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    Method and apparatus for obtaining blood for diagnostic tests
    1.
    发明授权
    Method and apparatus for obtaining blood for diagnostic tests 有权
    血液检测方法及装置

    公开(公告)号：US06206841B1

    公开(公告)日：2001-03-27

    申请号：US09546948

    申请日：2000-04-11

    申请人： David D. Cunningham ,  Timothy P. Henning ,  Eric B. Shain ,  Douglas F. Young ,  Michael G. Lowery ,  Thomas G. Schapira

    发明人： David D. Cunningham ,  Timothy P. Henning ,  Eric B. Shain ,  Douglas F. Young ,  Michael G. Lowery ,  Thomas G. Schapira

    IPC分类号： A61B500

    CPC分类号： A61B5/15186 ,  A61B5/14532 ,  A61B5/1486 ,  A61B5/150022 ,  A61B5/150068 ,  A61B5/150076 ,  A61B5/150099 ,  A61B5/150221 ,  A61B5/150358 ,  A61B5/150412 ,  A61B5/150503 ,  A61B5/150664 ,  A61B5/15113 ,  A61B5/15125 ,  A61B5/1519 ,  A61B5/15194 ,  A61B5/157 ,  A61B5/411 ,  A61B2562/0295

    摘要： Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and (b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises: (a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and (b) a vacuum pump. Preferably, the apparatus also includes a housing. In another aspect of this invention, an article is provided for an article capable of both collecting blood and detecting an analyte in that blood is provided. The article, which contains an appropriate detection element for determining the amount of analyte in the blood, can be used in conjunction with a meter that measures the signal generated by the detection element of the article. In one embodiment, the article is a multiple-layer element comprising: (a) a layer capable of receiving blood and transporting the blood received by means of chemically aided wicking; (b) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and (c) a layer that can be placed in contact with a meter, the meter-contactable layer overlying the blood-transporting layer, said layer (a) capable of transporting blood to said layer (b).

    摘要翻译： 用于从患者获得血样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，所述方法包括以下步骤：（a）在要从其中提取血液样本的皮肤区域中形成无障碍的开口; 并且（b）借助于皮肤的真空和拉伸，从皮肤中的无障碍的开口提取血液样品。在本发明的另一方面，提供了一种用于执行前述方法的装置。 该装置包括：（a）用于在皮肤区域形成无障碍的开口的装置，所述皮肤区域将从所述皮肤区域中提取所述样品，优选为采血组件; 优选地，该装置还包括壳体。在本发明的另一方面，提供了一种能够收集血液并检测血液中的分析物的物品。 包含用于确定血液中分析物的量的合适的检测元件的物品可以与测量由物品的检测元件产生的信号的计量器结合使用。 在一个实施方案中，制品是多层元件，其包括：（a）能够接收血液并通过化学辅助芯吸输送接收到的血液的层;（b）能够检测分析物的存在或测量 血液中分析物的量; 以及（c）可以与仪表接触的层，覆盖在血液输送层上的可测量接触层，所述层（a）能够将血液输送到所述层（b）。

    Method and apparatus for obtaining blood for diagnostic tests
    2.
    发明授权
    Method and apparatus for obtaining blood for diagnostic tests 失效
    血液检测方法及装置

    公开(公告)号：US6071251A

    公开(公告)日：2000-06-06

    申请号：US982323

    申请日：1997-12-02

    申请人： David D. Cunningham ,  Timothy P. Henning ,  Eric B. Shain ,  Douglas F. Young ,  Michael G. Lowery ,  Thomas G. Schapira

    发明人： David D. Cunningham ,  Timothy P. Henning ,  Eric B. Shain ,  Douglas F. Young ,  Michael G. Lowery ,  Thomas G. Schapira

    IPC分类号： A61B5/151 ,  A61B5/00 ,  A61B5/145 ,  A61B5/1459 ,  A61B5/1473 ,  A61B5/15 ,  A61B5/154 ,  A61B5/157 ,  G01N33/48 ,  G01N33/66

    CPC分类号： A61B5/15186 ,  A61B5/14532 ,  A61B5/1486 ,  A61B5/150022 ,  A61B5/150068 ,  A61B5/150076 ,  A61B5/150099 ,  A61B5/150221 ,  A61B5/150412 ,  A61B5/150503 ,  A61B5/150664 ,  A61B5/15113 ,  A61B5/15125 ,  A61B5/1519 ,  A61B5/15194 ,  A61B5/157 ,  A61B5/411 ,  A61B2562/0295 ,  A61B5/150358

    摘要： Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:(a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and(b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin.In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises:(a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and(b) a vacuum pump.Preferably, the apparatus also includes a housing.In another aspect of this invention, an article is provided for an article capable of both collecting blood and detecting an analyte in that blood is provided. The article, which contains an appropriate detection element for determining the amount of analyte in the blood, can be used in conjunction with a meter that measures the signal generated by the detection element of the article. In one embodiment, the article is a multiple-layer element comprising:(a) a layer capable of receiving blood and transporting the blood received by means of chemically aided wicking;(b) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and(c) a layer that can be placed in contact with a meter, the meter-contactable layer overlying the blood-transporting layer, said layer (a) capable of transporting blood to said layer (b).

    摘要翻译： 用于从患者获得血样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，所述方法包括以下步骤：（a）在要从其中提取血液样本的皮肤区域中形成无障碍的开口; 和（b）借助于真空和皮肤拉伸从皮肤中的无阻塞的开口提取血液样品。 在本发明的另一方面，提供一种用于执行前述方法的装置。 该装置包括：（a）用于在皮肤区域形成无障碍的开口的装置，所述皮肤区域将从所述皮肤区域中提取所述样品，优选为采血组件; 和（b）真空泵。 优选地，该装置还包括壳体。 在本发明的另一方面，提供了一种能够收集血液并检测血液中分析物的物品。 包含用于确定血液中分析物的量的合适的检测元件的物品可以与测量由物品的检测元件产生的信号的计量器结合使用。 在一个实施方案中，制品是多层元件，其包括：（a）能够接收血液并通过化学辅助芯吸运送接收的血液的层; （b）能够检测分析物的存在或测量血液中分析物的量的层; 以及（c）可以与仪表接触的层，覆盖在血液输送层上的可测量接触层，所述层（a）能够将血液输送到所述层（b）。

    Diagnostic assay for a sample of biological fluid
    9.
    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。