Abstract: The present disclosure is directed to a dose setting mechanism that may be used with a drug delivery device. The dose setting mechanism may include an inner body having a helical thread along an outer cylindrical surface of the inner body, and a drive sleeve for driving a piston rod in an axial direction, the drive sleeve positioned within at least a portion of the inner body. The dose setting mechanism may further include a dose dial sleeve rotatably engaged with the helical thread of the inner body and a dial grip connected to the dose dial sleeve and releasably connected to the drive sleeve. Further when a dose is set, the dial grip is rotated so that both the dose dial sleeve and the drive sleeve rotate with respect to the inner body.

Abstract: A dispense interface for use with a drug delivery device. The dispense interface comprises a main outer body and an inner body. The inner body may be configured for connection to a drug delivery device and defines a first reservoir and a second reservoir. A first piercing needle is in fluid communication with the first reservoir and positioned for piercing a first cartridge of a drug delivery device. A second piercing needle is provided and in fluid communication with the second reservoir and positioned for piercing a second cartridge contained with a drug delivery device. A manifold is positioned adjacent the inner body and comprises a fluid groove arrangement. A valve arrangement is positioned between the inner body and the manifold and controls fluid communication of a first fluid contained in the first cartridge and a second fluid contained in the second cartridge by way of the fluid groove arrangement to a holding chamber.

Abstract: The present disclosure is directed to a dose setting mechanism that may be used with a drug delivery device. The dose setting mechanism may include an inner body having a helical thread along an outer cylindrical surface of the inner body, and a drive sleeve for driving a piston rod in an axial direction, the drive sleeve positioned within at least a portion of the inner body. The dose setting mechanism may further include a dose dial sleeve rotatably engaged with the helical thread of the inner body and a dial grip connected to the dose dial sleeve and releasably connected to the drive sleeve. Further when a dose is set, the dial grip is rotated so that both the dose dial sleeve and the drive sleeve rotate with respect to the inner body.

Abstract: A method and system for sequentially dispensing a non-user settable dose of one medicament followed by a user-settable dose of a primary medicament. A medicated module may be attachable to a drug delivery device and the drug delivery device may have a drug reservoir holding a first medicament. The medicated module includes a first needle, a second needle, a deformable membrane, and a second medicament. The deformable membrane facilitates sequential dosing of the second medicament followed by the first medicament. After the medicated module is attached to the drug delivery device, (i) the first needle is in fluid communication with the drug reservoir and (ii) the deformable membrane prevents fluid communication between the first and second needle. The deformable membrane prevents fluid communication between the first and second needle until substantially all of the second medicament is dispensed.

Abstract: A method and system for sequentially dispensing a non-user settable dose of one medicament followed by a user-settable dose of a primary medicament. The system may include a dual cross-section, floating piston arranged to facilitate first delivering all or substantially all of a given medicament (e.g., a secondary medicament) through an output needle and then thereafter delivering yet another medicament (e.g., a primary medicament) through the same output needle in a single injection step. The dual cross-section, floating piston of the system also reduces or limits ullage left in the medicated module relative to the amount of the secondary medicament dispensed from the system.

Abstract: A method and system for dispensing a non-user settable dose of one medicament and a user-settable dose of a primary medicament. The system may include a medicated module attachable to a drug delivery device, the drug delivery device having a drug reservoir holding a first medicament. The medicated module includes a first needle, a second needle, a collapsible feature holding a second medicament, a biasing feature operably connected to the collapsible feature, and a valve system having a closed position and an open position. During dispense, the valve system transitions from the closed position to the open position, and the biasing feature compresses the collapsible feature to force the second medicament to flow from the collapsible feature to the second needle.

Abstract: A medicated module attachable to a drug delivery device comprising a connecting body configured for attachment to the drug delivery device. A first needle held within a first needle hub of the connecting body and a second needle fixed within a second needle hub of the connecting body. A recess within the connecting body defining a reservoir. The reservoir containing at least one dose of a medicament and configured for fluid communication with the first needle. The connecting body further comprises a lockout feature that prevents the medicated module from being reconnected to the drug delivery device after the medicated module has been connected to the drug delivery device a first time.

Abstract: A system and method for priming a medicated module during attachment of the medicated module to a drug delivery device. The drug delivery device has a drug reservoir holding a first medicament. The medicated module includes an upper retention feature and a lower retention feature, wherein the upper retention feature is axially moveable relative to the lower retention feature. The medicated module also includes an engagement needle and an output needle, wherein the output needle is in fluid communication with the engagement needle. The module also includes a collapsible feature holding a second medicament, wherein the collapsible feature is operably connected to the upper retention feature. During attachment to the drug delivery device, (i) the upper retention feature moves axially relative to the lower retention feature, (ii) the collapsible feature collapses, and (iii) the engagement needle and the output needle are primed with the second medicament.

Abstract: A system to prevent leakage of a medicament in a medicated module is disclosed. The medicated module includes a medicated needle that holds a medicament. The medicated needle includes an engagement needle portion and an output needle portion in fluid communication with each other. The medicated module further includes a first seal and a second seal. A proximal end of the engagement needle portion partially pierces the first seal, and a distal end of the output needle portion partially pierces the second seal.

Abstract: A method and system for delivering a user-settable dose of a first medicament and a non-user settable dose of a second medicament through a single dose setter and a single dispense interface. The drug delivery system includes a drug delivery device and a medicated module. The drug delivery device comprises a single dose setter operably connected to a primary reservoir containing the first medicament. The medicated module comprises (i) a collapsible feature holding the second medicament and (ii) the single dispense interface having an output needle. Further, the drug delivery device and medicated module are each configured such that the single dose setter is mechanically linked to the collapsible feature after attachment of the medicated module to the drug delivery device.

Abstract: A medicated module attachable to a drug delivery device. The medicated module comprises a housing configured for attachment to a drug delivery device. The drug delivery device comprises a first medicament. A collapsible reservoir is contained within the housing. A pre-determined volume of a second medicament is contained within the reservoir. A needle arrangement is configured within the housing and the needle arrangement is arranged in fluid communication with the collapsible reservoir. A needle shroud may be configured, such that, during an injection step, the shroud acts on the reservoir to inject the second medicament.

Abstract: An electro-mechanical drug delivery device comprises a main body having a distal end and a proximal end. The distal end is configured to attach to a dispense interface. A separable housing that can prevent an administration of a drug by the drug delivery device, the housing configured to cover at least a portion of the distal end of the main body when the separable housing is coupled to the main body of the drug delivery device. A conduction element is provided by the main body and configured for establishing an electrical connection with an electrical connector. Establishment of the electrical connection is prevented when the housing does not cover at least a portion of the distal end of the main body. The electrical connection may be established when the housing covers at least a portion of the distal end of the main body of the drug delivery device.

Abstract: A medicated module for an injection system to co-deliver at least two medicaments is disclosed where a primary delivery device containing a primary medicament accepts a medicated module containing a single dose of a secondary medicament and where both medicaments are delivered through a hollow needle. The medicated module is user selectable so that it will deliver a priming dose of a primary medicament or both the primary and secondary medicaments. The module also contains a needle guard that locks after dose delivery. The needle guard prevents accidental needle sticks before and after an injection. A locking collar rotates during use as an inner protrusion follows three paths of a track located on the outer surface of a body housing. When the inner facing protrusion is in the third path, it encounters a hard stop and a rotational bias that locks the guard from further refraction and thus covers the sharp distal end of the needle.

Abstract: A computerized electro-mechanical drug delivery device configured to deliver at least one dose of two or more medicaments. The device comprises a control unit. An electro-mechanical drive unit is operably coupled to the control unit and a primary reservoir for a first medicament and a secondary reservoir for a fluid agent, e.g. a second medicament. An operator interface is in communication with the control unit. A single dispense assembly is configured for fluid communication with the primary and the secondary reservoir. Activation of the operator panel sets a first dose from the primary reservoir and based on the first dose and a therapeutic dose profile, the control unit is configured to determine a dose or range of the fluid agent. Alternatively, the control unit determines or calculates a dose or range of a third medicament. Further, a dispense interface for use with a drug delivery device is disclosed.

Abstract: A medicated module attachable to a drug delivery device comprises a connecting body configured for attachment to the drug delivery device. A first needle is fixed within the connecting body and a movable needle hub is operatively coupled to the connecting body. A needle guard is operatively coupled to the connecting body and a biasing member is positioned between the connecting body and needle guard. A second needle is fixed within the needle hub. A first cavity within the connecting body defines a reservoir containing at least one dose of a medicament. The reservoir configured for fluid communication with the first and the second needle. The reservoir comprises a bypass configured to allow medicament from the drug delivery device to bypass the reservoir and exit the second needle.

Abstract: A medicated module for an injection system to co-deliver at least two medicaments is disclosed where a primary delivery device containing a primary medicament accepts a medicated module containing a single dose of a secondary medicament contained within a capsule having an integral flow distributor/distribution system and where both medicaments are delivered through a single hollow needle.

Abstract: The present disclosure is directed to a dose setting mechanism that may be used with a drug delivery device. The dose setting mechanism may include an inner body having a helical thread along an outer cylindrical surface of the inner body, and a drive sleeve for driving a piston rod in an axial direction, the drive sleeve positioned within at least a portion of the inner body. The dose setting mechanism may further include a dose dial sleeve rotatably engaged with the helical thread of the inner body and a dial grip connected to the dose dial sleeve and releasably connected to the drive sleeve. Further when a dose is set, the dial grip is rotated so that both the dose dial sleeve and the drive sleeve rotate with respect to the inner body.

Abstract: A medicated module (4) for an injection system to co-deliver at least two medicaments is disclosed where a primary delivery device containing a primary medicament accepts a medicated module (4) containing a single dose of a secondary medicament (2) and where both medicaments are delivered through a single hollow needle (5). The medicated module (4) is user selectable so that it will deliver both the primary (1) and secondary medicaments (2), or only the primary medicament (1). The module (4) also contains a guard (42) that locks after dose delivery.

Abstract: A medicated module (4) for an injection system to co-deliver at least two medicaments (1, 2) is disclosed where a primary delivery device (7) containing a primary medicament (1) accepts a medicated module (4) containing a single dose of a secondary medicament (2) and where both medicaments (1, 2) are delivered through a single hollow needle (3, 16, 21, 31).

Abstract: A medicated module comprising a connecting body configured for attachment to a drug delivery device. A first needle is fixed within the connecting body and an outer body operatively coupled to the connecting body. A needle guard operatively coupled to the outer body and a biasing member positioned between the outer body and needle guard. A second needle fixed within the outer body and a recess within the connecting body defines a reservoir. The reservoir contains at least one dose of a medicament and is configured for fluid communication with the first and second needle.