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1. 发明申请

US20090098587A1 METHOD OF SCREENING FOR DISORDERS OF GLUCOSE METABOLISM 审中-公开
标题翻译：葡萄糖代谢障碍筛查方法
公开(公告)号：US20090098587A1
公开(公告)日：2009-04-16
申请号：US12099740
申请日：2008-04-08
申请人： Donald Hetzel , Stephen L. Monfre , Kevin H. Hazen , Timothy L. Ruchti , Thomas B. Blank , Linda Hockersmith , Andrew Cone
发明人： Donald Hetzel , Stephen L. Monfre , Kevin H. Hazen , Timothy L. Ruchti , Thomas B. Blank , Linda Hockersmith , Andrew Cone
IPC分类号： C12Q1/54
CPC分类号： C12Q1/54 , A61B5/14532 , A61B5/7264 , G01N33/66 , G01N2800/042 , G16H50/20 , G16H50/70
摘要： A method of screening for disorders of glucose metabolism such as impaired glucose tolerance and diabetes allows prevention, or early detection and treatment of diabetic complications such as cardiovascular disease, retinopathy, and other disorders of the major organs and systems. A mathematical algorithm evaluates the shape of a subject's glucose profile and classifies the profile into one of several predefined clusters, each cluster corresponding either to a normal condition or one of several abnormal conditions. The series of blood glucose values making up the glucose tolerance curve may be measured using any glucose analyzer including: invasive, minimally invasive and noninvasive types. The method is executed on a processing device programmed to perform the steps of the method. Depending on the outcome of the screening, a subject may be provided with additional information concerning their condition and/or counseled to consult further with their health care provider.
摘要翻译：筛选葡萄糖代谢紊乱如葡萄糖耐量异常和糖尿病的方法允许预防或早期检测和治疗糖尿病并发症如心血管疾病，视网膜病变和主要器官和系统的其他病症。数学算法评估受试者的葡萄糖谱的形状并将轮廓分类为几个预定义的簇之一，每个簇对应于正常条件或几个异常条件之一。构成葡萄糖耐量曲线的一系列血糖值可以使用任何葡萄糖分析仪来测量，包括：侵入性，微创和非侵入性类型。该方法在被编程为执行该方法的步骤的处理装置上执行。根据筛查结果，可以向受试者提供有关其病情的信息和/或咨询，以进一步咨询其医护人员。

2. 发明授权

US07395158B2 Method of screening for disorders of glucose metabolism 失效
标题翻译：筛选葡萄糖代谢紊乱的方法
公开(公告)号：US07395158B2
公开(公告)日：2008-07-01
申请号：US10219200
申请日：2002-08-13
申请人： Stephen L. Monfre , Linda Hockersmith , Donald Hetzel , Kevin H. Hazen , Andrew Cone
发明人： Stephen L. Monfre , Linda Hockersmith , Donald Hetzel , Kevin H. Hazen , Andrew Cone
IPC分类号： G06F19/00 , G01N33/48
CPC分类号： A61B5/7264 , A61B5/14532 , Y10T436/144444
摘要： A method of screening for disorders of glucose metabolism such as impaired glucose tolerance and diabetes allows prevention, or early detection and treatment of diabetic complications such as cardiovascular disease, retinopathy, and other disorders of the major organs and systems. A mathematical algorithm evaluates the shape of a subject's glucose profile and classifies the profile into one of several predefined clusters, each cluster corresponding either to a normal condition or one of several abnormal conditions. The series of blood glucose values making up the glucose tolerance curve may be measured using any glucose analyzer including: invasive, minimally invasive and noninvasive types. The method is executed on a processing device programmed to perform the steps of the method. Depending on the outcome of the screening, a subject may be provided with additional information concerning their condition and/or counseled to consult further with their health care provider.
摘要翻译：筛选葡萄糖代谢紊乱如葡萄糖耐量异常和糖尿病的方法允许预防或早期检测和治疗糖尿病并发症如心血管疾病，视网膜病变和主要器官和系统的其他病症。数学算法评估受试者的葡萄糖谱的形状并将轮廓分类为几个预定义的簇之一，每个簇对应于正常条件或几个异常条件之一。构成葡萄糖耐量曲线的一系列血糖值可以使用任何葡萄糖分析仪来测量，包括：侵入性，微创和非侵入性类型。该方法在被编程为执行该方法的步骤的处理装置上执行。根据筛查结果，可以向受试者提供有关其病情的信息和/或咨询，以进一步咨询其医护人员。

3. 发明授权

US07698105B2 Method and apparatus for improving performance of noninvasive analyte property estimation 有权
标题翻译：用于改善非侵入性分析物质性能估计性能的方法和装置
公开(公告)号：US07698105B2
公开(公告)日：2010-04-13
申请号：US11168941
申请日：2005-06-27
申请人： Timothy L. Ruchti , Linda Hockersmith , Stephen L. Monfre , Kevin H. Hazen
发明人： Timothy L. Ruchti , Linda Hockersmith , Stephen L. Monfre , Kevin H. Hazen
IPC分类号： G06F11/00 , A61B5/00
CPC分类号： A61B5/1455 , A61B5/14532 , A61B2560/0223 , G01N21/359
摘要： The invention relates to noninvasive analyte property determination. More particularly, the invention relates to a method and apparatus for performing conditional additional acquisition of noninvasive spectra to improve analyzer performance. Conditional additional data acquisition is used to confirm, update, and/or supplement spectral data.
摘要翻译：本发明涉及非侵入性分析物质的测定。更具体地，本发明涉及用于执行非侵入性光谱的条件附加获取以提高分析仪性能的方法和装置。条件附加数据采集用于确认，更新和/或补充光谱数据。

4. 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。

5. 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。

6. 发明授权

US06487429B2 Use of targeted glycemic profiles in the calibration of a noninvasive blood glucose monitor 失效
公开(公告)号：US06487429B2
公开(公告)日：2002-11-26
申请号：US09766872
申请日：2001-01-18
申请人： Linda Hockersmith , Thomas B. Blank , Stephen L. Monfre , Timothy L. Ruchti
发明人： Linda Hockersmith , Thomas B. Blank , Stephen L. Monfre , Timothy L. Ruchti
IPC分类号： A61B500
CPC分类号： A61B5/14532
摘要： A method of calibrating a non-invasive blood glucose measurement instrument to a diabetic test subject employs targeted glycemic profiles in anti-correlated pairs. During calibration, reference blood glucose determinations are made using conventional invasive sampling methods. Concurrently, noninvasive spectral measurements are made using the noninvasive glucose monitor. Through controlled oral ingestion by the subject of calculated amounts of carbohydrate, the subject's blood glucose level is manipulated to mimic the patterns of the targeted profiles. During a first visit, a first profile of a pair is induced; during a second visit the inverse of the first profile is induced. The targeted profiles produce reference blood glucose values in which correlation to sampling factors is reduced or eliminated, thus the resulting calibration is correlated to glucose, and not to other analytes, sampling factors or environmental factors. A formula is provided for calculating the required amount of carbohydrate to ingest to induce a targeted glycemic profile in a test subject.

7. 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。

8. 发明申请

US20080319382A1 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：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。

9. 发明授权

US07133710B2 Compact apparatus for noninvasive measurement of glucose through near-infrared spectroscopy 有权
标题翻译：用于通过近红外光谱法无损测量葡萄糖的紧凑装置
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。

10. 发明授权

US07039446B2 Indirect measurement of tissue analytes through tissue properties 失效
标题翻译：通过组织特性间接测量组织分析物
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。

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