CN1527937A - 分析用具、具备分析用具的浓度测定装置用的穿刺元件一体化安装体及体液采取用具 - Google Patents
分析用具、具备分析用具的浓度测定装置用的穿刺元件一体化安装体及体液采取用具 Download PDFInfo
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Abstract
本发明涉及一种具有毛细管(31)、用于将样品液导入毛细管(31)的液导入口(20)、用于促进从液导入口(20)导入样品液的液导入促进装置(6)的分析用具(1A)。分析用具(1A)的结构例如是,在基板(2)上形成毛细管(31),液导入促进装置(1A)具有比基板(2)吸水性高的吸水层和相对于皮肤的紧密性比基板(2)高的粘接层之中的至少一者。
Description
技术领域
本发明涉及测定样品液的特定成份的浓度(例如葡萄糖浓度)时使用的分析用具、及安装于浓度测定装置上来使用且具备分析用具和穿刺元件的穿刺元件一体化安装体。
背景技术
目前,为了在家中或外出时都能简单地测定血糖值,简易型血糖值测定装置已被实用化。
作为血糖值测定装置,例如日本国特开2000-231号公报所提出的那样,有在浓度测定装置的前端部安装具备生物传感器及穿刺针的安装体并进行体液浓度测定的装置。该浓度测定装置在皮肤与生物传感器上所设置的液导入口接触的状态下,使穿刺针从生物传感器中突出来并使穿刺针穿刺皮肤,能使血液出液。另一方面,从皮肤流出的血液通过生物传感器的毛细管供给到反应部,构筑成液相反应体系,在浓度测定装置中,基于向液相反应体系施加电压时的响应电流值,定量地测定血糖值。
但是,在具备上述生物传感器的安装体中,如果皮肤相对于生物传感器的紧密性不充分,则会在生物传感器和皮肤之间产生间隙,血液沿生物传感器或皮肤从该间隙流出,有时不能从样品导入口适当地将血液导入。如果产生这样状态,就不能供给反应部充分量的血液,由于血液不足就不能准确地进行测定。
因此,提出了在生物传感器的样品导入口的周围涂敷疏水性涂料材料以防止血液的泄漏、并将液导入口和反应部邻近配置的方法。但是,在这些方法中,现状是不能充分抑制穿刺时血液的泄漏。
发明内容
本发明的目的在于:在利用具备毛细管的分析用具的浓度测定中,可确实地向毛细管供给进行样品分析的充分量的样品。
由本发明的第一方面提供的分析用具,其特征在于:具备毛细管、用于将样品液导入上述毛细管的液导入口、用于促进从上述液导入口导入样品液的液导入促进装置。
本方面的分析用具的构成例如是在基板上形成毛细管。这时,液导入促进装置的构成优选为例如具备比基板吸水性高的吸水层和相对于皮肤的紧密性比基板高的粘接层之中的至少一者。液导入促进装置优选是比基板弹性高的构成。
本方面的分析用具的构成优选为,例如具有将覆盖板介助隔离板层压在基板上的形态,并且具有在基板、隔离板及覆盖板的厚度方向一连贯通它们的贯通孔。这时,液导入口例如构成贯通孔,液导入促进装置嵌合于液导入口。液导入促进装置也可配置于液导入口的周围。也就是说,液导入促进装置优选配置在液导入口的附近,以便能促进向毛细管内导入样品液。液导入促进装置优选形成为环状,但也可以是圆弧状等其它形状。
液导入促进装置,在基板形成向侧方开放的缺口后,可保持在该缺口中。这时,液导入口的结构优选为向侧方开放。这样的液导入促进装置的构成优选为具有比基板吸水性高的吸水层和相对于皮肤的紧密性比基板高的粘接层之中的至少一者。液导入促进装置也可以是比基板弹性高的构成。
本发明第二方面是提供穿刺元件一体化安装体,其是具有穿刺元件及分析用具且安装于浓度测定装置来使用的穿刺元件一体化安装体,其特性在于:具备毛细管、用于将样品液导入上述毛细管的液导入口、用于促进从上述液导入口导入样品液的液导入促进装置。
本方面的分析用具例如其构成是在基板上形成毛细管。这时,液导入促进装置的构成优选为具备比基板吸水性高的吸水层和相对于皮肤的紧密性比上述基板高的粘接层之中的至少一者。液导入促进装置也可以是比基板弹性高的构成。
本方面的分析用具的构成优选为,例如具有将覆盖板介助隔离板层压在基板上的形态,并且具有在基板、隔离板及覆盖板的厚度方向一连贯通它们并用于允许穿刺元件的插通的贯通孔。这时,液导入口构成贯通孔,液导入促进装置嵌合于液导入口。液导入促进装置例如形成为环状。液导入促进装置可以配置在液导入口的周围。
本发明的第三方面是提供一种体液采取用具,其特征在于:具备毛细管、用于将体液导入上述毛细管的体液导入口、用于促进从上述体液导入口导入体液的体液导入促进装置。
本方面的体液采取用具例如是为了从皮肤采取流出的血液而使用的装置,体液导入促进装置在采血时与皮肤的采血部位接触。
体液采取装置的构成例如是在基板上形成毛细管。这时,体液导入促进装置的构成例如优选为具备比基板吸水性高的吸水层和相对于皮肤的紧密性比基板高的粘接层之中的至少一者。体液导入促进装置优选是比基板弹性高的构成。
附图说明
图1是第一实施方式的生物传感器的全体立体图。
图2是沿图1的II-II线的剖面图。
图3是从背面看图1所示的生物传感器的全体立体图。
图4是图1所示的生物传感器的分解立体图。
图5是环部件的截断一部分的立体图。
图6是血糖值测定装置的全体立体图。
图7是沿图6的VII-VII线的剖面图。
图8是表示穿刺体进入状态的与图7相当的剖面图。
图9是表示第二实施方式的生物传感器的主要部分的剖面图。
图10是表示第三实施方式的生物传感器的全体立体图。
图11是沿图10的XI-XI线的剖面图。
图12是图10所示的生物传感器的分解立体图。
具体实施方式
以下,以测定血糖值时所使用的生物传感器为例说明本发明的分析用具。
首先,参照图1~图4说明涉及第一实施方式的生物传感器。
生物传感器1A包括基板2、隔离板3及覆盖板4。该生物传感器1A是安装于后述的血糖值测定装置5(参照图7及图8)而使用的装置。
基板2形成为长矩形状的同时还具有血液导入口20。在血液导入口20中嵌入用于促进血液导入的环部件6。
环部件6具有与基板2同等程度的厚度,其厚度例如为70μm左右。该环部件6,如图5所示,是用一对粘接层61a、61b夹住吸水层60的结构。吸水层60是例如由无纺布形成为50μm左右的薄膜状并具有2~3g/g吸水性的物质。粘接层61a、61b具有与皮肤适度紧贴的粘合性。粘接层61a、61b优选由容易透过血液的材料形成。
如图4所示,在基板2的上面21上形成作用极22、对极23及反应部24。作用极22及对极23的一端部22a、23a形成弯曲的L字形状。反应部24形成为例如含有氧化还原酶及电子传达物质的固体状。作为氧化还原酶来说,例如使用葡萄糖氧化酶或葡萄糖脱氢酶。另一方面,作为电子传达物质来说,例如使用铁氰化钾。
由图1~图4所示,隔离板3及覆盖板4形成为比基板2小的长矩形状,并层压于基板2上,使得作用极22及对极23的另一端22b、23b露出。
在隔离板3上形成与血液导入口20连通的狭缝30。该狭缝30在将覆盖板3及隔离板4层压于基板2的上面21的状态下,构成毛细管31。狭缝30的端部位于血液导入口20的正上方,狭缝30的宽度比血液导入口20的内径小。因此,如由图2及图5所预想的那样,环部件6在嵌合于血液导入口20的状态下通过粘接层61a粘接于隔离板3上。因为该环部件6的嵌合及粘接,可以将环部件6只从血液导入口20嵌入,所以能通过极其简易的作业来进行。
在覆盖板4上形成穿刺针插入口40及空气出孔41。如图2所示,穿刺针插入口40是用于允许血糖值测定装置5(参照图7及图8)的穿刺针63a插入的开口,设置在血液导入口20的正上方。因此,其结构是,在生物传感器1A上形成一连贯通基板2、隔离板3及覆盖板4的空间,穿刺针63a可以贯通生物传感器1A。另一方面,空气出孔41通过毛细管31与血液导入口20连通。因此,由血液导入口20导入的血液由于毛细现象朝着空气出孔41进入毛细管31内。在该过程中,血液使反应部24溶解。这时,利用氧化还原酶,血液中的葡萄糖被氧化,另一方面,电子传达物质被还原。
以上所说明的生物传感器1A例如作为安装体的形态提供,而且作为安装体被装入血糖值测定装置上,为了测定血糖值而被使用。
如图6所示,血糖值测定装置5包括本体部50、安装部51及按压部52。在本体部50中设置有显示部50a。该显示部50a是为了显示测定结果等的装置,由LCD等构成。安装部51是用于装配安装体6的部位,从本体部50延伸出形成。按压部52是用于使穿刺针63a(参照图7及图8)开始移动的装置。
如图7所示,安装体6包括圆筒部60及底壁部61。圆筒部60以可外套在安装部51的前端部的方式构成。底壁部61具有向上方膨出的凹部62。凹部62是用于保持穿刺体63的装置,其开口部通过粘贴在底壁部61的生物传感器1A闭塞。穿刺体63包括穿刺针63a、凸缘部63b及被按压部63c。在凸缘部63b和生物传感器1A之间配置的螺旋弹簧64以势能增加状态被收容于凹部62内。
血糖值测定装置5还具有按压杆53及一对连接插头54。按压杆53是通过按压部52的操作向前端方向驱动的装置。按压杆53例如由众所周知的锁闭机构、利用电磁石的机构驱动。一对连接插头54是在将安装体6安装于血糖值测定装置5上时用于与生物传感器1A的端子部22b、23b接触的装置,与图外的电路相通。
在血糖值测定时,首先将安装体安装于血糖值测定装置5的安装部51。这时,如图2所很好地表示的那样,穿刺针63a位于生物传感器1A的穿刺针插入口40的正面,而且连接插头54与生物传感器1A的端子部22b、23b接触。
接着,将血糖值测定装置的前端部压在皮肤S上(参照图2),使得测定者的皮肤S紧贴着生物传感器1A的环部件6。这时,参照图2及图5可知,由于环部件6的表面为粘接层61b,所以皮肤S与环部件6进而与生物传感器1A成为紧贴的状态。
接着,操作按压部52(参照图1)进行穿刺操作。如果操作按压部52,如图8所示,按压杆53就向安装部51的前端部移动,按压杆53就妨碍安装体6的被按压部63c。由此,对穿刺体63作用向前端侧的力。由于生物传感器1A的穿刺针插入口40、狭缝30及血液导入口20连通并且在生物传感器1A的厚度方向上贯通,所以穿刺针63a贯通生物传感器1A,穿刺体63向前端部移动。由此,穿刺针63a的前端从生物传感器1A突出来,穿刺针63a穿刺皮肤S,促进血液从皮肤S流出。就这样的穿刺动作来说,由于环部件6具有贯通孔,所以即使环部件6嵌合于血液导入口20,该环部件6也会不妨碍穿刺针63a的移动。
再者,血糖值测定装置5的结构优选为,穿刺后利用弹簧的弹力等,按压杆53与穿刺体63离间。这样,穿刺体63也可以通过螺旋弹簧64的弹性恢复到图7所示的状态,抑制穿刺针63a刺入皮肤S的状态不必要地过长,减轻测定者的痛苦。
从皮肤S流出的血液通过血液导入口20被导入,其大部分被保持在环部件6的吸水层60。这时,因为皮肤S紧贴在环部件6上,所以一旦被导入到血液导入口20的血液漏到外部,也能抑制。另外,通过将血液吸收到吸收层60,能抑制血液从血液导入口20泄漏。而且,如果血液暂时地贮留在环部件6中,即使环部件6和皮肤S之间的紧密性不充分,由于血液通过与外面空气接触,血液也会凝固,由此可期待着环部件6和皮肤S之间的空隙被堵塞。通过这样的作用,也可以期待着能抑制血液的泄漏。另一方面,如果在吸水层60血液吸水,则促进从皮肤S的出液。这样,如果促进从皮肤S的出液、另一方面抑制血液的泄漏,就能确保测定时必要的充分量的血液。
被导入到血液导入口20的血液,由于毛细现象,向毛细管31内移动,溶解反应部24并构筑液相反应体系。血液导入口20贮留一定量的血液后将血液导入至毛细管31中。其另一方面,如上述的那样,在生物传感器1A内通过防止血液的泄漏能确保充分量的血液。因此,可确实地将血液供给至毛细管31进而反应部24。
通过连接插头54、作用极22及对极23将电压施加于液相反应体系,这时,液相反应体系和作用极22之间移动的电子量在血糖值测定装置5的电路中作为电流值被测定。在电路中,基于所测定的电流值,运算血糖值。
接着,参照图9说明第二实施方式的生物传感器。在图9中,与先前说明的生物传感器1A相同或同样的部件或元件标注相同的符号,此处省略重复说明。
在图9所示的生物传感器1B中,围绕血液导入口20B的开口面20Ba配置环部件6B。环部件6B例如是通过一对粘接层夹住吸水层的结构。当然,环部件6B也可省略吸水层及粘接层中的一方。
即使在该生物传感器1B中,也能享受与先前说明的生物传感器1A同样的效果。
第一及第二实施方式的生物传感器1A、1B并不限定于上述说明或图面所示的生物传感器,可以变更为各种生物传感器。
例如,作为环部件来说,可以使用具备吸水层及粘接层中的一方的部件。即使这时,也能得到防止血液泄漏的效果或促进出液的效果,其结果,也可得到确实地向毛细管内导入血液的效果。
也可以对环部件赋予弹性。如果这样,使测定者的皮肤与环部件接触时,利用环部件的弹性能提高环部件和皮肤的紧密性,还能抑制血液的泄漏。即使在环部件和皮肤之间存在尘埃或毛等也能得到这样的效果。
赋予环部件以弹性,既可以通过由弹性高的材料构成吸水层或粘接层来进行,也可以除吸水层或粘接层以外而另外设置弹性高的层来进行。作为用于赋予弹性的材料来说,例如可举出弹性体(硅树脂、丙烯酸酯树脂、橡胶等)或凝胶状化物。
也可以这样来配置,即,将以非贯通状构成的液导入促进部件嵌合到血液导入口或覆盖血液导入口,来代替环部件。这时,就液导入促进部件、至少被穿刺针插通的部分来说,需要使用穿刺针容易贯通的材料或结构。例如,作为液导入促进部件来说,也可以使用由具有贯通孔的第一部件和嵌合于贯通孔的第二部件构成的部件,另外也可以使用由相同材料形成的一张片材构成的部件。液导入促进部件可以是圆弧状等形状,只要是能发挥上述作用效果,对形状或材质等没有特别限定。
接着,参照图10~图12说明第三实施方式的生物传感器。在这些图中,对与先前说明的生物传感器1A相同或同样的部件和元件标注相同的符号,此处省略重复说明。
生物传感器1C不是以图7所示的安装体的形态安装于血糖值测定装置上,而是适于单独将生物传感器1C安装于血糖值测定装置上来使用而构成的。
在生物传感器1C中,狭缝30C形成为向侧方开放的狭缝。该开放部分构成血液导入口20C。因此,生物传感器1C的结构是,如图11很好地表示的那样,通过使出血的皮肤S与血液导入口20C接触,而导入血液。
另一方面,在基板2上形成向侧方开放的缺口部29,将液导入促进部件6C嵌入到该缺口部29中。在该状态下,液导入促进部件6C露出下面6Ca及侧面6Cb。液导入促进部件6C被赋予吸水性,或对侧面6Cb赋予粘接性。
就生物传感器1C来说,也可以抑制在血液导入时血液的泄漏,或促进皮肤流出血液,能确实地进行血液的导入。
在上述第一~第三实施方式中,以生物传感器为例进行了说明,但本发明的思想也适用于以专门采取体液(例如血液)为目的而构成的体液采取用具。该体液采取用具例如在图1~图4所示的生物传感器中,是省略了作用极22、对极23及反应部24的结构。
Claims (18)
1.一种分析用具,其特征在于:包括:
毛细管;
用于将样品液导入所述毛细管的液导入口;
用于促进从所述液导入口导入样品液的液导入促进装置。
2.根据权利要求1所述的分析用具,其特征在于:在基板上形成所述毛细管的分析用具中,所述液导入促进装置具有比所述基板吸水性高的吸水层。
3.根据权利要求1所述的分析用具,其特征在于:在基板上形成所述毛细管的分析用具中,所述液导入促进装置具有相对于皮肤的紧密性比所述基板高的粘接层。
4.根据权利要求1所述的分析用具,其特征在于:在基板上形成所述毛细管的分析用具中,所述液导入促进装置比所述基板弹性高。
5.根据权利要求1所述的分析用具,其特征在于:
在具有将覆盖板介助隔离板层压于基板上的形态的分析用具中,形成在所述基板、所述隔离板及所述覆盖板的厚度方向一连贯通它们的贯通孔。
6.根据权利要求5所述的分析用具,其特征在于:
所述液导入口在所述基板上形成并且构成所述贯通孔。
7.根据权利要求6所述的分析用具,其特征在于:
所述液导入促进装置嵌合于所述液导入口。
8.根据权利要求7所述的分析用具,其特征在于:
所述液导入促进装置形成为环状。
9.根据权利要求6所述的分析用具,其特征在于:
所述液导入促进装置配置于所述液导入口的周围。
10.根据权利要求1所述的分析用具,其特征在于:
在具有将覆盖板介助隔离板层压于基板上的形态的分析用具中,
所述基板具有在侧方开放的缺口,
所述液导入促进装置保持于所述缺口。
11.根据权利要求10所述的分析用具,其特征在于:
是在基板上形成所述毛细管的分析用具,
所述液导入促进装置具有比所述基板吸水性高的吸水层和相对于皮肤的紧密性比所述基板高的粘接层之中的至少一者。
12.一种穿刺元件一体化安装体,具有穿刺元件及分析用具并且安装于浓度测定装置上来使用,其特征在于:
所述分析用具具有:毛细管;用于将样品液导入所述毛细管的液导入口;用于促进从所述液导入口导入样品液的液导入促进装置。
13.根据权利要求12所述的穿刺元件一体化安装体,其特征在于:
所述分析用具是在基板上形成所述毛细管,
所述液导入促进装置具有比所述基板吸水性高的吸水层和相对于皮肤的紧密性比所述基板高的粘接层之中的至少一者。
14.根据权利要求13所述的穿刺元件一体化安装体,其特征在于:
所述分析用具,具有将覆盖板介助隔离板层压于基板上的形态,并且具有在所述基板、所述隔离板及所述覆盖板的厚度方向一连贯通它们并用于允许所述穿刺元件的插通的贯通孔。
15.根据权利要求14所述的穿刺元件一体化安装体,其特征在于:
所述液导入口在所述基板上形成并且构成所述贯通孔。
16.根据权利要求15所述的穿刺元件一体化安装体,其特征在于:
所述液导入促进装置形成为环状。
17.一种体液采取用具,其特征在于:
毛细管;
用于将体液导入所述毛细管的体液导入口;
用于促进从所述体液导入口导入体液的体液导入促进装置。
18.根据权利要求17所述的体液采取用具,其特征在于:
是用于采取从皮肤流出的血液的体液采取用具,
所述体液导入促进装置在采血时接触于所述皮肤的采血部位。
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Cited By (5)
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CN101819211B (zh) * | 2004-07-12 | 2011-12-14 | 爱科来株式会社 | 分析用具的反应槽的指定方法 |
CN102292020A (zh) * | 2009-01-23 | 2011-12-21 | 欧姆龙健康医疗事业株式会社 | 高效的体液收集装置及高精度的体液分析装置 |
CN102613978A (zh) * | 2011-01-31 | 2012-08-01 | 厚美德生物科技股份有限公司 | 检测试片 |
CN107638181A (zh) * | 2016-07-22 | 2018-01-30 | 希森美康株式会社 | 血液回收用具、血液回收用组合器具以及血液回收方法 |
US11285077B2 (en) | 2016-07-22 | 2022-03-29 | Sysmex Corporation | Blood collection device, blood collection set, blood collection method |
Also Published As
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EP1411352A4 (en) | 2007-11-07 |
EP1411352B1 (en) | 2012-01-11 |
US7879211B2 (en) | 2011-02-01 |
WO2003006980A1 (fr) | 2003-01-23 |
JP2011025091A (ja) | 2011-02-10 |
EP1411352A1 (en) | 2004-04-21 |
ATE540613T1 (de) | 2012-01-15 |
JPWO2003006980A1 (ja) | 2004-11-04 |
US20040171968A1 (en) | 2004-09-02 |
CN1273075C (zh) | 2006-09-06 |
JP4736323B2 (ja) | 2011-07-27 |
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