Analyte monitoring device and methods of use

• US 20060189863A1
• Filed: 11/01/2005
• Published: 08/24/2006
• Est. Priority Date: 04/30/1998
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Heller, Adam, Peyser, Thomas
• Granted Patent: US 8,974,386 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• 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 5/0031 Implanted circuitry
• 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 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units

Abstract

An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the sensor.

Claims

1. An analyte monitoring system, comprising:

a first sensor unit for monitoring an analyte of a patient, at least a portion of the first sensor unit positioned in fluid contact with the analyte of the patient; and

a second sensor unit configured to determine an analyte level of the patient at a predetermined time, data from said second sensor unit configured for calibration of data from said first sensor unit.

2. The system of claim 1, wherein the predetermined time is substantially after one or more of about 10 hours, about 12 hours, about 24 hours and about 48 hours from when the at least the portion of the first sensor unit is first positioned in fluid contact with the analyte.

3. The system of claim 1 wherein the first sensor unit is a subcutaneous sensor.

4. The system of claim 3 further including a blood glucose meter unit, wherein the second sensor unit includes a test strip configured to operatively couple to the blood glucose meter unit.

5. The system of claim 1 further including a blood glucose meter operatively coupled to the second sensor unit.

6. The system of claim 1 further including a transmitter unit operatively coupled to the first sensor unit, the transmitter unit configured to transmit the data from the first sensor unit.

7. The system of claim 1 wherein the first sensor unit includes an analyte sensor.

8. A method of calibrating, comprising the steps of:

positioning at least a portion of a first sensor unit in fluid contact with an analyte of a patient; and

calibrating the first sensor unit after a predetermined time period has lapsed from the positioning step.

9. The method of claim 8 wherein the predetermined time period includes one or more of approximately about a 10 hour period, approximately about a 12 hour period, approximately about a 24 hour period, and approximately about a 48 hour period.

10. The method of claim 8 wherein the calibrating step includes the step of performing a blood glucose measurement after the predetermined time period has lapsed from the positioning step.

11. The method of claim 8 wherein the calibrating step include the step of performing a blood glucose meter test on the patient after the predetermined time period has lapsed from the positioning step.

12. An analyte monitoring system, comprising:

an sensor unit including a sensor, the sensor unit configured to receive a signal corresponding to a level of monitored analyte; and

a display unit operatively coupled to the sensor, the display unit configured to output one or more predetermined sequences of output signals based on signals received from the sensor unit.

13. The system of claim 12 wherein the one or more predetermined sequences of output signals includes a series of audio alerts, a series of vibratory alerts, a series of visual alerts, a series of combination of one or more of audio, visual or vibratory alerts.

14. The system of claim 13 wherein each audio alert in the series of audio alerts is configured to progressively increase or decrease in volume relative to each prior audio alert.

15. The system of claim 13 wherein each vibratory alert in the series of vibratory alerts is configured to progressively increase or decrease in vibratory force relative to each prior vibratory alert.

16. The system of claim 13 wherein each visual alert in the series of visual alerts is configured to progressively increase or decrease in displayed size relative to each prior visual alert.

17. A sensor assembly, comprising:

an analyte sensor configured to detect an analyte level, at least a portion of the analyte sensor including an anticlotting agent; and

a sensor control unit operatively coupled to the analyte sensor for receiving a signal corresponding to the detected analyte level.

18. The assembly of claim 17 wherein the at least the portion of the analyte sensor including the anticlotting agent is configured to be in fluid contact with an analyte.

19. The assembly of claim 17 wherein the anticlotting agent includes at least one of heparin or tissue plasminogen activator.

20. The assembly of claim 17 wherein the anticlotting agent is applied to the at least the portion of the analyte sensor by one or more of bath, spraying, brushing, or dipping.

21. An analyte detection system, comprising:

a sensing unit, the sensing unit consisting of an analyte sensor; and

a sensor control unit operatively coupled to and in signal communication with the sensing unit.

22. The system of claim 21 wherein the sensor control unit comprises a transmitter.

23. The system of claim 21 further including a receiver unit configured to receive data from the sensor control unit.

24. The system of claim 23 wherein the receiver unit is configured to receive calibration data.

25. A method, comprising the steps of:

detecting one or more analyte levels for a predetermined period, the detecting step consisting of establishing fluid contact between at least a portion of an analyte sensor and the analyte, and determining one or more signals corresponding to a respective one or more of the analyte levels for the predetermined period from the analyte sensor; and

processing the detected one or more analyte levels.

26. The method of claim 25 wherein the predetermined period includes one of a three day period, a five day period, or a seven day period.

27. A method, comprising:

detecting a first analyte level from a first analyte detecting device;

detecting a second analyte level from a second analyte detecting device;

comparing the first analyte level and the second analyte level; and

basing a health related decision based on the comparison.

28. The method of claim 27 wherein the first analyte detecting device and the second analyte detecting device are each one of a subcutaneous analyte sensor, an implantable analyte sensor, or a transdermal analyte sensor, or a test strip.

29. The method of claim 27 further including the steps of:

positioning the first analyte detecting device at a first location on a patient; and

positioning the second analyte detecting device at a second location on the patient.

30. The method of claim 27 wherein the step of detecting the first analyte level includes the step of positioning a first sensor at a first location on a patient, and further, wherein the step of detecting the second analyte level includes the step of positioning a second sensor at a second location on the patient.

31. The method of claim 27 wherein the step of basing the health related decision includes the steps of:

determining a drug administration protocol associated with the first analyte level, second analyte level or a combination of the first and the second analyte levels; and

generating a command based on the determining step.

32. The method of claim 27 wherein the step of providing the health related decision includes an alert to replace the first analyte detecting device, second analyte detecting device or both the first and second analyte detecting devices.

33. A system including analyte monitoring, comprising:

a first analyte detecting device for detecting a first analyte level;

a second analyte detecting device for detecting a second analyte level; and

a control unit operatively coupled to the first and second analyte detecting devices, the controller configured to receive one or more signals corresponding to the first and second analyte levels the control unit further configured to base a health related action based on the received one or more signals.

34. The system of claim 33 wherein the first analyte detecting device and the second analyte detecting device are each one of a subcutaneous analyte sensor, an implantable analyte sensor, a transdermal analyte sensor, or a test strip.

35. The system of claim 33 wherein the first analyte detecting device is positioned at a first location on a patient, and further, wherein the second analyte detecting device is positioned at a second location on the patient such that at least a portion of the first and second analyte detecting devices are in fluid contact with the analyte of the patient.