Field update of an ambulatory infusion pump system

• US 9,242,043 B2
• Filed: 03/15/2013
• Issued: 01/26/2016
• 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:
  US13/838,084
• Publication Number:
  US 20140276571A1
• Time in Patent Office: 1,047 Days
• US Class Current: 1/1
• 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 for remotely updating software on an ambulatory fluid delivery device comprising:

from a central computing system, interrogating the ambulatory fluid delivery device and obtaining data comprising a device history log;

by the central computing system, verifying that the ambulatory fluid delivery device has not exhibited unusual performance and the ambulatory fluid delivery device is compatible with a software update including both verifying a memory capacity of the ambulatory fluid delivery device and confirming that a model of the ambulatory fluid delivery device is compatible with the software update, and verifying that a user of the ambulatory fluid delivery device wishes to update software on the ambulatory fluid delivery device;

sending the software update from the central computing system to the ambulatory fluid delivery device;

verifying that the ambulatory fluid delivery device is in a safe condition for the software update;

performing the software update on the ambulatory fluid delivery device; and

verifying that the ambulatory fluid delivery device in is a safe condition to perform as intended after the software update comprising the ability to update the device history log.

2. The method of claim 1, further comprising prompting the user to configure the ambulatory fluid delivery device for regular operation.

3. The method of claim 2, wherein regular operation comprises the administration of one or more medications to a patient.

4. The method of claim 1, wherein the software update is only performed after verifying that the ambulatory fluid delivery device is in a safe condition for update.

5. The method of claim 1, wherein a safe condition for update comprises not currently administering a medicament, not being attached to a patient, a liquid medicament repository not being in fluid communication with the patient, not containing any medicament, or any combination thereof.

6. The method of claim 1, wherein verifying that the ambulatory fluid delivery device is in a safe condition to perform as intended further comprises:

verifying the ability to dispense one or more medicaments;

verifying the ability of the ambulatory fluid delivery device to accept sensor data to influence medicament dosing;

verifying the ability of the ambulatory fluid delivery device to repeatedly and safely perform dispensing actions;

or

any combination thereof.

7. The method of claim 1, wherein verifying that the ambulatory fluid delivery device has not exhibited unusual performance includes verifying an absence of error messages.

8. The method of claim 1, wherein verifying that a user of the ambulatory fluid delivery device wishes to update software on the ambulatory fluid delivery device comprises:

presenting the user with a message and accepting user input via a user interface on the ambulatory fluid delivery device;

presenting the user with a message via a remote control and accepting user input via the remote control or via a user interface on the ambulatory fluid delivery device;

presenting the user with a message via an external computing device and accepting user input via the external computing device or via a user interface on the ambulatory fluid delivery device;

or

any combination thereof.

9. A method for remotely providing a software update for an ambulatory fluid delivery device comprising:

from a central computing system, interrogating the ambulatory fluid delivery device and obtaining data comprising device history logs;

by the central computing system, verifying that the ambulatory fluid delivery device has not exhibited unusual performance and the ambulatory fluid delivery device is compatible with a software update including both verifying a memory capacity of the ambulatory fluid delivery device and confirming that a model of the ambulatory fluid delivery device is compatible with the software update, and verifying that a user of the ambulatory fluid delivery device wishes to update software on the ambulatory fluid delivery device;

sending the software update from the central computing system to the ambulatory fluid delivery device;

from the central computing system, confirming that the ambulatory fluid delivery device is in a safe condition for update;

receiving confirmation on the central computing system that the software update has occurred on the ambulatory fluid delivery device; and

on the central computing system, receiving information verifying that the ambulatory fluid delivery device in is a safe condition to perform as intended after the software update comprising the ability to update the device history log.

10. The method of claim 9, further comprising prompting the user to configure the ambulatory fluid delivery device for regular operation.

11. The method of claim 10, wherein regular operation comprises the administration of one or more medications to a patient.

12. The method of claim 9, wherein the software update is only performed after verifying that the ambulatory fluid delivery device is in a safe condition for update.

13. The method of claim 12, wherein a safe condition for update comprises not currently administering a medicament, not being attached to a patient, a liquid medicament repository not being in fluid communication with the patient, not containing any medicament, or any combination thereof.

14. The method of claim 9, wherein verifying that the ambulatory fluid delivery device is in a safe condition to perform as intended further comprises:

verifying the ability to dispense one or more medicaments;

verifying the ability of the ambulatory fluid delivery device to accept sensor data to influence medicament dosing;

verifying the ability of the ambulatory fluid delivery device to repeatedly and safely perform dispensing actions;

or

any combination thereof.

15. The method of claim 9, wherein verifying that the ambulatory fluid delivery device has not exhibited unusual performance includes verifying an absence of error messages.

16. The method of claim 9, wherein verifying that a user of the ambulatory fluid delivery device wishes to update software on the ambulatory fluid delivery device comprises:

presenting the user with a message and accepting user input via a user interface on the ambulatory fluid delivery device;

presenting the user with a message via a remote control and accepting user input via the remote control or via a user interface on the ambulatory fluid delivery device;

presenting the user with a message via an external computing device and accepting user input via the external computing device or via a user interface on the ambulatory fluid delivery device;

or

any combination thereof.

17. A method for remotely performing a software update on an ambulatory fluid delivery device comprising:

in response to an interrogation from a central computing system, sending data comprising device history logs to the central computing system;

receiving confirmation from the central computing system that the ambulatory fluid delivery device has not exhibited unusual performance and the ambulatory fluid delivery device is compatible with the software update including both a verification of the memory capacity of the ambulatory fluid delivery device and a confirmation that the model of the ambulatory fluid delivery device is compatible with the software update, and that a user of the ambulatory fluid delivery device wishes to update software on the ambulatory fluid delivery device;

receiving the software update from the central computing system on the ambulatory fluid delivery device;

confirming that the ambulatory fluid delivery device is in a safe condition for update via user input;

sending confirmation from the ambulatory fluid delivery device that the software update has occurred on the ambulatory fluid delivery device; and

sending information from the ambulatory fluid delivery device verifying that the ambulatory fluid delivery device in is a safe condition to perform as intended after the software update comprising an indication of the ability to update the device history log.

18. The method of claim 17, further comprising prompting the user to configure the ambulatory fluid delivery device for regular operation.

19. The method of claim 18, wherein regular operation comprises the administration of one or more medications to a patient.

20. The method of claim 17, wherein the software update is only performed after confirming that the ambulatory fluid delivery device is in a safe condition for update.

21. The method of claim 18, wherein a safe condition for update comprises not currently administering a medicament, not being attached to a patient, a liquid medicament repository not being in fluid communication with the patient, not containing any medicament, or any combination thereof.

22. The method of claim 17, wherein verifying that the ambulatory fluid delivery device is in a safe condition to perform as intended further comprises:

verifying the ability to dispense one or more medicaments;

verifying the ability of the ambulatory fluid delivery device to accept sensor data to influence medicament dosing;

verifying the ability of the ambulatory fluid delivery device to repeatedly and safely perform dispensing actions;

or

any combination thereof.

23. The method of claim 17, wherein receiving confirmation from the central computer system that the ambulatory fluid delivery device has not exhibited unusual performance includes receiving confirmation that the ambulatory fluid delivery device has not exhibited unusual performance includes verifying an absence of error messages.

24. The method of claim 17, wherein receiving confirmation from the central computing system that a user of the ambulatory fluid delivery device wishes to update software on the ambulatory fluid delivery device includes:

presenting the user with a message and accepting user input via a user interface on the ambulatory fluid delivery device;

presenting the user with a message via a remote control and accepting user input via the remote control or via a user interface on the ambulatory fluid delivery device;

presenting the user with a message via an external computing device and accepting user input via the external computing device or via a user interface on the ambulatory fluid delivery device;

or

any combination thereof.