Printable hydrogel for biosensors

• US 9,261,476 B2
• Filed: 04/01/2014
• Issued: 02/16/2016
• Est. Priority Date: 05/20/2004
• Status: Active Grant

• Current Assignee: Sanofi-Aventis SA (Sanofi )
• Original Assignee: Sanofi S.A. (Sanofi-Synthélabo SA)
• Inventors: Bartetzko, Norbert
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US14/231,914
• Publication Number:
  US 20140209483A1
• Time in Patent Office: 686 Days
• US Class Current: 1/1
• CPC Class Codes: C08F 10/02 Ethene
• CPC Class Codes: C08F 6/006 Removal of residual monomers by chemical reaction, e.g. scavenging
• CPC Class Codes: C12Q 1/002 Electrode membranes
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

Methods and apparatus are provided for manufacturing an analyte detecting device. In one embodiment, the method comprises providing a substrate, applying a plurality of layer of materials on said substrate; applying a layer containing at least one mediator; and screen printing a hydrogel on the layer.

Claims

1. A method for measuring analyte levels in a body fluid, comprising:

providing an analyte level detection device that includes an analyte detecting member;

the analyte detecting member including a biosensor electrode that includes a cross-linkable hydrophilic polymer dispersion containing a hydrophilic monomer mixture, a low molecular weight cross-linker and a hydrophilic high molecular weight polymer and an initiator, the biosensor including a zwitterionic-surfactant, the hydrophilic molecular weight polymer including a non-ionic co-surfactant, the co-surfactant having surface active properties that increase a mobility of a mediator, the biosensor electrode having an upper portion distal from a substrate that is wider that a lower portion coupled to the upper portion and to the substrate, at least a portion of the biosensor electrode being screen printed.

2. The method of claim 1, wherein the low molecular weight cross-linker and the high molecular weight polymer are used in combination with at least one of:

a hydrophilic, (partially) vinyl functionalized high molecular weight polymer.

3. The method of claim 1, wherein said compound is configured to allow rapid wicking of the analyte solution as well as rapid swelling of the resulting hydrogel membrane to allow a fast diffusion of the analyte to the enzyme.

4. The method of claim 1, wherein the compound is configured to achieve a cross-linked hydrogel to allow the permeation of low molecular weight analytes to the entrapped enzyme.

5. The method of claim 1, wherein the compound includes at least one of, N-vinyl pyrrolidone, ethylene oxide, acrylic or methacrylic acid and salts, esters and amides thereof, vinyl alcohol and derivatives thereof and glucose and the derivatives thereof.

6. The method of claim 1, wherein the compound can be partially vinyl functionalized and entrapped in or covalently bond to a formed poly vinyl matrix by thermal- or UV induced radical polymerization.

7. The method of claim 1, wherein the compound includes a di- or polyvinylfunctional macromolecular substance based on di- or polyhydroxy-functionized polymers selected from at least one of, polyvinyl alcohol and derivatives thereof, poly ethylene glycol, polyalkylene oxide, polysaccharides or hydroxy terminated polyurethane'"'"'s and a macromolecular cross-linker.

8. The method of claim 1, further comprising water-soluble vinyl monomers selected from at least one of:

acrylic and methacrylic acid and salts, amides and esters thereof, N-vinyl pyrrolidone and other water-soluble vinyl monomers.

9. The method of claim 1, wherein the cross linker is a low molecular weight cross-linker selected from at least one of, di- or polyesters, -ethers, -amides of acrylic or methacrylic add and other radically polymerisable vinyl compounds.

10. The method of claim 1, wherein the initiator is a thermal or photochemical initiator selected from at least one of:

(functionalized) alkylphenones or redox initiators, preferably UV-cleavable initiators.

11. The method of claim 1, further comprising,

at least one surfactant, which enhances the wettability of an analyte solution on a surface as well as a swelling of an hydrogel coating in contact with the analyte solution.

12. The method of claim 11, wherein the surfactants are non-ionic surfactants selected from at least one of, alkylphenol polyglycol ethers, sorbitan esters, (ethoxylated) alkin dolls (partially) fluorinated nonionic surfactants, anionic surfactants, alkylsulfonates, alkylbenzenesulfonates or (partially) fluorinated surfactants, or zwitter-ionic surfactants, zwitter-ionic cholic acid derivatives or detain sulfates.

13. The method of claim 11, wherein the surfactant (mixture) increases the wettability of the polymer dispersion applied on the more hydrophobic substrate surface by means of (screen-) printing.

14. The method of claim 1, wherein the polymer includes additives enabling printability, selected from at least one of, defoamers, retarders, pigments, dyes and further rheological additives.