IP Library › Granted Patent US 12,268,844
Granted Patent B2
US 12,268,844 · App. 17/513,487 · Granted Apr 8, 2025

Integrated insulin delivery system having safety features to prevent hypoglycemia

Inventors: Erwin S. Budiman (Fremont, CA); Gary A. Hayter (Oakland, CA)
Assignee: Abbott Diabetes Care Inc.
A61M5/1723A61B5/14532A61B5/1495A61B5/4839G16H20/17A61B2562/0295A61M2005/14208A61M2005/14296A61M2205/3569A61M2205/52A61M2230/201
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Quick Facts
Patent No.
US 12,268,844
App. No.
17/513,487
Filed
Oct 28, 2021
Granted
Apr 8, 2025
Kind
B2
Art Unit
3783
USPC
604/66
Abstract

Systems for the delivery of insulin to a patient, the system comprising: a continuous glucose sensor configured to provide a glucose level signal representative of sensed glucose; an insulin delivery device configured to deliver insulin in response to delivery control signals at a basal rate and as a bolus; and a controller programmed to receive the sensor glucose level signal and to provide a delivery control signal to an insulin delivery device to suspend a basal delivery rate during the provision of a bolus delivery and to automatically resume a preprogrammed basal delivery rate after a selected event.

Claims (39)

1. A system, comprising:

a glucose monitor comprising:

a glucose sensor comprising a first portion configured to be arranged above a skin surface of a user, and a second portion configured to be arranged below the skin surface and in contact with an interstitial fluid of the user to provide signals representative of glucose levels, and

a transmitter in communication with the glucose sensor, wherein the transmitter is configured to wirelessly transmit the signals representative of glucose levels; and

an insulin pump controller in data communication with the glucose monitor to receive the signals representative of glucose levels, wherein the insulin pump controller is configured to provide control signals to an insulin pump, and wherein the insulin pump controller comprises a processor and a memory that stores programming configured to cause the processor to:

determine a difference between a factory sensitivity of the glucose sensor and a sensitivity of the glucose sensor in operation, and

provide a control signal to the insulin pump to terminate insulin delivery in response to determining that the difference between the factory sensitivity of the glucose sensor and the sensitivity of the glucose sensor in operation exceeds a predetermined threshold.

2. The system of claim 1 , wherein the insulin pump controller is a semi-closed loop controller.

3. The system of claim 1 , wherein the insulin pump controller is a fully closed loop controller.

4. The system of claim 1 , further comprising an electronic device in wireless communication with the glucose monitor, wherein the electronic device is configured to communicate with an insulin pump.

5. The system of claim 4 , wherein the electronic device comprises the insulin pump controller.

6. The system of claim 1 , further comprising an insulin pump in communication with the insulin pump controller and with the glucose monitor, wherein the insulin pump is configured to administer insulin to the user based on the control signals from the insulin pump controller.

7. The system of claim 6 , wherein the insulin pump comprises the insulin pump controller.

8. The system of claim 6 , further comprising an electronic device in communication with the glucose monitor and with the insulin pump, wherein the electronic device comprises a display configured to display information corresponding to the glucose levels.

9. The system of claim 1 , wherein the programming is further configured to cause the processor to prompt a user to enter a blood glucose measurement in response to the difference between the factory sensitivity and the sensitivity of the glucose sensor in operation exceeding a second predetermined threshold.

10. A system, comprising:

a glucose monitor comprising:

a glucose sensor comprising a first portion configured to be arranged above a skin surface of a user, and a second portion configured to be arranged below the skin surface and in contact with an interstitial fluid of the user to provide signals representative of glucose levels, and

a transmitter in communication with the glucose sensor, wherein the transmitter is configured to wirelessly transmit the signals representative of glucose levels; and an insulin pump controller in data communication with the glucose monitor to receive the signals representative of glucose levels, wherein the insulin pump controller is configured to provide control signals to an insulin pump, and wherein the insulin pump controller comprises a processor and a memory that stores programming configured to cause the processor to:

determine a difference between a factory sensitivity of the glucose sensor and a sensitivity of the glucose sensor in operation,

adjust a calibration correction factor to be applied to the signals representative of glucose levels when the difference between the factory sensitivity and the sensitivity of the glucose sensor in operation exceeds a predetermined threshold, and

communicate a control signal to the insulin pump to terminate insulin delivery based on the difference between the factory sensitivity and the sensitivity of the glucose sensor in operation.

11. The system of claim 10 , wherein the insulin pump controller is a semi-closed loop controller.

12. The system of claim 10 , wherein the insulin pump controller is a fully closed loop controller.

13. The system of claim 10 , further comprising an electronic device in wireless communication with the glucose monitor, wherein the electronic device is configured to communicate with an insulin pump.

14. The system of claim 13 , wherein the electronic device comprises the insulin pump controller.

15. The system of claim 10 , further comprising an insulin pump in communication with the insulin pump controller and with the glucose monitor, wherein the insulin pump is configured to administer insulin to the user based on the control signals from the insulin pump controller.

16. The system of claim 15 , wherein the insulin pump comprises the insulin pump controller.

17. The system of claim 15 , further comprising an electronic device in communication with the glucose monitor and with the insulin pump, wherein the electronic device comprises a display configured to display information corresponding to the glucose levels.

18. A method, comprising:

providing signals representative of glucose levels by a glucose sensor of a glucose monitor, wherein a first portion of the glucose sensor is configured to be placed above a skin surface of a user, and wherein a second portion of the glucose sensor is configured to be placed below the skin surface and in contact with an interstitial fluid of the user;

transmitting, via a wireless communication protocol, the signals representative of glucose levels to an insulin pump controller in data communication with the glucose monitor, wherein the insulin pump controller is configured to provide control signals to an insulin pump;

determining, by the insulin pump controller, a difference between a factory sensitivity of the glucose sensor and a sensitivity of the glucose sensor in operation;

adjusting a calibration correction factor to be applied to the signals representative of glucose levels based on the difference between the factory sensitivity and the sensitivity of the glucose sensor in operation; and

communicating a control signal to the insulin pump to terminate insulin delivery based on the difference between the factory sensitivity and the sensitivity of the glucose sensor in operation.

19. The method of claim 18 , further comprising:

determining estimated glucose levels based on the signals representative of the glucose levels and the calibration correction factor.

20. The method of claim 18 , further comprising:

communicating, from the insulin pump controller to an insulin pump in communication with the insulin pump controller, a control signal to terminate insulin delivery when the difference between the factory sensitivity and the sensitivity of the glucose sensor in operation exceeds a predetermined threshold.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 28, 2021
From: BUDIMAN, ERWIN S.; HAYTER, GARY A.; CROUTHER, NATHAN; TAUB, MARC B.; HARPER, WESLEY SCOTT; WEI, CHARLES
To: ABBOTT DIABETES CARE INC.
Reel/Frame 057952/0563 →
Continuity (7)
Continuation 16808816 · Mar 4, 2020
Continuation 16169350 · Oct 24, 2018
Continuation 14077181 · Nov 11, 2013
Division 13601944 · Aug 31, 2012
Division 12785104 · May 21, 2010
Provisional Application 61180627 · May 22, 2009
Related Publication 20220047812A1 · Feb 17, 2022
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