CN103124536A - 用于肾神经消融的顺序激活rf电极组 - Google Patents

用于肾神经消融的顺序激活rf电极组 Download PDF

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CN103124536A
CN103124536A CN2011800468711A CN201180046871A CN103124536A CN 103124536 A CN103124536 A CN 103124536A CN 2011800468711 A CN2011800468711 A CN 2011800468711A CN 201180046871 A CN201180046871 A CN 201180046871A CN 103124536 A CN103124536 A CN 103124536A
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M·詹森
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Abstract

一种导管包括具有足以访问患者的肾动脉的长度的柔性轴。在所述轴的远侧端处的治疗元件针对在所述肾动脉内的部署来定尺寸。所述治疗元件包括被配置用于维持在所述肾动脉内的定位的可放射状地扩展的结构。多个电极在所述治疗元件上间隔开并且被配置用于按预定顺序可交换的激活和去激活，以产生对准所述肾动脉的血管周神经的重叠的加热区。所述重叠的加热区包括在与所述治疗元件相距一定距离的位置与足以消融所述血管周肾神经的相对高的电流密度关联的远侧区，以及与比所述远侧区的电流密度低并且不足以对邻近所述治疗元件的所述肾动脉的组织造成热损伤的电流密度关联的近侧区。

Description

用于肾神经消融的顺序激活RF电极组
发明内容
本公开内容的实施例一般地针对用于消融身体的靶组织的设备和方法。本公开内容的实施例针对用于消融诸如肾动脉和肾神经节的受神经支配的肾脉管系统的设备和方法。
根据各种实施例，一种设备包括导管，所述导管包括具有近侧端和远侧端的柔性轴。治疗元件被设置在所述轴的远侧端处。定位装置被设置在所述轴的远侧端处并且被配置用于在消融期间维持所述治疗元件相对于在治疗部位处的靶组织的定位。
限定电极组的多个电极相对于彼此被布置在所述治疗元件处。所述电极组被配置用于按预定顺序可切换的激活和去激活，以产生对准所述靶组织的重叠的加热区。
在一些实施例中，所述加热区重叠以限定在与所述治疗元件相距一定距离的位置与足以消融靶组织的大体上连续的欧姆加热关联的远侧区和与对在邻近所述治疗元件的所述治疗部位处的组织不造成热损伤或造成可忽略的热损伤的间歇欧姆加热关联的近侧区。优选地，所述近侧区具有比所述远侧区少的重叠电流路径。
在其他实施例中，所述近侧区内的加热低于造成在邻近所述治疗元件的所述治疗部位处的组织的凝固性坏死所需的温度。举例来说并且依照另外的实施例，所述近侧区内的加热不足以使邻近所述治疗元件的组织的温度升高到高于大约50℃。
在一些实施例中，所述加热区重叠以限定在与所述治疗元件相距一定距离的位置与足以消融所述靶组织的相对高的电流密度关联的远侧区和与比所述远侧区的电流密度低的对在邻近所述治疗元件的所述治疗部位处的组织不造成热损伤或造成可忽略的热损伤的电流密度关联的近侧区。
在其他实施例中，所述多个加热区中的至少一些基于所述电极组的激活和去激活在所述治疗元件处具有空间上分开的起端。所述加热区中的每一个都包括在与所述治疗元件相距一定距离的位置具有足以消融所述靶组织的大体上连续的欧姆加热的远侧区。所述加热区中的每一个都还包括在贴近所述治疗元件的位置具有对在邻近所述治疗元件的所述治疗部位处的组织不造成热损伤或造成可忽略的热损伤的间隙欧姆加热的近侧区。
依照各种实施例，一种设备包括导管，所述导管包括具有近侧端、远侧端以及相对于经皮位置足以访问患者的肾动脉的长度的柔性轴。治疗元件被设置在所述轴的远侧端处并且针对在所述肾动脉内的部署来定尺寸。所述治疗元件包括被配置用于维持所述治疗元件在所述肾动脉内的定位的可扩展结构。
限定电极组的多个电极相对于彼此被布置在所述治疗元件处。所述电极组被配置用于按预定顺序可切换的激活和去激活，以产生对准所述肾动脉的血管周神经的重叠的加热区。所述加热区重叠以限定在与所述治疗元件相距一定距离的位置与足以消融所述血管周肾神经的相对高的电流密度关联的远侧区和与比所述远侧区的电流密度低的对邻近所述治疗元件的所述肾动脉的组织不造成热损伤或造成可忽略的热损伤的电流密度关联的近侧区。
电导体装置沿所述导管的轴延伸并且与所述电极组耦合。温度传感器装置被设置在所述治疗元件处并且与所述电导体装置耦合。所述温度传感器装置被配置用于感测所述电极组的温度。
根据另外的实施例，可以实现用于在消融期间维持治疗元件相对于在所述身体的治疗部位处的靶组织的定位的方法。所述治疗元件优选地包括限定电极组并且相对于彼此被布置在所述治疗元件处的多个电极。所述方法还涉及按预定顺序可切换地激活和去激活所述电极以产生对准所述靶组织的重叠的加热区。
在一些实施例中，所述加热区重叠以限定在与所述治疗元件相距一定距离的位置与足以消融所述靶组织的相对高的电流密度关联的远侧区和与比所述远侧区的电流密度低的对在邻近所述治疗元件的所述治疗部位处的组织不造成热损伤或造成可忽略的热损伤的电流密度关联的近侧区。
在其他实施例中，所述加热区中的至少一些基于所述电极组的激活和去激活在所述治疗元件处具有空间上分开的起端。所述加热区中的每一个都包括在与所述治疗元件相距一定距离的位置具有大体上连续的欧姆加热并且足以消融所述靶组织的远侧区和在贴近所述治疗元件的位置具有对在邻近所述治疗元件的所述治疗部位处的组织不造成热损伤或造成可忽略的热损伤的间歇欧姆加热的近侧区。
这些及其他特征能够考虑以下具体论述和附图来理解。
附图说明
图1是右肾和包括从腹主动脉横向分路的肾动脉的肾脉管系统的示意；
图2A和2B示意了肾动脉的交感神经分布；
图3A示意了肾动脉的壁的各种组织层；
图3B和3C示意了肾神经的一部分；
图4A示意了依照各种实施例的包括支承按一个或多个电极组布置的多个RF电极的治疗元件的导管；
图4B是依照各种实施例的在图4A中所示出的导管的轴的横截面；
图5示意性地示出了依照各种实施例的来自位于导管的治疗元件上的电极组的每个独立的RF电极的重叠的加热区，该重叠的加热区包括用于神经消融的最大加热的区域和在动脉壁处的较冷区域；
图6示出了依照各种实施例的、电极组的以间隔开的关系位于导管的可扩展结构的一部分上的代表性的一组电极；
图7是示出了依照各种实施例的位于可扩展结构的一部分上的多个电极和温度传感器以及外部控制系统的各个部件的框图；以及
图8示出了依照本公开内容的各种实施例的代表性的RF肾治疗设备。
具体实施方式
一般而言，当为用于对高血压的治疗的血管周肾神经消融使用放置在肾动脉中的(一个或多个)RF电极时，最高的电流密度以及因此最大的加热通常邻近典型地位于肾动脉的内腔内的电极。为了得到用于肾神经的有效消融的组织温度，肾动脉也被损伤。可以提供主动式冷却，但需要更大的导管和更复杂的系统。
本公开内容的实施例针对改进的RF消融导管、系统以及方法。在本文中所公开的设备针对使用电流的、改进的消融导管和系统。本公开内容的实施例针对用于为对高血压的治疗而消融血管周肾神经的设备和方法。
高血压是其中血压升高的慢性医学状况。持久性高血压是与各种不利的医学状况关联的显著风险因素，所述不利的医学状况包括心脏病发作、心力衰竭、动脉瘤以及中风。持久性高血压是慢性肾衰竭的主因。服务肾的交感神经系统的功能亢进与高血压及其进展关联。肾中的神经经由肾去神经支配的去激活能够降低血压，并且对于对常规药物无反应的具有高血压的许多患者而言可能是可行的治疗选择。
肾在许多身体过程中起作用，包括血液过滤、体液平衡的调节、血压控制、电解质平衡以及激素产生。肾的一个主要功能在于从血液中去除毒素、矿物盐和水以形成尿液。肾通过从腹主动脉左右分路的肾动脉接收心脏出量的大约20%-25%，在肾的凹面，即肾门处进入每个肾。
血液通过肾动脉和传入小动脉流入肾，进入肾的过滤部分，即肾小体。肾小体由肾小球、丛生的毛细血管构成，被称作包曼囊的、充满液体的杯状囊围绕。由于存在于毛细血管中的血液与包曼囊中的液体之间的压力梯度的原因，血液中的溶质通过肾小球的非常薄的毛细血管壁被过滤。压力梯度由小动脉的收缩或扩张来控制。在过滤发生之后，经过滤的血液移动通过传出小动脉和管周毛细血管，会聚在小叶间静脉中，并且最后通过肾静脉排出肾。
从血液中过滤的微粒和液体通过多个小管从包曼囊移动到收集管。尿液在该收集管中形成，并且进而通过输尿管和膀胱排出。小管被管周毛细血管(包含经过滤的血液)围绕。随着滤出液通过小管并且朝收集管移动，营养物、水以及诸如钠和氯化物的电解质被重新吸收到血液中。
肾由主要从主动脉肾神经节发散的肾丛进行神经支配。随着神经沿肾动脉的路线前进并且到肾中，肾神经节由肾丛的神经形成。肾神经是包括交感神经和副交感神经成分的自主神经系统的部分。已知交感神经系统是向身体提供“战逃”反应的系统，而副交感神经系统提供“休息与消化”反应。交感神经活动的刺激触发使肾增加激素产生的交感反应，所述激素增加血管收缩和体液潴留(fluid retention)。这个过程被称为对增加的肾交感神经活动的肾素-血管紧张素-醛固酮-系统(RAAS)反应。
响应于血量的减少，肾分泌肾素，其刺激血管紧张素的产生。血管紧张素使血管收缩，引起血压升高，并且还刺激来自肾上腺皮质的激素醛固酮的分泌。醛固酮使肾的小管增加了对钠和水的重新吸收，这提高了身体中的液体量以及血压。
充血性心力衰竭(CHF)是与肾功能相联系的状况。CHF发生在心脏不能够遍及身体有效地泵送血液的时候。当血流量下降时，肾功能因为血液在肾小体内不足的灌注而衰退。到肾的减少的血流量触发交感神经系统活动的增加(即RAAS变得太活跃)，其使肾分泌增加体液潴留和血管收缩的激素。体液潴留和血管收缩进而增加循环系统的外围阻力，使心脏承受甚至更大的负荷，这进一步使血流量变小。如果心脏和肾功能的衰退继续，则最终身体变得不堪重负，并且心力衰竭代偿失调的一幕发生，常常导致患者住院治疗。
图1是右肾10和包括从腹主动脉20横向分路的肾动脉12的肾脉管系统的示意。在图1中，出于说明的简单性的目的仅示出了右肾10，但将在本文中对左右两个肾以及关联的肾脉管系统和神经系统结构进行参考，所有这些都在本公开内容的实施例的背景下被想到。肾动脉12被故意示出为不成比例地大于右肾10和腹主动脉20，以便有助于本公开内容的各种特征和实施例的论述。
从左右肾动脉向左右肾供血，所述左右肾动脉从腹主动脉20的相应的左右侧面分路。左右肾动脉中的每一个都跨横隔膜的脚(crus)被定向，以便差不多与腹主动脉20形成直角。左右肾动脉通常从腹主动脉20延伸到贴近肾的门脐17的相应的肾窦，并且分路到段动脉中以及进而到肾10内的小叶间动脉中。小叶间动脉向外辐射，穿透肾小体并且延伸通过肾锥体之间的肾柱。典型地，肾接收总心脏输出的大约20%，这对于正常人而言表示每分钟大约1200 mL的血流量通过肾。
肾的主要功能是通过控制尿液的产生和浓度来维持身体的水和电解质平衡。在产生尿液时，肾分泌诸如尿素和铵的废物。肾还控制葡萄糖和氨基酸的重新吸收，并且在包括维生素D、肾素以及红细胞生成素的激素的产生方面是重要的。
肾的重要的第二功能是控制身体的新陈代谢体内平衡。控制止血功能包括调节电解质、酸基平衡以及血压。例如，肾负责通过例如调节在尿液中损失的水量并且释放红细胞生成素和肾素来调节血量和血压。肾还通过控制在尿液中损失的量以及钙的合成来调节血浆离子浓度(例如钠、钾、氯离子以及钙离子水平)。由肾控制的其他止血功能包括通过控制尿液中的氢和碳酸氢盐离子的损失来稳定血液的pH值、通过阻止它们的排泄来保存有价值的营养物以及协助肝脏解毒。
同样在图1中示出的是右肾上的腺11，其通常被称为右肾上腺。肾上腺11是保持在肾10之上的星状内分泌腺。肾上腺(左和右)的主要功能是通过分别包括皮质醇和肾上腺素(adrenaline)(肾上腺素(epinephrine))的皮质类固醇与儿茶酚胺的合成来调节身体的应激反应，包围肾10、肾上腺11、肾管12以及邻近的肾周脂肪的是肾筋膜，例如杰氏筋膜(Gerota's fascia)(未示出)，其为源自于腹膜外结缔组织的筋膜陷凹。
身体的自主神经系统控制血管、消化系统、心脏以及腺中的平滑肌的无意识的动作。自主神经系统被划分成交感神经系统和副交感神经系统。一般而言，副交感神经系统通过降低心率、降低血压以及刺激消化使身体为休息做好准备。交感神经系统通过提高心率、提高血压以及提高新陈代谢来实现身体的战逃反应。
在自主神经系统中，从中央神经系统发源并且延伸到各个神经节的纤维被称为神经节前纤维，而从神经节向效应器官延伸的那些纤维被称为神经节后纤维。交感神经系统的激活通过肾上腺素(adrenaline)(肾上腺素(epinephrine))的释放并且在较小程度上通过来自肾上腺11的降肾上腺素的释放来实现。肾上腺素的这种释放由从神经节前交感神经所释放的神经递质乙酰胆碱触发。
肾和输尿管(未示出)由肾神经14进行神经支配。图1和2A-2B示意了肾脉管系统的交感神经神经分布，主要是肾动脉12的神经分布。肾脉管系统的交感神经神经支配的主要功能包括肾血流量和血压的调节、肾素释放的刺激以及水和钠离子重新吸收的直接刺激。
对肾脉管系统进行神经支配的大多数神经是产生自肠系膜上神经节26的交感神经节后纤维。肾神经14沿肾动脉12大体上轴向地延伸，在门脐17处进入肾10，沿肾10内的肾动脉12的分支前进并且延伸到各个肾元。诸如肾神经节24、肠系膜上神经节26、左右主动脉肾神经节22以及腹腔神经节28的其他肾神经节还对肾脉管系统进行神经支配。腹腔神经节28被较大的胸内脏神经(较大的TSN)连接起来。主动脉肾神经节26被较小的胸内脏神经(较小的TSN)连接起来并且对肾丛的较大部分进行神经支配。
肾10的交感神经信号经由主要在脊髓节段T10-T12和L1处发源的受神经支配的肾脉管系统来传送。副交感神经信号主要在脊髓节段S2-S4处以及从下脑(lower brain)的延髓发源。交感神经通信量行进通过交感神经干线神经节，其中一些可以形成突触，而其他的在主动脉肾神经节22(经由较小的胸内脏神经，即较小的TSN)和肾神经节24(经由最小的胸内脏神经，即最小的TSN)处形成突触。突触后交感神经信号进而沿肾动脉12的神经14向肾10行进。突触前副交感神经信号在它们在肾10上或附近形成突触之前行进到肾10附近的部位。
特别地参照图2A，如同大多数动脉和小动脉一样，肾动脉12内衬有控制肾动脉内腔13的直径的平滑肌34。平滑肌通常是在大的和小的动脉和静脉的中膜层以及各种器官内发现的无意识的非横纹肌。肾的肾小球例如包含被称作肾小球系膜细胞的平滑肌状细胞。平滑肌在结构、功能、刺激-收缩耦合以及收缩机制方面根本上不同于骨骼肌和心肌。
平滑肌细胞可以被自主神经系统刺激来收缩或放松，但也能够对来自相邻细胞的刺激作出反应以及响应于激素和血液承载的电解质和药剂(例如血管舒张药或血管收缩剂)作出反应。例如肾10的肾小球旁器的传入小动脉内的专门的平滑肌细胞产生激活血管紧张素II系统的肾素。
肾神经14对肾动脉壁15的平滑肌34进行神经支配并且沿肾动脉壁15以大体上轴向或纵向的方式纵长地延伸。平滑肌34环向地围绕肾动脉并且在大体上横向于肾神经14的纵向取向的方向上纵长地延伸，如在图2B中所描绘的那样。
肾动脉12的平滑肌34处于自主神经系统的无意识控制下。例如，交感神经活动的增加趋于使平滑肌34收缩，这缩小肾动脉内腔13的直径并且减少血液灌注。交感神经活动的减少趋于使平滑肌34放松，导致血管扩张以及肾动脉内腔直径和血液灌注的增加。相反地，增加的副交感神经活动趋于使平滑肌34放松，而减少的副交感神经活动趋于造成平滑肌收缩。
图3A示出了通过肾动脉的一段纵向截面并且示意了肾动脉12的壁15的各种组织层。肾动脉12的最内层是内皮30，其为内膜32的最内层并且由内部的弹性膜支承。内皮30是接触流过脉管内腔13的血液的单层细胞。内皮细胞通常为多角形、卵形或纺锤形，并且具有非常独特的圆形或卵形核。内皮30的细胞涉及若干脉管功能，包括借助于血管收缩和血管扩张对血压的控制、血液凝结以及被用作内腔13内的内含物与周围组织之间的阻挡层，所述周围组织诸如为使内膜32与中膜34分离的内膜32的膜以及外膜36。内膜32的膜或浸软是细密、透明、无色的结构，其为高度弹性的，并且通常具有纵向的波纹图案。
邻近内膜32的是中膜33，其为肾动脉12的中间层。中膜由平滑肌34和弹性组织组成。中膜33能够通过它的颜色以及通过它的纤维的横向布置容易地识别。更具体地，中膜33主要由成束的平滑肌纤维34构成，所述成束的平滑肌纤维34按薄板状的方式或薄层布置并且成环形地部署在动脉壁15周围。肾动脉壁15的最外层是外膜36，其由结缔组织组成。外膜36包括在伤口愈合时起重要作用的成纤维细胞38。
血管周区域37被示出为邻近肾动脉壁15的外膜36并且处于肾动脉壁15的外膜36的外围。肾神经14被示出为贴近外膜36并且穿过血管周区域37的一部分。肾神经14被示出为沿肾动脉12的外壁15大体上纵向地延伸。肾神经14的主干通常位于肾动脉12的内膜36中或肾动脉12的内膜36上，常常穿过血管周区域37，其中某些分支前进到中膜33中以消弱肾动脉平滑肌34。
本公开内容的实施例可以被实现以向受神经支配的肾脉管系统提供不同程度的去神经支配治疗。例如，本公开内容的实施例可以提供对通过使用本公开内容的治疗设备所输送的去神经支配治疗所得到的肾神经脉冲传输中断的程度和相对持久性的控制。肾神经损伤的程度和相对持久性可以满足得到交感神经活动的所期望的减少(包括部分或完全阻断)的需要并且满足得到所期望程度的持久性(包括暂时性的或不可逆的损伤)的需要。
返回图3B和3C，图3B和3C所示的肾神经14的部分包括各自包括轴突或树突的神经纤维14b的束14a，所述轴突或树突在位于神经节中或脊髓上或脑中的细胞体或神经元上发源或终止。神经14的支承组织结构14c包括神经内膜(围绕神经轴突纤维)、神经束膜(围绕纤维集合以形成肌束)以及神经外膜(将肌束结合到神经中)，所述支承组织结构14c被用于分开并且支承神经纤维14b和束14a。特别地，还被称为神经内膜管或小管的神经内膜是将神经纤维14b的髓鞘包封在纤维束内的一层精细的结缔组织。
神经元的主要成分包括体细胞，所述体细胞是神经元的包括细胞核、被称作树突的细胞伸展以及轴突的中心部分，所述轴突是携载神经信号的绳索状凸出部分。轴突末梢包含突触，所述突触是其中神经递质化学物质被释放以便与靶组织进行通信的专门的结构。外围神经系统的许多神经元的轴突被包覆在髓鞘内，所述髓鞘由称为雪旺细胞(Schwann cell)的一类神经胶质细胞形成。有髓鞘的雪旺细胞被包裹在轴突周围，使轴膜在有规则地间隔开的结(被称作朗飞氏结)处相对地不被覆盖。轴突的髓鞘化实现被称作突变的特别迅速的电脉冲传播模式。
在一些实施例中，本公开内容的治疗设备可以被实现以输送对肾神经纤维14b造成瞬时且可逆损伤的去神经支配治疗。在其他实施例中，本公开内容的治疗设备可以被实现以输送对肾神经纤维14b造成更严重损伤的去神经支配治疗，如果治疗被及时终止则这可以是可逆的。在优选实施例中，本公开内容的治疗设备可以被实现以输送对肾神经纤维14b造成严重且不可逆损伤的去神经支配治疗，导致肾交感神经活动的永久停止。例如，治疗设备可以被实现以输送使神经纤维形态中断到足以使神经纤维14b的神经内膜管在物理上分开的程度的去神经支配治疗，这能够阻止再生和再神经支配过程。
通过示例并且依照如在本领域中所知的Seddon分类，本公开内容的治疗设备可以被实现以输送去神经支配治疗，所述去神经支配治疗通过给予肾神经纤维14b与神经失用症一致的伤害来中断神经脉冲沿肾神经纤维14b的传导。神经失用症描述了其中不存在神经纤维14b或其髓鞘的破坏的神经伤害。在这种情况下，在神经脉冲向下沿神经纤维的传导中存在中断，其中恢复在数小时到数月内发生而不存在真正的再生，这是因为沃勒变性没有发生。沃勒变性指的是其中轴突的与神经元的细胞核分开的部分变性的过程。这个过程还被称为顺行性变性。神经失用症是可以通过使用根据本公开内容的实施例的治疗设备给予肾神经纤维14b的神经损伤的最温和的形式。
治疗设备可以被实现以通过给予肾神经纤维与轴突断伤一致的伤害来中断神经脉冲沿肾神经纤维14b的传导。轴突断伤涉及神经纤维的轴突及其髓鞘覆盖的相对连续性的丧失，但神经纤维的结缔组织框架被保存。在这种情况下，神经纤维14b的封装支承组织14c被保存。因为失去轴突连续性，所以沃勒变性发生。从轴突断伤恢复仅通过轴突的再生来发生，该过程需要约数周或数月的时间。在电学上，神经纤维14b示出了迅速且完全的变性。只要神经内管是完好的，再生和再神经支配就可以发生。
治疗设备可以被实现以通过给予肾神经纤维14b与神经断伤一致的伤害来中断神经脉冲沿肾神经纤维14b的传导。根据Seddon分类，神经断伤是本方案中最严重的神经损伤。在这类损伤中，神经纤维14b和神经鞘两者被破坏。虽然部分恢复可能发生，但完全恢复是不可能的。在肾神经纤维14b的情况下，神经断伤涉及轴突和封装结缔组织14c的连续性的丧失，导致自主功能的完全丧失。如果神经纤维14b已完全分裂，则轴突再生使神经瘤形成在近侧残端中。
可以参考如在本领域中所知的Sunderland系统找到神经断伤性神经伤害的更多层次的分类。Sunderland系统定义了五种程度的神经伤害，其中前两个与Seddon分类的神经失用症和轴突断伤紧密地对应。后三个Sunderland系统分类描述了不同水平的神经断伤性神经伤害。
Sunderland系统中的第一程度和第二程度的神经损伤分别与Seddon分类的神经失用症和轴突断伤类似。根据Sunderland系统，第三程度的神经损伤涉及神经内膜的破坏，其中神经外膜和神经束膜保持完好。取决于束中纤维化的程度，恢复可以在差到完全的范围内。第四程度的神经损伤涉及所有神经和支承要素的中断，其中神经内膜保持完好。神经通常被扩大。第五程度的神经损伤涉及神经纤维14b的完全横断，其中连续性被丧失。
本公开内容的实施例针对提供在肾神经的消融期间减少对肾动脉的损伤的改进方式的设备和方法。各种实施例针对用于当在靶组织附近进行消融时减少对身体的其他组织和结构的损伤的设备和方法。这样的其他身体组织、结构以及靶组织的示例包括器官、肿瘤、患病组织以及诸如肺部静脉的、心脏的脉管系统或者用于治疗心律病状的电激活靶心脏组织。
本公开内容的实施例针对用于使用电流为高血压的治疗消融血管周肾神经的设备和方法。如先前所论述的那样，当使用放置在肾动脉中的RF电极时，最高的电流密度以及因此最大的加热和损伤的区域通常邻近电极。本公开内容的实施例提供了靶神经的充分消融，而同时通过在一组附近的RF电极之间移动电流来减少对肾动脉的损伤。
根据各种实施例，当一个电极被激活时，邻近其他电极的动脉壁部分能够冷却。电流被切换到组中的不同电极，允许邻近第一电极的动脉壁部分冷却。电流稍微在血管周组织中扩散，使得通过激活组中的每个电极所加热的区域重叠，阻止靶组织的冷却。
现在参考图4A，包括用于消融治疗部位的靶组织的多个可顺序激活的RF电极的导管100被示意。图4A是出于说明的目的所提供的简化示意表示。应理解的是，贯穿充气囊102的内腔可以被用于导线通过，而同时维持充气囊膨胀，并且导线孔111是这个内腔的远侧端的示意表示。
根据一些实施例，导管100包括具有近侧端和远侧端的柔性轴104。治疗元件101被设置在轴104的远侧端处。定位装置102被设置在轴204的远侧端处并且被配置用于在消融期间维持治疗元件101相对于在治疗部位处的靶组织的定位。定位装置102优选地包括可放射状地扩展的结构103，诸如充气囊或网格结构。在图4A所示的实施例中，治疗装置101和定位装置102被并置在公共结构(例如可扩展结构103)上。在其他实施例中，治疗装置101和定位装置102能够位于导管100的独立的结构上。
根据一些实施例，导管100的轴104具有相对于经皮位置足以访问患者的肾动脉12的长度。设置在轴204的远侧端处的治疗元件101针对在肾动脉12内的部署来定尺寸。治疗元件101包括被配置用于维持治疗元件101在肾动脉12内的定位的可放射状地扩展的结构103，诸如充气囊或网格结构。
图4B示出了图4A的导管100的轴104的横截面，其包括电极导体内腔113a、传感器导体内腔113b、导线内腔111、供应内腔106以及返回内腔108。供应内腔106和返回内腔108分别在膨胀和缩小操作期间向充气囊102输送以及从充气囊102去除加压流体。
电极和传感器导体内腔113a、113b可以各自包括一层电绝缘材料和/或置于其中的导体可以各自包括绝缘层。在各种实施例中，给定电极组119的电极120中的每一个都经由延伸通过电极导体内腔113a的单个电导体连接到导管100的电导体装置110。
温度传感器装置121在图4A中被示出，并且包括分布在电极组119内的多个温度传感器123。温度传感器装置121被配置用于感测在电极120的组119处或贴近其处的温度。给定温度传感器装置121的温度传感器123中的每一个都经由延伸通过传感器导体内腔113b的单个电导体连接到导管100的电导体装置110。电导体装置110沿轴104延伸到导管100的近侧端。
应注意的是，每个电极120不需要具有关联的温度传感器123，并且可以针对电极组119部署一个、两个或几个(即其数量少于电极120的数量的)温度传感器123。在一些实施例中，例如考虑到由电极120的组119的时间激活和空间位置布置所提供的、在电极-组织界面处的局部冷却，温度感测不被使用。
导线内腔111被定尺寸以容纳导线或能够被临床医生用于促进充气囊102到诸如肾动脉的所期望的治疗位置中的输送的其他细长的导航辅助构件。在图4A所示的配置中，导线内腔111限定了充气囊102的开口内腔，这例如允许导线通过其前进以用于将充气囊102导航到肾动脉。在导线被定位在肾动脉内之后，充气囊导管100沿导线前进并且使用线上输送技术被输送到肾动脉的内腔。
如图4A和5所示出的那样，多个电极120限定了电极组119并且相对于彼此被布置在治疗元件101处。电极组119的电极120被配置用于按预定顺序可交换的激活和去激活，以产生对准靶组织的重叠的加热区240。例如，电极组内的各个电极能够按预定顺序被通电，或者组内的多个电极能够同时地被通电，诸如电极1和3，接着是2和4，依此类推。电极的通电在时间上能够部分地重叠。特定电极能够使用不同的电波形来通电，以增强靶组织加热，而同时减少动脉壁损伤。图5示意性地示出了来自每个独立的RF电极120的重叠的加热区域，以及用于神经消融的最大加热的区域，以及在动脉壁处的较冷区域。
在图5中应注意的是，打阴影的圆锥体被用于示意性地表示较高电流密度的区域。应理解的是，实际的场和电流线更复杂并且取决于多个因素，包括各种组织的阻抗以及(一个或多个)返回电极的位置(例如外部的皮肤垫或在双极布置被使用的情况下为第二电极)。
图5示意了动脉壁上具有较少重叠电流路径的区域，其由于间隙加热而较冷以及在离开短距离的靶组织中具有更多连续电流和更大加热的区域。例如，图5中的加热区240重叠以限定远侧区250，其在与治疗元件101相距一定距离的位置与足以消融靶组织的相对高的电流密度关联，以及近侧区260，其与比远侧区的电流密度低的对在邻近治疗元件101的治疗部位处的组织不造成热损伤或造成可忽略的热损伤的电流密度关联。
与近侧加热区260关联的电流密度优选地低于在邻近治疗元件101的治疗部位处造成组织的凝固性坏死所需的电流密度。例如，与近侧加热区260关联的电流密度优选地不足以使邻近治疗元件101的组织加热到高于大约50℃的温度。与此相比，与远侧加热区250关联的电流密度优选地足以使靶组织加热到至少大约55℃的温度。
依照各种实施例，加热区240中的至少一些基于电极120的组119的选择性激活和去激活在治疗元件101处具有空间上分开的起端。加热区240中的每一个都包括在与治疗元件101相距一定距离的位置具有大体上连续的欧姆加热并且足以消融靶组织的远侧区250。加热区240中的每一个还包括在贴近治疗元件101的位置具有对在邻近治疗元件101的治疗部位处的组织不造成热损伤或造成可忽略的热损伤的间歇欧姆加热的近侧区260。
根据一些实施例，电极组119的电极120被配置用于按预定顺序可交换的激活和去激活，以产生对准肾动脉12的血管周神经的重叠的加热区240。加热区240重叠以限定在与治疗元件101相距一定距离的位置与足以消融血管周肾神经的相对高的电流密度关联的远侧区250，以及与比远侧区250的电流密度低的对邻近治疗元件101的肾动脉12的组织不造成热损伤或造成可忽略的热损伤的电流密度关联的近侧区260。
在各种实施例中，电极120的组119的时间激活布置和空间位置布置能够被选择以不伤害肾动脉壁的实质部分，即使在位于紧邻电极120处的肾动脉组织经受热损伤的情况下也是如此。因此，仅有可忽略百分比的肾动脉组织(即位于紧邻电极120处的小百分比的肾动脉组织)在消融期间经受可能的热损伤。
在一些实施例中，除由电极120的组119的时间激活和空间位置布置所提供的冷却之外，可能所期望的是包括增强在电极-组织界面处的局部冷却的冷却装置。血液灌注内腔能够被结合在治疗元件101中或上，并且被用于在血管周肾神经的消融期间为肾动脉12的壁提供冷却。例如，冷却内腔装置能够被配置用于对穿过肾动脉12的血液进行分流，以在消融期间冷却由治疗元件101所支承的电极。
在一些实施例中，冷却装置可以构成内建到治疗元件101中的纵向或螺旋形通道或凹槽。穿过通道或凹槽的血液被用于在消融期间增强肾动脉12的壁的冷却。被动式或主动式冷却机构能够协同地增强由本公开内容的实施例所提供的动脉壁保护。
根据一些方法，能够执行试验以确定激活顺序和功率设定的哪些组合证明是有效的，从这个组合能够建立和使用标准激活方案。简单的温度测量或电测量(例如阻抗、电流或电压感测或其组合)能够与标准激活方案相结合以得到有限的自定义或调整，诸如使用标准顺序以及功率比和定时，通过使用简单的温度或电测量仅在幅度或时间上进行比例调整。
现在参考图6，电极120的代表性的组119被示出以间隔开的关系位于可扩展结构103的一部分上。温度传感器装置121紧靠电极120的组119位于可扩展结构103上。如图6所示，温度传感器装置121的单个温度传感器123位于贴近电极组119的电极120中的每一个的位置。
如图5和6所示出的那样，诸如热电偶的一个或多个温度传感器123被设置在电极组119的位置以测量电极组119的温度。在一些实施例中，温度传感器123被定位在电极组123的每个电极120附近或其位置上，从而允许在消融电极装置101的各个电极位置处进行精确的温度测量。
一组电导体127被布置在可扩展结构102上，以用于建立电极组119中的每个电极120与外部电极激活电路之间的电连接。一组电导体129被布置在可扩展结构103上，以用于建立温度传感器装置121中的每个温度传感器123与外部温度传感器电路之间的电连接。
在一些实施例中，电导体127和129可以与被用于构建可扩展结构103(例如充气囊)的非导电聚合物材料以及适当的掩模相结合地使用金属化层来形成。在其他实施例中，电导体127和129可以与非导电材料或涂层以及适当的掩模相结合地使用导电线网格来形成。在另外的实施例中，电线网格结构可以是电线网格或者编织物或篮筐结构。取决于具体实现的电气特征，电线网格结构能够包括绝缘的或非绝缘的导电线或者非导电或聚合结构或者其组合。
在一种配置中，八个单极电极123的组119被附在可扩展充气囊或电线网格结构103上以维持在肾动脉内的定位。电导体127的组被连接到按顺序激活每个RF电极120以允许动脉12的冷却，但在靶组织中维持所期望的加热的外部电极激活电路。能够使用其他数量的电极，诸如按顺序1-3-5-2-4并且重复被激活的一组五个电极，或者针对最大动脉冷却所选择的其他顺序。
位于肾动脉壁上的其他区域处的电极123的一个或多个附加的组119能够被用于消融血管周肾神经的不同部分，或者导管和/或可扩展结构103能够被移动到不同的位置并且再次被激活。
根据各种实施例，能够使用双极电极组，混合被激活的电极123的位置以维持靶组织的加热，但允许动脉间歇地加热和冷却以使动脉损伤最小化。类似方法能够与其他加热机制一起使用以按邻近位置的顺序产生热量，所述邻近位置相交以创建用于消融靶组织的加热区和用于保护动脉12的较冷区。诸如针对肿瘤消融或BPH(良性前列腺增生)治疗，类似方法能够被用于消融离开短距离的靶组织，同时保护较靠近加热装置的组织。
图7是示出了依照各种实施例的、位于可扩展结构103的一部分上的多个电极和温度传感器以及外部控制系统的各个部件的框图。在一些实施例中，可能所期望的是使用置于导管101的可扩展结构103上的一个以上的电极组119。两个、三个或四个电极组119可以在不同的纵向和环向位置处位于可扩展结构103上。例如，在可扩展结构103上各自覆盖不同的90°的弧的四个偏置的电极组119能够被部署以限定大体上为螺旋形的形状。进一步举例来说，在可扩展结构103上各自覆盖不同的120°的弧的三个电极组119能够被部署以限定大体上为环形的形状。
图7所示的可扩展结构103的部分包括多个电极组119a-119n，其中每一个都包括若干独立受控的电极120。电极组119a-119n中的每一个都与外部电极激活电路320电耦合。如先前所论述的那样，每个电极组119a-119n中的每个电极120都独立地与外部电极激活电路320耦合。
图7所示的可扩展结构103的部分还包括多个温度传感器阵列121a-121n，其中每一个都包括若干独立的温度传感器123。温度传感器阵列121a-121n中的每一个都与外部温度测量电路328电耦合。每个温度传感器阵列121a-121n中的每个温度传感器123都独立地与外部温度测量电路328耦合。
外部温度测量电路328与外部电极激活电路320耦合。每个温度传感器阵列121a-121n中的每个温度传感器123的温度信息由外部温度测量电路328提供给外部电极激活电路320。外部电极激活电路320包括功率控制322和定时控制324。部分地基于所接收的温度信息，外部电极激活电路320控制每个电极组119a-119n中的每个电极123的激活顺序以及提供给每个电极组119a-119n中的每个电极123的RF能量的量。
图8示出了依照本公开内容的各种实施例的代表性的RF肾治疗设备300。图8所示的设备300包括外部电极激活电路320，其包括功率控制电路322和定时控制电路324。包括RF发生器的外部电极激活电路320与温度测量电路328耦合并且可以与可选的阻抗传感器326耦合。导管100包括轴104，所述轴104结合被配置用于容纳各种部件的内腔装置105，所述各种部件诸如为导体、膨胀流体、药理试剂、制动器元件、充填体、传感器或者根据需要或期望的其他部件。
外部电极激活电路320的RF发生器可以包括返回垫电极330，所述返回垫电极330被配置用于舒适地接合患者的背或在肾附近的身体其他部分。由RF发生器产生的射频能量通过置于导管的轴104的内腔中的导体装置110与在导管101的远侧端处的治疗元件101耦合。
使用图8所示的设备的肾去神经支配治疗通常使用定位在肾动脉内的治疗元件101的一个或多个电极组119和定位在患者的背上的返回垫电极330来执行，其中RF发生器在单极模式下操作。在这种实现中，所述一个或多个电极组119的电极120被配置用于以单极配置的操作。在其他实现中，所述一个或多个电极组119的电极120能够被配置用于以双极配置的操作，在这种情况下不需要返回电极垫330。
射频能量依照预定激活顺序流过一个或多个电极组119，在肾动脉的邻近组织中引起电流流动和焦耳热加热。电极120的顺序激活被用于产生如在上文中所描述的重叠的加热区，其中每个加热区都包括在与治疗元件相距一定距离的位置具有足以消融血管周肾神经的大体上连续的欧姆加热的远侧区，以及在贴近治疗元件101的位置具有不足以对邻近治疗元件101的肾动脉组织造成热损伤的间歇欧姆加热的近侧区。
一般而言，当肾动脉组织温度上升为高于大约113℉(50℃)时，蛋白质被永久性地破坏(包括肾神经纤维的蛋白质)。如果加热为超过大约65℃，则胶原质变性并且组织萎缩。如果加热为超过大约65℃并且高达100℃，则细胞壁破裂并且油与水分离。高于大约100℃，则组织脱水。
根据一些实施例，电极激活电路320被配置用于依照预定顺序并且响应于从温度测量电路328接收的信号来控制一个或多个电极组119的电极120的激活和去激活。电极激活电路320控制输送到电极120的射频能量，以便将远侧加热区内的电流密度维持在足以使靶组织加热到至少65℃的温度的水平并且将近侧加热区内的电流密度维持在不足以使邻近治疗元件的组织加热到高于50℃的温度的水平。
位于治疗元件101处的温度传感器123提供肾动脉组织温度的连续监测，并且RF发生器功率被自动调整使得目标温度被实现和维持。阻抗传感器装置326可以被用于在RF去神经支配治疗期间测量和监测电阻抗，并且可以基于阻抗测量或阻抗和温度测量的组合来调节RF发生器320的功率和定时。消融区域的尺寸主要由在治疗元件101处的电极123的尺寸、数量和形状、所施加的功率以及施加能量的时间的持续时间来确定。
标志带314能够被放置在治疗元件101的一个或多个部分上以在过程期间实现可视化。诸如轴104的一个或多个部分(例如在铰接机构356处)的导管101的其他部分可以包括标志带314。标志带314可以例如是铂或其他不透射线的金属的实心的或分裂的带。不透射线的材料被理解为是能够在医疗过程期间在荧光屏幕或另一成像技术上产生相对亮的图像的材料。这个相对亮的图像帮助用户确定导管100的特定部分，举例来说诸如为导管101的尖端、治疗元件101以及铰接机构356。根据一些实施例，导管100的编织物和/或电极能够是不透射线的，并且如果充气囊被用作可扩展结构103的一部分，则充气囊可以被填充以对照物/盐水。
在本文中所公开的各种实施例在用于对高血压的控制的血管周肾神经消融的背景下一般地被描述。但应理解的是，本公开内容的实施例在其他背景下也具有适用性，诸如从身体的其他脉管及身体的其他组织内部执行消融，其中所述其他脉管包括其他动脉、静脉以及脉管系统(例如心脏和泌尿脉管系统和脉管，而所述其他组织包括各种器官。
应理解的是，即使已在前述说明中连同各种实施例的结构和功能的细节一起阐述了各种实施例的许多特征，但这种详细说明也仅是示意性的，并且可以在由所附权利要求用其表示的术语的广泛的一般意义所指示的最大可能的范围内，在细节上，特别是在由各种实施例所示意的部分的结构和布置方面进行改变。

Claims (15)

1. 一种设备，其包括：
导管，其包括具有近侧端和远侧端的柔性轴；
治疗元件，其被设置在所述轴的远侧端处；
定位装置，其被设置在所述轴的远侧端处并且被配置用于在消融期间维持所述治疗元件相对于在治疗部位处的靶组织的定位；
多个电极，其限定电极组并且相对于彼此被布置在所述治疗元件处，所述电极组被配置用于按预定顺序可交换的激活和去激活，以产生对准所述靶组织的多个重叠的加热区；
所述加热区重叠以限定在与所述治疗元件相距一定距离的位置与足以消融所述靶组织的高热量产生关联的远侧区和与比所述远侧区的热量产生低的对在邻近所述治疗元件的所述治疗部位处的组织不造成热损伤或造成可忽略的热损伤的低热量产生关联的近侧区；以及
电导体装置，其沿所述轴延伸并且与所述电极组耦合。
2. 根据权利要求1所述的设备，其中：
所述远测区与大体上连续的欧姆加热关联；以及
所述近侧区与间歇的欧姆加热关联。
3. 根据权利要求1所述的设备，其中所述近侧区具有比所述远侧区少的重叠电流路径。
4. 根据权利要求1所述的设备，其中所述多个加热区中的至少一些基于所述电极组的激活和去激活在所述治疗元件处具有空间上分开的起端。
5. 根据权利要求1所述的设备，其中所述近侧区内的加热低于造成在邻近所述治疗元件的所述治疗部位处的组织的凝固性坏死所需的温度。
6. 根据权利要求1所述的设备，其中所述近侧区内的加热不足以使邻近所述治疗元件的组织的温度升高至高于大约50℃。
7. 根据权利要求1所述的设备，其中限定所述电极组的所述多个电极按环形图案或螺旋形图案布置。
8. 根据权利要求1所述的设备，其中所述治疗元件包括冷却装置，所述冷却装置被配置用于在限定在所述治疗元件与邻近所述治疗元件的组织之间的电极-组织界面处提供冷却。
9. 根据权利要求1所述的设备，其中所述定位装置包括充气囊或可扩展网格结构。
10. 根据权利要求1所述的设备，其中所述治疗装置和所述定位装置被并置在公共结构上。
11. 根据权利要求1所述的设备，其中：
所述治疗元件和所述定位装置针对在肾动脉内的部署来定尺寸；并且
所述靶组织包括在所述肾动脉处或邻近所述肾动脉的血管周肾神经组织。
12. 根据权利要求1所述的设备，其中所述治疗元件被配置用于治疗器官、脉管、肿瘤或患病组织的靶组织。
13. 根据权利要求1所述的设备，其中所述治疗元件被配置用于肺静脉消融。
14. 根据前述权利要求中任一项所述的设备，其包括设置在所述治疗元件处并且与所述电导体装置耦合的温度传感器装置，所述温度传感器装置被配置用于感测所述电极组中的至少一些电极的温度。
15. 根据权利要求14所述的设备，其包括与所述电导体装置耦合的高频AC发生器，其中所述发生器被配置用于依照预定顺序并且响应于从所述温度传感器装置接收的信号来控制所述电极的激活和去激活，所述发生器控制向所述电极的高频AC能量输送，以便在所述远侧区内产生足以使所述靶组织加热到至少大约55℃的温度的热量并且将所述近侧区内的加热限制到对邻近所述治疗元件的组织不造成热损伤或造成可忽略的热损伤的温度。
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