CN1127663C - 一种血液葡萄糖监测装置 - Google Patents

一种血液葡萄糖监测装置 Download PDF

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CN1127663C
CN1127663C CN97119697A CN97119697A CN1127663C CN 1127663 C CN1127663 C CN 1127663C CN 97119697 A CN97119697 A CN 97119697A CN 97119697 A CN97119697 A CN 97119697A CN 1127663 C CN1127663 C CN 1127663C
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CN1186243A (zh
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B·泽阿布
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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    • B01L99/00—Subject matter not provided for in other groups of this subclass
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements

Abstract

一种改进的血液葡萄糖监测装置，包括一血液葡萄糖检测条和一个护盖可降低在血液葡萄糖检测条与一血液葡萄糖检测仪一起使用时受污染的风险。该装置的检测条是粘着至护盖的顶表面，护盖最好由一片透明塑胶切割而成。此护盖允许检测条的样本接收表面被接触，但防止使用者污染检测仪，因为当检测条放置在检测仪内时，此护盖覆盖住检测仪的邻接检测条的一部分。类似地，此护盖可防止使用者接触检测仪的可能已污染的区域。在医院或许多人员共用同一检测仪的其它场所中，此改进的监测装置具有特别的优点。

Description

一种血液葡萄糖监测装置
本发明是关于一种血液葡萄糖监测装置，更详细讲是关于一种与一护盖形成整体的血液葡萄糖检测条，以便降低检测仪污染的风险。
近几年来，医疗诊断工作者关注于因暴露在先天血液疾病(例如爱滋病与肝炎)的健康问题。因此，涉及检测血液的诊断必需将患者血液污染设备与人员的风险，以及将他人血液污染病人的风险减到最小。血液葡萄糖监测器是为众多医疗诊断装置中，最被广范使用者之一。单在美国，就有一千四百万人患糖尿病。为了避免严重的医疗问题，例如视力减损、循环问题、肾衰竭等等，许多这类患者在一经常性的基础上监测他们的血液葡萄糖，然后再采取必要的措施以便维持他们的血液葡萄糖浓度在一可接受的范围内。
在进行血液葡萄糖检测时，血液的污染最为人所关心的。例如，在使用最普通型式的全血液葡萄糖检测仪(光度计)时，血液葡萄糖的测定是大致取自一施加至一个置于检测仪上的检测条上的血液样本。为了放置患者手指的血液样本，患者的手指必需放置在靠近检测条上方的位置处以便将血液样本沾上检测条。因此便有患者的手指可能与检测仪接触的风险。虽然，当检测仪仅供一人使用时，不会产生严重的健康问题，但假使检测仪在一医院使用时，就有横向污染的潜在问题。检测仪上的血液对医护工作者的健康构成潜在的危险。
已经公开了许多用以降低因诊断检测而污染患者或其它人的风险的装置。
在1990年8月28日颁发给Sugarman等人的美国专利4,952,373中，揭示了一种防止诊疗片上多余的液体流入与此诊疗片共同使用的检测器上的屏蔽，此种屏蔽是由薄塑料或金属模制而成并设置在大致如信用卡般大小的诊疗片上。
在1992年3月31日颁发给Brenneman的美国专利5,100,620中，揭示了一种具有中间毛细管的倒置的漏头状本体以便自一远端的样本放置点运送液体样本至一检测面。此种装置可用以将针刺手指所流出的血液转送至试剂片上。
根据本发明，一血液葡萄糖监测装置包含：
a.一血液葡萄糖检测条，它被插入一血液葡萄糖检测仪的预定位置中并具有一个可放置血液样本以供检测仪测量血液葡萄糖浓度的样本接收区；及
b.一护盖，它固定在检测条上，邻接至少一部分样本接收区并且在检测条就位时覆盖检测仪的一部分。
本发明的检测装置允许一个人使用传统的光度血液葡萄糖检测仪并在检测仪上施加样本，但可降低他污染检测仪或被检测仪污染的风险。本装置是一次性使用的，而在说明书与权利要求中的“装置”与“一次性使用的”术语是可互用的。
图1是根据本发明的检测装置及与之一起使用的检测仪的分解透视图。
图2是图1所示的检测装置装设在图1的检测仪中的透视图。
图3是本发明的检测装置的顶视平面图。
图4是图3的检测装置的剖面图。
图5是本发明的检测装置的另一实施例的顶视平面图。
图6是图5的检测装置的剖面图。
涉及在检测仪上施加样本的血液葡萄糖检测器是属已知技术，并且以美国Milpitas，CA的LifeScan公司制造的One Touch系列的检测仪为代表。该等检测仪涉及一种浸有一试剂的检测条，此一试剂会因施加在检测条上的全血样本的血液葡萄糖浓度而产生颜色的变化。在实际的操作中，使用者首先将一血液葡萄糖检测条插入检测仪中，然后再将他(她)的血液样本施加在检测条顶表面(样本表面)上的指定区域上。当血液样本穿过检测条到达另一表面(检验表面)时，血液样本中的葡萄糖会与试剂反应以使得检测条检验表面的反射比产生变化。此种反射比的变化与血液样本中的葡萄糖浓度相关。
因为欲作血液葡萄糖检测的糖尿病患者通常患有视觉障碍，他们很难将计刺破手指所流出的血液样本施加至检测条的指定区域上。他们可能会不慎地将其血液沾到检测条指定区域附近的检测仪上。因此，下一位使用者(特别是按医院的惯例，可能是一位不同的使用者)可能会接触到上一位使用者的血液。本发明的装置克服了使用者的血液污染血液葡萄糖检测仪以及使用者被血液葡萄糖检测仪上前一位使用者血液污染的问题。本发明通过设置一护盖而解决这一问题，该护盖固定于检测条上并形成检测条的至少一部分样本接收区的边界，而且在检测条适当定位时覆盖部分的检测仪。上述“形成至少一部分样本接收区的边界”是指护盖与一部分样本接收区邻接，可能(但并不必要)环绕样本接收区。护盖的主要目的是用以避免使用者的血液污染检测仪，而此目的并不需要护盖环绕整个样本接收区来达成。例如，如果通过设置一个与样本接收区对齐的穿孔以使护盖环绕样本接收区，这可帮助使用者将血液样本放置在适当位置中。或者，使用者可另外借助于一个印在护盖上的标记以将样本放置在样本接收区上。此标记可以一图形印在护盖上；例如圆形或其它形式的辅助图案。此护盖是通过环绕穿孔的粘着剂方便地固定在检测条上。如果护盖并没有环绕样本接收区，那样护盖具有一较长的边缘，而沿着此边缘施加粘着剂以在一较大的区域上连接于检测条。虽然任何挠性的片状材质皆可，但由一片透明的挠性塑料切割而成的护盖是为较佳的。有一些已为人所熟知的适用的热塑性材料，例如聚酯、聚碳酸酯、聚苯乙烯等。护盖的厚度并不重要，但通常在是0.05mm至0.2mm的范围内。
图1是一分解透视图，示出了本发明的装置10和一检测仪12。装置10由一检测条14与一护盖16组成。检测条14包含一握持部18和一试剂垫20。护盖16是通过粘着剂22附着至检测条14的握持部18。在使用时，检测条14插入槽道24中，而护盖16覆盖槽道24附近的区域26。
图2是检测装置10装在检测仪12中并随时可让一个血液样本施加至测试条14的样本接收区28时的透视图。样本接收区28是由粘着剂22环绕着。护盖16覆盖与检测仪相邻的区域并防止与检测仪相邻的区域被血液污染。
图3是本发明的装置10的顶视平面图，示出检测条14的握持部18通过粘着剂22附着至护盖16。选择性标记29环绕测试条14的样本接收区28以便帮助使用者找出该区域。
图4是沿图3中装置10的线4-4截取的剖面图。从图4可清楚看出，检测条14的样本接收区28位于试剂垫20的顶表面上。护盖16和握持部18的穿孔30和32在样本接收区28上相互对齐。
图5是本发明的装置的另一实施例的顶视平面图。在此实施例中示出一个具有U型缺口的护盖116。粘着剂122沿着缺口的周缘将护盖116附着至检测条14的握持部118上。
图6是沿图5中的线6-6截取的剖面图。握持部18的孔32与检测条14的样本接收区28重叠，样本接收区28位于试剂垫20的顶表面。
熟悉此技术者应当了解实施例的描述只是为了说明本发明而不具限制性。在不脱离本发明的范围与精神下，本发明可有多种改变。

Claims (4)

1.一种血液葡萄糖监测装置，包括
a.一血液葡萄糖检测条，它通过一槽道插入一血液葡萄糖检测仪的预定位置中，并具有一个可接收血液样本以通过该血液葡萄糖检测仪测量血液样本中葡萄糖浓度的样本接收区；
b.一个护盖，它固定至检测条、形成至少三面样本接收区的边界，并且在检测条就位时覆盖血液葡萄糖检测仪与槽道相邻的一部分；
c.护盖上印有标记用以帮助使用者找出一穿孔。
2.如权利要求1所述的监测装置，其中护盖由一透明的热塑性塑料片材制成。
3.如权利要求1所述的监测装置，其中该穿孔穿过护盖并与样本接收区对齐。
4.如权利要求3所述的监测装置，其中护盖借助于环绕穿孔的粘着剂固定至检测条。
CN97119697A 1996-09-30 1997-09-30 一种血液葡萄糖监测装置 Expired - Fee Related CN1127663C (zh)

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US723,040 1991-06-28
US08/723,040 US5714123A (en) 1996-09-30 1996-09-30 Protective shield for a blood glucose strip
US723040 1996-09-30

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