ANALYTE SENSOR

• US 20070163880A1
• Filed: 03/01/2007
• Published: 07/19/2007
• Est. Priority Date: 07/13/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark, Nolting, John, Petisce, James, Woo, Kum
• Granted Patent: US 8,313,434 B2
• Time in Patent Office: Days
• US Class Current: 204/403.60
• 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 and associated methods of manufacture. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host and associated methods of manufacture.

Claims

1. A continuous glucose sensor for measurement of glucose in a host, the sensor comprising:

at least one electrode comprising a conductive material; and

a membrane system disposed on an electroactive portion of the electrode, wherein the membrane system comprises a smooth outer surface formed by a vapor deposition process,

wherein, for a time period of at least about one day, the membrane system is biocompatible and is configured to provide a linear response to glucose concentrations from about 40 mg/dL to about 400 mg/dL.

2. The sensor of claim 1, wherein the time period is at least about 3 days.

3. The sensor of claim 1, wherein the time period is at least about 7 days.

4. The sensor of claim 1, further comprising sensor electronics operably connected to the electrode and configured to measure a current flow produced by the electrode, wherein the sensor is configured to have a glucose sensitivity of from about 1 pA/mg/dL to about 100 pA/mg/dL.

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

6. The sensor of claim 1, wherein the membrane system further comprises an interference domain.

7. The sensor of claim 1, wherein the membrane system further comprises an electrode domain.

8. The sensor of claim 1, wherein the smooth outer surface is at least partially formed under reduced pressure.

9. The sensor of claim 8, wherein the membrane system is at least partially formed by physical vapor deposition.

10. The sensor of claim 1, wherein the membrane system comprises a discontinuous resistance domain configured to resist flow of glucose therethrough.

11. A method for manufacturing a transcutaneous glucose sensor, the method comprising the step of:

applying a membrane system to an electroactive portion of at least one electrode, wherein the membrane system comprises a smooth outer surface formed by vapor deposition, and

wherein, for a time period of at least about one day, the membrane system is biocompatible and is configured to provide a linear response to glucose concentrations from about 40 mg/dL to about 400 mg/dL.

12. The method of claim 11, wherein the outer surface is formed under reduced pressure.

13. The sensor of claim 11, wherein the time period is at least about 3 days.

14. The sensor of claim 11, wherein the time period is at least about 7 days.

15. The method of claim 11, wherein vapor deposition comprises physical vapor deposition.

16. The method of claim 11, wherein vapor deposition comprises ultrasonic vapor deposition.

17. The method of claim 11, wherein the membrane system comprises a resistance domain configured to resist a flow of glucose therethrough.

18. The method of claim 11, wherein the resistance domain is formed by a multi-step deposition process comprising a first step and a second step.

19. The method of claim 18, wherein the first step comprises applying a layer having a substantially non-smooth surface.

20. The method of claim 19, wherein the second step comprises applying a layer having a smooth surface over the substantially non-smooth surface, and wherein the smooth surface is the smooth outer surface.

21. The method of claim 20, wherein the first step and the second step each independently comprise depositing a layer, and wherein the layer applied in the second step has a higher solvent content at a time of deposition than the layer applied in the first step.