Analyte monitoring system and methods

• US 9,649,057 B2
• Filed: 05/11/2015
• Issued: 05/16/2017
• Est. Priority Date: 05/08/2007
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Fennell, Martin J., Sloan, Mark Kent, He, Lei
• Primary Examiner(s): Yacob, Sisay
• Application Number:
  US14/709,392
• Publication Number:
  US 20150238130A1
• Time in Patent Office: 736 Days
• Field of Search: 3405391, 34053922, 34053923, 3405731, 340500, 340540, 3406939, 600309, 600310, 600316, 600345, 600347
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• 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 5/0026 characterised by the transmission medium
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/14532 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 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• 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 5/742 using visual displays A61B5/339 takes precedence

Abstract

Methods and systems for providing data communication in medical systems are disclosed.

Claims

1. An analyte monitoring device, comprising:

an in vivo glucose sensor positioned in fluid contact with bodily fluid under a skin surface to generate signals corresponding to a glucose level in the bodily fluid; and

sensor electronics operatively coupled to the glucose sensor and configured to generate glucose data from the signals generated by the in vivo glucose sensor, the sensor electronics further configured to pair with a remote location using an encryption key, the encryption key being based on information associated with the sensor electronics, to establish a communication link between the sensor electronics and the remote location, wherein when the communication link is established and the sensor electronics is paired with the remote location, the sensor electronics is configured to transmit glucose data at a predetermined time interval and receives acknowledgement from the remote location when the glucose data is received at the remote location at the predetermined time interval, wherein the sensor electronics is further configured to receive the encryption key from the remote location, and the encryption key is generated at the remote location based on a received identification information of the sensor electronics.

2. The device of claim 1, wherein the sensor electronics is further configured to communicate the identification information to the remote location, wherein the identification information includes one or more of sensor electronics identifier information and glucose sensor parameter information.

3. The device of claim 2, wherein the glucose sensor parameter information includes a sensor calibration parameter stored in a memory device of the sensor electronics.

4. The device of claim 3, wherein the sensor calibration parameter includes a predetermined calibration code.

5. The device of claim 1, wherein the sensor electronics includes an application specific integrated circuit (ASIC).

6. The device of claim 1, wherein the sensor electronics is in wireless communication with the remote location.

7. The device of claim 1, wherein the sensor electronics includes a current to frequency conversion unit operatively coupled to the glucose sensor, the current to frequency conversion unit configured to receive current signals from the glucose sensor corresponding to the monitored glucose level, and to convert the received current signals to respective counts.

8. The device of claim 3, wherein the data transmitted to the remote location includes real time and historical data associated with the monitored glucose level, and further wherein the historical data associated with the monitored glucose level corresponds to signals obtained from the glucose sensor and stored in the memory prior to a time at which the sensor electronics transmit the glucose data.

9. The device of claim 1, wherein the glucose sensor includes a plurality of electrodes including a working electrode comprising a glucose-responsive enzyme bonded to a polymer disposed on the working electrode.

10. The device of claim 9, wherein the glucose-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

11. The device of claim 9, wherein the working electrode further includes a mediator.

12. The device of claim 11, wherein the mediator is crosslinked with the polymer.

13. The device of claim 1, wherein the glucose sensor includes a plurality of electrodes including a working electrode comprising a mediator bonded to a polymer disposed on the working electrode.

14. The device of claim 1, wherein the glucose sensor requires no user calibration when in fluid contact with the bodily fluid under the skin surface.

15. The device of claim 14, wherein the glucose sensor requires no user calibration during the time the glucose sensor monitors the glucose level in the bodily fluid.

16. The device of claim 1, wherein the glucose sensor is factory calibrated.

17. The device of claim 1, wherein the sensor electronics include a memory is configured to update a memory location in the memory by incrementing a bit count in the memory location, the incremented bit count corresponds to a remaining battery life of a battery in the sensor electronics.

18. The device of claim 1, wherein the sensor electronics receives the acknowledgement from the remote location at each predetermined time interval when the glucose data is received at the remote location.