CN1134751A - 分析设备及其使用方法 - Google Patents
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Abstract
一种用于测定样品液体中分析物的存在和/或其浓度的分析设备,它包括:外壳;在外壳中的装置例如化验条,用于选择性捕获加在设备上的样品液体中的分析物;在上述外壳第一末端上或靠近该末端的吸水的样品液体接收部件,该部件用于取样和将其传送到外壳中;在外壳上的窗,该窗位于远离外壳第一末端的位置;和一个帽子,该帽子在取样时套在窗上,然后再套到样品接收部件上。
Description
本发明涉及特别适合于供很不熟练人员例如供家庭成员用的那些分析设备的结构和使用方法。
分析尿样以便进行例如怀孕检查和预测***期的家用设备现在已广为出售。很多这种设备是基于免疫色谱学的原理,通常包括一个用塑料作的壳体,壳体中包含一条载带本底试剂的多孔化验条。使用者只须将尿样加在壳体的一部分上便可开始化验。化验结果在几分钟之内便可以用眼看到,使用者不必进行另外的操作。在EP-A-291194和EP-A-383619中已说明这种设备的例子,其内容已作为参考包含在本文中。
通常用高度吸水的部件进行样品收集,这种吸水部件构成设备的一部分,它可以容易地吸收样品液体,例如从尿流中吸收尿液。吸收部件可选择地凸出于设备的外壳以便施加样品。在任何情况下,吸水部件通常位于设备的末端或靠近该末端,使得可以将吸水部件引入到样品液体源中,例如尿流中,而同时尽量减少试样液体与使用者手的可能的直接接触。这种类型的设备有时有一个盖子,在取样之后使用者可以将盖子盖在吸水部件上。盖子的好处主要是卫生。
为显示化验结果,设备的外壳上有一个或多个的孔和窗,通过该窗可以看到设备的内部。如果样品液体通过这种观察窗进入设备,则起码损害设备的效率。样品液体进入设备内部的唯一路径最好是通过吸水的接收部件。为试图减小样品液体通过这种观测窗进入设备的危险,若干商品设备上装有透明材料片,该片靠着窗的内侧或外侧固定,起着密封件的作用。
本发明提供一种测定样品液体中分析物的存在和/或其浓度的分析设备,它包括:
空心外壳;
在上述外壳中的装置,用以选择性捕获所加样品液体中的上述分析物;
在上述外壳第一末端或靠近该末端的吸水的样品液体接收部件,上述接收部件构成收集样品液体并将吸收的样品液体送入上述外壳的装置;
在上述外壳上的窗装置,上述窗装置位于远离上述外壳的上述第一末端的位置,它使得上述分析物的检测可以在上述壳体的外侧完成;
盖子装置,啮合在上述外壳上,以便围住和密封上述吸水的样品接收部件,使其不与外部环境接触;
盖子装置,可脱开地啮合在上述外壳上,用于封闭上述窗装置。
为节省材料和尽量减小环境的影响,最好只配置一个盖子装置,上述一个盖子装置用于封闭上述吸水的试样接收部件和上述窗装置,但不是两个同时封闭。
当上述吸水的样品接收部件和上述窗装置中的一个或二者由上述盖子装置封闭时,上述盖子装置最好构成拿住上述设备的把手装置。
在本发明特别方便的形式中,上述外壳是细长的,上述第一末端是其一个端部。在此实施例中,上述盖子装置最好是套筒式装在上述细长外壳两个端部的一个或两个端部上。
本发明的分析设备与先有设备相比,具有许多优点。
a)该设备可以作得比较小,而无损于使用者的卫生和方便,或无损于化验结果的准确性。而且确实改进了准确度。因为在收集样品期间观察窗是封闭的,所以观测窗的位置可以更靠近样品收集器。如果化验设备的外壳中包括化验条,则化验条的工作长度可以更短,而且化验的速度和确度得到改善。较小的设备更便宜,因为需要的材料少。
b)设备可以以随时可供使用的形式提供给使用者。设备可以包裹在一个不透水的袋和香袋中,该袋可以用常规的方式,例如简单地撕开而取出设备。一当打开袋子便会发现,盖子装置封闭着观察窗,而吸水的样品收集器外露。在取样之后,可立即将盖子装置套在样品收集器上封闭它。
所谓要求盖子装置例如帽子应当“密封”吸水的样品接收部件使其在采样之后与周围环境隔离并不是指一定要完全气密地封闭接收部件。但是盖子装置应当充分地封闭样品接收部件,以防止由于滴落造成水分的显著损失,否则液体将流到可能与非密封的样品接收部件接触的外部物件例如布上。另外,还显著地减少了在使用期间的正常温度和湿度条件下水分由于从样品接收部件蒸发到周围大气而造成的可能的损失。就这方面来说,用常规的材料例如塑料和常规的模制方法是可行的,盖子部件对样品接收部件的密封基本上应是气密的。
在现在,商品家用型诊断设备一般提供定性或仅半定量的化验结果。例如孕妊试验只需要给出“是/否”的结果。但是还是需要更先进的家用技术。一个例子是进行人的***周期的监测,提供更准确的状态信息,然后利用这种信息来指导受孕,或确实地帮助避孕。要根据准确的数据才能很好地实现这一点。已经提出利用体液中分析物含量的变化,具体是例如尿和唾液液体中荷尔蒙代谢产物量的变化来指示***周期的改变状态。需要经常地例如每天对体液样品进行化验。计算和解释个别化验结果通常要求应用电子设备例如微处理机。一般的设想是,虽然使用者将长期保持一台微处理器或类似的装置,但只用许多一次性的化验设备进行体液样品分析,这些化验设备只用一次,用后便扔掉。
因此,在重复化验过程期间,将用一次性分析设备取体液样,然后执行基本化验。随后使用者将一次性的设备对着永久性的阅读器/微处理器,以便记录和解释个别的化验结果。通常这包括将一次性设备的一部分接合到或***阅读器/微处理器装置中的槽口或其它形状的插口中,以便相对于构成阅读器/微处理器一部分的阅读头可靠地定位一次性设备。因为阅读器/微处理器是使用者必需重复使用的装置项目,所以可以容易想像到,使用者担心这种过程。一次性分析设备的外部容易受样品液体的沾污。这种沾污的流体可能转到永久性的阅读器/微处理器上,为了卫生的原因可能不愿意再保存和再使用这种已沾污的装置项目。我们相信,为促使消费者接受这种分析***,必须要尽可能减少样品对一次性分析设备与阅读器/微处理器相接合的部分的沾污可能性。
另外,如果体液从设备上传送到阅读器/微处理器上,则它可能干扰阅读器/微处理器的准确性能,特别是当它集存在其中,或者干固,留下难于除去的垢时。
如果本发明的分析设备与单独的阅读设备联用,例如与可以解释分析设备中得到的化验结果的电子阅读器联用,则方便的是,使上述观察窗装置定位在上述外壳的可与阅读分析结果的装置匹配接合的部分上,上述匹配接合部分当除去上述盖子装置露出上述窗装置时便露出来。
本发明还提供有利的方式,使得用上述本发明的分析设备可以采集样品液体例如体液并分析该样品,其中,在包括将上述吸水的样品接收部件引入样品液体源的样品采集期间,可以利用封闭上述窗装置的上述盖装置拿住上述设备,随后再取下上述盖子装置,露出上述窗装置。最好在取下上述盖子装置露出上述窗装置之后,用同一个盖子装置密封上述吸水的样品接收部件。在采样和密封上述吸水的样品接收部件之后,最好可以利用密封上述吸水的样品接收部件的上述盖子装置拿住上述设备,以便例如将上述窗装置对着阅读上述分析结果的装置。
现在仅作为举例,参照附图说明本发明的优选实施例,这些附图是:
图1是本发明分析设备的总图,包括所用的帽子;
图2是图1设备的顶视图,帽子套在窗装置上;
图3还是图1设备的顶视图,但将帽子取下套在样品收集器上;
图4是正与阅读装置接合的图1设备的总图。
参照图1,设备包括具有上下两半11和12的外壳10。外壳是细长形状,具有矩形的侧向横截面。在外壳的两个纵向端部,该侧向横截面以单独一个台阶式被缩小,构成外壳的两个相对末端,每个末端可以装上帽子。该帽子套筒式装在外壳的末端上,紧贴外壳的中心部分。外壳10的每个延伸部分13和14的侧向横截面是相同的,使得同一个帽子15可以装在两个延伸部分中的一个上。延伸部分13部分地包住突出的吸水部分16,该吸水部分起着接收部件的作用,用于采集样品液体例如尿液。突出的吸水部件16和延伸部分13当帽子套筒武装在外壳的部分13上时二者均容放在帽子15中。外壳相对端的延伸部分14上装有阅读窗,通过该窗可以检测分析结果。在图1的上表面18上可以看到阅读窗17。
参考图2,图中示出从上面看到的化验设备,图中帽子15套筒式套在延伸部分14上。延伸部分13和吸水的样品接收部件16露出。此时可将样品液体20加在接收部件16上。
参看图3,在收集样品之后,可以延伸端部14上取下帽子15,并将其套筒式套在延伸部分13上。在这种配置方式中,帽子15封闭延伸部分13和现在是湿的样品接收部16二者,从而密封闭样品接收部分使其与外界环境隔离。此时露出包含阅读窗17的延伸部分14。因此通过阅读窗17可以观测到化验结果(作为图3的线30示出)。
在收集样品期间(图2)可以方便利用套在延伸部分14上的帽子15拿住设备。使用者的手指因此可以显著地与样品源例如尿流接触的样品接收部件16分开。在取样之后,可以暂时利用中央部11拿住设备,同时将帽子15取下来,转套到延伸部分13和接收部件16上。因而湿的样品接收部件16很合乎卫生地封闭在帽子15中,而在采样期间包含阅读窗的延伸部分14则受到保护而不会与任何样品液体接触。最大限度地减少了水份由于点滴、毛细管作用和蒸发从部件16进入外界环境而造成的水份损失。如图3所示,在将帽子15套筒式套在接收部件16上之后,可以利用帽子15清洁地拿住设备,并使具有阅读窗17的延伸部分14对着可以使分析结果定值的分开的阅读设备。
这种最后操作示于图4,图4中,在图3中所看到的阅读设备被倒转了,使得阅读窗现在位于延伸部分14的下侧。此时,延伸部分14位于阅读器/监测器14的凹槽40中。阅读传感器(用窗42表示)装在凹槽40中,当分析设备正确地插在凹槽中时,该阅读传感器贴近分析设备的阅读窗。阅读器41外壳的外部可以包括其它的部件,例如操作控制器43、目视输出装置例如液晶显示屏44和进入设备内部的例如用于换电池的入口45。
图1的设备可以方便地用塑料模制法(例如聚苯乙烯)制造,如果需要可以采用例如超声焊将外壳的上下两半焊接在一起。外壳10的内部可以包含多孔的载体条,该条从外壳的部分13沿外壳的长度延伸并通过阅读窗17。液体样品进入外壳中的多孔条只能通过样品接收部件16完成,这主要是由于在取样期间帽子15封闭了阅读窗17。帽子15可以是单独的一个塑料模制件。阅读器41的外壳也可以容易地用一种或多种塑料模制件制作。
内行的读者将会看到,设备在外壳10中的详细结构对本发明是不重要的。在阅读器41的外壳中既没有电子的又没有其它的结构部件。
应当认识到,外壳10和帽子15总的形状和尺寸可以在上述的基础上作重大的改变而不违背本发明的原理。同样,部分14和阅读器外壳上的凹槽或其它结合部件的相互作用形状也可以改变。纯粹作为例子的这种无关重要的改变可以是:
a)试样收集器16可以整个地装在延伸部分13中,并且只能通过延伸部13上的一个或多个孔采集液体样品;
b)如果需要,延伸部14上的阅读窗可以多于一个,化验结果可以以任何可直接为计算机使用的形式显示;
c)当化验设备供给消费者时,帽子可以装在设备上或单独供应;
d)化验设备可以具有任何便于制造或使用时便于拿住的侧向横截面或形状,例如圆形或椭圆形。
Claims (10)
1.一种用于测定样品溶液中分析物存在和/或其浓度的分析设备,包括:
空心外壳;
在上述外壳中的装置,用于选择性捕获加在其上的样品溶液中的分析物;
在上述外壳第一末端或靠近该第一末端的吸水的样品液体接收部件,后者构成收集样品液体和将收集的样品液体传送到上述外壳中的装置;
在上述外壳上其位置远离上述外壳的上述第一末端的窗装置,后者使得上述分析物的检测可以从上述外壳的外边看到;
可与上述外壳接合而封闭上述吸水的样品接收部件的盖子装置;
可脱开地与上述外壳接合的盖子装置,用于封闭上述窗装置。
2.如权利要求1所述的分析设备,其特征在于,仅提供一个盖子装置,上述一个盖子装置被配置成既可封密上述吸水的样品吸收部件,又可封闭上述窗装置,但不是同时封闭二者。
3.如权利要求1或2所述的分析设备,其特征在于,上述盖子装置构成拿住上述设备的装置,而同时上述吸水的样品接收部件和上述窗装置中的一个或两个由盖子封闭。
4.如上述任一项权利要求所述的分析设备,其特征在于,上述外壳是细长的,上述第一末端是其一个端部。
5.如权利要求4所述的分析设备,其特征在于,上述盖子装置(一个或两个)套筒式装在上述细长外壳两个端部中的一个端部上或两个端部上。
6.如上述任一项权利要求所述的分析设备,其特征在于,上述窗装置位于上述外壳上的与阅读分析结果的装置配合接合的部分上,当取下上述盖子装置露出上述窗装置时,上述配合接合部分便露出。
7.如上述任一项权利要求所述的分析设备,其特征在于,上述吸水的样品接收部件凸出于上述外壳。
8.一种使用如上述任一项权利要求所述分析设备的方法,其特征在于,利用封闭上述窗装置的上述盖子装置可以拿住上述设备,使上述吸水的样品接收部件引入样品液体源例如尿流中,然后取下上述盖子装置露出上述窗装置。
9.如权利要求8所述的方法,其特征在于,在取下上述盖子装置露出上述窗装置之后,用同一盖子密封上述吸水的样品接收部件。
10.如权利要求8或9所述的方法,其特征在于,在取样和密封上述吸水的样品接收部件之后,可以利用密封上述吸水的样品接收部件的盖子装置拿住上述设备,以便于使上述窗装置对着阅读上述分析结果的装置。
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EP93309055.7 | 1993-11-12 | ||
EP93309055A EP0653639B1 (en) | 1993-11-12 | 1993-11-12 | Analytical devices and methods of use thereof |
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CN1882835B (zh) * | 2003-11-14 | 2012-07-04 | 因韦尔尼斯医药瑞士股份有限公司 | 带有可密封的贮液池的液体样品分析装置 |
CN1828307B (zh) * | 2005-11-30 | 2011-02-02 | 因韦尔尼斯医药瑞士股份有限公司 | 用于检测流体样品中的分析物的装置和方法 |
CN102147419B (zh) * | 2005-11-30 | 2012-09-19 | 因韦尔尼斯医药瑞士股份有限公司 | 用于检测流体样品中的分析物的装置和方法 |
CN102590489A (zh) * | 2011-01-12 | 2012-07-18 | 泰博科技股份有限公司 | 生理信号感测***、生理信号撷取装置与可抛式装置 |
CN102590489B (zh) * | 2011-01-12 | 2014-03-12 | 泰博科技股份有限公司 | 生理信号感测***、生理信号撷取装置与可抛式装置 |
WO2020014945A1 (zh) * | 2018-07-20 | 2020-01-23 | 深圳市在田翊方科技有限公司 | 一种便携式取液装置 |
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