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

• US 20060224141A1
• Filed: 03/21/2006
• Published: 10/05/2006
• Est. Priority Date: 03/21/2005
• Status: Abandoned Application

• 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.
• Application Number:
  US11/386,915
• Publication Number:
  US 20060224141A1
• Time in Patent Office: Days
• US Class Current: 604/503
• 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. A system including an infusion device and an analyte monitoring unit, comprising:

an infusion device;

an on-body unit including a data transmission section, the on-body unit further coupled to the infusion device, the on-body unit configured to receive one or more signals corresponding to a respective one or more analyte levels, and further, the on-body unit configured to infuse a fluid received from the infusion device; and

a receiver unit operatively coupled to the on-body unit, the receiver unit configured to receive data from the on-body unit, wherein the received data is associated with the analyte level.

2. The system of claim 1 further including an analyte sensor at least a first portion of which is in fluid contact with an analyte of a patient, and further, wherein at a second portion of the analyte sensor is in signal communication with the data transmission section.

3. The system of claim 1 wherein the data transmission section is configured to transmit the one or more signals corresponding to a respective one or more analyte levels substantially periodically at one or more predetermined time intervals.

4. The system of claim 3 wherein the one or more predetermined time intervals includes one or more of 30 seconds, one minute, or 90 seconds.

5. The system of claim 1 wherein the on-body unit includes a cannula at least a portion of which is subcutaneously positioned under a skin layer.

6. The system of claim 5 further including an infusion tubing connected to the infusion device to deliver the fluid to the on-body unit.

7. The system of claim 6 wherein the infusion tubing and the on-body unit are connected in a substantially water tight seal.

8. The system of claim 6 wherein the infusion tubing is configured to operatively couple to the cannula to deliver the fluid.

9. The system of claim 1 wherein the on-body unit is configured to wirelessly transmit the one or more signals corresponding to the respective one or more analyte levels to the receiver unit.

10. The system of claim 9 wherein the on-body unit and the receiver are configured to wirelessly communicate over one or more of an RF communication link, a Bluetooth communication link, or an infrared communication link.

11. The system of claim 1 wherein the infusion device is configured to control the delivery rate of the fluid based on the one or more signals corresponding to the respective one or more analyte levels received by the receiver unit.

12. The system of claim 11 wherein the infusion device is configured to determine a modified delivery protocol for delivering fluid based on information associated with the one or more signals corresponding to the respective one or more analyte levels.

13. The system of claim 12 wherein the fluid is insulin.

14. The system of claim 13 wherein the modified delivery protocol includes one or more of a correction bolus, a modified basal profile, a carbohydrate bolus, an extended bolus, or combinations thereof

15. The system of claim 1 wherein the receiver unit is configured to wirelessly communicate with the infusion device.

16. The system of claim 1 wherein the receiver unit is integrated into a housing of the infusion device.

17. A method of integrating analyte monitoring and fluid infusion, comprising:

infusing a fluid at a predetermined delivery rate;

detecting one or more analyte levels;

transmitting one or more signals associated with the respective detected one or more analyte levels; and

determining a modified delivery rate based on the transmitted one or more signals.

18. The method of claim 17 wherein the fluid is insulin.

19. The method of claim 17 wherein the one or more signals are transmitted substantially immediately after the associated respective one or more analyte levels are detected.

20. The method of claim 17 wherein the transmitting step includes wirelessly transmitting the one or more signals.

21. The method of claim 20 wherein the one or more signals are wirelessly transmitted over one or more of an RF communication link, a Bluetooth communication link, an infrared communication link, or combinations thereof

22. The method of claim 17 further including the steps of:

receiving the transmitted one or more signals; and

displaying the received one or more signals.

23. The method of claim 17 further including the step of displaying the modified delivery rate.

24. The method of claim 17 further including the step of implementing the modified delivery rate.

25. The method of claim 17 wherein the predetermined delivery rate includes one or more basal delivery rates.

26. The method of claim 17 wherein the modified delivery rate includes one or more of a correction bolus, a modified basal profile, a carbohydrate bolus, an extended bolus, or combinations thereof

27. An apparatus including an analyte sensor and a fluid delivery channel, comprising:

a fluid delivery unit having an inner wall and an outer wall; and

a plurality of electrodes disposed between the inner wall and the outer wall of the fluid delivery unit;

wherein a portion of the of the fluid delivery unit and a portion of the plurality of electrodes are subcutaneously positioned under a skin layer.

28. The apparatus of claim 27 wherein the plurality of electrodes comprise an analyte sensor.

29. The apparatus of claim 27 wherein the plurality of electrodes include one or more of a working electrode, a counter electrode, a reference electrode, or combinations thereof

30. The apparatus of claim 27 wherein the fluid delivery unit is including a channel for delivering a fluid, the channel substantially formed by the inner wall.

31. The apparatus of claim 30 wherein the fluid is insulin.

32. The apparatus of claim 27 wherein at least a portion of the plurality of electrodes is in fluid contact with an analyte.

33. An apparatus including an analyte sensor and a fluid delivery channel, comprising:

a first tubing having a first tubing channel; and

a second tubing having a second tubing channel including a plurality of electrodes disposed within the second tubing channel;

wherein at least a portion of the first tubing and at least a portion of the second tubing are subcutaneously positioned under a skin layer.

34. The apparatus of claim 33 wherein each of the plurality of the electrodes are substantially and entirely insulated from each other.

35. The apparatus of claim 33 wherein the first tubing and the second tubing are integrally formed such that an outer surface of the first tubing is substantially in contact with an outer surface of the second tubing.

36. The apparatus of claim 33 wherein the plurality of electrodes comprise an analyte sensor.

37. A system including an infusion device and an analyte monitoring unit, comprising:

an infusion and monitoring device;

an on-body unit including a data transmission section, the on-body unit further coupled to the infusion and monitoring device, the on-body unit configured to receive one or more signals corresponding to a respective one or more analyte levels, and further, the on-body unit configured to infuse a fluid received from the infusion and monitoring device; and

a connector coupled at a first end to the infusion device, and further, coupled at a second end to the on-body unit, the connector configured to channel the fluid from the infusion device to the on-body unit, and further, configured to provide the one or more signals corresponding to the respective one or more analyte levels to the infusion and monitoring device.

38. The system of claim 37 wherein the infusion and monitoring device is configured to execute fluid delivery to a patient, and further, to detect analyte levels of the patient over a predetermined time period.

39. The system of claim 37 wherein the infusion and monitoring device includes a continuous glucose monitoring system.

40. The system of claim 37 wherein the infusion and monitoring device includes an insulin pump.

41. A method of fluid delivery and analyte monitoring, comprising:

determining a delivery profile for fluid infusion, wherein the delivery profile including a plurality of predetermined discrete fluid infusion each temporally separated by a predetermined time period; and

sampling an analyte level substantially immediately prior to each predetermined discrete fluid infusion.

42. The method of claim 41 further including the step of sampling an analyte level substantially immediately after each predetermined discrete fluid infusion.