CN107157576A - 用于人类患者的处理的肾神经调节系统 - Google Patents

用于人类患者的处理的肾神经调节系统 Download PDF

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CN107157576A
CN107157576A CN201710406987.0A CN201710406987A CN107157576A CN 107157576 A CN107157576 A CN 107157576A CN 201710406987 A CN201710406987 A CN 201710406987A CN 107157576 A CN107157576 A CN 107157576A
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renal
helical structure
conduit
seal wire
nerve
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CN107157576B (zh
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W·W·常
J·加什加里安
K·莫奇
L·里韦拉
S·幸
D·H·特兰
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Abstract

本文公开了用于通过血管内通路实现肾神经调节的导管设备、系统和方法。本发明的技术的一个方面例如涉及一种构造成递送至肾血管的具有多电极阵列的处理装置。该阵列能在递送或低轮廓状态(例如，大体上直的形状)和部署状态(例如，径向膨胀的大体上螺旋/螺旋状的形状)之间选择性地转变。多电极阵列尺寸设计和成形为使得当阵列处于部署(例如，螺旋/螺旋状)状态时电极或能量递送元件接触肾血管的内壁。电极或能量递送元件被构造成用于直接和/或间接施加热能和/或电能以加热或以其它方式电气地调节有助于肾功能的神经纤维。

Description

用于人类患者的处理的肾神经调节系统
本申请是国际申请号为PCT/US2013/030207、中国申请号为201380024501.7、申请日为2013年3月11日、发明名称为“用于肾神经调节的多电极导管组件及相关联的系统和方法”的申请的分案申请。
相关申请的交叉引用
本申请要求提交于2012年5月11日的美国临时专利申请No.61/646,218的权益和优先权，该申请以引用方式全文并入本文中。
以引用方式并入的附加申请
下列申请也以引用方式全文并入本文中：
提交于2011年10月25日的美国专利申请No.13/281,360；
提交于2011年10月25日的美国专利申请No.13/281,361；以及
提交于2011年10月25日的美国专利申请No.13/281,395。
因此，在这些申请中公开的实施例的部件和特征可与本申请中公开的各种部件和特征结合。
技术领域
本发明的技术整体涉及肾神经调节及相关联的系统和方法。特别地，若干实施例涉及用于血管内肾神经调节的多电极射频(RF)消融导管组件及相关联的系统和方法。
背景技术
交感神经系统(SNS)是通常与应激反应相关联的主要无意识的身体控制系统。SNS的纤维刺激人体的几乎每个器官系统中的组织并可影响诸如瞳孔直径、肠道动力和尿排出量的特性。这种调节可在维持内环境稳定或使身体准备好快速响应于环境因素方面具有自适应效用。然而，SNS的慢性激活是一种能促进许多疾病状态的进展的常见适应不良反应。特别地，肾SNS的过度激活已在经验上和在人体中被确认为是对高血压、容量超负荷状态(例如，心力衰竭)和进展性肾病的复杂的发病机制的可能的促进因素。例如，放射性示踪剂稀释已证明在患有原发性高血压的患者中具有增加的肾去甲肾上腺素("NE")溢出率。
心肾交感神经过度活动可能在患有心力衰竭的患者中尤其显著。例如，在这些患者中经常发现从心脏和肾到血浆的超常NE溢出。升高的SNS激活常常表现为慢性和终末期肾病。在患有终末期肾病的患者中，高于中值的NE血浆水平已证明是心血管疾病和一些死因的预示。这对患有糖尿病肾病或造影剂肾病的患者来说同样如此。证据显示，源自患病的肾感觉传入信号是引发和维持升高的中枢交感流出的主要原因。
支配肾的交感神经终止于血管、肾小球旁器和肾小管中。肾交感神经的刺激可造成肾素释放增加，钠(Na+)重吸收增加和肾血流减少。肾功能的这些神经调节组成部分在表征为交感紧张升高的疾病状态中受到显著刺激，并且可能有助于高血压患者血压升高。作为肾交感传出刺激的结果，肾血流和肾小球滤过率的降低似乎是心肾综合征(即，作为慢性心力衰竭的进展性并发症的肾功能障碍)中肾功能丧失的基础。阻止肾传出交感刺激结果的药理学策略包括中枢作用的交感神经阻滞药、β-阻滞剂(旨在减少肾素释放)、血管紧张素转换酶抑制剂和受体阻滞剂(旨在阻滞肾素释放后的血管紧张素II作用和醛固酮激活)、以及利尿剂(旨在抵消肾交感介导的水钠潴留)。然而，这些药理学策略有很大局限性，包括药效有限、依从性问题、副作用及其它。最近，通过将能量场施加到肾血管中的目标部位(例如，通过RF消融)而降低交感神经活性的血管内装置已经显示可以降低顽固性高血压患者的血压。
附图说明
参照附图可以更好地理解本公开的许多方面。附图中的部件未必按比例绘制。相反，重点在于清楚地说明本公开的原理。此外，部件在某些视图中可显示为透明的，仅仅是为了清楚示出起见，而不是为了表明所示部件必然是透明的。
图1是根据本发明的技术的实施例构造的神经调节系统的局部示意图。
图2示出利用根据本发明的技术的实施例构造的多电极导管调节肾神经。
图3A是根据本发明的技术的实施例在患者体外处于递送状态(例如，低轮廓或收缩构型)的具有治疗组件或处理部段的导管的远端部分的侧视图。
图3B是在患者体外处于部署状态(例如，膨胀构型)的图3A的导管的远端部分的透视图。
图4是图3A的处理装置的一部分的放大视图。
图5是根据本发明的技术的实施例构造的加载工具的局部示意性侧视图。
图6是概念图，示出了交感神经系统和脑经由交感神经系统与身体的通信方法。
图7是放大的解剖图，示出了支配左肾以形成左肾动脉周围的肾丛的神经。
图8A和图8B分别是解剖图和概念图，示出了包括脑和肾的人体以及在脑和肾之间的神经传出和传入通信。
图9A和图9B是解剖图，分别示出了人体的动脉系统和静脉系统。
具体实施方式
本发明的技术涉及用于通过经皮、穿腔、血管内通路实现电诱导和/或热诱导的肾神经调节(即，使支配肾的神经纤维迟钝或失活，或者说是使其功能完全或部分地减少)的设备、系统和方法。特别地，本发明的技术的实施例涉及导管和导管组件，其具有多电极阵列并且能够在递送或薄型状态(例如，大体上平直的形状)与部署状态(例如，径向膨胀的大体上螺旋的形状)之间移动。包括多电极阵列的电极或能量递送元件被构造成在沿着经皮穿腔路径(例如，股动脉穿刺、髂动脉和主动脉、桡动脉、或另一合适的血管内路径)经由导管被推进后将能量(例如电能、RF能、脉冲电能、热能)递送至肾动脉。携带多电极阵列的导管或导管组件尺寸设计和成形为使得当导管在肾动脉内处于部署(例如，螺旋的)状态时电极或能量递送元件接触肾动脉的内壁。此外，携带阵列的导管的部署部分的螺旋形状允许血液流过螺旋，这预计在能量递送元件激活期间有助于防止肾动脉的闭塞。此外，阵列内部或周围的血流可冷却相关联的能量递送元件和/或周围组织。在一些实施例中，使能量递送元件冷却使得可以在更低的温度下递送比在不冷却的情况下可达到的高的功率电平。该特征预计有助于在治疗期间形成更深和/或更大的病变部，降低内膜表面温度，和/或允许在处理期间更长的激活时间，并且降低过热风险。
下面参照图1-9B来描述本技术的若干实施例的具体细节。虽然许多实施例在下文中结合用于使用多电极阵列进行肾神经的血管内调节的装置、系统和方法来描述，但除了本文所述这些之外的其它应用和其它实施例也在本技术的范围内。另外，本技术的若干其它实施例可具有与本文所述那些不同的构型、部件或程序。因此，本领域的普通技术人员将相应地理解，该技术可具有带有附加元件的其它实施例，或者该技术可具有不具有下文参照图1-9B示出和描述的特征中的一些的其它实施例。
如本文所用，术语“远端”和“近端”限定相对于治疗的临床医生或临床医生的控制装置(例如，手柄组件)的位置或方向。“远端”或“向远端”是远离临床医生或临床医生的控制装置的位置或在远离临床医生或临床医生的控制装置的方向上。“近端”和“向近端”是靠近临床医生或临床医生的控制装置的位置或在朝向临床医生或临床医生的控制装置的方向上。
I.肾神经调节
肾神经调节是使支配肾的神经部分或完全失能或其它方式的有效中断。特别地，肾神经调节包括抑制、减少、和/或阻滞沿着支配肾的神经纤维(即，传出和传入神经纤维)的神经通信。这种失能可以是长期的(例如，永久性的或持续数月、数年或数十年)或短期的(例如，持续数分钟、数小时、数天或数周)。肾神经调节预计可有效治疗若干以综合交感神经活性増加为特征的临床状况，特别是与中枢交感过度刺激相关联的状况，例如，高血压、心力衰竭、急性心肌梗塞、代谢综合症、胰岛素抵抗、糖尿病、左心室肥厚、慢性和终末期肾病、心力衰竭中不适当的流体潴留、心-肾综合症、骨质疏松症、以及猝死。传入神经信号的减少有助于交感神经紧张/交感神经激动的全身降低，并且肾神经调节预计可用于治疗若干与系统性交感神经过度活动或活动亢进相关联的状况。肾神经调节可以潜在的有益于由交感神经支配的各种器官和身体结构。
各种技术可用于使诸如支配肾的那些的神经通路部分地或完全地失能。通过(多个)能量递送元件向组织的能量(例如，电能、热能)的有目的施加可在紧贴或邻近肾动脉的外膜的肾动脉的局部区域和肾丛的相邻区域引起一种或多种所需的热加热效应。热加热效应的有目的施加可沿着肾丛的全部或一部分实现神经调节。
热加热效应可包括热消融和非消融性热变或损伤(例如，通过持续加热和/或电阻加热)。所需的热加热效应可包括将目标神经纤维的温度升高至所需的阈值以上以实现非消融性热变，或更高的温度以上以实现消融性热变。例如，对于非消融性热变来说，目标温度可高于体温(例如，大约37℃)但低于约45℃，或者对于消融性热变来说目标温度可以为约45℃或更高。
更具体而言，通过适度加热目标神经纤维或灌注该目标纤维的血管结构，使其暴露于超过约37℃的体温但低于约45℃的温度的热能(热)可引起热变。在血管结构受影响的情况下，该目标神经纤维拒绝灌注，导致此神经组织的坏死。例如，这可以引起纤维或结构中的非消融性热变。通过大幅度加热纤维或结构，暴露于约45℃以上或约60℃以上的温度的热量可引起热变。例如，这种较高的温度可以热消融目标神经纤维或血管结构。在一些患者中，可能希望实现这样的温度：该温度可热消融目标神经纤维或血管结构，但低于约90℃、或低于约85℃、或低于约80℃、和/或低于约75℃。无论用什么类型的热暴露来引起热神经调节，预计都会减少肾交感神经活性(RSNA)。
II.神经调节系统的所选实施例
图1示出了根据本发明的技术的实施例构造的肾神经调节系统10(“系统10”)。系统10包括能操作地联接到能量源或能量发生器26(例如，RF能量发生器)的血管内导管12。导管12可包括细长轴16，其具有近端部分18、在近端部分18的近端区域的手柄34、以及远端部分20。导管12还可包括在远端部分20处(例如，附接到远端部分20、限定远端部分20的部段等)的治疗组件或处理部段21(示意性地示出)。如下文进一步详细解释的，治疗组件21可包括支撑结构22和两个或更多个能量递送元件24(例如，电极)的阵列，其被构造成以低轮廓构型递送至肾血管(例如，肾动脉)。在递送至肾血管内的目标处理部位时，治疗组件21还被构造成部署至膨胀状态(例如，大体上螺旋/螺旋状的构型)，以用于在处理部位递送能量并且提供对治疗有效的电诱导和/或热诱导的肾神经调节。备选地，部署状态可以是非螺旋的，前提条件是部署状态将能量递送至处理部位。治疗组件21可使用各种合适的机构或技术(例如，自膨胀、经由致动器远程致动等)在递送状态和部署状态之间转变。
治疗组件21的近端由细长轴16的远端部分20承载或固结到远端部分20。治疗组件21的远端可利用例如无创伤顶端40终止导管12。在一些实施例中，治疗组件21的远端也可被构造成接合系统10或导管12的另一元件。例如，治疗组件21的远端可限定用于接纳导丝(未示出)的通路，以使用沿导丝("OTW")或快速交换("RX")技术递送处理装置。下面描述关于这样的布置的另外的细节。
导管12可经由电缆28电联接到能量源26，并且能量源26(例如，RF能量发生器)可被构造成产生所选模态和量值的能量，以用于经由能量递送元件24递送至处理部位。如下文更详细描述的，供给丝(未示出)可沿细长轴16或通过轴16中的管腔延伸至各个能量递送元件24并且将处理能量传输至能量递送元件24。在一些实施例中，每个能量递送元件24包括其自有的供给丝。然而，在其它实施例中，两个或更多个能量递送元件24可电联接到相同的供给丝。诸如脚踏板或手持远程控制装置的控制机构32可连接到能量源26，以允许临床医生发起、终止和可选地调整能量源26的各种操作特性，包括但不限于功率递送。远程控制装置(未示出)可定位在无菌区中并且能操作地联接到能量递送元件24，并且可被构造成允许临床医生选择性地激活和灭活能量递送元件24。在其它实施例中，远程控制装置可嵌入手柄组件34中。
能量源或能量发生器26可被构造成经由自动化控制算法30和/或在临床医生的控制下递送处理能量。例如，能量源26可包括计算装置(例如，个人计算机、服务器计算机、平板计算机等)，其具有处理电路(例如，微处理器)，处理电路被构造成执行与控制算法30有关的存储的指令。此外，处理电路可被构造成执行一个或多个评价/反馈算法31，该算法可被通信至临床医生。例如，能量源26可包括监视器或显示器33和/或相关联的特征，其可被构造成提供功率电平、传感器数据和/或其它反馈的可视指示、可听指示或其它指示。能量源26也可被构造成将反馈和其它信息通信至另一装置，例如，导管室中的监视器。
能量递送元件24可被构造成同时地、选择性地或顺序地独立递送功率(即，可以以单极方式使用)，和/或可以在元件的任何所需组合之间递送功率(即，可以以双极方式使用)。在单极实施例中，中性或弥散电极38可电连接到能量发生器26并且附接到患者的外部(例如，如图2所示)。此外，临床医生任选地可选择将哪个能量递送元件24用于功率递送，以便在肾动脉内形成具有各种形状或图案的高度定制的(多个)病变部。在另一些实施例中，系统10可被构造成递送其它合适形式的处理能量，例如，单极和双极电场的组合。
在若干实施例中，能量源26可包括射频识别(RFID)评价模块(未示出)，其安装在能量源26上的一个或多个端口处或附近并且被构造成无线地读取和写入到导管12上的一个或多个RFID标签(未示出)。在一个特定实施例中，例如，导管12可包括容纳在联接到能量源26的电缆28的连接器部分内或以其它方式附接到该连接器部分的RFID标签。RFID标签可包括例如天线和用于处理信号、发送/接收RF信号和在存储器中存储数据的RFID芯片。合适的RFID标签包括例如可得自日本东京的Fujitsu Limited的MB89R118RFID标签。RFID标签的存储器部分可包括分配给不同类型数据的多个块。例如，第一存储块可包括验证标识符(例如，与具体类型的导管相关联且使用加密算法由RFID标签的唯一ID生成的唯一标识符)，并且第二存储块可被分配为导管使用计数器，其可在导管使用之后通过由能量源26承载的RFID模块读取并且然后写入。在其它实施例中，RFID标签可包括分配用于附加的导管使用计数器的附加的存储块(例如，以允许导管12使用具体的有限次数)和/或与导管12相关联的其它信息(例如，批号、客户编号、导管型号、汇总数据等)。
由能量源26承载的RFID评价模块可包括天线和处理电路，该天线和处理电路一起用来与能量源26的一个或多个部分通信，并且无线地读写到在其附近的一个或多个RFID标签(例如，当包括RFID标签的电缆28附接到能量源26时)。合适的RFID评价模块包括例如可得自德克萨斯州达拉斯的Texas Instruments Incorporated的TRF7960A评价模块。
在操作中，RFID评价模块被构造成从RFID标签(其由电缆28或导管12的另一合适部分承载)读取信息，并且将该信息通信至能量源26的软件以验证附接的导管12(例如，验证导管12与能量源26兼容)、读取与特定导管12相关联的此前使用次数、和/或写入到RFID标签以指示导管使用。在各种实施例中，能量源26可被构造成当RFID标签的预定条件不满足时禁用到导管12的能量递送。例如，当每个导管12连接到能量源26时，RFID评价模块可从RFID标签读取加密格式的唯一的防伪号码，将该号码解密，然后认证该号码和用于识别的导管(例如，与特定能量源26兼容的导管、非伪造导管等)的导管数据格式。在各种实施例中，RFID标签可包括对应于具体类型的导管的(多个)标识符，并且RFID评价模块可将该信息发送至能量源26的主控制器，该控制器可将能量源26的设置(例如，控制算法30)调整至与具体导管相关联的所需的操作参数/特性(例如，功率电平、显示模式等)。此外，如果RFID评价模块将导管12识别为伪造的或者说是不能识别导管12，那么能量源26可以自动地禁用导管12的使用(例如，阻止能量递送)。
一旦导管12被识别，RFID评价模块就可读取RFID标签存储器地址空间以确定导管12是否已此前连接到发生器(即，此前使用的)。在某些实施例中，RFID标签可将导管12限制为单次使用，但在其它实施例中，RFID标签可被构造成提供用于不止一次的使用(例如，2次使用、5次使用、10次使用等)。如果RFID评价模块识别导管12已被写入(即，使用)超过预定使用极限，那么RFID模块可与能量源26通信以禁用到导管12的能量递送。在某些实施例中，RFID评价模块可被构造成在预定时间段(例如，5小时、10小时、24小时、30小时等)内到能量源的所有导管连接解释为单个连接(即，单次使用)，并且允许导管12在该预定时间段内使用多次。在导管12已被检测、识别和判断为“新连接”(例如，未使用超过预定极限)之后，RFID评价模块可写入到RFID标签(例如，系统使用时间和日期和/或其它信息)以表明导管12已被使用。在其它实施例中，RFID评价模块和/或RFID标签可具有不同的特征和/或不同的构型。
系统10也可包括位于能量递送元件24附近或内部的一个或多个传感器(未示出)。例如，系统10可包括温度传感器(例如，热电偶、热敏电阻器等)、阻抗传感器、压力传感器、光学传感器、流量传感器、和/或连接到一个或多个供给丝(未示出)的其它合适的传感器，该供给丝发送来自传感器的信号和/或将能量传输至能量递送元件24。图2(附加地参照图1)示出了利用系统10的一个实施例调节肾神经。导管12提供通过血管内路径P到肾丛RP的通路，例如，在股动脉(图示)、肱动脉、桡动脉或腋动脉中的经皮进入部位到相应的肾动脉RA内的目标向处理部位。如图所示，轴16的近端部分18的部段暴露在患者体外。通过从血管内路径P外部操纵轴16的近端部分18，临床医生可将轴16推进通过有时曲折的血管内路径P并且远程操纵轴16的远端部分20。在图2所示实施例中，在OTW技术中利用导丝66将治疗组件21在血管内递送至处理部位。如此前所提及的，治疗组件21的远端可限定用于接纳导丝66的管腔或通路，以使用OTW或RX技术递送导管12。在处理部位处，导丝66可被至少部分地轴向撤出或移除，并且治疗组件21可转变或以其它方式被移动至部署布置以用于在处理部位处递送能量。关于这样的布置的另外的细节在下文中参照图3A和图3B进行描述。导丝66可包括尺寸设计成能滑动地配合在管腔内的任何合适的医用导丝。在一个特定实施例中，例如，导丝66可具有0.356mm(0.014英寸)的直径。在其它实施例中，治疗组件21可在导向鞘(未示出)内使用或不使用导丝66递送至处理部位。当治疗组件21处于目标部位时，导向鞘可被至少部分地撤出或回缩，并且治疗组件21可被转变成部署布置。关于这种类型的构型的另外的细节在下文中描述。在另一些实施例中，轴16可以是自身能转向的，使得治疗组件21可以在没有导丝66和/或导向鞘帮助的情况下递送至处理部位。
图像引导(例如，计算机断层扫描(CT)、荧光镜透视检查、血管内超声波(IVUS)、光学相干断层扫描(OCT)、心内回波心动描记法(ICE)、或另一种合适的引导方式、或它们的组合)可用来辅助临床医生定位和操纵治疗组件21。例如，荧光镜透视检查系统(例如，包括平板探测器、X射线或C形臂)可被旋转以准确地可视化和识别目标处理部位。在其它实施例中，处理部位可使用IVUS、OCT和/或其它合适的图像标测方式确定，该图像标测方式在递送导管12之前将目标处理部位与能识别的解剖结构(例如，脊柱特征)和/或射线不可透的标尺(例如，定位在患者下方或身上的)关联。此外，在一些实施例中，图像引导部件(例如，IVUS、OCT)可与导管12集成和/或并行于导管12运行以在治疗组件21的定位期间提供图像引导。例如，图像引导部件(例如，IVUS或OCT)可联接到治疗组件21中的至少一个(例如，靠近治疗臂25)以提供靠近目标部位的脉管系统的三维图像，以便有利于将多电极组件定位或部署在目标肾血管内。
来自能量递送元件24的能量的有目的施加可接着被施加到目标组织以在肾动脉的局部区域和肾丛RP的相邻区域引发一个或多个所需的神经调节效应，所述区域紧贴在肾动脉RA的外膜内、邻近外膜或紧邻外膜。能量的有目的施加可沿着肾丛RP的全部或至少一部分实现神经调节。神经调节效应通常至少部分地是功率、时间、在能量递送元件24(图1)和血管壁之间的接触、以及通过血管的血流的函数。神经调节效应可包括神经切除、热消融、和/或非消融性热变或损伤(例如，通过持续加热和/或电阻加热)。所需的热加热效应可包括将目标神经纤维的温度升高至所需的阈值以上以实现非消融性热变，或更高的温度以上以实现消融性热变。例如，对于非消融性热变来说，目标温度可高于体温(例如，大约37℃)但低于约45℃，或者对于消融性热变来说目标温度可以为约45℃或更高。所需的非热性神经调节效应可包括改变在神经中传输的电信号。
图3A是在患者体外处于递送状态(例如，低轮廓或收缩构型)的导管12的远端部分20和治疗组件或处理部段21的侧视图，并且图3B是在患者体外处于部署状态(例如，膨胀构型)的治疗组件21的透视图。如前所述，导管12可被构造用于从进入部位的OTW递送，其中，导丝66(图2)被初始地插入处理部位(例如，在肾动脉内)，并且导管12被安装在导丝上。如下文更详细描述的，导丝可被或者插入远端部分20中或者至少部分地从远端部分20撤出以将治疗组件21在递送状态(图3A)和部署状态(图3B)之间转变。例如，如图3A所示，延伸通过导管12的长度的至少一部分的导丝(未示出)可被构造成在递送期间拉直导管12的预成型的螺旋/螺旋状控制构件50(以虚线示意性地示出)，并且导丝可被至少部分地撤出或相对于远端部分20能滑动地移动，以允许治疗组件21转变到部署状态(图3B)。
如图3A中最清楚地看到的，治疗组件21包括由支撑结构22承载的多个(例如，四个、五个等)能量递送元件24。在该实施例中，支撑结构22包括柔性管42和在管42内的预成型的控制构件50。柔性管42可由聚合物材料构成，例如，聚酰胺、聚酰亚胺、在商标PEBAX下销售的聚醚-酰胺嵌段共聚物、聚对苯二甲酸乙二醇酯(PET)、聚丙烯、在商标CARBOTHANE下销售的脂族聚碳酸酯基热塑性聚氨酯、或提供所需柔韧性的聚醚醚酮(PEEK)聚合物。然而，在其它实施例中，管42可由其它合适的材料构成。
如上文所提及的，预成型的控制构件50可用来向导管12的相对柔性的远端部分20提供螺旋/螺旋状形状。如图3B中最清楚地看到的，例如，控制构件50为管状结构，该结构包括具有穿过其中的管腔的镍钛诺多股绞丝，其在商标HELICAL HOLLOW STRAND(HHS)下销售并且可从印第安那州韦恩堡的Fort Wayne Metals商购获得。管状控制构件50可由多种不同类型的材料形成，可布置成单层或双层构型，并且可以制造成所选的张力、压缩、扭矩和节距方向。例如，HHS材料可使用激光、电火花加工(EDM)、电化学磨削(ECG)、或其它合适的手段切割，以获得所需的最终部件长度和几何形状。例如，如图3B中最清楚地看到的，本实施例中的控制构件50具有预设的螺旋/螺旋状构型，其限定治疗组件21的部署状态，使得治疗组件21的能量递送元件24彼此偏移(例如，相对于肾动脉的纵向轴线角向地和纵向地偏移)，并且可以定位成与肾动脉的壁稳定地并置(图2)以用于处理。出于分类目的，处于其部署状态的治疗组件21的预设螺旋形状可由尺寸(例如，螺旋直径和节距)限定，该尺寸不同于HHS自身的尺寸(例如，螺旋直径和节距)。换句话讲，形成控制构件50的多股中空管自身被预设成螺旋形状。
由(多个)镍钛诺多股绞丝或其它类似的材料形成控制构件50预计会消除对支撑结构22内的任何附加的(多个)加强丝或结构的需求，所述加强丝或结构用于为治疗组件21提供所需水平的支撑和刚度。该特征预计会减少形成导管12所需的制造过程的数目并且减少装置所需材料的数目。治疗组件21的另一个特征在于，控制构件50和管42的内壁紧密接触，并且在控制构件50和管42之间存在很少的空间或不存在空间(如图4中最清楚地看到的)。在一个实施例中，例如，管42可在组装之前膨胀，使得在制造过程期间将热空气施加到管42可将管收缩到控制构件50上，如熟悉收缩管材料的普通使用的技术人员应理解的那样。该特征预计会抑制或消除当治疗组件21从相对平直的递送状态转变至部署的大体上螺旋状的状态时在管42中可能发生的褶皱或扭结。
在其它实施例中，控制构件50和/或支撑结构22的其它部件可由不同的材料构成和/或具有不同的布置。例如，控制构件50可由其它合适的形状记忆材料(例如，镍钛合金(镍钛诺)、除HHS之外的丝或管、形状记忆聚合物、电活性聚合物)形成，该材料被预成形或预成型为所需的部署状态。备选地，控制构件50可由多种材料形成，例如，一种或多种聚合物和金属的复合材料。
能量递送元件24的阵列可包括一系列单独的带状电极，其沿支撑结构22间隔开且使用粘合剂结合到管42。带状或管状电极可在一些实施例中使用，例如，因为它们相比盘状或平坦电极通常具有用于消融的较低的功率要求。然而，在其它实施例中，盘状或平坦电极也是合适的。在另一个实施例中，可以使用具有螺旋或线圈形状的电极。在一些实施例中，能量递送元件24可以沿着支撑结构22的长度等间距地间隔开。能量递送元件24可由任何合适的金属材料(例如，金、铂、铂和铱的合金等)形成。然而，在其它实施例中，能量递送元件24的数目、布置和/或组成可以变化。
图4是图3A的导管12的一部分的放大视图。一起参看图1和图4，每个能量递送元件或电极24由延伸通过管42的管腔的导体或双股丝44电连接到能量源26(图1)。每个能量递送元件24可被焊接或以其它方式电联接到其能量供给丝44，并且每个丝44可延伸通过管42和细长轴16(图1)达轴的整个长度，使得其近端联接到能量源26(图1)。如上所述，管42被构造成紧密地抵靠控制构件50和丝44配合，以使在管42的内部部分和定位在其中的部件之间的空间最小化，以有助于防止在部署期间在治疗组件21中形成褶皱。在一些实施例中，导管12也可包括在控制构件50上的绝缘层(例如，PET或另一种合适的材料的层)，以将控制构件50的材料(例如，HHS)与丝44进一步电隔离。
如图4中最清楚地看到的，每个能量递送元件24可包括渐缩的端部24a(例如，圆角)，其被构造成在管42的外表面和对应的能量递送元件24的外表面之间提供钝角。由渐缩的端部24a提供的角度上的平滑过渡预计有助于在导向鞘或加载工具在推进和回缩期间在治疗组件21(图3A和图3B)上移动时防止导向鞘或加载工具变得卡住或捕捉能量递送元件24的边缘。在其它实施例中，能量递送元件24上的渐缩部分24a的范围可以变化。在一些实施例中，渐缩的端部24a包括在对应的能量递送元件24的任一端处由粘合剂材料形成的圆角。然而，在其它实施例中，渐缩的端部24a可由与管42相同的材料形成(例如，与管42一体地形成或单独地形成并且附接到对应的能量递送元件24的任一端)。此外，渐缩部分24a是在一些实施例中可能不包括的可选特征。
重新参看图3A和图3B，治疗组件21包括在组件21的远端处的无创伤的柔性弯曲顶端40。弯曲顶端40被构造成提供用于导丝66(图2)的远端开口41，其在治疗组件21处于预设的部署构型时将导丝导向远离肾动脉的壁。该特征预计有利于螺旋状治疗组件21在其膨胀时在肾血管中的对齐，同时也降低了当导丝远端顶端从开口41被推进时损伤血管壁的风险。顶端40的曲率可根据治疗组件21的特定尺寸/构型而变化。如图3B中最清楚地看到的，例如，在图示实施例中，顶端40为弯曲的，使得其偏离由控制构件50限定的预设的螺旋/螺旋状轴线。然而，在其它实施例中，顶端40可具有不同的曲率。在一些实施例中，顶端40也可包括一个或多个射线不可透标记物52和/或一个或多个传感器(未示出)。顶端40可通过粘合剂、压接、包覆成型或其它合适的技术固结到支撑结构22的远端。
柔性弯曲顶端40可由聚合物材料(例如，在商标PEBAX下销售的聚醚-酰胺嵌段共聚物)、热塑性聚醚型聚氨酯材料(在商标ELASTHANE或PELLETHANE下销售)、或具有所需性质(包括所选硬度)的其它合适材料制成。如上所述，顶端40被构造成提供用于导丝66的开口，并且希望顶端自身在操作期间保持所需的形状/构型。因此，在一些实施例中，一种或多种附加材料可添加到顶端材料以帮助改善顶端形状保持。在一个特定实施例中，例如，约5至30重量％的硅氧烷可与顶端材料(例如，热塑性聚醚型聚氨酯材料)共混，并且电子束或γ照射可用来引发材料的交联。在其它实施例中，顶端40可由(多种)不同的材料形成和/或具有不同的布置。
在操作中(并且参照图2、图3A和图3B)，在将治疗组件21定位在患者的肾动脉RA内的所需位置处之后，治疗组件21可从其递送状态转变至其部署状态或部署布置。这种转变可使用如本文结合特定实施例描述的装置部件的布置以及它们的各种部署模式来引发。在一个实施例中，例如，可通过使导丝66回缩直到导丝66的远端顶端与导管12的顶端40大体上对齐来部署治疗组件21为止。在一些实施例中，导丝66可具有沿其长度变化的刚度或柔韧性，以便向远端提供增加的柔韧性。当柔韧性变化的导丝66如上所述部分地回缩时，控制构件50的预设的螺旋形状提供形状恢复力，该恢复力足以克服由导丝66的最远端部分提供的拉直力，使得治疗组件21可部署成其螺旋构型。此外，由于导丝66的柔性远端部分在部署状态下保持在治疗组件21内，导丝66可在处理期间赋予螺旋形部分额外的结构完整性。该特征预计有助于缓解或减少与在处理期间将治疗组件21保持在位相关联的问题(例如，有助于血管收缩)。
在另一个实施例中，导丝66可具有这样的刚度分布：其允许导丝66的远端部分保持从开口41延伸，同时仍允许治疗组件21转变到其部署构型。在另一些实施例中，导丝66可从治疗组件21完全撤出(例如，导丝66的最远端部分在治疗组件21近侧)以允许转变，同时导丝66的最远端部分保持在轴16内。在又一个实施例中，导丝66可从轴16完全撤出。在上述示例中的任一个中，临床医生可充分地撤出导丝66以观察治疗组件21向部署构型的转变和/或直到X射线图像显示导丝66的远端顶端相对于治疗组件21处于所需位置(例如，与顶端40大体上对齐、从治疗组件21完全撤出等)为止。在一些实施例中，导丝66撤出的程度可至少部分地基于临床医生关于所选的导丝和实现部署所需的撤出的程度的判断。
在处理之后，治疗组件21可通过使导丝66相对于治疗组件21轴向推进而转变回低轮廓递送构型。在一个实施例中，例如，导丝66可被推进直到导丝66的远端顶端与顶端40大体上对齐为止，然后可将导管12在静止的导丝66上拉回。然而，在其它实施例中，导丝66的最远端部分可相对于治疗组件21被推进至不同的位置，以实现治疗组件21返回低轮廓布置的转变。
以上所述导管系统的实施例包括手术导丝，用于将导管引导至处理部位并且也将治疗组件或处理部段约束在低轮廓递送状态。在另外的实施例中，根据本发明的技术构造的导管系统还可包括外部加载工具，其可在治疗组件上设置和回缩以进一步帮助治疗组件在递送构型和部署构型之间转变。
例如，图5是根据本发明的技术的实施例的加载工具190的局部示意性侧视图。加载工具190是管状结构，其被构造成能沿轴16和治疗组件21的外表面滑动地移动(为了说明目的，治疗组件21和相关联的特征以虚线示出)。加载工具190具有适合将治疗组件21保持在低轮廓构型的尺寸和刚度，以便将导丝66(图2)向后加载，即，将导丝66的近端插入远端开口41中。在图示实施例中，加载工具190可包括渐缩部分192，以有助于方便鞘管在治疗组件21和相关联的能量递送元件24上的推进。在一些实施例中，加载工具190的远端部分194也可包括平滑倒圆的内部和外部边缘195，以在加载工具相对于治疗组件21的推进期间有助于缓和在能量递送元件24上的加载工具的内壁。加载工具190可由高密度聚乙烯(HDPE)或具有所需强度和润滑性的其它合适材料构成。在另一些实施例中，加载工具190可由两种或更多种不同的材料构成。在一个实施例中，例如，渐缩部分192远端的加载工具190的较大直径部段可由HDPE构成，而在渐缩部分192近端的加载工具190的较小直径部段可由线性低密度聚乙烯(LLDPE)构成。在另一些实施例中，加载工具190可由不同的材料构成和/或具有不同的布置。
在一些实施例中，在导管12在处理之前在患者体外的同时，加载工具190可结合导管12使用，然后在导管12插入患者体内之前从导管12移除。更具体而言，如上文所讨论的，在导丝被向后加载(从导管12的远端朝近端移动)的同时，加载工具190可用来将治疗组件21保持在低轮廓构型。加载工具190可接着被从导管12移除，并且治疗组件21可在导丝的支撑下约束在递送构型。在另一个实施例中，在导丝的向后加载之后，加载工具190可保持安装在导管12上，但可以沿导管12的长度一直滑动至手柄34(图1)附近的导管12的近端部分18。这样，加载工具190与导管12保持在一起，但在处理期间不碍事。
然而，在另一些实施例中，加载工具190可在处理期间保持在导管12的远端部分20(图1)处或附近。例如，在一个实施例中，临床医生可将加载工具190保持在导管12的远端部分20处或附近，然后将加载工具190插入连接到引导导管(未示出)的止血阀(未示出)内。根据加载工具190的轮廓和止血阀的内径，临床医生也许能将加载工具190的大约2至4cm插入止血阀中。该方法的一个优点是，当导管12被推进通过止血阀时，治疗组件21(图3A和图3B)被进一步保护，并且临床医生预计感受到导管12和止血阀之间的减小摩擦或感受不到摩擦。然而，在其它实施例中，加载工具190在操作期间可具有相对于止血阀和/或系统10的其它部件(图1)的不同布置。
III.相干解剖学和生理学
以下讨论提供关于相关患者解剖学和生理学的更多细节。本节意图补充并详细叙述关于相关解剖学和生理学的前述讨论，并提供关于所公开的技术的附加背景和与肾神经调节相关联的治疗益处。例如，如前所述，肾脉管系统的多个性质可以提供用于实现肾神经调节的处理装置和关联方法的设计的信息，并且对此类装置施加具体的设计要求。具体的设计要求可包括进入肾动脉、输尿管或肾盂解剖结构、有利于处理装置的治疗元件与腔表面或壁之间的稳定接触和/或使用治疗元件来有效地调节肾神经。
A.交感神经系统
SNS是自主神经系统以及肠神经系统和副交感神经系统的分支。其在基础水平始终是活动的(称为交感紧张)且在紧张时间期间变得更加活动。就像神经系统的其它部分，交感神经系统通过一系列互连的神经元进行操作。交感神经元常常被视为周围神经系统(PNS)的一部分，但许多在中枢神经系统(CNS)内。脊髄的交感神经元(其为CNS的一部分)经由一系列的交感神经节与周围交感神经元通信。在神经节内，脊髓交感神经元通过突触接合周围交感神经元。因此，将脊髓交感神经元称为突触前(或节前)神经元，同时将周围交感神经元称为突触后(或节后)神经元。
在交感神经节内的突触处，节前交感神经元释放乙酰胆碱，其为结合并激活节后神经元上的尼古丁乙酰胆碱受体的化学信使。响应于这种刺激，节后神经元主要释放降肾上腺素(去甲肾上腺素)。延长的激活可引起肾上腺素从肾上腺髓质的释放。
一旦被释放，去甲肾上腺素和肾上腺激素将肾上腺素能受体结合在周围组织上。结合到肾上腺素能受体引起神经元和荷尔蒙反应。生理表现包括瞳孔放大、心律増加、偶发性呕吐和血压升高。由于汗腺的胆碱能受体的结合，还看到出汗増加。
交感神经系统负责对活体中的许多体内平衡机制进行向上和向下调节。来自SNS的纤维延伸通过几乎每个器官系统中的组织，向如瞳孔直径、肠道动力和尿排出量一祥多种多样的特性提供至少某些调节功能。此反应也称为身体的交感-肾上腺反应，因为终止于肾上腺髓质中的节前交感神经纤维(而且还有所有其它交感神经纤维)分泌乙酰胆碱，这激活肾上腺素(肾上腺激素)的分泌并在较少的程度上分泌降肾上腺素(去甲基肾上腺素)。因此，直接地经由通过交感神经系统传输的脉冲且间接地经由从肾上腺髓质分泌的儿茶酚胺来介导主要作用在心血管系统上的此反应。
科学研究通常将SNS视为自动调节系统，即，在没有有意识思想的介入的情况下操作的系统。某些进化论理论家提出交感神经系统在早期生物体中操作以保持幸存，因为交感神经系统负责使人体预先顺备好动作。此预先准备的一个示例发生在睡醒之前的时刻，其中交感神经流出物本能地増加以准备进行动作。
1.交感神经链
如图6所示，SNS提供允许大脑与身体通信的神经网络。交感神经源自于脊柱内部，朝向中间外侧细胞柱(或侧角)中的脊髓的中部，在脊髄的第一胸节处开始，并且被认为延伸至第二或第三腰椎节段。由于其细胞在脊髄的胸部和腰部区域中开始，所以将SNS说成是具有胸腰流出物。这些神经的轴突通过前根/根离开脊髄。其在脊(感觉)神经节附近通过，在那里其进入脊神经的前支。然而，不同于躯体神经支配，其快速地通过连接到脊柱旁(其在脊柱附近)或在脊柱旁边延伸的脊柱前(其在主动脉分叉点附近)神经节的白支连接物分离出来。
为了到达目标器官和腺体，轴突应在体内行进很长的距离，并且为了做到这一点，许多轴突通过突触传输将其消息中继至第二细胞。轴突的末端跨越空间(突触)连结到第二细胞的树突。第一细胞(突触前细胞)跨越突触间隙发送神经递质，在那里其激活第二细胞(突触后细胞)。消息然后被载送到最终目的地。
在SNS和周围神经系统的其它组成部分中，在称为神经节的部位处产生这些突触。发送其纤维的细胞称为神经节前细胞，而其纤维离开神经节的细胞称为神经节后细胞。如前所述，SNS的神经节前细胞位于脊髓的第一胸节(T1)和第三腰节(L3)之间。神经节后细胞的细胞体在神经节内，并发送其轴突到目标器官或腺体。
神经节不仅包括交感干，还包括颈神经节(上、中和下)，其发送交感神经纤维到头和胸腔器官，以及腹腔和肠系膜神经节(发送交感纤维到肠道)。
2.肾的神经
如图7所示，肾神经系统包括肾丛，其与肾动脉紧密关联。肾丛是围绕肾动脉的自主神经丛，并且埋入肾动脉的外膜内。肾丛沿肾动脉延伸直至其到达肾髓质。作用于肾丛的纤维产生于腹腔神经节、肠系膜上神经节、主动脉肾神经节和主动脉丛。肾丛也称为肾神经，主要由交感成分构成。没有(或至少很少)肾的副交感神经活动。
神经节前神经细胞体位于脊髓的中间外侧细胞柱中。神经节前轴突通过脊柱旁神经节(它们不形成突触)成为内脏小神经、内脏最小神经、第一腰内脏神经、第二腰内脏神经，并且延伸到腹腔神经节、肠系膜上神经节和主动脉肾神经节。神经节后神经细胞体离开腹腔神经节、肠系膜上神经节和主动脉肾神经节，到达肾丛并分布于肾脉管系统中。
3.肾交感神经活动
消息以双向流动的方式通过SNS。传出消息可同时触发身体不同部分的改变。例如，交感神经系统可使心律加速、使支气管通道变宽、降低大肠的活动(运动)、收缩血管、增加食道内蠕动、引起瞳孔放大、竖毛(鸡皮疙瘩)和排汗(发汗)以及使血压升高。传入消息将来自体内各个器官和感觉受体的信号载送至其它器官(尤其是脑)。
高血压、心力衰竭和慢性肾病是由SNS特别是肾交感神经系统的慢性激活造成的许多疾病状态中的一些。SNS的慢性激活是造成这些疾病状态进展的适应不良反应。肾素-血管紧张素-醛固酮系统(RAAS)的药学管理是降低SNS过量活性的长期存在但一定程度上无效的方法。
如上文所提及的，肾交感神经系统已经确定为实验和人体中高血压、容量超负荷状态(例如心力衰竭)和进展性肾病的复杂发病机制的主要作用因子。采用放射性示踪剂稀释法来测量去甲肾上腺素从肾溢入血浆的研究显示，与心脏中NE溢出增加一致，原发性高血压患者，特别是年轻高血压受试者中肾去甲肾上腺素(NE)溢出速率增加，这与早期高血压中通常见到的血液动力学特征一致，并且表征为增加的心律、心输出量和肾血管抗性。现在已知原发性高血压通常为神经源性，经常伴有显著的交感神经系统过度活动。
心肾交感神经活性的激活甚至在心力衰竭中更加显著，如此患者组中从心和肾到血浆的超常NE溢出增加所证明的。与该意见相符的是，近期显示充血性心力衰竭患者中肾交感神经激活对全因死亡和心脏移植的强阴性预测值，该值独立于整体交感活性、肾小球滤过率和左心室射血分数。这些发现支持设计成降低肾交感刺激的治疗方案有提高心力衰竭患者中存活率的潜能的观念。
慢性和终末期肾病的特征是升高的交感神经活性。在终末期肾病患者中，高于中值的去甲肾上腺素血浆水平已经显示能预测全因死亡和心血管疾病死亡。这对患有糖尿病肾病或造影剂肾病的患者来说同样如此。有强有力的证据显示，源自患病肾的感觉传入信号是起始和维持该患者组内提高的中枢交感流出的主要原因；这促进了慢性交感过度活动的熟知的不良后果的发生，例如高血压、左心室肥大、室性心律失常、心脏性猝死、胰岛素抵抗、糖尿病和代谢综合症。
i.肾交感传出活性
到肾的交感神经终止于血管、肾小球旁器和肾小管中。肾交感神经的刺激可造成肾素释放增加，钠(Na+)重吸收增加和肾血流减少。肾功能的这些神经调节组成部分在表征为交感紧张升高的疾病状态中受到显著刺激，并且明显有助于高血压患者血压升高。作为肾交感传出刺激的结果，肾血流和肾小球滤过率的降低似乎是心肾综合征(其为作为慢性心力衰竭的进展性并发症的肾功能障碍)中肾功能丧失的基础，其具有通常随患者的临床状况和治疗波动的临床病程。阻止肾传出交感刺激结果的药理学策略包括中枢作用的交感神经阻滞药、β-阻滞剂(旨在减少肾素释放)、血管紧张素转换酶抑制剂和受体阻滞剂(旨在阻滞肾素释放后的血管紧张素II作用和醛固酮激活)、以及利尿剂(旨在抵消肾交感介导的水钠潴留)。然而，现有的药理学策略有很大局限性，包括药效有限、依从性问题、副作用及其它。
ii.肾感觉传入神经活性
肾通过肾感觉传入神经与中枢神经系统中的整体结构通信。“肾损伤”的几种形式可以诱导感觉传入信号的激活。例如，肾缺血、搏出量或肾血流下降、或丰富的腺苷可以触发传入神经通信的激活。如图8A和图8B所示，这种传入通信可以从肾到脑或可以从一个肾到另一个肾(通过中枢神经系统)。这些传入信号是中枢整合的，并且可导致交感溢出增加。这种交感神经激动针对肾，因此激活RAAS并引起增加的肾素分泌、钠潴留、流体容积保持和血管收缩。中枢交感过度活动也影响具有交感神经的其他器官和身体结构，例如心脏和外周脉管系统，导致所述交感激活的不良作用，其在一些方面也引起血压升高。
因此，生理学显示(i)传出交感神经对组织的调节会减少不合适的肾素释放、钠潴留和肾血流减少，并且(ii)传入交感神经对组织的调节会通过其对下丘脑后部和对侧肾的直接影响来减少对高血压和与增加的中枢交感紧张相关的其它疾病状态的全身作用。除了传入肾神经调节的中枢低血压效果外，预期到诸如心脏和脉管系统的各种其它器官的中枢交感流出也有所希望的减少。
B.肾神经调节的其它临床益处
如前所述，肾神经调节似乎在治疗以增加的整体和特别是肾交感活动为特征的若干临床病症中有价值，例如，高血压、代谢综合症、胰岛素抵抗、糖尿病、左心室肥大、慢性终末期肾病、心力衰竭中的不宜的流体潴留、心-肾综合症和猝死。由于传入神经信号的减少造成交感紧张/交感神经激动的全身降低，肾神经调节也可用于治疗与全身交感神经过度活动相关的其它病症。因此，肾神经调节也对包括图6确定的那些的具有交感神经的其它器官和身体结构有利。
C.实现到肾动脉的血管内通路
根据本发明的技术，与左和/或右肾动脉紧密相关的左和/或右肾丛RP的神经调节可通过血管内通路而实现。如图9A所示，由心脏收缩所致的血液流动通过主动脉从心脏左心室输出。主动脉穿过胸部下行，并分枝进入左肾动脉和右肾动脉。在肾动脉下方，主动脉在左髂动脉和右髂动脉处分枝。左髂动脉和右髂动脉分别下行穿过左腿和右腿，并且加入左股动脉和右股动脉。
如图9B所示，血液在静脉中聚集，并且通过股静脉进入髂静脉且进入下腔静脉，然后回到心脏。下腔静脉分枝进入左肾静脉和右肾静脉。在肾静脉上方，下腔静脉上行以将血液送入心脏的右心房。来自右心房的血液经右心室泵入肺，并在那里充氧。充氧血液从肺送入左心房。来自左心房的充氧血液由左心室送回至主动脉。
如本文所提供的，可在腹股沟韧带中点正下方的股三角底部接入股动脉并插管。导管可通过该通路部位经皮插入股动脉内，穿过髂动脉和主动脉，并置入左肾动脉或右肾动脉。这包括血管内路径，该路径提供到相应的肾动脉和/或其它肾血管的微创通路。
腕部、上臂和肩部区域提供了用于将导管引入动脉系统的其它位置。例如，可在选择情况下使用桡动脉、肱动脉或腋动脉的插管术。利用标准血管造影技术，可使经由这些接入点引入的导管通过左侧的锁骨下动脉(或通过右侧的锁骨下动脉和头臂动脉)，通过主动脉弓，下到降主动脉并进入肾动脉。
D.肾脉管系统的性质和特点
由于根据本发明的技术可通过血管内通路实现左和/或右肾丛的神经调节，肾脉管系统的性质和特点可施加约束于和/或提示用于实现这种肾神经调节的设备、系统和方法的设计。这些性质和特点中的一些可能随不同患者群和/或特定患者的不同时间而不同，对疾病状态做出的反应也可能不同，所述疾病状态为例如高血压、慢性肾病、脉管疾病、终末期肾病、胰岛素抵抗、糖尿病、代谢综合症等。本文中所解释的这些性质和特点可能与方法的功效和血管内装置的具体设计有关。感兴趣的性质可包括，例如，材料/机械、空间、流体动力学/血液动力学、和/或热力学性质。
如上文所述，可将导管通过微创血管内路径经皮推进到左或右肾动脉中。然而，微创肾动脉通路可能会具有挑战性，这是因为，例如，与常规使用导管进入的其它一些动脉相比，肾动脉通常是极其曲折的，可能具有相对较小的直径，和/或可能具有相对较短的长度。此外，肾动脉硬化症常见于多数患者，尤其是那些有心血管疾病的患者。肾动脉解剖结构也可能在患者与患者间有显著差异，其使得微创接入进一步复杂化。在例如相对曲折度、直径、长度和/或动脉粥样硬化斑块负荷、以及肾动脉从主动脉分枝的离源角中都可看到显著的患者差异。用于通过血管内通路来实现肾神经调节的设备、系统和方法在微创地接入肾动脉时，应考虑肾动脉解剖结构的这些方面和其它方面及其在患者群之间的差异。
除复杂的肾动脉通路之外，肾解剖结构的特点也使神经调节设备与肾动脉的腔表面或壁之间的稳定接触的建立复杂化。当神经调节设备包括诸如电极的能量递送元件时，一致定位以及由能量递送元件向血管壁施加的合适的接触力对可预测性而言是重要的。然而，肾动脉内狭窄的空间和该动脉的曲折性通常阻碍了导航。此外，患者的移动、呼吸和/或心动周期可使建立连续接触复杂化。这些因素例如可能引起肾动脉相对于主动脉的显著移动，并且心动周期会使肾动脉短暂扩张(即，引起该动脉的壁搏动)。
在接入肾动脉并促使神经调节设备与该动脉的腔表面之间稳定接触后，可通过神经调节设备安全地调节该动脉的外膜内部和周围的神经。考虑到与这些处理相关的潜在临床并发症，从肾动脉内部实施有效的热处理并非微不足道。例如，肾动脉的内膜和中膜对热伤害是高度脆弱的。如下文更详细讨论的，从动脉外膜分离血管腔的内膜-中膜的厚度意味着目标肾神经可距离该动脉的腔表面数毫米。可向目标肾神经递送充足能量来调节该目标肾神经，而不使血管壁过度冷却或过度受热，以致于使血管壁冻结、脱水或以其它方式受潜在的影响到不期望的程度。与过度受热相关的潜在的临床并发症是由流经该动脉的凝固血液导致的血栓形成。因此，在处理过程中存在于肾动脉中的，尤其是在处理部位可能影响传热动力学的那些复杂流体力学和热力学条件，对于肾动脉内施加能量而言可能是重要的。
由于处理的位置也会影响临床功效，神经调节设备可被构造成允许能量递送元件在肾动脉内能调节的定位和重新定位。例如，考虑到肾神经可能环绕肾动脉周向分布，在肾动脉内应用全周处理可能具有吸引力。在一些情况下，可能由持续的周向处理所致的全周损伤可能潜在地与肾动脉狭窄有关。因此，沿肾动脉纵向上的更多复杂损伤的形成和/或神经调节设备到多个处理位置的重新定位可能是有利的。然而，应当指出，形成周向消融的益处可能胜过肾动脉狭窄的可能性，或者说在某些实施例或在某些患者体内可以降低这种风险，从而可将建立周向消融作为目标。另外，神经调节设备的可变定位和重新定位在肾动脉特别曲折或在肾动脉主血管分出近枝血管的情况中可证明是有用的，所述情况使在某些位置的处理具有挑战性。
通过肾动脉的血流可能暂时性地短时闭塞，带来极少并发症或无并发症。然而，在一些情况下可避免长时间的闭塞，以减小对肾脏的损伤(例如缺血)的可能性。可能有利的是完全避免闭塞，或者在闭塞有利于某实施例时将闭塞的持续时间限制在例如2-5分钟。
基于上文描述的以下挑战：(1)肾动脉介入术，(2)处理元件抵靠血管壁的一致而稳定的放置，(3)横跨血管壁的处理的有效应用，(4)处理设备的定位和潜在重新定位以允许有多个处理位置，以及(5)避免或限制血流闭塞的持续时间，可能感兴趣的肾脉管系统的各种独立和依赖性质包括例如：(a)血管直径、血管长度、内膜-中膜厚度、摩擦系数和曲折度；(b)血管壁的可扩张性、刚度和弹性模量；(c)收缩期峰值、舒张末期血流流速、以及收缩舒张峰值血流流速均值和容积血流率的均值/最大值；(d)血液和/或血管壁的比热容、血液和/或血管壁的热导率、和/或经过血管壁处理部位的血流的热对流系数和/或辐射热传递；(e)由呼吸、患者移动和/或血流脉动性引起的相对于主动脉的肾动脉移动；以及(f)肾动脉相对于主动脉的离源角。将结合肾动脉更详细地讨论这些性质。然而，根据用来实现肾神经调节的设备、系统和方法，肾动脉的此类性质也可以指导和/或约束设计特性。
如上所述，定位在肾动脉内的设备可适形于该动脉的几何形状。肾动脉血管直径DRA通常在约2-10mm的范围内，大多数患者群的DRA为约4mm至约8mm，并且平均值为约6mm。肾动脉血管长度LRA在其主动脉/肾动脉接合点的口和其远端分枝处之间通常在约5-70mm的范围内，患者群中的很大一部分在约20-50mm的范围内。由于目标肾丛包埋在肾动脉的外膜内，内膜-中膜总厚度IMT(即，从动脉腔表面到包含目标神经结构的外膜的径向向外距离)也是值得注意的，并且通常在约0.5-2.5mm范围内，平均值为约1.5mm。尽管一定的处理深度对到达目标神经纤维可能是重要的，但可以防止处理变得过深(例如，距离肾动脉内壁>5mm)，以避开非目标组织和诸如肾静脉的解剖结构。
可能感兴趣的肾动脉的另一个性质是由呼吸和/或血流脉动性引起的相对于主动脉的肾运动程度。位于肾动脉远端的患者的肾脏可随着呼吸幅度而向颅侧移动多达4英寸。这可造成连接主动脉和肾脏的肾动脉的显著运动，从而需要从神经调节设备获得刚性和柔韧性的独有平衡，以在呼吸周期过程中保持热处理元件和血管壁之间的接触。此外，在肾动脉和主动脉之间的离源角可能在患者之间显著变化，并且也可能在同一患者体内例如由于肾运动而动态变化。离源角通常可以在约30°-135°的范围内。
IV.另外的示例
以下示例示出了本发明的技术的若干实施例。
1.一种导管设备，包括：
细长的管状轴，其具有近端部分和远端部分；以及
治疗组件，其设置在所述细长轴的所述远端部分处且适于位于人类患者的肾动脉内的目标位置处，所述治疗组件包括支撑结构，所述支撑结构包括：
控制构件，其包括预成形的螺旋形状，其中，所述控制构件为管状结构，所述管状结构具有穿过其中的管腔并且由镍钛诺多股绞丝构成；以及
多个能量递送元件，其由所述支撑结构承载，
其中，所述细长的管状轴和所述治疗组件一起限定穿过其中的导丝管腔，所述导丝管腔被构造成能滑动地接纳医用导丝，并且
其中，所述导丝相对于所述治疗组件的轴向移动使所述支撑结构在(a)低轮廓递送构型和(b)趋于呈现所述控制构件的所述预成形的螺旋形状的部署构型之间转变。
2.根据示例1所述的导管设备，其特征在于，所述治疗组件被构造成在所述低轮廓递送构型和所述部署构型之间转变，同时所述导丝的至少远端部分保持在所述治疗组件的所述导丝管腔中。
3.根据示例2所述的导管设备，其特征在于，所述支撑结构包括形状恢复力，当所述导丝的最远端顶端与所述治疗组件的远端顶端大体上对齐时，所述形状恢复力足以克服由所述导丝的远端区域提供的拉直力，以使所述治疗组件转变至所述部署构型。
4.根据示例1所述的导管设备，其特征在于：
所述支撑结构包括形状恢复力，当所述导丝位于所述治疗组件的所述导丝管腔内时，所述形状恢复力不足以克服由所述导丝的远端区域提供的拉直力；以及
所述治疗组件被构造成当所述导丝的最远端部分穿过所述导丝管腔撤出到所述治疗组件近端的点时转变至所述部署构型。
5.根据示例1至4中的任一项所述的导管设备，其特征在于，所述治疗组件的远端部分还包括柔性弯曲顶端，所述柔性弯曲顶端被构造成提供用于所述导丝的开口并且在所述部署构型中将所述导丝导向远离所述肾动脉的壁。
6.根据示例5所述的导管设备，其特征在于，所述柔性弯曲顶端由聚醚-酰胺嵌段共聚物构成。
7.根据示例5所述的导管设备，其特征在于，所述柔性弯曲顶端由热塑性聚醚型聚氨酯材料构成。
8.根据示例7所述的导管设备，其特征在于，所述柔性弯曲顶端由与所述热塑性聚醚型聚氨酯材料共混的约5至30重量％的硅氧烷构成。
9.根据示例1至8中的任一项所述的导管设备，其特征在于，在所述部署构型中，由所述支撑结构承载的所述能量递送元件沿所述肾动脉的纵向轴线彼此间隔开并被构造成与所述肾动脉的壁保持并置。
10.根据示例1至9中的任一项所述的导管设备，其特征在于，所述能量递送元件包括一系列带状电极。
11.根据示例10所述的导管设备，其特征在于，所述带状电极中的至少一个包括渐缩的端部，并且其中所述渐缩的端部被构造成在所述支撑结构的外表面与所述至少一个带状电极的外表面之间提供钝角。
12.根据示例1至11中的任一项所述的导管设备，其特征在于，所述治疗组件包括四个能量递送元件。
13.根据示例1至12中的任一项所述的导管设备，其特征在于，还包括能回缩的加载工具，所述加载工具围绕且约束处于所述低轮廓递送构型的所述治疗组件的至少纵向部分。
14.根据示例13所述的导管设备，其特征在于，所述加载工具包括具有倒圆边缘的远端部分。
15.一种用于人类患者的处理的肾神经调节系统，所述系统包括：
细长轴，其具有近端和远端，其中，所述轴的所述远端被构造成用于沿手术导丝在血管内递送至所述患者的肾动脉；
预成型的管状螺旋结构，其设置在所述细长轴的所述远端处或附近，其中，所述螺旋结构被构造成在未膨胀构型和膨胀构型之间转变，所述膨胀构型趋于呈现所述预成型的螺旋结构的形状，并且其中，所述螺旋结构至少部分地由多股镍诺钛绞丝构成；以及
多个电极，其与所述螺旋结构相关联，
其中，所述细长轴和所述螺旋结构一起限定穿过其中的导丝管腔，并且其中，
所述导丝管腔被构造成能滑动地接纳所述手术导丝，以便将所述螺旋结构定位在所述患者的肾血管内的目标处理部位处并将所述螺旋结构约束在所述未膨胀构型中，并且其中
所述手术导丝通过所述导丝管腔相对于所述螺旋结构的近端移动，以使所述导丝的远端部分至少部分地位于所述导丝管腔内，将所述螺旋结构转变至所述膨胀构型。
16.根据示例15所述的系统，其特征在于，所述手术导丝包括具有变化的柔韧性的远端部分，并且进一步地其中，所述导丝的所述远端部分的至少一区域被构造成当所述螺旋结构处于所述膨胀构型时保持在由所述螺旋结构所限定的所述导丝管腔的所述部分内。
17.根据示例15或示例16所述的系统，其特征在于，还包括柔性管，所述柔性管覆盖且与所述螺旋结构紧密接触。
18.根据示例17所述的系统，其特征在于，所述多个电极使用粘合剂材料粘结至所述柔性管。
19.根据示例15至18中的任一项所述的系统，其特征在于，所述多个电极由金构成。
20.根据示例15至19中的任一项所述的系统，其特征在于，所述多个电极能独立地连接到所述患者外部的能量源，并且其中，所述能量源能够在治疗期间独立地控制递送至每个电极的能量。
21.一种执行肾神经调节的方法，所述方法包括：
将处于低轮廓递送构型的肾神经调节导管在血管内沿导丝递送至人类患者的肾血管内的目标处理部位并且至少靠近所述患者的肾神经，其中，所述肾神经调节导管包括：
细长轴；以及
多电极阵列，其设置在所述轴的远端部分并且至少部分地由管状结构构成，所述管状结构由多线镍诺钛丝形成；
在近端方向上撤出所述导丝，直到所述导管从所述低轮廓递送构型转变至部署构型为止，其中，所述管状结构具有径向膨胀的大体上螺旋的形状，所述螺旋的形状被构造成接触所述肾血管的壁并允许血液流过所述血管；以及
选择性地递送能量至所述多电极阵列的一个或多个电极以抑制沿所述肾神经的神经通信。
22.根据示例21所述的方法，其特征在于，选择性地递送能量至所述多电极阵列的一个或多个电极包括沿着所述肾血管产生呈所需图案的多个病变部。
23.根据示例21或示例22所述的方法，其特征在于，所述多电极阵列的各个电极充分地间隔开，以便所述病变部不重叠。
24.根据示例21至23中的任一项所述的方法，其特征在于，还包括将外部地线附接到所述患者的外部，并且其中，选择性地递送能量至一个或多个电极还包括在所述电极中的每一个和所述外部地线之间以单极方式递送电场。
25.根据示例21至23中的任一项所述的方法，其特征在于，选择性地递送能量包括在所述多电极阵列的所述电极之间以双极方式选择性地递送电场。
26.根据示例21至25中的任一项所述的方法，其特征在于，在近端方向上撤出所述导丝直到所述治疗组件转变为止包括从所述治疗组件仅部分地撤出所述导丝，以便在所述治疗组件转变至所述部署构型之后所述导丝的至少一部分保持在所述治疗组件中。
27.根据示例21至25中的任一项所述的方法，其特征在于，在近端方向上撤出所述导丝直到所述治疗组件转变为止包括从所述治疗组件完全地撤出所述导丝，以便所述导丝的最远端部分被撤出到所述治疗组件近端的点。
28.根据示例21至27中的任一项所述的方法，其特征在于，所述目标处理部位包括第一目标处理部位，并且其中，所述方法还包括：
在选择性地递送能量至所述多电极阵列的所述一个或多个电极之后在远端方向上推进所述导丝以将所述多电极阵列从所述部署构型转变回所述低轮廓递送构型；
将所述导管重新定位在不同于所述第一处理部位的第二目标处理部位；
在近端方向上撤出所述导丝以将所述治疗组件再次从所述递送构型转变至所述部署构型；以及
选择性地递送能量至定位在所述第二目标处理部位处的所述多电极阵列的一个或多个电极。
V.结论
本技术的实施例的以上详细描述并非意图为穷举性的或将本技术限制到以上所公开的精确形式。虽然上文出于说明性目的而描述了本技术的具体实施例和示例，但如相关领域的技术人员将认识到那样，在本技术的范围内各种等同修改是可能的。例如，虽然各步骤以给定顺序提供，但备选实施例可以不同顺序来执行步骤。本文所述各种实施例也可结合以提供另外的实施例。
由上可知，应当理解，虽然本文出于说明性目的已描述了本技术的具体实施例，但熟知的结构和功能未被详细示出和描述，以免使本技术的实施例的描述不必要地变模糊。在上下文允许的情况下，单数或复数术语也可分别包含复数或单数。
此外，除非单词“或者”明确限于指仅一个物品，排除涉及两个或更多个物品列表的其它物品，那么这样的列表中使用的“或者”应解释为包含(a)列表中的任何单个物品，(b)列表中的所有物品，或(c)列表中物品的任何组合。另外，术语“包括”通篇用于指包含至少(多个)所叙述的特征，使得不排除更大数量的任何相同特征和/或附加类型的其它特征。也应理解本文出于说明目的而描述了具体实施例，但可以在不偏离本技术的情况下进行各种修改。此外，虽然与本技术的某些实施例相关联的优点已在那些实施例的上下文中进行了描述，但其它实施例也可以显示这样的优点，而且，不需要所有实施例都具有这样的优点以落在本技术的范围内。因此，本公开和相关联的技术可涵盖本文未明确示出或描述的其它实施例。

Claims (6)

1.一种用于人类患者的处理的肾神经调节系统，所述系统包括：
细长轴，其具有近端和远端，其中，所述轴的所述远端被构造成用于沿手术导丝在血管内递送至所述患者的肾动脉；
预成型的管状螺旋结构，其设置在所述细长轴的所述远端处或附近，其中，所述螺旋结构被构造成在未膨胀构型和膨胀构型之间转变，所述膨胀构型趋于呈现所述预成型的螺旋结构的形状，并且其中，所述螺旋结构至少部分地由多股镍诺钛绞丝构成；以及
多个电极，其与所述螺旋结构相关联，
其中，所述细长轴和所述螺旋结构一起限定穿过其中的导丝管腔，
其中，所述导丝管腔被构造成能滑动地接纳所述手术导丝，以便将所述螺旋结构定位在所述患者的肾血管内的目标处理部位处并将所述螺旋结构约束在所述未膨胀构型中，并且
其中，所述手术导丝通过所述导丝管腔相对于所述螺旋结构向近端移动以使所述导丝的远端部分至少部分地位于所述导丝管腔内，将所述螺旋结构转变至所述膨胀构型。
2.根据权利要求1所述的系统，其特征在于，所述手术导丝包括远端部分，所述远端部分具有沿其变化的柔韧性，并且进一步地其中，所述导丝的所述远端部分的至少一区域被构造成当所述螺旋结构处于所述膨胀构型时保持在所述导丝管腔的由所述螺旋结构所限定的部分内。
3.根据权利要求1所述的系统，还包括柔性管，所述柔性管覆盖所述螺旋结构且与所述螺旋结构紧密接触。
4.根据权利要求3所述的系统，其特征在于，所述多个电极使用粘合剂材料粘结至所述柔性管。
5.根据权利要求1所述的系统，其特征在于，所述多个电极由金构成。
6.根据权利要求1所述的系统，其特征在于，所述多个电极能独立地连接到患者外部的能量源，并且其中，所述能量源能够在治疗期间独立地控制递送至每个电极的能量。
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