CN105530885B - 具有气相沉积覆盖层的消融球囊 - Google Patents

具有气相沉积覆盖层的消融球囊 Download PDF

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CN105530885B
CN105530885B CN201480050333.3A CN201480050333A CN105530885B CN 105530885 B CN105530885 B CN 105530885B CN 201480050333 A CN201480050333 A CN 201480050333A CN 105530885 B CN105530885 B CN 105530885B
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electrode assemblies
balloon
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帕特里克·A·哈夫科斯特
玛丽·M·拜伦
卡斯·A·汉森
马丁·R·威拉德
德里克·C·苏特米斯特
罗伯特·N·斯夸尔
K·雅布伦斯基 布赖恩
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Abstract

本发明公开了医疗器械及其制造和使用方法。一示范医疗器械可包括导管杆。可扩张球囊可连结至导管杆。球囊能够在折叠形态和扩张形态之间转换。多个细长电极组件可设置在球囊上。覆盖层可设置在电极组件上。电极组件的一些部分可不具有覆盖层。

Description

具有气相沉积覆盖层的消融球囊
相关申请的交叉引用
本申请根据《美国法典》35章§119要求于2013年9月13日提交的美国临时申请序列第61/877,755号的优先权，其整个内容以引用方式并入本文。
技术领域
本发明关于医疗器械以及制造医疗器械的方法。更特别地，本发明关于用于交感神经消融的医疗器械。
背景技术
已研发出各种各样医用的，例如，血管内使用的体内医疗器械。这些器械中的一些包括导丝、导管等。这些器械通过各种不同制造方法中的任何一种进行制造并可根据各种方法中的任何一种进行使用。在已知的医疗器械和方法中，各自具有某些利弊。不断需要提供替代的医疗器械以及用于制造和使用医疗器械的替代方法。
发明内容
本发明提供了用于医疗器械的设计、材料、制造方法和使用替代形式。一示范医疗器械可包括导管杆、连结至导管杆的可扩张球囊、多个设置在球囊上的细长柔性电极组件和在电极组件上设置的覆盖层，其中球囊能够在未扩张形态和扩张形态之间转换。
作为上述实施方式的替代或附加，电极组件的一个或多个区域不具有覆盖层。作为上述任何实施方式的替代或附加，电极组件各包括至少一个电极。作为上述任何实施方式的替代或附加，至少一个电极不具有覆盖层。作为上述任何实施方式的替代或附加，覆盖层将电极组件密封到球囊上。作为上述任何实施方式的替代或附加，球囊是非顺应性球囊，覆盖层与球囊一起展开和折叠。作为上述任何实施方式的替代或附加，覆盖层气相沉积到球囊上。作为上述任何实施方式的替代或附加，覆盖层溅射涂覆到球囊上。作为上述任何实施方式的替代或附加，覆盖层电镀到球囊上。作为上述任何实施方式的替代或附加，覆盖层是聚合物。作为上述任何实施方式的替代或附加，覆盖层是聚对二甲苯。作为上述任何实施方式的替代或附加，覆盖层的厚度为约0.0001至0.0002英寸。作为上述任何实施方式的替代或附加，电极组件中至少一些包括温度传感器。作为上述任何实施方式的替代或附加，温度传感器定位在其中一个电极组件的底表面与球囊的外表面之间。作为上述任何实施方式的替代或附加，电极组件中至少一些包括相邻的双极电极对。作为上述任何实施方式的替代或附加，电极组件中至少一些包括单极电极。作为上述任何实施方式的替代或附加，球囊是非顺应性球囊。作为上述任何实施方式的替代或附加，电极组件沿球囊与球囊的纵轴线成一角度延伸。作为上述任何实施方式的替代或附加，电极组件在球囊上以螺旋方式延伸。
本文还公开了一种用于制造消融器械的示范方法。该方法可包括提供可扩张构件，将一个或多个电极组件附接至可扩张构件的外表面，以及用聚合物涂覆可扩张构件和电极组件的至少一部分。作为上述实施方式的替代或附加，涂覆包括气相沉积。作为上述任何实施方式的替代或附加，涂覆包括溅射涂覆。作为上述任何实施方式的替代或附加，涂覆包括喷涂。作为上述任何实施方式的替代或附加，涂覆包括浸涂。作为上述任何实施方式的替代或附加，涂覆包括电镀。作为上述任何实施方式的替代或附加，一个或多个电极组件包括一个或多个电极，其中在涂覆前，该方法包括覆盖该一个或多个电极，该方法还包括在涂覆步骤后从该一个或多个电极上移除聚合物的步骤。作为上述任何实施方式的替代或附加，移除聚合物包括激光消融。作为上述任何实施方式的替代或附加，移除聚合物包括刮除。作为上述任何实施方式的替代或附加，涂覆包括涂覆整个可扩张构件。作为上述任何实施方式的替代或附加，涂覆包括涂覆电极组件，以及仅未被电极组件覆盖的可扩张构件的一部分。作为上述任何实施方式的替代或附加，聚合物是聚对二甲苯。作为上述任何实施方式的替代或附加，涂覆产生约0.0001至0.0002英寸厚的聚合物层。
本发明公开了另一个示范医疗器械。该医疗器械可包括导管杆。可扩张球囊可连结至导管杆。柔性电路可沿球囊设置。柔性电路可包括双极电极对。覆盖层可沿柔性电路的至少一部分进行溅射涂覆。
上面有关一些实施方式的概述并不旨在描述本发明每个公开的实施方式或每个实施方式。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方式。
附图说明
结合附图考虑以下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器械的示意图；
图2为交感神经消融器械的示范可扩张构件的立体图；
图3为图2所示的可扩张构件处于展开或平坦形态的局部俯视图；
图4为示范电极组件的一部分的俯视图；
图5为图4的局部剖面视图A-A；
图6为图4的局部剖面视图B-B；
图7为替代性可扩张构件处于展开或平坦形态的局部俯视图；以及
图8示出在医疗器械上涂覆覆盖层。
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示例示出，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方式。相反地，本发明涵盖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，附图不必成比例，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方式。
对于以下定义的术语，除非是在权利要求或者是在本说明书的其它地方给出了不同的定义，否则应当使用这些定义。
无论是否明确指出，本文假定所有数值均通过术语“大约”来修饰。术语“大约”，在数值情况下，通常是指本领域技术人员会认为是与所述值相当(即，具有相同的功能或结果)的数值范围。在许多情况下，术语“大约”可包括四舍五入为最接近有效数字的数值。术语“大约”的其他使用(即，在除了数值之外的情况下)，可假定具有它们通常且常规的定义，根据说明书语境理解并与说明书的语境相一致，除非另外说明。
由端点限定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”和“该”包括复数指代，除非文中清楚地表明并非如此。如在本说明书和所附权利要求中所使用的，术语“或者”通常使用其包括“和/或”的含义，除非文中清楚地表明并非如此。
应当注意到，在本说明书中提及“一实施方式”，“一些实施方式”，“其他实施方式”等表明描述的该实施方式可包括特定的特征，结构，或特性，但不必每个实施方式都包括该特定的特征，结构，或特性。此外，这种短语不必指代同一实施方式。而且，当在一实施方式中描述特定的特征，结构，或特性时，本领域技术人员应当理解，不论是否明确描述，这种特征，结构，和/或特性也可用于其他实施方式中，除非清楚地表明相反。即，以下描述的各种单个的元件，即使没有以特定组合明确示出，虽然如此，可以预期，其可相互组合或设置以形成其他的附加实施方式或者补充和/或充实描述的实施方式，如本领域技术人员理解的。
某些治疗旨在暂时或永久中断或者改变选择的神经功能。在一些实施方式中，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高血压、充血性心力衰竭、糖尿病或与高血压、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。交感神经响应的结果可能是，例如，增加血压。对一些延伸到肾脏的神经(例如，邻近肾动脉设置或以其他方式沿肾动脉设置)的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)。
本发明的一些实施方式涉及能量产生及控制装置，通常用于靶组织的治疗以实现治疗效果。在一些实施方式中，靶组织是包含神经或接近神经的组织。在其他实施方式中，靶组织是交感神经，包括例如邻近血管的交感神经。在其他实施方式中，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。
在本发明一些实施方式中，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、以及许多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够瞄准神经，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以准确能量剂量像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。
在一些实施方式中，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或多个治疗参数或者识别是否需要附加治疗。例如，去神经***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。
关于肾神经消融和/或调制讨论了本文描述的许多装置和方法。然而，可以预期，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***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是示范交感神经消融***100的示意图。***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)。使用中，交感神经消融装置120可前进穿过诸如主动脉A的血管至肾动脉RA内的位置处。这可包括推进交感神经消融装置120穿过引导鞘套或导管14。当依照要求定位好时，可激活交感神经消融装置120以激活一个或多个电极(未示出)。这可包括可操作地连接交感神经消融装置120至控制单元110，控制单元110可包括射频(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可包括具有连接器20的线或传导部件18，连接器20可连接至控制单元110上的连接器22和/或连结至控制单元110的线24。在至少一些实施方式中，控制单元110还可用来供给/接收适当的电能和/或信号以激活一个或多个设置在交感神经消融装置120远端或远端附近的传感器。当适当地激活时，如以下描述的，电极能够消融组织(例如，交感神经)，并且传感器可用来检测期望的物理和/或生物参数。
在一些实施方式中，交感神经消融装置120可包括细长管状部件或导管杆122，如图2所示。在一些实施方式中，细长管状部件或导管杆122可配置成沿导丝或其他细长医疗器械滑动前进至靶部位。在一些实施方式中，细长管状部件或导管杆122可配置成在引导鞘套或导管14内滑动前进至靶部位。在一些实施方式中，细长管状部件或导管杆122可配置成在导丝上、在引导鞘套或导管14内，或者其组合前进至靶部位。可扩张构件130可设置在细长管状部件或导管杆122的远侧区域中、远侧区域上、远侧区域周围或者远侧区域附近。
例如，如图2所示，在一些实施方式中，电极组件可按照多个大体柱状的治疗区A-D布置在可扩张构件130上，这里可扩张构件130示于扩张状态。在其他实施方式中，可扩张构件130或治疗***的其他组件可包括附加电极组件，其不在治疗区或者另外不使用或不配置成传送治疗能量。
治疗区A-D和相关联的电极组件140a-d进一步示于图3中，其是图2中可扩张构件130的一部分的“展开”描绘。治疗区A-D可沿纵轴线L-L相互纵向毗邻，并可配置成使电极组件施加的能量产生可重叠或不重叠的治疗。由纵向相邻的双极电极组件140a-d施加的治疗可沿纵轴线L-L周向非连续。例如，参照图3，在一些实施方式中，治疗区A中产生的毁损灶(lesion)与治疗区B中产生的毁损灶关于周向(在该图中是关于L-L的横向)重叠最小。然而，在其他实施方式中，由电极组件(诸如图3中示出的电极组件)施加的能量可至少在某种程度上纵向、周向，和/或以其他方式重叠。各电极极板组件可包括四个元件，其是远侧电极极板150a-d、中间尾部160a-d、近侧电极极板170a-d和近侧尾部180b、d(未示出电极极板组件140a、140c的近侧尾部)。
图4示出示范电极组件200的俯视图。电极组件200可构建为具有多层的柔性电路。这种层可以是连续或非连续的，即，由离散部分组成。示于图5和6中，绝缘的基层202可提供电极组件200的基座。基层202可由诸如聚酰亚胺的聚合物构建而成，尽管其他材料也可以考虑。由多个离散迹线组成的导电层204可层叠在基层202的顶部。导电层204可以是，例如，电沉积铜的层。也可以考虑其他材料。在一些实施方式中，一个或多个传导元件可溅射涂覆或电镀到可扩张构件上。绝缘层206可离散或连续地层叠在导电层204的顶部，使得导电层204可流体密封在基层202与绝缘层206之间。像基层202一样，绝缘层206可由诸如聚酰亚胺的聚合物构建而成，尽管其他材料也可以考虑。在一些实施方式中，绝缘层206的厚度可以从大约0.01mm到大约0.02mm。在其他实施方式中，绝缘层206可以是完整或部分的聚合物涂层，诸如聚四氟乙烯或硅酮。也可以考虑其他材料。
示于图4中的电极组件200可包括远侧电极极板208。在这个区域中，基层202可形成矩形形状。这并非旨在限制。也可以考虑其他形状。如所示的，电极组件200可包括多个开孔以提供更多的柔性，并且组件的极板和其他部分可包括圆的或弯曲的角，过渡区和其他部分。在一些情况下，开孔和圆的/弯曲的特征可提高组件抵抗与可扩张装置分层的能力，在一些情况下，当可扩张装置反复扩张和塌缩时(这也是可扩张装置从保护鞘套中展开和缩回到保护鞘套中所必需的)，诸如在手术过程中治疗多个部位时可能需要的，分层可能出现。
远侧电极极板208可包括多个层叠在基层202顶部的离散迹线。这些迹线可包括接地迹线210、有源电极迹线(active electrode trace)212和传感器迹线214。接地迹线210可包括从传感器接地极板218横向偏移的细长电极支撑部216。传感器接地极板218可电连结至接地迹线210的细长电极支撑部216，并可位于远侧电极极板208的中心。桥接部220可将传感器接地极板218的最远侧部分连接至接地迹线210的细长电极支撑部216的远侧部分。随着桥接部220行进至传感器接地极板218，桥接部220的宽度可逐渐减小。在一些实施方式中，桥接部220可具有相对一致且细的宽度，使桥接部能够具有期望的柔性量。细长电极支撑部216在它的近端可宽度逐渐减小，然而，这不是必需的。在一些实施方式中，细长电极支撑部216可在它的近侧部分突然转变成细得多的迹线，使其能够具有期望的柔性量。通常，可使迹线的弯曲度(这里显示出颈缩)最优化以降低球囊再俘获力以及任何挂住(可能存在较尖锐的轮廓)的可能性。也可使迹线的形状和位置最优化以提供电极组件200整体的尺寸稳定性，以防止安置和使用过程中的变形。
***100可用来执行根据本发明一个非限制性实施方式的治疗方法。例如，控制单元110可以可操作地连结至消融装置120，其可***到体通道中使得可扩张构件130(具有多个电极组件)可放置成邻近需要治疗的体通道的第一段。将消融装置120放置在需要治疗的体通道的第一段可按照传统方法执行，例如，在荧光镜引导下沿着导丝。一旦***，可扩张构件130可从塌缩递送形态扩张至扩张形态，例如，在球囊的情况下通过大约2-10atm的增压流体。这可造成可扩张构件130的电极和/或电极组件与体通道的第一段形成接触。
在一些实施方式中，球囊可由聚对苯二甲酸乙二醇酯(PET)制成，并且基层202可用粘合剂结合至球囊。基层202一般是平坦的并且比较软的圆球囊硬。一般是平坦的电极组件200在使用后再折叠期间可能抵抗顺应圆形的球囊形状，这可能需要很高的取出力。在一些情况下，一般是平坦的电极组件200可在其边缘产生捕获点(catch point)，其可能导致电极组件200分层。
使用包括球囊(其具有一个或多个连结至其上的电极组件)的医疗器械，例如本文中描述的，可能是令人满意的。然而，在一些情况下，电极组件可能包括相对刚性的材料。于是，球囊收缩时，电极组件可能倾向于变平和/或加宽。这样配置时，当将医疗器械(例如，包括附接的电极组件)从近侧缩回到引导导管中时，电极组件或其边缘可能钩住引导导管的边缘。本文披露的医疗器械包括在缩回到例如引导导管中时，可降低医疗器械的电极组件或其他结构“钩住”引导导管(或其他器械)端部的可能性的结构特征，这样导致取出力减小。
在一些实施方式中，覆盖层或薄涂层400可设置在具有附装的电极组件200的可扩张构件130上。涂层400可将电极组件密封在球囊上。在一些实施方式中，使用涂层可使得使用更少的粘合剂将电极组件附装到球囊上。例如，粘合剂可仅涂至电极组件的背面以结合至球囊。粘合剂可有助于实现电极组件的刚性，这样减少粘合剂的量可增加器械的柔性。在具有溅射涂覆或电镀传导元件的实施方式中，涂层将元件密封至球囊，这提供了附装元件的方法，不然该元件对球囊的附着力可能很差。在一些实施方式中，涂层可以是化学气相沉积的聚对二甲苯、聚(对二甲苯)聚合物、如添加甲基丙烯酸酯基和/或添加乙烯基的聚对二甲苯共聚物、石墨烯、氮化硅、氮氧化硅、碳化硅或另一种聚合物。
在一些实施方式中，涂层可以是聚对二甲苯C(parylene C)、单氯代取代化合物(mono-chloro substituted compound)、聚对二甲苯N(parylene N)、未取代化合物、聚对二甲苯D(parylene D)、二氯代取代化合物(di-chloro substituted compound)、聚对二甲苯F(parylene F)、氟取代化合物或聚对二甲苯HT(parylene HT)。涂覆过程可以是气相沉积，其产生疏水性、惰性、透明、生物相容性的保形涂层，并提供对氧气、水分、化学品、溶剂和二氧化碳的屏障。涂层可以是约0.00001至0.001英寸厚，或约0.00005至0.0005英寸厚，或约0.0001至0.0002英寸厚。这些仅仅是示例。在一些实施方式中，涂覆过程可包括浸涂或喷涂。用于喷涂和/或浸涂的材料的示例包括硅酮分散体、聚四氟乙烯(PTFE)、聚酰亚胺、聚氨酯(包括脂肪族聚醚基热塑性聚氨酯(例如，Lubrizol的SG-60D)、聚乙烯吡咯烷酮(PVP)和聚醚嵌段酰胺(如
Figure BDA0000939640160000071
))。
如图8所示，涂覆过程可涉及由支撑件500悬浮消融装置120(具有附装的电极组件200的可扩张构件130)，以及进行气相沉积以在装置120上涂覆聚对二甲苯或其他聚合物的薄层。涂层可防止电极组件分层并可帮助球囊在扩张后再折叠。
各个电极以及不需要涂层的任何其他区域可在涂覆前进行掩盖或掩模，在涂覆后移除掩模以在电极上产生露出来的区域410。限定区域中(如电极上)涂层的移除也可通过激光消融或刮除来实现。在一些实施方式中，可涂覆涂层小于球囊的整个表面，如仅涂到电极组件的区域上。
图5示出远侧电极极板208的局部剖面A-A。电极222层叠在绝缘层206的一部分上，绝缘层206可具有多个通道(例如，孔)使得电极222能够连结至(导电层204的)接地迹线210的细长电极支撑部216。涂层400设置在装置上，其中电极222的区域没有涂层400。如图6所示，在没有电极222的区域中，涂层400可覆盖绝缘层206和电极组件的其他组件。
如图4所示，接地电极迹线210和有源电极迹线212可包括多个电极。可为每个电极迹线设置三个电极222，然而，可使用更多或更少的电极。另外，各电极222可具有倒圆角以降低挂住其他装置和/或组织的可能性。尽管在双极电极组件的情况下描述了电极222和相关联的迹线的以上说明，本领域技术人员应当意识到，相同的电极组件也可作用在单极模式下。例如，作为一个非限制性示例，与有源电极迹线212和242相关联的电极可用作单极电极，在这些电极通电的过程中，接地迹线210断开。
传感器迹线214可位于远侧电极极板208的中心并可包括面向传感器接地极板218的传感器电源极板224。这些极板可连接至温度传感器226的电源极和接地极，诸如热电偶(例如，T型构造：铜/康铜)或热敏电阻，如图6中描绘的局部剖面图所示。
温度传感器226可在近侧连接至传感器电源极板224，并可在远侧连接至传感器接地极板218。为了降低整体厚度，温度传感器226可定位在基层202的开孔中。在一些实施方式中，温度传感器226可以是热敏电阻。如所示的，温度传感器226可以在远侧电极极板208的非组织接触侧。于是，当温度传感器226并入到最终装置(诸如消融装置120)中时，温度传感器226可俘获在电极结构与球囊之间。这可能是有利的，因为表面安装的电子组件(像热敏电阻)通常具有尖锐的边缘和角，其可能钩住组织，并且可能造成球囊展开和/或收回的问题。这种布局也可防止焊接接头接触血液，因为焊料通常是非生物相容性的。而且，由于安置了温度传感器，可测量组织和电极222的温度表示。
从远侧电极极板208开始，结合的基层202、导电层204和绝缘层206的横向宽度可减小直至中间尾部228。这里，如图4所示，导电层204可形成包括中间接地线230、中间有源电极线232和中间传感器线234，其分别是远侧电极极板208的接地迹线210、有效电极迹线212和传感器迹线214共同延伸的迹线。
从中间尾部228开始，结合的基层202、导电层204和绝缘层206的横向宽度可增加以形成近侧电极极板236。近侧电极极板236可类似于远侧电极极板208构建而成，具有基本相同的电极几何形状和温度传感器布局，尽管可存在各种差异。然而，如所示的，近侧电极极板236可关于沿中间接地线230延伸的中心轴线G-G从远侧电极极板208横向偏移。中间有源电极线232和中间传感器线234可在各自平行于中心轴线G-G的轴线上与近侧电极极板236横向共同延伸。
从近侧电极极板236开始，结合的基层202、导电层204和绝缘层206的横向宽度可减小以形成近侧尾部238。近侧尾部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。近侧尾部238可包括连接器(未示出)以使近侧尾部238能够连结至一个或多个子线束和/或连接器，并最终连结至控制单元110。这些线中的每一个可沿各自平行于中心轴线G-G的轴线延伸。
如所示的，电极组件200可具有远侧电极极板208与近侧电极极板236关于轴线G-G不对称的布局。而且，两个电极极板的接地电极连同中间和近侧接地线230/240一起可沿轴线G-G大致对齐。已发现，这种布局可表现出某些优势。例如，由于基本共享同一接地迹线，近侧尾部的宽度可以仅是中间尾部228宽度的大约一点五倍，而不是各电极极板具有独立接地线的情况下的大约两倍宽。这样，近侧尾部238可以比两个中间尾部228更窄。
在一些实施方式中，多个电极组件310可扭绞在一起或者与可扩张构件130的纵轴线L-L成一角度倾斜，如图7所示。成一定角度的电极组件310可沿预定折叠线设置或者另外界定预定折叠线，可扩张构件130可在收缩后沿着该预定折叠线折叠。在一些实施方式中，成一定角度的电极组件310可帮助可扩张构件130拧在一起及再折叠。
电极组件310可沿其长度大致直线的，沿可扩张构件130的整个长度与纵轴线成一角度延伸。在其他实施方式中，电极组件可在近侧区域平行于纵轴线延伸，然后在远侧区域弯曲成一定角度的取向(未示出)。成一定角度的电极组件310可导致球囊旋转并沿成一定角度的细长部件310的线折叠，降低了使消融装置300退回到引导鞘套或导管14中所需要的取出力，并允许使用更小直径的引导鞘套。例如，可使用6Fr或7Fr的引导导管14，在肾手术中提供优势，而不是之前使用的8Fr的引导导管。成一定角度的电极组件310可降低剪力(shear force)或改善球囊再折叠轮廓效率(balloon refold profile efficiency)，因此降低了电极组件与可扩张构件130分层的可能性。
电极组件310在形式和功能上可类似于本文所公开的电极组件和/或柔性电路(例如电极组件200)。在至少一些实施方式中，电极组件310可直接附装至可扩张构件130，每个电极组件310可含有一个或多个电极极板325。每个电极极板325可包括一个或多个接地电极、一个或多个有源电极，和温度传感器，如上面所讨论的。在一些实施方式中，每个电极极板325的电极和传感器可按图4A中所示的方式进行布置。相邻电极组件310上的电极极板325可偏移，如图7所示。在其他实施方式中，电极极板325可沿可扩张构件130的长度具有螺旋取向，其可在可扩张构件130定位的腔或血管中形成至少一个完整(360度)的周向环。电极极板325可在围绕体通道的组织中的位置处提供加热，而不会损伤体通道的壁，以破坏位于围绕体通道壁的组织中的神经。螺旋取向是可取的有助于避免电极设置在垂直于体通道纵轴线的单个平面中时(即，形成周向环的环形电极或电极组)可能存在的狭窄增加的风险。
使用中，可推进消融装置120通过血管至邻近靶组织(例如，肾动脉内)的位置处。在一些实施方式中，靶组织可以是一个或多个在肾动脉周围的肾神经。当合适定位时，可扩张构件130可从塌缩递送形态扩张至扩张形态。这可将有源电极放置成抵住血管壁。可激活有源电极。消融能量可从有源电极通过靶组织(在这里肾神经可被消融、调制、或以其他方式受到影响)传递，并通过接地电极返回(在双极配置下)，或者通过共用的接地电极返回(在单极配置下)。
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那些通常与医疗器械相关的材料。为简明起见，以下谈论参照消融装置120。然而，这并不旨在限制本文公开的装置和方法，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
Figure BDA0000939640160000101
)，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
Figure BDA0000939640160000102
)，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
Figure BDA0000939640160000103
的聚酯弹性体)，聚酰胺(例如，拜尔公司出售的
Figure BDA0000939640160000104
或埃尔夫阿托公司出售的
Figure BDA0000939640160000105
)，弹性体聚酰胺，嵌段聚酰胺/醚，聚醚嵌段酰胺(PEBA，例如以
Figure BDA0000939640160000106
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，
Figure BDA0000939640160000107
)，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(polytrimethylene terephthalate)，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，
Figure BDA0000939640160000108
)，聚砜，尼龙，尼龙-12(诸如EMS American Grilon公司出售的
Figure BDA0000939640160000109
)，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
Figure BDA0000939640160000111
625的UNS:N06625，诸如
Figure BDA0000939640160000112
的UNS:N06022，诸如
Figure BDA0000939640160000113
的UNS:N10276，其他
Figure BDA0000939640160000114
合金等)的其他镍合金，镍-铜合金(例如，诸如
Figure BDA0000939640160000115
400，
Figure BDA0000939640160000116
400，
Figure BDA0000939640160000117
400等的UNS:N04400)，镍-钴-铬-钼合金(例如，诸如
Figure BDA0000939640160000118
等的UNS:R30035)，镍-钼合金(例如，诸如
Figure BDA0000939640160000119
ALLOY
Figure BDA00009396401600001110
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
Figure BDA00009396401600001111
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
Figure BDA0000939640160000121
等的UNS:R30003)，镍-钴-铬-钼合金(例如，诸如
Figure BDA0000939640160000122
等的UNS:R30035)，镍钛诺等，以及其他材料。
2013年1月25日提交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 (14)

1.用于交感神经消融的医疗器械，包括：
导管杆；
连结至所述导管杆的可扩张球囊，所述球囊能够在非扩张形态和扩张形态之间转换；
设置在所述球囊上的细长的多个电极组件,所述多个电极组件各包括一个或多个电极,所述电极组件构建为具有多层的柔性电路，所述多层至少包括绝缘的基层；以及
设置在所述多个电极组件上的覆盖层，其中所述覆盖层将所述多个电极组件密封到所述球囊上，并且
其中所述一个或多个电极没有所述覆盖层。
2.根据权利要求1所述的医疗器械，其中所述覆盖层溅射涂覆到所述球囊上。
3.根据权利要求1所述的医疗器械，其中所述多个电极组件中多个区域没有所述覆盖层。
4.根据权利要求1-3中任一所述的医疗器械，其中所述覆盖层气相沉积或电镀到所述球囊上。
5.根据权利要求1-3中任一所述的医疗器械，其中所述覆盖层是聚合物。
6.根据权利要求5所述的医疗器械，其中所述覆盖层是聚对二甲苯。
7.根据权利要求1-3中任一所述的医疗器械，其中所述多个电极组件中至少一些包括温度传感器。
8.根据权利要求7所述的医疗器械，其中所述温度传感器位于所述多个电极组件中一个的底表面与所述球囊的外表面之间。
9.用于制造医疗器械的方法，包括：
提供可扩张构件；
将一个或多个电极组件附接至所述可扩张构件的外表面，所述一个或多个电极组件各包括一个或多个电极,所述电极组件构建为具有多层的柔性电路，所述多层至少包括绝缘的基层；以及
用聚合物涂覆所述可扩张构件和所述一个或多个电极组件的至少一部分，其中涂覆将所述一个或多个电极组件密封到所述可扩张构件上，
其中所述一个或多个电极没有覆盖层。
10.根据权利要求9所述的方法，其中涂覆包括溅射涂覆。
11.根据权利要求9或10所述的方法，其中在涂覆前，所述方法包括覆盖所述一个或多个电极，所述方法还包括在所述涂覆步骤后从所述一个或多个电极上移除所述聚合物的步骤。
12.根据权利要求9或10所述的方法，其中涂覆包括涂覆所述一个或多个电极组件，以及仅未被所述一个或多个电极组件覆盖的所述可扩张构件的一部分。
13.根据权利要求10所述的方法，其中所述电极组件的一个或多个区域没有所述覆盖层。
14.根据权利要求9或10所述的方法，其中所述覆盖层是气相沉积的。
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