CN102355862B - 具有集成流体管理的活检设备 - Google Patents

具有集成流体管理的活检设备 Download PDF

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CN102355862B
CN102355862B CN2009801581432A CN200980158143A CN102355862B CN 102355862 B CN102355862 B CN 102355862B CN 2009801581432 A CN2009801581432 A CN 2009801581432A CN 200980158143 A CN200980158143 A CN 200980158143A CN 102355862 B CN102355862 B CN 102355862B
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vacuum
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vacuum passage
biopsy
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CN102355862A (zh
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K·维泽贝克
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CR Bard Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0283Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0266Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B2010/0208Biopsy devices with actuators, e.g. with triggered spring mechanisms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable

Abstract

本发明公开了一种活检设备,其包括由使用者握持的驱动器组件和用于可释放地附接于所述驱动器组件的一次性活检探针组件。驱动器组件包括第一真空通道,所述第一真空通道具有被构造和布置为允许负压流体朝向真空源流动并防止正压流体远离所述真空源流出的第一单向阀。所述一次性活检探针组件包括第二真空通道,所述第二真空通道具有被构造和布置为允许负压流体从样本篮流出并冗余地防止正压流体朝向样本篮流动的第二单向阀。在若干实施例中,流体管理箱被流体地插入在第二真空通道中,以防止残余的活检生物材料从样本篮流到真空源。

Description

具有集成流体管理的活检设备
相关申请的交叉引用
无。
技术领域
本发明涉及一种活检设备,更具体地,涉及一种具有集成流体管理的活检设备。
背景技术
活检可被用在患者身上以帮助确定受检部位的细胞是否癌变。一种用于评估胸部组织的活检技术例如包含将活检探针插入所关注的胸部组织部位以从该部位获取一个或多个组织样本。这种活检技术常常利用真空将待采样的组织拉进活检探针的样本凹口中,之后样本被切断并收集。一种真空辅助型活检设备包括具有真空源的手持驱动器组件,以及被构造为可释放地附接于所述驱动器组件的一次性活检探针组件。但是,在存在由真空源产生的所需负压时,残余的活检生物材料(例如,血液和颗粒物)可随着组织样本从患者身上被吸入真空通道,并且因此可能污染手持驱动器组件。而且,在真空通道中出现不期望的正压的情况下,存在着流体经由一次性活检探针组件沿着从手持驱动器组件到患者体内的方向出现逆流的可能性。
发明内容
本发明提供一种带有流体管理的全集成手持活检设备,以减少活检程序过程中污染物传递的可能性。
在本文中,元件名称之前的术语“第一”和“第二”(例如第一真空通道、第二真空通道等)用于区分具有相似特征的不同元件的识别目的,而不意在必须暗示排序,除非另有说明,且术语“第一”和“第二”也不意在排除包含其他相似的元件。
一种形式的本发明涉及一种活检设备。该活检设备包括被构造为由使用者握持的驱动器组件,以及被构造为可释放地附接于该驱动器组件的一次性活检探针组件。驱动器组件包括机电动力源、真空源以及与真空源永久地相关联的第一真空通道。第一真空通道具有近端和远端,近端以流体连通的方式和真空源固定地联接。第一真空通道具有被构造和布置为允许负压流体朝向真空源流动并防止正压流体远离真空源朝向远端流动的第一单向阀。一次性活检探针组件包括传动装置、活检探针和第二真空通道。传动装置被构造为与所述机电动力源驱动接合。活检探针可驱动地联接到传动装置,活检探针具有用于接收活检组织样本的样本篮。第二真空通道具有第一端和第二端,第一端被构造为可移除地附接于第一真空通道的远端,并且第二端以流体连通的方式与样本篮联接。第二真空通道具有被构造和布置为允许负压流体从样本篮流出并冗余地防止正压流体从第二真空通道的第一端朝向样本篮流动的第二单向阀。
在若干实施例中,例如,一次性探针组件还可包括在第一端和第二端之间的流体地(fluidically)插入第二真空通道中的流体管理箱。流体管理箱包括箱体和包含在箱体内的过滤器装置。过滤器装置被构造为防止残余的活检生物材料从样本篮流到真空源。
另一种形式的本发明涉及一种用于活检设备中的流体管理系统,该活检设备使用具有被构造为接收活检组织样本的样本篮的活检探针。流体管理系统包括真空源、非一次性真空通道以及一次性真空通道。非一次性真空通道具有近端和远端,近端以流体连通的方式和真空源流体固定地联接。非一次性真空通道包括被构造和布置为允许负压流体朝向真空源流动并防止正压流体远离真空源朝向非一次性真空通道的远端流动的第一单向阀。一次性真空通道经由非一次性真空通道临时地和真空源流体连通。一次性真空通道具有第一端和第二端,第一端被构造为可移除地附接于非一次性真空通道的远端,且第二端以流体连通的方式与样本篮联接。一次性真空通道具有被构造和布置为允许负压流体从样本篮朝向真空源流动并冗余地防止正压流体远离非一次性真空通道的远端朝向样本篮流动的第二单向阀。
另一种形式的本发明涉及被构造为可释放地附接于驱动器组件的一次性活检探针组件,驱动器组件包括机电动力源、真空源以及与真空源永久地相关联的第一真空通道。一次性活检探针组件包括传动装置、活检探针、第二真空通道和流体管理箱。传动装置被构造为用于和所述机电动力源驱动接合。活检探针可驱动地联接到传动装置。活检探针具有用于接收活检组织样本的样本篮。第二真空通道具有第一端和第二端,第一端被构造为可移除地附接于第一真空通道,且第二端以流体连通的方式与样本篮联接。第二真空通道具有被构造和布置为允许负压流体从样本篮流出并防止正压流体从第二真空通道的第一端朝向样本篮流动的单向阀。流体管理箱被流体地插入第二真空通道中在第一端和第二端之间。流体管理箱包括箱体和包含在箱体内的过滤器装置,过滤器装置被构造为防止残余的活检生物材料随着负压流体流从样本篮流到真空源。过滤器装置包括多个并列布置的流体吸收层,每个流体吸收层与相邻的流体吸收层间隔开,且每个流体吸收层具有各自的贯穿开口,其中多个流体吸收层的相邻贯穿开口偏置,以形成穿过多个流体吸收层的曲折开放流体通路。
根据本发明的一个或多个方面,当将一次性探针组件安装在驱动器组件上时,驱动器组件和一次性活检探针组件之间的流体连接界面是自动的。因此,无需操作者的特定动作来建立一次性活检探针组件的真空通道和驱动器组件的真空源之间的连接。
而且,根据本发明的一个或者多个方面,活检设备设置有防止非侵入性可重复使用的驱动器组件和一次性活检探针组件之间交叉污染的多层防护。另外,还设置有防止从真空源到患者的逆流(正压流)的多层防护。而且,通过在一次性活检探针组件上设置流体管理箱便于防止交叉污染,从而提供活检流体的全封闭储存以减少在后续流程中溢出的风险、并提供来自真空通道的活检液体的多级吸收,以及这样做同时允许活检设备的360度旋转而不会损坏真空通道。
附图说明
通过结合附图参考下文中本发明一个实施例的描述,本发明的上述及其他特征和优点、以及获得所述特征和优点的方式将变得更加清楚,且本发明也更易于理解,其中:
图1是根据本发明一个实施例进行构造的活检设备的立体图,其中,一次性活检探针安装在驱动器组件上;
图2是图1的活检设备的立体图,一次性活检探针从驱动器组件上分离;
图3是图1的活检设备的示意图;
图4A是图3的驱动器组件的真空通道的真空密封件的立体图;
图4B是图3的一次性活检探针的真空通道的真空密封件的立体图;
图5A是图2和3所示的一次性活检探针的流体管理箱的立体图,所述流体管理箱部分被破开以露出过滤器装置;
图5B是图5A的过滤器装置的多个流体吸收层的分解图;
图5C是图5A的过滤器装置的多孔过滤器元件的立体图。
在所有附图中,附图标记与所指示的部分对应。本文中所展示的范例是本发明的一个实施例,该范例不被理解为以任何方式限制本发明的范围。
具体实施方式
参见附图、特别是参见图1和图2,示出活检设备10,其通常包括:例如非一次性的非侵入性驱动器组件12和一次性活检探针组件14。
还参考图3,驱动器组件12和一次性活检探针组件14共同包括流体管理系统16,所述流体管理系统16包括真空源18、第一真空通道20和第二真空通道22。真空源18和第一真空通道20永久地与驱动器组件12相关联,第二真空通道22永久地与一次性活检探针组件14相关联,以有助于实现安全高效地采集活检组织样本,如在下文中全面描述的那样。
在本文中,术语“非一次性”是指计划在装置的使用寿命内用于多个患者的装置,术语“一次性”是指计划用于一个患者后就被弃置的装置。而且,“真空通道”指用于在两点之间实现真空的流体通路,所述流体通路穿过一个或多个部件,比如举例而言,一个或多个管状物、管道、联接器和插入装置。而且,“永久地相关联”是指计划在部件的使用寿命内用于不可释放地附接于常规基础的连接。所以,例如,包括真空源18和第一真空通道20的驱动器组件12整体作为一个单元可以重复使用,而一次性活检探针组件14和第二真空通道22整体作为一个单元可被弃置。
驱动器组件12包括壳体24,所述壳体24被构造成并且被人体工学地设计成由使用者握持。驱动器组件12包括(包含在壳体24内)真空源18、第一真空通道20、控制器26、机电动力源28和真空监视机构30。用户界面32被定位于安装在壳体24上,并且相对于壳体24可从外部接近。
控制器26流通地联接到机电动力源28、真空源18、用户界面32和真空监视机构30。控制器26可包括例如微处理器和用于执行程序指令的关联存储器,以执行与取回活检组织样本相关联的功能,诸如控制一个或者多个真空源18和机电动力源28的部件。控制器26还可以执行程序指令以监视活检设备的部件的一个或者多个条件和/或位置,以及监视与驱动器组件12和一次性探针组件14相关联的流体管理系统16的状态。
用户界面32包括控制按钮321和可视指示器322,控制按钮321使用户控制活检设备10的各种功能,可视指示器322提供活检设备10的部件的一个或者多个条件和/或位置的状态的视觉反馈。
机电动力源28可包括例如电源(比如电池34)和电驱动组件36。电池34可以例如是充电电池。电池34给活检装置10中的所有电动部件提供电力,在图中为简化起见,这些电联接没有示出。例如,电池34和真空源18、控制器26、用户界面32以及电驱动组件36电联接
在本实施例中,电驱动组件36包括第一驱动361和第二驱动362,每一个分别联接到电池34,并且第一驱动361和第二驱动362中的每一个都分别可控制地电联接到用户界面32。
第一驱动361可包括电机381和运动传递单元401(图中用一根线示意性示出)。第二驱动362可包括电机382和运动传递单元402(图中用一根线示意性示出)。每个电机381,382例如是直流(DC)电机、步进电机等等。第一驱动361的运动传递单元401例如被构造为带有旋转运动到线性运行转换器,比如蜗轮装置、齿条齿轮传动装置、螺线管滑动装置等。第二驱动362的运动传递单元402被构造为传递旋转运动。第一驱动362和第二驱动362中的每一个可包括一个或者多个齿轮、齿轮系、皮带/带轮装置等。
真空源18电联接到电池34,并具有用于建立真空的真空源端口181。真空源18可控制地电联接到用户界面32。真空源18例如还包括由电机183驱动的真空泵182。真空泵182例如可以是蠕动泵、隔膜泵、注射器型泵等。
驱动器组件12的第一真空通道20永久地与真空源18相关联。第一真空通道20(有时也称为非一次性真空通道)具有近端201和远端202,并且包括例如管道203、第一单向阀204和颗粒过滤器205。近端201以流体连通的方式被固定地联接到真空源18,例如,固定地连接到真空源18的真空源端口181。还参考图4A,远端202包括第一真空密封件206。在本实施例中,第一真空密封件206是围绕第一真空通道20的第一通路207的平面邻接表面。
第一单向阀204被构造和布置为允许负压流体朝向真空源18流动并且防止正压流体朝向第一真空通道20的远端202远离真空源18流动。第一单向阀204例如可以是止回阀(诸如球阀和簧片阀),所述止回阀随着流体朝向真空源18流动而打开,并且在远离真空源18逆(正压)流的情况下关闭。
在本实施例中,颗粒过滤器205位于真空源18和第一真空通道20的远端202之间。颗粒过滤器205例如可以是由金属或塑料形成的网筛。但是,可以预期的是,颗粒过滤器205可以位于真空源18和活检探针组件14的真空接收部件之间的流体管理系统16中。
真空监视机构30联接到真空源18,以在所感测到的真空水平低于阈值水平时关闭真空源18。真空监视机构30例如可以包括:在控制器26上执行的真空监视控制程序,以及联接到控制器26、并且和第一真空通道20流体连通以探测第一真空通道20中的压力的压力传感器301。如果例如第一真空通道20中的真空流水平低于预定的水平,指示流体管理系统16中存在限制,则控制器26可以响应关闭真空源18,例如,关闭电机183。或者,控制器26可以监视供给电机183的电流,如果电流超过预定的值,指示流体管理系统16内存在限制,则控制器26可以响应关闭真空源18,例如关闭电机183。
一次性活检探针组件14被构造为可释放地附接于驱动器组件12。在本文中,“可释放地附接”是指便于实现所计划的临时连接、并且之后涉及无需工具相对于驱动器组件12操作一次性活检探针组件14的选择性分离的构造。
一次性活检探针组件14包括安装有传动装置42、活检探针44和第二真空通道22的框架141。活检探针44可驱动地联接到传动装置42,并且传动装置42可驱动地联接到驱动器组件12的机电动力源28。
在所示的实施例中,传动装置42包括可驱动地与活检探针44的各种部件接合的第一受驱动单元421和第二受驱动单元422。而且,第一受驱动单元421与驱动器组件12的电驱动组件36的第一驱动361可驱动地接合。第二受驱动单元422与驱动器组件12的电驱动组件36的第二驱动362可驱动地接合。
在所示实施例(例如参见图1-3)中,活检探针44包括样本篮441和切割器套管442。样本篮441具有帮助刺入组织的锋利尖端443,并且具有采用凹进区域的形式、用于接收活检组织样本的样本凹口444。
在操作中,切割器套管442由第一受驱动单元421线性地驱动以在样本篮441的样本凹口444之上来回移动。例如,第一受驱动单元421可以线性滑动的形式可驱动地与驱动器组件12的第一驱动361接合,所述第一驱动361沿第一方向46驱动切割器套管442以露出样本篮441的样本凹口444,并且沿与第一方向46相反的第二方向48驱动切割器套管442以切断垂落在样本凹口444中的组织。而且,第一受驱动单元421和第二受驱动单元422被构造为共同运行,以在刺穿射击手术(piercing shot operation)中共同推进样本篮441和切割器套管442,从而有助于将活检探针44插入纤维组织内。
第二受驱动单元422可以包括柔性的带齿齿条50和齿轮系52。柔性的带齿齿条50连接到样本篮441,并且齿轮系52与柔性的带齿齿条50上的齿接合。在操作中,第二驱动362将旋转运动传递给齿轮系52,接着齿轮系52与柔性的带齿齿条50接合以线性地移动样本篮441,从而将样本凹口444中获取的组织从患者体内传出。在缩回时,柔性的带齿齿条50收纳在卷绕单元54内,因此与刚性获取系统相比明显减少了活检设备10的整体装置长度。切断的组织样本从患者体内传出,然后送入组织样本室56(安装在框架141上)内,所述样本室56将组织样本从样本凹口444挖出。
在本实施例中,第二真空通道22(有时也称为一次性真空通道22)具有第一端221和第二端222,并且包括例如管道223、第二单向阀224以及流体管理箱225。第一端221被构造为可移除地附接于驱动器组件12的第一真空通道20的远端202。第二端222以流体连通的方式和样本篮441联接,并且更具体地,以流体连通的方式和样本篮441的样本凹口444联接。
还参见图4B,一次性真空通道22的第一端221包括第二真空密封件226。当一次性活检探针组件14附接在驱动器组件12上时,驱动器组件12的第一真空密封件206以密封接合的方式接触一次性活检探针组件14的第二真空密封件226。第二真空密封件226是围绕第二真空通道22的第二通路227的柔顺(例如橡胶)环状构件。
第二单向阀224被构造和布置为允许负压流体从样本篮441朝向第二真空通道22的第一端221流动,并冗余地(与驱动器组件12的第一单向阀204配合)防止任何正压流体沿着从第二真空通道22的第一端221朝向样本篮441的方向流动。换句话说,第二单向阀224提供一种冗余的第二层级保护以防止任何正压到达样本篮441的样本凹口444。在本实施例中,第二单向阀224可以例如是鸭嘴阀,比如簧片阀,所述鸭嘴阀随着流体流出鸭嘴阀的嘴部而打开,随着逆流而关闭。如所示那样,第二单向阀224可以定位在第二真空通道222的第一端221处的第二真空密封件226内。
还参见图5A,流体管理箱225在第一端221和第二端222之间被流体地插入第二真空通道22中。流体管理箱225包括箱体58和包含在箱体58内的过滤器装置60,所述过滤器装置被构造为防止残余的活检生物材料(例如,血液和颗粒物)从样本篮441的样本凹口444流到驱动器组件12的真空源18。
流体管理箱225的箱体58有第一端口581和第二端口582,第二真空通道22在第一端口581和第二端口582之间延续。流体管理箱225的第二端口582联接到样本篮441。第二真空通道22的第二单向阀224和第二真空密封件226中的每一个联接到流体管理箱225的第一端口581,并且在本实施例中安装到流体管理箱225的箱体58的外表面上。
如图5A和5B所示,过滤器装置60包括多个并列布置的流体吸收层62,被单独标示为621、622、623和624,每个流体吸收层621、622、623和624与相邻的流体吸收层(比如621对622,622对623,623对624)间隔开。每个流体吸收层621、622、623和624具有各自的贯穿开口641、642、643、644,其中多个流体吸收层62的贯穿开口641、642、643、644中的相邻开口例如沿至少X,Y和Z方向中的一个方向彼此偏置,以形成穿过多个流体吸收层62的曲折开放的流体通道66。每个流体吸收层621、622、623和624例如可以是吸水纸。
如图5A和5C所示,过滤器装置60还可包括沿着定义第二通路227的第二真空通道22布置为与多个流体吸收层62流体串联的多孔过滤件68。当多孔过滤件68中增加数量的小孔70被残余的活检生物材料(比如血液和组织颗粒)堵塞时,多孔过滤件68会增加对流体流动的限制。当流过流体管理箱225的流体体积减少到预定水平时,真空监视机构30感测到真空限制,控制器26响应以关闭真空源18。
虽然本发明已用至少一个实施例进行描述,但是本发明还可以在本公开的范围和精神内进行改动。因此,本申请意在覆盖使用其一般原则的任何变型、使用和改进。另外,本申请意在覆盖属于本发明且落入所附权利要求限制之内的来自业内公知或惯常实践的本公开的偏差方案。

Claims (19)

1.一种活检设备,所述活检设备包括:
(a)被构造为由使用者握持的驱动器组件,所述驱动器组件包括:
机电动力源;
真空源;以及
与所述真空源永久地相关联的第一真空通道,所述第一真空通道具有近端和远端,所述近端以流体连通的方式与所述真空源固定地联接,所述第一真空通道具有被构造和布置为允许负压流体朝向所述真空源流动并防止正压流体远离所述真空源朝向所述远端流动的第一单向阀;以及
(b)被构造为可释放地附接于所述驱动器组件的一次性活检探针组件,所述一次性活检探针组件包括:
被构造为与所述机电动力源驱动接合的传动装置;
与所述传动装置可驱动地联接的活检探针,所述活检探针具有用于接收活检组织样本的样本篮;以及
具有第一端和第二端的第二真空通道,所述第一端被构造为可移除地附接于所述第一真空通道的所述远端,并且所述第二端以流体连通的方式与所述样本篮联接,所述第二真空通道具有被构造和布置为允许负压流体从所述样本篮流出并冗余地防止正压流体从所述第二真空通道的所述第一端朝向所述样本篮流动的第二单向阀;
其中,所述一次性活检探针组件包括在所述第一端和所述第二端之间的被流体地插入所述第二真空通道中的流体管理箱,所述流体管理箱包括箱体和包含在所述箱体内的过滤器装置,所述过滤器装置被构造为防止残余的活检生物材料从所述样本篮流到所述真空源。
2.根据权利要求1所述的活检设备,其中:
所述第一真空通道的所述远端包括第一真空密封件;以及
所述第二真空通道的所述第一端包括第二真空密封件,当所述一次性活检探针组件附接到所述驱动器组件上时,所述第一真空密封件以密封接合的方式接触所述第二真空密封件,所述第二单向阀被定位在所述第二真空密封件内。
3.根据权利要求2所述的活检设备,其中所述第一真空密封件是围绕所述第一真空通道的第一通路的平面邻接表面,并且所述第二真空密封件是围绕所述第二真空通道的第二通路的柔顺环状构件。
4.根据权利要求1的活检设备,所述活检设备还包括:
位于所述第一真空通道的所述远端处的第一真空密封件;
位于所述第二真空通道的第一端处的第二真空密封件,当所述一次性活检探针组件附接于所述驱动器组件时,所述第一真空密封件以密封接合的方式接触所述第二真空密封件;以及
所述流体管理箱的所述箱体具有第一端口和第二端口,所述第二真空通道在所述第一端口和所述第二端口之间延续,所述第二端口联接到所述样本篮;以及
所述第二单向阀和所述第二真空密封件中的每一个联接到所述第一端口,并且安装到所述流体管理箱的所述箱体的外表面上。
5.根据权利要求1的活检设备,其中所述过滤器装置包括多个并列布置的流体吸收层,每个流体吸收层与相邻的流体吸收层间隔开,每个流体吸收层具有各自的贯穿开口,其中所述多个流体吸收层的相邻贯穿开口偏置,以形成穿过所述多个流体吸收层的曲折开放流体通路。
6.根据权利要求5的活检设备,其中所述过滤器装置还包括沿着所述第二真空通道被布置为与所述多个流体吸收层流体串联的多孔过滤件,其中当所述多孔过滤件中增加数量的小孔被残余的活检生物材料所堵塞时,所述多孔过滤件增加对流体流动的限制。
7.根据权利要求6的活检设备,所述活检设备还包括联接到所述真空源的真空监视机构,在流过所述流体管理箱的所述流体的体积已减少到预定水平时所述真空监视机构切断所述真空源。
8.根据权利要求7的活检设备,其中所述真空监视机构包括和所述第一真空通道流体连通的压力传感器。
9.根据权利要求1的活检设备,所述活检设备还包括位于所述真空源和所述第一真空通道的所述远端之间的颗粒过滤器。
10.一种用在活检设备中的流体管理系统,所述活检设备使用具有被构造为接收活检组织样本的样本篮的活检探针,所述流体管理系统包括:
真空源:
具有近端和远端的非一次性真空通道,所述近端以流体连通的方式和所述真空源固定地联接,所述非一次性真空通道包括被构造和布置为允许负压流体朝向所述真空源流动并防止正压流体远离所述真空源朝向所述非一次性真空通道的所述远端流动的第一单向阀;
经由所述非一次性真空通道以流体连通的方式和所述真空源临时联接的一次性真空通道,所述一次性真空通道具有第一端和第二端,所述第一端被构造为可移除地附接于所述非一次性真空通道的所述远端,并且所述第二端以流体连通的方式与所述样本篮联接,
所述一次性真空通道包括被构造和布置为允许所述负压流体从所述样本篮朝向所述真空源流动并冗余地防止所述正压流体远离所述非一次性真空通道的所述远端朝向所述样本篮流动的第二单向阀,
其中,所述流体管理系统包括在所述第一端和所述第二端之间的被流体地插入所述一次性真空通道中的流体管理箱,所述流体管理箱包括箱体和包含在箱体内的过滤器装置,所述过滤器装置被构造为防止残余的活检生物材料从所述样本篮到所述真空源的流动。
11.根据权利要求10的流体管理系统,其中:
所述非一次性真空通道的所述远端包括第一真空密封件;以及
所述一次性真空通道的所述第一端包括第二真空密封件,所述第一真空密封件以密封接合的方式和所述第二真空密封件接触,所述第二单向阀被定位成和所述第二真空密封件相邻。
12.根据权利要求10的流体管理系统,所述流体管理系统还包括:
位于非一次性真空通道处的第一真空密封件;
位于所述一次性真空通道的所述第一端处以接触所述第一真空密封件的第二真空密封件;以及
所述流体管理箱的所述箱体具有第一端口和第二端口,所述一次性真空通道在所述第一端口和所述第二端口之间延续,所述第二端口联接到所述样本篮;以及
所述第二单向阀和所述第二真空密封件中的每一个联接到所述第一端口,并且安装到所述流体管理箱的所述箱体的外表面上。
13.根据权利要求10的流体管理系统,其中所述过滤器装置包括多个并列布置的流体吸收层,每个流体吸收层与相邻的流体吸收层间隔开,每个流体吸收层具有各自的贯穿开口,其中所述多个流体吸收层的相邻贯穿开口偏置,以形成穿过所述多个流体吸收层的曲折开放流体通路。
14.根据权利要求13的流体管理系统,其中所述过滤器装置还包括沿着所述一次性真空通道被布置为与所述多个流体吸收层流体串联的多孔过滤件,其中当所述多孔过滤件中增加数量的小孔被残余的活检生物材料所堵塞时,所述多孔过滤件增加对流体流动的限制。
15.根据权利要求14的流体管理系统,所述流体管理系统还包括联接到所述真空源的真空监视机构,在流过所述流体管理箱的所述流体的体积已减少到预定水平时所述真空监视机构切断所述真空源。
16.权利要求10的流体管理系统,所述驱动器组件包括在所述真空源和所述第一真空通道的所述远端之间的被插入所述第一真空通道中的颗粒过滤器。
17.一种一次性活检探针组件,所述一次性活检探针组件被构造为可释放地附接于驱动器组件,所述驱动器组件包括机电动力源、真空源以及与所述真空源永久地相关联的第一真空通道,所述一次性活检探针组件包括:
被构造为与所述机电动力源驱动接合的传动装置;
与所述传动装置可驱动地联接的活检探针,所述活检探针具有用于接收活检组织样本的样本篮;以及
具有第一端和第二端的第二真空通道,所述第一端被构造为可移除地附接于所述第一真空通道,并且所述第二端以流体连通的方式与所述样本篮联接,所述第二真空通道具有被构造和布置为允许负压流体从所述样本篮流出并防止正压流体从所述第二真空通道的所述第一端朝向所述样本篮流动的单向阀;
在所述第一端和所述第二端之间的流体地插入所述第二真空通道的流体管理箱,所述流体管理箱包括箱体和包含在所述箱体内的过滤器装置,所述过滤器装置被构造为防止残余的活检生物材料随着负压流体流从所述样本篮流到所述真空源,
所述过滤器装置包括多个并列布置的流体吸收层,每个流体吸收层与相邻的流体吸收层间隔开,每个流体吸收层具有各自的贯穿开口,其中所述多个流体吸收层的相邻贯穿开口偏置,以形成穿过所述多个流体吸收层的曲折开放流体通路。
18.根据权利要求17的一次性活检探针组件,其中所述过滤器装置还包括沿着所述第二真空通道被布置为与所述多个流体吸收层流体串联的多孔过滤件,其中当所述多孔过滤件中增加数量的小孔被残余的活检生物材料所堵塞时,所述多孔过滤件增加对流体流动的限制。
19.根据权利要求17的一次性活检探针组件,其中所述箱体具有第一端口和第二端口,所述第二真空通道在所述第一端口和所述第二端口之间延续,所述第二端口联接到所述样本篮,并且所述单向阀和第二真空密封件中的每一个联接到所述第一端口,并且安装到所述流体管理箱的所述箱体的外表面上。
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