Abstract: A contact lens having an integrated glucose sensor is provided. The contact lens includes an electrochemical sensor configured to measure the level of glucose in the tear fluid of the eye of the user wearing the contact lens. The electrochemical sensor is powered by radiation off-lens, through an RF antenna or a photovoltaic device mounted on the periphery of the contact lens. The power provided to the contact lens also enables transmission of data from the electrochemical sensor, for example by backscatter communications or optically by an LED mounted to the lens.

Abstract: A physiological measuring system is disclosed that monitors certain physiological parameters of an individual through the use of a body-mounted sensing apparatus. The apparatus is particularly adapted for continuous wear. The system is also adaptable or applicable to calculating derivations of such parameters. A oxygen debt measuring embodiment is directed predicting an outcome in response to injury and illness. The technique allows for closed-loop resuscitation, early identification of illness and early corrective action.

Abstract: Provided are methods of manufacturing a plurality of electrochemical sensors. The methods include forming a plurality of working electrodes on a first electrode region of a substrate, forming a plurality of counter electrodes on a second electrode region of the substrate, disposing a spacer layer on one of the first and second electrode regions, folding the substrate with the spacer layer between the first electrode region and the second electrode region to form a layered structure, and separating or cutting the layered structure to form individual electrochemical sensors.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Abstract: Portable device for the measurement and control of analytes in biological fluids, provided with biosensor for measurement and control of biological fluids such as glucose and other analytes characterized by the possibility of using electrolytic cells with two, three or more electrodes, with polarization voltage between a few millivolts and 100 millivolts; the possibility of measuring the fluid temperature at the outlet of the electrolytic cell in high resolution mode for diagnostic purposes, hence it can also be used for performing very accurate thermal compensation of the electrochemical measurement; the possibility of performing optimised correction of both the systematic and random errors in the measurement performed; the possibility of calibrating the sensors used more accurately and efficiently and, lastly, the possibility of performing the measurement with much lower polarization voltages at the electrodes than the equipment in the state of the art with consequent benefits in terms of reduced wear of th

Abstract: Systems and methods of use for continuous analyte measurement of a host's vascular system are provided. In some embodiments, a continuous glucose measurement system includes a vascular access device, a sensor and sensor electronics, the system being configured for insertion into communication with a host's circulatory system.

Abstract: An infusion set component for a fluid infusion device that delivers fluid to a patient is presented here. The component includes a tube formed from tubing material having an interior fluid canal defined therein to provide a fluid pathway from the fluid infusion device to the patient, a plurality of sensor conductors incorporated with the tubing material to facilitate sensing of an analyte of the patient by the fluid infusion device, and a combined infusion-sensor unit coupled to the tube and to the plurality of sensor conductors. The infusion-sensor unit accommodates delivery of fluid from the tube, and it also accommodates sensing of the analyte. The component may also include a connector assembly coupled to the tube and to the plurality of sensor conductors, to fluidly couple the fluid canal to a fluid reservoir of the fluid infusion device and to electrically couple the sensor conductors to an electronics module of the fluid infusion device.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor.

Abstract: A transdermal test sensor assembly adapted to determine an analyte concentration of a fluid sample is disclosed. The assembly comprises a sensor support including at least one reservoir adapted to hold a liquid. The assembly further comprises a test sensor being coupled to the sensor support. The test sensor forms at least one aperture therein. At least a portion of the at least one aperture is adjacent to the at least one reservoir. The assembly further comprises a hydrogel composition positioned on the test sensor. The hydrogel composition is linked to the at least one reservoir via the at least one aperture.

Abstract: A pH sensor includes an enclosed fluidic channel, an electrolyte solution within the fluidic channel, a first electrode exterior to the fluidic channel, a second electrode within the fluidic channel, a liquid junction extending between the fluidic channel and an exterior of the fluidic channel. The liquid junction is adapted to provide fluid connection between the electrolyte solution within the fluidic channel and an exterior of the fluidic channel. The pH sensor further includes a fluidic switch or fluidic controller in operative connection with the liquid junction to control whether the liquid junction provides fluid connection between the electrolyte solution within the fluidic channel and the exterior of the fluidic channel.

Abstract: Microbial fuel cells generate an electrical signal when microbes enter the cells through a semipermeable membrane. By reading and analyzing the signal from one or more such fuel cells can indicate infection in people or animals, indicate pathogens growing in food or show mold growth. Insofar as different microbes have specific metabolisms, the signal may be used to determine which microbe is present.

Abstract: Systems and methods for dynamically and intelligently estimating analyte data from a continuous analyte sensor, including receiving a data stream, selecting one of a plurality of algorithms, and employing the selected algorithm to estimate analyte values. Additional data processing includes evaluating the selected estimative algorithms, analyzing a variation of the estimated analyte values based on statistical, clinical, or physiological parameters, comparing the estimated analyte values with corresponding measure analyte values, and providing output to a user. Estimation can be used to compensate for time lag, match sensor data with corresponding reference data, warn of upcoming clinical risk, replace erroneous sensor data signals, and provide more timely analyte information encourage proactive behavior and preempt clinical risk.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: Methods and apparatus for providing data processing and control for use in a medical communication system are provided.

Abstract: A sensor array designed to be continuously indexed through a compatible blood glucose test monitor for the purpose of conducting multiple consecutive blood glucose measurements. The sensor array can be configured to substantially conform to a non-planar surface. In one embodiment, the sensor array includes first and second test sensors which are hingedly coupled together through a pin and socket interconnection. In another embodiment, the sensor array includes a unitary, non-conductive substrate which is scored to define one or more fold lines, a first set electrodes deposited on the substrate to define a first test sensor, and a second set of electrodes deposited on the substrate to define a second test sensor.

Abstract: Systems and methods for detecting noise episodes and processing analyte sensor data responsive thereto. In some embodiments, processing analyte sensor data includes filtering the sensor data to reduce or eliminate the effects of the noise episode on the signal.

Abstract: In certain embodiments, a method of maintaining health of a patient uses an analyte detection system. The analyte detection system is coupled to the patient such that a bodily fluid of the patient is accessible to the analyte detection system. The method includes automatically initiating and conducting a measurement of an analyte in the bodily fluid using the analyte detection system. The method further includes determining a treatment dose for the patient based on the measurement using the analyte detection system.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: The present invention relates generally to systems and methods for increasing oxygen availability to implantable devices. The preferred embodiments provide a membrane system configured to provide protection of the device from the biological environment and/or a catalyst for enabling an enzymatic reaction, wherein the membrane system includes a polymer formed from a high oxygen soluble material. The high oxygen soluble polymer material is disposed adjacent to an oxygen-utilizing source on the implantable device so as to dynamically retain high oxygen availability to the oxygen-utilizing source during oxygen deficits. Membrane systems of the preferred embodiments are useful for implantable devices with oxygen-utilizing sources and/or that function in low oxygen environments, such as enzyme-based electrochemical sensors and cell transplantation devices.

Abstract: The present invention relates generally to systems and methods for increasing oxygen availability to implantable devices. The preferred embodiments provide a membrane system configured to provide protection of the device from the biological environment and/or a catalyst for enabling an enzymatic reaction, wherein the membrane system includes a polymer formed from a high oxygen soluble material. The high oxygen soluble polymer material is disposed adjacent to an oxygen-utilizing source on the implantable device so as to dynamically retain high oxygen availability to the oxygen-utilizing source during oxygen deficits. Membrane systems of the preferred embodiments are useful for implantable devices with oxygen-utilizing sources and/or that function in low oxygen environments, such as enzyme-based electrochemical sensors and cell transplantation devices.

Abstract: A sampling device for sampling body fluid includes a lancet for making an incision, a capillary tube for drawing-up body fluid from the incision, and a test strip affixed to an upper end of the capillary tube for receiving the fluid. An absorbent pad can be disposed between the test strip and capillary tube for spreading-out the fluid being transferred to the test strip. An on-site analyzer such as an optical analyzer and/or an electrochemical analyzer can be mounted in the device for analyzing the fluid. Alternatively, a test strip can be slid through a slot formed in the bottom end of the device so that by passing the device against the skin after an incision has been formed, the test strip will directly contact body fluid emanating from the incision.

Abstract: A system and method for calibrating a sensor of a characteristic monitoring system in real time utilizes a self-calibration module for periodic determination of, and compensation for, the IR drop across unwanted resistances in a cell. A current-interrupt switch is used to open the self-calibration module circuit and either measure the IR drop using a high-frequency (MHz) ADC module, or estimate it through linear regression of acquired samples of the voltage across the sensor's working and reference electrodes (Vmeasured) over time. The IR drop is then subtracted from the closed-circuit value of Vmeasured to calculate the overpotential that exists in the cell (Vimportant). Vimportant may be further optimized by subtracting the value of the open-circuit voltage (Voc) across the sensor's working and reference electrodes. The values of Vmeasured and Vimportant are then controlled by respective first and second control units to compensate for the IR drop.

Abstract: Disclosed herein are systems and methods for calibrating a continuous analyte sensor, such as a continuous glucose sensor. One such system utilizes one or more electrodes to measure an additional analyte. Such measurements may provide a baseline or sensitivity measurement for use in calibrating the sensor. Furthermore, baseline and/or sensitivity measurements may be used to trigger events such as digital filtering of data or suspending display of data.

Abstract: Sensors and methods for producing them are disclosed. A cavity is created and filled with a reagent that includes a conductive matrix, enzyme, catalyst, and binding agent, in a preferred embodiment. The cavity is substantially enclosed, leaving enough of an opening to allow the sample to enter. A portion of the material surrounding the cavity is preferably permeable to a substance useful for measuring reaction, but not to the reagent or the sample. Cavities that have the shape of a cone, conical frustum, pyramidal frustum, and right circular cylinder are given as examples. Other systems include a membrane that contains the sensor's active area and defines an internal volume of fluid, where the membrane or internal volume has a particular geometric relationship to the active area.

Abstract: An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices.

Abstract: A medical device includes a connector which contacts a sensor to electrically connect the sensor with a measurement circuit in a medical device, a contact terminal which constitutes the connector, and a slide pin which ejects the sensor out of the medical device. The slide pin performs the operation of pushing up the contact terminal contacting the sensor as well as the operation of pushing the sensor out of the medical device. Since the contact terminal is completely lifted up by the inclined surface of the upper end part of the slide pin before the sensor is discarded, there occurs no reaction due to rebound of the contact terminal which might occur at the moment when the contact terminal of the connector is separated from the sensor, and thereby the sensor can be discarded so as to fall freely.

Abstract: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Abstract: Systems and methods for dynamically and intelligently estimating analyte data from a continuous analyte sensor, including receiving a data stream, selecting one of a plurality of algorithms, and employing the selected algorithm to estimate analyte values. Additional data processing includes evaluating the selected estimative algorithms, analyzing a variation of the estimated analyte values based on statistical, clinical, or physiological parameters, comparing the estimated analyte values with corresponding measure analyte values, and providing output to a user. Estimation can be used to compensate for time lag, match sensor data with corresponding reference data, warn of upcoming clinical risk, replace erroneous sensor data signals, and provide more timely analyte information encourage proactive behavior and preempt clinical risk.

Abstract: A sensor module (130) for a catheter (110), the sensor module (130) comprising a biofilm detection unit (131) adapted for detecting a characteristic of a biofilm (132) and electric circuitry (135, 800) for providing an output signal indicative of a result of the detection.

Abstract: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for processing sensor data, including calculating a rate of change of sensor data and/or determining an acceptability of sensor or reference data.

Abstract: An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices.

Abstract: A wearable, conductive textile patch is provided that may include any of a number of features for monitoring body analytes and/or delivering fluids to a body. In one embodiment of the invention, a single, patch-mounted system monitors glucose levels of a diabetic person and provides appropriate doses of insulin in response to the glucose measurements. A hand-held user interface can be provided for wirelessly controlling the system and/or receiving information from it. Conductive pathways can be formed in the fabric of the patch. Components that can be integrated into the flexible patch include a power source, controller, transmitter, antenna, temperature and other sensors, fluid pump, infusion set, electrical pathways, switches, controls, electrodes, connectors, resistors and other circuit elements. Such components can be embedded, interwoven or coated on to the flexible patch instead of or in addition to surface mounting. Methods associated with use of the flexible patch system are also covered.

Abstract: Embodiments of the invention provide amperometric analyte sensors having optimized elements such as electrodes formed from sputtered platinum compositions as well as layers of material selected to optimize the characteristics of a wide variety of sensor elements and sensors. While embodiments of the innovation can be used in a variety of contexts, typical embodiments of the invention include glucose sensors used in the management of diabetes.

Abstract: Systems and methods for minimizing or eliminating transient non-glucose related signal noise due to non-glucose rate limiting phenomenon such as ischemia, pH changes, temperatures changes, and the like. The system monitors a data stream from a glucose sensor and detects signal artifacts that have higher amplitude than electronic or diffusion-related system noise. The system replaces some or the entire data stream continually or intermittently including signal estimation methods that particularly address transient signal artifacts. The system is also capable of detecting the severity of the signal artifacts and selectively applying one or more signal estimation algorithm factors responsive to the severity of the signal artifacts, which includes selectively applying distinct sets of parameters to a signal estimation algorithm or selectively applying distinct signal estimation algorithms.

Abstract: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: Systems and methods for continuous measurement of an analyte in a host are provided. The system generally includes a continuous analyte sensor configured to continuously measure a concentration of analyte in a host and a sensor electronics module physically connected to the continuous analyte sensor during sensor use, wherein the sensor electronics module is further configured to directly wirelessly communicate displayable sensor information to a plurality of different types of display devices.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: The invention relates to a transdermal analyte monitoring system comprising a medium adapted to interface with a biological membrane and to receive an analyte from the biological membrane and an electrode assembly comprising a plurality of electrodes, wherein the medium is adapted to react continuously with the analyte, an electrical signal is detected by the electrode assembly, and the electrical signal correlates to an analyte value. The analyte value may be the flux of the analyte through the biological membrane or the concentration of the analyte in a body fluid of a subject. The medium may comprise a vinyl acetate based hydrogel, an agarose based hydrogel, or a polyethylene glycol diacrylate (PEG-DA) based hydrogel, for example. The surface region of the electrode may comprise pure platinum. The system may include an interference filter located between the biological membrane and the electrode assembly for reducing interference in the system.

Abstract: A blood sensor comprises a substrate, a spacer attached to the top of the substrate, a cover attached to the top of the spacer. A blood reservoir defined by a substrate hole formed in the substrate. A part of a spacer hole in the spacer and connected to the substrate hole, and a cover hole formed in the cover is connected to the spacer hole. A supply passage is defined by another part of the spacer hole that communicates with the blood reservoir portion, and detection electrodes are formed in the supply passage. The cover projects from the supply passage toward the inside of the blood reservoir portion farther than the substrate and the spacer.

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 network for monitoring bodily functions of a patient is disclosed. The network comprises at least two distinct network nodes that can be connected to a body of the patient. At least two of the network nodes can have at least one medical function, such as, for example, a diagnostic function and/or a medication function. The network nodes can communicate directly with one another via the body of the patient and can interchange data and/or commands.

Abstract: Method and apparatus for optimizing analyte sensor calibration including receiving a current blood glucose measurement, retrieving a time information for an upcoming scheduled calibration event for calibrating an analyte sensor, determining temporal proximity between the current blood glucose measurement and the retrieved time information for the upcoming calibration event, initiating a calibration routine to calibrate the analyte sensor when the determined temporal proximity is within a predetermined time period, and overriding the upcoming scheduled calibration event using the current blood glucose measurement are provided.

Abstract: The invention relates to a method for calibrating an analyte-measurement device that is used to evaluate a concentration of analyte in bodily fluid at or from a measurement site in a body. The method involves measuring a concentration, or calibration concentration, of an analyte in blood from an “off-finger” calibration site, and calibrating the analyte-measurement device based on that calibration concentration. The invention also relates to a device, system, or kit for measuring a concentration of an analyte in a body, which employs a calibration device for adjusting analyte concentration measured in bodily fluid based on an analyte concentration measured in blood from an “off-finger” calibration site.

Abstract: The invention relates to a method for calibrating an analyte-measurement device that is used to evaluate a concentration of analyte in bodily fluid at or from a measurement site in a body. The method involves measuring a concentration, or calibration concentration, of an analyte in blood from an “off-finger” calibration site, and calibrating the analyte-measurement device based on that calibration concentration. The invention also relates to a device, system, or kit for measuring a concentration of an analyte in a body, which employs a calibration device for adjusting analyte concentration measured in bodily fluid based on an analyte concentration measured in blood from an “off-finger” calibration site.

Abstract: Systems and methods for dynamically and intelligently estimating analyte data from a continuous analyte sensor, including receiving a data stream, selecting one of a plurality of algorithms, and employing the selected algorithm to estimate analyte values. Additional data processing includes evaluating the selected estimative algorithms, analyzing a variation of the estimated analyte values based on statistical, clinical, or physiological parameters, comparing the estimated analyte values with corresponding measure analyte values, and providing output to a user. Estimation can be used to compensate for time lag, match sensor data with corresponding reference data, warn of upcoming clinical risk, replace erroneous sensor data signals, and provide more timely analyte information encourage proactive behavior and preempt clinical risk.

Abstract: Methods and apparatuses for determining an analyte value are disclosed.

Abstract: Methods and apparatuses for determining an analyte value are disclosed.