Analyte sensor

• US 7,775,975 B2
• Filed: 03/26/2007
• Issued: 08/17/2010
• Est. Priority Date: 10/04/2006
• Status: Active Grant

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

1. A system for measuring an analyte, the system comprising:

a vascular access device configured to be in communication with a circulatory system of a host, wherein the vascular access device comprises a catheter and tubing;

an analyte sensor configured to reside within the vascular access device, wherein the analyte sensor is configured to measure a concentration of an analyte within the circulatory system; and

a flow control device configured to draw back a volume of from about 15 μ

l to about 150 μ

l of a sample from the host'"'"'s circulatory system into the catheter, but not into the tubing, and return the sample back to the host'"'"'s circulatory system.

8. The system of claim 1, further comprising a bag containing a fluid.

9. The system of claim 8, further comprising a flow regulator configured to regulate a flow of the fluid.

10. The system of claim 1, further comprising a local analyzer.

11. The system of claim 10, wherein the local analyzer comprises a potentiostat.

12. The system of claim 10, wherein the local analyzer comprises a data processing module.

13. The system of claim 10, wherein the local analyzer comprises a data storage module.

14. The system of claim 1, further comprising a remote analyzer.

15. The system of claim 14, wherein the remote analyzer comprises a touch screen.

16. The system of claim 14, wherein the remote analyzer is configured to control the flow control device.

17. The system of claim 14, wherein the remote analyzer is detachably operably connected to a local analyzer.

18. The system of claim 14, wherein the remote analyzer comprises a data processing module.

19. The system of claim 14, wherein the remote analyzer comprises a data storage module.

20. The system of claim 14, wherein the flow control device comprises a processor configured to control the flow control device, and wherein the processor is operably connected to the remote analyzer.

21. The system of claim 1, wherein the flow control device comprises a pump.

22. The system of claim 1, wherein the sample volume is from about 25 μ

l to about 100 μ

l.

23. The system of claim 1, wherein the analyte comprises at least one analyte selected from the group consisting of glucose, O₂, CO₂, PCO₂, PO₂, potassium, sodium, pH, lactate, urea, bilirubin, creatinine, hematocrit, and combinations thereof.

24. The system of claim 1, wherein the analyte is glucose.

25. The system of claim 1, wherein the sensor is located within the catheter.

26. The system of claim 1, wherein the catheter is 21 gauge or smaller.

27. The system of claim 1, wherein the vascular access device further comprises a fluid coupler connectable to the catheter.

28. The system of claim 27, wherein the sensor is located within the fluid coupler.

29. The system of claim 28, wherein the flow control device is configured to draw back the sample volume into the fluid coupler, but substantially no farther than the fluid coupler.

30. The system of claim 27, wherein the sensor is held by the fluid coupler.

31. The system of claim 1, wherein the catheter is at least one of a venous catheter or an arterial catheter.

32. The system of claim 1, wherein the catheter is a Swann Gantz catheter.

33. The system of claim 1, wherein the catheter is a multi-lumen catheter, and wherein the sensor is located in one of the catheter'"'"'s lumens.

34. The system of claim 1, wherein the sensor is at least one of integrally formed or integrally incorporated onto a surface of the catheter.

35. The system of claim 1, wherein the sensor is located on a tip of the catheter.

36. The system of claim 1, wherein the sensor is integrally incorporated with the catheter.

37. The system of claim 1, wherein the flow control device comprises a gravity-fed valve.

2. A system for measuring an analyte, the system comprising:

a vascular access device configured to be in communication with a circulatory system of a host;

an analyte sensor configured to reside within the vascular access device, wherein the analyte sensor is configured to measure a concentration of an analyte within the circulatory system; and

a gravity-fed rotating pinch valve configured to regulate exposure of the sensor intermittently between an infusion solution and a sample from the host'"'"'s circulatory system, wherein the gravity-fed rotating pinch valve is configured to draw back a volume of less than about 150 μ

l of a sample from the host'"'"'s circulatory system into the vascular access device.

3. The system of claim 2, wherein the valve comprises a first position and a second position.

4. The system of claim 3, wherein the valve is configured to move between the first position and the second position over a time period of from about 0.5 seconds to about 10 seconds.

5. The system of claim 3, wherein the valve is configured to meter a flow through the vascular access device at a predetermined flow rate.

38. The system of claim 2, wherein the rotating pinch valve is configured to draw blood into the vascular access device at a flow rate of from about 0.001 ml/min to about 2 ml/min.

39. The system of claim 38, wherein the flow rate is from about 0.001 ml/min to about 0.2 ml/min.

40. The system of claim 2, wherein the volume of from about 15 μ

l to about 100 μ

l.

41. The system of claim 3, wherein the system is configured to push fluid through the vascular access device during movement of the valve from the first position to the second position.

42. The system of claim 41, wherein the system is configured to draw back the sample into the vascular access device during movement of the valve from the second position to the first position.

6. A system for measuring an analyte, the system comprising:

a vascular access device configured to be in communication with a circulatory system of a host;

an analyte sensor configured to reside within the vascular access device, wherein the analyte sensor is configured to measure a concentration of an analyte within the circulatory system; and

a valve comprising a first position and a second position that is different from the first position, wherein the system is configured such that about 150 microliters or less of a fluid passes through the vascular access device during movement of the valve at a predetermined rate between the first position and the second position during predetermined amount of time, wherein the system is configured to push fluid through the vascular access device during movement of the valve from the first position to the second position, and wherein the system is configured to draw back a sample into the vascular access device during movement of the valve from the second position to the first position.

7. The system of claim 6, wherein the valve is configured such that about 50 microliters or less of a fluid passes through the vascular access device during the movement of the valve between the first position and the second position.

43. A system for measuring an analyte, the system comprising:

a vascular access device configured to be in communication with a circulatory system of a host;

an analyte sensor configured to reside within the vascular access device, wherein the analyte sensor is configured to measure a concentration of an analyte within the circulatory system; and

a flow control device configured to draw back a volume of from about 15 μ

l to about 150 microliters of blood from the host'"'"'s circulatory system to cover at least a portion of the sensor and return at least a portion of the blood back to the host'"'"'s circulatory system.

44. The system of claim 43, wherein the flow control device is configured to draw back less than about 50 microliters of blood from the host'"'"'s circulatory system to cover at least a portion of the sensor.

45. The system of claim 43, wherein the analyte is glucose.

46. The system of claim 43, wherein the vascular access device comprises a catheter, and wherein the sensor is located within the catheter.

47. The system of claim 46, wherein the catheter is 21 gauge or smaller.

48. The system of claim 43, wherein the vascular access device comprises a catheter and a fluid coupler connectable to the catheter.

49. The system of claim 48, wherein the sensor is located within the fluid coupler.

50. The system of claim 48, wherein the flow control device is configured to draw back the sample volume into the fluid coupler, but substantially no farther than the fluid coupler.

51. The system of claim 48, wherein the sensor is held by the fluid coupler.

52. The system of claim 43, wherein the vascular access device comprises at least one of a venous catheter or an arterial catheter.

53. The system of claim 43, wherein the vascular access device comprises a Swann Gantz catheter.

54. The system of claim 43, wherein the vascular access device comprises a multi-lumen catheter, and wherein the sensor is located in one of the catheter'"'"'s lumens.

55. The system of claim 43, wherein the sensor is at least one of integrally formed and integrally incorporated onto a surface of the vascular access device.

56. The system of claim 43, wherein the vascular access device comprises a catheter, and wherein the sensor is located on a tip of the catheter.

57. The system of claim 43, wherein the sensor is integrally incorporated with the vascular access device.

58. The system of claim 43, wherein the flow control device is configured to draw back the blood at a first flow rate of from about 0.001 ml/min to about 2 ml/min.

59. The system of claim 58, wherein the first flow rate is from about 0.02 ml/min to about 0.35 ml/min.

60. The system of claim 58, wherein the first flow rate is configured to substantially block mixing of an infusion solution and a sample.

61. The system of claim 43, wherein the flow control device is configured to pass an infusion solution at a second flow rate of from about 0.001 ml/min to about 2 ml/min.

62. The system of claim 61, wherein the second flow rate is from about 0.02 ml/min to about 0.35 ml/min.

63. The system of claim 61, wherein the second flow rate is configured to allow a temperature of the infusion solution to substantially equilibrate with a temperature of the host.

64. The system of claim 43, wherein the flow control device comprises a valve comprising a first position and a second position.

65. The system of claim 64, wherein the valve is configured to move between the first position and the second position over a time period of from about 0.5 seconds to about 10 seconds.

66. The system of claim 64, wherein the valve is configured to meter a flow through the vascular access device at a predetermined flow rate during movement of the valve between the first position and the second position.

67. The system of claim 66, wherein the flow rate is from about 0.001 ml/min to about 0.2 ml/min.

68. The system of claim 64, wherein the valve is configured to push a fluid through the vascular access device during movement of the valve from the first position to the second position.

69. The system of claim 64, wherein the valve is configured to draw back a fluid into the vascular access device during movement of the valve from the second position to the first position.