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    Indirect measurement of tissue analytes through tissue properties
    3.
    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。

    Intra-serum and intra-gel for modeling human skin tissue
    4.
    发明授权
    Intra-serum and intra-gel for modeling human skin tissue 失效
    血清内和凝胶内用于建模人体皮肤组织

    公开(公告)号：US06777240B2

    公开(公告)日：2004-08-17

    申请号：US10241344

    申请日：2002-09-11

    申请人： Kevin H. Hazen ,  James Matthew Welch ,  Stephen F. Malin ,  Timothy L. Ruchti ,  Alexander D. Lorenz ,  Tamara L. Troy ,  Suresh Thennadil ,  Thomas B. Blank

    发明人： Kevin H. Hazen ,  James Matthew Welch ,  Stephen F. Malin ,  Timothy L. Ruchti ,  Alexander D. Lorenz ,  Tamara L. Troy ,  Suresh Thennadil ,  Thomas B. Blank

    IPC分类号： G01N3100

    CPC分类号： G01N21/274 ,  A61B5/0075 ,  A61B5/1075 ,  A61B5/14532 ,  A61B5/1455 ,  A61B5/1495 ,  A61B5/7264 ,  A61B2560/0223 ,  A61B2560/0233 ,  G01N21/359 ,  G01N21/4785 ,  G01N21/49 ,  Y10T436/10

    摘要： The invention provides a class of samples that model the human body. This family of samples is based upon emulsions of oil in water with lecithin acting as the emulsifier. These solutions that have varying particle sizes may be spiked with basis set components (albumin, urea and glucose) to simulate skin tissues further. The family of samples is such that other organic compounds such as collagen, elastin, globulin and bilirubin may be added, as can salts such as Na+, K+and Cl−. Layers of varying thickness with known index of refraction and particle size distributions may be generated using simple crosslinking reagents, such as collagen (gelatin). The resulting samples are flexible in each analyte's concentration and match the skin layers of the body in terms of the samples reduced scattering and absorption coefficients, &mgr;'s and &mgr;a. This family of samples is provided for use in the medical field where lasers and spectroscopy based analyzers are used in treatment of the body. In particular, knowledge may be gained on net analyte signal, photon depth of penetration, photon radial diffusion, photon interaction between tissue layers, photon density (all as a function of frequency) and on instrument parameter specifications such as resolution and required dynamic range (A/D bits required). In particular, applications to delineate such parameters have been developed for the application of noninvasive glucose determination in the near-IR region from 700 to 2500 nm with an emphasis on the region 1000 to 2500 nm (10,000 to 4,000 cm−1).

    摘要翻译： 本发明提供了一类对人体进行建模的样品。 该样品系基于水中的油与卵磷脂作为乳化剂的乳液。 具有不同粒径的这些溶液可以加入基础组分（白蛋白，尿素和葡萄糖）以进一步模拟皮肤组织。 样品家族可以加入其它有机化合物如胶原蛋白，弹性蛋白，球蛋白和胆红素，也可以加入诸如Na +，K +和Cl - 的盐。 可以使用简单的交联试剂如胶原（明胶）产生具有已知折射率和粒度分布的不同厚度的层。 所得样品在每种分析物的浓度上是柔性的，并且根据样品减少的散射和吸收系数mu和μa来匹配身体的皮肤层。 该样品系列用于医疗领域，其中使用激光和基于光谱的分析仪来治疗身体。 特别地，可以获得关于净分析物信号，光子穿透深度，光子径向扩散，组织层之间的光子相互作用，光子密度（全部作为频率的函数）以及仪器参数规格（例如分辨率和所需动态范围） 需要A / D位）。 特别地，已经开发出描绘这些参数的应用，用于在700至2500nm的近红外区域中应用非侵入性葡萄糖测定，重点在1000至2500nm（10,000至4000cm -1）的区域。

    Measurement site dependent data preprocessing method for robust calibration and prediction
    5.
    发明授权
    Measurement site dependent data preprocessing method for robust calibration and prediction 失效

    公开(公告)号：US07010336B2

    公开(公告)日：2006-03-07

    申请号：US10384023

    申请日：2003-03-07

    申请人： Alexander D. Lorenz ,  Timothy L. Ruchti ,  Thomas B. Blank ,  Kevin H. Hazen

    发明人： Alexander D. Lorenz ,  Timothy L. Ruchti ,  Thomas B. Blank ,  Kevin H. Hazen

    IPC分类号： A61B5/00

    CPC分类号： G01N21/359 ,  A61B5/0075 ,  A61B5/14532 ,  A61B5/1455 ,  A61B5/1495 ,  G01N21/49

    摘要： A solution for reducing interference in noninvasive spectroscopic measurements of tissue and blood analytes is provided. By applying a basis set representing various tissue components to a collected sample measurement, measurement interferences resulting from the heterogeneity of tissue, sampling site differences, patient-to-patient variation, physiological variation, and instrumental differences are reduced. Consequently, the transformed sample measurements are more suitable for developing calibrations that are robust with respect to sample-to-sample variation, variation through time, and instrument related differences. In the calibration phase, data associated with a particular tissue sample site is corrected using a selected subset of data within the same data set. This method reduces the complexity of the data and reduces the intra-subject, inter-subject, and inter-instrument variations by removing interference specific to the respective data subset. In the measurement phase, the basis set correction is applied using a minimal number of initial samples collected from the sample site(s) where future samples will be collected.

    Intra-serum and intra-gel for modeling human skin tissue
    6.
    发明授权
    Intra-serum and intra-gel for modeling human skin tissue 失效
    血清内和凝胶内用于建模人体皮肤组织

    公开(公告)号：US06475800B1

    公开(公告)日：2002-11-05

    申请号：US09502877

    申请日：2000-02-10

    申请人： Kevin H. Hazen ,  James Matthew Welch ,  Stephen F. Malin ,  Timothy L. Ruchti ,  Alexander D. Lorenz ,  Tamara L. Troy ,  Suresh Thennadil ,  Thomas B. Blank

    发明人： Kevin H. Hazen ,  James Matthew Welch ,  Stephen F. Malin ,  Timothy L. Ruchti ,  Alexander D. Lorenz ,  Tamara L. Troy ,  Suresh Thennadil ,  Thomas B. Blank

    IPC分类号： G01N3100

    CPC分类号： G01N21/274 ,  A61B5/0075 ,  A61B5/1075 ,  A61B5/14532 ,  A61B5/1455 ,  A61B5/1495 ,  A61B5/7264 ,  A61B2560/0223 ,  A61B2560/0233 ,  G01N21/359 ,  G01N21/4785 ,  G01N21/49 ,  Y10T436/10

    摘要： The invention provides a class of samples that model the human body. This family of samples is based upon emulsions of oil in water with lecithin acting as the emulsifier. These solutions that have varying particle sizes may be spiked with basis set components (albumin, urea and glucose) to simulate skin tissues further. The family of samples is such that other organic compounds such as collagen, elastin, globulin and bilirubin may be added, as can salts such as Na+, K+ and Cl−. Layers of varying thickness with known index of refraction and particle size distributions may be generated using simple crosslinking reagents, such as collagen (gelatin). The resulting samples are flexible in each analyte's concentration and match the skin layers of the body in terms of the samples reduced scattering and absorption coefficients, &mgr;ms and &mgr;ma. This family of samples is provided for use in the medical field where lasers and spectroscopy based analyzers are used in treatment of the body. In particular, knowledge may be gained on net analyte signal, photon depth of penetration, photon radial diffusion, photon interaction between tissue layers, photon density (all as a function of frequency) and on instrument parameter specifications such as resolution and required dynamic range (A/D bits required). In particular, applications to delineate such parameters have been developed for the application of noninvasive glucose determination in the near-IR region from 700 to 2500 nm with an emphasis on the region 1000 to 2500 nm (10,000 to 4,000 cm−1).

    摘要翻译： 本发明提供了一类对人体进行建模的样品。 该样品系基于水中的油与卵磷脂作为乳化剂的乳液。 具有不同粒径的这些溶液可以加入基础组分（白蛋白，尿素和葡萄糖）以进一步模拟皮肤组织。 样品家族可以加入诸如胶原，弹性蛋白，球蛋白和胆红素的其它有机化合物，也可以加入诸如Na +，K +和Cl-的盐。 可以使用简单的交联试剂如胶原（明胶）产生具有已知折射率和粒度分布的不同厚度的层。 所得样品在每种分析物的浓度上是灵活的，并且根据样品减少的散射和吸收系数，妈妈和玛玛来匹配身体的皮肤层。 该样品系列用于医疗领域，其中使用激光和基于光谱的分析仪来治疗身体。 特别地，可以获得关于净分析物信号，光子穿透深度，光子径向扩散，组织层之间的光子相互作用，光子密度（全部作为频率的函数）以及仪器参数规格（例如分辨率和所需动态范围） 需要A / D位）。 特别地，已经开发了描绘这些参数的应用，用于在700至2500nm的近红外区域中应用非侵入性葡萄糖测定，重点在1000至2500nm（10,000至4000cm -1）的区域。

    Apparatus using reference measurement for calibration
    7.
    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
    8.
    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。