CN103750858A - 用于脉管系统内的导管放置的集成系统 - Google Patents

用于脉管系统内的导管放置的集成系统 Download PDF

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CN103750858A
CN103750858A CN201410009216.4A CN201410009216A CN103750858A CN 103750858 A CN103750858 A CN 103750858A CN 201410009216 A CN201410009216 A CN 201410009216A CN 103750858 A CN103750858 A CN 103750858A
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probe
patient
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CN103750858B (zh
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S·梅瑟利
J·B·考克斯
A·K·米森纳
C·C·布莱特
R·R·莱蒙
C·K·克鲁克
M·W·包恩
E·K·伯恩赛德
K·J·克里斯琴
A·欧罗密
J·R·斯塔斯
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Abstract

本发明公开了一种用于脉管系统内的导管放置的集成系统。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。在脉管系统内的所述导管导入之前，所述超声探测器以超声方式成像脉管系统的一部分。所述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所述超声探测器的使用以及在末端定位模式中所述末端定位传感器的使用。在另一实施方案中，基于ECG信号的导管末端引导被包括在所述集成系统中，以使能所述导管末端的引导至一相对于患者的心脏结的期望位置。

Description

用于脉管系统内的导管放置的集成系统
本申请是2010年7月26日递交的申请号为200880125528.4、发明名称为“用于脉管系统内的导管放置的集成系统”的发明专利申请的分案申请。
对相关申请的交叉引用：本申请要求下述申请的优先权：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 IntravascularPlacement of a Catheter）”的美国申请No.12/323,273，以及如下的美国临时专利申请：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 aPatient）”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 AssemblyIncluding 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，本文通过引用将每一个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 thepatient's heart）的期望位置。
在另一个实施方案中，用于在患者的脉管系统中放置导管的集成导管放置系统包括：系统控制台；末端定位传感器，所述末端定位传感器被用来临时放置在所述患者本体的一部分上，所述末端定位传感器被用来在所述导管的远侧部分被设置在所述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，所述末端定位传感器被可操作地连接到所述系统控制台；以及超声探测器，所述超声探测器被用来在所述导管导入所述脉管系统之前以超声方式成像所述患者的内部部分，所述超声探测器被可操作地连接到所述控制台，所述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被用来控制在超声模式中所述超声探测器的使用以及在末端定位模式中所述末端定位传感器的使用。
其中所述系统还包括用来描述与所述超声模式和所述末端定位模式有关的信息的显示器。
其中所述显示器被集成在所述控制台中，并且其中所述控制台包括至少一个控制处理器。
其中所述使用者输入控制装置是包括在所述超声探测器上的按钮。
其中所述超声探测器的所述使用者输入控制装置使能在与所述超声模式有关的信息的描述和与所述末端定位模式有关的信息的描述之间的所述显示器的切换。
其中所述控制台包括使能所述显示器的所述切换的按钮界面。
其中所述探针的磁场是由包括在邻近所述探针的远侧端的至少一个磁元件提供的，所述探针的所述远侧端与所述导管的远侧端基本上是共端头的。
其中所述探针在所述导管放置完成后是从所述导管的所述内腔可移除的。
其中在所述系统的使用期间所述探测器被定位在一无菌区域中，并且其中所述探测器使能临床医生对所述系统的使用而不需要所述临床医生进入到所述无菌区域之外。
其中所述探针的磁场是由包括以下之一的部件产生：永久磁体，电磁体以及前述两者的任何组合。
其中所述的系统还包括ECG末端确认部件，所述ECG末端确认部件用来确定所述导管的远侧末端对所述患者心脏的窦房结的接近度，所述ECG末端确认部件包括：ECG传感器组件，所述ECG传感器组件被包括在所述探针上，用来检测所述窦房结的电活动；以及参考电极和接地电极，所述参考电极和接地电极被用来放置在所述患者的外部部分上，所述ECG传感器组件、参考电极和接地电极经由所述末端定位传感器被可操作地连接到所述系统控制台。
在另一个实施方案中，用于在患者的脉管系统中放置导管的集成导管放置系统包括：控制台，所述控制台包括显示器；超声探测器，所述超声探测器被可操作地连接到所述控制台，所述超声探测器被用来以超声方式成像所述脉管系统的一部分，以在所述显示器上描述；磁组件，所述磁组件与所述导管相关联；以及末端定位传感器，所述末端定位传感器被可操作地连接到所述控制台，所述末端定位传感器被用来在所述显示器上描述与由所述末端定位传感器进行的所述磁组件的磁场检测有关的信息，从而在所述导管在所述脉管系统中推进的过程中相对于所述末端定位传感器确定所述导管的位置。
其中在所述导管的放置过程中，所述末端定位传感器被安置在所述患者的胸部，并且其中所述磁组件与探针一起被包括，所述探针以可移除的方式插入所述导管的内腔，所述探针包括至少一个磁元件。
其中所述至少一个磁元件包括多个铁磁元件。
其中所述至少一个磁元件被包括在所述探针中，从而所述探针与所述导管的远侧末端基本上是共端头的。
其中所述超声探测器包括至少一个使用者输入控制装置以控制所述系统的功能。
在另一个实施方案中，用于在患者的脉管系统中放置导管的方法包括：以超声方式成像所述脉管系统的一部分，以在控制台的显示器上描述；将所述导管导入所述患者的所述脉管系统，所述导管包括与所述导管相关联的磁组件；以及当所述导管在所述患者的所述脉管系统中时，检测所述磁组件的磁场以在所述控制台的所述显示器上描述。
其中所述用于放置的方法还包括：控制以超声方式成像并且检测磁场的步骤而不用到所述患者的无菌区域之外。
其中所述用于放置的方法，还包括：当所述导管在所述患者的所述脉管系统中时，通过与所述导管相关联的ECG传感器组件检测所述患者心脏结的ECG信号，以在所述控制台的所述显示器上描述。
其中所述用于放置的方法，还包括：控制检测所述ECG信号的步骤而不用到所述患者的无菌区域之外。
其中所述用于放置的方法，还包括：选择性地显示经由被可操作地连接到所述控制台的超声探测器通过使用者输入进行的与以超声方式成像、检测磁场以及检测所述ECG信号的所述步骤有关的信息。
在另一个实施方案中，用于将导管插入患者的脉管系统的导管放置系统包括：控制台；探针，所述探针以可移除的方式可安置在所述导管的内腔中，所述探针包括：磁组件，所述磁组件用于产生磁场；ECG传感器组件，所述ECG传感器组件用于检测所述患者心脏结的ECG信号；以及第一连接器，所述第一连接器与所述ECG传感器组件连通；末端定位传感器，所述末端定位传感器可安置在患者胸部，所述末端定位传感器被配置来当所述导管被设置在所述患者的所述脉管系统中时检测所述磁组件的磁场；第二连接器，所述第二连接器与所述末端定位传感器和所述控制台中的一个一起被包括，所述第二连接器用于可操作地连接到所述探针的所述第一连接器，以使由所述ECG传感器组件检测的所述ECG信号能够被发送到所述末端定位传感器和所述控制台中的至少一个；以及显示器，所述显示器用于显示与由所述ECG传感器组件检测的所述ECG信号中的至少一个方面有关的信息。
其中当所述导管的远侧末端被安置在一相对于心脏结的预先确定的位置时，所述控制台显示器使临床医生能够确定。
其中所述第二连接器与所述末端定位传感器一起被包括，并且其中所述第一和第二连接器经由被限定在布单上的穿孔被物理连接，所述布单被放置在所述探针和安置在所述患者胸部上的所述末端定位传感器之间，所述第一和第二连接器的所述物理连接在所述布单中产生所述穿孔并且限制所述穿孔，从而防止损害所述患者的无菌区域。
其中所述ECG传感器组件包括所述探针的导电性芯线，所述芯线与所述第一连接器可操作地连通。
其中所述芯线包括向远侧渐缩的部分，所述芯线延伸至所述探针的远侧端。
其中所述第一连接器包括与所述芯线可操作地连通的针触头，所述针触头设置在被限定在所述第一连接器内的凹槽中。
其中所述第二连接器为与所述末端定位传感器一起被包括的鳍状连接器，所述第一连接器是以可滑动的方式可附接到所述第二连接器，以致所述第一连接器的所述针触头被放置来与所述第二连接器的触头可操作地连通，以使ECG信号能够从所述ECG传感器组件传输至所述末端定位传感器。
其中所述第二连接器为选择性地从所述末端定位传感器可移除的鳍状传感器。
其中所述末端定位传感器包括以可滑动的方式接纳所述鳍状连接器的筒形部分的凹槽，以致所述末端定位传感器的至少一个电气触头被放置来与所述鳍状连接器的至少一个电气触头连通。
其中所述磁组件包括多个被邻近所述探针的远端安置的磁元件，所述探针被设置在所述导管的所述内腔中，以致所述多个磁元件基本上是邻近所述导管的远侧末端的。
其中所述系统还包括超声探测器，所述超声探测器可操作地与所述控制台连接，用于在所述导管导入所述脉管系统之前以超声方式成像所述脉管系统的一部分，以在所述显示器上描述。
其中所述显示器在第一模式中描述与由所述超声探测器以超声方式成像有关的各方面，其中所述显示器在第二模式中描述与由所述末端定位传感器进行的所述磁组件的磁场的探测有关的各方面，其中所述显示器在第三模式中描述与由所述ECG的所述ECG传感器组件进行的探测有关的各方面，并且其中所述临床医生不用到所述患者的无菌区域之外即可对由所述显示器所描述的所述模式进行选择。
其中所述显示器在所述第三模式中显示所述患者的所述心脏结的当前ECG迹线。
其中所述显示器在所述第二模式中描绘第一图标以指示所述磁组件对所述末端定位传感器的第一接近度，以及第二图标以指示所述磁组件对所述末端定位传感器的第二接近度。
其中所述探针和所述第二连接器在一次使用后是可抛弃的。
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组件的各种视图；
图14A-14C为示出探针绳缆（tether）与鳍状连接器（fin connector）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；以及
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。
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1-17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。
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（MedicalInstrument 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 andMethods 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，并且可以被一同使用或单独使用来帮助放置导管。
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）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文本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上，以与在绳缆连接器132上的相对应的接合件接合，来帮助保持在这两个部件之间的配接（mating）。
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。
图14B示出第一连接阶段，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。
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。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。
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被配置来以这样的方式配接传感器底部触头154，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。
图16示出包括P-波和QRS波群的典型的ECG波形176。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以及在通行穿过患者脉管系统期间可以对应于探针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。
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 (36)

1.一种用于在患者的脉管系统中放置导管的集成导管放置系统，所述系统包括：
系统控制台；
末端定位传感器，所述末端定位传感器被用来临时放置在所述患者本体的一部分上，所述末端定位传感器被用来在所述导管的远侧部分被设置在所述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，所述末端定位传感器被可操作地连接到所述系统控制台；以及
超声探测器，所述超声探测器被用来在所述导管导入所述脉管系统之前以超声方式成像所述患者的内部部分，所述超声探测器被可操作地连接到所述控制台，所述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被用来控制在超声模式中所述超声探测器的使用以及在末端定位模式中所述末端定位传感器的使用。
2.如权利要求1所述的系统，还包括用来描述与所述超声模式和所述末端定位模式有关的信息的显示器。
3.如权利要求2所述的系统，其中所述显示器被集成在所述控制台中，并且其中所述控制台包括至少一个控制处理器。
4.如权利要求1所述的系统，其中所述使用者输入控制装置是包括在所述超声探测器上的按钮。
5.如权利要求1所述的系统，其中所述超声探测器的所述使用者输入控制装置使能在与所述超声模式有关的信息的描述和与所述末端定位模式有关的信息的描述之间的所述显示器的切换。
6.如权利要求5所述的系统，其中所述控制台包括使能所述显示器的所述切换的按钮界面。
7.如权利要求1所述的系统，其中所述探针的磁场是由包括在邻近所述探针的远侧端的至少一个磁元件提供的，所述探针的所述远侧端与所述导管的远侧端基本上是共端头的。
8.如权利要求1所述的系统，其中所述探针在所述导管放置完成后是从所述导管的所述内腔可移除的。
9.如权利要求1所述的系统，其中在所述系统的使用期间所述探测器被定位在一无菌区域中，并且其中所述探测器使能临床医生对所述系统的使用而不需要所述临床医生进入到所述无菌区域之外。
10.如权利要求1所述的系统，其中所述探针的磁场是由包括以下之一的部件产生：永久磁体，电磁体以及前述两者的任何组合。
11.如权利要求1所述的系统，还包括ECG末端确认部件，所述ECG末端确认部件用来确定所述导管的远侧末端对所述患者心脏的窦房结的接近度，所述ECG末端确认部件包括：
ECG传感器组件，所述ECG传感器组件被包括在所述探针上，用来检测所述窦房结的电活动；以及
参考电极和接地电极，所述参考电极和接地电极被用来放置在所述患者的外部部分上，所述ECG传感器组件、参考电极和接地电极经由所述末端定位传感器被可操作地连接到所述系统控制台。
12.一种用于在患者的脉管系统中放置导管的集成导管放置系统，所述系统包括：
控制台，所述控制台包括显示器；
超声探测器，所述超声探测器被可操作地连接到所述控制台，所述超声探测器被用来以超声方式成像所述脉管系统的一部分，以在所述显示器上描述；
磁组件，所述磁组件与所述导管相关联；以及
末端定位传感器，所述末端定位传感器被可操作地连接到所述控制台，所述末端定位传感器被用来在所述显示器上描述与由所述末端定位传感器进行的所述磁组件的磁场检测有关的信息，从而在所述导管在所述脉管系统中推进的过程中相对于所述末端定位传感器确定所述导管的位置。
13.如权利要求12所述的系统，其中在所述导管的放置过程中，所述末端定位传感器被安置在所述患者的胸部，并且其中所述磁组件与探针一起被包括，所述探针以可移除的方式插入所述导管的内腔，所述探针包括至少一个磁元件。
14.如权利要求13所述的系统，其中所述至少一个磁元件包括多个铁磁元件。
15.如权利要求14所述的系统，其中所述至少一个磁元件被包括在所述探针中，从而所述探针与所述导管的远侧末端基本上是共端头的。
16.如权利要求12所述的系统，其中所述超声探测器包括至少一个使用者输入控制装置以控制所述系统的功能。
17.一种用于在患者的脉管系统中放置导管的方法，所述方法包括：
以超声方式成像所述脉管系统的一部分，以在控制台的显示器上描述；
将所述导管导入所述患者的所述脉管系统，所述导管包括与所述导管相关联的磁组件；以及
当所述导管在所述患者的所述脉管系统中时，检测所述磁组件的磁场以在所述控制台的所述显示器上描述。
18.如权利要求17所述的用于放置的方法，还包括：
控制以超声方式成像并且检测磁场的步骤而不用到所述患者的无菌区域之外。
19.如权利要求18所述的用于放置的方法，还包括：
当所述导管在所述患者的所述脉管系统中时，通过与所述导管相关联的ECG传感器组件检测所述患者心脏结的ECG信号，以在所述控制台的所述显示器上描述。
20.如权利要求19所述的用于放置的方法，还包括：
控制检测所述ECG信号的步骤而不用到所述患者的无菌区域之外。
21.如权利要求20所述的用于放置的方法，还包括：
选择性地显示经由被可操作地连接到所述控制台的超声探测器通过使用者输入进行的与以超声方式成像、检测磁场以及检测所述ECG信号的所述步骤有关的信息。
22.一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：
控制台；
探针，所述探针以可移除的方式可安置在所述导管的内腔中，所述探针包括：
磁组件，所述磁组件用于产生磁场；
ECG传感器组件，所述ECG传感器组件用于检测所述患者心脏结的ECG信号；以及
第一连接器，所述第一连接器与所述ECG传感器组件连通；
末端定位传感器，所述末端定位传感器可安置在患者胸部，所述末端定位传感器被配置来当所述导管被设置在所述患者的所述脉管系统中时检测所述磁组件的磁场；
第二连接器，所述第二连接器与所述末端定位传感器和所述控制台中的一个一起被包括，所述第二连接器用于可操作地连接到所述探针的所述第一连接器，以使由所述ECG传感器组件检测的所述ECG信号能够被发送到所述末端定位传感器和所述控制台中的至少一个；以及
显示器，所述显示器用于显示与由所述ECG传感器组件检测的所述ECG信号中的至少一个方面有关的信息。
23.如权利要求22所述的系统，其中当所述导管的远侧末端被安置在一相对于心脏结的预先确定的位置时，所述控制台显示器使临床医生能够确定。
24.如权利要求22所述的系统，其中所述第二连接器与所述末端定位传感器一起被包括，并且其中所述第一和第二连接器经由被限定在布单上的穿孔被物理连接，所述布单被放置在所述探针和安置在所述患者胸部上的所述末端定位传感器之间，所述第一和第二连接器的所述物理连接在所述布单中产生所述穿孔并且限制所述穿孔，从而防止损害所述患者的无菌区域。
25.如权利要求24所述的系统，其中所述ECG传感器组件包括所述探针的导电性芯线，所述芯线与所述第一连接器可操作地连通。
26.如权利要求25所述的系统，其中所述芯线包括向远侧渐缩的部分，所述芯线延伸至所述探针的远侧端。
27.如权利要求25所述的系统，其中所述第一连接器包括与所述芯线可操作地连通的针触头，所述针触头设置在被限定在所述第一连接器内的凹槽中。
28.如权利要求27所述的系统，其中所述第二连接器为与所述末端定位传感器一起被包括的鳍状连接器，所述第一连接器是以可滑动的方式可附接到所述第二连接器，以致所述第一连接器的所述针触头被放置来与所述第二连接器的触头可操作地连通，以使ECG信号能够从所述ECG传感器组件传输至所述末端定位传感器。
29.如权利要求28所述的系统，其中所述第二连接器为选择性地从所述末端定位传感器可移除的鳍状传感器。
30.如权利要求29所述的系统，其中所述末端定位传感器包括以可滑动的方式接纳所述鳍状连接器的筒形部分的凹槽，以致所述末端定位传感器的至少一个电气触头被放置来与所述鳍状连接器的至少一个电气触头连通。
31.如权利要求22所述的系统，其中所述磁组件包括多个被邻近所述探针的远端安置的磁元件，所述探针被设置在所述导管的所述内腔中，以致所述多个磁元件基本上是邻近所述导管的远侧末端的。
32.如权利要求22所述的系统，还包括超声探测器，所述超声探测器可操作地与所述控制台连接，用于在所述导管导入所述脉管系统之前以超声方式成像所述脉管系统的一部分，以在所述显示器上描述。
33.如权利要求32所述的系统，其中所述显示器在第一模式中描述与由所述超声探测器以超声方式成像有关的各方面，其中所述显示器在第二模式中描述与由所述末端定位传感器进行的所述磁组件的磁场的探测有关的各方面，其中所述显示器在第三模式中描述与由所述ECG的所述ECG传感器组件进行的探测有关的各方面，并且其中所述临床医生不用到所述患者的无菌区域之外即可对由所述显示器所描述的所述模式进行选择。
34.如权利要求33所述的系统，其中所述显示器在所述第三模式中显示所述患者的所述心脏结的当前ECG迹线。
35.如权利要求22所述的系统，其中所述显示器在所述第二模式中描绘第一图标以指示所述磁组件对所述末端定位传感器的第一接近度，以及第二图标以指示所述磁组件对所述末端定位传感器的第二接近度。
36.如权利要求22所述的系统，其中所述探针和所述第二连接器在一次使用后是可抛弃的。
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