Continuous analyte monitoring system with microneedle array
Inventors
CAMPBELL, Alan Steven • Windmiller, Joshua Ray • Tangney, Jared Rylan
Assignees
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Publication Number
US-12279888-B2
Publication Date
2025-04-22
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. The microneedle array may include, for example, at least one microneedle including a tapered distal portion having an insulated distal apex, and an electrode on a surface of the tapered distal portion located proximal to the insulated distal apex. At least some of the microneedles may be electrically isolated such that one or more electrodes is individually addressable.
Core Innovation
The invention relates to an analyte monitoring device that includes a semiconductor substrate and a microneedle array extending from a first side of the semiconductor substrate. The microneedle array includes solid microneedles with multiple electrodes, including working electrodes with biorecognition elements configured to react with an analyte, as well as counter electrodes and a reference electrode.
The device specifies placement relationships for the electrodes on the microneedle array. The first working electrode and the second working electrode are positioned at a periphery of the microneedle array on the first side of the semiconductor substrate, and each working electrode is positioned equidistant to one of the counter electrodes and equidistant to the reference electrode. The first biorecognition element and the second biorecognition element are the same.
In an enzyme-based configuration, the biorecognition elements are enzyme-based biorecognition elements configured to react with the analyte, and the same enzyme-based biorecognition element is used at both working electrodes. The device includes an analog front end configured to maintain fixed potential relationships between each working electrode and the reference electrode while allowing a counter electrode voltage to swing to sustain redox reactions at the first working electrode and the second working electrode.
Claims Coverage
The document provides two independent claims. Across these independent claims, there are two core inventive groupings: electrode layout with equidistant positioning relationships using first and second working electrodes that carry the same biorecognition element, and analog front-end control that maintains fixed working-to-reference potential relationships while allowing counter-electrode voltage swing to sustain redox reactions at both working electrodes.
Microneedle array electrode layout with periphery working electrodes and equidistance relationships
An analyte monitoring device comprising a semiconductor substrate and a microneedle array with solid microneedles including a first microneedle with a first working electrode having a first biorecognition element, a second microneedle with a second working electrode having a second biorecognition element, a third microneedle with a first counter electrode, a fourth microneedle with a second counter electrode, and a fifth microneedle with a reference electrode, wherein the first biorecognition element and the second biorecognition element are the same; wherein the first and second working electrodes are positioned at a periphery of the microneedle array on the first side; wherein each working electrode is positioned equidistant to one of the counter electrodes and equidistant to the reference electrode.
Analog front end with fixed working-to-reference potential relationships and counter-electrode voltage swing for dual redox
An analyte monitoring device comprising a semiconductor substrate and a microneedle array with first and second working electrodes having enzyme-based biorecognition elements configured to react with the analyte, wherein the first and second biorecognition elements are the same; wherein the first and second working electrodes are positioned at a periphery of the microneedle array on the first side; wherein each working electrode is positioned equidistant to one of the counter electrodes and equidistant to the reference electrode; and an analog front end configured to maintain a first fixed potential relationship between the first working electrode and the reference electrode and a second fixed potential relationship between the second working electrode and the reference electrode, and allow a counter electrode voltage to swing to sustain a first redox reaction at the first working electrode and a second redox reaction at the second working electrode.
Both independent claims center on an analyte monitoring device that uses a semiconductor substrate with a microneedle array and multiple electrodes including two working electrodes that each carry the same biorecognition element. Claim coverage further constrains electrode placement using periphery positioning and equidistance relationships, and in the enzyme-based device adds an analog front end that maintains fixed working-to-reference potential relationships while allowing counter-electrode voltage swing to sustain redox reactions at both working electrodes.
Stated Advantages
Reduced diffusion latency.
Improved correlation to blood.
Reduced pain.
Device feasibility with ethylene oxide (EO) sterilization compatible with integrated electronics.
Sensor stability with retained sensitivity and operation over days, including dry storage.
Documented Applications
Continuous glucose monitoring (CGM) / continuous analyte monitoring system.
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