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CN105636538B - 具有柔性导线的球囊导管及其使用和制造的相关方法 - Google Patents

具有柔性导线的球囊导管及其使用和制造的相关方法 Download PDF

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CN105636538B
CN105636538B CN201480057298.8A CN201480057298A CN105636538B CN 105636538 B CN105636538 B CN 105636538B CN 201480057298 A CN201480057298 A CN 201480057298A CN 105636538 B CN105636538 B CN 105636538B
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elongate rod
energy delivery
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CN105636538A (zh
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马丁·R·威拉德
德里克·C·苏特米斯特
肯尼思·R·拉森
蒂莫西·A·奥斯特鲁特
帕特里克·A·哈夫科斯特
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    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
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Abstract

本发明公开了一种医疗器械及其使用或制造的相关方法。该医疗器械可包括用于神经调制的血管内导管。医疗器械包括细长杆，其具有近端区域、远端区域和在其之间延伸的腔。可扩张构件联接至细长杆的远端区域。一个或多个电导线从细长杆的近端区域延伸至可扩张构件。一个或多个电导线可具有直接缚至可扩张构件的外表面的远端区域。一个或多个能量输送区定位在可扩张构件上并联接至一个或多个电导线。

Description

具有柔性导线的球囊导管及其使用和制造的相关方法
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18日提交的美国临时申请序列号第61/893,032号的优先权，其整个内容以引用方式并入本文。
技术领域
本发明大体涉及用于神经调制和/或消融的经皮血管内器械。
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
本发明提供了医疗器械的设计、材料、制造方法及使用替代。示范医疗器械可包括用于交感神经调制和/或消融的医疗器械。该医疗器械可包括用于神经调制的血管内导管。该医疗器械包括细长杆，其具有近端区域、远端区域和在其之间延伸的腔。可扩张构件联接至细长杆的远端区域。一个或多个电导线从细长杆的近端区域延伸至可扩张构件，该一个或多个电导线具有缚至可扩张构件的外表面的远端区域。一个或多个能量输送区定位在可扩张构件上并联接至一个或多个电导线。
另一种示范医疗器械可包括用于调制神经的医疗器械。该医疗器械包括细长杆，其具有近端区域、远端区域和在其之间延伸的腔。可膨胀球囊联接至细长杆的远端区域。一个或多个线导体具有近端和远端，并覆盖有绝缘材料。一个或多个线导体从细长杆的近端区域延伸至可扩张构件。一个或多个线导体的至少一部分不具有绝缘材料，其界定了邻近一个或多个线导体的远端的一个或多个能量输送区。
又另一种示范医疗器械可包括用于调制神经的医疗器械。该医疗器械包括细长杆，其具有近端区域、远端区域和在其之间延伸的腔。可膨胀球囊联接至细长杆的远端区域。一个或多个圆线导体具有近端和远端，并覆盖有绝缘材料。一个或多个圆线导体从细长杆的近端区域延伸至可扩张构件。一个或多个圆线导体的至少一部分按蛇形方式缠绕，并不具有绝缘材料，其界定了邻近一个或多个线导体的远端的一个或多个能量输送区。一个或多个温度传感器定位在一个或多个能量输送区中至少一个的邻近。一个或多个能量输送区按双极对方式布置。
一些示范实施例的上述说明并不旨在描述每个公开的实施例或公开的主题的每个实施方式。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
结合附图考虑以下有关各种实施例的详细描述可更完整地理解所公开的主题，其中：
图1为原位示出交感神经调制系统的示意图。
图2为说明性医疗器械的远侧部分的侧视图。
图3为另一个说明性医疗器械的远侧部分的侧视图。
图4为另一个说明性医疗器械的远侧部分的侧视图。
图5为另一个说明性医疗器械的远侧部分的侧视图。
图6为另一个说明性医疗器械的远侧部分的侧视图。
图7为另一个说明性医疗器械的远侧部分的侧视图。
虽然公开的主题可作出各种改型和替代形式，但其细节已经由附图中的示范例示出，并会详细描述。然而，应理解，本发明并不将本发明的各方面限制为所述的特定实施例。相反地，本发明涵盖了落在本发明的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，其中在全部附图中，相同的附图标记表示相同的元件。附图不必成比例，其并不旨在限制请求保护的发明的范围。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。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。
在本文中假定所有的数字或数值由术语“约”进行修饰。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，单数不定冠词“一”以及定冠词“该”应认为是包括或以其他形式覆盖单数和复数指代，除非文中清楚地另外指出。换句话说，这些冠词适用于一个或多个指代。如在本说明书和所附权利要求中所使用的，术语“或”通常用来包括或以其他方式覆盖“和/或”，除非文中清楚地另外指出。
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，无论是否明确描述，与特定实施例相结合所描述的任何特定的特征、结构或特性旨在适用于、结合或替换至其他实施例中，除非清楚地表明相反。
某些治疗旨在暂时或永久中断或者改变选择的神经功能。在一些情况下，神经是交感神经。一个示范治疗是肾神经消融，其有时用来治疗与高血压、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。肾脏对充血性心力衰竭产生交感神经响应，除了其他影响之外，其增加水和/或钠不期望的滞留。对一些延伸到肾脏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。
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。在一个实施例中，靶组织包括肾动脉和相关联的肾神经。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。
虽然本文描述的许多装置和方法是关于肾神经调制进行讨论的，可以考虑，该装置和方法可用于期望进行神经调制和/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、疼痛管理、心脏消融、肺静脉隔离、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是在原位的说明性交感神经调制系统10的示意图。系统10可包括交感神经消融装置12。交感神经消融装置12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12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12穿过引导鞘套或导管14。系统10可包括一个或多个用于将电能提供至交感神经调制装置12的传导元件16。每个传导元件16的远端可附接至一个或多个在调制装置12的远端或远端附近的位置处的电极(未示出)。传导元件16的近端可连接至功率控制单元18，其可供给适当的电能以激活设置在调制装置12的远端或远端附近的一个或多个能量输送区或电极。另外，功率控制单元18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调制装置12的远端或远端附近的传感器。当传感器被适当激活时，能量输送区能够如下所述消融组织，并且传感器可用来感测期望的物理和/或生物参数。在一些情况下，能量输送区可包括电极。术语能量输送区和电极可认为是等同于本发明下面所述的能够消融邻近组织的元件。本发明中的“邻近组织”旨在覆盖充分接近消融电极的任何组织，且所涉及的位置和距离旨在根据应用和/或其他因素而变化。在一些情况下，返回电极贴片20可设置在腿上或患者身体的另一个常见位置上以完成电路。尽管，在一些情况下，返回电极贴片20可能不是必需的或可能没有提供。在一些实施例中，调制装置12可包括近侧集线器(未示出)，其可包括用于导丝、膨胀流体等的端口。
功率控制单元18可包括监测元件以监测诸如功率、电压、脉冲幅度、温度、力、接触、压力、阻抗和/或形状的参数以及其他合适的参数，其中具有沿交感神经调制装置12安装的传感器，以及用于执行期望程序的合适的控制装置。在一些实施例中，功率单元18可控制射频(RF)电极。在一些实施例中，电极可配置成在约为460kHz的频率上运行。然而，可使用在RF范围内任何期望的频率，例如450-500kHz。电极可配置成在合适的频率下运行并产生适当的信号。还可以考虑，根据需要可使用其他的消融装置，例如但不限于：电阻加热、超声、微波和激光装置，并且这些装置可要求能量以不同形式由功率单元18供给。
图2示出根据一个实施例的医疗器械(如交感神经调制装置12)的远侧部分。交感神经调制装置12可配置成将例如射频能量的消融能量输送至诸如肾神经的靶区。装置12可包括细长杆22、联接至细长杆22的远端区域24的可扩张构件26(诸如球囊)，以及一个或多个设置在球囊26的外表面上的电导线16。在一些实施例中，装置12还可包括一个或多个温度传感器，诸如但不限于热敏电阻42a、42b(统称为42)，用于监测邻近治疗区域的温度。虽然未明确示出，在一些情况下，温度传感器可以是热电偶。在这种情况下，可修改装置的布线以容纳热电偶。例如，热电偶可能需要独立的或滤过的、但非共享的接地路径。
细长杆22可具有细长柔性管状构造，其可插入到患者体内以进行医疗诊断/治疗。细长杆22可从远端区域24向近侧延伸至配置成留在患者体外的近端。尽管未示出，细长杆22的近端可包括附装其上用于连接其他治疗装置或提供便利其他治疗的端口的集线器。可以考虑，可修改细长杆22的刚性以形成用于血管树内各种脉管直径以及各种位置的调制装置12。
细长杆22可包括延伸通过其的一个或多个腔。在一些实施例中，细长杆22可包括一个或多个导丝或辅助腔。在一些情况下，细长杆22可包括用于注入流体(诸如用于可视化或其他目的(如引入医疗器械)的盐水或染料)的单独腔(未示出)。除了冷却体腔之外，流体可在消融过程中帮助冷却调制装置12。而且，腔可以按本领域已知的任何方式进行配置。例如，腔可沿细长杆22的整个长度延伸，如线上(over-the-wire)导管中，或者可仅沿细长杆22的远侧部分延伸，如单操作交换(SOE)导管中。这些实例并不旨在限制，而是一些可能的配置的实例。虽然未明确示出，调制装置12可进一步包括温度传感器/丝、输注腔、膨胀腔、不透射线的标记带、固定的导丝末端、导丝腔和/或其他组件以便利装置12在脉管系统中的使用和前进。在一些实施例中，膨胀腔可连接至系统以使流体循环通过球囊26，或连接至供给新的流体并收集所排出的流体的系统。
细长杆22的近端可位于功率控制单元18附近，尽管这不是必需的。在一些实施例中，细长杆22可限定大体圆形的横截面；然而，也可考虑其他的横截面形状，如矩形、半圆形、椭圆形、不规则形、圆柱形等。在一些情况下，细长杆22可具有适于容纳在期望的脉管中的截面形态。另外，集线器可连接至细长杆22的近端区域以便利连接至用于膨胀/收缩球囊26的膨胀系统，和/或便利将导丝或其他医疗器械插入其中。
球囊26可包括近端区域28、远端区域30、外表面32和用于接收膨胀流体的内部容积(未明确示出)。在一些情况下，球囊26可以是相对非顺应性的聚对苯二甲酸乙二醇酯(PET)球囊。这仅是示范例。在其他情况下，球囊26可由顺应性材料制成，诸如但不限于聚氨酯。在一些情况下，顺应性球囊可具有比非顺应性球囊更低的轮廓。在一些实施例中，交感神经调制装置12可包括在细长杆22内同轴延伸的细长内杆(未明确示出)。球囊26的远端30可附接至内杆，近端28可附接至细长杆22，尽管这不是必需的。内杆可界定导丝腔，而在细长杆22与内杆之间的环形区域可界定膨胀腔。然而，可以考虑其他构造。球囊26可通过激光定位、机械热结合、粘合剂、其他已知技术或以后开发的技术联接至装置。在其他实施例中，球囊26可形成为整体结构，固定地缚至或以其他方式联接至装置12。
内部容积可界定流体或空气进入的空间，操作过程中该流体或空气使球囊26膨胀。内部容积可连接至外部流体系统或贮存器(尽管未示出)以通过细长杆22中的膨胀腔输送或输注流体至球囊26。外部流体系统可设置在能够使流体进入或以其他方式便利流体进入的任何位置上，诸如细长杆22的近端。在一些情况下，膨胀流体可使球囊26径向和/或纵向膨胀。在使用过程中，球囊26可填充诸如盐水的流体以允许球囊扩张至期望的大小。虽然盐水是一种示范性流体，也可使用其他合适的流体，包括但不限于高渗溶液、造影溶液、和盐水或高渗盐水溶液与造影溶液的混合物。在一些情况下，球囊扩张可间接地通过监测引入到系统中的流体的体积来进行监测或者可通过放射线或其他已知的相关技术或之后开发的技术来进行监测。
各具有近端区域(未示出)和远端区域36的一个或多个传导元件或电导线16可从细长杆22的近端区域延伸至球囊26。电导线16的近端区域可连接至功率控制元件18，其可供给适当的电能以激活一个或多个设置在交感神经调制装置12的远端或远端附近的能量输送区或电极。在一些情况下，电导线16可沿球囊26的外表面32以及细长杆22的外表面延伸，尽管这并不是必需的。在一些实施例中，电导线可由导电材料制成，诸如但不限于：铜、金、银或铜箔等。这些仅仅是示范例。在一些情况下，电导线16可以是柔性的、大体圆形的线缆。然而，这不是必需的。可以考虑，电导线16可具有任何期望的横截面形状，诸如但不限于：正方形、矩形、长方形、多边形等。
电导线16可涂覆或以其他方式覆盖有绝缘体或绝缘材料34。在一些情况下，绝缘材料34可以是聚合材料，诸如但不限于：聚对苯二甲酸乙二醇酯(PET)、聚酰胺、聚酯、聚氨酯、含氟聚合物或聚酰亚胺。这些仅仅是示范例，也可考虑其他的绝缘材料、聚合物或其他材料。可以考虑，电导线16可使用任何已知的技术联接至细长杆22和/或球囊26，诸如但不限于：热结合、粘合剂结合、溶剂结合或任何其他当前已知的相关技术和/或以后开发的技术。可以考虑，电导线16和/或能量输送区38可在不使用聚合箔背衬的情况下缚至球囊26。不使用聚合背衬可减少将球囊26撤回至取回鞘套或引导导管(未示出)所需的力的量。
在一些情况下，绝缘材料34的一部分可移除以界定一个或多个能量输送区38a、38b、38c、38d(统称为38)。电导线16形成能量输送区38的部分可按期望的任何方式缠绕、盘绕或定位，诸如但不限于：蛇形、螺旋等。这可增加用于有效消融的能量输送区38的表面积。然而，这不是必需的。可以考虑，能量输送区38可以是电导线16的笔直区域。
在一些实施例中，电导线16和能量输送区38可设置成以双极模式输送能量，其中能量在被紧密地一起放置在球囊26上的能量输送区38之间输送，无需外部接地极板。例如，能量输送区38可以以形成若干双极对的方式设置。在图2的实施例中，示出了第一双极对40a和第二双极对40b(统称为40)。第一双极对40a可由第一能量输送区38a和不同的第二能量输送区38b形成。第二双极对40b可由第三能量输送区38c和第四能量输送区38d形成。热敏电阻42a或其他温度感测装置可邻近能量输送区38a、38b放置，热敏电阻42b或其他温度感测装置可邻近能量输送区38c、38d放置以监测邻近能量输送区38的温度。在一些情况下，功率控制单元18可基于邻近治疗区的温度控制能量的输送。
在一些情况下，能量输送区38a、38b可彼此极为接近地放置，并可接合组织区域。能量输送区38a可起到有源能量输送区的作用，能量输送区38b可起到返回路径的作用以完成电路。电流可从有源能量输送区38a流至返回能量输送区38b以将RF能量输送至靶组织区域。在一些情况下，也可考虑相反的配置，其中能量输送区38b可起到有源能量输送区的作用，能量输送区38a可起到返回路径的作用以完成电路。以类似的方式，第二双极对40b可起作用以将RF能量输送至靶组织。这种双极方式允许精确且有效的能量输送，并仅在必要的地方提供治疗。如将在下面更详细地讨论的，可以考虑，能量输送区38也可以以单极布置配置。在这种情况下，能量可在能量输送区38和定位在患者身体上的返回(或接地)电极20之间行进。
为了解释的目的，图2中仅示出两个双极对40a、40b。然而，任何合适数量的双极对40可设置在球囊26上以输送RF能量。例如，在球囊26上可以有一个、两个、三个、四个、五个、六个等双极对。根据需要，能量输送区38和/或双极对40可绕球囊26的周界和/或长度布置。在一些情况下，能量输送区38可沿球囊26的长度错开。在其他情况下，能量输送区38可定位在沿球囊26长度的相似位置处并绕球囊26的周界错开。在一些实施例中，能量输送区38可绕球囊26的周界均匀定位。在其他实施例中，能量输送区38可绕球囊26的周界不对称地定位。
电导线16的数量和配置可取决于能量输送区38的数量和配置，以及所设置的温度传感器42的数量，并可相应地变化。例如，电导线16可绕球囊26的周界定位，使得球囊26膨胀时能量输送区38位于绕诸如肾动脉的脉管的内表面的周界的位置处。应当理解，在如何将电导线16布置在细长杆22的外表面和/或球囊26上存在着许多改型。
在调制过程中，神经调制装置12可前进通过脉管系统直到球囊26定位在邻近期望的治疗区的位置处为止。随后，可使用膨胀流体使球囊26膨胀，使得球囊26的外表面32接触脉管壁或充分地紧密接近脉管壁。当球囊26处于膨胀状态时，设置在球囊26上的能量输送区38可接合或紧密接近邻近靶区的脉管壁。随后，电流可通过电导线16供给至能量输送区38以将治疗能量输送至靶区。应理解，功率控制单元18可控制电流的强度和/或治疗的持续时间以实现期望的毁损灶(lesion)大小。例如，通过有源能量输送区38，可形成1毫米(mm)至6mm大小的毁损灶。在一些情况下，能量输送区38可通过由功率控制元件18供给能量持续适当的时间长度而激活，如小于1分钟、1分钟、2分钟或多于2分钟。一旦在特定位置处完成了该程序，球囊26可部分或全部地收缩，然后细长杆22可移至不同的位置，如同一脉管的不同纵向位置或不同的脉管。随后，必要时，根据需要该程序可在相同位置或另一位置重复多次以实现期望的治疗。
图3示出另一神经调制装置50的远端部分。神经调制装置50在形式和功能上可类似于上述神经调制装置12。装置50可包括细长杆52、球囊56以及一个或多个设置在球囊56的外表面62上的电导线64。在一些实施例中，一个或多个温度传感器，如热敏电阻72a、72b(统称为72)可设置在球囊56的外表面62上。
细长杆52可从远端区域54向近侧延伸至配置成留在患者体外的近端。细长杆52的近端可包括附装其上用于连接其他治疗装置或提供便利其他治疗的端口的集线器。可以考虑，可修改细长杆52的刚性以形成用于脉管树中各种脉管直径以及各个位置的调制装置50。细长杆52可进一步包括一个或多个延伸通过其的腔。例如，细长杆52可包括导丝腔和/或一个或多个辅助腔。腔可以以本领域已知的任何方式配置。虽然未明确示出，调制装置50可进一步包括温度传感器/丝、输注腔、不透射线的标记带、固定的导丝末端、导丝腔、外部鞘套和/或其他组件以便利装置50在脉管系统中的使用和前进。
球囊56可具有近端区域58、远端区域60和用于接收膨胀流体的内部容积(未明确示出)。在一些实施例中，装置50可包括细长内杆(未示出)。球囊56的远端60可附接至内杆，近端区域58可附接至细长杆52，尽管这不是必需的。球囊56可通过激光定位、机械热结合、粘合剂、其他已知技术或以后开发的技术联接至装置。在其他实施例中，球囊56可形成为整体结构，固定地缚至或以其他方式联接至装置50。内杆可界定导丝腔，而在细长杆52和内杆之间的环形区域可界定膨胀腔。膨胀腔可界定用于膨胀流体进入的空间，在操作过程中该膨胀流体使球囊56膨胀。膨胀腔可连接至外部流体系统或贮存器(尽管未示出)以通过膨胀腔输送或输注流体至球囊56。外部流体系统可设置在能够使流体进入或以其他方式便利流体进入的任何位置上，如细长杆52的近端。在一些情况下，膨胀流体可使球囊56径向和/或纵向膨胀。
各具有近端区域(未示出)和远端区域66的一个或多个传导元件或电导线64可从细长杆52的近端区域延伸至球囊56。在一些情况下，电导线64可沿其至少一部分定位在细长杆52的腔内或杆壁上。在一些实施例中，电导线64的至少一部分可沿球囊56的外表面62延伸。可以考虑，电导线64可在细长杆52的腔内或杆壁上延伸，并可在球囊56联接至细长杆52的结合部55处从腔中退出。也可考虑其他构造。例如，电导线64可在沿装置50长度的任意点从内部位置过渡至外部位置，或者可沿其整个长度设置在装置50的外部。
电导线64可涂覆或以其他方式覆盖有绝缘体或绝缘材料65。在一些情况下，绝缘材料65的一部分可移除以界定一个或多个能量输送区68a、68b、68c、68d(统称为68)。电导线64形成能量输送区68的部分可以以任何期望的方式缠绕、盘绕或定位，诸如但不限于：蛇形、螺旋等。这可增加用于有效消融的能量输送区68的表面积。然而，这不是必需的。可以考虑，能量输送区68可以是电导线64的笔直区。
在一些实施例中，电导线64和能量输送区68可设置成以双极模式输送能量，其中能量在被紧密地一起放置在球囊56上的能量输送区68之间输送，无需外部接地极板。例如，能量输送区68可以以形成若干双极对的方式设置。在图3的实施例中，示出了第一双极对70a和第二双极对70b(统称为70)。第一双极对70a可由第一能量输送区68a和不同的第二能量输送区68b形成。第二双极对70b可由第三能量输送区68c和第四能量输送区68d形成。热敏电阻72a或其他温度感测装置可邻近能量输送区68a、68b放置，热敏电阻72b或其他温度感测装置可邻近能量输送区68c、68d放置以监测邻近能量输送区68的温度。在一些情况下，功率控制单元可基于邻近治疗区的温度控制能量的输送。如将在以下更详细地讨论的，可以考虑，能量输送区68也可以以单极布局配置。在这种情况下，能量可在能量输送区68与定位在患者身体上的返回(或接地)电极之间行进。
为了解释的目的，图3中仅示出两个双极对70a、70b。然而，任何合适数量的双极对70可设置在球囊56上以输送RF能量。例如，在球囊56上可有一个、两个、三个、四个、五个、六个等双极对。根据需要，能量输送区68和/或双极对70可绕球囊56的周界和/或长度布置。在一些情况下，能量输送区68可沿球囊56的长度错开。在其他情况下，能量输送区68可定位在沿球囊56长度的相似位置上并绕球囊56的周界错开。在一些实施例中，能量输送区68可绕球囊56的周界均匀定位。在其他实施例中，能量输送区68可绕球囊56的周界不对称地定位。
电导线64的数量和配置可取决于能量输送区68的数量和配置，以及所设置的温度传感器72的数量，并可相应地变化。例如，电导线64可绕球囊56的周界定位，使得球囊56膨胀时能量输送区68位于绕诸如肾动脉的脉管的内表面的周界的位置处。应当理解，在如何将电导线64布置在细长杆52的外表面和/或球囊56上存在着许多改型。
图4示出另一神经调制装置71的远端部分。神经调制装置71在形式和功能上可类似于上述神经调制装置12、50。装置71可包括细长杆73、球囊76以及一个或多个设置在球囊76的外表面82上的电导线84。在一些实施例中，一个或多个温度传感器，如热敏电阻92a、92b(统称为92)可设置在球囊76的外表面82上。虽然未明确示出，在一些情况下，温度传感器可以是热电偶。在这种情况下，可修改装置的布线以容纳热电偶。例如，热电偶可能需要独立的或滤过的、但非共享的接地路径。
细长杆73可从远端区域74向近侧延伸至配置成留在患者体外的近端。细长杆73的近端可包括附装其上用于连接其他治疗装置或提供便利其他治疗的端口的集线器。可以考虑，可修改细长杆73的刚性以形成用于脉管树中各种脉管直径以及各个位置的调制装置71。细长杆73可进一步包括一个或多个延伸通过其的腔。例如，细长杆73可包括导丝腔和/或一个或多个辅助腔。腔可以以本领域已知的任何方式配置。虽然未明确示出，调制装置71可进一步包括温度传感器/丝、输注腔、不透射线的标记带、固定的导丝末端、导丝腔、外部鞘套和/或其他组件以便利装置71在脉管系统中的使用和前进。
球囊76可具有近端区域78、远端区域80和用于接收膨胀流体的内部容积(未明确示出)。在一些实施例中，装置71可包括细长内杆(未示出)。球囊76的远端80可附接至内杆，近端区域78可附接至细长杆73，尽管这不是必需的。球囊76可通过激光定位、机械热结合、粘合剂、其他已知技术或以后开发的技术联接至装置。在其他实施例中，球囊76可形成为整体结构，固定地缚至或以其他方式联接至装置71。内杆可界定导丝腔，而在细长杆73和内杆之间的环形区域可界定膨胀腔。膨胀腔可界定用于膨胀流体进入的空间，在操作过程中该膨胀流体使球囊76膨胀。膨胀腔可连接至外部流体系统或贮存器(尽管未示出)以通过膨胀腔输送或输注流体至球囊76。外部流体系统可设置在能够使流体进入或以其他方式便利流体进入的任何位置上，如细长杆73的近端。在一些情况下，膨胀流体可使球囊76径向和/或纵向膨胀。
各具有近端区域(未示出)和远端区域86的一个或多个传导元件或电导线84可从细长杆73的近端区域延伸至球囊76。在一些情况下，电导线84可沿球囊86的外表面82以及细长杆73的外表面延伸，尽管这并不是必需的。在其他情况下，电导线84可沿其至少一部分定位在细长杆73的腔内或杆壁上。在一些实施例中，电导线84的至少一部分可沿球囊76的外表面82延伸。也可考虑其他配置。电导线84可涂覆或以其他方式覆盖有绝缘体或绝缘材料85。
在一些实施例中，电导线84中一些的远端区域86可连接至一个或多个电极88a、88b、88c、88d(统称为88)。电极88可以是粘接至球囊76的外表面82并连接至电导线84的离散元件。在一些情况下，电极88可以锡焊(solder)、焊接(weld)、钎焊(braze)等至电导线。可以考虑，电极88可由能够将RF能量输送至靶组织的任何材料制成。虽然电极88示为具有大体椭圆的形状，可以考虑，电极88可采用期望的任何形状，诸如但不限于方形、圆形、矩形、多边形等。
在一些实施例中，电导线84和电极88可设置成以双极模式输送能量，其中能量在被一起紧放在球囊76上的电极88之间输送，且无需外部接地极板。例如，电极88可以以形成若干双极对的方式布置。在图4的实施例中，示出了第一双极对90a和第二双极对90b(统称为90)。第一双极对90a可由第一电极88a和不同的第二电极88b形成。第二双极对90b可由第三电极88c和第四电极88d形成。热敏电阻92a或其他温度感测装置可邻近电极88a、88b放置，热敏电阻92b或其他温度感测装置可邻近电极88c、88d放置以监测邻近电极88的温度。在一些情况下，功率控制单元可基于邻近治疗区的温度控制能量的输送。如将在下面更详细地讨论的，可以考虑，电极88也可按单极布局配置。在这种情况下，能量可在电极88和定位在患者身体上的返回(或接地)电极之间行进。
为了解释的目的，图4中仅示出两个双极对90a、90b。然而，任何合适数量的双极对90可设置在球囊76上以输送RF能量。例如，在球囊76上可有一个、两个、三个、四个、五个、六个等双极对。根据需要，电极88和/或双极对90可绕球囊76的周界和/或长度布置。在一些情况下，电极88可沿球囊76的长度错开。在其他情况下，电极88可定位在沿球囊76长度的相似位置上并绕球囊76的周界错开。在一些实施例中，电极88可绕球囊76的周界均匀定位。在其他实施例中，电极88可绕球囊76的周界不对称地定位。
电导线84的数量和配置可取决于电极88的数量和配置，以及所设置的温度传感器92的数量，并可相应地变化。例如，电导线84可绕球囊76的周界定位，使得球囊76膨胀时电极88位于绕诸如肾动脉的脉管的内表面的周界的位置处。应当理解，在如何将电导线84布置在细长杆73的外表面和/或球囊76上存在着许多改型。
图5示出另一神经调制装置100的远端部分。神经调制装置100在形式和功能上可类似于上述神经调制装置12、50、71。装置100可包括细长杆102、球囊106以及一个或多个设置在球囊106的外表面142上的电导线114。在一些实施例中，一个或多个温度传感器，如热敏电阻122可设置在球囊106的外表面112上。虽然未明确示出，在一些情况下，温度传感器可以是热电偶。在这种情况下，可修改装置的布线以容纳热电偶。例如，热电偶可能需要独立的或滤过的、但非共享的接地路径。
细长杆102可从远端区域104向近侧延伸至配置成留在患者体外的近端。细长杆102的近端可包括附装其上用于连接其他治疗装置或提供便利其他治疗的端口的集线器。可以考虑，可修改细长杆102的刚性以形成用于脉管树中各种脉管直径以及各个位置的调制装置100。细长杆102可进一步包括一个或多个延伸通过其的腔。例如，细长杆102可包括导丝腔和/或一个或多个辅助腔。腔可以以本领域已知的任何方式配置。虽然未明确示出，调制装置100可进一步包括温度传感器/丝、输注腔、不透射线的标记带、固定的导丝末端、导丝腔、外部鞘套和/或其他组件以便利装置100在脉管系统中的使用和前进。
球囊106可具有近端区域108、远端区域110和用于接收膨胀流体的内部容积(未明确示出)。在一些实施例中，装置100可包括细长内杆(未示出)。球囊106的远端110可附接至内杆，近端区域108可附接至细长杆102，尽管这不是必需的。球囊106可通过激光定位、机械热结合、粘合剂、其他已知技术或以后开发的技术联接至装置。在其他实施例中，球囊106可形成为整体结构，固定地缚至或以其他方式联接至装置100。内杆可界定导丝腔，而在细长杆102和内杆之间的环形区域可界定膨胀腔。膨胀腔可界定用于膨胀流体进入的空间，在操作过程中该膨胀流体使球囊106膨胀。膨胀腔可连接至外部流体系统或贮存器(尽管未示出)以通过膨胀腔输送或输注流体至球囊106。外部流体系统可设置在能够使流体进入或以其他方式便利流体进入的任何位置上，如细长杆102的近端。在一些情况下，膨胀流体可使球囊106径向和/或纵向膨胀。
各具有近端区域(未示出)和远端区域116的一个或多个传导元件或电导线114可从细长杆102的近端区域延伸至球囊106。在一些情况下，电导线114可沿球囊86的外表面112以及细长杆102的外表面延伸，尽管这并不是必需的。在其他情况下，电导线114可沿其至少一部分定位在细长杆102的腔内或杆壁上。在一些实施例中，电导线114的至少一部分可沿球囊106的外表面112延伸。也可考虑其他配置。
电导线114可涂覆或以其他方式覆盖有绝缘体或绝缘材料115。在一些情况下，绝缘材料115的一部分可移除以界定一个或多个能量输送区118。电导线114形成能量输送部分118的部分可以以期望的任何方式缠绕、盘绕或定位，诸如但不限于蛇形、螺旋等。这可增加用于有效消融的能量输送部分118的表面积。然而，这不是必需的。可以考虑，能量输送部分118可以是电导线114的笔直区。在一些实施例中，能量输送部分118可以是粘接至电导线114的远端区域116的离散电极。
在一些实施例中，电导线114和能量输送区118可设置成以双极模式输送能量，其中能量在能量输送区118与外部接地极板(如图1中示出的接地极板20)之间输送。热敏电阻122或其他温度感测装置可邻近能量输送区118放置以监测邻近能量输送区118的温度。在一些情况下，功率控制单元可基于邻近治疗区的温度控制能量的输送。可以考虑，能量输送区118也可以单极布局配置。在这种情况下，能量可在相邻的能量输送区118之间行进。
为了解释的目的，图5中仅示出两个能量输送区118。然而，任何合适数量的能量输送区118可设置在球囊106上以输送RF能量。例如，在球囊106上可有一个、两个、三个、四个、五个、六个等能量输送区118。根据需要，能量输送区118可绕球囊106的周界和/或长度布置。在一些情况下，能量输送区118可沿球囊106的长度错开。在其他情况下，能量输送区118可定位在沿球囊106长度的相似位置上并绕球囊106的周界错开。在一些实施例中，能量输送区118可绕球囊106的周界均匀定位。在其他实施例中，能量输送区118可绕球囊106的周界不对称地定位。
电导线114的数量和配置可取决于能量输送区118的数量和配置，以及所设置的温度传感器122的数量，并可相应地变化。例如，电导线114可绕球囊106的周界定位，使得球囊106膨胀时能量输送区118位于绕诸如肾动脉的脉管的内表面的周界的位置处。应当理解，在如何将电导线114布置在细长杆102的外表面和/或球囊106上存在着许多改型。
图6示出另一神经调制装置130的远端部分。神经调制装置130在形式和功能上可类似于上述神经调制装置12、50、71、100。装置130可包括细长杆132、球囊136以及一个或多个设置在球囊136的外表面142上的电导线144、147。在一些实施例中，一个或多个温度传感器，如热敏电阻150可设置在球囊136的外表面142上。虽然未明确示出，在一些情况下，温度传感器可以是热电偶。在这种情况下，可修改装置的布线以容纳热电偶。例如，热电偶可能需要独立的或滤过的、但非共享的接地路径。
细长杆132可从远端区域134向近侧延伸至配置成留在患者体外的近端。细长杆132的近端可包括附装其上用于连接其他治疗装置或提供便利其他治疗的端口的集线器。可以考虑，可修改细长杆132的刚性以形成用于脉管树中各种脉管直径以及各个位置的调制装置130。细长杆132可进一步包括一个或多个延伸通过其的腔。例如，细长杆132可包括导丝腔和/或一个或多个辅助腔。腔可以以本领域已知的任何方式配置。虽然未明确示出，调制装置130可进一步包括温度传感器/丝、输注腔、不透射线的标记带、固定的导丝末端、导丝腔、外部鞘套和/或其他组件以便利装置130在脉管系统中的使用和前进。
球囊136可具有近端区域138、远端区域140和用于接收膨胀流体的内部容积(未明确示出)。在一些实施例中，装置130可包括细长内杆(未示出)。球囊136的远端140可附接至内杆，而近端区域138可附接至细长杆132，尽管这不是必需的。球囊136可通过激光定位、机械热结合、粘合剂、其他已知技术或以后开发的技术联接至装置。在其他实施例中，球囊136可形成为整体结构，固定地缚至或以其他方式联接至装置130。内杆可界定导丝腔，而在细长杆132和内杆之间的环形区域可界定膨胀腔。膨胀腔可界定用于膨胀流体进入的空间，在操作过程中该膨胀流体使球囊136膨胀。膨胀腔可连接至外部流体系统或贮存器(尽管未示出)以通过膨胀腔输送或输注流体至球囊136。外部流体系统可设置在能够使流体进入或以其他方式便利流体进入的任何位置上，如细长杆132的近端。在一些情况下，膨胀流体可使球囊136径向和/或纵向膨胀。
各具有近端区域(未示出)和远端区域146的一个或多个传导元件或电导线144可从细长杆132的近端区域延伸至球囊136。在一些情况下，电导线144可沿球囊136的外表面142以及细长杆132的外表面延伸，尽管这并不是必需的。在其他情况下，电导线144可沿其至少一部分定位在细长杆132的腔内或杆壁上。在一些实施例中，电导线144的至少一部分可沿球囊136的外表面142延伸。也可考虑其他配置。电导线144可涂覆或以其他方式覆盖有绝缘体或绝缘材料145。
在一些实施例中，电导线114中一些的远端区域146可连接至一个或多个微电阻148a、148b、148c、148d(统称为148)。第一电导线144可连接至第一微电阻148a。第一微电阻148a可通过第二电导线147连接至第二微电阻148b。电导线147可涂敷或以其他方式覆盖有绝缘体或绝缘材料。电导线147可串联连接一对微电阻148a、148b。电流可通过第二微电阻148b输送至第一微电阻148a并返回至功率单元。电流行进通过微电阻148a、148b时，微电阻148可产生用来调制靶组织的热。在一些情况下，微电阻148a、148b可配置为单个微电阻，其具有一定大小并形成为在温度感测元件150的两个或两个以上侧面周围延伸。微电阻148c、148d可以以类似于微电阻148a、148b的方式配置。
虽然微电阻148表示为具有矩形形状，可以考虑，微电阻148可采取任何已知微电阻的大小和形状。进一步可以考虑，微电阻148可采取其他加热元件的形式。热敏电阻150或其他温度感测装置可邻近微电阻148放置以监测邻近微电阻148的温度。在一些情况下，功率控制单元可基于邻近治疗区的温度控制能量的输送。
为了解释的目的，图6中仅示出四个微电阻148。然而，任何合适数量的微电阻148可设置在球囊136上以输送调制能量。例如，在球囊136上可有一个、两个、三个、四个、五个、六个等微电阻148。根据需要，微电阻148可绕球囊136的周界和/或长度布置。在一些情况下，微电阻148可沿球囊136的长度错开。在其他情况下，微电阻148可定位在沿球囊136长度的相似位置上并绕球囊136的周界错开。在一些实施例中，微电阻148可绕球囊136的周界均匀定位。在其他实施例中，微电阻148可绕球囊136的周界不对称地定位。
电导线144、147的数量和配置可取决于微电阻148的数量和配置，以及所设置的温度传感器150的数量，并可相应地变化。例如，电导线144可绕球囊136的周界定位，使得球囊136膨胀时微电阻148位于绕诸如肾动脉的脉管的内表面的周界的位置处。应当理解，在如何将电导线144布置在细长杆132和/或球囊136的外表面上存在着许多改型。
图7示出另一神经调制装置200的远端部分。神经调制装置200在形式和功能上可类似于上述神经调制装置12、50、71、100、130。装置200可包括细长杆202和邻近细长杆202的远端区域206的球囊204。柔性衬底208可设置在球囊206上。细长杆202可从远端区域206向近侧延伸至配置成留在患者体外的近端。细长杆202的近端可包括附装其上用于连接其他治疗装置或提供便利其他治疗的端口的集线器。可以考虑，可修改细长杆202的刚性以形成用于脉管树中各种脉管直径以及各个位置的调制装置200。细长杆202可进一步包括一个或多个延伸通过其的腔。例如，细长杆202可包括导丝腔和/或一个或多个辅助腔。腔可以以本领域已知的任何方式配置。虽然未明确示出，调制装置200可进一步包括温度传感器/丝、输注腔、不透射线的标记带、固定的导丝末端、导丝腔、外部鞘套和/或其他组件以便利装置200在脉管系统中的使用和前进。
球囊204可具有近端区域210、远端区域212和用于接收膨胀流体的内部容积(未明确示出)。在一些实施例中，球囊26可由顺应性材料制成，诸如但不限于聚氨酯。在一些情况下，顺应性球囊可具有比非顺应性球囊低的轮廓。在一些实施例中，装置200可包括细长内杆(未示出)。球囊204的远端212可附接至内杆，而近端区域210可附接至细长杆202，尽管这不是必需的。球囊204可通过激光定位、机械热结合、粘合剂、其他已知技术或以后开发的技术联接至装置。在其他实施例中，球囊204可形成为整体结构，固定地缚至或以其他方式联接至装置200。内杆可界定导丝腔，而在细长杆202和内杆之间的环形区域可界定膨胀腔。膨胀腔可界定用于膨胀流体进入的空间，在操作过程中该膨胀流体使球囊204膨胀。膨胀腔可连接至外部流体系统或贮存器(尽管未示出)以通过膨胀腔输送或输注流体至球囊204。外部流体系统可设置在能够使流体进入或以其他方式便利流体进入的任何位置上，如细长杆202的近端。在一些情况下，膨胀流体可使球囊204径向和/或纵向膨胀。
各具有近端区域(未示出)和远端区域216的一个或多个传导元件或电导线214可从细长杆202的近端区域延伸至球囊204。在一些情况下，电导线214可结合至柔性衬底208，柔性衬底208附装至球囊204的外表面。柔性衬底208可由顺应性材料制成，诸如但不限于聚氨酯。在一些情况下，柔性衬底208可以是管状元件，其可在球囊上热收缩、扩张，或者以其他方式附装至球囊204。可以考虑，电导线214可粘接至管状柔性衬底的外径，尽管这并不是必须的。在其他实施例中，柔性衬底208可以是环绕球囊204外表面216的平板，其结合至本身和/或球囊204。可以考虑，电导线214可粘接至平板的内表面或外表面。电导线214可沿球囊204以及细长杆202的外表面延伸，尽管这并不是必需的。在其他情况下，电导线214可沿其至少一部分定位在细长杆202的腔内或杆壁上。在一些实施例中，电导线214的至少一部分可沿球囊204的外表面216延伸。也可考虑其他配置。电导线214可涂覆或以其他方式覆盖有绝缘体或绝缘材料218。在一些情况下，电导线214可以以缠绕或蛇形的方式结合至柔性衬底208以允许球囊204扩张或伸展，而不会使电导线214断裂。
在一些实施例中，电导线214中一些的远端区域216可连接至一个或多个电极220a、220b、220c、220d(统称为220)。电极220可以是粘接至柔性衬底208并连接至电导线214的离散元件。在一些情况下，电极220可锡焊、焊接、钎焊等至电导线。可以考虑，电极220可由能够输送RF能量至靶组织的任何材料制成。虽然电极220示出为具有大体椭圆形，可以考虑，电极220可采用期望的任何形状，诸如但不限于：方形、圆形、矩形、多边形等。可以考虑，在一些情况下，电极220可由电导线的导电区域形成。
在一些实施例中，电导线214和电极220可设置成以双极模式输送能量，其中能量在被紧放在一起的电极220之间输送，且无需外部接地极板。例如，电极220可以以形成若干双极对的方式布置。在图7的实施例中，示出了第一双极对222a和第二双极对222b(统称为222)。第一双极对222a可由第一电极220a和不同的第二电极220b形成。第二双极对222b可由第三电极220c和第四电极220d形成。热敏电阻224a或其他温度感测装置可邻近电极220a、220b放置，热敏电阻224b或其他温度感测装置可邻近电极220c、220d放置以监测邻近电极220的温度。虽然未明确示出，在一下情况下，温度传感器可以是热电偶。在这种情况下，可修改装置的布线以容纳热电偶。例如，热电偶可能需要独立的或滤过的、但非共享的接地路径。在一些情况下，功率控制单元可基于邻近治疗区的温度控制能量的输送。如将在下面更详细地讨论的，可以考虑，电极220也可按单极布局配置。在这种情况下，能量可在电极220和定位在患者身体上的返回(或接地)电极之间行进。
为了解释的目的，图7中仅示出两个双极对222a、222b。然而，任何合适数量的双极对222可设置在球囊204上以输送RF能量。例如，在球囊204上可有一个、两个、三个、四个、五个、六个等双极对。根据需要，电极220和/或双极对222可绕球囊204的周界和/或长度布置。在一些情况下，电极220可沿球囊204的长度错开。在其他情况下，电极220可定位在沿球囊204长度的相似位置上并绕球囊204的周界错开。在一些实施例中，电极220可绕球囊204的周界均匀定位。在其他实施例中，电极220可绕球囊204的周界不对称地定位。
电导线214的数量和配置可取决于电极220的数量和配置，以及所设置的温度传感器224的数量，并可相应地变化。例如，电导线214可绕球囊204的周界定位，使得球囊204膨胀时电极220位于绕诸如肾动脉的脉管的内表面的周界的位置处。应当理解，在如何将电导线214布置在细长杆202的外表面和/或球囊204上存在着许多改型。
装置12、50、71、100、130、200的一些部分可由金属，金属合金，聚合物(下文公开了其一些示范例)，金属-聚合物复合物，陶瓷，及其组合等，或者其他合适的材料。合适的金属和金属合金的一些示范例包括诸如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。
在一些实施例中，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。
在一些实施例中，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。
在至少一些实施例中，所有装置12、50、70、100、130、200或其中的一些部分也可掺杂有，材料为，或包括不透射线的材料。不透射线的材料通常理解为在跨越x射线到伽马射线(厚度小于0.005)的波长范围内对RF能量不透明的材料。这些材料在荧光镜屏幕上能够产生相对较暗的图像，而诸如组织的不透射线的材料产生相对较亮的图像。这个相对较亮的图像可帮助装置12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/或线圈也可包括在装置12、50、71、100、130、200的设计中以实现相同的结果。
在一些实施例中，给予装置12、50、71、100、130一定程度的磁共振成像(MRI)兼容性。例如，装置12、50、71、100、130、200或其一些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。装置12、50、71、100、130、200或其一些部分也可由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。
装置12、50、71、100、130、200的合适的聚合物的一些示范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(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，)，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SIBS50A)，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。
本领域技术人员应理解，除了本文中描述和考虑的具体实施方式之外，本发明主题可以以多种形式做出修改。于是，在不超出本发明范围和实质的前提下，可在形式和细节上做出变化。

Claims (15)

1.一种用于神经调制和/或消融的血管内器械，所述血管内器械包括：
具有近端区域、远端区域和在其之间延伸的腔的细长杆；
联接至所述细长杆的所述远端区域的可膨胀球囊；
从所述近端区域延伸至所述可膨胀球囊的一个或多个电导线，所述一个或多个电导线具有直接缚至所述可膨胀球囊的外表面的远端区域；以及定位在所述可膨胀球囊上并联接至所述一个或多个电导线的一个或多个能量输送区；
其中所述一个或多个能量输送区由所述一个或多个电导线的远侧部分形成；
其中所述一个或多个能量输送区由不含绝缘体的所述一个或多个电导线的一些区域界定；
其中不含绝缘体的所述一个或多个电导线的至少一部分以蛇形方式缠绕。
2.根据权利要求1所述的血管内器械，其中所述一个或多个电导线沿所述细长杆的外表面和所述可膨胀球囊的外表面延伸。
3.根据权利要求1所述的血管内器械，其中所述一个或多个电导线沿所述细长杆的长度的至少一部分和所述可膨胀球囊的外表面在所述细长杆的所述腔内延伸。
4.根据权利要求1所述的血管内器械，其中所述一个或多个电导线中的每一个至少部分地涂覆有绝缘体。
5.根据权利要求4所述的血管内器械，其中所述绝缘体包括聚对苯二甲酸乙二醇酯(PET)、聚酰胺、聚酯、聚氨酯、含氟聚合物或聚酰亚胺。
6.根据权利要求1所述的血管内器械，其中所述一个或多个电导线中的每一个具有大体圆形的横截面。
7.根据权利要求1所述的血管内器械，其中所述一个或多个电导线中的每一个具有大体矩形的横截面。
8.根据权利要求1所述的血管内器械，其中所述一个或多个能量输送区包括射频电极。
9.根据权利要求1所述的血管内器械，其中所述一个或多个能量输送区包括一个或多个加热元件。
10.根据权利要求1-9中任一所述的血管内器械，还包括一个或多个温度传感器。
11.根据权利要求10所述的血管内器械，其中所述一个或多个温度传感器包括热敏电阻。
12.根据权利要求1-9中任一所述的血管内器械，其中所述一个或多个能量输送区包括双极对。
13.根据权利要求1-9中任一所述的血管内器械，其中所述可膨胀球囊由非顺应性材料形成。
14.根据权利要求1-9中任一所述的血管内器械，其中不含绝缘体的所述一个或多个电导线的至少一部分以蛇形方式沿所述可膨胀球囊纵向缠绕。
15.根据权利要求1-9中任一所述的血管内器械，其中所述器械是配置成用于肾神经调制和/或消融的血管内器械。
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