Abstract: Disclosed herein are various embodiments of clutching mechanisms applicable to a dual reservoir pumping mechanism for a drug delivery device, the clutching mechanisms serving to allow translation of one of the reservoirs during the filling process and thereafter connecting the reservoirs together such that one can be driven relative to the other one by means of a leadscrew or other driving mechanism.

Abstract: Disclosed herein is a double reservoir configuration for a pumping mechanism for a drug delivery device wherein one reservoir is rigidly fixed to a housing of the device and the other reservoir moves linearly translates with respect to the fixed reservoir. To avoid having either the input fluid port or the output fluid port moves as the second reservoir linearly translates, one port is in fluid communication with the fixed reservoir and a second fluid port is in communication with the moving reservoir via a hollow tube supporting a static plunger disposed within the moving reservoir. This arrangement provides for the added benefit of allowing air trapped within either of the reservoirs to be almost completely removed as the pump mechanism is filled with the fluid.

Abstract: A needle mechanism module for automatically inserting a fluid path into a patient for drug delivery is provided. The needle mechanism module can be a component of a wearable drug delivery device. The needle mechanism module can insert a needle and cannula into the patient responsive to activation of the drug delivery device by a user. After insertion, the needle can be automatically retracted, leaving only the cannula in the patient. As a result, discomfort of the user is reduced.

Abstract: Disclosed herein are various embodiments providing an expandable, flexible reservoir for use in a wearable drug delivery device. The reservoir comprises a flexible enclosure made with plastic film which incorporates pleats forming the side walls thereof to increase the volume efficiency and to avoid a “pillowing” effect when the reservoir is filled. The pleats may be formed at non-right angles with respect to each other such as to form a curved side walls for the reservoir. In variations of the invention, various methods are disclosed for maintaining a vacuum with the reservoir during its shelf life.

Abstract: Drive systems for a drug delivery device are provided. The drive systems can be positioned within a container that stores a liquid drug to be delivered to a user. The drive systems can be coupled to a plunger positioned within the container. The drive systems can be incrementally advanced to drive the plunger further into the container, thereby expelling a portion of the stored liquid drug from the container for delivery to the user. The container can be any type of container including a pre-filled, standardized drug cartridge. The drive systems and container can be components of a wearable drug delivery device.

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: Disclosed herein are structures for ensuring that the reservoir of drug delivery device is free from any residual air before the device is filled with a liquid drug and put into use. The structures described herein are designed to prevent air from entering the reservoir during the pendency of a shelf life of the drug delivery device and/or to remove any residual air that has entered the reservoir of the drug delivery device prior to it being filled with the liquid drug.

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: 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: 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 devices and methods for causing the linear translation of a plunger through a reservoir containing a fluid. A flexible member, for example, a wire or a ribbon, is coupled to the plunger and extends through a wall of the reservoir toward which the plunger is being linearly translated. A pulling force on the flexible member caused by a drive mechanism causes the plunger to linearly translate toward the end wall of the reservoir, thereby forcing any fluid contained in the reservoir out of the reservoir through a fluid port.

Abstract: Embodiments of the present disclosure relate to techniques, processes, devices or systems including a floating microneedle assembly decoupled from the device and protected by a pump housing. In one approach, a wearable drug delivery device may include a pump housing including a base attachable to a user, and a microneedle assembly coupled to a cannula. The microneedle assembly may be operable to deliver a liquid drug to the user, wherein the microneedle assembly comprises a carrier positioned proximate an opening of the base, and wherein the carrier comprises a plurality of microneedles operable to extend through the opening of the base to penetrate a skin of the user.

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: Embodiments of the present disclosure relate to techniques, processes, devices or systems for pump devices for providing a fixed volume of fluid, which is delivered and refilled within one pumping cycle. In one approach, a wearable drug delivery device may include a reservoir configured to store a liquid drug, and a drive mechanism coupled to the reservoir for receiving the liquid drug. The drive mechanism may include a housing defining a chamber, the housing including an inlet valve operable to receive the liquid drug and an outlet valve operable to expel the liquid drug from the chamber, and a resilient sealing member within the chamber. The drive mechanism may further include a shape memory wire coupled to the resilient sealing member, wherein the shape memory wire is operable to bias the resilient sealing member within the chamber.

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: Embodiments of the present disclosure relate to techniques, processes, devices or systems for automating fluid delivery without the use of an external interface device. In one approach, a wearable drug delivery device may include a reservoir configured to store a liquid drug, a pump mechanism coupled to the reservoir and operable to expel the liquid drug from the reservoir, and a mechanical triggering device engageable by a user. The mechanical triggering device is operable to change between a first configuration and a second configuration to control deployment of a needle to deliver the liquid drug into a patient.

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 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: Systems for piercing a septum of a drug delivery device is disclosed. The drug delivery device may include a needle conduit having an end and a drug container having a septum. The septum piercing mechanism may include a needle support operatively coupled to the needle conduit. The septum piercing mechanism may be movable from a first, unactivated configuration to a second, activated configuration. In the unactivated configuration, the septum seals an interior of the drug container from the end of the needle conduit. In the activated configuration, the end of the needle conduit pierces through the septum placing the needle conduit in fluid communication with the drug container. In one embodiment, activation may cause the needle support to move towards the drug container. In one embodiment, the needle support may be moved by a biasing member. Alternatively, in another embodiment, the needle support may be moved by a cam mechanism.