ANALYTE SENSORS HAVING A SIGNAL-TO-NOISE RATIO SUBSTANTIALLY UNAFFECTED BY NON-CONSTANT NOISE

• US 20130131478A1
• Filed: 01/02/2013
• Published: 05/23/2013
• Est. Priority Date: 07/25/2003
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Simpson, Peter C., Boock, Robert J., Petisce, James R., Brister, Mark C., Woo, Kum Ming, Nguyen, Lisa, Brunner, Seth R., Chee, Arthur, Nicholas, Melissa A., Wightlin, Matthew D., Pryor, Jack, Markovic, Dubravka, Rixman, Monica A.
• Granted Patent: US 9,763,609 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• 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 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• 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 5/6848 Needles
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal

Abstract

Systems and methods of use involving sensors having a signal-to-noise ratio that is substantially unaffected by non-constant noise are provided for continuous analyte measurement in a host. In some embodiments, a continuous analyte measurement system is configured to be wholly, transcutaneously, intravascularly or extracorporeally implanted.

Claims

1. An electrochemical continuous glucose sensor configured for implantation in a host, the glucose sensor comprising:

an electrode configured to measure a signal indicative of a glucose concentration of a host, wherein the signal comprises a glucose-related component and a non-glucose related component; and

a membrane covering at least a portion of the electrode, wherein the membrane is configured to reduce passage of an interfering species therethrough, whereby the non-glucose-related component of the signal is less than about 20% of the signal over a period of at least one day;

wherein the glucose sensor has a sensitivity to glucose of from about 25 pA/mg/dL to about 500 pA/mg/dL.

2. The glucose sensor of claim 1, wherein the interfering species has an oxidation potential that overlaps with an oxidation potential of a measured species indicative of the concentration of the analyte.

3. The glucose sensor of claim 1, wherein the measured species is a product of an enzymatic reaction between glucose and an enzyme and is measured by the electrode.

4. The glucose sensor of claim 1, wherein the membrane comprises a silicone-containing polymer.

5. The glucose sensor of claim 4, wherein the silicone-containing polymer is a polysiloxanes.

6. The glucose sensor of claim 4, wherein the silicone-containing polymer is a polycarbosiloxane.

7. The glucose sensor of claim 4 wherein the silicone-containing polymer is a copolymer comprising a silicone segment and a polyurethane segment.

8. The glucose sensor of claim 1, wherein the membrane comprises a fluorocarbon-based material.

9. The glucose sensor of claim 1, wherein the non-glucose-related component is less than about 10% of the signal over a time period of at least about one day.

10. The glucose sensor of claim 1, wherein the glucose sensor has a sensitivity to glucose of from about 25 pA/mg/dL to about 100 pA/mg/dL.

11. The glucose sensor of claim 1, wherein the glucose sensor comprises an enzyme configured to react with glucose.

12. An electrochemical continuous glucose sensor configured for implantation in a host, the glucose sensor comprising:

an electrode configured to measure a signal indicative of a glucose concentration of a host, wherein the signal comprises a glucose-related component and a non-glucose related component; and

an enzyme-containing membrane covering at least a portion of the electrode, wherein the enzyme-containing membrane comprises an outer domain comprising a discontinuously hydrophilic surface, wherein the outer domain comprises at least about 5 wt. % of a hydrophilic component.

13. The glucose sensor of claim 12, wherein the discontinuously hydrophilic outer domain comprises a blend comprising a silicone-containing polymer and a hydrophilic polymer.

14. The glucose sensor of claim 12, wherein the membrane comprises a fluorocarbon-based material.

15. The glucose sensor of claim 12, wherein the hydrophilic polymer is a copolymer of poly(ethylene oxide) and poly(propylene oxide).

16. The glucose sensor of claim 12, wherein the discontinuously hydrophilic outer domain comprises a polyurethane-based domain that has been surface-treated with a polymer containing hydrophilic moieties

17. The glucose sensor of claim 12, wherein the outer domain comprises at least about 15 wt. % of a hydrophilic component.

18. The glucose sensor of claim 12, wherein the outer domain comprises at least about 25 wt. % of a hydrophilic component.

19. The glucose sensor of claim 12, wherein the glucose sensor has a sensitivity to glucose of from about 25 pA/mg/dL to about 500 pA/mg/dL.

20. The glucose sensor of claim 12, wherein the glucose sensor has a sensitivity to glucose of from about 25 pA/mg/dL to about 100 pA/mg/dL.

21. The glucose sensor of claim 12, wherein the glucose sensor comprises an enzyme configured to react with glucose.

22. The glucose sensor of claim 12, wherein the outer domain is configured to control a flux of glucose therethrough.