Continuous analyte monitoring system with microneedle array
Inventors
Campbell, Alan • Sattayasamitsathit, Sirilak • Tangney, Jared Rylan • Windmiller, Joshua Ray • McCanna, James Patrick
Assignees
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Publication Number
US-12285271-B2
Publication Date
2025-04-29
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 implantable/skin-adhered continuous analyte monitoring system that uses a microneedle array formed on a semiconductor substrate. The plurality includes a first microneedle with a first working electrode that includes a first biorecognition element configured to react with the analyte, a second microneedle with a second working electrode that includes a second biorecognition element configured to react with the analyte, and a third microneedle including a counter electrode.
Each of the first microneedle, the second microneedle, and the third microneedle is insulated from the semiconductor substrate and electrically isolated from one another. This electrical isolation makes a first redox reaction between the first working electrode and the counter electrode independent from a second redox reaction between the second working electrode and the counter electrode, so the first and second sensing channels operate independently using separate electrochemical reactions.
In the associated sensing method, a first bias potential is applied between a first working electrode on the first microneedle and a reference electrode, and a second bias potential is applied between a second working electrode on the second microneedle and the reference electrode. First and second current values are measured between the respective working electrodes and a counter electrode, where each current value is proportional to a concentration of the analyte, and the first and second microneedles are insulated from the semiconductor substrate and electrically isolated from one another so the first and second current values are independent.
The document further describes shallow dermal insertion depth to reduce diffusional lag and pain, and includes electrode stack, diffusion-limiting, and hydrophilic layer concepts. System-level architecture is described with a wearable housing, electronics, wireless communication, and user interface indicators.
Claims Coverage
The document includes two independent claims. Both independent claims center on a microneedle array and sensing method that use insulation and electrical isolation to make multiple electrochemical reactions and current values independent, enabling multiple sensing channels.
Electrically isolated, insulated microneedle sensing channels with independent redox reactions
A microneedle array for sensing an analyte includes a semiconductor substrate and microneedles where a first microneedle includes a first working electrode with a first biorecognition element, a second microneedle includes a second working electrode with a second biorecognition element, and a third microneedle includes a counter electrode; the first, second, and third microneedles are insulated from the semiconductor substrate and electrically isolated from one another such that a first redox reaction and a second redox reaction are independent of one another.
Independent current measurements proportional to analyte concentration using isolated microneedles and dual bias potentials
A method for sensing an analyte via a microneedle array applies a first bias potential between a first working electrode on a first microneedle and a reference electrode and applies a second bias potential between a second working electrode on a second microneedle and the reference electrode, measures a first current value between the first working electrode and a counter electrode proportional to a concentration of the analyte and measures a second current value between the second working electrode and a counter electrode proportional to a concentration of the analyte, wherein each of the first and second microneedles is insulated from the semiconductor substrate and electrically isolated from one another so the first current value and the second current value are independent of one another.
Across the independent claims, the core claim coverage is the use of insulated and electrically isolated microneedles on a semiconductor substrate to achieve independent electrochemical reactions and independent sensing outputs from separate working electrodes using biorecognition elements and a counter and reference electrode configuration.
Stated Advantages
Shallow dermal insertion depth to reduce diffusional lag and pain.
Electrical isolation enables multiple independent and parallel electrochemical measurements.
Retained glucose sensitivity after ethylene oxide sterilization is stated (about 75% average).
Sensor operational stability is stated in PBS over seven days.
Sensor storage stability during dry storage is stated.
Allows independent operation of a first redox reaction and a second redox reaction so the sensing signals are independent of one another.
Enables first and second current values proportional to analyte concentration to be independent of one another.
Documented Applications
Continuous analyte monitoring using an implantable/skin-adhered continuous analyte monitoring system.
Multiple-analyte sensing is described as optional.
Post-sterilization stability of an analyte monitoring sensor after ethylene oxide (EO) exposure, including retained sensitivity during dry storage and during active operation.
Sensing and monitoring an analyte using a microneedle array that can access dermal interstitial fluid by skin insertion into an upper dermis/papillary region.
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