MEMBRANE LAYERS FOR ANALYTE SENSORS

• US 20170188916A1
• Filed: 12/30/2016
• Published: 07/06/2017
• Est. Priority Date: 12/30/2015
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Zhang, Huashi, Wang, Shanger, Lee, Ted Tang, Sze, David, Tapsak, Mark A, Dennis, Andrew Trinin, Suri, Jeff T., Boock, Robert J., Zou, Jiong
• Granted Patent: US 11,262,326 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• 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 5/1486 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: A61K 31/045 Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/46 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
• CPC Class Codes: A61K 31/465 Nicotine; Derivatives thereof
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/515 Barbituric acids; Derivatives thereof, e.g. sodium pentobarbital
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 36/185 Magnoliopsida (dicotyledons)
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: C08G 18/0828 containing sulfonate groups or groups forming them
• CPC Class Codes: C08G 18/12 using two or more compounds having active hydrogen in the first polymerisation step
• CPC Class Codes: C08G 18/3234 : cycloaliphatic
• CPC Class Codes: C08G 18/3857 : having nitrogen in addition to sulfur
• CPC Class Codes: C08G 18/4018 : Mixtures of compounds of group C08G18/42 with compounds of group C08G18/48
• CPC Class Codes: C08G 18/44 : Polycarbonates
• CPC Class Codes: C08G 18/4833 : Polyethers containing oxyethylene units
• CPC Class Codes: C08G 18/755 : and at least one isocyanate or isothiocyanate group linked to a secondary carbon atom of the cycloaliphatic ring, e.g. isophorone diisocyanate
• CPC Class Codes: C08L 39/06 : Homopolymers or copolymers of N-vinyl-pyrrolidones
• CPC Class Codes: C08L 69/00 : Compositions of polycarbonates; Compositions of derivatives of polycarbonates
• CPC Class Codes: C08L 75/04 : Polyurethanes
• CPC Class Codes: C12N 11/08 : the carrier being a synthetic polymer
• CPC Class Codes: C12N 11/089 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: C12N 11/093 : Polyurethanes
• CPC Class Codes: C12Q 1/002 : Electrode membranes
• CPC Class Codes: C12Q 1/006 : for glucose
• CPC Class Codes: G01N 27/3273 : Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/3275 : Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction
• CPC Class Codes: G01N 33/66 : involving blood sugars, e.g. galactose

Abstract

Disclosed are devices for determining an analyte concentration (e.g., glucose). The devices comprise a sensor configured to generate a signal associated with a concentration of an analyte and a sensing membrane located over the sensor. The sensing membrane comprises a biointerface layer which interfaces with a biological fluid containing the analyte to be measured. The biointerface layer can comprises a biointerface polymer, wherein the biointerface polymer comprises polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The sensing membrane can also comprise an enzyme layer, wherein the enzyme layer comprises an enzyme and a polymer comprising polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The sensing membrane can also comprise a diffusion-resistance layer, which can comprise a base polymer having a lowest Tg of greater than −50 C.

Claims

1. A device for monitoring an analyte concentration, the device comprising:

a transcutaneous sensor configured to generate a signal associated with a concentration of an analyte; and

a sensing membrane located over the sensor, the sensing membrane comprising a diffusion-resistance layer comprising a base polymer having a lowest glass transition temperature as measured using ASTM D3418 of greater than −

50°

C.

2. The device of claim 1, wherein the lowest glass transition temperature of the base polymer is greater than 0°

C.

3. The device of claim 1, wherein the lowest glass transition temperature of the base polymer is from 0°

C. to 66°

C.

4. The device of claim 1, wherein the lowest glass transition temperature of the base polymer is from 20°

C. to 60°

C.

5. The device of claim 1, wherein the lowest glass transition temperature of the base polymer is from 0°

C. to 30°

C.

6. The device of claim 1, wherein the lowest glass transition temperature of the base polymer is from 30°

C. to 60°

C.

7. The device of claim 1, wherein the ultimate tensile strength of the base polymer is greater than 8250 psi.

8. The device of claim 1, wherein the base polymer is a segmented block copolymer.

9. The device of claim 1, wherein the base polymer comprises polyurethane and/or polyurea segments and one or more polycarbonate or polyester segments.

10. The device of claim 1, wherein the base polymer is a polyurethane copolymer chosen from a polycarbonate-urethane, polyether-urethane, and polyester-urethane.

11. The device of claim 1, wherein the base polymer comprises a polymer selected from epoxies, polystylene, polyoxymethylene, polysiloxanes, polyethers, polyacrylics, polymethacrylic, polyesters, polycarbonates, polyamide, poly(ether ketone), and poly(ether imide).

12. The device of claim 1, wherein the base polymer is substantially free of silicone.

13. The device of claim 1, wherein the diffusion-resistance layer further comprises a hydrophilic polymer.

14. The device of claim 13, wherein the hydrophilic polymer is selected from polyvinyl alcohol, polyethylene glycol, polyacrylamide, polyacetate, polyethylene oxide, polyethyleneamine, polyvinylpyrrolidone, polyoxzazloine, and mixtures thereof.

15. The device of claim 13, wherein the hydrophilic polymer is blended with the base polymer.

16. The device of claim 13, wherein the hydrophilic polymer is covalently bonded to the base polymer.

17. The device of claim 13, wherein the base polymer or hydrophilic polymer comprise a crosslinker or several crosslinkers, where in the crosslinker comprise a polymer or oligomer selected from polyfunctional isocynate, polyfunctional aziridine, polyfunctional carbodiimide.

18. The device of claim 1, wherein the diffusion-resistance layer comprises a blend of a polycarbonate-urethane base polymer and polyvinylpyrrolidone.

19. The device of claim 1, wherein the diffusion-resistance layer is from 0.01 μ

m to about 250 μ

m thick.

20. The device of claim 1, wherein the sensor has a drift of less than or equal to 10% over 10 days.

21. The device of claim 1, wherein the sensor comprises an electrode.

22. The device of claim 1, wherein the device is configured for continuous measurement of an analyte concentration.

23. The device of claim 1, wherein the analyte is glucose.

24. The device of claim 1, wherein the base polymer has an ultimate tensile strength as measured by ASTM D1708 that is greater than 6000 psi.

25. The device of claim 1, wherein the base polymer has a plurality of glass transition temperatures as measured using ASTM D3418.

26. A device for monitoring an analyte concentration, the device comprising:

a transcutaneous sensor configured to generate a signal associated with a concentration of an analyte; and

a sensing membrane located over the sensor, the sensing membrane comprising a diffusion-resistance layer, wherein the diffusion-resistance layers comprises a polyurethane containing block copolymer, wherein the sensor has less than 10% change in signal at 2 hrs after start.