PREDICTIVE INFUSION DEVICE OPERATIONS AND RELATED METHODS AND SYSTEMS

• US 20150165117A1
• Filed: 04/24/2014
• Published: 06/18/2015
• Est. Priority Date: 12/12/2013
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Palerm, Cesar C., Lintereur, Louis J., Monirabbasi, Salman, Holtzclaw, Kris R., Desborough, Lane
• Granted Patent: US 10,105,488 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a user involves determining a current value for a physiological condition of the user influenced by the fluid violates a first threshold value, determining a predicted value for the physiological condition of the user violates a second threshold value, and automatically altering operation of the infusion device to modify delivery of the fluid to the user after determining the predicted value violates the second threshold value when the current value violates the first threshold value.

Claims

1. A method of operating an infusion device operable to deliver fluid to a user, the fluid influencing a physiological condition of the user, the method comprising:

determining a current value for the physiological condition of the user violates a first threshold value;

determining a predicted value for the physiological condition of the user violates a second threshold value; and

after determining the predicted value violates the second threshold value when the current value violates the first threshold value, automatically altering operation of the infusion device to modify delivery of the fluid to the user.

2. The method of claim 1, wherein automatically altering operation of the infusion device comprises automatically disabling operation of the infusion device to deliver the fluid to the user when the current value is less than the first threshold value and the predicted value is less than the second threshold value.

3. The method of claim 2, further comprising automatically enabling operation of the infusion device to deliver the fluid to the user after automatically disabling operation of the infusion device when the current value is greater than a third threshold value and the predicted value is greater than a fourth threshold value.

4. The method of claim 3, further comprising verifying a refractory time period has elapsed after enabling operation of the infusion device before subsequently automatically disabling operation of the infusion device to deliver the fluid when the current value is less than the first threshold value and the predicted value is less than the second threshold value.

5. The method of claim 4, further comprising determining the refractory time period based on responsiveness of the user.

6. The method of claim 3, further comprising verifying a minimum suspension time period has elapsed after automatically disabling operation of the infusion device prior to automatically enabling operation of the infusion device.

7. The method of claim 6, further comprising verifying a refractory time period has elapsed after automatically enabling operation of the infusion device before subsequently automatically disabling operation of the infusion device to deliver the fluid when the current value is less than the first threshold value and the predicted value is less than the second threshold value.

8. The method of claim 2, further comprising:

determining a current insulin on board for the user; and

automatically enabling operation of the infusion device to deliver the fluid to the user after automatically disabling operation of the infusion device when the current insulin on board is less than a threshold insulin on board.

9. The method of claim 1, further comprising:

obtaining a suspend protection threshold value via a user interface; and

determining the second threshold value based at least in part on the suspend protection threshold value, wherein;

the first threshold value is greater than the second threshold value; and

automatically altering operation of the infusion device comprises automatically disabling operation of the infusion device to deliver the fluid to the user when the current value is less than the first threshold value and the predicted value is less than the second threshold value.

10. The method of claim 9, further comprising:

determining a resume enable threshold value based at least in part on the suspend protection threshold value; and

automatically enabling operation of the infusion device to deliver the fluid to the user after automatically disabling operation of the infusion device when the current value is greater than the resume enable threshold value and the predicted value is greater than a predictive resume threshold value, wherein the predictive resume threshold value is greater than the resume enable threshold value.

11. The method of claim 10, wherein the resume enable threshold value is equal to the second threshold value.

12. The method of claim 1, wherein automatically altering operation of the infusion device comprises automatically enabling operation of the infusion device to deliver the fluid to the user when the current value is greater than the first threshold value and the predicted value is greater than the second threshold value.

13. The method of claim 1, automatically altering operation of the infusion device comprising automatically transitioning the infusion device from a first mode to a second mode, wherein the method further comprises verifying a minimum time period for operating the infusion device in the first mode has elapsed prior to automatically transitioning the infusion device to the second mode.

14. A computer-readable medium having computer-executable instructions stored thereon that, when executed by a processing system associated with the infusion device, cause the processing system to perform the method of claim 1.

15. An infusion device comprising:

a motor operable to deliver fluid to a body of a user; and

a control module coupled to the motor to automatically suspend operation of the motor in response to determining a current measurement value for a physiological condition in the body of the user is less than a suspend enable threshold value and a predicted value for the physiological condition of the user is less than a predictive suspend threshold value.

16. The infusion device of claim 15, wherein the control module automatically enables operation of the motor in response to determining the current measurement value is greater than a resume enable threshold value and the predicted value is greater than a predictive enable threshold value.

17. The infusion device of claim 15, further comprising a user interface to receive a suspend protection threshold value, wherein the control module is coupled to the user interface to obtain the suspend protection threshold value and determine the predictive suspend threshold value based at least in part on the suspend protection threshold value.

18. An infusion system comprising:

a sensing arrangement to obtain the current measurement value for the physiological condition from the body of the user; and

the infusion device of claim 15, wherein the control module is communicatively coupled to the sensing arrangement to receive the current measurement value from the sensing arrangement.

19. A method of operating an infusion device operable to deliver insulin to a user, the method comprising:

determining a current glucose measurement value for the user is less than a suspend enable threshold value;

determining a predicted glucose value for the user is less than a predictive suspend threshold value; and

automatically transitioning the infusion device from an insulin delivery mode to a suspend delivery mode after determining the current glucose measurement value is less than the suspend enable threshold value and the predicted glucose value is less than the predictive suspend threshold value.

20. The method of claim 19, further comprising:

obtaining a suspend protection threshold value;

determining the suspend enable threshold value, the predictive suspend threshold value, a resume enable threshold value, and a predictive resume threshold value based at least in part on the suspend protection threshold value; and

automatically transitioning the infusion device from the suspend delivery mode to the insulin delivery mode after determining the current glucose measurement value is greater than the resume enable threshold value and the predicted glucose value is greater than the predictive resume threshold value, wherein;

the predictive resume threshold value is greater than or equal to the resume enable threshold value;

the resume enable threshold value is greater than or equal to the predictive suspend threshold value; and

the suspend enable threshold value is greater than the predictive suspend threshold value.