IP Library › Granted Patent US 12,431,229
Granted Patent B2
US 12,431,229 · App. 17/691,829 · Granted Sep 30, 2025

Medicament delivery device with an adjustable and piecewise analyte level cost component to address persistent positive analyte level excursions

Inventors: Joon Bok Lee (Acton, MA); Eric Benjamin (Cambridge, MA); Jason O'Connor (Acton, MA); Yibin Zheng (Hartland, WI)
Assignee: INSULET CORPORATION
G16H20/13A61M5/1723A61M2205/52A61M2230/201
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Quick Facts
Patent No.
US 12,431,229
App. No.
17/691,829
Granted
Sep 30, 2025
Kind
B2
Abstract

The exemplary embodiments may modify a glucose cost component of the cost function of the control loop of an insulin delivery device to compensate for persistent positive low level glucose excursions relative to a target glucose level. The exemplary embodiments may enable use of different glucose cost component functions for different glucose levels of the user. These glucose cost component functions may be employed in piecewise fashion with a different piece being applied for each respective range of glucose level values for the user. The final glucose cost function for calculating the glucose cost component may be a weighted combination of a piecewise glucose cost function and a weighted standard cost function (such as a quadratic function). The weights may reflect the magnitude and/or persistence of glucose excursions relative to a target glucose level.

Claims (39)

1. A diabetic treatment medicament delivery device, comprising:

a storage for storing medicament;

a needle or cannula for delivery of the medicament to the user;

a non-transitory storage medium for storing computer programming instructions for controlling operation of the diabetic treatment medicament delivery device;

a processor for executing the computer programming instructions to cause the processor to:

determine a selected basal diabetic treatment medicament dosage to be delivered by the diabetic treatment medicament delivery device to a user from among candidate basal diabetic treatment medicament dosages, the determining comprising determining the selected basal diabetic treatment medicament dosage based upon costs of the candidate basal diabetic treatment medicament dosages,

wherein the cost is determined by a cost function for determining a cost for each of the candidate basal diabetic treatment medicament dosages, where, for each of the candidate basal diabetic treatment medicament dosages, the cost function includes a glucose cost component that punishes glucose excursions relative to a target glucose level that are anticipated to be experienced by the user if the candidate basal diabetic treatment medicament dosage is delivered to the user by the diabetic treatment medicament delivery device and a medicament cost component that punishes deviations between the candidate basal diabetic treatment medicament dosage and a basal delivery medicament dosage, and

wherein the glucose cost component but not the medicament cost component varies in accordance with a first distribution function when the anticipated glucose excursions to be experienced by the user are in a first range and varies in accordance with a second distribution function when the anticipated glucose excursions to be experienced by the user are in a second range that differs from the first range; and

cause the determined basal diabetic treatment medicament dosage to be delivered from the storage of the diabetic treatment medicament delivery device to the user via the needle or cannula.

2. The diabetic treatment medicament delivery device of claim 1 , wherein the glucose cost component is a combination of a piecewise cost function and an additional cost function.

3. The diabetic medicament delivery device of claim 2 , wherein weights assigned to the piecewise cost function and the additional cost function in the glucose cost component depend on persistence and magnitude of glucose excursions experienced by the user.

4. The diabetic treatment medicament delivery device of claim 1 , wherein the first distribution function is a quadratic function.

5. The diabetic treatment medicament delivery device of claim 4 , wherein the second distribution function is a linear function.

6. The diabetic treatment medicament delivery device of claim 1 , wherein the second distribution function is a linear function.

7. The diabetic treatment medicament delivery device of claim 1 , wherein the first distribution function is an exponential function or a logarithmic function.

8. The diabetic treatment medicament delivery device of claim 1 , wherein the diabetic treatment medicament includes at least one of insulin, a glucagon-like peptide-1 (GLP-1) agonist, or pramlintide.

9. A medicament delivery device, comprising:

a storage for storing medicament;

a needle or cannula for delivery of the medicament to the user;

a non-transitory storage medium for storing computer programming instructions for controlling operation of the medicament delivery device;

a processor for executing the computer programming instructions as to cause the processor to:

determine a selected basal medicament dosage to be delivered by the medicament delivery device to a user from among candidate basal medicament dosages, the determining comprising determining the selected basal medicament dosage based upon costs of the candidate basal medicament dosages,

wherein the cost is determined by a cost function for determining a cost for each of the candidate basal medicament dosages, where, for each of the candidate basal medicament dosages, the cost function includes an analyte level component that punishes analyte level excursions relative to a target analyte level that are anticipated to be experienced by the user if the candidate basal medicament dosage is delivered to the user by the medicament delivery device and a medicament cost component that punishes deviations between the candidate medicament dosage and a basal delivery medicament dosage, and

wherein the analyte cost component varies in accordance with a first distribution function but not the medicament cost component when the anticipated analyte level excursions to be experienced by the user are in a first range and varies in accordance with a second distribution function when the anticipated analyte level excursions to be experienced by the user are in a second range that differs from the first range; and

cause the determined basal medicament dosage to be delivered from the storage of the medicament delivery device to the user via a needle or cannula.

10. The medicament delivery device of claim 9 , wherein the analyte cost component is a combination of a piecewise cost function and an additional cost function.

11. The medicament delivery device of claim 10 , wherein weights assigned to the piecewise cost function and the additional cost function in the analyte level cost component depend on persistence and magnitude of analyte excursions experienced by the user.

12. The medicament delivery device of claim 9 , wherein the first distribution function is one of a quadratic function, an exponential function, a linear function or a logarithmic function.

13. A method performed by a processor of a medicament delivery device for controlling basal medicament deliveries by the medicament delivery device, comprising:

with the processor of the medicament delivery device, determining a medicament cost for a candidate basal medicament dosage for delivery to a user by the medicament delivery device;

with the processor, determining an analyte level cost for the candidate basal medicament dosage, the analyte level cost comprising:

where an analyte level of the user in a prediction horizon if the candidate basal medicament dosage is delivered to the user is within a specified range of a target analyte level of the user, a value produced by a linear function of a deviation between the analyte level of the user in the prediction horizon and the target analyte level of the user, and

where a analyte level of the user in the prediction horizon if the candidate basal medicament dosage is delivered to the user is outside a specified range of a target analyte level of the user, a value produced by a quadratic function of a deviation between the analyte level in the prediction horizon and the target analyte level of the user;

with the processor, determining a cost for the candidate basal medicament dosage using the medicament cost and the analyte level cost;

with the processor, based on the cost, deciding to deliver the candidate basal medicament dosage.

14. The method of claim 13 , wherein the medicament is insulin.

15. The method of claim 13 , further comprising weighting the analyte cost in the determining of the cost for the candidate basal medicament dosage.

16. The method of claim 15 , further comprising weighting the medicament cost in the determining of the cost for the candidate basal medicament dosage.

17. The method of claim 15 , wherein the cost for the candidate basal medicament dosage is the sum of the weighted medicament cost and the weighted analyte cost.

Assignments (2)
SECURITY AGREEMENT SUPPLEMENT Recorded Dec 1, 2022
From: INSULET CORPORATION
To: MORGAN STANLEY SENIOR FUNDING, INC., AS COLLATERAL AGENT
Reel/Frame 062035/0785 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 29, 2022
From: LEE, JOON BOK; BENJAMIN, ERIC; O'CONNOR, JASON; ZHENG, YIBIN
To: INSULET CORPORATION
Reel/Frame 059712/0066 →
Continuity (2)
Provisional Application 63158918 · Mar 10, 2021
Related Publication 20220293234A1 · Sep 15, 2022
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