CN101925379A - 带有mri兼容设计特征的导线 - Google Patents

带有mri兼容设计特征的导线 Download PDF

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CN101925379A
CN101925379A CN2009801029447A CN200980102944A CN101925379A CN 101925379 A CN101925379 A CN 101925379A CN 2009801029447 A CN2009801029447 A CN 2009801029447A CN 200980102944 A CN200980102944 A CN 200980102944A CN 101925379 A CN101925379 A CN 101925379A
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electrode conductor
conductor line
line
lead
inner electrode
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CN101925379B (zh
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阿瑟·J·福斯特
琼·M·鲍勃甘
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Cardiac Pacemakers Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
    • A61N1/086—Magnetic resonance imaging [MRI] compatible leads

Abstract

公开了带有磁屏蔽的可植入医疗导线和在诸如核磁共振成像(MRI)等医疗程序过程中从磁场中屏蔽可植入导线的方法。示例性的植入医疗导线包括：螺旋形状缠绕的内部电极导体线；径向围绕该内部电极导体线设置的螺旋形状缠绕的外部电极导体线；和电隔离该内部和外部电极导体线的至少一个绝缘层。该内部电极导体线可以具有中空的多线配置，包括六条或更多条的同径向缠绕线。该外部电极导体线与内部电极导体线电隔离，并可以具有单线或双线配置。

Description

带有MRI兼容设计特征的导线
技术领域
本发明涉及医疗设备和同时提供诊断与治疗处理。更具体地，本发明涉及带有磁屏蔽的可植入医疗导线和用于在诸如核磁共振成像(MRI)等医疗程序过程中屏蔽此类导线与磁场的方法。
背景技术
核磁共振成像(MRI)是使用核磁共振技术呈现病人体内影像的非侵入式成像方法。典型地，MRI系统使用磁场强度在大约0.2至3特斯拉之间的磁性线圈。在该过程中，身体组织主要在垂直于磁场的平面内暴露给电磁能量的射频脉冲。通过测量在组织内受激发原子核的驰豫特性，可以使用来自这些脉冲的结果电磁能量给身体组织成像。
在成像过程中，可以由在诸如起搏器或心脏除颤器等可植入医疗设备内使用的可植入设备导线拾取由MRI系统生成的电磁辐射。该能量可以通过导线传输给与组织接触的电极，这可能导致在接触点上温度升高。组织加热的程度通常与诸如导线长度、导线传导性或阻抗以及导线电极的表面积等因素有关。暴露给磁场还可能在导线上引入不期望的电压。
发明内容
本发明涉及带有磁屏蔽的可植入医疗导线和在诸如核磁共振成像(MRI)等医疗程序过程中屏蔽可植入导线与磁场的方法。示例性的医疗设备包括脉冲生成器和导线，该导线包括螺旋形状缠绕的内部电极导体线、螺旋形状缠绕的外部电极导体线和一个或多个绝缘层。该内部电极导体线具有包括六条或更多条同径向缠绕线的中空多线配置。外部电极导体线与内部电极导体线绝缘，具有单线或双线配置，具有适合于消散在核磁共振程序过程中由导线接收的电磁能量的较高电感。
附图说明
图1是具有在病人身体内植入的导线的说明性医疗设备的示意图；
图2是图示图1导线的简化等效电路的示意图；
图3图示根据示例实施例的图1的导线内部结构；和
图4是图示图3中沿着直线4-4的导线的截面图。
虽然本发明适合于各种修改和替代形式，已经在附图中通过例子和在下文中详细描述了具体实施例。然而，本发明并不限制于所述的具体实施例。相反地，本发明将覆盖落入在由权利要求书定义的本发明保护范围内的全部修改、等同物和替代方式。
具体实施方式
图1是具有在病人身体内植入的导线的说明性医疗设备12的示意图。在所图示的说明性实施例中，该医疗设备12包括在身体内植入的脉冲生成器。脉冲生成器12耦合至插入至病人心脏16内的导线14。心脏16包括右心房18、右心室20、左心房22和左心室24。脉冲生成器12可以皮下植入在身体内，通常在诸如病人胸部或腹部等位置上，尽管其它植入位置也是可能的。
导线14的近端部分26可以耦合至脉冲生成器12或者与其一体成型。导线14的远端部分28可以植入在心脏16的内部或附近的期望位置上，例如在如图所示的右心室20内。在使用中，在导线14远端部分28上的一个或多个电极30可以通过给予心脏16电流的形式向病人提供治疗。在某些实施例中，例如，可以作为用于治疗心动过缓、心动过速或者其它心率失常的心脏导线14的一部分提供一个或多个电极30。
尽管该说明性实施例仅图示了插入到病人心脏16内的单条导线14，在其它实施例中，也可以使用多条导线从而电激励心脏16的其它区域。在一些实施例中，例如，可以将第二导线(未图示)的远端部分植入在右心房18内。此外或者替代地，可以在心脏16的左侧内部或附近(例如在冠状静脉内)植入另一导线以激励心脏16的左侧。在图1中图示的导线14之外，或者替代地，也可以使用其它类型的导线，例如心外膜导线。
在操作过程中，可以配置导线14以在脉冲生成器12和心脏16之间传送电信号。例如，在脉冲生成器12是起搏器的那些实施例中，可以使用导线14发送用于起搏心脏16的电治疗激励。例如，在心动过缓或心动过速的治疗中，可以使用脉冲生成器12以到心脏16的起搏脉冲的形式发送电激励。在脉冲生成器12是可植入心脏除颤器的其它实施例中，可以使用导线14响应于诸如心脏病发作或心率失常等事件将电击发送给心脏16。在一些实施例中，脉冲生成器12同时包括起搏和除颤性能。
当脉冲生成器12经受来自MRI扫描器或其它外部磁源的磁场时，在身体内产生电磁辐射，其可以由导线14拾取和传送给与身体组织接触的一个或多个导线电极30。该电磁辐射可以导致在该一个或多个电极30和身体组织的接触面上的加热，并可能干扰由脉冲生成器12通过导线14传送的治疗电流。
图2是图示图1的导线14的简化等效电路32的示意图，表示在导线14上自由MRI扫描器生成的射频电磁能量中拾取的射频能量。如图2所示，在电路32内的Vi34代表由导线14自MRI扫描器拾取的等效能量源。在核磁共振成像过程中，导线14的长度功能类似于天线，接收自MRI扫描器发送至身体内部的射频能量。在图2中的电压(Vi)34可以表示例如由导线14自射频能量接收的结果电压。由导线14拾取的射频能量可以因为例如由MRI扫描器生成的旋转射频磁场所导致，这在与传导组织内的旋转磁场矢量垂直的平面内生成电场。这些电场沿着导线14长度的切线分量耦合至导线14。因此，电压(Vi)34等于沿着导线14长度的切线电场的积分(即电场的线积分)。
在电路32内的ZI参数36代表在MRI扫描器的射频频率上由导线14呈现的等效阻抗。阻抗值ZI 36可以代表例如在1.5特斯拉MRI扫描器的64MHz射频频率上或者在3特斯拉MRI扫描器的128MHz射频频率上由导线14呈现的平行电感和线圈逐圈电容导致的电感或等效阻抗。导线14的阻抗ZI是包括实部(即电阻)和虚部(即电抗)的复数量值。
在电路32内的Zb 38可以代表身体组织在导线接触点上的阻抗。Zc 40可以代表沿着导线14的长度该导线14至周围身体组织的电容耦合，这可能提供高频电流(能量)在MRI扫描器的射频频率下泄露到周围组织内的路径。最小化所吸收的能量(用源Vi 34表示)降低了在导线与身体组织的接触点上传送至身体组织的能量。
如从图2可以进一步看出的，导线14具有在MRI扫描器的射频频率下到周围组织的一定量的泄露40。如38进一步指示的，在一个或多个电极30与其周围的心脏16内的身体组织的接触点上也存在阻抗。可通过下述公式关联发送至身体组织的结果电压Vb：
Vb＝Vi Zbe/(Zbe+Zi)，其中Zbe＝Zb并联Zc。
在通常与周围组织接触的导线14尖端上的温度部分地与在38(即在“Zb”)上消散的功率相关，其又与Vb的平方相关。为了最小化因为在38上消散的功率导致的温度升高，因而希望最小化Vi(34)和Zc(40)，同时还最大化导线14的阻抗ZI(36)。在一些实施例中，导线14的阻抗ZI(36)可以在MRI扫描器的射频频率下升高，这有助于降低在接触点38处消散到周围身体组织内的能量。
在一些实施例中，通过将电感添加给导线14和/或通过适当的构造技术，可以提高导线14的阻抗。例如，通过增加一个或多个导体线圈的直径和/或通过降低用于将电能量提供给一个或多个电极30的一个或多个导体线圈的螺距，可以提高导线14的电感。降低线圈螺距可能导致提高在线圈的连续绕圈之间的电容(即线圈逐圈电容)。电感(线圈螺旋形状形成的)和逐圈电容的并行组合构成谐振电路。对于螺旋线圈的导线结构，如果导线的谐振频率在MRI的射频频率之上，则该螺旋线圈用作电感器。对于电感器而言，提高线圈的截面积和/或降低线圈螺距增加电感，从而增加导线14的阻抗。
类似于天线，自导线处拾取的能量涉及其与所关注频率波长相关的谐振长度。例如，对于偶极天线，当天线长度是波长一半或者波长的整数倍时，将天线视为调谐或者在谐振。在谐振长度上，最大化天线的能量拾取。以类似的方式，和在一些实施例中，可以解谐导线14从而防止在导线14内的谐振，从而最小化电压Vi。对于图1图示的说明性实施例，例如，导线14用作具有在长度L＝整数×λ/2的谐振频率的天线。在一些实施例中，可以选择影响波长的导线14的长度和/或导线14的结构参数，从而避免在导线14内的谐振。
在一些实施例中，除了相对于MRI引入射频能量的波长解谐导线14的长度之外，也可以将屏蔽添加给导线14以进一步降低自导线14处拾取的电磁能量。例如，自屏蔽处拾取的能量可以沿着导线14的长度耦合至病人身体，防止该能量耦合至导线尖端。将电阻材料用于屏蔽结构，通过作为电阻损耗消散能量，也可以抑制沿着屏蔽/导线长度通过屏蔽来传输所截取的能量。
图3图示根据示例实施例的图1的导线14的内部结构。在图3的实施例中，导线14包括内部电极导体线42、外部电极导体线44和围绕外部电极导体线44径向设置的绝缘层46。内部导体线42可以具有在现有技术中公知的任意数量的不同配置，包括但是并不限制于线圈配置、电缆配置、直线配置、等。
在图3的说明性实施例中，内部导体线42包括螺旋形多线线圈导体线，后者具有多条线绳48，它们紧密缠绕在一起以形成用于通过导线14发送电激励能量的内部电极。在一种实施例中，例如，内部导体线42包括形成螺线形状导体的六条或更多条线绳48。在其它实施例中，内部导体线42可以包括更多或更少数量的线绳48。在一种实施例中，例如，内部导体线42可以包括十二条同径向缠绕的线绳48。在一些实施例中，形成内部导体线42的每条线绳48可以包括在截面面积上具有大约10％至28％的银含量的银填充MP35N导线。
在一些实施例中，内部导体线42具有中空配置，包括通过线42延伸和适合于接收探针或导线的内腔50，该探针或导线可用于协助将导线14植入身体内部。在某些实施例中，通过围绕直径略大于可插入到空腔50内的探针或导线直径的心轴同径向地缠绕多条线绳可以制造内部导体线42。为了改善导线42的扭矩特性，在制造导线42的过程中可以将线绳48紧密地缠绕在一起，以使在线绳48之间不存在间隙或间隔。
如图3中进一步图示的，和在一些实施例中，将外部导体线44围绕内部导体线42共轴设置，外部导体线44具有沿着导线14长度的全部或一部分延伸的螺旋线圈配置。在一些实施例中，外部导体线44具有由单根绕线构成的单线配置。在其它实施例中，外部导体44具有由多条同径缠绕线绳构成的多线配置。在一个实施例中，例如，外部导体线44具有由两条同径缠绕线绳构成的双线配置。
外部导体线44可以与内部导体线44径向间隔，电隔离外部导体线44与内部导体线42。在一些实施例中，例如，外部导体线44电隔离内部导体线42，以便导线14可以用作多极导线。在某些实施例中，还在内部导体线42和外部导体线44之间使用第二绝缘层52彼此电隔离导体线42、44。在一些实施例中，例如，第二绝缘层52可以包括由硅、聚亚安酯或其它适当聚合材料构成的外壳。
图4是图示沿着图3中的直线4-4的导线14的截面视图。如在图4中进一步图示的，和在一些实施例中，外部导体线44由小直径线构成以降低线44的有效螺距，其又提高线44的电感。在一些实施例中，例如，外部导体线44的线直径D1在大约0.001至0.006英寸之间的范围内，更具体地，大约0.003至0.004英寸。然而，根据所使用导线的类型、导线配置以及其它因素，外部导体线44的线直径D1可以更大或更小。由于外部导体线44的较小直径D1，与具有较大线直径的更常规的导线相比，沿着导线14的长度存在更多数量的线圈绕圈，这提高了导体线44的阻抗。该提高的阻抗有助于降低消散到一个或多个导线电极30之上或附近的周围身体组织内的能量。
也可以提高外部导体线44的整体直径D2以进一步提高导线44的电感。在一些实施例中，例如，外部导体线44的整体直径D2在大约0.051至0.068英寸之间的范围内，更具体地，大约0.053至0.066英寸。然而，根据所使用的导线类型、导线配置以及其它因素，外部导体线44的整体直径可以更大或更小。在一些实施例中，导线14的整体直径在大约3至7Fr之间，更具体地，在大约5至6Fr之间的范围内。
在一些实施例中，外部导体线44由拉伸填充管构成，其具有由低阻金属或金属合金如MP35N组成的外部管状并填充有由导电材料如银等内核。一旦填充和拉伸，则使用现有技术中公知的常规技术将该管卷绕成螺旋形状并附装在导线14上。在一种实施例中，外部导体线44包括在截面面积上大约28％银含量的银填充MP35N导线。在使用中，可以使用构成外部导体线44一部分的外部管状金属或金属合金的较低电阻抵消因为如上文讨论的使用较小直径导线导致的给导线44增加的阻抗。在一些实施例中，还可以选择构成外部导体线44的一种或多种材料从而给予导线44更大的柔韧性。
外部导体线44可以由不同于内部导体线42的一种或多种材料构成，从而给予外部导体线44更大的阻抗以有助于耗散在MRI程序过程中接收的射频电磁能量。在一种实施例中，例如，构成外部导体线44的线绳可以包括具有(在截面面积上)大约28％的银含量的银填充MP35N材料，而构成内部导体线42的线绳可以具有(在截面面积上)低于28％的银含量。
如图4进一步图示的，和在一些实施例中，内部导体线42具有在大约0.001至0.004英寸之间的线直径D3，和更具体地，大约0.002英寸。在某些实施例中，内部导体线42的外直径D4在大约0.020至0.028英寸之间，和更具体地，在大约0.022至0.023英寸之间。然而，内部导体线42的尺寸，包括线直径D3和外部直径D4，均可以改变。
通过提高导线14的电感，以及特别是外部导体线44的电感，配置导线14以消散在核磁共振成像过程中接收的射频电磁能量。消散电磁能量导致降低了在该一个或多个电极30的位置处的身体组织的加热。导线14电感的增加还降低了电磁能量对通过导线14发送的治疗电流的影响，和在一些情况下，可以允许导线14在MRI过程中继续提供治疗。在一些实施例中，例如，导线14电感的增加允许导线14以常规设备频率(例如0.5Hz至500Hz)工作，同时用作在MRI频率上的低效天线。
虽然针对用于对病人心脏16提供起搏的心脏导线描述了该说明性导线14，但是该导线14的结构也可以应用于在存在电磁场的情况下操作的其它医疗设备。例如，导线14的结构，包括内部和外部导体线42、44，可以使用于在利用MRI成像的神经学应用中使用的神经导线。
在不脱离本发明的范围的情况下，可以对所讨论的示例实施例进行各种修改和添加。例如，虽然上述实施例描述了具体特征，但是本发明的范围还包括具有不同特征组合的实施例以及并不包括全部所述特征的实施例。因此，本发明的范围将涵盖落入在权利要求书保护范围及其全部等同范围之内的所有此类替代、修改和变化。

Claims (20)

1.一种医疗设备，包括：
脉冲生成器；
电耦合至该脉冲生成器的导线，该导线包括沿着导线长度的全部或一部分螺旋形状设置的内部电极导体线，该内部电极导体线具有中空的多线配置，包括六条或更多条的同径向缠绕线；
沿着导线长度的全部或一部分围绕内部电极导体线螺旋形状设置并与其间隔开的外部电极导体线，该外部电极导体线具有单条或双条线配置；
径向围绕内部电极导体线设置的至少一个绝缘层；和
其中配置该外部电极导体线以消散在核磁共振成像程序过程中由该导线接收的电磁能量。
2.权利要求1的医疗设备，其中该内部电极导体线包括十二条同径向缠绕线。
3.权利要求1的医疗设备，其中内部电极导体线的每条线具有在大约0.001至0.004英寸之间的线直径。
4.权利要求1的医疗设备，其中内部电极导体线具有在大约0.020至0.028英寸之间的外直径。
5.权利要求1的医疗设备，其中内部电极导体线的每条线包括银填充MP35N材料，在截面面积上具有低于大约28％的银含量。
6.权利要求5的医疗设备，其中外部电极导体线的每条线包括银填充MP35N材料，在截面面积上具有大约28％的银含量。
7.权利要求1的医疗设备，其中外部电极导体线包括单线。
8.权利要求1的医疗设备，其中外部电极导体线包括双线。
9.权利要求1的医疗设备，其中外部电极导体线具有在大约0.001至0.006英寸之间的线直径。
10.权利要求1的医疗设备，其中外部电极导体线具有在大约0.051至0.068英寸之间的外直径。
11.权利要求1的医疗设备，其中至少一个绝缘层包括：
围绕外部电极导体线设置的第一绝缘层；和
在外部电极导体线和内部电极导体线之间介入的第二绝缘层。
12.一种可植入医疗导线，包括：
沿着导线长度的全部或一部分螺旋形状设置的内部电极导体线，该内部电极导体线具有中空的多线配置，包括六条或更多条的同径向缠绕线，该内部电极导体线的每条线由银填充MP35N材料构成；
沿着导线长度的全部或一部分围绕内部电极导体线螺旋形状设置和与其间隔开的外部电极导体线，该外部电极导体线具有单线或双线配置，该外部电极导体线的每条线由具有与内部电极导体线不同的银含量的银填充MP35N材料构成；
径向围绕内部电极导体线设置的至少一个绝缘层；和
其中配置该外部电极导体线以消散在核磁共振成像程序过程中由该导线接收的电磁能量。
13.权利要求12的医疗导线，其中该内部电极导体线包括十二条同径向缠绕线。
14.权利要求12的医疗导线，其中内部电极导体线的每条线具有在大约0.001至0.004英寸之间的线直径。
15.权利要求12的医疗导线，其中内部电极导体线具有在大约0.020至0.028英寸之间的外直径。
16.权利要求12的医疗导线，其中内部电极导体线的每条线包括银填充MP35N材料，在截面面积上具有低于大约28％的银含量。
17.权利要求16的医疗导线，其中外部电极导体线的每条线包括银填充MP35N材料，在截面面积上具有大约28％的银含量。
18.权利要求12的医疗导线，其中外部电极导体线具有在大约0.001至0.006英寸之间的线直径。
19.权利要求12的医疗导线，其中外部电极导体线具有在大约0.051至0.068英寸之间的整体直径。
20.一种可植入医疗导线，包括：
沿着导线长度的全部或一部分螺旋形状设置的内部电极导体线，该内部电极导体线具有中空的多线配置，包括六条或更多条的同径向缠绕线；
沿着导线长度的全部或一部分围绕内部电极导体线螺旋形状设置和与其间隔开的外部电极导体线，该外部电极导体线具有单线或双线配置，该外部电极导体线的每条线具有在大约0.001至0.006英寸之间的线直径；
径向围绕内部电极导体线设置的至少一个绝缘层；和
其中配置该外部电极导体线以消散在核磁共振成像程序过程中由该导线接收的电磁能量。
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