IP Library Granted Patent US 12686881
Granted Patent B2
US 12686881 · App. 19/320,168 · Granted Jul 21, 2026

NAD(P)-dependent responsive enzymes, electrodes and sensors, and methods for making and using the same

Inventors: Tianmei Ouyang (Saratoga, CA); Benjamin J. Feldman (Berkeley, CA)
Assignee: ABBOTT DIABETES CARE INC.
C12Q1/001A61B5/14865C12N11/082C12Q1/004C12Q1/005C12Q1/006C12Q1/26G01N27/3275G01N33/5735G01N33/66C12Y106/05002G01N27/27
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Quick Facts
Patent No.
US 12686881
App. No.
19/320,168
Granted
Jul 21, 2026
Kind
B2
Abstract

NADP-dependent oxidoreductase compositions, and electrodes, sensors and systems that include the same. Analyte sensors include an electrode having a sensing layer disposed thereon, the sensing layer comprising a polymer and an enzyme composition distributed therein. The enzyme composition includes nicotinamide adenine dinucleotide phosphate (NAD(P) + ) or derivative thereof, an NAD(P) + -dependent dehydrogenase; an NAD(P)H oxidoreductase; and an electron transfer agent comprising a transition metal complex.

Claims (26)

1 . A sensor for detecting D-3-hydroxybutyrate in vivo, the sensor comprising:

a first portion configured to be positioned above a user's skin; and

a second portion configured to be transcutaneously positioned in the user's skin and in contact with the user's interstitial fluid to monitor the level of D-3-hydroxybutyrate in vivo, the second portion comprising:

i) a working electrode having an enzyme composition disposed thereon, the enzyme composition comprising:

a) nicotinamide adenine dinucleotide (phosphate) (NAD(P)+) or derivative thereof;

b) D-3-hydroxybutyrate dehydrogenase;

c) diaphorase;

d) an electron transfer agent;

e) a polymer,

wherein the NAD(P)+ or derivative thereof is not covalently bonded to the polymer; and

ii) a mass transport limiting membrane disposed over the enzyme composition,

wherein the working electrode is configured to generate a signal associated with the level of D-3-hydroxybutyrate,

wherein the mass transport limiting membrane limits flux of D-3-hydroxybutyrate to the working electrode, and

wherein the signal associated with the level of D-3-hydroxybutyrate increases linearly as a function of D-3-hydroxybutyrate concentration over a range of 0 mM to 10 mM.

2 . The analyte sensor of claim 1 , wherein the D-3-hydroxybutyrate dehydrogenase is covalently bonded to the polymer.

3 . The analyte sensor of claim 2 , wherein the diaphorase is covalently bonded to the polymer.

4 . The analyte sensor of claim 3 , wherein the electron transfer agent is covalently bonded to the polymer.

5 . The analyte sensor of claim 1 , wherein enzyme composition further comprises a crosslinker for immobilizing the enzyme composition onto a surface of the working electrode.

6 . The analyte sensor of claim 1 , wherein the mass transport limiting membrane comprises crosslinked polymers.

7 . The analyte sensor of claim 6 , wherein the polymers contain heterocyclic nitrogen groups.

8 . The analyte sensor of claim 6 , wherein the polymers comprise polyvinylpyridine.

9 . The analyte sensor of claim 6 , wherein the polymers comprise poly(4-vinylpyridine-co-styrene).

10 . The analyte sensor of claim 7 , wherein the mass transport limiting membrane further comprises a hydrophilic or hydrophobic modifier.

11 . The analyte sensor of claim 1 , wherein the mass transport limiting membrane is a polyurethane or polyether urethane membrane.

12 . The analyte sensor of claim 1 , wherein the signal and D-3-hydroxybutyrate concentration exhibit an R 2 value of at least 0.99 over a range of 0 mM to 10 mM.

13 . The analyte sensor of claim 1 , wherein the signal decays no more than 8% when exposed to a given D-3-hydroxybutyrate concentration for 45 hours.