Analyte Monitoring Device and Methods of Use

• US 20070161880A1
• Filed: 03/24/2007
• Published: 07/12/2007
• 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 8,774,887 B2
• 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 receiver unit for receiving one or more signals related to an analyte level detected by an electrochemical sensor, the receiver unit including a display to display an indication of the analyte level.

2. The device of claim 1 wherein the receiver unit includes an rf receiver.

3. The device of claim 2 wherein the receiver unit includes an analyzer coupled to the display and the rf receiver to analyze data from the rf receiver and provide analyzed data to the display.

4. The device of claim 2 wherein the rf receiver is configured to receive one or more analyte sensor data or calibration data.

5. The device of claim 1 wherein the receiver unit includes a calibrator.

6. The device of claim 5 wherein the calibrator is a blood glucose calibrator.

7. The device of claim 5 wherein the calibrator provides a calibration value using less that about one microliter of body fluid.

8. The device of claim 7 wherein the body fluid includes blood.

9. The device of claim 1 wherein the receiver unit includes an alarm configured to indicate when the analyte level is at or near a threshold level.

10. The device of claim 9 wherein the threshold level includes one of hypoglycemia, impending hypoglycemia, hyperglycemia, or impending hyperglycemia.

11. The device of claim 9 wherein the alarm includes one or more of an audible signal, a visual display, or a vibratory signal.

12. The device of claim 9 wherein the alarm is configured to automatically deactivate after a predetermined time period.

13. The device of claim 1 wherein the receiver unit is a portable handheld unit.

14. The device of claim 13 wherein the receiver unit is configured for wearing on or under an article of clothing.

15. The device of claim 1 wherein the receiver unit includes an rf transceiver configured to receive or transmit the one or more signals related to an analyte level.

16. The device of claim 1 wherein the analyte includes glucose.

17. The device of claim 1 wherein the receiver unit is further configured to communicate with a drug administration system.

18. The device of claim 17 wherein the receiver unit is configured to wirelessly communicate with the drug administration system.

19. The device of claim 18 wherein the receiver unit is configured to communicate with the drug administration system by rf communication.

20. The device of claim 1 wherein the receiver unit is configured to display one or more indicators associated with the analyte level on the display.

21. The device of claim 20 wherein the one or more indicators includes one or more of an arrow or a color representative of analyte level trend information.

22. The device of claim 20 wherein the displayed one or more indicators include a historical analyte level or a projected analyte level of a patient detected by the electrochemical sensor.

23. The device of claim 20 wherein the displayed one or more indicators corresponds to a rate of change in the analyte level detected by the electrochemical sensor.

24. A monitoring device, comprising:

a portable housing;

an rf receiver coupled to the portable housing, the rf receiver configured to wirelessly receive one or more signals related to an analyte level of a patient detected by an electrochemical sensor;

a processing unit coupled to the portable housing and to the rf receiver, the processing unit configured to process the one or more signal received by the rf receiver; and

a display unit coupled to the portable housing and the processing unit, the display unit configured to display an indication associated with the one or more signals related to the analyte level of the patient.

25. An analyte monitoring device, comprising:

a receiver unit for receiving one or more signals related to an analyte level detected by an electrochemical sensor, the receiver unit including a display to display an indication of the analyte level, and the receiver unit further configured to process one or more signals related to analyte related therapy for communication with a drug administration system.

26. The device of claim 25 wherein the receiver unit is configured for wireless communication of the one or more signals related to analyte related therapy.

27. The device of claim 25 wherein the receiver unit is configured for rf communication.

28. The device of claim 25 wherein the one or more signals related to analyte related therapy includes one or more signals related to an amount of drug for delivery by the drug administration system.

29. The device of claim 25 wherein the receiver unit is configured to receive one or more signals from the drug administration system.

30. The device of claim 29 wherein the one or more signals received from the drug administration system includes one or more signals related to drug sensitivity.