CN113650956B - 集成流体模块和测试装置 - Google Patents

集成流体模块和测试装置 Download PDF

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Publication number
CN113650956B
CN113650956B CN202110818065.7A CN202110818065A CN113650956B CN 113650956 B CN113650956 B CN 113650956B CN 202110818065 A CN202110818065 A CN 202110818065A CN 113650956 B CN113650956 B CN 113650956B
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test
fluid
reservoir
delivery
outlets
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CN113650956A (zh
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约翰·凯利
休·沃利斯
基思·博基基奥
晟严孔
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Atomo Diagnostics Ltd
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Atomo Diagnostics Ltd
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Abstract

公开了一种集成测试装置和流体模块，以及制造方法。流体模块包括容纳测试流体的贮存器和控制容器。贮存器将测试流体排放到控制容器，所述控制容器以受控方式将测试流体排放到测试部件。

Description

集成流体模块和测试装置
本申请是申请号为201680092001.0、进入国家阶段日为2019年7月11日、发明名称为“集成流体模块和测试装置”的原申请的分案申请。
技术领域
本发明涉及用于提供需要测试流体的测试的装置和方法，以及促进这种测试的装置和盒。
背景技术
进行能够在测试时获得相对快速的结果的各种测试，例如医学测试、化验和工业测试。这些可以是例如家庭测试、护理点测试、或用于实验室、病理诊所或医院。
执行这些相对快速的测试可能需要复杂的指令和要使用的多个装置和部件。本发明不涉及要进行的特定化学或生物化学测试，而是涉及容纳和包含测试部件的装置、流体输送和相关的机械系统。例如，在医学背景下，这种装置和系统可以与横向流动或其它类型的快速测试一起使用。
例如，在典型的传统家庭或护理点血液测试中，向用户呈现部件的集合，包括测试装置本身、单独的柳叶刀、血液收集容器、缓冲液或其它测试流体的容器、胶粘绷带、清洁擦拭物、以及可能的其它部件。期望用户遵循非常精确的步骤顺序，通常包括清洁部位、操作柳叶刀、获得已知体积的血液样本并将其输送到所需的精确位置、在适当的时间和地点并以正确的体积和速率应用缓冲溶液、读取测试结果并解释结果。
许多测试以不频繁或一次性的程序执行，使得用户不会通过常规使用变得熟练。在护理点执行的程序通常由熟练的操作员执行，但是执行测试所需的复杂性和灵活性提出了挑战，并且可能不经常执行特定测试。在这种情况下，如果测试装置可以更好地促进简单、可靠和准确的操作将是有利的。
在此引入作为参考的公开内容的PCT申请PCT/AU2011/000315和PCT/AU2011/022321中，本申请人公开了集成测试装置。特别地，那些装置可包括生理上可接受的流体(例如缓冲液)的贮存器或小袋。对于许多测试，例如某些血液测试，为了获得有效的结果或在可接受的时间范围内达到结果，需要在血液样本后将缓冲液或其它试剂应用于测试材料。在这些公开的实施方式中公开的装置允许用户将流体(例如缓冲液)从内部贮存器排放到测试材料上。
通过引用结合于此的PCT公开No.WO2015075677公开了测试装置和方法，其中测试装置内的贮存器向控制容器中排放，使得流体输送到测试材料的速率受到控制。
本发明的目的是提供一种改善流体向测试材料的输送的测试装置、流体输送模块和方法。
发明内容
在广义形式中，本发明提供了一种用于输送测试流体的集成盒(package)，以及一种用于形成这种盒的方法。
根据一个方面，本发明提供了一种用于形成液体填充的贮存器的方法，所述贮存器具有易碎密封，易碎密封横跨从液体填充的贮存器延伸的流体管道，所述方法包括以下步骤：形成贮存器本体；用液体填充贮存器本体；将基部部件定位在贮存器本体上并使用一组第一工具将基部部件热密封到贮存器本体，以在贮存器本体周围除管道之外形成流体紧密密封；以及使用一组第二工具横跨管道进行热密封，其中由第二工具施加的热横跨管道形成易碎密封。
本发明还包括通过上述方法形成的流体填充的模块。
根据另一方面，本发明提供一种集成测试装置，包括：测试部件；测试流体模块，其包括容纳测试流体的贮存器、输送容器和连接贮存器和输送容器的管道；以及流体输送致动器，其中所述流体输送致动器的操作引起测试流体从贮存器排放到输送容器中，所述输送容器适于提供将测试流体受控排放到测试部件上。
根据另一方面，本发明提供了一种输送用于进行集成测试的测试流体的方法，至少包括以下步骤：提供测试单元，所述测试单元包括测试部件、流体模块以及流体输送致动器，所述流体模块具有容纳测试流体的贮存器、输送容器、以及连接贮存器和输送容器的管道；操作流体输送致动器，从而在贮存器上施加压力；由于贮存器上的压力，将液体排放到输送容器中；从而提供从输送容器到测试部件的受控流体排放。
本发明的实施方式还可以简单地通过改变容器中的开口的尺寸和/或形状来允许不同的排放速率。流体可以直接从控制容器排放到测试部件上，或者通过管道或通道排放。
在整个说明书和权利要求书中，术语“受控排放”是指以比单纯地以单个爆发来排放小袋的全部内容更加受控流速的方式从容器中排放流体。在一种形式中，它可能仅仅相当于减慢流速。其它形式中，它可以更严密地控制排放速率并使其与测试要求紧密相匹配。在许多形式中，排放率不会是恒定的。
因此，本发明的实施方式允许方便、准确和实用的流体输送模块，用于集成测试和其它应用。
附图说明
现在将参考附图描述本发明的说明性实施方式，其中：
图1示出了本发明的实施方式的等距视图，其中柳叶刀没有被激活；
图2是处于第一位置的实施方式的剖视图；
图3是处于第二位置的实施方式的剖视图；
图4是处于第三位置的实施方式的剖视图；
图5是根据一种实施方式的血液采集臂的等距视图；
图6是图1的实施方式的平面图，其中上部被移除；
图7A，7B和7C是说明装置的实施方式中的流体运动的详细部分；
图8示出了处于填充状态的盒的实施方式；
图9示出了处于排空状态的盒的实施方式；
图10是说明一种实施方式中的井(well)和测试条之间关系的详细视图；
图11示出了盒的实施方式的部件；
图12示出了生产盒的实施方式的第一阶段；
图13示出了图12中未密封的结果；
图14说明了生产盒的实施方式的第二阶段；
图15示出了用于在密封的第一阶段中热密封图12的实施方式的概念工具；
图16示出了用于在生产的第二阶段中热密封图14的实施方式的概念工具；和
图17A，17B，17C示出了根据本发明的一个实施方式的互锁机构；和
图18A，18B和18C是说明易碎密封的形成的剖视图。
具体实施方式
将参考许多可能的实施例描述本发明。应当理解，除了提供的示例之外，本发明还能够以多种方式实现。实施例旨在作为说明性的，并且决不限制本发明构思或其可能的实现方式。此外，应当理解，不同实施例的特征可以形成为不同的组合，或者加在一起，以提供本发明的进一步实施方式。
本发明主要涉及测试装置的操作的具体方面，涉及用于接触测试材料的流体的排放，以及用于排放测试流体的模块的制造和构造。因此，虽然将提供和描述测试单元的其余机械结构的具体示例，但是应该理解，原则上本发明可以与这种测试单元的任何设计一起使用。特别地，可以修改已知的测试单元以及通过引用并入的说明书中公开的测试单元，以结合本发明的实施方式。
虽然将主要参考医学应用来描述本发明，但是应当理解，本发明可以应用于许多其它形式的工业或实验室测试，在这些测试中，必须在确定结果之前将测试流体添加到测试材料或测试样本中。其它可能的应用实例包括环境测试、生物安全、食品安全、非法药物测试和兽医学。
图1和2图示了本发明的一种实施方式，图2为剖面图。测试单元10包括盖15，盖15包括用于排放测试流体41的可压下部26。测试流体41容纳在盒40中。测试单元10还包括臂25，臂25具有用于体液的收集装置28，体液在本例中为血液。测试单元10还具有用于待被接收的血液样本的开口20，以及指示器开口21，通过该指示器开口21可以看到测试结果。
盒40包括容纳测试流体41的流体贮存器43、易碎密封55和井50。
如下面将更详细描述的，在使用中，操作者根据该实施方式操作柳叶刀30以从身体上的合适部位(例如手指)排放血液。在该实施方式中，柳叶刀30与单元集成在一起，但是在其它实施方式中，柳叶刀30可以是单独提供的装置。柳叶刀30是弹簧加载的并且一旦被致动将刺入用户的手指。用户可能需要从刺血部位挤出血液以提供足够的样本。
在图2中，一旦移除盖31，柳叶刀30就可以使用了。在图3中，柳叶刀30已经被操作，然后在身体10内被抽出(为了安全起见)。该装置现已准备好收集血液。将收集装置28置于渗出的血液上，并(在这种情况下通过毛细管作用)取出样本。其它样本收集布置可以在替代实施方式中使用，例如非整体抽吸或毛细管装置，或者将流体直接放置在测试材料60上。在所示的布置中，收集装置28将仅保留所需体积的血液。
在填充收集装置之后，然后可以将臂25旋转(如下面将更详细描述的)到输送位置。然后，收集装置通过开口20与测试材料60接触，并将样本排放到测试材料60上。这在图4中示出。
然后，用户可以对部26按压，向盒40施加力，使得流体贮存器43中的压力充分增加，使得易碎密封55失效从而允许测试流体41被排放并流入井50中。井50具有一个或多个开口(在这些视图中未示出)，其允许测试流体41以受控的速率排放到测试材料60上。
需要强调的是，本发明可以应用于任何类型的测试，控制测试流体引入测试材料的速率。在本例中，该测试说明性地是横向流动测试。然而，可以使用任何其它所需类型的免疫测定、色谱测定、DNA测定、酶测定或其它测试。测试可以是或使用电子、光学或其它传感器，以及或代替横向流动或类似测试。测试可以由操作员读取，或者用电子或其它自动化系统解释。类似地，测试流体可以是水、缓冲溶液或任何其它所需的流体，以进行、支持或以其它方式与测试结合使用。
在其它实施方式中，流体可在引入测试材料之前与待测试样本混合。同样应理解，虽然所示的实施方式示出了单个盒的使用。在其它实施方式中，可以存在多个盒，例如以在单个单元中执行多个测试。在其它实施方式中，盒可以例如使用单独的排放开口从井排放到多于一个测试材料上。
图6A和6示出了小袋40的一种实施方式，在这种情况下，该小袋40是以与吸塑盒(blister pack)类似的方式形成的结构。流体容纳在吸塑部42中。出口管43由密封44封闭，其相对于装置的其余部分具有降低的强度，例如通过具有较薄的壁。这种小袋可以使用传统的吸塑盒技术制造。
图5更详细地示出了臂25和相关的结构。在所示的实施方式中，臂25作为互锁装置操作，以防止测试流体41输送到测试材料60上，直到臂25旋转到输送位置。
在图5中，可以看到凸轮32，32A。凸轮32，32A的旋转位置通过与可压下部26的对应部分的接合来判定贮存器中的流体是否可以被排放。
在图17A中，柳叶刀30处于静止位置，因此尚未抽取血液。可压下部26上的凸起33由凸轮32接合，并且不能向下移动。在图17B中，柳叶刀30已经接合并操作，并且已经移动到安全的静止位置31。现在可以将血液收集在收集装置28中。凸轮32仍然阻挡凸起33。
在图17C中，臂25已经旋转，使得血液可以经由开口20沉积到测试材料60上。凸轮32现在已经旋转，使得凹槽34位于凸起33附近，并且可压下部26现在可以向下移动，以在盒40上施加压力并排放流体(在该视图中未示出)。因此，凸轮32用作互锁装置以防止测试流体的过早排放。应当理解，可以使用其它机械系统来实现这一点。在上面引用的申请人的专利申请中提供了这种机构的示例。在许多情况下，流体的输送时间对于正确的结果是至关重要的，过早排放将使测试无效。
从图6和图7A，7B和7C可以更好地理解整个系统的操作及其排放。图6是部分剖视的平面图，以便可以更好地理解流体流动路径中的部件的布置。可以看到盒40，流体贮存器43容纳测试流体41。流体贮存器43通过排放管道52连接到井50，排放管道52最初被易碎密封55阻挡。当通过可压下部26向流体贮存器43施加足够的力时，易碎密封失效，流体通过排放管道52流入井50中。井50包括出口51。在该实施方式中，出口51直接排放到测试材料60的区域61上。参考图4，可以看出在该实施方式中缓冲液在点61处排放，使得它将穿过已经沉积血液样本的区域62，以便于测试。然而，应当理解，通过适当的相对定位，可以提供测试流体和样本的不同排序和定位。
图7A，7B和7C更详细地示出了说明性装置中的测试流体排放的顺序。
在图7A中，流体输送贮存器43容纳测试流体41并且尚未通过来自可压下部26的压力排放。这是供应测试装置的条件，并且在这种状态下，测试流体41通过易碎密封55完全密封在流体输送贮存器内，从而保持测试流体的所需组成和条件。
在图7B中，可压下部26已被压下，使得流体贮存器43已经通过管道52有效地排空，并且测试流体41被排放(如箭头57所示)到井50中。井50在区域61处直接与测试材料60接合。应当理解，在其它实施方式中，可以采用不同的流体流动路径和几何形状。
然而，发明人已经确定，通过流体路径中表面效应、表面张力和表面的其它流体粘附，使用直接排放和最小化介入流体路径使得保留在流体路径中的流体的体积最小化。虽然这不是必需的，但是最小化这些损失允许输送更准确的测试流体体积并且减少浪费。
在图7C中，测试流体41以受控方式通过开口51排放到测试部件60上。因此，测试流体41以测量的、受控的方式排放到测试部件60上，而不是以不受控制的快速输送方式。因此，井50用作控制容器，并且允许控制测试流体41的速率。
应当理解，虽然流体将随时间排放，但它不一定是以恒定的速率。速率将部分地由井中的开口(或多个开口)的尺寸以及测试材料的吸收来确定。例如，当更多或大部分流体离开容器时，流动可能变慢。
在优选实施方式中，本发明人已经确定，有利的是，井的体积小于流体贮存器的体积。这允许可压下部26的压下在一段时间内施加力，以从流体贮存器43中的流体41通过井50、出口51在区域61向测试材料内提供正压力。这随之提供了一致的测试流体41流入测试材料60。这也更积极地迫使流体进入测试材料。在该实施方式中，测试材料60通过毛细管作用将测试流体41吸入测试材料60中并沿测试材料60吸引，使得可以从井50中并且最终从贮存器43吸入进一步的流体。
还应当理解，流体应尽可能直接接触测试材料，并且期望可以控制测试流体41的体积以提供一致的输送体积，以及一致且正确的总输送量。这通过井50的体积小于贮存器43的体积来促进。如将在下面参考图11更详细地描述的，通风口111有利地设置在井50，102上方的密封中。如果没有提供通风口，则当测试流体41被分配到测试材料60上时，空气不能进入以替换测试流体41。这随之可以产生压力锁定，防止或阻止测试流体41传递到测试材料60上，或由于在输送的流体后面积聚的压力而输送到测试材料外部的流体离开井。
通风口111还有助于另一方面。在一些情况下，用户可能施加足以过度压缩贮存器43的压力。这可能导致在测试单元10内部流体“爆炸”的不受控制的快速爆发，因此流体总体被输送到内部而不是以期望的受控方式输送到测试材料60。在本例中，通风口111提供了用于使过量流体压力排放的方式，而不会使整个流体贮存器43失效。
为了促进流动，有利的是在出口51和区域62之间存在良好的流体接合。如果接合松动，则测试流体41可能在装置内排放而不是排放在测试材料上，这是不期望的。
在该实施方式中，另一个特征是在可压下部26和测试单元之间提供互锁装置，因此，一旦被致动，可压下部就停留在压下位置并且贮存器43被压缩。
首先参考图4，测试条单元10包括前凸起36。它位于可压下部26的正前方。可压下部26还包括在基部具有脚38的下凸起37，并且具有倾斜面(angled face)39。
图6A示出了可压下部26被致动之后的情况。流体已被迫或正在被迫从贮存器43进入井50中。脚38已被迫越过凸起36的顶部边缘，并且凸起36现在与倾斜面39接合。因此，可压下部26现在保持在压下状态，从而保持贮存器43上的压力。这种保持还可以防止流体返回到贮存器中的任何可能性，或者保持贮存器上的压力并因此迫使流体通过井50并进入测试材料60的力将不会被保持。这样，该互锁装置特征有助于确保将流体受控制地输送到测试材料60。
此外，期望在流体贮存器内尽可能少地存在空气。当可压下部26接合时，这允许当可压下部26接合时，用户经由可压下部26施加的力直接作用在测试流体上，而不是首先压缩盒40内的空气。减少密封的贮存器43内的空气含量减少了使用排放测试流体41所需的爆发力。从可用性的角度来看，需要较小的爆发力，因为用户操作和控制更容易。较大的爆发力意味着用户必须更用力地按压，这在某些情况下可能是物理上地困难的，并且增加了对测试单元的无意损坏的风险，或者由于过大的力而导致的不受控制的测试流体排放。这类似地允许封装更可靠的操作，并因此允许整个装置更可靠的操作。
小袋中的流体可以是执行、辅助或验证测试所必需或期望的任何种类的流体。应当理解，流体可以具有不同的特性，例如密度、粘度和表面张力，并且可能需要对盒进行适当的改变。本发明涉及如何输送流体，并且适用于与测试一起使用的任何期望的流体。
对于血液的成分、电解质、血糖、胆固醇或任何其它血液成分，测试材料可以是说明性的横向流动测试。它可以适于检测特定的生物学或免疫学反应，例如病原体或病原体的抗体的存在。可以使用适用于这种类型的测试单元的任何种类的体液测试。本发明并不特定于任何类型或形式的测试材料，无论是横向流动型还是其它形式。类似地，它不限于血液，而是可以应用于任何合适的体液(例如尿液、组织液、粪便或痰液)的测试，无论是直接施加到测试单元还是在预处理之后。本发明还可以应用于其它化学和生物化学测试，例如在工业、实验室或其它应用中。
应当理解，对于特定应用，特定尺寸、形状和参数将需要部分地通过试验和误差来确定。所需的流体体积将决定流体贮存器的尺寸。特定流体的特性和所需的流速将决定井中所需出口的尺寸和性质。还需要考虑特定流体与其将流过的材料之间的相互作用的表面特性。例如，在含水流体中，给定相对高的表面张力，优选平滑形状而非角部，以确保流体的平稳流动。所示的井50完全容纳在测试单元内，然而，应当理解，如果需要，其可以部分地打开。对于所使用的特定测试材料，所需的流速和体积是特定的，并且通常由测试材料制造商建议。
图8示出了根据本发明的盒40的一种形式。它包括容纳测试流体41的贮存器43，其通过管道52连接到井50。在图8中，盒40充满测试流体。从剖视图中可以看出，贮存器43内有很少或没有空气。易碎密封55为贮存器43提供密封，直到需要流体排放的时间为止。
图9示出了在测试流体41已经排放到井50中之后的图8的装置。因此，贮存器43现在基本上已经排空。施加到贮存器43的力已经升高了测试流体41中的压力，使得易碎密封55已经失效，并且测试流体41已经通过管道52进入井50中。然后，流体41以受控的速率从井50排放，如图9中的箭头所示。应注意，为清楚起见，立体图相对于剖视图是颠倒的。
图10仅示出了相对于测试条60的盒40和井50。井50与测试条的直接接合确保了测试流体41以最小的流体损失风险被排放到所需位置61上。
图11示出了根据本发明的一个实施方式的组装之前的盒的部件。示出了形成盒的上密封117和本体110的空的空白部件。在密封之前，贮存器凹槽101必须填充所需的测试流体41(为清楚起见，在此和后面的视图中未示出)。井结构102和通风口111也是可见的。
应理解，可使用任何合适的技术提供小袋或贮存器。然而，以下讨论涉及使用多层材料的热密封方法形成盒40。
盒可以由任何合适的材料形成。应当理解，材料必须与流体相容，并且相对于流体是惰性的。优选热密封箔聚合物。聚合物提供热密封，并且箔层有助于保护和保存流体。应当理解，在本申请中，流体体积小，盒的高不渗透性对于存放时间和保持适当的流体性质是重要的。
对于水性缓冲溶液，用于顶部密封的合适材料是可剥离的箔层压材料，产品代码RFA 037，可从Amcor Flexibles商购获得。这是一种可热密封材料，具有PET、粘合剂、铝和聚乙烯层。材料具有约60μm的标称厚度。
用于基部(贮存器和井)的合适材料是可冷成形的层压材料Formpak 3-ply，产品代码13355，可从Amcor Flexibles获得。这是具有铝、OPA和PE层的可冷成形材料，标称厚度为约100μm。
以下讨论特别涉及本发明应用于容纳小流体体积的盒，所述流体体积通常在约50至250μl的范围内，通常约200μl。
一般而言，优选的制造工艺是由合适的材料形成上密封117和本体110，然后将它们热密封在一起，并通过二次热密封部形成易碎密封121。已经确定使用单个过程做这个是不切实际的。易碎密封必须具有良好控制的强度。用于本体110的优选材料包括箔层，已经发现箔层导热超过期望的密封界限。结果是，这种方法不能生成良好形成的密封。
发明人采用了优选的两阶段制造过程。在该过程中，首先形成周边密封，在图12中标识为120。这不会对易碎密封进行密封，而是将盒110的外周边密封。从图13中可以更清楚地看出，将会形成流体管道和在成品中被密封的区域103在此不被密封。在第二阶段中，形成相对窄的辅助密封121，如图14所示。
本发明人已经确定了另一方面。即使在两阶段过程中，也可通过箔传热，从而在管道区域中产生一定程度的密封。这主要是因为它非常窄，并且从加热工具到第一阶段不希望密封的区域的距离很小。重要的是，在第一阶段中防止顶层和底层之间的热传递，以在第二阶段中实现可靠的密封。如果在第一阶段密封管道区域，则无法正确控制密封质量及其参数，因此，不能可靠地控制或预测密封的爆发力。这是通过两个单独的改进来解决的。
应当理解，如果顶层和底层接触，则密封只能在顶层和底层之间形成并被加热。热导致密封层的激活，因此可能产生不受控制的密封，其中，所述密封层在本实例中是PE层。
在一个方面中，管道区域形成有较大的曲率，使得管道周围的表面不接触，因此不太可能导致不希望的热传递，而所述不希望的热传递可能导致管道区域的密封。应当理解，在替代设计中，对管道形状的修改可以是对密封、本体或两者。
在第二方面中，工具不仅形成有围绕管道部的开口，而且具有开口部，以进一步减少通过传导或辐射传递到管道部的不希望的热量，以消除管道区域的任何密封。这与由第一方面产生的层之间的物理间隙配合，以在层接触时有效地消除热传递的可能性，并因此防止第一阶段中的管道密封。
这可以在图15中看到。应当理解，工具的外部尺寸将由设计用于其的机器决定，因此这些仅以示意性方式示出。还应当理解，虽然示出了单个腔，但是可以遵循所概述的一般原理使用多腔工具。
盒110(密封不容易看见，但当然是存在的)的部件被定位成使得上部工具130和动力工具131能够移动到操作位置，大致抵接盒110。可以看出，上部工具包括凹槽132，凹槽132限定了非密封区域，并且该凹槽在顶部是开口的134。在下部工具131中的凹槽133中存在类似的布置。因此，这些工具协作以接触、加热盒部件的材料，并产生密封，如图12和13所示。也就是说，尚未形成易碎密封121。
图16示出了根据该实施方式的盒的生产的第二阶段。上部工具140和下部工具141包括相应的叶片型部142，143。当移动到位时，它们通过热密封盒的相应部分而形成相对窄的密封，从而提供易碎密封121。
应当理解，虽然已经示出了盒及其子部件具有可与所述机械系统一起操作的特定形状，但是对于不同的系统和应用，可以预期形状、体积、尺寸等等将根据盒的特定致动布置而变化。
图18A，18B和18C使用纵向剖视图示出了上述密封阶段。在图18B中，在将流体添加到贮存器41之前，可以看到贮存器40和井50。排放管道52限定在层52A，52B之间，如上所述，这在使用中将有助于流体转移到井50。
在图18B中，已经添加了流体，并且外围密封已经完成，但是管道52保持打开并且表面52A和52B保持分离。在图18C中，易碎密封55由叶片142，143形成(在该视图中不可见)。因此，层52A，52B被迫在一起并且密封作为相同过程步骤的一部分而形成。
因此，该实施方式允许严格控制测试流体的输送速率。首先将流体排放到井中。出口的尺寸、数量和形状以及井的形状将决定流体排放的速率(可变的或恒定的)。与盒的其余部分的相互作用，由可压下部施加的压力以及整个流体流动路径将影响流速。例如，如果出口相对较小，则流体将在较长时间段内排放。控制流体体积及其流体路径的组合允许相对精确地控制流体的输送，并进一步确保将其输送到测试材料上的正确点。
本发明可以以不包含与上述实施方式相关的所有优选特征的方式实施。所描述的本发明的各个方面在不包含所描述的实施方式的所有部件的情况下具有优点。例如，血液或其它流体样本可以在不使用样本输送臂或其它机构的情况下直接放置在测试单元中的合适凹槽或开口中。盒可以由用户插入测试单元而不是一体的。
应当理解，说明性实施方式仅作为示例提供，并且许多其它结构可用于实现本发明。例如，所描述的盒可以与所描述的那些不同的机械结构一起使用，并且用于与所讨论的那些完全不同的应用。

Claims (13)

1.一种集成测试装置，包括：
测试部件(60)；和
流体输送致动器；
其特征在于，所述装置还包括：测试流体模块，其包括容纳测试流体(41)的贮存器(43)、具有一个或多个出口(51)的输送容器和连接所述贮存器(43)与所述输送容器的管道(52)；以及在所述管道(52)上的易碎密封(55)；并且
在于，所述流体输送致动器的操作引起所述测试流体(41)从所述贮存器被迫破坏所述易碎密封(55)并且进入所述输送容器中，所述输送容器适于将所述测试流体(41)的受控排放从所述一个或多个出口(51)提供至所述测试部件(60)上，排放速率由来自所述一个或多个出口(51)与所述测试部件(60)的接合的所述测试流体(41)中的背压来控制。
2.根据权利要求1所述的集成测试装置，其中，所述流体输送致动器包括互锁结构，使得一旦被致动，所述流体输送致动器就保持在致动位置，以将来自所述流体输送致动器的力保持在所述测试流体(41)上，直到所述测试流体(41)已经从所述贮存器(43)排放，并且包括另一互锁机构以防止所述测试流体(41)的过早排放。
3.根据权利要求1或2所述的集成测试装置，其中，所述输送容器包括与所述一个或多个出口(51)分开的孔，以允许通气和进气。
4.根据权利要求1所述的集成测试装置，其中，所述贮存器(43)的体积大于所述输送容器的体积。
5.根据权利要求1所述的集成测试装置，其中，所述一个或多个出口(51)直接排出到所述测试部件(60)上。
6.根据权利要求1所述的集成测试装置，其中，所述模块形成为整体单元。
7.根据权利要求1所述的集成测试装置，其中，所述测试是对体液或材料进行的医学测试，所述体液或材料包括新鲜血液、血清、血浆、唾液、痰液或尿液。
8.一种输送用于进行集成测试的测试流体(41)的方法，至少包括以下步骤：
提供测试单元(10)，所述测试单元(10)包括测试部件(60)、流体模块、在管道(52)上的易碎密封(55)以及流体输送致动器，其中，所述流体模块具有容纳测试流体(41)的贮存器(43)、包括一个或多个出口(51)的输送容器，和连接所述贮存器(43)和所述输送容器的所述管道(52)；
操作所述流体输送致动器，从而在所述贮存器(43)上施加压力，以破坏所述易碎密封(55)；
由于所述贮存器(43)上的压力，将所述测试流体(41)从所述贮存器(43)释放到所述输送容器中；
从而提供从所述一个或多个出口(51)到所述测试部件(60)上的测试流体(41)的受控排放，布置成使得所述流体输送致动器可操作性地迫使测试流体(41)进入所述输送容器，然后通过所述一个或多个出口(51)并进入所述测试部件(60)，排放速率由来自所述一个或多个出口(51)与所述测试部件(60)的接合的所述测试流体(41)中的背压来控制。
9.根据权利要求8所述的输送用于进行集成测试的测试流体(41)的方法，其中，所述流体输送致动器包括互锁结构，使得一旦被致动，所述流体输送致动器就保持在致动位置，以在所述贮存器(43)上施加力并且保持所述力直到所述测试流体(41)已从所述贮存器(43)排放。
10.根据权利要求8至9中任一项所述的输送用于进行集成测试的测试流体(41)的方法，其中，另一互锁机构防止所述测试流体(41)的过早排放。
11.根据权利要求8所述的输送用于进行集成测试的测试流体(41)的方法，其中，所述一个或多个出口(51)直接排放到所述测试部件(60)上。
12.根据权利要求8所述的输送用于进行集成测试的测试流体(41)的方法，其中，所述贮存器(43)的体积大于所述输送容器的体积。
13.根据权利要求8所述的输送用于进行集成测试的测试流体(41)的方法，其中，所述测试是对体液或材料进行的医学测试，所述体液或材料包括新鲜血液、血清、血浆、唾液、痰液或尿液。
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