Cationic polymer based wired enzyme formulations for use in analyte sensors

• US 8,636,884 B2
• Filed: 09/15/2008
• Issued: 01/28/2014
• 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:
  US12/211,014
• Publication Number:
  US 20100065441A1
• Time in Patent Office: 1,961 Days
• Field of Search: 600/345, 600/347, 600/346, 600/348, 600/373, 600/395, 205775-7945, 20440301-40315
• US Class Current: 204/403.12
• 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 implantable electrode comprising:

a conductive layer disposed on a substrate; and

a glucose-responsive composition disposed on the conductive layer, the glucose-responsive composition comprising;

a glucose-responsive enzyme and a positively charged redox mediator to accept electrons from the enzyme incorporated into a cationic polymer selected from the group consisting of polyallylamine (PAH), polyethyleneimine (PEI), poly(L-lysine) (PLL), or poly(L -arginine) (PLA), wherein the positively charged redox mediator is non-covalently associated with the cationic polymer; and

a mass transport-limiting layer disposed on top of the glucose-responsive composition.

2. The electrode of claim 1, wherein the glucose-responsive enzyme is glucose oxidase (GOx).

3. The electrode of claim 1, wherein the glucose-responsive enzyme is glucose dehydrogenase (GDH).

4. The electrode of claim 3, wherein the glucose dehydrogenase is associated with a co-factor.

5. The electrode of claim 3, wherein the co-factor is flavin adenine dinucleotide (FAD), nicotinamide adenine dinucleotide (NAD), or pyrroloquinoline quinone (PQQ).

6. The electrode of claim 1, wherein the glucose-responsive enzyme comprises a complex of glucose dehydrogenase (GDH) and flavin adenine dinucleotide (FAD).

7. The electrode of claim 1, wherein the redox mediator comprises a transition metal complex.

8. The electrode of claim 7, wherein the transition metal complex comprises osmium.

9. The electrode of claim 7, wherein the transition metal complex comprises the following formula:

10. The electrode of claim 9, wherein the transition metal complex comprises the following formula:

11. The electrode of claim 10, 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.