Granted Patent B2

US 12,653,949 · App. 17/812,817 · Granted Jun 16, 2026

Inventor: Rangarajan Narayanaswami (Weston, MA)

Assignee: INSULET CORPORATION

A61M5/1723A61M2230/06A61M2230/50A61M2230/63A61M2230/65

Abstract

Claims (80)

1 . A wearable drug delivery system, comprising:

one or more sensors operable to measure a physiological condition of a user;

a processor communicatively coupled to the one or more sensors;

a pump mechanism coupled to the processor and to a drug container, wherein the drug container is operable to store a liquid drug;

a memory coupled to the processor, the memory including programming code;

the processor, when executing the programming code, operable to:

receive measurement values from the one or more sensors;

evaluate each of the received measurement values against a respective threshold measurement value corresponding to the one or more sensors;

determine based on a result of the evaluation of each of the received measurement values whether the user is experiencing stress;

in response to the determination the user is experiencing stress, estimate a degree of stress;

based on the degree of stress, modify a pending dosage of a liquid drug to be delivered, a time of delivery of the pending dosage, or both; and

expel the liquid drug according to the modified pending dosage, the modified time of delivery of the pending dosage, or both.

2 . The wearable drug delivery system of claim 1 , wherein the one or more sensors includes a skin temperature sensor, a heart rate sensor, a skin conductance sensor, or an accelerometer.

3 . The wearable drug delivery system of claim 2 , wherein the processor, prior to evaluating each of the received measurement values against the respective threshold measurement value corresponding to the one or more sensors, is further configured to:

identify a physical activity state based on detection of an elevated heart rate of the user, a change in skin conductance of the user, or a change in body temperature of the user.

4 . The wearable drug delivery system of claim 3 , wherein the processor is further operable to:

in response to the physical activity state indicating participation in physical activity by the user, exclude a period of time corresponding to the physical activity state from the determination of whether the user is experiencing stress.

5 . The wearable drug delivery system of claim 2 , wherein prior to evaluating each of the received measurement values against a respective threshold measurement value corresponding to the one or more sensors, the processor is operable to:

determine a physical activity state of the user based on an input from the accelerometer, wherein an attribute of an accelerometer signal received as the input is used as a marker of physical activity of the user.

6 . The wearable drug delivery system of claim 5 , wherein the processor is further operable to:

in response to the physical activity state indicating participation in physical activity by the user, exclude a period of time corresponding to the physical activity state from evaluation for stress.

7 . The wearable drug delivery system of claim 2 , wherein evaluating each of the received measurement values against the respective threshold measurement value corresponding to the one or more sensors, the processor is further operable to:

determine if a skin temperature measurement received from the skin temperature sensor is lower than an earlier skin temperature measurement; and

in response to the skin temperature measurement being lower than the earlier skin temperature measurement, generate a signal indicating that the skin temperature measurement is lower than the earlier skin temperature measurement and a number of degrees lower.

8 . The wearable drug delivery system of claim 2 , wherein the processor is further operable to:

receive the measurement values from the skin temperature sensor by sampling the skin temperature measurement output by the skin temperature sensor at a high frequency to obtain a plurality of skin temperature measurements;

determine a minimum skin temperature measurement from among the plurality of skin temperature measurements;

determine a maximum skin temperature measurement from among the plurality of skin temperature measurements;

determine a standard deviation of the plurality of skin temperature measurements; and

use the determined minimum skin temperature, the determined maximum skin temperature, and the determined standard deviation when estimating the degree of stress.

9 . The wearable drug delivery system of claim 1 , wherein the processor is further operable to:

in response to receiving the inputs from a respective sensor of the one or more sensors, select a group level model from a plurality of group level models, wherein each respective group level model of the group level models enables modeling an individual stress load of a person; and

in response to applying the inputs to the selected group level model, generate an individualized stress load model for the user.

10 . The wearable drug delivery system of claim 9 , wherein the processor, when determining whether the user is experiencing stress, is further operable to:

apply inputs to the individualized stress load model;

process an output for the individualized stress load model to determine whether the user is experiencing stress; and

in response to a determination that the user experiencing stress, process the output to provide the estimated degree of stress.

11 . The wearable drug delivery system of claim 10 , wherein the processor when modifying the pending dosage is operable to:

modify an amount of a liquid drug to be delivered as a basal dosage via basal delivery, modify a time for delivery of the basal dosage, modify an amount of a liquid drug to be delivered as a bolus dosage via a bolus delivery, modify a frequency of delivery of a basal dosage, or modify a time of delivery the bolus dosage.

12 . The wearable drug delivery system of claim 9 , wherein the processor is further operable to:

use based on an output from the individualized stress load model in the estimating of the degree of stress the user is experiencing; and

in response to a determination of the degree of stress the user is experiencing, modifying a drug delivery treatment plan.

13 . The wearable drug delivery system of claim 1 , wherein the processor, when receiving measurement values from the one or more sensors is operable to:

receive a measure heart rate variability;

compare the measured heart rate variability to a heart rate variability threshold; and

in response to the measured heart rate variability exceeding the heart rate variability threshold, generate an indication that the user is experiencing stress.

14 . A method comprising:

obtaining a respective measurement value from one or more sensors, wherein each sensor of the one or more sensors obtains data related to a physiological condition of a user;

evaluating each obtained respective measurement value against a respective threshold measurement value corresponding to the one or more sensors;

determining, based on a result of the evaluation of each of the obtained respective measurement values, a degree of stress the user is experiencing;

in response to a determination of the degree of stress the user is experiencing, modifying an imminent dosage of a liquid drug to be delivered, a time of delivery of the imminent dosage, or both; and

expelling the liquid drug according to the modified imminent dosage, the modified time of delivery of the imminent dosage, or both.

15 . The method of claim 14 , wherein modifying the imminent dosage of the liquid drug to be delivered, the time of delivery of the imminent dosage, or both, further comprises:

evaluating the degree of stress with reference to results of a machine learning algorithm trained using user responses to multiple degrees of stress; and

determining, based on a result of the evaluating, at least one of:

a stress-modified dosage that is an amount of the liquid drug that is different from an amount of the imminent dosage of the liquid drug to be delivered, or

a first stress-modified delivery time that is different from an imminent delivery time of a next dosage of the liquid drug, or

a combination of the stress-modified dosage and the first stress-modified delivery time, or

a combination of the stress-modified dosage and a second stress-modified delivery time, wherein the second stress-modified delivery time is based on the stress-modified dosage and is different from the first stress-modified delivery time.

16 . The method of claim 14 , wherein modifying an imminent dosage of the liquid drug to be delivered, a time of delivery of the imminent dosage, or both, further comprises:

modifying an amount of a liquid drug to be delivered as a basal dosage via basal delivery,

modifying a time for delivery of the basal dosage,

modifying a frequency of delivery of a basal dosage,

modifying a time of delivery of a bolus dosage that was the imminent dosage of the liquid drug,

modifying an amount of a liquid drug to be delivered as a modified bolus dosage via a bolus delivery, or

modifying a time of delivery of the modified bolus dosage.

17 . The method of claim 16 , wherein evaluating each obtained respective measurement value against the respective threshold measurement value corresponding to the one or more sensors further comprises:

comparing a measured heart rate variability signal obtained from a heart rate sensor to a heart rate variability threshold; and

in response to the measured heart rate variability exceeding the heart rate variability threshold, generate an indication that the user is experiencing stress.

18 . The method of claim 14 , wherein obtaining a respective measurement value from the one or more sensors, wherein each sensor of the one or more sensors obtains data related to a physiological condition of the user, further comprises:

obtaining a measure of heart rate variability.

19 . The method of claim 18 , further comprising:

evaluating the respective measurement of the heart rate variability by comparing the measured heart rate variability to a heart rate variability threshold; and

in response to the measured heart rate variability exceeding the heart rate variability threshold, using a result of the comparing when estimating the degree of stress, the user is experiencing.

20 . A non-transitory computer-readable storage medium, the computer-readable storage medium including instructions that when executed by a processor, cause the processor to:

obtain a respective measurement value from one or more sensors, wherein each sensor of the one or more sensors obtains data related to a physiological condition of a user;

evaluate each obtained respective measurement value against a respective threshold measurement value corresponding to the one or more sensors;

determine based on a result of the evaluation of each of the obtained respective measurement values a degree of stress the user is experiencing;

in response to the determination of the degree of stress the user is experiencing, modify an imminent dosage of a liquid drug to be delivered, a time of delivery of the imminent dosage, or both; and

cause the liquid drug to be expelled according to the modified imminent dosage, the modified time of delivery of the imminent dosage, or both.

Assignments (2)

Continuity (2)

References Cited (400)