Method and system for confirmation of microneedle-based analyte-selective sensor insertion into viable tissue via electrical interrogation
Inventors
Windmiller, Joshua • Tangney, Jared Rylan
Assignees
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Publication Number
US-12599337-B1
Publication Date
2026-04-14
Expiration Date
Abstract
A system and method to confirm the insertion of an analyte-selective sensor comprising an array of microneedles possessing vertical extent between 200 and 2000 μm into viable tissue is disclosed herein. Mechanical insertion of an analyte-selective sensor is firstly attempted by means of an application of external force. Either during or following this routine, an electrical stimulus is applied between at least two distinct electrodes located within the said analyte-selective sensor; a resultant response is measured. This response is compared with a reference value to determine if insertion was successful. If insertion was successful, no further effort is required and the sensor can operate as intended. However, if insertion was not successful, the user can be instructed to continue to apply additional force to said sensor to achieve successful insertion or otherwise re-apply the said sensor altogether.
Core Innovation
The invention describes confirming insertion of a microneedle-based analyte-selective sensor into cutaneous tissue through electrical interrogation of electrodes and evaluation of the resulting electrical value against a range indicative of insertion. When insertion is indicated, a greater electrical potential is associated with measuring analyte concentration within physiological fluid. The claimed sensor configurations include microneedles with electrodes and a microneedle array.
One claim form also describes providing a direction to the user to apply force to attempt re-insertion when the comparison does not indicate insertion, followed by further electrical evaluation and a greater potential when insertion is indicated. The supplied content does not include the background section, so the problem stated in that section is not explicitly described in patent. The stated focus is insertion confirmation.
Claims Coverage
The four independent claims cover four inventive features for confirming microneedle sensor insertion and, in specified claim forms, proceeding to analyte measurement or user-directed re-insertion.
Insertion confirmation for two microneedles
Claim 1 covers an analyte-selective sensor with first and second microneedles and respective electrodes. Electrical values through cutaneous tissue are evaluated against an insertion-indicative range; when insertion is indicated, a greater electrical potential is used to measure analyte concentration in physiological fluid.
Insertion confirmation for at least two sensor electrodes
Claim 7 covers a microneedle-based analyte-selective sensor with at least two electrodes. The claimed confirmation uses an insertion-indicative range of electrical values, with a greater electrical potential used for analyte concentration measurement when insertion is indicated.
Insertion confirmation for a microneedle array
Claim 13 covers an analyte-selective sensor comprising a microneedle array and at least two electrodes. The claimed method evaluates an electrical value against a range indicative of insertion and uses a greater electrical potential to measure analyte concentration in physiological fluid when insertion is indicated.
User-directed re-insertion after unsuccessful insertion
Claim 17 covers a sensor with first and second microneedles and electrodes. When insertion is not indicated, the user receives a direction to apply force to attempt re-insertion; following the further insertion assessment, a third electrical potential greater than the first and second potentials is applied when insertion is indicated.
The independent claims cover electrical confirmation of insertion across two-microneedle, at-least-two-electrode, and microneedle-array sensor configurations. One independent claim additionally covers user-directed re-insertion when insertion is not indicated.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Confirming insertion of a microneedle-based analyte-selective sensor into cutaneous tissue and measuring analyte concentration within physiological fluid.
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