METHOD FOR OPTICAL MEASUREMENTS OF TISSUE TO DETERMINE DISEASE STATE OR CONCENTRATION OF AN ANALYTE
    1.
    发明申请
    METHOD FOR OPTICAL MEASUREMENTS OF TISSUE TO DETERMINE DISEASE STATE OR CONCENTRATION OF AN ANALYTE 审中-公开
    用于确定疾病状态的组织的光学测量方法或分析仪的浓度

    公开(公告)号:WO2002082989A1

    公开(公告)日:2002-10-24

    申请号:PCT/US2002/006831

    申请日:2002-03-07

    CPC classification number: A61B5/1495 A61B5/14532 A61B5/1455 A61B5/7264

    Abstract: 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.

    Abstract translation: 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。

    METHOD FOR THE NON-INVASIVE DETERMINATION OF AN ANALYTE IN A SELECTED VOLUME OF TISSUE
    5.
    发明申请
    METHOD FOR THE NON-INVASIVE DETERMINATION OF AN ANALYTE IN A SELECTED VOLUME OF TISSUE 审中-公开
    非选择性地确定选定体积组织中分析物的方法

    公开(公告)号:WO2002060320A1

    公开(公告)日:2002-08-08

    申请号:PCT/US2001/050717

    申请日:2001-10-18

    Abstract: A method for the determination of concentrations of analytes, e. g., glucose, and other metabolites in human tissue, wherein the temperature of a defined cutaneous volume of tissue is controlled. The method involves calculating the concentration of an analyte in the tissue by taking into consideration the values of optical parameters of a sample of tissue measured in the defined cutaneous volume of the tissue at various temperatures. The selection of the defined volume is a function of the sampling distance along the surface of the tissue, the wavelength of light used to illuminate the tissue, and the temperature in the defined volume of tissue, which is a function of the temperature at the surface of the tissue. In an embodiment of the method of this invention, the temperature of the defined cutaneous volume of the tissue is varied within a defined physiological range to change the depth of penetration of light into the tissue, thereby achieving a depth profile for the optical signal. The method of this invention utilizes changes in temperature and selection of wavelengths to define cutaneous volumes below the surface of the tissue, in which volumes the concentration of an analyte can be determined.

    Abstract translation: 一种测定分析物浓度的方法, 例如葡萄糖和人体组织中的其它代谢物,其中控制组织的限定皮肤体积的温度。 该方法包括通过考虑在各种温度下在组织的定义的皮肤体积中测量的组织样品的光学参数的值来计算组织中分析物的浓度。 定义体积的选择是沿着组织表面的采样距离,用于照亮组织的光的波长和组织的限定体积中的温度的函数,其是表面温度的函数 的组织。 在本发明方法的一个实施方案中,组织的限定的皮肤体积的温度在规定的生理范围内变化,以改变光进入组织的深度,从而实现光信号的深度分布。 本发明的方法利用温度的变化和波长的选择来限定组织表面以下的皮肤体积,其中可以确定分析物的浓度。

    METHOD FOR THE NON-INVASIVE DETERMINATION OF AN ANALYTE IN A SELECTED VOLUME OF TISSUE
    7.
    发明公开
    METHOD FOR THE NON-INVASIVE DETERMINATION OF AN ANALYTE IN A SELECTED VOLUME OF TISSUE 审中-公开
    用于分析物的非侵入性测定方法在特定组织VOLUME

    公开(公告)号:EP1328191A1

    公开(公告)日:2003-07-23

    申请号:EP01999195.9

    申请日:2001-10-18

    Abstract: A method for the determination of concentrations of analytes, e. g., glucose, and other metabolites in human tissue, wherein the temperature of a defined cutaneous volume of tissue is controlled. The method involves calculating the concentration of an analyte in the tissue by taking into consideration the values of optical parameters of a sample of tissue measured in the defined cutaneous volume of the tissue at various temperatures. The selection of the defined volume is a function of the sampling distance along the surface of the tissue, the wavelength of light used to illuminate the tissue, and the temperature in the defined volume of tissue, which is a function of the temperature at the surface of the tissue. In an embodiment of the method of this invention, the temperature of the defined cutaneous volume of the tissue is varied within a defined physiological range to change the depth of penetration of light into the tissue, thereby achieving a depth profile for the optical signal. The method of this invention utilizes changes in temperature and selection of wavelengths to define cutaneous volumes below the surface of the tissue, in which volumes the concentration of an analyte can be determined.

    OPTICAL SENSOR HAVING A SELECTABLE SAMPLING DISTANCE FOR DETERMINATION OF ANALYTES
    8.
    发明公开
    OPTICAL SENSOR HAVING A SELECTABLE SAMPLING DISTANCE FOR DETERMINATION OF ANALYTES 审中-公开
    随着对距离选择性样品光学传感器用于测定分析

    公开(公告)号:EP1210582A1

    公开(公告)日:2002-06-05

    申请号:EP00953748.1

    申请日:2000-07-28

    Abstract: A method and apparatus for the measurement of trans-cutaneous diffuse reflectance at a single sampling distance for determining the concentration of an analyte in a biological sample, such as, for example, human tissue. The determination of the concentration of the analyte has been found to depend on the sampling distance and reaches an optimal result at a defined sampling distance for a given analyte and a given sample. The method involves measuring the light re-emitted from the sample at a distance from a light introduction site and correlating the intensity of the re-emitted light to the concentration of an analyte. For a given sample, the distance between the light collection site and a light introduction site (i.e., the sampling distance) corresponds to the depth from the surface into the sample at which scattering and absorption events significantly affect the intensity of re-emitted light (i.e., the sampling depth). Prior knowledge about the sample determines the optimal sampling depth for performing a measurement for a specific analyte and the corresponding sampling distance needed to reach that optimal sampling depth. Optimization of the sampling distance, as well as the correlation relationship, can be established in a calibration procedure.

    NONINVASIVE OPTICAL DETERMINATION OF HEMOGLOBIN AND HEMATOCRIT
    9.
    发明公开
    NONINVASIVE OPTICAL DETERMINATION OF HEMOGLOBIN AND HEMATOCRIT 审中-公开
    非侵入式光学测定血红蛋白和红细胞压积

    公开(公告)号:EP1282380A2

    公开(公告)日:2003-02-12

    申请号:EP01933059.6

    申请日:2001-05-07

    Abstract: A method for the determination of hemoglobin and hematocrit by means of an apparatus that is capable of controlling the temperature of a defined subcutaneous volume of human skin. The method involves a calculation of hemoglobin concentration and hematocrit value that takes into consideration the values of optical parameters of the sample at various pre-set temperatures. It employs steady state optical measurements of samples, such as, for example, human tissue, by means of a reflectance tissue photometer and localized control of the temperature of the sample. An optical signal from a defined subcutaneous volume of human skin is measured as the temperature of this volume is controlled. This allows determination of hemoglobin concentration and hematocrit value non-invasively in a population of subjects having different skin colors by means of steady state reflectance measurements. The determination of hemoglobin concentration and hematocrit value is useful for monitoring patients, testing at the point of care, and screening for anemia. This method has the advantage for the determination of analytes in weak cardiac pulse situations, such as, for example, in elderly patients.

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