Infusion pump systems and methods

• US 10,737,015 B2
• Filed: 04/09/2018
• Issued: 08/11/2020
• Est. Priority Date: 08/20/2008
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Estes, Mark C.
• Primary Examiner(s): Bouchelle, Laura A
• Application Number:
  US15/948,356
• Publication Number:
  US 20180221567A1
• Time in Patent Office: 855 Days
• 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, wherein the controller is configured to receive glucose information being indicative of a blood glucose level of the user; and

an external computer including a display in wireless communication with the controller;

wherein the system determines a total insulin load 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.

2. The system of claim 1, wherein the function further accounts for a previous food component based upon previous food intake that has not yet metabolized in the user.

3. The system of claim 1, wherein the system displays to a user a glucose value indicative of the blood glucose level of the user and the total insulin load.

4. The system of claim 3, wherein the glucose value and the total insulin load are contemporaneously displayed to the user.

5. The system of claim 1, wherein the total insulin load is determined by the controller.

6. 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.

7. 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.

8. The system of claim 1, wherein the controller is a reusable device, and wherein the pump housing and pump drive system are components of a disposable and nonreusable pump device having one or more structures that hinder reuse of the pump device after a supply of the insulin is exhausted.

9. The system of claim 1, wherein the portable pump housing receives a prefilled cartridge through an opening of the pump housing that is coverable with a cap device.

10. The system of claim 9, wherein the flow path of the insulin comprises an infusion set tube that extends from the cap device to the user.

11. The system of claim 1, wherein the total insulin load is determined based on a user input request.

12. The system of claim 1, wherein the total insulin load is automatically determined at predetermined intervals.

13. The system of claim 1, wherein the total insulin load is a normalized total insulin load (TIL) percentage value, determined according to the function:

total insulin load percentage=[(Actual TIL)−

(theoretical TIL_basal)]/(theoretical TIL_basal)×

100

where theoretical TIL_basal represents the TIL that would have been generated based only on the user'"'"'s basal insulin dosages.

14. The system of claim 1, wherein the system alerts the user when the total insulin load is a negative value.

15. The system of claim 1, wherein the system alerts the user when the total insulin load increases at a rate above a predetermined rate indicative of a potentially unsafe condition.

16. The system of claim 1, wherein the total insulin load is a numerical value that is displayed to the user.