Method for improved sensor sensitivity of a microneedle-based continuous analyte monitoring system
Inventors
CAMPBELL, Alan Steven • McKinlay, Robert • Xu, Shuai
Assignees
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Publication Number
US-12336816-B2
Publication Date
2025-06-24
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
A device for use in sensing an analyte includes a microneedle with an electrode material and a biorecognition layer on the electrode material. The biorecognition layer comprises a polymer, a biorecognition element configured to react with the analyte, and an interferent blocking agent that fills voids within the polymer, with at least a portion of the interferent blocking agent in contact with the electrode material. The interferent blocking agent comprises polymerized phenol.
A diffusion-limiting layer is positioned on the biorecognition layer. The polymerized phenol is present within the biorecognition layer at a concentration between about 0.1 mg/ml or 0.01% w/v and about 10 mg/ml or 1% w/v, and the voids may traverse a thickness of the polymer.
The structure is intended to restrict interferent access to the electrode material while enabling analyte sensing. The approach supports mitigation of interference current change over time and one-week stability in microneedle-array continuous analyte monitoring with an electrochemical working electrode.
Claims Coverage
Two independent claims are present. Across the claims, the coverage centers on four core inventive features: a polymer-based biorecognition layer, an interferent blocking agent filling polymer voids, a specified polymerized phenol concentration range, and a diffusion-limiting layer on the biorecognition layer.
Microneedle analyte sensing device with polymerized phenol interferent blocking and diffusion-limiting layer
A device for sensing an analyte comprising a microneedle with an electrode material, a biorecognition layer on the electrode material that includes a polymer, a biorecognition element configured to react with the analyte, and an interferent blocking agent that fills voids within the polymer with at least a portion contacting the electrode material, where the interferent blocking agent comprises polymerized phenol present in the biorecognition layer at a concentration between about 0.1 mg/ml or 0.01% w/v and about 10 mg/ml or 1% w/v, and a diffusion-limiting layer on the biorecognition layer.
Microneedle analyte sensing device with voids traversing polymer thickness and polymerized phenol interferent blocking plus diffusion-limiting layer
A device for sensing an analyte comprising a microneedle with an electrode material, a biorecognition layer on the electrode material that includes a polymer, a biorecognition element configured to react with the analyte, and an interferent blocking agent that fills voids within the polymer, the voids traversing a thickness of the polymer, where the interferent blocking agent comprises polymerized phenol present in the biorecognition layer at a concentration between about 0.1 mg/ml or 0.01% w/v and about 10 mg/ml or 1% w/v, and a diffusion-limiting layer on the biorecognition layer.
Overall claim coverage centers on microneedle-based analyte sensing with an electrode supporting a polymer biorecognition layer containing a polymerized phenol interferent blocking agent filling polymer voids, together with a diffusion-limiting layer positioned on the biorecognition layer.
Stated Advantages
Restricts interferent access to the electrode material while enabling analyte sensing.
Mitigates interference current change over time and supports one-week stability.
Documented Applications
Microneedle-array continuous analyte monitoring, including continuous glucose monitoring (CGM), using an implantable transdermal electrochemical sensor.
Sensing an analyte.
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