Analyte sensor
Inventors
Shah, Rajiv • Liang, Bradley • Wolfe, Katherine • Messer, Ellen K • Pendo, Shaun M
Assignees
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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.
Core Innovation
The invention relates to an in vivo electrochemical analyte sensor using a working conductor with a sensing surface portion and a reactive region exposed through an insulation layer window or opening. A multilayer enzyme layer is disposed on the sensing surface portion, with the enzyme layer filling the window or opening and protruding above the insulator top surface. A multilayer raised boss protrudes above the insulator and covers the enzyme layer, and the raised boss includes a first transport material and a second transport material arranged to control transport toward the reactive region.
The core structure creates a multilayer transport pathway in which the first transport material is permeable to a target analyte, including transport through one or more exposed lateral surfaces, while the second transport material is permeable to a reactant and impermeable to the target analyte. The enzyme layer and the complementary transport materials act together so that the target analyte and the reactant are directed toward the sensing region in controlled and dissimilar ways. The target analyte and the reactant flux are separated by their permeability properties and by the spatial geometry of the multilayer raised boss.
The invention further includes electrode geometries such as an aperture/via and a boss/raised protrusion, including structures in which enzyme and reactant/analyte transport are managed to mitigate effects of metabolically active/occluding cells and reaction byproducts. The multilayer design is described as enabling “factory-calibrated” sensing without correction factors and as facilitating complete electrochemical consumption of reaction byproducts, including hydrogen peroxide. Additional refinements include multilayer placement and flux pathways that reduce interference effects and maintain calibration/linearity across conditions such as oxygen levels, including multi-analyte sensor variations and pseudo-reference electrode formation.
Claims Coverage
The document provides two independent claim sets. Across these independent claims, four inventive areas are tied to controlling analyte flux and reactant flux toward a reactive sensing surface using permeability-selective first and second transport materials.
Multilayer working electrode with insulator window and raised boss transport control
A multilayer working electrode with a working conductor having a planar top surface including a sensing surface portion; an insulator layer applied to the planar top surface with a window exposing the sensing surface portion; an enzyme layer disposed on the sensing surface portion, the enzyme layer filling the window and protruding above the insulator; and a multilayer raised boss rising above the insulator top surface and covering the enzyme layer, where the boss includes a layer of first transport material permeable to a target analyte with one or more exposed lateral surfaces, and a layer of second transport material over the top surface of the first transport material sealing the top surface over the window, the second transport material being permeable to a reactant and impermeable to the target analyte.
Working electrode with insulation opening, fill material, and raised boss
A working electrode with a multilayer structure including a working conductor between a first insulation layer and a second insulation layer, the first insulation layer having an opening exposing a sensing surface portion; a first fill material applied to at least a portion of the sensing surface portion within the opening and rising above a top surface of the first insulation layer; and a raised boss rising above and protruding away from the top surface of the first insulation layer, where the raised boss includes a first transport material applied over the first fill material, covering the opening and a portion of the top surface around the opening, the first transport material permitting analyte flux through one or more exposed lateral surfaces into the first fill material, and a second transport material applied over and sealing a top surface of the first transport material over the opening, the second transport material permitting reactant flux to the working conductor through the top surface of the second transport material and being impervious to the target analyte.
Both independent claims center on a raised boss/multilayer transport architecture that uses a first transport material permeable to a target analyte and a second transport material permeable to a reactant but impermeable to the target analyte, while exposing a sensing or reactive region through an insulator window or opening. The first independent claim incorporates an enzyme layer filling the window and a second transport material sealing the first transport material over the window; the second independent claim incorporates a first fill material rising above the insulation and covered by first and second transport materials arranged to permit analyte and reactant flux in different permeability-selected pathways.
Stated Advantages
Enables “factory-calibrated” sensing without correction factors.
Creates concentration gradients enabling complete electrochemical consumption of reaction byproducts, including hydrogen peroxide.
Mitigates effects of metabolically active/occluding cells, including blood cells.
Helps maintain calibration and linearity across conditions such as oxygen levels.
Supports interference rejection via transport/modulator and chemistry layers.
Documented Applications
In vivo electrochemical analyte sensors, including glucose and lactate sensing, with electrode designs including aperture/via and boss/raised protrusion geometries.
Testing and validation in buffer and “faux vivo” bovine blood conditions, including calibration, linearity, and stability across oxygen levels.
Multi-analyte sensor configurations and electrode-system variations including pseudo-reference electrode formation.
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