Advance diagnosis of infusion device operating mode viability

• US 10,363,366 B2
• Filed: 03/22/2017
• Issued: 07/30/2019
• 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:
  US15/466,614
• Publication Number:
  US 20170189617A1
• Time in Patent Office: 860 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. A method of operating an infusion device to deliver fluid to a user in accordance with an operating mode of a plurality of operating modes supported by the infusion device, the method comprising:

obtaining, by a control system associated with the infusion device, operational information pertaining to one or more prior instances of the operating mode;

obtaining, by the control system, status information pertaining to the infusion device;

determining, by the control system, an expected start time for a subsequent instance of the operating mode based on the operational information;

determining, by the control system, a buffer time based at least in part on the operating mode of the plurality of operating modes;

determining, by the control system, a diagnosis time as the buffer time prior to the expected start time, the diagnosis time being prior to the subsequent instance of the operating mode;

automatically determining, by the control system, viability of the subsequent instance of the operating mode based at least in part on the status information at the diagnosis time; and

automatically generating, by the control system, a notification indicative of a recommended action for the user based at least in part on the viability.

2. The method of claim 1, the status information including glucose measurement data for the user, wherein automatically determining the viability at the diagnosis time comprises determining whether one or more control parameters for the operating mode can be calculated based on the glucose measurement data.

3. The method of claim 2, wherein automatically generating the notification comprises automatically providing an indication to obtain a new reference glucose measurement for the user in response to determining a control parameter of the one or more control parameters for the operating mode cannot be calculated based on the glucose measurement data.

4. The method of claim 1, the operational information including start times for the respective one or more prior instances of the operating mode, wherein determining the expected start time comprises averaging the start times for the respective one or more prior instances.

5. The method of claim 1, further comprising determining an expected duration for the subsequent instance of the operating mode, wherein automatically determining the viability comprises determining the viability of the subsequent instance of the operating mode for the expected duration based at least in part on the status information.

6. The method of claim 5, the operational information including durations for the respective one or more prior instances of the operating mode, wherein determining the expected duration comprises averaging the durations for the respective one or more prior instances.

7. The method of claim 6, the operational information including start times for the respective one or more prior instances of the operating mode, wherein determining the diagnosis time comprises:

determining the expected start time for the subsequent instance of the operating mode based on the start times for the respective one or more prior instances of the operating mode.

8. The method of claim 5, the status information including glucose measurement data for the user, wherein determining the viability of the subsequent instance of the operating mode for the expected duration comprises determining whether one or more control parameters for the operating mode calculated based on the glucose measurement data will be valid for an entirety of the expected duration.

9. A method of operating an infusion device to deliver fluid to a user in accordance with an operating mode of a plurality of operating modes supported by the infusion device, the method comprising:

obtaining, by a control module of the infusion device, operational information pertaining to one or more prior instances of the operating mode;

obtaining, by the control module, status information pertaining to the infusion device;

determining, by the control module, an expected start time for a subsequent instance of the operating mode based at least in part on the operational information;

determining, by the control module, a buffer time based at least in part on the operating mode of the plurality of operating modes;

determining, by the control module, a diagnosis time based at least in part on the operational information, the diagnosis time being the buffer time prior to the expected start time;

automatically performing, by the control module, an algorithmic diagnostic check to determine an availability of the operating mode at the expected start time based at least in part on the status information at the diagnosis time; and

automatically providing, by the control module, a notification indicative of a recommended action for the user when the algorithmic diagnostic check indicates unavailability at the diagnosis time.

10. The method of claim 9, the operating mode comprising a closed-loop operating mode for regulating a physiological condition of the user to a target value based on measurements of the physiological condition in a body of the user and one or more control parameters, wherein automatically performing the algorithmic diagnostic check comprises determining whether the one or more control parameters can be calculated at the expected start time.

11. The method of claim 9, the status information including glucose measurement data for the user, wherein:

automatically performing the algorithmic diagnostic check comprises determining whether one or more control parameters for the operating mode can be calculated at the expected start time based on the glucose measurement data.

12. The method of claim 11, wherein the notification comprises an indication to obtain a new reference glucose measurement for the user in response to determining a control parameter of the one or more control parameters for the operating mode cannot be calculated at the expected start time based on the glucose measurement data.

13. The method of claim 9, further comprising determining, by the control module, an expected duration of the subsequent instance of the operating mode based at least in part on the operational information, wherein:

the status information includes glucose measurement data for the user; and

automatically performing the algorithmic diagnostic check comprises determining whether one or more control parameters for the operating mode calculated based on the glucose measurement data will be valid for an entirety of the expected duration of the subsequent instance of the operating mode.

14. A method of operating an infusion device to deliver fluid to a user in accordance with a closed-loop operating mode for regulating a physiological condition of the user to a target value based on measurements of the physiological condition in a body of the user and one or more control parameters, the method comprising:

obtaining, by a control module of the infusion device, operational information pertaining to one or more prior instances of the closed-loop operating mode;

obtaining, by the control module, status information pertaining to the infusion device;

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

determining, by the control module, a diagnosis time based at least in part on the operational information, the diagnosis time being prior to the expected start time;

automatically performing, by the control module, an algorithmic diagnostic check to determine an availability of the closed-loop operating mode at the expected start time based at least in part on the status information at the diagnosis time to determine whether one or more proportional-integral-derivative (PID) gain coefficients can be calculated at the expected start time; and

automatically providing, by the control module, a notification indicative of a recommended action for the user when the algorithmic diagnostic check indicates unavailability at the diagnosis time.