公开(公告)号：US20050020892A1

公开(公告)日：2005-01-27

申请号：US10820322

申请日：2004-04-07

申请人： George Acosta ,  James Henderson ,  N. Haj ,  Timothy Ruchti ,  Stephen Monfre ,  Thomas Blank ,  Kevin Hazen

发明人： George Acosta ,  James Henderson ,  N. Haj ,  Timothy Ruchti ,  Stephen Monfre ,  Thomas Blank ,  Kevin Hazen

IPC分类号： A61B5/00 ,  A61B5/103 ,  A61B5/107 ,  G01N21/35 ,  G01N21/47 ,  G01N21/49

CPC分类号： A61B5/1455 ,  A61B5/0075 ,  A61B5/1075 ,  A61B5/14532 ,  A61B5/1495 ,  A61B5/441 ,  A61B5/4869 ,  A61B5/4872 ,  A61B5/6824 ,  A61B5/7203 ,  A61B5/726 ,  A61B2560/0233 ,  A61B2562/0233 ,  A61B2562/0242 ,  G01N21/359 ,  G01N21/474 ,  G01N21/49

摘要： A near IR spectrometer-based analyzer attaches continuously or semi-continuously to a human subject and collects spectral measurements for determining a biological parameter in the sampled tissue, such as glucose concentration. The analyzer includes an optical system optimized to target the cutaneous layer of the sampled tissue so that interference from the adipose layer is minimized. The optical system includes at least one optical probe. Spacing between optical paths and detection fibers of each probe and between probes is optimized to minimize sampling of the adipose subcutaneous layer and to maximize collection of light backscattered from the cutaneous layer. Penetration depth is optimized by limiting range of distances between paths and detection fibers. Minimizing sampling of the adipose layer greatly reduces interference contributed by the fat band in the sample spectrum, increasing signal-to-noise ratio. Providing multiple probes also minimizes interference in the sample spectrum due to placement errors.

摘要翻译： 基于近红外光谱仪的分析仪连续或半连续地连接到人类受试者并且收集用于确定采样组织中的生物学参数（诸如葡萄糖浓度）的光谱测量。 该分析仪包括优化的靶向采样组织的皮肤层的光学系统，使得来自脂肪层的干扰最小化。 光学系统包括至少一个光学探针。 针对每个探针和探针之间的光路和检测纤维之间的间距进行优化，以最小化脂肪皮下层的取样，并最大限度地收集从皮肤层反射的光。 穿透深度通过限制路径和检测光纤之间的距离范围进行优化。 最小化脂肪层的取样大大减少了样品谱中脂肪带所造成的干扰，提高了信噪比。 提供多个探针也可以最小化由于放置误差而导致的样品光谱干扰。

公开(公告)号：US20050010090A1

公开(公告)日：2005-01-13

申请号：US10472856

申请日：2003-03-07

申请人： George Acosta ,  James Henderson ,  N. Abul Haj ,  Timothy Ruchti ,  Stephen Monfre ,  Thomas Blank ,  Kevin Hazen

发明人： George Acosta ,  James Henderson ,  N. Abul Haj ,  Timothy Ruchti ,  Stephen Monfre ,  Thomas Blank ,  Kevin Hazen

IPC分类号： A61B5/00 ,  A61B5/145 ,  A61B5/1455 ,  G01N21/49 ,  G01N33/48

CPC分类号： A61B5/1455 ,  A61B5/0075 ,  A61B5/14532 ,  A61B5/1495 ,  A61B5/6833 ,  A61B5/7203 ,  A61B5/7225 ,  A61B5/726 ,  A61B2560/0223 ,  A61B2560/0233 ,  A61B2560/0252 ,  A61B2560/0412 ,  A61B2560/0443 ,  A61B2560/0456 ,  A61B2562/0242 ,  A61B2562/146 ,  A61B2562/227 ,  A61B2562/228 ,  G01N21/359 ,  G01N21/49

摘要： The invention involves the monitoring of a biological parameter through a compact analyzer. The preferred apparatus is a spectrometer based system that is attached continuously or semi-continuously to a human subject and collects spectral measurements that are used to determine a biological parameter in the sampled tissue. The preferred target analyze is glucose. The preferred analyzer is a near-IR based glucose analyzer for determining the glucose concentration in the body.

摘要翻译： 本发明涉及通过紧凑型分析仪监测生物参数。 优选的装置是基于光谱仪的系统，其连续地或半连续地连接到人类受试者并收集用于确定采样组织中的生物学参数的光谱测量。 优选的目标分析是葡萄糖。 优选的分析仪是用于测定体内葡萄糖浓度的基于近红外的葡萄糖分析仪。

公开(公告)号：US20060211927A1

公开(公告)日：2006-09-21

申请号：US11328543

申请日：2006-01-09

申请人： George Acosta ,  James Henderson ,  N. Abul Haj ,  Timothy Ruchti ,  Stephen Monfre ,  Thomas Blank ,  Kevin Hazen

发明人： George Acosta ,  James Henderson ,  N. Abul Haj ,  Timothy Ruchti ,  Stephen Monfre ,  Thomas Blank ,  Kevin Hazen

IPC分类号： A61B5/00

CPC分类号： A61B5/1455 ,  A61B5/0075 ,  A61B5/14532 ,  A61B5/1495 ,  A61B5/6833 ,  A61B5/7203 ,  A61B5/7225 ,  A61B5/726 ,  A61B2560/0223 ,  A61B2560/0233 ,  A61B2560/0252 ,  A61B2560/0412 ,  A61B2560/0443 ,  A61B2560/0456 ,  A61B2562/0242 ,  A61B2562/146 ,  A61B2562/227 ,  A61B2562/228 ,  G01N21/359 ,  G01N21/49

摘要： The invention involves the monitoring of a biological parameter through a compact analyzer. The preferred apparatus is a spectrometer based system that is attached continuously or semi-continuously to a human subject and collects spectral measurements that are used to determine a biological parameter in the sampled tissue. The preferred target analyte is glucose. The preferred analyzer is a near-IR based glucose analyzer for determining the glucose concentration in the body.

公开(公告)号：US20050196821A1

公开(公告)日：2005-09-08

申请号：US11121207

申请日：2005-05-02

申请人： Stephen Monfre ,  Kevin Hazen ,  Timothy Ruchti ,  Thomas Blank ,  James Henderson

发明人： Stephen Monfre ,  Kevin Hazen ,  Timothy Ruchti ,  Thomas Blank ,  James Henderson

IPC分类号： A61B5/145 ,  A61B5/00 ,  A61B5/1455 ,  A61B5/1495 ,  G01N21/27 ,  G01N21/35 ,  G01N21/49 ,  C12Q1/54

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 uses 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 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.

公开(公告)号：US20050149300A1

公开(公告)日：2005-07-07

申请号：US10976530

申请日：2004-10-29

申请人： Timothy Ruchti ,  Alexander Lorenz ,  Kevin Hazen

发明人： Timothy Ruchti ,  Alexander Lorenz ,  Kevin Hazen

IPC分类号： A61B5/00 ,  G01N21/35 ,  G06F17/10

CPC分类号： A61B5/1455 ,  A61B5/14532 ,  A61B5/1495 ,  A61B2560/0223 ,  G01N21/359

摘要： The invention provides for 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. In a first embodiment of the invention, 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. In a second embodiment, each data matrix is independently preprocessed. Demonstration of the invention is performed through glucose concentration estimation from noninvasive spectra of the body.

摘要翻译： 本发明提供了数据块的一部分的变换，独立于单独或重叠的数据块的变换，以确定与原始矩阵相关的属性，其中分离的或重叠的数据块中的每一个从原始数据矩阵导出。 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。 在本发明的第一实施例中，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。 在第二实施例中，每个数据矩阵是独立预处理的。 本发明的演示通过来自身体的非侵入性光谱的葡萄糖浓度估计来进行。

公开(公告)号：US20050107676A1

公开(公告)日：2005-05-19

申请号：US10971447

申请日：2004-10-21

申请人： George Acosta ,  James Henderson ,  N. Abul-Haj ,  Timothy Ruchti ,  Stephen Monfre ,  Thomas Blank ,  Kevin Hazen

发明人： George Acosta ,  James Henderson ,  N. Abul-Haj ,  Timothy Ruchti ,  Stephen Monfre ,  Thomas Blank ,  Kevin Hazen

IPC分类号： A61B5/00

CPC分类号： A61B5/1455 ,  A61B5/14532 ,  A61B2560/0223 ,  A61B2560/0233

摘要： A near-infrared spectrometer-based analyzer attaches continuously or semi-continuously to a human subject and is used to collect spectral measurements of a tissue sample. The spectral readings are used to estimate a biological parameter in the sampled tissue noninvasively, such as glucose concentration. The preferred apparatus is a near-infrared analyzer that includes a base module and a sample module connected together with a communication bundle. The base module contains the bulk of the analyzer, such as a spectrograph and a central processing unit with an algorithm used for converting the optical signal into a glucose concentration. The sample module is typically in a smaller module that interfaces to a tissue sample. The sample module is preferably handheld and provides minimal sampling distortion due to heat or pressure.

摘要翻译： 基于近红外光谱仪的分析仪连续地或半连续地连接到人类受试者，并用于收集组织样本的光谱测量。 光谱读数用于非侵入性地估计采样组织中的生物学参数，如葡萄糖浓度。 优选的装置是近红外分析器，其包括与通信束连接在一起的基本模块和样本模块。 基本模块包含分析仪的大部分，例如光谱仪和具有用于将光信号转换为葡萄糖浓度的算法的中央处理单元。 样品模块通常在与组织样品接口的较小模块中。 样品模块优选是手持式的，并且由于热或压力而提供最小的采样失真。

公开(公告)号：US20160242682A1

公开(公告)日：2016-08-25

申请号：US14965807

申请日：2015-12-10

申请人： Sandeep Gulati ,  Timothy Ruchti ,  Kevin H. Hazen

发明人： Sandeep Gulati ,  Timothy Ruchti ,  Kevin H. Hazen

IPC分类号： A61B5/1455 ,  G01N21/41 ,  G01N21/359 ,  A61B5/145 ,  A61B5/00

CPC分类号： A61B5/1455 ,  A61B5/0022 ,  A61B5/1079 ,  A61B5/14532 ,  A61B5/14546 ,  A61B5/6801 ,  A61B5/7278 ,  G01J3/0218 ,  G01J3/2803 ,  G01J3/36 ,  G01J3/42 ,  G01N21/359 ,  G01N21/4795 ,  G01N2021/317 ,  G01N2021/4797 ,  G01N2201/062

摘要： A noninvasive analyzer apparatus and method of use thereof is described for spatially separating light having noninvasively probed a tissue volume into groups, which narrows standard deviations of probed tissue pathlength for each of the groups. Reduction in tissue pathlength uncertainty subsequently enhances noninvasive analyte concentration determination accuracy. Control of individual detector distance from an illumination zone in combination with control of area of a detection zone coupled to an individual detector yields intensity control of the various groups. The intensity control is optionally aided using several intensity control elements including: control of detector response shape, hardware gain settings set as function of distance from the illumination zone, varying numerical aperture of light collection optics as a function of position from the illumination zone, multiple illumination-detector linked bundlets, micro-optics, segmented spacers, arcs of detector elements, and/or outlier analysis based on detected intensity as a function of position.

摘要翻译： 描述了一种非侵入性分析仪装置及其使用方法，用于将具有非侵入式探测组织体积的光空间分离成组，其缩小了每个组的探测组织路径长度的标准偏差。 减少组织路径长度不确定性随后增强非侵入性分析物浓度测定精度。 与照明区域的单独检测器距离的控制与耦合到单独检测器的检测区域的面积的控制相结合，可以产生各组的强度控制。 强度控制可选择地使用几个强度控制元件辅助，包括：检测器响应形状的控制，设置为距离照明区域的距离的函数的硬件增益设置，作为来自照明区域的位置的函数的光收集光学器件的变化的数值孔径，多个 照明检测器连接的束，微光学，分段间隔物，检测器元件的弧和/或基于检测强度作为位置的函数的离群值分析。

公开(公告)号：US20160249836A1

公开(公告)日：2016-09-01

申请号：US14965782

申请日：2015-12-10

申请人： Sandeep Gulati ,  Timothy Ruchti ,  Kevin H. Hazen

发明人： Sandeep Gulati ,  Timothy Ruchti ,  Kevin H. Hazen

IPC分类号： A61B5/1455 ,  A61B5/145

CPC分类号： A61B5/1455 ,  A61B5/0022 ,  A61B5/1079 ,  A61B5/14532 ,  A61B5/6801 ,  G01J3/0218 ,  G01J3/2803 ,  G01J3/36 ,  G01J3/42 ,  G01N21/359 ,  G01N21/4795 ,  G01N2021/317 ,  G01N2021/4797 ,  G01N2201/062

摘要： A noninvasive analyzer apparatus and method of use thereof is described for spatially separating light for use in noninvasively determining an analyte concentration of a subject through use of detectors linked to multiple controlled sample illumination zone to sample detection zone distances. The controlled radial separation of illumination and detection zones yields reduced deviation in total observed optical pathlength and/or control of pathlengths in a desired tissue volume for each element of a set of detector elements. Performance using the discrete detection zones is enhanced using a combination of segmented spacers, arcs of detector elements, use of micro-optics, use of optical filters associated with individual detector elements, control of detector response shapes, and/or outlier analysis achievable through use of multiple separate and related observed signals of a detector array.

摘要翻译： 描述了一种非侵入性分析仪装置及其使用方法，用于通过使用与多个受控采样照射区域连接的检测器来采样检测区距离来非空间地确定受试者的分析物浓度，用于空间分离光。 照射和检测区域的受控径向分离在一组检测器元件的每个元件的期望组织体积中总观察光程长度和/或控制光程差减小。 使用分离的检测区域的性能被增强使用分段间隔物，检测器元件弧，使用微光学，使用与各个检测器元件相关联的滤光器，控制检测器响应形状和/或通过使用可实现的异常值分析 的检测器阵列的多个分离和相关的观察信号。

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。