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1.发明授权Multi-tier method of developing localized calibration models for non-invasive blood analyte prediction 有权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：US06512937B2
公开(公告)日：2003-01-28
申请号：US09825687
申请日：2001-04-03
IPC分类号： A61B500
CPC分类号： G01N21/274 , A61B5/1075 , A61B5/14532 , A61B5/1455 , A61B5/1495 , A61B5/7264 , A61B5/7267 , A61B2560/0223 , A61B2560/0233 , G01N21/359 , G01N21/4785 , G01N21/49 , Y10S128/92
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，使用主体人口统计学，光谱测量信息和适合于开发组织分类的其他设备测量来连续地改进类别。多层分类校准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。
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2.发明授权Multi-tier method of classifying sample spectra for non-invasive blood analyte prediction 失效对非侵入性血液分析物预测的样本光谱进行分类的多层方法公开(公告)号：US06512936B1
公开(公告)日：2003-01-28
申请号：US09665201
申请日：2000-09-18
IPC分类号： A61B500
CPC分类号： G06K9/6217 , A61B5/1075 , A61B5/14532 , A61B5/1455 , A61B5/1495 , A61B5/7264 , A61B2560/0223 , A61B2560/0233 , G01N21/274 , G01N21/359 , G01N21/4785 , G01N21/49 , Y10S128/92
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。
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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。
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公开(公告)号：US07183102B2
公开(公告)日：2007-02-27
申请号：US11122669
申请日：2005-05-04
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。
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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
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。
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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。
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7.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
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。
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公开(公告)号：US07233816B2
公开(公告)日：2007-06-19
申请号：US10917802
申请日：2004-08-12
申请人： Thomas B. Blank , George Acosta , Mutua Mattu , Marcy Makarewicz , Stephen L. Monfre , Alexander D. Lorenz , Timothy L. Ruchti
发明人： Thomas B. Blank , George Acosta , Mutua Mattu , Marcy Makarewicz , Stephen L. Monfre , Alexander D. Lorenz , Timothy L. Ruchti
IPC分类号： A61B5/00
CPC分类号： A61B5/0059 , A61B5/0071 , A61B5/0075 , A61B5/01 , A61B5/061 , A61B5/14532 , A61B5/1455 , A61B5/1495 , A61B5/6824 , A61B5/6833 , A61B5/6843 , A61B2560/0233 , A61B2562/12 , A61B2562/146
摘要： An optical sampling interface system minimizes and compensates error resulting from sampling variations and measurement site state fluctuations. Components include: An optical probe placement guide having an aperture wherein the optical probe is received, facilitates repeatable placement accuracy on surface of a tissue measurement site with minimal, repeatable disturbance to surface tissue. The aperture creates a tissue meniscus that minimizes interference due to surface irregularities and controls variation in tissue volume sampled; an occlusive element placed over the tissue meniscus isolates the meniscus from environmental fluctuations, stabilizing hydration at the site and thus, surface tension; an optical coupling medium eliminates air gaps between skin surface and optical probe; a bias correction element applies a bias correction to spectral measurements, and associated analyte measurements. When the guide is replaced, a new bias correction is determined for measurements done with the new placement. Separate components of system can be individually deployed.
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9.发明授权公开(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。
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公开(公告)号：US07606608B2
公开(公告)日：2009-10-20
申请号：US11008001
申请日：2004-12-08
申请人： Thomas B. Blank , George Acosta , Mutua Mattu , Marcy Makarewicz , Stephen L. Monfre , Alexander D. Lorenz , Timothy L. Ruchti , Kevin H. Hazen , Donovan D. Berry , Roxanne E. Abul-Haj
发明人： Thomas B. Blank , George Acosta , Mutua Mattu , Marcy Makarewicz , Stephen L. Monfre , Alexander D. Lorenz , Timothy L. Ruchti , Kevin H. Hazen , Donovan D. Berry , Roxanne E. Abul-Haj
IPC分类号： A61B5/1455
CPC分类号： G01N21/359 , A61B5/14532 , A61B5/1455 , A61B5/1495 , A61B5/6833
摘要： An optical sampling interface system is disclosed that minimizes and compensates for errors that result from sampling variations and measurement site state fluctuations. Embodiments of the invention use a guide that does at least one of, induce the formation of a tissue meniscus, minimize interference due to surface irregularities, control variation in the volume of tissue sampled, use a two-part guide system, use a guide that controls rotation of a sample probe and allows z-axis movement of the probe, use a separate base module and sample module in conjunction with a guide, and use a guide that controls rotation. Optional components include an occlusive element and a coupling fluid.
摘要翻译： 公开了一种光学采样接口系统，其最小化并补偿由采样变化和测量位置状态波动引起的误差。 本发明的实施例使用至少一个引导组织弯液面的形成的引导件，使由于表面不规则性引起的干扰最小化，控制组织体积的变化，使用两部分引导系统，使用指导 控制样品探针的旋转并允许探针的z轴移动，使用独立的基本模块和样品模块与导轨结合使用，并使用控制旋转的指南。 可选组件包括闭塞元件和耦合流体。
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