CN102802723B - 具有改善的力矩传送容量且减少mri发热的带有单细丝线圈的医疗设备导线 - Google Patents

具有改善的力矩传送容量且减少mri发热的带有单细丝线圈的医疗设备导线 Download PDF

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CN102802723B
CN102802723B CN201080027308.5A CN201080027308A CN102802723B CN 102802723 B CN102802723 B CN 102802723B CN 201080027308 A CN201080027308 A CN 201080027308A CN 102802723 B CN102802723 B CN 102802723B
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wound conductors
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device lead
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CN102802723A (zh
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克里斯多夫·派瑞
布莱恩·A·克拉克
阿瑟·J·福斯特
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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
    • 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

一种用于医疗设备的导体组件，其中包括含具有圈节距和外径的多个匝并且由具有丝径的一根细丝组成的螺旋卷绕导体。根据该丝径选择圈节距和外径，以便存在MRI场时该螺旋卷绕导体的发热最小。在该螺旋卷绕导体周围形成聚合物外皮，使单细丝螺旋卷绕导体的圈节距得以保持。该聚合物外皮被设置成以增加螺旋卷绕导体的力矩传送容量。

Description

具有改善的力矩传送容量且减少MRI发热的带有单细丝线圈的医疗设备导线
技术领域
本发明涉及可植入医疗设备。具体而言，本发明涉及包含带有聚合物外皮的单细丝线圈的医疗设备导线结构。
背景技术
已熟知用电刺激处理各种医疗状态的可植入医疗设备。可植入医疗设备一般包含医疗电线，用于将电刺激传送到病人体内目标处，诸如病人的心脏或神经系统。该导线一般具有细长、柔韧的绝缘体、通过该体内形成的管腔延伸的一根或多根内导体，以及连接到该导体远端的一个或多个裸露电极。
可在静脉到达处将导线导入病人的血管，并贯通静脉地经静脉引导到要植入电极的部位或目标治疗处的接触组织。连在导体近端的脉冲发生器经一根或多根导体对目标处传送电刺激治疗。
发明内容
一种用于医疗设备的导体组件，其中包括含具有圈节距和外径的多个匝并且由具有丝径的一根细丝组成的一个螺旋卷绕导体。圈节距为丝径的约一至二倍，外径至少是圈节距的4.5倍，以便存在MRI场时该螺旋卷绕导体的发热最小。在该螺旋卷绕导体周围形成聚合物外皮，使单细丝螺旋卷绕导体的圈节距得以保持。该聚合物外皮被设置成以增加螺旋卷绕导体的力矩传送容量。一示范实施例中，医疗设备导线包括含至少一个电极的绝缘导线体，并将螺旋卷绕导体电耦合到该至少一个电极。
另一本发明实施例中，螺旋卷绕导体根据丝径选择圈节距和外径，以便存在MRI场时该螺旋卷绕导体的发热最小。在该螺旋卷绕导体周围形成聚合物外皮，使单细丝螺旋卷绕导体的圈节距得以保持。按一种图案沿聚合物外皮的一段长度切除该聚合物外皮，该聚合物外皮增大螺旋卷绕导体的力矩传送容量。
虽然揭示多个实施例，但根据记录并描述本发明示意性实施例的下列详述，本发明的其它实施方式对本领域技术人员是显而易见的。因而，说明书附图和详述应看作本发明的说明，而非限制。
附图说明
图1是包括耦合到置入病人心脏内的脉冲发生器的心率管理系统的示意图。
图2A是根据本发明一实施例的包括单细丝传导线圈和聚合物外皮的导体组件的立体图。
图2B是图2A所示导体组件的截面图。
图3A是根据本发明另一实施例的包括部分切除的聚合物外皮的导体组件的截面图。
图3B是图3A所示导体组件的平面图。
图4是根据本发明另一实施例的包括按支架图案切除的聚合物外皮的导体组件的平面图。
本发明可以进行各种修改和形式替换，以附图中实例的方式示出了具体实施例，并在下文详述。然而，本发明无意将发明限制于所述的特定实施例。反之，本发明意在覆盖落入所附权利要求书规定的发明范围内的全部修改、等同和替换。
具体实施方式
图1是心率管理系统10的示意图，该系统包括可植入医疗设备(IMD)12和具有近端16和远端18导线14。一实施例中，IMD12包括一个脉冲发生器，诸如起搏器或去纤颤器。IMD12皮下植入体内，通常植入在诸如病人胸部或腹部的位置，尽管其它植入位置也可。导线14的近端16可以接到IMD12，或与IMD12形成为一体。反过来，在心脏20内或附近的所需位置可以植入导线14的远端18。
如图1所示，将导线14的远端部分设置在病人的心脏20中，该心脏包括右心房22、右心室24、左心房26和左心室28。图1所示实施例中，贯通静脉地引导导线14的远端18，使其穿过右心房22，通过冠状窦门29，进入冠状窦31或大心血管33的分支。导线14的图示位置能用于传感或给心脏20的左侧输送起搏和/或去纤颤能量，或者处理输送到心脏20的左侧的心率不齐或其它要求治疗的心脏病。另外，可以理解：导线14可以用于在心脏20的其它区域(例如右心室24)进行治疗。
虽然说明性实施例仅描述单根植入的导线14，但应明白：可以使用多根导线，以便电刺激心脏20的其它区域。有些实施例中，例如，可将第二导线(未示出)的远端植入右心房22，并且/或者可在右心室24植入第三导线(未示出)的远端。除图1中描述的导线14外，还能利用例如心外膜导线等其它类型的导线，或者使这些导线代替导线14。
操作时，导线14设置成在IMD12与心脏20之间输送电信号。例如，在IMD12是起搏器的实施例中，导线14用于传送心脏20起搏用的电刺激。在IMD12是可植入的心脏去纤颤器的实施例中，导线14用于响应诸如心脏病突发或心律不齐的事件，对心脏20传送电击。有些实施例中，IMD12包括起搏和去纤颤两种性能。
由贯穿导线14延伸的一个或多个导体从远端18在IMD12与电极之间载送电信号。将该一个或多个导体在导线14的近端16电耦合到适合与IMD12接口的连接器，并且在远端18电耦合到一个或多个电极。根据本发明，螺旋卷绕一个或多个导体，使其包含具有圈节距和外径的多个匝，并且由具有丝径的一根细丝构成。根据该丝径选择圈节距和外径，以便磁共振成像(MRI)扫描对导线14的功能和运作的影响最小。在该螺旋卷绕导体周围形成聚合物外皮，使单细丝螺旋卷绕导体的圈节距得以保持。另外该聚合物外皮被设置成以增加螺旋卷绕导体的力矩传送容量。
图2A和图2B分别是根据本发明的导体组件50的立体图和截面图。导体组件50贯穿导线14的内部延伸，包括线圈52和共聚物外皮54。将线圈52在导线14的近端16经连接器耦合到IMD12，在导线14的远端18耦合到一个或多个电极。虽然图2A和图2B中示出单个的线圈52，但导体组件50可以设置成使其包括多个线圈52，各线圈能从远端18在IMD12与电极之间传送信号。
线圈52包括围绕导体组件50的纵轴螺旋缠卷的单根细丝56。细丝56具有直径d。管腔58贯穿线圈52的中心延伸，适合于接纳输送导线14的工具，诸如引导线或支撑管。线圈52包括具有外径OD和内径ID的多个匝。线圈52还具有圈节距p，该节距从线圈52的一个匝的中央延伸到线圈52的相邻匝的中央。
导线14暴露到磁共振成像(MRI)的场，由于导线的导体(例如线圈52)的激发，会导致远端18上的电极的局部发热。具有高电感(＞1μH)的导体在MRI场中抗激发较强。导体的几何特性决定其电感，该特性包括导体是伸直的还是卷绕的。对卷绕或缠卷的导体(如线圈52)而言，若干参数影响其电感，这些参数包括线圈52的圈节距p、外径OD、截面面积和构成该线圈的细丝的数量。因而，可选择线圈52的尺寸，使磁共振成像(MRI)场对导线14的性能和响应的影响最小。例如，对包括一个单细丝线圈52的所示导体组件50而言，圈节距p在约1个至2个丝径d的范围，并且外径OD至少为圈节距p的约4.5倍，则该线圈的电感增大到足以使线圈52检出的能量最小。
下面的表1提供使MRI场引起的电极发热最小的线圈52的尺寸。所列的尺寸用于长度(从连接器到远端18)在约450毫米至约600毫米的范围的线圈52。
表1
这些尺寸适合包括一个单细丝线圈52的导体组件50。所列丝径d、圈节距p和线圈外径OD的尺寸仅作为例子，也期待使归因于MRI场的电极发热减小到合适程度的其它尺寸。此外，对于包括多个同轴单细丝线圈的导体组件50，这些尺寸可改变，以补偿存在MRI场时该线圈的相互作用。
外径OD小且节距p小的线圈52在构造和使用时容易损坏。例如，有源固定导线中，打算使线圈52相对于导线体旋转并驱动力矩，以便固定螺旋线伸入心脏20的组织。单细丝线圈(如线圈52)传送力矩常欠佳，因而导线14一般受到的力能使线圈52在其一些部分遭到应力集中，会导致线圈52过早疲劳。为了改善线圈52的力矩传送容量和保持圈节距p的完整，围绕线圈52形成聚合物外皮54，使该聚合物外皮54覆盖或包裹线圈52。
可在线圈52上形成共聚物外皮54，使其一部分在线圈52的匝之间展开，以便线匝相互保持适当的间隔。有些实施例中，聚合物外皮54是在制造时拉盖线圈52的套管。其它实施例中，将共聚物外皮54被挤压、模塑、粘合或热套在线圈52上。可在带有开放管腔58的线圈52上形成共聚物外皮54。或者，可在绝缘材料管或圆筒周围卷绕线圈52，随后在线圈52的周围形成共聚物外皮54。
共聚物外皮54足够厚，并且由足够硬的材料构成，以增加力矩传送容量和保持线圈52的圈节距p，同时还使导体组件50在使用时可充分屈曲。有些实施例中，共聚物外皮54的厚度t小于约0.002英寸，并由选自多孔聚四氟乙烯(ePTFE)、叠层ePTFE、聚四氟乙烯(PTFE)、乙烯/四氟乙烯共聚物(ETFE)、氟化乙烯丙烯(FEP)、硅酮、聚氨酯、硅酮-聚氨酯共聚物和多孔聚合物所构成的组的材料组成。可以理解：其它材料和其它厚度t也可。
共聚物外皮54可以粘合到线圈52的一些部分，以防共聚物外皮54从线圈52上剥离。通常在线圈52上形成共聚物外皮54前，对该线圈敷设粘合材料，来实现这一点。然而，有些情况中，聚合物外皮54用的材料对线圈52用的材料粘合欠佳。为了确保粘合良好，可用与聚合物外皮54粘结良好的材料覆盖线圈52。例如，可在细丝56卷绕成线圈52前，使其覆盖合适的聚合物。或者，通过例如激光蚀刻来蚀刻线圈52，使其具有与聚合物外皮54粘结良好的图案。
有些情况中，可修改共聚物外皮54的一些部分，以增加共聚物外皮54的柔韧性。例如，J状导线中，该导线在J状部分的位置具有深弯曲。共聚物外皮54与传导线圈52的某些材料之间在此深弯曲处的相互作用可使导体组件50保持J状，免除植入时J状部分的操作。
图3A和图3B分别是根据本发明另一实施例的导体组件60的截面图和平面图，该实施例包括改善导体组件60的柔韧性的特征。此导体组件60包括具有与上文图2A和图2B分别讨论的线圈52和共聚物外皮54实质上相同材料和尺寸特性的线圈62和共聚物外皮64。此实施例中，按切除图案70沿导体组件60的至少一部分的一段长度切除共聚物外皮64。按切除部分不完全去除共聚物外皮64(即不露出线圈52)的方式部分切除共聚物外皮64。例如，J状导线中，可在J状部分沿深弯处的内径部分切除共聚物外皮64。在改善导体组件60的柔韧性的同时，各部分切除处留下的共聚物外皮64的厚度适用于保持线圈62的节距p和改善线圈62的力矩传送容量。
所示实施例中，切除图案70是围绕共聚物外皮64缠卷的螺旋图案，并且部分切除约20％共聚物外皮64。然而，可以理解：切除图案70可包含任何形式，并且可切除任何百分比的共聚物外皮64，以改善导体组件60的柔韧性，同时还保持圈节距p，并改善导体组件60的力矩传送容量。
可使用各种技术按切除图案70部分切除共聚物外皮64。有些实施例中，在线圈62上形成无修改的共聚物外皮64，随后将其修改成所需图案。可通过例如激光切割在共聚物外皮64中切除图案70，形成该切除图案70。或者，可通过在共聚物外皮64中蚀刻或研磨切除图案70，形成该切除图案70。
图4是根据本发明另一实施例的导体组件80的平面图。此导体组件80包括与上文就图2A和图2B分别讨论的线圈52和共聚物外皮54具有实质上相同材料和尺寸特性的线圈62和共聚物外皮84。此实施例中，沿导体组件80的至少一部分的一段长度将共聚物外皮84切成支架图案90。支架图案90实质上包括菱形切除部分92和未切除部分94。有些实施例中，切除部分92为未完全贯穿共聚物外皮84的厚度t的部分切除。其它实施例中，完全贯穿共聚物外皮84厚度t地切除该切除部分92。
综上所述，本发明涉及一种用于医疗设备的导体组件，其中包括含具有圈节距和外径的多个匝并且由具有丝径的一根细丝组成的螺旋卷绕导体。根据该丝径选择圈节距和外径，以便存在MRI场时该螺旋卷绕导体的发热最小。有些实施例中，圈节距为丝径的约一至二倍，外径至少是圈节距的4.5倍。在该螺旋卷绕导体周围聚合物外皮，使单细丝螺旋卷绕导体的圈节距得以保持。该聚合物外皮被设置成以增加螺旋卷绕导体的力矩传送容量。有些实施例中，按一种图案沿聚合物外皮的一段长度切除该聚合物外皮，该聚合物外皮增大螺旋卷绕导体的力矩传送容量。在一示范实施例中，医疗设备导线包括带有至少一个电极的绝缘导线体，并螺旋卷绕导体电耦合到该至少一个电极。
不偏离本发明范围内，对所讨论的示范实施例作出各种修改和补充。例如，尽管上述实施例涉及一些具体特征，本发明的范围还包括具有不同特征组合的实施例和不包括全部上述特征的实施例。因而，本发明的范围意图包含落入权利要求书范围内的全部替换、修改、变动，以及全部等同。

Claims (22)

1.一种医疗设备导线，其特征在于，包含以下各部分：
包括至少一个电极的一个绝缘导线体；
具有一段长度且与至少一个电极电耦合的螺旋卷绕导体，该螺旋卷绕导体包括围绕导体的纵轴螺旋缠卷的多个匝，该螺旋卷绕导体具有沿该段长度的圈节距和外径，该螺旋卷绕导体由具有丝径的一根细丝组成，其中圈节距为丝径的一至二倍，外径至少是圈节距的4.5倍，以便存在MRI场时该螺旋卷绕导体的发热最小；
聚合物外皮，形成在该螺旋卷绕导体上，使单细丝螺旋卷绕导体的圈节距以及所述外径沿该段长度得以保持，其中该聚合物外皮被设置成以增加螺旋卷绕导体的力矩传送容量。
2.根据权利要求1所述的医疗设备导线，其特征在于，沿聚合物外皮的一段长度以一种图案切除该聚合物外皮，以在各部分切除处增加导体组件的柔韧性。
3.根据权利要求1所述的医疗设备导线，其特征在于，以促进聚合物外皮与该螺旋卷绕导体之间粘合的材料覆盖该螺旋卷绕导体。
4.根据权利要求1所述的医疗设备导线，其特征在于，蚀刻该螺旋卷绕导体的表面，以促进与聚合物外皮粘合。
5.根据权利要求1所述的医疗设备导线，其特征在于，聚合物外皮由选自聚四氟乙烯(PTFE)、乙烯/四氟乙烯共聚物(ETFE)、氟化乙烯丙烯(FEP)、硅酮、聚氨酯、硅酮一聚氨酯共聚物和多孔聚合物所构成的组中的一种或几种材料组成。
6.根据权利要求1所述的医疗设备导线，其特征在于，聚合物外皮由选自多孔聚四氟乙烯(ePTFE)和叠层多孔聚四氟乙烯所构成的组中的一种或几种的材料组成。
7.根据权利要求1所述的医疗设备导线，其特征在于，丝径小于0.127毫米，外径小于0.889毫米。
8.根据权利要求1所述的医疗设备导线，其特征在于，聚合物外皮的厚度小于0.051毫米。
9.一种医疗设备导线，其特征在于，包含以下各部分：
包括至少一个电极的一个绝缘导线体；
与至少一个电极电耦合的螺旋卷绕导体，该螺旋卷绕导体包括围绕导体的纵轴螺旋缠卷的多个匝，该螺旋卷绕导体具有圈节距和外径，该螺旋卷绕导体由具有丝径的一根细丝组成，其中根据丝径选择圈节距和外径，以便存在MRI场时该螺旋卷绕导体的发热最小，并且其中所述圈节距为丝径的一至二倍；和
聚合物外皮，形成在该螺旋卷绕导体上，使单细丝螺旋卷绕导体的圈节距得以保持，其中沿聚合物外皮的一段长度以一种图案切除该聚合物外皮，以在各部分切除处增加聚合物外皮的柔韧性。
10.根据权利要求9所述的医疗设备导线，其特征在于，外径至少是圈节距的4.5倍。
11.根据权利要求9所述的医疗设备导线，其特征在于，以促进聚合物外皮与该螺旋卷绕导体之间粘合的材料覆盖该螺旋卷绕导体。
12.根据权利要求9所述的医疗设备导线，其特征在于，蚀刻该螺旋卷绕导体的表面，以促进与聚合物外皮粘合。
13.根据权利要求9所述的医疗设备导线，其特征在于，聚合物外皮由选自聚四氟乙烯(PTFE)、乙烯/四氟乙烯共聚物(ETFE)、氟化乙烯丙烯(FEP)、硅酮、聚氨酯、硅酮一聚氨酯共聚物和多孔聚合物所构成的组中的一种或几种材料组成。
14.根据权利要求9所述的医疗设备导线，其特征在于，聚合物外皮由选自多孔聚四氟乙烯(ePTFE)和叠层多孔聚四氟乙烯所构成的组中的一种或几种材料组成。
15.根据权利要求9所述的医疗设备导线，其特征在于，丝径小于0.127毫米，外径小于0.889毫米。
16.一种用于医疗设备的导体组件，其特征在于，导体组件包括：
一个螺旋卷绕导体，该螺旋卷绕导体具有一段长度且包括围绕导体的纵轴螺旋缠卷的多个匝，该螺旋卷绕导体具有圈节距和外径，该螺旋卷绕导体由具有丝径的一根细丝组成，其中圈节距为丝径的一至二倍，外径至少是圈节距的4.5倍，以便存在MRI场时该螺旋卷绕导体的发热最小；和
聚合物外皮，形成在该螺旋卷绕导体上且沿着该螺旋卷绕导体的该段长度，使单细丝螺旋卷绕导体的圈节距得以沿着该段长度保持，其中该聚合物外皮被设置成以增加螺旋卷绕导体的力矩传送容量。
17.根据权利要求16所述的导体组件，其特征在于，沿聚合物外皮的一段长度以一种图案切除该聚合物外皮，以在各部分切除处增加导体组件的柔韧性。
18.根据权利要求16所述的导体组件，其特征在于，以促进聚合物外皮与该螺旋卷绕导体之间粘合的材料覆盖该螺旋卷绕导体。
19.根据权利要求16所述的导体组件，其特征在于，蚀刻该螺旋卷绕导体的表面，以促进与聚合物外皮粘合。
20.根据权利要求16所述的导体组件，其特征在于，聚合物外皮由选自聚四氟乙烯(PTFE)、乙烯/四氟乙烯共聚物(ETFE)、氟化乙烯丙烯(FEP)、硅酮、聚氨酯、硅酮-聚氨酯共聚物和多孔聚合物所构成的组中的一种或几种材料组成。
21.根据权利要求16所述的导体组件，其特征在于，聚合物外皮由选自多孔聚四氟乙烯(ePTFE)和叠层多孔聚四氟乙烯所构成的组中的一种或几种材料组成。
22.根据权利要求16所述的导体组件，其特征在于，丝径小于0.127毫米，外径小于0.889毫米。
CN201080027308.5A 2009-06-26 2010-05-05 具有改善的力矩传送容量且减少mri发热的带有单细丝线圈的医疗设备导线 Expired - Fee Related CN102802723B (zh)

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