Analyte Monitoring Device and Methods of Use

• US 20120108929A1
• Filed: 10/27/2011
• Published: 05/03/2012
• Est. Priority Date: 04/30/1998
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Peyser, Thomas, Heller, Adam
• Granted Patent: US 9,066,697 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• 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 5/0031 Implanted circuitry
• 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 5/1473 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 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units

Abstract

An analyte monitor including a sensor, a sensor control unit, and a display unit is disclosed. 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.

Claims

1. (canceled)

2. A device for continuous measurement of an analyte concentration, the device comprising:

a sensing mechanism configured to continuously measure a signal associated with an analyte concentration in a host; and

a membrane located over the sensing mechanism;

wherein the device is configured to provide, at analyte concentrations of from about 40 mg/dL to about 80 mg/dL, a level of accuracy of a mean absolute relative difference of no more than about 10% over a sensor session of at least about 3 days, wherein one or more reference measurements associated with calculation of the mean absolute relative difference are determined by analysis of blood; and

wherein the device is configured to provide, at analyte concentrations of from about 40 mg/dL to about 400 mg/dL, a level of accuracy of a mean absolute relative difference of no more than about 10% over the sensor session, wherein one or more reference measurements associated with calculation of the mean absolute relative difference are determined by analysis of blood.

3. The device of claim 2, wherein the membrane comprises an enzyme configured to react with the analyte.

4. The device of claim 2, wherein the membrane comprises a polyurethane and a hydrophilic portion.

5. The device of claim 2, wherein the membrane comprises a copolymer comprising a polycarbonate segment.

6. A device for continuous measurement of an analyte concentration, the device comprising:

a sensing mechanism configured to continuously measure a signal associated with an analyte concentration in a host; and

a membrane located over the sensing mechanism;

wherein, over a sensor session of at least about 3 days, the device is configured to;

provide a level of accuracy corresponding to a first mean absolute relative difference value at analyte concentrations of from about 40 mg/dL to about 80 mg/dL, wherein one or more reference measurements associated with calculation of the first mean absolute relative difference are determined by analysis of blood; and

provide a level of accuracy corresponding to a second mean absolute relative difference value at analyte concentrations of from about 40 mg/dL to about 400 mg/dL, wherein one or more reference measurements associated with calculation of the second mean absolute relative difference are determined by analysis of blood.

7. The device of claim 6 wherein the first mean absolute relative difference value is less than or about equal to the second mean absolute relative difference value.

8. The device of claim 6, wherein the membrane comprises an enzyme configured to react with the analyte.

9. The device of claim 6, wherein the membrane comprises a polyurethane and a hydrophilic portion.

10. The device of claim 6, wherein the membrane comprises a copolymer comprising a polycarbonate segment.

11. A system for continuous measurement of an analyte concentration, the system comprising:

a sensor comprising a sensing region configured to continuously produce sensor data associated with an analyte concentration in a host, wherein the sensor further comprises a membrane located over the sensing region;

a processor configured to process continuous sensor data; and

a user interface configured to display information associated with continuous sensor data;

wherein the sensor is configured to provide, at analyte concentrations of from about 40 mg/dL to about 80 mg/dL, a level of accuracy of a mean absolute relative difference of no more than about 10% over a sensor session of at least about 3 days, wherein one or more reference measurements associated with calculation of the mean absolute relative difference are determined by analysis of blood; and

wherein the sensor is configured to provide, at analyte concentrations of from about 40 mg/dL and about 400 mg/dL, a level of accuracy of a mean absolute relative difference of no more than about 10% over the sensor session, wherein one or more reference measurements associated with calculation of the mean absolute relative difference are determined by analysis of blood.

12. The system of claim 11, wherein the membrane comprises an enzyme configured to react with the analyte.

13. The system of claim 11, wherein the membrane comprises a polyurethane and a hydrophilic portion.

14. The system of claim 11, wherein the membrane comprises a copolymer comprising a polycarbonate segment.

15. A system for continuous measurement of an analyte concentration, the system comprising:

a sensor comprising a sensing mechanism configured to continuously measure a signal associated with an analyte concentration in a host, wherein the sensor further comprises a membrane located over the sensing mechanism;

a processor configured to process continuous sensor data; and

a user interface configured to display information associated with continuous sensor data;

wherein, over a sensor session of at least about 3 days, the system is configured to;

provide a level of accuracy corresponding to a first mean absolute relative difference value at analyte concentrations of from about 40 mg/dL to about 80 mg/dL, wherein one or more reference measurements associated with calculation of the first mean absolute relative difference are determined by analysis of blood; and

provide a level of accuracy corresponding to a second mean absolute relative difference value at analyte concentrations of from about 40 mg/dL to about 400 mg/dL, wherein one or more reference measurements associated with calculation of the second mean absolute relative difference are determined by analysis of blood.

16. The system of claim 15, wherein the first mean absolute relative difference value is less than or about equal to the second mean absolute relative difference value.

17. The system of claim 15, wherein the membrane comprises an enzyme configured to react with the analyte.

18. The system of claim 15, wherein the membrane comprises a polyurethane and a hydrophilic portion.

19. The system of claim 15, wherein the membrane comprises a copolymer comprising a polycarbonate segment.

20. A device for continuous measurement of an analyte concentration, the device comprising:

a sensing mechanism configured to continuously measure a signal associated with an analyte concentration in a host; and

a membrane located over the sensing mechanism, wherein the membrane comprises a polyurethane and a hydrophilic portion;

wherein the device is configured to provide, at analyte concentrations of from about 40 mg/dL to about 400 mg/dL, a level of accuracy corresponding to a mean absolute relative difference of no more than about 8% over a sensor session of at least about 3 days, wherein one or more reference measurements associated with calculation of the mean absolute relative difference are determined by analysis of blood.

21. The device of claim 20, wherein the sensor session is at least about 5 days.

22. The device of claim 20, wherein the sensor session is at least about 6 days.

23. The device of claim 20, wherein the sensor session is at least about 7 days.

24. The device of claim 20, wherein the sensor session is at least about 10 days.

25. The device of claim 20, wherein the mean absolute relative difference is no more than about 7% over the sensor session.

26. The device of claim 20, wherein the membrane comprises an enzyme configured to react with the analyte.

27. The device of claim 20, wherein the membrane comprises a polycarbonate segment.

28. A system for continuous measurement of an analyte concentration, the system comprising:

a sensor comprising;

a sensing region configured to continuously produce sensor data associated with an analyte concentration in a host; and

a membrane located over the sensing region, wherein the membrane comprises a polyurethane and a hydrophilic portion;

a processor configured to process continuous sensor data; and

a user interface configured to display information associated with continuous sensor data;

wherein the sensor is configured to provide, at analyte concentrations of from about 40 mg/dL to about 400 mg/dL, a level of accuracy corresponding to a mean absolute relative difference of no more than about 8% over a sensor session of at least about 3 days, wherein one or more reference measurements associated with calculation of the mean absolute relative difference are determined by analysis of blood.

29. The system of claim 28, wherein the sensor session is at least about 5 days.

30. The system of claim 28, wherein the sensor session is at least about 6 days.

31. The system of claim 28, wherein the sensor session is at least about 7 days.

32. The system of claim 28, wherein the sensor session is at least about 10 days.

33. The system of claim 28, wherein the mean absolute relative difference is no more than about 7% over the sensor session.

34. The system of claim 28, wherein the membrane comprises an enzyme configured to react with the analyte.

35. The system of claim 28, wherein the membrane comprises a polycarbonate segment.