CN118043006A - 机器人介入装置的无菌包装组件 - Google Patents

机器人介入装置的无菌包装组件 Download PDF

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CN118043006A
CN118043006A CN202280066721.5A CN202280066721A CN118043006A CN 118043006 A CN118043006 A CN 118043006A CN 202280066721 A CN202280066721 A CN 202280066721A CN 118043006 A CN118043006 A CN 118043006A
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sterile
hub
packaging assembly
catheter
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利利普·劳
阿尔伯特·哈里斯
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Abstract

用于将介入装置运输至机器人手术部位的无菌包装组件包括具有轮毂支撑部分并被配置为封闭无菌体积的无菌屏障;以及所述无菌体积内的至少第一介入装置。所述第一介入装置包括轮毂和细长柔性体。所述轮毂包括至少一个磁体和被配置为在所述无菌屏障的所述轮毂支撑部分上滚动的至少一个辊。

Description

机器人介入装置的无菌包装组件
相关申请的交叉引用
本申请要求2021年11月16日提交的美国专利申请第17/527,460号和2021年8月12日提交的美国临时申请第63/232,444号的优先权,这些申请的全部内容在此通过引用并入本文。
背景技术
多种神经血管手术可以经由经血管通路完成,包括血栓切除术、诊断性血管造影术、栓塞线圈部署和支架放置。然而,神经血管护理的递送受到各种挑战的限制或延迟。例如,没有足够的经训练的介入医生和中心来满足当前对神经介入的需求。神经介入是困难的,具有复杂的设置要求和对外科医生灵巧性的要求。外科医生必须用双手对3-4个同轴导管进行精确控制,并管理荧光透视系统和患者位置。长而曲折的解剖结构,需要精细、精确的操作。由于同轴的轴和患者脉管系统之间的摩擦相互作用,可能会发生导管意外运动。实现到达神经血管所需的主动脉上通路具有挑战性,尤其是III型弓。
因此,仍然需要一种主动脉上通路系统来解决这些挑战中的一些或全部,并增加神经血管手术的可用性。优选地,该系统额外地能够通过主动脉上通路进一步向远侧驱动装置,以完成颅内血管中的手术。
发明内容
根据本发明的一个方面,提供了一种主动脉上通路机器人控制系统。该系统包括导丝轮毂,其被配置为调节导丝的轴向位置和旋转位置中的每一个;引导导管轮毂,其被配置为在轴向方向上调节引导导管;以及通路导管轮毂,其被配置为调节通路导管的轴向位置和旋转位置中的每一个,并且还横向偏转通路导管的远端偏转区。导丝轮毂还可被配置为横向偏转导丝的远端部分。
还可以提供被配置为操纵手术导管的手术导管轮毂。在机器人放置导丝、通路导管和引导导管使得引导导管实现主动脉上通路之后,导丝和通路导管可以从近端抽出,并且推进手术导管通过并超过引导导管以到达神经血管治疗部位。手术导管可以是抽吸导管;栓塞部署导管;支架部署导管;分流器部署导管、通路导管;诊断性血管造影导管;引导导管、成像导管、生理传感/测量导管、输注或注射导管、球囊导管或支架取回器。
控制系统还可包括导丝轮毂、通路导管轮毂和引导导管轮毂中的每一个上的从动磁体,所述从动磁体被配置为与相应的驱动磁体配合,使得从动磁体响应相应驱动磁体的运动而运动。驱动磁体可以各自独立地由支撑台轴向可移动地承载。驱动磁体可以位于无菌区外,通过屏障与从动磁体间隔开,而从动磁体可以在无菌区内。屏障可以包括由薄聚合物膜或任何非铁磁材料膜制成的托盘。
控制系统还可以包括控制台,所述控制台可以连接至支撑台,或者可以位于远离支撑台的位置。每个从动磁体和相应轮毂(hub)的位置可响应于控制台上的导丝驱动控制器、通路导管驱动控制器或手术导管驱动控制器的手动操作而移动。
控制系统可进一步包括用于控制驱动磁体位置的处理器。处理器可以与控制台进行有线通信,或者与控制台进行无线通信。从动磁体可被配置为保持与相应的驱动磁体接合,直到施加至少约300克的破坏力。
还提供了机器人驱动的介入装置。装置包括细长的柔性体,所述细长的柔性体具有近端和远端。轮毂设置在近端上。至少一个可旋转辊设置在轮毂的第一表面上;并且至少一个磁体设置在轮毂的第一表面上。辊可以延伸得比磁体更远离第一表面。轮毂还可以设置有至少第二辊。
导丝轮毂、通路导管轮毂和手术导管轮毂中的任一个都可以进一步配备旋转驱动器,用于使相应的介入装置相对于轮毂旋转。轮毂还可以设置有轴向驱动机构,以向远端推进或向近端缩回轴向延伸穿过介入装置的控制元件,以调节介入装置的诸如形状或柔性的特性。控制元件可以是轴向可移动的管状体或线,例如延伸穿过介入装置到例如远端偏转区的牵引线。
还提供了一种用于控制介入装置移动的控制系统。在一种配置中,控制系统包括:导丝控制器,其被配置为控制导丝的轴向行进和旋转;通路导管控制器,其被配置为控制通路导管的轴向和旋转运动;以及引导导管控制器,其被配置为控制引导导管的轴向运动。
控制系统还可以包括偏转控制器,其被配置为控制通路导管的偏转,并可被配置用于与机器人导管驱动系统进行有线或无线通信。
控制系统可被配置为以多种模式独立地控制三个或更多个轮毂。例如,两个或更多个轮毂可以选择性地组合在一起,使得它们同时以相同的动作驱动各自的装置。另外,控制系统也可配置为同时驱动各自的装置,但以不同的动作进行驱动。
控制系统还可包括用于操作控制系统的医生界面。医生界面可以由具有机器人介入装置驱动系统的支撑台承载。可选地,用于操作控制系统的医生界面可被承载在便携式手持装置或台式计算机上,并可位于与患者相同的房间、与患者相同的设施或远程设施中。
控制系统还可包括图形用户界面,所述图形用户界面具有至少一个显示器,用于指示至少一个装置参数的状态和/或指示至少一个患者参数的状态。
还提供了用于将介入装置运输至机器人手术部位的无菌包装组件。包装组件可以包括基座和无菌屏障,无菌屏障被配置为封闭无菌体积。可以在无菌体积内提供至少一个介入装置,该装置包括轮毂和细长柔性体。轮毂可以包括至少一个磁体和至少一个被配置为在基座上滚动的辊。
在一个实施方式中,无菌屏障可拆卸地附接到基座上,以在无菌屏障和基座之间形成封闭体积。在另一个实施方式中,无菌屏障呈管状外壳的形式,用于封闭无菌体积。管状外壳可以包围无菌体积内的基座和至少一个介入装置。
轮毂可在包装内定向,使得辊和磁铁面向基座。可选地,基座可以是具有细长中心轴的托盘的形式。托盘的上部无菌区侧可以具有用于支撑和允许一个或多个轮毂滑动的细长支撑表面。可以提供平行于中心轴延伸的至少一个和可选地两个细长托盘。至少一个轮毂和介入装置可以设置在托盘中,并且具有无菌轮毂和介入装置的无菌托盘可以定位在由无菌屏障界定的无菌体积中。
基座可以被配置为位于患者附近的支撑台上,基座的上表面位于无菌区内,基座的下表面位于无菌区外。
本文公开的任何一种轮毂还可以包括流体注射端口和/或无线RF收发器。轮毂可以包括视觉指示器,用于指示凝块的存在。视觉指示器可以包括具有透明窗口的凝块室。过滤器可以设置在凝块室中。
本文公开的任何轮毂还可以包括传感器,用于检测感兴趣的参数,例如是否存在凝块。在某些情况下,传感器可以位于柔性体上。传感器可以包括压力传感器或光学传感器。在一些实施方案中,传感器可以包括力传感器、温度传感器和/或氧气传感器中的一个或多个。在一些实施方案中,传感器可以包括光纤布拉格光栅传感器。例如,光纤布拉格光栅传感器(例如,光纤)可以局部检测应变,这可以有助于检测和/或确定所施加的力。该装置还可以包括多个传感器。多个传感器可各自包括本文公开的任何类型的传感器中的一个或多个。在一些实施方案中,多个(例如,3个或更多个)传感器(例如,光纤布拉格光栅传感器)可以分布在周边周围,以便于形状的检测和/或确定。在某些情况下,可以通过使用一个或多个传感器来检测和/或确定位置来确定设备的位置。例如,一个或多个光学编码器可以位于驱动线性运动的一个或多个马达中或附近,使得光学编码器可以确定位置。
还提供了进行神经血管手术的方法,其中第一阶段包括通过机器人实现主动脉上通路,第二阶段包括经由主动脉上通路手动地或通过机器人进行神经血管手术。方法包括以下步骤:提供具有通路导管轮毂的通路导管;将通路导管轮毂耦合至由支撑台可移动地承载的轮毂适配器;响应于轮毂适配器沿工作台的移动而驱动通路导管,直到通路导管定位成实现主动脉上通路。然后可以将通路导管和通路导管轮毂与轮毂适配器解耦;然后,具有手术导管的手术导管基座可以耦合到轮毂适配器上。
方法可以额外包括推进手术导管轮毂,以将手术导管的远端定位在神经血管治疗部位。驱动通路导管步骤可以包括通过引导导管向远端驱动通路导管。驱动通路导管步骤可以包括横向偏转通路导管的远端区域以实现主动脉上通路的步骤。
还提供了进行神经血管手术的方法,包括提供通路组件的步骤,所述通路组件包括导丝、通路导管和引导导管。通路组件可以可释放地耦合至机器人驱动系统。通路组件可以由机器人驱动系统驱动,以实现至期望点的通路,例如实现主动脉上通路。然后,可以将导丝和通路导管与通路组件解耦,将引导导管留在适当的位置。可以提供手术组件,包括至少导丝和第一手术导管。手术组件可以可释放地耦合到机器人驱动系统;并且可以使用手术组件完成神经血管手术。还可以提供第二手术导管,用于穿过第一手术导管延伸到治疗部位。
耦合通路组件步骤可以包括磁耦合导丝、通路导管和引导导管中的每一个上的轮毂,以分离相应的耦合器,所述耦合器承载由驱动台独立移动承载的相应驱动磁体。手术组件可以包括导丝、第一导管和第二导管。导丝和第一导管可以同心地定位在第二导管内。手术组件可以作为单元推进通过引导导管的长度的至少一部分,并且手术可以包括神经血管血栓切除术。
本发明的附加特征和优点在美国临时申请第63/232,44号的附录A和附录B中公开,其每个的全部内容通过引用并入本文。
附图说明
图1为根据本发明的具有成像系统、患者支撑台和机器人驱动系统的介入装置的示意性透视图。
图2为示出了具有两个自由度的导丝、具有三个自由度的通路导管和具有一个自由度的引导导管之间的同心关系的纵向横截面。
图3A为通过无菌屏障与支撑台分离的介入装置轮毂的分解示意图。
图3B至图3F示出了装运托盘形式的替代无菌屏障,该装运托盘具有一个或多个用于承载介入装置的存储通道。
图4为轮毂适配器的示意性立面横截面,轮毂适配器具有通过无菌屏障与介入装置轮毂和从动磁体分离的驱动磁体。
图5A和图5B示意性示出了三介入装置和四介入装置组件。
图6为支撑台的透视图。
图7为支撑台的电机驱动端的近视图。
图8为电机和带传动组件的正截面图。
图9为支撑台的滑轮端的近视图。
图10为带滑轮的正截面图。
图11为导管(例如图5A和5B所示的导管中的任一个)的远端部分的侧立面截面图。
图12A和12B示意性地示出了集成在导管侧壁的力传感器。
图13A和13B示意性地示出了用于测量轮毂和相应滑架之间的磁耦合处的弹力的传感器。
图14示意性示出了用于本发明的导管的双编码器扭矩传感器。
图15示出了凝块捕获和可视化装置,该装置可以集成至轮毂和/或连接至抽吸管线。
图16示意性地示出了驱动机构和从动机构之间的机械耦合的实施方案。
具体实施方式
本发明提供了一种系统,用于将引导导管从股动脉或桡动脉通路推进至主动脉弓顶部大血管之一的开口处,从而实现主动脉上通路。然后,外科医生可以接管,并经由机器人放置的引导导管将介入装置推进到脑脉管系统中。
在本发明的一些实施方式中,该系统可额外配置为通过机器人获得颅内血管通路,并执行抽吸血栓切除术或其他神经血管手术。本领域技术人员将理解,本文描述的任何实施方案的系统的功能不限于将系统应用于患者。本文所述的任何系统可用于需要各种管状体彼此相对操作的任何应用中(例如医疗或非医疗程序)。因此,应该理解的是,本文描述的任何实施方案的应用不限于医疗程序。
驱动台位于患者上方或旁边,并配置为轴向推进、缩回以及在某些情况下旋转和/或横向偏转两个或三个或更多个不同(例如同心或并排定向)的血管内装置。每个装置都具有附接到独特的轮毂上的近端,该轮毂有时被称为“圆盘(puck)”。轮毂可沿着驱动台表面的路径移动,以根据需要推进或缩回介入装置。每个轮毂还可以包含根据需要旋转或偏转装置的机构,并连接到通常连接到导管轮毂的流体输送管(未示出)上。每个轮毂经由硬线连接、RF无线连接或两者的组合与电子控制系统进行电通信。
每个轮毂可在驱动台承载的无菌场屏障膜的表面上独立移动。每个轮毂可释放地耦合到无菌场屏障工作台侧的独特驱动滑架上。在一些实施方案中,每个轮毂可以通过磁性和/或机械耦合系统可释放地耦合到独特的驱动滑架上。驱动系统独立地在近端或远端方向上移动每个轮毂穿过屏障的表面,以将相应的介入装置在患者的脉管系统内向近端或远端移动。
驱动台上与轮毂磁性和/或机械耦合以提供线性运动致动的滑架是通用的。导管/导丝的功能是根据轮毂和轴设计中包含的内容提供的。这样可以灵活地配置系统,以在同一个驱动台上使用各种介入装置进行各种手术。
图1为具有用于支撑患者14的患者支撑台12的介入装置10的示意性透视图。根据本发明,可以提供成像系统16以及机器人介入装置驱动系统18。
驱动系统18可包括支撑台20,用于支撑例如导丝轮毂26、通路导管轮毂28和引导导管轮毂30。在本文中,术语“通路”导管可以是具有空腔的任何导管,所述空腔具有至少一个面向远端或面向侧向(laterally facing)的远端开口,可用于抽吸血栓,为通过或沿其推进的附加装置提供通路,或者用于注射盐水或造影剂或治疗剂。
根据所需的临床程序,可以提供更多或更少的介入装置轮毂。多个介入装置22在支撑台20和(在所示示例中)患者14的股骨接入点24之间延伸。根据所需的程序,可以通过经皮或切开进入各种动脉或静脉中的任一种,例如股动脉或桡动脉。尽管本文主要在神经血管通路和手术的背景下进行了公开,但是机器人驱动系统和相关的介入装置可以容易地被配置为用于多种附加医疗介入中,用于外周和冠状动脉和静脉脉管系统、胃肠系统、肺部气道、经由经输尿管或尿道或输卵管导航到达的治疗部位、或身体中的其他中空器官或结构。
支撑台20和/或患者支架12可承载显示器23,例如用于查看荧光图像、导管数据(例如,光纤布拉格光栅光纤传感器数据或其他力或形状传感数据)或其他患者数据。或者,包括显示器23的医师输入/输出接口可以远离患者,例如在辐射遮挡板后面、在与患者不同的房间中或者在与患者不同的设施中。
在所示实例中,导丝轮毂26由支撑台20承载,并可沿着支撑台移动,以将导丝推进进入和离开患者14。通路导管轮毂28也由支撑台20承载,并可沿着支撑台移动以将通路导管推进进入和离开患者14。通路导管轮毂还可以被配置为响应于旋转控制器的操纵而旋转通路导管,并且还可以被配置为响应于偏转控制器的操纵而横向偏转通路导管的可偏转部分。
图2为示意性地示出了具有两个自由度(轴向和旋转)的导丝27、具有三个自由度(轴向、旋转和横向偏转)的通路导管29和具有一个自由度(轴向)的引导导管31之间的运动关系的纵向截面图。
参考图3A,支撑台20包括下文将更详细描述的驱动机构,以独立地驱动导丝轮毂26、通路导管轮毂28和引导导管轮毂30。抗屈曲特征34可以设置在近端抗屈曲区域中,用于抵抗介入装置的跨越支撑台20和股动脉接入点24之间的距离的部分的屈曲。抗屈曲特征34可以包括多个同心的可轴向伸缩延伸和收缩的管,介入装置通过所述管延伸。
或者,一个或多个装置轴的近端段可被配置为具有增强的刚度以减少压缩下的屈曲。例如,近侧加强段可从轮毂向远侧延伸至少约5cm或10cm但通常不超过约130cm或约100cm或约50cm或约30cm的距离,以将装置支撑在轮毂和患者身上的接入点24之间。加强可通过将至少一个或两个或更多个轴向延伸元件嵌入壁(例如细长线或带)中来实现。或者,薄管状加强结构可以嵌入装置壁内或承载在装置壁的外部,例如管状聚合物挤压件或一段海波管。或者,可移除的加强心轴可以放置在装置的近端段中的空腔内,并且在轮毂朝患者接入部位的向远侧推进之后向近侧移除,以防止近端轴在轮毂向远侧推进期间屈曲。或者,介入装置的壁厚或直径可以在抗屈曲区域中增加。
介入装置轮毂可通过无菌屏障32与支撑台20分离。无菌屏障32可以包括薄塑料膜,例如PET。这允许支撑台20和相关的驱动系统位于无菌屏障32的非无菌(下)侧。导丝轮毂26、通路导管轮毂28、引导导管轮毂30和相关的介入装置都在无菌屏障32的无菌(顶)侧。无菌屏障优选是防水的,并且还可以用作介入装置包装中使用的托盘,这将在以下进一步讨论。介入装置可以单独提供,或者作为同轴预组装套件提供,所述同轴预组装套件在托盘中运输和储存并封装在无菌包装中。
图3B至图3F示意性地说明了替代的无菌屏障,其为双功能无菌屏障的形式,用于在介入手术过程中放置在支撑台上,以及装运具有用于承载无菌介入装置的存储通道的一个或多个托盘。
参考图3B和图3C,示出了预成型托盘形式的无菌屏障32,用于安装在细长支撑台20上。无菌屏障32在近端100和远端102之间延伸,并包括用于支撑介入装置轮毂的上支撑表面104。在一个实施方式中,在线性驱动配置中,支撑表面104的轴向长度大于预期介入装置的长度。在线性驱动台中,支撑表面104的长度通常为至少约150cm或约180cm。在被配置为沿弧形路径推进驱动耦合器的系统中可以使用较短的长度。
可设置至少一个第一通道106,所述第一通道轴向延伸至少支撑台20的长度的一部分。在示出的实施方式中,第一通道106延伸支撑台20的整个长度。优选地,第一通道106具有足够的长度来容纳介入装置,并且具有足够的宽度和深度来容纳相应的轮毂。第一通道106界定在底板108、外侧壁110和内侧壁111内,形成朝上的凹部。任选地,可以提供第二通道112。第二通道112可以位于上支撑表面104与第一通道106的同一侧或相对侧。可以提供两个或三个或更多个额外凹槽(例如额外通道或井),以容纳在介入手术过程中可能有用的额外医疗装置或用品。
参考图3D,引导导管轮毂30被示出位于上支撑面104上,并与位于无菌屏障32下方的固定驱动磁体的相应耦合器磁性耦合。在本文所述的任何实施方案中,本领域技术人员将理解,作为磁性耦合机构的替代或除了磁性耦合机构之外,本文所述的任何轮毂可以通过无菌屏障32机械耦合到相应的耦合器。通路导管轮毂28和通路导管29以及导丝轮毂26和导丝27被示出位于第一通道106内,例如在通过引导导管31引入之前或从引导导管31移除之后。为了简化绘图,导管的长度被缩短了。
介入装置可定位在通道106内,并封装在无菌屏障中用于运输。容纳无菌介入装置的无菌屏障可以容纳在第二外部密封容器(例如膜袋)内,其可以是第二外部无菌屏障。在临床部位,无菌屏障的上面板可以被移除,或者外部管状无菌屏障包装可以被打开并从支撑台20和无菌屏障32组件轴向移除,暴露无菌屏障托盘的无菌顶侧和任何包含的介入装置。介入装置可以单独承载在通道中,或者预先组装到通路组件或手术组件中,下面将详细讨论。
图3D至图3F示出了无菌屏障放置在适当位置的支撑台,图3E示出了在将通路组件耦合至无菌屏障下方的相应滑架后,用于主动脉通路的通路组件中配置的介入装置。通路组件可以预先组装,使导丝完全推进通过通路导管,所述通路导管又完全推进通过引导导管。该通路组件可以作为单元被提升出通道106,并定位在支撑表面104上,用于耦合到相应的驱动磁体并引入患者体内。引导导管轮毂30是最远端轮毂。通路导管轮毂28定位在引导导管轮毂的近端,使通路导管29可以通过引导导管向远端延伸。导丝轮毂26位于最近端,以允许导丝27推进穿过通路导管29和引导导管31。
图3F示出了通过引导导管31引入程序组件后的手术组件,所述引导导管31用于实现主动脉上通路。在该实施方式中,引导导管31保持在介入装置的最远端。示出了第一手术导管120和相应的轮毂122延伸穿过引导导管31。示出了任选的第二手术导管124和相应的轮毂126延伸穿过第一手术导管120。在第二手术导管124的快速更换型式中,引导线27延伸穿过第二手术导管124的至少一部分,或者在线上(over the wire)实施方式中延伸穿过第二手术导管124的整个长度。
在一个商业实施中,预组装的通路组件(引导导管、通路导管和导丝)可承载在无菌屏障托盘的第一通道内,并且预组装的手术组件(一个或两个手术导管和导丝)可承载在无菌屏障托盘的相同或不同的第二通道内。根据介入手术过程中的潜在需求,还可以提供一个或两个或更多个额外导管或介入工具。
参见图4,轮毂36可代表前述轮毂的任何一种。轮毂36包括在近端40和远端42之间延伸的壳体38。介入装置44可以是本文公开的任何介入装置,从轮毂36向远端延伸并进入患者14(未示出)。轮毂适配器48或滑架通过响应操作者的指令沿着轨道向近端或远端前进而起到往复移动装置的作用。轮毂配适器48包括至少一个驱动磁体50,所述驱动磁体50被配置为与由轮毂36承载的从动磁体52耦合。这提供了驱动磁体50和从动磁体52之间穿过无菌屏障32的磁耦合,使得轮毂36和相关联的介入装置在无菌区内移动穿过无菌屏障32的顶部,以响应于轮毂适配器48在无菌区外的移动。轮毂适配器的移动由支撑台承载的驱动系统驱动,并在以下进一步详细描述。
为了减少系统中的摩擦,轮毂36可以设置有至少第一辊54和第二辊56,其可以是轮或可旋转球或鼓的形式。辊将无菌屏障32与从动磁体52的表面间隔开至少约0.008”且通常不超过约0.03”。在本发明的一些实施方式中,该间隔为约0.010”至约0.016”。驱动磁体50和从动磁体52之间的空间通常不超过约0.15”,并且在一些实施方式中不超过约0.10”,例如为约0.085”至约0.090”。如图4所示,轮毂适配器48可类似地设置有至少第一轮毂适配器辊58和第二轮毂适配器辊60,其可定位成与相应的第一辊54和第二辊56相对。
图16示出了驱动机构1650和从动机构1652之间的机械耦合机构1654。除非本文另有描述,驱动机构1650和从动机构1652可以分别与驱动磁体50和从动磁体52相同或大致相似。驱动机构1650可以是轮毂适配器(例如轮毂适配器48)的一部分或耦合至其上。从动机构1652可以是轮毂(例如轮毂36)的一部分或耦合至其上。在一些情况下,机械耦合机构1654可包括横向延伸穿过无菌屏障1632中的密封件的结构支撑件(例如,支撑杆)。当驱动机构1650和从动机构1652如本文所述推进和/或缩回时,密封件可以允许结构支撑件沿着无菌屏障1632的长度前进,同时仍保持与结构支撑件的密封以保持无菌区。例如,密封件可包括沿无菌屏障1632的榫槽(tongue and groove)闭合机构,其被配置为在结构支撑件的任一侧上闭合,同时允许结构支撑件穿过无菌屏障1632并在结构支撑件沿着无菌屏障1632的长度前进时保持对结构支撑件的密封。本领域技术人员将会理解,本文描述的任何实施方案都可以修改以结合机械耦合机构,例如如图16所示。
参照图6,示意性地示出了薄型线性驱动支撑台20的一个实例。支撑台20包括在近端52和远端54之间延伸的细长框架50。提供至少一个支撑台支撑件56以相对于患者(未示出)稳定支撑台20。支撑件56可以包括一个或多个腿或者优选地包括铰接臂,所述铰接臂被配置为允许框架50在患者上方或患者附近移动和定位。
图7示出的线性驱动台20的一个实例包括三个不同的驱动器。然而,根据期望的临床性能,可以包括两个驱动器或四个或更多个驱动器。第一驱动滑轮58接合第一驱动带60。第一滑架支架61固定至第一驱动带60,使得第一驱动滑轮58的旋转引起第一驱动带60通过细长闭环路径的旋转。根据驱动滑轮58的旋转方向,第一滑架支架61可以沿着支撑台20的纵向轴线在近端或远端方向上前进。在示出的实施方式中,驱动滑轮58设置有表面结构,例如用于接合第一驱动带60上的互补齿的多个驱动滑轮齿62。
第二驱动滑轮64可接合第二驱动带66,所述第二驱动带66被配置为沿着支撑台20上的轴向路径轴向移动第二滑架支架68。第三驱动滑轮70可被配置为驱动第三驱动带72,以沿支撑台20轴向推进第三滑架支架74。如已经讨论的,每个滑架支架可以设置有先前讨论过但未在图7中示出的驱动磁体组件,以形成耦合器,用于磁耦合到介入装置的轮毂内的相应从动磁体。
图8示意性地示出了驱动系统的详细视图。驱动支撑件74可以由框架50承载,用于支撑驱动组件。第二驱动滑轮64以正截面图示出,由马达75经由可旋转轴76旋转驱动。可旋转轴76可以经由第一轴承78、联轴器80和第二轴承79由支撑件74可旋转地承载。马达75可以通过连接到驱动支撑件74和/或框架50的马达支架82来稳定。用于第一驱动带60和第三驱动带72的带驱动组件可以类似地构造,并在此不再进一步详细描述。
参照图9和图10,第一传动带、第二传动带和第三传动带中的每一个都围绕对应的第一惰轮84、第二惰轮86和第三惰轮88延伸。每个惰轮可设置有相应的张紧支架90,其被配置为沿近端或远端方向调节惰轮,以便调节相应带的张力。因此,每个张紧支架90设置有张紧调节件92,例如可旋转螺钉。
如图10所示,第二惰轮86例如可以由可旋转轴94承载,所述可旋转轴94通过第一轴承96和第二轴承98相对于安装支架可旋转地固定。
例如,图5A、图5B或图11中示出的任何导管通常包括在近端与远端功能端之间延伸的细长管状体。管状体的长度和直径取决于所需的应用。例如,约120cm至约140cm或更长的区域中的长度通常用于股骨通路经皮腔内冠状动脉应用。颅内或其他应用可能需要不同的导管轴长度,取决于血管通路部位。
本文公开的任何导管可设置有倾斜的远侧尖端。参见图11,远侧导管尖端110包括管状体112,所述管状体112包括前进段114、标记带116和近侧段118。内部管状内衬120可延伸穿过远侧导管尖端110的长度,并且可以包括浸涂的PTFE。
诸如编织物或弹簧圈的加强元件122嵌入外护套124中,所述外护套124可以延伸导管的整个长度。
前进段114向远端终止于倾斜面126,以提供前侧壁部分128,所述前侧壁部分128具有在标记带116的远端130和远侧尖端132之间测量的长度。在示出的实施方案中,前进段114的后侧壁部分134具有大约等于前侧壁部分128的轴向长度,该轴向长度是从前侧壁部分128围绕导管大约180度测量的。前侧壁部分128可具有约0.1mm至约5mm且通常约1mm至3mm的轴向长度。后侧壁部分134可以等于前侧壁部分128的轴向长度或比前侧壁部分128的轴向长度短至少约0.1或0.5或1mm或2mm或更多,这取决于所需的性能。
倾斜面126从导管的纵向轴线倾斜角度A,角度A为约45度至约80度。对于某些实施方式,该角度与导管的纵向轴线成约55度至约65度。在一种实施方式中,角度A约为60度。小于90度的角度A的一个结果是远端端口区域的主轴线伸长,这增加了端口的表面积并且可以增强凝块抽吸或保留。与圆形端口(角度A为90度)的表面积相比,倾斜端口的面积通常为至少约105%,且不超过约130%,在一些实施方式中为约110%至约125%,在一个实例中为相应圆形端口的面积的大约115%(角度A为90度)。
在示出的实施方案中,前进段的轴向长度围绕导管的圆周基本恒定,使得倾斜面126大致平行于标记带116的远端表面136。标记带116具有大致横向于导管的纵向轴线的近端表面,产生在侧视图中具有直梯形构造的标记带116。短侧壁138与后侧壁部分134旋转地对齐,并且具有约0.2mm至约4mm、并且通常约0.5mm至约2mm的轴向长度。相对的长侧壁140与前侧壁部分128旋转地对齐。标记带116的长侧壁140通常比短侧壁138长至少约10%或20%,并且可以比短侧壁138长至少约50%或70%或90%或更多,这取决于所需的性能。通常,长侧壁140将具有至少约0.5mm或1mm且小于约5mm或4mm的长度。
标记带可以是连续的环形结构,或者可以在其整个长度上具有至少一个并且任选地两个或三个或更多个轴向延伸的狭缝。狭缝可位于短侧壁138或长侧壁140上或位于短侧壁138和长侧壁140之间,这取决于所需的弯曲特性。标记带可包括多种不透射线材料中的任何一种,例如铂/铱合金,其壁厚优选不超过约0.003英寸,并且在一个实施方式中为约0.001英寸。
组装的导管的标记带区域可以具有相对高的弯曲刚度和高抗压强度,例如比近端段18小至少约50%或至少约100%,但通常比近端段118小不超过约200%。高抗压强度可以向相邻的前进段114并且特别是向前侧壁部分128提供径向支撑,以促进远端尖端132在经腔前进期间用作无损伤缓冲器并防止在真空下塌陷。近端段118优选地具有比标记带区域更低的弯曲刚度,并且前进段114优选地具有甚至比近端段118更低的弯曲刚度和抗压强度。
前进段114可以包括外管状护套124的远端延伸部和任选地内衬120,而在标记带116的远侧没有其他内部支撑结构。外护套124可包括挤出的Tecothane。前进段114可具有不超过约50%的弯曲刚度和径向压溃刚度,并且在一些实施方式中不超过近侧段118的相应值的约25%或15%或5%或更少。
导管可以进一步包括轴向张力元件或支撑件,例如带或一个或多个长丝或纤维,用于增加远端区域中的抗拉力和/或影响远端区域中的弯曲特性。张力支撑件可包括一个或多个轴向延伸的单股或多股长丝142。一个或多个张力元件142可轴向地放置在导管远端附近的导管壁内部。一个或多个张力元件142可用作张力支撑件并抵抗导管壁在张力下的尖端脱离或伸长(例如,当导管通过扭结的外导管或曲折或狭窄的脉管系统向近侧缩回时)。
一个或多个张力元件142中的至少一个可沿着导管壁的长度从距导管远端约1.0cm内向近侧延伸至距导管远端小于约10cm、距导管远端小于约20cm、距导管远端小于约30cm、距导管远端小于约40cm、或距导管远端小于约50cm。
一个或多个张力元件142可具有大于或等于约40cm、大于或等于约30cm、大于或等于约20cm、大于或等于约10cm、或大于或等于约5cm的长度。
一个或多个张力元件142中的至少一个可延伸至少约导管长度的最远端50cm、至少约导管长度的最远端40cm、至少约导管长度的最远端30cm或20cm或10cm。
在一些实施方式中,张力元件沿着线圈24的长度从导管的远端向近端延伸并且在远端线圈和近端线圈之间的过渡部的任一侧的约5cm或2cm或更小的范围内向近端终止。张力元件可以在过渡处终止而不与编织物(braid)重叠。
一个或多个张力元件142可放置在内衬120附近或径向外部。一个或多个张力元件142可放置在编织物和/或线圈附近或径向内部。一个或多个张力元件142可以承载在内衬120和螺旋线圈之间,并且可以在添加下一个外部相邻层(例如线圈)之前通过粘合剂固定到内衬或其他下层表面。优选地,张力元件142例如通过粘合剂或通过机械干涉固定至标记带116。在一个实施方式中,张力元件142在标记带的第一表面(例如,内侧表面)上向远侧延伸超过标记带,然后围绕标记带的远端缠绕,并沿着第二表面(例如外侧表面)在近端倾斜方向或圆周方向中的一个或两个方向延伸,以完全围绕标记带缠绕。
当多于一个的张力元件142或长丝束在导管壁中周向间隔开时,张力元件142可以以径向对称的方式放置。例如,两个张力元件142之间相对于导管的径向中心的角度可以是约180度。或者,根据所需的临床性能(例如,灵活性、可跟踪性),张力元件142可以以径向不对称的方式放置。任何两个张力元件142之间相对于导管的径向中心的角度可以小于约180度、小于或等于约165度、小于或等于约135度、小于或等于约120度、小于或等于约90度、小于或等于约45度、或者小于或等于约15度。
一个或多个张力元件142可以包括诸如维克特纶(Vectran)、Kevlar、聚酯(Polyester)、间位-对位-芳纶(Meta-Para-Aramide)或它们的任意组合的材料。一个或多个张力元件142中的至少一个可以包括单一纤维或多纤维束,并且纤维或束可具有圆形或矩形(例如带状)横截面。术语“纤维”或“长丝”并不表示成分,并且它们可以包含多种高拉伸强度聚合物、金属或合金中的任何一种,这取决于设计考虑因素,例如期望的拉伸失效极限和壁厚。当沿径向方向测量时,一个或多个张力元件142的横截面尺寸可以不大于导管10的横截面尺寸的约2%、5%、8%、15%或20%。
一个或多个张力元件142的横截面尺寸(沿径向测量)可不超过约0.001英寸、不超过约0.002英寸、不超过约0.004英寸、不超过约0.006英寸、不超过约0.008英寸或约0.015英寸。
一个或多个张力元件142可在张力作用下失效(例如,标记带脱离)之前将导管的远端区的拉伸强度增加至至少约1磅、至少约2磅、至少约3磅、至少约4磅、至少约5磅、至少约6磅、至少约7磅、至少约8磅、或至少约10磅或更多。
取决于所需数据,多种传感器中的任一种可以设置在导管、轮毂、滑架或台中的任一个上。例如,在本发明的一些实施方式中,可能需要测量例如沿着力感测区域施加到导管的轴向张力或压缩力。导管的远端将采用与图11所示类似的结构构建,具有螺旋线圈远端部分。但不是使用镍钛诺线的单个螺旋线圈,而是将第一导体140和第二导体142缠绕成交织的螺旋线圈并且例如通过管状体的塑料/树脂彼此电绝缘。参见图12A。每个线圈通过独特的电导体(例如导线的导电迹线或近端延伸部)与近端轮毂电通信。
这种双电绝缘螺旋线圈的构造形成电容器。这大致相当于两块镍钛诺板,其间有塑料层,如图12B所示。电容与导线之间的距离成反比。唯一会改变的变量是d,即板之间的距离。如果向导管施加轴向压缩力,则线140和142将移动得更靠近在一起,从而增加电容。如果施加轴向拉力,导线将进一步分开,从而降低电容。可以在导管的近端测量该电容,从而测量螺旋电容器处的力。尽管被称为电容器,但该传感器正在测量两个线圈之间的电相互作用。由于施加的轴向力,电感可能会发生可测量的变化或产生其他变化。
至少第一螺旋电容器的每个导线可具有至少一圈、五圈、十圈或更多圈完整的旋转。电容器可以位于导管体的最远端5或10或20cm内,以感测远端受到的力。至少第二电容器可设置在导管体的最近端5或10或20cm内,以感测在导管的近端处受到的力。
还可能需要使用磁耦合的天然弹性(顺应性)来测量轮毂和相应滑架之间的磁耦合上的弹力,以测量施加到轮毂上的力。轮毂和滑架之间的磁耦合产生弹性。当对轮毂施加力时,轮毂将相对于滑架少量移动。参见图13A。在机器人学中,这称为串联弹性驱动器。该性质可用于测量从滑架施加到轮毂的力。为了测量该力,需要确定轮毂和滑架之间的相对距离(图13A中所示的dx)并表征两个部件之间的一些有效弹簧常数k。参见图13B。
可以通过多种不同的方式测量相对距离。
测量圆盘和滑架之间的相对距离的一种方法是磁性传感器(例如,轮毂和滑架之间的霍尔效应传感器)。磁体安装在轮毂或滑架上,相应的磁传感器安装在另一个装置(滑架或轮毂)上。磁传感器可以是霍尔效应传感器、磁阻传感器或其他类型的磁场传感器。通常,可以使用多种传感器来提高测量的可靠性。这减少了噪音并减少了外部磁场的干扰。
也可以使用其他非接触式距离传感器。这些传感器包括光学传感器、电感传感器和电容传感器。光学传感器优选地以避免血液或其他流体积聚在轮毂和滑架之间的界面中的方式配置。
轮毂和滑架之间的磁耦合的脱离阈值可以是约300克或1000克或更大。处理器可以被配置为将施加到导管的轴向力与预设的轴向触发力进行比较,如果该轴向触发力被施加到导管,则认为该轴向触发力会对患者造成风险。如果达到触发力,则处理器可以被配置为向医生生成诸如视觉、听觉或触觉反馈的响应,和/或干预并停止导管的进一步前进,直到完成重置。可以提供超控特征,使得在医生认为增量力是必要的情况下,医生可以选择以高于触发力的力继续推进导管。
力和/或扭矩感测光纤(例如,光纤布拉格光栅(FBG)传感器)可以建立在导管侧壁中,以测量沿着导管的轴的各个位置处的力和/或扭矩,或者可替代地可以集成到导丝中。光纤测量轴向应变,所述轴向应变可以转换为轴向力或扭矩(螺旋缠绕时)。至少第一FBG传感器可以集成到导管或导丝上的远端感测区、近端感测区和/或中间感测区中,以测量传感器附近的力和/或扭矩。
还可能需要了解在经血管放置期间和/或之后导管或导丝的三维构造。形状传感光纤,例如用于感测导管和导丝形状的FBG光纤阵列。通过使用彼此距离已知的多个力感测纤维,可以确定沿导管/导丝长度的形状。
电阻应变计可以集成到导管或导丝的主体中以测量力或扭矩。例如在装置的远端和/或近端。
可以以多种方式确定轮毂(和对应的导管)沿着工作台的长度的绝对位置。例如,非接触式磁性传感器可以被配置为穿过无菌屏障直接测量轮毂的位置。相同类型的传感器还可以被配置为测量滑架的位置。每个轮毂可具有至少一个附接到其上的磁体。机器人工作台将具有沿工作台整个长度排列的相应磁传感器的线性阵列。处理器可以被配置为确定磁体沿着线性传感器阵列的长度的位置,并向医生显示轴向位置信息。
前述内容可替代地使用非接触式电感式传感器来穿过无菌屏障直接测量圆盘位置来实现。每个轮毂或滑架中可设有电感“目标”。机器人工作台可以在工作台的整个工作长度上设置有电感式传感阵列。作为另一替代方案,绝对线性编码器可用于直接测量轮毂或滑架的线性位置。编码器可以使用多种不同技术中的任何一种,包括光学、磁型、电感和电容方法。
在一种实施方式中,每个轮毂可以承载无源(无电连接)目标线圈。线性印刷电路板可以贯穿工作台的整个工作长度(例如,至少约5’或6’),其被配置为发送(ping)询问器信号,所述询问器信号刺激来自无源线圈的返回信号。PCB被配置为识别返回信号及其位置。
滑架的轴向位置可以使用多转旋转编码器来确定,以测量滑轮的旋转位置,其与滑架的线性位置直接相关。或者,可以通过记录步进电机的指令步数,以测量滑轮的旋转位置,所述滑轮的旋转位置与滑架的线性位置直接相关。
解剖结构内的导管和导丝的位置还可通过用机器视觉处理荧光透视图像来确定,例如以确定远端尖端位置、远端尖端方向和/或导丝形状。该处理可以实时完成,以至多30hz(荧光灯的最大速度)提供位置/方向数据,尽管该技术仅在荧光灯开启时提供数据。
施加到导管或导丝轴的近端扭矩可以使用双编码器扭矩传感器来确定。参照图14,第一编码器144和第二编码器146可沿轴148轴向间隔开,用于测量柔性导管/管的长度上的角度差。由于导管/管具有已知的扭转刚度,因此角度差被内插为扭矩。当扭矩施加到轴上时,轴的稍有柔性的部分将会扭转。编码器测量的角度之间的差(dθ)告诉我们扭矩。T=k*dθ,其中k是扭转刚度。
确认流体管线中不存在气泡也可以使用气泡传感器来完成,特别是在医生远离患者的情况下。这可以使用非接触式超声波传感器来实现,该传感器测量通过流体管道侧壁的反射超声波的强度和多普勒频移,以检测气泡并测量流体流速或液位。超声波或光学传感器可以定位在轮毂内的进入流体流动路径附近,或者在通向轮毂的供应管线中。为了检测输注管线(由超声或光学透射材料形成)中气泡的存在,传感器可以包括位于流动路径第一侧的信号源和位于流动路径第二侧的接收器,以测量通过管的液体的透射率来检测气泡。或者,由于气泡的回声相对高,反射的超声信号可以从流动路径的与源相同的一侧检测到。
优选地,气泡去除系统在检测到在线气泡时自动启动。处理器可以被配置为在检测到气泡时启动位于气泡检测器下游的流动路径中的阀。该阀将流体柱从流动路径分流到患者并进入储液器。一旦在流动路径中不再检测到气泡,并且在检测器和阀之间的流动路径中的流体体积已经通过阀之后,可以启动阀以通过流体路径将流体源与患者重新连接。
此外,医生可能希望能够在无菌区内的某个位置查看抽吸的凝块,出于流体管理目的,该位置优选尽可能靠近患者。这可以通过提供安装在轮毂上或安装在泵方向上远离轮毂的抽吸管线中的凝块回收装置来实现。参考图15,凝块取出装置370的一个实例可以包括封闭腔室381的主体380,主体380与第一端口310和第二端口320连通。在一些实例中,主体380可以包括冲洗端口(未示出),所述冲洗端口被配置为允许盐水或其他流体注入腔室381中,以在凝块被截留在过滤器330中时提高凝块的可视性。
在一些实施方案中,主体380包括具有顶部382和底部384的壳体。主体380可以包括位于顶部382和底部384之间的腔室381中的过滤器330。在一些实例中,第一端口310被配置为连接到第一管340的第一端,所述第一管340流体连接到抽吸导管的近端。在被配置为连接在轮毂下游的实施方案中,第一管340包括位于第一管340的第二端的连接器342,连接器342被配置为与轮毂上或与轮毂连通的相应连接器接合或配合。第一端口310直接与过滤器上游(例如顶侧)的腔室连通,第二端口320直接与过滤器下游(例如底侧)的腔室连通,以便于直接观察过滤器上游侧捕获的物质。在被配置用于远程操作的实施方式中,可以提供多种传感器中的任何一种来检测通过抽吸管线和/或截留在过滤器中的凝块,例如光学传感器、超声波传感器或本领域已知的其他传感器。
在一些实施方案中,第二端口320被配置为连接至第二管350的第一端,该第二管350流体连接至抽吸源(例如泵)。在一些实施方案中,第二管350包括位于第二管350的第二端的连接器352,该连接器352被配置为与泵上的相应连接器接合或配合。在一些实例中,系统300可以包括夹具360。夹具360可定位在第一管340上,以允许使用者接合夹具并提供对凝块取回装置370的流量控制。
主体380可以具有通过管状侧壁与底表面间隔开的顶表面。在示出的实施方式中,顶表面和底表面基本上是圆形的,并且由圆柱形侧壁间隔开,该侧壁的直径至少是侧壁的轴向长度(横向于顶表面和底表面)的约三倍或五倍或更多倍,以产生大致盘形的壳体。优选地,顶壁的至少一部分是光学透明的,以在凝块被截留在凝块取回装置370中时提高凝块的可视性。其他细节可以在美国专利申请第63/256,743号中找到,其每项的全部内容在此通过引用并入本文。
上述内容描述了驱动台和相关导管的某些具体实施方式。如本领域技术人员根据本文的公开内容所理解的,可以制造多种不同的驱动台结构,用于支撑和轴向推进和缩回两个、三个、四个或更多个驱动磁体组件,以机器人式地驱动介入装置。
示例性实施方案
一种主动脉上血管通路机器人控制系统,包括以下中的一项或多项:
导丝轮毂,被配置为调节导丝的轴向位置和旋转位置中的每一个;
引导导管轮毂,被配置为在轴向方向上调节引导导管;以及
第二导管轮毂,被配置为调节第二导管的轴向位置和旋转位置中的每一个,并且还横向偏转第二导管的远端偏转区。
如本文任一实施方案所述的控制系统,其中第二导管是抽吸导管。
如本文任一实施方案所述的控制系统,其中第二导管是栓塞部署导管。
如本文任一实施方案所述的控制系统,其中第二导管被配置为部署栓塞线圈。
如本文任一实施方案所述的控制系统,其中第二导管是支架部署导管。
如本文任一实施方案所述的控制系统,其中第二导管被配置为部署支架取栓器(stentriever)。
如本文任一实施方案所述的控制系统,其中第二导管是分流器部署导管。
如本文任一实施方案所述的控制系统,其中第二导管是诊断性血管造影导管。
如本文任一实施方案所述的控制系统,其进一步包括导丝轮毂上的从动磁体,该从动磁体被配置为与驱动磁体协作,使得从动磁体响应于驱动磁体的移动而移动。
如本文任一实施方案所述的控制系统,其中驱动磁体由支撑台轴向可移动地承载。
如本文任一实施方案所述的控制系统,其中驱动磁体在通过屏障与驱动磁体间隔开的无菌区外移动,并且从动磁体在无菌区内。
如本文任一实施方案所述的控制系统,其中屏障包括聚合物膜。
如本文任一实施方案所述的控制系统,其进一步包括远离支撑台的控制台。
如本文任一实施方案所述的控制系统,其中从动磁体的位置响应于控制台上的导丝驱动控制器的操纵而可移动。
如本文任一实施方案所述的控制系统,其进一步包括用于控制从动磁体的位置的处理器,并且处理器与控制台有线通信。
如本文任一实施方案所述的控制系统,其进一步包括用于控制从动磁体的位置的处理器,并且处理器与控制台无线通信。
如本文任一实施方案所述的控制系统,其中从动磁体将保持与驱动磁体接合,直到所施加的力达到破坏力阈值,超过该阈值,从动磁体将与驱动磁体解耦。
如本文任一实施方案所述的控制系统,其中破坏力阈值为至少约300克。
如本文任一实施方案所述的控制系统,其进一步包括传感器,所述传感器被配置为测量从动磁体和驱动磁体之间所施加的力。
如本文任一实施方案所述的控制系统,其进一步包括处理器,所述处理器被配置为将所施加的力与破坏力阈值进行比较。
如本文任一实施方案所述的控制系统,其中处理器被配置为当所施加的力达到低于破坏力阈值的预设值时调节驱动磁体的移动速率。
如本文任一实施方案所述的控制系统,其中传感器包括应变计。
如本文任一实施方案所述的控制系统,其中处理器被配置为当所施加的力达到低于破坏力阈值的预设值时停止驱动磁体的移动。
机器人驱动的介入装置,包括以下的一项或多项:
细长的柔性体,具有近端和远端;
所述近端上的轮毂;
轮毂的第一表面上的至少一个可旋转辊;以及
轮毂的第一表面上的至少一个磁体。
如本文任一实施方案所述的机器人驱动的介入装置,其中辊比磁体延伸得更远离第一表面。
如本文任一实施方案所述的机器人驱动的介入装置,其进一步包括至少第二辊。
如本文任一实施方案所述的机器人驱动的介入装置,其进一步包括轮毂内的旋转驱动器,用于使介入装置相对于轮毂旋转。
如本文任一实施方案所述的机器人驱动的介入装置,其进一步包括轮毂内的缩回机构,用于向近端延伸通过介入装置的牵引元件。
如本文任一实施方案所述的机器人驱动的介入装置,其中牵引元件包括牵引线。
如本文任一实施方案所述的机器人驱动的介入装置,其中牵引元件包括牵引管。
如本文任一实施方案所述的机器人驱动的介入装置,其中管状体的一部分的形状响应于牵引元件的向近端缩回而改变。
如本文任一实施方案所述的机器人驱动的介入装置,其中管状体的一部分的刚度特性响应于牵引元件的向近端缩回而改变。
如本文任一实施方案所述的机器人驱动的介入装置,其进一步包括细长柔性体上的传感器。
如本文任一实施方案所述的机器人驱动的介入装置,其中传感器包括轴向力传感器。
如本文任一实施方案所述的机器人驱动的介入装置,其中柔性体的远端部分包括至少第一电导体,所述第一电导体与第二电导体轴向间隔开并且与第二电导体绝缘。
如本文任一实施方案所述的机器人驱动的介入装置,其中第一电导体和第二电导体是导线的相邻螺旋绕组。
如本文任一实施方案所述的机器人驱动的介入装置,其中传感器包括氧气传感器。
如本文任一实施方案所述的机器人驱动的介入装置,其中传感器包括导管形状传感器。
如本文任一实施方案所述的机器人驱动的介入装置,其中传感器包括导管位置传感器。
如本文任一实施方案所述的机器人驱动的介入装置,其中柔性体包括引导导管。
如本文任一实施方案所述的机器人驱动的介入装置,其中柔性体包括导丝。
如本文任一实施方案所述的机器人驱动的介入装置,其中柔性体包括通路导管。
如本文任一实施方案所述的机器人驱动的介入装置,其中柔性体包括抽吸导管。
如本文任一实施方案所述的机器人驱动的介入装置,其包括光纤布拉格光栅传感器。
如本文任一实施方案所述的机器人驱动的介入装置,其进一步包括与轮毂流体连通的凝块过滤器。
如本文任一实施方案所述的机器人驱动的介入装置,其中凝块过滤器由轮毂承载。
如本文任一实施方案所述的机器人驱动的介入装置,其中凝块过滤器具有透明侧壁,以允许对捕获的凝块进行视觉检查。
如本文任一实施方案所述的机器人驱动的介入装置,其进一步包括气泡检测器,所述气泡检测器与通过轮毂的流动路径流体连通。
如本文任一实施方案所述的机器人驱动的介入装置,其中气泡检测器由轮毂承载。
如本文任一实施方案所述的机器人驱动的介入装置,其进一步包括流动路径中的阀、以及被配置为响应于流体路径中气泡的检测而调节该阀的处理器。
如本文任一实施方案所述的机器人驱动的介入装置,其中气泡响应于阀的调节而从流动路径中分流出来。
用于将介入装置传送至机器人手术部位的无菌包装组件,包括以下的一项或多项:
无菌屏障,具有轮毂支撑部分并被配置为封闭无菌体积;以及
无菌体积内的至少第一介入装置,所述第一介入装置包括轮毂和细长柔性体,所述轮毂包括至少一个磁体和至少一个辊,所述辊被配置为在轮毂支撑部分上滚动。
如本文任一实施方案所述的无菌包装组件,其中轮毂支撑部分被配置为位于患者附近的支撑台上,轮毂支撑部分的上表面位于无菌区内,轮毂支撑部分的下表面位于无菌区外。
如本文任一实施方案所述的无菌包装组件,其中当轮毂支撑部分位于支撑台上时,轮毂支撑部分基本上是水平的。
如本文任一实施方案所述的无菌包装组件,其中当轮毂支撑部分位于支撑台上时,轮毂支撑部分相对于水平面倾斜。
如本文任一实施方案所述的无菌包装组件,其中轮毂进一步包括至少一个流体注入端口。
如本文任一实施方案所述的无菌包装组件,其中轮毂进一步包括无线RF收发器。
如本文任一实施方案所述的无菌包装组件,其进一步包括轮毂上的视觉指示器,用于指示凝块的存在。
如本文任一实施方案所述的无菌包装组件,其中视觉指示器包括具有透明窗口的凝块收集室。
如本文任一实施方案所述的无菌包装组件,其进一步包括凝块室中的过滤器。
如本文任一实施方案所述的无菌包装组件,其进一步包括用于检测凝块的存在的传感器。
如本文任一实施方案所述的无菌包装组件,其中传感器包括压力传感器。
如本文任一实施方案所述的无菌包装组件,其中传感器包括光学传感器。
如本文任一实施方案所述的无菌包装组件,其中轮毂支撑部分包括具有纵轴的细长聚合物膜。
如本文任一实施方案所述的无菌包装组件,其中无菌屏障额外包括邻近轮毂支撑部分的至少第一存储托盘。
如本文任一实施方案所述的无菌包装组件,包括邻近轮毂支撑部分的第一存储托盘和第二存储托盘。
如本文任一实施方案所述的无菌包装组件,其中第一存储托盘位于轮毂支撑部分的第一侧,第二存储托盘位于轮毂支撑部分的第二侧。
如本文任一实施方案所述的无菌包装组件,包括邻近轮毂支撑部分的第一存储托盘和第二存储托盘。
如本文任一实施方案所述的无菌包装组件,其中第一介入装置包含在第一存储托盘内。
如本文任一实施方案所述的无菌包装组件,其中第一介入装置是引导导管。
如本文任一实施方案所述的无菌包装组件,其中第一介入装置是通路导管。
如本文任一实施方案所述的无菌包装组件,其中第一介入装置是导丝。
如本文任一实施方案所述的无菌包装组件,其中第一介入装置是抽吸导管。
如本文任一实施方案所述的无菌包装组件,包括第一存储托盘中的主动脉上血管通路组件。
如本文任一实施方案所述的无菌包装组件,其中通路组件包括导丝、通路导管和引导导管。
如本文任一实施方案所述的无菌包装组件,其进一步包括无菌体积内的手术组件。
如本文任一实施方案所述的无菌包装组件,其中手术组件包括导丝和抽吸导管。
如本文任一实施方案所述的无菌包装组件,其中手术组件被承载在第二存储托盘中。
如本文任一实施方案所述的无菌包装组件,其中无菌屏障是磁可透过的。
如本文任一实施方案所述的无菌包装组件,其中无菌屏障是流体不可透过的。
如本文任一实施方案所述的无菌包装组件,其中无菌屏障是射频可透过的。
如本文任一实施方案所述的无菌包装组件,其中无菌屏障对于微生物是不可透过的。
如本文任一实施方案所述的无菌包装组件,其中无菌屏障是半透明的。
如本文任一实施方案所述的无菌包装组件,其中无菌屏障是透明的。
如本文任一实施方案所述的无菌包装组件,其中轮毂支撑部分具有凸曲率,使得流体被配置为从轮毂支撑部分流出。
如本文任一实施方案所述的无菌包装组件,其中轮毂支撑部分具有纵轴和横轴,并且轮毂支撑部分在沿横轴向上方向上凸起。
如本文任一实施方案所述的无菌包装组件,其中无菌屏障包含在外包装内。
如本文任一实施方案所述的无菌包装组件,其中无菌屏障包括非顺应性聚合物。
如本文任一实施方案所述的无菌包装组件,其中非顺应性聚合物包括聚对苯二甲酸乙二醇酯(PET)或热塑性聚氨酯。
如本文任一实施方案所述的无菌包装组件,其中无菌屏障进一步包括可拆卸覆盖部分,所述可拆卸覆盖部分与轮毂支撑部分配合以界定无菌体积。
如本文任一实施方案所述的无菌包装组件,其中轮毂经由至少一个磁体可释放地耦合至轮毂支撑部分。
进行神经血管手术的方法,包括以下步骤中的一个或多个:
提供通路导管,具有通路导管轮毂;
将通路导管轮毂耦合至轮毂适配器,所述轮毂适配器由支撑台可移动地承载;
响应于轮毂适配器沿工作台的移动而驱动通路导管,直到通路导管被定位成实现主动脉上血管通路;
从轮毂适配器移除通路导管和通路导管轮毂;以及
将具有手术导管的手术导管轮毂耦合至轮毂适配器。
如本文任一实施方案所述的方法,其进一步包括推进手术导管轮毂,以将手术导管的远端定位在神经血管治疗部位。
如本文任一实施方案所述的方法,其中驱动通路导管步骤包括驱动通路导管向远端通过引导导管。
如本文任一实施方案所述的方法,其中驱动通路导管步骤包括横向偏转通路导管的远端区域以实现主动脉上血管通路的步骤。
如本文任一实施方案所述的方法,其中耦合步骤包括将通路导管轮毂磁耦合至轮毂适配器。
如本文任一实施方案所述的方法,其中通路导管轮毂和轮毂适配器由无菌区屏障间隔开。
如本文任一实施方案所述的方法,其进一步包括通过无菌屏障将引导导管轮毂耦合至引导导管适配器。
如本文任一实施方案所述的方法,其进一步包括通过无菌屏障将导丝轮毂耦合至导丝适配器。
如本文任一实施方案所述的方法,其进一步包括响应于轴向移动导丝适配器而轴向移动附接至导丝轮毂的导丝。
如本文任一实施方案所述的方法,其进一步包括相对于导丝轮毂旋转导丝。
如本文任一实施方案所述的控制系统,其中手术导管包括抽吸导管。
如本文任一实施方案所述的方法,其进一步包括抽吸凝块的步骤。
如本文任一实施方案所述的方法,其进一步包括响应于轮毂适配器沿工作台的移动而驱动通路导管,直至通路导管实现主动脉上血管通路。
如本文任一实施方案所述的方法,其进一步包括在移除通路导管的同时维持主动脉上血管通路。
如本文任一实施方案所述的方法,其进一步包括在耦合手术导管轮毂的同时维持主动脉上血管通路。
如本文任一实施方案所述的方法,其中耦合步骤包括将通路导管轮毂上的至少第一磁体耦合至轮毂适配器上的第二磁体,以形成磁耦合。
如本文任一实施方案所述的方法,其进一步包括测量磁耦合上的弹性力的步骤。
如本文任一实施方案所述的方法,其进一步包括确定施加到通路导管的力的步骤。
如本文任一实施方案所述的方法,其中力的测定使用嵌入导管侧壁的光纤来完成。
如本文任一实施方案所述的方法,其进一步包括确定轮毂适配器相对于工作台的位置的步骤。
进行神经血管手术的方法,包括以下步骤中的一个或多个:
提供通路组件,包括导丝、通路导管和引导导管;
将通路组件耦合至机器人驱动系统;
驱动通路组件,以实现主动脉上血管通路;
将导丝和通路导管与通路组件解耦;
提供手术组件,至少包括导丝和手术导管;
将手术组件耦合至机器人驱动系统;以及
使用手术组件进行神经血管手术。
如本文任一实施方案所述的方法,其中该耦合通路组件包括磁耦合导丝、通路导管和引导导管中的每一个上的轮毂,以将相应驱动磁体间隔开,所述驱动磁体可独立移动地由驱动台承载。
如本文任一实施方案所述的方法,其中该耦合通路组件至机器人驱动系统是在通路组件和机器人驱动系统不直接接触的情况下完成的。
如本文任一实施方案所述的方法,其中手术组件包括第一手术导管和第二手术导管。
如本文任一实施方案所述的方法,其中导丝和第一手术导管同心地定位在第二手术导管内。
如本文任一实施方案所述的方法,其中手术组件作为单元被推进通过引导导管的长度的至少一部分。
如本文任一实施方案所述的控制系统,其中手术导管包括神经血管血栓切除术。
如本文任一实施方案所述的方法,包括轴向推进或缩回导丝。
如本文任一实施方案所述的方法,包括相对于导丝轮毂旋转导丝。
如本文任一实施方案所述的方法,包括轴向推进或缩回通路导管。
如本文任一实施方案所述的方法,包括相对于通路导管轮毂旋转东路导管。
如本文任一实施方案所述的方法,包括横向偏转通路导管上的偏转区。
如本文任一实施方案所述的方法,其中导丝、通路导管和引导导管中的每一个上的轮毂由无菌区屏障与相应的驱动磁体间隔开。
如本文任一实施方案所述的方法,其中驱动通路组件包括响应于驱动磁体的移动而沿着无菌区屏障滚动导丝、通路导管和引导导管中的每一个上的轮毂。
如本文任一实施方案所述的方法,其进一步包括在至少一个引导丝和通路导管与通路组件解耦的同时维持主动脉上血管通路。
如本文任一实施方案所述的方法,其进一步包括在耦合手术组件的同时维持主动脉上血管通路。
如本文任一实施方案所述的方法,其进一步包括确定鼓轮中的磁体和由驱动台承载的相应磁体之间的相对运动。
如本文任一实施方案所述的方法,其进一步包括确定轮毂适配器相对于驱动台的位置。
如本文任一实施方案所述的方法,其进一步包括确定施加到通路导管的轴向力。
如本文任一实施方案所述的方法,其进一步包括确定施加到通路导管的旋转扭矩。

Claims (40)

1.用于将介入装置转移至机器人手术部位的无菌包装组件,包括:
无菌屏障,所述无菌屏障具有轮毂支撑部分并且被配置为封闭无菌体积;以及
所述无菌体积内的至少第一介入装置,所述第一介入装置包括轮毂和细长柔性体,所述轮毂包括至少一个磁体和被配置为在所述轮毂支撑部分上滚动的至少一个辊。
2.如权利要求1所述的无菌包装组件,其中所述轮毂支撑部分被配置为位于患者附近的支撑台上,所述轮毂支撑部分的上表面在无菌区内,并且所述轮毂支撑部分的下表面在所述无菌区外。
3.如权利要求2所述的无菌包装组件,其中当所述轮毂支撑部分位于所述支撑台上时,所述轮毂支撑部分基本上是水平的。
4.如权利要求2所述的无菌包装组件,其中当所述轮毂支撑部分位于所述支撑台上时,所述轮毂支撑部分相对于水平面倾斜。
5.如权利要求1所述的无菌包装组件,其中所述轮毂还包括至少一个流体注入端口。
6.如权利要求1所述的无菌包装组件,其中所述轮毂还包括无线RF收发器。
7.如权利要求1所述的无菌包装组件,其还包括在所述轮毂上的视觉指示器,用于指示凝块的存在。
8.如权利要求7所述的无菌包装组件,其中所述视觉指示器包括具有透明窗口的凝块收集室。
9.如权利要求8所述的无菌包装组件,其还包括在所述凝块室中的过滤器。
10.如权利要求1所述的无菌包装组件,其还包括用于检测凝块的存在的传感器。
11.如权利要求10所述的无菌包装组件,其中所述传感器包括压力传感器。
12.如权利要求10所述的无菌包装组件,其中所述传感器包括光学传感器。
13.如权利要求2所述的无菌包装组件,其中所述轮毂支撑部分包括具有纵轴的细长聚合物膜。
14.如权利要求13所述的无菌包装组件,其中所述无菌屏障额外包括邻近所述轮毂支撑部分的至少第一存储托盘。
15.如权利要求14所述的无菌包装组件,其包括邻近所述轮毂支撑部分的第一存储托盘和第二存储托盘。
16.如权利要求15所述的无菌包装组件,其中所述第一存储托盘在所述轮毂支撑部分的第一侧上,并且所述第二存储托盘在所述轮毂支撑部分的第二侧上。
17.如权利要求1所述的无菌包装组件,其包括邻近所述轮毂支撑部分的第一存储托盘和第二存储托盘。
18.如权利要求14所述的无菌包装组件,其中所述第一介入装置包含在所述第一存储托盘内。
19.如权利要求18所述的无菌包装组件,其中所述第一介入装置是引导导管。
20.如权利要求18所述的无菌包装组件,其中所述第一介入装置是通路导管。
21.如权利要求18所述的无菌包装组件,其中所述第一介入装置是导丝。
22.如权利要求18所述的无菌包装组件,其中所述第一介入装置是抽吸导管。
23.如权利要求14所述的无菌包装组件,其包括在所述第一存储托盘中的主动脉上血管通路组件。
24.如权利要求23所述的无菌包装组件,其中所述通路组件包括导丝、通路导管和引导导管。
25.如权利要求24所述的无菌包装组件,其还包括在所述无菌体积内的手术组件。
26.如权利要求25所述的无菌包装组件,其中所述手术组件包括导丝和抽吸导管。
27.如权利要求26所述的无菌包装组件,其中所述手术组件被承载在第二存储托盘中。
28.如权利要求1所述的无菌包装组件,其中所述无菌屏障是磁可透过的。
29.如权利要求1所述的无菌包装组件,其中所述无菌屏障是流体不可透过的。
30.如权利要求1所述的无菌包装组件,其中所述无菌屏障是射频可透过的。
31.如权利要求1所述的无菌包装组件,其中所述无菌屏障对于微生物是不可透过的。
32.如权利要求1所述的无菌包装组件,其中所述无菌屏障是半透明的。
33.如权利要求1所述的无菌包装组件,其中所述无菌屏障是透明的。
34.如权利要求1所述的无菌包装组件,其中所述轮毂支撑部分具有凸曲率,使得流体被配置为从所述轮毂支撑部分流出。
35.如权利要求34所述的无菌包装组件,其中所述轮毂支撑部分具有纵轴和横轴,并且所述轮毂支撑部分在所述横轴的向上方向上凸起。
36.如权利要求1所述的无菌包装组件,其中所述无菌屏障包含在外包装内。
37.如权利要求1所述的无菌包装组件,其中所述无菌屏障包括非顺应性聚合物。
38.如权利要求37所述的无菌包装组件,其中所述非顺应性聚合物包括聚对苯二甲酸乙二醇酯(PET)或热塑性聚氨酯。
39.如权利要求1所述的无菌包装组件,其中所述无菌屏障进一步包括可拆卸覆盖部分,所述可拆卸覆盖部分与所述轮毂支撑部分配合以界定所述无菌体积。
40.如权利要求1所述的无菌包装组件,其中所述轮毂经由所述至少一个磁体可释放地耦合至所述轮毂支撑部分。
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US12558175B2 (en) 2026-02-24
US20230046468A1 (en) 2023-02-16
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US20230048388A1 (en) 2023-02-16
US12232838B2 (en) 2025-02-25
US20230048055A1 (en) 2023-02-16
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US12376928B2 (en) 2025-08-05

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