CN102802514B - 导管末端定位设备 - Google Patents

导管末端定位设备 Download PDF

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CN102802514B
CN102802514B CN201080035659.0A CN201080035659A CN102802514B CN 102802514 B CN102802514 B CN 102802514B CN 201080035659 A CN201080035659 A CN 201080035659A CN 102802514 B CN102802514 B CN 102802514B
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heart
intravascular device
spectral power
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S·格伦沃尔德
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Bard Access Systems Inc
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    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
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    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A61B5/353—Detecting P-waves
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61B5/6852—Catheters
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/6876—Blood vessel
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    • A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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Abstract

提供一种基于计算机的方法，所述方法用于使用心电图(ECG)信号将血管内设备定位在心脏的内部或附近。所述基于计算机的方法包括：接收与血管内设备相关联的血管内ECG信号，在多个预定时间段期间对所述血管内ECG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，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确定相关联的最大谱功率，将所述最大P波幅值和所述最大谱功率与心脏内部或附近的预定位置相关联，在每个预定时间段内基于所述P波幅值与所述最大P波幅值的比率和所述谱功率与所述最大谱功率的比率来计算所述血管内设备的位置，以及向使用者显示所述血管内设备的位置。

Description

导管末端定位设备
相关申请的交叉引用：本申请要求2009年6月12日递交的美国临时专利申请序号No.61/213,474的优先权，该美国临时专利申请的全部公开内容通过引入被并入本文。
技术领域
本发明涉及一种血管内设备定位。具体地讲，本发明涉及一种用于使用心电图(ECG)信号将诸如中心静脉导管的血管内设备的末端定位在心脏的内部及周围的方法。
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
本发明的实施方案有利地提供用于使用心电图(ECG)信号将诸如中心静脉导管的血管内设备的末端定位在心脏的内部及周围的基于计算机的方法。
根据本发明的一个实施方案，提供一种用于使用心电图(ECG)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。该基于计算机的方法包括：接收与血管内设备相关联的血管内ECG信号，所述血管内ECG信号包括多个波形，每个波形具有至少一P波分量，在多个预定时间段期间对所述血管内ECG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，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确定相关联的最大谱功率，将所述最大P波幅值和所述最大谱功率与心脏内部或附近的预定位置相关联，在每个预定时间段内基于所述P波幅值与所述最大P波幅值的比率和所述谱功率与所述最大谱功率的比率来计算所述血管内设备的位置，以及向使用者显示所述血管内设备的位置。
根据本发明的进一步的实施方案，上述实施方案适于：同时接收与皮肤ECG导联相关联的皮肤ECG信号，所述皮肤ECG信号包括多个波形，每个波形具有至少一P波分量，在所述多个预定时间段期间对所述皮肤ECG信号进行处理，以计算每个预定时间段内的皮肤P波幅值和皮肤谱功率，从所述多个皮肤P波幅值确定最大皮肤P波幅值，并且从所述多个皮肤谱功率确定相关联的最大皮肤谱功率，将所述最大皮肤P波幅值和所述最大皮肤谱功率与心脏内部或附近的预定位置相关联，以及在每个预定时间段内基于所述血管内P波幅值与所述最大皮肤P波幅值的比率和所述血管内谱功率与所述最大皮肤谱功率的比率来计算所述血管内设备的位置。
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，本发明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。本发明能够具有除了描述的实施方案之外的实施方案，并且能够以各种方式实施和实现。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，只要它们不脱离本发明的精神和范围。
附图说明
图1是描绘根据本发明的实施方案的仪器的框图。
图2A、图2B和图2C描绘各种血管内适配器设备。
图3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使用者界面。
图9描绘根据本发明的另一个实施方案的图形使用者界面。
图10A和图10B描绘根据本发明的实施方案的图形使用者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图示说明根据可替换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。
具体实施方式
现在将参照附图对本发明进行描述，在附图中，相似的标号始终表示相似的部分。
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发明受益。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。
在本发明的一方面，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。
在本发明的另一方面，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盐水。在另一个端部，连接线可以与电子模块连接。
在本发明的另一方面，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。
在本发明的另一方面，引入用于分析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。本发明还设想模糊、统计和基于知识的决策制定作为决策支持工具。
在本发明的另一方面，提供有利地简化数据和工作流的解释的使用者界面。在一个实施方案中，所述使用者界面包括简化图形，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，所述使用者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。
在本发明的另一方面，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。
图1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。如果血管进入设备是探针、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，应该使用根据本发明的吊钩或鳄鱼夹适配器。如果血管进入设备是导管，则应该使用盐水来建立通过导管的内腔之一的传导路径。在这样的情况下，应该使用根据本发明的注射器-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本发明所述的算法(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使用者界面(180)。
图2A、图2B和图2C描绘各种血管内适配器设备。
图2A图示说明可以由隔离导电线(255)制成的、具有两个端部的适配器：一个端部与血管进入设备连接(255)，另一个端部与电子模块连接(250)，隔离导电线由铜或不锈钢制成。与血管进入设备连接的端部包括可以具有几种构造的连接器。在一个实施方案中，该连接器是具有弹簧的J夹连接器(230)，所述弹簧在J末端不延伸时用于隔离目的。在另一个实施方案中，连接器是隔离鳄鱼夹(220)。在另一个实施方案中，连接器是导管-注射器适配器(210)。导管-注射器适配器的一个端部(211)可以与导管鲁尔接头(luer)连接。另一个端部(215)可以与注射器连接。金属嵌件(214)，比如，金属环，位于适配器的本体内部，当盐溶液从注射器朝向导管内腔流动时，与盐溶液接触。金属嵌件通过适配器壁与线(212)连接，线(212)又与连接器(250)连接。在一个实施方案中，连接器(250)通过外部隔离件(241)固定，并且插入电子模块中的安全插头。在另一个实施方案中，连接器(250)具有顾及标准ECG线缆连接器的容易的且安全的连接的优化乳头式形状(242)。
图2B图示说明考虑仅在其远侧端(261)收集电信息的新型导丝(260)。该导丝由具有足够好的导电性的导电材料，比如，不锈钢或镍钛诺制成。导丝在其除了远侧端和近侧端之外的整个长度上涂覆有电隔离覆层，比如，适形帕利灵(parylene)覆层。导管具有印刷在其上的长度标记(262)。为无损伤末端(为J末端或者以任何其他无损伤实施方案的方式)的远侧端不被涂覆，并且这顾及了与血液的电接触。近侧端(263)不被涂覆，并且使得连接器(比如，图2中的连接器(220或230))可与导丝电连接。
图2C图示说明导管-注射器适配器的另一个实施方案。塑料片(270)包括可以刚好放入标准导管鲁尔接头或者其内腔中的成形端部(271)。所述形状和材料考虑了端部(271)与鲁尔接头的内壁或内腔之间的良好接触，以使得在处理中，流体可以无泄漏地流动，并且没有空气被引入到内腔中。所述片的另一个端部(272)是可以适合任何标准注射器的鲁尔接头型连接器。适配器本体或内室(273)使鲁尔接头(272)的直径适应内部导管内腔(271)的大小，并且通过室壁(274)中的穿孔提供内室中的导电元件与连接到室外部的线的连接。通过室壁的连接是防水的。当通过适配器注射盐水时，连接(274)创建盐水与外部线之间的防水传导路径。适配器(290)是使两种大小的直径(291)和(292)相互匹配的塑料片。在一个实施方案中，适配器(270)的端部(271)刚好放入适配器(290)的内腔端部(291)，而适配器(290)的另一个端部(292)刚好放入用于放置可植入端口的导管的内腔。
图3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(300)的框图。
患者连接器接口(310)使得可将电引线与患者(305)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(320)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(330)将信号转换为微处理器(340)可读的数字格式。任何数量和构造的微处理器、微控制器、数字信号处理器可以用于实现微处理功能(340)。
在一个实施方案中，微控制器负责控制通过串行接口(370)或者通过无线接口(380)与计算机模块(390)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(340)还从计算机模块(390)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(320)。患者隔离块(350)使电源(360)和串行通信信道(370)与患者接口(310)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(350)可以由变压器和/或耦合器，比如，光耦合器构成。
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水平处记录的心电图类似。
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。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水平处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。
图8描绘根据本发明的实施方案的图形使用者界面。
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冻结波形(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使用者界面。
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使用者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、除去伪像等。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像这样的伪像。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、它们的峰值、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/峰值的最大值和P波峰间幅值的最大值；
12、某个时间段期间的R波幅值/峰值的最大值和QRS复合波峰间幅值的最大值。
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、“峰值检测”；
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、为了滤除伪像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值的频率等；
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。
在可替换实施方案中，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水平处的血管内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。
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。几个传导路径与心脏(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。
本发明的许多特征和优点从详细的说明书是明显的，因此，所附权利要求意图覆盖落在本发明的真实精神和范围内的本发明的所有这样的特征和优点。此外，由于许多修改和变化将容易被本领域技术人员想到，所以不期望将本发明限于所示和所述的精确构造和操作，因此，所有合适的修改和等同形式都可以被诉诸为落在本发明的范围内的修改和等同形式。

Claims (1)

1.一种用于血管内心电图描记法的适配器，所述适配器包括：
构件，所述构件具有两个端部和内腔，以使得当所述端部之一与导管连接并且另一端部与注射器连接时，来自所述注射器的流体通过所述内腔涌入所述导管；以及
金属环，所述金属环沿着所述构件的所述内腔设置并且完全位于所述构件内部以使得所述金属环与所述导管不接触，所述金属环通过密封的电连接与所述构件的外侧连接。
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