Abstract: A medicine injection pen includes a body, a drive member within the body and configured to move relative thereto upon actuation, a cartridge housing releasably engageable with the body and configured to retain a medicine cartridge, at least one sensor, and at least one detector. The medicine cartridge has a liquid medicine therein and includes a piston configured to slide therein. The drive member is configured to move relative to the body to urge the piston to slide within the medicine cartridge to dispense at least some of the liquid medicine from the medicine cartridge. The sensor(s) is configured to sense movement of the drive member relative to the body to enable determination of an amount of the liquid medicine dispensed. The detector(s) is configured to detect a gap between the drive member and the piston.

Abstract: Electrical sensing/stimulation apparatuses for positioning at least one electrode within body tissue are provided. An electrical sensing/stimulation apparatus may comprise an elongate lead body having at least one internal lumen, at least one sensing/stimulation electrode, a deployable/retractable displacement member that moves or biases at least one electrode towards a prescribed direction by the user, a tissue attachment mechanism for affixing the distal segment of the device to body tissue, and an atraumatic distal lead body termination. In a retracted configuration, the attachment mechanism is positioned substantially within the distal segment of the lead body, and in the deployed configuration, the attachment mechanism extends from the axis of the lead body to engage body tissue.

Abstract: Embodiments of the invention provide compositions useful in implantable devices such as analyte sensors as well as methods for making and using such compositions and devices. In typical embodiments of the invention, the device is a glucose sensor comprising a polymeric composition disposed on a flexible assembly within the sensor that includes amounts of one or more immunosuppressant agents designed to provide such sensors with improved material properties such as enhanced biocompatibility.

Abstract: A medical device includes a sensor to observe a characteristic of an anatomy, and a sensor base coupled to the sensor. The medical device includes a coupling system to couple the sensor base to the anatomy. The coupling system includes a first adhesive member and a second adhesive member. The first adhesive member is coupled to the sensor base and the second adhesive member is to couple to the anatomy. The second adhesive member includes at least one cut-out to direct moisture to an ambient environment surrounding the medical device.

Abstract: Methods, systems, and devices for continuous glucose monitoring. More particularly, the methods, systems, and devices describe a working electrode with a GOx sensor and a background electrode in which the background electrode has no GOx sensor. The system may then compare the first signal and the second signal to detect ingestion of a medication by the user. The system may generate a sensor glucose value based on the comparison.

Abstract: An analyte sensor device includes a housing, a sensor, and a printed circuit board assembly (PCBA) within the housing and including a circuit and a first plurality of contacts. The sensor includes a proximal end within the housing and a distal end outside of the housing. The proximal end includes a second plurality of contacts electrically connected to the first plurality of contacts on the PCBA. The distal end includes one or more electrodes configured to measure a concentration level of an analyte in a body of a user. The circuit is operable to detect electrical connection between the first plurality of contacts and the second plurality of contacts within the housing while the distal end of the sensor is outside the body of the user or a fluid.

Abstract: A device for positioning an electrode in tissue includes: a lead body having a distal portion; an electrode array coupled to the lead distal portion; an anchoring element having an anchor tip and being operable in a first configuration in which the anchor tip is retracted within the lead and in a second configuration in which the anchor tip is extended outside the lead and configured to fixate within the tissue; and a displacement mechanism that is actuated to bias the electrode array or the anchoring element toward the tissue. A method for positioning an electrode in tissue includes: navigating, to the tissue, a lead with an electrode array, an anchoring element with a distal anchor tip, and a displacement mechanism; biasing the electrode array and anchoring element towards the tissue with the displacement mechanism; and deploying the anchoring element, and verifying fixation of the anchor tip within the tissue.

Abstract: Embodiments of the invention provide amperometric analyte sensors having optimized elements such as interference rejection membranes, and associated architectures, as well as methods for making and using 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: An analyte sensor apparatus including a sensing portion including one or more electrodes including a working electrode and one or more contacts for electrically connecting the sensor portion to control circuitry (e.g., a printed circuit board assembly, PCBA); and a circuit comprising the one or more contacts; wherein the circuit detects an electrical connection between the control circuitry without requiring exposure of the sensing portion to a fluid.

Abstract: Electrical sensing/stimulation apparatuses for positioning at least one electrode within body tissue are provided. An electrical sensing/stimulation apparatus may comprise an elongate lead body having at least one internal lumen, at least one sensing/stimulation electrode, a deployable/retractable displacement member that moves or biases at least one electrode towards a prescribed direction by the user, a tissue attachment mechanism for affixing the distal segment of the device to body tissue, and an atraumatic distal lead body termination. In a retracted configuration, the attachment mechanism is positioned substantially within the distal segment of the lead body, and in the deployed configuration, the attachment mechanism extends from the axis of the lead body to engage body tissue.

Abstract: Methods, systems, and devices for continuous glucose monitoring. More particularly, the methods, systems, and devices describe a working electrode with a GOx sensor and a background electrode in which the background electrode has no GOx sensor. The system may then compare the first signal and the second signal to detect ingestion of a medication by the user. The system may generate a sensor glucose value based on the comparison.

Abstract: An infusion device configured to implant a cannula and a sensor in a user. The infusion device includes a first unit defining a first housing and a second unit defining a second housing. The second housing is configured to engage the first housing. The infusion device includes a first insertion needle configured to implant the cannula in the user and a second insertion needle configured to implant the sensor in the user when the second unit engages the first unit. The infusion device includes processing circuitry in electrical communication with the sensor and a fluid reservoir in fluid communication with the cannula. In examples, the first unit and the second unit are configured to engage using an inserter.

Abstract: A medical device includes a sensor to observe a characteristic of an anatomy, and a sensor base coupled to the sensor. The medical device includes a coupling system to couple the sensor base to the anatomy. The coupling system includes a first adhesive member and a second adhesive member. The first adhesive member is coupled to the sensor base and the second adhesive member is to couple to the anatomy. The first adhesive member includes at least one cut-out to direct moisture to an ambient environment surrounding the medical device.

Abstract: A sensor assembly for sensing a physiological characteristic of a user includes a power source, a power control switch, and a power latch within a housing. The power control switch is electrically coupled to the power source, and is configured to inhibit delivery of power from the power source to one or more components of the sensor assembly before deployment of the sensor assembly to a user, and deliver power from the power source to the one or more components of the sensor assembly in response to the deployment of the sensor assembly to the user. The power latch is configured to, upon the deployment of the sensor assembly to the user, latch an output of the power control switch to maintain the delivery of power from the power source to the one or more components of the sensor assembly while the sensor assembly is in a deployed state.

Abstract: A sensor assembly for sensing a physiological characteristic includes a power source, a power control switch, and a power latch configured to latch an output of the power control switch. The sensor assembly also includes a power converter coupled to the power control switch. The power converter is configured to step down a voltage of the latched output of the power control switch for delivery of the latched output to one or more components of the sensor assembly. The power control switch is configured to inhibit consumption of power from the power source when the sensor assembly is in a pre-deployment state and output the latched output to the power converter in response to transition of the sensor assembly from the pre-deployment state to a deployed state.

Abstract: Embodiments of the invention provide amperometric analyte sensors having optimized elements such as interference rejection membranes, and associated architectures, as well as methods for making and using 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 sensor assembly for sensing a physiological characteristic includes a power source configured to deliver power to one or more components of an electrical subsystem upon deployment of the sensor assembly to a user. A power latch is configured to latch an output of a power control switch for delivery to one or more components of the electrical subsystem upon deployment of the sensor assembly to a user. The power control switch is configured to inhibit delivery of power to the electrical subsystem prior to deployment of the sensor assembly to a user and to deliver the latched output to one or more components of the electrical subsystem in response to deployment of the sensor assembly to a user.

Abstract: A glucose sensor includes a working electrode configured to provide a current signal (IsigWE1) based on a level of glucose, a background electrode configured to provide a current signal (IsigWE2) based on a presence of an excipient of insulin, and a controller. The controller is configured to monitor the IsigWE1 at the working electrode, monitor the IsigWE2 at the background electrode, monitor at least one electrochemical impedance spectroscopy (EIS) parameter at the working electrode, and calculate a change in the at least one EIS parameter, detect presence of the excipient of insulin based on the change. In a case where the presence of the excipient of insulin is detected, the controller is further configured to compensate the IsigWE1 based on a predetermined relationship between the IsigWE1 and the IsigWE2, and output the compensated IsigWE1 (IsigCOMP).

Abstract: A medical device includes a sensor to observe a characteristic of an anatomy, and a sensor base coupled to the sensor. The medical device includes a coupling system to couple the sensor base to the anatomy. The coupling system includes a first adhesive member and a second adhesive member. The first adhesive member is coupled to the sensor base and the second adhesive member is to couple to the anatomy. The first adhesive member includes at least one cut-out to direct moisture to an ambient environment surrounding the medical device.

Abstract: An infusion device configured to implant a cannula and a sensor in a user. The infusion device includes a first unit defining a first housing and a second unit defining a second housing. The second housing is configured to engage the first housing. The infusion device includes a first insertion needle configured to implant the cannula in the user and a second insertion needle configured to implant the sensor in the user when the second unit engages the first unit. The infusion device includes processing circuitry in electrical communication with the sensor and a fluid reservoir in fluid communication with the cannula. In examples, the first unit and the second unit are configured to engage using an inserter.