Abstract: A medical device comprising an infusion device comprising a fluid reservoir to contain a therapeutic fluid and a transcutaneous access tool fluidly coupled to the fluid reservoir, the transcutaneous access tool configured to deliver the therapeutic fluid subcutaneously to a patient; wherein the infusion device operates in a stand-by mode prior to the therapeutic fluid being introduced into the fluid reservoir; wherein the infusion device operates to deploy the transcutaneous access tool within a predetermined deployment time period upon filling the fluid reservoir to a predetermined fill level with the therapeutic fluid.

Abstract: A system for sterilizing a drug delivery device includes a drug delivery device having a first self-healing seal configured to seal a fluid reservoir disposed within the drug delivery device. A sealable container is configured to receive the drug delivery device therein. The sealable container has a base portion and a cover portion. The cover portion has a second self-healing seal positioned to align with the first self-healing seal when the drug delivery device is disposed within the sealable container. A fill port includes a fill path, the fill path being configured to pass through the first and second self-healing seals to fluidly couple the fill port to the reservoir of the drug delivery device. Other systems, methods, and devices of sterilization are also disclosed.

Abstract: Systems and methods for automatically delivering medication to a user. A sensor coupled to a user can collect information regarding the user. A controller can use the collected information to determine an amount of medication to provide the user. The controller can instruct a drug delivery device to dispense the medication to the user. The drug delivery device can be a wearable insulin pump that is directly coupled to the user. The controller can be part of or implemented in a cellphone. A user can be required to provide a confirmation input to allow a determined amount of insulin to be provided to the user based on detected glucose levels of the user. The sensor, controller, and drug delivery device can communicate wirelessly.

Abstract: A wearable drug delivery device that can deliver high volumes of liquid drugs stored in one or more corresponding containers to a patient is provided. The wearable drug delivery device can include first and second containers to store first and second liquid drugs, respectively. A first set of energy transfer spheres can be coupled to a first spring and a first plunger positioned within the first container. A second set of energy transfer spheres can be coupled to a second spring and a second plunger positioned within the second container. The first spring can expand to advance the first set of energy transfer spheres and the first plunger to expel the first liquid drug for delivery to the patient. The second spring can expand to advance the second set of energy transfer spheres and the second plunger to expel the second liquid drug for delivery to the patient.

Abstract: A medical device to test bodily fluid, the device comprising a light emitting source, the light emitting source arranged to emit light inside the medical device; a test strip port, the test strip port comprising a test strip port receptacle to receive a test strip; and the light emitting source and the test strip port arranged such that, when the light emitting source emits light, at least a portion of the light emitted from the light emitting source is redirected inside the medical device to provide redirected light inside the medical device, and at least a portion of the redirected light lights the test strip port from inside the medical device in a manner than the redirected light is visible outside the test strip port.

Abstract: A multiple pulse volume shuttle pump powered by a shape memory alloy (SMA) wire is disclosed. In some embodiments, a shuttle pump system may include a pump chamber, a valve operable with the pump chamber, and a wire coupled to a valve shaft of the valve for controlling a position of the valve. The shuttle pump system may further include a pin disposed within an inset pathway of a cam, wherein the pin is moveable between multiple positions of the inset pathway in response to actuation of the valve shaft.

Abstract: Systems, components, and methods are disclosed for withdrawing drug from a liquid drug container and transferring drug to a medical device. One or more components may have keying features so that only the correct liquid drug container and medical device are accessed, making sure the medical device is filled with the correct drug. A syringe needle hub may have keying features corresponding to keying features on a cap on the liquid drug container and on the medical device. An alignment device facilitates easy-to-operate filling of a medical device. The alignment device aligns a liquid drug container over a fill port of the medical device and can include components for moving the liquid drug container into engagement with the medical device and for automatically initiating drug transfer to the medical device. A retractable skirt or needle cover protects the needle and is unlocked only when the skirt or needle cover is close to or touching the medical device.

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: Drug delivery systems with reduced hold-up volumes are provided. The drug delivery systems include a cartridge configured to hold a liquid drug. A cartridge stopper is positioned in a first portion of the cartridge. A needle guide component is positioned within the cartridge stopper. A needle is positioned within a central opening of the needle guide. A plunger is positioned in a second portion of the cartridge. The plunger includes a fluid path pocket facing and aligned with the central opening of the needle guide component. The plunger is driven toward the cartridge stopper to expel the liquid drug from the cartridge through the needle. An end of the needle can be positioned within the fluid path pocket when the plunger is pushed against the cartridge stopper, ensuring that only a small volume of the liquid drug remains in the cartridge when delivery of the liquid drug is completed.

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.

Abstract: A fluid delivery device comprising a fluid reservoir; a transcutaneous access tool fluidly coupled to the fluid reservoir, the transcutaneous access tool including a needle or a trocar; and a transcutaneous access tool insertion mechanism for deploying the transcutaneous access tool, wherein the insertion mechanism is configured to insert and retract the needle/trocar in a single, uninterrupted motion.

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: Examples of fluid delivery drive system and/or pump system that creates a vacuum in a fluid line for drawing and expelling fluid are provided. The vacuum may be created by separating two components that are positioned within the sealed fluid line. Once the two components are separated and the fluid is contained within the volume created between the separated components, the two components may be shuttled within the sealed volume. The movement of the two components can seal off an inlet to the fluid line and then open a pathway to an outlet from the fluid line while ensuring the created volume between the two components is maintained constant. The two components can then be moved back together to expel the fluid from the created volume through the outlet for delivery, for example, to a patient. Other examples are disclosed and described.

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.