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: Reservoir systems with improved wake up and fill volume detection techniques are provided. An example reservoir system may include a flexible reservoir and electrical components for detecting fill volume of the flexible reservoir without adversely affecting performance of the flexible reservoir when receiving or dispensing a liquid drug.

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: 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: Disclosed herein is a method for execution by a drug delivery device for determining an optimal dose of a liquid drug for current cycle of a medication delivery algorithm, the method utilizing a stepwise evaluation of a model and a cost function across a coarse search space consisting of coarse discrete quantities of the drug and a refined search space consisting of refined discrete quantities of the drug.

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: Disclosed herein is a method for execution by a drug delivery device for determining an optimal dose of a liquid drug for current cycle of a medication delivery algorithm, the method utilizing a stepwise evaluation of a model and a cost function across a coarse search space consisting of coarse discrete quantities of the drug and a refined search space consisting of refined discrete quantities of the drug.

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: Disclosed herein are wearable drug delivery devices and methods for component positioning of a linear shuttle pump. In some approaches, a pump may include a pump chamber operably coupled with a piston, and a detent apparatus, wherein the detent apparatus comprises a detent body, a detent arm, and a detent engagement member. The detent engagement member may be retained in direct physical contact with first or second arrest locations of either the detent body or the detent arm. The pump may further include a piston grip coupled to the piston, the piston grip including a grip component engaged with an exterior of the piston. Movement of the piston grip may cause the piston to move axially relative to the pump chamber to control receipt and delivery of a liquid drug.

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: Disclosed herein are wearable drug delivery devices and methods for component positioning of a linear shuttle pump. In some approaches, a pump may include a pump chamber operably coupled with a piston, and a detent apparatus, wherein the detent apparatus comprises a detent body, a detent arm, and a detent engagement member. The detent engagement member may be retained in direct physical contact with first or second arrest locations of either the detent body or the detent arm. The pump may further include a piston grip coupled to the piston, the piston grip including a grip component engaged with an exterior of the piston. Movement of the piston grip may cause the piston to move axially relative to the pump chamber to control receipt and delivery of a liquid drug.

Abstract: Exemplary embodiments may address the problem of missing blood glucose concentration readings from a glucose monitor that transmits blood glucose concentration readings over a wireless connection due to problems with the wireless connection. In the exemplary embodiments, an automated insulin delivery (AID) device uses an estimate in place of a missing blood glucose concentration reading in determining a predicted future blood glucose concentration reading for a user. Thus, the AID device is able to operate normally in generating insulin delivery settings despite not receiving a current blood glucose concentration reading for a current cycle. There is no need to suspend delivery of insulin to the user due to the missing blood glucose concentration reading.

Abstract: Disclosed herein are approaches of forming a component, such as a valve, for a medical device. One approach includes providing a cylinder within a tube, the tube and the cylinder joined together in an interference fit, and annealing the tube and the cylinder, wherein the tube and the cylinder are no longer joined together in the interference fit following the annealing.

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: A low-force, non-displacement, micro/miniature valve and/or pump assembly is provided. A tube component having a first side port coupled to an inlet portion and a second side port coupled to an outlet portion can be selectively moved to alternatively couple the side ports to a first or second piston pump chamber. First and second pistons can be actuated after positioning the tube component to either draw in fluid or push out fluid from either the first or second piston pump chambers during each actuation of the pistons. The fluid can be drawn in from a reservoir and can be expelled to a patient for providing a dose of the fluid to the patient.

Abstract: A drug delivery system having a drug delivery device and an associated sensor is provided. The sensor can be associated with a sensing site on user. The drug delivery device can be positioned over the sensor in any rotational position and can be associated with an infusion site on the user. The close positioning of the sensor and the drug delivery device allows data from the sensor to be relayed to the drug delivery device and then on to a remote control device. Further, the drug delivery device can be replaced at the end of its duration of use, which is shorter than the duration of use of the sensor, without disturbing the sensor. Subsequent drug delivery devices can then be used with the sensor while allowing each corresponding infusion site to be changed, thereby providing more efficient operation of the drug delivery system.

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 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: 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.