CN114246667A - 具有绝缘消融电极的篮形导管 - Google Patents
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Abstract
本发明题为“具有绝缘消融电极的篮形导管”。本发明公开了一种导管,该导管包括用于插入患者的器官中的轴和可扩张远侧端部组件,该可扩张远侧端部组件耦接到轴和导管的顶点,并且包括多个长条。在该多个长条中的至少给定长条中,该给定长条的长度的至少六十%是非绝缘的并且被配置为与该器官的组织进行接触并将射频(RF)脉冲施加到该组织。
Description
相关申请的交叉引用
本申请涉及于同一日期提交的名称为“具有绝缘的消融电极和诊断电 极的篮形导管(Basket Catheter having insulated ablation electrodes and diagnosticelectrodes)”,代理人案卷号为BIO6389USNP1/1002-2268的美 国专利申请,该专利申请的公开内容以引用方式并入本文。
技术领域
本发明整体涉及医疗导管,并且具体地,涉及具有可扩张远侧端部的 消融导管。
背景技术
篮形导管可用于各种医疗应用诸如心脏病学中。具有多个长条的若干 类型的篮形导管被设计成使得能够感测和治疗心律失常。
例如,美国专利申请公布2014/0238175描述了用于向目标部位提供治 疗的方法、系统和设备。系统可包括引导组件、与引导组件的远侧端部耦 接的可扩张支撑设备,以及设置在可扩张支撑设备上的操作构件。可扩张 支撑设备可被配置为在塌缩配置和扩张配置之间转变。
美国专利6,292,695描述了一种通过使用电生理导管来控制心脏纤颤、 心动过速或心律失常的方法,该电生理导管具有容纳至少一个刺激电极的 末端区段,该刺激电极被稳定地放置在选定血管内位置处。电极连接到刺 激装置,并且刺激以足以使神经去极化并实现心脏控制的强度跨血管壁经 血管施加到支配心脏的交感神经或副交感神经。
美国专利6,421,556描述了用于诊断和治疗组织的系统和方法,该系统 和方法传输电能脉冲,该电能脉冲暂时使组织区域无法行动,从而暂时使 其无电响应。系统和方法感测由于所传输的脉冲而引起的电生理效应。系 统和方法至少部分地基于所感测的电生理效应来改变区域中或附近的组织 的电生理特性。电生理特性的改变可例如通过组织消融或通过施用药物来 实现。在一个具体实施中,射频能量用于暂时使组织无法行动并且通过公 共电极消融组织。
美国专利申请公布2015/0182282描述了用于单独地或与其他疗法组合 地生成等离子体和/或电场并将等离子体和/或电场施加到活组织以治疗不同 组织病症以及其他病症(诸如肿瘤、细菌感染等),同时限制所述组织内 的电流生成的各种系统和技术。
美国专利申请公布号2006/0100669示出并描述了使用篮形导管的针对 心房纤颤的系统。
发明内容
本文所述的本发明的实施方案提供了一种导管,该导管包括用于插入 患者的器官中的轴和可扩张远侧端部组件,该可扩张远侧端部组件耦接到 轴和导管的顶点,并且包括多个长条。在该多个长条中的至少给定长条 中,该给定长条的长度的至少六十(60)%是非绝缘的并且被配置为与该 器官的组织进行接触并将射频(RF)脉冲施加到该组织。
在一些实施方案中,该给定长条的长度的至多四十(40)%是绝缘的 并且定位在该非绝缘长度和该顶点之间。在其他实施方案中,该绝缘长度 涂覆有电绝缘层。在又一些其他实施方案中,至少该给定长条包括镍-钛合 金。
在一个实施方案中,该顶点具有与该轴的轴线正交的平坦表面。在另 一个实施方案中,平坦表面是绝缘的。在又一个实施方案中,该导管包括 凸块止挡件,该凸块止挡件耦接到该顶点并且被配置为限制该轴和该顶点 之间的最小距离。
根据本发明的实施方案,还提供了一种用于制造导管的方法,该方法 包括接收多个长条,使得在多个长条中的至少给定长条中,给定长条的长 度的至少六十(60)%是非绝缘的并且被配置为与患者的器官的组织接触 并将射频(RF)脉冲施加到该组织。所述多个长条被组装在一起以用于制 造可扩张远侧端部组件,并且所述可扩张远侧端部组件耦接到轴和所述导 管的顶点。
结合附图,通过以下对本发明的实施方案的详细描述,将更全面地理 解本发明,其中:
附图说明
图1为根据本发明的实施方案的基于导管的定位-跟踪和消融系统的示 意性图解;
图2和图3为根据本发明的实施方案的处于扩张位置的远侧端部组件 的示意性图解;
图4为示意性地示出了根据本发明的实施方案的用于制造具有绝缘消 融电极的篮形导管的方法的流程图;并且
图5为示意性地示出根据本发明的实施方案的用于使用图3的远侧端 部组件来消融组织的方法的流程图。
具体实施方式
概述
下文所述的本发明的实施方案提供了在消融系统的导管中使用的改善 的远侧端部组件的多种配置。在一些实施方案中,导管包括用于将远侧端 部组件插入患者心脏中的轴,以及耦接到轴和导管的顶点的可扩张远侧端 部组件(诸如篮形件)。
在一些实施方案中,远侧端部组件包括多个长条,其中长条中的至少 一个并且通常全部由固体镍钛诺制成并且具有至少两个区段。长条的第一 区段是非绝缘的、导电的,并且具有长条的长度的至少六十%。第一区段 被配置为与心脏的组织接触并且将射频(RF)脉冲施加到组织。
在一些实施方案中,长条的第二区段是绝缘的,包括长条的长度的至 多四十%,并且定位在非绝缘区段和导管的顶点之间。绝缘区段可包括长 条的镍钛诺,其涂覆有电绝缘层。
在一些实施方案中,顶点与长条电绝缘并且具有与轴的轴线(例如, 纵向轴线)正交的平坦表面。需注意,在上述配置中,第一区段是导电的 并且被配置为消融心脏组织,而第二区段和顶点是电绝缘的并且被配置为 在长条的非绝缘区段之间电绝缘。在此类实施方案中,在具有第一长条和 第二长条(其中的每一者具有第一区段和第二区段)的消融导管中,消融 系统的处理器被配置为控制射频(RF)脉冲发生器以将一个或多个RF脉 冲施加到第一长条,而不将任何RF脉冲施加到第二长条。
通常,在执行消融规程之前,进行心内信号的标测,例如以便限定用 于消融的目标组织。在一些实施方案中,可以使用长条的非绝缘区段以感 测心内信号。然而,包括长条的至少六十%的非绝缘区段可与心脏组织的 长区段接触,并且因此可能无法以足够高的横向分辨率(例如,约 1.0mm)感测心内信号以用于在消融之前标测组织。
在一些实施方案中,上述篮形远侧端部组件可包括一个或多个诊断电 极,在本文中也称为感测电极。在本示例中,感测电极耦接到电绝缘区段 和/或顶点。
在一些实施方案中,感测电极中的一者或多者被配置为例如在感测电 极和附接到皮肤或附接到患者的任何其他组织的参考电极之间感测单极信 号。
在其他实施方案中,感测电极中的两者或更多者设置在顶点和绝缘区 段上,并且被配置为感测双极信号。例如,第一感测电极和第二感测电极 可设置在第一长条的绝缘区段上,第三感测电极可设置在第二长条的绝缘 区段上,并且第四感测电极可设置在顶点上。在该配置中,消融系统的处 理器被配置为从四个感测电极中的任一对接收多个双极信号。例如,(i)第 一电极和第二电极之间的第一双极信号,(ii)第二电极和第三电极之间的第 二双极信号,以及(iii)第三感测电极和第四感测电极之间的第三双极信号。
所公开的技术特别有效地用于消融(i)长和窄的组织,例如在将一个或 多个RF脉冲施加到单个长条时,或(ii)长和宽的组织,例如在将RF脉冲施 加到多个长条时。因此,所公开的技术可减小消融规程的总周期时间。
此外,所公开的技术减小了将专用消融电极附接到可扩张导管的需 要,并且因此改善了长条的机械柔性并且减小了与制造消融导管的可扩张 远侧端部组件相关联的成本。
系统描述
图1为根据本发明的实施方案的基于导管的定位-跟踪和消融系统20 的示意性图解。在一些实施方案中,系统20包括导管22(在本示例中为可 扩张心脏导管)和控制台24。在本文所述的实施方案中,导管22可用于任 何合适的治疗目的和/或诊断目的,诸如心脏26中的组织的消融,并且用于 通过感测心内电信号来标测心律不齐。
在一些实施方案中,控制台24包括处理器42(通常为通用计算 机),该处理器具有合适的前端和接口电路,以用于从导管22接收信号并 且用于控制本文所述的系统20的其他部件。处理器42可以软件形式进行 编程以进行由系统使用的功能,并且被配置为将用于软件的数据存储在存 储器50中。例如,软件可通过网络以电子形式下载到控制台24,或者可在 非临时性有形介质诸如光学、磁性或电子存储器介质上提供软件。另选 地,可使用专用集成电路(ASIC)或任何合适类型的可编程数字硬件部件 来进行处理器42的功能中的一些或全部。
现在参考插图25。在一些实施方案中,导管22包括具有多个长条 (在下文图2和图3中详细示出)的远侧端部组件40,以及用于将远侧端 部组件40插入用于消融心脏26中的组织的目标位置的轴23。在消融规程 期间,医师30将导管22插入穿过躺在手术台29上的患者28的脉管系 统。医师30使用靠近导管22的近侧端部的操纵器32将远侧端部组件40 移动到心脏26中的目标位置,该操纵器连接到处理器42的接口电路。
在一些实施方案中,导管22包括位置跟踪系统的位置传感器39,该 位置传感器耦接到导管22的远侧端部,例如紧邻远侧端部组件40。在本示 例中,位置传感器39包括磁性位置传感器,但在其他实施方案中,可使用 任何其他合适类型的位置传感器(例如,除基于磁性的之外)。
现在参见回到图1的大体视图。在一些实施方案中,在远侧端部组件 40在心脏26中的导航期间,处理器42响应于来自外部场发生器36的磁场 而从磁位置传感器39接收信号,例如,用于测量远侧端部组件40在心脏 26中的位置。在一些实施方案中,控制台24包括被配置为驱动磁场发生器 36的驱动电路34。磁场发生器36放置在患者28外部的已知位置处,例 如,在工作台29下方。
在一些实施方案中,处理器42被配置为例如在控制台24的显示器46 上显示重叠在心脏26的图像44上的远侧端部组件40的跟踪位置。
使用外部磁场的位置感测方法在各种医疗应用中实现,例如,在由 BiosenseWebster Inc.(加利福尼亚州尔湾(Irvine,Calif.))制造的 CARTOTM系统中实现,并且详细地描述于美国专利5,391,199、6,690,963、6,484,118、6,239,724、6,618,612和6,332,089、PCT专利公布WO 96/05768、和美国专利申请公布2002/0065455 A1、2003/0120150 A1和2004/0068178 A1中,这些专利的公开内容全部以引用方式并入本文。
具有绝缘消融电极的远侧端部组件
图2是根据本发明的实施方案的处于扩张位置的远侧端部组件40的示 意性图解。
在一些实施方案中,远侧端部组件40包括由固体镍-钛合金(诸如固 体镍钛诺)或由任何其他合适的合金或物质制成的多个长条55。需注意, 镍钛诺被选择用于长条55,因为导电和足够柔性以适形于旨在被消融的组 织。因此,被选择用于长条55的任何其他材料必须导电和足够柔性以适形 于前述组织。
在一些实施方案中,远侧端部组件40的至少给定长条55以及通常每 个长条55具有导电区段,在本文中被称为区段66,该导电区段被配置为用 作消融电极以用于消融心脏26中的目标位置处的组织。
在一些实施方案中,区段66包括长条55的长度的至少六十 (60)%。区段66是非绝缘的(例如,如上所述导电的)并且被配置为与 心脏26的组织接触,并且在消融规程期间将射频(RF)脉冲施加到心脏组 织。
在其他实施方案中,区段66可包括长条55的长度的任何其他合适部 分。
在一些实施方案中,至少前述给定长条55并且通常远侧端部组件40 的每个长条55具有区段77,该区段是相应(例如,给定)长条55的长度 的至多四十(40)%。区段77是绝缘的并且定位在区段66和导管22的顶 点88之间。
在一些实施方案中,区段77被配置为在长条55的区段66之间,至少 在顶点88处电绝缘,该顶点通常与长条电绝缘。在其他实施方案中,顶点 88可包括导电材料并且可用作远侧端部组件40的附加消融电极。
在一些实施方案中,顶点88具有平坦表面89,该平坦表面通常(但 不一定)与轴23的轴线正交。
需注意,区段66具有介于约10mm和40mm之间的典型长度。因此, 当多个长条55正施加具有预定义能量和持续时间的脉冲时,远侧端部组件 40被配置为消融心脏26的目标位置处的组织中的约256mm2的区域。
在本公开和权利要求的上下文中,针对任何数值或范围的术语“约” 或“大致”指示合适的尺寸公差,该合适的尺寸公差允许部件的一部分或 集合为本文所述的预期目的起作用。更具体地,“约”或“大致”可指列 举值的值±20%的范围,例如“约90%”可指71%至99%的值范围。
在一些实施方案中,远侧端部组件40包括耦接元件(在本示例中为环 54),该耦接元件耦接到长条55的近侧端部并且被配置为螺纹连接在轴23 上以用于轴23与远侧端部组件40之间的耦接。需注意,每个长条55例如 经由从每个长条55的近侧端部延伸的线(未示出)电连接到导管22。因 此,处理器42可控制在控制台24与长条55的每个区段66之间的电连 接。这种受控且选择性的连接对于以下而言是重要的:经由选定长条55将 RF脉冲施加到心脏26的组织,并且类似地,从被放置成与心脏26的组织 接触的选定电极(例如,下文图3中所述的区段66或其他电极)接收心内 电信号。
在一些实施方案中,当医师30将导管22的远侧端部移动到心脏26中 的目标位置时,远侧端部组件40处于塌缩位置,其中所有长条55被拉 直。当远侧端部组件40定位在心脏26中的目标位置处时,医师30通常减 小环54与顶点88之间的距离(例如,通过朝向环54拉动顶点88,或通过 朝向顶点88推动环54,或使用任何其他技术),以便使远侧端部组件40处于其中长条55弯曲的扩张位置,如图2中所示。
在一些实施方案中,远侧端部组件40包括凸块止挡件91,该凸块止 挡件耦接到顶点88并且被配置为控制轴23与顶点88之间的最小距离。 即,凸块止挡件91固定到顶点88的近侧位置,使得凸块止挡件91面向轴 23的末端。在图2的示例中示出的扩张位置处,远侧端部组件40可具有轴 23的末端和凸块止挡件91之间的间隙距离92(沿纵向轴线70测量)。间隙距离92可为约1mm至13mm的任何值,这取决于导管的总直径。在一 个优选实施方案中,如沿纵向轴线70测量的,间隙92距离为约3mm。在 此类实施方案中,当医师30进一步减小环54与顶点88之间的距离时,凸 块止挡件91被配置为与轴23的末端接触,使得间隙距离92不存在(即, 等于零),并且由此限制轴23与顶点88之间的最小距离。换句话讲,凸 块止挡件91用作硬止挡件,该硬止挡件被配置为防止篮形远侧端部组件40 完全平坦,并且由此使镍钛诺基部屈曲。
在一些实施方案中,医师30可使用操纵器32以控制顶点88和环54 之间的距离,并且因此控制远侧端部组件40的扩张量。需注意,在将RF 脉冲施加到远侧端部组件40时,区段66用作消融电极并且将RF脉冲施加 到与其接触的组织,而区段77是绝缘的并且因此不将RF脉冲施加到组 织。此外,区段77在远侧端部组件40的区段66之间电隔离。在该配置中,处理器42可控制RF脉冲发生器以将一个或多个RF脉冲施加到第一 长条55的第一区段66,并且不将任何RF脉冲施加到第二长条55的第二 区段66。
耦接到远侧端部组件的顶点的诊断电极
图3是根据本发明的另一个实施方案的处于扩张位置的远侧端部组件 80的示意性图解。远侧端部组件80可替换例如图1的远侧端部组件40。
在一些实施方案中,远侧端部组件80包括多个长条56,诸如长条 56A、56D、56E和56F,其类似于上文图2的长条55并且分别具有绝缘区 段77A、77D、77E和77F。远侧端部组件80的每个长条56包括非绝缘区 段66,该非绝缘区段具有上文图2中所述的尺寸、机械属性和电属性。
在一些实施方案中,远侧端部组件80包括一个或多个诊断电极,在本 文中称为电极99。在本示例中,电极99包括(i)耦接到区段77A的电极 99A和99B、(ii)耦接到顶点88的表面89的电极99C、(iii)耦接到区段77D 的电极99D、(iv)耦接到区段77E的电极99E,以及(v)耦接到区段77F的电 极99F。在其他实施方案中,远侧端部组件80可包括使用任何合适的配置 来设置在任何区段77和/或顶点88上的其他合适数量的电极99。
在一些实施方案中,当被放置成与心脏26的组织接触时,电极99被 配置为感测组织中的电信号。在本公开的上下文和权利要求中,术语“感 测”、“标测”和“诊断”可互换使用,其中被配置用于感测心内信号的 感测电极(例如,电极99)产生用于标测和诊断心脏26的所考虑组织的信 号。在此类实施方案中,处理器42被配置为基于从电极99接收的心内信号产生心脏26的所考虑组织的电生理标测图。
在一些实施方案中,电极99A和99B附接到长条56A的区段77A,并 且被配置为感测其间的双极信号。
在一些实施方案中,可在电极99E和99F之间感测双极信号,该电极 分别耦接到长条56E和56F的区段77E和77F。除此之外或另选地,可在 耦接到表面89的电极99C与耦接到长条56D的区段77D的电极99D之间 感测双极信号。换句话讲,可在以下之间感测双极信号:(i)设置在单个长 条上的一对电极,和/或(ii)设置在两个不同长条上的一对电极,和/或(iii)耦 接到顶点88的电极和耦接到长条的电极,和/或(iv)以彼此相距预定距离耦 接到顶点88的一对电极(未示出),例如长条56a的区段77A上所示。
在其他实施方案中,上述电极99中的至少一者被配置为例如相对于参 考电极(未示出)感测单极信号,该参考电极被放置成与患者28体内的组 织接触或附接到患者28的皮肤(未示出)。
在一些实施方案中,使用任何合适的技术(诸如通过压接)将电极99 耦接到相应区段77。
在一些实施方案中,远侧端部组件80可包括电线和/或电迹线(均未 示出),其被配置为在每个电极99和处理器42之间电连接。电线可被分 组成在控制台24和轴23之间延伸的编织物,并且在轴23的远侧端部处, 每个电线被布线到相应电极99。
在一些实施方案中,当远侧端部组件80被放置成与心脏26的组织接 触时,电极99中的一者或多者被配置为响应于心脏26的组织中的感测电 势而生成电势梯度信号。位置传感器39被配置为响应于感测外部磁场而生 成位置信号,该位置传感器以与每个电极99相距已知距离固定在导管22 的远侧端部处。
在一些实施方案中,基于(i)从位置传感器39接收的位置信号和(ii)从 一个或多个电极99接收的信号,处理器42被配置为例如在显示器46上显 示由电极99在心脏26的组织中的相应位置处感测到的电势的电生理标测 图。
在一些实施方案中,基于心脏26的组织的电生理标测,医师30可将 选定长条56定位成与心脏26中的待消融组织接触。随后,医师30和/或处 理器42可控制系统20以施加RF脉冲以便消融心脏26的组织。
通过举例的方式示出了系统20的该特定配置以及远侧端部组件40和 80,以便示出通过本发明的实施方案解决的某些问题,并且展示这些实施 方案在增强此类消融系统的性能方面的应用。然而,本发明的实施方案决 不限于这种具体类型的示例性系统,并且本文所述的原理可类似地应用于 其他类型的医疗系统,诸如但不限于电外科系统和不可逆电穿孔(IRE)消 融系统。
制造篮形远侧端部组件
图4是根据本发明的实施方案的示意性地示出用于制造远侧端部组件40和80的方法的流程图。方法在长条接收步骤100处开始,其中接收由镍钛诺或由任何合适的镍-钛合金、或由适于用作消融电极的任何其他合金制成的多个长条55,如上文图2和图3中所述。
在涂覆步骤102处,用电绝缘层涂覆至少一个并且通常所有长条55的区段77。在远侧端部组件制造步骤104处,通过将(i)所有长条55的近侧端部耦接到环54,以及(ii)将位于所有长条55的远侧端部处的区段77耦接到导管顶点88来制造远侧端部组件40和80。
在其他实施方案中,在长条接收步骤100处,长条55中的一者或多者可能已经涂覆有前述电绝缘层,使得步骤102可能是冗余的,并且因此从方法中排除。
在仅在远侧端部组件80的制造中进行的电极耦接步骤106处,将一个或多个电极99耦接到顶点88和/或耦接到一个或多个长条55的区段77,并且将其连接到电线以用于在一个或多个(通常全部)电极99和处理器42之间传导信号,如上文图3中所述。需注意,在远侧端部组件40的制造中不进行步骤106。
在结束该方法的远侧端部组件耦接步骤108处,将远侧端部组件40或远侧端部组件80沿轴线70耦接到轴23,如上文图2和图3中所述。需注意,在远侧端部组件40的制造中,在执行步骤104之后,方法直接行进到步骤108而不执行步骤106,该步骤仅在远侧端部组件80的制造中进行。
概括地说,步骤100、102、104和108用于制造远侧端部组件40,并 且所有步骤100、102、104、106和108用于制造远侧端部组件80。
以举例的方式提供了图4的用于制造远侧端部组件40和80的该特定 方法,以便示出通过本发明的实施方案解决的某些问题,并且展示这些实 施方案在制造用于增强系统20的性能的远侧端部组件40和80方面的应 用。然而,本发明的实施方案决不限于这种特定类型的示例性制造过程, 并且本文所述的原理可类似地应用于系统20中或其他类型的医疗系统中使 用的其他类型的远侧端部组件,诸如但不限于电外科系统和不可逆电穿孔(IRE)消融系统。
使用篮形远侧端部组件来执行消融规程
图5是示意性地示出根据本发明的实施方案的用于使用远侧端部组件 80来消融组织的方法的流程图。方法在导管插入步骤200处开始,其中将 下文图3中详细描述的远侧端部组件80插入心脏26中。实质上,远侧端 部组件80的一个或多个长条56具有:(i)被配置用于消融心脏26的组织的 区段66,以及(ii)被配置用于感测心脏26的组织中的心内电信号的一个或 多个电极,诸如上文图3中所示的电极99A-99F。
在感测步骤202处,在将远侧端部组件80放置成紧邻心脏26中的目 标位置处的组织之后,医师30控制远侧端部组件80到扩张位置的扩张。 扩张可例如通过减小环54与顶点88之间的距离来进行。需注意,环54和 顶点88之间的最小距离由凸块止挡件91限制,如上文图1中所述。在一 些实施方案中,在感测步骤202处,将顶点88和区段77(例如,区段 77A、77D、77E和77F)中的至少一者且通常两者耦接到组织以用于感测 心内电信号。
在消融步骤204处,基于在步骤202中感测的信号,医师30操纵远侧 端部组件80并且将一个或多个长条56(例如,长条56A、56D、56E和 56F)的区段66耦接到组织以用于执行RF消融。需注意,在步骤202中, 将远侧端部组件80定位成使得轴线70大致与组织正交,以用于将顶点88 的表面89放置成与组织接触以进行感测。此外,在步骤204中,将远侧端 部组件80定位成使得轴线70大致平行于组织,使得一个或多个区段66被 放置成与组织接触并且从而消融组织。
在终止该方法的导管提取步骤206处,在结束消融之后,医师30控制 导管22以使远侧端部组件80塌缩(例如,通过增加环54和顶点88之间 的距离),并且随后将导管22从患者28的身体中抽取出来。
在其他实施方案中,处理器42可在消融规程之前或至少在步骤202之 前保持组织的电生理标测。在此类实施方案中,消融步骤204基于导管插 入步骤200之后的标测来进行,并且感测步骤202可在步骤204之后进 行,以便检查在步骤204之后是否需要施加附加RF脉冲来结束消融规程。 如果需要施加附加RF脉冲,则方法循环回到消融步骤204,之后进行感测 步骤202持续一次或多次迭代直到结束消融。
在另选的实施方案中,感测步骤202可在消融步骤204之前和之后执 行,以便感测用于控制如上所述的消融过程的心内电信号。
虽然本文所述的实施方案主要涉及篮形导管,但本文所述的技术也可 用于具有用于向组织施加能量的长条的任何其他合适的医疗探头。
应当理解,上述实施方案以举例的方式被引用,并且本发明不限于上 文具体示出和描述的内容。相反,本发明的范围包括上文描述的各种特征 的组合和子组合以及它们的变型和修改,本领域的技术人员在阅读上述描 述时将会想到该变型和修改,并且该变型和修改并未在现有技术中公开。 以引用方式并入本专利申请的文献被视为本申请的整体部分,不同的是如 果这些并入的文献中限定的任何术语与本说明书中明确或隐含地给出的定 义相冲突,则应仅考虑本说明书中的定义。
Claims (14)
1. 一种导管,包括:
轴,所述轴用于插入患者的器官中,所述轴沿纵向轴线延伸;以及
可扩张远侧端部组件,所述可扩张远侧端部组件耦接到所述轴和所述导管的顶点,并且包括多个长条,其中在所述多个长条中的至少给定长条中,所述给定长条的长度的至少60%是非绝缘的并且配置为与所述器官的组织进行接触并将射频(RF)脉冲施加到所述组织;以及
凸块止挡件,所述凸块止挡件耦接到所述顶点并且配置为限制所述轴和所述顶点之间的沿所述纵向轴线的最小距离,所述凸块止挡件与所述轴的末端分离,其中在所述末端和所述凸块止挡件之间存在轴向间隙。
2.根据权利要求1所述的导管,其中所述给定长条的所述长度的至多40%是绝缘的并且定位在所述非绝缘长度和所述顶点之间。
3.根据权利要求2所述的导管,其中所述绝缘长度涂覆有电绝缘层。
4.根据权利要求1所述的导管,其中至少所述给定长条包括镍-钛合金。
5.根据权利要求1所述的导管,其中所述顶点具有与所述轴的轴线正交的平坦表面。
6.根据权利要求5所述的导管,其中所述平坦表面是绝缘的。
7.根据权利要求1所述的导管,其中所述轴向间隙包括选自约1mm至约13mm的任何值的间隙距离。
8.一种用于制造导管的方法,所述方法包括:
接收多个长条,其中在所述多个长条中的至少给定长条中,所述给定长条的长度的至少60%是非绝缘的并且配置为与患者的器官的组织进行接触并将射频(RF)脉冲施加到所述组织;
将所述多个长条组装在一起以用于制造可扩张远侧端部组件;以及
将所述可扩张远侧端部组件耦接到轴和所述导管的顶点,其中凸块止挡件设置在所述轴和所述顶点之间以确保所述轴和所述顶点之间的间隙。
9.根据权利要求8所述的方法,其中所述给定长条的所述长度的至多40%是绝缘的,并且其中耦接所述可扩张远侧端部组件包括将所述绝缘长度耦接到所述顶点。
10.根据权利要求9所述的方法,并且包括用电绝缘层涂覆所述绝缘长度。
11.根据权利要求8所述的方法,其中至少所述给定长条包括镍-钛合金。
12.根据权利要求9所述的方法,其中将所述可扩张远侧端部组件耦接到所述顶点包括将所述长条的绝缘区段耦接到所述顶点的平坦表面,所述平坦表面与所述轴的轴线正交。
13.根据权利要求12所述的方法,其中所述平坦表面是绝缘的。
14.根据权利要求8所述的方法,其中耦接所述可扩张远侧端部组件包括将凸块止挡件耦接到所述顶点,所述凸块止挡件用于限制所述轴与所述顶点之间的最小距离。
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