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    Multi-tier method of developing localized calibration models for non-invasive blood analyte prediction
    1.
    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。

    Apparatus using reference measurement for calibration
    2.
    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
    3.
    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。

    Noninvasive measurement of glucose through the optical properties of tissue
    5.
    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。

    Indirect measurement of tissue analytes through tissue properties
    9.
    发明授权
    Indirect measurement of tissue analytes through tissue properties 失效
    通过组织特性间接测量组织分析物

    公开(公告)号：US07039446B2

    公开(公告)日：2006-05-02

    申请号：US10349573

    申请日：2003-01-22

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

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

    IPC分类号： A61B5/00

    CPC分类号： A61B5/1455 ,  A61B5/0071 ,  A61B5/0075 ,  A61B5/14532 ,  A61B5/1495 ,  A61B2560/0223 ,  G01N21/274 ,  G01N21/31 ,  G01N21/33 ,  G01N21/359 ,  G01N21/65 ,  G01N2021/3595

    摘要： Methods and system for noninvasive determination of tissue analytes utilize tissue properties as reflected in key features of an analytical signal to improve measurement accuracy and precision. Physiological conditions such as changes in water distribution among tissue compartments lead to complex alterations in the measured analytical signal of skin, leading to a biased noninvasive analyte measurement. Changes in the tissue properties are detected by identifying key features in the analytical signal responsive to physiological variations. Conditions not conducive to the noninvasive measurement are detected. Noninvasive measurements that are biased by physiological changes in tissue are compensated. In an alternate embodiment, the analyte is measured indirectly based on natural physiological response of tissue to changes in analyte concentration. A system capable of such measurements is provided.

    摘要翻译： 非侵入性测定组织分析物的方法和系统利用分析信号的关键特征反映的组织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分析信号的复杂变化，导致偏向的非侵入性分析物测量。 通过识别响应于生理变化的分析信号中的关键特征来检测组织性质的变化。 检测到不利于非侵入性测量的条件。 由组织中生理变化偏向的无创测量得到补偿。 在替代实施方案中，基于组织对分析物浓度变化的天然生理反应间接测量分析物。 提供能够进行这种测量的系统。

    Method and apparatus for minimizing spectral effects attributable to tissue state variations during NIR-based non-invasive blood analyte determination
    10.
    发明授权
    Method and apparatus for minimizing spectral effects attributable to tissue state variations during NIR-based non-invasive blood analyte determination 有权
    用于最小化归因于基于NIR的非侵入性血液分析物测定期间的组织状态变化的光谱效应的方法和装置

    公开(公告)号：US06640117B2

    公开(公告)日：2003-10-28

    申请号：US09955531

    申请日：2001-09-17

    申请人： Marcy R. Makarewicz ,  Mutua Mattu ,  Thomas B. Blank ,  Stephen L. Monfre ,  Timothy L. Ruchti

    发明人： Marcy R. Makarewicz ,  Mutua Mattu ,  Thomas B. Blank ,  Stephen L. Monfre ,  Timothy L. Ruchti

    IPC分类号： A61B500

    CPC分类号： A61B5/1495 ,  A61B5/14532 ,  A61B5/1455 ,  A61B5/1491

    摘要： A method and apparatus for minimizing confounding effects in a noninvasive in-vivo spectral measurement caused by fluctuations in tissue state monitors a selected tissue state parameter spectroscopically and maintains the selected parameter within a target range, at which spectral effects attributable to the changes in the selected parameter are minimized. The invention includes both active and passive control. A preferred embodiment of the invention provides a method and apparatus for minimizing the confounding effects in near IR spectral measurements attributable to shifts in skin temperature at a tissue measurement site. Spectroscopic monitoring of skin temperature at the measurement site provides near-instantaneous temperature readings by eliminating thermal time constants. A thermistor positioned at the measurement site provides active control. The spectrometer and the temperature control device are incorporated into a single instrument for noninvasive measurement of blood glucose concentration.

    摘要翻译： 用于最小化由组织状态的波动引起的非侵入性体内光谱测量中的混杂效应的方法和装置通过光谱方式监测所选择的组织状态参数，并将所选择的参数保持在目标范围内，在该范围内，归因于所选择的变化的光谱效应 参数最小化。 本发明包括主动和被动控制。 本发明的一个优选实施例提供了一种方法和装置，用于最小化归因于组织测量部位的皮肤温度变化的近红外光谱测量中的混杂效应。 光谱监测测量点的皮肤温度通过消除热时间常数提供近乎瞬时的温度读数。 位于测量位置的热敏电阻提供主动控制。 光谱仪和温度控制装置被并入单个仪器中用于非侵入性测量血糖浓度。