Analyte sensor

• US 8,774,886 B2
• Filed: 10/04/2006
• Issued: 07/08/2014
• 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
• Primary Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US11/543,490
• Publication Number:
  US 20080119704A1
• Time in Patent Office: 2,834 Days
• Field of Search: 600345-347, 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 system for measuring an analyte, the system comprising:

a fluid coupler comprising a distal end, a proximal end, and a fluid coupler lumen, wherein the distal end of the fluid coupler is configured to attach to a proximal end of a vascular access device to form a pathway for flow of blood and intravenous solution, wherein the pathway extends from the proximal end of the fluid coupler to a distal end of the vascular access device;

an analyte sensor that is configured to generate sensor data and configured to extend from the fluid coupler lumen to a lumen of the vascular access device;

a tubular structure comprising a tubular structure lumen, wherein the tubular structure is configured to cover, within the tubular structure lumen, at least a portion of the analyte sensor and configured to extend from the fluid coupler lumen to the vascular access device lumen, the tubular structure positioned within the fluid coupler lumen and vascular access device lumen, the tubular structure lumen having an outlet positioned between the distal end and the proximal end of the tubular structure; and

sensor electronics wired to the analyte sensor, at least a portion of the wired sensor electronics extending from the outlet of the tubular structure, the portion of the wired sensor electronics extending out of the fluid coupler from between the distal end and the proximal end of the fluid coupler, wherein the sensor electronics are configured to determine a concentration of an analyte within the vascular system.

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

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

4. The system of claim 1, further comprising the vascular access device, 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 to 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 at least one working 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, further comprising the vascular access device, wherein the vascular access device is a catheter.

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

17. The system of claim 16, 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.

18. 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.

19. The system of claim 1, further comprising a blood flow device, wherein the blood flow device is configured to withdraw blood from the host and return it to the host.

20. The system of claim 19, wherein the blood flow device is coupled to the proximal end of the fluid coupler.

21. The system of claim 1, wherein at least a portion of the pathway is coated with an anticoagulant.

22. The system of claim 21, wherein the analyte sensor is coated with an anticoagulant.

23. The system of claim 1, wherein the sensor electronics are disposed in part or in whole with the fluid coupler.

24. The system of claim 1, wherein a potentiostat is disposed on the fluid coupler.

25. The system of claim 1, wherein the analyte sensor is configured to extend through the lumen of the vascular access device and through the distal end of the vascular access device.

26. The system of claim 1, wherein the analyte sensor comprises a distal end, and wherein the distal end of the analyte sensor is configured to reside within the lumen of the vascular access device.

27. The system of claim 1, further comprising the vascular access device.

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

a fluid coupler comprising a distal end, a proximal end, and a fluid coupler lumen, wherein the distal end of the fluid coupler is configured to attach to a proximal end of a vascular access device to form a pathway for flow of blood and intravenous solution, wherein the pathway extends from the proximal end of the fluid coupler to a distal end of the vascular access device;

an analyte sensor that is configured to generate sensor data and configured to extend from the fluid coupler lumen to a lumen of the vascular access device;

a tubular structure comprising a tubular structure lumen and having a slot formed therein extending along the length of the tubular structure, wherein the tubular structure is configured to cover within the tubular structure lumen at least a portion of the analyte sensor and configured to extend from the fluid coupler lumen to the vascular access device lumen and positioned within the fluid coupler lumen and vascular access device lumen, the tubular structure lumen having an outlet positioned between the distal end and the proximal end of the tubular structure; and

sensor electronics wired to the analyte sensor, at least a portion of the wired sensor electronics extending from the outlet and the portion of the wired sensor electronics extending out of the fluid coupler from between the distal end and the proximal end of the fluid coupler, wherein the sensor electronics are configured to determine a concentration of an analyte within the vascular system.