Abstract: A sensor unit for use in measurements on a subject is presented. The sensor unit includes a near field electromagnetic sensor and a flexible signal transmission structure, which are integral with one another by means of at least one common continuous surface. The flexible signal transmission structure is constructed from a first layer including signal connection lines associated with sensor cells near field electromagnetic sensor and a second electrically conductive layer electrically coupled to the electrically conductive material of the sensor.

Abstract: An analyte monitor including a sensor, a sensor control unit, and a display unit is disclosed. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the 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: An integrated passive wireless chip diagnostic sensor system is described that can be interrogated remotely with a wireless device such as a modified cell phone incorporating multi-protocol RFID reader capabilities (such as the emerging Gen-2 standard) or Bluetooth, providing universal easy to use, low cost and immediate quantitative analyses, geolocation and sensor networking capabilities to users of the technology. The present invention can be integrated into various diagnostic platforms and is applicable for use with low power sensors such as thin films, MEMS, electrochemical, thermal, resistive, nano or microfluidic sensor technologies.

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: 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: Generally, embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have improved signal response and stability by inclusion of a coating including a hydrogel, a crosslinker, and a swelling modulator, where the coating is disposed proximate to a working electrode of in vivo and/or in vitro analyte sensors, e.g., continuous and/or automatic in vivo monitoring using analyte sensors and/or test strips. Also provided are systems and methods of using the, for example electrochemical, analyte sensors in analyte monitoring.

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

Abstract: Methods and systems for monitoring a well-being of a target are disclosed. In a method embodiment, data representing a process electric potential signal is received by a computer system. The process electric potential signal may be generated at least in part by one or more electric potential sensors in response to the detection of a change in an electric field of a target spaced apart from the one or more electric potential sensors. The method may further include identifying, using the computer system and based at least in part on the data electronically received by the computer system, a recurring pattern in the received data. The method may also include determining, using the computer system and based at least in part on the received data, whether a deviation from the recurring pattern transgresses a threshold. The deviation may comprise a subset of the data electronically received by the computer 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: An electrochemical test sensor for detecting the concentration of an analyte in a fluid sample. The electrochemical test sensor includes a housing that has a first end and a second opposing end. The housing includes an opening at the first end to receive a fluid test sample. An electrode assembly includes a substrate, a working electrode, a counter electrode and a reagent. The substrate has a first surface and an opposing second surface. The working electrode is disposed on the first surface of the substrate, and the counter electrode is disposed on the second surface of the substrate. The electrode assembly is positioned within the housing to define a reaction channel. The electrochemical test sensor may be used with a removable lancet mechanism or integrated within a lancet mechanism to form one integral unit.

Abstract: Correction for initial variation in thickness of a polymer layer and for changes in the coating thickness that occur after implantation of a biosensor and therefore provides substantial increase in the accuracy and lifetime of implantable sensors is done using a factor derived from the decay of potential.

Abstract: One or more therapeutic fluids, such as for example insulin can be delivered to a body. In addition or alternatively, the concentrations of one or more analytes can be measured in vivo. A feedback process can be used to regulate levels of the one or more analytes based on the measurements via delivery of the one or more therapeutic fluids. Related systems, apparatus, methods, and/or articles are also described.

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: Methods, structures, devices and systems are disclosed for fabricating and implementing electrochemical biosensors and chemical sensors. In one aspect, a method of producing an epidermal biosensor includes forming an electrode pattern onto a coated surface of a paper-based substrate to form an electrochemical sensor, the electrode pattern including an electrically conductive material and an electrically insulative material configured in a particular design layout, and attaching an adhesive sheet on a surface of the electrochemical sensor having the electrode pattern, the adhesive sheet capable of adhering to skin or a wearable item, in which the electrochemical sensor, when attached to the skin or the wearable item, is operable to detect chemical analytes within an external environment.

Abstract: Wearable apparatus for monitoring various physiological and environmental factors are provided. Real-time, noninvasive health and environmental monitors include a plurality of compact sensors integrated within small, low-profile devices, such as earpiece modules. Physiological and environmental data is collected and wirelessly transmitted into a wireless network, where the data is stored and/or processed.

Abstract: A method and an apparatus for measuring glucose level in the body fluid of a subject, typically blood glucose level, by measuring impedance of a body tissue, with two pairs of electrodes, two electrodes for injecting current into a body tissue and two electrodes for detecting the ensuing voltage of the body tissue. The body tissue is typically a sub-dermal or sub-cutaneous tissue. The measured impedance of the body tissue is used to correlate with directly determined glucose levels to determine the glucose level from the measured impedance. It is thus possible to determine body fluid glucose levels in a reliable and reproducible manner.

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: 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 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: A body-mountable pyruvate sensing device includes an electrochemical sensor embedded in a polymeric material configured for mounting to a surface of an eye. The electrochemical sensor includes a working electrode, a reference electrode, and a reagent localized near the working electrode that selectively reacts with pyruvate. Application of a voltage between the working electrode and the reference electrode causes a current related to a concentration of pyruvate in a fluid to which the electrochemical sensor is exposed; the current is measured by the body-mountable device and wirelessly communicated.

Abstract: An implantable biocompatible biosensor is described herein. The biosensor includes a chip layer including a plurality of holes fabricated vertically there through, a power source, one or more sensors on the chip layer and coupled to the power source and a hydrogel matrix including one or more angiogenesis stimulating factors in contact with the chip layer. The stimulating factors stimulate growth of organic material through the plurality of holes when the biosensor is implanted in a subject.

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: The present invention provides methods of notifying a user of a smartphone event through use of an energizable ophthalmic lens. In some embodiments, the smartphone may be paired with a specified ophthalmic lens, wherein the pairing may limit wireless communication to communication between the two specified devices. The smartphone may transmit smartphone event data, which may activate an indicator in the ophthalmic lens. In some embodiments, the user may respond to the notification of the smartphone event. The response may trigger an internal action within the ophthalmic lens, or the response may be transmitted to the smartphone, triggering an action in the smartphone. The present invention further describes a method of using an ophthalmic lens with a smartphone event indicator, including methods of pairing an ophthalmic lens with the specified smartphone.

Abstract: An apparatus, systems, and methods related to determining an identity and a concentration of an intravenous fluid. The apparatus, the systems, and the methods described herein may provide near real-time monitoring and/or determination of an identity of components of the intravenous fluid. A concentration and the identity of all of the components of the intravenous fluid may be identified simultaneously.

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 mountable device includes a bio-compatible structure embedded in a polymer that defines at least one mounting surface. The bio-compatible structure includes an electronic component having electrical contacts, sensor electrodes, and electrical interconnects between the sensor electrodes and the electrical contacts. The bio-compatible structure is fabricated such that it is fully encapsulated by a bio-compatible material, except for the sensor electrodes. In the fabrication, the electronic component is positioned on a first layer of bio-compatible material and a second layer of bio-compatible material is formed over the first layer of bio-compatible material and the electronic component. The electrical contacts are exposed by removing a portion of the second layer, a conductive pattern is formed to define the sensor electrodes and electrical interconnects, and a third layer of bio-compatible material is formed over the conductive pattern.

Abstract: Wireless molecular sensor methods and systems integrate radio frequency (RF) technology to interrogate, power, operate and/or readout signals corresponding to levels of molecules of interest from microelectromechanical systems (MEMS) implanted within the body. Various alternative embodiments are disclosed.

Abstract: Embodiments of the invention provide analyte sensors and sensor systems such as amperometric glucose sensors used in the management of diabetes as well as optimized methods for monitoring analytes using such sensors and sensor systems.

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

Abstract: A microsensor and method of manufacture for a microsensor, comprising an array of filaments, wherein each filament of the array of filaments comprises a substrate and a conductive layer coupled to the substrate and configured to facilitate analyte detection. Each filament of the array of filaments can further comprise an insulating layer configured to isolate regions defined by the conductive layer for analyte detection, a sensing layer coupled to the conductive layer, configured to enable transduction of an ionic concentration to an electronic voltage, and a selective coating coupled to the sensing layer, configured to facilitate detection of specific target analytes/ions. The microsensor facilitates detection of at least one analyte present in a body fluid of a user interfacing with the microsensor.

Abstract: Sensor elements are provided for determining at least one analyte concentration in a body fluid. The sensor elements are at least partially implantable into a body tissue and have a substrate and at least two electrodes. One electrode is a working electrode having at least one conductive pad applied to the substrate and at least one electrically conductive sensor material is applied to the conductive pad that includes at least one detector substance adapted to perform an electrically detectable electrochemical detection reaction with the analyte. Another electrode is a counter electrode having at least one counter electrode conductive pad applied to the substrate. The sensor elements also include at least one electrically insulating material that surrounds at least the counter electrode on all sides, where a height of the electrically insulating material at least equals a height of the counter electrode conductive pad.

Abstract: A calibration system is disclosed for calibrating a first physiological monitoring device using a second physiological monitoring device. The first physiological monitor measures a first indication of a physiological parameter. The second physiological monitor measures a second indication of the physiological parameter. The first and second indications are used to calibrate the first physiological monitoring device.

Abstract: In aspects of the present disclosure, a no coding blood glucose monitoring unit including a calibration unit is integrated with one or more components of an analyte monitoring system to provide compatibility with in vitro test strip that do not require a calibration code is provided. Also disclosed are methods, systems, devices and kits for providing the same.

Abstract: The invention provides a device for contacting a surface of a tissue within a patient's body to determine a physiologic parameter of the patient. The device typically comprises a sensor responsive to the physiologic parameter and a probe housing the sensor. The probe is constructed to allow the sensor to be secured at a sensing area adjacent to a surface of a patient's tissue, without need for an adhesive and without disturbing the blood flow within the measurement region of the tissue. The device may also include a means for reducing interference in the sensing area. Preferably, the device further comprises an indicating means operably connected to the sensor for indicating an analyte quantity and/or concentration associated with the physiologic parameter. The invention also provides a method for determining a physiologic parameter of a patient.

Abstract: A monitoring device which measures numerical value information on a subject substance in a body fluid has an electrochemical sensor including a sensor unit for detecting the subject substance which is used in the way of being embedded subcutaneously and generating an electric signal correlating to the numerical value information on the subject substance, and a temperature control unit which adjusts the detected ambient temperature as a temperature ambient to a sensor unit when detecting the subject substance so as to reach a target setting temperature when measuring the subject substance.

Abstract: The present invention relates to a biological information measurement device and a biological information measurement method using the same, and is intended to allow appropriate measurement to be carried out. In the biological information measurement device of the present invention, a control unit 18 is allowed to execute a pre-processing voltage application mode A and a biological information measurement mode C. Furthermore, in the biological information measurement device of the present invention, the hematocrit value of blood is calculated in either the pre-processing voltage application mode A or the biological information measurement mode C, and according to the hematocrit value thus calculated, the duration for applying a measuring voltage upon and after the calculation of the hematocrit value is modified.

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: Method and apparatus for receiving a first signal from a first working electrode of a glucose sensor positioned at a first predetermined position under the skin layer, receiving a second signal from a second working electrode of the glucose sensor positioned at a second predetermined position under the skin layer, the second signal received substantially contemporaneous to receiving the first signal, detecting a dropout in the signal level associated with one of the first or second signals, comparing the first signal and the second signal to determine a variation between the first and second signals, and confirming one of the first or second signals as a valid glucose sensor signal output when the determined variation between the first and the second signals is less than a predetermined threshold level are provided.

Abstract: A method for making a dry sensor element for an enzymatic determination of an analyte in a body fluid includes providing a substrate, producing a working electrode on the substrate, producing a counter electrode on the substrate, and producing electric connectors on the substrate connected to the working electrode and the counter electrode, the step of producing the working electrode further comprising depositing an active enzymatic electrode layer containing an enzyme and a catalyzer material for catalyzing an enzymatic determination of an analyte of a body fluid, the catalyzer material comprising at least one of metal nano-particles and metal oxide nano-particles. A dry sensor element for an enzymatic determination of an analyte in a body fluid is also disclosed.

Abstract: A sensor cartridge comprising a sterile capsule. The sensor cartridge further comprises a sensor within the sterile capsule. The sensor cartridge further comprises a sensor connector connected to the sensor in an initial position. The sensor cartridge further comprises an insertion needle for inserting the sensor into a subject. The insertion needle is within the sterile capsule. The sensor cartridge further comprises a sensor mounting unit for receiving the sensor connector at a mounted position. The sensor mounting unit comprises an adhesive surface for attaching to an exterior surface of the subject. The sensor cartridge further comprises an insertion mechanism operable for actuating the insertion needle and moving the sensor connector from the initial position to the mounted position.

Abstract: Generally, embodiments of the invention relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have improved uniformity of distribution of one or more components of the sensor by inclusion of a low surface tension polymer leveling agent, where the components are disposed proximate to a working electrode of in vivo and/or in vitro analyte sensors, e.g., continuous and/or automatic in vivo monitoring using analyte sensors and/or test strips. Also provided are systems and methods of using the, for example electrochemical, analyte sensors in analyte monitoring.

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: Generally, embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have improved uniformity of distribution of the sensing layer by inclusion of a high-boiling point solvent, where the sensing layer is disposed proximate to a working electrode of in vivo and/or in vitro analyte sensors, e.g., continuous and/or automatic in vivo monitoring using analyte sensors and/or test strips. Also provided are systems and methods of using the, for example electrochemical, analyte sensors in analyte monitoring.

Abstract: Disclosed is an assembly for use with a portable therapeutic device. The assembly includes a mounting housing securable to skin of a patient, and a cannula subcutaneously insertable through a passageway provided within the housing. The cannula is configured to be inserted subsequent to securing of the housing to the skin of the patient.

Abstract: A surgical introducer including a body portion, a shaft and a sensor is disclosed. The body portion includes a reference indicator. The shaft defines a longitudinal axis and is positionable adjacent the body portion. The shaft is rotatable with respect to the body portion and includes a longitudinal indicator and a circumferential indicator. The sensor is disposed in mechanical cooperation with a distal portion of the shaft and is adapted to provide physiological data pertaining to a surgical worksite. At least a portion of the sensor is substantially aligned with the circumferential indicator. Rotation of the shaft with respect to the body portion causes displacement between the circumferential indicator and the reference indicator. Longitudinal movement of the shaft with respect to the body portion causes displacement between the longitudinal indicator and the reference indicator.

Abstract: Disclosed are embodiments that relate to algorithms and methods for calibrating an analyte sensor, and more particularly, to algorithms for calibrating an optical glucose sensor comprising an equilibrium fluorescent chemical indicator system. In particular, a method of detecting an analyte concentration is disclosed where a modified Michaelis-Menten equation comprising Michaelis-Menten parameters is used to characterize the signal generated by the analyte sensor.

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: 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.