Abstract: A drug delivery device includes a housing, a container disposed in the housing, an activation mechanism, a needle insertion mechanism, a fluid flow connection, and a valve in fluid communication with the fluid flow connection and the needle insertion mechanism. The container has an inner volume to contain a medicament which is urged out of the container by the activation mechanism. The needle insertion mechanism is adapted to insert a needle and/or a cannula to deliver the medicament from the container via the fluid flow connection. The valve is in fluid communication with the fluid flow connection and needle insertion mechanism, and is movable between first and second positions. Upon insertion of the needle and/or the cannula, the valve remains in the first position whereby fluid flow is restricted. At a later time, the valve is urged to the second position whereby fluid may flow through the needle or cannula.

Abstract: A drug delivery device includes a housing, a container disposed in the housing, an activation mechanism, and a needle insertion mechanism (NIM). The container has an inner volume to contain a medicament which is urged out of the container by the activation mechanism. The needle insertion mechanism (NIM) is operably coupled with the activation mechanism and includes an actuation assembly adapted to insert a needle and a cannula to deliver the medicament from the container. The actuation assembly is movable between a storage state, a first operational state, a second operational state, and a third operational state to selectively position the needle and the cannula.

Abstract: A drug delivery system includes a drug delivery device that delivers medicament to a user and a storage container having a container body that defines at least one storage compartment. The storage container includes a controller, at least one temperature sensor associated with the at least one storage compartment, at least one temperature control device associated with the at least one storage compartment, and at least one retention mechanism coupled to the storage container. In response to a user input, the controller is adapted to activate the at least one temperature control device to adjust the temperature in the at least one storage compartment to an administration temperature and transmit a signal to the at least one retention mechanism to release the drug delivery device from the at least one storage compartment after the temperature in the at least one storage compartment reaches the administration temperature.

Abstract: A drug delivery device includes a housing releasably coupled with a patient, a container disposed in the housing, a plunger disposed in the container, an activation mechanism, and a seal member. The container includes a wall with an interior surface. The plunger includes an interior surface and is moveably disposed in the container. The interior surfaces of the wall and the plunger define a reservoir adapted to contain a drug. The activation mechanism is adapted to release a drive fluid for moving the plunger through the container to expel the drug therefrom. The seal member is moveably disposed in the container and is adapted to inhibit ingress of the drive fluid into the reservoir.

Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device may include a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. Optionally, a cannula initially disposed about the needle may be included. The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient. Methods of assembly and operation are also provided.

Abstract: A drug delivery device assembly includes an injector body with a proximal end, a distal end, an outer surface, and a knob projecting from the outer surface. A needle assembly is at least partially disposed within the injector body. The needle assembly includes a syringe barrel containing a medicament and a needle or a cannula. A drive assembly is at least partially disposed within the injector body and operably coupled to the needle assembly to urge the medicament through the needle or cannula. An accessory defines a shell and has a proximal end, a distal end, a first opening at the proximal end sized to receive at least a portion of the injector body, and second opening at the distal end. The accessory surrounds a portion of the injector body when the accessory is coupled with the injector body.

Abstract: A drug delivery system includes a drug delivery device that delivers medicament to a user and a storage container having a container body that defines at least one storage compartment. The storage container includes a controller, at least one temperature sensor associated with the at least one storage compartment, at least one temperature control device associated with the at least one storage compartment, and at least one retention mechanism coupled to the storage container. In response to a user input, the controller is adapted to activate the at least one temperature control device to adjust the temperature in the at least one storage compartment to an administration temperature and transmit a signal to the at least one retention mechanism to release the drug delivery device from the at least one storage compartment after the temperature in the at least one storage compartment reaches the administration temperature.

Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device may include a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. Optionally, a cannula initially disposed about the needle may be included. The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient. Methods of assembly and operation are also provided.

Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device may include a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. Optionally, a cannula initially disposed about the needle may be included. The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient. Methods of assembly and operation are also provided.

Abstract: Drug delivery devices and associated heating and/or cooling devices are disclosed. In an example, a drug delivery device includes a housing, a container, a therapy layer, and a first adhesive layer. The housing includes a top wall and a bottom wall. The container is at least partially disposed within the housing. The container has an inner volume to contain a drug. The therapy layer have a first side and a second side. The first side faces the bottom wall and the second side faces away from the bottom wall. The first adhesive layer couples the first side of the therapy layer and the bottom wall. The therapy layer is adapted to at least one of heat or cool an area adjacent an injection site.

Abstract: A delivery device includes a durable housing portion and a separable disposable portion that selectively engage and disengage from each other. The disposable housing portion secures to the patient and may be disposed of after it has been in use for a prescribed period. Components that normally come into contact with a patient or with infusion media are supported by the disposable housing portion for disposal after the prescribed use, while the durable housing portion supports other components such as electronics for controlling delivery of infusion media from the reservoir and a drive device and drive linkage.

Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device includes a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector defines a sterile fluid flowpath between the container and the insertion mechanism. A cannula initially disposed about the needle is included.

Abstract: Drug delivery devices are configured to include a gas-driven piston assembly having a flexible pushrod, a non-linear guide include a non-linear guide pathway at least partially surrounding the flexible pushrod, a cylinder at least partially surrounding the flexible pushrod, and a piston movable within the cylinder in response to the pressurized gas entering the cylinder. Some arrangements include a roller pushrod guide system and/or a gear pushrod guide system.

Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device includes a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector defines a sterile fluid flowpath between the container and the insertion mechanism. A cannula initially disposed about the needle is included.

Abstract: A drug delivery device includes a housing defining a shell and an inner volume, a container, a drive mechanism, a needle assembly, a fluid flow connection, and a backflow prevention mechanism. The container has an inner volume to contain a medicament to be administered to a user. The drive mechanism is at least partially disposed within the housing and exerts a force to urge the medicament out the container. The fluid flow connection is coupled to the container and the needle assembly and allows the medicament to flow from the container to the needle assembly to be administered. The backflow prevention mechanism is associated with at least one of the container, the fluid flow connection, or the needle assembly and includes at least one flow restrictor to restrict a fluid from flowing from the needle assembly to the container.

Abstract: A delivery device includes a durable housing portion and a separable disposable portion that selectively engage and disengage from each other. The disposable housing portion secures to the patient and may be disposed of after it has been in use for a prescribed period. Components that normally come into contact with a patient or with infusion media are supported by the disposable housing portion for disposal after the prescribed use, while the durable housing portion supports other components such as electronics for controlling delivery of infusion media from the reservoir and a drive device and drive linkage.

Abstract: A delivery device includes a durable housing portion and a separable disposable portion that selectively engage and disengage from each other. The disposable housing portion secures to the patient and may be disposed of after it has been in use for a prescribed period. Components that normally come into contact with a patient or with infusion media are supported by the disposable housing portion for disposal after the prescribed use, while the durable housing portion supports other components such as electronics for controlling delivery of infusion media from the reservoir and a drive device and drive linkage.

Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device may include a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. Optionally, a cannula initially disposed about the needle may be included. The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient. Methods of assembly and operation are also provided.

Abstract: A medical device system includes at least one controllable patient-worn or patient-carried medical device, and a plurality of controller devices that are capable of independently controlling features or functions of the patient medical device. Control commands and other data is wirelessly communicated among the patient medical device and the multiple controller devices. A number of techniques, protocols, and other measures are provided to coordinate wireless communication between the various devices in a medical device system. These control command coordination processes address situations where conflicting, redundant, or concurrent control commands might be independently issued by the multiple controller devices.

Abstract: A medical device system includes at least one controllable patient-worn or patient-carried medical device, and a plurality of controller devices that are capable of independently controlling features or functions of the patient medical device. Control commands and other data is wirelessly communicated among the patient medical device and the multiple controller devices. A number of techniques, protocols, and other measures are provided to coordinate wireless communication between the various devices in a medical device system. These control command coordination processes address situations where conflicting, redundant, or concurrent control commands might be independently issued by the multiple controller devices.