CN101420902B - 血液采集装置、方法以及使用其的系统 - Google Patents

血液采集装置、方法以及使用其的系统 Download PDF

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CN101420902B
CN101420902B CN2007800125594A CN200780012559A CN101420902B CN 101420902 B CN101420902 B CN 101420902B CN 2007800125594 A CN2007800125594 A CN 2007800125594A CN 200780012559 A CN200780012559 A CN 200780012559A CN 101420902 B CN101420902 B CN 101420902B
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G·D·弗莱彻
S·F·格林
M·洛佩斯
R·J·洛萨达
D·马努萨基斯
C·M·纽比
G·帕马
P·R·索斯基
T·A·史蒂文斯
吴宇光
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Becton Dickinson and Co
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Abstract

本发明公开了一种流体采集装置，其中，可以同时采集流体的多重、各个样本。该装置包括腔室和适配器，该适配器基本上同时将血液分配到具有腔室特定添加剂的各个腔室中。同时公开了一种优选在诊断检测实验室中使用该血液采集装置的系统。

Description

血液采集装置、方法以及使用其的系统
技术领域
本发明涉及一种体液采集装置，尤其用于采集全血。更具体地，本发明涉及一种流体采集装置，其中，可以同时提取来自相同源头的多重、各个流体样本。
背景技术
属于Columbus等人的美国专利5743861(用过引用结合在此)公开了一种类似于传统的血液采集管的圆筒形装置。当然，还需要进一步改进。
发明内容
本发明对属于Columbus等人的美国专利5743861所公开的实施例进行了改进。所提供的血液采集装置包括具有隔膜的盒，用于与体液采集阀或端口(例如血液采集针、导管端口、血液采集装置)连接，与刺穿的隔膜流体连通的歧管，与歧管流体连通的多个采集储存室，每个采集储存室具有在储存室内提供适当的环境条件的添加剂和/或表面改性和处理，从而获得用于检测的血液或样本的稳定性，其也成为检测的一部分。在某些实施例中，每个储存室被设计成不需要真空驱动力就能使样本从患者移动到储存室中。
本发明还公开了一种分析器，该分析器接收盒并随后将被分装的样本从该盒的多个采集储存室抽取到检测类型(凝固、血液学、临床和/或免疫化学)特定的各个样本器皿中。
本发明还公开了一种血液分析器，其中，该分析器接收盒并且在该分析器内能够对尤其是来自单个采集盒的样本执行凝固、血液学、临床和/或免疫化学分析。
此外，本发明还公开了一种用于分装生物流体的方法，该方法包括以下步骤：接收一盒，该盒包括多个内部腔室，该腔室的容积和表面专用于至少两种类型的样本，其中该样本选自由凝固、血液学、免疫化学和临床化学分析样本构成的组；和从腔室中的至少两个，将临时驻留在每个腔室中的至少一部分生物流体分装到每个腔室的至少一个唯一的分装试管中。该盒上可存在标识，其中在分装之前通过扫描部件查询该标识。例如，该标识可为一维或二维的条形码。
附图说明
图1A示出了与本发明的实施例相关的持针器的立体图。
图1B示出了与本发明的实施例相关的盒的立体图。
图1C示出了图1B所描绘的盒的平面视图。
图1D示出了与本发明的实施例相关的仪器的立体图。
图2A示出了与本发明的实施例相关的持针器的立体图。
图2B示出了与本发明的实施例相关的盒的立体图。
图2C示出了图2B所描绘的盒的平面视图。
图3A示出了与本发明的实施例相关的仪器的立体图。
图3B示出了图3A所描绘的盒的平面视图。
图3C示出了与本发明相关的传输器皿的侧视图。
图3D示出了与本发明相关的特定检测器皿的侧视图。
图4示出了与本发明相关的流程图。
图5示出了与本发明相关的流程图。
具体实施方式
在此描述了一种血液采集装置，用于并行采集患者静脉血和将患者静脉血引入到密封的多腔室盒20中，同时防止腔室间的交叉污染。由于每个腔室与其它腔室隔离，每个腔室可包含化学试剂或添加剂，而在传统的真空试管中，所述化学试剂或添加剂需要单独的试管。本发明的血液采集装置允许借助于分配器同时填充每个腔室， 该分配器可以选择性地被设置为与多个真空腔室基本上同时流体连通。从而血液能够从源头通过歧管并进入腔室。
由于本发明的装置紧凑并且具有通常为矩形的纵向剖面形状以及采用非常类似于当前血液采集技术在流体驱动力上具有灵活性的方式进行作用，因此本发明的装置易于使用。具体地，该血液采集装置20被设计为与持针器12一起使用，因此当必要或期望时，该血液采集装置20可以与多重特定检测分析仪所使用的分装试管或容器240结合使用(例如，包含柠檬酸盐的旨在用于凝固检测的凝固分装试管或容器240a；包含EDTA的旨在用于血液学检测的血液分装试管或容器240b；或者包含凝块激活或者增强表面以实现内源性、外源性、或内源性和外源性凝块级联的临床化学分装试管或容器240c)。通过将所有期望的血液样本采集和包含在单个多腔室器皿中，一次性废弃物的数量能够被减到最少，并且由于可以不使用多个试管和辅助容器，因此可以改进明确的患者标识，而不需要对用于同一患者样本的多个容器加标签。此外，如以下详细描述的那样，本发明的实施例采用了生产简单且廉价的部件，尽管该装置具有复杂的性能。
该采集装置20可以以组成部件制造并在提取患者样本前进行组装，或者该采集装置20可以被预先组装好并且随时可使用。可以利用现有技术中的多种方法来制造该装置，然而，优选的方法是大部分部件利用合适的塑料被注塑模制而成的方法。这种塑料使得该装置轻便、不易碎并且可以适中的成本制造。此外，该采集装置优选由生物相容的、经美国食品和药品管理局(FDA)核准的、适合于血液样本、化学处理以及要执行的分析检测的塑料和金属部件制成。
该血液采集装置中的每个采集腔室的全部内部空腔以及分配器开口可以采用例如隔膜或自修复密封件密封。例如，在具有多个腔室42、44和46的采集装置20中，隔膜26、28和30分别能够在分别通过密封件被插入到每个腔室中的分装或抽取部件之间实现接合。这种密封件和隔膜在本领域是已知的并允许被尖状物例如针穿透，使得当取出尖状物时，该密封件基本上重新密封，以阻隔流体通道。 用于该密封件的合适材料在本领域是已知的，并且应基于该装置的旨在用途，例如生物相容性、化学惰性和与被包含在该装置中的任何一种化学试剂或处理相容、经FDA核准的、以及适于自动化仪器使用来进行选择。每个开口可以在抽真空后被单独密封。
在操作中，该血液采集装置20可与持针器组件12一起使用，该持针器组件12与传统的、抽真空的血液采集管(例如BectonDickinson and Company出售的VACUTAINERTM)使用的持针器组件相类似。所述盒具有远端22和近端24。在针头被插入血管后，位于该盒的远端22上的可穿透隔膜32被套管14穿透，从而将该盒中的流体歧管暴露于血源。腔室和歧管中的驱动力借助于由患者提供的静脉压力使血液通过套管14、高压室/歧管并抽取到各个腔室(42、44和46)或储存室中。当血流已经停止时，可以从持针器组件12上移除该多腔室体/适配单元，如同标准的、真空采集管步骤一样。随后可完全地从匹配器上拔走或移除该多腔室体，允许自修复隔膜32重新密封，从而提供了密封保存血液的多个腔室或储存室。
如图1B、1C、2B和2C所示，该盒20的近端24具有用于每个相应的储存室(如图1C中虚线所示的42、44和46)的至少一个抽取端口(26、28或30)。采用该抽取端口来将被保存在储存室中的每个血液样本抽取到图3A和3B所示的分装仪器200中，其中，该仪器抽取各个样本并将该样本传送到分离的、非一体的采集装置240中。该过程如图3A-3D所示。在已经从盒20抽取样本并将样本分装到不同的采集传输器皿240之后，可以采用该器皿240在稍后的时间在特定检测仪器中进行分析。
可供选择地，可以采用该抽取端口(26、28和30)来将被保存在储存室中的每个血液样本抽取到多重检测仪器中，其中，该仪器根据需要抽取样本并执行恰当的分析，而无论提取的样本是什么。在图1A-1D所示的实施例中，该仪器或许需要识别和区分用于某种类型的检测的样本在盒20中被定位的位置。在一个实施例中，该仪器能够将该盒定位到该仪器中并且该盒的几何形状仅允许一个方位，使 得该仪器总能识别出需要接入哪一个抽取端口，以特定地抽取所需样本。在另一个实施例中，该仪器可以扫描位于盒20上的标识符34(参见图1B的标识符)，以确定需要接入哪个抽取端口。上述两实施例由图1B和图3A-3D表示。
在本发明的一个实施例中，该盒的内部空腔可为真空或局部压力小于大气压。当在患者的血液与空腔之间建立流体连接时，这种真空的驱动力辅助从患者的血液流传送血液。为了保持真空，封闭空腔的侧壁和隔膜必须能在合理的时间期限例如一年内防止真空损耗。在本发明的一个实施例中，箔片密封件覆盖位于该盒内部空腔之间的隔膜，使得一旦箔片密封件破裂，空腔与患者血液间的压力趋于平衡，从而将血液样本提取到空腔以及各个储存室中。
如图1所示，该装配好的盒20接入与患者的血管流体连通的针14或者端口。该盒20的远端22被加工成允许该盒装配在持针器12的近端内的形状。该持针器12和盒20必须被加工成一旦建立连接就能使该盒被填充的形状。例如，如图1A所示，持针器12具有与盒20的远端22的形状相符合的几何形状例如槽。驱动力可以是静脉压力、盒内的局部真空、毛细作用、重力或其它类似的驱动力，使得适量的流体进入储存室，以便适当的填充。该盒20的近端24可以包括用于被包含在该盒内的每个储存室的至少一个抽取端口(26、28或30)。例如，具有三个储存室(即血液学储存室42、凝固储存室44以及临床化学储存室46)的盒将分别具有三个抽取端口26、28和30。
图4提供的流程图表明了本发明实施例的操作方式。在患者的体液与容器盒的端口之间建立流体连通(步骤410)。将体液引入到该盒中(步骤420)。该盒与分析器连接(步骤430)。最后，该分析器根据同一盒内的不同类型的样本进行多重检测(血液学、凝固、化学)(步骤440)。例如，该盒内的血液样本可以在腔室内包含EDTA。该盒内的凝固样本可包含柠檬酸盐。该盒内的化学部分可以包括本领域已知的凝块激活表面，以促进外源性凝块或内源性凝块或者外源性凝块和内源性凝块级联激活。
图5提供的流程图表明了本发明实施例的操作方式。例如，在步骤510中，在患者的体液与端口之间建立流体连通。在步骤520中，将患者的体液通过盒的一端引入到该盒内。在步骤530中，该盒与分析器(和/或分装器)连接。最后，在步骤540中，对来自盒的样本进行选自血液学、临床化学、免疫化学以及凝固分析的组的样本分析。
已经参考优选实施方式对本发明进行了描述。本领域技术人员容易理解，在不脱离本发明的真实范围和精神的情况下，能够对这些实施方式进行改变、变更或修改。

Claims (6)

1.一种用于接入生物流体以进行分析检测的系统，该系统包括：
盒，该盒包括进入端口、多个抽取端口和用于每个抽取端口的内部腔室，其中，所述内部腔室能够与每个抽取端口建立流体连通；和
分析器，用于接收所述盒，该分析器还包括至少一个抽取探针，用于从所述抽取端口中的每一个抽取生物流体。
2.如权利要求1所述的系统，其中，所述分析器对所述内部腔室中的至少两个执行至少两种不同的分析检测。
3.如权利要求2所述的系统，其中，所述分析检测选自由凝固、血液学、免疫化学和临床化学检测构成的组。
4.一种用于分装生物流体的方法，该方法包括以下步骤：
接收一盒，该盒包括多个内部腔室，该腔室的容积和表面专用于至少两种类型的样本，其中所述样本选自由凝固、血液学、免疫化学和临床化学分析样本构成的组；和
从所述腔室中的至少两个，将临时驻留在每个腔室中的至少一部分生物流体分装到每个腔室的至少一个唯一的分装试管中。
5.如权利要求4所述的方法，其中，在所述盒上存在标识，其中在分装之前通过扫描元件查询所述标识。
6.如权利要求5所述的方法，其中，所述标识为一维或二维的条形码。
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