Infusion Pump System and Methods

• US 20180093039A1
• Filed: 11/14/2017
• Published: 04/05/2018
• Est. Priority Date: 10/15/2008
• Status: Abandoned Application

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Estes, Mark C.
• Application Number:
  US15/811,909
• Publication Number:
  US 20180093039A1
• Time in Patent Office: Days
• 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. (canceled)

2. A medical infusion pump system, comprising:

a glucose monitoring device; and

an infusion pump in wireless communication with the glucose monitoring device, the infusion pump 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, the controller being configured to calculate a total insulin load of the user representing an estimated amount of bolus and basal insulin delivered to the user'"'"'s body which has not yet acted, wherein the controller outputs an alarm based on an analysis of glucose information received from the glucose monitoring device in comparison to the total insulin load.

3. The system of claim 2, wherein the pump housing comprises a disposable pump body and the controller comprises a reusable controller, the disposable pump body being configured to reversibly connect with the reusable controller.

4. 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 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.

5. The system of claim 4, wherein the function further accounts for (iii) a previous food component based upon previous food intake that has not yet metabolized in the user.

6. The system of claim 2, wherein the infusion pump further comprises a computer-readable memory device coupled to the controller that stores the glucose information received from the glucose monitoring device and time values associated with the glucose information.

7. The system of claim 2, wherein the glucose 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.

8. The system of claim 2, 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, the upper and lower glucose alarm limit parameters being adjusted based on the total insulin load.

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

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

11. The system of claim 8, further comprising a user interface, 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.

12. The system of claim 11, wherein the display device contemporaneously displays a glucose value indicative of the blood glucose level of the user and a calculated total insulin load value indicative of estimated amount of insulin delivered to the user'"'"'s body which has not yet acted.

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 a total insulin load of the user indicative of an estimated amount of bolus and basal insulin delivered to the user'"'"'s body which has not yet acted; and

outputting an alarm based on an analysis of the glucose information and the total insulin load.

14. The method of claim 13, further comprising activating a pump drive system to dispense the bolus and basal 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.

16. The method of claim 13, wherein the total insulin load is determined 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 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.

17. The method of claim 16, wherein the function further accounts for (iii) a previous food component based upon previous food intake that has not yet metabolized in the user.