Devices, systems, and methods for monitoring analyte concentration in a fetus

Abstract

The present invention relates to a device for monitoring a concentration of an analyte in a fetus. The device comprises a biosensor for electrochemically measuring the concentration of the analyte in the fetus, a protrusion configured to be at least partially inserted into a tissue of the fetus, and a device body supporting the biosensor and the protrusion. The device is configured such that, when the device body contacts a surface area of the tissue of the fetus, the device body can anchor to the tissue of the fetus and the protrusion can be at least partially inserted into the tissue such that a reaction substance of the biosensor electrochemically reacts with the analyte in the tissue of the fetus and, in response to the electrochemical reaction, an electrode of the biosensor detects an electronic signal, the strength of which is indicative of the concentration of the analyte.

Description

TECHNICAL FIELD

[0001] The present invention relates to devices, systems and methods for monitoring the concentration of an analyte in a fetus. In particular, the present invention relates to devices, systems and methods for monitoring the concentration of lactate in fetal tissue. BACKGROUND

[0002] During labor and delivery, the fetal brain, nervous system and other end organs are at risk of damage due to hypoxia, also known as fetal distress. Fetal distress can have long-lasting sequelae for babies and their families.

[0003] Currently, clinicians monitor uterine contractions and fetal heart rate (FHR) using a cardiotocograph (CTG), where changes in the signal pattern can be indicative of fetal distress. However, changes in the signal pattern are often only subjectively assessed, which leads to a high number of false positives. As a result, many caesarean section surgeries are performed based on false indications of fetal distress as a defensive measure to reduce the risk of intrapartum fetal distress. Due to the high number of false positives, the proportion of non-selective caesarean sections has increased. However, caesarean sections are associated with a number of problems. For example, caesarean sections are associated with an increased maternal morbidity, a prolonged recovery time and an increased rate of postpartum infections, to name a few. Furthermore, caesarean sections are more costly than vaginal deliveries.

[0004] Advantageously, at least one embodiment of the present invention provides a method of continuously and in real-time monitoring parameters related to fetal distress, or at least provides an alternative to conventional devices and methods.

[0005] Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.

[0006] Throughout this specification the word "comprise", and variations such as "comprising" or "comprises", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps. SUMMARY

[0007] Embodiments of the present invention relate to a device for monitoring the concentration of an analyte in a fetus, the device comprising:

[0008] a biosensor for electrochemically measuring the concentration of the analyte in the fetus, the biosensor comprising a reaction substance and an electrode,

[0009] a protrusion configured to be at least partially inserted into fetal tissue, the protrusion comprising at least a portion of the biosensor, and

[0010] a device body supporting the biosensor and the protrusion, the device body configured to contact a surface area of the fetal tissue;

[0011] wherein the device is configured such that when the device body contacts the surface area of the fetal tissue, the device body can anchor to the fetal tissue to secure to the contacted surface area of the fetal tissue and the protrusion can at least partially insert into the tissue such that the reactive species of the biosensor electrochemically reacts with the analyte in the fetal tissue and in response to the electrochemical reaction, the electrode of the biosensor detects an electronic signal, wherein the strength of the electronic signal is indicative of the concentration of the analyte or the rate of change of the concentration of the analyte.

[0012] Accordingly, embodiments of the present application enable real-time monitoring of the concentration of a selected analyte in a fetus. In this way, the oxygen metabolite and metabolites of the fetus can be examined in real-time, which can provide an indication of the health condition of the fetus during delivery and production. Furthermore, the process of electrochemically detecting the concentration of the analyte in the fetus can be less invasive to the fetus as it can not be necessary to extract a tissue or blood sample from the fetus.

[0013] For example, the fetal tissue can be located on the scalp of the fetus. However, it will be appreciated that the fetal tissue can be located at different body parts of the fetus, for example, if the fetus is in a breech position.

[0014] The protrusion can be in the form of a needle. For example, an outer surface area of the needle can be coated with the reactive species of the biosensor. The needle can also function as the electrode of the biosensor. Accordingly, by inserting the needle into the fetal tissue, the reactive species can electrochemically react with the analyte in the tissue. In this example, the biosensor can be configured to withstand a force when the needle is inserted into the biological tissue. Alternatively, the protrusion can be in the form of a rod or a wire.

[0015] In an embodiment, the needle can comprise a hollow space, wherein the biosensor is at least partially located within the hollow space. In a particular example, the needle comprises an opening within a sidewall or at a tip of the needle leading to the hollow space to expose the biosensor to an outer surface of the needle such that when the needle is inserted into the tissue, the reactive species can electrochemically react with the analyte in the fetal tissue at the opening. For example, the opening can be in the form of a slit or a cut.

[0016] In another example, the needle can comprise a hollow tubular space and the needle can be movable relative to the biosensor located within the hollow tubular space of the needle. Accordingly, when the needle and the biosensor are inserted together into the fetal tissue, the needle can be retracted while at least a portion of the biosensor remains within the fetal tissue. Furthermore, the needle can comprise an opening within a sidewall of the needle which forms a track for guiding the movement of the needle relative to the biosensor.

[0017] The needle can be made of any suitable material, including but not limited to stainless steel, biocompatible materials, biological materials, synthetic materials, and biodegradable materials. The length of the protrusion can be between 0.5 mm and 3 mm, or between 1 mm and 2.5 mm, or between 1.5 mm and 2.5 mm, or between 1 mm and 2 mm, or about 1 mm, 1.5 mm, or 2 mm.

[0018] In an embodiment, the protrusion can be configured to form an anchor for anchoring the device body to the fetal tissue. Alternatively, the device can comprise an anchor for anchoring the device body to the fetal tissue, wherein the anchor forms a separate component from the protrusion.

[0019] In the following, the term "anchor" can refer to any of the alternative embodiments described above.

[0020] In an embodiment, the anchor can be in the form of a screw or a hook, and the device can be configured such that the device body can be anchored to the fetal tissue by rotating the device body.

[0021] In a particular example, the anchor can be moved from a passive configuration to an active configuration to anchor the device to the fetal tissue. The anchor can be spring-loaded. In particular, the anchor can be coiled and configured to form a closed loop enclosing a portion of the fetal tissue to anchor the device body to the fetal tissue when the anchor is in the active configuration.

[0022] The device body can further comprise a layer of flexible material covering the surface area for contacting the fetal tissue. The surface area of the device body can be shaped to substantially conform to the shape of the fetal tissue.

[0023] In an embodiment, the device body can be substantially flat. This has the particular advantage that the device body fixed to the fetal scalp has a relatively low profile. Additionally or alternatively, the device body can be substantially dome-shaped, wherein the protrusion and / or the anchor is located at a substantially flat base of the dome-shaped device body. Alternatively, the device body can have a substantially cylindrical shape, wherein the protrusion and / or the anchor is located at a proximal end of the device body.

[0024] The device can further comprise a guiding element configured such that the device body can be guided through the vagina and the dilated cervix to position the device body against the fetal tissue. The guiding element can be attached to the device body. For example, the guiding element can comprise a tube having a hollow portion, and the device body can be positioned within the hollow portion of the guiding tube. In particular, the guiding element can comprise a base tube and a sleeve movable relative to the base tube, wherein the guiding element can be configured such that a space for holding the device body is formed between the base tube and the sleeve.

[0025] The device body can comprise at least one recess for receiving the protrusion and / or at least a portion of the anchor when the anchor is in the passive configuration. In this way, the protrusion and / or the anchor can be at least partially concealed when the device body is guided through the vagina and at least partially dilated cervix.

[0026] The protrusion comprising at least a portion of the biosensor can protrude from a substantially central point of a substantially planar surface area of the device body.

[0027] The anchor can be configured such that the device body is securely held against the fetal tissue when the anchor is inserted into the fetal tissue. In this way, the anchor can provide sufficient resistance to withstand forces exerted on the device during labor and delivery.

[0028] In an embodiment, the device can comprise an actuator for inserting the protrusion into the fetal tissue and / or anchoring the device body to the fetal tissue. The skilled person will appreciate that the device can comprise a plurality of actuators to control various components of the device. This can be particularly applicable if the anchor is a separate component from the protrusion. In an embodiment, the actuator can be configured to move the anchor from the passive configuration to the active configuration. The actuator can be in the form of a push or pull mechanism, a push-pull mechanism, a switch or a twist mechanism.

[0029] In an embodiment, the device can further comprise a component for monitoring heart rate. The component can comprise a fetal electrode for monitoring fetal heart rate. In addition, the component can comprise a maternal electrode for monitoring maternal heart rate. For example, the device can comprise a further protrusion configured to be inserted into the fetal tissue, wherein the further protrusion forms at least a portion of the fetal electrode for monitoring fetal heart rate. In a particular embodiment, the protrusion and the further protrusion can extend substantially parallel to each other, such as along a substantially straight direction or coiled. In an embodiment, the further protrusion can be in the form of a needle configured to be at least partially inserted into a tissue region of the fetus.

[0030] In an alternative embodiment, the protrusion comprising at least a portion of the biosensor can further comprise a fetal electrode for monitoring fetal heart rate. In this example, the device is configured such that the electrode of the biosensor and the fetal electrode are electrically insulated from each other. In another example, the anchor can comprise at least a portion of the fetal electrode for monitoring fetal heart rate. For example, the further electrode can be located at a tip of the anchor element, such as a curved or straight leg.

[0031] In an embodiment, the device is configured such that the biosensor can detect a concentration of an analyte in the fetal tissue, such as extracellular matrix. Additionally or alternatively, the device can be configured such that the biosensor can detect a concentration of an analyte in the fetal blood.

[0032] In a particular embodiment, the analyte to be monitored can be lactate. The fetal lactate concentration in fetal tissue and / or fetal blood can be monitored. However, other analytes are contemplated, including but not limited to glucose, Cortisol, pyruvate, Activin A, bicarbonate, hydrogen ion, non-protein bound iron, hypoxanthine, and other suitable analytes that can be indicative of fetal well-being.

[0033] In a particular embodiment, the device includes a plurality of biosensors to monitor concentrations of a plurality of analytes.

[0034] In an embodiment, the reactive species of the biosensor includes an immobilized enzyme. The biosensor can be coated with the immobilized enzyme. If the device is configured to monitor lactate concentration in the fetus, the immobilized enzyme can be, for example, lactate oxidase or lactate dehydrogenase. However, other suitable enzymes are contemplated. Those skilled in the art will appreciate that the species can be selected depending on the analyte to be monitored for which an electrochemical reaction occurs.

[0035] The device can also include an analysis component for analyzing the detected electronic signals. The analysis component can be part of a computing device including a processor. The processor can be configured to determine the absolute concentration of the analyte in the fetus. In an embodiment, the analysis component is configured to determine whether the concentration of the analyte exceeds or falls below a predetermined threshold.

[0036] The analysis component can be housed in an external housing and in electronic communication with the biosensor and / or another electrode for detecting fetal heart rate. For example, the analysis component can be connected to the biosensor and / or another electrode by a wire. The wire can extend through the guide tube.

[0037] The external housing can be attached to a body part of the mother. For example, the external housing can include a belt for connecting the analysis component to the mother's leg. However, other configurations are contemplated. For example, the device can include a wireless transmitter for transmitting the detected electronic signals to a computing device, such as a mobile computing device.

[0038] The device can be configured to monitor the concentration of the analyte in real time. For example, the device can be configured to monitor the concentration of the analyte continuously, periodically, or on request.

[0039] According to embodiments of the present invention, there is provided a system for monitoring a concentration of an analyte in a fetus, the system comprising:

[0040] a biosensor for electrochemically measuring the concentration of the analyte in the fetus, the biosensor comprising a reactive species and an electrode,

[0041] a protrusion configured to be at least partially inserted into fetal tissue, the protrusion comprising at least a portion of the biosensor,

[0042] a device body supporting the biosensor and the protrusion, the device body configured to contact a surface area of the fetal tissue, and

[0043] an analysis component in electronic communication with the electrode of the biosensor, the analysis component configured to use the detected electronic signal of the biosensor to determine information indicative of a concentration of the analyte,

[0044] wherein the system is configured such that when the protrusion can be at least partially inserted into the tissue, the device body can be anchored to the fetal tissue to be secured to the contact surface area of the fetal tissue, and such that the analyte electrochemically reacts with the reactive substance of the biosensor, and in response to the electrochemical reaction, the electrode of the biosensor detects an electronic signal, the strength of the electronic signal being indicative of the concentration of the analyte.

[0045] In an embodiment, the analysis component is configured to determine a trend of a baseline concentration of the analyte. The analysis component can be configured to determine whether the concentration of the analyte exceeds or falls below a predetermined threshold value.

[0046] In an embodiment, the analysis component can be configured to determine an absolute concentration of the analyte in the fetus.

[0047] The system can comprise a computing device comprising the analysis component, e.g. in the form of a processor. The computing device can further comprise a display for displaying information indicative of the concentration of the analyte in the fetus. The information can be displayed in real time.

[0048] The system can comprise an external housing for housing the analysis component. The external housing can comprise an attachment for connecting the external housing to a body part of the mother. For example, the external housing can comprise a belt for connecting the external housing to a leg or abdomen of the mother.

[0049] The analysis component can also be in electronic communication with a fetal electrode and / or a maternal electrode. The analysis component can be connected to the biosensor, the fetal electrode and / or the maternal electrode by a wire. The wire can extend through a guide tube of the device. Alternatively, the device can comprise a wireless transmitter for transmitting the detected electronic signal to a computing device, such as a mobile computing device.

[0050] According to an embodiment of the present invention, there is provided a method of monitoring a concentration of an analyte in a fetus, the method comprising:

[0051] providing a device for monitoring a concentration of an analyte in a fetus, the device configured to be anchored to fetal tissue and comprising a protrusion for at least partially inserting into the fetal tissue;

[0052] at least partially inserting the protrusion into the fetal tissue, the protrusion comprising at least a portion of a biosensor, the biosensor comprising a reactive substance and an electrode;

[0053] anchoring the device to the fetal tissue when the protrusion has been at least partially inserted into the fetal tissue; and

[0054] detecting an electronic signal at an electrode of the biosensor, the electronic signal being responsive to an electrochemical reaction between a reaction substance of the biosensor and the analyte to be monitored;

[0055] wherein the method is performed such that the detected electrical signal is indicative of the concentration of the analyte in the fetus.

[0056] In an embodiment, the protrusion is at least partially inserted into the fetal tissue such that the reaction substance can react with the analyte in the fetal tissue and / or fetal blood.

[0057] The method can comprise the step of guiding the device through the vagina and dilated cervix. In particular, the method can comprise the step of providing a guiding element comprising a base tube and a sleeve and positioning the device in a space formed between the base tube and the sleeve. When the protrusion has been inserted into the fetal tissue and the device body has been anchored to the fetal tissue, the method can comprise the step of removing the guiding element from the device.

[0058] The application will be more fully understood from the following description of specific embodiments of the application. The description is provided with reference to the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0059] Figure 1 is a schematic view of a system for monitoring the concentration of an analyte in a fetus according to an embodiment of the application;

[0060] Figure 2 is a schematic view of a system for monitoring the concentration of an analyte in a fetus according to another embodiment of the application;

[0061] Figures 3 to 5 different views of a device for monitoring the concentration of an analyte in a fetus according to an embodiment of the application are shown;

[0062] Figure 6 and 7 different views of a device for monitoring the concentration of an analyte in a fetus according to an embodiment of the application are shown;

[0063] Figures 8A to 8E different configurations of a device and a guiding tube according to an embodiment of the application are shown; Figure 6 and 7 different configurations of a device and a guiding tube according to an embodiment of the application are shown;

[0064] Figure 9 is a schematic view of a device for monitoring the concentration of an analyte in a fetus according to another embodiment of the application;

[0065] is a schematic view of a device for monitoring the concentration of an analyte in a fetus according to another embodiment of the application;Figure 10A and 10B different configurations of the device of Figure 9

[0066] Figure 11 shows a schematic diagram of an exemplary device for monitoring a concentration of an analyte in a fetus according to another embodiment of the present application;

[0067] Figure 12A and 12B different configurations of the device of Figure 11

[0068] Figure 13 shows a schematic diagram of a biosensor of an exemplary device of Figures 3 to 1 2; and

[0069] Figure 14 shows a flowchart of a method for monitoring a concentration of an analyte in a fetus according to an embodiment of the present application. DETAILED DESCRIPTION

[0070] Embodiments of the present application generally relate to devices, systems, and methods for monitoring a concentration of an analyte in a fetus. A device according to an embodiment of the present application includes a biosensor for electrochemically measuring a concentration of an analyte in a fetus, such as a lactate concentration in fetal tissue. The biosensor includes a reactive substance selected to react with the analyte to be monitored and an electrode for detecting an electronic signal. The device further includes a protrusion configured to be at least partially inserted into fetal tissue, wherein the protrusion includes at least a portion of the biosensor. For example, the protrusion can be in the form of a needle coated with the reactive substance of the biosensor. In this way, the reactive substance of the biosensor can be positioned within the fetal tissue. Alternatively, the protrusion can be in the form of a needle including a hollow space, wherein the biosensor is disposed within the hollow space. In this example, the exterior of the needle can be retractable so as to only position the biosensor within the fetal tissue, or the needle can have an opening so as to expose the biosensor to the exterior surface of the needle.

[0071] The device further includes a device body for supporting the biosensor and the protrusion. The device body generally has a relatively low profile and can be attached to a guide element so as to facilitate positioning of the device body on the fetal tissue through the vagina and a mother's fully dilated cervix.

[0072] ​​The device is configured such that the device body is anchorable to the fetal tissue, and the protrusion is at least partially inserted into the fetal tissue. In this regard, the protrusion can be configured as an anchor, or alternatively, the device can include an anchor that forms a separate component from the protrusion. Hereinafter, the term "anchor" can refer to a protrusion configured as an anchor or an anchor as a separate component. The anchor can include a coiled anchoring element, for example, in the form of a hook or a spiral that can anchor within the fetal tissue. Additionally or alternatively, the anchor can be movable from a passive configuration to an active configuration to anchor the device body in the fetal tissue. The anchor can also be movable from the active configuration to the passive configuration to remove the device body from the fetal tissue once monitoring of the analyte is completed.

[0073] The device is configured such that when the protrusion is at least partially inserted into the tissue, the reaction substance of the biosensor electrochemically reacts with the analyte such that, in response to the electrochemical reaction, the electrode of the biosensor detects an electronic signal. The strength of the electronic signal is indicative of the concentration of the analyte or the rate of change of the concentration of the analyte. In some embodiments, the device further includes components for monitoring heart rate, such as a fetal electrode for monitoring fetal heart rate and a maternal electrode for monitoring maternal heart rate.

[0074] In accordance with the detailed description of exemplary embodiments of the present invention, the embodiments of the present invention have significant advantages that will become more apparent.

[0075] As described in the background section, conventional methods of monitoring fetal health through heart rate monitoring result in false positive indications of fetal distress that can lead to an increase in caesarean sections to shorten delivery time. One method of monitoring fetal health involves taking a sample of fetal blood to determine fetal blood lactate levels. Lactate is a metabolite produced during glucose metabolism when oxygen is scarce. The fetal blood sample is typically taken from the fetal scalp or umbilical artery at the time of delivery. The sample is then analyzed for lactate concentration, which is produced when the fetus is hypoxic and undergoes anaerobic respiration. However, this method has many drawbacks. For example, the method is relatively invasive to the fetus and the mother. Due to its complexity, it is difficult to perform, resulting in an average time of about 20 minutes. However, the method typically takes longer, which can be painful, uncomfortable, and degrading for the woman and her physician. More importantly, this complex procedure can result in complications such as hematoma, scalp bleeding, and death.

[0076] Embodiments of the present invention aim to reduce complexity and invasiveness. Furthermore, at least one embodiment of the present invention is capable of monitoring a selected analyte, such as lactate, continuously and in real-time. Thus, once the lactate level exceeds a predetermined threshold, the physician or midwife can take immediate action.

[0077] Furthermore, by using an electrochemical reaction between the biosensor and the analyte to be monitored, it can not be necessary to collect a blood or tissue sample. This is different from conventional methods and other methods, such as microdialysis.

[0078] Reference is now made to the drawings, Figure 1 A system 100 for monitoring the concentration of an analyte in a fetus is shown. The system 100 comprises a device 102 to be fixed to a tissue of the fetus, in this example to the scalp 104 of the fetus. The person skilled in the art will understand that the device 102 can be attached to a different body part of the fetus, for example if the fetus is in a breech position. The device 102 is in electronic communication with an analysis component 106 by a wire 108. The analysis component 106 is typically a computing device comprising a processor, in this example housed in an external housing 106 with a display 107 to display information indicative of the lactate concentration. The external housing 106 has a belt 110 for attaching the analysis component 106 to the mother. In this example, the analysis component 106 is attached to the leg of the mother. However, the analysis component 106 can alternatively be attached to the abdomen of the mother or any other suitable body part. Attaching the analysis component 106 to the leg of the mother has the advantage that the length of the wire 108 can be kept relatively short and allows the mother to move freely around, walk and shower.

[0079] The device 102 comprises at least a biosensor for sensing the concentration of the analyte, in this particular example the lactate concentration. The lactate concentration is typically sensed in the tissue of the fetus, but can also be sensed in the blood of the fetus. In the following examples, the device 102 further comprises a fetal electrode for detecting the fetal heart rate and a maternal electrode for detecting the maternal heart rate, which will be described in further detail below. However, the person skilled in the art will understand that other methods can be used to detect the heart rate of the fetus and / or the mother.

[0080] The device 102 is positioned at the fetal scalp through the vagina 112 and a sufficiently dilated cervix 114. This can be achieved by attaching the device 102 to a guiding element, such as a guiding tube. If the width of the device 102 is between 0.3 and 4 cm, the device 102 can be positioned at the fetal scalp in the early stages of the mother’s dilation ranging from 2 to 4 cm.

[0081] Figure 2An alternative exemplary system 200 according to an embodiment of the application is shown. In this example, like numerals refer to like parts of system 200. System 200 also includes a device 102 that can be attached to the fetal scalp 104. In this example, device 102 is in electronic communication with an external monitoring device 202 that can be located on a bedside table 204. In this example, external monitoring device 202 is connected to device 102 via a wire 108. However, those skilled in the art will appreciate that device 102 can be wirelessly connected to external monitoring device 202. In this case, device 102 can include a transmitter for wirelessly transmitting electronic signals to a computing device. The computing device can be external monitoring device 202, but can alternatively be a smartphone, tablet, laptop, or personal computer.

[0082] External monitoring device 202 includes a display 206 for displaying information indicative of the concentration of the analyte. The information can be in any suitable form. For example, the absolute concentration of the analyte can be displayed in numbers or a graph. Additionally or alternatively, a trend in the baseline concentration can be displayed. In this way, a physician or midwife can be able to monitor the concentration of the analyte continuously and in real time. Thus, if the information indicative of the lactate concentration exceeds or falls below a predetermined threshold, the physician or midwife is able to intervene immediately.

[0083] Reference is now made to Figures 3 to 5 , showing a device 300 for monitoring the concentration of an analyte according to a first embodiment of the application. In this example, device 300 is configured to monitor the concentration of lactate. Device 300 can be, for example, device 102 that is part of system 100 or system 200 as shown in Figure 1 and 2 .

[0084] Device 300 includes a device body 302 that can be positioned against a surface area of fetal tissue, such as the fetal scalp. In this particular example, device body 302 is substantially dome-shaped, having a substantially planar surface area facing the fetal tissue and a circular portion configured to face away from the fetal tissue. Thus, device 300 has a relatively low profile, which is advantageous when the device 300 is in use. An exemplary height of the device body can be in the range of about 2 to 20 mm, or 2 to 15 mm, or 5 to 15 mm, or 5 to 10 mm, or about 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm. As described below, when device 300 is secured to the fetal tissue, the substantially planar surface area of device body 302 can be firmly pressed against a surface area of the fetal tissue to withstand forces exerted on device 102 during labor. The device body can also include a layer of flexible material (not shown) covering the substantially planar surface area for contacting the fetal tissue. Additionally or alternatively, the surface area can be shaped to substantially conform to the shape of the fetal scalp.

[0085] Those skilled in the art will appreciate that the device body can have any suitable shape. For example, the device body can have a substantially cylindrical shape with the protrusion and anchor located at the proximal end of the device body, for example as shown in the embodiments of Figure 11 and 12. In alternative embodiments, the device body can be substantially flat, as shown in the embodiments of Figure 9 and 10. In another example, the device body 302 can be substantially flat and attachable to a guide tube, as shown in the embodiments of Figure 6

[0086] Returning to the device 300, the device body 302 supports a first protrusion 304, which can be inserted at least partially into fetal tissue, such as fetal scalp 104. In this example, the first protrusion 304 is in the form of a relatively short first needle 304 of about 2 mm in length. The needle 304 is configured to be inserted fully into the fetal scalp. In this example, the needle 304 is made of steel. However, other suitable materials are envisaged, including but not limited to biocompatible materials, biological materials, synthetic materials, and biodegradable materials. The needle 304 can have any suitable length, including but not limited to between 0.5 mm and 3 mm, or between 1 mm and 2.5 mm, or between 1.5 mm and 2.5 mm, or between 1 mm and 2 mm, or about 1 mm, 1.5 mm, or 2 mm.

[0087] The first needle 304 is part of a biosensor 306, which is configured to electrochemically measure the concentration of lactate in the fetal tissue. In this regard, the biosensor 306 includes a reactant and an electrode. Figure 13 A more detailed representation of the biosensor 306 is shown. An electrochemical biosensor generally includes two elements, a biological element that reacts with the analyte to be monitored and a transducer element. The interaction between the biological element and the analyte can produce an electrical, optical, or thermal signal that can be detected by the transducer element and converted into a measurable electrical parameter. In this example, the biosensor 306 utilizes a three-electrode system including a working electrode 502, a reference electrode 504, and a counter electrode. The working electrode 502 has a first end 508 forming the first needle 304, which is coated with a reactant (not shown), in this case an immobilized enzyme such as lactate oxidase or lactate dehydrogenase. The biosensor 306 is configured to measure the current between the working electrode 502 and the counter electrode, and utilizes the principle that the measured current is proportional to the concentration of lactate in the fetal tissue. The reference electrode 504 can be an Ag / AgCl or saturated calomel electrode, which provides a stable and reproducible potential compared to the working electrode potential.

[0088] ​When the first end 508, which is coated with immobilized enzyme, is inserted into the fetal tissue, the immobilized enzyme reacts with the lactate concentration present in the extracellular matrix and the dense connective tissue of the skin blood and fetal scalp. The enzymatic reaction leads to the formation of a peroxide ion, which is electrochemically detected as a chemical reduction event at the working electrode 502 of the biosensor 306. This results in the transmission of an electronic signal, which is transmitted via the wire 312 to an analysis component, such as the analysis component 106. The electronic signal can undergo signal conversion to obtain information indicative of the lactate concentration in the fetus.

[0089] The concentration of lactate is correlated to the strength of the electronic signal. With this correlation, it is possible to determine the absolute value of the lactate concentration in the fetal tissue. However, it is sufficient to determine the trend relative to the baseline concentration and / or whether the electronic signal exceeds or falls below a predetermined threshold based on historical data. In order to determine the absolute value of the lactate concentration in the fetus, it can be necessary to perform a calibration method. In this regard, a blood sample of the fetus can be taken and examined to determine a reference concentration. Considering exemplary values for the absolute concentration of lactate in the fetal tissue, it can be considered that the normal range is less than 4.1 mmol / L, whereas the pre-acidosis range can be defined as a lactate concentration between 4.2 and 4.8 mmol / L, and the acidosis range can be higher than 4.8 mmol / L.

[0090] Referring back to Figures 3 to 5 , the device 300 comprises a second protrusion 308 in the form of a second needle 308. The second needle 308 is part of a fetal electrode 310 for detecting the fetal heart rate. Although the fetal electrode 310 comprises a needle in this example, the skilled person will understand that other implementations can be envisaged. For example, the fetal electrode can be in the form of a plate configured to contact the fetal tissue to detect the fetal heart rate. In addition to the fetal electrode 310, the device 300 comprises a maternal electrode 311 for detecting the maternal heart rate. The maternal electrode 311 is configured to contact the tissue of the mother, such as the uterus, to monitor the heart rate.

[0091] In this particular example, the electrodes of the biosensor 306 and the fetal heart rate monitor 310, 311 are implemented as having independent needle components. However, the skilled person will understand that the electrodes can be combined into one component, as long as the electrodes are electrically isolated from each other. Furthermore, the fetal electrode 310 and / or the biosensor 306 can be incorporated in other components of the device 300, such as in the anchoring element or the surface element of the device body 302, which will be described in the embodiments shown in Figure 9 and 10.

[0092] Further, those skilled in the art will appreciate that the device 300 can include additional sensors, which can be incorporated in additional or existing components, such as the protrusions. For example, the device can include multiple biosensors to monitor multiple analytes, including but not limited to glucose, Cortisol, pyruvate, Activin A, bicarbonate, hydrogen ion, non-protein bound iron, hypoxanthine, and other suitable analytes that can be indicative of fetal health.

[0093] The electrodes of the fetal electrode 310, the maternal electrode 311, and the biosensor 306 are electrically connected to the external analysis component by wires 314, 312. In this example, the wires 314, 312 have a further function of facilitating activation of the anchoring elements of the device 300, as described below.

[0094] The device 300 includes an anchor 316, which includes anchoring elements 318 for holding the device body 302 in place when the first and second needles 304, 308 have been inserted into the fetal tissue. In this example, the anchor 316 includes four anchoring elements 318 in the form of hooks 318. The anchor 316 can be moved from a passive configuration to an active configuration, and vice versa. In this regard, the device body 302 includes a plurality of recesses 320 that are sized and shaped to receive the respective hooks 318 when the anchor 316 is in the passive configuration. In this example, the recesses 320 are in the form of slits arranged in a cross format. However, other configurations are envisaged.

[0095] When the anchor 316 is in the passive configuration, the four hooks 318 are located within the respective recesses 320. In this way, the hooks 318 can be avoided from interacting with the surrounding tissue when the device 300 is guided through the vagina and the sufficiently dilated cervix. Once the device body 302 is positioned against the fetal tissue, the anchor 316 is moved to the active configuration, and the hooks 318 are pivoted towards each other about the pivot axes 322. The device body 302 includes respective pins 324 about which the hooks 318 are pivoted. As a result, the ends of the hooks 318 move out of the recesses 320 and into the fetal tissue. In this way, the device body 302 can be anchored to the fetal tissue. Once the hooks 318 are inserted into the fetal tissue, the device body 302 is securely held against the fetal tissue. In this way, the anchor 316 can provide sufficient resistance to withstand the forces exerted on the device 300 during the delivery and production of the fetus.

[0096] Those skilled in the art will appreciate that the anchor can have any suitable anchoring element configured to secure the device body 302 to the fetal tissue. For example, the anchor can comprise any suitable number of legs that can be inserted into the fetal tissue. The legs can be bent to form hooks, or be substantially straight. The legs can comprise an end portion with barbs. In an alternative example (not shown), the anchoring element can be in the form of a plurality of substantially straight legs entering the fetal tissue at different angles to secure the device body 302 to the fetal tissue. In particular, the plurality of substantially straight legs can fan out such that the distance between adjacent legs increases with depth in the fetal tissue.

[0097] To move the anchor 316 from the passive configuration to the active configuration, the device 300 comprises an activator. In this particular example, the activator is in the form of a push-pull mechanism and comprises a cylinder 326 located within the central passage 328 of the device body 302. The cylinder 326 has two opposite ends, one of which is connected to the hook 318 by a drive axis 329. To this end, the cylinder 326 comprises a respective drive pin 330. The other distal end of the cylinder 326 is connected to the first and second lines 312, 314, for example by a carabiner connection 332.

[0098] The device 300 is configured such that the cylinder 326 can move laterally within the central passage 328 of the device body 302 to cause the hook 318 to pivot about the respective pivot axis 326. In this way, the anchor 316 can be moved from the passive configuration to the active configuration and vice versa. Thus, by pulling the lines 312, 314, the anchor 316 can be moved from the passive configuration to the active configuration. By pushing the lines 312, 314 towards the device body 302, the anchor 316 returns from the active configuration to the passive configuration and the hook 318 is removed from the fetal tissue.

[0099] In this particular example, the device 300 further comprises a locking element for locking the anchor 316 in the passive configuration or in the active configuration. The locking element comprises a ball bearing 334 and a spring 336. The cylinder 326 comprises a locking stop in the form of a recess located on the side of the cylinder 326. This is shown in particular in the side view of the device 300. Figure 5 The ball bearing 334 and the spring 336 are held in place by a plug 338 such that the spring 336 pushes the ball bearing 334 against the side of the cylinder 326.

[0100] Reference is now made to Figure 6 and 7FIG. 4 shows the device 300 attached to a guide tube 400. The guide tube 400 can form a portion of the device 300. In this particular example, the guide tube 400 has a generally substantially cylindrical shape and is configured to guide the device body 302 through the vagina and a sufficiently dilated cervix to position the device body 302 against the fetal tissue. The diameter of the guide tube 400 can be similar to the width of the device body 302, i.e., in the range of about 2 and 4 cm, or about 2 cm, 3 cm, or 4 cm. The length of the guide tube 400 can be in the following ranges: about 5 and 35 cm, 10 and 30 cm, 15 and 25 cm, or 15 to 20 cm, or about 10 cm, 15 cm, 20 cm, or 25 cm.

[0101] In this example, the guide tube 400 includes a base tube 402 having a hollow passage through which the wires 312, 314 extend. The guide tube 400 also includes a hollow sleeve 404 that covers the end of the base tube 402. The guide tube 400 is configured such that a space is formed between the base tube 402 and the sleeve 404 to hold the device body 302. To position the device body 302 against the fetal tissue, the device body 302 is initially positioned in the space formed between the base tube 402 and the sleeve 404. This particular configuration is shown in Figure 8A FIG. 5. As shown, in this initial configuration, the hooks 318 are positioned in the recesses 320 of the device body 302 such that the hooks 318 cannot engage with surrounding tissue as the guide tube 400 is moved through the vagina and cervix.

[0102] Once the device body 302 is positioned against the fetal tissue, e.g., by pressing the guide tube 400 against the tissue, a user such as a physician or midwife can pull the wires 312, 314 to release the hooks 318 and anchor the device body 302 in the fetal tissue. Figure 8B and 8C FIG. 6 shows an exemplary configuration of the device 300 and the guide tube 400 during this process. Once the device body 302 is anchored in the fetal tissue, the guide tube 400 can be removed. In particular, the physician or midwife can pull the base tube 402 and the sleeve 404 together to remove the guide tube 400. By removing the guide tube 400, the comfort of the mother can be significantly improved and the mother can be allowed to move freely about.

[0103] Referring now to Figure 9 and 10, a device 500 for monitoring an analyte concentration is shown according to another embodiment of the present application. Similar to the device 300, the device 500 in this example is configured to monitor lactate concentration in a fetus and can be a device 102 that is part of the system 100 or the system 200 shown as Figure 1 and 2 FIG. 11. The device 500 includes a base tube 502 having a hollow passage through which a wire 514 extends. The device 500 also includes a hollow sleeve 504 that covers the end of the base tube 502. The device 500 is configured such that a space is formed between the base tube 502 and the sleeve 504 to hold a device body 506. To position the device body 506 against the fetal tissue, the device body 506 is initially positioned in the space formed between the base tube 502 and the sleeve 504. This particular configuration is shown in

[0104] Device 500 includes a device body 502 having a generally flat surface area for contacting fetal tissue and an opposing surface area for engagement with the fingers of a doctor or midwife. In this particular example, the device body 502 is approximately the size of an adult fingertip and is typically connected to an actuator for anchoring the device body 502 to the fetal tissue. In this particular embodiment, device 500 includes a first actuator 520 and a second actuator 522, which will be described in further detail below.

[0105] In this example, the device body 502 includes a structure 504 to identify surface areas for engagement with a probe from a doctor or midwife, thereby also identifying opposing surface areas that will come into contact with fetal tissue. This may help reduce the risk of the device body 502 becoming anchored to the doctor's or midwife's finger. Those skilled in the art will understand that the device body 502 may alternatively include patterns or the like to identify one of the opposing surface areas.

[0106] In another embodiment (not shown), the device body 502 may include an attachment structure for removably attaching the device body 502 to the fingertip of a doctor or midwife. This attachment structure can improve the process of guiding and placing the device body 502 against fetal tissue. For example, the structure may be in the form of a band, loop, or flange.

[0107] Return to reference Figure 9 As shown in the example in 10, device 500 also includes a first protrusion in the form of a first coiled needle 506 and a second protrusion in the form of a second coiled needle 508. The first coiled needle 506 forms a biosensor for electrochemically measuring the concentration of an analyte in the fetus. This biosensor includes a reactant selected to react with the analyte in the fetal tissue and electrodes for detecting an electronic signal generated in response to the electrochemical reaction. Specifically, similar to... Figures 3 to 5 In the illustrated embodiment, the biosensor is in the form of a solid needle, for example, made of hardened Pt or a Pt / Ir alloy coated with or containing a reactive material. (See above reference) Figures 3 to 5 Examples of non-exhaustive reactants and electrochemical reactions are discussed. In this embodiment, the biosensor is configured to have properties similar to a medical needle in order to withstand the force applied when the first needle 506 is inserted into fetal tissue, such as the fetal scalp.

[0108] The second coiled needle 508 forms a fetal electrode for detecting fetal heart rate. Those skilled in the art will understand that fetal electrodes for detecting heart rate are well-known in the art and will not be described in further detail. Examples of well-known fetal electrodes that can be inserted into fetal tissue include the Rocket Copeland fetal scalp electrode. While the exemplary device 500 includes first and second coiled needles 506, 508, those skilled in the art will understand that device 500 may include only a first protrusion forming a biosensor, and a separate device may be used to detect fetal heart rate (if any).

[0109] The first and second coiled needles 506, 508 are further configured to form corresponding anchoring elements for anchoring the device body 502 to fetal tissue. Each needle 506, 508 can be selectively moved between a passive configuration and an active configuration, and vice versa, by using corresponding actuators 520, 522 connected to the needles 506, 508 via lines 524, 526. However, those skilled in the art will understand that both needles 506, 508 can move simultaneously by using a single actuator. Each or both of the lines 524, 526 can be further used to transmit measured signals at the electrodes of the biosensor for further analysis.

[0110] The device body 502 includes a first cavity 510 and a second cavity 512, which are arranged such that the first and second needles 506 and 508 can be retracted and fully accommodated in the corresponding cavities 510 and 512 of the device body 502. Figure 10A The device 500 is shown, wherein the first needle 506 is fully retracted and positioned within the first cavity 510 (passive configuration), and the second needle 508 is in an active configuration and forms a closed loop with the device body 502. Figure 10B The device 500 is shown when the first needle 506 has been moved from a passive configuration to an active configuration, also forming a closed loop with the device body 502. Therefore, when the first and second needles 506, 508 retract into their respective cavities 510, 512, the needle / anchor elements 506, 508 are in a passive configuration, and the device body 502 can be positioned flush with the fetal tissue without inserting the first and second needles 506, 508 into the fetal tissue. The first and second needles 506, 508 can be moved from a passive configuration to an active configuration, whereby the tips of the needles 506, 508 are inserted into the fetal tissue. Once the first and second needles 506, 508 are positioned in the active configuration, each of the first and second needles 506, 508 forms a closed loop with the device body 502, which surrounds a portion of the fetal tissue, thereby anchoring the device body 502 to the fetal tissue.

[0111] In this particular example, each of the first and second needles 506, 508 are spring loaded, and the first and second needles 506, 508 form a closed loop active configuration with the device body 502 defining a default configuration. In other words, the actuator 520, 522 needs to be operated to actively move the coiled first and second needles 506, 508 into the cavities 510, 512. In this way, the risk of inadvertently anchoring the device 500 can be reduced.

[0112] In an alternative embodiment (not shown), the reaction portion of the biosensor is located within the core portion of the needle. The needle may, for example, include a hollow space within which a portion of the biosensor is located. In this regard, the needle can include an opening in the sidewall, such as a slit or cut, where the chemical reaction portion is exposed to the outer surface. In this way, once the needle is inserted into the biological tissue, the exposed portion of the biosensor can undergo an electrochemical reaction with the analyte in the fetal tissue. The advantage of this embodiment is that the needle itself can be constructed from a material with high mechanical strength, such as stainless steel, without the need for a chemically reactive material component. More importantly, the reaction portion of the biosensor can be made from a material that can not necessarily be able to withstand the force of inserting the device into the fetal tissue.

[0113] Reference is now made to Figure 11 and 12, showing a device 600 for monitoring an analyte concentration according to another embodiment of the present application. Similar to the devices 300 and 500, the device 600 is configured to monitor lactate concentration in a fetus, and can be a part of the system 100 or system 200 shown as device 102. In this particular embodiment, the cannula is configured for implementing the device 600, which will be described in further detail below. Figure 1 and 2 the system 100 or system 200. In this particular embodiment, the cannula is configured for implementing the device 600, which will be described in further detail below.

[0114] The device 600 includes a device body 602 having a shaft 604 for guiding the device 600 through the vaginal canal and at least partially dilated cervix. The device 600 includes a first needle 608 having a hollow tubular space, wherein a biosensor 610 is located within the tubular space of the needle 608. Similar to the cannula system, the first needle 608 is movable relative to the biosensor 610 located within the hollow space in order to place the chemical reaction portion of the biosensor 610 into the fetal tissue, while the needle 608 can be retracted. In order to describe this process in more detail, we now refer to Figures 12A to 12C which shows different configurations of the device 600 for positioning the biosensor 610 in the fetal tissue. First referring to Figure 12A , the needle 608 and biosensor 610 are shown in a passive retracted configuration. In this configuration, the device 600 can be moved through the vaginal canal and at least partially dilated cervix, and positioned against a surface area of the fetal tissue. Figure 12B the needle 608 and biosensor 610 are shown inserted into the fetal tissue,Figure 12C It is shown that when the biosensor 610 remains within the fetal tissue, the needle 608 is retracted, wherein the reactive substance of the biosensor 610 can react with the analyte of the tissue.

[0115] The device 600 further comprises an actuator for inserting the needle 608 and the biosensor 610 together into the fetal tissue. In this example, the actuator comprises a button (not shown) arranged at the distal end of the device 600, an inner shaft 612 connected to the button and a spring 614. When the actuator is operated by pressing the button, the inner shaft 612 translates this movement and engages with the base 618 of the needle 608. In this way, when the spring 614 of the actuator is compressed, the needle 608 and the biosensor 610 are moved together into the fetal tissue, in particular as shown in Figure 12B .

[0116] Once the button of the actuator is released, the spring 614 expands and the needle 608 is retracted into the housing of the device body 602, while the biosensor 610 remains within the fetal tissue, in particular as shown in Figure 12C . In order to lock the biosensor 610 in place within the fetal tissue, the device 600 further comprises a locking element 616. Once the biosensor 610 is positioned within the fetal tissue, the locking element 616 has the function of locking the biosensor 610 in place, while the needle 608 returns to its retracted configuration. The locking element 616 is connected to the biosensor 610 and is configured such that, when the biosensor 610 has been inserted into the fetal tissue, a flange 620 of the locking element 616 engages with a receptacle 622 inside the device body 602, thereby locking the biosensor in place, in particular as shown in Figure 12B and 12C .

[0117] The device 600 further comprises an anchor 624 for anchoring the device body 602 to the surface area of the biological tissue. The anchor 624 in this example forms a separate component from the needle 608. In particular, the anchor 624 is in the form of a spiral, which is insertable into the fetal tissue by rotating the device body 602. In this example, the anchor 624 also serves as an electrode for detecting the fetal heart rate. Electrodes for detecting the fetal heart rate are well known in the art and are therefore not described in detail. The person skilled in the art will understand that the anchor 624 of the device 600 can be shaped and dimensioned in any suitable way. For example, similar to the embodiments described with reference to Figure 9 and 10, instead of a spiral, the anchor 624 can be coiled and can be moved from a passive configuration to an active configuration.

[0118] In another embodiment (not shown), the device has a needle and a biosensor which are separate components, similar to the embodiments described with reference to Figure 11The configuration is similar to that of the device 600 shown in Figure 12. However, instead of a needle having a hollow tubular space in which a biosensor is disposed, the needle 608 is formed, for example, as shown in the figure. Figure 9 The biosensor described in device 500 shown in Figure 10. In this particular embodiment, the actuator of the device can be simplified because the spring 614 and locking element 616 may not be necessary, and the needle is held within the fetal tissue while monitoring the fetal analytes.

[0119] In another embodiment (not shown), the device has the same Figure 11 The configuration is similar to that of device 600 shown in Figure 12. However, instead of locking element 616, biosensor 610 includes a hook configured to anchor the biosensor within fetal tissue. Thus, once the biosensor and needle are inserted into the fetal tissue, the biosensor automatically hooks itself onto the fetal tissue to remain there as the needle retracts.

[0120] In another embodiment (not shown), the device has a configuration similar to that of device 500. However, as described with reference to device 600, the first needle is configured as a cannula system. Specifically, the device includes a substantially flat device body having cavities for receiving coiled first and second needles. The first and second needles are configured to selectively move between a passive configuration and an active configuration. In the passive configuration, the first and / or second needle retracts and is fully received within the respective cavities of the device body. In the active configuration, the first and / or second needle forms a closed loop with a surface region of the device body. When the device is anchored to biological tissue, the closed loop surrounds a portion of the biological tissue, thereby anchoring the device to the biological tissue. Regarding the key difference from device 500, the first needle of this exemplary device includes a hollow tubular space for receiving a biosensor, similar to the first needle of device 600. When the first needle moves from the passive configuration to the active configuration, the first needle, along with the biosensor, is inserted into the biological tissue. The first needle then retracts into the respective cavity of the device body, while a portion of the biosensor remains within the biological tissue in a coiled configuration.

[0121] Now for reference Figure 14A flow chart illustrating an exemplary method 700 of monitoring a concentration of an analyte in a fetus is shown. The method 700 comprises a step 702 of providing a device for monitoring a concentration of an analyte in a fetus. The device can for example be the device 300, 500 or 600 shown in the accompanying drawings. The device comprises a protrusion, such as a needle, for at least partial insertion into a fetal tissue, such as a fetal scalp. The device further comprises a device body for contacting a surface area of the fetal tissue. In a further step 704, the protrusion is at least partially inserted into the fetal tissue, wherein the protrusion is part of a biosensor having an electrode and a chemical reaction substance. The substance is typically chosen to react with the analyte to be monitored. For example, if the analyte is lactate, the reaction substance can be for example lactate oxidase or lactate dehydrogenase. The method further comprises a step 706 of anchoring the device body to the fetal tissue, for example by moving an anchor of the device from a passive configuration to an active configuration to at least partially insert an anchoring element of the anchor into the fetal tissue. The skilled person will appreciate that the step of anchoring the device body can be performed before, after or simultaneously with the insertion of the protrusion into the fetal tissue. The protrusion can for example be configured to form the anchor, such as a hook, a spiral or a clamp, to anchor the device body to the fetal tissue. In a further step 708, an electronic signal, such as an electric current, is detected at the electrode of the biosensor, wherein the electronic signal is indicative of the concentration of the analyte. The electronic signal is detected in response to an electrochemical reaction between the reaction substance of the biosensor and the analyte to be monitored in the fetus.

[0122] The device can comprise a guide tube that protects the protrusion and the anchor from engagement with surrounding tissue when the device is guided through the vagina and cervix. In this way, once the device is anchored to the fetal tissue, the guide tube can be removed and only the wiring, if any, connecting the device body and the external analysis component is kept in place, which reduces discomfort for the mother.

[0123] The method can further comprise a step of removing the device body from the fetal tissue. In this regard, the anchor can be moved from the active configuration to the passive configuration, which can automatically release the protrusion from the fetal tissue. However, it will be appreciated that the protrusion can be retractable and the method can comprise a step of retracting the protrusion before moving the anchoring element.

[0124] The device can be used in conjunction with a Doppler ultrasound device conventionally used to monitor the progress of labor and the health of the mother as well as an external CTG monitoring device to monitor the fetal heartbeat. In case the external monitoring causes difficulties or uncertainties, or leads to abnormal patterns, the device for monitoring the concentration of the analyte can be used.

[0125] Those skilled in the art will appreciate that the foregoing examples are illustrative and not limiting of the general inventive principles described herein. Numerous variations and / or modifications to these examples can be made by those skilled in the art without departing from the general principles of the present disclosure. Therefore, it should be apparent that the present embodiments can be embodied in a variety of forms other than those specifically set forth herein without departing from the spirit and essential characteristics of the disclosure.

Claims

1. A device for monitoring the concentration of lactate analytes in a fetus, the device comprising: i. A biosensor for continuous electrochemical measurement of the concentration of lactate analytes in fetus, the biosensor comprising (A) a reactant on a working electrode and (B) a countercurrent electrode, wherein the reactant of the biosensor comprises an immobilized enzyme to react with the analyte in fetal tissue or fetal blood; ii. A needle-shaped protrusion configured to be at least partially inserted into fetal tissue, the needle-shaped protrusion comprising at least a portion of a biosensor, wherein the needle-shaped protrusion comprises a reactive substance and functions as a working electrode of the biosensor; iii. An anchoring member for anchoring a device body to fetal tissue, wherein the anchoring member forms a component separate from the needle-shaped protrusion, wherein the anchoring member is in a helical form, and the device can be anchored to the fetal tissue by rotating the device body; and iv. A device body supporting a biosensor comprising needle-shaped protrusions and anchors, the device body being configured to contact a surface area of ​​fetal tissue; The device is configured such that when the device body contacts the surface area of ​​fetal tissue, the device body can be anchored to the contact surface area of ​​the fetal tissue via the anchoring element, and simultaneously the needle-shaped protrusion including the reactive substance can be at least partially inserted into the tissue, causing the reactive substance of the biosensor to undergo an electrochemical reaction with lactate analytes in the fetal tissue or fetal blood. In response to the electrochemical reaction at the surface of the needle-shaped protrusion acting as a working electrode, the electrode of the biosensor detects an electronic signal, the intensity of which indicates the concentration of lactate analytes or the rate of change of lactate concentration in the fetal tissue or fetal blood. The device is configured to continuously and in real time monitor the concentration of the lactic acid analyte or the rate of change of the lactic acid analyte concentration.

2. The device according to claim 1, further comprising another electrode for detecting the heart rate of the fetus.

3. The apparatus according to claim 2, wherein, The device includes a protrusion configured to be inserted into fetal tissue, wherein the protrusion forms part of an electrode for detecting the fetal heart rate.

4. The apparatus according to any one of claims 1 to 3, wherein, The device includes a mother electrode for detecting and capturing a reference signal.

5. The apparatus according to any one of claims 1 to 3, wherein, a) The outer surface region of the needle-shaped protrusion is coated with the reactive material of the biosensor, and the needle serves as the working electrode of the biosensor; or (b) The needle-shaped protrusion includes a hollow space, and the reactive material of the biosensor is at least partially located within the hollow space of the needle-shaped protrusion, wherein the needle-shaped protrusion includes an opening leading to the hollow space to expose the reactive material of the biosensor to the outer surface of the needle-shaped protrusion, such that when the needle-shaped protrusion is inserted into tissue, the reactive material of the biosensor can electrochemically react with the analyte in the fetal tissue at the opening and the needle-shaped protrusion acts as a working electrode of the biosensor.

6. The apparatus according to any one of claims 1 to 3, wherein, The anchor is coiled and can be moved from a passive configuration to an active configuration to anchor the device body to fetal tissue.

7. The apparatus according to claim 6, wherein, The anchoring element is configured to form a closed loop that encloses part of the fetal tissue, thereby anchoring the device body to the fetal tissue.

8. The apparatus according to claim 7, wherein, The device body includes a recess for receiving at least a portion of the anchor when the anchor is in the passive configuration.

9. The apparatus according to any one of claims 1 to 3, wherein, The device includes an actuator for operating the anchor to securely attach the device body to fetal tissue.

10. The apparatus according to any one of claims 1 to 3, wherein, The immobilized enzyme is a lactate oxidase or lactate dehydrogenase used to detect lactate in fetal tissue or fetal blood.

11. The device according to any one of claims 1 to 3, comprising a guide tube for guiding the device body to fetal tissue via the vagina and cervix.

12. The apparatus according to any one of claims 1 to 3, comprising a plurality of biosensors, each biosensor configured to measure a different analyte in fetal tissue.

13. A system for monitoring the concentration of a lactate analyte in a fetus, the system comprising: a) A device for measuring the concentration of lactate analytes in a fetus, the device comprising: i. A biosensor for electrochemically measuring the concentration of lactate analytes in a fetus, the biosensor comprising: (A) a reactive substance on a working electrode and (B) a countercurrent electrode, wherein the reactive substance of the biosensor comprises an immobilized enzyme to react with the analyte in fetal tissue and / or fetal blood; ii. A needle-shaped protrusion configured to be at least partially inserted into fetal tissue, the needle-shaped protrusion comprising at least a portion of a biosensor, wherein the needle-shaped protrusion comprises a reactive substance and functions as a working electrode of the biosensor; iii. An anchoring member for anchoring a device body to fetal tissue, wherein the anchoring member forms a component separate from the needle-shaped protrusion, wherein the anchoring member is in a helical form, and the device can be anchored to the fetal tissue by rotating the device body; and iv. A device body supporting a biosensor including the needle-shaped protrusions and anchors, the device body being configured to contact a surface area of ​​fetal tissue, and b) An analytical component that communicates electronically with the electrodes of the biosensor, the analytical component being configured to use the electronic signals detected by the biosensor to determine information indicating the concentration of the analyte. The system is configured such that when the device body contacts the surface area of ​​fetal tissue, the device body can be anchored to the contact surface area of ​​the fetal tissue via the anchoring element, and simultaneously, needle-shaped protrusions including reactants can be at least partially inserted into the tissue, causing the reactants of the biosensor to undergo an electrochemical reaction with lactate analytes in the fetal tissue or fetal blood. In response to the electrochemical reaction at the surface of the needle-shaped protrusions acting as working electrodes, the electrodes of the biosensor detect an electronic signal, the intensity of which indicates the concentration of lactate analytes or the rate of change in lactate concentration in the fetal tissue or fetal blood. The device is configured to continuously and in real time monitor the concentration of the lactic acid analyte or the rate of change of the lactic acid analyte concentration.

14. The system of claim 13, further comprising an outer housing for accommodating the analytical component, wherein, The outer casing includes attachments for attaching the outer casing to the mother's body parts.

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