System and method for infusion set dislodgement detection

• US 10,549,051 B2
• Filed: 01/15/2018
• Issued: 02/04/2020
• Est. Priority Date: 06/21/2013
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Rosinko, Michael
• Primary Examiner(s): Gilbert, Andrew M
• Application Number:
  US15/871,665
• Publication Number:
  US 20180193573A1
• Time in Patent Office: 750 Days
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

A portable insulin pump can utilize readings from a sensor incorporated into an infusion set used with the pump to deliver insulin to a patient to determine if the infusion set is or is likely to become dislodged from the patient. Readings from the sensor that are inconsistent with expected readings or a range of expected readings can indicate that the infusion set has become dislodged from the patient.

Claims

1. A method of detecting dislodgement of an infusion set of a portable infusion pump, comprising:

receiving information obtained by a glucose sensor that obtains readings relating to glucose levels of a user;

determining, via a processor configured to determine from estimated glucose levels determined based on the sensor readings, that the glucose sensor has become dislodged from the user;

determining, based on the estimated glucose levels indicating dislodgement of the glucose sensor, that a cannula fluidly connected to a portable infusion pump the portable infusion pump to deliver medicament to the user is or is likely to become dislodged from the user; and

notifying the user of potential dislodgement of the cannula from the user if it is determined that the cannula is or is likely to become dislodged.

2. The method of claim 1, wherein notifying the user of potential dislodgement of the cannula provides the notification on a user interface of the portable infusion pump.

3. The method of claim 1, wherein notifying the user of potential dislodgement of the cannula provides the notification on a user interface of a remote control device.

4. The method of claim 1, wherein the glucose sensor and the cannula are mechanically linked to each other.

5. The method of claim 4, wherein the cannula and the glucose sensor are mechanically linked to each other by both being connected to a patch adapted to retain the cannula in the user.

6. The method of claim 1, wherein determining that the glucose sensor has become dislodged from the user includes determining that the estimate glucose levels are outside of an expected range relating to typical glucose levels.

7. The method of claim 1, wherein determining that the glucose sensor has become dislodged from the user includes determining that one or more estimated glucose levels are above a high threshold or below a low threshold.

8. The method of claim 1, further comprising discontinuing delivery of medicament with the portable infusion pump upon determining that the cannula is or is likely to become dislodged.

9. The method of claim 8, further comprising:

receiving, after discontinuing delivery of medicament, an indication from the user that the cannula is properly attached to the user; and

reinitiating delivery of medicament with the portable infusion pump in response to the indication.

10. The method of claim 1, wherein the glucose sensor and the cannula are configured for common transcutaneous insertion into the user at a single insertion location.

11. A method of delivering a medicament to a user with a portable infusion pump, comprising:

receiving information obtained by a glucose sensor that obtains readings relating to glucose levels of a user;

delivering a medicament to the user based on the information obtained by the glucose sensor;

determining, via a processor configured to determine from estimated glucose levels determined based on the sensor readings, that the glucose sensor has become dislodged from the user;

determining, based on the estimated glucose levels indicating dislodgement of the glucose sensor, that a cannula fluidly connected to a portable infusion pump the portable infusion pump to deliver medicament to the user is or is likely to become dislodged from the user; and

automatically discontinuing delivery of the medicament with the portable infusion pump upon determining that the cannula is or is likely to become dislodged.

12. The method of claim 11, further comprising:

receiving, after discontinuing delivery of medicament, an indication from the user that the cannula is properly attached to the user; and

reinitiating delivery of medicament with the portable infusion pump in response to the indication.

13. The method of claim 11, further comprising notifying the user of potential dislodgement of the cannula from the user if it is determined that the cannula is or is likely to become dislodged.

14. The method of claim 13, wherein notifying the user of potential dislodgement of the cannula provides the notification on a user interface of the portable infusion pump.

15. The method of claim 13, wherein notifying the user of potential dislodgement of the cannula provides the notification on a user interface of a remote control device.

16. The method of claim 11, wherein the glucose sensor and the cannula are mechanically linked to each other.

17. The method of claim 16, wherein the cannula and the glucose sensor are mechanically linked to each other by both being connected to a patch adapted to retain the cannula in the user.

18. The method of claim 11, wherein determining that the glucose sensor has become dislodged from the user includes determining that the estimate glucose levels are outside of an expected range relating to typical glucose levels.

19. The method of claim 11, wherein determining that the glucose sensor has become dislodged from the user includes determining that one or more estimated glucose levels are above a high threshold or below a low threshold.

20. The method of claim 11, wherein the glucose sensor and the cannula are configured for common transcutaneous insertion into the user at a single insertion location.