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: 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: 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 apparatuses and methods that can provide a delayed bolus calculator for use in closed loop diabetes therapy that can account for additional factors not taken into account in regular meal bolus calculations when a user wants to deliver a meal bolus a period of time after a meal was consumed. A delayed bolus calculator can enable the user to enter a period of time since the meal was consumed in addition to the number of carbohydrates consumed in a meal. This enables the system to account for the amount of increased insulin from the closed loop algorithm in response to the meal and/or the time since the meal to ensure that the risk of hypoglycemia is mitigated while still reducing hyperglycemia.

Abstract: Embodiments of the present disclosure relate to a holder or carrier for a user-wearable infusion pump that can be worn on or near the patient's body. Embodiments depicted and described herein provide a more versatile and secure way to hold and carry a user-wearable infusion pump.

Abstract: Disclosed herein are systems and methods for monitoring performance of an ambulatory infusion pump. An ambualtory infusion pump can include a reservoir configured to contain a medicament including a plunger at a proximal end of the reservoir and an outlet port at a distal end of the reservoir. A motor can be configured to cause linear motion of a pushrod to contact and move the plunger to cause medicament to flow from the reservoir out of the outlet port to a patient. An optical encoder can be employed to monitor a linear position of the pushrod. In addition, the optical encoder can be employed to monitor additional system conditions and/or a secondary encoder can be employed to monitor the performance of the optical encoder.

Abstract: Ambulatory infusion pump systems can integrate a CGM sensor with an ambulatory infusion pump via a pump holder or tray that releasably holds the pump and is configured to be worn by a user. A direct electrical connection between the pump and the CGM can be facilitated by providing a sensor nest within the pump holder that causes an electrical connector on the pump to directly interface with the sensor. By combining the CGM and insulin pump into one integrated system with a direct electrical connection, a more aesthetically pleasing, convenient and reliable system is provided. Diabetes management is simplified by consolidating two essential devices into one.

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: Disclosed herein are apparatuses and methods that can provide a delayed bolus calculator for use in closed loop diabetes therapy that can account for additional factors not taken into account in regular meal bolus calculations when a user wants to deliver a meal bolus a period of time after a meal was consumed. A delayed bolus calculator can enable the user to enter a period of time since the meal was consumed in addition to the number of carbohydrates consumed in a meal. This enables the system to account for the amount of increased insulin from the closed loop algorithm in response to the meal and/or the time since the meal to ensure that the risk of hypoglycemia is mitigated while still reducing hyperglycemia.

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 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 systems and methods for remotely monitoring and/or controlling medical therapy of a patient. Embodiments of the current disclosure provide a remote monitoring and/or control architecture that can establish a predetermined set of permissions for real-time monitoring of patient data and/or notifications and/or control of medical device therapy. The system can include permissions to determine who, how, and when information and/or control is shared that can consider factors, such as time, location, and relationship with the patient.

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: 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: 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: 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: 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. In order to ensure reliable communication of data, more than one component in a system can be capable of relaying data to another component.

Abstract: Disclosed herein are systems and methods for monitoring performance of an ambulatory infusion pump. An ambulatory infusion pump can include a reservoir configured to contain a medicament including a plunger at a proximal end of the reservoir and an outlet port at a distal end of the reservoir. A motor can be configured to cause linear motion of a pushrod to contact and move the plunger to cause medicament to flow from the reservoir out of the outlet port to a patient. An optical encoder can be employed to monitor a linear position of the pushrod. In addition, the optical encoder can be employed to monitor additional system conditions and/or a secondary encoder can be employed to monitor the performance of the optical encoder.

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.