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    Diagnostic assay for a sample of biological fluid
    1.
    发明授权
    Diagnostic assay for a sample of biological fluid 失效
    生物流体样本的诊断测定

    公开(公告)号：US06312888B1

    公开(公告)日：2001-11-06

    申请号：US09688636

    申请日：2000-10-16

    申请人： Sie Ting Wong ,  Robert G. Hiltibran ,  Tung-Ming Huang ,  Brenda B. Calfin ,  Mark R. Pope ,  Thomas G. Schapira ,  Eric B. Shain ,  Douglas F. Young

    发明人： Sie Ting Wong ,  Robert G. Hiltibran ,  Tung-Ming Huang ,  Brenda B. Calfin ,  Mark R. Pope ,  Thomas G. Schapira ,  Eric B. Shain ,  Douglas F. Young

    IPC分类号： C12Q100

    CPC分类号： G01N33/558 ,  G01N33/525

    摘要： An article and a method for monitoring the concentration of an analyte, e. g., glucose, in blood. In one aspect, the invention involves an article comprising a multiple-layer element. In one embodiment, the article comprises: a multiple-layer element comprising: (a) a base layer (b) a cover layer, the cover layer having a first opening for venting the multiple-layer element and a second opening for receiving a biological sample; and (c) a core layer having a first major surface and a second major surface, the core layer disposed between the base layer and the cover layer, the core layer comprising a sample introduction chamber and a optical reading chamber, the first major surface of the core layer in face-to-face contact with the base layer, the second major surface of the core layer in face-to-face contact with the cover layer. The multiple-layer element of this invention allows the use of samples of blood or other biological fluids, such as interstitial fluid, to provide extremely sensitive assay results. The device has been shown to provide accurate and reproducible results with samples having volumes ranging from about 5 &mgr;L to about 20 &mgr;L. In another aspect, the invention involves a method for using the aforementioned article.

    摘要翻译： 用于监测分析物浓度的文章和方法， 例如血糖中的葡萄糖。 一方面，本发明涉及包含多层元件的制品。 在一个实施例中，所述制品包括：多层元件，包括：（a）基层（b）覆盖层，所述覆盖层具有用于排出所述多层元件的第一开口和用于接收生物 样品; 和（c）具有第一主表面和第二主表面的芯层，所述芯层设置在所述基底层和所述覆盖层之间，所述芯层包括样品引入室和光学读取室，所述芯层的第一主表面 芯层与基层面对面接触，芯层的第二主表面与覆盖层面对面接触。本发明的多层元件允许使用血液样品 或其他生物流体，例如间质液，以提供极敏感的测定结果。 该装置已被证明可以提供具有约5至20微米的体积的样品的准确和可重复的结果。 另一方面，本发明涉及使用上述制品的方法。

    Diagnostic assay requiring a small sample of biological fluid
    4.
    发明授权
    Diagnostic assay requiring a small sample of biological fluid 失效
    诊断测定需要一小部分生物液样品

    公开(公告)号：US6077660A

    公开(公告)日：2000-06-20

    申请号：US095683

    申请日：1998-06-10

    申请人： Sie Ting Wong ,  Robert G. Hiltibran ,  Tung-Ming Huang

    发明人： Sie Ting Wong ,  Robert G. Hiltibran ,  Tung-Ming Huang

    IPC分类号： G01N33/52 ,  C12Q1/32 ,  C12Q1/54 ,  G01N33/53 ,  G01N33/543 ,  G01N33/66 ,  G01N37/00 ,  C12Q1/00 ,  A01N1/02

    CPC分类号： G01N33/54373 ,  G01N33/5304

    摘要： An article and a method for monitoring the concentration of glucose in blood. In one aspect, the invention involves an article comprising a multiple-layer element utilizing reagents capable of reacting with an analyte of interest. In a preferred embodiment, the element comprises:(a) a core layer having two major surfaces, an optical reading chamber extending from a first opening in one of the two major surfaces to a second opening in the other of the two major surfaces, the core layer further having a third opening therein and a flow channel, one end of which flow channel communicates with the third opening and the other end of which flow channel communicates with the optical reading chamber;(b) a base layer in face-to-face contact with one major surface of the core layer; and(c) a cover layer in face-to-face contact with the other major surface of the core layer, the cover layer having an opening therein to vent the element.In another aspect, the invention involves a method comprising the steps of:(a) obtaining a sample of biological fluid, e.g., interstitial fluid, from the body of a patient;(b) introducing the sample to an article comprising a multiple-layer element having an optical reading chamber;(c) allowing reagents to react with an analyte of interest in the sample; and(d) measuring the concentration of analyte in the sample by means of an optical instrument.

    摘要翻译： 一种用于监测血液中葡萄糖浓度的文章和方法。 一方面，本发明涉及一种包含多层元件的制品，该多层元件利用能够与感兴趣的分析物反应的试剂。 在优选实施例中，元件包括：（a）具有两个主表面的芯层，从两个主表面中的一个主表面中的一个中的第一开口延伸到两个主表面中另一个中的第二开口的光学读取室， 芯层还具有第三开口和流动通道，其一端的流动通道与第三开口连通，另一端与光学读取室连通。 （b）与芯层的一个主表面面对面接触的基层; 和（c）与所述芯层的另一个主表面面对面接触的覆盖层，所述覆盖层在其中具有用于排出所述元件的开口。 在另一方面，本发明涉及一种方法，包括以下步骤：（a）从患者的身体获得生物流体样品，例如间质液; （b）将样品引入包含具有光学读取室的多层元件的制品; （c）允许试剂与样品中感兴趣的分析物反应; 和（d）通过光学仪器测量样品中分析物的浓度。

    Method and apparatus for obtaining interstitial fluid for diagnostic tests
    5.
    发明授权
    Method and apparatus for obtaining interstitial fluid for diagnostic tests 失效
    用于诊断测试的获得间质液的方法和装置

    公开(公告)号：US06155992A

    公开(公告)日：2000-12-05

    申请号：US982449

    申请日：1997-12-02

    申请人： Timothy P. Henning ,  Robert G. Hiltibran ,  David D. Cunningham ,  Eric B. Shain ,  Brian J. Tarkowski ,  Douglas F. Young

    发明人： Timothy P. Henning ,  Robert G. Hiltibran ,  David D. Cunningham ,  Eric B. Shain ,  Brian J. Tarkowski ,  Douglas F. Young

    IPC分类号： A61B5/151 ,  A61B5/00 ,  A61B5/1455 ,  A61B5/1477 ,  A61B5/15 ,  A61B10/00

    CPC分类号： A61B5/14514 ,  A61B10/0045 ,  A61B5/14532 ,  A61B2010/008 ,  A61M2037/0007

    摘要： A method and apparatus for obtaining a sample of interstitial fluid from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of (a) treating an area of the skin with vacuum or heat or both vacuum and heat to increase the availability of interstitial fluid at that area of the skin; (b) forming an opening in the treated area of the skin; and (c) extracting the sample of interstitial fluid from the opening in the skin, with the aid of vacuum and stretching of the skin. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. Th apparatus comprises (a) a device for forming an unobstructed opening in the area of the skin from which the sample is to be extracted, preferably a lancing assembly; and (b) a vacuum pump. Preferably, the apparatus also includes a housing.

    摘要翻译： 一种从患者获得间质液样品的方法和装置，用于随后的诊断测试，例如葡萄糖监测。 在本发明的一个方面，该方法包括以下步骤：（a）用真空或热或真空和热处理皮肤区域，以增加皮肤区域间隙液的可用性; （b）在皮肤的处理区域中形成开口; 并且（c）借助真空和皮肤拉伸从皮肤开口提取间质液样品。 在本发明的另一方面，提供一种用于执行前述方法的装置。 Th装置包括（a）用于在要从其中提取样品的皮肤区域中形成无障碍的开口的装置，优选为采血组件; 和（b）真空泵。 优选地，该装置还包括壳体。

    .alpha. hydroxy tripeptide substrates
    6.
    发明授权
    .alpha. hydroxy tripeptide substrates 失效
    α羟基三肽底物

    公开(公告)号：US4244865A

    公开(公告)日：1981-01-13

    申请号：US099376

    申请日：1979-12-03

    申请人： Akhtar Ali ,  Robert G. Hiltibran

    发明人： Akhtar Ali ,  Robert G. Hiltibran

    IPC分类号： G01N33/68 ,  C07K1/113 ,  C07K5/06 ,  C07K5/078 ,  C07K5/08 ,  C12Q1/37 ,  C07C103/52 ,  C07G7/00

    CPC分类号： C07K5/06165 ,  C12Q1/37

    摘要： This invention relates to the synthesis and use of novel .alpha. hydroxy tripeptide substrates which are useful in the quantitative determination of proteolytic enzymes such as thrombin and trypsin. In use, the disclosed substrates are hydrolyzed by a proteolytic enzyme to yield a moiety that can be evaluated spectrophotometrically to indicate the quantity of enzyme present.

    摘要翻译： 本发明涉及可用于蛋白水解酶如凝血酶和胰蛋白酶的定量测定的新型α羟基三肽底物的合成和应用。 在使用中，所公开的底物被蛋白水解酶水解以产生可以通过分光光度法评估以显示酶存在量的部分。