Abstract: Fluid path assemblies for drug delivery devices and methods of establishing a fluid flow path for drug delivery devices are described that include a needle shield valve member that couples to a reservoir having a needle mounted thereto. The needle shield valve member includes an internal barrier that protects the needle and/or contains a drug within the reservoir until activation of the drug delivery device. Upon activation, there is relative movement between the reservoir and needle shield valve member until the needle pierces the barrier to establish a fluid flow path from the reservoir through the needle shield valve member.

Abstract: Drug delivery devices are described that include an escapement activation assembly. The escapement activation assembly includes a slide having a plurality of pallet engagement portions and a switch engagement portion and a pallet having a plurality of slide engagement portions. A drive is coupled to the pallet to cause the pallet to move relative to the slide to move the plurality of slide engagement portions into and out of engagement with the plurality of pallet engagement portions to allow the slide to move along a path within the drug delivery device. Movement of the slide can cause the switch engagement portion to move out of engagement with an activation trigger of a mechanism of the drug delivery device.

Abstract: A drug delivery device includes a housing, a container disposed in the housing, an activation mechanism, a needle assembly, and a temperature indicator. The housing defines an inner volume and includes at least one opening. The container contains a medicament which is urged out of the container by the activation mechanism. The needle assembly has a needle and/or a cannula to deliver the medicament from the container. The temperature indicator is operably coupled with the outer surface of the container and is responsive to a change in temperature of the container.

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 flexible plunger rod, drug delivery mechanism, drug delivery device, and methods are described that utilize the flexible plunger rod perform drug delivery operations. In embodiments, the flexible plunger rod can be stored in a curved configuration to thereby reduce a footprint of the drug delivery mechanism and device.

Abstract: Drug delivery member insertion depth sensing assemblies, drug delivery devices, and methods for determining an insertion depth of a drug delivery member are disclosed. The sensing assemblies can include electrical sensing assemblies with direct or indirect measurement components or optical sensing assemblies with one or more light sources and one or more photodiodes. A controller of the sensing assemblies can receive data associated with the drug delivery member in an insertion position. The data can then be correlated to an insertion depth of the drug delivery member.

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: 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: 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: Drug delivery devices are described that include an escapement activation assembly. The escapement activation assembly includes a slide having a plurality of pallet engagement portions and a switch engagement portion and a pallet having a plurality of slide engagement portions. A drive is coupled to the pallet to cause the pallet to move relative to the slide to move the plurality of slide engagement portions into and out of engagement with the plurality of pallet engagement portions to allow the slide to move along a path within the drug delivery device. Movement of the slide can cause the switch engagement portion to move out of engagement with an activation trigger of a mechanism of the drug delivery device.

Abstract: Fluid path assemblies for drug delivery devices and methods of establishing a fluid flow path for drug delivery devices are described that include a needle shield valve member that couples to a reservoir having a needle mounted thereto. The needle shield valve member includes an internal barrier that protects the needle and/or contains a drug within the reservoir until activation of the drug delivery device. Upon activation, there is relative movement between the reservoir and needle shield valve member until the needle pierces the barrier to establish a fluid flow path from the reservoir through the needle shield valve member.

Abstract: A flexible plunger rod, drug delivery mechanism, drug delivery device, and methods are described that utilize the flexible plunger rod perform drug delivery operations. In embodiments, the flexible plunger rod can be stored in a curved configuration to thereby reduce a footprint of the drug delivery mechanism and device.

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: 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: 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: 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: An interventional device configured for placement in or near an internal organ or tissue is provided. The interventional device includes a reference portion having three or more sensor elements. In one implementation, the interventional device and associated sensor elements provide dynamic referencing of the internal organ, tissue or associated vasculature after registration of the sensor data with images and/or volumetric representations of the internal organ or tissue.