CN102821679B - 用于导管导航和末端定位的装置和方法 - Google Patents

用于导管导航和末端定位的装置和方法 Download PDF

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CN102821679B
CN102821679B CN201180016462.7A CN201180016462A CN102821679B CN 102821679 B CN102821679 B CN 102821679B CN 201180016462 A CN201180016462 A CN 201180016462A CN 102821679 B CN102821679 B CN 102821679B
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S·格伦沃尔德
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Abstract

公开了用于在许多临床应用和设置中获得和使用血管内的电图的设备和方法。在一个实施方案中，为确定诸如导管的留置医疗设备的定位，公开了用于基于以基于皮肤的ECG波形中的峰检测来触发血管内的ECG波形的分析的方法。在另一实施方案中，脉管系统中导管或其他医疗设备的位置可以通过被检测到的P波的能量分布的分析来确定。在另外的其他实施方案中，公开了用于建立一穿过无菌区的可操作连接的磁性连接设备。

Description

用于导管导航和末端定位的装置和方法
相关申请的交叉引用：本申请是2010年8月10日递交的美国专利申请No.12/854,083的部分继续申请，该申请No.12/854,083是2010年6月14日递交的美国专利申请No.12/815,331的部分继续申请，该申请No.12/815,331要求2009年6月12日递交的美国临时专利申请No.61/213,474的优先权，这些专利申请的公开内容通过引用被整体并入本文。本申请还要求2010年2月2日递交的美国临时专利申请No.61/282,397的优先权，该临时专利申请的公开内容通过引用被整体并入本文。
背景技术
心脏的导电系统创建特定的电信号，这些电信号的电能分布和行为指示胸腔内的特定位置和/或特定心脏机能或症状。当在血管内测量时，即，从血管内或者从心脏内测量时，心脏的电活动的某些参数可以用于识别心血管系统中的特定位置和/或正常或异常的机能症状。而且，通过局部地且精确地识别症状的位置和类型，可以优化这样的症状的治疗，并且可以实时地监控治疗效果。
通常解决了两种类型的临床应用。第一种涉及引导血管内设备穿过心血管系统，而第二种涉及心脏的电活动的无创或微创远程监控。
血管内导管的引导、定位和放置确认在许多临床应用中是有必要的，所述临床应用例如：
1.中心静脉进入，比如，CVC、PICC、可植入端口；
2.血液透析导管；
3.起搏器引线的放置；
4.血液动力学监控导管，比如，Swan-Ganz和中心压力监控导管；以及
5.将导丝和导管引导到左心中。
导管末端的位置对于患者的安全、手术的持续时间和手术的成功是非常重要的。如今的用于确认导管末端的目标位置的金标准是胸部X射线。另外，目前市场上可以买到设法克服胸部X射线确认的限制的两种类型的实时引导产品：电磁的和基于ECG的。在使用实时引导的医院中，就减少X射线的数量、手术时间和手术成本而言，结果有所改进。在实时引导下，首次成功率通常从75％-80％提高到90％-95％。另外，在比如意大利、比利时、德国的使用ECG引导的医院中，对于超过90％的患者已经省去了胸部X射线确认。美国主要使用电磁系统，而欧洲主要使用基于ECG的系统。在就技术采用而言确定美国市场与欧洲市场之间的差异的其他因素之中：a)被允许执行手术的医护人员的类型：在美国，护士具有更大的灵活性；b)所放置的设备的类型：在美国越来越频繁地放置PICC；c)价格敏感性：欧洲市场似乎对价格更敏感；以及d)特定制造商将目前的引导设备商业化为仅与他们的导管一起工作：引导系统的市场渗透率反映了导管制造商的市场渗透率。
还发现，关于目标末端位置应该所处的地方存在不同的意见：例如，SVC的下三分之一处或RA。因此，引导技术应该顾及区分这些位置。作为目前的金标准的胸部X射线不总是顾及这样的区分，这样的区分要求通常好于2cm的精度。此外，由于基于ECG的系统使用与心脏活动相关的生理信息，所以它们引导放置的能力对于解剖来说是精确的。就测量脉管系统中的导管末端与通常放置在患者胸部上的外部参考之间的距离的电磁引导系统而言，情况不是这样。由于这个方面，基于ECG的系统可以用于记载导管放置的最终结果，这可能取代胸部X射线作为金标准。
可利用的最有价值的诊断工具之一，ECG将心脏的电活动记录为波形。通过解释这些波形，可以识别节律紊乱、传导异常和电介质失衡。ECG辅助诊断和监控诸如急性冠脉综合征和心包炎这样的症状。心脏的电活动生成辐射穿过周围组织到达皮肤的电流。当电极附接到皮肤时，它们感测这些电流，并且将它们发送到心电图仪。由于来自心脏的电流在许多方向上辐射到皮肤，所以电极被放置在皮肤上的不同位置处，以获得心脏的电活动的总状况(totalpicture)。电极然后与心电图仪设备或计算机连接，并且记录来自不同测试方法(perspective)的信息，所述不同测试方法被称为导联(lead)和平面。导联提供在两个点或极之间的心脏电活动的视图。平面是提供心脏的电活动的不同视图的心脏截面图。目前，ECG波形的解释基于识别波形分量幅值、分析这些幅值、然后将这些幅值与某些标准进行比较。这些幅值分量的改变指示某些症状(比如，ST段升高)或者指示心脏中的某些位置(比如，P波(P-波)的幅值)。在如今的实践中，ECG监控器广泛用于记录ECG波形。越来越平常的应用可供用于ECG幅值分量的自动识别。在某些情况下，可利用用于决策制定支持和用于对于基本心脏病的ECG幅值分量的自动解释的工具。
远程患者监控是完善的医学领域。但是，心脏病的远程监控没有如它预期所需要的和可能的那样被广泛接受。原因之一涉及获取与心脏活动相关的信号(具体地，ECG信号)的方式相对复杂。目前远程监控技术的另一个重要限制因素是使用在患者端和医生端这二者都难以通过接口连接的通信信道，比如，电话线。
发明内容
简要概述，本发明的实施方案涉及用于在许多临床应用和设置中获得和使用血管内的电图(或者心电图/ECG)的系统、设备和方法。例如，设备可以被用于在心脏内部和周围导引血管内的设备，例如在上腔静脉、右心房和右心室内导引中心静脉进入设备。这样的中心静脉进入设备可以包括中心静脉导管(CVC)、外周置入中心导管(PICC)、可植入端口、血液透析导管、隧道式导管以及其他设备。
在一方面，在通过使用血管内的(腔内的)电极获取血管内的(腔内的)电图(ECG)信号的同时，一个或数个皮肤电极被用来获得皮肤表面ECG信号。以数种方式中的一种使用同时且同步的皮肤表面和血管内的ECG信号，来根据血管内的电极(例如，根据导管的末端)的定位分析和量化ECG信号。
鉴于上述，在一个实施方案中，基于ECG的导管导航和末端定位的易用性被加强。在一个方面，例如皮肤ECG参考波形与在导管或其他留置医疗设备的末端处测量的血管内的ECG波形被同时呈现在显示器上。这样的并发ECG信号的同时获取和显示允许在导管末端处的血管内的ECG波形的即时解释(readyinterpretation)。在另一方面，皮肤ECG参考信号被用来同步应用于血管内的ECG信号的信息处理算法，产生关于血管内的ECG信号的P波在波形和能量上的变化的增强可靠性的结果。
更具体地，在一个实施方案中，皮肤ECG信号可以被用作参考并且可以与血管内的ECG信号比较，以便检测血管内的ECG相对于皮肤ECG的变化。
在另一实施方案中，同步的皮肤和/或血管内的ECG信号的分析可以被相互关联和/或关联到心脏的周期性电活动。例如，皮肤ECG导联(ECGlead)可以用来检测被检测到的皮肤ECG波形的QRS复合波的R峰(R-峰)。皮肤ECG波形中的R峰的检测可以用来触发血管内的ECG波形的同步相应段(例如，与P波相应的段)中的血管内的ECG信号的分析。这样的触发对心律失常的情况是尤为有用的，在心律失常的情况下皮肤ECG波形通常不会示出一致的P波，而血管内的ECG波形的确包括根据脉管系统中的部位而变化的可检测的P波段。
在另一实施方案中，皮肤ECG导联可以用来监控患者的心脏活动，同时血管内的ECG导联用来导引导管或其他适合的留置或血管内的设备通过脉管系统。在另一实施方案中，皮肤ECG波形中被检测到的R峰用来触发对血管内的ECG信号的相关的计算和其他类型的信号处理，从而允许所得血管内的ECG波形中的有效噪声减少。
在另一方面，用于在患者的无菌区中的导管与无菌区之外的ECG线缆之间建立可操作连接的连接器被描述，允许单个操作者使用本文所介绍的用于导管导航和末端定位的设备。
在另一方面，算法被介绍，允许将特定ECG波形映射到脉管系统中的相应部位。在一个实施方案中，算法分析能够检测血管内的ECG信号的导管或其他血管内的设备的末端处出现的方向性电能。在另一实施方案中，该算法可以基于血管内的ECG信号将导管末端映射到脉管系统中的特定部位，从而允许导管导航。
在另一方面，公开了简化的图形用户界面，在心脏图标上描绘移动的图形指示符，从而如由血管内的ECG信号所确定的，指示导管末端在脉管系统中的定位。图形指示符可以包括不同的颜色和形状，例如，举例说明，点形或箭形。图形指示符的颜色和形状可以根据末端在脉管系统中的定位而改变。
在另一方面，公开了ECG信号获取模块，该ECG信号获取模块通过适合的接口可操作地可连接到移动电话或其他便携式电子设备。这使得移动电话的使用者能够进行包括ECG信号分析在内的ECG信号获取模块的控制。在另一实施方案中，ECG信号获取模块可以可操作地接口连接到其他手持或远程设备。
在另一方面，用户界面被包括来与移动电话或其他便携式设备结合使用，以使能通过移动电话进行的血管内的设备的基于ECG信号的导引。在另一实施方案中，用户界面使得移动电话的使用能够支持ECG信号、导管信息以及导管放置过程的结果的分析和归档。在另一实施方案中，用户界面优化针对远程患者通过移动电话或其他手持设备进行监控的ECG信号获取。
由此，已经相当概括地概述了本发明的某些实施方案，以便可以更好地理解本文中其详细描述，并且以便可以更好地领会对本领域所作的贡献。当然，存在将在以下描述的和将形成所附权利要求的主题的本发明的另外的实施方案。
在这个方面，在对本发明的至少一个实施方案进行详细说明之前，要理解，各实施方案在其应用中不限于以下描述所阐述的或者附图中所图示说明的构造的细节和组件的布置。的确，除了本文所描述的实施方案之外的其他实施方案可以以各种方式被设想、实施和实现。此外，要理解，本文和摘要所用的措词和术语是为了描述的目的，而不应该被认为是限制性的。
就这点而论，本领域技术人员将意识到，本公开内容所基于的概念可以容易地被用作用于设计实现本发明的实施方案的数种目的的其他结构、方法和系统的基础。因此，重要的是，认为权利要求包括这样的等同构造，只要它们不脱离本公开的精神和范围。
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1A是描绘根据本发明的实施方案的仪器的框图。
图1B是根据本发明的实施方案的用于获取和处理血管内心电图的电子模块的框图。
图2描绘根据本发明的实施方案的用于血管内的设备的适配器。
图3描绘根据本发明的实施方案的导管操控设备。
图4A、图4B、图4C和图4D描绘根据本发明的各个实施方案提供血管内心电图的最佳获取的电极构造。图4A描绘单导联构造，图4B描绘具有监控和引导能力的改进的3导联构造，图4C描绘具有单接地导联的遥测构造，以及图4D描绘用于引导血管内设备的ECG监控器的一种用法。
图5图示说明中心静脉系统中的不同位置处的示例性心电图信号幅值。
图6图示说明中心静脉系统中的不同位置处的示例性心电图信号功率谱。
图7图示说明中心静脉系统中的不同位置处的示例性心电图信号电能分布。
图8描绘根据本发明的实施方案的图形用户界面。
图9描绘根据本发明的另一个实施方案的图形用户界面。
图10A和图10B描绘根据本发明的实施方案的图形用户界面所显示的信息的示例性打印输出。
图11是用于使用心电图信号将血管内设备定位在心脏的内部或附近的基于计算机方法的框图。
图12图示说明根据一个实施方案的用于使用心电图信号将血管内设备定位在心脏的内部或附近的基于计算机的方法的另一种决策支持算法。
图13图示说明心脏的心脏传导系统。
图14图示说明心脏的传导系统中的电信号传播。
图15图示说明由于神经元控制系统而导致的心血管系统中的电活动。
图16图示说明根据本发明的实施方案的用于分析血管内的电图信号的架构。
图17图示说明用于电图波形处理的数个实施方案。
图18A示出被安置来形成爱氏三角(Einthoventriangle)的ECG导联。
图18B-图18F示出根据一个实施方案的如图形用户界面上所描绘的皮肤ECG波形和血管内的ECG波形的各种视图。
图19A和图19B示出根据一个实施方案的如图形用户界面上所描绘的皮肤ECG波形和血管内的ECG波形的各种视图。
图20A和图20F示出根据一个实施方案的如图形用户界面上所描绘的皮肤ECG波形和血管内的ECG波形的各种视图。
图21A和图21B示出根据一个实施方案的如图形用户界面上所描绘的皮肤ECG波形和血管内的ECG波形的各种视图。
图22A-图22D示出根据特定实施方案的各种磁性无菌连接器。
图23A和图23B示出根据特定实施方案的各种可操控的无菌连接器。
图24A-图24F示出根据一个实施方案的如图形用户界面上所描绘的皮肤ECG波形和血管内的ECG波形以及心脏图标的各种视图，以指示血管内的设备的位置。
图25A和图25B示出根据一个实施方案的如移动电话上所显示的用于在基于ECG信号导引中使用的各种可能的示图。
图26示出根据一个实施方案的如移动电话上所显示的多个ECG波形的缩放示图。
图27A和图27B示出根据一个实施方案的如移动电话上所显示的附加的ECG波形的相关示图。
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。
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。
本发明的实施方案有利地提供用于在许多临床应用和设置中获得并使用血管内ECG的具有创造性的仪器(一个或多个)、基于计算机的数据处理算法和方法。例如，设备可以用于将血管内设备引导到心脏的内部及周围，比如，在上腔静脉、右心房和右心室中引导中心静脉进入设备。这样的中心静脉进入设备可以包括中心静脉导管(CVC)、外周置入中心导管(PICC)、可植入端口、血液透析导管、隧道式导管和其他设备。可以从利用具有创造性的仪器进行引导受益的其他设备是遍布中心静脉系统放置的临时起搏器引线。通过减小将这些设备引导到适当位置所需的对比度和辐射的量，左心手术中所使用的导管和导丝也可以从本文所公开的实施方案受益。在另一个实施例中，所述仪器可以用于微创监控心脏病和基于其电活动来评估心脏病，比如，评估心搏周期中的前负荷，或者监控充血性心力衰竭中的ST段和T波(T-波)。
在一方面，描述由无菌适配器、用于信号获取的电子模块、计算机模块、软件以及外围设备和连接构成的仪器。在一个实施方案中，用于信号获取的电子模块可以专用于获取并处理由身体产生的血管内电信号(血管内ECG)，在另一个实施方案中，电子模块可以专用于获取并处理血管内ECG以及皮肤ECG。
在一个实施方案中，电子模块和计算机模块可以是分离的模块，在另一个实施方案中，它们可以集成在同一模块和外壳中，然而，在另一个实施方案中，它们可以通过诸如蓝牙的无线连接彼此通信。在一个实施方案中，所述仪器可以包含集成的打印机，而在另一个实施方案中，打印机可以是在外部，并且附接到所述仪器，所述仪器通过比如无线的网络与其他设备连接。在又一个实施方案中，所述仪器可以用于遥测和用于将血管内心电图发送到远程位置，比如，通过电话线、互联网和/或无线电话。以上提及的实施方案的任何组合也是可以的。
在另一方面，各种构造使得可将诸如中心静脉进入设备的血管内设备与用于信号获取和处理的电子模块连接。在一个实施方案中，所述设备由具有两个端部的连接线和在每个端部的特定连接器构成。在一个端部，所述线可以与通常可以在市场上买到的金属或镍钛诺导丝或者探针连接。在另一个端部，所述线可以与电子模块安全地连接。在另一个实施方案中，所述设备包括比如由镍钛诺或不锈钢制成的、具有无覆层的远侧端和近侧端以及厘米标记(cmmarking)的覆层导丝。在这样的实施方案中，在连接线与覆层导丝的近侧端连接时，覆层导丝被血管内地插入。在另一个实施方案中，所述设备包括设有电连接线的导管-注射器适配器。在一个端部，电连接线与流体接触，所述流体比如是在导管-注射器适配器内流动的含盐液((saline))。在另一个端部，连接线可以与电子模块连接。
在另一方面，各种电极构造顾及血管内ECG的最佳获取。在一个实施方案中，单导联用于提供关于血管内设备在脉管系统内的末端位置的信息。在另一个实施方案中，改进的三导联构造用于提供心脏活动的同时3导联监控，同时提供末端位置信息。在另一个实施方案中，改进的单导联构造加上地(ground)用于遥测和远程地传送来自导管末端的信息。
在另一方面，介绍用于分析ECG波形和用于基于这些波形支持决策制定的算法。这些算法区分脉管系统中的不同位置，并且评估身体机能(全身的和身体中的特定位置处的)，特别是心脏机能。在各个实施方案中，这些算法使用波形的时域分析：形态学，例如形状；统计学，例如行为。
在其他实施方案中，所述算法使用波形的频域分析：形态学，例如形状；统计学，例如行为。在进一步的实施方案中，还执行时域和频域中的形态的和统计的信号能量分析。本实施方案还设想模糊、统计和基于知识的决策制定作为决策支持工具。
在另一方面，提供有利地简化数据和工作流的解释的用户界面。在一个实施方案中，所述用户界面包括简化图形，这些简化图形示出所使用的血管内设备的末端在脉管系统和心脏中的位置，而不显示ECG波形中的任何一个。在另一个实施方案中，所述用户界面实时地示出所使用的血管内设备的末端的位置的改变。
在另一方面，提供了在临床应用中使用本文所述的仪器的几种具有创造性的方法。在一个实施方案中，提供以下基于计算机的方法，该方法使用探针、导丝和盐溶液将中心静脉导管(CVC、PICC、血液透析、可植入端口及其他)引导到上腔静脉、下腔静脉、右心房和右心室。该方法优于现有技术之处在于对心律失常的患者不是那么敏感，并且作为大多数临床情况下的中心静脉导管的末端位置的胸部X射线确认的可替换方案。在另一个实施方案中，提供在右心和左心中引导覆层导丝的基于计算机的方法。在另一个实施方案中，提供引导临时起搏器引线穿过中心静脉系统的放置的基于计算机的方法。在另一个实施方案中，提供微创的、使用去极化(depolarization)和心律监控前负荷的方法。在另一个实施方案中，提供微创的、使用P波分析监控心律失常的方法。在另一个实施方案中，提供微创的、使用ST段和T波分析监控心力衰竭的方法。
在一方面，在通过使用血管内的(腔内的)电极获取血管内的(腔内的)电图(ECG)信号的同时，一个或数个皮肤电极被用来获得皮肤表面ECG信号。以数种方式中的一种使用同时且同步的皮肤表面和血管内的ECG信号，来根据血管内的电极(例如，根据导管的末端)的定位分析和量化ECG信号。
鉴于上述，在一个实施方案中，基于ECG的导管导航和末端定位的易用性被加强。在一个方面，例如皮肤ECG参考波形与在导管或其他留置医疗设备的末端处测量的血管内的ECG波形被同时呈现在显示器上。这样的并发ECG信号的同时获取和显示允许在导管末端处的血管内的ECG波形的即时解释。在另一方面，皮肤ECG参考信号被用来同步应用于血管内的ECG信号的信息处理算法，产生关于血管内的ECG信号的P波在波形和能量上的变化的增强可靠性的结果。
在另一实施方案中，同步的皮肤和/或血管内的ECG信号的分析可以被相互关联和/或关联到心脏的周期性电活动。例如，皮肤ECG导联可以用来检测被检测到的皮肤ECG波形的QRS复合波的R峰。皮肤ECG波形中的R峰的检测可以用来触发血管内的ECG波形的同步相应段(例如，与P波相应的段)中的血管内的ECG信号的分析。这样的触发对心律失常的情况是尤为有用的，在心律失常的情况下皮肤ECG波形通常不会示出一致的P波，而血管内的ECG波形的确包括根据脉管系统中的部位而变化的可检测的P波段。
在其他实施方案中，公开了磁性的且可操控的无菌连接器，并且公开了用于使得移动电话或其他手持设备能够控制基于ECG的系统的显示和控制方案的各方面(包括上述各方面中的一个或更多个)。
图1A是描绘根据本发明的实施方案的仪器的框图。
仪器100可以通过适配器(120)附接到大量市售的、定制设计的血管进入设备(110)。这样的设备的示例有：中心静脉导管(CVC)、外周置入中心导管(PICC)、可植入端口、隧道式导管、血液透析导管、用于起搏器引线的引导导管、用于冠状动脉和其他血管介入的导丝、用于冠状动脉和其他血管介入的引导导管、探针、注射器针头及其他。如果脉管进入设备是探针、导丝或注射器针头，则它的材料必须充分导电，比如，不锈钢或镍钛诺。在这样的情况下，应该使用根据一个实施方案的吊钩或鳄鱼夹适配器。如果脉管进入设备是导管，则应该使用含盐液来建立通过导管的内腔之一的导电路径。在这样的情况下，应该使用根据一个实施方案的注射器-导管适配器。
电子模块(130)从适配器和放置在患者皮肤上的一个或更多个其他电极(115)接收电信号。可替换地，多于一个适配器可以同时用于连接到多于一个血管内设备，以便将不同的电信号提供给电子模块。皮肤电极的使用在某些设备构造中是可选的。电子模块对这些电信号进行处理，并且将它们发送到用于进一步处理和其他功能的计算机模块(140)。在一个实施方案中，电子模块和计算机模块可以分别封装，在另一个实施方案中，它们可以集成在同一包装中。在一个实施方案中，电子模块与计算机模块之间的连接可以是硬连线的，在另一个实施方案中，它可以是无线的，比如，使用蓝牙。
计算机模块通过应用当前实施方案所述的算法(170)对来自电子模块的信号进行处理。计算机模块还可以连接至外设(160)，比如，打印机或标签打印机和储存设备，并且提供与其他计算机或互联网的连接，包括无线连接(150)。储存设备可以用于储存知识数据库和关于手头的应用的信息。连接接口可以用于远程地以最新的相关知识和信息来更新该数据库，所述最新的相关知识和信息比如为新的临床病例、关于电描记图与心脏病之间的关系的新发现。计算机模块支持为了手头的临床应用的目的而优化的图形用户界面(180)。
图1B是根据本发明的实施方案的用于获取并处理血管内心电图的电子模块(2)的框图。
患者连接器接口(10)使得可将电引线与患者(5)连接。可以使用皮肤电极和/或使用上述适配器与血管内设备的电连接的任何组合。在一个实施方案中，放大器(20)是具有可变增益的四级放大器，其可以放大通过患者线缆的电信号，例如，通常为心电图值。模数转换器(30)将信号转换为微处理器(40)可读的数字格式。任何数量和构造的微处理器、微控制器和数字信号处理器可以用于实现微处理功能(40)。
在一个实施方案中，微控制器负责控制通过串行接口(70)或者通过无线接口(80)与计算机模块(90)的串行通信，并且数字信号处理器(DSP)负责实现本文所述的具有创造性的算法中的一种或几种。可替换地，单个处理器可以用于通信和处理这二者。
微处理器(40)还从计算机模块(90)接收命令，并且相应地控制电子模块的不同元件，比如，放大器(20)。患者隔离块(50)使电源(60)和串行通信信道(70)与患者接口(10)电解耦(decouple)，以便确保患者触电保护。在一个实施方案中，隔离块(50)可以由变压器和/或耦合器，比如，光耦合器构成。
图2描绘根据本发明的实施方案的用于血管内的设备的适配器(200)。如导管、注射器、注射器针头、管闩(stopcock)、输注泵及其他的脉管进入设备通过标准连接彼此连接。例如，在图2中，通过设备(201)上的具有内径(203)的鲁尔接头(202)以及设备(250)上的具有内径(252)和流体开口直径(253)的螺纹端口(251)，来图示说明两个设备之间的这样的标准连接。螺纹端口(251)和鲁尔接头(202)允许通过螺接、附接、耦接等方式使端口(251)进入鲁尔接头(202)，来连接这两个设备(201、250)。
适配器(200)包括具有两端(226、227)的本体(220)，并且适配器(200)由例如具有一定程度的弹性的强生物相容性塑料材料制成。端(227)具有锥形形状。在一个实施方案中，端(227)具有弹性密封部分(228)，以致该端(227)可以容易地适配在设备(201)的鲁尔接头(202)中，以密封连接用于流体流动。另一端(226)具有标准的鲁尔接头形状，例如，举例说明，具有设备(201)的鲁尔接头(202)的形状。设备(250)的螺纹端口(251)可以被连接到适配器(200)的一端(226)。锥形部件(227)还允许到不具有鲁尔接头的设备的连接。独立的锥形部件(270)允许在具有不同可进入直径的两个设备之间的连接。适配器(200)的一端(227)适配在锥形部件(270)的直径(272)之内。锥形部件(270)的一端(271)适配在一般设备(260)的简单导管端部分(261)中。例如，设备(260)可以为用于可植入端口的导管。
在一个实施方案中，设备(201)为注射器针头，并且设备(250)为注射器。诸如导电电解液的流体通过具有特定直径的中心内孔或内腔(222)流过适配器(200)，并且在设备(250、201)之间提供流体路径。导电金属环(240)被附接到内腔(222)的基本上为圆柱形的表面的一部分，并且优选地，几乎不对流体流动造成微扰。例如，金属环(240)可以被设置在内腔(222)的基本上为圆柱形的表面的凹陷部分中。导电丝(233)的一端(230)电气地耦合到金属环(240)；在一个实施方案中，该端(230)被焊接到金属环(240)。在另一实施方案中，该端(230)被夹(capture)在内腔(222)的表面和金属环(240)之间，并且该端(230)和金属环(240)通过机械性压力保持良好的电接触。丝(233)可以是裸露的或者是被绝缘的。在优选实施方案中，金属环(240)使用例如粘合剂、紧配合、压入配合等被固定附接到内腔(222)的表面，而在其他实施方案中，金属环(240)可以以可自由移动的方式(free-floating)等被可移除地附接到内腔(222)的表面。
丝(233)通过通道(231)，该通道(231)从内腔(222)延伸到本体(220)的外表面中的开口。环氧树脂(232)或者其他适合的材料可以被用来密封通道(231)的开口，并且用来为丝(233)提供应力释放。金属环(240)可以被有利地设置为邻近通道(231)，来提供附加的密封。因此，金属环(240)、丝(233)、通道(231)以及环氧树脂(232)为流过适配器(200)的流体提供密封的电气连接。连接器(234)可以提供到电图系统的标准电连接；还可以使用无终止的(non-terminated)丝。在一个实施方案中，丝(233)终止于通道(231)的开口处并且连接器(234)被直接附接到本体(222)，而在另一实施方案中，丝(233)延伸通过通道(231)的开口并且连接器(234)被附接到丝(233)的自由端。
在一个实施方案中，内腔(222)的基本上为圆柱形的表面沿纵向方向成锥状。该锥状可以沿内腔(222)的整个长度延伸或者被约束到该长度的一特定部分。例如，内腔(222)的表面可以为锥形并且在近侧端具有更大的直径，或者可替换地，更大的直径可以位于远侧端处。
在一个实施例中，设备(201)为插入用于可植入端口的导管的内腔的注射器针头，并且设备(250)为注射器。注射器被装满含盐液，该含盐液然后通过适配器(200)被注入导管。由此，适配器(200)变得装满含盐溶液(salinesolution)，并且因为导电金属环(240)与含盐液和导电丝(233)接触，所以在导管内腔和丝(233)之间建立电气连接。以这种方式，导管末端处的电信号可以通过含盐溶液被测量。还可以使用其他导电溶液来使用适配器(200)获得血管内的电图。在另一实施方案中，适配器(200)可以与输注泵以及其他类型的动力注入设备一起使用。在可替换的实施方案中，适配器(200)不包括金属环(240)，并且导电端(230)与电解液直接接触。
图3图示说明根据本发明的实施方案的导管操控设备。在该实施方案中，导管(300)为三内腔导管，并且每个内腔的远侧端相对于彼此是间隔开的。导管操控设备可以与具有两个或更多个内腔的任何导管一起使用，其中该两个或更多个内腔具有间隔开的远侧内腔开口。导管(300)的一个内腔(306)的开口端恰处于导管的远侧端处，另一端或内腔(305)的开口自远侧端向后间隔开，而再一端或第三内腔(307)的开口相比于第二端(305)向后间隔开。开口端(306)与端(307)之间的距离一般为从一厘米至数厘米。
多种导管包括多个具有间隔开的端的内腔，并且具有创造性的操控设备可以适应这样的导管。例如，在外周置入中心导管的情况下，导管的一般长度为50至60厘米，并且远侧内腔端(305、306和307)两两之间的间隔为从一厘米至数厘米。具有两个内腔的血液透析导管在长度上可以一般地为20至40厘米，其中在两个内腔的远侧端之间具有一厘米至数厘米的间隔。多内腔中心静脉导管(CVC)在长度上可以一般地为15至25厘米，其中内腔的远侧端或内腔的开口之间具有从数毫米至数厘米的间隔。
在近侧端，导管具有导管毂(catheterhub)(301)，该导管毂(301)分出三个内腔并且使每个内腔与一鲁尔接头(302、303、304)连接。具有创造性的导管操控设备包括探针(310)和操控构件(320)，探针(310)在近侧端具有柄(311)来允许进行推动、拉动以及使用后的移除，操控构件(320)连接到探针(322)的远侧端并且可以被馈接回到其余内腔中的一个(例如，举例说明，内腔(307))的远侧内腔开口中。操控构件(320)通过导管内腔回到导管的近侧端并且在近侧端伸出对应于各自内腔(304)的鲁尔接头。这样设置，操控设备处于安装位置。在一个实施方案中，构件(320)具有柄(321)，该柄(321)可以用来拉动该构件通过内腔。在另一实施方案中，柄(321)是从构件(320)可拆卸的。
构件(320)可以为聚氨酯、硅有机树脂、PTFE或者其他类似的材料。在不同的实施方案中，构件(320)可以为任一种生物可相容的线，例如外科手术线。在另一实施方案中，构件(320)为不锈钢丝。在一个实施方案中，提供预插入导管内腔中的一个的探针，一般地具有最远侧开口(306)的中心内腔使得构件320附接于探针(322)的远侧端并且通过内腔开口(307)预插入到内腔(304)中。为操控导管，在防止探针310被拉入导管的同时，使用者将构件320拉出导管。因而，导管末端可以在一期望的方向上被弯曲。由弯曲导管末端(350)、构件(340)和构件(330)来图示说明这种情形，其中构件(340)被拉回，构件(330)相对于导管处于其初始位置。如果探针(310)或操控构件(320)或者二者由任一导电材料制成，则它们中的每个或二者可以通过将其近侧端连接到血管内的电图系统，而被用来测量导管远侧末端处的电信号或者血管内的电图。在一个实施方案中，操控构件(320)可以通过导管内腔的开口(307)被绑到探针(310)。
在另一实施方案中，探针(310)和操控构件(320)被加工为单个部件来形成扩展的操控构件，该扩展的操控构件通过一不同的导管内腔的开口(305)形成回环。通过将该扩展的操控构件的两端中的一个拉过鲁尔接头(304)和(302)而露出，实现相同的效果，并且导管末端可以在一期望的方向上被弯曲。在另一实施方案中，在双内腔导管的情况下，探针(310)可以被插入一个内腔中并且操控构件(320)可以被插入另一个内腔，以至于弯曲导管末端的效果可以通过拉动近侧端来实现。在进一步的实施方案中，操控构件(320)可以被插入内腔(302)并且通过开口(305)。
图4A、图4B、图4C和图4D描绘根据本发明的各个实施方案的提供血管内心电图的最佳获取的电极构造。
图4A描绘具有参考电极(410)和通过适配器附接到血管内设备的另一个电极(415)的单导联构造，参考电极(410)例如附接到患者右臂上的皮肤。附接到右臂上的皮肤的参考电极仅出于举例说明的目的而出现在该构造中。根据所需的ECG的类型，参考电极的其他位置是可以的。右臂上的参考电极连同与适配器一起使用的血管内设备的末端一起可以与标准ECG的导联II类似。在这种情况下，从上腔静脉(401)和下腔静脉(402)获得的ECG可以被优化。参考电极可以在任何其他位置附接到皮肤，以便模拟标准ECG的其他导联。参考电极还可以与附接到其他血管内设备的适配器连接，以便从患者的心脏(400)内获得更多的局部信息。
图4B描绘具有监控和引导能力的、具有4个电极的改进的3导联构造。三(3)个电极对应于标准ECG电极：用作参考的右臂(RA，420)、左臂(LA，425)和左腿(LL，430)。第四电极通过适配器附接到血管内设备(C，435)。在该构造中，电子模块和算法同时执行两种功能：三个标准电极(RA、LL和LL)执行心脏的监控功能，同时C电极(435)使得可记录设备末端处的ECG。
图4C描绘具有单接地导联的遥测构造，该遥测构造包括图4A中所图示说明的构造和地参考(450)。该构造可以用于远程地通过遥测系统构造发送ECG。
图4D描绘用于引导血管内设备的ECG监控器的一种用法。使用具有标准输入RA(465)、LA(460)和LL(470)的标准ECG监控器。LA(460)与患者的左臂连接，LL(470)与患者的左腿连接。RA输入(465)与开关连接，该开关可以用于临床医生在RA电极与导管(C)电极475之间切换RA输入(465)。因此，可替换地，可以实现导管放置的监控或引导。
图5图示说明中心静脉系统中的不同位置处的示例性心电图信号幅值。
图示说明了心脏(504)、右心房(501)、上腔静脉(SVC)(502)和下腔静脉(IVC)(503)。位置A在上部的SVC中，位置B在SVC的下三分之一处，位置C在腔静脉-心房接点(junction)处，位置D在右心房中，位置E在上部的下腔静脉中。
曲线图510图示说明在位置A处记录的作为时间的函数的ECG波形。波形的绝对幅值记录在幅值标度尺(590)上。在血管内ECG的情况下，图示说明了心电图的标准元素：P波(560)、R波(570)和T波(580)。利用如图4D中所示的导联构造记录的、位置A处的幅值和形状与利用相同的电极构造在皮肤层面记录的心电图类似。
曲线图520图示说明在位置B处描绘的血管内ECG。该位置处的幅值高于位置A处的幅值，但是波形的整体形状在位置A和B处类似。
曲线图530图示说明在位置C处描绘的血管内ECG。在腔静脉-心房接点的位置C处，波形的幅值更加高于位置B处的幅值，并且P波显著地改变而变得高于R波(R-波)。该波形是窦房结的接近度的指示。
曲线图540图示说明在位置D处描绘的血管内ECG。在右心房中的位置D处，幅值与位置C处的类似，但是P波改变极性而变为双极性。这是ECG的测量超过窦房结发生的指示。
曲线图550图示说明在位置E处描绘的血管内ECG。在下腔静脉中的位置E处，波形就幅值而言与位置A处的波形类似，除了P波具有相反极性之外。本文介绍的算法使用不同位置处的ECG波形的差异来区分对应位置和评估心脏和血管机能。
图6使用谱标度尺(690)图示说明中心静脉系统中的不同位置处的示例性心电图信号功率谱。
图示说明了心脏(604)、右心房(601)、上腔静脉(SVC)(602)和下腔静脉(IVC)(603)。曲线图610图示说明在位置A处描绘的血管内ECG谱。在位置A处，谱(610)具有单一中心频率或单频带(660)的外观，并且频率分布谱功率和能量类似于皮肤层面的频率分布谱功率和能量。
曲线图620图示说明在位置B处描绘的血管内ECG谱。在位置B处，频率分布具有两个主频带以及比位置A处的能量和谱功率更高的能量和谱功率。
曲线图630图示说明位置C处的血管内ECG谱。在位置C处，存在分布在更大范围频率(670)上的多个(3-4个)主频率或主谱分量。该谱分布指示窦房结周围的能量分布。与位置B相比，谱功率和信号能量有所增大。
曲线图640图示说明在位置D处描绘的血管内ECG谱。在位置D处，谱更宽并且宽带更多，指示右心房的电活动。
曲线图650图示说明在位置E处描绘的血管内ECG谱。位置E处的频谱与位置A处的频率类似。本文介绍的算法使用不同位置处的谱波形的差异来区分对应位置和评估心脏和血管机能。
图7图示说明中心静脉系统中的不同位置处的示例性心电图信号电能分布。图示说明了心脏(704)、右心房(701)、上腔静脉(SVC)(702)和下腔静脉(IVC)(703)。曲线图(710、720、730、740、750)描绘不同位置(分别地，A、B、C、D和E)处的能量分布，本文介绍的算法使用随时间的变化来区分对应位置和评估心脏和血管机能。
考虑下图16，图示说明根据本发明的实施方案的用于分析血管内的电图信号的架构。心脏由(1600)表征，上腔静脉由(1601)表征，下腔静脉由(1602)表征，并且右心房由(1603)表征。在该实施方案中，存在三个感兴趣的区域用于放置中心静脉进入设备：上腔静脉或SVC的下三分之一(1605)、腔静脉-心房接点或CAJ(1606)以及上右心房或RA(1607)。
曲线图(1620)图示说明根据心脏中的部位的电能分布，并且曲线图(1640)图示说明可以在心脏中的不同部位获得的不同的电图波形。曲线(1630)图示说明在从上腔静脉行进到心脏中的血管内的导管的末端处的每个区域检测到的电能的增加。在一个实施方案中，能量曲线在时域中被计算，而在另一实施方案中，能量曲线使用频谱在频域中被计算。在一个实施方案中，能量被针对实际信号水平来计算，而在另一实施方案中，基线值或其他均值在计算能量之前先从信号值被减除。在确定的时间段(例如心跳)内，通过在减除基线之前和/或之后求平方幅值的总和，来在时域中计算信号能量或功率。在频域中，通过求频率分量的平方值的总和，来计算信号能量或功率。在一个实施方案中该曲线使用整个电图来计算，而在其他实施方案中，只有电图的特定段(例如只有对应于心电图的“P波”的段)被用于能量计算。这样的“P波”段是窦房结的电活动的表征。
不同水平的能量使沿从SVC到心脏的导管路径的不同部位特征化。这些区域可以通过使用阈值借助于其电能水平而被区分。能量水平的阈值(1631)限定上腔静脉的下三分之一的开始。能量水平(1621)限定脉管系统中具有低能量的区域，该区域远离或离开窦房结。阈值(1631)和(1632)之间的能量水平(1622)限定被标记为上腔静脉的下三分之一(1625和1605)的区域。阈值(1632)和(1633)之间的能量水平(1623)限定被标记为腔静脉-心房接点(1626和1606)的区域。阈值(1633)和(1634)之间的能量水平(1624)限定被标记为右心房(1627和1607)的区域。
类似地，曲线图(1640)中的电图相对于基线(1650)的形状和大小可以与心脏中的部位相关。阈值(1631)、(1632)、(1633)和(1634)针对被考虑进行计算的能量的类型而被具体地确定，例如整个电图、P波和/或S-T段。在SVC的下三分之一之前并且对应于相对低水平的能量(1621)，P波(1651)和R波(1652)在大小和形状上是相似的，其中如果右臂标准ECG导联被连接到导管并且测量导管末端处的电图信号，在皮肤层面记录标准心电图导联II。在SVC的下三分之一(1605和1645)中，电图的能量水平增加，电图幅值增加，并且P波(1653)相对于R波(1654)将幅值和能量增加到P波幅值和能量介于R波的幅值和能量的一半和四分之三之间的情况。在腔静脉-心房接点(1606和1646)处，电图的能量水平进一步增加，电图幅值继续增加并且P波(1655)相对于R波(1656)将幅值和能量增加到P波幅值和能量大于或等于R波的幅值和能量的情况。在右心房(1607和1647)中，电图的能量水平进一步增加，电图幅值增加，P波(1657)成为双极的并且其幅值和能量相对于R波(1658)开始减小。这些行为被量化、分析和使用，从而提供关于导管末端的定位信息。
考虑下图17，图示说明数个电图波形处理实施方案。曲线图(1710)和(1720)图示说明P波分析实施方案。因为P波对应于由窦房结生成的心脏的电活动，所以在血管内的方式中，P波的变化相对于确定窦房结的接近度是最相关的。因此，为评估窦房结的接近度和在脉管系统中的定位，时域和频域中的信号分析方法以及信号能量标准可以仅仅被应用到电图的P波段。在曲线图(1710)中，被指定用于P波分析的段(1711)开始于时刻(1713)并且结束于时刻(1714)。在P波段的开始时刻和结束时刻之间的时间段期间，所检测到的最高幅值对应于P波峰(1712)。P波段分析的开始时刻(1713)可以以多种方式确定。在一个实施方案中，心跳被计算并且R峰被检测作为心跳的最大幅值。从每个R峰回落心跳的一特定百分比(例如介于20％和30％之间)，确定P波分析开始的时刻(1713)。从每个R峰回落心跳的2％到5％确定被指定用于P波分析(1714)的段的结束。类似地，在曲线图(1720)中，针对P波分析的指定段(1721)开始于心搏周期中的时刻(1723)并且结束于时刻(1724)。这种情况下的P波为双极的，当相比于基线(幅值等于零)时具有正最大幅值(1722)和负最大幅值(1725)。针对限定在开始时间点(曲线图1710上的1713以及曲线图1720上的1723)和结束时间点(曲线图1710上的1714以及曲线图1720上的1724)之间的P波形，根据本发明的实施方案应用时域和频域算法。
曲线图(1730)图示说明在计算信号能量之前减除基线的好处。如果在心跳期间，信号能量在时域中被计算为平方信号幅值的和，则基线(1733)附近的水平线(1731和1732)之间的幅值变化可以导致比具有水平线(1734和1735)之间(由此水平线(1734)为基线)的幅值变化的信号低的能量水平。基线值(1733)从幅值(1731到1732)被减除并且基线值(1734)从幅值(1734到1735)被减除。在减除基线之后，平方幅值的和被计算。因而，该和与基线附近的信号变化的能量成比例，并且因此更适合的是，特征化信号值/行为中的变化。
曲线图(1740)示出具有P波(1741)和R波(1742)的一般电图波形，以及P波被高频噪声(1744)覆盖且R波饱和到最大值(1743)的失真信号。在存在这些种类的伪差(artifact)(1744和1743)的情况下，恢复原始信号(1741和1742)是非常困难的并且有时是不可能。因此，根据本发明的实施方案，算法被用来检测伪差的存在并且尽可能多的减少伪差的量。如果，在减少伪差之后，信号无法被恢复，则该信号对信号能量的计算来说是被丢弃的。在时域中，可以通过导数的高值及其积分的高值、信号能量中的跳变(jump)、基线的值中的跳变或者从信号计算的不同的平均值，来检测伪差的存在。在频域中，当DC分量(谱的频率为零)的值中有跳变、当高频分量突然出现以及功率谱/能量谱中有跳变，可以检测到有伪差。在频域中，选择性的滤波可以被应用并且对信号的平均行为来说不是“一般的”的所有分量被去除。在选择性的滤波之后，信号在时域中使用逆傅里叶变换被重构，从而允许检验选择性滤波的成功。
图8描绘根据本发明的实施方案的图形用户界面。
窗口(810)在ECG波形被使用附接的电极构造的电子模块获取时呈现该ECG波形。窗口(820)是参考窗口，示出用于与当前窗口进行比较的定格波形(frozenwaveform)。在一个实施方案中，窗口(820)中的参考波形可以通过在导管的参考位置处与电子模块连接的电极和/或使用皮肤电极的参考构造来获得。例如，这样的参考波形可以是使用根据本发明的实施方案的与放置在腔静脉-心房接点的血管内设备连接的适配器记录的ECG。在不同的实施方案中，当被记录在波形数据库中和被储存在计算机系统的储存介质中时，窗口820中的参考波形可以是脉管系统中的某个位置处的典型波形或者某个心脏病的典型波形。如果电极构造使得可使用血管内设备同时进行心电图的心脏监控和记录，则窗口(830)示出用于心脏监控的标准ECG导联之一，而窗口(810)示出当血管内设备与适配器(诸如上述的适配器)连接时血管内设备的末端处的ECG。
图标(870)是心脏的表征，位置A至E(875)图示说明心脏和血管系统中的不同位置，这些位置可以通过根据本文公开的方法分析血管内ECG来进行区分。当脉管系统中的位置通过算法识别时，图标(875)上的对应地方和字母变得高亮，或者以某种其他方式使得图标(875)上的对应地方和字母对于使用者是可见的。条(884)、(885)和(886)示出信号能量水平。“E”条(885)呈现从血管内设备的末端的当前位置处的ECG频谱计算的电能的量。“R”条(884)呈现从参考位置处的ECG频谱计算的电能的量。“M”条(886)呈现从使用来自皮肤电极的监控ECG信号的ECG频谱计算的电能的量。窗口(840)描绘监控信息，比如，心率。患者信息(姓名、手术日期及其他)在窗口(850)中被示出。窗口(860)包含系统控制元件(比如按钮)和状态信息(比如缩放、滚动速度、系统参数和系统诊断)。
图9描绘根据本发明的另一个实施方案的图形用户界面。
图标(920)是心脏的表征，位置A至E(930)图示说明心脏和血管系统中的不同位置，这些位置可以通过分析血管内ECG来进行区分。当脉管系统中的位置通过算法识别时，图标(930)上的对应地方和字母变得高亮，或者以某种其他方式使得图标(930)上的对应地方和字母对于使用者是可见的。条(940)、(950)和(960)示出信号能量水平。“E”条(940)描绘从血管内设备的末端的当前位置处的ECG频谱计算的电能的量。“R”条(950)示出从参考位置处的ECG频谱计算的电能的量。“M”条(960)示出从使用来自皮肤电极的监控ECG信号的ECG频谱计算的电能的量。按钮“打印”(960)使得使用者可在打印机上(例如，在标签打印机上)打印记载病例的信息，以快速地贴附到患者的病例表。
图10A和图10B描绘根据本发明的实施方案的图形用户界面所显示的信息的示例性打印输出。
图10A图示说明将导管末端放置在SVC的下三分之一处的手术的情况的打印输出(1000)。区域1010描绘心脏图标，由此对应于上腔静脉(SVC)的下三分之一的字母“B”高亮(1040)。区域1030描绘在窦房结附近的腔静脉-心房接点的导管末端处记录的参考ECG波形。区域1020描绘在手术结束时其被放置的位置上的导管末端处的ECG波形。关于图10A，该位置是SVC的下三分之一，并且ECG波形对应于该位置。患者姓名(1001)和手术日期(1002)也被打印。
图10B描绘类似的打印输出(1050)，除了手术结束时的最终位置是在心脏图标(1060)上的位置C(1090)处的腔静脉-心房接点之外。“SA结”区域描绘参考ECG波形(1080)，“最终位置”区域(1070)示出导管被放置成末端在窦房结处：最终位置上的ECG波形与窦房结(SA结)处的参考位置上的ECG波形类似或者甚至是相同的。已知的是，SA结的接近度指示腔静脉-心房接点的位置。这些位置有时被一些临床医生认为是相同的。
图11是用于使用心电图信号将血管内设备定位在心脏的内部或附近的基于计算机的方法(1100)的框图。
所述算法应用于由适配器获取的到达血管内设备(并且可选地，还通过皮肤电极)的输入信号(1102)(ECG)。错误检测块(1105)检测至少三种类型的错误状况/异常，例如，当除纤颤器已应用于患者时，当起搏器激起激励脉冲时，和/或当引线/电极脱离时。这些错误/异常可以被不同地处理，并且使用者可以被告知异常的存在和处理异常的方式(1110)。
预处理块(1115)可以放大信号、降低噪声、除去伪差等。在一个实施方案中，将信号重新缩放到显示范围在使用者控制下发生，并且不是自动的，与最近可用的ECG监控器一样。因此，ECG的幅值的改变易于被注意到。高通滤波器校正基线，并且减少诸如呼吸伪差这样的伪差。宽带噪声抑制可以使用选择性滤波器(比如，小波变换)来实现。对其他设备和电网的心电图干扰可以通过以60Hz或50Hz为中心的陷波滤波器(窄带滤波器)来抑制，以适应国内或国际电源。高频噪声可以利用低通滤波器抑制，在一个实施方案中，所述低通滤波器利用可变长度平均来实现，所述可变长度平均例如为与心搏周期对应的运行窗口、几个连续心搏周期期间的ECG的平均，等等。自适应滤波块(1120)通过使误差信号最小来优化滤波器系数。
时域模式识别块(1130)识别ECG波形的元素、它们的关系(一个或多个)和它们随时间的行为(一个或多个)。块1130中的时域模式识别算法以及频域模式识别块1140的重要方面是数据历史。对于某些元素，实时分析ECG，而对于其他元素，在电子和/或计算机模块的存储器中维护具有合适缓冲长度的数据缓冲器，以便使得可进行历史数据分析和基于该分析的预测。在一个实施方案中，数据历史缓冲是使得与几次心跳对应的ECG信号可保存在缓冲器中的几秒长。双缓冲技术使得可在第二缓冲器继续储存信号的同时对一个缓冲器中的波形进行处理。因此，在对一个缓冲器中的波形进行处理时没有信号数据丢失。在一个缓冲器上的数据处理完成之后，结果被发送到决策支持算法(1150)，并且两个缓冲器交换角色。缓冲器的长度适应数据处理的持续时间，以便确保没有数据丢失。类似的双缓冲技术也应用到经历频域模式识别块(1140)的数据。
在血管内ECG的情况下，感兴趣的元素可以包括，但不限于，以下中的一个或更多个：
1、P、Q、R、S、T和U波、它们的峰、幅值和持续时间；
2、P-R、S-T和T-P段/间期(interval)的持续时间；
3、S-T段的升高；
4、P-P和R-R间期的方差；
5、S-T的方差和R-T间期的方差等；
6、P波的峰间值和QRS复合波的峰间值；
7、P波幅值与R波幅值的比率和P波幅值与QRS复合波峰间幅值的比率；
8、P波的极性：单正极、单负极或双极性；
9、P波、QRS复合波和T波的导数；
10、R-R间期和心跳的时间平均值；
11、某个时间段期间的P波幅值/峰的最大值和P波峰间幅值的最大值；
12、某个时间段期间的R波幅值/峰的最大值和QRS复合波峰间幅值的最大值。
在时域中，附加计算包括：
13、基线减除，例如以去除呼吸伪差或者从而允许相对于基线的变化的分析；
14、波形平均以减少噪声；
15、(在基线去除之前和之后)在时域中进行信号幅值的平方和的形式的信号能量计算；
16、用于估算信号变化和去除高频伪差的一阶导数计算；
17、一阶导数值的积分(求和)；
在频域中，附加计算包括：
18、DC和准DC分量去除(等于基线减除和呼吸伪差的去除)；
19、选择性的滤波，即去除与伪差和噪声(例如高频噪声、肌肉伪差、由导管和电极处理造成的信号变化等)相关联的特定频率；
20、用于将信号重构到时域中的逆傅里叶变换。
几种技术可以用于从ECG波形得到以上列出的信息，包括，但不限于，以下中的一个或更多个：
1、“峰检测”；
2、一阶导数的计算；
3、沿着一次心跳中的信号运行平均(runningaverage)和沿着多次心跳运行平均；
4、自适应阈值；
5、自动相关。
块(1125)中的快速傅里叶变换对储存在具有某个长度的缓冲器中的一些ECG采样(比如，256、512、1024、2048或更多的数据采样)执行快速傅里叶变换。傅里叶变换将波形从时域变换到频域。
频域模式识别块(1140)图示说明在频域中对ECG执行的模式识别的各个方面，包括，但不限于，以下中的一个或更多个：
1、主分量分析，即，频谱的最重要元素的确定(类似于确定心电图的形态元素，比如，时域中的某些波和段)；
2、为了减少基于主分量的计算量的数据压缩；
3、主分量的数量和形态的确定，具体地，确定谱是否具有仅一个、两个或多个主频率(频带)；
4、从频谱计算谱功率和信号能量；
5、为了降低宽带噪声沿着单个谱上的频域范围运行平均；
6、为了滤除伪差沿着几个谱运行平均；
7、谱的另外的形态元素的确定，比如，最大频率、最大频率中所包含的能量、频率直方图(即，什么频率包含多少能量)、最高有效的最大能量峰的频率等；
8、从谱分布确定的主分量和其他参数的随时间的行为和平均值的计算，比如，确定某个时间段期间的信号能量的最大值和谱功率的最大值；
9、基于谱分析来确定/估计某些心脏病。该确定/估计也在决策支持块1150和1250中被更详细地执行。
几种决策支持算法使用由时域模式识别和频域模式识别算法提供的信息。在一个实施方案中，块(1150)支持将血管内设备放置在SVC的下三分之一处或者腔静脉-心房接点。
具体地讲，块1150基于在导管放置期间首次到达腔静脉-心房接点的概念。在腔静脉-心房接点或者在窦房结附近，P波和其他电参数达到最大值。在腔静脉-心房接点，P波是单极性的。在到达腔静脉-心房接点的窦房结(即，P峰(P-峰)幅值和谱功率的最大值)之后，将导管向后拉几厘米，直到P波减小到在腔静脉-心房接点达到的幅值的一半为止。在P波减小到腔静脉-心房接点的幅值的一半的位置处，认为导管在上腔静脉的下三分之一中。P波峰幅值或峰间幅值以及谱功率用于将脉管系统中的位置映射到ECG波形。
更具体地讲，在接收到与血管内设备相关联的血管内ECG信号之后，在多个预定时间段期间对该信号进行处理，以计算每个预定时间段内的P波幅值和谱功率。然后从所述多个P波幅值确定最大P波幅值，并且从所述多个谱功率计算相关联的最大谱功率。将这些最大值被确定所在的位置与心脏内部或附近的预定位置(诸如腔静脉-心房接点)相关联。然后在每个预定时间段内基于P波幅值与最大P波幅值的比率和谱功率与最大谱功率的比率来计算血管内设备的位置，然后向使用者显示血管内设备的位置。另外，还可以使用P波的极性和R波幅值来确定血管内设备的位置。
单个标准或者这样的标准的组合可以用于支持决策制定。在一个实施方案中，T1、T2和T3可以是针对每个患者不同的凭经验建立的阈值，并且所述算法可以基于当前测量使用自适应循环来调整阈值。在另一个实施方案中，这些阈值是预定的。
在其他实施方案中，P峰/P幅值或P波峰间幅值与R峰/R幅值或与QRS复合波峰间幅值之间的比率也可以用于建立相对于窦房结的位置。在一个实施方案中，P峰/幅值必须是R峰/幅值的大约一半，并且对于与SVC的下三分之一对应的位置，P波必须是单极性的。在另一个实施方案中，P波峰间必须是QRS峰间幅值的一半，并且对于与SVC的下三分之一对应的位置，P波必须是单极性的。
如上所述，可以例如通过将心脏图标上的与被系统识别的ECG的类型对应的合适位置加高亮来向使用者呈现决策支持算法块1150的结果(1160)。
图12中描绘的决策支持算法块1250基于将当前位置处的P波、R波和P波谱功率与从等效导联(比如，导联II)中的皮肤心电图确定的这些参数的值进行比较。阈值T1至T6是经过相对于每个患者的自适应调整的经验值。可以使用图12中所示的每个标准或标准的组合。
还可以使用其他决策算法，特别是与从ECG谱计算的电能水平相关的决策算法。在放置血管内设备的情况下，一个标准可以是，在与SVC的下三分之一对应的位置处，从血管内ECG计算的平均电能高达从皮肤层面的血管内ECG或者从对应导联(比如，导联II)中的皮肤ECG计算的平均电能的两倍。
用于放置中心静脉导管的方法
下面呈现放置中心静脉导管(CVC)的方法。
1.估算或测量用于给定患者的脉管进入设备(CVC)的所需长度。
2.如果使用含盐液和适配器(200)，则跳到步骤11；如果不是，则如下进行。将导丝插入CVC并且将导丝末端和导管末端齐平对齐。测量CVC之外的导丝的长度。为在将导丝插入脉管系统之后能够使导管末端和导丝末端重新对齐，这一测量是必需的。在诸如利用无菌测量管或者利用外科手术线进行测量之后，将导丝从CVC移除。
3.针对估算的所需长度，进行脉管进入并且插入导丝。
4.在丝上插入CVC，从而使在步骤1所测量的长度的导丝留在CVC之外。由此，在丝上插入的CVC和导丝末端是齐平对齐的。
5.针对每条用于使用的指令，将无菌电气适配器连接到导丝。
6.将无菌电气适配器的另一端连接到电图系统的ECG线缆。
7.针对每条使用电图系统的指令，检查电图系统的显示器指示导管末端的期望位置：在SVC的下三分之一中，腔静脉-心房接点或右心房处。一般地，导管末端的定位将会是通过电图的P波的特定形状以及P波相对于R波的特定形状为可识别的，和/或将会是由能量水平和阈值可识别的。
8.通过一起拉动和/或推动导丝和CVC而不改变齐平对齐来调整导丝和CVC的位置，直到屏幕上的ECG波形指示已经达到期望的位置为止。使实际插入的长度与估算长度相关。
9.在已经达到该位置之后，断开电气适配器的连接并且移除导丝。
10.将CVC固定在适当部位上。
11.如果使用含盐液和适配器(200)则在此继续。
12.如现有规程当前所规定的进行脉管进入并且在导丝上引入CVC。
13.移除导丝。
14.将无菌适配器(200)附接到CVC。
15.将适配器(200)的电气连接部分(234)附接到电图系统的ECG线缆。
16.以含盐液填充注射器并且将其连接到适配器(200)的另一端。以含盐液冲洗导管内腔，以创建一路通过导管末端的导电盐柱。
17.针对每条使用电图系统的指令，检查电图系统的显示器上所示的ECG波形指示导管末端的期望位置：在SVC的下三分之一中，腔静脉-心房接点或右心房处。一般地，导管末端的定位将会是通过电图的P波的特定形状以及P波相对于R波的特定形状为可识别的，和/或将会是由能量水平和阈值可识别的。
18.通过拉动和/或推动来调整CVC的位置，直到屏幕上的ECG波形指示已经达到期望的位置为止。使实际的长度与估算长度相关。
19.在已经达到期望的位置之后，移除注射器和适配器(200)。
20.固定导管。
用于放置可植入端口的方法
放置可植入端口的导管部件方法与用于放置CVC的方法类似。适配器(200)应当被连接到可植入端口的导管，并且具有含盐液的注射器必须被连接到通用适配器的另一端。不同的电气适配器应当被连接到放置在可植入端口的导管中的注射器针头。在达到期望的位置之后，导管应当被连接到可植入端口。
用于放置开口端式和闭口端式外周置入中心导管的方法
开口端式和闭口端式外周置入中心导管(PICC)二者可以如本文所描述的被放置，并且PICC放置的方法类似于放置CVC的方法。本文所描述的具有创造性的操控机构可以用来在导管无法在期望的方向上行进的情况下使PICC末端弯曲。
用于放置血液透析导管的方法
用于放置血液透析导管的方法类似于本文所介绍的用于放置CVC的方法。本文所描述的具有创造性的操控机构可以用来在导管无法在期望的方向上行进的情况下使血液透析导管末端弯曲。具有适配器(220)的两个不同的导丝可以被用于血液透析导管的内腔中的每个，从而使用电图系统导引一个内腔放置到右心房中而导引另一个内腔放置在腔静脉-心房接点处。通过连接内腔中的每个的适配器(220)与电图系统的ECG线缆的不同电极，血液透析导管的内腔中的每个可以被按顺序地单独放置或者同时放置。
用于在心律失常的患者体内放置中心静脉进入设备的方法
传统地，因为缺乏P波形状上的可视改变，所以心律失常的患者无法使用血管内的ECG方法进行导引中心静脉管路放置的过程。用于本文所述的P波分析的能量标准可以被用来导引在心律失常患者体内的中心静脉进入设备的放置。在心律失常患者的体内，窦房结生成的电信号具有一定程序的随机性，以致它们无法被同步来产生一致的P波。然而，如先前的研究已经示出的，窦房结的电活动存在并且生成相对于窦房结的接近度具有特有的强度的电能。在一个实施方案中，算法使用如从血管内的电图所测量的能量，从而映射脉管系统中的特定部位。这样，当仅以电能而不是P波形状指示部位时，该算法可以被用来导引在心律失常的患者体内进行的放置。
用于监控末端定位和心脏的电活动的特定方面的方法
使用本文所介绍的设备，心脏的电活动的特定方面可以被持续地或间歇地监控。连接到电图系统的电气适配器或者适配器(200)可以被用来进行监控。电气适配器可以被连接到被引入任一静脉进入设备或任一动脉设备中的任一探针或其他导电构件。只要导电溶液(例如含盐液)的输注是可能的，适配器(200)还可以被连接到任一静脉或动脉管路。当导电流体使用输注泵被输入身体中时，适配器(200)也可以被使用。监控末端定位和/或心脏的电活动的特定方面可以在多种临床情况下进行。
1.例如在床边和/或在家护理情形中，在插入后，适配器(200)可以被附接到多个中心静脉设备：PICC、CVC、血液透析导管。通过根据本发明的实施方案将适配器连接到这样的导管以及连接到电图系统，并且通过将含盐液注入导管，在适配器通过使用与上面在本发明的实施方案中所介绍的方法类似的方法被连接的时间期间，导管末端的定位可以被确认和/或心脏的特定电活动可以被监控。
2.适配器(200)可以被连接到动脉管路，介于该动脉管路与连接到该动脉管路的其他设备之间。在动脉管路和通用适配器中的血液确保血液和电图系统之间的电气连接。由此，心脏的电活动可以被持续地监控。在ECG波形的S-T段期间监控前负荷(preload)变化(转变为心脏的电能变化)的情况下，这一点尤为重要。
3.在进行中心静脉压力测量时，还可以通过使用电图系统并且将适配器(200)连接在中心静脉管路和压力测量系统之间，来实现末端定位监控以及心脏的电活动的监控。
4.在可植入端口的情况下，针头可以被插入端口腔室并且导管可以使用装满含盐液的注射器来以含盐液冲洗。电气适配器可以被附接到针头并且被附接到电图系统。通过注入的盐柱检测到的电图信号将包含来自针头与皮肤相接触部位的皮肤层面以及来自导管末端的信息。因为到导管末端的路径的阻抗低于到皮肤的路径的阻抗，所以检测到的信号包含两个分量，即在皮肤层面和在导管末端处。根据在本发明的实施方案中描述的算法，通过减去皮肤层面信号，导管末端处的信号可以被估算并且由此末端位置和心脏的特定电活动可以被估算。
图13图示说明心脏的心脏传导系统，而图14图示说明心脏的传导系统中的电信号传播。
这些图示出心脏的传导机制，该传导机制解释了所测量的心脏内的电能分布为何指示心脏内的特定位置。因此，可以测量局部电信号、行为和能量浓度，并且可以更精确地确定心脏和血管内的位置；还可以更精确地描述局部心脏症状。
心脏的传导系统起始于心脏的主导起搏器、窦房结(1310)。SA结的固有速率是60至100次心跳/分钟。当脉冲离开SA结时，在它进入房室(AV)结(1320)和心室的途中，它沿着巴赫曼束(Bachmann’sbundle)(1350)和结间通路行进通过心房。在脉冲穿过AV结之后，它行进到心室，首先行进到希氏束(bundleofHis)(1330)，然后沿着束支(bundlebranch)行进，最后行进到浦肯野纤维(Purkinjefiber)(1340)。由于结合组织(junctionaltissue)中的起搏细胞和心室上的浦肯野纤维从SA结接收脉冲，所以它们通常保持休眠。仅当它们不从SA结接收脉冲时，它们发起脉冲。AV接点的固有速率是40至60次心跳/分钟，心室的固有速率是20至40次心跳/分钟。图14中示出了电脉冲的不同传播速度。脉冲从SA结(1410)起以大约0.5m/s(米/秒)传播通过心房肌(1420)和心室肌(1460)，以大约2m/s传播通过束支(1440)和(1450)，以大约4m/s传播通过浦肯野纤维(1470)，并且以大约0.05m/s传播通过AV结(1430)。
甚至是在心律失常的情况下，即，在通过标准皮肤心电图测量的相干P波不存在时，电信号和电能分布也有利地用于识别窦房结的接近度和右心房电活动。尽管在心律失常的一些情况下，在右心房中产生的随机电信号的相干性不足以传播通过身体到达皮肤，但是电能仍存在于右心房中，并且可以被局部血管内测量检测为不相关的P波，即，被检测为ECG波形的P段中的重要电活动。能量测量也对于脉冲传导中的一些局部异常不是那样敏感：改变的自律性(心律失常)、脉冲的逆行性传导、再进入异常。
电信号和电能分布还有利地用于量化心脏机能，比如，与心肌的去极化和伸展(extension)相关的前负荷。
电信号和电能分布还有利地用于引导导丝和引导导管通过主动脉进入到左心中。该方法对于简化左心房和冠状动脉的进入以及减少将血管内设备引导到这些位置所需的对比度和辐射的量是有用的。在不同的应用中，具有创造性的仪器还可以用于引导导管(比如，Swan-Ganz)通过右心室进入到肺动脉中。其他血管内设备可以被引导，并且可以被用于测量心血管系统的其他位置上的血管内电活动，该血管内电活动是通过利用本发明的实施方案中介绍的新型装置测量的电描记图可识别的。
图15图示说明由于神经元控制系统而导致的心血管系统中的电活动。几个导电路径与心脏(1530)和血管(1520)活动的控制机制相关：感受器(1510)(比如，压力感受器)通过延髓中枢(1500)将与血管状态和心脏状态相关的信息发送到神经系统。下丘脑(1540)和高级中枢(1550)涉及对从传感器/感受器接收的信息进行处理并对该信息作出反应。继而，它们将脉冲(1560)发送回血管和心脏。通过测量与控制系统相关的电活动，可以获得以前不能获得的关于心脏病的信息。
图18A图示说明爱氏ECG三角和结合各种实施方案使用于此的ECG导联的命名约定。为获得来自患者的ECG信号，通常，一个电极被放置在右臂(RA)上，一个被放置在左臂(LA)上，并且一个被放置在左腿(LL)上用作参考。P波变化最大的方向由箭头(2200)示出。因此，在一个实施方案中，当使用血管内的ECG进行导管导航和末端定位时，对应于右臂(RA)的电极可操作地连接到诸如导管的脉管进入设备(110)(图1A)的近侧端。以这种方式，例如通过设置在导管上的电极，相对于导管的远侧端检测到的ECG波形可以被认为是由爱氏三角的导联II检测到的。由此，当导管行进通过脉管系统时，导联II将示出P波的最显著的变化，并且因此导联II最适合来检测窦房结的接近度。窦房结位于腔静脉-心房接点处并且负责生成P波(右心房电活动的指示)。在一个实施方案中，如果RA电极可操作地连接到导管，则在导管导航通过脉管系统时，对应于爱氏三角中的导联III的波形相对地保持为未改变。因此，导联III在本发明的实施方案中被用作如本文所述的起到多重作用的参考导联。在一个实施方案中，本文所介绍的装置同时显示针对导联II(本文中也被称为血管内的ECG导联)的基于ECG信号的波形(针对导管导航和末端定位)以及针对导联III(本文中也被称为皮肤ECG导联)的基于ECG信号的波形(作为参考波形)。
再次参照图5，图5图示说明根据一个实施方案的不同的血管内的ECG波形到脉管系统和心脏中的对应部位的映射。具体地，部位A对应于上腔静脉(SVC)，部位B对应于SVC的下1/3，部位C对应于腔静脉-心房接点，部位D对应于右心房，并且部位E对应于下心房和/或对应于下腔静脉。
图18B图示说明如在图5中的部位A所测量的，利用本文公开的设备(例如ECG包含传感器的导管)获得的血管内的(导联II)ECG波形(2215)。皮肤ECG波形(2210)表征等同于导联III的皮肤参考ECG导联。参考P-R复合波由(2280)图示说明。部位A处的一般的P-R复合波由(2250)图示说明。在导联II上的P波根据导管及其ECG传感器在脉管系统中的移动而剧烈变化时，例如在P-R复合波(2250)中可见的，在用作参考(2280)的导联III上的P波基本上保持为恒定的。
如图18B-图18F中所图示说明的，在一个实施方案中，来自两个ECG导联(例如，图18B中的导联II和III)的波形被同时地描绘在装置(例如，举例说明，导管放置系统)的显示器上。如图20F中所示的，在另一实施方案中，三个导联(图18A的导联I、II和III)可以同时被显示。
通过使用本文所介绍的方法、装置和ECG电极配置，可能的是，在一个实施方案中，使用皮肤参考导联(导联III)来监控患者状况(例如，患者的心率)而同时使用血管内的导联II导引导管放置。
图18C图示说明如在图5中的部位B所测量的，利用本文公开的设备获得的血管内的ECG波形(2220)。皮肤ECG波形(2210)表征等同于导联III的皮肤参考导联。参考P-R复合波由(2280)图示说明。部位B处的一般的P-R复合波由(2255)图示说明。如之前的，在对应于导管末端的导联II上的P-R复合波(2250)中的P波剧烈变化时，在用作参考(2280)的导联III上的P波保持为完全恒定的。
图18D图示说明利用本发明的实施方案公开的设备在图5的部位C处获得的血管内的ECG波形(2225)。ECG波形(2210)表征等同于导联III的皮肤参考导联。参考P-R复合波由(2280)图示说明。部位C处的一般的P-R复合波由(2260)图示说明。在对应于导管末端的导联II上的P-R复合波(2260)中的P波剧烈变化时，在用作参考(2280)的导联III上的P波保持为完全恒定的。
图18E图示说明利用本发明的实施方案公开的设备在图5的部位D处获得的血管内的ECG波形(2230)。ECG波形(2210)表征等同于导联III的皮肤参考导联。参考P-R复合波由(2280)图示说明。部位D处的一般的P-R复合波由(2265)图示说明。在对应于导管(265)末端的导联II上的P-R复合波(2265)中的P波剧烈变化时，在用作参考(2280)的导联III上的P波保持为完全恒定的。
图18F图示说明利用本发明的实施方案公开的设备在图5的部位E处获得的血管内的ECG波形(2240)。ECG波形(2210)表征等同于导联III的皮肤参考导联。参考P-R复合波由(2280)图示说明。部位E处的一般的P-R复合波由(2270)图示说明。在对应于导管末端的导联II上的P-R复合波(2270)中的P波剧烈变化时，在用作参考(2280)的导联III上的P波保持为完全恒定的。
图19A图示说明本文所介绍的装置(例如导管放置系统)在其屏幕上同时示出数个显示窗口的能力。一个、两个或更多个显示窗口可以被包括。显示窗口(3310和3320)中的每个可以以任何组合，在实时获取模式、回放模式或者定格模式(frozenmode)下，显示一至三个ECG波形(导联I、II和III)。在一个实施方案中，一个显示窗口(3310)被用来示出实时ECG波形(导管导引或者血管内的导联II和皮肤参考导联III)，而另一个显示窗口(320)被用来示出定格ECG波形(导管导引导联II和皮肤参考导联III)。因而，使用者可以比较在两个不同导管末端定位的导管导引导联中的变化以及特别是P-R复合波中的变化：定格在显示窗口(2320)中的末端定位以及在窗口(2310)中显示的当前(实时)末端定位。
根据一个实施方案，上面多窗口比较使得能够使用下述的导管放置方法：首先使导管在心房中行进，直到如窗口(2320)(图19B)中可见的，P波达到其最大幅值，并且然后将导管拉回P波幅值为其最大幅值的一半大小的部位。P波幅值为其最大幅值的一半大小的这样的部位是上腔静脉的下三分之一(图5中的部位B)的指示。
图20A图示说明根据一个实施方案皮肤参考导联如何可以被用来分析导管导引导联(导联II)的P波段。在其中找到P波自身的P波段通过P波立即领先同一心跳的QRS复合波这样的事实来被特征化。心跳的P波段又在先前的跳动的T波之后。为检测P波段，包括QRS复合波的R峰检测的算法可以被应用。在一个实施方案中，算法包括下述步骤：
检测R峰。
计算R-R间期。
假设R峰之前的R-R间期的一特定百分比是在其中出现P波的间期。该出现P波的间期被限定为P波段。
检测P波段中的P峰，其幅值和极性。
如图11和12所图示说明的，应用进行处理、分析和做出决策的算法。
在一个实施方案中，为应用上述算法，R峰和R-R间期可以在血管内的导联II(即在与用于导引的ECG导联相同的ECG导联上)上被检测。在另一实施方案中，R峰和R-R间期可以使用导联III(皮肤参考导联)来检测。特别地，在图20A中的导联III(2410)上的R峰检测可以被用来触发导联II上的ECG波形的任一段的分析，包括图20A中的P波段(2420)的分析。还可能的是，如果导联II的信号质量允许，使用在导联II自身上检测的R峰(2430)来触发导联II波形的处理。在其他实施方案中，其他导联可以被用来实现针对与用于导管导航和末端定位的导联不同的导联的触发。例如，导联I可以可选地被用于导管导航和末端定位。根据一个实施方案，装置同样允许导联I用于导管导航和末端定位，然而导联II适用于许多临床设置。注意的是，在一个实施方案中，上述触发可以针对由同一导联检测到的波形上的峰进行。同样，在一个实施方案中，导联II上检测到的峰可以被用来触发导联I的分析。因此，考虑这些和其他变体。
如本文所介绍的，不论哪个ECG导联被用来触发分析并且哪个ECG导联被用于导管导航和定位，触发对不同于被用于导管导航和定位的ECG导联的一个ECG导联的分析，在许多实际情况中是有用的。如将在图20B-图20E中(并且尤其是在图20E中)可见的，在导联IIECG信号包括大于期望的信号噪声量的情况下，对稳定无噪声导联(例如导联III)的触发改善处理其他导联的不同段(例如用于导管导航和定位的血管内的导联II)的能力。由于使用者手动处理的导联II连接，有噪声的导联IIECG信号在实际设置中相当频繁地出现。如下面将会看到的，其他情形可以受益于本文所介绍的触发概念。
图20B图示说明参考皮肤导联III(2410)上检测到的R峰和对应的R-R间期如何触发导航导联II上的PQRS段(2430)的分析。如本文所描述的，ECG导联II的P波段和QRS复合波可以被单独地或者相互以某种关系地被分析，从而预测导管末端在脉管系统中的定位。在图20B所示的情况下，P波具有大的正幅值，该正幅值等于R幅值并且也为双极的(具有负第一段)。在这样的情况下，如果通过使用算法并非为不可能的，导联II自身上的R峰的检测是非常困难的。如本文所介绍的，基于参考导联III(2410)上检测到的R峰的检测触发导联II(2430)的ECG波形分析，允许导管末端定位的P波段特征的变化的检测和处理。由于在导联II上清楚地检测R峰的难度，导联II的这样的算法ECG波形分析在图20B中所示的情况下否则将会是困难的。
图20C图示说明在心律失常的患者的情况下，对一个导联的R峰(例如导联III(2420)的R峰)的触发，如何可以被用来触发导管导航导联II(2440)上的P波段的分析。一般地，如在图20C和20D中可见的，P波段不出现在心律失常患者的皮肤ECG导联中。然而，随着导管接近窦房结和腔静脉-心房接点，导管导航和末端定位导联(例如导联II)可以检测P波段中的相对更高水平的电活动。随着导管末端通过窦房结并且进入右心室，P波段中的电活动(能量)的水平进一步增加。因为导航导联II的P波段上的该增加的电活动的最高水平无法被预测，例如P波幅值可以比导联II上的R波幅值更大，触发对皮肤ECG导联的R峰的所述P波段的分析为P波检测以及随后的导管末端位置和定位检测提供适合的方案。
图20D图示说明在心律失常患者的情况下，ECG导联II和III二者上的P波缺失。在图20D中，导联II被连接到患者的右臂上的皮肤电极，并且导联III被连接到患者的左臂上的皮肤电极。导联III(2410)上的R峰在该图中被描绘，并且示出导联II上的可辨识的P波的缺失的对应段被示为(2450)。
图20E图示说明导管导航导联(例如导联II)是有噪声的或者为非稳定并且R峰的检测和对应的P波的检测因而是困难的情况。在这种情况下，如之前的，检测在稳定参考导联(例如皮肤导联III)上的R峰(2410)通过上述的触发保持在噪声更多的导管导航导联上找到并分析P波段(2460)的能力。
图20F图示说明另一实施方案，其中两个导联(在该实施例中为导联I和II，参见图18A)被用来检测同时的对应的ECG波形(2470)和(2475)，并且与参考导联(导联III)的附加同时的ECG波形(2480)一起以三角方式求出导管末端的位置。特别地，通过同时观看导联I和II并且使用其相关性(或者其不存在相关性)来减少噪声并且更准确的确定P段的变化、QRS段的变化以及P波和QRS复合波之间的相对变化，导管末端的基本上准确的定位可以被确定。
图21A和21B图示说明在心律失常的情况下，根据一个实施方案的关于用来使用P波段和/或其与QRS复合波的关系进行导管导航和末端定位的算法的细节。
具体地，图21A图示说明针对两个皮肤ECG导联(使用皮肤电极)的ECG波形。在图21A中，在一个实施方案中，具有其对应的R峰(2510)的导联III使用皮肤左臂电极被检测，并且示出缺少P波(2520)的导联II使用皮肤右臂电极被检测，二者都与皮肤左腿电极相比较。先前地，示出这些典型的心律失常ECG波形的患者不会被认为是使用基于ECG的方法进行导管导航和末端定位的候选者。曾被确信的是，因为P波不出现在皮肤层面，ECG方法无法被用来确定腔静脉-心房接点处的导管末端定位。图21A由此图示说明这样的情形，其中皮肤参考导联(2510)的R峰可以被用来计算特征以及在不存在P波的部位处的导航导联上的P段(P波)的能量。
更加具体地，图21B图示说明如利用结合图20A-20E所描述的装置获得的ECG波形，并且示出利用本文所描述的装置和方法，甚至是心律失常的患者也可以使用基于ECG的导管导航和末端定位来治疗。由于在图11和图12中所述的处理算法，与现有技术相比时，从导联II上的导管末端获得的ECG信号更准确并且具有更少噪声。因此，当导管末端位于窦房结附近时，P波段(2530)中的变化成为可视的。如由生理所证实的，它们响应于右心房的随机电活动。如由P波段(2530)所图示说明的，该随机电活动及其变化可以利用本文所介绍的装置被检测到。该随机电活动一般在达到皮肤和导联III时就抵消了，并且因而难以或者不可能由现有技术的ECG方法来检测。
有时，上述右心房的随机电活动也会是非常微弱的，并且甚至是在导管末端处，需要诸如本文所介绍的装置对其进行检测。通过观察和/或分析导管导航导联上的P波段的变化，导管的末端定位可以被映射，例如，映射到上腔静脉中的部位(微弱的、低能量或没有P波)，映射到腔静脉-心房接点处的部位以及映射到右心房中的部位。图21B图示说明参考导联(例如皮肤导联III)上的R峰如何可以在存在P波段(2530)的部位，触发导航导联(例如血管内的导联II)上的对应P波(P段)的分析。
除了图11和图12中所描述的那些之外，要理解的是，在放置导管或其他血管内的设备方面可以使用其他的决策算法，例如与如从电图谱计算的电能水平相关的那些。例如，一个标准规定在对应于SVC的下三分之一的部位，从血管内的电图计算的平均电能高达从皮肤层面血管内的电图(例如从诸如导联III的对应导联中的皮肤心电图)计算的平均电能的两倍。
除了结合图11和图12在上面公开的算法之外，定向能量的概念以及基于这一点做出决策的概念在本文也被介绍。例如，如在图18B中的(2250)和图18C中的(2255)可见的，P波为单极的，即具有单极性，该极性为正。相比而言，图18D以(2260)和图18E以(2265)图示说明双极P波，即既具有负分量又具有正分量的P波。图18F以(2270)图示说明具有单极的P波段的P波段，但相比于图18B和图18C中所示的P波段的极性具有相反的极性。
根据爱氏三角(图18A)，P波段中的极性的上述变化归因于导管末端相对于窦房结的定位以及皮肤电极的定位。在本文图示说明的情况下，当导管从上腔静脉导航通过腔静脉-心房接点、通过右心房并且进入下腔静脉，P波段的极性相应地改变。
根据一个实施方案并且鉴于上述，通过以下内容导管末端定位可以被确定：针对检测到的P波由本文描述的装置(例如导管放置系统)确定正能量值和负能量值。根据本文所述的能量计算算法，正P波能量值被确定，但是仅仅是针对P波的正值(即，高于ECG基线的值)。相应地，根据本文所述的能量计算算法，负P波能量值被确定，但是仅仅是针对P波的负值(即，低于ECG基线的值)。根据本实施方案所确定的这些能量值(正和负)在本文也被称为“方向性能量”值，因为它们与导管末端的方向和定位有关，在该处，P波正通过与相应的ECG导联(如上面所论述的血管内的导联II)可操作的连接的适当的传感器被检测。
根据一个实施方案，上面所描述的P波方向性能量可以被用来导引导管的导航并且用于定位导管的末端。特别地，在一个实施方案中，考虑标准爱氏电极配置，其中右臂电极检测导管末端处的血管内的ECG信号(如上面结合图20A-图20E所描述的)。注意的是，其他电极配置也是可能的。如果P波能量基本上是全部为正的，则导管末端被认为是位于窦房结之上的，例如在上腔静脉中。如果P波包括正能量和相对少量的负能量，但是正能量相对于R波能量是较小的(例如在图18D中的(2260)可见的)，导管末端可以是位于腔静脉-心房接点。如果P波段相对于其正能量包括大量的负能量，并且正能量与R波能量是可比的(例如在图18E中的(2265)可见的)，则导管末端可以处于右心房中。如果P波包括基本上为全部的负能量(如在图18F中的(2270)可见的)，则导管末端正在接近下腔静脉或者在下腔静脉中。以这种方式，本文所介绍的方向性的能量由本文所描述的本方法使用来进行导管导航和末端定位。
图22A-图22D以及图23A-图23B图示说明关于根据示例性实施方案的连接器的各种细节，该连接器允许由单个操作者在无菌区中使用本文所描述的装置和方法。
特别地，图22A示出连接体(2915)，该连接体(2915)包括磁性吸引性质以及具有导电性质的表面。连接体(2915)电气连接到两个连接器(2910)和(2920)。连接器(2910)被连接到无菌设备/适配器(2905)的一端。无菌设备(2905)的另一端可以被连接到无菌导丝或探针，或者连接到如上面进一步描述的无菌含盐液适配器。连接器(2920)可以附接于被连接到在本文的图1A中所图示说明的装置的ECG线缆的一端或者为该ECG线缆的一端的自身。
连接体(2915)的表面可以以数种方式被实现。在一个实施方案中，磁性件被建入具有导电表面的壳体中。磁性件将电气连接器(2910)和(2920)吸引到金属表面并且将它们锁定在该表面上，由此在连接器(2910)和连接体(2915)的导电表面之间建立电气接触，并且在连接体(2915)的导电表面和另一电气接触体(2920)之间建立另一电气接触。
连接体2915图示说明一种类型的连接器，该种类型的连接器可以由单个操作者在无菌区中与本文描述的方法一起使用。因此，在一个实施方案中，导管放置过程开始之前在非无菌区中放置连接体(2915)，以便其可以在该过程期间由单个操作者触及。然后，仍为非无菌的操作者将非无菌连接器(2920)的一端连接到ECG线缆并且将图22A中示出的连接器端“落(drop)”到连接体2915的表面上。由于包括在连接体(2915)中的磁性件，连接器(2920)被吸引到连接体的导电表面并且附于该表面。ECG线缆的一端可以为ECG导联自身，由此简化流程，其中连接器(2920)被附接到ECG线缆的该端或者被ECG线缆的该端所包括。
在该过程期间，单个操作者是无菌的。操作者打开无菌包装，连接器(适配器)(2910、2905)被装于该无菌包装，以带有无菌手套的手握持无菌连接器端(2915)并且将无菌连接器落到连接体(2915)的导电表面上。与连接器(2920)类似地，连接器(2910)通过内建的磁性件被磁性地吸引到连接体(915)，这将连接器(2910)固定在连接体的导电表面上。使用该方法，在无菌电气连接器(2910)和非无菌连接器(2920)之间可以建立电气连接而不破坏无菌区。再者，该方法可以被单个操作者使用并且使得该单个无菌操作者能够使用本文所描述的装置。
图22B图示说明连接器的另一实施方案，其中连接体(2930)直接连接到丝或者是ECG线缆(2935)的一主要部分。该实施方案简化上面结合图22A所描述的方法，因为在无菌过程期间，只有连接到无菌适配器(2905)的无菌连接器(2925)必须被落到连接体(2930)的导电表面(2930)上。
图22C图示说明连接体的另一实施方案，其中无菌适配器(2905)的连接器(2940)类似于上面结合图22A描述的适配器(2905)和连接器(2910)。在导管放置过程期间，无菌操作者使无菌连接器(2940)落入连接体，或者配接部件(2945)。配接部件(2945)包括将连接器(2940)接纳于其中的杯体。磁性件被建入到杯体中，该磁性件将连接器(2940)吸引到杯体中以将其固定于杯体中。同时，杯体确保电气连接。配接部件(2945)可以为ECG线缆(2950)的一主要部分(例如ECG导联的一端)，用于连接到ECG线缆的丝一端或者一些其他适合的配置。用于使用配接部件2945的方法与结合图22B描述的方法类似，其中区别在于，杯体(2945)具有使连接器(2940)伸入(suckin)的能力，以进行相对地固定凸/凹型连接。正如结合图22A、图22B和图22D描述的实施方案的情况，用于连接体的形状和材料可以改变，而仍确保针对相互连接于其中的部件的适当电气接触。
图22D图示说明与结合图22C描述的连接体配置类似的连接体配置，除了包含用于与连接器(2955)可操作地连接的磁性件的杯体(2960)之外，该连接体配置在相对端上包括连接器(2965)，ECG线缆夹可以被附接到该连接器(2965)。这样，在放置过程期间，通过使用被提供有ECG线缆的夹，无菌操作者可以将连接器(2965)连接到商业上可获得的ECG线缆。随后，与结合图22C描述的方法类似的，在无菌过程期间，无菌操作者使无菌连接器(2955)落入杯体(2960)。
图23A图示说明根据一个实施方案的可操控的无菌适配器(3010)的细节，例如包括刚性塑料的增强无菌连接器部件(3020)。不是如图22C和图22D中那样将无菌连接器部件(3020)落入配接部件(3030)，而是无菌操作者可以使用无菌适配器(3010)的刚性连接器部件(3020)来进行操控(例如推动、转动等)使其进入配接部件。在一个实施方案中，配接部件(3030)包括内建磁性件来吸引连接器部件3020。在另一实施方案中，配接部件(3030)不包括磁性件，而是具有使连接器部件(3020)适配到其中的适当尺寸和形状，从而在二者之间建立适当的电气接触。
图23B图示说明根据一个实施方案的可操控的连接器部件(3040)，该可操控的连接器部件(3040)可以被推入简单的配接部件(3050)并且与配接部件(3050)可操作地连接而无需磁性件。除了已经被示出和讨论的内容之外，其他形状对于连接器(3040)及其配接部件(3050)(例如，轨道或螺丝)是可能的。
要理解的是，可以使用上面所论述的连接器实施方案的任何适当的组合。例如，图23B的可操控的连接器可以包括如图22D中所示的配件部件那样的配接部件。
图24A-图24F图示说明根据一个实施方案的导管导航的各种细节。如所示出的，这些附图中的每个包括两个显示窗口：示出ECG波形的第一窗口，以及示出心脏的表征或图标和附加部位图标的第二窗口，该附加部位图标指示第一窗口中的ECG波形所对应的ECG信号的测量点。在一个实施方案中，使用上面所描述的算法和方法来进行ECG波形和部位图标之间的映射。两个显示窗口可以被单独使用或者一起使用。在一个实施方案中，两个显示窗口在图形用户界面(图1A)上被同时示出，从而允许操作者使所观察的ECG波形(一个或多个)与导管末端定位相关。在另一实施方案中，只有心脏和部位图标窗口被示出，以便简化用户界面。
部位图标可以包括数个可能的配置中的一个或更多个来示出可识别的部位，包括用于示出在特定方向上的行进的箭头、点、十字、星形等。这些图标中的每个可以包括不同的颜色来强调部位关联性。在另一实施方案中，不同的声音可以与可识别的末端定位中的每个相关联。识别末端定位的声音和图标可以一起使用或单独使用，来帮助使用者在患者脉管系统中对导管进行导航以及定位该末端。
在一个实施方案中，采用简化的用户界面，其中只有心脏图标和对应的部位图标(一个或多个)被显示。在该实例中，ECG波形和部位映射后的计算对使用者是不可见的。因此，本文所描述的装置可以用于导航和末端定位而不需要ECG波形的使用者解释。仅具有心脏和导管末端部位图标的简化用户界面可以如例如在图25B中所图示说明的实施方案中所示的那样被使用。
更具体地，图24A图示说明对应于在身体较上部分中胸腔之外的导管末端定位的ECG波形：皮肤参考ECG导联III(3110)和血管内的导管导航ECG导联II(3115)。在图标显示窗口中，心脏图标(3125)被显示并且部位图标(3120)示出导管正朝向胸腔移动。在另一实施方案中，箭头形部位图标(3120)可以以十字、点或者任何其他适合的图标来替换，示出上腔静脉上方和上腔静脉之外的部位。
根据一个实施方案，只有算法检测到导航ECG导联II中的变化，箭头形部位图标(3120)才由装置进行显示，该变化支持导管末端正朝向心脏移动的事实，例如电能中的稳步增加以及具有正方向性能量的P波，指示末端正接近窦房结。如果在导管行进通过脉管系统时，算法没有检测到血管内的ECG信号的电能中的稳步增加，则仅在上腔静脉的上方和上腔静脉之外的部位显示点、星、十字或者任何其他适合的部位图标。除了图形图标之外或者替代图形图标，与这些部位和情况中的每个相关联的声音可以被播放。
图24B图示说明对应于参考导联的ECG波形(3110)以及在对应于上腔静脉的部位处的导管导航导联的ECG波形(3115)。图标显示窗口示出心脏图标(3125)和指示心脏图标上的上腔静脉的点形的部位图标(3130)。如上面进一步描述的，该部位由装置基于ECG波形(3110)和(3115)来确定。如在图24A中的，当导管末端如由检测到的ECG波形所指示的达到该部位时，任何适合的图标形状和颜色可以被使用和/或声音或曲调可以被播放。
图24C图示说明对应于参考导联的ECG波形(3110)以及在对应于上腔静脉的下三分之一的部位处的导管导航导联的ECG波形(3115)。图标显示窗口示出心脏图标(3125)和指示心脏图标上的上腔静脉的下三分之一的点形的部位图标(3140)。如上面进一步描述的，该部位由装置基于ECG波形(3110)和(3115)来计算。如在图24A中的，当导管末端如由检测到的ECG波形所指示的达到该部位时，任何适合的图标形状和颜色可以被使用和/或声音或曲调可以被播放。
图24D图示说明对应于参考导联的ECG波形(3110)以及在对应于腔静脉-心房接点的部位处的导管导航导联的ECG波形(3115)。图标显示窗口示出心脏图标(3125)和指示心脏图标上的腔静脉-心房接点的点形的部位图标(3150)。如上面进一步描述的，该部位由装置基于ECG波形(3110)和(3115)来计算。如在图24A中的，当导管末端如由检测到的ECG波形所指示的达到该部位时，任何适合的图标形状和颜色可以被使用和/或声音或曲调可以被播放。
图24E图示说明对应于参考导联的ECG波形(3110)以及在对应于右心房的部位处的导管导航导联的ECG波形(3115)。图标显示窗口示出心脏图标(3125)和指示心脏图标上的右心房的点形的部位图标(3160)。如上面进一步描述的，该部位由装置基于ECG波形(3110)和(3115)来计算。如在图24A中的，当导管末端如由检测到的ECG波形所指示的达到该部位时，任何适合的图标形状和颜色可以被使用和/或声音或曲调可以被播放。
图24F图示说明对应于在身体较低部分中胸腔之外的导管末端定位的ECG波形：皮肤参考ECG导联III(3110)和血管内的导管导航ECG导联II(3115)。在图标显示窗口中，心脏图标(3125)被显示并且箭头形部位图标(3170)示出导管正移动离开胸腔，例如朝向下腔静脉移动。在另一实施方案中，箭头形部位图标(3170)可以以十字、点或者任何其他适合的图标来替换，示出右心房下方的部位。
在一个实施方案中，只有算法检测到导航ECG导联II中的变化，箭头形部位图标(3170)才由装置进行显示，该变化支持导管末端正移动离开心脏的事实，例如电能中的稳步减少以及具有负方向性能量的P波，指示末端正移动离开窦房结。如果导管行进通过脉管系统时，算法没有检测到血管内的ECG信号的电能中的稳步减少，而是检测到负P波，则仅在右心房的下方和右心房之外的部位显示点、星、十字或者任何其他部位图标。除了图形图标之外或者替代图形图标，与这些部位和情况中的每个相关联的声音可以被播放。
图25A图示说明移动电话(3210)、平板电脑或者其他适合的手持或便携式设备的图形用户界面上的显示窗口。特别地，移动电话的用户界面被示出显示两个ECG导联的波形(3220)：参考导联和导管导航导联。移动电话或其他适合的设备在一个实施方案中被保持为水平位置，从而显示ECG波形的一更长的时间(更多心脏周期)。如果显示设备在实时显示模式下，则每次设备被转换为水平时，显示器自动切换来示出ECG波形。在另一实施方案中，一次仅显示一个ECG导联。在又另一实施方案中，三个或更多个导联可以被同时显示。如在本发明的实施方案中所描述的，显示设备的屏幕的另一实施方案可以被实时地分割来描绘一(当前部位)显示窗口和一定格(参考部位)窗口来允许更容易的评估ECG波形变化。图1A中所示的装置与使能结合图25A-图27B所示出和描述的功能的移动电话(3210)之间的两路相互作用，在一个实施方案中可以通过图1A中所示的无线连接部件150来实现。要理解的是，移动电话(3210)被配备有对应的无线连接功能，从而如本领域的技术人员所理解的使能二者之间的通信。
图25B图示说明基于图24A-图24F中所描述的导航界面，显示在移动电话(3210)或其他适合的手持/便携式设备的屏幕上的简化用户界面(3230)。当在实时显示模式下时并且如果显示设备被垂直置放，则设备自动显示图25B中示出的简化用户界面。当在实时显示模式下时，设备在以下两种情况之间自动地来回切换，即当设备被保持为水平时显示图25A中所图示说明的ECG波形，以及当设备被保持为垂直时显示图25B中所图示说明的导航用户界面。
图26图示说明在一个实施方案中，移动电话(3310)、平板电脑或类似设备的触控屏幕上的缩放和滚动功能。使用者可以使用两个手指(3320)来对ECG波形进行放大和缩小，以提供更好的可视化。使用手指和触控屏幕还可以实现ECG波形记录的滚动。
图27A图示说明在一个实施方案中，使用移动电话(3410)、平板电脑或者其他适合的手持/便携式设备，传送ECG波形和/或简化的用户界面以及患者数据到另一计算机或设备的能力。传送界面由(3420)图示说明。这样的传输可以由移动电话(3410)通过Wi-Fi、蜂窝电话或者其他适合的网络实现。
图27B图示说明移动电话(3410)、平板电脑或者其他适合的手持/便携式设备的图形用户界面，该图形用户界面允许患者数据(3430)、ECG波形(3440)或者取决于设备定向的简化的心脏图标以及界面(3450)的显示，该界面(3450)浏览、控制并且清除一条或更多条患者记录，包括删除、复制到存储器等。
要理解的是，本文所描述的装置、算法和方法可以结合各种各样的环境并且使用各种各样的组件和系统来实施。可以在于2009年9月10递交的、题目为“关于导管的血管内放置的装置和显示方法(ApparatusandDisplayMethodsRelatingtoIntravascularPlacementofaCatheter)”的美国专利申请公开No.2010/0036227中，找到ECG监控系统的一个实施例，使用该ECG监控系统本发明的实施方案可以被实施。可以在于2009年4月21日递交的、题目为“定位中心静脉导管的末端的方法(MethodofLocatingtheTipofaCentralVenousCatheter)”的美国专利申请公开No.2009/0259124中，找到ECG监控系统的另一实施例。前述申请中的每个通过引用被整体并入本文。
可以在于2009年8月21日递交的、题目为“包括ECG传感器和磁性组件的导管组件(CatheterAssemblyIncludingECGSensorandMagneticAssemblies)”的美国专利申请公开No.2010/0222664以及于2010年9月29日递交的、题目为“用于与进行导管的血管内放置的装置一起使用的探针(StyletsforusewithApparatusforIntravascularPlacementofaCatheter)”的美国专利申请No.2011/0015533中，找到可以与本发明的实施方案结合使用的ECG传感器探针的非限制性实施例，这些专利申请中的每个通过引用被整体并入本文。
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 (14)

1.一种用于定位在患者身体中的留置医疗设备的方法，所述方法包括：
在皮肤导联上的第一皮肤ECG波形中检测第一峰；
当所述第一峰被检测到时，触发第二血管内的ECG波形的分析；
在血管内的导联上的第二血管内的ECG波形中检测第二峰；以及
基于所述第二峰的特征，确定所述留置医疗设备的一部分的位置。
2.如权利要求1所限定的用于定位的方法，所述方法还包括：
反复地检测所述第二峰，其中确定位置的步骤还包括：当所述第二峰被反复地检测到，基于所述特征的改变确定所述留置医疗设备的所述部分的所述位置。
3.如权利要求1所限定的用于定位的方法，其中所述第一皮肤ECG波形是通过皮肤放置的第一电极获得的，其中所述第二血管内的ECG波形是通过第二电极获得的，所述第二电极可操作地连接于至所述身体内的一部位的导电路径，其中所述留置设备包括导管，并且其中所述留置设备的所述部分包括所述导管的远侧末端。
4.如权利要求3所限定的用于定位的方法，其中触发第二血管内的ECG波形的分析的步骤还包括：
通过所述第二电极来触发分析，所述第二电极以在血管内的方式被设置在所述身体内。
5.如权利要求1所限定的用于定位的方法，其中检测所述第一峰和检测所述第二峰的步骤还包括：
在通过皮肤放置的第一电极获得的第一皮肤ECG波形中检测第一峰，所述第一峰包括R波峰；以及
在第二血管内的ECG波形中检测第二峰，所述第二峰包括P波峰。
6.如权利要求1所限定的用于定位的方法，所述方法还包括：
在显示器的第一部分上，同时描绘所述第一皮肤ECG波形和第二血管内的ECG波形。
7.如权利要求1所限定的用于定位的方法，所述方法还包括：
在显示器的第一部分上，同时描绘所述第一皮肤ECG波形和第二血管内的ECG波形的当前视图；以及
在显示器的第二部分上，描绘所述第一皮肤ECG波形和第二血管内的ECG波形的早先视图。
8.如权利要求7所限定的用于定位的方法，所述方法还包括：
在显示器的一部分上，描绘表征所述留置医疗设备的所述部分在所述身体中的位置的部位图标；以及
根据反复地确定所述留置医疗设备的所述部分的所述位置，更新所述部位图标的描绘。
9.如权利要求8所限定的用于定位的方法，其中描绘所述部位图标的步骤还包括：
在所述患者的心脏的表征图像上，描绘所述部位图标。
10.如权利要求1所限定的用于定位的方法，所述方法还包括：
通过无线传输在移动电话或手持设备的显示器上描绘所述第一皮肤ECG波形和第二血管内的ECG波形中的至少一个。
11.如权利要求1所限定的用于定位的方法，其中触发所述第二血管内的ECG波形的所述分析的步骤是由导管定位装置的处理器自动地执行的。
12.如权利要求1所限定的用于定位的方法，其中，所述第一皮肤ECG波形中的第一峰是R波峰，并且由于心律失常在所述第一皮肤ECG波形中P波峰不存在，但在所述第二血管内的ECG波形中存在P波段的至少一部分。
13.如权利要求1所限定的用于定位的方法，其中所述第二峰包括P波峰，并且其中确定所述留置医疗设备的一部分的位置的步骤还包括：
当所述P波的幅值是正的并且在正幅值上不断增大，确定所述留置医疗设备的所述部分高于所述患者心脏的窦房结并且朝向所述患者心脏的窦房结移动。
14.如权利要求1所限定的用于定位的方法，其中所述第二峰包括P波峰，并且其中确定所述留置医疗设备的一部分的位置的步骤还包括：
当所述P波的幅值是负的并且在负幅值上不断增大，确定所述留置医疗设备的所述部分低于所述窦房结并且远离所述窦房结移动。
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