Abstract: Systems and methods for monitoring an operational state and/or a fill status of a drug container of a drug delivery device are provided. The drug container can hold a liquid drug. A plunger can be positioned within the drug container. A drive system can advance the plunger to expel the liquid drug from the container. A monitoring system can detect a movement and/or a position of the plunger and/or any component coupled to the plunger. The detection can enable determination of an amount of liquid drug that has been expelled and/or an amount of liquid drug remaining in the drug container. Dosing rates, flow rates, and dosage completion can also be determined.

Abstract: Disclosed are a system, methods and computer-readable medium products that provide safety constraints for an insulin-delivery management program. Various examples provide safety constraints for a control algorithm-based drug delivery system that provides automatic delivery of a drug based on sensor input. Glucose measurement values may be received at regular time intervals from a sensor. A processor may predict future glucose values based on prior glucose measurement values. The safety constraints assist in safe operation of the drug delivery system during various operational scenarios. In some examples, predicted future glucose values may be used to implement safety constraints that mitigate under-delivery or over-delivery of the drug while not overly burdening the user of the drug delivery system and without sacrificing performance of the drug delivery system. Other safety constraints are also disclosed.

Abstract: Disclosed are a system, methods and computer-readable medium products that provide safety constraints for an insulin-delivery management program. Various examples provide safety constraints for a control algorithm-based drug delivery system that provides automatic delivery of a drug based on sensor input. Glucose measurement values may be received at regular time intervals from a sensor. A processor may predict future glucose values based on prior glucose measurement values. The safety constraints assist in safe operation of the drug delivery system during various operational scenarios. In some examples, predicted future glucose values may be used to implement safety constraints that mitigate under-delivery or over-delivery of the drug while not overly burdening the user of the drug delivery system and without sacrificing performance of the drug delivery system. Other safety constraints are also disclosed.

Abstract: A method of treating a host with a medication, comprising assigning a unique identifier to a host treatment apparatus; assigning a unique identifier to the host; storing the unique host identifier and the unique host treatment apparatus identifier on at least one remote server of a network and associating the unique host identifier and the unique host treatment apparatus identifier on the at least one remote server such that the unique host identifier and the unique host treatment apparatus identifier are exclusively associated to each other; activating the host treatment apparatus; coupling the host medication delivery device to the host; operating the host medication delivery device to deliver the medication contained in the host medication delivery device to the host; and operating the host treatment apparatus such that the host treatment apparatus communicates wirelessly to the at least one remote server an operational status of the host medication delivery device.

Abstract: Variable fill drug delivery devices for delivering a therapeutic agent to a patient are provided. A variable fill drug delivery device includes a drug container to store a variable amount (or user-selectable amount) of a therapeutic agent. A plunger of the variable fill drug delivery device is positioned in the drug container. An infusion engine of the variable fill device is coupled to the plunger. The infusion engine retains the plunger prior to activation of the variable fill drug delivery device and releases the plunger after activation of the variable fill drug delivery device. After activation, the infusion engine drives the plunger from a first position within the drug container to a second position within the drug container to expel the variable amount of the therapeutic agent from the drug container for delivery to a patient.

Abstract: A physiological parameter associated with tissue of a host may be monitored in the tissue to confirm subcutaneous delivery of medication to the host. More particularly, such may involve delivering medication subcutaneously to the host with a medical device which includes a sensor used to measure the physiological parameter, particularly within a predetermined time period after delivery of the medication. Such may also or otherwise involve forming a depot in the tissue with the medication, and using the sensor to measure the physiological parameter while the sensor is at least partially within the depot.

Abstract: An improved basal insulin management system and an improved user interface for use therewith are provided. User interfaces are provided that dynamically display basal rate information and corresponding time segment information for a basal insulin program in a graphical format. The graphical presentation of the basal insulin program as it is being built by a user and the graphical presentation of a completed basal insulin program provides insulin management information to the user in a more intuitive and useful format. User interfaces further enable a user to make temporary adjustments to a predefined basal insulin program with the adjustments presented graphically to improve the user's understanding of the changes. As a result of being provided with the user interfaces described herein, users are less likely to make mistakes and are more likely to adjust basal rates more frequently, thereby contributing to better blood glucose control and improved health outcomes.

Abstract: A fluid delivery device comprising a fluid reservoir; a transcutaneous access tool fluidly coupled to the fluid reservoir; and a drive mechanism for driving fluid from the reservoir, the drive mechanism comprising a plunger received in the reservoir; a leadscrew extending from the plunger; a nut threadably engaged with the leadscrew; a drive wheel; and a clutch mechanism coupled to the drive wheel, wherein the clutch mechanism is configured to allow the nut to pass through when disengaged and is configured to grip the nut when engaged such that the drive wheel rotates the nut to advance the drive rod and the plunger into the reservoir.

Abstract: Systems and methods for delivering a medication to a person experiencing an emergency medical event without requiring intervention or action on the part of the person. A device encases a reservoir of medication and a delivery mechanism. Sensors in the housing sense a physical attribute of the person and circuitry monitors information collected by the sensors to determine if the person is experiencing a severe medical condition or event based on the information. An input device on or in the housing, such as a button, may be used or activated by the person if the detected condition or event is a false positive to cancel further action. If the system does not include the button or if the user does not press it in time, the system activates the delivery device and injects the medication into the person.

Abstract: Various embodiments of the present invention include a cannula coated or compounded with a material to extend the wear time for a patient by reducing inflammation and therefore increasing the time that the cannula may remain inserted, thereby increasing the effectiveness of the drug delivered using the cannula. The material may include a hydrophilic material, an anti-microbial material, an anti-inflammatory material, anti-thrombogenic material, or a combination of any of these materials.

Abstract: Plunger systems for expelling a liquid drug from a drug container within a wearable drug delivery device are provided. A rotation system coupled to a plunger rotates the plunger about a central axis of the plunger to overcome a static friction between the plunger and the drug container. After rotating the plunger, a drive system moves the plunger forward into the drug container to expel the liquid drug for delivery to the patient. A collapsible plunger includes a cavity. A radial torsion spring positioned in the cavity can provide an outward radial force on the collapsible plunger. The cavity enables the collapsible plunger to compress radially when entering and passing through a region of a drug container having a relatively narrower width. The radial torsion spring can radially expand the collapsible plunger when entering and passing through a region of the drug container having a relatively wider width.

Abstract: A wearable drug delivery device that can deliver a liquid drug stored in a container to a patient is provided. The container can be a prefilled cartridge that can be loaded into the drug delivery device by the patient or that can be preloaded within the drug delivery device when provided to the patient. A sealed end of the container is pierced to couple the stored liquid drug to a needle conduit that is coupled to a needle insertion component that provides access to the patient. A drive system of the drug delivery device can expel the liquid drug from the cartridge to the patient through the needle conduit. The drive system can be controlled to provide the liquid drug to the patient in a single dose or over multiple doses.

Abstract: A wearable drug delivery device that can deliver a liquid drug stored in a container to a patient is provided. The container can be a prefilled cartridge that can be loaded into the drug delivery device by the patient or that can be preloaded within the drug delivery device when provided to the patient. A sealed end of the container is pierced to couple the stored liquid drug to a needle conduit that is coupled to a needle insertion component that provides access to the patient. A drive system of the drug delivery device can expel the liquid drug from the cartridge to the patient through the needle conduit. The drive system can be controlled to provide the liquid drug to the patient in a single dose or over multiple doses.

Abstract: The present disclosure relates generally to the field of drug delivery. In particular, the present disclosure relates to a drug delivery system that includes a sealed and sterile fluid path attached to a drug-loaded container. The disclosure further relates to methods for sterilizing a portion of the drug delivery system without exposing the drug-loaded container to harmful sterilization parameters.