CN106232168A - 吸取监控系统和方法 - Google Patents
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Abstract
在一个实施方式中,一种用于实时监控导管吸取的系统包括:外壳,其具有适于连接至真空源的第一端口和适于与吸取导管连接的第二端口;压力传感器,其与外壳的内部流体连通;测量装置,其耦接至压力传感器并配置成测量流体压力偏差;以及通信装置,其耦接至测量装置并配置成当测量装置测量的流体压力偏差超过预设阈值时生成警报信号。在另一个实施方式中,用于实时监控导管吸取的系统进一步包括真空源,其用于连接至第一端口的真空源;以及吸取导管,其具有用于连接至第二端口的吸取管腔。
Description
技术领域
本发明的领域通常涉及通过吸取从人体的流体运输腔、管道或管腔(例如,血管)移除不希望有的物质(例如血栓(thrombosis))的吸取系统。
背景技术
用于从患者血管内移除不希望有的物质(例如血栓)的治疗方法包括使用具有细长轴的吸取导管,该细长轴形成有在其内延伸的吸取管腔。吸取导管也可包括用于放置导丝的导丝管腔,导丝用于将吸取导管引导至人体的目标部位。通过利用例如注射器(其具有连接至吸取导管近端的座)对吸取管腔的近端施加真空(即负压力),物质可被吸入吸取导管远端的吸取端口,进入吸取管腔,从而从患者体内移除。
发明内容
在一个实施方式中,一种用于实时监控导管吸取的系统包括:真空源;吸取导管,其具有吸取管腔;外壳,其具有构造成耦合至真空源的第一端口和构造成耦接至吸取导管的吸取管腔的第二端口;压力传感器,其与外壳内部流体连通;测量装置,其耦接至压力传感器并配置成测量流体压力偏差;和通信装置,其耦接至测量装置并配置成当测量装置测量的流体压力偏差超过预设阈值时生成警报信号。
在另一个实施方式中,一种用于实时监控导管吸取的系统包括:外壳,其具有适于可拆卸地连接至真空源的第一端口和适于与吸取导管可拆卸地连接的第二端口;压力传感器,其与外壳内部流体连通;测量装置,其耦接至压力传感器并配置成测量流体压力偏差;和通信装置,其耦接至测量装置并配置成当测量装置测量的流体压力偏差超过预设阈值时生成警报信号。
在另一个实施方式中,一种用于实时监控导管吸取的方法,包括以下步骤:将具有吸取管腔的吸取导管插入患者;提供用于实时监控导管吸取的系统,系统包括外壳,其具有适于可拆卸地连接至真空源的第一端口和适于与吸取导管的吸取管腔可拆卸地连接的第二端口;压力传感器,其与外壳内部流体连通;测量装置,其耦接至压力传感器并配置成测量流体压力偏差;和通信装置,其耦接至测量装置并配置成当测量装置测量的流体压力偏差超过预设阈值时生成警报信号;将第一端口耦接至真空源:将第二端口耦接至吸取导管的吸取管腔:以及使得或允许通过吸取导管的吸取管腔吸取体液,其中测量装置在吸取体液期间测量流体压力,且其中在吸取体液期间,当一个或多个测量的流体压力偏差超过预设阈值时,通信装置生成警报信号。
附图说明
图1是根据实施方式的吸取系统的平面图。
图2A是根据第一实施方式的吸取监控系统的视图。
图2B是根据第二实施方式的吸取监控系统的视图。
图3是根据第三实施方式的吸取监控系统的视图。
图4A是血管中的吸取导管在与血栓接触之前的剖面图。
图4B是血管中的吸取导管与血栓接触时的剖面图。
图4C是吸取导管在失去真空期间的剖面图。
图4D是血栓被吸取穿过吸取导管的剖面图。
图5A是图4A中的情况的压力与时间的关系的图示。
图5B是图4B中的情况的压力与时间的关系的图示。
图5C是图4C中的情况的压力与时间的关系的图示。
图5D是图4D中的情况的压力与时间的关系的图示。
具体实施方式
本发明涉及吸取导管系统的监控、警告和通信系统。吸取导管被例如大块血栓阻塞是使用者都关心的问题。避免物质在导管内阻塞/堵塞的技术常常包括快速强力地推进吸取导管,或轻轻拉拽血栓的边缘以确保一次仅引入小块或一小部分,所述的小块很小不足以阻塞或使吸取管腔闭塞。当装置在使用期间发生阻塞时,下游血栓意外移动的可能性会增大;将此称为远端栓塞。由于这种类型的吸取过程常常用于高技术性紧急情况,因此在吸取期间为使用者进行吸取导管早期阻塞检测可有助于手术成功和得出临床结果。据一些来源报道称,使用期间有高达50%的吸取导管会发生阻塞。
此外,使用者很难确定系统内是否已失去了真空,例如这是因为注射器(或其它真空源)充满流体或因为系统泄漏。血液相对不透明,且可覆于注射器的壁上,从而导致难以确定注射器何时充满。这使得很难确定是否对吸取导管施加了足够的真空。也很难确定系统是否存在漏气,漏气是失去真空的另一个原因,即便是在注射器充满吸取的流体之前。
在利用吸取导管吸取血栓期间,很难识别何时正在积极地吸取血栓,而何时仅正在吸取血液。由于保持正常血量和血压很重要,因此通常不希望从血管中吸取大量正常血液。然而,当跟踪吸取导管的位于血栓附近的尖端时,很难知道吸取导管是否已与血栓积极接合,吸取导管是否已吸取了至少部分血栓,或吸取导管是否未与血栓接合,而是仅正在吸取血液。因此,使用吸取导管可能效率低下,且导致比预期更多的血液被移除,从而导致使用者的治疗时间长度最短化,且在严重情况下需要输血。吸取的正常血液的量增加还意味着真空源(例如注射器)将在更短的时间内充满,因此需要更频繁地更换真空源。如果真空压力不足,则可发生远端栓塞,然而使用者并不知情。
图1图示了吸取系统2,其构造成允许对导管吸取进行实时监控。吸取系统2包括吸取导管4、真空源6、阀8、延伸管10和包括内嵌式压力换能器12的吸取监控系统48。吸取导管4具有近端14和远端16以及从近端14延伸至远端16的吸取管腔18。吸取管腔18的尺寸可设计成用于吸取血栓,在一些实施方式中,其内径可在大约0.38毫米(0.015英寸)至大约2.54毫米(0.100英寸)之间。吸取导管4的近端包括座(hub,毂状件)20,该座可包括凹鲁尔连接器22。吸取导管4的远端16的吸取管腔18可包括有角度孔口24,孔口24有助于跟踪穿过迂曲或堵塞的脉管系统。在一些实施方式中,导丝管腔26耦接至吸取导管4的远端16,并构造成沿导丝28进行跟踪。真空源6可包括注射器,且其尺寸可在5ml至100ml之间,或在20ml至60ml之间。真空源6可包括由美国犹他州盐湖城的MeritMedical公司制造的注射器。真空源6可包括筒体30和带有锁定件34的柱塞32,锁定件34构造成例如当沿D方向拉回柱塞以在筒体30内形成负压力(真空)时,使柱塞32相对于筒体30保持在适当位置。在一些实施方式中,真空源6可包括任何其它类型的可抽空容器,或可包括真空泵。真空源6经由延伸管10和阀8连接至吸取导管4的吸取管腔18。在一些实施方式中,真空源6可直接连接至吸取导管4的吸取管腔18。图1示出了凸鲁尔连接器36和凹鲁尔连接器38。阀8可以是标准双向旋塞阀,如图所示。
吸取监控系统48的压力换能器12构造成流体耦接于真空源6与吸取导管4之间。在图2A中,图示的吸取监控系统48为第一实施方式的独立装置。压力换能器12包括外壳40,外壳具有在第一端口44与第二端口46之间延伸的腔42。在一些实施方式中,第一端口44包括凹鲁尔接口,第二端口46包括凸鲁尔接口。在一些实施方式中,第一端口44包括凹鲁尔锁定件,第二端口46包括凸鲁尔锁定件,其每一个均可与特性相反的相应鲁尔锁定件附接并拆开。第一端口44构造成耦接至真空源6,二者直接耦接,或二者之间连接有阀8和/或延伸管10。第二端口46构造成耦接至吸取导管4的吸取管腔18,例如通过将第二端口46直接或间接耦接至吸取导管4的座20来实现。当利用吸取系统2吸取体液和/或物质(例如,血液和/或血栓)时,体液和/或物质通过吸取导管的吸取管腔18从远端的有角度孔口24被吸取至近端14的凹鲁尔连接器22,然后首先穿过压力换能器12的第二端口46,穿过腔42,然后穿过第一端口44。根据真空源6施加的真空(负压力)的量以及流动阻力的量和沿吸取系统2产生的压降,腔42内的压力将发生变化。例如,粘度更高的流体(如血液)或具有固体、半固体或凝胶状颗粒或部分的流体穿过吸取导管4的相对较小的吸取管腔18所产生的流动阻力将大于水或生理盐水溶液将会产生的流动阻力。因此,随着吸取管腔18内的流动阻力的增大,压力换能器12的腔42内的压力将减小(真空量将增大)。
为了进行定义,当说到真空量时,例如-15,000帕(-2.18磅每平方英寸,或psi)的压力与-10,000帕(-1.45psi)的压力相比是“更大的真空”。此外,与-10,000帕相比,-15,000帕为“更低压力”。此外,由于-15,000的绝对值大于-10,000的绝对值,因此,-15,000帕的“绝对真空压力”大于-10,000帕的绝对真空压力。在图2A中,外壳40的腔42内设有真空传感器50,真空传感器50与穿过腔42的流体是流体连通的。真空传感器50可以是标准压力传感器或换能器,包括主要为测量正压力而设计的压力传感器。其可使用本领域已知的任何类型的压力感测技术,包括MEMS技术。在一些实施方式中,真空传感器50构造成其准确性和/或精度在大约0帕至大约-101,325帕(-14.70psi),或在大约-45,000帕(-6.53psi)至大约-90,000帕(-13.05psi),或在大约-83,737帕(-12psi)至大约-96,527帕(-14psi)的压力范围内最高。在一些实施方式中,真空传感器的电源要求可在2.5伏DC至10伏DC的范围内。在一些实施方式中,真空传感器50可以是具有输出电压的模拟计量器。在图2A的独立实施方式中,真空传感器50由一个或多个电池52供电。基于真空传感器50的电源要求以及本文描述的吸取监控系统48的其它组件的电源要求,在一些实施方式中,一个或多个电池52可在1.5伏至9伏的范围内。外壳内还容纳有测量装置54,在一些实施方式中,测量装置54可包括微处理器。测量装置54耦接至真空传感器50,并从真空传感器50接收指示实时测量压力的信号。在一些实施方式中,测量装置54包括存储模块56,其内存储有测量装置54可用于例如计算的信息。
吸取监控系统48内包括耦接至测量装置54的一个或多个通信装置58a、58b、58c。一个或多个通信装置58a-c的每一个配置成至少部分地响应于测量装置54的活动和输出生成一种包括警报信号60a-c的警报。在一些实施方式中,通信装置58a可包括一个或多个LED(发光二极管),LED配置成通过可见警报信号60a生成可见警报,例如连续发出或以闪烁模式发出的光。在一些实施方式中,可使用除LED之外的灯。在一些实施方式中,通信装置58b可包括一个或多个振动发生器,振动发生器配置成通过触觉警报信号60b生成触觉警报,可包括但不限于振动或加热。在一些实施方式中,振动发生器可包括压电装置,压电装置配置成当施加电压时振动。在一些实施方式中,通信装置58c可包括一个或多个声音生成装置,声音生成装置配置成通过可听警报信号60c生成可听警报,例如连续噪音或重复噪音。在一些实施方式中,声音生成装置可包括蜂鸣器,蜂鸣器配置成当施加电压时发出一个或多个可听音调。在一些实施方式中,压电装置(例如结合通信装置58b描述的压电装置)也可用作作为通信装置58c的声音生成装置。
吸取系统2的使用者可能想要得到使用吸取系统2期间可能发生的几种情况的通知。这些可能的情况包括但不限于阻塞、由于真空源6装满或由于吸取系统2上有裂口、破裂或刺穿而失去真空,以及接合或吸取非流体、固体或半固体物质(例如血栓)。图2A中的吸取监控系统48配置成警告吸取系统2的使用者关于吸取系统2的实时状态(包括操作状态),操作状态包括:是否正在施加真空;流动状态,包括是否与血栓接合,是否正在积极地吸取血栓,系统是否发生漏气,系统是否阻塞,真空源6是否充满和/或需要更换;或其它可能导致的问题。提供的实时反馈使得使用者或操作者无需过多地亲自监控真空源6、延伸管10或吸取系统2的其它部分是否出现不正常或不希望的流动或操作状态,从而允许使用者将更多注意力集中于正在接受治疗的患者身上。
吸取监控系统48的压力换能器12配置成不断测量并监控吸取系统2的封闭系统内的绝对压力幅度,且还配置成随着时间测量并监控相对压力以检测吸取系统2的流动回路内的值得注意的流动变化。一些变化可通过绝对压力测量分辨出来,而更细微的压力偏差可与存储于存储器内的库进行对比。适当时,值得注意的状态可以信号形式发送给使用者。在一些实施方式中,未经滤波的信号可由放大器放大并由滤波器滤波,例如以提高信噪比。图5A至5D中可看到未经滤波信号中的(背景)噪音57的实例(图5A中有标记)。在一些实施方式中,可利用一种或多种算法(如本文所描述)来识别相关的特定状态。
图2B图示了具有压力换能器12的吸取监控系统62的第二实施方式,其中压力换能器12具有设置在外壳40的腔42内的真空传感器50。真空传感器50可由至少一个电池52供电。在一些实施方式中,压力换能器12可重复使用,且可构造成允许通过直接充电方法,或通过本领域已知的感应电力传输方法和装置对电池52或电容器(未示出)充电。与图2A中的吸取监控系统48不同,图2B中的吸取监控系统62包括测量装置64、存储模块66和位于压力换能器12外部的通信装置68。同样位于外部的电源模块72可用于为测量装置64、存储模块66或通信装置68的任何一个供电。通信装置68可以是结合图2A中的吸取监控系统48描述的通信装置58a、58b、58c中的任何一个,并配置成通过警报信号70产生警报。通信装置68可以是便携式的,以便可将其定位成靠近使用者。
在一些实施方式中,通信装置68可由使用者佩戴。图3图示了吸取监控系统78,其包括耦接至测量装置76的天线80。除了测量装置76经由天线80向通信装置74的相应天线82无线发送通信信号84之外,测量装置76与前述实施方式的测量装置54相似。在一些实施方式中,通信装置74包括腕带,腕带由使用者佩戴且可包括振动发生器或热发生器。在一些实施方式中,通信装置74包括可附接至设备或甚至附接至患者或使用者的音频扬声器。在一些实施方式中,通信装置74包括使用者可佩戴的耳机或耳塞上的音频扬声器。在一些实施方式中,可使用通信技术。
图4A图示了处于具有至少一个血栓88的血管86内的吸取导管4的远端16。吸取导管4正沿前向方向F推进,但吸取导管4的远端16尚未到达血栓88的近侧末端94。真空源6(图1)已耦接至吸取导管4的吸取管腔18,并已启动(即阀8打开),使得血液96被吸取入吸取管腔18内(箭头A)。转至图5A,针对图4A中的状态示出了正常流体(例如血液)真空随着时间的相应曲线98。曲线98表示由任何所示实施方式的真空传感器50随着时间感测的真空压力。不存在泄漏且未抽取血栓,因此当真空源6将压力换能器12的腔42内的真空增大(降低压力)至相对稳定的状态时,曲线98包括向下的斜率99。吸取血液96的同时,稳定压力曲线97继续保持。当例如通过关闭阀8或通过使任意两个端口(例如鲁尔接口)分离而使真空与吸取管腔18分开时,或如果真空源6完全充满血液96,则会测量到向上的斜率95。
测量装置54、64配置成将曲线97与存储模块56、66内存储的信息进行比较以识别该状态。在一些实施方式中,测量装置54、64利用算法来进行比较。在一些实施方式中,测量装置54、64然后向通信装置58a-c、74发送信号,且通信装置58a-c、74生成合适的警报。通信装置58a(例如特定颜色的LED)可发光,或LED可以特定模式闪光,或闪光次数是特定的。通信装置58b可形成特征声音,或可生成多种语言形式的音频消息。例如,音频消息可以是“遇到血栓”或“未遇到血栓”。通信装置58c可以特征模式振动或加热,例如以一定次数的重复或一定的重复频率。使用者可确定可能需要附加荧光检查图像(例如血管造影术)或其它成像模式以更好地识别血栓88的位置。
图4B图示了吸取导管4的远端16,其中吸取导管4推进至使得吸取导管4的远端16与血栓88的近侧末端94接触的位置。图5B中的相应曲线93表示所示的任何实施方式的真空传感器50随着时间感测的真空压力。曲线93首先具有向下的斜率99,之后是稳定的压力曲线97,(如在图4A的情况中那样,图5A所图示),然而当吸取导管4的远端16与血栓88的近侧末端94接触时,如果吸取使得血栓88的一部分(例如一大部分或相对较大的部分)进入并陷于吸取管腔18内,则发生阻塞情况。如果真空使得吸取导管4的远端16卡在血栓88上,则会发生类似情况,几乎无任何东西流经吸取管腔18。在任一情况下,曲线93包括流体压力91的偏差(或扰动)。如果阻塞(或卡住情况)持续,则测量到平坦下降的压力89。
测量装置54、64配置成将曲线93与存储模块56、66内存储的信息进行比较以识别该状态。在一些实施方式中,测量装置54、64利用算法来进行比较。在一些实施方式中,预设压力差ΔΡ1可作为阈值存储于存储模块56、66内,由此,测量的小于该阈值的压力差81不会致使测量装置54、64命令通信装置58a-c、74发送警报信号60a-c、70。在一些实施方式中,当压力差81大于(或大于或等于)预设压力差ΔΡ1时,测量装置54、64然后向通信装置58a-c、74发送信号,且通信装置58a-c、74生成合适的警报。通信装置58a(例如特定颜色的LED)可发光,或LED可以特定模式闪光,或闪光次数是特定的。通信装置58b可形成特征性声音,或可生成多种语言形式的音频消息。例如,音频消息可以表达“阻塞状态”。通信装置58c可以特征模式振动或加热,例如以一定次数的重复或一定的重复频率。当使用者意识到存在阻塞情况时,使用者可拉动吸取导管4并重新使其推进,以试图接触可被吸取的血栓88的一部分。如果部分血栓阻塞在吸取管腔18内,且重新定位吸取导管4不会产生好的结果,则可移除吸取导管4,且可例如通过正增压重新清洗吸取系统2。
图4C图示了在吸取系统2已出现裂口的一般情况下的吸取导管4的远端16。例如,破裂、泄漏、刺穿、小孔、松动或断开连接可导致空气被吸入吸取导管4的吸取管腔18、压力换能器12的腔42、延伸管10的内部、阀8或真空源6。如图5C中的曲线85所示,测量到向下的斜率99和随后的稳定压力曲线97,但在裂口87的时间点处,开始测量到向上的斜率83。
测量装置54、64配置成将曲线85与存储模块56、66内存储的信息进行比较以识别该状态。在一些实施方式中,测量装置54、64利用算法来进行比较。在一些实施方式中,测量装置54、64然后向通信装置58a-c、74发送信号,且通信装置58a-c、74生成适当的警报。通信装置58a(例如特定颜色的LED)可发光,或LED可以特定模式闪光,或闪光次数是特定的。通信装置58b可形成特征性声音,或可生成多种语言形式的音频消息。例如,音频消息可以是“系统泄漏”。通信装置58c可以特征模式振动或加热,例如以一定次数的重复或一定的重复频率。接收到警报时,使用者将检查吸取系统2的组件,并修理裂口或更换吸取系统2的一个或多个组件。例如,在某些情况下,通信装置58a-c、74可在测量装置54、64确认失去真空时警告用户,从而使使用者更换或重新充填已耗尽(例如因装满血液和/或血栓)的真空源6。
图4D图示了成功吸取血栓88的块或部分90期间的吸取导管4的远端16。在某些情况下,由于扰动或与吸取管腔18的内壁的碰撞,块或部分90可沿着迂曲路径92被拉动通过吸取管腔18。在某些情况下,例如由于吸取管腔18的内径沿长度不同,块或部分90可附着于吸取管腔18的内壁并在内壁内滑动。在块或部分90行进穿过吸取管腔18的同时,这些情况中的任一种情况可导致压力换能器12感测的压力相应地发生一系列的增大和减小。如图5D的曲线79所示,测量到向下的斜率99和随后的稳定压力曲线97,但当血栓88的块或部分90行进穿过吸取导管4的吸取管腔18时,测量到流体压力发生偏差77,包括多个压力减小和增大(真空压力增大和减小)。当血栓88的块或部分90离开吸取导管4的吸取管腔18的近端时,测量到第二稳定压力曲线75。偏差77的持续时间67是血栓88的特定大量块或部分90的输送量。持续时间67的范围可相当大,但在某些情况下可小于1秒或多达大约30秒。当血栓88的其它块或部分90被吸取入并行进穿过吸取导管4的吸取管腔18时,测量到另一个流体压力偏差73,包括多个压力减小和增大(真空压力增大和减小)。在曲线79末端,真空源6示为完全装满血液96以及血栓88的块或部分90,因此测量到向上的斜率95。
测量装置54、64配置成将曲线79与存储模块56、66中存储的信息进行比较以识别何时正在积极地吸取血栓88的块或部分90(如在偏差77和偏差73中那样),以及何时未积极地或基本未吸取血栓88的块或部分,如在稳定压力曲线75和稳定压力曲线71中那样。在一些实施方式中,测量装置54、64利用算法来进行比较。在一些实施方式中,预设压力差ΔΡ2可作为阈值存储于存储模块56、66内,由此,测量的小于该阈值的压力差69不会致使测量装置54、64命令通信装置58a-c、74通过警报信号60a-c、70发送第一种类型的警报。在一些实施方式中,当压力差69大于(或大于或等于)预设压力差ΔΡ2时,测量装置54、64然后向通信装置58a-c、74发送信号,且通信装置58a-c、74生成合适的警报。通信装置58a(例如特定颜色的LED)可发光,或LED可以特定模式闪光,或闪光次数是特定的。在一些实施方式中,通信装置58a可包括强度随压力成比例增大的光。通信装置58b可形成特征性声音,或可生成多种语言形式的音频消息。例如,音频消息可以是“正在吸取血栓”。在一些实施方式中,通信装置58b可包括一声或多声噪声或哔哔声。在一些实施方式中,通信装置58b可包括与每一种不同情况对应的一连串特定哔哔声。例如,三声短促哔哔声可与无血栓正被吸取对应,而五声长而响亮的哔哔声可与系统泄漏对应。在一些实施方式中,多种不同音调(音高)可用于警示使用者不同的情况。例如,音调低的声音可用于第一种情况(例如,无血栓正被吸取),音调较高的第二种声音可用于第二种情况(例如系统泄漏)。在一些实施方式中,多种不同音调可用于警告使用者第一种情况,而第二多种音调(例如,不同音调的组合,或具有其它音调)可用于警告使用者第二种情况。通信装置58c可以特征模式振动或加热,例如以一定次数的重复或一定的重复频率。当使用者意识到正在吸取血栓时,使用者可例如利用荧光显影选择沿血栓88的长度推进(或收回)吸取导管4,以试图继续吸取血栓88。在某些情况下,使用者可在生成警报之后的一定时间选择停止推进或收回吸取导管4,以使血栓88的块或部分90完全离开吸取管腔18。当测量装置54、64识别到随后的稳定压力曲线75、71(其后跟随偏差77、73)时,在一些实施方式中,测量装置54、64发送使通信装置58a-c、74通过警报信号60a-c、70生成第二种类型的警报的信号。例如,在一些实施方式中,通信装置58b可发送“不再吸取血栓”的音频消息。当使用者意识到不再吸取血栓时,使用者可推进或抽回吸取导管,以试图接触血栓88的另一可吸取部分。在一些实施方式中,偏差77可被肯定地识别为表明正在积极吸取血栓的真实偏差,压力差69在大约700帕至大约1700帕之间。在一些实施方式中,偏差77可被肯定地识别为表明正在积极吸取血栓的真实偏差,压力差69在大约1000帕至大约1300帕之间。在一些实施方式中,偏差77可被肯定地识别为表明正在积极吸取血栓的真实偏差,压力差69为大约1138帕。压力差69可通过确定基线压力63和峰值压力61并确定绝对值差值来测量。例如:
绝对值差值(AVD)=|(-89,631帕)-(-90,769帕)|=1138帕
或例如:
绝对值差值(AVD)=|(-43,710帕)-(-45,102帕)|=1281帕
压力差81(图5B)也可表示可以相似方式识别的偏差,在这之后,通信装置58a-c、74生成合适的警报,例如“阻塞状态”。
由于真空压力为负压力,因此峰值压力61(如图5D所示)的数值实际上小于基线压力63的数值。在一些实施方式中,测量装置54、64也可配置成例如通过利用算法将存储的差值时间tl与偏差77中的多个压力减小和增大中的单独一个的持续时间65进行比较。例如在一些实施方式中,如果持续时间在大约0.001秒至大约0.50秒之间,则偏差77可被肯定地识别为表明正在积极吸取血栓的真实偏差。在一些实施方式中,如果持续时间在大约0.005秒至大约0.10秒之间,则偏差可被肯定地识别为表明正在积极吸取血栓的真实偏差。在一些实施方式中,如果持续时间在大约0.05秒至大约0.20秒之间,则偏差可被肯定地识别为表明正在积极吸取血栓的真实偏差。在一些实施方式中,测量装置54、64配置成在测量到两个或更多压力减小和增大之后辨识出偏差77。在一些实施方式中,测量装置54、64配置成在测量到五个或更多压力减小和增大之后辨识出偏差77。在一些实施方式中,测量装置54、64配置成在测量到十个或更多压力减小和增大之后辨识出偏差77。
将压力换能器12插入图2A的实施方式或图2B的实施方式的管路内不会在测量上改变吸取系统2的性能特征,这是因为腔42相对较短,且内径相对较大,因此不会是流体流动阻力的重要来源。在一些实施方式中,内径可在大约2.2mm(0.086英寸)至大约3.2mm(0.125英寸)之间。在一些实施方式中,由于预先限定的设定点(例如,针对某些阈值)可包括在固件、微控制器内或其它位置,因此测量装置54、64、76无需包括微处理器。在一些实施方式中,包括但不限于图2B中的实施方式,压力换能器12可以是利用其它组件对其进行修改或扩增的现成血压监控系统。在一些实施方式中,现成血压监控系统可用作吸取监控系统48、62、78的输出。在一些实施方式中,吸取导管4的远端16可具有压力换能器。该压力换能器可用作吸取监控系统48、62、78的压力换能器12。在一些实施方式中,压力传感器可位于Tuohy-Borst阀内,且导引器护套、引导导管或系统的另一个组件通过其与吸取管腔18流体连通。在一些实施方式中,压力传感器可位于吸取导管的吸取管腔内的任意位置。
在一些实施方式中,可视警报由包括显示器的通信装置58a提供而非LED,显示器显示特定语言的可视文字消息,例如“遇到血栓”、“未遇到血栓”、“阻塞状态”、“系统泄漏”、“失去真空”、“正吸取血栓”或“不再吸取血栓”。可视消息可与本文描述的任何其它警报信号60a-c、70组合。本文描述的吸取监控系统48、62、78使得正在进行吸取手术(例如经由吸取系统2除去血栓)的使用者知晓实时情况。本领域中的技术人员将认识到,通过获知吸取系统2的实时情况,使用者能够立即对手术做出改变以优化结果,提高患者和/或医务人员的安全性,减少成本(例如所需的真空源6的数量)并减少手术时间(同样是成本效益)。由于使用者在吸取程序期间通常执行多项任务,吸取监控系统48、62、78提供的感觉辅助使得使用者可专注于这些任务,而无需不断试图监控在视觉上很难监控的情况。使用者也可经由输入装置59(图2B)修改和控制吸取监控系统48、62、78,输入装置59可包括数据输入模块、键盘或一系列带有显示的按钮。在一些实施方式中,输入装置59可包括接受语音命令的听觉输入。替代地,使用者可远程输入信息并控制吸取监控系统48、62、78。使用者可在吸取监控系统48、62、78中选择或取消选择的一些警报包括,但不限于:吸取系统2是否可能被堵塞或阻塞,或是否流动正常;是否已接触血栓;已发生阻塞;真空源6是否充足,或是否已耗尽且需要更换;吸取系统2是否存在泄漏;吸取系统2的组件的设置或连接是否正确;是否向远侧推进导管;是否抽回导管;是否继续以相同速度移动导管;是否增大或减小导管的推进速度;是否正在积极地吸取血栓;以及是否已停止积极地吸取血栓。
在一些实施方式中,可使用替代电源,例如具有或不具有AC/DC转换器的标准交流电;直接连接至现有设备(例如真空泵等);太阳能。吸取监控系统48、62、78可以是无菌包装,且可由本领域的技术人员通过已知的技进行重复灭菌。在一些实施方式中,流动或体积计量器可与压力计12结合使用或代替压力计,以确定例如阻塞或真空量的变化。
虽然已详细描述了血栓的吸取,但吸取监控系统48、62、78可用于任何吸取异质介质的吸取应用。这可包括从人体的管道、脉管或体腔,或甚至从人体的固体或半固体部位(包括但不限于脂肪部分、乳房和癌组织)吸取栓塞物(不包括血栓栓塞物)。
在一些实施方式中,吸取系统2作为带有所有或若干所描述的组件的成套工具提供给使用者,然而在其它实施方式中,仅提供吸取监控系统48。虽然本文的讨论包括用于吸取血栓和血液的实施方式,但“流体”一词的定义在本文中应理解为包括液体和气体。
在一些实施方式中,可使用附加或替代传感器来监控流动状态以通知使用者,包括但不限于:多普勒传感器、红外线传感器或激光流动检测装置。在一些实施方式中,可使用外接多普勒传感器。在一些实施方式中,可在延伸管10周围使用红外线传感器或激光流动检测装置。
Claims (20)
1.一种用于实时监控导管吸取的系统,所述系统包括:
外壳,具有适于可拆卸地连接至真空源的第一端口和适于与吸取导管可拆卸地连接的第二端口;
压力传感器,与所述外壳的内部流体连通;
测量装置,耦接至所述压力传感器并构造成测量流体压力的偏差;以及
通信装置,耦接至所述测量装置并配置成当由所述测量装置测量的流体压力的偏差超过预设阈值时生成警报的信号。
2.根据权利要求1所述的系统,其中,所述通信装置配置成响应于由所述测量装置测量的包括真空压力的多个增大和减小的偏差,而生成第一种类型的警报。
3.根据权利要求2所述的系统,其中,真空压力的所述多个增大和减小包括基线真空压力和峰值真空压力,并且其中,所述预设阈值为所述峰值真空压力与所述基线真空压力之间的差值。
4.根据权利要求3所述的系统,其中,所述预设阈值在大约700帕至大约1700帕之间。
5.根据权利要求4所述的系统,其中,所述预设阈值在大约1000帕至大约1300帕之间。
6.根据权利要求5所述的系统,其中,所述预设阈值为大约1158帕。
7.根据权利要求1所述的系统,进一步包括存储模块,其中,所述测量装置配置成将测量的压力的偏差与所述存储模块内包含的信息进行比较。
8.根据权利要求7所述的系统,其中,所述测量装置包括微处理器。
9.根据权利要求1所述的系统,其中,所述第一端口包括凹鲁尔连接器,所述第二端口包括凸鲁尔连接器。
10.根据权利要求1所述的系统,进一步包括:
真空源,用于耦接至所述第一端口;以及
吸取导管,具有用于耦接至所述第二端口的吸取管腔。
11.根据权利要求10所述的系统,其中,所述通信装置配置成响应于由所述测量装置测量的包括真空压力的多个增大和减小的偏差,而生成第一种类型的警报。
12.根据权利要求11所述的系统,其中,真空压力的所述多个增大和减小包括基线真空压力和峰值真空压力,且其中,所述预设阈值为所述峰值真空压力与所述基线真空压力之间的差值。
13.根据权利要求12所述的系统,其中,所述预设阈值在大约700帕至大约1700帕之间。
14.根据权利要求10所述的系统,其中,所述警报的信号由LED、压电装置,或振动装置中的至少一种提供。
15.根据权利要求11所述的系统,其中,第一种类型的所述警报包括可听警报、可视警报和触觉警报中的至少一个。
16.根据权利要求1所述的系统,其中,所述警报的信号由LED、压电装置,或振动装置中的至少一种提供。
17.根据权利要求1所述的系统,其中,所述流体压力包括正从患者吸取的血液的流体压力。
18.根据权利要求2所述的系统,其中,第一种类型的所述警报包括可听警报、可视警报和触觉警报中的至少一个。
19.根据权利要求2所述的系统,其中,真空压力的所述多个增大和减小与正被吸取穿过连接至所述第二端口的吸取导管的吸取管腔的血栓的一个或多个部分对应。
20.根据权利要求2所述的系统,其中,所述通信装置配置成响应于所述测量装置不再测量到包括真空压力的多个增大和减小的偏差而生成第二种类型的警报。
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US20160106890A1 (en) | 2016-04-21 |
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