CN101583323A - 用于对体腔进行非连续周缘治疗的方法和装置 - Google Patents

用于对体腔进行非连续周缘治疗的方法和装置 Download PDF

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CN101583323A
CN101583323A CNA2007800496467A CN200780049646A CN101583323A CN 101583323 A CN101583323 A CN 101583323A CN A2007800496467 A CNA2007800496467 A CN A2007800496467A CN 200780049646 A CN200780049646 A CN 200780049646A CN 101583323 A CN101583323 A CN 101583323A
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energy transfer
transfer element
body cavity
energy
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CN101583323B (zh
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丹尼斯·德马雷
汉森·吉福德
尼古拉斯·扎德诺
马克·迪姆
本杰明·J·克拉克
安德鲁·吴
肯尼斯·J·米希里奇
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Medtronic Ardian LLC
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Abstract

本发明提供了用于体腔的不连续周缘治疗的方法和装置。装置可以被安置在患者的体腔内，并且可以在第一纵向和有角度的位置传递能量，以在第一位置产生小于完全周缘的治疗区。所述装置还可以在体腔内的一个或多个另外的纵向和有角度的位置传递能量，以在一个或多个另外的位置产生一个或多个小于完全周缘的治疗区，所述一个或多个另外的位置纵向地并且有角度地从所述第一治疗区偏置。所述第一治疗区和所述一个或多个另外的治疗区的叠置限定了没有连续周缘损害形成的不连续周缘治疗区。本发明提供了用于实现这种不连续周缘治疗的方法和装置的各种实施方案。

Description

用于对体腔进行非连续周缘治疗的方法和装置
相关申请的引用
本申请要求下列共同未决的美国专利申请的每一项的优先权：
(1)在2006年11月14日提交的美国专利申请11/599,890。
(2)在2005年5月13日提交的美国专利申请11/129,765，所述美国专利申请11/129,765(a)要求在2004年10月5日提交的美国临时专利申请60/616,254以及在2004年11月2日提交的60/624,793的权益；并且(b)是在2003年4月8日提交的美国专利申请10/408,665的部分继续申请，所述美国专利申请10/408,665要求在2002年4月8日提交的美国临时申请60/370,190、在2002年10月3日提交的60/415,575以及在2003年1月29日提交的60/442,970的权益。
(3)在2005年7月25日提交的美国专利申请11/189,563，所述美国专利申请11/189,563(a)是在2005年5月13日提交的美国专利申请11/129,765的部分继续申请，所述美国专利申请11/129,765要求在2004年10月5日提交的美国临时专利申请60/616,254以及在2004年11月2日提交的60/624,793的权益；并且(b)是在2004年7月28日提交的美国专利申请10/900,199(现在为美国专利6,978,174)的部分继续申请，所述美国专利申请10/900,199是2003年4月8日提交的美国专利申请10/408,665的部分继续申请，美国专利申请10/408,665要求在2002年4月8日提交的美国临时申请60/370,190、在2002年10月3日提交的60/415,575以及在2003年1月29日提交的60/442,970的权益。
所有的上述申请和专利通过引用而以全文形式结合在此。
通过引用的结合
本说明书中提及的所有出版物和专利申请都通过引用而结合在此，达到就像具体并单独地指出将每一个单独的出版物或专利申请通过引用而结合一样的程度。
技术领域
本发明涉及用于进行体腔内非连续周缘治疗的方法和装置。这种方法和装置的几个实施方案旨在体腔的周缘治疗，所述体腔的周缘治疗在一个或多个离散的治疗区域中施加能量，以形成一个或多个损害，所述一个或多个损害在垂直于体腔的纵轴的横截面的任何完全的周缘周围不接触或连续。
背景
本申请人已经描述了这样的方法和装置，所述方法和装置通过调节有助于肾功能的神经纤维，例如将含有有助于肾功能的神经纤维的组织去神经支配，从而治疗多种肾和心-肾疾病，例如心力衰竭、肾疾病、肾衰竭、高血压、造影剂肾病、心房纤维性颤动和心肌梗死。这预期降低肾交感神经活性，其增加了水和钠从身体的移去，并且使肾素分泌返回到更加正常的水平。正常化的肾素分泌引起供应肾的血管呈现出稳定的扩张/收缩的状态水平，这提供了适当的肾血流量。参见，例如，本申请人的共同未决美国专利申请：(a)在2003年4月8日提交的10/408,665；(b)在2005年5月13日提交的11/129,765；(c)在2005年7月25日提交的11/189,563；(d)在2006年2月27日提交的11/363,867；(e)在2006年8月14日提交的11/504,117；以及美国专利6,978,174。所有的这些申请和专利都通过引用而以全文形式结合在此。
本申请人之前还描述了这样的方法和装置，所述方法和装置用于患者内的神经支配血管或接近血管的任何靶神经纤维的血管内-诱导神经调节或去神经支配，例如用于治疗任何神经障碍或其它的医学病症。接近血管的神经可能使效应器官或组织受神经支配。血管内-诱导神经调节或去神经支配可以用于治疗多种神经障碍或其它的医学病症，所述神经障碍或其它的医学病症包括但不限于：包括心力衰竭和高血压的上述病症，以及疼痛和外围动脉闭塞病(例如，经由疼痛缓解)。该方法和装置可以用于调节传出或传入神经信号，以及传出和传入神经信号的组合。参见，例如，在2006年11月14日提交的题目为用于血管内-诱导神经调节或去神经支配的方法和装置(Methods and Apparatus for Intravascularly-Induced Neuromodulationor Denervation)(代理人备案号57856.8018.US)的本申请人的共同未决美国专利申请11/599,649，所述专利申请通过引用而以全文形式结合在此。
尽管上述方法本身是有用的，但是血管内神经调节和/或去神经支配的一个挑战是从血管的内部充分地影响神经组织。例如，血管内神经调节应当避免增加急性和/或晚期狭窄的危险。因此，将期望提供进一步解决这些挑战的方法和装置。
附图简述
考虑到结合附图的下列详细描述，本发明的几个实施方案将变得显然，在所述附图中，所有附图的类似参考字符是指类似的部分，并且其中：
图1是显示紧邻动脉的神经纤维的一般位置的示意性等距详图。
图2A-2J是部分截面形式的示意性侧视图，其示例了用于体腔的非连续周缘治疗的方法和装置的一个实例。
图3是部分截面形式的示意性侧视图，其示例图2的方法和装置的一个备选实施方案。
图4是部分截面形式的示意性侧视图，其示例用于非连续周缘治疗的其他备选方法和装置。
图5A和5B是部分截面形式的示意性侧视图，其示例用于非连续周缘治疗的更进一步的备选方法和装置。
详细描述
A.概述
本申请人已经发现，可以期望通过对离散区施加能量来进行体腔的周缘治疗以积极地影响医学病症，所述离散区沿大体上垂直于腔壁的径向横截面的完全的周缘是非连续的。例如，在心房纤维性颤动的治疗中，通过形成连续的周缘损害以中断异常电信号，可以实现周缘治疗，所述连续的周缘损害在肺静脉的径向横截面周围完全连续。在心力衰竭的治疗中，通过形成类似的连续的周缘损害以降低肾交感神经活性，可以实现周缘治疗，所述类似的连续的周缘损害在肾动脉的径向横截面周围完全连续。然而，在垂直于体腔或接近体腔的组织的径向横截面的周缘几乎完全360°连续延伸的连续周缘损害可能增加血管内急性和/或晚期狭窄形成的危险。因此，许多下述实施方案旨在形成腔内的离散的、非连续的损害，而不不利地影响血管。
这种非连续治疗可以例如从血管内或管腔内位置实施，其可以包括利用从血管内位置通到血管外位置的元件的治疗，即血管内-至-血管外治疗。然而，应当理解，还可以提供根据本发明的血管外治疗装置和方法。
本治疗可以相对地应用于神经，包括脑中的神经组织，或在血管或其它体腔内或接近血管或其它体腔、至少总体上平行或沿着血管(体腔)的纵向维度行进的其它靶结构。该靶结构另外或备选地可以包括相对于血管(体腔)的旋转取向。非连续周缘治疗的几个公开的实施方案通过沿多个径向平面或横截面的多个部分处理神经物质，可以降低急性和/或晚期狭窄形成的危险，所述多个径向平面或横截面的多个部分沿血管(体腔)的纵向维度被隔开。
在每一个径向平面或横截面的治疗区域限定了沿周缘不完全连续的治疗区，即，限定了没有连续周缘损害的治疗区。然而，沿多个径向平面或横截面的多个治疗区的叠置限定了沿血管(体腔)的纵向节段的非连续的、重叠的周缘治疗区。在一些实施方案中，此重叠的治疗区可以提供非连续的，但是基本上完全的周缘治疗，而没有连续周缘损害的形成。在其它的实施方案中，重叠的治疗区可以提供非连续的、部分的周缘治疗。
与在单个的纵向横截面或径向平面的连续周缘治疗相比，以此方式在血管(体腔)的纵向节段上进行不连续的周缘治疗。因而，周缘地以不连续的方式影响基本上沿血管(体腔)的纵向维度行进的靶结构，而没有沿血管(体腔)的任何横截面或径向平面的连续周缘损害的形成。这可以降低血管(体腔)内急性或晚期狭窄形成的危险。因而，不连续的周缘治疗可以包括在体腔的纵向维度周围的多个位置进行的治疗，其中在任何一个纵向位置的治疗区不包括完全在径向平面周围的连续周缘损害，但是其中在全部或一些纵向位置的治疗区的叠置可以限定重叠的周缘治疗区。
经由在体腔内接近靶神经纤维安置的用于对靶神经纤维施加能量的装置，可以任选地实现不连续的周缘治疗。该治疗可以经由下列方式引起，例如，电和/或磁能应用、热能应用(加热或冷却)、机械能应用、化学能应用、核或辐射能应用、流体能应用等。这样的治疗可以经由，例如，热或非热电场、连续或脉冲电场、激励电场、局部药物递送、高强度聚焦超声、热技术、无热技术、它们的组合等实现。这种治疗可以例如实现不可逆的电穿孔或电融合、坏死和/或凋亡的诱导、基因表达的改变、动作电位阻滞或衰减、细胞因子上调的变化、消融以及靶神经纤维中的其它状况。该装置的全部或一部分任选可以通过体腔壁达到腔外位置，以帮助所述治疗。该体腔可以例如包括血管，并且该装置可以经由熟知的经皮技术安置在血管内。
经由对靶结构(例如靶神经结构)的直接改变，或至少部分地经由对血管或支持靶结构或周围组织如动脉、小动脉、毛细管、静脉或小静脉的其它结构的改变，可以实现治疗。在一些实施方案中，经由将能量直接施加于靶或支持结构，可以实现该治疗。在其它的实施方案中，经由间接产生和/或施加能量，例如通过施加在靶或支持结构中引起阻抗性加热的电场或高强度聚焦超声，可以实现该治疗。还可以利用备选的热技术。
在一些实施方案中，可以提供用于实时监控治疗及其对靶或支持结构和/或非靶组织的效果的方法和装置。同样地，可以提供能量传输装置的实时监控。另外地或备选地，可以监控传输的功率或总能量、靶或非靶组织或装置的阻抗和/或温度。
当利用电场实现期望的周缘治疗时，可以将电场参数根据需要更改并且以任意组合结合。这样的参数可以包括但不限于电压、功率、场强、脉冲宽度、脉冲持续时间、脉冲的形状、脉冲的数量和/或脉冲之间的间隔(例如，工作循环)等。例如，适当的场强可以高达约10,000V/cm，并且可以是连续的或脉冲的。电波形的适当形状包括例如AC波形、正弦波形、余弦波形、正弦和余弦波的组合、DC波形、DC-移位的AC波形、RF波形、方波、梯形波、指数衰减波、或它们的组合。
当利用脉冲电场时，适当的脉冲宽度可以具有任何期望的间隔，例如高达约1秒。该场包括至少一个脉冲，并且在许多应用中，该场包括多个脉冲或被连续施加例如高达几分钟。适当的脉冲间隔包括例如小于约10秒的间隔。这些参数被作为适当的实例提供并且绝不应当被认为是限制性的。
当利用热机构实现期望的治疗时，可以任选提供保护性元件，以在热诱导的不连续周缘治疗期间保护非靶组织如平滑肌细胞免受热损伤。例如，在加热靶神经或支持结构时，可以提供保护性冷却元件如对流冷却元件，以保护非靶组织。同样地，在冷却靶神经或支持结构时，可以利用保护性加热元件如对流加热元件，以保护非靶组织。可以直接或间接地将热能短暂施加或施加一段持续的时期，以实现例如期望的神经调节或去神经支配。任选地，可以将反馈如沿靶或非靶组织或沿所述装置的感应温度用于控制并监控热能的传递。
通过利用血流作为吸收过量热能(热的或冷的)的传导和/或对流散热器，可以在例如神经调节或去神经支配的过程中任选保护非靶组织。例如，当血流不阻塞时，循环血可以提供相对不变的温度介质，以在此程序中将过量的热能从非靶组织移去。另外地或备选地，可以通过下列方法保护非靶组织：将热(或其它的)能聚焦在靶或支持结构上，使得能量的强度不足以在远离靶或支持结构的非靶组织中引起热损伤。
如以下所述的，可以利用另外和备选的方法和装置实现不连续的周缘治疗，而不形成连续的周缘损害。为了更好地理解本发明的装置的结构以及使用这种用于不连续周缘治疗的装置的方法，研究人的一般神经血管解剖结构是有益的。
B.神经血管解剖结构概述
图1示例了相对于典型为动脉的体腔或血管结构，神经结构的一般解剖学布置。神经纤维N通常可以在沿动脉A的径向维度r的位置的较小范围附近，通常在动脉的外膜内，沿纵向维度L纵向延伸。动脉A具有平滑肌细胞SMC，平滑肌细胞SMC包围动脉周缘并且通常围绕动脉的角维度(angular dimension)θ成螺旋形，还在沿径向维度r的位置的较小范围内。因此，动脉的平滑肌细胞具有通常横穿(即，不平行)血管的纵向维度的纵向或较长维度。神经纤维和平滑肌细胞的纵向维度的失配被称为“细胞失配(cellular misalignment)”。
可以使用神经N和平滑肌细胞SMC的细胞失配，在对平滑肌细胞具有减小的影响的情况下选择性地影响神经细胞。更具体地，通过沿着动脉A的沿动脉纵向维度L分开的多个径向或横截面平面进行叠置治疗，而非进行沿动脉的单个径向平面或横截面的连续周缘治疗，可以实现不连续的周缘治疗。以此方式，由于细胞失配，纵向取向的神经纤维可以经历完全的不连续的周缘治疗，而有角度地取向的平滑肌细胞可以仅经历部分周缘治疗。可以任选利用监控元件评估在神经和/或在平滑肌细胞中引起的治疗的程度，以及调节用于实现期望效果的治疗参数。
C.用于体腔的非连续周缘治疗的装置和方法的实施方案
图2-5示例了用于进行非连续周缘治疗的血管内系统和方法的实施例。本申请人已经例如在2005年5月13日提交的共同未决美国专利申请11/129,765和2006年2月27日提交的11/363,867中描述了用于神经调节或去神经支配的血管内和血管内-至-血管外系统，所述两个申请通过引用而结合在此。本申请人还描述了用于神经调节或去神经支配的血管外系统(参见，例如，在2005年7月25日提交的美国专利申请11/189,563，所述申请通过引用而结合在此)，并且应当理解，除血管内(管腔内)或血管内-至-血管外(腔内-至-腔外)系统以外，可以使用血管外(或腔外)系统进行不连续的周缘治疗。本申请人之前已经在例如2006年8月14日提交的共同未决美国专利申请11/504,117中描述了用于神经调节或去神经支配的热系统。
现在参考图2A-2J，装置300的实施方案包括具有任选的定位元件304(例如，气球、可膨胀的金属丝篮、其它机械扩张器等)的导管302和可膨胀的电极元件306，所述可膨胀的电极元件306沿所述导管的轴安置并且示意性地位于所述定位元件之上。电极元件306具有用于将电场传递到靶神经纤维的电连接到场发生器50的一个或多个电极307。在一个备选实施方案中，电极元件306的一个或多个电极307中的一个或多个可以包含用于加热或冷却靶神经纤维以调节该纤维的帕尔贴(Peltier)电极。任选地，一个或多个电极307可以是单独可分配的并且可以以双极形式使用，和/或可以在将外部接地垫(ground pad)附着到患者的外部的情况下以单极形式使用。
场发生器50，以及本文中所述的电极实施方案中的任何一种，可以与本发明的任何实施方案一起使用以传递具有期望的场参数的电场。场发生器50可以在患者外部。应当理解，可以将以下所述的实施方案的电极电连接至所述发生器，尽管每一个实施方案没有明确显示或描述该发生器。此外，可以任选将场发生器安置在患者内部，并且可以任选将电极和/或场发生器临时或永久地植入到患者内部。
定位元件304任选可以安置或另外驱动一个或多个电极307与血管壁接触。定位元件304还可以包括阻抗改变元件，所述阻抗改变元件改变治疗期间血管内的阻抗，以导引电场跨越血管壁。这可以减少实现期望的神经调节或去神经支配所需的能量，并且可以降低对非靶组织的伤害的危险。本申请人之前已经例如在2005年11月4日提交的共同未决美国专利申请序列号11/266,993中描述了阻抗改变元件的使用，所述专利申请通过引用而以全文形式结合在此。当定位元件304包括可膨胀气球，如图2A-J中一样，该气球可以作为用于可膨胀电极元件306的定中心和/或膨胀元件，以及作为阻抗改变电绝缘体，用于引导传递的电场经由一个或多个电极307进入或跨越血管壁以调节靶神经纤维。由元件304提供的电绝缘可以减少用于实现期望的靶纤维调节，直至并且包括含有所述靶纤维的组织的完全去神经支配所必需的电场的施加能量或其它参数的量级。
此外，元件304任选可以用作热元件。例如，它可以充有用于从接触该元件的组织移去热量的起散热器作用的冷流体。相反地，元件304可以充有加热与所述元件接触的组织的温热流体。该元件内的热流体任选可以在定位元件304内循环和/或交换，以有助于更有效的传导和/或对流热传递。如以下在本文中更详细地描述的，热流体还可以用于实现经由热冷却或加热机构的热神经调节。
一个或多个电极307可以是单独的电极(即，独立接触头)、具有普通连接的接触头的节段电极或单个的连续电极。此外，一个或多个电极307可以配置用于提供双极信号，或一个或多个电极307可以一起或单独地与用于单极应用的分开的患者接地垫结合使用。作为备选或除一个或多个电极307沿可膨胀电极元件306的布置以外，如图2中一样，可以将一个或多个电极307附着到定位元件304上，使得它们在定位元件膨胀时接触动脉的壁。在这种变化中，所述一个或多个电极可以例如固定到内侧表面、外侧表面或至少部分地嵌入到定位元件的壁内(参见图5A和5B)。在另一个实施方案中，所述一个或多个电极不接触血管壁，而是可以被安置在血管内的任何期望位置。
一个或多个电极307或装置300的任何其它部分，例如导管302或元件304，另外地或备选地可以包含一个或多个传感器如热电偶310，以监控靶组织、非靶组织、电极、定位元件和/或装置300或患者解剖结构的任何其它部分的温度或其它参数。可以使用测量的一个或多个参数作为反馈来控制治疗计划(regime)。此反馈可以例如用于将一个或多个参数保持在期望阙值之下，所述期望阙值例如为可能对非靶组织引起伤害的阙值。相反地，可以将该反馈用于将一个或多个参数保持在期望阙值以上，所述期望阙值例如为可以诱导靶组织中的期望效果，例如靶神经纤维的神经调节或由靶神经纤维支配的组织的去神经支配。此外，可以将该反馈用于将一个或多个参数保持在将在靶组织中引起期望的效果而不造成非靶组织伤害的范围内。可以任选将多个参数(或在多个位置的同一或多个参数)用作控制反馈以保证期望效果同时减轻不期望的效果。
如在图2A中看到的，可以将导管302以低轮廓传递构造，例如通过引导导管或鞘303，在动脉A内(或在静脉或接近靶神经纤维的任何其它血管内)传递到治疗部位。备选地，可以将导管安置在用于神经调节的多个血管内，例如，在动脉和静脉内。用于电场神经调节的多血管技术之前已经例如在2006年7月12日提交的本申请人的共同未决美国专利申请11/451,728中有描述，所述专利申请通过引用而以全文形式结合在此。
一旦被如所期望地安置在脉管系统内，任选的定位元件304就可以膨胀，以张开电极元件306并且使电极307与血管的内壁接触，如图2B中看到的。然后可以由场发生器50产生电场，所述电场通过导管302传递到电极元件306和电极307，并且经由电极307跨越动脉的壁传递。电场调节沿在动脉壁内或接近动脉的神经纤维的活性，例如至少部分地将受神经纤维支配的组织或器官去神经支配。这可以例如经由对靶神经纤维或支持结构的消融或坏死，或经由非消融损伤或其它变化来实现。电场还可以引起神经纤维中的电穿孔。
如在沿图2B的径向平面I--I取得的图2C的横截面图中看到的，装置300示意性地包括在电极元件306和定位元件304的周缘周围相等地隔开的4个电极307。如在图2D中看到的，当以与外部接地(未示出；本身已知)结合的单极形式使用时，被每一个电极治疗的周缘节段重叠以形成离散的治疗区TZI，所述离散的治疗区TZI围绕垂直于血管壁的径向平面中的动脉的周缘不完全连续。结果，在动脉的周缘周围存在离散的未治疗区UZI。
如在图2E中看到的，例如使定位元件304折叠，可以使电极元件306在动脉的径向维度r周围折叠，使得电极307不接触血管壁。电极元件306可以围绕动脉的角维度θ旋转，以有角度地再安置电极307(最佳地在图2G中示出)。该旋转可以例如通过有角度地旋转导管302实现。在图2E中，电极元件示意性地已经围绕动脉的角维度旋转约45°。在图2A-D中所示的装置300的实施方案中，电极在该装置的周缘周围相等地分开，使得45°角旋转约在图2D中所示的电极的初始位置之间的中途再安置电极。
除电极的角度再安置(angular repositioning)以外，可以将电极沿动脉的纵向维度L再安置，这作为电极307和径向平面I-I之间的纵向偏置也显示于图2E中。这种纵向再安置可以在电极的角度再安置之前、之后或同时发生。如在图2F中看到的，一旦在纵向和角维度两者上再安置，电极元件306就可以在径向维度周围再膨胀，以使电极307接触血管壁。然后可以经由有角度地并且纵向地再安置的电极307传递电场。
在图2G中，沿图2F的径向平面II--II的治疗产生了治疗区TZII和未治疗区UZII。与图2D的治疗区TZI一样，图2G的治疗区TZII在动脉的完全周缘不连续。图2H和2I允许了治疗区TZI和治疗区TZII的比较。在图2H和2I中没有显示装置300，例如，可以已经将该装置从患者移去，从而完成该程序。
如所显示的，分别沿径向平面I--I和II--II的非治疗区UZI和UZII有角度地彼此偏置。如在图2J中看到的，通过将沿动脉A的不同横截面或径向平面定位的治疗区TZI和TZII叠置，就形成复合治疗区TZI-II，所述复合治疗区TZI-II在动脉的纵向节段上提供了非连续的、但是基本上周缘的治疗。此叠置的治疗区有益地没有产生沿垂直于动脉的任何单独的径向平面或横截面的连续周缘损害，与产生连续的周缘损害的之前的周缘治疗相比，这可以降低急性或晚期狭窄形成的危险。
如之前讨论的，通过以不同的角度取向沿多个纵向位置安置电极的非连续周缘治疗，可以优选影响基本上沿动脉的纵向维度延伸的解剖结构。这种解剖结构可以是神经纤维和/或支持神经纤维的结构。此外，这种不连续的周缘治疗可以减轻或减少在围绕动脉的角维度延伸的结构如平滑肌细胞中引起的潜在不期望效果。平滑肌细胞相对于动脉的有角度或周缘取向可以至少部分地解释为何连续的周缘损害可能增加急性或晚期狭窄的危险。
尽管在图2A-J中，电极元件306经由定位元件304膨胀，但是应当理解，根据本发明的可膨胀的电极元件或电极另外地或备选地可以配置用于自膨胀成与血管壁接触。例如，在移去将电极限制在减小的传递构造中的鞘或引导导管303以后，电极可以自膨胀。电极或电极元件可以例如由配置用于自膨胀的形状-记忆元件制成，或接合至配置用于自膨胀的形状-记忆元件。自膨胀实施方案可以任选通过将限制鞘或导管再安置在自膨胀元件上而折叠，以将其从患者收回。
图3示例了具有自膨胀电极元件306’的装置300的备选实施方案。已经从该装置移去的定位元件304。在使用中，装置300在鞘或引导导管303内前进到治疗部位。将鞘移去，并且元件306’自膨胀使电极307与血管壁接触。有利地，血液在治疗区TZI的形成过程中连续流过动脉A。然后可以将元件306’部分或完全地折叠(例如，在鞘303内)，有角度地相对血管旋转，横向地相对血管再安置，并且再膨胀，以与沿不同的径向平面或横截面的血管壁接触。例如，治疗可以在血流的存在下在新的位置并且以新的角度取向进行，以形成重叠治疗区TZII，所述重叠治疗区TZII在与治疗区TZI叠置时，完成不连续的周缘治疗区TZI-II。然后可以将元件306’再折叠，并且可以将装置300从患者移去，以完成该程序。
现在参考图4，可以期望的是，在没有电极或其它能量传递元件的有角度的和/或纵向的再安置的情况下，实现不连续的周缘治疗。为此目的，在另一个实施方案中，装置400包括具有可主动膨胀或自膨胀的金属丝篮404的导管402，所述可主动膨胀或自膨胀的金属丝篮404具有近侧电极406和与所述近侧电极在纵向上分开的远侧电极408。近侧电极406和远侧电极408还在金属丝篮周围径向地分开并且电连接到场发生器50(参见图2A)。近侧电极406可以沿与远侧电极不同的金属丝篮的金属丝安置。因此近侧和远侧电极有角度地并且侧向地彼此偏置。
近侧电极可以独立于远侧电极运行，和/或近侧和远侧电极可以全部以相同的极性运行，例如，作为与外部接地组合的有源电极以单极形式运行。备选地或另外地，近侧电极相互可以以双极形式使用，和/或远侧电极相互可以以双极形式使用。近侧和远侧电极优选不以双极形式一起使用。通过用远侧电极408治疗，可以在动脉周围形成图2H的治疗区TZI。用近侧电极406治疗可以产生图2I的治疗区TZII，所述治疗区TZII相对于所述治疗区TZI有角度地偏置。治疗区TZI和TZII的叠置产生在动脉的纵向节段之上的不连续的周缘治疗区TZI-II。
任选可以同时使用近侧和远侧电极，以同时形成治疗区TZI和TZII。备选地，可以以任何期望的顺序顺次运行电极，以顺次形成治疗区。作为又一个备选方案，经由同时治疗和部分地经由顺次治疗，可以部分地形成治疗区。
图5A和5B描述了在不必再安置电极或其它能量传递元件的情况下的用于不连续周缘治疗的另外的装置和方法。如在图5A和5B中看到的，装置300具有电极元件306”，所述电极元件306”包括连接到或安置在定位元件304周围的花线电路(flex circuit)。经由通过导管302或沿导管302延伸的金属丝，或通过无线方式，所述花线电路被电连接到场发生器50。在图5A中，花线电路包含在定位元件304周围的可折叠圆筒。在图5B中，花线电路包括用于每一个电极307的单独的电连接，这可以有助于花线电路的折叠以进行传递和收回。与图4的装置400的电极一样，图7的电极307在相对于定位元件和血管的多个纵向位置隔开。可以如前所述运行电极，以实现不连续的周缘治疗。由于电极307被示意性地安置在3个不同的纵向位置，因此可以例如经由3个治疗区(在血管内的每一个纵向位置)的叠置形成不连续的周缘治疗。
图2-5示意性地描述了用于没有周缘损害形成的周缘治疗的电学方法和装置。然而，应当理解，备选的能量形式，包括磁、热、化学、核/辐射、流体等，也可以用于实现没有周缘损害的期望的周缘治疗。此外，尽管图2-5示意性地包括装置的完全血管内安置，但是应当理解，任选经由血管内-至-血管外途径可以将该装置的全部或一部分安置在血管外。
在电场(或其它能量)的传递过程中，血管内的血液可以作为用于将过量的热能从非靶组织(例如血管的内壁)移去的传导和/或对流热传递的散热器(热的或冷的)，从而保护非靶组织。当血流在能量传递过程中不被阻塞时，可以增强此效果，如图3和4的实施方案中一样。预期患者血液作为散热器的使用有助于在减少对非靶组织的损伤危险的情况下的较长或较高能量治疗的传递，这可以增强在靶组织如在靶神经纤维的治疗功效。
除使用患者血液作为散热器以外或作为备选方案，可以将热流体(热的或冷的)注射到例如在一个或多个电极或其它能量传递元件上游的血管中，以移去过量的热能并保护非靶组织。热流体可以例如通过装置导管或通过引导导管注射。此外，可以在除血管以外的体腔中使用该方法，所述方法在靶组织的治疗处理过程中，使用注射的热流体将过量热能从非靶组织移去，以保护非靶组织免受热伤害。
尽管以上描述了本发明的优选示意性变化，但是对于本领域的技术人员将显然的是，在不背离本发明的情况下，可以对其进行各种变化和更改。例如，尽管在图2-4的所述实施方案中，不连续的周缘治疗是经由在2个位置的治疗的叠置实现的，但是应当理解，可以将在多于2个位置的治疗叠置以实现周缘治疗，如关于图5A和5B所述的。此外，尽管在所述实施方案中，该方法在血管中进行，但是应当理解，该治疗备选地可以在其它体腔中进行。在后附权利要求中，意欲覆盖落入本发明的精神和范围之内的所有这样的变化和更改。

Claims (25)

1.一种用于患者体腔的不连续周缘治疗的方法，所述方法包括：
至少接近所述体腔的壁安置能量传递元件；
将能量从所述能量传递元件传递至在相对于所述体腔的第一纵向位置的所述体腔的不足整个周缘，以形成第一治疗区；和
将能量从所述能量传递元件传递至在相对于所述体腔的第二纵向位置的所述体腔的不足整个周缘，以至少形成第二治疗区，其中所述第一纵向位置和所述第二纵向位置沿所述腔的纵向维度彼此分开。
2.根据权利要求1所述的方法，其中在所述第二纵向位置传递能量另外包括相对于所述患者的所述体腔再安置所述能量传递元件。
3.根据权利要求1所述的方法，其中接近所述患者的所述体腔安置所述能量传递元件另外包括接近所述患者的血管安置所述能量传递元件。
4.根据权利要求1所述的方法，其中接近所述患者的所述体腔安置所述能量传递元件另外包括在所述患者的所述体腔内安置所述能量传递元件。
5.根据权利要求4所述的方法，其中在所述患者的所述体腔内安置所述能量传递元件另外包括在所述患者的血管内安置所述能量传递元件。
6.根据权利要求5所述的方法，所述方法另外包括在所述能量传递过程中阻塞所述血管内的血流。
7.根据权利要求4所述的方法，其中在所述患者的所述体腔内安置所述能量传递元件另外包括将所述体腔的壁与所述能量传递元件接触。
8.根据权利要求4所述的方法，其中在所述患者的所述体腔内安置所述能量传递元件另外包括在所述能量传递之前，使所述能量传递元件跨越所述体腔的所述壁。
9.根据权利要求1所述的方法，其中接近所述体腔安置所述能量传递元件另外包括安置包括能量传递子元件的能量传递元件，所述能量传递子元件相对于彼此纵向地且有角度地分开。
10.根据权利要求9所述的方法，其中在所述第一和至少第二纵向位置传递能量另外包括用纵向地且有角度地分开的能量传递子元件传递能量。
11.根据权利要求10所述的方法，其中用所述能量传递子元件传递能量另外包括在所述第一和至少第二纵向位置同时传递能量。
12.根据权利要求11所述的方法，其中用所述能量传递子元件传递能量另外包括以任意期望的顺序在所述第一和至少第二纵向位置顺次传递能量。
13.根据权利要求1所述的方法，其中接近所述患者的所述体腔安置所述能量传递元件另外包括接近所述患者的多个体腔安置所述能量传递元件。
14.根据权利要求5所述的方法，其中在所述患者的所述血管内安置所述能量传递元件另外包括在所述患者的肾脉管系统内安置所述能量传递元件。
15.根据权利要求1所述的方法，其中接近所述体腔安置所述能量传递元件另外包括接近所述体腔安置至少一个电极，并且
其中用所述能量传递元件传递能量另外包括从所述至少一个电极传递电场。
16.根据权利要求15所述的方法，所述方法另外包括将外部接地附着到患者的外部，
其中所述电场的传递另外包括在所述至少一个电极和所述外部接地之间以单极方式传递所述电场。
17.用于患者体腔的不连续周缘治疗的装置，所述装置包括：
配置为接近所述体腔安置的器件；
连接到所述装置的第一能量传递元件；和
连接到所述装置的第二能量传递元件，
其中所述第一能量传递元件和所述第二能量传递元件在所述器件的长度周围纵向地且有角度地彼此偏置分开，
其中所述第一能量传递元件和所述第二能量传递元件中的每一个配置为将能量传递至所述患者的所述体腔的不足整个周缘。
18.根据权利要求17所述的装置，其中所述器件包括配置为安置在所述体腔内的导管，并且
其中所述第一能量传递元件和所述第二能量传递元件被连接到可膨胀元件，所述可膨胀元件配置为使所述第一能量传递元件和所述第二能量传递元件与所述体腔的壁接触。
19.根据权利要求18所述的装置，其中所述可膨胀元件配置为在能量传递过程中阻塞所述体腔内的流体流动。
20.根据权利要求17所述的装置，其中所述器件包括配置为安置在所述体腔内的导管，并且
其中所述第一能量传递元件和所述至少第二能量传递元件配置为跨越所述体腔的壁。
21.根据权利要求17所述的装置，所述装置另外包括至少一个传感器，所述至少一个传感器配置为监控所述装置或所述患者内的组织的参数。
22.根据权利要求21所述的装置，所述装置另外包括反馈控制系统，所述反馈控制系统配置为响应于监控到的参数而改变治疗。
23.一种治疗用方法，所述方法包括：
在相对于患者体腔的第一纵向且有角度的位置安置能量传递元件；
将能量从所述能量传递元件传递至在所述第一纵向且有角度的位置的所述体腔的不足整个周缘，以形成第一治疗区；
将所述能量传递元件再安置到相对于所述体腔的第二纵向且有角度的位置，所述第二纵向且有角度的位置与所述第一纵向且有角度的位置不同；和
将能量从所述能量传递元件传递至在所述第二纵向且有角度的位置的所述体腔的不足整个周缘，以形成第二治疗区。
24.根据权利要求23所述的方法，其中经由所述第一治疗区和所述第二治疗区的叠置形成的复合治疗区包括不连续的、完全周缘的治疗区。
25.一种治疗患者的方法，所述方法包括：
将能量传递到在体腔的内壁的第一治疗区并且传递到在所述腔的所述壁的第二治疗区，其中所述第一治疗区在径向平面具有离散的、非连续的第一损害，而所述第二治疗区在与所述第一径向平面分开的第二径向平面具有离散的、非连续的第二损害，并且
影响在所述体腔内壁外的神经组织。
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US9757193B2 (en) 2017-09-12

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