Analyte sensor

• US 20080119706A1
• Filed: 10/04/2006
• Published: 05/22/2008
• Est. Priority Date: 10/04/2006
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark, Simpson, Peter
• Granted Patent: US 8,532,730 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• 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 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

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 a host'"'"'s peripheral vein or artery.

Claims

1. A method for calibrating a continuous analyte sensor in a host, the method comprising:

inserting a continuous analyte sensor into a host;

contacting a calibration solution with at least a portion of the continuous analyte sensor; and

calibrating the continuous analyte sensor to provide calibrated analyte sensor data comprising at least one calibrated sensor data point.

2. The method of claim 1, wherein the continuous analyte sensor is configured to indwell within a blood stream of a host.

3. The method of claim 1, wherein the continuous analyte sensor is configured to measure a glucose concentration in the host.

4. The method of claim 3, wherein the calibration solution comprises a predetermined amount of glucose.

5. The method of claim 1, further comprising displaying the calibrated analyte sensor data.

6. The method of claim 1, further comprising contacting an additional calibration solution with at least a portion of the continuous analyte sensor.

7. The method of claim 6, further comprising calibrating or re-calibrating the continuous analyte sensor to provide calibrated analyte sensor data comprising at least one calibrated sensor data point.

8. The method of claim 6, wherein the step of contacting an additional calibration solution is repeated.

9. The method of claim 6, wherein the step of contacting an additional calibration solution is performed automatically.

10. The method of claim 6, wherein the step of contacting an additional calibration solution is performed manually.

11. The method of claim 1, further comprising contacting a non-analyte solution with at least a portion of the continuous analyte sensor to flush the sensor.

12. The method of claim 11, wherein the step of contacting a non-analyte solution is performed prior to the step of contacting a calibration solution with at least a portion of the continuous analyte sensor.

21. The method of claim 1, further comprising displaying the calibrated sensor data.

23. The method of claim 21, wherein the blood chemistry device performs the step of analyzing at least one blood sample from the host.

24. The method of claim 21, wherein the blood chemistry device performs the step of measuring a reference analyte value from the blood sample.

13. A method for calibrating a continuous analyte sensor in a host, the method comprising:

inserting a continuous analyte sensor system into a host;

withdrawing at least one blood sample from the host;

measuring a reference analyte value from the blood sample; and

calibrating the continuous analyte sensor to provide calibrated analyte sensor data comprising at least one calibrated sensor data point.

14. The method of claim 13, wherein the continuous analyte sensor is configured to indwell within a blood stream of the host.

15. The method of claim 13, wherein the continuous analyte sensor is configured to measure a glucose concentration of the host.

16. The method of claim 13, wherein the step of withdrawing at least one blood sample from the host is performed automatically.

17. The method of claim 13, wherein the step of inserting a continuous analyte sensor comprises inserting a vascular access device into communication with a vascular system of the host, wherein the sensor is integrally incorporated with the vascular access device.

18. The method of claim 17, wherein the step of withdrawing comprises withdrawing a blood sample through the vascular access device.

19. The method of claim 13, further comprising inserting a vascular access device into communication with a vascular system of the host, wherein the sensor is inserted through the vascular access device.

20. The method of claim 19, wherein the step of withdrawing comprises withdrawing a blood sample through the vascular access device.

22. The method of claim 13, further comprising coupling a blood chemistry device to the continuous analyte sensor system.

25. A continuous analyte sensor system, the system comprising:

a continuous analyte sensor configured for insertion into a host; and

a computer system operatively connected to the continuous analyte sensor, wherein the computer system is configured to receive analyte sensor data from the continuous analyte sensor, the analyte sensor data comprising at least one sensor data point and calibration information, and wherein the computer system is configured to calibrate the analyte sensor data from the calibration information.

26. The system of claim 25, wherein the analyte sensor is a glucose sensor.

27. The system of claim 25, wherein the continuous analyte sensor comprises a vascular access device configured for communication with a vascular system of the host, and wherein the continuous analyte sensor is configured to extend through the vascular access device, wherein the analyte sensor is configured to measure a concentration of an analyte within a vascular system of the host.

28. The system of claim 27, wherein the vascular access device is configured to operatively couple to a blood chemistry analysis device for measuring a blood chemistry of the host.

29. The system of claim 28, wherein the blood chemistry device is configured to withdraw a blood sample through the vascular access device, and wherein the calibration information comprises the blood sample or a measurement associated therewith.

30. The system of claim 28, wherein the blood chemistry device is configured to measure a reference analyte value from the host, and wherein the calibration information comprises the reference analyte value.

31. The system of claim 27, further comprising a device configured to automatically obtain the calibration information, wherein the device is operatively coupled to the sensor system.

32. The system of claim 25, wherein the continuous analyte sensor comprises a vascular access device configured for communication with a vascular system of the host, wherein the vascular access device comprises an analyte sensor at least partially integrally incorporated on an exterior surface the vascular access device and further comprises sensor electronics operatively connected to the analyte sensor, wherein the sensor electronics are configured to measure a concentration of an analyte within a blood stream of the host.

33. The system of claim 32, wherein the vascular access device is configured to operatively couple to a blood chemistry analysis device for measuring a blood chemistry of the host.

34. The system of claim 33, wherein the blood chemistry device is configured to withdraw a blood sample through the vascular access device, and wherein the calibration information comprises the blood sample or a measurement associated therewith.

35. The system of claim 33, wherein the blood chemistry device is configured to measure a reference analyte value from the host, and wherein the calibration information comprises the reference analyte value.

36. The system of claim 32, further comprising a device configured to automatically obtain the calibration information, wherein the device is operatively coupled to the sensor system.

37. The system of claim 25, wherein the analyte sensor comprises a working electrode and a reference electrode, and wherein at least one of the working electrode and the reference electrode comprises a wire.

38. The system of claim 25, wherein the analyte sensor comprises a working electrode and a reference electrode, wherein the working electrode and the reference electrode are both wires, and wherein the wires are coaxial.

39. The system of claim 25, wherein the analyte sensor comprises a working electrode and a reference electrode, wherein the working electrode and the reference electrode are both wires, and wherein the wires are juxtapositioned.

40. The system of claim 25, wherein the analyte sensor comprises a working electrode and a reference electrode, wherein the working electrode and the reference electrode are both wires, and wherein the reference electrode is helically wound around the working electrode.

41. The system of claim 25, wherein the analyte sensor comprises a working electrode, and wherein the working electrode is flexible.

42. The system of claim 25, wherein the analyte sensor comprises a working electrode, and wherein the working electrode has a variable stiffness.

43. The system of claim 25, wherein the analyte sensor comprises at least one wire having a helical configuration, and wherein a variable stiffness in the helical wire is provided by at least one of a variable pitch of the helical wire and a variable cross-section of the helical wire.