CN107613836B - 在用于电磁导航的系统和方法中使用的具有传感器的医疗器械 - Google Patents

在用于电磁导航的系统和方法中使用的具有传感器的医疗器械 Download PDF

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CN107613836B
CN107613836B CN201680032082.5A CN201680032082A CN107613836B CN 107613836 B CN107613836 B CN 107613836B CN 201680032082 A CN201680032082 A CN 201680032082A CN 107613836 B CN107613836 B CN 107613836B
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T·P·克劳利
D·J·米尔
D·J·塞尔达
J·B·斯托派克
D·M·科斯特洛
L·A·科伊拉克
K·E·贾斯珀森
J·D·谢尔
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Abstract

本发明提供了一种医疗器械，该医疗器械包括印刷式传感器、表面、至少一种非导电材料和至少一对触件。传感器具有形成在导电材料上的至少一个线圈。表面适用于接收印刷式传感器并且可被放置在EM场中。至少一种非导电材料覆盖传感器的至少一个线圈。医疗器械包含多个导电层和多个非导电层。至少一对触件电连接至至少一个线圈并且可连接至导电层，该导电层耦接到测量设备，该测量设备基于EM场的磁通量变化来感测感应的电信号。基于传感器中的感应的电信号来识别医疗器械在EM场的坐标系中的位置。

Description

在用于电磁导航的系统和方法中使用的具有传感器的医疗 器械
技术领域
本公开涉及一种包括传感器的医疗器械以及其中传感器的位置可被检测和跟踪的系统。更具体地讲，本公开涉及识别具有传感器的医疗器械在电磁场中的位置的系统和方法。
背景技术
电磁导航(EMN)有助于增加内脏器官治疗和疾病诊断的可能性。EMN 依赖于非侵入式成像技术，诸如计算机断层扫描(CT)扫描、磁共振成像 (MRI)或荧光技术。这些图像可被配准到患者在所产生的磁场中的位置，并且因此可以参考图像来识别放置在该场中的传感器的位置。因此，EMN与这些非侵入式成像技术结合用于识别目标的位置，并帮助临床医生在患者体内导航到目标。
在医疗器械在患者气道中的定位领域中的当前市售系统的一个特定示例中，传感器被放置在称为可定位引导件的探头的端部，并且穿过延伸的工作通道(EWC)或导管，然后该组合被插入支气管镜的工作通道中。EWC 和具有传感器的探头随后导航到患者体内的目标。一旦到达目标，可以移除可定位引导件(即，传感器和探头)，并且可以使一个或多个器械(包括活检针、活检刷、消融导管等)穿过工作通道和EWC以获得样本和/或治疗目标。然而，在这一点上，由于具有传感器的可定位引导件已经被移除，所以不能精确地知道EWC的远侧端部以及引申开来地任何可能穿过其中的器械的确切位置。
由上述非侵入式成像技术生成的图像无法提供实时视频成像的分辨能力。为了实现实时视频，临床医生可以利用内窥镜的特征结构。然而，内窥镜受到其尺寸的限制，因此不像EMN中通常使用的工具那样能够导航到肺部的胸膜边界和其他非常狭窄的通道。替代方案是可视化器械，该可视化器械插入穿过内窥镜的EWC和工作通道并且其尺寸可被设定以达到诸如胸膜边界的区域。
然而，与可定位引导件一样，一旦可视化器械被移除，EWC的远侧端部的位置就不明确。一种使用的技术是将一个或多个标记物放置到目标附近的组织中，并使用荧光镜透视来确认EWC和标记物以及任何后续穿过 EWC的器械的位置。由于EWC的直径较小，所以同时插入多个器械可能是不切实际的。因此，为了可视化、诊断和手术，重复插入和移除器械是必需的。这种重复的插入和移除延长了诊断或手术的时间和精力，并且相应地增加了患者的成本。因此，希望减少插入和/或移除器械的次数以缩短诊断和手术所需的时间，同时增加EWC和穿过EWC的器械的位置(包括成像模态)的准确性。
发明内容
如本文所用，术语“远侧”是指正在被描述的离用户较远的部分，而术语“近侧”是指正在被描述的离用户较近的部分。此外，就一致性而言，本文详述的任何方面和特征可以与本文详述的任何或所有其他方面和特征结合使用。
根据本发明提供的是一种具有远侧部分和近侧部分的医疗器械，该医疗器械包括：印刷在医疗器械的远侧部分上并且具有由导电材料形成的至少一个线圈的传感器，覆盖所述至少一个传感器的所述至少一个线圈的至少一种非导电材料，周向围绕医疗器械的近侧部分印刷的导电层，印刷在所述导电层上的非导电层，以及电连接至所述至少一个线圈并且耦接到所述导电层的至少一对触件，所述导电层可连接至测量设备，所述测量设备被配置成基于电磁场的磁通量变化来感测感应的电信号，其中基于传感器中的感应的电信号来识别医疗器械在电磁场的坐标系中的位置。
根据本公开的方面，医疗器械包括在医疗器械的远侧部分上的基底非导电层，导电材料印刷在该基底非导电层上。传感器可以包括印刷或制造在医疗器械的远侧部分上的导电材料和非导电材料的多个层。每个导电层可具有不同的构造，包括导电材料的不同的节距角和/或环的数量。
根据本公开的另外的方面，医疗器械的近侧部分包括印刷在医疗器械的近侧部分上的多个导电层和多个非导电层。每个导电层耦接到传感器的导电材料中的一者。导电材料还可以通过通孔连接至导电层。导电材料可以进一步形成螺旋形，该螺旋形可以逆时针或顺时针方向形成。在实施方案中，医疗器械的外表面由ETFE、聚四氟乙烯、聚酰亚胺或非导电聚合物制成。导电材料可为铜、银、金、导电合金或导电聚合物。医疗器械可以是延伸的工作通道、成像器械、活检钳、活检刷、活检针或微波消融探头。
附图说明
当参考附图阅读各种实施方案的具体实施方式时，本发明所公开的系统和方法的目的和特征对于本领域的普通技术人员将变得显而易见，其中：
图1是根据本公开的实施方案的用于识别医疗器械的位置的系统的透视图；
图2A是根据本公开的实施方案的导管引导组件和医疗器械的侧视图；
图2B是图2A的指示区域的细节的放大图；
图3A示出了根据本公开的实施方案的作为绕线且印刷在医疗器械的远侧部分上的传感器；
图3B至图3E是根据本公开的实施方案的多个医疗器械的透视图；
图4是根据本公开的实施方案的印刷有电路的医疗器械的远侧部分的展开图；
图5是根据本公开的实施方案的在多层电路中包括双线圈的传感器的示例性设计；
图6A是根据本公开的实施方案的在多层电路的第一层中的两个传感器的示例性设计；
图6B是根据本公开的实施方案的在多层电路的第二层中的传感器的示例性设计；
图6C是医疗器械的近侧部分的示例性设计，其中围绕该医疗器械印刷有一系列导电层和一系列非导电层；
图7是根据本公开的实施方案的在医疗器械的表面上印刷传感器的印刷机的图示；并且
图8是根据本公开的实施方案的用于在医疗器械上印刷传感器的方法的流程图。
具体实施方式
本公开涉及医疗器械、通过使用传感器来识别医疗器械在电磁场中的位置的系统和方法。传感器可以直接印刷在医疗器械上，或者单独制造然后固定到医疗器械上(包括成像器械)。由于传感器可以与医疗器械一起插入患者体内，所以医疗器械的位置是实时识别的。此外，传感器可以与其他成像模态一起提供和跟踪医疗器械的精确方向和位置。由于传感器的尺寸小，医疗器械可以将传感器结合到医疗器械的内部或外部，以便于连续导航。尽管将根据具体示例性实施方案来描述本公开的内容，但是对本领域的技术人员而言显而易见的是，可以在不脱离本公开的实质的情况下进行各种修改、重新布置和替换。本公开的范围由所附权利要求限定。
图1示出了用于识别医疗器械在电磁场中的位置的系统和方法的一个示例性实施方案。具体地讲，示出了被配置成利用CT、MRI或荧光镜图像的电磁导航(EMN)系统100。一个这种EMN系统可以是由Covidien LP公司出售的电磁导航系统。EMN系统100包括导管引导组件110、支气管镜115、计算设备120、监测设备130、EM板140、跟踪设备160和参考传感器170。支气管镜115通过有线连接(如图1所示)或无线连接(未示出)操作地联接到计算设备120和监测设备130上。
图2A示出了图1的导管引导组件110的一个实施方案。导管引导组件 110包括能够使导管引导组件110的远侧端部250推进和转向的控制手柄 210。如图2B所示，导管引导组件110包括插入EWC 230中的可定位引导导管(LG)220和电磁(EM)传感器260。锁定机构225将EWC 230和LG 220 彼此固定。可用于本公开的导管引导组件目前可以由Covidien LP公司以名称Procedure Kits和EDGETMProcedure Kits进行销售和出售。对于导管引导组件的更详细描述，可参考Ladtkow等人于2013年 3月15日提交的共同拥有的美国专利申请13/836,203以及美国专利 7,233,820，其全部内容以引用方式并入本公开。如下文将更详细描述的，LG 220的远侧部分上的EM传感器260感测电磁场，并且用于识别LG 220 在电磁场中的位置。在实施方案中，EM传感器260可直接集成到EWC 230的远侧端部中。
在使用中，将支气管镜115插入口中或通过患者150的切口插入以捕获内脏器官的图像。在EMN系统100中，插入支气管镜115中的是用于实现进入患者150的内脏器官的导管引导组件110。导管引导组件110可以包括延伸的工作通道(EWC)230，其中插入有在远侧部分处具有EM传感器 260的可定位引导导管(LG)220。如下文更详细描述的，EWC 230、LG 220和EM传感器260用于导航穿过内脏器官。
在另选的实施方案中，代替通过自然孔口插入的支气管镜115，导管引导组件110经由切口插入患者150中。包括EWC 230的导管引导组件 110可插入穿过切口以导航除肺的气道之外的腔网络，诸如心脏腔网络。
计算设备120(诸如膝上型计算机、台式计算机、平板电脑或其他类似的计算设备)包括显示器122、一个或多个处理器124、存储器126、网卡128和输入设备129。EMN系统100还可以包括多个计算设备，其中单独的计算设备用于以适于医疗操作的方式辅助临床医生的规划、治疗、可视化和其他方面。显示器122可以是触敏和/或语音激活的，使得显示器 122同时用作输入设备和输出设备。显示器122可以显示内脏器官(诸如肺、前列腺、肾、结肠、肝脏等)的二维(2D)图像或三维(3D)模型来定位和识别内脏器官的显示出疾病症状的部分。
显示器122还可以显示用于选择、添加和移除待治疗目标的选项以及用于内脏器官可视化的可设定项目。在一个方面，显示器122还可以基于内脏器官的2D图像或3D模型显示导管引导组件110在电磁场中的位置。
一个或多个处理器124执行计算机可执行指令。处理器124可以执行图像处理功能以使内脏器官的3D模型可在显示器122上显示。在实施方案中，计算设备120还可包括仅执行图像处理功能的单独的图形加速器(未示出)，以使一个或多个处理器124可用于其他程序。存储器126存储数据和程序。例如，数据可以是3D模型的图像数据或任何其他相关数据，诸如患者的病历、药方和/或患者的病史。
存储在存储器126中的一种类型的程序是3D模型和通路规划软件模块 (规划软件)。3D模型生成和通路规划软件的一个示例可以是由Covidien LP公司出售的规划套件。当从例如CT图像数据集(或由其他成像模态生成的图像数据集)将通常为数字成像和医学通信(DICOM)格式的患者的图像数据导入规划软件时，即生成内脏的3D模型。在一个方面，成像可通过CT成像、核磁共振成像(MRI)、功能性MRI、X射线和/或任何其他成像模态来完成。为了生成3D模型，规划软件采用分割、面绘制和/或体积绘制。然后规划软件允许将3D模型切片或操纵成许多不同的视图，包括通常用于查看原始图像数据的轴向、冠状和矢状视图。这些不同视图允许用户查看全部的图像数据和识别图像中的潜在目标。
一旦识别出目标，则软件进入通路规划模块。通路规划模块开发出通路规划以实现对目标的访问，并且通路规划指定该位置并标识目标的坐标，使得它们可使用EMN系统100以及尤其是导管引导组件110连同 EWC 230、LG 220和EM传感器260到达。通路规划模块引导临床医生通过一系列步骤来制定用于导出的通路规划，并且随后在导航到患者150中的目标的过程中使用。术语“临床医生”可包括医生、外科医生、护士、医疗助理或者参与规划、执行、监测和/或监督医疗过程的通路规划模块的任何用户。
这些过程和通路规划模块的细节可见于由Covidien LP公司于2013年 6月21日提交的名称为“Pathway Planning System and Method”的美国专利申请13/838,805，其全部内容以引用方式并入本公开。这种通路规划模块允许临床医生查看CT图像数据集的单个部分并且识别一个或多个目标。这些目标可以是例如病变或影响组织功能的神经的位置，在这些部位疾病已经使内脏器官的功能受损。
存储器126可以存储与EMN系统100交互的导航和程序软件，以向临床医生提供指导以及提供3D模型和由3D模型导出的2D图像上的规划通路的表示。这种导航软件的一个示例是由Covidien LP公司出售的导航和程序套件。实际上，患者150在由EM场生成设备145生成的EM场中的位置必须配准到3D模型和由3D模型导出的2D图像上。这种配准可以是手动的或自动的，并且在共同转让的名称为“System and method for navigatingwithin the lung”的美国临时专利申请62/020,240中有详细描述。
如图1所示，EM板140被配置成为患者躺下提供平坦表面并且包括 EM场生成设备145。当患者150躺在EM板140上时，EM场生成设备145 生成足以围绕患者150的一部分的EM场。LG 220端部上的EM传感器 260用于确定患者体内LG 220的远侧端部以及由此EWC 230的位置。在一个方面，单独的EM传感器可以位于EWC 230的远侧端部，并且由此可以在患者150内识别EWC 230在EM场生成设备145所产生的EM场中的确切位置。
在又一方面，EM板140可以被配置成操作地联接位于患者150的胸部上的参考传感器170。当患者150吸气时，参考传感器170随胸部向上运动，当患者150呼气时随胸部向下运动。在EM场中患者150的胸部运动被参考传感器170捕获并传送到跟踪设备160，以便可以识别患者150的呼吸模式。跟踪设备160还接收EM传感器260的输出、组合两个输出，并且补偿用于EM传感器260定位的呼吸模式。以这种方式，由EM传感器 260识别的位置可以被补偿，使得EM传感器260的补偿位置可以与内脏器官的3D模型同步。然而，如上所述，使用在其远侧端部250处具有EM传感器260的LG 230会导致位置信息围绕器械互换、丢失以及手术所需时间的普遍延长等挑战。为缓解这些问题，图3A示出了线圈形状的电磁传感器 310。传感器310可以直接印刷在医疗器械300的远侧部分上。如图所示或者在本申请所要求的另一种构造中，印刷式电磁传感器(PES)310可形成螺旋形。器械300可以是EWC 230、导管、活检器械、消融器械、单极或双极电外科器械、成像器械、标记器械或针，简而言之，即任何能够插入腔网络(例如，患者的气道或脉管系统)的器械。在一个实施方案中，器械 300的尺寸被设计为穿过EWC 230。或者，如下文所详述，器械300可以是EWC 230。其他示例性器械示于图3B至图3E中，其中示出了各自具有通过本公开的方法施加的EM传感器310的活检钳370、活检刷375、活检针380和微波消融探头385。
如下文将更详细描述的，器械300的远侧部分可以由乙烯四氟乙烯 (ETFE)、聚四氟乙烯(PTFE)、聚酰亚胺或另一合适的材料制成或由其覆盖以形成传感器310的非导电基底。如果器械300的远侧部分未被非导电材料覆盖或不由其制成，则首先必须将非导电材料涂覆到远侧部分上以形成传感器310的绝缘基底。
就图3A所示的传感器310而言，传感器310的线圈呈螺旋形。可以选择螺旋的尺寸(即，长度L、两个相邻环之间的距离d和螺旋的直径D，如图3A所示)以产生最佳的传感器310。节距角α可用于限定螺旋并且可以通过下式来计算：
节距角α表示沿着器械300的纵向轴线的印刷螺旋的环的密度。
在实施方案中，传感器310可以包括多个层。具体地讲，在将导电材料施加到器械300上以形成传感器310的第一线圈之后，可在该第一线圈上施加非导电材料，并且可以将由导电材料形成的第二线圈施加到器械300 上的所述非导电材料和所述第一线圈上。这可以继续，直到在器械300上制成或印刷上期望数量的线圈。每个线圈可以具有不同的构造，例如，不同的取向、不同的长度L以及与其他线圈不同的螺旋的两个相邻环之间的距离d。或者，传感器310的多个线圈中的每一者可以施加到器械300的不同位置。在实施方案中，每个线圈可彼此基本正交。
在本公开的一个方面，一个线圈的螺旋的旋转方向可以与另一个线圈的旋转方向不同。也就是说，一个螺旋可以具有逆时针方向，另一个螺旋可以具有顺时针方向。在另一方面，导电材料可为铜、银、金、导电合金或导电聚合物，非导电材料可以是ETFE、PTFE、非导电聚合物或聚酰亚胺。
根据本公开的另外的方面，螺旋310的每个端部可以具有比螺旋中的导电材料的其他区域更大的面积以用于电触件320和330。线连接至触件 320和330中的每一者。这些线可延伸导管组件100的长度并且可以连接至跟踪设备160。如下文所详述，在另一个实施方案中，通过将导电材料直接印刷在器械300上以将传感器310耦接到跟踪设备160，从而将线集成到器械300上。因此，当器械300位于电磁场内时，在器械300在电磁场内运动时传感器310中可感应到电信号(例如，电压)。感应的电信号被传输至跟踪设备160，该跟踪设备计算器械300相对于电磁场的坐标系的位置。该计算的位置可以被配准到3D模型上，使得计算设备可在显示器上显示在 3D模型中的该位置。以这种方式，临床医生可以如上所述识别器械300在 3D模型以及导航和程序软件的2D图像中的相对位置。
感应的电压由麦克斯韦方程得出并且由下式计算：
其中Ɛind 为感应的电压 ，N是螺旋中环的数量，ΔΦ为电磁场的磁通量变化，并且Δt是时间的变化。磁通量Φ是磁场量值和面积的乘积。以同样的方式，磁通量的变化ΔΦ是磁场量值的变化和螺旋中一个环的面积的乘积。因此，螺旋中环越多，感应电压的量值越大。并且磁通量的变化越快，感应电压的量值越高。负号表示产生感应电压以对抗磁通量的变化。
由于器械300通常在身体内部或内脏器官的腔网络中缓慢且小心地移动，以及螺旋中环的尺寸应该尽可能小，所以螺旋中环的数量可以足够大以补偿缓慢运动和环的尺寸以便具有可识别的感应电信号。因此，当确定感应电信号的灵敏度水平和电磁场的量值水平时，线圈传感器310中环的数量可以由下式确定：
传感器310可以感测由EM场生成设备145生成的不同EM场，在采用三个线圈的实施方案中，在传感器310中感测到三个独立的场。EM场的强度随着与源(例如，EM场生成设备145)的距离的平方的倒数成比例地减小。因此，由EM场感应的电压的量值包括限定传感器310距EM场生成设备145的距离的信息。通过基于感应的电信号确定距离信息，可以相对于EM场生成设备145的位置来识别传感器310的位置。
在一个方面，在EM场生成设备145生成三个EM场(其可以分别具有三个不同的方向性模式，例如x轴、y轴和z轴)的情况下，当具有传感器310的器械300在EM场的坐标系内沿任何方向移动时，感应的电信号可以具有不同的模式。例如，当器械300在x轴方向上移动时，与具有x 轴方向性的EM场的感测到的强度变化相比，具有y轴和z轴方向性模式的 EM场的强度将显示出更大的差异。因此，可以通过检查由传感器310感测到的感应电压的模式来识别器械300的位置。
根据本公开，传感器310可以被直接印刷在器械300上。也就是说，在器械300的制造期间，处理步骤之一是将一种或多种导电油墨或其他材料施加到器械300上。在不脱离本公开的范围的情况下，该印刷可以通过包括喷墨印刷、柔性版印刷、气相沉积、蚀刻以及本领域技术人员已知的其他处理的多种处理来执行。
图4示出了印刷在器械450(诸如医疗器械)的表面上的传感器410, 420。传感器400可以具有约0.01毫米至0.05毫米(mm)的厚度，使得传感器可以被印刷在器械上而不明显增加器械的尺寸。根据一个实施方案，导电材料415直接印刷在器械300上以形成线圈410或420，并且第二非导电膜430覆盖该导电材料。因此，线圈410或420受到非导电膜430的保护。
如上所述，在本公开的一个方面，每个线圈可以具有不同的旋转取向。第一线圈410可以具有顺时针旋转取向，并且第二线圈420可以具有逆时针旋转取向。然而，当传感器400被直接印刷在器械450上以使得两个线圈在管的纵向轴线上面向彼此时，第一线圈和第二线圈410和420可以具有相同的旋转取向。
图5示出了根据本公开的实施方案的双层电路传感器500。尽管未示出，但可以想象，双层电路传感器500直接印刷在器械上。双层电路传感器500包括第一线圈510、第二线圈520、第三线圈530和第四线圈540。顶层包括第一线圈和第二线圈510和520，并且底层包括第三线圈和第四线圈530和540。双层电路传感器500还包括第一触件和第二触件550和560 以及第一通孔、第二通孔、第三通孔和第四通孔512,514,522和524。
在本公开的一个非限制性示例中，线圈510-540中的任一者的每个环的导电材料可以是大约9微米厚。导电材料的厚度可以基于电路传感器500 的规格而变化，并且在不脱离本公开的范围的情况下对于特定应用可大于或小于9微米。根据本公开的一个实施方案，顶层和底层的线圈510-540的每个环分别可以彼此分开大约0.009英寸。每个线圈的最外环的长度和宽度可分别为大约0.146英寸和大约0.085英寸。导电材料的宽度可以是大约0.001英寸或约0.025mm至0.5mm。通孔可以具有大约0.002英寸的直径。电路传感器500的厚度可以是大约0.005英寸或大约0.01mm至0.15mm。电路传感器500的长度和宽度可分别为大约0.180英寸和大约0.188英寸。同一线圈的最近环之间的间隙通常可以是约0.0005英寸。
如图5所示，第一触件550连接至第一线圈510的一端，并且第一通孔512连接至第一线圈510的另一端。第一通孔512将顶层的第一线圈510 连接至底层的第四线圈540的一端。第四线圈540的另一端通过第四通孔 524连接至顶层的第二线圈520的一端。第二线圈520的另一端通过第三通孔522连接至底层的第三线圈530的一端。第三线圈530的另一端通过第二通孔514连接至顶层上的触件560。以这种方式，四个线圈510,520,530 和540全部连接至第一触件和第二触件550和560，从而形成具有四个线圈串联电连接的传感器。由于四个线圈全部相互连接，并且传感器中环的数量是四个线圈510,520,530和540的环的总和，结果就是电磁场的灵敏度增加。
根据本公开的又一方面，第一线圈和第二线圈510和520可以具有不同的旋转取向，同样地，第三线圈和第四线圈530和540可以具有不同的旋转取向。也就是说，如果第一线圈510具有逆时针取向，则第二线圈520 具有顺时针取向。同样，如果第三线圈530具有逆时针取向，则第四线圈 540具有顺时针取向。在另一方面，第一线圈和第四线圈510和540可以具有相同的旋转取向，并且第二线圈和第三线圈520和530可以具有相同的旋转取向。
如图5所示，第一触件和第二触件550和560被制成大于线圈的每个环的宽度。一般来讲，电路传感器500的每个线圈被非导电材料包覆。在一个方面中，第一触件和第二触件550和560可以不被非导电材料覆盖，使得多层电路传感器500可以容易地连接至线，该线将感应的电信号(例如，电压和/或电流)传输到外部装置(诸如跟踪设备160)用于结合到上述导航和程序软件中并与其一起使用。
图6A至图6C示出了直接印刷在器械或EWC 600上的多层电路传感器的示例性实施方案。图6A和图6B示出了第一层印刷式电路传感器和第二层印刷式电路传感器601,602。每个层可包含一个或更多个印刷式传感器。图6C示出了EWC 600的不同层。如图6A所示，第一层包含第一传感器和第二传感器610,620，并且第二层(如图6B所示)包含第三传感器 630。尽管单独示出，但可以设想，第二层(如图6B所示)印刷在第一层 (如图6A所示)的顶部上。仅出于方便目的，在图6A和图6B中以简化的示意性方式仅示出了每个线圈的环中的一对环，但是，图6中的每个环可以表示多个环，并且环的数量可以更加匹配图5的线圈510-540的环的数量。传感器610,620,630被印刷在EWC 600的远侧部分上。图6C示出了印刷在EWC600的近侧部分上的不同的导电层和不同的非导电层。导电层和非导电层通过末端或通孔612,614,622,624,632,634耦接到第一传感器、第二传感器和第三传感器610,620,630的端部，并将传感器电连接到跟踪设备160。
如前所述，传感器610,620,630是分层印刷的。具体地讲，包含第一传感器和第二传感器610,620的第一层直接印刷在EWC 600的非导电层上。然后在第一传感器和第二传感器610,620的顶部上印刷第二非导电层。然后将包含第三传感器630的第二层印刷在第二非导电层的顶部上。该过程可以继续，直到在EWC 600上印刷上期望数量的传感器。在一个方面，最终层是非导电层。在又一方面，导电材料可以是铜、银、金、导电合金或导电聚合物，非导电材料可以是Kapton、ETFE、PTFE、非导电聚合物或聚酰亚胺。每个传感器可以具有不同的构造或取向，例如不同的长度L以及与其他线圈不同的螺旋的两个相邻环之间的距离d。
如图6A和图6B所示，每个传感器610,620,630包含连接至每个传感器610,620,630的末端的通孔612,614,622,624,632,634。具体地讲，传感器610包含第一通孔和第二通孔612,614，传感器620包含第三通孔和第四通孔622,624，并且传感器630包含通孔632,634。在实施方案中，每个通孔被电耦接至EWC 600的近侧部分上的不同导电层，如图6C中更详细地示出。
图6C示出了EWC 600和直接印刷在器械上的各种导电和非导电材料层的实施方案。图6C不是按比例绘制的，并且仅用于示例性目的。导电材料和非导电材料的每一层的厚度可以在9微米到0.05毫米(mm)的范围内。
EWC 600包括由内部Teflon内衬(例如，PTFE)组成的中空管。 Teflon内衬提供用于轻松地将工具沿EWC 600的中心向下滑动的润滑性。在一个实施方案中，第一传感器、第二传感器和第三传感器610,620,630 直接印刷在Teflon层上。上述Teflon层是线交织层(未示出)。线交织层有助于提供结构完整性和可扭转性，以便于EWC 600的可操纵性。最终层是热塑性层，该热塑性层通过热处理将所有三层结合在一起以提供耐久性。
如上所述，第一传感器、第二传感器和第三传感器610,620,630印刷在EWC 600远侧部分的Teflon层上。在EWC 600的近侧部分，非导电层 640和导电层613,615,623,625,633,635以交替的方式直接印刷在Teflon层上。换句话讲，在Teflon层的顶部上印刷基底非导电层640，随后在该基底非导电层的顶部上印刷导电层613。然后在导电层613的顶部上印刷另一非导电层，并且在该非导电层的顶部上印刷另一导电层615。然后重复这一过程，直至获得期望数量的非导电层和导电层。在实施方案中，最终层为非导电层。然后将线交织层和热塑性层设置在最终的非导电层的顶部。图 6C所示的实施方案示出了总共六个导电层613,615,623,625,633,635和七个非导电性层640。在一些方面，该导电材料可以是铜、银、金、导电合金或导电聚合物，并且非导电材料可以是Kapton、ETFE、PTFE、非导电聚合物或聚酰亚胺。
导电层用作导线并且形成用于传感器610,620,630的返回路径，从而将传感器连接至跟踪设备160。例如，在一个实施方案中，导电层613连接至通孔612，导电层615连接至通孔614，导电层623连接至通孔622，导电层625连接至通孔624，导电层633连接至通孔632，并且导电层635连接至通孔634。
由于传感器610,620,630非常薄，所以传感器610,620,630具有高电阻，然而，对于返回路径期望具有低电阻。在一个实施方案中，每个导电层613,615,623,625,633,635围绕EWC 600以360度的角度印刷并沿着 EWC 600的长度返回近侧端部，以减小返回路径上的电阻。
所测得的传感器610,620,630和导电层613,615,623,625,633,635的电阻率是许多因素的函数，包括所使用的导电材料的长度、宽度和厚度以及电阻特性。在一个实验中，由200匝具有1.68×10-5Ωmm电阻的导电材料制成并且围绕具有1256mm长度、0.47mm宽度、0.01mm厚度的EWC 600 的远侧端部印刷的传感器测得的总电阻为179.58Ω。同样，由300匝导电材料制成并且围绕具有1884mm长度、0.015mm厚度的EWC 600的远侧端部印刷的传感器测得的总电阻为269.37Ω。在实验中，由相同的导电材料制成、沿着具有1020mm长度、6.28mm周长的EWC 600的长度印刷的返回路径测得的电阻为10.92Ω。导电返回路径的低电阻率有助于降低从传感器 610,620,630返回到跟踪设备160的信号中的噪声量。
如上所述，将传感器施加到器械的一种方法是直接印刷在器械上。图 7示出了将导电材料和非导电材料直接印刷在器械的期望位置上的印刷装置 700。印刷装置700包括贮液器710、印刷喷嘴720和致动臂730。贮液器 710包括容纳导电材料的第一槽740和容纳非导电材料的第二槽750。印刷喷嘴700可以在可被锁定到致动臂730的远侧端部上的任何器械760上印刷电路。在一个方面，印刷装置可以在聚合物上印刷传感器。
印刷装置700的控制器(在图7中未示出)控制致动马达(在图7中未示出)以移动致动臂730。致动马达固定地连接至致动臂730的近侧端部。致动马达可以向前和向后分度并且转动致动臂730。在一个方面中，致动马达可以在印刷时移动贮液器710。在另一方面，致动马达可同时移动贮液器710和致动臂730。例如，致动马达可以在使致动臂730旋转时向前或向后分度贮液器710。更进一步地，储液器710和器械760可以保持静止，而流体地连接至储液器710的印刷喷嘴720围绕器械760移动。此外，在不脱离本公开的范围的情况下，本领域技术人员可以采用这些技术的组合。
在一个实施方案中，在器械760的近侧端部锁定到致动臂730的远侧端部上的情况下，印刷喷嘴720可以开始印刷容纳在第一槽740中的导电材料，同时致动臂730受致动马达驱使向前移动并旋转。控制分度和旋转的速度以在器械760上印刷螺旋型传感器770。当分度的速度比旋转的速度快时，螺旋型传感器770将具有大的节距角或在螺旋中具有松散的环。另一方面，当分度的速度(分度速度)比旋转速度(角速度)慢时，螺旋型传感器770将具有小的节距角或在螺旋中具有密集的环。节距角和速度之间的关系如下所示：
其中α是节距角，νi是分度速度，νθ是以弧度表示的旋转角速度，D是器械 760的横截面直径。因此，控制器可以控制分度速度νi和角速度νθ，使得印刷电路770可以具有适用于其目的的节距角。
在一个方面，印刷可以从器械760的远侧端部或器械760的近侧端部开始。在从器械760的远侧端部开始印刷的情况下，致动臂730使器械760 向前分度，使得印刷喷嘴720可朝器械760的近侧端部印刷导电材料。在从器械760的近侧端部开始印刷的另一情况下，致动臂730使器械760向后分度，使得印刷喷嘴720可朝向器械760的远侧端部印刷导电材料。在另一方面，致动臂730可改变旋转方向，使得螺旋型传感器770可具有逆时针或顺时针方向的螺旋。
印刷喷嘴720可以在印刷的开始和结束时印刷更多的导电材料，使得螺旋型传感器770的每个端部具有更大的面积以用于与外部装置接触。在另一方面，在印刷螺旋型传感器770的一层之后，致动臂730可以执行反向分度和旋转运动，这意味着当在印刷螺旋型传感器770时执行的是向前分度时执行向后分度，并且当在印刷螺旋型传感器770时执行的是顺时针旋转时执行逆时针旋转。同时，印刷喷嘴720可以在所印刷的导电材料上印刷非导电材料。以这种方式，所印刷的导电材料可以被非导电材料完全覆盖。可以控制印刷喷嘴720以在比所印刷的导电材料的区域更大的区域上印刷非导电材料。这可以更加确保所印刷的导电材料被非导电材料完全覆盖。
在完成印刷非导电材料之后，印刷喷嘴720可以再次在器械760上印刷导电材料。在一个方面，可以选择不同于原始分度速度νi和角速度vθ的新的分度速度νi’和新的角速度νθ’，使得新的螺旋型传感器可以具有不同于原始螺旋型传感器的构造。通过重复这些步骤，器械760可具有多个螺旋型传感器。
在又一方面，致动臂730可以控制向前和向后分度以及旋转运动，使得传感器可以具有不同的构造。例如，传感器可具有一系列不完整的圆形。这种图案可以通过转动驱动臂而不向前分度然后在完成一整圈之前通过向前分度而不转动来获得。本公开的范围可以延伸到本领域普通技术人员可容易理解的相似或不同的构造。
图8示出了使用印刷机在表面上印刷传感器的方法800。该传感器可以是单层的或多层的。方法800从将步骤810的计数N设置为零开始。在步骤820中，印刷机印刷用于外部装置的触件的导电材料。接触区域可以大于传感器的所印刷的导电材料的区域。在步骤830中，印刷机在管上印刷导电材料。在印刷时，在步骤840中，保持管的印刷机的分度臂向前或向后分度，并且使该管旋转。此时可以控制分度臂的分度速度和角速度，以形成如上文在图7中所述的传感器的特定图案。
在步骤850中，印刷机印刷用于另一触件的导电材料。在步骤810和步骤850中印刷的触件将用于连接至线，该线通向并且连接至诸如图1的跟踪设备160的外部装置。如上所述，跟踪设备可以处理感测到的结果以识别传感器在电磁场中的位置。
在步骤860中，印刷机印刷非导电材料以在所印刷的导电材料上形成非导电膜。在印刷非导电材料时，在步骤870中，印刷机的致动臂向前或向后分度，并且沿着与印刷导电材料的方向相反的方向转动。以这种方式，印刷的导电材料与其他环境绝缘或受到保护。该步骤结束传感器的印刷。
在步骤880中，计数N增加1。在步骤890中，将计数N与预定的层数进行比较。如果计数N小于预定的层数，方法800重复步骤820至 890。如果计数N不小于预定的层数，该方法结束。
在一个方面，当预定的层数大于1时，印刷在每层中的传感器可具有不同的构造，诸如如图7所示的螺旋图案和节距角。或者，多个层中的传感器可以全部连接，使得传感器仅具有两个触件，而不是每层中的传感器具有与另一个传感器的两个触件分开的两个触件。
尽管出于举例说明和描述的目的已经参照附图详细描述了实施方案，但是应当理解，本发明的过程和装置不应当被解释为限制性的。对本领域的普通技术人员而言将显而易见的是，在不脱离本公开的范围的情况下，可以对前述实施方案进行各种修改。

Claims (15)

1.一种具有远侧部分和近侧部分的医疗器械，所述医疗器械包括：
传感器，所述传感器印刷在所述医疗器械的远侧部分上并且具有由导电材料形成的至少一个线圈；
至少一种非导电覆盖材料，所述至少一种非导电覆盖材料覆盖所述传感器的所述至少一个线圈；
近侧导电层，所述近侧导电层周向围绕所述医疗器械的所述近侧部分印刷；
非导电层，所述非导电层印刷在所述近侧导电层的顶部上；和
至少一对触件，所述至少一对触件电连接至所述至少一个线圈并且耦接至所述近侧导电层，所述近侧导电层能够连接至测量设备，所述测量设备被配置成基于电磁场的磁通量变化来感测感应的电信号，
其中基于所述传感器中的所述感应的电信号来识别所述医疗器械在所述电磁场的坐标系中的位置。
2.根据权利要求1所述的医疗器械，还包括在所述医疗器械的所述远侧部分上的基底非导电层，所述传感器的所述导电材料印刷在所述基底非导电层上。
3.根据权利要求2所述的医疗器械，其中在所述医疗器械的所述远侧部分上印刷或制造多个层，所述多个层中的每一个均包括所述传感器和所述非导电覆盖材料。
4.根据权利要求3所述的医疗器械，其中，所述多个层中的传感器具有不同的构造。
5.根据权利要求4所述的医疗器械，其中所述不同的构造包括所述传感器的不同的节距角和不同数量的导电材料环。
6.根据权利要求3所述的医疗器械，其中所述医疗器械的所述近侧部分包括印刷在所述医疗器械的所述近侧部分上的多个所述近侧导电层和多个所述非导电层。
7.根据权利要求6所述的医疗器械，其中每个所述近侧导电层相应地耦接到每个所述传感器的所述导电材料。
8.根据权利要求7所述的医疗器械，其中每个所述传感器的所述导电材料通过通孔连接至每个所述近侧导电层。
9.根据权利要求1所述的医疗器械，其中所述传感器的所述导电材料形成螺旋形。
10.根据权利要求9所述的医疗器械，其中所述螺旋形为逆时针方向。
11.根据权利要求9所述的医疗器械，其中所述螺旋形为顺时针方向。
12.根据权利要求1所述的医疗器械，其中所述医疗器械的外表面由非导电聚合物制成。
13.根据权利要求1所述的医疗器械，其中所述医疗器械的外表面由ETFE、PTFE或聚酰亚胺制成。
14.根据权利要求1所述的医疗器械，其中所述传感器的所述导电材料为铜、银、金、导电合金或导电聚合物。
15.根据权利要求1所述的医疗器械，其中所述医疗器械为延伸的工作通道、成像器械、活检钳、活检刷、活检针或微波消融探头。
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AU2016270295B2 (en) 2020-02-27
EP3302220A1 (en) 2018-04-11
CA2986608A1 (en) 2016-12-08
EP3302220B1 (en) 2021-07-14
US10426555B2 (en) 2019-10-01
WO2016196010A1 (en) 2016-12-08
AU2016270295A1 (en) 2017-11-30
US20160354160A1 (en) 2016-12-08
CN107613836A (zh) 2018-01-19
JP2018521727A (ja) 2018-08-09
EP3302220A4 (en) 2019-03-27

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