Field update of an ambulatory infusion pump system

• US 10,456,524 B2
• Filed: 02/19/2018
• Issued: 10/29/2019
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Ludolph, Don
• Primary Examiner(s): Dao, Thuy
• Application Number:
  US15/898,781
• Publication Number:
  US 20180169330A1
• Time in Patent Office: 617 Days
• 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 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• 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 2205/60 with identification means
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• 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: G06F 8/65 Updates security arrangements therefor G06F21/57
• 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 40/63 for local operation
• CPC Class Codes: G16H 40/67 : for remote operation

Abstract

Portable or ambulatory infusion devices and systems capable of remotely updating an ambulatory fluid delivery device include safety protocols that verify the status of the ambulatory fluid delivery device before and after a field update of software. Methods of accomplishing the same field update of software are also described.

Claims

1. A method performed by software executable instructions on a hardware processor for remotely updating software on a control device configured to effect operation of an ambulatory infusion pump, comprising:

at a central computing system, obtaining data relating to operation of the ambulatory infusion pump;

by the central computing system, verifying compatibility of the control device with a software update including verifying that a device model of the control device is compatible with the software update;

verifying that a user wishes to proceed with the software update;

receiving, at the central computer system, a password required for execution of the software update; and

verifying, by the central computer system, the received password;

transmitting the software update from the central computing system to the control device;

receiving confirmation at the central computing system that the software update has occurred; and

verifying that a safe condition exists for operation of the ambulatory infusion pump by the control device after the software update.

2. The method of claim 1, wherein the control device is a portable computing device.

3. The method of claim 1, wherein the control device is a dedicated handheld remote control.

4. The method of claim 1, further comprising verifying that a safe condition for the software update exists.

5. The method of claim 4, wherein verifying that a safe condition for the software update exists includes transmitting a verification of a safe condition from the control device to the central computing system.

6. The method of claim 4, where a safe condition for the software update comprises one or more of:

the ambulatory infusion pump not currently administering a medicament,

the ambulatory infusion pump not being attached to a patient, and

a medicament reservoir of the ambulatory infusion pump not being in fluid communication with the patient.

7. The method of claim 4, where a safe condition for the software update comprises a patient not being able to accidentally receive unintentional amounts of the medicament.

8. The method of claim 1, wherein verifying a safe condition exists for operation of the ambulatory infusion pump by the control device after the software update comprises one or more of:

verifying an ability of the ambulatory infusion pump to dispense one or more medicaments;

verifying an ability of the ambulatory infusion pump to update a device history log; and

verifying an ability of the ambulatory infusion pump to accept sensor data to influence medicament dosing.

9. The method of claim 1, further comprising verifying, at the central computer system, an absence of error messages relating to operation of the ambulatory infusion pump.

10. The method of claim 1, wherein verifying that a user wishes to proceed with the software update includes receiving from the control device an indication of user input accepting a message pertaining to the software update.

11. The method of claim 1, wherein verifying compatibility of the control device with a software update including verifying a memory capacity of the control device.

12. The method of claim 1, further comprising verifying that the pump performs as intended after the software update.

13. A method for remotely updating software on a control device configured to effect operation of an ambulatory infusion pump, comprising:

facilitating the transmission of data relating to operation of the ambulatory infusion pump to a central computer system;

transmitting information for verifying compatibility of the control device with a software update to the central computer system including information for verification of a device model of the control device;

transmitting a verification that a user wishes to proceed with the software update to the central computer system;

transmitting to the central computer system a password required for execution of the software update;

receiving the software update from the central computer system;

installing the software update on the control device;

transmitting confirmation to the central computer system that the software update has occurred; and

transmitting information for verifying that a safe condition exists for operation of the ambulatory infusion pump by the control device after the software update.

14. The method of claim 13, wherein the control device is a portable computing device.

15. The method of claim 13, wherein the control device is a dedicated handheld remote control.

16. The method of claim 13, further comprising transmitting information for verifying that a safe condition for the software update exists.

17. The method of claim 16, wherein transmitting information for verifying that a safe condition for the software update exists includes transmitting the information from the control device to the central computer system.

18. The method of claim 16, where a safe condition for the software update comprises one or more of:

the ambulatory infusion pump not currently administering a medicament,

the ambulatory infusion pump not being attached to a patient, and

a medicament reservoir of the ambulatory infusion pump not being in fluid communication with the patient.

19. The method of claim 16, where a safe condition for the software update comprises a patient not being able to accidentally receive unintentional amounts of the medicament.

20. The method of claim 13, wherein transmitting information for verifying a safe condition exists for operation of the ambulatory infusion pump by the control device after the software update comprises transmitting information relating to one or more of:

verifying an ability of the ambulatory infusion pump to dispense one or more medicaments;

verifying an ability of the ambulatory infusion pump to update a device history log; and

verifying an ability of the ambulatory infusion pump to accept sensor data to influence medicament dosing.

21. The method of claim 13, further comprising transmitting information to the central computer system for verifying an absence of error messages relating to operation of the ambulatory infusion pump.

22. The method of claim 13, wherein verifying that a user wishes to proceed with the software update includes receiving user input accepting a message pertaining to the software update at the control device.

23. The method of claim 13, wherein transmitting information for verifying compatibility of the control device with a software update to the central computer system includes transmitting information for verifying a memory capacity of the control device.

24. The method of claim 13, further comprising verifying that the pump performs as intended after the software update.