Granted Patent B2

US 12,672,804 · App. 19/340,445 · Granted Jul 7, 2026

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

Abstract

Claims (35)

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 comprising:

a first membrane disposed over the ketones-responsive active area; and

a second membrane disposed over the first membrane and the glucose-responsive active area,

wherein the first and second membranes have different permeability values providing variable analyte permeability at the ketones-responsive active area and the glucose-responsive active area; 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 electrodes are independently disposed on the first and the 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 3 , further comprising a counter electrode.

5 . The sensor control device of claim 4 , wherein the reference electrode and the counter electrode are located on opposite faces of the substrate.

6 . 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.

7 . The sensor control device of claim 6 , 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 enzyme system comprises β-hydroxybutyrate dehydrogenase and diaphorase.

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

12 . The sensor control device of claim 1 , wherein the first membrane comprises a first membrane polymer and the second membrane comprises a second membrane polymer that differs from the first membrane polymer.

13 . The sensor control device of claim 12 , wherein the first membrane polymer comprises a crosslinked polyvinylpyridine homopolymer or copolymer.

14 . The sensor control device of claim 13 , wherein the second membrane polymer comprises a crosslinked polyvinylpyridine-co-styrene polymer.

15 . The sensor control device of claim 12 , wherein the enzyme comprises glucose oxidase.

16 . The sensor control device of claim 12 , wherein the glucose-responsive active area comprises a second electron transfer agent.

17 . The sensor control device of claim 1 , 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 .

18 . 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.

19 . The sensor control device of claim 18 , wherein the first signal and second signal are measured simultaneously via a first channel and a second channel, respectively.

20 . The sensor control device of claim 18 , 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.

21 . An analyte sensing system for detecting glucose and ketones in vivo comprising the sensor control device of claim 20 .

22 . The analyte sensing system of claim 21 , further comprising a reader device to display the ketone concentration and glucose concentration.

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

24 . The analyte sensing system of claim 23 , further comprising a reader device.

Assignments (1)

Continuity (6)

References Cited (328)