Abstract: A plunger assembly is configured for slidable advancement through a reservoir of a vessel containing a material to be administered. The plunger assembly includes a plunger rod having a distal end configured to be inserted into the reservoir. An elastomeric plunger extending from the distal end of the plunger rod is configured to sealingly engage a sidewall of the reservoir. At least one printed circuit board is embedded within the plunger, and at least one electronic component is electrically connected with the at least one printed circuit board.

Abstract: A method for manufacturing at least one elastomeric article is provided. The method includes placing into a mold an assembly of an uncured elastomeric sheet, a first film fully covering the elastomeric sheet and a second film covering the first film, such that the second film is in contact with and positioned between the first film and an interior surface of the mold. The method further includes curing the assembly in the mold, such that the first film is laminated onto the elastomeric sheet thereby forming the at least one elastomeric article.

Abstract: A system for testing the closure integrity of a sealed container at a cryogenic temperature is provided. The system includes a sealed container containing helium having an opening sealed by a closure, a cryogenic storage vessel at least partially filled with a cryogenic fluid at the cryogenic temperature, a hollow tube extending through an opening of the cryogenic storage vessel, a fixture configured to engage the sealed container, and a leak detection unit connected to the hollow tube. The hollow tube has a first end positioned outside of the cryogenic storage vessel and an opposing second end positioned inside the cryogenic storage vessel. The fixture is configured to be removably inserted within the hollow tube through an opening at the first end of the hollow tube, such that the sealed container is positioned at or proximate the second end of the hollow tube.

Abstract: A medical component is provided which includes a first portion formed of a first elastomeric material having at least one taggant embedded or incorporated therein, and a second portion formed of a second elastomeric material. The at least one taggant has a first diffusivity relative to the first elastomeric material and a second diffusivity relative to the second elastomeric material. The second diffusivity is less than the first diffusivity.

Abstract: A compliance monitoring system is provided for an injection device having an unused state and a used state. The system includes one or more radio frequency tags attached to a surface of the injection device and a portable monitoring accessory that includes a housing, a radio frequency antenna disposed within the housing, a wireless transmitter module disposed within the housing, and a processing circuit disposed within the housing. The processing circuit is configured to receive, via the radio frequency antenna, a first signal from the one or more radio frequency tags via a radio frequency communication protocol. The processing circuit is also configured to transmit, via the wireless transmitter, a second signal to a mobile device via a wireless communication protocol different from the radio frequency communication protocol. Both of the first signal and the second signal include state information of the injection device.

Abstract: A packaging system for aseptically packaging, filling, and sealing medical containers includes a container tray (100) having a container cell (120) for receiving and stabilizing the medicine container. The system also includes a stopper holder (300) with a stopper cell (320) forming a closed body with a distal opening, an interior space, a proximal wall opposite the distal opening, and a proximal outer surface (330). The stopper cell (320) is configured for releasably securing the stopper and releasing the stopper into a fill opening of the medicine container when a compressive force is exerted on the proximal outer surface of the stopper cell (320).

Abstract: Methods and systems for measuring a component of a drug delivery or storage device are described. The method comprises providing a light source in an opposing relationship with an optical imaging sensor; positioning a sample component on a positioning stage located between the at least one light source and at least one opposing optical imaging sensor; and illuminating, with the at least one light source, the sample component. The controller is operable to capture an image of the component, determine the location of a first outer edge point PI of the captured image; rotate the sample component relative to the optical image sensor, and collect n images separated from each other by x degrees of rotation, wherein n*x is ?360 degrees. The controller may compare a measured position of the at least one outer edge point PI between the captured images to determine a degree or circular runout.

Abstract: A needle safety device has an outer tube within which a syringe barrel from which a cannula extends is slideably receivable. A collar in the outer tube is moveable relative thereto and rotatably attachable to the distal end of the barrel. A force member biases the outer tube in a distal direction. A cannula shield able to receive the cannula therein is in the outer tube. The cannula shield is fixedly attached to a cap removably attached to the outer tube. A track is formed in the inner surface of the outer tube. A pin extending radially outwardly from the collar slidingly engages the track. In a pre-injection position, the cannula is entirely within the outer tube. In a full-insertion position, the cannula extends beyond the outer tube. In a locked position, the cannula is irreversibly retained entirely within the outer tube.

Abstract: A syringe nest assembly includes a base having a first surface and an opposing second surface and a first plate movably coupled to the base. The base includes a plurality of nesting units extending upwardly away from the first surface of the base. Each nesting unit includes a hollow body having a first open end distal from the first surface of the base and an opposing second open end. The first plate has a first surface and an opposing second surface. The first plate includes a plurality of apertures extending from the first surface to the second surface of the first plate. Each aperture of the first plate is generally aligned with a respective nesting unit of the base.

Abstract: A barrel is provided having open proximal end and a closed distal end, and at least one groove in an interior wall thereof. The groove(s) define a length extending a distance from the open end of the barrel toward the distal end of the barrel and defining a substantially constant depth and width along the length thereof. A piston is in sealing engagement with the interior wall of the barrel. The groove(s) permits fluid to bypass the piston when positioned along the groove(s). At least a portion of the piston is positioned distally from the groove(s), thereby sealing substance within the barrel.

Abstract: An apparatus for presenting an application status of a medical device that has a unused state and a used state. The apparatus includes a label having an electrochromic element. The label is at least partially disposed on an exterior surface of the medical device and is configured to display a predetermined feature in response to an electric current. A power source is disposed in or on the medical device for providing the electric current. A switch is configured to selectively connect or disconnect the label and the power source to one another for controlling the application of the electric current to the electrochromic element in response to actuation of the medical device from the unused state to the used state. The label may be scanned by a scan device that may connect to a medical organization for communicating information between the scan device and the medical organization.

Abstract: A syringe system, including a plunger, a microcontroller, a battery, and a coil. The syringe barrel having a proximal end, a distal end, and a cylindrical sidewall defining a longitudinal axis, the cylindrical sidewall extending longitudinally between the proximal and distal ends, the sidewall having an exterior surface and defining an internal volume, the plunger being positioned between the proximal and distal ends of the syringe barrel and being movable within the internal volume with respect to the syringe barrel in the longitudinal direction. The syringe barrel further includes a label disposed on the sidewall and having at least two conductive strips extending in a non-parallel direction with respect to the longitudinal axis and having unique lengths. The microcontroller is configured to determine a position of the plunger with respect to the syringe barrel by measuring a current induced in the coil by the at least two conductive strips.

Abstract: A needle safety system for a syringe having a generally cylindrical barrel extending along a longitudinal axis, the barrel having a hub from which a needle extends distally. The needle safety device has a sleeve at least partially enclosing the needle. A guide track is formed in the sleeve. A multi-part collar disposed in the sleeve has an inner collar which is fixedly connectable to the hub of a syringe barrel. An outer collar is rotatably attached to the inner collar. A guide pin extending radially outwardly from the outer collar slideably engages the guide track. A torqueable compression spring extending between the outer collar and the sleeve biases the sleeve in a distal direction and also biases the outer collar in rotation relative to the sleeve.

Abstract: An injection system, including an injector having a dispensing mechanism configured to dispense a medicament, and a ready-to-use indicator. The ready-to-use indicator includes a controller configured to interact with the ready-to-use indicator and an audio and/or visual indicator, a temperature sensor, and a temperature analog having similar thermodynamic properties of the medicament. The temperature sensor is configured to detect a temperature of the temperature analog which represents the dynamic temperature of medicament as the medicament is heated or cooled. The temperature sensor is configured to communicate the detected temperature to the controller and to alert the controller when a preset temperature is reached. The ready-to-use indicator is configured to alert a user when the preset temperature is reached, signifying the medicament is thermally ready to be delivered by the dispensing mechanism. The audio and/or visual indicator is configured to display indicate one or more notifications to the user.