CONTINUOUS GLUCOSE MONITORING SYSTEM AND METHOD Russian patent published in 2022 - IPC A61B5/145 

FIELD: medical equipment.

SUBSTANCE: group of inventions relates to continuous glucose monitoring. Device for introduction is intended for implantation of electrochemical sensor of continuous monitoring of glucose subcutaneously, wherein the assembly comprises: a housing of an insertion device with an annular wall of the housing defining a wall within the surface, a first end of the housing, a second end of the housing and a housing locking mechanism, wherein annular wall of housing has at least one cam surface, extending longitudinally along part of the wall inside the surface from the cutout located at a distance from the first end of the housing to the second surface of the stop located at a distance from the second end of the housing, wherein at least one cam surface reduces the thickness of the annular wall of the housing along the at least one cam surface from the notch to the second surface of the stop; an installation button with at least a second end of the button, at least one resilient blocking stop configured to slide along at least one cam surface of the annular wall of the housing, the installation button is at least partially located in the housing of the insertion device and is configured to slide therein through the first end of the housing, wherein the second end of the button is located within the housing of the insertion device, wherein the setting button is movable only from the first position, in which the larger part of the setting button is located outside the housing of the insertion device, into the second position, in which a smaller part of the installation button is located outside the housing of the introduction device; needle assembly having a needle holder, a needle assembly resilient support and a hollow needle with an open portion of a sharp object forming a recess, wherein the hollow needle is rigidly attached to the needle holder, the needle assembly is located within the installation button with possibility of sliding and can only move from the ready position to the retracted position, wherein when the needle assembly is in the ready position, the hollow needle exits from the second end of the installation button. At that, the continuous glucose monitoring electrochemical sensor installation unit is connected in a removable manner to the installation button on the second end of the button, wherein the sensor installation unit has a needle hole, through which the hollow needle passes when the needle assembly is in a ready position, and an electrochemical sensor assembly with a distal end portion, a proximal end portion and a middle portion of the assembly, wherein the continuous glucose monitoring electrochemical sensor assembly is partially placed within the cavity and within the hollow needle, wherein the continuous glucose monitoring electrochemical sensor assembly comprises a base layer, defining at least one circuit with an electrically conductive contact shield on each of the base proximal end portion and the base distal end portion, a median layer arranged on the base layer and defining at least two circuits, wherein each of the at least two circuits has an electrically conductive contact shield formed on each of the proximal end portion of the middle layer and the distal end portion of the middle layer, and a plurality of through holes of the middle layer with side walls, wherein one of the at least two circuits is electrically connected to at least one circuit of the base layer by means of a plurality of through holes of the middle layer, an upper layer arranged on the middle layer, wherein the upper layer has a plurality of contact holes which coincide with each electroconductive contact shield of the proximal end portion, and a plurality of transducer cells that are aligned with each electrically conductive contact shield of the distal end portion, the proximal end portion extending laterally from the needle opening and the hollow needle. Detecting layer disposed in at least one of the plurality of sensor cells and in contact with at least one electrically conductive contact shield of the distal end portion, forms at least a first working electrode, wherein the detecting layer includes a base coating layer, a second coating layer and a third coating layer; and a reference layer disposed in another of the plurality of sensor cells and in contact with a corresponding electrically conductive contact shield of the distal end portion forms at least a reference electrode, and the sensor body is disposed and detachably retained in the second end of the insertion device body, wherein the sensor body has a lower opening therethrough, which is aligned with the hollow needle, for receiving the hollow needle therethrough, wherein moving the set button from the first position to the second position results in a substantially simultaneous action to implant a portion of the electrochemical sensor assembly for continuous monitoring of glucose subcutaneously, retracting the needle assembly into a retracted position, securing the sensor mounting assembly within the sensor body and detaching the insertion device body from the sensor body, note here that at least one cam surface moves the setting button from the first position to the second position so that partial setting is impossible. Also disclosed is a method of using a device assembly for introducing an electrochemical sensor assembly for continuous monitoring of glucose subcutaneously, as well as a continuous glucose monitoring electrochemical sensor assembly for use in a device assembly for subcutaneous implantation of the sensor.

EFFECT: group of inventions provides reducing the probability of causing damage to a large number of nociceptors.

15 cl, 55 dwg, 1 tbl