# US 12,601,706 B2 · Analyte sensor and a method for its producing

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- Number: US 12,601,706 B2
- Document ID: US12601706B2
- Status: Granted
- Kind: B2
- Application number: 18/442,749
- Filed: 2024-02-15
- Published: 2024-08-15
- Granted: 2026-04-14
- Earliest claimed: 2021-08-18
- Assignees: Roche Diabetes Care, Inc.
- Applicants: Roche Diabetes Care, Inc.
- Inventors: Kirill Sliozberg
- Web page: https://patentgrep.com/patent/US12601706B2

## CPC

- G01N 27/403: Cells and electrode assemblies
- A61B 5/0537: Measuring body composition by impedance, e.g. tissue hydration or fat content
- A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- G01N 27/301: {Reference electrodes}
- G01N 27/3272: {Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels (optical biosensors G01N33/52)}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 2562/0215: Silver or silver chloride containing
- A61B 2562/028: Microscale sensors, e.g. electromechanical sensors [MEMS]
- A61B 2562/0295: Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
- A61B 2562/125: characterised by the manufacture of electrodes
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An analyte sensor for determining at least one analyte and a method for producing an analyte sensor are disclosed. The analyte sensor comprises: a substrate; a working electrode and a conductive layer located on different sites on the substrate; a silver comprising layer partially covering the conductive layer; and a protective layer, which comprises at least one electrically conductive material; and covers the silver comprising layer apart from at least one at least one hole that provides access for at least one body fluid comprising the at least one analyte to the silver comprising layer. Although the analyte sensor as disclosed herein has a reduced overall size, sufficient space is, nevertheless, provided for the silver comprising layer coated by the protective layer while, concurrently, further sufficient space remains which is neither coated by the silver comprising layer nor by the protective layer.

## Claims

### Claim 1

An analyte sensor for determining at least one analyte, comprising,
a substrate;
a working electrode and a conductive layer located on different sites on the substrate;
a silver comprising layer partially covering the conductive layer; and
a protective layer, which
comprises at least one electrically conductive material, and
covers the silver comprising layer apart from at least one hole in the protective layer, the at least one hole extending through the at least one electrically condutive material to the silver comprising layer, providing access for at least one body fluid comprising the at least one analyte to the silver comprising layer.

### Claim 2 (depends on 1)

The analyte sensor according to claim 1, wherein the conductive layer, the silver comprising layer, and the protective layer form a further electrode selected from a group consisting of a counter electrode, a reference electrode, and a combined counter/reference electrode.

### Claim 3 (depends on 2)

The analyte sensor according to claim 2, wherein the at least one further electrode is or comprises the combined counter/reference electrode.

### Claim 4 (depends on 2)

The analyte sensor according to claim 2, wherein the working electrode is located on a first side of the substrate and wherein the further electrode is located on a second side of the substrate, wherein the first side and the second side of the substrate are positioned opposite each other.

### Claim 5 (depends on 4)

The analyte sensor according to claim 4, wherein the working electrode and the further electrode are located on the substrate in a manner that a geometrical projection of a site of the working electrode onto the second side of the substrate on which the silver comprising layer is located does not result in overlap between the geometrical projection of the site of the working electrode and a site of the silver comprising layer.

### Claim 6 (depends on 1)

The analyte sensor according to claim 1, further comprising an electrically insulating layer being located on a same side of the substrate as the silver comprising layer.

### Claim 7 (depends on 1)

The analyte sensor according to claim 1, wherein at least one of the conductive layer or the protective layer comprise an electrically conductive carbon material.

### Claim 8 (depends on 1)

The analyte sensor according to claim 1, wherein the silver comprising layer comprises Ag/AgCl.

### Claim 9 (depends on 1)

The analyte sensor according to claim 1, wherein the protective layer is a hydrophobic layer.

### Claim 10 (depends on 1)

The analyte sensor according to claim 1, wherein the at least one hole has a total size of 0.0005 mm2 to 0.01 mm2.

### Claim 11 (depends on 1)

The analyte sensor according to claim 1, wherein the protective layer comprises 1 to 250 holes.

### Claim 12 (depends on 1)

A method for producing the analyte sensor according to claim 1, the method comprising the steps of:
a) providing the substrate;
b) applying the conductive layer on the substrate;
c) applying the silver comprising layer in a manner that it partially covers the conductive layer;
d) applying the protective layer, which comprises the at least one electrically conductive material, in a manner that it covers the silver comprising layer;
e) generating the at least one hole in the protective layer in a manner that it provides access for the at least one body fluid comprising the at least one analyte to the silver comprising layer; and
f) preparing the working electrode on the substrate.

### Claim 13 (depends on 12)

The method according to claim 12, wherein the at least one hole in the protective layer is generated by using an ablative process.

### Claim 14 (depends on 13)

The method according to claim 13, wherein the at least one hole in the protective layer is generated by using laser ablation.

### Claim 15 (depends on 12)

The method according to claim 12, further comprising a step of g) applying an electrically insulating layer on a same side of the substrate as the silver comprising layer.

### Claim 16 (depends on 12)

The method of claim 12 wherein step e) is performed after step d).
