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1. 发明授权

US06640117B2 Method and apparatus for minimizing spectral effects attributable to tissue state variations during NIR-based non-invasive blood analyte determination 有权
标题翻译：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。

2. 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。

3. 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.

4. 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.

5. 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。

6. 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。

7. 发明授权

US07519406B2 Noninvasive analyzer sample probe interface method and apparatus 有权
标题翻译：无创分析仪样品探针接口方法和装置
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。

8. 发明授权

US07183102B2 Apparatus using reference measurement for calibration 失效
标题翻译：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。

9. 发明授权

US06998247B2 Method and apparatus using alternative site glucose determinations to calibrate and maintain noninvasive and implantable analyzers 失效
标题翻译：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。

10. 发明授权

US08504128B2 Method and apparatus for coupling a channeled sample probe to tissue 有权
标题翻译：用于将通道样品探针耦合到组织的方法和装置
公开(公告)号：US08504128B2
公开(公告)日：2013-08-06
申请号：US12109224
申请日：2008-04-24
申请人： Thomas B. Blank , Stephen L. Monfre , Kevin H. Hazen , Timothy L. Ruchti , Christopher Slawinski , Sedar R. Brown
发明人： Thomas B. Blank , Stephen L. Monfre , Kevin H. Hazen , Timothy L. Ruchti , Christopher Slawinski , Sedar R. Brown
IPC分类号： A61B5/1455
CPC分类号： G01N21/359 , A61B5/14532 , A61B5/1455 , A61B2562/146
摘要： Sampling is controlled in order to enhance analyte concentration estimation derived from noninvasive sampling. More particularly, sampling is controlled using controlled fluid delivery to a region between a tip of a sample probe and a tissue measurement site. The controlled fluid delivery enhances coverage of a skin sample site with the thin layer of fluid. Delivery of contact fluid is controlled in terms of spatial delivery, volume, thickness, distribution, temperature, and/or pressure.
摘要翻译：控制采样以增强从无创采样得到的分析物浓度估计。更具体地，使用受控流体输送到样品探针的尖端和组织测量部位之间的区域来控制取样。受控的流体输送增强了皮肤样品位点与薄层流体的覆盖。在空间传送，体积，厚度，分布，温度和/或压力方面控制接触流体的传送。

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