Systems and methods for self-validation of hardware and software for safety-critical medical devices

Patent metadata

Field	Value
Publication number	US-11823797-B2
Application number	US-202217903181-A
Country	US
Kind code	B2
Filing date	Sep 6, 2022
Priority date	May 2, 2019
Publication date	Nov 21, 2023
Grant date	Nov 21, 2023

Abstract

Medical devices critical to patient health and safety that communicate with third party hardware and software, such as smart devices, require validation to ensure compatibility and correct performance. Disclosed are methods and systems to perform a self-validation of hardware and/or software components with a medical device to confirm that any combination of hardware and software are compatible and perform acceptably. If the self-validation passes then the user may safely use the system, and it may report to a cloud server that the particular configuration tested was successful. If the self-validation fails, the user will be prevented from using safety-critical aspects of the application and be notified of the incompatibility; and the results may also be reported to a cloud server.

First claim

What is claimed is:

1. A medicine administering system, comprising:
a medical device configured for administering medicine; and
a software application configured to be installed on a mobile communication device, the software application including instructions for:
establishing a wireless communication connection between the medical device and the mobile communication device;
terminating the established wireless connection between the medical device and the mobile communication device; and
executing a connectivity test, the connectivity test including:
reestablishing the wireless connection between the medical device and the mobile communication device;
causing data to be transferred from the medical device to the mobile communication device via the reestablished wireless connection between the medical device and the mobile communication device; and
determining an integrity of the transferred data.

2. The medicine administering system according to claim 1 , wherein the connectivity test further includes determining a transfer rate of the transferred data.

3. The medicine administering system according to claim 1 , wherein the connectivity test further includes determining a latency of the reestablished wireless connection between the medical device and the mobile communication device.

4. The medicine administering system according to claim 3 , wherein the latency of the reestablished wireless connection between the medical device and the mobile communication device is determined based on an elapsed period of time between an initiation of an advertising of data by the medical device and the reestablishing of the wireless connection between the medical device and the mobile communication device.

5. The medicine administering system according to claim 1 , wherein the data caused to be transferred from the medical device to the mobile communication device via the reestablished wireless connection between the medical device and the mobile communication device is a pre-set sequence of data packets.

6. The medicine administering system according to claim 5 , wherein the connectivity test further includes determining the integrity of the transferred data based on a comparison between the pre-set sequence of data packets and an expected pre-set sequence of data packets.

7. The medicine administering system according to claim 5 , wherein the connectivity test further includes verifying that a minimum number of the pre-set data packets were received by the mobile communication device.

8. The medicine administering system according to claim 1 , wherein the connectivity test further includes assessing a result of the connectivity test.

9. The medicine administering system according to claim 1 , wherein the software application includes instructions for verifying a system minimum requirement of the mobile communication device.

10. The medicine administering system according to claim 1 , wherein establishing a wireless communication connection between the medical device and the mobile communication device includes generating a prompt on the mobile communication device for a user to activate the medical device within a wireless communication range of the mobile communication device.

11. A medicine administering system, comprising:
a medical device configured for administering medicine; and
a software application configured to be installed on a mobile communication device, the software application including instructions for:
establishing a wireless connection between the medical device and the mobile communication device;
terminating the established wireless connection between the medical device and the mobile communication device;
commanding the medical device to conduct a connectivity test, the connectivity test including:
reestablishing the wireless connection between the medical device and the mobile communication device;
determining a latency of the reestablished wireless connection between the medical device and the mobile communication device; and
causing data to be transferred from the medical device to the mobile communication device via the reestablished wireless connection between the medical device and the mobile communication device.

12. The medicine administering system according to claim 11 , wherein the connectivity test further includes determining an integrity of the data transferred from the medical device to the mobile communication device via the reestablished wireless connection.

13. The medicine administering system according to claim 12 , wherein the integrity of the data transferred from the medical device to the mobile communication device is determined based on a comparison between a pre-set sequence of data packets transferred from the medical device to the mobile communication device and an expected pre-set sequence of data packets.

14. The medicine administering system according to claim 11 , wherein the connectivity test further includes assessing a result of the connectivity test.

15. The medicine administering system according to claim 11 , wherein the software application includes instructions for verifying a system minimum requirement of the mobile communication device.

16. A medicine administering device configured for pairing with a mobile communication device, comprising:
an electronics unit including a processor and a memory storing instructions, which when executed by the processor, cause the electronics unit to:
establish a wireless connection between the medicine administering device and the mobile communication device;
terminate the established wireless connection between the medicine administering device and the mobile communication device; and
execute a connectivity test by:
reestablishing the wireless connection between the medicine administering device and the mobile communication device; and
transferring data from the medicine administering device to the mobile communication device via the reestablished wireless connection for determining a transfer rate of the transferred data and an integrity of the transferred data.

17. The medicine administering device according to claim 16 , wherein the instructions, when executed by the processor, cause the electronics unit to transmit, to the mobile communication device, an elapsed period of time between an initiation of an advertising of data by the medical device and the reestablishing of the wireless connection between the medicine administering device and the mobile communication device for determining a latency of the reestablished connection.

18. The medicine administering device according to claim 16 , wherein the data transferred from the medicine administering device to the mobile communication device via the reestablished wireless connection is a pre-set sequence of data packets.

19. The medicine administering device according to claim 18 , wherein the integrity of the transferred data is determined based on a comparison between the pre-set sequence of data packets and an expected pre-set sequence of data packets.

20. The medicine administering device according to claim 18 , wherein the pre-set sequence of data packets is transferred from the medicine administering device to the mobile communication device for a pre-set amount of time for verifying that a minimum number of the pre-set data packets were received by the mobile communication device.

Assignees

• Medtronic Minimed Inc

Inventors

• Holmquist Arnold
• Cohen Eric
• Hampapuram Haripriyan
• Mensinger Michael

Classifications

• G16H40/67 Primary

  for remote operation · CPC title

• G16H20/17 Primary

  delivered via infusion or injection · CPC title

• H04L43/0811

  by checking connectivity · CPC title

• H04L43/50

  Testing arrangements · CPC title

• H04W24/08

  Testing, {supervising or monitoring} using real traffic · CPC title