公开(公告)号：US20100190268A1

公开(公告)日：2010-07-29

申请号：US12713066

申请日：2010-02-25

申请人： Arvind N. Jina

发明人： Arvind N. Jina

IPC分类号： G01N33/558

CPC分类号： G01N33/723 ,  G01N33/558 ,  G01N33/721 ,  Y10S436/805 ,  Y10S436/808 ,  Y10S436/81

摘要： A system for treating a blood sample (700) having an analyte of interest comprises a strip (200) having a membrane (218), respective portions (216, 220 and 222, or 300) which are provided for receiving the sample, for lysing cells of the sample to liberate hemoglobin, and for capturing glycated hemoglobin. The latter two portions (220 and 222, or 300) of the membrane are treated with lysing and capture agents, respectively. A portion of the strip (214 or 230 or 240) is provided for holding an eluting agent and for releasing the agent upon a release condition. A system for detecting analyte comprises an optical subsystem (550) that is aligned with the strip to provide a signal corresponding to an amount of analyte, and an electronic subsystem (650) for processing the signal (560) to provide a result, such as an amount or percentage of glycated hemoglobin. To use these systems, the user simply applies a small sample (700) to the membrane (218) and closes a door (10) of the detection system over the strip (200) such that the door triggers the release of the eluting agent. No sample pre-treatment is required. The preferably handheld system (100) is a simple and convenient monitoring tool for the user, such as a diabetic patient who must monitor blood glucose on an on-going basis. While the systems are useful in the monitoring of blood glucose, they may be used for treating a sample other than blood and detecting an analyte other than an analyte in blood.

摘要翻译： 用于处理具有感兴趣分析物的血液样品（700）的系统包括具有膜（218）的条带（200），被设置用于接收样品的相应部分（216,220和222或300），用于裂解 样品的细胞释放血红蛋白，并用于捕获糖化血红蛋白。 膜的后两部分（220和222或300）分别用裂解和捕获剂处理。 提供条带（214或230或240）的一部分用于容纳洗脱剂并在释放条件下释放该药剂。 用于检测分析物的系统包括光学子系统（550），其与条带对准以提供对应于分析物的量的信号;以及电子子系统（650），用于处理信号（560）以提供结果，例如 糖化血红蛋白的量或百分数。 为了使用这些系统，用户简单地将小样品（700）施加到膜（218）并且关闭带（200）上的检测系统的门（10），使得门触发洗脱剂的释放。 不需要样品预处理。 优选的手持系统（100）是用于用户的简单和方便的监测工具，例如必须一直监测血糖的糖尿病患者。 虽然这些系统可用于监测血糖，但它们可用于治疗血液以外的样品，并检测血液中的分析物以外的分析物。

公开(公告)号：US6046051A

公开(公告)日：2000-04-04

申请号：US884027

申请日：1997-06-27

申请人： Arvind N. Jina

发明人： Arvind N. Jina

IPC分类号： G01N33/49 ,  G01N33/86

CPC分类号： G01N33/86 ,  G01N33/4905

摘要： The present invention provides a single-use electronic device and test card for use therein which performs a coagulation or lysis assay of a blood sample. The device includes a housing having an exterior surface and defining an interior area and means for receiving the sample through the housing into the interior space. A non-porous substrate is positioned within the interior space for receiving the sample thereon. A reagent accelerates the coagulation of the sample and is positioned on the substrate and in contact with the sample. Optionally, an electroactive species may also be reacted with the sample. The device also includes means for measuring the viscosity of the sample and generating an electrical signal which correlates to a curve of the coagulation/lysis assay. Processing means positioned within the interior space is connected to the measuring means for receiving and converting the electrical signal into a digital output corresponding to the coagulation/lysis assay using assay calibration information stored therein. Display means visually displays the digital output external to the housing and is connected to the processing means. A method of determining the coagulation or lysis of a sample provides for accelerating the coagulation of the sample by chemically reacting the sample with at least one reagent on the substrate to produce a detectable change in the viscosity of the sample which correlates with the state of coagulation or lysis of the sample and measuring the viscosity of the sample and generating an electrical signal which correlates to a curve of the coagulation/lysis assay.

公开(公告)号：US20120172692A1

公开(公告)日：2012-07-05

申请号：US12985224

申请日：2011-01-05

申请人： Janet Tamada ,  Michael J. Tierney ,  Ramakrishna Madabhushi ,  Arvind N. Jina

发明人： Janet Tamada ,  Michael J. Tierney ,  Ramakrishna Madabhushi ,  Arvind N. Jina

IPC分类号： A61B5/1486

CPC分类号： A61B5/14514 ,  A61B5/14532 ,  A61B5/14865 ,  A61B5/685

摘要： An analyte monitor having a plurality of fluid paths, each fluid path having a distal opening adapted to be disposed on one side of a stratum corneum layer of a user's skin, a proximal opening adapted to be disposed on another side of the stratum corneum layer and an interior space extending between the distal and proximal openings; a sensing zone in fluid communication with the proximal openings of the fluid paths; sensing fluid extending from the sensing zone into substantially the entire interior space of the fluid paths; and an analyte sensor adapted to detect a concentration of analyte in the sensing fluid within the sensing zone, wherein at least one of the sensing fluid and the analyte sensor comprises a catalyst for mutarotation of glucose. The invention also includes a method of using the monitor.

摘要翻译： 一种具有多个流体路径的分析物监测器，每个流体路径具有适于设置在使用者皮肤的角质层的一侧上的远端开口，适于设置在角质层的另一侧上的近侧开口，以及 在远端和近端开口之间延伸的内部空间; 与流体路径的近端开口流体连通的感测区域; 从所述感测区域延伸到所述流体路径的基本上整个内部空间中的感测流体; 以及分析物传感器，其适于检测所述感测区域内的所述感测流体中的分析物的浓度，其中所述感测流体和所述分析物传感器中的至少一个包括用于葡萄糖变异的催化剂。 本发明还包括使用监视器的方法。

公开(公告)号：US20100049021A1

公开(公告)日：2010-02-25

申请号：US12545008

申请日：2009-08-20

申请人： Arvind N. Jina ,  Ashok Parmar ,  Beelee Chua ,  Janet Tamada ,  Jonathan Lee ,  Michael J. Tierney ,  Navneet Kaur ,  Paul Magginetti ,  Shashi P. Desai

发明人： Arvind N. Jina ,  Ashok Parmar ,  Beelee Chua ,  Janet Tamada ,  Jonathan Lee ,  Michael J. Tierney ,  Navneet Kaur ,  Paul Magginetti ,  Shashi P. Desai

IPC分类号： A61B5/1468

CPC分类号： A61B5/14532 ,  A61B5/14514 ,  A61B5/14865 ,  A61B2560/0223

摘要： One aspect of the invention provides an analyte monitor including a sensing volume, an analyte extraction area in contact with the sensing volume adapted to extract an analyte into the sensing volume, and an analyte sensor adapted to detect a concentration of analyte in the sensing volume. The sensing volume is defined by a first face, a second face opposite to the first face, and a thickness equal to the distance between the two faces. The surface area of the first face is about equal to the surface area of the second face and the extraction area is about equal to the surface area of the first and second face of the sensing volume. The analyte sensor includes a working electrode in contact with the sensing volume, the working electrode having a surface area at least as large as the analyte extraction area, and a second electrode in fluid communication with the sensing volume.

摘要翻译： 本发明的一个方面提供一种分析物监测器，其包括感测体积，与适于将分析物提取到感测体积中的感测体接触的分析物提取区域，以及适于检测感测体积中的分析物浓度的分析物传感器。 感测体积由第一面，与第一面相反的第二面和厚度等于两个面之间的距离限定。 第一面的表面积约等于第二面的表面积，并且提取面积大约等于感测体积的第一和第二面的表面积。 分析物传感器包括与感测体积接触的工作电极，工作电极具有至少与分析物提取区域一样大的表面积，以及与感测体积流体连通的第二电极。

公开(公告)号：US20080312518A1

公开(公告)日：2008-12-18

申请号：US11763414

申请日：2007-06-14

申请人： Arvind N. Jina ,  Beelee Chua ,  Shashi P. Desai ,  Abdel-Nasser Kawde

发明人： Arvind N. Jina ,  Beelee Chua ,  Shashi P. Desai ,  Abdel-Nasser Kawde

IPC分类号： A61B5/00

CPC分类号： A61B5/1495 ,  A61B5/0002 ,  A61B5/14514 ,  A61B5/14532 ,  A61B5/14546 ,  A61B5/14865

摘要： An analyte monitor is provided with a sensor unit body configured for mounting on tissue, a sensor configured to detect an analyte in a fluid in the sensing area, an output device configured to communicate a result from the sensor to a user; and a user input device coupled with the sensor and the output device, wherein the monitor is configured to communicate a result to the user through the output device only after the user input device is activated. Systems, sensors and methods associated with the monitor are also disclosed.

摘要翻译： 分析物监视器设置有被配置为安装在组织上的传感器单元主体，被配置为检测感测区域中的流体中的分析物的传感器，被配置为将来自传感器的结果传达给用户的输出设备; 以及与传感器和输出设备耦合的用户输入设备，其中监视器被配置为仅在用户输入设备被激活之后通过输出设备将结果传达给用户。 还公开了与监视器相关联的系统，传感器和方法。

公开(公告)号：US06338821B1

公开(公告)日：2002-01-15

申请号：US09542886

申请日：2000-04-04

申请人： Arvind N. Jina

发明人： Arvind N. Jina

IPC分类号： G01N3386

CPC分类号： G01N33/86 ,  G01N33/4905

摘要： The present invention provides a single-use electronic device and test card for use therein which performs a coagulation or lysis assay of a blood sample. The device includes a housing having an exterior surface and defining an interior area and means for receiving the sample through the housing into the interior space. A non-porous substrate is positioned within the interior space for receiving the sample thereon. A reagent accelerates the coagulation of the sample and is positioned on the substrate and in contact with the sample. Optionally, an electroactive species may also be reacted with the sample. The device also includes means for measuring the viscosity of the sample and generating an electrical signal which correlates to a curve of the coagulation/lysis assay. Processing means positioned within the interior space is connected to the measuring means for receiving and converting the electrical signal into a digital output corresponding to the coagulation/lysis assay using assay calibration information stored therein. Display means visually displays the digital output external to the housing and is connected to the processing means. A method of determining the coagulation or lysis of a sample provides for accelerating the coagulation of the sample by chemically reacting the sample with at least one reagent on the substrate to produce a detectable change in the viscosity of the sample which correlates with the state of coagulation or lysis of the sample and measuring the viscosity of the sample and generating an electrical signal which correlates to a curve of the coagulation/lysis assay.

摘要翻译： 本发明提供一种用于其中的一次性电子装置和测试卡，其执行血液样品的凝固或裂解测定。 该装置包括具有外表面并限定内部区域的壳体和用于通过壳体将样品接收到内部空间中的装置。 无孔基材位于内部空间内用于在其上接收样品。 试剂加速了样品的凝固，并且定位在基底上并与样品接触。 任选地，电活性物质也可以与样品反应。 该装置还包括用于测量样品的粘度并产生与凝血/裂解测定曲线相关的电信号的装置。 位于内部空间内的处理装置连接到测量装置，用于使用存储在其中的测定校准信息，将电信号接收并转换成对应于凝固/裂解测定的数字输出。 显示装置可视地显示外壳外部的数字输出并连接到处理装置。 确定样品的凝固或裂解的方法提供了通过使样品与基底上的至少一种试剂化学反应来加速样品的凝固，以产生与凝固状态相关的样品粘度的可检测变化 或裂解样品并测量样品的粘度并产生与凝固/裂解测定曲线相关的电信号。

公开(公告)号：US08280476B2

公开(公告)日：2012-10-02

申请号：US11277731

申请日：2006-03-28

申请人： Arvind N. Jina

发明人： Arvind N. Jina

IPC分类号： A61B5/05

CPC分类号： A61B5/14532 ,  A61B5/14514 ,  A61B5/14865

摘要： One aspect of the invention provides a glucose monitor having a plurality of tissue piercing elements, each tissue piercing element having a distal opening, a proximal opening and interior space extending between the distal and proximal openings; a sensing area in fluid communication with the proximal openings of the tissue piercing elements; sensing fluid extending from the sensing area into substantially the entire interior space of the tissue piercing elements; and a glucose sensor adapted to detect a concentration of glucose in the sensing fluid within the sensing area. Another aspect of the invention provides a method of in vivo monitoring of an individual's interstitial fluid glucose concentration including the following steps: inserting distal ends of a plurality of tissue piercing elements through a stratum corneum area of the individual's skin, the tissue piercing elements each having a distal opening, a proximal opening, an interior space extending between the distal and proximal openings, and a sensing fluid filling substantially the entire interior space; and sensing a glucose concentration of the sensing fluid.

摘要翻译： 本发明的一个方面提供一种具有多个组织刺穿元件的葡萄糖监测器，每个组织刺穿元件具有远端开口，在远端和近端开口之间延伸的近端开口和内部空间; 与组织刺穿元件的近端开口流体连通的感测区域; 感测从所述感测区域延伸到所述组织刺穿元件的大致整个内部空间的流体; 以及适于检测感测区域内的感测流体中的葡萄糖浓度的葡萄糖传感器。 本发明的另一方面提供一种体内监测个体间质液葡萄糖浓度的方法，包括以下步骤：将多个组织刺穿元件的远端插入穿过个体皮肤的角质层区域，每个组织刺穿元件具有 远端开口，近端开口，在远端和近端开口之间延伸的内部空间，以及基本上填充整个内部空间的感测流体; 并感测感测流体的葡萄糖浓度。

公开(公告)号：US20080154107A1

公开(公告)日：2008-06-26

申请号：US11642196

申请日：2006-12-20

申请人： Arvind N. Jina

发明人： Arvind N. Jina

IPC分类号： A61B5/145

CPC分类号： A61B5/14532 ,  A61B5/14514 ,  A61B5/14865

摘要： The present invention includes methods and apparatus for continuous glucose monitoring of a patient. In one aspect a glucose monitor includes a plurality of substantially cylindrical tissue piercing elements adapted to pierce the stratum corneum and enter the epidermis, allowing for the diffusion of glucose from the interstitial fluid into the glucose monitors described herein. In another aspect of the invention, a glucose monitor includes a deformed substrate layer defining a plurality of tissue piercing elements.

摘要翻译： 本发明包括用于患者的连续葡萄糖监测的方法和装置。 在一个方面，葡萄糖监测器包括多个基本上圆柱形的组织刺穿元件，其适于刺穿角质层并进入表皮，允许将葡萄糖从间质液扩散到本文所述的葡萄糖监测器中。 在本发明的另一方面，葡萄糖监测器包括限定多个组织刺穿元件的变形的基底层。

公开(公告)号：US6066504A

公开(公告)日：2000-05-23

申请号：US231731

申请日：1999-01-15

申请人： Arvind N. Jina

发明人： Arvind N. Jina

IPC分类号： G01N33/49 ,  G01N33/86

CPC分类号： G01N33/86 ,  G01N33/4905

摘要： The present invention provides a single-use electronic device and test card for use therein which performs a coagulation or lysis assay of a blood sample. The device includes a housing having an exterior surface and defining an interior area and means for receiving the sample through the housing into the interior space. A non-porous substrate is positioned within the interior space for receiving the sample thereon. A reagent accelerates the coagulation of the sample and is positioned on the substrate and in contact with the sample. Optionally, an electroactive species may also be reacted with the sample. The device also includes means for measuring the viscosity of the sample and generating an electrical signal which correlates to a curve of the coagulation/lysis assay. Processing means positioned within the interior space is connected to the measuring means for receiving and converting the electrical signal into a digital output corresponding to the coagulation/lysis assay using assay calibration information stored therein. Display means visually displays the digital output external to the housing and is connected to the processing means. A method of determining the coagulation or lysis of a sample provides for accelerating the coagulation of the sample by chemically reacting the sample with at least one reagent on the substrate to produce a detectable change in the viscosity of the sample which correlates with the state of coagulation or lysis of the sample and measuring the viscosity of the sample and generating an electrical signal which correlates to a curve of the coagulation/lysis assay.

摘要翻译： 本发明提供一种用于其中的一次性电子装置和测试卡，其执行血液样品的凝固或裂解测定。 该装置包括具有外表面并限定内部区域的壳体和用于通过壳体将样品接收到内部空间中的装置。 无孔基材位于内部空间内用于在其上接收样品。 试剂加速了样品的凝固，并且定位在基底上并与样品接触。 任选地，电活性物质也可以与样品反应。 该装置还包括用于测量样品的粘度并产生与凝血/裂解测定曲线相关的电信号的装置。 位于内部空间内的处理装置连接到测量装置，用于使用存储在其中的测定校准信息，将电信号接收并转换成对应于凝固/裂解测定的数字输出。 显示装置可视地显示外壳外部的数字输出并连接到处理装置。 确定样品的凝固或裂解的方法提供了通过使样品与基底上的至少一种试剂化学反应来加速样品的凝固，以产生与凝固状态相关的样品粘度的可检测变化 或裂解样品并测量样品的粘度并产生与凝固/裂解测定曲线相关的电信号。

公开(公告)号：US6060323A

公开(公告)日：2000-05-09

申请号：US195842

申请日：1998-11-19

申请人： Arvind N. Jina

发明人： Arvind N. Jina

IPC分类号： G01N33/49 ,  G01N33/86

CPC分类号： G01N33/86 ,  G01N33/4905

摘要： The present invention provides a single-use electronic device and test card for use therein which performs a coagulation or lysis assay of a blood sample. The device includes a housing having an exterior surface and defining an interior area and means for receiving the sample through the housing into the interior space. A non-porous substrate is positioned within the interior space for receiving the sample thereon. A reagent accelerates the coagulation of the sample and is positioned on the substrate and in contact with the sample. Optionally, an electroactive species may also be reacted with the sample. The device also includes means for measuring the viscosity of the sample and generating an electrical signal which correlates to a curve of the coagulation/lysis assay. Processing means positioned within the interior space is connected to the measuring means for receiving and converting the electrical signal into a digital output corresponding to the coagulation/lysis assay using assay calibration information stored therein. Display means visually displays the digital output external to the housing and is connected to the processing means. A method of determining the coagulation or lysis of a sample provides for accelerating the coagulation of the sample by chemically reacting the sample with at least one reagent on the substrate to produce a detectable change in the viscosity of the sample which correlates with the state of coagulation or lysis of the sample and measuring the viscosity of the sample and generating an electrical signal which correlates to a curve of the coagulation/lysis assay.