Biosensor membranes

• US 9,014,774 B2
• Filed: 04/12/2013
• Issued: 04/21/2015
• Est. Priority Date: 05/15/2001
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Mao, Fei, Cho, Hyun
• Primary Examiner(s): D'Angelo, Michael
• Assistant Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US13/862,157
• Publication Number:
  US 20130296676A1
• Time in Patent Office: 739 Days
• Field of Search: 600/345, 600/347, 600/365
• US Class Current: 600/347
• 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 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• 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 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: C12Q 1/002 Electrode membranes
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

Novel membranes comprising various polymers containing heterocyclic nitrogen groups are described. These membranes are usefully employed in electrochemical sensors, such as amperometric biosensors. More particularly, these membranes effectively regulate a flux of analyte to a measurement electrode in an electrochemical sensor, thereby improving the functioning of the electrochemical sensor over a significant range of analyte concentrations. Electrochemical sensors equipped with such membranes are also described.

Claims

1. An electrochemical sensor comprising:

a substrate comprising a first face and a second face opposite the first face;

a first electrode positioned on the first face of the substrate, the first electrode comprising a sensing layer disposed thereon;

a second electrode positioned on the second face of the substrate; and

a flux-limiting membrane comprising;

a poly(4-vinylpyridine-co-styrene) polymer; and

a poly(ethylene glycol)-containing constituent.

2. The electrochemical sensor according to claim 1, wherein the electrochemical sensor is configured to provide a sensor signal that is insensitive to motion.

3. The electrochemical sensor according to claim 1, wherein the electrochemical sensor is configured to provide a sensor signal that is insensitive to motion for 3 continuous minutes or more.

4. The electrochemical sensor according to claim 3, wherein the electrochemical sensor is configured to provide a sensor signal that is insensitive to motion at a glucose concentration of 10 mM or greater.

5. The electrochemical sensor according to claim 3, wherein the electrochemical sensor is configured to provide a sensor signal that is insensitive to motion at a glucose concentration from 0 mM to 15 mM.

6. The electrochemical sensor according to claim 1, wherein the electrochemical sensor is configured to provide a sensor signal that is linear at a glucose concentration of greater than 10 mM.

7. The electrochemical sensor according to claim 1, wherein the electrochemical sensor is configured to provide a sensor signal that is linear at a glucose concentration from 0 nM to 30 nM.

8. The electrochemical sensor according to claim 1, wherein the electrochemical sensor is configured to provide a sensor signal having a sensitivity which decays at a rate of 0.05% nA per hour or less.

9. The electrochemical sensor according to claim 8, wherein the electrochemical sensor is configured to provide a sensor signal having a sensitivity which decays at a rate of 0.05% nA per hour or less when measured in a glucose concentration of 30 mM for 20 hours or longer.

10. The electrochemical sensor according to claim 1, wherein the electrochemical sensor is configured to have a glucose sensitivity of from 1.0 nA/mM to 1.5 nA/mM.

11. The electrochemical sensor of claim 1, wherein the poly(ethylene glycol)-containing constituent is a copolymer of polyethylene glycol and polypropylene glycol.

12. The electrochemical sensor of claim 1, wherein the poly(ethylene glycol)-containing constituent is a polyetheramine.

13. An electrochemical sensor, comprising:

a substrate comprising a first face and a second face opposite the first face;

a first electrode positioned on the first face of the substrate, the first electrode comprising a sensing layer disposed thereon;

a second electrode positioned on the second face of the substrate; and

a flux-limiting membrane comprising;

a poly(4-vinylpyridine-co-styrene) polymer; and

a poly(ethylene glycol)-containing constituent,

wherein the electrochemical sensor is configured to provide a sensor signal that is insensitive to motion and is linear at a concentration from 0 nM to 30 nM.

14. The electrochemical sensor according to claim 13, wherein the electrochemical sensor is configured to have a glucose sensitivity of 1.0 nA/mM to 1.5 nA/mM.

15. An electrochemical sensor, comprising:

a substrate comprising a first face and a second face opposite the first face;

a first electrode positioned on the first face of the substrate, the first electrode comprising a sensing layer disposed thereon;

a second electrode positioned on the second face of the substrate; and

a flux-limiting membrane comprising;

a poly(4-vinylpyridine-co-styrene) polymer; and

a poly(ethylene glycol)-containing constituent,

wherein the electrochemical sensor is configured to provide a sensor signal that is insensitive to motion and to have a glucose sensitivity of 1.0 nA/mM to 1.5 nA/mM.

16. The electrochemical sensor according to claim 15, wherein the electrochemical sensor is configured to provide a sensor signal that is insensitive to motion at a glucose concentration from 0 mM to 15 mM.