Analyte monitoring device and methods of use

Patent metadata

Field	Value
Publication number	US-9498159-B2
Application number	US-92866807-A
Country	US
Kind code	B2
Filing date	Oct 30, 2007
Priority date	Jan 2, 2001
Publication date	Nov 22, 2016
Grant date	Nov 22, 2016

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.

First claim

What is claimed is:

1. An analyte monitoring system, comprising:
a transcutaneous analyte sensor including a conductive trace comprising a working electrode having an analyte responsive enzyme disposed on at least a portion of the working electrode, the analyte sensor positioned in fluid contact with a bodily fluid and adapted to monitor an analyte level in the bodily fluid during an entire sensor lifetime from when the sensor is initially positioned in fluid contact with the bodily fluid and continuously operating to generate signals representative of the analyte level of the bodily fluid until the analyte sensor is removed for replacement;
sensor electronics including an application specific integrated circuit electrically coupled to the conductive trace of the sensor, the application specific integrated circuit configured to process signals representative of the analyte level of the bodily fluid received from the sensor, the sensor electronics generating data representative of the monitored analyte level using a factory determined calibration data during the entire sensor lifetime of at least one week, wherein the application specific integrated circuit is configured to encrypt the generated data for transmission; and
a remote device that receives the encrypted data representative of the monitored analyte level generated by the sensor electronics, the remote device configured to evaluate whether the encrypted data are signals from a source other than the sensor electronics by at least decrypting the received encrypted data and comparing the decrypted data with a predetermined range of physiologically relevant values, and, in response to determining the encrypted data are from the sensor electronics, to display real time analyte level information and a rate of change information of analyte level based on the decrypted data.

2. The system of claim 1 , further including an antenna electrically coupled to the sensor electronics to transmit the encrypted generated data representative of the monitored analyte level.

3. The system of claim 2 , wherein the antenna communicates with the remote device when the remote device is positioned within a predetermined distance from the sensor electronics antenna.

4. The system of claim 3 , wherein the remote device includes a receiver to display information related to the monitored analyte level of the bodily fluid.

5. The system of claim 4 , wherein the displayed information includes a numerical information corresponding to the monitored analyte level.

6. The system of claim 1 , wherein the remote device determines the rate of change information of the monitored analyte level based on the encrypted data received from the sensor electronics.

7. The system of claim 1 , wherein the working electrode comprises the analyte responsive enzyme bonded to a polymer disposed on the working electrode.

8. The system of claim 7 , wherein the analyte response enzyme is chemically bonded to the polymer disposed on the working electrode.

9. The system of claim 7 , wherein the working electrode further comprises a mediator crosslinked with the polymer.

10. The system of claim 1 , wherein a threshold level associated with the monitored analyte level is configured by a user, the threshold level associated with a condition related to a processing of the signals representative of the analyte level for transmission, and further, wherein the sensor electronics is configured to reduce noise or errors in the signals representative of the analyte level.

11. The system of claim 1 , wherein the working electrode comprises a mediator bonded to a polymer disposed on the working electrode.

12. The system of claim 11 , wherein the mediator is chemically bonded to the polymer.

13. The system of claim 1 , further including a temperature sensor operatively coupled to the sensor electronics and generating temperature signals during the sensor operation, the sensor electronics configured to generate data representative of the monitored analyte level based on the temperature signals.

14. The system of claim 13 , wherein encrypted data generated by the application specific integrated circuit includes data generated based on the temperature signals.

15. An analyte monitoring method, comprising:
positioning a transcutaneous analyte sensor in continuous fluid contact with a bodily fluid during an entire sensor lifetime from when the analyte sensor is initially positioned in fluid contact with the bodily fluid and continuously operating to generate signals representative of the analyte level of the bodily fluid until the analyte sensor is removed for replacement, the analyte sensor including a conductive trace comprising a working electrode having an analyte responsive enzyme disposed on at least a portion of the working electrode;
generating data representative of the monitored analyte level with sensor electronics including an application specific integrated circuit, wherein the signals generated by the analyte sensor during the continuous operation are processed by the sensor electronics using a factory determined calibration data during the entire sensor lifetime of at least one week, and encrypted by the application specific integrated circuit;
wirelessly receiving the encrypted data from the sensor electronics;
evaluating whether the encrypted data are signals from a source other than the sensor electronics by at least decrypting, at a remote device, the encrypted data wirelessly received from the sensor electronics and comparing the decrypted data with a predetermined range of physiologically relevant values; and
in response to determining the encrypted data are from the sensor electronics, generating analyte level information at the remote device using the decrypted data to display real time analyte level information and a rate of change of analyte level based on the decrypted data.

16. The method of claim 15 , further including electrically coupling an antenna to the sensor electronics to transmit the encrypted data corresponding to the signal representative of the monitored analyte level of the bodily fluid.

17. The method of claim 16 , further including positioning the remote device within a predetermined distance from the sensor electronics antenna such that the antenna communicates with the remote device.

18. The method of claim 17 , wherein the remote device includes a receiver to display the real time analyte level information and the rate of change information of the analyte level.

19. The method of claim 18 , wherein the displayed information includes a numerical information corresponding to the monitored analyte level.

20. The method of claim 16 , wherein generating data representative of the analyte level includes reducing noise or errors in the signals representative of the analyte level by the application specific integrated circuit prior to transmitting the encrypted data.

21. The method of claim 14 , further including determining the rate of change information of the monitored analyte level based on the encrypted data received from the sensor electronics.

22. The method of claim 15 , wherein the working electrode comprises the analyte responsive enzyme bonded to a polymer disposed on the working electrode.

23. The method of claim 22 , wherein the analyte response enzyme is chemically bonded to the polymer disposed on the working electrode.

24. The method of claim 22 , wherein the working electrode further comprises a mediator cr

Assignees

• Heller Adam
• Drucker Steven H
• Jin Robert Y
• Funderburk Jeffery V
• Abbott Diabetes Care Inc

Inventors

• Heller Adam
• Drucker Steven H
• Jin Robert Y
• Funderburk Jeffery V

Classifications

• A61B5/1495 Primary

  Calibrating or testing of in-vivo probes · CPC title

• A61B5/14503

  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 title

• A61B5/743

  Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots · CPC title

• A61B2560/063

  Devices specially adapted for delivering implantable medical measuring apparatus · CPC title

• A61B5/0031

  Implanted circuitry · CPC title