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 where the biological sample may chemically react with a biologically reactive element. A sensor may convert the produced electrons (ions) into measured electrical signals. The converted signals may be measured and the levels of an analyte may be determined based on the measured signals.

Abstract: A device for measuring the glucose level in living tissue has electrodes (5, 6) for being brought into contact with the specimen and a voltage-controlled oscillator (31) as a signal source for generating an AC voltage in a given frequency range. The AC voltage is applied to the electrodes (5, 6). A voltage over the electrodes is fed to a processing circuitry (37, 38), which converts it to the glucose level using calibration data. The voltage-controlled oscillator (31) has a symmetric design with adjustable gain for generating signals in a large frequency range with low distortions at a low supply voltage. The processing circuit comprises a simple rectifier network with software-based correction. The electrodes (5, 6) are of asymmetric design and optimized for biological compatibility.

Abstract: A device for measuring a glucose level or some other parameter of living tissue that affects the dielectric properties of the tissue is disclosed. The device comprises an electrode arrangement (5) having a plurality of electrodes (5-i). The signal from a signal source (31) can be applied to the electrode arrangement via a switching assembly (39). The switching assembly (39) is designed to selectively connect a first and a second pattern of the electrodes (5-i) to the signal source, thereby generating a first and a second electrical field with different spatial distribution in the tissue. By using a differential method which relies on measuring the impedance of the electrode arrangement (5) for each field and on suitable subtraction of the measured results, surface effects can be reduced and the focus of the measurement can be offset to a point deeper inside the tissue.

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 system for monitoring strain as an indicator of biological conditions, such as spinal fusion, glucose levels, spinal loading, and heart rate. The system includes an inter-digitated capacitor sensor, and RF transmitter, and an associated antenna, all of which are microminiature or microscopic in size and can be implanted in a biological host such as a human or animal. An inductively coupled power supply is also employed to avoid the need for implantation of chemical batteries. Power is provided to the sensor and transmitter, and data is transmitted from the sensor, when an external receiving device, such as a handheld RF ID type receiver, is placed proximate the location of the implanted sensor, transmitter and inductively coupled power supply. The implanted sensor, transmitter and inductively coupled power supply can be left in place permanently or removed when desired.

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 electrochemical sensor includes a base plate including one end portion and another end portion, an electrode portion formed on the one end portion of the base plate, a connecting portion, formed on the another end portion of the base plate, for electrically connecting the electrode portion to a monitoring instrument, and an attaching portion formed on the another end portion, the attached portion being employed for attaching the another end portion to the monitoring instrument in a state where the one end portion is enabled to swing relatively to the monitoring instrument.

Abstract: An apparatus and method for measuring the blood glucose level of a diabetic using insulin is noninvasive. The apparatus includes two plethysmographs that sense the blood in two fingers simultaneously. The electrodes in the plethysmographs are immersed in conductive liquids. One liquid has electric conductivity equal to blood. The other liquid is more conductive than blood. Signals from the fingers are compared to signals obtained earlier when glucose levels were known from conventional measurements. An alternative embodiment employs a single plethysmograph with one set of electrodes in a surrounding chamber and a second set of electrodes against the skin surface.

Abstract: Analyte monitoring systems and methods that make interstitial fluid from a patient's body available to one or more sensors disposed outside the patient's body. The monitoring systems and methods may be used in conjunction with medicament dispensing systems and methods in order to provide a feedback loop for continuous sensing of analyte levels and corresponding dispensing of medicament based on sensed analyte levels. Dispensing or pumping systems or portions thereof may be used to move a patient's interstitial fluid into communication with the one or more 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: A method of calibrating an analyte measurement system is provided.

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: 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 a limited functions to provide application specific convenience to the user or patient is disclosed.

Abstract: Embodiments of the invention disclosed herein comprise amperometric glucose sensor systems that include multiple working electrodes having different material properties as well as algorithms and other elements designed for use with such systems. While embodiments of the innovation can be used in a number of contexts, typical embodiments of the invention include glucose sensors used to facilitate the management of diabetes.

Abstract: A method and device for determining the glucose level in living tissue are based on measuring the response of the tissue an electric field as well as temperature measurements. In order to improve accuracy, it has been found that measurements in at least three frequency ranges between 1 kHz and 200 kHz, 0.2 MHz an 100 MHz as well as above 1 GHz should be combined since the response of the tissue in these different frequency ranges is ruled by differing mechanisms.

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: An analyte sensor for use in connection with a biofluid is described. The analyte sensor may comprise any suitable interface between the biofluid and a derivative of the biofluid and any suitable transducer of information concerning an analyte. At least one catalytic agent is provided in a locale or vicinity of the interface. The catalytic agent, such as a proteinaceous agent or a non-proteinaceous, organic-metal agent, is sufficient to catalyze the degradation of reactive oxygen and/or nitrogen species that may be present in the vicinity of the interface. An analyte-sensing kit and a method of sensing an analyte are also described.

Abstract: A device is described for measuring a parameter of living tissue, in particular a glucose level, which parameter affects a response of said tissue to an electric field. The device comprises a substrate (2), which carries a ground electrode (10) as well as a plurality of signal electrodes (12a, 12b, 13a-13c, 14). The gaps (15) between the ground electrode and the signal electrodes are filled with a solid filler material (16) in order to provide an even surface. Optical reflection detectors (23a, 23b, 23c) can also be located in these gaps in order to avoid field distortions and obtain a compact design. The backside of substrate (2) carries electronic high-frequency components for improving signal quality.

Abstract: A sensor is described for optically determining the concentration of an analyte in a body fluid. This sensor comprises a needle arrangement which has at least one hollow needle having a hollow space extending from the distal end to the proximal end, the distal end of which is suitable for lancing. The proximal end of the needle opens into a chamber in which liquid that enters through the distal end of the needle can be collected. A window which is at least partially permeable to infrared radiation is in direct contact with the chamber.

Abstract: An analyte sensor including an antiglycolytic agent or a precursor thereof and a chelating agent that stabilizes the antiglycolytic agent positioned proximate to the working electrode of the sensor. Also provided are systems and methods of using the electrochemical analyte sensors in analyte monitoring.

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

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: Methods and apparatus for analyte level estimation are provided.

Abstract: Methods of estimating the temperature of a reaction site on a measurement strip in a blood glucose measuring devices are provided. In one embodiment, a method includes determining an activation initiation time, an activation duration time, a thermal magnitude and a temperature elevation for heat generating components within a device. The temperature elevation for each of the heat generating components is determined at least in part by an impulse response matrix [Xi], the activation initiation time, the activation duration time and the thermal magnitude for each of the heat generating components.

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

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 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: Disclosed herein is an analyte sensing biointerface that comprises a sensing electrode incorporated within a non-conductive matrix comprising a plurality of passageways extending through the matrix to the sensing electrode. Also disclosed herein are methods of manufacturing a sensing biointerface and methods of detecting an analyte within tissue of a host using an analyte sensing biointerface.

Abstract: Embodiments of the invention provide a dual insertion set for supplying a fluid to the body of a patient and for monitoring a body characteristic of the patient. Typical embodiments of the invention include a base, an infusion portion coupled to a first piercing member and a sensor portion coupled to a second piercing member. The infusion portion includes a cannula coupled to the piercing member for supplying a fluid to a placement site. The sensor portion includes a sensor coupled to and extending from the base having at least one sensor electrode formed on a substrate and is coupled to the piercing member in a manner that allows the sensor to be inserted at the placement site. The base is arranged to secure the dual insertion set to the skin of a patient.

Abstract: The present invention includes a method and device for warning of hypoglycaemic attacks, which is a big problem for especially diabetics, who are in insulin treatment. It is estimated that about 1 million people have a decreased quality of life as a result of hypoglycaemic attacks. The invention collects EEG signals from people, who must be supervised and analyses these in order to detect characteristic changes in the EEG signals, which occurs in advance of a hypoglycaemic attack. In a preferred embodiment the EEG signals are collected with subcutaneously placed electrodes and the signals are lead via wires drawn under the person's skin to a similar subcutaneously placed signal processing unit. The signal processing analyses the EEG signals and when the pre-seizure characteristics signal changes are detected, a warning signal is given to the person from an alarm giver build into the signal processing unit, e.g. in form of a vibrator.

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: A glucose monitoring system, includes a glucose sensor strip or package of strips. The strip includes a substrate and a glucose monitoring circuit that has electrodes and a bodily fluid application portion of selected chemical composition. An antenna is integrated with the glucose sensor strip. A RFID sensor chip is coupled with the glucose sensor strip and the antenna. The chip has a memory containing digitally-encoded data representing calibration and/or expiration date information for the strip.

Abstract: Electrochemical systems for measuring an analyte concentration, and correcting any surplus or deficiency in the measured concentration. More specifically, systems for measuring an analyte level in a fluid with an implantable sensor, processing the measurements with an algorithm, and determining an appropriate fluid infusion rate in response to the measurements.

Abstract: According to an embodiment of the invention, a method of determining hydration of a sensor having a plurality of electrodes is disclosed. In particular embodiments, the method couples a sensor electronics device to the sensor and measures the open circuit potential between at least two of the plurality of electrodes. Then, the open circuit potential measurement is compared to a predetermined value. In some embodiments, the plurality of electrodes includes a working electrode, a reference electrode, and a counter electrode. In still further embodiments, the open circuit potential between the working electrode and the reference electrode is measured. In other embodiments, the open circuit potential between the working electrode and the counter electrode is measured. In still other embodiments, the open circuit potential between the counter electrode and the reference electrode is measured.

Abstract: A method and system that enables a user to maintain a sensor in real time. The present invention involves performing a diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure to measure sensor impedance value in order to determine if the sensor is operating at an optimal level. If the sensor is not operating at an optimal level, the present invention may further involve performing a sensor remedial action. The sensor remedial action involves reversing the DC voltage being applied between the working electrode and the reference electrode. The reversed DC voltage may be coupled with an AC voltage to extend its reach.

Abstract: Method and apparatus for charging a power supply unit such as a rechargeable battery for use in data monitoring and management system using the ESD protection circuitry of the existing electrode contacts including guard contact and counter electrode thereby reducing system cost, complexity, and any unprotected battery contacts exposed for potential contamination is provided.

Abstract: A blood monitoring system is capable of monitoring the blood of a subject in vivo. The blood monitoring system comprises: 1) an array of movable microneedle micromachined within associated wells; 2) array of motion actuators able to move each needle in and out of their associated wells; 3) array of microvalves associated with each microneedle able to control the flow of air around the microneedle; 4) an array of chemical sensors inserted into patient by movable microneedles; 5) an array of inductors able to measure chemical concentration in the vicinity of inserted chemical sensors; 6) conducting vias that provide timed actuating signal signals from a control system to each motion actuator; 7) conducting vias that transmit signal produced by array of chemical sensors to the control system for processing, although the blood monitoring system can comprise other numbers and types of elements in other configurations.

Abstract: A glucose monitoring system, includes a glucose sensor strip or package of strips. The strip includes a substrate and a glucose monitoring circuit that has electrodes and a bodily fluid application portion of selected chemical composition. An antenna is integrated with the glucose sensor strip. A RFID sensor chip is coupled with the glucose sensor strip and the antenna. The chip has a memory containing digitally-encoded data representing calibration and/or expiration date information for the strip.

Abstract: A blood sensor includes a base (12), a detection part (16) disposed on the base (12), a blood collection needle (13) disposed at a front end (12a) of the base (12), a negative pressure generation part (17) for applying negative pressure to a portion of the blood collection needle (13), and a supply path (15) for supplying blood collected by the blood collection needle (13) to a detection part (16).

Abstract: Methods and devices to detect analyte in body fluid are provided. Embodiments include receiving one or more analyte sensor data, receiving a reference measurement value associated with an analyte level, determining a sensitivity parameter based on the received one or more analyte sensor data and the reference measurement value, performing a probability analysis based on prior analyte sensor data to determine presence of signal attenuation, and generating an output value based on the probability analysis.

Abstract: Medical devices, utilizing multiple reservoirs to protect and selectively expose sensors or other reservoir contents, are provided having (i) a reservoir contents destruction mechanism to interrupt the release or exposure of reservoir contents, for example, to deactivate an unneeded sensor and prevent it from negatively impacting other sensors, (ii) a protective covering material layer over the sensor underneath the reservoir cap, which protects the sensor membrane and sensor during reservoir cap disintegration and then is removed, (iii) a device design for containing sensors in shallow, wide reservoir structures to enhance sensor exposure by minimizing molecular diffusion distances, (iv) an implantable sensor unit and a separate drug delivery unit, or (v) combinations thereof.

Abstract: The methods and apparatus for detecting an analyte in blood are useful for detecting an analyte in tissue of a subject. The apparatus comprises a sensor, which comprises an elongated conductive material having a protrudent end, the protrudent end comprising an electrode that detects the presence of an analyte; a substrate affixed to the conductive material; and a support having an external surface, a proximal end, and a distal end. The conductive material is positioned on the support and the protrudent end of the conductive material protrudes beyond the distal end of the support. Optionally, the sensor is suspended within the lumen of a venous flow device. Typically, only a portion of the sensor is suspended within the lumen of the venous flow device, said portion comprising the protrudent end of the conductive material. Alternatively, the conductive material is positioned on the external surface of the intravenous infusion catheter.

Abstract: A plug capable of providing information relating to a physical or chemical property of a body fluid, or the presence or amount of a molecular component therein in a living organism is disclosed. Specifically, one embodiment plug is capable of being inserted into a portion of a human eyelid in order to provide information relating to tear fluid is disclosed. This embodiment plug includes a body having a passage which allows for the natural flow of tear fluid therethrough. In addition, a sensing mechanism is provided which is capable of measuring, for example, glucose levels in the body of a patient through the analysis of the tear fluid. Such plug may further be designed so as to double as a punctual plug useful in preventing dry eye. Methods of utilizing and implanting such plugs are also disclosed.

Abstract: Embodiments of the invention provide amperometric analyte sensors having multiple related structural elements (e.g. sensor arrays comprising a working, counter and reference electrode) and algorithms designed for use with such 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: A method of measuring an analyte concentration in body fluid. The method includes the use of an analyte measuring device that has an analyte sensing element with a sharpened distal end and further has an indicating electrode covered by an absorbent layer. Also, an electric power, data processing and display device is adapted to mate to and activate the analyte sensing element by applying electric power to it and adapted to receive the raw analyte measurement and to compute and display a refined analyte measurement from the raw analyte measurement. The analyte sensing element is introduced into the animal body, thereby placing the absorbent layer into contact with the body fluid. The absorbent layer becomes saturated with body fluid and the analyte sensing element is removed from the body and is activated to form a raw analyte measurement. Which which is used to form and display a refined analyte measurement.

Abstract: The present invention relates generally to systems and methods for improved electrochemical measurement of analytes. The preferred embodiments employ electrode systems including an analyte-measuring electrode for measuring the analyte or the product of an enzyme reaction with the analyte and an auxiliary electrode configured to generate oxygen and/or reduce electrochemical interferants. Oxygen generation by the auxiliary electrode advantageously improves oxygen availability to the enzyme and/or counter electrode; thereby enabling the electrochemical sensors of the preferred embodiments to function even during ischemic conditions. Interferant modification by the auxiliary electrode advantageously renders them substantially non-reactive at the analyte-measuring electrode, thereby reducing or eliminating inaccuracies in the analyte signal due to electrochemical interferants.