CN1199038C - 用于医疗诊断的流体装置 - Google Patents

用于医疗诊断的流体装置 Download PDF

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CN1199038C
CN1199038C CNB991106091A CN99110609A CN1199038C CN 1199038 C CN1199038 C CN 1199038C CN B991106091 A CNB991106091 A CN B991106091A CN 99110609 A CN99110609 A CN 99110609A CN 1199038 C CN1199038 C CN 1199038C
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R·J·沙特勒
H·乔
C·哈特曼
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LifeScan Inc
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Abstract

一种用于测量生物流体的被分析物的浓度或特性,特别是测量血液的凝固时间的流体医疗诊断装置。该装置在其一端具有一个用来导入试样的试样入口,以及在其另一端具有一个用来把试样吸入测量区的囊。一个通道把试样从试样入口传送到测量区,以及一个在测量区与囊之间的停止接合区阻挡试样流动。所需的测量可以通过把该装置放在一台仪器中进行,该仪器在试样与测量区中的试剂相互作用以后对试样的物理特性(通常是光学透射比)进行测量。

Description

用于医疗诊断的流体装置
相关申请
本申请要求保护1998年7月20日提交的美国临时专利申请60/093421的权利要求。
技术领域
本发明涉及一种用于测量生物流体中的被分析物的浓度或者特性的医疗诊断的流体装置。
背景技术
各种各样的医疗诊断程序包括对生物流体,诸如血液、尿液或唾液等的检验,这些医疗诊断以这类流体的物理特性或者该流体的某种成分诸如血清的变化为基础。物理特性可以是电子的、磁的、流体的或光学的特性。当测定光学特性时,这些程序可以利用一种用来盛装生物流体和试剂的透明的或半透明的装置进行。生物流体在光吸收方面的变化可以与该流体中的被分析物的浓度或者特性相联系。通常,把一个光源放在靠近该装置的一个表面处,而把一个检测器放在靠近该装置的对置表面处。该检测器测量通过流体试样发射出来的光。另一个办法是,可以把光源和检测器放在该装置的同一侧,在这种情况下,检测器测量由试样散射和/或反射的光。最后,可以把一个反射器放在该对置表面上或者靠近该对置表面处。后面的这种类型的装置称做“转移反射”装置,在该装置中,光首先通过试样区发散,然后经过再一次反射。贯穿于本说明书和所附权利要求书中涉及的“光”应理解为包括红外线和紫外线光谱以及可见光。涉及的“吸收”的意思是指一条光束穿过介质时的光强的减少;因此,它包括“真实的”吸收和散射。
透明的检验装置的一个实例在1994年2月3日公开的Wells等人的专利Wo 94/02850中进行了说明。该装置包括一个密封的壳体,该壳体是透明或半透明的、不透水的并且是刚性或半刚性的。一种鉴定材料盛装在该壳体中,同时一种或几种鉴定试剂也放在壳体中的预定位置。该壳体是开口的,试样只是在要对鉴定之前放入。鉴定试剂与试样中的被分析物的结合在鉴定结束时将导致所选定的试剂的光学特性,例如颜色的变化。该结果可以用肉眼辩认或者用光学仪器测出。
1971年11月16日授于Daris的美国专利3620676中公开了一种用于液体的比色指示器。该指示器包括一个可压缩的“半球形内腔”。使该球形受压缩和松开可以形成一个抽吸力,该抽吸力从流体源中吸出流体通过一个半管形内腔,该内腔的壁上压印有一个指示器。对于流入该指示器中的流体的控制措施只是在球形被松开时该球形的被压缩程度以及指示器入口管浸没在流体源中的长度。
1972年2月8日授于Hartig等人的美国专利3640267中公开了一种用于收集津液试样的容器,该容器具有弹性的可折叠的壁。这些壁在容器入口管装入待收集的流体中以前受到挤压。当松开时,这些壁就恢复到它们未受挤压时的状态,从而把流体吸入并通过入口管。同上述Davis装置一样,对流进指示器的流体的控制措施是很有限的。
1978年5月9日授于Lilja等人的美国专利4088448中公开了一种能对与试剂混合的试样进行光学分析的透明小容器。先把该试剂涂在内腔的壁上,然后使该内腔充满一种液体试样。该试样与试剂的混合可以引起一种可用光学方法检测的变化。
下面介绍的若干专利中公开了一些用于稀释和/或分析生物流体试样的装置。这些装置包括用来控制试样流动的阀状结构。
1984年1月17日授于Columbus的美国专利4426451中公开了一种多区域流体装置,该装置具有用来控制在区域之间的流体流动的可压力致动的装置。该装置利用了具有不同横断面的第一区与第二区之间的交界面处的液体弯月面上的压力平衡。当第一区和第二区都处于大气压力下时,表面张力将产生一个背压,该背压阻止从第一区至第二区的液体弯月面的发生。该分界面或“停止接合区”的构形应使只有当外部产生的压力作用在第一区中的液体上时,液体才流入第二区中,该压力足以把弯月面推入第二区中。
1989年9月19日授于Gibbons等人的美国专利中公开了在停止接合区的背压可以由在第一区内的液体上的流体静压力来克服(例如可以通过在第一区中设有一个流体柱)的结构。
1993年7月27日授于Shartle等人的美国专利5230866中公开了一种具有多个停止接合区的流体装置,在该装置中使表面张力产生的背压在停止接合区增大了;例如,可以通过捕获并且压缩在第二区内的气体来实现。然后在附加的流体静压力施加到第一区以使流体流入第二区中以前,把该压缩空气排出。通过同时改变多个停止接合区的背压,可以形成具有更低的最大背压的“断裂接合”。
1995年12月5日授于Schembri的美国专利5472603(也可见美国专利5627041)中公开了在停止接合区利用离心力来克服其背压的结构。当流动停止时,第一区处于大气压力加上离心产生的压力(该压力小于克服背压所需要的压力)作用下。第二区则处于大气压力作用下。为了恢复流动,把附加的离心力作用在第一区中,从而克服了弯月面的背压。第二区仍处于大气压力作用下。
1997年10月29日公开的Naka等人的欧州专利申请EP0803288中公开了一种用于分析试样的装置和方法,其中包括把试样通过吸力吸入该装置中,然后使试样与在分析部分中的试剂起反应。分析通过光学或电化学装置完成。在另一些实施例中,有多个分析部分和/或一个旁路通道。在这些部分中的流动是平衡的,无需使用停止接合。
1997年12月23日授于Yassinzadeh等人的美国专利5700695中公开了一种用于收集和处理生物流体的装置,该装置使用了一个“热压腔”,该腔用来提供使试样通过该装置的驱动力。
1998年4月7日授于Yassinzadeh等人的美国专利5736404中公开了一种用于决定血液试样的凝固时间的方法,该方法包括使试样的一端在一个通道内产生振动。该振动是通过交替地增加和减少作用在试样上的压力而产生的。
发明内容
本发明提供了一种用于测量生物流体中的被分析物的浓度或特性的流体诊断装置。该装置包括:
一个由中间层隔开的第一层和第二层,该第一层和第二层中的至少一层具有一个盖在其至少一部分面积上的弹性区,在该弹性区中,切口在中间层以及第一和第二层中形成;
a)一个用于把生物流体的试样导入该装置中的试样入口;
b)一第一测量区,在该测量区中,对试样的一个包括电子、磁、流体或光学参数的物理参数进行测量,该物理参数与流体的被分析物的浓度或特性有关;
c)一个具有一第一端和一第二端的第一通道,用来提供一条从在第一端处的该试样入口通到第一测量区的流体通路;
d)一个位于该第一通道的第二端的第一囊,该囊在至少第一或第二层中包括至少一部分弹性区并且具有一个至少与该第一测量区和第一通道的总和容积大约相等的容积;以及
e)一个在该第一通道中位于该第一测量区与第一囊之间的第一停止接合区,该接合区包括一个在至少该第一或第二层中的互相对准的通孔,该通孔上叠置有一第三层,其中,停止接合区停止流体流动。
在另一个实施例中,该装置包括:
由中间层隔开的第一层和第二层,该第一层具有一个盖在其至少一部分面积上的弹性区,在该弹性区中,凹口在中间层的第一表面以及第一层中形成,
a)一个用于把生物流体的试样导入该装置中的试样入口;
b)一个测量区,其中该试样在该区经受了一个包括电子、磁、流体或光学参数的物理参数的变化,该参数与该流体的被分析物的浓度或特性有关并且受到测量;
c)一个具有一第一端和一第二端的通道,用来提供一条从在该第一端处的试样入口通到该测量区的流体通路;和
d)一个位于该第一通道的第二端的囊,该囊在第一层中包括至少一部分弹性区并且具有一个至少与该测量区和通道的总和容积大约相等的容积;以及
一个在该通道中位于该测量区与囊之间的停止接合区,该接合区包括两个基本上垂直于该中间层的第一表面的两个通路,每个通路具有一个与该通道流体连通的第一端和一个与在该中间层的第二表面中的凹口流体连通的第二端,该凹口在通路的第二端之间提供了流体连通,其中,停止接合区停止流体流动。
该装置特别适合于在生物流体为纯粹的血液并且测量区具有一种能催化血液凝固级联的成分的情况下用来测量凝血酶原时间(PT时间)。
附图说明
图1是本发明装置的平面图;
图2是图1中所示装置的分解图;
图3是图1中所示装置的透视图;
图4是供本发明装置使用的一个仪表的简图;
图4A示出了图4所示仪表的一个元件的另一个例;
图5是用来决定PT时间的一条数据曲线;
图6是本发明装置的另一个实施例的平面图;
图6A、6B和6C示出了准许试样进入图6中所示装置的时间程序;
图7是一种具有并联的多个测量区,并联的多个停止接合区以及单个囊的装置的简图;
图8是一种具有串联的多个测量区、单个停止接合区、单个囊以及一个在试样入口上面的过滤器的装置的简图;
图9是一种具有配置成交替串联的多个测量区和多个停止接合区以及多个囊的装置的简图;
图10是一种包括并联的多个测量区、单个囊和单个旁路通道的装置的简图;
图11是一种具有串联的多个测量区、串联的多个停止接合区、串联的多个囊以及多个旁路通道的装置的简图;
图12是本发明的注模成形装置的分解图;以及
图13是图12中的装置的透视图。
具体实施方式
本发明涉及一种用于分析生物流体的流体装置。这种装置是可使该流体的一个物理参数或者该流体的一个成分与该流体中的被分析物的浓度或者与该流体的特性相联系的类型。虽然各种各样的物理参数,例如电子的、磁的、流体的或光学的参数都能作为测量的基础,但是光学参数的变化是优先选用的基础,因而下面的详述是指一种光学装置。该装置包括一个试样施加区;一个囊,该囊用来产生一个把试样吸入该装置中的吸力;一个测量区,在该区测量中试样将经受一个光学参数,例如光散射的变化;以及一个停止接合区,用来在充满测量区后使流动精确地停止。
最好是,该装置在测量区上方基本上是透明的,使得该区能够由在一侧的光源和在对置侧测量的透射光所照亮。对试样的测量可以是一个不变的参数,但是通常试样在测量区将经历一个变化,并且该透射光的变化是所研究的分析物或流体特性的一个度量。另一个办法是,从流体试样散射的光或者穿过试样并且再一次完全反射回来(通过一个在对置侧上的反射器)的光,可以由一个与光源放在同一侧上的检测器进行检测。
这种类型的装置适用于生物流体的各种分析化验,例如决定生物化学的或者血液的特性,或者测量在该流体中的蛋白质、激素、醣、类脂物、麻醉剂、毒素、气体、电解质的浓度等。用来进行这些化验的程序已经在有关文献中作了说明。在这些化验中,曾被介绍过的有下列文献:
(1)“产色第十二因子a鉴定(以及其他凝结因子)”:Rand,M.D.等人著,“血液”, 88,3432(1996)。
(2)“第十因子鉴定”:Bick,R.L著,“血栓形成和止血的无序”:“临床和实验室实践”。芝加哥,ASCP出版社,1992。
(3)“DRVVT(蝰蛇毒液稀释试验)”:Exner,T.等人著,“血液凝固剂”,“血纤维蛋白的溶解”, 1,259(1990)。
(4)“蛋白质的免疫浊度和免疫比浊鉴定”Whicher,J.T著,CRC Crit.Rev.“临床实验室科学“, 18,213(1983)。
(5)“TPA鉴定”:Mann,K.G.等人著,“血液” 76 755(1990);以及Hartshorn,J.N等人著,“血液”, 78,833(1991)。
(6)“APTT(部分致活凝血致活酶的时间鉴定”:Proctor,R.R.和Rapaport,S.I.Amer.J.“临床病理学”, 36 212(1961);Brandt,J.T和Triplett,D.A.Amer.J.“临床病理学”, 76530(1981);以及Kelsey,P.R.Thromb.Haemost, 52,172(1984)。
(7)“HbA1c鉴定(糖基化血红蛋白鉴定)”:Nicol,D.J.等人著;“临床化学” 29,1694(1983)。
(8)“全血红蛋白”:Schneck等人著,“临床化学” 32/33,526(1986);以及美国专利40888448。
(9)“第十因子a”:Vinazzer,H.,Symp.Dtsch.Ges.“临床化学”,203(1977),ed.BY Witt,I。
(10)“氧化氮的色度鉴定”:Schmidt,H. H.等人著,“生物化学”, 2,22(1995)。
本发明装置特别适用于测量凝血时间,“凝血酶原时间”或“PT”时间,有关这类装置的详细说明将在下面进行。为使该装置适合于例如上面列出的应用场合所需作出的改进仅仅需要进行常规试验即可。
图1是本发明的装置10的平面图。图2是该装置的分解图以及图3是该装置的透视图。在囊14被压缩以后,把试样放在试样入口12上。显然,与囊14的切口相邻接的层区26和/或层区28必须是弹性的,以使囊14能够受压缩。大约0.1毫米厚度的聚酯具有适当的弹性和弹力。最好是,顶层26的厚度约为0.125毫米,底层28的厚度约为0.100毫米。当松开该囊时,吸力通过通道16把试样吸到测量区18,该区最好盛装有试剂20。为了保证测量区18能够用试样充满,囊14的容积最好至少大约等于通道16和测量区18的总和容积。如果测量区18可以从下面被照亮,层28在它与测量区18相邻接处必须是透明的。对于PT化验来说,试剂20包含促凝血酶,该酶不含通常能在冻干的试剂中发现的膨松试剂。
如图1、2和3中所示,停止接合区22与囊14和测量区18相邻接;然而,通道16的延续部分可以在停止接合区22的两侧中的任一侧或者两侧上,从而使停止接合区与测量区18和/或囊14相隔离。当试样到达停止接合区22时,试样的流动就停止。对于PT测量来说,当试样到达该位置时使它的流动停止是重要的,以便能再生“红细胞钱串成形”(红细胞叠合),这种停止在使用本发明监测凝血时是一个重要步骤。停止接合区的工作原理在美国专利5230866中作了说明,其内容通过引用结合在本文中。
如图2中所示,所有上述组成部分都通过在中间层24中的切口而形成,该中间层夹在顶层26与底层28之间。最好层24是两面胶粘带。停止接合区22是通过在层26和/或28中的另外一个切口而形成的,该切口与层24中的切口对准并且由密封层30和/或32所密封。最好是,如图中所示出的,该停止接合区包括具有密封层30和32的层26和28的切口。用于停止接合区22的每个切口至少与通道16的宽度一样宽。在图2中还示出了一个用来盖住试样入口12的任选过滤器12A。该过滤器可以从纯粹的血液试样中分离出红细胞和/或可以包含一种试剂,该试剂可与血液相互作用以便提供附加的信息。适当的过滤器包括一个各向异性薄膜,最好是可以从加拿大多伦多市的光谱诊断公司买到的聚砜薄膜。任选的反射器18A可以装在(或者靠近)层26的一个表面上并且位于测量区18的上面。如果有反向器存在的话,该装置就变成一个trans flectance装置。
使用图1、2和3的带条的方法可以通过参照图4中示出的仪器零件而取得理解,该仪器设想为一个自动化仪表。或者,也可以采用手动操作。(在这种情况下,在把试件放在试件入口12上以前,先用手压下囊14,然后再松开)。使用者进行的第一步是接通该仪表,由此使带条检测器40、试样检测器42、测量装置44和任选的加热器46通电。第二步是插入该带条。较好地,该带条在其至少一部分面积上是不透明的,从而使一个插入的带条将阻挡由检测器40b的发光二极管40a的照明。(最好是,中间层由一种不透明材料制成,从而使背景灯光不能进入测量装置44中)。由此,探测器40b探测出带条已经插入并且起动囊致动器48以压缩囊14。然后,仪表显示器50指示使用者把试样放在试样入口12处,因为第三步也是最后一步使用者必须开始测量程序。空的试样入口是可以反射的。当试样被导入试样入口后,它吸收了来自发光二极管42a的光,因此减少了反射到检测器42b上的光,这种光的减少又发信号给致动器48以松开囊14。通道16中的吸力把试样通过测量区18引到停止接合区22。来自发光二极管44a的光经过测量区18,而检测器44b当试样凝固时检测从该试样发出的光。在具有多个测量区时,测量装置44对于每个测量区包括一个发光二极管/检测器对(像44a和44那样)。分析作为时间的函数(如下面所述)的发射光可以作出PT时间的计算,该时间显示在仪表显示器50上。最好是,试样温度由加热器46保持在37°左右。
如上所述,检测器可以简单地通过检测光信号的(光谱)反射的减少而检测出在试样入口12处的试样,该光信号由发光二极管42a发射并且由检测器42b检测。但是,该简单装置不能在纯粹的血液试样与某些弄错了放在试样入口处的其他液体(例如血清)或者甚至是可能接近试样入口12的一个物体(例如手指)之间容易地进行区别,从而使该装置可能会错误地断定已经放有一个适当的试样。为避免这类错误,另一个实施例测量来自试样入口的漫反射。该实施例示于图4A中,图中示出检测器42b位于与带条10的平面相垂直的位置。在图4A中所示装置的情况下,如果把纯粹的血液试样放在试样入口12处,由检测器42b检测出的信号先是由于血液试样的散射而突然地增加,然后又由于红细胞钱串形成而减少(下面将说明)。因此,为检测装置42编制的程序设计在使致动器48在松开囊14以前需要这种类型的信号。延迟几秒钟松开囊14基本上不会影响仪表指示(下面将说明)。
图5示出了一条典型的“凝固特性”曲线,图中来自检测器44b的电流作为时间的函数绘出。首先,在测量区由检测器以时间位置1检测血液。在位置1与2之间的时间间隔A中,血液充满了测量区。在该时间隔期间,电流由于红细胞的光散射而减少,因此它是红细胞比率的一个近似的度量值。在位置2处,试样已充满了测量区并且处于静止状态,其运动已由停止接合区所阻止。红细胞象硬币一样开始层叠(红细胞钱串形成)。该红细胞钱串效应在位置2与3之间的时间间隔中可以使通过试样的光透射增加(并且使散射减少)。在位置3处,凝固血块形成终止了红细胞钱串的形成并且通过试样的光透射达到一个最大值。PT时间可以根据在位置1与3之间的间隔B或者位置2与3之间的间隔计算。此后,血液状态从液体改变成半固体凝胶并使光透射产生相应的减少。在最大值3与终点值4之间的电流减少值C与试样中的血纤维蛋白原相关。
如上所述,图2中的装置最好通过把热塑料薄板26和28层叠在其两个表面上都有胶粘剂的热塑料中间层24上而形成。构成在图1中所示的各个组成部分的切口可以例如通过对层24、26和28的激光切割或冲切而制成。另一个办法是,该装置可以由模压塑料制成。最好是,薄板28的表面是亲水的。(薄板9962,可以从3M,St.Paul,MN购得)。但是,该表面无需被弄湿,因为没有毛细管吸力试样流体也将充满该装置中。因此,薄板26和28可以是未经浸渍的聚酯或其他热塑料板,这在本技术领域是众所周知的。同样,由于重力与充满无关,该装置可以在任何方向工作。与具有许多排出孔的毛细管填充装置不同,试样可能通过其中产生泄漏,本发明的装置在试样施加以前可通过试样入口排出,这意味着首先插入仪表中的这部分带条是没有孔的,从而减少了受污染的危险。
图6是本发明的装置的另一个实施例的平面图,图中该装置包括一个使通道16与囊14相连通的旁路通道52。该旁路通道的作用与工作通过参考图6A,6B和6C就能够理解,图中示出了一个时间程序,在该程序进行过程中,试样被吸入装置10中以便进行测量。
图6A示出了在使用者已将试样施加到带条上,同时囊14受压缩以后的情况。这种情况通过施加一滴或多滴血就可以实现。
图6B示出了松开囊以后的情况,在入口通道16中的合成减压最初把试样吸入测量区18内。当试样到达停止接合区22后,试样受到一个背压,该背压使它停止并且使另一个试样吸入该旁路通道中。
图6C示出了取得读数时的情况。试样此时被隔离并且在测量区18中处于静止状态。过量试样和/或空气已被吸入旁路通道52中。
图6的旁路通道提供了优于图1-3的“基本”带条的工作的一个重要的改进。在基本带条中,停止接合区22在试样充满测量区18以后就使试样的流动停止。如前面所说过的,为促进红细胞钱串形成,停止试样流动是很重要的。又如前面所说过的,停止接合区由于流动通道的横截面发生突然变化处作用在该流体的前缘处的弯月面上的表面张力,的作用而实现了该流动停止。在基本带条中,当在试样一侧上的压力保持与大气相通时,在停止接合区的囊一侧上的压力则低于大气压力。因此,在两侧有环境压力不平衡的情况。不平衡愈大,下述风险也就愈大,即停止接合区将发生泄漏并且试样将流过停止接合区,与红细胞钱串发生干涉,并因而提供了不精确的PT值。
旁路通道52可使该风险减至最小。停止接合区的囊一侧上的减压可将试样吸入旁路通道中(图6B、6C),直至环境压力与在停止接合区的两侧上的大气压力相等为止。应注意在囊一侧上的(减)压是比较不受控制的。由于可使停止接合区的两侧上的压力均匀,旁路通道52允许使用具有更大吸力的较大的囊。而较大的囊又能提供该装置的更加可靠的工作。
图7示出了一个其中有多个(图中为3个)“并联”测量区的本发明的实施例。也就是说,通道116P、216P和316P基本上同时充满(假定它们具有相同的尺寸)。图7中所示的使通道和测量区都充满血液的情况,如上所述,可以通过把试样放在试样入口112处,同时使囊114受压缩,然后再松开囊114,即可实现。如上所述,第一步是把试样放在试样入口112处,同时使囊114受压缩。第二步是松开该囊。试样就流动到测量区118P、218P和318P中,当试样分别到达停止接合区122P、222P和322P时,流动就停止。任选的第二和第三测量区可以包含例如试剂,该试剂可用来中和血液中存在的干扰物(例如肝膦酯),或者它可对PT测量提供内部控制,或者它可测量其他血液参数(例如APPT)。
图8是一个其中有多个“串联”测量区(其含义为这些测量区顺序地充满)的实施例的简图。在该实施例中,测量区118S、218S和318S通过单个通道116S顺序地充满,直到试样到达停止接合区122S为止。这种结构的潜在缺点是,从一个测量区传送到下一个测量区的试样可能带有过量的试剂。
图9是装置的另一个实施例的简图,该装置适用于多次顺序试验。在该实施例中,停止接合区122T、222T和322T允许使用者控制测量区118T、218T和318T的顺序充满时间。在工作中,囊114、214和314在血液试样放在试样凹口112处以前全都受到压缩。然后,囊114被松开,血液就被吸入测量区118T并流动到停止接合区122T处。在一个选定的随后时间后,囊214被松开,使血液能突破停止接合区122T并且进入测量区218T流动到停止接合区222T处。最后,当使用者想利用测量区318T时,囊314被松开,使试样能突破停止接合区222T并且流动到停止接合区322T。图9中的装置必须精心地制作,因为由松开一个囊所引起的把试样吸入该装置中的力必须与由一个停止接合区所作用的反向力相平衡。如果吸力太大,停止接合区可能会过早地允许试样通过;如果吸力太小,当需要通过时,该吸力将不能吸引试样通过停止接合区。
图10示出了本发明装置的一个最佳实施例。它是一个包括旁路通道152P的并联的多通道装置。旁路通道152P在该装置中所起的作用类似于旁路通道52在图6的装置中所起的作用,这在上面已经说明过了。测量区118P含有促凝血酶。较好是,测量区218P和318P装有控制装置,最好是下面所述的控制装置。测量区218P含有促凝血酶,牛洗提液和重组细胞第七因子a。该成分是选择用来通过对抗一种抗凝血剂(例如华法令(Warfarin))的作用而使血液试样的凝固时间归一化的。测量区318P只含有促凝血酶和牛洗提液,以部分地克服抗凝血剂的作用。因此,在该带条上要作出3次测量。试样的PT时间(主要关心的测量)是在测量区118P进行测量。但是,这种测量只有在测量区218P和318P产生的结果在一个预定范围内时才是有效的。如果这些可控测量中的任何一个或者两个都位于该范围之外,就需要重复测试。扩展的停止接合区422停止了在所有3个测量区中的流动。
图11示出了一种包括旁路通道152S和252S以允许测量区118T和218T的定时充满的装置。除下述内容外,图11中的装置的工作与上述图9中的装置的工作相类似。第一旁路通道152S具有一个区域,其中涂有一种能造成凝固的试剂,例如促凝血酶。当在试剂区118T作出第一次测量时,在已经被吸入到旁路通道152S的血液中就已形成凝固。因此,当使第二囊解压时,血液就受阻不能通过旁路152S吸入,而是通过停止接合区122T被吸入测量区218T和旁路通道252S。
所有上述图形中示出的本发明的装置都是一种层叠的带条结构形式;但是,该装置也可以是一种示于图12和13中的注模成形结构形式。图12是一种包括有中间层124夹在其中的顶层126和底层128的注模成形装置110的分解图。该中间层在其上表面上具有形成试样入口112、通道116、测量区118和任选的旁路通道152的凹槽。停止接合区122穿过中间层124的厚度。试样流动在停止接合区122与通道A之间的交界面处停止,该通道是由在下表面上的一个凹槽形成的。因此,试样通过通道116从试样入口112被吸入测量区118并流动到停止接合区112处。
注模成形装置的工作原理与上述装置的相同。由于各式各样的通道截面都是可行的,因而模制结构在停止接合区以及该装置的其他组成部分的设计方面提供了较大的灵活性。该模制结构还具有更大的刚性,不过它的价格更加昂贵。
下列实例以其各种实施例来说明本发明,但它们并非意在以任何方式来限制本发明。
实例1
本发明的带条制作首先把一个夹在两个分离衬板之间的两面胶粘带(RX 675 SLT,可从Scapa Tapes,Windsor,购得)送入一个层压和旋转冲切转换装置中。图6中所示的型式(停止接合区除外)可通过切开上分离衬板和胶粘带而成,但不切开下分离衬板,它在随后作为废物连同从胶粘带上切下的料一起清除。把处理成亲水的聚酯薄膜(3M 9962,可从3M,St.Paul,MN购买)层叠在胶粘带的外露的下侧。然后把试剂(促凝血酶,可从OrthoClinical Diagnostics,NJ购买)使用Hewlett Packard,Corvallis,OR的印刷头51612A通过气泡喷射印制聚酯薄膜的试剂区(18)上。在未处理的聚酯薄膜(AR1235,可从AdhesivesResearch,Glen Rock,PA购买)上切出一个试样入口,然后对准层叠在两面胶粘带的上面(在取走分离层以后)。然后用冲模穿过该叠层件的3层切出停止接合区。最后,把单面胶粘带(MSX4841,可从3M,st.Paul,MN购买)放在聚酯层的外部以便将停止接合区密封。
实例2
一种与实例1中所述程序相类似的程序用来制作在图10所示出的这种带条。通过气泡喷射印制在试剂区118P、218P和318P上的试剂分别为:促凝血酶;促凝血酶,牛洗提液和重组细胞第七因子a;以及仅仅是促凝血酶和牛洗提液。牛洗提液(等离子钡柠檬酸牛提取液)可从Haemotologic Technologies,Burlington,VT购买;以及重组细胞第七因子a可从American Diagnostica,Greenwich,Ct购买。
使用本实例的带条对纯粹的血液试样所作的测量得出的曲线类型在图5中示出,该曲线适合每个测量区。取自控制装置(测量区218P和318P)的曲线的数据用来修正来自测量区118P的曲线的数据。因此,与使用只有单个测量区作出的PT曲线相比,该PT曲线的确定具有更大的可靠性。
实例3
图12和13中的装置是通过把中间层124夹在顶层126和底层128之间而形成的。该中间层和底层都是注模成形的聚碳酸酯(Lexan*121)并且分别具有6.3毫米和1.5毫米的厚度。顶层126是通过冲切0.18毫米厚的Lexan*8010薄板制成的。在实例1中的试剂放在试剂区118上以后,各组成部分都进行了超声焊接。Lexan*材料可从Genral Electric,Pittsfield,MA购买。
我们已经对本发明作出了充分的说明,对于本领域的普通技术人员来说十分显然的是,只要不脱离本发明的精神和范围,可以对本发明作出各种改进和变化。

Claims (21)

1.一种用于测量生物流体中的被分析物的浓度或特性的流体诊断装置,该装置包括:
由中间层隔开的一第一层和一第二层,该第一和第二层中的至少一层具有一个盖在其至少一部分面积上的弹性区,在该弹性区中,切口在中间层以及第一和第二层中形成,
一个用于把该生物流体的试样导入该装置中的试样入口;
一第一测量区,在该测量区中,对试样的包括电子、磁、流体或光学参数的物理参数进行测量,该物理参数与该流体的被分析物的浓度或特性有关;
一具有一第一端和一第二端的第一通道,用来提供一条从在该第一端处的该试样入口通过该第一测量区的流体通路;
一个位于该第一通道的第二端的第一囊,该囊在至少第一或第二层中包括至少一部分弹性区并且具有一个至少与第一测量区和第一通道的总和容积相等的容积;以及
一个在该第一通道中位于该第一测量区与第一囊之间第一停止接合区,该停止接合区包括一个在第一或第二层中的互相对准的通孔,该通孔上叠置有一第三层;
其中,在所述停止接合区停止所述流体流动。
2.如权利要求1所述的装置,其特征在于,该试样入口包括在该第一和中间层中的互相对准的通孔。
3.如权利要求1所述的装置,其特征在于,该第一停止接合区还包括一个在第一或第二层中与该第一通孔相对准的第二通孔,该第二通孔上叠置有一第四层。
4.如权利要求1所述的装置,其特征在于,该装置还包括一个旁路通道,用来提供一条无需经过第一测量区和第一停止接合区就可从第一通道到该囊的附加通路。
5.如权利要求1所述的装置,其特征在于,至少该第一或第二层是透明的与第一测量区相邻接,并且所测量的该物理参数是光的透射。
6.如权利要求5所述的装置,其特征在于,该装置还包括一个邻接第一测量区的反射表面。
7.如权利要求1所述的装置,其特征在于,该试样的物理参数在测量区中经历一个变化。
8.如权利要求7所述的装置,其特征在于,其用于测量纯粹的血液的凝血酶原时间的装置,其中,该第一测量区合有一种能促进血液凝固的成分。
9.如权利要求8所述的装置,其特征在于,该成分包括促凝血酶。
10.如权利要求1所述的装置,其特征在于,该装置还包括一个与该试样入口相邻接的过滤器,用来过滤被导入该试样入口的生物流体。
11.如权利要求10所述的装置,其特征在于,该过滤器包括一个各向异性的薄膜。
12.如权利要求11所述的装置,其特征在于,该过滤器材料是聚砜。
13.如权利要求1所述的装置,其特征在于,该装置还包括一个在该第一测量区与该停止测量区之间的与第一测量区相同的附加测量区。
14.如权利要求1所述的装置,其特征在于,该装置还包括至少一个从该第一通道至该囊且与之并联的另外的流体通路,每个这样的另外通路包括一个相应的测量区和停止接合区。
15.如权利要求4所述的装置,其特征在于,该第一测量区包含有一种能促进血液凝固的成分,该生物流体是纯粹的血液,以及所测量的特性是凝血酶原时间。
16.如权利要求15所述的装置,其特征在于,该装置还包括至少一个从该第一通道至该囊的另外的流体通路,每个这样的另外通路包括一个对应的测量区和停止接合区。
17.如权利要求16所述的装置,其特征在于,一第一另外通路是通向一个可克服抗凝血剂的作用的测量区,以及一第二另外通路是通向一个可部分克服抗凝血剂的作用的测量区。
18.如权利要求17所述的装置,其特征在于,在该第一另外通路中的测量区包括促凝血酶,牛提取液和重组细胞第七因子a,以及在该第二另外通路中的测量区包括促凝血酶和牛提取液。
19.如权利要求13所述的装置,其特征在于,该装置还包括至少一组在该第一停止接合区与该第一囊之间的通道、测量区和停止接合区,以及一个与该第一囊相邻接的附加的囊用于每个这样的组。
20.如权利要求19所述的装置,其特征在于,该装置还包括一个从该第一通道至该第一囊的旁路通道,以及一个从每个附加组的通道至该对应的附加囊的附加旁路通道。
21.一种用于测量生物流体中的被分析物的浓度或特性的流体诊断装置,该装置包括:
由中间层隔开的一第一层和一第二层,该第一层具有一个盖在其一部分面积上的弹性区,在该弹性区中,凹口在该中间层的第一表面以及第一层中形成,
一个用于把生物流体的试样导入该装置的试样入口;
一个测量区,该试样在该区中经受了一个包括电子、磁、流体或光学参数的物理参数的变化,该特性与该流体的被分析物的浓度或特性有关并且受到测量;
一个具有一第一端和一第二端的通道,用来提供一条从在该第一端处的试样入口通到该第一测量区的流体通路;和
一个位于该第一通道的第二端的囊,该囊包括在第一层中的弹性区并且具有一个至少与该测量区和通道的总和容积相等的容积;以及
一个在该通道中位于该测量区与囊之间的停止接合区,该停止接合区包括两个垂直于该中间层的第一表面的两个通路,每个通路具有一个与该通道流体连通的第一端和一个与在该中间层的第二表面中的凹口流体连通的第二端,该凹口在通路的第二端之间提供了流体连通;
其中,在所述停止接合区停止所述流体流动。
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US20020110922A1 (en) 2002-08-15
DK0974840T3 (da) 2003-03-31
KR20000011826A (ko) 2000-02-25
EP0974840A2 (en) 2000-01-26
ES2189353T3 (es) 2003-07-01
DE69904403D1 (de) 2003-01-23
US20020064480A1 (en) 2002-05-30
IL130807A0 (en) 2001-01-28
KR100634714B1 (ko) 2006-10-17
EP0974840A3 (en) 2000-03-08
US7022286B2 (en) 2006-04-04
TW411268B (en) 2000-11-11
CA2277639A1 (en) 2000-01-20
JP2000055911A (ja) 2000-02-25
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IL130807A (en) 2003-11-23
US6521182B1 (en) 2003-02-18
US20020110486A1 (en) 2002-08-15
EP0974840B1 (en) 2002-12-11
US20030156984A1 (en) 2003-08-21
US20030031594A1 (en) 2003-02-13
US20030156983A1 (en) 2003-08-21
NO993536D0 (no) 1999-07-19
ATE229649T1 (de) 2002-12-15
US20040109790A1 (en) 2004-06-10

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