Continuous analyte monitoring system with microneedle array
Inventors
Tangney, Jared Rylan • Windmiller, Joshua Ray • YANG, Richard Chien
Assignees
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Publication Number
US-11872055-B2
Publication Date
2024-01-16
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 a microneedle array for sensing an analyte in dermal interstitial fluid of a user. At least one solid microneedle extends from a semiconductor substrate and includes a columnar body portion and a tapered distal portion that ends in an insulated distal apex. An annular working electrode is coupled to a surface of the tapered distal portion and is arranged over an annular recess so that the working electrode extends onto the surface on each side of the annular recess.
The microneedle array architecture supports electrochemical sensing by positioning an annular working electrode around a recess formed on the tapered distal portion surface. Additional refinements described in the provided material include the ability for the annular electrode to function as a working, counter, or reference electrode, and the inclusion of an electrical contact on the substrate backside with a conductive pathway through the microneedle body to the working electrode.
The described systems further use the microneedle array in a wearable analyte monitoring context in which microneedle insertion depth targets dermal interstitial fluid rather than surface layers. The wearable housing and applicator position the sensor through stratum corneum toward dermis, and the sensing arrangement is coupled to wireless connectivity and on-device processing to provide analyte level and trend outputs with user interface indicators.
Claims Coverage
The independent claim set contains one independent claim (clm-00001). It covers a microneedle-array sensing structure with a specific electrode-on-tapered-portion arrangement, and additional refinements in dependent claims add conductive pathways, geometric offset constraints, biorecognition layer options, electrode roles, and system-level positional constraints.
Microneedle array with annular working electrode over annular recess on tapered distal portion
A microneedle array for sensing an analyte in dermal interstitial fluid, comprising a semiconductor substrate; a plurality of solid microneedles extending from the substrate, wherein at least one microneedle includes a columnar body portion; a tapered distal portion having an insulated distal apex; and an annular working electrode coupled to a surface of the tapered distal portion, wherein a portion of the working electrode overlies and extends beyond an annular recess formed in the surface of the tapered distal portion, and wherein the working electrode extends onto the surface of the tapered distal portion on each side of the annular recess.
Overall, the claim coverage focuses on a solid semiconductor microneedle with a tapered distal portion and an insulated distal apex, combined with an annular working electrode that overlies and extends beyond an annular recess on the tapered surface. The dependent claim refinements add electrode contacting via a backside electrical contact and conductive pathway, specify geometric offset constraints, specify biorecognition chemistry options, permit annular electrode role flexibility (working/counter/reference), and define system-level placement constraints for the working electrode distal end relative to a wearable housing.
Stated Advantages
Improved performance versus conventional CGM, including reduced diffusion latency and reduced pain through shallow dermal insertion.
Shortened warm-up/response time.
Optimized sensor/biorecognition layers for sensing.
Improved accuracy and reduced insertion-related artifacts by positioning electrodes proximal/offset from the insulated distal apex.
Independent addressability enabling parallel redundant sensing and multi-analyte operation.
Compatibility with ethylene oxide (EO) sterilization while retaining sensitivity and operational/storage stability after EO.
Documented Applications
Wearable continuous analyte monitoring using an implantable semiconductor microneedle array with electrochemical electrodes and wireless communication to a mobile device/user interface.
Multi-analyte operation enabled by individually electrically isolatable microneedles with independent addressability.
Redundant sensing for improved monitoring via parallel redundant sensing from electrically isolatable microneedles.
Sterilized deployment using ethylene oxide (EO) sterilization while maintaining sensitivity and stability after EO.
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