Analyte monitoring device and methods of use

• US 8,649,841 B2
• Filed: 04/03/2007
• Issued: 02/11/2014
• Est. Priority Date: 04/30/1998
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Say, James, Tomasco, Michael F., Heller, Adam, Gal, Yoram, Behrad, Aria, Heller, Ephraim, Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A., Colman, Fredric C.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US11/695,607
• Publication Number:
  US 20070179372A1
• Time in Patent Office: 2,506 Days
• Field of Search: 600/309, 600345-366, 204/403.01
• US Class Current: 600/347
• 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 sensor system, comprising:

a sensor comprising at least one electrode; and

sensor electronics configured to measure an analyte concentration, wherein the sensor electronics comprise a data sampling portion in data communication with the at least one electrode, wherein the data sampling portion comprises an analog portion configured to measure a current flowing at the at least one electrode and to convert a current measurement to one or more digital values representative of the current measurement, wherein the sensor electronics comprise an integrated circuit that is programmed to obtain a digital value from the data sampling portion and a data communication component that is configured to communicate data related to the analyte concentration at a predetermined time interval, and wherein the predetermined time interval is configured to be altered in response to one or more threshold levels associated with a low or high level of analyte or impending low or high level of analyte.

2. The sensor system of claim 1, wherein the predetermined time interval includes at least every minute.

3. The sensor system of claim 1, wherein the sensor electronics are configured to alter the predetermined time interval, wherein the predetermined time interval includes two transmissions per minute.

4. The system of claim 1, wherein the data sampling portion comprises a current-to-frequency converter.

5. The system of claim 1, further comprising a digital filter configured to smooth digital values from the data sampling portion.

6. The system of claim 1, wherein the communicated data related to the analyte concentration includes at least one digital value representative of the current.

7. The system of claim 6, wherein the at least one digital value comprises a filtered digital value.

8. The system of claim 6, wherein the communicated data related to the analyte concentration further includes sensor identification information.

9. The system of claim 3, wherein the predetermined time interval includes every 60 seconds.

10. The system of claim 1, wherein the sensor electronics are configured to measure the current flow in at least a picoAmp range.

11. The system of claim 1, wherein the communicated data related to the analyte concentration includes at least one digital value representative of the current and further includes sensor identification information.

12. The system of claim 11, wherein the sensor electronics are further configured to verify the sensor identification information encoded with the data.

13. The system of claim 1, wherein the sensor is configured to detect one or more glucose data points.

14. The system of claim 1, wherein the sensor is physically electrically contacted with the sensor electronics.

15. The system of claim 1, further comprising a receiver configured to determine glucose information corresponding to the communicated data related to the analyte concentration, and wherein the receiver is configured to output the glucose information.

16. The system of claim 1, further comprising a receiver operatively coupled to the sensor electronics configured to receive the communicated data related to the analyte concentration.

17. The system of claim 16, wherein the communicated data related to the analyte concentration is encoded, and wherein the receiver is configured to decode encoded signals received from the sensor electronics.

18. The system of claim 1, wherein the communicated data related to the analyte concentration further comprises at least one of a sensor ID code, status code and a calibration code.

19. The system of claim 1, wherein the at least one electrode comprises at least one working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, and at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and further wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

20. The system of claim 1, further including a temperature probe configured to obtain one or more temperature related signals.