CN110075939B - 生物流体微样本管理装置 - Google Patents

生物流体微样本管理装置 Download PDF

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CN110075939B
CN110075939B CN201910447661.1A CN201910447661A CN110075939B CN 110075939 B CN110075939 B CN 110075939B CN 201910447661 A CN201910447661 A CN 201910447661A CN 110075939 B CN110075939 B CN 110075939B
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housing
sample
biological fluid
collection module
collection device
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CN110075939A (zh
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M·伊沃塞维克
K·K·博卡斯里尼瓦萨劳
P·斯库特尼克
A·V·托里斯
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Abstract

本发明涉及一种生物流体收集装置，其包括收集模块和外部壳体。收集模块包括壳体，该壳体包括具有样本引入开口的第一端部、具有样本分配开口的第二端部、以及在样本引入开口和样本分配开口之间延伸的通道。混合腔室和保持腔室能够与通道互通流体，从而被引入样本引入开口的样本通过混合腔室，然后进入保持腔室中。生物流体收集装置还包括覆盖第一端部的闭合件、覆盖第二端部并包括通气塞的盖帽、以及适于迫使保持腔室中的样本从样本分配开口排出的致动构件。收集模块位于外部壳体内，并且闭合件封闭外部壳体的敞开端部。

Description

生物流体微样本管理装置
分案说明
本发明专利申请是一个分案专利申请。
本分案专利申请的原始申请，是国际申请日为2016年3月9日、国际申请号为PCT/US2016/021527、中国国家申请号为201680002463.9、发明名称为“生物流体微样本管理装置”的发明专利申请。
相关申请的交互引用
本申请要求2015年3月10日提交的美国临时专利申请第62/130,878号(标题为“Biological Fluid Micro-Sample Management Device”)的权益，该申请通过引用的方式整体并入于此。
技术领域
本发明涉及一种生物流体收集装置，具体是一种血液收集装置，其用于收集小型血液样本并将该样本的一部分分配到被设计用于分析该样本的装置例如即时检验(point-of-care)或者患者就近检验(near-patient-testing)装置之中。
背景技术
需要这样一种改进型装置，其能够收集微样本(例如小于500微升的分析用被收集样本)，例如患者即时检验应用场合。目前的装置要求常规型样本收集，并之后用1ml的注射器或者试管将小型血液样本传送至即时检验筒或者设备接收端口。这种开放式系统方法使得执行检验的人员暴露于血液的风险增加，还要求收集多余的样品来执行专门的检验程序。
因此，期望的是提供这样一种用于即时检验应用场合的血液样本收集和分配工具：其与常规式自动采血相结合，并在使得暴露风险最小化的同时具有新颖的受控式样本分配能力。
发明内容
本发明涉及生物流体收集装置，其包括收集模块和外部壳体。该收集模块包括壳体，该壳体具有带样本引入开口的第一端部、带样本分配开口的第二端部、以及在样本引入开口与样本分配开口之间延伸的通道。混合腔室和保持腔室与该通道能够互通流体，从而被引入到样本引入开口的样本通过混合腔室，并随后进入保持腔室中。收集模块还包括：闭合件，该闭合件覆盖所述壳体的第一端部；盖帽，该盖帽覆盖所述壳体的第二端部并具有通气塞；以及致动构件，该致动构件适于迫使容纳于保持腔室中的样本从样本分配开口排出。收集模块位于外部壳体内，并且收集模块的闭合件封闭外部壳体的敞开端部。
混合腔室可以包括置于其中的抗凝剂。该混合腔室还可以包括开孔泡沫。
所述盖帽可以包括通气塞，例如多孔塞，其允许空气通过但阻止血液样本通过。在壳体的通道充填有血液时，通气塞可以阻止血液样本流入到收集装置之中。
比起保持腔室来，混合腔室可以更靠近壳体的第一端部，从而被引入样本引入开口的血液样本在进入保持腔室之前通过混合腔室。
保持腔室可以由包围一部分壳体的弹性套筒以及壳体中的凹陷部限定，并且致动构件可以至少是弹性套筒的用以限定保持腔室的那一部分。当从收集装置移除盖帽并且在弹性套筒的用以限定保持腔室的那一部分上朝壳体中的凹陷部施加向内压力时，会将保持腔室内的血液样本从样本分配开口排出。
附图说明
图1是根据本发明一个方面的生物流体收集装置的主视立体图，该装置具有设在外部壳体内的收集模块。
图2是图1生物流体收集装置的部分剖视立体图。
图3是根据本发明另一方面的生物流体收集装置的主视立体图，其具有置于外部壳体内的收集模块。
图4是图3生物流体收集装置的部分剖视图立体图。
图5A是图1生物流体收集装置的部分剖视立体图，根据本发明另一方面，该装置被插入到管状保持件中。
图5B是图1生物流体收集装置的部分剖视立体图，其中生物流体样本通过管状保持件流入收集模块中。
图5C是图1生物流体收集装置的部分剖视立体图，根据本发明一个方面，该装置从管状保持件移除。
图5D是图1生物流体收集装置的收集模块，其中，根据本发明一个方面，收集模块从图1的外部壳体移除。
图5E是图1生物流体收集装置的部分剖视立体图，其中，根据本发明一个方面，盖帽从收集模块移除。
图5F是图1生物流体收集装置的收集模块的致动构件的部分剖视立体图，其中，根据本发明一个方面，收集模块的致动构件被致动以将生物流体从收集模块分配出。
图6是根据本发明另一方面的生物流体收集装置的下端部的部分立体图，该装置具有设置在外收集壳体内的生物流体收集模块。
图7是图6生物流体收集装置的下端部的部分剖视立体图。
图8是根据本发明另一方面的生物流体收集装置的立体图。
具体实施方式
提供下文的说明以使得本领域技术人员能够制造和使用用于实施本发明的所描述实施例。然而，各种变型、等同内容、变化和备选方案对本领域技术人员来说是显然的。任何所有这种变型、变化、等同内容和备选方案将落入本发明的精神和范围之内。
为了下文的描述，术语“上”、“下”、“右”、“左”、“竖直”、“水平”、“顶”、“底”、“横向”、“纵向”以及它们的衍生词，将涉及本发明在附图中的取向。然而，要理解的是，除明确表示相反之外，本发明可以采用各种备选变化。还需要理解的是，在附图中示出并在下文描述的特定装置仅是本发明的例示性实施例。因此，与本文所披露的实施例相关的特定尺寸和其它物理特征不应被认为是限制性的。
参见图1和图2，一种生物流体收集装置包括收集模块10，该收集模块置于外部壳体34中。收集模块10适于接收生物流体样本(例如血液样本)，并且该收集模块包括壳体12、闭合件14、混合腔室16、保持腔室18、盖帽20以及致动构件22。
在一个实施例中，壳体12包括第一端部24、第二端部26、以及在第一第二端部之间延伸的通道28，该通道提供在壳体12的第一端部24和第二端部26之间的流体连通。该通道28具有在壳体12的第一端部24处的样本引入开口30、以及在壳体12的第二端部26处的样本分配开口32。混合腔室26和保持腔室18被设置成能够与通道28互通流体。混合腔室16和保持腔室18被定位成使得被引入到通道28的样本引入开口30中的生物流体样本(例如血液样本)将首先通过混合腔室16，然后通入保持腔室18中，再到达通道28的样本分配开口32。由此，血液样本可以与混合腔室16内的抗凝剂或者其它添加剂混合，然后被稳定化的样本被接纳并储存在保持腔室18内。
在血液样本流经通道28时，混合腔室16允许血液样本与抗凝剂或者另一添加剂(例如血液稳定剂)被动地混合。混合腔室16的内部部分可以具有任何合适的结构或者形式，只要其能够在血液样本通过通道28时将血液样本与抗凝剂或者另一添加剂混合即可。混合腔室16可以包括设置在混合腔室16上或者内的干燥的抗凝剂，例如肝素(Heparin)或者EDTA。混合腔室16例如可以包括开孔泡沫(图1)，其容纳有置于开孔泡沫的孔内的干燥抗凝剂，从而增进流经混合(flow-through mixing)和抗凝剂吸收的有效性。
开孔泡沫可以用抗凝剂处理从而形成细密地遍布于开孔泡沫的孔内的干燥抗凝剂粉末。当血液样本进入混合腔室16时，血液样本通过开孔泡沫，并与遍布于开孔泡沫的内部孔结构上的抗凝剂粉末接触。
开孔泡沫可以是对血液呈惰性的柔性可变性开孔泡沫，例如三聚氰胺泡沫(诸如可以从BASF购买到的
Figure BDA0002074141620000051
泡沫之类)，或者可以包括甲醛-三聚氰胺-亚硫酸氢钠共聚物。开孔泡沫可以是柔性的亲水性开孔泡沫，其基本上能够耐受热和有机溶剂。在一个实施例中，泡沫可以包括海绵材料。
抗凝剂或者其它添加剂可以通过以下方式引入到开孔泡沫中，即，将泡沫浸在添加剂和水的液态溶液中，之后将水蒸发，形成细密地遍布于泡沫内部结构上的干燥的添加剂粉末。
血液样本在通过混合腔室16之后可以被引导至保持腔室18。保持腔室18可以采用任何合适的形状和尺寸，从而储存进行所期望检验所需的充分量的血液(例如500μl或者更少)。在图1和图2所示的实施例中，保持腔室18由壳体12的一部分与紧固于壳体12外部周围的弹性套筒40一起限定。弹性套筒40可以由任何柔性的、可变性的材料制成，该材料能够提供与壳体12的不透流体的密封，该材料包括但并不限于天然或者合成橡胶以及其它的合适的弹性体材料。壳体12包括凹陷部42，该凹陷部从壳体12的外部延伸至通道28，有效地形成壳体12中能够与通道28互通流体的开口。弹性套筒40覆盖凹陷部42，限定出具有500μl或者更少的内部充填容积的保持腔室18。
盖帽20设置在壳体12的第二端部26上，覆盖住通道28的样本分配开口32。盖帽20包括通气塞，例如多孔塞44，其从盖帽20的内部表面延伸至盖帽20的外部表面。通气塞44的构造使得空气能够通过盖帽20，同时防止血液样本通过盖帽20，并且该通气塞可以包括疏水性过滤器。通气塞44具有选定的空气通过阻力，从而可以用于精密地控制通道28的充填速度。通过改变通气塞的多孔性，空气流出盖帽20的速度以及血液样本流入收集模块10的速度可以受到控制。如果进入收集模块10的血液样本流动速度过快，会发生溶血现象。如果进入控制模块10的血液样本流动速度过慢，样本收集时间会过长。
闭合件14与壳体12的第一端部24接合，从而密封住通道28。闭合件14能够将血液样本引入到他壳体12的通道28之中，并且可以包括可穿透的自密封止挡件36，该止挡件具有外遮护件38(例如可从Becton,Dickinson and Company购得的HemogardTM盖帽)。闭合件14还紧固至外部壳体34，该外部壳体可以是抽真空的血液收集管，例如可从Becton,Dickinson and Company购买的
Figure BDA0002074141620000061
血液收集管)。
盖帽20设置在壳体12的第二端部26处，并还可以包括凸缘46以帮助使用者从壳体12移除盖帽20。如图2所示，凸缘的外直径可以小于外部壳体34的内直径，在外部壳体34内可以放置收集模块10。或者，如图6和图7所示，凸缘46的外直径可以大致等于外部壳体34的内直径。在该配置中，凸缘46可以包括凹陷部或者缝槽48，其从上表面延伸至下表面，从而使得外部壳体34内的真空围绕凸缘46通过。此外，如图6和图7所示，凸缘46可以由透光材料制成，并可以具有凸形的外直径表面，从而其能够放大盖帽20的通气塞44区域，允许医护工作者能够知悉血液样本在何时完全充填通道28并到达盖帽20。凸缘46还可以与外部壳体34的内壁的凹陷部接合，从而与外部壳体一起固持住盖帽20。
使用时，针插管50(图5A和图5C)经由样本引入开口30(例如通过闭合件14的可穿透的自密封式止挡件36)插入到壳体12的通道28中。如图5A所示，相组合的收集模块10和外部壳体34可以插入到常规的管保持件52中，生物流体可以通过该管保持件所具有的插管。
生物流体样本在外部壳体34内含有的真空的吸力下从常规的管保持件52被拉入到壳体12的通道28中(图5B)。血液样本通过首先进入混合腔室16并之后进入保持腔室18而装填整个通道28，并将通道28中的任何空气驱逐到外部壳体34中。如上文所述，生物流体样本在其通过混合腔室16时与至抗凝剂或者其它添加剂接触并与其混合。在收集模块10的通道28、混合腔室16和保持腔室18完全填满后，盖帽20停止血液样本的收集。盖帽20的通气塞44阻止血液通入到外部壳体34内。
一旦完成血液收集，包括收集模块10的外部壳体34与管保持件52(图5C)分离，然后，通过将闭合件14(其仍然附接至收集模块10)从外部壳体34移除，使外部壳体34与收集模块10(图5D)分离。使用者可以通过抓握闭合件14的外遮护件38和外部壳体34二者并且沿相反的方向拉动或者扭转它们，而完成闭合件14的移除。
一旦收集模块10与外部壳体34分离，就可以将盖帽20从收集模块10(图5E)移除，将壳体12的第二端部26露出。该移除操作可以通过使用者抓持凸缘46并从壳体12拉动盖帽20而实现。在移除了盖帽20之后，在毛细作用下，血液样本被保持在壳体12的通道28中。或者，可以在将收集模块10从外部壳体34移除时，将盖帽20移除。在该配置中，在凸缘46与外部壳体壁的相应凹陷部的相互作用下，盖帽20被固持在外部壳体34内。在另一实施例中，盖帽20可以连接至外部壳体34，从而可以在一个步骤中将外部壳体34和盖帽20移除。
然后，通过将致动构件22致动(例如通过沿箭头方向对覆盖保持腔室18的弹性套管40施加向内压力，将血液样本排出保持腔室18并通过样本分配开口32(图5))，而将血液样本从收集模块10分配出去(图5F)。以此方式，血液样本可以经由端口被传送至用于分析样本的装置(例如即时检验装置例如筒式检验器)，同时使医护工作者暴露至血液样本的风险得以最小化。
虽然弹性套筒40的一部分被示出并描述成部分地限定保持腔室18并用作致动构件22以将血液样本从收集模块10分配出去，还可以构想到其它备选的用于实现相同结构的方式。例如，保持腔室18可以由壳体12完全地限定，并且与保持腔室18接合的单独的致动装置(包括但不限于栓塞、推动按钮、滑动件等)可以被致动，从而分配血液样本。
在另一实施例中，如图3和图4所示，闭合件14可以具有通过止挡件36的鲁尔锁连接件54。当从动脉吸取血液样本时(此时，无需像对静脉血液收集而言是必需的那样，利用真空将血液样本拉动进入收集模块100)，上述构造是有用的。收集模块100以与收集模块10相同的方式使用，除了鲁尔锁连接件54被用于将收集模块100连接至翼形套件或者其它连接器件(其具有匹配的鲁尔锁连接件)以将血液样本引入到通道28中之外。
还可以在没有外部壳体34的情况下使用收集模块10、100。在收集模块10的情况下，可以使用注射器或者其它动力源而将样本吸入收集模块10中。此外，虽然本文的讨论主要集中于使用收集模块10、100来收集血液样本并将其与抗凝剂或者其它添加剂混合，然而收集模块10、100还可以用于收集其它液体样本(例如其它体液)，或者可以用于对已由其它装置收集到的样本进行混合和分配。
在另一配置中，收集模块10可以包括标记56a、56b，所述标记附着至闭合件14和外部壳体34二者，需要将标记断裂以将收集模块10从外部壳体34移除。如图1-4所示，标记56a可以是条形件，该条形件仅沿外部壳体34和闭合件14外周边的一部分而延伸。将闭合件14相对于外部壳体34扭转，使得条形件在从外部壳体34过渡到闭合件14的位置处断裂。在标记45a从外部壳体34过渡到闭合件14的位置处中可以设置穿孔58，从而有助于在扭转闭合件14时让条形件断裂。或者，如图8所示，标记56b可以围绕闭合件14和外部壳体34二者的整个周边。在标记56b从外部壳体34过渡到闭合件14的位置处可以设置一些穿孔58，这些穿孔形成围绕闭合件14的带60，该带可以从标记56b围绕外部壳体34的部分分离。将带60从闭合件14移除可以使得闭合件14从外部壳体14移除。在带60上可以设置拉片62，以帮助将带从标记56b围绕外部壳体34的部分移除。
虽然已详细地描述了本发明装置的具体实施例，本领域技术人员将知晓的是，可以在本发明总体教导之下，开发出各种变型和备选方案。因此，所披露的特定设置是示意性的，并非用以限制本发明装置的范围。本发明的范围将由权利要求书的及其任何所有等同内容的完整宽度上限定。

Claims (9)

1.一种生物流体收集装置，该生物流体收集装置包括：
收集模块，该收集模块包括：
壳体，该壳体包括：
具有样本引入开口的第一端部；
具有样本分配开口的第二端部；
在所述样本引入开口与所述样本分配开口之间延伸的通道；以及
能够与所述通道互通流体的保持腔室；
覆盖所述壳体的第一端部的闭合件；
覆盖所述壳体的第二端部的盖帽，所述盖帽允许空气通过所述盖帽，同时防止生物流体通过所述盖帽；
致动构件，该致动构件限定所述保持腔室的至少一部分并且适于迫使所述保持腔室中容纳的样本从所述样本分配开口排出；以及
外部壳体，该外部壳体具有敞开端部和闭合端部，
其中，所述收集模块位于所述外部壳体的内部，并且所述闭合件封闭所述外部壳体的敞开端部，并且
围绕所述收集模块的所述外部壳体的内部含有真空。
2.根据权利要求1所述的生物流体收集装置，还包括能够与所述通道互通流体的混合腔室，其中，被引入所述样本引入开口的样本通过所述混合腔室并且然后进入所述保持腔室中。
3.根据权利要求2所述的生物流体收集装置，其中，所述混合腔室包括在所述混合腔室的内部的抗凝剂或者血液稳定剂。
4.根据权利要求2所述的生物流体收集装置，其中，所述混合腔室装填有开孔泡沫。
5.根据权利要求4所述的生物流体收集装置，其中，所述开孔泡沫包括海绵材料。
6.根据权利要求2所述的生物流体收集装置，其中，所述混合腔室比所述保持腔室更靠近所述壳体的第一端部，从而被引入所述样本引入开口的血液样本在通入所述保持腔室之前通过所述混合腔室。
7.根据权利要求1所述的生物流体收集装置，其中，所述壳体限定凹陷部，所述凹陷部从所述壳体的外部延伸至所述通道，所述凹陷部限定所述保持腔室的至少一部分。
8.根据权利要求1的生物流体收集装置，其中，所述致动构件包括弹性套筒，所述收集模块可移除地位于所述外部壳体的内部，所述保持腔室由所述壳体的一部分结合所述弹性套筒而限定，所述弹性套筒围绕所述壳体的外部而被固定，在所述收集模块从所述外部壳体中移除并且所述盖帽从所述收集模块移除之后，在限定所述保持腔室的所述弹性套筒的一部分上的向内压力迫使在所述保持腔室中的血液样本从所述样本分配开口排出。
9.根据权利要求1所述的生物流体收集装置，其中，所述盖帽包括通气塞，并且所述通气塞是多孔塞。
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