CN103189009A - 医疗设备的生物阻抗辅助放置 - Google Patents

医疗设备的生物阻抗辅助放置 Download PDF

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CN103189009A
CN103189009A CN2011800525875A CN201180052587A CN103189009A CN 103189009 A CN103189009 A CN 103189009A CN 2011800525875 A CN2011800525875 A CN 2011800525875A CN 201180052587 A CN201180052587 A CN 201180052587A CN 103189009 A CN103189009 A CN 103189009A
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conduit
limits
electrode pair
resistance value
catheter
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CN103189009B (zh
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D·S·何
D·J·查沃里拉
E·K·伯恩赛德
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    • A—HUMAN NECESSITIES
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • 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
    • A61B5/068—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe using impedance sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00026—Conductivity or impedance, e.g. of tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00331—Steering mechanisms with preformed bends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2051—Electromagnetic tracking systems
    • A—HUMAN NECESSITIES
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M2025/0166—Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
    • A—HUMAN NECESSITIES
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters

Abstract

公开了用于通过生物阻抗测量在患者的脉管系统中引导导管或其他医疗设备到期望的目标部位的系统和方法。在一个实施方案中，目标部位包括这样的导管置放，从而导管的远侧末端邻近心脏被设置，例如右心房和上腔静脉的接合部位。在一个实施方案中，用于引导所述导管的方法包括将导管引入患者的血管，所述导管限定内腔，流体能够通过所述内腔被输注到所述患者的脉管系统。所述导管在脉管系统中朝向目标部位被推进。基于与血管的第一组织表面相关的至少一个电气性质的脉管内检测计算第一阻抗值，来使得所述导管的远侧端相对于目标部位的接近度的确定得以进行。

Description

医疗设备的生物阻抗辅助放置
相关申请的交叉引用：本申请要求2010年10月29日递交的、题为“生物阻抗辅助导管放置(Bioimpedance-Assisted Catheter Placement)”的美国临时专利申请No.61/408,181的权益，该美国临时专利申请No.61/408,181通过引用被全部并入本文。
发明内容
简要概述，本发明的实施方案涉及用于通过生物阻抗测量在患者的脉管系统中引导导管或其他医疗设备到期望的目标部位(target destination)的系统和方法。在一个实施方案中，目标部位包括这样的导管的置放，从而导管的远侧末端邻近心脏被设置，例如右心房和上腔静脉的接合部位(junction)。
在一个实施方案中，用于引导导管的方法包括将导管引入患者的血管，所述导管限定内腔，流体可以通过所述内腔被输注到患者的脉管系统中。导管在脉管系统中被朝向目标部位推进。基于与血管的第一组织表面相关的至少一个电气性质(例如电流和电压)的脉管内检测计算第一阻抗值，来使得所述导管的远侧端相对于目标部位的接近度的确定得以进行。
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是示例性系统的框图，本发明的实施方案可以利用该示例性的系统来实践；
图2是患者和使用图1的系统被插入患者体内的导管的简化视图；
图3是根据一个实施方案的被设置在患者的脉管系统的血管中的图2的导管的部分剖视图；
图4是根据一个实施方案的图1的系统的部分的简化示图；
图5是患者的心脏和周围脉管系统以及图2的导管的简化视图；
图6是根据一个实施方案的包括设置于其中的引导探针的导管的远侧部分的透视图；
图7是根据一个实施方案的包括指向翼的导管的远侧部分的侧视图；
图8是根据一个实施方案的包括两个指向翼的导管的远侧部分的侧视图；
图9A和图9B是部分剖面侧视图，示出根据一个实施方案的设置在血管中并且包括可展开的翅的导管的远侧部分；
图10是部分剖面侧视图，示出根据一个实施方案的设置在血管中并且包括电极对的导管；
图11是根据一个实施方案的设置在静脉中的导管的剖开的底视图；
图12是根据一个实施方案的设置在动脉中的导管的剖开的底视图；以及
图13是根据一个实施方案的设置在患者的脉管系统的血管中的图2的导管的部分剖视图。
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将描述的所述设备的临床医生的方向，而词语“远侧的(distal)”是指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。
本发明的实施方案总地涉及用于将医疗设备(例如外周导入中心静脉置管(“PICC”)或其他导管)引导至符合期望的解剖学上的位置(anatomic location)的系统和方法。具体地，要被论述的特定实施方案描述辅助导管或其他医疗设备在患者的身体的脉管系统内的放置，从而导管的远侧末端邻近心脏被设置，例如，右心房(“RA”)和上腔静脉(“SVC”)的接合部位。在一个实施方案中，导管末端到这样的位置的引导通过使用生物阻抗测量来实现，这可以加强临床疗效并且提高患者安全。因此，在一个实施方案中，可以实现身体阻抗和脉管内解剖学上的位置之间的映射。注意的是，要描述的用于以本文所论述的系统和方法在患者体内放置的导管包括那些限定一个或更多个内腔来进行流体的输注和从脉管系统抽吸流体的导管。然而，应当记住的是，可以使用本文描述的原理放置其他类型的导管和医疗设备。这样，下面的论述不应被认为是以任何方式进行的限定。
简言之，组织阻抗是患者脉管系统中的特定位置现象(location-specific phenomenon)。例如，在胸腔中，不同的心室之间以及心房组织和邻近的组织(包括下腔静脉(“IVC”)和SVC)之间存在可测量的组织阻抗差。事实上，心房组织主要地包括心肌组织，心肌组织呈现相对高的导电性，而由此呈现相对低的阻抗。相反地，脉管组织(例如静脉的区域(IVC和SVC))主要地包括平滑肌细胞，平滑肌细胞比心房组织薄许多并且因此具有相对低的导电性，而由此具有相对高的阻抗。在RA和SVC的接合部位，心房组织和脉管组织彼此接触并且由此限定阻抗“边界区”，在该阻抗“边界区”中相对低的阻抗组织接触相对高的阻抗组织。该区域只是在患者脉管系统中发现阻抗的相对差的位置的一个实例。
根据一个实施方案，系统被公开来使这样的阻抗变化在导管或其他医疗设备在患者的脉管系统中推进期间能够被监控，从而使得导管的远侧末端在期望的目标部位的安置得以进行。在一个实施方案中，除其他部件外，系统包括专用目的的电路、处理器以及用于通过设置在导管的远侧部分上的电极监控脉管内生物阻抗的显示器。本文描述的系统和方法为临床医生提供引导，来辅助通过在导管推进通过脉管系统期间由电极检测的阻抗的反馈导引导管的远侧末端到期望的目标部位。此外，系统可以被用来在导管推进完成之后确认导管远侧末端位置。此外，注意的是，通过本文论述的系统和方法安置的导管仅仅是许多不同类型的导管或其他适合的留置医疗设备之一的代表。
首先参照图1和图2，图1和图2描绘根据本发明的一个示例性实施方案配置的、一般被表示为10的导管放置系统(“系统”)的各种部件。如所示的，系统10一般地包括控制台20、显示器30、超声探测器40、传感器50以及阻抗部件60，这些中的每个下面将进行进一步具体描述。
注意的是，要用来通过阻抗测量引导导管的具体部件在本文中在系统10中被示出，该系统还包括附加导管插入和引导功能，如下面将被论述的，包括预插入基于超声的血管可视化模式和基于磁性的导管末端引导模式。尽管如此，理解的是，除系统10的其他导管插入和推进辅助特征之外，同样在下面论述的基于阻抗的导管引导模式可以被独立地采用。事实上，在一个实施方案中，系统10可以仅包括基于阻抗的导管引导模式。这样，本论述内容仅呈现这样的环境的一个实施例，在该环境下本发明的实施方案可以被实践。
图2示出在将导管72通过皮肤插入部位73放置到患者脉管系统中的过程期间，上面所参照的部件相对于患者70的总体关系。图2示出导管72一般地包括近侧部分74和远侧部分76，在放置完成之后，近侧部分74保持在患者体外，远侧部分76留在患者脉管系统内。系统10被用来将导管72的远侧末端76A最终安置在患者脉管系统中的期望位置上。在一个实施方案中，导管远侧末端76A的期望位置邻近患者的心脏，例如SVC的下三分之一(1/3)部分。当然，系统10可以被用来将导管远侧末端放置在其他位置上。导管近侧部分74还包括毂74A和一个或更多个延伸腿74B，毂74A在导管72的一个或更多个内腔之间提供流体连通，一个或更多个延伸腿74B从所述毂向近侧延伸。
图1和图2的控制台20可以具有各种各样形式中的一种并且可选地容置各种系统部件。处理器22(包括非易失性存储器，例如，举例来说，EEPROM)被包括在控制台20中，来在系统10的操作期间控制系统功能和脉管内阻抗计算，由此用作控制处理器。数字控制器/模拟接口24与控制器20一起也被包括并且与处理器22和其他系统部件二者进行通信，以操控超声探测器40、传感器50、阻抗部件60以及其他系统部件之间的接口连接。
更进一步地，如将被描述的，控制台20的阻抗部件60包括用于测量传递至设置在导管72上的电极的电流的装置。在本实施方案中，用于测量电流的装置包括被实施为采样电路或其他适合形式的安培计64。用于测量跨电极的电压的装置也被包括。在本实施方案中，用于测量电压的装置包括被实施为采样电路或其他适合形式的伏特计66。当然，可以采用其他设备来实现前面所述的装置的功能。如将被描述的，射频(“RF”)或电流源62也被包括，来将电流提供至导管电极。除了这些部件之外，用于使得阻抗脉管内检测得以进行的其他部件也可以被添加到系统10、导管72或者二者。如在图1中所示的，安培计64、伏特计66和RF源62被可操作地连接到处理器22和端口52，以使得其间的互操作性得以实现。注意的是，前面所述的部件可以被设置在不同于控制台20的位置上。
如所述的，系统10还包括端口52，用于控制台部件与传感器50和可选的部件54(包括打印机、储存器介质、键盘、音频扬声器等)的连接。端口52在一个实施方案中为USB端口，然而其他端口类型或端口类型的组合可以被用于本文所描述的该接口连接和其他接口连接。电源连接部件56与控制台20一起被包括来使得到外部电源供应器58的可操作连接得以实现。还可以在具有或不具有外部电源供应器58的情况下，采用电池或其他适合的内部电源供应器57。电源管理电路59与控制台的数字控制器/模拟接口24一起被包括来管控电源使用和分配。
显示器30在本实施方案中被集成到控制台20中并且被用来在导管放置过程期间显示阻抗和其他信息给临床医生。在另一实施方案中，显示器可以与控制台分离。如将可见的，通过显示器30描绘的内容可以根据导管放置系统所处的模式而改变：超声血管可视化、基于磁性的导管引导、基于阻抗的导管引导等。在一个实施方案中，控制台按钮界面32和包括在超声探测器40上的按钮可以被临床医生用来立即调用期望的模式给显示器30，以辅助放置过程。在一个实施方案中，来自多个模式(例如基于磁性的导管引导和基于阻抗的导管引导)的信息可以被同时显示。因此，系统控制台20的单个显示器30可以被用于例如进入患者的脉管系统时的超声引导、导管推进通过脉管系统期间的基于磁性的引导以及导管远侧末端相对于脉管系统内的期望的目标部位的放置的基于阻抗的引导和/或确认。在一个实施方案中，显示器30是LCD设备。
超声探测器40与上面所述的第一模式结合使用，即基于超声(“US”)的血管(例如静脉)的可视化，为导管72插入脉管系统做准备。这样的可视化提供实时超声引导来将导管引入到患者的脉管系统中并且辅助减少与这样的引入典型相关联的并发症，包括意外动脉穿孔、血肿、气胸等。
手持式探测器40包括容置压电阵列的头，该压电阵列用来产生超声脉冲并且在所述头抵靠患者的邻近预期插入部位73(图2)的皮肤被放置时接收该超声脉冲被患者的身体反射之后的反射波。探测器40还包括多个控制按钮，多个控制按钮可以被包括在按钮板上。在一个实施方案中，系统10的模式可以通过控制按钮来控制，由此消除对临床医生要到无菌区域之外来通过使用控制台按钮界面32(图1)来改变模式的需求，该无菌区域在导管放置之前围绕患者插入部位被建立。
这样，在一个实施方案中，临床医生采用第一(US)模式来例如利用针或导引部件，然后利用导管来确定适合的插入部位并且建立脉管进入。临床医生则可以通过探测器按钮板上的按钮推动来准确无误地(seamlessly)切换到另一模式，例如基于磁性的导管引导或基于阻抗的导管引导，而无需到无菌区域之外。这些后面的模式则可以被用来辅助导管72通过脉管系统朝向预期目标部位的推进。
图1示出探测器40还包括按钮和存储器控制器42来操控按钮和探测器操作。在一个实施方案中，按钮和存储器控制器42可以包括非易失性存储器，例如EEPROM。按钮和存储器控制器42与控制台20的探测器界面44可操作的连通，该探测器界面44包括用于与探测器压电阵列接口连接的压电输入/输出部件44A以及用于与按钮和存储器控制器42接口连接的按钮和存储器输入/输出部件44B。注意的是，控制台按钮界面和探测器界面在一个实施方案中可以包括触控屏幕、语音命令部件或者其他适合的功能部件来使得对临床医生来说方便的系统控制得以实现。
在磁性感测模式下的操作期间，传感器50被系统10使用来检测由包括在可移除地接纳在导管72的内腔中的探针中的磁性元件产生的磁场。如在图2中可见的，传感器50在导管插入期间被放置在患者的胸部上。例如通过使用外部身体标记，传感器50被放置在患者的胸部上预先确定的位置，来使得如上所述的被设置在导管72中的探针磁性元件的磁场在导管通行通过患者脉管系统期间能够被检测。探针磁性组件的磁性元件是与导管72的远侧端76A(图2)共端的(co-terminal)，从而传感器50所检测的磁性元件的磁场提供关于导管远侧端在脉管系统中通行期间导管远侧端的位置和定向的信息给临床医生。
更具体地，如图1所示，传感器50通过线缆和端口52中的一个或更多个可操作地连接到系统10的控制台20。注意的是，在传感器和系统控制台之间还可以使用其他连接方案而不受限。如刚刚所描述的，磁性元件被用在探针100中来使得导管远侧端76A(图2)相对于放置在患者的胸部上的传感器50的位置能够是可观察的。在磁性引导模式期间，由探针磁性元件的传感器50进行的检测被图示地显示在控制台20的显示器30上。
以这种方式，放置导管的临床医生能够大体上确定患者脉管系统中的导管远侧端76A相对于传感器50的位置和/或定向(例如，导管72的远侧末端76A正在指向的方向)并且检测何时导管正出现错位，例如导管沿不期望的静脉的推进。在一个实施方案中，磁性组件可以使用下面所述的美国专利的一个或更多个的教导被跟踪：No.5,775,322、No.5,879,297、No.6,129,668、No.6,216,028以及No.6,263,230。前面所述的美国专利的内容通过引用被整体并入本文。再次注意的是，包括在控制台20或超声探测器40上的按钮可以被用来在超声模式、基于磁性的导管引导模式或者基于阻抗的导管引导模式期间控制系统功能。
注意的是，本文所描述的系统在一个实施方案中可以包括附加的功能，其中导管远侧末端相对于窦房(“SA”)或患者的心脏的其他电脉冲发射结的接近度的确定可以被确定，由此提供将导管远侧末端准确地放置在邻近所述结的期望位置上的增强的能力。在本文中也被称为“ECG”或“基于ECG的末端确认”，系统的该附加模式使得源自SA结的ECG信号的检测得以进行，从而将导管远侧末端放置在患者脉管系统中的期望位置上。注意的是，如本文所描述的，ECG模式可以与系统的其他模式(即，下面将进一步描述的基于超声的导管跟踪、基于磁性的导管跟踪以及基于阻抗的跟踪)准确无误地结合。关于该ECG模式和上面所描述的其他模式的进一步的细节可以参见2010年9月29日递交的、题为的“与用于导管的脉管内放置的设备一起使用的探针(Stylets for use with Apparatus forIntravascular Placement of a Catheter)”的美国专利申请公开No.2011/0015533，该美国专利申请公开No.2011/0015533通过引用被整体并入本文。
图2示出导管72通过绳缆78可操作地连接到位于患者的胸部上的传感器50，其中该传感器又通过线缆可操作地连接到控制台20及其所包括的部件。以这种方式，电极可操作地连接到RF源62、安培计64、伏特计66、处理器22、显示器30以及在其操作期间所采用的其他系统部件。
如图2中可推知的，图3示出设置在患者70的血管80中的导管72的远侧部分76。如所示的，远侧部分76包括电极阵列90，电极阵列90例如包括第一和第二电极90A和90B，第一和第二电极90A和90B可操作地连接到(例如在导管壁中向近侧纵向地延伸的)导线等并且可操作地连接到绳缆78(图2)，以将电极阵列90的电极90A、90B与RF源62(图1)可操作地连接。理解的是，电极阵列和构成的电极可以以各种各样的方式来配置并且电极的形状、数目、位置以及类型可以不同于本文所描绘和描述的内容。例如，电极可以邻近可移除地接纳在导管的内腔中的探针的远侧端而被包括。因此，考虑这些和其他可能的配置。
图4根据一个实施方案描绘直接参与测量血管的组织表面92的阻抗的各种部件以及相互操作关系的简化示图。这些部件包括RF源62，RF源62提供RF电流到电极阵列90，电极阵列90包括围住(bound)被评估组织表面92两侧的电极90A和90B。RF源62提供的电流的幅值可以通过安培计64来测量并且传送到控制台20的处理器22。跨被评估组织的两个电极90A和90B之间的电压幅值差可以通过伏特计66来测量并且传送到处理器22。
在系统10和导管72如图3和图4所示那样被配置的情况下，导管72可以通过以下方式被准确地安置在患者脉管系统中：首先将导管设置在脉管系统的血管中，从而邻近导管的远侧末端76A的电极阵列90邻近组织表面(例如图3的组织表面92)，由此在电极阵列90和血管80的组织表面92之间提供电连通。在一个实施方案中，如图3中的，这样的电连通通过将导管72安置在血管80中以使电极90A、90B物理地接触血管80的组织表面92来实现。RF源62所产生的RF电流则可以被提供到电极阵列90。在一个实施方案中，电流包括预先确定的频率并且具有相对低的功率。由此，在导管的远侧部分76被抵靠组织表面92设置(即在本实施方案中并且如图3中所示的血管80的内壁)的情况下，RF电流被提供到电极阵列90并且通过安培计64来测量。跨组织表面92的电极90A和90B之间的最终电压差通过伏特计来测量。RF电流和电压的幅值被传送到处理器22。
在分别从安培计64和伏特计66接收到电流和电压数据时，处理器可以根据如下的公式来计算被评估组织表面的区域中的阻抗(本文中也被称为生物阻抗)：
阻抗(Z)＝电压(V)/电流(I)。    (1)
这样，在本实施方案中，具有嵌入式软件的处理器包括适合的控制算法来对电流和电压数据(以及任何其他生物物理参数)进行采样，以自动地计算生物阻抗。如由处理器22或其他适合的系统部件计算的最终阻抗数据可以被描绘在显示器30上，来由临床医生进行观察。此外，音调或其他适合的信号可以由扬声器54或其他适合的输出装置输出，从而提供附加反馈给临床医生。例如，在达到RA和SVC的接合部位(组织阻抗中出现明显变化的区域)时，显示器可以指示所检测的RA/SVC接合部位的位置，并且音频扬声器54可以发出预先确定的音调来指示期望的解剖学上的目标位置。
上述过程可以在导管远侧末端76A在血管中被推进时被实时重复，从而根据导管72的远侧末端的当前位置提供关于所计算的阻抗值的实时更新。例如，针对血管中导管远侧末端的第一位置的第一阻抗计算值被计算并且显示，然后针对第二远侧末端位置的第二阻抗计算值被计算并且显示。这样的过程可以被反复地执行并且最终阻抗值被比较，从而使得临床医生能够分辨出何时导管远侧末端被设置在期望的目标位置，例如，举例来说，RA/SVC接合部位。
图5示出患者的心脏96，包括这样的区域(包括SVC98、RA/SVC接合部位100以及RA102)在所述区域中以及邻近所述区域具有不同阻抗。SVC98例如包括相对高的阻抗，例如在一个实施例中为约130-140欧姆(ohm)，而RA/SVC接合部位100为相对较低的阻抗，例如具有约118欧姆。RA102具有更低的阻抗，例如在一个实施例中为约84欧姆。这样的组织阻抗值中的基于位置的变化可以被系统10用来确定导管72的电极阵列90的位置(图1、图3)。此外，对从电极阵列90到导管的远侧末端76A的距离的获知使得导管末端的位置在脉管系统中能够被确定，由此使得其准确的放置在期望的目标位置上得以实现。注意的是，上述阻抗值是出于图示说明的目的而不应被认为是限制性的。
因此，鉴于上述内容，针对血管中连续导管远侧末端定位的后续阻抗计算值的比较可以指示相对于期望的目标位置的接近度。例如，第一和第二阻抗表面之间的阻抗值的相对小的减小可以指示电极已经从SVC98通过到达RA/SVC接合部位100(图5)，而第一和第二内部表面之间的相对较大的阻抗减小可以指示电极已经从SVC通过到达RA102。这样的或其他适合的过程可以被扩展为使用多个电极阵列、多个阻抗读数等。在一个实施方案中，例如仅有单个阻抗读数可以是用于确定导管远侧末端相对于RA/SVC或RA的位置所必需的。
如上面所指出的，给定导管位置处的阻抗值的测量，其后导管移动以及在新位置处的后续测量，可以被反复地执行从而确定何时导管已经被合乎期望地放置，例如，举例来说，邻近RA/SVC接合部位。理解的是，在一个实施方案中，系统10包括适合的算法来计算、跟踪、储存和显示各离散导管位置处的阻抗以及当导管在脉管系统中被推进时的阻抗改变。此外，系统10可以包括各种功能来以使用者友好的可视方式描绘和显示所跟踪的数据来在显示器30上进行描绘，包括用于显示数字和/或模拟格式的阻抗数据和/或其他生物物理参数的电路。注意的是，导管进入患者的脉管系统的示意性插入部位包括手臂(头静脉)、脖颈(颈静脉)以及腹股沟(股动脉)。当然，可以使用其他插入部位。
在一个实施方案中，通信端口和软件可以与系统10一起被包括来使得系统所感测和/或采用的生物物理参数(例如，阻抗、电流和电压)能够被输出，来由其他医疗设备(例如，临床生命体征设备、血流动力系统、麻醉系统、电生理学实验室系统、计算机、储存系统、数据分析系统等)使用。
在其他实施方案中，系统的电极阵列可以不同于本文所描述的内容，来用于识别和确认脉管系统中并且邻近心脏的具体解剖学上的位置，包括与导管(包括探针)或其他留置医疗设备一起被包括的双极和/或单极电极。此外，在一个实施方案中，由本文所描述的系统检测的阻抗值可以被用来描绘心脏附近的脉管系统的图，所述数据可以与射线照相获得的患者的解剖结构(anatomy)标记有关。
如上所述的，在一个实施方案中，电极90A、90B通过绳缆78经由传感器50可操作地连接到控制台20。在这种情况下，绳缆78和/或相关联的连接器被配置来穿透通过无菌屏障，从而使得电极90A、90B能够与控制台20可操作地连接，该无菌屏障围绕在患者的导管插入部位附近建立的无菌区域而不破坏该无菌区域。关于这样的穿过无菌区域的实施例和其他细节可以参见美国专利申请公开No.2011/0015533，该美国专利申请公开No.2011/0015533通过上面的引用被并入。
在又一实施方案中，理解的是，多个电极或电极阵列可以与导管一起被包括或者与导管相关联，以致可以在沿导管的远侧部分的长度的不同位置同时进行多个阻抗测量。在又另一实施方案中，并且如上面所提到的，理解的是，基于ECG的导管末端定位可以与本文所描述的基于阻抗的定位技术结合使用。在这样的配置中，基于ECG的定位方法可以被用来将导管远侧末端导引到一般为优选的区域，在这之后基于阻抗的定位可以被用来将导管远侧末端准确地放置在脉管系统中的期望位置。关于这样的基于ECG定位的其他细节可以参见美国专利申请公开No.2011/0015533，该美国专利申请公开No.2011/0015533通过上面的引用被并入。
如所述的，在一个实施方案中，如图3中可见的，将导管72安置在血管80中是必要的，以使电极阵列90的电极90A、90B与血管的内部组织表面92进行物理接触。在一个实施方案中，这一点可以通过使导管的远侧部分在其所设置的血管的血流中偏移来实现。图6示出用于这样的偏移的设备的实施例，包括设置在导管72的内腔72A中的探针110，从而探针的远侧部分向远侧延伸到导管的远侧末端76A。探针110包括转向翼112，转向翼112被可枢转地安装在探针的远侧端，从而能够在图6中的虚线所示的对齐位置和偏移位置之间被选择性地移动。致动丝114被附接到翼112并且延伸通过探针110的长度，从而使得患者外部的临床医生能够选择性地偏移该翼。翼从图6的其对齐位置的偏移导致翼干预(interfere with)流过血管的血流，这又导致探针110和导管72的远侧部分76能够被推动到血管的另一侧，由此使得电极90A、90B能够与血管的内部表面进行物理上的接触。一旦不再需要电极90A、90B的物理接触，则致动丝114可以被移动来使得翼112到对齐状态，由此停止翼与血管血流的干预接合(interfere engagement)。注意的是，翼和探针的特定配置和形状可以不同于本文所示出并描述的内容。此外，探针可以从导管远侧末端76A延伸出比图6中所示的要更少或更多。
图7示出根据另一实施方案的导管转向构件，其中转向翼122被包括在导管72的远侧末端76A并且具有可操作地连接到转向翼122的致动丝124，来使得临床医生能够将翼从对齐位置选择性地折叠到图7中所示的虚线偏移位置。翼122以与图6的翼112类似的方式操作，导致导管72在血流中的偏移，从而电极90A、90B的至少一部分可以接触血管内部表面。
图8示出根据另一实施方案的导管转向构件，其中两个转向翼122被包括在导管远侧端76A，每个可操作地连接到单独的致动丝124，从而导管远侧部分的偏移通过致动所述翼中的一个或两个以使远侧部分在特定方向上偏移来选择性地实现。在一个实施方案中，翼可以被用来将导管保持在血管的中心部分中，从而使得导管能够被引导通过困难的或曲折的脉管解剖结构并且减少血管壁损坏。注意的是，本文所公开的翼的数目、形状、尺寸以及特定设计可以不同于所示出和描述的内容。
图9A和图9B根据另一实施方案示出导管转向构件，其中导管72的远侧部分包括可展开的翼或翅132，来与血管血流进行相互作用，以导致导管的远侧部分76朝向导管被设置于其中的血管80的壁的偏移。反过来，这使得血管80的内部壁与导管电极阵列90的电极之间能够形成接触。如图9B中所示的，在本实施方案中，翅114是三角形或者半锥形的，然而在其他实施方案中，其他的翅形状是可能的。在一个实施方案中，翅可以为选择性地可延伸的/可折叠的。
在一个实施方案中，要理解的是，脉管系统中基于阻抗的引导和测量可以被用来检测血管内异常的区域。例如，采用本文所描述的方法的阻抗测量导管或其他脉管内设备可以被用来检测冠状动脉中的斑块位置，例如内膜中包括泡沫细胞和脂肪沉积的早期动脉粥样硬化损伤。这样的斑块沉积是不稳定的并且容易破裂，这会使内皮下斑块暴露于血流。这又会导致血小板凝块形成以及不稳定型绞痛或急性心肌梗死。这样的区域通过阻抗差测量相对于周围血管组织的检测可以使得预防性治疗(例如，血管成形术、支架植入术)能够开始来缓解由此产生的任何危险。
基于阻抗的引导和测量在一个实施方案中还可以被用来检测静脉和/或动脉中的预狭窄损伤。注意的是，冠状动脉粥样硬化和外周动脉以及中心和外周静脉(包括被包括在用于血液透析的AV进入电路中的静脉)的狭窄是通常利用血管成形术治疗的常见问题。如本文所描述的，这样的区域通过阻抗差测量(“绘图(mapping)”)相对于周围血管组织的检测可以使得预防性治疗能够开始，来在仍处于血管壁的早期发展阶段、明显血管缩窄之前避免危险区域中的问题，例如那些容易再狭窄和/或重新狭窄的问题。在一个实施方案中，实心本体导管或包括内腔的导管被用来承载阻抗电极以检测狭窄和/或预狭窄损伤。示例性配置在图10中被示出，其中包括电极90A、90B的导管72被设置在血管80中，从而电极邻近预狭窄损伤部位140被安置。损伤部位140上和损伤部位140周围的不同阻抗测量值可以向临床医生指示该损伤部位140的存在，该临床医生则可以根据需要处理这样的区域。在另一实施方案中，阻抗电极可以被包括在血管成形囊组件、支架植入组件或者药物洗脱囊组件上，从而在预狭窄区域的检测之后立即实施适合的治疗(例如，血管成形术、支架植入术、药物递送)。注意的是，在一个实施方案中，狭窄和/或预狭窄损伤的检测可以需要使用不同于用于基于阻抗的导管末端放置的RF源频率的RF源频率。
在又另一实施方案中，要理解的是，血管内的阻抗测量值可以被用来确保已经实现到动脉或静脉中的预期的一个的进入。要理解的是，在血管内手术期间静脉而不是预期的动脉(或者反之亦然)的意外导管插入在包括心导管插入、中心静脉导管放置等手术期间会产生不利影响。血管的内部壁的部分的阻抗值的测量在实现进入血管之后可以指示血管是动脉还是静脉，由此使得临床医生能够确认已经进入适当类型的血管。注意的是，动脉的阻抗值一般地落入静脉和心肌组织的阻抗值之间。这样的关系使得静脉和动脉之间的辨识能够实现。因此，动脉(例如，典型地导管插入的那些动脉(股动脉、锁骨下动脉、臂动脉等))在血管内手术期间可以通过其阻抗来识别。静脉可以被类似地识别，由此降低与不恰当的血管穿孔相关的不利事件的可能性。
上述阻抗关系在图11和图12中被描绘，其中在图11中，示出具有厚度t1的相对厚壁的静脉血管80。包括电极(例如电极90B)的导管72被设置在静脉血管80中。如上面所描述的，电极所取得的阻抗测量值可以使得临床医生能够确定导管72是否被设置在静脉或动脉中。图12示出设置在具有厚度t2的动脉血管80中的导管72的对应情形，厚度t2相对于静脉的厚度t1是较薄的。如所述的，所测量的动脉的阻抗将一般地低于静脉的阻抗，但高于心脏相关的组织的阻抗。
图13示出在一个实施方案中，延伸的电极丝150可以被添加到电极90A、90B中的一个或两个，从而使得电极阵列90能够在导管72自身无法邻近血管的表面被设置时与组织表面92进行可操作的接触。延伸的电极丝可以以顺从的方式(compliant manner)被配置，从而使得电极丝能够在导管72推进通过脉管系统期间根据需要变形而仍保持与组织表面92的接触，以致在期望的时候可以取得阻抗测量值。在本实施方案中，四个弯曲的电极丝150被附接到每个电极90A、90B。然而，注意的是，延伸的电极丝的数目、尺寸、形状、延伸程度以及其他配置可以不同于本文所示出并描述的内容。
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 (26)

1.一种用于在患者的脉管系统中引导导管的方法，所述方法包括：
将所述导管引入患者的血管，所述导管限定内腔，流体能够通过所述内腔被输注到所述患者的脉管系统中；
将所述导管朝向脉管系统中的目标部位推进；以及
基于与所述血管的第一组织表面相关的至少一个电气性质的脉管内检测计算至少第一阻抗值，以使得所述导管的远侧端相对于所述目标部位的接近度的确定得以进行。
2.如权利要求1所限定的用于引导导管的方法，其中计算所述至少第一阻抗值是由处理器基于通过与所述导管相关联的至少一个电极对进行的对至少一个电气性质的检测来执行的，所述至少一个电极可操作地连接到所述处理器，所述至少一个电气性质包括跨所述电极对的电压值，所述电极对邻近所述第一组织表面设置。
3.如权利要求2所限定的用于引导导管的方法，其中计算所述至少第一阻抗值还包括：
向邻近所述第一组织表面设置的电极对提供电流；
检测跨所述电极对的电压值；以及
基于所提供的电流和所检测的电压计算所述至少第一阻抗值。
4.如权利要求3所限定的用于引导的方法，还包括：
在提供所述电流之前建立所述电极对与所述组织表面的物理接触。
5.如权利要求4所限定的用于引导的方法，还包括：
在供临床医生观察的显示器上描绘与所计算的至少一个阻抗值相关的数据。
6.如权利要求5所限定的用于引导的方法，还包括：
推进所述导管，从而所述电极对邻近所述血管中的第二组织表面；
将电流提供到所述电极对；
检测跨所述电极对的电压值；以及
基于所提供的电流和所检测的电压计算第二阻抗值。
7.如权利要求6所限定的用于引导的方法，其中所述目标部位邻近所述患者的上腔静脉和心脏的右心房的接合部位，并且其中所述第一阻抗值和所述第二阻抗值之间的阻抗降表示所述导管的远侧端从所述上腔静脉朝向所述接合部位的推进。
8.一种导管引导系统，所述系统包括：
用于设置在患者血管中的导管，所述导管限定至少一个内腔，流体能够通过所述至少一个内腔被输注到脉管系统中；
用于提供电流的RF源；
邻近所述导管的远侧末端被包括的至少一个电极对，所述电流被提供到所述至少一个电极对；
用于当所述电流被提供到所述电极对并且所述电极对被邻近所述血管的组织表面设置时测量跨所述电极对的电压值的装置；
用于根据所提供的电流值和电压值计算阻抗值的处理器；以及
用于描绘与所计算的阻抗值相关的数据以辅助临床医生确定所述导管的远侧末端在脉管系统中的位置的显示器。
9.如权利要求8所限定的导管引导系统，其中用于测量电压值的装置是伏特计，所述伏特计被可操作地连接到所述处理器，并且其中所述系统还包括用于测量所述电流的幅值的安培计，所述安培计被可操作地连接到所述处理器。
10.如权利要求9所限定的导管引导系统，其中所述RF源、所述伏特计、所述处理器以及所述显示器被包括在控制台中。
11.如权利要求8所限定的导管引导系统，还包括用于以磁性方式在脉管系统中跟踪所述导管的磁性跟踪系统以及用于以超声方式对所述血管的至少一部分成像的超声成像系统。
12.如权利要求8所限定的导管引导系统，其中所述电极对被设置在邻近所述导管的远侧末端的所述导管的外表面上。
13.如权利要求8所限定的导管引导系统，其中所述电极对被包括在探针上，所述探针被可移除地接纳在所述导管的至少一个内腔中。
14.如权利要求8所限定的导管引导系统，其中所述导管还包括转向部件来选择性地使所述电极对转向而与所述血管的所述组织表面进行物理接触。
15.如权利要求14所限定的导管引导系统，其中探针被设置在所述导管的至少一个内腔中，并且其中所述转向部件包括可移动的转向翼，所述可移动的转向翼设置在所述探针的远侧部分上、从所述导管的远侧末端向远侧延伸。
16.如权利要求14所限定的导管引导系统，其中所述转向部件包括邻近所述导管的远侧末端设置的单个可移动的转向翼。
17.如权利要求14所限定的导管引导系统，其中所述转向部件包括邻近所述导管的远程末端设置的第一和第二可移动的转向翼，每个转向翼可操作地连接到致动丝来由临床医生对所述转向翼进行选择性的致动，所述转向翼可移动来在所述血管的中心区域内使所述导管的远侧末端居中。
18.如权利要求14所限定的导管引导系统，其中所述转向部件包括限定基本上为三角形的形状的可展开的翼。
19.如权利要求8所限定的导管引导系统，其中所计算的阻抗值进一步使得临床医生能够确定所述导管在静脉和动脉中的一个中的放置。
20.如权利要求8所限定的导管引导系统，其中所计算的阻抗值进一步使得临床医生能够识别所述血管中出现再狭窄或早期斑块形成的区域。
21.一种用于在患者的脉管系统中引导导管的方法，所述导管限定内腔，流体能够通过所述内腔被输注到所述患者的脉管系统中，所述导管包括设置在所述导管的外表面上的至少第一电极对，所述方法包括：
将所述导管引入所述患者的血管；
在脉管系统中朝向目标部位推进所述导管；
将电流提供到所述电极对，其中所述电极对邻近第一组织表面设置；
根据电流和所述第一组织表面处的所述电极对的电压值计算至少第一阻抗值；以及
将所述第一阻抗值传递给使用者来确定所述导管的远侧末端相对于所述目标部位的接近度。
22.如权利要求21所限定的用于引导的方法，还包括：
进一步推进所述导管从而所述电极对邻近第二组织表面被设置；
将电流提供到所述电极对，其中所述电极对邻近所述第二组织表面设置；
根据电流和所述第二组织表面处的所述电极对的电压值计算第二阻抗值；以及
比较所述第一阻抗值与所述第二阻抗值来确定所述导管的远侧末端相对于所述目标部位的接近度。
23.如权利要求22所限定的用于引导的方法，还包括：
储存所述第一和第二阻抗值，用于以后使用。
24.如权利要求22所限定的用于引导的方法，其中当所述第二阻抗值相对于所述第一阻抗值是较小的时，所述临床医生能够判断所述导管的远侧末端正在靠近所述患者的心脏的右心房。
25.如权利要求22所限定的用于引导的方法，其中当提供电流时，所述电极对物理地接触所述第一组织表面和所述第二组织表面。
26.如权利要求22所限定的用于引导的方法，其中所述电极对的至少一个电极包括顺从地接合所述第一组织表面和所述第二组织表面中一个的至少一个延伸的电极丝。
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US20140343398A1 (en) 2014-11-20
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