Analyte sensor

• US 20080119703A1
• Filed: 10/04/2006
• Published: 05/22/2008
• Est. Priority Date: 10/04/2006
• Status: Abandoned Application

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark, Petisce, James R., Saint, Sean, Swanson, Vance
• Application Number:
  US11/543,396
• Publication Number:
  US 20080119703A1
• Time in Patent Office: Days
• US Class Current: 600/347
• 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 system for measuring an analyte, the system comprising:

a vascular access device in communication with a vascular system of a host; and

an analyte sensor configured to extend within the vascular access device, wherein the analyte sensor is configured to measure a concentration of an analyte within the vascular system.

2. The system of claim 1, wherein the analyte sensor is configured to extend through the vascular access device and into a blood stream of the host.

3. The system of claim 1, wherein the vascular access device is a catheter.

4. The system of claim 1, wherein the vascular access device is configured for insertion into a vein of the host.

5. The system of claim 1, wherein the vascular access device is configured for insertion into an artery of the host.

6. The system of claim 1, wherein the vascular access device is configured to operatively couple to a pressure transducer for measurement of a blood pressure of the host.

7. The system of claim 1, wherein the vascular access device is configured to operatively couple to a blood chemistry analysis device for measuring a blood chemistry of the host.

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

9. The system of claim 1, further comprising a sheath configured to protect the analyte sensor during insertion of the analyte sensor into the catheter.

10. The system of claim 9, wherein the sheath comprises a slot configured to allow the release of the analyte sensor therefrom.

11. The system of claim 1, further comprising a fluid coupler having first end and second end, wherein the fluid coupler is configured to mate with the vascular access device on the first end, and wherein at least a portion of the analyte sensor extends through the fluid coupler or is housed within the fluid coupler.

12. The system of claim 11, wherein the fluid coupler comprises sensor electronics formed thereon.

13. The system of claim 12, wherein the sensor electronics comprise a potentiostat.

14. The system of claim 11, wherein the fluid coupler is configured to mate with a medical device on the second end.

15. The system of claim 14, wherein the medical device comprises at least one device selected from the group consisting of a blood pressure monitor, a blood chemistry device, and a dialysis bypass machine.

16. The system of claim 1, wherein the analyte sensor is configured to extend through the vascular access device and into a blood stream of the host by from about 0.010 inches to about 1 inch.

17. The system of claim 1, wherein the vascular access device and the analyte sensor are configured to indwell within a blood stream of the host in vivo.

18. The system of claim 1, further comprising sensor electronics operatively connected to the analyte sensor.

19. The system of claim 18, wherein the analyte sensor comprises at least one working electrode configured to measure a first signal.

20. The system of claim 19, wherein the first signal is substantially analyte related.

21. The system of claim 19, wherein the analyte sensor further comprises a second working electrode configured to measure a second signal.

22. The system of claim 21, wherein the second signal is substantially non-analyte related.

23. The system of claim 22, wherein the sensor electronics are configured to process the second signal and the first signal to determine a concentration of an analyte.

24. The system of claim 19, further comprising a reference electrode.

25. The system of claim 24, wherein the reference electrode is located at a position remote from the working electrode.

26. The system of claim 25, further comprising a fluid coupler having first end and a second end, wherein the fluid coupler is configured to mate with the catheter on the first end, wherein at least a portion of the analyte sensor extends through the fluid coupler or is housed within the fluid coupler, and wherein the reference electrode is located at a position proximal to the fluid coupler or within the fluid coupler.

27. The system of claim 1, wherein an end of the analyte sensor that extends into a blood stream of the host comprises an enlarged area.

28. The system of claim 1, wherein a substantial portion of the analyte sensor has a diameter of less than about 0.008 inches.

29. The system of claim 1, wherein a substantial portion of the analyte sensor has a diameter of less than about 0.004 inches.

30. The system of claim 1, wherein the analyte sensor further comprises a bioinert material or a bioactive agent incorporated therein or thereon.

31. The system of claim 30, wherein the bioactive agent comprises at least one agent selected from the group consisting of vitamin K antagonists, heparin group anticoagulants, platelet aggregation inhibitors, enzymes, direct thrombin inhibitors, Dabigatran, Defibrotide, Dermatan sulfate, Fondaparinux, and Rivaroxaban.

32. The 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.

33. The 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.

34. The 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.

35. The 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 reference electrode is helically wound around the working electrode.

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

37. The system of claim 1, wherein the analyte sensor comprises a working electrode, and wherein the working electrode has a variable stiffness.

38. The system of claim 1, 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.

39. A method for measuring an analyte in a blood stream of a host, the method comprising:

inserting a vascular access device into communication with a blood stream of a host; and

inserting an analyte sensor into the vascular access device, wherein the analyte sensor measures a concentration of an analyte within the blood stream of the host.

40. The method of claim 39, wherein the analyte sensor extends through the vascular access device and into the blood stream.

41. The method of claim 39, wherein the vascular access device is a catheter.

42. The method of claim 39, wherein the vascular access device is inserted into a vein of the host.

43. The method of claim 39, wherein the vascular access device is inserted into an artery of the host.

44. The method of claim 39, further comprising coupling a pressure transducer to the analyte sensor.

45. The system of claim 39, further comprising coupling a blood chemistry analysis device to the analyte sensor.

46. The method of claim 39, wherein the analyte sensor measures glucose.

47. The method of claim 39, wherein the analyte sensor comprises a fluid coupler for housing the analyte sensor or supporting the analyte sensor, and wherein the method further comprises mating the fluid coupler with the vascular access device on a first end of the fluid coupler.

48. The method of claim 47, further comprising mating the fluid coupler with a medical device on a second end of the fluid coupler.

49. The method of claim 48, further comprising measuring at least one other parameter with the medical device, wherein the parameter is selected from the group consisting of blood pressure and blood chemistry.

50. The method of claim 39, wherein the step of inserting the analyte sensor comprises inserting the analyte sensor beyond an in vivo end of the vascular access device by from about 0.010 inches to about 1 inch.

51. The method of claim 39, wherein the vascular access device and the analyte sensor are configured to indwell within a blood stream of the host in vivo.

52. The method of claim 39, further comprising sensor electronics operatively connected to the analyte sensor, wherein the method further comprises utilizing sensor electronics to measure a concentration of an analyte within the host.

53. The method of claim 52, wherein the analyte sensor comprises at least one working electrode, and wherein the method further comprises measuring a first signal at the working electrode, and wherein the first signal is substantially analyte-related.

54. The method of claim 53, wherein the analyte sensor further comprises a second working electrode, and wherein the method further comprises measuring a second signal at the second working electrode.

55. The method of claim 54, wherein the second signal is substantially non-analyte-related.

56. The method of claim 55, further comprising processing the second signal and the first signal to determine a concentration of an analyte.

57. The method of claim 39, further comprising avoiding piercing of a blood vessel during sensor insertion into the blood vessel by providing an enlarged area at an insertion end of the analyte sensor.

58. The method of claim 39, further comprising substantially preventing clotting or thrombosis proximal to or on the analyte sensor within the blood stream.