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    • 1. 发明授权
    • Method for detecting artifacts in data
    • 检测数据中伪像的方法
    • US07254425B2
    • 2007-08-07
    • US10763548
    • 2004-01-23
    • Michael G. LoweryEric B. ShainOmar S. Khalil
    • Michael G. LoweryEric B. ShainOmar S. Khalil
    • A61B5/00
    • A61B5/1455A61B5/14532A61B5/14535A61B5/7207G01N21/49
    • A method for identifying artifacts occurring during a measurement of the concentration of an analyte in a biological sample by means of an apparatus that employs temperature-controlled optical probes, introduces electromagnetic radiation into tissue, and collects and detects radiation emitted at a distance from the point at which the electromagnetic radiation is introduced. The values of intensity of radiation emitted at different wavelengths, at different distances between the light introduction site(s) and the light collection site(s), and at different temperatures are collected and used in the method to generate a relationship between these values and the concentration of an analyte in the tissue or the disease state of a patient. The method involves the use of an algorithm that identifies artifacts in the data resulting from motion of the patient and allows the rejection of data sets that contain these artifacts. The algorithm identifies sudden changes in the magnitude and direction in a sequence of collected signals.
    • 一种用于识别通过使用温度控制的光学探针的装置测量生物样品中的分析物的浓度而发生的伪影的方法,将电磁辐射引入组织中,并且收集并检测距离该点 电磁辐射被引入。 收集在不同波长下,在光引入部位与光采集部位之间的不同距离以及不同温度下发射的辐射强度值,并用于该方法中以产生这些值与 组织中分析物的浓度或患者的疾病状态。 该方法涉及使用识别由患者运动产生的数据中的伪影的算法,并允许拒绝包含这些伪像的数据集。 该算法识别收集信号序列中的幅度和方向的突变。
    • 2. 发明授权
    • Method for optical measurements of tissue to determine disease state or concentration of an analyte
    • 用于光学测量组织以确定分析物的疾病状态或浓度的方法
    • US07167734B2
    • 2007-01-23
    • US09834440
    • 2001-04-13
    • Omar S. KhalilShu-jen YehStanislaw KantorCharles F. HannaEric B. Shain
    • Omar S. KhalilShu-jen YehStanislaw KantorCharles F. HannaEric B. Shain
    • A61B5/00
    • A61B5/1495A61B5/14532A61B5/1455A61B5/7264
    • A method for collecting optical data at two morphologically similar, substantially non-overlapping, and preferably adjacent, areas on the surface of a tissue, while the temperature in each area is being maintained or modulated according to a temperature program. The optical data obtained are inserted into a mathematical relationship, e.g., an algorithm, that can be used to predict a disease state (such as the diabetes mellitus disease state) or the concentration of an analyte for indicating a physical condition (such as blood glucose level). This invention can be used to differentiate between disease status, such as, for example, diabetic and non-diabetic. The method involves the generation of a calibration (or training) set that utilizes the relationship between optical signals emanating from the skin under different thermal stimuli and disease status, e.g., diabetic status, established clinically. This calibration set can be used to predict the disease state of other subjects. Structural changes, as well as circulatory changes, due to a disease state are determined at two morphologically similar, but substantially non-overlapping areas on the surface of human tissue, e.g., the skin of a forearm, with each area being subjected to different temperature modulation programs. In addition to determination of a disease state, this invention can also be used to determine the concentration of an analyte in the tissues. This invention also provides an apparatus for the determination of a disease state, such as diabetes, or concentration of an analyte, such as blood glucose level, by the method of this invention.
    • 一种用于在组织表面上的两个形态上类似的,基本上不重叠的,优选相邻的区域收集光学数据的方法,同时根据温度程序维持或调节每个区域中的温度。 所获得的光学数据被插入到数学关系中,例如算法,其可用于预测疾病状态(例如糖尿病状态)或用于指示身体状况的分析物的浓度(例如血糖 水平)。 本发明可用于区分疾病状况,例如糖尿病和非糖尿病。 该方法包括产生校准(或训练)组,其利用在不同热刺激下发生的光学信号与疾病状态(例如临床确立的糖尿病状态)之间的关系。 该校准集可用于预测其他受试者的疾病状态。 由于疾病状态引起的结构变化以及循环变化在人组织表面上的两个形态相似但基本上非重叠的区域确定,例如前臂的皮肤,每个区域经受不同的温度 调制程序。 除了确定疾病状态之外,本发明还可以用于确定组织中分析物的浓度。 本发明还提供了一种用于通过本发明的方法测定疾病状态的装置,例如糖尿病或分析物的浓度,例如血糖水平。
    • 9. 发明授权
    • Method and apparatus for obtaining blood for diagnostic tests
    • 血液检测方法及装置
    • US06206841B1
    • 2001-03-27
    • US09546948
    • 2000-04-11
    • David D. CunninghamTimothy P. HenningEric B. ShainDouglas F. YoungMichael G. LoweryThomas G. Schapira
    • David D. CunninghamTimothy P. HenningEric B. ShainDouglas F. YoungMichael G. LoweryThomas G. Schapira
    • A61B500
    • A61B5/15186A61B5/14532A61B5/1486A61B5/150022A61B5/150068A61B5/150076A61B5/150099A61B5/150221A61B5/150358A61B5/150412A61B5/150503A61B5/150664A61B5/15113A61B5/15125A61B5/1519A61B5/15194A61B5/157A61B5/411A61B2562/0295
    • Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and (b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises: (a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and (b) a vacuum pump. Preferably, the apparatus also includes a housing. In another aspect of this invention, an article is provided for an article capable of both collecting blood and detecting an analyte in that blood is provided. The article, which contains an appropriate detection element for determining the amount of analyte in the blood, can be used in conjunction with a meter that measures the signal generated by the detection element of the article. In one embodiment, the article is a multiple-layer element comprising: (a) a layer capable of receiving blood and transporting the blood received by means of chemically aided wicking; (b) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and (c) a layer that can be placed in contact with a meter, the meter-contactable layer overlying the blood-transporting layer, said layer (a) capable of transporting blood to said layer (b).
    • 用于从患者获得血样的方法和装置用于随后的诊断测试,例如葡萄糖监测。 在本发明的一个方面,所述方法包括以下步骤:(a)在要从其中提取血液样本的皮肤区域中形成无障碍的开口; 并且(b)借助于皮肤的真空和拉伸,从皮肤中的无障碍的开口提取血液样品。在本发明的另一方面,提供了一种用于执行前述方法的装置。 该装置包括:(a)用于在皮肤区域形成无障碍的开口的装置,所述皮肤区域将从所述皮肤区域中提取所述样品,优选为采血组件; 优选地,该装置还包括壳体。在本发明的另一方面,提供了一种能够收集血液并检测血液中的分析物的物品。 包含用于确定血液中分析物的量的合适的检测元件的物品可以与测量由物品的检测元件产生的信号的计量器结合使用。 在一个实施方案中,制品是多层元件,其包括:(a)能够接收血液并通过化学辅助芯吸输送接收到的血液的层;(b)能够检测分析物的存在或测量 血液中分析物的量; 以及(c)可以与仪表接触的层,覆盖在血液输送层上的可测量接触层,所述层(a)能够将血液输送到所述层(b)。
    • 10. 发明授权
    • Method and apparatus for obtaining blood for diagnostic tests
    • 血液检测方法及装置
    • US6071251A
    • 2000-06-06
    • US982323
    • 1997-12-02
    • David D. CunninghamTimothy P. HenningEric B. ShainDouglas F. YoungMichael G. LoweryThomas G. Schapira
    • David D. CunninghamTimothy P. HenningEric B. ShainDouglas F. YoungMichael G. LoweryThomas G. Schapira
    • A61B5/151A61B5/00A61B5/145A61B5/1459A61B5/1473A61B5/15A61B5/154A61B5/157G01N33/48G01N33/66
    • A61B5/15186A61B5/14532A61B5/1486A61B5/150022A61B5/150068A61B5/150076A61B5/150099A61B5/150221A61B5/150412A61B5/150503A61B5/150664A61B5/15113A61B5/15125A61B5/1519A61B5/15194A61B5/157A61B5/411A61B2562/0295A61B5/150358
    • Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:(a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and(b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin.In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises:(a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and(b) a vacuum pump.Preferably, the apparatus also includes a housing.In another aspect of this invention, an article is provided for an article capable of both collecting blood and detecting an analyte in that blood is provided. The article, which contains an appropriate detection element for determining the amount of analyte in the blood, can be used in conjunction with a meter that measures the signal generated by the detection element of the article. In one embodiment, the article is a multiple-layer element comprising:(a) a layer capable of receiving blood and transporting the blood received by means of chemically aided wicking;(b) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and(c) a layer that can be placed in contact with a meter, the meter-contactable layer overlying the blood-transporting layer, said layer (a) capable of transporting blood to said layer (b).
    • 用于从患者获得血样的方法和装置用于随后的诊断测试,例如葡萄糖监测。 在本发明的一个方面,所述方法包括以下步骤:(a)在要从其中提取血液样本的皮肤区域中形成无障碍的开口; 和(b)借助于真空和皮肤拉伸从皮肤中的无阻塞的开口提取血液样品。 在本发明的另一方面,提供一种用于执行前述方法的装置。 该装置包括:(a)用于在皮肤区域形成无障碍的开口的装置,所述皮肤区域将从所述皮肤区域中提取所述样品,优选为采血组件; 和(b)真空泵。 优选地,该装置还包括壳体。 在本发明的另一方面,提供了一种能够收集血液并检测血液中分析物的物品。 包含用于确定血液中分析物的量的合适的检测元件的物品可以与测量由物品的检测元件产生的信号的计量器结合使用。 在一个实施方案中,制品是多层元件,其包括:(a)能够接收血液并通过化学辅助芯吸运送接收的血液的层; (b)能够检测分析物的存在或测量血液中分析物的量的层; 以及(c)可以与仪表接触的层,覆盖在血液输送层上的可测量接触层,所述层(a)能够将血液输送到所述层(b)。