Analyte monitoring device and methods of use

• US 8,231,532 B2
• Filed: 04/30/2007
• Issued: 07/31/2012
• Est. Priority Date: 04/30/1998
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• 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:
  US11/742,453
• Publication Number:
  US 20070208247A1
• Time in Patent Office: 1,919 Days
• Field of Search: 600/309, 600345-366
• 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 glucose detection system, comprising:

a glucose sensor;

a data storage unit to store glucose data of the glucose sensor;

a processor configured to process the stored glucose data to predict a glucose-related trend; and

a display unit operatively coupled to the processor for displaying a graph indicating the predicted glucose related trend;

wherein the glucose related trend includes one of an acceleration of glucose level increase or decrease.

2. The system of claim 1, wherein the glucose-related trend includes one of a rate of glucose level increase or decrease.

3. The system of claim 1, wherein the acceleration of glucose level increase or decrease includes acceleration in the rate of change of the analyte level.

4. The system of claim 1, including a sensor control unit, wherein the sensor control unit includes the data storage unit.

5. The system of claim 4, wherein the data storage unit is a readable/writable memory device.

6. The system of claim 1 wherein the displayed glucose-related trend includes a composite indicator.

7. The system of claim 6 wherein one or more portions of the composite indicator is activated to indicate one or more conditions indicated by the glucose data from the glucose sensor.

8. The system of claim 7 wherein the one or more conditions indicated by the glucose data includes hyperglycemia, impending hyperglycemia, hypoglycemia, impending hypoglycemia, a malfunction, an error condition, or when a calibration sample is needed.

13. The device of claim 8 wherein the displayed glucose-related trend includes a composite indicator.

19. The device of claim 13 wherein one or more portions of the composite indicator is activated to indicate one or more conditions indicated by the glucose data from the glucose sensor.

20. The device of claim 19 wherein the one or more conditions indicated by the glucose data includes hyperglycemia, impending hyperglycemia, hypoglycemia, impending hypoglycemia, a malfunction, an error condition, or when a calibration sample is needed.

9. A glucose monitoring device, comprising:

an interface for receiving glucose data from a glucose sensor;

a data storage unit coupled to the interface for storing the glucose data;

a processor configured to process the stored glucose data to predict a glucose-related trend; and

a display unit operatively coupled to the processor to display a graph indicating the predicted glucose related trend;

wherein the glucose related trend includes one of an acceleration of the glucose level increase or decrease.

10. The device of claim 9, wherein the glucose-related trend includes one of a rate of glucose level increase or decrease.

11. The device of claim 9, wherein the acceleration of glucose level increase or decrease includes acceleration in the rate of change of the glucose level.

12. The device of claim 9, wherein the data storage unit is a readable/writable memory device.

14. The device of claim 9 including a communication unit operatively coupled to the processor, the communication unit configured to transmit one or more of the glucose data or the glucose-related trend.

15. The device of claim 14 wherein the communication unit includes a wireless communication unit.

16. The device of claim 14 wherein the communication unit includes an RF transmitter.

17. The device of claim 16 wherein the RF transmitter is configured to transmit the one or more of the glucose data or the glucose-related trend to a remote location.

18. The device of claim 14 wherein the communication unit includes an RF transceiver.

21. A method of processing glucose data, comprising:

positioning at least a portion of a glucose sensor in contact with bodily fluid of an individual;

obtaining glucose-related information using the sensor for processing using a processor operatively coupled to the sensor;

storing in a memory the sensor obtained information;

processing the stored data and predicting glucose-related trend using the processor; and

outputting on a display unit a graph indicating the predicted glucose related trend, the glucose related trend including one of an acceleration of the glucose level increase or decrease.

22. The method of claim 21 including displaying the glucose-related trend.

23. The method of claim 22 wherein displaying the glucose related trend includes displaying a composite indicator, wherein one or more portions of the composite indicator is activated to indicate one or more conditions indicated by the glucose data from the glucose sensor.

24. The method of claim 23 wherein the one or more conditions indicated by the glucose data includes hyperglycemia, impending hyperglycemia, hypoglycemia, impending hypoglycemia, a malfunction, an error condition, or when a calibration sample is needed.