Operating an Infusion Pump System

• US 20140249500A1
• Filed: 03/01/2013
• Published: 09/04/2014
• Est. Priority Date: 03/01/2013
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Asante Solutions, Inc
• Inventors: Estes, Mark C.
• Granted Patent: US 9,446,186 B2
• Time in Patent Office: Days
• US Class Current: 604/504
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/8206 battery-operated
• 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 5/14566 with a replaceable reservoir for receiving a piston rod of the pump

Abstract

Some embodiments of an infusion pump system can be configured to provide improved safety monitoring features so that a user receives proper dosage amounts.

Claims

1. An insulin infusion pump system, comprising:

a portable housing defining a space to receive a supply of insulin;

a pump drive system to dispense insulin from the portable housing when the insulin is received in the space;

control circuitry that electrically communicates with the pump drive system to control dispensation of the insulin from the portable housing when the insulin is received in the space; and

a user interface connected to the control circuitry and configured to receive user input of a value for a first user-specific setting, wherein the control circuitry is configured to output an alert via the user interface in response to user input of the value for the first user-specific setting that is outside of a predetermined range dependent at least partially upon a previously stored value for a second user-specific setting that is different from the first user-specific setting.

2. The system of claim 1, wherein the alert output via the user interface comprises a textual alert message indicating that the input value for the first user-specific setting is out of balance with the previously stored value for the second user-specific setting.

3. The system of claim 2, wherein the first user-specific setting is one selected from the group consisting of:

a user'"'"'s insulin sensitivity, a user'"'"'s carbohydrate ratio, a user'"'"'s scheduled basal dosage amount, and a user'"'"'s weight, and wherein the second user-specific setting is a different one selected from the group consisting of;

the user'"'"'s insulin sensitivity, the user'"'"'s carbohydrate ratio, the user'"'"'s scheduled basal dosage amount, and the user'"'"'s weight.

4. The system of claim 1, wherein the control circuitry is configured to prompt the user to select a first option via the user interface indicative of an instruction to continue with the value for the first user-specific setting or to select a second option via the user interface indicative of an instruction to provide a new value for the first user-specific setting, wherein the first option and second option are contemporaneously displayed via the user interface.

5. The system of claim 4, wherein in response to user selection of the first option via the user interface, the control circuitry is configured to store the input the value for the first user-specific setting in a memory device of the control circuitry.

6. The system of claim 4, wherein in response to user selection of the second option via the user interface, the control circuitry is configured to prompt the user to input the new value for the first user-specific setting via the user interface.

7. The system of claim 1, wherein the portable housing comprises a pump housing of a portable pump device, and wherein the control circuitry is housed in a controller housing of a removable controller device that is releasably attachable to the pump housing to establish an electrical connection between the controller device and the pump device, the user interface being mounted to the controller housing.

8. The system of claim 1, wherein the pump drive system and the control circuitry are housed inside the portable housing, and the user interface is mounted to the portable housing.

9. A medical infusion pump system, comprising:

a portable housing defining a space to receive a supply of medicine;

a pump drive system to dispense medicine from the portable housing when the medicine is received in the space;

control circuitry that electrically communicates with the pump drive system to control dispensation of the medicine from the portable housing when the medicine is received in the space, the control circuitry including one or more computer readable memory devices storing values for user-specific settings and pump usage parameters; and

a user interface connected to the control circuitry and having a display screen, wherein the control circuitry is configured to output an alert via the user interface in response a stored value for a first one of the user-specific settings and the pump usage parameters being outside of a predetermined range that is dependent at least partially upon a stored value for a second one of the user-specific settings and the pump usage parameters.

10. The system of claim 9, wherein the alert output via the user interface comprises a textual alert message indicating that the stored value for the first one of the user-specific settings and the pump usage parameters is out of the predetermined range.

11. The system of claim 10, wherein the user-specific settings stored in the one or more memory devices of the control circuitry includes at least one of:

a user'"'"'s insulin sensitivity, a user'"'"'s carbohydrate ratio, a user'"'"'s scheduled basal dosage amount, and a user'"'"'s weight, and wherein the pump usage parameters stored in the one or more memory devices of the control circuitry includes at least one of;

an average total daily dose, an average total basal dose per day, an average total bolus dose per day, a ratio of correction bolus amount per day to food bolus amount per day, an amount of correction boluses per day, a ratio of a correction bolus amount per day to the average total daily dose, a ratio of the average total basal dose to the average total bolus dose, an average maximum bolus per day, a frequency of using an auto-off alarm per day, and a frequency of cannula prime operations and tube prime operations per day.

12. The system of claim 9, wherein the control circuitry is configured to prompt the user via the display of the user interface to take a correction action selected from the group consisting of:

input a new value for one of the user-specific settings, input a new parameter for a dosage schedule, and review troubleshooting instructions.

13. The system of claim 9, wherein the portable housing comprises a pump housing of a portable pump device, and wherein the control circuitry is housed in a controller housing of a removable controller device that is releasably attachable to the pump housing to establish an electrical connection between the controller device and the pump device, the user interface being mounted to the controller housing.

14. The system of claim 9, wherein the pump drive system and the control circuitry are housed inside the portable housing, and the user interface is mounted to the portable housing.

15. An insulin infusion pump system, comprising:

a portable housing defining a space to receive a supply of insulin;

a pump drive system to dispense insulin from the portable housing when the insulin is received in the space;

control circuitry that electrically communicates with the pump drive system to control dispensation of the insulin from the portable housing when the insulin is received in the space, the control circuitry being configured to receive blood glucose information over a period of time; and

a user interface connected to the control circuitry and having a display screen, the user interface being configured to receive user input to initiate a bolus dosage of the insulin, wherein the control circuitry outputs an alert via the user interface in response to the control circuitry detecting an infusion set error based at least in part upon the blood glucose information received by the control circuitry over the period of time.

16. The system of claim 15, wherein the alert output via the user interface comprises a textual alert message indicating the infusion set error, and wherein the control circuitry detects the infusion set error in response to a determination by the control circuitry that the blood glucose information indicates that a user'"'"'s blood glucose level is not decreasing over a predetermined period of time after initiating the bolus dosage.

17. The system of claim 15, wherein the alert output via the user interface comprises a textual alert message indicating the infusion set error, and wherein the control circuitry detects the infusion set error in response to a determination by the control circuitry that the blood glucose information indicates that a rate of change of a user'"'"'s blood glucose level is not decreasing over a predetermined period of time after initiating the bolus dosage.

18. A method of operating a portable infusion pump system:

dispensing medicine from a portable housing of an infusion pump system; and

receiving user input at a user interface of the infusion pump system indicative of a value for a first user-specific setting;

outputting an alert via the user interface of the infusion pump system in response to a determination by the infusion pump system that the user input of the value for the first user-specific setting that is outside of a predetermined range dependent at least partially upon a previously stored value for a second user-specific setting that is different from the first user-specific setting.

19. A method of operating a portable infusion pump system:

dispensing medicine from a portable housing of an infusion pump system; and

storing values for user-specific settings and pump usage parameters in one or more computer readable memory devices of control circuitry of the infusion pump system; and

outputting an alert via a user interface of the infusion pump system in response a stored value for a first one of the user-specific settings and the pump usage parameters being outside of a predetermined range that is dependent at least partially upon a stored value for a second one of the user-specific settings and the pump usage parameters.

20. A method of operating a portable infusion pump system:

dispensing medicine from a portable housing of an infusion pump system; and

receiving user input at a user interface of the infusion pump system to initiate a bolus dosage of the medicine;

receiving at the infusion pump system blood glucose information indicative of a user'"'"'s blood glucose measurements over a period of time; and

outputting an alert via the user interface of the infusion pump system in response to the infusion pump system detecting an infusion set error based at least in part upon the blood glucose information received by the infusion pump system over the period of time.

21. An insulin infusion pump system, comprising:

a portable housing defining a space to receive a supply of insulin;

a pump drive system to dispense insulin from the portable housing when the insulin is received in the space;

control circuitry that electrically communicates with the pump drive system to control dispensation of the insulin from the portable housing when the insulin is received in the space; and

a user interface connected to the control circuitry and having a display screen, the user interface being configured to receive user input for a value of a first user-specific setting, wherein the control circuitry generates values for a set of user-specific settings that are different from the first user-specific setting in response to the user input for the value of the first user-specific setting.

22. The system of claim 21, wherein the first user-specific setting is selected from the group consisting of:

a total daily dosage based on a previous history of insulin injections, a total daily dosage based on the a previous history of pump usage, and a total daily basal dosage based on the previous history of pump usage, and wherein the control circuitry generates values for the set of user-specific settings including two or more selected from the group consisting of;

a basal rate, a maximum basal rate, a maximum bolus dosage, an insulin sensitivity, and a carb ratio.