Abstract: Methods and devices to continuously measure electrochemical activity of one or more biochemical or molecular markers (FIG. 9). A substrate having electronics for measuring electrochemical activity and a plurality of electrodes such that the electrodes are in contact with the subcutaneous layer are attached to subject's skin or intravenously. The devices measure a biochemical process associated with one or more biochemical or molecular markers in vivo by detecting an electrochemical signal in subcutaneous layer (or intravenously) using the plurality of electrodes.

Abstract: Novel methods and systems for monitoring the health of an eye are disclosed. For example, a resonant circuit may be fabricated on a contact lens and this circuit may be coupled to a second circuit having the same resonant current frequency. A change in a property of the eye fluid contacted by the sensor in the contact lens is communicated to an external device and a remedying action is suggested to the wearer.

Abstract: Method and system for determining real time analyte concentration including an analyte sensor having a portion in fluid contact with an interstitial fluid under a skin layer, an on-body electronics including a housing coupled to the analyte sensor and configured for positioning on the skin layer, the on-body electronics housing including a plurality of electrical contacts, on the housing; and a data analysis unit having a data analysis unit housing and a plurality of probes, on the housing. Each of the probes configured to electrically couple to a respective electrical contact when the data analysis unit is positioned in physical contact with the on-body electronics. The one or more signals on the probes correspond to one or more of a substantially real time monitored analyte concentration level (MACL), MACL over a predetermined time period, or a rate of change of the MACL, or combinations thereof, are provided.

Abstract: A body fluid testing device has at least one penetrating member and a penetrating member driver configured to be coupled to the at least one penetrating member. A plurality of analyte sensors are coupled to a spoked disk substrate. Each of a penetrating member can pass between spokes of the disk substrate to provide that a used penetrating member can be removed and a new penetrating inserted without removing the disk. A disposable houses the at least one penetrating member and the plurality of analyte sensors.

Abstract: Ingestible event marker systems that include an ingestible event marker (i.e., an IEM) and a personal signal receiver are provided. Embodiments of the IEM include an identifier, which may or may not be present in a physiologically acceptable carrier. The identifier is characterized by being activated upon contact with a target internal physiological site of a body, such as digestive tract internal target site. The personal signal receiver is configured to be associated with a physiological location, e.g., inside of or on the body, and to receive a signal the IEM. During use, the IEM broadcasts a signal which is received by the personal signal receiver.

Abstract: A mountable device includes a bio-compatible structure embedded in a polymer that defines at least one mounting surface. The bio-compatible structure has a first side defined by a first layer of bio-compatible material, a second side defined by a second layer of bio-compatible material, an electronic component, and a conductive pattern that defines sensor electrodes. A portion of the second layer of bio-compatible material is removed by etching to create at least one opening in the second side in which the sensor electrodes are exposed. The etching further removes a portion of the first layer of bio-compatible material so as to create at least one opening in the first side that is connected to the at least opening in the second side. With this arrangement of openings, analytes can reach the sensor electrodes from either the first side or the second side of the bio-compatible structure.

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

Abstract: An apparatus for sensing multiple parameters includes an implantable housing and a plurality of implantable sensors disposed within the implantable housing. The plurality of implantable sensors sense parameters in a patient, such as biological or physiological parameters, for example, and each responds to an analyte in the patient. The plurality of implantable sensors may include, but is not limited to, electrochemical, potentiometric, current and optical sensors.

Abstract: The invention generally relates to a sensor system. In particular to a sensor for glucose monitoring. The invention also also relates to an arrangement and a method for monitoring a constituent and in particular glucose in body tissue using a sensor system.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. 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, such as blood glucose. An inserter having a retractable introducer is provided for subcutaneously implanting the sensor in a predictable and reliable fashion.

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

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

Abstract: Methods and systems for providing continuous analyte monitoring including in vivo sensors that do not require any user calibration during in vivo use are provided. Also provided are methods and devices including continuous analyte monitoring systems that include in vivo sensors which do not require any system executed calibration or which do not require any factory based calibration, and which exhibit stable sensor sensitivity characteristics. Methods of manufacturing the no calibration sensors and post manufacturing packaging and storage techniques are also provided.

Abstract: An analyte sensor for the continuous or semi-continuous monitoring of physiological parameters and a method for making the analyte sensor are disclosed. The analyte sensor includes a crosslinked copolymer network in contact with a surface of an electrode. The copolymer network has voids formed by the removal of a porogen, and an analyte sensing component is immobilized within the network. The method involves forming a solution of the precursors of the copolymer, depositing the mixture on a surface of an electrode, and curing the deposited mixture to provide the analyte sensor.

Abstract: An electrode system is disclosed for measuring a concentration or presence of an analyte under in-vivo conditions, where the electrode system includes at least one electrode with immobilized enzyme molecules and an improved diffusion barrier that controls diffusion of the analyte from body fluid surrounding the electrode system to the enzyme molecules. The diffusion barrier includes a hydrophilic polyurethane or a block copolymer having at least one hydrophilic block and at least one hydrophobic block. The electrode system also can include a spacer membrane that includes a hydrophilic copolymer of acrylic and/or methacrylic monomers.

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: Systems and methods for multiple analyte analysis are provided. In one embodiment, a method includes determining concentrations of first and second analytes in a sample. The first and second analytes may be, for example, glucose and hydroxybutyrate. In this form, an indication related to the measured concentration of hydroxybutyrate is provided in response to determining that the concentration of hydroxybutyrate is above a predetermined value. In a further aspect of this form, a quantitative indication representative of the measured glucose concentration is automatically provided regardless of the value of the measured glucose concentration. In another embodiment, a system includes a meter configured to interact with a test element to assess first and second analytes in a sample. Further embodiments, forms, objects, features, advantages, aspects, and benefits shall become apparent from the description and drawings.

Abstract: In aspects of the present disclosure, a multi compatible or universal 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 require calibration code and test strips that do not require calibration code. Also disclosed are methods, systems, devices and kits for providing the same.

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: An anti-fouling sleeve for an endotracheal tube, a method of placement, and the tools for placement. The anti-fouling sleeve occupies the entire length of endotracheal tube, and can be installed permanently or made removable and disposable. The sleeve may be instrumented with sensors and/or a UV light source to reduce and potentially eliminate biofilm formation. Once placed inside the endotracheal tube the sleeve expands to conform to the inner diameter of the tube. After use, any accumulated biofilm on the inner portion of the sleeve is removed leaving the inner portion of the endotracheal tube essentially sterile.

Abstract: The present disclosure provides a sensor port configured to receive a plurality of analyte sensors having different sizes, shapes and/or electrode configurations. Also provided are analyte meters, analyte monitoring devices and/or systems and drug delivery devices and/or systems utilizing the disclosed sensor ports.

Abstract: Various systems and methods of operating an analyte measurement device is provided. The device has a display, user interface, processor, memory and user interface buttons. In one example, one of the methods can be achieved by measuring an analyte with the analyte measurement device; displaying a value representative of the analyte; prompting a user to activate a test reminder; and activating the test reminder to remind a user to conduct a test measurement at a different time. Other methods and systems are also described and illustrated.

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, 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: An eye-mountable 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 that selectively reacts with an analyte to generate a sensor measurement related to a concentration of the analyte in a fluid to which the eye-mountable device is exposed. The working electrode can have a first side edge and a second side edge. The reference electrode can be situated such that at least a portion of the first and second side edges of the working electrode are adjacent respective sections of the reference electrode.

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: Disclosed herein is an analyte sensing device capable of continuously monitoring metabolic levels of a plurality of analytes. The device comprises an external unit, which, for example, could be worn around the wrist like a wristwatch or could be incorporated into a cell phone or PDA device, and an implantable sensor platform that is suitable, for example, for implantation under the skin. The external device and the internal device are in wireless communication. In one embodiment, the external device and the internal device are operationally linked by a feedback system. In one embodiment, the internal device is encapsulated in a biocompatible coating capable of controlling the local tissue environment in order to prevent/minimize inflammation and fibrosis, promote neo-angiogenesis and wound healing and this facilitate device functionality.

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

Abstract: Tissue-integrating electronic apparatuses, systems comprising such apparatuses and methods of using these apparatuses and systems for the detection of one or more signals are provided.

Abstract: The present invention relates to a method for wireless transmission of data between components of a blood glucose system (1, I1) including 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). The slave device (3) is normally operated in a power saving mode and 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) via 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: Described here are embodiments of processes and systems for the continuous manufacturing of implantable continuous analyte sensors. In some embodiments, a method is provided for sequentially advancing an elongated conductive body through a plurality of stations, each configured to treat the elongated conductive body. In some of these embodiments, one or more of the stations is configured to coat the elongated conductive body using a meniscus coating process, whereby a solution formed of a polymer and a solvent is prepared, the solution is continuously circulated to provide a meniscus on a top portion of a vessel holding the solution, and the elongated conductive body is advanced through the meniscus. The method may also comprise the step of removing excess coating material from the elongated conductive body by advancing the elongated conductive body through a die orifice.

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: A fully integrated small size implantable sensing device is described, which can include a sensor and an electronic circuit to interface with the sensor and communicate with an external device. Various fabrication methods for the sensing device are described, including provision of wells, created using same fabrication technology as the electronic circuit, to contain electrodes of the sensor and corresponding functionalization chemicals. Such implantable sensing device can be used for a variety of electrochemical measuring applications within a living body as well as actuation by injecting a current into the living body.

Abstract: Methods, structures, and systems are disclosed for biosensing and drug delivery techniques. In one aspect, a? device for detecting an analyte and/or releasing a biochemical into a biological fluid can include an array of hollowed needles, in which each needle includes a protruded needle structure including an exterior wall forming a hollow interior and an opening at a terminal end of the protruded needle structure that exposes the hollow interior, and a probe inside the exterior wall to interact with one or more chemical or biological substances that come in contact with the probe via the opening to produce a probe sensing signal, and an array of wires that are coupled to probes of the array of hollowed needles, respectively, each wire being electrically conductive to transmit the probe sensing signal produced by a respective probe.

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: The estimation of the variation of the glucose level in the blood of a person by the variation of the volume of the interstitial fluid compartments in muscular tissue due to a shift of fluid between the extracellular and intracellular compartments caused by variations of the osmotic pressure of the extracellular fluids which is in turn correlated with the glucose level. The variation of the volume of the interstitial fluid compartments is detected by a non-invasive conductometry measurement using electrodes placed in contact with the skin of the person overlying a portion of soft tissue including muscular fibers. To eliminate the adverse effect of the conductivity of the capillary vessels, the conductivity of the tissue is measured independently in two directions, namely parallel and transverse to the muscular fibers.

Abstract: Carbon nanostructures may be protected and functionalized using a layer-by-layer method whereby functional groups on the carbon nanostructure surface may be further derivatized to incorporate additional functional moieties. Exemplary moieties include redox mediator molecules, crown ethers, catalysts, boric acids, carbohydrates, oligonucleotides, DNA or RNA aptamers, peptide aptamers, proteins such as enzymes and antibodies, quantum dots and nanoparticles, cells, cell organelles, or other cellular components. The density of functional groups or functional moieties on carbon nanostructure surfaces may also be controlled as well as the degree of surface hydrophilicity of the nanostructure.

Abstract: Method and apparatus for channeling fluid away from an insertion site having a channel guiding the fluid flow from the insertion site, and a channeling compartment containing absorbent material to wick the fluid such as blood away from the insertion site is provided.

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 use of electrical impedance spectroscopy to adjust calibration settings in an in vivo monitoring system, such as an in vivo continuous glucose monitoring sensor. The adjustments can compensate for the condition of the sensor membrane in vivo.

Abstract: There are provided a diagnostic module for diagnosing a disease and a disease diagnosis apparatus including the same. The disease diagnosis apparatus includes a patch including one or more diagnostic module attachable-detachable recesses, one or more diagnostic modules detachably attached to the diagnostic module attachable-detachable recesses to collect and analyze blood, and a processor processing analysis results.

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 provides an electrochemical sensor comprising a substrate, an electrically conductive layer made of carbon particles which is disposed on the substrate, a cell membrane mimetic structure layer containing an enzyme at least one of inside the cell membrane mimetic structure layer and on the interface of the cell membrane mimetic structure layer which is disposed on the electrically conductive layer.

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: A mountable device includes a bio-compatible structure embedded in a polymer that defines at least one mounting surface. The bio-compatible structure has a first side defined by a first layer of bio-compatible material, a second side defined by a second layer of bio-compatible material, an electronic component, and a conductive pattern that defines sensor electrodes. A portion of the second layer of bio-compatible material is removed by etching to create at least one opening in the second side in which the sensor electrodes are exposed. The etching further removes a portion of the first layer of bio-compatible material so as to create at least one opening in the first side that is connected to the at least opening in the second side. With this arrangement of openings, analytes can reach the sensor electrodes from either the first side or the second side of the bio-compatible structure.

Abstract: A mountable device includes a bio-compatible structure embedded in a polymer that defines at least one mounting surface. The bio-compatible structure has a first side defined by a first layer of bio-compatible material, a second side defined by a second layer of bio-compatible material, an electronic component, and a conductive pattern that defines sensor electrodes. A portion of the second layer of bio-compatible material is removed by etching to create at least one opening in the second side in which the sensor electrodes are exposed. The etching further removes a portion of the first layer of bio-compatible material so as to create at least one opening in the first side that is connected to the at least opening in the second side. With this arrangement of openings, analytes can reach the sensor electrodes from either the first side or the second side of the bio-compatible structure.

Abstract: The present invention relates to a mental balance or imbalance estimation system (100) and method for estimating a level of mental balance or imbalance of a user (1). The system comprises a skin conductance sensor (20) for sensing the skin conductance of the user (1), the skin conductance over time forming a skin conductance trace (22). The system further comprises a processing unit (10) for receiving and processing the skin conductance trace (22), the processing unit configured to determine at least one stimulus response (24) in the skin conductance trace (22), to determine an estimated cortisol level trace (28) of the user (1) based on the determined at least one stimulus response (24), and to determine the estimated level of mental balance or imbalance of the user (1) based on the estimated cortisol level trace (28).

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.