公开(公告)号：US20050054908A1

公开(公告)日：2005-03-10

申请号：US10841200

申请日：2004-05-06

申请人： Thomas Blank ,  Stephen Monfre ,  Marcy Makarewicz ,  Mutua Mattu ,  Kevin Hazen ,  James Henderson

发明人： Thomas Blank ,  Stephen Monfre ,  Marcy Makarewicz ,  Mutua Mattu ,  Kevin Hazen ,  James Henderson

IPC分类号： A61B5/00 ,  G01N21/27 ,  G01N21/35 ,  A61B6/00

CPC分类号： A61B5/1455 ,  A61B5/0075 ,  A61B5/14532 ,  A61B5/1491 ,  A61B2562/146 ,  G01N21/274 ,  G01N21/359

摘要： A method and apparatus using photo-stimulation to treat or pretreat a sample site prior to analyte concentration determination is presented. More particularly, photo-stimulation at or near at least one sample site is used to enhance perfusion of the sample site leading to reduced errors associated with sampling. Increased perfusion of the sample site leads to increased volume percentages of the target analyte and/or allows the blood or tissue constituent concentrations to more accurately and/or precisely track corresponding sample constituents in more well perfused body compartments or sites such as arteries, veins, or fingertips. In one embodiment, analysis of the photo-stimulated site is used in conjunction with glucose analyzers to determine the analyte concentration with greater ease, accuracy, or precision and may allow determination of the analyte concentration of another non-sampled body part or compartment.

摘要翻译： 提出了使用光刺激在分析物浓度测定之前处理或预处理样品位点的方法和装置。 更具体地，使用至少一个样品位点处或附近的光刺激来增强样品位点的灌注，导致与采样相关的减少的误差。 样品位点的增加的灌注导致目标分析物的体积百分比增加和/或允许血液或组织成分浓度更准确地和/或精确地跟踪更好灌注的身体隔室或部位如动脉，静脉中的相应样品组分， 或指尖。 在一个实施方案中，将光刺激位点的分析与葡萄糖分析仪结合使用以更容易，准确或精确地确定分析物浓度，并且可以允许确定另一非取样体部分或隔室的分析物浓度。

公开(公告)号：US20050203359A1

公开(公告)日：2005-09-15

申请号：US11008001

申请日：2004-12-08

申请人： Thomas Blank ,  George Acosta ,  Mutua Mattu ,  Marcy Makarewicz ,  Stephen Monfre ,  Alexander Lorenz ,  Timothy Ruchti ,  Kevin Hazen ,  Donovan Berry ,  Roxanne Abul-Haj

发明人： Thomas Blank ,  George Acosta ,  Mutua Mattu ,  Marcy Makarewicz ,  Stephen Monfre ,  Alexander Lorenz ,  Timothy Ruchti ,  Kevin Hazen ,  Donovan Berry ,  Roxanne Abul-Haj

IPC分类号： A61B5/00 ,  G01N21/35

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。

公开(公告)号：US20070060805A9

公开(公告)日：2007-03-15

申请号：US10917802

申请日：2004-08-12

申请人： Thomas Blank ,  George Acosta ,  Mutua Mattu ,  Marcy Makarewicz ,  Stephen Monfre ,  Alexander Lorenz ,  Timothy Ruchti

发明人： Thomas Blank ,  George Acosta ,  Mutua Mattu ,  Marcy Makarewicz ,  Stephen Monfre ,  Alexander Lorenz ,  Timothy 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.

摘要翻译： 光采样接口系统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。 组件包括：具有孔的光学探针放置引导件，其中接收光学探针，在组织测量位置的表面上促进对表面组织具有最小的，可重复的干扰的可重复放置精度。 孔径产生组织弯月面，其最小化由于表面不规则性引起的干扰并控制采集的组织体积的变化; 放置在组织半月板上方的闭塞元件将半月板与环境波动隔离，稳定了现场的水化，从而表现出张力; 光学耦合介质消除皮肤表面和光学探针之间的气隙; 偏置校正元件对光谱测量和相关的分析物测量应用偏差校正。 当导向器被更换时，新的偏置校正被确定用于新放置的测量。 可以单独部署系统的单独组件。

公开(公告)号：US20080200783A9

公开(公告)日：2008-08-21

申请号：US10384049

申请日：2003-03-07

申请人： Thomas Blank ,  Timothy Ruchti ,  Mutua Mattu ,  Marcy Makarewicz ,  Stephen Monfre ,  Alexander Lorenz

发明人： Thomas Blank ,  Timothy Ruchti ,  Mutua Mattu ,  Marcy Makarewicz ,  Stephen Monfre ,  Alexander Lorenz

IPC分类号： A61B5/00

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。

公开(公告)号：US20050049466A1

公开(公告)日：2005-03-03

申请号：US10917802

申请日：2004-08-12

申请人： Thomas Blank ,  George Acosta ,  Mutua Mattu ,  Marcy Makarewicz ,  Stephen Monfre ,  Alexander Lorenz ,  Timothy Ruchti

发明人： Thomas Blank ,  George Acosta ,  Mutua Mattu ,  Marcy Makarewicz ,  Stephen Monfre ,  Alexander Lorenz ,  Timothy Ruchti

IPC分类号： A61B5/01 ,  A61B20060101 ,  A61B1/00 ,  A61B5/00 ,  A61B5/0205 ,  A61B5/145 ,  A61B5/1455 ,  A61K9/00 ,  G01N21/01 ,  G01N21/35

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.

摘要翻译： 光采样接口系统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。 组件包括：具有孔的光学探针放置引导件，其中接收光学探针，在组织测量位置的表面上促进对表面组织具有最小的，可重复的干扰的可重复放置精度。 孔径产生组织弯月面，其最小化由于表面不规则性引起的干扰并控制采集的组织体积的变化; 放置在组织半月板上方的闭塞元件将半月板与环境波动隔离，稳定了现场的水化，从而表现出张力; 光学耦合介质消除皮肤表面和光学探针之间的气隙; 偏置校正元件对光谱测量和相关的分析物测量应用偏差校正。 当导向器被更换时，新的偏置校正被确定用于新放置的测量。 可以单独部署系统的单独组件。

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。

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.

公开(公告)号：US06839584B2

公开(公告)日：2005-01-04

申请号：US09954856

申请日：2001-09-17

申请人： Marcy Makarewicz ,  Mutua Mattu ,  Thomas B. Blank ,  George Acosta ,  Edward Handy ,  William Hay ,  Timothy Stippick ,  Benjamin Richie

发明人： Marcy Makarewicz ,  Mutua Mattu ,  Thomas B. Blank ,  George Acosta ,  Edward Handy ,  William Hay ,  Timothy Stippick ,  Benjamin Richie

IPC分类号： A61B20060101 ,  A61B5/00

CPC分类号： A61B5/14532 ,  A61B5/061 ,  A61B5/1459 ,  A61B5/6824 ,  A61B2562/146

摘要： An apparatus and method for reproducibly interfacing a living tissue sample to the measurement probe of a spectrometer instrument in-situ minimizes spectral interference related to sampling variations. A minimal contact subject interface includes supports replaceably mounted on a base. An optical coupling means, such as a fiber optic probe, contacts the measurement site through a probe aperture in the base. During use, a subject rests an extremity on the support elements, so that the extremity is reproducibly positioned and supported in relation to the optical coupling means. The supports have a small contact area, minimizing contact with the skin at the measurement site. The interface module is adjustable to fit any subject.By reproducibly positioning and supporting the body appendage using minimal contact supports, spectral interference due to variations in placement, applied pressure, and temperature transients secondary to contact with the interface module are greatly minimized.

摘要翻译： 将生物组织样本可再现地将光谱仪器的测量探针接地的设备和方法原位最小化与采样变化相关的光谱干扰。 最小接触主体界面包括可替换地安装在基座上的支撑件。 诸如光纤探针的光学耦合装置通过基座中的探针孔接触测量部位。 在使用期间，被摄体将支撑元件的末端置于支撑元件上，使得末端相对于光耦合装置可再现地定位和支撑。 支架具有很小的接触面积，使测量点与皮肤接触最小化。 接口模块是可调整的，适合任何物体。通过使用最小的接触支持可重复地定位和支撑身体附件，由于与接口模块接触的位置变化，施加的压力和温度瞬变引起的频谱干扰大大降低。

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。

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.