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CN111184576B - 冲洗球囊导管以用于在血管分叉情况下观察和移除凝块 - Google Patents

冲洗球囊导管以用于在血管分叉情况下观察和移除凝块 Download PDF

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CN111184576B
CN111184576B CN201911118590.7A CN201911118590A CN111184576B CN 111184576 B CN111184576 B CN 111184576B CN 201911118590 A CN201911118590 A CN 201911118590A CN 111184576 B CN111184576 B CN 111184576B
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clot
catheter
distal end
sealing
bifurcation
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CN111184576A (zh
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A.戈瓦里
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Biosense Webster Israel Ltd
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Abstract

本发明题为“冲洗球囊导管以用于在血管分叉情况下观察和移除凝块”。本发明公开了一种导管，该导管包括轴、密封球囊、分叉密封元件和相机。该轴具有用于插入到患者的脑的凝结血管内的远侧端部。装配在该远侧端部的近侧区段处的密封球囊被配置成在近侧密封凝结血管的一部分。该分叉密封元件在密封球囊的远侧装配在远侧端部处，并且被配置成密封位于凝结血管的近侧密封部分处的分叉。装配在远侧端部的远侧边缘处的相机被配置成对使血管凝结的凝块视觉成像。

Description

冲洗球囊导管以用于在血管分叉情况下观察和移除凝块
技术领域
本发明整体涉及医疗探头，并且具体地讲，涉及用于脑血管应用的导管。
背景技术
各种类型的医疗探头诸如导管包括位于探头的远侧端部处的光学元件和机械元件。例如，美国专利申请公布2017/0265879描述了一种一体式凝块排出装置，该一体式凝块排出装置具有可视化特性以用于神经外科应用，尤其可用于排出因颅内出血(ICH)而形成的凝块。该装置还可包括用于使脑和凝块自身的内部可视化的一体式相机和灯。此外，该装置被配置成通过抽吸和冲洗来排出凝块。
又如，美国专利4,445,892描述了一种双球囊导管装置，该双球囊导管装置设置有用于闭塞血管的区段的两个间隔开的且可扩张的球囊。该装置还包括用于冲洗闭塞区段的第一通道、可用于该区段中的光学系统、以及用于将流体引入到位于装置远侧的血管内的第二通道。
美国专利6,575,932描述了一种局部递送装置，该局部递送装置包括远侧导管单元和可通过在远侧导管单元上滑动来定位的近侧导管单元。远侧导管单元和近侧导管单元均具有单独的可膨胀闭塞球囊。导管单元通过相对于彼此滑动而形成的定位提供了可变的球囊间距离，这继而在中空管状器官例如血管中提供了可变尺寸的闭塞区域。多个输注孔口分散在两个闭塞球囊之间的导管轴上，通过多个输注孔口可将治疗剂递送到中空管状器官的闭塞区域。局部递送装置还可包括用于确定两个闭塞球囊之间的距离的量化装置。因此，球囊间距离的精确调节允许将治疗剂受控地递送到中空管状器官壁的分立长度。
美国专利5,007,898描述了一种用于治疗阻塞性前列腺炎的症状的设备和方法。该设备包括适于经尿道插入的可扩张膨胀导管和轴向细长护套。多个冲洗孔口设置在导管的可扩张膨胀部分的近侧端部附近。盐水溶液流过冲洗导管并且穿过冲洗孔口而渗出，以便从膀胱镜的透镜冲洗掉血液等，由此为泌尿科医师提供膨胀导管和外部尿道括约肌的无阻挡的视图。
美国专利6,702,782描述了一种具有至少两个管腔的球囊导管。管腔中的一个为大的工作管腔。球囊导管尤其可用作引导导管，并且可用于多种治疗和诊断规程中。具体地，它的价值在于与穿过该工作管腔递送到中风部位的其他装置相结合来治疗神经血管栓塞性中风。当旨在用于治疗栓塞性中风时，导管可为包括异物回收器的套件的部件。此外，在其他规程中，该发明包括临时地阻挡血管管腔、移除神经血管或周边栓子的方法。
美国专利7,588,535描述了一种用于在血管内环境中为目标区域的摄影图像提供图像增强效果的设备、系统和方法。该设备具有多个不同实施方案，在该实施方案中的每个中减少所检测的环境“噪声”以及从目标区域反射的光，以便增大信噪比，从而提高所产生的图像的质量。在一个实施方案中，利用盐水冲洗血管内环境以便允许视频图像采集。
发明内容
本发明的实施方案提供了一种医疗系统，该医疗系统包括轴、密封球囊、分叉密封元件和相机。轴具有用于插入到患者的脑的凝结血管内的远侧端部。装配在远侧端部的近侧区段处的密封球囊被配置成在近侧密封凝结血管的一部分。分叉密封元件在密封球囊的远侧装配在远侧端部处，并且被配置成密封位于凝结血管的近侧密封部分处的分叉。装配在远侧端部的远侧边缘处的相机被配置成对使血管凝结的凝块视觉成像。
在一些实施方案中，分叉密封元件包括可移动式密封板。
在一些实施方案中，远侧端部还包括被配置成抵靠分叉挤压分叉密封元件的可膨胀构件。
在一个实施方案中，远侧端部还包括被配置成抵靠分叉挤压分叉密封元件的弹性构件。
在另一个实施方案中，远侧端部还包括被配置成引导凝块移除装置的工作通道。
在一些实施方案中，远侧端部还包括被配置成使流体流入近侧密封部分内的工作通道。
在一些实施方案中，远侧端部还包括被配置成将抽吸低压输送到近侧密封部分内以便抽出凝块的工作通道。
根据本发明的实施方案，另外提供了一种导管插入方法，该导管插入方法包括将具有远侧端部的轴插入到患者的脑的凝结血管内。利用装配在远侧端部的近侧区段处的密封球囊在近侧密封凝结血管的一部分。利用在密封球囊的远侧装配在远侧端部处的分叉密封元件来密封位于凝结血管的近侧密封部分处的分叉。利用装配在远侧端部的远侧边缘处的相机对使血管凝结的凝块进行视觉成像。
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为根据本发明的实施方案的用于凝块的视觉检查和凝块移除的基于脑血管导管的系统的示意性图解；
图2为根据本发明的实施方案的被配置成执行凝块的视觉成像的导管的远侧端部的视图；并且
图3为根据本发明的实施方案示意性地示出用于使凝块可视化并相应地选择治疗的方法的流程图。
具体实施方式
概述
脑的大血管(例如动脉)中的栓塞凝块为医疗紧急病症。可在注入造影剂的情况下利用计算机断层摄影(CT)或荧光镜成像来检测凝块在脑中的位置。然而，此类医学成像方法不能使凝块可视化。
凝块的清晰可视化可有助于确定适当的治疗方法。例如，如果凝块通过视觉检查被评估为相对实体的，则医师可尝试利用支架抓紧并回缩凝块来移除凝块。另一方面，如果凝块的视觉检查导致医师评估凝块是较为蜡状的，则医师可尝试通过抽吸来抽出凝块。
在导管插入术期间，可通过例如在利用盐水溶液从血管的凝结容积冲洗遮挡血液之后采集凝块的彩色图像来视觉检查凝块。遗憾的是，在一些情况下，凝块紧邻血管分叉而形成。分叉阻碍此类凝块的视觉检查，因为来自分流血管的连续血液渗漏遮挡凝块。由于医师不能视觉检查凝块并相应地确定治疗方法，因此医师可需要猜测要使用的治疗方法。
下文所述的本发明的实施方案提供了一种允许医师在血管分叉情况下视觉检查凝块的导管。本发明所公开的导管包括(a)轴，该轴具有用于插入到患者的脑的凝结血管内的远侧端部，以及(b)位于轴的远侧端部处的下述元件：用以封闭分叉的分叉密封元件，诸如可移动式密封片；可扩张密封球囊，该可扩张密封球囊位于远侧端部的近侧区段处，以在近侧密封血管的凝结部分；一个或多个工作通道，该一个或多个工作通道为例如用于冲洗血管的密封部分的装置提供通路；以及相机，该相机位于远侧端部的远侧边缘处，以对凝块进行视觉成像。
在一个实施方案中，将导管插入到凝结动脉内，直到相机处于凝块的视觉范围中。扩张密封球囊以便在近侧密封相机与凝块之间的动脉部分。通常被配置成密封具有一(1)毫米至十(10)毫米尺寸的分叉的可移动式密封片被部署以封闭分叉，以便建立动脉的密封部分。然后利用例如泵送穿过工作通道中的一个或多个的盐水溶液冲洗密封部分(即，动脉容积)，以便利用盐水替换该容积中的血液。在视觉范围内透明的盐水允许相机采集凝块的彩色图像。彩色图像通常在监视器上显示给医师。
在一些实施方案中，在视觉检查凝块并确定其物理特性之后，医师利用工作通道来执行相应的治疗。例如，如果医师基于图像确定该凝块为实体状，则医师可通过工作通道推进凝块移除装置(诸如支架)以抓紧并回缩凝块。另一方面，如果医师基于图像断定该凝块非常柔软(例如，凝胶状和柔韧的)，则医师可将抽吸低压施加到密封部分内，以便通过工作通道抽出凝块。
本发明所公开的导管和视觉检查技术允许医师在分叉情况下视觉检查和评估凝块的物理特性。因此，本发明所公开的技术增大了在其中动脉的分叉紧邻凝块而存在的复杂情况下成功移除凝块的可能性。因此，本发明所公开的导管和方法可改善用于消除脑凝块的医疗紧急导管插入术的临床结果。
系统说明
图1为根据本发明的实施方案的用于凝块的视觉检查和移除的基于脑血管导管的系统20的示意性图解。
由操作系统20的医师34保持的导管控制器手柄29连接到导管28的近侧端部。控制器手柄29允许医师在脑中推进并导航导管28，例如通过患者32的大腿动脉处的进入点22。医师34使用手柄29上的操作控件通过膨胀密封球囊并且通过使用密封片阻挡任何分叉来密封动脉的凝结区域，如下文所述。
接下来，医师操作泵送单元42以利用流过管道19a的盐水冲洗密封部分，该管道在近侧端部连接到泵送单元42并且在远侧端部经由手柄29中的阀连接到延伸穿过导管28的工作通道的近侧端部，如下文所述。
经由缆线19b发送来自导管28的电信号。管道19a和缆线19b包括在经由手柄29连接到导管28的缆线19中。医师随后利用装配在导管28的远侧端部处的相机来采集脑凝块的视觉图像44。将脑凝块的图像呈现在屏幕56上。在凝块可视化过程之后，并且基于这些图像，医师34评估凝块的物理特性并确定适当的治疗。
系统20的元件由系统处理器40控制。处理器40可安装在控制台46中，该控制台包括操作控件38，该操作控件通常包括小键盘和/或指向装置，诸如鼠标或轨迹球。处理器40使用存储在存储器中的软件来操作系统20。该软件可例如以电子形式通过网络下载到处理器40，或者可另选地或另外地，该软件可被提供和/或存储在非临时性有形介质诸如磁存储器、光学存储器或电子存储器上。
图1所示的系统完全是为了概念清晰而选择的。其他系统元件可包括例如基于磁导管的位置跟踪子系统，诸如如2018年5月24日提交的名称为“Position Sensor on BrainClot Sheath and Location Pad Collar”的美国临时专利申请62/675,952所述，该临时专利申请被转让给本专利的受让人并且其公开内容以引用方式并入本文。另选地或除此之外，可使用X射线荧光镜脑成像子系统。手柄29可包含附加元件，诸如阀和到达工作通道的进入点，以在轴中滑动，该轴在其远侧端部处装配有治疗装置，诸如凝块移除支架。
冲洗球囊导管以在血管分叉情况下观察和移除凝块
图2为根据本发明的实施方案的被配置成执行凝块50的视觉成像的导管28的远侧端部33的视图。在本示例中，远侧端部33包括相机60、密封球囊63和可移动式密封片67。一个或多个工作通道65延伸穿过导管。
如图所示，凝块50阻挡动脉52中的血流。医师34将导管28的远侧端部33导航并推进到足够靠近凝块50的位置，以使相机60采集凝块的视觉图像(在遮挡血液已被清除之后)。密封球囊63被示为已膨胀，从而在近侧密封相机60与凝块50之间的动脉容积55。
在一些情况下，如在图2中所见，动脉分叉66防止仅利用球囊63来形成密封的动脉容积55。在一些实施方案中，远侧端部33结合并且使用分叉密封元件，诸如可移动式密封片67，以封闭分叉66，以便防止经由分流动脉流入的新鲜血液遮挡凝块50。
在一些实施方案中，在密封片67与分叉66对准之后，利用可膨胀构件和/或弹性元件(未示出)或通过机械操纵(例如，通过使用从导管手柄控制的传送)来抵靠动脉壁挤压密封片67。工作通道65提供到达完全密封容积55的通路，从而允许医师34将盐水注入容积55内，以便冲洗遮挡血液并且使相机60采集凝块50的图像。
在一些实施方案中，在医师34已视觉检查凝块并且基于该视觉检查已确定凝块的物理特性之后，医师选择相应的治疗方法以消除凝块50。例如，如果凝块50被医师34确定为实体状，则医师34通过工作通道65推进凝块移除支架以抓紧并回缩凝块50。如果医师34确定凝块50为凝胶状，则医师34施加抽吸以抽出凝块50并且/或者通过工作通道65输注药物，以便溶解凝块50。
图2所示的示例性例证完全是为了概念清晰而选择的。图2仅示出了与本发明的实施方案相关的部件。例如，省略了导管元件，诸如用于分叉密封片67的部署和支撑机构的元件。在一些实施方案中，医师34初始利用动脉52的造影剂增强的X射线荧光镜成像来对分叉67成像。密封片67可由塑料诸如PET、聚苯乙烯或弹性体制成，并且可包括不透射线的标记物。
图3为根据本发明的实施方案示意性地示出用于使凝块可视化并相应地选择治疗的方法的流程图。该过程开始于在导管定位步骤70处，医师34定位导管28的远侧端部33以利用相机60视觉检查凝块50。接下来，在密封步骤72处，医师34通过膨胀球囊63并且在动脉分叉67的情况下通过另外地移动密封片67以阻挡分叉来密封动脉52的一部分(即，区域)。在盐水冲洗步骤74处，医师34使盐水流过工作通道65以从动脉52的密封部分清除血液。接下来，在凝块检查步骤76处，医师34操作相机60以采集凝块60的视觉图像。基于所采集的图像，医师34确定凝块50的物理特性，诸如其实体状或凝胶状结构。最后，在治疗方法选择步骤80处，基于所确定的凝块50的物理特性，医师34选择治疗方法以消除凝块50。例如，如果凝块为实体状，则医师可推进凝块移除支架以抓紧并回缩凝块。另一方面，如果凝块非常柔软，则医师可通过工作通道65施加抽吸，以便抽出凝块50。
图3所示的示例流程图完全是为了概念清晰而选择的。在另选的实施方案中，例如，基于得自相机60的指示，医师34可选择通过在凝结部位处输注药物来移除凝块。
应当理解，上述实施方案以举例的方式被引用，并且本发明不限于上文具体示出和描述的内容。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该变型和修改，并且该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 (7)

1.一种导管，包括：
轴，所述轴具有用于插入到患者的脑的凝结血管内的远侧端部；
密封球囊，所述密封球囊装配在所述远侧端部的近侧区段处，并且被配置成在近侧密封所述凝结血管的一部分；
分叉密封元件，所述分叉密封元件在所述密封球囊的远侧装配在所述远侧端部处，并且被配置成密封位于所述凝结血管的近侧密封部分处的分叉；和
相机，所述相机装配在所述远侧端部的远侧边缘处，并且被配置成对使所述血管凝结的凝块视觉成像。
2.根据权利要求1所述的导管，其中所述分叉密封元件包括可移动式密封板。
3.根据权利要求1所述的导管，其中所述远侧端部还包括被配置成抵靠所述分叉挤压所述分叉密封元件的可膨胀构件。
4.根据权利要求1所述的导管，其中所述远侧端部还包括被配置成抵靠所述分叉挤压所述分叉密封元件的弹性构件。
5.根据权利要求1所述的导管，还包括被配置成引导凝块移除装置的工作通道。
6.根据权利要求1所述的导管，还包括被配置成使流体流入所述近侧密封部分内的工作通道。
7.根据权利要求1所述的导管，还包括被配置成将抽吸低压输送到所述近侧密封部分内以便抽出所述凝块的工作通道。
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EP3653140B1 (en) 2021-10-27
BR102019021808A2 (pt) 2020-06-02
ES2900547T3 (es) 2022-03-17
JP2020081868A (ja) 2020-06-04
US20200155814A1 (en) 2020-05-21
KR20200058286A (ko) 2020-05-27
KR102770533B1 (ko) 2025-02-25

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