Abstract: Embodiments of the present invention provide a device and method for treating animal skin to produce tautness in the skin during the insertion of an analyte sensor. A device in accordance with embodiments of the present invention includes a housing that partially encloses a cavity and is adapted for mounting onto animal skin and a sensor insertion module adapted to insert an analyte sensor through animal skin.

Abstract: Embodiments of the present invention provide methods, apparatuses, and systems associated with detecting, monitoring, analyzing, and/or displaying analyte level trends in a body. In an embodiment, there is provided a method comprising obtaining a plurality of analyte measurements from a body using an analyte sensing device, and selecting two or more measurements of the plurality of measurements to calculate and display on a device associated with the analyte sensing device a rate of change of the analyte over a period of time spanning the two or more measurements.

Abstract: Embodiments of the present invention provide an adhesive overbandage. In an embodiment, there is provided an adhesive overbandage for use with a biosensor. An exemplary overbandage comprises a frame having an upper surface, a lower surface, an outer boundary and an inner boundary, wherein the inner boundary defines an interior opening configured to receive a monitoring device, adhesive disposed on the lower surface of the frame, and a release liner removably coupled to the adhesive.

Abstract: Embodiments of the present invention provide an analyte sensing device having one or more sensing electrodes. In embodiments, each sensing electrode may serve as an anode, a cathode, or a combination of an anode and cathode. In embodiments, there may be any suitable number of electrodes. Related analyte sensor insertion aids and methods of using the disclosed embodiments are also provided.

Abstract: Embodiments of the present invention provide adhesives comprising additives, such as anti-inflammatory and antiperspirant additives, to address various problems a user may encounter when contacting the adhesive or wearing a bandage or other device/substrate using such an adhesive.

Abstract: A device, system, and method for delivering a device such as a sensor or fluid transport structure or a fluid transport structure sensor combination into, for example, mammalian skin and receiving, analyzing, and displaying signals from the device such as a sensor are disclosed. A system in accordance with embodiments of the present invention includes a reusable sensor assembly including a transmitter, microcontroller, and housing plus disposable sensor assembly including a housing having an opening for receiving both the distal end of a biosensor, a sensor insertion guidance structure, and a transmission apparatus for transmitting signals received from the sensor to a reusable sensor assembly for transmission to an external electronic monitoring unit.

Abstract: A device and method for delivering a device such as a sensor or fluid transport structure or a fluid transport structure sensor combination into, for example, animal skin. Such a device utilizes an introducer device such as a needle or trocar to puncture skin and allow a sensor to enter through the resultant skin puncture. A device in accordance with embodiments of the present invention includes a housing for mounting to animal skin including an opening for receiving both the distal end of an analyte sensor and the end of an introducer, an actuator device for forcing the introducer from a first position within the housing, through the exit port to a second position, with sufficient force to puncture skin.

Abstract: Embodiments of the present invention provide methods, apparatuses, and systems associated with detecting, analyzing, and/or displaying historical glucose levels and/or trends in a body.

Abstract: Embodiments of the present invention teach the use of shape recognition methods, apparatuses, and systems to classify the shape of one or more recent glucose trends during continuous glucose monitoring and to warn the user when specific shapes or trends are identified. Using such embodiments, patients with diabetes may be warned before they become overtly hypoglycemic or hyperglycemic.

Abstract: A device and method for delivering a device such as a sensor or fluid transport structure or a fluid transport structure sensor combination into, for example, mammalian skin. Such a device allows a sensor to penetrate mammalian skin without the use of an introducer device such as a needle. A device in accordance with embodiments of the present invention includes a housing for attachment to mammalian skin including an exit port for receiving the distal end of a biosensor and an injection activation device including a mechanism for forcing the sensing device from a first position within the housing, through the exit port to a second position, with sufficiently high velocity to partially penetrate the mammalian skin.

Abstract: Embodiments of the present invention provide for raising a background current setting for a biosensor above the actual (measured) background current present (i.e., overestimating the background current), particularly in the hypoglycemic range, to improve sensor accuracy and decrease the chance of glucose value overestimation by the sensor.

Abstract: Embodiments of the present invention provide methods, apparatuses, and systems for sensing analyte with devices having antimicrobial properties. Embodiments of the present invention provide specialized coatings or specialized materials that reduce the risk of tissue infection around biosensors that reside fully or partially within subcutaneous tissue or within a blood vessel.

Abstract: A sensing element adapted to, at least in part, be inserted into a mammalian body. The sensing element is made up of a core of a structurally robust metal and a plated portion made of an electrochemically active metal conjoined to at least a portion of the core. This sensing element may be used as part of a method for the continuous or intermittent monitoring of an analyte within a mammalian body. The method includes inserting at least a portion of the sensing element into the mammalian body and measuring any electric current produced by at least of portion of the sensor.

Abstract: A method of measuring an analyte concentration in body fluid in an animal body having skin and subcutaneous soft tissue that includes body fluid. The method comprises, introducing a portion of an analyte-measuring device into the subcutaneous soft tissue. The analyte-measuring device includes an analyte sensing element, having a sharpened distal end to facilitate introduction into the animal body. Additionally the sensing element has an indicating electrode that is adapted to be activated by electric power and to form a raw analyte measurement, when it is activated and in contact with the body fluid, in less than two minutes. The sensing device further has a reference electrode and an electric power and display device that is adapted to mate to the analyte-sensing element. The power and display device activates the analyte-sensing element by applying electric power to it.

Abstract: A method of making a multiple use analyte sensing assembly. The method includes placing a coated wire analyte sensing assembly on an article having a surface that defines a set of pockets so that the wire extends into each pocket. The coated wire is then typically covered by a layer of insulation material between pockets, either by placing an apertured insulation material layer over the pockets so that the apertures correspond to the pockets or by placing a liquid curable insulation material over the coated wire between pockets.

Abstract: Embodiments of the present invention provide methods and apparatuses for telemetry, more specifically, methods and apparatuses for providing telemetry in association with medical devices. Exemplary embodiments of the present invention provide continuous telemetry between a transmitter and a monitoring unit, for example in a medical monitoring environment.

Abstract: Embodiments of the present invention provide for analyte sensor introducing assemblies. A transcutaneous introducer assembly is provided, comprising a module base adapted for mounting onto an animal's skin, and supporting an electrical network; a handle defining an interior volume; a hollow introducer, having a slot extending at least partially along the length thereof, carried by and extending from the handle in a predetermined orientation, a sensor residing in the hollow introducer prior to and during insertion; and a retraction mechanism adapted to retract and remove the handle and, optionally, the introducer from the module base and the sensor.

Abstract: Embodiments of the present invention improve the accuracy of measurements and/or in vivo calibrations of a biosensor by (1) using more than one sensor signal value and/or more than one directly sampled and measured value, such as a capillary blood glucose value, and/or by (2) delaying the acquisition of a sensor output value that is compared with a directly sampled and measured value, such as a capillary blood glucose value, during a calibration. In an embodiment of the present invention, the median of a series of measured values, or a median or mean of the medians, may be utilized to provide more consistent and accurate measurement data and/or to compensate for error or artifact.

Abstract: A method of addressing a condition of a living body comprising the steps of using an energy beam to form a set of pores in a work piece biocompatible membrane. The pores should have a mean area of less than 500 ?m through the biocompatible membrane, thereby producing a microporous membrane adapted to facilitate tissue in growth. This membrane is placed at least partially about an article that is adapted to be implanted in a living body, which is implanted into the living body, thereby addressing the condition.

Abstract: A sensing element adapted to, at least in part, be inserted into a mammalian body. The sensing element is made up of a core of a structurally robust metal and a plated portion made of an electrochemically active metal conjoined to at least a portion of the core. This sensing element may be used as part of a method for the continuous or intermittent monitoring of an analyte within a mammalian body. The method includes inserting at least a portion of the sensing element into the mammalian body and measuring any electric current produced by at least of portion of the sensor.