CN110547864A - 增强型大直径球囊导管 - Google Patents

增强型大直径球囊导管 Download PDF

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Publication number
CN110547864A
CN110547864A CN201910462090.9A CN201910462090A CN110547864A CN 110547864 A CN110547864 A CN 110547864A CN 201910462090 A CN201910462090 A CN 201910462090A CN 110547864 A CN110547864 A CN 110547864A
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China
Prior art keywords
balloon
flexible substrate
balloon catheter
membrane
electrodes
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CN201910462090.9A
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Inventor
A.戈瓦里
C.T.贝克勒
J.T.凯耶斯
K.J.赫瑞拉
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Biosense Webster Israel Ltd
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Biosense Webster Israel Ltd
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Publication of CN110547864A publication Critical patent/CN110547864A/zh
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    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
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Abstract

本发明提供了一种球囊导管，该球囊导管包括轴、由可膨胀膜制成的球囊、柔性基底、一个或多个电极、以及一个或多个不透射线标记。轴被构造成插入患者的心脏中。球囊装配在轴的远端处。柔性基底设置在膜上。一个或多个电极设置在柔性基底上，并且具有鱼骨构型。一个或多个不透射线标记联接到可膨胀膜，其中一个或多个不透射线标记包括螺线形图案，使得当可膨胀膜塌缩成压缩构型或折叠构型时，不透射线标记顺应柔性基底而折叠。

Description

增强型大直径球囊导管
技术领域
本发明整体涉及医疗探头，具体地讲，涉及球囊导管。
背景技术
各种已知的导管设计具有安装在其远端处的可膨胀消融球囊。例如，美国专利申请公布2011/0118632描述了一种心脏消融装置，该装置通过将超声波引导并聚焦到环状消融区域中来治疗心房纤颤。可以在不参照装置与肺静脉或孔口之间的接合的情况下，对消融装置进行引导和定位。在一个实施方案中，在充气状态下，装置位于最大直径约32mm的结构球囊内。
又如，美国专利申请公布2010/0114269描述了一种医疗装置，该医疗装置可包括具有近侧部分和远侧部分的导管主体、设置在细长主体内的流体注入内腔、以及设置在细长主体内的导丝内腔。限定与流体注入内腔流体连通的腔体的末端部分可联接到导丝内腔的远端，并且可膨胀元件可联接到导管主体的远侧部分、以及末端部分，使得可膨胀元件与流体注入内腔流体连通。成形元件可至少部分地围绕可膨胀元件，其中成形元件可构造成第一几何构型和第二几何构型。第一几何构型可包括大约23mm的直径，第二几何构型可包括大约32mm的直径。
美国专利申请公布2017/0312022描述了一种用于肺静脉口的灌注式球囊导管，该球囊导管包括柔性电路电极组件，当球囊充气时，该柔性电路电极组件适于与肺静脉口的周边接触。该球囊导管适用于诊断和治疗应用和规程，并且可以与套索导管或病灶导管一起使用。该柔性电路电极组件包括：基底；该基底的外表面上的接触电极，该接触电极具有“鱼骨”构型，该构型具有纵向细长部分和多个横向指状物；该基底的内表面上的布线电极；以及延伸穿过该基底，并且电耦合接触电极和布线电极的导电通孔。具有排出区的微电极策略性地相对于所述电极定位。所述电极还可分为电极部分。
美国专利申请公布2002/0160134描述了一种具有主球囊的球囊导管、以及一种导向球囊系统，该系统以可视化方式指示放置在人体内的主球囊的充气状态。小的导向球囊利用基本上与主球囊相同的材料，并且具有与主球囊基本上相同的结构而方便地通过吹塑进行制造。导向球囊可用于具有球囊的导管、或带管箍的管，其中该球囊或管箍由高弹性材料制成。主球囊和导向球囊在三种不同充气压力下的直径分别为：25cm H2O下为31mm和16mm、在34cm H2O下为32mm和17mm、以及在56cm H2O下为34mm和18mm。
发明内容
我们在设计直径大于28mm的大直径球囊导管时遇到了某些问题。在以下方面遇到一些问题：将此类较大尺寸的球囊(即，“卷曲球囊”)压缩成足够小的构型，使得卷曲球囊可在手术期间通过狭窄静脉(经由大约5法式至大约15法式直径的导管)传送至心脏。我们能够为这些问题设计各种解决方案，本专利申请阐述并说明了这些解决方案。
在一种方法中，我们设计了一种球囊导管，其包括轴、由可膨胀膜制成的球囊、柔性基底、一个或多个电极、以及一个或多个不透射线标记。轴被构造成插入患者的心脏中。球囊装配在轴的远端处。柔性基底设置在膜上。一个或多个电极设置在柔性基底上，并且具有鱼骨构型。一个或多个不透射线标记联接到可膨胀膜，其中一个或多个不透射线标记包括螺线形图案，使得当可膨胀膜塌缩成压缩构型或折叠构型时，不透射线标记顺应柔性基底而折叠。
在一些实施方案中，球囊导管还包括设置在膜上的冲洗孔，一些冲洗孔分布在覆盖有电极的区域上，其它冲洗孔分布在覆盖有电极的区域之间。
在一些实施方案中，不透射线标记包括至少第一标记和第二标记，这些标记以不同形状图案化，以在X射线成像时指示球囊导管的取向。
在一个实施方案中，球囊导管还包括设置在球囊近侧的磁性位置传感器。
在另一实施方案中，球囊导管还包括设置在膜和柔性基底之间的纱线。
在一些实施方案中，该纱线选自超高分子量纤维或液晶聚合物纤维中的一种。
在一个实施方案中，柔性基底包括图案化形貌，该图案化形貌被构造成增加柔性基底对膜的粘附性。
根据本发明的一个实施方案，还提供了一种用于制造球囊导管的方法，该方法包括提供被构造成插入患者心脏中的轴。该轴的远端配有由可膨胀膜制成的球囊。柔性基底设置在膜上。具有鱼骨构型的一个或多个电极设置在柔性基底上。具有螺线形图案的一个或多个不透射线标记设置在柔性基底上。电极和螺线形不透射线标记顺应处于压缩构型的膜。
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是根据本发明的实施方案的基于导管的定位-跟踪与消融系统的示意性图解，该系统包括射频(RF)消融球囊；
图2是根据本发明的实施方案的图1的球囊导管的示意性图解；
图3是根据本发明的实施方案的柔性电路电极组件的详细示意性俯视图解；
图4是根据本发明的实施方案的柔性电路电极组件的俯视图解；
图5是根据本发明的实施方案的不透射线标记的空间布置的示意性俯视图解；以及
图6是根据本发明的实施方案，如通过X射线成像将见的，球囊上的不透射线标记的图形化体积透视图。
具体实施方式
概述
可膨胀消融球囊可装配在导管的远端处，该导管穿过心血管系统并插入心脏中，例如用于消融肺静脉口。球囊应足够大以便不会无意中进入静脉，但也必须以足够紧凑的形式填充，使球囊可以穿过狭窄血管。另一个挑战是确保此类球囊安全塌缩与回缩回导管护套中，以便在治疗后将球囊从体内移除。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±10％的范围，例如“约90％”可指81％至99％的值范围。另外，如本文所用，术语“患者”、“宿主”、“用户”和“受检者”是指任何人或动物受检者，并不旨在将系统或方法局限于人使用，但本主题发明在人类患者中的使用代表优选的实施方案。
下文所述的本发明的实施方案可实现：消融球囊可靠地塌缩与回缩到护套中，且直径足够大而不会进入肺静脉。在一些实施方案中，充气时，所需的球囊直径设定为大约32毫米。设置在球囊膜(即壁)上的元件，诸如电极和不透射线标记，被构造成在球囊塌缩时承受剥离力，在此期间，较大的膜拉伸和/或形成折叠。
具体地讲，这些元素被设计成，以适形的方式拉伸和/或折叠，以便适应以下应力：可能以其它方式引起这些元件从膜上剥离以及/或者以其它方式防止球囊充分塌缩的应力。除此之外或另选地，这些元件中的至少一些元件被设计成限制应力，诸如可能由于过度拉伸而产生的应力。
这些元件中的一个元件为不透射线标记，其设置在柔性基底上，柔性基底其本身附接到球囊膜(例如，胶合在球囊壁的外表面上)。不透射线标记、柔性基底和膜全部被设计并彼此附接，以便按如下方式拉伸和/或折叠在一起：使球囊可以塌缩，并将球囊安全地抽出到导管的护套中。
在一些实施方案中，不透射线标记被设计成具有螺线形图案，使不透射线标记能够以适形方式拉伸和/或折叠(即，当可膨胀膜塌缩成压缩或折叠构型时，顺应柔性基底而折叠)。出于同样的理由，该柔性基底包括图案化形貌，诸如十字形图案形貌、或矩阵、或其它盲孔/盲形图案，其被构造成增加柔性基底对球囊膜的粘附性，并在胶合到膜上之后，增加抓握面积。这样，柔性基底和膜以彼此适形的方式拉伸和/或折叠，从而在球囊塌缩时保持完整。
在本发明的一个实施方案中，一个或多个不透射线标记以多个形状图案化，用以指示球囊导管的取向，从而为操作者提供定向和取向引导，如下文进一步详述。在一些实施方案中，磁性位置传感器设置在导管轴内，刚好在球囊近侧，使得磁性位置跟踪系统可协助进行球囊导航。
在一个实施方案中，设置在柔性基底上的消融电极具有鱼骨构型，该鱼骨构型具有纵向(即，平行于轴的远端)细长部分、以及多个横向指状物。该构型有利于电极的拉伸和/或折叠，使得其在球囊塌缩以及其回缩回护套期间不会剥离。
在一些实施方案中，冲洗孔分布在整个膜上。一些冲洗孔分布在覆盖有电极的区域上，而其它冲洗孔分布在覆盖有电极的区域之间。在球囊表面上的冲洗孔的均匀分布可确保组织和血液在消融期间更可靠地与均匀地冷却。
所公开的解决方案使大球囊可以塌缩成足够紧凑的形式，以将球囊安全地缩回导管护套中，而这一点按其它方式可能非常难以实现，并且在临床手术期间试图执行可能不安全。所公开的增强型球囊直径足够大，以安全地消融肺静脉口，并随后安全地从患者的心脏缩回。
系统说明
图1是根据本发明的实施方案的基于导管的定位-跟踪与消融系统20的示意性图解，该系统包括RF消融球囊40。系统20包括导管21，其中，如插图25所示，导管21的轴22的远端22a通过护套23而插入躺在工作台29上的患者28的心脏26中。如插图25进一步所示，远端22a包括磁性传感器39，该磁性传感器容纳在正好在球囊40左侧的远端22a内。
导管21的近端连接到控制台24。在本文所述的实施方案中，导管21可用于任何合适的治疗目的和/或诊断目的，诸如心脏26中的组织的电感测和/或消融。
在远端22a在心脏26中的导航期间，控制台24响应于来自外部场发生器36的磁场，接收来自磁性传感器39的信号，例如，用于测量消融球囊40在心脏中的位置，并且任选地，将跟踪位置呈现在显示器27上。磁场发生器36放置在患者28外部的已知位置处，例如，在患者的工作台29下方。控制台24还包括被构造成驱动磁场发生器36的驱动电路34。
在一个实施方案中，从位置传感器39接收的位置信号指示消融球囊40在位置跟踪与消融系统20的坐标系中的位置。使用外部磁场的位置感测方法在各种医疗应用场景中实现，例如，在由Biosense Webster Inc.(加利福尼亚州尔湾(Irvine,California))生产的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、以及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，这些专利的公开内容全部以引用方式并入本文。
内科医生30通过使用靠近导管近端的操纵器32来操纵轴22，而将轴22的远端导航至心脏26中的目标位置，以及/或者使其相对于护套23偏转。在轴22的插入期间，球囊40由护套23保持在塌缩构型中。通过将球囊40包含在折叠构型中，护套23还用于使目标位置沿途的血管创伤最小化。
控制台24包括：处理器41，通常为通用计算机，具有合适的前端；和接口电路38，用于接收来自导管21的信号，以及用于经由导管21对心脏26进行治疗，并用于控制系统20的其它部件。处理器41通常包括通用计算机，该通用计算机具有经编程以执行本文所述功能的软件。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(诸如磁学、光学或电子存储器)上。
图1所示的示例性构型是完全为了使概念清楚而选择的。可使用其它系统部件和设置类似地应用本发明所公开的技术。例如，系统20可包括其它部件并执行非心脏消融治疗。
增强型大直径球囊导管
图2是根据本发明的实施方案的图1的球囊导管40的示意性图解。如图所示，球囊40装配在从护套23突起的(轴22的)远端22a。磁性位置传感器39容纳在正好在球囊40近侧的远端22a内。可膨胀球囊40具有生物相容性材料的外壁或膜43，诸如，由诸如聚对苯二甲酸乙二酯(PET)、聚氨酯、或等塑料形成的材料。在柔性基底44上，消融电极46设置在球囊40的整个周边。
球囊40具有远端、以及限定纵向轴线的近端。在一些实施方案中，通过“球囊推进器”杆(未示出)而使球囊40膨胀与回缩(即塌缩)。该杆可以从轴22向外延伸，以将球囊40纵向伸长成椭圆形。其可抽出以提供具有球形形状的球囊。球囊推进器杆是主要机构，用于在球形构型和椭圆形构型之间改变球囊40的形状，同时用盐水填充球囊进一步将球囊表皮紧固成球形。
在一些实施方案中，球囊40包括冲洗孔47a和47b，通过该冲洗孔灌入盐水溶液，以在消融期间冷却组织和血液。孔47a位于由电极46覆盖的区域中，而孔47b位于由电极46覆盖的区域之间的膜43上。
在一些实施方案中，不透射线标记52以不同的螺线形状图案化。在本发明的一个实施方案中，不同形状的不透射线标记52提供取向和定向引导，如下文进一步详述。设置有两个或更多个彼此形式不同的不透射线标记物的电生理导管描述于美国专利申请15/939，154中，该专利提交于2018年3月28日，标题为“用于2-D可视化场景下的多电极识别和取向的具有可区别电极的灌注式电生理导管(Irrigated Electrophysiology Catheter withDistinguishable Electrodes for Multi-Electrode Identification and OrientationUnder 2-D Visualization)”，该专利申请被授予本专利申请的受让人，并且该专利申请的公开内容以引用的方式并入本文。
充气时，球囊40的直径由位于膜43外部的赤道45来限定，其中赤道位于垂直于远端22a的轴线的平面中。在一些实施方案中，充气时，球囊赤道直径(即，赤道45的直径)测得大约三十二毫米。
图2的插图42示出了处于塌缩状态(例如，准备好回缩到护套23中)的球囊40的剖视图。如插图42所示，当球囊塌缩时，膜43和柔性基底44尽管大体上被延伸杆伸长为细长的，但仍可形成折叠。此类折叠对柔性基底44造成压力，或者对设置在柔性基底44上的元件造成压力，这可导致剥离。在球囊直径增加时，随着球囊被迫塌缩，会发生更明显的折叠，从而增加剥离力。此外，如果一些设置的元件在轴向上或在横向上太刚性，则它们会阻碍球囊塌缩到足够的程度而安全地回缩到护套23中。在本发明的一些实施方案中，设置在膜上的元件经设计，使得它们和膜将以相互共形的方式轴向拉伸和/或横向折叠，如在图3的详细描述中所解释的那样，以便避免上述问题。
灌注式球囊消融导管描述于标题为“具有柔性电路电极组件的灌注式球囊导管(Irrigated balloon catheter with flexible circuit electrode assembly)”的美国专利公布2017/0312022中，其全部内容以引用的方式并入本文。
图2所示的示例性插图完全是为了使概念清晰而选择的。球囊40的其它尺寸及其部件(诸如，消融电极46)的各种构型是可能的。充气时，球囊40的赤道直径可大于或小于三十二毫米。
图3是根据本发明的实施方案的柔性电路电极组件的详细示意性俯视图解。在一个实施方案中，消融电极46具有“鱼骨”的形式，从而有利地增加电极46与组织的周向或赤道接触表面。同时，鱼骨形式更容易以适形方式进行拉伸和/或折叠，以便使球囊40可以在远端22a周围塌缩成足够紧密的形式。
如图3所示，不透射线标记或标记物52以螺线形形状图案化，以便使不透射线标记52在球囊40塌缩时，以与柔性基底44适形的方式进行折叠。另外参见冲洗孔47a，其位于未被电极46覆盖的区域中。
在一个实施方案中，由液晶聚合物(LCP)(例如，)或超高分子量聚乙烯(UHMWPE)(例如，)制成的纱线或纤维60在膜43与柔性基底44之间，从柔性基底44一端延伸至另一端。由于纱线60的高弹性模量，在球囊40塌缩的同时，该纱线或纤维限制任何可能以其它方式导致剥离的轴向拉伸。该纱线还防止柔性基底44在其窄的远侧尾部撕裂，该远侧尾部不具有任何金属以限制伸长。该纱线实现了用球囊推进器杆对内腔(通过围绕膜43)施加很大的远侧力，以便在不损坏附接到柔性基底44上的任何电路的情况下，抽空内部盐水溶液。
柔性基底44的边缘区域44a的放大图示出了放入边缘区域44a中的十字形图案50形貌(即，“华夫”图案)，用以在将柔性基底44胶合到膜43上之后，增加柔性基底44对膜43的粘附性。华夫图案可通过增加粘合剂的抓握区域而提供必要的粘附性，这两者均增强了粘结性，并抑制了在球囊40塌缩以回缩到护套23中之时所产生的作用于基底44的剥离力。如图3进一步所示，在柔性基底44的放大图中，具有多个穿孔50的图案，其中穿孔50被构造成容纳粘合剂，用于将基底44附连到膜43上。
图3所示的示例性俯视图完全是为了使概念清晰而选择的。可使用其它材料，例如，纱线60可以由对位芳纶制成。在图4所示的不透射线标记52的一个可选实施方案中，举例说明了用于抑制剥离的不同溶液，如下所述。
图4是根据本发明的实施方案的柔性电路电极组件的俯视图解。如图所示，不透射线标记53分成不透射线标记53a和53b，以便使不透射线标记更容易在纵向上拉伸。另外，不透射线标记53a的标记是中空三角形的形式，以在X射线成像时指示取向。
图5是根据本发明的实施方案的不透射线标记52的空间布置的示意性俯视图解。还可看到柔性基底44的浅灰色轮廓。为了指示取向，所示的十个不透射线标记52中的一些标记以独特特征图案化。如图5所示，不透射线标记52(见编号1-10)可以分成第一类标记和第二类标记。第一类标记，诸如标记52a，具有不同的特征。第二类标记与另一类标记相同，例如，全部包括平直线。标记52以这种方式进行设计，为内科医生30指示电极46的取向，并且以这种方式，指示在心脏26心室内的作为一个整体的球囊40。例如，不透射线标记52a包括中空箭头的图案，而不透射线标记52b包括完全箭头图案。
图5所示的示例完全是为了使概念清晰而选择的。可设计和使用其它图案。图5中具有独特图案的不透射线标记的数量和布置方式以举例的方式提出，并且一般可变化。
图6是根据本发明的实施方案，如通过X射线成像将见的，球囊上的不透射线标记52的图形化体积透视图。如图6所示，球囊40的X射线图像可分辨不透射线标记52a和52b，为内科医生30指示球囊40的空间取向感。
尽管本文所述的实施方案主要针对心脏球囊导管，但本文所述的方法和系统也可以用于其它应用，诸如耳鼻喉或神经内科手术中。
因此应当理解，上面描述的实施方案以举例的方式被引用，并且本发明不限于上文特定示出和描述的内容。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所述变型和修改，并且所述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 (13)

1.一种球囊导管，包括：
轴，所述轴被构造成插入患者的心脏中；
由可膨胀膜制成的球囊，所述球囊装配在所述轴的远端处；
柔性基底，所述柔性基底设置在所述膜上；
一个或多个电极，所述一个或多个电极设置在所述柔性基底上并且具有鱼骨构型；以及
一个或多个不透射线标记，所述一个或多个不透射线标记联接到所述可膨胀膜，所述一个或多个不透射线标记包括螺线形图案，使得在所述可膨胀膜塌缩成压缩或折叠构型时，所述不透射线标记顺应柔性基底而折叠。
2.根据权利要求1所述的球囊导管，并且包括设置在所述膜上的冲洗孔，其中一些所述冲洗孔分布在覆盖有所述电极的区域上，并且其它所述冲洗孔分布在覆盖有所述电极的区域之间。
3.根据权利要求1所述的球囊导管，其中所述不透射线标记包括至少第一标记和第二标记，所述第一标记和所述第二标记以不同形状图案化，以在X射线成像时指示所述球囊导管的取向。
4.根据权利要求1所述的球囊导管，并且包括设置在所述球囊近侧的磁性位置传感器。
5.根据权利要求1所述的球囊导管，并且包括设置在所述膜和所述柔性基底之间的纱线。
6.根据权利要求5所述的球囊导管，其中所述纱线选自超高分子量纤维或液晶聚合物纤维中的一种。
7.根据权利要求1所述的球囊导管，其中所述柔性基底包括图案化形貌，所述图案化形貌被构造成增加所述柔性基底对所述膜的粘附性。
8.一种用于制造球囊导管的方法，所述方法包括：
提供轴，所述轴被构造成插入患者的心脏中；
在所述轴的远端处，装配由可膨胀膜制成的球囊；
在所述膜上设置柔性基底；
将具有鱼骨构型的一个或多个电极设置在所述柔性基底上；
将一个或多个具有螺线形图案的不透射线标记设置在所述柔性基底上；以及
使所述电极和螺线形不透射线标记与处于压缩构型的所述膜相贴合。
9.根据权利要求8所述的方法，并且包括将冲洗孔设置在所述膜上，其中一些所述冲洗孔分布在覆盖有所述电极的区域上，并且其它所述冲洗孔分布在覆盖有所述电极的区域之间。
10.根据权利要求8所述的方法，其中设置所述不透射线标记包括设置至少第一不透射线标记和第二不透射线标记，所述至少第一不透射线标记和第二不透射线标记以不同形状图案化，以在X射线成像时指示所述球囊导管的取向。
11.根据权利要求8所述的方法，并且包括将磁性位置传感器设置在所述球囊近侧。
12.根据权利要求8所述的方法，并且包括将纱线设置在所述膜和所述柔性基底之间。
13.根据权利要求8所述的方法，并且包括通过在所述柔性基底中包括图案化形貌，来增加所述柔性基底对所述膜的粘附性。
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