Operating an infusion pump system

• US 7,717,903 B2
• Filed: 09/06/2007
• Issued: 05/18/2010
• Est. Priority Date: 09/06/2007
• Status: Active Grant

• Current Assignee: Insulet Corporation, M2 Medical Group Holdings, Inc.
• Original Assignee: M2 Group Holdings Inc (Bigfoot Biomedical, Inc.)
• Inventors: Wenger, Mitchell, Estes, Mark C.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US11/851,194
• Publication Number:
  US 20090069745A1
• Time in Patent Office: 985 Days
• Field of Search: 604/67, 604/120, 604/890.1
• US Class Current: 604/890.1
• 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 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/16804 Flow controllers
• 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 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Some embodiments of a portable medical device, such as an infusion pump, can receive an external reference signal (e.g., a radio, cellular and/or satellite signal) to provide an automatic time-setting and maintenance operation. In these circumstances, the medical device can maintain accurate time and date information even in the event of a power interruption, a time-zone change and/or an internal clock error, for example. In this manner, the portable medical device provides safe operation and added convenience to the user.

Claims

1. A method of operating a portable infusion pump system, comprising:

receiving at a portable infusion pump system an external reference clock signal that is broadcast from a remote time reference source, the external reference clock signal being indicative of a standard time and a standard date;

automatically updating at predetermined intervals a time setting of the portable infusion pump system based on the external reference clock signal to provide an updated time, the updated time being presented on a user interface display of the portable infusion pump system;

in response to the updated time setting being different from a previous time setting by a predetermined threshold, alerting a user via the user interface display that the updated time is detected; and

after alerting the user via the user interface display, receiving user input that authorizes a change to an operation of the portable infusion pump system based on the updated time setting.

2. The method of claim 1, wherein the external reference clock signal is broadcast from the remote time reference source that comprises at least one of a transmitter tower, a satellite, and a transmitter base station.

3. The method of claim 1, further comprising:

adjusting a medicine dosage dispensed from the portable infusion pump system based on the updated time setting.

4. The method of claim 2, wherein the external reference clock signal comprises at least one of a cellular telephone time signal and a GPS clock signal.

5. The method of claim 4, further comprising:

indicating a time-zone change based on the external reference clock signal, wherein the step of adjusting the dispensing rate includes shifting the dispensing rate schedule based on the time-zone change.

6. The method of claim 2, further comprising:

storing data in a computer-readable memory of the portable infusion pump system; and

time-stamping the data based on the updated time setting.

7. The method of claim 6, wherein the portable infusion pump system comprises a disposable and non-reusable pump device that is removably attached to a reusable controller device having the user interface display, the reusable controller device including a receiver instrument that receives the external reference signal broadcast from the remote time reference source.

8. The method of claim 2, wherein the step of adjusting the dispensing rate includes periodically altering the dispensing rate based on a time of day.

9. A portable diabetes treatment device, comprising:

an external reference system that receives an external reference signal broadcast from a remote time reference source, the external reference signal being indicative of a standard time and a standard date; and

a controller device that updates a time setting of the portable diabetes treatment device based on the external reference signal to provide an updated time setting,

wherein the controller device operates the portable diabetes treatment device based on the updated time setting.

10. The portable diabetes treatment device assembly of claim 9, wherein the portable diabetes treatment device comprises an insulin pump system including a drive system that dispenses insulin in response to control signals from the controller device, and the controller device adjusts a dispensing rate of the insulin based on the updated time setting.

11. The portable diabetes treatment device of claim 10, wherein the controller device operates the infusion pump system according to a dispensing rate schedule based on a time of day.

12. The portable diabetes treatment device assembly of claim 11, wherein the controller device indicates a time-zone change based on the external reference signal, and shifts the dispensing rate schedule based on the time-zone change.

13. The portable diabetes treatment device of claim 9, further comprising a computer-readable memory device for storing data in the portable diabetes treatment device, wherein the data is time-stamped based on the updated time setting.

14. The portable diabetes treatment device of claim 9, further comprising a display that indicates a time-zone change based on the external reference signal, wherein operation of the portable diabetes treatment device is adjusted based on the time-zone change.

15. A portable diabetes treatment device, comprising:

an external reference system that receives an external reference signal broadcast from a remote time reference source, the external reference signal being indicative of a standard time; and

a controller device that updates a time setting of the portable diabetes treatment device based on the external reference signal to provide an updated time setting, wherein the portable diabetes treatment device comprises a glucose monitoring system that communicates sensor data to the controller device, and the controller device recording the sensor data along with an associated time-stamp based on the updated time setting,

wherein the controller device operates the portable diabetes treatment device based on the updated time setting.

16. The portable diabetes treatment device of claim 15, wherein the external reference signal is indicative of the standard time and a standard date, the external reference system comprising an antenna that receives the external reference signal broadcast from a remote radio transmitter of a radio clock system.

17. The portable diabetes treatment device of claim 15, wherein the glucose monitoring system includes a body-worn glucose sensor device that wirelessly communicates the sensor data to the controller device, the sensor data being indicative of a blood glucose level.

18. The portable diabetes treatment device of claim 17, wherein the controller device includes a user interface display that contemporaneously displays both the blood glucose level and a clock time based upon the updated time setting.

19. The portable diabetes treatment device of claim 18, wherein the controller device that automatically updates the time setting of based on the external reference signal at predetermined intervals of time.

20. A wearable infusion pump system, comprising:

a disposable and non-reusable pump device including a drive system to dispense medicine from the pump device, the pump device having a first electrical connector that is externally accessible;

a reusable controller device removably attachable to the disposable and non-reusable pump device, the controller device comprising;

a second electrical connector that is engageable with the first connector to provide electrical communication between control circuitry of the controller device and the drive system of the pump device;

a user interface comprising a display device, the user interface being electrically connected to the control circuitry

an external reference system that receives an external reference signal broadcast from a remote time reference source, the external reference signal being indicative of a standard time, the external reference system being electrically connected to the control circuitry; and

a processor that updates a time setting of the infusion pump system based on the external reference signal to provide an updated time setting;

wherein the reusable controller activates the drive system of the pump device based on the updated time settings,

wherein the reusable controller device activates the drive system of the pump device according to a dispensing rate schedule based on time of day,

wherein the reusable controller device indicates a time-zone change based on the external reference signal and shifts the dispensing rate schedule based on the time-zone change, and

wherein the user interface queries a user to confirm whether operation of the wearable infusion pump system should be adjusted based on the time-zone change, and wherein the dispensing rate schedule shifting based on the time-zone change is only executed in response to input to the user interface.

21. The wearable infusion pump system of claim 20, wherein the reusable controller device adjusts a dispensing rate of the pump device based on the updated time setting.

22. The wearable infusion pump system of claim 20, wherein the dispensing rate schedule is incrementally shifted to gradually correspond to the time-zone change.

23. The wearable infusion pump system of claim 20, wherein the dispensing rate schedule is step shifted to immediately correspond to the time-zone change.

24. A method of operating a wearable infusion pump system, comprising:

receiving an external reference signal broadcast from a remote time reference source, the external reference signal being indicative of a standard time;

updating a time setting of the wearable infusion pump system based on the external reference signal to provide an updated time;

indicating a time-zone change based on the external reference signal;

querying a user as to whether operation of the wearable infusion pump system should be adjusted due to the time zone change;

in response to user input, adjusting the operation of the wearable infusion pump system based on the time zone change.

25. The method of claim 24, further comprising:

receiving an indication from a user indicating an anticipated time zone change; and

adjusting operation of the wearable infusion pump system based on the anticipated time zone change prior to an actual time zone change.