Abstract: An adhesive patch for a drug delivery device with a bacteria impermeable sterility margin surrounding an edge surface of the adhesive patch is disclosed, as well as a drug delivery device fixed to such an adhesive patch and a method of assembling a drug delivery device with such an adhesive patch. In some arrangements, the sterility margin is attached to or integral with a lower liner on a lower surface of the adhesive patch. In other arrangements, the sterility margin is attached to or integral with an upper liner on an upper surface of the adhesive patch.

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: A cassette for a drug delivery device is described that includes a sleeve, a syringe having a barrel disposed in the sleeve, and a plunger-stopper slidably disposed within the barrel. The cassette further includes a spacer that is configured to be coupled to the sleeve. The cassette can form a part of an apparatus for injection of a therapeutic product along with a drug delivery 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: Syringes, assemblies for use in a filling process, and related methods of manufacture are disclosed. A syringe may include a reservoir filled or configured to be filled with a preselected volume of a drug, including, for example, a preselected volume of 3 mL or approximately 3 mL of the drug. The syringe may further include a wall comprising a cylindrical portion. The cylindrical portion of the wall may include: (a) an inner diameter equal to or approximately equal to a standard inner diameter of a 5 mL syringe or a standard outer diameter of any other syringe volume not equal to the preselected volume or 3 mL; and/or (b) an outer diameter equal to or approximately equal to a standard outer diameter of a 5 mL syringe or a standard outer diameter of any other syringe volume not equal to the preselected volume or 3 mL.

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: A testing assembly for a drug delivery device is disclosed. The testing assembly can include a pressure vessel having a sealed pressure chamber that is configured to be pressurized to a predetermined pressure. The pressure vessel further defines an injection opening extending from an exterior thereof to the pressure chamber. A pierceable barrier extends over and seals the injection opening. The testing assembly further includes a measurement device disposed within the pressure chamber and a container aligned with the injection opening, such that the container is configured to collect a dose of a drug delivered via a drug delivery device through the pierceable barrier and the measurement device is configured to measure the dose of the drug.

Abstract: An adhesive patch for a drug delivery device with a bacteria impermeable sterility margin surrounding an edge surface of the adhesive patch is disclosed, as well as a drug delivery device fixed to such an adhesive patch and a method of assembling a drug delivery device with such an adhesive patch. In some arrangements, the sterility margin is attached to or integral with a lower liner on a lower surface of the adhesive patch. In other arrangements, the sterility margin is attached to or integral with an upper liner on an upper surface of the adhesive patch.

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: An adhesive patch for a drug delivery device with a bacteria impermeable sterility margin surrounding an edge surface of the adhesive patch is disclosed, as well as a drug delivery device fixed to such an adhesive patch and a method of assembling a drug delivery device with such an adhesive patch. In some arrangements, the sterility margin is attached to or integral with a lower liner on a lower surface of the adhesive patch. In other arrangements, the sterility margin is attached to or integral with an upper liner on an upper surface of the adhesive patch.

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: 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: A testing assembly for a drug delivery device is disclosed. The testing assembly can include a pressure vessel having a sealed pressure chamber that is configured to be pressurized to a predetermined pressure. The pressure vessel further defines an injection opening extending from an exterior thereof to the pressure chamber. A pierceable barrier extends over and seals the injection opening. The testing assembly further includes a measurement device disposed within the pressure chamber and a container aligned with the injection opening, such that the container is configured to collect a dose of a drug delivered via a drug delivery device through the pierceable barrier and the measurement device is configured to measure the dose of the drug.

Abstract: An adhesive patch for a drug delivery device with a bacteria impermeable sterility margin surrounding an edge surface of the adhesive patch is disclosed, as well as a drug delivery device fixed to such an adhesive patch and a method of assembling a drug delivery device with such an adhesive patch. In some arrangements, the sterility margin is attached to or integral with a lower liner on a lower surface of the adhesive patch. In other arrangements, the sterility margin is attached to or integral with an upper liner on an upper surface of the adhesive patch.

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.