Obstetrical high-frequency electrotome system and safety control method thereof

Abstract

The invention discloses an obstetrical high-frequency electrotome system and a safety control method thereof, which are applied to obstetrical operation cutting and blood coagulation, and relates to the technical field of obstetrical operation instrument safety control, the obstetrical high-frequency electrotome system comprises a preoperative module for acquiring data such as tissue thickness, blood vessel density and the like through ultrasound, and combining with a gestational week preset power and a polar plate pressure threshold; the intra-operation module is used for synchronously acquiring parameters such as current and temperature, monitoring pole plate impedance and contact force and performing threshold exceeding early warning; the dynamic adjusting module is used for automatically adjusting power according to temperature, blood vessel density and the like, switching modes and giving an alarm or stopping in case of abnormity; the fetal heart linkage module is used for collecting fetal heart in real time and adjusting power or stopping when the heart rate fluctuates; and the emergency recording module is provided with a double shutdown mechanism, automatically stores data and generates a report after operation. Through full-process safety control, the safety, accuracy and traceability of an obstetric electrotome operation are improved, the safety of a puerpera and a fetus is guaranteed in multiple dimensions, and intelligent development of instruments is promoted.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of obstetric surgical instrument safety control, and particularly relates to an obstetric high-frequency electrotome system and a safety control method thereof. BACKGROUND

[0002] As the core instrument in obstetric surgery (such as cesarean section and myomectomy), the performance and control accuracy of the high-frequency electrotome directly affect the safety of the surgery. The parameter setting of the traditional high-frequency electrotome depends on the experience of the physician, and only a fixed power (such as cutting power 50W and coagulation power 40W) is preset according to the type of surgery before the surgery, without considering the individual differences of the pregnant woman - the thickness of the myometrium and the density of blood vessels of the pregnant woman at different gestational weeks are significantly different. The myometrium of the pregnant woman with gestational weeks ≤37 weeks is relatively thin (about 2-3mm), and if the high-power parameter of the full-term pregnant woman is used, it is easy to cause excessive thermal damage to the myometrium, increasing the risk of poor postoperative uterine scar healing. While the pregnant woman with gestational weeks >37 weeks has a higher density of uterine blood vessels, and fixed low power may result in incomplete coagulation, causing intraoperative bleeding. At the same time, the traditional electrotome lacks dynamic assessment of the contact quality of the electrode plate, and only determines whether it is in contact through a simple pressure sensor. When the pregnant woman is obese or has skin wrinkles, the actual contact area of the electrode plate is insufficient, which may cause skin burns due to high current density. The incidence of such complications in obstetric surgery can reach 3%-5%.

[0003] The single monitoring dimension in the surgery is also a major defect of the traditional high-frequency electrotome. The traditional system only monitors the output power and current, and cannot capture the temperature change of the tissue in real time. When the temperature at the action point of the high-frequency electrotome exceeds 65℃, it will cause protein denaturation of the myometrium, affecting the postoperative uterine contraction function. However, the traditional system has no temperature warning mechanism, and the physician needs to observe the color of the tissue by naked eye to judge the degree of thermal damage, which is highly subjective and lagging. In addition, fetal safety is a key concern in obstetric surgery, and the traditional electrotome and fetal heart monitor work independently. The high-frequency electromagnetic interference generated by the electrotome when working will cause distortion of the fetal heart signal, making it difficult for the physician to accurately judge the change of the fetal heart rate. If the power of the electrotome is too high and causes abnormal uterine contraction, it may lead to fetal distress in utero. However, the traditional system cannot realize the linkage adjustment of the electrotome parameters and the vital signs of the fetus, missing the best intervention opportunity. At the same time, the smoke generated during the surgery will block the vision, and the traditional electrotome has no smoke concentration monitoring and automatic smoke exhaust function. The physician needs to manually adjust the smoke exhaust device, increasing the complexity of the surgical operation and prolonging the operation time.

[0004] The lack of emergency handling and data traceability also restricts the safety of traditional high-frequency electrotomes. The emergency shutdown of traditional systems only relies on foot switches. If the foot switch fails or the doctor makes a mistake, the output cannot be quickly cut off, which may cause excessive tissue damage. After a fault occurs, the system has no self-diagnosis function, and the doctor needs to check the power supply, cable, and knife head one by one. The average fault handling time is more than 10 minutes, which seriously affects the operation process. In addition, the traditional system only records the operation time and total power, lacks key data such as knife head position, real-time parameter adjustment, and early warning events, and cannot replay the operation process after the operation. If complications such as uterine perforation and postoperative bleeding occur, it is difficult to trace the cause, and it is also difficult to provide standardized operation training basis for novice doctors. These problems together lead to the prominent safety hazards of traditional high-frequency electrotomes in obstetric surgery, and an urgent need for a safety control method with personalized parameter presetting, multi-dimensional real-time monitoring, fetal linkage protection, rapid emergency handling, and complete data traceability. SUMMARY

[0005] The obstetric high-frequency electrotome system and its safety control method proposed by the present application solve the problems mentioned in the prior art.

[0006] In order to achieve the above purpose, the present application adopts the following technical scheme: an obstetric high-frequency electrotome system and its safety control method, comprising the following steps: Preoperative tissue characteristic detection and parameter presetting, the ultrasonic Doppler probe is used to scan the operation area to obtain the uterine muscle layer, placenta attachment and adjacent blood vessel distribution data; based on the detection data, the system automatically matches the preset parameter library, and presets the cutting power and coagulation power initial value for the lower uterine segment cesarean section operation, and adjusts the electrode plate contact pressure threshold value according to the gestational age; Real-time multi-parameter monitoring during operation, an integrated sensor module is used to synchronously collect electrotome working parameters and tissue reaction data; an infrared temperature measuring instrument is used to monitor the temperature of the knife head action point in real time; at the same time, the contact impedance of the electrode plate is monitored, and when the impedance value exceeds the baseline value by a certain range, a preliminary warning is triggered; in addition, a pressure sensor is used to monitor the contact force between the knife head and the tissue in real time; Dynamic power adjustment and safety intervention, the system starts the closed-loop adjustment mechanism according to the real-time monitoring data, and automatically reduces the output power when the tissue temperature exceeds the limit; when a high blood vessel density area is detected, the system automatically switches to the coagulation mode and limits the power; a safety distance monitoring is set for the operation near the uterine artery, and when the knife head enters the safety distance range, the power is forced to reduce and a vibration prompt is started; Fetal vital sign linkage monitoring, fetal heart rate data are collected in real time by a fetal heart monitor, and when the electrotome is started, the fetal heart monitoring data are synchronously transmitted to the high-frequency electrotome system. When the fetal heart rate abnormally fluctuates and lasts for a certain period of time, the system automatically reduces the power and highlights the abnormal mark. If the heart rate fluctuation continues without relief, the system will be forced to shut down, and it can be restarted after the heart rate recovers and the doctor confirms it; Emergency treatment and operation record, set double emergency shutdown mechanism, shutdown after automatic record shutdown time all parameters; data storage format is encrypted CSV file; postoperative automatic operation report, for postoperative evaluation and traceability. In the application, the tissue thermal injury risk assessment unit is also included, the multi-point sampling function of the infrared thermometer is used to ensure that the temperature data is representative, the contact time is distinguished between continuous contact and intermittent contact; the output current is calculated by using the effective current, and the interference of the peak current on the evaluation result is excluded; the unit optimizes the power adjustment by calculating the thermal injury index, and the calculation method of the thermal injury index is Wherein H is the thermal injury index; k1 is the temperature coefficient; T is the tissue temperature; t is the contact time of the tool head and the tissue; k2 is the current coefficient; I is the output effective current; d is the tissue depth; the system divides H into three risk levels.

[0007] In the application, the electrode plate contact quality dynamic evaluation module is also included, the module uses a capacitive sensor to scan the contact area of the electrode plate and the skin of the parturient woman; the standard contact area S is adjusted according to the type of the electrode plate, and is suitable for different specifications of the neutral electrode; the rated pressure P is subdivided according to the gestational age; the module judges the contact quality by calculating the contact safety coefficient, and the calculation method of the contact safety coefficient is S=S real / S standard x (1-P deviation / P equivalent), wherein S is the contact safety coefficient; S real is the actual contact area; S standard is the standard contact area; P deviation is the deviation value of the actual pressure and the rated pressure; P equivalent is the rated pressure; when S<0.6, the system determines that the contact is poor, in addition to issuing 80-90dB sound and light alarm, the thermal map of the poor contact area is also displayed on the display screen, guiding the medical staff to adjust the electrode plate position or increase the contact pressure.

[0008] In the application, the preoperative tissue characteristic detection also includes elastic modulus measurement, the shear wave elastography technology is used, and the areas commonly used in obstetric surgery, such as lower uterine segment, cervix and placenta attachment, can be covered; the system establishes a corresponding database of elastic modulus and tissue type, automatically matches the tool head feeding speed according to the detected tissue type, and the feeding speed of dense tissue with an elastic modulus greater than 50kPa is limited to less than 5mm / s; the feeding speed of loose tissue with an elastic modulus less than 20kPa is set to 10-15mm / s; the feeding speed of medium texture tissue with an elastic modulus of 20-50kPa is set to 8-12mm / s; at the same time, the feeding speed adjustment is linked with the tool head contact force monitoring, when the contact force exceeds 2N, regardless of the elastic modulus, the tissue is prevented from being damaged due to excessive force during the operation of the medical staff, and it is especially suitable for key steps such as uterine incision and placenta detachment in cesarean section surgery.

[0009] In the application, the intraoperative real-time multi-parameter monitoring further includes smoke concentration detection, and a laser scattering smoke detector is used; a universal adjustable smoke exhaust pipe is provided as the system matched smoke exhaust device, and a HEPA high efficiency filter screen is arranged on the pipe; when the smoke concentration is detected to be greater than 100 mg / m3, the system automatically starts the smoke exhaust device, and it is suggested that the operation is paused for 10 seconds, and the operation failure caused by smoke shielding the operation field is especially suitable for long time obstetric surgery.

[0010] In the application, the dynamic power regulation further includes a multi-mode switching mechanism, three special modes of fine cutting, rapid coagulation and blood vessel sealing are set, and one-key switching is realized through a foot switch; the fine cutting mode is suitable for steps such as uterine muscle incision which need accurate operation, a straight-shaped cutter head is used, and the output waveform is a continuous sine wave; the rapid coagulation mode is suitable for small area bleeding during operation, pulse type output is used, and the pulse width is dynamically adjusted according to the bleeding condition; the diameter of the blood vessel is measured in real time through intraoperative ultrasound, the cutter head is required to be attached to the blood vessel wall during operation, the contact force is controlled to be 1-1.5 N, and the blood flow signal of the blood vessel is automatically detected after sealing.

[0011] In the application, the fetal vital sign linkage monitoring further includes electromagnetic interference shielding measures; a manganese-zinc ferrite magnetic ring is sleeved on the signal line of the fetal heart monitor; the system detects the signal-to-noise ratio of the fetal heart signal once every 50 ms, simultaneously prompts "electromagnetic interference is enhanced, please adjust the position of the electrotome" on the display screen, and marks the relative distance between the current electrotome and the fetal heart probe; in addition, the fetal heart monitoring data is transmitted in differential signal mode.

[0012] In the application, the safety control method of the obstetric high-frequency electrotome system includes the following steps: a preoperative tissue characteristic detection and parameter presetting step: the operation area is scanned by an ultrasonic Doppler probe to obtain the distribution data of the uterine muscle layer, the placenta attachment and the adjacent blood vessels; based on the detection data, the system automatically matches a preset parameter library; An intraoperative real-time multi-parameter monitoring step: integrated sensor modules are used to synchronously collect electrotome working parameters and tissue reaction data; an infrared temperature detector is used to monitor the temperature of the cutter head action point in real time; and the contact impedance of the electrode plate is monitored at the same time; A dynamic power regulation and safety intervention step: the system starts a closed loop regulation mechanism according to the real-time monitoring data, automatically reduces the output power when the tissue temperature exceeds 60 DEG C, and automatically switches to the coagulation mode when the blood vessel density of a region is detected to be greater than 5 / mm2; A fetal vital sign linkage monitoring step: fetal heart rate data are collected in real time by a fetal heart monitor, and the fetal heart monitoring data are synchronously transmitted to the high-frequency electrotome system when the electrotome is started; An emergency treatment and operation record step: a double emergency shutdown mechanism is set, including a foot switch emergency brake and a hand-held cutter head button brake, and all parameters at the shutdown time are automatically recorded by the system after shutdown; the data storage format is an encrypted CSV file.

[0013] In the application, the operation record further comprises three-dimensional operation trajectory reconstruction, and a six-axis gyroscope and a three-axis acceleration sensor are built in the tool head; a three-dimensional coordinate system is established with the midpoint of the operating table edge as the origin, and the angular velocity and acceleration data are converted into three-dimensional coordinates of the tool head through integral operation; after the operation, the tool head trajectory is superimposed on the anatomical structure of the uterus, placenta and blood vessels combined with the preoperative ultrasonic tomographic image, a three-dimensional operation path diagram is generated, the power adjustment point is marked with red, the warning position is marked with yellow flickering, and the power, temperature and contact force data of each position are labeled.

[0014] In the application, a physician operation proficiency evaluation unit is further included; the unit evaluates the physician proficiency by calculating an operation stability index, and the operation stability index is calculated in the following manner , wherein W is the operation stability index, which is dimensionless, v_i is the tool head moving speed of the i-th sampling, and v_avg is the average moving speed; the system divides W into three levels, W≤0.2 is stable operation, 0.2

[0015] Compared with the prior art, the application has the following beneficial effects: In the preoperative parameter setting link, individual data such as tissue thickness and blood vessel density are obtained through an ultrasonic Doppler probe, and the power and polar plate pressure thresholds are dynamically adjusted according to the gestational age, thereby avoiding the problems of thermal damage or insufficient coagulation caused by traditional fixed parameters, greatly improving the accuracy of parameter setting, adapting to the operation needs of different gestational ages and different tissue textures, and reducing the operation risks caused by improper preoperative parameters.

[0016] In the intraoperative monitoring and adjustment aspect, multi-parameter synchronous acquisition (power, temperature, contact force, polar plate impedance, etc.) is realized to comprehensively control the operation process, the power is automatically reduced when the temperature exceeds the limit, and the coagulation mode is switched in the blood vessel dense area, thereby avoiding local heat accumulation and excessive cutting, and significantly improving the safety of intraoperative operation; smoke concentration monitoring and automatic smoke exhaust function ensure clear operation field of view, reduce manual operation interference, and improve operation efficiency; electromagnetic interference shielding measures and fetal heart linkage adjustment ensure accurate fetal heart rate monitoring, and the electrotome parameters are dynamically adjusted according to the fetal heart fluctuation, thereby avoiding fetal distress in utero and providing double protection for fetal safety.

[0017] The emergency treatment and data tracing capability are greatly enhanced, the double emergency shutdown mechanism (foot pedal + knife head button) ensures quick cut-off of the output, the fault self-diagnosis function can accurately locate the problem and provide troubleshooting suggestions, shorten the fault handling time, and reduce the risk of operation interruption; complete operation record (real-time parameters, knife head trajectory, early warning events) and three-dimensional trajectory reconstruction, realize the whole process tracing of the operation, and the operation details can be reviewed after the operation, provide basis for complication analysis, and provide visual training materials for novice doctors, help to improve the standardization of operation skills.

[0018] In addition, the physician operation proficiency evaluation unit helps novice doctors to improve operation stability under the premise of ensuring safety by dynamically adjusting safety redundancy, and gradually reduces the dependence on experience; organ heat damage risk assessment and electrode plate contact quality assessment are carried out, further refining the safety control dimension, avoiding deep tissue damage and skin burns. Overall, the present application significantly improves the safety, accuracy and traceability of obstetric high-frequency electrotome operation through the design of whole-process and multi-dimensional safety control, ensures the safety of puerpera and fetus, and promotes the development of obstetric surgical instruments towards intelligence and individualization. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 A schematic block diagram of an obstetric high-frequency electrotome system is provided for the present application; Figure 2 A schematic block diagram of an obstetric high-frequency electrotome safety control method is provided for the present application; Figure 3 A comparison chart of preoperative cutting power adaptation for different gestational weeks; Figure 4 A graph of intraoperative tissue temperature change trend; Figure 5 A graph of intraoperative electrode plate contact safety factor change; Figure 6 A graph of novice physician operation stability index change. DETAILED DESCRIPTION

[0020] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of protection of the present application.

[0021] In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, which are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0022] In addition, the terms "first", "second" are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the technical features referred to. Therefore, the features defined with "first", "second" can explicitly or implicitly include one or more of the features. In the description of the present application, the meaning of "multiple" is two or more, unless otherwise specifically limited. In addition, the terms "mounting", "connecting", "connecting" should be broadly understood, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium, or it can be the communication between two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances, and the present application will be further described in detail below with reference to the drawings.

[0023] Reference Figures 1 to 5 : A high-frequency electrotome system for obstetrics is applied to tissue cutting and coagulation operation in obstetric surgery, comprising: A preoperative tissue characteristic detection and parameter presetting module, the module is configured to scan the operation area by an ultrasonic Doppler probe, obtain the distribution data of the uterine muscle layer, the placenta attachment and the adjacent blood vessels, determine the tissue thickness, the blood vessel density and the impedance baseline value, wherein the tissue thickness measurement accuracy is controlled within ±0.1mm, the blood vessel density is counted by the number of blood vessel cross sections per square millimeter, the impedance baseline value is obtained by averaging 3 repeated measurements, and the range is set to 500-2000Ω; and based on the detection data, automatically match the preset parameter library, preset the cutting power initial value for lower uterine segment cesarean section surgery as 30-50W, and the coagulation power initial value as 20-40W, and simultaneously adjust the electrode plate contact pressure threshold value according to the gestational age, the threshold value is set to 0.3-0.5N when the gestational age is ≤37 weeks, and the threshold value is set to 0.5-0.7N when the gestational age is >37 weeks, so as to realize good contact of the electrode plate with the skin of the parturient woman and avoid excessive compression; Intraoperative real-time multi-parameter monitoring module, the module is configured to use an integrated sensor module to synchronously collect electrosurgical unit operating parameters and tissue reaction data, wherein the current monitoring accuracy is ±1 mA, the voltage monitoring accuracy is ±1 V, and the frequency is stabilized at 300-500 kHz; the temperature at the action point of the blade is monitored in real time by an infrared thermometer, the sampling frequency is 100 Hz, the temperature measurement range is 30-150℃, and the accuracy is ±0.5℃; the contact impedance of the electrode plate is monitored at the same time, and the data is updated once every 50 ms, and a preliminary warning is triggered when the impedance value exceeds the baseline value by ±20%; in addition, the contact force between the blade and the tissue is monitored in real time by a pressure sensor, the range is 0-5 N, the accuracy is ±0.1 N, and excessive damage to the tissue caused by excessive contact force is avoided; Dynamic power regulation and safety intervention module, the module is configured to start a closed-loop regulation mechanism according to real-time monitoring data, when the tissue temperature exceeds 60℃, the output power is automatically reduced by 2-5 W for each 1℃ increase, until the temperature stabilizes at 50-55℃; when an area with a blood vessel density of >5 / mm2 is detected, the power is automatically limited to 20-30 W while switching to a coagulation mode; if the electrode plate contact impedance exceeds the normal range for more than 3 seconds, an audible and visual alarm is first issued, the alarm sound pressure level is 80-90 dB, the alarm light flashing frequency is 2 Hz, and if the fault is not eliminated within 5 seconds, the output is automatically cut off; for operations near uterine arteries, a 5 mm safety distance monitoring is set, when the blade enters the safety distance range, the power is forced to reduce to 50% of the initial value, and a vibration prompt is started, with a vibration frequency of 50 Hz; Fetal vital sign linkage monitoring module, the module is configured to collect fetal heart rate data in real time through a fetal heart monitor, with a sampling frequency of 1 Hz, and a normal range set at 110-160 beats / min, when the electrosurgical unit is started, the fetal heart monitoring data is synchronously transmitted to the high-frequency electrosurgical unit system, if the fetal heart rate fluctuates by >20 beats / min and lasts for more than 10 seconds, the power is automatically reduced to 30% of the initial value, and a fetal heart abnormality marker is highlighted on the display screen; if the heart rate fluctuation lasts for 30 seconds without relief, the machine is forced to stop until the heart rate returns to the normal range and the physician confirms that it can be restarted; Emergency handling and operation recording module, the module is configured to set a double emergency stop mechanism, including a footswitch emergency brake and a handheld blade button brake, with a response time of ≤0.1 second, and automatically records all parameters at the time of stopping after stopping; during the operation, operation data is automatically saved once every 10 seconds, including power, temperature, time, blade position coordinates, etc., the data storage format is an encrypted CSV file, and the storage period is not less than 5 years; an operation report is automatically generated after the operation, including parameter adjustment curves, warning event records, and fetal heart rate correlation analysis, for postoperative evaluation and traceability.

[0024] Further, it also includes a tissue thermal injury risk assessment unit, which is configured to collect the tissue temperature at 1mm around the action point of the knife head in real time during the operation, ensure the representativeness of the temperature data through the multi-point sampling function of the infrared temperature measuring instrument, distinguish between continuous contact and intermittent contact through contact time, accumulate the total contact time within a single operation during intermittent contact, and avoid thermal accumulation damage caused by short-time high-power operation; the output current uses effective current calculation to exclude the interference of peak current on the evaluation results, and the tissue depth is determined by preoperative ultrasound and updated synchronously every 20ms, which matches the actual surgical site; The unit optimizes power adjustment by calculating a thermal injury index, and the calculation method of the thermal injury index is Wherein H is the thermal injury index, dimensionless; k1 is the temperature coefficient, taking a value of 0.002; T is the tissue temperature, unit ℃; t is the contact time of the knife head with the tissue, unit second; k2 is the current coefficient, taking a value of 0.05; I is the output effective current, unit A; d is the tissue depth, unit mm; The system divides H into three levels of risk, H≤30 is low risk, maintaining the current power; 30<H≤50 is medium risk, automatically reducing the power by 15%; H>50 is high risk, immediately reducing the power by 30% and extending the monitoring interval to 10ms, while displaying the thermal injury risk level and the current main influencing factors on the display screen, avoiding deep tissue problems such as uterine muscle necrosis and blood vessel damage caused by local thermal accumulation through comprehensive multi-factor evaluation.

[0025] Further, it also includes a dynamic evaluation module of the contact quality of the electrode plate, which is configured to use a capacitive sensor to scan the contact area of the electrode plate with the skin of the parturient woman, with a scanning resolution of 0.1cm², and generate a contact area distribution map every 10ms to accurately obtain the actual contact area Sreal, avoiding the limitations of single-point measurement of traditional pressure sensors; the standard contact area Sstandard is adjusted according to the type of the electrode plate, and is set to 10cm² for a circular electrode plate and 12cm² for a rectangular electrode plate, which adapts to different specifications of neutral electrodes; the rated pressure P is subdivided according to gestational weeks, and is set to 0.4N for 32-37 weeks, 0.6N for 37-40 weeks, and 0.7N for more than 40 weeks, and the pressure deviation Pdev is calculated by taking the average value of the 6 pressure sensors uniformly distributed on the electrode plate, so as to realize the comprehensiveness of pressure evaluation; The module judges the contact quality by calculating the contact safety coefficient, and the calculation method of the contact safety coefficient is S=Sreal / Sstandard*(1-Pdev / Pex), wherein S is the contact safety coefficient, dimensionless; Sreal is the actual contact area, unit: cm2; Sstandard is the standard contact area, which is set according to the type of the electrode plate; Pdev is the deviation value of the actual pressure and the rated pressure, unit: N; Pex is the rated pressure, unit: N; when S<0.6, the system determines that the contact is poor, in addition to issuing 80-90dB sound and light alarm, the output power is automatically limited to not more than 20W, and at the same time, the thermal map of the poor contact area is displayed on the display screen, and the uncontacted area is marked with red, guiding the medical staff to adjust the electrode plate position or increase the contact pressure, so as to avoid the maternal skin burn caused by the high current density when the electrode plate is in poor contact, especially suitable for obese or more wrinkled maternal skin.

[0026] Further, the preoperative tissue characteristic detection and parameter preset module is further configured to measure the elastic modulus, adopts the shear wave elastography technology, the frequency of the ultrasonic probe is set to 5-10MHz, the sampling depth is 0-5cm, and the common lower uterine segment, cervix, placenta attachment and other areas in obstetric surgery can be covered. When measuring, a constant pressure of 5N is applied through the probe to avoid the influence of pressure change on the elastic modulus value. The measurement range is 1-100kPa, and the accuracy is ±1kPa; The system establishes a corresponding database of elastic modulus and tissue type, the elastic modulus of the uterine muscle layer corresponds to 25-40kPa, the placental tissue corresponds to 15-25kPa, and the blood vessel wall corresponds to 50-60kPa. According to the detected tissue type, the feed speed of the tool bit is automatically matched. The feed speed of the dense tissue (such as the blood vessel wall) with an elastic modulus greater than 50kPa is limited to within 5mm / s to avoid tearing of the tissue due to excessive cutting resistance. The feed speed of the loose tissue (such as the connective tissue around the placenta) with an elastic modulus less than 20kPa is set to 10-15mm / s to improve the efficiency of the operation. The feed speed of the medium-textured tissue (such as the uterine muscle layer) with an elastic modulus of 20-50kPa is set to 8-12mm / s. At the same time, the feed speed adjustment links the tool bit contact force monitoring. When the contact force exceeds 2N, regardless of the elastic modulus, the feed speed is reduced to 5mm / s to prevent the medical staff from damaging the tissue due to excessive force during operation, especially suitable for key steps such as uterine muscle incision and placenta detachment in cesarean section surgery.

[0027] Further, the intraoperative real-time multi-parameter monitoring module is further configured to detect smoke concentration, adopts a laser scattering type smoke detector, the laser wavelength is 650nm, the detection distance is 0-30cm, the detector position can be flexibly adjusted to cover the surgical incision area, the concentration measurement range is 0-500mg / m3, the accuracy is ±5mg / m3, the sampling frequency is 5Hz, and the smoke concentration change is captured in time. The system is equipped with a universal adjustable smoke exhaust pipe with a diameter of 50 mm, and the suction inlet wind speed can be adjusted within the range of 10-20 m / s. A HEPA high-efficiency filter is installed on the pipeline, with a filtration efficiency of ≥99.97%, which can filter PM2.5 particles and harmful gases such as formaldehyde and benzene, protecting the respiratory health of medical staff; When the smoke concentration is detected to be >100 mg / m³, the system automatically starts the smoke exhaust device, and the wind speed is set to 12 m / s when the concentration is 100-150 mg / m³, 15 m / s when the concentration is 150-200 mg / m³, 18 m / s when the concentration is 200-300 mg / m³, and 20 m / s when the concentration is >300 mg / m³, and a voice reminder of "high smoke concentration" is issued, and it is suggested to pause the operation for 10 seconds, and continue the operation when the concentration is below 150 mg / m³, to avoid operation errors caused by smoke blocking the surgical field, especially for long-term obstetric surgery (such as complex cesarean section).

[0028] Further, the dynamic power regulation and safety intervention module is also configured to include a multi-mode switching mechanism, setting three special modes of fine cutting, rapid coagulation, and blood vessel sealing, which can be switched by a foot switch with a response time ≤0.2 seconds; The fine cutting mode is suitable for steps such as uterine myometrial incision that require precise operation, using a straight blade (1 mm in diameter), with a continuous sine wave output, a power fluctuation rate controlled within ±5%, and a blade vibration frequency of 10 Hz to reduce tissue traction and achieve neat cutting edges; The rapid coagulation mode is suitable for small-area bleeding during surgery (such as capillary bleeding), with pulse output, a pulse cycle fixed at 0.5 seconds, and a pulse width dynamically adjusted according to the bleeding situation, set to 0.05-0.1 seconds for less bleeding and 0.2-0.3 seconds for more bleeding, to avoid excessive coagulation leading to thick tissue scabbing; The blood vessel sealing mode is suitable for blood vessels with a diameter of 2-5 mm (such as uterine artery branches), which is measured in real time by intraoperative ultrasound, with an output power of 25W for a 2mm diameter, 30W for a 3mm diameter, 35W for a 4mm diameter, and 40W for a 5mm diameter. The blade is required to be in close contact with the blood vessel wall during operation, with a contact force controlled within 1-1.5N, and a continuous action of 3-5 seconds to complete the sealing. After sealing, the system automatically detects the blood flow signal of the blood vessel and prompts "sealing complete" after confirming no blood flow, to achieve precise operation in different surgical scenarios and reduce intraoperative bleeding.

[0029] Further, the fetal vital sign linkage monitoring module is further configured to include electromagnetic interference shielding measures, an RC low-pass filter circuit is additionally arranged in the electrotome output loop, the resistance value is 1kΩ, the capacitance value is 10μF, and the cutoff frequency is 1MHz, so that the high-frequency interference signals generated during the operation of the electrotome can be effectively filtered out; a manganese-zinc ferrite magnetic ring is sleeved on the signal line of the fetal heart monitor, the inner diameter of the magnetic ring is 8mm, the outer diameter is 15mm, the length is 20mm, the magnetic permeability is 5000H / m, and the influence of common-mode interference on the fetal heart signal is reduced; The system detects the signal-to-noise ratio of the fetal heart signal once every 50ms, and the signal-to-noise ratio needs to be ≥30dB under normal working conditions; when the signal-to-noise ratio is <30dB, the output frequency of the electrotome is automatically adjusted to 400kHz (avoiding the working frequency band of 300kHz of the fetal heart monitor), and the display screen is prompted to "increase electromagnetic interference, please adjust the position of the electrotome", and the relative distance between the current electrotome and the fetal heart probe is marked, and it is suggested that the distance between the two should be kept above 15cm; In addition, the fetal heart monitoring data adopts differential signal transmission, which further reduces interference, so as to realize the accuracy of fetal heart rate monitoring and avoid fetal heart misjudgment caused by electrotome interference, thereby providing double protection for the safety of the fetus.

[0030] A safety control method of a high-frequency electrotome system for obstetrics is applied to tissue cutting and coagulation operation in obstetric surgery, and is characterized by comprising the following steps: Preoperative tissue characteristic detection and parameter presetting step: the surgical area is scanned by an ultrasonic Doppler probe to obtain the distribution data of the uterine muscle layer, the placenta attachment site and the adjacent blood vessels, and the tissue thickness, blood vessel density and impedance baseline value are determined, wherein the tissue thickness measurement accuracy is controlled within ±0.1mm, the blood vessel density is measured in terms of the number of blood vessel cross sections per square millimeter, and the impedance baseline value is obtained by taking the average value of three repeated measurements, and the range is set to 500-2000Ω; based on the detection data, the system automatically matches the preset parameter library, and the initial cutting power value is set to 30-50W and the initial coagulation power value is set to 20-40W for the lower uterine segment cesarean section surgery, and the electrode plate contact pressure threshold value is adjusted according to the gestational age, the threshold value is set to 0.3-0.5N when the gestational age is ≤37 weeks, and the threshold value is set to 0.5-0.7N when the gestational age is >37 weeks, so that the electrode plate can be in good contact with the skin of the pregnant woman and excessive compression can be avoided; Intraoperative real-time multi-parameter monitoring step: The integrated sensor module is used to synchronously collect the electrotome working parameters and tissue reaction data, wherein the current monitoring accuracy is ±1 mA, the voltage monitoring accuracy is ±1 V, and the frequency is stabilized at 300-500 kHz; the infrared temperature detector is used to monitor the temperature of the action point of the knife head in real time, the sampling frequency is 100 Hz, the temperature measurement range is 30-150 °C, and the accuracy is ±0.5 °C; the contact impedance of the electrode plate is monitored at the same time, and the data is updated every 50 ms, and when the impedance value exceeds the baseline value by ±20%, the preliminary warning is triggered; in addition, the pressure sensor is used to monitor the contact force between the knife head and the tissue in real time, the range is 0-5 N, the accuracy is ±0.1 N, and the excessive damage to the tissue caused by excessive contact force is avoided; Dynamic power regulation and safety intervention step: the system starts the closed-loop regulation mechanism according to the real-time monitoring data, when the tissue temperature exceeds 60 °C, the output power is automatically reduced by 2-5 W for every 1 °C increase, until the temperature stabilizes at 50-55 °C; when an area with a blood vessel density of >5 / mm² is detected, the system automatically switches to the coagulation mode, and the power is limited to 20-30 W; if the electrode plate contact impedance exceeds the normal range for 3 seconds, the system first issues an audible and visual alarm, the alarm sound pressure level is 80-90 dB, the alarm light flashing frequency is 2 Hz, and if the fault is not eliminated within 5 seconds, the output is automatically cut off; for the operation near the uterine artery, a 5 mm safety distance monitoring is set, when the knife head enters the safety distance range, the power is forced to reduce to 50% of the initial value, and the vibration prompt is started, the vibration frequency is 50 Hz; Fetal vital sign linkage monitoring step: the fetal heart rate data is collected by the fetal heart monitor in real time, the sampling frequency is 1 Hz, and the normal range is set to 110-160 times / min, when the electrotome is started, the fetal heart monitoring data is synchronously transmitted to the high-frequency electrotome system, if the fetal heart rate fluctuates by >20 times / min and lasts for more than 10 seconds, the system automatically reduces the power to 30% of the initial value, and highlights the fetal heart abnormality mark on the display screen; if the heart rate fluctuation lasts for 30 seconds without relief, the system is forced to shut down until the heart rate returns to the normal range and the physician confirms that it can be restarted; Emergency handling and operation recording step: a double emergency shutdown mechanism is set, including a foot switch emergency brake and a handheld knife head button brake, the response time is ≤0.1 second, and after shutdown, the system automatically records all parameters at the shutdown time; during the operation, the operation data is automatically saved every 10 seconds, including power, temperature, time, knife head position coordinates, etc., the data storage format is encrypted CSV file, and the storage period is not less than 5 years; after the operation, an operation report is automatically generated, including the parameter adjustment curve, the warning event record and the fetal heart rate correlation analysis, for postoperative evaluation and traceability.

[0031] Further, it further includes a three-dimensional operation trajectory reconstruction step: a six-axis gyroscope and a three-axis acceleration sensor are built in the knife head, the gyroscope range is ±2000° / s, the resolution is 0.01° / s, the acceleration sensor range is ±16g, the resolution is 1mg, and the sampling frequency is 100Hz, and the angular velocity and acceleration data of the knife head are collected in real time; A three-dimensional coordinate system is established with the midpoint of the edge of the operating table as the origin, the X axis points to the head of the pregnant woman along the long axis of the operating table, the Y axis points to the left along the wide axis of the operating table, and the Z axis is perpendicular to the operating table and upward, the angular velocity and acceleration data are converted into three-dimensional coordinates of the knife head through integral operation, and the coordinate accuracy is ±0.5mm; After the operation, the knife head trajectory is superimposed on the anatomical structure of the uterus, placenta and blood vessels combined with the preoperative ultrasonic tomographic image, a three-dimensional operation path diagram is generated, the power adjustment point is marked with red, the warning position is marked with yellow flicker, and the power, temperature and contact force data of each position are marked; The reconstructed data can be exported in STL format, supports synchronous playback with the operation video, and can drag the time axis to view the operation details and parameter changes at any time during playback, provides visual data support for operation review, complication analysis and novice physician skill training, and is especially helpful for summarizing the safety experience of electrotome operation in cesarean section.

[0032] Further, it further includes a physician operation proficiency evaluation step: the knife head moving speed v_i is collected by the sensor built in the knife head every 50ms, the sampling number n is greater than or equal to 100 times to ensure statistical validity, and the average moving speed v_avg is dynamically adjusted according to the operation steps, which is set to 8mm / s when cutting the uterine muscle layer, 5mm / s when coagulating blood, and 3mm / s when closing the blood vessel; The physician proficiency is evaluated by calculating the operation stability index, and the operation stability index is calculated in the following manner Wherein W is the operation stability index, which is dimensionless; v_i is the knife head moving speed of the i-th sampling, which is in mm / s; v_avg is the average moving speed, which is in mm / s; and n is the sampling number; W is divided into three levels, W≤0.2 is stable operation, maintaining the normal power upper limit; 0.2 Record each physician's operation data, recalculate W every 10 operations, when W is less than or equal to 0.2 for three times in succession, automatically restore the upper limit of power and reduce the path guidance frequency, gradually reduce the safety redundancy, help the novice physician to improve the operation proficiency under the premise of safety, and provide objective data basis for the physician skill examination of the hospital.

[0033] The above merely illustrates the preferred embodiments of the present application, but the protection scope of the present application is not limited thereto, any skilled person in the art can make equivalent replacement or change within the technical range disclosed by the present application according to the technical solution and the inventive concept of the present application, which should be covered within the protection scope of the present application.

Claims

1. A high-frequency electrosurgical unit for obstetric use, characterized in that, Includes the following modules: Preoperative tissue characteristic detection and parameter setting: The surgical area is scanned by an ultrasound Doppler probe to obtain data on the distribution of the myometrium, placental attachment site and adjacent blood vessels. Based on the detection data, the system automatically matches the preset parameter library and presets the initial values ​​of cutting power and coagulation power for lower segment cesarean section surgery, while adjusting the electrode contact pressure threshold according to the gestational age. Intraoperative real-time multi-parameter monitoring is implemented, using an integrated sensor module to synchronously collect electrosurgical operating parameters and tissue reaction data; the temperature of the tip's point of action is monitored in real time via an infrared thermometer; and the contact impedance of the electrode plate is monitored simultaneously, triggering an initial warning when the impedance value exceeds a certain range of the baseline value. In addition, the contact force between the blade and the tissue is monitored in real time using a pressure sensor; Dynamic power adjustment and safety intervention: The system activates a closed-loop adjustment mechanism based on real-time monitoring data. When the tissue temperature exceeds the limit, the output power is automatically reduced. When a high vascular density area is detected, the system automatically switches to coagulation mode and limits the power. Safety distance monitoring is set for operations near the uterine artery. When the blade enters the safe distance range, the power is forcibly reduced and a vibration prompt is activated. The system is linked to fetal vital signs monitoring. Fetal heart rate data is collected in real time by a fetal heart monitor. When the electrosurgical unit is started, the fetal heart rate monitoring data is transmitted to the high-frequency electrosurgical unit simultaneously. If the fetal heart rate fluctuates abnormally and continues for a set time, the system will automatically reduce the power and highlight the abnormality mark. If the heart rate fluctuation does not subside, the system will be forcibly shut down and restarted after the heart rate recovers and is confirmed by the doctor. Emergency handling and operation records are implemented, with a dual emergency shutdown mechanism that automatically records all parameters at the time of shutdown; data is stored in an encrypted CSV file format; and operation reports are automatically generated postoperatively.

2. The high-frequency electrosurgical unit for obstetric use according to claim 1, characterized in that, It also includes a tissue thermal damage risk assessment unit, which collects temperature data through the multi-point sampling function of an infrared thermometer, and distinguishes between continuous and intermittent contact time. The output current is calculated using the effective current to eliminate the interference of peak current on the evaluation results; This unit optimizes power regulation by calculating the thermal damage index, which is calculated as follows: H represents the thermal damage index, which is classified into three risk levels. k1 is the temperature coefficient; T is the tissue temperature; t is the contact time between the blade and the tissue; k2 is the current coefficient; I is the effective output current; d is the tissue depth.

3. The high-frequency electrosurgical unit for obstetric use according to claim 1, characterized in that, It also includes a dynamic assessment module for electrode contact quality. This module uses a capacitive sensor to scan the contact area between the electrode and the mother's skin. The standard contact area Sstandard is adjusted according to the electrode type to adapt to different specifications of neutral electrodes. The rated pressure Prated is subdivided according to gestational age. This module judges the contact quality by calculating the contact safety factor, which is calculated as S = Sactual / Sstandard × (1 - Pdeviation / Prated), where S is the contact safety factor; Sactual is the actual contact area; Sstandard is the standard contact area; Pdeviation is the deviation between the actual pressure and the rated pressure; and Prated is the rated pressure. When S < 0.6, the system determines that the contact is poor. In addition to issuing an alarm, it also displays a thermal map of the poor contact area on the display screen to guide medical staff to adjust the electrode position or increase the contact pressure.

4. The high-frequency electrosurgical unit for obstetric use according to claim 1, characterized in that, The preoperative tissue characteristic detection also includes elastic modulus measurement, using shear wave elastography technology to cover common obstetric surgical areas such as the lower uterine segment, cervix, and placental attachment. The system establishes a database corresponding to elastic modulus and tissue type, and automatically matches the feed speed of the cutting head according to the detected tissue type. The feed speed is limited to 5 mm / s for dense tissue with an elastic modulus > 50 kPa; the feed speed is set to 10-15 mm / s for loose tissue with an elastic modulus < 20 kPa; and the feed speed is set to 8-12 mm / s for medium-textured tissue with an elastic modulus of 20-50 kPa. At the same time, the feed speed adjustment is linked to the cutting head contact force monitoring. When the contact force exceeds 2 N, the feed speed is reduced to 5 mm / s regardless of the elastic modulus.

5. The high-frequency electrosurgical unit for obstetric use according to claim 1, characterized in that, The intraoperative real-time multi-parameter monitoring also includes smoke concentration detection, using a laser scattering smoke detector; the system's matching smoke exhaust device is a universally adjustable smoke exhaust pipe, with a HEPA high-efficiency filter installed on the pipe; when the detected smoke concentration is >100mg / m³, the system automatically starts the smoke exhaust device and simultaneously suggests pausing the surgery for 10 seconds.

6. The high-frequency electrosurgical unit for obstetric use according to claim 1, characterized in that, The dynamic power adjustment also includes a multi-mode switching mechanism, setting three dedicated modes: cutting, coagulation, and vascular closure, which can be switched with one button via a foot switch. The cutting mode is adapted to the precise operation of myometrial incision, using a straight blade and outputting a continuous sine wave waveform. The coagulation mode is adapted to small-area bleeding during the operation, using pulsed output, with the pulse width dynamically adjusted according to the bleeding situation. The system measures the vessel diameter in real time via intraoperative ultrasound, requiring the blade to be in close contact with the vessel wall during operation, with the contact force controlled at 1-1.5N. After closure, the system automatically detects the blood flow signal of the vessel.

7. The high-frequency electrosurgical unit for obstetric use according to claim 1, characterized in that, The fetal vital signs linkage monitoring also includes electromagnetic interference shielding measures; a manganese-zinc ferrite magnetic ring is wrapped on the signal line of the fetal heart monitor; the system checks the signal-to-noise ratio of the fetal heart signal every 50ms, and at the same time prompts "Electromagnetic interference is increasing, please adjust the electrosurgical position" on the display screen, and marks the relative distance between the current electrosurgical and the fetal heart probe; in addition, the fetal heart monitoring data is transmitted using differential signals.

8. A safety control method for an obstetric high-frequency electrosurgical unit system according to any one of claims 1-7, characterized in that, Includes the following steps: Preoperative tissue characteristic detection and parameter preset steps: The surgical area is scanned using an ultrasound Doppler probe to obtain the distribution data of the myometrium, placental attachment site and adjacent blood vessels; based on the detection data, the system automatically matches the preset parameter library; Intraoperative real-time multi-parameter monitoring steps: An integrated sensor module is used to synchronously collect electrosurgical operating parameters and tissue reaction data; an infrared thermometer is used to monitor the temperature of the tip in real time; and the contact impedance of the electrode plates is monitored simultaneously. Dynamic power adjustment and safety intervention steps: The system activates a closed-loop adjustment mechanism based on real-time monitoring data. When the tissue temperature exceeds 60°C, the output power is automatically reduced; when an area with a blood vessel density > 5 vessels / mm² is detected, the system automatically switches to coagulation mode. Fetal vital signs monitoring steps: Fetal heart rate data is collected in real time through a fetal heart monitor. When the electrosurgical unit is activated, the fetal heart rate monitoring data is synchronously transmitted to the high-frequency electrosurgical unit system. Emergency handling and operation record steps: A dual emergency shutdown mechanism is set up, including emergency braking via foot switch and braking via handheld blade button. After shutdown, the system automatically records all parameters at the time of shutdown; the data storage format is an encrypted CSV file.

9. The safety control method for the obstetric high-frequency electrosurgical unit system according to claim 8, characterized in that, The operation record also includes three-dimensional operation trajectory reconstruction. The blade head has a built-in six-axis gyroscope and a three-axis accelerometer. A three-dimensional coordinate system is established with the midpoint of the edge of the operating table as the origin. The angular velocity and acceleration data are converted into the three-dimensional coordinates of the blade head through integral calculation. After the operation, combined with the preoperative ultrasound tomography image, the blade head trajectory is superimposed on the anatomical structure of the uterus, placenta and blood vessels to generate a three-dimensional operation path map. The power adjustment point is marked in red, and the location of the warning is marked in yellow flashing. At the same time, the power, temperature and contact force data of each location are marked.

10. The safety control method for the obstetric high-frequency electrosurgical unit system according to claim 8, characterized in that, It also includes a physician proficiency assessment unit; this unit assesses physician proficiency by calculating an operational stability index, which is calculated as follows: Where W is the operational stability index, which is dimensionless; v_i is the cutting head movement speed of the i-th sample; v_avg is the average movement speed; the system divides W into three levels, with W≤0.2 indicating operational stability; 0.2 < W ≤ 0.3 indicates basically stable operation; W > 0.3 indicates unstable operation. The recommended operation path will be displayed on the screen, and a vibration warning will be issued when the blade deviates from the path. The unit will also record the operation data of each doctor. W will be recalculated after every 10 surgeries. When W is ≤ 0.2 for 3 consecutive times, the power limit will be automatically restored and the path guidance frequency will be reduced.

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