Methods for operating mode transitions and related infusion devices and systems

• US 9,943,645 B2
• Filed: 12/04/2014
• Issued: 04/17/2018
• Est. Priority Date: 12/04/2014
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Monirabbasi, Salman, Lintereur, Louis J., Yan, Jin, Torres, Linda I.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): SWANSON, LEAH JENNINGS
• Application Number:
  US14/561,133
• Publication Number:
  US 20160158441A1
• Time in Patent Office: 1,230 Days
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/1424 Manually operated pumps
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• 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 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method involves operating an infusion device to deliver fluid to a user in accordance with a first operating mode of a plurality of operating modes, obtaining operational information pertaining to the first operating mode, and obtaining clinical information pertaining to the user. A destination operating mode of the plurality of operating modes is determined based at least in part on the operational information and the clinical information, and the infusion device is operated to deliver the fluid in accordance with the destination operating mode in a manner that is influenced by at least a portion of the operational information pertaining to the first operating mode.

Claims

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

operating the infusion device to deliver the fluid in an automated manner in accordance with a first operating mode of a plurality of different operating modes, each different operating mode of the plurality of different operating modes generating commands for delivering the fluid to the user in an automated manner in accordance with a different delivery control scheme associated therewith;

obtaining operational information pertaining to the operating of the infusion device in accordance with the first operating mode, the operational information including a current value for a refractory timer of the first operating mode;

obtaining clinical information pertaining to the user;

determining a destination operating mode of the plurality of different operating modes based at least in part on the operational information and the clinical information; and

transitioning operation of the infusion device from the first operating mode to the destination operating mode to deliver the fluid in an automated manner in accordance with the destination operating mode, wherein the destination operating mode is initialized using at least a portion of the operational information pertaining to the operating of the infusion device in accordance with the first operating mode by setting a second refractory timer of the destination operating mode to the current value for the refractory timer of the first operating mode.

2. The method of claim 1, wherein determining the destination operating mode comprises:

identifying a set of one or more possible operating modes of the plurality of different operating modes based at least in part on the operational information and the clinical information; and

selecting the destination operating mode from the set.

3. The method of claim 2, wherein identifying the set of one or more possible operating modes comprises excluding an operating mode of the plurality of different operating modes when the clinical information indicates the operating mode will violate a delivery control rule based on the operational information.

4. The method of claim 3, the clinical information including a current glucose measurement value and the operational information including a suspended delivery time for the first operating mode, wherein excluding the operating mode comprises excluding the operating mode when the current glucose measurement value indicates the operating mode will violate a suspension time limit based on the suspended delivery time.

5. The method of claim 3, the clinical information including a current glucose measurement value and an insulin delivered, wherein excluding the operating mode comprises excluding the operating mode when the current glucose measurement value indicates the operating mode will violate an insulin delivery limit.

6. The method of claim 2, wherein identifying the set of one or more possible operating modes comprises excluding an operating mode of the plurality of different operating modes when the clinical information indicates the operating mode will generate a user notification.

7. The method of claim 2, the operational information including a first number of user notifications generated by the first operating mode, wherein identifying the set of one or more possible operating modes comprises:

determining an operating mode of the plurality of different operating modes is likely to generate a second number of user notifications based on the clinical information; and

excluding the operating mode of the plurality of different operating modes from the set when a sum of the first number and the second number is greater than a threshold number of user notifications.

8. The method of claim 2, wherein identifying the set of one or more possible operating modes comprises excluding an operating mode of the plurality of different operating modes when the clinical information indicates the operating mode will automatically terminate.

9. The method of claim 2, wherein identifying the set of one or more possible operating modes comprises excluding an operating mode of the plurality of different operating modes in response to determining the operating mode is not viable for an expected duration based at least in part on the clinical information.

10. The method of claim 2, the portion of the operational information including sensor health information, wherein identifying the set of one or more possible operating modes comprises excluding an operating mode of the plurality of different operating modes based on the sensor health information.

11. The method of claim 1, the portion of the operational information including an insulin estimate and a refractory time, wherein transitioning operation of the infusion device comprises suspending delivery when the refractory time is less than a minimum refractory period in response to determining the insulin estimate is greater than a threshold amount.

12. An infusion device comprising:

a data storage element to maintain operational information pertaining to a first operating mode of a plurality of different operating modes and clinical information pertaining to a user the operational information including a current value for a refractory timer of the first operating mode;

a motor operable to deliver fluid to a body of the user, the fluid influencing a physiological condition of the user; and

a control system coupled to the motor and the data storage element to;

operate the motor to deliver the fluid in an automated manner in accordance with the first operating mode;

determine a destination operating mode of the plurality of different operating modes based at least in part on the operational information and the clinical information; and

transitioning from the first operating mode to the destination operating mode to operate the motor to deliver the fluid in an automated manner in accordance with the destination operating mode, wherein;

the destination operating mode is initialized using at least a portion of the operational information pertaining to the first operating mode by setting a second refractory timer of the destination operating mode to the current value for the refractory timer of the first operating mode; and

each different operating mode of the plurality of different operating modes generates commands for delivering the fluid to the user in an automated manner in accordance with a different delivery control scheme.

13. The infusion device of claim 12, further comprising a user interface to receive an indication to exit the first operating mode from the user, wherein the control system determines the destination operating mode and transitions from the first operating mode to the destination operating mode in response to the indication.

14. The infusion device of claim 12, wherein the control system includes a supervisory module to select the destination operating mode from among the plurality of different operating modes and provide the portion of the operational information from a first module associated with the first operating mode to a second module associated with the destination operating mode.

15. The infusion device of claim 12, wherein:

the data storage element maintains user preferences; and

the control system identifies a set of one or more possible operating modes of the plurality of different operating modes based at least in part on the operational information and the clinical information and selects the destination operating mode from the set based on the user preferences.

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

operating the infusion device to deliver the insulin in an automated manner in accordance with a first operating mode of a plurality of different operating modes, each different operating mode of the plurality of different operating modes generating commands for delivering the fluid to the user in an automated manner in accordance with a different delivery control scheme associated therewith;

obtaining operational information pertaining to the first operating mode, the operational information including a current value for a refractory timer of the first operating mode;

obtaining one or more glucose values for the user; and

in response to an indication to terminate the first operating mode;

determining a set of one or more possible operating modes from the plurality of different operating modes based at least in part on the one or more glucose values and the operational information;

selecting a destination operating mode from the set of one or more possible operating modes; and

transitioning the operating of the infusion device from the first operating mode to the destination operating mode to deliver the insulin in an automated manner in accordance with the destination operating mode, wherein the destination operating mode is initialized using at least a portion of the operational information pertaining to the first operating mode by setting a second refractory timer of the destination operating mode to the current value for the refractory timer of the first operating mode.

17. The method of claim 16, further comprising:

delivering the insulin in an automated manner in accordance with the destination operating mode at least until a value of the refractory timer of the destination operating mode is greater than or equal to a minimum refractory period.

18. The method of claim 16, the one or more glucose values including a predicted glucose value and the operational information including a current delivery suspension time for the first operating mode, wherein determining the set of one or more possible operating modes comprises:

determining an expected delivery suspension time for a predictive low glucose suspend operating mode of the plurality of different operating modes based at least in part on the predicted glucose value; and

excluding the predictive low glucose suspend operating mode from the set when a sum of the expected delivery suspension time and the current delivery suspension time is greater than a maximum delivery suspension threshold.

19. The method of claim 16, the one or more glucose values including a current glucose measurement value and the operational information including a current delivery suspension time for the first operating mode, wherein determining the set of one or more possible operating modes comprises:

determining an expected delivery suspension time for a low glucose suspend operating mode of the plurality of different operating modes based at least in part on the current glucose measurement value; and

excluding the low glucose suspend operating mode from the set when a sum of the expected delivery suspension time and the current delivery suspension time is greater than a maximum delivery suspension threshold.