Analyte sensor

Patent metadata

Field	Value
Publication number	US-9451908-B2
Application number	US-201213720227-A
Country	US
Kind code	B2
Filing date	Dec 19, 2012
Priority date	Oct 4, 2006
Publication date	Sep 27, 2016
Grant date	Sep 27, 2016

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.

First claim

What is claimed is:

1. A method for processing analyte sensor data, the method comprising:
exposing an analyte sensor of an analyte sensor system to a biological fluid, wherein the sensor system comprises the sensor and sensor electronics, wherein the sensor is configured to measure a signal associated with an analyte concentration of a host; and
providing a fail-safe module comprising a processor for executing computer program code stored in memory to cause the processor to:
perform a steady state analysis and a transient analysis of the signal;
evaluate a relationship between the steady state analysis and the transient analysis; and
detect a malfunction of the sensor system based on the relationship.

2. The method of claim 1 , further comprising generating a signal associated with glucose.

3. The method of claim 1 , wherein the detecting step further comprises detecting an electrical malfunction.

4. The method of claim 1 , wherein the detecting step further comprises detecting a fluidics malfunction.

5. The method of claim 1 , wherein the detecting step further comprises detecting a sensor malfunction.

6. The method of claim 1 , wherein the detecting step further comprises performing a waveform analysis of the signal.

7. The method of claim 1 , wherein the detecting step further comprises performing an equilibrium and/or kinetic analysis of the signal.

8. The method of claim 7 , wherein the performing step further comprises evaluating a relationship between the equilibrium analysis and the kinetic analysis.

9. The method of claim 1 , further comprises providing at least one of an alert, an alarm, or an instruction.

10. The method of claim 9 , further comprising evaluating the detected malfunction against a criterion.

11. The method of claim 1 , wherein the evaluating step further comprises evaluating baseline information.

12. The method of claim 1 , wherein the evaluating step further comprises evaluating sensitivity information.

13. The method of claim 1 , further comprising calibrating the sensor system with a calibration solution.

14. The method of claim 1 , further comprising applying a potential to the sensor to generate the signal.

15. The method of claim 14 , further comprising switching the potential from a first setting to a second setting.

16. The method of claim 15 , wherein the first setting is held long enough for equilibration.

17. The method of claim 16 , wherein the second setting is held long enough for equilibration.

18. The method of claim 15 , wherein the first setting is a configured to be a measurement potential and the second setting is configured for non-measurement.

19. The method of claim 15 , wherein the switching of the potential from a first setting to a second setting is performed to measure a concentration of a non-glucose analyte.

20. The method of claim 19 , wherein the non-glucose analyte is oxygen.

21. The method of claim 1 , wherein the analyte sensor is configured to measure glucose and a non-glucose analyte.

22. The method of claim 21 , wherein the non-glucose analyte is oxygen.

23. The method of claim 1 , further comprising automatically detecting a code from the analyte sensor upon coupling of the sensor to sensor electronics.

24. The method of claim 23 , wherein the code is a calibration code.

25. The method of claim 1 , further comprising receiving an input from the user related to mealtime information.

26. The method of claim 25 , further comprising alerting the user responsive to detection of hyperglycemic or hypoglycemic conditions.

27. The method of claim 26 , further comprising displaying glucose concentration data over a period of time.

28. The method of claim 1 , wherein the sensor is associated with a priori information.

29. The method of claim 28 , wherein the a prior information is associated with sensor sensitivity to glucose.

30. The method of claim 1 , wherein the biological fluid is blood.

31. The method of claim 6 , wherein the step of performing a waveform analysis of the signal is performed to determine fluidics malfunction related to transport of the biological fluid to the sensor, wherein the biological fluid is blood.

32. The method of claim 1 , wherein the sensor comprises a first electrode, a second electrode and an enzyme-containing film disposed between the first electrode and the second electrode, wherein the first electrode and the second electrode are separated by a distance from 115 microns to 135 microns.

33. The method of claim 32 , wherein the first electrode is a working electrode and the second electrode is a reference or counter electrode.

34. The method of claim 33 , wherein the enzyme-containing film comprises a cellulosic derivative.

35. The method of claim 1 , wherein the sensor is configured to maintain substantial linearity at glucose concentrations from 0 mg/dL to 400 mg/dL during sensor use.

36. The method of claim 1 , wherein the sensor is configured to maintain substantial linearity at glucose concentrations from 50 mg/dL to 550 mg/dL during sensor use.

37. The method of claim 1 , wherein the sensor is configured to maintain substantial linearity at glucose concentrations from 0 mg/dL to 400 mg/dL at an O 2 concentration of 0.4 mg/L.

38. The method of claim 1 , wherein the sensor system is configured to provide an accuracy level corresponding to having substantially all glucose concentration measurement values within ±15mg/dl or ±20% of YSI values.

39. The method of claim 1 , wherein the sensor is configured to receive a sample volume of biological fluid of less than 1 μl.

40. The method of claim 1 , wherein the sensor and sensor electronics are configured to generate analyte concentration data substantially without signal contribution due to interfering species.

41. The method of claim 40 , wherein the interfering species is acetaminophen.

42. The method of claim 40 , wherein the interfering species is at least one of ascorbic acid, uric acid, or bilirubin.

43. A method for processing glucose sensor data, the method comprising:
exposing a glucose sensor of a glucose sensor system to a blood sample, wherein the sensor system comprises the sensor and sensor electronics;
applying a potential to the sensor;
switching the potential from a first setting to a second setting;
measuring at least one signal from the sensor to obtain a glucose concentration value of a user;
providing a fail-safe module comprising a processor for executing computer program code stored in memory to cause the processor to:
perform a steady state analysis and a transient analysis of the at least one signal;
evaluate a relationship between the steady state analysis and the transient analysis; and
detect a malfunction of the sensor system based on the relationship;

displaying, on a user interface, glucose concentration data over a period of time;
receiving an input from the user related to mealtime information and displaying mealtime information on the user interface; and
alerting the user responsive to detection of hyperglycemic or hypoglycemic conditions.

44.

Assignees

• Dexcom Inc

Inventors

• Kamath Apurv Ullas
• Leach Jacob S
• Li Ying
• Rong Daiting
• Saint Sean
• Simpson Peter C
• Brister Mark

Classifications

• A61M5/16804

  Flow controllers · CPC title

• A61B5/14865

  invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors · CPC title

• A61M2230/201

  Glucose concentration · CPC title

• A61M25/007

  Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked · CPC title

• A61B5/6848

  Needles · CPC title