Cationic polymer based wired enzyme formulations for use in analyte sensors

• US 9,428,785 B2
• Filed: 12/02/2014
• Issued: 08/30/2016
• Est. Priority Date: 09/15/2008
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Feldman, Benjamin J., Ouyang, Tianmei, Liu, Zenghe
• Primary Examiner(s): LEONG, SUSAN DANG
• Application Number:
  US14/558,509
• Publication Number:
  US 20150090590A1
• Time in Patent Office: 637 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/005 involving specific analytes or enzymes including groups of enzymes, e.g. oxydases; C12Q1/004 takes precedence
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: C12Q 1/32 involving dehydrogenase
• CPC Class Codes: G01N 2333/904 acting on CHOH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875

Abstract

Embodiments of the invention include analyte-responsive compositions and electrochemical analyte sensors having a sensing layer that includes an analyte-responsive enzyme and a cationic polymer. Also provided are systems and methods of making the sensors and using the electrochemical analyte sensors in analyte monitoring.

Claims

1. An analyte sensor assembly, comprising:

an electrochemical sensor comprising;

a substrate comprising a working electrode and a counter electrode or a counter/reference electrode;

a sensing layer disposed on the working electrode, wherein the sensing layer comprises a glucose-responsive enzyme, a cationic polymer selected from the group consisting of polyallylamine (PAH), polyethyleneimine (PEI), poly(L-lysine) (PLL), or poly(L-arginine) (PLA), and a positively charged redox mediator non-covalently associated with the cationic polymer; and

a transmitter unit operatively coupled to the electrochemical sensor to receive signals from the electrochemical sensor corresponding to an analyte level of a subject.

2. The analyte sensor of claim 1, wherein at least a portion of the sensor is adapted to be subcutaneously positioned in a subject.

3. The analyte sensor of claim 1, wherein the analyte-responsive enzyme is glucose oxidase (GOx).

4. The analyte sensor of claim 1, wherein the analyte-responsive enzyme is a dehydrogenase.

5. The analyte sensor of claim 4, wherein the dehydrogenase is glucose dehydrogenase (GDH).

6. The analyte sensor of claim 5, wherein the glucose dehydrogenase is associated with a co-factor.

7. The analyte sensor of claim 6, wherein the co-factor is flavin adenine dinucleotide (FAD), nicotinamide adenine dinucleotide (NAD), or pyrroloquinoline quinone (PQQ).

8. The analyte sensor of claim 4, wherein the dehydrogenase comprises a complex of glucose dehydrogenase (GDH) and flavin adenine dinucleotide (FAD).

9. The analyte sensor of claim 1, further comprising a flux limiting layer disposed over at least a portion of the working electrode.

10. The analyte sensor of claim 1, wherein the redox mediator comprises ferricyanide, phenanthroline quinone, or ferrocene.

11. The analyte sensor of claim 1, wherein the redox mediator comprises a transition metal complex.

12. The analyte sensor of claim 11, wherein the transition metal complex comprises osmium.

13. The analyte sensor of claim 1, wherein the transition metal complex comprises the following formula:

14. The analyte sensor of claim 13, wherein the transition metal complex comprises the following formula:

15. The analyte sensor of claim 14, wherein at least one of R₁, R₂, and R′

₁ comprises a reactive group selected from the group consisting of carboxy, activated ester, sulfonyl halide, sulfonate ester, isocyanate, isothiocyanate, epoxide, aziridine, halide, aldehyde, ketone, amine, acrylamide, thiol, acyl azide, acyl halide, hydrazine, hydroxyamine, alkyl halide, imidazole, pyridine, phenol, alkyl sulfonate, halotriazine, imido ester, maleimide, hydrazide, hydroxy, and photo-reactive azido aryl groups.