Field update of an ambulatory infusion pump system

• US 9,895,491 B2
• Filed: 01/14/2016
• Issued: 02/20/2018
• 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:
  US14/995,958
• Publication Number:
  US 20160129185A1
• Time in Patent Office: 768 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 an ambulatory fluid delivery device comprising:

from a computing system, interrogating the ambulatory fluid delivery device and obtaining data, from the ambulatory fluid delivery device, the data including a patient basal medication dosage profile and device history logs;

by the computing system, verifying that 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;

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 computing system to the ambulatory fluid delivery device;

verifying that the ambulatory fluid delivery device is in a safe condition for the software update, including verifying an absence of error messages within a certain time period in the device history logs;

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.

2. The method of claim 1, further comprising, by the computing system:

receiving a password from the ambulatory fluid delivery device; and

verifying the password received from the ambulatory fluid delivery device.

3. The method of claim 1, wherein the computing system includes a central computing system and an intermediate computing device, and further comprising, by the intermediate computing device, facilitating communications relating to the software update between the ambulatory fluid delivery device and the central computing system.

4. The method of claim 3, wherein the intermediate computing device comprises a portable computing device.

5. The method of claim 1, wherein the step of verifying that the ambulatory fluid delivery device is in a safe condition for the software update is performed prior to the step of sending the software update to the ambulatory fluid delivery device.

6. A system for remotely updating software operating on an ambulatory fluid delivery device, comprising:

an ambulatory fluid delivery device; and

a computing system having a hardware processor configured to remotely update software operating on the ambulatory fluid delivery device, wherein upon determining that a software update is available for the ambulatory fluid delivery device the hardware processor of the computing system is programmed to;

interrogate the ambulatory fluid delivery device to obtain data from the ambulatory fluid delivery device, the data including a patient basal medication dosage profile and device history logs;

verify that 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;

verify that a user of the ambulatory fluid delivery device wishes to update software on the ambulatory fluid delivery device;

send the software update to the ambulatory fluid delivery device;

verify that the ambulatory fluid delivery device is in a safe condition for the software update, including verifying an absence of error messages within a certain time period in the device history logs;

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

verify that the ambulatory fluid delivery device is in a safe condition to perform as intended after the software update.

7. The system of claim 6, wherein the central computing system is further programmed to:

receive a password from the ambulatory fluid delivery device; and

verify the password received from the ambulatory fluid delivery device.

8. The system of claim 6, wherein the computing system includes a central computing system and an intermediate computing device, the intermediate computing device configured to facilitate communications relating to the software update between the ambulatory fluid delivery device and the central computing system.

9. The system of claim 8, wherein the intermediate computing device comprises a portable computing device.

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

the ambulatory fluid delivery device not currently administering a medicament,

the ambulatory fluid delivery device not being attached to a patient, and

a liquid medicament repository not being in fluid communication with the patient.

11. The system of claim 6, wherein verifying that the ambulatory fluid delivery device is in a safe condition to perform as intended after the software update comprises one or more of:

verifying an ability of the ambulatory fluid delivery device to dispense one or more medicaments;

verifying an ability of the ambulatory fluid delivery device to update a device history log; and

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

12. The system of claim 6, wherein verifying a user of the ambulatory fluid delivery device wishes to update software on the ambulatory fluid delivery device includes receiving an indication of user input accepting a message pertaining to the software update.

13. The system of claim 6, wherein the hardware processor of the computing system is programmed to verify that the ambulatory fluid delivery device is in a safe condition for the software update prior to sending the software update to the ambulatory fluid delivery device.

14. A system for remotely updating software operating on an ambulatory fluid delivery device, comprising;

an ambulatory fluid delivery device;

a central computing system having a hardware processor and located remotely from the ambulatory fluid delivery device; and

an intermediate computing system having hardware processor configured to facilitate an update to software operating on the ambulatory fluid delivery device via the central computing system, wherein the intermediate computing device is programmed to;

interrogate the ambulatory fluid delivery device to obtain data from the ambulatory fluid delivery device, the data including a patient basal medication dosage profile and device history logs;

verify that 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;

verify that a user of the ambulatory fluid delivery device wishes to update software on the ambulatory fluid delivery device;

receive the software update from the central computing system;

send the software update to the ambulatory fluid delivery device;

verify that the ambulatory fluid delivery device is in a safe condition for the software update, including verifying an absence of error messages within a certain time period in the device history logs;

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

verify that the ambulatory fluid delivery device is in a safe condition to perform as intended after the software update.

15. The system of claim 14, wherein the intermediate computing device is further programmed to:

receive a password from the ambulatory fluid delivery device; and

verify the password received from the ambulatory fluid delivery device with the central computing system.

16. The system of claim 14, wherein the intermediate computing device comprises a portable computing device.

17. The system of claim 14, where a safe condition for the software update comprises one or more of:

the ambulatory fluid delivery device not currently administering a medicament,

the ambulatory fluid delivery device not being attached to a patient, and

a liquid medicament repository not being in fluid communication with the patient.

18. The system of claim 14, wherein verifying that the ambulatory fluid delivery device is in a safe condition to perform as intended after the software update comprises one or more of:

verifying an ability of the ambulatory fluid delivery device to dispense one or more medicaments;

verifying an ability of the ambulatory fluid delivery device to update a device history log; and

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

19. The system of claim 14, wherein verifying a user of the ambulatory fluid delivery device wishes to update software on the ambulatory fluid delivery device includes receiving an indication of user input accepting a message pertaining to the software update.

20. The system of claim 14, wherein the intermediate computing device is programmed to verify that the ambulatory fluid delivery device is in a safe condition for the software update prior to sending the software update to the ambulatory fluid delivery device.