CN114343831A - 具有球囊的篮状导管 - Google Patents

具有球囊的篮状导管 Download PDF

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CN114343831A
CN114343831A CN202111186445.XA CN202111186445A CN114343831A CN 114343831 A CN114343831 A CN 114343831A CN 202111186445 A CN202111186445 A CN 202111186445A CN 114343831 A CN114343831 A CN 114343831A
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A·戈瓦里
C·T·贝克勒
A·C·阿尔特曼
J·T·凯斯
K·J·埃雷拉
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Abstract

本发明题为“具有球囊的篮状导管”。在一个实施方案中，导管设备被构造成插入活体受检者的身体部分中，并且包括：细长可偏转元件，该细长可偏转元件包括远侧端部；可扩展篮状组件，该可扩展篮状组件设置在远侧端部处，并且包括多个筋条和设置在筋条上的多个电极；冲洗通道，该冲洗通道设置在细长可偏转元件中；以及可充胀球囊，该可充胀球囊设置在可扩展篮状组件中，并且包括与冲洗通道形成流体连接的多个冲洗孔。

Description

具有球囊的篮状导管
技术领域
本发明涉及医疗装置，并且具体地但并非排他性地涉及导管。
背景技术
大量的医疗规程涉及将探针诸如导管放置在患者体内。已经开发出位置感测系统来跟踪这类探针。磁性位置感测为本领域已知的一种方法。在磁性位置感测中，通常将磁场发生器放置在患者体外的已知位置处。探针的远侧端部内的磁场传感器响应于这些磁场生成电信号，这些电信号被处理以确定探针的远侧端部的坐标位置。这些方法和系统在美国专利5,391,199、6,690,963、6,484,118、6,239,724、6,618,612和6,332,089中、在PCT国际专利公布WO 1996/005768中以及在美国专利申请公布2002/006455和2003/0120150以及2004/0068178中有所描述。还可使用基于阻抗或电流的系统来跟踪位置。
心律失常的治疗是一种已证明其中这些类型的探针或导管极其有用的医疗规程。心律失常并且具体地讲心房纤颤一直为常见和危险的医学病症，在老年人中尤为如此。
心律失常的诊断和治疗包括标测心脏组织(尤其是心内膜)的电性质，以及通过施加能量来选择性地消融心脏组织。此类消融可停止或改变不需要的电信号从心脏的一个部分传播到另一部分。消融方法通过形成非导电消融灶来破坏不需要的电通路。已经公开了多种用于形成消融灶的能量递送形式，并且包括使用微波、激光和更常见的射频能量来沿心脏组织壁形成传导阻滞。在两步式手术(标测，之后进行消融)中，通常通过将包括一个或多个电传感器的导管推进到心脏中并采集多个点处的数据来感测和测量心脏内各个点处的电活动。然后利用这些数据来选择拟加以消融的心内膜目标区域。
电极导管已经普遍用于医疗实践多年。它们被用来刺激和标测心脏中的电活动，以及用来消融异常电活动的位点。使用时，将电极导管插入到主静脉或动脉例如股静脉中，并且随后引导到所关注的心脏腔室中。典型的消融手术涉及将在其远侧端部具有一个或多个电极的导管插入到心脏腔室中。可提供通常用粘附至患者的皮肤上的参考电极，或者可使用设置在心脏中或附近的第二导管来提供参考电极。RF(射频)电流被施加在消融导管的导管电极与无关电极(其可为导管电极中的一个电极)之间，并且电流流经这些电极之间的介质(即，血液和组织)。电流的分布可取决于与血液相比电极表面与组织接触的量，血液具有比组织更高的导电率。由于组织的电阻，发生组织的加热。组织被充分加热而致使心脏组织中的细胞破坏，从而导致在心脏组织内形成不导电的消融灶。在一些申请中，可进行不可逆电穿孔以消融组织。
Steinke等人的美国专利公布2019/0117301描述了一种用于治疗患者血管的导管和导管系统，其包括具有径向可扩展结构的细长柔性导管主体。当结构扩展时，多个电极或其他电外科能量递送表面可径向接合待处理的材料。靠近导管主体的远侧端部的材料检测器可测量周向材料分布，并且功率源选择性地激励电极以偏心地治疗身体内腔。
授予Gelfand等人的美国专利9,757,180描述了用于治疗患有至少部分地与增强的外周化学反射或强化的交感神经激活相关联的交感神经介导的疾病的患者的系统、装置和方法。这些治疗包括消融一种或多种外周化学受体或相关联的传入神经，以减少或去除来自外周化学受体的传入神经信号。
授予Eliason等人的美国专利9,474,486描述了电生理电极导管，其包括具有近侧端部和远侧端部的细长可变形轴以及联接到轴的远侧端部的篮状电极组件。篮状电极组件具有近侧端部和远侧端部，并且被构造成呈现压缩状态和扩展状态。电极组件还包括一个或多个管状筋条和多个导体，该管状筋条具有设置于其上的多个电极。多个导体中的每个导体穿过管状筋条从多个电极中的对应电极延伸到篮状电极组件的近侧端部。管状筋条被构造成在扩展状态下呈现非平面(例如，扭曲或螺旋)形状。
授予Bencini等人的美国专利9,060,756描述了一种消融身体组织的方法，该方法包括：(a)将冷冻疗法球囊导管的可充胀球囊部分定位在患者体内的治疗部位处，并使可充胀球囊部分充胀；(b)采用设置在可充胀球囊部分的可扩展表面上的电极，以电表征治疗部位处的身体组织；(c)通过向可充胀球囊部分供应冷冻治疗剂以使身体组织冷却到治疗温度来消融身体组织；(d)采用电极来确定消融是否在身体组织中引起期望的电变化；以及(e)当确定消融没有引起期望的电变化时，重复(c)和(d)。
授予Basu等人的美国专利10,362,952描述了一种用于诊断和消融组织的导管，该导管具有稳定的脊电极组件。稳定的脊电极组件具有在其近侧端部处固定到导管主体的至少两个脊以及固定在相邻脊的近侧端部的远侧位置之间的至少一个拴系件。脊具有塌缩布置和扩展布置，在该塌缩布置中，脊大致沿导管主体的纵向轴线布置，在该扩展布置中，每个脊的至少一部分从纵向轴线径向向外弯曲，并且至少一个拴系件对相邻脊施加张力。
发明内容
根据本公开的实施方案，提供了一种导管设备，该导管设备被构造成插入活体受检者的身体部分中，并且包括：细长可偏转元件，该细长可偏转元件包括远侧端部；可扩展篮状组件，该可扩展篮状组件设置在远侧端部处，并且包括多个筋条和设置在筋条上的多个电极；冲洗通道，该冲洗通道设置在细长可偏转元件中；以及可充胀球囊，该可充胀球囊设置在可扩展篮状组件中，并且包括与冲洗通道形成流体连接的多个冲洗孔。
另外，根据本公开的实施方案，筋条围绕可充胀球囊周向设置。
再者，根据本公开的实施方案，可充胀球囊被构造成完全充胀，使得完全充胀的球囊与筋条的面向可充胀球囊的至少百分之三十的内表面区域之间存在至少一毫米的间隙。
另外，根据本公开的实施方案，筋条中的每个筋条包括内表面和外表面，电极设置在筋条中的相应筋条的内表面和外表面上。
此外，根据本公开的实施方案，可充胀球囊和可扩展篮状组件包括远侧端部，设备还包括支撑元件，该支撑元件连接到可充胀球囊的远侧端部和可扩展篮状组件的远侧端部，并且被构造成保持完全充胀的球囊与面向可充胀球囊的筋条的面向可充胀球囊的至少百分之三十的内表面区域之间的至少一毫米的间隙。
另外，根据本公开的实施方案，筋条中的相应筋条包含镍钛诺。
再者，根据本公开的实施方案，相应筋条中的电极包含镍钛诺。
另外，根据本公开的实施方案，筋条中的相应筋条包括相应的聚合物柔性电路。
此外，根据本公开的实施方案，至少百分之九十的电极设置在可扩展篮状组件的区域中，可充胀球囊的至少百分之九十的冲洗孔设置在区域的更近侧或更远侧。
另外，根据本公开的实施方案，电极设置在可扩展篮状组件的区域中，可充胀球囊的冲洗孔设置在区域的更近侧或更远侧。
根据本公开的另一个实施方案，还提供了一种导管设备，该导管设备被构造成插入活体受检者的身体部分中，并且包括：细长可偏转元件，该细长可偏转元件包括远侧端部；可扩展篮状组件，该可扩展篮状组件设置在远侧端部处，并且包括多个筋条和设置在筋条上的多个电极；以及可充胀球囊，该可充胀球囊设置在可扩展篮状组件中，并且被构造成完全充胀，使得完全充胀的球囊与筋条的面向可充胀球囊的至少百分之三十的内表面区域之间存在至少一毫米的间隙。
再者，根据本公开的实施方案，筋条围绕可充胀球囊周向设置。
另外，根据本公开的实施方案，筋条中的每个筋条包括内表面和外表面，电极设置在筋条中的相应筋条的内表面和外表面上。
此外，根据本公开的实施方案，可充胀球囊和可扩展篮状组件包括远侧端部，设备还包括支撑元件，该支撑元件连接到可充胀球囊的远侧端部和可扩展篮状组件的远侧端部，并且被构造成保持完全充胀的球囊与面向可充胀球囊的筋条的面向可充胀球囊的至少百分之三十的内表面区域之间的至少一毫米的间隙。
另外，根据本公开的实施方案，筋条中的相应筋条包含镍钛诺。
再者，根据本公开的实施方案，相应筋条中的电极包含镍钛诺。
另外，根据本公开的实施方案，筋条中的相应筋条包括相应的聚合物柔性电路。
根据本公开的又一个实施方案，提供了一种医疗系统，该医疗系统包括导管和消融功率发生器，该消融功率发生器被构造成连接到导管，并且将电信号施加到电极中的至少一个电极以消融身体部分的组织，该导管被构造成插入活体受检者的身体部分中，并且包括：细长可偏转元件，该细长可偏转元件包括远侧端部；可扩展篮状组件，该可扩展篮状组件设置在远侧端部处，并且包括多个筋条和设置在筋条上的多个电极；以及可充胀球囊，该可充胀球囊设置在可扩展篮状组件中。
此外，根据本公开的实施方案，导管包括设置在细长可偏转元件中的冲洗通道，并且其中可充胀球囊包括与冲洗通道形成流体连接的多个冲洗孔。
另外，根据本公开的实施方案，可充胀球囊被构造成完全充胀，使得完全充胀的球囊与筋条的面向可充胀球囊的至少百分之三十的内表面区域之间存在至少一毫米的间隙。
再者，根据本公开的实施方案，筋条中的每个筋条包括内表面和外表面，电极设置在筋条中的相应筋条的内表面和外表面上。
另外，根据本公开的实施方案，至少百分之九十的电极设置在可扩展篮状组件的区域中，可充胀球囊的至少百分之九十的冲洗孔设置在区域的更近侧或更远侧。
此外，根据本公开的实施方案，电极设置在可扩展篮状组件的区域中，可充胀球囊的冲洗孔设置在区域的更近侧或更远侧。
另外，根据本公开的实施方案，消融功率发生器被构造成在电极之间施加电信号以对身体部分的组织执行不可逆的电穿孔。
附图说明
根据以下详细说明结合附图将理解本发明，其中：
图1为根据本发明的实施方案构造和操作的医疗系统的示意图；
图2为根据本发明的实施方案构造和操作的导管的示意图；
图3A为图2的导管沿线A:A的剖视图；
图3B为图2所示的装置的另选实施方案的剖视图，其中球囊未联接到篮状构件的远侧端部；
图4为图3A的框A内的导管的更详细的剖视图；
图5为图3A的框B内的导管的更详细的剖视图；并且
图6为根据本发明的另选实施方案构造和操作的导管的剖视图。
具体实施方式
概述
冲洗通常与导管一起使用，以在医疗规程诸如例如射频(RF)消融期间提供冷却。用于在篮式导管中提供冲洗的一种解决方案是使冲洗通道穿过导管，该冲洗通道终止于篮状体中间。然后可将冲洗流体通过冲洗通道泵送到冲洗通道的远侧端部，在该远侧端部处，冲洗流体离开并且向篮状体的区域中的组织提供冷却以及局部稀释血液。然而，冲洗不是很好地定向的，并且虽然它可对于不产生大量热量的电穿孔而言足够，但通常不足以减少在RF消融期间产生的热。篮状导管遇到的另一个问题在于，篮状体在插入体内期间需要呈塌缩或半塌缩形式，然后在体腔中部署成其扩展形式。由于冲洗通道可能干扰篮状体的扩展和塌缩，因此能够使篮状体塌缩和扩展的需求为提供有效冲洗增加了另外的难题。篮状导管(无论是用于消融还是诊断)所遇到的另外的问题在于，在使用期间，已经发现血凝块可能在篮状体内产生并在该处滞留。
本发明的实施方案通过提供具有在其上包括电极的可扩展篮状组件的导管来解决上述问题，其中可充胀球囊安装在可扩展篮状组件中。当部署时，球囊在扩展的篮状组件中充胀，并且用于从篮状组件的内部取代血液以防止在篮状组件内产生血凝块。另外，球囊可包括冲洗孔，冲洗流体通过这些冲洗孔被泵送以在使用中冷却电极。球囊允许相对于电极策略性地放置冲洗孔，以增强使用期间的冷却。
在一些实施方案中，完全充胀的球囊接触扩展的篮状组件的内表面。当完全充胀的球囊与扩展的篮状组件的内表面之间不存在或存在极小间隙时，防止了血液进入篮状组件的内部，从而防止血凝块。在其他实施方案中，完全充胀的球囊与扩展的篮状组件的内表面之间存在间隙。当存在间隙时，电极可被更有效地冲洗(取决于冲洗和电极构型)，并且篮状体的内表面可包括电极，从而增加可用于消融的电极表面积。
在一些实施方案中，导管包括细长可偏转元件，以及设置在可偏转元件的远侧端部的可扩展篮状组件。篮状组件包括筋条和放置在筋条上的电极。导管包括设置在可扩展篮状组件中的可充胀球囊，其中筋条围绕可充胀球囊周向设置。
在一些实施方案中，筋条中的至少一些筋条包含镍钛诺。在一些实施方案中，相应筋条中的电极包含镍钛诺。例如，将镍钛诺筋条用绝缘覆盖件选择性地覆盖以使电极暴露，或者将镍钛诺筋条覆盖并在覆盖件中开口出窗口以显露电极。在其他实施方案中，筋条包括相应的聚合物柔性电路。可使用沿着每个筋条的至少给定长度延伸的镍钛诺支撑件来支撑柔性电路。
在一些实施方案中，导管包括设置在细长可偏转元件中的冲洗通道，并且可充胀球囊包括与冲洗通道形成流体连接的冲洗孔。在一些实施方案中，电极设置在可扩展篮状组件的区域中，并且可充胀球囊的冲洗孔(当球囊完全充胀时)设置在电极区域的更近侧或更远侧(当篮状体完全扩展时)。
在一些实施方案中，导管包括设置在细长可偏转元件中的冲洗通道，并且可充胀球囊包括与冲洗通道形成流体连接的冲洗孔。在一些实施方案中，至少百分之九十的电极设置在可扩展篮状组件的区域中，并且可充胀球囊的至少百分之九十的冲洗孔(当球囊完全充胀时)设置在电极区域的更近侧或更远侧(当篮状体完全扩展时)。
在其他实施方案中，可充胀球囊不包括冲洗孔。在那些实施方案中，冲洗可任选地使用其他方法执行。
在一些实施方案中，可充胀球囊被构造成完全充胀，使得完全充胀的球囊与(完全扩展的篮状组件的)筋条的面向可充胀球囊的至少部分(例如，至少百分之三十)内表面区域之间存在至少一毫米的间隙。球囊可任选地包括冲洗孔。在一些实施方案中，支撑元件连接到可充胀球囊的远侧端部和可扩展篮状组件的远侧端部，并且保持完全充胀的球囊与完全扩展的篮状组件的筋条之间的间隙。在一些实施方案中，当保持间隙时，电极可设置在每个筋条的内表面和外表面上，从而增加用于消融的电极表面积。内表面上的电极可与外表面上的电极集成，或者连接到外表面上的电极。在一些实施方案中，完全充胀的球囊接触筋条。
系统可包括连接到导管的消融功率发生器，并且将电信号施加到一个或多个电极以消融身体部分的组织。在一些实施方案中，消融功率发生器在电极之间施加电信号以对身体部分的组织执行不可逆的电穿孔。
系统描述
现在参考图1，其为根据本发明的实施方案构造和操作的医疗系统20的示意图。系统20包括被构造成插入活体受检者(例如，患者28)的身体部分中的导管40。医师30通过以下方式将导管40(例如，由美国加州欧文市的Biosense Webster,Inc.生产的篮状导管)导航到患者28的心脏26中的目标位置：使用靠近导管40近侧端部的操纵器32操纵导管40的伸长可偏转元件22和/或从护套23偏转。在图示实施方案中，医师30使用导管40来执行心腔的电解剖标测和心脏组织的消融。
导管40包括可扩展篮状组件35，该可扩展篮状组件以折叠构型穿过护套23插入，并且仅在导管40退出护套23之后，篮状组件35才恢复其预期的功能形状。通过将篮状组件35约束在折叠构型中，护套23还用于在其到达目标位置的途中使血管创伤最小化。
导管40包括多个电极48，用于感测电活动和/或施加消融功率以消融身体部分的组织。导管40可在可偏转元件22的远侧边缘处(即，在篮状组件35的近侧边缘处)结合磁传感器(图1中未示出)。通常，尽管并非必须，仅以举例的方式，磁传感器可为三轴传感器(TAS)或双轴传感器(DAS)或SAS，这基于例如大小考虑。第二磁传感器(未示出)可以包括在组件35上的任何合适的位置。仅以举例的方式，第二磁传感器可为TAS、DAS或SAS，这基于例如大小考虑。设置在组件35上的磁传感器和电极48通过穿过可偏转元件22的导线连接到控制台24中的各种驱动电路。
在一些实施方案中，系统20包括磁感测子系统，以通过从介于磁传感器之间的距离估计篮状组件35的伸长来估计导管40的篮状组件35的椭圆度以及其在心脏26的心腔内部的伸长/回缩状态。将患者28放置在由包含一个或多个磁场发生器线圈42的垫产生的磁场中，该磁场发生器线圈由单元43驱动。由线圈42产生的磁场将交变磁场传输到身体部分所在的区域中。所传输的交变磁场在磁传感器中生成信号，该信号指示位置和/或方向。所生成的信号被传输到控制台24，并且成为到处理电路41的相应的电输入。
使用外部磁场和磁传感器的位置和/或方向感测方法在各种医疗应用中实现，例如在由Biosense-Webster生产的
Figure BDA0003299410580000081
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WO96/05768以及美国专利申请公布2002/0065455A1、2003/0120150A1和2004/0068178A1中。
处理电路41(通常为通用计算机的一部分)经由合适的前端和接口电路44被进一步地连接，以从身体表面电极49接收信号。处理电路41通过穿过线缆39延伸到患者28的胸部的导线连接到身体表面电极49。
在一个实施方案中，处理电路41响应于导管40的计算位置坐标向显示器27呈现导管40的至少一部分和标测的身体部分的表示31。
处理电路41通常用软件进行编程以执行本文所述的功能。该软件可通过网络以电子形式被下载到计算机，例如或者其可另选地或另外地设置和/或存储在非临时性有形介质(诸如磁存储器、光存储器或电子存储器)上。
医疗系统20还可包括消融功率发生器69(诸如RF信号发生器)，该消融功率发生器被构造成连接到导管40，并且向电极48施加电信号。医疗系统20还可包括：冲洗贮存器71，该冲洗贮存器被构造成储存冲洗流体；以及泵73，该泵被构造成连接到冲洗贮存器71和导管40，并且将冲洗流体从冲洗贮存器71泵送通过导管40的冲洗管，如参考图2、图3和图5更详细所述。
图1所示的示例性例证完全是为了概念清晰而选择的。为简单和清晰起见，图1仅示出了与本发明所公开的技术有关的元件。系统20通常包括附加模块和元件，该附加模块和元件与所公开的技术不直接相关，并且因此该附加模块和元件从图1和对应的描述中被有意地省略。系统20的元件以及本文所述的方法可进一步地应用于例如控制心脏26的组织的消融。
现在参见图2，其为根据本发明的实施方案构造和操作的导管40的示意图。
导管40被构造成插入活体受检者的身体部分(例如，心脏26(图1))。导管40的可偏转元件22具有远侧端部33。可偏转元件22可由任何合适的材料例如聚氨酯或聚醚嵌段酰胺制成。组件35设置在可偏转元件22远侧，并且可经由远侧端部33处的近侧联接构件50连接到可偏转元件22。近侧联接构件50通常包括中空管并且可由任何合适的材料形成，例如但不限于具有或不具有玻璃填料的聚碳酸酯、具有或不具有玻璃填料的聚醚醚酮(PEEK)、聚酰亚胺、聚酰胺、或具有或不具有玻璃填料的聚醚酰亚胺(PEI)。联接构件50可形成为可偏转元件22的整体部分或形成为篮状组件35的部分或形成为与可偏转元件22和篮状组件35连接的单独元件。如本文所用，术语“远侧”意指参考部件更远离操作者，而“近侧”意指参考部件更靠近导管的操作者。
组件35可包括多个筋条55(为了简单起见，仅标记了一个)，诸如具有设置在筋条55上的电极48(为了简单起见，仅标记了一些)的柔性条。在图2的实施方案中，每个筋条55包括单个电极48。组件35可包括任何合适数量的电极48，每个筋条55具有多个电极48。
在一些实施方案中，筋条55中的至少一些筋条包含镍钛诺。在一些实施方案中，筋条55中的相应筋条的电极48包含镍钛诺。在其他实施方案中，筋条55中的相应筋条包括相应的聚合物柔性电路。可使用沿着每个筋条55的至少一定长度延伸的镍钛诺支撑件来支撑柔性电路。
在图2的实施方案中，每个筋条55由镍钛诺形成，其在筋条55的远侧区域和近侧区域57(为了简单起见，仅标记了一些)中选择性地覆盖有绝缘材料，留出筋条55的中心区域59(为了简单起见，仅标记了一些)作为电活性区域，以例如执行标测和/或执行消融或电穿孔。组件35的结构可以变化。例如，筋条55(或其他筋条)可包括柔性印刷电路板(PCB)、或任何合适形状的记忆合金。
在一些实施方案中，篮状组件35的松弛状态为扩展部署形式。篮状组件35被构造成当导管40在护套23(图1)中回缩时塌缩成塌缩形式，并且被构造成当导管40从护套23移除时扩展成扩展部署形式。可通过由任何合适的弹性材料诸如镍钛诺或PEI形成筋条55来设定篮状组件35的松弛形状。在其他实施方案中，可扩展篮状组件35的松弛状态为塌缩形式，并且可扩展篮状组件35通过使牵拉元件(例如牵拉线)回缩而扩展，该牵拉元件设置在细长可偏转元件22的长度中并且连接到可扩展篮状组件35的远侧端部。
导管40包括设置在可扩展篮状组件35中的可充胀球囊65。筋条55通常围绕可充胀球囊65周向设置。在图2所示的实施方案中，可充胀球囊65完全充胀，使得其接触完全扩展的可扩展篮状组件35的筋条55(沿每个筋条55的长度的90％或更多)。在参考图6更详细描述的其他实施方案中，在完全充胀的球囊65与完全扩展的可扩展篮状组件35的筋条55的至少30％的内表面区域之间存在至少1mm的间隙。
在一些实施方案中，导管40包括设置在细长可偏转元件22中的冲洗通道67(图3A和5所示)。在图2所示的实施方案中，示出了包括多个冲洗孔75的可充胀球囊65。冲洗孔75与冲洗通道67流体连接(图3A)。
在一些实施方案中，冲洗孔75设置在可充胀球囊65的一个或多个区域中。在其他实施方案中，冲洗孔75设置在可充胀球囊65上。在一些实施方案中，冲洗孔75主要设置在可充胀球囊65的不靠近电极48的区域中。在一些实施方案中，电极48设置在可扩展篮状组件35的给定区域中，并且当可充胀球囊65和可扩展篮状组件35完全扩展时，可充胀球囊65的冲洗孔75设置在给定区域的更近侧或更远侧(相对于垂直于非偏转导管40的轴线的平面)。在一些实施方案中，至少百分之九十的电极48设置在可扩展篮状组件35的给定区域中，并且当可充胀球囊65和可扩展篮状组件35完全扩展时，可充胀球囊65的至少百分之九十的冲洗孔75设置在给定区域的更近侧或更远侧(相对于垂直于非偏转导管40的轴线的平面)。
在其他实施方案中，可充胀球囊65不包括冲洗孔。在这些实施方案中，冲洗可任选地使用任何合适的方法执行。
消融功率发生器69(图1)被构造成连接到导管40，并且将电信号施加到电极48中的至少一个电极(例如，两个或更多个电极48之间，或者一个或多个电极48与设置在细长可偏转元件22的远侧端部的近侧电极77之间，或与参考电极之间)以消融身体部分(例如心脏26)的组织。在一些实施方案中，消融功率发生器69被构造成在一个或多个电极48之间施加电信号以对身体部分的组织执行不可逆的电穿孔。可充胀球囊65有助于防止电信号主要传导通过可扩展篮状组件35的中心，而是增强电信号传导通过身体部分的组织。
可充胀球囊65可包含生物相容性材料，诸如聚氨酯、聚醚嵌段酰胺、有机硅、尼龙或聚酯。通常，球囊将具有0.0005”至0.005”的壁厚。冲洗孔75可具有任何合适的直径，例如在约0.01mm至0.125mm的范围内，例如0.075mm。可充胀球囊65可包括任何合适数量的离散孔75，例如1至200个，例如50个。在一些实施方案中，冲洗孔75可包括激光或机械钻出的孔。
泵73(图1)被构造成将冲洗流体从冲洗贮存器71(图1)经由冲洗通道67(图3A)泵送到可充胀球囊65中并通过冲洗孔75。冲洗流体用于使可充胀球囊65充胀。在可充胀球囊65不包括冲洗孔的实施方案中，可充胀球囊65可以用任何合适的流体诸如盐水或气体进行充胀。
现在参考图3A，其为图2的导管40的沿线A:A的剖视图。图3A(框A内部)示出翻折并连接到远侧连接器85的可充胀球囊65和筋条55的远侧端部(为了简单起见，仅标记了两个)，在一些实施方案中，远侧连接器为管(例如，聚合物管)或嵌条(例如，聚合物嵌条)。参考图4更详细地描述了远侧连接器85。
在一些实施方案中，筋条55和/或可充胀球囊65可连接到远侧连接器85而不翻折，使得当篮状组件35塌缩时，筋条55沿其长度接近平坦形成物。
图3A(框B内部)示出筋条55的近侧端部连接到近侧联接构件50的内表面。可充胀球囊65的近侧端部连接到近侧连接器79(例如，聚合物嵌条)，该近侧连接器固定到近侧联接构件50。参考图5更详细地描述了近侧连接器79。图3A还示出了冲洗通道67(其延伸穿过可偏转元件22、近侧联接构件50和近侧连接器79中的狭槽83)和位置传感器81(例如，磁位置传感器)。
在图3B中，示出了另选的导管端部执行器40’，其具有球囊65’，该球囊被布置成使得远侧球囊部分65a不固定或联接到导管远侧连接器85。也就是说，球囊65’具有自由远侧球囊部分65a(即，未连接到远侧连接器85)，其中近侧球囊部分65b联接到近侧联接构件50，使得球囊65’自由地适形于导管脊55的内边界。图3B中的球囊65’在那些方面与图3A中的球囊65相比有所不同。
现在参考图4，其为图3A的框A内部的导管40的更详细剖视图。筋条55固定到远侧连接器85。可充胀球囊65的远侧端部固定在筋条55与远侧固定环87之间。粘合剂或环氧树脂层89设置在远侧固定环87与远侧连接器85之间，从而将筋条55和可充胀球囊65固定在适当的位置。在一些实施方案中，可充胀球囊65和筋条55可利用压力配合和/或任何合适的粘合剂固定在远侧连接器85与远侧固定环87之间。远侧连接器85和近侧固定环87可由任何合适的材料形成，例如但不限于具有或不具有玻璃填料的聚碳酸酯、具有或不具有玻璃填料的PEEK、或具有或不具有玻璃填料的PEI。远侧连接器85还用作嵌条以塞住可充胀球囊65的远侧端部。
现在参考图5，其为图3A或图3B的框B内部的导管40的更详细剖视图。
图5示出了近侧连接器79和狭槽83。狭槽83允许冲洗通道67-3和电线(例如，用于连接到一个或多个电极和/或传感器)横穿近侧连接器79。冲洗通道67-2连接到冲洗通道67-3，该冲洗通道较窄使得其适配在狭槽83中。可充胀球囊65利用例如粘合剂连接到近侧连接器79。可充胀球囊65可使用任何合适的连接方法连接到近侧连接器79。
筋条55的近侧端部固定在近侧联接构件50和位置传感器81以及冲洗通道67-2之间。筋条55可利用压力配合和/或任何合适的粘合剂固定到近侧联接构件50。冲洗通道67-2连接到设置在细长可偏转元件22中的冲洗通道67-1。
近侧连接器79可由任何合适的材料形成，例如但不限于具有或不具有玻璃填料的聚碳酸酯、具有或不具有玻璃填料的PEEK、或具有或不具有玻璃填料的PEI。
现在参见图6，其为根据本发明的另选实施方案构造和操作的导管100的剖视图。除了以下差别之外，导管100与图1至图5的导管40基本上相同。
导管100包括可充胀球囊102，该可充胀球囊被构造成完全充胀，使得完全充胀的球囊102与筋条55的面向可充胀球囊102的至少部分(例如，至少百分之三十)内表面区域之间存在至少一毫米的间隙104。“内表面”被定义为筋条55的面向可充胀球囊102的表面。
在一些实施方案中，可充胀球囊102包括冲洗孔(未示出)。在其他实施方案中，可充胀球囊102不包括冲洗孔。
在一些实施方案中，导管100包括支撑元件，诸如连接到可充胀球囊102的远侧端部和可扩展篮状组件35的远侧端部的远侧连接器85(和/或连接到可充胀球囊102的近侧端部和可扩展篮状组件35的近侧端部的近侧连接器79)，其被构造成保持完全充胀的球囊102与筋条55的面向可充胀球囊102的至少部分(例如至少百分之三十)内表面区域之间的至少一毫米的间隙104。
在一些实施方案中，电极48设置在筋条55中的相应筋条的内表面和外表面上。使用电极48的内表面和外表面为消融提供了更大表面积。设置在筋条55中的一者的内表面上的电极48中的一者可电连接到该筋条55的外表面上的对应电极48。在一些实施方案中，单个电极可从内表面延伸到外表面(例如，当筋条55由导体诸如镍钛诺形成时)。
如本文所用，针对任何数值或范围的术语“约”或“大约”指示允许部件或元件的集合实现如本文所述的其预期要达到的目的的合适的尺寸公差。更具体地，“约”或“大约”可指列举值的值±20％的范围，例如“约90％”可指72％至108％的值范围。
为清晰起见，在独立实施方案的上下文中描述的本发明的各种特征部也可在单个实施方案中组合提供。相反地，为简明起见，本发明的各种特征部在单个实施方案的上下文中进行描述，也可单独地或以任何合适的子组合形式提供。
上述实施方案以举例的方式被引用，并且本发明不受上文具体示出和描述的内容的限制。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。

Claims (25)

1.一种导管设备，所述导管设备构造成插入活体受检者的身体部分中，并且包括：
细长可偏转元件，所述细长可偏转元件包括远侧端部；
可扩展篮状组件，所述可扩展篮状组件设置在所述远侧端部处，并且包括多个筋条和设置在所述筋条上的多个电极；
冲洗通道，所述冲洗通道设置在所述细长可偏转元件中；和
可充胀球囊，所述可充胀球囊设置在所述可扩展篮状组件中，并且包括与所述冲洗通道成流体连接的多个冲洗孔。
2.一种导管设备，所述导管设备构造成插入活体受检者的身体部分中，所述设备包括：
细长可偏转元件，所述细长可偏转元件包括沿着纵向轴线延伸的远侧端部；
可扩展篮状组件，所述可扩展篮状组件设置为靠近所述远侧端部，并且包括从所述可偏转元件的所述远侧端部延伸到远侧脊连接器的多个筋条以及设置在所述筋条上的多个电极；
可充胀球囊，所述可充胀球囊设置在所述可扩展篮状组件中，所述球囊包括联接到所述远侧端部的近侧球囊部分和靠近所述远侧脊连接器的自由脱离的远侧球囊部分。
3.根据权利要求1或权利要求2所述的设备，其中所述筋条围绕所述可充胀球囊周向设置。
4.根据权利要求1或权利要求2所述的设备，其中所述可充胀球囊构造成完全充胀，使得所述完全充胀的球囊与所述筋条的面向所述可充胀球囊的至少百分之三十的内表面区域之间存在至少一毫米的间隙。
5.根据权利要求4所述的设备，其中所述筋条中的每个筋条包括内表面和外表面，所述电极设置在所述筋条中的相应筋条的所述内表面和所述外表面上。
6.根据权利要求4所述的设备，其中所述可充胀球囊和所述可扩展篮状组件包括远侧端部，所述设备还包括支撑元件，所述支撑元件连接到所述可充胀球囊的所述远侧端部和所述可扩展篮状组件的所述远侧端部，所述支撑元件构造成保持所述完全充胀的球囊与所述筋条的面向所述可充胀球囊的至少百分之三十的内表面区域之间的至少一毫米的间隙。
7.根据权利要求1所述的设备，其中所述筋条中的相应筋条包含镍钛诺。
8.根据权利要求7所述的设备，其中所述相应筋条的所述电极包含镍钛诺。
9.根据权利要求1所述的设备，其中所述筋条中的相应筋条包括相应的聚合物柔性电路。
10.根据权利要求1所述的设备，其中至少百分之九十的所述电极设置在所述可扩展篮状组件的区域中，所述可充胀球囊的至少百分之九十的所述冲洗孔设置在所述区域的更近侧或更远侧。
11.根据权利要求1所述的设备，其中所述电极设置在所述可扩展篮状组件的区域中，所述可充胀球囊的所述冲洗孔设置在所述区域的更近侧或更远侧。
12.一种导管设备，所述导管设备构造成插入活体受检者的身体部分中，并且包括：
细长可偏转元件，所述细长可偏转元件包括远侧端部；
可扩展篮状组件，所述可扩展篮状组件设置在所述远侧端部处，并且包括多个筋条和设置在所述筋条上的多个电极；和
可充胀球囊，所述可充胀球囊设置在所述可扩展篮状组件中，并且构造成完全充胀，使得所述完全充胀的球囊与所述筋条的面向所述可充胀球囊的至少百分之三十的内表面区域之间存在至少一毫米的间隙。
13.根据权利要求12所述的设备，其中所述筋条围绕所述可充胀球囊周向设置。
14.根据权利要求12所述的设备，其中所述筋条中的每个筋条包括内表面和外表面，所述电极设置在所述筋条中的相应筋条的所述内表面和所述外表面上。
15.根据权利要求12所述的设备，其中所述可充胀球囊和所述可扩展篮状组件包括远侧端部，所述设备还包括支撑元件，所述支撑元件连接到所述可充胀球囊的所述远侧端部和所述可扩展篮状组件的所述远侧端部，所述支撑元件构造成保持所述完全充胀的球囊与所述筋条的面向所述可充胀球囊的至少百分之三十的内表面区域之间的至少一毫米的间隙。
16.根据权利要求12所述的设备，其中所述筋条中的相应筋条包含镍钛诺。
17.根据权利要求16所述的设备，其中所述相应筋条的所述电极包含镍钛诺。
18.根据权利要求12所述的设备，其中所述筋条中的相应筋条包括相应的聚合物柔性电路。
19.一种医疗系统，所述医疗系统包括：
导管，所述导管构造成插入活体受检者的身体部分中，并且包括：
细长可偏转元件，所述细长可偏转元件包括远侧端部；
可扩展篮状组件，所述可扩展篮状组件设置在所述远侧端部处，并且包括多个筋条和设置在所述筋条上的多个电极；和
可充胀球囊，所述可充胀球囊设置在所述可扩展篮状组件中；和
消融功率发生器，所述消融功率发生器构造成连接到所述导管，并且将电信号施加到所述电极中的至少一个电极以消融所述身体部分的组织。
20.根据权利要求19所述的系统，其中所述导管包括设置在所述细长可偏转元件中的冲洗通道，并且其中所述可充胀球囊包括与所述冲洗通道成流体连接的多个冲洗孔。
21.根据权利要求19所述的系统，其中所述可充胀球囊构造成完全充胀，使得所述完全充胀的球囊与所述筋条的面向所述可充胀球囊的至少百分之三十的内表面区域之间存在至少一毫米的间隙。
22.根据权利要求19所述的系统，其中所述筋条中的每个筋条包括内表面和外表面，所述电极设置在所述筋条中的相应筋条的所述内表面和所述外表面上。
23.根据权利要求19所述的系统，其中至少百分之九十的所述电极设置在所述可扩展篮状组件的区域中，所述可充胀球囊的至少百分之九十的所述冲洗孔设置在所述区域的更近侧或更远侧。
24.根据权利要求19所述的系统，其中所述电极设置在所述可扩展篮状组件的区域中，所述可充胀球囊的所述冲洗孔设置在所述区域的更近侧或更远侧。
25.根据权利要求19所述的系统，其中所述消融功率发生器构造成在所述电极之间施加电信号以对所述身体部分的所述组织执行不可逆的电穿孔。
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