Insertion site monitoring methods and related infusion devices and systems

• US 10,272,201 B2
• Filed: 12/22/2016
• Issued: 04/30/2019
• Est. Priority Date: 12/22/2016
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Loutseiko, Mikhail, Roy, Anirban, Grosman, Benyamin, Wu, Di, Gottlieb, Rebecca K., Parikh, Neha J.
• Primary Examiner(s): Hall, Deanna K
• Application Number:
  US15/389,246
• Publication Number:
  US 20180177946A1
• Time in Patent Office: 859 Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• 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 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

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

1. A method of operating an infusion device operable to deliver insulin to a body of a patient, the method comprising:

obtaining, from a sensing arrangement, sensed glucose measurement values of a glucose level in the body of the patient during fasting periods during an initial period after initialization of an infusion set associated with the infusion device;

determining a fasting amount of insulin in the body of the patient during the fasting periods;

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

after the initial period;

obtaining, from the sensing arrangement, an updated glucose measurement value during a subsequent fasting period;

determining a current amount of insulin in the body of the patient;

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

generating an insertion site notification based on a relationship between the current insulin estimate and the reference insulin estimate.

2. The method of claim 1, further comprising determining the current amount of insulin based on historical delivery data corresponding to preceding operation of the infusion device to deliver the insulin to the body of the patient.

3. The method of claim 2, further comprising determining a total daily insulin value based on the historical delivery data, wherein determining the current insulin estimate comprises calculating the current insulin estimate based on the updated glucose measurement value, the reference glucose value, the current amount of insulin, and the total daily insulin value.

4. The method of claim 2, further comprising verifying the glucose level in the body of the patient is stable prior to obtaining the sensed glucose measurement values.

5. The method of claim 2, further comprising verifying normal operation of the infusion device prior to obtaining the sensed glucose measurement values.

6. The method of claim 2, further comprising verifying absence of a meal within a threshold time period prior to obtaining the sensed glucose measurement values.

7. The method of claim 6, further comprising verifying the glucose level in the body of the patient is stable prior to obtaining the sensed glucose measurement values.

8. The method of claim 1, further comprising verifying absence of a meal within the threshold time period prior to obtaining the updated glucose measurement value.