公开(公告)号：US20120199497A1

公开(公告)日：2012-08-09

申请号：US13021956

申请日：2011-02-07

申请人： Zuifang Liu ,  Marco F. Cardosi ,  Christopher Philip Leach ,  Scott Sloss

发明人： Zuifang Liu ,  Marco F. Cardosi ,  Christopher Philip Leach ,  Scott Sloss

IPC分类号： G01N27/26

CPC分类号： G01N27/3272 ,  C12Q1/003 ,  C12Q1/006

摘要： An electrochemical-based analytical test strip for the determination of an analyte (such as glucose) in a bodily fluid sample (e.g., a whole blood sample) includes a substrate, at least one working electrode disposed on the substrate, a sample-soluble enzymatic reagent layer disposed above the working electrode, a diffusion-controlling layer (DCL) disposed between the at least one working electrode and the sample-soluble enzymatic reagent layer; and a sample-receiving chamber. In addition, the sample-soluble enzymatic reagent layer is configured and constituted for operable solubility in a bodily fluid sample applied to the electrochemical-based analytical test strip and received in the sample-receiving chamber and for electrochemical enzymatic reaction with an analyte in the bodily fluid sample. Moreover, the DCL is configured and constituted to provide a predetermined diffusion rate for a component (for example a mediator) of the electrochemical enzymatic reaction through the DCL that is less than the diffusion rate of the component through the bodily fluid sample and for operable hydration by the bodily fluid sample. A method for determining an analyte in a bodily fluid sample includes applying a bodily fluid sample to an electrochemical-based analytical test strip that includes a substrate, at least one working electrode disposed on the substrate, a sample-soluble enzymatic reagent layer disposed above the working electrode, a DCL disposed between the at least one working electrode and the sample-soluble enzymatic reagent layer; and a sample-receiving chamber defined in the electrochemical-based analytical test strip.

摘要翻译： 用于测定体液样品（例如全血样品）中的分析物（例如葡萄糖）的基于电化学的分析测试条包括底物，设置在基底上的至少一个工作电极，样品可溶性酶 设置在所述工作电极上方的试剂层，设置在所述至少一个工作电极和所述样品可溶性酶试剂层之间的扩散控制层（DCL） 和样品接收室。 此外，样品可溶性酶试剂层被构造和构造成用于在施加到基于电化学的分析测试条上的体液样品中的可操作溶解度并且被接收在样品接收室中并且用于与身体中的分析物的电化学酶反应 流体样品。 此外，DCL被配置和构造成通过小于通过体液样品的组分的扩散速率的DCL为电化学酶反应的组分（例如介体）提供预定的扩散速率，并且为了可操作的水合 通过体液样品。 一种用于测定体液样品中的分析物的方法包括将体液样品施加到基于电化学的分析测试条，所述分析测试条包括基底，设置在基底上的至少一个工作电极，设置在基底上的样品可溶性酶试剂层 工作电极，设置在所述至少一个工作电极和所述样品可溶性酶试剂层之间的DCL; 以及在基于电化学的分析测试条中限定的样品接收室。

公开(公告)号：US20110263959A1

公开(公告)日：2011-10-27

申请号：US13178236

申请日：2011-07-07

申请人： Stanley Alan YOUNG ,  David William Taylor ,  Allan Orr ,  Cheryl Neary ,  Nicola Canning ,  Marc Daniel Stern

发明人： Stanley Alan YOUNG ,  David William Taylor ,  Allan Orr ,  Cheryl Neary ,  Nicola Canning ,  Marc Daniel Stern

IPC分类号： A61B5/145

CPC分类号： A61B5/7475 ,  A61B5/14532 ,  G01N33/48785 ,  G06F19/00

摘要： A meter is provided that includes an improved user interface that enables the user to take a specific action, leading them directly to data input options. Such a user interface could be used to input first selected information, such as whether a test was premeal or postmeal, immediately after receiving a result. Optionally, the user interface may include the ability to add an additional comment after inputting the first selected information. Provision of such a user interface would facilitate simpler capture of the first selected information each time the user performs a test, leading to an enhanced understanding of a patient's level of glycemic control. Designing a user interface to enable first selected information to be entered by a user directly after receiving a result is more likely to engage a patient by making it easy and simple to enter important information. This may enable capture of the information thought to be most pertinent e.g. premeal and postmeal information, enhancing the understanding by patients and their carers of the patient's control.

摘要翻译： 提供了一个仪表，其中包括改进的用户界面，使用户能够采取特定的操作，将它们直接引导到数据输入选项。 这样的用户界面可以用于在接收到结果之后立即输入第一选择的信息，例如测试是否是premeal或postmeal。 可选地，用户界面可以包括在输入第一所选择的信息之后添加附加注释的能力。 提供这样的用户界面将有助于每次用户执行测试时更简单地捕获第一选择的信息，从而增强对患者血糖控制水平的理解。 设计用户界面以使用户在接收到结果后直接输入第一选择的信息更有可能通过使输入重要信息变得容易和简单而与患者接触。 这可以使得能够捕获被认为是最相关的信息。 前期和后期信息，增强患者及其护理人员对患者控制的了解。

公开(公告)号：US08025788B2

公开(公告)日：2011-09-27

申请号：US12429376

申请日：2009-04-24

申请人： Marco F. Cardosi ,  Michael O'Connell

发明人： Marco F. Cardosi ,  Michael O'Connell

IPC分类号： G01N33/48 ,  C12Q1/26

CPC分类号： C12Q1/001

摘要： A method for manufacturing an enzymatic reagent ink for use in analytical test strips (such as electrochemical-based analytical test strips configured for the determination of glucose in blood) includes determining a first relationship between wetability of a representative hydrophobic silica material (e.g., a hydrophobic fumed silica material) and at least a first calibration characteristic (for example, a calibration slope) of an analytical test strip that includes an enzymatic reagent ink containing the representative hydrophobic silica material. In the method, the first relationship defines a minimum wetability that provides an acceptable first calibration characteristic. The method also includes determining a second relationship defining wetability of a mixture of a particular hydrophobic silica material and a particular surfactant across a range of relative amount of the particular hydrophobic silica material and the particular surfactant and, subsequently, combining an amount of the particular hydrophobic silica material, an amount of the particular surfactant, and an amount of enzyme (such as glucose oxidase) to form an enzymatic reagent ink. Moreover, the amounts of the particular hydrophobic silica material and the particular surfactant are predetermined based on the second relationship to provide at least the minimum wetability defined by the first relationship.

摘要翻译： 用于制造用于分析试片（例如，用于测定血液中的葡萄糖的基于电化学的分析测试条）的酶试剂油墨的方法包括确定代表性的疏水性二氧化硅材料（例如疏水性的）的可润湿性之间的第一关系 气相二氧化硅材料）和至少包含含有代表性疏水性二氧化硅材料的酶试剂油墨的分析测试条的第一校准特性（例如，校准斜率）。 在该方法中，第一关系定义了提供可接受的第一校准特性的最小可湿性。 该方法还包括确定特定疏水性二氧化硅材料和特定表面活性剂的混合物在特定疏水性二氧化硅材料和特定表面活性剂的相对量的范围内的润湿性的第二关系，并且随后将一定量的特定疏水性 二氧化硅材料，一定量的表面活性剂和一定量的酶（如葡萄糖氧化酶）以形成酶试剂油墨。 此外，特定疏水性二氧化硅材料和特定表面活性剂的量基于第二关系而预先确定，以至少提供由第一关系定义的最小可湿性。

公开(公告)号：US20110189062A1

公开(公告)日：2011-08-04

申请号：US12700555

申请日：2010-02-04

申请人： Marco DeAngeli ,  Luca Valsecchi

发明人： Marco DeAngeli ,  Luca Valsecchi

IPC分类号： G01N33/50 ,  G01N21/01 ,  B65D83/08

CPC分类号： G01N33/48757

摘要： A test strip ejection mechanism, for use with a test strip receiving port and a test strip, includes a framework, an elongated shape memory alloy (SMA) strip (e.g., a SMA wire), a slider, and a heating module. The SMA strip has first and second ends that are attached to the framework and exhibits a solid state transition temperature. The slider is configured to travel along the framework. The heating module is configured to heat the SMA strip from a temperature below the solid state transition temperature to a temperature above the solid state transition temperature. Moreover, the SMA strip and slider are configured such that the slider travels along the framework under an applied force exerted on the slider by the SMA strip as the shape memory strip is heated from a temperature below the solid state transition temperature to a temperature above the solid state temperature by the heating module. In addition, the slider has a proximal end configured to engage a test strip received within a test strip receiving port and eject the test strip from the test strip receiving port as the slider travels along the framework. A test meter for use with a test strip includes a test strip receiving port and a test strip ejection mechanism.

摘要翻译： 用于测试条接收端口和测试条的测试条弹出机构包括框架，细长形状记忆合金（SMA）条（例如SMA线），滑块和加热模块。 SMA带具有连接到框架并具有固态转变温度的第一和第二端。 滑块被配置为沿着框架行进。 加热模块被配置为将SMA条带从低于固态转变温度的温度加热到高于固态转变温度的温度。 此外，SMA条和滑块被构造成使得当形状记忆条被从低于固态转变温度的温度加热到高于固态转变温度的温度时，滑块在由SMA条带施加在滑块上的施加力下沿框架行进 固态温度由加热模块组成。 另外，滑块具有近端，其被配置为接合容纳在测试条接收端口内的测试条，并且当​​滑块沿着框架行进时将测试条从测试条接收端口排出。 用于测试条的测试仪包括测试条接收端口和测试条弹出机构。

公开(公告)号：US20100270151A1

公开(公告)日：2010-10-28

申请号：US12429376

申请日：2009-04-24

申请人： Marco F. CARDOSI ,  Michael O'Connell

发明人： Marco F. CARDOSI ,  Michael O'Connell

IPC分类号： C12Q1/26

CPC分类号： C12Q1/001

摘要： A method for manufacturing an enzymatic reagent ink for use in analytical test strips (such as electrochemical-based analytical test strips configured for the determination of glucose in blood) includes determining a first relationship between wetability of a representative hydrophobic silica material (e.g., a hydrophobic fumed silica material) and at least a first calibration characteristic (for example, a calibration slope) of an analytical test strip that includes an enzymatic reagent ink containing the representative hydrophobic silica material. In the method, the first relationship defines a minimum wetability that provides an acceptable first calibration characteristic. The method also includes determining a second relationship defining wetability of a mixture of a particular hydrophobic silica material and a particular surfactant across a range of relative amount of the particular hydrophobic silica material and the particular surfactant and, subsequently, combining an amount of the particular hydrophobic silica material, an amount of the particular surfactant, and an amount of enzyme (such as glucose oxidase) to form an enzymatic reagent ink. Moreover, the amounts of the particular hydrophobic silica material and the particular surfactant are predetermined based on the second relationship to provide at least the minimum wetability defined by the first relationship.

摘要翻译： 用于制造用于分析试片（例如，用于测定血液中的葡萄糖的基于电化学的分析测试条）的酶试剂油墨的方法包括确定代表性的疏水性二氧化硅材料（例如疏水性的）的可润湿性之间的第一关系 气相二氧化硅材料）和至少包含含有代表性疏水性二氧化硅材料的酶试剂油墨的分析测试条的第一校准特性（例如，校准斜率）。 在该方法中，第一关系定义了提供可接受的第一校准特性的最小可湿性。 该方法还包括确定特定疏水性二氧化硅材料和特定表面活性剂的混合物在特定疏水性二氧化硅材料和特定表面活性剂的相对量的范围内的润湿性的第二关系，并且随后将一定量的特定疏水性 二氧化硅材料，一定量的表面活性剂和一定量的酶（如葡萄糖氧化酶）以形成酶试剂油墨。 此外，特定疏水性二氧化硅材料和特定表面活性剂的量基于第二关系而预先确定，以至少提供由第一关系定义的最小可湿性。

公开(公告)号：US20090302873A1

公开(公告)日：2009-12-10

申请号：US12447475

申请日：2009-08-21

申请人： Barry Haggett ,  Brian Birch ,  Roberto Andres ,  Damian Edward Haydon Baskeyfield

发明人： Barry Haggett ,  Brian Birch ,  Roberto Andres ,  Damian Edward Haydon Baskeyfield

IPC分类号： G01R27/08

CPC分类号： G01N27/3272 ,  Y10T29/49117

摘要： Strips, particularly test strips and adapters for test strips, for use in meters for the electrochemical measurement of analyte in a sample material and in particular the glucose concentration of a sample of blood. The strips comprise a plurality of working connectors, for interfacing with the meter, coupled to one or more working electrodes. The strips are of particular use in adapting multi-input meters for single input use.

摘要翻译： 条带，特别是用于测试条的测试条和适配器，用于在样品材料中的分析物的电化学测量的米中，特别是血液样品的葡萄糖浓度。 条带包括多个工作连接器，用于与仪表接口，耦合到一个或多个工作电极。 这些条带适用于单输入使用的多输入计量表。

公开(公告)号：USD598126S1

公开(公告)日：2009-08-11

申请号：US29319306

申请日：2008-06-06

申请人： Manuel Alvarez-Icaza ,  Lynsey Whyte

设计人： Manuel Alvarez-Icaza ,  Lynsey Whyte

公开(公告)号：US07474390B2

公开(公告)日：2009-01-06

申请号：US11441571

申请日：2006-05-26

申请人： Grenville Arthur Robinson ,  John McInulty ,  Damian Edward Haydon Baskeyfield ,  Thomas J. O'Reilly ,  Anthony J. Cronshaw

发明人： Grenville Arthur Robinson ,  John McInulty ,  Damian Edward Haydon Baskeyfield ,  Thomas J. O'Reilly ,  Anthony J. Cronshaw

IPC分类号： G01N33/48

CPC分类号： G01N33/558 ,  G01N33/66 ,  G01N2021/8488

摘要： A test strip for the determination of an analyte, such as glucose, in a body fluid sample (for example, a whole blood sample) includes a substrate with a working surface for receiving the body fluid sample and a reverse surface that is in opposition to the working surface. The test strip also includes a permutative grey scale calibration pattern disposed on either of the working and reverse surfaces with the permutative grey scale calibration pattern including more than one grey scale region. Moreover, the scale regions of the test strip define a grey scale permutation that uniquely corresponds to a calibration code of the test strip.

摘要翻译： 用于测定体液样品（例如全血样品）中的分析物（例如葡萄糖）的测试条包括具有用于接收体液样品的工作表面的底物和与体液样品相反的反面 工作面。 测试条还包括布置在工作和反面之一上的置换灰度校准图案，其中排列灰度校准图案包括多于一个灰度区域。 此外，测试条的比例区域定义了唯一对应于测试条的校准代码的灰度置换。

公开(公告)号：US07005857B2

公开(公告)日：2006-02-28

申请号：US10432276

申请日：2001-12-19

申请人： Matthias Stiene ,  Tanja Richter ,  Jerome McAleer ,  Elliot Plotkin ,  Manuel Alvarez-Icaza ,  John Allen

发明人： Matthias Stiene ,  Tanja Richter ,  Jerome McAleer ,  Elliot Plotkin ,  Manuel Alvarez-Icaza ,  John Allen

IPC分类号： G01N27/02 ,  G01R27/08

CPC分类号： A61B5/14514 ,  A61B5/1473 ,  A61B5/150022 ,  A61B5/150213 ,  A61B5/150358 ,  A61B5/150419 ,  A61B5/15045 ,  A61B5/150755 ,  A61B5/15142 ,  A61B10/0045 ,  A61B2010/008

摘要： A device and method for measuring clotting times in a fluid, typically blood, within a microchannel, with the onset of clotting being determined by measurement of the rate of change, or the value, of capacitance or impedance between two electrodes situated on either side of the microchannel. The device includes an upper support member and a lower support member with a microchannel formed therein. The device also includes electrodes situated along the length of the microchannel.

摘要翻译： 用于测量微通道内的流体（通常为血液）中的凝血时间的装置和方法，其中凝血的开始是通过测量位于两侧的两个电极之间的变化率或电容或阻抗的值来确定的 微通道。 该装置包括上部支撑构件和具有形成在其中的微通道的下部支撑构件。 该装置还包括沿着微通道的长度设置的电极。

公开(公告)号：US20200271614A1

公开(公告)日：2020-08-27

申请号：US16066133

申请日：2016-12-22

申请人： LifeScan Scotland Limited

发明人： David ELDER ,  David MCCOLL

IPC分类号： G01N27/327

摘要： A hand-held test meter for use with an electro-chemical-based analytical test strip in the determination of an analyte in a bodily fluid sample includes a housing; a strip port connector disposed at least partially within the housing and configured to receive an electro-chemical based analytical test strip; a micro-controller disposed in the housing and configured to generate a micro-controller command signal; an electrode bias drive circuit block disposed in the housing and configured to generate a bias drive signal based on the micro-controller command signal, and a dynamic bias drive adjustment circuit block disposed in the housing and configured to receive at least one sensed electrode voltage and to adjust a bias drive signal from the electrode bias drive circuit block based on the sensed electrode voltage to create an adjusted bias drive signal.