INFUSION DEVICES AND RELATED METHODS FOR THERAPY RECOMMENDATIONS

• US 20160339175A1
• Filed: 05/20/2015
• Published: 11/24/2016
• Est. Priority Date: 05/20/2015
• Status: Active Application

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Yan, Jin, Naylor, Ross H., Monirabbasi, Salman, Palerm, Cesar C., Lintereur, Louis J., Sokolovskyy, Dmytro Y.
• Application Number:
  US14/717,902
• Publication Number:
  US 20160339175A1
• 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 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2230/00 Measuring parameters of the user
• 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: G16H 40/67 for remote operation

Abstract

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver fluid to a body of a user involves autonomously operating the infusion device to deliver a variable rate of infusion of the fluid in a first operating mode, determining a residual amount of active fluid in the body of the user based at least in part on the variable rate of infusion delivered by the infusion device in the first operating mode, and in response to identifying a change in operating mode from the first operating mode, generating a user notification based at least in part on the residual amount of active fluid. The residual amount represents infused fluid that exceeds a nominal amount corresponding to a reference rate of infusion for maintaining a physiological condition in the body of the user at a desired level.

Claims

1. A method of operating an infusion device to deliver fluid to a body of a user, the method comprising:

autonomously operating the infusion device to deliver a variable rate of infusion of the fluid in a first operating mode;

determining a residual amount of active fluid in the body of the user based at least in part on the variable rate of infusion delivered by the infusion device in the first operating mode; and

in response to identifying a change in operating mode from the first operating mode, generating a user notification based at least in part on the residual amount of active fluid.

2. The method of claim 1, wherein determining the residual amount of active fluid comprises:

determining a total amount of active fluid in the body of the user based at least in part on the variable rate of infusion;

determining a nominal amount of active fluid in the body of the user based at least in part on a reference rate of infusion; and

determining the residual amount based on a difference between the total amount and the nominal amount.

3. The method of claim 2, wherein determining the nominal amount comprises determining the reference rate of infusion based on a total daily dose of the fluid for the user.

4. The method of claim 2, wherein:

determining the total amount of active fluid comprises iteratively determining a first amount of active fluid in a pharmacokinetics compartment based on the variable rate of infusion and a first set of variables; and

determining the nominal amount of active fluid comprises iteratively determining a second amount of active fluid in the pharmacokinetics compartment based on the reference rate of infusion and the first set of variables.

5. The method of claim 4, wherein:

determining the total amount of active fluid comprises subtracting a first cumulative amount of active fluid in the pharmacokinetics compartment determined based on the variable rate of infusion from a second cumulative amount of fluid delivered based on the variable rate of infusion; and

determining the nominal amount of active fluid comprises subtracting a third cumulative amount of active fluid in the pharmacokinetics compartment determined based on the reference rate of infusion from a fourth cumulative amount of fluid corresponding to the reference rate of infusion.

6. The method of claim 4, wherein:

iteratively determining the first amount of active fluid comprises;

determining an active insulin amount for a plasma compartment based on the variable rate of infusion, a preceding instance of the active insulin amount for the plasma compartment, and a first subset of the first set of variables; and

determining the first amount of active fluid for an effect-site compartment based at least in part on the preceding instance of the active insulin amount for the plasma compartment, a preceding instance of the first amount of active fluid for the effect-site compartment, and a second subset of the first set of variables; and

iteratively determining the second amount of active fluid comprises;

determining a second active insulin amount for the plasma compartment based on the reference rate of infusion, a preceding instance of the second active insulin amount for the plasma compartment, and the first subset of the first set of variables; and

determining the second amount of active fluid for the effect-site compartment based at least in part on the preceding instance of the second active insulin amount for the plasma compartment, a preceding instance of the second amount for the effect-site compartment, and the second subset of the first set of variables.

7. The method of claim 1, wherein autonomously operating the infusion device to deliver the variable rate of infusion of the fluid in the first operating mode comprises:

obtaining measurement values for a physiological condition in the body of the user, the physiological condition being influenced by the fluid delivered by the infusion device;

determining dosage commands for operating a motor of the infusion device based on differences between the measurement values and a reference value; and

automatically operating the motor in accordance with the dosage commands to provide the variable rate of infusion.

8. The method of claim 1, wherein generating the user notification comprises displaying a graphical representation of the residual amount of active fluid.

9. The method of claim 1, wherein determining the residual amount of active fluid comprises determining the residual amount of active fluid based at least in part on the variable rate of infusion and a total daily dose of the fluid associated with the user.

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

operating the infusion device in a closed-loop operating mode to autonomously deliver a variable rate of infusion to the body based on a difference between glucose measurements from the body of the user and a reference glucose value;

recursively determining a total active insulin amount based at least in part on the variable rate of infusion;

recursively determining a nominal active insulin amount based at least in part on a constant rate of infusion; and

upon exiting the closed-loop operating mode;

determining a residual active insulin amount based on a difference between the total active insulin amount and the nominal active insulin amount; and

displaying a graphical user notification influenced by the residual active insulin amount.

11. The method of claim 10, further comprising determining the constant rate of infusion based on a total daily dose of insulin for the user.

12. The method of claim 10, wherein recursively determining the total active insulin amount comprises:

iteratively determining first active insulin amounts for a plasma compartment based at least in part on the variable rate of infusion and a preceding active insulin amount of the first active insulin amounts for the plasma compartment;

iteratively determining second active insulin amounts for an effect-site compartment based at least in part on the preceding active insulin amount for the plasma compartment and a preceding active insulin amount of the second active insulin amounts for the effect-site compartment; and

determining a first difference between a cumulative amount of insulin delivered based on the variable rate of infusion and a sum of the second active insulin amounts.

13. The method of claim 12, wherein recursively determining the nominal active insulin amount comprises:

iteratively determining third active insulin amounts for the plasma compartment based at least in part on the constant rate of infusion and a preceding active insulin amount of the third active insulin amounts for the plasma compartment;

iteratively determining fourth active insulin amounts for the effect-site compartment based at least in part on the preceding active insulin amount of the third active insulin amounts for the plasma compartment and a preceding active insulin amount of the fourth active insulin amounts for the effect-site compartment; and

determining a second difference between a second cumulative amount of insulin delivered based on the constant rate of infusion and a second sum of the fourth active insulin amounts.

14. The method of claim 13, wherein determining the residual active insulin amount comprises subtracting the second difference from the first difference.

15. The method of claim 10, further comprising determining a recommended remedial action based on the residual active insulin amount, wherein displaying the graphical user notification comprises displaying the recommended remedial action.

16. The method of claim 10, wherein displaying the graphical user notification comprises displaying the residual active insulin amount.

17. An infusion system comprising:

a user interface;

an infusion device including a motor operable to deliver fluid to a body of a user and a control system coupled to the motor, the fluid influencing a physiological condition of the user; and

a sensing arrangement to obtain measurement values for the physiological condition from the body of the user, wherein the control system is coupled to the user interface and the sensing arrangement to autonomously operate the motor to deliver a variable basal rate of infusion based on the measurement values, determine a residual amount of the fluid that is active in the body of the user based at least in part on the variable basal rate of infusion, and provide a user notification on the user interface influenced by the residual amount.

18. The infusion system of claim 17, wherein the residual amount comprises a difference between a total amount of active fluid in the body of the user corresponding to the variable basal rate of infusion and a nominal amount of active fluid in the body of the user corresponding to a reference basal rate of infusion.

19. The infusion system of claim 18, wherein:

the infusion device includes a data storage element maintaining a total daily dose for the user; and

the control system is coupled to the data storage element and determines the reference basal rate of infusion based on the total daily dose.

20. The infusion system of claim 17, wherein:

the infusion device includes a data storage element maintaining a total daily dose for the user; and

the control system is coupled to the data storage element and determines the residual amount based at least in part on the total daily dose and the variable basal rate of infusion.