Abstract: Disclosed are devices and methods for facilitating directed delivery of a medicament into a human organ of a patient. An apparatus to facilitate directed delivery of a medicament into a human organ of a patient may include a container configured to enclose the medicament, a needle having a passage therethrough and a sharp distalmost tip, and a needle guard at least partially surrounding a shaft of the needle. The needle guard may include a distal surface, wherein the sharp distalmost tip of the needle may be configured to extend through an opening in the distal surface. The needle guard may be moveable relative to the needle along an axis of the needle to control a distance from the distal surface to the distalmost tip of the needle.

Abstract: In one instance, disclosed herein is an auto-injector, the auto-injector including: a housing; a container disposed within the housing, the container configured to store a medicament; a canister disposed within the housing, the canister configured to release a pressurized medium to expel the medicament from the container; a shroud coupled to the housing, the shroud configured to move between a first position and a second position relative to the housing to cause the pressurized medium to be released by the canister; and a mandrel assembly disposed within the housing, the mandrel assembly configured to urge the shroud outward relative to the housing toward the first position after the pressurized medium is released by the canister.

Abstract: Systems and methods for determining Container Closure Integrity (CCI) in a container system comprising a container, an elastomeric stopper, and a retainer for retaining the stopper in place are disclosed. The systems and methods involve disposing, within a seal assembly, a component configured to sense a degree of compression of the elastomeric stopper. In a first implementation, the elastomeric stopper comprises an embedded positioning component embedded within the elastomeric material. The position of the positioning component is sensed using a detection system and the integrity of the closure is determined based on the position of the embedded component. In a second implementation, a force sensitive resistor is disposed within the seal stack to measure the compression of the elastomeric stopper. The compression of the elastomeric stopper is correlated to the integrity of the seal.

Abstract: A drug delivery device is disclosed, wherein the device comprises a housing; a product container arranged in the housing; a plunger rod partially disposed inside the product container; and a thumb pad configured to receive a portion of the plunger rod, wherein the thumb pad and the plunger rod are configured to transition from a first state to a second state, wherein at the first state, the plunger rod is prevented from moving in a proximal direction, and at the second state, the plunger rod moves freely in a proximal direction.

Abstract: A vial adapter assembly that includes a housing, a first receptacle formed within the housing and configured to receive a first vial within the housing, and a second receptacle formed within the housing and configured to receive a second vial within the housing. An opening of the first receptacle and an opening of the second receptacle is in fluid communication with the upper surface of the housing. The vial adapter assembly includes a cap that is coupled and movable relative to the housing from a closed configuration to an open configuration. In the closed configuration, the cap is configured to cover the opening of the first receptacle and the opening of the second receptacle on the upper surface. In the open configuration, the cap is configured to uncover the opening of the first receptacle and the opening of the second receptacle, and expose the upper surface.

Abstract: Systems and methods for determining Container Closure Integrity (CCI) in a container system comprising a container, an elastomeric stopper, and a retainer for retaining the stopper in place are disclosed. The systems and methods involve disposing, within a seal assembly, a component configured to sense a degree of compression of the elastomeric stopper. In a first implementation, the elastomeric stopper comprises an embedded positioning component embedded within the elastomeric material. The position of the positioning component is sensed using a detection system and the integrity of the closure is determined based on the position of the embedded component. In a second implementation, a force sensitive resistor is disposed within the seal stack to measure the compression of the elastomeric stopper. The compression of the elastomeric stopper is correlated to the integrity of the seal.