System and method for infusion set dislodgement detection

• US 9,867,953 B2
• Filed: 06/21/2013
• Issued: 01/16/2018
• 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
• Application Number:
  US13/923,556
• Publication Number:
  US 20140378898A1
• Time in Patent Office: 1,670 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 portable insulin pump system, comprising:

a user interface adapted to display operating information and to receive input data from a user;

a receiver adapted to receive information obtained by a glucose sensor that obtains sensor readings relating to glucose levels of the user; and

a processor functionally linked to the receiver and to the user interface to control display of information on the user interface, wherein the processor is configured to;

determine, from estimated glucose levels determined based on the sensor readings, that the glucose sensor has become dislodged from the user;

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

provide an alert 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 portable insulin pump system of claim 1, wherein the processor determines that the glucose sensor has become dislodged if the estimated glucose levels are outside of an expected range relating to typical glucose levels.

3. The portable insulin pump system of claim 1, wherein the processor determines that the glucose sensor has become dislodged based on one or more estimated glucose levels that are above a high threshold or below a low threshold.

4. The portable insulin pump system of claim 1, wherein the processor is further configured to discontinue delivery of insulin upon determining that the cannula is or is likely to become dislodged.

5. The portable insulin pump system of claim 1, wherein the receiver receives the information obtained by the glucose sensor directly from the glucose sensor.

6. The portable insulin pump system of claim 1, wherein the receiver receives the information obtained by the glucose sensor from a standalone glucose monitor that is functionally linked with the glucose sensor.

7. The portable insulin pump system of claim 1, wherein the glucose sensor and the cannula are configured for common transcutaneous insertion into the user at a single insertion location.

8. The portable insulin pump system of claim 1, further comprising the cannula, and wherein the glucose sensor and the cannula are adapted to be inserted at different insertion sites on the user.

9. The portable insulin pump system of claim 8, wherein the cannula and the glucose sensor are mechanically linked to each other.

10. The portable insulin pump system of claim 9, 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.

21. The portable insulin pump system of claim 7, wherein the glucose sensor is concentrically arranged around the cannula.

11. A portable insulin system, comprising:

a portable insulin pump including a user interface adapted to display operating information and to receive input data from a user, a receiver and a processor functionally linked to the receiver to receive information from the receiver and to the user interface to control display of information on the user interface;

a glucose sensor adapted to obtain sensor readings relating to glucose levels of a user; and

an infusion set, the infusion set including a cannula adapted to be inserted into the user, tubing attached to the cannula to transmit insulin delivered with the portable insulin pump to the cannula and an adhesive patch adapted to retain the infusion set on the user; and

wherein the processor of the portable insulin pump is adapted to;

determine, from estimated glucose levels determined based on the sensor readings obtained by the glucose sensor, that the glucose sensor has become dislodged from the user;

determine, based on the estimated glucose levels indicating dislodgement of the glucose sensor, that the cannula is or is likely to become dislodged from the user; and

provide an alert on the user interface 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.

12. The portable insulin system of claim 11, wherein the processor determines that the glucose sensor has become dislodged if the estimated glucose levels are outside of an expected range relating to typical glucose levels.

13. The portable insulin system of claim 11, wherein the processor determines that the glucose sensor has become dislodged based on one or more estimated glucose levels that are above a high threshold or below a low threshold.

14. The portable insulin system of claim 11, wherein the processor is further configured to discontinue delivery of insulin upon determining that the cannula is or is likely to become dislodged.

15. The portable insulin system of claim 11, wherein the receiver receives the information obtained by the glucose sensor directly from the glucose sensor.

16. The portable insulin system of claim 11, wherein the receiver receives the information obtained by the glucose sensor from a standalone glucose monitor that is functionally linked with the glucose sensor.

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

18. The portable insulin system of claim 11, wherein the glucose sensor and the cannula are adapted to be inserted at different insertion sites on the user.

19. The portable insulin system of claim 18, wherein the cannula and the glucose sensor are mechanically linked to each other.

20. The portable insulin system of claim 19, wherein the cannula and the glucose sensor are mechanically linked to each other by both being connected to the adhesive patch.

22. The portable insulin pump system of claim 17, wherein the glucose sensor is concentrically arranged around the cannula.