Advance diagnosis of infusion device operating mode viability

• US 9,636,453 B2
• Filed: 12/04/2014
• Issued: 05/02/2017
• 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
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US14/561,128
• Publication Number:
  US 20160158438A1
• Time in Patent Office: 880 Days
• 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: 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 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/58 Means for facilitating use, e.g. by people with impaired vision
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• 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 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/16804 Flow controllers
• 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 40/40 : for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/60 : for the operation of medical equipment or devices

Abstract

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver fluid to a user in accordance with an operating mode involves obtaining operational information pertaining to one or more prior instances of the operating mode, obtaining status information pertaining to the infusion device, and determining a diagnosis time based at least in part on the operational information. The diagnosis time is prior to a subsequent instance of the operating mode. At the diagnosis time, the method automatically determines the viability of the subsequent instance of the operating mode based at least in part on the status information and automatically generates a notification indicative of a recommended action for the user based at least in part on the viability.

Claims

1. An infusion device comprising:

a user interface;

a memory to maintain status information pertaining to the infusion 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, the memory, and the user interface to;

operate the motor in a first instance to deliver the fluid in accordance with a closed-loop operating mode to regulate the physiological condition of the user to a target value using one or more control parameters, the one or more control parameters comprising one or more proportional-integral-derivative (PID) gain coefficients;

store operational information pertaining to the first instance of the closed-loop operating mode in the memory;

determine an expected start time for a subsequent instance of the closed-loop operating mode based at least in part on the operational information;

determine an expected duration for the subsequent instance of the closed-loop operating mode based at least in part on the operational information;

determine a diagnosis time prior to the expected start time;

at the diagnosis time prior to the expected start time, automatically determine viability of entering the subsequent instance of the closed-loop operating mode at the expected start time for the expected duration based at least in part on the status information by performing an algorithmic diagnostic check to determine availability of the closed-loop operating mode at the expected start time in the future for the subsequent instance of the closed-loop operating mode, wherein the algorithmic diagnostic check comprises determining whether the one or more control parameters can be calculated at the expected start time; and

automatically provide, via the user interface, a notification indicative of a recommended action based at least in part on the viability.

2. The infusion device of claim 1, wherein:

the status information includes measurement data pertaining to the physiological condition of the user; and

the control system determines the viability by determining whether the one or more control parameters for the closed-loop operating mode can be calculated in the future at the expected start time for the subsequent instance of the closed-loop operating mode based on the measurement data.

3. The infusion device of claim 2, wherein the recommended action comprises obtaining a new reference measurement for the physiological condition of the user.

4. The infusion device of claim 1, wherein the control system determines the viability by determining a physical capability of the infusion device implementing the closed-loop operating mode at the expected start time in the future for the subsequent instance of the closed-loop operating mode for the expected duration of the subsequent instance of the closed-loop operating mode.

5. The infusion device of claim 1, wherein the status information includes glucose measurement data for the user, wherein automatically determining the viability at the diagnosis time comprises the control system determining whether the one or more control parameters for the closed-loop operating mode can be calculated at the expected start time based on the glucose measurement data.

6. The infusion device of claim 5, wherein the notification comprises an indication to obtain a new reference glucose measurement for the user in response to the control system determining a control parameter of the one or more control parameters for the closed-loop operating mode cannot be calculated based on the glucose measurement data.

7. The infusion device of claim 1, wherein determining the diagnosis time comprises:

determining the diagnosis time as a buffer time prior to the expected start time.

8. The infusion device of claim 7, the operational information including start times for prior instances of the closed-loop operating mode, wherein the expected start time comprises an average of the start times.

9. The infusion device of claim 8, wherein the buffer time is based at least in part on the closed-loop operating mode of a plurality of operating modes supported by the infusion device.

10. The infusion device of claim 1, wherein:

the operational information includes durations for prior instances of the closed-loop operating mode; and

the expected duration comprises an average of the durations.

11. The infusion device of claim 10, wherein:

the operational information includes start times for prior instances of the closed-loop operating mode; and

the control system determines the diagnosis time as a buffer time before the expected start time for the subsequent instance of the closed-loop operating mode determined based on the start times.

12. The infusion device of claim 1, wherein the status information includes glucose measurement data for the user, wherein determining the viability of the subsequent instance of the closed-loop operating mode for the expected duration comprises the control system determining whether the one or more control parameters for the closed-loop operating mode calculated based on the glucose measurement data will be valid for an entirety of the expected duration.

13. The infusion device of claim 1, wherein the control system:

automatically performs a physical diagnostic check to determine a physical capability of the infusion device implementing the closed-loop operating mode for the expected duration; and

automatically generates the notification when the physical diagnostic check indicates an inability to implement the closed-loop operating mode for the expected duration based on the status information.

14. The infusion device of claim 1, wherein the control system:

automatically generates the notification when the algorithmic diagnostic check indicates unavailability of the closed-loop operating mode at the expected start time.

15. An infusion system comprising:

a user interface;

a sensing arrangement to obtain measurements of a physiological condition in a body of a user; and

an infusion device coupled to the user interface and the sensing arrangement, the infusion device being operable to;

deliver fluid influencing the physiological condition of the user to the body of the user based at least in part on the measurements in accordance with a closed-loop operating mode, the closed-loop operating mode regulating the physiological condition of the user to a target value using one or more control parameters, the one or more control parameters comprising one or more proportional-integral-derivative (PID) gain coefficients;

maintain status information pertaining to operation of the infusion device and operational information pertaining to one or more previous instances of the closed-loop operating mode;

determine an expected start time for a subsequent instance of the closed-loop operating mode based at least in part on the operational information;

determine an expected duration for the subsequent instance of the closed-loop operating mode based at least in part on the operational information;

determine a diagnosis time in advance of the expected start time for the subsequent instance of the closed-loop operating mode based at least in part on the operational information;

automatically determine, at the diagnosis time, viability of entering the subsequent instance of the closed-loop operating mode at the expected start time for the expected duration based at least in part on the status information by performing an algorithmic diagnostic check to determine availability of the closed-loop operating mode and whether the one or more control parameters can be calculated at the expected start time in the future for the subsequent instance of the closed-loop operating mode; and

automatically provide, via the user interface, a notification indicative of a recommended action based at least in part on the viability.