Infusion pump systems and methods

• US 7,959,598 B2
• Filed: 08/20/2008
• Issued: 06/14/2011
• Est. Priority Date: 08/20/2008
• Status: Active Grant

• Current Assignee: Insulet Corporation, M2 Medical Group Holdings, Inc.
• Original Assignee: Asante Solutions, Inc
• Inventors: Estes, Mark C.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Thomas, Jr.; Bradley G
• Application Number:
  US12/195,034
• Publication Number:
  US 20100049164A1
• Time in Patent Office: 1,028 Days
• Field of Search: 604/131, 604/151, 604/143, 604/890.1, 604 65- 67, 604/31, 604503-504, 702/27
• US Class Current: 604/65
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2202/0007 introduced into the body
• 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 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• 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

Abstract

Some embodiments an infusion pump system can be used to determine a user'"'"'s total insulin load (TIL) that provides an accurate indication of the insulin previously delivered to the user'"'"'s body which has not yet acted. In particular embodiments, the TIL can account for both the bolus deliveries and the basal deliveries that have occurred over a period of time. Such information may be useful, for example, when the infusion pump is operated in conjunction with a continuous glucose monitoring device.

Claims

1. A medical infusion pump system, comprising:

a portable pump housing that receives insulin for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense the insulin through a flow path to the user;

a controller that activates the pump drive system to dispense the insulin from the portable pump housing;

a monitoring device that communicates glucose information to the controller, the glucose information being indicative of a blood glucose level of the user; and

a user interface coupled to the controller including a display device that contemporaneously displays a glucose value indicative of the blood glucose level of the user and a total insulin load indicative of bolus and basal insulin dosages that have dispensed but not yet acted in the user.

3. The system of claim 1, wherein the total insulin load is determined by the controller according to a function that accounts for (i) a bolus insulin load indicative of one or more bolus insulin dosages that have been dispensed into the user but not yet acted in the user, (ii) a basal insulin load indicative of one or more basal insulin dosages that have been dispensed into the user from the portable infusion pump system but not yet acted in the user;

and (iii) a previous food component based upon previous food intake that has not yet metabolized in the user.

4. The system of claim 1, further comprising a computer-readable memory device coupled to the controller that stores one or more calculated values for the total insulin load and one or more corresponding time values.

5. The system of claim 4, wherein the controller further comprises a data connection instrument to export the calculated values for the total insulin load and the corresponding time values to an external computer system.

6. The system of claim 5, wherein when the controller exports the calculated values for the total insulin load and the corresponding time values to the external computer system, the external computer system displays the calculated values for the total insulin load in a time-based plot.

7. The system of claim 1, wherein the user interface includes the display device and a plurality of user-actuatable buttons.

8. The system of claim 7, the display device contemporaneously displays the glucose value and the total insulin load in a default screen that is displayed when the user has not actuated any of the buttons for a particular period of time.

9. The system of claim 8, wherein the total insulin load is determined by the controller according to a function that accounts for at least (i) a bolus insulin load indicative of one or more bolus insulin dosages that have been dispensed into the user but not yet acted in the user, and (ii) a basal insulin load indicative of one or more basal insulin dosages that have been dispensed into the user from the portable infusion pump system but not yet acted in the user.

10. The system of claim 1, wherein the controller comprises a controller housing that removably attaches to the pump housing, the controller being electrically connected to the pump drive system when the controller housing is removably attached to the pump housing.

11. The system of claim 10, wherein the controller is a reusable device and the pump housing and pump drive system are disposable and nonreusable.

12. The system of claim 1, wherein the portable pump housing receives a prefilled cartridge of the insulin through an opening in the pump housing that is coverable with a cap device, and the flow path of the insulin comprises and an infusion set tube that extends from the cap device to the user.

14. A method of operating the medical infusion pump system of claim 1, comprising:

determining the total insulin load for a particular time that accounts for a bolus insulin load, a basal insulin load, and a previous food component, wherein;

the bolus insulin load is indicative of one or more bolus insulin dosages that have been dispensed into a user from the medical infusion pump system but not yet acted in the user, the basal insulin load is indicative of one or more basal insulin dosages that have been dispensed into the user from the medical infusion pump system but not yet acted in the user; and

the previous food component is based upon previous food intake that has not yet metabolized in the user;

storing a calculated value for the total insulin load and a time value for the particular time in a computer-readable memory device of the medical infusion pump system; and

displaying the calculated value for the total insulin load on the display device of the medical infusion pump system.

15. The method of claim 14, wherein displaying the calculated value for the total insulin load on the display device comprises contemporaneously displaying the glucose value indicative of the blood glucose level of the user and the calculated value for the total insulin load.

16. The method of claim 14, further comprising providing plot data to at least partially define a time-based plot of calculated values for total insulin load versus time.

17. The method of claim 16, further comprising displaying the time-based plot of calculated values for total insulin load versus time on the display device of the medical infusion pump system.

18. The method of claim 16, wherein the plot data is exported to an external computer system to display the time-based plot of calculated values for total insulin load versus time on a display device of the external computer system.

19. The method of claim 14, further comprising receiving glucose information from the monitoring device of the medical infusion pump system, the glucose information being indicative of a detected blood glucose level of the user.

20. The method of claim 19, further comprising displaying the glucose value indicative of the detected blood glucose level of the user on the display device of the portable infusion pump system, wherein the display device contemporaneously displays the glucose value and the calculated value for the total insulin load.

21. A method of operating the medical infusion pump system of claim 1, comprising:

receiving user input indicative of a request to suggest a bolus dosage;

receiving user input indicative of a proposed food intake to be consumed by a user of the medical infusion pump system;

receiving glucose information indicative of a glucose level of the user;

determining a bolus suggestion value according to a function that includes the total insulin load of the user, wherein the total insulin load accounts for (i) a bolus insulin load indicative of one or more bolus insulin dosages that have been dispensed into the user but not yet acted in the user, (ii) a basal insulin load indicative of one or more basal insulin dosages that have been dispensed into the user from the medical infusion pump system but not yet acted in the user; and

(iii) a previous food component based upon previous food intake that has not yet metabolized in the user; and

displaying the bolus suggestion value on the display device of the medical infusion pump system.

22. The method of claim 21, wherein further comprising prompting the user initiate a bolus dosage in the amount of the suggested bolus value displayed on the display device.

23. The method of claim 21, wherein the bolus suggestion value is determined according to the function:

24. The method of claim 23, wherein the proposed food intake bolus is determine according to:

(estimated value of carbohydrates to be consumed)×

(carbohydrate ratio).

25. The method of claim 23, wherein the correction bolus is determine according to:

(the glucose level of the user−

a target glucose level)×

(an insulin sensitivity factor).

26. The method of claim 23, wherein the total insulin load of the user at time t_n is determine according to:

(bolus insulin load at time t_n)+(basal insulin load at time t_n)−

(previous food component at time t_n).

2. A medical infusion pump system, comprising:

a portable pump housing that receives insulin for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense the insulin through a flow path to the user;

a controller that activates the pump drive system to dispense the insulin from the portable pump housing;

a monitoring device that communicates glucose information to the controller, the glucose information being indicative of a blood glucose level of the user; and

a user interface coupled to the controller including a display device that contemporaneously displays a glucose value indicative of the blood glucose level of the user and a total insulin load indicative of bolus and basal insulin dosages that have dispensed but not yet acted in the user, and the display device contemporaneously displays the glucose value and the total insulin load in a reference information screen that is displayed when the user has not activated any menu options for a particular period of time.

27. The system of claim 2, wherein the total insulin load is determined by the controller according to a function that accounts for (i) a bolus insulin load indicative of one or more bolus insulin dosages that have been dispensed into the user but not yet acted in the user, (ii) a basal insulin load indicative of one or more basal insulin dosages that have been dispensed into the user from the portable infusion pump system but not yet acted in the user;

and (iii) a previous food component based upon previous food intake that has not yet metabolized in the user.

28. The system of claim 2, further comprising a computer-readable memory device coupled to the controller that stores one or more calculated values for the total insulin load and one or more corresponding time values.

29. The system of claim 2, wherein the controller comprises a controller housing that removably attaches to the pump housing, the controller being electrically connected to the pump drive system when the controller housing is removably attached to the pump housing.

30. The system of claim 2, wherein the portable pump housing receives a prefilled cartridge of the insulin through an opening in the pump housing that is coverable with a cap device, and the flow path of the insulin comprises and an infusion set tube that extends from the cap device to the user.

31. The system of claim 2, wherein the monitoring device comprises a portable housing wearable on the user'"'"'s skin, a sensor shaft that penetrates into the user'"'"'s skin, and a wireless communication device to transmit the glucose information to a wireless communication device of the controller.

13. A medical infusion pump system, comprising:

a portable pump housing that receives insulin for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense the insulin through a flow path to the user;

a controller that activates the pump drive system to dispense the insulin from the portable pump housing;

a monitoring device that communicates glucose information to the controller, the glucose information being indicative of a blood glucose level of the user, wherein the monitoring device comprises a portable housing wearable on the user'"'"'s skin, a sensor shaft that penetrates into the user'"'"'s skin, and a wireless communication device to transmit the glucose information to a wireless communication device of the controller; and

a user interface coupled to the controller including a display device that contemporaneously displays a glucose value indicative of the blood glucose level of the user and a total insulin load indicative of bolus and basal insulin dosages that have dispensed but not yet acted in the user.

32. The system of claim 13, wherein the total insulin load is determined by the controller according to a function that accounts for (i) a bolus insulin load indicative of one or more bolus insulin dosages that have been dispensed into the user but not yet acted in the user, (ii) a basal insulin load indicative of one or more basal insulin dosages that have been dispensed into the user from the portable infusion pump system but not yet acted in the user;

and (iii) a previous food component based upon previous food intake that has not yet metabolized in the user.

33. The system of claim 13, further comprising a computer-readable memory device coupled to the controller that stores one or more calculated values for the total insulin load and one or more corresponding time values.

34. The system of claim 13, wherein the controller comprises a controller housing that removably attaches to the pump housing, the controller being electrically connected to the pump drive system when the controller housing is removably attached to the pump housing.

35. The system of claim 13, wherein the portable pump housing receives a prefilled cartridge of the insulin through an opening in the pump housing that is coverable with a cap device, and the flow path of the insulin comprises and an infusion set tube that extends from the cap device to the user.