Infusion devices and related rescue detection methods

• US 10,117,992 B2
• Filed: 04/11/2016
• Issued: 11/06/2018
• Est. Priority Date: 09/29/2015
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Parikh, Neha J., Roy, Anirban, Grosman, Benyamin, Gottlieb, Rebecca K., Wu, Di
• Primary Examiner(s): Stiles, Amber
• Application Number:
  US15/096,156
• Publication Number:
  US 20170087300A1
• Time in Patent Office: 939 Days
• 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 2230/005 Parameter used as control input for the apparatus
• 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 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/168 Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body flow control in general G05D7/00
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver fluid to a body of a user involves obtaining measurement values for a physiological condition influenced by the fluid, autonomously operating the infusion device to deliver the fluid based at least in part on the measurement values, and detecting a nonactionable condition based on the measurement values. In response to detecting the nonactionable condition, delivery of the fluid is limited while maintaining autonomous operation of the infusion device. In one exemplary embodiment, the nonactionable condition is a rescue condition indicative of the user having consumed fast-acting carbohydrates, and thus insulin delivery may be automatically limited in response to detecting the rescue carbohydrate consumption.

Claims

1. A method of operating an infusion device to deliver fluid to a body of a user, the method comprising:

autonomously operating the infusion device to deliver the fluid based at least in part on measurement values for a physiological condition in the body of the user, the physiological condition being influenced by the fluid delivered by the infusion device; and

after detecting one of the measurement values below a rescue monitoring threshold;

verifying an absence of a meal indication; and

after verifying the absence of a meal indication;

analyzing subsequent measurement values of the measurement values to detect a rescue condition based on a characteristic of successive values of the subsequent measurement values; and

in response to detecting the rescue condition, limiting delivery of the fluid while autonomously operating the infusion device.

2. The method of claim 1, wherein detecting the rescue condition comprises determining a rate of change associated with the measurement values is greater than a threshold value.

3. The method of claim 1, further comprising:

detecting an absence of the rescue condition based on one or more of the measurement values after limiting the delivery of the fluid; and

in response to detecting the absence of the rescue condition, restoring the delivery of the fluid.

4. The method of claim 3, wherein:

limiting the delivery of the fluid comprises adjusting a delivery setting associated with the autonomously operating of the infusion device from an initial value; and

restoring the delivery of the fluid comprises restoring the delivery setting to the initial value.

5. The method of claim 1, wherein:

autonomously operating the infusion device comprises autonomously operating the infusion device to deliver a variable rate of infusion based at least in part on the measurement values and a target value for the physiological condition; and

limiting the delivery of the fluid comprises temporarily capping the variable rate.

6. The method of claim 1, wherein:

autonomously operating the infusion device comprises autonomously operating the infusion device to deliver a variable rate of infusion based at least in part on the measurement values and a target value for the physiological condition; and

limiting the delivery of the fluid comprises autonomously operating the infusion device to deliver a safe basal rate of infusion.

7. The method of claim 1, wherein:

autonomously operating the infusion device comprises autonomously operating the infusion device in a closed-loop operating mode to regulate the measurement values to a target value for the physiological condition; and

limiting the delivery of the fluid comprises autonomously operating the infusion device in a safe mode.

8. The method of claim 1, wherein:

autonomously operating the infusion device comprises autonomously operating the infusion device to deliver the fluid in a closed-loop mode based at least in part on the measurement values;

limiting the delivery of the fluid comprises autonomously operating the infusion device to deliver the fluid in a rescue mode; and

a first maximum rate of infusion associated with the rescue mode is less than a second maximum rate of infusion associated with the closed-loop mode.

9. The method of claim 8, further comprising:

detecting an exit condition while autonomously operating the infusion device to deliver the fluid in the rescue mode; and

in response to detecting the exit condition, resuming autonomously operating the infusion device to deliver the fluid in the closed-loop mode.

10. The method of claim 1, further comprising after limiting the delivery of the fluid, restoring the delivery of the fluid in response to a meal indication.

11. The method of claim 1, wherein the rescue monitoring threshold comprises a hypoglycemic event alert threshold.

12. The method of claim 1, wherein limiting delivery of the fluid while autonomously operating the infusion device comprises adjusting one or more control parameters of an autonomous control scheme to temporarily decrease responsiveness.

13. An infusion system comprising:

a sensing arrangement to obtain measurement values for a physiological condition from a body of a user; and

an infusion device including an actuation arrangement operable to deliver fluid to the body of the user and a control system coupled to the actuation arrangement, the fluid influencing the physiological condition of the user, wherein the control system is coupled to the sensing arrangement to autonomously operate the actuation arrangement to deliver a variable rate of infusion based on the measurement values, verify an absence of a meal indication after detecting one of the measurement values below a rescue monitoring threshold, analyze subsequent measurement values of the measurement values to detect a rescue condition based on a characteristic of successive values of the subsequent measurement values after verifying the absence of a meal indication, and temporarily limit the variable rate of infusion in response to the rescue condition.

14. The infusion system of claim 13, wherein the control system detects the rescue condition when a rate of change between the successive values of the measurement values is greater than a first threshold value.

15. The infusion system of claim 13, wherein the control system automatically restores the variable rate of infusion based on one or more of the measurement values after temporarily limiting the variable rate of infusion.

16. The infusion system of claim 13, wherein the infusion device includes a data storage element to maintain a delivery setting associated with autonomously operating the actuation arrangement, wherein the control system temporarily limits the variable rate of infusion by modifying the delivery setting.

17. An infusion device comprising:

an actuation arrangement operable to deliver fluid to a body of a user;

a data storage element to maintain control parameters for a closed-loop operating mode;

a communications interface to receive measurement values indicative of a physiological condition in the body of the user influenced by the fluid; and

a control module coupled to the actuation arrangement, the data storage element, and the communications interface to autonomously operate the actuation arrangement to deliver a variable rate of infusion based on the measurement values and the control parameters in accordance with the closed-loop operating mode, verify an absence of a meal indication after detecting one of the measurement values below a rescue monitoring threshold, analyze subsequent measurement values of the measurement values to detect a rescue condition based on one or more of the subsequent measurement values after verifying the absence of a meal indication, and adjust one or more of the control parameters to temporarily limit the variable rate of infusion in response to the rescue condition.

18. The infusion device of claim 17, wherein the control module adjusts the one or more of the control parameters to decrease responsiveness of the closed-loop operating mode in response to the rescue condition.

19. The infusion device of claim 17, the control parameters including closed-loop gain coefficients, wherein the control module adjusts the one or more of the closed-loop gain coefficients to temporarily limit the variable rate of infusion in response to the rescue condition.

20. The infusion device of claim 18, the control parameters including a maximum delivery rate, wherein the control module adjusts the maximum delivery rate to a lower delivery rate to temporarily limit the variable rate of infusion in response to the rescue condition.