Abstract: Fluid path assemblies for drug delivery devices and methods of establishing a fluid flow path for drug delivery devices are described that include a needle shield valve member that couples to a reservoir having a needle mounted thereto. The needle shield valve member includes an internal barrier that protects the needle and/or contains a drug within the reservoir until activation of the drug delivery device. Upon activation, there is relative movement between the reservoir and needle shield valve member until the needle pierces the barrier to establish a fluid flow path from the reservoir through the needle shield valve member.

Abstract: Fill-finish assemblies facilitating the manufacture of a drug delivery device are disclosed. The fill-finish assembly may include a container, an insertion mechanism, a fluid pathway connection assembly disposed between the container and the insertion mechanism, and a carrier. The insertion mechanism may include a delivery member and an insertion mechanism housing. The insertion mechanism may be configured to move the delivery member from a retracted position inside the insertion mechanism housing to a deployed position outside the insertion mechanism housing. The fluid pathway connection assembly may be selectively activatable to establish fluid communication between the container and the delivery member. The carrier may have a hollow interior containing at least a portion of each of the container, the insertion mechanism, and the fluid pathway connection assembly.

Abstract: Drug delivery devices are described that include an escapement activation assembly. The escapement activation assembly includes a slide having a plurality of pallet engagement portions and a switch engagement portion and a pallet having a plurality of slide engagement portions. A drive is coupled to the pallet to cause the pallet to move relative to the slide to move the plurality of slide engagement portions into and out of engagement with the plurality of pallet engagement portions to allow the slide to move along a path within the drug delivery device. Movement of the slide can cause the switch engagement portion to move out of engagement with an activation trigger of a mechanism of the drug delivery device.

Abstract: A flexible plunger rod, drug delivery mechanism, drug delivery device, and methods are described that utilize the flexible plunger rod perform drug delivery operations. In embodiments, the flexible plunger rod can be stored in a curved configuration to thereby reduce a footprint of the drug delivery mechanism and device.

Abstract: Drug delivery devices and related methods of assembly are disclosed. The drug delivery device may include a main housing having an interior surface defining an enclosed space, and an exterior surface releasably attachable to a patient. A container may be disposed in the enclosed space and include a reservoir containing a drug and a stopper. A drive assembly may also be disposed in the enclosed space and configured to move the stopper through the reservoir to expel the drug from the reservoir. The drive assembly may include a rotational power source and a gear module. The gear module may include a mounting plate and a plurality of gears rotatably connected to the mounting plate. Furthermore, the mounting plate may be separate from the main housing.

Abstract: Drug delivery devices and related methods of assembly are disclosed. The drug delivery device may include a main housing having an interior surface defining an enclosed space, and an exterior surface releasably attachable to a patient. A container may be disposed in the enclosed space and include a reservoir containing a drug and a stopper. A drive assembly may also be disposed in the enclosed space and configured to move the stopper through the reservoir to expel the drug from the reservoir. The drive assembly may include a rotational power source and a gear module. The gear module may include a mounting plate and a plurality of gears rotatably connected to the mounting plate. Furthermore, the mounting plate may be separate from the main housing.

Abstract: Drug delivery devices and related methods of assembly are disclosed. The drug delivery device may include a main housing having an exterior surface releasably attachable to a patient, a container disposed in an enclosed space defined by an interior surface of the main housing, and a drive assembly. The container may include a reservoir containing a drug and a stopper. The drive assembly may include drive housing and a tether which slidably engages and is pulled taut against a guide surface of the drive housing. A first end of the tether may be wound around a capstan which is mounted rotatably relative to the drive housing. A second end of the tether may be operably connected to a stopper biasing member. The tether may initially retain the stopper biasing member in an energized state. When released, the stopper biasing member may expand to move the stopper through the reservoir.

Abstract: Modular fluid path assemblies are provided that include conduit, coupling, and needle portions of a fluid path fluidly coupled to an outlet of a container. The modular fluid path assemblies further include a needle shield having a tip of the needle embedded therein. So configured, in embodiments, the modular fluid path assemblies can be sterilized, a medicament can be filled in the container, and a stopper inserted in the container so that the pre-sterilized and pre-filled modular fluid path assemblies can have a closed container integrity (CCI) seal.

Abstract: An insertion mechanism for a wearable drug delivery device includes a needle hub, a needle coupled to the needle hub, a flexible boot removably coupled to the needle hub, and a cannula coupled to the flexible boot. The needle hub, the needle, the flexible boot, and the cannula are movable between a first position and a second position. Upon moving the needle hub, the needle, the flexible boot, and the cannula from the first position to the second position, the cannula engages a floor member to restrict movement of the cannula and the flexible movement towards the first position.

Abstract: Modular fluid path assemblies are provided that include conduit, coupling, and needle portions of a fluid path fluidly coupled to an outlet of a container. The modular fluid path assemblies further include a needle shield having a tip of the needle embedded therein. So configured, in embodiments, the modular fluid path assemblies can be sterilized, a medicament can be filled in the container, and a stopper inserted in the container so that the pre-sterilized and pre-filled modular fluid path assemblies can have a closed container integrity (CCI) seal.

Abstract: Drug delivery devices are described that include an escapement activation assembly. The escapement activation assembly includes a slide having a plurality of pallet engagement portions and a switch engagement portion and a pallet having a plurality of slide engagement portions. A drive is coupled to the pallet to cause the pallet to move relative to the slide to move the plurality of slide engagement portions into and out of engagement with the plurality of pallet engagement portions to allow the slide to move along a path within the drug delivery device. Movement of the slide can cause the switch engagement portion to move out of engagement with an activation trigger of a mechanism of the drug delivery device.

Abstract: Fluid path assemblies for drug delivery devices and methods of establishing a fluid flow path for drug delivery devices are described that include a needle shield valve member that couples to a reservoir having a needle mounted thereto. The needle shield valve member includes an internal barrier that protects the needle and/or contains a drug within the reservoir until activation of the drug delivery device. Upon activation, there is relative movement between the reservoir and needle shield valve member until the needle pierces the barrier to establish a fluid flow path from the reservoir through the needle shield valve member.

Abstract: Drug delivery devices and related methods of assembly are disclosed. The drug delivery device may include a main housing having an interior surface defining an enclosed space, and an exterior surface releasably attachable to a patient. A container may be disposed in the enclosed space and include a reservoir containing a drug and a stopper. A drive assembly may also be disposed in the enclosed space and configured to move the stopper through the reservoir to expel the drug from the reservoir. The drive assembly may include a rotational power source and a gear module. The gear module may include a mounting plate and a plurality of gears rotatably connected to the mounting plate. Furthermore, the mounting plate may be separate from the main housing.

Abstract: A flexible plunger rod, drug delivery mechanism, drug delivery device, and methods are described that utilize the flexible plunger rod perform drug delivery operations. In embodiments, the flexible plunger rod can be stored in a curved configuration to thereby reduce a footprint of the drug delivery mechanism and device.

Abstract: Fill-finish assemblies facilitating the manufacture of a drug delivery device are disclosed. The fill-finish assembly may include a container, an insertion mechanism, a fluid pathway connection assembly disposed between the container and the insertion mechanism, and a carrier. The insertion mechanism may include a delivery member and an insertion mechanism housing. The insertion mechanism may be configured to move the delivery member from a retracted position inside the insertion mechanism housing to a deployed position outside the insertion mechanism housing. The fluid pathway connection assembly may be selectively activatable to establish fluid communication between the container and the delivery member. The carrier may have a hollow interior containing at least a portion of each of the container, the insertion mechanism, and the fluid pathway connection assembly.

Abstract: Drug delivery devices and related methods of assembly are disclosed. The drug delivery device may include a main housing having an exterior surface releasably attachable to a patient, a container disposed in an enclosed space defined by an interior surface of the main housing, and a drive assembly. The container may include a reservoir containing a drug and a stopper. The drive assembly may include drive housing and a tether which slidably engages and is pulled taut against a guide surface of the drive housing. A first end of the tether may be wound around a capstan which is mounted rotatably relative to the drive housing. A second end of the tether may be operably connected to a stopper biasing member. The tether may initially retain the stopper biasing member in an energized state. When released, the stopper biasing member may expand to move the stopper through the reservoir.

Abstract: Modular fluid path assemblies are provided that include conduit, coupling, and needle portions of a fluid path fluidly coupled to an outlet of a container. The modular fluid path assemblies further include a needle shield having a tip of the needle embedded therein. So configured, in embodiments, the modular fluid path assemblies can be sterilized, a medicament can be filled in the container, and a stopper inserted in the container so that the pre-sterilized and pre-filled modular fluid path assemblies can have a closed container integrity (CCI) seal.

Abstract: An insertion mechanism for a wearable drug delivery device includes a needle hub, a needle coupled to the needle hub, a flexible boot removably coupled to the needle hub, and a cannula coupled to the flexible boot. The needle hub, the needle, the flexible boot, and the cannula are movable between a first position and a second position. Upon moving the needle hub, the needle, the flexible boot, and the cannula from the first position to the second position, the cannula engages a floor member to restrict movement of the cannula and the flexible movement towards the first position.