CN108472019A - 用于治疗中风的方法和装置 - Google Patents

用于治疗中风的方法和装置 Download PDF

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CN108472019A
CN108472019A CN201780005465.8A CN201780005465A CN108472019A CN 108472019 A CN108472019 A CN 108472019A CN 201780005465 A CN201780005465 A CN 201780005465A CN 108472019 A CN108472019 A CN 108472019A
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catheter
suction
infusion
shell
conduit
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P·阿南德
J·埃克赫姆
德普阿琼·辛格
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Alcyone Therapeutics Inc
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Alcyone Lifesciences Inc
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    • A—HUMAN NECESSITIES
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    • A61B17/3401—Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/77—Suction-irrigation systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A61M1/85—Drainage tubes; Aspiration tips with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22079—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with suction of debris
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2017/22082—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
    • A—HUMAN NECESSITIES
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    • A61B2017/22082—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
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    • A61B2017/22082—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
    • A61B2017/22088—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance ultrasound absorbing, drug activated by ultrasound
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0102—Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod

Abstract

本文公开了允许通过单个装置输注和抽吸的方法和装置。该装置可用于通过将装置输送至血凝块的部位并同时或顺序地将溶栓剂或其他药物输注至凝块并从患者抽吸溶解的凝块来治疗中风。该方法和装置可以有利地允许更有效的溶栓剂输注和凝块抽吸。还公开了模块化系统，以及治疗硬膜下血肿或其他病症的方法。

Description

用于治疗中风的方法和装置
相关申请的交叉引用
本申请要求于2016年1月4日提交的标题为“METHODS AND DEVICES FOR TREATINGSTROKE”的美国临时申请No.62/274,582的优先权，其全部内容通过引用包含于此。
技术领域
本文公开了用于将药物输送至受试者并且用于从受试者抽吸物质(例如用于治疗中风)的方法和装置。
背景技术
每年有数以百万计的人受到中风的影响，并且中风是导致残疾和死亡的重要原因。早期有效的治疗可以减少中风造成的损害。然而，现有的中风治疗可能并不理想。例如，一种治疗方法是将脑室引流管插入患者的大脑中以缓解压力并排出由于中风而积聚在大脑中的血液。可以将诸如组织纤溶酶原激活剂(tPA)的溶栓剂给予患者，以帮助分解血凝块并使凝块排出。这种治疗方法要求溶栓剂非常缓慢地输送，并且引流管必须长时间留置在患者体内(例如，许多小时或数天)，这延长了在手术或重症监护室中花费的时间并导致不理想的患者结果。一直需要一种用于治疗中风的改善的方法和装置。
发明内容
本文公开了允许通过单个装置输注和抽吸的方法和装置。该装置可用于通过将装置输送至血凝块的部位并同时或顺序地将溶栓剂或其他药物输注至凝块并从患者抽吸溶解的凝块来治疗中风。该方法和装置可以有利地允许更有效的溶栓输注和凝块抽吸。还公开了模块化系统，以及治疗硬膜下血肿或其他病症的方法。
在一些实施例中，导管系统包括具有输注管腔和至少一个出口的输注导管；以及具有抽吸管腔和至少一个抽吸口的抽吸导管，所述抽吸导管限定所述输注导管可滑动地设置在其中的通道。
抽吸导管可以限定弹头特征。该系统可以包括可移除地定位在输注导管的输注管腔中的插入管心针。该系统可以包括TRA系统。TRA系统可以包括设置在输注导管的远端中的水听器或麦克风、从水听器或麦克风延伸到输注导管的近端的一个或多个引线、以及被配置为时间反演由水听器或麦克风检测到的信号并基于时间反演信号发射声波的混响器。抽吸导管可以包括第一和第二操纵线，张力可以被施加至第一和第二操纵线以远程操纵抽吸导管的远端。抽吸管腔可以包括第一抽吸管腔和第二抽吸管腔，每个抽吸管腔都具有C形横截面。
在一些实施例中，治疗患者的方法包括将导管系统推进到患者体内的治疗部位；通过导管系统的输注导管将药物和冲洗流体中的至少一种输送到治疗部位；相对于输注导管向远侧推进导管系统的抽吸导管；以及通过抽吸导管的抽吸管腔从治疗部位抽吸物质。
治疗部位可以包括患者的脑中的凝块。该药物可以包括溶栓剂。抽吸的物质可以包括凝块物质。抽吸物质可以包括在治疗部位内操纵抽吸导管。输送药物可以包括通过向治疗部位施加声能来增强药物的扩散速率。输送药物可以包括使用声能来控制分配药物的方向。声能可以从TRA系统发射。
在一些实施例中，模块化导管系统包括抽吸导管，抽吸导管具有其中形成有抽吸口的近侧抽吸外壳；输注导管，所述输注导管可滑动地设置在所述抽吸导管内并且具有其中形成有输注口的近侧输注外壳；以及盖外壳，其被配置成选择性地耦接到抽吸外壳和输注外壳中的任一个。
该系统可以包括具有近侧插入外壳的插入管心针，所述近侧插入外壳被配置成选择性地耦接到输注外壳。抽吸外壳和输注外壳可以限定导管模块，并且系统可以包括手动控制模块，该手动控制模块被配置为选择性地耦接到导管模块。手动控制模块可以包括用于相对于抽吸导管推进或缩回输注导管的控件。手动控制模块可以包括用于操纵抽吸导管的控件。抽吸外壳和输注外壳可以限定导管模块，并且系统可以包括立体定向模块，其被配置为选择性地耦接到导管模块。立体定向模块可以包括用于将立体定向模块附接到立体定向框架的配合特征。立体定向模块可以包括用于使输注导管相对于抽吸导管前进或缩回的第一控件和用于操纵抽吸导管的第二控件。
附图说明
结合附图提供以下详细描述，其中：
图1是以组装形式示出并具有额外的输注管腔和插入管心针的示例性导管系统的透视图；
图2是以分解和组装构造并与TRA模块示出的图1的导管系统的透视图；
图3A是图1的导管系统的远端的放大透视图和放大截面图；
图3B是图1的导管系统的近端的放大透视图；
图3C是图1的导管系统的近端的放大分解图；
图4A是凝块的示意图；
图4B是图4A的凝块的示意图，其中图1的导管系统插入至凝块中；
图4C是图4A的凝块的示意图，其中图1的导管系统将流体输注至凝块中；
图4D是图4A的凝块的示意图，其中图1的导管系统将超声能量施加至凝块；
图4E是通过图1的导管系统抽吸的图4A的凝块的示意图；
图5A是以分解状态并与TRA模块示出的示例性模块化导管系统的透视图；
图5B是在第一组装布置中的图5A的系统的透视图；
图5C是在第二组装布置中的图5A的系统的透视图；
图5D是在第三组装布置中的图5A的系统的透视图；
图5E是图5A的系统的导管组件和手动控制模块的透视图；
图5F是图5A的系统的导管组件和立体定向模块的透视图；
图6A是用于治疗具有血肿的患者的图5A的系统的示意图；
图6B是图6A的血肿的示意图，其中图5A的导管系统插入血肿中；
图6C是图6A的血肿的示意图，其中图5A的导管系统将流体输注至血肿中；
图6D是图6A的血肿的示意图，其中图5A的导管系统将超声能量施加至血肿；以及
图6E是通过图5A的导管系统抽吸的图6A的血肿的示意图。
具体实施方式
本文公开了允许通过单个装置输注和抽吸的方法和装置。该装置可用于通过将装置输送至血凝块的部位并同时或顺序地将溶栓剂或其他药物输注至凝块并从患者抽吸溶解的凝块来治疗中风。该方法和装置可以有利地允许更有效的溶栓剂输注和凝块抽吸。还公开了模块化系统，以及治疗硬脑膜下血肿或其他病症的方法。
现在将描述某些示例性实施例以提供对本文公开的系统和方法的结构、功能、制造和使用的原理的全面理解。在附图中示出了这些实施例的一个或多个示例。本领域的技术人员将会理解，在此具体描述并在附图中示出的系统和方法是非限制性的示例性实施例。结合一个示例性实施例示出或描述的特征可以与其他实施例的特征组合。这样的修改和变化旨在被包括在本公开的范围内。
图1-3C示出了导管系统100的示例性实施例。如图所示，系统100可以包括抽吸导管102和输注导管104。系统100还可以包括可移除的插入管心针106。
系统100可以包括时间反演声学(TRA)模块108或用于聚焦声能(例如，超声能量)的其他装置以增强或控制输注。在示例性TRA系统中，导管远端处的水听器测量药物输送部位处的声学信号。感测到的声学信号通过有线或无线接口传送到时间反演声学信号的处理器或电路。然后使用时间反演的声学信号来驱动放置在患者体外的混响器。由混响器施加的声能可用于增强或加速药物的输注和/或控制药物输注的方向。有关TRA和药物输送的更多细节可以在通过引用包含于此的OLBRICHT,W.等,TIME-REVERSAL ACOUSTICS ANDULTRASOUND-ASSISTED CONVECTION-ENHANCED DRUG DELIVERY TO THE BRAIN,J AcoustSoc Am.2013Aug；134(2):1569-75中找到。
如图2所示，插入管心针106可以通过输注导管104的管腔插入，并且输注导管和管心针可以通过抽吸导管102的管腔插入。
参考图3A，输注导管104可以包括限定中央流体管腔110的细长管状主体。输注导管104可以包括一个或多个流体出口112，其可以在导管上的多个位置中的任何位置处形成。在所示实施例中，流体出口112形成在导管104的横向侧壁中。导管104可包括邻近其远端形成的第一和第二直径相对的侧出口流体出口112。输注导管104可以包括一个或多个不透射线标记114以便于在外科手术期间例如经由荧光镜、CT、MRI或PET成像的可视化。MEMS水听器或微型水听器116可以设置在输注导管104的远端附近，用于检测用于在上述TRA系统108中使用的声学信号。用于将检测到的声学信号传送到导管104的近端和TRA系统108的其他部件的一个或多个电引线118可以嵌入输注导管104的侧壁中或者穿过导管的中央管腔110。
还如图3A所示，抽吸导管102可以包括细长管状主体，该细长管状主体限定中央管腔120，输注导管104布置在中央管腔120中。输注导管104可以在中央管腔120内相对于抽吸导管102纵向平移。抽吸导管102可以包括一个或多个抽吸管腔122，溶解的凝块或其他物质可以通过该抽吸管腔122从治疗部位提取。在所示实施例中，抽吸导管102包括设置在中央管腔120的任一侧上的具有C形横截面的第一和第二抽吸管腔122。可以理解，抽吸管腔122可以具有各种其他形状和构造中的任一种。抽吸管腔122可以经由一个或多个抽吸口124与抽吸导管102的外部流体连通，抽吸口124可以如图所示形成在抽吸导管的横向侧壁中。
抽吸导管102可以包括一个或多个不透射线标记126，以便于在外科手术期间的可视化。抽吸导管102的远端可以具有锥形、倾斜或凸起形状128，其提供从较大外径的抽吸导管到较小外径的输注导管104的逐渐过渡。该形状可以有利地与系统100插入其中的周围组织形成密封，以防止输注物沿着导管102、104的插入轨道的回流，并且由此基本上将输注的药物容纳到输注导管的远端及其大致的附近。系统100可以包括用于减少或防止回流的其他特征，例如限定组织接收空间的外套管，其被配置为夹紧组织并且与其形成密封，例如如题为“SYSTEMS AND METHODS FOR REDUCING OR PREVENTING BACKFLOW IN A DELIVERYSYSTEM”的美国专利No.8,992,458中所公开的，其通过引用包含于此。该参考文献中还公开了示例性的弹头特征。
抽吸导管102可以包括用于远程操纵治疗部位内的导管的远端的机构。在所示实施例中，抽吸导管102包括嵌入导管的侧壁中的第一和第二直径相对的操纵线130。张力可以施加到布置在患者外部的操纵线130的近端，以操纵在治疗部位内的导管102的远端。
抽吸导管102可以包括抽吸口132，导管可以通过抽吸口132连接到真空泵或其他抽吸源。系统100可以包括用于操作系统的各种控件134。例如，如图3B-3C所示，系统可以包括第一旋钮134A，第一旋钮134A被配置为控制输注导管104相对于抽吸导管102的延伸和缩回。第一旋钮134A可以耦接到摩擦地接合或以其他方式机械地接合输注导管104的轮以使得旋钮134A的旋转引起输注导管104相对于抽吸导管102纵向平移。可替换地，如图所示，第一旋钮134A可以与可滑动地安装到抽吸导管102的外壳144的梁148接合。梁148的近侧部分可选择性地附接到输注导管104的安装主体150。例如，梁148可包括被配置成围绕安装主体150适配的C形夹具156。夹具156可以包括与安装主体150的相应凹槽160接合的相对的脊部158，以将夹具可释放地保持到安装主体。脊部158和凹槽160可以被锁住，以使得当脊部和凹槽配合时防止夹具156和安装主体150之间的相对纵向移动。可以理解的是，脊部和凹槽可以互换，例如以使得凹槽形成在夹具156中，并且脊部形成在安装主体150中。第一旋钮134A的旋转可以有效地平移梁148，并且安装主体150和输注导管104通过相对于抽吸导管102纵向延伸以相对于抽吸导管推进或缩回输注导管。输注导管104的安装主体150可以包括用于在水听器116与TRA系统108之间建立电、声和/或光学连接的连接器152。
系统100可以包括被配置成控制抽吸导管102的操纵的第二旋钮134B。可以旋转第二旋钮134B以选择性地向操纵线130施加张力以操纵抽吸导管102。系统还可以包括控件，以用于选择性地和/或单独地将抽吸应用到第一和第二抽吸管腔122。
如图1-2所示的可移除插入管心针可以选择性地定位在输注导管104的中央管腔110内以便于导管系统100的插入和瞄准。管心针106可以在其近端包括附接盖142。盖142可以便于使用者抓住管心针106，并且可以用于例如经由在输注导管的近侧输注口154周围或附近形成的螺纹或搭扣配合耦接来将管心针附接到输注导管104或抽吸导管102。
抽吸导管102的近端可以包括主体或外壳144。外壳144可以包括安装块146以便于将外壳附接到立体定向框架。
图4A-4E示出了使用系统100将药物输送给患者并从患者移除凝块例如以治疗中风的示例性方法。
如图4A所示，凝块或出血的部位136可以位于患者体内(例如，在患者的脑内)并且可以规划对该部位的立体定向方法。
然后可以例如使用立体定向导航将导管系统100引导至部位136，如图4B所示。一旦在部位处或在任何其他期望的时间，插入管心针106可以从导管系统100移除。
如图4C所示，药物138可以通过输注导管104输注到目标部位136。本文使用的术语“药物”是指可以输送给人或动物患者的任何功能剂，包括激素、干细胞、基因治疗剂、化学药品、化合物、小分子和大分子、染料、抗体、病毒、治疗剂等。药物可以是或可以包括溶栓剂(例如tPA)。可替换地或另外地，可以通过输注导管104输送诸如生理盐水的冲洗流体。
当药物138通过输注导管104输注时，TRA模块108可以被致动以将聚焦声能140输送到目标部位136并且由此在整个凝块中快速扩散药物138和/或控制药物扩散的方向，如图4D所示。
如图4E所示，抽吸导管102可在输注导管104上向远侧推进并进入凝块136，以在凝块物质溶解时抽吸凝块物质。抽吸导管102的远端可以在治疗部位136内被操纵，以确保所有凝块物质被抽吸。例如，抽吸导管120的操纵线130可以被致动以在治疗部位136内来回扫描导管尖端。可以将冲洗流体输送至治疗部位136以冲出凝块物质。一旦凝块被移除，或者在任何其他期望的时间，系统100可以从患者移除。如下面所讨论的，系统的一个或多个部件(例如抽吸导管102)可以保留就位以便在数小时、数天或数周的时间内长期引流。
在一些实施例中，系统的一个或多个部件可以是模块化的。模块化导管系统可以适应各种不同的工作流程。例如，可以使用管心针、输注和抽吸组件来放置导管，然后可以移除管心针并且端部加盖以用于输注/冲洗和TRA超声波，然后可以移除输注模块，留下紧凑的引流模块以在必要或需要的情况下用于长期引流。
图5A-5F示出了示例性模块化导管系统200。除了在此描述的以及本领域普通技术人员将容易理解的，图5A-5F的导管系统200可以基本上类似于上述的导管系统100。因此，图5A-5F的导管系统的结构和功能的详细描述在此为了简洁起见而省略。
参考图5A，系统200可以包括抽吸导管202和输注导管204。系统200可以包括可通过导管202、204插入的管心针206，以便于将系统插入患者体内。系统200可以包括盖262以例如当管心针206或输注导管204被移除时封闭系统的近端。该系统可以包括一个或多个颅骨锚固器或导管导引件264，用于将系统固定到患者或用于引导导管。系统200可以包括手动控制模块266，以提供系统控件的单手的灵巧操作，提供高效的手动引导程序。系统200可以包括低轮廓立体定向模块268，以提供用于集成到立体定向导航系统的紧凑平台中的控件。系统200可以包括用于聚焦声能(例如，超声能量)以增强或控制输注的TRA模块208或其他装置。
如图所示，同轴管心针206、输注导管204和抽吸导管202可以与系统100中的基本相同。然而，在系统200中，每个导管的近端终止于模块化筒式外壳，其基于给定治疗的需求允许系统的功能元件的不同组合。例如，系统200可以允许使用者在初始治疗程序之后将抽吸导管留在适当位置用于持续引流。模块化筒式外壳可以采用多种形式。所示实施例示出了扁平的圆角矩形形状，但是也可以替代地或附加地使用其他形状，例如圆柱形设计。
在延长的引流情况下，一旦溶栓剂的初始输注和TRA超声扩散完成，或者在任何其他期望时间，输注导管204可以被完全移除，并且抽吸导管202的近端例如使用盖262封闭，以使得抽吸导管可以保持就位。在被封闭时，近端可比完整的导管系统更紧凑，进一步便于延长植入。另外，抽吸导管202的中心孔可以在该构造中提供额外的引流路径。
系统200可以包括可移除的手动和/或立体定向控件，其可以进一步便于延长植入。将控件封装在可移除模块上可以允许模块化“筒”尽可能紧凑，并且还可以允许当移除控件时锁定各种导管功能(例如，操纵性和输注导管前进/缩回)。这可以防止在延长植入期间意外启动这些功能中的任何一个。
图5B示出了系统200的第一布置，其中管心针206插入穿过输注导管204，输注导管204被插入穿过抽吸导管202。近侧管心针盖或外壳242可定位为邻近近侧输注导管外壳250，近侧输注导管外壳250可以邻近近侧抽吸导管外壳244定位。外壳242、250、244可以是模块化的筒，其可以例如经由卡扣配合或其它连接选择性地相互配合。抽吸导管外壳244可以包括抽吸口232。输注导管外壳250可以包括输注口254。输注导管外壳250可以包括用于TRA系统208的连接器252。图5B的布置可以用于系统200在患者体内的初始放置。
图5C示出了系统200的第二布置，除了管心针206被移除之外，其可以与第一布置相同。管心针外壳242可以用盖262来代替。图5C的布置可用于抽吸和/或输注。
图5D示出了系统200的第三布置，除了输注导管204被移除之外，其可以与第二布置相同。输注导管外壳250可以用盖262来代替。图5D的布置可以用于抽吸，例如作为用于长期引流的紧凑引流组件。这种布置也可以用于输注，例如通过将流体输注通过抽吸导管202的抽吸管腔。
图5E示出了以下构造的系统200，其中导管组件的模块化筒(例如，管心针206、输注导管204和抽吸导管202中的一个或多个)耦接到手动控制模块266。手动控制模块266可以提供系统控件的单手的灵巧操作，提供高效的手动引导程序。手动控制模块266可包括人体工学手柄270，例如手枪式握把的手柄、铅笔式手柄等。手动控制模块266可包括释放按钮272，释放按钮272可被致动以将导管组件274从手动控制模块266释放。手动控制模块266可以包括一个或多个控件276，用于控制导管组件274的操作。例如，手动控制模块266可以包括滑动杆、旋钮、可推动按钮或其他控制特征，用于使输注导管204相对于抽吸导管202前进或缩回，或用于操纵导管202、204中的一个或两个。控件276可以以与上述旋钮134A、134B类似的方式操作。
图5F示出了以下构造的系统200，其中导管组件的模块化筒(例如，管心针206、输注导管204和抽吸导管202中的一个或多个)耦接到低轮廓立体定向模块268。立体定向模块268可以提供用于集成到立体定向导航系统中的紧凑平台中的控件。立体定向模块268可以包括释放按钮278，释放按钮278可以被致动以从立体定向模块268释放导管组件274。立体定向模块268可以包括用于控制导管组件274的操作的一个或多个控件280。例如，立体定向模块268可以包括用于相对于抽吸导管202推进或缩回输注导管204或用于操纵导管202、204中的一个或两个的滑动杆、旋钮、可推动按钮或其他控制特征。控件280可以以类似于上述旋钮134A、134B的方式操作。在所示实施例中，立体定向模块268包括用于操纵抽吸导管202的前部控制旋钮280A和用于相对于抽吸导管202推进或缩回输注导管204的后部控制旋钮280B。立体定向模块268可以包括附接特征，其被配置为将系统200附接到立体定向框架或引导系统。例如，如图所示，立体定向模块268可以包括用于集成到立体定向系统中的燕尾安装块282。
图6A-6E示出使用导管系统(例如，本文公开的系统100或系统200)来治疗诸如硬膜下血肿的血肿的示例性方法。
如图6A所示，可以例如通过在血肿位置上执行麻花钻开颅术进入血肿284的部位。可以安装颅骨锚264，并且可以将导管系统200通过颅骨锚进给到硬膜下腔。
如图6B所示，操纵功能可用于将导管系统200的远端引导至血肿284内的位置。
如图6C所示，输注/冲洗导管204可从抽吸导管202向远侧延伸并进入血肿284。溶栓剂或其他药物286的冲洗和/或输注可通过导管204进行。
如图6D所示，聚焦超声288可以例如使用TRA系统208被施加到血肿284来扩散冲洗流体和/或药物并分解血肿。
如图6E所示，输注导管204可以被缩回和/或抽吸导管202可以前进以抽吸血肿。操纵功能可用于定位需要抽吸的区域。
尽管在本文中通常考虑用于从脑中移除凝块以用于治疗中风的程序中的用途，但应理解，本文的方法和装置可用于各种其他医疗或非医疗程序中的任一种。例如，本文的方法和装置可用于从人类或动物患者的任何位置溶解和/或移除任何类型的组织，并且可用于治疗除中风之外的各种疾病。
应该注意的是，在以上描述中或附图中表达或暗示的方法步骤的任何排序不应被解释为将所公开的方法限制为以该顺序执行步骤。而是，本文公开的每种方法的各个步骤可以以各种顺序中的任何一种进行。另外，由于所描述的方法仅仅是示例性实施例，包括附加步骤或包括更少步骤的各种其他方法也在本公开的范围内。
尽管已经通过参考具体实施例描述了本发明，但应该理解的是，可以在所描述的发明构思的精神和范围内做出许多改变。因此，意图是本发明不限于所描述的实施例。

Claims (23)

1.一种导管系统，包括：
输注导管，其具有输注管腔和至少一个出口；以及
抽吸导管，其具有抽吸管腔和至少一个抽吸口，所述抽吸导管限定了所述输注导管可滑动地设置在其中的通道。
2.根据权利要求1所述的系统，其中所述抽吸导管限定弹头特征。
3.根据权利要求1所述的系统，还包括可移除地定位在所述输注导管的输注管腔中的插入管心针。
4.根据权利要求1所述的系统，还包括TRA系统。
5.根据权利要求4所述的系统，其中所述TRA系统包括设置在所述输注导管的远端中的水听器或麦克风、从所述水听器或麦克风延伸到所述输注导管的近端的一个或多个引线、以及被配置为时间反演由所述水听器或麦克风检测到的信号并基于时间反演信号发射声波的混响器。
6.根据权利要求1所述的系统，其中所述抽吸导管包括第一和第二操纵线，张力能够被施加至所述第一和第二操纵线以远程操纵所述抽吸导管的远端。
7.根据权利要求1所述的系统，其中所述抽吸管腔包括第一抽吸管腔和第二抽吸管腔，每个抽吸管腔具有C形横截面。
8.一种治疗患者的方法，包括：
将导管系统推进到患者体内的治疗部位；
通过所述导管系统的输注导管将药物和冲洗流体中的至少一种输送到所述治疗部位；
相对于所述输注导管向远侧推进所述导管系统的抽吸导管；以及
通过所述抽吸导管的抽吸管腔从所述治疗部位抽吸物质。
9.根据权利要求8所述的方法，其中所述治疗部位包括所述患者的脑中的凝块。
10.根据权利要求8所述的方法，其中所述药物包含溶栓剂。
11.根据权利要求8所述的方法，其中所抽吸的物质包括凝块物质。
12.根据权利要求8所述的方法，其中抽吸所述物质包括操纵在所述治疗部位内的所述抽吸导管。
13.根据权利要求8所述的方法，其中输送所述药物包括通过向所述治疗部位施加声能来增加所述药物的扩散速率。
14.根据权利要求8所述的方法，其中输送所述药物包括使用声能控制分配所述药物的方向。
15.根据权利要求13所述的方法，其中所述声能从TRA系统发射。
16.一种模块化导管系统，包括：
抽吸导管，其具有在其中形成有抽吸口的近端抽吸外壳；
输注导管，所述输注导管可滑动地设置在所述抽吸导管内并且具有其中形成有输注口的近侧输注外壳；以及
盖外壳，其被配置为选择性地耦接到所述抽吸外壳和所述输注外壳中的任一个。
17.根据权利要求16所述的系统，还包括具有近侧插入外壳的插入管心针，所述近侧插入外壳被配置成选择性地耦接到所述输注外壳。
18.根据权利要求16所述的系统，其中所述抽吸外壳和所述输注外壳限定导管模块，并且其中所述系统包括手动控制模块，所述手动控制模块被配置为选择性地耦接到所述导管模块。
19.根据权利要求18所述的系统，其中所述手动控制模块包括用于相对于所述抽吸导管推进或缩回所述输注导管的控件。
20.根据权利要求18所述的系统，其中所述手动控制模块包括用于操纵所述抽吸导管的控件。
21.根据权利要求16所述的系统，其中所述抽吸外壳和所述输注外壳限定导管模块，并且其中所述系统包括立体定向模块，所述立体定向模块被配置为选择性地耦接到所述导管模块。
22.根据权利要求21所述的系统，其中所述立体定向模块包括用于将所述立体定向模块附接到立体定向框架的配合特征。
23.根据权利要求21所述的系统，其中所述立体定向模块包括用于使所述输注导管相对于所述抽吸导管前进或缩回的第一控件和用于操纵所述抽吸导管的第二控件。
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US10531882B2 (en) 2020-01-14
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