ANALYTE MONITORING DEVICE AND METHODS OF USE

• US 20070249920A1
• Filed: 06/21/2007
• Published: 10/25/2007
• Est. Priority Date: 04/30/1998
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Friedman, Keith, Heller, Ephraim, Heller, Adam, Say, James, Aria, Behrad, Tomasco, Michael, Vreeke, Mark, Colman, Fredric, Plante, Phillip, Gal, Yoram
• Application Number:
  US11/766,726
• Publication Number:
  US 20070249920A1
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• 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 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• 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: C12Q 1/54 : involving glucose or galactose
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: H01L 23/3107 : the device being completely enclosed
• CPC Class Codes: H01L 23/49548 : Cross section geometry H01L23/49562 takes precedence
• CPC Class Codes: H01L 2924/00 : Indexing scheme for arrangements or methods for connecting or disconnecting semiconductor or solid-state bodies as covered by H01L24/00
• CPC Class Codes: H01L 2924/0002 : Not covered by any one of groups H01L24/00, H01L24/00 and H01L2224/00
• CPC Class Codes: H01L 2924/19041 : being a capacitor
• CPC Class Codes: H01L 2924/3011 : Impedance
• CPC Class Codes: Y10S 128/903 : Radio telemetry
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture
• CPC Class Codes: Y10T 29/49124 : On flat or curved insulated base, e.g., printed circuit, etc.

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 device, comprising:

a housing;

a communication unit coupled to the housing for receiving one or more analyte related signals monitored by an analyte sensor; and

a processor unit coupled to the communication unit to process the one or more analyte related signals, the processor unit configured to determine a calibration time period to calibrate the received one or more analyte related signals.

2. The device of claim 1, wherein the processor unit is configured to generate an output signal associated with the determined calibration time period.

3. The device of claim 1, wherein the calibration time period includes one or more of once every eight hours, once a day, and once a week.

4. The device of claim 1, wherein the processor unit determines the calibration time period according to the detection of a newly positioned analyte sensor.

5. The device of claim 1, wherein the processor unit determines the calibration time period according to the occurrence of at least one predefined parameter.

6. The device of claim 1, wherein the processor unit is configured to compare whether values from before and after the most recent calibration disagree by more than a threshold amount.

7. The device of claim 1, wherein the processor unit is configured not to allow calibration, or to reject a calibration point, based on an occurrence of at least one predetermined condition.

8. The device of claim 7, wherein the at least one predetermined condition includes detection of a temperature that is not within a predetermined range or detection of a temperature that is changing at a rate greater than a predetermined level.

9. The device of claim 8, wherein the predetermined range is approximately 30°

C. to approximately 42°

C.

10. The device of claim 8, wherein the predetermined level is approximately 0.2°

C./minute, approximately 0.5°

C./minute, or approximately 0.7°

C./minute.

11. The device of claim 7, wherein the at least one predetermined condition includes a plurality of contemporaneous uncalibrated signals that is not within a predefined range of each other.

12. The device of claim 11, wherein the predefined range includes an approximately 10% range or an approximately 20% range.

13. The device of claim 7, wherein the at least one predetermined condition includes a rate of change of the uncalibrated analyte sensor related signal above a predetermined threshold rate.

14. The device of claim 13, wherein the predetermined threshold rate is approximately 0.25 mg/dL per minute or approximately 0.5 mg/dL per minute or greater.

15. The device of claim 7, wherein the at least one predetermined condition includes detection of an uncalibrated analyte related signal greater than a maximum threshold value or less than a minimum threshold value.

16. The device of claim 15, wherein the maximum threshold value includes one of approximately 5 nA, approximately 10 nA, approximately 20 nA, or approximately 40 nA, and further, wherein the minimum threshold value includes one of approximately 0.05 nA, approximately 0.2 nA, approximately 0.5 nA, or approximately 1 nA.

17. The device of claim 7, wherein the at least one predetermined condition includes the calibrated analyte related signal that exceeds a maximum threshold level or that is below a predetermined minimum threshold level.

18. The device of claim 17, wherein the maximum threshold level includes an analyte concentration of approximately 200 mg/dL, approximately 250 mg/dL, or approximately 300 mg/dL, and further, wherein the minimum threshold level includes an analyte concentration of approximately 50 mg/dL, approximately 65 mg/dL, or approximately 80 mg/dL.

19. The device of claim 7, wherein the at least one predetermined condition includes a determination of less than a predetermined time period has elapsed since the transcutaneous positioning of the analyte sensor.

20. The device of claim 19, wherein the predetermined time period is approximately 30 minutes or less.

21. The device of claim 1 including a display unit coupled to the housing and the processor unit to display one or more signals associated with the determined calibration time period.

22. The device of claim 1, wherein the communication unit is configured to wirelessly receive the one or more analyte related signals.

23. The device of claim 1, wherein the communication unit includes an rf receiver.

24. A method, comprising:

receiving one or more analyte related signals monitored by an analyte sensor; and

processing the one or more analyte related signals to determine a calibration time period to calibrate the received one or more analyte related signals.

25. The method of claim 24 including generating an output signal associated with the determined calibration time period.

26. The method of claim 24, wherein the calibration time period includes one or more of once every eight hours, once a day, once a week.

27. The method of claim 24 including determining the calibration time period according to the detection of a newly positioned analyte sensor.

28. The method of claim 24 including determining the calibration time period according to the occurrence of at least one predefined parameter.

29. The method of claim 24 including comparing whether values from before and after the most recent calibration disagree by more than a threshold amount.

30. The method of claim 24 including not allowing calibration or rejecting a calibration point, based on an occurrence of at least one predetermined condition.

31. The method of claim 30, wherein the at least one predetermined condition includes detection of a temperature that is not within a predetermined range or detection of a temperature that is changing at a rate greater than a predetermined level.

32. The method of claim 30, wherein the at least one predetermined condition includes a plurality of contemporaneous uncalibrated signals that is not within a predefined range of each other.

33. The method of claim 30, wherein the at least one predetermined condition includes a rate of change of the uncalibrated analyte sensor related signal above a predetermined threshold rate.

34. The method of claim 30, wherein the at least one predetermined condition includes detection of an uncalibrated analyte related signal greater than a maximum threshold value or less than a minimum threshold value.

35. The method of claim 30, wherein the at least one predetermined condition includes the calibrated analyte related signal that exceeds a maximum threshold level or that is below a predetermined minimum threshold level.

36. The method of claim 30, wherein the at least one predetermined condition includes a determination of less than a predetermined time period has elapsed since the analyte sensor insertion.

37. The method of claim 24 including displaying one or more signals associated with the determined calibration time period.

38. The method of claim 24 including wirelessly receiving the one or more analyte related signals.