# US 11,298,059 B2 · Analyte sensor

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- Number: US 11,298,059 B2
- Document ID: US11298059B2
- Status: Granted
- Kind: B2
- Application number: 15/472,194
- Filed: 2017-03-28
- Published: 2017-11-16
- Granted: 2022-04-12
- Earliest claimed: 2016-05-13
- Assignees: PercuSense, Inc.
- Applicants: Percusense, LLC
- Inventors: Rajiv Shah; Bradley Liang; Katherine Wolfe; Ellen K Messer; Shaun M Pendo
- Web page: https://patentgrep.com/patent/US11298059B2

## CPC

- A61B 5/14865: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/1486: using enzyme electrodes, e.g. with immobilised oxidase
- A61B 5/1495: Calibrating or testing of in-vivo probes
- C12Q 1/005: {involving specific analytes or enzymes (including groups of enzymes, e.g. oxydases; C12Q1/004 takes precedence)}
- C12Q 1/006: {for glucose}
- G01N 27/3271: {Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood (amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001)}
- 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 2562/0295: Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- 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)

## Abstract

A working electrode measuring the presence of an analyte is described as one embodiment. The working electrode includes a working conductor with a reactive surface that is operated at a first potential. The working electrode further includes a first transport material with properties that enable analyte flux to the reactive surface. Additionally, the working electrode has a second transport material with properties that enable reactant flux to the reactive surface, wherein the analyte flux and the reactant flux are in dissimilar directions.

## Claims

### Claim 1

A multilayer working electrode comprising:
a working conductor having a planar top surface including a sensing surface portion;
an insulator layer applied to the planar top surface of the working conductor, the insulator layer having a window that exposes the sensing surface portion;
an enzyme layer disposed on the sensing surface portion of the planar top surface of the working conductor, the enzyme layer filling the window of the insulator layer and protruding above a top surface of the insulator layer and covering a portion of the top surface of the insulator layer; and
a multilayer raised boss that rises above, and protrudes away from, the top surface of the insulator layer, the multilayer raised boss covering the enzyme layer and including:
a layer of first transport material disposed over the enzyme layer, the layer of first transport material being permeable to a target analyte and having one or more exposed lateral surfaces; and
a layer of second transport material applied over a top surface of the layer of the first transport material and sealing the top surface of the layer of the first transport material over the window of the insulator layer, the second transport material being permeable to a reactant and impermeable to the target analyte.

### Claim 2 (depends on 1)

The multilayer working electrode of claim 1, wherein the multilayer raised boss has a cylindrical form.

### Claim 3 (depends on 2)

The multilayer working electrode of claim 2, wherein the layer of first transport material and the layer of second transport material are limited to an area over the window and a portion of the top surface of the insulator layer surrounding the window.

### Claim 4 (depends on 3)

The multilayer working electrode of claim 3, wherein the multilayer raised boss does not extend laterally to an outer edge of the working electrode.

### Claim 5 (depends on 1)

The multilayer working electrode of claim 1, wherein the layer of first transport material is configured such that:
the target analyte passes through the layer of first transport material predominantly in a first direction that is parallel with the planar top surface of the working conductor; and
the target analyte enters the layer of first transport material only through the one or more exposed lateral surfaces of the layer of first transport material.

### Claim 6 (depends on 5)

The multilayer working electrode of claim 5, wherein the layer of second transport material is configured such that:
the reactant passes through the layer of second transport material predominantly in a second direction that is non-parallel with the first direction; and
the reactant enters the layer of second transport material through a top surface of the layer of second transport material and through one or more side surfaces of the layer of second transport material.

### Claim 7 (depends on 1)

The multilayer working electrode of claim 1, wherein the layer of second transport material has one or more exposed lateral surfaces configured to receive reactant flux therethrough.

### Claim 8 (depends on 1)

The multilayer working electrode of claim 1, wherein the layer of first transport material of the multilayer raised boss has a diameter that is greater than a diameter of the layer of second transport material of the multilayer raised boss.

### Claim 9 (depends on 1)

The multilayer working electrode of claim 1, wherein the layer of second transport material restricts analyte flux to entry into the multilayer raised boss through the one or more exposed lateral surfaces, thereby inducing lateral diffusion of the analyte flux towards a center of the multilayer raised boss along a dimension that is parallel with the sensing surface portion of the working conductor.

### Claim 10 (depends on 1)

The multilayer working electrode of claim 1, wherein the layer of first transport material covers a lateral side surface of the enzyme layer that is positioned above the top surface of the insulator layer and laterally outside of the window.

### Claim 11

A working electrode comprising:
a multilayer structure that includes a working conductor between a first insulation layer and a second insulation layer, the first insulation layer having an opening that exposes a sensing surface portion of the working conductor;
a first fill material applied to at least a portion of the sensing surface portion of the working conductor within the opening in the first insulation layer, the first fill material rising above a top surface the first insulation layer; and
a raised boss that rises above, and protrudes away from, the top surface of the first insulation layer, the raised boss including:
a first transport material applied over the first fill material, the first transport material covering the opening in the first insulation layer and a portion of the top surface of the first insulation layer around the opening, the first transport material being configured to permit analyte flux of a target analyte through one or more exposed lateral surfaces of the first transport material and to the first fill material; and
a second transport material applied over and sealing a top surface of the first transport material over the opening in the first insulation layer, the second transport material being configured to permit reactant flux to the working conductor through a top surface of the second transport material, the second transport material further being impervious to the target analyte.

### Claim 12 (depends on 11)

The working electrode of claim 11, wherein the first fill material comprises a reactive chemistry configured to react with the target analyte.

### Claim 13 (depends on 12)

The working electrode of claim 12, wherein the reactant flux provides a reactant to a chemical reaction between the reactive chemistry and the target analyte.

### Claim 14 (depends on 10)

The multilayer working electrode of claim 10, wherein the position of the lateral side surface of the enzyme layer outside of the window allows for lateral flux of reaction product of the target analyte and the reactant over the top surface of the insulator layer and into the window.