Analyte Monitoring Device and Methods of Use

• US 20070213610A1
• Filed: 03/02/2007
• Published: 09/13/2007
• 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: Friedman, Keith, Heller, Ephraim, Heller, Adam, Say, James, Gal, Yoram, Aria, Behrad, Tomasco, Michael, Vreeke, Mark, Colman, Fredric, Plante, Phillip
• Granted Patent: US 9,042,953 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• 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. A method for calibrating a continuous glucose monitoring system, comprising:

positioning at least a portion of an electrochemical sensor in the body of a user;

obtaining signal from the electrochemical sensor;

determining a rate of change of the obtained signal; and

determining whether calibration is appropriate based on the determined rate of change.

2. The method of claim 1 wherein determining whether calibration is appropriate includes comparing the determined rate of change to a predetermined value.

3. The method of claim 2 wherein the predetermined value is approximately 0.25 mg/dL per minute or less.

4. The method of claim 2 wherein when the determined rate of change is above the predetermined value, determining that calibration is not appropriate.

5. The method of claim 4 further including waiting a predetermined time period before performing calibration.

6. The method of claim 2 wherein the predetermined value is approximately 0.5 mg/dL per minute.

7. The method of claim 6 wherein when the determined rate of change is below the predetermined value, determining that calibration is appropriate.

8. The method of claim 1 further comprising performing calibration using a blood sample to calibrate the electrochemical sensor signal.

9. A method of glucose determination, comprising:

positioning at least a portion of an electrochemical sensor in the body of a user;

obtaining signal from the electrochemical sensor; and

performing a rate of change analysis based on the obtained signal.

10. The method of claim 9 wherein the rate of change analysis includes determining whether calibration is appropriate.

11. An analyte monitoring device, comprising:

an introducer for positioning at least a portion of an electrochemical sensor in the body of a user; and

a data processing unit configured to obtain signal from the electrochemical sensor, determine a rate of change of the obtained signal, and determine whether calibration is appropriate based on the determined rate of change.

12. The device of claim 11 wherein the data processing unit is further configured to compare the determined rate of change to a predetermined value to determine whether calibration is appropriate.

13. The device of claim 11 wherein the predetermined value is approximately 0.25 mg/dL per minute or less.

14. The device of claim 11 wherein when the determined rate of change is above the predetermined value, the data processing unit is further configured to determine that calibration is not appropriate.

15. The device of claim 11 wherein the predetermined value is approximately 0.5 mg/dL per minute.

16. The device of claim 15 wherein when the determined rate of change is below the predetermined value, the data processing unit is further configured to determine that calibration is appropriate.

17. The device of claim 11 wherein the data processing unit is further configured to perform calibration using a blood sample to calibrate the electrochemical sensor signal.

18. The device of claim 11 further including a transmitter operatively coupled to the data processing unit.

19. The device of claim 18 wherein the transmitter is configured to transmit one or more signals associated with the obtained signal, the rate of change, or the determination whether calibration is appropriate.

20. The device of claim 18 wherein the transmitter is configured to transmit one or more signals associated with the obtained signal.

21. The device of claim 18 wherein the transmitter is configured to wirelessly transmit one or more signals associated with the obtained signal to a receiver.

22. An analyte monitoring device, comprising:

a receiver configured to receive signal from an electrochemical sensor, the receiver further configured to determine a rate of change of the signal and to determine whether calibration is appropriate based on the determined rate of change.

23. The device of claim 22 further including a display operatively coupled to the receiver to display one or more data associated with the signal, the rate of change, or the determination whether calibration is appropriate.