Operating an infusion pump system

• US 10,661,007 B2
• Filed: 08/18/2016
• Issued: 05/26/2020
• Est. Priority Date: 03/01/2013
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Estes, Mark C.
• Primary Examiner(s): Schmidt, Emily L
• Application Number:
  US15/240,220
• Publication Number:
  US 20170043084A1
• Time in Patent Office: 1,377 Days
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/18 with alarm
• 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 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• 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 5/14566 with a replaceable reservoir for receiving a piston rod of the pump

Abstract

Some embodiments of an infusion pump system can be configured to provide improved safety monitoring features so that a user receives proper dosage amounts.

Claims

1. A method of operating a portable insulin infusion system, the method comprising:

receiving manual user input at a user interface of the insulin infusion system indicative of a value for a first user-specific setting for a first parameter type, the first parameter type being a user'"'"'s insulin sensitivity or a user'"'"'s carbohydrate ratio;

retrieving a previously stored value for a second user-specific setting for a second parameter type, the second parameter type being a total daily basal dosage amount for the user;

determining, using the value for the second user-specific setting, a range for the first parameter type, wherein a first upper threshold for the range and a first lower threshold for the range is determined as a function of the total daily basal dosage amount for the user, the first upper threshold being different than the first lower threshold;

comparing the value for the first user-specific setting to the determined range for the first parameter type to determine that the value for the first user-specific setting is outside of the range for the first parameter type;

receiving data indicative of the user'"'"'s blood glucose level from a glucose monitoring device;

calculating a recommended bolus amount based at least in part on the first parameter type;

displaying the recommended bolus amount to the user on a user interface of the insulin infusion system; and

outputting an alert in response to determining that the value for the first user-specific setting is outside of the range for the first parameter type.

2. The method of claim 1, wherein the alert comprises a textual alert message indicating that an input value for the first user-specific setting is out of balance with the previously stored value for the second user-specific setting.

3. The method of claim 1, further comprising, in response to determining that the value for the first user-specific setting is outside of the range for the first parameter type, prompting the user to select a first option via a user interface indicative of an instruction to continue with the value for the first user-specific setting or to select a second option via the user interface indicative of an instruction to provide a new value for the first user-specific setting, wherein the first option and second option are contemporaneously displayed via the user interface.

4. The method of claim 3, wherein in response to user selection of the first option via the user interface, the user input for the first user-specific setting is stored in a memory device.

5. The method of claim 3, wherein in response to user selection of the second option via the user interface, prompting the user to input the new value for the first user-specific setting via the user interface.

6. The method of claim 1 wherein the first parameter type is the user'"'"'s insulin sensitivity.

7. The method of claim 6, wherein the recommended bolus is a correction bolus that is determined using the user'"'"'s blood glucose level and the user'"'"'s insulin sensitivity.

8. The method of claim 1, wherein the insulin infusion system comprises a disposable and non-reusable insulin delivery device and a removable controller device,

the insulin delivery device comprising:

an insulin cartridge comprising a plunger, a septum, and insulin

a housing that retains the insulin cartridge; and

a drive system comprising a piston rod that is incrementally movable to apply a dispensing force to the plunger to dispense insulin through the septum;

the removable controller comprising;

a controller housing that is removably attachable to the housing of the insulin delivery device; and

a wireless communication device to receive the user'"'"'s blood glucose level from the glucose monitoring device.

9. A method of operating a portable insulin infusion pump system, the method comprising:

dispensing insulin from a portable housing of an infusion pump system; and

storing a total daily basal dosage amount for a user;

calculating an insulin sensitivity range using the stored total daily basal dosage amount for the user, the insulin sensitivity range having a first upper threshold that is distinct from a first lower threshold of the insulin sensitivity range;

determining that a stored insulin sensitivity value for the user is outside of the calculated insulin sensitivity range; and

outputting an alert via a user interface of the system in response to determining that the stored insulin sensitivity value for the user is outside of the calculated insulin sensitivity range.

10. The method of claim 9, wherein the alert comprises a textual alert message indicating that the stored insulin sensitivity value for the user is out of balance with the stored total daily basal dosage amount for the user.

11. The method of claim 9, further comprising, in response to determining that a stored insulin sensitivity value for the user is outside of the calculated insulin sensitivity range, prompting the user to select a first option via a user interface indicative of an instruction to continue operating with the stored insulin sensitivity value for the user or to select a second option via the user interface indicative of an instruction to provide a new value for the insulin sensitivity value for the user, wherein the first option and second option are contemporaneously displayed via the user interface.

12. The method of claim 11, wherein in response to user selection of the second option via the user interface, prompting the user to input the new value for the insulin sensitivity value for the user via the user interface.

13. A method of operating a portable infusion pump system comprising:

dispensing medicine from a portable housing of an infusion pump system;

receiving user input at a user interface of the infusion pump system to initiate a first bolus dosage of the medicine;

receiving, at the infusion pump system and after receiving the user input to initiate the first bolus dosage, blood glucose information indicative of a user'"'"'s blood glucose measurements over a period of time, the blood glucose information being obtained from a blood glucose meter device and/or a glucose monitoring device;

determining a rate of change of the user'"'"'s blood glucose measurements over the period of time;

identifying that an infusion set error of a second bolus dosage administered prior to receiving the user input to initiate the first bolus dosage has occurred based on determining that the rate of change of the user'"'"'s blood glucose measurements has not decreased over the predetermined period of time; and

outputting an alert via the user interface of the infusion pump system in response to the infusion pump system identifying that the infusion set error has occurred based on determining that the rate of change of the user'"'"'s blood glucose measurements has not decreased over the predetermined period of time.

14. The method of claim 13, wherein the alert output via the user interface comprises a textual alert message indicating the infusion set error.

15. The method of claim 13, and wherein the infusion pump system detects the infusion set error in response to a determination by the infusion pump system that the blood glucose information indicates that a user'"'"'s blood glucose level is not decreasing over a predetermined period of time after initiating the first bolus dosage.