公开(公告)号：EP1266609A2

公开(公告)日：2002-12-18

申请号：EP02254052.0

申请日：2002-06-11

申请人： Lifescan, Inc.

发明人： Kiser, Ernest ,  Leong, Koon-Wah

IPC分类号： A61B5/00 ,  A61B5/15

CPC分类号： A61B5/1486 ,  A61B5/14532

摘要： A device for sampling a biological fluid and measuring at least one target constituent within the biological fluid. The device has at least one electrochemical cell having an inner electrode and an outer electrode in a concentrically-spaced relationship. In a preferred embodiment, the outer electrode has a cylindrical configuration having an open distal end and the inner electrode has an elongated configuration positioned co-axially within the outer electrode and a distal end configured to penetrate the skin. The spacing between the electrodes exerts a capillary force on biological fluid present at the open distal end of the outer electrode. A system is also provided which includes a control unit in electrical communication with the electrochemical cell for controlling the selection and measurement of the target constituent. Methods of sampling of biological fluids within the skin and measuring the sampled fluids are also provided, as well as kits comprising one or more of the inventive devices and/or systems.

摘要翻译： 一种用于取样生物流体并测量生物流体内的至少一种目标成分的装置。 该装置具有至少一个电化学电池，该电化学电池具有内部电极和外部电极以同心间隔的关系。 在优选实施例中，外部电极具有一个具有开口远端的圆柱形结构，并且该内部电极具有同轴地位于该外部电极内的细长构型，以及构造成穿透皮肤的远端。 电极之间的间距对存在于外部电极的开放远端的生物流体产生毛细作用力。 还提供一种系统，其包括与电化学电池电连通的控制单元，用于控制目标成分的选择和测量。 还提供了在皮肤内采样生物流体并测量取样的流体的方法，以及包括一个或多个本发明的装置和/或系统的试剂盒。

公开(公告)号：EP2286720B1

公开(公告)日：2014-11-26

申请号：EP10179944.3

申请日：2002-06-11

申请人： LifeScan, Inc.

发明人： Shartle, Robert ,  Leong, Koon-wah ,  Kiser, Ernest

IPC分类号： A61B5/00 ,  A61B5/15

CPC分类号： A61B5/1486 ,  A61B5/14514 ,  A61B5/14532 ,  A61B5/14546 ,  A61B5/150022 ,  A61B5/150282 ,  A61B5/150358 ,  A61B5/150755 ,  A61B5/150984 ,  A61B5/15142 ,  A61B5/15186 ,  A61B5/157 ,  A61B2562/0295 ,  Y10T436/144444

公开(公告)号：EP1598011A3

公开(公告)日：2006-03-01

申请号：EP05076860.5

申请日：2003-05-08

申请人： LifeScan, Inc.

发明人： Yushakov, Vadim ,  McAllister, Devin V. ,  Olson, Lorin ,  Leong, Koon-wah ,  Teodorczyk, Maria ,  Kiser, Ernest

IPC分类号： A61B5/15

CPC分类号： A61B5/14514 ,  A61B5/14532 ,  A61B5/14546 ,  A61B5/150022 ,  A61B5/150213 ,  A61B5/150282 ,  A61B5/150358 ,  A61B5/150419 ,  A61B5/15113 ,  A61B5/15117 ,  A61B5/1519 ,  A61B5/157 ,  A61B2562/0295 ,  A61B2562/12

摘要： Devices, systems and methods are provided for piercing the skin, accessing and collecting physiological sample therein, and measuring a characteristic, e.g. , an analyte concentration, of the sampled physiological sample. The subject devices are in the form of a test strip (2) which includes a biosensor and at least one skin-piercing element (6) which is a planar extension of a portion of the biosensor. At least one fluid pathway (108,128) resides within a portion of the biosensor and within the skin-piercing element. The skin-piercing element has a space-defining configuration therein which acts as a sample fluid pooling area (22,86) upon penetration into the skin. Systems are provided which include one or more test strip devices and a meter (40) for making analyte concentration measurements. Methods for using the devices and systems are also provided.

摘要翻译： 提供了设备，系统和方法，用于刺穿皮肤，进入和收集生理样品，并测量取样的生理样品的特征，例如分析物浓度。 本发明装置是测试条的形式，其包括生物传感器和作为生物传感器的一部分的平面延伸的至少一个皮肤刺穿元件。 至少一个流体通道位于生物传感器的一部分内并且在皮肤刺穿元件内。 皮肤刺穿元件在其中具有空间限定构造，其在穿透到皮肤中时充当样品流体汇集区域。 提供了包括一个或多个测试条装置和用于进行分析物浓度测量的仪表的系统。 还提供了使用装置和系统的方法。

公开(公告)号：EP1360931B1

公开(公告)日：2006-01-04

申请号：EP03252879.6

申请日：2003-05-08

申请人： LifeScan, Inc.

发明人： Yuzhakov, Vadim V. ,  MCallister, Devin V. ,  Olson, Lorin ,  Leong, Koon-wah ,  Teodorczyk, Maria ,  Kiser, Ernest

IPC分类号： A61B5/15

CPC分类号： A61B5/14514 ,  A61B5/14532 ,  A61B5/14546 ,  A61B5/150022 ,  A61B5/150213 ,  A61B5/150282 ,  A61B5/150358 ,  A61B5/150419 ,  A61B5/15113 ,  A61B5/15117 ,  A61B5/1519 ,  A61B5/157 ,  A61B2562/0295 ,  A61B2562/12

公开(公告)号：EP1598011A2

公开(公告)日：2005-11-23

申请号：EP05076860.5

申请日：2003-05-08

申请人： LIFESCAN, INC.

发明人： Yuzhakov, Vadim V. ,  McAllister, Devin V. ,  Olson, Lorin ,  Leong, Koon-wah ,  Teodorczyk, Maria ,  Kiser, Ernest

IPC分类号： A61B5/15

CPC分类号： A61B5/14514 ,  A61B5/14532 ,  A61B5/14546 ,  A61B5/150022 ,  A61B5/150213 ,  A61B5/150282 ,  A61B5/150358 ,  A61B5/150419 ,  A61B5/15113 ,  A61B5/15117 ,  A61B5/1519 ,  A61B5/157 ,  A61B2562/0295 ,  A61B2562/12

摘要： Devices, systems and methods are provided for piercing the skin, accessing and collecting physiological sample therein, and measuring a characteristic, e.g. , an analyte concentration, of the sampled physiological sample. The subject devices are in the form of a test strip (2) which includes a biosensor and at least one skin-piercing element (6) which is a planar extension of a portion of the biosensor. At least one fluid pathway (108,128) resides within a portion of the biosensor and within the skin-piercing element. The skin-piercing element has a space-defining configuration therein which acts as a sample fluid pooling area (22,86) upon penetration into the skin. Systems are provided which include one or more test strip devices and a meter (40) for making analyte concentration measurements. Methods for using the devices and systems are also provided.

摘要翻译： 提供了设备，系统和方法来刺穿皮肤，进入和收集生理样品，并测量其特性，例如， ，样品生理样品的分析物浓度。 本发明装置是测试条（2）的形式，其包括生物传感器和作为生物传感器的一部分的平面延伸的至少一个皮肤刺穿元件（6）。 至少一个流体通道（108,128）位于生物传感器的一部分内并且在皮肤刺穿元件内。 皮肤刺穿元件具有其中的空间限定构造，其在穿透到皮肤中时用作样品流体汇集区域（22,86）。 提供了包括一个或多个测试条装置和用于进行分析物浓度测量的仪表（40）的系统。 还提供了使用装置和系统的方法。

公开(公告)号：EP0852336A1

公开(公告)日：1998-07-08

申请号：EP97310655.2

申请日：1997-12-30

申请人： Lifescan, Inc.

发明人： Douglas, joel ,  Kiser, Ernest ,  Tomasco, Michael F. ,  Dato, Remedios ,  Rice, Edward G. ,  Tuohy, Deborah P. ,  Maxson, Mark ,  Witko, Zbigniew ,  Segelke, Scott

IPC分类号： G01N33/558 ,  C12Q1/54

CPC分类号： G01N33/66 ,  C12Q1/54 ,  G01N33/521 ,  G01N33/523 ,  G01N33/526 ,  G01N33/558

摘要： A multilayer reagent test strip measures the concentration of analyte in a liquid sample that is applied to it. The sample is guided to a number of assay areas arrayed along the strip, where the analyte can react with a reagent to cause a color change. Each assay area also includes an inhibitor for the color-change reaction. The inhibitor concentration increases in successive assay areas; thus, the number of areas that change color is a measure of the analyte concentration. The test strip is particularly adapted for measuring glucose in a whole blood sample. In a preferred embodiment, the sample is guided to the assay areas along a path formed by crushing selected areas of a membrane, and the assay areas are uncrushed areas of the membrane.

摘要翻译： 多层试剂测试条测量施加于其上的液体样品中分析物的浓度。 将样品引导到沿着条带排列的多个测定区域，其中分析物可以与试剂反应以引起颜色变化。 每个测定区域还包括用于变色反应的抑制剂。 连续测定区域的抑制剂浓度增加; 因此，改变颜色的区域的数量是分析物浓度的量度。 测试条特别适用于测量全血样品中的葡萄糖。 在优选的实施方案中，将样品沿着通过破碎膜的选定区域形成的路径被引导到测定区域，并且测定区域是膜的未破碎区域。

公开(公告)号：EP0759555A2

公开(公告)日：1997-02-26

申请号：EP96305720.3

申请日：1996-08-02

申请人： LIFESCAN, INC.

发明人： Douglas, Joel ,  Tomasco, Michael F. ,  Kiser, Ernest ,  Dato, Remedios ,  Rice, Edward G. ,  Tuohy, Deborah P. ,  Maxson, Mark

IPC分类号： G01N33/52

CPC分类号： G01N33/526 ,  C12Q1/54

摘要： A multilayer reagent test strip measures the concentration of analyte in a liquid sample that is applied to it. The sample is guided to a number of assay areas arrayed along the strip, where the analyte can react with a reagent to cause a color change. Each assay area also includes an inhibitor for the color-change reaction. The inhibitor concentration increases in successive assay areas; thus, the number of areas that change color is a measure of the analyte concentration. The test strip is particularly adapted for measuring glucose in a whole blood sample. In a preferred embodiment, the sample is guided to the assay areas along a path formed by crushing selected areas of a membrane, and the assay areas are uncrushed areas of the membrane.

摘要翻译： 多层试剂测试条测量应用于其上的液体样品中分析物的浓度。 将样品引导至沿着条带排列的多个分析区域，其中分析物可以与试剂反应以引起颜色变化。 每个测定区域还包括用于颜色变化反应的抑制剂。 在连续测定区域中抑制剂浓度增加; 因此，改变颜色的区域的数量是分析物浓度的量度。 测试条特别适用于测量全血样品中的葡萄糖。 在一个优选的实施方案中，样品沿着通过压碎膜的选定区域而形成的路径被引导至测定区域，并且测定区域是膜的未压碎区域。