Abbott Laboratories Corporation

Toshiba Medical Systems Corporation

Kabushiki Kaisha Toshiba

Omar S Khalil

Charles F Hanna

Shu-jen Yeh

Xiaomao Wu

Tzyy-Wen Jeng

Stanislaw Kantor

Thomas F Zurek

Kurt M Klosterman

James L Dempski

Paul A Matuszewski

Jose Pioquinto

Johannes Sake Kanger

Frits Frans Maria De Mul

Shoichi Kanayama

Eric B Shain

Michael G Lowery

Kevin R Genger

Arnold F Stalder

Rene&prime; Alexander Bolt

Kazuhiro Itsumi

Gary M Oosta

Stanley R Bouma

Joseph Larry Pezzaniti

John M Lindberg

Edward K Pabich

Yi-Her Jou

Curtis J Pepe

Hugh W Graham

David C Wender

Ren&eacute; A Bolt

Denise G Huff

Carole L Coleman

Frits F M De Mul

Shu-Jen Yeh

Rene' Alexander Bolt

Ete Z Szuts

Denise A Grigalauski

Stephen M Cotter

Example apparatus and methods for use in normalization of testing machines used to test samples in vessels are disclosed. An example apparatus includes verification source and a photon emitter positioned in the verification source. The example photon emitter includes a Csource, a scintillator adjacent to the Csource, and a filter adjacent to the scintillator. The example photon emitter is to emit photons through the filter for detection by a photon counter.

Device for use in normalizing readings on a testing machine

An example optic module verification device for use in periodic normalization of a testing machine used to test samples in wells is disclosed. The example testing machine includes a plurality of photon counters that each count photons emitted from different wells. The example verification device includes a plurality of verification wells located so as to each be associated with one of the photon counters when used in the testing machine. The example device also includes a photon emitter in each verification well, each photon emitter including a Csource, a scintillator adjacent the Csource, and a filter over the scintillator. The example photon emitters each have a determined initial base value for emitted photons, and each photon emitter is positioned in its verification well to emit photons through the filter to the associated photon counter when used in the testing machine.

A method and apparatus for non-invasive measurement of living body information comprises a light source configured to generate light containing a specific wavelength component, an irradiation unit configured to irradiate a subject with the light, and at least one acoustic signal detection unit including piezoelectric devices formed of a piezoelectric single crystal containing lead titanate and configured to detect an acoustic signal which is generated due to the energy of the irradiation light absorbed by a specific substance present in or on a subject.

Method and apparatus for non-invasive measurement of living body characteristics by photoacoustics

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.

Method for noninvasive measurement of glucose and apparatus for noninvasive measurement of glucose

An optic module verification device for normalizing between X photon counters, including a verification tray with X verification wells and a modular photon emitter in each verification well. Each photon emitter includes a spring, a Beta source disk, a scintillator disk adjacent the Beta source disk, and a neutral density filter over the scintillator disk, all of which are encapsulated in a cylindrical chamber with the filter adjacent an opening on one end of the chamber and the spring biasing the Beta source disk and the scintillator disk toward the opening. The device is periodically used for normalization, and may be updated when emitted photons fall below a desired level by replacing the scintillator disk and then determining a new normalized reference values for each photon emitter.

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.

Method for detecting artifacts in data

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.

Method for optical measurements of tissue to determine disease state or concentration of an analyte

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, d, that is confined within a region in the sample wherein temperature is controlled. According to the method of this invention, the sampling depth d, 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 d. 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%.

Method for modulating light penetration depth in tissue and diagnostic applications using same

A method for the determination of hemoglobin and hematocrit by means of an apparatus that is capable of controlling the temperature of a defined subcutaneous volume of human skin. The method involves a calculation of hemoglobin concentration and hematocrit value that takes into consideration the values of optical parameters of the sample at various pre-set temperatures. The apparatus and method employ steady state optical measurements of samples, such as, for example, human tissue, by means of a reflectance tissue photometer and localized control of the temperature of the sample. According to the method of this invention, an optical signal from a defined subcutaneous volume of human skin is measured as the temperature of this volume is controlled. The method and apparatus of this invention allow determination of hemoglobin concentration and hematocrit value non-invasively in a population of subjects having different skin colors by means of steady state reflectance measurements. The method of this invention for determination of hemoglobin concentration and hematocrit value is useful for monitoring patients, testing at the point of care, and screening for anemia. In contrast to other attempts in the prior art that rely on signals of cardiac pulses, the method of this invention has the advantage for the determination of analytes in weak cardiac pulse situations, such as, for example, in elderly patients.

Method and device for the noninvasive determination of hemoglobin and hematocrit

Non-invasive sensor having controllable temperature feature

Method for improving non-invasive determination of the concentration of analytes in a biological sample

Method for non-invasively determining the concentration of an analyte by compensating for the effect of tissue hydration

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.

Non-invasive sensor capable of determining optical parameters in a sample having multiple layers

A method and apparatus for the measurement of trans-cutaneous diffuse reflectance at a single sampling distance for determining the concentration of an analyte in a biological sample, such as, for example, human tissue. The determination of the concentration of the analyte has been found to depend on the sampling distance and reaches an optimal result at a defined sampling distance for a given analyte and a given sample. The method involves measuring the light re-emitted from the sample at a distance from a light introduction site and correlating the intensity of the re-emitted light to the concentration of an analyte. For a given sample, the distance between the light collection site and a light introduction site (i.e., the sampling distance) corresponds to the depth from the surface into the sample at which scattering and absorption events significantly affect the intensity of re-emitted light (i.e., the sampling depth). Prior knowledge about the sample determines the optimal sampling depth for performing a measurement for a specific analyte and the corresponding sampling distance needed to reach that optimal sampling depth. Optimization of the sampling distance, as well as the correlation relationship, can be established in a calibration procedure.

Optical sensor having a selectable sampling distance for determination of analytes

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Chicago, IL, United States of America

Omar S Khalil