Abstract: Embodiments of the invention provide skin adhesive patches designed to ease a diabetic patient's maneuverability and alignment of a glucose sensing device as the patient adheres the device to their skin. Embodiments of the invention can be adapted for use with a wide variety of medical components that are coupled to the skin of patients, including insulin infusion sets, patch pumps, and all-in-one patch sets.

Abstract: An accessory for use with a medicine delivery device includes a body configured to attach to a medicine delivery device and a user interface disposed on the body and configured to communicate information to a user. In aspects, the user interface includes first and second lights configured to be selectively illuminated and a first symbol associated with the first light. The first light and the first symbol together indicate an action to be performed when the first light is illuminated. In aspects, the user interface includes red, yellow, and green lights configured to be illuminated in sequential time periods after a dose using the medicine delivery device.

Abstract: A method for optional external calibration of a calibration-free glucose sensor uses values of measured working electrode current (Isig) and EIS data to calculate a final sensor glucose (SG) value. Counter electrode voltage (Vcntr) may also be used as an input. Raw Isig and Vcntr values may be preprocessed, and low-pass filtering, averaging, and/or feature generation may be applied. SG values may be generated using one or more models for predicting SG calculations. When an external blood glucose (BG) value is available, the BG value may also be used in calculating the SG values. A SG variance estimate may be calculated for each predicted SG value and modulated, with the modulated SG values then fused to generate a fused SG. A Kalman filter, as well as error detection logic, may be applied to the fused SG value to obtain a final SG, which is then displayed to the user.

Abstract: Methods, systems, and devices are disclosed for administering a medicament to a patient. In one aspect, a system includes an injection pen device in wireless communication with a mobile communication device. The injection pen device includes a housing including a chamber to encase a cartridge containing medicine, a dose setting and dispensing mechanism to set the mechanism to dispense a particular dose of the medicine from the loaded cartridge, a sensor unit to detect a dispensed dose based on positions and/or movements of the dose setting and dispensing mechanism, and an electronics unit in communication with the sensor unit to process the detected dispensed dose and time data associated with a dispensing event and to wirelessly transmit the dose data to a user's device. The mobile communication device provides a software application to provide the user with health information using the processed dose data.

Abstract: A continuous glucose monitoring system may utilize externally sourced information regarding the physiological state and ambient environment of its user for externally calibrating sensor glucose measurements. Externally sourced factory calibration information may be utilized, where the information is generated by comparing metrics obtained from the data used to generate the sensor's glucose sensing algorithm to similar data obtained from each batch of sensors to be used with the algorithm in the future. The output sensor glucose value of a glucose sensor may also be estimated by analytically optimizing input sensor signals to accurately correct for changes in sensitivity, run-in time, glucose current dips, and other variable sensor wear effects.

Abstract: Removable devices wearable on a user's skin and methods for using such devices are provided. An exemplary removable device includes a skin adhesive configured to adhere to the skin, a durable component, and an interface component interconnecting the durable component and the skin adhesive. The device separates at the interface component to remove the durable component from the skin adhesive upon application of a removal force to the device.

Abstract: A continuous glucose monitoring system may utilize externally sourced information regarding the physiological state and ambient environment of its user for externally calibrating sensor glucose measurements. Externally sourced factory calibration information may be utilized, where the information is generated by comparing metrics obtained from the data used to generate the sensor's glucose sensing algorithm to similar data obtained from each batch of sensors to be used with the algorithm in the future. The output sensor glucose value of a glucose sensor may also be estimated by analytically optimizing input sensor signals to accurately correct for changes in sensitivity, run-in time, glucose current dips, and other variable sensor wear effects.

Abstract: Systems, devices, and techniques are disclosed for administering and tracking medicine to patients and providing health management capabilities for patients and caregivers. In some aspects, a method includes receiving one or more analyte values associated with a health condition of the patient user; receiving contextual data associated with the patient user obtained by the mobile computing device, where the obtained contextual data includes information associated with a meal; determining a medicine metric value associated with an amount of medicine active in the body of the patient user; autonomously calculating a dose of the medicine without input from the user based at least on the one or more analyte values, the medicine metric value, and the information associated with a meal; and continuously displaying the calculated dose of the medicine.

Abstract: A glucose biosensor encasement includes a first membrane and a second membrane. The first membrane has a first interlocking segment. The second membrane has a second interlocking segment cooperating with the first interlocking segment of the first membrane to provide a cavity between the first membrane and the second membrane configured to receive a glucose sensor. At least one of the first membrane and the second membrane comprises a semi-permeable portion configured to regulate diffusion characteristics of glucose through the membrane to realize a sensitivity for a sensor in the cavity. A method is also provided.

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 diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters.

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: An insertion set system includes a base configured to be secured to a patient, and a flexible tubing on the base. The flexible tubing has a distal end portion forming a cannula to be inserted into the patient. An inserter having a needle is received by the base. The needle has a channel in which the distal end portion of the flexible tubing is received. The needle is able to slide relative to the flexible tubing, to selectively withdraw the needle off of the distal end portion of the flexible tubing. The base may include a passage for fluid flow arranged transverse to the axial dimension of the distal end portion of the flexible tubing.

Abstract: A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters.

Abstract: An embodiment of a sensor device includes a base substrate, a circuit pattern formed overlying the interior surface of the substrate, a physiological characteristic sensor element on the exterior surface of the substrate, conductive plug elements located in vias formed through the substrate, each conductive plug element having one end coupled to a sensor electrode, and having another end coupled to the circuit pattern, a multilayer component stack carried on the substrate and connected to the circuit pattern, the stack including features and components to provide processing and wireless communication functionality for sensor data obtained in association with operation of the sensor device, and an enclosure structure coupled to the substrate to enclose the interior surface of the substrate, the circuit pattern, and the stack.

Abstract: Provided is a system for delivering and recording a dose of a medicament to a patient. Also provided is a method of administering a medicament to a patient. Additionally provided is a method of tracking usage of a medicament by a patient through a pen.

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: Techniques disclosed herein relate to nutritional content determination based on gesture detection data. In some embodiments, the techniques involve obtaining gesture detection data corresponding to consumption of a food item or a drink; determining, based on the gesture detection data, nutritional content of the food item or the drink; and causing delivery of insulin in accordance with the nutritional content of the food item or the drink.

Abstract: This invention pertains to systems and components useful for infusing medications such as insulin. Typically, the components are used to deliver insulin to a diabetic patient at a site of infusion over a period of time greater than 4 days. The system components typically comprise a cannula adapted for subcutaneous insertion into a diabetic patient. The system further comprises a fluid conduit adapted to deliver the insulin solution from a medication reservoir to the site of infusion and a depot in operable contact with the fluid conduit. The depot comprises selected materials including a site-loss mitigating agent (such as heparin) which inhibits inflammation at the site of infusion, and encapsulation of the cannula at the site of infusion. The site-loss mitigating agent is not premixed with the insulin, and instead is adapted to contact the insulin solution in the depot as the insulin solution flows from the medication reservoir to the site of infusion.