Analyte monitoring device and methods of use

• US 20050199494A1
• Filed: 12/29/2004
• Published: 09/15/2005
• Est. Priority Date: 04/30/1998
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Heller, Ephraim, Heller, Adam, Say, James, Gal, Yoram, Colman, Fredric C., Aria, Behrad, Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A., Tomasco, Michael F.
• Granted Patent: US 9,011,331 B2
• Time in Patent Office: Days
• US Class Current: 204/403.01
• 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 glucose monitoring system, comprising:

a transmitter configured to transmit one or more detected glucose levels;

a processing circuit operatively coupled to the transmitter, the processing circuit configured to determine one or more trend information based on the one or more detected glucose levels; and

an output unit for outputting the one or more trend information.

2. The system of claim 1 wherein the output unit includes a display unit, and further, wherein the one or more trend information is displayed as a composite indicator.

3. The system of claim 2 wherein the composite indicator includes one or more of a directional arrow representative of the trend information, and one or more of color displays representative of the trend information.

4. The system of claim 2 wherein the composite indicator representative of the one or more trend information displayed on the display unit includes one or more of a two-dimensional graphical representation, a three-dimensional graphical representation, wherein each of the one or more of the two-dimensional graphical representation and the three-dimensional graphical representation includes historical and projected glucose levels associated with the detected glucose levels.

5. The system of claim 2 wherein the display unit includes one of an LCD display, and an LED display, and a plasma display.

6. The system of claim 1 wherein the one or more trend information includes one or more anticipated glucose related levels based on the one or more detected glucose levels.

7. The system of claim 6 wherein the one or more anticipated glucose related levels includes time information corresponding to an anticipated glucose level based on the detected glucose levels, exceeding a predetermined upper glucose level or falling below a predetermined lower glucose level.

8. The system of claim 1 wherein the one or more trend information includes one of an increase in a rate of acceleration and a decrease in a rate of deceleration of the glucose level based on the detected glucose levels.

9. The system of claim 1 wherein the one or more trend information includes one or more physiological conditions associated with the detected glucose levels.

10. The system of claim 9 wherein the one or more physiological conditions is a recurring condition.

11. The system of claim 1 further including a receiver unit operatively coupled to the transmitter for receiving the detected glucose levels, the receiver unit further configured to substantially house the output unit for outputting the trend information.

12. The system of claim 11 wherein the transmitter and the receiver are both configured to wirelessly communicate therewith to transmit data to and/or to receive data therefrom.

13. The system of claim 11 wherein the transmitter is configured to wirelessly transmit the detected glucose levels based on one of an RF communication protocol, a Bluetooth communication protocol, and an infrared communication protocol.

21. The system of claim 1 wherein the processing circuit is configured to determine the one or more trend information based on the detected glucose levels within a predetermined time period.

22. The system of claim 21 wherein the predetermined time period is less than about nine hours.

23. The system of claim of 21 wherein the predetermined time period includes about one of a one hour period, about a three hour period and or about a nine hour period.

24. The system of claim of 21 wherein the output unit is configured to output one or more of the one or more trend information and a current glucose level information.

14. A glucose monitoring system, comprising:

a transmitter configured to transmit one or more detected glucose levels;

a receiver unit operatively coupled to the transmitter for receiving the detected glucose levels, the receiver unit including a display unit; and

a processor operatively coupled to the transmitter and the receiver, the processor configured to determine one or more trend information based on the one or more detected glucose levels;

wherein the display unit is configured to output display the one or more trend information.

15. The system of claim 14 wherein the one or more trend information displayed on the display unit includes a graphical representation associated with the detected glucose levels, the graphical representation including one or more of a directional arrow representative of the trend information, and a color representation associated with the trend information.

16. The system of claim 14 wherein the processor includes an analyzer housed substantially in the receiver unit, the analyzer configured to predict one or more trends in the measured glucose levels.

17. The system of claim 14 wherein the processor includes a processing unit substantially integrated in the transmitter, the processing unit configured to evaluate one or more trends in the detected glucose level.

18. The system of claim 14 wherein the transmitter and the receiver unit are configured to communicate wirelessly with each other.

25. The system of claim 14 wherein the display unit is configured to display the one or more trend information based on the detected glucose levels within a predetermined time period.

26. The system of claim 25 wherein the predetermined time period includes one of about a one hour period, about a three hour period or about a nine hour period.

27. The system of claim 26 wherein the display unit is configured to display one or more of the one or more trend information and a current glucose level information.

19. A method of monitoring glucose, comprising the steps of:

detecting one or more glucose levels;

evaluating the detected one or more glucose levels to determine one or more trend information associated with the detected one or more glucose levels; and

outputting the one or more trend information.

20. The method of claim 19 wherein the one or more trend information output includes one or more of a graphical directional arrow indicator representative of the trend information, and a color coding scheme representative of the of the trend information.