CN105682594B - 螺旋双极电极肾脏去神经支配气囊 - Google Patents
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Abstract
一种肾神经消融装置可以包括具有远端区域的细长管形件。可以连接到所述远端区域的可扩张件。一个以上的有源电极可以连接到所述可扩张件。一个以上的接地电极可以连接到所述可扩张件。所述一个以上的有源电极和/或所述一个以上的接地电极可以围绕所述可扩张件的所述长度为螺旋定向。
Description
相关申请的交叉引用
根据《美国法典》35卷§119,本申请要求于2013年7月19日提交的美国临时申请序号第61/856,523号的优先权,其全部内容通过引用合并在此。
技术领域
本发明涉及医疗器械,及使用和制造医疗器械的方法。更特别地,本发明涉及用于肾神经消融的医疗器械。
背景技术
已研发出各种体内医疗器械为医疗所用,例如,血管内使用。这些器械中的一些包括导丝、导管等。这些器械通过各种不同制造方法中的任一种来制造,并可根据各种方法中的任一种使用。在已知的医疗器械和方法中,各具有某些利弊。需要不断地提供替代的医疗器械及制造和使用医疗器械的替代方法。
发明内容
一种肾神经消融装置可以包括具有远端区域的细长管形件,连接到所述远端区域的可扩张件,所述可扩张件具有长度,连接到所述可扩张件的一个以上的有源电极,连接到所述可扩张件与所述一个以上有源电极相邻的一个以上的接地电极,一个以上的温度传感器,布置在所述可扩张件的外表面上与所述一个以上的有源电极和所述一个以上的接地电极相邻,其中所述一个以上的有源电极和所述一个以上的接地电极围绕所述可扩张件螺旋定向。
一种肾神经消融装置可以包括具有远端区域的细长管形件,可扩张球囊连接到所述远端区域,所述可扩张球囊具有长度,多个螺旋定向的有源电极连接到所述球囊,多个螺旋定向的接地电极连接到所述球囊,并且多个温度传感器布置在所述球囊的外表面上,在所述多个螺旋定向的有源电极和所述多个螺旋定向的接地电极之间。
一种肾神经消融装置可以包括具有远端区域的细长管形件,可扩张球囊连接到所述远端区域,所述可扩张球囊具有长度,连接到所述球囊的柔性聚合物片,其中所述柔性聚合物片包括螺旋定向的有源电极、螺旋定向的接地电极以及温度传感器,所述有源电极在所述柔性聚合物片的背离所述球囊的表面上,所述接地电极在所述柔性聚合物片的背离所述球囊的表面上相邻所述有源电极布置,,所述温度传感器在所述螺旋定向的有源电极和所述螺旋定向的接地电极之间,所述温度传感器在所述柔性聚合物片面朝所述球囊的表面上。
一种消融肾神经的方法可以包括步骤:
提供一种肾神经消融装置,所述肾神经消融装置包括具有远端区域的细长管形件,连接到所述远端区域的可扩张件,所述可扩张件具有长度,连接到所述可扩张件的一个以上的有源电极,连接到所述可扩张件与所述一个以上有源电极相邻的一个以上的接地电极,以及布置在所述可扩张件的外表面上与所述一个以上的有源电极和所述一个以上的接地电极相邻的一个以上温度传感器,其中所述一个以上的有源电极和所述一个以上的接地电极围绕所述可扩张件为螺旋定向;
使肾神经消融装置前进穿过血管到达肾动脉内的位置;
扩张所述可扩张件;以及
激活所述一个以上有源电极中的至少一个。
上文一些实施例的内容不打算对本发明的每个公开的实施例或者每个实施方式进行描述。其后的附图以及详细的说明尤其特别地例证了这些实施例。
附图说明
本发明可以考虑通过以下的具体实施方式结合附图的方式进行更加全面的理解,所述附图中:
图1为示例性的肾神经消融装置的示意图;
图2为示例性的肾神经消融装置的可扩张件的立体图;
图3为处于展开形态或平面形态的图2的可扩张件的局部俯视图;
图4为部分示例性的电极组件的俯视图;图5为图4的局部截面视图A‐A;
图6为图4的局部截面视图B‐B;
图7为示例性的可扩张件的局部侧视图;
图8为示例性的可扩张件的局部侧视图;
图9为示例性的可扩张件的局部侧视图;并且
图10为示例性的可扩张件的局部侧视图;
尽管本发明可以进行各种修改以及采用各种替代形式,但其细节已经通过示例在附图中示出并且将被详细描述。然而,应该理解的是,本发明的目的不是将本发明限制于所描述的特定实施例。相反,其目的是覆盖落入本发明的精神和范围内的所有修改,等同物和替代方案。
具体实施方式
以下说明应当参照附图来阅读,附图不必成比例,其中在全部附图中,相同的附图标记表示相同的元件。具体实施方式和附图旨在说明,而非限制请求保护的本发明。本领域技术人员应当意识到,在不脱离本发明范围的情况下,描述和/或示出的各种元件可以以各种组合和构造布置。具体实施方式和附图说明了请求保护的本发明的示范实施方式。
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。术语“大约”的其他使用(即,在除了数值之外的情况下),可假定具有它们通常且常规的定义,根据说明书语境理解并与说明书的语境相一致,除非另外说明。
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”和“该”包括复数指代,除非文中清楚地表明并非如此。如在本说明书和所附权利要求中所使用的,术语“或者”通常使用其包括“和/或”的含义,除非文中清楚地表明并非如此。
应当注意到,在本说明书中提及“一实施方式”,“一些实施方式”,“其他实施方式”等表明描述的该实施方式可包括特定的特征,结构,或特性,但不必每个实施方式都包括该特定的特征,结构,或特性。此外,这种短语不必指代同一实施方式。而且,当在一实施方式中描述特定的特征,结构,或特性时,本领域技术人员应当理解,不论是否明确描述,这种特征,结构,和/或特性也可用于其他实施方式中,除非清楚地表明相反。即,以下描述的各种单个的元件,即使没有以特定组合明确示出,虽然如此,可以预期,其可相互结合或设置以形成其他的附加实施方式或者补充和/或充实描述的实施方式,如本领域技术人员理解的。
某些治疗旨在暂时或永久中断或者改变选择的神经功能。一个示范治疗是肾神经消融,其有时用来治疗诸如高血压、充血性心力衰竭、糖尿病或与高血压、充血性心力衰竭、糖尿病有关的状况,或其他受高血压或盐滞留影响的状况。肾脏产生交感神经响应,其可增加水和/或钠不期望的滞留。交感神经响应的结果可能,例如,增加血压。对一些延伸到肾脏的神经(例如,邻近肾动脉设置或以其他方式沿肾动脉设置)的消融可减少或消除这种交感神经响应,这可促进相关联的不期望的症状相应减轻(例如,血压降低)。
本发明的一些实施方式涉及能量生成和控制装置,通常用于靶组织的治疗以实现治疗效果。在一些实施方式中,靶组织是包含神经或接近神经的组织,包括肾动脉和关联的肾神经。在其他实施方式中,目标组织是腔组织,其可进一步包括诸如在动脉疾病中发现的病变组织。
在本发明一些实施方式中,按目标剂量传送能量的能力可用于神经组织以实现有益的生物响应。例如,已知慢性疼痛、泌尿障碍、高血压、以及许多其他的持续性状况通过神经组织手术而受到影响。例如,已知,可能不对药物响应的慢性高血压可通过使接近肾动脉的过多神经活动失效而得到改善或者根除。因此,通过破坏神经组织的传导路径能够有益地影响过多的神经活动。破坏神经传导路径时,避免对周围神经或器官组织造成损伤是特别有利的。指引并控制能量剂量的能力非常适合于神经组织的治疗。无论是以加热能量剂量或是消融能量剂量,如本文中描述并披露的能量传送的精确控制可指向神经组织。此外,能量的定向应用可足够瞄准神经,而无需如使用典型的消融探针时所需要的准确接触。例如,可以以很高的、足以使神经组织变性的温度施加偏心(eccentric)加热,而不会导致消融,并且无需刺穿腔组织。然而,本发明也希望配置能量传送表面来刺穿组织,并且用精确的能量剂量像消融探针那样传送消融能量,所述能量剂量由能量控制和生成装置进行控制。
在一些实施方式中,去神经治疗的疗效可通过治疗前,治疗中,和/或治疗后测量来评估以对特定患者定制一个或多个治疗参数或者识别是否需要附加治疗。例如,去神经系统可包括用于评估治疗是否已经导致或者正在导致靶组织或邻近组织中神经活动的减少,这可为调节治疗参数提供反馈或者表明附加治疗的必要性。
虽然关于肾神经消融和/或调制讨论了本文描述的装置和方法,可以预期,该装置和方法可用于期望进行神经调制和/或其他组织调制的其他治疗位置和/或应用,包括加热、激活、阻断、破坏、或消融,诸如但不限于:血管、泌尿管、或经由套针和插管进入的其他组织中。例如,本文描述的装置和方法可用于增生组织消融、心脏消融、肺静脉隔离、肺静脉消融、肿瘤消融、良性前列腺增生治疗、神经激发或阻断或消融、肌肉活动调制、组织热疗或其他加热等。
图1是示范肾神经消融系统100的示意图。系统100可包括肾神经消融装置120。肾神经消融装置120可用来消融邻近肾脏K的神经(例如,肾神经,例如,肾动脉RA周围的肾神经)。使用中,肾神经消融装置120可前进穿过诸如主动脉A的血管至肾动脉RA内的位置处。这可包括推进肾神经消融装置120穿过引导鞘套或导管14。当依照要求定位好时,可激活肾神经消融装置120以激活一个或多个电极(未示出)。这可包括可操作地连接肾神经消融装置120至控制单元110,控制单元110可包括射频(RF)发生器,以便供给期望的激活能量至电极。例如,肾神经消融装置120可包括具有连接器20的线或传导部件18,连接器20可连接至控制单元110上的连接器22和/或连结至控制单元110的线24。在至少一些实施方式中,控制单元110还可用来供给/接收适当的电能和/或信号以激活一个或多个设置在肾神经消融装置120远端或远端附近的传感器。当适当地激活时,如以下描述的,电极能够消融组织(例如,肾神经),并且传感器可用来检测期望的物理和/或生物参数。
可与本文所公开的实施例一起使用的示例性的控制单元110和关联的能量传送方法,在公开号为2012/0095461、题为“用于组织治疗的能量生成和控制装置”的美国专利申请中公开,其全部内容通过引用并入到本文中。可与本文所公开的实施例一起使用的进一步的实施例在专利号为7,742,795、题为“粥样斑以及其他目标组织和/或结构的选择性治疗的调谐RF能量”的美国专利,专利号为7,291,146、题为“动脉粥样硬化材料的可选择偏心重构和/或消融”的美国专利,以及公开号为2008/0188912、题为“在身体组织上引起期望温度效应的系统”的美国专利申请中公开,其全部内容通过引用并入到本文中。在一些实施例中,特别在一些使用单极能量传送的实施例中,系统100也可以包括接地/公共电极(未示出),所述电极可与消融装置120相关联。接地/公共电极可以是独立的电极片,该电极片电连接或者用别的方法可操作地连接到控制单元110,或者用别的方法与系统100相关联。
在一些实施例中,控制单元110可以包括处理器或者用别的方法连接到处理器,来控制治疗或者对治疗进行记录。处理器通常包括计算机硬件和/或软件,经常包括一个以上可编程处理器单元,这些单元运行机器可读程序指令或代码,以执行本文所描述的一个以上实施例和方法中的一些或全部。代码可以经常收录在有形介质中,例如存储器(可选择只读存储器、随机存取存储器、非易失性存储器等)和/或记录介质(例如软盘、硬盘驱动器、CD、DVD、或者其他光学介质、非易失性固态存储卡等)。代码和/或相关的数据与信号也可以通过网络连接(例如无线网络、以太网络、互联网、内网等)传输到处理器或者从处理器传输,并且代码中的一些或者全部也可以通过一条以上的总线在肾神经消融系统的元件之间和处理器内部传输,并且处理器中经常包括合适的标准或者专有的通讯卡,连接器,电缆等。处理器通常可配置成至少部分通过用软件代码编程处理器来执行本文描述的计算及信号传输步骤,其可写成单个程序、一系列单独的子程序或相关程序等。处理器可以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,并且其具有所需的足够处理能力,在病人的治疗过程中执行本文所描述的计算,所述处理器可选择地包括个人计算机、笔记本电脑、平板计算机、专有处理单元或者它们的组合。也可以包括与现代计算机系统相关联的标准或专有的输入装置(例如鼠标,键盘,触摸屏,操纵杆等)和输出装置(例如打印机,扬声器,显示器等),并且可以将具有多个处理单元的处理器(甚至单独的计算机)在广泛的集中式或分布式数据处理架构中使用。
在一些实施例中,系统100的控制软件可以使用客户端‐服务器方案来进一步加强系统的方便使用、灵活性和可靠性。“客户端”可以是系统控制逻辑;“服务器”可以是控制硬件。通信管理器可以将系统状态上的变化传送给预订的客户端和服务器。客户端可以“知道”目前的系统状态是什么,并且基于状态上具体的变化,所要执行的命令或决定是什么。服务器可以基于客户端命令来执行系统功能。因为通信管理器可以是集中信息管理器,新的系统硬件可以不要求改变在先已存在的客户端‐服务器关系;接着新的系统硬件及其相关的控制逻辑仅仅成为了通过通信管理器所管理信息的另外的“预订者”。该控制方案的优势在于具有稳健的中央操作程序,所述中央操作程序具有固定的基本例程;不需要为了运行新的电路元件(被设计成与系统一起运行)而改变基本例程。
在一些实施例中,肾神经消融装置120可以包括细长的管形件或者导管轴122。在一些实施例中,所述细长的管形件或者导管轴122可以配置成沿导丝或者其他细长的医疗装置滑动前进至目标位置。在一些实施例中,所述细长的管形件或者导管轴122可以配置成在引导护套或者导管14内滑动前进至目标位置。在一些实施例中,所述细长的管形件或者导管轴122可以配置成沿导丝、在引导护套或者导管14内或者以它们结合的方式前进至目标位置。
可扩张件130可以布置在细长管形件或者导管轴122的远端中、远端上、远端周围或远端附近。在一些实施例中,可扩张件130可以固定附接至细长的管形件或者导管轴122。在一些实施例中,可扩张件130可以从塌缩输送状态自扩张到扩张状态,所述可扩张件130可以是诸如,例如篮状物,可膨胀的泡沫或其它材料,或者多个支杆。在一些实施例中,可扩张件130可选择地从塌缩输送状态扩张到扩张状态,所述可扩张件130可以是顺应性、非顺应性、半顺应性的球囊。在一些实施例中,一个以上的电极可以设置在可扩张件130的外表面上,或者设置在其周围,或者连接到外表面。在一些实施例中,所述一个以上的电极可以可操作地并且/或者电连接到控制单元110和/或RF生成器。在一些实施例中,所述一个以上的电极可以包括多个电极组件。在一些实施例中,所述多个电极组件中的一个以上可以配置成单极或者双极,并且可以进一步包括温度传感器,例如热敏电阻或热电偶。
例如,如图2中所示,电极组件可以按照多个大体柱状的治疗区A‐D布置在可扩张件130上,图中所示的可扩张件130处在扩张状态。在其他的实施例中,可扩张件130或者治疗系统的其他元件可以包括另外的电极组件,这些组件不在治疗区域,或者不用来或配置用来传送治疗能量。
图3中进一步示出了治疗区域A‐D以及相关联的电极组件140a‐d,图3是图2可扩张件130一部分的“展开”图。在一些实施例中,可扩张件可以是具有4mm直径并且带有两个电极组件140a‐b的球囊。在其他的实施例中,可扩张件可以是具有5mm直径并且带有三个电极组件140a‐c的球囊。如图2中所描绘的,在一些实施例中,可扩张件可以是具有6、7或8mm直径并且带有四个电极组件140a‐d的球囊。对于这些形态中的任意一种,可扩张件可以具有大约10mm到大约100mm,或者大约18mm到大约25mm的工作长度,这些工作长度可以是图2和3中所示全部治疗区域A‐D的近似纵向跨度。电极组件140a‐d可以使用粘合剂或者其他合适的手段附接到球囊。
回到图2,治疗区域A‐D可以沿纵轴L‐L彼此纵向相邻,并且可以对其进行配置,使得电极组件施加的能量产生不重叠的治疗。由纵向相邻的双极电极组件140a‐d所施加的治疗可以是沿纵轴L‐L周向非连续的。例如,参照图3,在一些实施例中,最小化治疗区域A内所产生的毁损灶(lesion)与治疗区域B内所产生的毁损灶(lesion)围绕圆周(视图中,相对于L‐L是横向的)的重叠。然而,在其他的实施例中,电极组件(诸如图3中所示的电极组件)施加的能量,至少在一定程度上可以纵向、周向以及/或者以其他的方式重叠。
电极/电极对之间的治疗区域会否重叠受到各种因素的影响,包括但不限于电极的几何形状,电极放置密度,电极定位,接地/公共电极(多个)的位置和几何形状(在单极实施例中),能量发生器输出设置,输出电压,输出功率,占空比,输出频率,组织特性,组织类型等。在一些实施例中,每个双极电极对中单个的电极各自界定自己的治疗区域,并且这些治疗区域可以部分或者全部地重叠。在一些实施例中,重叠的治疗区域可以围绕可扩张件的圆周,并且/或者围绕环绕身体通道的组织上的圆周基本上连续地延伸。在其他的实施例中,尽管有重叠的治疗区域,但是该重叠可能基本上围绕圆周不连续,并且治疗区域上可能存在明显的间断。
回到图3,每个电极片组件可能包括四个主要的元件,这些元件为远侧电极片150a‐d、中间尾部160a‐d、近侧电极片170a‐d和近侧尾部180b、d(未示出电极片组件140a和140c的近端尾部)。示出了电极组件140a‐d的结构细节,并且参照图4‐6进行了描述。
图4示出了电极组件200的俯视图,在图3中标识为电极组件140。可以将电极组件200构造成具有多层的柔性电路。这些层可以是连续的,也可以是非连续的(例如,由离散部分组成)。如图5和6中所示,绝缘的基层202可以为电极组件200提供基础。基层202可以由柔性聚合物(例如聚酰亚胺)构成,当然也可以考虑其他材料。在一些实施例中,基层202的厚度可以从大约0.005mm到大约0.04mm。在一些实施例中,基层202可以为大约0.5mil(0.0127mm)厚。由多条离散迹线组成的导电层204可层叠在基层202的顶部。导电层204可以是,例如,电沉积铜的层。也可以考虑其他材料。在一些实施例中,导电层204的厚度可以从大约0.005mm到大约0.04mm。在一些实施例中,导电层204可以大约0.5mil(0.0127mm)厚。绝缘层206可以离散地或者连续地层叠在导电层204的顶部,使得导电层204可以流体密封在基层202和绝缘层206之间。和基层202一样,绝缘层206可以由柔性聚合物(例如聚酰亚胺)构成,当然也可以考虑其他材料。在一些实施例中,绝缘层206的厚度可以从大约0.005mm到大约0.04mm。在一些实施例中,绝缘层206可以大约0.5mil(0.0127mm)厚。在其他实施例中,绝缘层206可以是完全或部分的聚合物涂层,例如PTFE或硅酮。也可以考虑其他材料。
图4中所示的电极组件200可以包括远侧电极片208。在该区域,基层202可以形成为矩形的形状。这并不是要进行限制性。可以考虑其它形状。如图所示,电极组件200可以包括多个开口,以提供附加的柔性,并且电极片和组件的其它部分可以包括圆形或者弯曲的角,过渡部分和其他部分。在一些例子中,开口和圆形/弯曲的特征使得组件防止从其可扩张装置分层的能力得到加强,正如在一些实施例中可能发生的,当可扩张装置重复扩张和塌缩(这也是可扩张装置从保护鞘套中展开和缩回到保护鞘套中所必需的)时,正如当手术中治疗多个位置时所需要的。
远侧电极片208可以包括多条层叠在基层202顶部的离散迹线。这些迹线可以包括接地迹线210,有源电极迹线212和传感器迹线214。接地迹线210可以包括横向从传感器接地片218偏移的细长的电极支撑216。传感器接地片218可电耦合到接地迹线210的细长的支撑216,并且可以中心定位在远侧电极片208上。桥接部220可以将传感器接地片218最远端部分连接到接地迹线210的细长电极支撑216的远侧部分。桥接部220的宽度可以在其行至传感器接地片218的过程中逐渐减小。在一些实施例中,桥接部220可具有相对均匀且薄的宽度,以实现所需柔性度。在细长电极支撑216的近端,其宽度可以逐步减小,然而这不是必须的。在一些实施例中,细长的电极支撑216在其近侧部可以突然过渡到薄得多的迹线,以实现所需柔性度。通常,可以优化示出颈缩处的迹线的曲率,以减少球囊收回力和锐利轮廓的存在出现挂住的可能。也可以优化迹线的形状和位置,以提供作为整体的电极组件200的尺寸稳定性,以防止放置和使用过程中的变形。
图4的接地迹线210和有源电极迹线212可以采用相似的结构。有源电极迹线212也可以包括细长的电极支撑216。
图5示出了远侧电极片208的部分截面A‐A。示出电极222层叠在绝缘层206的一部分上,所述绝缘层206具有多条通道(例如,孔),使得电极222能够耦合到接地迹线210(导电层204的)的细长的电极支撑216。
如图4中所示,接地迹线210和有源电极迹线212可以包括多个电极。可以给每个电极迹线提供三个电极222,然而也可以使用更多或更少的电极。另外,每个电极222可以具有倒圆角,以减少挂在其他装置和/或组织上的可能性。尽管上文对于电极222和与其相关联的迹线的描述是在双极电极组件的背景下进行的,本领域的技术人员能够认识到,相同的电极组件也可以在单极模式中起作用。例如,作为一个非限制性的例子,与有源电极迹线212和242相关联的电极可以被用作单极电极,而在这些电极通电期间接地迹线210断开。
在一些实施例中,例如图4中所示,每个电极222可以约为1.14mm乘0.38mm,同时大约0.31mm的间隙位于电极222之间。接地迹线210和有源电极迹线212的电极222可以横向间隔开大约1.85mm。在一些实施例中,例如图5中所示,电极222可以是始于导电层204的大约0.038毫米厚的金片,并且可以在绝缘层206上突出大约0.025mm。在不限制使用其它合适材料的前提下,金可以是一种良好的电极材料,因为它是生物相容的,不透射线的,以及导电和导热的。在其他的实施例中,导电层204的电极厚度范围可以从大约0.030mm到大约0.051mm。以这种厚度,如与例如铜的导电层204所比较,电极222的相对刚度是高的。因为这一点,使用多个电极与单个电极相比,可以增加柔性。在其他的实施例中,对于电极222,电极小至大约0.5mm乘以大约0.2mm或大至大约2.2mm乘以大约0.6mm。
尽管平衡绝缘层206上金的厚度是一个重要的设计优化考虑,以便实现良好的柔性同时维持其足够的高度以便提供良好的组织接触,但是这可能与在球囊布置或塌缩过程中避免可能引起挂住的表面高度的目标相抵消。这些问题可能根据特定手术的其他要素,例如球囊的压力而变化。对于许多实施例来说,已确定在绝缘层206上突出大约0.025mm的电极,在球囊膨胀压力低于10atm和低至0.5atm时,具有良好的组织接触。这些压力可以远低于血管成形术球囊通常的膨胀压力。
传感器迹线214可以定位在远侧电极片208的中心,并且可以包括面对传感器接地片218的传感器电源片224。这些片可以连接到温度传感器226的电源极和接地极,所述温度传感器诸如热电偶(例如,T型形态:铜/康铜)或者热敏电阻,如图6所描绘的局部截面中所示。
温度传感器226可以在近侧连接到传感器电源片224,并且可以在远侧连接到传感器接地片218。为了帮助减少总厚度,温度传感器226可以位于基层202内的开口内。在一些实施例中,温度传感器226可以是具有大约0.1mm厚度的热敏电阻,该厚度非常薄‐大约是行业标准的三分之二。如图所示,温度传感器226可以是在远侧电极片208的非组织接触侧。因此,当装入最终的装置(例如导管120)时,温度传感器226可以俘获在电极结构和球囊之间。这可能是具有优势的,因为表面安装的电气元件,例如热敏电阻,通常具有尖锐的边角,这些尖锐的边角可能勾到组织,并且在球囊展开和/或缩回中可能产生问题。这种安排也可阻止焊接头接触血液,因为焊料通常是非生物相容的。此外,由于温度传感器的放置,它可以测量组织和电极222的温度表示。
从远侧电极片208开始,结合的基层202、导电层204和绝缘层206可在横向宽度上减小至中间尾部228。这里,所形成的导电层204可以包括中间接地线230、中间有源电极线232和中间传感器线234,这些线分别是远侧电极片208的接地迹线210、有源电极迹线212和传感器迹线214的共同延伸的迹线。
从中间尾部228开始,结合的基层202、导电层204和绝缘层206可以在横向宽度上增加以形成近侧电极片236。近侧电极片236的构造可以与远侧电极片208类似,具有基本上相同的电极几何形状和温度传感器布置,但也可能存在各种差异。然而,如图所示,近侧电极片236可以相对于沿中间接地线230延伸的中心轴线G‐G自远侧电极片208横向偏移。中间有源电极线232和中间传感器线234可以与近侧电极片236一起在各自平行于中心轴G‐G的轴线上横向共同延伸。
从近侧电极片236开始,结合的基层202、导电层204和绝缘层206可在横向宽度上减小以形成近侧尾部238。近侧尾部238可以包括近侧接地线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可以包括连接器(未示出),能够连接到一个以上子线束和/或连接器,并且最终连接到控制单元110。这些线中的每一条可以沿各自平行于中心轴线G‐G的轴线延伸。
如图所示,电极组件200的远侧电极片208和近侧电极片236关于轴线G‐G非对称布置。进一步地,两个电极片的接地电极与中间和近侧接地线230/240一起可沿轴线G‐G大致对齐。已经发现,这种安排可能存在某些优势。例如,通过基本上共用相同的接地迹线,近侧尾部的宽度可以仅仅是中间尾部228的大约1.5倍,而不是每个电极片具有独立接地线情况下的大约两倍宽。因此,近侧尾部238比两个中间尾部228窄。
进一步地,安排电极片共用接地迹线可以使得电极彼此相互作用的控制成为可能。当观察一个电极组件时,这可能不会立即显现出来,但是例如图2‐3中所示,当多于一个的电极组件200组装在可膨胀部件(例如球囊)上时,这可能变得明显。可以使用固态继电器和多路复用的方式激发和控制多个电极片,激发时间的范围从大约100微秒到大约200毫秒或者从大约10毫秒到大约50毫秒。为了实用的目的,电极片可以表现为同时激发,然而微爆(micro burst)中的电极快速激发可以防止不同电极组件200的相邻电极片之间的杂散电流。这可以被执行,使得不同电极组件200的相邻电极片彼此异相激发。因此,电极组件的电极片布置可以允许短的治疗时间‐大约10分钟或者更少的总电极激发时间,一些近似的治疗时间短至大约10秒,示例性实施例为大约30秒。短的治疗时间的一些益处可以包括当神经组织受到能量治疗时,使手术和所引起的术后疼痛最小化,缩短血管闭塞时间,降低闭塞副作用,并且由于对于管腔组织相对较小的热输入,通过血流灌注快速冷却侧支组织。
在一些实施例中,公共接地通常传输来自负电极的500kHz的200VAC,以及来自温度传感器226(在热敏电阻的情况下)的1V信号,该信号可能需要RF电路的滤波,使得热敏电阻的信号可以被检测并且用于发生器控制。在一些实施例中,因为公共接地,可以用相邻电极对的热敏电阻来监视温度,即使没有激发相邻的电极对。这提供了在仅激发远侧电极片208和近侧电极片236中的一个时,检测两者附近温度的可能性。
再次参照图3,每个电极组件140a‐d的电极片的布置也实现了可扩张件130上的有效放置。如图所示,电极组件140a‐d可以“嵌”入到彼此以能够最大化使用可扩张件的表面区域。通过设定每个中间尾部的纵向长度来将电极片分开可以部分实现该布置。例如,可以将电极组件140a的中间尾部的长度设定为一段将其远端和近端电极片150a、170a分开的距离,使得横向相邻电极组件140b的横向相邻近侧电极片170b紧挨着电极组件140A的中间尾部160a嵌入。进一步地,电极组件140a的远侧电极片150a可以嵌在电极组件140b的中间尾部160b和电极组件140d的中间尾部160d之间。因此,每一个中间尾部160a‐d的长度也可能要求任何一个电极组件的每一个电极片位于非相邻的治疗区域。
可扩张件或球囊表面面积最大化,也可以部分通过横向偏移每个电极组件140a‐d中的两个电极片来实现。例如,每个远侧电极片150a‐d的向右横向偏移和近侧电极片170a‐d的向左横向偏移,允许相邻的电极片组件嵌入到彼此,使得电极片中的一些可以彼此横向重叠。例如,电极组件140a的远侧电极片150a可以与电极组件140b的近侧电极片170b横向重叠。进一步地,电极组件140b的远侧电极片150b可以与电极组件140c的近侧电极片170c横向重叠。然而,每个中间尾部的长度可以防止电极片的圆周重叠(此视图中的纵向重叠),从而维持了治疗区域沿纵向方向L‐L的非连续的性质。
电极片的布置和几何形状,以及柔性电路尾部的布置和几何形状,也可以有利于将球囊折叠或以其他的方式塌缩成相对紧凑的未扩张状态。例如,在扩张直径达到大约10mm实施例中,处于未扩张状态的装置可以具有低至大约1mm的直径。
一些实施例可以利用具有相同尺寸和结构的标准电极组件,其中可扩张件或球囊外表面上电极组件的数量和相对位置成为可扩张件或球囊直径和/或长度的函数,但是在各种尺寸的可扩张件或球囊中,电极组件的几何形状保持不变。电极组件相对于可扩张件或球囊直径和/或长度的相对定位,接着可由既定尺寸的可扩张件或球囊上的邻近电极组件的相邻电极片的周向和/或轴向重叠所需的程度或避免来确定。然而在其他实施例中,可扩张件或球囊上的所有电极组件可能不必是相同的。
可以根据本发明的一个非限制性实施例使用系统100来实施治疗的方法。例如,控制单元110可以可操作地连接到消融装置120,可以将所述消融装置120插入到身体通道,使得可扩张件130(具有多个电极组件)可以邻近需要治疗的身体通道的第一部分放置。在需要治疗的身体通道的第一部分放置消融装置120,可以按照现有的方法实施,例如,在荧光镜引导下沿导丝进行。一旦插入,可以使得可扩张件130从塌缩输送形态扩张到扩张形态,例如在球囊的情况下,通过加压大约2‐10atm的流体。这可以使得可扩张件130的电极和/或电极组件身体通道的第一部分形成接触。
在一些实施方案中,控制单元110可以测量电极组件处的阻抗,以确认电极与身体通道的并置。在至少一些实施例中,即使未检测到所有电极的并置,治疗也可以继续进行。例如,在一些实施例中,如果检测到50%以上电极的对置,治疗就可以继续进行,并且可以允许在周向上或者轴向上不是完全均匀的并置。例如,在一些实施例中,可以定位导管使得一个以上的近侧电极在主动脉A中并且暴露于血液,而这些电极所感测到的阻抗未落入预先指定的范围内(如,例如,500‐1600ohms),则表明那些电极缺少组织并置。在一些实施例中,即使没有均匀的电极/组织并置,该系统也可以授权用户继续进行治疗。随后,控制单元110可以激活电极以产生相应数量的毁损灶。在电极的激活过程中,控制单元110可以使用电极片的温度传感器来监视电极和/或组织的热量。以这种方式,在治疗过程中更多或者更少的能量可以根据需要供应给每个电极片。
在这些实施例中,控制单元110可以应用统一的标准,用于确定对消融装置120的所有电极的并置。例如,控制单元110可以将相同的预先指定的电阻测量范围使用到所有的电极。然而,在其他的例子中,包括一些单极应用(尽管不是全部的),不同的标准可以应用到不同的单极电极,用来确定并置。例如,在一些单极的实施例中,每个单极电极可以界定穿过组织到达公共/中性电极(或多个电极)的离散电路,并且那些电路(例如电阻)的特性可以基于单极电极和公共电极之间的距离、它们之间的组织特性,以及装置和周围组织的其他几何形状和特性而显著不同。如此,在至少一些实施例中,可能需要应用标准来确定根据,例如,单极电极和公共接地电极之间距离变化的并置(例如:两个电极之间的距离越大,就需要越高的阻抗测量来确定良好的并置)。然而在其他的实施例中,由于这些距离和其它几何形状上的差异所引起的变化可以是最小的或者非实质性的,并且可以使用统一的标准。
在身体通道的第一部分上所指定的治疗完成之后,可扩张件130可接着塌缩并且移动到需要治疗而未治疗的身体通道的第二部分,以重复施加在身体通道的第一部分上的治疗,并且其他部分根据需要也可以采用类似的方法。这些部分可以是直接相邻的,也可以是分离或者间隔一段距离的。
在一些实施例中,可以使用替代的方法。例如,在一些实施例中,可以仅在身体通道的一个位置实施治疗,而不需要移动可扩张件到身体通道中的多个位置。
参照涉及肾性高血压的例子,肾性高血压涉及到减少过度的神经活动,系统100的使用实现了一种非穿孔、非消融的方式来影响神经活动。因此,身体通道可以是神经组织包围的肾动脉。可以给可扩张件130上的电极供电,以朝着所要影响的神经的已知方向输送能量,能量渗透的深度为电量、电极类型(例如,单极相对双极)以及电极的几何形状的函数。公开号为2008/0188912,题为“在身体组织上诱导所需要温度效应的系统”的专利申请,通过引用其全部并入到本文中,该专利申请描述了对电极几何形状和组织治疗区域体积的考虑,尽管不需要全部,一些实施例可以考虑这些描述。在一些例子中,可以用经验分析来确定神经组织的阻抗特性,使得消融装置120可以用于首先特征化,接着以针对性的方式治疗组织。能量的输送和调节也可能进一步涉及累积损伤建模。
如图所示,每个毁损灶可以产生在可扩张件130相应的治疗区域A‐D。因此,在一个特定治疗区域A‐D中所生成的任何毁损灶,可不与相邻治疗区域A‐D的毁损灶沿纵轴线L‐L在任何点周向重叠。在一些实施例中,可扩张件130的治疗区域可以具有多于一个的电极片,因此在这些例子中,由那些电极片所产生的毁损灶可以周向重叠。在那些例子中,特定的身体结构可能需要更多的毁损灶,或者治疗实施前所执行的常规诊断需要电极对。无论如何,相邻治疗区域电极的周向重叠可以不存在。
根据所要求的特定重建效果,控制单元可以用大约0.25到大约5Watts的平均功率给电极通电大约1到大约180秒,或者用大约0.25到大约900焦耳通电。可以以更低的功率和更长的持续时间进行更高能量的治疗,例如0.5Watts90秒或者0.25Watts180秒。在单极的实施例中,取决于电极形态和电极与公共接地之间的距离,控制单元可以用高达30Watts的功率给电极通电长达5分钟。较短的距离可以提供较低的能量以及较短的时间段,因为能量在更加集中的区域上传输,伴随着更加少的导电损耗。在用于肾脏去神经支配术的示例实施例中,能量可0以以大约5Watts的治疗设定传输大约30秒,使得治疗区域在治疗过程中可以加热到大约68℃。如上所述,功率要求可能在很大程度上取决于电极类型和形态。通常,伴随着更加宽的电极间距,可以要求更加大的功率,在这种情况下,平均功率能够高于5Watts,而总能量可能超过45焦耳。同样地,使用更加短或者更加小的电极对,可能需要按比例缩小平均功率,并且总能量可能小于4焦耳。在一些实施例中,可以校准功率和持续时间到不足以引起严重损伤的程度,并且尤其不足以消融血管内病变组织的程度。在血管内消融动脉粥样硬化物质的机理已经得到充分描述,包括Slager et al.,在题为“由火花侵蚀的粥样硬化斑块的汽化”的文章中,J.of Amer.Cardiol.(1985年6月),pp.1382‐6;以及Stephen M.Fry,在“热和破坏性血管成形术:医生指南”;Strategic BusinessDevelopment,Inc.,(1990),通过引用其全部内容并入本文中。
在一些实施例中,应用到一根或者两根病人肾脏动脉的能量治疗,与可能应用在其他身体通道的能量治疗相比,可以在更高的水平上应用而不具有有害影响。例如,如果加热超过某个热反应限值,身体的外周和冠状动脉可能易受有害的长期阻塞反应的影响。但是已经发现,肾脏动脉加热超过这种热反应限值而不具有有害影响。
在一些实施例中,可以给本文所描述的电极通电进行评估,接着选择治疗目标组织,以通过所治疗组织的重建来实现所需要的治疗结果。例如,利用阻抗测量,可以使用组织特征来辨别组织的治疗区域。使用身体通道内周向间隔电极的阻抗测量,可以用来分析组织。相邻电极对之间的阻抗测量可以是不同的,例如当电路穿过病变组织和当其穿过腔壁的健康组织时。因此,在病变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目标组织,同时其他相邻电极对之间的测量可指示健康组织。其他特性,例如血管内超声,光学相干断层扫描或者类似的,或者与阻抗测量结合,或者替代其,可以用来识别要进行治疗的区域。在一些例子中,需要获得要被治疗组织的基线测量值,以帮助区分相邻组织,因为人和人之间组织特征和/或特征轮廓可以是不同的。另外,组织特征和/或特征轮廓曲线可以规范化方便识别不同组织之间的相关斜率、偏移以及类似的。阻抗测量可以以一个以上的频率获得,理想的是两个不同的频率(低和高)。低频测量可以在大约1‐10kHz或者大约4‐5kHz的范围内进行,而高频测量可以在大约300kHz‐1MHz,或者在大约750kHz‐1MHz之间的范围内进行。较低的频率测量主要表示阻抗的电阻分量,并且可以与组织温度密切相关,然而较高的频率测量可以表示阻抗的电容分量,并且可以与细胞成分的破坏和改变密切相关。
由于作为阻抗的电容和电阻变化结果的电流和电压之间的峰值变化,也可能发生阻抗的电阻和电容分量之间的相角偏移。也可以监视相角偏移,作为估计组织接触和RF去神经支配过程中毁损灶形成的手段。
在一些实施例中,身体内腔或通道的重建,可以通过结合温和或标准扩张的温和加热来实施。例如,具有电极布置其上的血管成形术球囊导管结构,可以在扩张前、扩张中和/或扩张后将电势施加到血管壁,选择结合标准的、未加热的血管成形术扩张压力,或者明显低于该压力的扩张压力。由于10‐16个大气压的球囊膨胀压力,例如,可以适合特定毁损灶的标准血管成形术扩张,本文所描述的结合适当电势(通过球囊上的柔性电路电极、直接布置在球囊结构上的电极等)的修正扩张治疗,可以使用大约10‐16个大气压,或者可以在6个大气压的压力或者更小的压力下起效,可以低至约1到2个大气压。这种适度的扩张压力可以(或者不可以)与组织特性方面、调谐能量方面、偏心治疗方面,以及用于治疗体腔治疗、循环系统和外周脉管疾病的本文所描述的其他治疗方面中的一个以上结合。
在许多实施例中,在身体通道扩张前、中和/或后所加入的温和加热能量,可以在降低并发症的同时增加扩张的效率。在一些实施例中,这种使用球囊控制的加热展示出了反冲的减少,具有至少一些类似支架扩张的优点,而不具有植入的缺点。通过限制外膜层低于有害响应阈值的加热,可以增强加热的益处(并且/或者抑制并发症)。在许多情况下,这种内膜和/或中膜的加热,可以使用少于大约10秒,经常少于3(甚至2)秒的加热时间进行。在其他的情况下,非常低的功率可以用于更加长的持续时间。通过将电路的驱动电位与靶组织的相角进行匹配,能量到靶组织的有效耦合可以增强所需要的热效率,有效地最大化电功率曲线下方的面积。相角的匹配不是绝对的,尽管与表征的目标组织的完全的相匹配是具有优势的,但是替代系统可以预设定合适的电位来基本上匹配典型的靶组织;尽管实际相角可能未被精确匹配,但是靶组织内的加热定位可以比使用标准功率的形式显著更好。
在一些实施例中,单极(唯一级)RF能量应用可以在可扩张件上的任意一个电极和定位在皮肤外侧或者装置本身上的公共接地或返回电极之间传送。在需要深度毁损灶的区域,需要单极RF。例如,在单极应用中,每个电极对以正极性供电,而不是每个电极对具有一个正极和一个负极。在一些实施例中,鉴于通过变化电极对中电极的极性能够选择实现各种深度/尺寸的毁损灶,可以对单极和双极RF能量应用进行结合。
可以控制RF能量的应用以便限制靶和/或侧支组织的温度,限制靶组织的加热使得目标组织和侧支组织都不遭受不可逆的热损伤。在一些实施例中,表面温度的范围可以从大约50℃到大约90℃。对于温和加热,表面温度的范围可以从大约50℃到大约70℃,同时对于大多数的积极加热,表面温度的范围可以从大约70℃到大约90℃。限制加热以便将侧支组织的加热抑制在小于大约50℃到大约70℃范围内的表面温度,使得体组织的温度仍然大多数低于大约50℃到大约55℃,可以抑制可能另外导致狭窄、热损伤等免疫反应。
在一些实施例中,目标温度可以在治疗过程中变化,并且可以,例如,是治疗时间的函数。一条可能的目标温度曲线可以包括具有30秒持续时间的治疗,以及从标称体温到大约68℃最大目标温度的12秒倾斜上升。在12秒倾斜上升的阶段,目标温度曲线可以由一个二次方程定义,在该方程中,目标温度(T)是时间(t)的函数。可以设置方程的系数,使得从标称体温到大约68℃的斜面可以遵循抛射体在重力影响下行进到达其弧线最高点的轨迹路径。换句话说,可以设定斜面,使得随着到达12秒和68℃,在温度的斜边上有恒定的减速(d2T/dt2),并且在温度的增加上有限性减少的斜率(dT/dt)。随着接近68℃斜率逐渐减小的这种曲线可有助于使治疗其余部分超过和/或未达到设定的靶目标最小化。在一些实施例中,目标温度曲线可能同样适用于双极或单极治疗,尽管,在至少一些单极的实施例中,治疗时间可能增加。其他使用不同持续时间(例如,3秒、5秒、8秒、12秒、17秒等)的目标温度曲线和设定目标温度(55℃、60℃、65℃、70℃、75℃等),可以以各种组合的方式根据需要进行使用。对于每一条所考虑的目标温度曲线,可以采用表现为或者近似为二次方程的温度斜面,但是可以使用有效加热组织,优化治疗时间以及避免对靶组织造成热损伤的任何函数或者其他曲线。然而,在其他的实施例中,没有必要使用实现所有目标的温度曲线。例如并且非出于限制,在至少一些实施例中,治疗时间的优化可能不是必须的。
如上文所详细描述的,可以使用图1控制单元110的处理功能和/或控制软件来执行控制方法,也可以以其他方式。在至少一些例子中,所述控制方法可以在装置的各种治疗位置提供温度或其它治疗参数的细调,同时使用相对简单且耐用的能量发生器以单个输出设定(例如电压)同时给几个电极或者其他输送位置通电,这可以最小化系统的成本、尺寸和复杂性。该控制方法可以最大限度地减少目标温度或者其他治疗参数的偏差,因此尽量减少任何治疗时间片中对能量发生器需求的变化(例如,电压需求)。
在一些实施例中,需要基于如上文所描述的目标温度曲线来调节RF或者其他能量的应用,以提供温和、受控的加热,这种加热避免了高瞬时功率的应用,以及微观水平上的相关组织灼烧或者其它损伤,这可能不希望地导致了加热块,或者另外引起装置/组织接口处的热传导的热传递的净减少。换句话说,通过避免温度上的较高波动和所产生的能量瞬时较大应用来重建接近目标温度的温度,紧接接口位置的组织完整性可以被保留。组织脱水可能导致热导率的净损失,导致针对超出电极/组织接口的目标组织的能量温和、治疗传送的有效输出的减少。
本领域的技术人员可以认识到,尽管出于说明的目的,特定的控制方法是结合上文已经描述的特定电外科装置进行介绍的,这些控制方法以及类似的方法可以有益处地用到其他的电外科学置上。
通常,控制方法可以力求将各个治疗部位维持在预定的目标温度,例如以上文所讨论的一条目标温度曲线。在一些实施例中,控制方法主要可以通过调节RF生成器的输出电压并且确定哪个电极将在指定的时间片通电(例如,周期地转换特定电极的开和关)来将治疗部位维持在预定的目标温度。
生成器的输出设定和电极的转换可以由反馈回路来确定,该反馈回路考虑了所测量的温度以及之前所需要的输出设定。在特定的治疗周期中(例如25毫秒的治疗时间片),每个电极可以被识别为三种状态之一:关闭、通电或者测量。在一些实施例中,如果电极符合一定的标准,它们可以仅仅处在通电和/或测量状态(通电的电极也可能在测量),默认的电极状态为关闭。已经被识别为通电电极或者测量电极的电极可以具有施加电压,或者检测部分周期或整个周期的温度信号。
在一些实施例中,可以设计控制方法以保持尽可能多的候选电极,这些电极尽可能的接近目标温度,同时最小化温度上的变化,因此最小化从治疗周期到治疗周期电压需求上的变化。
每个电极可初始设置为关闭。在下一步骤中,所述电极中的一个可以被指定为该治疗周期的主电极。正如下文所进一步详细讨论的,在治疗过程中,被指定的主电极可以从治疗周期到治疗周期而变化(例如周期经过所有可用的电极)。确定哪个电极可以被指定为主要电极,可以通过访问查找表或者使用任何其他识别主要电极的合适功能进行,并且主要电极的选择根据治疗周期而变化。
另外,在上文所讨论的下一步骤中,也可以将另外的电极指定为用来在治疗周期中通电和/或测量的候选电极。被指定的另外的电极可以成为候选是由于相对于用于治疗周期的被指定的主要电极存在某种关系或者缺少某种关系。
例如,在一些双极电极的实施例中,消融装置上的一些电极可能是以这样一种方式进行布置,那就是如果主电极和那些另外的电极在治疗周期中同时通电,在主电极和那些其他电极之间可能有潜在的电流泄漏,这种泄漏可以不希望地对相关温度传感器进行的温度测量产生干扰,在每个电极产生不精确的电量传送,或者其他不希望的结果。例如,在图3所示出的实施例中,如果电极片150c被指定为主电极,具有与电极片150c的正极紧邻或者接近的负极的电极片150d和170d,可不考虑作为用在那个特定治疗周期的测量和/或通电的候选,因为它们在接近被指定的主电极的地方会引起泄漏。另外,在该实施例中,具有与电极片150c的负极紧邻或者接近的正极的电极片150b,可不考虑作为候选,因为它在接近被指定的主电极的地方也会引起泄漏。此外,在该特定的实施例中,电极片170b也可以考虑作为非候选,因为其可能在和引起泄漏的近侧电极片150b相同的柔性结构上。最后,在特定的实施例中,电极片150a和170a可以考虑作为候选,因为它们相邻非候选。
作为另一个非限制性的例子,在一些单极电极的实施例中,候选电极可以是单极电极,所述单极电极具有测量或者估算电能性能,所述性能类似于和主电极相关联的电路的一个以上的测量或者估算性能。换句话说,在一些单极系统中,仅仅需要同时通电界定了电路的单极电极,这些电路基本上类似于由主单极电极界定的电路(例如,由单极电极、公共电极和穿过病人组织的通道所界定的电路)。在一些例子中,这可能有利于通电期间电流的均匀性。换句话说,预先界定的表格或者其他清单或者联合,可以基于当前主电极确定哪个电极为候选电极。
在至少一些实施例中,可以打开与非候选相关的开关,以将非候选与系统电路的剩余部分隔离。这种开关,在至少一些实施例中,也可以用于或者替代地用于用别的方法最大化可用于通电的可用电极对的数目,如果电极对之间的公共接地不受断电的影响。
在其他的实施例中,可以配置消融装置来避免泄漏的可能性,或者用别的方法来考虑泄漏,因此在治疗的周期中,装置的所有电极可以作为通电和/或测量的候选。
在一些实施例中,电极或者作为主电极,或者作为候选电极,或者作为非候选电极的分配可以由序列矩阵或者阵列查找表来确定,所述序列矩阵或者查找表识别每个电极的状态以及主电极指定顺序。在一个非限制性的实施例中,主电极的指定周向地经过近侧电极,接着周向地经过远侧电极循环(例如图3中所示,顺序可以是170a、b、c、d、150a、b、c、d)。然而,可以使用任何模式和其他方法,包括优化与序列上下一个之间的距离,优化与序列上下一个的接近程度,或者分布的均匀性。
在一些实施例中,对于特定的治疗周期并且/或者剩余的治疗,另外的情况可能导致特定的电极被设定为关闭。例如,如下文所讨论的,在治疗的过程中,可以允许高达4℃温度超调(例如,即使这种超调导致电极未通电,电极也未必被设定为关闭并且仍然可以用于测量);然而在至少一些实施例,如果八个连续治疗周期测量特定电极的温度超调,对于剩下的治疗,电极可以设定为关闭,治疗继续进行而不改变如下文所讨论的控制回路过程。
下一步,可以确定主电极和其他候选电极中每一个的目标电压。在一些实施例中,特定电极的目标电压可以基于与电极治疗位置关联的温度错误以及电极的所计算的上次目标电压(尽管未必施加)来确定。温度误差可以通过测量治疗部位的当前温度(例如,使用和紧邻治疗部位的电极相关的温度传感器),和确定治疗中瞬时的测量温度和目标温度之间的差来计算。
本领域的技术人员能够认识到,尽管一些实施例被描述成使用电压作为控制变量,但是功率能够用来替代电压作为控制变量,基于例如功率和电压之间已知的关系(例如功率等于电压乘以电流,或电流的平方乘以阻抗,或者电压的平方除以阻抗)。
一个实施例可以包括确定电极目标电压的子程序。例如,一个步骤可以包括计算与目标(Te)的温度误差,所述目标(Te)通过实际温度(T)(例如通过与该电极相关联的热敏电阻来测量)减去时间(Tt)时的目标温度获得。随后,确定在计算步骤计算的温度误差是否大于4℃(即,如果目标温度为68℃,则确定由热敏电阻测量的温度是否高于72℃)。如果温度误差大于4℃,子程序针对该治疗周期分配该电极的目标电压为零。如果温度误差不大于4℃,则子程序前进至下一个步骤,并判断温度误差是否大于2℃。如果温度误差大于2℃,则子程序向该电极分配该电极上次分配的目标电压的75%(或另一个百分比)作为目标电压。如果温度误差不大于2℃,则子程序可基于方程来为该电极分配目标电压:
其中:
V是目标电压;
Te是与目标温度的温度误差;
VL是上次分配的电极电压;
KL,KP和KI是常数;和
n是从0到t秒的时间值。
在一些实施方式中,使用的方程可以是:
其中:
V是目标电压;
Te是与目标温度的温度误差;
VL是上次分配的电极电压;
KP是来自比例控制的常数;和
KI是来自积分控制的常数。
在一些实施方式中,仅使用上次分配的电极电压来确定目标电压是有利的,而不是使用电压的平均值或者较早治疗周期的电压,因为在一些情况下,在聚焦于精密控制目标温度的实施例中,使用较早的电压可能是计算误差的根源。
一旦确定了主电极和其它候选电极的目标电压,确定主电极的目标电压是否大于零。如果不是,在那个治疗周期把RF生成器的输出电压设定成为确定的其他侯选电极的最低目标电压。如果确定的主电极的目标电压大于零,在那个治疗周期把射频发生器的输出电压设定成为主电极的目标电压。
下一步,目标电压大于零的主电极和其它候选电极被识别为待通电的电极。在替代实施例中,如果那些电极确定的目标电压比设定电压大6V,则仅通电除了主电极之外的候选电极。在一些实施例中,如果这些电极确定的目标电压比设定电压大1V、5V或10V,则仅通电除了主电极之外的候选电极。
最后,确定待通电的电极目前温度是否高于68℃。切断那些温度高于68℃的电极或以其它方式防止这些电极在这个治疗周期中被通电,以设定电压通电那些另外满足以上标准的电极。随后,另一个治疗周期开始,可重复控制方法直到治疗完成。在一些实施例中,各治疗周期与上一个和下一个治疗周期不重叠(例如,控制方法的步骤在下一个周期的步骤开始之前完全执行),尽管在其它实施方式中,周期可至少在一定程度上重叠。
现在回到图7,如上文所讨论的,肾神经消融装置120可以包括可以布置在细长管形件或导管轴122远端中、上、周围或附近的可扩张件130。在一些实施例中,可扩张件130可以包括电极组件300。在一些实施例中,电极组件300可以包括接地电极310、有源电极312和传感器元件314。在一些实施例中,接地电极310可以相邻有源电极312布置。在一些实施例中,传感器元件314可以相邻接地电极310和/或有源电极312布置。在一些实施例中,接地电极310、有源电极312和/或传感器元件314可以沿可扩张件130的长度延伸。在一些实施例中,接地电极310、有源电极312和/或传感器元件314可以沿基本上可扩张件130的全部长度延伸。
在一些实施例中,接地电极310、有源电极312和/或传感器元件314可以成形为离散的金属箔片、导线或者其他彼此间隔开的导电材料,并且以盘旋或者螺旋的图案或者沿可扩张件130外表面以盘旋或者螺旋的取向布置。接地电极310、有源电极312和/或传感器元件314通常可以彼此平行地定向。可以布置盘旋或者螺旋的结构或者取向,使得与可扩张件130的纵轴线L‐L正交或者垂直布置的平面可以在单个位置横穿电极组件300、接地电极310、有源电极312和/或传感器元件314,使得沿可扩张件130的长度,电极组件300、接地电极310、有源电极312和/或传感器元件314在任何位置都不会纵向自身重叠。然而也可以考虑其他的布置。沿可扩张件130长度的螺旋取向在可扩张件130所布置的腔或血管内形成至少一个完整的(360度)圆周环。为了破坏位于环绕身体通道壁的组织内的神经,电极在环绕身体通道的组织内的位置加热,而不损害该身体通道壁。需要螺旋取向来帮助避免狭窄增加的风险,当电极布置在与身体通道的纵轴正交的单个平面内时(例如,圆形电极或者电极组),狭窄可能出现。
在一些实施例中,肾神经消融装置120可以包括单个接地电极310和单个有源电极312。因此,可以结合接地电极310和有源电极312来形成双极电极对。当肾神经消融装置120通电(例如以上文所描述的方式),RF能量或者其他合适的能量可以自有源电极312传递到接地电极310,因此造成相应的毁损灶或者沿其内布置有可扩张件130的身体通道的毁损灶。传感器元件314可以布置在接地电极310和有源电极312之间。传感器元件314可以包括至少一个定位在可扩张件130外表面上的温度传感器326,诸如热敏电阻或者热电偶。这至少一个的温度传感器326可以定位在接地电极310和有源电极312之间,并且可以如上文所讨论的,配置用来监视目标组织、有源和接地电极的温度,或者两者的温度。在一些实施例中,这至少一个温度传感器326可以包括多个配置用来在沿可扩张件130长度的多个位置,监视目标组织、有源电极、接地电极或者它们任意组合的温度。
在一些实施例中,接地电极310、有源电极312和/或传感器元件314可以连接到可扩张件130,并且可操作地连接到控制单元110和/或RF生成器。在一些实施例中,接地电极310、有源电极312和/或传感器元件314可以放入可扩张件130外表面上的槽内,使得接地电极310、有源电极312和/或传感器元件314不向外超过可扩张件130的外表面突出。如图7中所示,在一些实施例中,接地电极310和有源电极312形成单个电极对,这些电极每个具有以螺旋的方式沿可扩张件130的长度不间断延伸的暴露的电极表面。因此,当该单个电极对通电时,可以在有源电极312和接地电极310之间形成单个、连续、螺旋的毁损灶。
在一些实施例中,肾神经消融装置120可以包括绝缘材料350的一个以上的离散区域,这些区域布置在接地电极310和/或有源电极312的一个以上的部分上,以产生暴露电极表面的多个离散长度。有源电极312的暴露电极表面的多个离散长度可以形成多个有源电极。在一些实施例中,多个有源电极可以由单根导电条或者导线形成。接地电极310的暴露电极表面的多个离散长度可以形成多个接地电极。在一些实施例中,多个接地电极可以由单根导电条或者导线形成。在一些实施例中,多个接地电极可以相邻多个有源电极布置。如图8中所示,为了在不连续的位置输送消融,多个有源电极可以对应多个接地电极,例如1:1的有源电极与接地电极,1:2的有源电极与接地电极,1:3的有源电极与接地电极,2:1的有源电极与接地电极,3:1的有源电极与接地电极,或者其他合适的比例。在一些实施例中,如上文所讨论的,形成多个有源电极和/或多个接地电极的暴露电极表面的多个离散长度中的每一个,可以包括布置在它们之间的温度传感器。
在一些实施例中,绝缘材料350的一个以上的离散区域,可以添加到可扩张件130,并且/或者在接地电极310和有源电极312连接到可扩张件130后,形成在接地电极310和有源电极312上。在一些实施例中,绝缘材料350的一个以上的离散区域可以通过在可扩张件130的壁内一体成型接地电极310和有源电极312形成,或者通过将接地电极310和有源电极312布置在位于可扩张件130壁内的离散的腔内形成,所述可扩张件130在单对电极的暴露电极表面(例如,多个有源电极和/或多个接地电极)的离散长度所在的一个以上的位置形成有开口和/或孔。
在一些实施例中,图4的电极组件200可以以螺旋的方式定向或布置,类似于上文所讨论的电极组件300。在一些实施例中,为了在不连续的位置传送消融,电极组件200可以形成为暴露电极表面的多个离散长度。
在一些实施例中,电极组件300可以缺少接地电极310,或者接地电极310可以不连接到控制单元110,使得有源电极312可以形成为单极电极。在使用单极电极的实施例中,可以使用分离的公共接地电极。公共接地电极能够是有源电极312的返回电通路。因此,可以给有源电极312传送能量,并且公共接地电极可以是返回电通路。
现在回到图9,如上文所讨论的,肾神经消融装置120可以包括可以布置在细长管形件或导管轴122远端中,或者该远端上、周围或附近的可扩张件130。在一些实施例中,可扩张件130可以包括形成在部分柔性聚合物片460上、中或者形成为部分柔性聚合物片460的电极组件400。在一些实施例中,电极组件400可以包括接地电极410、有源电极412和传感器元件414。在一些实施例中,接地电极410可以相邻有源电极412布置。在一些实施例中,传感器元件414可以相邻接地电极410和/或有源电极412布置。在一些实施例中,接地电极410、有源电极412和/或传感器元件414可以沿可扩张件130的长度延伸。在一些实施例中,接地电极410、有源电极412和/或传感器元件414可以沿基本上可扩张件130的全部长度延伸。在一些实施例中,柔性聚合物片460可以连接、粘帖、结合或者用另外的方式连接到可扩张件130的外表面。在一些实施例中,接地电极410和有源电极412可以布置在柔性聚合物片460的背离可扩张件130的外表面上,使得接地电极410和有源电极412不可以与可扩张件130直接接触。在一些实施例中,传感器元件414可以布置在柔性聚合物片460的面朝可扩张件130的内表面上,使得传感器元件414可以与可扩张件130直接接触。在一些实施例中,接地电极410和有源电极412可以布置在柔性聚合物片460的面朝可扩张件130的内表面上,使得接地电极410和有源电极412可以与可扩张件130直接接触。在一些实施例中,传感器元件414可以布置在柔性聚合物片460的背离可扩张件130的外表面上,使得传感器元件414不与可扩张件130直接接触。也可以考虑其他形态。
在一些实施例中,接地电极410、有源电极412和传感器元件414可以形成为离散的金属箔片、导线或者其他彼此间隔开的导电材料,并且以盘旋或者螺旋的图案或者沿可扩张件130外表面以盘旋或者螺旋的取向布置。接地电极410、有源电极412和传感器元件414通常可以彼此平行地定向。可以布置盘旋或者螺旋的图案或者取向,使得与可扩张件130的纵轴线L‐L正交或者垂直布置的平面可以在单个位置横穿电极组件400、接地电极410、有源电极412和/或传感器元件414,使得沿可扩张件130的长度,电极组件400、接地电极410、有源电极412和/或传感器元件414在任何地方都不纵向重叠自己。然而也可以考虑其他的布置。沿可扩张件130长度的螺旋取向在可扩张件130所布置的腔或血管内形成至少一个完整的(360度)圆周环。为了破坏位于环绕身体通道壁的组织内的神经,电极在环绕身体通道的组织内的位置加热,而不损害该身体通道壁。需要螺旋取向来帮助避免狭窄增加的风险,当电极布置在与身体通道的纵轴正交的单个平面内时(例如,圆形电极或者电极组),狭窄可能出现。
在一些实施例中,肾神经消融装置120可以包括单个接地电极410和单个有源电极412。因此,可以结合接地电极410和有源电极412来形成双极电极对。当肾神经消融装置120通电(例如以上文所描述的方式),RF能量或者其他合适的能量可以自有源电极412传递到接地电极410,因此造成沿身体通道的相应的一个毁损灶或者多个毁损灶,在该身体通道内布置有可扩张件130。传感器元件414可以布置在接地电极410和有源电极412之间。传感器元件414可以包括至少一个定位在可扩张件130外表面上的温度传感器426,例如热敏电阻或者热电偶。在一些实施例中,这至少一个的温度传感器426可以布置在柔性聚合物片460的内表面上,使得这至少一个温度传感器426可以与可扩张件130的外表面直接接触。在一些实施例中,这至少一个温度传感器426可以有效地夹在可扩张件130和柔性聚合物片460之间,使得没有一个温度传感器426可以暴露于身体通道。这至少一个温度传感器426可以定位在接地电极410和有源电极412之间,并且如上文所讨论的,可以被配置用来监视目标组织、有源和接地电极,或者两者的温度。在一些实施例中,这至少一个的温度传感器426可以包括多个配置用来在沿可扩张件130长度的多个位置,监视目标组织、有源电极、接地电极或者它们任意组合的温度。
在一些实施例中,接地电极410、有源电极412和/或传感器元件414可以连接到可扩张件130,并且可操作地连接到控制单元110和/或RF生成器。在一些实施例中,接地电极410、有源电极412和/或传感器元件414可以放入可扩张件130外表面上的槽内,使得接地电极410、有源电极412和/或传感器元件414不向外突出超过可扩张件130的外表面。如图9中所示,在一些实施例中,接地电极410和有源电极412形成单个电极对,这些电极每个具有以螺旋的方式沿可扩张件130的长度不间断延伸的暴露的电极表面。因此,当该单个电极对通电时,可以在有源电极412和接地电极410之间形成单个、连续、螺旋的毁损灶。
在一些实施例中,肾神经消融装置120可以包括绝缘材料450的一个以上的离散区域,这些区域布置在接地电极410和/或有源电极412的一个以上的部分上,以产生暴露电极表面的多个离散长度。有源电极412的暴露电极表面的多个离散长度可以形成多个有源电极。在一些实施例中,多个有源电极可以由单根导电条或者导线形成。接地电极410的暴露电极表面的多个离散长度可以形成多个接地电极。在一些实施例中,多个接地电极可以由单根导电条或者导线形成。在一些实施例中,多个接地电极可以相邻多个有源电极布置。如图10中所示,为了在不连续的位置输送消融,多个有源电极可以对应多个接地电极,例如1:1的有源电极与接地电极,1:2的有源电极与接地电极,1:3的有源电极与接地电极,2:1的有源电极与接地电极,3:1的有源电极与接地电极,或者其他合适的比例。在一些实施例中,如上文所讨论的,形成多个有源电极和/或多个接地电极的暴露电极表面的多个离散长度中的每一个,可以包括布置在它们之间的温度传感器。
在一些实施例中,绝缘材料450的一个以上的离散区域,可以加到可扩张件130,并且/或者在接地电极410和有源电极412与柔性聚合物片460和/或可扩张件130一起形成,或者连接到柔性聚合物片460和/或可扩张件130后,形成在接地电极410和有源电极412上。在一些实施例中,绝缘材料450的一个以上的离散区域可以通过在柔性聚合物片460内和/或可扩张件130的壁内一体成型接地电极410和有源电极412而形成,或者通过将接地电极410和有源电极412布置在位于可扩张件130壁内的离散的腔内形成,所述可扩张件130在单对电极的暴露电极表面(例如,多个有源电极和/或多个接地电极)的离散长度所在的一个以上的位置形成有开口和/或孔。
在一些实施例中,电极组件400可以缺少接地电极410,或者接地电极410可以不连接到控制单元110,使得有源电极412可以形成为单极电极。在使用单极电极的实施例中,可以使用分离的公共接地电极。公共接地电极能够是有源电极412的返回电通路。因此,可以给有源电极412传送能量,并且公共接地电极可以是返回电通路。
正如名字所提示的,可以将公共接地电极用作多于一个的有源电极的公共接地。例如,尽管图7和9中仅仅示出了一个有源电极312、412,消融装置120可以包括多个有源电极,例如图8和图10中所示,并且公共接地电极可以是至少一些或者在至少一些实施例中是全部有源电极的公共接地。可以考虑包括任何合适数目有源电极的各种实施例,包括一个、两个、三个、四个、五个、六个、七个、八个、九个、十个或者更多个有源电极
因为可以将公共接地电极用作多个有源电极的返回电极,有源电极不需要具有与每个有源电极配对的双极返回电极(即,接地迹线)。这可以允许有源电极和/或与其相关的其他结构,以更小的尺寸或者空间占用进行构建。这可以如所希望地影响装置的整体结构。例如,更小的有源电极可以更加柔性,可以更加容易地折叠球囊(例如,当可扩张件130采用球囊的形式时),提供更加少的抓取点,或者用别的方法减少当朝近侧收回消融装置120时有源电极的边缘从可扩张件130的表面被提起的可能性,缩小了消融装置120的轮廓,或者类似的。这些仅仅是例子。
使用中,可以使消融装置120前进穿过血管到达相邻靶组织的位置(例如,肾动脉内)。在一些实施例中,靶组织可以是肾动脉周围的一根以上的肾神经。当被合适地定位,可扩张件130可以从塌缩输送形态扩张到扩张形态。这可以使得有源电极312、412抵靠血管壁放置。可以激活有源电极312、412。消融能量可以从有源电极312、412起,穿过靶组织(肾神经被消融、调制或者以其他方式受到影响的地方),穿过接地电极310、410返回的方式以双极形态进行传输,或者穿过公共接地电极返回的方式以单极形态进行传输。
公共接地电极的形式也可以是不同的。例如,公共接地电极可以采用沿可扩张件130布置的导电材料的网格或者矩阵的形式。也可以考虑其他的实施例。例如,公共接地电极可以采用涂层的形式,例如应用在可扩张件130的外表面的导电涂层。例如,该涂层可以是溅射涂覆在可扩张件130上的金涂层。在一些实施例中,涂层可以覆盖可扩张件130表面面积的大约50%或者更多,或者可扩张件130表面面积的大约60%或者更多,或者可扩张件130表面面积的大约70%或者更多,或者可扩张件130表面面积的大约80%或者更多,或者可扩张件130表面面积的大约90%或者更多。这些仅仅是例子。也可以考虑其他的涂层,并且任何合适的涂层都能够和本文所公开的任何装置一起使用。
能够用于消融装置120各种部件的材料(和/或本文所公开的其他装置),可以包括那些通常与医疗装置关联的材料。为了简化的目的,下面的讨论参照消融装置120。然而,这不打算限制本文所描述的装置和方法,因为讨论可以应用到本文所公开的其他类似的管形件和/或可扩张件,和/或管形件和/或可扩张件的部件。
消融装置120及其各种部件可由金属,金属合金,聚合物(下文公开了其一些示例),金属‐聚合物复合物,陶瓷,及其组合等,或者其他合适的材料制成。合适的聚合物的一些示例可包括聚四氟乙烯(PTFE),乙烯‐四氟乙烯(ETFE),氟化乙烯丙烯(FEP),聚氧甲烯(POM,例如,杜邦公司出售的),聚醚嵌段酯,聚氨酯(例如,聚氨酯85A),聚丙烯(PP),聚氯乙烯(PVC),聚醚酯(例如,DSM工程塑料公司出售的),醚基或酯基共聚物(例如,丁烯/聚(亚烃基醚)邻苯二甲酸酯和/或诸如杜邦公司出售的的聚酯弹性体),聚酰胺(例如,拜尔公司出售的或埃尔夫阿托公司出售的),弹性体聚酰胺,嵌段聚酰胺/醚,聚醚嵌段酰胺(PEBA,例如以为商标名出售的产品),乙烯‐乙酸乙烯酯共聚物(EVA),硅树脂,聚乙烯(PE),马勒克斯高密度聚乙烯,马勒克斯低密度聚乙烯,线性低密度聚乙烯(例如,),聚酯,聚对苯二甲酸丁二醇酯(PBT),聚对苯二甲酸乙二醇酯(PET),聚对苯二甲酸丙二醇酯(polytrimethyleneterephthalate),聚萘二甲酸乙二醇酯(PEN),聚醚醚酮(PEEK),聚酰亚胺(PI),聚醚酰亚胺(PEI),聚苯硫醚(PPS),聚苯醚(PPO),聚对苯二甲酰对苯二胺(例如,),聚砜,尼龙,尼龙‐12(诸如EMS American Grilon公司出售的),全氟(丙基乙烯基醚)(PFA),乙烯基乙烯醇,聚烯烃,聚苯乙烯,环氧树脂,聚偏二氯乙烯(PVdC),聚(苯乙烯‐b‐异丁烯‐b‐苯乙烯)(例如,SIBS及/或SIBS 50A),聚碳酸脂,离聚物,生物相容聚合物,其他合适材料,或者前述材料的混合物,组合物,共聚物,聚合物/金属组合物,等等。在一些实施方式中,护套可与液晶聚合物(LCP)混合。例如,混合物可包含高达大约6%的LCP。
合适的金属和金属合金的一些例子可以包括不锈钢,例如304V、304L和316LV不锈钢;软钢;镍‐钛合金,诸如线性弹性和/或超弹性镍钛诺;其他镍合金如镍‐铬‐钼合金(例如,UNS:N06625如UNS:N06022如UNS:N10276如其他合金,以及类似的),镍‐铜合金(例如,UNS:N04400如400,以及类似的),镍‐钴‐铬钼合金(如,UNS:R30035如等),镍‐钼合金(如,UNS:N10665如合金),其他镍‐铬合金,其他镍‐钼合金,其他镍‐钴合金,其他镍‐铁合金,其他镍‐铜合金,其他镍‐钨或钨合金等;钴铬合金;钴‐铬‐钼合金(如,UNS:R30003如等);铂富集不锈钢;钛;它们的组合;以及类似的;或者任何其他合适的材料。
正如本文所提及的,在商业可获得的镍‐钛或镍钛诺合金家族中,有指定为“线弹性”或“非超弹性”的类别,尽管该类别在化学上与现有的形状记忆和超弹性品种类似,但是其可以展示不同而有用的机械属性。线弹性和/或非超弹性镍钛诺区别于超弹性镍钛诺,不像超弹性镍钛诺,线弹性和/或非超弹性镍钛诺不在应力/应变曲线上显示实质的“超弹性平台(superelastic plateau)”或者“旗形区域(flag region)”。取而代之的,在线弹性和/或非超弹性镍钛诺中,当可恢复应变增加时,应力继续以基本上线性,或者有点线性但未必完全线性的关系继续增加,直到弹性变形开始,或者至少以比超弹性镍钛诺示出的超弹性平台和/或旗形区域的更加线性的关系。因此,为了公开的目的,线弹性和/或非超弹性镍钛诺也可以表述为“基本上”线弹性和/或非超弹性镍钛诺。
在一些情况中,线弹性和/或非超弹性镍钛诺与超弹性镍钛诺也可以区别于,线弹性和/或非超弹性镍钛诺可以承受至多大约2‐5%的应变,而基本上仍然具有弹性(例如,在塑性变形前),然而超弹性镍钛诺在塑性变形前可以承受至多大约8%的应变。这两种材料都能区别于其他线弹性材料,例如不锈钢(也能够基于其成分进行区别),不锈钢在塑性变形前仅可以承受大约0.2%到0.44%的应变。
在一些实施例中,线弹性和/或非超弹性镍钛合金是不显示任何马氏体相/奥氏体相变化的合金,所述变化可以在大的温度范围内,通过差示扫描量热法(DSC)和动态金属热分析(DMTA)进行分析检测。例如,在一些实施例中,在线弹性和/或非超弹性镍钛合金中,在大约‐60摄氏度(℃)到大约120℃的范围内,没有可通过DSC和DMTA分析可以检测到的马氏体相/奥氏体相变。因此,这些材料的机械弯曲属性,在这个非常宽的温度范围内,通常对温度的效应具有惰性。在一些实施例中,线弹性和/或非超弹性镍钛合金环境温度或室内温度的机械弯曲属性与身体温度的机械属性基本上相同,例如,其中它们不显示超弹性平台和/或旗形区域。换句话说,在一个非常宽的温度范围内,线弹性和/或非超弹性镍钛合金维持其线弹性和/或非超弹性特征和/或属性。
在一些实施例中,线弹性和/或非超弹性镍钛合金可以大约50%到大约60%的重量百分比为镍,而剩下的基本上为钛。在一些实施例中,成分中大约54%到大约57%的重量百分比为镍。合适的镍钛合金的一个例子为FHP‐NT合金,可从日本神奈川的FurukawaTechno Material Co.购得。U.S.专利号5,238,004和6,508,803中公开了镍钛合金的一些例子,通过引用将它们并入到本文中。其他合适的材料可以包括ULTANIUMTM(可从Neo‐Metrics获得)和GUM METALTM(可从Toyota获得)。在一些其他的实施例中,超弹性合金,例如超弹性镍钛诺能够用来实现需要的属性。
在至少一些实施例中,消融装置120的部分也可以掺杂不透射线材料,或者由其制成或者用别的方法包含不透射线材料。可以将不透射线材料理解成,能够在医疗手术过程中在荧光屏上或者另一种成像技术产生相对亮的图像的材料。该相对亮的图像协助消融装置120的使用者确定其位置。不透射线材料的一些例子能够包括,但不限于金、铂、钯、钽、钨合金、装载有不透射线填充材料的聚合物材料等。另外,其他不透射线标记带和/或圈也可以并入到消融装置120的设计中,以实现相同的结果。
在一些实施例中,消融装置120被赋予了一定程度的磁共振成像(MRI)兼容性。例如,部分的装置,可以由基本上不使图像失真并且不产生实质伪影(例如,图像中的间隙)的材料制成。例如,某些铁磁材料可能不适合,因为它们在MRI图像中可能产生伪影。在一些或者其他的实施例中,部分的消融装置120也可以由MRI机器能够成像的材料制成。一些展示了这些特征的材料包括,例如,钨、钴‐铬‐钼合金(例如,UNS:R30003如等),镍‐钴‐铬‐钼合金(例如,UNS:R30035如 等),镍钛诺,和类似物,以及其它。
通过引用,下面文件的全部并入到本文中。
2013年1月25日申请的美国专利申请序号为13/750,879,现在公布为美国专利申请公布号US 20130165926A1,名称为“重构身体通道的组织或者重构与身体通道相邻的组织的方法和装置”。
另外的实施例
公开了一种肾神经消融装置。所述肾神经消融装置包括具有远端区域的细长管形件。连接到所述远端区域的可扩张件,所述可扩张件具有长度。连接到所述可扩张件的一个以上的有源电极。连接到所述可扩张件与所述一个以上有源电极相邻的一个以上的接地电极。布置在所述可扩张件的外表面上,与所述一个以上的有源电极和所述一个以上的接地电极相邻的一个以上温度传感器。所述一个以上的有源电极和所述一个以上的接地电极围绕所述可扩张件为螺旋定向。
另外地或者可替代上文任一实施例的,所述一个以上温度传感器布置在所述可扩张件的外表面上,在所述一个以上的有源电极和所述一个以上的接地电极之间。
另外地或者可替代上文任一实施例的,所述一个以上的接地电极平行于所述一个以上的有源电极定向。
另外地或者可替代上文任一实施例的,被布置成与所述可扩张件的纵轴线正交的平面,仅在沿所述可扩张件长度的单个位置横穿所述一个以上的接地电极。
另外地或者可替代上文任一实施例的,被布置成与所述可扩张件的纵轴线正交的平面,仅在沿所述可扩张件长度的单个位置横穿所述一个以上的有源电极。
另外地或者可替代上文任一实施例的,所述可扩张件包括一个以上的支杆。
另外地或者可替代上文任一实施例的,所述一个以上的有源电极沿所述支杆布置。
另外地或者可替代上文任一实施例的,所述可扩张件包括可扩张篮状物。
另外地或者可替代上文任一实施例的,所述可扩张件包括球囊。
另外地或者可替代上文任一实施例的,沿所述球囊的外表面形成槽并且其中所述一个以上有源电极中的至少一个布置在所述槽内。
另外地或者可替代上文任一实施例的,沿所述球囊的外表面形成槽并且其中所述一个以上接地电极中的至少一个布置在所述槽内。
另外地或者可替代上文任一实施例的,沿所述球囊的外表面形成槽,并且其中所述一个以上有源电极中的至少一个布置在所述槽内,并且其中所述一个以上接地电极中的至少一个布置在所述槽内。
另外地或者可替代上文任一实施例的,所述一个以上的有源电极包括沿所述可扩张件的所述长度延伸的单个有源电极。
另外地或者可替代上文任一实施例的,所述一个以上的有源电极包括沿所述可扩张件的所述全部长度延伸的单个有源电极。
另外地或者可替代上文任一实施例的,所述一个以上的接地电极包括沿所述可扩张件的所述长度延伸的单个接地电极。
另外地或者可替代上文任一实施例的,所述一个以上的接地电极包括沿所述可扩张件的所述全部长度延伸的单个接地电极。
公开了一种肾神经消融装置。所述肾神经消融装置包括具有远端区域的细长管形件。可扩张球囊连接到所述远端区域,所述可扩张球囊具有长度。多个螺旋定向的有源电极连接到所述球囊。多个螺旋定向的接地电极连接到所述球囊。多个温度传感器布置在所述球囊的外表面上,在所述多个螺旋定向的有源电极和所述多个螺旋定向的接地电极之间。
另外地或者可替代上文任一实施例的,所述多个接地电极平行于所述多个有源电极定向。
另外地或者可替代上文任一实施例的,被布置成与所述可扩张件的纵轴线正交的平面,仅在沿所述可扩张件长度的单个位置横穿所述多个接地电极。
另外地或者可替代上文任一实施例的,被布置成与所述可扩张件的纵轴线正交的平面,仅在沿所述可扩张件长度的单个位置横穿所述多个有源电极。
另外地或者可替代上文任一实施例的,沿所述球囊的外表面形成槽并且其中所述多个有源电极中的至少一个布置在所述槽内。
另外地或者可替代上文任一实施例的,沿所述球囊的外表面形成槽并且其中所述多个接地电极中的至少一个布置在所述槽内。
另外地或者可替代上文任一实施例的,沿所述球囊的外表面形成槽,并且其中所述多个有源电极中的至少一个布置在所述槽内,并且其中所述多个接地电极中的至少一个布置在所述槽内。
另外地或者可替代上文任一实施例的,沿所述球囊的外表面形成多个槽,并且其中所述多个有源电极中的至少一个布置在所述多个槽中的一个内,并且其中所述多个接地电极中的至少一个布置在所述多个槽中的另外一个内。
另外地或者可替代上文任一实施例的,在所述球囊的壁内形成腔,并且其中所述多个有源电极中的至少一个布置在所述腔内。
另外地或者可替代上文任一实施例的,在所述球囊的壁内形成腔,并且其中所述多个接地电极中的至少一个布置在所述腔内。
另外地或者可替代上文任一实施例的,所述球囊的壁内形成多个腔,并且其中所述多个有源电极中的至少一个布置在所述多个腔中的一个内,并且其中所述多个接地电极中的至少一个布置在所述多个腔中的另外一个内。
另外地或者可替代上文任一实施例的,所述多个有源电极由沿所述可扩张件的所述长度延伸的单根导线形成。
另外地或者可替代上文任一实施例的,所述多个有源电极由沿所述可扩张件的所述全部长度延伸的单根导线形成。
另外地或者可替代上文任一实施例的,所述多个接地电极由沿所述可扩张件的所述长度延伸的单根导线形成。
另外地或者可替代上文任一实施例的,所述多个接地电极由沿所述可扩张件的所述全部长度延伸的单根导线形成。
公开了一种肾神经消融装置。所述肾神经消融装置包括具有远端区域的细长管形件。可扩张球囊连接到所述远端区域,所述可扩球囊具有长度。连接到所述球囊的柔性聚合物片。所述柔性聚合物片包括螺旋定向的有源电极、螺旋定向的接地电极以及温度传感器,所述有源电极在所述柔性聚合物片的背离所述球囊的表面上,所述接地电极在所述柔性聚合物片的背离所述球囊的表面上相邻所述有源电极布置,所述温度传感器在所述螺旋定向的有源电极和所述螺旋定向的接地电极之间,所述温度传感器在所述柔性聚合物片面朝所述球囊的表面上。
另外地或者可替代上文任一实施例的,所述多个接地电极平行于所述多个有源电极定向。
另外地或者可替代上文任一实施例的,被布置成与所述可扩张件的纵轴线正交的平面,仅在沿所述可扩张件长度的单个位置横穿所述多个接地电极。
另外地或者可替代上文任一实施例的,被布置成与所述可扩张件的纵轴线正交的平面,仅在沿所述可扩张件长度的单个位置横穿所述多个有源电极。
另外地或者可替代上文任一实施例的,沿所述球囊的外表面形成槽并且其中所述柔性聚合物片布置在所述槽内。
另外地或者可替代上文任一实施例的,所述螺旋定向的有源电极由沿所述可扩张件的所述长度延伸的单根导线形成。
另外地或者可替代上文任一实施例的,所述螺旋定向的有源电极由沿所述可扩张件的所述全部长度延伸的单根导线形成。
另外地或者可替代上文任一实施例的,所述螺旋定向的接地电极由沿所述可扩张件的所述长度延伸的单根导线形成。
另外地或者可替代上文任一实施例的,所述螺旋定向的接地电极由沿所述可扩张件的所述全部长度延伸的单根导线形成。
公开了一种消融肾神经的方法。所述方法包括使肾神经消融装置前进穿过血管到达肾动脉内的位置。所述肾神经消融装置包括具有远端区域的细长管形件,连接到所述远端区域的可扩张件,所述可扩张件具有长度,连接到所述可扩张件的一个以上的有源电极,连接到所述可扩张件与所述一个以上有源电极相邻的一个以上的接地电极,以及布置在所述可扩张件的外表面上、与所述一个以上的有源电极和所述一个以上的接地电极相邻的一个以上温度传感器,所述一个以上的有源电极和所述一个以上的接地电极围绕所述可扩张件为螺旋定向。所述方法也包括使肾神经消融装置前进穿过血管到达肾动脉内的位置,扩张所述可扩张件,并且激活所述一个以上有源电极中的至少一个。
公开了一种肾神经消融装置。所述肾神经消融装置包括具有远端区域的细长管形件。可扩张球囊连接到所述远端区域,所述可扩张球囊具有长度。单个螺旋定向的有源电极连接到所述球囊。单个螺旋定向的接地电极连接到所述球囊。所述有源电极和所述接地电极中的至少一个包括设置在在其相应电极的至少一部分上的绝缘体,以便形成多个离散的电极,所述电极能够在靶部位形成多个离散的毁损灶。一个以上的温度传感器布置在所述球囊的外表面上,在所述螺旋定向的有源电极和所述螺旋定向的接地电极之间。
另外地或者可替代上文任一实施例的,单个有源电极包括设置在其部分长度上的绝缘体,以界定多个离散的有源电极区域。
另外地或者可替代上文任一实施例的,单个接地电极包括设置在其部分长度上的绝缘体,以界定多个离散的接地电极区域。
另外地或者可替代上文任一实施例的,沿所述球囊的外表面形成多个槽,并且其中所述一个以上的有源电极中的至少一个布置在所述多个槽内。
另外地或者可替代上文任一实施例的,沿所述球囊的外表面形成多个槽,并且其中所述一个以上的接地电极中的至少一个布置在所述多个槽内。
另外地或者可替代上文任一实施例的,沿所述球囊的外表面形成多个槽,并且其中所述一个以上有源电极中的至少一个布置在所述多个槽内,并且其中所述一个以上接地电极中的至少一个布置在所述多个槽内。
另外地或者可替代上文任一实施例的,沿所述球囊的外表面形成多个槽,并且其中所述多个有源电极中的至少一个布置在所述多个槽内。
另外地或者可替代上文任一实施例的,沿所述球囊的外表面形成多个槽,并且其中所述多个接地电极中的至少一个布置在所述多个槽内。
另外地或者可替代上文任一实施例的,沿所述球囊的外表面形成多个槽,并且其中所述多个有源电极中的至少一个布置在所述多个槽内,并且其中所述多个接地电极中的至少一个布置在所述多个槽内。
应该理解,本发明在许多方面仅仅是说明。在不超出本发明保护范围的前提下,可以在细节上进行变化,尤其在形状、尺寸和步骤安排方面。这可以包括,在一定程度应意识到,一个实施例所使用的所有特征可以用在其他实施例中。本发明的保护范围,当然用所附权利要求书所表达的语言进行界定。
Claims (15)
1.一种组织调制装置,包括:
具有远端区域的细长管形件;
连接到所述远端区域的可扩张球囊,所述可扩张球囊具有长度;以及连接到所述球囊的柔性聚合物片;
其中所述柔性聚合物片包括:
多个螺旋定向的有源电极,所述有源电极在所述柔性聚合物片背离所述球囊的表面上;
多个螺旋定向的接地电极,所述接地电极被设置在所述柔性聚合物片背向所述球囊的所述表面上相邻所述多个有源电极;以及
多个温度传感器组件,所述温度传感器组件被设置在所述柔性聚合物片面向所述球囊的表面上,每一个所述温度传感器组件包括温度传感器、传感器电源片、传感器接地片以及被设置在所述传感器电源片和所述传感器接地片上的绝缘层,其中所述传感器电源片和传感器接地片被至少部分地设置在所述绝缘层和所述温度传感器之间;
其中所述多个螺旋定向的有源电极和所述多个螺旋定向的接地电极形成多个双极电极对;以及
其中所述多个温度传感器中的一个被定位在形成所述多个双极电极对中的每一个的数个电极之间。
2.如权利要求1所述的装置,其中所述多个接地电极平行于所述多个有源电极定向。
3.如权利要求1所述的装置,其中被布置成与所述球囊的纵轴线正交的平面,仅在沿所述球囊长度的单个位置横穿所述多个接地电极。
4.如权利要求1所述的装置,其中被布置成与所述球囊的纵轴线正交的平面,仅在沿所述球囊长度的单个位置横穿所述多个有源电极。
5.如权利要求1‐4中任一所述的装置,其中沿所述球囊的外表面形成槽并且其中所述多个有源电极中的至少一个布置在所述槽内。
6.如权利要求1‐4中任一所述的装置,其中沿所述球囊的外表面形成槽并且其中所述多个接地电极中的至少一个布置在所述槽内。
7.如权利要求1‐4中任一所述的装置,其中沿所述球囊的外表面形成槽,并且其中所述多个有源电极中的至少一个布置在所述槽内,并且其中所述多个接地电极中的至少一个布置在所述槽内。
8.如权利要求1‐4中任一所述的装置,其中所述多个有源电极包括沿所述球囊的所述长度延伸的单个有源电极,所述长度被多个离散的绝缘材料区域中断。
9.如权利要求1‐4中任一所述的装置,其中所述多个接地电极包括沿所述球囊的所述长度延伸的单个接地电极,所述长度被多个离散的绝缘材料区域中断。
10.一种组织调制装置,包括:
具有远端区域的细长管形件;
连接到所述远端区域的可扩张件,所述可扩张件具有长度;
连接到所述可扩张件的多个有源电极;
连接到所述可扩张件与所述多个有源电极相邻的多个接地电极,所述多个有源电极和所述多个接地电极形成多个双极电极对;以及
多个温度传感器组件,所述温度传感器组件被设置在所述可扩张件的外表面上,每一个所述温度传感器组件包括温度传感器、传感器电源片和传感器接地片,以及被设置在所述传感器电源片和所述传感器接地片上的绝缘层,其中所述传感器电源片和传感器接地片被至少部分地设置在所述绝缘层和所述温度传感器之间;
其中所述多个温度传感器中的一个被定位在形成所述多个双极电极对中的每一个的数个电极之间;
其中所述多个有源电极和所述多个接地电极围绕所述可扩张件为螺旋定向。
11.如权利要求10所述的装置,其中所述可扩张件包括一个以上的支杆。
12.如权利要求11所述的装置,其中所述多个有源电极沿所述支杆设置。
13.如权利要求10所述的装置,其中所述可扩张件包括可扩张篮。
14.如权利要求10所述的装置,其中所述可扩张件包括球囊。
15.如权利要求14所述的装置,其中沿所述球囊的外表面形成槽并且其中所述多个有源电极中的至少一个被设置在所述槽内并且其中所述多个接地电极中的至少一个被设置在所述槽内。
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CN105682594A (zh) | 2016-06-15 |
US20150025525A1 (en) | 2015-01-22 |
EP3049007B1 (en) | 2019-06-12 |
WO2015010074A1 (en) | 2015-01-22 |
US9925001B2 (en) | 2018-03-27 |
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