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1. 发明授权

US07640140B2 Method of processing noninvasive spectra 有权
标题翻译：无创光谱处理方法
公开(公告)号：US07640140B2
公开(公告)日：2009-12-29
申请号：US11095331
申请日：2005-03-30
申请人： Timothy L. Ruchti , Thomas B. Blank , Alexander D. Lorenz
发明人： Timothy L. Ruchti , Thomas B. Blank , Alexander D. Lorenz
IPC分类号： G06F19/00 , A61B5/00
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。

2. 发明授权

US06788965B2 Intelligent system for detecting errors and determining failure modes in noninvasive measurement of blood and tissue analytes 有权
标题翻译：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。

3. 发明授权

US07233816B2 Optical sampling interface system for in vivo measurement of tissue 有权
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.

4. 发明授权

US07010336B2 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.

5. 发明授权

US07509153B2 Method and apparatus for control of skin perfusion for indirect glucose measurement 失效
标题翻译：用于控制间接葡萄糖测量的皮肤灌注的方法和装置
公开(公告)号：US07509153B2
公开(公告)日：2009-03-24
申请号：US10384049
申请日：2003-03-07
申请人： Thomas B. Blank , Timothy L. Ruchti , Mutua Mattu , Marcy Makarewicz , Stephen L. Monfre , Alexander D. Lorenz
发明人： Thomas B. Blank , Timothy L. Ruchti , Mutua Mattu , Marcy Makarewicz , Stephen L. Monfre , Alexander D. Lorenz
IPC分类号： A61B5/1455
CPC分类号： A61B5/1455 , A61B5/14532 , A61B5/1491 , A61B5/1495 , A61B2560/0223 , G01N21/31 , G01N21/33 , G01N21/359 , G01N21/65 , G01N2021/3595
摘要： A method and apparatus for noninvasive glucose measurement measures glucose indirectly from the natural response of tissue to variations in analyte concentration. The indirect measurement method utilizes factors affected by or correlated with the concentration of glucose, such as refractive index, electrolyte distribution or tissue scattering. Measurement reliability is greatly improved by stabilizing optical properties of the tissue at the measurement site, thus blood perfusion rates at the sample site are regulated. Perfusion is monitored and stabilized by spectroscopically measuring a control parameter, such as skin temperature, that directly affects perfusion. The control parameter is maintained in a range about a set point, thus stabilizing perfusion. Skin temperature is controlled using a variety of means, including the use of active heating and cooling elements, passive devices, such as thermal wraps, and through the use of a heated coupling medium having favorable heat transfer properties.
摘要翻译：用于非侵入性葡萄糖测量的方法和装置从组织的自然反应间接测量葡萄糖对分析物浓度的变化。间接测量方法利用受葡萄糖浓度影响或与葡萄糖浓度相关的因素，如折射率，电解质分布或组织散射。通过稳定测量部位的组织的光学特性，可以大大提高测量可靠性，从而调节样品位置的血液灌注速率。通过光谱测量直接影响灌注的控制参数（如皮肤温度）来监测和稳定灌注。控制参数保持在设定点的范围内，从而稳定灌注。使用各种手段控制皮肤温度，包括使用主动加热和冷却元件，无源器件，例如热封，以及通过使用具有良好传热特性的加热耦合介质。

6. 发明授权

US07206623B2 Optical sampling interface system for in vivo measurement of tissue 失效
公开(公告)号：US07206623B2
公开(公告)日：2007-04-17
申请号：US10170921
申请日：2002-06-12
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.

7. 发明授权

US06876931B2 Automatic process for sample selection during multivariate calibration 失效
标题翻译：多变量校准中样品选择的自动过程
公开(公告)号：US06876931B2
公开(公告)日：2005-04-05
申请号：US10211142
申请日：2002-08-02
申请人： Alexander D. Lorenz , Timothy L. Ruchti , Thomas B. Blank
发明人： Alexander D. Lorenz , Timothy L. Ruchti , Thomas B. Blank
IPC分类号： A61B5/00 , G01N21/27 , G01N21/35 , G01N31/00
CPC分类号： A61B5/1455 , A61B5/14532 , A61B5/1495 , G01N21/274 , G01N21/359
摘要： A process for enhancing a multivariate calibration through optimization of a calibration data set operates on a large calibration set of samples that includes measurements and associated reference values to automatically select an optimal sub-set of samples that enables calculation of an optimized calibration model. The process is automatic and bases sample selection on two basic criteria: enhancement of correlation between a partner variable extracted from the independent variable and the dependent variable and reduction of correlation between the dependent variable and interference. The method includes two fundamental steps: evaluation, assigning a measurement of calibration suitability to a subset of data; and optimization, selecting an optimal subset of data as directed by the measurement of suitability. The process is particularly applied in enhancing and automating the calibration process for non-invasive measurement glucose measurement but can be applied in any system involving the calculation of multivariate models from empirical data sets.
摘要翻译：通过优化校准数据集来增强多变量校准的过程在包括测量和相关参考值的大型校准样本集上进行操作，以自动选择能够计算优化校准模型的最佳样本子集。该过程是自动的，并且基于两个基本标准的基础样本选择：增强从独立变量提取的伴随变量与因变量之间的相关性，并降低因变量与干扰之间的相关性。该方法包括两个基本步骤：评估，将校准适用性的度量分配给数据子集; 和优化，根据适合性的测量指导选择最佳的数据子集。该过程特别应用于增强和自动化非侵入性测量葡萄糖测量的校准过程，但可以应用于涉及从经验数据集计算多变量模型的任何系统中。

8. 发明授权

US06697654B2 Targeted interference subtraction applied to near-infrared measurement of analytes 失效
标题翻译：目标干扰减去应用于分析物的近红外测量
公开(公告)号：US06697654B2
公开(公告)日：2004-02-24
申请号：US10183906
申请日：2002-06-25
申请人： Alexander D. Lorenz , Thomas B. Blank , Timothy L. Ruchti
发明人： Alexander D. Lorenz , Thomas B. Blank , Timothy L. Ruchti
IPC分类号： A61B500
CPC分类号： G01N21/4785 , A61B5/1075 , A61B5/14532 , A61B5/1455 , A61B5/1495 , A61B5/7264
摘要： Methods and apparatus for estimating and removing spectral interference improve precision and robustness of non-invasive analyte measurement using Near-infrared (NIR) spectroscopy. The estimation of spectral interference is accomplished, either through multivariate modeling or discrete factor analysis, using a calibration set of samples in which the interference is orthogonal to the analyte signal of interest, or where the shape of the interference is known. Each of the methods results in a multivariate model in which the spectral interference is estimated for a new sample and removed by vector subtraction. Independent models based on classes of sample variability are used to collapse spectral interference and determine more accurately which model is best equipped to estimate the signal of interference in the new sample. Principal components analysis and other commonly known analytical techniques can be used to determine class membership.
摘要翻译：用于估计和去除光谱干扰的方法和装置使用近红外（NIR）光谱提高非侵入性分析物测量的精度和鲁棒性。通过多变量建模或离散因子分析，使用其中干涉与感兴趣的分析物信号正交的样本的校准集合或已知干扰的形状来完成频谱干扰的估计。每种方法都产生一个多变量模型，其中对新样本估计出光谱干扰，并通过向量减去去除。使用基于样本变异性类别的独立模型来折叠光谱干扰，并更准确地确定哪种模型最适合估计新样本中的干扰信号。主成分分析和其他常用分析技术可用于确定类成员资格。

9. 发明授权

US06475800B1 Intra-serum and intra-gel for modeling human skin tissue 失效
标题翻译：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。

10. 发明授权

US07606608B2 Optical sampling interface system for in-vivo measurement of tissue 有权
标题翻译：用于体内测量组织的光学取样界面系统
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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