IP Library › Granted Patent US 12,672,803
Granted Patent B2
US 12,672,803 · App. 19/340,421 · Granted Jul 7, 2026

Analyte sensors employing multiple enzymes and methods associated therewith

Inventors: Stephen Oja (Reno, NV); Tianmei Ouyang (Saratoga, CA); Hyun Cho (Berkeley, CA); Lam N. Tran (Danville, CA); Benjamin J. Feldman (Berkeley, CA)
Assignee: Abbott Diabetes Care Inc.
A61B5/14865A61B5/14532C12Q1/002G01N27/3271C12Q1/005G01N2333/9029G01N2333/904G01N2333/908
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Quick Facts
Patent No.
US 12,672,803
App. No.
19/340,421
Filed
Sep 25, 2025
Granted
Jul 7, 2026
Kind
B2
Examiner
BALL, JOHN C
Art Unit
1795
USPC
600/345
Abstract

Methods and analyte sensors including at least a first working electrode having a first active area thereon, and performing a dip coating operation to deposit a bilayer membrane upon the first working electrode and the first active area. The bilayer may include an inner layer having a first membrane polymer and an outer layer having a second membrane polymer, the first membrane polymer and the second membrane polymer differing from one another. The dip coating operation may comprise one or more first dips in a first membrane formulation to form the inner layer of the bilayer membrane and one or more second dips in a second membrane formulation to form the outer layer of the bilayer membrane upon the inner layer.

Claims (39)

1 . A sensor control device for detecting glucose and ketones in vivo, the sensor control device comprising:

(a) a sensor comprising:

a substrate with a first face and a second face;

a reference electrode;

a first working electrode, wherein a ketones-responsive active area is disposed upon a surface of the first working electrode;

a second working electrode, wherein a glucose-responsive active area is disposed upon a surface of the second working electrode, wherein the electrodes are electrically isolated from one another by a dielectric material; and

a mass transport limiting membrane overcoating the ketones-responsive active area and the glucose-responsive active area, the mass transport limiting membrane providing variable analyte permeability at each of the ketones-responsive active area and the glucose-responsive active area;

wherein the mass transport limiting membrane overcoating at least the ketones-responsive active area comprises a multi-component membrane; and

wherein the sensor is configured to be partially inserted into a user's skin such that a distal portion of the sensor is in contact with an interstitial fluid to detect glucose and ketones in vivo; and

(b) sensor electronics.

2 . The sensor control device of claim 1 , wherein the first and second working electrodes are independently disposed on the first and second faces of the substrate.

3 . The sensor control device of claim 1 , wherein the first working electrode and the second working electrode are located on opposite faces of the substrate, and wherein the ketones-responsive active area and the glucose-responsive active area are laterally spaced apart.

4 . The sensor control device of claim 1 , wherein the first working electrode and the second working electrode are each located on the first face or the second face of the substrate, and wherein the ketones-responsive active area and the glucose-responsive active area are vertically spaced apart.

5 . The sensor control device of claim 3 , further comprising a counter electrode.

6 . The sensor control device of claim 5 , wherein the reference electrode and the counter electrode are located on opposite faces of the substrate.

7 . The sensor control device of claim 4 , further comprising a counter electrode.

8 . The sensor control device of claim 7 , wherein the reference electrode and the counter electrode are each located on the first or second face of the substrate.

9 . The sensor control device of claim 1 , wherein the ketones-responsive active area comprises a first polymer and an enzyme system comprising nicotinamide adenine dinucleotide (NAD) and at least two enzymes that facilitate detection of ketones.

10 . The sensor control device of claim 9 , wherein the glucose-responsive active area comprises a second polymer and a glucose-responsive enzyme.

11 . The sensor control device of claim 1 , wherein the multi-component membrane disposed upon the ketone-responsive active area comprises two or more different membrane polymers.

12 . The sensor control device of claim 11 , wherein the multi-component membrane disposed upon the ketone-responsive active area comprises at least a bilayer membrane.

13 . The sensor control device of claim 11 , wherein the mass transport limiting membrane has a thickness over the ketones-responsive active area that differs from a thickness of the mass transport limiting membrane over the glucose-responsive active area.

14 . The sensor control device of claim 11 , wherein the mass transport limiting membrane has a composition over the ketones-responsive active area that differs from a composition of the mass transport limiting membrane over the glucose-responsive active area.

15 . The sensor control device of claim 14 , wherein:

the mass transport limiting membrane comprises a first portion overcoating the ketones-responsive active area and a second portion overcoating the glucose-responsive active area; wherein

the first portion comprises a first membrane polymer and a second membrane polymer that differ from each other; and wherein

the second portion comprises the first membrane polymer or the second membrane polymer.

16 . The sensor control device of claim 15 , wherein the first membrane polymer comprises a crosslinked polyvinylpyridine homopolymer or copolymer.

17 . The sensor control device of claim 16 , wherein the second membrane polymer comprises a crosslinked polyvinylpyridine-co-styrene polymer.

18 . The sensor control device of claim 14 , wherein the ketones-responsive and glucose-responsive active areas each comprises at least one sensing spot, and the ketones-responsive and glucose-responsive active areas each range in size from about 0.01 mm 2 to about 1 mm 2 .

19 . The sensor control device of claim 9 , wherein the enzyme system comprises β-hydroxybutyrate dehydrogenase and diaphorase.

20 . The sensor control device of claim 10 , wherein the glucose-responsive enzyme comprises glucose oxidase.

21 . The sensor control device of claim 9 , wherein the ketones-responsive active area comprises a first electron transfer agent.

22 . The sensor control device of claim 10 , wherein the glucose-responsive active area comprises a second electron transfer agent.

23 . The sensor control device of claim 1 , wherein the first working electrode is configured to independently generate a first signal indicative of β-hydroxybutyrate concentration, and wherein the second working electrode is configured to independently generate a second signal indicative of glucose concentration.

24 . The sensor control device of claim 23 , wherein the first signal and second signal are measured simultaneously via a first channel and a second channel, respectively.

25 . The sensor control device of claim 23 , wherein the sensor electronics are configured to determine a ketone concentration and glucose concentration based on the first and second signals using a calibration curve for each analyte.

26 . An analyte sensing system for detecting glucose and ketones in vivo comprising the sensor control device of claim 1 .

27 . The analyte sensing system of claim 26 , further comprising a reader device.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 26, 2025
From: OJA, STEPHEN; OUYANG, TIANMEI; CHO, HYUN; TRAN, LAM N.; FELDMAN, BENJAMIN J.
To: ABBOTT DIABETES CARE INC.
Reel/Frame 073046/0462 →
Continuity (6)
Continuation 18910782 · Oct 9, 2024
Continuation 17819099 · Aug 11, 2022
Continuation 17151274 · Jan 18, 2021
Continuation 16774841 · Jan 28, 2020
Provisional Application 62797566 · Jan 28, 2019
Related Publication 20260020797A1 · Jan 22, 2026
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