System for assisting natural delivery of pregnant woman

Abstract

The invention relates to a system for assisting natural delivery of a pregnant woman, comprising: a fetal heart monitor for monitoring changes in uterine cavity pressure by means of a pressure probe placed on the abdominal wall of the pregnant woman during delivery; and the stimulation generator provides a stimulation signal corresponding to the change of the uterine cavity pressure provided by the fetal heart monitor according to the change of the uterine cavity pressure provided by the fetal heart monitor. The stimulation generator is provided with a communication unit, and the communication unit is used for obtaining uterine cavity pressure change signals related to a corresponding pregnant woman from the fetal heart monitor and providing the uterine cavity pressure change signals to a processing unit of the stimulation generator. A processing unit of the stimulation generator determines the generation opportunity, the intensity and the duration of the stimulation signal by analyzing the changes of the uterine cavity pressure. While providing a stimulation signal to guide a pregnant woman to perform correct breathing action, the device can relieve the pain of the lumbosacral part of the pregnant woman by means of the stimulation signal, and while relieving the discomfort of the lumbosacral part, the device contributes to the synergistic effect of waist and abdomen muscles of the pregnant woman so as to promote natural childbirth.

Description

Technical Field

[0001] The present invention relates to the technical field of childbirth assistance, and particularly relates to a system for assisting pregnant women in natural childbirth. Background Art

[0002] In the early stage of childbirth, that is, in the initial stage of labor, pregnant women will experience regular uterine contractions, which are accompanied by rapid changes in the intrauterine pressure (uterine pressure), forming significant peaks. During this period, the peak uterine pressure is usually in the range of 50 to 70 millimeters of mercury (mmHg). Since the intensity is relatively low, the discomfort caused to pregnant women is not obvious. According to the numerical rating scale (NRS) system assessment, the pain level at this time is roughly between 3 and 5.

[0003] As the childbirth process progresses, during the active phase, the regular uterine contractions not only increase in frequency, but also the peak pressure in the uterine cavity during each contraction can significantly increase to exceed 100 mmHg, and the duration of each contraction also extends to 60 to 90 seconds. The intensity of uterine contractions in this stage increases significantly, resulting in a sharp rise in the pain level felt by pregnant women. According to the NRS scoring standard, the pain intensity can reach the highest level, that is, 10.

[0004] During this process, the professional guidance of midwives is crucial. Midwives can provide scientific and effective guidance on breathing techniques to help pregnant women adapt to the pain caused by uterine contractions and assist pregnant women in adjusting their breathing patterns according to the rhythm of uterine contractions to form physiological reactions conducive to natural childbirth. Without professional guidance, pregnant women may spontaneously try to relieve pain by changing their breathing frequency and rhythm. However, these unguided methods often cannot fully adapt to the changes in uterine contractions, which may affect the safety and efficiency of childbirth and increase the uncertainty and risks during the natural childbirth process.

[0005] In addition, in the early, middle, and late stages of childbirth and after childbirth, pregnant women may experience pain symptoms in the lumbosacral region, manifested as soreness and weakness in the lumbosacral region and buttocks, limited lumbar movement, tenderness in the paravertebral region, sacroiliac joint, and gluteus medius region. This pain may be due to the relaxation of the pelvic and lumbar ligaments caused by hormonal changes during pregnancy, an increase in pelvic width to provide more space for the fetus. At the same time, the forward shift of the center of gravity brought about by the growth of the fetus causes pelvic anteversion, which compresses the lumbar spine and lumbar neuromuscles, further exacerbating the symptoms of low back pain during childbirth. In view of the above situation, taking appropriate preventive measures and relief means is of great significance for reducing the pain of pregnant women and ensuring smooth childbirth.

[0006] CN116785110A discloses a clinical auxiliary natural childbirth device, which realizes the autonomous adjustment of the opening and closing degree of the parturient's hip joint through the combination of mechanical structures such as a limit platform, a delivery bed and its internal components, and can relieve the degree of effort of the parturient. The device is also provided with a guiding component and a pressure component, which can guide and adjust the breathing frequency of the parturient during the delivery process.

[0007] However, the device in this literature mainly focuses on the design of the mechanical structure and lacks the direct monitoring of the changes in the intrauterine pressure (uterine pressure) during uterine contractions. It does not provide the function of adjusting the stimulation signal according to the changes in uterine pressure or guiding the pregnant woman to perform corresponding breathing actions, which may lead to the failure to fully respond to the dynamic needs during the actual application of childbirth. In addition, this literature does not describe in detail how to deal with the pain problem during childbirth, especially in the face of different degrees of pain caused by uterine contractions of different intensities, and it lacks targeted solutions. This means that in the case of high-intensity uterine contractions, relying solely on pressure to guide breathing may not be sufficient to effectively relieve the pain of the pregnant woman, thereby affecting the childbirth experience.

[0008] In addition, on the one hand, there are differences in the understanding of those skilled in the art; on the other hand, although the applicant has studied a large number of literatures and patents when making this invention, due to space limitations, all details and contents are not listed in detail. However, this does not mean that this invention does not possess the features of these prior arts. On the contrary, this invention already possesses all the features of the prior arts, and the applicant reserves the right to add relevant prior arts in the background art. Summary of the Invention

[0009] In order to solve the problem that pregnant women without training cannot cooperate with regular uterine contractions to perform breathing actions that can combat pain and contribute to natural childbirth, the present invention proposes a system for assisting pregnant women in natural childbirth. This system can, while providing a stimulation signal to guide the breathing action, also relieve the pain in the lumbosacral region of the pregnant woman by means of the stimulation signal. While relieving the discomfort in the lumbosacral region, it helps the synergistic action of the lumbar and abdominal muscles to promote natural childbirth. In addition, the system of the present invention also aims to guide pregnant women to master the characteristics of regular uterine contractions so as to breathe and move correctly to avoid the risks of fetal distress and amniotic fluid contamination.

[0010] The present invention discloses a system for assisting pregnant women in natural childbirth, comprising: a fetal heart monitor, which is used to monitor the change of intrauterine pressure during childbirth by means of a pressure probe placed on the abdominal wall of the pregnant woman; a stimulation generator, which provides a stimulation signal consistent with the change of intrauterine pressure provided by the fetal heart monitor; the stimulation generator has a communication unit, the communication unit is used to obtain the intrauterine pressure change signal related to the corresponding pregnant woman from the fetal heart monitor, and provide the intrauterine pressure change signal to the processing unit of the stimulation generator, and the processing unit of the stimulation generator determines the occurrence timing, intensity and duration of the stimulation signal by analyzing the change of intrauterine pressure.

[0011] The system of the present invention customizes the stimulation signal according to the specific situation of each pregnant woman (such as the change of intrauterine pressure). The system provides personalized analgesia and breathing guidance, thereby improving the quality of the childbirth experience. This personalized method can better adapt to the needs of different individuals. By guiding pregnant women to master the characteristics of regular uterine contractions, they can breathe and move correctly to avoid the risks of fetal distress and amniotic fluid contamination, and improve the comfort during childbirth. In addition, the system automatically processes and responds to intrauterine pressure data, reducing the need for frequent manual intervention by medical staff, saving labor costs while ensuring the consistency and accuracy of the stimulation parameter settings.

[0012] According to a preferred embodiment, the stimulation generator includes a stimulation unit communicatively connected to the processing unit. The stimulation unit performs specific stimulation actions according to the instructions issued by the processing unit to assist pregnant women in managing pain and breathing rhythm during childbirth. Among them, the stimulation unit can apply current stimulation with different pulse intensities by means of an electrical stimulation module, and / or apply physical vibration stimulation with different frequencies and amplitudes by means of a massage stimulation module. The stimulation unit dynamically adjusts the stimulation parameters (such as current intensity, vibration frequency and amplitude) according to the real-time analysis results of the processing unit on the change of intrauterine pressure, so as to achieve an immediate response to each uterine contraction event. This precise control ensures a high degree of synchronization between the stimulation signal and the uterine contraction activity, enhancing the effects of analgesia and breathing guidance. The system can automatically adjust the stimulation mode according to the specific situation of different pregnant women, providing a personalized support plan for each user, enhancing the adaptability of the system and the comfort of the user. In addition, by closely monitoring the fetal heart rate and intrauterine pressure and adjusting the stimulation strategy in a timely manner, the system can protect the health of the fetus while ensuring the comfort of the parturient, reducing the adverse effects caused by excessive tension or pain, such as complications such as fetal distress.

[0013] According to a preferred embodiment, the processing unit of the stimulation generator determines the slope and duration of the change in uterine pressure at each time point by determining the characteristics of the change in uterine pressure over time. When it detects that the change in uterine pressure meets the preset conditions, the processing unit generates one of the matching inspiration stimulation signals, expiration stimulation signals, pain relief stimulation signals, or analgesic stimulation signals to instruct the stimulation unit to set the stimulation parameters of the electrical stimulation module and / or the massage stimulation module. The built-in algorithm of the processing unit analyzes the intrauterine pressure data received from the communication unit, calculates the rising or falling slope of the uterine pressure at each time point, and records its duration. This high-precision data analysis ensures the accurate capture of changes in uterine pressure. Once the change in uterine pressure reaches the preset conditions, the processing unit immediately generates the corresponding stimulation signal instruction. This enables the system to quickly respond to uterine contraction events and provide timely and effective breathing guidance and pain management. In addition, according to different stages of the change in uterine pressure (such as the start of uterine contractions, the peak of uterine contractions, and the end of uterine contractions), the processing unit dynamically adjusts the occurrence time, intensity, and duration of the stimulation signal. This flexibility ensures that the stimulation is both effective and safe, optimizing the childbirth experience.

[0014] According to a preferred embodiment, when the processing unit detects that the rising slope of the uterine pressure reaches its preset starting slope, the processing unit generates a signaling for generating an inspiration stimulation signal and sends it to the stimulation unit to guide the inspiration action. The processing unit analyzes the intrauterine pressure data received from the communication unit through a built-in algorithm and calculates the rising slope of the uterine pressure at each time point. This high-precision data analysis ensures the accurate capture of the start of uterine contractions.

[0015] According to a preferred embodiment, when the processing unit detects that the falling slope of the uterine pressure reaches its preset stopping slope, the processing unit generates a signaling for generating an expiration stimulation signal and sends it to the stimulation unit to guide the expiration action. The processing unit analyzes the intrauterine pressure data received from the communication unit through a built-in algorithm and calculates the falling slope of the uterine pressure at each time point. Once the falling slope of the uterine pressure reaches the preset stopping slope, the processing unit immediately generates a signaling for generating an expiration stimulation signal. This enables the system to quickly respond in the initial stage of uterine contractions and provide timely and effective breathing guidance.

[0016] According to a preferred embodiment, when the processing unit detects that the rising slope of the uterine pressure exceeds the starting slope and the uterine pressure is greater than a preset first threshold, the processing unit can identify it as a signal for the start of a uterine contraction that requires pain relief support, generate a signaling for generating a pain relief stimulation signal, and send it to the stimulation unit to relieve the pain of uterine contractions. The pain relief stimulation signal uses a significantly stronger stimulation amplitude or intensity to distract and reduce the pain sensation, and is applicable to the situation where the uterine pressure is greater than the first threshold. This approach helps to provide additional support during the peak of uterine contractions and helps the pregnant woman better cope with severe pain.

[0017] According to a preferred embodiment, when the processing unit detects that the intrauterine pressure is greater than a preset second threshold, the processing unit recognizes this as a signal of a strong uterine contraction, generates a signaling for generating an analgesic stimulation signal, and sends it to the stimulation unit to relieve the uterine contraction pain. Among them, if the intrauterine pressure is greater than the second threshold and lasts for more than a preset duration, the processing unit generates a prompt instruction for reminding of pharmacological analgesia and sends it to an external display unit through the communication unit. If the intrauterine pressure is greater than the preset second threshold, it means that the pregnant woman is about to or is experiencing a situation where pain relief by only breathing regulation and pain relief stimulation is not sufficient. The step of the processing unit automatically generating a signaling for generating an analgesic stimulation signal and sending it to the stimulation unit realizes the automation of analgesic measures, reduces manual intervention, and improves the efficiency and accuracy of pain management. In addition, the pharmacological analgesia prompt aims to assist medical staff in taking accurate medical intervention measures in a timely manner to ensure that the pregnant woman obtains the necessary pharmacological analgesia support.

[0018] According to a preferred embodiment, the inspiration stimulation acts on the pregnant woman through a gradually increasing stimulation amplitude and / or intensity to simulate the feeling of deep inspiration; the expiration stimulation acts on the pregnant woman through a gradually decreasing stimulation amplitude and / or intensity to guide her to perform a gentle expiration action; the pain relief stimulation uses a stronger stimulation amplitude or intensity than the inspiration stimulation and the expiration stimulation to distract attention and relieve pain; the analgesic stimulation further increases the stimulation amplitude or intensity on the basis of the pain relief stimulation. The system of the present invention realizes effective intervention in the breathing and pain management of pregnant women by selecting different types of stimulation modes. The inspiration stimulation and the expiration stimulation help to guide the pregnant woman to perform correct breathing exercises, achieving physical and mental relaxation and balance; the pain relief stimulation and the analgesic stimulation provide a new method for pain management for the pregnant woman by distracting attention and activating the pain relief mechanism. These stimulation modes complement each other and jointly constitute a comprehensive and effective breathing and pain management system for pregnant women.

[0019] According to a preferred embodiment, when generating the expiration stimulation signal, the inspiration stimulation signal, the analgesic stimulation signal, and the pain relief stimulation signal, the processing unit can obtain the change in fetal heart rate from the fetal heart monitor and use it to generate or stop the corresponding stimulation and / or generate corresponding prompt information for the external display unit. The processing unit can obtain the change in fetal heart rate from the fetal heart monitor in real time. This real-time nature ensures that the generation or stop of the stimulation signal can quickly respond to the change in fetal heart rate, thereby improving the accuracy and effectiveness of the stimulation. This is crucial for the safety of the pregnant woman and the fetus because timely stimulation adjustment can avoid potential adverse effects.

[0020] According to a preferred embodiment, the processing unit can introduce a phased adjustment scheme for the stimulation unit according to the change of the fetal heart rate. Based on the specific change of the fetal heart rate, the processing unit instructs the electrical stimulation module and / or the massage stimulation module in the stimulation unit to adjust the corresponding stimulation parameters, so that the stimulation generator operates according to the adjustment scheme of different stages. This intelligent adjustment mechanism makes the application of the stimulation signal more personalized and customized, and can be flexibly adjusted according to the specific conditions of different pregnant women and fetuses. This helps to improve the pertinence and effectiveness of the stimulation, while reducing unnecessary stimulation. Description of the Drawings

[0021] Figure 1 is a schematic diagram of the usage scenario of the system for assisting pregnant women in natural childbirth provided by the present invention;

[0022] Figure 2 is the hardware connection diagram of the system for assisting pregnant women in natural childbirth provided by the present invention;

[0023] Figure 3 is the example block diagram of the system for assisting pregnant women in natural childbirth provided by the present invention;

[0024] Figure 4 is the working flow chart of the system for assisting pregnant women in natural childbirth provided by the present invention;

[0025] Figure 5 is the CST graph of a pregnant woman at the initial stage of labor provided by the present invention;

[0026] Figure 6 is the CST graph of a pregnant woman at the active stage of labor provided by the present invention;

[0027] Figure 7 is the CST graph of a pregnant woman when the cervix is fully dilated provided by the present invention;

[0028] Figure 8 is the CST graph of the start to end of a standard uterine contraction provided by the present invention.

[0029] List of Reference Numerals

[0030] 100: Fetal heart monitor; 110: Pressure probe; 200: Stimulation generator; 210: Communication unit; 220: Processing unit; 230: Stimulation unit; 231: Electrical stimulation module; 232: Massage stimulation module; 300: Display unit. Detailed Description of the Invention

[0031] The following is a detailed description with reference to the drawings.

[0032] Example 1

[0033] The present invention relates to a system for assisting natural childbirth of pregnant women, which includes a fetal heart monitor 100 and a stimulation generator 200.

[0034] As Figure 1 shown, the fetal heart monitor 100 is a commonly used device in the hospital delivery room environment. It monitors the pressure changes in the uterine cavity through a highly sensitive pressure probe 110. The probe is usually made of flexible silicone material to ensure good biocompatibility and wearing comfort. At the same time, it is equipped with an adjustable adhesive band or fixing band, and medical staff can adjust it appropriately according to the pregnant woman's body shape and abdominal contour to ensure that the pressure probe 110 can closely fit the pregnant woman's abdominal wall without causing discomfort, thereby ensuring the best signal acquisition quality. The fetal heart rate measurement range of the fetal heart monitor 100 is usually in the range of 30 - 250 bpm, and the measurement accuracy can reach ≤±1 bpm; this means that the fetal heart monitor 100 can accurately measure the fetal heart rate in beats per minute (bpm). The fetal heart monitor 100 can also measure the uterine pressure at the same or at least a similar sampling frequency, thereby being able to accurately measure the slope of the uterine pressure change. The fetal heart monitor 100 can not only capture the uterine pressure fluctuations in real time, but also immediately analyze the collected information and visually display it to medical staff through a graphical interface to promptly detect any potential risk factors.

[0035] Preferably, as Figure 2 shown, the stimulation generator 200 integrates multiple parts such as a communication unit 210, a processing unit 220, and a stimulation unit 230. Among them, the communication unit 210 is responsible for data interaction with the fetal heart monitor 100; the processing unit 220 undertakes the tasks of data analysis and instruction generation; and the stimulation unit 230 performs specific physical or electrical stimulation actions according to the instructions issued by the processing unit 220 to assist the pregnant woman in managing pain and breathing rhythm during childbirth.

[0036] The communication unit 210, as a bridge for signal transmission, is responsible for obtaining the uterine cavity pressure change signal from the fetal heart monitor 100. To ensure the reliability and accuracy of data transmission, it can be composed of one or more wireless communication modules (such as Bluetooth Low Energy BLE, Wi-Fi, Zigbee, etc.) and / or wired interfaces (such as USB, RS232 serial interface), ensuring the security, reliability, and real-time nature of data transmission. The communication unit 210 establishes a two-way communication link with the fetal heart monitor 100 through a standard protocol, not only receiving the uterine pressure change signal, but also sending control instructions to the fetal heart monitor 100, such as requesting a specific data update frequency or synchronizing timestamps.

[0037] The processing unit 220 can be a high-performance processor, which can be built based on a microcontroller (MCU), a digital signal processor (DSP), or an embedded computer system. It is equipped with sufficient memory (RAM / Flash) to run complex algorithms and has built-in high-speed computing capabilities to quickly analyze the characteristics of uterine pressure changes over time, including but not limited to the rising slope, falling slope, peak detection, etc. The processing unit 220 determines the occurrence timing, intensity, and duration of the stimulation signal according to preset rules and generates corresponding signaling to control the working state of the stimulation unit 230. In addition, the processing unit 220 can also process other physiological parameters (such as fetal heart rate) from the fetal monitor 100 to further optimize the stimulation strategy.

[0038] As Figure 2 shown, the stimulation unit 230 can be equipped with an electrical stimulation module 231 and a massage stimulation module 232, aiming to provide pain management and breathing guidance support for pregnant women through these two non-invasive technologies. The two modules optimize the analgesic effect during childbirth based on the real-time monitored changes in uterine pressure, while ensuring safety and comfort. Specifically, the stimulation unit 230 has two functions. One is to guide the correct breathing movements to relieve pain; the other is to relieve pain to a certain extent using external force. During uterine contractions, the stimulation unit 230 can selectively provide specific transcutaneous electrical nerve stimulation (TENS) or massage stimulation signals to guide pregnant women to perform deep inhalation and slow exhalation breathing movements to counteract pain. These stimulation signals are designed to help pregnant women establish an effective breathing pattern and use breathing regulation techniques to reduce the pain during childbirth. When the uterine contraction pain reaches or exceeds a certain threshold (for example, the NRS score reaches a relatively high level), relying solely on breathing regulation may not be sufficient to fully relieve the pain. At this time, the stimulation unit 230 will further take the way of electrical stimulation and mechanical massage stimulation to directly intervene and provide additional analgesic support for pregnant women.

[0039] Preferably, the inhalation movement of the pregnant woman to counteract pain is, for example, deep inhalation, and the exhalation movement is slow exhalation. These two breathing patterns refer to the Lamaze breathing method, and are detailedly guided by midwives for pregnant women during their hospitalization before childbirth to ensure that they can correctly perform these movements after the stimulation unit 230 gives corresponding stimuli.

[0040] Preferably, the electrical stimulation module 231 of the stimulation unit 230 adopts transcutaneous electrical nerve stimulation (TENS) technology, which applies current pulses within a safe range through one or more pairs of highly sensitive electrode patches to help relieve pain during childbirth. This module can not only automatically adjust the current intensity and frequency during uterine contractions to meet the needs of different stages and provide the most suitable pain relief and analgesia, but is also specially designed to guide pregnant women to perform correct breathing movements of deep inhalation and slow exhalation to enhance their own ability to fight pain. The electrode patch is made of disposable medical grade flexible material with good biocompatibility and conductivity, ensuring that it fits closely to the surface of the pregnant woman's skin without causing discomfort or allergic reactions. Preferably, each patch can also be equipped with a built-in micro sensor for real-time monitoring of skin resistance changes, thereby optimizing current output parameters and improving the safety and effectiveness of stimulation. According to a study published by Piasecki et al. in the Scandinavian Journal of Pain in 2023, high-frequency, high-intensity TENS has been shown to be effective in pain management, especially in analgesia after gynecological surgery, which further verifies the scientific basis for the application of this module during delivery.

[0041] In order to more effectively guide the correct breathing action, when the uterine contraction begins, the electrical stimulation module 231 will generate a progressive current pulse to simulate the feeling of deep inhalation, prompting the pregnant woman to inhale deeply and slowly; when the uterine pressure drops, the module will send out a gradually weakening current pulse to guide the pregnant woman to exhale slowly. This breathing guidance mechanism can help pregnant women maintain a stable breathing rhythm, reduce tension during delivery, and enhance their ability to self-regulate pain.

[0042] Preferably, if Figure 1 As shown, the massage stimulation module 232 of the stimulation unit 230 includes a small electric or pneumatic vibration device that can generate physical vibrations of different frequencies (such as 50 to 200 Hz) and amplitudes, simulating the techniques of professional masseurs, and effectively reducing the soreness in the lumbar and sacral regions and buttocks. The module supports multi-mode vibration settings and can be flexibly adjusted according to user needs to provide pregnant women with a personalized comfort experience. The vibration device is mounted on an adjustable support frame, allowing medical staff to adjust the position according to the body shape and preferences of the pregnant woman to ensure the best contact point and massage effect. In addition, the module housing is made of antibacterial material, which is easy to clean and disinfect to ensure sanitary conditions. A study published by Baxter et al. in Frontiers in Pain Research in 2023 pointed out that multimodal mechanical stimulation significantly reduced the pain scores of patients with acute and chronic lower back pain, which provided a theoretical basis and support for the use of this module during delivery.

[0043] In terms of breathing guidance during uterine contractions, the massage stimulation module 232 focuses vibrations with a lower frequency but stronger amplitude around the lumbosacral region. By increasing the body's sensory input, it prompts the pregnant woman to take deeper inhalation actions. While relieving the discomfort in the lumbosacral region, it helps the muscles in her waist and abdomen to work together to facilitate natural childbirth. As the uterine pressure drops, the massage stimulation module 232 switches to vibrations with a higher frequency but weaker amplitude, covering a wider area, which helps to distract attention, makes the pregnant woman feel more relaxed, and encourages them to slowly complete the exhalation action.

[0044] Preferably, the two modules of the stimulation unit 230 are connected to the processing unit 220 through a high-speed internal bus or a dedicated communication line to receive precise control commands from the processing unit 220 and execute specific stimulation tasks. This design not only improves the system's response speed and accuracy but also ensures continuous and safe auxiliary support throughout the childbirth process.

[0045] Preferably, as Figure 2 , Figure 3 shown, the processing unit 220 of the stimulation generator 200 determines the slope and time of the uterine pressure change by determining the characteristics of the uterine pressure change over time. Specifically, the processing unit 220 first obtains the monitored intrauterine pressure data from the communication unit 210 through a high-speed internal bus or a dedicated communication line. The algorithm built into the processing unit 220 analyzes the uterine pressure change in detail, calculates the uterine pressure slope at each time point (rising or falling, representing the intensity of the uterine contraction change), and records its duration. When it is detected that the rising slope of the uterine pressure exceeds the starting slope (such as +3 to 5 mmHg / s, which can be adaptively set according to the clinical experience of medical staff), the processing unit 220 identifies this as a signal indicating the start of a uterine contraction; conversely, when the falling slope of the uterine pressure exceeds the stopping slope (such as -3 to 5 mmHg / s, which can be adaptively set according to the clinical experience of medical staff), it is regarded as a sign of the end of a uterine contraction.

[0046] As Figure 4 shown, once the rising slope of the uterine pressure reaches the starting slope, the processing unit 220 immediately generates a signaling for generating an inhalation stimulation signal. This signaling is transmitted to the electrical stimulation module 231 of the stimulation unit 230 through the internal bus, instructing it to execute a progressively enhanced current pulse output, and / or transmitted to the massage stimulation module 232 of the stimulation unit 230, instructing it to provide vibrations with a lower frequency (such as 50 to 80 Hz) but stronger amplitude (such as 2 to 4 mm) concentrated around the lumbosacral region, guiding the pregnant woman to perform an inhalation action against pain by simulating the feeling of deep inhalation.

[0047] As Figure 4As shown, when the decline slope of the uterine pressure reaches the stop slope, the processing unit 220 generates a signaling for generating an exhalation stimulation signal. At this time, the electrical stimulation module 231 of the stimulation unit 230 adjusts to an output of gradually decreasing current pulses according to the instruction, and / or the massage stimulation module 232 of the stimulation unit 230 adjusts to a vibration with a higher frequency (such as 150 - 200 Hz) but a weaker amplitude (such as 0.5 - 1.5 mm) according to the instruction, instructing the pregnant woman to perform a soothing exhalation action.

[0048] Preferably, the inhalation stimulation and the exhalation stimulation are significantly different in form, ensuring that the pregnant woman can clearly distinguish and be guided to the correct breathing rhythm.

[0049] Preferably, as Figure 4 shown, when the processing unit 220 of the stimulation generator 200 detects that the rise slope of the uterine pressure exceeds the start slope and the uterine pressure is greater than the first threshold (such as 70 mmHg), this means that the pregnant woman is about to or is experiencing a stronger uterine contraction where breathing regulation alone is not sufficient to fully relieve the pain. The processing unit 220 can identify this as a signal indicating the start of a uterine contraction that requires pain relief support. Under the above conditions, the processing unit 220 immediately generates a signaling for generating a pain relief stimulation signal. This signaling is transmitted to the stimulation unit 230 through the internal bus, instructing it to perform mechanical massage stimulation and / or electrical stimulation that is significantly different from the inhalation stimulation and the exhalation stimulation, helping to distract and relieve the pain of the pregnant woman. After the pain relief stimulation has passed a preset duration, only when the processing unit 220 determines that the decline slope of the uterine pressure exceeds the stop slope and the uterine pressure is less than the first threshold, the processing unit 220 generates a signaling for generating an exhalation stimulation signal, using the electrical stimulation module 231 and / or the massage stimulation module 232 to instruct the pregnant woman to perform a soothing exhalation action.

[0050] The determination of this preset duration needs to consider the uterine contraction cycle, physiological response time, safety, and comfort. Normally, the duration of a single uterine contraction is 60 - 90 s. Therefore, the pain relief stimulation should provide sufficient support at the peak of the uterine contraction. Considering the human body's perception and adaptation time to the stimulation, it usually takes a few seconds to establish an effective analgesic effect. Continuous stimulation for too long may cause discomfort or over - dependence, while too short may not be sufficient to effectively relieve the pain. Considering the above factors, a reasonable "preset duration" can be set to 30 - 60 s. This time period can ensure sufficient pain relief support at the peak of the uterine contraction without causing unnecessary long - term stimulation, thus ensuring the safety of the system and the comfort of the pregnant woman.

[0051] Preferably, as Figure 4As shown, when the processing unit 220 of the stimulation generator 200 detects that the uterine pressure is greater than the second threshold (such as 100 mmHg), the processing unit 220 recognizes this as a signal of a strong uterine contraction, meaning that the pregnant woman is about to or is experiencing a situation where pain relief by only breathing regulation and pain relief stimulation is not sufficient to fully relieve the pain. Under the above conditions, the processing unit 220 immediately generates a signaling for generating an analgesic stimulation signal. This signaling is transmitted to the stimulation unit 230 through the internal bus, instructing it to perform high-intensity electrical stimulation or mechanical massage to provide additional analgesic assistance to the pregnant woman. Further, the processing unit 220 continues to monitor the change in uterine pressure. When it is determined that the current uterine pressure of the pregnant woman is greater than the second threshold and lasts for more than a predetermined duration (such as 60 - 90 s, and the specific value should be adjusted according to clinical experience and individual differences), the processing unit 220 generates a prompt instruction for reminding of pharmacological analgesia. This prompt instruction is sent to the external display unit 300 through the communication unit 210, preferably sent to the fetal heart monitor 100 for providing uterine pressure, to display a pharmacological analgesia prompt related to the excessive duration of the uterine pressure exceeding the limit. Such a prompt is intended to assist medical staff in taking accurate medical intervention measures in a timely manner to ensure that the pregnant woman obtains necessary pharmacological analgesia support.

[0052] Preferably, the inhalation stimulation acts on the pregnant woman through a gradually increasing stimulation amplitude and / or intensity to simulate the feeling of deep inhalation; while the exhalation stimulation acts on the pregnant woman through a gradually decreasing stimulation amplitude and / or intensity to guide her to perform a slow exhalation action. In addition, compared with the inhalation stimulation and exhalation stimulation, the pain relief stimulation uses a significantly stronger stimulation amplitude or intensity to distract and relieve the pain; while the analgesic stimulation further increases the stimulation intensity to provide a more significant analgesic effect.

[0053] Specifically, for the electrical stimulation module 231, when the rising slope of the uterine pressure exceeds the starting slope, the processing unit 220 generates a signaling for generating an inhalation stimulation signal, which can be sent to the electrical stimulation module 231 to instruct the electrode patch to emit gradually increasing current pulses. The initial current intensity can be set to 1 mA and linearly increase to about 3 mA within a few seconds to help the pregnant woman concentrate and prepare for the next exhalation action. On the contrary, when the falling slope of the uterine pressure exceeds the stopping slope, the processing unit 220 generates a signaling for generating an exhalation stimulation signal, instructing the electrode patch to emit gradually decreasing current pulses, gradually decreasing from 3 mA back to 1 mA, simulating the process of slow exhalation, guiding the pregnant woman to relax the abdominal muscles and slowly exhale the air.

[0054] When the rising slope of the uterine pressure exceeds the starting slope and the uterine pressure is greater than the first threshold, the processing unit 220 generates a signaling for generating a pain-relieving stimulation signal, which can be sent to the electrical stimulation module 231 to instruct the electrode patch to apply a medium-intensity current pulse, such as 4-6 mA, with a duration of 30-60 s. This relatively high current intensity is applicable to the situation where the pregnant woman is about to experience or is experiencing strong uterine contractions. It can effectively distract the pregnant woman's attention and relieve pain without causing excessive discomfort.

[0055] When the uterine pressure exceeds the second threshold, the processing unit 220 generates a signaling for generating an analgesic stimulation signal, which can be sent to the electrical stimulation module 231 to instruct the electrode patch to apply a higher-intensity current pulse, such as 8-12 mA, to provide a more significant analgesic effect. This high-intensity current pulse can provide additional support to the pregnant woman during strong uterine contractions, ensuring her comfort and safety.

[0056] For the massage stimulation module 232, when the rising slope of the uterine pressure exceeds the starting slope, the processing unit 220 generates a signaling for generating an inhalation stimulation signal, which can be sent to the massage stimulation module 232 to instruct the small vibration device to provide a vibration with a lower frequency but a stronger amplitude, concentrated around the lumbosacral region, increasing the body's sensory input and prompting the pregnant woman to take a deeper inhalation action. The specific parameters can be set to a vibration frequency of 60 Hz and an amplitude of about 3 mm, ensuring that the vibration intensity is obvious enough to attract the pregnant woman's attention and promote the deep inhalation action, but not overly stimulating.

[0057] When the rising slope of the uterine pressure exceeds the starting slope and the uterine pressure is greater than the first threshold, the processing unit 220 generates a signaling for generating a pain-relieving stimulation signal, which can be sent to the massage stimulation module 232 to instruct the small vibration device to switch to a vibration mode with a higher frequency but a weaker amplitude, covering a wider area, helping the pregnant woman feel more relaxed and encouraging them to slowly complete the exhalation action. The specific parameters can be set to a vibration frequency of 180 Hz and an amplitude of about 1 mm, ensuring that the vibration is gentle and does not interfere with the pregnant woman's relaxed state, while still providing sufficient tactile feedback to relieve the uterine contraction pain.

[0058] When the uterine pressure exceeds the second threshold, the processing unit 220 generates a signaling for generating an analgesic stimulation signal, which can be sent to the massage stimulation module 232 to instruct the small vibration device to provide a vibration with a higher frequency but a stronger amplitude to provide a more significant analgesic effect. The specific parameters can be set to a vibration frequency of 150 Hz and an amplitude of about 4 mm. This high-intensity vibration can provide additional support to the pregnant woman during strong uterine contractions, ensuring her comfort and safety.

[0059] In summary, by combining electrical stimulation and mechanical massage, the stimulation generator 200 can provide scientific and effective breathing guidance and support for pregnant women at different stages of childbirth. The inhalation stimulation and exhalation stimulation respectively simulate the sensations of deep inhalation and slow exhalation, helping pregnant women maintain a stable breathing rhythm; the pain relief stimulation and analgesic stimulation provide additional pain management support when necessary to ensure the comfort and safety of pregnant women throughout the childbirth process.

[0060] Preferably, as Figure 3 shown, when generating the exhalation stimulation signal, inhalation stimulation signal, analgesic stimulation signal, and pain relief stimulation signal, the processing unit 220 also obtains the change in fetal heart rate from the fetal heart rate monitor 100 and uses it to generate or stop the corresponding stimulation and / or generate corresponding prompt information for the external display unit 300. The change in fetal heart rate is one of the important indicators for evaluating the health status of the fetus, which directly reflects the response and adaptability of the fetus in the intrauterine environment. The change in fetal heart rate can reflect whether the fetus is in a stress state or at risk of hypoxia. For example, when the fetal heart rate continuously and abnormally increases or shows abnormal deceleration, this may be a signal that the fetus is facing stress or insufficient oxygen supply. At this time, if the intensity of electrical stimulation or mechanical massage is insufficient, the uterine contraction situation of the pregnant woman may not be effectively relieved, thereby indirectly affecting uterine blood flow and causing insufficient oxygen supply to the fetus.

[0061] Preferably, in order to manage pain more precisely and ensure the safety and comfort of the mother and baby, the processing unit 220 can introduce a phased adjustment plan for the stimulation unit 230 according to the change in fetal heart rate. According to the change in fetal heart rate, the adjustment plan can be set to include three stages.

[0062] When the fetal heart rate begins to show a slight increase (for example, exceeding 140 bpm but not reaching 160 bpm), in response to the uterine cavity pressure and fetal heart rate change signals sent by the fetal heart monitor 100 to the communication unit 210, the processing unit 220 can instruct the electrical stimulation module 231 and / or the massage stimulation module 232 of the stimulation unit 230 to set corresponding stimulation parameters so that the stimulation generator 200 adopts the adjustment scheme of the first stage. When the fetal heart rate further increases (for example, exceeding 160 bpm), in response to the uterine cavity pressure and fetal heart rate change signals sent by the fetal heart monitor 100 to the communication unit 210, the processing unit 220 can instruct the electrical stimulation module 231 and / or the massage stimulation module 232 of the stimulation unit 230 to set corresponding stimulation parameters so that the stimulation generator 200 adopts the adjustment scheme of the second stage. When the fetal heart rate remains at a high level for a long time (such as exceeding 160 bpm for more than 3 minutes), in response to the uterine cavity pressure and fetal heart rate change signals sent by the fetal heart monitor 100 to the communication unit 210, on the one hand, the processing unit 220 can instruct the electrical stimulation module 231 and / or the massage stimulation module 232 of the stimulation unit 230 to set corresponding stimulation parameters so that the stimulation generator 200 adopts the adjustment scheme of the third stage, and on the other hand, instruct the communication unit 210 to send a drug analgesia prompt to the external display unit 300 or the fetal heart monitor 100 to display the drug analgesia prompt related to the excessive duration of uterine pressure exceeding the limit. This prompt aims to assist medical staff in taking accurate medical intervention measures in a timely manner to ensure that pregnant women obtain the necessary drug analgesia support. At this time, the stimulation parameters of the electrical stimulation module 231 and / or the massage stimulation module 232 can be restored to the level of the first stage to reduce the additional stimulation to the pregnant woman.

[0063] Preferably, in the adjustment scheme of the first stage, for the inhalation stimulation signal and the exhalation stimulation signal, the current intensity of the electrical stimulation module 231 still linearly varies within 1 - 3 mA, but by slightly accelerating the speed of linear increase and decrease, it can more quickly guide the pregnant woman to perform the inhalation and exhalation actions. At the same time, the vibration frequency of the massage stimulation module 232 is slightly increased to about 70 Hz, and the amplitude is maintained at 3 mm to ensure that the vibration intensity is obvious enough to attract the attention of the pregnant woman and promote deep inhalation, but not overly stimulating.

[0064] For the pain relief stimulation signal, the current intensity of the electrical stimulation module 231 is finely adjusted to be close to the upper limit (such as 5 - 6 mA) to enhance the effect of distracting attention; while the amplitude of the massage stimulation module 232 is slightly increased to about 1.2 mm to strengthen the gentle massage feeling and further relieve pain.

[0065] In response to the analgesic stimulation signal, the electrical stimulation module 231 applies a medium-strength current pulse (e.g., 4 - 6 mA) for a duration of 30 - 60 seconds. This relatively high current intensity is suitable for situations where a pregnant woman is about to experience or is already experiencing relatively strong uterine contractions. It can effectively distract the pregnant woman and relieve pain without causing excessive discomfort. At the same time, the massage stimulation module 232 switches to a vibration mode with a higher frequency but a weaker amplitude (e.g., a vibration frequency of 180 Hz and an amplitude of approximately 1 mm), covering a wider area, helping the pregnant woman feel more relaxed, encouraging them to slowly complete the exhalation action, and providing sufficient tactile feedback to relieve uterine contraction pain.

[0066] Preferably, in the adjustment plan for the second stage, for the inhalation stimulation signal and the exhalation stimulation signal, the current intensity of the electrical stimulation module 231 still linearly varies within the range of 1 - 3 mA, but compared with the first stage, the speed of linear increase and decrease is further accelerated. This more rapid change can more efficiently guide the pregnant woman to perform the inhalation and exhalation actions. At the same time, the vibration frequency of the massage stimulation module 232 is increased to approximately 80 Hz, and the amplitude is maintained at 3.5 mm, making the vibration more obvious to attract the pregnant woman's attention and promote the deep breathing action.

[0067] For the pain-relieving stimulation signal, the current intensity of the electrical stimulation module 231 is increased to the upper limit set by the processing unit 220 (e.g., 6 mA), and the duration is extended to nearly 60 seconds to enhance the distraction effect; the frequency of the massage stimulation module 232 is increased to nearly the upper limit set by the processing unit 220 (e.g., 180 Hz), while maintaining the amplitude at 1 mm, thereby strengthening the relief effect and providing stronger analgesic support.

[0068] In response to the analgesic stimulation signal, the electrical stimulation module 231 starts with a lower intensity (e.g., 8 mA) and is gradually adjusted to a higher intensity (e.g., 10 - 12 mA) as needed to adapt to the changing intensity of uterine contractions. The massage stimulation module 232 then uses a higher amplitude (e.g., 4 mm) to provide stronger support, ensuring effective pain relief during strong uterine contractions while avoiding excessive stimulation.

[0069] Preferably, in the adjustment plan of the third stage, the processing unit 220 adjusts the stimulation parameters of the electrical stimulation module 231 and the massage stimulation module 232 to the same settings as in the first stage. This adjustment aims to reduce the additional stimulation to the pregnant woman and avoid potential risks, ensuring that the parameters of all stimulation signals return to the milder configuration of the first stage. In addition, the processing unit 220 instructs the communication unit 210 to send a drug-induced analgesia prompt to the external display unit 300 or the fetal heart monitor 100, so that medical staff can intervene in a timely manner and take necessary medical intervention measures. This dual safeguard mechanism not only ensures the effectiveness and safety of the analgesia strategy but also can respond quickly in case of abnormal fetal heart rate, giving priority to ensuring the health of the fetus.

[0070] Embodiment 2

[0071] This embodiment is a further supplement to the foregoing embodiments, and the repeated content will not be elaborated.

[0072] This embodiment will combine the contraction stress test (CST) Figures 5 to 8 to exemplarily illustrate the operation mechanism of the system of the present invention and the specific response solutions of the stimulation generator 200 under different contraction states.

[0073] In the pregnant woman contraction stimulation generator 200 of this embodiment, based on the monitoring of the pregnant woman's contraction state, using the mathematical model pre-stored in the processing unit 220, relevant electrical stimulation parameters (electrical stimulation intensity) or physical massage parameters (vibration frequency and vibration amplitude) for effective stimulation are given, thereby improving the comfort and safety of the pregnant woman.

[0074] As Figure 5 shown, the figure depicts the curve of the fetal heart rate over time (upper curve) and the curve of the intrauterine pressure over time (lower curve) during the CST. For the curve of the intrauterine pressure change, the abscissa in the figure represents time, and each small grid corresponds to 10 seconds; the ordinate represents the intrauterine pressure, and each small grid corresponds to 10 mmHg. Each paragraph of the intrauterine pressure increase lasting more than 20 seconds in the figure represents a contraction event. For example, Figure 5 four obvious contraction phenomena were observed. During the first contraction, the intrauterine pressure rapidly increased from about 30 mmHg to nearly 65 mmHg within a time span of about 10 seconds, indicating a significant contraction peak, and its rising slope was 3.5 mmHg / s. Immediately following this was a pressure drop period of about 30 seconds.

[0075] When the processing unit 220 detects that the rate of increase in uterine pressure within a certain period exceeds the preset starting slope, it is determined that uterine contractions have started, and a corresponding inspiratory stimulation signal is triggered and sent to the electrical stimulation module 231 or the massage stimulation module 232 of the stimulation unit 230 to simulate deep breathing movements to help the pregnant woman relieve the discomfort caused by uterine contractions.

[0076] Among them, if the stimulation unit 230 instructs the electrical stimulation module 231 to provide respiratory guidance support for the pregnant woman, the stimulation intensity I i (t) of its electrical stimulation module 231 during the inspiratory phase (this calculation formula can be used as a pre-stored mathematical model or a part of this mathematical model) is:

[0077]

[0078] In the formula, I min (unit: A) refers to the initial stimulation intensity, and I max (unit: A) refers to the maximum stimulation intensity. Both parameters can be set by the stimulation unit 230, and the set values can be determined by medical staff within the recommended electrical stimulation range for clinical pregnant women. R(P) refers to the response adjustment coefficient, which is calculated based on the uterine pressure P. The specific form is:

[0079] R(P) = k r ·H(P - T 1 )

[0080] k r (unit: A / mmHg) is a gain coefficient related to the change in uterine pressure, reflecting the sensitivity of the response of the stimulation intensity to the change in uterine pressure. This coefficient can be obtained by analyzing the historical data of pregnant women stored in the hospital's electronic health record system. These data include uterine pressure measurement values and their corresponding stimulation intensity responses, and are determined by relevant experts.

[0081] H is the step function, which is 1 when P > T 1 and 0 otherwise. T 1 (unit: mmHg) refers to the first threshold of uterine pressure, which can be determined based on clinical experience, for example. W(P'): The slope weight function represents the influence of the rate of change of uterine pressure. The specific form is:

[0082]

[0083] P' (unit: mmHg / s) refers to the rate of change of uterine pressure, which can be obtained through real-time monitoring. α (dimensionless) refers to the adjustment coefficient, which can be determined by clinical trials, for example. S s (unit: mmHg) is the reference value of the slope, which can be set based on clinical data, for example. T i(Unit: s) is the reference time related to inspiration, which can be dynamically adjusted according to the patient's response within the numerical range given in relevant medical guidelines. t (Unit: s) refers to the current time and changes as the stimulation progresses. t s (Unit: s) refers to the time when the stimulation starts.

[0084] If the stimulation unit 230 instructs the massage stimulation module 232 to provide breathing guidance support for a pregnant woman, the calculation formulas for the vibration frequency and vibration amplitude of the massage stimulation module 232 during the inspiration phase (these calculation formulas can be used as a pre-stored mathematical model or a part of this mathematical model) are as follows:

[0085] f i (t) = f i0 +k i ·R(P)

[0086]

[0087] In the formula, f i0 (Unit: Hz) is the initial vibration frequency of the inspiration stimulation; A i0 (Unit: mm) refers to the initial amplitude of the inspiration stimulation. Both of them can be determined by medical staff within the range recommended clinically. k i (Unit: Hz / A) is the frequency increment coefficient related to the uterine pressure, which can be determined by clinical trials and can be dynamically adjusted according to the patient's feedback.

[0088] See Figure 6 , this figure shows the occurrence of seven uterine contractions. Especially near the fourth uterine contraction peak, the rate of uterine pressure drop is about 3 mmHg / s. Once the processing unit 220 calculates that the rate of uterine pressure drop within a certain time period exceeds the set stop slope, it is considered that the uterine contraction ends, and an exhalation stimulation signal is generated and transmitted to the stimulation unit 230 to guide the pregnant woman to perform a relaxation-type exhalation action, so as to assist in reducing the physical tension after the uterine contraction.

[0089] Among them, if the stimulation unit 230 instructs the electrical stimulation module 231 to provide breathing guidance support for a pregnant woman, the calculation formula for the stimulation intensity I e (t) of the electrical stimulation module 231 during the exhalation phase (this calculation formula can be used as a pre-stored mathematical model or a part of this mathematical model) is as follows:

[0090]

[0091] The parameters in the formula have the same meaning as the parameters in the calculation formula for the stimulation intensity I i (t) during the previous inspiration phase, where T eIt is a time parameter related to exhalation and can also be dynamically adjusted according to the patient's response within the numerical range given in the relevant medical guidelines.

[0092] If the stimulation unit 230 instructs the massage stimulation module 232 to provide breathing guidance support for a pregnant woman, the calculation formulas for the vibration frequency and amplitude during the exhalation phase (which can be used as a pre-stored mathematical model or a part of the mathematical model) are as follows:

[0093] f e (t) = f e0 -k e ·R(P)

[0094]

[0095] In the formula, f e0 (unit: Hz) refers to the initial vibration frequency of exhalation stimulation, and A e0 (unit: mm) refers to the initial amplitude of exhalation stimulation. Both can be determined by medical staff within the range recommended clinically. k e (unit: Hz / A) is the frequency decrement coefficient related to uterine pressure, determined by clinical trials and can be dynamically adjusted according to the patient's feedback.

[0096] As Figure 7 shown, seven uterine contraction processes were also recorded. The third uterine contraction is characterized by a uterine pressure rising rate of 4 mmHg / s and reaching a peak value close to 100 mmHg. When the processing unit 220 determines that the uterine pressure rising rate within a certain period exceeds the starting slope and the peak uterine pressure exceeds a predefined first threshold, a pain relief stimulation signal will be generated and transmitted to the stimulation unit 230 through the internal communication bus, instructing it to perform mechanical massage or electrical stimulation different from the conventional inhalation and exhalation guidance, aiming to distract attention and relieve pain.

[0097] Specifically, if the stimulation unit 230 instructs the electrical stimulation module 231 to provide pain management for a pregnant woman, the calculation formula for the electrical stimulation intensity I r (t) (which can be used as a pre-stored mathematical model or a part of the mathematical model) is as follows:

[0098]

[0099] In the formula, I b (unit: A) refers to the reference intensity of pain relief stimulation, and I h (unit: A) refers to the maximum intensity of pain relief stimulation. Both are determined by medical staff according to the clinically recommended values.

[0100] C(P) is the comfort correction coefficient, calculated based on the uterine pressure P, and its specific form is:

[0101]

[0102] Among them, T 1 (unit: mmHg) refers to the first threshold of uterine pressure, which is determined based on clinical experience. T h (unit: mmHg) refers to the highest threshold of uterine pressure, which determines the safety upper limit of uterine pressure and avoids discomfort or complications that may be caused by exceeding this threshold. It is set based on clinical historical data.

[0103] D r (unit: s) refers to the duration of the pain-relieving stimulation, which is actually measured according to the patient's response.

[0104] C d (D r , t - t s ) is a time-based adjustment function, which represents the change of stimulation intensity over time. The specific form is as follows:

[0105]

[0106] In the formula, D r (unit: s) refers to the duration of the pain-relieving stimulation, which can be set as the maximum duration of the stimulation effect. t - t s (unit: s) refers to the time since the start of the stimulation, which is used to provide a time reference for dynamic changes.

[0107] When t - t s < 0, it means that the stimulation has not started yet, and the function value is 0, indicating that there should be no pain-relieving stimulation effect at this time; when 0 ≤ t - t s < D r , the function value increases linearly from 0 to 1, indicating that the stimulation effect gradually increases until the set maximum duration D r ; when t - t s ≥ D r , the function value is 1, indicating that the pain-relieving stimulation has reached its maximum effect and can continue until the end.

[0108] If the stimulation unit 230 instructs the massage stimulation module 232 to provide pain management for the pregnant woman, the calculation formulas for the vibration frequency and vibration amplitude of the pain-relieving stimulation (this calculation formula can be used as a pre-stored mathematical model or a part of this mathematical model) are as follows:

[0109] f r (t) = f r0 + k r ·R(P)

[0110]

[0111] where f r0 (unit: Hz) refers to the initial vibration frequency of the pain relief stimulation, and A r0 (unit: mm) refers to the initial amplitude of the pain relief stimulation. Both can be determined by medical staff within the range recommended clinically. k r (unit: Hz / A) refers to the frequency increment coefficient related to uterine pressure, which needs to be set through clinical trials and adjusted dynamically according to patient feedback.

[0112] Figure 8 shows a complete uterine contraction cycle from start to end. During this process, the rising rate of uterine pressure is 4.5 mmHg / s, and the peak value exceeds 100 mmHg. If the processing unit 220 detects that the rising rate of uterine pressure within a certain period exceeds the starting slope and the peak uterine pressure exceeds a more stringent second threshold, it is determined as a severe uterine contraction event. At this time, the processing unit 220 will send out an analgesic stimulation signal, which is transmitted to the stimulation unit 230 via the internal communication bus, prompting it to perform high-intensity electrical stimulation or mechanical massage operations to provide additional analgesic support to ensure that the pregnant woman can get effective relief.

[0113] Specifically, if the stimulation unit 230 instructs the electrical stimulation module 231 to provide pain management for the pregnant woman, the calculation formula for the electrical stimulation intensity I a (t) of the analgesic stimulation (this calculation formula can be used as a pre-stored mathematical model or a part of this mathematical model) is as follows:

[0114]

[0115] where I l (unit: A): the reference intensity of the analgesic stimulation, I p (unit: A): the maximum intensity of the analgesic stimulation. Both are determined by medical staff according to the clinically recommended values. D a (unit: s): the duration of the analgesic stimulation, which is actually measured according to the patient's reaction.

[0116] If the stimulation unit 230 instructs the massage stimulation module 232 to provide pain management for the pregnant woman, the calculation formulas for the vibration frequency and vibration amplitude of the analgesic stimulation (this calculation formula can be used as a pre-stored mathematical model or a part of this mathematical model) are as follows:

[0117] f a (t) = f a0 + k a ·R(P)

[0118]

[0119] where f a0 (unit: Hz) refers to the initial vibration frequency of the analgesic stimulation, Aa0 (Unit:mm) refers to the initial amplitude of the analgesic stimulation, and both can be determined by medical staff within the clinically recommended range. k a (Unit: Hz / A) refers to the frequency increment coefficient related to the uterine pressure, which needs to be set through clinical trials and dynamically adjusted according to the patient's feedback.

[0120] It should be noted that the above specific embodiments are exemplary. Those skilled in the art can come up with various solutions inspired by the disclosure of the present invention, and these solutions also fall within the disclosure scope and protection scope of the present invention. Those skilled in the art should understand that the specification and drawings of the present invention are illustrative and do not constitute a limitation to the claims. The protection scope of the present invention is defined by the claims and their equivalents. The specification of the present invention contains multiple inventive concepts. For example, "preferably" or "according to a preferred embodiment" indicates that the corresponding paragraph discloses an independent concept. The applicant reserves the right to file divisional applications according to each inventive concept. Throughout the text, the features guided by "preferably" are only optional ways and should not be understood as must-be-set. Therefore, the applicant reserves the right to abandon or delete relevant preferred features at any time.

Claims

1. A system for assisting a pregnant woman in natural childbirth, characterized in that: include: A fetal heart monitor (100) is used to monitor changes in uterine cavity pressure during childbirth by means of a pressure probe (110) placed on the abdominal wall of a pregnant woman; A stimulation generator (200) which provides a stimulation signal corresponding to the change in uterine cavity pressure provided by the fetal heart monitor (100); The stimulation generator (200) has a communication unit (210), and the communication unit (210) is used to obtain a uterine cavity pressure change signal related to the corresponding pregnant woman from the fetal heart monitor (100), and provide the uterine cavity pressure change signal to the processing unit (220) of the stimulation generator (200). The processing unit (220) of the stimulation generator (200) determines the timing, intensity and duration of the stimulation signal by analyzing changes in uterine cavity pressure.

2. The system according to claim 1, characterized in that The stimulation generator (200) comprises a stimulation unit (230) which is communicatively connected to the processing unit (220), and the stimulation unit (230) performs specific stimulation actions according to instructions issued by the processing unit (220) to assist pregnant women in managing pain and breathing rhythm during childbirth, wherein: The stimulation unit (230) can apply current stimulation with different pulse intensities by means of an electrical stimulation module (231), and / or can apply physical vibration stimulation with different frequencies and amplitudes by means of a massage stimulation module (232).

3. The system according to claim 1 or 2, characterized in that: The processing unit (220) of the stimulation generator (200) determines the slope and duration of the change in uterine pressure at each time point by determining the characteristics of the change in uterine pressure over time. When it is detected that the uterine pressure change meets the preset conditions, the processing unit (220) generates one of the matching inhalation stimulation signal, exhalation stimulation signal, pain relief stimulation signal or analgesia stimulation signal to instruct the stimulation unit (230) to set the stimulation parameters of the electrical stimulation module (231) and / or the massage stimulation module (232).

4. The system according to any one of claims 1 to 3, characterized in that: When the processing unit (220) detects that the rising slope of uterine pressure reaches its preset starting slope, the processing unit (220) generates a signal for generating the inhalation stimulation signal and sends it to the stimulation unit (230) to guide the inhalation action.

5. The system according to any one of claims 1 to 4, characterized in that: When the processing unit (220) detects that the uterine pressure drop slope reaches its preset stop slope, the processing unit (220) generates a signal for generating the exhalation stimulation signal and sends it to the stimulation unit (230) to guide the exhalation action.

6. The system according to any one of claims 1 to 5, characterized in that: When the processing unit (220) detects that the rising slope of uterine pressure exceeds the starting slope and the uterine pressure is greater than a preset first threshold, the processing unit (220) can identify it as a uterine contraction start signal requiring pain relief support, generate a signal for generating the pain relief stimulation signal, and send it to the stimulation unit (230) to relieve uterine contraction pain.

7. The system according to any one of claims 1 to 6, characterized in that: When the processing unit (220) detects that the uterine pressure is greater than a preset second threshold, the processing unit (220) identifies that this is a signal of severe uterine contraction, generates a signal for generating the analgesic stimulation signal, and sends it to the stimulation unit (230) to relieve the uterine contraction pain, wherein: If the uterine pressure is greater than the second threshold value for a period of time exceeding a predetermined time, the processing unit (220) generates a prompt instruction for prompting drug analgesia, and sends it to the external display unit (300) through the communication unit (210).

8. The system according to any one of claims 1 to 7, characterized in that: Inspiratory stimulation is applied to pregnant women by gradually increasing the amplitude and / or intensity of stimulation to simulate the feeling of deep inspiration; Exhalation stimulation is applied to pregnant women through gradually decreasing stimulation amplitude and / or intensity to guide them to perform soothing exhalation movements; Analgesic stimulation uses a stronger stimulation amplitude or intensity than inhalation stimulation and exhalation stimulation to distract attention and reduce pain perception; Analgesic stimulation further increases the stimulation amplitude or intensity based on pain-relieving stimulation.

9. The system according to any one of claims 1 to 8, characterized in that: When generating an exhalation stimulation signal, an inhalation stimulation signal, analgesia stimulation signal and analgesia stimulation signal, the processing unit (220) can obtain fetal heart rate changes from the fetal heart monitor (100) and use them to generate or stop corresponding stimulation and / or generate corresponding prompt information to the external display unit (300).

10. The system according to any one of claims 1 to 9, characterized in that: The processing unit (220) can introduce a phased adjustment plan for the stimulation unit (230) according to the change of the fetal heart rate. According to the specific change of the fetal heart rate, the processing unit (220) instructs the electrical stimulation module (231) and / or the massage stimulation module (232) in the stimulation unit (230) to adjust the corresponding stimulation parameters, so that the stimulation generator (200) operates according to the adjustment plan at different stages.

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