CN106793968A - 使用微电极的组织诊断和治疗 - Google Patents

使用微电极的组织诊断和治疗 Download PDF

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CN106793968A
CN106793968A CN201580055108.3A CN201580055108A CN106793968A CN 106793968 A CN106793968 A CN 106793968A CN 201580055108 A CN201580055108 A CN 201580055108A CN 106793968 A CN106793968 A CN 106793968A
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electrode
microelectrode
sensing
medical devices
electrodes
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利昂·费伊
保罗·赫尔茨
多伦·哈尔列夫
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Boston Scientific Scimed Inc
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    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0538—Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
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    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
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    • A61B5/6846—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
    • 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

Abstract

公开了医疗设备和用于制造和使用医疗设备的方法。一种示例性电生理学医疗设备可以包括包含远端部的导管轴和具有三个或更多个端子的感测组件。感测组件包括一个或多个电流承载电极和一个或多个感测电极。一个或多个电流承载电极和/或一个或多个感测电极包括微电极。微电极被设置在其他电极中的一个上。该医疗设备还可以包括耦接到感测组件的控制器。

Description

使用微电极的组织诊断和治疗
相关申请的交叉引用
本申请要求2014年10月13日递交的临时申请号62/063,296的优先权，通过参考的方式将其整体并入本文。
技术领域
本公开涉及医疗设备以及用于制造医疗设备的方法。更具体地，本公开涉及组织诊断和/或消融。
背景技术
已经开发了各种体内医疗设备以用于医疗用途例如血管内用途。这些设备中的一些包括导线、导管等等。这些设备是由多种不同的制造方法中的任意一种制造的并且可以根据多种方法中的任意一种来使用。在已知的医疗设备和方法中，每种都具有特定的优点和缺点。日益需要提供可替换的医疗设备以及用于制造和使用医疗设备的可替换的方法。
发明内容
本公开提供了用于医疗设备的设计、材料、制造方法和用途替换。一种示例性电生理学医疗设备可以包括包含远端部的导管轴和具有三个或更多个端子的感测组件。感测组件包括一个或多个电流承载电极和一个或多个感测电极。一个或多个电流承载电极、一个或多个感测电极或者二者包括微电极。微电极被设置在其他电极中的一个上。该医疗设备还可以包括耦接到感测组件的控制器。
另外或可替换地，在任意一个以上实例中，感测组件包括四个端子。
另外或可替换地，在任意一个以上实例中，三个或更多个端子中的一个或多个沿导管轴的远端部被设置。
另外或可替换地，在任意一个以上实例中，三个或更多个端子中的一个或多个沿与导管轴分离的设备被设置。
另外或可替换地，在任意一个以上实例中，一个或多个电流承载电极包括至少一个微电极
另外或可替换地，在任意一个以上实例中，一个或多个电流承载电极包括至少两个微电极。
另外或可替换地，在任意一个以上实例中，一个或多个感测电极包括一个微电极。
另外或可替换地，在任意一个以上实例中，一个或多个感测电极包括两个微电极。
另外或可替换地，在任意一个以上实例中，一个或多个电流承载电极包括微电极，以及一个或多个感测电极包括两个微电极
另外或可替换地，在任意一个以上实例中，一个或多个电流承载电极包括两个微电极，以及一个或多个感测电极包括微电极。
另外或可替换地，在任意一个以上实例中，一个或多个电流承载电极包括两个微电极，以及一个或多个感测电极包括两个微电极。
另外或可替换地，在任意一个以上实例中，一个或多个电流承载电极或一个或多个感测电极包括消融电极。
另外或可替换地，在任意一个以上实例中，一个或多个电流承载电极包括消融电极，以及，一个或多个感测电极包括在消融电极上设置的电极。
另外或可替换地，在任意一个以上实例中，一个或多个感测电极包括消融电极，以及一个或多个电流承载电极包括在消融电极上设置的电极。
另外或可替换地，在任意一个以上实例中，一个或多个电流承载电极或一个或多个感测电极包括环形电极。
另外或可替换地，在任意一个以上实例中，一个或多个电流承载电极包括消融电极和环形电极，以及，一个或多个感测电极包括至少一个微电极。
另外或可替换地，在任意一个以上实例中，一个或多个电流承载电极包括至少一个微电极，以及，一个或多个感测电极包括消融电极和环形电极。
另外或可替换地，在任意一个以上实例中，一个或多个电流承载电极包括消融电极和微电极，以及，一个或多个感测电极包括环形电极和微电极。
另外或可替换地，在任意一个以上实例中，一个或多个电流承载电极包括环形电极和微电极，以及，一个或多个感测电极包括消融电极和微电极。
示例性电生理学医疗设备的另一个实例可以包括包含远端部的导管轴。远端部包括多个电极。多个电极包括至少一个电流承载电极、第一感测电极和第二感测电极。进一步，电极中的至少一个是设置在其他电极中的另一个上的微电极。第一感测电极与电流承载电极间隔第一距离。第二感测电极与电流承载电极间隔第二距离，并且第一距离与第二距离不同。
另外或可替换地，在任意一个以上实例中，该医疗设备还可以包括耦接到多个电极的控制器。至少一个电流承载电极以及第一感测电极和第二感测电极设置成四端子感测配置，并且控制器能够计算第一参数，第一参数能够指示医疗设备与组织的接近度。
一种用于诊断和/或治疗心脏的状况的示例性方法可以包括使电生理学导管经过血管前进到与目标地点相邻的位置并且利用导管确定导管到目标地点的接近度。导管包括远端部和设置在远端部上的四端子感测组件。四端子感测组件包括一个或多个电流承载电极和一个或多个感测电极。一个或多个电流承载电极、一个或多个感测电极或者二者包括微电极。该方法还可以包括耦接到的四端子感测组件的控制器。
一些实施例的以上摘要不是意图描述本公开的每个所公开实施例或者每个实现。接下来的附图和详细描述更具体地例示了这些实施例。
虽然公开了多个实施例，但是通过用于显示和描述本发明的说明性实施例的以下详细描述，本发明的其他实施例将对于本领域熟练技术人员变得显而易见。因此，附图和详细描述应被视为说明性和不是限制性的。
附图说明
考虑结合了附图的以下详细描述，可以更完整地理解本公开，其中：
图1是示例性组织诊断和/或消融系统的平面图；
图2示出了包括远端尖头电极、环形电极和微电极的示例性医疗设备；
图3示出了包括远端尖头电极、环形电极和远离远端尖头电极和/或环形电极定位的微电极的示例性医疗设备；
图4示出了包括被设置成四端子感测配置的远端尖头电极、环形电极和微电极的示例性医疗设备；
图5示出了被设置成四端子感测配置的两个示例性医疗设备，该四端子感测配置具有与消融电极和/或环形电极分离定位的一个微电极。
图6示出了包括被设置成三端子感测配置的远端尖头电极、环形电极和微电极的示例性医疗设备；
图7示出了包括电流注入电极和四个电势测量电极的示例性医疗设备；以及
图8a-图8c示出了相对两个不同介质定位的示例性医疗设备。
虽然本公开可以改成各种修改和替换形式，通过附图中的实例显示并且将详细描述其中的细节。然而，应该理解，不意图将本发明限于所述具体实施例。相反，本发明覆盖落入本公开的精神和范围中的全部修改、等效物和替换物。
具体实施方式
对于下文限定的术语，应该应用这些定义，除非在权利要求或者本说明书的其他地方给出了不同的定义。
本文假设所以数值通过术语“大约”来修饰，不管有没有明确指示。术语“大约”通常涉及本领域熟练技术人员会视为与所引用的值等效的数字范围(例如具有相同的功能或结果)。在许多实例中，术语“大约”可以包括进位到最接近的重要数的数字。
通过端点记载的数值范围包括在该范围内的全部数字(例如1到5包括1、1.5、2、2.75、3、3.80、4和5)。
如说明书和所附权利要求中所使用的，单数形式“一”、“一个”和“该”包括复数个指代物，除非其内容明确指示不是这样。如说明书和所附权利要求中所使用的，术语“或”通常用于意味着包括“和/或”，除非其内容明确指示不是这样。
注意到在说明书中指代的“一个实施例”、“一些实施例”、“其他实施例”等等指示所述实施例可以包括一个或多个具体特征、结构和/或特性。然而，该记载无须意味着全部实施例包括该具体特征、结构和/或特性。另外，当结合一个实施例来描述具体特征、结构和/或特性时，应该理解可以结合无论是否明确描述的其他实施例来使用该具体特征、结构和/或特性，除非明确相反地说明。
应该参考附图来阅读下文的详细描述，其中在不同的附图中类似的元件被相同标号。无需按比例描绘的附图描述了说明性的实施例并且不是意图限制本发明的范围。
导致异常心脏功能的心律不齐和/或其他心脏病理可能源于心脏细胞组织。一种可用于治疗心律不齐和/或心脏病理的技术可以包括对导致心律不齐和/或心脏病理的组织基质的消融。基质中的组织可以通过用于在该组织中引起损伤的热、化学或其他方式来电气地瓦解或消融，或者否则可以与正常心脏线路隔离。电生理学疗法涉及使用消融、标测和/或诊断导管来定位导致心律不齐和/或心脏病理的组织，然后使用消融导管(或其他设备)来破坏和/或隔离该组织。
在执行消融程序之前，医生和/或医师可以利用专用的标测和/或诊断导管来精确定位导致和/或引起心律不齐或其他心脏病理的组织。因此，可能希望能够在执行消融程序之前精确地定位目标组织以便有效地减轻和/或消除心律不齐和/或心脏病理。此外，精确地定位组织可以防止或降低(定位在目标组织附近的)健康组织被损坏的可能性。
可以应用多种方法和/或技术来精确地定位可能被执行消融或其他疗法程序的目标组织。一种示例性方法可以包括利用消融、标测和/或诊断导管来确定导管有多靠近目标组织。此外，消融、标测和/或诊断导管可以包括定位在导管的远端部上的一个或多个感测电极。该电极可以感测、测量和/或向控制器提供与心脏组织中的电活动有关的信息。使用从心脏组织感测和/或测量的电信息，控制器可能能够将导管的远端部的空间位置与心脏组织相关联。例如，电极可以测量阻抗、电阻、电势等等，并且确定诊断和/或消融导管的远端部距心脏组织多远。
结合消融、标测和/或诊断导管来使用的电极通常定位在导管的远端部和/或远端。例如，消融导管可以包括远端尖头电极和定位在远端尖头电极附近的一个或多个环形电极。远端尖头电极除了能够作为消融电极提供消融疗法之外，可能能够感测和/或测量电活动。环形电极可以与另一个和/或消融电极相结合，作为感测和/或测量电极。
通常，电极的尺寸和/或间隔可以有助于由标测和/或诊断导管感测和/或测量的电信息的准确性。例如，一些方法和/或技术可能从第一电极发射电流并且使用不同的电极配对测量本地组织的阻抗(或其他电气特征)。然而，从具有大表面面积的电极发射的电流可能不如从具有(比例上)更小的表面面积的电极发射的电流那么集中。更小的电极表面面积可能往往将电流聚集和/或导向到紧靠该发射和/或测量电极的组织。
此外，在一些情况中，由于尖头和/或环形电极的相对大的尺寸，将消融尖头和/或环形电极邻近目标组织精确地定位是具有挑战性的。具体地，以最佳间隔配置来设置较大电极可能是具有挑战性的，因为较大电极的尺寸和形状可能限制电极彼此可以被放置得多靠近。
另外，较大电极可能(与较小电极相比)更容易检测远场电活动。远场电活动的检测可能不利地影响本地(例如目标)电活动的检测。
因此，在一些实例中可能希望利用、设置、合并和/或耦接较小电极(例如微电极)到标测和/或诊断导管的远端部中。例如，本文公开的一些医疗设备和方法可以包括单独使用微电极或结合消融电极、环形电极、导管和/或其他医疗设备使用微电极来感测和测量电活动。进一步地，本文公开的一些医疗设备和方法可以包括利用从微电极采集的电信息来估计组织接近度和/或接触。还公开了其他方法和医疗设备。
图1示出了示例性心脏标测和/或消融系统10。如图1中所示，系统10可以包括细长构件和导管轴12、RF生成器14和控制器16(例如标测处理器、消融处理器和/或其他处理器)。举例而言，轴12可以可操作地耦接到RF生成器14和控制器16中的至少一个或多个(例如一个或两个)。可替换地或另外地，(除了轴12之外的)设备可用于应用消融能量和/或诊断目标区域并且可以可操作地耦接到RF生成器14和控制器16中的至少一个或多个。RF生成器14可能能够传递和/或可以被配置为以受控的方式传递消融能量到轴12以便消融由控制器16识别的目标区域位置。虽然控制器16和RF生成器14可以显示为离散的组件，但是这些组件或组件特征可以合并到单个设备中。系统10可以根据希望包括一个或多个其他特征中的任意一个。
在至少一些实施例中，轴12可以包括把手18，其可以具有致动器20(例如控制手柄或其他致动器)。把手18(例如近端把手)可以例如定位在轴12的近端。举例而言，轴12可以包括柔性主体，其具有可以包括一个或多个电极的远端部。例如，轴12的远端部可以包括多个环形电极22、远端消融尖头电极24和沿远端消融尖头电极24设置或者否则定位的和/或与远端消融尖头电极24电绝缘的多个微电极26中的一个或多个。
轴12可能是可调整的以助于导航患者的脉管系统或者导航其他内腔。举例而言，可以通过致动器20的操作来偏转轴12的远端部13以实现调整轴12。在一些实例中，可以偏转轴12的远端部13以邻近目标组织定位远端消融尖头电极24和/或微电极26，或将轴12的远端部13定位为用于另一个合适的目的。另外或可替换地，轴12的远端部13可以具有预形成的形状，其适用于助于邻近目标组织定位远端消融尖头电极24和/或微电极组件26。举例而言，轴12的远端部13的预形成的形状可以是辐射形状(例如大体圆形或者大体半圆形)和/或可以定向在横向于轴12的总体纵向的平面中。这些仅仅是实例。
在一些实例中，可以在患者上的消融程序中利用系统10。举例而言，轴12可被配置为被引入或经过患者的脉管系统和/或引入或经过任意其他内腔或腔体。在一个实例中，轴12可以经过患者的脉管系统插入以及进入患者心脏的一个或多个腔室(例如目标区域)。当在患者的内腔或心脏中时，轴12可用于使用环形电极22、微电极26和/或远端消融尖头电极24来标测和/或消融心肌组织。在一些实例中，远端消融尖头电极24可以被配置为应用消融能量到患者的心脏的心肌组织。
远端消融尖头电极24可以具有合适的长度并且包括合适的表面面积。在一些实例中，远端消融尖头电极24可以具有一(1)mm到二十(20)mm之间，三(3)mm到十七(17)mm之间，或者六(6)mm到十四(14)mm之间的长度。在一个说明性实例中，远端消融尖头电极24可以具有大约八(8)mm的轴向长度。此外，远端消融尖头电极可以具有五(5)mm2到一百(100)mm2之间、十(10)mm2到八十(80)mm2之间或二十(20)mm2到七十(70)mm2之间的合适的表面积。在一个说明性实例中，远端消融尖头电极24可以具有大约二十九(29)mm2的表面积。远端消融尖头电极24可以形成于或者否则包括铂和/或其他合适的材料。这些仅仅是实例。
如上所述，微电极26可以围绕远端消融尖头电极24周围分布。微电极26可能能够操作或者被配置为操作在单极性或双极性感测模式中。微电极26可能能够感测或可以被配置为感测与靠近其的心肌组织相对应的电学特征(例如阻抗)。
例如，在一些实例中，系统10可能能够利用阻抗测量来感测导管尖头(例如远端消融尖头电极24)与组织之间的接触。通常，可以通过应用已知的电压或电流到给定介质并且测量结果电压或电流来测量给定介质的阻抗。换句话说，可以通过在两个电极之间注入电流并且测量被注入电流通过其的电极之间的结果电压，获得给定介质的阻抗测量。电压电势与应用的电流之间的比率提供了电流传播通过其的介质的阻抗的指示。
例如，图1示出了电流可以注入在远端消融尖头电极24与环形电极22之间。与远端消融尖头电极24和环形电极22相邻的介质(例如组织)的阻抗可以根据上述方法来测量。例如，如果远端消融尖头电极24和环形电极嵌入在心脏组织中，则可以确定心脏组织的阻抗。
在一些实例中，接触系统10可以利用本地介质的不同阻抗测量来确定远端消融尖头电极24是否正在接触组织。例如，心脏组织的阻抗与血液的阻抗不同。因此，通过知道组织与血液的阻抗之间的相对差异，系统10可能能够确定被应用电流经过的介质是例如血液还是心脏组织。
在一些实例中，微电极26可以可操作地耦接到控制器16。此外，从微电极26生成的输出可以发送到系统10的控制器16以用于以本文讨论的一个或多个方式进行处理和/或用于以其他方式进行处理。如上所述，来自微电极配对的电学特征(例如阻抗)和/或输出信号可以至少部分地形成如上所述的接触估计、消融区域估计(例如组织发育能力估计)和/或消融进展估计(例如损害形成/化脓分析)的基础。
此外，系统10可能能够处理或者可能被配置为处理来自微电极26、环形电极22和/或远端消融尖头电极24的电信号。至少部分地基于来自微电极26、环形电极22和/或远端消融尖头电极24的已处理输出，控制器16可以生成输出给显示器(未显示)以被医生或其他用户使用。在生成输出给显示器的实例和/或其他实例中，控制器16可以可操作地耦接到显示器或者否则与显示器通信。举例而言，显示器可以包括与系统10的使用有关的各种静态和/或动态信息。在一个实例中，显示器可以包括目标区域的图像、轴12的图像和/或传递与组织接近度相对应的信息的指示符中的一个或多个，其可以被用户和/或系统10的处理器分析以确定心律不齐基质在心脏中的存在和/或位置，以确定轴12在心脏中的位置和/或以做出与轴12和/或其他细长构件有关的其他确定。
系统10可以包括与控制器16通信的指示符。指示符可能能够提供与从轴12的一个或多个电极接收到的输出信号的特征有关的指示。在一个实例中，可以在显示器上向医生提供与轴12和/或交互的和/或正在标测的心肌组织的特征有关的指示。在一些情况中，指示符可以提供可视的和/或可听的指示以提供与轴12和/或交互的和/或正在标测的心肌组织的特征有关的信息。例如，系统10可以确定测量的阻抗对应于心脏组织的阻抗值，并且因此可以输出彩色指示符(例如绿色)到显示器。彩色指示符可以允许医生更容易地确定是否应用消融疗法到给定心脏位置。这仅仅是个实例。设想系统10可以利用多种指示符。
在以上公开中，系统10准确地测量阻抗值的能力可能依赖于正在应用到给定介质的电流密度的相对分布。例如，从其发射电流的电极的尺寸可能导致经过不瞄准的周围组织的电流扩散。当比较两个电极的电流密度时，其中一个比另一个适度地大，具有较小表面积的电极可以比较大电极更大程度上聚集电流到局部化的组织。因此，当利用适度地更大的电极时，获得心脏组织中的离散的空间点处的准确的电流传递可能是挑战性的。
图2中显示了关于微电极26、远端消融尖头电极24和环形电极22的另外的细节。图2示出微电极26可以包括“内部”电极28。此外，可以在内部电极28周围设置一层绝缘体32。在微电极26沿远端消融尖头电极24设置的实施例中，绝缘体32将内部电极28与远端消融尖头电极24、环形电极22和/或其他内部电极28绝缘。在一些实施例中，绝缘体32可以围绕内部电极28并且将内部电极28与消融尖头电极24绝缘。
如图2中所示，微电极26可以定位为使得在相邻的微电极26之间存在最小的空间。此外，(例如比远端消融尖头电极24)更小尺寸的微电极26可以允许微电极定位成多个配置。例如，微电极26可以如图2中所示沿圆周对齐。此外，微电极26可以以各种不同配置被偏移。例如，微电极26可以沿轴12的纵轴纵向定位，或者可以定位在远端消融尖头电极24的顶点上。
设想微电极26可以具有在0.20mm2到1mm2之间、0.30mm2到0.80mm2之间或者0.40mm2到0.70mm2之间的合适的暴露表面积。在一个实施例中，微电极26可以具有0.50mm2的合适的暴露表面积。微电极26与远端消融尖头电极24的合适的暴露表面积的比率的比较显示远端消融尖头电极24的合适的暴露表面积可以是微电极26的的合适的表面积的至少十(10)倍、十五(15)倍或者二十(20)倍大。这些仅仅是实例。远端尖头电极24的合适的暴露表面积与微电极26的合适的暴露表面积的比率可以小于或大于二十(20)。例如，远端尖头电极24的合适的暴露表面积与微电极26的合适的暴露表面积的比率可以是30、50或100。此外，远端尖头电极24的合适的暴露表面积与微电极26的合适的暴露表面积的比率可以小于一百七十五(175)。
可替换地，微电极26可以与远端消融尖头电极24、环形电极22结合地或者单独地使用。另外，因为微电极26可以适度地小于远端消融尖头电极24和/或环形电极22，所以微电极26可以关于远端消融尖头电极24和/或环形电极22以多个不同的空间配置被定位。例如，如图2中所示，微电极26可以定位在远端消融尖头电极24“上”。如本文所讨论的，微电极26可以被描述为在给定结构“上”、“沿”给定结构和/或否则嵌入和/或装入给定结构。这不是意图限制。相反，微电极26可以被定位和/或否则位于沿远端尖头的任意合适位置/地方和/或沿导管和/或其他远程结构的其他位置。定位/设置电极可以包括嵌入、部分嵌入、装入、部分装入、隔离、附接、依附、固定、结合到外表面、嵌入壁中等等。
虽然本文大部分讨论涉及其中微电极26被定位在远端消融尖头电极24“上”的实施例，但是进一步设想了一个或多个微电极可以沿导管轴定位在远离远端消融尖头电极24的位置并且继续与在微电极被定位在远端消融尖头电极24“上”的那些实施例中一样实质上等效地起作用。
例如，图3显示了微电极26设置在轴12上远离远端消融尖头电极24。此外，如上所述，设置为远离远端消融尖头电极24的微电极26可以被定位在导管轴12或者消融系统10的任意其他部分“上”。另外，微电极26可以在其他电极(例如环形电极等等)“上”。如上所述，微电极26可以实质上小于远端消融尖头电极24。如图3中所示，微电极26可以实质上小于远端消融尖头电极24。
此外，微电极26的尺寸可以允许微电极26直接设置为邻近可以执行消融、诊断和/或疗法程序的组织。例如，如上文所讨论的，为了经过阻抗测量来确定组织接触，将被测量电压比率(并且因此电阻)的电流必须传递经过这样一种介质(例如组织)即对该介质寻求目标阻抗值。如果电流扩散了和/或部分传递经过非目标介质(例如血液)，则观察阻抗值可能不能准确地表示导管是否与希望的介质(例如组织)接触。
微电极26由于它们相对小的尺寸，可以精确地放置在空间中的离散点处。此外，可能希望在定位在空间中的离散点处的微电极26之间注入电流。可以理解源自微电极26的测量(例如阻抗)可以反映邻近空间中的离散点的介质。例如，通过紧靠定位的微电极26来定位和驱动电流可以提供更大的信心使得源自那里的阻抗测量是准确的。
此外，可能希望靠近远端消融尖头电极24和/或环形电极22定位微电极26。例如，在远端消融尖头24上直接设置紧靠定位的微电极26可以提供信心使得远端消融尖头24事实上与由特定阻抗测量所反映的给定介质接触。
如上所述，(相对于更大的远端消融尖头电极24和/或环形电极22)经过微电极26注入电流可以通过聚集精确地经过局部化的介质的电流路径，提供改善的测量。通过经过较小表面积的微电极26注入电流，可以相对于较大表面积电极降低经过周围组织的电流的扩散。
另外，或可替换地，可以通过使用四端子感测配置，实现阻抗的测量的改善。通常，四端子感测配置驱动电流经过电极配对(类似于如上所述)，并且测量不同的电极配对两端的电压。为了易于理解前文的讨论，后文将其之间以四端子感测配置注入电流的电极配对称为“电流承载”电极配对。将其两端的电压被测量的电极配对称为“感测”电极配对。
四端子感测配置的一个优点在于测量的阻抗可能对电极的阻抗不敏感。在二端子感测配置中，测量的阻抗包括周围介质和两个电极。相反，四端子感测配置测量这样一种电极两端的电压即经过该电极的电流是可忽略的。结果，测量的阻抗是周围介质的阻抗并且大体上独立于电极及其与周围介质的界面的阻抗。
例如，图4示出使用远端消融尖头电极124、环形电极122和两个微电极126的四端子感测配置。另外，图4显示了引线132a-132d。引线132a-132d可以将任意给定电极连接到控制器16、RF生成器14或控制器16和RF生成器14。引线132a-132d还可以以各种配置将单独的电极彼此连接。
参考图4，远端消融尖头电极124和环形电极122可以定义电流承载电极配对。此外，微电极126的配对可以定义感测电极配对。因此，可以在远端消融尖头电极124与环形电极122之间注入电流，并且可以测量微电极126两端的电压。可以理解在该实例中，阻抗测量可能是邻近感测电极配对的介质的阻抗。例如，如果系统10的远端部13嵌入在组织中，则微电极126可以测量邻近微电极126的组织的阻抗。应该理解，使用具有微电极126的四端子系统的一个优点在于可以在离散点处获得阻抗(或其他电学特征)的精确测量。
另外或可替换地，各种组合、设置和/或配置可以在四端子感测配置中包括各种电极(例如远端消融尖头电极、环形电极、微电极、远程参考电极等等)。在一些组合(例如图3或图4中所示的组合)中，电极可以被设置在导管轴12/112的远端部13/113上。在其他组合中，四端子感测配置中的一个或多个电极可以不设置在导管轴12/112和/或远端部13/113上。相反，一些电极可以定位在导管轴12/112和/或远端部13/113外和远处。
例如，图5示出了定位在导管轴112和远端部113远处的电极134。在该实例中，电极134定位在导管轴136上，导管轴136与导管轴112不同或者否则分离。即使图5显示了电极134设置在导管轴136上，也设想电极134可以定位或设置在远离导管轴112的任意结构上。例如，电极134可以设置在患者身体的表面上或者设置在消融系统10的另一部分上。这些仅仅是实例，设想了其他组合和/或远程结构。
与上文关于图2-图4的讨论类似，远离导管轴112和/或设置在导管轴112远处的四端子感测配置中的一个或多个电极可以定位中它们所设置在的结构上。此外，如上所述，任意给定结构可以定位在另一个电极上，该另一个电极独立于其所设置于的电极(例如微电极126设置在远端消融尖头电极124并且与远端消融尖头电极124绝缘)。
另外或可替换地，可以仅使用三个电极来实现和/或配置四端子感测配置。在一些实例中，单个电极(例如远端消融尖头电极、环形电极、微电极、远程电极等等)可以作为电流承载和感测电极来操作。在该情况中，测量阻抗可以包括用于两个目的(例如电流承载和感测)的电极的阻抗以及电极与周围介质的界面的阻抗。如果电极的阻抗低或者预计不会显著变化，则这些配置可以近似四端子配置。包括其中一个电极(及其界面)的阻抗在一些情况中可能是希望的，尤其如果该阻抗随着组织接触而显著变化。
图6示出了三端子感测配置。在图6中，远端消融尖头电极124、微电极126或环形电极122中的任意一个可以作为电流承载和感测电极来操作。此外，关于图2-图5讨论的实施方式和/或配置(例如四端子感测配置)中的任意一个可以实现成三端子配置。
在四端子感测配置的另一个实例中，电流承载电极配对可以包括一个或多个微电极126，而感测电极配对可以包括远端消融尖头电极124和/或环形电极122。
在四端子感测配置的另一个实例中，电流承载电极配对可以包括远端尖头消融电极124和微电极126，而感测电极配对可以包括一个或多个微电极126。
在四端子感测配置的另一个实例中，电流承载电极配对可以包括一个或多个微电极126，而感测电极配对可以包括远端尖头消融电极124和一个或多个微电极126。
在四端子感测配置的另一个实例中，电流承载电极配对可以包括一个或多个微电极126，而感测电极配对可以包括环形电极122和一个或多个微电极126。
在四端子感测配置的另一个实例中，电流承载电极配对可以包括环形电极122和一个或多个微电极126，而感测电极配对可以包括一个或多个微电极126。
在四端子感测配置的另一个实例中，四端子感测配置中的全部电极可以是微电极126。
在四端子感测配置的另一个实例中，电流承载电极配对可以包括一个微电极126和远端尖头消融电极124，而感测电极配对可以包括一个或多个微电极126和环形电极122。
在四端子感测配置的另一个实例中，感测电极配对可以包括一个微电极126和远端尖头消融电极124，而电流承载电极配对可以包括一个或多个微电极126和环形电极122。
在四端子感测配置的另一个实例中，电流承载电极配对可以包括一个微电极126，而感测电极配对可以包括远端尖头消融电极124。
在四端子感测配置的另一个实例中，感测电极配对可以包括一个微电极126，而电流承载电极配对可以包括远端尖头消融电极124。
设想控制器16可以包括这样一种算法即该算法以希望的方式控制各种电极以估计接触。这可以包括以本文公开的方式对电极加电。这还可以包括多个感测配置，感测配置在时间或频率或时间和频率上复用。
虽然上文的讨论指示微电极可以用于组织接触感测，但是这不是意图用于限制。相反，微电极可用于包括消融、标测、感测等等的各种功能。
如上所述，可以显示从上述四端子感测配置中的任意一个获得的阻抗、电阻、电压和/或其他输出，以由外科医生或医生用于诊断。例如，四端子感测配置可以测量和/或感测组织的阻抗，并且输出对应的指示符(如上所述)到显示器。显示器可以连接到控制器16、RF生成器14和/或系统10的任意其他组件。
除了以上公开的方法之外，另外或可替换地，用于估计组织接触的另一种方法可以包括确定模型的参数，以及随着导管12的远端部13在不同介质之间(例如在血液和组织之间)移动，观察参数的改变。
例如，调整因子可以是用于该目的的模型中的参数。该模型可以与一个或多个感测电极和参考电极之间的一个或多个电势差有关。参考电极可以是远离电势测量电极放置的电极。例如，参考电极可以放置在患者的背上。
感测电极可以设置在导管的远端部13的尖头和/或末端上。在一些实例中，感测电极可以包括如本文所述的微电极。
另外或可替换地，该模型还可以与电流承载电极与一个或多个感测电极之间的空间的距离有关。电流承载电极可以采取各种形式。例如，电流承载电极可以是如图1中所示的远端消融尖头电极24。另外或可替换地，电流承载电极可以包括如上面参考图1和图2所述的微电极和/或环形电极。
在一些配置中，感测电极与参考电极之间的电势测量可以被建模为与电流承载电极和感测电极之间的距离成反比。例如，该关系可以被建模为：
在该实例中，参数K可用于估计组织接触。以上方程式仅仅是个实例。设想了其他模型和参数。
如上所述，该模型可能与一个或多个感测电极之间的电势差以及电流承载电极和感测电极之间的距离二者有关。例如，图4示出了示例性远端部213，其包括电流承载电极224和四个感测电极226、234、236和222。图4还显示了引线232a-232e。可以设想电极226、234和236可以包括微电极，而电流承载电极224可以包括远端消融尖头电极。电极226、234、236可以设置在远端尖头消融电极224上。此外，四个感测电极222可以靠近电极224、226、234和236设置。参考图4，电势测量电极222可以是环形电极。图4仅仅是个实例。可以利用多种电极类型的组合和配置作为感测和/或电流承载电极。
在一些实例中，可以由以下方程式表示以上电极和电势值之间的关系。
可以理解变量表示四个感测电极与参考电极之间的测量电势差。另外，可以由系统10确定电势差。此外，可以理解||rCCE1-rSE1||、||rCCE1-rSE2||、||rCCE1-rSE3||和||rCCE1-rSE4||表示电流承载电极分别与四个感测电极之间的(空间)距离的绝对值。进一步理解可以确定这些距离，因为每个感测电极相对应电流承载电极的位置(和距离)是已知的。
可以使用多个用于优化或线性回归的公知技术来估计以上线性方程组中的参数K和C。例如，可以使用最小二乘法来估计K和C。设想了其他方法。
调整因子可以与给定介质的传导性成反比。换句话说，调整因子K可能对于具有不同传导性的两个介质是不同。例如，血液的传导性大于心脏组织的传导性，并且因此，血液的调整因子K将低于心肌组织的传导性。
知道电势差和绝对距离值就可能求解针对调整因子K的以上(线性方程组)。要注意，为了求解所公开的线性方程组，感测电极必须定位在远离电流注入电极的不同距离处。例如，如果距离全部相同，则方程右手边的矩阵将是齐次并且导致无限个等效的解。参考图4，可以看出感测电极226、234、236和222定位在距电流注入电极224的不同距离处。
图4示出了感测电极226、234、236和222沿导管轴12纵向定位。然而设想感测电极226、234、236和222可以定位成除了沿纵轴之外的配置并且仍然维持感测电极与电流承载电极之间的可变距离。另外，在一些实例中可能能够将感测电极的数量降低到两个或三个并且求解针对调整因子K的对应的线性方程组。在其他实例中，可能期望增加感测电极的数量；仍然可以使用公知的技术例如最小二乘法来估计参数K。
从以上讨论可以理解，可能能够利用已知的变量求解针对调整因子K的所公开的线性方程。因此，随着导管12的远端部13在不同介质(例如血液、组织)之间移动，系统10可以确定并且比较不同的调整因子。
图5a-图5c示出了定位在各种介质中的远端部213。例如，图5a显示了完全被血液围绕的远端部213。图5b显示了定位在血液/组织界面处的远端部213。图5c显示了部分地嵌入组织中的远端部213。如所述，对于每个不同的介质，对应于图5a-图5c的生成的调整因子K可以不同。调整因子的差异可以用作远端部213到组织的接近度的诊断指示符。
以下文献通过引用方式合并到本文中：美国专利申请公布号US2008/0243214、美国专利申请公布号US2014/0058375、美国专利申请公布号US2013/0190747、美国专利申请公布号US2013/0060245和美国专利申请公布号US2009/0171345。
在不脱离本发明的范围的前提下，可以对所讨论的示例性实施例做出各种修改和添加。例如，虽然上述实施例涉及具体的特征，但是本发明的范围还包括具有特征的不同组合的实施例以及不包括全部所述特征的实施例。因此，本发明的范围意图包括落入所附权利要求及其等效物的范围中的全部该替换、修改和变形。

Claims (15)

1.一种电生理学医疗设备，包括：
包括远端部的导管轴；
具有三个或更多个端子的感测组件；
其中，所述感测组件包括一个或多个电流承载电极和一个或多个感测电极；
其中，所述一个或多个电流承载电极、所述一个或多个感测电极或者二者包括微电极；
其中，所述微电极被设置在其他电极中的一个上；以及
耦接到所述感测组件的控制器。
2.根据权利要求1所述的医疗设备，其中，所述感测组件包括四个端子。
3.根据权利要求1-2中的任意一个所述的医疗设备，其中，所述三个或更多个端子中的一个或多个沿所述导管轴的所述远端部被设置。
4.根据权利要求1-3中的任意一个所述的医疗设备，其中，所述三个或更多个端子中的一个或多个沿与所述导管轴分离的设备被设置。
5.根据权利要求1-4中的任意一个所述的医疗设备，其中，所述一个或多个电流承载电极包括至少一个微电极。
6.根据权利要求1-5中的任意一个所述的医疗设备，其中，所述一个或多个感测电极包括至少一个微电极。
7.根据权利要求1-6中的任意一个所述的医疗设备，其中，所述一个或多个电流承载电极包括微电极，以及所述一个或多个感测电极包括两个微电极。
8.根据权利要求1-7中的任意一个所述的医疗设备，其中，所述一个或多个电流承载电极包括两个微电极，以及所述一个或多个感测电极包括微电极。
9.根据权利要求1-8中的任意一个所述的医疗设备，其中，所述一个或多个电流承载电极包括两个微电极，以及所述一个或多个感测电极包括两个微电极。
10.根据权利要求1-9中的任意一个所述的医疗设备，其中，所述一个或多个电流承载电极或一个或多个感测电极包括消融电极。
11.根据权利要求1-10中的任意一个所述的医疗设备，其中，所述一个或多个电流承载电极包括消融电极，以及其中，所述一个或多个感测电极包括在所述消融电极上设置的电极。
12.根据权利要求1-11中的任意一个所述的医疗设备，其中，所述一个或多个感测电极包括消融电极，以及所述一个或多个电流承载电极包括在所述消融电极上设置的电极。
13.根据权利要求1-12中的任意一个所述的医疗设备，其中，所述一个或多个电流承载电极或所述一个或多个感测电极包括环形电极。
14.根据权利要求1-13中的任意一个所述的医疗设备，其中，所述一个或多个电流承载电极包括消融电极和环形电极，以及其中，所述一个或多个感测电极包括至少一个微电极。
15.根据权利要求1-14中的任意一个所述的医疗设备，其中，所述一个或多个电流承载电极包括至少一个微电极，以及其中，所述一个或多个感测电极包括消融电极和环形电极。
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