IP Library Granted Patent US 11,590,282
Granted Patent B2
US 11,590,282 · App. 17/077,960 · Granted Feb 28, 2023

Insertion site monitoring methods and related infusion devices and systems

Inventors: Mikhail Loutseiko (Granada Hills, CA); Anirban Roy (Agoura Hills, CA); Benyamin Grosman (Valley Village, CA); Di Wu (Montrose, CA); Rebecca K. Gottlieb (Culver City, CA); Neha J. Parikh (West Hills, CA)
Assignee: Medtronic MiniMed, Inc.
A61M5/1723A61M5/14244A61M5/16836G16H20/17G16H40/63A61B5/14532A61B5/4839A61M2005/14208A61M2205/50A61M2205/502A61M2205/52A61M2230/201
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Quick Facts
Patent No.
US 11,590,282
App. No.
17/077,960
Granted
Feb 28, 2023
Kind
B2
Abstract

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device involves obtaining one or more measurement values of a physiological condition in the body of a user during an initial monitoring period and determining a fasting reference value for a metric based on the one or more measurement values. After the initial monitoring period, the method continues by obtaining an updated measurement value during a fasting period, determining a current value for the metric based at least in part on the updated measurement value, and generating a notification in response to a deviation between the current value and the fasting reference value exceeding a threshold indicative of insertion site loss or other loss of effectiveness.

Claims (45)

1. A method of operating a medical device, the method comprising:

detecting a site loss condition associated with a site associated with the medical device based at least in part on measurement values for a physiological condition in a body of a user; and

in response to detecting the site loss condition, providing, via a user interface, a user notification that indicates the site loss condition associated with the site.

2. The method of claim 1 , wherein providing the user notification comprises indicating the user needs to change the site.

3. The method of claim 1 , wherein providing the user notification comprises analyzing historical site location information to provide guidance.

4. The method of claim 1 , further comprising calculating a frequency or a rate at which the site is utilized using historical data, wherein providing the user notification comprises providing guidance to change the site based at least in part on the frequency or the rate at which the site is utilized.

5. The method of claim 1 , wherein providing the user notification comprises analyzing one or more of historic delivery data, measurement data and historical site location information to provide guidance as to a cause of the user notification.

6. The method of claim 1 , further comprising determining a current value for a metric based on one or more of the measurement values, wherein detecting the site loss condition comprises detecting the site loss condition when a difference between the current value for the metric and a reference value for the metric is greater than a threshold.

7. The method of claim 1 , further comprising averaging a subset of the measurement values during an initial period to obtain an average measurement value, wherein detecting the site loss condition comprises detecting the site loss condition when a difference between a current measurement value and the average measurement value is greater than a threshold.

8. The method of claim 1 , wherein providing the user notification comprises providing one or more graphical user interface (GUI) notifications on a portable electronic device communicatively coupled to the medical device.

9. The method of claim 8 , wherein the one or more GUI notifications comprise guidance influenced by a frequency or a rate at which the site is utilized.

10. A computer-readable medium having computer-executable instructions stored thereon that, when executed by a processor, cause the processor to:

detect a site loss condition associated with a site associated with a medical device based at least in part on measurement values for a physiological condition in a body of a user; and

provide a user notification that indicates the site loss condition associated with the site via a user interface in response to detecting the site loss condition.

11. The computer-readable medium of claim 10 , wherein:

the physiological condition comprises a glucose level;

the measurement values include a current glucose measurement value; and

the computer-executable instructions cause the processor to detect the site loss condition by:

determining a current insulin estimate for achieving a reference glucose value based at least in part on the current glucose measurement value; and

detect the site loss condition based on a relationship between the current insulin estimate and a reference insulin estimate.

12. The computer-readable medium of claim 11 , wherein the computer-executable instructions cause the processor to:

obtain, from a sensing arrangement, sensed glucose measurement values of the glucose level in the body of the user during fasting periods during an initial period;

determine fasting amount of insulin in the body of the user during the fasting periods; and

determine the reference insulin estimate for achieving the reference glucose value based at least in part on the fasting amount of insulin and the sensed glucose measurement values.

13. The computer-readable medium of claim 12 , wherein the computer-executable instructions cause the processor to:

determine a current amount of insulin in the body of the user; and

determine the current insulin estimate for achieving the reference glucose value based at least in part on the current amount of insulin and the current glucose measurement value.

14. The computer-readable medium of claim 10 , wherein the computer-executable instructions cause the processor to:

calculate a frequency or a rate at which the site is utilized using historical data;

provide guidance to change the site based at least in part on the frequency or the rate at which the site is utilized.

15. The computer-readable medium of claim 10 , wherein the computer-executable instructions cause the processor to analyze one or more of historic delivery data, measurement data and historical site location information to provide guidance as to a cause of the user notification.

16. The computer-readable medium of claim 10 , wherein the user notification comprises guidance to change the site based at least in part on a frequency or a rate at which the site is utilized.

17. The computer-readable medium of claim 10 , wherein the computer-executable instructions cause the processor to provide the user notification as one or more graphical user interface (GUI) notifications on a portable electronic device communicatively coupled to the medical device.

18. The computer-readable medium of claim 17 , wherein the one or more GUI notifications provide guidance based at least in part on a frequency or a rate at which the site is utilized.

19. An electronic device comprising:

a user interface; and

a control module coupled to the user interface, wherein the control module is configured to:

detect a site loss condition associated with a site associated with a medical device based on one or more measurement values for a physiological condition in a body of a patient; and

provide a graphical user interface (GUI) notification that indicates the site loss condition associated with the site via the user interface.

20. The electronic device of claim 19 , wherein the control module is configured to:

determine a reference value for a metric based on sensed measurement values for the physiological condition in the body of the patient during an initial period;

after the initial period:

obtain an updated measurement value for the physiological condition in the body of the patient;

determine a current value for the metric based at least in part on the updated measurement value; and

detect the site loss condition based on a relationship between the current value for the metric and the reference value for the metric.

Assignments (1)
SECURITY INTEREST Recorded Jan 16, 2026
From: MEDTRONIC MINIMED, INC.; COMPANION MEDICAL, INC.
To: CITIBANK, N.A.
Reel/Frame 074394/0237 →