CN106604675A - 具有耦接到消融尖头的柔性电极组件的医疗设备 - Google Patents

具有耦接到消融尖头的柔性电极组件的医疗设备 Download PDF

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CN106604675A
CN106604675A CN201580047274.9A CN201580047274A CN106604675A CN 106604675 A CN106604675 A CN 106604675A CN 201580047274 A CN201580047274 A CN 201580047274A CN 106604675 A CN106604675 A CN 106604675A
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conduit
electrode assemblie
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distal ablation
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德斯蒙德·张
约翰·C·波托斯凯
安德鲁·T·马雷茨基
艾萨克·J·金姆
马克·D·米里吉安
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Boston Scientific Scimed Inc
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Abstract

公开了医疗设备和用于制造和使用医疗设备的方法。示例性医疗设备可以包括用于心脏标测和/或消融的导管。该导管可以包括细长导管轴，细长导管轴具有能够消融组织的远端消融电极区域。电极组件可以耦接到远端消融电极区域。电极组件可以包括柔性电路，柔性电路具有设置在其上的一个或多个电极。

Description

具有耦接到消融尖头的柔性电极组件的医疗设备
相关申请的交叉引用
本申请要求2014年10月24日递交的临时申请号62/068,334的优先权，通过引用的方式将其整体并入本文。
技术领域
本公开涉及医疗设备以及用于制造医疗设备的方法。本公开更具体地涉及心脏标测和/或消融。
背景技术
已经开发了各种体内医疗设备以用于医疗用途例如血管内用途。这些设备中的一些包括引导线、导管等等。这些设备通过多种不同的制造方法中的任意一种制造并且可以根据多种方法中的任意一种来使用。在已知的医疗设备和方法中，每个都具有特定优点和缺点。现在需要提供可替换的医疗设备以及用于制造和使用医疗设备的可替换的方法。
发明内容
本公开提供了用于医疗设备的设计、材料、制造方法和使用替换。一种示例性导管可以包括用于心脏标测和/或消融的导管。该导管包括：具有远端消融电极区域的细长导管轴；耦接到远端消融电极区域的电极组件；以及其中，电极组件包括柔性电路，柔性电路具有设置在其上的一个或多个电极。
可替换地或另外地，任意以上实施例中，远端消融电极区域具有形成在其中的开口，以及其中，电极组件延伸经过开口。
可替换地或另外地，任意以上实施例中，电极组件包括沿远端消融电极区域的远端设置的区域。
可替换地或另外地，任意以上实施例中，电极组件包括多个臂部区域，以及其中，每个臂部区域包括至少一个电极。
可替换地或另外地，任意以上实施例中，电极组件包括三个或更多个臂部区域。
可替换地或另外地，任意以上实施例中，电极组件包括四个或更多个臂部区域。
可替换地或另外地，任意以上实施例中，电极组件包括能够将电极组件机械地固定到远端消融电极区域的机械锁定端区域。
可替换地或另外地，任意以上实施例中，远端消融电极区域具有形成在其中的开口，以及其中，机械锁定端区域延伸经过开口。
可替换地或另外地，任意以上实施例中，导管轴包括内部通道，其中，远端消融电极区域包括第一开口和第二开口，以及其中，电极组件沿内部通道延伸经过第一开口，沿远端消融电极区域的外表面延伸并且经过第二开口。
可替换地或另外地，任意以上实施例中，电极组件粘性结合到远端消融电极区域。
可替换地或另外地，任意以上实施例中，电极组件包括一个或多个电极区域以及一个或多个电绝缘区域。
可替换地或另外地，任意以上实施例中，电极组件围绕远端消融电极区域圆周延伸。
可替换地或另外地，任意以上实施例中，电极组件设计为从远端消融电极区域径向地向外弓形弯曲。
可替换地或另外地，任意以上实施例中，远端消融电极区域包括铂消融尖头电极。
还公开了一种用于制造医疗设备的方法。该方法可以包括：将电极组件插入形成在导管的远端消融尖头中的通道中；其中，电极组件包括柔性电路，柔性电路具有设置在其上的一个或多个电极；其中，远端消融尖头包括第一开口和第二开口；以及延伸电极组件经过第一开口，沿远端消融尖头的外表面延伸并且经过第二开口。
用于心脏标测和/或消融的导管的另一个实施例可以包括：具有内部通道和远端区域的细长导管轴；能够对设置在远端区域处的组织进行消融的远端消融尖头；耦接到远端消融尖头的电极组件；其中，电极组件包括具有设置在其上的一个或多个电极的柔性电路；其中，远端消融电极区域包括第一开口和第二开口；其中，电极组件沿内部通道延伸经过第一开口，沿远端消融尖头的外表面延伸并且经过第二开口。
可替换地或另外地，任意以上实施例中，电极组件包括沿远端消融电极区域的远端设置的区域。
可替换地或另外地，任意以上实施例中，电极组件包括多个臂部区域，以及其中，每个臂部区域包括至少一个电极。
可替换地或另外地，任意以上实施例中，电极组件包括能够将电极组件机械地固定到远端消融尖头的机械锁定端区域。
可替换地或另外地，任意以上实施例中，机械锁定端区域延伸经过第一开口和/或第二开口。
一些实施例的以上摘要不是意图描述每个所公开的实施例或本公开的每个实现。下文的附图的详细描述更具体地例示了这些实施例。
虽然公开了多个实施例，但是通过显示并且描述了本发明的说明性实施例的以下详细描述，本发明的其他实施例对于本领域熟练技术人员而言将是显而易见的。因此，附图和详细描述应被视为是说明性而不是限制性的。
附图说明
结合附图来考虑以下详细描述可以更完整地理解本公开，其中：
图1是示例性心脏标测和/或消融系统的平面图；
图2是示例性心脏标测和/或消融系统的一部分的部分剖面透视图；
图3是示例性电极组件的透视图；
图4-图6示出了用于将电极组件固定到心脏标测和/或消融系统的一种示例性方法；
图7是示例性电极组件的侧视图；
图8是示例性心脏标测和/或消融系统的一部分的部分剖面透视图；
图9是示例性电极组件的侧视图；
图10是示例性心脏标测和/或消融系统的一部分的部分剖面透视图；
图11是示例性电极组件的侧视图；
图12是示例性心脏标测和/或消融系统的一部分的部分剖面透视图；
图13是示例性电极组件的侧视图；
图14是示例性心脏标测和/或消融系统的一部分的部分剖面透视图；
图15是示例性电极组件的侧视图；
图16是圆柱形配置的示例性电极组件的透视图；
图17是示例性心脏标测和/或消融系统的一部分的侧视图；
图18是示例性电极组件的侧视图；
图19是圆柱形配置的示例性电极组件的透视图；
图20是示例性心脏标测和/或消融系统的一部分的侧视图；
图21是示例性电极组件的透视图；
图22是示例性心脏标测和/或消融系统的一部分的部分剖面透视图；
图23是示例性电极组件的透视图；
图24是示例性心脏标测和/或消融系统的一部分的部分剖面透视图；
图25是示例性电极组件的透视图；
图26是示例性心脏标测和/或消融系统的一部分的部分剖面透视图；
图27是示例性心脏标测和/或消融系统的一部分的侧视图；
图28是经过线条28-28取得的横截面视图；
图29是经过线条28-28取得的可替换的横截面视图；
图30是示例性心脏标测和/或消融系统的一部分的侧视图；
图31是示例性心脏标测和/或消融系统的一部分的侧视图；
图32是示例性心脏标测和/或消融系统的一部分的侧视图；
图33是图32中所示的示例性心脏标测和/或消融系统的端视图；
图34是示例性心脏标测和/或消融系统的一部分的侧视图；
图35是所示的示例性心脏标测和/或消融系统的端视图；
图36是示例性心脏标测和/或消融系统的一部分的侧视图；以及
图37是示例性心脏标测和/或消融系统的一部分的侧视图。
虽然本公开可以改成各种修改和替换形式，但是其细节通过附图中的实例显示并且将详细描述。然而，应该理解，不意图将本发明限于所述具体实施例。相反，本发明覆盖落入本公开的精神和范围中的全部修改、等效物和替换物。
具体实施方式
对于下文限定的术语，应该应用这些定义，除非在权利要求或者本说明书的其他地方给出了不同的定义。
本文假设所以数值通过术语“大约”来修饰，不管是否明确指示。术语“大约”通常涉及本领域熟练技术人员会视为与所引用的值等效的数字范围(例如具有相同的功能或结果)。在许多实例中，术语“大约”可以包括进位到最接近的重要数的数字。
通过端点记载的数值范围包括在该范围内的全部数字(例如1到5包括1、1.5、2、2.75、3、3.80、4和5)。
如说明书和所附权利要求中所使用的，单数形式“一”、“一个”和“该”包括复数个指代物，除非其内容明确指示不是这样。如说明书和所附权利要求中所使用的，术语“或”通常用于意味着包括“和/或”，除非其内容明确指示不是这样。
注意到在说明书中指代的“一个实施例”、“一些实施例”、“其他实施例”等等指示所述实施例可以包括一个或多个具体特征、结构和/或特性。然而，该记载无须意味着全部实施例包括该具体特征、结构和/或特性。另外，当结合一个实施例来描述具体特征、结构和/或特性时，应该理解可以结合无论是否明确描述的其他实施例来使用该具体特征、结构和/或特性，除非明确相反地说明。
应该参考附图来阅读下文的详细描述，其中在不同的附图中类似的元件被相同标号。无需按比例描绘的附图描述了说明性的实施例并且不是意图限制本发明的范围。
图1示出了示例性心脏标测和/或消融系统10。如图1中所示，系统10可以包括细长构件或导管轴12、RF生成器14和处理器16(例如标测处理器、消融处理器和/或其他处理器)。作为实例，轴12可以可操作地耦接到RF生成器14和处理器16中的至少一个或多个(例如一个或两个)。可替换地或另外地，除了轴12之外的可用于应用消融能量到目标区域和/或标测目标区域的设备可以可操作地耦接到RF生成器14和处理器16中的至少一个或多个。RF生成器14可能能够传递和/或可以配置为以受控的方式传递消融能量到轴12，以便消融由处理器16识别的目标区域点。虽然处理器16和RF生成器14可以显示为离散的组件，但是这些组件或者组件特征可以合并到单个设备中。系统10可以根据希望包括一个或多个其他特征中的任意一个。
在至少一些实施例中，轴12可以包括把手18，把手18可以具有致动器20(例如控制手柄或其他致动器)。例如，把手18(例如近端把手)可以定位在轴12的近端。作为实例，轴12可以包括具有远端部的柔性主体，远端部可以包括一个或多个电极。轴12的远端部可以例如包括多个环形电极22、远端消融尖头电极24和设置或者否则定位在远端消融尖头电极24中和/或与远端消融尖头电极24电绝缘的多个微电极或微电极组件26中的一个或多个。
轴12可以是可调整的以助于导航患者的脉管系统或者导航其他内腔。作为实例，可以通过操作致动器20来偏转轴12的远端部13以实现调节轴12。在一些实例中，可以偏转轴12的远端部13以将远端消融尖头电极24和/或微电极组件26相邻目标组织定位或者定位轴12的远端部13用于另一个合适的目的。另外或者可替换地，轴12的远端部13可以具有预形成的形状，该形状适配为助于相邻目标组织定位远端消融尖头电极24和/或微电极组件26。作为实例，轴12的远端部13的预形成的形状可以是辐射形(例如整体圆形或者整体半圆形)和/或可以定向在横向于轴12的总体纵向方向的平面中。
在一些实例中，系统10可用于患者上的消融程序。作为实例，轴12可以配置为引导进入或者经过患者的脉管系统和/或进入或经过任意其他内腔或腔体。在一个实例中，轴12可以经过患者的脉管系统插入并且进入患者心脏的一个或多个腔室(例如目标区域)。当在患者的脉管系统或心脏中时，轴12可用于使用环形电极22、微电极组件26和/或远端消融尖头电极24来标测和/或消融心肌组织。在一些实例中，远端消融尖头电极24可以被配置为应用消融能量到患者心脏的心肌组织。
在一些实例中，微电极组件26可以围绕远端消融尖头电极24圆周分布。在一些实例中，系统10可以不包括远端消融尖头电极24，并且在该实施例中，微电极组件26可以围绕轴12(例如沿轴12的远端尖头)圆周分布。通常，微电极组件26如它们的名称所暗示的是相对小尺寸的(例如小于远端消融尖头电极24)。微电极组件26可能能够操作或者配置为操作在单极性感测模式或双极性感测模式。在一些情况中，微电极组件26可以限定和/或至少部分地形成一个或多个双极性微电极对。在一个说明性实例中，轴12可以具有围绕远端消融尖头电极24的圆周分布的三个微电极组件26，使得圆周间隔的微电极可以形成各自的双极性微电极对。每个双极性微电极对可能能够生成或者可以配置为生成与靠近其的心肌组织的感测到的电活动(例如电图(EGM)读数)相对应的输出信号。除了圆周间隔的微电极组件26之外，轴12可以另外或可替换地包括一个或多个前向微电极组件26(未显示)。前向微电极组件26通常可以集中定位在远端消融尖头电极24中和/或轴12的尖头的末端处。
在一些实例中，微电极组件26可以可操作地耦接到处理器16，并且从微电极组件26生成的输出信号可以发送到消融系统10的处理器16以用于以本文讨论的一个或多个方式进行处理和/或以其他方式进行处理。作为实例，EGM读数或者来自双极性微电极对的输出信号的信号可以至少部分地形成下文讨论的接触估计、消融区域估计(例如组织生存能力估计)和/或消融过程估计(例如损害形成/化脓分析)的基础。
远端消融尖头电极24可以具有合适的长度并且可以具有合适数量个定位在其中并且关于远端消融尖头电极24圆周地和/或纵向地间隔的微电极组件26。在一些实例中，远端消融尖头电极24可以具有一(1)mm到二十(20)mm之间、三(3)mm到十七(17)mm之间或六(6)mm到十四(14)mm之间的长度。在一个说明性实例中，远端消融尖头电极24可以具有大约八(8)mm的轴向长度。远端消融尖头电极24可以由铂和/或其他合适的材料形成或者否则包括铂和/或其他合适的材料。这些仅仅是实例。
处理器16可能能够处理或者可能配置为处理来自微电极组件26和/或环形电极22的输出信号的电信号。至少部分地基于来自微电极组件26和/或环形电极22的已处理输出信号，处理器16可以生成到显示器(未显示)的输出以被医生或其他用户使用。在生成到显示器的输出的实例和/或其他实例中，处理器16可以可操作地耦接到显示器或者否则与显示器通信。作为实例，显示器可以包括与系统10的使用有关的各种静态和/或动态信息。在一个实例中，显示器可以包括目标区域的图像、轴12的图像和与EGM有关的信息中的一个或多个，其可以被用户和/或系统10的处理器分析以确定心律不齐基质(substrate)在心脏内的存在和/或位置、确定轴12在心脏内的位置和/或做出与轴12和/或其他细长构件的使用有关的其他确定。
系统10可以包括与处理器16通信的指示器。指示器可能能够提供与从轴12的一个或多个电极接收到的输出信号的特征有关的指示。在指示器的一个实例中，可以在显示器上提供与轴12和/或交互的和/或标测的心肌组织的特征有关的指示到医生。在一些情况中，指示器可以提供可视的和/或可听的指示以提供与轴12和/或交互的和/或标测的心肌组织的特征有关的信息。
图2示出了与本文公开的其他系统在形式和功能上类似的另一个示例性系统110。系统110可以包括导管轴112。远端消融尖头电极124可以设置在导管轴112的远端。远端消融尖头电极124可以包括一个或多个灌注端口。远端消融尖头电极124可以例如包括一个或多个圆周灌注端口126。在这些实例中的一些中以及在其他实例中，远端消融尖头电极124还可以包括远端灌注端口128。在不希望/需要灌注的使用中，可以省略或利用环氧树脂密封端口126/128。
在一些实例中，一个或多个微电极组件(例如类似于微电极组件26)可以沿远端消融尖头电极124设置。在这些实例中的一些中以及在其他实例中，电极组件130可以耦接到远端消融尖头电极124。电极组件130可以包括一个或多个电极或者电极区域132。电极组件130可以包括单极性电极、一对或多对双极性电极或其组合。电极132也可以采取传感器如阻抗和/或接触式传感器的形式。近端连接器134可以沿导管轴112设置(例如在其中)。近端连接器134可用于将电极组件130与合适的处理器/生成器连接。
可能由于多个原因希望使用电极组件130。例如，电极组件130可以允许电极132设置在远端消融尖头124的前表面或者远端。这可以允许电极132用于感测远端消融尖头124与目标组织之间的接触。另外，因为其可能具有相对小的、紧凑的形状，所以电极组件130的使用可以沿远端消融尖头124和/或在远端消融尖头124中释放额外的空间用于其他有用的结构如微电极、力传感器、接触传感器、磁传感器等等。此外，电极组件130可以以这样一种方式沿远端消融尖头124缠绕或者否则设置即该方式减少可能钩在组织或其他医疗设备等等上的突出边缘。此外，通过迂回电极组件130经过远端消融尖头124中的开口，可以降低或最小化RF边缘效应。
电极组件130可以具有柔性电路的形式。电极组件130可以例如包括这样一种基板即在该基板上设置有一个或多个电极(例如电极132)。该基板可以包括聚合体材料(例如聚酰亚胺或者其他合适的材料，包括本文公开的那些材料)。电极组件130可以包括涂层如聚对二甲苯涂层或者其他合适的生物兼容涂层。电极132可以利用氧化铱喷溅在基板上。在这些实例中的一些中以及在其他实例中，电极132可以是沿基板设置的铜或金的电极(或者由其他合适的材料制造成的电极)。在一些实例中，可以沿基板设置温度或其他传感器。另外，磁感测线圈、压电薄膜、MEMS力传感器等等可以耦接到组件130。可以适于用作电极组件130的一些示例性柔性电路可以包括或者类似于美国专利申请公开号US 2013/0165926中公开的那些，通过引用的方式将其整体并入本文。为了允许以相对大的体积进行批处理，柔性电路的使用可能是希望的，从而可以增加系统110的可制造性。
在一些实例中，电极组件130可以包括内绝缘层，其接触远端消融尖头124并且将电极组件130与远端消融尖头124电绝缘。电极132可以设置在绝缘层上。可替换地，电极132可以采取导电层或者沿绝缘层设置的轨迹的形式。导电层可以实质上沿绝缘层的整个长度或者沿其一个或多个离散的片段延伸。设想了多种配置。
图3是电极组件130的透视图。这里可以看出电极组件130可以包括多个臂部，包括臂部136a/136b/136c/136d，其中每个臂部具有一个或多个电极132a/132b/132c/132d。每个臂部136a/136b/136c/136d可以包括机械互连构件138a/138b/138c/138d。机械互连构件138a/138b/138c/138d可以用于将电极组件130固定到系统110(和/或远端消融尖头124)。在该实例中，机械互连构件138a/138b/138c/138d采取具有圆锥形边缘的箭头形凸起的形式。该形状可以允许机械互连构件138a/138b/138c/138d穿过开口并且通过干扰而充分俘获在开口中。机械互连构件138a/138b/138c/138d的确切的形状可以变化并且不意图限于仅仅箭头形。机械互连构件138a/138b/138c/138d可以具有各种形状，包括圆形、几何形、具有浮雕挖剪的形状(例如“裂口箭头”形)、具有凸缘和/或凸起的形状、可变形或重塑性成两个或更多个形状的形状等等。这些仅仅是实例。设想了其他形状。
图4-图6示出了用于制造和/或装配系统110的示例性方法。例如，在图4中可以看出电极组件130可以沿远端消融尖头124的内部设置。臂部136a/136b/136c/136d可以定向为使得机械互连构件138a/138b/138c/138d延伸经过远端灌注端口128。可以操作臂部136a/136b/136c/136d使得机械互连构件138a/138b/138c/138d靠近朝向开口140a/140b折叠，如图5中所示。开口140a/140b可以是以合适的方式(例如具有斜面的激光切割，以减少/最小化与组件130的磨损)形成的切口或凹槽。可以理解在图4-图6的视图中仅显示了两个开口140a/140b。然而，在实施中，可以利用合适数量的开口。例如，当电极组件130包括四个臂部时可以利用四个开口。如图6中所示，机械互连构件138a/138b/138c/138d可以延伸进入开口140a/140b(以及在该视图中未显示的类似开口)。这可以将电极组件130固定到系统110(和/或远端消融尖头124)。
近端连接器134可以利用飞线、带状光缆或者通过简单地延伸近端连接器134到处理器/生成器而耦接到合适的处理器/生成器。当将近端连接器134连接到另一个合适的设备或引线时，终端可以沿近端连接器134设置。终端可以通过引线键合、热压焊接、各向异性导电薄膜、焊接等等形成。
图7示出了另一个示例性电极组件230，其可以在形式和功能上类似于本文公开的其他组件，并且可以在适当时与本文公开的系统一起使用。组件230可以包括臂部236a/236b/236c/236d。每个臂部236a/236b/236c/236d可以包括机械互连构件138a/138b/138c/138d。在该实例中，沿每个臂部236a/236b/236c/236d设置两个电极。例如，臂部236a可以包括电极232a/232a’，臂部236b可以包括电极232b/232b’，臂部236c可以包括电极232c/232c’，臂部236d可以包括电极232d/232d’。
图8示出了系统210。系统210包括导管轴212。近端连接器234可以沿轴212设置并且可以耦接到电极组件230。电极组件230可以按照与本文公开的方式类似的方式装配到远端消融尖头224上。例如，臂部236a/236b/236c/236d可以穿过端口228并且迂回进出沿远端消融尖头224的一对开口，使得电极232a/232a’/232b/232b’/232c/232c’/232d/232d’沿尖头224设置。可替换地，每个臂部236a/236b/236c/236d可以沿远端消融尖头224的外表面穿过端口228，并且随后沿远端消融尖头224经过单个开口。在至少一些实例中，远端消融尖头224采取远端消融尖头电极224的形式。
图9示出了另一个示例性电极组件330，其可以在形式和功能上类似于本文公开的其他组件，并且可以在适当时与本文公开的系统一起使用。在该实施例中，电极组件330可以包括三个臂部。例如，组件330可以包括臂部336b/336c以及第三臂部/连接器334。每个臂部336b/336c可以包括机械互连构件338b/338c。每个臂部336b/336c可以包括电极332b/332c。连接器334也可包括电极332a。
图10示出了系统310。系统310包括导管轴312。电极组件330可以按照与本文公开的方式类似的方式装配到远端消融尖头324上。例如，每个臂部336b/236c和连接器334可以穿过端口328并且穿过沿远端消融尖头324的开口，使得电极332a/332b/332c沿尖头324设置。连接器334可以继续沿轴312的内表面(或外表面)到其可以耦接到合适的处理器/生成器的位置。在至少一些实例中，远端消融尖头324采取远端消融尖头电极324的形式。
图11示出了另一个示例性电极组件430，其可以在形式和功能上类似于本文公开的其他组件，并且可以在适当时与本文公开的系统一起使用。组件430可以包括多个电极432。组件430还可以包括开口442和近端连接器434。
图12示出了系统410。系统410包括导管轴412。每个组件430可以按照与本文公开的方式类似的方式装配到远端消融尖头424上。例如，电极组件430可以采取设计为围绕远端消融尖头424圆周延伸的条带的形式。近端连接器434可以延伸通过开口442且然后靠近沿着轴412延伸。这可以包括沿轴412的外表面、沿轴412的内表面或者二者延伸近端连接器434。在至少一些实例中，远端消融尖头424采取远端消融尖头电极424的形式。
图13示出了另一个示例性电极组件530，其可以在形式和功能上类似于本文公开的其他组件，并且可以在适当时与本文公开的系统一起使用。组件530可以包括多个电极532。组件530还可以包括多个机械互连构件538。在该实例中，一对相对的机械互连构件538定位在每个电极532的相对的侧面。组件530还可以包括近端连接器534。
图14示出了系统510。系统510包括导管轴512。每个组件530可以按照与本文公开的方式类似的方式装配到远端消融尖头524上。例如，电极组件530可以围绕远端消融尖头524设置。机械互连构件538可以延伸经过远端消融尖头524中的开口以将电极组件530固定到系统(和/或远端消融尖头524)。在至少一些实例中，远端消融尖头524采取远端消融尖头电极524的形式。
图15示出了另一个示例性电极组件630，其可以在形式和功能上类似于本文公开的其他组件，并且可以在适当时与本文公开的系统一起使用。组件630可以包括臂部636a/636b/636c/636d和近端连接器634。每个臂部636a/636b/636c/636d可以包括一个或多个电极，如电极632a/632b/632c/632d。组件630可以卷进圆柱形配置，如图16中所示。
图17示出了系统610。系统610包括导管轴612。每个组件630可以按照与本文公开的方式类似的方式沿远端消融尖头624装配。例如，电极组件630可以设置在远端消融尖头624中。当装配时，臂部636a/636b/636c/636d延伸经过远端消融尖头624中的开口并且向外径向弓形弯曲。这可能是由于在装配过程期间在电极组件630上应用的压缩力。可替换地，弹性垫圈可以设置在电极组件630中，以便向外径向偏置臂部236a/236b/236c/236d和/或密封沿远端消融尖头624的开口。垫圈的使用可以允许密封远端消融尖头624中的开口而无需使用粘合剂。另外，垫圈的使用还可以允许沿远端消融尖头624的内部设置附加的结构。在一些实例中，组件630的近端和/或远端可以固定到远端消融尖头624的内表面。虽然没有明确显示，但是系统610可以例如沿远端消融尖头624包括一个或多个灌注端口。在至少一些实例中，远端消融尖头624采取远端消融尖头电极624的形式。
可能由于多个原因希望使用电极组件630。使用电极组件630可以例如允许在将损坏喷溅在电极上的氧化铱和/或聚对二甲苯涂层的可能性减小/最小化的同时(例如当电极组件630包括该结构时)装配系统610。还可以减少沿系统610的外表面暴露的电极组件630的长度，这可以减小电极组件630在操作期间俘获的可能性并且还可以减小沿远端消融尖头624可以覆盖的表面积的数量。
虽然图14-图16示出了以轴向定向的臂部636a/636b/636c/636d，但是电极组件630还可以设置为使得臂部636a/636b/636c/636d圆周地或者否则在实质上横向于电极组件630的纵轴的方向延伸。
图18示出了另一个示例性电极组件730，其可以在形式和功能上类似于本文公开的其他组件，并且可以在适当时与本文公开的系统一起使用。组件730可以包括臂部736a/736b/736c/736d。每个臂部736a/736b/736c/736d可以包括一个或多个电极如电极732a/732b/732c/732d和机械互连构件738a/738b/738c/738d。组件730还可以包括一对近端连接器734a/734b。组件730可以被形成为整体圆柱形配置，如图19中所示。
图20示出了系统710。系统710包括导管轴712。每个组件730可以按照与本文公开的方式类似的方式沿远端消融尖头724装配。例如，机械互连构件738a/738b/738c/738d可以延伸经过远端消融尖头724中的开口，以将组件730固定到系统710(和/或远端消融尖头724)。在至少一些实例中，远端消融尖头724采取远端消融尖头电极724的形式。
图21示出了另一个示例性电极组件830，其可以在形式和功能上类似于本文公开的其他组件，并且可以在适当时与本文公开的系统一起使用。组件830可以包括臂部836、机械互连构件838和近端连接器834。图22示出了系统810。系统810包括导管轴812。电极组件830可以按照与本文公开的方式类似的方式沿远端消融尖头824组装。例如，电极组件830可以围绕远端消融尖头424圆周地缠绕。可替换地，电极组件830可以迂回进出远端消融尖头824中的开口。在至少一些实例中，远端消融尖头824采取远端消融尖头电极824的形式。
图23示出了另一个示例性电极组件930，其可以在形式和功能上类似于本文公开的其他组件，并且可以在适当时与本文公开的系统一起使用。组件930可以包括臂部936a/936b/936c/936d。每个臂部936a/936b/936c/936d可以包括一个或多个电极如电极932a/932b/932c/932d和机械互连构件938a/938b/938c/938d。组件930还可以包括近端连接器934。
图24示出了系统910。系统910包括导管轴912。每个组件930可以按照与本文公开的方式类似的方式沿远端消融尖头924装配。例如机械互连构件938a/938b/938c/938d可以延伸经过远端消融尖头924中的开口，以将组件930固定到系统910(和/或远端消融尖头924)。在至少一些实例中，远端消融尖头924采取远端消融尖头电极924的形式。
图25示出了另一个示例性电极组件1030，其可以在形式和功能上类似于本文公开的其他组件，并且可以在适当时与本文公开的系统一起使用。组件1030可以包括设置在圆筒方向中的臂部1036。多个电极1032可以沿臂部1036设置。机械互连构件1038可以设置在臂部1036的末端区域上。组件1030还可以包括近端连接器1034。
图26示出了系统1010。系统1010包括导管轴1012。电极组件1030可以按照与本文公开的方式类似的方式沿远端消融尖头1024装配。例如机械互连构件1038可以延伸经过远端消融尖头1024中的开口，以将组件1030固定到系统1010(和/或远端消融尖头1024)。在至少一些实例中，远端消融尖头1024采取远端消融尖头电极1024的形式。
图27是可以在形式和功能上类似于本文公开的其他系统的另一个示例性系统1110的侧视图。系统1110包括轴1112。一个或多个环形电极1122可以沿轴1112设置。远端消融尖头1124可以设置在轴1112的远端。电极组件1130可以沿远端消融尖头1124设置。电极组件1130可以例如使用粘合剂或者其他合适的附接机制附接到远端消融尖头1124。在一些实例中，单个电极组件1130可以沿远端消融尖头1124设置。在其他实施例中，多个电极组件1130(例如2-8或更多个)可以沿远端消融尖头1124设置。在至少一些实例中，远端消融尖头1124采取远端消融尖头电极1124的形式。每个电极组件1130可以由沿远端消融尖头1124设置的电介质材料形成，电极材料带(例如300串不锈钢、金、铂、铜等等)沿电介质材料设置。电极组件1130可以具有大约0.01-0.04英寸(例如大约0.025英寸)的宽度和大约1-5毫米(例如3毫米或大约0.118英寸)的长度。这些仅仅是实例。
图28是系统1100的一部分的横截面视图。这里可以看出电极组件1130可以包括内绝缘层1150和外导电层或电极区域1132。在这些实施例的一些中或者在其他实施例中，电极组件1130可以包括如本文公开的柔性电路。
虽然图28显示了四个电极组件1130可以围绕系统1110设置，但是这不是为了限制。例如，图29示出了包括沿远端消融尖头1224设置的三个电极组件1230的系统1220。在至少一些实例中，远端消融尖头1224采取远端消融尖头电极1224的形式。类似于电极组件1130，电极组件1230可以包括内绝缘层1250和外导电层或电极区域1232。
图30是可以在形式和功能上类似于本文公开的其他系统的另一个示例性系统1310的侧视图。系统1310包括轴1312。一个或多个环形电极1322可以沿轴1312设置。远端消融尖头1324可以设置在轴1312的远端。电极组件1330可以沿远端消融尖头1324设置。电极组件1330可以包括绝缘层1350和电极区域1332。在该实例中，电极区域1332可以采取由绝缘层1350围绕的离散电极的形式。在至少一些实例中，远端消融尖头1324采取远端消融尖头电极1324的形式。
图31是可以在形式和功能上类似于本文公开的其他系统的另一个示例性系统1410的侧视图。系统1410包括轴1412。一个或多个环形电极1422可以沿轴1412设置。远端消融尖头1424可以设置在轴1412的远端。电极组件1430可以沿远端消融尖头1424设置。电极组件1430可以包括绝缘层1450和多个电极区域1432a/1432b。在至少一些实例中，电极区域1432a/1432b可以是一对双极性电极。在至少一些实例中，远端消融尖头1424采取远端消融尖头电极1424的形式。
图32-图33示出可以在形式和功能上类似于本文公开的其他系统的另一个示例性系统1510。系统1510包括轴1512。一个或多个环形电极1522可以沿轴1512设置。远端消融尖头1524可以设置在轴1512的远端。在至少一些实例中，远端消融尖头1524采取远端消融尖头电极1524的形式。
电极组件1530可以沿远端消融尖头1524设置。在该实例中，如从作为系统1510的端视图的图33中可以看出，电极组件1530可以延伸到远端消融尖头1524的远端和/或者沿远端消融尖头1524的远端延伸。这里可以看出，电极组件1530可以包括绝缘层1550和电极区域1532。
图34是可以在形式和功能上类似于本文公开的其他系统的另一个示例性系统1610的侧视图。系统1610包括轴1612。一个或多个环形电极1622可以沿轴1612设置。远端消融尖头1624可以设置在轴1612的远端。在至少一些实例中，远端消融尖头1624采取远端消融尖头电极1624的形式。
电极组件1630可以沿远端消融尖头1624设置。电极组件1630可以包括绝缘层1650和电极区域1632。
图35是可以在形式和功能上类似于本文公开的其他系统的另一个示例性系统1710的端视图。系统1710包括远端消融尖头1724。电极组件1730可以沿远端消融尖头1724设置。电极组件1730可以包括绝缘层1750和电极区域1732。在至少一些实例中，远端消融尖头1724采取远端消融尖头电极1724的形式。
图36是可以在形式和功能上类似于本文公开的其他系统的另一个示例性系统1810的侧视图。系统1810包括轴1812。一个或多个环形电极1822可以沿轴1812设置。远端消融尖头1824可以设置在轴1812的远端。在至少一些实例中，远端消融尖头1824采取远端消融尖头电极1824的形式。
电极组件1830可以沿远端消融尖头1824设置。电极组件1830可以包括多个绝缘层1850和设置在绝缘层1850之间的电极区域1832。
图37是可以在形式和功能上类似于本文公开的其他系统的另一个示例性系统1910的侧视图。系统1910包括轴1912。一个或多个环形电极1922可以沿轴1912设置。远端消融尖头1924可以设置在轴1912的远端。在至少一些实例中，远端消融尖头1924采取远端消融尖头电极1924的形式。
电极组件1930可以沿远端消融尖头1924设置。电极组件1930可以包括多个绝缘层1950和设置在绝缘层1950之间的多个电极区域1932a/1932b。
可用于系统10和/或本文公开的其他系统的各种组件(例如轴、微电极、远端消融尖头电极、柔性电路、基板等等)的材料可以包括金属、合金、聚合体、金属聚合体合成物、陶瓷及其组合等等或者其他合适的材料。合适的聚合体的一些实例可以包括聚四氟乙烯(PTPE)、乙烯基四氟乙烯(ETFE)、氟化乙烯丙烯(FEP)、聚甲醛(POM例如从杜邦可得的)、聚醚酯、聚亚安酯(例如聚亚安酯85A)、聚丙烯(PP)、聚氯乙烯(PVC)、聚醚酯(例如从DSM工程塑料可得的)、基于共聚物的天空醚或酯(例如，丁烯/聚(亚烷基醚)的邻苯二甲酸和/或其他聚酯弹性体如从杜邦可获得的)、聚酰胺(例如，可从拜耳获得的或可从ELF Atochem获得的)、弹性聚酰胺、嵌段聚酰胺/醚，聚醚嵌段酰胺(PEBA，例如可从商标名获得)、乙烯-醋酸乙烯酯共聚物(EVA)、硅树脂、聚乙烯(PE)、聚丙烯高密度聚乙烯、聚丙烯低密度聚乙烯、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、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(如可从EMS美国Grilon获得的)、全氟(丙基乙烯基醚)(PFA)，乙烯-乙烯醇共聚物、聚烯烃、聚苯乙烯、环氧树脂、聚偏氯乙烯(PVdC)，聚(苯乙烯-b-异丁烯-b-苯乙烯)(例如，SIBS和/或SIBS 50A)，聚碳酸酯，离聚体，生物相容性的聚合物，其他合适的材料，或混合物，组合，其共聚物、聚合物/金属复合材料等。
合适金属和金属合金的一些实例包括不锈钢，如304V、304L、和316LV不锈钢；碳钢；镍钛合金如线性弹性和/或超弹性镍钛合金；其他镍合金如镍-铬-钼合金(UNS:N06625例如：如625、UNS：如C-UNS:N10276如其他合金等)、铜镍合金(UNS：N04400例如：400、400、400等)，镍钴铬钼合金(例如，UNS:R30035如MP35等)，镍钼合金(例如，UNS:N10665如ALLOY)，其他镍铬合金，其他镍钼合金，其他镍钴合金等，其他的铁镍合金、镍铜合金等，其他镍钨或钨合金，等；钴铬合金；钴铬钼合金(例如，UNS:R30003如 等等)；铂丰富不锈钢；钛；及其组合等；或任何其它合适的材料。
如本文提到的，在商业上可用的镍钛或镍钛合金族是标明“线性弹性”或“非超弹性”的一类，其虽然可能在化学性上与常规形状记忆和超弹性品种是类似的，但是可以表现出不同并且有用的机械属性。线性弹性和/或非超弹性镍钛合金与超弹性镍钛记忆合金区别在于：线性弹性和/或非超弹性镍钛合金不会像超弹性镍钛记忆合金一样在应力/应变曲线中显示实质性的“超弹性稳态”或“标志区域”。相反，在线性弹性和/或非超弹性镍钛合金中，随着张力的增加，应力继续实质上线性增加，或有点但无需完全的线性关系，直到塑性变形开始或至少在处于这样一种关系中即该关系比超弹性镍钛记忆合金可见的超弹性稳态和/或标志区域更加线性。因此，为了本公开的目的，线性弹性和/或非超弹性镍钛合金也被称为“实质上”线性弹性和/或非超弹性镍钛记忆合金。
在某些情况下，线性弹性和/或非超弹性镍钛记忆合金与超弹性镍钛记忆合金区别还可以在于线性弹性和/或非超弹性镍钛记忆合金可以接受高达约2-5％的应力同时保持实质上弹性(例如，在塑性变形之前)而超弹性镍钛记忆合金在塑性变形前可以接受高达8％左右的应力。这两种材料可区别于其他线性弹性材料如不锈钢(也可根据其成分区分)，其在塑性变形可能只接受0.2到0.44％应力。
在一些实施例中，线性弹性和/或非超弹性镍钛合金是在一个大的温度范围不显示通过差示扫描量热法(DSC)和动态金属热分析(DMTA)分析可检测的任何马氏体/奥氏体相变的合金。例如，在一些实施例中，在线性弹性和/或非超弹性镍钛合金可能在约–60摄氏度(℃)到约120℃的范围没有通过DSC和DMTA分析可检测的马氏体/奥氏体相变。因此，这样材料的机械弯曲性能一般在这个非常宽的温度范围内不易受温度的影响。在一些实施例中，线性弹性和/或非超弹性镍钛合金的该机械弯曲性能在环境温度或室温下实质上与在体温下的机械性能相同，例如，因为它们不显示超弹性稳态和/或标志区。换句话说，在宽的温度范围内，线性弹性和/或非超弹性镍钛合金保持其线性弹性和/或非超弹性特性和/或性能。
在一些实施例中，线性弹性和/或非超弹性镍钛合金的镍的重量可在约50％至约60％范围内，其余的基本上是钛。在一些实施例中，组合物的镍重量在约54％至约57％的范围内。合适的镍钛合金的一个例子是从日本神奈川古河电子材料有限公司商业可得的FHP-NT合金。通过引用并入本文的美国专利号5,238,004和6,508,803披露了一些镍钛合金的例。其他合适的材料可能包括ULTANIUMTM(从Neo-Metrics可得)和GUM METALTM(从丰田可得)。在一些其它实施例中，一种超弹性合金，例如超弹性镍钛合金可用于实现所需的性能。
至少在一些实施例中，系统10的组成也可掺入不透射线的材料，由不透射线的材料制造或者否则包括不透射线的材料。不透射线的材料应理解为在医疗手术期间能够在荧光屏或其他成像技术产生一个较亮的图像的材料。这种相对明亮的图像帮助系统10的用户确定其位置。一些不透射线的材料的例子包括，但不限于，金、铂、钯、钽、钨合金、具有不透射线的材料填充物的聚合物材料等。此外，其他标记物带和/或线圈也可以被并入10系统的设计来达到同样结果。
在一些实施例中，将磁共振成像(MRI)兼容性的程度引入到系统10中。例如，系统10的组成或其部分可以由不实质扭曲图像并产生实质性的人造物(例如，图像中的间隙)的材料制成。例如，某些铁磁材料可能不合适，因为它们可能在MRI图像中产生伪影。系统10的组成或其部分也可以由MRI机器可成像的材料制成。表现出这些特点的一些材料包括例如钨、钴铬钼合金(例如UNS:R30003如等)，镍钴铬钼合金(例如UNS:R30035如MP35-等)，镍钛合金等等。
应该理解本公开在许多方面仅是说明性的。可在细节尤其是形状、尺寸和步骤安排方面做出修改而不会超出本公开的范围。这可包括在适当的程度内一个实施例的特征中的任一个的使用被使用在其他实施例中。当然，本发明的范围是所附要求表述的语言定义的。
可对示例性实施例进行各种修改和补充而不会脱离本发明的范围。例如，虽然上述的实施例涉及特定特征，本发明的范围也包括具有不同特征组合的实施例和不包括所有所描述的特征的实施例。因此，本发明的范围意图包括落入本发明的范围中的所有这些替代物、修改和变化连同其所有等效物。

Claims (15)

1.一种用于心脏标测和/或消融的导管，所述导管包括：
具有远端消融电极区域的细长导管轴；
耦接到所述远端消融电极区域的电极组件；以及
其中，所述电极组件包括柔性电路，所述柔性电路具有设置在其上的一个或多个电极。
2.根据权利要求1所述的导管，其中，所述远端消融电极区域具有形成在其中的开口，以及其中，所述电极组件延伸经过所述开口。
3.根据权利要求1-2中任意一个所述的导管，其中，所述电极组件包括沿所述远端消融电极区域的远端设置的区域。
4.根据权利要求1-3中任意一个所述的导管，其中，所述电极组件包括多个臂部区域，以及其中，所述臂部区域中的每个包括至少一个电极。
5.根据权利要求4所述的导管，其中，所述电极组件包括三个或更多个臂部区域。
6.根据权利要求4所述的导管，其中，所述电极组件包括四个或更多个臂部区域。
7.根据权利要求1-6中任意一个所述的导管，其中，所述电极组件包括能够将所述电极组件机械地固定到所述远端消融电极区域的机械锁定端区域。
8.根据权利要求7所述的导管，其中，所述远端消融电极区域具有形成在其中的开口，以及其中，所述机械锁定端区域延伸经过所述开口。
9.根据权利要求1-8中任意一个所述的导管，其中，所述导管轴包括内部通道，其中，所述远端消融电极区域包括第一开口和第二开口，以及其中，所述电极组件沿所述内部通道延伸经过所述第一开口，沿所述远端消融电极区域的外表面延伸并且经过所述第二开口。
10.根据权利要求1-9中任意一个所述的导管，其中，所述电极组件粘性结合到所述远端消融电极区域。
11.根据权利要求1-10中任意一个所述的导管，其中，所述电极组件包括一个或多个电极区域以及一个或多个电绝缘区域。
12.根据权利要求1-11中任意一个所述的导管，其中，所述电极组件围绕远端消融电极区域圆周延伸。
13.根据权利要求1-12中任意一个所述的导管，其中，所述电极组件被设计为从所述远端消融电极区域径向地向外弓形弯曲。
14.根据权利要求1-13中任意一个所述的导管，其中，所述远端消融电极区域包括铂消融尖头电极。
15.一种用于制造医疗设备的方法，所述方法包括：
将电极组件插入形成在导管的远端消融尖头内的通道中；
其中，所述电极组件包括柔性电路，所述柔性电路具有设置在其上的一个或多个电极；
其中，所述远端消融尖头包括第一开口和第二开口；以及
延伸所述电极组件经过所述第一开口，沿所述远端消融尖头的外表面延伸并且经过第二开口。
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