CN105056408A - 用于热诱导的肾神经调制的方法和系统 - Google Patents

用于热诱导的肾神经调制的方法和系统 Download PDF

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Publication number
CN105056408A
CN105056408A CN201510342199.0A CN201510342199A CN105056408A CN 105056408 A CN105056408 A CN 105056408A CN 201510342199 A CN201510342199 A CN 201510342199A CN 105056408 A CN105056408 A CN 105056408A
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Prior art keywords
electrode
heat
neuromodulation
setting element
temperature
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CN201510342199.0A
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CN105056408B (zh
Inventor
丹尼斯·扎伦斯
尼古拉斯·扎德尼
本杰明·J·克拉克
埃里克·塔尔
安德鲁·吴
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Medtronic Ardian Luxembourg SARL
Medtronic Ardian LLC
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Ardian Inc
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Priority claimed from US11/504,117 external-priority patent/US7617005B2/en
Priority claimed from US11/599,723 external-priority patent/US20070135875A1/en
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Abstract

本发明提供用于热诱导的肾神经调制的方法和系统。热诱导的肾神经调制可以通过直接和/或通过间接施加热能以加热或冷却对肾功能起作用的神经纤维，或供给或灌注所述神经纤维的血管结构的神经纤维而实现。在一些实施方案中，非靶组织的神经纤维或热能递送元件的参数，可以通过一个或多个用于控制热诱导的神经调制的传感器而监控。在一些实施方案中，可以提供保护元件以减少在非靶组织中诱导的热损伤的程度。在一些实施方案中，热诱导的肾神经调制通过递送脉冲热治疗而实现。

Description

用于热诱导的肾神经调制的方法和系统
本申请是国际申请号PCT/US2007/072396，国际申请日2007年6月28日，中国申请号200780031879.4，发明名称为“用于热诱导的肾神经调制的方法和系统”的分案申请。
对相关申请的参考
本申请要求下列未决美国专利申请的权益：
(a)美国临时专利申请号60/880,340，2007年1月12日提交；和
(b)美国临时专利申请号60/816,999，2006年6月28日提交。
本申请是下列同时待审美国专利申请的每一个的部分继续申请：
(a)美国专利申请号11/599,723，2006年11月14日提交；
(b)美国专利申请号11/504,117，2006年8月14日提交；和
(c)美国专利申请号11/189,563，2005年7月25日提交，其是下列美国专利申请号的美国专利的部分继续申请：(a)2005年5月13日提交的11/129,765，其要求下列美国临时专利申请号的权益：2004年10月5日提交的60/616,254，和2004年11月2日提交的60/624,793；(b)2004年7月28日提交的10/900,199，目前是美国专利号6,978,174，和(c)2003年4月8日提交的10/408,665，目前是美国专利号7,162,303。
全部这些申请都通过引用完全结合于本申请。
通过引用结合
所有在本说明书中提及的出版物和专利申请都如同每个单个出版物或专利申请专门地和单独地指示通过引用结合一样通过引用同等程度地结合于此。
技术领域
本发明涉及神经调制的方法和系统。更具体而言，本发明涉及经由涉及热的加热和/或冷却用于实现肾神经调制的方法和系统。
背景技术
充血性心力衰竭(“CHF”)是典型地由心脏的结构或功能障碍引起的病症，并且可以损害心脏供应自身或泵送足够量的血液通过身体(例如，肾)的能力。已经在动物模型中确定了，心力衰竭病症可以导致异常高的肾交感神经活化，其导致从身体除去的水减少，除去的钠减少，并增加肾素的分泌。增加的肾素分泌导致供应肾的血管的血管收缩，其引起肾血流量降低。从而，肾对于心力衰竭的反应可以使心力衰竭病症的螺旋下降延长。此外，肾还在慢性肾衰竭(“CRF”)、晚期肾病(“ESRD”)、高血压(病理性高血压)及其它肾或心肾病的进展中还起显著的作用。
交感肾神经活性减少，(例如，经由去神经)，可以逆转这些过程。阿迪安(Ardian)公司已经开发了通过将电场施加到促进肾功能的神经纤维而用于治疗肾疾病的方法和系统。见，例如，阿迪安(Ardian)公司的共同拥有和共同未决的美国专利申请号(a)2005年5月13日提交的11/129,765，(b)2005年7月25日提交的11/189,563，和(c)2006年2月27日提交的11/363,867，将其全部通过参考整体结合于本文。电场可以经由去神经引发肾神经调制，所述去神经由不可逆电穿孔、电融合、细胞凋亡、坏死、消融、热变、基因表达改变或另一种适合的模态所引起。可以从定位在血管内的、血管外的、血管内到血管外的装置或其组合而传送电场。例如在共同拥有的美国专利号7,162,303和6,978,174中描述了经由局部药物递送(例如，通过药物泵或输注导管)，刺激电场的使用，及其它模态用于实现肾神经调制的另外的方法和装置，将所述美国专利都通过参考全部结合于此。
虽然这些应用提供有希望的方法和系统，但是数种用于增强这些方法和系统实施的改善将是合乎需要的。
附图简述
图1是图解人肾解剖学的示意图。
图2是显示肾神经相对于肾动脉的位置的示意性等比例的详细视图。
图3A是根据所公开内容的一个实施方案配置的控制热诱导(thermalinduce)的肾神经调制的系统的等比例视图。
图3B是示意性侧视图，部分地以截面方式，图解用于热诱导的肾神经调制的血管外系统的实施方案。
图4A和4B是图解几种类型的热诱导的肾神经调制的示意图，所述热诱导的肾神经调制可以用本文所描述的系统和方法实现。
图5A-5C是示意性侧视图，部分以截面方式，图解根据所公开内容的实施方案配置的热诱导的肾神经调制的血管内装置。
图6A和6B是示意性侧视图，部分以截面方式，图解具有一个或多个壁接触电极的血管内装置的另一个实施方案。
图7A和7B是示意性侧视图，部分以截面方式，图解具有壁接触电极的血管内装置的另一个实施方案。
图8A和8B是示意性侧视图，部分以截面方式，图解具有多个壁接触电极的血管内装置的另一个实施方案。
图9A-9F是示意性侧视图，部分以截面方式，图解包括一个或多个壁接触电极的血管内系统的更进一步的实施方案，以及任选的血流阻塞特征和/或传热流体(thermalfluid)注射功能。
图9G-9N是示意性侧视图，部分以截面方式，图解用于热诱导的肾神经调制的探针的实施方案。
图10是示意性侧视图，部分以截面方式，图解根据所公开内容的实施方案配置的热诱导的肾神经调制的血管内到血管外的系统的实施例。
图11是示意性侧视图，部分以截面方式，图解经由热能的施加用于热诱导的肾神经调制而配置的装置的实施方案。
图12是示意性侧视图，部分以截面方式，图解用于热诱导的肾神经调制的装置的实施方案，所述装置包括适于将热能施加到靶神经纤维的热电元件。
图13是示意性侧视图，部分以截面方式，图解用于热诱导的肾神经调制的装置的另一个实施方案，所述装置包括热电元件。
图14A和14B是示意性侧视图，部分以截面方式，图解经由高强度聚焦的超声波用于热诱导的肾神经调制的装置的实施方案。
图15是示意性侧视图，部分以截面方式，图解图14A和14B的装置的备选实施方案。
图16是图解用于控制热诱导的肾神经调制的能量递送过程的方法的流程图。
图17是图解用于控制热诱导的肾神经调制的计算系统软件模块的方框图。
图18是图解适合于在图17的计算机系统中使用的处理模块的方框图。
图19是功率随时间变化的图，其显示对执行图16的方法的响应的实施例。
详述
A.综述
本发明公开内容提供经由传热加热(thermalheating)和/或传热冷却(thermalcooling)机制的用于控制肾神经调制的方法和系统。这样的方法和系统的许多实施方案可以减少肾交感神经活性。热诱导的神经调制可以经由定位在邻近靶神经纤维位置上的装置通过加热或冷却与肾神经活性有关的结构而实现。例如，这样的装置可以以下列方式定位：(a)在肾血管系统之内(即，血管内定位)，(b)血管外，(c)血管内到血管外，或(d)其组合。热诱导的神经调制可以通过经由加热或冷却而将热应力施加到神经结构以影响或改变这些结构而实现。另外地或备选地，热神经调制可能至少部分地由于灌注靶神经纤维或周围组织的血管结构诸如动脉、微动脉、毛细管、或静脉的改变。
如本文所用，用于神经调制的传热加热机制包括热消融和非消融的热变或损伤(例如，经由持续的加热或电阻加热)。传热加热机构可以包括将靶神经纤维的温度升高超过所需阈值以实现非消融的热变，或超过更高的温度以实现消融的热变。例如，靶温度可以在体温(例如，大约37℃)以上，但是小于用于非消融的热变的约45℃，或所述靶温度可以在大约45℃或更高，以用于消融的热变。
如本文所用，用于神经调制的传热冷却机制包括神经传导的非冷冻热力延缓和/或非冷冻的热神经改变，以及冷冻的热神经改变。传热冷却机制可以包括将靶神经纤维的温度减少到所需阈值以下，例如，在约37℃的体温以下(例如，在约20℃以下)以实现非冷冻的热变。传热冷却机制还可以包括将靶神经纤维的温度减少到例如约0℃以下，以实现冷冻热变。
除在热神经调制期间监控或控制温度之外，可以指定暴露于热刺激的时间长度(length)以影响热神经调制功效的范围或程度。在许多实施方案中，暴露于热刺激的时间长度长于瞬时暴露。例如，暴露延续时间可以短至约5秒钟，或可以更长，诸如约30秒，或乃至长于2分钟。在某些具体的实施方案中，所述暴露时间可以小于10分钟，但是这决不应当被理解为暴露时间的上限。在其它实施方案中，所述暴露可以是间歇的或连续的以实现所需结果。以小时、天或更长方式测量的暴露时间可以用于实现所需的热神经调制。
当通过传热机制进行神经调制时，在前论述的温度阈值可以确定为暴露于热刺激的延续时间的函数。另外地或备选地，所述暴露时间长度可以确定为所需温度阈值的函数。可以指定或计算这些及其它参数以实现和控制所需的热神经调制。
在一些实施方案中，热诱导的肾神经调制可以通过将传热冷却或加热的能量直接和/或间接施加到靶神经纤维而实现。例如，可以将冷却的或加热的流体至少邻近于靶神经纤维施用，或可以将加热的或冷却的元件(例如，热电元件或电阻加热元件)放在所述神经纤维附近。在其它实施方案中，热诱导的肾神经调制可以通过将热能产生和/或施加到靶神经纤维而实现，诸如通过将“热”能量场施加到所述靶神经纤维来实现，所述“热”能量场包括，电磁能、射频、超声波(包括高强度聚焦超声波)、微波、光能(包括激光、红外线和近红外线)等。例如，热诱导的肾神经调制可以通过将脉冲的或连续的热能场递送到靶神经纤维而实现。所述能量场可以是足够的幅度和/或持续时间以热诱导靶纤维中的神经调制(例如，加热纤维或热消融纤维或使所述纤维坏死)。如本文所描述，另外的和/或备选的方法和系统也可以用于热诱导肾神经调制。
当利用用于热神经调制的传热加热机制时，保护性冷却元件诸如传导的或对流冷却的元件，视情况可以用于保护平滑肌细胞或其它非靶组织免于在热诱导的肾神经调制期间的不希望的热效应。同样地，当利用传热冷却机制时，保护性加热元件，诸如传导的或对流的加热元件，可以用于保护所述非靶组织。另外地或备选地，可以通过在靶神经纤维上聚焦传热加热或冷却能量保护非靶组织，以便在所述靶区域以外的热能强度不足以诱导非靶组织中不希望的热效应。当通过血管内递送的热能实现热神经调制时，可以通过将血流用作运走过量热能(热的或冷的)的传导的和/或对流的散热装置(heatsink)来保护所述非靶组织。例如，当血流不被阻塞时，循环血液可以在所述过程期间从非靶组织除去过量热能。血管内递送的热能可以加热或冷却位于邻近血管位置上的靶神经纤维而调制靶神经纤维，同时在所述血管内的血流保护血管壁的非靶组织免受热能影响。例如，热能可以靶定外膜内的神经纤维以使靶纤维坏死或消融，并且所述血流可以保护血管壁中的组织。
在血流存在下使用连续的血管内递送的热能治疗以实现所需的血管内诱导的神经调制的一个缺点是，所述治疗的可行的热量级别(例如，功率)和/或持续时间可能被限制或是不足的。这可能由流经血管的血液的有限热容而引起，以便从血管壁除去过量热能，以减轻对于非靶组织的损伤或坏死。与连续的热能治疗相比，脉冲RF电场或其它类型的脉冲热能可以促成更大的热量级别(magnitude)(例如，更高的功率)，更长的总持续时间和/或更好的受控的血管内肾神经调制治疗。例如，脉冲热治疗可以允许在脉冲之间的间隔期间监控靶或非靶组织上的治疗效果。任选地，该监控数据可以在反馈回路中使用以更好地控制治疗，例如，以确定是否继续或停止治疗，并且它可以促进更高功率或更长持续时间的治疗的受控递送。
而且，与施加同等级别或持续时间的连续热能相比，热能脉冲递送之间的时间间隔可以促进血管壁的非靶组织的另外的对流或其它的冷却。这可以发生，因为通过血管的血流可以对流冷却(加热)血管壁的非靶组织。
当提供脉冲热治疗时，在血管壁组织和相对远的靶神经纤维之间的传热速率的这种差异可以用于消融、发生坏死、或以另外方式调制靶神经纤维，而不会不合需要地影响所述非靶组织。相比于连续的热治疗，可以以更大的热量级别和/或更长的总持续时间(即，在治疗之内的全部热能脉冲的累积持续时间)应用脉冲热能治疗。在热能脉冲之间的休止时间或低能量间隔期间从血管壁到血液的传热传递(或反之亦然)在对于非靶组织中等损害的情况下促进更大的量级。例如，递增的热量级别(例如，更高功率)可以导致增加的加热速率，并且因此导致更有效的热神经调制(例如，影响远离腔壁的神经的能力)。
另外，或作为备选方案，利用患者的血液作为散热装置以建立传热速率中的差异，传热流体(热的或冷的)可以被注射、输注或以另外方式递送到血管中以除去过量热能并且保护非靶组织。例如，所述传热流体可以包括加热的、冷却的或在室温的盐水或其它生物相容的流体。例如，所述传热流体可以通过所述设备(device)或通过引导导管注入，所述设备或引导导管在能量递送元件位置上游或在相对于寻求保护的组织的其它位置。所述传热流体可以在血流存在下或在流动暂时被阻塞的情况下注入。
流动的阻塞与传热流体递送结合可以促进对非靶组织中传热动力学的控制的改善。例如，患者之间血流速率的正常可变性，其将改变血流的传热能力，可以通过在血管壁和以受控速率递送的传热流体之间传递热能而被控制。使用注入的传热流体从非靶组织除去过量热能以在靶组织的治疗处理期间相对保护非靶组织，可以在除血管以外的体腔中使用。
在一些实施方案中，可以提供用于实时监控被靶神经纤维支配的组织中神经调制或去神经和/或非靶组织中热损伤的范围或程度(例如，热变的范围或程度)的方法和装置。同样地，可以提供热能递送元件的实时监控。例如，这样的方法和装置可以包括用于测量受监控的组织的温度或热能递送元件温度的热电偶或其它温度传感器。可以测量的其它参数包括功率、递送的总能量、神经活性或阻抗。监控数据可以用于所述热治疗的反馈控制。例如，可以通过沿着治疗区域附近的血管壁获得温度或阻抗测量，和/或通过限制治疗的功率或持续时间，监控和控制血管内递送的热治疗。
为了更好理解如下所述装置的数个实施方案的结构以及使用这样的装置用于热诱导的肾神经调制的方法，提供人的肾解剖学描述。
B.肾解剖学概述
如图1所示，人肾解剖学包括肾K，其通过肾动脉RA被供给氧合的血液。经由腹部的主动脉AA将肾动脉连接到心脏。脱氧的血液经由肾静脉RV和下腔静脉IVC从肾流到心脏。
图2更详细地图解肾解剖学的一部分。更具体而言，肾解剖学也包括沿着肾动脉RA的纵向尺寸L纵向延伸的肾神经RN。例如，肾神经RN一般在所述动脉的外膜内。肾动脉RA具有在动脉的倾斜轴θ周围围绕动脉圆周和螺旋的平滑肌细胞SMC。肾动脉的平滑肌细胞因此具有横断于(即，非平行的)肾动脉的纵向尺寸的纵长或更长的尺寸。肾神经和平滑肌细胞的纵向尺寸的错排定义为“细胞错排”。
C.用于热诱导的肾神经调制的系统和方法的实施方案
图3A-19图解用于热诱导的肾神经调制的系统和方法的实施例。例如，图3A是根据所公开内容的实施方案配置的用于控制患者101的热诱导的肾神经调制的系统100的等比例视图。系统100可以包括处理器114，电连接到处理器114的场发生器110，和操作连接到所述场发生器110的探针104。在图解的实施方案中，电缆112将探针104电连接到场发生器110。在其它的实施方案中，处理器114，探针104，和/或场发生器110可以经由例如射频信号无线连接。
处理器114可以是任何一般用途的、可编程的数字计算设备，其包括，例如，个人电脑，可编程逻辑控制器，分布式控制系统，或其它计算设备。处理器114可以包括中央处理单元(CPU)，随机存取存贮器(RAM)，非易失性次级存储器(例如，硬盘驱动器，软盘驱动器，和CD-ROM驱动器)，和网络接口(例如，有线的或无线的以太网卡和数字的和/或模拟的输入/输出卡)。程序代码和数据可以从所述非易失性次级存储器装载到RAM并提供到CPU用于执行。CPU可以产生用于显示、输出、传输或存储的结果。
所述场发生器110可以产生电、射频、超声波(包括高强度聚焦超声波)、微波、激光或其它类型的信号，所述信号的所需参数足以热诱导或以其它方式诱导靶神经纤维中的肾神经调制。例如，场发生器110可以产生具有所需频率、振幅、和功率水平的电信号，并且电缆112可以将产生的信号传递到探针104。处理器114与场发生器110连通以控制场发生器110的功率输出，用于将所需量的能量提供到靶神经结构。在图解的实施方案中，场发生器110位于患者101外部。然而，在其它实施方案中，所述场发生器110可以在所述患者内内部定位。
探针104可以是在CT、X射线照相的、或另一种适合的引导模式下的腹腔镜检查探针、经皮探针、血管内导管、或另一个适合的设备，其配置用于沿着肾动脉、肾静脉、脐点、和/或格罗塔筋膜和/或在肾动脉、肾静脉、脐点、和/或格罗塔筋膜中邻近于肾神经供应的轨迹插入。探针104可以包括至少一个用于递送热能场治疗的电极108和经由电缆112连接到场发生器110的电连接器106，用于将热能场递送到所述电极108。在一些实施方案中，探针104可以包括用于将热能场递送到电极108的集成电缆(未显示)，并且电连接器106可以被省略。在图解的实施方案中，例如，探针104是配置成经皮推进到邻近患者101的解剖靶102(例如，肾动脉或肾静脉)的经皮探针，如下面对于图3B所更详细地描述。在其它实施方案中，所述探针104可以是可植入的设备。
电极108可以是相互电独立的单独电极，具有共同连接的接触的分段电极，或连续电极。例如，分段电极可以通过提供安装到所述电极上的有槽管或通过电连接一系列单独电极而形成。单独电极或电极的组108可以配置成提供双极信号。电极108可以是动态可分配的以促进任何电极之间和/或任何电极和远程电极之间的单极和/或双极能量递送。例如，远程电极可以外部连接到患者皮肤(例如，到患者的腿或胁腹)。
探针104还可以包括至少一个传感器(未显示)，用于测量患者101的生理学参数。例如，探针104可以包括温度传感器、阻抗传感器、超声波传感器、和/或其它类型的传感器。所述传感器可以测量生理学参数(例如，温度)并且将测量的生理学参数传输到处理器114用于处理。
任意的，所述系统100还可以包括操作性地连接到处理器114的输入设备118，输出设备120，和/或控制面板122。输入设备118可以包括键盘、鼠标、触摸屏、按钮、开关、电势差计、和任何其它适于接收使用者输入的设备。所述输出设备120可以包括显示屏，打印机，介质阅读器，音频设备，和适于提供使用者反馈的任何其它设备。控制面板122可以包括指示器灯、数字显示器、和音频设备。在图3A中显示的实施方案中，具有轮126的支架(rack)124携带处理器114，场发生器110，输入设备118，和输出设备120用于便携性。在另一个实施方案中，多种部件(component)可以合并成单一封装(enclosure)(例如，场发生器110)，例如，用于便携式安装在IV台、IV极、仪器台、输注台、和/或其它的支撑结构上。在另外的实施方案中，可以固定地安装多种部件。
在操作中，操作者可以将探针104至少邻近患者101的体腔(例如肾动脉或肾静脉)的壁放置，然后将能量递送到探针104以实现热肾神经调制，如下更详细地描述。例如，图4A和4B图解可以用这里所描述的系统和方法实现的多种类型的热神经调制。仅为了说明而提供图4A和4B，并且其决不应当被理解为限制性的。
图4A说明由于热暴露产生的热神经调制。如所示，暴露到超过约37℃的体温但是低于约45℃的温度的热可以通过中度加热靶神经纤维或用于灌注所述靶纤维的血管结构而诱导热变。在血管结构被影响的情况下，靶神经纤维排斥灌注，导致神经组织的坏死。例如，这可以在所述纤维或者结构中诱导非消融的热变。暴露到超过约45℃或超过约60℃的温度的热量中可以经由对所述纤维或结构的实质加热而诱导热变。例如，这样的更高温度可以热消融所述靶神经纤维或所述血管结构。在一些患者中，可以合乎需要的是实现热消融靶神经纤维或所述血管结构的温度，所述温度小于约90℃，或小于约85℃，或小于约80℃和/或小于约75℃。不考虑用于诱导热神经调制的热暴露的类型，预期肾交感神经活性(“RSNA”)的减少。
关于图4B，用于神经调制的传热冷却包括神经传导和/或神经改变的非冷冻热延缓，以及冷冻的热神经改变。非冷冻的传热冷却可以包括将所述靶神经纤维或供养所述纤维的血管结构的温度减少到约37℃体温以下或约20℃以下，但是超过约0℃的冷冻温度的温度。该非冷冻的传热冷却可以延缓神经传导或可以导致神经改变。减缓的神经传导可以使用连续或间歇冷却靶神经纤维以维持所需热神经调制，同时神经改变可能仅需要不连续的处理以实现持续的热神经调制。用于神经调制的传热冷却还可以包括冷冻的热神经改变，其通过将靶神经纤维或供养所述纤维的血管结构的温度减少到约0℃的冷冻点以下的温度。不考虑用于诱导热神经调制(冷冻的或非冷冻的)的冷暴露的类型，预期RSNA的减少。
仍参考图3A，操作者和/或处理器114可以监控和控制能量递送过程。如上所述，探针104可以包括测量患者101的生理学参数的传感器。探针104可以将测量参数经由电缆112或无线地传输到处理器114。处理器114可以处理和分析所接收的参数并且将所述参数显示在输出设备120的适当单元上。处理器114可以导致所述系统发出警报声，条件是所接收的参数超过预定阈值并且利用输出设备120和/或控制面板122发出任何警报信号。处理器114还可以分析和处理参数测量数据，用于或者单参数或组合方式的多参数，并且可以将所述数据与存储的非经验数据进行比较以识别可以准许更密切注意的任何模式。处理器114还可以在数据库中存储所接收的参数和数据模式用于随后的检索。另外，处理器114可以调制场发生器110的功率输出，这基于所接收的参数和/或经由输入设备118从操作者接收的输入进行，如下对于图16-19更详细地描述。
在图3B中，探针104已经推进经过经皮进入位置P进入肾动脉RA附近。探针104刺穿患者101的格罗塔筋膜F，并且所述电极108通过探针104并且沿着动脉和筋膜之间的环形空间被推进到位。一旦适当定位，可以经由跨越电极108递送的脉冲的或连续的电场加热靶神经纤维。例如，在图3B中，电极108包含双极电极对，其可以产生热能场109。这样的加热可以对靶神经纤维消融或引起非消融的热变，以至少部分切除受靶神经纤维神经支配的肾的神经。能量场还可以在靶神经纤维中诱导可逆的或不可逆的电穿孔，其可以提供在神经纤维中诱导的热变。在处理以后，可以将探针104从患者除去以终止所述程序。
图5A-9，14，和15图解用于热诱导的肾神经调制的血管内系统和有关方法的数个实施方案。应当理解，在下列实施方案的每一个中的电极可以连接到发生器(例如，场发生器110)，即使所述发生器未在下面明确显示或描述。
例如，图5A和5B是示意性侧视图，其图解用于热诱导的肾神经调制的血管内装置300。装置300可以包括具有任选的定位元件304的导管302、沿着导管302的轴配置的轴电极306a和306b、和任选的在定位元件304的区域中沿着导管302的轴配置的不透射线的标记物308。相对于所述血管和/或神经，定位元件304可以是气囊、可展开的金属线筐(wirebasket)、其它机械展开器，或用于容纳电极306a-b的另一种适合的设备。可以这样安排电极306a-b，以便电极306a接近定位元件304的近端并且电极306b接近定位元件304的远端。电极306a-b电连接到场发生器110(图3A)，用于将能量递送到靶神经纤维。在其它实施方案中，一个或多个电极306a-b可以包含帕尔贴(Peltier)电极用于加热或冷却靶神经纤维以调制所述纤维。
定位元件304可以任意定位或以另外方式驱动电极306a-b与所述腔壁进行接触。例如，当定位元件304是可臌胀的气囊时，如图5A所示，所述气囊可以充当可展开的电极元件306a-b的定中心的和/或展开元件，并且作为阻抗-改变电绝缘器用于引导递送的能量场经由电极306a-b进入或跨越所述血管壁，用于调制靶神经纤维。由定位元件304提供的电绝缘可以减少为实现所需靶纤维调制所必需的施加能量的级别或其它能量场参数，其可以包括部分或完全将含有靶纤维的组织去神经。申请人在前已经描述了2005年11月4日提交的共同未决美国专利申请号11/266,993中的适合的阻抗改变元件的用途，将其通过参考全部结合于此。
而且，定位元件304任选地可以用作冷却元件和/或加热元件。例如，定位元件304可以随着冷却流体膨胀，所述冷却流体用作用于从接触所述元件的组织去除热的散热装置。相反，定位元件304任选地可以是加热元件，通过用温热流体膨胀它，所述温热流体加热和所述元件接触的组织。传热流体任选地可以在定位元件304之内循环和/或交换以促进更有效的传导和/或对流的传热传递。传热流体还可以用于经由传热冷却或加热机制实现热神经调制，如下所更详细所描述。
另外或备选地，定位元件304(或装置300的任何其它部分)可以包含一个或多个用于监控所述过程的传感器。在一个实施方案中，定位元件304具有用于监控靶组织及非靶组织的温度或其它参数的壁接触热电偶310(图5A)，电极，定位元件和/或装置300的任何其它部分。备选地，电极306a和/或306b可以具有一个或多个组合到它们中的热电偶。
图5A和5B中显示的血管内实施方案的电极306a-b可以是单独的电极(即，独立的接触)，具有共同连接接触的分段电极，或单一连续电极。而且，电极306a-b还可以配置成提供双极信号，或电极306a-b可以一起使用或连同单独的患者接地垫独立地用于单极用途。电极306a-b可以附属于定位元件304，以便它们在定位元件304展开时接触动脉壁。例如，电极306a-b可以固定到内表面，外表面，或至少部分埋置在定位元件304的壁之内。描述在下文中的图5C，图解壁接触电极的一个实例，而图6-9图解备选的壁接触电极。
如图5A中所示，以通过引导导管或其它设备的低姿态(lowprofile)递送构造的方式，导管302可以被递送到如所示的肾动脉RA之内的治疗部位，或者可以将它递送到肾静脉或递送到接近于对肾功能起作用的神经组织的任何其它血管。备选地，导管可以定位在多个用于热肾神经调制的血管中，例如，在肾动脉和肾静脉两者之内。在多个血管中用于脉冲电场肾神经调制的技术之前已经描述过，例如，在2006年7月12日提交的共同未决美国专利申请号11/451,728，将其通过参考全部结合于此。
一旦定位元件304是在所述肾血管系统之内的所需位置，则它可以展开成与所述血管的内壁进行接触。然后可以将热能场经由电极306a-b跨越动脉壁递送。所述场沿着对肾功能起作用的神经纤维通过加热热调制所述活性。在数个实施方案中，所述热调制至少部分地将受所述神经纤维支配的肾经由加热去神经。例如，这可以通过靶神经纤维的热消融或非消融的改变而实现。
在图5A中所示的实施方案中，定位元件304是可臌胀的气囊，其可以优先定向如上所述的能量场。在图5B中图解的实施方案中，定位元件304包括可展开的金属线筐，其基本上将电极306a-b定中心在血管之内，而不阻塞经过所述血管的血流。在热能场(或其它热能的)的递送期间，血液可以作为传导的和/或对流的传热传递的散热装置，以从非靶组织除去过量热能。这保护非靶组织免受不希望的热效应。当在能量递送期间不阻塞血流时，诸如在图5B中显示的实施方案中，该效应可以增强。
利用患者的血液作为散热装置预计将促进更长时间或更大级别的热处理以减小递送到非靶组织的不希望的效应的风险，其可以增强在靶神经纤维的治疗功效。虽然图5B中显示的实施方案包括用于在不阻塞流动的情况下将电极306a-b定中心的定位元件304，应该理解所述定位元件304可以被除去和/或所述电极306a-b可以附着于定位元件304，以便它们在定中心元件展开时未处于血管中心。在这样的实施方案中，患者的血液仍然可以减轻过量的传热加热或冷却以保护非靶组织。
在血流存在下使用连续的、血管内递送的热能治疗以实现所需的血管内诱导的神经调制的一个缺点是治疗的可用热量级别(例如，功率)和/或持续时间可能被限制或是不足的。这可以发生，因为血液除去热的能力受到限制，并且因而经过血管流动的血液可能不从血管壁除去足够的过量热能以减轻或避免非靶组织中不合需要的效应。和连续热能治疗对比，脉冲热能治疗诸如脉冲热RF电场的使用可以促进更大的热量级别(例如，更高的功率)，更长的总持续时间，和/或更好控制的血管内肾神经调制治疗。例如，可以在脉冲之间的间隔期间监控靶或非靶组织上的治疗效果。该监控数据任选地可以用于反馈回路以更好控制所述治疗，例如，以确定是否继续或停止治疗，并且它可以促进更高功率或更长持续时间的治疗的受控递送。
而且，与使用同等级别或持续时间的连续热治疗相比，热能脉冲之间的休止时间或低能量间隔可以促进血管壁的非靶组织的另外的对流的或其它冷却。这可以发生，因为经过血管的血流可以比定位在血管壁之外的靶神经纤维更快地对流冷却(加热)血管壁的非靶组织。
当提供脉冲热治疗时，血管壁组织和相对远的靶神经纤维之间的传热速率的差异可以用于消融、坏死、或以其它方式调制靶神经纤维，而不在非靶组织中产生不合需要的效果。结果，与连续热治疗相比，脉冲热能治疗可以以更大的热量级别和/或更长的总持续时间情况下施用(即，全部热能脉冲的累积持续时间)。在所述热能脉冲之间的间隔期间在血管壁的更高的传热速率促进更大的数量/更长的持续时间的递送。
另外地或备选地，利用患者的血液作为散热装置以产生传热速率的差异，传热流体(热的或冷的)可以注入、输注或以其它方式递送到血管中以除去过量热能并保护非靶组织。例如，传热流体可以包括盐水或另一种生物相容的流体，其是加热的、冷却的或是在室温下。例如，可以在能量递送元件上游的位置，或在相对于要保护的组织的其它位置，将传热流体注射经过所述设备或经过引导导管。传热流体可以在血流存在下或在血流暂时阻塞的情况下注入。
在数个实施方案中，与传热流体递送相结合的血流阻塞可以促进对于传热动力学的良好控制。例如，通过在血管壁和以受控速率递送的传热流体之间传递热能，可以控制改变血流传热能力的患者之间血流速率的正常差异性。而且，使用注入传热流体而从非靶组织除去过量热能以便在靶组织的治疗处理期间保护非靶组织的这种方法可以用在除了血管之外的体腔中。
一个或多个传感器，诸如图5A的热电偶310，可用于监控在电极306a-b、血管壁和/或在沿着所述装置或患者解剖学的其它预定位置的温度或其它参数。可以使用测量的参数作为反馈控制热神经调制。例如，该反馈可以用于将所述参数保持在所需阈值以下。例如，所述参数可以保持在可能引起非靶组织中不希望的效果的阈值以下。在血液流经血管的情况下，更多的热能可以被带走，这可以允许比血流在血管中被阻塞时更高的能量治疗。
如前所述，当利用血管内装置以实现热神经调制时，另外地或备选地，将电极中心定位在血管之内，所述电极任选地可以配置成接触血管的内壁。与中心定位的电极相比，壁接触电极可以促进热能场跨越血管壁更有效传递到靶神经纤维。在一些实施方案中，壁接触电极可以以减小的外形构造递送到血管治疗部位，然后在体内展开成展开的构造，其中所述电极接触血管壁。在一些实施方案中，电极的展开至少是部分可逆的以促进电极从患者的血管回收。
例如，图5C是图解具有一个或多个壁接触电极306c的装置400的实施方案的示意性侧视图。可展开筐定位元件304的一个或多个支柱可以包括在除沿着接触血管壁并且形成电极306c的部分以外的区域中是绝缘的传导性材料。电极306c可以以双极或单极构造形式使用。而且，电极306c可以包括一个或多个传感器(未显示)，用于监控和/或控制热能递送的效果。例如，传感器可以是热电偶、阻抗传感器、温度传感器等。
图6A和6B是示意性侧视图，其图解具有配置成接触血管内壁的电极的血管内装置500的另一个实施方案。图6A和6B的装置500不同于图5A和5B的装置300，因为图5A和5B的近端电极306a已经用壁接触电极306a′替换。壁接触电极306a′包括将电极306a′连接到导管302的轴的近端连接器312a并且电连接到场发生器(未显示)。装置500还具有多个延伸314a，其从近端连接器312a伸出，并且至少部分地在定位元件304的表面上展开。任选地，延伸314a可以是选择性绝缘的，以便仅延伸314a的选择部分(例如，所述延伸的远端尖端)是电活性的。任选地，电极306a′和/或连接器312a可以从有槽的管制造，诸如不锈钢或形状记忆(例如，NiTi)有槽管。而且，所述电极的全部或一部分可以是镀金的以改善不透射线性和/或电导率。
如图6A所示，在电极306a′以减小的外形构造定位的情况下，导管302可以经过导线G递送到在患者血管之内的治疗部位。任选地，导管302可以经过引导导管303递送以促进壁接触电极306a′的这种减小的外形递送。当依照要求定位在治疗部位时，通过展开所述定位元件304(如图6B中所示)，电极306a′可以展开成与血管壁接触。然后可以跨越血管壁并且在电极306a′和306b之间递送热双极电场以诱导热神经调制，如上所述。备选地，306a’或306b可以包括单极电极，其中返回电极(未显示)放置在患者的外表面上。任选的定位元件304可以改变血管之内的阻抗并且更有效地给跨越血管壁的电能量定路线到靶神经纤维。
在终止电场以后，电极306a′可以返回到减小的外形并且装置500可以从患者除去或在血管中复位。例如，定位元件304可以折叠(例如，被放气)，并且电极306a′可以通过在引导导管303之内收回导管302而收缩。备选地，电极306a′可以由倾向成为折叠构造的形状记忆材料制造，以便在定位元件304折叠时所述电极自折叠。
虽然图6A和6B中显示的电极306a′展开成与血管壁接触，但是应当理解电极306a′备选地可以由倾向于自展开的材料制造，以便在电极306a′定位在引导导管303远端时，电极306a′自展开成与血管壁接触。在通过所述电极递送电场期间，电极306a’的自展开实施方案可以避免需要定位元件304和/或可以促进经过血管的血流的维持。在电场递送以后，自展开的电极306a′可以返回到减小的外形以促进通过在引导导管303之内收回导管302而将装置300从患者除去。
图7A和7B是示意性侧视图，其图解使用壁接触电极306a″用于递送场的装置600的另一个实施方案。图7A显示减小的外形构造形式的电极306a″，并且图7B显示展开的构造形式的电极306a″，其中电极306a″的传导部分接触血管壁。作为图6A和6B的电极306a′的近端连接器312a的备选方案，图7A和7B的电极306a″包括用于将电极306a″连接到定位元件304的远侧上的导管302的轴的远端连接器316a。远端连接器316a使电极306a″在整个定位元件304上展开并且可以在热神经调制以后促进电极306a″的收缩。例如，在定位元件304的收缩期间或以后，可以通过相对于导管302邻近地缩回引导导管303而收缩电极306a″。备选地，在所述装置近端的金属线可以邻近地缩回以收缩电极306a″。
图8A和8B是示意性侧视图，其图解用于热诱导的神经调制的装置700的又一个实施方案。图8A和8B的装置700包括图6A和6B的近端电极306a′和远端壁接触电极306b′。装置700还分别包括近端和远端定位元件304a和304b，用于分别展开所述近端和远端的壁接触电极306a′和306b′，与所述血管壁进行接触。图8B中显示的实施方案仅包括单一定位元件304，但是远端壁接触电极306b′邻近面对并定位在定位元件304的远端部分上以促进远端电极306b′的展开。在图8B中图解的实施方案中，近端电极306a′和远端电极306b′的延伸任选地可以沿着非传导的连接器318连接以促进治疗后的电极的折叠和回收。
双极电场可以在近端和远端的壁接触电极306a′和306b′之间递送，或单极电场可以在近端电极306a′和/或远端的电极306b′和外部接地之间递送。与近端和远端的电极306a′和306b′中的一个或两个在血管内定中心相比，近端和远端的电极306a′和306b′两者都与血管壁接触可以在递送热能场期间促进跨越所述壁的更有效的能量传递。
图9A-9N是图解血管内系统的另外实施方案的示意性侧视图，其包括一个或多个壁接触电极、血流阻塞特征、和/或传热流体注射功能。如下对于图9A-9N所述的实施方案被描述为单极设备，但是应当理解任何(或全部)实施方案可以作为双极设备配置或运行。而且，虽然血流阻塞和传热流体注射是与壁接触电极结合描述的，但是应当理解这样的阻塞和注射特征可以与不接触血管壁的电极结合的方式提供。
如上所述，另外地或备选地，利用患者的血液作为散热装置而在递送热能所在的血管壁的靶神经纤维和非靶组织之间产生不同的传热速率，可以将传热流体(热的或冷的)注入、输注或以其它方式递送到血管中。传热流体可以进一步地除去过量热能并且保护非靶组织。当通过加热递送热治疗时，例如，传热流体可以包括冷却的或室温的盐水(例如，盐水的温度低于在治疗递送期间的血管壁温度)。可以在能量递送元件上游的位置，或在相对于要保护的组织的其它位置，将传热流体注射经过所述设备导管或经过引导导管。传热流体可以在血流存在的情况下或在血流暂时阻塞的情况下注入。与传热流体递送结合的血流阻塞可以促进对于沿着非靶组织的传热动力学的良好控制，以及来自下游位置的流体注射。
图9A和9B图解装置800，其包括具有定位元件804的导管802，所述定位元件804可用于在血管内定位所述装置和/或阻塞血流。例如，定位元件804可以是可臌胀的气囊。装置800可以进一步包括一个或多个邻近定位元件804定位的活动的单极电极810，以便定位元件804的膨胀阻滞电极组件806下游的血流。电极组件806包括多个延伸814，并且应当理解可以提供任何所需数量的延伸，包括单一延伸。将单极电极810与远程电极组合使用，所述远程电极诸如定位在患者以外的接地垫。装置800还可以包括定位元件804和电极组件806之间的输注端口805。
如图9A中所示，导管802可以以减小的外形递送构造在肾动脉RA之内推进。关于图9B，一旦适当定位在治疗部位，则电极组件806可以活动地展开，或它可以通过从电极810去除鞘、引导导管803、或另一种类型的限制器而自展开。展开的电极组件806接触所述血管壁。定位元件804可以展开(在电极组件806的展开以前、期间或以后)以将电极组件806适当定位在血管之内和/或将血流阻塞在电极组件806下游的肾动脉RA之内。单极电场可以在活动的电极810和外部接地之间递送。备选地，双极电场可以在任何两个电极810之间产生。例如，电场可以包括脉冲的或连续的RF电场，其在靶神经纤维中热诱导神经调制(例如，坏死或消融)。例如，可以通过用可以结合到电极810中的热电偶、阻抗传感器、或其它传感器收集的数据监控和控制所述热治疗。
为了在没有不合需要地影响非靶组织的情况下增加可以被递送的功率或热治疗的持续时间，可以将传热流体输注物(infusate)I经过导管802的注射口805注入以冷却非靶组织。这预计减轻非靶组织中不希望的影响。例如，输注物I可以包括冷却的盐水，其在热治疗期间从血管壁除去过量热能。
相比于在靶神经纤维发生的冷却(或加热)，在非靶血管壁组织和输注物I之间的对流的或其它的传热传递可以以更快的速率促进血管壁的冷却(或加热)。在血管壁和靶神经纤维之间的传热速率的这种差异可以用于调制神经纤维。而且，当利用脉冲热治疗时，在相对于神经纤维的壁处加速的传热传递可以允许比较高的能量或更长的持续时间治疗(与连续热治疗相比)。同样，脉冲之间的间隔可以用于监控和/或控制治疗的作用。
图9C是图解装置820的另一个实施方案的示意性侧视图，所述装置820包括壁接触电极810、流动阻塞、和传热流体注射。在图9C中所示的实施方案中，阻塞元件804被连接到导线G，其可以包括膨胀腔，并且将输注物I经过导管802的远端出口递送。备选地，阻塞元件804可以连接到单独的导管或鞘(未显示)而不是连接到导线G。同样，例如，输注物I可以经过导线腔或经过导管802的另外的腔或环状空间递送。图9D图解装置830的另一个实施方案，其中阻塞元件804定位在电极组件806附近或上游，并且输注物I在远离阻塞元件804但接近电极组件806的位置递送。
图9E是示意性侧视图，其图解具有定位在电极组件806的近端和远端的阻塞元件804(两个显示为阻塞元件804a和804b)的装置840的又一个实施方案。除具有第一注射口805a之外，导管803包括吸入口805b。单独的腔可以经由注射口805a和805b延伸穿过用于输注物I的注射和吸入的导管。提供输注物的注射和吸入促进对于输注物的流动动力学的良好控制，并且因此促进输注物I的传热动力学特性。例如，以相同速率提供吸入和注射可以在血管和电极806之间提供一致的传热动力学特性。
图9F图解具有导管852的装置850的又一个实施方案，其包括可以经由延长构件857移动成与血管壁接触的壁接触电极856。在这个实施方案中，延长构件857在电极856附近远端连接到导管852。延长构件857可以配置成用于自身或机械展开，或它可以延伸通过导管852的端口805并且通过导管的腔延伸到邻近位置用于被医疗专业人员操作。延长构件857的邻近截面可以相对于导管852被医疗专业人员推进，以便构件呈现图解的弯曲外形。
在延长构件展开时，偏转导管852，以致连接到导管轴的电极856接触血管壁。任选地，定位元件804可以展开以促进经由延长构件857定位所述电极856和/或阻塞通过所述血管的流动。定位元件804可以连接到所述引导或递送导管803。如显示，任选地，可以通过导管852递送输注物I。
图9G-9N是图解探针或导管900的实施方案的部分示意性侧视图，所述探针或导管900包括适于用在图3A和3B的系统100中的成型的或自展开的或机械活动的电极。例如，图9G图解用于递送到治疗部位的减小的外形构造形式的探针或导管900，并且图9H图解处于展开的或未压缩状态的探针900的一部分。一起参考图9G和9H，探针900可以包括轴904、电极906、轴904和电极906之间的中间部分(portion)或段(section)908和覆盖并且可释放携带轴904和中间部分908的引导导管或鞘910(例如，5French引导导管)。在递送到治疗部位(图9G)期间，中间部分908可以以压缩状态(即，使弯曲或成型区域基本上是平的或另外被鞘910的内壁变直)搁在鞘910之内。当鞘910缩回时，中间部分908将展开到它的未压缩的拱形的或弯曲的形状(图9H)。中间部分908的弯曲或成型的外形促进电极906和相应的血管壁之间的接触。参考图9J在下面更详细地描述该过程。
同样在图9G的减小的外形构造中可见，轴904和中间部分908可以任选具有内部空间912(未显示)，并且探针900可以进一步包括连接到中间部分908的金属线112(分别表示为112a和112b)。金属线112a-b将电极906电连接到场发生器110并且可以包括热电偶金属线。如下所更详细地论述，电极906可以经由金属线112将由场发生器110供给的电场递送到相应的体腔壁。
一起参考回到图9G和9H，轴904一般可以是由一种或多种生物相容的材料(例如，塑料、金属、合金、和陶瓷)构造的圆柱状管。轴904还可以在轴904的远端部分包括更柔性的区域或段904a，并且配置成允许探针900在使用期间弯曲或扭曲。例如，在电极906递送到治疗部位期间，柔性的区域904a可以允许探针900从主动脉进行相对急剧的转向到肾动脉。在一个实施方案中，所述柔性的区域904a可以包括编织的轴，而没有海波管(hypotube)或其它可以结合到轴904中的支持结构的支持。如图9H中所示，柔性区域904a具有约7cm的长度L1。然而，在其它实施方案中，柔性的区域904a可以具有约2cm至约140cm的长度L1(所述轴904的整个工作长度一般可以是柔性的)。在其它的实施方案中，轴904和/或柔性的区域904a可以具有不同的排列和/或构造。
探针900可以具有约55cm至约140cm的工作长度或有效长度L2。如这里所用，″工作长度″和″有效长度″限定为在患者身体内部安装的探针900的长度(例如，轴904，中间部分908，和电极906)。在其中55cm引导导管用于促进探针900的递送的构造中，工作长度或有效长度可以是约60cm到约80cm。在其中90cm引导导管用于促进探针900的递送的构造中，工作长度或有效长度可以是约95cm到约120cm。例如，在图解的实施方案中，探针900具有约为108cm的工作长度或有效长度L2并且配置成与长度约为90cm的鞘910一起使用。然而，在其它的实施方案中，所述探针900可以具有不同的工作长度L2和/或配置成与具有不同尺寸和/或构造的鞘一起使用。
电极906包括由第一金属(例如，铂或铱)构造的带914和配置在所述带914内部的第二金属916。带914一般可以是圆柱状的或具有另一种适合的形状。第二金属916可以与第一金属相同，或第二金属916可以是不同的金属或金属合金。所述金属线相互电连接。例如，所述金属线可以直接电连接或经由第一和/或第二金属连接。因而，电极906可以将从场发生器110供给的电场经由金属线112a-b递送到体腔壁。在一个备选实施方案中，使用单一金属线而不是一对金属线。
电极906还可以在将电场递送到所述组织时测量温度(经由热电偶或所述热敏电阻，或其它温度传感元件)，阻抗或另一个参数。例如，可以测量供应电场的电压和电流，并且可以根据欧姆定律计算电阻或阻抗。
其中仅测量阻抗的实施方案的一个预期优点是对于探针900仅需要一个金属线。如果探针900包括电连接至所述电极的温度传感器，则必须使用至少一个更多的金属线。在该情况下，总共两个金属线可用于递送能量、测量阻抗和测量温度。如果探针900包括电学上独立于电极的温度传感器，则必须使用至少一个更多的金属线。另外，超过一个温度传感器可以用于进行另外的温度测量。另外的金属线可能增加探针900的尺寸和复杂度并且增加故障的可能性。
虽然图解的电极906包括带914，但是电极906可以具有其它的构造。例如，电极906可以包括由第一金属构造的线圈，其围绕由第二金属构造的核心。具有线圈的一个预期优点是线圈可以减少应力，原因在于当测量温度时的热膨胀。在另一个实施方案中，所述电极可以由单一金属或其它没有所述带的导体组成。
图9I是取自图9H的区域9I的探针900的一部分的放大视图。中间部分908可以包括由不锈钢、镍钛金属互化物、塑料或另一种适合的材料(或其组合)构造的实心金属线、条带、圆柱状管、或线圈，其可以屈曲(bends)或以其他方式弯曲或活动定向以促进电极906和相应的血管壁之间的接触。在图解的实施方案中，中间部分908弯曲或屈曲以将电极906定位在距离轴904的纵轴S尺寸Y处。尺寸Y可以从约2mm变化到约20mm。在一些构造中，Y尺寸可以是约10mm至约20mm。例如，在图解的实施方案中，尺寸Y是约16mm。例如，人肾动脉的平均直径是约3mm到约8mm。因此，如果轴904定位在具有8mm直径的动脉壁附近，中间段908对于电极906将具有足够的挠曲或拱形以接触所述动脉的相对壁。然而，在其它实施方案中，尺寸Y可以具有不同的值并且可以是特大的以促进在直的或弯曲的血管中的接触。
中间部分908还配置成将电极906定位在距离轴904的末端部分904b尺寸X处。至少部分地，尺寸X可以基于构成中间部分908的材料(例如，不锈钢或镍钛金属互化物)和探针900的所需工作长度或有效长度而改变。例如，中间部分908的尺寸X应该配置并且定尺寸成提供足够的壁接触压力，以致电极906可以产生所需的治疗效果。
在备选实施方案中，拉或推金属线可用于活动地弯曲中间部分以促进所述电极的放置。例如，如图9L至9N中所图解，探针980的电极尖端985可以利用致动器金属线982偏转或转向。致动器金属线982可以从如图9L中所示的第一位置或没有偏转的位置986，拉到如图9M所示的轻微偏转的第二位置987，拉到如图9N所示的实质偏转的第三位置988。当试图在弯曲的血管中实现壁接触时，例如，探针980的可变偏转可能是特别有帮助的。
回到参考图9I，轴904具有大约0.014英寸至大约0.085英寸的外径D。至少部分地，轴904的外径D可以基于电极906的外径而改变。例如，在图解的实施方案中，所述轴904具有约0.040英寸的外径D，其对应电极906的一个具体的构造。
电极906具有约0.020英寸至约0.085英寸的外径E。在所图解的实施方案中，例如，电极906具有约0.049英寸的外径E。然而，从实用的观点，这些尺寸可以改变，相比于递送电极906所通过的鞘或引导导管(例如，鞘910)的内径，电极906的外径E可以不是更大的。在一个具体实施例中，8French引导导管(其具有0.091英寸的内径)将类似地是用于接入肾动脉的最大导管。因而，在该情况下使用的电极将具有至少大约小于0.085英寸的外径E。
在备选实施方案中，可以这样配置所述导管，以致所述鞘不覆盖整个电极，但是相反地仅用于基本上使导管的中间部分变直以促进对于治疗位置的递送。在这样的构造中，所述鞘的远端将邻接所述电极的近端。因此，由所述鞘的内径限制电极尺寸不是必需的。
图9J是血管内装置950的实施方案的示意性侧视图，其包括具有成型的或自展开的电极906的探针900。可以将电极906递送到在鞘910之内的治疗部位，然后在已经将它从鞘910的腔除去以后，它可以移动到预先选择的形状。例如，可以通过推进轴904和/或缩回轴904而从鞘910除去电极906。电极906接触用于递送治疗的血管壁。任选地，轴904可以旋转成相对于血管壁旋转电极906并且有角度地再定位电极906。可以在单个有角度的位置或在多个有角度的位置递送所述治疗。任选地，可以通过如所示的鞘910递送输注物I。
应当理解，在这里公开的任何实施方案中，导线可以任选地用于促进探针的递送和/或除去。在这样的实施方案中，所述探针可以在结构增强(例如，导线腔)的情况下另外配置用于适应导线的使用。
另外地或备选地，装置950可以包括多个有角度间隔的电极906，其定位在血管系统内，如图9K所示。除有角度的间距之外，电极906可以纵向间隔以促进在血管的纵向段上的治疗(例如，以实现沿着纵向段而不是沿着横截面的周围治疗)。
除用于热诱导的肾神经调制的血管外和血管内系统之外，还可以提供血管内到血管外的系统。例如，血管内到血管外的系统可以具有电极，所述电极被递送到血管内位置，然后在递送热能场之前至少部分经过/跨越血管壁到达血管外的位置。与电极的完全血管内定位相比，电极的血管内到血管外的定位可以将电极更接近于靶神经纤维放置，以用于递送热能场。申请人已经在前描述了血管内到血管外的脉冲电场系统，例如，在2005年12月29日提交的共同未决的美国专利申请11/324,188中，将其通过参考全部结合于此。
图10是示意性侧视图，其图解用于热诱导的肾神经调制的血管内到血管外的(“ITEV”)系统900的实施方案。ITEV系统900包括导管922，其具有(a)多个在近端侧孔924终止的近端电极腔，(b)多个在远端侧孔926终止的远端电极腔，和(c)导线腔923。导管922优选包括相等数量的近端和远端的电极腔和侧孔。ITEV系统900还包括可以通过近端电极腔和近端侧孔924推进的近端针式电极928，以及可以通过远端电极腔和远端侧孔926推进的远端针式电极929。备选地，图10中图解的实施方案可以用单一针式电极配置，其配置用于单极能量递送。
导管922包括任选的可展开的定位元件930。定位元件930可以包括，例如，可臌胀的气囊或可展开的筐或笼。在使用中，定位元件930可以展开，之后针式电极928和929展开以将导管922定位或定中心在患者的血管内(例如，在肾动脉RA内)。使导管922定中心预计促进全部针式电极928和929递送到在患者血管之内/患者血管以外的所需深度(例如，递送全部针式电极928和929到大约相同深度)。在图10中图解的实施方案中，定位元件930在近端侧孔924和远端侧孔926之间，并且因此，定位元件930在近端和远端电极的递送位置之间。然而，应该理解，另外地或备选地，定位元件930可以沿着导管922的长度定位在不同的位置或在多种位置(例如，在侧孔924的近端位置和/或在侧孔926的远端位置)。
如图10所示，导管922可以经过导线(未显示)经由腔923推进到在患者血管系统之内的治疗部位。在血管内递送期间，针式电极928和929可以这样定位，以致它们的非绝缘的和锐化的远端区域分别定位在近端腔和远端腔内。一旦处于治疗部位，则医疗专业人员可以将电极928和929经由它们位于患者以外的近端区域推进。这样的推进分别使电极928和929的远端区域分别地离开侧孔924和926，并且刺穿患者血管系统的壁以便电极经由ITEV方法在血管外定位。
近端电极928可以连接到场发生器(未显示)作为活动的电极，并且远端电极929可以充当返回电极。用这样的方式，近端和远端电极928和929形成将热能场与患者血管系统的纵轴或方向排列的双极电极对。备选地，远端电极929可以包括活动的电极并且近端电极928可以包括返回电极。而且，近端电极928和/或远端电极929可以都包括活动电极和返回电极。仍然进一步地，近端电极928和/或远端电极929可以与外部接地结合使用，用于递送单极热能场。可以使用活动电极和远端电极的任何组合。
当电极928和929连接到场发生器并且血管外定位时(并且在定位元件930任选展开的情况下)，热能场的递送可以经由加热提供所需的肾神经调制。在实现所需的热诱导肾神经调制以后，电极928和929可以缩回在近端和远端腔之内，并且定位元件930可以折叠以回收。然后可以从患者除去ITEV系统900以完成所述程序。另外或备选地，系统900或在这里公开的任何系统可以重新定位以在另一个治疗部位提供治疗，诸如提供双侧肾神经调制。
冷却元件，诸如对流的冷却元件，可以用于在通过产生热的热诱导的肾神经调制期间保护非靶组织如平滑肌细胞免于热变。可以通过将热能聚焦在靶神经纤维上以保护非靶组织，以致热能强度不足以诱导远离靶神经纤维的非靶组织中的热变。
虽然图3A-8B和10图解双极系统，但是应当理解，备选地，可以使用单极系统，如图9A-9N中所示。例如，活动的单极电极可以定位在血管内、血管外、或血管内到血管外，接近于促进肾功能的靶神经纤维。返回电极可以附着于患者的外部或远离活动电极定位在患者中。最终，热能场可以在体内单极电极和远程电极之间递送，以实现所需的热诱导的肾神经调制。另外地，单极装置可以用于双侧的肾神经调制。
以上参考图3A-10描述的实施方案一般涉及通过递送用于调制靶神经纤维的热能场的用于热诱导的肾神经调制的方法和系统。然而，应该理解，可以提供用于热诱导(通过加热和冷却两者)的肾神经调制的备选方法和系统。例如，电场可以用于用热电元件或帕尔贴元件冷却和调制神经纤维。同样，任选可以通过电阻加热，通过加热的或冷却的流体的递送(参见图11和13)，通过帕尔贴元件(参见图12)等实现热诱导的肾神经调制。另外地或备选地，可以通过将高强度聚焦的超声波施加到靶神经纤维而实现热诱导的肾神经调制(参见图14A、14B、和15)。可以依照本发明公开内容使用另外的和备选的用于热诱导的肾神经调制的方法和系统。
例如，图11是通过施加热能用于热诱导的神经调制的装置1000的备选实施方案的示意性侧视图。在该实施方案中，图10的电极328和329已经分别用输注针1028和1029替换。可以将传热流体F通过输注针1028和1029递送到靶神经纤维。可以加热传热流体F以便将靶神经纤维的温度增加在所需阈值以上。例如，神经纤维的温度可以升高在约37℃的体温以上，或约45℃的温度以上。备选地，可以冷却传热流体F而将靶神经纤维的温度降低到所需阈值以下。例如，可以将神经纤维冷却以低于约37℃的体温，或进一步地冷却在约20℃以下，或更进一步地冷却在约0℃的冷冻温度以下。显而易见的是，除血管内到血管外递送传热流体之外，传热流体F可以以下列方式递送：血管内(例如，可以通过气囊构件膨胀和/或被循环)，血管外(例如可以通过血管套循环)，或其组合。
另外地或作为传热流体通过输注针1028和1029注射到靶神经纤维的备选，可以注射备选的神经调制剂诸如药物或药剂以调制，使坏死或以其它方式阻塞或减少沿着靶神经纤维的传送。备选的神经调制剂的实例包括，但不限于，苯酚和神经毒素，诸如肉毒杆菌毒素。另外的神经调制剂，本身是已知的，对于本领域技术人员将是显而易见的。
图12是示意性侧视图，其图解通过将热能施加到靶神经纤维而用于热肾神经调制的装置1100的又一个实施方案。装置1100包括肾动脉套1102，其具有一个或多个电连接到内部或外部电源1104的集成热电元件。热电元件利用熟知的帕尔贴效应(即，由电压诱导的热梯度的建立)以实现热肾神经调制。
电流从电源1104经过到达套1102的热电元件。所述热电元件可以包括两种不同的金属(例如，p-型和n-型半导体)，其在两个接合处相互连接。电流诱导两个接合处之间的温度梯度，因此一个接合处冷却而另一个被加热。跨越两个接合处施加的电压的极性逆转使温度梯度的方向逆转。热电元件的热侧或冷侧向内放射状面对，以便分别地加热或冷却沿着肾动脉运行的靶神经纤维，以实现热肾神经调制。任选地，热电元件的放射状向外表面可以被绝缘以减少对于非靶组织的热变的风险。套1102可以包括一个或多个温度传感器，诸如热电偶，用于监控靶神经纤维和/或非-靶组织的温度，其中所述监控数据可以用作反馈以控制治疗的递送。
图13图解利用帕尔贴效应的装置1200的又一个实施方案。装置1200包括通过进口流体管道1206a和出口流体管道1206b连接到肾动脉套1204的植入的或外部的泵1202。进口流体管道1206a将流体从泵1202传递到套1204，而出口流体管道1206b将流体从套1204传递到泵1202以循环通过套1204的流体。流体储器可以位于套1204、泵1202、和/或流体管道1206a和1206b中。
泵1202还可以包括与流体储器热交换接触的一个或多个热电的或其它热元件，用于冷却或加热被传递到套1204的流体以热调制所述靶神经纤维。装置1200任选可以具有用于在套1204之内流体加热或冷却以及流体循环的自动控制或人工控制的控制器。而且，装置1200可以包括温度和/或肾交感神经活性监控或反馈控制。虽然显示图13的装置1200单向治疗支配单个肾神经的神经纤维，但是应当理解，可以备选地提供神经支配双肾的神经纤维的双侧治疗。
备选地，可以通过脉冲的或连续的高强度聚焦超声波实现热肾神经调制。而且，可以在完全的360°(例如当血管内递送时)上或在小于360°的径向段(例如，当血管内递送、血管外递送、血管内到血管外递送、或其组合时)递送超声波。
例如，图14A和14B是图解超声波装置1300的实施方案的示意性侧视图，所述超声波装置1300包括导管1302，沿着导管1302的轴定位的一个或多个超声波能量转换器1304，和围绕能量转换器1304的可臌胀的气囊1306。图14A图解缩小的递送和回收构造形式的装置1300，并且图14B图解以张开的展开构造形式的装置1300。超声波能量转换器1304通过导体1307连接到超声波信号发生器(未显示)。气囊1306可以具有用于反射超声波的声学反射部分1308和超声波能量可以经过的声学透射部分1309。用这样的方式，所述波可以如所示聚焦在距离导管轴所需焦距定位的焦点或半径P处。在备选实施方案中，能量转换器1304可以直接附着到气囊1306。
焦点距离可以是特定的或动态可变的，以致超声波聚焦在血管之外的靶神经纤维上的所需深度。例如，可以提供一组导管尺寸以允许指定的焦距的范围。例如，动态可变的焦点距离可以通过气囊1306的校准展开而实现。
聚焦超声波可以产生保护非靶组织反转的温度梯度并且选择性影响靶神经纤维以实现通过加热的热肾神经调制。结果，在血管壁处的温度可以小于在靶组织处的温度。
图15图解具有导管1402、导体1403、和凹的超声波能量转换器1404的超声波装置1400的又一个实施方案。凹的超声波能量转换器1404将能量定向到特定的焦点P。因而，凹的能量转换器1404是自聚焦的并且不需要气囊1406(例如，气囊可以在全部点上都是声学透射的)上的反射部分。
以上关于图3A-15描述的系统任选地可以用于量化热诱导的肾神经调制的功效、范围、或细胞选择性，以便监控和/或控制神经调制。如上所述，所述系统还可以包括一个或多个传感器，诸如热电偶或成像能量转换器，用于测量和监控下列一个或多个参数：(a)系统，(b)靶神经纤维，和/或(c)非靶组织。例如，温度升高或降低超过或低于某些阈值预期，将热消融、非消融性改变、冷冻、或以其它方式改变靶神经纤维而因此调制靶神经纤维。
应当理解，在本文公开的任何方法、装置、和系统可以被修改或配置用于调制神经纤维的冷却或冷冻治疗。例如，在本文公开的任何探针可以被修饰成在血管内、血管外或ITEV途径的情况下将冷冻治疗递送到靶神经纤维。
D.用于控制热诱导的肾神经调制的模块和方法
使用在这里公开的用于将治疗递送到靶组织的处理，对能量以受控方式递送到靶神经结构可能是有益的。受控的能量递送将允许热处理的区域延伸到肾筋膜中，同时使到达血管壁的不合需要的能量递送或热效应最小化。受控的能量递送同样可以导致更一致的、可预测的和有效的总体治疗。因此，有益的是结合具有编程指令的控制器或计算机系统用于将到达组织的能量递送到能量递送系统中。另外，这些编程指令可以包括用于使受控的能量递送自动化的算法。备选地，对于靶组织的能量递送可以由操作者或施用治疗的医师人工控制。
在一个实施方案中，例如，控制器可以根据包含多种功率递送特性的算法指挥功率发生器(例如，图3A和3B的场发生器110)。例如，图16是图解控制这样的功率递送过程的方法1600的流程图。方法1600可以实施为被图3A的处理器114或另一种适合的设备(例如，场发生器110)执行的常规计算机程序。方法1600还可以由操作者人工实施。
如图16中所图解，在启动治疗以后，方法1600的第一阶段1602包括监控某些操作参数(例如，温度、时间、阻抗、功率等)。虽然优选这些操作参数是连续监控的，但是备选地，可以定期监控它们。在阶段1604，方法1600包括针对预定参数模式校验所监控的参数以确定参数是否独立地或组合地属于由预定参数模式设定的范围。例如，温度可以被监控并且与预定温度值相比。备选地，温度和阻抗两者都可以被监控并且与温度和阻抗两者的预定参数模式相比。如果监控的参数属于由预定参数模式设定的范围，则在相同的设定继续治疗并且继续监控操作参数。
当确定一个或多个参数或多种组合参数不属于预定参数模式时，则方法1600要求在阶段1606对系统的功率输出进行调节。功率输出调节的方向(即，增加或减少)和程度可以通过利用监控参数的常规以及它们如何针对其它预定参数模式进行比较而确定。例如，如果监控温度和时间并且确定监控的温度和时间超过温度和时间的预定参数分布，则可以减小功率递送。备选地，如果一个或多个监控参数或多种组合形式的监控参数落在预定参数分布以外，则可以增加功率递送。如图16中所示，治疗将继续直到功率递送已经调整到零的水平为止(阶段1608)。
根据算法监控的操作参数可以包括温度、时间、阻抗和功率。离散的温度值可以用于触发能量递送的改变。例如，高的温度值(例如85℃)可以表明组织干燥，在所述情况下，算法可以减少或停止能量递送以防止不合需要的热效应到达靶组织或非靶组织。时间还可以用于防止不合需要的热变到达非靶组织。对于每次治疗，校验设定的时间(例如，2分钟)以避免不确定的能量递送。阻抗可以用于测量组织改变。阻抗显示治疗部位的电性质。如果将热感应的电场施加到治疗部位，则阻抗将随着组织细胞对于电流的电阻变小而降低。如果施加太多的能量，则可能在电极附近发生组织干燥或凝固坏死(coagulation)，随着细胞失去持水和/或电极表面积降低(例如，通过凝固物的积累)，所述电极将增加阻抗。因而，组织阻抗的增加可以指示或预示对于靶组织或非靶组织的不合需要的热变。另外，功率是控制治疗递送中有效的监控参数。功率是电压和电流的函数。算法可以定制电压和/或电流以实现所需功率。上述参数的微分(例如，变化率)还可以用于引起能量递送的改变。例如，可以监控温度的变化率，以致在检测到温度的突然升高的情况下减小功率输出。
为了实施上述控制算法，所述系统可以包括一个或多个计算系统硬件和/或软件模块。备选地，计算机硬件和软件可以用于促进任何能量递送过程或系统。例如，图17图解显示适于在图3A的处理器114或在另一个适合的设备(例如，场发生器110)中使用的执行对于调制肾神经的方法的软件模块1620的功能框图。每个分量可以是以常规编程语言写成源代码的计算机程序、步骤、或工艺，所述编程语言诸如C++编程语言，并且可以为处理器114的CPU的执行而提供。源代码和对象以及字符代码的多种实施可以存储在计算机可读的存储介质中，或以载波形式具体表现在传送介质上。处理器114的模块可以包括输入模块1622，数据库模块1624，处理模块1626，输出模块1628，和显示模块1630。在另一个实施方案中，可以提供软件模块1620用于通过分布式计算方案中的网络服务器的CPU执行。
操作中，输入模块1622接收操作者输入，诸如处理设定点和控制选择，并且将接收的信息或选择传达到其它元件用于进一步处理。数据库模块1624组织记录，所述记录包括操作参数1634、操作者活动1636、和一个或多个警报器1638，并且数据库模块1624便于将这些记录存储到数据库1632并从数据库1632检索。可以使用任何类型的数据库组织，包括平面文件系统，分层数据库，关系数据库，或分布式数据库，诸如由加利福尼亚红杉郡的奥乐克公司(OracleCorporation)提供的那些。
处理模块1626可以处理传感器读数1640(例如，来自图5A中的传感器310)，校验警报器和互锁，并且基于传感器读数1640，产生用于控制场发生器110(图3A)的能量递送过程的控制变量。根据控制变量，输出模块1628可以产生输出信号1642。例如，输出模块1628可以将产生的控制变量从过程模块1626转变成适用于能量输出调制器的输出信号1642。显示模块1630可以通过设备显示、打印、或下载传感器读数1640和输出信号1642，所述设备诸如输出设备120(图3A)或在场发生器110的面上的视觉显示器。适合的显示模块1630可以是视频驱动器，所述视频驱动器可以使处理器114在输出设备120上显示传感器读数1640。
图18是显示图17的处理模块1626的实施方案的框图。处理模块1626可以进一步地包括传感模块1650，计算模块1652，警报模块1654，功率输出模块1656，和相互互连的互锁模块1658。每个模块可以是计算机程序，步骤，或例行程序，将其写成常规编程语言形式的源代码，或一个或多个模块可以是硬件模块。
传感模块1650可以接收传感器读数1640并将其转变成所需单位的参数。例如，传感模块1650可以接收传感器读数1640作为电信号并且将所述电信号转变成摄氏度形式的瞬时温度。传感模块1650可以具有的例行程序包括，例如，线性内插法，对数内插法，数据映射，或其它例行程序以将传感器读数1640结合到所需单位的参数。
计算模块1652可以执行多种类型的计算以促进其它模块的操作。例如，根据下式，计算模块1652可以基于在一段时期内测量的温度得出平均温度：
T a v g = ΣT i N
其中Ti是测量的温度，Tavg是平均温度，N是温度记录的数目。还可以使用其它平均技术，诸如指数移动平均法。计算模块466还可以根据下式得出测量温度的变化率：
d T d t ≈ T i + 1 - T i Δ t
其中Ti+1是温度记录数i+1，Ti是在前的温度记录，并且Δt是两个温度记录之间的时间差。
警报模块1654可以根据来自计算模块1652和/或传感模块1650的输出产生警报。例如，警报模块1654可以相对于预定阈值比较在计算模块1652中计算的平均的或即时的温度(即，预定参数分布)。如果平均的或即时的温度超过阈值，则警报模块1654可以通过升高警报标记(flag)或另一种类型的响应而发出警报。响应于警报标记，输出设备120(图3A)可以通过显示闪光信息、使喇叭发声、打开警告光、和/或提供另一种指示物而发出通知。在某些实施方案中，警报模块1654还可以包括用于实现滞后现象的例行程序(routine)。例如，在平均的或即时的温度超过阈值时，警报模块1654可以封闭警报标记，并且仅当平均的或即时的温度降低到阈值以下达到某一个量时，所述警报模块1654释放警报。
功率输出模块1656可以对于场发生器110产生输出信号1642(图3A和3B)，用于调制场发生器110的功率输出。在一个实施方案中，功率输出模块1656可以根据预定功率递送模式产生输出信号1642。例如，功率递送模式可以包括最大功率水平、最小功率水平、和经过某一段时间从最小功率水平倾斜到最大功率水平的增长率。在其它实施方案中，功率输出模块1656可以根据监控的操作参数数据或来自传感模块1650和/或计算模块1652的其它输出产生输出信号1642。例如，功率输出模块1656可以根据在计算模块1652中计算的平均温度或来自传感模块1650的即时温度改变增长率，如下所述。
互锁模块1658连续监控来源于传感模块1650和/或计算模块1652的操作参数，并且当监控的操作参数超过某些互锁阈值时，互锁模块1658可以控制功率输出模块1656的操作。根据互锁状态，功率输出模块1656可以将功率设定点设定在当前设定点以上或以下(即，增加或降低功率)，或它可以设定功率设定点为零(即，终止功率递送)。例如，当来自计算模块1652的平均温度超过预定值时，互锁模块1658可以使功率输出模块1656减少功率输出。另外地或备选地，当来自传感模块1650的即时温度超过另一个预定值时，互锁模块可以使功率输出模块1656终止它的操作(即，具有零输出值)。在数个实施方案中，互锁模块1658可以任选地配置成直接产生输出信号1642到其他系统元件。
在某些实施方案中，处理模块1626可以包括另外的模块。例如，处理模块1626可以包括用于构造传感模块1650、计算模块1652、警报模块1654、功率输出模块1656和/或连结模块1658的任何一个的构造模块。
处理模块1626还可以包括用于控制所选择的处理参数的控制模块。例如，处理模块1626可以包括用于将处理参数(例如，测量的温度)保持在所需值的比例积分微分(PID)模块。处理模块1626还可以包括一个或多个试图保持一个处理参数(例如，温度)的PID模块，除非所述处理参数被其它处理参数限制(例如，最大功率或阻抗值)。除用于改善控制的PID模块之外，处理模块1626还可以包括前馈模块。例如，前馈模块可以根据所测量的温度、热导性、和/或体腔壁的其它参数计算预期功率水平。然后预期功率水平可以与PID模块的输出结合以补偿任何延迟的响应。
为了更好理解以上参考图16所描述的方法，可能有帮助的是鉴于功率递送分布讨论方法1600。例如，图19是功率随时间变化的图，其显示实施方法1600的一个实施方案的典型响应。一起参考图16-19，方法1600的一个实施方案包括其中互锁模块1658校验互锁条件(即，监控的操作参数对预定的参数分布)的功能，其对应图16的阶段1602和1604。如果任何互锁状态存在，则在阶段1606，互锁模块1658调节功率输出或递送(例如，增加/降低功率水平或迫使输出到零)。如果确定功率水平在阶段1608调节到零，则终止治疗。互锁条件可以包括指示不安全的或不希望的操作状态的那些，或指示不完全的能量递送的那些。例如，下列是可以作为互锁条件的非穷尽的事件列表：
(1)测量的温度超过最大温度阈值(例如，约70°至约85℃)。
(2)由测量温度获得的平均温度超过平均温度阈值(例如，约65℃)。
(3)测量温度的变化率超过变化率的阈值。
(4)经过一段时期的温升低于最小温度变化阈值，而场发生器110(图3A)具有非零输出。在电极108和壁之间的不良接触可以引起这样一种状态。
(5)测量的阻抗超过阻抗阈值(例如，＜20欧姆，或＞500欧姆)。
(6)测量的阻抗超过相对的阈值(例如，阻抗从起始值或基线值降低然后升高超过该基线值)。
如图19中所图解，第一互锁状态发生在0时刻(即，操作者已经对治疗进行初始化并且计时器开始从零计数的时刻)。在该情况下，方法1600在阶段1606继续，功率输出模块1656控制场发生器110以经过第一时段(0-t1)(例如，15秒)逐渐调节它的功率输出到第一功率水平P1(例如，5瓦)。功率输出模块470可以产生和传送功率设定点到场发生器110作为输出信号1642。在一个实施方案中，如图19中图解，在第一时段期间的功率增加一般是线性的。结果，场发生器110以基本恒定速率P1/t1增加它的功率输出。在其它实施方案中，功率增加可以是非线性的(例如，指数的或抛物线的)，具有可变的增长率。
在第一时段届满以后(或在P1的功率水平已经实现以后)，功率输出模块1656可以控制场发生器110以保持它的当前输出功率水平在P1，即，暂停第二时段(t1-t2)。操作者或预编程的例行程序可以根据患者的生理学特征调节所述时段(t1-t2)。例如，如果患者体腔响应于温度改变而减缓，则操作者或预编程的例行程序可以增加时段(t1-t2)以补偿另外的响应延迟。在其它实施方案中，功率输出模块1656可以使场发生器110在第二时段(t1-t2)或任何其它时段(例如，第一时段或随后的时段)期间将输出水平减少到小于P1或暂时终止它的输出水平。
在第二时段届满以后，计算模块1652可以根据来自传感模块1650的温度得出在第二时段结尾时的平均温度，即，t2。方法1600可以继续测试以确定在t2计算的平均温度是否超过预定阈值(例如，65℃)。如果平均温度超过预定阈值，则功率输出模块1656可以控制场发生器110以保持它的当前输出功率水平持续所需的总治疗时间。
如果平均温度不超过预定阈值，则方法1600可以在阶段1606继续，功率水平Pi从Pi增加ΔP的量。在一个实施方案中，ΔP可以是预定的固定量(例如，0.5瓦)。在其它实施方案中，ΔP可以是可变的量。例如，平均温度和最大温度阈值之间的差异可以根据下式确定ΔP：
ΔP＝k×(Tmax-Tavg)
其中k是用户选择的或预定的常数，Tmax是最大温度阈值，并且Tavg是平均温度。
方法1600可以继续另一个测试以确定增加的功率水平(Pi+ΔP)是否超过场发生器110的最大功率水平(例如，10瓦)。操作者或预先编程的例行程序可以选择最大功率水平以表示安全的或优选的操作方式并且根据治疗条件调节所选择的功率水平。如果超过最大功率水平，则功率输出模块1656控制场发生器110以保持它的当前输出功率水平直到达到所需的总治疗时间。如果不超过最大功率水平，则所述过程返回到暂停，并且重复随后的阶段。虽然上述方法1600的具体实施例使用测量的温度作为处理参数，但是代替测量温度或除测量温度之外，可以使用其它生理学参数(例如，阻抗、电阻率、和/或电容)和非生理学参数(例如，时间、功率等)。
任选地，计算模块1652可以计算在达到最大功率水平以前的循环数目。例如，当使用固定的ΔP时，计算模块1652可以根据下式计算循环数目：
n = p m a x - P 1 Δ P
其中Pmax是最大功率水平，并且n是循环数目。
在倾斜向上过程结束以后，根据计算的平均温度、测量温度的变化率、阻抗的变化率和/或其它参数，功率输出模块1656还可以控制场发生器110以改变它的功率输出水平。例如，如下所讨论，当测量的温度以超过变化率阈值的变化率递增时或当测量的即时温度超过另一个预定阈值时，功率输出模块1656可以控制场发生器110以离散地或连续地降低它的功率输出水平。
方法1600还可以任选地包括倾斜的过程，其容许功率水平以更快变化率增加。例如，方法1600可以包括测试以检验平均温度并且确定它是否低于预选择的阈值(例如，50C)。如果平均温度低于阈值，则功率输出模块1656可以控制场发生器110以增加功率水平Pi达等于ΔPxF的量，其中F是步进因子(stepfactor)(例如，2)。可以在每个倾斜阶段开始时或在所述倾斜过程其它所选择的点重复所述测试。迅速倾斜过程预计允许功率输出水平更快地达到它的所需治疗水平。在另一个实施方案中，其中PID模块用于控制功率输出，当测量的温度远低于指定水平(例如，65C)时，可以调谐所述PID模块以快速向上倾斜功率，但是随着测量温度接近指定水平而减缓所述功率倾斜。
方法1600还可以任选地包括功率减少过程以逐渐地降低或向下倾斜治疗期间的功率水平。以上具体描述的实施例设计功率输出过程以通过温度监控减少使患者体腔壁过热的风险。在其中达到最大功率水平的情况下，温度和/或测量的阻抗可以继续升高超过某一阈值。在许多情况下，超过这样的阈值可以是可以达到警报阈值的指示器，其中功率输出将要终止。然而，如下所述的方法可用于降低功率以防止由于温度和/或阻抗达到警报阈值而导致的功率递送的过早终止。
在功率递送期间，互锁模块1658可以连续监控从传感模块1650和/或计算模块1652接受的一个或多个操作参数。例如，该方法可以包括确定计算的平均温度是否大于或等于预定的阈值Tt(例如，70℃)的测试。如果平均温度不超过预定阈值Tt，则互锁模块1658不中断功率输出模块1656的操作并且保持当前的功率输出水平用于治疗。
另一方面，如果平均温度(来自计算模块1652)超过预定阈值Tt，则所述方法可以继续阶段1606，其中功率水平是减小的。在该功率减少阶段期间，功率输出模块1656可以控制场发生器而将功率立即降低Ps(例如，1瓦)。在降低功率以后，所述方法可以暂停功率输出模块1656达时段Tw(例如，3秒)。在时段Tw届满以后，计算模块1652可以再次根据来自传感模块1650的温度得出平均温度。所述方法可以继续另一个测试以确定计算的平均温度是否还超过预定的阈值Tt。在一些情况下，该功率减少过程可能需要重复若干次，每次将功率降低Ps，直到平均温度不超过预定阈值。如果平均温度不超过阈值，则方法可以在持续的功率阶段的情况下继续达治疗时间的持续时间。
在该实施方案的另一个方面中，所述方法可以包括确定阻抗的增加或增长率是否太大的测试。更具体而言，互锁模块1658可以测量阻抗在固定时段内的斜率。如果测量的斜率不超过预定阈值，则互锁模块1658不调节功率输出模块1656的操作，并且所述方法可以在持续的功率水平继续。然而，如果测量的斜率大于预定阈值Zs(例如，3欧姆/秒)，则所述方法可以进行使上述功率减少。如上所述，功率减少过程可能需要重复若干次直到测量斜率不超过预定阈值Zs。操作者或预编程的例行程序可以根据患者的生理学特征和/或一个或多个所需治疗参数调节预定阈值Tt和Zs或功率减少速率。
在该实施方案的又一个方面中，互锁模块1658可以连续监控阻抗，并且，如果在治疗期间的任一点所述阻抗增加超过最小阻抗加预先选择的阈值，则功率输出可以降低直到阻抗值能够在所需范围之内为止。如果阻抗值不改变在所需范围之内或继续增加超过警报阈值，则功率递送可以终止。
更具体地，该方法可以包括将测量的阻抗值与预先选择的最小阻抗值比较的测试。如果测量的阻抗值小于预先选择的最小阻抗值，则最小值被更新成等于测量值。在治疗期间，这些阶段可以根据需要重复许多次。实际上，所述方法保持对系统测量的最低阻抗值的跟踪。
如果测量的阻抗大于最小阻抗值加预先选择的阈值Zd(例如，20欧姆)，则所述方法可以继续到如上所述的功率减少过程。在降低功率以后，所述方法可以暂停功率输出模块1656达时段Tw2(例如，3秒)。在时段Tw2届满以后，互锁模块1658可以再次监控阻抗，并且，如果测量的阻抗值还大于最小阻抗值加阈值，则所述方法可以根据需要将功率减少过程重复许多次直到阻抗条件不发生为止，然后返回到持续的功率阶段。
方法1600和上述多种实施方案的一个预期优点是对于靶和非靶组织的不合需要的治疗作用的风险(例如，过多破坏体腔壁)减小。如上参考图3A和3B所述，场发生器110可以将电场递送到探针104以将能量施加到体腔壁和周围区域用于实施神经调制。然而，许多因素可以有助于体腔对于施加能量的延迟响应(如测量的温度和/或阻抗所指示)。例如，体腔的潜在热、体腔周围或内部的循环、传感器和体腔壁之间的接触、及其它因素可以引起对于施加的能量的延迟的温度和/或阻抗响应。为了补偿响应中的这种延迟，方法1600可以结合延迟期，其中对于延迟期的持续时间不监控一些参数。结果，可以减轻乃至除去不利的体腔过热。而且，功率减少过程进一步帮助减少过度破坏体腔壁的风险，同时也防止由于参数达到警报阈值而引起的功率递送的过早终止。
预期热诱导的肾神经调制，无论血管外递送、血管内递送、血管内到血管外递送或其组合，可以将CHF、高血压、肾病、心肌梗死、心房纤维性颤动、造影肾病和/或其它肾或心肾病的临床症状减轻数月的时期(潜在地高达六个月或更多)。该时期可以足以允许身体治愈；例如，该时期可以在急性心肌梗死以后减少CHF发作的风险，因此减轻对随后的再治疗的需要。备选地，当症状复发时，或在规律安排的时间间隔，患者可以接受重复治疗。热诱导的肾神经调制还可以系统地减少交感神经过敏。
虽然在这里公开的治疗涉及通过去神经支配调制对肾功能起作用的神经，但是应当理解可以这里配置本文公开的方法、装置、和系统和/或修改用于身体之内的其它位置的治疗能量传递。例如，可以修改这些发明用于在体腔之内的能量递送目的(例如外周血管)以实现去神经支配或一些其它的治疗结果。
从以上应当理解，本发明的具体实施方案已经为了说明而描述于此，但是熟知的结构和功能没有显示或详细地描述以避免不必要地使本发明实施方案的描述不清楚。在上下文准许的情况下，单数的或复数的术语还可以分别包括复数或单数的术语。而且，除非措辞“或”在关于两个或更多项目列表时特意限于仅指单个项目而排除其它项目，则在这样一种列表中的“或”的使用应当解释为包括(a)所述列表中任何单一项目，(b)所述列表中全部项目，或(c)所述列表中项目的任何组合。另外，在全文中使用术语“包括”的含义是包括至少所述的一个或多个特征，因此不排除任何更大数量的相同特征和/或另外类型的其它特征。还应当理解，具体的实施方案已经为了说明的目的而描述于此，但是在不背离本发明的情况下可以获得多种变体。因此，本发明仅受后附的权利要求限定。

Claims (13)

1.一种用于热诱导的肾神经调制的装置，所述装置包括：
导管，所述导管被配置成用于血管内放置在人患者的肾血管中，其中所述导管包括定位元件，
其中所述定位元件可展开；和
一个以上电极，所述电极适于被所述定位元件定位于与肾血管内壁相接触，
其中，所述电极被配置成将热能跨管壁递送至神经支配患者的肾的靶神经纤维，以至少部分使所述肾去神经支配，
其中所述定位元件包括气囊，并且
其中所述一个以上电极固定在所述定位元件的外表面，
其特征在于所述装置还包括多个延伸，其中所有延伸都从近端伸出，至少部分地在所述定位元件的表面上展开，其中所述延伸是选择性绝缘的，从而仅所述延伸的远端部分是电活性的。
2.根据权利要求1所述的装置，其中由所述一个以上电极递送的热能包括连续或脉冲电场。
3.根据权利要求1和2之一所述的装置，其中所述电极是可动态分配的。
4.根据权利要求3所述的装置，其中所述电极被配置成用于双极能量递送或被配置成用于单极能量递送。
5.根据权利要求1至4之一所述的装置，其中全部或部分所述电极是镀金的。
6.根据权利要求1至5之一所述的装置，其中来自所述电极的热能适于引起至少一个靶神经纤维的至少部分消融。
7.根据权利要求1至6之一所述的装置，所述装置还包含一个以上传感器。
8.根据权利要求7所述的装置，其中所述传感器是用于监测温度的热电偶和/或阻抗传感器。
9.根据权利要求8所述的装置，其中所述一个以上电极具有一个以上热电偶。
10.根据权利要求1-9之一所述的装置，其中所述定位元件是主动展开的。
11.根据前述权利要求任一项所述的装置，所述装置还包括将所述一个以上电极连接于导管的轴的近端连接件，其中所述多个延伸从所述近端连接件伸出。
12.根据前述权利要求任一项所述的装置，其中所述定位元件被配置成用于改变血管内的阻抗和用于跨血管壁按线路发送电能量。
13.根据权利要求1至12之一所述的装置，所述装置还包括场发生器。
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