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    Use of targeted glycemic profiles in the calibration of a noninvasive blood glucose monitor
    1.
    发明授权
    Use of targeted glycemic profiles in the calibration of a noninvasive blood glucose monitor 失效

    公开(公告)号：US06487429B2

    公开(公告)日：2002-11-26

    申请号：US09766872

    申请日：2001-01-18

    申请人： Linda Hockersmith ,  Thomas B. Blank ,  Stephen L. Monfre ,  Timothy L. Ruchti

    发明人： Linda Hockersmith ,  Thomas B. Blank ,  Stephen L. Monfre ,  Timothy L. Ruchti

    IPC分类号： A61B500

    CPC分类号： A61B5/14532

    摘要： A method of calibrating a non-invasive blood glucose measurement instrument to a diabetic test subject employs targeted glycemic profiles in anti-correlated pairs. During calibration, reference blood glucose determinations are made using conventional invasive sampling methods. Concurrently, noninvasive spectral measurements are made using the noninvasive glucose monitor. Through controlled oral ingestion by the subject of calculated amounts of carbohydrate, the subject's blood glucose level is manipulated to mimic the patterns of the targeted profiles. During a first visit, a first profile of a pair is induced; during a second visit the inverse of the first profile is induced. The targeted profiles produce reference blood glucose values in which correlation to sampling factors is reduced or eliminated, thus the resulting calibration is correlated to glucose, and not to other analytes, sampling factors or environmental factors. A formula is provided for calculating the required amount of carbohydrate to ingest to induce a targeted glycemic profile in a test subject.

    METHOD OF SCREENING FOR DISORDERS OF GLUCOSE METABOLISM
    2.
    发明申请
    METHOD OF SCREENING FOR DISORDERS OF GLUCOSE METABOLISM 审中-公开
    葡萄糖代谢障碍筛查方法

    公开(公告)号：US20090098587A1

    公开(公告)日：2009-04-16

    申请号：US12099740

    申请日：2008-04-08

    申请人： Donald Hetzel ,  Stephen L. Monfre ,  Kevin H. Hazen ,  Timothy L. Ruchti ,  Thomas B. Blank ,  Linda Hockersmith ,  Andrew Cone

    发明人： Donald Hetzel ,  Stephen L. Monfre ,  Kevin H. Hazen ,  Timothy L. Ruchti ,  Thomas B. Blank ,  Linda Hockersmith ,  Andrew Cone

    IPC分类号： C12Q1/54

    CPC分类号： C12Q1/54 ,  A61B5/14532 ,  A61B5/7264 ,  G01N33/66 ,  G01N2800/042 ,  G16H50/20 ,  G16H50/70

    摘要： A method of screening for disorders of glucose metabolism such as impaired glucose tolerance and diabetes allows prevention, or early detection and treatment of diabetic complications such as cardiovascular disease, retinopathy, and other disorders of the major organs and systems. A mathematical algorithm evaluates the shape of a subject's glucose profile and classifies the profile into one of several predefined clusters, each cluster corresponding either to a normal condition or one of several abnormal conditions. The series of blood glucose values making up the glucose tolerance curve may be measured using any glucose analyzer including: invasive, minimally invasive and noninvasive types. The method is executed on a processing device programmed to perform the steps of the method. Depending on the outcome of the screening, a subject may be provided with additional information concerning their condition and/or counseled to consult further with their health care provider.

    摘要翻译： 筛选葡萄糖代谢紊乱如葡萄糖耐量异常和糖尿病的方法允许预防或早期检测和治疗糖尿病并发症如心血管疾病，视网膜病变和主要器官和系统的其他病症。 数学算法评估受试者的葡萄糖谱的形状并将轮廓分类为几个预定义的簇之一，每个簇对应于正常条件或几个异常条件之一。 构成葡萄糖耐量曲线的一系列血糖值可以使用任何葡萄糖分析仪来测量，包括：侵入性，微创和非侵入性类型。 该方法在被编程为执行该方法的步骤的处理装置上执行。 根据筛查结果，可以向受试者提供有关其病情的信息和/或咨询，以进一步咨询其医护人员。

    Apparatus using reference measurement for calibration
    4.
    发明授权
    Apparatus using reference measurement for calibration 失效
    使用参考测量仪进行校准

    公开(公告)号：US07183102B2

    公开(公告)日：2007-02-27

    申请号：US11122669

    申请日：2005-05-04

    申请人： Stephen L. Monfre ,  Kevin H. Hazen ,  Timothy L. Ruchti ,  Thomas B. Blank ,  James R. Henderson

    发明人： Stephen L. Monfre ,  Kevin H. Hazen ,  Timothy L. Ruchti ,  Thomas B. Blank ,  James R. Henderson

    IPC分类号： C12M1/34

    CPC分类号： A61B5/1455 ,  A61B5/14532 ,  A61B5/1495 ,  G01N21/274 ,  G01N21/359 ,  G01N21/49

    摘要： A method and apparatus for calibrating noninvasive or implantable glucose analyzers that uses either alternative invasive glucose determinations or noninvasive glucose determinations to calibrate noninvasive or implantable glucose analyzers. Use of an alternative invasive or noninvasive glucose determination in the calibration allows minimization of errors due to sampling methodology, and spatial and temporal variations that are built into the calibration model. An additional embodiment uses statistical correlations between noninvasive and alternative invasive glucose determinations and traditional invasive glucose determinations to adjust noninvasive or alternative invasive glucose concentrations to traditional invasive glucose concentrations. The invention provides a means for calibrating on the basis of glucose determinations that reflect the matrix observed and the variable measured by the analyzer more closely. A glucose analyzer couples an invasive fingerstick meter to a noninvasive glucose analyzer for calibration, validation, adaptation, and safety check of the calibration model embodied in the noninvasive analyzer.

    摘要翻译： 一种用于校准无创或可植入的葡萄糖分析仪的方法和装置，其使用替代的侵入性葡萄糖测定或非侵入性葡萄糖测定来校准无创或可植入的葡萄糖分析仪。 在校准中使用替代入侵或非侵入性葡萄糖测定可以最大限度地减少由采样方法引起的误差，以及内置于校准模型中的空间和时间变化。 另外的实施方案使用非侵入性和替代性侵入性葡萄糖测定与传统的侵入性葡萄糖测定之间的统计学相关性来调整对于传统侵入性葡萄糖浓度的非侵入性或替代性侵入性葡萄糖浓度。 本发明提供了一种用于基于反映观察到的基质的葡萄糖测定和由分析仪更仔细测量的变量进行校准的方法。 葡萄糖分析仪将无创手指计与无创葡萄糖分析仪相结合，用于非侵入性分析仪中体现的校准模型的校准，验证，适应和安全性检查。

    Method and apparatus using alternative site glucose determinations to calibrate and maintain noninvasive and implantable analyzers
    5.
    发明授权
    Method and apparatus using alternative site glucose determinations to calibrate and maintain noninvasive and implantable analyzers 失效
    使用替代部位葡萄糖测定来校准和维护无创和可植入分析仪的方法和设备

    公开(公告)号：US06998247B2

    公开(公告)日：2006-02-14

    申请号：US10377916

    申请日：2003-02-28

    申请人： Stephen L. Monfre ,  Kevin H. Hazen ,  Timothy L. Ruchti ,  Thomas B. Blank ,  James R. Henderson

    发明人： Stephen L. Monfre ,  Kevin H. Hazen ,  Timothy L. Ruchti ,  Thomas B. Blank ,  James R. Henderson

    IPC分类号： C12Q1/54

    CPC分类号： A61B5/1455 ,  A61B5/14532 ,  A61B5/1495 ,  G01N21/274 ,  G01N21/359 ,  G01N21/49

    摘要： Methods for calibrating noninvasive or implantable glucose analyzers utilize either alternative invasive glucose determinations or noninvasive glucose determinations for calibrating noninvasive or implantable glucose analyzers. Use of an alternative invasive or noninvasive glucose determination in the calibration allows minimization of errors due to sampling methodology, and spatial and temporal variation that are built into the calibration model. An additional method uses statistical correlations between noninvasive and alternative invasive glucose determinations and traditional invasive glucose determinations to adjust noninvasive or alternative invasive glucose concentrations to traditional invasive glucose concentrations. The methods provide a means for calibrating on the basis of glucose determinations that reflect the matrix observed and the variable measured by the analyzer more closely. A glucose analyzer couples an invasive fingerstick meter to a noninvasive glucose analyzer for calibration, validation, adaptation, and safety check of the calibration model embodied in the noninvasive analyzer.

    摘要翻译： 用于校准无创或可植入葡萄糖分析仪的方法利用替代侵入性葡萄糖测定或非侵入性葡萄糖测定来校准无创或可植入的葡萄糖分析仪。 在校准中使用替代入侵或无创葡萄糖测定可以最小化由采样方法引起的误差，以及内置于校准模型中的空间和时间变化。 一种额外的方法使用非侵入性和替代性侵入性葡萄糖测定与传统侵入性葡萄糖测定之间的统计学相关性来调整传统侵入性葡萄糖浓度的无创或替代侵入性葡萄糖浓度。 这些方法提供了一种基于反映观察到的基质的葡萄糖测定和由分析仪更接近测量的变量进行校准的方法。 葡萄糖分析仪将无创手指计与无创葡萄糖分析仪相结合，用于非侵入性分析仪中体现的校准模型的校准，验证，适应和安全性检查。

    Apparatus and method for quantification of tissue hydration using diffuse reflectance spectroscopy
    7.
    发明授权
    Apparatus and method for quantification of tissue hydration using diffuse reflectance spectroscopy 失效
    使用漫反射光谱法定量组织水化的装置和方法

    公开(公告)号：US06675029B2

    公开(公告)日：2004-01-06

    申请号：US10183660

    申请日：2002-06-25

    申请人： Stephen L. Monfre ,  Timothy L. Ruchti ,  Thomas B. Blank ,  Brian J. Wenzel

    发明人： Stephen L. Monfre ,  Timothy L. Ruchti ,  Thomas B. Blank ,  Brian J. Wenzel

    IPC分类号： A61B500

    CPC分类号： A61B5/444 ,  A61B5/0062 ,  A61B5/0075 ,  A61B5/1075 ,  A61B5/14532 ,  A61B5/1455 ,  A61B5/7264 ,  G01N21/3554 ,  G01N21/359 ,  G01N21/4785 ,  G01N21/49 ,  G01N2201/129

    摘要： An apparatus and method for non-destructively estimating a tissue property, such as hydration, of a living subject utilizes in vivo spectral measurements made by irradiating skin tissue with near infrared (NIR) light. The apparatus includes a spectroscopic instrument in conjunction with a subject interface. The resulting spectra are passed to an analyzer for further processing, which includes detecting and eliminating invalid spectral measurements, and preprocessing to increase the signal-to-noise ratio. Finally, an estimation model developed from an exemplary set of measurements is applied to predict the tissue hydration for the sample. The method of tissue hydration measurement provides additional information about primary sources of systematic tissue variability, namely, the water content of the epidermal layer of skin and the penetration depth of the incident light. Tissue hydration measurement is therefore suitable for further spectral analysis and quantification of biological and chemical compounds, such as analytes.

    摘要翻译： 用于非破坏性地估计活体受试者的组织性质（例如水合）的装置和方法利用通过用近红外（NIR）光照射皮肤组织进行的体内光谱测量。 该装置包括结合主体界面的光谱仪器。 所得到的光谱被传递到分析器以用于进一步处理，其包括检测和消除无效光谱测量以及预处理以增加信噪比。 最后，应用从示例性测量集合开发的估计模型来预测样品的组织水合。 组织水合测量的方法提供关于系统组织变异性的主要来源的附加信息，即皮肤表皮层的水含量和入射光的穿透深度。 因此，组织水合测量适用于生物和化学化合物（如分析物）的进一步光谱分析和定量。

    Multi-tier method of developing localized calibration models for non-invasive blood analyte prediction
    8.
    再颁专利
    Multi-tier method of developing localized calibration models for non-invasive blood analyte prediction 失效
    开发用于非侵入性血液分析物预测的局部校准模型的多层方法

    公开(公告)号：USRE41333E1

    公开(公告)日：2010-05-11

    申请号：US11046673

    申请日：2005-01-27

    申请人： Thomas B. Blank ,  Stephen L. Monfre ,  Timothy L. Ruchti ,  Suresh N. Thennadill

    发明人： Thomas B. Blank ,  Stephen L. Monfre ,  Timothy L. Ruchti ,  Suresh N. Thennadill

    IPC分类号： A61B5/1455

    CPC分类号： G01N21/274 ,  A61B5/1075 ,  A61B5/14532 ,  A61B5/1455 ,  A61B5/1495 ,  A61B5/7264 ,  A61B2560/0223 ,  A61B2560/0233 ,  G01N21/359 ,  G01N21/4785 ,  G01N21/49

    摘要： A method of multi-tier classification and calibration in noninvasive blood analyte prediction minimizes prediction error by limiting co-varying spectral interferents. Tissue samples are categorized based on subject demographic and instrumental skin measurements, including in vivo near-IR spectral measurements. A multi-tier intelligent pattern classification sequence organizes spectral data into clusters having a high degree of internal consistency in tissue properties. In each tier, categories are successively refined using subject demographics, spectral measurement information and other device measurements suitable for developing tissue classifications.The multi-tier classification approach to calibration utilizes multivariate statistical arguments and multi-tiered classification using spectral features. Variables used in the multi-tiered classification can be skin surface hydration, skin surface temperature, tissue volume hydration, and an assessment of relative optical thickness of the dermis by the near-IR fat band. All tissue parameters are evaluated using the NIR spectrum signal along key wavelength segments.

    摘要翻译： 非侵入性血液分析物预测中的多层分类和校准方法通过限制共同变化的光谱干扰来最小化预测误差。 组织样品根据受试者的人口统计学和仪器皮肤测量进行分类，包括体内近红外光谱测量。 多层智能图案分类序列将光谱数据组织成具有组织性质内部高度一致性的簇。 在每个层次中，使用主题人口统计学，光谱测量信息和适合于开发组织分类的其它装置测量法来连续地改进类别。 校准的多层分类方法利用多变量统计学参数和使用光谱特征的多层次分类。 用于多层次分类的变量可以是皮肤表面水合，皮肤表面温度，组织体积水合，以及近红外脂肪带对真皮的相对光学厚度的评估。 使用沿关键波长段的NIR光谱信号评估所有组织参数。

    Noninvasive measurement of glucose through the optical properties of tissue
    10.
    发明授权
    Noninvasive measurement of glucose through the optical properties of tissue 有权
    通过组织的光学性质对葡萄糖进行无创测量

    公开(公告)号：US06990364B2

    公开(公告)日：2006-01-24

    申请号：US10297736

    申请日：2002-01-25

    申请人： Timothy L. Ruchti ,  Suresh N. Thennadil ,  Thomas B. Blank ,  Alexander Lorenz ,  Stephen L. Monfre

    发明人： Timothy L. Ruchti ,  Suresh N. Thennadil ,  Thomas B. Blank ,  Alexander Lorenz ,  Stephen L. Monfre

    IPC分类号： A61B5/00

    CPC分类号： A61B5/1455 ,  A61B5/14532 ,  A61B5/1495 ,  A61B2560/0223 ,  G01N21/31 ,  G01N21/33 ,  G01N21/359 ,  G01N2021/3595

    摘要： Methods and apparatus for noninvasive determination of blood analytes, such as glucose, through NIR spectroscopy utilize optical properties of tissue as reflected in key spectroscopic features to improve measurement accuracy and precision. Physiological conditions such as changes in water distribution among tissue compartments lead to complex alterations in the measured absorbance spectrum of skin and reflect a modification in the effective pathlength of light, leading to a biased noninvasive glucose measurement. Changes in the optical properties of tissue are detected by identifying key features responsive to physiological variations. Conditions not conducive to noninvasive measurement of glucose are detected. Noninvasive glucose measurements that are biased by physiological changes in tissue are compensated. In an alternate embodiment, glucose is measured indirectly based on natural physiological response of tissue to glucose concentration. A spectroscopic device capable of such measurements is provided.

    摘要翻译： 通过近红外光谱对血液分析物（如葡萄糖）进行无创测定的方法和设备利用关键光谱特征反映的组织光学性质来提高测量精度和精度。 生理条件如组织间隔水分配变化导致测量的皮肤吸收光谱的复杂变化，并反映了有效光线长度的变化，导致偏向的非侵入性葡萄糖测量。 通过识别响应于生理变化的关键特征来检测组织的光学性质的变化。 检测不利于葡萄糖无创测量的条件。 通过组织中的生理变化偏置的非侵入性葡萄糖测量被补偿。 在替代实施方案中，基于组织对葡萄糖浓度的天然生理反应间接测量葡萄糖。 提供能够进行这种测量的光谱装置。