US 12,414,717 B2
Analyte and environment sensors
Mark A. Adler, Carlsbad, CA (US)
Assigned to Canary Medical Switzerland AG, Baar (CH)
Filed by CANARY MEDICAL SWITZERLAND AG, Baar (CH)
Filed on Feb. 21, 2025, as Appl. No. 19/060,352.
Application 19/060,352 is a continuation of application No. 19/058,608, filed on Feb. 20, 2025.
Application 19/058,608 is a continuation of application No. 18/726,761, previously published as PCT/US2023/010832, filed on Jan. 13, 2023.
Claims priority of provisional application 63/299,343, filed on Jan. 13, 2022.
Prior Publication US 2025/0235131 A1, Jul. 24, 2025
Int. Cl. A61B 5/145 (2006.01); A61B 5/00 (2006.01); A61B 5/01 (2006.01); A61B 5/1473 (2006.01)
CPC A61B 5/14735 (2013.01) [A61B 5/0002 (2013.01); A61B 5/01 (2013.01); A61B 5/1451 (2013.01); A61B 5/14532 (2013.01); A61B 5/14546 (2013.01); A61B 5/6847 (2013.01); A61B 5/7225 (2013.01); A61B 5/742 (2013.01); A61B 2560/0209 (2013.01); A61B 2560/045 (2013.01); A61B 2560/0468 (2013.01); A61B 2562/0271 (2013.01); A61B 2562/046 (2013.01); A61B 2562/16 (2013.01); A61B 2562/18 (2013.01); A61B 2562/227 (2013.01)] 29 Claims
OG exemplary drawing
 
1. A sensor device for in vivo monitoring of analytes, comprising:
a substrate comprising an electrically non-conductive material, wherein the substrate is a wafer-based substrate comprising silicon oxide and includes an upper surface having a plurality of ridges to provide a three-dimensional profile to the sensor device;
an electrochemical sensor electrode contingent disposed on the substrate and configured to detect a target analyte in a body fluid when the electrochemical sensor electrode contingent is deployed fully within a subject's body, the electrochemical sensor electrode contingent comprising, and optionally consisting of, a working electrode and a reference electrode associated with the working electrode, wherein the electrochemical sensor electrode contingent has a morphology corresponding to the three-dimensional profile provided by the substrate, wherein the working electrode is functionalized by a chemical layer configured to facilitate a reaction involving the target analyte that produces an electrical signal at the electrochemical sensor electrode contingent, wherein the reference electrode includes iridium oxide and the working electrode includes platinum and iridium, and wherein the sensor device is operable to detect the target analyte at a low power consumption based on an applied voltage at the reference electrode of greater than or equal to about 110 mV and less than 300 mV, less than 285 mv, or less than 175 mV,
wherein the chemical layer includes a membrane comprising (i) an outer layer exposed to the body fluid configured to regulate permeation of reactive species including the target analyte and (ii) an inner layer coupled between the outer layer and the surface of the working electrode to immobilize a catalyst able to facilitate the reaction by the permeated reactive species for detection of the target analyte at the working electrode, wherein the membrane includes a plurality of ripples on a top surface of the outer layer;
a plurality of electrodes disposed on the substrate and configured to detect a parameter associated with electrical conductivity of the body fluid across at least two electrodes of the plurality of electrodes when the sensor device is deployed within the subject's body, wherein the at least two electrodes are configured to operate as an AND gate, such that when the body fluid is in contact with both of the two electrodes, a short circuit occurs across the two electrodes that corresponds to a one and one signal of the AND gate detectable by the sensor device; and
an electronics unit in communication with the electrochemical sensor electrode contingent, the electronics unit comprising a wireless communications unit including a wireless transmitter or wireless transceiver to transmit data associated with the electrical signal to an external processor,
wherein, the external processor is operable to determine a parameter associated with the target analyte based on the electrical signal measured at the electrochemical sensor electrode contingent, and wherein the processor is configured to determine from the same electrical signal produced at the electrochemical sensor electrode contingent a change in an environmental condition including temperature within a deployment zone when the electrochemical sensor electrode contingent is deployed within the subject's body.