Method for improved sensor sensitivity of a microneedle-based continuous analyte monitoring system
Inventors
CAMPBELL, Alan Steven • McKinlay, Robert • Xu, Shuai • Micu, Anderson • CLARY, JACOB
Assignees
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Publication Number
US-12629060-B2
Publication Date
2026-05-19
Expiration Date
Abstract
Described herein are variations of an analyte monitoring system, including an analyte monitoring device. For example, an analyte monitoring device may include an implantable microneedle array for use in measuring one or more analytes (e.g., glucose), such as in a continuous manner. Each microneedle of the microneedle array may include a microneedle body, an electrode material on the microneedle body, a biorecognition layer on the electrode material, a diffusion-limiting layer on the biorecognition layer, an interferent blocking agent, and/or an attachment enhancer between the biorecognition layer and the diffusion-limiting layer, where the interferent blocking agent and the attachment enhancer are configured to improve sensor sensitivity variability.
Core Innovation
The disclosed device for sensing an analyte comprises a microneedle and a working electrode disposed on the microneedle. The working electrode includes an electrode material and a biorecognition layer disposed on the electrode material. The biorecognition layer comprises a polymer having voids, a biorecognition element configured to react with the analyte, and an interferent blocking agent that fills at least a plurality of the polymer voids to limit interferent access to the electrode material.
Incorporating an interferent blocking agent, such as phenol or polyphenol, into the biorecognition layer reduces background current, sensitivity variability, sensitivity drift over several days, and interferent sensitivity to compounds like acetaminophen. Furthermore, the microneedle-array layout isolates reference electrodes from working-to-counter-electrode current to improve working-electrode bias stability under variable tissue resistance. Illustrated configurations include microneedle arrays with working-, counter-, and reference-electrode layer stacks and optional attachment enhancers.
Claims Coverage
The claims identify one independent claim and associated dependent claims covering five inventive features directed to a microneedle analyte-sensing device and its working-electrode biorecognition layer.
Microneedle working electrode
A device for use in sensing an analyte comprises a microneedle and a working electrode on the microneedle, wherein the working electrode comprises an electrode material on the microneedle and a biorecognition layer on the electrode material.
Interferent blocking agent in polymer voids
The biorecognition layer comprises a polymer having voids therein, a biorecognition element configured to react with the analyte, and an interferent blocking agent that fills at least a plurality of the voids within the polymer.
Specified void filling and interferent-current response
The interferent blocking agent fills at least about 80% of the polymer's voids to limit interferent access to the electrode material, and interferent current at the electrode material changes by less than 70% over a one-week period.
Microneedle-array electrode arrangement
An array comprises working-electrode microneedles arranged between a reference-electrode microneedle and a plurality of counter-electrode microneedles.
Gradient distribution of the blocking agent
The interferent blocking agent forms a gradient within the voids in the biorecognition-layer polymer.
The claim coverage centers on a microneedle working electrode whose analyte-reactive biorecognition layer includes a voided polymer and a void-filling interferent blocking agent, with further claim elements specifying void-filling thresholds, interferent-current stability over time, microneedle-array arrangements, and a gradient distribution of the blocking agent.
Stated Advantages
Filling polymer voids with an interferent blocking agent, including filling at least about 80% of the voids, limits interferent access to the electrode material, reducing background current and sensitivity variability.
Incorporating an interferent blocking agent into the working-electrode biorecognition layer reduces acetaminophen interference sensitivity and variability over time, including an observed reduction of about 75% in median acetaminophen sensitivity and reduced interference in PPh-treated conditions relative to controls.
Phenol-based blocking-agent concentration generally reduces sensitivity drift over several days.
The microneedle-array electrode layout improves working-electrode bias stability under variable tissue resistance by isolating reference electrodes from working-to-counter-electrode current.
Documented Applications
A microneedle device for use in sensing an analyte, comprising a working electrode and a biorecognition layer.
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