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。

公开(公告)号：US07333843B2

公开(公告)日：2008-02-19

申请号：US10824459

申请日：2004-04-13

申请人： Stephen L. Monfre ,  George Acosta ,  Thomas B. Blank ,  Kevin H. Hazen

发明人： Stephen L. Monfre ,  George Acosta ,  Thomas B. Blank ,  Kevin H. Hazen

IPC分类号： A61B5/00

CPC分类号： A61B5/6841 ,  A61B5/14532 ,  A61B5/1455 ,  G01N21/359 ,  G01N21/474

摘要： A placement guide apparatus with an improved hydration inducing plug used in coupling a noninvasive analyzer to a sampling site to determine analyte in the human body is disclosed. The hydration inducing plug includes at least one fluoropolymer that may be used as a coupling agent. The guide apparatus may further include an automated or semi-automated coupling fluid delivery system. Use of either of these couplers mitigates issues associated with related technology and enhances noninvasive analyte measurements, such as a near-IR diffuse reflectance based noninvasive glucose concentration analyzer.

摘要翻译： 公开了一种具有改进的水合诱导塞的放置引导装置，其用于将非侵入性分析器耦合到取样部位以确定人体中的分析物。 水合诱导塞包括至少一种可用作偶联剂的含氟聚合物。 引导装置还可以包括自动化或半自动化耦合流体输送系统。 使用这些耦合剂中的任一种可减轻与相关技术相关的问题，并增强非侵入性分析物测量，例如基于近红外漫反射的非侵入性葡萄糖浓度分析仪。

公开(公告)号：US07299080B2

公开(公告)日：2007-11-20

申请号：US10820322

申请日：2004-04-07

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

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

IPC分类号： A61B5/00

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：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。

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。

公开(公告)号：US20080319382A1

公开(公告)日：2008-12-25

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： A61M37/00 ,  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。

公开(公告)号：US07133710B2

公开(公告)日：2006-11-07

申请号：US10472856

申请日：2003-03-07

申请人： George M. Acosta ,  James R. Henderson ,  N. Alan Abul Haj ,  Timothy L. Ruchti ,  Stephen L. Monfre ,  Thomas B. Blank ,  Kevin H. Hazen

发明人： George M. Acosta ,  James R. Henderson ,  N. Alan Abul Haj ,  Timothy L. Ruchti ,  Stephen L. Monfre ,  Thomas B. Blank ,  Kevin H. 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 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：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。

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。

公开(公告)号：US07505801B2

公开(公告)日：2009-03-17

申请号：US11848139

申请日：2007-08-30

申请人： Stephen L. Monfre ,  George M. Acosta ,  Thomas B. Blank ,  Kevin H. Hazen

发明人： Stephen L. Monfre ,  George M. Acosta ,  Thomas B. Blank ,  Kevin H. Hazen

IPC分类号： A61B5/1455

CPC分类号： A61B5/6841 ,  A61B5/14532 ,  A61B5/1455 ,  G01N21/359 ,  G01N21/474

摘要： A placement guide apparatus with an improved hydration inducing plug used in coupling a noninvasive analyzer to a sampling site to determine analyte in the human body is disclosed. The hydration inducing plug includes at least one fluoropolymer that may be used as a coupling agent. The guide apparatus may further include an automated or semi-automated coupling fluid delivery system. Use of either of these couplers mitigates issues associated with related technology and enhances noninvasive analyte measurements, such as a near-IR diffuse reflectance based noninvasive glucose concentration analyzer.

摘要翻译： 公开了一种具有改进的水合诱导塞的放置引导装置，其用于将非侵入性分析器耦合到取样部位以确定人体中的分析物。 水合诱导塞包括至少一种可用作偶联剂的含氟聚合物。 引导装置还可以包括自动化或半自动化耦合流体输送系统。 使用这些耦合剂中的任一种可减轻与相关技术相关的问题，并增强非侵入性分析物测量，例如基于近红外漫反射的非侵入性葡萄糖浓度分析仪。