Membrane Layer for Electrochemical Biosensor and Method of Accommodating Electromagnetic and Radiofrequency Fields

• US 20100160756A1
• Filed: 12/11/2009
• Published: 06/24/2010
• Est. Priority Date: 12/24/2008
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Oviatt, Henry W., Petisce, James R.
• Application Number:
  US12/636,117
• Publication Number:
  US 20100160756A1
• 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 5/14542 for measuring blood gases A61B5/14551 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 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: C12Q 1/002 Electrode membranes

Abstract

A method comprising providing an in vivo electrochemical biosensor, the biosensor comprising an electrode surface, a flux-limiting layer covering at least a portion of the electrode surface, covering at least a portion of the flux-limiting layer with a hydrophilic polymer membrane, and preventing or eliminating disruption of the output signal of the electrochemical biosensor by an external EMF or external RF source during in vivo use of the biosensor in a subject.

Claims

1. A method comprising:

providing an in vivo electrochemical biosensor, the biosensor comprising;

an electrode surface;

a flux-limiting layer covering at least a portion of the electrode surface;

covering at least a portion of the flux-limiting layer with a hydrophilic polymer membrane; and

reducing disruption of the output signal of the electrochemical biosensor by an external EMF or external RF source during in vivo use of the biosensor.

2. The method of claim 1, wherein the external EMF or external RF source is generated by an electrosurgical unit (ESU).

3. The method of claim 2, wherein the electrosurgical unit is monopolar or bipolar.

4. The method of claim 2, wherein the electrosurgical unit operates at a frequency between about 350 KHz and about 4 MHz.

5. The method of claim 1, wherein the hydrophilic polymer membrane accelerates reformation of a boundary layer comprising charged species about the flux-limiting layer of the electrochemical biosensor during in vivo use thereof in a subject.

6. The method of claim 1, wherein the hydrophilic polymer membrane is covalently or ionically coupled to the flux-limiting layer.

7. The method of claim 1, wherein the hydrophilic polymer membrane 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, polyvinyl alcohol, polyethylene glycol, polyvinyl acetate, polyelectrolyte, and copolymers thereof.

8. The method of claim 1, wherein the hydrophilic polymer membrane is essentially water-insoluble.

9. The method of claim 1, wherein the flux-limiting membrane is selected from the group consisting of vinyl polymers, polysilicones, polyurethanes, and copolymers or blends thereof.

10. The method of claim 9, wherein the flux-limiting membrane is polyethylene vinylacetate.

11. The method of claim 1, the electrochemical sensor further comprising at least one of:

a hydrophilic layer at least partially covering the electrode surface;

or

an interference layer at least partially covering the electrode surface;

or

an enzyme layer at least partially covering an interference layer.

12. The method of claim 11, wherein the interference layer comprises a cellulosic derivative or cellulose acetate butyrate, or wherein the enzyme layer 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, polyvinyl alcohol, polyethylene glycol, polyelectrolyte and copolymers thereof.

13. The method of claim 11, wherein the enzyme layer comprises glucose oxidase, poly-N-vinylpyrrolidone, and optionally an amount of crosslinking agent sufficient to immobilize the glucose oxidase.

14. An electrochemical analyte sensor, comprising:

an in vivo biosensor capable of sensing an analyte level in blood and outputting a signal corresponding to the analyte concentration, the in vivo biosensor comprising;

an electrode surface;

an enzyme layer covering at least a portion of the electrode surface;

a flux-limiting layer covering at least a portion of the enzyme layer and at least a portion of the electrode surface; and

a hydrophilic polymer membrane covering at least a portion of the flux-limiting layer;

wherein disruption of the output signal of the analyte sensor, when operated in the presence of an external EMF or external RF source during in vivo use is reduced.

15. The electrochemical analyte sensor of claim 14, wherein the hydrophilic polymer membrane accelerates reformation of a boundary layer comprising charged species about the flux-limiting layer of the electrochemical biosensor during in vivo use thereof in a subject.

16. The electrochemical analyte sensor of claim 14, wherein the hydrophilic polymer membrane 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, polyvinyl alcohol, polyethylene glycol, polyvinyl acetate, polyelectrolyte, and copolymers thereof.

17. The electrochemical analyte sensor of claim 14, wherein the hydrophilic polymer membrane is covalently or ionically coupled to the flux-limiting layer.

18. The electrochemical analyte sensor of claim 14, wherein the hydrophilic polymer membrane is essentially water-insoluble.

19. The electrochemical analyte sensor of claim 14, wherein the flux-limiting membrane is selected from the group consisting of vinyl polymers, polysilicones, polyurethanes, and copolymers or blends thereof.

20. The electrochemical analyte sensor of claim 14, wherein the flux-limiting membrane is poly(ethylene-vinylacetate).

21. The electrochemical analyte sensor of claim 14, further comprising at least one of:

a hydrophilic layer at least partially covering the electrode surface;

or

an interference layer at least partially covering the electrode surface;

or

an enzyme layer at least partially covering an interference layer.

22. The electrochemical analyte sensor of claim 21, wherein the interference layer comprises a cellulosic derivative or cellulose acetate butyrate, or wherein the enzyme layer 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, polyvinyl alcohol, polyethylene glycol, polyelectrolyte, and copolymers thereof.

23. The electrochemical analyte sensor of claim 21, wherein the enzyme layer comprises glucose oxidase, poly-N-vinylpyrrolidone, and optionally an amount of crosslinking agent sufficient to immobilize the glucose oxidase.

24. A method comprising:

providing an in vivo electrochemical biosensor, the biosensor comprising;

an electrode surface;

a hydrophilic layer covering at least a portion of the electrode surface;

an interference layer covering at least a part of the hydrophilic layer;

an enzyme layer covering at least a part of the interference layer;

a flux-limiting layer covering at least a portion of the enzyme layer;

covering at least a portion of the flux-limiting layer with a hydrophilic polymer membrane, wherein the hydrophilic polymer membrane comprises a material selected from the group consisting of poly-N-vinylpyrrolidone, polyacrylamide, polyvinyl acetate, and polyelectrolyte; and

reducing disruption of the output signal of the electrochemical biosensor by an electrosurgical unit (ESU) during in vivo use of the biosensor in a subject.

25. The method of claim 24, wherein the flux-limiting membrane is polyethylene vinylacetate.