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CN101972513B - 肾神经调节的方法和装置 - Google Patents

肾神经调节的方法和装置 Download PDF

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CN101972513B
CN101972513B CN 201010279054 CN201010279054A CN101972513B CN 101972513 B CN101972513 B CN 101972513B CN 201010279054 CN201010279054 CN 201010279054 CN 201010279054 A CN201010279054 A CN 201010279054A CN 101972513 B CN101972513 B CN 101972513B
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CN 201010279054
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CN101972513A (zh )
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马克·迪姆
汉森·吉尔福德·三世
丹尼斯·德马雷
道格拉斯·萨顿
埃里克·塔尔
马克·盖尔劳德
霍华德·R·莱文
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美敦力Af卢森堡有限责任公司
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Abstract

本发明提供了用于肾神经调节的方法和装置，其使用脉冲电场进行电穿孔或电融合。除了别的以外，预计肾神经调节作用(例如，去除神经作用)可以减少急性心肌梗塞的扩张，减少或防止与充血性心力衰竭相关的形态学变化的发作，和/或有效用于肾病晚期的治疗。本发明的实施方案设置成经皮血管内输送脉冲电场以实现这样的神经调节作用。

Description

肾神经调节的方法和装置

[0001] 相关申请的交叉参考

[0002] 本申请要求于2004年10月5日提交的美国临时专利申请序列号60/616,254,和于 2004年11月2日提交的序列号60/624，793的提出日的利益;二者通过参考完全结合于此。此 夕卜，本申请是于2003年4月8日提交的同时待审的美国专利申请序列号10/408，665的部分继 续申请，所述申请在2003年11月20日公布为美国专利申请2003/0216792，并且其要求于 2002年4月8日提交的美国临时专利申请序列号60/370,190,于2002年10月3日提交的序列 号60/415，575，和于2003年1月29日提交的序列号60/442，970的提出日的利益;所有这些临 时申请通过参考完全结合于此。

[0003] 参考文献的结合

[0004] 本说明书中提及的所有出版物和专利申请通过参考以相同的程度并入本申请，就 象每一单独的出版物或专利申请具体地并且独立地结合而作为参考。

技术领域

[0005] 本发明涉及肾神经调节的方法和装置。更具体地，本发明涉及通过脉冲电场和/或 电穿孔或电融合获得肾神经调节的方法和装置。

[0006] 背景

[0007] 充血性心力衰竭（“CHF”）是当心脏受到损伤并且减少供应机体器官的血流时发生 的一种病症。如果血流充分减少，那么肾功能将受到损害，并且导致流体滞留、异常的激素 分泌和增加的血管收缩。这些结果增加了心脏的负担，并且进一步减少心脏通过肾和循环 系统栗血的能力。

[0008] 这种减少的能力进一步减少流向肾脏的血液，其又进一步减少心脏的能力。据信， 肾脏的逐渐减少的灌注是使得CHF下行螺旋永续的主要非心脏因素。此外，流体负担和由这 些生理变化导致的相关临床症状是由于CHF引起的过多的入院、很坏的生活质量和卫生保 健系统的过重的成本的主要因素。

[0009] 尽管起初有许多不同的疾病可以损伤心脏，但是一旦存在，CHF分成两种类型：慢 性CHF和急性(或代偿失调-慢性)CHF。慢性充血性心力衰竭是一种长期的、缓慢发展的变性 疾病。几年后，慢性充血性心力衰竭导致心机能不全。慢性CHF临床上由患者锻炼或者进行 正常的日常生活活动的能力（诸如由New York Heart Association Functional Class定 义的那样)而分类。慢性CHF患者通常基于门诊典型地用药进行应付。

[0010] 慢性CHF患者可能经历心脏功能的突发的严重退化，叫作急性充血性心力衰竭，这 导致心脏没有能力维持充足的血流和压力来保持机体重要器宫的存活。在稳定的慢性CHF 患者中，当额外的压力(诸如感染或过多的流体负担）显著地增加心脏负担时，可能发生这 些急性CHF退化。与慢性CHF的逐步的下行发展相反，患有急性CHF的患者可能从甚至是CHF 的最早阶段退化到严重的血液动力崩溃。另外，急性CHF可以在急性心肌梗塞（“AMI”）后的 几个小时或几天内发生，所述急性心肌梗塞是对于心肌的突发的、不可复原的损伤，通常叫 作心脏病发作。

[0011] 如提及的那样，肾脏在CHF的发展中，以及在慢性肾衰竭（“CRF”）、晚期肾病 (“ESRD”）、高血压(疾病引起的高血压）以及其它心-肾疾病中起着重要作用。肾脏功能可以 在3个主要方面进行总结:滤过血液并且排泄机体新陈代谢产生的废物;调控盐、水、电解质 和酸碱平衡;并且分泌激素维持重要器官的血流。没有正确行使功能的肾脏，那么患者将患 有水滞留，减少的尿流，并且在血液和机体内累积废物毒素。据信，由减少的肾功能或肾衰 竭(肾衰)导致的这些病症增加心脏负担。在CHF患者中，由于弱功能性肾脏引起的水的积聚 和血液毒素累积，肾衰竭将引起心脏进一步退化，并且又将引起心脏进一步损坏。

[0012] 肾脏参与尿形成的主要功能单位叫作“肾单位”。每个肾由大约一百万个肾单位组 成。肾单位由肾小球及其肾小管组成，肾小管可以分成许多部分:近端小管，髓襻(亨利袢） 和远端小管。每个肾单位由不同类型的细胞围绕，所述细胞具有分泌一些物质和激素(诸如 肾素和促红细胞生成素）的能力。尿的形成是从将血浆水分滤过到肾小球中起始的复杂的 过程的结果。肾小球的壁对于水和小分子是自由通透的，而对于蛋白和大分子几乎不可通 透。因此，在健康的肾脏中，滤过物几乎没有蛋白，并且没有细胞成分。最后变成尿的滤过的 流体流过导管。尿的最后的化学组成由尿保持动态平衡所需要的物质的分泌和重吸收而确 定。

[0013] 接收大约20%的心脏输出，两个肾脏每分钟过滤大约125ml的血浆水。滤过由于跨 越肾小球膜的压力梯度而发生。肾脏动脉中的压力推动血浆水穿过肾小球，而引起滤过。为 了保持肾小球滤过速率（“GFR”）相对稳定，肾小球的压力通过传入和传出微动脉的收缩或 扩张而保持恒定，所述传入和传出微动脉的肌肉壁管进出每个肾小球。

[0014] 在CHF患者中，心脏日益衰竭，并且在患者的循环系统中血流和压力将下降。在急 性心力衰竭中，短期补偿提供保持主要器宫灌注的作用，特别是保持长期缺少血流不能存 活的大脑和心脏的灌注。然而，这些最初在急性心力衰竭中辅助存活的相同的反应在慢性 心力衰竭过程中是有害的。

[0015] 复杂机制的组合构成CHF中有害的流体超负荷。由于心脏衰竭和血压下降，肾脏不 能行使功能，并且由于不足的灌注血压而受到损害。肾功能的这种损害最终导致尿输出量 的减少。没有充分的尿输出，机体保留流体，并且在患者中其它的不理想病症中，所引起的 流体超负荷引起末梢水肿(腿的水肿）、呼吸短缺（由于肺部的流体）、和腹部流体滞留。

[0016] 另外，心脏输出的减少导致减少的肾脏血流，增加的神经激素刺激，并且从肾脏的 肾小球旁器释放激素肾素。这导致钠的急剧滞留，并且因此导致体积膨胀。增加的肾素导致 形成血管紧张素，一种有效的血管收缩剂。心力衰竭和引起的血压减少还减少通过除肾脏 外的机体器官的血流和灌注压。由于它们遭受减少的血压，这些器官可能缺氧，引起代谢性 酸中毒，这减少药物治疗的效力并且增加突发死亡的危险。

[0017] 据信，医生在心力衰竭患者中观察到的退化的这种螺旋至少部分受到心脏功能和 肾脏功能之间的微细相互作用的激活的调控，所述相互作用叫作肾素-血管紧张素系统。心 脏栗血功能的干扰导致减少的心脏输出和减少的血流。肾脏响应减少的血流就好像总的血 液体积减少了一样，实际上此时检测的体积是正常的或者甚至是增加的。这引起肾脏的流 体滞留，并且形成水肿，因而引起流体超负荷和关于心脏的增加的压力。

[0018] 系统地，CHF与异常升高的外周血管阻力相关，并且受到由于交感神经系统功能的 强烈干扰引起的循环改变的控制。增加的交感神经系统活性促进这样的恶性循环，即，增加 的动脉血管收缩(增加的血管对血流的阻力），然后进一步减少心脏输出，这引起更多减少 的流向重要器官的血液。

[0019] 在先前通过血管收缩机制解释的CHF中，心脏和循环系统显著地减少流向肾脏的 血液。在CHF过程中，肾脏通过神经途径和激素信使从高级神经中枢得到命令，保留机体内 的流体和钠。应答对于心脏的压力，神经中枢命令肾脏减少它们的滤过功能。尽管在短期 内，这些命令可能是有利的，如果这些命令持续几个小时和几天，它们可能通过使得肾脏停 止起作用而危害个体的生命，或者使得个体依赖人工肾脏维持生命。

[0020] 当肾脏不完全过滤血液时，大量的流体滞留在机体内，这导致肿胀(组织中流体滞 留），并且增加心脏负担。流体可以透到肺部，并且患者变得呼吸短缺。这种奇怪的和自我-破坏性现象最可能由机体的正常补偿机制而解释，所述机体错误地将CHF的慢性的缓慢血 压感知为临时干扰诸如流血的征兆。

[0021] 在急性情形中，机体尝试保护其最重要的器官，脑和心脏，免受氧气匮乏的危险。 命令通过神经和激素途径和信使传出。这些命令针对维持脑和心脏的血压的目的，脑和心 脏由机体视为最重要的器官。脑和心脏不能持续低灌注任何基本的时间阶段。如果这些器 官的血压减少到不可接受的水平，那么将引起中风或心搏停止。其它的器官，诸如肾脏，可 以经受稍微长期的缺血而不会遭受长期的损害。因此，为了支持脑和心脏，机体牺牲对这些 其它器官的血液供应。

[0022] CHF引起的血液动力学损害激活一些神经激素系统，诸如肾素-血管紧张素和醛固 酮系统、交感-肾上腺系统和血管升压素的释放。由于肾脏遭受增加的肾血管收缩，所以GFR 下降，并且循环系统中钠的负荷增加。同时，更多的肾素从肾脏的近肾小球释放。减少的肾 功能的组合作用包括减少的肾小球钠负荷，醛固酮-介导的钠管式重吸收的增加，以及钠和 水分在机体内的滞留。这些作用导致一些CHF病症的迹象和症状，包括扩大的心脏、增加的 收缩壁压、增加的心肌氧需求、以及基于流体和钠在肾脏中的滞留形成水肿。因此，持续减 少的肾血流和血管收缩是引起与CHF相关的流体滞留的直接原因。

[0023] CHF是日益加重的，并且到目前还是不可治愈的。药物治疗的局限及其没有能力逆 转或者甚至是阻止CHF患者的恶化是显而易见的。在一些情形中，手术治疗是有效的，但是 由于相关的危险和费用，仅限于末期患者群体。此外，肾脏在CHF患者恶化中的显著作用不 能由目前的手术治疗充分地阐明。

[0024] 自主神经系统被视作重要的信号控制途径，其负责调控对于维持血管流体平衡和 血压重要的机体功能。自主神经系统以信号的形式将来自机体生物传感器诸如压力感受器 (应答压力和血液体积)和化学感受器(应答血液的化学组合物）的信息通过其感觉纤维传 导到中枢神经系统。它还通过其运动纤维传导来自中枢神经系统的命令信号，所述命令信 号控制血管系统的受神经支配的各种成分。

[0025] 关于人肾脏植入的经验提供了关于神经系统在肾脏功能中的作用的早期证据。注 意到，植入后，当所有的肾脏神经完全起作用时，肾脏增加水和钠的排泄。当肾神经被切断 或者化学破坏时，这一现象也在动物中观察到。由于去神经对肾脏的作用类似于利尿药物， 所以，所述现象叫作“去神经利尿”。后来，发现“去神经利尿”与导致通过肾脏的增加的血流 的肾动脉系统的血管舒张相关。这一观察得到在动物中下述观察的证实:减少的供应肾脏 的血压逆转了“去神经利尿”。

[0026] 还观察到，在成功病例植入手术过后的几个月后，植入受体的“去神经利尿”停止， 并且肾功能恢复正常。最初，据信，“肾利尿”是暂时现象，并且将来自中枢神经系统的信号 传导至肾脏的神经对于肾脏功能是不重要的。后来的发现表明，肾神经具有深刻的再生能 力，并且“去神经利尿”的逆转可能归因于为肾脏提供必需的刺激的新的神经纤维的生长。

[0027] 另一个研究团体集中在肾脏对激素肾素分泌的神经控制上。如先前所讨论的那 样，肾素是负责心力衰竭患者中血管收缩和水与钠滞留的“恶性循环”的激素。证明肾交感 神经活性的增加或减少分别在肾脏分泌肾素的速率中产生相应的增加和减少。

[0028] 概括来说，从临床经验和大的动物研究团体可知，肾交感神经活性的增加导致供 应肾脏的血管的血管收缩、减少的肾血流、减少的水和钠从机体的去除、以及增加的肾素分 泌。还可知肾交感神经活性的减少，例如，通过去神经作用，可以逆转这些作用。

[0029] 已经在动物模型中确定，心力衰竭病症导致肾脏异常高的交感刺激。这一现象追 溯到将来自压力感受器的信号传导到中枢神经系统的感受神经。压力感受器存在于血管系 统的不同位置。在颈动脉(为脑提供动脉血)的压力感受器和针对肾脏的交感神经刺激之间 存在强有力的关系。当在患有心力衰竭的实验动物中，动脉血压力突然减小时，交感紧张增 加。然而，在慢性CHF患者中，正常的压力反射可能不完全负责升高的肾神经活性。如果暴露 于减少的动脉压力水平一段延长的时间，那么压力感受器通常“重新调定”，即，恢复到基线 活性水平，直到引入新的干扰。因此，据信，在慢性CHF患者中，负责控制血压和肾脏功能神 经控制的自主神经系统成分变得异常。虽然引起这种异常的准确机制没有得到充分理解， 但是它对CHF患者综合病症的作用是深刻地阴性的。

[0030] 晚期肾脏疾病(End-Stage Renal Disease)是至少部分由肾神经活性控制的另一 种病症。由于糖尿病性肾病、慢性肾小球肾炎和不可控制的高血压，在患有ESRD的患者中存 在显著的增加。慢性肾衰竭缓慢地发展成ESRDXRF代表ESRD发展的关键时期。CRF的迹象和 症状最初是很小的，但是经过2-5年的过程，变得日益严重并且不可恢复。尽管在与ESRD进 展和并发症的抗争中已经取得了一些进展，但是现有发明的临床益处是有限的。

[0031] 几十年来已经知道，不同病因（低血压、感染、外伤、自体免疫疾病等）的肾病可以 导致CRF综合征，其特征在于系统性的高血压、蛋白尿(过量的蛋白从血液过滤到尿中）和日 益下降的GFR，最终导致ESRD。这些观察表明，CRF通过常规机制途径发展，并且不管起始的 原因，抑制这一常规途径的治疗干预可以成功地减缓CRF的发展。

[0032] 为了起始CRF恶性循环，肾脏的初始损伤引起一些肾单位的丢失。为了保持正常的 GFR，存在在剩余的肾单位中导致超滤状态的补偿性肾脏和系统机制的激活。然而，最后，越 来越多数目的“过度工作的”并且受到超滤损坏的肾单位丢失。在某种程度上，失去足够数 目的肾单位，以致不再能够维持正常的GFRXRF的这些病理变化产生恶化的系统性高血压， 因而产生高肾小球压力和增加的超滤。CRF中增加的肾小球超滤和渗透性促使增加量的来 自血液的蛋白穿过肾小球并且进入到肾小管中。这种蛋白对于小管有直接的毒性，并且导 致肾单位的进一步损失，增加CRF的发展速度。由于GFR随着多余的肾单位的损失而下降，所 以这种CRF的恶性循环持续，导致进一步的超滤，并且最终导致需要透析的ESRD。临床上，已 经表明高血压和过量的蛋白过滤是CRF句ESRD发展速率中的两种主要决定因素。

[0033] 尽管先前临床上就已经知道，但是直到20世纪80年代才确定了高血压、蛋白尿、肾 单位丢失和CRF之间的生理学联系。在20世纪90年代，阐明了交感神经系统活性的作用。由 于机械感受器和化学感受器的激活而产生于损伤肾脏的传入信号刺激大脑负责血压控制 的区域。响应中，大脑增加关于系统水平的交感刺激，主要通过血管的血管收缩引起增加的 血压。当升高的交感神经刺激通过传入交感神经纤维到达肾脏时，它产生两种形式的主要 恶化作用。肾脏受到来自肾脏中交感神经递质(诸如去甲肾上腺素)不依赖高血压的释放的 直接肾脏毒性的损害。此外，激活血管紧张素II的肾素的分泌增加，其增加系统性血管收缩 并且加剧高血压。

[0034] 随着时间过去，肾脏的损伤导致从肾脏到大脑的传入交感信号的进一步增加。升 高的血管紧张素II进一步促进内在的神经递质的肾释放。因此，反馈回路关闭，这加快了肾 脏的恶化。

[0035] 考虑到前文，有必要提供通过肾神经调节和/或去神经作用治疗充血性心力衰竭、 肾病、高血压和/或其它心-肾疾病的方法和装置。

[0036] 概述

[0037] 本发明提供使用脉冲电场(PEF)进行肾神经调节(例如，去神经作用）的方法和装 置。本发明的一些方面应用脉冲电场在肾神经、引起肾神经功能或其它肾特征的其它神经 纤维中完成电穿孔和/或电融合。本发明的一些实施方案是诱导肾神经调节作用的血管内 装置。本文所述的装置和方法可以应用实现神经调节包括去神经作用，和/或另外产生电穿 孔和/或电融合作用的任何适当的电信号或场参数。例如，电信号可以结合纳秒脉冲电场 (nsPEF)和/或PEF用于完成电穿孔。一个具体的实施方案包括应用第一过程的PEF电穿孔， 然后第二过程的nsPEF电穿孔，以在PEF处理后保持完好的任何细胞中诱导凋亡，或者反之 亦然。一个备选的实施方案包括以某种方式应用PEF而融合神经细胞，希望这可以减少或者 消除神经传导电刺激的能力。当将所述方法和装置用于肾神经和/或引起肾神经功能的其 它神经纤维时，本发明人相信，尿输出将增加和/或血压将以某种形式得到控制，这将预防 或治疗CHF、高血压、肾系统疾病以及其它肾异常。

[0038] 通过选择适当的PEFs和/或nsPEFs的参数，具体实施方案的一些方面可以实现这 样的结果。脉冲电场参数可以包括，但不限于，场强、脉冲宽度、脉冲形状、脉冲数目和/或脉 冲之间的时间间隔（例如，占空比）。例如，适宜的场强包括高达约l〇,〇〇〇V/cm的强度。例如， 适宜的脉冲宽度包括高达约1秒的宽度。例如，适宜的脉冲波形形状包括AC波形、正弦曲线 波、余弦波、正弦和余弦波的组合、DC波形、DC-偏移AC波形、RF波形、方波、梯形波、指数衰减 波、它们的组合等。例如，适宜的脉冲数目包括至少一个脉冲。例如，适宜的脉冲时间间隔包 括小于大约10秒的间隔。当需要时，可以应用这些参数的任何组合。这些参数为了举例说明 而提供，决不应该认为是限制。其它的和备选的波形参数应该是显而易见的。

[0039] —些实施方案针对经皮的血管内系统，用于提供长期持续的去神经作用以将急性 心肌梗塞（“AMI”）扩展减到最少，并且用于帮助预防与充血性心力衰竭相关的形态变化的 发作。例如，本发明的一个实施方案包括治疗患有梗塞的患者，例如，通过冠状血管成形术 和/或支架（stenting)进行治疗，和在荧光镜指导下实行动脉内部脉冲电场肾去神经作用 流程。备选地，在AMI稳定后不久，可以在独立的时间输送PEF治疗。肾神经调节作用还可以 用作肾手术方法的辅助治疗。在这些实施方案中，预计由肾PEF治疗提供的尿输出的预计增 加和/或血压的控制将减轻心脏负荷，从而抑制梗塞的扩展并且预防CHF。

[0040] 本文所述的血管内脉冲电场系统的一些实施方案可以在梗塞后立即，或者在其后 的任何时间，去除神经或者减少肾神经供应的活性，而不会在患者中留下永久的植入物。预 计这些实施方案将在几个月的时期内增加尿输出和/或控制血压，在这段时期内患者的心 脏可以治愈。如果确定在这一治愈期间后重复的和/或慢性神经调节将是有利的，那么可以 根据需要重复肾PEF治疗。

[0041] 除了有效地治疗AMI，本文所述的系统的一些实施方案还希望治疗CHF、高血压、肾 衰竭、以及受增加的肾交感神经活性影响的其它肾脏或心-肾疾病。例如，所述系统可以随 时用于治疗CHF，其通过血管结构将PEF系统推进到治疗位点，然后将PEF治疗输送到所述治 疗位点而进行。例如，这可以改进流体清除的水平。

[0042] 本文所述的血管内PEF系统的实施方案可以类似地用于本领域公知的血管成形术 或电生理学导管。例如，通过标准塞尔丁格技术可以获得动脉通路，并且任选地可以放置动 脉鞘以提供导管通路。导线(guidewire)可以通过血管系统向前推进，并且进入患者的肾动 脉，然后血管内PEF可以沿着导线向前推进和/或通过所述鞘进入肾动脉。所述鞘任选地可 以在插入PEF导管之前放置，或者与PEF导管一起向前推进，以便所述鞘部分地或完全地覆 盖所述导管。备选地，PEF导管可以无需使用导线直接通过血管系统向前推进，和/或无需鞘 而引入并且向前推进到血管系统中。

[0043] 除了动脉放置，PEF系统可以放置在静脉内。例如，静脉通路可以通过颈静脉途径 获得。例如，PEF系统可以用于肾动脉内、肾静脉内或者肾动脉和肾静脉二者内，以促进更完 全的去除神经作用。

[0044] 在将PEF导管置于关于靶点神经元的理想位置的血管内后，将它稳定在血管内部 (例如，顶着血管壁稳定），并且将能量输送到靶点神经或神经元。在一种变体中，将脉冲的 RE能量输送到祀点，以产生非热量神经阻滞(non-thermal nerve block)，减少神经信号传 导，或者另外调控神经活性。备选地或另外地，冷却的、低温的、热RF、热或非热微波、聚焦的 或非聚焦的超声、热或非热DC以及它们的任何组合可以用来减少或者另外控制神经信号传 导。

[0045] 在本发明的另一个实施方案中，除了或者代替肾神经结构外，其它非肾神经结构 可以靶向动脉或静脉管道内。例如，PEF导管可以通过大动脉或者腔静脉，并且开始与各种 神经结构并列，以治疗其它病症或者增强肾脏-心脏病症的治疗。例如，腰部交感神经链的 神经体(nerve bodies)可以以这种方式进入和调控，阻滞或消融等。

[0046] PEF系统的一些实施方案可以完全阻滞或者去除靶点神经结构的神经，或者PEF系 统可以另外调控肾神经活性。由于与完全的神经阻滞诸如去除神经作用相反，其它神经调 节作用在肾脏和其余机体之间的肾神经活性水平上产生小于完全的变化。因此，改变脉冲 电场参数将对神经活性产生不同的作用。

[0047] 在一个血管内脉冲电场系统的实施方案中，所述装置包括一个或多个电极，将其 设置成与肾血管的靶点区域接触，以输送脉冲电场。例如，所述装置可以包括具有可扩张的 螺旋部件的导管和在所述螺旋部件上的一个或多个电极。所述导管可以以低剖面构型位于 肾血管内。然后，所述可扩张的部件可以扩张，以接触血管壁的内表面。备选地，所述导管可 以具有一个或多个可扩张的螺旋电极。例如，第一和第二可扩张的电极可以以彼此之间理 想的距离位于管内，以提供作用电极和回流电极(return electrode)。可扩张的电极可以 包括形状-记忆物质、膨胀气球、可扩大的网孔、连接系统、以及可以以可控方式扩大的其它 类型的装置。适当扩大的连接系统包括可扩张的篮(expandable baskets)，其具有多个形 状-记忆电线或开槽海波管(hypotubes)、和/或可扩张的环。另外，所述可扩张的电极可以 是沿着导管的气球部分排列的点接触电极。

[0048] 脉冲电场的其它实施方案包括不与血管壁物理接触的电极。RF能，传统热能和相 对非热脉冲RF二者，是可以从距离组织本身的短距离传入要治疗的组织的脉冲电场的实 例。其它类型的脉冲电场也可以用于其中电极与血管壁没有物理接触的情形中。同样地，脉 冲电场可以通过电极触头和血管壁或其它组织之间的物理接触而直接应用于神经，或者脉 冲电场可以无需电极触头与血管壁的物理接触而间接用于神经。因此，术语“神经接触”包 括系统元件与神经和/或紧接所述神经的组织的物理接触，以及没有与神经或组织的物理 接触的单独的电接触。为了间接应用所述脉冲电场，所述装置具有定中心元件(centering element)，其被设置成将电极置于血管中心区域或者电极远离血管壁的其它空间的中心区 域。所述定中心元件可以包括，例如，气球或可扩张的篮。一个或多个电极可以位于定中心 元件的中心轴上--与所述元件纵向排列或者位于所述元件的任一面上。当应用球导管 时，膨胀的气球可以作为增加的阻抗的绝缘体，用于确定或者指导脉冲电场沿着理想的电 流途径的方向。显而易见地，可以应用备选的绝缘体。

[0049] 在所述系统的另一个实施方案中，一种组合装置包括血管内导管，其具有设置成 与血管壁物理接触的第一电极，和设置成位于血管内但在空间上远离血管壁的第二电极。 例如，可扩张的螺旋电极可以与中心布置的电极组合，以提供这样的双极电极对。

[0050] 在另一个实施方案中，可以将一个或多个电极相对于血管壁的辐向位置进行动态 改变，以聚焦由电极输送的脉冲电场。在另一种变化中，电极可以设置成部分或完全通过血 管壁。例如，电极可以位于肾静脉内，然后通过肾静脉壁进入血管周隙空间，以致它们在输 送脉冲电场之前至少部分地环绕肾动脉和/或静脉。

[0051] 本发明的双极性实施方案可以设置成相对于作用电极和接地电极之间的间距进 行动态运动或操作，以实现通过理想距离、体积或其它维度的治疗。例如，可以安排多个电 极，以便双极性电极对可以相对于彼此纵向移动，以调整电极之间分离的距离和/或改变治 疗的位置。一个具体的实施方案包括偶联到导管上的第一电极，和可移动的第二电极，所述 第二电极可以通过导管的内腔移动。在备选实施方案中，第一电极可以附着到导管上，并且 第二电极可以附着到内腔-输送的(endoluminally-delivered)装置上，以致第一和第二电 极可以相对于彼此重新定位，以改变电极之间的分离距离。这样的实施方案可以促进各种 肾血管系统解剖学治疗。

[0052] 本文所述的本发明的任何实施方案任选地可以设置成将试剂在能量应用之前、之 中或之后灌注到治疗区域。可以选择灌注的试剂，以增强或改进能量应用的神经调节效果。 所述试剂还可以保护或者临时转移非靶点细胞，和/或促进显现。

[0053] 本发明的一些实施方案可以包括促进确定治疗位置和/或检测或证实治疗成功性 的检测器或其它元件。例如，所述系统可以设置成还输送刺激波形，并且监测已知应答肾神 经刺激的生理参数。基于所监测的参数的结果，所述系统可以确定肾神经的位置和/或去除 神经作用是否发生。监测这样的生理反应的检测器包括，例如，多普勒元件、热电偶、压力传 感器、和成像手段(例如，荧光镜透视、血管内部超声等）。备选地，例如，可以直接使用电阻 抗体层摄影术（“EIT”）或者其它电阻抗检测法来监测电穿孔作用。其它的监测技术和元件 是显而易见的。这样的检测器可以与PEF系统结合，或者它们可以是独立的元件。

[0054] 另一个具体实施方案包括设置成将电场沿着靶点细胞的较长尺度排列的电极。例 如，神经细胞倾向于是延长结构，长度极大地超过它们的横向尺寸(例如，直径）。通过排列 电场，以致场传播的方向性优先地影响细胞的纵向方面，而不是细胞的横向方面，预计可以 应用更低的场强来杀死或者使得靶点细胞失去能力。这希望保持植入装置的电池寿命，减 少对邻近结构的附属作用，并且另外增强调控靶点细胞神经活性的能力。

[0055] 本发明的其它实施方案针对这样的应用，S卩，其中在神经之上或之下的组织中的 细胞的纵向维度关于神经细胞的纵向方向是横向的（例如，垂直或者另外以某种角度）。这 些实施方案的另一个方面是排列PEF的方向，以致所述电场沿着靶点细胞的较长的维度和 非靶点细胞的较短的维度排列。更具体地，动脉平滑肌细胞是典型的延长细胞，其以通常是 螺旋的方向围绕动脉圆周，以致它们的较长维度是圆周性的而不是沿着动脉纵向进行的。 另一方面，肾丛的神经通常以动脉的纵向方向沿着动脉外部排列的。因此，预计应用一般沿 着动脉的纵向方向排列的PEF优先在靶点神经细胞中引起电穿孔，而没有在相同程度上影 响至少一些非靶点动脉平滑肌细胞。这可以使得在血管内装置的血管外膜或动脉周围区域 中的神经细胞(靶点细胞)优先去除神经，而没有在不理想的程度上影响血管的平滑肌细 胞。

[0056] 附图简述

[0057] 当结合附图考虑下述详细描述时，本发明的一些实施方案将是显而易见的，在附 图中，相似的参考符号始终是指相似的部件，并且附图中：

[0058] 图1是图示人肾脏解剖的示意图。

[0059] 图2是显示肾神经相对于肾动脉的位置的示意性详图。

[0060] 图3A和3B分别是图示选择性影响肾神经的电流流动方向的示意性侧面图和端面 图。

[0061] 图4是按照本发明的一个实施方案具有多个电极的血管内导管的示意性侧面图， 特别是横截面图。

[0062] 图5是按照本发明另一个实施方案具有一对彼此以理想的距离排列的可扩张的螺 旋电极的血管内装置的示意性侧面图，特别是横截面图。

[0063] 图6是按照本发明的另一个实施方案具有在可扩张的气球上的第一电极和在导管 轴上的第二电极的血管内装置的示意性侧面图，特别是横截面图。

[0064] 图7是按照本发明的另一个实施方案具有沿着导管内腔输送的扩张的第一电极和 由所述导管携带的互补性第二电极的血管内装置的示意性侧面图，特别是横截面图。

[0065] 图8是按照本发明的另一个实施方案具有可扩张的篮和在篮上的多个电极的血管 内装置的示意性侧面图，特别是横截面图。

[0066] 图9是图8的装置的示意性详图，其图示按照本发明的另一个实施方案的一个电极 的实施方案。

[0067] 图10是按照本发明的另一个实施方案具有接触血管壁的可扩张的环性电极和任 选的绝缘元件的血管内装置的示意性侧面图，特别是横截面图。

[0068] 图11A-11C是图10的环形电极不同绕组的实施方案的示意性详图。

[0069] 图12具有图IIA-11C所示的绕组的图10环电极的血管内装置的示意性侧面图，特 别是横截面图。

[0070]图13是按照本发明的另一个实施方案具有环形电极和内腔输送的（Iuminally-delivered)电极的血管内装置的示意性侧面图，特别是横截面图。

[0071] 图14是按照本发明的另一个实施方案具有气球导管与接近和远离气球排列的可 扩张的点接触电极的血管内装置的示意性侧面图，特别是横截面图。

[0072] 图15是按照本发明的另一个实施方案具有气球导管与接近和远离气球排列的电 极的血管内装置的示意性侧面图。

[0073] 图16A和16B是图示按照本发明的一个实施方案使用图15的装置的方法阶段的示 意性侧面图，特别是横截面图。

[0074] 图17是按照本发明的另一个实施方案具有气球导管和多个动力学可操纵的电极 的血管内装置的示意性侧面图。

[0075] 图18是按照本发明的另一个实施方案具有沿着气球导管内腔布置的远端电极的 血管内装置的示意性侧面图。

[0076] 图19A和19B是图示使用图18所示的血管内装置调节具有不同的肾血管系统的患 者肾神经活性的方法的侧面图，特别是横截面图。

[0077] 图20是图示按照本发明的另一个实施方案具有多个沿着定中心元件的轴并且与 定中心元件直线排列的电极的血管内装置的侧面图，特别是横截面图。

[0078] 图21是图示按照本发明的另一个实施方案具有设置成动态径向重新定位以促进 脉冲电场的聚焦的电极的血管内装置的侧面图，特别是横截面图。

[0079] 图22是图示按照本发明的另一个实施方案具有灌注/抽吸导管的血管内装置的侧 面图，特别是横截面图。

[0080] 图23A-23C分别是侧面图特别是横截面图，和沿着横断线图23A的A--A的横截面 图，图示使用按照本发明的一个实施方案设置成电极至少部分通过血管壁的血管内装置的 方法。

[0081] 图24A和24B是图示按照本发明的另一个实施方案具有检测或监测治疗效果的检 测器的血管内装置的侧面图，特别是横截面图。

[0082] 详述

[0083] A.概述

[0084] 本发明涉及肾神经调节和/或其它神经调节的方法和装置。更具体地，本发明涉及 使用脉冲电场完成电穿孔或电融合而进行肾神经调节的方法和装置。当用于本文时，电穿 孔和电渗透作用是操作细胞膜或细胞内装置的方法。例如，短的高能脉冲导致细胞膜上的 开孔。细胞膜上有孔的程度(例如，孔的大小和数目）和孔的持续时间（例如，暂时的或永久 的)是场强、脉冲宽度、工作周期、场方向、细胞类型和其它参数的函数。一般地，当更低强度 的场或较短的脉冲宽度终止时，孔通常自动关闭（这里定义为“可逆电穿孔”）。每一细胞类 型具有临界阈值，高于所述阈值，孔不会关闭，以致孔的形成不再是可逆的；这一结果定义 为“不可逆电穿孔”、“不可逆击穿”或“不可逆损伤”。在这一点上，发生由高有孔性引起的细 胞膜破裂和/或不可逆的化学不平衡。这样的高有孔性可能是单个大孔和/或多个更小的孔 的结果。也适于用于肾神经调节的某些类型的电穿孔能量参数是具有亚微秒范围持续时间 的高电压脉冲(纳秒脉冲电场，或nsPEF)，其可以使得细胞膜完好无损，但是以引起细胞死 亡或破裂的方式改变细胞内装置或细胞的功能。已经表明nsPEF的某些应用通过诱导凋亡 (apoptosis)或程序性细胞死亡(programmed cell death)而不是急性细胞死亡而引起细 胞死亡。并且，术语“包括”贯穿全文用来意指包括至少引用的特征，以便任何更大量的相同 特征和/或其它类型特征不被排除在外。

[0085] 本发明的一些实施方案提供诱导肾神经调节的血管内装置，所述肾神经调节诸如 靶点神经中随着时间消散的临时性变化，对神经功能的持续控制，和/或去除神经作用。本 文所述的装置和方法可以使用获得理想的神经调节(例如，电穿孔作用）的任何适宜的电信 号或场参数，例如，任何电场。为了更好地理解血管内装置的结构和使用这些装置进行神经 调节的方法，理解人体肾脏解剖结构是有用的。

[0086] B ·神经调节方法的选择实施方案

[0087] 现在参考图1，人肾脏解剖结构包括通过肾动脉RA供应有氧血的肾脏K，肾动脉RA 通过腹部大动脉AA与头部相连。去氧血液通过肾静脉RV和下腔静脉IVC从肾脏流到心脏。图 2更详细地图示肾脏解剖结构的部分。更具体地，肾脏解剖结构还包括沿着通常在动脉外膜 内的肾动脉RA的纵向维度而纵向延伸的肾神经RN。肾动脉RA具有平滑肌细胞SMC，其围绕动 脉的角轴Θ螺旋而环绕动脉圆周，S卩，环绕动脉的圆周。因此，肾动脉的平滑肌细胞具有横断 肾动脉的纵向维度（即不平行)延伸的纵向或较长维度。肾神经和平滑肌细胞的纵向维度的 不重合(misalignment)定义为“细胞不重合”。

[0088] 参考图3,肾神经和平滑肌细胞的细胞不重合可以用来选择性地影响肾神经细胞， 而对平滑肌细胞具有减小的作用。更具体地，由于更大的细胞需要更少的能量超过电穿孔 的不可逆阈值，所以，本发明的一些电极的实施方案设置成将由所述电极产生的至少部分 电场沿着或者靠近要影响的细胞的较长维度排列。在具体的实施方案中，血管内装置具有 这样的电极，即，所述电极被设置成产生沿着或者靠近肾动脉RA的纵向维度排列的电场，以 影响肾神经RN。通过排列电场，以便所述场优先影响细胞的纵向方面，而不是细胞的直径或 辐射状方面，可以使用更低的场强来使细胞坏死。如上文所提及的那样，预计这可以减少能 量消耗，并且减轻对电场中非靶点细胞的作用。

[0089] 类似地，相对于神经细胞的较长维度而言，在靶点神经之上或之下的组织的纵向 或较长的维度是垂直的或另外偏离轴线的(off-axis)(例如，横截的）。因此，除了沿着靶点 细胞的纵向或较长维度排列PEF之外，PEF可以沿着非靶点细胞的横向或较短维度传播（SP， 以致PEF至少部分不沿着非靶点平滑肌细胞SMC排列地传播）。因此，如在图3中所示，使用具 有通常沿着肾动脉RA的纵向维度L排列的传播线Li的PEF，预计优先在靶点肾神经RN细胞中 引起电穿孔、电融合、去除神经作用或其它神经调节，而不会不适当地影响非靶点动脉平滑 肌细胞SMC。脉冲电场可以以沿着肾动脉纵轴的单个平面传播，或者可以以沿着从0°-360° 的任何角面(angular segment) Θ的纵向方向传播。

[0090] 图3所示方法的实施方案可以具有关于本发明血管内方法和装置的具体应用。例 如，置于肾动脉内的PEF导管可以传播具有纵向部分的电场，所述电场在肾神经RN和血管壁 的平滑肌细胞SMC区域沿着动脉的纵向维度排列运行，以致动脉壁保持至少基本上是完好 的，而外部的神经细胞被破坏。

[0091] C.神经调节的系统和其它方法的实施方案

[0092] 图4显示按照本发明的血管内脉冲电场装置200的一个实施方案，所述装置包括一 个或多个电极，所述电极设置成与肾血管系统内的靶点区域物理接触，并且将脉冲电场输 送穿过血管系统的壁。装置200显示位于患者肾动脉RA内，但是它可以位于其它血管内位置 (例如，肾静脉）。装置200的这一实施方案包括血管内导管210，其具有近端部件21 la、远端 部件211b、和在远端部件211b的多个远端电极212。近端部件211a通常具有将导管210偶联 到脉冲发生器上的接线盒，并且这一实施方案中的远端部件211b具有螺旋构型。装置200电 偶联到位于患者近端和外部的脉冲电场发生器100上；电极212通过导管210电偶联到发生 器上。发生器100可以用于下文所述的本发明的任何实施方案中，用于输送具有理想场参数 的PEF。应该理解，即使所述发生器没有在每个变例中明确地显示或者描述，下文所述的实 施方案的电极也可以与发生器连接。

[0093] 导管210的螺旋远端部件211b被设置成与血管壁并列(appose)，并且将电极212引 入到血管外神经结构的最近处。螺旋的斜度可以变化，以提供较长的治疗区域，或者将相邻 治疗区域的圆周重叠减到最小，以减少形成血管狭窄的危险。这种斜度变化可以通过将多 个不同斜度的导管组合形成导管210而获得，或者通过应用内部牵引线、插入到导管内的调 节轴、置于导管上的定型鞘调整导管210的斜度而获得，或者通过任何其它适当的方式在原 位或者在引入到机体之前而改变所述斜度。

[0094] 沿着斜度长度的电极212可以是一个个单个电极，同一但是分节的电极，或者同一 而连续的电极。例如，同一且连续电极可以包括在导管210的螺旋部分内部形成或者置于其 上的传导线圈。例如，同一但是分节的电极可以通过提供装配到导管的螺旋部分上或内的 有槽管而形成，或者通过电连接一系列的单个电极而形成。

[0095] —个个单个电极或电极组212可以设置成提供双极信号，或者所有的电极或电极 子集可以与独立的外部患者接地组合在一起用于单极应用（例如，接地盒可以置于患者腿 上）。电极212可以动态地分配以促进任何电极之间和/或任何电极和外部接地之间的单极 和/或双极能量输送。

[0096] 导管210可以以在鞘150内部低剖面的输送构型输送到肾动脉RA。一旦位于动脉内 部，导管可以自动膨胀或者主动膨胀，例如，通过牵引线或者气球而膨胀，与动脉内壁接触。 然后，脉冲电场可以通过PEF发生器100产生，通过导管210传导到电极212,并且通过电极 212输送穿过动脉壁。在许多应用中，电极的排列使得脉冲电场沿着动脉的纵向维度排列， 以沿着肾神经调控神经活性(例如，去除神经作用）。例如，这可以通过不可逆的电穿孔、电 融合和/或在神经细胞中诱导凋亡而实现。

[0097] 图5图示按照本发明的另一个实施方案的肾调节装置220。装置220包括一对导管 222a和222b，其分别具有可扩张的远端部件223a和223b，223a和223b分别具有螺旋电极 224a和224b。在患者肾血管系统内部，螺旋电极224a和224b在空间上彼此距离理想的距离。 电极224a-b可以以两极方式作用，以致一个电极是作用电极，另一个电极是回流电极。电极 之间的距离可以按照需要改变，以改变场强和/或受电极调控的神经片段的长度。所述可扩 张的螺旋电极可以包括形状-记忆特性，所述形状-记忆特性促进自动膨胀，例如在穿过鞘 150后自动膨胀，或者所述电极可以主动膨胀以与血管壁接触，例如，通过膨胀的气球或通 过牵引线等而主动膨胀。导管222a-b优选地在除电极224a-b的远端螺旋以外的区域是电绝 缘的。

[0098] 图6图示装置230,其包括具有可扩张的气球234的气球导管232,围绕气球234排列 的螺旋电极236,和在导管232轴上的轴电极238。轴电极238可以如所示那样位于可扩张的 气球234的近端，或者轴电极238可以位于可扩张的气球234的远端。

[0099] 当将装置230输送到靶点血管时，例如位于肾动脉RA内部时，可扩张的气球234和 螺旋电极236以低剖面的输送构型布置。如图6所示，一旦所述装置已经位于需要的位置，可 扩张的气球234可以膨胀，推动螺旋电极236与血管壁物理接触。在这一实施方案中，轴电极 238不与血管壁物理接触。

[0100] 在常规热RF能量输送和相对非热脉冲RF能量输送领域内，公知能量可以从距离组 织本身的短距离传导到要治疗的组织。因此，可以理解“神经接触”包括系统元件与神经的 物理接触，以及没有物理接触而只有电接触，或者两者的组合。任选地可以提供定中心元 件，以将电极置于血管的中心区域。例如，所述定中心元件可以包括可扩张的气球诸如装置 230的气球234、或下文所述的可扩张的篮。一个或多个电极可以位于定中心元件的中心轴 上一一与所述元件纵向排列或者位于所述元件的一侧或两侧一一如同装置230的轴电极 238。当应用气球导管诸如导管232时，膨胀的气球可以作用为增加阻抗的绝缘体，以引导脉 冲电场沿着理想的电流路径。显而易见可以应用备选的绝缘体。

[0101] 如图6所示，当螺旋电极236与肾动脉RA的壁物理接触时，发生器100可以产生PEF， 以致电流以两极方式在螺旋电极236和轴电极238之间通过。PEF沿着线Li在电极之间传导， 线Li通常沿着动脉纵向维度延伸。气球234在患者血管内局部绝缘和/或增加阻抗，以致PEF 通过螺旋电极和轴电极之间的血管壁而传导。这聚焦了能量，增强去除神经作用和/或患者 肾神经的其它神经调节作用，例如，通过不可逆的电穿孔进行。

[0102] 图7图示按照本发明的另一个实施方案与图4-6所示的那些装置相似的装置240。 装置240包括具有可扩张的气球244的气球导管242和位于可扩张的气球244近端的轴电极 246。装置240还包括可扩张的螺旋电极248,其设置成用于通过导管242的导线内腔243进行 输送。图7所示的螺旋电极248是自动扩张的。

[0103] 如图7所示，在将导管242置于靶点血管（例如，肾动脉RA)后，气球244膨胀直到它 接触到血管壁，以将轴电极246保持在血管内的理想位置，并且绝缘或者增加血管内部的阻 抗。气球244通常设置成还将轴电极246位于血管内的中心，或者另外地使轴电极距离血管 壁理想的距离。在气球244膨胀后，螺旋电极248沿着内腔243推进，直到螺旋电极248超过导 管轴;然后电极248扩张或者另外移动成螺旋构型以便与血管壁物理接触。然后，两极脉冲 电场可以沿着线Li在螺旋电极148和轴电极246之间输送。例如，螺旋电极248可以包括作用 电极，并且轴电极246可以包括回流电极，反之亦然。

[0104] 现在参考图8,描述了包括可扩张的篮的装置，所述篮具有多个电极，其可以扩张 与血管壁接触。装置250包括导管252,其具有可扩张的篮254,篮254由多个圆周支柱或部件 形成。多个电极256沿着篮254的部件形成。篮的每一部件示例性地包括两极电极对，所述两 极电极对设置成与肾动脉RA壁或者另一理想的血管壁接触。

[0105] 例如，篮254可以由多个形状-记忆线或带构成，诸如镍钛诺(Nitinol)、弹簧钢或 埃尔吉洛伊非磁性合金线或带，它们形成篮部件253。当篮部件包括带时，带可以移动，以便 增加接触血管壁的表面区域。篮部件253分别在近端和远端连接255a和255b与导管252偶 联。在这样的构型中，篮可以折叠（collapsed)以在鞘150内输送，并且一旦从鞘内移出，就 可以自动膨胀与动脉壁接触。近端和/或远端连接255任选地可以设置成沿着导管252的轴 平移指定的或不指定的距离，以促进篮的膨胀和折叠。

[0106] 篮254备选地可以由开槽的和/或激光切割的海波管形成。在这样的构型中，例如， 导管252可以包括相对于彼此可以移动的内轴和外轴。篮254的远端连接255b可以偶联到内 轴上，并且篮的近端连接255a可以偶联到外轴上。篮254可以通过使得导管252的内轴和外 轴接近，从而使得篮的近端和远端连接255接近并且扩张所述篮，而从折叠的输送构型扩张 成为图8的展开构型。同样地，所述篮可以通过分离导管的内轴和外轴而折叠。

[0107] 如图9所示，一个个单个电极可以沿着篮支柱或部件253排列。在一个实施方案中， 所述支柱由用绝缘材料包被的传导材料形成，并且电极256可以通过去除绝缘涂层区域而 形成。绝缘任选地可以只沿着部件的径向外表面去除，以便电极256在它们的径向内表面保 持绝缘;预计这将把外部电流导入血管壁内。

[0108] 作为图9的制造技术的附加方案或备选方案，电极可以固定在篮254的支柱或部件 的内部表面、外部表面或者包埋在其中。沿着每一支柱或部件放置的电极可以包括一个个 单个电极、同一但是分节的电极、或者同一而连续的电极。一个个单个电极或电极组可以构 造成提供双极信号;或者，所有电极或是电极子集可以与外部患者接地组合在一起作用，用 于单极用途。

[0109] 如图8的实施方案所示使得电极256与血管壁接触的一个优点是它可能减少获得 肾去除神经作用或其它的神经调节而对绝缘元件诸如可扩张的气球的需求。然而，应该理 解，例如，这样的绝缘元件可以在篮内提供并且扩张。此外，使得电极接触壁可以提供提高 的场几何学，即，可以提供更加沿着血管纵轴排列的电场。这样的接触电极还可以在肾神经 调节之前、之中或之后促进肾神经刺激，以便在治疗之前更好地定位导管252,或者监测治 疗的功效。

[0110] 在装置250的一种变体中，电极256可以沿着导管252的中心轴排列，并且篮254可 以简单地将电极定于血管内中心，以促使能量穿过血管壁更精确地输送。这种构型可以非 常适合精确靶向血管或血管外组织，诸如围绕肾动脉的肾神经。准确衡量篮或其它定中心 元件相对于动脉的尺寸提供位于中心的电极和动脉壁之间的距离，当需要时，其可以用来 引导和/或聚焦电场。这种构型可以用于高强度聚焦超声或微波应用，而且当需要时可以适 于与任何其它的能量形式一起应用。

[0111] 现在参考图10,预计形成与肾动脉壁的圆周接触的电极可以提供更完全的肾去除 神经作用或肾神经调节作用。在图10中，描述了本发明包括环形电极的一种变体。装置260 包括导管262,其具有可扩张的环形电极264a和264b，所述电极设置成与血管壁接触。电极 可以通过支柱266附着到导管262的轴上，并且导管262可以设置成以低剖面构型通过鞘150 输送到肾动脉RA。支柱266可以自动扩张或者可以主动地或机械地扩张。导管262包括导线 内腔263用于推进导线。导管262还包括任选的膨胀的气球268,其可以作用为增加阻抗的绝 缘元件，用于优先引导在电极264之间传导的电流穿过动脉壁。

[0112] 图11A-11C图示环形电极264的各种绕组实施方案。如所示的那样，例如，环形电极 可以绕组成线圈（图11A)，Z字形（图11B)或曲折构型（图11C)。按照需要，绕组的周期可以是 特异的。此外，绕组类型、周期等可以沿着电极圆周而变化。

[0113] 参考图12,描述了装置260的一种变体，其包括环形电极264’，环形电极264’具有 在图IlC中所示的一种曲折绕组实施方案中的正弦绕组。支柱266示例性地附着到正弦曲线 的顶点。电极264’的绕组可以提供比电极264更大的沿着血管壁的接触区域，同时仍然促使 装置260的包复物在鞘150内输送和取回。

[0114] 图13图示装置260的另一种变体，其包括近端环形电极264a，并且还包括通过导管 262的导线内腔263输送的远端电极270。远端电极270是非扩张性的，并且通过导管262位于 血管中心。远端电极270可以是与脉冲电场发生器相连并且用作电极的标准导线。然而，应 该理解，电极270备选地可以设置成扩张与血管壁接触，例如，可以包括环形或螺旋形电极。 [0115] 通过导管262的内腔输送远端电极可以减小装置260的输送剖面（delivery profile)和/或可以提高装置的挠性。此外，通过导线内腔输送远端电极可以作为安全特 征，其确保医药从业者在输送PEF之前移除置于内腔263的任何导线。它还允许定制治疗长 度，以及在旁侧分支的治疗，如下文所述。

[0116] 环形电极264和264’任选地可以是沿着它们的径向内表面而电绝缘，而它们接触 血管壁的径向外表面是暴露的。这可以减少血栓形成的危险，并且还可以提高或增强沿着 血管纵轴的电场的方向性。这还可以促使减小中断神经纤维所需的场电压。至少部分绝缘 所述环形电极所用的材料可以包括，例如，PTFE、ePTFE、FEP、chronoprene、娃氧烧、氨基甲 酸乙酯、Pebax等。参考图14,描述了装置260的另一种变体，其中环形电极被位于支架266末 端的点电极272取代。点电极可以与支柱266—起折叠用于通过鞘150输送，并且可以与支柱 一起自动扩张与血管壁接触。在图14中，导管262示例性地包括在气球268的每一侧面的4个 点电极272。然而，应该理解，可以围绕导管262的圆周提供任何需要数目的支柱和点电极。

[0117] 在图14中，装置260示例性地包括在气球268每一侧面上的4个支柱266和4个点电 极272。通过应用所有位于远端的电极272b作为作用电极，和所有近端电极272a作为回流电 极，或者反之亦然，电场传播所沿着的线Li可以沿着血管纵轴排列。线Li与血管的旋转轴交 迭的程度可以通过规定围绕导管圆周的点电极272的角度定位和密度，以及通过规定PEF的 参数而确定。

[0118] 现在参考图15,描述了血管内PEF导管的另一种变体。装置280包括导管282,其具 有任选的膨胀的气球或定中心元件284,沿着导管轴位于气球每侧的轴电极286a和286b，以 及任选的沿着导管轴放置的辐射不透过性的标记288,它们与气球成直线图示。气球284作 为电极286的定中心元件，并且作为引导电场的电绝缘体，如先前所述那样。

[0119] 由于准确衡量气球284相对于靶点动脉之间的尺寸设定了位于中心的电极286和 动脉壁之间的已知距离，这可以用于当规定了PEF的参数时，所以，装置280可以很好地适用 于获得需要的动脉或动脉外组织的精确靶向。备选地，电极286可以附着到气球284上，而不 是附着到导管282的中心轴上，以致它们可以接触动脉壁。在这样的变体中，电极可以固定 在气球壁的内表面、夕卜表面或包埋在其中。

[0120] 沿着导管282的长度排列的电极286可以是一个个单个电极、同一但是分节的电 极、或同一而连续的电极。此外，电极286可以设置成提供两极信号，或者电极286可以一起 或单独地与分离的患者接地组合应用，用作单极用途。

[0121] 现在参考图16,描述了使用装置280实现肾去除神经作用的方法。如图16A所示，导 管282可以放置在肾动脉RA内需要的位置，气球和定中心元件可以膨胀以使得电极286位于 中心，并且任选地提供电绝缘性，并且，例如，PEF可以以两极性方式在近端电极和远端电极 286之间输送。预计PEF沿着治疗区域T1将实现肾去除神经作用和/或神经调节作用。如果需 要在肾动脉的其它部分调控神经活性，气球284可以至少部分地放气缩小，并且导管可以放 置在第二需要的治疗区域T2,如在图16B中所示。医学执业者任选地可以应用辐射透不过的 标记288的荧光成像以将导管282导向治疗的理想位置。例如，医学执业者可以使用所述标 记以确定治疗区域TdPT22间的重叠区域0,如图示。

[0122] 参考图17,描述了装置280的一种变体，其包括多个位于气球284的近端的动态可 控的电极286。在一种变体中，任何一个近端电极286a可以以两极方式与远端电极286b通 电，以提供作用电极和回流电极之间纵向距离的动态控制。这改变了治疗区域的大小和形 状。在另一种变体中，近端电极286a的任何子集可以一起通电作为在近端电极和远端电极 286b之间建立的两极电场的作用电极或回流电极。

[0123] 尽管图17所示的装置280有3个近端电极286a，但是应该理解，装置280可以具有任 何备选数目的近端电极。此外，除了多个近端电极以外，或者作为备选方案，装置280可以具 有多个远端电极286b。另外，一对电极中的一个可以偶联到导管282上，并且另一个电极可 以通过导管的内腔输送，例如通过导线内腔输送。导管和内腔-输送的电极可以重新相对于 彼此定位，以改变电极之间的分离距离。这样的变体还可以辅助各种肾血管系统解剖结构 的治疗。

[0124] 在到目前所述的装置280的变体中，远端电极偶联到气球284远端的导管282的轴 上。远端电极可以应用导管282内的内腔，例如，用于发送作为接地的导线。另外，气球284远 端的导管282部分足够长，足以容纳远端电极。

[0125] 导管通常在金属的和/或传导的导线上输送。在许多包括导管的介入性治疗中，在 治疗过程中并不将导线去除。由于装置280设置成输送脉冲电场，如果不将导线去除，那么 对于在能量输送过程中接触导线的任何人可能存在电击的危险。这种危险可以通过应用聚 合物包被的导线而减小。

[0126] 参考图18，描述装置280的另一种变体，其中图16和17的远端电极286b己经被远端 电极270取代，远端电极270设置成沿着导管内腔移动，如先前在图13中所述那样。显而易见 地，近端电极286a备选地可以由内腔输送的电极取代，以便电极286b和270形成两极电极 对。电极270不利用导管282内的其它内腔，这可能减小剖面(profile)。另外，气球远端导管 的长度不必占用远端电极的长度，这可以增加挠性。此外，导线必须在治疗之前调换电极 270,这减少无意被电击的危险。在一种变体中，电极270任选地可以用作导线，在电极270之 上导管282在输送PEF之前被推进到位，因而避免了调换导线和电极的需要。备选地，标准金 属导线可以简单地通过将所述标准导线与脉冲电场发生器连接而用作电极270。远端电极 270可以延长到超出导管282远端末端的任何理想的距离。这可以提供治疗区域长度的动态 变化。此外，这可能有助于在减小的直径的远端血管系统内的治疗。

[0127] 参考图19,可以理想地在从主血管延伸出来的一个或多个血管分支内进行治疗， 例如，在邻近肾门的肾动脉的分支内进行治疗。此外，可以理想地在肾血管系统的异常的或 少见的分支内进行治疗，这在少数患者中观察到。如图19A所示，远端电极270可以置于肾动 脉RA的这样的分支内，而导管282位于所述动脉的主分支内，如图19B所示，可以提供多个远 端电极270,并且置于肾动脉的许多常见的或罕见的分支内，而导管保持在主动脉分支内。

[0128] 参考图20，描述了血管内PEF的另一种变体。装置290包括包括导管292，导管292具 有多个与定中心元件296直线放置的轴电极294。定中心元件296示例性地包括可扩张的篮， 诸如先前在图8中所述的可扩张的篮254。然而，应该理解定中心元件备选地可以包括气球 或任何其它定中心元件。电极294可以以两极或单极形式应用。

[0129] 现在参考图21，描述了本发明的另一种变体，其包括设置成将一个或多个电极相 对于血管壁动态重新径向定位的电极，因而促进由所述电极输送的脉冲电场的聚焦。装置 300包括导管302,导管302具有与嵌套的可扩张元件直线放置的电极304。所述嵌套的可扩 张元件包括内部可扩张元件306和外部可扩张定中心元件308。电极304沿着内部可扩张元 件排列，而外部可扩张的定中心元件设置成使导管302位于血管中心并且稳定之。内部元件 306可以膨胀以改变度数，如由医学执业者所需要的那样，以动态改变电极304的径向位置。 这种动态重新径向定位可以用来聚焦由电极304输送的能量，以便它被输送到靶点组织。

[0130] 嵌套元件306和308可以包括气球一在一气球中的排列，篮一在一篮中的排列，气 球和篮的某种组合，或者其它可扩张的嵌套结构。在图21中，内部可扩张元件306示例性地 包括可扩张的篮，而外部可扩张的定中心元件308示例性地包括可扩张的气球。电极302沿 着内部气球306的表面排列。

[0131] 本文所述的本发明的任何变体任选地可以设置成在能量应用之前、之中或之后将 试剂灌输到治疗区域，例如，以增强或者改进能量的神经破坏或神经调节作用，以保护或者 临时转移非靶点细胞，和/或促进显现。灌输试剂的其它应用是显而易见的。如果需要，细胞 对灌输细胞的吸收可以通过在灌输试剂的存在下起始细胞中的可逆电穿孔作用而增强。当 应用气球定中心元件时，灌注可能是特别理想的。灌输剂（infusate)可以包括，例如，盐水 或者肝素化的盐水、保护剂诸如P〇l〇xamer-188、或抗增殖剂。本发明的变体另外或者备选 地可以设置成抽吸式的。例如，灌输端口或出口可以在邻近定中心装置的导管轴上，定中心 元件可以是多孔的(例如，“滴注的”气球），或者篮支柱可以由空心海波管制成，并且是开缝 或者穿孔的以允许灌注或抽吸。

[0132] 参考图22,描述了本发明包括灌输/抽吸PEF导管的变体。装置310包括导管312,导 管312分别具有近端和远端膨胀的气球314a和314b。近端轴电极316a位于沿着导管312的轴 的气球之间，而远端电极316b位于沿着导管轴的气球的远端。一个和多个灌输或抽吸孔318 邻近近端电极316a在气球之间沿着导管312的轴排列。

[0133] 装置310可以以各种方式应用。在第一种应用方法中，导管312位于靶点血管内部， 诸如位于肾动脉RA内，在理想的位置。一个或两个气球充满气，并且保护剂或其它灌输剂通 过在接近电极316a的气球之间的孔318灌输。适于起始可逆电穿孔的PEF由电极316输送，以 促进血管壁内非靶点细胞对灌输剂的吸收。保护剂的输送可以由以下方式增强:先膨胀远 端气球314b，然后灌输保护剂，其取代血液，然后膨胀近端气球314a。

[0134] 剩余的灌输剂任选地可以抽吸出来，以便当起始神经细胞的不可逆电穿孔时，它 在后续PEF应用过程中是不可用的。抽吸可以通过在抽吸过程中将一个气球至少部分地放 气而实现。备选地，抽吸可以用膨胀的气球这样实现，例如，通过灌输盐水与抽吸组合，以冲 洗膨胀的气球之间的血管部分。这样的血液冲洗可以减少在PEF应用过程中沿着近端电极 316a形成凝块的危险。此外，在能量应用过程中的冲洗可以冷却电极和/或动脉壁的细胞。 这样的细胞冷却可以保护细胞免受不可逆电穿孔损伤，可能减少对保护剂灌输的需求。

[0135] 在灌输和任选地抽吸后，适于在靶点神经细胞中起始不可逆电穿孔作用的PEF可 以沿着电极316输送，以去除神经或者调控神经活性。在备选方法中，保护剂的灌输可以在 起始电穿孔作用过程中或之后进行，以保护非靶点细胞。例如，保护剂可以堵塞或者充满非 靶点细胞中通过不可逆电穿孔作用形成的孔。

[0136] 在另一种备选方法中，冷却的（例如，低于体温)肝素化的盐水溶液可以同时在膨 胀的气球之间灌输和抽吸，以冲洗气球之间的区域，并且减少血管壁细胞对电穿孔作用的 敏感性。预计这在应用适于起始不可逆电穿孔作用的PEF过程中进一步保护细胞。这样的冲 洗任选地可以在脉冲电场的整个应用过程中持续进行。热电偶或其它温度传感器任选地可 以位于气球之间，以便可以调节冷却的灌输剂灌输的速率，以保持需要的温度。冷却的灌输 剂优选地不冷却靶点组织，例如，肾神经。保护剂，诸如Poloxamer-188，任选地可以在治疗 后作为附加的安全措施而灌注。

[0137] 灌输备选地可以通过滴注的气球导管而实现。此外，可以应用具有至少一个电极 的冷气球导管(cryoballoon catheter)。冷气球可以在血管部分内部膨胀，以局部减少血 管部分的温度，例如，以在输送电场过程中，保护所述部分和/或诱导血管壁的热程序性细 胞死亡。例如，电场可以包括PEF或热、非脉冲电场，诸如热RF电场。

[0138] 现在参考图23,描述了设置成通过至少部分穿过血管壁的电极的PEF导管的变体。 例如，所述电极可以位于肾静脉内，然后通过肾静脉壁，以便它们位于Gerota’ s或肾筋膜， 并且在肾动脉附近或者至少部分围绕肾动脉。在这种方式中，电极可以在输送脉冲电场之 前被置于靶点肾神经纤维的邻近。

[0139] 如图23A所示，装置320包括导管322，导管322具有针端口 324和定中心元件326，定 中心元件326示例性是一种膨胀的气球。导管322还任选地可以包括辐射透不过的标记328。 针端口 324设置成从中穿过针330，而针330设置成穿过电极340。

[0140] 肾静脉RV与肾动脉RA平行。一种成像形式，诸如血管内超声，可以用来确定肾动脉 相对于肾静脉的位置。例如，血管内超声元件任选地可以结合在导管322内。导管322可以应 用公知的经皮技术而置于肾静脉RV内部，并且定中心元件326可以膨胀以将导管稳定在静 脉内。然后针330可以以某种方式通过导管322并且从针端口 324穿出，从而针穿透肾静脉 壁，并且进入Gerota’ s或肾筋膜F。辐射不透过性标记328可以用荧光镜显现，以在部署针 330之前正确地引导针端口 324的方向。

[0141] 电极340通过针330部署，至少部分环绕肾动脉RA，如在图23A和23B中所示。电极的 持续推进可以进一步环绕动脉，如在图23C中所示。随着电极部署，刺激和/或PEF电穿孔波 形式可以用来去除神经或调控肾神经。针330任选地可以在治疗之前部分或完全地缩回，以 便电极340环绕更多的肾动脉部分。另外，为了提供单极PEF，可以提供和/或开动单一电极 340 〇

[0142] 灌输剂任选地可以从针330灌输到筋膜F，以通过产生电极的放置空间而促进电极 340的放置。灌输剂可以包括，例如，流体、加热的或冷却的流体、空气、CO2、盐水、造影剂、凝 胶、传导性流体、或任何其它的空间占据性物质一一不管是气体、固体或液体。还可以注射 肝素化的盐水。盐水或高渗盐水可以增强电极340之间的传导性。另外或者备选地，药物和/ 或药物输送元件可以通过针灌输或者置于筋膜内。

[0143] 治疗后，电极340可以在针330内部缩回，并且针330可以在导管内通过针端口 324 而缩回。针330任选地足够小，足以发生最小的出血，并且相当迅速地获得止血。为了阻滞血 流并且促进凝固过程，气球定中心元件326任选地可以在收回针330之后保持膨胀一段时 间。备选地，气球导管可以在移除装置320后推进到肾静脉并且膨胀。

[0144] 参考图24,描述了本发明包括检测或监测治疗效果的检测器或其它元件的变体。 除了输送去除神经的或调控的PEFs，本发明的变体可以设置成输送刺激电场。这些刺激场 可以用来准确定位治疗装置，和/或监测调控神经活性中的治疗效果。这可以通过监测已知 受肾神经刺激影响的生理参数的反应而实现。这样的参数包括，例如，肾素水平、钠水平、肾 血流和血压。刺激还可以用来刺激去除神经作用，以监测治疗效果：当将肾神经去除神经 后，针对刺激的已知生理反应应该不再应答这样的刺激而发生。

[0145] 传出神经刺激波形可以，例如，包括大约1-1 OHz的频率，而传入神经刺激波形可 以，例如，包括高达大约50Hz的频率。波形振幅可以，例如，在大约50V范围，而脉冲持续时间 可以，例如，在高达大约20毫秒的范围。当血管内输送神经刺激波形时，如在本发明的一些 实施方案中那样，可以调节场参数诸如频率、振幅和脉冲持续时间，以促进波形通过血管壁 输送到靶点神经。此外，尽管已经描述了刺激波形的本例性参数，但是应该理解，当需要时 可以应用任何备选的参数。

[0146] 在先前所述的本发明的变体中用来输送PEFs的电极还可以用来将刺激波形输送 到肾血管系统。备选地，所述变体可以包括设置用于刺激的独立的电极。作为另一种备选方 案，可以提供分离的刺激装置。

[0147] 应用刺激确定肾神经的一种方法是刺激所述神经，以便如果肾神经没有被去除神 经或调控，那么肾血流受到影响一一或者将受到影响。刺激作用减少肾血流，并且这一反应 可以由去除神经作用而被减弱或消除。因此，在神经调控之前的刺激预计将减少血流，而当 使用如神经调控之前相似的刺激参数和位置时，神经调控之后的刺激预计将不会将血液流 动减少到相同的程度。这一现象可以用来定量肾神经调节的程度。本发明的变体可以包括 监测肾血液流动的元件，或者监测已知受肾刺激影响的的任何其它肾生理参数的元件。

[0148] 在图24A中，描述了图16的装置280的变体，其包括监测肾血液流动的元件。具有多 普勒超声传感器352的导线350沿着导管282的内腔推进，用于监测肾动脉RA内部的血液流 动。多普勒超声传感器352设置成检测流经动脉的速率(velocity)。然后，流量可以按照下 式计算：

[0149] Q = VA (1)

[0Ί50] 其中Q等于流量(flow rate)，V等于流动速率(flow velocity)，以及A等于横截面 面积。肾血流的基线可以通过在输送刺激波形之前来自传感器352的检测而确定，然后刺激 可以在电极286之间输送，优选地使得气球284缩小。肾血流从基线的改变，或者其的缺少， 可以用传感器352监测，以确定神经调节和/或肾神经去除神经作用的最佳位置。

[0151] 图24B示例图24A的装置的变体，其中多普勒超声传感器352偶联到导管282的轴 上。传感器352示例性地位于气球284的近端，但是应该理解，传感器备选地可以位于气球的 远端。

[0152] 除了通过多普勒超声作为血管内监测肾血液流动以外或作为其备选方案，这样的 监测任选地可以从患者外部进行，因而肾血液流动可以从皮肤上可见(例如，使用超声传感 器）。在另一变体中，可以使用一种或多种血管内压力换流器，以感应压力的局部变化，这可 能是肾血流的指征。作为另一种备选方案，例如，可以通过检测在已知分离距离的点之间传 导的血管内温度输入的时间间隔的热稀释(thermodilution)而确定血液速率。

[0153] 例如，热电偶可以结合在每一电极286内，或者在每一电极286的附近提供，并且冷 却的（即，低于体温）的流体或盐水可以在邻近热电偶的地方灌输。在热电偶之间记录的温 度下降的时间间隔可以用来定量流动特征。目的流动特征的基线估计值可以在刺激肾神经 之前确定，并且可以与在刺激后确定的特征的第二估计值进行比较。

[0154] 商业可购的装置任选地可以用来监测治疗。这样的装置包括，例如，可从加利福尼 亚州Rancho Cordova的Volcano™ Therapeutics Inc.获得的SmartWireTM、FlotWireTM和 WaveWireTM，以及可从瑞典Uppsala 的 RADI Medical Systems AB获得的 Pressure Wire®。其它的商购装置将是显而易见的。电穿孔的程度另外或备选地可以使 用电阻抗体层摄影术（“EIT”）或其它电阻抗检测法诸如电阻抗指数直接监测。

[0155] 尽管上文描述了本发明的优选的示例性变体，但是对于本领域的技术人员显而易 见地可以进行各种改变和改进，而不背离本发明。例如，尽管主要描述了变体与脉冲电场组 合使用，但是应该理解，当需要时可以输送任何其它电场。在附上的权利要求中意欲覆盖落 入本发明真正的精神和范围内的所有这样的改变和改进。

Claims (35)

1. 用于肾神经调节的装置，所述装置包括： 导管，所述导管具有螺旋远端部件，所述螺旋远端部件被设置成经皮放置于患者肾动 脉内部， 其中所述螺旋远端部件被设置成与所述肾动脉管壁并列，且 其中所述导管被设置成减少邻近所述肾动脉的肾神经的神经信号传导，和 内部牵引线、设置插入到所述导管内的调节轴、设置放置在所述导管上的定型鞘、或将 多个不同斜度的导管组合形成导管，它们设置用于调整所述螺旋远端部件的斜度。
2. 根据权利要求1所述的装置，其中所述导管被设置成向所述肾神经输送以下至少一 种:低温能量，脉冲电场，热RF电流，非热RF电流，热DC，非热DC，刺激波形，微波，非聚焦超声 和聚焦超声。
3. 根据权利要求2所述的装置，其中，所述聚焦超声包括高强度聚焦超声。
4. 根据权利要求1所述的装置，其中所述导管被设置成以低剖面构型排列，以在血管内 输送至所述肾动脉。
5. 根据权利要求4所述的装置，其中所述导管被设置成一旦位于所述肾动脉内部则主 动膨胀。
6. 根据权利要求4所述的装置，其中所述导管被设置成一旦位于所述肾动脉内部则自 动膨胀。
7. 根据权利要求1所述的装置，其还包括灌注元件，其中所述灌注元件包括多孔的气 球。
8. 根据权利要求1所述的装置，其中所述导管被设置用于灌注或抽吸。
9. 根据权利要求1所述的装置，其中所述导管包括监测至少一种生理参数对肾神经刺 激的反应的元件。
10. 根据权利要求9所述的装置，其中，所述至少一种生理参数包括肾素水平、钠水平、 肾血流或血压。
11. 根据权利要求9所述的装置，其中，所述螺旋远端部件包括设置用于将刺激波形输 送到肾血管系统的至少一个电极。
12. 根据权利要求9所述的装置，其中所述元件选自由多普勒超声传感器、热电偶、压力 传感器以及它们的组合组成的组。
13. 根据权利要求12所述的装置，其中，所述元件包括成像手段。
14. 根据权利要求13所述的装置，其中，所述成像手段包括血管内部超声。
15. 根据权利要求4所述的装置，其中所述螺旋远端部件包括至少一个电极。
16. 根据权利要求15所述的装置，其中，所述至少一个电极包括环形电极。
17. 根据权利要求15所述的装置，其中所述螺旋远端部件被设置成使所述至少一个电 极物理接触所述肾动脉的壁。
18. 根据权利要求15所述的装置，其中所述至少一个电极选自以下组成的组:一个个单 个电极、同一但分节的电极、同一且连续的电极和它们的组合。
19. 根据权利要求15所述的装置，其中，所述至少一个电极为同一且连续的电极，其包 括置于螺旋远端部件上的传导线圈。
20. 根据权利要求15所述的装置，其中所述至少一个电极为同一但是分节的电极，其包 括电连接的一系列单个电极。
21. 根据权利要求15所述的装置，其中所述导管还包括可扩张的定中心元件，其设置成 与所述肾动脉的壁物理接触。
22. 根据权利要求21所述的装置，其中所述可扩张的定中心元件包括膨胀的气球。
23. 根据权利要求22所述的装置，其中，膨胀的气球构造成作为增加阻抗的绝缘体。
24. 根据权利要求21所述的装置，其中所述至少一个电极位于所述可扩张的定中心元 件上，并且设置成与所述肾动脉的壁物理接触。
25. 根据权利要求15所述的装置，其中所述导管包括有导线内腔，并且其中所述至少一 个电极包括第一电极和第二电极，所述第二电极被设置成通过所述导管的导线内腔移动。
26. 根据权利要求25所述的装置，其中所述第二电极设置成以两极方式与所述第一电 极一起应用。
27. 根据权利要求15所述的装置，其中，所述至少一个电极包括设置成提供双极信号的 一个个单个电极或电极组。
28. 根据权利要求15所述的装置，其中所述至少一个电极包括第一电极，并且所述导管 还包括第二电极以确定两极电极对。
29. 根据权利要求15所述的装置，其中所述至少一个电极包括第一动态可控的电极，并 且所述导管还包括多个其它动态可控的电极。
30. 根据权利要求15所述的装置，其还包括电场发生器，其中所述至少一个电极和所述 电场发生器被设置成向肾神经输送刺激电场。
31. 根据权利要求30所述的装置，其中所述至少一个电极和所述电场发生器设置成产 生在肾神经中诱导电融合的脉冲电场。
32. 根据权利要求30所述的装置，其中所述至少一个电极包括作用电极和设置成与患 者外部附着的接地电极，以便设置所述电场发生器和所述作用电极以单极方式将电场输送 到肾神经。
33. 根据权利要求30所述的装置，其中所述电场发生器设置成向肾神经产生热、非脉冲 电场。
34. 根据权利要求33所述的装置，其中所述电场发生器设置成产生和通过所述导管输 送足以导致至少部分肾去神经或至少部分肾神经消融的电场。
35. 根据权利要求21所述的装置，其中，所述导管包括邻近定中心元件设置在导管轴上 的灌输端口或出口。
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