Integrated insulin delivery system having safety features to prevent hypoglycemia
Inventors
Budiman, Erwin S. • Hayter, Gary A. • Crouther, Nathan C. • Taub, Marc B. • Harper, Wesley Scott • Wei, Charles
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12667667-B2
Publication Date
2026-06-30
Expiration Date
Abstract
Systems comprising: an analyte sensor for providing an analyte signal representative of an analyte level; a controller in data communication with the analyte sensor and programmed to provide a recommended medication dose based on the analyte level and a medication type, the controller comprising a user interface for inputting the medication type; and a model-based safety mechanism integrated with the controller for evaluating the recommended medication dose. Wherein the model-based safety mechanism overrides the recommended medication dose and provides a safety medication dose when the model-based safety mechanism detects a risk of insulin deprivation.
Core Innovation
An integrated insulin delivery system is disclosed that includes an insulin pump and an integrated control unit that issues delivery control signals to administer insulin to a user. The insulin pump includes a reservoir and a cannula and is configured to be worn externally on the user. The integrated control unit detects activation of a selectable button and transmits, in response, a delivery control signal to a processor.
While a current basal rate is suspended, the processor causes the pump to administer the dose of insulin as an instantaneous bolus based on the delivery control signal and then resumes the current basal rate after the instantaneous bolus is completed. The delivery control signal comprises a bolus amount to be administered with the instantaneous bolus, and delivery control signals can include bolus amount, bolus type, bolus delivery time, and bolus delivery interval.
The disclosed control approach is further refined using an analyte sensor and continuously monitored analyte data, including a continuous glucose monitoring (CGM) sensor. A model-based safety mechanism detects sensor signal anomalies, estimates sensor calibration accuracy using nominal sensor sensitivity versus measured sensor sensitivity, and modifies control parameters, including target glucose range limits and uncertainty/variance parameters, or requests recalibration, to maintain the analyte at a target level.
Additional safety-layer interventions are described using insulin on board (IOB) and model-based monitoring of low-insulin risk. The system can automatically reduce or inhibit delivery, including limiting correction boluses within an IOB safety limit, suspending basal during events and resuming after events/time/IOB, and terminating or reducing extended bolus and temporary basal when CGM indicates carbohydrate deficiency trends.
Claims Coverage
Independent claim clm-00001 covers a wearable externally worn insulin pump that suspends a current basal rate to deliver an instantaneous bolus based on a delivery control signal, then resumes basal after completion, with a selectable button on an integrated control unit triggering transmission of that delivery control signal including a bolus amount. Dependent claims further refine control to include CGM-based continuously monitored analyte data, anomaly detection and parameter adjustment, and delivery control signals that specify additional bolus timing/type/interval parameters.
Externally worn insulin pump with suspended basal and instantaneous bolus based on delivery control signal
An insulin pump configured to be worn externally on a user, including a reservoir and a cannula, where while a current basal rate is suspended the pump administers a dose of insulin as an instantaneous bolus based on a delivery control signal, and then resumes the current basal rate after the instantaneous bolus is completed.
Selectable button-triggered transmission of delivery control signal including bolus amount
An integrated control unit with a selectable button configured to detect activation of the selectable button and transmit, responsive to detecting activation, the delivery control signal to the processor, where the delivery control signal comprises a bolus amount to be administered with the instantaneous bolus.
Overall claim coverage centers on a user-activated instantaneous bolus delivered during basal suspension and followed by basal resumption, with delivery control signals carrying the bolus amount, and dependent refinements indicating CGM-based monitoring, anomaly detection with parameter adjustment, and more detailed bolus parameters.
Stated Advantages
Prevents insulin deprivation.
Prevents hypoglycemia.
Maintains the analyte at a target level using sensor anomaly detection and model-based safety mechanisms.
Limits correction boluses based on an IOB safety limit.
Documented Applications
Not explicitly described in patent.
Interested in licensing this patent?