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: 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 of use involving sensors having a particle-containing domain are provided for continuous analyte measurement in a host. In some embodiments, a continuous analyte measurement system is configured to be wholly, transcutaneously, intravascularly or extracorporeally implanted.

Abstract: Systems and methods for processing sensor analyte data are disclosed, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. The sensor can be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. Reference data resulting from benchtop testing an analyte sensor prior to its insertion can be used to provide initial calibration of the sensor data. Reference data from a short term continuous analyte sensor implanted in a user can be used to initially calibrate or update sensor data from a long term continuous analyte sensor.

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: A membrane electrode includes a novel sensor combining a filtering function of a membrane and a signal measuring ability of an electrode. A target material may be measured by filtration through the membrane. A small amount of target materials may be detected with high sensitivity using an amplified electrical signal by increasing electrical conductivity by reducing metal ions on the membrane, and thus the target material may be subject to quantitative analysis. In addition, only a target material selectively binding to a receptor may be filtrated by passing a sample through the membrane after a receptor material is fixed to the electrode, and thus may be used to detect an electrical signal. In addition, the sensor may measure a signal in various methods such as electrical conductivity, impedance, etc.

Abstract: Apparatus for eliciting a blood sample comprises: a housing; a shaft mounted within the housing; an aperture in the housing, the aperture being configured to receive a part of a user; a member rotatably mounted on the shaft; a lancet protruding from one position at an edge of the member, and a blood collection part located at a second, different position at the edge of the member. The apparatus is configured such that: when the member is in a first rotational position the lancet is shielded by the housing, when the member is in a second rotational position the lancet is operable to lance the part of the user received at the aperture, and when the member is in a third rotational position the blood collection part is presented such as to receive blood from the part of the user received at the aperture.

Abstract: A remotely interrogatable pressure and/or temperature measuring device includes at least an acoustic wave sensor including at least one resonator coupled to a first antenna element, and an interrogation system including a second antenna element for transmission and reception. The device further includes an expandable tubular structure, the structure integrating a biocompatible material, and the acoustic wave sensor is encapsulated in the biocompatible material. The second antenna element operates at frequencies above several tens of MegaHertz.

Abstract: Systems and methods of use involving sensors having a particle-containing domain are provided for continuous analyte measurement in a host. In some embodiments, a continuous analyte measurement system is configured to be wholly, transcutaneously, intravascularly or extracorporeally implanted.

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

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: Implantable self-calibrating biosensor Subcutaneously or intracorporeally implantable biosensor, characterized by a closed microfluidic circuit with calibrating fluids, which communicates by a backward micro-dialysis logic with the exterior of said circuit, an open and in contact with the tissues and the interstitial fluid working electrode, for its self-calibration. One or more working electrodes may be positioned inside openable boxes from EAP, and be opened for the duration of the measurement and closed immediately after, succeeding one another in the measurement, as their sensitivity is diminished.

Abstract: An apparatus for analysing a bodily fluid sample, comprising a substrate having supported thereon: bodily fluid collecting means configured to collect a bodily fluid from the surface of a body part placed adjacent to the bodily fluid collecting means; means for analysing the collected bodily fluid sample; and means for displaying an indication of a result of the analysis.

Abstract: The invention relates to a method for the electrochemical measurement of an analyte concentration in vivo, comprising a fuel cell with which the analyte to be measured is reacted catalytically with an enzyme contained in an enzyme layer and which supplies an electrical voltage, dependent on the analyte concentration to be measured, beween an anode and a cathode, which voltage is measured. In the catalytic reaction of the analyte to be measured in the enzyme layer, a product is generated which, as fuel of the fuel cell, oxidizes on the anode and is reduced on the cathode. The invention further relates to a fuel cell for such a method.

Abstract: Method and apparatus for providing multiple data receiver units in a data monitoring and management system such as analyte monitoring system where a first data receiver includes all of the functionalities for the data monitoring and management system receiver unit, and a second data receiver unit is configured with limited functions to provide application specific convenience to the user or patient is disclosed.

Abstract: Provided herein is a stabilized oxygen transport matrix that includes a reversible oxygen binding protein, such as hemoglobin, immobilized throughout the stabilized oxygen transport matrix. The stabilized oxygen transport matrix is used to transport oxygen and can be used as an oxygen transport region and a reaction region of an analyte sensor, such as an implantable glucose sensor. The reversible binding protein can also function as an oxygen probe within the analyte sensor.

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 an electrochemical sensor incorporating a silver/silver chloride reference electrode, wherein a capacity of the reference electrode is controlled.

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 a host's peripheral vein or artery.

Abstract: A region of skin, other than the fingertips, is stimulated. After stimulation, an opening is created in the skin (e.g., by lancing the skin) to cause a flow of body fluid from the region. At least a portion of this body fluid is transported to a testing device where the concentration of analyte (e.g., glucose) in the body fluid is then determined. It is found that the stimulation of the skin provides results that are generally closer to the results of measurements from the fingertips, the traditional site for obtaining body fluid for analyte testing.

Abstract: A sensor system includes a sensor and a sensor electronics device. The sensor includes a plurality of electrodes. The sensor electronics device includes a connection detection device, a power source, and a delay circuit. The connection detection device determines if the sensor electronics device is connected to the sensor and transmits a connection signal. The delay circuit receives the connection signal, waits a preset hydration time, and couples the regulated voltage from the power source to an electrode in the sensor after the preset hydration time has elapsed. Alternatively, the sensor electronics device may include an electrical detection circuit and a microcontroller. The electrical detection circuit determines if the plurality of electrodes are hydrated and generates an interrupt if the electrodes are hydrated. A microcontroller receives the interrupt and transmits a signal representative of a voltage to an electrode of the plurality of electrodes.

Abstract: Method and apparatus for providing calibration of analyte sensor including applying a control signal, detecting a measured response to the control signal, determining a variance in the detected measured response, and estimating a sensor sensitivity based on the variance in the detected measured response is provided

Abstract: An in vivo amperometric sensor is provided for measuring the concentration of an analyte in a body fluid. The sensor comprises a counter electrode and a working electrode, and the working electrode comprises a sensing layer which is generally water permeable and arranged on a support member adjacent to a contact pad. The sensing layer comprises an immobilized enzyme capable of acting catalytically in the presence of the analyte to cause an electrical signal. The sensing layer has an upper surface facing the body fluid and a lower surface facing away from the body fluid, and the immobilized enzyme is distributed within the sensing layer in such a way that the enzyme concentration in the middle between the upper and lower surfaces is at least as high as on the upper surface of the sensing layer.

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 long term analyte sensor for measuring at least one analyte in the body of a user and which includes a housing, a plurality of analyte contacting sensor elements and at least one structure for relaying information away from the sensor. This plurality of analyte contacting sensor elements are typically disposed in an array. The analyte sensor further includes at least one sensor protection membrane that is controllable in a manner such that sensor elements may be activated (e.g. exposed to the external environment) at different times so as to extend the useful life of the sensor. In illustrative analyte sensors, the analyte is glucose.

Abstract: A tubular sensor includes a tubular body having a longitudinally extending cavity, an insulation layer formed on the inner wall surface of the tubular body; and a plurality of longitudinally extending electrodes formed on the insulation layer and extending continuously from one end to the other end of the tubular body. The tubular sensor can be employed in a constituent measuring device. The tubular sensor can be manufactured by forming the insulation layer on a thin metal sheet, forming the plurality of electrodes on the insulation layer in stripes, cutting the thin metal sheet with the insulation layer and the electrodes formed thereon to produce a plate-shaped body having a development shape of the tubular body, and press working the plate-shaped body to form the tubular body.

Abstract: The present invention provides a transdermal sensor for detecting a concentration of a hypodermal target molecule, comprising: a substrate; a plurality of microneedles fixed on said substrate; a signal processing unit, which is electrically connected to said microneedles; and a power supply unit for providing the working power. The transdermal sensor of the present invention detects long-term, real-time concentration of a hypodermal target molecule for a doctor to evaluate a physiological status of an user with minimal invasive piercing and pain.

Abstract: Disclosed herein is a device comprising a biosensor having disposed upon it a coating; the coating comprising a polymer matrix; where the polymer matrix is operative to facilitate the inwards and outwards diffusion of analytes and byproducts to and from the sensing element of the biosensor; and a sacrificial moiety; the sacrificial moiety being dispersed in the polymer matrix, where the sacrificial moiety erodes with time and increases the porosity of the polymer matrix thus offsetting decreases in analyte permeability as a result of biofouling.

Abstract: Methods and apparatuses including determining a calibration parameter associated with a detected analyte value, calibrating the analyte value based on the calibration parameter, and dynamically updating the calibration parameter are disclosed. Also provided are systems, kits, and computer program products.

Abstract: Devices and methods for determining the concentration of an analyte are provided. Embodiments of the subject devices include analyte monitoring systems that include an analyte sensor capable of providing clinically accurate analyte data without a substantial time delay after operably positioning the sensor in a patient. Embodiments of the subject methods include operably positioning an analyte sensor in a patient and obtaining clinically accurate analyte data without a substantial time delay after the positioning. Also provided are systems and kits for use in analyte monitoring.

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: Embodiments described herein relate to an analyte monitoring device having a user interface with a display and a plurality of actuators. The display is configured to render a plurality of display screens, including a home screen and an alert screen. The home screen is divided into a plurality of simultaneously displayed panels, with a first panel displays a rate of change of continuously monitored analyte levels in interstitial fluid, a second panel simultaneously displays a current analyte level and an analyte trend indicator, and a third panel displays status information of a plurality of components of the device. When an alarm condition is detected, the display renders the alert screen in place of the home screen, the alert screen displaying information corresponding to the detected alarm condition. Furthermore, the actuators are configured to affect further output of the analyte monitoring device corresponding to the detected condition.

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: Sensor devices and methods are provided for detecting the presence or concentration of an analyte in fluid. The device has a reservoir; a working electrode located within the reservoir, a catalyst covering at least part of the working electrode; an oxygen-generating auxiliary electrode in the reservoir; and a reservoir cap to isolate the working and auxiliary electrodes within the reservoir. The device further includes means for selectively rupturing the cap to permit analyte from outside the reservoir to contact the catalyst. The methods may include in vivo glucose monitoring and may include implanting the device in a patient; disintegrating a reservoir cap to permit glucose to enter the reservoir; generating oxygen using the oxygen-generating auxiliary electrode; and using a working electrode to oxidize hydrogen peroxide produced by the reaction of the oxygen with glucose in the presence of glucose oxidase, and thereby detecting endogenous glucose in the patient.

Abstract: Sensors based on single-walled carbon nanotubes (SWNT) are integrated into a microfluidic system outfitted with data processing and wireless transmission capability. The sensors combine the sensitivity, specificity, and miniature size of SWNT-based nanosensors with the flexible fluid handling power of microfluidic “lab on a chip” analytical systems. Methods of integrating the SWNT-based sensor into a microfluidic system are compatible with the delicate nature of the SWNT sensor elements. The sensor devices are capable of continuously and autonomously monitoring and analyzing liquid samples in remote locations, and are applicable to real time water quality monitoring and monitoring of fluids in living systems and environments. The sensor devices and fabrication methods of the invention constitute a platform technology, because the devices can be designed to specifically detect a large number of distinct chemical agents based on the functionalization of the SWNT.

Abstract: Method and system for providing continuous calibration of analyte sensors includes calibrating a first sensor, receiving data associated with detected analyte levels from the first sensor, and calibrating a second sensor based on a predetermined scaling factor and data associated with detected analyte levels from the first sensor, is disclosed.

Abstract: The present invention provides a sensor head for use in an implantable device that measures the concentration of an analyte in a biological fluid which includes: a non-conductive body; a working electrode, a reference electrode and a counter electrode, wherein the electrodes pass through the non-conductive body forming an electrochemically reactive surface at one location on the body and forming an electronic connection at another location on the body, further wherein the electrochemically reactive surface of the counter electrode is greater than the surface area of the working electrode; and a multi-region membrane affixed to the nonconductive body and covering the working electrode, reference electrode and counter electrode. In addition, the present invention provides an implantable device including at least one of the sensor heads of the invention and methods of monitoring glucose levels in a host utilizing the implantable device of the invention.

Abstract: An analyte test device is constructed as an integrated, single-use, disposable cartridge which can be releasably installed into a compatible analyte test monitor. In use, the device can be used in conjunction with the monitor to lance the skin of a patient to create a blood sample and, in turn, calculate the concentration of a particular analyte in the expressed blood sample. In one embodiment, the device includes a base and a cover which are affixed together to create a test cartridge which has a substantially flat and low profile design. A lancet carrier is disposed between the base and the cover and includes a anchor fixedly mounted on the base and a lancet support member which is slidably mounted on the base, the anchor and the lancet support member being connected by a spring. A lancet is removably mounted on the lancet support member is disposed directly beneath an analyte test strip which secured to the underside of the cover.

Abstract: Disclosed are field effect transistor-based (FET-based) sensors for the rapid and accurate detection of analytes both in vivo and in vitro. The FET-based sensors can include a substrate, a channel disposed on the substrate, a source electrode and a drain electrode electrically connected to the channel, and a recognition element for an analyte of interest immobilized on the surface of the channel via a linking group. The distance between the recognition element and the channel can be configured such that association of the analyte of interest with the recognition element induces a change in the electrical properties of the channel. In this way, an analyte of interest can be detected by measuring a change in an electrical property of the channel. Also provided are devices, including probes and multi-well plates, incorporating the FET-based sensors.

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 tissue-implantable sensor for measurement of solutes in fluids and gases, such as oxygen and glucose, is provided. The sensor includes: i) a detector array including at least one detector; ii) a telemetry transmission portal; iii) an electrical power source; and iv) circuitry electrically connected to the detector array including signal processing means for determining an analyte level, such as glucose level, in a body fluid contacting the detectors. The sensor components are disposed in a hermetically sealed housing having a size and shape suitable for comfortable, safe, and unobtrusive subcutaneous implantation allowing for in vivo detection and long term monitoring of tissue glucose concentrations by wireless telemetry.

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: A handheld diabetes management device having a database management system is disclosed. The device comprises a plurality of input modules, including a blood glucose reader, a user interface, a communications interface, and a continuous blood glucose input module. The input modules output data used to generate data records of different record types. The device further comprises N databases, each database having a different frequency range associated thereto, wherein the new record is stored in a particular database of the N databases based on the frequency range of the particular database and the frequency of the particular record type, and N is an integer greater than 1. The device further includes a database operation module that performs database operations on the N databases. The database management system provides increased reliability in the keeping of records on which medically important decisions are made.

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: Embodiments herein provide an analyte sensor subassembly that provides an integrated structure enabling suitably secure electrical contact between an analyte sensor and the electronic components of an analyte sensor assembly. An analyte sensor subassembly assists the process of inserting the sensor into skin. An analyte sensor subassembly may operate in concert with one or more sensor insertion tools to provide insertion of an analyte sensor into the skin of a subject/patient. Associated devices, such as channel guides and sensor insertion tools, are also provided, as are methods of operation and sensor insertion.

Abstract: Disclosed herein are systems and methods for a continuous analyte sensor, such as a continuous glucose sensor. One such system utilizes first and second working electrodes to measure analyte or non-analyte related signal, both of which electrode include an interference domain.

Abstract: The present invention is broadly concerned with the crafting and manufacturability of an implantable enzymatic-based sensor characterized by a small size, optimum geometry, linearity of response over the concentration range of interest, extended shelf-life, selectivity for the analyte in question, and the ability to exclude bioactive interferents. More particularly, it is preferably concerned with a general approach to optimize the performance of the biorecognition elements required to produce biosensors of the type designed to provide, and in conjunction with a suitable signal processing unit, a current which is proportional to the concentration of the analyte of interest. The biosensors described herein may be implanted in vivo, including intra-cerebral, sub-cutaneous, intra-muscular, inter-peritoneal oral, serum, and vascular implantation, the majority of which may act as a surrogate for systemic monitoring and used to monitor analytes of interest in real-time.

Abstract: Methods and systems to collect a sample of bodily fluid from a patient using an integrated needle and test strip assembly are provided. In this novel assembly, the test strip and needle form one unit that captures the sample of blood or interstitial fluid from the patient once the apparatus is pressed to the skin. The hollow aspiration needle includes more than one opening at a distal end, each opening coming into contact with the bodily fluid when disposed within a cutaneous or subcutaneous layer of the patient's skin. The disclosed test strip includes at least one reaction site for testing analyte concentrations and a means for linking to many commercially available test strip meters to provide readout of the analyte concentration. The sample may be captured by capillary flow, by an integrated aspirator, or by a differential vacuum device resident on the test strip meter.

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: 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: 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.