Analyte monitoring device and methods of use

• US 8,734,346 B2
• Filed: 04/30/2007
• Issued: 05/27/2014
• Est. Priority Date: 04/30/1998
• Status: Expired due to Term

• 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, Aria, Behrad, Heller, Ephraim, Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A., Colman, Fredric C.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US11/742,571
• Publication Number:
  US 20070203411A1
• Time in Patent Office: 2,584 Days
• Field of Search: 600345-366, 600/309
• 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 sensor system, comprising:

a sensor configured to measure an analyte concentration in interstitial fluid;

sensor electronics operably connected to the sensor, wherein the sensor electronics are configured to produce a signal associated with the analyte concentration in the interstitial fluid; and

a receiver configured to receive transmissions from the sensor electronics and to display sensor data related to the analyte concentration, wherein when the receiver has not been activated for a predetermined period of time, the receiver is configured to receive the transmissions from the sensor electronics but not to display the sensor data related to the analyte concentration.

2. The sensor system of claim 1, wherein the sensor electronics are programmed with an identification key comprising sensor information.

3. The sensor system of claim 2, wherein the sensor information comprises calibration information.

4. The sensor system of claim 2, wherein the sensor information comprises temperature information.

5. The sensor system of claim 2, wherein the sensor electronics are programmed to transmit the sensor information to the receiver.

6. The sensor system of claim 2, wherein the sensor data displayed by the receiver includes an output indicative of the sensor information.

7. The sensor system of claim 1, wherein the sensor electronics are programmed to store the sensor data.

8. The sensor system of claim 7, wherein the sensor electronics are programmed to transmit the stored sensor data and real time sensor data.

9. The sensor system of claim 8, wherein the sensor data displayed by the receiver includes the stored sensor data and the real time sensor data received from the sensor electronics.

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

11. The sensor system of claim 1, wherein the analyte concentration is a glucose concentration, a lactate concentration, or an oxygen concentration.

12. A method, comprising:

measuring an analyte concentration in interstitial fluid using a sensor;

producing a signal associated with the analyte concentration in the interstitial fluid using sensor electronics operably connected to the sensor;

receiving transmissions from the sensor electronics at a receiver; and

displaying sensor data related to the analyte concentration using the receiver;

wherein when the receiver has not been activated for a predetermined period of time, the receiver is configured to receive the transmissions from the sensor electronics but not to display the sensor data related to the analyte concentration.

13. The method of claim 12, wherein the sensor electronics are programmed with an identification key.

14. The method of claim 12, wherein the received transmissions from the sensor electronics includes calibration information.

15. The method of claim 12, wherein the received transmissions from the sensor electronics includes temperature information.

16. The method of claim 12, wherein the sensor data displayed using the receiver includes an output indicative of an analyte level.

17. The method of claim 12, further comprising storing the sensor data using the sensor electronics.

18. The method of claim 12, wherein the sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

19. The method of claim 12, wherein the analyte concentration is a glucose concentration, a lactate concentration, or an oxygen concentration.

20. The method of claim 12, wherein the received transmissions from the sensor electronics includes temperature information.