Analyte sensor

• US 20060142651A1
• Filed: 02/22/2006
• Published: 06/29/2006
• Est. Priority Date: 07/13/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark, Petisce, James R., Woo, Kum Ming, Saint, Sean, Nolting, John
• Granted Patent: US 8,615,282 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 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2560/028 Arrangements to prevent overuse, e.g. by counting the number of uses
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14517 for sweat
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/6832 using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61L 2/12 Microwaves
• CPC Class Codes: A61L 2/206 : Ethylene oxide
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
• CPC Class Codes: Y10T 29/49004 : including measuring or testing of device or component part

Abstract

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Claims

1. A sensor for transcutaneous measurement of an analyte in a host, the sensor comprising:

at least one electrode formed from a conductive material; and

a membrane disposed on an electroactive portion of the electrode, wherein the membrane is configured to control an influx of the analyte therethrough, and wherein the membrane comprises a substantially non-smooth outer surface.

2. The sensor of claim 1, wherein the substantially non-smooth surface appears under magnification to resemble a super-positioning of disc shaped objects.

3. The sensor of claim 1, wherein the disc shaped objects comprise a rounded shape.

4. The sensor of claim 1, wherein the disc shaped objects have an average diameter of from about 5 microns to about 250 microns.

5. The sensor of claim 1, wherein the membrane further comprises an enzyme domain.

6. The sensor of claim 5, wherein the membrane further comprises an interference domain.

7. The sensor of claim 5, wherein the membrane further comprises an electrode domain.

8. The sensor of claim 1, wherein the membrane is at least partially formed by a vapor deposition coating process.

9. The sensor of claim 8, wherein the vapor deposition coating process comprises a physical vapor deposition coating process.

10. The sensor of claim 9, wherein the physical vapor deposition coating process comprises ultrasonic vapor deposition.

11. The sensor of claim 1, wherein the membrane substantially resists ascorbate flux therethrough.

12. The sensor of claim 1, wherein the electrode comprises a wire comprising a conductive material, and wherein the sensor is configured for substantially continuous measurement of glucose in a host.

13. A method for manufacturing a transcutaneous analyte sensor, the method comprising the steps of:

providing at least one electrode comprising an electroactive portion; and

applying a membrane to the electroactive portion, wherein at least one layer of the membrane is applied by vapor deposition.

14. The method of claim 13, wherein the vapor deposition comprises physical vapor deposition.

15. The method of claim 14, wherein the physical vapor deposition comprises ultrasonic vapor deposition.

16. The method of claim 13, wherein the layer of the membrane is deposited in a vacuum chamber.

17. The method of claim 16, wherein the layer is configured to resist flow of the analyte therethrough.

18. The method of claim 13, wherein at least one layer of the membrane is applied using an ultrasonic nozzle.

19. The method of claim 18, wherein the layer is configured to resist flow of the analyte therethrough.

20. The method of claim 13, wherein the step of applying a membrane comprises applying an enzyme domain.

21. The method of claim 20, wherein the step of applying an enzyme domain comprises applying an enzyme domain by dip coating.

22. The method of claim 13, wherein the step of applying a membrane comprises applying an electrode domain.

23. The method of claim 22, wherein the step of applying the electrode domain comprises applying the electrode domain by dip coating.

24. The method of claim 13, wherein the electrode comprises a wire comprising a conductive material, and wherein the sensor is configured for substantially continuous measurement of glucose in a host.

25. A method for manufacturing a plurality of transcutaneous analyte sensors, the method comprising:

providing a plurality of electrodes, each electrode comprising an electroactive portion;

placing the plurality of electrodes into a vacuum chamber; and

vapor depositing at least one membrane layer thereon.

26. The method of claim 25, wherein the membrane layer is configured to control influx of an analyte therethrough.

27. The method of claim 25, wherein an in vitro sensitivity of the plurality of sensors deviates from a median in vitro sensitivity by less about 20%.

28. The method of claim 25, wherein an in vitro sensitivity of the plurality of sensors deviates from a median in vitro sensitivity by less about 16%.

29. The method of claim 25, wherein an in vitro sensitivity of the plurality of sensors deviates from a median in vitro sensitivity by less about 12%.

30. The method of claim 25, further comprising:

curing the membrane layer.

31. The method of claim 30, wherein the curing step comprises placing a plurality of electrodes, each comprising the membrane layer, into a vacuum oven.

32. The method of claim 30, wherein the curing step comprises placing a plurality of electrodes, each comprising the membrane layer, into a convection oven.

33. The method of claim 30, wherein the curing step comprises placing a plurality of electrodes, each comprising the membrane layer, into a variable frequency microwave oven.

34. The method of claim 25, wherein each electrode comprises a wire comprising a conductive material, and wherein each sensor is configured for substantially continuous measurement of glucose in a host.