CN101842130A - 具有可变线圈导体间距的可植入导线 - Google Patents
具有可变线圈导体间距的可植入导线 Download PDFInfo
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Abstract
描述了用于在诸如核磁共振成像(MRI)等医疗程序中屏蔽可植入导线和磁场的系统和方法。在各种实施例中,导线包括螺旋形状的内部导体,其至少部分地由一个或多个外部屏蔽导体径向围绕。内部导体的间距可以沿着导线长度改变(例如连续地或者在某些点上),形成沿着导线长度的多个高阻抗点,这导致在核磁共振成像设备的询问频率(例如64MHz、128MHz等)上电磁能量的发散,在一些情况下外部导体同样如此。在一些实施例中,内部导体间距的变化符合正弦函数、修正方波函数或某种其它重复模式。
Description
相关申请的交叉引用
本申请要求于2007年12月6日提交的序列号为60/992,897的美国临时申请的优先权,在此为了全部目的将其全文引用作为参考。
技术领域
本发明的各种实施例一般地涉及医疗设备和诊断与治疗处理的同时提供。更具体地,本发明的实施例涉及在诸如核磁共振成像(MRI)等医疗程序中屏蔽可植入导线与磁场的医疗设备和方法。
背景技术
核磁共振成像(MRI)是使用核磁共振技术显示病人体内图像的非侵入式成像方法。通常,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。在该程序中,身体组织在与磁场垂直的平面内短暂暴露给电磁能量的射频脉冲。通过测量组织内受激发原子核的驰豫属性,这些脉冲的结果电磁能量可以用于给身体组织成像。
在成像过程中,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可能拾取由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升高的温度。组织加热的程度通常涉及诸如导线长度、导线导电性或阻抗和导线电极表面积等因素。暴露给磁场也可能在导线内感应出不希望的电压。
发明内容
描述用于在诸如核磁共振成像(MRI)等医疗程序中屏蔽可植入导线和磁场的系统和方法。一些实施例一般地涉及医疗设备,包括具有远端部分、近端部分和长度的导线。在一些情况下,近端部分可以耦合至脉冲发生器(例如起搏器、心脏除颤器和/或诸如传感器等监视设备、等),远端部分可以包括电极,并可以植入在病人心脏内。在该配置中,例如,配置导线通过内部导体在心脏和脉冲发生器之间传送电信号。
在各种实施例中,导线包括螺旋形状的内部导体。在一些实施例中,内部导体可以至少部分地由一个或多个外部屏蔽导体径向围绕。内部导体间距可以沿着导线长度不断改变,构成沿着导线长度的多个高阻抗点,禁止所吸收的电磁能量在核磁共振成像设备的询问频率上(例如64MHz、128MHz等)沿着导线长度传播。例如,在一种或多种实施例中,内部导体间距上的变化符合正弦函数、修正方波函数、三角函数、锯齿函数、二次函数或某种其它重复模式。在一些实施例中,一个或多个外部屏蔽导体可以具有沿着导线长度不断改变的间距(例如通过正弦函数、修正方波函数或某种其它重复模式),或者可替代地具有沿着导线长度在一个或多个点上改变的间距。
在各种实施例中,该导线可以包括临近导线近端部分和远端部分的低阻抗绝缘层。在MRI程序中,低阻抗绝缘层可以使由MRI设备生成的电磁能量沿着与导线长度相邻的身体组织消散,降低电磁能量到电极的能量传输。
附图说明
图1是具有在病人身体内部植入的导线的说明性医疗设备的示意图;
图2是图示图1导线的简化等同电路的示意图;
图3是图示根据说明性实施例的非线圈导线的远端部分的纵向截面图;
图4是图3的导线的横向截面图;
图5图示具有螺旋结构的图3-4的导线;
图6是图示图5导线的等同电路的示意图;
图7图示在MRI环境中导线的阻抗幅值与射频频率的关系;
图8A图示具有可变线圈导体间距的导线;
图8B图示其中沿着导线长度形成高阻抗频率相关点的一种说明性实施例;
图9图示在两个不同的MRI频率上可变线圈导体间距的阻抗和导线长度的关系的两幅图;
图10图示根据说明性实施例的可变间距导线;
图11图示符合正弦函数的导线间距;和
图12图示符合修正方波函数的导线间距。
虽然本发明可以进行各种修改和替代形式,但是在附图中通过例子图示和在下文中详细描述了具体实施例。然而,并不要将本发明限制于所描述的具体实施例。相反地,本发明将覆盖落入由权利要求书定义的本发明保护范围内的全部修改、等同和替代方式。
具体实施方式
图1是安装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,医疗设备12包括在身体内植入的脉冲发生器。该医疗设备可以耦合至在病人心脏16内配置的导线14。心脏16包括右心房18、右心室20、左心房22和左心室24。可以将脉冲发生器12皮下植入在身体内,尽管其它植入位置也是可行的,通常在诸如病人的胸部或腹部等位置内。
导线14的近端部分26可以耦合至或者与脉冲发生器12一体成型。导线14的远端部分28也可以植入在心脏16的期望位置内,例如如图所示的右心室20内。尽管该说明性实施例仅图示了插入病人心脏16的单根导线14,但是应当理解也可以使用多根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,可以将另一根导线植入在心脏16的左侧(例如在冠状静脉内)以激励心脏16的左侧。除了图1所示的导线14之外或者替代地,也可以使用诸如心外膜导线等其它类型的导线。
在操作过程中,可以配置导线14在心脏16和脉冲发生器12之间传输电信号。例如,在其中脉冲发生器12是起搏器的那些实施例中,可以使用导线14发送用于使心脏16起搏的电治疗激励。在其中脉冲发生器12是可植入心脏除颤器的那些实施例中,可以使用导线14响应于诸如心脏病发作等事件将电击发送给心脏16。在一些实施例中,脉冲发生器12同时包括起搏和除颤能力。
图2是图示代表因为由MRI扫描器生成的电磁能量在导线14上拾取的射频能量的导线14的简化等同电路30的示意图。在成像过程中,导线14的长度L的功能类似于天线,接收自MRI扫描器发送至身体的射频电磁能量。图2中的电压源34代表由导线14自MRI扫描器所生成的射频电磁能量接收(或拾取)的结果电压。导线14所拾取的射频能量可能例如由在核磁共振成像过程中产生的磁场或者由来自病人身体内部或外部的另一设备位置的射频干扰而产生。
等同电路30内的ZI参数32代表导线14在MRI扫描器内在射频频率上呈现的等同阻抗。阻抗值ZI 32可以代表例如导线14在1.5T MRI扫描器的64MHz的射频频率上或者3.0T MRI扫描器的128MHz上呈现的并联电感和电容分量。MRI扫描器的磁场强度通常在0.2-3特斯拉的范围内。因此,射频频率范围将在8.53至128MHz之间。然而,存在工作在其它磁场强度上的其它MRI扫描器,例如但是并不限制于5、7、9或甚至12特斯拉。MRI频率将等于每特斯拉大约42.58MHz。
Zb 38可以代表在导线接触点上的组织阻抗。Zc 36则可以代表导线与沿着导线长度的周围组织的电容耦合,所述长度是高频电流(能量)在MRI扫描器的射频频率上泄露到周围组织内的路径。最小化(所吸收的)能量(用源Vi34代表)降低了在导线与组织的接触点上将传输至组织的能量。
图2中的电路图示和下文描述的相关公式用于说明在MRI环境内导线加热的概念。在电压(电流)波长接近电路大小的频率上,简单的集总求和系统(类似于图2所示的电路)不能准确地模拟导线在MRI环境中的行为。因此,在集总系统并不准确地模拟行为的环境中,为了电路的正确数学描述,应当与麦克斯韦公式一起使用分布式系统。分布式模型是其中在电路几何结构中分布电路组件(例如电阻、电感、电容等)的系统模型。在分布式电路中,在节点(在该情况下导线)上的电压不恒定,并用波形表示。在一些情况下,通过级联该电路小部分的集总单元等同组件,可以建立近似的分布式模型。
如在图2中可以进一步看出的,导线14具有在射频频率上到周围组织内的某一量值的泄露36。如用38进一步表示的,还存在在导线电极和周围身体组织接触点(例如在心脏16内)上的阻抗。用下列公式表述发送给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尖端上的温度与在38(即在“Zb”)上发散的能量相关,其又与Vb平方相关。为了最小化在38上发散的能量导致的温度升高,因而希望最小化Vi(34)和Zc(38),同时最大化ZI(32)。在一些实施例中,可以在MRI扫描器的射频频率上提高导线14的阻抗ZI(32),这有助于降低在38上发散至周围身体组织内的能量。
在一些实施例中,通过给导线增加阻抗和/或通过适当的构造技术,可以提高导线14的阻抗。例如,尽管其它结构是可行的,通过增加导体线圈的直径,可以增加导线14的阻抗。对于螺旋导线结构,如果导线的共振频率高于MRI的射频频率,则螺旋线圈呈现的阻抗用作电感。对于电感,增加线圈区域的横截面将提高电感,进而提高导线14的阻抗。
在某些实施例中,可以解谐导线14从而防止导线14内的共振。对于图1所示的说明性实施例,例如,导线14用作在长度L=整数×λ/2上具有共振频率的天线。在一些实施例中,可以选择导线14的长度,从而避免在导线14内的共振。在各种实施例中,导线14的长度可以在40厘米和100厘米之间。
然而,可以设计导线使其不均匀。在导线构造上的变化可能导致该导线沿着长度的特征阻抗的改变。例如,在一些实施例中,变化可能是在导线结构内使用的线圈间距。根据一些实施例的具有可变间距线圈设计的一个优点在于可变间距线圈提供了在相对于导线拉伸和压缩沿着导线长度提供高阻抗点中的鲁棒性。例如通过制造容限、处理、使用(例如拉动、弯曲、等)以及其它因素可能导致导线的拉伸和压缩。
根据传输线路理论,在特征阻抗内的失配可能导致电磁波的反射。(来自失配阻抗点的)入射和反射波矢量地增加。因此,如果重复导线构造模式,则一些实施例将模式重复距离调整得低于四分之一波长。在四分之一波长分段上,入射和反射波相位相差180度,因此相互抵消,降低了电磁波的幅度。根据各种实施例,四分之一波长可以在10厘米到25厘米的范围内。
在一些实施例中,可以将屏蔽层添加给导线14以降低自导线14拾取的电磁能量。例如,可以将自屏蔽层拾取的能量耦合至沿着导线14的长度L的病人身体,防止其耦合至导线尖端。
图3是更详细地图示图1的非线圈导线14远端部分28的示意图。图3可以代表例如在如将要进一步讨论的弯曲步骤以形成导线14的螺旋形状之前的导线14的纵向截面图。在一些实施例中,如图3所示,导线14包括具有近端(未图示)和远端的内部导体40。可以配置导体的远端以接触周围组织(例如通过电极44)以将治疗能量提供给诸如病人心脏的期望治疗位置。
在一些实施例中,如结合图4中导线的横向截面图进一步图示的,导线14还包括沿着导线14的全部或部分长度延伸的外部屏蔽层42,配置其以至少部分地径向围绕内部导体40以防止MRI扫描器生成的射频电磁波干扰通过导线14发送的电信号。尽管在图3-4的实施例中仅图示单个外部屏蔽导体42,在其它实施例中也可以提供多个外部屏蔽层。类似地,其它实施例包括具有一个或多个外部屏蔽导体42的多根导线。
导线14还包括围绕外部屏蔽导体42和内部导体40设置的多个绝缘材料层。第一绝缘材料层46例如可以使内部导体40与外部屏蔽导体42绝缘。第二绝缘材料层48又可以使外部屏蔽导体42与围绕导线14的身体组织绝缘。一些实施例使用在植入中可以使用的具有最高电介质材料的超薄绝缘体。一些实施例可以使用由具有五至十倍于内部导体的电介质常数的相对电介质常数的材料制成的低阻抗绝缘体。
与沿着导线横截面的低阻抗相比,绝缘体本身通常呈现沿着导线长度的高阻抗。例如通过来自卷绕导线线路的电感,可以实现该高阻抗。图5图示具有沿着其长度的螺旋结构的图3-4的说明性非线圈导线14。如果如图5所示的导线14的绕圈和因而外部屏蔽导体42的绕圈接触相邻绕圈,则产生短路和消除感应效应。在一些实施例中,第二绝缘层48可以防止当将图3-4的非线圈导线14置于图5所示的螺旋结构中时线圈屏蔽层的绕圈彼此接触。在一些实施例中,用于导线给定直径的最大间距可以生成具有期望的可接受机械特征的线圈。
在一些实施例中设置绝缘体48的另一原因在于控制导线的“绕圈电容”。如果诸如血液等流体浸入导线内部,则可能导致线圈绕组之间电容的增加。与空气的1相比,水或血液的相对电介质常数是大约80。因为电容正比于相对电介质常数,这导致共振频率上的显著偏移。
例如假设导线的共振频率是大约100MHz。在这种情况下,导线电感将是主要的,因为射频波形频率对于1.5T MRI是64MHz。如果血液浸入绕组之间,则将导致自大约100MHz至大约11MHz的导线共振频率偏移。该共振频率现在低于MRI的工作频率(64MHz),在这种情况下绕圈间电容是主要的。在这种情况下,本应通过线圈绕组形成的电感传播的射频能量通过绕圈间电容传播,降低了导线阻抗。注意到工作频率距离共振频率越远,则导线阻抗越低(例如参见图7)。
在一些实施例中,导线14可以具有到在电极44上或附近的周围组织的低阻抗路径和沿着导线长度的高阻抗(例如痕迹阻抗)。例如,在图3所示的实施例中,通过在电极之前44结束外部导体42和/或任意绝缘材料,可以建立在电极44上或附近的较低阻抗。更具体地,图3图示与屏蔽层结合的线路。
根据一些实施例,可以使用薄绝缘体提供在电极44和周围组织之间的高电容。该薄绝缘体还可以提供对于MRI感应射频能量的低阻抗路径。然而,该薄绝缘体通常并不影响用于通常包含具有低频内容能量的治疗发送的阻抗。在某些实施例中,可以将内部导体的阻抗设计得类似于一个或多个外部屏蔽导体42的阻抗。然而,在其它实施例中,内部导体阻抗可能不同于一个或多个外部屏蔽导体42的阻抗。
在各种实施例中,螺旋间距是沿着螺旋轴测量的一个完整螺旋绕圈的宽度。根据各种实施例,内部导体40可以具有在五密耳(即5/1000英寸)和五十密耳(即50/1000英寸)之间(含五密耳和五十密耳)的平均间距。在一些实施例中,内部导体40可以具有大约五密耳的最大间距,而在其它实施例中,最大间距可以更大或更小。在各种实施例中间距变化也可以是线路直径的函数。例如,如果线路直径是3密耳,则最小间距可以略微大于3密耳。如果线路导线是绝缘的和绕圈间电容不大,则在一些实施例中最小间距可以是3密耳。
图6是图示用于图5的线圈螺旋形状导线14的等同电路50的示意图。如图6所示,螺线导线的电感结合其绕组绕圈之间的电容构成沿着导线长度的共振电路50。在MRI程序中接收的射频电磁能量生成电压52。导线14具有电路50内的等同电感和电容,如用“Z_lead(f)”一般表示的。电极与组织的接触点具有如用54表示的等同阻抗。导线14的阻抗“Z_lead(f)”在MRI扫描器的射频频率上在幅度上提高。这例如可以在图7中看出,其图示了在共振频率“F0”上在阻抗幅度上的显著提高。
在某些实施例中,导线和/或导线屏蔽层的间距可以沿着其长度而改变以通过期望的方式改变导线和/或屏蔽层的阻抗特性。间距可以连续地改变或者在固定点上。例如,可以以螺旋状形状形成图8A中的非线圈导线56,具有可以改变的间距以提供一个或多个高阻抗频率相关点。图8B图示一种说明性实施例,其中沿着导线56的长度形成高阻抗频率相关点58、60、62,除了降低射频拾取能量到内部导体的传输之外,还降低了射频拾取能量。在一些实施例中,还可以围绕导线56设置具有可变间距的说明性屏蔽层64,如图8A中进一步图示的。然而,在其它实施例中,导线可以包括具有固定间距的屏蔽层,屏蔽层仅沿着一部分导线,或者导线完全没有外部屏蔽层。
在一些实施例中,沿着导线56的长度多次重复导线间距模式,以便间距模式覆盖低于所关注最高频率的1/4波长的导线长度。例如,对于经受64MHz的射频MRI频率的导线56,可以大约每117厘米,其对应于在该频率上的1/4波长,重复该导线间距模式。在MRI扫描过程中,导线56的这种解谐防止导线56接近天线共振长度,进而最小化自导线56拾取的射频能量。
图9图示在两个不同的射频频率F1和F2上可变间距导线的阻抗与导线长度的关系的两幅图。如图9所示,沿着导线长度出现较高阻抗的位置取决于在该环境内的周围拾取频率F1,F2。因此,对于上部图内图示的频率F1,沿着导线长度出现阻抗增加的位置不同于在下部图中图示的频率F2。这可以通过在图9图示的上部图和下部图内阻抗峰值的偏移看出。
图10图示根据说明性实施例的可变间距导线66。如图10所示,导线66可以包括第一部分68、第二部分70和第三部分72。沿着每个部分68、70、72的间距变化可以符合具体函数。如在图11中可以进一步看出的,例如,导线66的间距可以符合沿着导线长度66正弦地变化的函数。间距变化可以符合其它函数,例如方波或其它此类函数。在图12图示的一种替代实施例中,例如,导线66的间距可以符合修正方波函数。但是,其它的间距配置也是可能的。
在不脱离本发明保护范围的情况下,可以对所讨论的示例实施例进行各种修改和添加。例如,虽然上述实施例提到了具体特征,但是本发明的范围还包括具有不同特征组合的实施例和并不包括全部所述特征的实施例。因此,本发明的范围将包括落入权利要求书保护范围的全部此类替代、修改和变化及其全部等同物。
Claims (24)
1.一种医疗设备,包括:
具有近端部分、远端部分和长度的导线;
其中该导线包括螺旋形状的内部导体;和
其中内部导体间距沿着导线长度连续地改变,构成沿着导线长度的多个高阻抗点,该多个高阻抗点中的每个适合于禁止所吸收的能量在核磁共振成像设备的询问频率上沿着导线长度传输。
2.权利要求1的医疗设备,其中该内部导体至少部分地由一个或多个外部屏蔽导体径向围绕。
3.权利要求2的医疗设备,其中该导线还包括围绕该一个或多个外部屏蔽导体的一个或多个绝缘材料层。
4.权利要求2的医疗设备,其中该一个或多个外部屏蔽导体具有连续改变的间距。
5.权利要求2的医疗设备,其中该内部导体具有小于一个或多个外部屏蔽导体内直径的外直径,在该导线的近端部分和远端部分将内部导体的外直径提高到该一个或多个外部屏蔽导体的内直径。
6.权利要求1的医疗设备,其中在该内部导体的间距内的变化符合正弦函数、修正方波函数、三角函数或锯齿函数。
7.权利要求1的医疗设备,其中在该内部导体的间距内的变化符合等于核磁共振成像设备查询频率1/4波长的固定长度的重复模式。
8.权利要求1的医疗设备,其中该内部导体具有在五密耳和五十密耳之间和包括其的平均间距。
9.权利要求1的医疗设备,其中该内部导体具有不大于约五密耳的间距。
10.权利要求1的医疗设备,其中导线长度在四十厘米和九十厘米之间。
11.权利要求2的医疗设备,其中内部导体的阻抗类似于一个或多个外部屏蔽导体的阻抗。
12.权利要求1的医疗设备,其中导线的远端部分包括电极。
13.权利要求12的医疗设备,其中导线包括在导线的近端部分和远端部分附近的低阻抗绝缘体,使得电磁能量沿着与导线长度相邻的身体组织消散,从而降低电磁能量到电极的能量传输。
14.权利要求13的医疗设备,其中低阻抗绝缘体由具有五至十倍于内部导体电介质常数的相对电介质常数的材料制成。
15.一种可植入医疗设备,包括:
具有耦合至脉冲发生器的近端部分、在病人心脏内植入的远端部分和长度的导线,其中配置该导线以通过内部导体在心脏和脉冲发生器之间传输电信号;
具有类似螺旋形状的内部导体,其具有连续变化的内部导体间距,形成在一个或多个频率上沿着导线长度的一个或多个高阻抗点;和
径向围绕在内部导体至少一部分上的具有类似螺旋形状的外部导体,其中该外部导体具有沿着导线长度在一个或多个位置上改变的外部导体间距。
16.权利要求15的可植入医疗设备,其中外部导体间距连续地改变。
17.权利要求15的可植入医疗设备,其中内部导体间距符合正弦函数或修正方波函数。
18.权利要求15的可植入医疗设备,还包括具有沿着导线长度的高阻抗和沿着横截面的低阻抗的屏蔽层。
19.权利要求15的可植入医疗设备,其中该内部导体的阻抗基本上类似于外部导体的阻抗。
20.权利要求15的可植入医疗设备,其中脉冲发生器是起搏器或心脏除颤器。
21.权利要求15的可植入医疗设备,还包括围绕外部导体和内部导体设置的一个或多个绝缘材料层。
22.一种医疗导线,包括:
具有类似螺旋形状的内部导体,其具有连续变化的内部导体间距,形成在询问频率上沿着导线长度的高阻抗点;和
具有类似螺旋形状和径向围绕在内部导体至少一部分上的外部导体,其中该外部导体具有沿着导线长度在一个或多个位置上改变的外部导体间距。
23.权利要求22的医疗导线,其中外部导体间距连续地改变。
24.权利要求22的医疗导线,其中查询频率在8.53和128兆赫兹的范围内。
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CN113164754B (zh) * | 2020-01-05 | 2023-08-18 | 脉冲动力(北京)医疗科技有限公司 | 可植入心脏设备中的导线状况测试 |
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JP5073829B2 (ja) | 2012-11-14 |
EP2227289B1 (en) | 2015-07-22 |
US8731685B2 (en) | 2014-05-20 |
WO2009076163A2 (en) | 2009-06-18 |
AU2008335462B2 (en) | 2014-02-20 |
WO2009076163A3 (en) | 2009-12-10 |
AU2008335462A1 (en) | 2009-06-18 |
EP2227289A2 (en) | 2010-09-15 |
US20090149933A1 (en) | 2009-06-11 |
JP2011504405A (ja) | 2011-02-10 |
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