CN1262236C - 间质流体及全血样品的采样装置 - Google Patents
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Abstract
本发明涉及一种流体采样装置,该装置包括一本体,该本体包括一具有透刺端及连通端的表皮层透刺探头,以及一具有近端及远端的分析室,该分析室具有一容积,其中所述分析室包括一电化学单元,该单元包括一工作电极和一反电极/参考电极,所述采样装置还包括一前置室,该前置室具有一容积和一第一端及第二端,其中该前置室布置在透刺探头和分析室之间,使得前置室的第一端靠近透刺探头的连通端,而前置室的第二端靠近分析室的近端,其中前置室的容积大于或等于分析室的容积,其中该透刺探头与该分析室流体连通,使得流体可以从透刺探头向分析室流动。该装置适用于流体中实际存在的具有典型浓度的任何分析物,特别适用于葡萄糖监视。
Description
技术领域
本发明涉及一种装置,用于将间质流体或全血样品的采样及分析功能组合起来,该装置适于在医院的病床侧和家庭中使用。
背景技术
在许多疾病的治疗中都要求对体液中的许多分析物进行测量和监视。在过去,为了对血液中的分析物进行测量就要采用侵入性技术,诸如通过静脉或刺破手指来获得血液以进行采样。按照常规方法,需要通过侵入性技术获得血液样品来进行测试的分析物的一个典型例子是葡萄糖。糖尿病患者为了控制其疾病必须定期进行葡萄糖水平监视。使用侵入性技术获得血液样品来进行分析具有令人痛苦的缺点,这会降低病人对定期监视的顺从性。反复地在例如手指尖上进行测试还会使疤痕组织积累起来,从而导致在该区域中的取样工作更加困难。另外,侵入性取样过程还有感染或传播疾病的危险。
一个替代方案是采集间质流体而不是采集全血液。间质流体是充填在皮肤表层相连组织和细胞之间的空间中的流体。在葡萄糖浓度的测量中,间质流体的应用已经显示出是血浆和全血样品的合适采样代用品(J.Lab.Clin.Med.1997,130,436.41)。
在美国专利US 5,879,367;US 5,879,310;US 5,820,570及US 5,582,184中公开了采集少量间质流体以便进行葡萄糖监视的方法,该方法用一个精细的针头与一个装置相连以限制透刺的深度。然而,没有公开适于家庭或医院床侧使用的对所抽取的样品进行分析的方法。
发明内容
希望能测量人或其他动物的分析物浓度,而无须使用常规方法抽取血液样品。还希望能够利用价格低廉的一次性使用装置进行上述操作,该装置足够简便,适于家庭或医院床侧使用。
本发明提供了一种流体采样装置,该装置包括一本体,该本体包括一具有透刺端及连通端的表皮层透刺探头,以及一具有近端及远端的分析室,该分析室具有一容积,其中所述分析室包括一电化学单元,该单元包括一工作电极和一反电极/参考电极,所述采样装置还包括一前置室,该前置室具有一容积和一第一端及第二端,其中该前置室布置在透刺探头和分析室之间,使得前置室的第一端靠近透刺探头的连通端,而前置室的第二端靠近分析室的近端,其中前置室的容积大于或等于分析室的容积,其中该透刺探头与该分析室流体连通,使得流体可以从透刺探头向分析室流动。
本发明的装置比传统的全血取样技术呈现更小的侵入性,并且所需的样品体积明显少于常规的静脉抽取或手指透刺采样方法所需的样品体积。由于只要采集较小的样品体积,因此获得样品所需的伤口也较小。在常规的手指戳刺方法中,要在指尖上形成一滴血,然后再用这滴血沾湿传感器的样品入口。由于样品要和皮肤表面接触,样品便可能被皮肤表面上的材料污染。本文公开的装置和方法不需要在皮肤表面上形成血滴,因此样品污染的危险较小。
在本发明的一个实施例中,提供了一种流体采样装置,该装置包括一本体,该本体包括一表皮层透刺探头及一分析室。该探头具有一透刺端和一连通端。该分析室具有一近端及一远端。分析室具有一容积,其中透刺探头与该分析室流体连通,因此流体可以从透刺探头流向分析室。分析室可以具有至少一个柔性壁,可以对柔性壁加压来减少分析室的容积。透刺探头可以包括例如针、刺血针、管子、通道或坚固的突出部;并且可以由诸如碳纤维、硼纤维、塑料、金属、玻璃、陶瓷、复合材料、它们的混合物以及它们的组合物等材料构成。透刺探头可以包括两个大致对齐的材料板片,每个板片上有一突出部,这些板片是间隔开的,因此液体能够被毛细管作用吸取进入板片之间。这两个材料板片可以延伸到装置内部而形成一前置室。透刺探头可以定位于装置近端的一凹槽中,该凹槽可以构制成和选定的表皮表面的形状基本上对齐。
在下一个实施例中,该装置还包括一前置室,该前置室具有一容积和第一及第二端,其中该前置室位于透刺探头和分析室之间,使得前置室的第一端邻近透刺探头的连通端,前置室的第二端则邻近分析室的近端。前置室的容积可以大于或等于分析室的容积。前置室可以具有至少一个柔性壁,该柔性壁可以被压缩以减少前置室的容积。前置室还可以包括一位于其第一端处的阀门,该阀门能够将前置室与透刺探头基本密封住。
在另一个实施例中,该装置还包括一与分析室相连通的可压缩的囊状部件,该可压缩囊状部件能够对分析室施加一正压力或负压力。
在又一个实施例中,前置室和分析室能够施加不同的毛细管力。分析室施加的毛细管力可以大于前置室施加的毛细管力。毛细管力的差异可以至少部分地由前置室高度和分析室高度的差异所造成。在该实施例中,前置室的内部表面可以包括至少第一前置室壁及第二前置室壁,这两个壁的间距为第一距离以便确定前置室高度,并且分析室的内部表面可以包括至少第一分析室壁及第二分析室壁,这两个壁的间距为第二距离以便确定分析室高度。其中分析室高度小于前置室高度。
在又一个实施例中,这些室中的至少一个室可以包括能够增强或减弱由该室施加的毛细管力的物质。该物质可以包括例如聚合物、树脂、粉末、筛、纤维材料、晶体材料或多孔材料。适用的物质包括聚乙二醇、聚乙烯吡咯烷酮、表面活性剂、亲水性嵌段共聚物以及聚乙酸乙烯酯。
在下一个实施例中,该装置还包括一可释放的作动器,该作动器能够提供足够的力以使透刺探头穿透表皮层。该作动器可以在本体外部或与本体成一体,并且一旦释放就将本体推向表皮层。
在下一个实施例中,分析室可以包括一电化学单元,该电化学单元包括一工作电极和一反电极/参考电极以及一与测量仪表相连通的接口。其中该接口传送一电压或电流。
附图说明
图1为采样装置的一个实施例的顶视图(未按比例),图中展示了透刺探头、前置室和分析室的一种布置;
图2为沿着图1的线A-A′切割时的截面图(未按比例);
图3为采样装置的一个实施例的顶视图(未按比例),图中展示了透刺探头、前置室和分析室的一种布置,其中装置的近端形成了一个凹槽;
图4为采样装置的一个实施例的顶视图(未按比例),图中展示了透刺探头、前置室和分析室的布置;
图5为沿着图4的线B-B′切割时的截面图(未按比例);
图6a及图6b描述本发明的一个实施例(未按比例),其中装置被装在一个可释放的作动器中以便使透刺探头易于刺穿表皮层;图6a所示为装置装在作动器中,其中作动器处于抬起位置,准备触发;图6b所示为触发后的装置及作动器。
具体实施方式
介绍
在下面的描述和例证中,将对本发明的许多实施例进行详细说明。本专业的技术人员都会知道,在本发明的范围内还可以对本发明进行许多改变和修饰。因此,对优选实施例的描述不应该被认为是对本发明的范围的限定。和本专利申请同时申请并共同待审的题为“METHOD OF PREVENTING SHORT SAMPLING OF A CAPILLARY ORWICKING FILL DEVICE”的美国专利申请No.----/----对优化流体样品采样的装置及方法有更进一步的讨论,这里并入该项专利申请的全文作为参考。
本申请中公开的发明是一种方法及装置,用于将皮下组织中的流体样品的采样及分析工作组合在一个装置中,该装置适于在医院的病床侧和家庭中使用。该流体样品可以包括取自动物身体的间质流体或全血样品,但不限于此。任何动物或植物的皮下组织的流体样品都可以被采样并分析,因此本发明在人类医学、兽医、园艺科学等领域有广泛的用途。该装置及方法适用于流体样品中实际存在的具有有用的典型浓度的任何分析物。为了清楚起见,在本专利公开中将着重讨论其在葡萄糖监视中的应用。然而,应该理解,本发明不限于应用在葡萄糖监视中,而是如下面将要讨论那样也可用来测量其他分析物。
该方法使用一种整体的结合有透刺探头12的采样及分析装置10,该透刺探头12能够刺透病人的表皮层以抽取间质流体或全血样品。以及一种用来将样品从透刺探头12输送到分析室20的方法。在一个实施例中,装置可以是一种一次性使用的装置,该装置可以插入一个测量仪表,该仪表和分析室20相通以对样品和存在物进行分析并备选地将结果储存下来。
在装置10中,用来刺透患者的表皮层以采集间质流体或全血样品的透刺探头12和分析室20合并成一体。采集间质流体时的特性是,需要几秒到几十秒的时间来采集到足量的样品以进行分析。对分析室20经常不能符合要求,在分析室中,分析物要参加一种反应,该反应是分析过程的一部分,而这种分析测试的准确开始时间难以确定,并且样品中的反应试剂也难以达到均匀分布。因此本发明的第二方面中提供一种方法,该方法将样品采集在一个前置室14中,当前置室14充满时再将样品快速地传输到分析室20中。
在本发明公开中,除非其上下文中清楚说明有不同的意思,“近端”一词是指装置上的一个区域或构造,该区域或构造处于面对或邻近待刺透的表皮的位置上;而“远端”一词则指装置上的一个区域或构造,该区域或构造朝向装置的相对端(非近端)。例如,透刺探头12处于装置的近端。
透刺探头
透刺探头12可以是任何一种装置,该装置能够穿透患者表皮层到要求的程度,能够将样品传输到前置室14或分析室20中。透刺探头12包括如图1所示的两个端部。透刺探头12的透刺端11是其插入表皮层的一端。透刺探头12的连通端13是其连通到前置室14或分析室20的一端。
带有至少一个锐边或尖点的一个或多个突出部适于用作透刺探头12。可以用来制作透刺探头12的材料包括塑料、金属、玻璃、陶瓷、复合材料(例如陶瓷和金属颗粒的复合材料)或这些材料的混合物和组合物。透刺探头12的形式可以包括刚性突出部、针、刺血针、管子或通道。备选的是,该通道沿着其一个或多个细长侧边可以是敞开的。如图2所示,透刺探头12的一个优选实施例由两个材料板片30形成,以便每个板片30都有一个尖锐的突出部12,这些突出部12基本上对齐。板片30之间隔开,液体可以被毛细管作用吸取进入板片30之间。在一个特别优选的实施例中,两个材料板片30一直延伸并覆盖到分析室20上,从而形成了一个收集样品的前置室14。
当采集间质流体时,可以通过限制透刺探头12突出到采样装置10的近端表面34以外的长度使其小于表皮层厚度的办法来控制透刺深度。在一个优选实施例中,突出部的长度为小于2到3毫米,更优选为约1.5毫米。当刺透的合适深度对应于突出部12的长度后,采样装置的表面34和表皮层的表面之间相接触,从而阻止进一步深入。在用作诸如从具有厚表皮层的区域进行间质流体采集或兽医等其他用途时,突出部的长度可以要求大于3毫米。因此,本发明所考虑的突出部可以为任何长度,其中该长度足以采集间质流体。当用于采集全血时,应该使用的透刺探头12的长度稍大些,亦即要大于2到3毫米。
透刺探头12的直径或宽度取决于透刺探头12的构造,合适的直径或宽度应能保证足够的样品流。在突出部形成一个锐边或尖点、或一个管子或通道的情况下,其最小直径或宽度一般大于约10微米。在透刺装置包括两个基本对齐的板片30的情况下,每个板片具有一个尖锐突出部12,这两个突出部之间的间隔一般为从1毫米到10微米。
透刺探头12可以位于测试条带10上的任何合适部分上,亦即可位于边缘34、角42或其中的一个平坦表面44上。可以给透刺探头12设置一种保护装置,将其布置在测试条带10的远端边缘34上形成的一个凹槽内,如图3所示,或是将其布置在测试条带10的平坦表面44上的一个凹坑内。在一个优选实施例中,测试条带10的远端边缘34上的凹槽可以设计成与选定的表皮表面例如手指尖的形状基本上相对齐。然而该凹槽可以设计成其他的适用形状,例如,正方形凹槽、V字形凹槽、曲线形凹槽、多边形凹槽等等。在一个优选实施例中,透刺探头12不突出超过装置10的近端边缘34或表面44的最近部分,但当其压到皮肤上后,皮肤会变形进入凹槽而被透刺探头12刺透。由于对采样点周围的皮肤区域加压,因此这样的设计对样品的采集是有帮助的。透刺探头12可以如图2所示那样形成为测试条带10中的另一个部件的一个整体部分,例如前置室54的一个侧边。备选的是,透刺探头12可以包括分离零件,该分离零件可以用任何适用的手段附接或结合到测试条带10中。这些手段例如粘结剂、热粘合、互锁零件、压力等等。透刺探头12可以是可收缩的或是不可收缩的。
可以用任何合适的手段来完成刺透动作。这些手段包括用手工方法或用诸如图6a及图6b所示的弹簧加载机构84那样的可释放的作动器84来完成透刺装置12的插入。这种弹簧加载机构84中设有一个受到压缩并用一个触发器88保持就位的弹簧86,当触发机构致动时,触发器88可以将压缩弹簧86的力释放出来。触发器88的触发可以是手动的,或是装置84结合有压力传感器,该传感器指示出所加的压力已足以获得样品时便致动触发器88。在一个实施例中,装置10的远端放在弹簧加载机构84中,因此当弹簧86的压缩力由于触发器88的致动而释放时该力便传到装置10上,装置10便从机构84中射出并将透刺探头12插入表皮层中。
身体上的任何合适部位都可进行采样。在一个优选实施例中,其采样区域是神经末稍密度不高的区域,例如前臂上。通常需要5到15秒钟便可获得足够的样品。在抽取间质流体或全血时可以对采样区域加压。为了使所加的压力大小适当,可以在装置10中设置一个压力传感器。当所加的压力足够时该传感器便发出信号。对直接采样区域的周边区域施加较大的压力可以改善采样时间。某些因素对间质流体或全血样品采集可能有影响,这些因素包括患者的年龄、皮肤的厚度、温度及水合作用(hydration)。测试所需的间质流体或全血样品的量优选为约0.02微升或更多些,更优选为0.1微升或更多些,最优选的为约0.5微升或更多些。
在一个优选实施例中,装置10可以在进行样品采集之前插入到一个测量仪表中。在这样的实施例中,测量仪表施加了多种功能,这些功能包括支承装置10、提供启动样品采集的自动装置以及指示样品的采集何时完成。
样品从透刺探头向分析室的转移
在采样装置10的一个优选实施例中,装置包括两个部件:透刺探头12和分析室20。在另一个优选实施例中,装置10如图1及图2所示那样包括透刺探头12及一个前置室14。前置室14可以和分析室20制成一体或是和分析室20相连接。
在另一个实施例中,分析室20和一个装置制成一体或和该装置相连接,该装置的用途为使分析室20更易于充填。该装置可以包括一个可折叠或可压缩的囊状部件22,如图3及图4所示,可以用来给分析室20施加正的或负的压力(亦即部分真空)。可压缩囊状部件22可以包括任何具有柔性壁的腔室,该腔室可以被压缩而减少其容积。当加在该可压缩囊状部件22上的压缩力释放掉时,便形成部分真空,这就吸取样品进入分析室20。在一个优选实施例中,可压缩囊状部件22的容积足够的大,因此当囊状部件22基本上完全压缩时,囊状部件22容积的减少量大于或等于分析室20的总容积,所以能保证分析室20基本上充满。然而,一个容积小于分析室20的可压缩囊状部件22也可以有效地帮助分析室20的充填。
备选的是,分析室20本身是可折叠或可压缩的。在这样的实施例中,可以通过一个活塞或其他压缩手段首先压缩分析室20随后松开该分析室,从而形成部分真空,该其他压缩手段例如患者或临床医师的手指。当压缩力松开后,该部分真空便使样品从透刺探头朝分析室流动。
前置室
在一个优选实施例中,如图1及图2所示,集成式的采样和测试装置10中设有一个前置室14,其用途为在样品转移到分析室20之前积累并储存所采集的样品。当所采用的分析方法要求样品必须在短时间内充满分析室20才能返回精确结果时前置室14是很有用的,亦即,要求样品充满分析室20的时间短于从表皮层抽取足量样品的时间。在一个优选实施例中,前置室14的容积大于分析室20的容积,这样就能保证前置室14一旦充满,就采集足量的样品以便将分析室20完全充满。
在一个优选实施例中,如图1及2所示,透刺探头12在第一端通向前置室14,而在第二端前置室14则通向分析室20。前置室14中可以没有试剂或其他物质,或是可以备选地包含一种或多种物质,其用途是增强或减弱前置室14的壁所产生的毛细管力或是在样品进行分析之前先对其进行预处理。这些物质可以包括例如聚合物、树脂、粉末、筛、纤维材料、晶体材料、多孔材料、或它们的混合物或组合物。为了有助于分析室20的有效充填,一个优选实施例采用了如图2所示的前置室14及分析室20,这两个腔室的高度不相同,其中分析室20的高度(通常是指腔室的最小尺寸)小于前置室14的高度。这样就产生了一个毛细管力,该毛细管力能够将流体从前置室14中吸到分析室20中。在分析室20的端部70处可以形成一个第一气孔64,该孔64和通向前置室14的开口62相对。当样品进入分析室20时让被置换的空气从该分析室排出,从而有助于分析室20的充填。备选的是,可以在前置室14的基本相对的端部60上形成一个通向前置室14的第二气孔74,在该端部60处透刺探头12通向前置室14。该气孔74的用途为当样品从前置室14转移到分析室20时空气便可从该气孔74提供进入前置室14中以便替换样品。气孔74可以位于测试条带10上任何合适的位置上。在一个优选实施例中,气孔74包括一个例如90°的尖角,该尖角的用途为“毛细管作用止挡件”,以便阻止样品通过气孔74流出装置10。
在另一个实施例中,前置室14包括一个管子或其他形状的腔室,该管子或腔室和透刺探头12相连接,带有柔性壁。在该实施例中,前置室14或是永久性地固定在分析室20上或是紧接着分析室20的端口布置,并与该端口对准。在使用期间,当装置合适地放在一个诸如测量仪表等外部装置上时就可以出现这样的对准。在该实施例的一个方面,前置室14还包括一个阀门,其限定为控制透刺探头12及前置室14之间的流体样品的流动的装置。该阀门可以包括一个或多个滚子、活塞或挤压装置。该阀门能够同时将前置室14的第一端60关闭并对前置室14加压,从而迫使前置室14中的流体向前置室14的第二端62流动并随后流动进入分析室20。
备选的是,分析室20包括一个管子或其他形状的腔室,该管子或腔室和透刺探头12相连接,带有柔性壁。在该实施例的一个方面,在刺透之前用一个或多个滚子、活塞或其他挤压装置来压缩分析室20,在透刺探头12插入后,松开对分析室20的压缩以形成真空,该真空将样品拉入分析室20。在这样的实施例中,如果产生的真空度足以使样品采集迅速进行,那么前置室14可以不是必须的。在这种实施例中,如果气孔64、74对形成真空有干扰,那么装置10可以不设置气孔64、74。
在另一个如图3及图4所示的实施例中,形成有一个尺寸合适的前置室14。前置室14在一端60通向透刺探头12,在另一端62通向分析室20。分析室20的一端70通向一个可压缩囊状部件22,这一端70和通到前置室14的一端相对。囊状部件22可以是单独形成并且附接在分析室20的端部70上的。备选的是,这可以通过去除测试条带10中的中间层板82上的一个部分来形成,如图3和4所示,这和WO97/00441(其全文结合于此作为参考)所述的相似。
使用时,在透刺探头12插入患者身体之前先用合适装置压缩条带10中的囊状部件22。透刺探头12的插入可以用一个诸如压力传感器那样的传感器来确认,或可由患者通过视觉或触觉来确认透刺探头12的插入。在后者的情况下,患者的感觉可以通过诸如按动一个按钮来给测量仪表发信号。此时,可将囊状部件22的压缩装置撤回到一半的位置上以吸取样品进入前置室14。当前置室14充满后,如通过适用的传感器来指示,测量仪表便指示患者撤回透刺探头12。然后可将压缩装置运动到其全部撤回位置以将样品从前置室14吸取进入分析室20。如果囊状部件22的初始吸力使待积累的样品具有足够的速度,前置室14可以省去而用囊状部件22来直接吸取样品通过透刺探头12进入分析室20。在某些实施例中,气孔64、74可能会干扰真空的形成,因此装置中不需要包括这些气孔。
分析室
在一个优选实施例中,分析装置10包括一个和WO97/00441所述相似的一次性使用分析条带,该装置10包含有分析室20。WO97/00441所述的分析条带包含一个用来确定载体中分析物浓度例如流体样品中的葡萄糖浓度的生物传感器。该条带中的电化学分析单元20的有效容积为1.5微升或更少些。该电化学单元20可以包括一个多孔薄膜,薄膜的一侧有一个工作电极,另一个侧有一个反电极/参考电极。在一个优选实施例中,所使用的分析单元20的有效容积为约0.02微升或更大些。更优选的是,单元20的容积在约0.1微升到约0.5微升之间。
在该实施例的一个方面,透刺探头12是一个与分析条带10成为一体的小针头,该针头穿过分析室20的一个壁,因此该针头12的一端与条带分析室20的内部相通。为了获得间质流体样品并对这种样品进行分析,使用具有这种布置的装置10,其中针头插入患者的表皮层并通过毛细管作用将样品吸取进入针头,然后样品通过毛细管作用从针头传输进入分析室20并在那里进行样品分析。分析室20中设有一个通向大气的开口64,该开口64和针头通入该室的地点相距甚远,该通道64用作气孔64,以便当分析室20充入样品时使得被置换的空气可从这里排出。这种构造特别适用于WO97/00441所公开类型的分析装置,因为它们能够使用非常少量的样品,这样少量的样品一般是间质流体采样所能提供的。
分析室20可以包含一种或多种物质以增强或减弱分析室20的壁面所施加的毛细管力。这类物质可以包括上述前置室中同样使用的聚合物、树脂、粉末、筛、纤维材料、晶体材料、多孔材料或它们的混合物或组合物。作为例子,分析室20的壁面24可以覆盖一亲水性材料来促进流体样品流入分析室。适用的亲水性材料包括聚乙二醇、聚乙烯吡咯烷酮、表面活性剂、亲水性嵌段共聚物以及聚丙烯酸。分析室20还可以包含试剂,该试剂能够与样品中存在的分析物或其他物质起反应,该其他物质可以包括对确定分析物存在或不存在的过程有影响的物质。在这种情况下,试剂将和该种物质起反应致使其不再影响分析过程。
装置10可以用来分析流体样品中存在的可检测数量的任何分析物。典型的分析物可以包括离子、元素、糖、醇、激素、蛋白质、酶、辅因子、核酸序列、脂类和药物,但不限于此。在一个优选实施例中,葡萄糖是待测试的分析物。典型的分析物可以包括乙醇、钾离子、药剂、药物、胆固醇及乳酸,但不限于此。
可以直接地确定分析物存在或不存在。备选的是,可以通过分析物与存在于分析室中的一种或多种试剂所起的反应来确定分析物,为此要对指示分析物存在或不存在的反应产物进行检测。适用的反应产物包括颜色指示剂、电流、电位、酸、碱、沉淀物或气体。
任何适用的分析方法都可用来确定分析物或分析物的反应产物存在或不存在。适用的分析方法包括电化学方法、光吸收检测法、光发射检测法以及磁化率测量法,但不限于此。在反应产物与分析物具有不同颜色或形成沉淀物或气体的情况下,目测可以是合适的确定分析物存在或不存在的方法。
测量数据的显示/储存
在一个优选实施例中,如上所述的分析条带或采样装置10的另一个实施例与一个测量装置连为一体。该测量装置例如为一个能够显示、储存或记录测试数据的测量仪表,备选的是,该数据具有计算机可读的格式。在这种实施例中,测试条带10包括一个与该测量仪表相连通的接口,例如从电化学单元20的电极引出的导线。在要进行电化学测量的情况下,该接口将一个电压或电流连通到电化学单元20上。
以上描述了本发明公开的几种方法和材料。本专业的技术人员都易于在本发明公开所作的考虑和实践的范围之内对上述方法和材料及制造方法和设备作出改变或修改。应该指出,这里所公开的具体的实施例不意味着对发明范围的限制,而下面所附的权利要求书将函盖所有这些修改及改变。
Claims (22)
1.一种流体采样装置,该装置包括一本体,该本体包括一具有透刺端及连通端的表皮层透刺探头,以及一具有近端及远端的分析室,该分析室具有一容积,其中所述分析室包括一电化学单元,该单元包括一工作电极和一反电极/参考电极,所述采样装置还包括一前置室,该前置室具有一容积和一第一端及第二端,其中该前置室布置在透刺探头和分析室之间,使得前置室的第一端靠近透刺探头的连通端,而前置室的第二端靠近分析室的近端,其中前置室的容积大于或等于分析室的容积,其中该透刺探头与该分析室流体连通,使得流体可以从透刺探头向分析室流动。
2.如权利要求1所述的装置,其特征在于,分析室具有至少一个柔性壁,并且其中一旦在柔性壁处对该室进行压缩,该分析室的容积就会减少。
3.如权利要求1所述的装置,其特征在于,前置室具有至少一个柔性壁,并且其中一旦在柔性壁处对该室进行压缩,该前置室的容积就会减少。
4.如权利要求1所述的装置,其特征在于,前置室包括一阀门,该阀门位于第一端处,该阀门能够将前置室与透刺探头基本上密封。
5.如权利要求1所述的装置,其特征在于,前置室的内部表面包括至少第一及第二前置室壁,这两个壁之间的间隔距离为第一距离以便确定前置室的高度,并且其中分析室的内部表面包括至少第一及第二分析室壁,这两个壁之间的间隔距离为第二距离以便确定分析室的高度,其中分析室的高度小于前置室的高度,并且其中前置室高度和分析室高度之间的差异至少部分地导致产生了毛细管力差异,从而分析室施加的毛细管力大于前置室施加的毛细管力。
6.如权利要求1所述的装置,其特征在于,所述前置室和所述分析室中的至少一个包含有一种物质,该物质选自粉末、网状物、纤维材料、晶体材料、多孔材料。
7.如权利要求6所述的装置,其特征在于,该物质选自聚乙二醇、聚乙烯吡咯烷酮、表面活性剂、亲水性嵌段共聚物以及聚乙酸乙烯酯。
8.如权利要求2所述的装置,其特征在于,前置室包括一第一前置室壁及一第二前置室壁,而其中分析室包括一第一分析室壁及一第二分析室壁,以及其中前置室壁之间的距离大于分析室壁之间的距离。
9.如权利要求1所述的装置,其特征在于,该装置还包括一可压缩囊状部件,该囊状部件和分析室相连通,该可压缩囊状部件能够对分析室施加正压力或负压力。
10.如权利要求9所述的装置,其特征在于,可压缩囊状部件与分析室的远端相通。
11.如权利要求1所述的装置,其特征在于,透刺探头选自针头、刺血针、管子、通道和坚固的突出部。
12.如权利要求1所述的装置,其特征在于,透刺探头包括一材料,该材料选自碳纤维、硼纤维、塑料、金属、玻璃、陶瓷、复合材料、及其混合物。
13.如权利要求1所述的装置,其特征在于,透刺探头包括两个基本上对齐的材料板片,每个该板片上有一突出部,其中这些板片是间隔开的,使得液体可被毛细管作用吸入板片之间。
14.如权利要求13所述的装置,其特征在于,这两个材料板片延伸到该装置内以便形成所述前置室。
15.如权利要求1所述的装置,其特征在于,该装置具有一近端边缘,该边缘包括一凹槽,其中透刺探头定位于该凹槽内。
16.如权利要求15所述的装置,其特征在于,该凹槽构制成和选定表皮表面的形状基本对齐。
17.如权利要求1所述的装置,其特征在于,该装置还包括一可释放的作动器,其中该作动器能够提供一足以使透刺探头穿透表皮层的力。
18.如权利要求17所述的装置,其特征在于,该作动器在本体外部,并且其中一旦释放,该作动器就将本体推向表皮层。
19.如权利要求17所述的装置,其特征在于,该作动器和本体成一体。
20.如权利要求19所述的装置,其特征在于,一旦释放,该作动器就将透刺探头推向表皮层。
21.如权利要求1所述的装置,其特征在于,该装置还包括一用于与一测量仪表连通的接口。
22.如权利要求21所述的装置,其特征在于,该接口传送一电压或一电流。
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