Device, system and method for monitoring an analyte concentration in a foetus

A system for monitoring a concentration of a lactate analyte in foetal tissue or foetal blood of a foetus, the system comprising:

• a) a device for continuously electrochemically measuring the concentration of the lactate analyte in the foetus, the device comprising:
• i. a biosensor for electrochemically measuring a concentration of a lactate analyte in the foetus, the biosensor comprising (A) a reactive substance on a working electrode, and (B) a counter current electrode, wherein the reactive substance of the biosensor comprises an immobilised enzyme to react with the analyte in the foetal tissue or foetal blood;
• ii. a protrusion in the form of a needle configured to be at least partially inserted into the foetal tissue, wherein the protrusion in the form of the needle comprises the reactive substance and functions as the working electrode of the biosensor;
• iii. an anchor for anchoring the device body to the foetal tissue, wherein the anchor forms a separate component to the protrusion in the form of the needle, wherein the anchor is in the form of a spiral;
• wherein the anchor surrounds and is not in physical contact with the protrusion in the form of the needle on account of a gap located radially between the anchor and the protrusion in the form of a needle;
• and
• iv. a device body supporting the biosensor comprising the protrusion in the form of the needle and the anchor, the device body being configured to contact a surface area of the foetal tissue;
• b) an analysis component in electronic communication with the working electrode and the counter current electrode of the biosensor, the analysis component being configured to determine information indicative of the concentration of the analyte using the detected electronic signal of the biosensor,
• wherein the system is configured such that when the device body contacts the surface area of the foetal tissue, the device body can be anchored to the contacted surface area of the foetal tissue via the anchor by rotating the device body and simultaneously the protrusion in the form of the needle comprising the reactive substance can be at least partially inserted into the tissue so that the reactive substance of the biosensor electrochemically reacts with the lactate analyte in the foetal tissue or foetal blood and in response to the electrochemical reaction at a surface of the protrusion in the form of a needle in its function as the working electrode the biosensor detects an electronic signal, a strength of the electronic signal being indicative of the concentration of the lactate analyte or the rate of the change of the concentration of the lactate analyte in the foetal tissue or foetal blood;
• and
• wherein the system is configured to monitor the concentration of the lactate analyte or rate of change in concentration of the lactate analyte continuously and in real-time.

A method of monitoring a concentration of a lactate analyte in foetal tissue or foetal blood of a foetus, the method comprising:

• a) providing a device for continuously electrochemically measuring the concentration of the lactate analyte in the foetus, the device comprising:
• i. a biosensor for electrochemically measuring a concentration of a lactate analyte in the foetus, the biosensor comprising (A) a reactive substance on a working electrode, and (B) a counter current electrode, wherein the reactive substance of the biosensor comprises an immobilised enzyme to react with an analyte in the foetal tissue or foetal blood;
• ii. a protrusion in the form of a needle configured to be at least partially inserted into the foetal tissue, wherein the protrusion in the form of the needle comprises the reactive substance and functions as the working electrode of the biosensor;
• iii. an anchor, wherein the anchor forms a separate component to the protrusion in the form of the needle, wherein the anchor is in the form of a spiral;
• wherein the anchor surrounds and is not in physical contact with the protrusion in the form of a needle on account of a gap located radially between the anchor and the protrusion in the form of the needle;
• and
• iv. a device body supporting the biosensor comprising the protrusion in the form of the needle and the anchor, the device body being configured to contact a surface area of the foetal tissue;
• and
• b) anchoring the device to the foetal tissue with the anchor by rotating the device body and simultaneously inserting the protrusion in the form of the needle at least partially into the foetal tissue;
• c) detecting an electronic signal at the working electrode of the biosensor, the electronic signal being in response to an electrochemical reaction between the reactive substance of the biosensor and the lactate analyte to be monitored;
• wherein the method is conducted such that the detected electronic signal is indicative of the concentration of the lactate analyte or a rate of change of concentration of the lactate analyte in the foetal tissue or foetal blood;
• and
• wherein the method monitors the concentration of the lactate analyte or the of the change in concentration of the lactate analyte continuously and in real-time.