CN110141177B - 消融导管 - Google Patents

消融导管 Download PDF

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Publication number
CN110141177B
CN110141177B CN201910375130.6A CN201910375130A CN110141177B CN 110141177 B CN110141177 B CN 110141177B CN 201910375130 A CN201910375130 A CN 201910375130A CN 110141177 B CN110141177 B CN 110141177B
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China
Prior art keywords
ablation
electrode
electrodes
balloon
catheter
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CN201910375130.6A
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CN110141177A (zh
Inventor
A·萨拉希
J·莱帕克
E·梁
B·D·布兰特
J·P·克劳德
C·阿金托
T·苏玛纳维拉
Z·维斯特
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Boston Scientific Scimed Inc
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Apama Medical Inc
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Abstract

心脏消融导管和使用方法，在一些实施方案中，该导管包括在可膨胀膜内部用于对消融术可视化的至少一个摄像机。

Description

消融导管
本申请是申请号为201480029141.4，申请日为2014年4月8日，发明名称为“心脏消 融导管及其使用方法”的分案申请。
相关申请的交叉引用
本申请是2011年5月12日提交的美国申请号13/106658的部分继续申请，其是2009年11月11日提交的美国专利号12/616758的部分继续申请，现在为美国专利号8295902，这两者都通过引用并入本文。美国申请号13/106658还要求以下美国临时申请的优先权：2010年5月12号提交的申请号61/334154；2008 年11月11日提交的申请号61/113228；2009年3月13日提交的申请号61/160204； 2009年5月19日提交的申请号61/179654；2009年8月10日提交的申请号 61/232756；2009年10月21日提交的申请号61/253683，所有上述的公开内容通过引用并入本文。
本申请还要求以下14个美国临时申请的权益，其公开内容通过引用并入本文：2013年4月8日提交的申请号61/809629；2013年4月8日提交的申请号 61/809646；2013年10月25日提交的申请号61/895880；2013年4月8日提交的申请号61/809636；2013年8月9日提交的申请号61/864335；2013年5月31 日提交的申请号61/829985；2013年5月8日提交的申请号61/820992；2013年 5月8日提交的申请号61/821001；2013年5月8日提交的申请号61/821014； 2014年1月31日提交的申请号61/934640；2014年2月12日提交的申请号 61/939185；2014年1月31日提交的申请号61/934647；2014年2月26日提交的申请号61/945005；和2014年3月4日提交的申请号61/947950，所有上述的公开内容都通过引用并入本文。
通过引用并入
本说明书中提到的所有出版物和专利申请在此通过引用并入本文，如同每个单独的出版物或专利申请具体地和单独地被指示为通过引用并入的相同程度。
背景技术
能量传输到组织可用于治疗各种医学状况。电极可用于将能量递送到组织和细胞用于感测、映射、消融(ablate)和/或刺激肌肉和/或神经的目的。肌肉和/ 或神经的刺激可被用来触发信号到大脑或直接到指定的肌肉细胞/组。当治疗需要除去或破坏目标组织时，热消融治疗可用于利用外科器械(诸如耦合至加热探针针尖、目标组织或两者的能量源的针或探针电极)来加热目标组织。在这种情况下，热能可以通过加热或冷却探针直接递送、或通过在组织内生成能量场从而生成热量来间接递送、或两者。通常用来间接产生热的能量场是RF和声能场。大多数消融术(ablation procedure)的目标是实现细胞迅速精确地死亡，并且具有最小附带损伤至没有附带损伤。
在热消融疗法用于终止破坏性心脏传导通路的情况下，能量可以使用微创技术(诸如电极尖端导管)被递送到异常细胞。经由射频导管消融的肺静脉隔离已经被证明是对经历心房颤动(AF)的一些患者的有效治疗。AF消融术的基础是相对大的肺静脉室的电隔离。用老一代AF消融设备消融大汇合区域或消融线是通过点到点操作完成，并且通过单电极尖端完成RF应用。单电极导管技术非常耗时、复杂且充满主观性。此外，目标组织中电活动的有效和完整映射常常需要在左心房中放置多个导管，使用三维映射和/或转向系统。通常希望创建具有相对浅的消融深度的相对较大的表面积病灶。
用于“一次使用(oneshot)”消融的较新的大电极阵列已经用于改进导管消融治疗。这些消融系统已经被采纳，以此来提供全面接触具有复杂的三维解剖结构和整体较大的病灶面积的组织。但已知的设备包括体积大、刚性并且在有效地填充以及高效地进入治疗导管的小空间中的能力有限的电极。这些设备的刚度限制了针对组织的适应性，导致需要额外的重新定位和重叠模式来确保消融线不间断。
发明内容
本公开的一个方面是一种消融导管，其包括：可膨胀膜和固定到所述可膨胀膜的外部的多个消融电极；设置在可膨胀膜内的成像构件；固定到可膨胀膜的至少近端部分的漫反射器；以及设置在可膨胀构件内并且被定位成引导光朝向漫反射器的光源，使得光的漫反射被引导朝向成像构件的视场。
在一些实施方案中，成像构件通常远侧地面向并且光源通常近侧地面向。成像构件和光源可以固定到内部导管轴。成像构件可以是取向以提供围绕导管的纵轴360度视野的多个摄像机。成像构件可以相对光源远侧地设置。
在一些实施方案中，漫反射器不会延伸到可膨胀膜为膨胀构型时的远端。漫反射器可以延伸不超过沿可膨胀膜为膨胀构型时的远端长度的约一半长度。
在一些实施方案中，漫反射器包括由固定到可膨胀膜的外部的柔性电路划分的第一部分和第二部分，所述柔性电路包括与多个电极中的至少一个电连通的至少一个导电层。
本公开的一个方面是适于定位在患者体内的可充气组件，其包括：可膨胀膜；设置在可膨胀膜内的成像构件；固定到可膨胀膜的至少近端部分的漫反射器；以及设置在可膨胀构件内并且被定位成引导光朝向漫反射器的光源，使得光的漫反射被引导朝向成像构件的视场。
本公开的一个方面是一种消融导管，包括：可膨胀膜和固定到所述可膨胀膜的外部的至少一个消融电极；设置在可膨胀膜内的成像构件，所述成像构件具有视场；设置在可膨胀构件内的光源，其适于将光递送朝向成像构件的视场；以及反射调节器，其适于减少光从多个消融电极的至少一个电极镜面反射进入成像构件的视场中。反射调节器可以是光吸收器。反射调节器可适于散射光远离成像构件的视场。反射调节器可以是在以下各项中的至少一项上的抗反射涂层：气囊(balloon)的内部，或该至少一个电极。
本公开的一个方面是一种视频显示方法，包括：接收来自固定到导管的运动中的摄像机的多个图像；计算相对于其位置相对摄像机是固定的特征，图像中所示的解剖特征的质心的平均旋转；以及作为输出图像通信，其中解剖特征是固定的，并且其位置相对摄像机是固定的特征示出为移动的。
本公开的一个方面是稳定心脏组织的图像同时移动定位在心脏内的摄像机的方法，包括：在左心房内提供消融导管，该消融导管包括可膨胀膜，固定到可膨胀膜的外表面的多个电极，定位在该可膨胀膜内的至少一个摄像机，当可膨胀膜为膨胀构型时具有相对于多个电极的位置固定的视场，和光源；以及响应于摄像机在左心房内的运动，并且当摄像机被移动时显示心脏组织的视频，其中心脏组织的位置是固定的，并且所述视场中的多个电极是移动的。
本公开的一个方面是将心脏组织的图像与附加信息叠加的方法，包括：在左心房内定位消融导管，所述消融导管包括可膨胀膜，固定到可膨胀膜的外表面的多个电极，定位在可膨胀膜内的至少一个摄像机，和光源；用至少一个摄像机捕捉图像，其中所述图像示出以下各项中的至少一项：多个电极的至少一个电极，和心脏组织；获得指示以下各项中的至少一项的附加信息：心脏组织的特征，和消融导管的特征；显示示出以下各项中的至少一项的具有叠加在其上的附加信息图像：多个电极的至少一个电极，和心脏组织。
在一些实施方案中，附加信息包括与多个电极中的一个电极相邻的心脏组织的指示符。该附加信息可以包括与多个电极中的一个电极相邻的心脏组织的温度。
在一些实施方案中，附加信息是定性指示符。
在一些实施方案中，附加信息是定量指示符。
在一些实施方案中，附加信息包括多个电极中的至少一个电极的状态，诸如开或关。
本公开的一个方面是一种消融导管，包括：可膨胀膜和固定到所述可膨胀膜的外部的多个消融电极；设置在所述可膨胀膜内的至少一个成像构件，所述至少一个成像构件具有包括多个消融电极的视场；以及与多个电极中的每个电极相关联并适于在视场中视觉地可识别的电极标识符，从而使得多个电极中的每个电极能够视觉上可识别。
在一些实施方案中，电极标识符包括在电极中的每个电极上或附近的字母数字字符。
在一些实施方案中，电极标识符是与电极中的每个电极相关联的颜色。
在一些实施方案中，电极标识符符是电极的形状。
在一些实施方案中，电极标识符是用于多个电极中的至少一个电极的第一类型标识符，和用于多个电极中的至少第二个电极的第二类型标识符。
附图说明
图1A-图1C图示膨胀构型的示例性消融设备。
图1D图示了在收缩构型的示例性消融设备。
图2A是消融导管的示例性远端的侧视图。
图2B是图2A的导管内部的关闭侧视图。
图3是示出可膨胀膜的内部的透视图。
图4图示了摄像机组件。
图5是消融导管的远端的透视图以及可膨胀构件的剖面。
图6是LED柔性电路的示例性平面视图。
图7图示装有包括护套管的可滑动的护套工具的设备的远端。
图8是示出固定到膜的外部和电极的三个单独的柔性电路的平面视图。
图9A图示了图8中柔性电路和电极中的一个的一部分。
图9B图示了从图9A的S-S截面的柔性电路的示例性不同层。
图10图示了三个柔性电路中每个柔性电路尾部，其终止在从气囊的远端向近侧延伸的终端并在外轴内向近侧延伸，并且固定到气囊和冲洗轴(irrigation shaft)的近端外表面上。
图11A-图16图示了适于具有映射结构或适于与映射结构一起使用的示例性消融导管。
图17是示例性的可视化导管的远端部分的侧视图。
图18A-图18D示出了四个摄像机的轴相对于导管轴的纵轴的取向。
图19示出了四个摄像机之一的几何形状，并且所有四个摄像机具有相同的几何形状。
图20示出了通过代表摄像机获得的规则网格图案目标的图片。
图21A-图21C示出了可用于将椭圆气囊的三维表面展开(unwrap)为二维平面的参数化。
图22示出了使用已知的图案模拟一组四个摄像机图像，在这种情况下，消融电极涂在膜上。
图23示出了通过使用上面描述的方法将图22的图像回投到展开的气囊表面而生成的全景图像。
图24中通过将组成图像回投到展开的气囊表面而生成全景图像。
图25示出了使用本文描述的方法由四个摄像机获得的组织图像。
图26A-图26C图示了借助线性地可位移芯提供AC功率从电源转移至加载的转移的连续或半连续调整的机电设备。
图27是图示芯的运动相对于AC输出的大小的图形。
图28A和图28B表示其中芯被微步进马达和螺旋机构替换的一个实施方案。
图29仅图示了摄像机组件中四个摄像机之一的四个视场之一。
图30图示了四个摄像机的四个视场，每个与至少一个其它视场重叠，以为医师提供360度视野。
图31A-图31C图示了消融心脏组织的示例性方法。
图32A-图32C图示了消融心脏组织的示例性方法。
图33是示例性实施方案的电方面的示例性示意图。
图34图示了来自多个信道的映射信号。
图35和36图示了外部控制台(console)的各方面。
图37图示了心脏消融系统的示例性框图。
图38图示了示例性的信息和可以在来自摄像机的图像上叠加的指示符。
图39代表用于应用至气囊的外表面的示例性柔性电路。
图40示出了附接至气囊的组装柔性电路。
图41A和图41B图示了显示器上呈现给用户的如本文所述的来自四个摄像机阵列的复合视图。
图42和图43图示了消融导管的示例性实施方案，其中气囊配置为用于接触(物理)测量。
图44图示了在左心房中的消融气囊和定位并在食道充气的食管温度气囊。
图45图示了包括心内膜导管和心外膜导管的实施方案。
具体实施方式
本公开描述了配置用于诊断、预防和/或治疗心律失常的方法、系统和设备。本公开包括配置用于消融心脏组织的方法和设备。本公开涉及并通过引用并入于2013年10月23日公告的美国专利号8295902和于2012年3月22日公布的美国公开号2012/0071870中描述的设备和方法，其公开内容通过引用并入本文。这里的设备可以包括上述申请的实施方案中的合适的结构特征，即使本公开没有明确包括它们。此外，本文使用的方法可包括上述申请的实施方案中的合适的方法步骤，即使本公开没有明确包括它们。
图1A-图1C图示了示例性心脏消融导管的远端部分。图1A-图1C示出膨胀构型的可膨胀构件10。图1A是远端视图，图1B是透视图，并且图1C是侧视图。
心脏消融导管被配置为将消融能量递送到组织(诸如心脏组织)并消融该组织。可膨胀构件10包括膜或气囊12和固定到膜12的外部的多个能量递送元件14。在此实施方案中，能量递送元件14是被配置并定位以当可膨胀构件10充气时将消融RF能量递送到组织并消融该组织的电极，并与配置成生成RF能量的RF发生器(未示出)电连通。
图1D示出了完全膨胀之前为收缩或放气构型的可膨胀构件10。
图2A是图1A-图1C中所示的消融导管的远端部分的侧剖面图。图2B是外轴51内的组件的突出显示的侧剖视图。图2A示出了在外腔(outer lumen)50 的远端膨胀的膜12，外腔50是外轴51和冲洗轴55之间的环形空间。诸如通过按压配合和/或粘合剂将膜12的远端固定到远侧毂组件(hub assembly)20，如图所示位于组件20的内构件和外构件之间。膜12的近端被固定到冲洗轴55的外表面。毂20被固定到导向线(guide wire)轴54，其在本实施方案中限定导向线腔53，以使消融导管可以前进通过导向线(未示出)。导向线轴54和冲洗轴55适于相对彼此轴向移动，这使得膜12的远端相对于膜12的近端移动。两个组件之间的相对运动可允许气囊的形状改变。该运动还有助于将可膨胀构件10转变为收缩构型，如图1D所示。
可视化系统30包括摄像机组件32和设置在导向线轴54上的照明源35。摄像机被配置为使得能够对可膨胀构件10内的过程进行实时成像，以对膜和电极、在膜/电极和心脏组织进行接口时的心脏组织、以及消融术期间的损伤形成进行可视化，如在下面更详细描述的。
图2B示出了径向外轴51，限定冲洗腔52的冲洗轴55，和限定导向线腔53 的导向线轴54。
本文所描述的膜12的的材料可以变化。通常，该膜的材料是薄的，容易折叠为低轮廓且在膨胀后可重新折叠。该材料可以是弹性的、非弹性的、伸展的、非伸展的、顺从的、半顺从的或非顺从的。在一个实施方案中，膜12具有可膨胀结构并且可由以下材料构成：诸如用于构成本领域中已知的气囊导管的那些材料，包括但不限于聚氯乙烯(PVC)、聚乙烯(PE)、交联聚乙烯、聚烯烃、聚烯烃共聚物(POC)、聚对苯二甲酸乙二醇酯(PET)、尼龙、聚合物共混物、聚酯、聚酰亚胺、聚酰胺、聚氨酯、硅树脂、聚二甲基硅氧烷(PDMS)等。膜12可以由相对非弹性聚合物(诸如PE、POC、PET、聚酰亚胺或尼龙材料)构成。膜12可以由相对顺从的弹性体材料构成，包括但不限于：硅树脂、乳胶、聚氨酯或者聚酯薄膜弹性体。膜12可以嵌入其它材料，诸如例如金属、芳纶或尼龙纤维。膜12可以由薄的不可伸长的聚合物膜构成，诸如聚酯或其它柔性热塑性或热固性聚合物膜。在一个实施方案中，柔性膜12的厚度可为约0.001”至约0.002”，以提供足够的爆裂强度(burst strength)并允许可折叠性。在一些实施方案中，优选具有尽可能接近膜机械性能的电极机械性能。提供这一点的一种方式是使用非弹性膜，当膨胀时其不会伸展。这有助于将分支(branch)固定到膜。膜12具有前端或远端面，其通常是平坦的但也可具有其它形状。
可膨胀构件10包括柔性电路，如通常在2012年10月23日公告的美国专利号8295902和2012年3月22日公布的美国公开号2012/0071870所提及的。本文所用的柔性电路一般指的是导电层、绝缘层和任选的衬底层。柔性电路与至少一个电极电连通。
图8是示出了被固定到膜12的外部的三个单个柔性电路的平面视图。三个单独柔性电路中的每个柔性电路包括六个能量递送元件14，和针对六条导电迹线(trace)的终端41中终止的尾部，一条导电迹线用于六个电极之一。终端可以是连接器或焊盘或其它此类合适的接口的形式。终端41从可膨胀构件上的能量递送元件向近侧延伸，其中之一可以在图1D中看到。每个尾部分叉(branch off) 成三个分支16，每一个都包括两个能量递送元件。两个侧分支16中的每个侧分支以基本上相同的角度延伸远离连接器的纵轴，并且在侧分支上的两个电极中的每个电极被设置为与在另一侧分支上的其它对应电极相同的轴向位置(在远端 /近端方向)。然而，中央分支最初沿与尾部的纵轴大致相同的方向延伸，并且在中央分支上的第一电极轴向地设置为与在右分支和左分支上的第二电极大致相同的位置。中央分支然后延伸远离尾部的纵轴，并且中央分支上的第二(远侧) 电极设置在比柔性电路上的其它五个电极的更远侧，并且设置为与另一侧分支之一上的第一(近侧)电极径向(相对于尾部的纵轴)大致相同的位置。在图8中，柔性电路之一上的六个电极被标记为A-F。柔性电路的两个侧分支分别包括电极 A-B和E-F。中央分支包括电极C和D。在平面视图中，电极C(中央分支的远侧电极)被轴向设置在与电极B和F大致相同的位置。电极D被设置在比其它五个电极的更远侧，并被径向定位在与电极A大致相同的位置。电极A和E被设置在大致相同的轴向位置，电极B、C和F也一样。三个柔性电路中的每个柔性电路被定位在可膨胀构件上，并且电极的布置和大小提供用于固定到可膨胀构件的18个电极。如图1A和图1B中可以看出，存在紧密围绕毂(hub)20的三个电极。
图9A图示图8中的柔性电路中的一个柔性电路(柔性电路，其中终端41处在“6点钟”的位置)的一部分，包括6个能量递送元件14。图9A示出为备选实施方案，其中中央分支16上的远侧电极延伸到页面上的右侧而不是左侧，如图8所示。这种布置提供了气囊上18个电极的相同的一般布置。在图1A-图1C 的实施方案中，图9A中的三个柔性电路设置在膜12上，并且因此18个能量递送元件固定到膜12。图9B示出了从图9A的截面S-S的柔性电路的示例性不同层。电学上非导电衬底层13沉积在膜12上，在其上沉积导电层或迹线15。绝缘层17沉积在导电层15除电极14所处的位置以外的顶部上。例如，在图9B 左侧，电极14设置在导电元件15上，从而电耦合电极14和导电层15，其被电耦合到RF发生器。在图9B的右侧，绝缘层17防止右侧的导体15被电耦合到电极14。相反，右侧的导体15将被电耦合到分支的远侧电极。每个单独的导体 15因此电耦合到仅一个电极14。在图9A中所示的图中，有六条单独的导电迹线15，其中的每一条单独耦合到一个电极。如在2012年10月23日公告的美国专利号8295902和2012年3月22日公布的美国公开号2012/0071870中详细描述的，电极被尺寸化和配置成延伸跨过柔性电路的一部分以及由柔性电路未覆盖的膜的一部分。以这种方式，大表面积电极可沉积到并固定到膜上。每个电极被示出在其中间具有冲洗孔，如本文中所描述以冲洗与电极相邻的组织，并防止膜内部的冲洗液体变得太热，并干扰组织消融。
导体或导电层15可以是以下材料，诸如但不限于：铜、金、银、锡、镍、钢、铜镍(铜镍合金)、KOVAR(镍-钴铁合金)的金属或金属箔或其它材料。在一个实施方案中，一种以上的导电材料可用于导电层15中。在一个实施方案中，铜的导电层15可以在电极14下方的导电焊盘被镀上薄层额外的导电材料。在一个实施方案中，薄层额外的导电材料可以是金。可以使用本领域已知的技术来制造柔性电路及其部件。
用于产生电极14的材料可以变化。电极14可以是导电或光学油墨的薄膜。油墨可以是基于聚合物的用于更好的粘附到膜。该电极材料可以是生物相容的低电阻金属，诸如银、银片、金和铂，并且此外它们不透射线(radiopaque)。油墨可额外包含诸如碳和/或石墨的材料与已经描述的更多导电材料组合。碳和/或石墨的附加可提高聚合物基体的导电性。当作为纤维掺入时，碳和/或石墨为油墨电极增加额外的结构完整性。其它纤维材料可被取代以达到同样的目的。当电极材料不是特别地不透射线时，添加剂(诸如钽和钨)可以与电极材料混合以增强辐射不透性(radiopacity)。导电油墨的示例是由EngineeredConductive Materials 有限责任公司(ECM)提供的基于聚氨酯的银加载油墨。另一个示例是Creative Materials公司，该公司制造导电性油墨、膜以及不透射线的油墨。如上所述，电极14可以被应用到使用粘合剂的膜12和柔性电路。可备选地，电极材料可具有粘合性能或是加载有粘合剂的导电颗粒(诸如银片)，使得电极14能够将柔性电路的组件粘附着到膜12。如果附加的粘合层用于将电极14粘合至膜12和柔性电路，所述粘合剂层可以包括导电材料或非导电材料。在荧光透视 (fluoroscopy)下可以可视化由导电或光学油墨或薄金属膜形成的电极，以提供膜的形状和电极的位置的一般含义。为增强在透视下的可视化，不透射线添加剂可包括布置在电极邻近、上面或下面的电极材料或不透射线标记中，如将在下面更详细地讨论的。另外，结合层或衬底将最佳地由最小反射材料组成。
每个电极是单独可寻址的，或者可以与任何其它电极来一起使用。电极可在单极模式或双极模式下工作，如显示在图34的示例性原理图所示。可以选择电极组使得损伤是例如但不限于线、点或者空心圆。
图3图示膜12的远端和毂20的耦合，其可以是按压配合、粘合剂耦合或两者的组合。
为了防止或减少与能量递送元件接触的组织炭化(charring)和与电极相邻的血液凝血的可能性，在所述电极位置的每个柔性电路包括穿过其中的冲洗孔，并且如所示的是电极的中心。冲洗孔还防止膜内部的充气/冲洗流体变得太热，这会干扰消融。冲洗流体也是对膜12充气使其朝向其膨胀构型重新配置的流体，其从流体源泵出通过冲洗腔52进入膜12，通过冲洗孔(未标记)，并朝向与电极接触的组织，以冷却目标组织。以前在心脏消融的尝试的缺点之一是消融术由于缺乏冷却功能会引起血液凝结或引起组织炭化。此外，由于每个电极是单独可寻址的，因此可视化系统允许操作者识别单独的电极是否与组织相接触，只有与组织接触的电极可以被导通。因此能量更有效地仅耦合到其中期望消融的部位，并且很少至几乎没有能量消散到血液中。
本文中消融导管的显著优点之一是在使用时消融术可以用来自膨胀膜之内的透视用成像或可视化构件来可视化。在图1A-图1D的实施方案中，成像构件 30包括摄像机组件32，其包括多个摄像机33和多个照明或光源35(例如，LED)。可膨胀构件10还包括漫反射器22，其被固定到膜12的外表面。反射器22是适于产生从照明源入射在其上的光的漫反射的漫反射器。反射器22适于以漫反射方式反射光(与镜面反射相反)以更好地照明尽可能多的摄像机视场。如果反射器为适于镜面反射而不是漫反射，则从反射器反射的照明源的光会作为局部点出现在摄像机视场中，而不会照亮尽可能多的视场。
照明源35被配置和定位以提供大致径向向外朝向反射器22的照明。漫反射器22因而漫反射光向前朝向摄像机视场的光。照明源由此为摄像机提供照明以可视化该过程，包括组织和病变的形成。
在一些实施方案中，漫反射器被印在气囊的外部。漫反射器可以由填充有非导电白色颜料(诸如TiO、BaO、BaSO4、苯乙烯或其它聚合物珠)的硅树脂或聚氨酯树脂组成或由金属颗粒组成。最佳的材料将是最低反射的，诸如黑色粘合剂。
在本实施方案中，漫反射器被固定到膜，使得其不完全重叠任何电极，并且被定位使得照明源当被激活时向反射器发射光。在本实施方案中，漫反射器或反射器被固定到不一直延伸到膜的远端的位置处的膜。在本实施方案中，反射器被固定到膜，使得其不会比最近侧电极更向远侧延伸。然而，在备选实施方案中，反射器可以向远侧延伸到膜附近的一些位置中的最近侧电极。例如，反射器的远侧边缘可以是弯曲的而不是直的，并且根据膜上的电极布局，反射器的一些部分可相对于最近侧电极向远侧延伸。如果为膨胀构型该膜可分为限定远侧部分和近侧部分的最远侧位置和最近侧位置之间的两半，该反射器至少设置在在近侧部分上。在图1A-图1C示出的实施方案中，反射器仅设置在近侧部分。
本公开的一个方面是可膨胀构件，其包括漫反射器但不包括任何消融元件。例如，其中包括可膨胀构件和至少一个摄像机以及至少一个光源的医疗设备可以受益于漫反射器，即使该设备不用于消融术。
虽然在本文中反射器被描述为漫反射器，但是可能会有某些用途，其中镜面方式反射光的该反射器可能是有益的。备选地，反射器可以具有以漫射方式反射光的部分和以镜面方式反射光的部分。
图4示出示例性摄像机组件32，其包括四个摄像机33，其以相对于导管纵轴的角度设置在摄像机毂37内。摄像机毂37被固定到导向线轴54，并且包括被配置成在其中接收导向线轴54的内腔39。
图5是具有膜的剖面的可膨胀构件10的另一透视图。图6是LED柔性电路 (包括LED)的示例性平面视图，其缠绕在接近摄像机的照明毂周围。
如上所述，光从漫反射器反射以在至少一个摄像机的视场提供照明。摄像机的视场可以包括固定到膜的电极的视野。如本文所述，电极可以是高反射的，诸如如果它们是由银组成。反射电极使光入射到电极上以反射到摄像机视场中，这可能会导致电极在显示器上显示为亮点，可能干扰观看过程。因此，在导管中包括适于减少光的从多个消融电极的至少一个消融电极镜面反射进入成像构件的视场的反射调节器可能是有益的。
在一些实施方案中，反射调节器是光吸收器。光吸收器可以定位在电极的底部与膜之间。在一些实施方案中，光吸收器是黑色粘合剂，其将电极的部分粘附至膜、以及充当光吸收器。
在一些实施方案中，反射调节器是抗反射涂层。示例性抗反射涂层包括，例如但不限于：TiO2的沉积薄层，MgF2，以及由直径约200纳米且隔开300nm 的范围的纳米颗粒组成的“蛾眼(moth eye)”结构，固定到或在适于减少反射的膜内部表面上产生的随机微结构。抗反射涂层可以附着到膜的仅一部分，诸如其中设置电极的部分。例如，抗反射涂层可施加到内部膜的仅远侧部分。
反射调节器将减少从电极底部反射的量，从膜内创建该膜和电极的更清晰图像。
当由至少摄像机提供的图像或视频显示在显示器上时，有利的是能够在视觉上识别显示器上的电极。例如，用户界面可用于控制任何电极的递送参数，并能够使医师容易地确定并确认视频上的给定电极是用户界面上的特定电极，这简化了流程并确保了正确的电极被激活并按照预期使用。
在一些实施方案中，导管包括与多个电极中的至少一个电极相关联的电极标识符，并且在一些实施方案中，导管包括具有多个电极中的每个电极的电极标识符。该电极标识符对于每个电极不必是唯一的，但在一些实施方案中，它对于每个电极是唯一的。该电极标识符符是视觉上可识别的并允许个体视觉上将标识符与电极相关联。
在一些实施方案中，电极标识符是设置在每个电极上或附近的字母数字字符。这种类型的标识符的示例如下描述和所示。例如，字母数字字符可被印刷在电极的背面上，或被印刷在与电极相关联的柔性电路的一部分的背面上。字母数字字符也可以印在电极附近的膜上，使得该标识符可以容易地与特定电极相关联。
在一些实施方案中，电极标识符是与一个或多个电极相关联的颜色。例如，电极可以是颜色编码的，使得用户可以视觉上识别每个电极。在一些实施方案中，一组电极可以具有特定的颜色，诸如连接到同一柔性电路的全部电极都是一种颜色。电极标识符的附加示例是电极的形状使得电极或电极组可以基于其形状被视觉上识别。例如，电极组可以是圆形、椭圆形、六边形、矩形、正方形等。每个电极也可以具有独特的形状。
电极标识符的示例是下面在从多个摄像机重叠的视场的情景中所描述的。
图10图示了三个柔性电路中每个柔性电路尾部终止在从气囊的远端向近侧延伸的终端41(一个用于每个柔性电路)并在外轴51内向近侧延伸，并且其固定到气囊和冲洗轴55的近端的外表面。该配置的近端方面也可以在图2B中看出。在图10中，可以看到六条传导导线18从该终端41中的一个终端向近端延伸，其中每一条与该特定柔性电路中的六个电极之一电连通。六条导线18延伸导管的长度，并与RF发生器连通。在一个备选实施方案(未示出)中，六条导电迹线 15延伸导管的长度，并与RF发生器连通。用于可视化系统的摄像机柔性电路 43还示出在图10中，从导管中的可视化系统向近侧延伸。
用于膜和柔性电路材料的示例性材料可见于于2013年10月23日公告的美国专利号8295902和于2012年3月22日公布的美国公开号2012/0071870中。膜材料的其它实例包括PET、聚氨酯等。用于反射器的示例性材料包括金属化涂料、填充有非导电白色颜料(诸如TiO、BaO、BaSO4)的硅树脂或聚氨酯树脂，优选是不导电的。用于电极的示例性材料包括银填充的硅树脂或尿烷。用于导电迹线的示例性材料是导电金属，包括铜或其它这样的导电材料。绝缘层可以是已知的介电材料。用于衬底的示例性材料包括卡普顿(Kapton)。
如本文所述，消融导管可以包括固定到膜的外部的消融和映射电极。在这样的实施方案中，组织映射的区域限制为由可膨胀结构限定的接触区域。但是，被映射的转子可以大于可膨胀结构的接触面积，使得正确映射用于转子的心房室更困难和费时。在一些实施方案中，消融导管包括可膨胀膜，并且还适于增加可以被映射到大于由可膨胀膜接触表面所限定的区域的区域。
在这些实施方案的一些实施方案中，映射臂适当坚硬(stiff)时可以提供限制消融元件意外进入肺动脉的一种方式，从而使得动脉壁的意外消融和随后的狭窄的结果风险最小化。
在一些实施方案中，其上设置至少一个映射电极的映射结构被保持在气囊的外侧，并且被收缩在递送导管的壁和消融导管外侧之间。映射结构可固定到消融导管的外部。在一些实施方案中，一个或多个映射结构可以是可变形的曲线(spline)，其使用已在心脏消融空间中描述。例如，映射结构可以由镍钛诺 (nitinol)制成并适于变形。当递送导管相对消融导管向远侧前进时，映射结构可因此从递送导管释放展开，并且可以收缩到收缩的递送构造。
在其它实施方案中，映射电极结构适于通过本文的消融导管的导向线管腔而被递送。
图11A和图11B描绘了示例性消融导管300，其包括承载在多个可重构映射臂308的表面上的映射电极302的阵列(为清楚起见只标记一个)。图11A是侧视图，图11B是远端视图。臂308一起具有“篮子(basket)”构型并且设置在膨胀膜306外部。在图11A和图11B中，臂308在从递送导管内释放后处于其膨胀构型。在递送和取回期间，臂308被收缩到递送导管和消融导管300之间的空间，并且适于通过递送导管缩回或递送经过递送导管的远端在释放时自膨胀。示出六条臂408，每条具有多个电极302，但是可包括篮子的更多或更少的臂。臂都可以固定到相同的映射篮毂(或由单片材料制成)，或者它们可以独立地被固定到消融导管。图11A和图11B示出具有臂308的导管300位于缩回位置，臂 308的近端缩回并且定位在递送导管和消融导管之间。臂308比在图11A和图 11B示出的膨胀构型中更靠近膨胀膜306的表面。
图13是示例性消融导管320的远端的远端图。在该实施方案中，消融导管包括承载多个映射电极322(只标记有三个)的备选螺旋结构328。螺旋映射结构可适于通过导向线腔323而被递送，或者它可以适于从递送导管和消融导管轴之间膨胀，类似于图11A和图11B中的实施方案。在图13的实施方案中，其中螺旋结构适于经由导向线腔被递送，在侧视图中螺旋可以在单一平面上，或当螺旋向远侧推进与组织接触时，螺旋可具有适于变形成单一平面的锥形构型。出于图13-图17的清楚，消融电极未标记在消融气囊上。
图14A是简化的侧视图，图示备选的消融导管340，其具有在其上带有多个映射电极342(只标记两个)的专用映射结构348。在本实施方案中，两个映射臂348具有如图所示的膨胀的环构型，并适于通过如图所示的导线内腔347而被递送。可能有多于或少于两个臂。图14B是备选实施方案的远端视图，其中映射结构350包括在其膨胀构型中的多个环。在本实施方案中，至少一个环352 具有的膨胀“高度”(从导管纵轴沿垂直该轴的线测量的距离)大于第二环354的高度。特别地，存在四条臂352，其具有比其它四条臂354的高度更大的第一高度。可以有不同高度尺寸的任意数量的环。
图15示出导向线腔360内为收缩构型的映射臂和电极362的示例性构型，并且仅是说明性的以示出如何可以将多个臂设置在导向线腔内。其中可设置更多或更少的臂。
图16示出示例性消融导管370的简化侧视图，其中映射臂378终止在它们相应的远端379。也就是说，每条臂具有自由端。导管370包括气囊376、导向线腔377、臂378上的映射电极372，类似于本文的其它实施方案。任何所述映射臂可以包括加强构件，诸如NiTi线，使得释放时映射构件呈现预定的形状。
通过导向线腔递送的任何映射臂可以备选地被配置为在消融导管和递送导管之间的空间中递送，反之亦然。
在其它实施方案中，映射臂可编织成圆锥形辫(braid)或辫状结构，当向远侧延伸时其直径会增大。
在使用中，可视化系统允许通过设置在气囊内的一个或多个摄像机观察对流程进行实时可视化。可视化允许整个流程被可视化，使医师能够评估组织接触的程度，并当发生时看到电极、组织和病变的形成。为清楚起见，图29仅图示了针对摄像机组件中四个摄像机之一的四个视场中的一个。图30图示了来自四个摄像机的四个视场，每个与至少一个其它视场重叠，以为医师提供治疗区域的360度视野(以导管的纵轴为参考)。虽然在四个图像的中心示出有盲点，但与当前实施方案中所用的那些不同的透镜系统可允许消除该点。由于围绕整个导管设置有电极，360度视野允许医师将利用围绕导管设置的电极的整个病灶可视化。包括在任何电极位置的病变形成的整个流程的可视化非常有助于医师。
本文重叠摄像机视场的描述与美国公开号2012/0071870中的公开内容有关，特别是图38H-图38R以及其文字描述。本公开的一个方面是一种使用来自附接到内窥镜导管的多个摄像机的图像以生成全景(panoramic)图像显示的示例性方法。在一些实施方案中，从多个摄像机捕捉的多个图像与至少一个其它图像重叠以创建围绕消融导管的纵轴的全景图像。两个或更多摄像机可以对可膨胀构件的各分段(从可膨胀构件内)和解剖进行成像，并且摄像机之间的几何关系是已知的先验(由设计或测量)、或使用气囊的共同解剖特征作为标志可从图像本身来估计。
通常，对于每个摄像机，计算围绕摄像机将像素映射成虚拟展开显示屏(例如圆顶形屏)的映射函数。然后采用逆投影(即使用摄像机作为投影机)将该图像回投到这个虚拟显示屏。使用包括混合或一些其它手段的合成来组合重叠区域中的数据。
图17是示例性可视化导管的远端部分的侧视图。图17示出远端部分的几何形状，其包括附接到导管的中心轴的远端的四个摄像机，导管由填充有生理盐水的膜所包围。每个摄像机从膜内对闭合膜的截面成像。图17所示的圆锥形状代表多个摄像机中的一个摄像机的视场。在本实施方案中，虽然图17中未示出，但多个射频电极被固定到膜的外部。当远侧部分被定位在心脏腔室(诸如左心房)内部时，摄像机能够对气囊外部的血液或组织以及气囊的内表面可视化。这提供了一种方式，以证实在开始消融之前该电极与组织接触并且气囊相对于解剖标志(诸如肺静脉)被适当定位。
图18A-图18D示出四个摄像机的轴相对于导管轴的纵轴的取向。图18C所示的箭头AP、BQ、CR和DS表示相应的摄像机的轴。OM是导管轴的纵轴。参数“c”是在导管轴OM的轴线和摄像机的轴线之间的最短距离(参见图18A)。摄像机轴线相对于导管轴OM的轴线还呈角度φ(参见图18B)。膜的远端表面可以建模为椭圆形旋转体，如图18D的侧面几何视图所示。参数a和b限定椭圆体。如图18D标记的椭圆体的中纬线(equator)与图18D所示的点“O”的距离为″ d″。具有轴线CR的摄像机的成像平面与C的距离为e，如图18D所示。
图19示出四个摄像机视场中的一个视场的几何形状，并且所有四个具有相同的几何形状。成像平面的像素P(u，v)通过等式(1)和(2)与空间中的点Q(x，y， z)有关，其中f是摄像机的焦距。
Figure BDA0002051383410000191
和
Figure BDA0002051383410000192
此外，由摄像机捕捉的图像可以具有镜筒像差(barrel aberration)。图20示出由代表性摄像机获取的规则网格图案目标的图片。如可以看到的，镜筒像差导致网格点远离中心390以呈现为更小并且压缩到彼此。
可以通过使用网格目标来确定将原始像素坐标P(u，v)映射到由于镜筒像差造成的失真的像素坐标系
Figure BDA0002051383410000193
的映射函数：
Figure BDA0002051383410000194
椭圆形气囊的三维表面可以使用图21A-图21C所示的参数化而被展开成二维平面。在图21A中，参数a和b将气囊描述为椭圆旋转体。参数m对应于沿气囊表面从顶点(zenith)开始的弧长。在图21B中，旋转角度γ描述了旋转体的方位角。在图21C中，展开的气囊表面通过极坐标中的参数(m,γ)或直线坐标中的参数
Figure BDA0002051383410000201
来限定。
气囊表面上的点可以是(x,y,z)。平面展开图像可以通过如下展开气囊面由椭圆气囊的几何来构建：
Figure BDA0002051383410000202
其中，θ＝g(m)...(5)
g(m)是公知的“第二类完全椭圆积分。”展开的二维表面通过极坐标中(m,γ) 或直线坐标中
Figure BDA0002051383410000203
来限定，其中：
Figure BDA0002051383410000204
总之，表1(下面)的参数描述这个多摄像机系统的摄像机几何。
表1
Figure BDA0002051383410000205
使用表1的参数，可以计算对应于由给定摄像机所产生的图像的每个像素的展开气囊上的点的坐标
Figure BDA0002051383410000206
然后该像素的强度可以涂在展开的气囊表面上。如果一个以上摄像机将数据投射到展开的气囊表面上的同一位置，则可以使用任何数目的示例性方式(诸如混合、最大值、自适应混合、α混合、加权平均等) 来组合该数据。这些技术落入“合成”的一般类别中，如在Foley等人，“Computer Graphics Principles and Practice”，1990年，AddisonWesley出版，第2版， ISBN0-201-12110-7中所描述的。在来自两个或更多摄像机的图像的重叠区域中，由于该几何模型不准确，下层解剖结构可以稍微不对准，甚至在上述步骤以极其对准图像后。在这种情况下，给定的组织结构可以在重叠区域中出现两次，类似于复视(doublevision)。为了解决这个问题，通过使用特征追踪可局部扭曲图像。参见2003年12月9日公告的Sumanaweera等人的美国专利6659953，标题为“morphingdiagnostic ultrasound images for perfusion assessment”，描述了示例性局部扭曲(warp)技术。
图22示出了使用已知的图案模拟的一组四个摄像机图像，在这种情况下，消融电极601涂在膜上。电极601可以在图1A-图1D中所示的18个电极的图案中。电极601还具有与它们相关联的标识符，在这种情况下为独特的字母数字字符。
图23示出了通过使用上面描述的方法将图22的图像回投到展开的气囊表面上而生成的全景图像。图25还图示了印刷在每个电极上的数字形式的示例性电极标识符，以使每个电极可以被视觉上识别。图25还图示了采集到的图像是如何包括共同区域到与它们相邻定位的图像，并且该共同区域被重叠以创建全景图像。
在图24中，通过将组成图像回投到展开的气囊表面而生成全景图像，但电极370不具有与它们相关联的电极标识符。图25示出了使用上述方法通过四个摄像机获得的组织图像。图25示出了使用本发明通过将这些图像回投到展开的气囊而生成的全景图像。
上述示例性方法获得了来自多个摄像机的每个摄像机的图像，并且组合所述图像以产生全景图像。如上所述，使用几何变换可以对来自每个摄像机的图像进行变形。变形可以包括与摄像机之间的已知几何关系相关联的信息。变形过程可以包括使用合成在图像的重叠区域而生产的几何变换。该过程可以包括使用加权平均。该过程包括a混合。变形过程可以包括使用特征追踪在图像的重叠区域生成的几何变换。摄像机之间的几何关系的表征可以包括使用实验确定的光学目标。通过几何建模摄像机可以解析地确定几何关系，固定件(fixture) 含有摄像机和气囊。几何变换可以包括将气囊映射到平面表面上的几何变换，同时保持3D表面上任何的任意组的点之间的距离。
本公开的一个方面是一种机电设备，提供用于借助线性位移芯将AC功率从电源转移至负载的连续或半连续调整。机电设备可与本文的任何消融导管一起使用。对线性可变差动变压器(“LVDT”)的操作的理解有助于讨论本公开的这一方面。LVDT包括连接到AC信号源的主要中心线圈绕组和串联连接到负载的一个或两个“次级”线圈绕组。铁磁芯将初级线圈处的磁场耦合到次级线圈，从而在线圈两端产生电压差，其大小随芯位移而变化。
本公开的这一方面是仅具有单个初级线圈和单个次级线圈以及芯位移的 LVDT传感器的衍生物。此衍生物被称为线性位移功率变压器(“LDPT”)，提供了借助芯位置将功率从初级线圈转移到次级线圈的装置。当芯跨越两个线圈存在时，最大(功率)耦合发生在初级初级(“P”)线圈和次级(“S”)线圈之间。当芯被移位出“P”或备选地被移位出“S”时，耦合连同功率转移会降低。
图26A-图26C提供了这方面的说明示意图。在图26A中，铁磁杆芯101与次级线圈“S”而不是初级线圈“P”对准，图27的图形上绘制了导致最小电流输出的解耦状态。图26B示出了杆芯被移动以在耦合场fP和fS的理论上中间点与线圈“P”部分地对准，以产生最大50％的理论电流输出。图26C示出了杆芯被移位到与线圈“P”和“S”对准的充分耦合场fP和fS，提供了最大电流输出到负载。
图28A和图28B表示该方面的一个实施方案，其中芯453通过微步进马达和螺杆机构454移位。初级绕组451和次级绕组452沿着芯453通过其可以移位的公共轴线而径向缠绕。图28A示出了在最小输出位置的LDPT，图28B示出了在最大输出位置的LDPT。功率转移是电力无噪声的，并且使用铁杆芯会最小化涡流损耗。
这种可变变压器特别用于需要多信道、低噪声、线性RF功率分布系统的治疗系统。在这种线性功率分布系统中，LDPT可包括在每个输出信道、选择输出信道或者可替换地作为所有信道的电源。
这种治疗系统特别用于提供透皮消融治疗，诸如用于本文所述的心房纤维性颤动的治疗。
本公开的一个方面是的组件，其包括初级绕组、次级绕组、铁磁芯、线性移动铁磁芯的路径，其中所述绕组被同轴定位，沿着该同轴轴线可移动的铁磁杆，其中适配所述铁磁杆使得它可同时邻近两个绕组定位，并且其中所述铁磁杆适于被定位成邻近仅一个绕组。铁磁芯可以通过步进马达和螺纹机构来移位。
本公开的一个方面是通过移动在包括两个绕组的变压器内的铁磁芯来调节到RF电极的输出功率的方法。本公开的一个方面是通过移动变压器内的铁磁芯来调节到RF电极的功率的方法。在任一方法中，RF消融电极被透皮地递送到生命体中的治疗部位。
在示例性的使用方法中，该导管被用来在心律不齐的治疗中消融心脏组织。使用已知的接入流程(包括导向线和导管引导技术)使导管进入左心房。然后充气/冲洗流体被从流体源泵送下充气/冲洗腔52以将气囊膨胀为左心房内图1A-图 1C中所示的构型。摄像机可以在手术过程中的任何时间被激活，但一般在膨胀前，因此医师可以观察到是否有膨胀的任何问题。在这一点上可以看出气囊是由血液包围。导管被远侧地朝向心房壁推进，并且当气囊接触组织时血液将被移位，从而提供了组织的清晰视图。然后医师可根据待映射的希望的治疗组织或希望的区域来确定是否需要移动气囊。本文设备中所述可视化系统的一个优点是，医师仅通过观看显示摄像机视场的显示器就可以很容易地观察到气囊何时被适当地定位。这也简化了系统，即不需要执行反射能量的分析，如同在心脏消融的以前的一些尝试中的情况。
根据可视化信息(诸如围绕肺静脉的适当布置或映射电信息)，一旦已经确定该气囊已被适当地定位在治疗部位，通常示于图35和图36的外部控制台用于激活某些电极和控制该过程的能量递送参数。RF发生器生成RF能量并且将其递送到电极。本文示出的实施方案的电气方面的示例性示意图示于图33。应当理解，包括18个信道，但只示出三个。在未示出的备选实施方案中，可以包括更多或更少的信道。如图33所示，系统的映射能力被示于电极的右侧。每个电极可以在单极或双极模式下使用，并且可用每个电极来测量阻抗和电压。
该发生器根据需要被配置成使得电极可用于映射组织、消融组织和刺激组织。消融心脏组织来治疗异常信号在本文进行一般描述且是已知的。但是，发生器还被配置为生成并递送电组织刺激信号到电极，以使电极刺激心脏组织。图33的示意图示出了每个电极可被选择用于消融或刺激，同时来自每个电极的映射连续地发生。映射部分包括配置成过滤掉消融带宽以及可被递送或以其它方式存在的其它非必要带宽的滤波器，从而可以连续发生映射。本文的公开内容因此包括发生器，被配置为使得每个电极可用于同时映射和消融组织，或同时刺激和消融组织。该系统也被配置成使得消融、刺激和映射都可以同时发生，虽然刺激和消融不会在相同电极的任何给定的时间发生。此外这些方法还可以顺序地执行。
心脏组织的刺激可以由于许多原因来完成。在一个示例性实施方案中，可以在诊断流程期间执行组织的刺激，以确保电极都在工作。例如，RF能量可以被递送到第一电极并用另一电极感测，从而在电极对之间递送能量，以确保该电极对正在工作。在此示例性使用中，刺激能量可以在气囊与组织接触前或它与组织接触后被递送，如血液通常具有足够低的阻抗，从而妨碍诊断测试。在一个备选实施方案中，可以刺激心脏组织同时用其它电极来消融组织。例如但不限于，三个电极可用于递送消融能量来产生三个电极之间的病变(例如，线性消融)，而位于病变一侧的电极可用于递送刺激能量到在病变另一侧上的电极，以确定该组织是否被有效地消融。示例性的组织刺激递送信号能力包括0-20mA 的电流，0-100毫秒脉冲宽度，高达300bpm的重复率。更优选为0-10毫安，0-10 毫秒，高达180bpm。以这些方式刺激心脏组织与映射的不同在于映射测量阻抗，同时刺激递送被配置以刺激心脏组织的能量。本公开因此包括在消融术期间刺激心脏组织的方法，包括在实际消融前、消融期间或已发生消融后。
图31A-图31C图示消融肺静脉口周围的心房组织以隔离肺静脉的示例性方法，并由摄像机的四个视场生成的视图来对其显示。图31A-图31C是使用该系统时医师将看到的视图。再者，可以根据摄像机组件和其中的摄像机布置来除去中间的盲点。在图31A中，该气囊已被推进到与肺静脉腔1502的口(ostia)1501 周围的心房组织相接触。图31A没有电极已经被激活，虽然映射流程也可能发生在这个阶段，以评估心脏组织的传导。图31B示出正被激活的某些电极“A”和在电极接触和施加电源后开始形成在组织中的病变区域1503。在这个实施例中指明为“B”的电极没有被激活。图31C示出了组织的持续消融和通常延伸在肺静脉口周围的病灶区域1504的形成。
图32A-图32C图示使用本文的系统创建治疗转子(rotor)的病变的示例性方法。图32A示出气囊向前抵着心脏组织而不是窦口区域，那里没有电极被激活。图32B示出仅电极“A”被激活，以及在电极与组织接触并被激活处开始形成消融病变1601。在本实施方案中，电极A是距三个柔性电路中的每个柔性电路最远侧的电极。图32C示出持续消融和靶向转子的病变区域1604的形成。中间的盲点隐藏了病变延伸在不能被看见的组织上。在使用的备选实施方案中，三个以上的电极可用于执行转子消融，诸如四个电极。
本公开的一个方面是叠加由摄像机提供的一个或多个图像的方法，其具有信息或图像指示心脏组织的特征和消融导管的特征中的至少一个。叠加的图像 (或叠加的信息和图像)在视觉显示器(诸如监视器)上呈现给医师，并且可以是远程用户界面的一部分。该方面包括适于叠加图像的方法和系统。本文的方法和设备还适于获得信息和叠加图像。
正被叠加的信息可以是心脏组织的特征或消融导管的特征的任何合适的视觉指示。
在一些实施方案中，叠加到来自摄像机的图像的信息是接触可膨胀构件的心脏组织的电活动。
在一些实施方案中，叠加到来自摄像机的图像的信息是消融电路的局部阻抗。
在一些实施方案中，叠加到来自摄像机的图像的信息是与气囊相对的心脏组织的温度。
在一些实施方案中，包括CMOS摄像头的摄像机适于响应于红外范围内的光。该响应可用于估计消融之前、期间和/或之后的组织的温度。该响应可以通过算法来解析并显示叠加至来自摄像机的可视光图像。
在一些实施方案中，加速度计被放置在消融气囊中、上或附近的位置。加速度计可用于检测气囊相对于重力的取向。加速度计可以产生被用来确定相对于初始位置的加速度计的位置的加速度数据。该位置可以被用来构建由气囊访问的位置的数据库和/或由气囊上的电极采集的信息和/或施加至气囊电极的RF 功率。采集的信息可用来重建模型以向医师提供有关被治疗的位置和需要被治疗的位置的指导。
图38图示可以叠加在来自摄像机的图像上的示例性信息和指示符。指示符 402和404是传达邻近电极的组织的温度的示例性方式。例如，指示符402是定性指示温度的一系列线，诸如“媒介”。指示符404是一系列交叉线并且可以指示“高”的温度。任何类型的视觉指示符可以因此被用于指示与任何电极相邻的一个或多个组织区域的定性温度。
叠加信息406提供了组织温度的定性指示，在该实施例中为99度。信息406 毗邻电极的图像，而信息408是电极图像上的信息。指示符410是叠加在电极顶部上的红色，提供了“热”的定性指示。信息414和416被叠加以指示相应的电极是“开(on)”和“关(off)”。
在一些实施方案中，叠加信息是所有相同类型的信息。例如，每个电极可以同时叠加指示组织的温度的信息。在其它实施方案中，叠加信息的类型对于任何电极可以不同。
可以被叠加的信息类型的附加的示例包括电阻抗，这可以使用本文的任何指示符(例如，颜色、数字)被定量或定性可视化。此外，映射信号也可以叠加在摄像机图像上。
图39表示用于施加到气囊的外表面的示例性柔性电路，气囊具有薄的聚酰亚胺衬底101，约0.002-0.003”厚，并且总的结构厚度介于0.004-0.006”之间。
轮廓是最终的消融焊盘102的轮廓(只有大正方形和三角形)。孔(aperture)103用于盐水流动。电路迹线104终止于消融焊盘上的暴露区域。导电银涂层用于创建消融焊盘的几何形状并且暴露的迹线提供了导电性。
备选地，黑色粘合剂可用于使涂银消融焊盘102下方的区域变暗，以防止气囊内部的反射，如本文所述。采用聚酰亚胺衬底101的一种方法能够消除黑色粘合剂，提供更薄和更顺从的安装表面。
介电区域105被提供以防止到血液或其它介质的串扰(crosstalk)和导电性。柔线电路的近侧具有在其处导线被附接的两个小焊盘106。
图39所示的装配的柔性电路可以被附着至图40所示的气囊201，这种气囊位于中心杆(stem)202周围，并且这种杆具有捕获气囊内表面的图像的系统(未示出)并将这类图像传输到患者体外的显示器。可选的长突起203位于缠绕在气囊的前方周围的三角形焊盘的远端，以创建用于电路的物理锚。
另外，加速度计204被放置在消融气囊中、上或附近的位置，这样的加速度计可用于检测气囊相对于重力的取向并构建本文所述的治疗相关数据集。
当医师如本文所述移动导管，更具体地，当医师绕导管的纵轴旋转系统时，该图像显示器将示出固定的气囊的内表面和移动的气囊外的一切(例如，心脏组织)。这是由于这样的事实，即在这里的实施方案中，摄像机相对于导管和气囊系统被固定。
图41A和图41B图示了如本文所述的从呈现给用户的显示器上的四个摄像机阵列的复合视图。图像被映射到合成图像，其表示在气囊内的轴上由气囊承载的摄像机的布置和取向。映射对齐(registration)依赖于每个摄像机视场内映射彼此上方的映射共同特征，其中两个或更多图像内存在共同特征。如图所示，一个电极，即取向对齐电极，是通过在电极之前印在气囊上的星号(如图所示) 形状的标记来识别，并且对摄像机是可见的。在其它实施方案中，每个电极可用自己独特的标识符来标记，或者一些或所有电极可以具有有助于识别它们的不同形状。共同的固定特征(相对于摄像机)包括迹线、电极和其它固定的标记。图41A图示分别由电极514和510创建烧伤502和504后获取的初始图像。该气囊以肺静脉506为中心。图41B图示了气囊被旋转之后通过摄像机阵列捕捉的第二图像。每个合成图像已被处理从而固定特征(相对于摄像机)以这样的方式被映射到用户显示器：使得对齐标记(因此为整个图像)旋转的量相等并且与对于围绕合成图像(诸如烧伤502或504)的中心的一个或多个解剖特征的质心而测定的旋转相反。通过这样，固定特征的图像将会旋转，同时当气囊被操纵时，固定特征后面的图像部分将保持固定。
因此这里公开了一种系统，通过图像处理以示出气囊内表面旋转同时保持气囊外部的一切(例如，组织)的图像静止或固定。以这种方式，不为导管的一部分的一切的图像将保持固定，并且为导管的一部分的一切的图像将在视频中示出为旋转。在此备选实施方案中，用户观察的图像示出固定特征(例如，电极) 在旋转而解剖特征保持静止。解剖特征在组织中是非固定特征或非气囊相关的特征，诸如此视图所示，肺静脉和通过消融产生的烧伤的图像。这可以完成，甚至当摄像机移动时固定特征也移动的情况下。保持该组织对于用户是固定的并使得该设备的部件移动，允许医师更好地控制该设备相对于组织的运动。为了便于这一过程，计算相对于固定特征的位置的一个或多个关键解剖特征的质心的平均旋转。然后使用旋转的均值或其它合适的表示以旋转呈现在用户显示器上的合成图像。
图37图示了心脏消融系统的示例性框图，其细节在本文中描述。可以结合图38中的任何系统部件，并与本文所述的任何单个部件一起使用。
设置在可膨胀构件上的电极的数量和布置，其中每一个是可单独寻址的并且可用于以单极或双极模式递送能量，提供了各种病变形成而无需除去和插入分离的RF导管。图31和图32所示的示例性方法仅是示例性的。线性病变和弧形病变是可以根据希望的消融术而创建的病变形状的附加示例。在本文提供的特定示例中，有18个可单独寻址的电极设置在可膨胀构件10的基本上远端部分。其中一些电极可以被通电，而另一些则不能，这允许在治疗心律失常的心脏或其它组织中进行许多不同的病变形成。任何电极可以双极模式与任何其它电极一起使用。病变的深度和宽度可以通过选择和/或改变以双极和单极构型使用什么电极组合来进行控制。单极构型产生更深更窄的病变，双极构型产生较浅较宽的病变。
本文的设备的一个优点是，电极的数量和布置允许各种病变形成而不需要除去和插入新的导管。而且，可视化系统允许整个流程被可视化。
图7图示了结合有可滑动的护套(sheathing)工具100的设备的远端，护套工具100包括护套管102。在使用中，气囊12如前所述被收缩，然后护套工具滑过收缩的气囊。护套管102然后被适配到递送导管中(未示出)。然后除去护套固定件，留下递送导管内的收缩气囊用于前进到递送位置。
本公开的一个方面是包括同心护套作为转向机构的递送导管，其具有映射系统嵌入远侧尖端，其中映射篮子在递送期间留在两个同心轴之间的空间中，并且在递送时映射系统被向前推出到心脏腔。可部署的映射篮子的例子如上所述。然后消融导管可通过在合适位置的具有映射篮子的递送导管被递送。然后使用映射篮子上的电极可以识别用于消融的目标位置，然后用消融导管来消融目标位置。此外可以识别消融导管的位置并通过映射篮子来验证。
本公开的一个方面是一种消融导管，其包括直径约1厘米至约5厘米的电极结构并留在可充气或可膨胀结构的端部，并且其可以包括以下：具有承载多个电极的气囊的消融导管。在一些实施方案中，多个电极可交替用作单个消融电极，然后作为能够监视电极间阻抗的单个阻抗感测电极的集合。这种测量有助于表征由消融引起的烧伤的效力和/或在烧伤前或后映射所述消融。在一些实施方案中，接触压力敏感电极可被掺入作为验证电极与心脏组织适当接触的手段。在许多实施方案中，如本文其它地方描述的，提供冲洗，其中冲洗系统包括压力传感器。在这种实施方案中，接触压力可以由冲洗系统内的压力变化来推断，伴随有冲洗流端口处挤压组织的外流阻力增加。在其它实施方案中，使用气囊构型内的气囊，使得冲洗压力可以与充气压力隔离。充气系统内的压力变化然后与接触压力直接相关。在另一备选方案中，与冲洗相反，可以通过气囊内的再循环提供冷却。
在一些实施方案中，通过阻抗匹配测量电极的接触压力是。表征病变的质量的备选手段是测量超声波通频带中声阻抗的变化。声阻抗将从正常组织作为温度和变性的函数来改变。在这种实施方案中，可将前视美国应答器结合到气囊中或气囊的表面上。这种传感器可实现为一个或多个应答器的阵列、一个或多个发射器的阵列和一个或多个接收器的阵列，或单个应答器。
在一个备选实施方案中，可以通过微波辐射测量来监测病变的温度。
图42和图43图示消融导管的示例性实施方案，其中气囊被配置用于接触(物理)测量。因此，气囊和因此的电极的接触压力通过内部气囊压力的变化来表征，该变化是当电极挤压组织时由气囊中经过电极的冲洗孔被堵塞引起的。气囊挤压组织时压力将瞬时增加然后达到新的平衡，并伴随有与冲洗端口的堵塞或部分堵塞相关联的外流阻力的任何降低。这种接触压力可以通过先前的实验被映射到电极接触表面区域。
随着气囊中透明窗口的视觉外观的变化，可膨胀结构内包括摄像机的视觉接触监视器监测接触。视觉外观的变化是由血液和组织的外观差异导致。
接触监测可用于控制功率递送。通过本文所述的任何手段获得的电极接触的测量可以用于介导(mediate)递送到电极的功率的量。一旦控制算法限制到电极的功率，会使得每个接触表面区域的功率保持在恒定水平。
图42图示了被配置成用于接触测量的原型(prototype)气囊。气囊714被固定到轴711的端部。应变计713被附着到轴711和与应变计放大器(未示出)接口的引线712。有两个附加应变计以正和负120度被被附着到轴。图43是类似设备的代表，其中所有三个应变计被配置在轴751上应变计组件755中，其包括到应变计组件的引线。气囊754包括电极756。在备选实施方案中，可以通过一个或多个压力传感器来监视气囊近端附接附近的室中布置的流体或凝胶的封闭体腔的压力。在其它实施方案中，应变计可以被替换为位移传感器。如上所示，可以将来自这种感测系统的测量映射到电极接触表面的估计。图42的气囊直径为2厘米，图43的气囊直径可以为1-3厘米。图43的设备上的电极的构型包括八个电极。这些小的轮廓允许小的递送尺寸和精确的可操纵性。这种系统与单个RF发生器兼容，并且可以包括冲洗系统(未示出)以最小化不必要的伤害。
在如本文所述的心房纤维性颤动的治疗中RF消融的使用造成到食管的热损伤的风险。本公开包括测量RF消融期间食管壁的温度的系统和方法。在一些实施方案中，气囊被置于食管中并被充气以与食管壁接触。沉积在气囊上的温度敏感材料的图案测量由RF消融引起的温度变化。电路感测温度变化以提醒操作员。
热敏电阻是一种电阻随温度而变化的电阻器。负温度热敏电阻(NTC)的电阻随温度升高而降低，这是由于电子迁移率增加以及后续的电流传导能力增加所致。商用NTC热敏电阻是使用基本陶瓷技术由锰、镍、钴、铁、铜和钛的常见金属氧化物制成。在该基本工艺中，在适合的环境中烧结金属氧化物粉末和适当粘合剂的混合物并被配置以实现希望的温度系数特性。
初始NTC热敏电阻是使用硫化银(Ag2S)粉末制造的。最近，已经使用低温固化聚合物浆料和柔性箔形式的聚酯基材通过丝网印刷(screen-printing)整体制造基于硫化银的小型化平面银离子特异性电极(Sensors and Actuators B 96,2003, 482-488)。表面上，除了感测银离子外，这种结构也可以对温度敏感。
温度敏感性材料的图案沉积在柔性气囊上，其被尺寸化以阻塞食管。该图案包括两个柔性热敏电阻(flextors)。两个柔性热敏电阻用于电池供电的惠斯通电桥电路以测量两个柔性热敏电阻的温差。当放置在食管中时，感测由RF加热引起的温差。如果温差超过极限，则电路会提醒操作员修改RF消融治疗。
提高温度测量灵敏度的附加方式可能通过柔性热敏电阻图案的设计。如果该图案是环路且该环路作为直径地丝网(screen)在气囊上，则它可能会感测由消融电极生成的RF场的近场分量。将电路连接到柔性热敏电阻之一以测量由其选择的RF能量。在RF消融开始时，操作员旋转气囊轴，使得由柔性热敏电阻接收的RF信号被最大化。这意味着，柔性热敏电阻最接近RF源(消融电极)和之后的被加热的组织。在这种对准中，当一个柔性热敏电阻处于加热场，而另一个处于气囊的另一侧而不被加热时，差分感测被增强。图44图示了在左心房的消融气囊500，食管温度气囊502定位并在食管506中充气，温度传感器506具有环路构型。主动脉弓508和三尖瓣510也示出以供参考。
图45图示包括心内膜导管和心外膜导管的一个实施方案。导管在其主体上和/或它们的远端上具有电极，诸如本文所述。心内膜电极被定位在心脏腔的内部，并且心外膜电极被定位在心外膜组织上的这类腔的外部。电极被定位成彼此相对跨过限定心脏腔的壁。电极的组合以这样的方式被通电，即电流从心外膜电极向心内膜电极流动，或反之亦然。图45图示定位心内膜导管和心外膜导管的方法。

Claims (10)

1.一种消融导管，包括：
可膨胀膜和固定到所述可膨胀膜的外部的多个消融电极中的至少一个消融电极；
成像构件，其设置在所述可膨胀膜内，所述成像构件具有视场；
光源，其设置在适于朝向所述成像构件的所述视场而递送光的可膨胀构件内；以及
反射调节器，其适于减少光从所述多个消融电极中的所述至少一个消融电极到所述成像构件的所述视场中的镜面反射。
2.根据权利要求1所述的消融导管，其中所述反射调节器是光吸收器。
3.根据权利要求1所述的消融导管，其中所述反射调节器是在以下各项中至少一项上的抗反射涂层：气囊的内侧，或所述至少一个消融电极。
4.根据权利要求1所述的消融导管，其中所述多个消融电极中的所述至少一个消融电极由银组成。
5.根据权利要求1所述的消融导管，其中所述反射调节器是光吸收器，其中所述光吸收器被定位在所述至少一个消融电极的底部与可膨胀膜之间。
6.根据权利要求1所述的消融导管，其中所述反射调节器是光吸收器，其中所述光吸收器是黑色粘合剂，其将所述多个消融电极中的所述至少一个消融电极的部分粘附到所述可膨胀膜。
7.根据权利要求1所述的消融导管，其中所述反射调节器是包含TiO2或MgF2的抗反射涂层。
8.根据权利要求1所述的消融导管，其中所述反射调节器是抗反射涂层，所述抗反射涂层包括由直径约200nm且隔开300nm范围的纳米颗粒组成的结构。
9.根据权利要求1所述的消融导管，其中所述反射调节器是附着到所述可膨胀膜的仅一部分的抗反射涂层。
10.根据权利要求1所述的消融导管，其中所述反射调节器是施加到所述可膨胀膜的仅远侧部分的抗反射涂层。
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