Devices and methods for initialization of drug delivery devices using measured analyte sensor information

Inventors

ZADE, AshutoshLee, Joon BokZheng, Yibin

Assignees

Insulet Corp

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Publication Number

US-12592306-B2

Patent

Publication Date

2026-03-31

Expiration Date


Abstract

Disclosed are processes and techniques implementable by a drug delivery system to maintain optimal drug delivery for a patient according to a treatment plan. The disclosed techniques enable a new drug delivery device that is exchanged for a previous drug delivery device to operate using analyte-based drug delivery control immediately during initialization instead of having to wait for a warm-up period. For example, a drug delivery device may include a processor and a memory storing instructions that, when executed by the processor, operate the drug delivery device to receive a present analyte measurement value from an analyte sensor during an initialization of the drug delivery device, receive backfill values measured by the analyte sensor prior to the initialization, calculate a dosage of a drug using the present analyte measurement value and the backfill values, and deliver the dosage of the drug. Other embodiments are described.

Core Innovation

A drug delivery device is operated by receiving a present analyte measurement value from an analyte sensor during an initialization associated with an exchange of the drug delivery device for a deactivated drug delivery device. During this initialization, the device also obtains prior context from the sensor in the form of at least one backfill value measured prior to the initialization.

The device calculates a dosage of a drug using the present analyte measurement value and the at least one backfill value, and then delivers the dosage. In some embodiments, the dosage calculation is based on an analyte concentration trend determined from the present analyte measurement value and the at least one backfill value.

Safety constraints are applied to the backfill values by determining whether the at least one backfill value satisfies a safety constraint, including a minimum number of backfill values and/or a correlation threshold with respect to the present analyte measurement value. Backfill values can be received from an external controller, and controller-side workflows include a deactivation indication and collecting sensor measurement values as backfill values for use during initialization of the drug delivery device.

Claims Coverage

The independent claims cover two aspects: a drug delivery device configured to use present analyte measurements together with prior sensor backfill values during initialization associated with exchanging for a deactivated device, and a corresponding computer-implemented method operating such a drug delivery device. Across the independent claims, the core inventive concept is the combination of present analyte measurement and at least one pre-initialization backfill value for dosage calculation and immediate delivery during initialization.

Initialization associated with device exchange for a deactivated device

Receive a present analyte measurement value from an analyte sensor during an initialization of the drug delivery device, wherein the initialization is associated with an exchange of the drug delivery device for a deactivated drug delivery device.

Backfill value measured prior to initialization

Receive at least one backfill value measured by the analyte sensor prior to the initialization.

Dosage calculation using present measurement and backfill values

Calculate a dosage of a drug using the present analyte measurement value and the at least one backfill value.

Delivering the calculated dosage

Deliver the dosage of the drug.

Safety constraint for backfill values

Determine whether at least one backfill value satisfies a safety constraint including a minimum number of backfill values and/or a correlation threshold of the backfill values relative to the present analyte measurement value.

Dosage calculation using an analyte concentration trend

Determine an analyte concentration trend from the present analyte measurement value and at least one backfill value, and calculate a dosage based on that trend.

Backfill sourced from an external controller

Receive at least one backfill value from an external controller.

Controller collects backfill values driven by a deactivation indication

Receive a deactivation indication from a first drug delivery device, connect to a sensor device in response to the deactivation indication, and collect sensor measurement values as backfill values.

Blood glucose implementation with insulin, glucagon, or glucagon-like peptide delivery

Use a blood glucose analyte measurement value and deliver insulin, glucagon, a glucagon-like peptide, or a combination of insulin, glucagon, and the glucagon-like peptide.

Overall, the claim set centers on initializing a drug delivery device after exchanging for a deactivated drug delivery device while receiving a present analyte measurement and at least one pre-initialization backfill value. It further defines how backfill values are validated via safety constraints, how dosage can be computed using an analyte concentration trend, and how backfill values can be obtained from an external controller or via controller-driven collection based on a deactivation indication.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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