CN102655908B - 具有多层导体的mri条件下安全的导线 - Google Patents
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Abstract
可植入医疗导线在MRI条件下展现出减少的发热。该导线包括多层线圈导体,其包括内部线圈层、设置在内部线圈层周围的中间线圈层和设置在中间线圈层周围的外部线圈层。每个线圈层特征在于丝厚、线圈节距或线圈直径中的一个或多个构建为当暴露于MRI辐射时使得线圈导体展现出高的电感。每个线圈层电连接到其他线圈层以提供并联传导路径,从而产生适于去纤颤导线应用的线圈导体电阻。
Description
技术领域
本发明的不同实施方式总体涉及可植入医疗设备。更特别地,本发明的实施方式涉及MRI条件下安全的导线导体。
背景技术
当正常工作时,人类心脏维持其自身固有的节律并能够泵送充足的血液通过身体的循环系统。然而,一些人具有不规则的心脏节律,称为心律失常,这可能导致减少的血液循环和心脏输出。处理心律失常的一种方式包括采用脉冲发生器(PG),例如起搏器、可植入心律转变器去纤颤器(ICD)或者心脏再同步(CRT)设备。这样的设备典型地耦接到多个传导导线上,所述导线具有一个或多个电极,其可以用于将起搏治疗和/或电击传送到心脏。例如在房室(AV)起搏中,导线通常位于心脏的心室和心房中,并经由导线终端针脚附接到植入在胸或腹中的起搏器或去纤颤器上。
磁共振成像(MRI)是非侵入式成像处理,其采用核磁共振技术提供病人身体内的图像。典型地,MRI系统采用磁性线圈,其具有在大约0.2到3特斯拉之间的磁场强度。在处理过程中,身体组织短暂地暴露于在垂直于磁场的平面中的电磁能量的射频(RF)脉冲中。通过测量组织中激发的原子核的驰豫属性,这些脉冲产生的电磁能量可以用于对身体组织成像。在一些情形下,对病人的胸腔区域成像可能是临床上有利的。在胸部MRI处理中,植入的脉冲发生器和导线还可能暴露于施加的电磁场中。
发明内容
本发明的不同实施方式涉及可植入的医疗电导线,其包括多层导体线圈,构建用于当暴露于MRI辐射时最小化热量升高。
在实施方案1中,可植入电导线包括挠性主体、接头组件、电极和多层线圈导体。该挠性主体具有包括近端的近端区域,远端区域,和从近端延伸通过远端区域的纵向主体内腔。该接头组件构建用于机械地和电力地连接该可植入电导线到可植入脉冲发生器上。该电极在远端区域中耦接到挠性主体上,而所述多层线圈导体在所述纵向主体内腔内从所述接头组件延伸到至少所述电极。该多层线圈导体包括第一线圈层,其包括一个或多个丝缠绕以具有紧密的节距,和第二线圈层,其设置在第一线圈层周围,包括一个或多个丝缠绕以具有紧密的节距。第二线圈层的丝以与第一线圈层的丝相同的节距方向缠绕。所述第一和第二线圈层互相电力地耦接并构建用于在所述接头组件和电极之间提供并联的传导路径,从而使得所述多层线圈导体具有大约3到3.5欧姆的最大DC电阻。
在实施方案2中,实施方案1的可植入电导线,其中所述第一线圈层和第二线圈层的丝单独地电绝缘。
在实施方案3中,实施方案1或2的可植入电导线,其中所述第一线圈层的一个或多个丝相互不电绝缘,并且其中所述第二线圈层的一个或多个丝相互不电绝缘,且所述导线还包括至少部分地设置在第一和第二线圈层之间的一层绝缘材料。
在实施方案4中,实施方案1-3中任一个所述的可植入电导线,其中所述第一和第二线圈层的一个或多个丝由拉制填充管(DFT)线制成,其包括银芯和钴镍钼合金外覆层。
在实施方案5中,实施方案1-4中任一个所述的可植入电导线,其中所述第一线圈层的丝具有大约0.001英寸的最大丝厚,并且其中所述第二线圈层的丝具有大约0.003英寸的最大丝厚。
在实施方案6中,实施方案1-5中任一个所述的可植入电导线,还包括设置在第二线圈层周围的第三线圈层,其包括一个或多个丝,所述丝以紧密节距缠绕并且与第一和第二线圈层的丝相同的节距方向缠绕。
在实施方案7中,实施方案1-6中任一个所述的可植入电导线,其中所述第三线圈层具有大约0.004英寸的最大丝厚。
在实施方案8中,实施方案1-7中任一个所述的可植入电导线,其中所述第一线圈层、第二线圈层和第三线圈层的电感是不同的。
在实施方案9中,实施方案1-8中任一个所述的可植入电导线,其中所述第一线圈层和第二线圈层具有1丝、2丝、3丝或4丝的结构。
在实施方案10中,实施方案1-9中任一个所述的可植入电导线,其中所述第一线圈层具有在0.001英寸和0.002英寸之间并包括0.001英寸和0.002英寸的丝厚。
在实施方案11中,实施方案1-9中任一个所述的可植入电导线,其中所述第一线圈层由具有1至4个丝的结构的厚度为0.0007英寸的拉制填充管(DFT)线形成,且第一线圈层的外径小于0.004英寸。
在实施方案12中,实施方案1-11中任一个所述的可植入电导线,其中所述第二线圈层具有在0.0007英寸和0.003英寸之间并包括0.0007英寸和0.003英寸的丝厚。
在实施方案13中,可植入医疗导线,包括挠性主体、接头组件、电极和多层线圈导体。该挠性主体具有包括近端的近端区域,远端区域,和从近端延伸通过远端区域的纵向主体内腔。该接头组件构建用于机械地和电力地连接该可植入医疗导线到可植入脉冲发生器上。该电极在远端区域中耦接到挠性主体上,和所述多层线圈导体在所述纵向主体内腔内从所述接头组件延伸到至少所述电极。该多层线圈导体包括内部线圈导体,其具有外径(OD)、紧密的节距,和顺时针或逆时针的内部线圈节距方向。该多层线圈导体还包括中间线圈导体,其具有紧密的节距、与内部线圈节距方向相同的中间线圈节距方向,大于内部线圈导体的外径的内径(ID),其中该中间线圈导体沿着内部线圈导体的长度径向地围绕该内部线圈导体。该多层线圈导体还包括外部线圈导体,其径向地围绕中间线圈,具有紧密的节距,且具有与内部线圈节距方向相同的外部线圈节距方向。该内部线圈导体、中间线圈导体和外部线圈导体并联地电力耦接,产生大约3.5欧姆的DC电阻。
在实施方案14中,实施方案13的可植入医疗导线,其中所述医疗导线还包括围绕所述内部线圈导体、中间线圈导体或外部线圈导体的一个或多个的一个或多个绝缘材料层。
在实施方案15中,实施方案13或14所述的可植入医疗导线,其中所述内部线圈导体、中间线圈导体或外部线圈导体具有1丝至4丝的结构,且分别具有不同的节距。
在实施方案16中,实施方案13-15中任一个所述的可植入医疗导线,其中所述内部线圈导体具有0.001英寸或更小的丝厚。
在实施方案17中,实施方案13-16中任一个所述的可植入医疗导线,其中所述内部线圈导体由具有1至4个丝的组件和小于0.004英寸的外径的0.0007英寸的拉制填充管(DFT)线形成。
在实施方案18中,实施方案13-17中任一个所述的可植入医疗导线,其中所述外部线圈导体具有在0.0007英寸和0.003英寸之间并包括0.0007英寸和0.003英寸的线径。
在实施方案19中,实施方案13-18中任一个所述的可植入医疗导线,其中所述内部线圈层、中间线圈层和外部线圈层的每个是单独地绝缘的。
附图说明
图1是根据本发明的不同实施方式的包括MRI扫描器和植入在病人躯干内的可植入心脏节律管理系统的医疗系统的示意图;
图2A是根据本发明的一些实施方式,示例的脉冲发生器和可以使用的植入在病人体内的导线的示意图;
图2B是表示用于图2A的导线的简化的等效电路的示意图;
图3是根据本发明的一个或多个实施方式,示出可以采用的示例导线的示意图;
图4是沿着图3的线4-4截得的图3的导线的横截面图;和
图5示例根据本发明的实施方式,用于图3的导线的多层线圈导体的发明细节。
附图不必根据比例绘制。例如,图中一些元件的尺寸可以延伸或减小,以助于促进对本发明实施方式的理解。尽管本发明可以有不同改变和可选形式,具体实施方式通过图中的例子示出并在下面详细地描述。然而,目的不在于将本发明限于描述的特殊的实施方式。相反,本发明旨在覆盖落入本申请权利要求限定出的本发明的范围内的所有变形、等同物和替代物。
具体实施方式
如同下面更详细地解释的,本发明的不同实施方式涉及心脏节律管理(CRM)系统,其结合了新的导线设计,该导线设计有利地适合于在磁共振成像(MRI)环境中运行。在一些实施方式中,包括导体设计的导线构建用于提供合适的电力性能,以传送起搏和/或去纤颤电击治疗,并最小化MRI处理过程中导线对提供的电磁能量的反应。
在下面的说明中,出于解释目的,大量特定细节陈述用于提供对本发明实施方式的彻底理解。然而对本领域技术人员将清楚的是,本发明的实施方式可以在不具有一些这些特定细节的情形下实行。
尽管为了方便参考存在MRI扫描器的IMD而描述一些实施方式,本发明的实施方式可以应用于不同的其他生理学测量、治疗、IMD设备、导线类型和其他非侵入的检查技术,其中导电的导线暴露于时变磁场中。这样,这里讨论的应用不旨在作为限定,而是作为示例。此外,不同的实施方式可应用于传感设备的所有等级,从具有传感器的单一IMD到传感设备的大网络。
图1是医疗系统100的示意图,根据不同实施方式,其包括MRI扫描器、植入在病人120躯干内的可植入心脏节律管理(CRM)系统115和一个或多个外部设备130。外部设备130能够与植入在病人120内的CRM系统115通信。在图1所示的实施方式中,CRM系统115包括脉冲发生器(PG)140和导线150。在正常的设备运行过程中,PG 140构建用于传送电疗刺激到病人心脏160,以提供心动过速心室纤维性颤动、抗心动过缓起搏、抗心动过速起搏、心脏再同步治疗和/或其他类型的治疗。
这样,在示例的实施方式中,PG 140可以是可植入的设备,例如起搏器、ICD、心脏再同步治疗(CRT)设备、具有去纤颤能力的CRT设备(CRT-D设备)或者类似设备。PG 140可以皮下地植入在身体内,典型地在这样的位置,例如在病人胸腔中。在一些实施方式中,PG 140可以植入在腹部中或其附近。
外部设备130可以是本地或远程终端或其他设备(例如计算设备和/或编程设备),其可运行以从病人身体外面的地方与PG 140通信。根据不同的实施方式,外部设备130可以是在病人身体外面的任何设备,其能够进行遥测并与PG 140通信。外部设备的例子可以包括但是不限于编程器(PRM)、家中监测设备、具有遥测设备的个人计算机、具有遥测设备的MRI扫描器、制造测试设备或控制棒。在一些实施方式中,PG 140经由无线通信接口与远程终端130通信。无线通信接口的例子可以包括但是不限于射频(RF)、感应和声音遥测接口。
图2A是CRM系统115的更详细的示意图,其包括植入在病人体内的装备有导线150的示例PG 140。在所描述的实施方式中,CRM系统115包括植入在病人心脏160附近的PG 140和具有植入病人心脏160的远端的导线150。如同从图2A中可以看得的,心脏160包括右心房210、右心室220、左心房230和左心室240。
导线150具有挠性主体200,其包括近端区域205和远端区域250。如同所示的,导线150耦接到PG 140上,而导线体200的远端区域250至少部分地植入在右心室220内的所需位置。如同进一步示出的,导线150包括沿着远端区域250的一对线圈电极255、257,从而当如图2A那样植入时,它们分别位于右心室220和右心房210内。如同下面将更详细地解释和示例的,导线150包括在导线体200内的一个或多个电导体(图2A中未示出),其将电极255、257电力耦接到PG 140内的电路和其他电力组件,以从心脏160传送固有的心脏信号到PG 140,还用于经由电极255、257或其他电极(图2A中未示出)将电击或低压起搏刺激传送到心脏160。
尽管示例的实施方式只描述了插入病人心脏160内的一个导线150,在其他实施方式中,可以采用多个导线,以电力地刺激心脏160的其他区域。在一些实施方式中,例如,第二导线(未示出)的远端可以植入在右心房210中。此外,另一个导线可以植入在冠状静脉系统内,以便于起搏左心室,也即在提供有双心室起搏的CRT或CRT-D系统中,如同本领域已知的那样。除了或代替图1-2所示的导线150,其他类型的导线,例如心外膜导线也可以采用。总之,本发明的不同实施方式预期包括用于CRM系统115中的任何多导线组合和构造,不管是否现在已知或将来开发。
在运行过程中,导线150在心脏160和PG 140之间传送电信号。例如,在PG 140具有起搏能力的那些实施方式中,导线150可以用于传送电疗刺激用以起搏心脏160。在PG 140是ICD的那些实施方式中,导线150可以用于响应于诸如心室纤维性颤动的事件而经由电极255、257将高电压的电击传送到心脏160。
如同下面详细解释的,本发明的不同实施方式涉及新的导线设计,其允许改进在MRI环境中的机械特性和安全运行。在一些实施方式中,以低轮廓的多层线圈导体代替传统的导体电缆。多层线圈导体允许导线设计者在起搏/感应导线应用中维持小的导线轮廓,同时能够更好地控制导线在张紧负载下的轴向延伸。
图2B是表示用于图2A的导线150的简化等效电路260的示意图,表示在导线150上从通过MRI扫描器产生的RF电磁能量采集到的RF能量。如图2B所示,电路260中的电压(Vi)265表示导线150从MRI扫描器采集到的等效能量源。在磁共振成像过程中,导线150的长度功能类似于天线,接收从MRI扫描器传递到身体内的RF能量。图2B中的电压(Vi)265例如可以表示导线150从RF能量中接收到的最终电压。通过导线150采集的RF能量例如可以来自MRI扫描器产生的旋转RF磁场,其在传导组织中在垂直于旋转磁场向量的平面中产生电场。这些电场沿着导线150长度的切向分量耦接到导线150上。电压(Vi)265这样等于沿着导线150长度的切向电场的积分(也即电场的线积分)。
电路260中的ZI参数270表示在MRI扫描器的RF频率处导线150展现的等效阻抗。阻抗值ZI 270例如可以表现为电感或等效阻抗,其产生于并联电感和通过导线150展现的线圈缠绕电感,对于1.5特斯拉的MRI扫描器处于64MHz的RF频率,或者对于3特斯拉的MRI扫描器处于128MHz的频率。导线150的阻抗ZI是具有实部(也即电阻)和虚部(也即电抗)的复数量。
电路260中的Zb 275可以表示身体组织在导线接触点处的阻抗。Zc280依次地可以表示导线150到沿着导线150长度的周围的身体组织的电容耦合,其可以为高频电流(能量)提供路径,以MRI扫描器的RF频率泄漏到周围组织内。最小化吸收的能量(通过源Vi 265表示)减少在导线与身体组织接触点处传送到身体组织的能量。
如同在图2B中进一步可以看得的,导线150在MRI扫描器的RF频率下具有进入周围组织的一定量的泄漏。如通过275进一步指示的,在导线电极255、257到心脏160内的周围身体组织的接触点处还具有阻抗。所产生的传送到身体组织的电压Vb可以通过如下公式表示:
Vb=Vi Zbe/(Zbe+ZI),其中Zbe=Zb与Zc并联。
在导线150典型地与周围组织接触的顶端处的温度部分地与在275处(也即在“Zb”处)消散的能量相关,其依次与Vb的平方相关。为最小化275处消散的能量导致的温度升高,因此想要的是,最小化Vi(265)和Zc(280),同时也最大化导线150的阻抗ZI(270)。在一些实施方式中,导线150的阻抗ZI(270)可以在MRI扫描器的RF频率下减小,这有助于减少在接触点275处消散到周围身体组织内的能量。
在下面更加详细地描述的不同实施方式中,导线150的阻抗可以通过增加到导线150的电感和/或通过合适构建技术而增加。例如,在不同实施方式中,导线150的电感通过选择性地配置用于供应电能到电极255、257的导体而增加。
图3示例了根据本发明的一个或多个实施方式可以采用的更加详细的示例导线150。如图3所示,导线主体200包括近端305,且导线150还包括耦接到导线主体的近端305的接头组件310、线圈电极255、257和在示例的实施方式中用作起搏/感应电极的尖端电极312。根据PG 140(参见图1)的功能要求和病人的治疗要求,导线150的远端区域可以包括额外的电极。例如,在一些实施方式中,线圈电极对255、257可以用于用作电击电极,用于为心脏160提供去纤颤电击。在一些实施方式中,导线150可以包括靠近导线150的远端顶端的低压(例如环形)电极,其也可用作起搏/感应电极,且可以用于补充或替代尖端电极312。总之,在本发明的实施方式的范围内,导线150可以结合有任何数量的电极构造。
在示例的实施方式中,接头组件310包括接头主体320和终端针脚325。接头组件310耦接到导线主体200上并可以构建用于将导线机械地和电力地耦接在PG 140上的连接座(参见图1和图2)。在不同的实施方式中,终端针脚325从接头主体320近端延伸,而在一些实施方式中耦接到内部导体(图3中未示出)上,该内部导体纵向地延伸通过导线主体200到达尖端电极312。在一些实施方式中,终端针脚325可以包括延伸通过其中以与内腔连通的孔,该内腔通过内部导体线圈限定出,用于容纳引导线或插入探针。
在不同的实施方式中,尖端电极312是在导线150的远端处的电作动固定螺旋的形式。在一些实施方式中,尖端电极312可以是通过机构支撑的可伸展/可收缩螺旋,以便于当螺旋旋转时,螺旋相对于导线主体进行纵向平移。在那些实施方式中,终端针脚325可以相对于接头主体320和导线主体200旋转,从而使得终端针脚325相对于导线主体200的旋转引起内部导体进而螺旋形尖端电极相对于导线主体200旋转和纵向地平移。用于提供可伸展/可收缩的固定螺旋组件(电作动和被动)的不同机构和技术对于本领域技术人员来说的已知的,而无需在这里更加详细地描述。
起搏/感应电极(不管是上面所述的固实的尖端电极还是例如图3所示的主动固定螺旋)可以由任何合适的导电材料制成,例如埃尔吉洛伊非磁性合金(Elgiloy)、MP35N、钨、钽、铱、铂、钛、钯、不锈钢和任何这些材料的合金。
线圈电极255、257可以采取任何适于传送相对较高电压的治疗电击到心脏的构造,以进行去纤颤治疗。在不同实施方式中,线圈电极255、257可以由任何合适的导电材料制成,例如在前面段落中讨论的那些。导线150还包括在导线主体200内的导体(图3中未示出),以将线圈电极255、257电连接到在接头组件310上的电接触上,该接头组件依次构建用于将线圈电极255、257电耦接到PG 140内的电力组件上。
在图4中的是沿着图3的线4-4截取的导线150的横向的横截面图。如图4所示,导线主体200包括内部管状件380和设置在内部管状件上并粘合到内部管状件380上的外部管状件385。管状件380、385可以由任何数量的挠性的、生物相容的绝缘材料制成,包括但是不限于聚合物,例如硅树脂和聚亚氨脂及其共聚物。如同进一步所示的,内部管状件380包括多个内腔390、395、400,且导体410、415和420分别设置在内腔390、395和400中。每个导体410、415和420纵向地延伸在各个内腔390、395和400内,并电耦接到电极(例如图3中的电极312、255或257)上,还耦接到接头组件310的电接触上。
在一些实施方式中,导线主体200不包括分开的、同轴的管状件,但是替代地只包括单个管状件(例如件380),其包括用于容纳必需的导体的一个或多个纵向内腔。出于示例目的,内部管状件380的三个内腔390、395、400示出为具有不同的直径。然而在其他实施方式中,内腔390、395、400的相对尺寸和/或方位可以不同于所示的。此外,内部管状件380可以包括更多或更少数量的内腔,这依赖于导线150的特殊构造。例如,内部管状件380可以包括更大数量的内腔,以在导线150内容纳额外的导体线和/或电极线圈,用于提供电流到其他电击线圈和/或起搏/感应电极。
在示例的实施方式中,导体410是单层线圈导体,例如将用于与传统的低压起搏/感应电极、例如尖端电极312连接。在一些实施方式中,例如,线圈导体410构建用于当暴露于电磁能量中,例如在MRI扫描中呈现的电磁能量中时具有相对较高的阻抗。在不同的这样的实施方式中,线圈导体410根据例如在美国专利申请公开第2009/0198314号中所述的不同实施方式而构建,该公开通过参考整个地结合于此。增加的阻抗有助于减少消散到在导线电极处或其附近的周围身体组织中的能量。在不同实施方式中,导体410和内腔390可以省略。
如在下面更加详细地解释的,导体415和420是结合在导线150内的多层导体组件,以提供条件安全的MRI兼容的导线设计,并在传送过程中和在慢性操作条件下提供改进的耐疲劳性和其他机械属性。在不同实施方式中,多层线圈导体415、420包括具有选择性地控制的线圈属性(例如节距、外径、丝的厚度等)的多线圈层,以制造高感应、高导电性、小直径的导体,其具有用于刺激/感应导线主体的合适的机械特性。
在示例的实施方式中,线圈导体415是三层导体,而线圈导体420是两层导体。在不同的实施方式中,可以使用采用多于三个线圈层的多层线圈导体。在不同实施方式中,可以用类似于或等同于线圈导体415和/或420的多层线圈导体替代单层线圈导体410。
图5是根据本发明一个实施方式的线圈导体420的更详细的侧视图。如图5所示,多层线圈导体420是包括外部线圈层422、中间线圈层425和内部线圈层430的三层线圈导体420。外部线圈层422设置在中间线圈层425周围,而中间线圈层设置在内部线圈层430周围。外部、中间和内部线圈层422、425、430至少在它们的近端处(也即在接头组件处或其附近)和它们的远端(也即在电极255处)互相并联地电耦接,从而在接头组件310和电极255之间提供并联的传导路径。在不同实施方式中,线圈层422、425和430的参数这样构建,使得多层线圈导体420具有大约3.0-3.5欧姆的最大DC电阻,而在暴露于特征在于具有与MRI扫描相关的频率的外部交流磁场时具有更高的阻抗。可以理解的是,两层线圈导体415可以以与图5所示的线圈导体420基本相同的方式构建,而只包括两个线圈导体层。
在一些实施方式中,线圈导体420的外层422可以缠绕到小于约0.013英寸的线圈直径D0上。在一些实施方式中,外层具有紧密的节距,并可以具有一个或多个丝,所述丝具有大约0.004英寸的最大丝厚。根据不同实施方式,取决于导线的所需应用,可以或可以不设置外层。例如,在一些情形下,外层可以用于改变多层线圈导体420的电阻。在至少一个实施方式中,外层422可以具有从大约0.001到大约0.004英寸的丝厚。
线圈导体420的中间层425具有紧密的节距,并可以缠绕到小于外部线圈层422的内径的线圈直径Dm上。在一些实施方式中,中间层可以具有一个或多个丝,所述丝具有从大约0.0007到大约0.003英寸的最大丝厚。
线圈导体420的内部线圈层430具有紧密的节距,并可以缠绕到小于中间线圈层425的内径的线圈直径Di上。在一些实施方式中,内层可以具有一个或多个丝,所述丝具有从大约0.0007到大约0.001英寸的最大丝厚。
在不同的其他实施方式中,多层线圈导体420根据导线150的运行需要,对各个线圈层422、425、430采用不同范围的尺寸和其他参数(例如丝的数量)。
在不同实施方式中,丝的材料可以是展现想要的电力和机械属性的任何合适的材料。在一个实施方式中,外部、中间和/或内部线圈层422、425、430的丝由包括具有MP35N或钽覆层的银芯(约40%)的拉制填充管(DFT)线制成。在另一个实施方式中,外、中和/或内部线圈层422、425、430由包括具有MP35N覆层的钽芯的DFT线制成。线圈层422、425、430可以包括相同或不同的材料,且线圈层422、425、430的每个可以包括不同的银填充水平。
在不同实施方式中,线圈导体420的每个层的丝以相同的节距方向缠绕。也即,当沿着其纵向轴线观察时,每个线圈层的单个丝缠绕为具有右手节距或者具有左手节距。
在不同实施方式中,一个或多个线圈层422、425、430沿着其长度具有不同线圈节距,这用于解谐线圈导体420,以减小外部地施加的电磁辐射的作用(也即由于MRI胸腔扫描)。
在不同实施方式中,单独的线圈层422、425、430可以单独地最优化地,使得每个展现不同的电感,例如通过改变丝厚、节距和/或线圈层直径,以进一步改变MRI条件下导线150的性能。
本发明的一些实施方式包括在一个或多个邻接线圈层422、425或430之间的一个或多个绝缘层。可选地或附加地,在不同实施方式中,单独的丝或线圈层422、425和/或430单独地绝缘。如果需要的话可以采用任何合适的绝缘材料。用于丝和/或线圈层之间的示例的绝缘材料包括乙烯-四氟乙烯共聚物(ETFE)、聚四氟乙烯(PTFE)、膨胀PTFE(ePTFE)、硅树脂和前述材料的共聚物。
上面所述的导线150的不同实施方式有利地最小化了暴露于外部MRI电磁场导致的导线导体中的感应电流。这与传统的导线系统形成对比,后者采用绞合电缆导体从PG传送电击电流到电击电极。尽管这样的电缆导体提供了良好的电力性能以提供抗心动过速治疗,绞合电缆导体还具有低阻抗,从而当暴露于交变电磁场时——例如在MRI扫描中出现——易于产生感应电流。本发明的不同实施方式在暴露于MRI辐射时可以使导线150展现温升,该温升大约是采用传统高能电缆时的一半,所述传统高能电缆传统地用于在去纤颤中提供能量到高压电击线圈。上述用于导线150的高阻抗导体构造最小化了MRI辐射的作用,同时仍然提供合适的电力性能用于抗心动过速治疗应用中。
此外,根据一些实施方式,多层线圈导体的设计参数可以调整以用于控制机械性能,例如有效弹簧常数进而控制整个导线组件的刚度、弯曲刚度等。这样的调整在低压和高压导线应用中,可以使得使用者能够最小化在相邻(远端)的聚合物组件上的应力(负载),最小化剪切粘结破坏的可能性,便利/控制导线偏置形状,并最小化组装过程中累积的轴向长度公差的影响。例如,在不同实施方式中,电击线圈255、257(参见图2A和3)可以省略,导线150只包括一个或多个低压起搏/感应电极,例如尖端电极312和沿着导线150的额外的环电极。在这样的实施方式中,相对于相邻的绝缘组件例如导线主体200,多层线圈导体例如线圈导体425和/或420可以用于在低轮廓设计中提供足够的电力性能以及最优的机械特性,例如轴向刚度。
在不同实施方式中,多层线圈导体415和/或420可以调整用于控制线圈导体415和/或420的有效弹簧常数(表达为每单位长度的力),从而减小或排除导体线圈和相邻的绝缘元件(也即导线主体200组件)之间的轴向刚度的差别。通过这样控制和最优化线圈导体弹簧常数/轴向刚度,聚合物导线主体组件的整个轴向强度可以保持,例如在线圈导体415、420靠近导线主体组件终止的地方。此外,通过减小或排除导体的轴向刚度的大的差异(也即通过采用多层线圈导体415和/或420)和并联的聚合物导线主体组件,这些元件之间的剪切力有利地得以减小。采用多层线圈导体415、420替代导体电缆也排除了导体的蛇形曲折,该蛇形曲折可能由在导体上的拉伸轴向负载的收缩和释放导致。
可以改变以调整/最优化上述机械特性的示例设计参数可以包括但是不限于导体材料的选择、层的数量、线圈几何形状、节距、丝径、丝的数量和其他。
除了上述线圈导体构造,本发明的导线150的不同实施方式可选地可以结合有其他特征或技术,以最小化MRI辐射作用。例如,在一些实施方式中,屏蔽物可以添加到导线150上以进一步减少从导线150获得的电磁能量的量。例如,从屏蔽物上获得的能量可以沿着导线150的长度耦接到病人身体上,防止能量耦接到导线顶端上。通过屏蔽物截取的能量沿着屏蔽物/导线的传送还可以通过将能量作为电阻损耗消散而得到抑制,其中采用电阻材料作为屏蔽结构。
在不脱离本发明的范围的情况下可以对讨论的示例的实施方式作出不同的变形和增加。例如,尽管上述实施方式指示了特定特征,本发明的范围还包括具有不同特征组合的实施方式和不包括所有所述特征的实施方式。相应地,本发明的范围旨在覆盖落入权利要求的范围及其所有等价物的所有这样的替代、变形和改变。
Claims (19)
1.可植入电导线,包括:
挠性主体,其具有包括近端的近端区域,远端区域,和从近端延伸通过远端区域的纵向主体内腔;
接头组件,其构建用于机械地和电力地连接该可植入电导线到可植入脉冲发生器上;
在远端区域中耦接到挠性主体上的电极;和
多层线圈导体,其在所述纵向主体内腔内从在所述接头组件处的近端延伸到至少在所述电极处的远端,该多层线圈导体包括:
第一线圈层,其包括从所述近端到所述远端的一个或多个丝缠绕以具有紧密的节距;和
第二线圈层,其从所述近端到所述远端设置在第一线圈层周围,并包括一个或多个丝缠绕以具有紧密的节距,第二线圈层的丝以与第一线圈层的丝相同的节距方向缠绕;和
其中所述第一线圈层和第二线圈层互相电力地耦接并构建用于在所述接头组件和电极之间提供并联的传导路径,从而使得所述多层线圈导体具有3到3.5欧姆的最大直流电阻。
2.根据权利要求1所述的可植入电导线,其中所述第一线圈层和第二线圈层的丝各自电绝缘。
3.根据权利要求1所述的可植入电导线,其中所述第一线圈层的一个或多个丝相互不电绝缘,并且其中所述第二线圈层的一个或多个丝相互不电绝缘,且所述导线还包括至少部分地设置在第一线圈层和第二线圈层之间的一层绝缘材料。
4.根据权利要求1所述的可植入电导线,其中所述第一线圈层和第二线圈层的一个或多个丝由拉制填充管线制成,其包括银芯和钴镍钼合金外覆层。
5.根据权利要求1所述的可植入电导线,其中所述第一线圈层的丝具有0.001英寸的最大丝厚,并且其中所述第二线圈层的丝具有0.003英寸的最大丝厚。
6.根据权利要求1所述的可植入电导线,还包括设置在第二线圈层周围的第三线圈层,其包括一个或多个丝以紧密节距缠绕并且与第一线圈层和第二线圈层的丝相同的节距方向缠绕。
7.根据权利要求6所述的可植入电导线,其中所述第三线圈层具有0.004英寸的最大丝厚。
8.根据权利要求7所述的可植入电导线,其中所述第一线圈层、第二线圈层和第三线圈层的电感是不同的。
9.根据权利要求1所述的可植入电导线,其中所述第一线圈层和第二线圈层具有1丝、2丝、3丝或4丝的结构。
10.根据权利要求1所述的可植入电导线,其中所述第一线圈层具有在0.001英寸和0.002英寸之间并包括0.001英寸和0.002英寸的丝厚。
11.根据权利要求1所述的可植入电导线,其中所述第一线圈层由具有1丝至4丝的结构的0.0007英寸的拉制填充管线形成,且第一线圈层的外径小于0.004英寸。
12.根据权利要求11所述的可植入电导线,其中所述第二线圈层具有在0.0007英寸和0.003英寸之间并包括0.0007英寸和0.003英寸的丝厚。
13.可植入医疗导线,包括:
挠性主体,其具有包括近端的近端区域,远端区域,和从近端延伸通过远端区域的纵向主体内腔;
接头组件,其构建用于机械地和电力地连接该可植入医疗导线到可植入脉冲发生器上;
在远端区域中耦接到挠性主体上的电极;和
多层线圈导体,其在所述纵向主体内腔内延伸,所述多层线圈导体从在所述接头组件处的近端延伸到至少在所述电极处的远端,该多层线圈导体包括:
内部线圈导体,其具有外径、紧密的节距,和顺时针或逆时针的内部线圈节距方向;
中间线圈导体,其具有紧密的节距、与内部线圈节距方向相同的中间线圈节距方向,大于内部线圈导体的外径的内径,并且其中该中间线圈导体沿着内部线圈导体的长度径向地从所述近端到所述远端围绕该内部线圈导体;和
外部线圈导体,其径向地从所述近端到所述远端围绕中间线圈导体,所述外部线圈导体具有紧密的节距,且具有与内部线圈节距方向相同的外部线圈节距方向;和
其中该内部线圈导体、中间线圈导体和外部线圈导体并联地电力耦接,产生3.5欧姆的直流电阻。
14.根据权利要求13所述的可植入医疗导线,其中所述医疗导线还包括围绕所述内部线圈导体、中间线圈导体或外部线圈导体中的一个或多个的一个或多个绝缘材料层。
15.根据权利要求13所述的可植入医疗导线,其中所述内部线圈导体、中间线圈导体或外部线圈导体具有1至4个丝的结构,且分别具有不同的节距。
16.根据权利要求13所述的可植入医疗导线,其中所述内部线圈导体具有0.001英寸的最大丝厚。
17.根据权利要求16所述的可植入医疗导线,其中所述内部线圈导体由0.0007英寸的拉制填充管线形成,所述拉制填充管线具有1丝至4丝的组件和小于0.004英寸的外径。
18.根据权利要求17所述的可植入医疗导线,其中所述外部线圈导体具有在0.0007英寸和0.003英寸之间并包括0.0007英寸和0.003英寸的线径。
19.根据权利要求13所述的可植入医疗导线,其中每个内部线圈层、中间线圈层和外部线圈层都是各自绝缘的。
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2010
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- 2010-11-05 EP EP10778789.7A patent/EP2519305B1/en not_active Not-in-force
- 2010-11-05 AU AU2010337313A patent/AU2010337313B2/en not_active Ceased
- 2010-11-05 JP JP2012547075A patent/JP5542217B2/ja not_active Expired - Fee Related
- 2010-11-05 CN CN201080056719.7A patent/CN102655908B/zh not_active Expired - Fee Related
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2014
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EP2519305B1 (en) | 2017-07-05 |
JP5542217B2 (ja) | 2014-07-09 |
US20140324139A1 (en) | 2014-10-30 |
EP2519305A1 (en) | 2012-11-07 |
US9199077B2 (en) | 2015-12-01 |
US8798767B2 (en) | 2014-08-05 |
US20110160829A1 (en) | 2011-06-30 |
AU2010337313B2 (en) | 2014-04-24 |
CN102655908A (zh) | 2012-09-05 |
WO2011081713A1 (en) | 2011-07-07 |
AU2010337313A1 (en) | 2012-05-03 |
JP2013516223A (ja) | 2013-05-13 |
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