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Publication Number

US-11553862-B2

Patent

Publication Date

2023-01-17

Expiration Date


Abstract

An electrode measuring the presence of an analyte is described as one embodiment. The electrode includes a working conductor with an electrode reactive surface and a first reactive chemistry that is responsive to the analyte. The electrode further includes a first transport material that enables flux of the first analyte to the first reactive chemistry and a second transport material that supplies a reactant to the first reactive chemistry. Wherein the first reactive chemistry does not contact the electrode reactive surface while at least partially shadowing a portion of the electrode reactive surface.

Core Innovation

The invention describes an implantable electrochemical analyte sensor in which a working conductor includes an electrode reactive surface and a first reactive chemistry responsive to a first analyte. The first reactive chemistry is separated from the electrode reactive surface so that it does not contact the electrode reactive surface, while at least partially shadowing a portion of the electrode reactive surface.

The sensor includes a first transport material that enables flux of the first analyte to the first reactive chemistry through an exposed lateral edge of the first transport material. A second transport material is disposed over and configured to supply a reactant to the first reactive chemistry while the first transport material separates the analyte from contacting the electrode reactive surface, and the first reactive chemistry does not extend to the exposed lateral edge.

The document further describes sensor architectures that integrate the floating/non-contact separation concept into manufacturing and array configurations, including multi-analyte and pseudo-reference electrode integration. The disclosed approach is described as improving mass-transport-limited response, reducing issues from oxygen deficiency compared with glucose limiting membranes, stabilizing pH near the reactive chemistry, and enabling factory calibration. It also includes generalization to other analytes using different reactive chemistries and notes optional mitigation of interference using a second reactive chemistry.

Claims Coverage

The independent claims are directed to an analyte sensor with a working conductor and electrode reactive surface, a first reactive chemistry responsive to a first analyte, and a first transport material and a second transport material that deliver analyte and a reactant to the first reactive chemistry while preventing contact between the first reactive chemistry and the electrode reactive surface in a shadowing/non-contact configuration. The independent claims include six inventive features.

Shadowed non-contact reactive chemistry

The first reactive chemistry does not contact the electrode reactive surface while at least partially shadowing a portion of the electrode reactive surface, with the first reactive chemistry not extending to the exposed lateral edge.

Analyte flux through an exposed lateral edge of the first transport material

A first transport material enables flux of the first analyte to the first reactive chemistry through an exposed lateral edge of the first transport material.

Reactant-supplying second transport material disposed over the reactive chemistry

A second transport material disposed over and configured to supply a reactant to the first reactive chemistry.

Biomarker-containing fluid direct pass into first reactive chemistry

First and second transport material exposed surfaces enable flux of the first analyte and a reactant, respectively, to pass directly from a biomarker containing fluid into the first transport material and to the first reactive chemistry.

Direct overlap of reactive chemistry over electrode reactive surface without touch

The first reactive chemistry laterally overlaps the electrode reactive surface but does not touch the electrode reactive surface.

Sandwiched reactive chemistry with direct contact between transport materials laterally outside

The first reactive chemistry is sandwiched by the first transport material and the second transport material, and the first and second transport material are in direct contact with one another in an area laterally outside of the first reactive chemistry.

Overall, the independent claims cover analyte sensor structures that separate the first reactive chemistry from the electrode reactive surface, use transport materials to enable flux of the analyte and reactant to the reactive chemistry, and define specific shadowing/non-contact and layer-contact/overlap relationships, including direct delivery from biomarker-containing fluid and a sandwiched reactive chemistry arrangement with laterally outside direct contact between the transport materials.

Stated Advantages

Improving mass-transport-limited response.

Reducing issues from oxygen deficiency compared with glucose limiting membranes.

Stabilizing pH near the reactive chemistry.

Enabling manufacturing/array configurations including multi-analyte and pseudo-reference electrode integration.

Enabling factory calibration.

Documented Applications

In vivo monitoring using an implantable electrochemical analyte sensor.

Multi-analyte and sensor array configurations including integration of a pseudo-reference electrode.

Generalization to other analytes by using different reactive chemistries and optional interference rejection using a second reactive chemistry.

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