Infusion Pump System and Methods

• US 20100174266A1
• Filed: 01/02/2009
• Published: 07/08/2010
• Est. Priority Date: 01/02/2009
• Status: Active Grant

• Current Assignee: Insulet Corporation, M2 Medical Group Holdings, Inc.
• Original Assignee: M2 Medical Group Holdings, Inc.
• Inventors: Estes, Mark C.
• Granted Patent: US 8,974,439 B2
• Time in Patent Office: Days
• US Class Current: 604/504
• 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 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• 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 5/1456 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 provide a suggested bolus dosage based on particular parameters (e.g., the user'"'"'s recent blood glucose characteristics, food intake data, an amount of insulin already delivered to the user which has not yet acted on the user, or other factors). In some circumstances, the infusion pump system can receive information indicative of the user'"'"'s blood glucose level and suggest an insulin bolus dosage that is at least partially dependent upon the recent rate of change in the user'"'"'s blood glucose level. Such a feature can be helpful to a user when the infusion pump is operated in conjunction with a glucose monitoring device because the suggested bolus dosage can be at least partially based on recent data indicative of the user'"'"'s blood glucose level.

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 communicates with the pump drive system to dispense the insulin from the portable pump housing; and

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 controller displays a suggested bolus dosage in response to user input, the suggested bolus dosage being at least partially dependent upon both the blood glucose level of the user and a rate of change to the blood glucose level of the user.

2. The system of claim 1, wherein the controller device determines the suggested bolus dosage in response to user input of food intake information.

3. The system of claim 1, wherein the controller determines the suggested bolus dosage based on the blood glucose level of the user, a rate of change to the blood glucose level of the user, user input of food intake information, and an estimate of an amount of insulin already delivered to the user which has not yet acted on the user.

4. The system of claim 2, wherein the controller determines the suggested bolus dosage according to the function:

Suggested Bolus Dosage=(Food Offsetting Component)+(Blood Glucose Correction Component)−

(Insulin Load Correction Component).

5. The system of claim 3, wherein the controller determines the Blood Glucose Correction Component according to the function:

Blood Glucose Correction Component=(Current Blood Glucose Level−

Target Glucose Level)*(Insulin Sensitivity)*[1+(Rate of Change*Scaling Factor)], where Rate of Change represents a recent rate of change in the user'"'"'s blood glucose level.

6. The system of claim 1, wherein the controller determines the suggested bolus dosage in accordance with a function that implements different weights for the rate of change to the blood glucose level of the user.

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

8. The system of claim 7, wherein the display device contemporaneously displays the suggested bolus dosage, the blood glucose level of the user, and an indication that the rate of change in the blood glucose level in increasing or decreasing.

9. The system of claim 8, wherein the controller the communicates with the pump drive system to dispense the suggested bolus dosage to the user in response to actuation of at least one of the buttons.

10. The system of claim 1, wherein the controller comprises a controller housing that removably attaches to the pump housing.

11. The system of claim 9, wherein the controller is electrically connected to the pump drive system when the controller housing is removably attached to the pump housing.

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

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

14. The system of claim 1, 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.

15. A method of operating an insulin infusion pump system, comprising:

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

in response to receiving user input indicative of a quantity of food intake, determining a suggested bolus dosage according to a function that is at least partially dependent upon (i) the user input indicative of a quantity of food intake, (ii) the blood glucose level of the user, and (iii) a rate of change in the blood glucose level of the user;

displaying on a display screen the suggested bolus dosage, the blood glucose level of the user, and an indication that the rate of change in the blood glucose level in increasing or decreasing; and

dispensing the suggested bolus dosage in accordance with a predetermined protocol in response to a user command.

16. The method of claim 15, further comprising prompting the user to initiate a bolus dosage in the amount of the suggested bolus value displayed on the display device.

17. The method of claim 15, wherein the suggested bolus dosage is determined according to the function:

Suggested Bolus Dosage=(Food Offsetting Component)+(Blood Glucose Correction Component)−

(Insulin Load Correction Component).

18. The method of claim 17, wherein the Blood Glucose Correction Component according to the function:

Blood Glucose Correction Component=(Current Blood Glucose Level−

Target Glucose Level)*(Insulin Sensitivity)*[1+(Rate of Change*Scaling Factor)], where Rate of Change represents a recent rate of change in the user'"'"'s blood glucose level.

19. The method of claim 18, wherein the Scaling Factor is weighted depending on the direction or magnitude of the rate of change in the user'"'"'s blood glucose level.

20. A portable insulin pump system, comprising:

a disposable and non-reusable pump device including;

a pump housing that defines a space to receive an insulin cartridge; and

a drive system to dispense insulin when the insulin cartridge is received by the pump housing, the drive system including a piston rod that is incrementally movable to apply a dispensing force; and

a removable controller device including;

a controller housing that is removably attachable to the pump housing in a fixed relationship to provide an electrical connection between the controller device and the pump device;

control circuitry arranged in the controller housing to electrically communicate with the drive system in the pump housing;

a user interface connected to the control circuitry, the user interface including a display and one or more user-selectable buttons; and

a wireless communication device to receive glucose information from a wearable monitoring device, the glucose information being indicative of a blood glucose level of the user,

wherein the removable controller device displays a suggested bolus dosage in response to user input to the user interface, the suggested bolus dosage being at least partially dependent upon both the blood glucose level of the user and a rate of change to the blood glucose level of the user.