Abstract: A method for wireless transmission of data between a master controller (2, 2?) having a receiver (10) and a transmitter (9), and at least one slave device (3) having a receiver (19) and a transmitter (18), and to a corresponding blood glucose system (1, 1?). The slave device (3) is normally operated in a power saving mode in which its receiver (19) is only activated intermittently at a receiver activation frequency for a predetermined listening period. The controller (2, 21) transmits a communication initiation data frame to the slave device (3) by means of a signal comprising a preamble signal transmitted for a preamble period. Upon receipt of the communication initiation data frame, the slave device (3) is switched to a communication mode in which it transmits a response to the controller (2, 21), and the slave device (3) is switched from the communication mode to the power saving mode.

Abstract: Disclosed herein are methods of estimating an analyte concentration which include generating a signal indicative of the analyte concentration, generating a signal indicative of a temperature, generating a signal indicative of a pH, and transforming the signal indicative of the analyte concentration utilizing an equation of the form of a modified Michaelis-Menten equation depending on Michaelis-Menten parameters, wherein values of the Michaelis-Menten parameters are set based upon data which includes temperature and pH calibration parameters, the signal indicative of a temperature, and the signal indicative of a pH. Also disclosed herein are measurement devices which employ the aforementioned methods.

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: In aspects of the present disclosure, an auto turn on blood glucose monitoring unit including a calibration unit integrated with one or more components of an analyte monitoring system is provided. Also disclosed are methods, systems, devices and kits for providing the same.

Abstract: Systems and methods for processing sensor data are provided. In some embodiments, systems and methods are provided for calibration of a continuous analyte sensor. In some embodiments, systems and methods are provided for classification of a level of noise on a sensor signal. In some embodiments, systems and methods are provided for determining a rate of change for analyte concentration based on a continuous sensor signal. In some embodiments, systems and methods for alerting or alarming a patient based on prediction of glucose concentration are provided.

Abstract: The present invention relates to a device for sensing a target chemical. The device includes a flexible, non-planar substrate; a printed, solid-state sensing element comprising a chemical sensing material which produces an electrical signal upon interaction with the target chemical; a first printed electrode comprising a first conductive composition; and a second electrode comprising a second conductive composition. The first and second electrodes are electrically isolated from one another, and one or both of the first and second electrodes is in electrical contact with said sensing element. The first and second electrodes and the sensing element collectively form an electrochemical sensor which is coupled to the flexible, non-planar substrate. Medical devices comprising the device of the present invention and methods of making a device for sensing a target chemical are also disclosed.

Abstract: An implantable medical lead having a modified electrode surface for imparting current density directionality within an electrode is disclosed. An implantable medical lead includes a lead body having a proximal section and a distal section having a pre-biased shape configured to secure the lead to an inner wall of a blood vessel. An electrode coupled to the distal section of the lead body includes a number of surface features on an inactive portion of the electrode that impart a current density directionality towards an active portion of the electrode that contacts the inner wall of the vessel. Methods for imparting current density directionality within an implantable lead electrode are also disclosed.

Abstract: Techniques and systems are disclosed for implementing textile-based screen-printed amperometric or potentiometric sensors. The chemical sensor can include carbon based electrodes to detect at least one of NADH, hydrogen peroxide, potassium ferrocyanide, TNT or DNT, in liquid or vapor phase. In one application, underwater presence of chemicals such as heavy metals and explosives is detected using the textile-based sensors.

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

Abstract: A method for sterilizing an implantable sensor for sensing an analyte in a body tissue. The implantable sensor has a sensor part which can be introduced into the body tissue, at least one sensor electrode for sensing the analyte, and at least one electronics part. The electronics part has at least one electronic component and is connected to the sensor part. The method includes (a) introducing the implantable sensor into a package, the package sealing the implantable sensor from bacteria and accommodating a radiation shield, (b) irradiating the implantable sensor in the package with sterilizing radiation from at least one irradiating direction, in particular with electron radiation, the radiation shield shielding the electronic component of the electronics part from the sterilizing radiation, the radiation shield being arranged in such a way that the sensor part is sterilized by the sterilizing radiation.

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: 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 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: Transdermal sampling and analysis device, method and system are provided for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples. The transdermal sampling and analysis device, method and system may cause disruption to the skin cells to create capillary-like channels from which biological samples may flow to the transdermal sampling and analysis device. The transdermal sampling and analysis device, method and system may collect the biological samples in a reservoir and transport the biological samples to a sensing chamber. The sensing chamber may contain at least two sensing electrodes coated with a biologically reactive element which reacts with the transported biological sample. The sensing chamber may be configured to mitigate the formation of air bubbles which may impede the transport and distribution of the biological sample across the entirety of the sensing chamber.

Abstract: A medical device is provided which may include a reservoir which has an opening and contains a sensor; a reservoir cap closing off the opening to isolate the sensor from an environmental component outside the reservoirs, the reservoir cap being impermeable to the environmental component and adapted to selectively undergo a phase change to disintegrate the reservoir cap and thereby expose the sensor to the environmental component. A method of use may include (i) selectively disintegrating a reservoir cap to expose a sensor which is disposed inside a reservoir of a device implanted in a patient, the disintegrating comprising inducing a phase change in the reservoir cap; and (ii) using the sensor to generate an output signal, wherein the output signal is recorded and stored in a writeable computer memory chips, directed to a microprocessor for immediate analysis and processing, or sent to a remote location away from the device.

Abstract: Systems and methods for processing sensor analyte data, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. During initial calibration, the analyte sensor data is evaluated over a period of time to determine stability of the sensor. The sensor may be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. The calibration may be updated after evaluating the calibration set for best calibration based on inclusion criteria with newly received reference analyte data. Fail-safe mechanisms are provided based on clinical acceptability of reference and analyte data and quality of sensor calibration. Algorithms provide for optimized prospective and retrospective analysis of estimated blood analyte data from an analyte sensor.

Abstract: The present invention relates to a method for fabricating a hollow microneedle having a variable appearance. The method makes it possible to vary the length of the microneedle, the outer and inner diameters of the upper and lower parts thereof, the aspect ratio, the sharpness, and the structural bending rate thereof, in accordance with the purposes of the same. Accordingly, the appearance of the hollow microneedles according to the present invention can be varied with flexibility according to various purposes, such as the transferring of medication and the taking of a blood sample, and to various factors, such as the target part for the medication transfer, the depth of the medication transfer, and the amount and viscosity of the medication. Thus, the microneedle can be used as a multi-purpose device for transferring medication.

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 blood inspection device capable of separately discharging a sensor and a filter by using a single discharger means. The blood inspection device has a housing provided with a circular hollow cylindrical body having an opening. A filter including a filter is provided inside the cylindrical body, and a sensor is provided outside the cylindrical body. A body of the discharger is slidable outside the cylindrical body. A first discharge section of the discharge comes into contact with the sensor unit to push out and discharge it. A second discharge section of the discharger comes into contact with the filter to push out and discharge it.

Abstract: The present disclosure provides electrode structures and integrated electrode structures having one or more conductive materials coextruded with one or more dielectric materials. The disclosed electrode structures can be configured for use as analyte sensors. Also provided, are methods of making and using the electrode structures and integrated electrode structures described herein.

Abstract: Novel membranes comprising various polymers containing heterocyclic nitrogen groups are described. These membranes are usefully employed in electrochemical sensors, such as amperometric biosensors. More particularly, these membranes effectively regulate a flux of analyte to a measurement electrode in an electrochemical sensor, thereby improving the functioning of the electrochemical sensor over a significant range of analyte concentrations. Electrochemical sensors equipped with such membranes are also described.

Abstract: The disclosure describes systems, methods, and apparatus providing detection mechanism for lead-related conditions, including transient behaviors, on a conductive pathway of a medical electrical lead. In one example, a sense path arbitration module identifies a lead-related condition associated with a conductive pathway based on signal processing to identify transients emerging from a propagated signal. The sense path arbitration module may evaluate a plurality of conductive pathways of the medical electrical lead and arbitrates propagation of a sensed signal that is transmitted through the plurality of lead conductors based on the evaluation. Therapy delivery functions utilizing the medical electrical lead may also be controlled in response to the signal processing and identification of the lead-related condition on a conductive pathway.

Abstract: An analyte measuring system has an implantable medical device having a signal source arranged for generating a current signal and electrodes for applying the current signal to a surrounding tissue in a subject body. The device measures a resulting voltage signal with the electrodes and calculates an impedance signal therefrom. The system comprises a signal processor arranged for generating an estimate of a concentration of an analyte in the tissue based on a spectrum analysis of the determined impedance signal.

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: Systems and methods for processing sensor analyte data, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. During initial calibration, the analyte sensor data is evaluated over a period of time to determine stability of the sensor. The sensor may be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. The calibration may be updated after evaluating the calibration set for best calibration based on inclusion criteria with newly received reference analyte data. Fail-safe mechanisms are provided based on clinical acceptability of reference and analyte data and quality of sensor calibration. Algorithms provide for optimized prospective and retrospective analysis of estimated blood analyte data from an analyte sensor.

Abstract: A method for determining impedance includes receiving a time varying voltage signal from a biosensor and receiving a time varying current signal from the biosensor. The time varying voltage signal and the time varying current signal are transformed to a domain that represents complex values. The impedance representative of the biosensor based upon the transformed time varying voltage signal and the time varying current signal is calculated.

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: The present invention relates to an analyzing instrument (X1) provided with a capillary (5) for moving a sample liquid. The analyzing instrument (X1) includes a dehumidification region for maintaining a constant moisture content in the capillary (5). Preferably, the dehumidification region has a hygroscopicity of no less than 2%. Preferably, at least part of an inner surface of the capillary (5) extends in the moving direction of the sample liquid and is a water-insoluble high-wettability region having a wettability of no less than 57 mN/m. The dehumidification region and the high-wettability region may be made of Vinylon, for example. Preferably, the analyzing instrument (X1) includes a liquid pooling portion (4) communicating with the capillary (5) and having a portion wider than the capillary (5).

Abstract: A system for continuous in vivo biosensing of specific analyte molecule concentrations based on the dynamic optical properties of electronic polymers is disclosed. The biosensor system includes at least one implant member subcutaneously exposed to the interstitial fluid of the subject, and a reader member at least temporarily positioned over the implant member to probe it with light of specific wavelengths through the skin. The system has many potential applications, including the real-time monitoring of blood glucose levels in diabetics as a method to supplement or replace conventional capillary blood testing.

Abstract: Systems and methods for processing sensor data are provided. In some embodiments, systems and methods are provided for calibration of a continuous analyte sensor. In some embodiments, systems and methods are provided for classification of a level of noise on a sensor signal. In some embodiments, systems and methods are provided for determining a rate of change for analyte concentration based on a continuous sensor signal. In some embodiments, systems and methods for alerting or alarming a patient based on prediction of glucose concentration are provided.

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 additional analyte or non-analyte related signal. Such measurements may provide a background and/or sensitivity measurement(s) for use in processing sensor data and may be used to trigger events such as digital filtering of data or suspending display of data.

Abstract: Systems and methods for processing sensor data are provided. In some embodiments, systems and methods are provided for calibration of a continuous analyte sensor. In some embodiments, systems and methods are provided for classification of a level of noise on a sensor signal. In some embodiments, systems and methods are provided for determining a rate of change for analyte concentration based on a continuous sensor signal. In some embodiments, systems and methods for alerting or alarming a patient based on prediction of glucose concentration are provided.

Abstract: Disclosed are methods and apparatuses for determining analyte concentration in a sample such as bodily fluid. Systems and methods disclosed herein can also include a treatment dosing system to infuse or inject a treatment dose (e.g. insulin, dextrose, etc.) and provide glycemic control. The dose of the treatment drug may be based on the patient's calculated sensitivity to treatment dosing, for example. The dose of the treatment drug may be based on the concentration of the analyte or the average value for the concentration of the analyte and/or the rate of change of the value of the concentration of the analyte. Delivery of the treatment drug can be cut off if the determined analyte concentration indicates that continued delivery would be harmful to the patient.

Abstract: The present invention relates to an arterial flashback confirmation chamber. Generally, the confirmation chamber is used with a vascular access device to allow an operator to see active arterial flashback confirmation for a period of time that is long enough to permit the operator to properly place the cannula of the vascular access device within a patient's artery. In some instances, the confirmation chamber comprises a flashback compartment, means for prolonging active arterial flashback confirmation, and a vent. Some examples of suitable prolonging means comprise a flashback compartment with a relatively large internal volume, circuitous tubing, an absorbent material, an orifice and/or tubing with a smaller inner diameter than the inner diameter of the cannula, and the like. Where the vascular access device comprises a catheter assembly, the catheter assembly and confirmation camber are optionally used with a guide wire and/or a blood sensor.

Abstract: The present invention relates to an active transdermal analyte detection system performing extraction and detection of body analytes comprising of a patch accepting at least one electrical input; a plurality of transducers configured for converting input electrical energy to different forms of energies for activating extraction procedure; a controller configured for providing the control signals, intensity, sequence, nature, and timing information for the different energies supplied to the said patch vide said transducers; and at least one layer/compartment configured for either collection of extracted fluids and/or delivering at least one reagent formulation that detects the body analyte on activation and a method for performing transdermal extraction and detection of body fluids using said electronic patch.

Abstract: Systems and methods for non-vascular sensor implantation and for measuring physiological parameters in areas of a body where the physiological parameters are heterogeneous. An implant unit is implanted in an area of a body and a foreign body capsule is allowed to form around the implant unit area. A sensor may be directed into a body cavity such as, for example, the peritoneal space, subcutaneous tissues, the foreign body capsule, or other area. A subcutaneous area of the body may be tunneled for sensor placement. Spatially separated sensing elements may be used for detecting individual amounts of the physiological parameter. An overall amount of the physiological parameter may be determined by calculating a statistical measurement of the individual sensed amounts in the area. Another embodiment of the invention, a multi-analyte measuring device, may include a substrate having an electrode array on one side and an integrated circuit on another side.

Abstract: Systems and methods for processing sensor analyte data, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. During initial calibration, the analyte sensor data is evaluated over a period of time to determine stability of the sensor. The sensor may be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. The calibration may be updated after evaluating the calibration set for best calibration based on inclusion criteria with newly received reference analyte data. Fail-safe mechanisms are provided based on clinical acceptability of reference and analyte data and quality of sensor calibration. Algorithms provide for optimized prospective and retrospective analysis of estimated blood analyte data from an 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 a vascular access device, a sensor and sensor electronics, the system being configured for insertion into communication with a host's circulatory system.

Abstract: Aspects of the present disclosure include methods for determining the presence and/or concentration of an analyte. In practicing methods according to certain embodiments, an analyte sensing unit is positioned at a location on the abdomen of a that experiences involuntary movement sufficient to provide for mixing of non-circulating interstitial fluid with circulating interstitial fluid and determining an analyte concentration in the interstitial fluid. Also provided are methods for positioning an analyte sensing unit at a location on the abdomen of a subject, and methods of determining an analyte concentration while the subject is asleep, e.g., during a rapid eye movement (REM) sleep period. Devices and systems for practicing the subject methods also described.

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 application provides Ag/AgCl based reference electrodes having an extended lifetime that are suitable for use in long term amperometric sensors. Electrochemical sensors equipped with reference electrodes described herein demonstrate considerable stability and extended lifetime in a variety of conditions.

Abstract: Devices and methods are described for providing continuous measurement of an analyte concentration. In some embodiments, the devices include a membrane that has an interference domain designed to reduce the permeation of one or more interferents.

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: Novel membranes comprising various polymers containing heterocyclic nitrogen groups are described. These membranes are usefully employed in electrochemical sensors, such as amperometric biosensors. More particularly, these membranes effectively regulate a flux of analyte to a measurement electrode in an electrochemical sensor, thereby improving the functioning of the electrochemical sensor over a significant range of analyte concentrations. Electrochemical sensors equipped with such membranes are also described.

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: Novel membranes comprising various polymers containing heterocyclic nitrogen groups are described. These membranes are usefully employed in electrochemical sensors, such as amperometric biosensors. More particularly, these membranes effectively regulate a flux of analyte to a measurement electrode in an electrochemical sensor, thereby improving the functioning of the electrochemical sensor over a significant range of analyte concentrations. Electrochemical sensors equipped with such membranes are also described.

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: 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: In particular embodiments, methods, devices and systems including calibrating analyte data associated with a monitored analyte level received from an analyte sensor based on a reference measurement, determining a lag time constant associated with the calibrated analyte data, and performing lag correction of the calibrated analyte data based on the determined time lag constant are disclosed.