Abstract: Systems for measuring analyte in a user-body of a patient, delivering medicaments to the user-body, and deployment of components thereof are disclosed. The systems include combinations of an analyte sensor, an automated medicament delivery system, a cradle configured to hold the analyte sensor and the automated medicament delivery system on the user-body, and a deployment inserter configured to deploy one or more of the analyte sensor, the automated medicament delivery system, and the cradle onto the user-body.

Abstract: Disclosed herein is a system and method providing an improvement to a medical device such as a wearable CGM as part of an automated drug delivery system. The improvement provides optical energy to the wound site caused by the insertion of a sensing element into the skin of the user to hasten the healing of the wound, resulting in an improvement in the accuracy of readings for the CGM in a timelier manner. This tends to lessen the effect of the warm-up period of the CGM and improves the response of the automated drug delivery system to better manage the user's blood glucose levels.

Abstract: Compensation may be provided for the varying accuracy levels of a sensor over time. As a result of the compensation, the medicament delivery device may perform better. The sensor may provide input to a medicament delivery device, and the input may be used to determine a dose of medicament to be delivered to a user by the medicament delivery device. A degree of inaccuracy of sensor values may be determined based on when in the lifetime a sensor value is generated. Glucose level values read by a glucose monitor, such as a CGM, may be directly modified before being used by an automated insulin delivery (AID) control of an insulin delivery device. The compensation for the inaccuracy of the glucose level values from the glucose monitor instead may be achieved by modifying a weight coefficient of a glucose cost component of a cost function in one example.

Abstract: Disclosed are systems, processes and techniques implementable in and by medical devices that utilize the subcutaneous region of the skin. In the disclosed examples, an insertion mechanism is provided that inserts a cannula or sensing element into the subcutaneous region of the skin a first distance and retracts the inserted cannula or sensing element a second distance that is smaller than the first distance to create a cavity below the inserted cannula or sensing element. The retracted cannula or sensing element remains inserted in the subcutaneous region of the skin. The cavity provides an area for the effects of a wound response to occur and thereby mitigates possibility of occlusion and/or encapsulation of the inserted cannula or sensing element.

Abstract: Invasive glucose sensors and noninvasive glucose sensors may be used in conjunction to improve glucose management for a user. The rate of change (ROC) of glucose levels from a noninvasive glucose sensor may be used rather than or in conjunction with a glucose level of the user from a CGM. A basal insulin delivery rate to the user may be adjusted responsive to the ROC glucose level data from the noninvasive sensor. The glucose level ROC from a noninvasive glucose sensor may be used to predict future glucose level ROCs of the user between operational cycles of an insulin delivery device and/or to identify possible hypoglycemic or hyperglycemic events. These predicted future glucose level ROCs may be used in a cost function of the control system of the insulin delivery device to select basal insulin delivery doses. Glucose level readings may be used to calibrate a noninvasive glucose level sensor.

Abstract: Exemplary embodiments may provide an on-body medicament delivery system that provides basal delivery of a medicament to a type 2 diabetes patient and that automatically performs medicament titration for the patient. The medicament delivery system performs medicament titration based on glucose level readings for the patient. These glucose levels may be provided wirelessly from a glucose sensor, such as a continuous glucose monitor, or may be entered manually by the patient into a management device, such as a smartphone running an application that provides a user interface for the patient to enter the glucose level readings. The medicament delivery system adjusts the basal medicament delivery rate/dose based on the glucose level readings for the patient. The adjustments may be performed by a programmatic mechanism, such as by computer programming instructions executing on a processor.

Abstract: Disclosed herein is a system and method for calculating an expected peak blood glucose level of user during a post-prandial period, based on a quantity of carbohydrates to be ingested. The user's expected peak blood glucose levels for slow, medium and fast acting carbohydrates are calculated. The results are presented to the user to allow the user to make an informed decision regarding the type of meal to be ingested.

Abstract: Disclosed herein is a system and method implementing a software-based method for detecting or confirming the detection of occlusions in the fluid path of an automatic drug delivery system. The invention uses real time glucose readings from a continuous glucose monitor in collaboration with past insulin delivery history and user indications of ingestion of carbohydrates, to determine cases where the user's glucose concentration is not being sufficiently impacted by the expected insulin delivery, which may indicate a significant pump site issue.

Abstract: Disclosed herein is a system for detecting and handling occlusions in the fluid path of the drug delivery device. The system includes a sensor disposed in-line with the fluid path for determining a change in pressure within the fluid path. The system further includes a machine learning model for analyzing readings from the sensor to detect and classify an occlusion in the fluid path based on the time series of readings from the sensor indicating a change in pressure. The system further takes remedial action to either compensate for the occlusion, clear the occlusion, or inform the user of the existence of the occlusion and recommends a course of action to the user.

Abstract: A drug delivery device including a reservoir operable to contain a liquid drug, a fluid outlet including an outlet reservoir opening and an outlet fluid channel, wherein the outlet reservoir opening has a volume and is fluidly coupled to the outlet fluid channel, and an outlet filter plug operable to fill the volume of the outlet reservoir opening and collect particulate material as the liquid drug is expelled from the reservoir.

Abstract: Disclosed herein is a drug delivery system wherein wearable components of the system are provided with Wi-Fi and/or cellular capabilities such as to allow different modalities for inter-component communications and, further, to allow access to a plethora of cloud-based services to enhance the functionality of the system.

Abstract: Disclosed herein is a combination of an automated insulin delivery system and a continuous glucose monitor integrated into a single, wearable package. The system may use any combination of delivery methods and detection methods, wherein the delivery methods include a cannula, a microneedle array, and a transdermal patch, and wherein the detection methods include electrochemical methods, opto-fluorescent methods, and spectrographic methods.

Abstract: Ambulatory infusion pumps, pump assemblies, cartridges, baseplates, cannulas, insertion tools, and related components as well as combinations thereof and related methods.

Abstract: Ambulatory infusion pumps, pump assemblies, cartridges, baseplates, cannulas, insertion tools, and related components as well as combinations thereof and related methods.

Abstract: Some embodiments of an infusion pump device may include a drive system that accurately and incrementally dispenses fluid from the pump device in a controlled manner. Particular embodiments of the drive system may include a rotational motor that is coupled to a string member, which is used to adjust a pawl relative to a ratchet body. In such circumstances, the drive system can provide a reliable and compact infusion pump device that accurately dispenses the desired volume of fluid.

Abstract: Ambulatory infusion pumps, pump assemblies, cartridges, baseplates, cannulas, insertion tools, and related components as well as combinations thereof and related methods.

Abstract: Some embodiments of a medical infusion pump system include a pump device having a cap device that mates with a pump housing to retain a medicine cartridge therein. In addition to retaining the medicine cartridge in the pump housing, the cap device may perform a number of preparatory functions or safety functions. In addition or in the alternative, some embodiments of the pump device may include a drive system that advances a piston rod to dispense medicine to the patient in a safe and energy efficient manner.

Abstract: Ambulatory infusion pumps, pump assemblies, cartridges, baseplates, cannulas, insertion tools, and related components as well as combinations thereof and related methods.

Abstract: Some embodiments of a medical infusion pump system include a pump device having a flexible pushrod that can adjust from a curved configuration to a generally straight configuration. The flexible pushrod is part of a drive system of the pump device so that the flexible pushrod can be controllably and incrementally advanced toward a medicine reservoir to incrementally dispense the medicine therein. In particular embodiments, the flexible pushrod may comprise an anti-rotation mechanism, an anti-torsion mechanism, or a combination thereof.

Abstract: Some embodiments of a medical infusion pump system include a pump device having a cap device that mates with a pump housing to retain a medicine cartridge therein. In addition to retaining the medicine cartridge in the pump housing, the cap device may perform a number of preparatory functions or safety functions. In addition or in the alternative, some embodiments of the pump device may include a drive system that advances a piston rod to dispense medicine to the patient in a safe and energy efficient manner.