CN105658163B - 去神经柔性电路中的嵌入式热电偶 - Google Patents

去神经柔性电路中的嵌入式热电偶 Download PDF

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CN105658163B
CN105658163B CN201480058635.5A CN201480058635A CN105658163B CN 105658163 B CN105658163 B CN 105658163B CN 201480058635 A CN201480058635 A CN 201480058635A CN 105658163 B CN105658163 B CN 105658163B
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曹宏
肯尼思·R·拉森
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Abstract

一种用于交感神经消融的医疗器械可包括导管杆、设置在导管杆上或联接至导管杆的可扩张构件以及多个细长电极组件，每个电极组件构造为具有多层的柔性电路。可扩张构件可配置成在非扩张形态与扩张形态之间转换。多个电极组件可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包括在多层内的温度传感器。

Description

去神经柔性电路中的嵌入式热电偶
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10月25日提交的美国临时申请序列号第61/895,788的优先权，其整个内容以引用方式并入本文。
技术领域
本发明有关医疗器械以及制造医疗器械的方法。更特别地，本发明有关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
一种用于交感神经消融的医疗器械可包括导管杆；设置在导管杆上的可扩张球囊，该球囊能够在非扩张形态与扩张形态之间转换；以及多个细长电极组件，每个电极组件构造为具有多层的柔性电路。多个电极组件可设置在球囊的外表面上。多个电极组件中的每一个可包括嵌入在多层内的温度传感器。
一种用于交感神经消融的医疗器械可包括导管杆；联接至导管杆的可扩张构件，该可扩张构件能够在非扩张形态与扩张形态之间转换；以及多个细长电极组件，每个电极组件构造为具有多层及长度的柔性电路。多个电极组件可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包括定位于至少一个有源电极与至少一个接地电极之间的溅射热电偶。
一种用于在体通道内进行交感神经消融的医疗器械可包括导管杆；联接至导管杆的细长球囊，该球囊能够在非扩张形态与扩张形态之间转换；以及多个细长电极组件，每个电极组件构造为具有多层的柔性电路。多个电极组件可结合至球囊的外表面。多个电极组件中的每一个可包括温度传感器，其小于多个电极组件中的每一个的最大厚度的5％。
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为示范电极组件的一部分的仰视图；
图5为示范电极组件的一部分的仰视图；
图6为图4的局部剖面图；以及
图7为图5的局部剖面图。
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或多个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或多个电极(未示出)。这可包括将交感神经消融装置120有效联接至控制单元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/或信号以激活一个或多个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，一个或多个电极可如下所述消融组织(例如，交感神经)，一个或多个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，一个或多个电极组件可布置在可扩张构件130上，示于扩张状态。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中所产生的毁损灶在一些实施例中与在治疗区B中所产生的毁损灶绕周界(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示出示范电极组件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6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的外表面的底侧。图6示出图4中所示的仰视图的端视图，这样看起来可能关于本文所使用的某些相对术语为反向的。
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。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，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，其可钩住组织并能引发球囊展开和/或收缩的问题。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。
在温度传感器226处的电极组件200的大小和/或厚度可产生从可扩张构件130的外表面向外延伸的突出。在治疗程序之后，可扩张构件130可塌缩至塌缩递送形态，如本文进一步所讨论的，而且消融装置120可缩回到引导鞘套或导管14内。显著的突出可能使缩回到引导鞘套或导管14中更加困难和/或与期望的相比需要更大直径的引导鞘套或导管14。此外，突出可能会对可扩张构件130的可折叠特性产生负面影响，对于递送和取回两者而言。
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或多个子线束和/或连接器并最终联接至控制单元110。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。
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或多个电极组件，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，一个或多个电极组件和/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，其可减小电极组件的大小，以及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“钩住”引导导管(或其他装置)的端部的可能性，从而减少取回力。
图5示出示范电极组件300的仰视图或电极组件300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300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7中的截面所示，绝缘的基层302可为电极组件300提供基座。基层302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302可以是约0.010mm至约0.020mm厚。在一些实施例中，基层302可以是约0.015mm厚。也可考虑其他合适的厚度。供参考，基层302可形成电极组件300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的外表面的底侧。图7示出图5中所示的仰视图的端视图，这样看起来可能关于本文所使用的某些相对术语为反向的。
传导层304可包括多个层叠在基层302的顶部上的离散传导迹线。在一些实施例中，多个离散传导迹线可通过非传导材料横向隔开。传导层304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。也可以考虑其他合适的传导材料。在一些实施例中，传导层304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304和/或多个离散传导迹线可以是约0.018mm厚。也可以考虑其他合适的厚度。
绝缘层306可以离散地或连续地层叠在传导层304的顶部，使得传导层304可流体密封在基层302与绝缘层306之间。换句话说，绝缘层306可形成电极组件300的顶侧或表面，其可能背向可扩张构件130的外表面。像基层302，绝缘层306可由诸如聚酰亚胺的聚合物构造而成，尽管可考虑其他材料。在一些实施例中，绝缘层306可以是约0.010mm至约0.020mm厚。在一些实施例中，绝缘层306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306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302、传导层304和绝缘层306)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300的长度变化。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300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5中示出的电极组件300可包括远侧电极片308。在这个区域，基层302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300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分层的抵抗能力，如一些情况下当可扩张构件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308可包括多个层叠在基层302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310、有源电极迹线312和传感器迹线314。接地电极迹线310可包括横向偏离传感器接地片318的细长接地电极支撑件316。传感器接地片318可电联接至接地电极迹线310的细长接地电极支撑件316并可位于远侧电极片308的中心处。桥接部320可将传感器接地片318的最远侧部分连接至接地电极迹线310的细长接地电极支撑件316的远侧部分。随着桥接部320行进至传感器接地片318，桥接部320的宽度可逐渐减小。在一些实施例中，桥接部320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316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316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312可包括横向偏离细长接地电极支撑件316和传感器接地片318的细长有源电极支撑件317。传感器迹线314可位于远侧电极片308的中心处和/或与传感器接地片318对齐。细长有源电极支撑件317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317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300作为一整体的尺寸稳定性，从而防止在布置和使用期间变形。
如图5所示，接地电极迹线310和有源电极迹线312可各自包括多个电极322。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322可在绝缘层306上突出和/或延伸通过绝缘层306。在一些实施例中，多个电极322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317和细长接地电极支撑件316。多个电极322可附接和/或电连接至细长接地电极支撑件316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317从而界定多个有源电极。在一些实施例中，多个电极322可以是约0.030mm至约0.070mm厚。在一些实施例中，多个电极322可以是约0.051mm厚。在一些实施例中，多个电极322可在绝缘层306上方延伸约0.020mm至约0.050mm。在一些实施例中，多个电极322可在绝缘层306上方延伸约0.038mm。此外，每个电极可具有倒圆角以降低剐住其他装置和/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312和342相关联的多个有源电极可用作单极电极，其中接地电极迹线310在那些电极的通电期间是断开的。
传感器迹线314可位于远侧电极片308的中心处并可电连接至传感器接地片318以形成温度传感器326，如热电偶(例如，T型配置：铜/康铜)。在一些实施例中，温度传感器326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326可设置或定位于多个有源电极与多个接地电极之间。热电偶可在两种不同金属的接合处基于接合处的温度产生电压差，如本领域中已知的。在一些实施例中，等温接合处可形成于电极组件300的近端处，与电极片和/或多个电极隔开并且热隔离。在一些实施例中，传感器接地片318可形成为在传导层304内的电沉积铜的离散迹线，如上面所讨论的。在一些实施例中，传感器迹线314的远端部分，在一些情况下整个传感器迹线314可由例如康铜(即，铜镍合金)、镍-铬或其他合适的传导材料制成。在一些实施例中，温度传感器326可由与传感器接地片318相重叠的传感器迹线314的远端部分形成，使得传感器迹线314与传感器接地片318直接接触。在一些实施例中，温度传感器326可通过在传感器接地片318上溅射(或其他合适的方式)传感器迹线314的远端部分而形成，从而形成溅射热电偶。
在一些实施例中，温度传感器326可具有约0.100mm至约2.000mm的长度，以及约0.100mm至约0.800mm的宽度。在一些实施例中，温度传感器326可具有约1.000mm的长度以及约0.500mm的宽度。在另一实施例中，温度传感可具有约0.2mm的长度以及0.01mm的宽度。可考虑其他大小和/或尺寸。使用溅射工艺形成温度传感器326的优点在于溅射减少了电极组件300的总体或最大厚度。在一些实施例中，与传感器接地片318重叠(即，形成温度传感器326)的传感器迹线314的远端部分可具有约0.0002mm的厚度。换句话说，与热敏电阻相比，溅射热电偶的厚度可以忽略不计。在一些实施例中，在温度传感器326处的电极组件300(即，包括多个层和温度传感器326)的总厚度可以是约0.046mm。在一些实施例中，温度传感器326可小于在温度传感器326处的电极组件300的总厚度的5％。在一些实施例中，温度传感器326可小于在温度传感器326处的电极组件300的总厚度的1％。
在一些实施例中，温度传感器326可嵌入在基层302与绝缘层306之间，使得温度传感器326流体密封在柔性电路和/或电极组件300内。换句话说，在一些实施例中，温度传感器326可能没有定位在电极组件300的外表面上，反之，温度传感器226(热敏电阻)定位在电极组件200的外表面上或从电极组件200的外表面向外延伸。在一些实施例中，没有突出可形成于在温度传感器326处的电极组件300的底侧上。例如，在扁平形态下(例如，图3)，电极组件300面向可扩张构件130的外表面的底侧可形成不间断的表面。在一些实施例中，在扁平形态下(例如，图3)，电极组件的底侧可包括(和/或不间断的表面可形成)基本连续的平面，其中温度传感器326在电极组件300的适当位置处。换句话说，温度传感器326不突出或者不向外延伸通过基层302或不从基层302向外延伸。在电极组件300的底侧没有突出可增强电极组件300至可扩张构件130的附着力，以及可扩张构件130在塌缩递送形态下的可折叠性。在一些实施例中，多个层可沿电极组件300的长度形成大致恒定的厚度。在一些实施例中，电极组件300(包括多个层、温度传感器326和多个电极322)的最大厚度可以是约0.035mm至约0.100mm。在一些实施例中，电极组件300的最大厚度可以是约0.084mm。在一些实施例中，温度传感器326可小于电极组件300最大厚度的0.5％。
类似于上面的温度传感器226，在接触细长有源电极支撑件317的多个有源电极与接触细长接地电极支撑件316的多个接地电极之间布置温度传感器326，温度传感器326可测量代表多个电极322和/或邻近和/或接触多个电极322的组织的温度。
在温度传感器326(或没有温度传感器326)处的电极组件300的相对大小和/或厚度可避免产生从可扩张构件130的外表面向外延伸的突出。在治疗程序之后，可扩张构件130可塌缩至塌缩递送形态，如本文进一步所讨论的，并且消融装置120可缩回到引导鞘套或导管14内。没有突出可使缩回到引导鞘套或导管14中更容易和/或允许使用与另外的要求相比更小直径的引导鞘套或导管14。此外，没有突出可对可扩张构件130的可折叠特性产生积极影响，对于递送和取回两者而言。
从远侧电极片308向近侧移动，结合的基层302、传导层304和绝缘层306可减小横向宽度至中间辫328。这里，如图5所示，传导层304可形成为包括中间接地线330、中间有源电极线332和中间传感器线334，它们分别为远侧电极片308的接地电极迹线310、有源电极迹线312和传感器迹线314共同延伸的迹线。
从中间辫328继续向近侧移动，结合的基层302、传导层304和绝缘层306可增加横向宽度以形成近侧电极片336。近侧电极片336的构建可类似于远侧电极片308，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336可关于沿中间接地线330延伸的中心纵轴线G-G横向偏离远侧电极片308。中间有源电极线332和中间传感器线334可沿各自关于中心轴线G-G平行的轴线与近侧电极片336共同横向延伸。
从近侧电极片336开始，结合的基层302、传导层304和绝缘层306可减小横向宽度以形成近侧辫338。近侧辫338可包括近侧接地线340、近侧有源电极线342和近侧传感器线344，以及中间有源电极线332和中间传感器线334。近侧辫338可包括连接器(未示出)使得能够联接至一个或多个子线束和/或连接器并最终联接至控制单元110。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300可具有远侧电极片308和近侧电极片336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330/340一起可沿中心轴线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，近侧辫的宽度可仅为中间辫328宽度的约1.5倍，而不是在每个电极片具有独立接地线的情况下的约两倍。因此，近侧辫338可比并排定位的两个中间辫328更窄。
在一些实施例中，电极组件300可沿预定折叠线设置或另外界定预定折叠线，可扩张构件130可在收缩后沿该预定折叠线折叠。在一些实施例中，预定折叠线可有助于可扩张构件130的再折叠。
在一些实施例中，电极组件300可沿可扩张构件130的整个长度大致直线延伸，或沿可扩张构件130的整个长度与纵轴线L-L成一角度大致直线延伸。在一些实施例中，电极组件可在近侧区域中平行于纵轴线延伸，随后在远侧区域中弯曲为成一角度取向(未示出)。电极组件300可使球囊沿电极组件300的线折叠，减少了将消融装置120取回至引导鞘套或导管14中所需的取回力，并允许使用较小直径的引导鞘套。例如，可使用6Fr或7Fr的引导导管14，这在某些程序(例如，肾程序)中提供了优势，之前使用8Fr的引导鞘套。电极组件300还可降低剪切力或改进球囊的再折叠配置效率，从而降低了电极组件300从可扩张构件130的分层。
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或多个交感神经。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300)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
Figure BDA0000973508480000141
)，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 BDA0000973508480000142
)，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 BDA0000973508480000143
的聚酯弹性体)，聚酰胺(例如，拜尔公司出售的
Figure BDA0000973508480000144
或埃尔夫阿托公司出售的
Figure BDA0000973508480000145
)，弹性体聚酰胺，嵌段聚酰胺/醚，聚醚嵌段酰胺(PEBA，例如以
Figure BDA0000973508480000146
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 BDA0000973508480000147
)，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 BDA0000973508480000148
)，聚砜，尼龙，尼龙-12(诸如EMS American Grilon公司出售的
Figure BDA0000973508480000149
)，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 BDA00009735084800001410
625的UNS:N06625，诸如
Figure BDA00009735084800001411
的UNS:N06022，诸如
Figure BDA00009735084800001412
的UNS:N10276，其他
Figure BDA00009735084800001413
合金等)的其他镍合金，镍-铜合金(例如，诸如
Figure BDA00009735084800001414
400，
Figure BDA00009735084800001415
400，
Figure BDA00009735084800001416
400等的UNS:N04400)，镍-钴-铬-钼合金(例如，诸如
Figure BDA00009735084800001417
等的UNS:R30035)，镍-钼合金(例如，诸如
Figure BDA00009735084800001418
ALLOY
Figure BDA00009735084800001419
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 BDA00009735084800001420
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 BDA0000973508480000161
等的UNS:R30003)，镍-钴-铬-钼合金(例如，诸如
Figure BDA0000973508480000162
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 (14)

1.一种用于交感神经消融的医疗器械，包括：
导管杆；
设置在所述导管杆上的可扩张球囊，所述可扩张球囊能够在非扩张形态与扩张形态之间转换；以及
多个细长电极组件，每个所述电极组件构造为具有多层的柔性电路，所述多层包括绝缘层和面向所述可扩张球囊的基层，所述多个细长电极组件附接至所述可扩张球囊的外表面上；
其中，所述多个细长电极组件中的每一个包括嵌入在所述多层内所述基层与所述绝缘层之间的温度传感器和传感器接地片，并且其中所述传感器接地片在所述温度传感器与所述绝缘层之间。
2.根据权利要求1所述的医疗器械，其中所述多个细长电极组件中的每一个包括多个电极。
3.根据权利要求2所述的医疗器械，其中所述多个细长电极组件中的每一个包括多个有源电极和多个接地电极。
4.根据权利要求3所述的医疗器械，其中所述温度传感器定位于所述多个有源电极与所述多个接地电极之间。
5.根据权利要求1-4中任一项所述的医疗器械，其中所述可扩张球囊为非顺应性球囊，所述多个细长电极组件随着所述可扩张球囊展开和折叠。
6.根据权利要求1-4中任一项所述的医疗器械，其中所述多层和所述温度传感器相结合以界定在所述温度传感器处所述多个细长电极组件中的每一个的总厚度。
7.根据权利要求6所述的医疗器械，其中所述温度传感器为溅射热电偶。
8.根据权利要求7所述的医疗器械，其中所述温度传感器小于所述总厚度的5％。
9.根据权利要求7所述的医疗器械，其中所述温度传感器小于所述总厚度的1％。
10.根据权利要求1所述的医疗器械，其中所述柔性电路沿所述温度传感器的至少一个区域具有大致恒定的厚度。
11.根据权利要求10所述的医疗器械，其中所述柔性电路不具有邻近所述温度传感器的径向突起。
12.一种用于交感神经消融的医疗器械，包括：
导管杆；
联接至所述导管杆的可扩张构件，所述可扩张构件能够在非扩张形态与扩张形态之间转换；以及
多个细长电极组件，每个所述电极组件构造为具有多层及长度的柔性电路，所述多层包括绝缘层和面向所述可扩张构件的基层，所述多个细长电极组件附接至所述可扩张构件的外表面上；
其中，所述多个细长电极组件中的每一个包括嵌入在所述多层内所述基层与所述绝缘层之间的溅射热电偶和传感器接地片，其中所述传感器接地片在所述溅射热电偶与所述绝缘层之间，并且其中所述溅射热电偶定位于至少一个有源电极与至少一个接地电极之间。
13.根据权利要求12所述的医疗器械，其中所述柔性电路沿所述溅射热电偶的至少一个区域具有大致恒定的厚度。
14.根据权利要求12-13中任一项所述的医疗器械，其中所述柔性电路不具有邻近所述溅射热电偶的径向突起。
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