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1. 发明授权

US07043287B1 Method for modulating light penetration depth in tissue and diagnostic applications using same 有权
标题翻译：用于调节组织中的透光深度的方法和使用其的诊断应用
公开(公告)号：US07043287B1
公开(公告)日：2006-05-09
申请号：US09419461
申请日：1999-10-15
申请人： Omar S. Khalil , Shu-Jen Yeh , Xiaomao Wu , Stanislaw Kantor , Charles F. Hanna , Tzyy-Wen Jeng
发明人： Omar S. Khalil , Shu-Jen Yeh , Xiaomao Wu , Stanislaw Kantor , Charles F. Hanna , Tzyy-Wen Jeng
IPC分类号： A61B5/00
CPC分类号： A61B5/14532 , A61B5/0059 , A61B5/1455 , A61B5/1495 , A61B2562/0242
摘要： Devices and methods for non-invasively measuring at least one parameter of a sample, such as the presence of a disease condition, progression of a disease state, presence of an analyte, or concentration of an analyte, in a biological sample, such as, for example, a body part. In these devices and methods, temperature is controlled and is varied between preset boundaries. The methods and devices measure light that is reflected, scattered, absorbed, or emitted by the sample from an average sampling depth, dav, that is confined within a region in the sample wherein temperature is controlled. According to the method of this invention, the sampling depth dav, in human tissue is modified by changing the temperature of the tissue. The sampling depth increases as the temperature is lowered below the body core temperature and decreases when the temperature is raised within or above the body core temperature. Changing the temperature at the measurement site changes the light penetration depth in tissue and hence dav. Change in light penetration in tissue as a function of temperature can be used to estimate the presence of a disease condition, progression of a disease state, presence of an analyte, or concentration of an analyte in a biological sample. According to the method of this invention, an optical measurement is performed on a biological sample at a first temperature. Then, when the optical measurement is repeated at a second temperature, light will penetrate into the biological sample to a depth that is different from the depth to which light penetrates at the first temperature by from about 5% to about 20%.
摘要翻译：用于非侵入性地测量样品的至少一个参数的装置和方法，例如疾病状况的存在，疾病状态的进展，分析物的存在或分析物的浓度，例如，身体部位。在这些装置和方法中，控制温度并在预设的边界之间变化。方法和装置测量由样品中的平均采样深度d> av is is is is is is is measure measure measure measure measure measure measure measure measure measure measure measure measure measure measure or or wherein wherein wherein wherein wherein wherein。。。。。。。。根据本发明的方法，通过改变组织的温度来改变人体组织中的采样深度d>。。当温度降低到体芯温度以下时，采样深度增加，当温度升高到体芯内温度以上时，采样深度降低。改变测量部位的温度会改变组织中的光穿透深度，从而改变组织的光穿透深度。可以使用作为温度的函数的组织中的光穿透的变化来估计生物样品中疾病状况，疾病状态的进展，分析物的存在或分析物的浓度的存在。根据本发明的方法，在第一温度下对生物样品进行光学测量。然后，当在第二温度下重复光学测量时，光将穿透生物样品至与第一温度下的光渗透约5％至约20％的深度不同的深度。

2. 发明授权

US06654620B2 Method for improving non-invasive determination of the concentration of analytes in a biological sample 有权
标题翻译：改善生物样品中分析物浓度无创测定方法
公开(公告)号：US06654620B2
公开(公告)日：2003-11-25
申请号：US09835705
申请日：2001-04-16
申请人： Xiaomao Wu , Omar S. Khalil , Tzyy-Wen Jeng , Shu-Jen Yeh , Charles F. Hanna
发明人： Xiaomao Wu , Omar S. Khalil , Tzyy-Wen Jeng , Shu-Jen Yeh , Charles F. Hanna
IPC分类号： A61B550
CPC分类号： G01N21/4795 , A61B5/14532 , A61B5/14546 , A61B5/1455 , A61B5/1491 , A61B5/6824 , A61B2562/0233 , A61B2562/0242 , A61B2562/043
摘要： A method for determining the concentration of an analyte in a biological sample comprising the steps of: (1) providing an optical measuring instrument comprising a thermally controllable optical measuring element that comes into contact with the surface of the biological sample; (2) applying a coupling agent to the optical measuring element or to the surface of the biological sample or to both so that the coupling agent will be disposed at the interface of the surface of the biological sample and the optical measuring element; (3) measuring optical properties of the biological sample by means of the optical measuring instrument; and (4) correlating the optical properties of the biological sample with the concentration of the analyte in the biological sample. The coupling agent can be selected from the group consisting of silicone oil, mineral oil, polyethylene glycols, and oils from natural resources.
摘要翻译：一种用于确定生物样品中分析物浓度的方法，包括以下步骤：（1）提供光学测量仪器，其包括与生物样品表面接触的热可控光学测量元件;（2）偶联剂到光学测量元件或生物样品的表面或两者以使得偶联剂将被布置在生物样品的表面与光学测量元件的界面处;（3）测量光学特性通过光学测量仪器生物样品; 和（4）将生物样品的光学性质与生物样品中分析物的浓度相关联。偶联剂可以选自硅油，矿物油，聚乙二醇和来自天然资源的油。

3. 发明授权

US06241663B1 Method for improving non-invasive determination of the concentration of analytes in a biological sample 有权
公开(公告)号：US06241663B1
公开(公告)日：2001-06-05
申请号：US09302207
申请日：1999-04-29
申请人： Xiaomao Wu , Omar S. Khalil , Tzyy-Wen Jeng , Shu-Jen Yeh , Charles F. Hanna
发明人： Xiaomao Wu , Omar S. Khalil , Tzyy-Wen Jeng , Shu-Jen Yeh , Charles F. Hanna
IPC分类号： A61B500
CPC分类号： G01N21/4795 , A61B5/14532 , A61B5/14546 , A61B5/1455 , A61B5/1491 , A61B5/6824 , A61B2562/0233 , A61B2562/0242 , A61B2562/043
摘要： A method for determining the concentration of an analyte in a biological sample comprising the steps of: (1) providing an optical measuring instrument that comprises at least one thermally controllable optical measuring element that comes into contact with the surface of the biological sample; (2) applying an inert, thermally conductive, optically transparent coupling agent to the at least one optical measuring element or to the surface of the biological sample or both so that the coupling agent will be disposed at the interface of the surface of the biological sample and the at least one optical measuring element; (3) measuring optical properties of the biological sample by means of the optical measuring instrument; and (4) correlating the optical properties of the biological sample with the concentration of the analyte in the biological sample. A coupling agent suitable for this invention must have several properties to enable it to help decrease measurement variation, especially drift. One of the most important properties is sufficiently high optical stability that the optical properties of the coupling agent do not change even during prolonged experiments, such as oral glucose tolerance tests. Secondly, the coupling agent should have sufficiently high thermal conductivity to allow fast, efficient heat transfer between the optical probe and the biological sample. Third, the coupling agent should have sufficiently high viscosity to prevent it from migrating from the measurement area. Yet, it should also have sufficiently low viscosity to allow sufficient contact between the optical probe and the biological sample and to permeate into any small pockets between the probe and the biological sample that would otherwise be filled with the air. Fourth, the coupling agent should be inert. Material from the coupling agent should not diffuse into the biological sample and material from the biological sample should not diffuse into the coupling agent.

4. 发明授权

US6067463A Method and apparatus for non-invasively measuring the amount of glucose in blood 有权
标题翻译：用于非侵入性测量血液中葡萄糖量的方法和装置
公开(公告)号：US6067463A
公开(公告)日：2000-05-23
申请号：US225430
申请日：1999-01-05
申请人： Tzyy-Wen Jeng , Shu-Jen Yeh , John M. Lindberg , Joseph Larry Pezzaniti , Omar S. Khalil , Gary M. Oosta , Charles F. Hanna , Arnold F. Stalder , Ete Z. Szuts
发明人： Tzyy-Wen Jeng , Shu-Jen Yeh , John M. Lindberg , Joseph Larry Pezzaniti , Omar S. Khalil , Gary M. Oosta , Charles F. Hanna , Arnold F. Stalder , Ete Z. Szuts
IPC分类号： G01N21/35 , A61B5/00 , A61B5/145 , A61B5/1455
CPC分类号： A61B5/1455 , A61B5/14532
摘要： A method and apparatus for measuring the concentration of an analyte of interest, e.g. glucose, in blood non-invasively, i.e., without penetrating the skin or obtaining a biological sample from the body of a patient. The method and apparatus uses a plurality of measurement channels with appropriate wavelengths of interest to control variations of signal and to separate the contribution of the analyte of interest from those of interfering compounds. The method and apparatus of this invention can also be adapted to allow a portion of a body part to be engorged with blood to bring about greater accuracy in optical measurements. In the method of this invention, at least two similar, but not identical, measurements are made concurrently. For example, at least two measurements can be made with similar, but not identical, wavelengths of electromagnetic radiation. The two wavelengths should not be overlapping to allow maximum non-identity. By making measurements concurrently, each measurement channel in the system experiences variations as they occur substantially simultaneously in all channels. By selecting one of the channels as a reference channel and by normalizing the optical measurements of the other channels to this reference channel, the variations common to all channels are eliminated. Removing these common variations from the optical measurements by normalization, such as by calculating ratios of the measurement of each of the measuring channels to that of the reference channel, will allow the actual changes of the signal for a specific analyte of interest to be measured.
摘要翻译：用于测量所关注的分析物的浓度的方法和装置，例如，葡萄糖在血液中非侵入性地，即不渗透皮肤或从患者的身体获得生物样品。该方法和装置使用具有适当的感兴趣波长的多个测量通道来控制信号的变化并分离感兴趣分析物对干扰化合物的贡献。本发明的方法和装置还可以适于允许身体部分的一部分被血液吸收以在光学测量中带来更高的精度。在本发明的方法中，同时进行至少两个相似但不相同的测量。例如，可以用类似但不相同的电磁辐射波长进行至少两次测量。两个波长不应重叠，以允许最大的非身份。通过同时进行测量，系统中的每个测量通道在所有通道中基本上同时发生变化。通过选择一个通道作为参考通道，并将其他通道的光学测量标准化到该参考通道，可以消除所有通道共用的变化。通过归一化从光学测量中去除这些常见的变化，例如通过计算每个测量通道的测量与参考通道的测量的比率，将允许测量特定分析物的信号的实际变化。

5. 发明授权

US06630673B2 Non-invasive sensor capable of determining optical parameters in a sample having multiple layers 有权
公开(公告)号：US06630673B2
公开(公告)日：2003-10-07
申请号：US10036826
申请日：2001-12-21
申请人： Omar S. Khalil , Xiaomao Wu , Johannes Sake Kanger , Rene' Alexander Bolt , Shu-Jen Yeh , Charles F. Hanna , Frits Frans Maria de Mul
发明人： Omar S. Khalil , Xiaomao Wu , Johannes Sake Kanger , Rene' Alexander Bolt , Shu-Jen Yeh , Charles F. Hanna , Frits Frans Maria de Mul
IPC分类号： G01N2147
CPC分类号： A61B5/1455 , A61B5/14532 , A61B2562/0233 , A61B2562/0242 , A61B2562/043 , G01N21/49
摘要： Apparatus and method for non-invasively measuring at least one optical parameter of a sample, particularly a sample of tissue that comprises a plurality of layers. The at least one parameter can be used to determine the presence or concentration of an analyte of interest in the sample of tissue. The apparatus and method of the present invention (1) measure light that is substantially reflected, scattered, absorbed, or emitted from a shallower layer of the sample of tissue, (2) measure light that is substantially reflected, scattered, absorbed, or emitted from a deeper layer of the sample of tissue, (3) determine at least one optical parameter for each of these layers, and (4) account for the effect of the shallower layer on the at least one optical parameter of the deeper layer. Specifying the sampling depth allows determinations of the optical properties of a specific layer of the sample of the tissue, e.g., dermis, and decreases interference from other layers, e.g., stratum corneum and epidermis, in these determinations.

6. 发明授权

US06353226B1 Non-invasive sensor capable of determining optical parameters in a sample having multiple layers 有权
标题翻译：能够确定具有多层的样品中的光学参数的非侵入式传感器
公开(公告)号：US06353226B1
公开(公告)日：2002-03-05
申请号：US09198094
申请日：1998-11-23
申请人： Omar S. Khalil , Xiaomao Wu , Johannes Sake Kanger , Rene′ Alexander Bolt , Shu-Jen Yeh , Charles F. Hanna , Frits Frans Maria de Mul
发明人： Omar S. Khalil , Xiaomao Wu , Johannes Sake Kanger , Rene′ Alexander Bolt , Shu-Jen Yeh , Charles F. Hanna , Frits Frans Maria de Mul
IPC分类号： A61B500
CPC分类号： A61B5/1455 , A61B5/14532 , A61B2562/0233 , A61B2562/0242 , A61B2562/043 , G01N21/49
摘要： Apparatus and method for non-invasively measuring at least one optical parameter of a sample, particularly a sample of tissue that comprises a plurality of layers. The at least one parameter can be used to determine the presence or concentration of an analyte of interest in the sample of tissue. The apparatus and method of the present invention (1) measure light that is substantially reflected, scattered, absorbed, or emitted from a shallower layer of the sample of tissue, (2) measure light that is substantially reflected, scattered, absorbed, or emitted from a deeper layer of the sample of tissue, (3) determine at least one optical parameter for each of these layers, and (4) account for the effect of the shallower layer on the at least one optical parameter of the deeper layer. Specifying the sampling depth allows determinations of the optical properties of a specific layer of the sample of the tissue, e.g., dermis, and decreases interference from other layers, e. g., stratum corneum and epidermis, in these determinations.
摘要翻译：用于非侵入性地测量样品，特别是包括多个层的组织样品的至少一个光学参数的装置和方法。可以使用至少一个参数来确定组织样品中感兴趣的分析物的存在或浓度。本发明的装置和方法（1）测量从组织样本的较浅层基本反射，散射，吸收或发射的光，（2）测量基本上被反射，散射，吸收或发射的光从组织样本的较深层，（3）确定这些层中的每一层的至少一个光学参数，以及（4）考虑较浅层对较深层的至少一个光学参数的影响。指定采样深度允许确定组织样品（例如真皮）的特定层的光学性质，并减少来自其它层的干扰，例如，在这些决定中，例如角质层和表皮。

7. 发明授权

US08315681B2 Method for noninvasive measurement of glucose and apparatus for noninvasive measurement of glucose 有权
标题翻译：用于无创测量葡萄糖的方法和用于无创测量葡萄糖的装置
公开(公告)号：US08315681B2
公开(公告)日：2012-11-20
申请号：US12418899
申请日：2009-04-06
申请人： Shoichi Kanayama , Omar S. Khalil , Tzyy-Wen Jeng , Shu-Jen Yeh
发明人： Shoichi Kanayama , Omar S. Khalil , Tzyy-Wen Jeng , Shu-Jen Yeh
IPC分类号： A61B5/1455
CPC分类号： A61B5/1455 , A61B5/0053 , A61B5/14532 , A61B5/1491 , A61B5/1495 , A61B5/6824 , A61B5/6843
摘要： A method for noninvasive measurement of glucose in a tissue of a subject, including the steps of bringing an adaptation device, which has a shape similar to a measurement probe, into contact with a skin part of a subject for stretching the skin part of the subject under a pressure that is higher than a pressure per unit area applied by the measurement probe during the noninvasive measurement, maintaining the contact for a predetermined period of time followed by relieving the contact, bringing the measurement probe into contact with the stretched skin part of the subject for the noninvasive measurement, collecting signals emitted from the subject, and estimating a glucose concentration based on the collected signals.
摘要翻译：一种用于对受试者的组织中的葡萄糖进行非侵入性测量的方法，包括以下步骤：将具有与测量探针类似的形状的适应装置与受试者的皮肤部分接触以拉伸受试者的皮肤部分在非侵入性测量期间高于测量探针施加的每单位面积的压力的压力下，将接触保持预定的时间段，然后释放接触，使测量探针与被拉伸的皮肤部分接触主观无创测量，收集从受试者发射的信号，并根据收集的信号估计葡萄糖浓度。

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