公开(公告)号：WO2006093816A3

公开(公告)日：2006-09-08

申请号：PCT/US2006/006496

申请日：2006-02-24

Applicant: SENSYS MEDICAL, INC.

Inventor： MONFRE, Stephen, L. ,  BLANK, Thomas, B. ,  HAZEN, Kevin, H. ,  ABUL-HAJ, Alan ,  RUCHTI, Timothy, L. ,  HENDERSON, James, Ryan ,  STIPPICK, Tim ,  ABUL-HAJ, Roxanne

IPC: A61B5/00

Abstract: The invention provides a targeting system used to direct a measuring system to a targeted sample site or volume. The targeting system increases analyte estimation performance by increasing precision and accuracy of sampling and/or by targeting an analyte rich tissue volume.

公开(公告)号：WO2006062750A1

公开(公告)日：2006-06-15

申请号：PCT/US2005/042738

申请日：2005-11-23

Applicant: SENSYS MEDICAL, INC.

Inventor： BLANK, Thomas ,  ACOSTA, George ,  MATTU, Mutua ,  MAKAREWICZ, Marcy ,  MONFRE, Stephen, L. ,  LORENZ, Alexander, D. ,  RUCHTI, Timothy, L. ,  HAZEN, Kevin, H. ,  BERRY, Donovan, D. ,  ABUL-HAJ, Roxanne, E.

IPC: A61B5/00

CPC classification number: G01N21/359 ,  A61B5/14532 ,  A61B5/1455 ,  A61B5/1495 ,  A61B5/6833

Abstract: 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.

Abstract translation: 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导致的误差。 本发明的实施例使用引导件，该引导件进行以下操作中的至少一个：引起组织弯月面的形成，最小化由于表面不规则性引起的干扰，控制组织采样体积的变化，使用两部分引导系统， 控制样本探针的旋转并允许探针的z轴移动，使用单独的基本模块和样本模块与导向装置一起使用，并使用控制旋转的导向装置。 可选组件包括闭塞元件和偶联液。

公开(公告)号：WO2006047273A2

公开(公告)日：2006-05-04

申请号：PCT/US2005/037860

申请日：2005-10-20

Applicant: SENSYS MEDICAL, INC. ,  ACOSTA, George, M. ,  ABUL-HAJ, N., Alan ,  RUCHTI, Timothy, L. ,  MONFRE, Stephen, L. ,  BLANK, Thomas, B. ,  HAZEN, Kevin, H.

Inventor： ACOSTA, George, M. ,  ABUL-HAJ, N., Alan ,  RUCHTI, Timothy, L. ,  MONFRE, Stephen, L. ,  BLANK, Thomas, B. ,  HAZEN, Kevin, H.

IPC: A61B5/00

CPC classification number: A61B5/1455 ,  A61B5/14532 ,  A61B2560/0223 ,  A61B2560/0233

Abstract: A near-infrared spectrometer-based analyzer attaches continuously or semi­continuously 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.

Abstract translation: 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：WO2006091911A2

公开(公告)日：2006-08-31

申请号：PCT/US2006/006770

申请日：2006-02-22

Applicant: SENSYS MEDICAL, INC.

Inventor： BLANK, Thomas, B. ,  MATTU, Mutua ,  HENDERSON, James ,  HAZEN, Kevin, H. ,  ABUL-HAJ, Roxanne

IPC: A61B5/00

CPC classification number: A61B5/6842 ,  A61B5/14532 ,  A61B5/6841 ,  A61B2562/187

Abstract: The invention provides an adaptive mount for use in coupling a noninvasive analyte property analyzer to a living tissue sample site. The adaptive mount increases precision and accuracy of sampling by relieving stress and strain on a sample prior to and/or during sampling, which results in noninvasive analyte property estimations with corresponding performance enhancement.

Abstract translation: 本发明提供了一种用于将非侵入性分析物质分析仪与生物体组织样品位点连接的自适应装置。 自适应底座通过在采样之前和/或采样期间减轻样品的应力和应变来增加采样的精度和精度，这导致具有相应性能增强的非侵入性分析物质估计。

公开(公告)号：WO2005067788A1

公开(公告)日：2005-07-28

申请号：PCT/US2004/041878

申请日：2004-12-08

Applicant: SENSYS MEDICAL, INC.

Inventor： HOCKERSMITH, Linda ,  MONFRE, Stephen, L. ,  HAZEN, Kevin, H. ,  BLANK, Thomas, B.

IPC: A61B5/00

CPC classification number: A61B5/14532 ,  A61B2560/0223 ,  G01N33/66 ,  G01N33/6893 ,  G01N2800/042

Abstract: The invention provides a method of determining an individual's glucose metabolism sensitivity based upon the shape of a glucose profile in response to a stimulus, such as a caloric challenge. The sensitivity of an individual may be used to project a glucose response profile or to achieve a targeted response in the individual's blood glucose concentrations in response to a stimulus, such as medication, exercise, or caloric intake. An actual glucose response to a stimulus is determined using parameters that measure the shape of a glucose profile resulting from the stimulus. The glucose response provides rapid feedback of an individual's diabetic state.

Abstract translation: 本发明提供了一种基于响应刺激（例如卡路里刺激）的葡萄糖曲线的形状来确定个体的葡萄糖代谢敏感性的方法。 个体的敏感性可用于预测葡萄糖反应曲线或实现个体的血糖浓度响应刺激（例如药物，运动或卡路里摄入）的目标反应。 使用测量由刺激产生的葡萄糖分布形状的参数来确定对刺激的实际葡萄糖响应。 葡萄糖反应提供个人糖尿病状态的快速反馈。

公开(公告)号：WO2004043230A2

公开(公告)日：2004-05-27

申请号：PCT/US2003/035547

申请日：2003-11-06

Applicant: SENSYS MEDICAL, INC.

Inventor： HETZEL, Donald ,  MONFRE, Stephen, L. ,  HAZEN, Kevin, H. ,  RUCHTI, Timothy, L. ,  BLANK, Thomas, B. ,  HOCKERSMITH, Linda ,  CONE, Andrew

IPC: A61B

CPC classification number: C12Q1/54 ,  A61B5/14532 ,  A61B5/7264 ,  G01N33/66 ,  G01N2800/042 ,  G06F19/00 ,  G16H50/20 ,  G16H50/70

Abstract: 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 subjects’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.

Abstract translation: 筛选葡萄糖代谢障碍例如葡萄糖耐量受损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，例如心血管疾病，视网膜病和其他主要器官疾病，和 系统。 数学算法评估受试者葡萄糖谱的形状，并将该谱分类成几个预定义簇中的一个，每个簇对应于正常情况或几种异常情况之一。 构成葡萄糖耐量曲线的一系列血糖值可使用任何葡萄糖分析仪测量，所述葡萄糖分析仪包括：侵入性，微创和非侵入性类型。 该方法在编程为执行该方法的步骤的处理装置上执行。 根据筛查的结果，可向受试者提供关于他们的状况的额外信息和/或被建议与他们的卫生保健提供者进一步进行磋商。

公开(公告)号：WO2005122880A3

公开(公告)日：2005-12-29

申请号：PCT/US2005/019347

申请日：2005-06-02

Applicant: SENSYS MEDICAL, INC. ,  MONFRE, Stephen, L. ,  HAZEN, Kevin, H.

Inventor： MONFRE, Stephen, L. ,  HAZEN, Kevin, H.

IPC: A61B5/00

Abstract: The invention involves a kit for use in conjunction with a near-infrared, noninvasive glucose concentration analyzer. The preferred kit contains a set of elements used in preparation of a sample site and/or for use in a sampling process. The invention comprises a kit that includes any of a guide, a plug, an adhesive, an alignment tool, a cleaner, contact fluid, and a package for use in combination with a noninvasive glucose concentration analyzer.

公开(公告)号：WO2005104806A2

公开(公告)日：2005-11-10

申请号：PCT/US2005/015164

申请日：2005-04-28

Applicant: SENSYS MEDICAL, INC.

Inventor： BLANK, Thomas, B. ,  ACOSTA, George, M. ,  RUCHTI, Timothy, L. ,  MATTU, Mutua ,  LORENZ, Alexander, D. ,  HAZEN, Kevin, H. ,  HENDERSON, James, R.

IPC: A61B5/00 ,  G01N21/35

CPC classification number: A61B5/1455 ,  A61B5/14532 ,  A61B5/1495 ,  A61B5/4869 ,  A61B2560/0223 ,  A61B2560/0233 ,  A61B2562/0242 ,  G01N21/359

Abstract: A method and apparatus are provided for noninvasive sampling. More particularly, the method and apparatus relate to control of motion of an optical sample probe interface relative to a tissue sample site. A dynamic probe interface, is used to collect spectra of a targeted sample, control positioning of the sample probe relative to the tissue sample in terms of at least one of x-, y-, and z-axes, and/or control of sample tissue displacement to minimize spectral variations resulting from the sampling process and increase analyte property estimation precision and accuracy.

Abstract translation: 提供了一种用于无创采样的方法和装置。 更具体地，该方法和装置涉及光学样本探针界面相对于组织样本位点的运动的控制。 使用动态探针接口来收集目标样品的光谱，根据x-，y-和z-轴中的至少一个来控​​制样品探针相对于组织样品的定位和/或样品的控制 组织位移以最小化由采样过程导致的频谱变化，并增加分析物质的估计精度和精度。

公开(公告)号：WO2005027152A2

公开(公告)日：2005-03-24

申请号：PCT/US2004/028509

申请日：2004-08-31

Applicant: SENSYS MEDICAL, INC.

Inventor： KINCAID, Stephen ,  ACOSTA, George, M. ,  ABUL-HAJ, Roxanne ,  HAZEN, Kevin, H.

IPC: H01F

CPC classification number: F04B9/02 ,  A61B5/14532 ,  F04B17/00 ,  G01N21/49 ,  H01H3/34 ,  H01H36/0073

Abstract: A magnetic field based mechanical apparatus is disclosed. The apparatus is based on coupled attracting or opposing magnets in conjunction with the insertion or removal of a magnetic field modifier. In the preferred embodiment, two repelling magnets are drawn together with the insertion of a magnetic field modifier. The field modifier may be another magnet having an opposing pole. Removal of the field modifier returns the forces to their original states. This oscillating motion may be driven with a low energy and/or small power supply. The resulting motion of the opposing magnets can drive mechanical system such as a linear, gear, ratchet, or reciprocating drive.

Abstract translation: 公开了一种基于磁场的机械装置。 该装置基于耦合的吸引或相对的磁体与磁场修改器的插入或移除相结合。 在优选实施例中，两个排斥磁体一起插入磁场调节器。 场修正器可以是具有相对极的另一个磁体。 删除字段修饰符将力转移到其原始状态。 这种振荡运动可以用低能量和/或小的电源来驱动。 所产生的对置磁体的运动可以驱动诸如线性，齿轮，棘轮或往复驱动的机械系统。

公开(公告)号：WO2003076893A2

公开(公告)日：2003-09-18

申请号：PCT/US2003/006426

申请日：2003-03-03

Applicant: SENSYS MEDICAL, INC.

Inventor： MONFRE, Stephen, L. ,  HAZEN, Kevin, H. ,  RUCHTI, Timothy, L. ,  BLANK, Thomas, B. ,  HENDERSON, James, R.

IPC: G01N

CPC classification number: A61B5/1455 ,  A61B5/14532 ,  A61B5/1495 ,  G01N21/274 ,  G01N21/359 ,  G01N21/49

Abstract: 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.

Abstract translation: 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的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。