Abstract: In accordance with the invention, a low coherence interferometer is used to non-invasively monitor the concentration of glucose in blood by shining a light over a surface area of human or animal tissue, continuously scanning the light over a two dimensional area of the surface, collecting the reflected light from within the tissue and constructively interfering this reflected light with light reflected along a reference path to scan the tissue in depth. Since the reflection spectrum is sensitive to glucose concentration at particular wavelengths, measurement and analysis of the reflected light provides a measure of the level of glucose in the blood. The measurement of glucose is taken from multiple depths within blood-profused tissue, and sensitivity is preferably enhanced by the use of multiple wavelengths. Noise or speckle associated with this technique is minimized by continuously scanning the illuminated tissue in area and depth.

Abstract: Embodiments of methods of performing a structured collection protocol on a collection device comprise providing a plurality of prior biomarker samples, wherein the prior biomarker samples comprise at least one measured value and plurality of contextualized data components linked to the prior biomarker samples, setting a first criterion, wherein the first criterion classifies prior biomarker samples as similar if prior biomarker samples share at least one identical contextualized data component, grouping biomarker samples that are determined to be similar based on the first criterion, calculating expected values for future biomarker samples which satisfy the first criterion, wherein the calculation is based on at least a subset of the group of similar prior biomarker samples, setting a second criterion, wherein the second criterion is an acceptable variance from the calculated expected values, a threshold, or both, collecting one or more biomarker samples which satisfy the first criterion, and evaluating via t

Abstract: Optical coherence tomography (herein “OCT”) based analyte monitoring systems are disclosed. In one aspect, techniques are disclosed that can identify fluid flow in vivo (e.g., blood flow), which can act as a metric for gauging the extent of blood perfusion in tissue. For instance, if OCT is to be used to estimate the level of an analyte (e.g., glucose) in tissue, a measure of the extent of blood flow can potentially indicate the presence of an analyte correlating region, which would be suitable for analyte level estimation with OCT. Another aspect is related to systems and methods for scanning multiple regions. An optical beam is moved across the surface of the tissue in two distinct manners. The first can be a coarse scan, moving the beam to provide distinct scanning positions on the skin. The second can be a fine scan where the beam is applied for more detailed analysis.

Abstract: A pulse and active pulse spectraphotometry system comprises a light source adapted to illuminate a tissue site with optical radiation having a plurality of wavelengths selected from at least one of a primary band of about 1620 nm to about 1730 nm and a secondary band of about 1000 nm to about 1380 nm.

Abstract: Methods and systems for determining a physiological parameter of a subject through interrogation of an eye of the subject with an optical signal are described. Interrogation is performed unobtrusively. The system includes a gaze attractor for attracting the gaze of the subject to cause an eye of the subject to move into alignment with regard to an interrogation signal source and/or response signal sensor to facilitate detection of a signal from the eye of the subject.

Abstract: An in vivo component measurement method allowing how long a high concentration state of a measurement target component continues in an organism to be grasped is provided. In this in vivo component measurement method, a value relating to an amount of a measurement target component in tissue fluid extracted for 60 minutes or more from an organism on which a treatment for enhancing extraction of tissue fluid has been made is acquired.

Abstract: An optical measurement apparatus, to which a base end portion of a measurement probe introduced into a subject is connected so that scattering light from the subject through the measurement probe can be measured, includes: calibration member serving as an irradiation target of illumination light when a calibration process is performed for the measurement probe using the illumination light from the measurement probe; an insertion portion where a leading end of the measurement probe can be inserted; a housing portion that communicates with the insertion portion and accommodates the calibration member movably along a penetration direction of the insertion portion; a detection unit that detects insertion of the measurement probe when the calibration member reaches a predetermined position in the housing portion by the insertion of the measurement probe through the insertion portion; and a control unit that performs control for initiating the calibration process when the detection unit detects the insertion of the

Abstract: Embodiments of the present invention relates to analyte sensors. In particular, the preferred embodiments of the present invention relate to non-consuming intravascular glucose sensors based on fluorescence chemistry.

Abstract: Non-invasive apparatus and method for determining and monitoring glucose concentrations in human subjects. Glucose level is estimated through the effect of glucose on biological cells with glucose dependencies, e.g., red blood cells. The invention is based on the interaction of such cells with oscillating electric field gradients. The response of biological cells depends on factors including shape, size, and electrical charge distribution. The field gradient causes the cells to undergo characteristic motion which is detected by light beam scattering. The autocorrelation of the scattered light is computed, and the Fourier transform (FT) is performed to produce a characteristic velocity spectrum in which the peaks are characteristic of the cell “bio-electrical” states. The glucose level is estimated through measurements of changes of FT with changes in glucose levels after calibration with standard glucose methods.

Abstract: Disclosed are embodiments that relate to the deployment of a glucose sensor comprising an optical fiber into a physiological fluid, wherein the optical fiber has disposed along a distal region thereof a chemical indicator system comprising a fluorophore and a glucose binding moiety immobilized within a hydrogel, wherein the components of the chemical indicator system are in a dry state before deployment. Also disclosed is a one-point in vivo calibration of the chemical indicator system based on an independently measured glucose concentration.

Abstract: The invention comprises method and apparatus for fluid delivery between a sample probe and a sample. The fluid delivery system includes: a fluid reservoir, a delivery channel, a manifold or plenum, a channel or moat, a groove, and/or a dendritic pathway to deliver a thin and distributed layer of a fluid to a sample probe head and/or to a sample site. The fluid delivery system reduces sampling errors due to mechanical tissue distortion, specular reflectance, probe placement, and/or mechanically induced sample site stress/strain associated with optical sampling of the sample.

Abstract: Embodiments of the present invention relate to analyte sensors comprising a heparin coating, and methods of coating analyte sensors. The heparin can be stably associated with at least a portion of a porous membrane that covers a portion of the analyte sensors. The heparin can be photochemically linked to the coating through the formation of covalent bonds.

Abstract: A sensing apparatus for detecting light of first and second fluorescent wavelength bands has a light source to generate an excitation wavelength to a first collimator element. A dichroic multiplexer has a first coated surface oblique to the optical axis and treated to transmit the excitation wavelength and to reflect the second fluorescent wavelength band and a second coated surface treated to transmit the excitation wavelength and the second fluorescent wavelength band and to reflect the first fluorescent wavelength band. A focusing element focuses the excitation light toward a light guide and directs collimated light of the first and second fluorescent wavelength bands from the light guide to the dichroic multiplexer. A first detector element is in the path of reflected light of the first fluorescent wavelength band and a second detector element is in the path of reflected light of the second fluorescent wavelength band.

Abstract: The present invention provides a module for a computer interface including a transducer wherein the transducer receives a measurement value and makes this measurement value available for monitoring an individual's health by means of the computer interface, for example, for monitoring an individual's blood glucose level, wherein the measurement value is obtained by means of a sensor.

Abstract: Embodiments of the invention provide analyte sensors having optimized elements and/or configurations of elements as well as methods for making and using such sensors. Typical embodiments of the invention include glucose sensors used in the management of diabetes.

Abstract: Embodiments of the invention are directed to an optical sensor for detecting glucose. The sensor comprises a chemical indicator system disposed within a gap between the distal end of an optical fiber and an atraumatic tip portion, wherein the optical fiber and atraumatic tip portion are coupled by a coupling member, such as a rod or hypotube or cage that traverses the gap. The sensor further comprises a means for generating and detecting an optical reference signal unrelated to the glucose, such that ratiometric correction of glucose measurements for artifacts in the optical system is enabled.

Abstract: A sensor for the detection or measurement of carbohydrate analyte (such as glucose) in fluid comprises components of a competitive binding assay the readout of which is a detectable or measurable optical signal (such as FRET assay) retained by a material that permits diffusion of analyte but not the assay components, the assay components comprising: an animal lectin; and an analyte analogue capable of competing with analyte for binding to the lectin.

Abstract: A method for noninvasively measuring analyte levels includes using a non-imaging OCT-based system to scan a two-dimensional area of biological tissue and gather data continuously during the scanning. Structures within the tissue where measured-analyte-induced changes to the OCT data dominate over changes induced by other analytes are identified by focusing on highly localized regions of the data curve produced from the OCT scan which correspond to discontinuities in the OCT data curve. The data from these localized regions then can be related to measured analyte levels.

Abstract: A system, method and medical tool are presented for use in non-invasive in vivo determination of at least one desired parameter or condition of a subject having a scattering medium in a target region. The measurement system comprises an illuminating system, a detection system, and a control system. The illumination system comprises at least one light source configured for generating partially or entirely coherent light to be applied to the target region to cause a light response signal from the illuminated region. The detection system comprises at least one light detection unit configured for detecting time-dependent fluctuations of the intensity of the light response and generating data indicative of a dynamic light scattering (DLS) measurement. The control system is configured and operable to receive and analyze the data indicative of the DLS measurement to determine the at least one desired parameter or condition, and generate output data indicative thereof.

Abstract: A method of determining a measure of a tissue state (e.g., glycation end-product or disease state) in an individual is disclosed. A portion of the skin of the individual is illuminated with excitation light, then light emitted by the tissue due to fluorescence of a chemical with the tissue responsive to the excitation light is detected. The detected light can be combined with a model relating fluorescence with a measure of tissue state to determine a tissue state. The invention can illuminate the skin and detect responsive light over a time that spans a plurality of cardiac cycles of the individual, which can, as an example, help mitigate the effects of time-varying signals such as those due to hemoglobin. The invention can also determine the amount of light to be directed to the skin, for example by controlling the time that a light source is energized. The amount of illumination light can be determined from a skin reflectance characteristic such as pigmentation or melanin in the skin.

Abstract: A method for noninvasive blood glucose monitoring involves metabolic heat measurement and algorithm to correct interferences from environmental factors, and physiological or pathological conditions of subjects.

Abstract: Methods and systems for determining elapsed sensor life in medical systems, and more specifically continuous analyte monitoring systems.

Abstract: An infusion system that includes a controller device and a communication system to provide for two-way communication between the controller device and an infusion device that controls delivery of fluids to a user's body. Either the controller device or the infusion device may be integrated with a characteristic determining device in a single housing. The housing, in turn, may include a test-strip receptacle and an illuminator disposed so as to illuminate an area covering the receptacle and a test-strip inserted therein. The illuminator may be configured to be activated automatically when a test strip is inserted into the receptacle, selectively by the user via a button, key, or similar mechanism, and/or when the ambient light level, measured, e.g., with a light sensor, falls below a predetermined intensity. The illuminator may be a LED emitting white light, and may provide illumination at various levels of intensity.

Abstract: A method of non-invasive measurement of the glucose concentration directly in the blood flow utilizes a combination of the differential scattering spectroscopy and confocal scanning laser Doppler microscopy.

Abstract: Embodiments of the present invention are directed to an optical sensor capable of measuring two analytes simultaneously with a single indicator system. In preferred embodiments, the sensor comprises a fluorescent dye having acid and base forms that facilitate ratiometric pH sensing, wherein the dye is further associated with a glucose binding moiety and configured to generate a signal that varies in intensity with the concentration of glucose.

Abstract: Provided are a transmissive suction mechanism (1), a suction hole (5), provided in the suction mechanism (1), through which skin is pulled into the suction mechanism (1), and an exhaust hole (4), provided in the suction mechanism (1), through which air in the suction mechanism (1) is removed so as to reduce the pressure in the suction mechanism (1).

Abstract: Optical coherence tomography (herein “OCT”) based analyte monitoring systems are disclosed. In one aspect, techniques are disclosed that can identify fluid flow in vivo (e.g., blood flow), which can act as a metric for gauging the extent of blood perfusion in tissue. For instance, if OCT is to be used to estimate the level of an analyte (e.g., glucose) in tissue, a measure of the extent of blood flow can potentially indicate the presence of an analyte correlating region, which would be suitable for analyte level estimation with OCT. Another aspect is related to systems and methods for scanning multiple regions. An optical beam is moved across the surface of the tissue in two distinct manners. The first can be a coarse scan, moving the beam to provide distinct scanning positions on the skin. The second can be a fine scan where the beam is applied for more detailed analysis.

Abstract: This disclosure describes, among other features, systems and methods for customizing calibration curves, parameter algorithms, and the like to individual users. An initial calibration curve generated based on a population can be used as a starting point in an algorithm for measuring a physiological parameter such as glucose. The measurement algorithm can determine one or more initial measurement values for a user based on the initial calibration curve. In certain embodiments, one or more alternative measurements, such as invasive or minimally invasive measurements, can periodically or sporadically be input into the measurement algorithm. The algorithm can use the alternative measurements to adapt the calibration curve to the individual. As a result, measurements for the individual can more accurately reflect the individual's actual parameter values.

Abstract: Devices and methods are provided for continuous measurement of an analyte concentration. The device can include a sensor having a plurality of sensor elements, each having at least one characteristic that is different from other sensor(s) of the device. In some embodiments, the plurality of sensor elements are each tuned to measure a different range of analyte concentration, thereby providing the device with the capability of achieving a substantially consistent level of measurement accuracy across a physiologically relevant range. In other embodiments, the device includes a plurality of sensor elements each tuned to measure during different time periods after insertion or implantation, thereby providing the sensor with the capability to continuously and accurately measure analyte concentrations across a wide range of time periods.

Abstract: Devices and methods are provided for continuous measurement of an analyte concentration. The device can include a sensor having a plurality of sensor elements, each having at least one characteristic that is different from other sensor(s) of the device. In some embodiments, the plurality of sensor elements are each tuned to measure a different range of analyte concentration, thereby providing the device with the capability of achieving a substantially consistent level of measurement accuracy across a physiologically relevant range. In other embodiments, the device includes a plurality of sensor elements each tuned to measure during different time periods after insertion or implantation, thereby providing the sensor with the capability to continuously and accurately measure analyte concentrations across a wide range of time periods.

Abstract: A needle-type fluorescence sensor that measures glucose based on fluorescence produced by excitation light is provided. The needle-type fluorescence sensor includes a needle body section including a sensor portion disposed in a needle distal end portion and metal lines disposed from the sensor portion to a needle proximal end portion, and a connector which is integrated with the needle body section and in which the metal lines extend. The sensor portion includes a silicon substrate having first and second principal surfaces, a PD device that converts fluorescence into an electric signal, an LED device that transmits fluorescence and emits excitation light, and an indicator layer that interacts with an analyte under the excitation light to produce fluorescence. The PD device, the LED device, and the indicator layer overlap with each other above the first principal surface of the silicon substrate.

Abstract: Methods are provided for the detection of an analyte in a sample using wavelength modulated differential photothermal radiometry with enhanced sensitivity. A wavelength modulated differential photothermal radiometry system, comprising two optical modulated beams, where each beam experiences different absorption by the analyte, is calibrated by controlling the relative phase difference between the modulated beams so that individual photothermal signals corresponding to each modulated beam are 180° out of phase, corresponding to peak sensitivity to analyte concentration. The system may be further calibrated by varying the relative intensities of the two modulated beams and measuring standards containing known analyte concentration in order to determine an optimal relative intensity for a given concentration range of interest.

Abstract: A concentration measuring device, the measuring light in a wavelength region where an absorbance related to the water in the subject can be practically ignored is irradiated to the subject S by a light source. The transmitted light that was transmitted through the subject S is received in a light receiving part. An optical rotation calculation part calculates an optical rotation of the subject S by using an output signal from the light receiving part, and an absorbance calculation part calculates an absorbance of the subject S by using an output signal from the light receiving part. A concentration calculation part calculates a concentration of glucose by using a glucose measurement data related to an aqueous solution of simple glucose, a protein measurement data related to an aqueous solution of simple protein, the optical rotation calculated by the optical rotation calculation part, and the absorbance calculated by the absorbance calculation part.

Abstract: A non-invasive device for measuring concentration levels of optically active substances, such as glucose, by determination of polarization plane turn angle in the infrared spectrum. Instant embodiments, measuring optical polarization shift, include a narrow-band optical source having a first linear polarizer; substantially illuminated by the source, a sample stage capable of temporarily immobilizing a sample; proximate to the sample stage and within a predetermined angular range with respect to the source illumination of the sample, a narrow-band optical detector capable of detecting polarization angles from the illuminated sample; and in conjunction with the source and the detector, a linear polarization angle comparator for comparing a polarization of the source with a polarization maxima region measured by the detector.

Abstract: A system for in-place visualization of sensed data is provided. The system includes a formable sheet comprising a display and sensors embedded within the sheet underneath the display. The display will display information relating to sensed data on a portion of the display corresponding to locations of the sensors located underneath the display. As a result, the display displays the information above or directly above the sensors that output data.

Abstract: A blood component measuring device includes an irradiation light source configured to emit light at least in a near-infrared region, a light receiver having such sensitivity as to receive light emitted by the irradiation light source, a holding mechanism that holds and fixes a living body part, and an arithmetic device that calculates the concentration of a blood component in the living body part. The calculating means calculates the concentration of the blood component about, of the living body part, a place where the ratio of transmitted light intensity at a first wavelength relatively easily absorbed by hemoglobin and transmitted light intensity at a second wavelength relatively poorly absorbed by hemoglobin is the minimum.

Abstract: A used photoacoustic apparatus includes: a light source capable of individually emitting light having a first wavelength at which absorption coefficients of oxyhemoglobin and deoxyhemoglobin are equal and light having a second wavelength; an acoustic detector that receives acoustic waves generated when the light having the first and second wavelengths is absorbed by an object; an absorption coefficient distribution generator that determines absorption coefficient distributions of an object interior; a blood vessel position determining unit that determines a blood vessel position from an absorption coefficient distribution corresponding to the first wavelength; an organism characteristics distribution calculator that determines an organism characteristics distribution from the absorption coefficient distributions; and a trimming unit that trims the organism characteristics distribution in accordance with the blood vessel position.

Abstract: Methods, sensors, and systems for determining a concentration of glucose in a medium of a living animal are disclosed. Determining the glucose concentration may involve emitting excitation light from a light source to indicator molecules, generating a raw signal indicative of the amount of light received by a photodetector, purifying and normalizing the raw signal, and converting the normalized signal to a glucose concentration. The purification may involve removing noise (e.g., offset and/or distortion) from the raw signal. The purification and normalization may involve tracking the cumulative emission time that the light source has emitted the excitation light and tracking the implant time that has elapsed since the optical sensor was implanted. The purification and normalization may involve measuring the temperature of the sensor. The purification, normalization, and conversion may involve using parameters determined during manufacturing, in vitro testing, and/or in vivo testing.

Abstract: A method for achieving tight glycemic control in a patient in need thereof is disclosed. The method comprises deploying an equilibrium glucose sensor within a blood vessel in the patient, coupling the sensor to a monitor that displays the blood glucose concentration, and administering a blood glucose regulator when the blood glucose concentration varies outside of the predetermined concentration range. The blood glucose regulator is administered in an amount sufficient to return the blood glucose concentration to within the predetermined concentration range, thereby achieving tight glycemic control.

Abstract: A light absorption coefficient distribution estimation device includes a detection section and a light absorption coefficient distribution estimation section. The detection section detects the received light intensity of scattered light from a subject at a plurality of light-receiving positions that differ in distance from an irradiation position at which measurement light is applied to the subject. The light absorption coefficient distribution estimation section estimates the light absorption coefficient distribution of the subject using the received light intensity, a propagation optical path length model that specifies a propagation optical path length on a basis of the distance, and a first model that specifies the received light intensity on a basis of the distance when absorption of light is at a predetermined value.

Abstract: Disclosed herein is a packing container including: a packing container body including a leading-out section which contains an optical probe having a first end section for incoming of a laser beam and a second end section for outgoing of the incoming laser beam, which leads out the first end section of the optical probe thus contained to the exterior and which is sealed, and a window section by which the laser beam going out from the second end section of the contained optical probe is led out to the exterior; and a light-transmitting member which closes the window section and permits the laser beam to pass therethrough.

Abstract: Devices, systems, and methods for providing more accurate and reliable sensor data and for detecting sensor failures. Two or more electrodes can be used to generate data, and the data can be subsequently compared by a processing module. Alternatively, one sensor can be used, and the data processed by two parallel algorithms to provide redundancy. Sensor performance, including sensor failures, can be identified. The user or system can then respond appropriately to the information related to sensor performance or failure.

Abstract: A method of quantifying the amount of glucose in a sample is provided herein that may further comprise an interferent such as mannitol. At least two measurements are obtained using measurement methods that differ in their sensitivity to the amount of interferent in the sample, thus enabling the results to be compared to determine whether any interferent is present in the sample.

Abstract: The present invention relates to a sensor device for measuring tensile variation against a membrane separating a liquid such as the skin on humans and animals and any other membrane separating a liquid on one of its sides.

Abstract: Methods, sensors, and systems for determining a concentration of glucose in a medium of a living animal are disclosed. Determining the glucose concentration may involve emitting excitation light from a light source to indicator molecules, generating a raw signal indicative of the amount of light received by a photodetector, purifying and normalizing the raw signal, and converting the normalized signal to a glucose concentration. The purification may involve removing noise (e.g., offset and/or distortion) from the raw signal. The purification and normalization may involve tracking the cumulative emission time that the light source has emitted the excitation light and tracking the implant time that has elapsed since the optical sensor was implanted. The purification and normalization may involve measuring the temperature of the sensor. The purification, normalization, and conversion may involve using parameters determined during manufacturing, in vitro testing, and/or in vivo testing.

Abstract: A pulse and active pulse spectraphotometry system comprises a light source adapted to illuminate a tissue site with optical radiation having a plurality of wavelengths selected from at least one of a primary band of about 1620 nm to about 1730 nm and a secondary band of about 1000 nm to about 1380 nm.

Abstract: Provided are a measurement device by which the blood-sugar level or the like associated with the living activity of a diabetic patient can be measured easily and precisely and the measured valued associated with the living activity can be clinically applied easily, and an insulin infusion device, a measurement method, a method for controlling an insulin fusion device, and a program. A blood-sugar level measurement device (100) is provided with a blood-sugar level sensor (200) and an acceleration sensor (112) for measuring movement information associated with human body activity, wherein a CPU (110 controls, on the basis of the measured movement information, whether or not the measurement operation of a blood-sugar measurement circuit (113) can be executed.

Abstract: Methods and systems for providing data communication in medical systems are disclosed.

Abstract: Devices and methods for determining analyte levels are described. The devices and methods allow for the implantation of analyte-monitoring devices, such as glucose monitoring devices that result in the delivery of a dependable flow of blood to deliver sample to the implanted device. The devices include unique architectural arrangement in the sensor region that allows accurate data to be obtained over long periods of time.

Abstract: A blood constituent monitoring method for inducing an active pulse in the blood volume of a patient. The induction of an active pulse results in a cyclic, and periodic change in the flow of blood through a fleshy medium under test. By actively inducing a change of the blood volume, modulation of the volume of blood can be obtained to provide a greater signal to noise ratio. This allows for the detection of constituents in blood at concentration levels below those previously detectable in a non-invasive system. Radiation which passes through the fleshy medium is detected by a detector which generates a signal indicative of the intensity of the detected radiation. Signal processing is performed on the electrical signal to isolate those optical characteristics of the electrical signal due to the optical characteristics of the blood.