CN119564357B - Thyroid laryngeal recurrent nerve simulation marking system - Google Patents
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
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- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
- A61B2090/3904—Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
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Abstract
The invention discloses a thyroid recurrent laryngeal nerve simulation marking system, in particular to the field of recurrent laryngeal nerve simulation prompting and marking, which comprises a data input layer, a data processing layer and a data output layer; the data input layer comprises an electric stimulation module and a signal acquisition module, the data input layer is used for transmitting stimulation data and biological signals to the data processing layer, the data processing layer comprises a central control module, the data processing layer is used for outputting analysis results to the data output layer, and the data output layer comprises a positioning prompt module and a display and interaction module. The multi-electrode array and the tissue conductivity measuring unit are combined with a dynamic current distribution technology to realize the stimulation of a target nerve region, and the feedback control unit adjusts stimulation data according to the dynamic change of nerve response signals to form a closed-loop optimization mechanism, so that the problem of non-uniform stimulation caused by individual tissue difference of a patient is effectively solved.
Description
Technical Field
The invention relates to the technical field of recurrent laryngeal nerve simulation prompt and marking, in particular to a thyroid recurrent laryngeal nerve simulation marking system.
Background
In thyroid or cervical surgery, protection of recurrent laryngeal nerves is of great importance, however, the prior art mainly depends on experience of an operator or a simple stimulation and response detection method, so that localization and dynamic protection of nerves are difficult to realize, and current stimulation is uneven and monitoring of a stimulation process is lacked due to individual differences of patients, such as differences of fat layer thickness and subcutaneous liquid distribution.
Disclosure of Invention
In order to overcome the above-mentioned drawbacks of the prior art, an embodiment of the present invention provides a thyroid laryngeal recurrent nerve simulation marking system, which realizes the stimulation of a target nerve region by combining a multipolar electrode array and a tissue conductivity measurement unit and a dynamic current distribution technology, and simultaneously, a feedback control unit adjusts stimulation data according to the dynamic change of a nerve response signal to form a closed loop optimization mechanism, so as to solve the problems presented in the background art.
In order to achieve the aim, the invention provides the technical scheme that the thyroid laryngeal recurrent nerve simulation marking system comprises a data input layer, a data processing layer and a data output layer;
the data input layer is used for transmitting the stimulation data and the biological signals to the data processing layer;
The data processing layer is used for outputting analysis results to the data output layer;
the data output layer comprises a positioning prompt module and a display and interaction module, and is used for receiving the analysis result of the data processing layer and executing feedback;
the electric stimulation module comprises a multipolar electrode array, a current distribution unit and a tissue conductivity measurement unit, wherein the multipolar electrode array comprises at least two independent electrode pairs, and each independent electrode in the electrode pairs is used for independently regulating and controlling the current intensity by connecting the current distribution unit;
the signal acquisition module comprises an electrophysiological sensor array, a signal fusion and enhancement unit and a feedback control unit, wherein the electrophysiological sensor array is arranged around a stimulation area and is used for acquiring biological signals of nerve activities, the signal fusion and enhancement unit is used for amplifying the nerve signals, eliminating noise interference and converting the signals into digital output, the feedback control unit is used for receiving the biological signals of target nerves provided by the signal acquisition module and the stimulation data of the current electric stimulation module, calculating the deviation between the biological signal intensity and an expected effect through time sequence alignment and feature matching, and the feedback control unit adjusts the stimulation data according to the deviation, wherein the stimulation data comprises current intensity, frequency or activated electrode combinations, generates dynamic optimization instructions and transmits the dynamic optimization instructions to the electric stimulation module;
The neural response optimization closed loop model is constructed based on the feedback control unit and the signal fusion and enhancement unit and is expressed as follows:
;
Wherein the method comprises the steps of Deviation of the neural response signal from the target stimulus signal; representing a target stimulation signal applied by the electrical stimulation module; representing the neural response signal acquired by the signal fusion and enhancement unit; The rate of change of the target neural response signal over time; Weight parameters for static signal response; A weight parameter which is the dynamic signal change rate; , The time interval start point and the end point of the target stimulation signal and the nerve response signal.
In a preferred embodiment, the current distribution unit comprises a multichannel digital-to-analog converter and a power amplifier, wherein the multichannel digital-to-analog converter is used for converting preset stimulation data into current signals to be output;
The signal fusion and enhancement unit comprises a differential amplifier, a filter and an analog-to-digital converter, wherein the analog-to-digital converter is used for converting biological signals into digital signals for data processing, the differential amplifier is used for eliminating noise by a filter circuit, and the filter is used for eliminating environmental interference.
In a preferred embodiment, the central control module comprises a microcontroller MCU, a data storage unit and a communication interface, wherein the communication interface comprises an I2C bus and a UART interface, the I2C bus is used for connecting with the data input layer module to transmit control instructions, and the UART interface is used for connecting with the data output layer to transmit analysis results.
In a preferred embodiment, the positioning prompt module comprises a vibration unit and a status indicator lamp, wherein the vibration unit comprises a vibration motor, and prompts the risk of the approaching area of the nerve through the vibration frequency or the vibration intensity;
The display and interaction module is used for transmitting the running state of the system and the analysis result to a doctor for reading in a screen or audio mode.
In a preferred embodiment, the input of the multipolar electrode array is connected to the output of the current distribution unit by a wire, the input of the current distribution unit is connected to the output of the microcontroller MCU by an I2C bus, the output of the tissue conductivity measurement unit is connected to the input of the microcontroller MCU by an I2C bus;
The electrophysiological sensor array is connected with the input end of a differential amplifier of the signal fusion and enhancement unit through a wire and is used for collecting nerve activity signals of a target area, the differential amplifier of the signal fusion and enhancement unit is connected with a filter, the filter of the signal fusion and enhancement unit is connected with an analog-to-digital converter, the analog-to-digital converter of the signal fusion and enhancement unit is connected with a feedback control unit, and the feedback control unit is connected with a microcontroller MCU through an I2C bus;
The central control module is connected with the positioning prompt module through a UART interface, and is connected with the display and interaction module through the UART interface;
the power supply and protection module supplies power to the data input layer, the data processing layer and the data output layer through power supply lines.
In a preferred embodiment, a tissue conductivity distribution model is constructed based on the tissue conductivity measurement unit and the current distribution unit, which is expressed as:
;
Wherein the method comprises the steps of A conductivity distribution in three-dimensional space for the target region; Representing the constant alternating current injected by the pair of injection electrodes; representing the voltage difference recorded by the measurement electrode pair; is a geometric correction coefficient; to measure the amount of change in the voltage difference across the electrode pair; Is the amount of change in distance between the electrode pairs; is the gradient of the voltage difference along with the distance between the electrodes;
The neural response optimization closed loop model is constructed based on the feedback control unit and the signal fusion and enhancement unit and is expressed as follows:
;
Wherein the method comprises the steps of Deviation of the neural response signal from the target stimulus signal; representing a target stimulation signal applied by the electrical stimulation module; representing the neural response signal acquired by the signal fusion and enhancement unit; The rate of change of the target neural response signal over time; Weight parameters for static signal response; A weight parameter which is the dynamic signal change rate; , The time interval start point and the end point of the target stimulation signal and the nerve response signal.
In a preferred embodiment, a neural response optimized closed-loop model is built based on the current intensity, frequency, or combination of activated electrodes included in the stimulation data;
;
Wherein the method comprises the steps of The intensity of the current is indicated and,Representing the frequency of the stimulus signal,Representing the set of electrodes that are activated,Representing a time variable; is shown in A target stimulus signal generated under the action of (a);
;
Wherein the method comprises the steps of Is the attenuation coefficient of current propagation; representing the angle between the electrode and the target nerve; Is the first Distance of the individual electrodes from the target nerve; Is the first Amperage of the individual active electrodes; Is the first Local conductivity at the individual electrode locations; Is the first Phase offset of the individual electrode signals.
In a preferred embodiment, the tissue conductivity measuring unit calculates the complex impedance of the target region by means of two separate electrode pairs and an impedance measuring chip, one of the two separate electrode pairs being an injection electrode pair into which a constant alternating current is injected, the other electrode pair being a measuring electrode pair for measuring the voltage difference.
The invention has the technical effects and advantages that:
The feedback control unit adjusts the stimulation data according to the dynamic change of the nerve response signal to form a closed-loop optimization mechanism, thereby overcoming the problem of uneven stimulation caused by individual tissue difference of a patient;
the four-electrode method is combined with the impedance measurement chip to construct a conductivity distribution model of the target area in real time, calculate local non-uniform conductivity, dynamically adjust electrode combination and current intensity, effectively adapt to the current diffusion problem caused by the difference of fat layer or liquid distribution of patients, and improve the targeting of electrical stimulation.
Drawings
FIG. 1 is a diagram of a system hierarchy of the present invention.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Referring to fig. 1 of the specification, a thyroid laryngeal recurrent nerve simulation marking system according to an embodiment of the present invention includes a data input layer, a data processing layer, and a data output layer;
the data input layer is used for transmitting the stimulation data and the biological signals to the data processing layer;
The data processing layer is used for outputting analysis results to the data output layer;
the data output layer comprises a positioning prompt module and a display and interaction module, and is used for receiving the analysis result of the data processing layer and executing feedback;
The electric stimulation module comprises a multipolar electrode array, a current distribution unit and a tissue conductivity measurement unit, wherein the distributed current is applied to a target nerve, the multipolar electrode array comprises at least two groups of independent electrode pairs, each independent electrode in the electrode pairs is used for independently regulating and controlling the current intensity by connecting the current distribution unit, the current distribution unit distributes the current to different independent electrodes according to preset stimulation data and is used for regulating the stimulation intensity and the stimulation position, the tissue conductivity measurement unit calculates the complex impedance of a target area by two groups of independent electrode pairs and an impedance measurement chip, one group of the two groups of independent electrode pairs is an injection electrode pair, the injection electrode pair is injected with constant alternating current, the other group of the electrode pairs is a measurement electrode pair, the measurement electrode pairs are used for measuring voltage differences and are used for forming a four-electrode method, and the impedance measurement chip comprises but is not limited by AD5933;
The signal acquisition module comprises an electrophysiological sensor array, a signal fusion and enhancement unit and a feedback control unit, wherein the electrophysiological sensor type in the electrophysiological sensor array is selected and comprises, but not limited to BIOPAC-EL503, the electrophysiological sensor array is arranged around a stimulation area and is used for acquiring biological signals of nerve activity, 9 electrophysiological sensors can be selected as the array mode to form a 3*3 array arrangement mode, the signal fusion and enhancement unit is used for amplifying the nerve signals, eliminating noise interference and converting the signals into digital output, the feedback control unit is used for receiving the biological signals of target nerves provided by the signal acquisition module and the stimulation data of the current electrical stimulation module, calculating the deviation of the biological signal intensity and the expected effect through time sequence alignment and feature matching, and the feedback control unit adjusts the stimulation data according to the deviation, wherein the stimulation data comprises current intensity, frequency or activated electrode combination, generates dynamic optimization instructions and transmits the dynamic optimization instructions to the electrical stimulation module to complete the updating of the stimulation data.
The current distribution unit comprises a multichannel digital-to-analog converter DAC and a power amplifier, wherein the multichannel digital-to-analog converter DAC comprises but is not limited to a TI-DAC8734, and the power amplifier comprises but is not limited to an OPA541;
The signal fusion and enhancement unit comprises a differential amplifier, a filter and an analog-to-digital converter ADC, wherein the analog-to-digital converter ADC is used for converting biological signals into digital signals for data processing, the differential amplifier is used for eliminating noise by a filtering circuit and enhancing the signals, the filter is used for eliminating environmental interference, and the filter comprises a high-pass filter (50 Hz) and a low-pass filter (500 Hz).
The central control module comprises a microcontroller MCU, a data storage unit and a communication interface, wherein the communication interface comprises an I2C bus and a UART interface, the I2C bus is used for connecting with the data input layer module to transmit control instructions, and the UART interface is used for connecting with the data output layer to transmit analysis results;
In a further configuration scheme, the data storage unit of the central control module can store and read the patient stimulation data and the nerve state history record through an external record carrier, so that the actual use is facilitated, the external record carrier comprises an IC card or an NFC electronic tag, meanwhile, the positioning prompt module can also generate a relative unique digital mark in the system through a state indicator lamp, the digital mark is used for marking the target nerve position and state and is displayed on a screen or stored in the record carrier, the relative unique digital mark comprises a two-dimensional code or a serial number, the digital mark, the stimulation data and the analysis result are transmitted through a communication interface, and interaction with the external record carrier is supported.
The positioning prompt module comprises a vibration unit and a state indicator lamp, wherein the positioning prompt module prompts the position or condition of a target nerve in a visual or physical mode, the vibration unit comprises a vibration motor, the vibration unit prompts the risk of the area close to the nerve in a vibration frequency or vibration intensity mode, the state indicator lamp is used for displaying the state risk information of the nerve, for example, a bicolor red-green LED is used for displaying the state information of the nerve, the green color can represent safety and no risk, and the red color is used for providing high risk;
The display and interaction module is used for transmitting the running state of the system and the analysis result to a doctor for reading in a screen or audio mode.
The input end of the multi-electrode array is connected to the output end of the current distribution unit through a wire and used for receiving current and applying stimulation, the input end of the current distribution unit is connected to the output end of the micro-controller MCU through an I2C bus and used for receiving stimulation data instructions, the output end of the tissue conductivity measurement unit is connected to the input end of the micro-controller MCU through an I2C bus and used for transmitting complex impedance data, the input end of the tissue conductivity measurement unit is respectively connected to the output ends of the injection electrode pair and the measurement electrode pair through wires and used for receiving constant alternating current and voltage signals of a target area, and the output ends of the injection electrode pair and the measurement electrode pair are connected to the input end of the impedance measurement chip through wires and used for calculating the complex impedance data;
The system comprises an electrophysiological sensor array, a signal fusion and enhancement unit, a feedback control unit, an I2C bus and a microcontroller MCU, wherein the electrophysiological sensor array is connected with the input end of a differential amplifier of the signal fusion and enhancement unit through a wire and is used for collecting nerve activity signals of a target area;
The central control module is connected with the positioning prompt module through a UART interface and is used for transmitting the nerve position and risk state information; the central control module is connected with the display and interaction module through a UART interface and used for transmitting analysis results and system running states;
The power supply and protection module supplies power to the data input layer, the data processing layer and the data output layer through power lines, and is connected with the microcontroller MCU through an overcurrent protection circuit to realize power supply state monitoring and protection, in the construction of the overcurrent protection circuit, a shunt resistor with a low resistance value can be connected in series in the power lines for detecting current change of the circuit, voltage signals at two ends of the shunt resistor are amplified through an operational amplifier circuit and then transmitted to the ADC input end of the analog-to-digital converter, the microcontroller MCU reads and calculates the current value in real time, when the current value exceeds a set threshold value, the microcontroller MCU cuts off power supply output through controlling a MOSFET or a relay, so that overcurrent protection is realized, and meanwhile, the microcontroller MCU can report the power supply state to the system through a communication interface to realize real-time monitoring and protection functions.
Constructing a tissue conductivity distribution model based on the tissue conductivity measurement unit and the current distribution unit, which is expressed as:
;
Wherein the method comprises the steps of A conductivity distribution in three-dimensional space for the target region; Representing the constant alternating current injected by the pair of injection electrodes; representing the voltage difference recorded by the measurement electrode pair; As the geometric correction coefficient, Depending on the electrode structure and target area size; to measure the amount of change in the voltage difference across the electrode pair; Is the amount of change in distance between the electrode pairs; The gradient of the voltage difference along with the change of the inter-electrode distance is used for dynamically compensating the non-uniform conductivity, and the adaptability of the model to individual differences is improved by dynamically compensating the conductivity of tissue distribution;
the above is measured by a tissue conductivity measuring unit AndAnd calculatingThe current distribution unit is based on the calculationTo optimize the electrode activation pattern and amperage;
The neural response optimization closed loop model is constructed based on the feedback control unit and the signal fusion and enhancement unit and is expressed as follows:
;
Wherein the method comprises the steps of Is the deviation of the neural response signal from the target stimulus signal, for feedback control; representing a target stimulation signal applied by the electrical stimulation module; representing the neural response signal acquired by the signal fusion and enhancement unit; The change rate of the target neural response signal with time is calculated by the time characteristics of the acquired neural response signal; Weight parameters for static signal response; A weight parameter which is the dynamic signal change rate; Representing a time variable; , the method comprises the steps of acquiring a biological signal, wherein the biological signal comprises a nerve response signal, the nerve response signal is a response of a specific target nerve to stimulation in a model, the biological signal generally refers to all acquired signals comprising noise and non-target signals, and the desired effect described in the calculation of deviation of the biological signal intensity from the desired effect comprises the target stimulation signal;
The feedback control unit is used for receiving AndCalculation ofAdjusting the current intensity, frequency and electrode activation combination according to the deviation, providing amplified and noise reduced by differential amplifier and filter of signal fusion and enhancement unit;
Establishing a neural response optimization closed-loop model based on the current intensity, frequency, or activated electrode combination included in the stimulation data;
;
Wherein the method comprises the steps of The intensity of the current is indicated and,Representing the frequency of the stimulus signal,Representing the active electrode set, i.e. the electrode index involved in signal generation,Representing a time variable; is shown in A target stimulus signal generated under the action of (a);
;
Wherein the method comprises the steps of Is the attenuation coefficient of the current propagation,Representing current in biological tissueAn increased degree of attenuation; Indicating the angle between the electrode and the target nerve, i.e. the degree of matching between the electrode direction and the nerve direction, when Approaching zero, the current stimulation efficiency is relatively higher; Is the first The distance of the individual electrodes from the target nerve,Representing the square of the distance between the electrode and the target nerve; Is the first Amperage of the individual active electrodes; Is the first The local conductivity of the individual electrode locations,Obtaining by a tissue conductivity measurement unit; Is the first The phase offset of the individual electrode signals,For describing timing differences of multipole electrode outputs; An exponential decay factor representing the propagation of current through tissue, which is used to describe the current signal as a function of time Is a nonlinear decay of (a); As a directivity correction factor, when When the direction is optimal, the directivity correction factor is 1, whenThe direction is completely opposite, and the directivity correction factor is 0 and is used for quantitatively reflecting the influence of the matching degree of the current direction and the target nerve direction on the stimulation efficiency; Basic weights for describing the response of electrode signals to target nerves, which take into account electrode current intensity, conductivity, and electrode-to-nerve distance; Representing the periodic variation of the current signal, AndDetermining the dynamic characteristics of each electrode signal, in a multipolar electrode combination, an activated electrode setAllowing the plurality of electrodes to work cooperatively, the weight being determined by the above factors;
in the scheme, the system firstly applies multipolar current stimulation through an electric stimulation module in a data input layer, measures the conductivity distribution of a target area in real time by using a current distribution unit and a tissue conductivity measurement unit, measures injection current and voltage difference through a four-electrode method, builds a three-dimensional conductivity distribution model, dynamically compensates individual tissue difference, optimizes electrode activation mode and current intensity so as to ensure the accuracy of stimulation, simultaneously, the signal acquisition module acquires nerve biological signals of a target area through an electrophysiological sensor array, the signal fusion and enhancement unit transmits high-quality nerve response signals to a feedback control unit after amplification, filtering and analog-to-digital conversion processing, the feedback control unit and the electric stimulation module form a closed loop, dynamically adjusts the stimulation intensity, frequency and activated electrode combination by using the nerve response optimization closed loop model according to the time sequence deviation of the acquired nerve response signals and stimulation data, integrates input data by using a central control module in the data processing layer, analyzes the nerve position and state in real time, and can further display the real-time state by using the position information of the target area through the data output layer and the LED to enable the position and the vibration signal to be used for the system to display the real-time condition of the target area, and the system can further display the real-time condition of the system to be interacted with the vibration and the target area, and the system can be used for the real-time and the condition of the system to display and the condition of the system, a neural marking solution is provided.
The foregoing description of the preferred embodiments of the invention is not intended to limit the invention to the precise form disclosed, and any such modifications, equivalents, and alternatives falling within the spirit and principles of the invention are intended to be included within the scope of the invention.
Claims (8)
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| CN119970214B (en) * | 2025-04-17 | 2025-07-15 | 湖南金柏威医疗科技有限公司 | An endoscopic thyroid-specific nerve monitoring bipolar |
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| WO2018087601A1 (en) * | 2016-11-11 | 2018-05-17 | National University Of Ireland, Galway | Devices, systems, and methods for specializing, monitoring, and/or evaluating therapeutic nasal neuromodulation |
| US12515050B2 (en) * | 2022-02-04 | 2026-01-06 | Saluda Medical Pty Ltd | Measurement of neural responses to neurostimulation |
| CN116650832A (en) * | 2022-02-21 | 2023-08-29 | 杭州神络医疗科技有限公司 | Closed-loop management of neurostimulators |
| CN118824467A (en) * | 2024-06-21 | 2024-10-22 | 南方科技大学 | Electrical stimulation parameter optimization method and control instruction generation method |
| CN118634423B (en) * | 2024-08-16 | 2024-12-17 | 首都医科大学宣武医院 | TDCS transcranial direct current stimulation system |
| CN119280675B (en) * | 2024-12-12 | 2025-05-16 | 深圳中科华意科技有限公司 | Closed-loop multi-guide multi-mode time domain interference electric stimulation system and method |
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