Implantable electrochemical biosensor, test method and implantable medical device

Abstract

The invention relates to the field of biosensors, and provides an implantable electrochemical biosensor, a test method and an implantable medical instrument.The implantable electrochemical biosensor comprises an electroactive domain, a working electrode and a reference electrode, the working electrode and the reference electrode are separated through an insulating layer, and the working electrode and the reference electrode make contact with the electroactive domain; the flexible conductive film is electrically connected with the reference electrode, and the flexible conductive film is not in direct contact with the working electrode. The invention also discloses a test method of the sensor, wherein the reference electrode is electrically connected with the test assembly through the flexible conductive film. The invention further discloses an implantable medical device using the sensor, the sensor can be in a bent state, and the reference electrode is electrically connected with the implantable medical device through the flexible conductive film. The sensor can still work normally after being bent at will, the detection process can be simplified, safety is improved, and corrosion and adhesion between the sensor and the inner wall of a puncture needle are avoided.

Description

technical field [0001] The present application relates to the field of biosensors, in particular to an implantable electrochemical biosensor, a testing method and an implantable medical device. Background technique [0002] Implantable medical devices for determining the presence and concentration of biological analytes, including partially implanted sensors and in vitro electronics electrically connected to the sensors, for monitoring glucose in diabetic patients, hypercholesterolemia patients cholesterol and lactate levels during urgent care events. Typically, a sensor has an elongated body comprising a working electrode, an insulating layer covering the working electrode, and a reference electrode applied to the insulating layer. [0003] The sensor includes two ends, one end is a sensing end containing an electroactive domain (such as an enzyme, an electronic mediator, etc.), which is used for implantation in the body. layer of biocompatible film; the other end is an e...

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Problems solved by technology

[0012] Usually, the puncture needle is made of hard metal. Although the necessary anti-corrosion treatment has been taken, the applicant found that in some extreme cases, the contact between the reference electrode on the outermost layer of the sensor and the inner wall of the puncture needle will occur similar to that of two different metals. Contact corrosion that occurs when they are in contact with each other. When the reference electrode contains chlorine, the corrosion phenomenon is particularly serious, and adhesion occurs, which will cause the sensor to be unable to stay in the body when the puncture needle is pulled out

[0013] Even if the sensor can be left in the body, corrosion on the electrodes, especially the reference electrode, can lead to poor electrical connections with electronic components outside the body

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