# US 12,599,318 B2 · Implantable micro-biosensor and method for operating the same

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- Number: US 12,599,318 B2
- Document ID: US12599318B2
- Status: Granted
- Kind: B2
- Application number: 16/983,148
- Filed: 2020-08-03
- Published: 2021-02-04
- Granted: 2026-04-14
- Earliest claimed: 2019-08-02
- Assignees: Bionime Corporation
- Applicants: Bionime Corporation
- Inventors: Chun-Mu Huang; Chieh-Hsing Chen
- Web page: https://patentgrep.com/patent/US12599318B2

## CPC

- 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 5/1451: {for interstitial fluid}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/1473: invasive, e.g. introduced into the body by a catheter
- A61B 5/14735: {comprising an immobilised reagent}
- A61B 5/14865: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors}
- A61B 2560/0223: of calibration, e.g. protocols for calibrating sensors
- A61B 2560/0468: Built-in electrodes
- A61B 2562/0215: Silver or silver chloride containing
- A61B 2562/0217: Electrolyte containing
- A61B 2562/028: Microscale sensors, e.g. electromechanical sensors [MEMS]
- A61B 2562/125: characterised by the manufacture of electrodes
- A61B 2562/16: Details of sensor housings or probes; Details of structural supports for sensors (A61B2560/0462 takes precedence)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An implantable micro-biosensor includes a substrate, a first working electrode, at least one second working electrode, and at least one counter electrode. The first working electrode includes a first sensing section driven by a first potential difference to measure a physiological signal. The second working electrode includes a second sensing section driven by a second potential difference to consume an interfering substance. The counter electrode cooperates with the first working electrode to measure the physiological signal, cooperates with the second working electrode to consume the interfering substance, and selectively cooperates with the first or second working electrode to regenerate silver halide.

## Claims

### Claim 1

An implantable micro-biosensor for continuously monitoring a physiological parameter of an analyte in a body, comprising:
a substrate having a first surface and a second surface opposite to said first surface, said first surface including a first sensing region for measuring a physiological parameter;
a first working electrode including a first sensing section disposed on said first surface of said substrate and located at the first sensing region, said first sensing section being driven by a first potential difference so as to form a measuring region to measure a physiological signal in response to the physiological parameter of the analyte;
at least one second working electrode disposed on said first surface of said substrate and including a second sensing section proximate to said first sensing section and located at the first sensing region, said second sensing section being driven by a second potential difference to form an interference-eliminating region that is in touch with a surrounding of said first sensing section and at least partially overlaps with said measuring region, so as to simultaneously consume an interfering substance in the body approaching said first and second sensing sections;
at least one counter electrode disposed on said first or second surface of said substrate and including a silver-silver halide, so as to cooperate with said first working electrode to measure the physiological signal, to cooperate with said second working electrode to consume the interfering substance, and to selectively cooperate with said first or second working electrode so as to be driven to regenerate silver halide,
wherein a surface material of said first sensing section includes a first conductive material, and a surface material of said second sensing section includes a second conductive material different from said first conductive material,
wherein said first working electrode is driven by said first potential difference so as to permit said first conductive material to have a first sensitivity that is responsive to the product,
wherein said second working electrode is driven by said second potential difference so as to permit said second conductive material to have a second sensitivity that is responsive to the product and that is smaller than said first sensitivity,
wherein said first sensing section and the second sensing section are aligned in a same plane on the substrate, said second sensing section extends along and is spaced apart from at least a portion of a periphery of said first sensing section, and a ratio of said portion of said periphery of said first sensing section to a total periphery of said first sensing section ranges from 30% to 100%, and
wherein at least three sides of said first sensing section are surrounded by and spaced apart from said second sensing section by a distance; and
a chemical reagent layer covering at least a portion of said first conductive material of said first sensing section and reacting with the analyte to generate a product.

### Claim 2 (depends on 1)

The implantable micro-biosensor according to claim 1, further comprising a third working electrode disposed on said first or second surface of said substrate and proximate to said counter electrode, said counter electrode selectively cooperating with said third working electrode so as to be driven to regenerate silver halide.

### Claim 3 (depends on 2)

The implantable micro-biosensor according to claim 2, wherein said counter electrode and said third working electrode are disposed on said second surface of said substrate and are spaced apart from each other.

### Claim 4 (depends on 1)

The implantable micro-biosensor according to claim 1, wherein said first conductive material is selected from a group consisting of a noble metal, a noble metal derivative, and a combination thereof, and said noble metal is selected from a group consisting of gold, platinum, palladium, iridium, and combinations thereof.

### Claim 5 (depends on 1)

The implantable micro-biosensor according to claim 1, wherein said first conductive material is platinum, and said first potential difference ranges from 0.2 V to 0.8 V.

### Claim 6 (depends on 1)

The implantable micro-biosensor according to claim 1, wherein said second conductive material is carbon, and said second potential difference ranges from 0.2 V to 0.8 V.

### Claim 7 (depends on 1)

The implantable micro-biosensor according to claim 1, wherein said second sensing section is disposed along and spaced apart from at least one side of said first sensing section by a distance of up to 0.2 mm.

### Claim 8 (depends on 1)

The implantable micro-biosensor according to claim 1, wherein the number of said at least one second working electrode is two, said second sensing sections of said second working electrodes are disposed, respectively, along two opposite sides of said first sensing section of said first working electrode.

### Claim 9 (depends on 1)

The implantable micro-biosensor according to claim 1, wherein said counter electrode comprise a mixture of said silver-silver halide and carbon.

### Claim 10 (depends on 1)

The implantable micro-biosensor according to claim 1, wherein said counter electrode at least includes a first layer that contains said silver/silver halide, and a second layer that contains a third conductive material for covering at least a portion of said first layer.

### Claim 11 (depends on 1)

The implantable micro-biosensor according to claim 1, which is configured to operate perpendicularly to a skin of the body, wherein the implantable micro-biosensor has an implanting end portion with a length of up to 6 mm.
