Abstract: Systems and methods for automatically delivering medication to a user. A sensor coupled to a user can collect information regarding the user. A controller can use the collected information to determine an amount of medication to provide the user. The controller can instruct a drug delivery device to dispense the medication to the user. The drug delivery device can be a wearable insulin pump that is directly coupled to the user. The controller can be part of or implemented in a cellphone. A user can be required to provide a confirmation input to allow a determined amount of insulin to be provided to the user based on detected glucose levels of the user. The sensor, controller, and drug delivery device can communicate wirelessly.

Abstract: A low-force, non-displacement, micro/miniature valve and/or pump assembly is provided. A tube component having a first side port coupled to an inlet portion and a second side port coupled to an outlet portion can be selectively moved to alternatively couple the side ports to a first or second piston pump chamber. First and second pistons can be actuated after positioning the tube component to either draw in fluid or push out fluid from either the first or second piston pump chambers during each actuation of the pistons. The fluid can be drawn in from a reservoir and can be expelled to a patient for providing a dose of the fluid to the patient.

Abstract: Disclosed are techniques and devices that are operable to receive one or a number of generalized parameters of an automated insulin delivery algorithm. An input of at least one generalized parameter corresponding to a user may be used to set one or more of the number of specific parameters of the automated insulin delivery algorithm based on the inputted at least one generalized parameter. Physiological condition data related to the user may be collected. The automated insulin delivery algorithm may determine a dosage of insulin to be delivered based on the collected physiological condition. Signals may be output to cause a liquid drug to be delivered to the user based on an output of the automated insulin delivery algorithm related to the determined dosage of insulin.

Abstract: A wearable drug delivery device for monitoring unintended over-delivery and/or under-delivery of a stored liquid drug are provided. An absolute pressure sensor can be positioned within the fluid path of the drug delivery device. The absolute pressor sensor can detect both ambient pressure (e.g., absolute or atmospheric pressure) and relative pressure (gage or pumping pressure). Based on the detected pressures, the effects of external ambient pressure on air with the fluid path can be determined during both intended drug delivery events and unintended drug delivery events. In turn, under-delivery and/or over-delivery of the liquid drug can be determined. Based on the severity of the determined under-delivery or over-delivery of the liquid drug, alarms indicating different urgencies can be provided to the user.

Abstract: Disclosed are examples of valve systems and methods of operating the respective valve systems. An example valve system may include a valve body, an inlet component, an outlet component and a valve tube. The valve body may include a first void and a second void. The inlet component may be coupled to the first void and the outlet component may be coupled to the second void. The valve tube may include a side port and may be positioned through the valve body and coupled to the first void, the inlet component, the second void, and the outlet component. Other valve system examples may include including a valve body, a first septum, a second septum, a first piston, a second piston and a tube. The disclosed methods describe the interaction of the respective components of the respective valve system example.

Abstract: Disclosed is a fluid delivery device including a fluid reservoir and a transcutaneous access tool fluidly coupled to the fluid reservoir, wherein the transcutaneous access tool includes a needle or a trocar. The fluid delivery device may further include a transcutaneous access tool insertion mechanism for deploying the transcutaneous access tool, wherein the insertion mechanism is configured to insert and retract the needle/trocar in a single, uninterrupted motion.

Abstract: Disclosed are techniques to establish a modified pump rate that mitigates the effects of a pump occlusion and enables a recommended dosage of insulin to be output by a pump mechanism over the course of a control cycle. In an example, the pump rate may be reduced by adding a calculated time interval between application of actuation commands to extend the amount of time over which insulin may be output by the pump mechanism.

Abstract: Drive systems for a drug delivery device are provided. The drive systems can be positioned within a container that stores a liquid drug to be delivered to a user. The drive systems can be coupled to a plunger positioned within the container. The drive systems can be incrementally advanced to drive the plunger further into the container, thereby expelling a portion of the stored liquid drug from the container for delivery to the user. The container can be any type of container including a pre-filled, standardized drug cartridge. The drive systems and container can be components of a wearable drug delivery device.

Abstract: Disclosed are examples of reservoir and reservoir systems usable with a wearable drug delivery device. An example reservoir may include a flexible component coupled to a shell component. The shell component may include drainage channels to facilitate extraction of the liquid drug from the reservoir. A reservoir system example may include an exoskeleton configured around a flexible reservoir to guide the expansion and collapse of the flexible reservoir. Alternatively, one or more rigid panels may be coupled to corresponding flat surfaces of the flexible reservoir to guide the expansion and collapse of the flexible reservoir. A further reservoir example may include a flexible thin film reservoir having peel-able restraints configured to seal off corresponding sections of the reservoir, sequentially break, enabling the liquid drug to sequentially fill corresponding sections in a controlled and predicable manner. A wearable drug delivery device example suitable for utilizing the described examples is provided.

Abstract: Drug delivery systems with reduced hold-up volumes are provided. The drug delivery systems include a cartridge configured to hold a liquid drug. A cartridge stopper is positioned in a first portion of the cartridge. A needle guide component is positioned within the cartridge stopper. A needle is positioned within a central opening of the needle guide. A plunger is positioned in a second portion of the cartridge. The plunger includes a fluid path pocket facing and aligned with the central opening of the needle guide component. The plunger is driven toward the cartridge stopper to expel the liquid drug from the cartridge through the needle. An end of the needle can be positioned within the fluid path pocket when the plunger is pushed against the cartridge stopper, ensuring that only a small volume of the liquid drug remains in the cartridge when delivery of the liquid drug is completed.

Abstract: A wearable drug delivery device, techniques, and computer-readable media that provide an application that implements a diabetes treatment plan for a user are described. The drug delivery device may include a controller operable to direct operation of the wearable drug delivery device. The controller may provide a selectable activity mode of operation for the user. Operation of the drug delivery device in the activity mode of operation may reduce a likelihood of hypoglycemia during times of increased insulin sensitivity for the user and may reduce a likelihood of hyperglycemia during times of increased insulin requirements for the user. The activity mode of operation may be manually activated by the user or may be activated automatically by the controller. The controller may automatically activate the activity mode of operation based on a detected activity level of the user and/or a detected location of the user.

Abstract: Disclosed are techniques to establish initial settings for an automatic insulin delivery device. An adjusted total daily insulin (TDI) factor usable to calculate a TDI dosage may be determined. The adjusted TDI factor may be a TDI per unit of a physical characteristic of the user (e.g., weight) times a reduction factor. The adjusted TDI factor may be compared to a maximum algorithm delivery threshold. Based on the comparison result, the application or algorithm may set a TDI dosage and output a control signal. Blood glucose measurement values may be collected from a sensor over a period of time. A level of glycated hemoglobin of the blood may be determined based on the obtained blood glucose measurement values. In response to the level of glycated hemoglobin, the set TDI dosage may be modified. A subsequent control signal including the modified TDI dosage may be output to actuate delivery of insulin.

Abstract: A medical device comprising an infusion device comprising a fluid reservoir to contain a therapeutic fluid and a transcutaneous access tool fluidly coupled to the fluid reservoir, the transcutaneous access tool configured to deliver the therapeutic fluid subcutaneously to a patient; wherein the infusion device operates in a stand-by mode prior to the therapeutic fluid being introduced into the fluid reservoir; wherein the infusion device operates to deploy the transcutaneous access tool within a predetermined deployment time period upon filling the fluid reservoir to a predetermined fill level with the therapeutic fluid.

Abstract: Disclosed are a system, methods and computer-readable medium products that provide safety constraints for an insulin-delivery management program. Various examples provide safety constraints for a control algorithm-based drug delivery system that provides automatic delivery of a drug based on sensor input. Glucose measurement values may be received at regular time intervals from a sensor. A processor may predict future glucose values based on prior glucose measurement values. The safety constraints assist in safe operation of the drug delivery system during various operational scenarios. In some examples, predicted future glucose values may be used to implement safety constraints that mitigate under-delivery or over-delivery of the drug while not overly burdening the user of the drug delivery system and without sacrificing performance of the drug delivery system. Other safety constraints are also disclosed.

Abstract: A drug delivery device may include an Inertial Measurement Unit (IMU) is provided. The IMU may include an accelerometer, a magnetometer, or a gyroscope. Motion parameters may be detected when the drug delivery device is shipped, being prepared for activation for use, or during use. The IMU may provide data indicative of a rapid deceleration, such as when a package containing the drug delivery device is dropped, or some other physical event experienced by the drug delivery device. The drug delivery device may also include internal or external pressure sensors or a blood glucose sensor that may coordinate with the IMU to provide additional feedback regarding the status of the device or user. A controller of the drug delivery device may generate a response depending on the particular parameters being monitored or may change device operational parameters as a result of detected system events.

Abstract: Exemplary embodiments described herein relate to a closed loop artificial pancreas system. The artificial pancreas system seeks to automatically and continuously control the blood glucose level of a user by emulating the endocrine functionality of a healthy pancreas. The artificial pancreas system uses a closed loop control system with a cost function. The penalty function helps to bound the infusion rate of insulin to attempt to avoid hypoglycemia and hyperglycemia. However, unlike conventional systems that use a generic or baseline parameter for a user's insulin needs in a cost function, the exemplary embodiments may use a customized parameter in the cost function that reflects the individualized insulin needs of the user. The use of the customized parameter causes the cost function to result in insulin dosages over time better suited to the individualized insulin needs of the user. This helps to better avoid hypoglycemia and hyperglycemia.

Abstract: Disclosed are examples of a device, a system, methods and computer-readable medium products operable to implement functionality to determine and respond to a purpose of a meal. An algorithm or application may receive data that may include data related to a meal purpose from data sources and determine whether any of the data received from the plurality of data sources was received from a direct data source or an indirect data source. The data may be evaluated to determine a purpose of the meal. Based on the results of the evaluation, instructions may be generated to provide an appropriate response based on the determined purpose of the meal. The generated instructions to provide the appropriate response based on the determined purpose of the meal may be output.

Abstract: A system for sterilizing a drug delivery device includes a drug delivery device having a first self-healing seal configured to seal a fluid reservoir disposed within the drug delivery device. A sealable container is configured to receive the drug delivery device therein. The sealable container has a base portion and a cover portion. The cover portion has a second self-healing seal positioned to align with the first self-healing seal when the drug delivery device is disposed within the sealable container. A fill port includes a fill path, the fill path being configured to pass through the first and second self-healing seals to fluidly couple the fill port to the reservoir of the drug delivery device. Other systems, methods, and devices of sterilization are also disclosed.