Infusion pump system and methods

• US 9,114,210 B2
• Filed: 09/13/2012
• Issued: 08/25/2015
• Est. Priority Date: 10/15/2008
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Estes, Mark C.
• Primary Examiner(s): Gilbert, Andrew
• Application Number:
  US13/613,846
• Publication Number:
  US 20130053819A1
• Time in Patent Office: 1,076 Days
• Field of Search: 604/890.1, 604/504, 604 65- 67, 604/131, 604/151
• US Class Current: 1/1
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• 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 2205/18 with alarm
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• 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 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• 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

Abstract

Some embodiments an infusion pump system can be configured to modify alarm limit parameters as the user'"'"'s insulin load increases or decreases. Moreover, in particular embodiments, the infusion pump system can be configured to provide a “missed bolus” or “missed meal” alarm in response to the user'"'"'s blood glucose characteristics, the user'"'"'s insulin load information, or the like.

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; and

a controller that communicates with the pump drive system to dispense the insulin from the portable pump housing, the controller being configured to calculate an insulin load of the user representing an estimated amount of insulin delivered to the user'"'"'s body which has not yet acted,

wherein the controller receives glucose information indicative of a detected blood glucose level of the user, and wherein the controller outputs an alarm when the glucose information indicates that the detected blood glucose level reaches beyond a glucose alarm limit parameter, the glucose alarm limit parameter being adjustable by the controller in response to the insulin load of the user representing the estimated amount of insulin delivered to the user'"'"'s body which has not yet acted.

2. The system of claim 1, wherein the insulin load of the user is calculated as 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 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.

4. The system of claim 1, further comprising a monitoring device that communicates the glucose information to the controller, and a computer-readable memory device coupled to the controller that stores the glucose information received from the monitoring device and time values associated with the glucose information.

5. The system of claim 4, 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.

6. The system of claim 1, wherein the controller outputs the alarm when the glucose information indicates that the blood glucose level increases above an upper glucose alarm limit parameter or decreases below a lower glucose alarm limit parameter.

7. The system of claim 1, wherein the controller increases the glucose alarm limit parameter when the user'"'"'s insulin load is calculated to be greater than a predetermined insulin load range.

8. The system of claim 7, wherein the controller decreases the glucose alarm limit parameter when the user'"'"'s insulin load is calculated to be lower than a predetermined insulin load range.

9. The system of claim 1, further comprising a user interface coupled to the controller, the user interface including a display device that indicates when the glucose alarm limit parameter is adjusted by the controller in response to the insulin load of the user.

10. The system of claim 9, wherein the display device contemporaneously displays a glucose value indicative of the blood glucose level of the user and a calculated insulin load value indicative of estimated amount of insulin delivered to the user'"'"'s body which has not yet acted.

11. The system of claim 1, wherein the glucose alarm limit parameter is dynamically changed over time by the controller as the insulin load of the user increases or decreases.

12. The system of claim 1, wherein the insulin load of the user represents a sum of bolus dosages delivered to the user within a predetermined period of time.

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

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

determining an insulin load of the user indicative of an estimated amount of insulin delivered to the user'"'"'s body which has not yet acted;

in response to the determination of said insulin load of the user indicative of said estimated amount of insulin delivered to the user'"'"'s body which has not yet acted, modifying at least one of an upper alarm limit parameter and a lower alarm limit parameter; and

outputting an alarm when the glucose information indicates that the detected blood glucose level is greater than the modified upper alarm limit parameter or is less than the modified lower alarm limit parameter.

14. The method of claim 13, further comprising activating a pump drive system to dispense the insulin through a flow path to the user.

15. The method of claim 13, wherein receiving the glucose information comprises receiving a signal from a wireless glucose monitoring device wearable on the user'"'"'s body.