Abstract: 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 C14 source, a scintillator adjacent to the C14 source, and a filter adjacent to the scintillator. The example photon emitter is to emit photons through the filter for detection by a photon counter.

Abstract: 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 C14 source, a scintillator adjacent to the C14 source, and a filter adjacent to the scintillator. The example photon emitter is to emit photons through the filter for detection by a photon counter.

Abstract: 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 C14 source, a scintillator adjacent the C14 source, 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.

Abstract: 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.

Abstract: 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.

Abstract: 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 C14 source, a scintillator adjacent the C14 source, 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: Devices and methods for non-invasively measuring at least one parameter of a sample, such as the presence or concentration of an analyte, in a body part wherein the temperature is controlled. The present invention measures light that is reflected, scattered, absorbed, or emitted by the sample from an average sampling depth, dav, that is confined within a temperature controlled region in the tissue. This average sampling depth is preferably less than 2 mm, and more preferably less than 1 mm. Confining the sampling depth into the tissue is achieved by appropriate selection of the separation between the source and the detector and the illumination wavelengths. In another aspect, the invention involves a method and apparatus for non-invasively measuring at least one parameter of a body part with temperature stepping. In another aspect, the invention involves a method and apparatus for non-invasively measuring at least one parameter of a body part with temperature modulation.

Abstract: 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.

Abstract: A method of monitoring a patient that comprises a non-invasive measurement of the hematocrit value or the concentration of hemoglobin coupled with the measurement of one or more vital signs. These vital signs include, but are not limited to, cardiac pulse rate, blood pressure, and arterial blood oxygenation. The invention also provides an apparatus for monitoring changes in the hematocrit value of a patient, in combination with one or more of the patient's vital signs.

Abstract: A method for determining the concentration of an analyte in tissues. The method involves compensating for a change in the value of an optical property of the tissues, such as, for example, the scattering coefficient, resulting from a change in the hydration status of the tissues.

Abstract: 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.