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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：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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3.发明授权公开(公告)号：US07010336B2
公开(公告)日：2006-03-07
申请号：US10384023
申请日：2003-03-07
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.
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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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公开(公告)号：US07519406B2
公开(公告)日：2009-04-14
申请号：US11117104
申请日：2005-04-27
申请人： Thomas B. Blank , George M. Acosta , Timothy L. Ruchti , Mutua Mattu , Alexander D. Lorenz , Kevin H. Hazen , James R. Henderson
发明人： Thomas B. Blank , George M. Acosta , Timothy L. Ruchti , Mutua Mattu , Alexander D. Lorenz , Kevin H. Hazen , James R. Henderson
IPC分类号： A61B5/1455
CPC分类号： A61B5/1455 , A61B5/14532 , A61B5/1495 , A61B5/4869 , A61B2560/0223 , A61B2560/0233 , A61B2562/0242 , G01N21/359
摘要： A method and apparatus are provided for noninvasive sampling. More particularly, the method and apparatus relate to control of motion of an optical sample probe interface relative to a tissue sample site. A dynamic probe interface, is used to collect spectra of a targeted sample, control positioning of the sample probe relative to the tissue sample in terms of at least one of x-, y-, and z-axes, and/or control of sample tissue displacement to minimize spectral variations resulting from the sampling process and increase analyte property estimation precision and accuracy.
摘要翻译： 提供了一种用于无创采样的方法和装置。 更具体地，该方法和装置涉及光学样本探针界面相对于组织样本位点的运动的控制。 使用动态探针接口来收集目标样品的光谱，根据x-，y-和z-轴中的至少一个来控制样品探针相对于组织样品的定位和/或样品的控制 组织位移以最小化由采样过程导致的频谱变化，并增加分析物质的估计精度和精度。
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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。
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7.发明授权Method and apparatus for enhanced estimation of an analyte property through multiple region transformation 有权用于通过多区域变换增强对分析物特性的估计的方法和装置公开(公告)号：US07620674B2
公开(公告)日：2009-11-17
申请号：US10976530
申请日：2004-10-29
CPC分类号： A61B5/1455 , A61B5/14532 , A61B5/1495 , A61B2560/0223 , G01N21/359
摘要： The invention comprises transformation of a section of a data block independently of the transformation of separate or overlapping data blocks to determine a property related to the original matrix, where each of the separate or overlapping data blocks are derived from an original data matrix. The transformation enhances parameters of a first data block over a given region of an axis of the data matrix, such as signal-to-noise, without affecting analysis of a second data block derived from the data matrix. This allows for enhancement of analysis of an analyte property, such as concentration, represented within the original data matrix. A separate decomposition and factor selection for each selected data matrix is performed with subsequent score matrix concatenization. The combined score matrix is used to generate a model that is subsequently used to estimate a property, such as concentration represented in the original data matrix.
摘要翻译： 本发明包括独立于单独或重叠的数据块的变换的数据块的一部分的变换，以确定与原始矩阵相关的属性，其中每个分离的或重叠的数据块是从原始数据矩阵导出的。 该变换增强了数据矩阵的轴的给定区域（例如信号到噪声）上的第一数据块的参数，而不影响从数据矩阵导出的第二数据块的分析。 这允许增强在原始数据矩阵内表示的分析物质（例如浓度）的分析。 对于每个选择的数据矩阵进行单独的分解和因子选择，随后的得分矩阵连接。 组合得分矩阵用于生成随后用于估计属性的模型，例如在原始数据矩阵中表示的浓度。
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公开(公告)号：US07436511B2
公开(公告)日：2008-10-14
申请号：US11188064
申请日：2005-07-22
CPC分类号： G01N21/274 , G01J3/28 , G01J3/433 , G01N21/359 , G01N2201/129 , G01N2201/1293
摘要： The invention comprises a method and apparatus for enhancing the analysis of noninvasive spectra, resulting in improved analytical performance. More particularly, the invention comprises a method and apparatus for processing noninvasive spectra with an analyte filter that preferably rejects variation likely to be detrimental to the measurement system, while passing signal that probabilistically is unique to the target analyte. Subsequently, the analyte filtered data are used to estimate an analyte property, such as a glucose concentration, in the presence of noise, interferences, state changes, and/or across analyzers.
摘要翻译： 本发明包括用于增强非侵入光谱分析的方法和装置，从而提高分析性能。 更具体地，本发明包括用分析物过滤器处理非侵入光谱的方法和装置，其优选地拒绝可能对测量系统有害的变化，同时传递概率地对目标分析物是唯一的信号。 随后，分析物过滤的数据用于在存在噪声，干扰，状态变化和/或跨分析仪的情况下估计分析物质（例如葡萄糖浓度）。
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公开(公告)号：US07640140B2
公开(公告)日：2009-12-29
申请号：US11095331
申请日：2005-03-30
CPC分类号： A61B5/14532
摘要： This invention provides a method and apparatus that corrects for tissue related interference calibration and/or measurement of biological parameters noninvasively. The invention concerns such terms as outlier identification, filtering, spectral correction, and baseline subtraction steps that, when used together, provides for noninvasive measurement of biological parameters, such as glucose concentration.
摘要翻译： 本发明提供一种非侵入性校正组织相关干扰校准和/或生物参数测量的方法和装置。 本发明涉及诸如异常值识别，过滤，光谱校正和基线减法步骤之类的术语，当它们一起使用时，提供诸如葡萄糖浓度的生物学参数的非侵入性测量。
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10.发明授权Intelligent system for detecting errors and determining failure modes in noninvasive measurement of blood and tissue analytes 有权用于检测血液和组织分析物的非侵入性测量中的错误和确定失败模式的智能系统公开(公告)号：US06788965B2
公开(公告)日：2004-09-07
申请号：US10211478
申请日：2002-08-01
申请人： Timothy L. Ruchti , Christopher C. Briggs , Thomas B. Blank , Alexander D. Lorenz , Mutua Mattu , Marcy Makarewicz
发明人： Timothy L. Ruchti , Christopher C. Briggs , Thomas B. Blank , Alexander D. Lorenz , Mutua Mattu , Marcy Makarewicz
IPC分类号： A61B500
CPC分类号： A61B5/1459 , A61B5/0064 , A61B5/0075 , A61B5/01 , A61B5/14532 , A61B5/14546 , A61B5/1495 , A61B5/441 , A61B5/7264 , G01N21/274 , G01N21/359 , G06N3/004
摘要： An intelligent system for detecting errors and determining failure modes operates on an absorbance spectrum of in vivo skin tissue. Application of the system results in improved prediction accuracy through rejection of invalid and poor samples. System components include a noninvasive blood glucose meter, such as a near IR spectrometer, an error detection system (EDS); a system for diagnosing and mitigating errors; and a reporting method. In the EDS, a pattern classification engine and hierarchy of levels analyzes, detects and diagnoses instrument, interface and sample errors manifested in the spectrum to determine suitability of an absorbance spectrum for blood glucose measurement. The final component of the system evaluates the error condition, diagnoses the specific mode of failure (if necessary) and reports actions to be taken. Sub-components and levels of the EDS can operate independently of the other system elements to the benefit of a noninvasive glucose measurement system.
摘要翻译： 用于检测错误并确定故障模式的智能系统对体内皮肤组织的吸收光谱进行操作。 该系统的应用通过排除无效和差的样本提高了预测精度。 系统组件包括无创血糖仪，例如近红外光谱仪，误差检测系统（EDS）; 用于诊断和减轻错误的系统; 和报告方法。 在EDS中，模式分类引擎和级别层次分析，检测和诊断谱图中出现的仪器，界面和样本误差，以确定血糖测量的吸收光谱的适用性。 系统的最终组件评估错误状况，诊断具体的失败模式（如有必要）并报告要采取的操作。 EDS的子组件和级别可以独立于其他系统元件运行，以有益于非侵入性葡萄糖测量系统。
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