Abstract: The disclosed embodiments are directed to a wearable automatic drug delivery device configured to provide basal dosing of GLP-1 or co-formulation of GLP-1 and insulin. The size and frequency of the basal doses may be controlled by a medication delivery algorithm resident on the wearable drug delivery device based on a basal dosing history and readings from a continuous glucose monitor monitoring the glucose levels of the wearer of the device.

Abstract: A wearable drug delivery device that can deliver a liquid drug stored in a container to a patient or user is provided. A soft needle or cannula can be placed in fluid communication with the liquid drug and can be coupled to a needle insertion component that provides access to the patient. A drive system of the drug delivery device can expel the liquid drug from the container to the patient through the soft needle or cannula. The wearable drug delivery device can include components for preventing backflow and eliminating air within the liquid drug. As a result, the comfort of the patient can be enhanced and correct drug dosages can be provided when using the drug delivery device.

Abstract: A wearable drug delivery device that can deliver a liquid drug stored in a container to a patient is provided. The container can be a prefilled cartridge that can be loaded into the drug delivery device by the patient or that can be preloaded within the drug delivery device when provided to the patient. A sealed end of the container is pierced to couple the stored liquid drug to a needle conduit that is coupled to a needle insertion component that provides access to the patient. A drive system of the drug delivery device can expel the liquid drug from the cartridge to the patient through the needle conduit. The drive system can be controlled to provide the liquid drug to the patient in a single dose or over multiple doses.

Abstract: Exemplary embodiments may address the problem of missing blood glucose concentration readings from a glucose monitor that transmits blood glucose concentration readings over a wireless connection due to problems with the wireless connection. In the exemplary embodiments, an automated insulin delivery (AID) device uses an estimate in place of a missing blood glucose concentration reading in determining a predicted future blood glucose concentration reading for a user. Thus, the AID device is able to operate normally in generating insulin delivery settings despite not receiving a current blood glucose concentration reading for a current cycle. There is no need to suspend delivery of insulin to the user due to the missing blood glucose concentration reading.

Abstract: Systems and methods for automatically delivering medication to a user. An automated drug delivery system may include a sensor and a wearable automated drug delivery device. The wearable automated drug delivery device may be configured to couple to the skin of a user and may include a controller and a pump. The pump may be configured to output the medication. The controller may be within the wearable automated drug delivery device. The sensor may be coupled to the user and may be configured to collect information regarding the user. The controller of the wearable automated drug delivery device may use the collected information to locally determine an amount of medication to be output from the wearable automated drug delivery device and cause delivery of the amount of medication.

Abstract: The exemplary embodiments attempt to identify impending hypoglycemia and/or hyperglycemia and take measures to prevent the hypoglycemia or hyperglycemia. Exemplary embodiments may provide a drug delivery system for delivering insulin and glucagon as needed by a user of the drug delivery system. The drug delivery system may deploy a control system that controls the automated delivery of insulin and glucagon to a patient by the drug delivery system. The control system seeks among other goals to avoid the user experiencing hypoglycemia or hyperglycemia. The control system may employ a clinical decision support algorithm as is described below to control delivery of insulin and glucagon to reduce the risk of hypoglycemia or hyperglycemia and to provide alerts to the user when needed. The control system assesses whether the drug delivery system can respond enough to avoid hypoglycemia or hyperglycemia and generates alerts when manual action is needed to avoid hypoglycemia or hyperglycemia.

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: In an automated insulin delivery device, fuzzy logic may be applied to the responding to the possibility of a user taking additional action that may affect the blood glucose concentration. Fuzzy sets may be defined for empirically derived different likelihoods of the user taking such additional action based on correlated factors. A membership function may be provided for each fuzzy set. The membership function may provide a probability of membership in the set based on a parameter. Each fuzzy set may have a response that is reflective of the likelihood of additional user action associated with the fuzzy set. The responses by the AID device to each of these cases may reflect the probability of each such case occurring as evidenced by empirical data.

Abstract: Exemplary embodiments may provide an improved approach to automated insulin delivery by more accurately estimating the total daily insulin (TDI) of a user. As a result, less insulin is wasted by the delivery system, and the estimate of TDI more closely matches a user's actual daily insulin needs. Hence, the user need not refill the insulin reservoir excessively or need not fret unnecessarily about running out of insulin prematurely. The estimate relies on the history of actual automated insulin deliveries and thus reflects the actual insulin delivered to the user more accurately than conventional approaches.

Abstract: Systems for piercing a septum of a drug delivery device is disclosed. The drug delivery device may include a needle conduit having an end and a drug container having a septum. The septum piercing mechanism may include a needle support operatively coupled to the needle conduit. The septum piercing mechanism may be movable from a first, unactivated configuration to a second, activated configuration. In the unactivated configuration, the septum seals an interior of the drug container from the end of the needle conduit. In the activated configuration, the end of the needle conduit pierces through the septum placing the needle conduit in fluid communication with the drug container. In one embodiment, activation may cause the needle support to move towards the drug container. In one embodiment, the needle support may be moved by a biasing member. Alternatively, in another embodiment, the needle support may be moved by a cam mechanism.

Abstract: The present disclosure relates generally to the field of drug delivery. In particular, the present disclosure relates to a drug delivery system that includes a sealed and sterile fluid path attached to a drug-loaded container. The disclosure further relates to methods for sterilizing a portion of the drug delivery system without exposing the drug-loaded container to harmful sterilization parameters.

Abstract: Disclosed are a device, system, methods and computer-readable medium products that provide techniques for evaluating and modifying a duration of insulin action setting usable by an automatic medication delivery algorithm, such as an artificial pancreas application.

Abstract: Disclosed herein are wearable drug delivery devices and methods for component positioning of a linear shuttle pump. In some approaches, a pump may include a pump chamber operably coupled with a piston, and a detent apparatus, wherein the detent apparatus comprises a detent body, a detent arm, and a detent engagement member. The detent engagement member may be retained in direct physical contact with first or second arrest locations of either the detent body or the detent arm. The pump may further include a piston grip coupled to the piston, the piston grip including a grip component engaged with an exterior of the piston. Movement of the piston grip may cause the piston to move axially relative to the pump chamber to control receipt and delivery of a liquid drug.

Abstract: A method for sterilizing a drug delivery device may comprise disposing a liquid drug container, a needle conduit and a cap in a sterilization enclosure so that a mouth portion of the liquid drug container is registered with, and spaced apart from, a circumferential lip of the cap; disposing a cover over the liquid drug container, the needle conduit, and the cap, sealing the sterilization enclosure; subjecting the interior of the sterilization enclosure to a sterilization process in which the liquid drug container, the needle conduit, and the cap are exposed to the sterilization fluid and are sterilized; and applying a downward force to the liquid drug container to move the mouth portion into engagement with the circumferential lip of the cap and to snap the cap onto the liquid drug container to seal the cap and needle conduit to the liquid drug container in an assembled configuration.

Abstract: A fluid flow regulator of a fluid delivery system that can adjust a flow rate of a liquid drug dispensed from a liquid drug container to a user is provided. The fluid flow regulator can be coupled to an end of the liquid drug container. The fluid flow regulator can include a compliance plate and a flow channel selector plate having a fluid flow channel. The flow channel selector plate can be rotated relative to the compliance plate and the liquid drug container to expose a selected portion of the fluid flow channel to openings in the compliance plate that are in fluid communication with the liquid drug stored in the liquid drug container. The selected portion of the fluid flow channel can correspond to a corresponding flow resistance of the liquid drug through the fluid flow channel, thereby regulating the flow of the liquid drug to the user.

Abstract: A needle mechanism module for automatically inserting a fluid path into a patient for drug delivery is provided. The needle mechanism module can be a component of a wearable drug delivery device. The needle mechanism module can insert a needle and cannula into the patient responsive to activation of the drug delivery device by a user. After insertion, the needle can be automatically retracted, leaving only the cannula in the patient. As a result, discomfort of the user is reduced.

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: Ratchet-based drive systems for more reliable and safer drug delivery are provided. The ratchet-based drive systems restrict angular movement and/or linear movement of components that cause a plunger to expel a liquid drug from a drug container. Movement of the components can be restricted to correspond to a predetermined or desired portion of the liquid drug. In the case that control of the drive system is lost or fails, the maximum amount of drug that could be delivered is limited to a known amount, thereby reducing the likelihood of an overdose.

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: A multi-stage drug delivery system having a cartridge and multiple plungers positioned in the cartridge and spaced apart from one another is provided. A first plunger, a second plunger, and the cartridge form a first chamber storing a first drug. The second plunger and the cartridge form a second chamber storing a second drug. A cannula pierces the first plunger to access the first drug. As the first plunger is driven toward the second plunger, the first drug is expelled from the first chamber for delivery to a patient through the cannula. After expelling the first liquid drug, the cannula can pierce the second plunger to access the second drug. As the first and second plungers are together driven toward a closed end of the cartridge, the second liquid drug is expelled from the second chamber for delivery to the patient through the cannula.