Granted Patent B2

US 12,398,413 · App. 17/819,038 · Granted Aug 26, 2025

Inventors: Tianmei Ouyang (Fremont, CA); Benjamin J. Feldman (Berkeley, CA)

Assignee: ABBOTT DIABETES CARE INC.

C12Q1/001A61B5/14865C12N11/082C12Q1/004C12Q1/005C12Q1/006C12Q1/26G01N27/3275G01N33/5735G01N33/66C12Y106/05002G01N27/27

Abstract

Claims (35)

1. An electrochemical analyte 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 biological fluid to monitor the level of an analyte in vivo, the second portion comprising:

i) an electrode;

ii) an enzyme composition disposed upon the electrode, the enzyme composition comprising:

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

b) D-3-hydroxybutyrate dehydrogenase;

c) an NAD(P)H oxidoreductase;

d) a polymeric redox mediator, and

iii) a membrane disposed on the enzyme composition,

wherein the sensor produces a signal that increases linearly as a function of D-3-hydroxybutyrate concentration from 0 mM to 10 mM.

2. The analyte sensor of claim 1 , wherein the signal increases linearly as a function of D-3-hydroxybutyrate concentration from 0 μM to 240 μM.

3. The analyte sensor of claim 2 , wherein the signal that increases linearly has a slope of about 0.016 nA/μM.

4. The analyte sensor of claim 1 , wherein the signal that increases linearly has a slope of about 2.5 nA/mM.

5. The analyte sensor of claim 1 , wherein the signal that increases linearly has a R 2 value of at least 0.99.

6. 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.

7. The analyte sensor of claim 1 , wherein the NAD(P)H oxidoreductase is diaphorase.

8. An electrochemical analyte 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 biological fluid to monitor the level of an analyte in vivo, the second portion comprising:

i) an electrode;

ii) an enzyme composition disposed upon the electrode, the enzyme composition comprising:

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

b) D-3-hydroxybutyrate dehydrogenase;

c) an NAD(P)H oxidoreductase;

d) a polymeric redox mediator, and

iii) a membrane disposed on the enzyme composition,

wherein the sensor produces a signal based on analyte concentration that decays no more than 8% when exposed to a given D-3-hydroxybutyrate concentration for 45 hours.

9. The analyte sensor of claim 8 , wherein the signal increases linearly as a function of D-3-hydroxybutyrate concentration.

10. The analyte sensor of claim 9 , wherein the signal increases linearly as a function of D-3-hydroxybutyrate concentration from 0 mM to 10 mM.

11. The analyte sensor of claim 9 , wherein the signal increases linearly as a function of D-3-hydroxybutyrate concentration from 0 μM to 240 μM.

12. The analyte sensor of claim 11 , wherein the signal that increases linearly has a slope of about 0.016 nA/μM.

13. The analyte sensor of claim 10 , wherein the signal that increases linearly has a slope of about 2.5 nA/mM.

14. The analyte sensor of claim 9 , wherein the signal that increases linearly has a R 2 value of at least 0.99.

15. The analyte sensor of claim 8 , wherein the NAD(P)H oxidoreductase is diaphorase.

Assignments (1)

Continuity (4)

References Cited (283)