Abstract: A powering subassembly for a portable electronic device includes a main battery, a converter, a backup battery, and a controller. The main battery provides a main voltage and the backup battery can provide a backup voltage. The converter receives the main voltage and increases it to at least one operating voltage. The controller receives the operating voltage from the converter, monitors the voltage of the main battery, and compares the monitored voltage to a main battery low voltage threshold. The controller transmits a disconnect signal to decouple the main battery from the converter if the monitored voltage from the main battery is less than the main battery low voltage threshold. The controller transmits a connection signal to couple the backup battery to the converter if the monitored voltage is less than the main battery low voltage threshold. The backup battery provides the power for a predetermined minimum amount of time.

Abstract: The invention disclosed herein provides methods and materials for observing the state of a sensor, for example those used by diabetic patients to monitor blood glucose levels. Typically a voltage such as a voltage pulse is applied to the sensor in order to solicit a current response from which for example, factors such as impedance values can be derived. Such values can then be used as indicators of a sensor's state, for example the state of sensor hydration, sensor noise, sensor offset, sensor drift or the like.

Abstract: According to an embodiment of the invention, a method of determining hydration of a sensor having a plurality of electrodes is disclosed. In particular embodiments, the method couples a sensor electronics device to the sensor and measures the open circuit potential between at least two of the plurality of electrodes. Then, the open circuit potential measurement is compared to a predetermined value. In some embodiments, the plurality of electrodes includes a working electrode, a reference electrode, and a counter electrode. In still further embodiments, the open circuit potential between the working electrode and the reference electrode is measured. In other embodiments, the open circuit potential between the working electrode and the counter electrode is measured. In still other embodiments, the open circuit potential between the counter electrode and the reference electrode is measured.

Abstract: A system and method for providing closed loop infusion formulation delivery which accurately calculates a delivery amount based on a sensed biological state by adjusting an algorithm's programmable control parameters. The algorithm calculates a delivery amount having proportional, derivative, and basal rate components. The control parameters may be adjusted in real time to compensate for changes in a sensed biological state that may result from daily events. Safety limits on the delivery amount may be included in the algorithm. The algorithm may be executed by a computing element within a process controller for controlling closed loop infusion formulation delivery. The biological state is sensed by a sensing device which provides a signal to the controller. The controller calculates an infusion formulation delivery amount based on the signal and sends commands to an infusion formulation delivery device which delivers an amount of infusion formulation determined by the commands.

Abstract: A modular external infusion device that controls the rate a fluid is infused into an individual's body, which includes a first module and a second module. More particularly, the first module may be a pumping module that delivers a fluid, such as a medication, to a patient while the second module may be a programming module that allows a user to select pump flow commands. The second module is removably attachable to the first module.

Abstract: A delivery device includes a durable housing portion and a separable disposable portion that selectively engage and disengage from each other. The disposable housing portion secures to the patient-user and may be disposed of after it has been in use for a prescribed period. Components that normally come into contact with a patient-user or with infusion media are supported by the disposable housing portion for disposal after the prescribed use, while the durable housing portion supports other components such as electronics for controlling delivery of infusion media from the reservoir and a drive device and drive linkage.

Abstract: A method for formulating and immobilizing a protein and a protein matrix formed by the method. The protein matrix preparation method results in a physically and chemically stable protein matrix that has low swelling, non-leaching, high activity, and high mechanical strength properties. The method includes cross-linking and hardening the protein mixture and using a mold to form a protein into a desired shape and size.

Abstract: A sterile device immersed in a sterile buffer and a method for providing same. The sterile device may be a medical device such as a biosensor having a biomolecule as a sensing element such as, for example, a glucose oxidase enzyme. The buffer may be a bicarbonate solution. Both the device and the buffer may be packaged and stored over long term while maintaining sterilization. The sterilization method may comprise a combination of gaseous, liquid and light sterilization.

Abstract: A diabetes data management system selects variable threshold parameters that are utilized in a report. A first low threshold glucose reading and a first high threshold glucose reading for a before meal event timeframe are selected. A second low threshold glucose reading and a second high threshold glucose reading are selected for an after meal event timeframe. The threshold readings are stored in a database. The diabetes data management system analyzes glucose behavior around meal events. The system receives a plurality of glucose readings for a time period, receives a first time range as a pre-meal analysis period for the first meal event and receives a second time range as a post-meal analysis period for the first meal event. The system creates a graph which highlights the pre-meal analysis period, the post-meal analysis period, and displays the plurality of glucose readings for the time period.

Abstract: An insertion device, generally used with an infusion set, including a needle being adapted for puncturing at one end and including at the opposite end a hub. The hub includes a handle part and a guard part that are capable of securing the needle through the use of locks. Locking structures are used to secure the insertion device in a position where the needle is covered in a locked position, avoiding unintended contact with the needle.

Abstract: An infusion set is provided for use in delivering fluid through a cannula, which is housed on a cannula housing, to a selected subcutaneous infusion site on a patient. The fluid is generally a medication, e.g., insulin. The cannula is in fluid communication with a fluid passageway surrounded by a projection on the cannula housing that includes one or more rail-like extensions acting as guides. A connector connects the cannula housing to a fluid delivery system, e.g., an infusion pump. The connector includes a needle, one or more guide arms that slide over the rail-like extensions to guide the needle into the self-sealing septum, and one or more locking arms, with barbs at the end, to connect with corresponding recesses in the cannula housing. An introducer having one or more similar guide arms and locking arms, and a longer needle, may be used to insert the cannula into the patient.

Abstract: An insertion device, generally used with an infusion set, including a needle being adapted for puncturing at one end and including at the opposite end a hub. The hub includes a handle part and a guard part that are capable of securing the needle through the use of locks. Locking structures are used to secure the insertion device in a position where the needle is covered in a locked position, avoiding unintended contact with the needle.

Abstract: Embodiments of the invention provide a dual insertion set for supplying a fluid to the body of a patient and for monitoring a body characteristic of the patient. Typical embodiments of the invention include a base, an infusion portion coupled to a first piercing member and a sensor portion coupled to a second piercing member. The infusion portion includes a cannula coupled to the piercing member for supplying a fluid to a placement site. The sensor portion includes a sensor coupled to and extending from the base having at least one sensor electrode formed on a substrate and is coupled to the piercing member in a manner that allows the sensor to be inserted at the placement site. The base is arranged to secure the dual insertion set to the skin of a patient.

Abstract: Systems and methods for the delivery and monitoring of a medication, such as insulin, to a recipient are provided. An exemplary feature-rich system comprises an infusion pump with a control system for controlling medication delivery by the infusion pump and a bolus estimator for estimating an appropriate amount of medication for delivery by the control system with the infusion pump. Estimating the appropriate amount of medication for delivery is based upon one or more settings which each vary according to a setting profile. In other embodiments, the control system comprises a suspend function for temporarily suspending medication delivery by the infusion pump, an alarm profile function for programming a variable alarm volume of the alarm and a simplified menu for controlling the dual wave bolus delivery function.

Abstract: An improved pump, reservoir and reservoir piston are provided for controlled delivery of fluids. A motor is operably coupled to a drive member, such as a drive screw, which is adapted to advance a plunger slide in response to operation of the motor. The plunger slide is removably coupled to the piston. A method, system, and an article of manufacture for automatically detecting an occlusion in a medication infusion pump is provided. The electrical current to an infusion pump is measured. Based on a series of measurements of one or more variables, the infusion pump detects whether there is an occlusion in the system.

Abstract: Systems and methods for the delivery and monitoring of a medication, such as insulin, to a recipient are provided. An exemplary feature-rich system comprises an infusion pump with a control system for controlling medication delivery by the infusion pump and a bolus estimator for estimating an appropriate amount of medication for delivery by the control system with the infusion pump. Estimating the appropriate amount of medication for delivery is based upon one or more settings which each vary according to a setting profile. In other embodiments, the control system comprises a suspend function for temporarily suspending medication delivery by the infusion pump, an alarm profile function for programming a variable alarm volume of the alarm and a simplified menu for controlling the dual wave bolus delivery function.

Abstract: A method and system that enables a user to maintain a sensor in real time. The present invention involves performing a diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure to measure sensor impedance value in order to determine if the sensor is operating at an optimal level. If the sensor is not operating at an optimal level, the present invention may further involve performing a sensor remedial action. The sensor remedial action involves reversing the DC voltage being applied between the working electrode and the reference electrode. The reversed DC voltage may be coupled with an AC voltage to extend its reach.

Abstract: According to an embodiment of the invention, a method of determining hydration of a sensor having a plurality of electrodes is disclosed. In particular embodiments, the method couples a sensor electronics device to the sensor and measures the open circuit potential between at least two of the plurality of electrodes. Then, the open circuit potential measurement is compared to a predetermined value. In some embodiments, the plurality of electrodes includes a working electrode, a reference electrode, and a counter electrode. In still further embodiments, the open circuit potential between the working electrode and the reference electrode is measured. In other embodiments, the open circuit potential between the working electrode and the counter electrode is measured. In still other embodiments, the open circuit potential between the counter electrode and the reference electrode is measured.

Abstract: An insertion device, generally used with an infusion set, including a needle being adapted for puncturing at one end and including at the opposite end a hub. The hub includes a handle part and a guard part that are capable of securing the needle through the use of locks. Locking structures are used to secure the insertion device in a position where the needle is covered in a locked position, avoiding unintended contact with the needle.

Abstract: Systems and methods for the delivery and monitoring of a medication, such as insulin, to a recipient are provided. An exemplary feature-rich system comprises an infusion pump with a control system for controlling medication delivery by the infusion pump and a bolus estimator for estimating an appropriate amount of medication for delivery by the control system with the infusion pump. Estimating the appropriate amount of medication for delivery is based upon one or more settings which each vary according to a setting profile. In other embodiments, the control system comprises a suspend function for temporarily suspending medication delivery by the infusion pump, an alarm profile function for programming a variable alarm volume of the alarm and a simplified menu for controlling the dual wave bolus delivery function.