Abstract: A drug delivery device is provided that includes an on-board controller to determine when proper placement on the patient's body has occurred as well as an amount of drug delivered to the patient. The controller can also be used to determine if and when the proper placement has been disturbed during drug delivery and/or if less than a full dose of the drug has been dispensed.

Abstract: A drug delivery device includes a housing defining a shell comprising a front portion and a rear portion slidably coupled to the front portion, a drug delivery assembly at least partially disposed within the housing, at least one electronic component, a power source which powers the electronic component, and a switch assembly. The switch assembly is adapted to selectively cause the power source to provide power to the at least one electronic component.

Abstract: Systems and methods for injecting a drug and detecting tissue induced back pressure are disclosed. A drug delivery system may include a reservoir filled or fillable with a drug, an administration member connected or connectable in fluid communication with the reservoir, a drive assembly, and a pressure sensor. The administration member may be configured for insertion into and subsequently retraction from a patient. The drive assembly may be configured to urge the drug from the reservoir to deliver a dose of the drug to the patient via the administration member. The pressure sensor may be configured to detect tissue back pressure during use of the drug delivery system, including after dose completion and prior to retraction of the administration member. The drug delivery system may be controlled in a manner that accounts for the tissue back pressure measurement.

Abstract: Systems and methods for drug delivery with pressure sensitive control are disclosed. A drug delivery system may include a reservoir filled or fillable with a drug, a drug delivery device coupled to the reservoir to deliver the drug from the reservoir to a patient, a pressure sensor, an output device, and a controller. The controller may be configured to determine if the drug delivery device has completed delivering a dose of the drug to the patient, and if delivery of the dose of the drug is complete, to measure tissue back pressure using the pressure sensor. Subsequently, the controller may be configured to determine if the tissue back pressure is below a first predetermined value, and if so, control the output device at least once and/or control a mechanism to retract an administration member from the patient.

Abstract: An insertion/retraction mechanism for a drug delivery device is disclosed. The insertion/retraction mechanism includes a retraction hub, an insertion hub, an insertion/retraction mechanism housing, and a dual torsion spring system. The retraction hub includes a first primary rotational stop and a second primary rotational stop extending radially inwardly from an inside surface. The insertion hub is disposed inside the retraction hub and comprises a first complementary rotational stop and a second complementary rotational stop extending radially outwardly from an outside surface.

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: Systems and methods for delayed delivery of a drug are disclosed. A drug delivery system may include a delivery member for insertion into a patient and a reservoir configured to receive a volume of a drug. An energy source may be activatable by the patient to actuate the reservoir to deliver the drug to the patient as a single bolus. A lockout system may be configured to have a locked state, wherein the lockout system prevents movement of the delivery member and/or activation of the energy source, and an unlocked state, wherein the lockout system permits movement of the delivery member and/or activation of the energy source. The lockout system may be configured to automatically change from the locked state to the unlocked state after a preselected time period has elapsed. An output element may generate a detectable output after the preselected time period has elapsed for notifying the patient.

Abstract: A drug delivery device includes a housing defining a shell, a drug delivery assembly at least partially disposed within the housing, a cap defining an opening and being adapted to at least partially cover an end of the housing, at least one electronic component, a power source which powers the electronic component, and a switch assembly. The drug delivery assembly comprises a guard which engages an inner surface of the housing and is movable between a first, a second, and a third position relative to the housing and are adapted to restrict external contact with a cannula. The switch assembly causes the power source to provide power to the electronic component when the cap is removed from the housing, restrict the power source from providing power when the cap is coupled to the housing and the guard is in the first position, and cause the power source to provide power when the cap is coupled to the housing and the guard is in the third position.

Abstract: A drug delivery safety system includes a programmer with a display and a communications device adapted to communicate with an ambulatory medical device. The programmer has access to a database of information, and is adapted to receive and process the information and a user input and to control the display to provide a graphical user interface that prompts a user of the programmer to provide an additional user input when the user input requests a drug delivery protocol for the ambulatory medical device that is not already stored in the database as a clinician-approved drug delivery protocol.

Abstract: A drug delivery safety system includes a programmer with a display and a communications device adapted to communicate with an ambulatory medical device. The programmer has access to a database of information, and is adapted to receive and process the information and a user input and to control the display to provide a graphical user interface that prompts a user of the programmer to provide an additional user input when the user input requests a drug delivery protocol for the ambulatory medical device that is not already stored in the database as a clinician-approved drug delivery protocol.

Abstract: A drug delivery safety system includes a programmer with a display and a communications device adapted to communicate with an ambulatory medical device. The programmer has access to a database of information, and is adapted to receive and process the information and a user input and to control the display to provide a graphical user interface that prompts a user of the programmer to provide an additional user input when the user input requests a drug delivery protocol for the ambulatory medical device that is not already stored in the database as a clinician-approved drug delivery protocol.

Abstract: A drug delivery safety system includes a programmer with a display and a communications device adapted to communicate with an ambulatory medical device. The programmer has access to a database of information, and is adapted to receive and process the information and a user input and to control the display to provide a graphical user interface that prompts a user of the programmer to provide an additional user input when the user input requests a drug delivery protocol for the ambulatory medical device that is not already stored in the database as a clinician-approved drug delivery protocol.