Analyte sensors having temperature independent membranes

• US 10,022,076 B2
• Filed: 05/26/2017
• Issued: 07/17/2018
• Est. Priority Date: 07/28/2010
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hoss, Udo, Feldman, Benjamin J., Ouyang, Tianmei
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): MESSERSMITH, ERIC J
• Application Number:
  US15/607,099
• Publication Number:
  US 20170258377A1
• Time in Patent Office: 417 Days
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: C12Q 1/002 Electrode membranes

Abstract

Embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have a membrane structure with an analyte permeability that is substantially temperature independent. The devices also include a sensing layer disposed on a working electrode of in vivo analyte sensors, e.g., continuous and/or automatic in vivo monitoring using analyte sensors and/or test strips. Also provided are systems and methods of using the, for example electrochemical, analyte sensors in analyte monitoring.

Claims

1. A method of fabricating an electrode for use in an analyte sensor, the method comprising:

contacting an electrode with a sensing layer; and

either

contacting the sensing layer with a first membrane having a negative temperature coefficient, and then contacting the first membrane with a second membrane having a positive temperature coefficient, or

contacting the sensing layer with a second membrane having a positive temperature coefficient, and then contacting the second membrane with a first membrane having a negative temperature coefficient,

thereby forming a stacked membrane structure, wherein the stacked membrane structure has an analyte permeability that is substantially temperature independent.

2. The method of claim 1, wherein the analyte sensor generates signals that are substantially temperature independent over a range of temperatures.

3. The method of claim 2, wherein the range of temperatures is from 25°

C. to 45°

C.

4. The method of claim 2, wherein the analyte sensor generates signals that are within 90% or more of each other over the range of temperatures at a constant analyte concentration.

5. The method of claim 2, wherein the analyte sensor generates signals that are within 95% or more of each other over the range of temperatures at a constant analyte concentration.

6. The method of claim 1, wherein the stacked membrane structure is configured to have a total temperature coefficient that is substantially zero.

7. The method of claim 1, wherein the first membrane is configured to have an analyte permeability that varies inversely with temperature, and the second membrane is configured to have an analyte permeability that varies directly with temperature.

8. The method of claim 1, wherein the first membrane comprises:

poly(styrene-co-maleic anhydride), dodecylamine, and poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol) (2-aminopropyl ether) crosslinked with poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol) bis(2-aminopropyl ether);

poly(n-isopropyl acrylamide);

or a copolymer of poly(ethylene oxide) and poly(propylene oxide).

9. The method of claim 1, wherein the second membrane comprises:

polyvinylpyridine, a derivative of polyvinylpyridine, polyvinylimidazole, a derivative of polyvinylimidazole, or a combination thereof.

10. The method of claim 1, wherein the first and second membranes are chemically bound to each other.

11. The method of claim 1, wherein the first and second membranes are laminated to each other.

12. The method of claim 1, wherein the first and second membranes are crosslinked to each other.

13. The method of claim 1, wherein the stacked membrane structure is chemically bound to the sensing layer.

14. The method of claim 1, wherein the stacked membrane structure is laminated to the sensing layer.

15. The method of claim 1, wherein the stacked membrane structure is crosslinked to the sensing layer.

16. The method of claim 1, wherein the stacked membrane structure is configured to be a diffusion-limiting membrane structure.

17. The method of claim 1, wherein the stacked membrane structure is configured to be a size-exclusion membrane structure.

18. The method of claim 1, wherein the sensing layer comprises an analyte-responsive enzyme and a redox mediator.

19. The method of claim 18, wherein at least one of the analyte-responsive enzyme and the redox mediator is chemically bound to a polymer.

20. The method of claim 18, wherein at least one of the analyte-responsive enzyme and the redox mediator is crosslinked to a polymer.

21. The method of claim 18, wherein the redox mediator comprises a ruthenium-containing complex or an osmium-containing complex.

22. The method of claim 18, wherein the analyte sensor is a glucose sensor.