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 a 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: Embodiments provide a method and related systems that take into account the difference between a measured glucose value and the calibration level and the amount of elapsed time since the prior calibration. As one or both of these determined differences increases, the desirability of an additional calibration also increases. The methodology described herein thus analyzes the combination of change in glucose level as well as the time since the prior calibration. If the combination exceeds a predetermined value, the system recommends, but does not require, that the subject user perform an additional calibration.

Abstract: Systems and techniques for command communication between wireless devices are described. In one implementation, a data gathering device (such as a continuous glucose monitor) and a monitoring/control device, which communicate data samples through a frequency hopping protocol, utilize a dedicated command frequency for the transmission of non-data instructions and acknowledgements. A command mode is described where the command frequency is regularly listened to by a device to determine if pairing or other instructions are being sent. In another example, when communications are disrupted or corrupted, the devices revert to using the command frequency in order to reacquire a paired link between the devices. The command frequency is also used for a flight mode, where the data-acquisition device goes into a low-, or no-power transmission mode and remains in the mode, storing sampled data, until instructed to leave the flight mode over the command frequency.

Abstract: Embodiments herein provide an analyte sensor subassembly that provides an integrated structure enabling suitably secure electrical contact between an analyte sensor and the electronic components of an analyte sensor assembly. An analyte sensor subassembly assists the process of inserting the sensor into skin. An analyte sensor subassembly may operate in concert with one or more sensor insertion tools to provide insertion of an analyte sensor into the skin of a subject/patient. Associated devices, such as channel guides and sensor insertion tools, are also provided, as are methods of operation and sensor insertion.

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 disclosure 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: 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: 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 provide an analyte sensing device having one or more indicating electrodes adapted for long-term use within an individual. An indicating electrode coupled with a reference electrode may be inserted within or below the dermis of an individual and may be electrically coupled to an external sensor unit. Related analyte sensor insertion aids and methods of using the disclosed embodiments are also provided.

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: 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 provide a method and related systems that take into account the difference between a measured glucose value and the calibration level and the amount of elapsed time since the prior calibration. As one or both of these determined differences increases, the desirability of an additional calibration also increases. The methodology described herein thus analyzes the combination of change in glucose level as well as the time since the prior calibration. If the combination exceeds a predetermined value, the system recommends, but does not require, that the subject user perform an additional calibration.

Abstract: A multiple use analyte sensing assembly that includes a long, thin conductor. A plurality of sensing sites are spaced along the conductor and each sensing site includes a membrane system adapted to create a current when placed into contact with body fluid containing the analyte. The assembly also includes a housing, having an aperture, an uptake spool and a payout spool, the conductor being wrapped about the payout spool before the sensing assembly is used. A sensor positioning actuator turns the uptake spool to move each sensing site, in sequence, to the housing aperture and then to the uptake spool. The assembly also includes a skin broaching assembly, having a multiplicity of lancets and a lancet positioning actuator adapted to move each lancet to the aperture. In addition, a lancet use actuator is adapted to move each lancet at least partially through the aperture and then back again.

Abstract: Embodiments provide a sensor insertion tool (SIT) that provides a motive force for insertion of an analyte sensor into/through skin. A SIT may be releasably locked to one or more components of a sensor insertion system, such that components of the sensor insertion system remain securely coupled during sensor insertion. A SIT may include a release member that unlocks or uncouples the SIT and the other components after sensor insertion. In various embodiments, a SIT may be a component of a sensor insertion system configured for assembly by an end user, a health care professional, and/or a caretaker prior to sensor insertion, and may act in cooperation with other sensor insertion system components. Additional components and methods of assembly and use are also provided herein.

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 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 various multipolymers and permselective membranes for use with biosensors and other implantable medical devices and prostheses. Embodiments of the present invention may provide structural strength and integrity, and further may control the influx of glucose, oxygen and/or water. Embodiments of the present invention may, for example, minimize or reduce the influx of glucose by minimizing the percentage of hydrophilic segments, which in turn minimizes the percentage of water uptake and the degree of glucose transport.

Abstract: Systems and techniques for command communication between wireless devices are described. In one implementation, a data gathering device (such as a continuous glucose monitor) and a monitoring/control device, which communicate data samples through a frequency hopping protocol, utilize a dedicated command frequency for the transmission of non-data instructions and acknowledgements. A command mode is described where the command frequency is regularly listened to by a device to determine if pairing or other instructions are being sent. In another example, when communications are disrupted or corrupted, the devices revert to using the command frequency in order to reacquire a paired link between the devices. The command frequency is also used for a flight mode, where the data-acquisition device goes into a low-, or no-power transmission mode and remains in the mode, storing sampled data, until instructed to leave the flight mode over the command frequency.

Abstract: Embodiments herein provide an analyte sensor subassembly that provides an integrated structure enabling suitably secure electrical contact between an analyte sensor and the electronic components of an analyte sensor assembly. An analyte sensor subassembly assists the process of inserting the sensor into skin. An analyte sensor subassembly may operate in concert with one or more sensor insertion tools to provide insertion of an analyte sensor into the skin of a subject/patient. Associated devices, such as channel guides and sensor insertion tools, are also provided, as are methods of operation and sensor insertion.

Abstract: A method of creating an analyte sensor. The method starts with the step of providing an electrochemically active surface. Then, at least one nub made of dielectric material and extending transversely outwardly from the electrochemically active surface is created. A curable liquid is applied to the electrochemically active surface and the nub and is then cured. In this process, the nub, which could be one of several nubs, serves to support the liquid before and during the curing.

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.