Analyte sensor

• US 8,231,531 B2
• Filed: 06/01/2006
• Issued: 07/31/2012
• Est. Priority Date: 07/13/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark, Masterson, Steve, Dobbles, J. Michael, Mensinger, Michael Robert, Saint, Sean, Kamath, Apurv Ullas, Brauker, James, Thrower, James Patrick
• Primary Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US11/445,792
• Publication Number:
  US 20070038044A1
• Time in Patent Office: 2,252 Days
• Field of Search: 600/345, 600/347, 600/365
• US Class Current: 600/309
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2560/028 Arrangements to prevent overuse, e.g. by counting the number of uses
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14517 for sweat
• 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 5/1486 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 5/6832 using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61L 2/12 Microwaves
• CPC Class Codes: A61L 2/206 : Ethylene oxide
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
• CPC Class Codes: Y10T 29/49004 : including measuring or testing of device or component part

Abstract

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Claims

1. A sensor system configured to measure an analyte concentration in a host, the system comprising:

a sensor configured to be implanted in a host and configured to measure an analyte concentration in a tissue of the host; and

electronics operatively connectable to the sensor and configured to provide analyte data representative of the analyte concentration in the host, wherein the electronics are configured to identify an insertion of the sensor into the tissue of the host,

wherein the sensor system is configured to ensure that a user removes a used sensor and inserts a new sensor into the tissue of the host prior to display of sensor data associated with the new sensor.

2. The sensor system of claim 1, further comprising:

a housing adapted for placement external to the host'"'"'s tissue and for supporting the sensor while the sensor is implanted into the host; and

an electronics unit configured to be releasably attached to said housing during use of the sensor system, wherein the electronics are incorporated in the electronics unit.

3. The sensor system of claim 1, wherein the electronics reside in a handheld receiver and the sensor is operatively connected to the sensor via wireless communication.

4. The sensor system of claim 1, wherein the sensor system comprises a plurality of single use sensors configured to be implanted in a host and configured to measure an analyte concentration in a tissue of the host and a reusable electronics unit incorporating the electronics.

5. The sensor system of claim 1, wherein the electronics unit is configured to be operably connected to a first sensor during a first time period and be operably to a second sensor during a second time period that is different from the first time period and wherein the electronics are configured to identify insertion of the first sensor and identify insertion of the second sensor.

6. The sensor system of claim 1, wherein the sensor system is configured to confirm that the sensor has been inserted into the host'"'"'s tissue before initializing the sensor, such that reuse of a previously used sensor is prevented.

7. A sensor system configured to measure an analyte concentration in a host, the system comprising:

a sensor configured to be implanted in a host and configured to measure an analyte concentration in a tissue of the host; and

electronics operatively connectable to the sensor and configured to provide analyte data representative of the analyte concentration in the host, wherein the electronics are configured to identify an insertion of the sensor into the tissue of the host,

wherein the electronics are configured to identify an insertion of the sensor into the tissue of the host by algorithmically detecting a new sensor insertion.

8. The sensor system of claim 7, wherein the electronics are further configured to calibrate the sensor using reference data from a reference analyte monitor.

9. The sensor system of claim 7, further comprising:

a housing adapted for placement external to the host'"'"'s tissue and for supporting the sensor while the sensor is implanted into the host; and

an electronics unit configured to be releasably attached to said housing during use of the sensor system, wherein the electronics are incorporated in the electronics unit.

10. The sensor system of claim 7, wherein the sensor system comprises a plurality of single use sensors configured to be implanted in a host and configured to measure an analyte concentration in a tissue of the host and a reusable electronics unit incorporating the electronics.

11. The sensor system of claim 7, wherein the sensor system is configured to confirm that the sensor has been inserted into the host'"'"'s tissue prior to initializing the sensor.

12. The sensor system of claim 7, wherein the system is configured to prevent use of the sensor beyond a predetermined amount of sensor use.

13. The system of claim 7, wherein the sensor system is configured to prevent re-initialization of the sensor.

14. The sensor system of claim 7, wherein the sensor system is configured to identify the insertion of the sensor into the host'"'"'s tissue without manual input into the system indicating insertion of the sensor.

15. A sensor system configured to measure an analyte concentration in a host, the system comprising:

a sensor configured to be implanted in a host and configured to measure an analyte concentration in a tissue of the host, the sensor having an ex vivo portion that resides outside of a body of the host during use; and

electronics operatively connectable to the sensor and configured to provide analyte data representative of the analyte concentration in the host, wherein the electronics are configured to identify an insertion of an in vivo portion of the sensor into the tissue of the host;

wherein the sensor system is configured to discontinue display of the analyte data after a predetermined time period has passed since the identification of the sensor insertion.

16. The sensor system of claim 15, further comprising:

a housing adapted for placement external to the host'"'"'s tissue and for supporting the sensor while the sensor is implanted into the host; and

an electronics unit configured to be releasably attached to said housing during use of the sensor system, wherein the electronics are incorporated in the electronics unit.

17. The sensor system of claim 15, wherein the sensor system comprises a plurality of single use sensors configured to be implanted in a host and configured to measure an analyte concentration in a tissue of the host and a reusable electronics unit incorporating the electronics.

18. The sensor system of claim 15, wherein the sensor system is configured to identify the insertion of the sensor into the host'"'"'s tissue without manual input into the system indicating insertion of the sensor.

19. A sensor system configured to measure an analyte concentration in a host, the system comprising:

a sensor configured to be implanted in a host and configured to measure an analyte concentration in a tissue of the host; and

electronics operatively connectable to the sensor and configured to provide analyte data representative of the analyte concentration in the host, wherein the electronics are configured to identify an insertion of the sensor into the tissue of the host,

wherein the electronics are additionally configured to identify a removal of the sensor from the tissue of the host.

20. The sensor system of claim 19, further comprising:

a housing adapted for placement external to the host'"'"'s tissue and for supporting the sensor while the sensor is implanted into the host; and

an electronics unit configured to be releasably attached to said housing during use of the sensor system, wherein the electronics are incorporated in the electronics unit.

21. The sensor system of claim 19, wherein the sensor system comprises a plurality of single use sensors configured to be implanted in a host and configured to measure an analyte concentration in a tissue of the host and a reusable electronics unit incorporating the electronics.

22. The sensor system of claim 19, wherein the sensor system is configured to identify the insertion of the sensor without manual input into the system indicating insertion of the sensor and removal of the sensor without manual input into the system indicating removal of the sensor.

23. A sensor system configured to measure an analyte concentration in a host, the system comprising:

a sensor configured to be implanted in a host and configured to measure an analyte concentration in a tissue of the host; and

electronics operatively connectable to the sensor and configured to provide analyte data representative of the analyte concentration in the host, wherein the electronics are configured to identify an insertion of the sensor into the tissue of the host,

wherein the electronics are additionally configured to identify insertion of the sensor by detecting a change in a signal generated by the sensor, wherein the change satisfies one or more predetermined criteria, and

wherein the one or more predetermined criteria comprises a voltage change in the signal exceeding a predetermined threshold.

24. The sensor system of claim 23, further comprising:

a housing adapted for placement external to the host'"'"'s tissue and for supporting the sensor while the sensor is implanted into the host; and

an electronics unit configured to be releasably attached to said housing during use of the sensor system, wherein the electronics are incorporated in the electronics unit.

25. The sensor system of claim 23, wherein the sensor system comprises a plurality of single use sensors configured to be implanted in a host and configured to measure an analyte concentration in a tissue of the host and a reusable electronics unit incorporating the electronics.

26. The sensor system of claim 23, wherein the sensor system is configured to identify the insertion of the sensor without manual input into the system indicating insertion of the sensor.

27. A sensor system configured to measure an analyte concentration in a host, the system comprising:

a sensor configured to be implanted in a host and configured to measure an analyte concentration in a tissue of the host, the sensor having an ex vivo portion that resides outside of a body of the host during use;

electronics operatively connectable to the ex vivo portion of the sensor and configured to provide analyte data representative of the analyte concentration in the host, wherein the electronics are configured to identify an insertion of an in vivo portion of the sensor into the tissue of the host; and

a user interface operably connected to the electronics, wherein the electronics are configured to control the user interface responsive to the identification of the sensor insertion.

28. The sensor system of claim 27, further comprising:

a housing adapted for placement external to the host'"'"'s tissue and for supporting the sensor while the sensor is implanted into the host; and

an electronics unit configured to be releasably attached to said housing during use of the sensor system, wherein the electronics are incorporated in the electronics unit.

29. The sensor system of claim 27, wherein the sensor system comprises a plurality of single use sensors configured to be implanted in a host and configured to measure an analyte concentration in a tissue of the host and a reusable electronics unit incorporating the electronics.

30. The sensor system of claim 27, wherein identification of sensor insertion comprises identifying reuse of the sensor and wherein control of the user interface comprises disabling display of sensor data on the user interface responsive to identifying reuse of the sensor.

31. The sensor system of claim 27, wherein the sensor system is configured to identify the insertion of the sensor into the host'"'"'s tissue without manual input into the system indicating insertion of the sensor.

32. A sensor system configured to measure an analyte concentration in a host, the system comprising:

a sensor configured to be implanted in a host and configured to measure an analyte concentration in a tissue of the host; and

electronics operatively connectable to the sensor and configured to provide analyte data representative of the analyte concentration in the host, wherein the electronics are configured to identify an insertion of the sensor into the tissue of the host,

wherein the electronics are further configured to;

determine that a user removed a used sensor from the tissue of the host prior to the insertion of a new sensor;

generate the analyte data using the sensor; and

display information based on the analyte data,

wherein the sensor system displays the analyte data only after determining that the user removed the used sensor from the tissue of the host.

33. A sensor system configured to measure an analyte concentration in a host, the system comprising:

a sensor configured to be implanted in a host and configured to measure an analyte concentration in a tissue of the host, the sensor having an ex vivo portion that resides outside of a body of the host during use;

electronics operatively connectable to the ex vivo portion of the sensor and configured to provide analyte data representative of the analyte concentration in the host, wherein the electronics are configured to identify an insertion of an in vivo portion of the sensor into the tissue of the host;

a hardware key configured to connect to the electronics, wherein the hardware key comprises information selected from the group consisting of manufacturing information, calibration information, identification information, expiration information, duration information, insertion information, and combinations thereof; and

packaging configured to contain the sensor and the hardware key.