INSULIN DELIVERY SYSTEMS AND METHODS

• US 20150352282A1
• Filed: 06/08/2015
• Published: 12/10/2015
• Est. Priority Date: 06/10/2014
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bryan Mazlish
• Inventors: MAZLISH, Bryan
• Granted Patent: US 10,188,793 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2209/01 Remote controllers for specific 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 5/1723 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
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A system is provided with an insulin delivery device configured to deliver insulin to a user of the system and a computer-based control unit associated with the insulin delivery device. The computer-based control unit includes a user interface and a computer-based processor. The computer-based processor is configured to calculate a relative insulin on board value for a specific time by calculating a first value that represents a reference insulin on board value at the specific time, calculating a second value that represents an automated insulin on board value at the specific time, and subtracting one of the first and second values from the other. The automated insulin on board value represents at least one insulin delivery automatically specified by the computer-based control unit. Methods of use are also disclosed.

Claims

1. A system comprising:

an insulin delivery device configured to deliver insulin to a user of the system; and

a computer-based control unit associated with the insulin delivery device, the computer-based control unit having a user interface and a computer-based processor,

wherein the computer-based processor is configured to calculate a relative insulin on board value for a specific time by calculating a first value that represents a reference insulin on board value at the specific time, calculating a second value that represents an automated insulin on board value at the specific time, and subtracting one of the first and second values from the other,

and wherein the automated insulin on board value represents at least one insulin delivery automatically specified by the computer-based control unit.

2. The system of claim 1, wherein the relative insulin on board calculation further includes adding a non-automated insulin on board value to the automated insulin on board value when calculating the second value, the non-automated insulin on board value representing at least one insulin delivery manually specified by the user or a caregiver

3. The system of claim 2, wherein the relative insulin on board calculation takes into account all insulin delivered to the user prior to the specific time that is believed to not have been completely absorbed by the user prior to the specific time, including any and all basal doses delivered to the user.

4. The system of claim 1, further comprising a glucose monitor configured to measure glucose values of the user, wherein the glucose monitor is configured to automatically transfer the glucose values to the computer-based control unit, and wherein the computer-based control unit is configured with a mode to automatically control insulin delivery to the user through the insulin delivery device, thereby forming an automatic feedback control loop.

5. The system of claim 4, wherein the computer-based processor is configured to calculate the relative insulin on board value by subtracting the first value from the second value.

6. The system of claim 4, wherein the calculation of the first value includes all insulin delivered according to a reference insulin delivery schedule and the second value includes all insulin delivered according to an automated insulin delivery schedule.

7. The system of claim 4, wherein the reference insulin on board value may be greater than the automated insulin on board value.

8. The system of claim 4, wherein the computer-based control unit is configured to display the relative insulin on board value on the user interface to the user or a caregiver.

9. The system of claim 8, wherein the computer-based control unit is configured to display a function of the relative insulin on board value as it is calculated to vary over a time period.

10. The system of claim 9, wherein at least a portion of the time period is a future time.

11. The system of claim 10, wherein the computer-based control unit is also configured to calculate and display a predicted change in glucose levels based on the function of the relative insulin on board value.

12. The system of claim 4, wherein the computer-based control unit is configured to calculate a future insulin delivery schedule based in part on the relative insulin on board value calculated by the computer-based processor, and wherein the insulin delivery device is configured to deliver insulin to the user of the system according to the calculated future insulin delivery schedule.

21. The insulin delivery device of claim 1, wherein the computer-based control unit further comprises a bolus calculator configured to assist the user or a caregiver with calculating a bolus dosage of insulin to be delivered to the user, wherein the bolus calculator is configured to use the calculated relative insulin on board value in determining a proper bolus dosage.

22. The insulin delivery device of claim 4, wherein the computer-based control unit further comprises a bolus calculator configured to assist the user or a caregiver with calculating a bolus dosage of insulin to be delivered to the user, wherein the bolus calculator is configured to use the calculated relative insulin on board value in determining a proper bolus dosage.

13. A system comprising:

an insulin delivery device configured to deliver insulin to a user of the system; and

a computer-based control unit associated with the insulin delivery device, the computer-based control unit having a user interface and a computer-based processor,

wherein the computer-based processor is configured to calculate a relative insulin on board value over a period of time by first calculating a difference-dosing-schedule, the difference-dosing-schedule being calculated by using a first schedule that represents a reference dosing and a second schedule that represents an automated dosing at each of a plurality of time points in the period of time, and at each of the plurality of time points subtracting one of the first and second schedule values at the time point from the other, and then calculating the relative insulin on board by calculating an insulin on board value for the difference-dosing-schedule by summing an insulin on board for each of the plurality of time points, and

wherein the automated dosing represents at least one insulin delivery automatically specified by the computer-based control unit.

14. The system of claim 13, further comprising a glucose monitor configured to measure glucose values of the user, wherein the glucose monitor is configured to automatically transfer the glucose values to the computer-based control unit, and wherein the computer-based control unit is configured with a mode to automatically control insulin delivery to the user through the insulin delivery device, thereby forming an automatic feedback control loop.

15. An insulin delivery device comprising:

an insulin delivery mechanism configured to deliver insulin to a user of the device; and

a computer-based control unit coupled to the insulin delivery mechanism to automatically deliver insulin to the user, the computer-based control unit having a user interface and a computer-based processor,

wherein the computer-based processor is configured to calculate a relative insulin on board value associated with a specific time period by calculating a first value that represents a reference insulin on board value associated with the specific time period, calculating a second value that represents an automated insulin on board value associated with the specific time period, and subtracting one of the first and second values from the other, wherein the automated insulin on board value represents at least one insulin delivery automatically specified by the computer-based control unit

wherein the reference insulin on board value may be greater than the automated insulin on board value,

wherein the computer-based control unit is configured to display the relative insulin on board value on the user interface to the user or a caregiver.

16. The insulin delivery device of claim 15, wherein the computer-based control unit further comprises a bolus calculator configured to assist the user or a caregiver with calculating a bolus dosage of insulin to be delivered to the user, wherein the bolus calculator is configured to use the calculated relative insulin on board value in determining a proper bolus dosage.

17. A method of delivering insulin to a user comprising:

providing an insulin delivery device configured to deliver insulin to a user of the system;

providing a computer-based control unit associated with the insulin delivery device, the computer-based control unit having a user interface and a computer-based processor;

calculating a relative insulin on board value for a specific time by calculating a first value that represents a reference insulin on board value at the specific time, calculating a second value that represents an automated insulin on board value at the specific time, and subtracting one of the first and second values from the other, wherein the automated insulin on board value represents at least one insulin delivery automatically specified by the computer-based control unit;

calculating an insulin dosage schedule based in part on the calculated relative insulin on board value; and

delivering insulin to the user according to the calculated insulin dosage schedule.

18. The method of claim 17, further comprising displaying the calculated relative insulin on board value to the user or a caregiver on the user interface.

19. The method of claim 18, further comprising allowing the user or a caregiver to manually enter an insulin dosage into the computer-based control unit through the user interface to be subsequently delivered to the user after the calculated relative insulin on board value has been displayed on the user interface.

20. The method of claim 17, wherein the reference insulin on board value may be greater than the automated insulin on board value.