Multifunctional oral endotracheal tube fixation and anti-bite device for intraoperative electrophysiology

Abstract

The present invention relates to a multifunctional oral tracheal tube fixing and anti-bite device for intraoperative electrophysiology, comprising: a tooth pad body for inserting into a patient's oral cavity; a monitoring module arranged on / inside the tooth pad body to collect the occlusion data of the patient's teeth, and a processing module connected to the monitoring module signal, wherein the processing module is configured to: generate a morphological change scheme and / or an intraoperative electrical stimulation scheme of the tooth pad body matching the patient's teeth occlusion according to the pressure site changes and pressure size changes collected by the monitoring module during the patient's teeth occlusion. The present invention can solve the problem existing in the prior art, that is, when the patient's occlusal pressure changes, the tooth pad cannot be adjusted to a shape adapted to the current patient's teeth occlusion contour according to the pressure changes, and then a bite injury caused by the displacement of the tooth pad occurs. The present invention thus determines whether the electrical stimulation intensity is suitable for the patient according to the occlusion data, so as to explore a wider range of electrical stimulation schemes with richer treatment schemes while developing new anti-bite devices.

Description

Technical Field

[0001] The present invention relates to the technical field of medical instruments, and in particular to an anti-bite device, and in particular to a multifunctional oral endotracheal tube fixing anti-bite device for intraoperative electrophysiology. The device is mainly used for collecting bite data of neuroelectrophysiological detection for the collection and research of twitch data under MEP stimulation. Background Art

[0002] Some surgical procedures involving brain functional areas and invading the spinal cord are prone to cause irreversible damage to patients during the operation, and electrophysiological monitoring is often required to prevent the overall quality of life of patients, such as spinal cord stimulation. One of the complications associated with spinal cord stimulation is spinal cord injury. Studies have shown that the use of intraoperative neuroelectrophysiological monitoring can reduce accidental damage to neural structures and confirm the optimal position of the stimulator.

[0003] Neuroelectrophysiological monitoring is a method of examining the nervous system using electrophysiological instruments, mainly including electromyography, electroencephalography, motor evoked potentials, etc., which can determine whether there are lesions in the nervous and muscular systems. Motor evoked potentials (MEP) monitoring can be used to evaluate the functional integrity of descending motor nerve pathways through the internal capsule, brainstem, spinal cord and peripheral nerves. For example, it can assist in intraoperative localization of cerebral cortical functional areas and protect important functional conduction pathways during spinal canal surgery. MEP mainly includes high-voltage single-pulse electrical stimulation (referred to as electrical stimulation) and short-term high-intensity pulsed magnetic field stimulation (referred to as magnetic stimulation). Motor evoked potential monitoring can detect complications such as brain damage, epileptic seizures, epidural complications, accidental injuries caused by patient movement, bites, jaw fractures, adverse cognitive or emotional sequelae, arrhythmias, and intraoperative consciousness disorders. Among all these complications, the incidence of spontaneous tongue biting in patients is relatively high, reaching 0.63%, of which 0.14% require surgical repair and suture. Electrophysiological monitoring often requires monitoring of the patient's muscle activity, which can easily cause tongue bites when stimulating muscle groups, so it is often necessary to place two pieces of gauze or other things on both sides of the patient's mouth after anesthesia and endotracheal intubation to prevent bites. Gauze in the mouth poses a safety hazard and can easily remain in the mouth or even be accidentally swallowed into the stomach, causing harm to the patient.

[0004] In addition, this type of surgery usually has the following characteristics: the special surgical position (such as prone position) makes it impossible for the anesthesiologist to observe the patient's head and face in real time during the operation; the anesthesia method is mostly total intravenous anesthesia, and muscle relaxants are basically not allowed to be added during the operation; the operation time is long; muscle strength is restored during the operation, and at the same time there is strong electrical stimulation to cause muscle contraction. If the patient's dentures or dental pads placed after intubation are displaced during the operation, it will cause damage to the patient's tongue, and in severe cases it can lead to tongue necrosis.

[0005] The utility model with publication number CN217960905U provides a multifunctional oral tracheal tube fixing anti-bite tooth pad for intraoperative electrophysiology, the tooth pad comprising a base plate, a tracheal fixing tube arranged on the front side of the base plate and a bite pad arranged on the rear side of the base plate; the base plate, the tracheal fixing tube and the bite pad are all constructed to include left and right parts, so that the tooth pad is divided into a left half and a right half, the upper sides of the left half and the right half are connected by a loose-leaf, and the lower sides are connected by a lock; the tracheal fixing tube includes a tube hole passing through the base plate and the bite pad; the bite pad is arched, and the upper and lower sides of the bite pad respectively have an upper alveolar and a lower alveolar extending in an arch shape, and the defect is that when the patient's bite pressure changes, the tooth pad cannot be adjusted to a shape adapted to the current patient's tooth bite contour according to the change in pressure, so bite injuries caused by displacement of the tooth pad may occur. The tooth pad provided by the prior art has a fixed shape. When it is used in the oral cavity of a patient with dental deformities, the malocclusion may cause uneven force on the tooth pad, which may cause the tooth pad to shift during the operation and lose its function of preventing tongue bite. The tooth pad currently used in surgery is usually designed based on the equal bite force in different areas of the patient's mouth. However, during intraoperative neuroelectrophysiological monitoring, under the action of potential stimulation, the patient may experience convulsions, such as involuntary and paroxysmal twitching of facial muscles. When the face twitches, the bite force of the upper and lower teeth in different areas is not equal. The possible situations include at least: the bite force of the upper and lower teeth on one side of the face increases significantly, and the bite force on the other side decreases; the bite force of the upper and lower teeth of the central incisor and the adjacent area increases significantly, and the bite force of the upper and lower teeth of the permanent molar and the adjacent area decreases, etc., indicating that the bite force of the teeth in different areas during the operation is not equal.

[0006] The bite prevention device provided by the prior art is set based on the patient's equal bite force. In actual application, the bite prevention device is easily displaced or misplaced when the patient has convulsions or other unexpected situations that cause uneven bite force, and thus cannot effectively prevent the occurrence of bite injuries. On the other hand, the patient's own teeth are different. For example, some specific positions of the gums lack teeth, specific positions have short teeth or loose teeth. The occlusal surface of the existing bite pad is not suitable for the above situation. The occlusal surface and the teeth cannot be well contacted, resulting in the displacement or misplacement of the bite prevention device.

[0007] Therefore, a device capable of collecting the bite force data of patients is needed. Based on the data collected by the device, researchers can design anti-bite devices that are suitable for the bite conditions that may occur in different patients. On the other hand, the study "Motor evoked potentials (MEPs) during brainstem surgery can maintain cortical spinal function" proposed that "the increase in MEP stimulation intensity is interfered with by significant neck twitches in some cases, which can interfere with surgeons", indicating that intraoperative potential stimulation is closely related to the occurrence of twitches. When performing MEP, doctors usually combine their own experience and theoretical knowledge to set up monitoring plans for patients. The anti-bite device provided in this application can be used to explore the intensity of electrical stimulation during surgery, so as to explore the most effective electrical stimulation plan on the basis of ensuring patient safety.

[0008] In addition, there are also evidence-based medicine articles showing that there is a certain correlation between MEP stimulation and convulsions, but due to current technical means, it is impossible to collect a large amount of sample data to quantitatively analyze the degree of convulsions and provide a basis for more accurate treatment in the future.

[0009] Therefore, how to perform adaptive shape adjustment during surgery to avoid displacement and at the same time promptly confirm violent muscle movements while using the optimal stimulation intensity is an urgent problem to be solved by the new dental pad.

[0010] In addition, on the one hand, there are differences in understanding among those skilled in the art; on the other hand, the applicant studied a large number of documents and patents when making the present invention, but due to space limitations, not all details and contents are listed in detail. However, this does not mean that the present invention does not have the characteristics of these prior arts. On the contrary, the present invention already has all the characteristics of the prior art, and the applicant reserves the right to add relevant prior art to the background technology. Summary of the invention

[0011] Intraoperative transcranial electrical stimulation can cause the patient's masticatory muscles to contract and produce tooth clenching. In order to prevent or reduce excessive compression bite force caused by transcranial electrical stimulation, the prior art has developed a technical solution to optimize the stimulation position and stimulation parameters by monitoring the intraoperative tooth bite force. For example, the patent document with publication number CN112806997A discloses a device and method for monitoring intraoperative tooth bite force, wherein the device includes a bite force information acquisition module for acquiring tooth bite force information, a bite force information processing module for receiving the tooth bite force information transmitted by the bite force information acquisition module and calculating the tooth bite force value according to the bite force information, and a bite force information monitoring module for receiving and displaying the tooth bite force value transmitted by the bite force information processing module. In the technical solution, the intraoperative neural monitoring personnel can appropriately adjust the transcranial electrical stimulation position and parameters according to the tooth bite force value displayed by the bite force information monitoring module to reduce the tooth bite force, thereby preventing intraoperative oral injury. However, this technical solution only involves the collection of bite force information, and requires intraoperative neuromonitoring personnel to actively adjust the transcranial electrical stimulation position and parameters based on the monitored tooth bite force information. The adjustment at this time is limited to the parameter adjustment of the treatment method, and the technical solution does not involve the adjustment of the relevant parameters of the anti-bite device that directly affects the patient's bite protection status. Based on this, this technical solution does not involve the associated storage of bite force and stimulation signals, and cannot provide corresponding technical inspiration for the improvement of design parameters for fixed anti-bite devices, especially for the improvement of design parameters of fixed anti-bite devices used by different patients under different MEP stimulation.

[0012] In view of the shortcomings of the prior art, the present invention provides a multifunctional oral endotracheal tube fixing and anti-bite device for intraoperative electrophysiology, which is particularly suitable for collecting bite force data of the oral endotracheal tube fixing and anti-bite device under MEP stimulation and the main body morphology data of the tooth pad to provide data support for the improvement of the design parameters of the fixed anti-bite device, including:

[0013] A dental pad body for placement in a patient's oral cavity;

[0014] A monitoring module disposed on / inside the main body of the dental pad to collect the bite data of the patient's teeth, and a processing module connected to the signal of the monitoring module,

[0015] The processing module is configured as:

[0016] According to the changes in pressure sites and pressure magnitude during the patient's tooth occlusion collected by the monitoring module, a morphological change scheme of the tooth pad body and / or an intraoperative electrical stimulation scheme that matches the patient's tooth occlusion is generated.

[0017] Compared with the above-mentioned prior art, the processing module of the present invention can adjust the shape of the main body of the tooth pad according to the changes in the patient's tooth occlusal pressure under different electrical stimulations during surgery, or adjust the intraoperative electrical stimulation according to the changes in the tooth occlusal pressure, and can also analyze, store and utilize the bite force and the stimulation signal in temporal association. Based on the above-mentioned distinguishing technical features, the problems to be solved by the present invention may include: how to determine the most suitable main body shape of the tooth pad for the fixed anti-bite device under different electrical stimulation treatment parameters or the most suitable intraoperative electrical stimulation scheme under different main body shapes of the tooth pad. Beneficial effects of this technical solution: At present, neuroelectrophysiological monitoring has become a routine monitoring method for spinal surgery and neurosurgery. In the process of monitoring motor evoked potentials, due to the tonic contraction of the masseter muscle caused by electrical stimulation, the patient may bite the tongue too hard when in an unconscious state due to the upper and lower teeth biting. At the same time, there may also be problems of poor ventilation caused by broken teeth and bitten endotracheal tubes. Adverse events of oral injury during surgery often occur, such as displacement of the tooth pad, prolonged pressure on the oral cavity due to excessive opening and closing height of the tooth pad, etc. Due to differences in individual conditions of patients and possible adverse events during surgery, the anti-bite tooth pads provided by the prior art cannot cope with various problems that may arise during surgery, and there are no targeted data collection measures, let alone relevant and complete data to further develop appropriate technologies and medical devices. Therefore, the risk of bite injuries to patients during surgery cannot be reduced. The fixed anti-bite devices in the prior art need to be improved in structural design according to different usage environments and objects, and there is no fixed anti-bite device designed for this improvement need in the prior art.

[0018] In order to realize accurate monitoring of the bite force of teeth, the prior art has already presented a technical solution for monitoring the bite force of teeth through multiple contact surfaces. For example, the patent document with publication number CN114767116A discloses a bite force monitoring system, in which bite force acquisition modules are respectively arranged on the contact surface of the second dentition and the contact surface of the first dentition, and each bite force acquisition module includes a plurality of force measurement points distributed around the cusp of each tooth, so that the bite force monitoring system has a multi-channel stress acquisition capability, and can fully, comprehensively and accurately collect the bite data between the cusp and the cusp when the first dentition and the second dentition are occluded, and then fully, comprehensively and accurately obtain the bite force of the entire dentition. However, the main purpose of setting up the multi-faceted acquisition module in this technical solution is to obtain more accurate bite force data to realize oral restoration and orthodontic treatment, and it is impossible to adjust the fixed anti-bite device or the intraoperative electrical stimulation scheme according to the monitored bite force data. On the contrary, the present application sets a monitoring module on the main body of the dental pad placed in the patient's mouth to collect the occlusion data of the patient's teeth, thereby changing the shape of the main body of the dental pad and / or the intraoperative electrical stimulation scheme. Measuring a data in isolation cannot provide useful inspiration for the design of related products. By adjusting the stimulation scheme, a series of stimulation signals and occlusion data that are continuous in time can be obtained. In particular, during the monitoring process with a long operation time, the patient's occlusion state cannot be exactly the same. When the main body of the dental pad is initially placed, the main body of the dental pad is placed in the position expected by the doctor, but during the neuroelectrophysiological monitoring process, the patient is affected by the electrical stimulation, and the tension of the masticatory muscles will change. Furthermore, the force on the main body of the dental pad is uneven, so the main body of the dental pad may shift. Based on this problem, the monitoring module of the present application can monitor the force of the main body of the dental pad in real time during the operation to analyze the changes in the pressure site and the pressure size during the patient's tooth occlusion. After receiving the occlusion data, the processing module can generate a morphological change scheme and / or an intraoperative electrical stimulation scheme for the main body of the dental pad that matches the patient's tooth occlusion, and can collect data in a targeted manner to facilitate the further development of appropriate technologies and medical devices. On the one hand, the changes in the pressure points and pressure magnitude can reflect the changes in the bite force of the patient's specific tooth parts, so the shape of the tooth pad body can be adjusted in a targeted manner to ensure that the patient's tooth parts with abnormal bite force can still effectively contact the tooth pad body so that the tooth pad body is evenly stressed. Specifically, the corresponding points where the bite force increases reflect the tendency of the distance between the upper and lower teeth to decrease, which may lead to the risk of bite injury; the corresponding points where the bite force decreases reflect the risk of displacement due to the increase in the distance between the upper and lower teeth, which may lead to the inability of the teeth to contact the tooth pad body.On the other hand, changes in pressure points and pressure magnitudes can reflect the degree of influence of electrical stimulation on the patient. When the fluctuation frequency of pressure points and pressure magnitudes is high, it indicates that the contraction of the patient's masticatory muscles is seriously affected. Therefore, the present technical solution can also use changes in pressure points and pressure magnitudes on the dental pad body as a basis for adjusting the intensity of electrical stimulation to ensure the safety of the patient during surgery.

[0019] According to a preferred embodiment, the intelligent anti-bite device also includes an adjustment module arranged on / inside the tooth pad body and connected to the processing module signal, wherein the adjustment module includes a plurality of expansion units distributed at different locations of the tooth pad body and a micro pump for providing gas pressure to the expansion units, and the processing module is configured to: control the shape of the expansion units at different locations of the tooth pad body according to the generated shape change scheme of the tooth pad body, so that the tooth pad body can fit the patient's teeth, thereby reducing the probability of tongue biting and oral bruises.

[0020] Compared with the above-mentioned prior art, the intelligent anti-bite device of the present invention can adjust the specific shape of the tooth pad body according to the shape change scheme of the tooth pad body, so as to explore some feasible design schemes for future related product development. Based on the above-mentioned distinguishing technical features, the problems to be solved by the present invention may include: how to ensure that the tooth pad body of the fixed anti-bite device under different electrical stimulation treatment parameters maintains a high degree of fit with the patient's teeth. Specifically, the beneficial effects of the technical solution: the present application changes the shape of the tooth pad by setting an expansion unit at different positions of the tooth pad body, and in particular, the change in the shape of the tooth pad matches the change in the bite position and bite force of the patient's teeth. The shape of the expansion unit can be achieved by the inflation and deflation of a micro pump. Compared with the fixed-shaped tooth pad device provided by the prior art, the intelligent anti-bite device provided by the present application can form an adaptive tooth pad shape based on the changes in the bite position and bite force of the patient's teeth. In the case of changes in the bite position and bite force, the tooth pad body can still have a high degree of fit with the patient's teeth, ensuring that the tooth pad body is supported by sufficient force inside the oral cavity and reducing the probability of displacement of the tooth pad body. In addition, since the shape of the expansion unit is controlled by the inflation / deflation volume provided by the micro pump, the air pressure inside it is adjustable, that is, the force exerted by the expansion unit on the teeth is adjustable. The pressure of the expansion unit can be set according to the specific bite situation to avoid the situation where the expansion unit squeezes the patient's mouth too much or the internal pressure of the expansion unit is insufficient, causing the patient to bite the tongue. This degree of expansion is measurable and recordable, and is stored in time association with the electrical stimulation scheme, bite force, etc., for subsequent analysis and improvement.

[0021] Specifically, in some cases, the patient's teeth have an increased or decreased bite force in a specific area. For the expansion unit at the corresponding position of the tooth pad body where the bite force is increased, it can be pressurized under the action of a micro pump to increase the distance between the upper teeth and the lower teeth at this position, thereby avoiding the situation where the teeth at this position are loose or fall off due to excessive bite force, or even bite the tongue. On the other hand, for the expansion unit at the corresponding position of the tooth pad body where the bite force is reduced, it can be pressurized under the action of a micro pump to make the teeth at this position directly contact with the tooth pad body, increase the contact area between the teeth and the tooth pad body, and this setting can reduce the risk of displacement due to uneven force or insufficient support of the tooth pad. In addition, for the patient's teeth are deformed, such as a lack of teeth at a specific position of the gums, short teeth, loose teeth, etc., the teeth cannot apply enough force to the tooth pad body, so it is very likely that the tooth pad will shift during the operation. When the bite pad is displaced, the patient is prone to bite his tongue due to electrical stimulation; or the channel of the endotracheal tube is bitten by the patient and the channel is blocked.

[0022] According to a preferred embodiment, for example, to explore some feasible design solutions for future related product development, the processing module may also be configured as follows:

[0023] When the changes in the pressure point and the pressure magnitude during the patient's tooth occlusion process are manifested as uniform pressure when the upper and lower teeth in each zone are in contact and the first bite force of normal occlusion in the preoperative conscious state changes to the bite force of the teeth in the upper left zone and the lower left zone exceeding the first bite force, and the bite force of the teeth in the upper right zone and the lower right zone being lower than the first bite force, a prompt instruction is generated that the tooth pad body has a risk of displacement, wherein the prompt instruction of the risk of displacement of the tooth pad body is stored in a manner temporally associated with the electrical stimulation signal to facilitate subsequent analysis and improvement.

[0024] According to a preferred embodiment, for example, to explore some feasible design solutions for future related product development, the processing module may also be configured as follows:

[0025] When the changes in the pressure point and the pressure magnitude during the patient's tooth occlusion process are manifested as uniform pressure when the upper and lower teeth in each zone are in contact and the first bite force of normal occlusion in the preoperative conscious state changes to the bite force of the teeth in the upper right zone and the lower right zone exceeding the first bite force, and the bite force of the teeth in the upper left zone and the lower left zone being lower than the first bite force, a prompt instruction is generated that the tooth pad body has a risk of displacement, wherein the prompt instruction of the risk of displacement of the tooth pad body is stored in a manner temporally associated with the electrical stimulation signal to facilitate subsequent analysis and improvement.

[0026] Compared with the above-mentioned prior art, the processing module of the intelligent anti-bite device of the present invention can generate a prompt instruction that the main body of the tooth pad has a risk of displacement according to the changes in the pressure site and the pressure size during the patient's tooth occlusion, and in particular, the prompt instruction is stored in a manner that is temporally associated with the electrical stimulation signal. Based on the above-mentioned distinguishing technical features, the problems to be solved by the present invention may include: how to monitor the phenomenon of displacement of the main body of the tooth pad due to uneven force, so as to facilitate subsequent analysis and improvement of the design of the main body of the tooth pad to be mass-produced. Specifically, the beneficial effects of the present technical solution are as follows: when the patient's tooth occlusion changes from the initial uniform occlusion to differences in bite force in different areas, it means that the patient's force applied to the tooth pad is uneven at this time. Specifically, the bite force of the teeth in the upper left area and the lower left area is greater than normal, and the bite force of the teeth in the upper right area and the lower right area is smaller than normal, or the bite force of the teeth in the upper left area and the lower left area is smaller than normal, and the bite force of the teeth in the upper right area and the lower right area is greater than normal. In the above situations, the tooth pad body is subjected to uneven force (one end of the tooth pad body is subjected to a large force, and the other end is subjected to a small force), and the tooth pad body cannot maintain balance. When the duration is too long, the tooth pad is likely to shift.

[0027] Furthermore, the opening of one end of the dental pad body subjected to a large force is reduced, and the corresponding distance between the upper and lower teeth is reduced; the opening of the other end of the dental pad body subjected to a small force is increased, and the corresponding distance between the upper and lower teeth is increased. When the duration is too long, the skin at the end of the dental pad body with an increased opening is compressed, and the corners of the mouth may be torn. For surgery in the prone position, the forces at both ends of the dental pad body are uneven, and coupled with the effect of gravity, the dental pad body is easily displaced. Therefore, when the forces at both ends of the dental pad body are uneven, the processing module generates a prompt instruction that the dental pad body has a risk of displacement, and promptly reminds the medical staff to check the insertion of the patient's dental pad body and adjust the dental pad body. At this time, while the prompt instruction is stored in a time-related manner with the electrical stimulation signal, the situation after the medical staff's examination is also stored in a time-related manner, so as to facilitate subsequent analysis and improvement of the dental pad body to be mass-produced.

[0028] According to a preferred embodiment, the intelligent anti-bite device can be used in conjunction with an alarm module, wherein the processing module of the intelligent anti-bite device is connected to the alarm module signal, and the alarm module issues an alarm prompt after receiving the prompt instruction of the processing module, wherein the alarm prompt is stored in a manner temporally associated with the electrical stimulation signal to facilitate subsequent analysis and improvement.

[0029] Preferably, the alarm prompt can be one or more of a sound prompt, a light prompt, and a vibration prompt.

[0030] Preferably, the alarm module can be an intelligent electronic device, an alarm, a warning light, etc.

[0031] The beneficial effects of the present technical solution are as follows: the alarm module is used to issue corresponding alarm prompts according to the prompt instructions issued by the processing module, so that medical staff can quickly and clearly obtain the abnormal bite conditions of the patient, wherein the alarm prompts and the abnormal bite conditions confirmed by the medical staff are stored in a manner temporally associated with the electrical stimulation signal to facilitate subsequent analysis and improvement.

[0032] According to a preferred embodiment, for example, to explore some feasible design solutions for future related product development, the processing module may also be configured as follows:

[0033] When the bite force of the upper and lower teeth at both ends of the patient's mouth corners exceeds the first bite force, the air pressure of the expansion unit at the upper and lower teeth points corresponding to the upper and lower teeth at both ends of the mouth corners on the tooth pad body is adjusted to the first air pressure to increase the distance between the upper and lower teeth at both ends of the mouth corners, and at the same time, an intraoperative electrical stimulation plan for reducing the electrical stimulation intensity is output, wherein the degree of reduction in the electrical stimulation intensity and the distance confirmed by the medical staff are stored in a manner that is temporally associated with the electrical stimulation signal to facilitate subsequent analysis and improvement.

[0034] Compared with the above-mentioned prior art, the processing module of the intelligent anti-bite device of the present invention can adjust the air pressure parameters of the expansion unit at the corresponding position according to the changes in the bite force of the upper and lower teeth at both ends of the patient's mouth corners. Based on the above-mentioned distinguishing technical features, the problems to be solved by the present invention may include: how to more effectively improve the equipment to be mass-produced to prevent patients from over-biting and causing oral damage to patients. Specifically, the beneficial effects of the present technical solution: based on the structural characteristics of human teeth, the order of bite force is: first molar> second molar> third molar> second premolar> first premolar> canine> central incisor> lateral incisor, that is, the bite force of the upper and lower teeth near the two ends of the mouth corners is greater than the bite force of the teeth in the middle. When the bite force of the upper and lower teeth near the two ends of the mouth corners has a certain distance under the support of the expansion unit, the teeth in the middle cannot cause damage to the tongue. Based on this, when the bite force of the upper teeth and lower teeth at both ends of the mouth corners exceeds the first bite force, the air pressure of the expansion unit corresponding to the upper teeth and lower teeth at both ends of the mouth corners is increased to the first air pressure, wherein the first air pressure can ensure that the upper teeth and lower teeth at both ends of the mouth corners have a certain distance. At the same time, due to the increase in the air pressure of the expansion unit close to the mouth corners, the two ends of the tooth pad body are affected by the change in the air pressure of the expansion unit, and the opening distance increases to cause pressure on the corners of the mouth. When this process lasts for a long time, the tooth pad body is prone to cause compressive damage to the patient's mouth corners or cause the corners of the mouth to tear. Therefore, the technical solution simultaneously generates a solution to reduce the intensity of electrical stimulation, and comprehensively collects electrical stimulation data and occlusion conditions to improve the electrical stimulation solution or effectively improve the equipment to be mass-produced, thereby reducing the time of abnormal bite of the patient during the operation. When the patient's abnormal bite is restored, the air pressure of the expansion unit can be reduced to reduce the pressure time of the tooth pad body on the patient's mouth corners.

[0035] According to a preferred embodiment, the adjustment of the intensity of electrical stimulation includes the adjustment of the intermittent time of electrical stimulation and the current intensity. The intermittent time of electrical stimulation and the current intensity have an impact on the impedance dependence and continuous expression during the stimulation process, and can be adjusted according to the abnormal conditions that occur in different individuals during the monitoring process. The intermittent time of electrical stimulation, the degree of adjustment of the current intensity, and the abnormal conditions confirmed by the medical staff are stored in a manner that is temporally associated with the electrical stimulation signal to facilitate subsequent analysis and improvement.

[0036] According to a preferred embodiment, for example, to explore some feasible design solutions for future related product development, the processing module is further configured to:

[0037] When the bite force of the upper and lower teeth at both ends of the patient's mouth corners exceeds the first bite force, the air pressure of the expansion unit at the middle point between the two ends of the mouth corners on the dental pad body is adjusted to a second air pressure, wherein the second air pressure is greater than the first air pressure.

[0038] In order to more effectively improve the device to be mass-produced, the beneficial effects of the technical solution also include: when the bite force of the upper teeth and the lower teeth at both ends of the mouth corners exceeds the first bite force, the air pressure of the expansion unit at the middle point between the two ends of the mouth corners is increased to the second air pressure, wherein the second air pressure is greater than the first air pressure. This setting is conducive to reducing the pressure of the two ends of the tooth pad body on the mouth corners. At the same time, because the second air pressure is greater than the first air pressure, the deformation of the expansion unit at the middle point of the tooth pad body is larger, and the distance between the upper teeth and the lower teeth at the corresponding middle point is larger. Theoretically, the bite force of the teeth near the two ends of the mouth corners is greater. When the bite force of the upper teeth and lower teeth at the two ends of the mouth corners exceeds the first bite force, the air pressure of the expansion unit at the corresponding points at the two ends of the mouth corners should be adjusted. Instead, the technical solution adjusts the air pressure of the expansion unit at the middle point between the two ends of the mouth corners. This is because, after the air pressure of the expansion unit at the middle point increases to the second air pressure, since the second air pressure is greater than the first air pressure, the deformation of the expansion unit at the middle point causes the middle point of the tooth pad body to have a sufficient distance, so that a certain distance is left between the upper teeth and lower teeth near the two ends of the mouth corners, avoiding the teeth near the mouth corners from biting the tongue. In addition, after the bite force of the upper teeth and lower teeth at the two ends of the mouth corners increases, the force of the teeth on the tooth pad body is equal to the reaction force of the tooth pad body on the mouth corners, so it is easy to cause the mouth corners to be compressed and bruised. This technical solution collects the bite data of the patient's electrical stimulation scheme that is temporally related, providing ideas and directions for the development of future anti-bite products.

[0039] This technical solution can achieve the purpose of reducing the pressure on the corners of the mouth only by the air pressure of the expansion unit at the middle point between the two ends of the corners of the mouth during the preclinical and clinical trial stages of the product, without changing the intraoperative electrical stimulation scheme to reduce the recovery time of the patient's abnormal bite. Generally speaking, the electrical stimulation scheme is set by the doctor according to the patient's condition. The original intraoperative electrical stimulation scheme can ensure the effect of the operation and end the operation as soon as possible, while reducing the compressive damage of the dental pad body to the corners of the mouth during the operation. This avoids unnecessary and excessive injuries to the test personnel.

[0040] According to a preferred embodiment, for example, to explore some feasible design solutions for future related product development, the processing module may also be configured as follows:

[0041] When the fluctuation frequency of the patient's tooth biting force exceeds the first preset frequency and reflects that the patient's masticatory muscle contraction is enhanced to a certain extent, increasing the air pressure of the expansion unit;

[0042] When the fluctuation frequency of the patient's tooth biting force exceeds the second preset frequency, which reflects that the patient's masticatory muscles are too strongly contracted, the air pressure of the expansion unit is increased, and the electrical stimulation interval is increased and / or the current intensity is reduced.

[0043] The second preset frequency is greater than the first preset frequency.

[0044] In order to more effectively improve the equipment to be mass-produced, the beneficial effects of the present technical solution also include: during the neuroelectrophysiological monitoring process, after the patient is electrically stimulated, his bite force will fluctuate. The present technical solution obtains the fluctuation frequency of the tooth bite force through the bite data of the patient collected by the monitoring module, and then determines the degree of influence of the electrical stimulation on the patient. Specifically, when the fluctuation frequency of the patient's tooth bite force exceeds the first preset frequency, it means that compared with the normal situation, the patient's masticatory muscle contraction is enhanced to a certain extent. This phenomenon may cause the tongue to be bitten. This is because: the fluctuation of the bite force includes the alternation of increased bite force and decreased bite force, or the bite force continues to increase, or the bite force continues to decrease. When the bite force increases, the force of the teeth on the main body of the tooth pad increases, causing the opening distance of the main body of the tooth pad to decrease, so it is easy to bite the tongue. When the bite force decreases, the force between the teeth and the main body of the tooth pad decreases, causing the fixing effect or supporting effect of the teeth on the main body of the tooth pad to be weakened. In this case, the main body of the tooth pad is easy to shift. Therefore, when the fluctuation frequency of the tooth bite force exceeds the first preset frequency, the distance between the upper and lower teeth is increased by increasing the air pressure of the expansion unit, while ensuring that there is sufficient interaction force between the teeth and the main body of the dental pad, which can reduce the risk of bite injury and the probability of displacement of the main body of the dental pad. This avoids unnecessary and excessive injuries to testers in the preclinical and clinical trial stages of the product, and can also explore a wider range of boundary conditions as much as possible, which is also conducive to enriching treatment plans.

[0045] When the fluctuation frequency of the patient's tooth bite force exceeds the second preset frequency (the second preset frequency is greater than the first preset frequency), it means that the patient's masticatory muscle contraction is too strong. This phenomenon may be due to the fact that the electrical stimulation scheme is not suitable for the patient, thus causing excessive adverse reactions in the patient. Based on this problem, the present application simultaneously implements a scheme of increasing the air pressure of the expansion unit and increasing the electrical stimulation interval time and / or reducing the current intensity to ensure that the patient's masticatory muscle contraction function is restored as soon as possible, and reduce the probability of the patient biting and the displacement of the tooth pad body. In this way, the masticatory muscle contraction function of the relevant testers can be effectively protected, and a wider range of tooth bite force fluctuation frequency boundary conditions can be explored as much as possible, which is also conducive to the enrichment of treatment plans.

[0046] For the same consideration, on the other hand, the fluctuation frequency of the tooth bite force can reflect to a certain extent whether the patient's physical condition matches the electrical stimulation program. When the fluctuation frequency of the patient's tooth bite force exceeds the second preset frequency, it means that the patient's body cannot adapt to the electrical stimulation program. The doctor can increase the electrical stimulation interval time and / or reduce the current intensity according to the fluctuation frequency of the tooth bite force to reduce the frequency of the patient's bite abnormalities.

[0047] According to a preferred embodiment, the dental pad body comprises an occlusal surface in direct contact with the teeth and an extrusion surface in contact with the tongue and cheeks of the patient, wherein the occlusal surface is connected to the extrusion surface in an orthogonal manner.

[0048] In order to more effectively improve the devices to be mass-produced, the beneficial effects of this technical solution may include: the occlusal surface is in direct contact with the patient's teeth, the extrusion surface is in conflict with the patient's tongue and cheeks, so that the tongue and cheeks are avoided from the occlusal range of the teeth, and the orthogonal arrangement of the occlusal surface and the extrusion surface can reduce the probability of the tongue and cheeks being bitten by the teeth. In this way, the boundary conditions for applying stimulation signals in a wider range can be explored within a safe range.

[0049] According to a preferred embodiment, for example, to explore some feasible design solutions for the development of related products in the future, the processing module may also be configured as follows:

[0050] According to the first contour of the occlusal surface of the patient's teeth in the awake state before the operation, which reflects the tooth deformity state, the monitoring module increases the air pressure of the expansion unit at the position corresponding to the tooth deformity on the main body of the dental pad, so that the deformed teeth can directly contact the occlusal surface of the main body of the dental pad to ensure the uniform force of the main body of the dental pad. This can adapt to different clinical trial subjects and explore the boundary conditions of the application of a wider range of stimulation signals in a safer range.

[0051] The beneficial effects of the technical solution: different patients have different tooth deformities, for example: some patients have missing teeth in certain positions of their gums; some patients' teeth are damaged and broken, so they are shorter; some patients' teeth are loose and cannot exert sufficient force on the main body of the dental pad. In view of the above situation, the technical solution obtains whether the patient's teeth are deformed by collecting the first contour of the occlusal surface of the patient's teeth in the awake state before the operation, and at the same time increases the air pressure of the expansion unit corresponding to the position of the tooth deformity on the main body of the dental pad according to the specific deformity of the teeth reflected by the first contour, so as to ensure that when the patient inserts the main body of the dental pad before the operation, the deformed teeth can fit with the corresponding position of the main body of the dental pad, and exert sufficient force on the corresponding position of the main body of the dental pad. When the main body of the dental pad is evenly stressed, the risk of displacement of the dental pad is reduced, and the safety of the patient during the operation is also higher. This expansion degree is measurable and recordable, and is stored in time association with the electrical stimulation scheme, bite force, etc., for subsequent analysis and improvement.

[0052] According to a preferred embodiment, the shape change of the dental pad body is achieved by changing the air pressure of the expansion unit.

[0053] According to a preferred embodiment, the intelligent anti-bite device can be used in conjunction with an external display device, wherein the processing module of the intelligent anti-bite device is connected to the external display device signal, so that the external display device displays the parameters related to the intensity of the electrical stimulation that need to be adjusted after receiving the intraoperative electrical stimulation scheme generated by the processing module. This avoids unnecessary excessive intensity injuries to testers during the preclinical and clinical trial stages of the product, and can also explore a wider range of boundary conditions as much as possible. The electrical stimulation signal and the bite data are stored in a temporally correlated manner, which is conducive to the enrichment of treatment plans and the exploration of new tooth pads.

[0054] Preferably, the external display device can be a display screen, such as a CRT display, an LCD display, an LED display, etc.

[0055] The beneficial effects of this technical solution are as follows: the external display device is used to display the parameters related to the electrical stimulation intensity that need to be adjusted, which helps medical staff to quickly and intuitively obtain the parameters that need to be adjusted, and these parameters are key contents required for subsequent product improvements, such as by storing them in association with the stimulation signal in time.

[0056] According to a preferred embodiment, the monitoring module includes a plurality of pressure monitoring units, wherein the pressure monitoring units are arranged on the occlusal surface of the tooth pad body corresponding to the positions of the teeth, so as to collect the occlusal forces of the teeth at different positions.

[0057] According to a preferred embodiment, the micro pump controls the air pressure of the expansion unit by inflating or deflating the expansion unit, thereby changing the shape of the expansion unit.

[0058] According to a preferred embodiment, the processing module may also be configured as follows:

[0059] When the patient's tooth bite force is less than the first bite force and the fluctuation frequency is less than the first preset frequency, reflecting that the patient's masticatory muscle contraction has returned to normal, the micropump is controlled to deflate the expansion unit to reduce the pressure time of the expansion unit on the patient's mouth, thereby improving the comfort of the clinical trial subjects. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] Figure 1 It is a simplified schematic diagram of module connection relationship of an intelligent bite prevention device applied to neuroelectrophysiological monitoring according to a preferred embodiment of the present invention;

[0061] Figure 2 It is a structural schematic diagram of a tooth pad main body according to a preferred embodiment of the present invention;

[0062] Figure 3 It is a structural schematic diagram of an expansion unit according to a preferred embodiment of the present invention;

[0063] Figure 4 It is an anti-bite block in the prior art;

[0064] Figure 5 It is another anti-bite block in the prior art;

[0065] Figure 6 The utility model relates to an anti-bite teeth pad in the prior art.

[0066] Reference numerals list

[0067] 100: dental pad body; 110 occlusal surface; 111: upper side surface; 112: lower side surface; 120: extrusion surface; 121: inner side surface; 122: outer side surface; 130: pressure sensor; 200: monitoring module; 210: pressure monitoring unit; 300: processing module; 400: regulating module; 410: expansion unit; 411: first air bag; 412: second air bag; 413: third air bag; 414: fourth air bag; 420: micro pump. DETAILED DESCRIPTION

[0068] The following is a detailed description with reference to the accompanying drawings.

[0069] The patients in this application mainly refer to those who undergo neuroelectrophysiological monitoring.

[0070] According to the oral dentition division, the tooth pad body 100 or the position of the teeth in this application is divided into the upper left area, the upper right area, the lower left area and the lower right area. The tooth position is divided by the middle seam of the front teeth. The number of teeth in each area from front to back is the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, and 8th.

[0071] Bite force refers to the chewing pressure generated by the contraction of the masticatory muscles when the upper and lower teeth come into contact. In this application, the bite force is expressed in kg.

[0072] Example 1

[0073] This embodiment provides a multifunctional oral endotracheal tube fixing and anti-bite device for intraoperative electrophysiology, such as Figures 1-2 As shown. The anti-bite device is mainly used to collect the patient's bite data during intraoperative electrophysiological monitoring to help researchers design devices that match different convulsion conditions that may occur in patients during surgery. Furthermore, the bite data collected by the anti-bite device can also be used to explore electrical stimulation schemes (electrical stimulation intensity, stimulation site, etc.), and to find the patient's MEP threshold or the electrical stimulation intensity with the best therapeutic effect while ensuring the safety of the patient. Because patients may experience a variety of emergencies during surgery, especially involuntary and paroxysmal convulsions, in this case, the bite forces of the upper and lower teeth in each area are not equal, and the existing anti-bite devices are designed for equal bite conditions, which can easily cause displacement due to uneven bite during use. Figures 4-5The anti-bite block provided by the prior art is placed between the upper teeth and the lower teeth on one side of the oral cavity. Due to the different convulsions that may occur in patients during intraoperative electrophysiological monitoring, such as different degrees of convulsion severity, changes in the location of bite force changes caused by convulsions, etc., the anti-bite block can only be placed on one side during the operation. During a long operation, the size and shape of the anti-bite block are not suitable for the patient's oral cavity, which may cause compression and bruises on the corners of the patient's mouth or other adjacent parts; or, the patient's bite force changes due to convulsions during the operation, causing the anti-bite block to shift or detach from the oral cavity, resulting in bite injuries or affecting the doctor's operation. Figure 6 An anti-bite pad provided in the prior art, when placed in the patient's mouth, if the patient's bite force on one side is reduced and on the other side is increased, the teeth on the side with reduced bite force have poor contact with the anti-bite pad, which may cause the anti-bite pad to shift. On the other hand, when the patient has deformed teeth, the deformed part cannot exert sufficient force on the anti-bite pad, and the anti-bite pad is easily shifted or misplaced.

[0074] Therefore, this embodiment provides an anti-bite device to collect the patient's bite data during surgery. Researchers can design an anti-bite device based on individual-specific bite data that can cope with different twitching conditions or different bite changes during surgery. At the same time, intraoperative electrophysiological monitoring usually requires auxiliary endotracheal intubation to help ventilation. If the anti-bite device is displaced or misplaced, the endotracheal intubation will be squeezed or even accidentally removed, causing poor ventilation for the patient. Therefore, researchers use the bite data collected by the anti-bite device provided in this embodiment to design a new anti-bite device that is different from the prior art, which can reduce the occurrence of ventilation obstruction caused by accidents during surgery.

[0075] The anti-bite device provided in this embodiment includes a tooth pad body 100, a monitoring module 200 and a processing module 300. The tooth pad body 100 is used to be placed in the patient's mouth to prevent the patient from biting the tongue or cheeks. Its shape or form is not the subject of protection of the present invention, but the applicant reserves the right to apply for a separate design patent for protection; in this regard, those skilled in the art can think of various shapes, such as Figure 6 As shown in the prior art. The monitoring module 200 is used to collect the bite data of the patient's teeth. The bite data includes the bite position and the size of the bite force. The monitoring module 200 is arranged on / in the tooth pad body 100. The monitoring module 200 is connected to the processing module 300 by signal. Preferably, the signal connection method between the monitoring module 200 and the processing module 300 is, for example, a radio frequency signal, a WIFI signal, a Bluetooth signal, etc. The processing module 300 receives the monitoring data of the monitoring module 200 and stores it in the memory.

[0076] According to a preferred embodiment, the processing module 300 is configured to generate a morphological change scheme and / or an intraoperative electrical stimulation scheme of the tooth pad body 100 that matches the patient's tooth occlusion according to the pressure site changes and pressure magnitude changes during the patient's tooth occlusion process collected by the monitoring module 200. According to the present invention, the pressure site changes and pressure magnitude changes are recorded in time in association with the intraoperative electrical stimulation signal for analysis and matching, wherein the intraoperative electrical stimulation signal is applied discretely in time, wherein the pressure value during the patient's tooth occlusion process that is time-lag behind the acquisition of the electrical stimulation signal is stored in a manner related to the waveform and amplitude of the intraoperative electrical stimulation signal, wherein the intraoperative electrical stimulation scheme is adjusted in a negative feedback manner, wherein the actual pressure value during the patient's tooth occlusion process is compared with the ideal patient's tooth occlusion pressure value, and the pressure difference obtained by comparison not only reflects the pressure magnitude change, but also constitutes the input parameter of the negative feedback adjustment, thereby being able to reduce the intensity of manual operation intervention while avoiding adverse events. In the present invention, the ideal patient tooth occlusal pressure value can be manually set by the doctor during the operation, or it can be set in a fluctuating manner according to a preset program, such as increasing, decreasing, increasing, decreasing, etc. In the case of setting a series of ideal patient tooth occlusal pressure values ​​in a fluctuating manner according to a preset program, the processing module 300 can associate and analyze the actual pressure value of the patient's tooth occlusion process with the intraoperative electrical stimulation signal according to the time sequence of the preset program, and store them. The actual pressure value of the patient's tooth occlusion process and the intraoperative electrical stimulation signal stored in a temporally associated manner can also be further processed by the processing module 300, for example, classified and stored in a manner related to the patient's personal data such as the course of disease, gender, age, etc., and can also be stored in association with the EEG signal (due to the nonlinear change of the electroencephalogram EEG), so as to facilitate the subsequent further analysis of the treatment effect.

[0077] Preferably, the monitoring module 200 includes a plurality of pressure monitoring units 210, wherein the pressure monitoring units 210 are arranged on the occlusal surface 110 of the tooth pad body 100 corresponding to the position of the teeth, so as to collect the occlusal force of the teeth at different positions. Specifically, the pressure monitoring unit 210 is a pressure sensor 130. A plurality of pressure sensors 130 are arranged in the bitten area of ​​the tooth pad body 100, which can collect the pressure applied by the upper and lower teeth and the position where the pressure is applied.

[0078] Preferably, the processing module 300 can be configured as a microprocessor. Preferably, the microprocessor is disposed inside the dental pad body 100 .

[0079] There are many situations in which the pressure points and pressure magnitudes change during tooth occlusion, for example: the bite force of the teeth in the upper left, lower left, upper right and lower right zones on the bitten area of ​​the tooth pad increases; the bite force of the teeth in the upper left, lower left, upper right and lower right zones on the bitten area of ​​the tooth pad decreases; the bite force of the teeth in the upper left and lower left zones on the bitten area of ​​the tooth pad increases while the bite force of the teeth in the upper right and lower right zones on the bitten area of ​​the tooth pad decreases; the bite force of the teeth in the upper left and lower left zones on the bitten area of ​​the tooth pad decreases while the bite force of the teeth in the upper right and lower right zones on the bitten area of ​​the tooth pad increases. These are only some examples, and other situations are not listed one by one.

[0080] According to a preferred embodiment, the intelligent anti-bite device further comprises an adjustment module 400 disposed on / inside the tooth pad body 100 and connected to the processing module 300 by signal, wherein the adjustment module 400 comprises a plurality of expansion units 410 distributed at different locations of the tooth pad body 100 and a micro pump 420 for providing gas pressure to the expansion unit 410. Preferably, the expansion unit 410 can be an air bag.

[0081] The dental pad body 100 includes an occlusal surface 110 directly contacting the teeth and an extrusion surface 120 contacting the tongue and cheeks of the patient, wherein the occlusal surface 110 and the extrusion surface 120 are connected in an orthogonal manner. Preferably, airbags are arranged on the occlusal surface 110 and the extrusion surface 120.

[0082] According to a preferred embodiment, the processing module 300 is configured to: control the morphology of the expansion unit 410 at different positions of the tooth pad body 100 according to the generated morphology change scheme of the tooth pad body 100, so that the tooth pad body 100 can fit the patient's teeth, thereby reducing the probability of tongue biting and oral bruising. The expansion degree of the expansion unit 410 and the corresponding expansion position are measurable and recordable, which can be used to explore the boundary conditions of the tooth occlusal force fluctuation frequency, thereby facilitating the improvement and enrichment of the treatment plan. The morphology change of the tooth pad body 100 is achieved by changing the air pressure of the expansion unit 410. The micro pump 420 controls the air pressure of the expansion unit 410 by inflating or deflating the expansion unit 410, thereby changing the morphology of the expansion unit 410.

[0083] The morphological change scheme of the dental pad body 100 includes: ① the bite force of the teeth at a specific position increases, and the air bag at the specific position is inflated to increase the air pressure. The shape of the air bag changes after the air pressure increases, thereby causing the change of the dental pad shape; ② the bite force of the teeth at a specific position decreases, and the air bag at the specific position is inflated to increase the air pressure; ③ the bite force of the teeth at a specific position fluctuates in an alternating manner of increase and decrease, and the air bag at the specific position is inflated to increase the air pressure; ④ the teeth at a specific position are missing or the teeth are too short, resulting in the teeth being unable to directly contact the dental pad body 100, and the air bag at the specific position is inflated so that the dental pad body 100 at the specific position can be subjected to sufficient force; ⑤ the teeth at a specific position are loose, resulting in the specific position being unable to be subjected to sufficient force. This situation can be solved by collecting the first contour of the occlusal surface 110 of the patient's teeth before surgery to obtain the deformity of the teeth in advance, and then adjusting the air pressure of the expansion unit 410 at the corresponding position of the tooth deformity.

[0084] Preferably, the adjustment of the electrical stimulation intensity includes the adjustment of the electrical stimulation intermittent time and the current intensity.

[0085] The intraoperative electrical stimulation plan includes: ① When the fluctuation frequency of the tooth bite force exceeds the set frequency, increase the electrical stimulation interval time and / or reduce the current intensity; ② When the bite force of the upper and lower teeth at both ends of the mouth corners exceeds the set bite force, increase the electrical stimulation interval time and / or reduce the current intensity.

[0086] According to a preferred embodiment, the morphological change scheme of the dental pad body 100 and the intraoperative electrical stimulation scheme can be applied simultaneously or only one of them can be applied. The technical solution provided in this embodiment can not only explore some feasible design schemes for related product development to more effectively improve the instruments to be mass-produced, but also explore the boundary conditions of a wider range of electrical stimulation based on the bite force and electrical stimulation scheme that are stored in a temporally associated manner, which is conducive to enriching the treatment scheme.

[0087] According to a preferred embodiment, the processing module 300 is configured to generate a prompt instruction that the tooth pad body 100 has a risk of displacement when the pressure site changes and the pressure size changes during the patient's tooth occlusion process, which is manifested as uniform pressure when the upper and lower teeth of each zone are in contact and the first bite force of normal occlusion in the preoperative awake state changes to the bite force of the teeth in the upper left zone and the lower left zone exceeding the first bite force, and the bite force of the teeth in the upper right zone and the lower right zone is lower than the first bite force. The prompt instruction of the risk of displacement of the tooth pad body is stored in time association with the electrical stimulation scheme, the bite force, etc., for subsequent analysis and improvement.

[0088] Preferably, the first bite force can be set to 20-30 kg. Specifically, the first bite force can be set to 20 kg, 23 kg, 25 kg, 28 kg, or 30 kg.

[0089] For example: Under normal circumstances, the bite forces of the teeth in the upper left and lower left areas, and the upper right and lower right areas of the patient are 20kg and 19.8kg respectively. During the operation, the bite forces of the teeth in the upper left and lower left areas are 23kg, and the bite forces of the teeth in the upper right and lower right areas are 10kg. This situation indicates that the force on the tooth pad body 100 is uneven, and the processing module 300 generates a prompt instruction that the tooth pad body 100 has a risk of displacement.

[0090] According to a preferred embodiment, the processing module 300 is configured as follows: when the pressure point and pressure magnitude changes during the patient's tooth occlusion process are manifested as uniform pressure when the upper and lower teeth in each zone are in contact and the first bite force of normal occlusion in the preoperative waking state changes to the bite force of the teeth in the upper right zone and the lower right zone exceeding the first bite force, and the bite force of the teeth in the upper left zone and the lower left zone being lower than the first bite force, a prompt instruction is generated that the tooth pad main body 100 has a risk of displacement.

[0091] For example: Under normal circumstances, the bite forces of the teeth in the upper left and lower left areas, and the upper right and lower right areas of the patient are 20kg and 19.8kg respectively. During the operation, the bite forces of the teeth in the upper left and lower left areas are 10kg, and the bite forces of the teeth in the upper right and lower right areas are 25kg. This situation indicates that the force on the tooth pad body 100 is uneven, and the processing module 300 generates a prompt instruction that the tooth pad body 100 has a risk of displacement.

[0092] According to a preferred embodiment, the intelligent anti-bite device can be used in conjunction with an alarm module, wherein the processing module 300 of the intelligent anti-bite device is connected to the alarm module signal, and the alarm module issues an alarm prompt after receiving the prompt instruction of the processing module 300. The adjustment of the electrical stimulation scheme and the abnormal conditions confirmed by the medical staff are stored in a manner associated with the electrical stimulation signal in time, which is conducive to the subsequent analysis and improvement of parameters such as the electrical stimulation interval time and current intensity. Preferably, the alarm prompt can be one or more of a sound prompt, a light prompt, and a vibration prompt. Preferably, the alarm module can be an intelligent electronic device, an alarm, a warning light, etc. For example: when the processing module 300 sends a prompt instruction to the alarm module that the tooth pad has a risk of displacement, the alarm module emits a red light, a voice prompt or a vibration.

[0093] According to a preferred embodiment, the processing module 300 is configured to: when the bite force of the upper teeth and lower teeth at both ends of the patient's mouth corners exceeds the first bite force, the air pressure of the expansion unit 410 corresponding to the upper teeth and lower teeth at both ends of the mouth corners on the tooth pad body 100 is adjusted to the first air pressure to increase the distance between the upper teeth and lower teeth at both ends of the mouth corners, and at the same time output an intraoperative electrical stimulation scheme that reduces the intensity of electrical stimulation. The expansion site and the expansion pressure are measurable and recordable. Based on the expansion information of the tooth pad body 100, the electrical stimulation interval time, and the current intensity that are jointly stored in time association, the R&D personnel can explore new directions or improvement ideas for the anti-bite device to be mass-produced to avoid excessive intensity injuries to the test personnel.

[0094] Assume that the contact area between each airbag and the corresponding tooth is 0.5 cm 2 The bite force of the upper and lower teeth at both ends of the mouth is 28kg, so the first air pressure can be set to 5.6×10 6 pa, 5.7×10 6 pa, 6.×10 6 pa.

[0095] According to a preferred embodiment, the processing module 300 is configured to: when the bite force of the upper teeth and the lower teeth at both ends of the patient's mouth corners exceeds the first bite force, adjust the air pressure of the expansion unit 410 at the middle point between the two ends of the mouth corners on the dental pad body 100 to a second air pressure, wherein the second air pressure is greater than the first air pressure. The second air pressure can be set to 6.5×10 6 pa, 6.7×10 6 pa, 7×10 6 pa.

[0096] According to a preferred embodiment, the processing module 300 is configured as follows: when the fluctuation frequency of the patient's tooth bite force exceeds the first preset frequency and reflects that the patient's masticatory muscle contraction has been enhanced to a certain extent, the air pressure of the expansion unit 410 is increased; when the fluctuation frequency of the patient's tooth bite force exceeds the second preset frequency and reflects that the patient's masticatory muscle contraction is too strong, the air pressure of the expansion unit 410 is increased, and the electric stimulation interval time and / or the current intensity is reduced, wherein the second preset frequency is greater than the first preset frequency. This technical solution provides a basis for exploring feasible design solutions for related products in the future by acquiring data such as the tooth bite force fluctuation frequency, the electric stimulation interval time, and the electric stimulation intensity that are temporally correlated. This avoids unnecessary excessive intensity injuries to testers during the preclinical and clinical trial stages of the product, and can also explore the boundary conditions of a wider range of electric stimulation parameters as much as possible, which is also conducive to enriching treatment plans.

[0097] For example, when the fluctuation frequency of the patient's tooth bite force exceeds the first preset frequency, the first preset frequency is 10 times / min, and the air pressure of the airbag can be set to 6×10 6 pa. The intermittent time of electrical stimulation is increased from 4ms to 6ms. When the fluctuation frequency of the patient's tooth bite force exceeds the first preset frequency, the air pressure of the airbag can be set to 6×10 6 pa, the intermittent time of electrical stimulation is increased from 4ms to 6ms, and the current intensity is reduced from 1500mA to 1200mA. When the fluctuation frequency of the patient's tooth bite force exceeds the first preset frequency, the air pressure of the airbag can be set to 6×10 6 pa, the current intensity is reduced from 1500mA to 1200mA.

[0098] When the fluctuation frequency of the patient's tooth bite force exceeds the second preset frequency, the second preset frequency is 20 times / min, and the air pressure of the airbag can be set to 7×10 6 pa, the intermittent time of electrical stimulation increases from 4ms to 6ms. When the fluctuation frequency of the patient's tooth bite force exceeds the second preset frequency, the air pressure of the airbag can be set to 6.7×10 6 pa, the interval between electrical stimulations increased from 4 ms to 6 ms, and the current intensity decreased from 1500 mA to 1200 mA.

[0099] When the fluctuation frequency of the patient's tooth biting force exceeds the second preset frequency, the air pressure of the airbag can be set to 7×10 6 pa, the current intensity is reduced from 1500mA to 1200mA.

[0100] According to a preferred embodiment, the processing module 300 is configured to: according to the tooth deformity state reflected by the first contour of the occlusal surface 110 of the patient's teeth in the awake state before the operation collected by the monitoring module 200, increase the air pressure of the expansion unit 410 at the position corresponding to the tooth deformity on the tooth pad body 100, so that the deformed teeth can directly contact the occlusal surface 110 of the tooth pad body 100 to ensure the force uniformity of the tooth pad body 100. This technical solution can adapt to different clinical trial subjects or testers, and analyze the tooth deformity state of the tester by collecting occlusal data such as the expansion pressure of the expansion unit 410 and the corresponding expansion position, so as to facilitate R&D personnel to improve the anti-bite device more effectively according to the collected occlusal data. In addition, the acquired occlusal data can also help medical staff explore the boundary conditions of the application of a larger range of stimulation signals in a safer range.

[0101] For example, in the first contour generated by the dental pad body 100, the tooth marks generated in the bitten area of ​​the upper left area are lighter, while those in other areas are darker, indicating that the teeth in the upper left area are deformed. Therefore, the air pressure of the expansion unit 410 corresponding to the position of the dental pad body 100 corresponding to the tooth deformity is increased, and the air pressure can be set to 7.2×10 6 pa、7.5×10 6 pa、7.8×10 6 pa. When the patient is awake, the tooth pad body 100 is placed in the patient's mouth for a bite test, and a contour sample of the occlusal surface 110 of the patient's teeth under normal occlusion is collected. After the tooth pad body 100 is placed in the patient's mouth and neuroelectrophysiological monitoring is implemented, the tooth pad body 100 is pressed by the patient's teeth, and the occlusal data of the tooth pad body 100 (including pressure sites and pressure values) are sent to the processing module 300, which forms a first contour of the occlusal surface 110 of the teeth based on the pressure site distribution data. The processing module 300 compares the first contour with the contour sample of the patient's mouth during the operation to determine whether the tooth pad body 100 is offset. In the case of offset, the processing module 300 sends a prompt message (sound, light, and a combination thereof) to at least one terminal so that medical staff can check or correct the position of the tooth pad body 100 in time, or adjust the shape of the airbag by setting the program of the microprocessor.

[0102] According to a preferred embodiment, the intelligent anti-bite device can be used in conjunction with an external display device, wherein the processing module 300 of the intelligent anti-bite device is connected to the external display device signal, so that the external display device displays the parameters related to the intensity of the electrical stimulation that need to be adjusted after receiving the intraoperative electrical stimulation scheme generated by the processing module 300. Preferably, the external display device can be a display screen, such as a CRT display, an LCD display, an LED display, etc. The signal connection method between the processing module 300 and the external display device is, for example, a WiFi signal, a Bluetooth signal, a radio frequency signal, etc.

[0103] According to a preferred embodiment, the processing module 300 is configured to: when the patient's tooth bite force is less than the first bite force, and the fluctuation frequency is less than the first preset frequency, which reflects that the patient's masticatory muscle contraction has returned to normal, control the micro pump 420 to deflate the expansion unit 410 to reduce the compression time of the expansion unit 410 on the patient's mouth. This technical solution can improve the comfort of clinical trial subjects.

[0104] According to a preferred embodiment, the processing module 300 can also determine whether there is a dental occlusion malocclusion based on the contour sample. In the case of dental occlusion malocclusion, the occlusal surface 110 of the tooth pad body 100 corresponds to the deformed part of the patient's teeth, and there is a sudden change in the pressure value between the deformed part of the teeth and the adjacent normal part. Therefore, the point position and degree of deformation of the patient's teeth can be obtained. The point position and degree of deformation of the teeth can be obtained through the corresponding expansion unit 410 and its expansion pressure, thereby providing an improvement direction for the research and development of related products. It solves the problem in the prior art that when the patient's teeth are deformed, the teeth cannot approach the occlusal surface 110 and form an occlusal obstacle, so that tongue biting may occur.

[0105] The processing module 300 may pre-store several airbag inflation schemes so that the dental pad body 100 can be adaptively adjusted in shape according to the deformed position. Specifically, in the case of missing teeth, the airbags in the area where the missing teeth belong can be filled to a specified height. In the case of overly long teeth, the filling height of the airbags in the area where the long teeth belong can be reduced. By using such an adjustment method, not only the difference in the force on the dental pad between the deformed part and the normal part can be balanced, but the dental pad body 100 will not slip due to uneven force. At the same time, increasing the distance between the upper and lower teeth by inflation can also reduce the probability of tongue biting in the deformed position.

[0106] According to a preferred embodiment, based on the duration of the operation, the processing module 300 can establish a pressure change curve associated with time, and control the micro pump 420 to deflate at a certain frequency when the pressure fluctuation tends to stop or the peak value gradually decreases. This setting reduces the pressure on the tongue by the tooth pad body 100 while ensuring that the patient's tongue is not bitten. This technical solution can analyze, store and utilize the bite force and the stimulation signal in time association, explore the most suitable tooth pad body shape or the intraoperative electrical stimulation scheme matching different tooth pad body shapes based on different electrical stimulation treatment parameters, thereby achieving the purpose of ensuring safety and the best effect of electrical stimulation. Specifically, when the processing module 300 detects that the pressure of the tooth pad body 100 stops changing or has a trend of decreasing, the processing module 300 can control the micro pump 420 of the adjustment module 400 to inflate and deflate at a specified frequency. Preferably, the inflatable and deflated air hole is close to the nasal throat area, or there is a tracheal extension outlet, so that the pressure on the skin areas such as the upper jaw, lower jaw, tongue and cheeks can be relieved, and the bruises formed due to compression can be reduced. For example: some surgeries last more than 4 hours, and too long pressure is not good for the skin in contact with the tooth pad body 100 in the oral cavity, and it is easy to form bruises. Based on the triggering of the bite behavior (i.e., the pressure value monitored by the pressure sensor 130 increases), the micro pump 420 starts to restart and increase the distance between the upper and lower teeth. Based on the cessation of the bite behavior (i.e., the pressure value monitored by the pressure sensor 130 decreases), the micro pump 420 deflates and returns to the specified static state (the static state is, for example, a specified state that has been formed for the deformed occlusion, and the tooth pad body 100 in this state has made adaptive adjustments to the deformed part). In this way, when the tooth pad body 100 just enters the oral cavity and during the operation, it will not form a large pressure on the oral skin, thereby reducing the bruises formed by pressure. The technical solution of this embodiment can adjust the specific shape of the tooth pad body according to the shape change scheme of the tooth pad body, so as to explore some feasible design schemes for the development of related products in the future, so as to achieve the purpose of coexistence of safety and comfort. In addition, the intelligent anti-bite device provided in this embodiment can be used to provide some feasible design schemes for the development of related products, and can also be used for intraoperative treatment.

[0107] Example 2

[0108] This embodiment provides a tooth pad body 100, which is mainly used for collecting bite data in neuroelectrophysiological testing, and for collecting and studying twitch data under MEP stimulation. At the same time, it provides some feasible solutions for improving related products, such as Figure 2As shown. The tooth pad body 100 includes an occlusal surface 110 that is in direct contact with the patient's teeth and an extrusion surface 120 that is in contact with the patient's tongue and cheeks. The occlusal surface 110 and the extrusion surface 120 are preferably connected in an orthogonal form. The occlusal surface 110 includes an upper side surface 111 and a lower side surface 112 that are in contact with the upper teeth and the lower teeth, respectively. The extrusion surface 120 includes an inner side surface 121 and an outer side surface 122 that are in contact with the tongue and the cheeks, respectively. Preferably, the tooth pad body 100 is arranged in an arc shape to conform to the shape of the tooth arrangement. The processing module 300 is arranged in the cavity of the tooth pad body 100. The processing module 300 analyzes the occlusal fluctuation frequency of the patient's teeth according to the changes in the pressure value transmitted by the tooth pad body 100 and the frequency of the changes, and judges the intensity of the electrical stimulation according to the occlusal fluctuation frequency or the pressure value change speed of the tooth pad body 100.

[0109] For the sake of simplicity, the present invention does not provide examples of the appearance shape design of the upper side 111, the lower side 112, the inner side 121 and the outer side 122. The inventor reserves the right to apply for a separate appearance patent for its appearance shape for protection. However, those skilled in the art can imagine that the upper side 111, the lower side 112, the inner side 121 and the outer side 122 can be Figure 4 and Figure 5 The shape of the mouth, teeth and gums of the patient is designed to meet the needs of the shape of the mouth, teeth and gums.

[0110] An adjustment module 400 is arranged in the dental pad body 100. According to a preferred embodiment, the expansion units 410 are arranged in series. The adjustment module 400 can include a plurality of expansion units 410 and a micro pump 420, and the expansion units 410 are preferably arranged as airbags and arranged in series. Preferably, the airbags can be arranged inside the occlusal surface 110 and the extrusion surface 120. Specifically, the first airbag 411 and the second airbag 412 located at the occlusal surface 110 can be multiple in number, and the positions are preferably adapted to the positions of each tooth in the oral cavity of an ordinary person, and the pressure sensor 130 arranged on the occlusal surface 110 is also adapted to the positions of the first airbag 411 and the second airbag 412, that is, each airbag is provided with a pressure sensor 130. The number of the third airbag 413 and the fourth airbag 414 located inside the extrusion surface 120 can be adaptively set to one or more.

[0111] Different airbags have different functions. Specifically, the first airbag 411 and the second airbag 412 can adjust the distance between the upper and lower teeth to prevent the teeth from biting the tongue; and the side of the third airbag 413 facing the tongue (fitted to the inner side surface 121) is easier to expand and deform (for example, using a material with a large expansion coefficient). After the first airbag 411 and the second airbag 412 are inflated, when the tooth pad body 100 is bitten, the upper and lower distances between the first airbag 411 and the second airbag 412 are reduced, and the position of the third airbag 413 facing the tongue side will expand to a certain extent and extend toward the tongue to squeeze the tongue away from the teeth to reduce the probability of biting the tongue.

[0112] The first airbag 411, the second airbag 412, the third airbag 413 and the fourth airbag 414 are connected end to end in sequence to form an expansion unit 410 with a hollow interior. Figure 3 As shown. Preferably, the pressure sensor 130 is respectively arranged on the side of the first airbag 411, the second airbag 412, the third airbag 413 and the fourth airbag 414 facing the inside. Preferably, the pressure sensor 130 is connected to the pressure monitoring unit 210 through a connecting pipeline. Specifically, the first airbag 411 is equipped with a first pressure sensor, the second airbag 412 is equipped with a second pressure sensor, the third airbag 413 is equipped with a third pressure sensor, and the fourth airbag 414 is equipped with a fourth pressure sensor. The first pressure sensor is connected to the pressure monitoring unit 210 through a first connecting pipeline. The second pressure sensor is connected to the pressure monitoring unit 210 through a second connecting pipeline. The third pressure sensor is connected to the pressure monitoring unit 210 through a third connecting pipeline. The fourth pressure sensor is connected to the pressure monitoring unit 210 through a fourth connecting pipeline. Preferably, the pressure monitoring unit 210 is arranged in the middle of the hollow structure formed by the first airbag 411, the second airbag 412, the third airbag 413 and the fourth airbag 414.

[0113] It should be noted that the above-mentioned specific embodiments are exemplary, and those skilled in the art can come up with various solutions inspired by the disclosure of the present invention, and these solutions also belong to the disclosure scope of the present invention and fall within the protection scope of the present invention. Those skilled in the art should understand that the present invention specification and its drawings are illustrative and do not constitute a limitation of the claims. The scope of protection of the present invention is defined by the claims and their equivalents. The present invention specification contains multiple inventive concepts, such as "preferably" and "according to a preferred embodiment", both of which indicate that the corresponding paragraph discloses an independent concept, and the applicant reserves the right to file a divisional application based on each inventive concept. Throughout the text, the features guided by "preferably" are only an optional method and should not be understood as a must-have setting. Therefore, the applicant reserves the right to abandon or delete the relevant preferred features at any time.

Claims

1. Multifunctional oral endotracheal tube fixation and anti-bite device for intraoperative electrophysiology, including: A dental pad body (100) for placement in a patient's oral cavity; A monitoring module (200) disposed on / in the tooth pad body (100) for collecting occlusal data of the patient's teeth, and a processing module (300) connected to the monitoring module (200) by signal, characterized in that: The processing module (300) is configured to: A morphological change scheme and an intraoperative electrical stimulation scheme of the tooth pad body (100) matching the patient's tooth occlusion are generated according to the changes in the pressure sites and the pressure magnitude during the patient's tooth occlusion collected by the monitoring module (200), wherein the intraoperative electrical stimulation scheme includes: when the fluctuation frequency of the tooth occlusion force exceeds the set frequency, increasing the electrical stimulation interval time and / or reducing the current intensity; The anti-bite device further comprises an adjustment module (400) disposed on / in the tooth pad body (100) and connected to the processing module (300) by signal, wherein the adjustment module (400) comprises a plurality of expansion units (410) distributed at different locations of the tooth pad body (100) and a micro pump (420) for providing gas pressure to the expansion units (410). The processing module (300) is configured to: The shape of the expansion unit (410) at different positions of the tooth pad body (100) is controlled according to the generated shape change scheme of the tooth pad body (100), so that the tooth pad body (100) can fit the patient's teeth, thereby reducing the probability of tongue biting and oral bruising.

2. The anti-bite device according to claim 1, characterized in that: The processing module (300) is configured to: When the pressure point and pressure magnitude changes during the patient's tooth occlusion process are manifested as uniform pressure when the upper and lower teeth of each zone are in contact and the first bite force of normal bite in the preoperative conscious state changes to the bite force of the teeth in the upper left zone and the lower left zone exceeding the first bite force, and the bite force of the teeth in the upper right zone and the lower right zone being lower than the first bite force, or the bite force of the teeth in the upper right zone and the lower right zone exceeding the first bite force, and the bite force of the teeth in the upper left zone and the lower left zone being lower than the first bite force, a prompt instruction is generated that the tooth pad body (100) has a risk of displacement.

3. The anti-bite device according to claim 2, characterized in that: The processing module (300) is configured to: When the bite force of the upper teeth and lower teeth at both ends of the patient's mouth corners exceeds the first bite force, the air pressure of the expansion unit (410) at the upper teeth and lower teeth positions corresponding to the upper teeth and lower teeth at both ends of the mouth corners on the tooth pad body (100) is adjusted to the first air pressure to increase the distance between the upper teeth and lower teeth at both ends of the mouth corners, and at the same time, an intraoperative electrical stimulation scheme that reduces the intensity of electrical stimulation is output.

4. The anti-bite device according to claim 3, characterized in that: The adjustment of the intensity of electrical stimulation includes the adjustment of the intermittent time of electrical stimulation and the intensity of current.

5. The anti-bite device according to claim 4, characterized in that: The processing module (300) is configured to: When the bite force of the upper teeth and lower teeth at both ends of the patient's mouth corners exceeds the first bite force, the air pressure of the expansion unit (410) at the middle point between the two ends of the mouth corners on the bite pad body (100) is adjusted to a second air pressure, wherein the second air pressure is greater than the first air pressure.

6. The anti-bite device according to claim 5, characterized in that: The processing module (300) is configured to: When the fluctuation frequency of the patient's tooth biting force exceeds a first preset frequency and reflects that the patient's masticatory muscle contraction is enhanced to a certain extent, increasing the air pressure of the expansion unit (410); When the fluctuation frequency of the patient's tooth biting force exceeds the second preset frequency, which reflects that the patient's masticatory muscles are too strongly contracted, the air pressure of the expansion unit (410) is increased, and the electrical stimulation interval time is increased and / or the current intensity is reduced. Wherein, the second preset frequency is greater than the first preset frequency.

7. The anti-bite device according to claim 1, characterized in that: The tooth pad body (100) comprises an occlusal surface (110) in direct contact with teeth and an extrusion surface (120) in contact with the tongue and cheeks of a patient, wherein the occlusal surface (110) and the extrusion surface (120) are connected in an orthogonal manner.

8. The anti-bite device according to claim 7, characterized in that: The processing module (300) is configured to: According to the tooth deformity state reflected by the first contour of the occlusal surface (110) of the patient's teeth in the awake state before surgery collected by the monitoring module (200), the air pressure of the expansion unit (410) at the location corresponding to the tooth deformity on the tooth pad body (100) is increased so that the deformed tooth can directly contact the occlusal surface (110) of the tooth pad body (100) to ensure the uniformity of force on the tooth pad body (100).

9. The anti-bite device according to claim 8, characterized in that: The processing module (300) is configured to: When the patient's tooth bite force is less than the first bite force and the fluctuation frequency is less than the first preset frequency, reflecting that the patient's masticatory muscle contraction has returned to normal, the micro pump (420) is controlled to deflate the expansion unit (410) to reduce the pressure time of the expansion unit (410) on the patient's mouth.

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