Analyte sensor

• US 8,532,730 B2
• Filed: 10/04/2006
• Issued: 09/10/2013
• Est. Priority Date: 10/04/2006
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark, Simpson, Peter
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US11/543,404
• Publication Number:
  US 20080119706A1
• Time in Patent Office: 2,533 Days
• Field of Search: 600/347, 600/365
• US Class Current: 600/345
• 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 continuous analyte sensor system, the continuous analyte sensor system comprising:

a fluid coupler configured to operably connect with an IV equipment and with a vascular access device configured for communication with a vascular system of a host;

a continuous analyte sensor located in at least one of a lumen of the fluid coupler or a lumen of the vascular access device, wherein the continuous analyte sensor is configured to measure a concentration of an analyte within the vascular system of the 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, wherein the computer system is configured to process sensor data from the continuous analyte sensor by using information obtained prior to implantation, and wherein the computer system is configured to detect a change in sensitivity without requiring a reference analyte measurement;

wherein the continuous analyte sensor system is configured to measure analyte concentration without requiring a reference analyte measurement for calibration performed after implantation of the continuous analyte sensor.

2. The continuous analyte sensor system of claim 1, wherein the analyte sensor is a glucose sensor.

3. The continuous analyte sensor system of claim 1, wherein the continuous analyte sensor is configured to at least partially reside within the vascular access device.

4. The continuous analyte sensor system of claim 1, wherein the vascular access device comprises the analyte sensor, the analyte sensor at least partially integrally incorporated on an interior surface of the vascular access device.

5. The continuous analyte sensor system of claim 1, wherein the computer system is further configured to automatically obtain the calibration information.

6. The continuous analyte sensor system of claim 1, 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.

7. The continuous analyte sensor system of claim 1, 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.

8. The continuous analyte sensor system of claim 1, 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.

9. The continuous analyte sensor system of claim 1, wherein the analyte sensor comprises a working electrode, and wherein the working electrode is flexible.

10. The continuous analyte sensor system of claim 1, wherein the continuous analyte sensor comprises a first working electrode and an additional working electrode.

11. The continuous analyte sensor system of claim 10, wherein the first working electrode is configured to measure analyte and non-analyte related signals, and wherein the additional working electrode is configured to measure a non-analyte related signal.

12. The continuous analyte sensor system of claim 1, wherein at least a portion of the continuous analyte sensor is configured to float freely within the vascular access device.

13. The continuous analyte sensor system of claim 1, wherein the vascular access device comprises an anticoagulant coating.

14. The continuous analyte sensor system of claim 13, wherein the anticoagulant coating comprises heparin.

15. The continuous analyte sensor system of claim 1, wherein the continuous analyte sensor comprises an anticoagulant coating.

16. The continuous analyte sensor system of claim 15, wherein the anticoagulant coating comprises heparin.

17. The continuous analyte sensor system of claim 1, further comprising a fluid coupler configured to mate with the vascular access device.

18. The continuous analyte sensor system of claim 1, wherein the continuous analyte sensor system is operably coupled to an additional medical device.

19. The continuous analyte sensor system of claim 18, wherein the additional medical device comprises a blood pressure monitor.

20. The continuous analyte sensor system of claim 1, wherein the information obtained prior to implantation comprises sensitivity information of the continuous analyte sensor.

21. The continuous analyte sensor system of claim 1, wherein the information obtained prior to implantation comprises baseline information of the continuous analyte sensor.

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

a vascular access device configured for communication with a vascular system of a host;

a continuous analyte sensor configured for insertion into the host, wherein the continuous analyte sensor is configured to measure a concentration of an analyte within the vascular system of the host;

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

a fluid coupler configured to mate with the vascular access device; and

a first portion of a sensor electronics comprising a potentiostat integral with and wired to the fluid coupler.

23. The continuous analyte sensor system of claim 22, further comprising a second portion of the sensor electronics configured to process the sensor data received from the first portion of the sensor electronics, wherein the second portion of the sensor electronics are separable from the first portion of the sensor electronics.

24. The continuous analyte sensor system of claim 23, wherein the first portion of the sensor electronics and the second portion of the sensor electronics are operably coupled via a wired or wireless connection.

25. The continuous analyte sensor system of claim 22, wherein the analyte sensor is a glucose sensor.

26. The continuous analyte sensor system of claim 22, wherein the continuous analyte sensor is configured to at least partially reside within the vascular access device.

27. The continuous analyte sensor system of claim 26, wherein the vascular access device comprises the analyte sensor, the analyte sensor at least partially integrally incorporated on an interior surface of the vascular access device.

28. The continuous analyte sensor system of claim 22, wherein the computer system is further configured to automatically obtain calibration information.

29. The continuous analyte sensor system of claim 22, 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.

30. The continuous analyte sensor system of claim 22, 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.

31. The continuous analyte sensor system of claim 22, 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.

32. The continuous analyte sensor system of claim 22, wherein the analyte sensor comprises a working electrode, and wherein the working electrode is flexible.

33. The continuous analyte sensor system of claim 22, wherein the continuous analyte sensor comprises a first working electrode and an additional working electrode.

34. The continuous analyte sensor system of claim 33, wherein the first working electrode is configured to measure analyte and non-analyte related signals, and wherein the additional working electrode is configured to measure a non-analyte related signal.

35. The continuous analyte sensor system of claim 22, wherein at least a portion of the continuous analyte sensor is configured to float freely within the vascular access device.

36. The continuous analyte sensor system of claim 22, wherein the vascular access device comprises an anticoagulant coating.

37. The continuous analyte sensor system of claim 26, wherein the anticoagulant coating comprises heparin.

38. The continuous analyte sensor system of claim 22, wherein the continuous analyte sensor comprises an anticoagulant coating.

39. The continuous analyte sensor system of claim 38, wherein the anticoagulant coating comprises heparin.

40. The continuous analyte sensor system of claim 22, further comprising a fluid coupler configured to mate with the vascular access device.

41. The continuous analyte sensor system of claim 22, wherein the continuous analyte sensor system is operably coupled to an additional medical device.

42. The continuous analyte sensor system of claim 41, wherein the additional medical device comprises a blood pressure monitor.

43. The continuous analyte sensor system of claim 22, wherein the analyte sensor is a glucose sensor.

44. The continuous analyte sensor system of claim 22, wherein the continuous analyte sensor is configured to at least partially reside within the vascular access device.

45. The continuous analyte sensor system of claim 22, wherein the vascular access device comprises the analyte sensor, the analyte sensor at least partially integrally incorporated on an interior surface of the vascular access device.

46. The continuous analyte sensor system of claim 22, wherein the computer system is further configured to automatically obtain calibration information.

47. The continuous analyte sensor system of claim 22, 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.

48. The continuous analyte sensor system of claim 22, 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.

49. The continuous analyte sensor system of claim 22, 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.

50. The continuous analyte sensor system of claim 22, wherein the analyte sensor comprises a working electrode, and wherein the working electrode is flexible.

51. The continuous analyte sensor system of claim 22, wherein the continuous analyte sensor comprises a first working electrode and an additional working electrode.

52. The continuous analyte sensor system of claim 51, wherein the first working electrode is configured to measure analyte and non-analyte related signals, and wherein the additional working electrode is configured to measure a non-analyte related signal.

53. The continuous analyte sensor system of claim 22, wherein at least a portion of the continuous analyte sensor is configured to float freely within the vascular access device.

54. The continuous analyte sensor system of claim 22, wherein the vascular access device comprises an anticoagulant coating.

55. The continuous analyte sensor system of claim 54, wherein the anticoagulant coating comprises heparin.

56. The continuous analyte sensor system of claim 22, wherein the continuous analyte sensor comprises an anticoagulant coating.

57. The continuous analyte sensor system of claim 56, wherein the anticoagulant coating comprises heparin.

58. The continuous analyte sensor system of claim 22, further comprising a fluid coupler configured to mate with the vascular access device.