CN105228546A - 利用阻抗补偿的用于治疗高血压的医疗器械和方法 - Google Patents

利用阻抗补偿的用于治疗高血压的医疗器械和方法 Download PDF

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CN105228546A
CN105228546A CN201480028576.7A CN201480028576A CN105228546A CN 105228546 A CN105228546 A CN 105228546A CN 201480028576 A CN201480028576 A CN 201480028576A CN 105228546 A CN105228546 A CN 105228546A
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CN105228546B (zh
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普拉波德·马瑟
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Boston Scientific Scimed Inc
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Abstract

披露了用于确定漏电估算值确定的控制单元、医疗装置以及方法。医疗装置包括确定在体内医疗器械的第一电极片(5050)和第二电极片(5070)之间漏电估算值的控制单元。所述第一电极片具有有源电极和间隔的接地电极。所述第二电极片具有有源电极和接地电极。所述第一电极片的所述接地电极被电连接至所述第二电极片的所述接地电极。

Description

利用阻抗补偿的用于治疗高血压的医疗器械和方法
相关申请的交叉引用
本申请根据U.S.C.35§119要求于2013年3月15日提交的序列号为61/788，429的美国临时申请的优先权，其整个内容以引用方式并入本文。
技术领域
本发明关于医疗器械以及用于制造医疗器械的方法。更特别地，本发明关于用于治疗高血压的医疗器械和方法。
背景技术
已开发出各种各样的体内医疗器械以用于医疗用途，如在血管内使用。这些器械中的一些包括导丝、导管等。这些器械是通过各种不同的制造方法中的任何一种进行制造并可根据各种方法中的任何一种进行使用。在已知的医疗器械和方法中，各自具有某些优点和缺点。持续地需要提供替代的医疗器械以及用于制造和使用医疗器械的替代方法。
发明内容
本发明公开了医疗器械和用于制造和使用其的方法。
本发明公开了一种用于确定在体内医疗器械的第一电极片和第二电极片之间漏电的控制单元。第一电极片可与第二电极片相间隔。第一电极片可具有有源电极和间隔的接地电极。第二电极片可具有有源电极和接地电极。第一电极片的接地电极可被电连接至第二电极片的接地电极。控制单元可包括用于将控制单元电连接至体内医疗器械的输入/输出块和通信地耦合至输入/输出块的控制器。控制器可被编程为经输入/输出块将第一信号施加至体内医疗器械的第一电极片的有源电极，且作为响应，确定与位于第一电极片的有源电极和第一电极片的接地电极之间的阻抗相关的度量。控制器还可被编程为经输入/输出块将第二信号施加至体内医疗器械的第二电极片的有源电极，且作为响应，确定与位于第二电极片的有源电极和第二电极片的接地电极之间的阻抗相关的度量。此外，控制器可被编程为使用与位于第二电极片的有源电极和第二电极片的接地电极之间的阻抗相关的度量确定在第一电极片的有源电极和第二电极片的接地电极之间的漏电的估计值。
本发明还公开了一种用于确定在体内医疗器械的第一电极片和第二电极片之间漏电的方法，其中第一电极片与第二电极片相间隔，且其中第一电极片具有有源电极和间隔的接地电极，且第二电极片具有有源电极和接地电极，其中第一电极片的接地电极被电连接至第二电极片的接地电极。该方法可包括将第一信号施加至体内医疗器械的第一电极片的有源电极，且作为响应，确定与位于第一电极片的有源电极和第一电极片的接地电极之间的阻抗相关的度量。该方法还可包括将第二信号施加至体内医疗器械的第二电极片的有源电极，且作为响应，确定与位于第二电极片的有源电极和第二电极片的接地电极之间的阻抗相关的度量。此外，该方法可包括使用与位于第二电极片的有源电极和第二电极片的接地电极之间的阻抗相关的度量确定在第一电极片的有源电极和第二电极片的接地电极之间的漏电的估计值。此外，该方法可包括基于在第一电极片的有源电极和第二电极片的接地电极之间的漏电的估计值补偿与位于第一电极片的有源电极和第一电极片的接地电极之间的阻抗相关的度量。
本发明还公开了一种系统，其可包括具有第一电极片和第二电极片的体内医疗器械。第一电极片可与第二电极片相间隔。第一电极片可具有有源电极和间隔的接地电极。第二电极片可具有有源电极和接地电极。第一电极片的接地电极可被电连接至第二电极片的接地电极。控制单元可被耦合至体内医疗器械。控制单元可被编程为将第一信号施加至体内医疗器械的第一电极片的有源电极，且作为响应，确定与位于第一电极片的有源电极和第一电极片的接地电极之间的阻抗相关的度量。控制单元还可被编程为将第二信号施加至体内医疗器械的第二电极片的有源电极，且作为响应，确定与位于第二电极片的有源电极和第二电极片的接地电极之间的阻抗相关的度量。控制单元还可被编程为使用与位于第二电极片的有源电极和第二电极片的接地电极之间的阻抗相关的度量确定在第一电极片的有源电极和第二电极片的接地电极之间的漏电的估计值以及基于在第一电极片的有源电极和第二电极片的接地电极之间的漏电的估计值补偿与位于第一电极片的有源电极和第一电极片的接地电极之间的阻抗相关的度量。
本发明还公开了一种用于测量一种物质的一部分的阻抗的方法。该方法可包括促使电极组件的至少一部分与该物质相接触。电极组件可包括第一对双极电极，其包括第一有源电极和第一接地电极；以及第二对双极电极，其包括第二有源电极和第二接地电极。第一和第二接地电极可具有共用的接地。该方法还可包括测量在第一有源电极和接地之间的阻抗以确定第一测量的阻抗。第一测量的阻抗可包括位于第一有源电极和第一接地电极之间的目标阻抗以及在第一有源电极和第二接地电极之间的漏阻抗。目标阻抗和漏阻抗可根据方程相关联：
(1/M1)＝(1/Z1)+(1/Z12)
其中，M1为第一测量的阻抗，Z1为目标阻抗且Z12为漏阻抗。
该方法还可包括测量在第二有源电极和接地之间的阻抗以确定第二测量的阻抗。漏阻抗可基本上等于一个常数乘以第二测量的阻抗。该方法还可包括使用第一测量的阻抗和第二测量的阻抗计算目标阻抗。
另一个用于补偿阻抗测量的实例方法可包括提供电极组件，其包括具有第一对双极电极的第一电极片、具有第二对双极电极的第二电极片和被耦合至第一电极片和第二电极片的共用的接地。该方法还可包括用第一电极片测量阻抗以确定第一测量的阻抗。第一测量的阻抗可包括目标阻抗和漏阻抗。目标阻抗和漏阻抗可根据公式相关联：
(1/M1)＝(1/Z1)+(1/Z12)
其中，M1为第一测量的阻抗，Z1为目标阻抗且Z12为漏阻抗；
该方法还可包括用第二电极片测量阻抗以确定第二测量的阻抗。漏阻抗可基本上等于一个常数乘以第二测量的阻抗。该方法还可包括使用第一测量的阻抗和第二测量的阻抗计算目标阻抗。
上面有关一些实施例的概述并不旨在描述本发明的每个所公开的实施例或每个实施方式。下面的附图及具体实施方式更具体地举例说明了这些实施例。
附图说明
图1A示出用于重建组织的实例系统的简化示意图。
图1B为导管的实例可扩张装置的立体图。
图1C为图1B所示的可扩张装置在展开形态中的俯视图。
图1D和1E为实例可扩张装置的立体图。
图1F为实例可扩张装置的立体图。
图2A为实例电极组件的俯视图。
图2B为图2A的局部截面视图A-A。
图2C为图2A的局部截面视图B-B。
图3A-3D为具有多个电极片的各种实例电极组件的俯视图。
图4A-4C为具有单个远端电极片的各种实例电极组件的俯视图。
图5A-5F为具有单个近端电极片的各种实例电极组件的俯视图。
图5G-I为各种实例单极电极组件的俯视图。
图6为用于重建身体通路的图1A所述系统的横截面视图。
图7-10示出温度曲线的各种非限制性实例。
图11和12示出通过比较温度曲线的某些非限制性实例得到的实验结果。
图13和14示出控制回路的一个实施例。
图13A示出控制回路的另一个实施例。
图15示出用于电极的温度随时间变化的一个非限制性实例。
图16-23示出在治疗期间与八个电极相关联的各种属性的一个非限制性实例。
图24A-24F为来自治疗的一个实施例的实例截屏。
图25-30示出评估用于肾脏去神经术的效力和安全性的一个实验。
图31和32示意性地示出与两个电极相关联的实例治疗区。
图33示出包括位于身体通路中的电极阵列的可扩张球囊。
图34-38示出除了其他以外评估通过电外科手术在紧邻肾动脉的组织中创建的治疗区的范围的实验。
图39-41示出在RF治疗期间使治疗区重叠的一个实例。
图42和43示意性地示出包括用于刺激和测量神经信号的电极的导管的可扩张装置。
图44和45示意性地示出在治疗前和在接收至少一些治疗后的神经反应信号。
图46示出可扩张球囊的一个实施例。
图47-50B示出肾脏去神经治疗的方法的实施例。
图51为实例医疗器械的一部分的示意图。
图52为实例医疗器械的一部分的示意图。
图53为实例控制单元的示意图。
具体实施方式
对于下面定义的术语而言，这些定义应是适用的，除非在权利要求中或本说明书的其他地方给出了不同的定义。
在本文中，不论是否明确指出，所有数值都被假定为可用术语“大约”进行修饰。术语“大约”通常是指本领域的技术人员将认为等同于所引用的值的一个范围内的值(即，具有相同功能或结果)。在许多情况下，术语“大约”可包括被四舍五入至最近的有效数字的数值。
经端点表述的数值范围包括在该范围中的所有数字(例如，1至5包括1、1.5、2、2.75、3、3.80、4和5)。
如在本说明书和所附权利要求中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，除非内容另外明确指出外。如在本说明书和所附权利要求中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。
要注意的是在本说明书中对“一个实施例”、“一些实施例”、“其他实施例”等的参照表示所描述的实施例可能包括一个或多个特定的特性、结构和/或特征。然而，这种叙述不一定表示所有实施例均包括特定的特性、结构和/或特征。此外，当结合一个实施例描述特定的特性、结构和/或特征时，应理解的是不论是否明确地进行描述，这种特性、结构和/或特征也可与其他实施例结合使用，除非明确地说明与此相反以外。
应参照附图阅读下面的详细描述，其中在不同的附图中相似的元件具有相同的编号。不一定是按比例绘制的附图描述了说明性实施例且不旨在限制本发明的范围。
医师使用导管来进入身体内部组织并通过改变身体内部组织，特别是在体腔(诸如血管)内或周围的身体组织，而影响治疗。例如，球囊血管成形术和其他导管通常用于打开已因动脉粥样硬化性疾病而变窄的动脉。
导管用于在患有难治性高血压的患者体内通过RF能量治疗进行肾脏去神经术(renaldenervation)。这是一个较新的程序，已发现其在治疗高血压的方面为临床有效的。在该程序中，将RF能量施加于肾动脉壁上以减少邻近肾动脉的交感神经系统的过度活化(其通常为慢性高血压的原因)。已发现该程序在一些情况下是成功的，但也与明显的疼痛相关联，且现有的治疗对于医师来说既较难精确地进行也相当耗时。
另一个影响许多患者的情况为充血性心脏衰竭(“CHF”)。CHF是当心脏受损且至身体器官的血流减少时所发生的情况。如果血流充分减少，肾功能则为之改变，这产生了流体潴留、异常的激素分泌和血管收缩增加。这些结果增加了心脏的工作负担并进一步地降低了心脏通过肾脏和循环系统泵送血液的能力。
据认为，肾脏逐渐减小的灌注是使CHF的恶性循环长存的主要的非心脏的原因。例如，随着心脏努力地泵送血液，保持或减少了心输出量且肾脏保存了流体和电解质来保持心脏的心搏量。所产生的压力增加进一步地使心肌超载，从而使心肌必须更努力地工作以对抗更高的压力进行泵送。随后，已经受损的心肌进一步地通过所增加的压力而受压和受损。除了加剧心脏衰竭外，肾衰竭会导致恶性循环并进一步地恶化肾功能。例如，在上述的前向流动性(forwardflow)心脏衰竭(收缩性心力衰竭)中，肾脏变得缺血。在后向性(backward)心脏衰竭(舒张性心力衰竭)中，与肾静脉高血压相比，肾脏变得充血。因此，肾脏会使其自身的衰竭恶化。
肾脏的功能可归为三大类：过滤血液并排泄通过身体的新陈代谢所生成的废物；调节盐、水、电解质及酸碱平衡；并分泌激素来保持生命器官的血流。在不具有正常运转的肾脏的情况下，患者将经受水潴留、减少的尿流和在血液和身体内废物毒素的累积。这些情况是由减少的肾脏功能或肾脏衰竭(肾衰竭)所导致的且认为是会增加心脏的工作负担。在CHF患者体内，随着由于不正常运转的肾脏而使流体潴留并导致血液毒素的累积，肾衰竭将使心脏进一步恶化。所导致的高血压也对脑血管疾病和中风的发展具有引人注目的影响。
自主神经系统是以可变程度影响几乎每个器官和生理系统的神经网络。大体上，该系统是由交感神经和副交感神经所组成的。例如，至肾脏的交感神经沿脊柱和神经链的神经节内或腹腔神经节内的和突触横穿交感神经链，然后继续经在“肾神经”内的节后纤维使肾脏受神经支配。在肾神经内，沿肾门(动脉且在一定程度上为静脉)行进的是节后交感神经和源于肾脏的传入神经。源于肾脏的传入神经在后根内行进(如果其为疼痛纤维)并进入前根，如果其为感觉纤维，则随后进入脊髓并最终进入大脑的专门区域。传入神经、压力感受器和化学感受器将信息从肾脏经大脑传递回交感神经系统；其消融或抑制至少部分地是造成肾神经消融或去神经或部分中断后血压改善的原因。已提出并部分地经实验证明压力感受器在颈动脉窦水平下的响应是通过肾动脉的传入神经所调节的，从而使肾动脉传入神经响应的损失减弱劲动脉的压力感受器的响应以造成动脉血压中的变化(AmericanJ.PhysiologyandRenalPhysiology279:F491-F501，2000，其公开内容通过引用并入本文)。
在动物模型中已确定心脏衰竭情况导致肾脏的异常高的交感神经激活。在肾交感神经活动力的增加导致从身体所移除的水和钠减少，以及增加的肾素分泌，其刺激从肾上腺进行的醛固酮分泌。肾素分泌的增加会导致血管紧缩素II水平的增加，其导致供给肾脏的血管收缩以及全身的血管收缩，所有这些均导致肾血流量的降低和高血压。交感肾神经活动力的降低，例如，经去神经支配而实现的，可使这些过程反转且事实上已在临床上进行了证明。
由于患者高血压，交感神经的超速传动促成CHF的发展和进展。与那些具有原发性高血压的那些相比，从肾脏和心脏外溢至静脉血浆的去甲肾上腺素比CHF患者中的水平更高。慢性交感神经刺激使心脏过度工作，这直接地是由于心脏增加了其输出，且间接地是由于收缩的脉管系统表现出心脏需对抗其进行泵送的较高的阻力。随着心脏张紧以泵送更多的血液，左心室的质量增加且发生心脏重塑。心脏重塑导致心脏的异质性交感神经激活，其进一步地破坏心脏收缩的同步性。因此，重塑最初有助于增加心脏的泵送，但最终减少了心脏的效率。左心室功能的降低进一步激活了交感神经系统以及肾素-血管紧缩素-醛固酮系统，这促使了从高血压至CHF的恶性循环。
本发明的实施例涉及通常用于治疗靶组织的功率生成和控制器械，从而实现治疗效果。在一些实施例中，靶组织是含有或紧邻神经的组织，其包括肾动脉和相关联的肾神经。在其他实施例中，靶组织是内腔组织，其还进一步地包括患病组织，如在动脉疾病中所发现的。
在本发明的另一个示例性实施例中，以目标剂量输送能量的能力可被用于神经组织，从而实现有益的生物反应。例如，已知慢性疼痛、泌尿功能障碍、高血压和各种各样的其他持续病症已知会通过神经组织的操作受到影响。例如，已知可能对药物没有反应的慢性高血压可通过停止紧邻肾动脉的过度的神经活动来改善或消除。也已知神经组织并不天然地拥有再生特征。因此，可通过使神经组织的传导路径断裂而有利地影响过度的神经活动。当使神经传导路径断裂时，特别有利的是避免损害邻近的神经或器官组织。用于指导和控制能量剂量的能力非常适合于神经组织的治疗。无论是在加热还是在消融能量剂量时，如本文所描述和公开的精确控制能量的输送可被引导至神经组织。此外，能量的定向施加可足以靶准神经而无需与其实现精确接触，如当使用典型的消融探针时所需要的。例如，可在足够高的能使神经组织变性的温度下施加偏心加热，而不会导致消融并且无需穿透内腔组织。然而，将本发明的能量输送表面配置成穿透组织并以类似于消融探针的方式输送消融能量也是可取的，其中通过电力控制和发电器械控制精确的能量剂量。
在一些实施例中，去神经治疗的效力可通过在治疗之前、期间和/或之后进行测量的方式进行评估，从而使治疗的一个或多个参数适合于特定的患者或识别进行额外的治疗的需要。例如，去神经系统可包括用于评估治疗是否已引起或正在引起在靶或紧邻组织中的神经活动力的降低的功能，其可能提供用于调整治疗参数或指出进行额外的治疗的必要性的反馈。
虽然本发明集中于在脉管系统中使用该技术，但该技术也将有益于其他内腔组织。可使用本发明的其他解剖结构为食道、口腔、鼻咽腔、咽鼓管和鼓室、大脑的窦、动脉系统、静脉系统、心脏、喉、气管、支气管、胃、十二指肠、回肠、结肠、直肠、膀胱、输尿管、射精管、输精管、尿道、子宫腔、阴道腔和子宫颈管。
系统概述
图1A示出用于在身体通道内进行治疗的系统100。系统100包括控制单元110。控制单元110可包括用于将RF能量输送至导管装置120的RF发生器。在共同转让的美国专利申请公开号US2012/0095461中公开了可与本文所公开的实施例一起使用的示例性控制单元和相关联的能量输送方法，该专利通过引用并入本文。在共同转让的专利号为7,742,795且题为“用于动脉粥样硬化和其他靶组织和/或结构的选择性治疗的调谐RF能量”的美国专利号为7,291,146且题为“动脉粥样硬化材料的可选的偏心重建和/或消融”的美国专利以及公开号为2008/0188912且题为“用于在身体组织上诱导所需的温度效应的系统”的美国专利，其全部的公开内容均以引用并入本文。在一些实施例中，特别是在一些利用单极能量输送的实施例中，系统还可包括可与导管装置关联的接地/共用电极，电性联接至控制单元110的单独极板，或者或以其他方式与系统100相关联。
在一些实施例中，控制单元110可包括处理器或以其他方式被联接至处理器以控制或记录治疗。典型地，处理器将包括计算机硬件和/或软件，其常包括一个或多个可编程处理器单元，运行用于实施本文所述的实施例和方法中的一个或多个中的一些或所有的机器可读程序指令或代码。代码通常将体现在有形介质中，如存储器(可选地为只读存储器、随机存取存储器、非易失性存储器等)和/或记录介质(如软盘、硬盘驱动器、CD、DVD、非易失性固态存储卡等)。也可经网络连接(如无线网络、以太网、因特网、内联网等)将代码和/或相关联的数据和信号传输至处理器或从处理器传输，代码中的一些或全部也可经由一个或多个总线在导管系统的组件之间并在处理器内进行传输，且在处理器中将通常包括合适的标准或专有的通信卡、连接器、电缆等。处理器通常可被配置成至少部分地通过用软件代码对处理器进行编程而进行本文所描述的计算和信号传输步骤，软件代码可被写成单个程序、一系列的单独子程序或相关的程序等。处理器可包括标准或专有的数字和/或模拟信号处理硬件、软件和/或固件且可能需要具有足够的处理能力以在治疗患者的期间进行本文所述的计算，可选地，处理器包括个人计算机、笔记本计算机、平板计算机、专有处理单元或其组合。也可包括与现代计算机系统相关联的标准或专有输入装置(如鼠标、键盘、触摸屏、操纵杆等)和输出装置(如打印机、扬声器、显示器等)，在大范围的集中式或分布式数据处理架构中可采用具有多个处理单元(甚或单独的计算机)的处理器。
在一些实施例中，用于系统100的控制软件可使用客户端-服务器方案以进一步地加强系统的易用性、灵活性和可靠性。“客户端”为系统的控制逻辑；“服务器”为控制硬件。通信管理器将系统状况中的变化输送至订阅客户端和服务器。客户端基于特定的情况变化“知道”当前的系统情况是什么以及要进行的命令或决定是什么。服务器基于客户端的命令执行系统的功能。由于通信管理器为集中式信息管理器，新的系统硬件可能不需要改变现有的客户端-服务器的关系；新的系统硬件和其相关的控制逻辑可能随后仅变成了对于通过通信管理器管理的信息的额外的“订阅者”。该控制方案可提供具有固定的基础例行程序的稳健的中央操作程序的益处；为了操作被设计成与系统一起操作的新电路部件，可能无需改变基础例行程序。
可扩张装置和电极组件
返回至图1A，导管装置120可包括可扩张装置130，其可以是顺应性、非顺应性或半顺应性球囊。可扩张装置130包括多个电性联接至控制单元110的多个电极组件。这种电极组件可被电配置成单极或双极，且进一步地具有热感测能力。
如在图1B中所示，根据多个圆筒形治疗区A-D，电极组件可被布置在可扩张装置130上，在此处所示的是在扩张状态中。在其他实施例中，其中的一些在下面进一步地进行描述，可扩张装置130或治疗系统的其他部件可包括不在治疗区中的或以其他方式未使用或被配置成输送治疗能量的额外的电极组件。
在图1C中进一步地示出了治疗区A-D和相关联的电极组件140a-d，其为图1B所示的可扩张装置130的“展开”描述。在一些实施例中，可扩张装置为直径为4mm的球囊和两个电极组件140a-b。在其他实施例中，可扩张装置为具有5mm直径和三个电极组件140a-c的球囊。在一些实施例中，可扩张装置为具有6、7或8mm直径和四个电极组件140a-d的球囊，如在图1B中所示。在图1D中示出了具有两个电极组件140a、b的4mm球囊并在图1E中示出了具有三个电极组件140a-c的5mm球囊。对于这些构造中的任何一个，可扩张装置可具有约10mm至约100mm或约18mm至约25mm的工作长度，这是在图1B和1C中所示的所有治疗区A-D的近似的纵向跨距。电极组件140a-d可使用粘合剂被附接至球囊。
图1F示意性地示出包括单极电极190阵列的可扩张装置(然而，在图1B至1E和其他图中所示的电极阵列也可用于单极构造中)。在一些情况下，在可扩张装置上的单极电极190中的一个可被配置成充当用于其他电极的共用或接地电极。可替代地，扩张装置上的单独或具有不同形状和配置的电极(如在图1F中以虚线示出的环形电极192)或其他可扩张装置上的电极(如图1G中的194)或以其他方式与导管相关联的电极可被配置成共用电极。在其他的情况下，接地片可被固定至患者的皮肤以用作共用电极。尽管未在图1G中明确地示出，与本文所述的其他实施例相类似地，单极电极中的每一个可定位于紧邻温度传感装置或位于温度传感装置上。
a.重叠和非重叠治疗区
返回图1B，治疗区A-D彼此沿纵轴线L-L为纵向相邻，且可进行配置以使通过电极组件所施加的能量产生不重叠的治疗。通过纵向相邻的双极电极组件140a-d所施加的治疗为沿纵轴线L-L的周向非连续的。例如，参照图1C，在治疗区A中所产生的毁损灶可能在一些实施例中与在治疗区B中所产生的毁损灶绕圆周(在该视图中为关于L-L成横向地)的重叠最小化。
然而，在其他的实施例中，通过电极组件，如图1C中所示的电极组件所施加的能量可能沿纵向、沿圆周和/或以其他方式在至少一定程度上发生重叠。图31和32示意性地示出如何向电极3102和3104通电以形成重叠治疗区的非限制性实例。尽管未在图31和32中明确示出，电极3102和3104中的每一个可以是双极电极对(或可以是单个单极电极)且可位于导管球囊或其他可扩张装置的外表面上，从而使其沿纵向和沿圆周而彼此偏移(例如，如在图1C中所示)。如在图31中所示，电极3102和3104中的每一个可与治疗区相关联(或可被配置成在与电极对合的组织中产生这样的治疗区)，该治疗区包括目标温度区(其外边界被标为“TT”)以及热羽流区(其外边界被标为“TP”)。在一些实施例中，目标温度区代表处于或高于期望目标治疗温度或在期望目标温度范围内的组织区域。在一些实施例中，热羽流区代表不一定处于目标温度或在目标温度范围内，但相对于热羽流区外的未经治疗区呈现出温度升高的组织区域。
在电极/电极对之间的治疗区是否将重叠可能会受到各种因素的影响，包括但不限于电极几何形状、电极的布置密度、电极定位、(多个)接地/共用电极的布置和几何形状(在单极实施例中)、能量发生器的输出设置、输出电压、输出功率、占空比、输出频率、组织特征、组织类型等的影响。
在一些实施例中，双极电极对的单个电极可限定其自身的治疗区，且这种治疗区可部分或完全地重叠。
在图31中，治疗区的热羽流区发生重叠，然而目标温度区不重叠。在图32中，目标温度区和热羽流区都发生重叠。在一些实施例中，治疗区的重叠可大致绕装置的圆周和/或绕身体通道周围组织的圆周连续地延伸。在其他实施例中，在治疗区中可能会发生重叠，然而，重叠将不会绕周面为大致连续的且在治疗区中可能存在有明显的间断。
已通过实验确定至少一些利用球囊安装电极的电外科系统可在相邻的电极片之间产生重叠的治疗区，且在至少一些情况下，产生绕身体通道圆周的有效地大致连续的治疗区。在一个实验中，使用类似于在美国公开号2008/0188912(其全部内容通过引用并入本文)中所示和所述的，特别是在图9C(此处以图33进行重现)中所示的导管和可扩张球囊在相邻的电极对之间生成重叠的治疗区，从而使治疗区绕圆周以大致连续的方式有效延伸。如在图33中所示，可扩张球囊20包括围绕球囊周面定位的多个沿纵向延伸的系列双极电极对34。与例如在图1C中所示的电极阵列不同，在图33中所示的电极阵列对称地布置在可扩张球囊20上。
在使用类似于图33中所示的基于导管的球囊电极阵列的实验中，在第28±1天和第84天评估用各种功率进行治疗的且在射频疗法期间(约60℃至约75℃进行约5秒至约120秒)或未经治疗的14个肾血管的局部反应。此外，经光学显微镜评估来自总共7个动物的肾脏。
肾脏和肾动脉是与下方肌肉一起无损地移植且被固定在10％中性缓冲的福尔马林中。接着，提交所固定的组织进行组织病理学处理和评估。各个脉管以约每3-4mm进行修整直到组织被耗尽、进行处理、嵌入石蜡中、以～5微米进行两次切片以及用苏木精和曙红(H+E)和弹力蛋白三色(ET)进行染色。肾脏则按三个水平(前端、中心和尾部)进行修整、进行处理、嵌入石蜡中、切片并用H+E进行染色。经光学显微镜检查所产生的所有载玻片。
对用各种功率进行治疗的且在射频治疗期间或未经治疗的六个急性动脉的逐层切片的评估和对依赖的肾脏的评估示出特征为介质和血管周组织中的凝固性坏死和胶原透明样变化的急性热变化。图34示出以六对电极在75℃方案下治疗十秒钟的左肾动脉(被标为A)和周围组织的横截面。在图34中，周向的热损伤在虚线的界限内被观测到，其包括对若干神经分支(如箭头所示)、神经节(短箭头)和相邻淋巴结(LN)的一部分的损伤。图35示出以六对电极在75℃方案下治疗五秒钟的右肾动脉和周围组织的横截面。在图35中，在虚线的界限内观测到周向损伤，其包括若干神经分支(如箭头所示)。参照图34和35，热损伤在左动脉治疗的最中间节段中并在右动脉的介质中是沿周向的。肾脏未显示有与治疗相关的变化。周向治疗对于在深度高达10mm的径向范围的外在肾神经支配中实现和产生损伤是有效的。这使得大小可能引起显著的再狭窄反应的球囊治疗所引起的显著程序性损伤最小化。
图36和37示出图34的左肾动脉在治疗后的第27天的额外的横截面。图38为在75℃进行的RF治疗的另一个代表性的低放大率图像。在图38中的治疗区是通过残余的坏死中膜和外膜因早平滑肌细胞增生、纤维增生和炎性浸润(例如，支架)增厚而显示出的。图38还示出治疗区延伸至相邻的外膜中(如以虚线所示)。
图39-41进一步地示出在一些实施例中治疗区是如何在RF能量治疗期间发生重叠的。图39-41示出在三十秒治疗期间位于填充有热敏感凝胶的圆筒中的VessixV2导管。图39示出在治疗刚开始后的热敏感凝胶，其中凝胶中的正方形斑块显示局部电极加热。如在图40中所示，随着治疗的进展，凝胶中的斑块由于热传导大小增加并相互接近以触及彼此。图41示出在完成30秒治疗时的凝胶，其示出在斑块的大致重叠。
b.电极组件结构
返回图1C，每个电极片组件包括4个主要元件，其为远端电极片150a-d、中间尾部160a-d、近端电极片170a-d、近端尾部180b、d(未示出用于电极片组件140b和140c的近端尾部)。参照图2A-C示出并描述了电极组件140a-d的结构详情。
图2A示出电极组件200的俯视图，其在图1C中被识别为电极组件140。电极组件200被构造为具有多层的柔性电路。这种层可以是连续的或不连续的，即由离散部分所组成。如在图2B和2C中所示，绝缘的基层202为电极组件200提供了基础。基层202可由柔性聚合物，如聚酰亚胺构造而成。在一些实施例中，基层202的厚度大约为0.5mil(0.0127mm)。由多个离散迹线构成的传导层204层叠在基层202的顶部上。例如，传导层204可以是电沉积铜层。在一些实施例中，传导层204的厚度大约为0.018mm。绝缘层206离散地或连续地层叠在传导层204的顶部上，从而传导层204在基层202和绝缘层206之间被流体密封。类似于基层202，绝缘层206可由柔性聚合物，如聚酰亚胺构造而成。在一些实施例中，绝缘层206的厚度大约为0.5mil(0.0127mm)。在其他实施例中，绝缘层206为完全或部分的聚合物涂层，如PTFE或硅酮。
在图2A中示出的电极组件200包括远端电极片208。在该区域中，基层202形成矩形形状。如图所示，电极组件200可包括多个开口以提供额外的柔性且片和组件的其他部分可包括圆形或弯曲的转角、过渡部和其他部分。在一些情况下，开口和圆形/弯曲的特性可加强组件对从可扩张装置进行分层的阻力，如在一些情况下，当可扩张装置重复扩张和塌缩(其也可能是从保护护套进行的布置和取回至保护护套中)时所可能发生的，如在手术过程中治疗多个部位时所需要的。
远侧电极片208包括多个层叠在基层202顶部上的离散迹线。迹线包括接地迹线210、有源电极迹线212和传感器迹线214。接地迹线210包括横向地偏离传感器接地片218的细长电极支撑件216。传感器接地片218被电联接至接地迹线210的细长支撑件216并位于远端电极片208的中心处。桥接部220将传感器接地片218的最远端部分连接至接地迹线210的细长电极支撑件216的远端部分。随着行进至传感器接地片218，桥接部220在宽度上逐渐变细。在一些实施例中，桥接部220具有相对均匀且薄的宽度以获得所需量的柔性。细长的电极支撑件216在其近端处的宽度逐渐变细，然而，这不是必需的。在一些实施例中，细长的电极支撑件216可在其近端部分突然地过渡至薄得多的迹线以实现所需量的柔性。通常，在示出缩颈处的迹线的曲率优化以减少球囊再捕获力以及减少任何钩住可能存在的更锐利轮廓的可能性。迹线的形状和位置也可优化以向作为整体的电极组件200提供尺寸稳定性，从而在布置和使用期间避免变形。
图2A的接地迹线210和有源电极迹线212共享类似的构造。有源电极迹线212还包括细长的电极支撑件216。
图2B示出远侧电极片208的局部截面A-A。所示的电极222层叠在绝缘层206的一部分的上方，其具有多个通道(例如，孔)以使电极222能够联接至接地迹线210的(传导层204的)细长的电极支撑件216。
如在图2A中所示，接地电极迹线210和有源电极迹线212可包括多个电极。每个电极迹线设有三个电极222，然而，也可使用更多或更少的电极。此外，每个电极222可具有圆角以减少钩挂其他装置和/或组织的倾向。尽管上面已在双极电极组件的背景下描述了电极222和与其相关联的迹线，本领域的技术人员将认识到相同的电极组件也可在单极模式中运行。例如，作为一个非限制性实例，与有源电极迹线212和242相关联的电极可被用作单极电极，其中接地迹线210在那些电极的通电期间是断开的。
已通过实验确定具有每多个电极大约为4mm的纵向长度(包括电极222之间的纵向间距)的用于肾性高血压指示的实例实施例提供了关于最优毁损灶大小和深度的有效的组织重建结果，且同时避免了狭窄反应。所示的配置是通过平衡热渗透的深度并避免对与治疗区侧支组织造成热损伤，且同时寻求使电极对的数量最小化以优化最终装置的柔性和轮廓而达到的。然而，所示的配置不是必要的要求，这是因为电极大小和放置形状会根据所需的治疗效果而发生变化。
通过Vessix血管的肾脏去神经射频(RF)球囊导管对三十三个约克夏猪进行肾脏去神经。通过Vessix血管的电极设计推定的肾脏去神经是通过一系列的设置(电极长度、温度和持续时间的函数)而实现的，从而比较在Vessix的16mm圆周电极和具有偏离设计的2mm和4mm的电极之间的手术后第7天和第28天的安全性。检查肾动脉的组织切片以评估组织反应，其包括但不限于在第7天和第28天的损伤、炎症、纤维化和矿化。
用Vessix血管的RDNRF球囊导管治疗肾动脉导致动脉壁和相邻外膜中的一系列变化，其代表从急性“损伤”阶段至慢性“反应性/修复性”阶段的动脉/外膜反应的发展。由于存在有在动脉壁中的这些变化及其至相邻外膜组织中的延伸(被理解为“治疗区”)，在肾动脉内的治疗区域是明显的。
在第7天，所有电极，不管其长度、治疗温度或持续期间如何，均与主要的损伤性反应相关联。然而，无论治疗的持续期间如何，2mm和4mm的电极也与早期的反应性/修复性反应相关联，其中该早期的反应性/修复性反应在使用16mm的RF治疗的情况下在第7天也观测到。无论温度如何，16mm电极所影响的动脉圆周的总范围增加(轻度/中度至明显，分别为大约>75％至100％的所覆盖圆周)，这是相对于通常影响为极小至轻度/中度(分别影响圆周的～<25％至～25–75％)的较短的电极(2mm和4mm)而言，而无论治疗的持续时间如何。
在第28天，无论时间点如何，在除了较短的4mm电极外的所有治疗组中都观测到了频繁的极小的新内膜形成。不管治疗组，在第28天仅很少观测到了轻度/中度的新内膜形成；然而，相对于较短的2和4mm电极，16mm电极却与轻度/中度新内膜的发生率的轻度/且可比的增加相关联。
内皮细胞的剥蚀(即，损失)是任何介入器械通过的常见后遗症，以及使用Vessix血管RDNRF球囊导管进行治疗的预期后遗症。由于内皮细胞在防止血栓形成中的重要性，因此要监控其在剥蚀区域中的恢复。就这点而言，内腔表面的再内皮化的幅度/程度是相对于受影响的动脉的近似圆周进行解释的。
在第7天，与未治疗相比，2和4mm的电极具有更多的具有完整内皮化的动脉部分；且完整的内皮化出现于2和4mm电极的所有动脉部分中。无论剂量如何，在第7天均未观测到经16mm电极治疗的动脉部分具有完整的内皮化。
在第7天，无论治疗如何，通常，总的来说炎症是极小的；然而，无论剂量如何，相对于2和4mm电极，两个16mm电极使炎症总体上有所增加。轻度/中度的炎性浸润很少能在2和4mm电极中观测到，但在16mm电极中很常见。
在图2A的实施例中，每个电极222大约为1.14mm乘以0.38mm，且在电极222之间具有大约为0.31mm的间隙。接地迹线210和有源电极迹线212的电极222以约1.85mm横向间隔开。在一些实施例中，如图2B中所示的实施例中，电极222为离传导层204约为0.038mm厚且在绝缘层206的上方突出0.025mm的金片。在不限制使用其他这种合适材料的情况下，金为良好的电极材料，这是因为其具有良好的生物兼容性、不透射线性并且导电和导热。在其他实施例中，传导层204的电极厚度可在约0.030mm至约0.051mm的范围之中。在该厚度，例如与铜传导层204相比，电极222的相对刚性可很高。因此，相对于使用单个电极，使用多个电极会提高柔性。在其他实施例中，电极可以小到0.5mm乘以0.2mm或大到2.2mm乘以0.6mm以用于电极222。
虽然在绝缘层206的上方平衡金的厚度从而实现良好的柔性且同时保持足够的高度以提供良好的组织接触是重要的设计优化考量，但这会受到在球囊布置或收缩期间避免可能造成钩挂的表面厚度的目标所制衡。这些问题会根据特定手术的其他元素发生变化，如球囊压力。对于许多实施例来说，已确定在绝缘层206的上方突出约0.025mm的电极将在10atm以下以及低至2atm的球囊充气压力下具有良好的组织接触。这些压力远低于血管成形术球囊的典型的充气压力。
传感器迹线214位于远侧电极片208的中心且包括面向传感器接地片218的传感器功率片224。这些片可连接至热感测装置226，如热电偶(例如，T型构造：铜/康铜)或热敏电阻的功率极和接地极，如在图2C以局部截面所示出的。
热传测装置226向近侧连接至传感器功率片224且向远端被连接至传感器接地片218。为了有助于减少总厚度，热感测装置226位于基层202内的开口内。在一些实施例中，热感测装置226为具有0.1mm厚度的热敏电阻，其是异乎寻常的薄-大约为行业标准的2/3。如图所示，热感测装置226位于远侧电极片208的非组织接触侧。因此，当被结合至最终的装置，如导管120中时，热感测装置226被俘获在在电极结构和球囊之间。这是有利的，这是因为在表面安装的电气组件，如热敏电阻，通常具有尖锐的边和角，其可卡在组织上且可能在球囊布置和/或收缩中引起问题。该布置还使钎焊接头免于与血液相接触，这是因为焊剂通常是非生物兼容的。进一步地，由于对热感测装置的布置，其可测量代表组织和电极222的温度。在现有技术中的设计通常采用两种方式中的一个，即要么与组织相接触要么与电极相接触。在此，未采用这些现有方式中的任一个。
从矩形远侧电极片208至中间尾部228，组合的基层202、传导层204和绝缘层206的横向宽度减少。在这里，传导层204形成为包括中间接地线230、中间有源电极线232和中间传感器线234，他们分别为远侧电极片208的接地迹线210、有源电极迹线212和传感器迹线214共同扩展的迹线。
从中间尾部228开始，组合的基层202、传导层204和绝缘层206的横向宽度增加以形成近侧电极片236。按类似于远侧电极片208的方式构造近侧电极片236，其电极的几何形状和热感测装置的布置大致相同，然而也可存在有各种差异。然而，如图所示，近侧电极片236关于沿中间接地线230延伸的中心轴线G-G沿横向偏离远侧电极片208。中间有源电极线232和中间传感器线234在关于中心轴线G-G的相应平行轴线上沿横向与近侧电极片236共同扩展。
从近侧电极片236开始，组合的基层202、传导层204和绝缘层206的横向宽度减少以形成近侧尾部238。近侧尾部238包括近侧接地线240、近侧有源电极线242和近侧传感器线244，以及中间有源电极线232和中间传感器线234。近侧尾部238包括使得能够联接至一个或多个子线束和/或连接器并最终至控制单元110的连接器(未示出)。这些线中的每一个均关于中心轴线G-G沿各平行的轴线延伸。
如图所示，电极组件200具有远侧电极片208和近侧电极片238关于轴线G-G的非对称布置。进一步地，两个电极片的接地电极连同中间和近侧接地线230/240一起大致沿轴线G-G相对齐。已发现该布置具有很多优点。例如，通过基本上共用相同的接地迹线，近侧尾部的宽度仅为中间尾部228宽度的约1.5倍，而不是在如果每个电极片具有独立接地线情况下的约2倍宽。因此，近侧尾部238比中间尾部228中的两个更窄。
进一步地，布置电极片使其共用接地迹线允许进行控制以使哪些电极彼此之间实现互动。当查看单个电极组件时，这不会立即显现，但当将一个以上的电极组件200组装至球囊，如在图1C中所示的时，则会变得很明显。各种电极片可使用固态继电器和多路复用而进行激发和控制且激发时间的范围约100微秒至约200微秒，或约10毫秒至约50毫秒。为了实践的目的，电极片显现为是同时激发的，然而通过将电极以微脉冲(microbursts)快速激发来防止在不同的电极组件200的相邻的电极片之间的杂散电流。可进行这一操作，从而使不同的电极片组件200的相邻的电极片彼此异相激发。因此，电极组件的电极片的布置允许短的治疗时间-10分钟或更短的总电极激发时间，其中的一些近似的治疗时间短至10秒，其中的示例性实施例为30秒。短治疗时间的好处包括当神经组织进行能量治疗时所引起的手术后疼痛最小化、缩短的血管闭塞时间、减少的闭塞副作用和由于至内腔组织的相对较小的热输入而由血液灌流对侧支组织进行的快速冷却。
在一些实施例中，公共接地通常承载源于负电极的500kHz的200VAC以及源于热感测装置226(使用热敏电阻的情况下)的1V信号，该热感测装置226要求对RF电路滤波，从而使热敏电阻的信号能被感测到并用于发生器控制。在一些实施例中，由于公共接地，相邻电极对的热敏电阻可用于监控温度，甚至是在没有激发相邻电极对的情况下进行。这提供了仅激发远侧电极片208和近侧电极片236其中一个时，感测两者附近温度的可能性。
再次参照图1C，各个电极组件140a-d的电极片的布置还实现了在球囊130上的有效放置。如图所示，电极组件140a-d“键”入彼此之中以最大化地使用球囊表面面积。这部分地是通过设置各个中间尾部的纵向长度以将电极片间隔开而实现的。例如，将电极组件140a的中间尾部的长度设置为将其远侧和近侧电极片150a和170a相分离的距离，从而使横向相邻电极组件140b的横向相邻近侧电极片170b键入紧邻的电极组件140a的中间尾部160a。进一步地，在电极组件140b的中间尾部160b和电极组件140d的中间尾部160d之间键合有电极组件140a的远侧电极片150a。因此，各个中间尾部160a-d的长度还要求任何一个电极组件的各个电极片位于不相邻的治疗区中。
沿横向使每个电极组件140a-d的两个电极片相偏离也部分地实现了球囊表面面积的最大化。例如，每个远侧电极片150a-d的向右的横向偏离和近侧电极片170a-d的向左的横向偏离允许相邻的电极片组件键入彼此之中，从而使电极片中的一些沿横向彼此重叠。例如，电极组件140a的远侧电极片150a沿横向与电极组件140b的近侧电极片170b相重叠。此外，电极组件140b的远侧电极片150b沿横向与电极组件140c的近侧电极片170c相重叠。然而，每个中间尾部的长度防止电极片的周向重叠(在该视图中为纵向重叠)，从而在纵向L-L中保持治疗区的非邻接的性质。
电极片的布置和几何形状，以及柔性电路的尾部的布置和几何形状也可便于折叠或以其他方式将球囊收缩至相对紧凑的未扩张的状态中。例如，在扩张直径高达10mm的实施例中，在非扩张状态中的装置可具有小至约1mm的直径。
一些实施例利用具有相同尺寸和构造的标准电极组件，其中在球囊外表面上的电极组件的数量和相对位置成为球囊直径和/或长度的函数，同时电极组件的几何形状在各种球囊尺寸中保持不变。电极组件相对于球囊直径和/或长度的相对定位随后可通过使在给定尺寸球囊上的近邻电极组件的相邻电极片的周向和/或轴向重叠的所需程度或避免的情况而进行确定。然而，在其他实施例中，球囊上的所有电极组件不必是相同的。
图3A-3D示出可与图1A所示系统100一起使用的可替代电极片的配置。图3A示出以类似于电极组件200的方式进行构造的电极组件300，但其具有彼此直接毗连的两个电极片302。
图3B示出以类似于电极组件200的方式进行构造的电极片组件304，但其具有彼此直接毗连的两个电极片306。此外，电极片306具有被布置成关于图1C的纵轴线L-L和图2A的G-G为横向的电极。
图3C示出以类似于电极组件304的方式进行构造的电极组件310，但其具有三个交错并分离的电极片312。像图3B的电极组件304一样，电极片312的特征为横向布置的电极。
图3D示出以类似于电极组件310的方式进行构造的电极组件314，但其具有电极表面面积更大的电极片312。像图3B的电极组件304一样，电极片316的特征为横向布置的电极。
图4A-4C示出可与图1A所示系统100一起使用的可替代电极片的配置。图4A示出以类似于电极组件200的方式进行构造的电极组件400，但其仅具有单个远侧电极片402。
图4B示出以类似于电极组件400的方式进行构造的电极组件404，但其具有单个远侧电极片407，有源电极408的表面面积大于接地表面面积410的。
图4C示出以类似于电极组件404的方式进行构造的电极组件412，但其仅具有单个远侧电极片414，其具有大量多孔的构造以实现更大的柔性。
图5A-5F示出可与图1A所示系统100一起使用的可替代电极的配置。在一些实施例中，所示的电极构造可与图4A-4C的构造一起使用。图5A示出以类似于电极组件400的方式进行构造的电极组件500，但其布置成仅包括单个近侧电极片502。电极组件500还包括用于附接至球囊的细长远侧部分504。
图5B示出以类似于电极组件500的方式进行构造的电极组件506，但其在电极片508上具有相比较大的电极表面面积。
图5C示出以类似于电极组件500的方式进行构造的电极组件510，但其在电极片512上具有相比较大的电极表面面积以及数量更多的电极。
图5D示出以类似于电极组件510的方式进行构造的电极组件514，但在电极片512上具有非均匀的电极配置。
图5E示出以类似于电极组件500的方式进行构造的电极组件514，但其在电极片516上具有相比较小的电极表面面积和较少数量的电极518。电极片516还结合有被安装在相同侧上以作为电极的两个热感测装置520。
图5F示出以类似于电极组件514的方式进行构造的电极组件522，但具有横向布置的电极524和单个热感测装置526。
图2至5F中的电极组件可以双极或单极配置使用。图5G至5I示出单极电极配置的额外实例。在图5G中，在温度传感器532的任一侧具有两个平行的单极电极530阵列。在图5G中，每个单极电极530阵列具有其自身的离散迹线，其中温度传感器532也具有其自身的离散迹线。然而，在其他实施例中，在特定的柔性电路组件上的所有单极电极530可共享单个有源迹线，且温度传感器的两个迹线中的一个也可进行共享，然而，在其他实施例中，用于温度传感器的电源和接地迹线可与(多个)单极迹线相分离。
图5H示出单极电极片的另一种布置，其中所有单极电极536均被联接至单个迹线。图5I示出用于单极电极和温度传感器的另一个替代布置。单极电极片可按纵向和周向偏离的布置(如在图1C中所示)被布置在可扩张装置的周围且可具有类似于图3A至5F中所示那些的几何形状和布置。
治疗方法和控制系统
a.装置定位
图6示出图1A的系统100，用于执行根据本发明的一个非限制性实施例的治疗方法600。在此处，所示的控制单元110被可操作地联接至导管装置，导管装置已被置于身体通道中以使可扩张装置(具有多个电极组件)被置于邻近需要治疗的身体通道的区段S1处。可根据常规的方法将导管装置置于区段S1处，例如，在透视导向下在导丝上方进行。
一旦置于S1处，可扩张装置可扩张，例如，在使用球囊的情况下通过从2-10atm对流体加压而实现。这使可扩张装置的电极与身体通道相接触。
在一些实施例中，控制单元110可测量在电极组件处的阻抗以确定电极与身体通道的对合。在这些实施例中的至少一些中，即使未感测到所有电极的对合，也可进行治疗。例如，在一些实施例中，如果感测到50％或更多电极的对合，则可进行治疗，且可允许低于周向和/或轴向对合的完全一致性。例如，在一些情况下，可定位导管，从而使近侧电极中的一个或多个位于主动脉中并暴露于血液，且对于这种电极所感测的阻抗可能不位于预先指定的范围中(如，例如500-1600欧姆)，其表示对于这些电极没有组织对合。在一些情况下，即使存在低于一致性的电极/组织对合，系统也可允许用户授权以继续进行治疗。接着，控制单元110可激活电极以产生相应数量的毁损灶(lesion)L，如黑色方块所表示的。在电极的激活期间，由于热感测装置的不与组织或电极相接触的独特布置，控制单元可使用电极片的热感测装置以监控电极和组织的热量。以这种方式，在治疗期间，根据需要可将更多或更少的功率供给至每个电极片。
在一些实施例中，控制单元110可应用统一的标准以确定至装置的所有电极的对合。例如，控制单元可对所有电极利用相同的预先指定的范围内的电阻测量。然而，在包括一些，然而不是所有的单极应用的其他情况下，可对不同的单极电极应用不同的标准以确定对合。例如，在一些单极实施例中，每个单极电极可限定通过组织至共用/不同的电极(或多个电极)的离散电路，且那些电路的特征(例如，电阻)可基于在单极电极和共用电极之间的距离、在其之间的组织特征以及装置和周围组织的其他几何形状和特征而显著地变化。如此，在至少一些实施例中，可能需要应用标准以确定对合，该标准取决于，例如在单极电极和共用电极之间的距离而变化(例如，在两个电极之间的距离越大，所需要确定良好对合的阻抗测量结果越高)。然而，在其他实施例中，由于这些距离和其他几何形状中的差异而导致的变化将是极小的或非实质性的，且可应用统一的标准。
图24A-F示出在治疗期间通过控制单元显示的一系列截屏的一个非限制性实例。在图24A中，系统提示用户连接导管。在图24B中，系统确认导管已连接以及关于所连接导管的其他信息(例如，大小/直径)。在图24C和D中，如上面所讨论的，系统可检测电极对合、指示哪些或多少电极处于对合中并请求授权以继续进行操作。在图24C中，所出三个电极(例如，前三个或“近侧”电极)处于对合中，而在图24D中，示出所有的电极均处于对合中。在图24E和F中，系统可在治疗期间和在治疗后显示治疗的某些参数(例如，功率、温度、时间和有效/激活的电极数量)。关于治疗的信息，如前面所述的参数和/或其他信息可通过系统捕获并被保存至存储器。
返回至图6，在完成在区段S1中的规定治疗后，可扩张装置可随后进行放气并被移至未经治疗的区段S2以重复在区段S1中施加的治疗，且类似地被移至区段S3以及根据需要而被移至任何更多的部分。所示的部分是直接相邻的，但也可按一定的距离分开。
在一些情况下，将利用除了在图6中所示那些之外的替代方法。例如，在其他实施例中，将仅在通道中的单个位置上进行治疗，且不一定需要将可扩张装置移至通道中的多个位置。
再次参照涉及减少过多神经活动的肾性高血压的实例，可使用系统以实现非穿孔且非消融的方式来引导能量以影响神经活动。因此，所示的身体通道可以是在区段S1-S3中被神经组织N所包围的肾动脉。在可扩张装置上的电极可被供电以在待受影响的神经N的已知方向上输送能量，能量穿透的深度为能量剂量、电极类型(例如，单极对双极)以及电极几何形状的函数。全部内容通过引用并入本文的题为”用于在身体组织上诱导所需的温度效应”的美国公开号2008/0188912描述了用于在一些，然而不一定是全部的实施例中可能要考虑的电极几何形状和组织治疗区的体积的一些考虑。在一些情况下，可使用实验分析确定神经组织N的阻抗特征，从而可使用导管装置以首先进行特征化且随后用目标方式治疗组织，如本文所公开和描述的。能量的输送和调节可还进一步地涉及累积的损伤建模。
如图所示，每个毁损灶L是在可扩张装置130的相应治疗区A-D中所产生。因此，在一个特定治疗区A-D形成的任何毁损灶L将不会在沿操作轴线O-O的任一点与相邻治疗区A-D的毁损灶周向重叠。在一些实施例中，可扩张装置130的治疗区可具有一个以上的电极片，且因此在这样的情况下，通过那些电极片所产生的毁损灶L可沿周向重叠。在那些情况下，对于特定的解剖结构可能需要更多的毁损灶L或需要一对电极片以在施加治疗前进行诊断例行程序。无论如何，相邻治疗区的电极的周向重叠将不存在。
b.能量输送
根据所需要的特定的重建效果，控制单元可用约0.25至5瓦的平均功率对电极进行1至180秒的通电或以约0.25至900焦耳进行通电。较高的能量治疗可在较低的功率和较长的持续时间内完成，如0.5瓦90秒或0.25瓦180秒。在单极的实施例中，控制单元可用高达30瓦的功率对电极进行高达5分钟的通电，这取决于电极配置和电极与共用接地之间的距离。较短的距离可在较短的时间段提供较低的能量，因为能量在更集中的区域行进则传导损失更少。在用于肾脏去神经的实例实施例中，能量以约5瓦的治疗设置输送约30秒，从而在治疗期间将治疗区加热至约68℃。如上所述，功率需求在很大程度上取决于电极类型和配置。通常，具有较宽的电极间距，则需要更大的功率，其中平均功率可高于5W，且总能量可超过45焦耳。同样地，使用较短的或较小的电极对将需要按比例缩小平均功率，且总能量可小于4焦耳。在一些情况下，功率和持续时间可校准至小于足以导致严重损害的量，且特别是不足以消融血管中的患病组织。已很好地描述了消融血管内动脉粥样硬化材料的机制，包括在美国心脏病学杂志(1985年6月)的第1382-6页中Slager等人的题为“通过火花蚀刻蒸发动脉粥样硬化斑块”的文章；以及StephenM.Fry的“热性和破坏性血管成形术：医师指南”，StrategicBusinessDevelopment,Inc.(1990年)，其全部内容通过引用并入本文。
在一些实施例中，对患者的肾动脉中的一个或两个所施加的能量治疗可在高于可能存在于其他身体通道中的水平下施加且不具有有害的作用。例如，身体的外周和冠状动脉如果在某个热反应极限以上进行加热，则可能产生有害的长期闭塞反应。然而，已发现肾动脉可在这个热反应极限以上进行加热且不会具有有害的作用。
在一些实施例中，可向患者的肾动脉中的一个或两个施加能量治疗以影响肾脏中的交感神经活动，从而使CHF的心脏收缩和舒张形式缓和。对紧邻肾动脉的组织施加治疗热能在降低交感神经神经活动方面是有效的，从而缓解CHF的生物过程和所产生的效果。在一些实施例中，在快速程序(例如，每个肾脏为10分钟或更短的治疗时间)中温和地施加受控剂量的热能以向临床工作人员提供简易程序，且同时提供使患者所感觉疼痛最小化的程序并同时使该程序的效率最大化。本发明的用球囊安装的电极和能量输送方法特别适用于施加能量以减少与慢性高血压相关的交感神经活动，其中慢性高血压与收缩和舒张性CHF相关联或与其相分离。
在一些实施例中，本文所述的电极片可进行通电以进入且随后选择性地治疗靶组织以通过重建所治疗的组织而获得所需治疗结果。例如，通过使用阻抗测量可利用组织特征以识别组织的治疗区。利用在身体通道内的周向间隔的电极的阻抗测量可用于分析组织。在电流路径穿过患病组织时以及在穿过例如内腔壁的健康组织时，在相邻的电极对之间的阻抗测量可能不同。因此，在患病组织的任一侧上的电极之间的阻抗测量可指示毁损灶或其他类型的靶组织，而在其他相邻电极对之间的测量则可指示健康组织。可使用其他特征化，如血管内超声、光学相干断层成像术等以识别要进行治疗的区域，其可与阻抗测量相关联或作为其的替代。在一些情况下，可取的是获得要进行治疗的组织的基线测量(baselinebasements)以有助于区分相邻的组织，这是因为组织特征和/或特征轮廓可能因人而异。此外，组织特征和/或特征轮廓曲线可标准化以便识别在不同组织之间的相关的斜率、偏移等。阻抗测量可在一个或多个频率下，理想地在两个不同的(低和高的)频率下完成。可在约1-10kHz或约4-5kHz的范围中完成低频率的测量，且可在约300kHz-1MHz或在约750kHz-1MHz之间的范围完成高频率测量。较低的频率测量主要代表阻抗的电阻分量并与组织温度紧密地关联起来，而较高的频率测量代表阻抗的电容分量并与细胞组成中的破坏和改变关联。
由于作为阻抗的电容和电阻变化引起电流和电压之间的峰值变化，也会发生阻抗的电阻和电容分量之间的相角偏移(phaseangleshift)。也可监控相角偏移以作为在RF去神经期间评估组织接触和毁损灶形成的方式。
在一些实施例中，可通过结合温和或标准的扩张进行温和加热的方式进行身体内腔的重建。例如，具有被布置在其上的电极的血管成形球囊导管可在扩张前、中和/或后向血管壁施加电势，可选地，该电势可结合处于或显著低于标准未加热血管成形术扩张压力的扩张压力。例如10-16个大气压的球囊充气压力可能适于特定病灶的标准血管成形术扩张的情况下，本文所述的与合适的电势(其通过球囊上的柔性电路电极、被直接布置在球囊结构上的电极或类似物)相结合的修改的扩张治疗可采用10-16个大气压或可受到6个大气压或更少的且可能为低至1至2个大气压的影响。这种适度的扩张压力可能(或可能不)与组织特征化、调谐的能量、偏心治疗和本文所述的用于治疗身体内腔、循环系统和外周脉管疾病的其他治疗方面相结合。
在许多实施例中，在身体内腔扩张前、中和/或后所添加的温和的加热能量可在降低并发症的同时增加扩张的效力。在一些实施例中，这种使用球囊的受控加热可表现出反冲力的减少，这提供了支架似的扩张的优点中的至少一些，且不具有植入物的缺点。可通过将外膜层的加热限制在有害反应阈值以下而增强加热的益处(和/或抑制并发症)。在许多情况下，可使用小于约10秒的加热时间，通常为小于3(甚或2)秒的加热时间提供内膜和/或中膜的加热。在其他情况下，非常低的功率可用于较长的持续时间。通过将电路的驱动势匹配至靶组织相角而将能量有效地联接至靶组织可加强所需的加热效率，这有效地使位于电功率曲线下方的区域最大化。相角的匹配不必是绝对的，且虽然与特征化的靶组织实现完全的相匹配可能具有益处，替代的系统也可预先设定合适的电势以大致匹配典型的靶组织；虽然实际的相角可能未精确地进行匹配，在靶组织内的加热定位可能显著地优于使用标准功率形式。
在一些实施例中，单极(单极性)RF能量施加可在球囊上的任意电极和位于外部皮肤上或在装置本身上的返回电极之间进行输送，如上面所讨论的。在需要深部毁损灶的区域中可能需要单极RF。例如，在单极应用中，每个电极对可用正极性进行供电而不是每一对具有一个正极和一个负极。在一些实施例中，可进行单极和双极RF能量施加的组合，通过改变成对电极的极性而可选择地获得各种深度/大小的毁损灶。
c.目标温度
可控制RF能量施加以限制靶和/或侧支组织的温度，例如，限制对靶组织的加热，从而使靶组织和侧支组织均不会受到不可逆的热损伤。在一些实施例中，表面温度范围为约50℃至约90℃。对于温和的加热而言，表面温度的范围可约为50℃至约70℃，同时对于更强的加热而言，表面温度的范围可约为70℃至约90℃。限制加热以抑制侧支组织的加热至低于约50℃至约70℃的表面温度，从而使块状组织的温度保持为大多位于50℃至55℃以下，这可抑制可能另外导致狭窄、热损伤等的免疫反应。在50℃和70℃之间的相对温和的表面温度可能足以在治疗期间、在治疗后立即地和/或在治疗后一小时以上、一天以上、一周以上甚或一月以上通过组织对治疗的愈合反应而使蛋白键变性和断裂，从而提供较大的血管内腔和改进的血液流动。
在一些实施例中，目标温度可在治疗期间发生变化，且可能为例如治疗时间的函数。图7示出治疗持续时间为30秒的一种可能的目标温度曲线，并具有从标称体温爬升至约68℃的最大目标温度的十二秒。在图7所示的实施例中，在爬升阶段的十二秒内的目标温度曲线是通过其中的目标温度(T)为时间(t)的函数的二次方程所限定的。设置方程的系数，从而使从标称体温至约68℃的爬升斜坡遵循类似于在重力的影响下达到其行进弧线的最大高度的投射体的轨线的路径。换句话说，爬升可设置为，随着达到12秒和68℃在温度的斜坡(d2T/dt2)中具有恒定的减速度且在温度的增加上具有线性减小的斜率(dT/dt)。这种曲线，随着其接近68℃斜率逐渐减小，这可便于在治疗的剩余时间内使所设目标温度的超过目标和/或未达目标最小化。在一些实施例中，图7的目标温度曲线将同样适用于双极或单极治疗，然而，在至少一些单极实施例中，治疗时间也会增加。
图8、9和10示出用于在本发明的各种实施例中的附加的目标温度曲线。图8示出具有变化的上升时间和设置目标温度的曲线(例如，一个具有大约为3秒的上升时间和55℃设置温度的曲线、一个具有5秒的上升时间和60℃设置温度的曲线、一个具有8秒上升和65℃设置温度的曲线、一个具有12秒上升和70℃设置温度的曲线以及一个具有17秒上升和75℃设置温度的曲线)。
图9和10示出利用不同上升曲线的温度曲线，其中的一些相对激进地接近设置的目标温度(例如，“快速上升”的曲线)，其中的其他曲线则不那么激进地接近设置的目标温度(例如，“缓慢上升”的曲线)。已通过实验确定在图10中所示的“中等增强上升”温度曲线提供了用于至少一些治疗方案的最优结果，然而并不是本发明的所有实施例均仅限于该温度曲线，且不同的治疗和不同的情况可有利地使用其他曲线。中等增强上升可以是一个实例实施例，这是因为其有效地将靶组织加温至目标温度且同时避免了更激进的加热曲线可能会导致的有害的微观热损伤，同时还提供了最佳的总体治疗时间。对于所示的各个目标温度曲线，可利用具体为二次方程或近似于二次方程的温度爬升斜坡，然而，也可使用有效地加热组织、优化治疗时间并避免对靶组织的热损伤的任何函数或其他曲线。然而，在其他的实施例中，将不一定需要利用达到所有这些目标的温度曲线。例如但非限制地，在至少一些实施例中，治疗时间的优化可能不是必要的。
进行台上实验和动物实验以优化和验证在Vessix系统的去神经实施例中所使用的目标温度曲线。下面总结了支持选择中等增强上升温度曲线以作为实例实施例的台上实验和分析。
进行测试以确定哪些上升时间算法将提供最佳水平的有效性和安全性。一些早前的上升时间算法已能够尽快地简易地到达所设置的温度，且据认为，这不一定是在至少一些情况中的最好做法。用三个无量纲参数定性地评估效力。其目的是基于目视检查确定将在治疗区对组织产生最小量的炭化、变性和脱水并同时还提供良好效力的算法。
将水浴升至37℃以模拟体温，且将肝脏样本置于水浴中以模拟体内的条件。通过记下与组织相接触的每个双极电极对的电极组织界面的阻抗值验证装置的良好对合。较高的阻抗(>500欧姆)被用作良好对合的基准。
在运行图9和10所示的温度曲线后，在每个治疗部位上测量肝脏样本表面处的毁损灶的长度和宽度、穿透深度和在2mm深度的毁损灶的长度和宽度。分析者不知道是按哪种顺序完成的哪些治疗，从而减少报告偏差。也记录了任何观测到的明显组织损伤。
图11和12以表格形式示出了所创建的以将穿透深度与其他效力测量相关联的效力度量。首先是用穿透深度除以在表面处的毁损灶的面积的平方根。该度量以无量纲的形式将至表面上的毁损灶损伤的深度与表面毁损灶的面积关联起来。100％的值表示穿透深度等于表面毁损灶的平均大小。下一个度量为2mm处的面积除以表面处的面积。该度量显示出热量是如何良好地穿透组织的。100％的值表示在2mm深度的面积和表面面积是相等的。最后一个度量为穿透深度乘以2mm处的毁损灶的宽度并除以表面处的面积。该数字提供了关于毁损灶大体形状的信息以及能量是否趋于沿径向从电极进行传播或穿透组织。100％的值表示毁损灶大小的横截面积等于毁损灶表面的大小。
在仔细审查所有实验数据后，决定中等增强的上升曲线是用于某些实施例的最好的温度上升算法，然而，其他目标温度曲线也可结合本发明所公开的实施例而适合地进行使用。
d.控制算法
图13和14示出一种用于基于目标温度曲线(如上面所述和在图7-10中所示的那些)或其他曲线控制电外科装置(如上面所述以及在图1-6中所示的那些或其他装置)的能量施加方法的一个实施例。控制方法可使用图1所示的控制单元110和/或控制软件的处理功能予以执行，如上面进一步详细描述的或以其他方式进行。在至少一些实施例中，控制方法提供了在装置的各种治疗位点进行温度或其他治疗参数的精细调节，同时利用相对简单并稳健的能量发生器以同时对单个输出设置(例如，电压)下的电极中的几个或其他输送位点中的几个进行通电，其可使系统的成本、大小和复杂性最小化。控制方法可在治疗的任何时间段期间使与目标温度或其他治疗参数的偏离最小化，并因此使对能量发生器的需求(例如，电压需求)中的变化最小化。
在一些实施例中，将需要基于目标温度曲线(如上面所述的那些)来调节RF或其他能量的施加，以提供避免施加高的瞬时功率的温和且受控的加热以及在微观水平上的相关联的组织烧灼或其他损害，其可能不合意地导致热阻挡或以其他方式导致在装置/组织界面的热传导和热传递中的净减少。换句话说，通过避免温度中较大的摆动和所产生的较大量的能量的瞬时施加以重建在目标温度附近的温度，可保留紧接界面位置处的组织完整性。组织干燥可导致热传导性的净损失，导致减少将能量越过电极/组织界面温和地输送至靶组织以进行治疗的有效转移。
本领域的技术人员将理解虽然已提出图13和14的特定的控制方法是用于在上面已描述的特定的电外科装置的背景下进行说明，但这些控制方法和类似的方法仍可有益地被施加至其他电外科装置。
通常，图13和14的控制方法的实施例力求将各种治疗部位保持在预定的目标温度上，如图7-10的目标温度曲线中的一个上。在该实施例中，这主要是通过调节RF发生器的输出电压并确定在给定的时间段要对哪些电极进行通电(例如，通过在那个周期内打开或关闭特定的电极)而完成的。
发生器的输出设置和电极的切换可通过考虑所测量的温度以及之前期望输出设置的反馈回路进行确定。在特定的治疗周期(例如，治疗的25毫秒的时段)期间，电极中的每一个可被识别为三个状态中的一个：关闭、通电或测量。在一些实施例中，如果满足一定的标准，电极将仅处于通电和/或测量状态中(通电的电极可能也正在进行测量)，其中默认的电极状态被关闭。已被识别为通电或测量电极的电极可能在该周期的一部分内或在整个周期内具有施加的电压或检测温度信号。
对图13和14的控制回路实施例进行设计以保持尽可能多的候选电极尽可能地接近目标温度，且同时使温度变化最小化，并因此使不同治疗周期的电压需求中的变化最小化。图15示出用于电极的4个治疗周期的示例性时间/温度图，其示出了保持目标温度的控制算法的一个实施例。
现在将详细地描述图13和14的控制回路实施例。
如在步骤1300所指出的，每个电极被初始设置为关闭。在步骤1302，电极中的一个被指定为用于该治疗周期的主电极。如下面进一步详细讨论的，在治疗期间，所指定的主电极将因治疗周期的不同而发生变化(例如，通过所有可用的电极的周期)。可通过访问查找表或使用用于识别主电极和根据不同的治疗周期改变选择的任何其他合适的功能确定将哪个电极指定为主电极。
在步骤1302，也可将附加电极指定为候选的电极以用于在该治疗周期内进行通电和/或测量。对于该治疗周期而言，指定的附加电极可凭借相对该治疗周期所指定的主电极的某些关系或缺少某些关系而为候选的。
例如，在一些双极电极的实施例中，在电外科装置上的电极中的一些可按一种方式进行布置，从而如果在治疗周期内同时对主电极和那些附加电极进行通电，则可能在主电极和那些附加电极之间存在电流泄漏，其可能不合意地导致对相关联的热感测装置所进行的温度测量的干扰、在每个电极输送的能量量的不准确性或其他不良后果。例如，在图1C中所示的实施例中，如果电极片150c被指定为主电极，则可能考虑不将具有紧邻或接近电极片150c的正极的负极的电极片150d和170d作为用于该特定治疗周期的测量和/或通电的候选，这是因为其邻近所指定的主电极引起泄漏。此外，在这个实施例中，可考虑不将具有紧邻或接近电极片150c的负极的正极的电极片150b作为候选者，这是因为其也是邻近所指定的主电极引起泄漏。此外，在该特定的实施例中，也可考虑将电极片170b作为非候选者，这是因为其位于与引起泄漏的邻近电极片150b相同的柔性结构上。最终，在该特定的实施例中，将考虑将电极片150a和170a作为候选者，这是因为他们邻近非候选。
作为另一个非限制性实例，在一些单极电极实施例中，候选电极为单极电极，具有与和主电极相关联的电路的一个或多个测量或估计特性类似的测量或估计电路特性。换句话说，在一些单极系统中，可能仅希望同时对单极电极进行通电，其中单极电极限定大致与通过主单极电极所限定的电路(例如，通过单极电极、共用电极和通过患者组织的路径所限定的电路)相类似的电路。在一些情况下，这可便于在通电期间实现电流的均匀性。在其他实施例中，预定的表格或其他列表或关联将基于当前的主电极确定哪些电极是候选电极。
在至少一些实施例中，将断开与非候选电极相关联的开关以将非候选电极与系统电路的其余部分相隔离。在至少一些实施例中，该切换也可或替代地用于另外使可用于通电的可用电极对的数量最大化，其条件是在电极对之间的共用接地不受切断的影响。
在其他实施例中，电外科装置可被配置成避免发生泄漏的可能性或以其他方式考虑这种泄漏，且因此，装置的所有电极可以是用于在治疗周期内进行通电和/或测量的候选。
在一些实施例中，将电极指定为主电极、候选或非候选可通过序列矩阵或阵列中的查找表而确定，其识别每个电极的状态以及指定主电极的顺序。在一个非限制性实施例中，主电极指定沿周向通过近侧电极并随后沿周向通过远侧电极(例如，在图1C中，顺序可以是170a、b、c、d，150a、b、c、d)进行循环。然而，也可使用任何模式或其他方法，包括优化与序列中的下一个之间的距离、序列中的下一个的接近性或分布的均匀性的那些。
在一些实施例中，附加条件可导致将在一个特定的治疗周期和/或治疗的其余时间内将特定的电极设置为关闭。例如，如下面所讨论的，在治疗期间，可允许高达4℃的温度过冲(例如，即使这种过冲导致了电极不被通电，电极也不一定被设置为关闭且仍可用于测量)；然而，在至少一些实施例中，如果八个连续的治疗周期测量到特定电极的温度过冲，该电极将被设置为在治疗的其余时间内关闭，这使得治疗另外继续且不会以其他方式改变控制回路的过程，如下面所讨论的。
在步骤1304，确定用于主和其他候选电极中的每一个的目标电压。在这个特定的实施例中，用于特定电极的目标电压可基于与该电极的治疗部位相关联的温度误差以及为该电极所计算的上一次的目标电压(虽然不一定会被施加)而进行确定。可通过测量在治疗部位的当前温度(例如，利用与接近该治疗部位的电极相关联的热传感装置)并确定在治疗中瞬时所测量的温度和目标温度之间的差异而计算出温度误差。
本领域的技术人员将理解，虽然该特定实施例被描述为使用电压作为控制变量，但功率也可被用作电压的替代以作为控制变量，例如，基于功率和电压之间已知的关系(即功率等于电压乘以电流或阻抗)。
图14示出用于确定电极的目标电压的子程序的一个实施例。在1402，通过从实际温度(T)(例如，通过与该电极相关联的热敏电阻所测量的)减去在该时刻的目标温度(Tg)计算与目标(Te)的温度误差。在1404，确定在1402所计算的温度误差是否大于4℃(即，如果目标温度为68℃，则确定热敏电阻所计算的温度是否大于72℃)。在1406，如果温度误差大于4℃，子程序则在该治疗周期内将目标电压0分配给电极。如果温度误差不大于4℃，子程序继续进行至1408并确定温度误差是否大于2℃。如果温度误差大于2℃，在1410，子程序将该电极的上次分配的目标电压的75％的目标电压分配给电极。如果温度误差不大于2℃，在1412，子程序可基于方程式向该电极分配目标电压：
V＝KLVL+KPTe+KI∫t t-nsecTeAVE
其中：
V为目标电压；
Te为与目标的温度误差；
VL为上次分配的电极电压；
KL、KP和KI为常数；以及
n为0至t秒的范围内的时间值。
在一些实施例中，包括图14的实施例，所使用的方程式可以是：
其中：
V为目标电压；
Te为与目标的温度误差；
VL为上次分配的电极电压；
KP为根据比例控制的常数；以及
KI为根据积分控制的常数。
在一些实施例中，可能有利地是仅使用上次分配的电极电压以确定目标电压，而非使用根据早前治疗周期的电压的平均值或电压，这是因为，在一些情况下，使用早前的电压可能是造成重点为目标温度精密控制的实施例的计算误差的源头。
返回图13，一旦确定了用于主电极和其他候选电极的目标电压，在步骤1306，则确定用于主电极的目标电压是否大于0。如果否，在1308，则将用于该治疗周期的RF发生器的输出电压设置为在1304确定的用于其他候选电极的最低目标电压。如果在1304确定的用于主电极的目标电压大于0，在1310，则将用于该治疗周期的RF发生器的输出电压设置为主电极的目标电压。
在步骤1312，具有大于0的目标电压的主和其他候选电极被识别为要进行通电的电极。在可替代的实施例中，如果所确定的用于那些电极的目标电压比所设置的电压大6V，则仅对除了主电极以外的候选电极进行通电。
在其他的实施例中，如果所确定的用于那些电极的目标电压比所设置的电压大1、5或10V，则仅对除了主电极以外的候选电极进行通电。
在步骤1314，确定要通电的电极当前所在的温度是否大于68℃。在步骤1316，温度高于68℃的那些电极被关闭或以其他方式防止对那些电极在该治疗周期内进行通电，并在设置的电压对另外满足上述标准的那些电极进行通电。随后，另一个治疗周期开始，图13的控制回路重复直到完成治疗。在一些实施例中，每个治疗周期与前一个和下一个周期不重叠(例如，将在下一个周期的步骤开始前彻底完成图13的步骤)，然而，在其他实施例中，周期可能至少在一定程度上是重叠的。
图16-23为采用Vessix系统进行肾脏去神经的治疗的温度(目标和实际的)和目标电压随时间变化的图，其利用了图13所示的控制回路将装置的八个电极的实际温度调节为目标温度曲线。应理解的是在这些图中画出的目标电压与被施加至电极的实际电压不同，这是因为，如上所述，电极中仅一个的目标电压被用于设置每个治疗周期中施加的实际电压。如在图16-23中所示，图13所示的控制回路起作用以精确地将在装置的每个电极的实际温度保持在目标温度上。还如在图16-23中所示，在一些情况下，所测量的阻抗会随治疗过程而减少(特别是在治疗的开始阶段)，这反映了响应于高频RF能量，组织中的离子流动性增加。
已通过实验证明当如上所述的温度控制的示例实施例，当被用作进行肾脏去神经的Vessix系统的一部分时，其有效地降低了去甲肾上腺素(NEPI)的浓度。在一个实验中，在治疗后的第7和28天，评估用于肾脏去神经的Vessix系统在健康的幼年约克夏猪中的效力和安全性，包括在治疗后的第7天评估肾脏的NEPI浓度水平。图25为概括了用于该特定实验的研究设计的表格。组1和2的效力测量为在第7天对每只动物在经治疗的动脉对未经治疗的对侧控制肾脏中的NEPI水平百分比减小。图26示出两组的NEPI百分比减小(按平均值+/-SD)。在研究期间，任何动物的体重、体况评分或临床病理学参数不具有显著的变化。总的来说，在所有时间点上的各组的平均基线血管直径是类似的。对经治疗血管计算管腔径获得(luminalgain)或损失(平均预剖检-平均基线直径)，且当与未经治疗的动物的血管相比时，其表现出类似的管腔径获得。在图27-30中示出在肾动脉治疗前和RF治疗后的第7天和第28天的代表性的血管造影图像。经血管造影分析未检测到急性或慢性穿孔、剥离、血栓或栓塞。
e.神经信号刺激和监测
在至少一些上述实施例中或替代的实施例中，肾脏去神经治疗方法和系统可提供神经信号的刺激以及对在紧邻所治疗的肾动脉的组织中的神经信号反应的监测。在一些情况下，该神经活动的电记录图可提供对去神经治疗的效力的评估和/或提供调节治疗的反馈。在至少一些实施例中，这种电记录图提供了神经活动是否存在和/或是否已关于测量基线发生转换(例如，降低)的评估并且不涉及对紧邻肾动脉的神经组织的存在进行映射或量化。
在一个实施例中，用于输送去神经治疗的相同电极组件，如在图1C中所示的远侧和近端侧电极片150a-d和170a-d上的双极电极对，也可被配置成刺激神经信号并监测神经信号反应。例如，在近侧电极片150a-d中的一个上的近侧双极电极对中的一个可被用于刺激神经信号，且在远侧电极片170a-d中的一个上的远侧双极电极对中的一个可被用于监测神经信号反应。或者，远侧双极电极可用于刺激且近侧双极电极可用于监测。在这些或其他实施例中，可通过轴向或周向相邻的电极对进行刺激和感测。
具有如上文在图2A的背景下描述的大小、间隔、其他几何形状和其他特征的电极222可足以刺激和监测神经信号，然而，在替代实施例中，电极可进一步地减少其大小和/或其他特征可进行修改以提供较高的信号分辨率。也可对本文所述的系统和装置做出其他修改以使对神经信号的刺激和(特别是)监测的干扰最小化。例如，在一些实施例中，系统电路(如RF发生器的内部电路)的布局和/或与导管/柔性电路相关联的配线的配对、扭转和其他特征可进行优化以减少电路的固有电容，从而提供减少的电磁通量。
在替代实施例中，用于刺激和/或监测神经信号的电极可与用于输送能量治疗的电极不同。刺激/监测电极可具有用于刺激/监测而优化的位置、几何形状和其他特征，且能量输送电极可具有用于输送能量治疗而优化的位置、几何形状和其他特征。图42示出包括用于输送能量治疗的电极(类似于图10所示的电极)和用于刺激和监测神经信号的单独的电极(在这里，采用位于可扩张装置的远端和近端上的周向环形电极的形式)的导管的一个实例。图43示出包括载有用于刺激和监测神经信号的环形电极的单独的近侧和远侧可扩张装置的导管的一个实例。图42和43的电极中每一个可以是双极电极、单极电极或可构成在近侧和远侧电极环之间的双极电极。如在图24D中所示，可在用户界面上示出电极的示意性的表示以识别可用于进行通电的电极区，且可进一步地包括通过测量阻抗而指示足够的组织对合。由于用户界面可按示意性的形式中示出电极配置，但应理解的是，示意图像不应受限于在可扩张装置上存在的电极构造的类型。电极可以是环、双极对、点电极、轴向细长电极等中的任何一个或多个。
在单极实施例中，电极用作用于在治疗期间进行刺激和感测的正极，而单独的负极则用作接地。负极可位于可扩张结构上，其位于导管本体的一个或多个点上或以接地片的形式位于患者的体外。在单极构造中，信号处理和过滤(如下面进一步所描述的)为期望选项，这是因为在能量输送和神经反应检测之间的幅度具有相对较大的差异。
根据图1A所示和所述的控制单元110的RF发生器和其他电路可用于生成神经刺激信号并监测反应，然而，在其他实施例中，单独的装置可与用于生成神经刺激和/或监测反应的系统相关联。
在一个实施例中，神经刺激可以是通过第一电极在约1秒或更短或约0.5毫秒期间施加的约0.1V至约5V或约0.5V的范围中的电压，随后则是脉冲宽度调制，其可冲击神经组织以传播神经信号。脉冲信号可采用任何形式，其中方波就是一个实例形式，这是因为波形式的快速通/断性质利用没有缓升或从峰电压有效地刺激了神经反应。
可通过测量响应于刺激的神经信号的幅度、响应于刺激的神经信号的速度和/或神经信号的分级幅度中的一个或多个来评估神经活动。在这里，分级幅度是指与治疗前基线相比的神经传导信号的净减少和变化。预期治疗前信号将会具有较对较大的幅度和较平滑的斜率过渡，而源于已接收至少一些治疗的神经的信号则被预期将会具有较对较低的幅度和不那么平滑、突然或断裂的斜率过渡，这表示因治疗导致的中断的神经传导。这些测量可通过测量在第二电极处的电压变化和/或在刺激和反应之间所测量的时间来确定，并且在至少一些实施例中可利用高和/或低通滤波以将神经信号与背景噪声区分开来。
目前，介入能量输送治疗，如肾脏去神经是基于解剖学标记而进行的。在肾脏去神经的实例中，已知大多数的神经均位于沿肾动脉的长度上。治疗后的评估则是基于次级效应的，如NEPI和血压的降低，其通常不是直接指标且不指示神经的活力。
在本技术的当前状态下，没有可用于在肾脏去神经手术中直接实时评估肾神经的功能性行为的手段。针对该问题的解决方案是在肾动脉内肾神经的附近使用交流或直流输送亚阈值或低刺激信号，从而在肾脏去神经治疗前和后访问其活动力。
高分辨率快速神经活力测量可经多个局部电极，如在图1B和1C中所示的那些而实现，然而，应注意的是实施例不仅限于球囊上的双极柔性电路电极。可采用任何适于安装至基于导管的可扩张结构的电极构造(单极或双极)；环形电极、线性或螺旋电极、点电极等可被安装至笼、球囊或用于导管系统中的任何其他这种类型的结构。
测量技术在神经的路径上方采用来自至少一个电极的电刺激以唤起生成沿所刺激的神经纤维传播的动作电势。随后在另一点上记录动作电势。该技术可用于随着神经脉冲沿神经向下流动而确定神经脉冲传导的充分性，从而检测神经损伤的迹象。在电极之间的距离和使电脉冲在电极之间行进的时间用于计算脉冲传输速度(神经传导速度)。传输速度的降低表示神经受损。
在肾神经电刺激之后的速度、幅度以及反应的形状将经球囊导管上的多个电极进行测量。异常发现包括传导减慢、传导阻滞、缺少反应和/或低幅度反应。
参照图44和45，电信号的形态指示神经传导中的变化，如通过与缓慢传导相结合的分级程度中的变化所证实。图44示出在治疗前或基线状况中的代表性的神经信号4401。图45示出在已接收至少一些能量治疗后的代表性神经信号4501。当比较信号4401和信号4501时，显而易见的是，神经信号的幅度已减小，且同时脉冲宽度已增加。而且，很明显的是，信号4501的斜率和斜率中的变化远没有信号4401的斜率和斜率中的变化那么平滑。这说明了神经是如何对本发明主题的能量治疗作出反应的；随着能量的输送，神经传导特性降低或消除，从而引起神经信号减少且使其不那么连续并具有较慢的速度。
可使用信号滤波优化神经信号的测量以将心脏的电信号、刺激信号和系统噪声的影响从神经感测电路滤除，从而优化电路的精确性和灵敏性。信号滤波可通过如带通滤波器等工具而实现。例如，可采用在约1Hz至约500Hz范围中的具有100Hz的实例值的低通滤波器以及在约1kHz至约10kHz范围中的具有5kHz的实例值的高通滤波器建立要通过电路进行感测和测量的信号的频带。随后，将测量用作反馈，该反馈被应用于调整治疗能量输送的能量控制算法。
在一个单极实施例中，感测来自更广的组织范围，这是因为能量从电极的一个或多个正极流向负极或共用的接地路径的负极。将该概念应用至图1B和1C所示的实施例，实例极性将使用外部贴片(未示出)作为正极，而电极组件140a-d则用作用于神经信号测量的共用接地电路的负极。在这个为了感测目的将看似能量向后的应用，电极组件140a-d更接近有关神经组织并因此可通过用作用于感测的负极而提供改进的感测精确性。在治疗的能量输送模式中，外部贴片和电极组件140a-d可进行切换，从而使电极组件140a-d为正极且外部贴片为用于接地的负极。
在一个双极实施例中，感测来自局部的组织范围，这是因为电极组件140a-d的正极和负极是紧邻的且因此所感测的组织体积比在单极构造中更局部集中化。在双极布置中可能需要使电极的两极紧密接近，这是因为两极的接近性允许实现固有的较小量的能量输送以对组织通电以及由于在两极之间具有较小的组织体积而实现固有的较高程度的测量分辨率。此外，电极组件140a-d构造提供了近侧/远端侧线性间隔，其允许沿已在本文描述的路径传感和测量神经信号的线性行进。
神经信号刺激和测量可能发生在能量治疗前、中和/或后。在一个实施例中，在治疗前评估神经活动以建立神经活动力的基线水平，且随后在治疗后重新进行评估以确定是否已产生神经活动力变化的阈值水平。神经信号幅度的百分比减少、信号斜率分级的程度、神经信号脉冲持续时间的增加和神经信号脉冲之间的时间的增加中的任何一个或多个可用于测量指示靶组织中的去神经已经发生了或正在发生的过程中的组织反应。换句话说，神经活动力的全部破坏可能是去神经治疗的延迟反应，然而在去神经治疗中或之后的发生的神经活动力的一些降低足以表示治疗的有效性。在可替代的实施例中，有效的去神经特征可为其中未检测到响应于预定刺激的神经信号。
神经信号的评估可能也或替代地在能量治疗期间进行。例如，图13所示的控制算法可进行修改以允许在每个电极的激活周期前或后对所刺激的神经活动力进行时间度量的测量(这种测量是以毫秒、微秒、纳秒、皮秒等中的任何一个为数量级的)。这些周期内测量可与治疗前的基线、之前周期的测量或其他标准进行比较。
在一些实施例中，不管是否在治疗前和后、在每个治疗周期之间周期性地或在一定数量的治疗周期后周期性地进行了神经活动力的评估，源于神经活动力评估的数据可用于建立或调整用于去神经治疗的参数。例如，在图13和14所示的实施例中，虽然用于每个周期所设置的电压可以是之前施加和测量的电压和平均温度误差的函数，但在治疗温度的总时间可以是所测量的神经活动力的函数或所测量的神经活动力与之前测量或预先设置基线的偏离的函数。在这样的算法中可以考虑所测量的神经信号的幅度、神经信号的速度和/或分级幅度中的一个或多个。因此，如果在去神经治疗的初期测量到神经活动力的显著降低，则可缩短总的治疗时间。相反地，如果神经信号的评估未测量到神经活动力的降低，则可延长总的治疗时间。当然，源于神经信号评估的反馈可用于改变去神经治疗的额外或可替代的参数。
神经信号的测量可被直接集成至本文所述的能量输送和控制方法中。由于候选电极是根据控制算法进行选择和通电的，因此可将神经信号测量的附加函数集成至控制算法中，从而使神经反应的附加控制因素增加了能量输送的精密性且达到治疗反应，且同时避免输送过多的能量，从而尽最大可能地保存治疗前的组织细胞状态。如在图13A中所示，附加的控制回路步骤1313可用于评价是否已满足神经信号降低的阈值。如果未满足神经信号降低的阈值，控制回路随后则前进至回路步骤1314以确定候选电极是否已达到温度阈值。如果在回路步骤1313，确定神经已达到信号降低阈值，则可取消选择电极作为待通电的候选电极。
小/支路血管和其他通道的治疗
本文所述的系统和装置可有利地用于其他基于能量的治疗系统和装置不适合的情况中。例如，本文所述的系统和装置的实施例可用于对于使用其他基于导管的能量治疗系统而言太小的血管和其他通道中。在一些情况下，本文所述的系统和装置可用于直径小于4mm和/或长度小于20mm的肾动脉或其他血管中。其他因素，如血管的曲折性和治疗部位对不应接收治疗的区域的接近性，可能是使用早前的装置所进行的治疗，但非当前描述的系统和装置的至少一些实施例的禁忌症或因其他方式而不适用的。
图1D和E示出每一个均具有三个电极组件的4和5mm的球囊。然而，这些电极组件的特定几何形状和在前面的章节中所描述的其他特征便于在较小直径的球囊，如1、2或3mm球囊或具有其中间大小的球囊上使用。在一些情况下(如在一些1mm实施例中)，球囊可不包括导丝内腔。图46示出具有由可从DuPontTM购得的柔性聚酰亚胺膜制成的主体4601的球囊的一个实施例，其中的肩部4602由标准球囊材料制成。在一些情况下，图46的球囊的本体可消除对在球囊上使用单独层的柔性电路组件的需要，如取消在图2B中所示的基层202，从而减小柔性电路组件的轮廓。
上述的系统和装置的其他特性也可便于在相对较小的血管中进行使用。例如，将能量治疗输送至小直径的血管可能需要对所输送的能量的量和/或治疗所导致的温度增加进行特别精细的控制。就这点而言，特定的电极能量输送几何形状、控制算法和上述的其他特性可能会使本系统和装置特别适于这种情况。
图47示意性地示出从主动脉4702分支至肾脏4703的典型的主肾动脉4701。其示出了本发明的一个实施例，其中对导管的球囊和电极组件4704进行扩张和定位以进行组织的治疗。施加能量剂量并随后对球囊进行放气和移除或重新定位。
图48示意性地示出从主动脉4803分支的主4801和副肾动脉4802，其均延伸至肾脏4804。副动脉大小的范围为约1mm直径至约5mm直径。图48所示的肾动脉应被理解成可能在体内因受试者的不同而发生变化的肾动脉的简单的表示。例如，动脉可能在直径、长度、曲折性、位置和数量上发生变化。此外，这些变化可能是有关于每个动脉以及关于每个受试者的。图48示出用于在较小的副动脉中进行治疗而定位的第一球囊导管A以及用于在较大的主肾动脉中进行治疗而定位的第二球囊导管B。
在实践中，如果两个动脉的直径足够接近以允许实现完全的球囊扩张以及与动脉内腔组织的接触，导管A和导管B则可能是相同的一个。导管A和导管B还可根据每个动脉的可治疗的长度而沿各动脉的长度进行重新定位。如果医师需要的话，还可同时治疗主和副动脉。
据申请人所知，先于本发明之前，由于对小动脉的过热、当在具有较小的横截面的内腔区域中进行操作时的空间限制以及在曲折的通道中进行导航的困难，治疗副肾动脉尚不可能。由于本发明的实施例在球囊上使用可扩张基于导管的结构和球囊上的柔性电路电极，因此消除了“一个尺寸适用所有”装置的限制。本发明的球囊和电极组件是逐渐按大小排列和布置的以便精确地控制用于内腔直径的增量范围的热能剂量。换句话说，球囊和电极组件是逐渐按大小排列和布置的以在具有相应大小的内腔中进行优化的操作。选择电极的数量以避免组织的过热。基于球囊的可扩张结构能够灵活地导航至具有较小的未扩张直径处的位置。扩张球囊的大表面的接触允许实现组织接触中的均匀性，同时避免了单点探针或其他这种类似设计的弯曲和/或紧密的空间限制。
在25-30％的人类患者中存在有副肾动脉；然而，这些患者已被排除在之前的肾脏去神经的研究之外。在REDUCE-HTN临床研究(Vessix血管的临床研究方案CR012-020的全部内容通过引用并入本文)中，四个受试者的子集经历了成功的使用Vessix肾脏去神经系统(VessixVascular,Inc.；LagunaHills，CA)进行的主和至少一个副肾动脉的治疗，该系统包括具有按纵向和周向偏移的模式被安装在球囊表面上的高达8个不透射线的金电极的0.014英寸导丝上(over-the-wire)的经皮球囊导管。在一个示例性实施例中，导管被连接至专用的自动化低功率RF双极发生器，其在约68℃输送温度受控的治疗剂量的RF能量约30秒。该群的平均基线诊室血压(OBP)为189/93mmHg。除了每个主肾动脉平均进行的10.5次去神经外，以每个副肾动脉平均8次去神经的方式治疗该群。
在这个研究中，对于四个受试者而言，未报告有围手术期并发症且手术后立即进行的血管造影术指出无肾动脉痉挛或任何其他有害的影响。这四个受试者在手术后两周表现出了改进，其OBP减少的平均值为-32/-16mmHg(190/97至167/91；175/92至129/70；192/94至179/91；183/87至138/55)。
图49和50示意性地示出肾脏去神经治疗的非限制性实例，其中使用电极组件的电极子集选择性地输送能量。图49示意性地示出包括分支4902的肾动脉4901。在这种情况下，球囊和电极组件4903位于肾动脉中，从而使电极4904中的一个紧邻将分支连接至肾动脉的口，且因此不与血管壁对合。如上面在一些实施例中所描述的，根据本发明的系统和方法可被配置成选择性地对与血管壁相对合的电极或电极的子集(例如，图49中所示的电极4905和4906)进行通电，且同时不对不与血管壁相对合的电极或电极的子集(例如，电极4904)进行通电。本领域的技术人员将理解，除了图49所示的实例外，各种其它因素可能会在电极组件和血管壁之间导致不那么完全的对合，这些因素包括但不限于血管的曲折性、血管直径的变化、血管壁上积聚物存在与否等。
图50A和B示意性地示出肾脏去神经治疗的一个非限制性实例，其中用位于肾动脉5001的两个位置的电极组件和球囊进行能量治疗。在图50A中，对球囊进行定位，从而使所有电极5002-5005均位于肾动脉5001中并作为用于通电的可能的候选者。在图50B中，在图50A所示的位置上已进行了能量治疗后，球囊和电极组件已被取回，从而将其一部分保留在肾动脉5001中并使其一部分位于主动脉5006中。在图50B中所示的定位期间，本发明的系统和方法的某些实施例将被配置成仅选择电极5002和5005(以及位于肾动脉5001内和/或与肾动脉5001的壁相对合的任何其他电极)作为用于通电的可能的候选者，其中在主动脉5006中的电极被识别为通电的非候选者。如图50A和B所示，本发明的某些实施例可便于将能量输送至在或紧邻将主动脉5006连接至肾动脉5001的口处的组织，其在至少一些患者体内可能是神经组织相对较高集中的区域。
阻抗补偿
如本文所指出的，可使用双极电极对进行消融、调制或以其他方式重建组织，包括肾神经。所考虑的电极中的至少一些可被布置在图51所示意性地示出的柔性电路和/或二分体5040上，该柔性电路和/或二分体5040可安装于在远端电极片5050上具有远端双极电极对(例如，一对双极电极包括一个以上有源电极以及一个以上接地电极)以及在近端电极片5070上具有近端双极电极对(例如，该对双极电极也包括一个以上有源电极以及一个以上接地电极)的球囊上。如上面所指出的，远端电极片5050、近端电极片5070或两者均可包括温度传感器(例如，热敏电阻)。
每个二分体5040可利用被布置在中间尾部5060上的共用接地迹线，该中间尾部5060被连接至被布置在远端电极片5050上的接地电极以及被布置在近端电极片5070上的接地电极。共用接地可便于实现从电极片5050至电极片5070的电流漏泄，特别是当激活电极片5050时。在一个实例中，当激发或以其他方式激活远端双极电极对时，电流可从远端电极片5050的有源电极流至近端电极片5070的接地电极。如果发生这种情况，由于该电流漏泄，在远端电极片所测量的阻抗可能不那么精确。如果所测量的阻抗的精确性由于至相邻的电极片的电流漏泄而出现显著的偏离，系统则可将给定的电极片归类为不与肾动脉相接触、仅部分地与肾动脉相接触或被布置在远离肾动脉的血流中的主动脉内。在一些情况下，由于电极片未与肾动脉的壁相接触，这可能导致系统不正确地将电极片识别为不适于激活。因此，当治疗可能已经是适当的时候，系统可能不在电极处进行治疗。或者，当治疗可能已经是不适当的时候，系统可能在电极处进行治疗。
为了补偿发生电流漏泄的可能性，控制单元可被配置成通过“补偿”阻抗测量而考虑发生电流漏泄的可能性。在图53中示出了说明性的控制单元110。说明性的控制单元110可包括输入/输出块5400，用于将控制单元110电连接至体内医疗器械，如导管装置120。控制单元还可包括被通信耦合至输入/输出块5400的控制器5402。存储器5404可被耦合至控制器5402，如图所示。存储器5404可存储程序代码、数据(例如，查找表或类似物)和/或任何其它临时或永久的信息。特定的补偿过程可能取决于特定的医疗器械110。在一个实例中，控制单元110可与各种不同的导管装置120，如具有不同大小和/或数量的二分体的导管装置一起使用。
在一些情况下，该过程可能包括在导管装置120所选的电极片(例如，指定的电极，其在该实例中可能是远端电极片5050)进行阻抗测量，且如果阻抗测量落在预选的值的范围中，则可认为补偿是不必要的。在补偿可能是适当的情况下，所测量的阻抗的范围可以是约300-1000欧姆、约400-900欧姆、约500-850欧姆或在任何其他合适的范围中。在所选范围以下的阻抗(例如，在500欧姆以下)可被认为是对应于其中的电极片与肾动脉的壁“不相接触”的情况。同样地，在所选范围以上的阻抗(例如，在850欧姆以上)可被认为是对应于其中的电极片与肾动脉充分接触的情况。作为参考，血液的阻抗为约570欧姆。如果所测量的阻抗落在所选的范围中，控制单元可计算阻抗补偿值并相应地调整电极片的所测量的阻抗。在一些情况下，不进行与这种阻抗范围的比较，且不管结果怎样均进行补偿。
为了更清楚地理解阻抗补偿计算，可考虑的第一个模型包括二分体5040，其在远端电极片5050上具有第一对双极电极且在近端电极片5070上具有第二对双极电极。所需测量的阻抗可以是在远端电极片5050的双极电极之间的阻抗。该阻抗可被指定为Z1。在远端电极片5050的双极电极的有源电极和近端电极片5070的双极电极的共用接地电极之间可能会发生漏泄。该漏泄阻抗可被指定为Z12。在远端电极片5050通过控制单元所测量的阻抗可被指定为所测量的阻抗MZ1。可以理解的是，所测量的阻抗MZ1可表示阻抗Z1和Z12的组合。由于这些阻抗Z1和Z12可并联运行，因此所测量的阻抗MZ1可由下列方程表示出来：
(1/MZ1)＝(1/Z1)+(1/Z12)方程(1)
通过实验，已确定阻抗Z12可根据下列方程而与在近端电极片5070所测量的测量阻抗MZ2相关联(即，成比例)：
Z12＝kMZ2方程(2)
其中，k为常数。
这种关系可被代入方程(1)并按如下方式求解Z1
Z1＝(MZ1)(kMZ2)/(kMZ2-MZ1)方程(3)
其中：
MZ1为在远端电极片5050的双极电极之间所测量的阻抗；以及
MZ2为在近端电极片5070的双极电极之间所测量的阻抗。
如所看到的，所测量的阻抗MZ1可使用该线性方程(3)进行补偿以给出针对在远端电极片5050上的双极电极之间的实际阻抗Z1的更好的概算。虽然在此处示出了线性方程，但也可考虑使用非线性函数。在某种情况下，线性和/或非线性函数也可以是所施加的温度和电压信号的函数，从而根据需要获得阻抗测量MZ1和/或MZ2和/或任何其他合适的参数。
在已知k的值后，可求解方程(3)。可以理解的是，k的值可能依赖一些因素，包括例如球囊的大小、电极/二分体的数量等而发生变化。在使用外径为4或5mm的球囊的一个实例医疗器械中，k的值可位于约2.0-4.0或约2.5-3.5或约3.0的范围中。
在一些情况下，常数k的值可能取决于所测量的阻抗值MZ1和/或MZ2。例如，常数k可以是所测量的阻抗值MZ2的一个函数，如下所示：
k＝f(MZ2)方程(4)
在另一个实例中，常数k可以是所测量的阻抗值MZ1和MZ2的一个函数，如下所示：
k＝f(MZ1,MZ2)方程(5)
在该实例中，控制单元可包括存储有查找表的存储器，其中所测量的阻抗值MZ1和/或MZ2可用于编入查找表的索引中以找到用于常数k的适当的值。
在一些情况下，可使用两个不同的常数k1和k2。在该实例中，阻抗Z1可被表示为：
Z1＝(k1MZ1)(k2MZ2)/(k2MZ2-k1MZ1)方程(6)
在上述的实例中，可利用控制单元进行这些计算并在必要时调整或补偿所测量的阻抗MZ1，从而更精确地确定相应的电极片的阻抗Z1，且因此确定所给定的电极片是否适合地与表面，如肾动脉相接触以允许进行有效的治疗。
可以理解的是，当对近端电极片5070进行激发时可利用类似的补偿计算(例如，其中所测量的阻抗是由位于在近端电极片5070上的双极电极对之间的阻抗Z2和位于近端电极片5070的有源电极和远端电极片5050上的接地电极之间的阻抗Z21所表示的。
在一个实例中，随着球囊的大小和/或二分体的数量的改变，计算可相应地适应这种改变，从而当补偿相应的电极片的所测量的阻抗时，占用一个以上可能的漏泄路径。例如，在包括共有4个二分体(共有8对双极电极)的外径为6-7mm的球囊的实例医疗器械中，漏泄不仅发生在相同的二分体上的电极对之间，还发生在位于球囊的相对侧的二分体上的双极电极对处，特别是在其中这些二分体共享共用接地的情况下。
图52示意性地示出4个实例二分体5140a/5140b/5140c/5140d，其可被布置在球囊的外表面上。在该实例中，二分体5140a和5140c位于球囊的相对侧上。类似地，二分体5140b和5140d位于球囊的相对侧上。二分体5140a/5140b/5140c/5140d中的每一个可包括远端电极片5150a/5150b/5150c/5150d、包括共享的接地迹线的中间尾部5160a/5160b/5160c/5160d和近端电极片5170a/5170b/5170c/5170d。
在一个实例中，可在近端电极片5170b上的双极电极对处测量阻抗。在近端电极对5170b所测量的阻抗MZ1可表示在近端电极片5170b的双极电极之间的阻抗(例如，阻抗Z1)，以及在近端电极片5170b和远端电极片5150b的双极电极之间的阻抗(例如，阻抗Z12)，在球囊的相对侧上的近端电极片5170b和近端电极片5170b的双极电极之间的阻抗(例如，阻抗Z13)和在球囊的相对侧上的近端电极片5170b和远端电极片5150d的双极电极之间的阻抗(例如，阻抗Z14)。由于这些阻抗可以是并联的，因此所测量的阻抗MZ1可由下列方程表示出来：
(1/MZ1)＝1/Z1+1/Z12+1/Z13+1/Z14方程(7)
对于可能的漏泄路径中的每一个而言，已确定阻抗Z12、Z13和Z14可根据下列方程与在相应的电极片5150b、5170b、5150d分别测量的测量阻抗MZ2、MZ3和MZ4相关联起来(即，成比例)：
Z12＝k12MZ2方程(8)
Z13＝k13MZ3方程(9)
Z14＝k14MZ4方程(10)
其中，k12、k13和k14中的每一个均为常数，且其中：
MZ2为在远端电极片5150b测量的阻抗；
MZ3为在近端电极片5170d测量的阻抗；以及
MZ4为在远端电极片5150d测量的阻抗。
这些关系可被代入方程(7)并按如下方式求解Z1
Z1＝(MZ1)(k12MZ2)(k13MZ3)(k14MZ4)/[(k12MZ2)(k13MZ3)(k14MZ4)-(MZ1)(k13MZ3)(k14MZ4)-(MZ1)(k12MZ2)(k14MZ4)-(MZ1)(k12MZ2)(k13MZ3)]方程(11)
如所看到的，所测量的阻抗MZ1可使用该线性方程进行补偿以给出针对在近端电极片5170b的双极电极之间的实际阻抗Z1的更好的概算。虽然在此处示出了线性方程，但也可考虑使用非线性函数。在某种情况下，线性和/或非线性函数也可以是所施加的温度和电压信号的函数，从而根据需要获得阻抗测量MZ1、MZ2、MZ3、MZ4和/或任何其他合适的参数。
当已知k12、k13和k14的值，则可完成求解方程(11)。在外径为6-7mm的实例医疗器械中，已通过实验确定了k12、k13和k14的值。例如，k12可在约2.5-4.5，或约3-4或约3.5的范围中；k13可在约4.0-6.0或约4.5-5.5或约5.0的范围中；且k14可在约5-7或约5.5-6.5或约6.0的范围中。因此，这些值可用于求解方程(11)中的Z1。
2012年12月21日提交的美国专利申请号13/725872；2013年1月25日提交的美国专利申请号13/750879；2012年12月21日提交的美国专利申请号13/725843；2012年12月21日提交的美国专利申请号13/725885；2012年12月21日提交的美国专利申请号13/725894；和2012年12月21日提交的美国专利申请号13/725904均通过引用并入本文。
虽然已通过实例和为了清楚地进行理解而按某种详细度描述了示例性实施例，但本领域的技术人员将认识到也可采用各种修改、改变和变化。

Claims (15)

1.一种用于确定在体内医疗器械的第一电极片和第二电极片之间漏电的控制单元，其中所述第一电极片与所述第二电极片相间隔，且其中所述第一电极片具有有源电极和间隔的接地电极，且所述第二电极片具有有源电极和接地电极，其中所述第一电极片的所述接地电极被电连接至所述第二电极片的所述接地电极，所述控制单元包括：
用于将所述控制单元电连接至所述体内医疗器械的输入/输出块；
通信地耦合至所述输入/输出块的控制器，所述控制器被编程为：
经所述输入/输出块将第一信号施加至所述体内医疗器械的所述第一电极片的所述有源电极，且作为响应，确定与位于所述第一电极片的所述有源电极和所述第一电极片的所述接地电极之间的阻抗相关的度量；
经所述输入/输出块将第二信号施加至所述体内医疗器械的所述第二电极片的所述有源电极，且作为响应，确定与位于所述第二电极片的所述有源电极和所述第二电极片的所述接地电极之间的阻抗相关的度量；以及
使用与位于所述第二电极片的所述有源电极和所述第二电极片的所述接地电极之间的所述阻抗相关的所述度量确定在所述第一电极片的所述有源电极和所述第二电极片的所述接地电极之间的所述漏电的估计值。
2.根据权利要求1所述的控制单元，其中所述控制器还被编程为基于在所述第一电极片的所述有源电极和所述第二电极片的所述接地电极之间的所述漏电的所述估计值补偿与位于所述第一电极片的所述有源电极和所述第一电极片的所述接地电极之间的阻抗相关的所述度量。
3.根据权利要求1所述的控制单元，其中：
所述第一电极片具有与第一有源电极迹线连接在一起的两个以上有源电极以及与第一接地电极迹线连接在一起的两个以上间隔的接地电极；
所述第二电极片具有与第二有源电极迹线连接在一起的两个以上有源电极以及与第二接地电极迹线连接在一起的两个以上间隔的接地电极；
其中所述第一接地电极迹线被电连接所述第二接地电极迹线以形成共用接地电极迹线；以及
其中所述控制单元的所述输入/输出块将所述控制单元电连接至所述第一有源电极迹线、所述第二有源电极迹线以及所述共用接地电极迹线。
4.根据权利要求1所述的控制单元，其中所述体内医疗器械还包括与所述第一电极片和所述第二电极片相间隔的第三电极片，且其中所述第三电极片具有有源电极和间隔的接地电极，其中所述第三电极片的所述接地电极被电连接至所述第一电极片的所述接地电极以及所述第二电极片，所述控制单元的所述控制器还被编程为：
经所述输入/输出块将第三信号施加至所述体内医疗器械的所述第三电极片的所述有源电极，且作为响应，确定与位于所述第三电极片的所述有源电极和所述第三电极片的所述接地电极之间的阻抗相关的度量；以及
使用与位于所述第三电极片的所述有源电极和所述第三电极片的所述接地电极之间的所述阻抗相关的所述度量确定在所述第一电极片的所述有源电极和所述第三电极片的所述接地电极之间的所述漏电的估计值。
5.根据权利要求1所述的控制单元，其中所述控制器通过将常数和与位于所述第二电极片的所述有源电极和所述第二电极片的所述接地电极之间的所述阻抗相关的所述度量相乘确定在所述第一电极片的所述有源电极和所述第二电极片的所述接地电极之间的所述漏电的所述估计值。
6.根据权利要求5所述的控制单元，其中所述常数是由经验数据确定的。
7.根据权利要求1所述的控制单元，其中所述控制器通过在线性函数中使用与位于所述第二电极片的所述有源电极和所述第二电极片的所述接地电极之间的所述阻抗相关的所述度量确定在所述第一电极片的所述有源电极和所述第二电极片的所述接地电极之间的所述漏电的所述估计值。
8.根据权利要求1所述的控制单元，其中所述控制器通过在非线性函数中使用与位于所述第二电极片的所述有源电极和所述第二电极片的所述接地电极之间的所述阻抗相关的所述度量确定在所述第一电极片的所述有源电极和所述第二电极片的所述接地电极之间的所述漏电的所述估计值。
9.根据权利要求8所述的控制单元，其中所述非线性函数取决于所施加信号的温度和电压中的一个或多个。
10.根据权利要求1所述的控制单元，其中所述控制器被编程为在经所述输入/输出块将所述信号施加至所述体内医疗器械的所述第二电极片的所述有源电极之前或之后，经所述输入/输出块将所述信号施加至所述体内医疗器械的所述第一电极片的所述有源电极。
11.根据权利要求1所述的控制单元，其中所述控制器被编程为在经所述输入/输出块将所述信号施加至所述体内医疗器械的所述第二电极片的所述有源电极的同时，经所述输入/输出块将所述信号施加至所述体内医疗器械的所述第一电极片的所述有源电极。
12.一种用于确定在体内医疗器械的第一电极片和第二电极片之间漏电的方法，其中所述第一电极片与所述第二电极片相间隔，且其中所述第一电极片具有有源电极和间隔的接地电极，且所述第二电极片具有有源电极和接地电极，其中所述第一电极片的所述接地电极被电连接至所述第二电极片的所述接地电极，所述方法包括：
将第一信号施加至所述体内医疗器械的所述第一电极片的所述有源电极，且作为响应，确定与位于所述第一电极片的所述有源电极和所述第一电极片的所述接地电极之间的阻抗相关的度量；
将第二信号施加至所述体内医疗器械的所述第二电极片的所述有源电极，且作为响应，确定与位于所述第二电极片的所述有源电极和所述第二电极片的所述接地电极之间的阻抗相关的度量；
使用与位于所述第二电极片的所述有源电极和所述第二电极片的所述接地电极之间的所述阻抗相关的所述度量确定在所述第一电极片的所述有源电极和所述第二电极片的所述接地电极之间的所述漏电的估计值。
基于在所述第一电极片的所述有源电极和所述第二电极片的所述接地电极之间的所述漏电的所述估计值补偿与位于所述第一电极片的所述有源电极和所述第一电极片的所述接地电极之间的阻抗相关的所述度量。
13.一种系统，其包括：
体内医疗器械，其具有第一电极片和第二电极片，其中所述第一电极片与所述第二电极片相间隔，且其中所述第一电极片具有有源电极和间隔的接地电极，且所述第二电极片具有有源电极和接地电极，其中所述第一电极片的所述接地电极被电连接至所述第二电极片的所述接地电极：
被耦合至所述体内医疗器械的控制单元，所述控制单元被编程为：
将第一信号施加至所述体内医疗器械的所述第一电极片的所述有源电极，且作为响应，确定与位于所述第一电极片的所述有源电极和所述第一电极片的所述接地电极之间的阻抗相关的度量；
将第二信号施加至所述体内医疗器械的所述第二电极片的所述有源电极，且作为响应，确定与位于所述第二电极片的所述有源电极和所述第二电极片的所述接地电极之间的阻抗相关的度量；
使用与位于所述第二电极片的所述有源电极和所述第二电极片的所述接地电极之间的所述阻抗相关的所述度量确定在所述第一电极片的所述有源电极和所述第二电极片的所述接地电极之间的漏电的估计值；以及
基于在所述第一电极片的所述有源电极和所述第二电极片的所述接地电极之间的所述漏电的所述估计值补偿与位于所述第一电极片的所述有源电极和所述第一电极片的所述接地电极之间的阻抗相关的所述度量。
14.根据权利要求13所述的系统，其中：
所述体内医疗器械的所述第一电极片具有与第一有源电极迹线连接在一起的两个以上有源电极以及与第一接地电极迹线连接在一起的两个以上间隔的接地电极；
所述体内医疗器械的所述第二电极片具有与第二有源电极迹线连接在一起的两个以上有源电极以及与第二接地电极迹线连接在一起的两个以上间隔的接地电极；
其中所述第一接地电极迹线被电连接至所述第二接地电极迹线以形成共用接地电极迹线；以及
其中所述控制单元被电连接至所述第一有源电极迹线、所述第二有源电极迹线以及所述共用接地电极迹线。
15.根据权利要求13所述的系统，其中所述体内医疗器械还包括与所述第一电极片和所述第二电极片相间隔的第三电极片，且其中所述第三电极片具有有源电极和间隔的接地电极，其中所述第三电极片的所述接地电极被电连接至所述第一电极片的所述接地电极以及所述第二电极片，且所述控制单元还被编程为：
将第三信号施加至所述体内医疗器械的所述第三电极片的所述有源电极，且作为响应，确定与位于所述第三电极片的所述有源电极和所述第三电极片的所述接地电极之间的阻抗相关的度量；以及
使用与位于所述第三电极片的所述有源电极和所述第三电极片的所述接地电极之间的所述阻抗相关的所述度量确定在所述第一电极片的所述有源电极和所述第三电极片的所述接地电极之间的所述漏电的估计值。
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