ANALYTE SENSOR LAYERS AND METHODS RELATED THERETO

• US 20120283537A1
• Filed: 10/28/2010
• Published: 11/08/2012
• Est. Priority Date: 10/30/2009
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Petisce, James R., Oviatt, Henry W.
• Application Number:
  US13/503,745
• Publication Number:
  US 20120283537A1
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: C12Q 1/002 Electrode membranes

Abstract

Sensors for measuring an analyte in a subject comprising at least one electrode having an electroactive surface, at least one interferent-reducing layer comprising vinyl ester monomeric units disposed distally from the electroactive surface, an enzyme layer disposed distally from the electroactive surface and a flux-limiting membrane disposed over the at least one interferent-reducing layer and the enzyme layer. Methods of measuring an analyte in a subject comprising providing the electrochemical analyte sensor, contacting a sample comprising an analyte and an interferent with the at least one interferent-reducing layer comprising vinyl ester monomeric units, and measuring the analyte, where the amount of interferent reaching the electroactive surface is reduced.

Claims

1. An electrochemical analyte sensor comprising:

at least one electrode having an electroactive surface;

at least one interferent-reducing layer comprising vinyl ester monomeric units disposed distally from the electroactive surface;

an enzyme layer disposed distally from the electroactive surface; and

.

a flux limiting membrane disposed over the at least one interferent-reducing layer and the enzyme layer.

2. A sensor of claim 1, wherein the at least one interferent-reducing layer is disposed more distally from the electroactive surface than the enzyme layer.

3. A sensor of claim 1, wherein the enzyme layer is disposed more distally from the electroactive surface than the at least one interferent-reducing layer.

4. A sensor of claim 1, wherein the enzyme layer is positioned between at least two interferent-reducing layers, at least one interferent layer comprising vinyl ester monomeric units.

5. A sensor of any one of the claims 1-4, wherein the at least one interferent-reducing layer is a poly (ethylene-co-vinyl acetate).

6. A sensor of claim 5, wherein the at least one interferent-reducing layer comprises a wt. % vinyl acetate content of 33 or less.

7. A sensor of any one of the claims 1-4, wherein the at least one interferent-reducing layer comprises:

a mixture of poly (ethylene-co-vinyl acetate) polymers, independently having a wt. % vinyl acetate content of about 12 and about 18;

a mixture of poly (ethylene-co-vinyl acetate) polymers, independently having a wt. % vinyl acetate content of about 12 and about 25;

a mixture of poly (ethylene-co-vinyl acetate) polymers, independently having a wt. % vinyl acetate content of about 18 and about 25;

a mixture of poly (ethylene-co-vinyl acetate) polymers, independently having a wt. % vinyl acetate content of about 12 and 33;

a mixture of poly (ethylene-co-vinyl acetate) polymers, independently having a wt. % vinyl acetate content of about 18 and 33;

a mixture of poly (ethylene-co-vinyl acetate) polymers, independently having a wt. % vinyl acetate content of about 25 and 33;

or

a mixture of poly (ethylene-co-vinyl acetate) polymers, independently having a wt. % vinyl acetate content of 33 or less.

8. A sensor of any one of the claims 1-4, wherein the at least one interferent-reducing layer comprises a poly (ethylene-co-vinyl acetate) having a wt. % vinyl acetate content of about 18 or less.

9. A sensor of any one of the claims 1-4, further comprising a reference electrode, a counter electrode, an auxiliary electrode, or combinations thereof, having disposed thereon at least one anti-fouling layer.

10. A sensor of any one of the claims 1-4, wherein the enzyme layer comprises a hydrophilic polymer-enzyme composition.

11. A sensor of any one of the claims 1-4, wherein the enzyme layer comprises a hydrophilic polymer-glucose oxidase composition, wherein the hydrophilic polymer-enzyme composition comprises a material selected from the group consisting of poly-N-vinylpyrrolidone, poly-N-vinyl-3-ethyl-2-pyrrolidone, poly-N-vinyl-4,5-dimethyl-2-pyrrolidone, polyvinylimidazole, poly-N-N-dimethylacrylamide, polyacrylamide, and copolymers thereof.

12. A sensor of claim 11, wherein the flux limiting membrane is selected from polyurethanes, vinyl polymers, polyethers, polyesters, polyamides, rack-etched polycarbonates, polysiloxanes, polycarbosiloxanes, celluloses, protein-based materials, and mixtures or combinations thereof.

13. A sensor of claim 11, wherein the flux limiting membrane is a poly (ethylene-co-vinyl acetate) comprising about 40 wt. % vinyl acetate.

14. An electrochemical analyte sensor comprising:

at least one electrode having an electroactive surface;

a poly (ethylene-co-vinyl acetate) layer disposed distally from the electroactive surface, the poly (ethylene-co-vinyl acetate) having a wt. % vinyl acetate content of 33 or less;

an enzyme layer disposed distally from the poly (ethylene-co-vinyl acetate) having a wt. % vinyl acetate content of 33 or less, wherein the enzyme layer comprises a mixture of glucose oxidase and poly-N-vinylpyrrolidone; and

a poly (ethylene-co-vinyl acetate) layer having a wt. % vinyl acetate content of more than 33 disposed over the enzyme layer.

15. A method of measuring an analyte in a subject, the method comprising:

providing a electrochemical analyte sensor comprising;

(i) at least one electrode having an electroactive surface;

(ii) at least one interferent-reducing layer comprising vinyl ester monomeric units disposed distally from the electroactive surface;

(iii) an enzyme layer disposed distally from the electroactive surface; and

(iv) a flux limiting layer disposed over the at least one interferent-reducing layer and the enzyme layer;

contacting the electrochemical analyte sensor with a sample from a subject;

wherein an amount of interferent present in the sample reaching the electroactive surface is reduced.

16. A method of claim 15, wherein the at least one interferent-reducing layer comprising vinyl ester monomeric units is disposed more distally from the electroactive surface than the enzyme layer.

17. A method of claim 15, wherein the enzyme layer is disposed more distally from the electroactive surface than the at least one interferent-reducing layer.

18. A method of claim 15, wherein the enzyme layer is positioned between at least two interferent-reducing layers each comprising vinyl ester monomeric units.

19. A method of any one of the claims 15-18, wherein the at least one interferent-reducing layer is a poly (ethylene-co-vinyl acetate) having a wt. % vinyl acetate content of 33 or less.

20. A method of any one of the claims 15-18, wherein the at least one interferent-reducing layer is a poly (ethylene-co-vinyl acetate) having a wt. % vinyl acetate content of about 18 or less.

21. A method of any one of the claims 15-18, wherein the flux limiting membrane is a poly (ethylene-co-vinyl acetate) comprising about 40 wt. % vinyl acetate.

22. A method of any one of the claims 15-18, wherein the sample is in vivo intravenous blood of a subject.

23. A method of any one of the claims 15-18, wherein the electrochemical analyte sensor is disposed in a catheter.

24. A method of any one of the claims 15-18, further comprising a reference electrode, a counter electrode, an auxiliary electrode, or combinations thereof, having disposed thereon at least one anti-fouling layer.