CN215900726U

CN215900726U - Sacculus device is used in oppression based on two feedbacks of bioelectricity signal and pressure

Info

Publication number: CN215900726U
Application number: CN202120139619.6U
Authority: CN
Inventors: 周乐; 闫先侠
Original assignee: Second Affiliated Hospital School of Medicine of Xian Jiaotong University
Current assignee: Second Affiliated Hospital School of Medicine of Xian Jiaotong University
Priority date: 2021-01-19
Filing date: 2021-01-19
Publication date: 2022-02-25
Anticipated expiration: 2031-01-19

Abstract

The utility model discloses a compression balloon device based on bioelectricity signal and pressure double feedback, wherein a stimulating electrode is arranged at the head end of a balloon, a stimulating electrode lead is led out through a guide rod and is connected to an external interface of the stimulating electrode to be connected with an electric stimulation output end of a myoelectricity monitoring device, an electromechanical signal receiving end is connected to masticatory muscles of a patient through a needle electrode to monitor myoelectricity change of the masticatory muscles, and two Ruhr connectors at the tail end of the balloon are respectively connected with an automatic injection pump and a pressure monitoring device. The utility model realizes the real-time monitoring of the function state of the trigeminal nerve and the working pressure of the saccule in the trigeminal nerve saccule compression operation and the automatic completion of the injection of the contrast agent. Provides safer, more direct and objective evaluation indexes for the operation, and ensures the controllable and automatic completion of the operation and the homogenization of the operation effect.

Description

Sacculus device is used in oppression based on two feedbacks of bioelectricity signal and pressure

Technical Field

The utility model is applied to the fields of saccule for percutaneous puncture trigeminal nerve micro-saccule compression, which is called saccule compression hereinafter and intelligent control equipment based on the saccule technology. In particular to a balloon device for compression based on bioelectricity signal and pressure double feedback.

Background

Percutaneous aspiration micro-balloon compression is currently an important surgical technique for treating trigeminal nerves. The technology is to press trigeminal nerve semilunar ganglion after the saccule is expanded in the Mycoplasma, and the pain sense conduction function of the saccule is damaged to achieve the purpose of pain sense blocking. When the balloon mechanically presses the trigeminal nerve fibers to destroy pain nerve fibers, the trigeminal nerve fibers and the motor nerve fibers are damaged simultaneously. It is currently believed that the pain nerve fibers are more sensitive to pressure than the tactile and motor nerve fibers. Therefore, patients are willing to undergo pain treatment after surgery, although symptoms such as paresthesia and masticatory muscle weakness may occur after the surgery. Ideally, the degree of surgical compression is the best choice for achieving the desired balance of pain nerve fibers and damage to other nerve fibers. That is, it is most desirable to have good control of pain while retaining other nerve fiber functions.

However, the current index for determining the operation process by the operator is mainly based on two points of the ideal balloon shape formed in the operation and the compression time of the balloon on the nerve, and more objective indexes are lacked. In actual work, the ideal balloon shape is the shape of the balloon in the Mylar sac, which indicates that the balloon is pressed at a proper position. The time of compression is completely dependent on the experience of the operator. Because the anatomical structure of the mylar sac may vary from patient to patient, the shape of the balloon may vary from patient to patient during surgery. The different doctors understand the operation, the length of the balloon compression time is different. The pain relieving degree, the facial numbness and the myasthenia of masticatory muscles of postoperative patients are different, and the patients cannot accurately control the operation, which is the biggest deficiency of the operation at present. In addition, the two indexes have certain experience factors, so that the operation is very dependent on the experience of an operator, and the precise operation and the homogenization popularization of the operation are not facilitated.

Factors determining the degree of injury of a nerve after compression are important indexes of compression strength, in addition to the compression position and the compression time. Nerve damage is necessarily more severe at the same site, at the same time, with greater pressure. Thus, monitoring of the intraoperative increase balloon pressure makes the procedure somewhat more objective and controllable. This was also confirmed by our earlier work. However, the same pressure, with different degrees of nerve damage, may be present due to anatomical variation or differences in the "pear" criteria. In addition, repeated filling of the balloon and catheter position adjustment are often required during surgery to achieve the desired balloon shape. When the saccule is filled repeatedly, the crushing injury of the saccule to the nerve is difficult to be calculated objectively by the pressure and the compression time. Therefore, monitoring of the operating pressure of the balloon alone during the operation cannot directly determine the condition of the nerve conduction block during the operation.

The essence of nerve fibers to accomplish pain sensation, touch sensation and motor function signal conduction is the conduction of electrical signals in nerve fibers. After the nerve fibers are compressed and damaged in the trigeminal balloon compression operation, the amplitude, latency period, speed and the like of action potentials conducted by the nerve fibers can be correspondingly changed. That is, after additional stimulation is administered upstream of the site of nerve fiber damage, there is a corresponding change in the neural signals detected downstream of the site of nerve fiber damage. This change in signal should be the most objective indicator for assessing neurological function. If the change of nerve conduction function can be monitored and obtained during the operation, the change is the most direct and objective intraoperative judgment index of the operation. In general anesthesia, the pain sensation of the patient is inhibited by the drug and is difficult to monitor intraoperatively, while the motor fibers are less affected by anesthesia. Since the trigeminal nerve is a mixed nerve, the motor fibers and pain fibers cannot be physically distinguished from each other by balloon compression. Therefore, trigeminal motor fibers can be used as an ideal intraoperative monitor to accurately represent the degree of change in conduction block after nerve compression.

The therapeutic target of the trigeminal nerve micro-balloon compression is the trigeminal ganglion. The semilunar junction of the trigeminal nerve is located in the mylar of the middle cranial fossa, especially deeply. By adopting a method of percutaneous puncture without craniotomy, the stimulating electrodes of the currently applied nerve electrophysiology monitoring equipment in clinic cannot smoothly reach the trigeminal nerve semilunar ganglion. In addition, even if the stimulation electrode is designed to reach the trigeminal ganglion through the percutaneous puncture of the foramen ovale, the passage of the balloon to reach the half-moon joint of the trigeminal ganglion through the percutaneous puncture of the foramen ovale is affected, and the stimulation electrode is difficult to accurately place at the upstream of the nerve damaged part. The most ideal situation is that the stimulating electrode is integrated at the head end of the balloon catheter for treatment, which not only can ensure the consistency of the tested nerve and the compression nerve, but also can not influence the operation at all. Electrical stimulation of the trigeminal nerve induces contraction of the innervating masticatory muscles, which in turn leads to a biting action. Therefore, the oral contents must be protected to avoid accidental injury when stimulating the trigeminal nerve during the operation. In fact, we have not seen any literature reports and related surgical instruments for monitoring neurophysiological functions in trigeminal balloon compression.

A second disadvantage of balloon compression is that it is temporarily not possible to automate the bolus injection of contrast media to achieve zero X-ray exposure for the operator. In the balloon compression, the insertion of the catheter or the filling of the balloon needs to be repeatedly confirmed under X-ray fluoroscopy. During surgery, both the patient and the operator have a lot of X-ray exposure. Because the operation is too dependent on the experience of operators, all automatic injection devices on the market at present cannot be applied to trigeminal nerve balloon compression operation. The reason for this is mainly due to the large anatomical variation of the volume of the bursa of fabricius. Our experience shows that the contrast dose required to fill the balloon during surgery varies from 0.4ml to 1.1ml, making it difficult to preset the bolus volume. Secondly, due to the lack of objective judgment standards, no feedback relation can be established between the bolus injection dosage and the compression degree, and the feedback type automatic control is difficult to realize. If the nerve damage degree can be quantified in real time by monitoring the changes of the pressure and trigeminal nerve movement evoked potential, the mapping relation between the bolus volume and the pressure and the evoked potential change degree (nerve conduction block) can be established, and the feedback type automatic bolus injection of the contrast agent is realized.

Disclosure of Invention

The utility model aims to overcome the defects in the prior art and provides a compression balloon device based on bioelectricity signal and pressure double feedback. The utility model can objectively know the nerve function status by monitoring the electrophysiological function of the trigeminal nerve in real time in the operation; meanwhile, the intelligent injection and release of the contrast agent are realized by establishing a mapping relation between the injection and release of the contrast agent, the bioelectric signal of the trigeminal nerve and the pressure in the balloon. The device enriches the objective judgment standard of treatment in the trigeminal neuralgia balloon compression operation, and enables the operation to be more accurate and standardized. Also thoroughly solves the problems that the prior trigeminal balloon compression operation seriously depends on the personal experience of the operator and can not be separated from X-ray operation, and the like, and ensures that the operation is safer and more controllable.

In order to achieve the purpose, the utility model adopts the following technical scheme:

the utility model provides a sacculus device is used in oppression based on two feedbacks of biological electricity signal and pressure, includes the sacculus, stimulation electrode, and the head end of sacculus is provided with stimulation electrode, and stimulation electrode wire is drawn through the guide arm, is connected to the electrical stimulation output of stimulation electrode external interface connection flesh electricity monitoring devices, and electromechanical signal receiving terminal passes through needle electrode and connects in patient's masticatory muscle, monitors masticatory muscle flesh electricity and changes.

Two Ruhr connectors at the tail end of the balloon are respectively connected with the automatic injector and the pressure monitoring equipment.

The control system is connected with the pressure monitoring equipment and the electrophysiological monitoring equipment, and the other end of the control system is connected with the automatic injection pump.

The control system comprises a pressure control system and an electromyographic physiological monitoring control system.

One end of the pressure control system is connected with the pressure monitor and used for receiving the real-time monitoring of the pressure in the saccule, the other end of the pressure control system is connected with the automatic injection pump, and when the pressure in the monitored saccule continuously rises and is smaller than the set threshold pressure after the injection pump works, the pressure monitoring system does not interfere the slow pushing work of the automatic injection pump; when the monitored pressure is smaller than the set pressure but does not rise or even fall along with the progressive injection of the injection pump, the pressure monitoring system sends an instruction to the automatic injection pump to stop the injection work; when the monitored pressure reaches the set threshold pressure, the pressure monitoring system sends an instruction to the automatic injection pump to stop the injection pump from continuing to inject.

The myoelectricity physiological detection system has the input end connected to the myoelectricity monitoring device, receives masticatory muscle myoelectricity signals, has the output end connected to the automatic injection pump, compares the masticatory muscle myoelectricity signals with preset myoelectricity threshold signals after receiving the masticatory muscle myoelectricity signals, makes a judgment, does not interfere the injection work of the automatic injection pump if the monitoring value of the myoelectricity signals does not reach the set threshold value, and sends an instruction to the automatic injection pump if the monitoring value of the myoelectricity signals reaches or exceeds the set threshold value, releases the contrast medium injected into the balloon, and terminates the operation.

The stimulating electrode can adopt a metal ball head at the most end of the balloon catheter, and also can adopt ductile flexible electrode materials integrated on the balloon wall.

The manual termination device is connected to the automatic syringe pump.

The multifunctional oral cavity protector is made of polyvinyl chloride. The multifunctional oral cavity protector comprises a bite block, a tooth baffle and a tracheal catheter fixing guide groove part.

The balloon device for automatic trigeminal nerve compression based on bioelectricity signal and pressure double feedback is characterized in that a stimulating electrode is integrated at the head end of a balloon catheter, and a pressure monitoring opening is designed at the tail end of the balloon catheter on the side of an injection port. The stimulating electrode is integrated at the most head end of the balloon catheter and can also be used as intraoperative ray marking metal; in addition, the stimulation electrode is also integrated on the outer wall of the balloon near the head end by adopting a malleable flexible electrode material.

The stimulating electrode is led out along the catheter through a lead. The guide wires are integrated on the outer wall of the catheter in the leading-out process, and are led out from the catheter close to the tail end of the catheter in the process of ensuring the space distance of the operation. The lead-out wires form a stimulation electrode socket.

The reactive automatic balloon filling device based on myoelectric evoked potential and pressure change measured in the operation consists of: a pressure monitoring device capable of monitoring pressure; an electrophysiological device capable of simultaneously completing electrical nerve stimulation and monitoring myoelectric response; the computer system can analyze the measured pressure and the electromyographic signals in real time and send the commands of pushing, stopping and releasing the pressure to the injection pump according to the variation values of the pressure and the electromyographic signals; and a syringe pump 4 portion operable under computer control. The four parts form a dual feedback system including pressure feedback and electrophysiological feedback under the control of the computer system. The pressure feedback system receives a balloon working pressure signal monitored by the pressure sensor, and determines whether the injection pump for injecting the contrast medium into the balloon continuously injects the contrast medium or stops injecting the contrast medium according to the pressure; the electrophysiological feedback system receives the electromyographic signal and determines the termination point of the balloon compression according to the change of the electromyographic signal (the reduction of the amplitude and the prolongation of the latency).

The X-ray external monitoring and manual termination device consists of a monitor and a manual termination pressure relief device. The monitor can display X-ray fluoroscopy result, pressure and myoelectricity monitoring result, heart rate, blood pressure, blood oxygen saturation and other monitoring results in the display, and the display is set near the operation room and isolated from the X-ray. The manual pressure release stopping device is arranged beside the monitor, and can send an instruction to the injection pump through the computer system at any time to stop injecting the contrast medium, release the contrast medium injected into the balloon, release the pressure in the balloon and stop the operation.

The multifunctional oral cavity protector is made of polyvinyl chloride. Trigeminal nerve receives external electrical stimulation to induce contraction of the innervated masticatory muscle. The biting action caused by the contraction of the chewing muscles may damage the oral contents. Occlusion of teeth under anesthesia may damage oral contents such as tracheal tubes, tongue, etc. The multifunctional oral cavity protector is independently applied between upper and lower teeth in the mouth of a patient, and a trachea cannula channel is reserved, so that a trachea cannula can pass through and be fixed conveniently. So as to prevent the chewing muscle from contracting to accidentally injure the tissue in the oral cavity or the tracheal catheter when electrically stimulating the trigeminal nerve in the operation and simultaneously fix the tracheal catheter in the operation.

The utility model realizes the real-time monitoring of the function state of the trigeminal nerve and the working pressure of the saccule in the trigeminal nerve saccule compression operation and the automatic completion of the injection of the contrast agent. Provides safer, more direct and objective evaluation indexes for the operation, and ensures the controllable and automatic completion of the operation and the homogenization of the operation effect.

Drawings

Fig. 1 is a working principle diagram of the present invention.

Fig. 2 is a schematic structural diagram of the present invention.

FIG. 3-A is a perspective view of a multi-functional mouth protector

FIG. 3-B is a plan view of the bite block from the direction of arrow B in the perspective view of the multi-functional mouth protector of FIG. 3-A;

FIG. 3-C is a schematic view of section C in perspective of the multi-functional mouth protector of FIG. 3-A;

FIG. 3-D is a plan view of the bite block in the direction of arrow D in the perspective view of the multi-functional mouth protector of FIG. 3-A;

in the figure, 1-stimulating electrode, a sacculus head end is fixed on a catheter, 2-sacculus, 3-is integrated on the wall of the catheter, a lead connected with the stimulating electrode, 4-sacculus catheter, the side wall of the balloon end of the catheter is provided with an opening towards the inside of the sacculus, liquid is allowed to enter and exit from the catheter into and out of the sacculus, 5-metal fixing device, the tail end of the sacculus is fixed on the sacculus catheter, 6-stimulating electrode external connector, 7-three-way structure, 8-luer, 9-luer, 10-dental pad of the multifunctional oral protector, 11-baffle of the multifunctional oral protector, 12-trachea cannula guide groove of the multifunctional oral protector

Detailed Description

The present invention is further illustrated by the following examples and figures, including but not limited to the following examples. All equivalent changes made on the basis of the technical scheme of the application fall into the protection scope of the utility model.

As shown in fig. 1 to 3, this embodiment provides an automatic trigeminal compression balloon device based on bioelectricity signal and pressure dual feedback, which includes a balloon catheter integrated with a microelectrode, an external electrical stimulation signal generator, a myoelectricity monitoring system, a pressure monitoring system, an automatic contrast agent injection pump, an automatic control system, a compression time monitoring and early warning, a multifunctional oral cavity protector, an external ray monitoring and manual control system.

The novel balloon device which is integrated with the stimulating electrode at the head end of the balloon and can be externally connected with a pressure monitoring instrument can be realized in the following mode. The metal device 1 with the head end fixed with the head end of the sacculus conduit at the head end is used as a stimulating electrode, and the tail end (with a luer connector end) of the sacculus conduit is provided with a three-way device, so that the requirements of contrast agent injection and pressure monitoring can be met simultaneously. The contact of the electric stimulation microelectrode is positioned at the head end of the saccule (closer to the neural brain stem end after being implanted into the Mycobasal sac). This ensures that the stimulation site is upstream of the nerve fiber treatment target and effector. The stimulation electrode passes through the therapeutic target and then conducts to the effector (masticatory muscles). The microelectrode is converted into a lead extraction through a lead which extends along the wall of the balloon catheter to a position which is beyond the shortest distance required by the balloon catheter for treatment (the distance from the top end of the balloon to the outer opening of the puncture guide needle exposed out of the catheter during the balloon treatment, generally about 15-17 cm). The stimulation electrode lead interface can be externally connected with an electrical stimulation generator.

An external electrical stimulation signal generator (which can be integrated with an electromyographic signal monitoring system). The electrical stimulation signals may be activated and deactivated after receiving the command indication. The electrical stimulation signal sent out stimulates the trigeminal motor fiber through the stimulating microelectrode integrated at the head end of the saccule. The external electrical stimulation signal generator receives the signal instruction of the control system to work.

Myoelectric monitoring systems (which may be integrated with electrical stimulation signal generators). When the stimulating electrode at the head end of the saccule sends out an electrical stimulation signal, the trigeminal motor fiber transmits the stimulation signal to the ipsilateral masticatory muscle. In this case, an induced myoelectric signal can be recorded by the recording electrode of the masticatory muscle on the same side. The induced myoelectric signal recorded when the balloon catheter is in place is an initial basic myoelectric signal, and the signal recorded by pressing nerves after the balloon is full is a signal after treatment. The electromechanical monitoring system transmits the measured data to the control system.

A pressure monitoring system. When the injection pump starts to work, the pressure monitoring system can monitor the pressure change in the saccule in real time and transmit the measured data to the control system. (in combination with our past work experience, the pressure monitoring range can be set to 0-300kpa)

The automatic contrast agent injection pump is controlled by an automatic control system and can start, inject the contrast agent at a constant speed and stop injecting the contrast agent according to instructions. The contrast agent which is already pushed into the balloon can be pumped back and emptied according to the instructions of an automatic control system and a manual control system. When the injection pump works continuously, the dosage and the speed of the injected contrast medium are fed back to the automatic control system, and the injection pump can work under the instruction of the automatic control system and the manual control system.

An automatic control system. The automatic control system is positioned in the treatment room, is connected with each instrument in the treatment room through a connecting wire and is connected with the control system outside the treatment room in a wireless or wired communication mode. The automatic control system is divided into the following subsystems:

a pressure control system. After the injection pump starts to work, the pressure monitoring system starts to work immediately and receives a pressure signal of the pressure monitoring system. The pressure control system can analyze the resulting pressure signal and feed back on the syringe pump. The doctor can set the upper limit value of the pressure required in the operation in advance according to the specific situation of the patient. There are mainly the following three feedback control modes. In the first mode: when the pressure in the saccule does not reach the set upper pressure limit, and simultaneously, the pressure gradually rises along with the injection of the contrast medium, the pressure control system can not send a termination instruction to the injection pump, and the injection pump injects the contrast medium at a constant speed according to a set speed. In the second mode: when the pressure reaches or is higher than the set upper pressure limit value, the pressure control system automatically sends an instruction to the injection pump, and the injection pump stops injecting the contrast medium. The third mode: when the pressure does not reach the set highest pressure and is on-line, but the monitored pressure does not rise or even fall any more along with the injection of the contrast medium, which indicates that the balloon is damaged or other accidents happen, the pressure control system automatically sends an instruction to the injection pump, and the injection pump stops injecting the contrast medium.

An electrophysiological monitoring control system. When the injection pump starts to work, the automatic control system can send a working instruction to the stimulating electrode. At this time, the electromyographic monitoring system starts to continuously receive the electromyographic signals of the respective innervated muscles. The electrophysiological signal measured by the electromyographic monitoring system before the operation of the injection pump is the basic electromyographic signal, and the measured electromyographic signal after the operation of the injection pump is the electromyographic signal after treatment. The electrophysiological monitoring control system can automatically analyze the difference between the data such as the wave amplitude, the latency period and the like between the treated electromyographic signal and the basic electromyographic signal. When the difference reaches the preset difference, the electrophysiological monitoring control system automatically sends an instruction to the injection pump, and the injection pump pumps back the contrast agent according to the injected contrast agent amount to finish the treatment.

And monitoring and early warning the compression time. When the ideal balloon shape is obtained during the operation, the calculation of the balloon compression time is manually started, and the compression time is displayed on a monitoring screen. At this time, the operator can monitor the operation progress according to the past experience. If the operator judges that the continuous treatment is more beneficial according to the shape of the saccule and the compression time, or the operator finds any abnormality in the operation process, the operator can stop the operation through the manual control system at any time.

A multifunctional oral cavity protector. The device can effectively avoid the injury of oral contents caused by the occlusion action caused by the electrical stimulation of the trigeminal nerve. The bite block is designed in a semi-arc shape, and can be placed between upper and lower teeth in the oral cavity during operation. The semi-arc guide groove can be used for the passing and fixing of the tracheal catheter.

The multifunctional oral cavity protector has the functions of simultaneously exposing a puncture point, fixing a tracheal cannula catheter and protecting oral cavity contents from bite injury in the following modes. The tracheal catheter guide groove of the fixator is eccentrically designed and is positioned on one side of the fixator. The arc design of the bite block and the baffle is suitable for the arrangement shape of teeth in the oral cavity. During operation, the tracheal catheter is placed in the oral lip and on the opposite side of the operation puncture point, so that the operation puncture point is exposed. During operation, the fixator is placed in the oral cavity, wherein the dental pad 10 is placed between the upper and lower teeth, so that the oral cavity contents are prevented from being directly bitten by the teeth during occlusion; when the upper and lower teeth are engaged on the bite block 10, the baffle 11 will be located at the outer side of the upper and lower teeth to prevent the fixture from slipping out of the oral cavity; after the surgical intubation anesthesia, the tracheal tube exits the lumen through the guide channel 12. In this case, the catheter may be fixed to the skin around the side of the mouth after the catheter is fixed to the guide groove with an adhesive tape. After the trigeminal nerve is electrically stimulated, the contraction of the masticatory muscles is induced to further promote the occlusion of teeth. In addition, the needle insertion point of percutaneous puncture trigeminal micro-balloon compression operation is 2-3 cm outside the affected side corner of mouth, and the puncture point is often covered by a common trachea cannula fixing device, so that the percutaneous puncture trigeminal micro-balloon compression operation is not suitable for the operation. The multifunctional oral cavity protector is a device which can simultaneously meet the requirements of exposing a puncture point, fixing a tracheal intubation catheter and protecting oral cavity contents from bite injury.

Following the above technical solution, as shown in fig. 3 (wherein a is a whole perspective view, B is a plan view from B, C is a schematic view of a section C in a, and D is a plan view from D in a), the present embodiment provides a multifunctional oral protector device capable of simultaneously satisfying the requirements of exposing a puncture point, satisfying the requirements of endotracheal intubation tube catheter fixation, and protecting oral cavity contents from bite injury, including a bite block, a tooth guard, and an endotracheal tube fixation guide groove portion.

Off-line monitoring and manual control systems.

The external ray monitoring system comprises an X-ray image monitoring system (which can display the imaging, pressure and electromyogram signal values of a C-shaped arm, a digital subtraction machine and other equipment during the operation). The operator can know the change of parameters such as the shape of the saccule, pressure, myoelectric signals, satisfactory saccule compression time and the like in real time outside the lead chamber during the operation.

The manual control system is connected with the injection pump, and the manual control system can start or stop the injection pump at any time.

The foregoing shows and describes the general principles, features and advantages of the present invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are intended to illustrate the principles of the utility model, but that various changes and modifications may be made without departing from the spirit and scope of the utility model, and the utility model is intended to be protected by the following claims. The scope of the utility model is defined by the appended claims and equivalents thereof.

Claims

1. A sacculus device for compression based on bioelectricity signals and pressure double feedback comprises a sacculus and a stimulation electrode, and is characterized in that the head end of the sacculus is provided with the stimulation electrode, a stimulation electrode lead is led out through a guide rod and is connected to an electrical stimulation output end of a stimulation electrode external interface connection myoelectricity monitoring device, an electromechanical signal receiving end is connected to masticatory muscles of a patient through needle electrodes to monitor myoelectricity changes of the masticatory muscles, and two Ruhr connectors at the tail end of the sacculus are respectively connected with an automatic injection pump and pressure monitoring equipment.

2. A compression balloon apparatus according to claim 1, wherein the control system is connected to the pressure monitoring device and the electrophysiological monitoring device, and the other end is connected to the automatic syringe pump.

3. A compression balloon device based on bioelectrical signals and pressure double feedback according to claim 1, wherein the control system comprises two parts, namely a pressure control system and an electromyographic detection control system.

4. The pressing balloon device based on bioelectric signal and pressure double feedback as claimed in claim 1, wherein the input end of the electromyographic physiological detection system is connected to the electromyographic monitoring device, receives masticatory myoelectric signals, and the output end thereof is connected to the automatic injection pump, after receiving the masticatory myoelectric signals, the system compares the signals with preset electromyographic threshold signals to make a judgment, if the monitoring value of the electromyographic signals does not reach the set threshold, the system does not intervene the bolus injection work of the automatic injection pump, and if the monitoring value of the electromyographic signals reaches or exceeds the set threshold, the system sends an instruction to the automatic injection pump to release the contrast agent injected into the balloon, and the operation is terminated.

5. A balloon compression device according to claim 1, wherein the stimulation electrode is made of metal material at the most distal end of the balloon catheter or made of ductile flexible electrode material integrated with the balloon wall.

6. A balloon apparatus for compression based on bioelectric signal and pressure dual feedback according to claim 1, wherein there is a manual termination device connected to the automatic syringe pump, which can be manually terminated at any time.

7. A compression balloon apparatus based on bioelectrical signals and pressure dual feedback according to claim 1, wherein the multi-functional mouth protector is made of polyvinyl chloride.

8. A compression balloon apparatus based on bioelectrical signal and pressure dual feedback according to claim 1, wherein the multi-functional mouth protector comprises a bite block, a tooth guard, and a tracheal tube fixing channel portion.