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CN105899157A - 抗撕裂柔性电路组件 - Google Patents

抗撕裂柔性电路组件 Download PDF

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CN105899157A
CN105899157A CN201580003853.3A CN201580003853A CN105899157A CN 105899157 A CN105899157 A CN 105899157A CN 201580003853 A CN201580003853 A CN 201580003853A CN 105899157 A CN105899157 A CN 105899157A
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flexible circuit
electrode
instruments
medical apparatus
polymeric material
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卡斯·A·汉森
德里克·C·苏特米斯特
蒂莫西·A·奥斯特鲁特
罗伯特·N·斯夸尔
詹姆士·M·安德森
马丁·R·威拉德
帕特里克·A·哈夫科斯特
吉安·韦伯
杰弗瑞·S·林德奎斯特
丹尼尔·J·霍恩
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Boston Scientific Scimed Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • 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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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation

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Abstract

一种用于交感神经消融的医疗器械可以包括，导管杆、设置在导管杆上或者联接至导管杆的可扩张构件，以及多个细长电极组件，每个电极组件被构造成具有多层的柔性电路。可扩张构件可以被配置成在未扩张形态与扩张形态之间转换。多个电极组件可以设置在可扩张构件的外表面上。多个电极组件中的每一个可以包括增强抗撕性，例如通过电极组件一个以上的层包含加强结构。

Description

抗撕裂柔性电路组件
相关申请的交叉引用
本申请根据《美国法典》35章§119要求于2014年1月6日提交的美国临时申请序列号第61/924,113的优先权，其整个内容以引用方式并入本文。
技术领域
本发明涉及医疗器械以及制造医疗器械的方法。尤其，本发明涉及包括了抗撕裂性能增强的消融电极的柔性电路。
背景技术
各种用于医疗的，例如血管内使用的体内医疗器械已经被开发。一种这样的医疗器械为配置用于组织消融，例如交感神经消融的消融导管。所述医疗器械可以包括一个以上安装在可充胀球囊被构造成柔性电路的电极组件。在一些例子中，已经观察到当朝近侧缩回消融导管进入到引导导管时，柔性电路可能勾住消融导管定位所通过的引导导管的边缘。
因此，需要提供一种电极组件，其形成为柔性电路，所述柔性电路包括这样的结构特征，当被缩回，例如进入到引导导管时，如果发生电极组件勾住引导导管(或者其他装置)的端部，可以减少撕裂的可能性。
发明内容
本发明涉及几种可供选择的制造医疗器械结构和组件的设计、材料和方法，以及它们的用途。
因此，一个说明性实施例为一种用于交感神经消融的医疗器械。所述医疗器械包括导管杆，所述导管杆具有纵轴，以及可膨胀球囊，所述可膨胀球囊设置在所述导管杆上。所述球囊能够在未扩张形态与扩张形态之间转换。所述医疗器械进一步包括细长电极组件，所述电极组件被构造成具有多层的柔性电路。所述电极组件被安装在所述球囊的外表面上。所述柔性电路所述多层中的第一层具有根据ASTM D-1004-09大于7.5N(1.7lbf)的初始撕裂强度。在一些例子中，所述第一层可以具有根据ASTM D-1922-09大于0.15N(0.03lbf)的撕裂扩展强度。
另一个说明性实施例为一种用于交感神经消融的医疗器械。所述医疗器械包括导管杆，所述导管杆具有纵轴，以及可扩张构件，所述可扩张构件联接至所述导管杆。所述可扩张构件能够在未扩张形态与扩张形态之间转换。所述医疗器械进一步包括细长电极组件，所述电极组件被构造成安装在所述可扩张构件外表面上的柔性电路。所述柔性电路包括多条传导迹线，所述传导迹线插入在由增强聚合物材料形成的第一绝缘层和由聚合物材料形成的第二绝缘层之间。
另一个说明性实施例为一种形成用于组织消融的医疗器械的方法。所述方法包括提供一种电极组件，所述电极组件被构造成具有多根被插入在由增强聚合物材料形成的第一绝缘层和由聚合物材料形成的第二绝缘层之间的传导迹线的柔性电路。所形成的柔性电路接着被安装到球囊导管可充胀球囊的外表面上。
上面有关一些实施例的概述并不旨在描述本发明每个公开的实施例或每个实施方式。更特别地，下面的附图及具体实施方式举例说明了这些实施例。
附图说明
结合附图考虑以下的具体实施方式可更完整地理解本发明，其中：
图1为示范交感神经消融装置的示意图；
图2为交感神经消融装置的示范可扩张构件的立体图；
图3为图2所示的可扩张构件在展开或平坦形态下的局部俯视图；
图4为示例性电极组件的一部分的仰视图；
图5为沿图4线5-5截取的图4示例性电极组件的剖视图；
图6为图4示例性电极组件的分解图；
图7为安装在可扩张构件上示例性电极组件加强层的示意图；
图8A为安装在可扩张构件上示例性电极组件另一种加强层的示意图；
图8B为安装在可扩张构件上示例性电极组件另一种加强层的示意图；
图9为安装在可扩张构件上示例性电极组件另一种加强层的示意图；
图10为安装在可扩张构件上示例性电极组件另一种加强层的示意图；
图11为包括加强层的示例性电极组件的剖视图。
虽然本发明可作出各种改型和替代形式，但其细节已经由附图中的实例示出，并会详细描述。然而，应理解，本发明并不旨在将本发明限制为所述的特定实施例。相反，本发明涵盖了落在本发明实质和范围内的所有改型、等同物和替代形式。
具体实施方式
以下说明应当参照附图来阅读，附图不必是成比例的，其中在全部附图中，相同的附图标记表示相同的元件。具体实施方式和附图旨在说明，而非限制请求保护的本发明。本领域技术人员应当意识到，在不脱离本发明范围的情况下，描述和/或示出的各种元件可以以各种组合和形态布置。具体实施方式和附图说明了请求保护的本发明的示范实施例。
就以下定义的术语而言，这些定义应当适用，除非在权利要求或本说明书的其他地方给出了不同的定义。
无论是否明确示出，本文中假定所有的数值由术语“约”进行修饰。在数值情况下，术语“约”通常是指本领域技术人员会认为是与所引用的数值等同(即，具有相同的功能或结果)的数值范围。在许多情况下，术语“约”可包括四舍五入至最接近有效数字的数值。可假定术语“约”的其他使用(即，在除了数值的情况下)具有它们常规且习惯的定义，如根据本说明书的上下文所理解的并与其保持一致，除非另有说明。
由端点公开的数值范围包括在该范围内的所有数值(例如，1至5包括1、1.5、2、2.75、3、3.80、4和5)。
如在本说明书和所附权利要求中所使用的，单数形式“一”及“该”包括复数指代，除非文中清楚地另外指出。如在本说明书和所附权利要求中所使用的，术语“或”通常使用其包括“和/或”的含义，除非文中清楚地另外指出。
应当注意，在本说明书中提及“一实施例”、“一些实施例”、“其他实施例”等表明所描述的实施例可包括特定的特征、结构或特性，但未必每个实施例都包括该特定的特征、结构或特性。此外，这种短语未必是指相同的实施例。而且，当结合一实施例描述特定的特征、结构或特性时，无论是否明确示出，结合其他实施例实现这种特征、结构或特性在本领域技术人员的认知范围内，除非清楚地表明相反。即，以下描述的各种个别元件，即使没有以特定的组合明确示出，虽然如此可考虑相互结合或布置以形成其他附加的实施例或完整和/或充实描述的实施例，如本领域技术人员所理解的。
某些治疗旨在暂时或永久中断或者改变选择的神经功能。在一些实施例中，神经可以是交感神经。一个示范治疗是肾神经消融，其有时用来治疗诸如或与高血压、充血性心力衰竭、糖尿病有关的状况，或其他受高血压或盐滞留影响的状况。肾脏产生交感神经响应，其可增加水和/或钠不期望的滞留。例如，交感神经响应的结果可增加血压。对一些延伸到肾脏(例如，邻近肾动脉或者以其他方式沿着肾动脉)的神经进行消融可减少或消除这种交感神经响应，这可促进相关联的不期望的症状相应减轻(例如，血压降低)。
本发明的一些实施例涉及能量产生及控制装置，其通常用于靶组织的治疗以实现治疗效果。在一些实施例中，靶组织是包含神经或接近神经的组织。在其他实施例中，靶组织是交感神经，包括例如邻近血管的交感神经。在其他实施例中，靶组织是腔组织，其可进一步包括诸如在动脉疾病中发现的病变组织。
在本发明的一些实施例中，按目标剂量传送能量的能力可用于神经组织以实现有益的生物响应。例如，已知慢性疼痛、泌尿障碍、高血压、以及各种其他的持续性状况通过神经组织手术而受到影响。例如，已知，可能不对药物响应的慢性高血压可通过使接近肾动脉的过多神经活动失效而得到改善或者根除。还知道，神经组织生来不具有再生特性。因此，通过破坏神经组织的传导路径能够有益地影响过多的神经活动。破坏神经传导路径时，避免对周围神经或器官组织造成损伤是特别有利的。指引并控制能量剂量的能力非常适合于神经组织的治疗。无论是以加热能量剂量或是消融能量剂量，如本文中描述并披露的能量传送的精确控制可指向神经组织。此外，能量的定向应用可足以瞄准神经，而无需准确接触，如使用典型的消融探针时所需要的。例如，可以以很高的、足以使神经组织变性的温度施加离心(eccentric)加热，而不会导致消融，并且无需刺穿腔组织。然而，可能还期望将本发明的能量传送表面配置为刺穿组织并类似于具有准确能量剂量的消融探针那样传送消融能量，能量剂量由能量控制和产生装置控制。
在一些实施例中，去神经治疗的疗效可通过治疗前，治疗中，和/或治疗后测量来评估以对特定患者定制一个以上治疗参数或者识别是否需要附加治疗。例如，去神经系统可包括用于评估治疗是否已经导致或者正在导致靶组织或邻近组织中神经活动的减少，这可为调节治疗参数提供反馈或者表明附加治疗的必要性。
本文描述的许多装置和方法是关于肾神经消融和/或调制进行讨论的。然而，可以考虑，该装置和方法可用于期望进行交感神经调制和/或其他组织调制的其他治疗位置和/或应用，包括加热、激活、阻断、破坏或消融，诸如但不限于：血管、泌尿管、或经由套针和插管进入的其他组织中。例如，本文描述的装置和方法可用于增生组织消融、心脏消融、疼痛管理、肺静脉隔离、肺静脉消融、肿瘤消融、良性前列腺增生治疗、神经激发或阻断或消融、肌肉活动调制、组织热疗或其他加热等。公开的方法和装置可适用于任何相关的医疗程序，包括人类和非人类对象。术语调制是指消融和可改变受影响的神经和其他组织的功能的其他技术。
图1为示范交感神经消融系统100的示意图。系统100可包括交感神经消融装置120。交感神经消融装置120可用来消融邻近肾脏K的神经(例如，肾神经，例如，肾动脉RA周围的肾神经)。在使用过程中，交感神经消融装置120可前进通过诸如主动脉A的血管至肾动脉RA内的位置。这可包括使交感神经消融装置120前进通过引导鞘套或导管14。当根据需要定位好时，交感神经消融装置120可被激活以激活一个以上电极(未示出)。这可包括将交感神经消融装置120可操作地联接至控制单元110，其可包括RF发生器，以便供给期望的激活能量至电极。例如，交感神经消融装置120可包括具有第一连接器20的线缆或传导构件18，第一连接器20可连接至控制单元110上的第二连接器22和/或联接至控制单元110的线缆24。在至少一些实施例中，控制单元110也可用来供给/接收适当的电能和/或信号以激活一个以上设置在交感神经消融装置120的远端或远端附近的传感器。当适当激活时，一个以上电极可如下所述地消融组织(例如，交感神经)，一个以上传感器可用来检测期望的物理和/或生物参数。
在一些实施例中，交感神经消融装置120可包括细长管状构件或导管杆122，如图2所示。在一些实施例中，细长管状构件或导管杆122可配置成在导丝或其他细长医疗器械上滑动前进至靶部位。在一些实施例中，细长管状构件或导管杆122可配置成在引导鞘套或导管14内滑动前进至靶部位。在一些实施例中，细长管状构件或导管杆122可配置成在导丝上、引导鞘套或导管14内或其组合前进至靶部位。可扩张构件130可设置在细长管状构件或导管杆122的远侧区域处、远侧区域上、远侧区域周围或附近。在一些实施例中，可扩张构件130可以是顺应性或非顺应性球囊。在一些实施例中，可扩张构件130可在未扩张形态与扩张形态之间转换。
例如，如图2所示，在一些实施例中，根据多个大体筒状的治疗区A-D，一个以上电极组件可布置在显示为扩张状态的可扩张构件130上。在其他实施例中，可扩张构件130或治疗系统的其他部件可包括不在治疗区中的或另外未使用的或未配置成输送治疗能量的附加电极组件。
治疗区A-D和相关联的电极组件140a-d进一步在图3中示出，其为图2所示的可扩张构件130的一部分的“展开”描绘。治疗区A-D可沿纵轴线L-L彼此纵向相邻，并可配置成使由电极组件施加能量产生可能重叠或可能不重叠的治疗。由纵向相邻的双极电极组件140a-d所施加的治疗可以沿纵轴线L-L周向非连续。例如，参照图3，在治疗区A中所产生的损伤在一些实施例中与在治疗区B中所产生的损伤绕周界(在该视图中关于L-L为横向)重叠最小化。然而，在其他实施例中，由电极组件(如图3中所示的电极组件)所施加的能量可纵向、周向和/或以其他方式至少在一定程度上重叠。每个电极片组件可包括四个元件，其为远侧电极片150a-d、中间辫160a-d、近侧电极片170a-d和近侧辫180b、d(未示出电极片组件140a和140c的近侧辫)。
图4-6中示出了示范电极组件。图4示出所述示范电极组件200的仰视图或电极组件200的底侧视图，该底侧可能面向，可能接触和/或可能直接附接和/或结合至可扩张构件130的外表面。电极组件200可构造为具有多层的柔性电路。这种层可以是连续的或不连续的(即，由离散部分组成)。如图5中的截面所示，绝缘的基层202可为电极组件200提供基座。基层202可由诸如聚酰亚胺的聚合物构造而成，尽管也可考虑其他材料。在一些实施例中，基层202可以是约0.010mm至约0.020mm厚。在一些实施例中，基层202可以是约0.015mm厚。也可考虑其他合适的厚度。供参考，基层202可形成电极组件200的底侧，该底侧可能面向，可能接触和/或可能直接附接和/或结合至可扩张构件130的外表面。图5为沿图4线5-5截取的剖视图，其中电极组件200的底侧面向可扩张构件130的外表面，并且附接和/或结合到其。图6为图4中所示电极组件200的分解视图，进一步示出了电极组件200的各层。
传导层204可包括在基层202的顶部上层叠的多个离散传导迹线。在一些实施例中，多个离散传导迹线可通过非传导材料(例如绝缘层206的部分)横向隔开。传导层204的多个离散传导迹线可包括，例如，电沉积铜或冷轧退火铜的层。也可考虑其他合适的传导材料(例如石墨烯和其他其它碳基材料)。在一些实施例中，传导层204和/或多个离散传导迹线可以是约0.010mm至约0.030mm厚。在一些实施例中，传导层204和/或多个离散传导迹线可以是约0.018mm厚。也可考虑其他合适的厚度。
绝缘层206可以离散地或连续地层叠在传导层204的顶部，使得传导层204可流体密封在基层202与绝缘层206之间。换句话说，绝缘层206可形成电极组件200的顶侧或表面，其可能背向可扩张构件130的外表面。基层202、传导层204与绝缘层206之间的关系是说明性的，可考虑其他构造。像基层202一样，绝缘层206可由诸如聚酰亚胺的聚合物构造而成，尽管也可考虑其他材料。在一些实施例中，绝缘层206可以约0.010mm至约0.020mm厚。在一些实施例中，绝缘层206可以约0.013mm厚。也可考虑其他合适的厚度。在一些实施例中，绝缘层206可以是完整或部分的聚合物涂层，如PTFE或硅酮。也可考虑其他材料。
在一些实施例中，多层(即，基层202、传导层204和绝缘层206)可结合以界定柔性电路的厚度。在一些实施例中，柔性电路的厚度可沿柔性电路和/或电极组件200的长度大致恒定。在一些实施例中，柔性电路的厚度可以是约0.046mm。
图4中示出的电极组件200可包括远侧电极片208。在这个区域，基层202可形成矩形。这并不旨在限制。可考虑其他形状。如图所示，电极组件200可包括多个延伸通过其的开口以提供增加的柔性，片和组件的其他部分可包括圆的或弯曲的角、过渡部和其他部分。在一些情况下，开口和圆的/弯曲的特征可增强组件对从可扩张构件130分层的抵抗，如一些情况下可扩张构件130反复扩张和塌缩(这也是从保护鞘套进行布置和取回至保护鞘套所必需的)时可能发生的，诸如在程序过程中治疗多个部位时可能需要的。
如上面所讨论的，远侧电极片208可包括多个层叠在基层202的顶部上的离散传导迹线。多个离散传导迹线可包括接地电极迹线210、有源电极迹线212和传感器迹线214。接地电极迹线210可包括横向偏离传感器接地片218的细长接地电极支撑件216。传感器接地片218可电联接至接地电极迹线210的细长接地电极支撑件216并可位于远侧电极片208的中心处。桥接部220可将传感器接地片218的最远侧部分连接至接地电极迹线210的细长接地电极支撑件216的远侧部分。随着桥接部220行进至传感器接地片218，桥接部220的宽度逐渐减小。在一些实施例中，桥接部220可具有相对一致且细的宽度以获得期望的柔性量。细长接地电极支撑件216在其近端处可宽度逐渐减小，然而，这不是必需的。在一些实施例中，细长接地电极支撑件216在其近侧部分可突然过渡至薄得多的迹线以获得期望的柔性量。有源电极迹线212可包括横向偏离细长接地电极支撑件216、传感器接地片218和/或传感器功率片224的细长有源电极支撑件217。传感器功率片224可电联接至传感器迹线214并可位于远侧电极片208的中心处。细长有源电极支撑件217在其近端处可宽度逐渐减小，然而，这不是必需的。在一些实施例中，细长有源电极支撑件217在其近侧部分可突然过渡至薄得多的迹线以实现期望的柔性量。通常，可对具有缩颈的迹线的曲率进行优化以降低球囊的再捕获力并降低任何剐破(可能存在锐利的轮廓)的可能性。也可对迹线的形状和位置进行优化以提供电极组件200作为一整体的尺寸稳定性，从而防止在布置和使用期间扭曲变形。
如图4所示，接地电极迹线210和有源电极迹线212可各自包括多个电极222。在一些实施例中，可为每个电极迹线设置至少一个电极，然而，也可使用更多或更少的电极。例如，在一些实施例中，可为每个电极迹线设置三个电极。多个电极222可在绝缘层206上突出和/或延伸通过绝缘层206。在一些实施例中，多个电极222可包括至少一个有源电极和至少一个接地电极，其分别附接和/或电连接至细长有源电极支撑件217和细长接地电极支撑件216。在一些实施例中，多个电极222可附接和/或电连接至细长接地电极支撑件216从而界定多个接地电极，和/或附接和/或电连接至细长有源电极支撑件217从而界定多个有源电极。在一些实施例中，开口或空腔可以穿过绝缘层206向下到达细长接地电极支撑件216和/或细长有源电极支撑件217形成(例如，激光烧蚀)，以暴露部分的接地电极支撑件216和/或细长有源电极支撑件217，接着例如金的导电物质可以电镀到所形成的开口或空腔中以形成电极222。
在一些实施例中，多个电极222可以是约0.030mm至约0.070mm厚。在一些实施例中，多个电极222可以是约0.051mm厚。在一些实施例中，多个电极222可在绝缘层206上延伸约0.020mm至约0.050mm。在一些实施例中，多个电极222可在绝缘层206上延伸约0.038mm。此外，每个电极可具有倒圆角以降低产生抓点剐住其他装置和/或组织的倾向。尽管已在双极电极组件的情况下描述了多个电极和与其相关联的迹线的上述说明，本领域技术人员应认识到相同的电极组件也可在单极模式下运行。例如，作为一个非限制性实例，与有源电极迹线212和242相关联的多个电极可用作单极电极，其中接地电极迹线210在那些电极的通电期间是断开的。
传感器迹线214可位于远侧电极片208的中心处并可包括面向和/或邻近传感器接地片218的传感器功率片224。这些片可连接至温度传感器226(如热敏电阻)的功率和接地极。在一些实施例中，温度传感器226在近侧可连接至传感器功率片224并可在远侧连接至传感器接地片218。在一些实施例中，温度传感器226可与传感器功率片224和/或传感器接地片218直接接触。在一些实施例中，温度传感器226可通过钎焊、焊接等或其他适合的方式附接和/或电连接至传感器功率片224和/或传感器接地片218。在一些实施例中，温度传感器226可设置或定位于至少一个有源电极与至少一个接地电极之间。在一些实施例中，温度传感器226可设置或定位于多个有源电极与多个接地电极之间。
在一些实施例中，温度传感器226可具有约0.500mm至约2.000mm的长度，以及约0.200mm至约0.800mm的宽度。在一些实施例中，温度传感器226可具有约1.000mm的长度以及约0.500mm的宽度。为了帮助减少总厚度，温度传感器226可定位在基层202的开口内。在一些实施例中，温度传感器226可从基层202向外突出约0.050mm至约0.200mm。在一些实施例中，温度传感器226可具有约0.115mm的厚度，并可从基层202向外突出约0.100mm。在一些实施例中，在温度传感器226处的电极组件200(即，包括多个层和温度传感器226)的总厚度可以是约0.146mm。在一些实施例中，温度传感器226可超过在温度传感器226处的电极组件200的总厚度的65％。
在一些实施例中，电极组件200(包括多个层、温度传感器226和多个电极222)的最大厚度可以是约0.150mm至约0.200mm。在一些实施例中，电极组件200的最大厚度可以是约0.184mm。在一些实施例中，温度传感器226可超过电极组件200的最大厚度的50％。
在一些实施例中，温度传感器226可以是热敏电阻。如所示，温度传感器226可设置在远侧电极片208和/或电极组件200的非组织接触侧(即，底侧)上。于是，当温度传感器226整合到消融装置120时，温度传感器226可俘获在电极组件200和可扩张构件130之间。这可能是有利的，因为表面安装的电气部件(如热敏电阻)可能通常具有尖锐的边缘和角，其可钩住组织并能在球囊展开和/或收缩中引发问题。这种布置还可使钎焊接头免于接触血液，因为焊料通常是非生物相容的。进一步地，由于在接触细长有源电极支撑件217的多个有源电极与接触细长接地电极支撑件216的多个接地电极之间布置有温度传感器226，温度传感器226可测量代表多个电极222和/或邻近和/或接触多个电极222的组织的温度。
在其他的实施例中，温度传感器226可以是热电偶，例如代理人案号为1001.3460100，题为“EMBEDDED THERMOCOUPLE IN DENERVATION FLEX CIRCUIT”，于2013年10月25日提出的，编号为61/895,788的美国临时申请中所公开的，其全部通过引用并入文中。例如，传感器迹线214可以位于远侧电极片208的中心处，并且可以电连接到传感器接地片218以形成温度传感器226，例如热电偶(例如，T型配置：铜/康铜)。正如现有技术中已知的，热电偶可以在两种不同金属的连接处基于连接处的温度产生电压差。在这种实施例中，等温结可以形成在电极组件200的近端，与电极片和/或多个电极间隔开且热隔离。如上面所讨论的，传感器接地片218可以形成为传导层204内电沉积铜的离散迹线。在这种实施例中，传感器迹线214的远端部分，以及一些情况下的整个传感器迹线214可以由例如康铜(例如，白铜)、镍铬或者其他合适的传导材料形成。温度传感器226可以由与传感器接地片218重叠的传感器迹线214的远端部分形成，使得传感器迹线214与传感器接地片218直接接触。在一些例子中，可以通过将传感器迹线214的远端部分溅射在传感器接地片218上，从而形成溅射热电偶，或者其他合适的手段来形成温度传感器226。
在这种实施例中，温度传感器226可以被嵌入在基层202和绝缘层206之间，使得温度传感器226被流体密封在柔性电路和/或电极组件200内。换句话说，在一些实施例中，温度传感器226不可以定位在电极组件200的外表面上，但是图4-6中示出的温度传感器226(热敏电阻)可以定位在电极组件200的外表面上或者从其向外延伸。在一些实施例中，在温度传感器226处，在电极组件200的底侧可以没有突出形成。例如，在被弄平的形态下，面向可扩张构件130外表面的电极组件200的底侧，可以形成不间断的表面。在一些实施例中，在被弄平的形态下，电极组件的底侧可以包括(并且/或者不间断的表面可以形成)基本连续的平面，所述平面具有安放在电极组件200上/中的温度传感器226。换句话说，温度传感器226可以不通过或从基层202向外突出或延伸。
从远侧电极片208向近侧移动，结合的基层202、传导层204和绝缘层206可减小横向宽度至中间辫228。这里，如图4所示，传导层204可形成为包括中间接地线230、中间有源电极线232和中间传感器线234，它们可分别为远侧电极片208的接地电极迹线210、有源电极迹线212和传感器迹线214共同延伸的迹线。
从中间辫228向近侧继续移动，结合的基层202、传导层204和绝缘层206可增加横向宽度以形成近侧电极片236。近侧电极片236的构建可类似于远侧电极片208，其中电极的几何形状和温度传感器的布置基本相同，尽管也可存在各种差异。然而，如所示，近侧电极片236可关于沿中间接地线230延伸的中心纵轴线G-G横向偏离远侧电极片208。中间有源电极线232和中间传感器线234可沿各自关于中心轴线G-G平行的轴线与近侧电极片236共同横向延伸。
从近侧电极片236开始，结合的基层202、传导层204和绝缘层206可减小横向宽度以形成近侧辫238。近侧辫238可包括近侧接地线240、近侧有源电极线242和近侧传感器线244，以及中间有源电极线232和中间传感器线234。近侧辫238可包括连接器(未示出)使得能够联接至一个以上子线束和/或连接器并最终联接至控制单元110，例如通过线缆或传导构件18(图1中所示)。这些线中的每一个均可沿各自关于中心轴线G-G平行的轴线延伸。
如所示，电极组件200可具有远侧电极片208和近侧电极片236关于中心轴线G-G非对称的布局。进一步地，两个电极片的接地电极连同中间和近侧接地线230/240一起可沿中心轴线G-G大致对齐。已发现该布局可具有某些优点。例如，通过基本上共用相同的接地迹线，近侧辫的宽度可以仅为中间辫228宽度的约1.5倍，而不是在每个电极片具有独立的接地线的情况下的约两倍。因此，近侧辫238可以比并排定位的两个中间辫228更窄。
在一些实施例中，电极组件200可以是基本直线形的，可以沿可扩张构件130的整个长度或者与纵轴L-L成角度地沿可扩张构件130的整个长度延伸。在一些实施例中，电极组件可以在近侧区域平行于纵轴延伸，然后在远侧区域弯曲成角度定向(未示出)。
可能需要使用包括球囊的医疗器械，球囊具有联接至其上的一个以上电极组件，例如如上所述的。然而，在一些情况下，电极组件可包括相对刚性和/或体积大的材料或元件。于是，在治疗程序之后球囊收缩时，电极组件可能趋于平坦化和/或加宽。当如此配置时，一个以上电极组件和/或其组件或边缘在将医疗器械(例如，包括粘接的电极组件)向近侧缩回到引导导管中时可能钩住引导导管的边缘。本文所公开的医疗器械包括这样的结构特征，在医疗器械的电极组件或其他结构在缩回到例如引导导管中时，万一电极组件钩住引导导管(或其他装置)的端部，其可减小撕裂的可能性。
图7示出了电极组件200柔性电路加强层300的第一实施例，正如文中所描述的，电极组件200安装在可扩张构件130(例如，可充胀球囊)上。加强层300可以是电极组件200柔性电路多层中的一层。例如，加强层300可以是绝缘基层202、绝缘层206和/或柔性电路另外的层。
加强层300可以由具有定向或者双轴取向聚合物链310的聚合物材料形成。例如，聚合物材料可以具有大体垂直于可扩张构件130和导管杆122纵轴L定向的聚合物链310。这种聚合物链310的定向可以增加加强层300在平行于纵轴L方向上的抗撕裂力。加强层300的一些合适材料包括单轴或双轴取向聚酰胺(PI)或聚对苯二甲酸乙酯(PET)片材，但是如果需要，也可以使用其他聚合物材料。
在一些例子中，基层202和绝缘层206可以包括定向聚合物链310。在这些例子中，基层202的定向聚合物链310可以垂直于绝缘层206的定向聚合物链310设置。因此，电极组件200可以安装到可扩张构件130，其中基层202的定向聚合物链310大体垂直于纵轴L布置，或者电极组件200可以安装到可扩张构件130，其中绝缘层206的定向聚合物链310通常垂直于纵轴L布置。
在其他的例子中，基层202和绝缘层206可以包括定向聚合物链310，其中基层202的定向聚合物链310平行于绝缘层206的定向聚合物链310布置。因此，电极组件200可以安装到可扩张构件130，其中，定向聚合物链310大体垂直于纵轴L布置。
图8A和8B示出了电极组件200柔性电路加强层400的另外的实施例，正如文中所描述的，电极组件200安装在可扩张构件130(例如，可充胀球囊)上。加强层400可以是电极组件200柔性电路多层中的一层。例如，加强层400可以是绝缘基层202、绝缘层206和/或柔性电路另外的层。
加强层400可以由其中嵌入了一根以上或者多根增强纤维410的聚合物材料形成。例如，在一些例子中，增强纤维410可以是超高分子量聚乙烯(UHMWPE)纤维(例如，)、纳米纤维、诸如双壁纳米管(DWNT)聚合物纤维、碳纳米管纤维、玻璃纤维、聚对苯对苯(例如，)丝线等。其他合适的材料包括诸如棉花、羊毛或者纤维素的天然材料。在一些实施例中，增强纤维410可以具有例如大约2-6微米或者大约3-4微米的长度。在一些例子中，增强纤维410可以是连续的纤维，例如在静电纺丝工艺中形成的纳米纤维。在一些例子中，加强层400可以包括使用静电纺丝工艺形成的一根连续纤维410或者多根连续纤维410，以在加强层400上附着连续的纳米纤维束。
增强纤维410可以如图8B中所示随机布置在加强层400的聚合物片材中，或者增强纤维410可以朝着所需的方向设置。例如，在一些例子中，增强纤维410可以如图8A中所示大体垂直于可扩张构件130和导管杆122纵轴L布置。
在一些例子中，加强层400可以由聚酰亚胺(PI)或聚对苯二甲酸乙酯(PET)片材形成，其中增强纤维410嵌入其中。
图9示出了电极组件200柔性电路加强层500的另一个实施例，正如文中所描述的，电极组件200安装在可扩张构件130(例如，可充胀球囊)上。加强层500可以是电极组件200柔性电路多层中的一层。例如，加强层500可以是绝缘基层202、绝缘层206和/或柔性电路另外的层。
加强层500可以由其中嵌入了增强纤维510的聚合物材料形成。例如，加强层500可以由聚酰亚胺(PI)或聚对苯二甲酸乙酯(PET)片材形成，其中增强纤维510嵌入其中。在图9的实施例中，增强纤维510表现为从加强层500的第一边到第二边穿过加强层500的整个宽度连续延伸。然而，在其他的例子中，增强纤维510可以穿过小于加强层500整个宽度的长度不连续地布置。
增强纤维510可以朝着所需的方向布置，或者增强纤维510可以随机布置在加强层500的聚合物片材中。例如，如图9中所示，增强纤维510大体可以垂直于可扩张构件130和导管杆122的纵轴L布置。
图10示出了电极组件200柔性电路加强层600的另一个实施例，正如文中所描述的，电极组件200安装在可扩张构件130(例如，可充胀球囊)上。加强层600可以是电极组件200柔性电路多层中的一层。例如，加强层600可以是绝缘基层202、绝缘层206和/或柔性电路另外的层。
加强层600可以由其中嵌入了增强纤维610的聚合物材料形成。例如，加强层600可以由聚酰亚胺(PI)或聚对苯二甲酸乙酯(PET)片材形成，其中增强纤维610嵌入其中。增强纤维610可以具有从增强纤维610的第一端到增强纤维610第二端逐渐减小的外直径。增强纤维610逐渐减小的外直径可以与聚合物片材建立机械锁，以防止增强纤维610被拉出加强层600的聚合物片材。
增强纤维610可以朝着所需的方向布置，或者增强纤维610可以随机布置在加强层600的聚合物片材中。例如，如图10中所示，增强纤维610大体可以垂直于可扩张构件130和导管杆122的纵轴L布置，其中交替由大到小、由小到大的外直径。
图11示出了电极组件200柔性电路加强层700的另一个实施例，正如文中所描述的，电极组件200安装在可扩张构件130(例如，可充胀球囊)上。加强层700可以是电极组件200柔性电路多层中的一层。例如，如图11中所示，加强层700可以插入在基层202和绝缘层206之间。然而，在其他的例子中，加强层700可以是绝缘基层202或者绝缘层206。
加强层700可以是超细纤维层，例如机织、针织、编织或者以其它方式形成的丝线网状物。在一些例子中，加强层700可以是形成为聚酰亚胺和/或聚对苯二甲酸乙酯(PET)纤维编织网状物的超细纤维层。其他合适的材料包括例如棉花、羊毛或者纤维素的天然材料。在一些例子中，加强层700可以包括形成为例如织物或者网状物的连续纤维，所述连续纤维例如在静电纺丝工艺中形成的纳米纤维。在一些例子中，加强层700可以是包括了使用静电纺丝工艺形成的一根连续纤维410或者多根连续纤维410的超细纤维网状物，以在加强层700上附着连续的纳米纤维束。
如图11中所示，在一些例子中加强层700(例如超细纤维层)可以包括第一开口，使得第一电极222可以延伸穿过第一开口与柔性电路的第一传导迹线(例如，接地电极迹线210的电极支撑件216)电接触，并且加强层700(例如超细纤维层)可以包括第二开口，使得第二电极222可以延伸穿过第二开口与柔性电路的第二传导迹线(例如，有源电极迹线212的细长有源电极支撑件217)电接触。加强层700可以包括为电极组件200柔性电路每个附加电极222准备的附加开口。
在其他的实施例中，加强层700可以定位在接地电极迹线210电极支撑件216、有源电极迹线212的细长有源电极支撑件217、和柔性电路传感器接地片218的另一侧。因此，加强层700可以定位在电极迹线和绝缘层202之间。因此，加强层700可以包括开口以允许温度传感器226穿过加强层700电接触传感器接地片218。
在一些例子中，加强层700中的开口可以在被应用到柔性电路之前预先形成在加强层700中。在其他的例子中，开口可以在柔性电路的制造过程中，在例如激光烧蚀工艺过程中穿过加强层700切割。
在其他的例子中，基层202、绝缘层206和/或附加层可以是热塑性聚酰胺，例如在一些例子中，所述热塑性聚酰胺可以是玻璃纤维增强聚酰胺。
根据本发明，所包含的加强结构，具有一层以上的电极组件200，可以提供具有增强抗撕性的电极组件200。例如，柔性电路的加强层可以具有根据ASTM D-1004-09大于7.5N(1.7lbf)的初始撕裂强度，以及根据ASTM D-1922-09大于0.15N(0.03lbf)的撕裂扩展强度。在一些例子中，加强层的初始撕裂强度可以根据ASTM D-1004-09大于8.0N(1.8lbf)，并且/或者撕裂扩展强度可以根据ASTM D-1922-09大于0.2N(0.045lbf)。
在使用中，消融装置120可前进通过血管或身体通道至邻近靶组织的位置处(例如，肾动脉内)，在一些情况下，这是在递送鞘套或导管14的帮助下进行的。在一些实施例中，靶组织可以是血管周围的一个以上交感神经。在一些实施例中，控制单元110可操作地联接至消融装置120，其可插入到血管或身体通道中使得可扩张构件130(具有多个电极组件200)可邻近需要治疗的靶组织放置。放置消融装置120邻近需要治疗的靶组织可根据常规方法(例如，在荧光镜引导下沿导丝)进行。当合适地进行定位时，可扩张构件130可从塌缩递送形态扩张至扩张形态，例如在使用球囊的情况下通过对流体加压约2-10atm。这可使多个电极靠着血管壁放置/促使多个电极靠着血管壁。多个有源电极可被激活。消融能量可从多个有源电极开始输送，通过靶组织(在这里交感神经可被消融、调制或以其他方式受到影响)返回至多个接地电极(在双极配置下)，或者返回共用的接地电极(在单极配置下)。治疗后，可扩张构件130可塌缩至塌缩递送形态从而缩回到引导鞘套或导管14中，随后从血管或身体通道中取出。
可用于消融装置120(和/或本文公开的其他装置)的各种组件的材料可包括通常与医疗器械相关的那些。为了简单起见，下面的讨论参照消融装置120。然而，这并不旨在限制本文所述的装置和方法，因为讨论可适用于其他类似的管状构件和/或可扩张构件和/或本文所公开的管状构件和/或可扩张构件的组件。
消融装置120及其各种组件可由金属，金属合金，聚合物(下文公开了其一些示例)，金属-聚合物复合物，陶瓷，及其组合等，或者其他合适的材料。合适的聚合物的一些示例可包括聚四氟乙烯(PTFE)，乙烯-四氟乙烯(ETFE)，氟化乙烯丙烯(FEP)，聚氧甲烯(POM，例如，杜邦公司出售的)，聚醚嵌段酯，聚氨酯(例如，聚氨酯85A)，聚丙烯(PP)，聚氯乙烯(PVC)，聚醚酯(例如，DSM工程塑料公司出售的)，醚基或酯基共聚物(例如，丁烯/聚(亚烃基醚)邻苯二甲酸酯和/或诸如杜邦公司出售的的聚酯弹性体)，聚酰胺(例如，拜尔公司出售的或埃尔夫阿托公司出售的)，弹性体聚酰胺，嵌段聚酰胺/醚，聚醚嵌段酰胺(PEBA，例如以为商标名出售的产品)，乙烯-乙酸乙烯酯共聚物(EVA)，硅树脂，聚乙烯(PE)，马勒克斯高密度聚乙烯，马勒克斯低密度聚乙烯，线性低密度聚乙烯(例如，)，聚酯，聚对苯二甲酸丁二醇酯(PBT)，聚对苯二甲酸乙二醇酯(PET)，聚对苯二甲酸丙二醇酯(polytrimethyleneterephthalate)，聚萘二甲酸乙二醇酯(PEN)，聚醚醚酮(PEEK)，聚酰亚胺(PI)，聚醚酰亚胺(PEI)，聚苯硫醚(PPS)，聚苯醚(PPO)，聚对苯二甲酰对苯二胺(例如，)，聚砜，尼龙，尼龙-12(诸如EMS American Grilon公司出售的)，全氟(丙基乙烯基醚)(PFA)，乙烯基乙烯醇，聚烯烃，聚苯乙烯，环氧树脂，聚偏二氯乙烯(PVdC)，聚(苯乙烯-b-异丁烯-b-苯乙烯)(例如，SIBS及/或SIBS 50A)，聚碳酸脂，离聚物，生物相容聚合物，其他适材料，或者前述材料的混合物，组合物，共聚物，聚合物/金属组合物，等等。在一些实施方式中，鞘套可与液晶聚合物(LCP)混合。例如，混合物可包含高达大约6％的LCP。
合适的金属和金属合金的一些示例包括诸如304V，304L，和316LV不锈钢的不锈钢；软钢；诸如线弹性和/或超弹性镍钛诺的镍-钛合金；诸如镍-铬-钼合金(例如，诸如625的UNS:N06625，诸如的UNS:N06022，诸如的UNS:N10276，其他合金等)的其他镍合金，镍-铜合金(例如，诸如400，400，400等的UNS:N04400)，镍-钴-铬-钼合金(例如，诸如等的UNS:R30035)，镍-钼合金(例如，诸如ALLOY的UNS:N10665)，其他镍-铬合金，其他镍-钼合金，其他镍-钴合金，其他镍-铁合金，其他镍-铜合金，其他镍-钨合金或钨合金等；钴-铬合金；钴-铬-钼合金(例如，诸如等的UNS:R30003)；铂富集不锈钢；钛；及其组合等；或者任何其他合适的材料。
如本文提到的，在市售镍-钛或镍钛诺合金的家族里，有称作“线弹性”或“非超弹性”的种类，尽管其在化学性质方面类似于常见的形状记忆和超弹性种类，但其可呈现出独特且有益的机械性能。线弹性和/或非超弹性镍钛诺与超弹性镍钛诺的区别可在于，线弹性和/或非超弹性镍钛诺在应力/应变曲线中不具有实质的“超弹性坪(superelasticplateau)”或“标志区域(flag region)”，而超弹性镍钛诺则具有。相反，在线弹性和/或非超弹性镍钛诺中，随着可恢复应变增大，应力以大致线性，或稍微线性，但不必完全线性的关系持续增大直至塑性变形开始或者至少以比超弹性镍钛诺所示的超弹性坪和/或标志区域更为线性的关系。这样，为了本公开的目的，线弹性和/或非超弹性镍钛诺也可称为“大致”线弹性和/或非超弹性镍钛诺。
在一些情况下，线弹性和/或非超弹性镍钛诺与超弹性镍钛诺的区别也可在于，线弹性和/或非超弹性镍钛诺可在保持大致弹性的同时承受多达大约2-5％的应变(例如，在塑性变形之前)，而超弹性镍钛诺在塑性变形之前可承受多达大约8％的应变。这两种材料都能够与诸如不锈钢的其他线弹性材料(其也能够根据组分而区别开)区别开，其他线弹性材料在塑性变形之前仅可承受大约0.2到0.44％的应变。
在一些实施方式中，线弹性和/或非超弹性镍-钛合金是不具有任何马氏体相变/奥氏体相变的合金，相变可通过差示扫描量热仪(DSC)和动态金属热分析(DMTA)在很大的温度范围内进行分析而检测得到。例如，在一些实施方式中，在大约-60摄氏度(℃)到大约120℃的范围内通过差示扫描量热仪(DSC)和动态金属热分析(DMTA)未测得线弹性和/或非超弹性镍-钛合金的马氏体相变/奥氏体相变。因此，在这个非常宽广的温度范围内，这种材料的机械弯曲性能通常不会受到温度的影响。在一些实施方式中，线弹性和/或非超弹性镍-钛合金在环境温度或室温下的机械弯曲性能与在体温下的机械性能基本相同，例如，都不显示超弹性坪和/或标志区域。换句话说，在宽广的温度范围内，线弹性和/或非超弹性镍-钛合金保持其线弹性和/或非超弹性特性和/或性能。
在一些实施方式中，线弹性和/或非超弹性镍-钛合金中镍的重量百分比可在大约50到大约60的范围内，其余部分基本为钛。在一些实施方式中，镍的重量百分比在大约54到大约57的范围内。合适的镍-钛合金的一个示例是日本神奈川县的Furukawa TechnoMaterial Co.销售的FHP-NT合金。在美国专利第5,238,004号和6,508,803号中公开了镍钛合金的一些示例，通过引用将其合并在此。其他合适的材料可包括ULTANIUMTM(可从Neo-Metrics公司购买)和GUM METALTM(可从丰田公司购买)。在一些其他的实施方式中，超弹性合金(例如超弹性镍钛诺)能够用来实现期望的性能。
在至少一些实施方式中，消融装置120的部分也可掺杂有，材料为，或包括不透射线的材料。不透射线的材料理解为能够在医疗过程中在荧光透视屏或其他成像技术上生成相对较亮图像的材料。这个相对较亮的图像可帮助消融装置120的使用者判定其位置。不透射线的材料的一些示例能够包括但不限于，金，铂，钯，钽，钨合金，装有不透射线填料的聚合物材料等。此外，其他不透射线的标记带和/或线圈也可包括在消融装置120的设计中以实现相同的结果。
在一些实施方式中，给予消融装置120一定程度的磁共振成像(MRI)兼容性。例如，装置的部分可由基本不使图像失真及不生成实质伪影(即，图像中的间隙)的材料制成。例如，某些铁磁材料可能不适合，因为它们会在MRI图像中生成伪影。在这些实施方式中的一些或其他实施方式中，消融装置120的部分也可由MRI机器能够成像的材料制成。显示出这些特性的一些材料包括，例如钨，钴-铬-钼合金(例如，诸如 等的UNS:R30003)，镍-钴-铬-钼合金(例如，诸如等的UNS:R30035)，镍钛诺等，以及其他材料。
2013年1月25日提交，名为《Methods and apparatuses for remodeling tissueof or adjacent to a body passage》的美国专利申请序列号13/750,879，现公布为美国专利公告第US20130165926A1号，通过引用并入本文。
应理解，本发明在许多方面仅是说明性的。在不超出本发明范围的前提下，可在细节上，特别是形状、大小和步骤安排上做出变化。这可包括在适当的程度上使用一个示范实施方式的任何特征用于其他实施方式中。当然，本发明的范围是以所附权利要求表述所用的语言进行限定。

Claims (15)

1.一种用于交感神经消融的医疗器械，包括：
导管杆，所述导管杆具有纵轴；
可膨胀球囊，所述可膨胀球囊设置在所述导管杆上，所述球囊能够在未扩张形态与扩张形态之间转换；以及
细长电极组件，所述电极组件被构造成具有多层的柔性电路，所述电极组件被安装在所述球囊的外表面上；
其中所述柔性电路所述多层中的第一层具有根据ASTM D-1004-09大于7.5N(1.7lbf)的初始撕裂强度。
2.如权利要求1所述的医疗器械，其中所述柔性电路所述多层中的第一层具有根据ASTM D-1922-09大于0.15N(0.03lbf)的撕裂扩展强度。
3.如权利要求1所述的医疗器械，其中所述柔性电路所述多层中的第一层具有根据ASTM D-1922-09大于0.2N(0.045lbf)的撕裂扩展强度。
4.如权利要求1、2或3所述的医疗器械，其中所述柔性电路所述多层中的第一层具有根据ASTM D-1004-09大于8.0N(1.8lbf)的初始撕裂强度。
5.如权利要求1-4中任一所述的医疗器械，其中所述第一层为由增强聚合物材料形成的第一绝缘层，而所述柔性电路包括多条传导迹线，所述传导迹线插入在所述第一绝缘层和由聚合物材料形成的第二绝缘层之间。
6.如权利要求5所述的医疗器械，其中所述增强聚合物材料包括多根大体垂直于所述导管杆所述纵轴定向的纤维。
7.如权利要求5所述的医疗器械，其中所述增强聚合物材料包括大体垂直于所述导管杆所述纵轴定向的聚合物链。
8.如权利要求7所述的医疗器械，其中所述第二绝缘层的所述聚合物材料包括大体平行于所述导管杆所述纵轴定向的聚合物链。
9.如权利要求5所述的医疗器械，其中所述增强聚合物材料包括多根纤维，所述多根纤维具有逐渐减小的外直径。
10.如权利要求1所述的医疗器械，其中所述第一层为超细纤维层。
11.如权利要求10所述的医疗器械，其中所述超细纤维层包括第一开口和第二开口，
其中所述电极组件包括第一电极和第二电极，所述第一电极延伸穿过所述第一开口与所述柔性电路的第一传导迹线电接触，并且所述第二电极延伸穿过所述第二开口与所述柔性电路的第二传导迹线电接触。
12.如权利要求10或11所述的医疗器械，其中所述超细纤维层定位在所述柔性电路的第一绝缘聚合物层和第二绝缘聚合物层之间。
13.一种形成用于组织消融的医疗器械的方法，包括：
提供电极组件，所述电极组件被构造成具有多根被插入在由增强聚合物材料形成的第一绝缘层和由聚合物材料形成的第二绝缘层之间的传导迹线的柔性电路；并且
将所述柔性电路安装到球囊导管的可充胀球囊的外表面上。
14.如权利要求13所述的方法，其中所述柔性电路被安装到所述可充胀球囊的所述外表面上，所述柔性电路具有大体垂直于所述可充胀球囊中心纵轴定向的所述增强聚合物材料的纤维。
15.如权利要求13所述的方法，其中所述柔性电路被安装到所述可充胀球囊的所述外表面上，所述柔性电路具有大体垂直于所述可充胀球囊中心纵轴定向的所述增强聚合物材料的聚合物链。
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