所需要的电路和其他部件。这样，探针130和ECG模块750之间的导电通路通过横贯患者的无菌区域来建立。在本实施方案中，这是通过绳缆134的绳缆连接器762来实现的。
如在图27中所描绘的，绳缆连接器762可操作地附接到ECG模块750的插孔764。如所示出的，绳缆连接器762可以包括足够长的手柄，所述手柄使临床医生能够将无菌绳缆连接器附接到非无菌ECG模块750的插孔764，而不触碰ECG模块本身，从而防止无菌区域受到任何损害。在一个实施方案中，绳缆连接器762的手柄可以包括例如可延伸的挂钩(J-hook)触头，该挂钩触头可以可操作地连接到ECG模块的适合的触头。
图27还描绘一可以与本文所描述的任一实施方案一起使用的脚踏开关1116，脚踏开关1116可以被放置在靠近临床医生双脚的地面上，并且被用来在导管放置过程中控制系统功能的选定方面。例如，在一个实施方案中，脚踏开关1116可以被用于在系统显示器30上定格ECG波形图像，或者在所述过程中或甚至是在所述过程结束之后创建显示器的打印输出，从而提供最终导管放置的记录。当然，脚踏开关的设计和功能可以以在本文中被明确示出并描述的许多方式来修改。
图28根据一个实施方案示出作为连接方案的一部分的绳缆连接器的另一实施例，该绳缆连接器可以与图27的ECG模块750或者与系统10的其他适合的部件一起使用，该连接方案被描绘为用来在无菌区域和非无菌区域之间建立导电通路的装置。具体地，图28描绘绳缆连接器832，绳缆连接器832在其近侧端包括手柄和尖触头836或其他适合的触头。无菌防护体838被置于手柄834和触头836之间。在以类似于图27所示出的方式将触头836插入ECG模块750的插孔764中时，无菌防护体838帮助保护临床医生的手。因此，无菌防护体838起到附加屏障的作用，来防止临床医生与无菌区域外的部件(例如ECG模块750)意外接触。注意的是，无菌防护体和/或其他绳缆连接器的尺寸、形状和具体结构可以不同于在本实施方案中所明确描述的内容。
图29A和29B根据一个实施方案示出连接方案的又另一实施例，该连接方案可以与图27的ECG模块750或者与系统10的其他适合的部件一起使用，该连接方案被描绘为用来在无菌区域和非无菌区域之间建立导电通路的装置。具体地，图29A示出ECG模块750可以被无菌袋850包住。连接器(例如上面结合图26A和26B所描述的集成连接器730)可以被并入到所述袋中。如在图29B中示出的，集成连接器730的内卡扣球或其他机械式连接器可以被ECG模块750的适合的相对应插孔764接收。系统10的绳缆连接器则可以可操作地与集成连接器730的外卡扣球或其他连接器连接，从而在无菌区域和非无菌区域之间建立导电通路而不损害无菌性。注意的是，无菌袋850可以包括各种适合材料(包括塑料)中的任何一种或更多种。还要注意的是，除了本文所明确描述的内容集成连接器可以包括其他连接器结构。在一个实施方案中，无菌袋不包括集成连接器，而是由绳缆连接器的针触头(例如被包括在图28的绳缆连接器832上的尖触头836)刺穿。
现在参考图30，根据一个实施方案将连接方案描绘为这样的装置，即用来在无菌区域和非无菌区域之间建立导电通路的装置。具体地，如在前面的实施方案中那样，探针130包括作为第一连通节点的绳缆连接器862。还包括作为第二连通节点的远程传感器连接器864，并且远程传感器连接器864被可操作地经由远程传感器连接器线缆866连接到系统10的传感器50。绳缆连接器862和远程传感器连接器864可操作地沿连接接口868彼此连接。起到无菌屏障作用的布单174被置于绳缆连接器862和远程传感器连接器864之间的连接接口868，并且适合的布单刺穿结构与绳缆连接器和远程传感器连接器一起被包括，来建立通过布单的导电通路。因而，本实施方案公开一个这样的实施方案，其中第二连通节点相对于传感器50被远程地定位。
现在参考图31，根据一个实施方案将连接方案描绘为这样的装置，即用来在无菌区域和非无菌区域之间建立导电通路的装置。具体地，如上面结合图30所描述的，本发明包括可操作地沿连接接口868彼此连接的绳缆连接器862和远程传感器连接器864。本实施方案中的远程传感器连接器864被放置在邻近导管插入部位73的区域中，在该区域之上被限定在布单174(为清楚起见，布单的部分被省略)中的窗孔(fenestration)880被这样安置，来使临床医生在导管放置期间能够接近(access to)插入部位。围绕插入部位的区域被消毒以为导管插入做准备之前，在使用粘合剂、胶带等的情况下，远程传感器连接器864被附着到患者的邻近导管插入部位73的皮肤。因此，当插入部位被消毒时，远程传感器连接器864也被消毒。稍后，当将绳缆连接器862连接到远程传感器连接器864时，临床医生可以握住远程传感器连接器864而不损害患者的无菌区域。理解的是，绳缆连接器和远程传感器连接器的具体结构可以变化而仍属于本实施方案的范围内。
现在参考图32，根据一个实施方案将连接方案描绘为这样的装置，即用来在无菌区域和非无菌区域之间建立导电通路。具体地，图32示出针对US功能，系统10所采用的如上面结合图3A和3B所描述的探测器40。无菌鞘900被放置在探测器40之上，以使探测器进入患者的无菌区域。连接接口(例如插孔910)被包括在探测器900上并且被这样配置，以与绳缆连接器920是可操作地可连接器的。例如，在一个实施方案中，绳缆连接器920包括刺入无菌鞘900的针触头，来通过这样的方式与插孔910配接以防止无菌区域受到污染。以这种方式，作为第一连通节点的绳缆连接器920可操作地与作为第二连通节点的探测器40连接。例如在图31中可见的，探测器40又可操作地连接到系统控制台20，以使由探针130的ECG传感器组件经由绳缆连接器920接收的ECG信号能够如上面所描述的那样被传送至控制台、传感器50或者用于进行处理的其他系统部件。在另一实施方案中，插孔910或其他适合的连接接口可以被包括在将探测器40连接到系统控制台20的线缆上。插孔910和绳缆连接器920的具体接触结构可以根据本领域技术人员的理解而变化。例如，在一个实施方案中，集成连接器(例如图26A和26B中所示出的)可以被并入到无菌鞘中。进一步注意的是，尽管在本实施方案中包括塑料，如本文所描述的无菌鞘可以包括其他适合的材料来提供无菌性。
现在参考图33，根据一个实施方案描绘用来在无菌区域和非无菌区域之间建立导电通路的装置。如所示出的，绳缆134包括被包括在无菌区域之中的无线模块950，无线模块950起到第一连通节点的作用，用来以无线的方式(经由RF或其他适合的频率或频率范围)将从探针130的ECG传感器组件接收到的ECG数据传输至作为第二连通节点的数据接收部件，例如传感器50或系统10的其他适合的部件。无线模块接地电极952被可操作地与无线模块950连接，用来在邻近导管插入部位73的无菌区域中放置。系统接地电极158A从传感器50延伸，用来在无菌区域外而邻近导管插入部位73和无线模块接地电极952的位置放置。用于系统接地电极158A的一种可能的放置位置为如图33中所描绘的在患者手臂下方。如在前面的实施方案中的，系统参考电极158B被放置在患者70的下躯干或其他适合的位置上。注意的是，如本文所讨论的无线模块和系统控制台可以以各种方式中的一种或更多种来配置，并且包括在此没有详细描述的用于无线信号传输和接收的部件，例如微带天线(patch)或其他天线、信号变换器等等。
在系统被以如图33中示出的方式配置的情况下，系统接地电极158A可以为电气驱动的，从而其生成由无源无线模块接地电极952探测的电压，给出其相对于系统接地电极的邻近位置。这使得二接地电极基本上是等电势的，从而使无线模块950能够使用无线模块接地电极952，而ECG信号来自探针130的ECG传感器组件(例如在一个实施方案中的芯线138(图12C-12E))，来检测ECG数据并以无线的方式将ECG数据传输至传感器50，用来与由系统参考电极158B探测的数据进行比较，以获得期望的P-波波形(如图16)。在一个实施方案中，数据比较为在由探针130的ECG传感器组件、无线模块接地电极952与系统参考电极158B获得的ECG数据之间的差分比较。在一个实施方案中，系统接地电极158A与无线模块接地电极952类似，可以为无源的并且不是电气驱动的。还要注意的是，在传输到传感器50或其他系统部件(例如控制台20)之前，模拟的ECG数据可以被数字化或者由无线模块950处理。
图34根据一个实施方案将又另一无线结构描述为这样的装置，即用来在无菌区域和非无菌区域之间建立导电通路的装置。如所示出的，在位置A的正电极954A和在位置B的负电极954B与传感器50一起被包括，并且被安置在患者70的躯干上，而被标示在位置C的正无线模块电极956与无线节点950一起被包括，正无线模块电极956被安置在患者邻近导管插入部位73上或邻近导管插入部位73中。探针130的ECG传感器组件，例如在一个实施方案中的芯线138，针对所描绘的结构的无线部分起到负电极(以其最终位置被标示于图34中的D处)的作用。注意的是，在一个实施方案中，电极954A和954B的位置A和B在患者本体上可以分别被改变，来为最佳的ECG信号接收协调系统10。
在本实施方案中，电极954A和954B为采样双极ECG信号起到第一独立源的作用。来自这些电极的ECG数据被数字化，并且经由使传感器50和无菌区域外的控制台互相连接的线缆(路径1)被传送至控制台20或其他适合的系统部件。无线模块电极956和ECG传感器组件为采样双极ECG信号起到第二独立源的作用。来自这些电极的ECG数据被数字化，并且经由在无菌区域内的无线模块950(路径2)被以无线的方式传送至控制台20。因此，在本实施方案中，无线模块950起到第一连通节点的作用，而控制台20的无线接收器起到第二连通节点的作用，用来在两个节点之间进行ECG信号的转换。注意的是，在其他实施方案中，前面提到的电极的极性可以是反过来的。
沿路径1和2二者接收到的ECG信号由控制台20的适合的电路来进行基线矫正，以针对DC偏置和漂移进行调整。在这样的矫正之后，可以生成未改变的参考或基线，例如在图35A中可见的来自路径1的P-波波形176A。类似地，从路径2中生成如在图35B中可见的P-波波形176B，这样的波形随着导管72中的探针130被朝向患者的心脏推进而改变。在这样的推进期间，来自路径2的波形176B被从来自路径1的P-波波形176A中减去，例如利用数字差分放大器。这种减去移除由信号中的每一个所表征的波形的所有共有分量，并且例如通过图35C中示出的波形176C可见的，使控制台20能够经由其显示器30来仅仅描绘这两个信号中的不同之处。在导管推进期间，来自路径2的波形的P-波中的改变则可以被容易地观察到。因此，本实施方案使得要被表征的ECG数据的数字显示是容易地可观察的，而防止用于这样的数据传输的无菌屏障(例如外科手术布单)的物理穿过。
注意的是，在其他实施方案中，无线模块电极956可以包括其他结构，包括被嵌入到导引装置鞘中的导电元件，与患者的血流相接触，该导引装置鞘在导管放置期间通常被通过插入部位73来设置。在一个实施方案中，导引装置可以在其近侧部分上包括连接器，来使其与无线节点950的接触得以进行。
还要注意的是，根据本文所描述的实施方案，各种无线协议中的一个或更多个可以被用来传输无线信号，包括IEEE 802.11族的规范中的一个或更多个等等。还要注意的是，在一个实施方案中，无线模块可以与用于可操作地通过鞘连接无线模块电极的连接器一起被包括在如在前面的实施方案中所描述的无菌鞘中，以在无菌区域中拿起该模块，或者无线模块自身被包括在鞘中。当然，还可以采用其他方法来将无线模块保持在无菌区域中。在一个实施方案中，无线模块可以包括按钮，该按钮进一步从无菌区域内使能系统10的控制。
图36示出在一个实施方案中，传感器50可以被改进(retro-fitted)为具有无线模块960，以使由传感器接收到的信号能够被以无线的方式传输至控制台20或系统10的其他适合的部件。例如，由接地和参考电极158A、158B(图34)接收到的ECG数据可以被传感器50接收，然后经由无线模块960以无线的方式被传输至系统控制台。无线模块960可以包括天线或其他传输部件并且可以可操作地经由传感器线缆962或其他适合的接口连接到传感器50。注意的是，无线模块960可以与本文所描述的其他实施方案结合使用，包括例如图10和33中所描绘的实施方案。
图37根据一个实施方案示出保持构件，用来防止鳍状连接器156从传感器连接器底部152或与鳍状连接器可操作地连接的其他插孔意外分离。如所示出的，鳍状连接器156包括被柔韧地附接到鳍状连接器本体的保持臂970。保持臂970包括舌(tab)972，当鳍状连接器156被可滑动地接收在传感器凹槽152A中(图14A)时，舌972在与传感器50的连接器底部152一起被包括的边缘(lip)974之上滑动并与边缘974接合。舌972与边缘974的接合防止鳍状连接器156在使用中的意外移除。当鳍状连接器156从传感器连接器底部152的移除是期望的时，保持臂970被抬起，以使舌972从边缘974脱离，此后鳍状连接器可以在不与传感器凹槽152A接合的情况下被滑动。这样的结构可以与其他保持构件(例如凹进168A(图13D))一起使用或单独使用。注意的是，在其他实施方案中，可以采用各种修饰和结构来帮助保持鳍状连接器和连接器之间的接合。例如，在一个实施方案中，保持臂可以被可操作地附接到鳍状触头168(图13D)中的一个或更多个，从而保持臂或其他适合的鳍状连接器部件的替换(例如横向地抬起移动、挤压等)使一个或更多个鳍状触头从底部触头(图15)脱离，从而减少由鳍状触头和底部触头的接合所提供的整体保持力。进一步注意的是，这些原理可以被应用到除了在此所描述的鳍状连接器以外被公开或意图包括的其他连接器方案。
除了上面将各种连接方案描绘为这样的装置的实施方案以外，即用来在无菌区域和非无菌区域之间建立导电通路的装置，可以根据本领域技术人员的理解利用其他配置来实现相同的功能。这样的其他配置可以包括，例如ECG信号从探针到传感器或系统部件的无线传输、包括布单中的导电性螺接、包括无菌布单中的导电性窗口(例如，由导电性塑料或金属箔构成的)等等。在又另一实施方案中，探针/导丝的近侧端自身可以被用来刺穿布单，以接收进入到传感器上的连接器中。在这种情况下，没有绳缆被包括在探针的近侧端上，而探针自身起到导电通路的作用，用来将ECG信号从探针传感器组件传输到患者胸部上的传感器。这样的结构可以允许使用如在此所描述的探针/导丝来进行导管的丝上放置。这样，上面的实施方案不应当以任何方式被理解为是对本发明的限制。
图38示出导管982，作为可以与本文所公开的实施方案中描述的导管放置系统10一起被使用的导管的一个实施例。导管982包括安置在邻近远侧端982B处(然而，沿所述导管的其他位置也是可能的)的导电环形带984，导电环形带984起到ECG传感器或电极的作用，用于在导管至少部分地被插入患者的脉管系统时检测从患者70的心脏结发出的ECG信号。导线986沿导管982的长度延伸并且在一个实施方案中被嵌入(例如通过共挤)导管壁，用于与患者外部的外部ECG信号接收部件的连接。要注意的是，除了上述的那些之外且本领域技术人员理解的，这只是导管和ECG传感器电极结构的一个示例性实施方案。此外，其他可能的结构被公开于2009年8月21日提交的题目为“包括ECG传感器和磁性组件的导管组件(Catheter Assembly Including ECG Sensor and Magnetic Assemblies)”的美国专利申请No.12/545,762中，通过引用将其全部内容并入本申请。
图39根据一个实施方案示出用于与包括ECG传感器组件990的系统10一起使用的导管982，其中所述导管包括多个ECG传感器或者电极994A、994B以及994C。电极994C被安置在邻近导管远侧端982B处，而剩下的电极994A和994B被安置在所述导管上邻近电极994C处。每个电极可操作地连接到各自的导电通路，例如沿导管的长度从电极向近侧延伸的导线，从而使被检测的ECG信号能够被传送到外部TLS传感器50或者其他适合的系统部件。电极994A-994C可以以适合作为传感器以检测患者心脏的ECG信号的多种结构中的一个或更多个来配置。再者，尽管被示出为封口的，但在一个实施方案中导管982可以为开口的。
如在图40A-40C中所示，ECG传感器组件990可以被用来确定导管远侧端982B对SA结的邻近程度，其中在图示说明的实施方案中，导管982的传感器组件包括两个电极994A和994B。在图40A中，当导管远侧端982B接近SA结时，分别由导管电极994A和994B检测的ECG波形的P-波996A和996B二者示出P-波幅度上的增加。然而，因为其相对更加邻近SA结的位置，电极994B示出具有相对更大幅度的P-波。例如，如由系统10检测到的P-波996A和996B的叠加以998被示出。例如，在系统显示器上观察这种关系可以在导管的放置期间为临床医生给出所需的信息，从而帮助导管远侧端982B朝向SA结的推进。
图40B示出当两个电极994A和994B相对于SA结等距时，P-波996A和996B的幅度是大致相等的，这个事实由P-波的叠加998来进一步示出。在图40C中，远侧电极994B比电极994A相对更远离SA结，并且这样其相应的P-波996B相对于P-波996A是较小的。要注意的是，电极的类型和数目可以不同于在此所示出的。
在另一实施方案中，滤波过程可以与在此描述的导管982的ECG电极994A、994B的使用结合进行，其中由电极检测的ECG波形的部分除了P-波部分都被除去，仅仅留下在这两个电极之间的被检测到的P-波中的不同来进行描绘。该过程类似于如上所述的结合图34-35C所进行的过程。
图41A-41C描绘针对ECG电极完整性指示器186的各种可能的状态，也被示出为图17中的系统显示器30的屏幕截图178上所显示的。完整性指示器186是在系统显示器30上所显示的图标，并且是连接完整性部件的部分，以利用外部传感器50检验各种ECG信号路径的连接状态，即连接是否闭合并且是否准备好在导管放置过程中使用。这样的引线检验是有益的，以避免如果在放置无菌布单且建立围绕患者的无菌区域之前各种ECG电极没有恰当地连接时，不得不移除无菌布单并重新开始放置过程。
在图41A中，完整性指示器186示出当前到外部传感器50没有为闭合的连接。相反，图41B示出传感器50和ECG电极158(图14B)之间的连接是闭合的，通过带阴影的连接符号1004来指示。图41C示出除此之外，传感器50和探针130的ECG传感器之间的连接(例如图12C和12D中的芯线138经由绳缆134和绳缆连接器132)也是闭合的，如带阴影的连接符号1006所指示的。因此，图41A中的完整性指示器视图表征图14A中示出的连接状态，图41B中的指示器视图表征图14B中示出的连接状态，并且图41C中的指示器视图表征图14C中示出的连接状态。
系统10可以使用连接完整性部件以各种方式中的一个或更多个确认上述连接的状态，所述连接完整性部件包括例如与传感器50和/或控制台20一起被包括的电容或电感感测电路、基于阻抗的方法、时间或频率反射法技术等等。一种可能的基于电压平衡的连接完整性部件系统在图41D中以1120示出。具体地，如图41D所示，系统1120的电路包括第一电阻对1120和可操作地经由通信线路1126连接的放大器1124(例如仪表放大器)作为本系统的另一部件。第二电阻对1128、放大器1130和1132、模拟数字转换器(“ADC”)1134以及处理器1136也被包括在所述系统中并且如图41D所示地相互连接。在一个实施方案中，处理器1136被包括在外部TLS传感器50中，但是可以被并入其他系统处理器或被包括在其他部件中，例如一个实施方案中的控制台20中。系统10的各种ECG电极被示出附接到患者70的本体，即诸如以图12A-12E中示出的结构的探针芯线138的内部ECG传感器(图41D中的E1)，以及图14A-14C中示出的外部参考外部ECG电极158(E2)和第二外部电极(E3)二者。
在针对使用系统10的准备中，完整性检查系统1120在一个实施方案中可以被用来确保外部ECG电极被恰当地连接到患者70的本体以及系统10的外部TLS传感器50二者。以1140示出的参考电压Vref例如通过稳压器被驱动到预先确定的值，例如4伏特，而外部电极E3处的电压被保持在相对低的值，例如2伏特。分别来自于图41D中的电极1和2的电压值V1和V2被平均以生成以1142表示的共模电压Vcm。在一个实施方案中，当经由ADC 1134被采样时，处理器1136监控Vcm。当外部ECG电极E2和E3被恰当地连接到患者本体和TLS传感器50时，Vcm在数值上将被拉低，在一个实施方案中接近约2伏特，然而其他值也是可能的。然而，如果外部电极E2和E3中的一个或两个没有被恰当地连接，Vcm将被拉高至Vref的值，或者在本实施方案中为约4伏特。这样，由处理器1136对Vcm的监控可以确定外部ECG电极的连通性。与外部ECG电极的连通性状态相关的这些数据可以通过处理器1136被传送到显示器30，用于通过图41A-41C中示出的显示器30上的指示器186进行描绘。
图42根据一个实施方案示出又另一可能的连接完整性部件结构，其中采用无源引线连续性检查系统，消除对从系统10的各种ECG电极延伸的引线注入电流的任何需要。如所示的，辐射元件1010被包括在相对地靠近诸如在传感器50上的ECG电极引线处。辐射元件1010被配置来发射已知频率的信号。ECG引线(例如外部ECG电极158和绳缆134的线)作为天线无源地检测辐射元件1010辐射的信号。当ECG引线被恰当地附加到传感器50时，ECG引线的天线效应被最小化，以致出现在ECG引线上的辐射信号被抑制。传感器和/或控制台电路被这样配置以检测出现在ECG引线上的辐射信号并将其与阈值信号水平进行比较。如果被检测的辐射信号在所述阈值之上，系统报告ECG引线没有被恰当地连接。当被检测的信号低于所述阈值时，系统报告所述引线被恰当地连接。本结构是无源的并且无需向ECG引线传输电流以检查针对连接路径检查的连接完整性。
在一个实施方案中，图42的连接检查示意图可以被配置，以致出现在引线上的不同等级的信号水平将指示在ECG电极上游的子连接是否闭合。在另一实施方案中，自然地出现在引线上的自然频率60Hz、120Hz或180Hz中的自然信号线路噪声可以被用于检测，由此消除对辐射元件1010的需要。
要理解的是，其他图标和设计可以被用来实现结合图41A-41C所描述的功能，并且该连接状态检查可以根据对导管放置系统所做的修改而改变。当然，其他视觉或听觉指示可以被用来传达电极连接状态。
图43A-43B描绘包括一模式的探针结构的细节，所述模式用于例如当导管72在被插入患者70之前被修剪(trim)时所述探针被不合期望地留在导管内腔中，检查此时探针130是否已经被不经意地切割(cut)。如所示的，在一个实施方案中，探针130可以包括被管套(tubing sleeve)1018覆盖的芯线1014和多个磁性元件1016，以及被包括在探针远侧端的导电性环氧树脂1020。导线环1024被包括在探针中并且在探针130的远侧端130B形成回路，从而当与系统10适当地连接时形成电路。由此，导线环1024限定检查探针远侧部分的连续性的连续电路。如果探针已经被不经意地切割，例如通过如图43B中所示的不恰当的导管修剪，所述回路是开路的并且所述连续性检查失败，表示导管末端已经被损害。连续性检查可以在导管72被插入到患者的脉管系统之前被执行，以防止在插入之后的导管引导问题。在另一实施方案中，导线环1024可以被配置来被暴露于患者血液并且附加地起到ECG电极的作用。
图44示出对先前实施方案的许多可能改变中的一个，其中导线环1024被实施为偏向于在最小厚度的平面内弯曲的平导线。这样的平导线可以被用在诸如图44中所示的具有预先弯曲的结构的探针中。另外，在一个实施方案中，如果期望的话，这样的线使能探针弯向要被沿一个轴控制的方向。的确，在一个实施方案中，张力可以被赋予所述平导线，以例如如图44中所示地导致探针130的远侧部分选择性地从笔直转向弯曲结构。应当要注意的是，刚刚描述的实施方案可以以这样的探针来实现，所述探针具有在结构、尺寸等方面的各种结构中的一个。在其他实施方案中，要注意的是，在其他实施方案中，其他技术(例如包括使用时域或频域反射法的探针检查)可以被用来确保所述探针并未已经被切割或者被损害。
图45和46描绘用于防止探针130在导管72内的非预期的向近侧推进的机械方案。具体地，图45示出被包括在探针远侧端130B上的球状机械干涉构件1028，以阻碍探针缩入导管内腔。图46示出另一实施例，其中所述探针远侧端130B包括被转向的延伸部分干涉构件1028。当然，可以利用许多不同尺寸和形状的机械干涉构件，包括箭头形、球形等等。
图47A和47B描绘辅助防止导管72和探针130的远侧端未对齐的电气方案。如所示的，导电带1032被嵌入所述导管，以与探针130的两个导电部分1036电气连通，非导电探针部分1034被置于所述两个导电部分1036之间。当探针远侧端130B被恰当地对齐导管72的远侧端72B时，更远侧的探针导电部分1036经由嵌入导管的导电带1032被导电地连接到更近侧的探针导电部分1036。然而，如果探针和导管远侧端130B、72B没有对齐，则没有这样的导电路径被建立，并且这种路径的缺失可以通过系统10的传感器50、控制台20或者其他适合的部件来检测，以使能其修正。
图48描绘用于在导管放置过程中放置在患者70的皮肤上的双ECG电极组件1040的一个可能的实施方式。如所示的，组件1040包括双电极1042A、1042B、用于简化ECG引线放置的单个盘。还包括相应的引线1044。在其他实施方案中，如果期望的话，ECG电极组件可以包括多于两个电极。
图49示出用于放置在患者70的皮肤上的外部ECG外部电极组件的一个实施例，包括前述的鳍状连接器156和外部ECG电极158。图形1048被安置在每个电极158的表面上，图形1048包括辅助临床医生将ECG电极放置在患者的本体上适合位置的图示。这辅助可能不熟悉在患者的本体70上用于电极的适合放置位置的临床医生。图示和具体的电极结构可以根据系统设计而改变。
图50-61描绘用于在导管放置系统的显示器(例如图10的系统10的显示器30)上显示ECG数据的各种可能的实施方式，用于辅助临床医生将导管放置到患者70的脉管系统中。在要遵循的许多实施方式中，呈现和显示ECG数据的标准方法被改进来帮助导管放置和末端定位的确认。这样，如下的显示和计算方法对向临床医生呈现数据可以是有用的。
图50示出可闻(audible)或其他适合的反馈可以结合显示ECG迹线(例如在此示出的ECG迹线1050)被利用，所述反馈类似于在图17中的显示器屏幕截图178上所描绘的迹线历史窗口182。具体地，在一个实施方案中，声音或其他指示可以与ECG信号的ECG波形的一方面相关。在本实施方案中，可闻提示与ECG迹线1050中的每个波形176的P-波1052的幅度相关联。随着P-波幅度如图50所示的变化，可闻提示可以相应地变化。可闻提示可以在频率、音量、连续性(例如单独点击相对连续音调)等方面被调制。
图51示出描绘一方法的一个实施方案的流程图，所述方法用于就ECG波形176的一方面(例如P-波1052的幅度)进行相关且产生可闻或其他反馈。该方法在整体或部分上可以由系统10的适合部件(例如被包括在外部传感器50或控制台20中的电路)，或者其他适合的导管或医疗设备放置系统来执行和/或控制。在步骤1056中，在导管放置过程中，ECG信号数据以诸如在上面结合系统10的使用已经进行描述的方式被采样。在步骤1058中，ECG波形从被采样的ECG信号数据被识别。在步骤1060中，ECG波形的P-波部分被识别。这可以通过诸如比较所述波形的部分与标准的预先加载的P-波模板以确定P-波1052的存在和位置来实现。然后在步骤1062中确定P-波的幅度峰值。在步骤1064中，P-波幅度峰值与相应的可闻或其他适合的反馈输出相关。在一个实施方案中，该步骤可以通过系统10被预先确定并储存，或者可以动态地自动或通过使用者输入被控制。然后在步骤1066中产生输出。要注意的是，在其他实施方案中，输出可以除了如已经被描述的可闻部分之外，包括例如可视、光/声结合、机械运动(振动)和/或其他感官提示，或者前述的组合。
图52-55使用图51所描绘的方法，给出可以与ECG信号数据的多个方面(例如每个被检测的ECG波形的P-波幅度)相关的可视输出的进一步的实施例。例如，图52示出一个显示实施方式，其中每个ECG波形176的P-波1052被识别并利用颜色被突出显示以区分P-波与所述波形的其他部分。在一个实施方案中，所述颜色可以根据P-波幅度上的变化而变化。
在图53中，每个波形176中的P-波1052的峰值幅度以作为时间函数的在ECG迹线1050上的带颜色或带阴影的阴影部分1070来追踪。具体地，在导管插入期间，随着导管组件(例如导管和/或探针)的ECG传感器组件接近SA结或心脏的其他结，连续ECG波形176的P-波1052通常在幅度上变化。通常是有用的是，当这样的变化发生时，在系统显示器30上显示P-波1052的幅度。可以使用线或带颜色的条(bar)来描绘出(trace out)过去峰值的幅度。以这种方式，当前和前一峰值幅度之间的比较可以以常规的方式进行。无论迹线是否跨显示器移动，或者如果该迹线仍为静止且通过横扫(sweep across)所述显示器的移动条被刷新，都可以利用该显示模式。
图54示出一旦P-波1052落到先前的水平之下，如在图54的ECG迹线1050的最左侧部分中可见的，阴影部分1070的另一颜色或阴影可以被用来图示说明最近的峰值与先前峰值之间的不同。可选地，水平线1074可以被用来描绘出如图55中的每个P波1052的峰值。线1074可以在有阴影部分1070或没有阴影部分1070的情况下使用。当然，许多其他这样的追踪实施方式和可视指示可以根据这些原理来设计。
参照图56A-57B，描述例如当被显示在系统显示器30的迹线历史窗口182中时ECG迹线150的缩放控制的许多方面。在典型的ECG装置中，ECG波形显示的速率是恒定的。然而，人们的心跳速率不是恒定的，并且ECG波形形式和间隔因人而异。可能是有利的是，观察者能够改变波形的数目和/或波形被显示在系统显示器30或其他适合的装置上的时间量。这允许更多或更少的ECG波形被显示。在一个实施方案中，临床医生可以调节显示设置以确定有多少ECG波形176被显示，或者所述波形要被显示多长时间。在一个实施方案中，使用者可以从一系列预先限定的分立显示时间或波形选项中进行选择或者所述设置可以是使用者限定的。在另一实施方案中，在ECG迹线1050的显示设置上的控件可以动态地或静态地被系统10自主地控制。
作为上面ECG迹线时间窗口可变性的实施例，图56A示出作为迹线1050的一部分的以四波形的标准速率在所述窗口中被显示的ECG波形176，而图56B示出包括八个波形的增加的ECG迹线窗口。类似地，图57示出以五秒的标准迹线速率被显示的ECG波形数据，即每个波形176保持显示大约五秒；而图57B示出以相对更长的大约10秒的速率(即双倍标准迹线速率)被显示的ECG波形，以致峰值出现的相对更靠近在一起。如图56A-57B所示，ECG迹线窗口的物理宽度保持一致，其中仅有被显示于此的波形的量被修改。
图58示出描绘一方法的一个实施方案的流程图，所述方法用于以上面结合图56A-57B所描述的方式显示ECG信号数据。要注意的是，该方法在整体或部分上可以由系统10的适合的部件(例如被包括在外部传感器50或控制台20中的电路)或者其他适合的导管或医疗设备放置系统来执行。在步骤1080中，在导管放置过程中，ECG信号数据以诸如上面已经结合系统10的使用所描述的方式被采样。在步骤1082中，ECG波形(例如图56A-57B中的波形176)从被采样的ECG信号数据被识别。在步骤1084中，显示窗口(例如用于显示图56A-57B的ECG迹线1050的图17中所示的迹线历史窗口182)的参数被限定。这些参数可以为，例如要被包括在所述窗口中的ECG波形的数目，或每个波形保持在屏幕上的时间量。如步骤1088所示，所述参数可以为使用者限定或自主限定并且以静态(例如在工厂预先设置)或动态(例如通过所述系统根据反馈自主调节)方式被控制。要理解的是，所述参数可以关于ECG迹线或波形的其他显示方面，包括例如波形高度、线宽度等。另外，所述参数可以被限定，以致例如在被刷新之前，零、一、二或者更多个ECG波形被显示在所述迹线窗口中。
在步骤1085中，ECG波形根据所限定的显示窗口参数被显示。如所示，在一个实施方案中，步骤1085可以包括步骤1086和1090。在步骤1086中，如果被步骤1084中限定的参数允许，ECG波形与先前的波形组合。在步骤1090中，当被步骤1084中限定的参数允许时，ECG波形与任何先前的波形一起被显示。
图59示出个别的迹线窗口，如已经被描述的，其中在导管放置过程中，单个ECG波形176被显示并且当新的波形被系统10识别到时被周期性地刷新。例如，如图17示出的显示器屏幕截图178所反映的这样的迹线窗口被用于系统显示器30的当前ECG波形窗口180和窗口184A、184B和184C。如已经被描述的，ECG波形176包括P-波1052和QRS波群1096。P-波1052的峰值大小和QRS波群1096大小之间的比率可以以数值(如图59所示)或其他适合的形式被显示在迹线窗口中，以在导管72被推进通过患者70的脉管系统时辅助临床医生确定ECG波形的变化。在每个新的ECG波形被描绘在个别迹线窗口中时，比率被更新。
图60示出描绘一方法的一个实施方案的流程图，所述方法用于以上面结合图59所描述的方式显示ECG波形。要注意的是，该方法在整体或部分上可以由系统10的适合的部件(例如被包括在外部传感器50或控制台20中的电路)或者其他适合的导管或医疗设备放置系统来执行和/或控制。在步骤1100中，在导管放置过程中，ECG信号数据以上面已经结合系统10的使用所描述的方式被采样。在步骤1102中，ECG波形(例如图59中的波形176)从被采样的ECG信号数据被识别。在步骤1104中，ECG波形176的P-波部分被识别。这可以例如通过比较波形的部分与标准的预先加载的P-波模板以确定P-波1052的存在和位置来实现。
在步骤1106中，P-波幅度的大小和QRS波群幅度1096的大小之间的比率被确定。在一个实施方案中，该步骤可以包括确定P-波的幅度峰值，从ECG波形176识别QRS波群1096以及确定QRS波群大小的大小。在步骤1108中，ECG波形176被显示在诸如系统显示器30(图17)的当前ECG波形窗口180中或窗口184A、184B和184C中的一个中。如果期望的话，波形176可以利用通过步骤1106所获取的P-波/QRS波群比率数据来显示。如图60所示，工序流程可以被重复，以当新的ECG波形被产生并检测时，获取和显示所述新的ECG波形。
步骤1110包括定格图像输出选项，其中使用者可以选择所显示的ECG波形176并将其定格在显示器中，由此中断工序流程的重复，或者可选地防止新获取的波形被显示。再者，在所述工序流程期间可以执行步骤1112，其中与所识别的ECG波形相关的数据被发送到储存位置或装置。如果期望的话，所储存的图像然后可以被显示在诸如系统显示器30(图17)的窗口184A、184B和184C中的一个中。
图61示出出于记录保存/文档的目的可以被打印并使用以检验导管72在患者70的脉管系统内的恰当放置的导管放置记录1114的一个实施例。在一个实施方案中，记录1114可以包括开始ECG波形176A和最终ECG波形176B，开始ECG波形176A表征在导管72被首次引入患者的脉管系统时的ECG波形，最终ECG波形176B表征在所述导管的远侧端被安置在其邻近患者的心脏的期望位置或其他适合的位置时的ECG波形。传感器50的图像表征120可以与被描绘在传感器图像上的探针远侧端图标114一起被包括，以表征所述探针的最终放置位置，并且由此也表征导管的最终放置位置。日期、时间、患者ID等也可以被包括在记录1114中。在一个实施方案中，用于临床医生或责任方签字的地方也可以被包括。在一个实施方案中，记录1114可以为经由系统10是使用者可修改的，从而允许针对各种医院和诊所手术和需求的定制。记录1114的打印输出可以经由被包括在US探测器40、系统控制台20等上的适当的按钮来执行。在另一实施方案中，如果期望的话，图27所示的脚踏开关1116或其他适合的界面可以被用于捕捉和打印记录1114。
图62示出出于记录保存/文档的目的可以被打印并使用以检验导管72的恰当放置的导管放置记录1114的又另一实施例。在一个实施方案中，记录1114可以包括三个窗口，其中每个窗口描绘传感器图像120和选定的末端位置以及ECG波形数据。例如，图62中的记录1114示出左侧窗口、中间窗口以及右侧窗口，所述左侧窗口包括在导管72被首次引入脉管系统时的开始ECG波形176A和相应的ECG迹线1050，所述中间窗口包括修正的ECG迹线1050和在所述导管如探针远侧端图标114所示的被安置时表征ECG波形的中间ECG波形176C，所述右侧窗口包括更新的ECG迹线1050和在所述导管如探针远侧端图标114所示的最终被安置时表征所述ECG波形的最终位置ECG波形176B。当然，其他配置/信息可以被包括在所述记录中。
如本文所述的，通过使用系统10所获取的各种数据可以被储存和/或评估，用于当前或稍后使用。具体地，在一个实施方案中，通过使用系统10所获取的TLS磁性元件追踪数据和ECG信号检测数据二者可以被储存以如本领域技术人员所知晓地使用。在一个实施方案中，针对导管72的TLS磁性元件追踪数据和ECG信号检测数据可以与脉管系统内的导管位置相关联，作为时间的函数，以致导管放置的记录可以实时地被构建或者通过数据的储存被稍后进行。这样的数据在导管放置过程中可以实时地被储存，以在放置期间如果所述系统临时或非预期地关闭时以自动防故障装置模式进行操作。此外，数据在以下方面可以是有用的，即通过计算当前探针远侧末端位置和P-波幅度被最大化的位置之间的距离，相对于ECG信号的峰值P-波幅度正确定位探针位置。数据还可以被用来提供关于这样的路径的三维信息，沿所述路径所述导管在患者脉管系统中被推进。
本发明的实施方案可以包括具有计算机硬件的专用或通用计算机。本公开的范围内的实施方案还包括用于承载或使计算机可执行指令或数据结构储存于其上的计算机可读介质。这样的计算机可读介质可以为可以被通用或专用计算机访问的任何可获得的介质。以实施例的方式而非限制性的，计算机可读介质可以包括物理(或可记录型)计算机可读储存介质，例如RAM、ROM、EEPROM、CD-ROM或其他光盘储存器、磁盘储存器或者其他磁性储存装置、非易失性和闪存存储器，或者可以被用来以计算机可执行指令或数据结构的形式储存期望的程序代码方法并且可以被通用或专用计算机访问的任何其他介质。
在本说明书和所附的权利要求书中，“网络”被限定为在计算机系统和/或模块之间使能电子数据传输的一个或更多个数据链接。当信息在网络或另一通信连接(或者硬连线、无线或者硬连线或无线的组合)上被传输或提供至计算机时，所述计算机恰当地将所述连接视为计算机可读介质。因此，以实施例的方式而不是限制性的，计算机可读介质还可以包括这样的网络或数据链接，所述网络或数据链接可以被用来以计算机可执行指令或数据结构的形式承载或储存期望的程序代码方法并且可以被通用或专用计算机访问。
计算机可执行指令包括，例如导致通用计算机、专用计算机或者专用处理装置执行特定功能或功能组的指令和数据。计算机可执行指令可以为，例如二进制中间格式指令(如汇编语言或者甚至是源代码)。尽管本发明已经在语言上针对结构特征和/或方法动作进行了描述，要理解的是，限定在所附的权利要求书中的本发明无需被限定为所描述的特征或上述动作。相反，所描述的特征和动作被公开为实现权利要求的示例性形式。
本领域技术人员将理解的是，本发明的实施方案可以在具有一种或更多种类型的计算机系统配置(包括个人计算机、桌上型计算机、膝上型计算机、消息处理器、手持装置、多处理器系统、基于微处理器的或可编程的消费性电子产品、上网PC、迷你计算机、主机计算机、移动电话、PDA、寻呼机等等)的计算环境下被实践。实施方案还可以在本地和远程计算机系统(二者都执行任务)通过网络链接(或者通过硬连线的数据链接、无线数据链接或者通过硬连线和无线数据链接的组合)的分布式系统环境下被实践。在分布式系统环境下，程序模块可以位于本地和远程存储器储存装置二者中。
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。

Claims (27)

1.一种用于将导管插入患者的脉管系统的导管放置系统，所述系统包括：
导管组件，所述导管组件包括：
ECG传感器部件，所述ECG传感器部件用于在所述导管组件的至少一部分被放置在所述患者的脉管系统中时，检测所述患者的心脏结的ECG信号；
ECG信号接收部件，所述ECG信号接收部件接收由所述ECG传感器部件检测的ECG信号，所述ECG信号接收部件可操作地可连接到所述ECG传感器部件；以及
连接完整性部件，所述连接完整性部件指示在所述ECG信号接收部件和所述ECG传感器部件之间的可操作的连接。
2.如权利要求1所述的导管放置系统，其中所述导管组件的所述ECG传感器部件包括被包括在可移除地接纳在导管的内腔中的探针上的电极，其中所述ECG传感器部件还包括用于放置在所述患者的皮肤部分上的至少一个外部ECG电极，并且其中所述ECG信号接收部件被设置在所述患者的外部。
3.如权利要求2所述的导管放置系统，其中所述至少一个外部ECG电极包括被安置在用于放置在所述患者的皮肤部分上的单个盘上的第一电极和第二电极。
4.如权利要求2所述的导管放置系统，其中所述至少一个外部ECG电极包括指示所述至少一个外部ECG电极在所述患者的皮肤部分上的适合放置位置的图像。
5.如权利要求1所述的导管放置系统，还包括显示器和被包括在所述显示器上的指示器图标，其中所述指示器图标指示所述ECG信号接收部件和所述ECG传感器部件之间的可操作连接的状态。
6.如权利要求1所述的导管放置系统，其中所述ECG信号接收部件可操作地经由所述ECG信号接收部件与所述ECG传感器部件之间的物理连接是可连接到所述ECG传感器部件的。
7.如权利要求6所述的导管放置系统，其中所述连接完整性部件包括基于阻抗的感测电路、电感感测电路、电容感测电路以及基于电压的电路中的至少一个。
8.如权利要求1所述的导管放置系统，其中所述导管组件的所述ECG传感器部件包括被包括在可移除地接纳在导管的内腔中的探针上的电极，所述探针包括用于检测所述探针是否已经被切断的组件。
9.如权利要求1所述的导管放置系统，其中所述导管组件的所述ECG传感器部件包括被包括在可移除地接纳在导管的内腔中的探针上的电极，所述探针包括用于确保所述探针的远侧端基本上与所述导管的远侧端对齐的系统。
10.如权利要求1所述的导管放置系统，还包括用于在使用期间控制所述导管放置系统功能的一方面的脚踏开关。
11.如权利要求1所述的导管放置系统，其中所述连接完整性部件包括辐射元件，所述辐射元件用于发射在所述ECG传感器部件的至少一条引线上可检测的信号。
12.一种用于在导管放置系统中显示ECG信号数据的方法，其中所述导管放置系统包括导管组件和用于在所述导管组件的导管至少部分地被设置在患者体内时检测所述患者的结的所述ECG信号数据的ECG传感器部件，所述方法包括：
对所述ECG信号数据进行采样；
从所述采样的ECG信号数据识别ECG波形；
限定所述导管放置系统的显示窗口的至少一个参数；以及
根据所述显示窗口的所述至少一个参数，在所述显示窗口中显示所述ECG波形。
13.如权利要求12所述的用于显示的方法，其中显示所述ECG波形的步骤还包括：
当被所述显示窗口的至少一个参数允许时，使所述ECG波形与至少一个先前的ECG波形组合；以及
当被所述显示窗口的所述至少一个参数允许时，在所述显示窗口中显示具有所述至少一个先前的ECG波形的所述ECG波形。
14.如权利要求12所述的用于显示的方法，其中限定所述至少一个参数的步骤还包括：
根据由使用者定义的控件和自主控件中的至少一个限定所述显示窗口的所述至少一个参数。
15.如权利要求12所述的用于显示的方法，其中所述显示窗口被包括在所述导管放置系统的控制台的可视显示器上。
16.如权利要求12所述的用于显示的方法，其中限定所述至少一个参数的步骤还包括：
限定要被包括在所述显示窗口中的ECG波形的数目。
17.如权利要求12所述的用于显示的方法，其中限定所述至少一个参数的步骤还包括：
限定要在所述显示窗口中示出ECG波形的时间量。
18.一种用于在导管放置系统中显示ECG波形的方法，其中所述导管放置系统包括导管组件和用于在所述导管组件的导管至少部分地被设置在患者体内时检测所述患者的结的所述ECG信号数据的ECG传感器部件，所述方法包括：
对所述ECG信号数据进行采样；
从所述采样的ECG信号数据识别ECG波形；
识别与所述ECG波形相关的特征；以及
显示所述ECG波形。
19.如权利要求18所述的用于显示的方法，其中识别所述特征的步骤还包括：
识别所述ECG波形的P-波部分。
20.如权利要求19所述的用于显示的方法，其中识别所述P-波部分的步骤包括比较所述ECG波形的部分与已知的P-波模板。
21.如权利要求18所述的用于显示的方法，其中显示所述ECG波形的步骤还包括：
当显示所述ECG波形时，可视地突出显示所述ECG波形的P-波部分。
22.如权利要求18所述的用于显示的方法，还包括：
识别所述ECG波形的QRS波群；以及
确定所述P-波部分的大小和所述QRS波群的大小之间的比率；以及
利用与所述比率相关的数据显示所述ECG波形。
23.如权利要求18所述的用于显示的方法，还包括：
响应于使用者的输入而在所述导管放置系统的显示器上定格所述ECG波形。
24.如权利要求18所述的用于显示的方法，还包括：
将与所述ECG波形相关的数据储存在储存位置中。
25.如权利要求18所述的用于显示的方法，其中所述方法被循环来显示连续的ECG波形。
26.如权利要求18所述的用于显示的方法，还包括：
响应于所述ECG波形的特征而产生可视或可闻输出。
27.一种计算机程序产品，所述计算机程序产品用于实现储存与使用导管放置系统在患者的脉管系统中放置导管组件的导管相关的信息的方法，所述导管组件包括用于在所述导管至少部分地被设置在所述患者体内时检测患者的结的ECG信号数据的ECG传感器部件，以及产生可由所述导管放置系统检测的磁场或电磁场的磁性元件，所述计算机程序产品包括具有计算机可执行指令储存在一个或更多个计算机可读介质上的所述一个或更多个计算机可读介质，所述计算机可执行指令当被处理器执行时，导致所述计算机系统实现如下内容：
对所述ECG信号数据进行采样；
对所述磁性元件的磁场数据进行采样；
使所述ECG信号数据和所述磁场数据与所述患者体内的所述导管的位置相关联；以及
储存所述相关联的ECG信号数据和磁场数据。
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US9649048B2 (en) 2017-05-16
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US20170231700A1 (en) 2017-08-17
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