A bipolar nerve monitor dedicated to endoscopic thyroidectomy

Abstract

The present application provides a dedicated bipolar nerve monitor for endoscopic thyroidectomy, which relates to the technical field of medical devices. In the functional electrode unit, a radiofrequency output electrode is provided for applying high-frequency current for tissue cutting and coagulation, and a nerve stimulation electrode is provided for applying low-frequency current for nerve stimulation and monitoring. These two electrodes work together. The impedance detection electrode collects the voltage signal after the low-frequency current passes through the tissue, and the impedance modeling unit converts the collected voltage signal to obtain an impedance value. The position positioning module determines the position of the working point between the two extremes. During the operation, the initial impedance value of the working point at the current position is used as the type impedance to judge the tissue type of the working point. As the radiofrequency output electrode cuts the tissue, the impedance value change of the working point at the current position is monitored, and combined with the previously determined tissue type, so as to judge the tissue cutting result. In summary, the safety and overall efficiency of the surgical operation are improved.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, particularly to a bipolar endoscope for dedicated nerve monitoring in thyroid surgery. Background Art

[0002] With the development of minimally invasive surgical techniques, the requirements for surgical instruments in endoscopic thyroid surgery are getting higher and higher. In thyroid surgery, it is not only necessary to perform efficient and precise cutting and coagulation of tissues, but also to perform real-time monitoring and protection of important nerves such as the recurrent laryngeal nerve in the surgical area to avoid postoperative complications.

[0003] The bipolar endoscope for dedicated nerve monitoring in thyroid surgery is a high-end medical device designed specifically for thyroid surgery. The monopolar electrode is an integrated electrode with both functions of electrical stimulation and tissue coagulation and cutting. It can be used for coagulation and cutting operations on tissues in laparoscopic or robotic surgeries. With the assistance of nerve monitoring, it can accurately detect, identify, and protect motor nerves, thereby realizing a closed-loop control of "cutting - monitoring - feedback - adjustment" during the operation, pushing the risk of nerve injury to an extremely low level while maintaining the surgical efficiency. The electrode is equipped with a temperature control system, which can achieve low-temperature cutting during the operation, reduce intraoperative smoke, tissue adhesion, and thermal damage, thus helping surgeons achieve efficient surgery and functional protection, reducing the surgical risk, and improving the safety and effectiveness of the surgery.

[0004] In related technologies, the surgical equipment commonly used clinically at present mainly includes two categories: one is the electrosurgical equipment that uses high-frequency current for tissue cutting and coagulation, and the other is the equipment that uses low-frequency current for nerve stimulation and monitoring. However, high-frequency current is used for tissue cutting and coagulation, but it cannot take into account nerve stimulation and monitoring, and there is a risk of nerve injury. Although low-frequency current can be used for nerve stimulation and monitoring, the cutting efficiency is low and cannot meet the surgical requirements. Summary of the Invention

[0005] This application provides a bipolar endoscope for dedicated nerve monitoring in thyroid surgery, which improves the safety and overall efficiency of surgical operations.

[0006] This application provides a bipolar endoscope for dedicated nerve monitoring in thyroid surgery, including: a functional electrode unit, a signal detection unit, and a control and processing unit;

[0007] The functional electrode unit includes:

[0008] Radiofrequency output electrodes arranged at both ends, used for applying high-frequency current for tissue cutting and coagulation;

[0009] A nerve stimulation electrode arranged at either end, used for applying low-frequency current for nerve stimulation and monitoring;

[0010] The signal detection unit includes:

[0011] An impedance detection electrode disposed at the other extreme, corresponding to the nerve stimulation electrode, for collecting the voltage signal after the low-frequency current passes through the tissue;

[0012] An impedance modeling unit for converting the voltage signal into an impedance value;

[0013] The control processing unit includes:

[0014] A position positioning module for determining the position of the working point, where the working point is between the two extremes;

[0015] A central processing module for controlling the synchronous operation of the radio frequency output electrode and the nerve stimulation electrode; taking the initial impedance value of the working point at the current position as the type impedance; determining the tissue type of the working point at the current position through the type impedance; and determining the tissue cutting result according to the tissue type and the change of the impedance value of the working point at the current position.

[0016] Through the above technical solution, a radio frequency output electrode is provided in the functional electrode unit for applying high-frequency current for tissue cutting and coagulation, and a nerve stimulation electrode for applying low-frequency current for nerve stimulation and monitoring. These two electrodes work together, and the central processing module of the control processing unit controls their synchronous operation. The impedance detection electrode corresponding to the nerve stimulation electrode will collect the voltage signal after the low-frequency current passes through the tissue, and the impedance modeling unit will convert the collected voltage signal to obtain an impedance value, which can intuitively reflect the electrical characteristics of the current tissue. At the same time, the position positioning module determines the position of the working point between the two extremes, providing an accurate position reference for subsequent operations. During the operation, the initial impedance value of the working point at the current position is used as the type impedance to judge the tissue type of the working point. As the radio frequency output electrode cuts the tissue, the structure and state of the tissue will change, and its impedance value will also change accordingly. Monitor the change of the impedance value of the working point at the current position and combine the previously determined tissue type to judge the tissue cutting result. In summary, the safety and overall efficiency of the surgical operation are improved.

[0017] In some embodiments, it further includes: a tissue correction unit;

[0018] The central processing module is further configured to judge whether the change rate of the impedance value of the working point at the current position is within the preset cutting rate range according to the tissue type;

[0019] If it is not within the preset cutting rate range, the tissue correction unit is activated;

[0020] The tissue correction unit includes:

[0021] A feature extraction module for collecting the low-frequency limit resistance, high-frequency limit resistance, characteristic frequency, and frequency dispersion coefficient of the working point at the current position;

[0022] The Cole eigenvector module is used to input the low-frequency limit resistance, high-frequency limit resistance, characteristic frequency, and frequency dispersion coefficient into the Cole model to obtain the Cole eigenvector;

[0023] The tissue type determination module is used to match the Cole eigenvector with a preset tissue feature database to determine the new tissue type of the working point at the current position; the tissue feature database includes the Cole parameter ranges of different types of tissues;

[0024] The central processing module is also used to correct the tissue type using the new tissue type.

[0025] Through the above technical solution, if it is found that the change rate of the impedance value of the working point at the current position is not within the preset cutting rate range, the tissue correction unit is activated. In the tissue correction unit, the feature extraction module collects key parameters such as low-frequency limit resistance and high-frequency limit resistance. These parameters are transmitted to the Cole eigenvector module. After generating the Cole eigenvector, it is matched with the preset tissue feature database to determine the new tissue type, and then the central processing module corrects the original tissue type using the new tissue type. In this way, in the complex situation where tissue characteristics change, the tissue type can be determined more accurately, providing a reliable basis for subsequent surgical operations and ensuring the smooth progress of the surgery.

[0026] In some embodiments, the feature extraction module specifically includes:

[0027] The voltage response sub-module is used to collect the voltage response signals of the low-frequency current at different frequencies to obtain voltage amplitude and phase information;

[0028] The complex impedance value sub-module is used to calculate the complex impedance value based on the voltage amplitude and phase information. The complex impedance value is a complex-form impedance including the impedance magnitude and phase angle;

[0029] The plotting sub-module is used to plot the complex impedance value as a Nyquist plot. The Nyquist plot is a planar graph with the real part of the complex impedance value as the abscissa and the imaginary part of the complex impedance value as the ordinate;

[0030] The fitting sub-module is used to perform circular arc fitting on the Nyquist plot. Among them, the low-frequency limit resistance and high-frequency limit resistance are determined according to the intersection points of the circular arc and the abscissa, and the geometric features of the circular arc are the characteristic frequency and frequency dispersion coefficient.

[0031] Through the above technical solution, the voltage response sub-module in the feature extraction module collects the voltage response signals of the low-frequency current at different frequencies, and obtains the voltage amplitude and phase information. The complex impedance value sub-module uses this information to calculate the complex impedance value through calculation. The complex impedance value is presented in the form of a complex number containing the impedance magnitude and phase angle, and can more comprehensively and accurately reflect the electrical properties of the tissue. The plotting sub-module plots the Nyquist diagram based on the complex impedance value, constructs a plane graph with its real part as the abscissa and its imaginary part as the ordinate, and intuitively displays the relationship of the electrical properties of the tissue. The fitting sub-module performs circular arc fitting on the Nyquist diagram, and determines these key parameters such as the low-frequency limit resistance, high-frequency limit resistance, characteristic frequency, and frequency dispersion coefficient from it, which provide data support for the subsequent Cole feature vector module and tissue type determination module.

[0032] In some embodiments, the preset cutting rate range is determined by the tissue type.

[0033] Through the above technical solution, since the preset cutting rate range is determined by the tissue type, this means that during the entire surgical operation, for different types of tissues, the central processing module 310 will preset a matching cutting rate range according to their respective unique physiological characteristics, making it more accurate for inflammatory or pathological conditions.

[0034] In some embodiments, the position positioning module specifically includes:

[0035] A coordinate sub-module, configured to establish an initial coordinate transformation matrix according to the position coordinates of the detection point and the position coordinates of the working point;

[0036] An attitude angle sub-module, configured to collect the attitude angle data of the bipolar for endoscopic thyroid-specific nerve monitoring, and adjust the initial coordinate transformation matrix according to the attitude angle data to obtain a real-time coordinate transformation matrix;

[0037] A position resolver sub-module, configured to substitute the real-time position coordinates of the detection point into the real-time coordinate transformation matrix, and calculate the position of the working point.

[0038] Through the above technical solution, the coordinate sub-module in the position positioning module will first establish an initial coordinate transformation matrix based on the position coordinates of the detection point and the position coordinates of the working point, which is the basic framework for determining the position of the working point. Subsequently, the attitude angle sub-module collects the attitude angle data of the bipolar for endoscopic thyroid-specific nerve monitoring. Considering that the attitude of the device will change during use, this module adjusts the initial coordinate transformation matrix according to these angle data to obtain a real-time coordinate transformation matrix, enabling it to adapt to the actual attitude of the device. Finally, the position resolver module substitutes the real-time position coordinates of the detection point into the real-time coordinate transformation matrix to accurately calculate the position of the working point. Through the sequential cooperation of these sub-modules, even if position sensors cannot be placed at both ends due to space limitations, the position of the working point can still be accurately determined, providing an accurate position reference for subsequent electrode operations and surgical-related work.

[0039] In some embodiments, it further includes: a tissue positioning module;

[0040] The nerve stimulation electrode includes a plurality of stimulation sub-electrodes;

[0041] The impedance detection electrode includes a plurality of detection sub-electrodes. If a detection sub-electrode receives a counter stimulation sub-electrode, it is a counter electrode pair. If a detection sub-electrode receives a non-counter stimulation sub-electrode, it is an oblique electrode pair;

[0042] The tissue positioning module is used to calculate the voltage difference between the first voltage signal obtained by the counter electrode pair passing through the target tissue and the second voltage signal obtained by the oblique electrode pair;

[0043] According to a preset voltage-distance attenuation function, use the voltage difference to calculate the distance difference between the first distance value from the counter electrode pair to the target tissue and the second distance value from the oblique electrode pair to the target tissue;

[0044] According to the distance difference and the preset distance between the counter electrode pair and the oblique electrode pair, calculate the first distance value or the second distance value;

[0045] Determine the position information of the target tissue according to the position information of the counter electrode pair and the first distance value or determine the position information of the target tissue according to the position information of the oblique electrode pair and the second distance value.

[0046] Through the above technical solution, voltage signals obtained from the counter electrode pairs and oblique electrode pairs formed by a plurality of stimulation sub-electrodes in the nerve stimulation electrode and a plurality of detection sub-electrodes in the impedance detection electrode are received. First, calculate the voltage difference, then calculate the distance difference according to a preset voltage-distance attenuation function, and further determine the distance value of the target tissue, and finally clarify the position information of the target tissue. Thus, the position of the target tissue is presented, facilitating doctors' reference and improving the accuracy of medical operations.

[0047] In some embodiments, the steps of controlling the synchronous operation of the radiofrequency output electrode and the nerve stimulation electrode specifically include:

[0048] Controlling the radiofrequency output electrode and the nerve stimulation electrode to interactively operate.

[0049] Through the above technical solution, this interactive operation mode enables the two to be seamlessly connected in different surgical stages, giving full play to their respective functions in tissue treatment and nerve monitoring, avoiding the situation of uncoordinated operations and neglecting one thing while attending to another, thereby improving the coherence and accuracy of the entire surgical process and better ensuring the surgical effect.

[0050] In some embodiments, the central processing module is specifically configured to obtain the radiofrequency cutting parameters of the high-frequency current and the action time of the high-frequency current. The radiofrequency cutting parameters include amplitude and frequency;

[0051] Determine the energy accumulation value according to the radiofrequency cutting parameters and the action time;

[0052] Determine the heat conduction characteristics according to the tissue type;

[0053] Calculate the time correction coefficient by combining the heat conduction characteristics and the action time;

[0054] Determine the safe waiting time according to the energy accumulation value and the time correction coefficient.

[0055] Through the above technical solution, the central processing module first obtains the radiofrequency cutting parameters of the high-frequency current (including key elements such as amplitude and frequency) and the action time of the high-frequency current, and accurately calculates the energy accumulation value by combining the two, which reflects the degree of energy impact of radiofrequency cutting on tissues. At the same time, determine the heat conduction characteristics according to the tissue type, and then calculate the time correction coefficient in combination with the action time. This coefficient comprehensively considers the tissue's ability to conduct heat and the influence of the action time. Finally, determine the safe waiting time according to the energy accumulation value and the time correction coefficient. In the case where the high-frequency current cuts to make the tissue heat up and interference effects occur on the electrode surface, through the calculated waiting time, it is ensured that reliable subsequent operations such as nerve monitoring are carried out after the electrical characteristics of the tissue return to stability and the interference effects are eliminated, effectively ensuring the accuracy of the nerve monitoring results.

[0056] In some embodiments, the time correction coefficient is the product of the reference coefficient, the time ratio coefficient, and the ratio of the thermal conductivity coefficient; the time ratio coefficient is the ratio of the action time to the reference time plus 1; the ratio of the thermal conductivity coefficient is the ratio of the heat conduction characteristics to the reference heat conduction characteristics;

[0057] The safe waiting time is the product of the basic cooling time, the time correction coefficient, and the energy ratio coefficient; the energy ratio coefficient is the ratio of the energy accumulation value to the reference energy plus 1; the basic cooling time is selected according to the tissue type;

[0058] ;

[0059] Wherein, is the safety waiting time, is the basic cooling time, is the time correction coefficient, is the energy ratio coefficient, is the reference coefficient, is the time ratio coefficient, is the acting time, is the reference time, is the ratio of thermal conductivity, is the thermal conductivity characteristic, is the reference thermal conductivity characteristic, is the energy accumulation value, is the reference energy.

[0060] Through the above technical solution, the time correction coefficient is determined by the product of the reference coefficient and the time ratio coefficient and the ratio of thermal conductivity, where the time ratio coefficient takes into account the ratio of the acting time to the reference time plus 1, reflecting the influence of the actual acting time on the whole; the ratio of thermal conductivity reflects the ratio of the tissue thermal conductivity characteristic to the reference thermal conductivity characteristic, which is related to the heat conduction situation. The safety waiting time is obtained based on the product of the basic cooling time, the time correction coefficient and the energy ratio coefficient, and the energy ratio coefficient involves the ratio of the energy accumulation value to the reference energy plus 1. Through such a calculation method, it can closely combine the actual tissue state, energy accumulation and time and other situations, accurately determine the safety waiting time, make the waiting duration more in line with the actual changes of the tissue during the operation, and ensure to the greatest extent that each link of the operation is not interfered by factors such as tissue heating.

[0061] In some embodiments, the duration of the high-frequency current in one interaction process is determined according to the tissue type.

[0062] Through the above technical solution, accurately arranging the duration of the high-frequency current according to the tissue type in this way can avoid the situation that the high-frequency current in each round is too long, resulting in excessive cutting, ensure the efficiency and safety of the tissue processing link during the operation, and improve the overall operation quality.

[0063] One or more technical solutions provided in the embodiments of the present application have at least the following technical effects or advantages:

[0064] 1. The functional electrode unit is provided with a radiofrequency output electrode for applying high-frequency current for tissue cutting and coagulation, and a nerve stimulation electrode for applying low-frequency current for nerve stimulation and monitoring. These two electrodes work together and are controlled by the central processing module of the control processing unit to operate synchronously. The impedance detection electrode corresponding to the nerve stimulation electrode collects the voltage signal after the low-frequency current passes through the tissue. The impedance modeling unit converts the collected voltage signal to obtain an impedance value, which can intuitively reflect the electrical characteristics of the current tissue. At the same time, the position positioning module determines the position of the working point between the two extremes, providing an accurate position reference for subsequent operations. During the operation, the initial impedance value of the working point at the current position is used as the type impedance to judge the tissue type of the working point. As the radiofrequency output electrode cuts the tissue, the structure and state of the tissue will change, and its impedance value will also change accordingly. Monitoring the change in the impedance value of the working point at the current position and combining with the previously determined tissue type to judge the tissue cutting result. In summary, the safety and overall efficiency of the surgical operation are improved.

[0065] 2. If it is found that the change rate of the impedance value of the working point at the current position is not within the preset cutting rate range, the tissue correction unit is activated. In the tissue correction unit, the feature extraction module collects key parameters such as the low-frequency limit resistance and the high-frequency limit resistance. These parameters are transmitted to the Cole feature vector module. After generating the Cole feature vector, it is matched with the preset tissue feature database to determine the new tissue type. The central processing module then corrects the original tissue type with the new tissue type. In this way, in the complex situation where the tissue characteristics change, the tissue type can be more accurately determined, providing a reliable basis for subsequent surgical operations and ensuring the smooth progress of the operation.

[0066] 3. The coordinate sub-module in the position positioning module will first establish an initial coordinate transformation matrix based on the position coordinates of the detection point and the position coordinates of the working point. This is the basic framework for determining the position of the working point. Subsequently, the attitude angle sub-module collects the attitude angle data of the bipolar for endoscopic thyroid-specific nerve monitoring. Considering that the attitude of the device will change during use, this module adjusts the initial coordinate transformation matrix based on these angle data to obtain a real-time coordinate transformation matrix, enabling it to adapt to the actual attitude of the device. Finally, the position resolver module substitutes the real-time position coordinates of the detection point into the real-time coordinate transformation matrix to accurately calculate the position of the working point. Through the sequential cooperation of these sub-modules, even if position sensors cannot be placed at the two extremes due to space limitations, the position of the working point can still be accurately determined, providing an accurate position reference for subsequent electrode operations and surgical-related work. Description of the Drawings

[0067] Figure 1It is an exemplary hardware structure diagram of a bipolar dedicated to endoscopic thyroid nerve monitoring in an embodiment of the present application.

[0068] Figure 2 It is another exemplary hardware structure diagram of a bipolar dedicated to endoscopic thyroid nerve monitoring in an embodiment of the present application.

[0069] Figure 3 It is an exemplary specific hardware structure diagram of a feature extraction module in an embodiment of the present application.

[0070] Figure 4 It is an exemplary specific hardware structure diagram of a position positioning module in an embodiment of the present application. Detailed implementation manners

[0071] The terms used in the following embodiments of the present application are only for the purpose of describing specific embodiments and are not intended to limit the present application. As used in the specification and appended claims of the present application, the singular forms "a", "an", "the", "above-mentioned", "this", and "such" are intended to include the plural forms as well, unless the context clearly dictates otherwise. It should also be understood that the term "and / or" used in the present application refers to and includes any or all possible combinations of one or more of the listed items.

[0072] Hereinafter, the terms "first" and "second" are only used for descriptive purposes and cannot be construed as implying or suggesting relative importance or implicitly indicating the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include one or more of such features. In the description of the embodiments of the present application, unless otherwise specified, the meaning of "a plurality" is two or more.

[0073] Please refer to Figure 1 , Figure 1 It is an exemplary hardware structure diagram of a bipolar dedicated to endoscopic thyroid nerve monitoring in an embodiment of the present application.

[0074] The present application provides a bipolar dedicated to endoscopic thyroid nerve monitoring, including: a functional electrode unit 100, a signal detection unit 200, and a control processing unit 300;

[0075] The functional electrode unit 100 includes:

[0076] Radio frequency output electrodes 110 provided at both ends for applying high-frequency current for tissue cutting and coagulation;

[0077] A nerve stimulation electrode 120 provided at any one end for applying low-frequency current for nerve stimulation and monitoring;

[0078] Specifically, during the operation, when cutting and coagulating thyroid tissue and stimulating and monitoring the surrounding nerves are required, the radiofrequency output electrode 110 inside the functional electrode unit 100 outputs high-frequency current by connecting to the corresponding high-frequency current generating device. Relying on the thermal effect of the high-frequency current, tissue cutting and coagulation are achieved. For example, when removing a thyroid nodule, the high-frequency current is used to quickly cut the diseased tissue and stop the bleeding point. The nerve stimulation electrode 120 is connected to a low-frequency current source, and the low-frequency current is applied to the surrounding tissue to stimulate the nerve and observe the nerve's response, thereby judging whether the nerve function is normal. For example, during the operation, it is judged whether key nerves such as the recurrent laryngeal nerve have been accidentally damaged.

[0079] It should be noted that the front end of the bipolar dedicated to endoscopic thyroid nerve monitoring, that is, the two extreme ends, presents a clip-like shape structure. In this special structure, the radiofrequency output electrodes 110 are respectively arranged on the two extreme ends to ensure that during tissue cutting and coagulation operations, they can act simultaneously from both ends to achieve efficient and stable operation effects. The nerve stimulation electrode 120 is only arranged at one end to carry out stimulation and monitoring of the nerve at the corresponding position, and an impedance detection electrode 210 is arranged at the corresponding end to ensure that the tissue can be effectively processed during the operation while always paying attention to the nerve state.

[0080] The signal detection unit 200 includes:

[0081] The impedance detection electrode 210 arranged at the other extreme end, which is correspondingly arranged with the nerve stimulation electrode 120, is used to collect the voltage signal after the low-frequency current passes through the tissue;

[0082] The impedance modeling unit 220 is used to convert the voltage signal into an impedance value;

[0083] Specifically, during the surgical operation, when the nerve stimulation electrode 120 applies a low-frequency current through the tissue, the signal detection unit 200 starts to work. The impedance detection electrode 210 therein will correspond to the position of the nerve stimulation electrode 120 and collect the voltage signal after the low-frequency current passes through the tissue. This signal contains relevant information such as the electrical conductivity characteristics of the tissue. Then the impedance modeling unit 220 will obtain this voltage signal and use specific algorithms and models to convert it into an impedance value, which can intuitively reflect the current electrical characteristics of the tissue.

[0084] It should be noted that the impedance values of different tissue types are different, but generally within the range of 50Ω - 3kΩ, and at the same time, the impedance value of the nerve area is usually greater than 2kΩ;

[0085] The control processing unit 300 includes:

[0086] A position positioning module 320 is used to determine the position of the working point, which is between two extremes.

[0087] A central processing module 310 is used to control the synchronous operation of the radio frequency output electrode 110 and the nerve stimulation electrode 120; take the initial impedance value of the working point at the current position as the type impedance; determine the tissue type of the working point at the current position through the type impedance; and determine the tissue cutting result according to the tissue type and the change of the impedance value of the working point at the current position.

[0088] It should be noted that the initial impedance value of the working point at the current position is the type impedance because high-frequency current will carbonize the local tissue. Once the tissue is carbonized, its internal structure and composition change, and its electrical conductivity will decrease significantly, resulting in an increase in the impedance value of the local tissue. However, the working point at the current position refers to the specific position where the monitoring of this piece of tissue begins. It is the location of this piece of tissue in its natural and original state without being deeply affected by high-frequency current; the initial impedance value is the impedance value shown by this piece of tissue in this initial state without being disturbed by carbonization. Based on these two key factors, namely this original position and the corresponding initial impedance value, it can be used as the type impedance to accurately judge the tissue type, which is undoubtedly a reliable reference basis.

[0089] Specifically, at the beginning of the operation, the position positioning module 320 in the control processing unit 300 will determine the position of the working point between the two extremes, providing an accurate spatial reference for subsequent electrode operations. Then the central processing module 310 comes into play. It will control the synchronous operation of the radio frequency output electrode 110 and the nerve stimulation electrode 120, enabling tissue cutting, coagulation operations, and nerve stimulation and monitoring to be carried out simultaneously. The central processing module 310 will also take the initial impedance value of the working point at the current position as the type impedance, and determine the tissue type of the working point at the current position through this type impedance according to the impedance range characteristics of different tissue types. And during the operation, as the radio frequency output electrode 110 performs tissue cutting, the structure and state of the tissue change, and its impedance value also changes accordingly. The central processing module 310 will monitor this impedance value change in real time and combine the previously determined tissue type to judge the tissue cutting result.

[0090] In some embodiments, a database containing the impedance characteristics of different tissues at normal and cutting stages is constructed; the positioning module is used to determine the position of the working point. The initial impedance value is obtained before the operation to determine the tissue type, and the impedance value change is continuously monitored during the operation and recorded as a curve. The real-time impedance change curve is compared with the preset rules, and combined with the set threshold range, factors such as the operation time and electrode parameters are comprehensively considered to judge the cutting result.

[0091] It is worth noting that in actual use, whether the initial impedance value exceeds the preset initial impedance threshold, or the impedance value change of the working point during the operation exceeds the preset impedance value change threshold, the device will immediately suspend work. The reason for this setting is that when the initial impedance value exceeds the preset initial impedance threshold, it is very likely that the cutting operation has involved the area around the nerve. In addition, if the impedance value changes by more than the preset impedance value change threshold, this is likely to indicate that the high-frequency current cutting rate is too fast. This excessively fast cutting rate is not only difficult to ensure the accuracy of the cutting, but may also lead to excessive tissue cutting, bleeding and a series of adverse consequences. Therefore, through such threshold monitoring and automatic suspension of work mechanism, timely intervention can be made when potential risks arise, thereby maximizing the safety and effectiveness of the operation.

[0092] It can be seen that the functional electrode unit 100 is provided with a radio frequency output electrode 110 for applying high frequency current for tissue cutting and coagulation, and a nerve stimulation electrode 120 for applying low frequency current for nerve stimulation and monitoring. The two electrodes work together, and the central processing module 310 of the control processing unit 300 controls them to operate synchronously. The impedance detection electrode 210 corresponding to the nerve stimulation electrode 120 will collect the voltage signal after the low frequency current passes through the tissue, and the impedance modeling unit 220 will convert the collected voltage signal to obtain an impedance value, which can intuitively reflect the electrical characteristics of the current tissue. At the same time, the position positioning module 320 determines the position of the working point between the two extremes to provide an accurate position reference for subsequent operations. During the operation, the initial impedance value of the working point at the current position is used as the type impedance to determine the tissue type of the working point. As the radio frequency output electrode 110 performs tissue cutting, the structure and state of the tissue will change, and its impedance value will also change accordingly. Monitor the impedance value change of the working point at the current position, and combine it with the previously determined tissue type to determine the tissue cutting result. In summary, the safety and overall efficiency of the surgical operation are improved.

[0093] In the above embodiment, low-frequency current and high-frequency current work simultaneously to achieve the safety of surgical operation and the overall efficiency effect, but in actual use, due to the existence of inflammation or pathological conditions, the impedance characteristics of normal tissues may be changed, thereby making these tissues have similar impedance values under some physiological conditions. In this way, it is difficult to guarantee the accuracy of judging only by the impedance value.

[0094] See also Figure 2 , Figure 2 It is another exemplary hardware structure diagram of the endoscopic thyroid-specific nerve monitoring bipolar in the embodiment of the present application.

[0095] Therefore, in some other embodiments, it further includes: an organization correction unit 400;

[0096] The central processing module 310 is further configured to determine whether the impedance value change rate of the working point at the current position is within a preset cutting rate range according to the tissue type;

[0097] If it is not within the preset cutting rate range, the organization correction unit 400 is activated;

[0098] Specifically, during the operation, when the central processing module 310 determines the impedance value change rate of the working point according to the current tissue type and finds that it is not within the preset cutting rate range, it means that due to reasons such as tissue inflammation and lesions, the originally determined tissue type may be inaccurate. At this time, the organization correction unit 400 will be activated to start working.

[0099] In some embodiments, the central processing module 310 will also suspend the output of high-frequency current.

[0100] In some embodiments, the preset cutting rate range is determined by the tissue type.

[0101] It can be seen that since the preset cutting rate range is determined by the tissue type, this means that during the entire surgical operation, for different types of tissues, the central processing module 310 will preset a matching cutting rate range according to their respective unique physiological characteristics, making the situation for inflammation or lesions more accurate.

[0102] The organization correction unit 400 includes:

[0103] A feature extraction module 410, configured to collect the low-frequency limit resistance, high-frequency limit resistance, characteristic frequency, and frequency dispersion coefficient of the working point at the current position;

[0104] It should be noted that the premise of the feature extraction module 410 is that the nerve stimulation electrode 120 is used to release low-frequency currents of different frequencies. For example, only when the nerve stimulation electrode 120 continuously and stably outputs low-frequency currents of different frequencies, such as currents within a reasonable frequency range from low frequency to relatively high frequency, can the feature extraction module 410 detect the signal changes such as voltage and current after these currents pass through the tissue, and extract key parameters such as low-frequency limit resistance, high-frequency limit resistance, characteristic frequency, and frequency dispersion coefficient from them, so as to provide necessary data support for subsequent operations such as determining the tissue type. Therefore, in this case, the central processing module 310 will control the nerve stimulation electrode 120 to release low-frequency currents of different frequencies.

[0105] In some embodiments, the feature extraction module 410 specifically includes:

[0106] The voltage response sub-module 411 is used to collect the voltage response signals of low-frequency currents at different frequencies and obtain voltage amplitude and phase information;

[0107] Specifically, when the nerve stimulation electrode 120 releases low-frequency currents of different frequencies through the tissue, the voltage response sub-module 411 starts to work. It continuously collects the voltage response signals at each frequency to ensure that the small changes in the signals can be accurately captured. The collected original signals may contain noise and interference, so the voltage response sub-module 411 filters the signals to remove unnecessary high-frequency and low-frequency noises. Then, through signal processing algorithms such as phase-locked loop technology or Fourier transform, the voltage amplitude and phase information are extracted from the processed signals. These information reflect the response characteristics of the tissue to low-frequency currents of different frequencies and are the basis for calculating the complex impedance value in the follow-up.

[0108] The complex impedance value sub-module 412 is used to calculate the complex impedance value according to the voltage amplitude and phase information. The complex impedance value is a complex-form impedance that includes the impedance magnitude and the phase angle;

[0109] Specifically, according to Ohm's law in electricity, in an AC circuit, the complex impedance Z is equal to the ratio of the voltage U to the current I. And since both the voltage and the current have amplitude and phase information, the complex impedance is in a complex form. The complex impedance value sub-module 412 will combine the known current information (the amplitude and phase of the current are usually preset in the central processing module 310 or measured by other means), and use the rules of complex number operations for calculation. First, convert the amplitude and phase information of the voltage and the current into complex forms, and then perform the division operation to obtain the complex impedance value. The calculated complex impedance value contains two important information: the impedance magnitude and the phase angle. The impedance magnitude reflects the blocking effect of the tissue on the current, and the phase angle reflects the phase relationship between the voltage and the current. These two information together constitute the electrical property description of the tissue.

[0110] The plotting sub-module 413 is used to plot the complex impedance value as a Nyquist plot. The Nyquist plot is a planar graph with the real part of the complex impedance value as the abscissa and the imaginary part of the complex impedance value as the ordinate;

[0111] Specifically, the plotting sub-module 413 will extract the complex impedance value according to the real part and the imaginary part respectively. The real part corresponds to the abscissa of the graph, and the imaginary part corresponds to the ordinate of the graph. Then, according to the extracted data points, use the plotting algorithm to plot the corresponding points on the coordinate plane.

[0112] The fitting sub-module 414 is used to perform circular arc fitting on the Nyquist plot, where; the low-frequency limit resistance and the high-frequency limit resistance are determined according to the intersection points of the circular arc and the abscissa, and the geometric characteristics of the circular arc are the characteristic frequency and the frequency dispersion coefficient.

[0113] Specifically, after the drawing sub-module 413 transfers the drawn Nyquist plot to the fitting sub-module 414, the fitting sub-module 414 starts the circular arc fitting. First, the fitting sub-module 414 will select a suitable fitting algorithm, such as the least squares method, genetic algorithm, etc., to fit the data points on the Nyquist plot. The fitting objective is to find a circular arc such that the error between the circular arc and the data points on the Nyquist plot is minimized. According to the intersection points of the fitted circular arc and the abscissa, the low-frequency limit resistance and high-frequency limit resistance are determined. The low-frequency limit resistance corresponds to the left intersection point of the circular arc and the abscissa, and the high-frequency limit resistance corresponds to the right intersection point of the circular arc and the abscissa. The frequency at which the imaginary part of the impedance reaches the maximum value is the characteristic frequency, the characteristic frequency multiplied by 2π is the characteristic angular frequency, and the flattening degree of the circular arc is the frequency dispersion coefficient.

[0114] It can be seen that the voltage response sub-module in the feature extraction module 410 will collect the voltage response signals of the low-frequency current at different frequencies, and obtain the voltage amplitude and phase information. The complex impedance value sub-module uses this information to calculate the complex impedance value through calculation. The complex impedance value is presented in the form of a complex number containing the impedance magnitude and phase angle, and can more comprehensively and accurately reflect the electrical properties of the tissue. The drawing sub-module draws a Nyquist plot based on the complex impedance value, constructs a planar graph with its real part as the abscissa and its imaginary part as the ordinate, and intuitively displays the relationship of the electrical properties of the tissue. The fitting sub-module performs circular arc fitting on the Nyquist plot, and determines these key parameters such as the low-frequency limit resistance, high-frequency limit resistance, characteristic frequency, and frequency dispersion coefficient from it, which provide data support for the subsequent work of the cole feature vector module 420 and the tissue type determination module 430.

[0115] The cole feature vector module 420 is used to input the low-frequency limit resistance, high-frequency limit resistance, characteristic frequency, and frequency dispersion coefficient into the Cole model to obtain the Cole feature vector;

[0116] In some embodiments, the Cole model is:

[0117]

[0118] In the formula, is the Cole feature vector, is the high-frequency limit resistance, is the low-frequency limit resistance, is the imaginary unit, is the angular frequency in the characteristic frequency, is the characteristic angular frequency in the characteristic frequency, is the frequency dispersion coefficient.

[0119] The tissue type determination module 430 is configured to match the Cole feature vector with a preset tissue feature database to determine the new tissue type of the working point at the current position; the tissue feature database includes the Cole parameter ranges of different types of tissues.

[0120] Specifically, after the Cole feature vector module 420 generates and transmits the Cole feature vector, the tissue type determination module 430 starts to operate. It will access the preset tissue feature database, which details the corresponding Cole parameter ranges for different types of tissues (such as muscle tissue, adipose tissue, nerve tissue, etc.). These parameter ranges are obtained through a large number of experiments and clinical data statistical analyses. It finds the type corresponding to the tissue that is most similar to the current Cole feature vector, determines it as the new tissue type of the working point at the current position, and feeds this result back to the central processing module 310 for the central processing module 310 to perform subsequent tissue type correction operations.

[0121] The central processing module 310 is also configured to correct the tissue type using the new tissue type.

[0122] In some embodiments, the central processing module 310 activates its tissue type correction function. It receives this new tissue type information, then finds the corresponding original tissue type record position in the currently stored surgical-related tissue type records, and replaces the original tissue type with the new tissue type, so that all subsequent operations based on the tissue type, such as determining whether the impedance value change rate of the working point is normal, adjusting the working parameters of the radiofrequency output electrode 110 and the nerve stimulation electrode 120, etc., can be based on the new and more accurate tissue type. In this way, even in complex situations where the tissue impedance characteristics change due to factors such as inflammation and lesions and the initial tissue type judgment is inaccurate, the entire surgical operation can still rely on the corrected tissue type to ensure the safety and effectiveness of the surgery and avoid problems such as surgical mistakes caused by incorrect tissue type judgment.

[0123] It can be seen that if it is found that the impedance value change rate of the working point at the current position is not within the preset cutting rate range, the tissue correction unit 400 is activated. In the tissue correction unit 400, the feature extraction module 410 collects key parameters such as the low-frequency limit resistance and the high-frequency limit resistance. These parameters are transmitted to the Cole feature vector module 420, which generates a Cole feature vector and matches it with the preset tissue feature database to determine the new tissue type. The central processing module 310 then corrects the original tissue type with the new tissue type. In this way, in complex situations where the tissue characteristics change, the tissue type can be more accurately determined, providing a reliable basis for subsequent surgical operations and ensuring the smooth progress of the surgery.

[0124] Although the above embodiments can solve the problem of inaccurate tissue judgment caused by the presence of inflammation or lesions, in actual use, the volumes of the two extreme ends of the bipolar for endoscopic thyroid dedicated nerve monitoring are relatively small, and the position where it is located needs to place both the radio frequency output electrode 110 and the nerve stimulation electrode 120, so there is no extra space to place the position sensor.

[0125] In some embodiments, the position positioning module 320 specifically includes:

[0126] A coordinate sub-module 324, configured to establish an initial coordinate transformation matrix according to the position coordinates of the detection point and the position coordinates of the working point;

[0127] In some embodiments, by pre-connecting with a positioning device (such as an infrared-based positioning system) for communication, receiving the three-dimensional coordinate data of the detection point and the working point sent by it, and according to the dimension of the coordinate data and the setting of the coordinate origin, etc., the detection point coordinates and the working point coordinates are respectively filled into the corresponding positions according to the row and column rules of the matrix, and an initial coordinate transformation matrix is constructed.

[0128] An attitude angle sub-module 322, configured to collect the attitude angle data of the bipolar for endoscopic thyroid dedicated nerve monitoring, and adjust the initial coordinate transformation matrix according to the attitude angle data to obtain a real-time coordinate transformation matrix;

[0129] Specifically, during the operation, as long as the attitude of the device changes, the attitude angle sub-module starts to operate. It collects the attitude angle data of the device through a variety of built-in angle sensors (such as a gyroscope for detecting the angular velocity change of the device and an accelerometer for detecting the acceleration change, and the combination of the two can accurately calculate the attitude angle of the device). Then, according to the mathematical principle of spatial coordinate transformation, these processed attitude angle data are substituted into a specific coordinate transformation formula (such as a combined formula based on a rotation matrix, a translation matrix, etc.) and operated with the initial coordinate transformation matrix to adjust it, so as to obtain a real-time coordinate transformation matrix, which can reflect the accurate position relationship between the detection point and the working point of the device in the current attitude in real time.

[0130] A position resolver module 323, configured to substitute the real-time position coordinates of the detection point into the real-time coordinate transformation matrix to calculate the position of the working point.

[0131] It can be seen that the coordinate sub-module in the position positioning module 320 will first establish an initial coordinate transformation matrix based on the position coordinates of the detection point and the position coordinates of the working point, which is the basic framework for determining the position of the working point. Subsequently, the attitude angle sub-module collects the attitude angle data of the bipolar for endoscopic thyroid dedicated nerve monitoring. Considering that the attitude of the device will change during use, this module adjusts the initial coordinate transformation matrix according to these angle data to obtain a real-time coordinate transformation matrix, enabling it to adapt to the actual attitude of the device. Finally, the position resolver module substitutes the real-time position coordinates of the detection point into the real-time coordinate transformation matrix to accurately calculate the position of the working point. Through the sequential cooperation of these sub-modules, even if position sensors cannot be placed at both extremes due to space limitations, the position of the working point can still be accurately determined, providing an accurate position reference for subsequent electrode operations and surgical related work.

[0132] In the above embodiment, although the problem of having no extra space to place the position sensor can be solved. However, during the actual operation process, the two extremes of the bipolar for endoscopic thyroid dedicated nerve monitoring of the related device will be opened according to the operation of the user, and this operation will cause corresponding changes in its working point.

[0133] In some embodiments, the position positioning module 320 further includes:

[0134] A position optimization sub-module 324, configured to calculate the position offset of the working point according to the length of the extreme and the opening angle between the two extremes, and update the position of the working point using the offset.

[0135] In some embodiments, assume that the initial position of the working point in the closed state is P0(x0, y0, z0)

[0136] The opening angle θ will cause the working point to move along a specific direction. The new position P of the working point can be calculated through trigonometric relationships: the offset in the XY plane = L * sin(θ / 2), and the offset in the Z direction = L * (1 - cos(θ / 2)), where L is the length of the extreme.

[0137] It can be seen that the position optimization sub-module will obtain the position offset of the working point through a specific calculation method based on the two key factors of the length of the extreme and the opening angle between the two extremes, and then use this offset to update the position of the working point in real time. In this way, no matter how the two extremes change, the position of the working point can be adjusted in a timely and accurate manner, avoiding misjudgment due to the deviation of the working point position.

[0138] In the actual medical operation and usage scenarios, simply knowing the location of the working point is often insufficient. Because when doctors perform specific diagnosis and treatment behaviors, they need to accurately grasp the location information of the target tissue, which is used as an important reference basis. However, the current problem is that although the location of the working point can be determined, there is a lack of effective means to accurately obtain the location of the target tissue.

[0139] In some embodiments, it further includes: a tissue positioning module;

[0140] The nerve stimulation electrode includes a plurality of stimulation sub - electrodes;

[0141] The impedance detection electrode includes a plurality of detection sub - electrodes. If a detection sub - electrode receives an opposite stimulation sub - electrode, it forms an opposite electrode pair. If a detection sub - electrode receives a non - opposite stimulation sub - electrode, it forms an oblique electrode pair;

[0142] In some embodiments, the nerve stimulation electrode includes a plurality of parallel stimulation sub - electrodes. Similarly, the impedance detection electrode includes corresponding detection sub - electrodes. If a stimulation sub - electrode and a detection sub - electrode are opposite to each other, the stimulation sub - electrode and the detection sub - electrode are called an opposite electrode pair. If a stimulation sub - electrode and a detection sub - electrode are not opposite to each other, the stimulation sub - electrode and the detection sub - electrode are called an oblique electrode pair.

[0143] The tissue positioning module is used to calculate the voltage difference between the first voltage signal obtained by the opposite electrode pair passing through the target tissue and the second voltage signal obtained by the oblique electrode pair;

[0144] It should be noted that for the same target tissue, the distances of the opposite electrode pair and the oblique electrode pair are different. The farther away from the power source (which can be analogized to the electrode pair here), the lower the low - frequency current intensity will gradually be, and the corresponding voltage situation generated at the target tissue will also change. The difference in the distances of the opposite electrode pair and the oblique electrode pair to the target tissue causes the voltage signals excited at the target tissue to be different in strength, thus resulting in the appearance of a voltage difference.

[0145] According to the preset voltage - distance attenuation function, use the voltage difference to calculate the distance difference between the first distance value from the opposite electrode pair to the target tissue and the second distance value from the oblique electrode pair to the target tissue;

[0146] Among them, the preset voltage - distance attenuation function is a mathematical function relationship summarized based on a large amount of practical data, which describes the corresponding law between the change of the voltage signal (such as the magnitude of the voltage difference) and the change of the distance from the electrode to the target tissue.

[0147] According to the distance difference and the preset distances of the opposite electrode pair and the oblique electrode pair, calculate the first distance value or the second distance value;

[0148] It should be noted that, for the convenience of understanding, a geometric model similar to a triangle is constructed to visually present the positional relationship between the electrodes and the target tissue. Specifically, the opposing electrode pair can be regarded as a point in this triangle, the oblique electrode pair is also regarded as a point, and the target tissue is another point in the triangle.

[0149] The distance between the opposing electrode pair and the oblique electrode pair is known, just like the length of a certain side in a triangle is a fixed value determined in advance. The distance from the opposing electrode pair to the target tissue and the distance from the oblique electrode pair to the target tissue are respectively equivalent to the lengths of the other two sides in the triangle. Now, the difference between these two sides has been obtained. Based on such known conditions, that is, the length of one known side (the distance between the opposing electrode pair and the oblique electrode pair) and the difference between the other two sides, and according to the basic geometric principles of a triangle, such as the triangle inequality and the cosine theorem, etc., a system of equations can be constructed. By solving the system of equations, the specific distance value from the opposing electrode pair to the target tissue (i.e., the length of the corresponding side) and the specific distance value from the oblique electrode pair to the target tissue (i.e., the length of the other side) can be accurately calculated.

[0150] Determine the position information of the target tissue according to the position information of the opposing electrode pair and the first distance value or determine the position information of the target tissue according to the position information of the oblique electrode pair and the second distance value.

[0151] It should be noted that the position of the working point is known, so the position information of the opposing electrode pair and the position information of the oblique electrode pair are also known.

[0152] It can be seen that voltage signals acquired from the opposing electrode pair and the oblique electrode pair formed by several stimulating sub - electrodes in the nerve stimulation electrode and several detecting sub - electrodes in the impedance detection electrode are received. First, calculate the voltage difference, then calculate the distance difference according to the preset voltage - distance attenuation function, and then determine the distance value of the target tissue, and finally clarify the position information of the target tissue. Thus, the position of the target tissue is presented, which is convenient for doctors to refer to and improves the accuracy of medical operations. In some embodiments, high - frequency current and low - frequency current are output simultaneously. In the case where interference may occur, therefore, the steps of controlling the synchronous operation of the radio - frequency output electrode 110 and the nerve stimulation electrode 120 specifically include:

[0153] Control the radio - frequency output electrode 110 and the nerve stimulation electrode 120 to interactively work.

[0154] It can be seen that this interactive working mode can make the two seamlessly connect in different surgical stages, give full play to their respective functions in tissue processing and nerve monitoring, avoid the situation of incoordinated operation and attending to one thing and losing sight of another, thereby improving the coherence and accuracy of the entire surgical process and better ensuring the surgical effect.

[0155] However, in the actual use process, high-frequency current and low-frequency current are alternately conducted, which gives rise to a new problem. Radiofrequency cutting operation can cause tissue heating, thereby changing the electrical properties of local tissue, and interference effects will also occur on the electrode surface. It takes a certain amount of time to eliminate these effects, resulting in inaccurate impedance values measured by low-frequency current.

[0156] In some embodiments, the central processing module 310 is specifically configured to obtain radiofrequency cutting parameters of high-frequency current and the action time of high-frequency current, and the radiofrequency cutting parameters include amplitude and frequency;

[0157] Specifically, while the high-frequency current is performing radiofrequency cutting operation, a wired (such as transmitting data through a data line) or wireless (such as using wireless communication protocols such as Bluetooth, Wi-Fi, etc.) communication interface established with the radiofrequency output electrode 110 is used to send a parameter acquisition request instruction to the radiofrequency output electrode 110. After receiving the instruction, the radiofrequency output electrode 110 transmits back real-time parameter data such as the amplitude and frequency of the high-frequency current.

[0158] Determine the energy accumulation value according to the radiofrequency cutting parameters and the action time;

[0159] Specifically, the central processing module 310 records time through a built-in high-precision timer. When the high-frequency current stops acting, the timing is stopped, and the recorded action time data is sorted out. According to the pre-set energy calculation principle, parameters such as amplitude, frequency, and action time are substituted into the corresponding energy accumulation value calculation formula. For example, energy accumulation value = a certain coefficient × amplitude × frequency × action time. Here, the coefficient is determined through experiments and theoretical analysis according to different tissue types, device characteristics, etc. The calculated energy accumulation value can intuitively reflect the degree of energy impact on the tissue during this action time by the radiofrequency cutting operation, providing important basic data for subsequent operations such as judging the tissue heating situation and determining the safe waiting time.

[0160] Determine the heat conduction characteristics according to the tissue type;

[0161] Among them, determining the heat conduction characteristics according to the tissue type means that in the operation process related to the surgery, the central processing module 310 obtains relevant characteristic parameters that can reflect the heat conduction ability of the tissue corresponding to the specifically identified tissue type (such as muscle tissue, adipose tissue, glandular tissue, etc.). It refers to the operation step of obtaining key information such as thermal conductivity coefficient, which reflects the speed of heat conduction and heat transfer efficiency of the tissue, by querying a pre-set tissue characteristic database or using an established association model between tissue type and heat conduction characteristics, so as to provide a basic basis for accurately evaluating the diffusion and dissipation of heat in the tissue subsequently.

[0162] Calculate the time correction coefficient for the heat conduction characteristics and the action time;

[0163] In some embodiments, the time correction coefficient is the product of the reference coefficient, the time ratio coefficient, and the ratio of the thermal conductivity; the time ratio coefficient is the ratio of the action time to the reference time plus 1; the ratio of the thermal conductivity is the ratio of the heat conduction characteristics to the reference heat conduction characteristics;

[0164] From the perspective of parameter composition, the reference coefficient, as a unified adjustment parameter, can be globally calibrated according to different device characteristics to ensure general adaptability; the time ratio, through the design of adding 1 to the ratio of the action time to the reference time, can automatically follow the change of the operation duration and effectively reflect the heat accumulation effect; the thermal ratio, through the ratio of the actual heat conduction characteristics to the reference value, realizes the precise matching of the heat dissipation characteristics of different tissues.

[0165] In terms of the combined application of parameters, the product of the reference coefficient and the time ratio constructs an adaptive safety protection mechanism, which not only ensures basic safety but also can dynamically respond to the change of the operation duration; when this product is multiplied by the thermal ratio, the ability to identify tissue characteristics is obtained, thus realizing a more comprehensive adjustment function.

[0166] Determine the safe waiting time according to the energy accumulation value and the time correction coefficient.

[0167] In some embodiments, the safe waiting time is the product of the basic cooling time, the time correction coefficient, and the energy ratio coefficient; the energy ratio coefficient is the ratio of the energy accumulation value to the reference energy plus 1; the basic cooling time is selected according to the tissue type.

[0168] From the perspective of parameter composition, the basic cooling time, as an inherent heat dissipation time parameter of the tissue, accurately reflects the intrinsic thermal characteristics and basic heat dissipation requirements of different tissue types; the time correction coefficient provides a dynamic and precise adjustment ability by integrating the influence of the operation duration and the tissue heat conduction characteristics; the energy ratio coefficient, through the design of adding 1 to the ratio of the energy accumulation value to the reference energy, effectively quantifies the actual impact of the radio frequency energy input on the tissue cooling process.

[0169] In terms of parameter coordination, the product of the basic cooling time and the time correction coefficient constructs an intelligent tissue recognition and response mechanism, which not only ensures the accurate recognition of tissue characteristics but also realizes the dynamic adjustment of the change of operation conditions; when this product is multiplied by the energy ratio coefficient, the precise compensation ability for the energy accumulation effect is obtained, thus realizing a more comprehensive and precise control of the cooling time.

[0170] ;

[0171] In the formula, is the safe waiting time, is the basic cooling time, is the time correction coefficient, is the energy proportion coefficient, is the reference coefficient, is the time proportion coefficient, is the acting time, is the reference time, is the thermal conductivity proportion, is the thermal conductivity characteristic, is the reference thermal conductivity characteristic, is the energy accumulation value, is the reference energy.

[0172] It can be seen that the time correction coefficient is determined by the product of the reference coefficient, the time proportion coefficient and the thermal conductivity proportion. Among them, the time proportion coefficient takes into account the ratio of the acting time to the reference time plus 1, reflecting the influence of the actual acting time on the whole; the thermal conductivity proportion reflects the ratio of the tissue thermal conductivity characteristic to the reference thermal conductivity characteristic, which is related to the heat conduction situation. The safe waiting time is obtained based on the product of the basic cooling time, the time correction coefficient and the energy proportion coefficient. The energy proportion coefficient involves the ratio of the energy accumulation value to the reference energy plus 1. Through such a calculation method, it can closely combine the actual tissue state, energy accumulation and time and other situations, accurately determine the safe waiting time, make the waiting duration more in line with the actual changes of the tissue during the operation, and ensure that all links of the operation are not interfered by factors such as tissue heating to the greatest extent.

[0173] It should be noted that in some new embodiments, when the central processing module 310 monitors that the position of the working point changes beyond the threshold, it will promptly restart the synchronous operation of the radiofrequency output electrode 110 and the nerve stimulation electrode 120. And the working timing of the nerve stimulation electrode 120 is arranged before the radiofrequency output electrode 110, and the nerve stimulation electrode 120 works first, which can accurately detect the tissue and the surrounding nerve conditions in advance, obtain key information such as tissue electrical characteristics and nerve distribution, provide a reliable reference basis for the subsequent operation of the radiofrequency output electrode 110, reduce the risk of accidentally injuring important tissues such as nerves due to unclear conditions after the position change, and ensure the safety of the operation.

[0174] It can be seen that the central processing module 310 first obtains the radio frequency cutting parameters of the high-frequency current (including key elements such as amplitude and frequency) and the action time of the high-frequency current, and accurately calculates the energy accumulation value by combining the two, which reflects the degree of energy impact on the tissue caused by radio frequency cutting. At the same time, the thermal conductivity characteristics are determined according to the tissue type, and then the time correction coefficient is calculated in combination with the action time. This coefficient comprehensively considers the tissue's ability to conduct heat and the influence of the action time. Finally, the safe waiting time is determined based on the energy accumulation value and the time correction coefficient. In the case where the high-frequency current cuts to make the tissue heat up and interference effects occur on the electrode surface, through the calculated waiting time, it is ensured that reliable subsequent operations such as nerve monitoring are carried out after the electrical characteristics of the tissue return to stability and the interference effects are eliminated, effectively guaranteeing the accuracy of the nerve monitoring results.

[0175] In some embodiments, the duration of the high-frequency current in one interaction process is determined according to the tissue type.

[0176] It can be seen that arranging the duration of the high-frequency current accurately according to the tissue type in this way avoids the situation of excessive cutting caused by too long high-frequency current in each round, ensures the efficiency and safety of the tissue processing link during the operation, and improves the overall surgical quality.

Claims

1. A bipolar nerve monitor dedicated for endoscopic thyroidectomy, characterized in that, Comprising: A functional electrode unit, a signal detection unit, a control processing unit, and a tissue correction unit; The functional electrode unit includes: Radiofrequency output electrodes disposed at two extreme ends for applying high-frequency current for tissue cutting and coagulation; A nerve stimulation electrode disposed at any one extreme end for applying low-frequency current for nerve stimulation and monitoring; The signal detection unit includes: An impedance detection electrode disposed at the other extreme end, corresponding to the nerve stimulation electrode, for collecting voltage signals after low-frequency current passes through the tissue; An impedance modeling unit for converting the voltage signals into impedance values; The control processing unit includes: A position positioning module for determining the position of the working point, where the working point is between the two extreme ends; A central processing module for controlling the synchronous operation of the radiofrequency output electrode and the nerve stimulation electrode; taking the initial impedance value of the working point at the current position as the type impedance; determining the tissue type of the working point at the current position through the type impedance; and determining the tissue cutting result based on the tissue type and the change in the impedance value of the working point at the current position; The central processing module is further used to determine whether the change rate of the impedance value of the working point at the current position is within a preset cutting rate range according to the tissue type; If it is not within the preset cutting rate range, the tissue correction unit is activated; The tissue correction unit includes: A feature extraction module for collecting the low-frequency limit resistance, high-frequency limit resistance, characteristic frequency, and frequency dispersion coefficient of the working point at the current position; A Cole feature vector module for inputting the low-frequency limit resistance, the high-frequency limit resistance, the characteristic frequency, and the frequency dispersion coefficient into the Cole model to obtain a Cole feature vector; A tissue type determination module for matching the Cole feature vector with a preset tissue feature database to determine the new tissue type of the working point at the current position; the tissue feature database includes the Cole parameter ranges of different types of tissues; The central processing module is further used to correct the tissue type using the new tissue type.

2. The bipolar nerve monitor dedicated to endoscopic thyroidectomy according to claim 1, characterized in that: The feature extraction module specifically includes: A voltage response sub-module for collecting voltage response signals of low-frequency current at different frequencies to obtain voltage amplitude and phase information; A complex impedance value sub-module for calculating a complex impedance value according to the voltage amplitude and the phase information, where the complex impedance value is a complex-form impedance including impedance magnitude and phase angle; A plotting sub-module for plotting the complex impedance value as a Nyquist plot, where the Nyquist plot is a plane graph with the real part of the complex impedance value as the abscissa and the imaginary part of the complex impedance value as the ordinate; A fitting sub-module for performing circular arc fitting on the Nyquist plot, where; the low-frequency limit resistance and the high-frequency limit resistance are determined according to the intersection points of the circular arc and the abscissa, and the geometric features of the circular arc are the characteristic frequency and the frequency dispersion coefficient.

3. The bipolar endoscope thyroid dedicated nerve monitor according to claim 1, characterized in that: The preset cutting rate range is determined by the tissue type.

4. The bipolar endoscope thyroid dedicated nerve monitor according to claim 1, characterized in that: The position positioning module specifically includes: A coordinate sub-module for establishing an initial coordinate transformation matrix according to the position coordinates of the detection point and the position coordinates of the working point; The attitude angle sub-module is used to collect the attitude angle data of the bipolar endoscopic thyroid dedicated nerve monitor, and adjust the initial coordinate transformation matrix according to the attitude angle data to obtain a real-time coordinate transformation matrix; The position resolver module is used to substitute the real-time position coordinates of the detection point into the real-time coordinate transformation matrix to calculate the position of the working point.

5. The bipolar nerve monitor dedicated for endoscopic thyroidectomy according to claim 1, wherein: It further includes: The tissue localization module; The nerve stimulation electrode includes a plurality of stimulation sub-electrodes; The impedance detection electrode includes a plurality of detection sub-electrodes. If the detection sub-electrode receives the opposite stimulation sub-electrode, it is an opposite electrode pair. If the detection sub-electrode receives a non-opposite stimulation sub-electrode, it is an oblique electrode pair; The tissue localization module is used to calculate the voltage difference between the first voltage signal obtained by the opposite electrode pair passing through the target tissue and the second voltage signal obtained by the oblique electrode pair; According to the preset voltage-distance attenuation function, use the voltage difference to calculate the distance difference between the first distance value from the opposite electrode pair to the target tissue and the second distance value from the oblique electrode pair to the target tissue; According to the distance difference and the preset distance between the opposite electrode pair and the oblique electrode pair, calculate the first distance value or the second distance value; Determine the position information of the target tissue according to the position information of the opposite electrode pair and the first distance value or determine the position information of the target tissue according to the position information of the oblique electrode pair and the second distance value.

6. The bipolar endoscopic thyroid-specific nerve monitor according to claim 1, wherein The step of controlling the radiofrequency output electrode to work synchronously with the nerve stimulation electrode specifically includes: Controlling the radiofrequency output electrode to interact with the nerve stimulation electrode.

7. The bipolar endoscopic thyroid-specific nerve monitor according to claim 6, characterized in that, The central processing module is specifically used to obtain the radiofrequency cutting parameters of the high-frequency current and the action time of the high-frequency current. The radiofrequency cutting parameters include amplitude and frequency; Determine the energy accumulation value according to the radiofrequency cutting parameters and the action time; Determine the heat conduction characteristics according to the tissue type; Calculate the time correction coefficient based on the heat conduction characteristics and the action time; Determine the safe waiting time according to the energy accumulation value and the time correction coefficient.

8. The bipolar endoscope for special nerve monitoring of the thyroid according to claim 7, characterized in that, The time correction coefficient is the product of the reference coefficient, the time ratio coefficient, and the ratio of the heat conduction coefficients; the time ratio coefficient is the ratio of the action time to the reference time plus 1; The ratio of the heat conduction coefficients is the ratio of the heat conduction characteristics to the reference heat conduction characteristics; The safe waiting time is the product of the basic cooling time, the time correction coefficient, and the energy ratio coefficient; the energy ratio coefficient is the ratio of the energy accumulation value to the reference energy plus 1; The basic cooling time is selected according to the tissue type; ； Wherein, is the said safety waiting time, is the said basic cooling time, is the said time correction coefficient, is the said energy proportion coefficient, is the said reference coefficient, is the said time proportion coefficient, is the said acting time, is the said reference time, is the said thermal conductivity ratio, is the said thermal conductivity characteristic, is the said reference thermal conductivity characteristic, is the said energy accumulation value, is the said reference energy.

9. The bipolar endoscope thyroid-specific nerve monitor according to claim 6, characterized in that, Determine the duration of the high-frequency current in one interaction process according to the tissue type.

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