CN105288847A - 通过血管内到外用于脉冲电场神经调控的方法和装置 - Google Patents

通过血管内到外用于脉冲电场神经调控的方法和装置 Download PDF

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CN105288847A
CN105288847A CN201510881802.2A CN201510881802A CN105288847A CN 105288847 A CN105288847 A CN 105288847A CN 201510881802 A CN201510881802 A CN 201510881802A CN 105288847 A CN105288847 A CN 105288847A
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丹尼斯·德马瑞斯
本杰明·J·克拉克
尼古拉斯·扎德诺
埃里克·泰
汉森·吉福特·Iii
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Abstract

方法和装置提供用于通过血管内到外方法用于脉冲电场调控，例如以完成不可逆电穿孔或电融合、坏疽与/或引起细胞凋亡、基因表达的改变、细胞因子上调的变化和目标神经纤维的其它状况。在一些实施例中，该ITEV？PEF系统包括血管内导管，一个或多个电极配置用于血管内到外放置，穿过患者的血管与目标神经纤维接近。在PEF传送前，通过电极从血管内位置经过到血管外位置，相对于一个或多个电极仅位于血管内的血管内PEF系统，可以减小经由电极传送、实现期望神经调控所需的施加电压或能量的幅度。本发明的方法和装置例如可用于调控有助于肾功能的一个或多个目标神经纤维。

Description

通过血管内到外用于脉冲电场神经调控的方法和装置
本申请是申请人为“美敦力AF卢森堡公司”的进入中国国家阶段日期为2008年6月30日的申请号为200680050078.8的发明名称为“通过血管内到外用于脉冲电场神经调控的方法和装置”的专利申请(国际申请日为2006-12-21，国际申请号为PCT/US2006/048822)的分案申请。
通过参考合并
在这个说明书中提及的所有发布和专利申请通过参照并入这里，如同每个单个发布或专利申请通过参照被具体和单独指示加入。
技术领域
本发明涉及用于神经调控的方法和装置。更具体地说，本发明涉及通过血管内到外方法用于取得脉冲电场神经调控的方法和装置。
背景技术
充血性心力衰竭(congestiveheartfailure，CHF)是一种心脏损伤并减小到身体器官的血流时出现的情况。如果血流充分减小，肾功能会损伤，导致体液留置、异常激素分泌和血管收缩加剧。这些结果增加了心脏的工作负荷，并且进一步减小了心脏经过肾和循环系统泵取血流的能力。
逐渐减小的肾灌注被认为是维持CHF的向下螺旋的主要非心源性原因。此外，由这些生理变化引起的体液过载和相关临床症状导致另外的入院、差的生活质量和医疗系统的另外成本。
除了它们在CHF发展中的作用，肾在慢性肾功能衰竭(″CRF″)、终末期肾病(″ESRD″)、高血压(病理高血压)和其它心脏-肾病的发展中起到重要作用。肾的功能能够分成三大类：过滤血液和排泄由身体新陈代谢产生的废物；调节盐、水、电解质和酸碱平衡；和分泌激素以保持重要器官血流。没有适合机能的肾，病人将遭受水置留、减小的尿流和血液和身体中废毒素的累积。这些情况由肾功能减弱或肾衰竭(肾衰竭)引起，并且被认为增加心脏工作负载。在CHF病人中，随着由于功能肾差，体液留置和血液毒素累积，肾衰竭将导致心脏进一步恶化。
在动物模型中，心力衰竭情况导致肾异常高交感兴奋已成立。肾交感神经活动的增加导致为肾供血的血管收缩、肾血液流动减小、水和钠从身体排泄减小和肾素分泌物增加。例如通过去神经支配，减小交感肾神经活动可倒转这些过程。
申请人先前已描述了通过将脉冲电场应用于有助于肾功能的神经纤维，治疗肾紊乱的方法和装置。例如参见2005年5月13日申请的共同未决美国专利申请序号第11/129,765号，和2005年6月25日申请的序号第11/189,563号，两者均通过参考整体并入这里。通过不可逆电穿孔或通过电融合，脉冲电场(″PEF″)可促使肾神经调控，例如去除神经支配。PEF可从位于血管内、血管外、血管内到血管外或其组合的装置传送。如在这里使用的，电融合包括通过暴露于电场引起的相邻细胞的融合。为了电融合的目的，可采用多种方式取得目标相邻细胞之间的接触，例如包括通过介电电泳。在组织中，目标细胞可能已接触，从而有利于电融合。
如在这里使用的，电穿孔和电通透是操纵细胞膜或细胞内装置的方法。例如，例如通过短、高压脉冲，通过引起经过细胞膜的足够电压，可增加细胞膜的多孔性。细胞膜的多孔性范围(例如孔的尺寸和数目)和效应周期(例如暂时或永久)是多种变量的函数，诸如场强、脉冲宽度、任务循环、电场方位、细胞类型或尺寸和其它参数。
当终止相对较低强度的电场或相对较短脉冲宽度(这里定义为“可逆电穿孔”)时，细胞膜孔将通常自发关闭。然而，每个细胞或细胞类型具有临界阀值，超过它，孔不会关闭，使得：孔形成不再可逆；这种结果被定义为“不可逆电穿透”、“不可逆击穿”或“不可逆损伤”。关于这一点，出现由高多孔性导致的细胞膜破裂与/或不可逆化学失衡。这种高多孔性能够是单个大孔与/或多个较小孔的结果。
在一些患者中，当足以促使不可逆电穿孔的PEF应用于有助于肾神经功能的肾神经与/或其它神经纤维时，申请人相信：由PEF引起的去神经支配将导致尿输出增加、血浆肾素水平减小、组织(例如肾)与/或尿儿茶酚胺(例如降肾上腺素)减小、尿钠排泄增加与/或血压得到控制，这会防止或治疗CHF、高血压、肾系统疾病和其它肾或心脏-肾异常。PEF系统能够用于调控输出或输入神经信号，以及输出和输入神经信号的组合。
使用血管内PEF系统用于治疗肾紊乱的潜在挑战是不影响其它细胞地有选择地电穿孔目标细胞。例如，可能期望不可逆地电穿孔沿肾血管或接近肾血管传播的肾神经细胞，但可能不期望损坏组成血管的平滑肌肉细胞。因此，PEF治疗的过度侵蚀过程可能持久地损坏肾血管，但PEF治疗的过度保守过程可能不会取得期望的肾神经调控。
申请人先前已描述了用于监控组织电阻或传导性以确定脉冲电场治疗的效果的方法和装置，例如以确定电穿孔的范围与/或不可逆性的程度。例如参见申请人2005年9月23日申请的共同未决美国专利申请序号第11/233,814号，其通过参考整体并入这里。组织的脉冲电场穿孔导致组织电阻减小和组织传导性增加。如果引起的电穿孔是不可逆的，在脉冲电场停止时，组织电阻和传导性应近似基线水平。然而，如果电穿孔是可逆的，在终止脉冲电场时，电阻和传导性变化应不变。因此，监控目标与/非目标组织的电阻或传导率可用于确定电穿孔的发作和确定电穿孔的类型或程度。此外，监控数据可用于一个或多个手动或自动反馈环以控制电穿孔。
不管是否使用监控技术，为调控目标神经纤维，在目标神经纤维附近建立充分幅度的电场所需的从血管内PEF系统施加的能量或电压可能是对诸如血管壁的平滑肌细胞的非目标组织引导持续损伤的幅度。因此，在特定患者中，利用不伴随引起对非目标组织损伤的一些血管内PEF系统，可以无法实现例如肾去神经支配的期望治疗结果。因此，可能期望提供用于减小在目标组织中实现期望神经调控与/或对目标组织附近的充分幅度引起的电场提高定位所需施加能量或电压的方法和装置。
发明内容
本发明提供了经血管内到外(″ITEV″)方法用于脉冲电场(″PEF″)调控的方法和装置，例如以完成不可逆电穿孔或电融合、坏疽与/或引起细胞凋亡、基因表达的改变、细胞因子上调的变化和目标神经纤维的其它状况。在一些实施例中，该ITEVPEF系统包括血管内导管，具有构造用于经过患者的血管内到外放置接近目标神经纤维的一个或多个电极。在PEF传送前，通过电极从血管内位置经过到血管外位置，相对于一个或多个电极仅位于血管内的血管内PEF系统，可以减小经由电极传送、实现期望神经调控所需的施加电压或能量的幅度。本发明的方法和装置例如可用于调控有助于肾功能的一个或多个神经纤维。
根据期望，脉冲电场参数可改变并按任何组合进行组合。这种参数可包括但不局限于电压、场强、脉冲宽度、脉冲周期、脉冲形状、脉冲数目与/或脉冲之间的间隔(例如，任务循环)等。例如，适合的场强能够高达约10,000V/cm，并且适合的脉冲宽度能够长达1秒。脉冲波的适合形状例如包括AC波型、正弦波、余弦波、正弦和余弦波的组合、DC波型、DC-移动AC波型、RF波型、方波、梯形波、指数衰减波或组合。该场包括至少一个脉冲，并且在许多应用中，场包括多个脉冲。适合的脉冲间隔例如包括小于约10秒的间隔。这些参数被作为适合的实例提供，绝不能认为是限制性的。
附图说明
结合附图进行的下述详细描述，本发明的几个实施例将变得明显，其中：类似标号指类似部件，并且其中：
图1是显示人肾解剖的示意图。
图2是显示关于肾动脉的肾神经的位置的示意细节视图。
图3A和3B是分别显示用于选择性的影响肾神经的电场的方位的示意侧和端视图。
图4A-4D是显示经血管内到外方法用于脉冲电场神经调控的方法和装置的部分采用断面的示意侧视图，具有至少一个电极定位在血管外部的一对电极。
图5是显示经血管内到外方法用于单极脉冲电场神经调节的方法和装置的部分采用断面的示意图。
图6A-6C是显示图5的方法和装置的可选实施例的部分采用断面的示意侧视图，这些方法和装置包括具有位于血管外的第一电极和位于血管内的第二电极的双极电极对。
图7A和7B是显示通过双极电极对用于脉冲电场神经调节的另外的方法和装置的部分采用断面的示意图，双极电极对包括位于血管外的至少一个第一电极和位于血管内的至少一个第二电极。
图8A-8C是示意侧断面视图和部分采用断面的示意侧视图，显示经血管内到外方法用于脉冲电场神经调控的方法和装置，具有每个电极对的两个电极定位在血管外部的至少一个双极电极对。
图9是图8的方法和装置的可选实施例的部分采用断面的示意侧视图。
图10A-10F是包括多对双极电极的图9的方法和装置的可选实施例的部分采用断面的示意侧视图。
图11A-11C是图10的方法和装置的可选实施例的部分采用断面的示意侧视图，包括在血管外放置前，用于电极血管内传送的安全部件。
图12是经血管内到外方法，通过位于血管外的至少一个角度对准、纵向间隔的双极电极对用于脉冲电场神经调节的方法和装置的部分采用断面的示意图。
图13A-13D是沿图12的剖面线A-A的示意横截面视图，显示了通过多对角度对准、纵向间隔ITEV双极电极对用于目标神经纤维的圆周脉冲电场调控的方法和装置，每对位于不同的圆周位置。
图14A-14D是示意侧断面视图和部分采用断面的示意侧视图，显示了经血管内到外方法通过位于血管外的电极用于脉冲电场神经调控的可选方法和装置。
图15A-15C是经血管内到外方法通过位于血管外的电极用于脉冲电场神经调控的其它可选方法和装置的部分采用断面的示意侧视图，以及沿图15A的剖面线的横断面视图。
图16A和16B是图15的方法和装置的可选实施例的示意侧视图。
图17A-17E是经血管内到外方法通过位于血管外的电极的用于脉冲电场神经调节的其它方法和装置的部分采用断面的示意图。
图18A-18D是图17的方法和装置的可选实施例的部分采用断面的示意侧视图。
图19A和19B是用于脉冲电场神经调节的方法和装置的部分采用断面的示意图，包括具有构造用于血管内到外放置的电极的支架。
具体实施方式
A.总述
本发明涉及一种用于神经调控的方法和装置，例如去除神经支配。更具体地说，本发明涉及利用血管内到血管外方法用于实现脉冲电场神经调控的方法和装置。在一些实施例中，该ITEVPEF系统包括血管内导管，具有配置用于穿过患者的血管的血管内到外放置接近目标神经纤维的一个或多个电极。相对于具有仅定位在血管外的一个或多个电极的血管外PEF系统，通过在传送PEF前，电极从血管内位置经过到血管外位置，经电极传送并且取得期望神经调控所需的施加电压或能量的幅度减小。本发明的方法和装置例如可用于调控有助于肾功能的一个或多个目标神经纤维。
本发明的方法和装置可用于调控有助于肾功能的神经纤维，并可以开发任何适合的电信号或场参数，例如将取得期望的神经调控(例如，电穿孔效应)的任何电场。为了更好地理解本发明的设备的结构和使用这种用于肾神经调控和监控设备的方法，研究人体中肾解剖学是有益的。
B.神经调控方法的选定实施例
现在参照图1，人肾解剖包括肾K，其由利用腹主动脉AA连接到心脏的肾动脉RA供应含氧血液。经由肾静脉RV和下腔静脉IVC，脱氧血液从肾流到心脏。图2更详细地说明了肾解剖的一部分。更具体地说，该肾解剖还包括肾神经RN，通常在动脉的动脉外膜内沿肾动脉RA的长度尺寸L纵向延伸。该肾动脉RA具有包围动脉周围并螺旋围绕动脉的角轴的平滑肌细胞SMC。该肾动脉的平滑肌细胞相应地具有长度或更长尺寸，延伸横过(即非平行)肾动脉的长度尺寸。该肾神经和平滑肌细胞的长度尺寸的未对准被定义为“细胞未对准”。
参照图3，该肾神经和平滑肌细胞的细胞不一致可被开发以有选择地影响肾神经细胞，对平滑肌具有减小影响。更具体地说，因为更大细胞要求更低电场强度以超过用于不可逆电穿孔的细胞膜不可逆性阀值电压或能量，本发明的电极的实施例可被构造以使电极产生的至少一部分电场与将影响的细胞的更长尺寸一致或接近它。在具体实施例中，该设备具有电极，其被构造以产生与肾动脉RA的长度尺寸L一致或接近的电场，以影响肾神经RN。通过对准电场，使得：场优选地与细胞的长度方向一致，而不是细胞的直径或径向方向，更低的场强可用于影响目标神经细胞，例如以坏死或融合目标细胞，以引起细胞凋亡、以改变基因表达、改变细胞因子上调与/或引起其它适合的过程。这被期望减小传送给系统的总能量，并减轻在电场中对非目标细胞的影响。
类似地，目标神经上方或下方的组织的长度或更长尺寸是对角的，或者否则关于神经细胞的更长尺寸偏轴(例如，横穿)。因此，除了将PEF与目标细胞的长度或较长尺寸一致，PEF可沿非目标细胞的侧向或较短尺寸传播(即，使得PEF传播至少部分地与非目标平滑肌细胞SMC未对准)。因此，如图3所示，以通常与肾动脉RA的纵向尺寸L对准的传播线Li施加PEF期望优选地导致在目标肾神经的细胞中电穿孔、电融合、去除神经支配或其它神经调控，不会不适当地影响非目标动脉平滑肌细胞SMC。该脉冲电场可沿肾动脉的纵向轴的单个平面传播，或可沿经过0°-360°范围的任何角度段θ沿纵向的方向传播。
例如通过血管内到外(″ITEV″)方法，放置在肾动脉的壁内与/或至少部分穿过肾动脉的壁的PEF系统可传播电场，具有与血管壁的肾神经RN和平滑肌细胞SMC的区域中的动脉的纵向尺寸对准运行的纵向部，使得：动脉的壁保持至少基本完整无缺，同时外部神经细胞被损坏、融合或否则影响。监控元件可用于估计在肾神经中与/或平滑肌细胞中引起的例如电穿孔的程度，以及调节PEF参数以取得期望的效果。
C.神经调控用的系统和另外方法的典型实施例
参照图4，描述本发明的内到外部血管(″ITEV″)PEF系统和方法的实施例。本发明的ITEVPEF系统被构造用于暂时血管内放置和用于一个或多个电极穿过血管，用于血管外放置。此外，系统被构造以将脉冲电场传送给用于神经调控的神经纤维。在一个特定实例中，系统被构造以将脉冲电场传送给有助于肾功能的神经纤维，以取得肾神经调控。为了本发明的目的，血管外应指血管的内膜和介质层外部的任何位置。血管外例如可以包括血管的外膜内或周围的脂肪组织内的位置。
在图4A-D，ITEVPEF系统100包括：具有内腔103的血管内导管102；成型套管104，被构造用于在内腔103内的低轮廓传送和用于从内腔103前进，以穿透患者的血管壁；和第一导线电极106，被构造用于前进穿过套管104的内腔105。该套管104例如可由形状记忆材料(例如镍钛诺)或柔韧、预先形成的弹性材料(例如薄壁不锈钢)制造。
在图4A和4B的实施例中，系统100还包括构造用于内血管定位的第二导线电极108(图4B)。形成双极电极对的导线电极106和108可选地可在所有区域绝缘，除了其远端。该电极被电连接到位于患者外部的脉冲电场发生器50(图4B)。该发生器可以与本发明的任何实施例一起使用，以传送具有期望场参数的PEF。应该理解：在下面描述的PEF传送电极的几个实例可被电连接到发生器，虽然发生器未对于每个实施例明确显示或描述。
如图4A所示，在使用中，导管102可被传送到肾动脉，或它可被传送经过引导导管或其它设备到目标神经组织附近的肾静脉或到任何其它血管(例如，有助于肾功能的目标神经组织)。该导管优选地利用经由皮肤的技术传送，诸如利用经由皮肤的股动脉通路。一旦成型套管104位于患者的血管内，它可前进穿过导管102的内腔103的出口，使得：套管104呈现弯曲或否则角度轮廓。随着套管104进一步前进，它穿透患者的血管壁以定位在血管外部(即至少在外膜内)。然后，第一导线电极106前进穿过套管内腔105，使得：通过血管内到外方法，第一电极106的非绝缘远端区域109a被定位在血管外部。该套管104可被缩回，并且导管102以及套管104可从患者或治疗位置去除。第二导线电极108具有位于血管内的不绝缘远端区109b(在第一电极106的血管外放置之前、期间或以后)，以与第一电极106形成双极电极对(图4B)。
第一电极106优选地包括有源电极，并且第二电极108优选地包括回路电极。然而，应该理解：电极极性可选择地颠倒。电极106和108的非绝缘远端区域109a-b可选地可以沿经过肾动脉RA的横断面平面基本对准。可选地，远端区域109a-b可以纵向间隔开。如关于图3在前面描述的，远端区域109a-b的这种纵向间距例如可以更好地将经电极传送的脉冲电场与肾动脉的纵向尺寸对准，以有利于对非目标平滑肌细胞或其它细胞具有有限影响地调控肾神经。
通过根据期望定位第一和第二电极106和108，由PEF发生器50产生的脉冲电场被传送经过电极106和108，并被传送经过电极的非绝缘远端区域109a-b。该PEF治疗沿肾神经纤维调控直接或间接有助于肾功能的活动(例如去神经支配关于肾功能的神经纤维)。这可以例如通过在神经细胞中的不可逆电穿孔、电融合、坏死与/或引起细胞凋亡、改变基因表示、改变细胞因子上调与/或其它适合的过程实现。在传送PEF治疗后，ITEVPEF系统100可脱离患者，以结束过程。
可以期望：使用ITEVPEF系统100的PEF治疗将减轻CHF1高血压、肾病与/或其它心脏-肾病的临床症状几个月的时期，可能长达6个月或更多。这种时间周期可能足以使身体治愈；例如，这种周期可减小在急性心肌梗死后的CHF发作的危险。可选地，随着症状的重复出现，或以规律的预定间隔，患者可回来找医生重复治疗。
为了去除神经支配或其它方式调控目标神经纤维，ITEVPEF系统100应产生经过纤维的充分强度或幅度的电场，以引起这种去除神经支配或调控。当使用血管内PEF系统时，根据PEF电极的布置和定位，以及患者的生理状态，在目标神经纤维处实现充分幅度的场强所需施加的电压还可能具有充分幅度，以在诸如平滑肌细胞与/或血管壁的非目标组织中引起不期望的持久损伤。可以期望：与当使用具有类似间隔和尺寸的电极的单独血管外装置相比，经血管内到外方法的电极106的血管外定位将减小通过PEF治疗用于去除神经支配或调控所需应用电压(例如肾去除神经支配或调控)。具体地说，电极106在更接近目标神经纤维的血管外放置预期增加了峰值感应电场在目标神经纤维附近的定位性。
如图4C所示，导管102可选地可包括将导管102稳定在患者血管内的可扩张元件101(例如，可膨胀气球)。该可扩张元件101还有利于利用套管104对血管的穿透，以将第一电极106定位在血管外的位置。如图4D所示，第一电极106可包括间隔的双极电极对107a和107b，以避免对血管内第二电极108的需要。该PEF治疗可以通过经过血管外的双极电极对107a-b传送。
该血管外第二电极106可选地可由虚电极代替。例如，传导盐可以经套管104注射进入血管外空间。该传导盐可提供围绕血管周围全部或部分的虚电极，并可以采用双极形式与血管外电极108一起使用。
通过用连接到PEF发生器50和附于患者外部的接地垫代替血管外第二电极108，图4A-D的ITEVPEF系统的实例可选地可采用单极方式使用。图5显示了的可选单极ITEVPEF系统110，包括具有可扩张元件114的导管112，一个或多个类似针的ITEV电极116被连接到可扩张元件。当提供多个针电极116时，它们可围绕/沿可扩张元件114圆周与/或纵向间隔。该系统110还包括接地垫120，其沿患者的外部附于患者的皮肤S(例如，到患者的腰窝、背部或大腿)并被联接到作为回路电极的PEF发生器50。该接地垫120可选地直接位于ITEV电极116侧面，以沿患者的血管(例如沿肾动脉RA)控制PEF治疗。
该可扩张元件114包括构造用于采用低轮廓结构血管内传送到(和收回)目标位置并用于在目标位置扩大为扩张配置的部件或结构。该可扩张元件114例如可包括可膨胀气球、可扩张篮或笼或其它可扩张结构。如在图5中看到，扩张元件114的扩张导致ITEV电极116穿透肾动脉RA的壁，并从血管内位置运动到血管外位置。利用位于血管外并联接到PEF发生器50的ITEV电极116，在单极PEF治疗中，ITEV电极可作为有源电极加电，外部接地垫120用作回路电极。
现在参照图6A-C，描述了ITEVPEF系统110的可选实施例，包括位于血管外的第一电极和位于血管内的第二电极。在图6A-C中，ITEVPEF系统110还包括具有可扩张元件114的导管112，一个或多个ITEV电极116被连接到可扩张元件并构造用于血管内到外传送。系统110还包括位于血管内的血管内第二电极118。在图6A中，第二电极118包括位于导管112的内腔内的导线电极。该导线电极118被联接到PEF发生器50并在位于导管112的远端的远端区域以外的区域绝缘。在图6B中，第二电极118被联接到可扩张元件114远端的导管112的轴上。在图6C中，第二电极118被联接到可扩张元件114近端的导管112的轴上。在使用中，ITEV电极116可包括有源电极；并且第二电极118可包括回路电极或反之亦然。该第二电极118可选地可相对于ITEV电极116纵向间隔，以使PEF治疗与患者的血管的纵向轴对准，如参照图2和3在先前描述的。第二电极118例如可由金属丝缠绕线圈制成。当使用相对较长的电极时，缠绕线圈允许导管112保持期望的柔韧性。
现在参照图7A和7B，描述了通过具有位于血管外的第一电极和位于血管内的第二电极的双极电极对，用于脉冲电场调控的另外的方法和装置。图7A和7B更具体地显示了ITEVPET系统150，包括导管152和可包括可膨胀气球或可扩张金属笼的可扩张元件154。该系统150还包括联接到导管152的一个或多个ITEV针电极156，显示在可扩张元件154的近端；和回路电极157，显示联接到可扩张元件154的远端的导管152的轴。另外，该系统包括保护鞘158，具有导管152可被定位用于经由皮肤前进与/或缩回地定位其中的内腔159。
在图7A和7B中，ITEV电极156的远端区域侧向延伸经过但未被连接到至少一部分可扩张元件154。这与具有直接连接到可扩张元件的ITEV电极的图4-6的先前描述的ITEVPEF系统形成对比。通过将ITEV电极156从可扩张元件154分离，图7A和7B的系统150可简化制造与/或提高扩张可靠性。
如图7A所示，该导管152和保护鞘158可前进到患者的血管内的位置(例如在导线G上方的肾动脉RA内)。一旦就位，该鞘158可相对于导管152缩回与/或导管152可相对于鞘158前进，使得：该可扩展元件154、ITEV电极156和回路电极157被定位在保护鞘158的远端。如图7B所示，可扩张元件154然后扩张，使得：ITEV针电极156穿透血管壁，并通过ITEV方法定位在血管外部。一旦电极156被定位在血管外部，PEF治疗可在ITEV电极156和回路电极157之间进行。例如，PEF治疗能够调控与/或去除神经支配有助于肾功能的神经纤维。在完成PEF治疗时，可扩展元件154可塌陷，并且鞘158可相对于导管152前进，使得：ITEV电极156从血管壁去除。该系统150然后从患者取出以完成过程。
现在参照图8A-C，描述了用于脉冲电场神经调控用的方法和装置，其利用血管内到外方法，使用每对的两个电极定位在血管外部的一个或多个双极电极对。这种ITEVPEF系统170的一个实例包括导管或鞘172，具有被构造用于前进到鞘内的血管内位置的成型ITEV双极针电极174a和174b。该电极174a-b可具有形状记忆属性(例如可由诸如镍钛诺的形状记忆合金制造)并可在其远端区域以外的位置处绝缘。如图8B所示，在电极174a-b前进到鞘172的远端位置(例如，通过鞘的缩回)时，电极174a-b呈现其预选形成的形状，并穿透患者的血管壁，显示为肾动脉RA，使得：通过ITEV方法，电极174a-b的远端区域被定位在血管外部。如将很明显，电极174a和174b可相对于彼此纵向间隔，以更好地将PEF治疗与患者的血管的纵向尺寸对准。此外，虽然电极显示径向间隔开约180度，应该理解：电极可选地可以任何期望的径向分隔间隔(或没有)。
图8C显示了ITEVPEF系统170的另一实例，包括纵向间隔的多对ITEV电极。该系统170例如能够包括第一双极电极对174a和174b和第二双极电极对174a′和174b′。根据期望，在不同圆周位置处或具有不同纵向间距的另外的双极电极对可用在其它实例中。
一旦适合地定位，PEF治疗可被传送经过电极174以实现期望的神经调控。在完成PEF治疗时，该针电极174可相对于鞘172缩回，与/或鞘172可相对于电极174前进，使得：电极被从患者的血管壁去除，并且同轴返回进入鞘内的限制缩回结构中。该ITEVPEF系统170然后远离患者以完成过程。
参照图9，ITEVPEF系统170的可选实施例被描述包括具有可扩张元件177的导管176。该可扩张元件177用作引导器，当扩大时，其指向或强制电极174经过血管壁。更具体地说，在它已被扩张后，通过沿可扩张元件177使电极174前进，该可扩张元件177能够指向电极174穿过血管壁。可选地，当可扩张元件177采用减小轮廓结构时，通过使电极174前进经过可扩张元件177，并且然后可扩张元件177扩张以强制电极174经过血管壁，该可扩张元件177能够使电极174经过血管壁。
图10A-F显示了包括多对双极电极的ITEVPEF系统170的另一可选实施例。在图10A和10B中，该ITEV电极174已由ITEV电极载体178代替。每个ITEV电极载体178包括多个电极179。例如，每个电极载体178可包括一对电绝缘双极电极179。可选地，每个载体178可包括公共极性的多个电极179。该电极179包括变尖点、针或其它升高件，用于穿透患者血管的壁。如图10A所示，电极179采用低轮廓结构可被传送到刺激位置，例如穿过或在鞘172内。如在图10B中，通过扩张可扩张元件177，电极179然后可通过ITEV方法定位在血管外。
如图10C和10D所示，电极载体178可选地可被联接到在轴环175处的可扩张元件177远端的导管176。该轴环175可被滑动地附于导管176与/或可纵向受限。通过ITEV方法，将载体附于导管的期望优点是很好地控制电极的血管外定位。
如图10E所示，电极载体178可选地可螺旋围绕可扩张元件177。载体178可选择性包括位于多个圆周位置处的几个电极179以有利于更多的圆周PEF治疗。电极载体178优选地彼此电绝缘。例如，载体178可在所有区域绝缘，除了在电极179处。
如图10F所示，该系统170可选地可包括螺旋围绕可扩张元件177的单个电极载体178。沿单一载体的多个电极可能具有公共极性，与/或可彼此电隔离，和具有不同极性以形成双极电极对。根据期望，电极179可被定位在多个圆周位置。
图11A-C显示了ITEVPEF系统170的其它实例，包括在将电极放置在血管外前，有利于电极179在血管内传送的安全件。在图11A-C的实施例中，采用有利于电极179相对于各自载体178的旋转的方式，电极179被联接到电极载体178。例如，电极179可在枢轴180处联接到载体178，其可包括旋转承载表面。此外，电极179包括与可扩展元件177共同作用的延长部182，以在减小传送和缩回轮廓与适合用于电极的ITEV传送的扩展轮廓之间选择性地旋转电极179。电极179可选地偏向减小的轮廓，例如通过弹簧机构。在电极ITEV放置在治疗位置处前的安全特性，该减小的轮廓用作减小血管组织的无意穿孔的危险。
如图11A所示，在传送到血管内治疗位置(例如或在鞘172内)期间，电极179平坦地放置接近或靠着电极载体178。在传送期间，电极179被定位在可扩张元件177的近端。一旦定位在血管内，电极179被扩张，使得：通过相对于电极载体178缩回可扩展元件177，其尖部径向外部指向。如图11B所示，可扩张元件177的缩回导致它结合电极179的延长部182，使得：电极179围绕枢轴180旋转到适合电极179的ITEV传送的扩张结构。如图11C所示，可扩张元件177然后扩张，使得：通过ITEV方法，电极179强制穿过血管壁。ITEVPEF治疗然后可根据期望进行。在完成治疗时，可扩张元件177和电极179被返回到减小的轮廓结构，用于从患者取回。
现在参照图12，描述了通过内到外血管方法，通过将至少一个角度对准、纵向间隔双极电极对定位在血管外部的用于脉冲电场神经调控的方法和装置。图12更具体地显示了ITEVPEF系统200的实例，包括具有可扩张元件204的导管202，至少一对纵向间隔双极针电极206a和206b。该针电极206a-b沿可扩张件被定位在基本相同的角位置(在图12中，该系统显示包括在不同圆周位置处定位的两对纵向间隔、角度对准双极电极206a-b)。如先前描述，纵向间隔双极电极206a-b的角度对准可将PEF治疗与目标神经纤维的纵向轴对准。针电极206的双极对可包括任何期望的纵向间隔，例如电极可包括范围约0.5-10mm的间距。
使用已知的经由皮肤的技术，该ITEVPEF系统200可被传送到血管内治疗位置，诸如肾动脉RA内的位置。例如，该系统200可被前进经过利用导管202的内腔203定位的导线G，其可被前进穿过/在引导导管或鞘210中。一旦位于治疗位置，扩张件204被扩张以使双极针电极206强制穿过血管壁，使得：利用ITEV方法，电极206的端部被定位在血管外部。通过(a)使气球膨胀，(b)在将元件204定位在鞘210的远端后，自扩张篮或笼，与/或(c)通过多种推/拉与/或张力/压缩技术机械扩张篮或笼，例如可扩张扩张元件204。
使用ITEV技术定位电极206将电极放置在更接近有助于肾功能的目标神经纤维。如前讨论，肾神经可定位在肾动脉的外膜与/或在直接包围肾动脉的组织中。与包含定位在血管内的电极的PEF系统相比，电极的这种ITEV定位以及双极电极对的选定角度对准可减小取得期望神经调控所需的能量要求。
电极206优选地具有足够小的口径，以安全经过肾动脉RA的壁，没有明显的出血危险、血管壁损伤等。例如，电极可采用小于约23标准的口径。此外，电极可以是实心的，或可以包括一个或多个内腔。当利用内腔，针电极可被构造用于药剂的灌输，或者提高期望的神经效果(例如在PEF治疗期间盐水注射可用于局部提高传导率)或提供保护效果(例如，冷却剂可被注射以保护非目标组织)。
针电极206还可沿其整个长度导电，或可沿其长度的至少一部分绝缘。例如，针电极206能够在其远端以外的位置绝缘。沿电极206的部分长度的绝缘可减小脉冲电场治疗不期望地传送到非目标组织，例如内膜或到患者的血管的介质。在电极的ITEV定位期间，这种绝缘电极优选地包括足以将电极的非绝缘部放置在血管外部的至少在血管外膜内的位置处。
现在参照图13A-D，描述了通过多对角度对准、纵向间隔ITEV双极电极对，用于目标神经纤维的圆周脉冲电场调控的方法和装置，其中：每个电极对定位在不同的圆周位置处。图13A-D显示了沿图12的剖面线A-A的ITEVPEF系统200的几个实例。在图13A中，ITEVPEF系统200包括如在图12中圆周定位离开约180度的两对角度对准、纵向间隔双极电极206。在图13B中，该系统200包括三对间隔开约120度的三对这种双极电极。在图13C中，该系统200包括约间隔开90度的四个对，并在图13D中，该系统200包括间隔开约45度的8对。如将明显，可提供任何期望数目的电极对。此外，虽然在图13A-D中显示的电极对已被相同的圆周间隔，它们可选地可以以任何其它期望的间隔圆周间隔，包括任何其它的期望不相同圆周间隔。
如在图13A-D中的电力线L所示，由PEF治疗影响的组织区传送经过每个双极电极对，例如经历期望神经调控的组织区域，被限制到治疗位置的窄圆周段。提供多对双极ITEV电极对206可提供一种更圆周的治疗。如图13D所示，增加额外对的ITEV双极电极206最终导致圆周影响段重叠，从而提供完整的圆周治疗。在一些情况中，可以期望提供完整的圆周治疗，同时在其它情况中，可期望提供小于整个圆周的治疗。该医疗专业人员可提供任何期望水平的圆周治疗与/或可以使用任何期望数目的圆周间隔的双极电极对。对于患者血管的另一圆周纵向段的治疗，通过塌陷扩张元件204、围绕其纵向轴旋转导管202期望的量并且然后重新扩张扩张元件204以将电极对206重新定位在血管外，可以取得沿患者的血管的纵向段的圆周PEF治疗。根据期望，这个过程可以在单个纵向位置处重复。
图14A和14B显示了包括另外的ITEVPEF系统300，包括具有外鞘304、导线管306和无创伤的鼻锥308的导管302。该导线管302被联接到并延伸经过或与无创伤的鼻锥308的内腔309连通。该系统300还包括：联接到其远端区域处的鼻锥308的多个近端定向ITEV针电极310；和围绕导线管306同轴定位的推动管312。该推动管312可选地具有可能相对硬与/或辐射透不过的向外展开的尖部314。利用形成有或在导线管306内的电接点，电极310可联接到PEF发生器50(例如，利用在导线管的外径上或接近导线管的外径的金属编织、线圈或线)。电极310可物理接触这些电接点以有利于PEF治疗的传送。在一些实施例中，如在图14B中，向外展开的尖部314通过接触电极完成电路。
图14A显示了采用减小传送和缩回结构的系统300，电极310位于鞘304内。当血管内放置在治疗位置时，鞘304缩回与/或导线管306前进，使得：电极310脱离鞘304。电极310优选地由抑制变形并在变形时施加恢复力的弹性材料制造。此外，采用偏置电极310到图14A中显示的减小轮廓的方式，电极310优选地被联接到鼻锥308。
如图14B所示，当导管302被定位在治疗位置(例如，在肾动脉RA内)处时，推动管312相对于导线管306前进，使得：扩张尖端314结合并使电极310径向向外弹性变形。利用ITEV方法，该电极310穿透血管以将电极的尖部定位在血管外部。在电极310的变形后，该导管302可选地可缩回以将电极与患者的血管结合并将电极放置在血管外部。PEF治疗然后前进以取得期望的神经调控。在完成治疗时，推动管312相对于导线管306和电极310缩回。该导线管306轻微前进以从血管壁释放电极310。由电极310提供的恢复力将电极310返回到减小的静止轮廓。该鞘304然后可相对于导线管306前进，使得：如图16A所示，针电极310被再次定位在鞘304内，用于缩回和脱离患者。
在图14A和14B的装置的另外或可选实施例中，针电极310可由针电极可前进经过的针外壳代替。该针外壳被扩大以接触血管壁，并且针电极然后被前进经过血管壁。这种前进可通过多种机构装置实现。例如，推动管相对于导线管、鼻锥与/或针外壳经过特定位置的前进可释放使针前进的弹簧负载部件。
图14C和14D显示了包括一个或多个纵向间隔对双极电极的ITEVPEF系统300的可选实施例。在图14C和14D中，针电极310a被联接到鼻锥308；并且针电极310b被联接到第一推动管312a的第一向外展开尖部314a的近端区域。该系统300还包括具有第二向外展开尖部314b的第二推动管312b。该第二推动管312b同轴地放置在第一推动管312a周围。
电极310a和310b形成一个或多个纵向间隔对的双极电极。例如，电极310a可包括有源电极；并且电极310b包括回路电极，或反之亦然。如图14C看出，电极可在鞘304内传送。如图14D所示，一旦被定位在治疗位置，该鞘304可缩回，并且利用ITEV方法，电极310可定位在血管外部。具体地说，第一推动管312a可相对于导线管306前进，使得：第一张开尖部314a撞击在上面并且使针电极310a变形。这使电极310a推动穿过血管壁。类似地，第二推动管312b可相对于第一推动管312a前进，使得：第二张开尖部314b撞击在上面并且使针电极310b变形。这种机构推动电极310b穿过血管壁。在图14C和14D的实施例中，向外展开尖部314包括提供逐渐转换用于使电极310变形的远端轮廓。
图15A-C显示了包括导管322的ITEVPEF系统320的实例，具有：(a)在近端侧端口325处终止的多个近端电极内腔324；(a)在远端侧端口327处终止的多个远端电极内腔326；和(c)导线内腔323。该导管322优选地包括相同数目的近和远端电极内腔。该系统320还包括：可前进穿过近端电极内腔324的近端针电极328；和可前进穿过远端电极内腔326的针电极329。
如图15A所示，经内腔323，该导管322可前进经过导线321到患者的血管内的治疗位置(例如，到患者的肾动脉RA内的治疗位置)。在血管内传送期间，电极328和329被定位，使得：其非绝缘和变尖远端区域分别位于内腔324和326内。一旦定位在治疗位置处，医疗人员可以使电极前进经过位于患者外的其近端区域。如图15B所示，这种前进导致电极326和329的远端区域分别从侧端口325和327出来，并穿透患者的血管壁，使得：通过ITEV方法，电极被定位在血管外部。
由于有源电极和远端电极329能够用作回路电极，该近端电极328能够被连接到PEF发生器50。采用这种方式，近端和远端电极形成将PEF治疗与患者的血管的纵向轴或方向对准的双极电极对。如将很明显，远端电极329可选地可包括有源电极，并且该近端电极328可包括回路电极。此外，该近端与/或远端电极可同时包括有源和回路电极。根据期望，可以使用有源和远端电极的任何组合。
当电极328和329被定位在血管外部时，PEF治疗可前进以实现期望的神经调控。在完成PEF治疗后，电极可缩回在内腔324和326内。该导管322以及导线321然后可脱离患者以完成过程。另外或可选地，该导管可被重新定位以在其它治疗位置提供PEF治疗。
图16A和16B显示ITEVPEF系统320的可选实施例。在图16A中，该系统300的导管322还包括可扩张中心元件330，其包括可膨胀气球或可扩张篮或笼。在使用中，中心元件330可在布置针电极328和329前扩张，以使导管322位于患者的血管内(例如，在肾动脉RA)的中心。将导管322置于中心预期有利于将所有针电极传送到患者的血管内/外的期望深度(例如，以将所有针电极传送到相同深度)。
在图16A中，所示中心元件330被定位在近端侧端口325和远侧端口327之间，即在近端和远端电极的传送位置之间。然而，应该理解：中心元件330另外或可选地可定位在沿导管322的长度的不同位置或多个位置处(例如，在侧端口325近端的位置与/或在侧端口327远端的位置)。在图16B中，该系统320显示包括：位于近端侧端口325的近端的第一中心元件330a；和位置远端侧端口327的远端的第二中心元件330b。
现在，参照图17A-E，描述了使用一个或多个海波管的ITEVPEF系统350。在图17A和17B的实施例中，ITEVPEF系统350包括：具有外部鞘354的导管352；外轴356：具有多个远端延长部359的海波管358；和具有导块362的内轴360。该内轴360在防止损伤的尖部364处终止；并且导线内腔优选地延伸经过内轴和防止损伤的尖部。该海波管358近端被连接到外部轴356；并且外部轴356同轴地定位在内轴360上方。
该海波管358能够具有可通过切除海波管的部分制造的延长部359。该海波管358可由诸如金属合金或铂的传导材料制成，或海波管可包括相对非传导的材料。该延长部359可选择性绝缘与/或非绝缘；并且它们可以电联接到PEF发生器50，以提供一个或多个延长电极。该延长电极可例如被蚀刻在海波管和其它延长部上，例如通过金属沉积过程。用于能量传送的电接点可暴露于绝缘延长部359的尖部处；可选地，非绝缘接点可延伸经过延长部的全部或部分长度。此外，当海波管由传导材料制成时，该整个海波管358可包括电极。
该延长电极359可具有共同极性或可具有不同极性。当具有不同极性时，PEF治疗可采用双极方式以传送经过电极。当具有公共极性时，电极可采用单极方式，例如具有外部接接地垫。可选地，导管352可选地可包括沿其长度的相反极性的一个或多个另外的电极，其可采用双极方式与海波管358的延长电极359一起使用。在一个实施例中，外部轴356包括沿其长度的第二海波管，具有用作相反极性的另外电极的延长电极，并可用于形成间隔双极电极对，用于PEF治疗的传送。
如图17A所示，使用已知的经由皮肤的技术(例如，通过引导导管)，该导管352可前进到患者的血管内的治疗位置，诸如肾动脉RA内的治疗地点。一旦适合定位，外部鞘354可缩回以暴露海波管358；并且然后外部轴356可相对于内轴360前进以抑制引导块362。如图17B所示，随着外轴354相对于内轴360前进，该导块362采用弹性或塑性方式提供使延长部359逐渐变形的渐缩变换。这种变形将延长部359径向向外指向以detone延长电极。外轴的连续前进导致延长电极以穿透血管壁并通过ITEV方法定位在血管外部。利用定位在血管外部的延长电极359，PEF治疗可继续。
在完成PEF治疗时，可扩展元件359可靠着外轴346再次塌陷，用于系统350从患者收回。如果延长部359的变形包括弹性变形，外部轴356可相对于肾动脉RA的壁缩回以使延长部从壁收回。该延长部359然后将返回到图17A的静止结构。如果变形是塑性的，通过使外部鞘354或引导导管在外部轴356上前进，然后延长部359例如可倒塌，使得：鞘354邻接延长部359的底部。然后，该外轴356可被缩回，同时鞘354保持相对于外轴静止或前进，以在鞘354内使延长部359倒塌，用于从患者收回系统350。
如图17C和17D所示，ITEVPEF系统350可选地可包括一个或多个纵向间隔对ITEV电极。在图17C和17D中，海波管358包括远端延长部359a和近端延长部359b。该远端延长部359a可采用先前描述的方式被布置在血管外部。对于近端延长部359a的ITEV布置，该系统350还包括近端推动管355，具有用于使近端延长部359b变形的远端定向导块362′。该推动管355同轴地布置在外轴356上方，但在外鞘354内。如图17D所示，该推动管355可相对于外轴356前进，以使近端延长部359b变形，并且通过ITEV方法将延长电极定位在血管外部。海波管358的近端和远端延长电极形成一个或多个纵向间隔双极电极对。
在图17E中，ITEVPEF系统350还包括远端延长部359a和近端延长部359b。然而，在图17E的实施例中，近端和远端延长部都被远端定向，远端延长部359a具有比近端延长部359b更大的长度。在延长部布置在血管外部期间，远端延长部359a的另外长度导致远端延长部比近端延长部359b更远地穿透患者的血管的壁。采用这种方式，当布置在血管外部时，近端和远端延长359a-b彼此纵向间隔开。在完成血管外PEF治疗后，近端和远端延长部359a-b的远端方位有利于延长部倒塌并缩回。该外轴356可被缩回，同时鞘354保持相对于外轴静止或前进，以在鞘354内使延长部359倒塌，用于从患者收回系统350。
虽然图17A-E中所示的ITEV系统350的几个实例显示了经由导块362布置ITEV延长部电极359，应该理解：电极可通过多种可选技术布置。例如，诸如拉线的推/拉机构可用于使海波延长部变形。可选地，可以使用压力或真空槽。海波管与/或海波管延长电极的排列可选地可利用单个布置机构布置。
参照图18A-D，描述了ITEVPEF系统350的可选实施例。在图18A-D中，导块362已由可选的布置机构代替，包括至少一个可扩张部件，诸如可膨胀气球366。此外，海波管358已由具有延长部359的类似支架的元件370代替。如将很明显，气球366可选地可与海波管358组合使用，与/或类似支架的元件370可选地可与导块362组合使用。
对于海波管358，该支架类似元件370可完全导电，并可用作单一电极。可选地，支架类似元件370可由相对绝缘材料制造，具有蚀刻或沉积在元件上与/或其延长部的电极接点。可以提供多种电极结构。此外，可以提供多重元件370(或海波管358和元件370的组合)。此外或作为图18所示的布置机构的选择方案，延长部359可通过其它布置机构布置，诸如推/拉机构(例如接线)或压力/真空槽。
如在图18A和18B的实施例所示，该系统350可定位在治疗位置，并且联接到内轴360的气球366可膨胀与血管壁接触。如图18A所示，该膨胀气球366使系统350在血管内处于中心，并且在延长电极的ITEV放置期间，提供平滑过渡的渐缩引导通路，用于类似支架元件370的延长部359的变形。如图18B所示，该外轴356可相对于内轴360前进，使得：延长部359开始在气球附近变形，并被径向向外定向。这种变形可选地可利用诸如拉线的另外布置机构辅助，以开始延长部359的变形。外轴356相对于内轴的连续前进导致延长部359穿透血管壁使得：利用ITEV方法，延长电极359的端部被定位在血管外部。
如图18C所示，类似支架元件370可包括纵向间隔延长部359a和359b以提供纵向间隔双极电极对。在图18C中，内轴360包括远端和近端可扩张元件，显示为远端气球366a和近端气球366b。该支架类似元件370位于近端和远端气球之间，延伸部359a和359b分别重叠远端和近端气球366a-b。这种重叠消除了对图18A和18B中所示的外轴356的需要。利用可膨胀气球366取得了延长电极359a-b的ITEV放置。
如图18D所示，具有近端与/或远端延长部359的支架类似元件370被定位在可扩张元件上方，诸如可膨胀气球366。该可扩张元件370近端与/或远端可被联接到轴360(例如，在远端轴环368a和近端轴环368b)。在气球366扩张期间，至少一个轴环368a或368b滑动地联接到轴360以有利于可扩张元件370的扩张。对于图18C的实施例，可扩张元件370相对于气球366的定位消除了对外轴的需要。而且，通过膨胀气球366取得了延长电极的ITEV放置。
现在参照图19A和19B，描述包括可扩张支架的可选ITEVPEF400系统。该ITEVPEF系统400包括支架402，具有被框架以在支架扩张时穿透患者的血管壁的延长部404。该延长部404可以是形成纵向间隔双极电极对的近端和远端延长部。另外，延长部404能够被电联接到PEF发生器50，并用作用于PEF治疗传送的血管外电极。
如图19A所示，采用减小的轮廓结构，支架402可被传送到血管内治疗位置，诸如肾动脉RA内的地点。在前进和布置在治疗位置期间，该支架402例如可定位在传送和布置导管上，诸如气球导管410。该导管410可(暂时)将支架电联接到PEF发生器。如图19B所示，当支架402被适合地定位在治疗位置时，它可被布置以接触血管壁(例如通过布置导管)，使得：延长部404穿透血管壁。通过ITEV方法，这相应地将延长电极定位在血管外部。PEF治疗然后可继续下去，并且完成时，导管410可倒塌并从患者去除。
该系统400有利于在随后的时刻重复PEF治疗。例如，通过暂时电重新联接导管410或一些其它电联接元件到支架402，该系统400能够根据期望重复PEF治疗。当用于实现肾去除神经支配时，当肾的神经分布明显时，这种反复治疗例如可重复。
虽然上面描述了本发明的优选说明性变形，在不背离本发明的情况下，本领域的技术人员可对本发明进行多种变动和修改。例如，虽然变型主要结合脉冲电场使用描述，应该理解：根据期望可以传送任何其它电场。在附带权利要求中，期望覆盖落入本发明的真实精神和范围内的所有这种变化和修改。

Claims (14)

1.通过血管内到血管外方法用于电场神经调控的装置，所述装置包括：
电场发生器；和
电联接到电场发生器的至少一个电极，通过血管内到血管外方法，所述电极被配置用于血管内传送和血管外放置，
其中：所述电极被配置用于电场的血管外传送以调控有助于肾功能的一个或多个目标神经纤维，
其中：所述装置被配置用于药剂的血管外输注。
2.根据权利要求1所述的装置，其中：
所述装置被配置用于改进神经调控或提供保护效果的药剂的血管外输注。
3.根据权利要求1所述的装置，还包括：
配置用于血管内传送的穿透元件，所述穿透元件被配置以从血管内穿透患者的血管壁。
4.根据权利要求3所述的装置，其中：
所述电极被配置用于经过利用穿透元件产生的壁穿孔的血管外放置。
5.根据权利要求3所述的装置，其中：
所述电极包括穿透元件。
6.根据权利要求3所述的装置，其中：
所述穿透元件包括针或套管。
7.根据权利要求6所述的装置，其中：
所述电极被配置用于穿过针的内腔的血管外放置。
8.根据前述权利要求中的任一项所述的装置，其中：
所述电极包括一个或多个内腔。
9.根据权利要求8所述的装置，其中：
所述电极被配置用于药剂的灌输，所述药剂提高期望的神经调控效果或提供保护效果。
10.根据权利要求9所述的装置，其中：
灌输的药剂是盐水或冷却剂。
11.根据权利要求1所述的装置，其中：
所述电极被联接到导管。
12.根据权利要求11所述的装置，其中：
所述电极被联接到所述导管的可扩张元件。
13.根据权利要求1所述的装置，其中：
所述电极被配置用于经由导管传送。
14.根据权利要求11至13中的任一项所述的装置，其中：
所述导管包括近端部分和远端部分，
其中，所述近端部分被配置用于在神经调控过程中位于患者外部，并且，
其中，所述远端部分被配置用于在神经调控过程中位于患者内部。
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