Method and system for providing integrated medication infusion and analyte monitoring system

• US 8,029,459 B2
• Filed: 12/21/2009
• Issued: 10/04/2011
• Est. Priority Date: 03/21/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Reggiardo, Christopher V., Rush, Benjamin M.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Hall; Deanna K
• Application Number:
  US12/643,970
• Publication Number:
  US 20100100076A1
• Time in Patent Office: 652 Days
• Field of Search: 604 65- 67, 604/503
• US Class Current: 604/65
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

Method and system for integrating infusion device and analyte monitoring system including medication infusion device such as an insulin pump and an analyte monitoring system such as a glucose monitoring system are provided.

Claims

1. An integrated therapy system, comprising:

an analyte monitor unit including;

a compact housing;

a user interface operatively coupled to the housing;

a strip port operatively coupled to the housing and configured to receive a glucose test strip;

a data processing section comprising a processor and memory, the data processing section operatively coupled to the housing and configured to receive a plurality of signals associated with a monitored analyte level from a remote location, and the memory having instructions stored which, when executed by the processor, determines a glucose concentration based on a fluid sample on the glucose test strip; and

an infusion device configured for wireless communication with the analyte monitor unit;

wherein the memory having instructions stored which, when executed by the processor, causes the infusion device to execute a pre-programmed basal profile that includes a plurality of predetermined discrete medication infusions temporally separated by a predetermined time period;

wherein the memory having instructions stored which, when executed by the processor, modifies the pre-programmed basal profile based on the fluid sample and the monitored analyte level; and

wherein the memory having instructions stored which, when executed by the processor, obtains at least one of the plurality of signals associated with the monitored analyte level substantially immediately prior to each predetermined discrete medication infusion.

2. The system of claim 1 wherein the memory having instructions stored which, when executed by the processor, controls the operation of the infusion device.

3. The system of claim 1 wherein the user interface of the analyte monitoring unit provides access to the user to control the infusion device.

4. The system of claim 1 wherein the analyte monitor unit determines a bolus dose based at least in part on the determined glucose concentration.

5. The system of claim 4 wherein the infusion device is configured to execute the determined bolus dose.

6. The system of claim 4 wherein the bolus dose includes one or more of a correction bolus, a carbohydrate bolus, an extended bolus, or a dual bolus.

7. The system of claim 4 wherein the analyte monitor unit is configured to determine the bolus dose based on one or more of an insulin sensitivity information, an insulin on board information, an intended carbohydrate intake information, a determined glucose level, or a glucose trend information.

8. The system of claim 1 wherein the infusion device includes an insulin pump.

9. The system of claim 1 wherein the infusion device is configured to deliver a medication based on an infusion rate in response to a signal received from the analyte monitor unit.

10. The system of claim 9 wherein the medication includes insulin.

11. The system of claim 1 wherein the determined glucose concentration is output on the user interface of the analyte monitor unit.

12. The system of claim 1 wherein the memory having instructions stored which, when executed by the processor, transmits the determined glucose concentration to the infusion device.

13. The system of claim 1 wherein a parameter associated with the operation of the infusion device provided in the analyte monitor unit includes a predetermined alarm condition associated with the infusion device.

14. The system of claim 1 wherein a parameter associated with the operation of the infusion device includes an occlusion condition.

15. The system of claim 1 wherein the remote location includes a transmitter in signal communication with a subcutaneously positioned analyte sensor.

16. The system of claim 15 wherein the analyte sensor includes a glucose sensor.

17. The system of claim 15 wherein at least a portion of the analyte sensor is maintained in fluid contact with an interstitial fluid under a skin surface.

18. The system of claim 15 wherein the transmitter is configured to wirelessly communicate with the analyte monitor unit.

19. The system of claim 15 wherein the memory having instructions stored which, when executed by the processor, causes the transmitter to transmit a plurality of sampled data signals from the analyte sensor at a predetermined transmission rate.

20. The system of claim 19 wherein the predetermined transmission rate includes approximately one minute transmission interval.

21. The system of claim 19 wherein the memory having instructions stored which, when executed by the processor, encodes the plurality of sampled data signals prior to transmission.

22. The system of claim 21 wherein the memory having instructions stored which, when executed by the processor, decodes the received plurality of sampled data signals received from the transmitter.

23. The system of claim 1 wherein the user interface is configured to output data associated with the plurality of signals associated with the monitored analyte level.

24. The system of claim 1 wherein the user interface includes a display coupled to the housing.

25. The system of claim 1 wherein the analyte monitor unit and the infusion device are configured for bi-directional communication.

26. The system of claim 1 wherein the data processing section further comprises a transimpedance amplifier.

27. The system of claim 26 wherein the transimpedance amplifier comprises at least two operational amplifiers, at least four resistors, and at least one capacitor.