A labor induction and monitoring device

Abstract

A device (100), a system, a method, and a computer program product for a labor induction and monitoring The device (100) comprises: a balloon catheter (101) configured to mechanically stimulate the cervix (128) for cervical ripening, a sensor arrangement (114) comprising at least one sensor configured to obtain measurement data, said measurement data relating to fetal and / or maternal physiological parameters, uterine contraction, cervical ripening progression, and / or cervical balloon expulsion, and a control unit (116) configured to collect the measurement data and / or transmit the measurement data to an external device.

Description

[0001] A LABOR INDUCTION AND MONITORING DEVICE

[0002] Technical field

[0003] The present solution generally relates to a labor induction and monitoring device, a labor induction and monitoring system, a method for monitoring labor induction and a computer program product.

[0004] Background

[0005] Induction of labor is defined as the process of artificially stimulating uterine contractions and cervical dilation at a viable gestational age to accomplish childbirth. Induction of labor is a common procedure to initiate the onset of childbirth if it does not spontaneously start or risks to the mother or fetus have arisen, and when there are no contraindications to labor and vaginal birth. Currently, approximately 20-30 % of pregnant women worldwide undergo labor induction. The most common indications for induction of labor include postdate or post-term pregnancy, pre-labor rupture of fetal membranes, hypertensive complications, and progestational or gestational diabetes. There has been a significant steady increase in the rates of labor induction globally over the last decades, as women are becoming mothers at an advanced age, with obesity and pre-existing medical conditions resulting in various pregnancy complications. The rising rate of labor inductions alongside increasing hospital costs, burdens on healthcare staff, and the growing importance of the maternal childbirth experience have highlighted the need for improved, modem methods and devices for labor induction.

[0006] Induction of labor is typically initiated in a hospital setting under the supervision of medical professionals. However, during the first part of the induction process, which involves cervical ripening, women have the option to return home as outpatients. The balloon catheter remains in place during this time. Once the balloon is expelled, the induction of labor process continues in the hospital.

[0007] These outpatients do not have access to the same level of monitoring and interventions as those who are hospitalized. Therefore, outpatients should be closely monitored throughout the process, to ensure timely detection of any complications and to facilitate necessary medical interventions.

[0008] Currently, there are no effective methods or systems for monitoring the labor induction when the patient is outside the hospital environment. Many of the monitoring tools currently used in hospitals are not designed for use in the home setting and are not practical or feasible for outpatients undergoing labor induction. This indicates a need for improved solutions to ensure comprehensive monitoring of both the mother and fetus during labor induction outside the hospital.

[0009] Summary of the Invention

[0010] The scope of protection sought for various embodiments of the invention is set out by the independent claims. Various embodiments are disclosed in the dependent claims. The embodiments and features, if any, described in this specification that do not fall under the scope of the independent claims are to be interpreted as examples useful for understanding various embodiments of the invention.

[0011] According to a first aspect, a labor induction and monitoring device is provided, wherein the device comprises: a balloon catheter configured to mechanically stimulate the cervix for cervical ripening; a sensor arrangement comprising at least one sensor configured to obtain measurement data, said measurement data relating to fetal and / or maternal physiological parameters, uterine contraction, cervical ripening progression, and / or cervical balloon expulsion; and a control unit configured to collect the measurement data and / or transmit the measurement data to an external device.

[0012] The device according to the invention may provide real-time remote monitoring during mechanical stimulation-based induction of labor, utilizing sensors for efficient, reliable, and user-friendly monitoring of fetal and / or maternal physiological parameters. It also may enable tracking of uterine contractions, cervical ripening progression, and / or cervical balloon expulsion, while the patient is in outpatient care. The device comprises sensor arrangement for collecting measurement data and transmitting this data to an external device for interaction between patients and healthcare providers. Thus, it may enable seamless remote monitoring and improved care during outpatient labor induction, thereby enhancing safety and facilitating communication between the patient and healthcare providers during outpatient treatment. The device may allow for rapid response in the event of potential complications, thereby increasing the safety of both the fetus and the mother and providing the outpatient mother with a sense of security.

[0013] The balloon catheter may be a balloon catheter or a double balloon catheter. The inflated balloon exerts pressure on the cervix, facilitating its dilation and effacement, and also increases the secretion of natural prostaglandins, mimicking the natural onset of labor. The balloon catheter may be, for example, a standard 1 -way Foley balloon catheter, a catheter specifically designed for this application or alternatively, a double-balloon catheter specifically intended for labor induction.

[0014] The balloon catheter may comprise an attachment system, adapted to receive attachment of the control unit. The attachment system may provide a user- friendly and compact method for securing the control unit to the catheter, enhancing ease of use and integration with the sensor arrangement.

[0015] The attachment system may be configured to create an outward force directed from the uterus to accelerate the cervical ripening process. This attachment system may reduce patient discomfort and enhances usability compared to traditional taping methods, providing a more efficient and comfortable experience during cervical ripening.

[0016] The attachment system may comprise an electrode. Incorporating an electrode into the attachment system may enable a stable electrical interface at the mother’s thigh for biopotential-based fetal heart rate or mother heart rate measurements against a second intrauterine electrode, improving signal quality and reliability. This integrated, compact design may reduce the need for separate leads and sensors, thereby enhancing user comfort. The sensor arrangement may comprise at least one sensor attached to the balloon catheter, at least one abdominal sensor, at least one inguinal sensor, and / or at least one pelvic sensor. Preferably, the sensor arrangement comprises at least one sensor attached to the balloon catheter. The sensor arrangement, comprising multiple sensor types, may enhance measurement accuracy and reliability while providing a more comprehensive physiological picture. It may further deliver redundancy and operational robustness, enable situational optimization, and improve user comfort and flexibility.

[0017] The sensor arrangement may comprise at least one sensor attached to and / or integrated into the balloon catheter that is arranged at the proximal end, on the surface of the balloon catheter, and / or inside the balloon catheter. Such placement may reduce external components and cabling, thereby enabling faster setup and enhanced patient comfort. Additionally, deploying the sensor arrangement together with the balloon catheter may simplify sensor placement and further may improve patient comfort.

[0018] At least one sensor of the sensor arrangement may be pre-attached to or preintegrated into the balloon catheter. This configuration may ensure that the sensors are already connected to the catheter, thereby simplifying patient deployment and eliminating separate procedures for sensor placement.

[0019] At least one sensor of the sensor arrangement may be configured to be attached to or detached from the balloon catheter when the balloon catheter has been positioned in the patient. This arrangement may allow on-demand sensor installation, replacement, or removal after catheter placement, thereby providing procedural flexibility and adaptability to varying circumstances.

[0020] At least one sensor of the sensor arrangement may be arranged to be coupled to the catheter via an injection port and / or a separate lumen in the balloon catheter. The advantages may include that utilizing the injection port and / or the separate lumen enable coupling of sensors to standard balloon catheters without special features, may simplify and accelerate deployment while preserving catheter sterility and established workflow and may provide modularity and serviceability for sensor upgrade, replacement, or removal. Additionally, the solution may reduce external cabling to improve patient comfort and enhance reliability through a mechanically secure and leak- resistant coupling point.

[0021] The device may be configured to provide a sensory indicator. An advantage may be that the device may notify the patient or healthcare provider of situations requiring immediate attention, thereby enabling prompt intervention and enhancing safety, further delivering enhanced responsiveness and system reliability.

[0022] The sensory indicator may be an audio alert, haptic feedback, and / or light indicators. Notifications may be delivered using different methods and intensities, enabling graduated alerts tailored to urgency and user context.

[0023] The sensor arrangement may be configured to obtain measurement data of fetal and / or maternal physiological parameters, which are at least one of fetal heart rate, fetal heart-rate variability, fetal movements, fetal temperature, maternal heart rate, maternal heart-rate variability, maternal movements, maternal temperature, maternal positions, uterine contractions, balloon position, and / or cervical ripening progression. Preferably, the measurement data of fetal heart rate, fetal heart-rate variability, uterine contraction strength, duration, and frequency, as well as cervical ripening progression and balloon position, may enhance patient safety by facilitating swift responses to scenarios necessitating medical intervention. Such measurement data may be particularly important during outpatient treatment, where patients, in the absence of such tools, may be unable to respond promptly should a situation demanding medical attention arise. The sensor arrangement may comprise a pressure sensor, and the pressure sensor is optionally a hydrophone, a microphone, a contactless sensor, and / or a membrane-coupled sensor. A pressure sensor may enable multiphenomena measurement. A catheter-fluid coupled pressure sensor may permit non-invasive measurement of uterine contraction pressure (including strength, duration, and frequency) and detection of pressure and acoustic waves associated with the fetal heartbeat within the same configuration, thereby simplifying the hardware architecture and improving measurement reliability.

[0024] The sensor arrangement may comprise an intra-uterine Doppler and / or a biopotential sensor. The electrical signal generated by fetal heart events may be acquired at the proximal end of the catheter via saline conduction and / or capacitive coupling, eliminating the need for a fetal scalp electrode or any separate invasive sensor and thereby reducing invasiveness and simplifying setup. An intra-uterine Doppler implementation may improve signal quality and robustness due to the transducer’s close proximity to the fetus, and may enhance stabilization by securing the transducer to an intra-uterine balloon catheter.

[0025] The sensor arrangement may comprise at least one abdominal sensor, and the at least one abdominal sensor is configured to perform measurements based on at least one of electrocardiography, phonocardiography, seismocardiography, vibrocardiography, or Doppler ultrasound. The abdominal sensor may enable non-invasive and comfortable monitoring of cardiac function by utilizing one or more measurement modalities. The abdominal placement may improve user comfort, may support long-term and wearable use, and may allow multimodal signal fusion, thereby enhancing measurement accuracy and diagnostic reliability.

[0026] The sensor arrangement may comprise at least one inguinal sensor, and the at least one inguinal sensor is configured to perform measurements based on at least one electromyography, electrocardiogram, pressure sensing, force sensing, impedance measurement, or ultrasound. The inguinal placement may provide improved user comfort and suitability for long-term or wearable applications.

[0027] The sensor arrangement may comprise at least one pelvic sensor, and the at least one pelvic sensor is configured to perform measurements based on at least one of electromyography, pressure sensing, force sensing, impedance measurement, or ultrasound. The pelvic placement may provide improved user comfort and suitability for long-term or wearable applications.

[0028] The sensor arrangement may comprise a temperature sensor. Variations in maternal internal temperature during labor induction may signify complications necessitating medical intervention, thereby positioning continuous temperature monitoring as a critical component for optimizing procedural safety during labor induction.

[0029] The sensor arrangement may comprise an inertial measurement unit and / or a motion sensor. The inertial measurement unit or the motion sensor may detect maternal movements, allowing compensation for artifacts in fetal heart rate and uterine contraction signals caused by such movements. The inertial measurement unit or the motion sensor data may also reveal maternal positions and activities, such as sitting, standing, lying down, or walking. Since maternal activity, such as walking, is thought to enhance cervical ripening through mechanical stimulation, this information may guide patients toward activities that may promote more effective ripening outcomes.

[0030] The control unit may comprise at least one processor and at least one memory, including computer program code. These components may enable local preprocessing (such as filtering, artifact reduction, and feature extraction) to improve the quality and efficiency of transmitted measurement data. They may also provide on-device storage to buffer and retain data during connectivity interruptions, with secure, managed transmission (e.g., batching, compression, encryption) once the connection is restored. These capabilities may enhance robustness and continuity of care by allowing adaptive algorithms to operate locally and by maintaining reliable data logging even during network outages.

[0031] The external device may be at least one of a remote processor, a mobile device, and / or a monitoring device. The ability to use a remote processor, a mobile device, and / or a monitoring device may enable access to measurement data from different locations (home care, outpatient clinic, hospital), thereby facilitating deployment and scalability. A remote processor may enable access from different locations, supporting distributed monitoring and intervention by healthcare providers. Utilization of a mobile phone may place the interface and alerts directly in the patient’s hands, improving usability and patient engagement in home and outpatient settings.

[0032] The device may be battery-powered. The battery-powered device may provide cordless operation for improved ease of use and location-independent deployment.

[0033] According to a second aspect, a labor induction and monitoring system is provided, wherein the system comprises; a labor induction and monitoring device; and at least one external device, wherein the labor induction and monitoring device is configured to transmit the collected measurement data to at least one external device.

[0034] An advantage of the present invention is that it enables real-time outpatient monitoring during labor induction. To achieve this, to the invention may ensure continuous data transmission between the labor induction and monitoring system and healthcare providers, regardless of the patient’s location. This is accomplished by a system that continuously collects measurement data from the sensor arrangement and transmits the data to healthcare providers. The labor induction and monitoring device may be configured to transmit the collected measurement data to at least one external device utilizing long-range communication technologies, such as cellular networks. Transmitting collected measurement data to at least one external device via long-range communication technologies, such as cellular networks, may enable continuous connectivity beyond local range, support real-time oversight without reliance on nearby relay devices, and improve reliability.

[0035] The labor induction and monitoring device may be configured to transmit the collected measurement data to a first external device utilizing short-range wireless communication technology, such as Bluetooth. The first external device may be configured to transmit the collected measurement data to a second external device utilizing long-range communication technologies, such as cellular networks. By initially transmitting data from the labor induction and monitoring device to a first external device using short-range wireless communication technology, the system may maintain low transmission power, allow for a smaller battery and therefore a more compact design. This approach may also keep radiation emissions low, support regulatory safety compliance, enhance data security, and minimize interference with other hospital and at-home devices.

[0036] At least one external device may comprise a mobile device, a remote processor, and / or a monitoring device. When the external device is a mobile phone, the patient’s own device may be utilized, thereby reducing equipment costs, leveraging the phone’s native communication technologies and mobile network connectivity, and ensuring data transmission regardless of location as the device travels with the patient. The remote processor may further enable access to the data from any location. Additionally, the monitoring device may enable healthcare providers to access the data and review it easily through a clear, visual interface. The first external device may be a mobile device, and the second external device is a remote processor and / or a monitoring device. When the external device is a mobile phone, the patient’s own device may be utilized, thereby reducing equipment costs, leveraging the phone’s native communication technologies and mobile network connectivity, and ensuring data transmission regardless of location as the device travels with the patient. The remote processor and / or the monitoring device, as the second external device, may enable healthcare providers to access, review, and process the data within the healthcare environment and make informed, timely decisions for the benefit of the outpatient.

[0037] According to a third aspect, a method for monitoring labor induction is provided, wherein the method comprises; collecting measurement data obtained via at least one sensor of a sensor arrangement of a labor induction device; and transmitting said measurement data to an external device.

[0038] In a fourth aspect, a computer program product is provided, wherein the product comprises a computer program code may be configured to, when executed by at least one processor, cause a labor induction and monitoring system to perform a method.

[0039] An advantage of the present invention is that it may improve safety, enhance efficacy, increase cost efficiency, and elevate patient satisfaction, particularly in the context of real-time outpatient monitoring during labor induction. Ongoing monitoring of the labor induction process may substantially enhance efficacy by enabling healthcare providers to make more timely and informed decisions regarding induction management, such as medication administration, thereby optimizing procedural outcomes. Continuous monitoring of additional parameters, such as maternal activity, may further improve induction outcomes by supporting guidance toward behaviours that facilitate more efficient cervical ripening. By enhancing the safety of outpatient care and making it a feasible option for a wider population, substantial cost savings for healthcare providers may be realized. This treatment approach may reduce the workload on healthcare providers, and may free valuable hospital resources and space, contributing to overall healthcare efficiency and effectiveness. Moreover, improving the safety and efficacy of the labor induction procedure may yield significant savings by reducing the incidence of interventions such as cesarean sections and neonatal intensive care necessitated by complications arising during the labor induction process. Additional cost savings may be achieved by minimizing the need for repeated cardiotocography (CTG) measurements and the associated costs related to staff, space, and equipment.

[0040] Enhancing the safety and viability of outpatient treatment during labor induction may elevate the childbirth experience for a broader population of expectant mothers. Furthermore, providing continuous monitoring of fetal and maternal well-being and the induction process may offer increased peace of mind for expectant mothers, potentially leading to improved outcomes and heightened patient satisfaction throughout the labor induction process.

[0041] Brief description of the drawings

[0042] FIG. 1 Illustrates an example labor induction and monitoring device,

[0043] FIG. 2 illustrates an example device positioned in the cervix,

[0044] FIG. 3 illustrates a system according to a first embodiment, and

[0045] FIG. 4 illustrates a system according to a second embodiment.

[0046] Detailed description of the Invention

[0047] The following description and drawings are illustrative and are not to be construed as unnecessarily limiting. The specific details are provided for a thorough understanding of the disclosure. However, in certain instances, well- known or conventional details are not described in order to avoid obscuring the description. In this specification, reference to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. References to an embodiment can be, but are not necessarily, references to the same embodiment in the present disclosure.

[0048] The terms “proximal” and “distal” are used herein to refer to the ends of the labor induction device, or more specifically, to the ends of the balloon catheter or the shaft of the catheter of the labor induction device. The proximal end refers to the end which is in some embodiments equipped with ports and / or valves and may be attached to the thigh of a patient. In other words, the proximal end is the same as the external end. The distal end refers to the end with an inflatable balloon, which may be inserted to the uterus of the patient.

[0049] Labor induction is a common procedure to initiate the onset of childbirth if it does not spontaneously start or if risks to the mother or fetus have arisen. Current methods for the labor induction, such as balloon catheters, prostaglandin drugs, or their combination, have limitations that result in induction failure in approximately 35% of cases, leading to cesarean sections. This, in turn, increases the risk of childbirth complications and increases healthcare costs.

[0050] The present invention relates to a device, a system, a method and a computer program product for labor induction and monitoring.

[0051] A labor induction and monitoring device comprises a balloon catheter that is configured to mechanically stimulate the cervix for cervical ripening. Mechanically stimulation via a balloon catheter is a common method used for cervical ripening in labor induction. This involves insertion of a catheter through the cervix into the lower segment of uterus below the fetus’s head. The uterine end of the catheter is equipped with a balloon that is inflated with saline, for example about 40-80 ml. The catheter may be a balloon catheter or a double balloon catheter. The inflated balloon exerts pressure on the cervix, helping it to dilate and efface, increases the secretion of natural prostaglandins, mimicking the natural onset of labor. Usually, a standard 1 -way Foley balloon catheter, or alternatively a double balloon catheter specifically intended for labor induction, is used for mechanical stimulation. The labor induction and monitoring device comprises a sensor arrangement. The sensor arrangement comprises at least one sensor configured to obtain measurement data. The measurement data may be fetal and / or maternal physiological parameters, uterine contraction, cervical ripening progression, and / or cervical balloon expulsion.

[0052] The sensor arrangement may interface with electronics located at the catheter's proximal end, configured to manage recording, transmission, and other necessary functions, thereby effectively minimizing the extent of electronic components situated within the patient's body. The sensor arrangement may be a compact, battery-powered solution that maximizes patient comfort and ease of use.

[0053] During labor induction, measuring uterine contractions and fetal heart rate is important to assess the well-being of both the mother and the fetus. The frequency, duration and intensity of uterine contractions may be monitored to ensure adequate labor progress, to guide the administration of uterotonic medication during labor induction and labor, and to interpret the fetal heart rate in relation to contractions to ensure fetal wellbeing or diagnose distress during labor. Fetal heart rate may be measured to evaluate fetal oxygenation and to identify any signs of fetal distress, which might be indicative of compromised blood flow or oxygen supply to the fetus. Both parameters may be monitored to enable timely medical interventions, to adjust labor induction strategies if needed, and to make critical decisions, such as whether to proceed with a cesarean section or other emergency measures.

[0054] The labor induction is typically initiated in the hospital by a healthcare provider. However, during the first part of the induction process, which involves cervical ripening, women may return home as outpatients while the balloon catheter is in place. After the balloon is expelled, the labor induction process is continued in the hospital. In Finland and many other countries, around 30% of women stay at home during their induction. Large international studies have shown that outpatient treatment is a safe and effective option for labor induction. Previous research has indicated that 90% of women feel safe and positive about staying at home during the cervical ripening phase of labor induction. Outpatient treatment during cervical ripening may offer several benefits for women, including reduced cost, increased comfort and convenience, greater control over the induction process and more natural labor experience. Outpatient treatment may be less expensive than inpatient treatment, as it may eliminate the need for staff and facility resources and their associated expenses. Outpatient treatment may allow women to remain in their own familiar surroundings, which may help reduce stress and pain, and increase comfort. Outpatient treatment may give women a greater sense of an active role and control over the timing and pace of the induction process. Outpatient treatment may allow women to experience a more natural labor process, as they may move and engage in activities that promote labor and release pain, such as walking or taking a warm bath.

[0055] Given the safety and positive experiences associated with outpatient IOL, it is likely that this approach will become increasingly common in the future. While outpatient treatment for labor induction can offer several benefits, there are also concerns associated with this approach. One of the primary concerns is the wellbeing of the fetus. Women who undergo outpatient treatment don’t have access to the same level of monitoring and intervention as those who are hospitalized. Outpatients should be closely monitored throughout the process, with regular assessments of uterine contractions and fetal heart rate.

[0056] The labor induction and monitoring device comprises a control unit configured to collect the measurement data and / or transmit the measurement data to an external device. The control unit may include components for obtaining measurement data and may execute software configured to perform such data acquisition and storage. In addition, it may further manage preprocessing, formatting, and transmission of the collected measurement data.

[0057] FIG. 1 illustrates a labor induction and monitoring device 100 comprising a balloon catheter 101. The balloon catheter 101 comprises a shaft 102 with a proximal end 104 and a distal end 106. An inflatable balloon 108 is positioned at the distal end 106 of the shaft 102. In FIG. 1 , the balloon 108 is shown in its inflated state. The balloon catheter 101 further includes ports 110, 112 at the proximal end 104 of the shaft 102. A first port 110 is coupled to a first lumen extending from the proximal end to the inflatable balloon 108. The first port 110 and the first lumen may be used to inflate and / or deflate the balloon 108. The first port 110 may be implemented as a self-sealing injection port. Such a selfsealing injection port may be configured to remain closed or sealed until a compatible device, such as a syringe, is coupled to the port. Removal of the device may close or re-seal the self-sealing injection port. Such sealing / closing and unsealing / opening mechanisms may be implemented with luer lock fittings that comprise e.g. a tubular part for opening and / or closing the port or a valve of the port. Additionally, the luer lock fitting may comprise a threaded interface for attachment. Alternatively, or additionally to the first port 110, any other port described herein may be implemented as a self-sealing injection port. A second port 112 is coupled to a second lumen extending from the proximal end 104 of the shaft 102 to an opening on the distal side of the inflatable balloon 108, or more specifically, at the distal end 106 of the shaft 102. In some embodiments, the second port 112, second lumen, and the opening may be omitted.

[0058] A sensor arrangement 114 and a control unit 116 are attached to the first port 110 at the proximal end 104 of the balloon catheter 101. In the embodiment of FIG. 1 , the sensor arrangement 114 comprises a first sensor 118 positioned on the surface of the balloon 108 at the distal end 106 of the balloon catheter 101 , and a second sensor 120 attached to the first port 110 at the proximal end 104. The first sensor 118 may be, for example, a membrane-coupled sensor, and the second sensor 120 may be, for example, a fluid pressure transducer. The control unit 116 comprises at least one processor 122 and at least one memory 124, as well as components 126 that enable transmission of the collected measurement data via short-range or long-range communication technology.

[0059] In one embodiment the balloon catheter 101 may comprise an attachment system, which is adapted to receive attachment of the control unit 116. The attachment system may be incorporated directly into the sensor arrangement 114, which is securely attached to the balloon catheter’s 101 injection port. In a preferred embodiment, the attachment system may comprise an adhesive patch, similar to a standard ECG electrode patch, equipped with a snap fitting (in whole or in part), such as a snap button. The matching part of the snap button is integrated into the sensor arrangement 114. In further embodiments, the attachment system may comprise a belt or strap attached to the patient’s thigh, offering a secure yet comfortable alternative. In one embodiment the attachment system may be configured to create an outward force directed from the uterus to accelerate the cervical ripening process. Maintaining the balloon's 108 position against the internal cervical is essential for effective cervical ripening and to prevent issues such as fetal movements causing the balloon 108 to migrate upward into the uterus. The catheter 101 may be secured to the patient's inner thigh to stabilize both the catheter 101 and the balloon's 108 position. The attachment interface may enable adjustable traction to accommodate the balloon's 108 movement as it advances through the cervix. The attachment interface may also include a spring-like elastic mechanism to offset maternal movements, delivering steadier traction than a rigid attachment. Other embodiments may include specialized wearable garments designed for this purpose.

[0060] In one embodiment the attachment system may comprise an electrode. If fetal heart rate or mother heart rate detection relies on biopotential measurements, an electrode may be integrated into the attachment system to provide an electrical connection at the mother’s thigh, enabling measurement against the second electrode inside the uterus. Furthermore, the attachment system may be leveraged as a stable measurement point on the mother’s thigh for measuring maternal heart beats via a PPG or ECG sensor, or other suitable measurement technique, integrated in the sensor arrangement 114.

[0061] In one embodiment the sensor arrangement 114 may comprise at least one sensor attached to the balloon catheter 101 , at least one abdominal sensor, at least one inguinal sensor, and / or at least one pelvic sensor. The sensor arrangement 114 may comprise sensors that operate outside the catheter 101 , to measure maternal and fetal health parameters. One embodiment of such an external assembly includes a heart rate sensor such as a photoplethysmogram (PPG) or ECG sensors, to detect maternal heart beats, integrated into the sensor arrangement 114 at the proximal end 104 of the catheter 101 . Another embodiment may include a separate abdominal sensor that measures fetal and maternal parameters from the maternal abdomen. Another embodiment of the sensor arrangement 114 may include a PPG sensor on the mother’s finger, or separate ECG sensors on other parts of the maternal body, intended for maternal heart rate measurement. These sensors, separate from the catheter sensor, interface wirelessly or via a cable connection with the catheter sensor, enabling accurate temporal synchronization and a common transmission protocol to be used by all sensors.

[0062] In one embodiment the sensor arrangement 114 comprises at least one sensor attached to and / or integrated into the balloon catheter 101 that is arranged at the proximal end 104, on the surface of the balloon catheter 101 , and / or inside the balloon catheter 101 . For example, pressure transducers that interface with the fluid inside catheter 101 through the injection port may be used for fluid insertion. The device may utilize a standard luer-actuated syringe port, which is a common feature for inflating balloon catheters 101 with fluid. A specialized mechanical interface may be employed to keep the inflation port open, thereby facilitating free fluid movement between the catheter 101 and a designated compartment within the sensor arrangement housing the pressure transducers. This embodiment may leverage existing catheters already used for mechanical stimulation, eliminating the need to design a new catheter solely for this purpose. Alternatively, a novel catheter may be specifically designed to incorporate a designated port intended solely for interfacing with the sensor assembly.

[0063] In one embodiment at least one sensor of the sensor arrangement 114 may be pre-attached to or pre-integrated into the balloon catheter 101. The sensor arrangement 1 14 may be seamlessly integrated into a novel balloon catheter, i.e. , a catheter specifically designed for this purpose, thereby eliminating the requirement for a distinct sensor-catheter interface.

[0064] In one embodiment at least one sensor of the sensor arrangement 114 may be arranged to be coupled to the catheter 101 via an injection port and / or a separate lumen in the balloon catheter 101. In another embodiment, a separate sensor arrangement 114 may leverage a separate lumen in the balloon catheter 101 , through which a slim sensor arrangement 114 may be introduced into targeted areas in the uterus, cervix or vagina.

[0065] In one embodiment at least one sensor of the sensor arrangement 114 may be configured to be attached to or detached from the balloon catheter 101 when the balloon catheter 101 has been positioned in the patient. A separate lumen in the balloon catheter 101 may be used to facilitate the insertion of sensors into targeted locations within the uterus, cervix, or vagina. The sensor arrangement 114 may be engineered in a slender configuration that allows for insertion and removal while the catheter 101 remains in place, or alternatively, the sensors may be pre-integrated into the catheter 101 in a fixed arrangement prior to insertion. The sensor arrangement 114 may comprise a single sensor or alternatively encompass a diverse array of biomedical sensors, each configured to assess distinct fetal and maternal health parameters. These sensors may incorporate electrodes serving as electrical potential measurement points.

[0066] In one embodiment the device 100 may be configured to provide a sensory indicator. The sensor arrangement 114, abdominal sensor, or both may be equipped with one or more sensory indicators. The sensory indicators may include an audio alert, haptic feedback (e.g., a vibrator), light indicators, or similar devices. The sensory indicator may notify the patient or healthcare provider of situations requiring immediate attention. These indicators may alert users to medical emergencies detected by the sensor arrangement 114 or technical issues, including sensor detachment, low battery levels, or disconnection from a host device.

[0067] Haptic, audio, or visual indicators may be integrated into the catheter 101 or abdominal sensors to provide additional patient alerts. These direct indicators may be especially useful in urgent situations, such as medical emergencies or technical issues like sensor detachment or disconnection from the external device or from the healthcare provider. Since the sensors remain in contact with the patient throughout induction, they may deliver immediate notifications that may be more effective than alerts from a mobile or external device.

[0068] In one embodiment the sensor arrangement 114 may be configured to obtain measurement data of fetal and / or maternal physiological parameters, which are at least one of fetal heart rate, fetal heart-rate variability, fetal movements, fetal temperature, maternal heart rate, maternal heart-rate variability, maternal movements, maternal temperature, maternal positions, uterine contractions, balloon 108 position, and / or cervical ripening progression.

[0069] In one embodiment the sensor arrangement 114 may comprise a pressure sensor, and the pressure sensor is optionally a hydrophone, a microphone, a contactless sensor, and / or a membrane-coupled sensor. The device 100 may leverage the fluid within the catheter 101 to measure uterine contractions non- invasively, based on the pressure changes occurring due to contractions. Uterine contractions exert a compressing force on the balloon 108, causing a pressure increase on its internal fluid. This pressure change, correlating with the contraction pressure, may be measured from the proximal end 104 of the catheter 101 using a fluid pressure transducer. A fluid pressure transducer may, for example, be a membrane-coupled sensor.

[0070] The pressure sensor designed to measure intrauterine pressure variations associated with contractions. The sensor may additionally capture vibrations emanating from fetal heartbeats. For enhanced detection of these low amplitude, high-frequency vibrations, a microphone or hydrophone may be employed.

[0071] FIG. 2 illustrates a labor induction and monitoring device 100 positioned within the cervical canal to initiate labor induction, with a catheter 101 inserted through the cervix 128 into the lower uterine segment 130 below the fetus’s head 132. The balloon 108 at the distal end 106 of the balloon catheter 101 is inflated, for example, with saline. The device 100 further comprises a sensor arrangement 114 including a second sensor 120 attached to the first port 110 of the catheter 101 , and a first sensor 118 attached to the second port 112. Uterine contractions exert a compressive force on the balloon 108, causing the pressure inside the catheter 101 to increase. The pressure increase is sensed by the second sensor 120 such as a pressure transducer at the proximal end 104 of the catheter 101 .

[0072] Wave phenomena emanating from the fetal heartbeat may be captured by utilizing the catheter fluid-pressure-based measurement concept. The device 100 may employ two distinct methods: capturing pressure waves sourced from pulsations primarily occurring at the fontanelle or other parts of the fetal body, and detecting sound waves that propagate from the fetal heart through fetal and maternal tissues. The first methodology involves lower frequency mechanical oscillations that influence the fluid dynamics within the catheter 101 , resulting from the physical interaction between the balloon 108 and the fetal body, and may be detected using a piezoelectric transducer, hydrophone, or other suitable sensor placed at the catheter's 101 proximal end 104.

[0073] In one embodiment, fetal heartbeats create vibrations that travel through the amniotic fluid. These vibrations propagate through the catheter fluid via the balloon 108 inflation lumen and are sensed by a vibration transducer, such as the second sensor 120 in FIG. 2, located at the proximal end 104 of the catheter 101 .

[0074] The second method focuses on higher-frequency sound waves originating from the fetal heart, which traverse complex pathways through tissue and fluid, and may be captured by transducers specifically designed for acoustic detection, such as microphones or hydrophones.

[0075] Furthermore, fluctuations in the catheter's internal fluid pressure may serve as a real-time gauge of cervical ripening progression. As cervical ripening advances, the balloon 108 gradually moves through the cervical canal into the vagina, resulting in distinct pressure alterations on the balloon 108. These variations in the pressure signal, recorded at the proximal end 104 of the catheter 101 , may be used to assess cervical ripening progression and to generate alerts when the balloon 108 is fully expelled, signifying a ripe cervix 128.

[0076] In one embodiment, air may serve as the medium for detecting pressure alterations originating from the uterus. A distinct lumen within the catheter 101 , akin to the drainage lumen found in a standard Foley catheter, may act as the measurement conduit. In this configuration, vibrations induced by fetal heartbeats or uterine contractions may be assessed at the proximal end 104 of this lumen, utilizing an air-coupled microphone, pressure transducer, or another contactless sensor.

[0077] In one embodiment, fetal heartbeats create vibrations that travel through the amniotic fluid. These vibrations propagate through the air within an empty lumen and are sensed by an air-coupled vibration transducer, such as the second sensor 120 in FIG. 2, located at the proximal end 104 of the catheter 101.

[0078] In one embodiment the sensor arrangement 114 may comprise a combined pressure / vibration sensor can be constructed utilizing piezoelectric materials, optionally comprising a thin piezoelectric membrane. This configuration may offer advantages by integrating the membrane into the balloon 108 surface, such as the first sensor 118 in FIG. 1 , thereby facilitating a substantial surface area for effective vibration and pressure measurement. In one embodiment the sensor arrangement 114 may comprise an intra-uterine Doppler and / or a biopotential sensor. The device 100 may leverage the measurement of changes in electrical potential within the fluid, operating on a principle analogous to fetal scalp electrocardiogram (ECG) measurement. Fetal heart events generate an electrical signal, which may be detected as a variation in electrical potential between the fetus and another measurement point, typically the mother’s thigh. In this embodiment of the invention, saline fluid, being a conductor, serves as the intermediary between the fetus and a measurement electrode situated at the proximal end 104 of the catheter 101 . Even in a standard balloon catheter 101 , where the balloon 108 consists of insulating materials, a capacitive link may be established between the internal fluid and the fetal heart’s electrical activity. This connection may allow the electrical signal to be interpreted via the catheter's saline from the proximal end 104.

[0079] The catheter 101 may also incorporate features designed to reduce the impedance between the measurement location in the uterus and the electrode at the proximal end 104 of the catheter 101. These features could include integrating conductive materials between the saline and the distal wall of the balloon 108, or alternatively, embedding a conductive material that spans the length of the catheter 101 , connecting the uterus and the proximal end 104. Enhancing electrical connectivity between the saline and surrounding tissues may be further achieved by constructing the balloon 108 from a semipermeable material. This approach may permit voltage-carrying particles to traverse the material while retaining the fluid inside, effectively minimizing electrical impedance between the saline and the surrounding tissues.

[0080] The counter-electrode, which may be attached to the mother’s thigh, may alternatively be placed elsewhere on the mother’s body to increase the signal- to-noise ratio of the measurement, or for improved usability. This electrode may be provided by the attachment system.

[0081] This fluctuation in electrical potential may also be harnessed to identify uterine contractions, by assessing the electrical activity generated by the uterine muscles during contractions, analogous to electromyography (EMG) measurement methodology. In one embodiment, a voltage increase is generated by fetal cardiac activity. A capacitive link is established between the saline inside the balloon 108 and the electric potential outside the balloon 108. Conductive saline within the balloon 108 inflation lumen forms an electrical path between the balloon 108 and the proximal end 104 of the catheter 101. Fetal heartbeats are detected based on the voltage signal measured between the saline and an electrode, such as the electrode 134 on the mother’s thigh 136 shown in FIG. 2.

[0082] The sensor arrangement 114 may comprise an ultrasound transducer, configured to determine fetal heart rate by detecting fluctuations in blood flow within the fetus via the Doppler effect, mirroring standard abdominal Doppler ultrasound methodologies. The intra-uterine Doppler approach may provide enhanced benefits over abdominal Doppler measurements due to the proximity and stabilization of the sensor relative to the fetus, secured by the balloon 108 inside the uterus. Abdominal Doppler measurements typically encounter accurate sensor placement to acquire high-quality signals of fetal heart rate.

[0083] In one embodiment the sensor arrangement 114 may comprise at least one abdominal sensor, and the at least one abdominal sensor is configured to perform measurements based on at least one of electrocardiography, phonocardiography, seismocardiography, vibrocardiography, or Doppler ultrasound.

[0084] The fetal heart rate and contraction information detected by the sensor arrangement 114 may be augmented by another sensors located on the mother’s abdomen. This abdominal sensor may be secured to the patient’s skin using a variety of methods, such as adhesives, suction cups, or attachment through specially designed belts, straps, or other wearable garments. Additionally, the abdominal sensor may be embedded into fabrics or integrated into smart textiles to create wearable fetal monitoring devices. The abdominal sensor may utilize various sensing methods, such as abdominal ECG, phonocardiography, seismocardiography, vibrocardiography, Doppler ultrasound, or other ultrasound-based methods. The information from the abdominal sensor may be used independently for fetal heart rate or contraction detection, or it may be combined with the sensor data derived from the sensor arrangement 114 so that the resulting information has reduced uncertainty compared to using the catheter sensor and abdominal sensor individually.

[0085] In one embodiment the sensor arrangement 114 may comprise at least one inguinal sensor, and the at least one inguinal sensor is configured to perform measurements based on at least one electromyography, electrocardiogram, pressure sensing, force sensing, impedance measurement, or ultrasound.

[0086] In one embodiment the sensor arrangement 114 may comprise at least one pelvic sensor, and the at least one pelvic sensor is configured to perform measurements based on at least one of electromyography, pressure sensing, force sensing, impedance measurement, or ultrasound.

[0087] In one embodiment the sensor arrangement 114 may comprise a temperature sensor, configured for continuous monitoring of maternal internal temperature. Variations in maternal internal temperature during labor induction may signify complications necessitating medical intervention, thereby positioning continuous temperature monitoring as a critical component for optimizing procedural safety during labor induction.

[0088] In one embodiment the sensor arrangement 114 may comprise an inertial measurement unit and / or a motion sensor. The inertial measurement unit (IMU) or a similar motion sensor may detect maternal movements, allowing compensation for artifacts in fetal heart rate and uterine contraction signals caused by such movements. IMU or motion-sensor data may also reveal maternal positions and activities, such as sitting, standing, lying down, or walking. Since maternal activity, such as walking, is thought to enhance cervical ripening through mechanical stimulation, this information may guide patients toward activities that may promote more effective ripening outcomes.

[0089] In one embodiment the control unit 116 may comprise at least one processor 122 and at least one memory 124, including computer program code. The control unit 116 may include components 126 for obtaining measurement data and may execute software configured to perform such data acquisition and storage. It may further manage preprocessing, formatting, and transmission of the collected measurement data. The control unit 116 may comprise components 126 enabling direct internet access. In this embodiment, the sensor data stream may be transmitted directly to the healthcare provider and patient interfaces via the internet.

[0090] In one embodiment the external device may be at least one of a remote processor 122, a mobile device, and / or a monitoring device. The widespread use of mobile devices be leveraged by utilizing either the patient’s own device or one supplied by the healthcare provider as the external device. The external device may be a personal computer, a mobile device, such as a smartphone, tablet computer, laptop, smart watch, or another mobile computing device or wearable device. Alternatively, a dedicated device can be developed specifically to serve as an internet access point and patient interface for the device 100 described in this invention. In another embodiment, a smart watch or other wrist-worn device or other wearable device worn by the mother, is utilized as the external device, ensuring close proximity between the sensor arrangement 114 and the external device. In this embodiment, additional sensors may be incorporated into the wearable device, used for auxiliary measurements such as maternal heart rate.

[0091] In one embodiment the device 100 is battery-powered. It may utilize a replaceable battery or alternatively be rechargeable from mains power.

[0092] A labor induction and monitoring system comprises a labor induction and monitoring device 100 and at least one external device. The labor induction and monitoring device 100 is configured to transmit collected measurement data to at least one external device. The disclosed invention is designed to enable real-time, outpatient monitoring during labor induction. The system may provide continuous data transmission between the labor induction and monitoring device 100 and healthcare providers, regardless of the patient’s location.

[0093] In one embodiment the labor induction and monitoring device 100 may be configured to transmit collected measurement data to at least one external device utilizing long-range communication technologies, such as cellular networks. The system may comprise components 126 enabling direct internet access. In this embodiment, the sensor data stream may be transmitted directly to the healthcare provider and patient interfaces via the internet. In one embodiment the at least one external device may comprise a mobile device, a remote processor 122, and / or a monitoring device. Measurement raw data may be sent to a cloud-based server or a remote processor 122, where the algorithms are executed. This approach takes advantage of cloud computing, removing limitations imposed by the processing power of peripheral devices such as sensors and the external device. This embodiment may require a stable, high-bandwidth internet connection, which may limit usability in some environments. Additional embodiments may implement a combination of these approaches, with specific signal analysis steps occurring at various stages of the data stream.

[0094] FIG. 3 illustrates the system wherein the control unit 116 of the labor induction and monitoring device 100 comprises components 126 that enable the transmission of the collected measurement data to a first external device 138, such as a remote processor 122 via long-range wireless communication technologies 140, such as a cellular network. The first external device 138 may enable access to the data by, for example, a healthcare provider’s monitoring device and the patient’s own device, such as a mobile device.

[0095] In one embodiment the labor induction and monitoring device 100 may be configured to transmit the collected measurement data to a first external device 138 utilizing short-range wireless communication technology, such as Bluetooth, and the first external device 138 is configured to transmit the collected measurement data to a second external device utilizing long-range communication technologies 140, such as cellular networks.

[0096] Common data transmission protocols, such as Bluetooth or Bluetooth Low Energy (BLE), Wi-Fi Direct, or similar protocols may be used between the first external device 138 and the second external device. Other possible short- range wireless communication technologies may include, for example, NFC, Zigbee, Thread, or UWB. These protocols facilitate seamless data transfer between mobile and peripheral devices.

[0097] In one embodiment, the first external device 138 may be a mobile device, and the second external device may be a remote processor and / or a monitoring device. Various embodiments of the disclosed system may use different architectures for collecting, analyzing, and transmitting measurement data and related information. In the preferred embodiment, data from the sensor arrangement 114 is first sent via a low-power transmission protocol or a short-range wireless communication technology to a nearby first external device 138, such as a mobile device or a dedicated device designed for this purpose. This first external device 138, equipped with internet connectivity, then uploads the data to a second external device such as a remote processor or a server, where it is relayed in real time to the healthcare provider’s interface over the internet, allowing for continuous remote monitoring.

[0098] FIG. 4 illustrates the system wherein the control unit 116 of the labor induction and monitoring device 100 comprises components 126 that enable the transmission of the collected measurement data to a first external device 138, such as a mobile device via short-range wireless communication technologies 142, such as Bluetooth. The first external device 138 is configured to transmit the collected measurement data to a second external device 144, such as a remote processor via long-range wireless communication technologies 140, such as cellular networks. The second external device 144 may enable access to the data by, for example, a healthcare provider’s monitoring device and the patient’s own device, such as a mobile device.

[0099] The system relies on signal processing algorithms to extract physiological parameters and other measurement data, and related information, such as fetal heart rate, uterine contractions, balloon 108 expulsion, patient activity, and sensor attachment from raw sensor signals. Signal analysis may occur at different stages of the data stream, depending on the computational demands of each type of analysis.

[0100] In one embodiment, these algorithms are implemented on microcontroller units (MCUs) embedded within the control unit 116, allowing only the processed health parameters to be transmitted rather than the entire raw data stream. This may reduce bandwidth requirements, making the system lighter and more robust. Another embodiment may utilize the processing power of the external device to run the algorithms, thus reducing internet bandwidth demands.

[0101] In one embodiment, raw data may be sent to a cloud-based server or a remote processor, where the algorithms are executed. This approach may take advantage of cloud computing, removing limitations imposed by the processing power of peripheral devices such as sensors and the external device. This embodiment may require a stable, high-bandwidth internet connection, which may limit usability in some environments. Additional embodiments may implement a combination of these approaches, with specific signal analysis steps occurring at various stages of the data stream.

[0102] A method for monitoring labor induction, comprises the following steps; collecting measurement data obtained via at least one sensor of a sensor arrangement 114 of a labor induction device 100, and transmitting said measurement data to an external device.

[0103] A computer program product comprises computer program code configured to, when executed by at least one processor 122, cause a labor induction and monitoring system to perform a method for monitoring labor induction.

[0104] The computer program product may provide distinct user interfaces for different users. Namely, the patient has their own user interface and the healthcare provider has their own. The healthcare provider’s interface displays comprehensive health data on fetal and maternal well-being during labor induction. In one embodiment, fetal heart rate and uterine contraction data from the sensor system may be presented in a format similar to the standard CTG graph. This familiar format may allow healthcare provider to quickly interpret the information, facilitating seamless integration into existing care protocols, minimizing the need for additional training, and reducing the cost of transitioning from older systems to the new system. The healthcare provider’s interface may also offer access to expanded data, including situational overviews, raw sensor data, additional health metrics (such as maternal heart rate or fetal movement), balloon 108 expulsion status, patient activity insights, and patient contact information. It may also incorporate communication features, allowing providers to send text messages, voice messages, or alerts directly to the patient’s interface (described below), enhancing real-time interaction and support.

[0105] The patient’s interface is accessible via the patient’s own mobile device or one provided by the healthcare provider. In cases where a dedicated external device serves as an internet access point for the labor induction and monitoring device 100, the patient interface may be integrated directly into this device. The patient interface may provide simplified health information compared to the healthcare provider’s interface; for instance, fetal heart rate and uterine contraction data may be displayed as a single number or other onedimensional indicator instead of a time-domain graph. This design may limit the potential for misinterpretation by the patient, helping to prevent unnecessary conclusions or potentially unsafe decisions based on limited medical expertise.

[0106] A key feature of the patient interface may be facilitating communication between the patient and healthcare provider in remote care settings. The interface may alert the patient when the system or a healthcare provider detects a situation requiring attention. In cases where patient action is necessary, it may provide clear guidance on appropriate steps. Serving as the recipient of messages and alerts from the healthcare provider or automatically generated system notifications, the patient interface may also offer guidance on non-urgent matters, such as encouraging behaviours that may enhance cervical ripening. Additionally, the patient interface may include educational resources on cervical ripening and labor induction, along with options to share information with family members or on social media.

[0107] If desired, the different functions discussed herein may be performed in a different order and / or concurrently with other. Furthermore, if desired, one or more of the above-described functions and embodiments may be optional or may be combined.

[0108] Although various aspects of the embodiments are set out in the independent claims, other aspects comprise other combinations of features from the described embodiments and / or the dependent claims with the features of the independent claims, and not solely the combinations explicitly set out in the claims.

[0109] It is also noted herein that while the above describes example embodiments, these descriptions should not be viewed in a limiting sense. Rather, there are several variations and modifications, which may be made without departing from the scope of the present disclosure as defined in the appended claims, the present disclosure as defined in the appended claims.

Claims

Claims:1 . A labor induction and monitoring device (100), comprising:- a balloon catheter (101 ) configured to mechanically stimulate the cervix (128) for cervical ripening,- a sensor arrangement (114) comprising at least one sensor configured to obtain measurement data, said measurement data relating to fetal and / or maternal physiological parameters, uterine contraction, cervical ripening progression, and / or cervical balloon (108) expulsion, and- a control unit (116) configured to collect the measurement data and / or transmit the measurement data to an external device.

2. The labor induction and monitoring device of claim 1 , wherein the balloon catheter is a balloon catheter or a double balloon catheter.

3. The labor induction and monitoring device of claim 1 or 2, wherein the balloon catheter comprises an attachment system, adapted to receive attachment of the control unit.

4. The labor induction and monitoring device of claim 3, wherein the attachment system is configured to create an outward force directed from the uterus to accelerate the cervical ripening process.

5. The labor induction and monitoring device of claim 3 or 4, wherein the attachment system comprises an electrode.

6. The labor induction and monitoring device of any one of claims 1-5, wherein the sensor arrangement comprises at least one sensor attached to the balloon catheter, at least one abdominal sensor, at least one inguinal sensor, and / or at least one pelvic sensor.

7. The labor induction and monitoring device of any one of claims 1-6, wherein the sensor arrangement comprises at least one sensor attached to and / or integrated into the balloon catheter that is arranged at the proximal end, on the surface of the balloon catheter, and / or inside the balloon catheter.

8. The labor induction and monitoring device of any one of claims 1-7, wherein at least one sensor of the sensor arrangement is pre-attached to or pre-integrated into the balloon catheter.

9. The labor induction and monitoring device of any one of claims 1-8, wherein at least one sensor of the sensor arrangement is configured to be attached to or detached from the balloon catheter when the balloon catheter has been positioned in the patient.

10. The labor induction and monitoring device of any one of claims 1-9, wherein at least one sensor of the sensor arrangement is arranged to be coupled to the catheter via an injection port and / or a separate lumen in the balloon catheter.

11. The labor induction and monitoring device of any one of claims 1 -10, wherein the device is configured to provide a sensory indicator.

12. The labor induction and monitoring device of any one of claims 1 -11 , wherein the sensor arrangement is configured to obtain measurement data of fetal and / or maternal physiological parameters, which are at least one of fetal heart rate, fetal heart-rate variability, fetal movements, fetal temperature, maternal heart rate, maternal heart-rate variability, maternal movements, maternal temperature, maternal positions, uterine contractions, balloon position, and / or cervical ripening progression.

13. The labor induction and monitoring device of any one of claims 1 -12, wherein the sensor arrangement comprises a pressure sensor, and the pressure sensor is optionally a hydrophone, a microphone, a contactless sensor, and / or a membrane-coupled sensor.

14. The labor induction and monitoring device of any one of claims 1 -13, wherein the sensor arrangement comprises an intra-uterine Doppler and / or a biopotential sensor.

15. The labor induction and monitoring device of any one of claims 1 -14, wherein the sensor arrangement comprises at least one abdominal sensor, and the at least one abdominal sensor is configured to perform measurements based on at least one of electrocardiography, phonocardiography, seismocardiography, vibrocardiography, or Doppler ultrasound.

16. The labor induction and monitoring device of any one of claims 1 -15, wherein the sensor arrangement comprises at least one inguinal sensor, and the at least one inguinal sensor is configured to perform measurements based on at least one electromyography, electrocardiogram, pressure sensing, force sensing, impedance measurement, or ultrasound.

17. The labor induction and monitoring device of any one of claims 1 -16, wherein the sensor arrangement comprises at least one pelvic sensor, and the at least one pelvic sensor is configured to perform measurements based on at least one of electromyography, pressure sensing, force sensing, impedance measurement, or ultrasound.

18. The labor induction and monitoring device of any one of claims 1 -17, wherein the sensor arrangement comprises a temperature sensor.

19. The labor induction and monitoring device of any one of claims 1 -18, wherein the sensor arrangement comprises an inertial measurement unit and / or a motion sensor.

20. The labor induction and monitoring device of any one of claims 1 -19, wherein the control unit comprises at least one processor and at least one memory, including computer program code.

21. The labor induction and monitoring device of any one of claim 1 -20, wherein the external device is at least one of a remote processor, a mobile device, and / or a monitoring device.

22. The labor induction and monitoring device of any one of claims 1 -21 , wherein the device is battery-powered.

23. A labor induction and monitoring system, comprising:- a labor induction and monitoring device of any one of claims 1 -22, and- at least one external device, wherein the labor induction and monitoring device is configured to transmit the collected measurement data to at least one external device.

24. The labor induction and monitoring system of claim 23, wherein the labor induction and monitoring device is configured to transmit the collected measurement data to at least one external device utilizing long-range communication technologies, such as cellular networks.

25. The labor induction and monitoring system of claim 23, wherein the labor induction and monitoring device is configured to transmit the collected measurement data to a first external device utilizing short-range wireless communication technology, such as Bluetooth, and the first external device is configured to transmit the collected measurement data to a second external device utilizing long-range communication technologies, such as cellular networks.

26. The labor induction and monitoring system of claim 24, wherein the at least one external device comprises a mobile device, a remote processor, and / or a monitoring device.

27. The labor induction and monitoring system of claim 25, wherein the first external device is a mobile device, and the second external device is a remote processor and / or a monitoring device.

28. A method for monitoring labor induction, comprising:- collecting measurement data obtained via at least one sensor of a sensor arrangement of a labor induction device of any one of claims 1 -22, and- transmitting said measurement data to an external device.

29. A computer program product comprising computer program code configured to, when executed by at least one processor, cause a labor induction and monitoring system of any one of claims 23-27 to perform a method of claim 28.

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