Membrane layers for analyte sensors

Patent metadata

Field	Value
Publication number	US-2017188916-A1
Application number	US-201615395892-A
Country	US
Kind code	A1
Filing date	Dec 30, 2016
Priority date	Dec 30, 2015
Publication date	Jul 6, 2017
Grant date	—

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.

First claim

What is claimed is:

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 μm to about 250 μm 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.

Assignees

• Dexcom Inc

Inventors

• Wang Shanger
• Boock Robert J
• Dennis Andrew Trinin
• Lee Ted Tang
• Suri Jeff T
• Sze David
• Tapsak Mark A
• Zhang Huashi
• Zou Jiong

Classifications

• A61K36/185

  Magnoliopsida (dicotyledons) · CPC title

• C08G18/4833

  Polyethers containing oxyethylene units · CPC title

• A61K31/137

  Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone} · CPC title

• C08L69/00

  Compositions of polycarbonates; Compositions of derivatives of polycarbonates · CPC title

• A61K33/00

  Medicinal preparations containing inorganic active ingredients · CPC title