Analyte sensor

• US 20080119704A1
• 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, Saint, Sean, Swanson, Vance, Quintana, Nelson
• Granted Patent: US 8,774,886 B2
• 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 configured for insertion communication with a vascular system of a host, wherein the vascular access device comprises an analyte sensor at least partially integrally incorporated therewith; and

sensor electronics operatively connected to the analyte sensor, wherein the sensor electronics are configured to measure a concentration of an analyte within the vascular system.

2. The system of claim 1, wherein the sensor electronics are configured to substantially continuously measure the analyte concentration.

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

4. 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.

5. The system of claim 1, wherein the analyte sensor comprises at least one working electrode configured measure a first signal.

6. The system of claim 5, wherein the first signal is substantially analyte related.

7. The system of claim 5, wherein the analyte sensor further comprises a second working electrode configured measure a second signal.

8. The system of claim 7, wherein the second signal is substantially non-analyte related.

9. The system of claim 7, wherein the sensor electronics are configured to process the second signal and the first signal to determine a concentration of an analyte.

10. The system of claim 5, wherein the analyte sensor further comprises a reference electrode.

11. The system of claim 10, wherein the reference electrode is located at a position remote from the reference electrode.

12. The system of claim 11, wherein the reference electrode is configured to be located outside of a blood stream of the host.

13. The system of claim 10, wherein the analyte sensor further comprises a counter electrode.

14. The system of claim 1, wherein the analyte sensor is configured to at least partially contact an in vivo blood stream of the host when the vascular access device is inserted therein.

15. The system of claim 1, wherein the analyte sensor is deposited on an exterior surface of the vascular access device.

16. The system of claim 15, wherein the analyte sensor is electroplated onto the exterior surface of the vascular access device.

17. The system of claim 1, wherein the analyte sensor is wired to at least a portion of the sensor electronics.

18. The system of claim 1, wherein the analyte sensor is wirelessly connected to at least a portion of the sensor electronics.

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

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

21. The system of claim 20, 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.

22. 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.

23. 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, wherein the vascular access device comprises an analyte sensor at least partially integrally incorporated therewith;

operatively connecting the analyte sensor to sensor electronics; and

measuring an analyte concentration in the host.

24. The method of claim 23, further comprising substantially continuously measuring an analyte concentration.

25. The method of claim 23, wherein the step of measuring an analyte concentration comprises measuring a glucose concentration.

26. The method of claim 23, wherein the analyte sensor comprises at least one working electrode, wherein the measuring step comprises measuring a first signal at the working electrode, wherein the first signal is substantially analyte-related.

27. The method of claim 26, wherein the analyte sensor further comprises a second working electrode, and wherein the measuring step further comprises measuring a second signal at the second working electrode, wherein the second signal is substantially non-analyte related.

28. The method of claim 27, further comprising processing the second signal and the first signal to determine a concentration of an analyte.

29. The method of claim 23, wherein the measuring step comprises measuring an analyte concentration in an in vivo blood stream of the host.

30. The method of claim 23, wherein the operatively connecting step comprises connecting the analyte sensor to at least a portion of the sensor electronics via a wired connection.

31. The method of claim 23, wherein the operatively connecting step comprises connecting the analyte sensor to at least a portion of the sensor electronics via a wireless connection.

32. A method for manufacturing an analyte sensor configured for measuring an analyte in a vascular system of a host, the method comprising:

providing a vascular access device; and

at least partially integrally incorporating an analyte sensor in the vascular access device or on a surface of the vascular access device.

33. The method of claim 32, wherein the step of at least partially integrally incorporating an analyte sensor comprises depositing at least one working electrode on an interior surface of the vascular access device or on an exterior surface of the vascular access device.

34. The method of claim 33, wherein the depositing step further comprises electroplating the working electrode onto the exterior surface of the vascular access device.

35. The method of claim 33, wherein the step of at least partially integrally incorporating an analyte sensor further comprises depositing a second working electrode on an interior surface of the vascular access device or on an exterior surface of the vascular access device.

36. The method of claim 33, wherein the step of at least partially integrally incorporating an analyte sensor further comprises depositing a reference electrode on an interior surface of the vascular access device or on an exterior surface of the vascular access device.

37. The method of claim 33, wherein the step of at least partially integrally incorporating an analyte sensor further comprises depositing a counter electrode on an interior surface of the vascular access device or on an exterior surface of the vascular access device.

38. The method of claim 33, wherein the surface of the vascular access device is selected from the group consisting of an exterior surface, an interior surface, and a tip surface.

39. The method of claim 33, wherein the step of at least partially integrally incorporating an analyte sensor further comprises forming a reference electrode at a location remote from the working electrode.