IP Library Granted Patent US 8,447,376
Granted Patent B2
US 8,447,376 · App. 12/267,531 · Granted May 21, 2013

Analyte sensor

Inventors: Mohammad Ali Shariati (Del Mar, CA); Ying Li (San Diego, CA); Apurv Ullas Kamath (San Diego, CA); Peter C. Simpson (Encinitas, CA); Richard C. Yang (Carlsbad, CA); Mark Brister (Encinitas, CA)
Assignee: Dexcom, Inc.
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Quick Facts
Patent No.
US 8,447,376
App. No.
12/267,531
Granted
May 21, 2013
Kind
B2
Abstract

Systems and methods of use for continuous analyte measurement of a host's vascular system are provided. In some embodiments, a continuous glucose measurement system includes a vascular access device, a sensor and sensor electronics, the system being configured for insertion into communication with a host's circulatory system.

Claims (58)

1. A system for performing a diagnostic of an analyte sensor system, comprising:

an analyte sensor system comprising a sensor, wherein the analyte sensor comprises a first working electrode configured to provide a first signal comprising an analyte component and a baseline component and a second working electrode configured to provide a second signal comprising a baseline component substantially without an analyte component;

a flow control device configured to intermittently expose the analyte sensor to a biological sample and an infusion solution; and

a processor module configured to evaluate the analyte sensor system based at least in part on the second signal, wherein the second signal comprises a signal waveform, and wherein the processor module is configured to evaluate the signal waveform for at least one of an expected shape or a pattern when the analyte sensor is exposed to at least one of the biological sample or the infusion solution.

2. The system of claim 1 , wherein the processor module is configured to evaluate the signal waveform by evaluating at least one of a similarity or a correlation between the signal waveform and a waveform template.

3. The system of claim 2 , wherein the waveform template is based at least in part on a priori information.

4. The system of claim 2 , wherein the waveform template is based at least in part on a signal waveform measured by the analyte sensor system.

5. The system of claim 2 , wherein the processor module is configured to evaluate at least one of a similarity or a correlation between the signal waveform and the waveform template by performing a correlation waveform analysis.

6. The system of claim 2 , wherein the processor module is further configured to update the waveform template when at least one of a similarity or a correlation between the signal waveform and the waveform template meets one or more criteria.

7. The system of claim 6 , wherein the processor module is configured to detect a level of an interferent in the biological sample, and wherein the processor module is further configured to update the waveform template when the level of the interferent meets one or more criteria.

8. The system of claim 1 , wherein the processor module is configured to evaluate the signal waveform by evaluating a monotonicity of the signal waveform.

9. The system of claim 8 , wherein the processor module is configured to evaluate a monotonicity at least in part by performing a correlation waveform analysis of the signal waveform with a waveform template.

10. The system of claim 8 , wherein the processor module is configured evaluate a monotonicity at least in part by performing a time-series analysis.

11. The system of claim 1 , wherein the processor module is configured to detect an interferent at least in part by evaluating at least one of an amplitude, a change in amplitude, a signal waveform, or a change in a signal waveform of the second signal when the sensor is exposed to a biological sample.

12. The system of claim 11 , wherein the processor module is configured to detect an interferent at least in part by evaluating a calibrated analyte value with one or more criteria.

13. The system of claim 12 , wherein the one or more criteria is based on physiological feasibility.

14. The system of claim 11 , wherein the processor module is configured to control a display of the analyte sensor system based at least in part on a level of an interferent detected on the second signal.

15. The system of claim 11 , wherein the processor module is further configured to process the first signal and the second signal to obtain a subtracted signal based at least in part on a level of an interferent of the sensor system.

16. The system of claim 1 , wherein the processor module is configured evaluate a level of reliability of the sensor system at least in part by comparing at least one of an amplitude, a change in amplitude, a signal waveform, or a change in a signal waveform of the second signal to one or more criteria.

17. The system of claim 16 , wherein the processor module is configured to control a display of the sensor system based at least in part on a level of reliability of the sensor system.

18. A system for performing a diagnostic of an analyte sensor system, comprising:

an analyte sensor system comprising a sensor, wherein the analyte sensor comprises a first working electrode configured to provide a first signal comprising an analyte component and a baseline component and a second working electrode configured to provide a second signal comprising a baseline component substantially without an analyte component;

a flow control device configured to intermittently expose the analyte sensor to a biological sample and an infusion solution; and

a processor module configured to evaluate the anal sensor system based at least in part on the second signal, wherein the processor module is further configured determine a success of drawing-back of a biological sample from a host's circulatory system to the analyte sensor, based at least in part on the evaluation of the analyte sensor system.

19. The system of claim 18 , wherein the processor module is configured to display an analyte value measured during the biological sample draw-back, in response to a determination of a successful draw-back of the biological sample.

20. The system of claim 18 , wherein the processor module is configured to evaluate a signal waveform by evaluating at least one of a similarity or a correlation between the signal waveform and a waveform template.

21. The system of claim 20 , wherein the waveform template is based at least in part on a priori information.

22. The system of claim 20 , wherein the waveform template is based at least in part on a signal waveform measured by the analyte sensor system.

23. The system of claim 20 , wherein the processor module is configured to evaluate at least one of a similarity or a correlation between the signal waveform and the waveform template by performing a correlation waveform analysis.

24. The system of claim 20 , wherein the processor module is further configured to update the waveform template when at least one of a similarity or a correlation between the signal waveform and the waveform template meets one or more criteria.

25. The system of claim 24 , wherein the processor module is configured to detect a level of an interferent in the biological sample, and wherein the processor module is further configured to update the waveform template when the level of the interferent meets one or more criteria.

26. The system of claim 18 , wherein the processor module is configured to evaluate a signal waveform by evaluating a monotonicity of the signal waveform.

27. The system of claim 26 , wherein the processor module is configured to evaluate a monotonicity at least in part by performing a correlation waveform analysis of the signal waveform with a waveform template.

28. The system of claim 26 , wherein the processor module is configured evaluate a monotonicity at least in part by performing a time-series analysis.

29. The system of claim 18 , wherein the processor module is configured to detect an interferent at least in part by evaluating at least one of an amplitude, a change in amplitude, a signal waveform, or a change in a signal waveform of the second signal when the sensor is exposed to a biological sample.

30. The system of claim 18 , wherein the processor module is configured evaluate a level of reliability of the sensor system at least in part by comparing at least one of an amplitude, a change in amplitude, a signal waveform, or a change in a signal waveform of the second signal to one or more criteria.

31. The system of claim 30 , wherein the processor module is configured to control a display of the sensor system based at least in part on a level of reliability of the sensor system.

32. The system of claim 18 , wherein the processor module is further configured to determine a success of infusing the infusion solution such that the biological sample is washed from the sensor.

33. The system of claim 32 , wherein the processor module is configured to display an analyte value measured in the biological sample after infusing the infusion solution, in response to a determination of a successful infusion.

34. A system for performing a diagnostic of ananalyte sensor system, comprising:

an analyte sensor system comprising a sensor, wherein the analyte sensor comprises a first working electrode configured to provide a first signal comprising an analyte component and a baseline component and a second working electrode configured to provide a second signal comprising a baseline component substantially without an analyte component;

a flow control device configured to intermittently expose the analyte sensor to a biological sample and an infusion solution; and

a processor module configured to evaluate the analyte sensor system based at least in part on the second signal, wherein the processor module is further configured to determine a success of infusing the infusion solution such that the biological sample is washed from the sensor.

35. The system of claim 34 , wherein the processor module is configured to display an analyte value measured in the biological sample after infusing the infusion solution, in response to a determination of a successful infusion.

36. The system of claim 34 , wherein the processor module is configured to evaluate a signal waveform by evaluating at least one of a similarity or a correlation between the signal waveform and a waveform template.

37. The system of claim 36 , wherein the waveform template is based at least in part on a priori information.

38. The system of claim 36 , wherein the waveform template is based at least in part on a signal waveform measured by the analyte sensor system.

39. The system of claim 36 , wherein the processor module is configured to evaluate at least one of a similarity or a correlation between the signal waveform and the waveform template by performing a correlation waveform analysis.

40. The system of claim 36 , wherein the processor module is further configured to update the waveform template when at least one of a similarity or a correlation between the signal waveform and the waveform template meets one or more criteria.

41. The system of claim 40 , wherein the processor module is configured to detect a level of an interferent in the biological sample, and wherein the processor module is further configured to update the waveform template when the level of the interferent meets one or more criteria.

42. The system of claim 34 , wherein the processor module is configured to evaluate a signal waveform by evaluating a monotonicity of the signal waveform.

43. The system of claim 42 , wherein the processor module is configured to evaluate a monotonicity at least in part by performing a correlation waveform analysis of the signal waveform with a waveform template.

44. The system of claim 42 , wherein the processor module is configured evaluate a monotonicity at least in part by performing a time-series analysis.

45. The system of claim 34 , wherein the processor module is configured to detect an interferent at least in part by evaluating at least one of an amplitude, a change in amplitude, a signal waveform, or a change in a signal waveform of the second signal when the sensor is exposed to a biological sample.

46. The system of claim 34 , wherein the processor module is configured evaluate a level of reliability of the sensor system at least in part by comparing at least one of an amplitude, a change in amplitude, a signal waveform, or a change in a signal waveform of the second signal to one or more criteria.

47. The system of claim 46 , wherein the processor module is configured to control a display of the sensor system based at least in part on a level of reliability of the sensor system.

48. The system of claim 34 , wherein the processor module is further configured determine a success of drawing-back of a biological sample from a host's circulatory system to the analyte sensor, based at least in part on the evaluation of the analyte sensor system.

49. The system of claim 48 , wherein the processor module is configured to display an analyte value measured during the biological sample draw-back, in response to a determination of a successful draw-back of the biological sample.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 4, 2012
From: BRISTER, MARK
To: DEXCOM, INC.
Reel/Frame 028895/0095 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 10, 2009
From: SHARIATI, MOHAMMAD ALI; LI, YING; KAMATH, APURV ULLAS; SIMPSON, PETER C.; YANG, RICHARD C.
To: DEXCOM, INC.
Reel/Frame 022233/0345 →
Continuity (23)
Continuation In Part 12055114 · Mar 25, 2008
Continuation In Part 12055203 · Mar 25, 2008
Continuation In Part 11691466 · Mar 26, 2007
Continuation In Part 11691424 · Mar 26, 2007
Continuation In Part 11691432 · Mar 26, 2007
Continuation In Part 11691426 · Mar 26, 2007
Continuation In Part 11691466 · Mar 26, 2007
Continuation In Part 11691424 · Mar 26, 2007
Continuation In Part 11691432 · Mar 26, 2007
Continuation In Part 11691426 · Mar 26, 2007
Continuation In Part 11543396 · Oct 4, 2006
Continuation In Part 11543490 · Oct 4, 2006
Continuation In Part 11543404 · Oct 4, 2006
Continuation In Part 11543396
Continuation In Part 11543490
Continuation In Part 11543404
Continuation In Part 11543396
Continuation In Part 11543490
Continuation In Part 11543404
Continuation In Part 11543396
Continuation In Part 11543490
Continuation In Part 11543404
Related Publication 20090137886A1 · May 28, 2009