CN104107059B - 生物流体收集装置和生物流体分离和测试系统 - Google Patents

生物流体收集装置和生物流体分离和测试系统 Download PDF

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Publication number
CN104107059B
CN104107059B CN201410151593.1A CN201410151593A CN104107059B CN 104107059 B CN104107059 B CN 104107059B CN 201410151593 A CN201410151593 A CN 201410151593A CN 104107059 B CN104107059 B CN 104107059B
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blood
chamber
blood sample
main body
collection device
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CN104107059A (zh
Inventor
C·A·盖尔芬德
A·R·罗滕伯格
B·M·威尔金森
D·J·马尔基鲁罗
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Becton Dickinson and Co
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Becton Dickinson and Co
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Priority to CN201610901616.5A priority Critical patent/CN106264565B/zh
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Abstract

本发明公开了一种生物流体收集装置,其适于接纳血液样品,血液样品具有细胞部分和血浆部分。在收集了血液样品之后,生物流体收集装置能将血液样品转移到护理点测试装置或生物流体分离和测试装置。在转移了血液样品之后,生物流体分离和测试装置能分离血浆部分与细胞部分并且分析血液样品并得到测试结果。

Description

生物流体收集装置和生物流体分离和测试系统
技术领域
总体而言,本公开涉及适于结合血管进入装置使用的装置、组件和系统。更具体地说,本公开涉及适于收集生物样品以用于护理点测试的装置、组件和系统。
背景技术
血液取样是常见的健康护理程序,其涉及从患者抽出至少一滴血液。血液样品通常通过手指针刺、足跟针刺或静脉穿刺从住院、家庭护理和急诊室患者取得。血液样品也可通过静脉或动脉管线从患者取得。在收集之后,可以分析血液样品以获得医疗上有用的信息,包括例如化学组成、血象指标(hematology)或凝固。
血液测试确定患者的生理和生物化学状态,诸如疾病、矿物质含量、药物效果和器官功能。可以在临床实验室或患者附近的护理点来执行血液测试。护理点血液测试的一个示例是患者血糖水平的常规测试,其涉及经由手指针刺提取血液并且将血液机械地收集到诊断盒内。之后,诊断盒分析血液样品并且向临床医生提供患者血糖水平的读数。可以利用另一些装置,这些装置分析血气电解质水平、锂水平和离子钙水平。一些其它护理点装置识别急性冠脉综合症(ACS)和深静脉血栓形成/肺栓塞(DVT/PE)的标记物。
尽管在护理点测试和诊断方面取得了快速的进步,血液取样技术保持相对不变。常常使用皮下针或者附连到针或导管组件近端的真空管来抽吸血液样品。在一些情形下,临床医生使用针和注射器从导管组件收集血液,针和注射器插入于导管内以通过插入的导管从患者抽取血液。这些程序利用针和真空管作为中间装置,通常在测试之前,从中间装置抽取所收集的血液样品。因此,这些过程是装置密集型的,在取得、制备和测试血液样品的过程中利用多个装置。每个额外的装置都增加了测试过程的时间和成本。
护理点测试装置允许测试血液样品而无需将血液样品发送到实验室用于分析。因此,希望发明一种装置,其向护理点测试系统提供容易、安全、可再现并且准确的过程。
发明内容
本公开提供一种生物流体收集装置,诸如血液收集装置,其适于接纳血液样品,血液样品具有细胞部分和血浆部分。在收集了血液样品之后,生物流体收集装置能将血液样品转移到护理点测试装置或生物流体分离和测试装置,诸如血液分离和测试装置。在转移了血液样品之后,生物流体分离和测试装置能分离血浆部分与细胞部分并且分析血液样品并获得测试结果。在一实施例中,生物流体收集装置提供一种封闭系统,其减少了血液样品向皮肤和环境的暴露并且提供血液样品与样品稳定剂的快速混合。样品稳定剂可以是抗凝剂或者被设计成在血液内保持特定元素(诸如RNA、蛋白质分析物或另一些元素)的物质。
根据本发明的一个实施例,一种生物流体收集装置包括刺血针外壳,其具有:入口端口;以及,内部,其限定与入口端口流体连通的第一流动通道。该装置还包括与第一流动通道流体连通的第二流动通道,并且第二流动通道的至少一部分从第一流动通道分流。该装置还包括穿刺元件,穿刺元件可在促动前位置与穿刺位置之间移动,在促动前位置,穿刺元件被固持在内部,在穿刺位置,穿刺元件延伸穿过外壳的入口端口并且提供与第一流动通道的流体连通。该装置还包括转移盒,转移盒具有储腔,并且第二流动通道与转移盒的储腔流体连通。
在一些配置中,第一流动通道适于在其中接纳血液样品。第一流动通道的尺寸可以设定为用于接纳提供给流动通道的第一血液。第一流动通道可包括与入口端口间隔开的储腔区域和与储腔区域间隔开的截头区域,第二流动通道可被设置为与截头区域流体连通。转移盒可与外壳的一部分可移除地接合。储腔的内部填充体积可对应于执行诊断测试所需的流体体积。第一流动通道和第二流动通道中的至少一者包括通往大气的通风口。
根据本发明的另一实施例,一种生物流体分离装置包括可旋转的主体,其具有旋转中心和外周。可旋转的主体具有适于接纳多组分血液样品的主体入口。该装置还包括分离腔室,分离腔室限定于可旋转的主体内并且与主体入口流体连通。分离腔室具有与主体入口间隔开的腔室出口,并且分离腔室适于接纳多组分血液样品。该装置还包括血液组分腔室,血液组分腔室限定于可旋转的主体内并且与腔室出口流体连通。当旋转力施加到可旋转的主体上时,多组分血液样品的一组分从分离腔室传递到血液组分腔室内,并且多组分血液样品的第二组分保持在分离腔室内。血液组分腔室设置为与旋转中心相邻,并且分离腔室设置为与可旋转的主体的外周相邻。
在一些配置中,血液组分为多组分血液样品的血浆组分,并且第二组分为多组分血液样品的细胞组分。该装置还可包括与血液组分腔室流体连通的诊断腔室。可旋转的主体可以是圆盘形。在另一些配置中,在由加工设备转动该可旋转的主体时,血液组分腔室接纳多组分血液样品的血液组分。该装置还可包括与血液组分腔室流体连通的诊断腔室和可由加工设备读取的检测区。
根据本发明的另一实施例,一种生物流体分离和测试系统,诸如用于多组分血液样品的血液分离和测试系统,包括生物流体收集装置。生物流体收集装置包括刺血针外壳,刺血针外壳具有:入口端口;以及,内部,其限定与入口端口流体连通的第一流动通道。该装置还包括与第一流动通道流体连通的第二流动通道,并且第二流动通道的至少一部分从第一流动通道分流。该装置还包括穿刺元件,穿刺元件可在促动前位置与穿刺位置之间移动,在促动前位置,穿刺元件被固持在内部,在穿刺位置,穿刺元件延伸穿过外壳的入口端口并且提供与第一流动通道的流体连通。该装置还包括转移盒,转移盒具有储腔,其中第二流动通道与转移盒的储腔流体连通。该系统还包括生物流体分离装置,诸如血液分离装置,其包括可旋转的主体,可旋转的主体具有旋转中心和外周。可旋转的主体具有适于接纳多组分血液样品的主体入口。该分离装置还包括分离腔室,分离腔室限定于可旋转的主体内并且与主体入口流体连通。分离腔室也具有与主体入口间隔开的腔室出口,并且分离腔室适于在其中接纳多组分血液样品。该分离装置还包括血液组分腔室,其限定于可旋转的主体内并且与腔室出口流体连通。当旋转力施加到可旋转的主体上时,多组分血液样品的一组分从分离腔室传递到血液组分腔室内,并且多组分血液样品的第二组分保持在分离腔室内。血液组分腔室设置为与旋转中心相邻,并且分离腔室设置为与可旋转的主体的外周相邻,并且主体入口能够与转移盒的储腔接合。
在一些配置中,可旋转的主体的一部分能够与转移盒的一部分以螺纹方式接合来对准主体入口与储腔流体连通。第一流动通道的尺寸可以设定为用于接纳提供给流动通道的第一血液。转移盒可以与外壳的一部分可移除地接合,并且随后可以与可旋转的主体的一部分接合。
在另一些配置中,第一流动通道和第二流动通道中的至少一者包括通往大气的通风口。该系统还可包括与血液组分腔室流体连通的诊断腔室。在一些配置中,血液组分为多组分血液样品的血浆组分,并且第二组分为多组分血液样品的细胞组分。在由加工设备转动该可旋转的主体时,血液组分腔室可接纳多组分血液样品的组分。该系统还可包括与血液组分流体连通的诊断腔室,并且包括能够由加工设备读取的检测区。
附图说明
结合附图考虑,通过参考本公开的实施例的下文的描述,本公开的上文提到的和另一些的特征和优点以及实现它们的方式将变得更加显然并且本发明的公开将被更好地理解,在附图中:
图1为根据本发明的一实施例的生物流体收集装置的立体图。
图2为根据本发明的一实施例的生物流体收集装置的组装立体图,其中转移盒接纳于刺血针外壳的一部分内。
图3为根据本发明的一实施例的生物流体收集装置的一部分的截面图。
图4为根据本发明的一实施例的生物流体收集装置的立体图,其中刺血针外壳处于第一位置。
图5为根据本发明的一实施例的刺血针外壳的截面图。
图6为根据本发明的一实施例的生物流体收集装置的立体图,其中刺血针外壳处于第二位置。
图7为根据本发明的一实施例的转移盒和生物流体分离和测试装置的立体图。
图8为根据本发明的一实施例的生物流体分离和测试装置的正视图。
图9为根据本发明的一实施例的加工和分析设备的立体图。
图10为根据本发明的一个实施例的转移盒的阀的截面图,其中阀处于闭合位置。
图11为根据本发明的一个实施例的转移盒的阀的截面图,其中阀处于打开位置。
在所有若干附图中,相对应的附图标记指示相对应的部件。本文所叙述的范例说明了本公开的示例性实施例,并且这样的范例不应被理解为以任何方式限制本公开的范围。
具体实施方式
提供以下描述以使得本领域技术人员能做出和使用所描述的实施例,所描述的实施例被设想用来执行本发明。但各种修改、等效物、变型和替代对于本领域技术人员显而易见。任何和所有这样的修改、变型、等效物和替代物意在属于本发明的精神和范围内。
在下文中,出于描述目的,术语“上”、“下”、“右”、“左”、“竖直”、“水平”、“顶部”、“底部”、“侧向”、“纵向”和其衍生词应在本发明处于附图中的方位时与本发明相关。然而,应了解本发明可以采取替代变型和步骤顺序,除非具体地规定为相反情况。应了解在附图中示出和在下文的说明书中所描述的具体装置和过程只是本发明的示例性实施例。因此,与本文所公开的实施例有关的具体尺寸和其它物理特征不应认为具有限制意义。
各种护理点测试装置是本领域中已知的。这样的护理点测试装置包括测试条、载玻片、诊断盒或者用于测试和分析的另一些测试装置。测试条、载玻片和诊断盒为护理点测试装置,其接纳血液样品并且测试血液的一种或更多种生理或生物化学状态。存在许多护理点装置,其在床边使用基于盒的架构分析很少量的血液而无需将样品发送到实验室进行分析。从长远来看,这节省了取得结果的时间,但与高度常规的实验室环境相比,带来了不同的系列挑战。这样的测试盒的示例包括购自Abbot group of companies的测试盒。测试盒,诸如测试盒,可以用来测试多种条件,包括化学品和电解质的存在、血象指标、血气浓度、凝固或心脏标记物。使用这些盒的测试结果被快速地提供给临床医生。
然而,提供给这些护理点测试盒的样品目前利用开放系统手动收集并且以手动方式转移到护理点测试盒,这常常造成不一致的结果,从而失去护理点测试装置的优点。因此,需要一种收集样品和将样品转移到护理点测试装置的系统,这种系统提供更安全、可再现并且更准确的结果。因此,将在下文中描述本公开的护理点收集和转移系统。本公开的系统由于以下原因而提高了护理点测试装置的可靠性:1)合并了更封闭类型的取样和转移系统;2)使样品的开放暴露最小化;3)改进了样品品质;以及,4)改进了总体易用性。
图1至图9示出了本公开的示例性实施例。参考图1至图9,生物流体收集装置,诸如本公开的血液收集装置10,适于接纳多组分血液样品12,多组分血液样品12具有细胞部分14和血浆部分16。
图7示出了本公开的示例性实施例。参考图7,本公开的生物流体分离和测试系统,诸如血液收集和测试系统20,包括血液收集装置10和可与血液收集装置10接合的生物流体分离和测试装置,诸如血液分离和测试装置,或者护理点测试装置22,以将血液样品12从血液收集装置10封闭地转移到血液分离和测试装置22。在转移了血液样品12之后,血液分离和测试装置22能分离多组分血液样品的血浆部分16与细胞部分14并且分析血液样品并获得测试结果。
参考图1至图6,血液收集装置10包括刺血针外壳26和转移盒28,转移盒28与刺血针外壳26的一部分可移除地接合。刺血针外壳26大体上包括顶部30、底部31、中心孔口或内部32、入口端口34、第一流动通道36、第二流动通道38、储腔区域40、截头区域42、穿刺元件接合部44、在刺血针外壳26的底部31上的粘合剂46和转移盒接纳腔体48。入口端口34和第一流动通道36适于在其中接纳血液样品。
在一实施例中,刺血针外壳26包括拉出第一滴血的分流和通风腔室或储腔区域40。在一实施例中,储腔区域40包括通风口或通风孔。在另一实施例中,储腔区域40可以容纳小海绵或芯吸材料,其能辅助抽吸第一滴血。在又一实施例中,储腔区域40可以包括被动阀设计。例如,储腔区域40可包括下面这样的结构:该结构首先填充储腔区域40并且仅在充分填充了储腔区域40之后,屏障,诸如毛细管中断部(capillary break),将被克服,从而允许血液样品流到转移盒28。在另一些实施例中,血液收集装置10可以包括适于将第一滴血拉到储腔区域40内而不使第一滴血流入到转移盒28的任何机构。
在一实施例中,刺血针外壳26包括与入口端口34流体连通的第一流动通道36,并且第二流动通道38与第一流动通道36流体连通。在一实施例中,第二流动通道38的至少一部分从第一流动通道36分流。在一实施例中,第一流动通道36和第二流动通道38中的至少一者包括通往大气的通风口。
现参看图3,在一实施例中,刺血针外壳26的第一流动通道36包括与入口端口34间隔开的储腔区域40和与储腔区域40间隔开的截头区域42。在一实施例中,刺血针外壳26的第二流动通道38被设置成与截头区域42流体连通。
参考图1至图6,血液收集装置10还包括穿刺元件结构70,穿刺元件结构70可以固连于刺血针外壳26的中心孔口或内部32内。穿刺元件结构70大体上包括第一端72、第二端74、与第一端72相邻的按钮76、与第二端74相邻的穿刺元件78,以及外壳接合部80。外壳接合部80接合刺血针外壳26的穿刺元件接合部44,用来将穿刺元件结构72固连到刺血针外壳26的中心孔口32内,如图5所示。穿刺元件结构70包括具有穿刺端82的穿刺元件78。穿刺端12适于穿刺患者的皮肤表面S(图4)并且可以限定尖端、刀片刃或类似切割机构。穿刺端112可包括优选对准方位,诸如刀片的尖端对准于具体方位。在一实施例中,穿刺元件78包括微针阵列。
穿刺元件78适于在促动前位置与穿刺位置之间移动,在促动前位置,包括穿刺端82的穿刺元件78固持于刺血针外壳26的内部32,在穿刺位置,穿刺元件78的穿刺端82延伸穿过刺血针外壳26的入口端口34以穿刺患者的皮肤表面S来抽吸血液样品12。在一实施例中,按钮76的促动将穿刺元件78从促动前位置移动到穿刺位置。
在一实施例中,血液收集装置10的刺血针外壳26可以包括自密封对接位,自密封对接位将允许外部刺血针或穿刺元件可移除地接纳于刺血针外壳26内。外部刺血针或穿刺元件可以预先整合到封装血液收集装置10内或者在使用本公开的血液收集装置10之前由使用者单独引入。
参考图1至图4,刺血针外壳26的底部31包括粘合剂或粘合剂层46,使得血液收集装置10可以固连到患者的皮肤表面S上,将在皮肤表面S取得血液样品。在一实施例中,由类似于粘合剂绷带的剥离层来保护底部31的粘合剂46,在将血液收集装置10放置于患者身体的皮肤表面S上之前移除粘合剂绷带。可以包括水凝胶或其它层以向下部31提供一些厚度并且帮助改进粘合剂密封的稳定性。此外,在一实施例中,粘合剂46可包括用来形成更不透水的密封的化学品,类似于画家胶带技术,其中,自颜料本身的湿润造成与粘合剂46起化学反应以防止颜料在胶带下方渗出。重要的是,粘合剂提供刺血针外壳26到患者的皮肤表面S的适当粘附并且最小化皮肤接触,这导致更好的样品用于凝固测试。刺血针外壳26的粘合剂46可以被穿刺元件78穿刺,使得从下面的伤口引出的血液通过切口到刺血针外壳26内,以在血液收集装置10内收集。
参考图1至图11,转移盒28包括第一壁部50、第二壁部52、转移端口54、储腔68和在转移端口54处的阀或隔膜86。在一实施例中,转移盒28的储腔68的内部填充体积对应于执行诊断测试所需的流体体积。
转移盒28的转移端口54可包括阀或隔膜86,阀或隔膜86可以在闭合位置与打开位置之间转变。在阀86处于打开位置的情况下,血液样品12可以通过转移盒28的储腔68流到血液分离和测试装置22,如在下文中更详细地描述的那样。
参考图2,转移盒28的一部分可以接纳于刺血针外壳26的转移盒接纳腔体48内。在此初始位置,刺血针外壳26的第二流动通道38与转移盒28的储腔68流体连通,使得所收集的血液样品12可以通过刺血针外壳26的入口端口34流到转移盒28的储腔68。当转移盒28的储腔68填充有血液样品12时,临床医生或患者可以将转移盒28从刺血针外壳26移除,如图1所示。当移除时,转移盒28的储腔68和刺血针外壳26的所有流动通道被密封,从而与外部环境隔离。
在一实施例中,在转移盒28接纳于刺血针外壳26的转移盒接纳腔体48内的情况下,第一壁部50接纳于转移盒接纳腔体48内并且转移盒28的第二壁部52从转移盒接纳腔体48向外延伸。以此方式,转移盒28的第二壁部52可以由使用者抓握以从刺血针外壳26移除该转移盒28。
血液收集装置10也可包括样品稳定剂层。举例而言,在一实施例中,在血液收集装置10内收集的血液样品12可以向刺血针外壳26或转移盒28的一部分中的样品稳定剂暴露并且与样品稳定剂混合。样品稳定剂可以是抗凝剂或者被设计成在血液内保持特定元素(诸如RNA、蛋白质分析物或另一些元素)的物质。在一实施例中,样品稳定剂可以设置于刺血针外壳26的一部分。在另一实施例中,样品稳定剂可以设置于转移盒28的一部分中或者血液收集装置10的任何其它区域中(在此区域中,其接触血液样品)。
参考图7和图8,血液分离和测试装置或护理点测试装置22包括:可旋转的主体100,可旋转的主体100具有旋转中心102和外周104;主体入口或接纳端口106;分离腔室108;流动通道110;血液组分腔室,诸如血浆腔室112;以及,与血浆腔室112流体连通的诊断部或诊断腔室114。在一实施例中,诊断腔室包括检测区116,检测区116可由加工和分析设备200读取(图9)。在一实施例中,可旋转的主体100是圆盘形。
接纳端口或主体入口106适于接纳转移盒28的转移端口54的阀86。血液分离和测试装置22适于接纳转移盒28的转移端口54的阀86,用来将血液样品12的一部分从转移盒28的储腔68封闭地转移到血液分离和测试装置22。血液分离和测试装置22能分离血浆部分16与细胞部分14并且分析血液样品12并获得测试结果。
分离腔室108限定于可旋转的主体100内,并且与主体入口106流体连通,并且分离腔室108包括与主体入口106间隔开的腔室出口或流动通道110。分离腔室108适于在其中接纳细胞部分14和血浆部分16。
血液组分腔室,诸如血浆腔室112,限定于可旋转的主体100内并且经由流动通道或腔室出口110与分离腔室108流体连通。当旋转力施加到可旋转的主体100上时,血浆部分16从分离腔室108传递到血浆腔室112内,并且细胞部分14保持在分离腔室108内。在一实施例中,在由加工和分析设备200旋转该可旋转的主体100时,血浆腔室112接纳血液样品12的血浆部分16。在一实施例中,血液腔室112被设置为与旋转中心102相邻,并且分离腔室被设置为与可旋转的主体100的外周104相邻。
在血液样品12接纳于血液分离和测试腔室22内后,血液分离和测试装置22可以插入于加工和分析设备200内,加工和分析设备200对血液样品12进行加工和分析。首先,血液分离和测试装置22以高速率自旋并且在分离腔室108中血浆部分16与细胞部分14分离。然后,减缓速度以将血浆部分16驱动到血液分离和测试装置22的中央部分中的血浆腔室112。然后可以通过血液分离和测试装置22的诊断部114在线加工血浆部分16。因为血液分离和测试装置22可以具有紧凑的圆盘格式,检测区116由加工和分析设备200的内部激光器在其仍自旋或运行时读取。
参考图7,血液分离和测试装置22包括适于接纳转移盒28的转移端口54的接纳端口或主体入口106。血液分离和测试装置22适于接纳转移盒28的转移端口54,用来将血液样品12的一部分从转移盒28的储腔68封闭地转移到血液分离和测试装置22。血液分离和测试装置22能分离血浆部分16与细胞部分14,并且分析血液样品12并获得测试结果。
如上文所论述的那样,转移盒28的转移端口54可包括阀或隔膜86,阀或隔膜86可以在闭合位置与打开位置之间转变。在阀或隔膜86处于打开位置(图11)的情况下,血液样品12可以通过转移端口54流到血液分离和测试装置22的主体入口106。
在一实施例中,参考图10和图11,阀86可通常包括转移通道90、波纹管或可变形的壁构件92和隔膜或屏障94,隔膜或屏障94具有第一屏障壁96和第二屏障壁98。参考图10,阀86处于闭合位置以防止血液样品12通过转移端口54流动。以此方式,血液样品12密封于转移盒28内。参考图11,阀86处于打开位置使得血液样品12可以通过转移端口54流动到血液分离和测试装置22。
参考图11,在血液样品12接纳于转移盒28的转移端口54内的情况下,然后将转移盒28的转移端口54定位于血液分离和测试装置22的接纳端口或主体入口106上。在箭头B方向向下推使可变形的壁构件92压缩并且打开隔膜94的第一屏障壁96和第二屏障壁98,如图11所示。在阀86处于打开位置的情况下,允许血液样品12以封闭方式通过转移端口54流到血液分离和测试装置22,减少了向临床医生和患者暴露。
仅当转移端口54压到血液分离和测试装置22的接纳端口106上时打开转移盒28的阀86。这将血液样品12直接释放到血液分离和测试装置22的接纳端口106内,从而减轻了向患者血液不必要的暴露。
在一实施例中,血液分离和测试装置22的可旋转的主体100的一部分能够与转移盒28的一部分以螺纹方式接合,以对准主体入口106使之与转移盒28的储腔68流体连通。
参考图1至图11,将描述本公开的血液收集装置的使用。参考图4,在选择位点后,临床医生可以将刺血针外壳26的下部31底表面上的粘合剂46粘附到患者皮肤表面S上,其中,在选定取样位点取得血液样品。
之后,按压或促动在血液收集装置10上的按钮76以使穿刺元件78从促动前位置移动到穿刺位置使得穿刺元件78穿刺患者的皮肤表面S。之后,参考图6,使血液收集装置10回转(rolled back)以经由刺血针外壳26的入口端口34将血液样品12收集到转移盒28的储腔68内。在一实施例中,血液样品12向刺血针外壳26或转移盒28的一部分中的样品稳定剂暴露并且与之混合。样品稳定剂可以是抗凝剂或者被设计成在血液内保持特定元素(诸如RNA、蛋白质分析物或另一些元素)的物质。
当已填充了转移盒28的储腔68时,临床医生或患者可以将转移盒28从刺血针外壳26移除,如图1所示。当移除时,转移盒28的储腔68和刺血针外壳26的所有流动通道被密封,从而与外部环境隔离。
参考图7,该过程的下一步涉及将转移盒28插入于血液分离和测试装置22内,以将血液样品从转移盒28转移到血液分离和测试装置22。在一实施例中,血液分离和测试装置22可以是紧凑圆盘分离和测试系统,其用作护理点测试装置。
参考图7和图11,转移盒28的转移端口54定位于血液分离和测试装置22的接纳端口或主体入口106上。在箭头B的方向向下推使可变形的壁构件92压缩并且打开隔膜94的第一屏障壁96和第二屏障壁98,如图11所示。在阀86处于打开位置的情况下,允许血液样品12以封闭方式通过转移端口54流到血液分离和测试装置22,减少向临床医生和患者的暴露。仅当将转移端口54压到血液分离和测试装置22的接纳端口106上时,打开转移盒28的阀86。这将血液样品12直接释放到血液分离和测试装置22的接纳端口106内,从而减少向患者血液不必要的暴露。
在血液样品12接纳于血液分离和测试装置22内后,血液分离和测试装置22可以插入于加工和分析设备200内,加工和分析设备200对血液样品12进行加工和分析。首先,血液分离和测试装置22以高速率自旋并且在分离腔室108中使血浆部分16与细胞部分14分离。然后,减缓速度以将血浆部分16驱动到血液分离和测试装置22的中央部分中的血浆腔室112。然后可以通过血液分离和测试装置22的诊断部114在线加工血浆部分16。因为血液分离和测试装置22可以具有紧凑的圆盘格式,检测区116由加工和分析设备200的内部激光器在其仍自旋或运行时读取。
虽然本公开被描述为具有示例性设计,但在本公开的精神和范围内,可以对本公开做出进一步修改。因此,本申请旨在涵盖使用本发明的一般原理的本公开的任何变型、使用或适应。另外,本申请旨在涵盖本公开所属技术中已知或惯例的并且属于所附权利要求限制内的与本公开的此类偏离。

Claims (16)

1.一种生物流体收集装置,包括:
刺血针外壳,其具有:入口端口;以及,内部,其限定与所述入口端口流体连通的第一流动通道和与所述第一流动通道流体连通的第二流动通道,其中,所述第二流动通道的至少一部分从所述第一流动通道分流;
穿刺元件,其能够在促动前位置与穿刺位置之间移动,在所述促动前位置,所述穿刺元件被固持在所述外壳内部,在所述穿刺位置,所述穿刺元件延伸穿过所述外壳的入口端口并且提供与所述第一流动通道的流体连通;以及
转移盒,其具有储腔,其中,所述第二流动通道与所述转移盒的所述储腔流体连通。
2.根据权利要求1所述的生物流体收集装置,其中,所述第一流动通道适于在其中接纳血液样品。
3.根据权利要求2所述的生物流体收集装置,其中,所述第一流动通道的尺寸设定为用于接纳提供给所述第一流动通道的第一血液。
4.根据权利要求1所述的生物流体收集装置,其中,所述第一流动通道包括与所述入口端口间隔开的储腔区域和与所述储腔区域间隔开的截头区域,其中,所述第二流动通道被设置为与所述截头区域流体连通。
5.根据权利要求1所述的生物流体收集装置,其中,所述转移盒能够与所述外壳的一部分可移除地接合。
6.根据权利要求1所述的生物流体收集装置,其中,所述储腔的内部填充体积对应于执行诊断测试所需的流体体积。
7.根据权利要求1所述的生物流体收集装置,其中,所述第一流动通道和第二流动通道中的至少一者包括通往大气的通风口。
8.一种用于多组分血液样品的生物流体分离和测试系统,包括:
生物流体收集装置,其包括:
刺血针外壳,其具有:入口端口;以及,内部,其限定与所述入口端口流体连通的第一流动通道和与所述第一流动通道流体连通的第二流动通道,其中,所述第二流动通道的至少一部分从所述第一流动通道分流;
穿刺元件,其能够在促动前位置与穿刺位置之间移动,在所述促动前位置,所述穿刺元件被固持在所述外壳内部,在所述穿刺位置,所述穿刺元件延伸穿过所述外壳的入口端口并且提供与所述第一流动通道的流体连通;以及
转移盒,其具有储腔,其中,所述第二流动通道与所述转移盒的所述储腔流体连通;以及
生物流体分离装置,其包括:
可旋转的主体,其具有旋转中心和外周,所述可旋转的主体具有适于接纳所述多组分血液样品的主体入口;
分离腔室,其限定于所述可旋转的主体内并且与所述主体入口流体连通并且具有与所述主体间隔开的腔室出口,所述分离腔室适于在其中接纳所述多组分血液样品;以及
血液组分腔室,其限定于所述可旋转的主体内并且与所述分离腔室的所述腔室出口流体连通,其中,当旋转力施加到所述可旋转的主体上时,所述多组分血液样品的血液组分从所述分离腔室传递到所述血液组分腔室内,并且所述多组分血液样品的第二组分固持于所述分离腔室内,
其中,所述血液组分腔室设置为与所述旋转中心相邻,并且所述分离腔室设置为与所述可旋转的主体的外周相邻,并且
其中,所述主体入口能够与所述转移盒的所述储腔接合。
9.根据权利要求8所述的生物流体分离和测试系统,其中,所述可旋转的主体的一部分能够与所述转移盒的一部分以螺纹方式接合来对准所述主体入口与所述储腔流体连通。
10.根据权利要求8所述的生物流体分离和测试系统,其中,所述第一流动通道的尺寸设定为用于接纳提供给所述第一流动通道的第一血液。
11.根据权利要求8所述的生物流体分离和测试系统,其中,所述转移盒能够与所述外壳的一部分可移除地接合并且随后能够与所述可旋转的主体的一部分接合。
12.根据权利要求8所述的生物流体分离和测试系统,其中,所述第一流动通道和第二流动通道中的至少一者包括通往大气的通风口。
13.根据权利要求8所述的生物流体分离和测试系统,还包括与所述血液组分腔室流体连通的诊断腔室。
14.根据权利要求8所述的生物流体分离和测试系统,其中,所述血液组分为多组分血液样品的血浆组分,并且所述第二组分为所述多组分血液样品的细胞组分。
15.根据权利要求8所述的生物流体分离和测试系统,其中,在由加工设备转动所述可旋转的主体时,所述血液组分腔室接纳所述多组分血液样品的所述血液组分。
16.根据权利要求8所述的生物流体分离和测试系统,还包括与所述血液组分流体连通的诊断腔室,并且包括能够由加工设备读取的检测区。
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