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    Method for optical measurements of tissue to determine disease state or concentration of an analyte
    3.
    发明授权
    Method for optical measurements of tissue to determine disease state or concentration of an analyte 有权
    用于光学测量组织以确定分析物的疾病状态或浓度的方法

    公开(公告)号：US07167734B2

    公开(公告)日：2007-01-23

    申请号：US09834440

    申请日：2001-04-13

    申请人： Omar S. Khalil ,  Shu-jen Yeh ,  Stanislaw Kantor ,  Charles F. Hanna ,  Eric B. Shain

    发明人： Omar S. Khalil ,  Shu-jen Yeh ,  Stanislaw Kantor ,  Charles F. Hanna ,  Eric B. Shain

    IPC分类号： A61B5/00

    CPC分类号： A61B5/1495 ,  A61B5/14532 ,  A61B5/1455 ,  A61B5/7264

    摘要： A method for collecting optical data at two morphologically similar, substantially non-overlapping, and preferably adjacent, areas on the surface of a tissue, while the temperature in each area is being maintained or modulated according to a temperature program. The optical data obtained are inserted into a mathematical relationship, e.g., an algorithm, that can be used to predict a disease state (such as the diabetes mellitus disease state) or the concentration of an analyte for indicating a physical condition (such as blood glucose level). This invention can be used to differentiate between disease status, such as, for example, diabetic and non-diabetic. The method involves the generation of a calibration (or training) set that utilizes the relationship between optical signals emanating from the skin under different thermal stimuli and disease status, e.g., diabetic status, established clinically. This calibration set can be used to predict the disease state of other subjects. Structural changes, as well as circulatory changes, due to a disease state are determined at two morphologically similar, but substantially non-overlapping areas on the surface of human tissue, e.g., the skin of a forearm, with each area being subjected to different temperature modulation programs. In addition to determination of a disease state, this invention can also be used to determine the concentration of an analyte in the tissues. This invention also provides an apparatus for the determination of a disease state, such as diabetes, or concentration of an analyte, such as blood glucose level, by the method of this invention.

    摘要翻译： 一种用于在组织表面上的两个形态上类似的，基本上不重叠的，优选相邻的区域收集光学数据的方法，同时根据温度程序维持或调节每个区域中的温度。 所获得的光学数据被插入到数学关系中，例如算法，其可用于预测疾病状态（例如糖尿病状态）或用于指示身体状况的分析物的浓度（例如血糖 水平）。 本发明可用于区分疾病状况，例如糖尿病和非糖尿病。 该方法包括产生校准（或训练）组，其利用在不同热刺激下发生的光学信号与疾病状态（例如临床确立的糖尿病状态）之间的关系。 该校准集可用于预测其他受试者的疾病状态。 由于疾病状态引起的结构变化以及循环变化在人组织表面上的两个形态相似但基本上非重叠的区域确定，例如前臂的皮肤，每个区域经受不同的温度 调制程序。 除了确定疾病状态之外，本发明还可以用于确定组织中分析物的浓度。 本发明还提供了一种用于通过本发明的方法测定疾病状态的装置，例如糖尿病或分析物的浓度，例如血糖水平。

    Reagentless analysis of biological samples
    4.
    发明授权
    Reagentless analysis of biological samples 有权
    对生物样品进行无谓分析

    公开(公告)号：US06773922B2

    公开(公告)日：2004-08-10

    申请号：US10191148

    申请日：2002-07-09

    申请人： Tzyy-Wen Jeng ,  Larry L. McDowell ,  Joseph Larry Pezzaniti ,  Gary M. Oosta ,  Eric B. Shain

    发明人： Tzyy-Wen Jeng ,  Larry L. McDowell ,  Joseph Larry Pezzaniti ,  Gary M. Oosta ,  Eric B. Shain

    IPC分类号： G01N2141

    CPC分类号： G01N21/4133 ,  G01N21/05 ,  G01N21/274 ,  Y10T436/144444 ,  Y10T436/146666 ,  Y10T436/147777 ,  Y10T436/171538 ,  Y10T436/200833

    摘要： Apparatus and method for determining at least one parameter, e.g., concentration, of at least one analyte, e.g., urea, of a biological sample, e.g., urine. A biological sample particularly suitable for the apparatus and method of this invention is urine. In general, spectroscopic measurements can be used to quantify the concentrations of one or more analytes in a biological sample. In order to obtain concentration values of certain analytes, such as hemoglobin and bilirubin, visible light absorption spectroscopy can be used. In order to obtain concentration values of other analytes, such as urea, creatinine, glucose, ketones, and protein, infrared light absorption spectroscopy can be used. The apparatus and method of this invention utilize one or more mathematical techniques to improve the accuracy of measurement of parameters of analytes in a biological sample. The invention also provides an apparatus and method for measuring the refractive index of a sample of biological fluid while making spectroscopic measurements substantially simultaneously.

    摘要翻译： 用于确定生物样品例如尿液的至少一种分析物（例如尿素）的至少一个参数例如浓度的装置和方法。 特别适用于本发明的装置和方法的生物样品是尿液。 通常，光谱测量可用于量化生物样品中一种或多种分析物的浓度。 为了获得某些分析物（如血红蛋白和胆红素）的浓度值，可以使用可见光吸收光谱。 为了获得其他分析物（如尿素，肌酐，葡萄糖，酮和蛋白质）的浓度值，可以使用红外光吸收光谱。 本发明的装置和方法利用一种或多种数学技术来提高生物样品中分析物参数的测量精度。 本发明还提供了一种用于在基本上同时进行光谱测量的同时测量生物流体样品的折射率的装置和方法。

    Method and apparatus for obtaining biological fluids
    9.
    发明授权
    Method and apparatus for obtaining biological fluids 失效
    用于获得生物流体的方法和装置

    公开(公告)号：US5913833A

    公开(公告)日：1999-06-22

    申请号：US798403

    申请日：1997-02-07

    申请人： Tuan A. Elstrom ,  Eric B. Shain

    发明人： Tuan A. Elstrom ,  Eric B. Shain

    IPC分类号： A61B5/00 ,  A61B5/15 ,  A61B10/00 ,  A61M37/00

    CPC分类号： A61B5/14514 ,  A61B5/150022 ,  A61B5/150083 ,  A61B5/150343 ,  A61B5/150412 ,  A61B5/150748 ,  A61B5/150755 ,  A61B5/15107 ,  A61B5/15121 ,  A61B5/15186 ,  A61M37/0092 ,  A61B2010/008 ,  A61B5/14532 ,  A61M2037/0007

    摘要： This invention provides a method and apparatus for disrupting the outermost layer of skin, the stratum corneum, to provide access to biological fluid, which can then be used to determine the concentration of glucose in blood. The invention can be used to extract interstitial fluid, blood, and mixtures of interstitial fluid and blood from the body of a human or an animal.The method comprises the steps of (1) attaching a receptacle for collecting biological fluid to the surface of the skin of a patient, (2) introducing an oscillation concentrator attached to an oscillation element into the receptacle, (3) positioning the oscillation concentrator at a desired distance from the surface of the skin, (4) activating the oscillation element to transversely oscillate the attached oscillation concentrator, (5) collecting the biological fluid after a specific period of time, and (6) analyzing the biological fluid for the presence of an analyte.

    摘要翻译： 本发明提供了一种用于破坏皮肤最外层（角质层）的方法和装置，以提供对生物流体的通路，然后可以将其用于确定血液中葡萄糖的浓度。 本发明可用于从人或动物体内提取间质液，血液，以及间质液和血液的混合物。 该方法包括以下步骤：（1）将用于收集生物流体的容器附接到患者皮肤表面，（2）将安装在振动元件上的振动聚集器引入到容器中，（3）将振荡集中器定位在 距离皮肤表面的期望距离，（4）激活振荡元件以使所连接的振荡聚集器横向振荡，（5）在特定时间段之后收集生物流体，以及（6）分析生物流体的存在 的分析物。