Ambulatory medical device with malfunction alert prioritization

Inventors

Rosinko, Michael J. • Patel, Himanshu • DAMIANO, Edward R. • EL-KHATIB, Firas H. • Lim, David Chi-Wai

Assignees

Beta Bionics Inc

Interested in licensing this patent?

MTEC can help explore whether this patent might be available for licensing for your application.

Publication Number

US-12743269-B2

Patent

Publication Date

2026-09-22

Expiration Date


Abstract

An ambulatory medical device can detect a device condition and determine if the device condition satisfies a set of normal operating parameters. If the normal operating parameters are not satisfied, the ambulatory medical device can determine if the device condition stratifies a set of minimum operating parameters. If the minimum operating parameters are satisfied, the ambulatory medical device can maintain a delivery of therapy to a subject and generate an alert based on the device condition.

Core Innovation

The disclosed glucose level control system detects a device condition that fails normal operating parameters, indicating a malfunction, while assessing whether different minimum operating parameters are satisfied. The normal operating parameters enable a set of therapy-related features, whereas minimum operating parameters enable a subset sufficient to permit dose generation. When satisfied, the system maintains generation of the dose output for administration of medicament to a subject at the same, reduced, or minimum rate.

The malfunction handling distinguishes conditions that permit continued therapy from those that do not permit dose generation. When minimum operating parameters are met, therapy is maintained and an alert is issued to the user. When minimum operating parameters are not met, therapy is stopped and a critical alert is issued. The system architecture encompasses manual and automated delivery modes, user-interface screens for therapy configuration, and an automatic dose-control signal generated from glucose-sensor data.

Claims Coverage

The independent claims consist of claim 1, directed to a glucose level control system, and claim 19, directed to a computer-implemented method, covering two inventive features.

Continued dose generation by a glucose level control system

A memory and hardware processor are configured to detect a device condition that fails normal operating parameters, determine that it satisfies different minimum operating parameters sufficient to permit dose generation and a subset of therapy-related features, and maintain dose output for administration of medicament to a subject at the same, a reduced, or a minimum rate of therapy administration.

Managing a non-critical malfunction by computer-implemented method

A computer-implemented method comprises detecting a device condition that fails normal operating parameters, determining that it satisfies different minimum operating parameters sufficient to permit dose generation, and maintaining dose output at the same, a reduced, or a minimum rate of therapy administration.

The independent claims cover a system and a computer-implemented method configured to maintain dose generation at the same, reduced, or minimum rate when a glucose level control system fails normal operating parameters but satisfies minimum operating parameters.

Stated Advantages

Not explicitly described in patent.

Documented Applications

A glucose level control system configured to generate a dose output for administration of medicament to a subject, including management of a non-critical malfunction when minimum operating parameters permit dose generation.

Glucose-control system functions include manual and automated delivery, meal-dose configuration, manual-bolus recording, and generation of an automatic dose-control signal using glucose-sensor data.

JOIN OUR MAILING LIST

Stay Connected with MTEC

Keep up with active and upcoming solicitations, MTEC news and other valuable information.