公开(公告)号：US07378007B2

公开(公告)日：2008-05-27

申请号：US10638752

申请日：2003-08-11

Applicant: Piet H. C. Moerman ,  Jerome F. McAleer ,  Matthias Stiene

Inventor： Piet H. C. Moerman ,  Jerome F. McAleer ,  Matthias Stiene

IPC: G01N27/327

CPC classification number: A61B5/1486 ,  A61B5/150022 ,  A61B5/150068 ,  A61B5/150099 ,  A61B5/150198 ,  A61B5/150221 ,  A61B5/150358 ,  A61B5/150412 ,  A61B5/150503 ,  A61B5/150809 ,  A61B5/150824 ,  A61B5/15087 ,  A61B5/150969 ,  A61B5/15113 ,  A61B5/15117 ,  A61B5/15128 ,  A61B5/15153 ,  A61B5/15163 ,  A61B5/157

Abstract: An apparatus for detection and quantitation of an electrochemically-detectable analyte, such as glucose, in blood or interstitial fluid includes a meter unit, a lancet and an electrochemical sensor. Of these components, the meter is preferably reusable, while the lancet and the electrochemical sensor are preferably incorporated in assemblies intended for single-use. The meter unit has a housing, within which a lancet is engaged with a mechanism for moving then lancet; a connector disposed within the housing for engaging an electrochemical sensor specific for the analyte and transmitting a signal indicative of the amount of analyte, and a display operatively-associated with a connector for displaying the amount of the analyte to user. The electrochemical sensor is adapted for detection of a particular analyte. In addition, the electrochemical sensor has an absorptive member for uptake of a sample of blood or interstitial fluid. In one version, the lancet moves from a initial position to a piercing position in which skin of the user is pierced and optionally back to a retracted position. The electrochemical sensor is disposed such that the absorptive member takes up a sample from the pierced skin of the user when it is pierced by the lancet without movement of the apparatus. In an alternative version, the lancet is a hollow cannula through which blood or interstitial fluid is transported from the puncture site to an absorbent portion of the electrochemical sensor. In either version, the apparatus provides single-step operation in which sample acquisition and analysis occur as a result of the single action of pressing the apparatus against the users skin.

Abstract translation: 用于检测和定量血液或组织液中的电化学可检测分析物例如葡萄糖的装置包括仪表单元，刺血针和电化学传感器。 在这些组件中，仪表优选是可重复使用的，而柳叶刀和电化学传感器优选地并入用于单次使用的组件中。 仪表单元具有壳体，其中刺血针与用于移动柳叶刀的机构接合; 连接器，其设置在壳体内，用于接合特定于分析物的电化学传感器，并传输指示分析物量的信号，以及与用于向用户显示分析物的量的连接器可操作地相关联的显示器。 电化学传感器适用于检测特定分析物。 此外，电化学传感器具有用于摄取血液或间质液样品的吸收构件。 在一个版本中，柳叶刀从初始位置移动到刺穿使用者的皮肤的刺穿位置，并且可选地返回到缩回位置。 电化学传感器被布置成使得当刺血针刺穿刺血针而不移动设备时，吸收构件从使用者的穿孔皮肤中吸收样品。 在替代方案中，刺血针是中空套管，血液或间质液通过该中空套管从穿刺部位输送到电化学传感器的吸收部分。 在任一版本中，该装置提供单步操作，其中由于单个动作将装置按压在使用者皮肤上而产生样品采集和分析。

公开(公告)号：US20060001538A1

公开(公告)日：2006-01-05

申请号：US10882642

申请日：2004-06-30

Applicant: Ulrich Kraft ,  Manfred Ebner ,  Matthias Stiene ,  Joseph McCluskey

Inventor： Ulrich Kraft ,  Manfred Ebner ,  Matthias Stiene ,  Joseph McCluskey

IPC: A61B5/00 ,  G08B1/08

CPC classification number: A61B5/0031 ,  A61B5/14532

Abstract: Methods are disclosed for remotely monitoring an analyte concentration of an individual by one or more other individuals.

Abstract translation: 公开了用于远程监测个体由一个或多个其他个体的分析物浓度的方法。

公开(公告)号：US06706159B2

公开(公告)日：2004-03-16

申请号：US09518075

申请日：2000-03-02

Applicant: Piet H. C. Moerman ,  Jerome F. McAleer ,  Matthias Stiene

Inventor： Piet H. C. Moerman ,  Jerome F. McAleer ,  Matthias Stiene

IPC: G01N27327

CPC classification number: A61B5/1486 ,  A61B5/150022 ,  A61B5/150068 ,  A61B5/150099 ,  A61B5/150198 ,  A61B5/150221 ,  A61B5/150358 ,  A61B5/150412 ,  A61B5/150503 ,  A61B5/150809 ,  A61B5/150824 ,  A61B5/15087 ,  A61B5/150969 ,  A61B5/15113 ,  A61B5/15117 ,  A61B5/15128 ,  A61B5/15153 ,  A61B5/15163 ,  A61B5/157

Abstract: An apparatus for detection and quantitation of an electrochemically-detectable analyte, such as glucose, in blood or interstitial fluid includes a meter unit, a lancet and an electrochemical sensor. Of these components, the meter is preferably reusable, while the lancet and the electrochemical sensor are preferably incorporated in assemblies intended for single-use. The meter unit has a housing, within which a lancet is engaged with a mechanism for moving then lancet; a connector disposed within the housing for engaging an electrochemical sensor specific for the analyte and transmitting a signal indicative of the amount of analyte, and a display operatively-associated with a connector for displaying the amount of the analyte to user. The electrochemical sensor is adapted for detection of a particular analyte. In addition, the electrochemical sensor has an absorptive member for uptake of a sample of blood or interstitial fluid. In one version, the lancet moves from a initial position to a piercing position in which skin of the user is pierced and optionally back to a retracted position. The electrochemical sensor is disposed such that the absorptive member takes up a sample from the pierced skin of the user when it is pierced by the lancet without movement of the apparatus. In an alternative version, the lancet is a hollow cannula through which blood or interstitial fluid is transported from the puncture site to an absorbent portion of the electrochemical sensor. In either version, the apparatus provides single-step operation in which sample acquisition and analysis occur as a result of the single action of pressing the apparatus against the users skin.

Abstract translation: 用于检测和定量血液或组织液中的电化学可检测分析物例如葡萄糖的装置包括仪表单元，刺血针和电化学传感器。 在这些组件中，仪表优选是可重复使用的，而柳叶刀和电化学传感器优选地并入用于单次使用的组件中。 仪表单元具有壳体，其中刺血针与用于移动柳叶刀的机构接合; 连接器，其设置在壳体内，用于接合特定于分析物的电化学传感器，并传输指示分析物量的信号，以及与用于向用户显示分析物的量的连接器可操作地相关联的显示器。 电化学传感器适用于检测特定分析物。 此外，电化学传感器具有用于摄取血液或间质液样品的吸收构件。 在一个版本中，柳叶刀从初始位置移动到刺穿使用者的皮肤的刺穿位置，并且可选地返回到缩回位置。 电化学传感器被布置成使得当刺血针刺穿刺血针而不移动设备时，吸收构件从使用者的穿孔皮肤中吸收样品。 在替代方案中，刺血针是中空套管，血液或间质液通过该中空套管从穿刺部位输送到电化学传感器的吸收部分。 在任一版本中，该装置提供单步操作，其中由于单个动作将装置按压在使用者皮肤上而产生样品采集和分析。

公开(公告)号：US07998666B2

公开(公告)日：2011-08-16

申请号：US11659968

申请日：2004-08-13

Applicant: Matthias Stiene ,  Ingrid Rohm

Inventor： Matthias Stiene ,  Ingrid Rohm

IPC: C12Q1/00 ,  G01N15/06 ,  G01N25/08

CPC classification number: C12Q1/006 ,  A61B5/1486 ,  G01N27/3272 ,  G01N33/5438 ,  Y10T156/1036

Abstract: An analyte test element for determining the concentration of at least one analyte in a physiological sample fluid having a first and a second surface in a predetermined distance opposite from each other, said both surfaces are provided with two substantially equivalent patterns forming areas of high and low surface energy which are aligned mostly congruent, whereby the areas with high surface energy create a sample distribution system with at least two detection areas, characterized in that the detection areas of first and second surface are also provided with two corresponding patterns of working and reference electrodes of electrochemical detection means.

Abstract translation: 一种分析物测试元件，用于确定具有彼此相对的预定距离的第一和第二表面的生理样品流体中的至少一种分析物的浓度，所述两个表面设置有两个基本相等的图案，形成高和低的区域 表面能量大致一致地排列，由此具有高表面能的区域产生具有至少两个检测区域的样品分布系统，其特征在于，第一和第二表面的检测区域还设置有两个对应的工作和参考电极图案 的电化学检测装置。

公开(公告)号：US20100140116A1

公开(公告)日：2010-06-10

申请号：US12523020

申请日：2008-01-29

Applicant: Matthias Stiene ,  Eurig Wyn Jones

Inventor： Matthias Stiene ,  Eurig Wyn Jones

IPC: B65D81/26 ,  B65D85/00 ,  B23P19/04

CPC classification number: B65D81/266 ,  G01N33/48778 ,  Y10T29/53

Abstract: A container for moisture sensitive test elements comprising a container body (2, 102, 202), an insert (22, 122, 220) fitting in container body, whereby a cavity (18, 118) is created between outer surface of insert wall (24, 124, 240) and inner surface of container body wall (4, 104, 204), and a lid (50, 150, 250) dimensioned to seal container open end when in a closed position, wherein a desiccant material is contained within the cavity (18, 118) between container body wall and insert wall. Insert wall defines a hollow channel (29, 129, 229) which is dimensioned that at least one test element ex-tents from the insert channel facilitating accessibility to an individual test element for the testing of an analyte of interest. Desiccant material includes an indicator whose colour changes when exposed to moisture indicating to a user whether contents therein, i.e. test elements, have been compromised by environmental factors.

Abstract translation: 一种用于湿气敏感测试元件的容器，包括容器主体（2,102,202），安装在容器主体中的插入件（22,122,220），由此在插入壁的外表面之间形成空腔（18,118） 24，124,240）和容器主体壁（4,104,204）的内表面，以及盖子（50,150,250），其尺寸适于在处于关闭位置时密封容器开口端，其中包含干燥剂材料 容器主体壁和插入壁之间的空腔（18,118）。 插入壁限定了一个中空通道（29,129,209），其尺寸被确定为至少一个测试元件从插入通道出发，便于接近单独的测试元件，以便测试感兴趣的分析物。 干燥剂材料包括当暴露于湿气时其颜色变化的指示器，其指示用户其内容物即测试元件是否已被环境因素所影响。

公开(公告)号：US20070287191A1

公开(公告)日：2007-12-13

申请号：US11659968

申请日：2004-08-13

Applicant: Matthias Stiene ,  Ingrid Rohm

Inventor： Matthias Stiene ,  Ingrid Rohm

IPC: G01N27/00 ,  B01J19/00 ,  B05D1/00

CPC classification number: C12Q1/006 ,  A61B5/1486 ,  G01N27/3272 ,  G01N33/5438 ,  Y10T156/1036

Abstract: An analyte test element for determining the concentration of at least one analyte in a physiological sample fluid having a first and a second surface in a predetermined distance opposite from each other, said both surfaces are provided with two substantially equivalent patterns forming areas of high and low surface energy which are aligned mostly congruent, whereby the areas with high surface energy create a sample distribution system with at least two detection areas, characterized in that the detection areas of first and second surface are also provided with two corresponding patterns of working and reference electrodes of electrochemical detection means.

Abstract translation: 一种分析物测试元件，用于确定具有彼此相对的预定距离的第一和第二表面的生理样品流体中的至少一种分析物的浓度，所述两个表面设置有两个基本相等的图案，形成高和低的区域 表面能量大致一致地排列，由此具有高表面能的区域产生具有至少两个检测区域的样品分布系统，其特征在于，第一和第二表面的检测区域还设置有两个对应的工作和参考电极图案 的电化学检测装置。

公开(公告)号：US20060065532A1

公开(公告)日：2006-03-30

申请号：US10957505

申请日：2004-09-30

Applicant: Matthias Stiene ,  Tanja Richter ,  James Rodgers ,  Margaret MacLennan ,  James Moffat ,  Alan McNeilage

Inventor： Matthias Stiene ,  Tanja Richter ,  James Rodgers ,  Margaret MacLennan ,  James Moffat ,  Alan McNeilage

IPC: B01L3/00 ,  G01N27/447

CPC classification number: B01L3/502707 ,  B01L3/502715 ,  B01L2200/0689 ,  B01L2300/0645 ,  B01L2300/0825 ,  B01L2300/0887 ,  G01N33/48792

Abstract: A microfluidic analytical system for monitoring an analyte (such as glucose) in a fluid sample (e.g., blood or ISF) includes an analysis module and an electrical device (for example, a meter or power supply). The analysis module includes an insulating substrate and a microchannel(s) within the insulating substrate's upper surface. The analysis module also includes a conductive contact pad(s) disposed on the upper surface of the insulating substrate and an electrode(s), with the electrode(s) being disposed over the microchannel. In addition, the analysis module includes an electrically conductive trace(s) that electrically connects the electrode to at least one electrically conductive contact pad. The analysis module also has a laminate layer disposed over the electrode, the electrically conductive trace, the microchannel and a portion of the upper surface of the insulating substrate. The electrically conductive contact pad of the analysis module has an accessible exposed surface for electrical connection to the electrical device.

Abstract translation: 用于监测流体样品（例如血液或ISF）中的分析物（例如葡萄糖）的微流体分析系统包括分析模块和电气装置（例如，仪表或电源）。 分析模块包括绝缘基板和绝缘基板的上表面内的微通道。 分析模块还包括设置在绝缘基板的上表面上的导电接触焊盘和电极，其中电极设置在微通道上。 另外，分析模块包括将电极电连接到至少一个导电接触焊盘的导电迹线。 分析模块还具有设置在电极，导电迹线，微通道和绝缘基板的上表面的一部分上的层压层。 分析模块的导电接触焊盘具有可触及的暴露表面，用于电连接到电气设备。

公开(公告)号：US06990849B2

公开(公告)日：2006-01-31

申请号：US10811446

申请日：2004-03-26

Applicant: Sebastian Bohm ,  James Iain Rodgers ,  Alan McNeilage ,  James Moffat ,  Matthias Stiene ,  Tanja Richter

Inventor： Sebastian Bohm ,  James Iain Rodgers ,  Alan McNeilage ,  James Moffat ,  Matthias Stiene ,  Tanja Richter

IPC: G01N11/00 ,  G01N33/487 ,  G01N15/06 ,  G01N33/00 ,  C12M1/34

CPC classification number: G01N27/3271 ,  A61B5/14532 ,  B01L3/502715 ,  B01L2200/143 ,  B01L2300/0645 ,  B01L2300/0806 ,  B01L2300/0816 ,  B01L2400/0409 ,  G01F1/708 ,  G01F22/00

Abstract: A microfluidic analytical system for monitoring an analyte (for example, glucose) in a liquid sample (e.g., ISF) includes an analysis module with at least one micro-channel for receiving and transporting a liquid sample, at least one analyte sensor for measuring an analyte in the liquid sample and at least one position electrode. The analyte sensor(s) and position electrode(s) are in operative communication with the micro-channel. The microfluidic system also includes a meter configured for measuring an electrical characteristic (such as impedance or resistance) of the position electrode(s). Moreover, the measured electrical characteristic is dependent on the position of the liquid sample in the micro-channel that is in operative communication with the position electrode for which an electrical characteristic is measured.

Abstract translation: 用于监测液体样品（例如，ISF）中的分析物（例如葡萄糖）的微流体分析系统包括具有至少一个用于接收和输送液体样品的微通道的分析模块，至少一个分析物传感器，用于测量 液体样品中的分析物和至少一个位置电极。 分析物传感器和位置电极与微通道可操作地通信。 微流体系统还包括配置用于测量位置电极的电特性（例如阻抗或电阻）的仪表。 此外，所测量的电特性取决于与测量电特性的位置电极可操作地连通的微通道中的液体样品的位置。

公开(公告)号：US20060001551A1

公开(公告)日：2006-01-05

申请号：US10883003

申请日：2004-06-30

Applicant: Ulrich Kraft ,  Manfred Ebner ,  Matthias Stiene ,  Joseph McCluskey

Inventor： Ulrich Kraft ,  Manfred Ebner ,  Matthias Stiene ,  Joseph McCluskey

IPC: G08B21/00 ,  A61B5/00 ,  G08B1/08

CPC classification number: A61B5/0031 ,  A61B5/14532

Abstract: Systems are disclosed for remotely monitoring an analyte concentration of an individual by one or more other individuals.

Abstract translation: 公开了用于由一个或多个其他个体远程监测个体的分析物浓度的系统。

公开(公告)号：US20050113739A1

公开(公告)日：2005-05-26

申请号：US10718818

申请日：2003-11-21

Applicant: Matthias Stiene ,  Michael Hilgers ,  Tanja Richter

Inventor： Matthias Stiene ,  Michael Hilgers ,  Tanja Richter

IPC: A61B5/00 ,  A61B5/145 ,  A61B5/15 ,  A61B5/151 ,  A61B5/157 ,  A61B17/20 ,  A61M1/00

CPC classification number: A61B5/15117 ,  A61B5/150022 ,  A61B5/150282 ,  A61B5/150396 ,  A61B5/150511 ,  A61B5/150526 ,  A61B5/15087 ,  A61B5/15107 ,  A61B5/1519

Abstract: A device for extracting bodily fluid (such as an ISF sample) includes a penetration member with a channel (e.g., a hollow needle) and a fluid flow regulator (for example, a narrow-bore cylinder) disposed within the channel. The penetration member is configured for penetrating a target site (such as a dermal tissue target site) and subsequently residing within the target site and extracting a bodily fluid sample therefrom. The fluid flow regulator is adapted to control (e.g., reduce or minimize variation in) bodily fluid flow rate through the penetration member. In addition, the presence of the fluid flow regulator in the channel of the penetration member serves to reduce sensor lag by reducing the dead volume of the penetration member. A method for extracting bodily fluid from a target site includes providing the aforementioned device. Next, the target site is penetrated with the penetration member of the device. Subsequently, bodily fluid is extracted from the target site via the penetration member and the fluid flow regulator of the device.

Abstract translation: 用于提取体液（例如ISF样品）的装置包括具有通道（例如空心针）的穿透构件和设置在通道内的流体流量调节器（例如，窄孔缸）。 穿透构件被构造成用于穿透靶部位（例如真皮组织靶位点）并随后驻留在靶位点内并从其中提取体液样品。 流体流量调节器适于通过穿透构件控制（例如，减小或最小化）体液流速的变化。 此外，流体流量调节器在穿透构件的通道中的存在用于通过减少穿透构件的死体积来减小传感​​器滞后。 从目标部位提取体液的方法包括提供上述装置。 接下来，目标部位用装置的穿透部件穿透。 随后，通过穿透构件和装置的流体流动调节器从目标部位提取体液。