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, in the form of an injector, may include one of a number of systems for limiting the delivery of a medical fluid or drug product in case of movement of (e.g., removal of) the injector relative to the patient as determined by a proximity sensor. The drug delivery system may in the alternative or in addition include systems for indicating the amount of medical fluid or drug product delivered (or not delivered) in case of movement of (e.g., removal of) the injector relative to the patient as determined by the proximity sensor. The injector may be, for example, an on-body injector or an hand-held autoinjector.

Abstract: An injector includes a housing having a syringe assembly and an actuating mechanism at least partially disposed within the housing. The syringe assembly includes a syringe barrel that stores a medicament to be injected into a user, a needle assembly, and a filter member disposed adjacent to the needle assembly. The actuating mechanism is operatively coupled to the syringe assembly and includes a torque spring that exerts a torque to urge the medicament through the filter member to be injected into the user. The actuating mechanism further includes a damper mechanism that exerts an opposing force to dampen the motion exerted by the torque spring.

Abstract: The present invention relates to methods for administering therapeutic doses of bispecific T-cell engaging molecules for the treatment of cancer in a patient. The administration methods reduce the incidence and/or severity of adverse events, such as cytokine release syndrome, and entail administering to a patient a priming dose of the bispecific T-cell engaging molecule by continuous intravenous infusion over a period of days followed by administration of a therapeutic dose of the bispecific T-cell engaging molecule by a bolus intravenous infusion at dosing intervals of at least a week.

Abstract: A drug delivery system is disclosed that includes a drug delivery device having a reservoir and a delivery cannula having a proximal end in fluid communication with the reservoir and a distal end to be received within a patient. The drug delivery system may further include one or more sensors coupled to the drug delivery device, a wireless transmitter, and a controller coupled to the one or more sensors and the wireless transmitter. The controller may be configured to use the one or more sensors to determine a condition or an operational state of the drug delivery device, and control the wireless transmitter to wirelessly transmit one or more reports representative of the condition or the operational state of the drug delivery device. A method for use with a drug delivery device is also disclosed.

Abstract: A drug delivery system is disclosed that includes a drug delivery device having a reservoir and a delivery cannula having a proximal end in fluid communication with the reservoir and a distal end to be received within a patient. The drug delivery system may further include one or more sensors coupled to the drug delivery device, a wireless transmitter, and a controller coupled to the one or more sensors and the wireless transmitter. The controller may be configured to use the one or more sensors to determine a condition or an operational state of the drug delivery device, and control the wireless transmitter to wirelessly transmit one or more reports representative of the condition or the operational state of the drug delivery device. A method for use with a drug delivery device is also disclosed.

Abstract: Systems and methods are disclosed for processing sensor data collected by a drug delivery device with an external computing device. The drug delivery device may include a reservoir and a delivery cannula having a proximal end in fluid communication with the reservoir and a distal end to be received within a patient. The drug delivery device may further include one or more sensors configured to generate sensor data representative of a condition and/or operational state of the drug delivery device, and a communication module configured to transmit information to the external computing device. The external computing device may process the information received from the drug delivery device according to information stored in a memory of the external computing device to determine the condition or the operational state of the drug delivery device and/or generate instructional or informational prompts to be displayed to a user or patient.

Abstract: An injector includes a housing having a syringe assembly and an actuating mechanism at least partially disposed within the housing. The syringe assembly includes a syringe barrel that stores a medicament to be injected into a user, a needle assembly, and a filter member disposed adjacent to the needle assembly. The actuating mechanism is operatively coupled to the syringe assembly and includes a torque spring that exerts a torque to urge the medicament through the filter member to be injected into the user. The actuating mechanism further includes a damper mechanism that exerts an opposing force to dampen the motion exerted by the torque spring.

Abstract: Devices and methods are disclosed for assisting a user of a drug delivery device with an application executing on a mobile computing device. The mobile computing device may receive information from the drug delivery device related to its condition and/or operation and subsequently select an informational and/or instructional prompt to be displayed to the user based on the received information. The mobile computing device may also generate a display in the application including the selected informational prompt and/or the instructional prompt. Accordingly, the user of the drug delivery device can be guided through the drug delivery process in real time, thereby reducing the likelihood of improper or incomplete use of the drug delivery device.

Abstract: A syringe assembly for a drug delivery device. The syringe assembly includes a syringe barrel having a proximal end, a distal end, and a longitudinal axis. A needle assembly is operatively coupled to the syringe barrel and includes a needle hub and a needle attached to the needle hub. A flexible connection is disposed between the syringe barrel and the needle hub and forms a fluid pathway between the syringe barrel and the needle. The flexible connection enables the needle assembly to be moveable from a filling position, in which a longitudinal axis of the needle assembly is parallel to a longitudinal axis of the syringe barrel, to an assembled position, in which the longitudinal axis of the needle assembly is not parallel to the longitudinal axis of the syringe barrel.

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: An insertion mechanism for a drug delivery device. The insertion mechanism includes a proximal end, a distal end, a first opening disposed near the proximal end, and a second opening disposed in the distal end. A needle or cannula assembly is disposed within a housing and has a base with a proximal surface and a distal surface and a needle or cannula coupled to the distal surface. A retraction member is disposed within the housing to maintain the needle or cannula assembly in a retracted position before movement to an extended position, the retraction member in contact with the base. Upon supplying pressure through the first opening until an amount of pressure P1 applies an application force to the proximal surface of the base that surpasses a resistive force of the retraction member, the needle or cannula assembly is moved from the retracted position to the extended position.

Abstract: A drug delivery device includes a housing with at least one pressure communication channel or aperture, which distributes a negative fluid pressure across its base to draw tissue against the device. The device can also include a porous, adhesive layer over the channel(s) or aperture(s), for attaching to tissue. The device can also include a pressure sensor for determining whether there is proper attachment. Further, a bladder may be used instead of the adhesive layer for attaching the device. The bladder, in a partially inflated state, can apply constant pressure across a contact surface causing a flexible adhesive layer attached to the bladder to confirm and adhere to the tissue. Subsequent evacuation of the bladder causes it to deflate and collapse or retract, thereby causing the flexible adhesive layer to pull and stretch the tissue toward the base.

Abstract: A device for connecting tubes for a drug delivery system includes a connecting portion having a first tube channel, a second tube channel, a connecting heating element, and a carriage assembly. The first tube channel is adapted to receive a first tube, and the second tube channel is adapted to receive a second tube. The connecting heating element is positioned adjacent to and/or intersecting the first and second tube channels and is adapted to selectively heat at least a portion of the first and second tube. The carriage assembly moves the heated first and second tubes into end-to-end contact with each other to couple the first and second tubes together.

Abstract: An insertion mechanism for a drug delivery device including a trocar, a housing, and a manifold in fluid communication with a fluid pathway connector and movable relative to the housing between a first manifold position adjacent to a proximal end of the housing and a second manifold position adjacent to a distal end of the housing. A hub carrying the trocar or hollow delivery needle is removably connected to the manifold, the hub being movable relative to the housing between a first hub position adjacent to the proximal end of the housing and a second hub position adjacent to the distal end of the housing. A power source is configured to generate rotational motion. A motion conversion mechanism operatively connects the power source and the hub, and is configured to convert the rotational motion into linear motion of the hub.

Abstract: A drug delivery device includes a container for storing a drug, the container having a stopper for expelling the drug; an injection drive comprising an energy source for directly or indirectly acting on the stopper to expel the drug; a sensor for detecting contact between the drug delivery device and a body of a patient; and a user interface (UI) for activating or causing the activation of the injection drive. The device is operative for drawing attention to the UI, if the sensor detects contact between the drug delivery device and the body of the patient, to thereby indicate that the injection drive is ready to be activated, which activation is the next step in the drug administration process.

Abstract: A drug delivery system is disclosed that includes a drug delivery device having a reservoir, a delivery cannula having a proximal end in fluid communication with the reservoir and a distal end to be received within a patient, and one or more controllable elements. The drug delivery system may further include one or more sensors coupled to the drug delivery device, and a controller coupled to the one or more sensors and the one or more controllable elements. The controller may be configured to use the one or more sensors to determine a condition or an operational state of the drug delivery device. Furthermore, the controller may be configured to control the controllable element based on the condition or the operational state of the drug delivery device and/or identity information stored in a memory onboard the device. A method for use with a drug delivery device is also disclosed.

Abstract: An insertion mechanism for a wearable drug delivery device that deploys a small gauge flexible cannula with support of a coaxial rigid trocar or hollow needle. After insertion, the trocar or hollow needle is withdrawn leaving the cannula in place for drug delivery. The insertion mechanism may also include an insertion mechanism housing having a proximal and distal end, a manifold configured to fluidly connect the hollow interior of the cannula and the fluid pathway connector, and a manifold guide carrying the manifold and movable between a first position and a second position. A hub carries the trocar and is removably connected to the manifold guide. An insertion biasing member may be initially retained in an energized state between the proximal end of the insertion mechanism housing and the hub, and a retraction biasing member may be initially retained in an energized state between the hub and the manifold guide.

Abstract: A drug delivery device includes a container for storing a drug, the container having a stopper for expelling the drug; an injection drive comprising an energy source for directly or indirectly acting on the stopper to expel the drug; a sensor for detecting contact between the drug delivery device and a body of a patient; and a user interface (UI) for activating or causing the activation of the injection drive. The device is operative for drawing attention to the UI, if the sensor detects contact between the drug delivery device and the body of the patient, to thereby indicate that the injection drive is ready to be activated, which activation is the next step in the drug administration process.

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 at least one 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 position, a second position, and a third position relative to the housing and is adapted to restrict external contact with a cannula. The switch assembly causes the power source to provide power to the at least one 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.