# US 10,321,858 B2 · Apparatus and methods for transdermal sensing of analytes in interstitial fluid and associated data transmission systems > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,321,858 B2 - Document ID: US10321858B2 - Status: Granted - Kind: B2 - Application number: 14/827,186 - Filed: 2015-08-14 - Published: 2016-03-03 - Granted: 2019-06-18 - Earliest claimed: 2014-08-18 - Assignees: ProteaDX, Inc. - Applicants: ProteaDX, Inc. - Inventors: Jose Antonio Maiz-Aguinaga; Lennart Olsson - Web page: https://patentgrep.com/patent/US10321858B2 ## CPC - A61B 5/14514: {using means for aiding extraction of interstitial fluid, e.g. microneedles or suction} - A61B 5/685: {Microneedles} - A61B 5/0004: {characterised by the type of physiological signal transmitted} - A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement} - A61B 5/14539: {for measuring pH} - A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes} - A61B 5/1473: invasive, e.g. introduced into the body by a catheter - A61B 5/4845: {Toxicology, e.g. by detection of alcohol, drug or toxic products (A61B5/4848 takes precedence)} - A61B 2505/07: Home care - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Provided are transdermal microneedle-based devices for sensing the presence and concentration of analytes such as electrolytes, biomarkers, drugs, and proteins in interstitial fluid. Also provided are methods and systems to transmit the data obtained by wired or wireless connection to a receiver and to relay the data to the user or a clinician. ## Claims ### Claim 1 An apparatus for testing interstitial fluid in a subject comprising a disposable integrated micro-sensing unit and a reusable applicator, wherein the micro-sensing unit comprises a plurality of hollow transdermal microneedles, a microfluidics chamber, one or more sensors capable of detecting the presence or concentration of one or more analytes, a reference electrode, a pH sensor, a temperature sensor, electronic circuitry to control the testing, a casing, a spacer, a vent, and electrical contacts; and wherein the micro-sensing unit is configured to transmit data that result from the testing to a receiver. ### Claim 2 (depends on 1) The apparatus of claim 1 wherein the microneedles, microfluidics chamber, analyte sensors, reference electrode, pH and temperature sensors, and electronic control circuitry are formed in a monolithic block of silicon. ### Claim 3 (depends on 1) The apparatus of claim 1 wherein the microneedles are formed in a first block of silicon and the analyte sensors, reference electrode, pH and temperature sensors, and electronic control circuitry are formed in one or more additional block(s) of silicon. ### Claim 4 (depends on 1) The apparatus of claim 1 wherein the microneedles are formed in a material other than silicon. ### Claim 5 (depends on 1) The apparatus of claim 1 further comprising a substrate, wherein the substrate and microneedles are formed in a material other than silicon; the analyte sensors, reference electrode, pH and temperature sensors, and electronic control circuitry are formed in one or more additional material(s) and placed over the substrate; and the first and additional materials may be the same or different. ### Claim 6 (depends on 5) The apparatus of claim 5, wherein the analyte sensors, reference electrode, pH and temperature sensors, and electronic control circuitry are formed in material(s) other than silicon. ### Claim 7 (depends on 1) The apparatus of claim 1 wherein the microfluidics chamber is a cavity formed by the spacer, a cavity in the casing, or a cavity in a block of material comprising the microneedles. ### Claim 8 (depends on 1) The apparatus of claim 1 wherein the sensor(s) are conductivimetric, voltammetric, or amperometric. ### Claim 9 (depends on 1) The apparatus of claim 1 wherein the interior width of the hollow portion of the microneedles is less than 1 mm, the dimensions of the microfludics chamber are from 10 μm to 2 mm, the lateral dimensions of the micro-sensing unit are from 0.5 mm to 10 mm, and the thickness of the micro-sensing unit is from 0.5 mm to 5 mm. ### Claim 10 (depends on 1) The apparatus of claim 1 wherein the applicator is a pen-like or patch-like device. ### Claim 11 (depends on 1) The apparatus of claim 1 wherein the applicator comprises a battery and electronic circuitry to power the micro-sensing unit. ### Claim 12 (depends on 11) The apparatus of claim 11 wherein the applicator further comprises electronic circuitry to receive data that result from the testing and transmit the data wirelessly or by wire to a smart device or computer. ### Claim 13 (depends on 12) The apparatus of claim 12 wherein the applicator comprises a mechanical, magnetic, or electromagnetic grab-and-hold mechanism and a switch to be actuated by the user. ### Claim 14 (depends on 13) The apparatus of claim 13 wherein actuating the switch initiates the testing event when the device is ready, and wherein the execution of the testing event and transmission of the data are under full automatic control of the control circuitry without further intervention by the user. ### Claim 15 (depends on 1) The apparatus of claim 1 wherein the receiver is a computer, smart phone, smart watch, tablet computing device, or wearable computing device. ### Claim 16 (depends on 1) A method for detecting the presence or concentration of an analyte in a subject, comprising using the apparatus of claim 1 to apply the micro-sensing unit to the subject such that the microneedles contact interstitial fluid in the subject; initiating a testing event and allowing sufficient time for the interstitial fluid to reach the sensor(s); collecting data from the sensor(s) and transmitting the data to a receiver. ### Claim 17 (depends on 16) The method of claim 16 wherein the receiver is a computer, smart phone, smart watch, tablet computing device, or wearable computing device. ### Claim 18 (depends on 17) The method of claim 17 wherein the receiver comprises a software application capable of initiating, controlling, or directing the testing event. ### Claim 19 (depends on 17) The method of claim 17 wherein the receiver communicates the results of the testing to the user. ### Claim 20 (depends on 17) The method of claim 17 wherein the receiver further transmits the data to a server.