Infusion devices and related methods and systems for automatic alert clearing

• US 10,265,031 B2
• Filed: 12/19/2014
• Issued: 04/23/2019
• Est. Priority Date: 12/19/2014
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Palerm, Cesar C., Myers, Jeffrey C.
• Primary Examiner(s): Riggs, II, Larry D
• Application Number:
  US14/578,170
• Publication Number:
  US 20160174911A1
• Time in Patent Office: 1,586 Days
• Field of Search: None
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of alerting a user associated with an infusion device delivering fluid to the body of the user involves obtaining a first value for a physiological condition being influenced by the fluid, determining a metric corresponding to a future physiological condition of the user based at least in part on the first value, and automatically generating a first alert based on the metric. After automatically generating the first alert, the method continues by obtaining a second value for the physiological condition of the user and automatically clearing the first alert based at least in part on the second value.

Claims

1. A method of preemptively alerting a user, the method comprising:

obtaining, by a control module from a sensing arrangement, a first measurement value for a physiological condition in a body of the user at a first time, the physiological condition being influenced by a fluid delivered by an infusion device;

determining, by the control module, a homeostasis metric indicative of an expected state of the physiological condition of the user in the future based at least in part on the first measurement value and a first amount of active fluid in the body of the user at the first time;

automatically generating a preemptive alert on a display device coupled to the control module based on the homeostasis metric; and

after automatically generating the preemptive alert;

obtaining, by the control module from the sensing arrangement, a second measurement value for the physiological condition of the user at a second time after the first time;

determining, by the control module, an updated value for the homeostasis metric based at least in part on the second measurement value and a second amount of active fluid in the body of the user at the second time; and

automatically removing, by the control module, the preemptive alert from the display device based at least in part on the updated value for the homeostasis metric.

2. The method of claim 1, wherein:

automatically generating the preemptive alert based on the metric comprises generating the preemptive alert when the value for the homeostasis metric is greater than an alert threshold; and

automatically removing the preemptive alert comprises automatically removing the preemptive alert when the second value is less than the alert threshold.

3. The method of claim 1, the fluid comprising insulin influencing a glucose level in a body of the user, wherein:

obtaining the first measurement value comprises obtaining a first glucose measurement value from the body of the user at the first time;

determining the homeostasis metric comprises determining a predicted glucose value based at least in part on the first glucose measurement value and the first amount of insulin on board at the first time;

automatically generating the preemptive alert comprises automatically providing the preemptive alert when the predicted glucose value violates a first alerting threshold;

obtaining the second measurement value comprises obtaining a second glucose measurement value from the body of the user at the second time after the first time;

determining the updated value for the homeostasis metric comprises determining an updated predicted glucose value based at least in part on the second glucose measurement value and the second amount of insulin on board at the second time; and

automatically removing the preemptive alert comprises automatically removing the preemptive alert when the updated predicted glucose value does not violate the first alerting threshold.

4. The method of claim 1, the fluid comprising insulin influencing a glucose level in a body of the user, wherein:

obtaining the first measurement value comprises obtaining a first glucose measurement value from the body of the user at the first time;

obtaining the second measurement value comprises obtaining a second glucose measurement value from the body of the user at the second time after the first time; and

automatically removing the preemptive alert comprises automatically removing the preemptive alert when the second glucose measurement value violates an alert threshold.

5. The method of claim 4, wherein:

determining the homeostasis metric comprises determining a recommended correction bolus amount based on the first glucose measurement value; and

automatically removing the preemptive alert comprises automatically removing the preemptive alert when the second glucose measurement value is greater than a hyperglycemic alert threshold.

6. The method of claim 5, wherein automatically removing the preemptive alert comprises automatically providing a hyperglycemic alert in lieu of the preemptive alert when the second glucose measurement value is greater than the hyperglycemic alert threshold.

7. The method of claim 4, wherein:

determining the homeostasis metric comprises determining an estimated excess insulin amount based on the first glucose measurement value; and

automatically removing the preemptive alert comprises automatically removing the preemptive alert when the second glucose measurement value is less than a hypoglycemic alert threshold.

8. The method of claim 7, wherein automatically removing the preemptive alert comprises automatically providing a hypoglycemic alert in lieu of the preemptive alert when the second glucose measurement value is less than the hypoglycemic alert threshold.

9. The method of claim 1, further comprising operating the infusion device operable to deliver a dosage of the fluid to the user based at least in part on the first measurement value, wherein obtaining the second measurement value comprises obtaining the second measurement value after operating the infusion device to deliver the dosage.

10. A non-transitory computer-readable medium having computer-executable instructions stored thereon that, when executed by the control module associated with the infusion device, cause the control module to perform the method of claim 1.

15. The method of claim 1, further comprising:

determining, by the control module, a first amount of anticipated deliveries of the fluid at the first time; and

determining, by the control module, a second amount of anticipated deliveries of the fluid at the second time, wherein;

determining the homeostasis metric comprises determining the homeostasis metric corresponding to the future physiological condition of the user based at least in part on the first measurement value, the first amount of active fluid in the body of the user at the first time, and the first amount of anticipated deliveries of the fluid at the first time; and

determining the updated value for the homeostasis metric comprises determining the updated value for the homeostasis metric corresponding to the future physiological condition of the user based at least in part on the second measurement value, the second amount of active fluid in the body of the user at the second time, and the second amount of anticipated deliveries of the fluid at the second time.

16. The method of claim 1, wherein:

determining the homeostasis metric comprises determining the homeostasis metric corresponding to the future physiological condition of the user based at least in part on the first measurement value, the first amount of active fluid in the body of the user at the first time, and a target value for the physiological condition; and

determining the updated value for the homeostasis metric comprises determining the updated value for the homeostasis metric corresponding to the future physiological condition of the user based at least in part on the second measurement value, the second amount of active fluid in the body of the user at the second time, and the target value.

17. The method of claim 1, wherein:

determining the homeostasis metric comprises determining the homeostasis metric corresponding to the future physiological condition of the user based at least in part on the first measurement value, the first amount of active fluid in the body of the user at the first time, and a first insulin sensitivity factor at the first time; and

determining the updated value for the homeostasis metric comprises determining the updated value for the homeostasis metric corresponding to the future physiological condition of the user based at least in part on the second measurement value, the second amount of active fluid in the body of the user at the second time, and a second insulin sensitivity factor at the second time.

19. The method of claim 1, wherein:

the expected state comprises one of a hyperglycemic condition or a hypoglycemic condition;

automatically generating the preemptive alert comprises automatically generating the preemptive alert in advance of the one of the hyperglycemic condition or the hypoglycemic condition; and

automatically removing the preemptive alert comprises automatically removing the preemptive alert without any affirmative action by the user.

20. The method of claim 19, wherein automatically generating the preemptive alert in advance of the hyperglycemic condition or the hypoglycemic condition comprises automatically generating the preemptive alert in advance of the hyperglycemic condition or the hypoglycemic condition when at least one of a current glucose level for the user and a predicted future glucose level for the user is within an acceptable range.

11. An infusion device comprising:

a display device;

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

a control system coupled to the motor and the display device to;

operate the motor to deliver the fluid;

obtain a first measurement value for the physiological condition in the body of the user at a first time;

determine a homeostasis metric indicative of an expected state of the physiological condition of the user in the future based at least in part on the first measurement value and a first amount of active fluid at the first time;

automatically generate a preemptive alert via the display device based on the homeostasis metric;

obtain a second measurement value for the physiological condition of the user after automatically generating the preemptive alert at a second time after the first time;

determine an updated value for the homeostasis metric corresponding to the future physiological condition of the user based at least in part on the second measurement value and a second amount of active fluid in the body of the user at the second time; and

automatically remove the preemptive alert from the display device based at least in part on the updated value for the homeostasis metric.

12. The infusion device of claim 11, wherein the control system obtains the first measurement value and the second measurement value from a sensing arrangement, the sensing arrangement sensing the physiological condition in the body of the user.

13. The infusion device of claim 11, the fluid comprising insulin influencing a glucose level in the body of the user, wherein the homeostasis metric comprises a predicted value for the glucose level in the body of the user.

18. The infusion device of claim 11, wherein the control system determines the homeostasis metric based at least in part on the first measurement value, the first amount of active fluid at the first time and a first pending delivery commands for operating the motor at the first time, and determines the updated value for the homeostasis metric based at least in part on the second measurement value, the second amount of active fluid at the second time and second pending delivery commands for operating the motor at the second time.

14. An infusion system comprising:

a display device;

an infusion device operable to deliver fluid to a body of a user, the fluid influencing a physiological condition of the user;

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

a control system coupled to the display device and the sensing arrangement to obtain a first measurement value for the physiological condition from the sensing arrangement at a first time, determine a homeostasis metric corresponding to a future physiological condition of the user based at least in part on the first measurement value and a first amount of active fluid at the first time, automatically generate a preemptive alert via the display device based on the homeostasis metric, and after automatically generating the preemptive alert, obtain a second measurement value for the physiological condition from the sensing arrangement at a second time after the first time, determine an updated value for the homeostasis metric corresponding to the future physiological condition of the user based at least in part on the second measurement value and a second amount of active fluid in the body of the user at the second time, and automatically remove the preemptive alert from the display device based at least in part on the updated value for the homeostasis metric.