Abstract: Embodiments of the present disclosure enable a user-wearable infusion pump that may have a limited user interface including no display to execute and provide feedback on a number of functions. A remote control device having a display can be used to control the infusion pump. The infusion pump can include one or more indicator lights that can be indicate different statuses with different light patterns. The remote control device can include a display screen that provides further information relating to various pump statuses.

Abstract: Apparatuses and methods for transitioning to sleep mode or otherwise modified glucose target range in automated insulin delivery systems. For example, sleep mode can include a lower glucose target and/or lower and narrower glucose target range because of fewer variables that affect glucose values during sleep such as eating and exercise. Due to increased stability provided by the sleep mode target range, it is desirable to transition to the sleep mode target range as quickly as possible, while ensuring the transition is done safely and does not risk low glucose or hypoglycemia by too quickly switching to the lower and narrower target range. Systems and methods disclosed herein therefore provide various approaches for safely and quickly transitioning to sleep mode or other modified target ranges in order to improve time in range by being more aggressive to get to the lower sleep mode or other target faster without risking hypoglycemia.

Abstract: A patch pump utilizes piezoelectricity to dispense medicament from a cartridge syringe to a patient. Pump can include a plurality of piezoelectric elements that when energized cause linear motion of a pushrod that interfaces with the syringe in the cartridge to advance the syringe and dispense the medicament. The high torque generated by the piezoelectric elements is directly converted into the same amount of torque on the lead screw, so no torque increasing gear reduction system is needed and the pushrod utilized to drive the syringe can be contained within and connected directly to the motor assembly. Such a piezoelectric-based system can therefore be made smaller and with fewer moving parts than an electromagnetic motor of the same capability such that the pump has a smaller size than has heretofore been possible with prior art electromagnetic-based syringe pumps and other pumps that utilize gear reduction systems.

Abstract: Disclosed herein are methods for establishing communication protocols between wireless devices in infusion pump systems. Infusion pump systems can include a number of components capable of wireless communication with one or more other components including an infusion pump, a continuous glucose monitoring (CGM) system, a smartphone or other multi-purpose consumer electronic device and/or a dedicated remote controller for the infusion pump. Communications among these devices can be coordinated to increase efficiency and conserve battery power.

Abstract: A patch pump utilizes piezoelectricity to dispense medicament from a cartridge syringe to a patient. Pump can include a plurality of piezoelectric elements that when energized cause linear motion of a pushrod that interfaces with the syringe in the cartridge to advance the syringe and dispense the medicament. The high torque generated by the piezoelectric elements is directly converted into the same amount of torque on the lead screw, so no torque increasing gear reduction system is needed and the pushrod utilized to drive the syringe can be contained within and connected directly to the motor assembly. Such a piezoelectric-based system can therefore be made smaller and with fewer moving parts than an electromagnetic motor of the same capability such that the pump has a smaller size than has heretofore been possible with prior art electromagnetic-based syringe pumps and other pumps that utilize gear reduction systems.

Abstract: A user-wearable patch pump system for delivery of insulin or other medicament can include a pump and an attachment portion that attaches the pump to a user's body. The pump can include a drive unit and a disposable cartridge containing a medicament with the drive unit configured to cause the pump to deliver the medicament in the cartridge to the user. The attachment portion can include a retention frame configured to selectively retain the pump therein and an adhesive patch configured to be attached to the user's body. The pump can be selectively attached to the retention frame and used to deliver medicament either through a cannula to an infusion site directly beneath the retention frame or through tubing to an infusion site displaced from the retention frame.

Abstract: Disclosed herein are methods for establishing communication protocols between wireless devices in infusion pump systems. Infusion pump systems can include a number of components capable of wireless communication with one or more other components including an infusion pump, a continuous glucose monitoring (CGM) system, a smartphone or other multi-purpose consumer electronic device and/or a dedicated remote controller for the infusion pump. Communications among these devices can be coordinated to increase efficiency and conserve battery power.

Abstract: Devices and methods for filling a medicament cartridge of a pump, including a user-wearable, ambulatory infusion pump. A device for supporting a medicament cartridge can comprise a body portion resembling a tray, with recesses disposed therein to support one or more of a cartridge body, cartridge tubing, interconnect fitting, and vial adapter. The recesses of the tray may be shaped to correspond to that component intended to be placed in its respective recess so to provide a visual indication to a user how to couple and align the various components necessary to fill the cartridge.

Abstract: A user-wearable patch pump system for delivery of insulin or other medicament can include a pump and an attachment portion that attaches the pump to a user's body. The pump can include a drive unit and a disposable cartridge containing a medicament with the drive unit configured to cause the pump to deliver the medicament in the cartridge to the user. The attachment portion can include a retention frame configured to selectively retain the pump therein and an adhesive patch configured to be attached to the user's body. The pump can be selectively attached to the retention frame and used to deliver medicament either through a cannula to an infusion site directly beneath the retention frame or through tubing to an infusion site displaced from the retention frame.

Abstract: A user-wearable patch pump system for delivery of insulin or other medicament can include a patch pump having a reusable drive unit and a replaceable and refillable cartridge. The cartridge can selectively attach to and be detached from the drive unit. The cartridge can initially be inserted onto the drive unit in a first orientation at an angle to the drive unit and then be rotated to align the cartridge with the drive unit and lock the cartridge in place on the drive unit to form the patch pump.

Abstract: Disclosed herein are systems and methods for mitigating the risk of insulin stacking in automated insulin delivery systems. In AID systems configured to both automatically calculate insulin delivery based on glucose levels and receive manual programming of meal boluses configured to counteract carbohydrates in a meal, insulin stacking can result if the system automatically increases insulin delivery based on a rise in glucose levels in response to consumption of a meal and the user later programs a meal bolus for the meal. The risk of such double dosing is mitigated by the systems and methods disclosed herein by enabling the system to account for recent automated insulin increases when a meal bolus is programmed.

Abstract: Embodiments of the present disclosure enable a user-wearable infusion pump that may have a limited user interface including no display to be paired with a remote control device that can include a remote consumer electronic device such as a smartphone and/or a dedicated remote controller.

Abstract: Disclosed herein are systems and methods incorporating an ambulatory infusion pump and a CGM. These systems that can include software and related methods to provide improved automated insulin delivery algorithms that enable the algorithms to safely continue delivering insulin for some time periods of missing or known inaccurate glucose values.

Abstract: Devices and methods for filling a medicament cartridge of a pump, including a user-wearable, ambulatory infusion pump. A device for supporting a medicament cartridge can comprise a body portion resembling a tray, with recesses disposed therein to support one or more of a cartridge body, cartridge tubing, interconnect fitting, and vial adapter. The recesses of the tray may be shaped to correspond to that component intended to be placed in its respective recess so to provide a visual indication to a user how to couple and align the various components necessary to fill the cartridge.

Abstract: A method of assembling a rotor is provided, in which each rotor disk comprising a connecting element. The method includes: (a) applying heat to a localized region of a first rotor disk of a plurality of rotor disks to selectively deflect a first connecting element of the first rotor disk, wherein the first rotor disk is stationary during heating; (b) installing the first rotor disk onto a rotor stack containing at least one rotor disk; and (c) repeating steps (a) and (b) for each rotor disk of the plurality of rotor disks; and (d) allowing the rotor disks, when stacked, to cool. When cooled, the respective connecting element of each rotor disk that has been selectively deflected contracts into an interference fit with an adjacent rotor disk. A system for selectively heating a localized region of a rotor disk is also provided.

Abstract: Embodiments of the present disclosure enable a user-wearable infusion pump that may have a limited user interface including no display to be paired with a remote control device that can include a remote consumer electronic device such as a smartphone and/or a dedicated remote controller.

Abstract: Disclosed herein are apparatuses and methods incorporating an infusion pump and a CGM that can include software that automatically populates a blood glucose section of a bolus calculator with a most recent valid CGM value. The software can additionally be programmed to automatically populate the bolus calculator with a single CGM reading only when one or more predefined conditions are met that aid in mitigating the risk of inaccurate and/or invalid single CGM readings.

Abstract: A user-wearable patch pump system for delivery of insulin or other medicament can include a patch pump having a reusable drive unit and a replaceable and refillable cartridge. The cartridge can selectively attach to and be detached from the drive unit. The cartridge can initially be inserted onto the drive unit in a first orientation at an angle to the drive unit and then be rotated to align the cartridge with the drive unit and lock the cartridge in place on the drive unit to form the patch pump.

Abstract: Disclosed herein are apparatuses and methods that account for exercise in closed loop insulin delivery systems. Rather than increasing a target insulin on board (IOB) as glucose levels rise, which would increase insulin delivery to address the raised glucose levels, when a user indicates that the user will be exercising raised glucose levels are addressed by reducing the target IOB within the closed loop algorithm. By reducing the target IOB, the algorithm responds less aggressively to pre-exercise food, and does not build up the IOB that can cause dangerously low glucose levels once the exercise also begins lowering glucose levels.

Abstract: Disclosed herein are methods for establishing communication protocols between wireless devices in infusion pump systems. Infusion pump systems can include a number of components capable of wireless communication with one or more other components including an infusion pump, a continuous glucose monitoring (CGM) system, a smartphone or other remote consumer electronic device and/or a dedicated remote controller for the infusion pump. The present disclosure provides various methods for simplifying connections among these devices.