Method and equipment for monitoring recurrent laryngeal nerves and supralaryngeal nerves during operation

Abstract

The invention belongs to the field of cricothyroid muscle, particularly relates to a method and equipment for monitoring recurrent laryngeal nerves and supralaryngeal nerves in an operation, and aims to solve the problems that in an existing monitoring mode, false alarms are extremely easy to generate, and an operator is misguided; in order to solve the problems that in the prior art, the oral cavity, the nasal cavity and the throat mucosa of a patient are easily damaged, and monitoring data are inaccurate, the following monitoring method and equipment are provided, and the equipment comprises a myoelectricity monitoring device, a stimulating electrode, a signal processing device and a signal analysis device; the myoelectricity monitoring and stimulating electrode is a pasting type concentric circle short needle electrode, the pasting short needle electrode comprises a needle body, a conductive terminal, an isolation sleeve, an elastic piece, a tail end circular ring and a pasting piece, and monitoring and stimulating are integrated. The device is not influenced by the position of the trachea cannula, has small influence on the operation of the endoscopic surgery, does not give an error alarm, further prevents the device from misleading an operator, does not damage the oral cavity, the nasal cavity and the throat mucosa of a patient, and improves the safety of the device.

Description

Technical Field

[0001] The present invention relates to the technical field of cricothyroid muscles, and in particular to a method and a device for intraoperative monitoring of the recurrent laryngeal nerve and the superior laryngeal nerve. Background Art

[0002] In surgeries such as esophageal cancer and thyroid cancer that require intraoperative cervical lymph node dissection, it is important to avoid damaging the nerves surrounding the lymph nodes, which may lead to poor prognosis for patients. The cricothyroid muscle is a superficial muscle of the biceps, originating from the thyroid cartilage and ending at the cricoid cartilage. When the cricothyroid muscle contracts, the thyroid cartilage is fixed and the cricoid cartilage is active. When one side of the cricothyroid muscle is paralyzed, the cricoid cartilage arch deflects toward the key side, and the posterior end of the glottis deflects toward the affected side. Studies have found that the median ratio of the amplitude induced by the cricothyroid muscle after stimulating the recurrent laryngeal nerve and the external branch of the superior laryngeal nerve is 8.5%, and the maximum is 62%. This also shows that the cricothyroid muscle is dually innervated by the recurrent laryngeal nerve and the superior laryngeal nerve through the human communication nerve. Therefore, when it is necessary to dissect the lymph nodes near the thyroid gland, the integrity of the superior laryngeal nerve and the recurrent laryngeal nerve can be judged by monitoring the cricothyroid muscle electromyography.

[0003] After searching, the invention with the announcement number CN117224802A relates to a neurological monitoring endotracheal tube, wherein an inflatable cuff is fixedly connected to the outer peripheral wall of one end of the endotracheal tube, the inflatable cuff is connected to the inflatable balloon through the hollow of the airway tube, a medical sleeve is sleeved on the outer peripheral wall of the endotracheal tube near the inflatable cuff, the medical sleeve is adapted to the glottic fissure, and the outer wall of the medical sleeve is provided with left and right marks for identifying the left and right positions of the endotracheal tube and a depth mark for determining the intubation depth, and the wire assembly arranged on the inner peripheral wall of the endotracheal tube is electrically connected to the electric guide wire assembly; on the one hand, by arranging the medical sleeve to adapt to the glottic fissure, the fit between the medical sleeve and the vocal cords is improved, and at the same time, the axial alignment of the endotracheal tube and the glottic fissure is facilitated; on the other hand, by arranging the left and right marks and the depth mark, the left and right, depth and axial positioning of the endotracheal tube are realized, the one-time arrival rate of the endotracheal tube is improved, and the damage to the patient caused by repeated adjustment of the position of the endotracheal tube is reduced.

[0004] After searching, the invention with announcement number CN115581521A relates to a nerve monitoring system suitable for thyroid tumor ablation and its use method, including a nerve stimulation needle, the nerve stimulation needle includes a conductive needle rod and an insulating needle handle, one end of the conductive needle rod is provided with a conductive needle tip, and the outer surface of the conductive needle rod is provided with an insulating layer; and a nerve monitor, including a host and a display screen, the host is connected to the nerve stimulation needle through a first wire for providing a stimulation signal, the host is connected to a recording electrode through a second wire for monitoring electromyographic signals, and the display screen is connected to the host for displaying an electromyogram; this system can be used in conjunction with an existing ablation system and an ultrasonic system, and can monitor in real time during ablation whether the recurrent laryngeal nerve or vagus nerve is damaged, so that during ablation, the doctor can promptly discover whether the recurrent laryngeal nerve or vagus nerve is damaged, thereby effectively preventing continuous nerve damage during ablation and achieving the purpose of protecting the recurrent laryngeal nerve and vagus nerve.

[0005] After searching, the utility model with application number CN201621344030.5 discloses a real-time monitor for the recurrent laryngeal nerve. The detector includes a main unit, an interface box and a junction box, and is characterized in that the interface box includes a positive electrode needle and a negative electrode needle, the junction box is electrically connected to a surgical instrument, the main unit is electrically connected to the junction box through the interface box, and the positive electrode needle and the negative electrode needle are connected to the interface box. The utility model can realize real-time monitoring under semi-anesthesia and will not damage the vocal cords while monitoring the nerves.

[0006] In the existing neurological monitoring endotracheal cannula, the metal guide wire exposed in the middle and lower part of the cannula forms an electrode loop and contacts the vocal cord muscle. When the myoelectric fibrillation occurs and myoelectric signals are generated, the metal guide wire transmits the myoelectric signals to the electromyographic device for monitoring. Similarly, in the current needle electrode monitoring method, the positive and negative electrodes of the needle electrode are inserted into the notch of the thyroid cartilage on both sides, and the vocal cord muscle on the thyroid cartilage is used to monitor the myoelectric signals.

[0007] Existing monitoring and protection methods include neurological monitoring intubation and surface electromyography monitoring. These two monitoring methods have the following problems: the exposed metal wire can easily contact tissues other than the vocal cords, resulting in a conductive bypass, which can easily cause false alarms and mislead operators; it can easily cause damage to the patient's oral, nasal and throat mucosa, resulting in symptoms such as mucosal congestion, edema, and bleeding; and surface electromyography monitoring is easily affected by external factors, such as interference from ECG signals, power frequency noise and peak amplitude, resulting in inaccurate monitoring data. Summary of the invention

[0008] The purpose of the present invention is to solve the problems existing in the monitoring methods of the prior art: the exposed metal wire is easy to contact the tissues other than the vocal cords, and produce a conductive bypass, which is very likely to produce false alarms and mislead the operator; it is easy to cause damage to the patient's oral, nasal and throat mucosa, resulting in symptoms such as mucosal congestion, edema, and bleeding; and surface electromyography monitoring is easily affected by external factors, such as electrocardiogram signals, power frequency noise and peak amplitude, resulting in inaccurate monitoring data. A method and device for intraoperative monitoring of the recurrent laryngeal nerve and superior laryngeal nerve are proposed.

[0009] In order to achieve the above object, the present invention adopts the following technical solutions:

[0010] An intraoperative recurrent laryngeal nerve and superior laryngeal nerve monitoring device, comprising an electromyographic monitor, a stimulation electrode, a signal processing device, and a signal analysis device;

[0011] The electromyography monitoring and stimulation electrode is a short-needle adhesive electrode, which includes a needle body, a conductive terminal, an isolation sleeve, a spring and an adhesive sheet, integrating monitoring and stimulation, wherein the needle body is wrapped in the adhesive sheet, and the other end of the needle body is connected to a signal processing device through a conductive terminal, and the signal processing device is connected to a signal analysis device.

[0012] In a possible design, the signal analysis device performs myoelectric digital signal processing and feature extraction to obtain muscle state analysis results, specifically including: time domain, amplitude, and conduction velocity.

[0013] In a possible design, the stimulation mode of the electromyography monitoring and stimulation electrodes is multi-pulse square wave stimulation.

[0014] In a possible design, the length range of the electromyography monitoring and stimulation electrodes is set to be 1.6-3.2 mm.

[0015] In a possible design, the parameters of the electromyography monitoring and stimulation electrodes are a pulse width of 0.10 to 0.30 ms, an interval of 2 ms, and a stimulation intensity of 300 to 1000 V.

[0016] In a possible design, the signal analysis device establishes a muscle force contraction curve; performs feature extraction on a nonlinear subsequence set of the electromyographic digital signal, and calculates the root mean square and average absolute value of the nonlinear subsequence of each electromyographic digital signal, thereby determining the degree of nerve damage.

[0017] In one possible design, the signal processing device is composed of an amplifier, a filter, an AD converter and a stimulator, the stimulator is electrically connected to the amplifier, the amplifier is electrically connected to the filter, and the filter is electrically connected to the AD converter.

[0018] A method for intraoperative monitoring of the recurrent laryngeal nerve and the superior laryngeal nerve, comprising the following steps:

[0019] S1. The subjects were in a supine position during the procedure, and the electrode was inserted from the level of the cricothyroid muscle, off the midline, with a needle insertion depth of 1.6-3.2 mm;

[0020] S2, the stimulation electrodes are connected to the electromyography monitoring and signal processing and analysis device; the device is set with a stimulation frequency of 1HZ, a stimulation pulse width of 0.2ms, and a scanning speed of 3ms / D;

[0021] S3. Stimulate the nerve with electric currents of different magnitudes and collect the amplitude of cricothyroid electromyographic signals.

[0022] In the present application, the patient is in the supine position during the operation, the cricothyroid muscle is obviously located and superficial, and the use of adhesive short needle electrodes can penetrate the muscle more quickly and accurately. At the same time, this type of electrode is short and not easy to pierce the muscle and damage other tissues. According to the anatomy of the cricothyroid muscle, "the whole muscle is thick on the top and thin on the bottom, wide on the top and narrow on the bottom. The width of the straight part measured in the plane of the lower edge of the thyroid cartilage is 10.1±1.8 (8.2~13.8) mm, and the thickness is 1.6±0.3 (1.2~2.1) mm; the width of the oblique part is 11.6±2.0 (8.3~14.0) mm, and the thickness is 1.4±0.3 (0.9~1.8) mm." Therefore, the length range of the electromyography monitoring and stimulation electrodes is set at 1.6-3.2 mm. At the same time, according to the electromyography monitoring and stimulation electrode stimulation mode and parameters, it can be set to: multi-pulse square wave stimulation, pulse width 0.10~0.30ms, interval 2ms, stimulation intensity 300~1000V.

[0023] The signal processing device is composed of an amplifier, a filter, an AD converter, and a stimulator. The signal processing device first releases multi-pulse square wave stimulation through the stimulator, and then amplifies the collected cricothyroid EMG signal through the analog signal amplification unit to avoid the influence of the EMG signal amplitude being too weak. The amplified surface EMG analog signal is filtered through a bandpass filter unit to select the passed signal. The filtered signal is then converted into a digital quantity through an A / D converter, and the digital quantity of the cricothyroid EMG signal is transmitted to the signal analysis device.

[0024] The signal analysis device processes the electromyographic digital signal and extracts its features to obtain the muscle state analysis results, including: time domain, amplitude, conduction velocity, etc.; establishes a muscle force contraction curve; extracts features from the nonlinear subsequence set of the electromyographic digital signal, calculates the root mean square and average absolute value of the nonlinear subsequence of each electromyographic digital signal, and thus determines the nerve damage;

[0025] Monitoring methods:

[0026] 1. The subjects were in a supine position during the operation, and the electrode was inserted from the level of the cricothyroid muscle, off the midline, with a needle insertion depth of 1.6-3.2 mm;

[0027] 2. The stimulation electrodes are connected to the electromyography monitoring and signal processing and analysis device; the device is set with a stimulation frequency of 1HZ, a stimulation pulse width of 0.2ms, and a scanning speed of 3ms / D;

[0028] 3. Stimulate the nerve with electric currents of different magnitudes and collect the amplitude of cricothyroid electromyographic signals.

[0029] Beneficial effects:

[0030] In the present invention, the use of cricothyroid electromyography to monitor the recurrent laryngeal nerve function and the superior laryngeal nerve function is safe and feasible, easy to install, has a strong electromyography signal, is not affected by the position of the endotracheal tube, has little effect on the laparoscopic surgery operation, and will not cause false alarms, thereby avoiding the device misleading the operator and causing no damage to the patient's oral, nasal and pharyngeal mucosa, thereby improving the safety of the device. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 A schematic diagram of the three-dimensional structure of a device for monitoring the recurrent laryngeal nerve and superior laryngeal nerve during surgery proposed by the present invention;

[0032] Figure 2 A schematic diagram of the explosion structure of a device for monitoring the recurrent laryngeal nerve and superior laryngeal nerve during surgery proposed by the present invention;

[0033] Figure 3 is a line graph of the experimental results of stimulating the superior laryngeal nerve in the present invention;

[0034] Figure 4 A block diagram of the experimental results of stimulating the superior laryngeal nerve in the present invention;

[0035] Figure 5 is a line graph of the experimental results of stimulating the recurrent laryngeal nerve in the present invention;

[0036] Figure 6 It is a block diagram of the experimental results of stimulating the recurrent laryngeal nerve in the present invention.

[0037] In the figure: 1. needle body; 2. adhesive sheet; 3. conductive terminal. DETAILED DESCRIPTION

[0038] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments.

[0039] Example 1

[0040] Reference Figure 1-6 , a device for intraoperative monitoring of the recurrent laryngeal nerve and superior laryngeal nerve, which is used in the field of cricothyroid muscle, including: electromyographic monitoring, stimulation electrodes, signal processing device and signal analysis device;

[0041] The electromyographic monitoring and stimulation electrodes are short-needle adhesive electrodes, which include a needle body 1, a conductive terminal 3, an isolation sleeve, a spring and an adhesive sheet 2, and are integrated with monitoring and stimulation, wherein the needle body 1 is wrapped in the adhesive sheet 2, and the other end of the needle body 1 is connected to a signal processing device through a conductive terminal 3, and the signal processing device is connected to a signal analysis device. The length range of the electromyographic monitoring and stimulation electrodes is set to 1.6 mm, and the parameters of the electromyographic monitoring and stimulation electrodes are a pulse width of 0.10 ms, an interval of 2 ms, and a stimulation intensity of 300 V;

[0042] The signal processing device is composed of an amplifier, a filter, an AD converter and a stimulator, wherein the stimulator is electrically connected to the amplifier, the amplifier is electrically connected to the filter, and the filter is electrically connected to the AD converter;

[0043] The signal analysis device processes the electromyographic digital signal and extracts its features to obtain the muscle state analysis results, including: time domain, amplitude, conduction velocity, and the signal analysis device establishes a muscle force contraction curve; extracts features from the nonlinear subsequence set of the electromyographic digital signal, calculates the root mean square and average absolute value of the nonlinear subsequence of each electromyographic digital signal, and thus determines the nerve damage;

[0044] The stimulation mode of the electromyography monitoring and stimulation electrodes is multi-pulse square wave stimulation.

[0045] A method for intraoperative monitoring of the recurrent laryngeal nerve and the superior laryngeal nerve, comprising the following steps:

[0046] S1. The subjects were in a supine position during the procedure, and the electrode was inserted from the level of the cricothyroid muscle, off the midline, with a needle insertion depth of 1.6 mm;

[0047] S2, the stimulation electrodes are connected to the electromyography monitoring and signal processing and analysis device; the device is set with a stimulation frequency of 1HZ, a stimulation pulse width of 0.2ms, and a scanning speed of 3ms / D;

[0048] S3. Stimulate the nerve with electric currents of different magnitudes and collect the amplitude of cricothyroid electromyographic signals.

[0049] Example 2

[0050] Reference Figure 1-6 , a device for intraoperative monitoring of the recurrent laryngeal nerve and superior laryngeal nerve, which is used in the field of cricothyroid muscle, including: electromyographic monitoring, stimulation electrodes, signal processing device and signal analysis device;

[0051] The electromyographic monitoring and stimulation electrode is a short-needle adhesive electrode, which includes a needle body 1, a conductive terminal 3, an isolation sleeve, a spring and an adhesive sheet 2, and is integrated with monitoring and stimulation, wherein the needle body 1 is wrapped in the adhesive sheet 2, and the other end of the needle body 1 is connected to the signal processing device through the conductive terminal 3. The length range of the electromyographic monitoring and stimulation electrode is set to 3.0 mm, and the parameters of the electromyographic monitoring and stimulation electrode are a pulse width of 0.30 ms, an interval of 2 ms, and a stimulation intensity of 1000 V;

[0052] The signal processing device consists of an amplifier, a filter, an AD converter, and a stimulator;

[0053] The stimulator is electrically connected to the amplifier, the amplifier is electrically connected to the filter, and the filter is electrically connected to the AD converter;

[0054] The signal analysis device processes the electromyographic digital signal and extracts its features to obtain the muscle state analysis results, including: time domain, amplitude, conduction velocity, and the signal analysis device establishes a muscle force contraction curve; extracts features from the nonlinear subsequence set of the electromyographic digital signal, calculates the root mean square and average absolute value of the nonlinear subsequence of each electromyographic digital signal, and thus determines the nerve damage;

[0055] The stimulation mode of the electromyography monitoring and stimulation electrodes is multi-pulse square wave stimulation.

[0056] Example 3 (Verifying the feasibility of monitoring the integrity of the recurrent laryngeal and superior laryngeal nerves by monitoring the cricothyroid muscle)

[0057] The recurrent laryngeal nerve and superior laryngeal nerve were stimulated by different currents, and the electromyographic signal data generated by the cricothyroid muscle was monitored.

[0058] Steps:

[0059] 1. The subjects were in supine position during the operation. The electrode was inserted at the level of the cricothyroid membrane, deviated from the midline and slightly outward and upward. The needle insertion depth was 1.8 mm.

[0060] 2. The electromyography monitoring and stimulation electrodes are connected to the signal processing and analysis device; the device is set with a stimulation frequency of 1 Hz, a stimulation pulse width of 0.2 ms, and a scanning speed of 3 ms / D.

[0061] 3. Stimulate the nerve with electric currents of different magnitudes and collect the amplitude of cricothyroid electromyographic signals.

[0062] Experimental data: Figure 3-Figure 6 As shown;

[0063] The above experimental results verify that the use of cricothyroid electromyography to evaluate the function of the recurrent laryngeal nerve is safe and feasible, easy to install, has a strong electromyographic signal, is not affected by the position of the endotracheal tube, and has little impact on laparoscopic surgical operations.

[0064] However, as is well known to those skilled in the art, the working principles and wiring methods of amplifiers, filters, AD converters, stimulators are commonplace, and are conventional means or common knowledge, and will not be elaborated here. Those skilled in the art may make any optional selections according to their needs or convenience.

[0065] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A device for monitoring the recurrent laryngeal nerve and superior laryngeal nerve during surgery, characterized in that: include: EMG monitoring, stimulation electrodes, signal processing devices and signal analysis devices; The electromyography monitoring and stimulation electrode is a short-needle adhesive electrode, which comprises a needle body (1), a conductive terminal (3), an isolation sleeve, a spring sheet and an adhesive sheet (2), and integrates monitoring and stimulation, wherein the needle body (1) is wrapped in the adhesive sheet (2), and the other end of the needle body (1) is connected to a signal processing device via a conductive terminal (3), and the signal processing device is connected to a signal analysis device.

2. The device for monitoring the recurrent laryngeal nerve and superior laryngeal nerve during surgery according to claim 1, characterized in that: The signal analysis device performs myoelectric digital signal processing and feature extraction to obtain muscle state analysis results, specifically including: time domain, amplitude, and conduction velocity.

3. The device for monitoring the recurrent laryngeal nerve and superior laryngeal nerve during surgery according to claim 1, characterized in that: The stimulation mode of the electromyography monitoring and stimulation electrodes is multi-pulse square wave stimulation.

4. The device for monitoring the recurrent laryngeal nerve and superior laryngeal nerve during surgery according to claim 1, characterized in that: The length range of the electromyography monitoring and stimulation electrodes is set at 1.6-3.2 mm.

5. The device for monitoring the recurrent laryngeal nerve and superior laryngeal nerve during surgery according to claim 1, characterized in that: The parameters of the electromyography monitoring and stimulation electrodes are pulse width 0.10-0.30 ms, interval 2 ms, and stimulation intensity 300-1000V.

6. The device for monitoring the recurrent laryngeal nerve and superior laryngeal nerve during surgery according to claim 1, characterized in that: The signal analysis device establishes a muscle force contraction curve; performs feature extraction on a nonlinear subsequence set of the electromyographic digital signal, and calculates the root mean square and average absolute value of each nonlinear subsequence of the electromyographic digital signal, thereby determining the nerve damage.

7. The device for monitoring the recurrent laryngeal nerve and superior laryngeal nerve during surgery according to claim 1, characterized in that: The signal processing device is composed of an amplifier, a filter, an AD converter and a stimulator. The stimulator is electrically connected to the amplifier, the amplifier is electrically connected to the filter, and the filter is electrically connected to the AD converter.

8. A method for intraoperative recurrent laryngeal nerve and superior laryngeal nerve monitoring equipment according to any one of claims 1 to 7, characterized in that: The specific steps include: S1. The subjects were in a supine position during the operation. The electrode was inserted from the level of the cricothyroid muscle, off the midline, to a depth of 1.6-3.2 mm. S2, the stimulation electrodes are connected to the electromyography monitoring and signal processing and analysis device; the device is set with a stimulation frequency of 1HZ, a stimulation pulse width of 0.2ms, and a scanning speed of 3ms / D; S3. Stimulate the nerve with electric currents of different magnitudes and collect the amplitude of cricothyroid electromyographic signals.

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