Granted Patent B2

US 12,490,920 · App. 17/345,511 · Granted Dec 9, 2025

Inventors: Ellis Garai (Woodland Hills, CA); Sarkis D. Aroyan (Northridge, CA); Margaret R. Miller (Northridge, CA); Melissa Tsang (Sherman Oaks, CA)

Assignee: MEDTRONIC MINIMED, INC.

A61B5/14532A61B5/1468A61B2560/0247A61B2562/12

Abstract

Claims (60)

1 . A method for initializing a glucose sensor, the method comprising:

determining a current profile for current flowing through a working electrode of the glucose sensor based on one or more parameters related to manufacturing of the glucose sensor or environmental conditions of the glucose sensor that are present in vivo, wherein the current profile comprises a slope of the current over time;

determining one or more parameters of a sequence of voltage pulses of an initialization sequence based on the current profile, wherein the one or more parameters comprise a voltage amplitude of the sequence of voltage pulses based at least in part on the slope of the current;

executing the initialization sequence by applying the sequence of voltage pulses to the working electrode of the glucose sensor at least partially inserted subcutaneously in a patient; and

reporting glucose levels in a patient after the initialization sequence.

2 . The method of claim 1 , wherein a duration or a duty cycle of the voltage pulses in the sequence of voltage pulses is based on the one or more parameters related to manufacturing the glucose sensor, and

wherein the one or more parameters related to manufacturing the glucose sensor include one or more of a platinum surface area ratio, a glucose oxidase activity, a glucose oxidase thickness, an amount of an intermediate layer between an enzyme layer and a glucose limiting membrane, a glucose limiting membrane thickness, or a glucose limiting membrane permeability.

3 . The method of claim 1 , wherein the initialization sequence is based on the environmental conditions of the glucose sensor that are present in vivo, the method further comprising:

measuring the current through the working electrode, wherein the working electrode is configured to sense glucose levels;

calculating the slope of the current over time; and

adjusting a voltage at the working electrode based on the slope.

4 . The method of claim 3 , wherein adjusting the voltage at the electrode based on the slope comprises:

raising the voltage at the electrode in the case the slope is higher than a first threshold; and

lowering the voltage at the electrode in the case the slope is lower than a second threshold.

5 . The method of claim 3 , wherein calculating the slope of the current over time comprises:

calculating a moving average of the slope of the current over a window of time.

6 . The method of claim 1 , wherein the initialization sequence is based on environmental conditions of the glucose sensor that are present in vivo, the method further comprising:

measuring one or more of an electro chemical impedance spectroscopy of a working electrode, a voltage at a counter electrode, or a current through a background electrode;

calculating a change of one or more of the electro chemical impedance spectroscopy of the working electrode, the voltage at the counter electrode, or the current through a background electrode over time; and

adjusting a voltage at the working electrode based on the change of one or more of the electro chemical impedance spectroscopy of the working electrode, the voltage at the counter electrode, or the current through a background electrode over time.

7 . The method of claim 1 , further comprising:

determining the initialization sequence from a plurality of initialization sequences based on the environmental conditions of the glucose sensor that are present in vivo.

8 . The method of claim 7 , wherein the plurality of initialization sequences vary in terms of voltage curves, starting points of the voltage curves, ending points of the voltage curves, or durations of the voltage curves.

9 . The method of claim 1 , wherein executing the initialization sequence for the glucose sensor comprises:

executing the initialization sequence for the glucose sensor for a period of time, wherein the initialization sequence is based on the one or more of parameters related to manufacturing the glucose sensor; and

adjusting the initialization sequence, after the period of time, based on the environmental conditions of the glucose sensor that are present in vivo.

10 . A device for initializing a glucose sensor, the device comprising:

a memory; and

one or more processors implemented in circuitry and in communication with the memory, the one or more processors configured to:

determine a current profile for current flowing through a working electrode of the glucose sensor based on one or more parameters related to manufacturing of the glucose sensor or environmental conditions of the glucose sensor that are present in vivo, wherein the current profile comprises a slope of the current over time;

determine one or more parameters of a sequence of voltage pulses of an initialization sequence based on the current profile, wherein the one or more parameters comprise a voltage amplitude of the sequence of voltage pulses based at least in part on the slope of the current;

execute the initialization sequence by applying the sequence of voltage pulses to the working electrode of the glucose sensor at least partially inserted subcutaneously in a patient; and

report glucose levels in a patient after the initialization sequence.

11 . The device of claim 10 , wherein the duration, the voltage, or the duty cycle of the initialization sequence is based on the one or more parameters related to manufacturing the glucose sensor, and

wherein the one or more parameters related to manufacturing the glucose sensor include one or more of a platinum surface area ratio, a glucose oxidase activity, a glucose oxidase thickness, an amount of an intermediate layer between an enzyme layer and a glucose limiting membrane, a glucose limiting membrane thickness, or a glucose limiting membrane permeability.

12 . The device of claim 10 , wherein the initialization sequence is based on the environmental conditions of the glucose sensor that are present in vivo, and wherein the one or more processors are further configured to:

measure the current through the working electrode, wherein the working electrode is configured to sense glucose levels;

calculate the slope of the current over time; and

adjust a voltage at the working electrode based on the slope.

13 . The device of claim 12 , wherein to adjust the voltage at the electrode based on the slope, the one or more processors are further configured to:

raise the voltage at the electrode in the case the slope is higher than a first threshold; and

lower the voltage at the electrode in the case the slope is lower than a second threshold.

14 . The device of claim 12 , wherein to calculate the slope of the current over time, the one or more processors are further configured to:

calculate a moving average of the slope of the current over a window of time.

15 . The device of claim 10 , wherein the initialization sequence is based on environmental conditions of the glucose sensor that are present in vivo, and wherein the one or more processors are further configured to:

measure one or more of an electro chemical impedance spectroscopy of a working electrode, a voltage at a counter electrode, or a current through a background electrode;

calculate a change of one or more of the electro chemical impedance spectroscopy of the working electrode, the voltage at the counter electrode, or the current through a background electrode over time; and

adjust a voltage at the working electrode based on the change of one or more of the electro chemical impedance spectroscopy of the working electrode, the voltage at the counter electrode, or the current through a background electrode over time.

16 . The device of claim 10 , wherein the one or more processors are further configured to:

determine the initialization sequence from a plurality of initialization sequences based on the environmental conditions of the glucose sensor that are present in vivo.

17 . The device of claim 16 , wherein the plurality of initialization sequences vary in terms of voltage curves, starting points of the voltage curves, ending points of the voltage curves, or durations of the voltage curves.

18 . The device of claim 10 , wherein to execute the initialization sequence for the glucose sensor, the one or more processors are further configured to:

execute the initialization sequence for the glucose sensor for a period of time, wherein the initialization sequence is based on the one or more of parameters related to manufacturing the glucose sensor; and

adjust the initialization sequence, after the period of time, based on the environmental conditions of the glucose sensor that are present in vivo.

19 . The device of claim 10 , wherein the device is a continuous glucose monitor that includes the glucose sensor.

20 . A non-transitory computer-readable storage medium having stored thereon instructions that, when executed, configure a processor to:

determine a current profile for current flowing through a working electrode of a glucose sensor based on one or more parameters related to manufacturing of the glucose sensor or environmental conditions of the glucose sensor that are present in vivo, wherein the current profile comprises a measured change in the current over time;

determine one or more parameters of a sequence of voltage pulses of an initialization sequence based on the current profile, wherein the one or more parameters comprise a voltage amplitude of the sequence of voltage pulses based on the measured change in the current;

execute the initialization sequence by applying the sequence of voltage pulses to the working electrode of the glucose sensor at least partially inserted subcutaneously in a patient; and

report glucose levels in a patient after the initialization sequence.

Assignments (3)

Continuity (1)

References Cited (13)