Anesthesia and consciousness depth monitoring system and method

Abstract

The present invention discloses an anesthesia and consciousness depth monitoring system and monitoring method, including an anesthesia depth sensor worn on the head, a cerebral blood oxygen saturation sensor and a main controller connected to the two sensors through a cable, the main controller includes an electroencephalogram signal acquisition module, an infrared light transceiver module, a central processing unit, a display output module and a user input module, the central processing unit is used to send a synchronization instruction acquisition signal to the electroencephalogram signal acquisition module and the infrared light transceiver module, receive the electroencephalogram acquisition data processed by the electroencephalogram signal acquisition module and the cerebral blood oxygen acquisition data processed by the infrared light transceiver module, the central processing unit performs synchronous data processing on the electroencephalogram acquisition data and the cerebral blood oxygen acquisition data, obtains electroencephalogram and cerebral blood oxygen saturation synchronization data, and displays a numerical value or trend curve on the display output module. The present invention synchronizes electroencephalogram and cerebral blood oxygen acquisition, and truly realizes synchronous acquisition, analysis and real-time extraction of related indicators.

Description

Technical Field

[0001] The present invention relates to the technical field of anesthesia depth monitoring, and in particular to an anesthesia and consciousness depth monitoring system and method. Background Art

[0002] Anesthesia depth monitoring has always been a concern for anesthesiologists. Anesthesia depth depends on the balance between two antagonistic factors: anesthetic dose and surgical stimulation. Optimal anesthesia depth requires a sufficient amount of anesthetic to maintain unconsciousness without affecting the function of vital organs. The depth level of general anesthesia needs to be suitable for individual patients undergoing surgery. If anesthesia is deeper than the depth required to keep the patient unconscious, anesthesia-related complications may increase, such as postoperative nausea, vomiting, and cognitive dysfunction. If the depth of anesthesia is too shallow, the patient may not completely lose consciousness, and there is a risk of intraoperative awareness. Therefore, optimal dosing and precise administration are essential to achieve ideal and effective analgesia, unconsciousness, and immobility to reduce the potential negative effects of underdosing or overdosing.

[0003] In the past, anesthesiologists mainly judged the depth of anesthesia and adjusted the anesthetic medication by observing clinical signs such as blood pressure, heart rate, respiration, sweating, pupil reflex, pulse oxygen saturation, tearing, eye movement, facial expression, etc. However, the use of drugs such as muscle relaxants and vasodilators makes the analysis of these signs difficult and unreliable, and the depth of anesthesia cannot be fully grasped through simple clinical observation.

[0004] Accurately monitoring the depth of anesthesia will help improve the safety and quality of anesthesia, protect the life and recovery of patients, and provide patients with a better experience. With the advancement of physics, biology, and computer technology in recent years, the systematic monitoring of the depth of anesthesia has undergone extensive research and attempts. At present, derived indicators generated by electroencephalograms, such as bispectral index, entropy, auditory evoked potentials, etc., have gradually been widely used in clinical practice.

[0005] Electroencephalogram (EEG) is the most common non-invasive signal that reflects neural communication and status. It measures and describes the spontaneous or induced rhythmic bioelectric activity of the frontal cortex through a sensor placed on the patient's forehead to monitor the depth of unconsciousness. The EEG waveform in the awake state is a low-amplitude, high-frequency signal. General anesthetics can cause changes in EEG frequency and waveform and burst inhibition, turning it into a high-amplitude, low-frequency signal. These are related to the type of anesthetic drugs and have different characteristics at different stages of anesthesia.

[0006] The anesthesia depth monitoring technology based on EEG signals mainly monitors the changes in the sedation component of anesthesia, and is not sensitive to the analgesic component of anesthesia. Therefore, the clinical value of using the parameters in EEG signals for anesthesia depth monitoring is closely related to the anesthesia method and anesthetic medication. Other disadvantages include the hysteresis phenomenon in monitoring the level of consciousness, relatively low sensitivity, and is not suitable for newborns, patients with neurological diseases, and patients taking psychoactive drugs. Technologies for anesthesia depth monitoring based on EEG signals, such as BIS, entropy, AEP and other indicators, have been widely recognized in the clinic. Among them, BIS technology is particularly common in clinical use. However, since BIS and other EEG indicators are mainly used to analyze the patient's sedation indicators, the data has a large range of variation, and in order to avoid intraoperative awareness, the clinic will try to put the patient into a deeper sedation state. This can easily lead to overdose of anesthesia, causing ischemia and hypoxia in the patient's brain, which in turn leads to symptoms such as delirium in postoperative patients. However, the brain tissue, which accounts for only 2% of the body weight, consumes 20% of the oxygen inhaled by the human body and is extremely sensitive to hypoxia. Once cerebral ischemia and hypoxia occur, it is easy to cause perioperative neurological complications. Therefore, there is an urgent need for real-time monitoring of brain tissue blood supply and oxygen supply in the clinic. Cerebral blood oxygen monitoring technology is a non-invasive method for detecting brain tissue blood oxygen saturation. It can evaluate the patient's brain tissue blood oxygen status in real time. Once the blood oxygen decreases, it will alarm, thereby avoiding the occurrence of cerebral ischemia and hypoxia. Therefore, if anesthesia depth monitoring can be combined with cerebral blood oxygen detection technology, it can well achieve the safety and effectiveness of the anesthesia process and avoid the possibility of perioperative nervous system damage.

[0007] With the development of optical technology, light and photoelectric technology have been effectively and widely used in various fields due to their bio-effectiveness advantages. Using near infrared spectroscopy (NIRS), the blood supply and oxygen supply to the brain can be non-invasively detected based on the absorption characteristics of hemoglobin in a specific band. This technology has been developed in Japan, the United States, and the United Kingdom and has achieved a lot of results. This is a very meaningful attempt to apply advanced photoelectric technology to medical research. By using near infrared light to pass through the superficial tissue of the head, brain tissue blood oxygen saturation can be detected, and then real-time non-invasive monitoring of brain tissue blood oxygen perfusion can be performed. At present, there are mainly Fore-Sight equipment developed by CASMED in the United States, NIR500 of Hamamatsu Company in Japan, and INVOS7100 produced by Medtronic in the United States. These devices all achieve brain tissue blood oxygen saturation monitoring by arranging two photoelectrode probes on the forehead. The representative one in China is the near infrared tissue blood oxygen parameter monitor developed by Tsinghua University, which is mainly used in brain oxygen research, tissue blood oxygen monitoring, and sports medicine testing. The Zhongke Borui team from the Chinese Academy of Sciences has developed a brain blood oxygen monitor and a brain blood oxygen headband, which can achieve real-time monitoring of brain blood oxygen, tissue blood oxygen, and finger pulse blood oxygen. For brain blood oxygen detection, the above technologies and systems are all tested by arranging a probe on each side of the forehead.

[0008] With the promotion of these products, related technologies have gradually been applied to the clinical frontline, bringing hope to stroke detection and bedside monitoring. Cerebral blood oxygen saturation is an objective evaluation indicator of cerebral perfusion and cerebral oxygenation. At present, near-infrared brain oxygen detection has been effectively used in neurosurgery, cardiovascular surgery, emergency and critical care rescue, extracorporeal circulation, cardiopulmonary resuscitation after cardiac arrest and other treatments. In general anesthesia, if there is a lack of monitoring means for brain tissue oxygen supply, it may cause damage to or even loss of brain tissue neurological function. Therefore, clinical, especially intraoperative cerebral blood oxygen detection is very necessary. Real-time, continuous, and non-invasive detection of brain oxygen supply can effectively reduce the damage of patients' brain tissue, optimize perioperative management, improve postoperative cognitive ability, and improve patient prognosis. These clinical values ​​have been clearly reflected in professional guidelines such as the "Guidelines for Clinical Anesthesia Monitoring 2017 Edition", "Chinese Multidisciplinary Expert Consensus on Perioperative Brain Health in Elderly Patients", and "Chinese Expert Consensus on Perioperative Brain Protection in Cardiac Surgery".

[0009] The combination of these two methods cannot simply be achieved by having two systems independently collect signals and then have anesthesiologists make judgments. On the one hand, since they are two different systems, their respective times are independent of each other, which will cause the monitored values ​​to not necessarily be the status of the patient at the same time point. In addition, since they are independent systems, it is not convenient for medical workers to combine the data of the two systems for long-term correlation analysis. In addition, another inconvenience is that it is difficult to combine these two indicators for real-time joint analysis.

[0010] Chinese patent document CN 108113668 discloses an integrated anesthesia depth and cerebral blood oxygen saturation detection sensor, which fixes the anesthesia depth sensor and the cerebral blood oxygen saturation sensor on a strap respectively. Although it solves the problem of sequential detection of the two systems and realizes the ability to simultaneously measure the anesthesia depth and cerebral blood oxygen saturation with one detection sensor, it simply integrates the two sensors together for detection, which only improves the convenience of detection, and does not realize multi-parameter synchronization, joint analysis and real-time extraction of indicators in data processing. Summary of the invention

[0011] The purpose of the present invention is to solve the problem of multi-parameter joint analysis of EEG signals and brain tissue blood oxygen saturation detection in the prior art, and truly realize synchronous collection, analysis and real-time extraction of related indicators. To this end, the present invention provides an anesthesia and consciousness depth monitoring system and method.

[0012] The present invention adopts the following technical solution:

[0013] In one aspect, the present invention provides an anesthesia and consciousness depth monitoring system, comprising a flexible substrate and an anesthesia depth sensor and a cerebral blood oxygen saturation sensor fixed on the flexible substrate, the system further comprising a main controller connected to the anesthesia depth sensor and the cerebral blood oxygen saturation sensor via a cable, the main controller comprising:

[0014] An electroencephalogram signal acquisition module, connected to the anesthesia depth sensor, for transmitting an instruction acquisition signal to the anesthesia depth sensor and receiving the electroencephalogram signal acquired by the anesthesia depth sensor;

[0015] an infrared light transceiver module, connected to the cerebral blood oxygen saturation sensor, for transmitting a command acquisition signal to the cerebral blood oxygen saturation sensor and receiving a cerebral blood oxygen signal acquired by the cerebral blood oxygen saturation sensor;

[0016] A central processing unit is used to send a synchronization command acquisition signal to the EEG signal acquisition module and the infrared light transceiver module, receive the EEG acquisition data processed by the EEG signal acquisition module and the cerebral blood oxygen acquisition data processed by the infrared light transceiver module, and the central processing unit performs synchronous data processing on the EEG acquisition data and the cerebral blood oxygen acquisition data to obtain the currently acquired EEG and cerebral blood oxygen saturation synchronous data;

[0017] A display output module, used to display the values ​​and / or trend curves of EEG data and cerebral blood oxygen saturation data;

[0018] The user input module is used to input the monitoring information of EEG and cerebral blood oxygen into the central processing unit.

[0019] The central processing unit includes:

[0020] An EEG data processing module performs data analysis on the received EEG data to obtain the currently collected EEG data;

[0021] The cerebral blood oxygen saturation data processing module performs data analysis on the received cerebral blood oxygen collection data to obtain the currently collected cerebral blood oxygen saturation data.

[0022] Furthermore, the central processing unit also includes a joint data analysis module, which performs joint data analysis on the EEG data and cerebral blood oxygen saturation data obtained at the same time point to obtain a neurovascular coupling index (Neuro-Vascular Coupling Index, NVCI), and its calculation formula is as follows:

[0023] NVCI=f(α*BIS+β*rSo2)

[0024] Where: BIS is the Bispectral Index (BIS);

[0025] rSo2 is the cerebral blood oxygen saturation value;

[0026] α and β are weight coefficients.

[0027] The anesthesia depth sensor includes a first measuring electrode and a second measuring electrode for detecting the outer EEG signal above the left and right eyebrows of the forehead, a third measuring electrode and a fourth measuring electrode for detecting the inner EEG signal above the left and right eyebrows of the forehead, a ground electrode located between the third measuring electrode and the fourth measuring electrode, and a first reference electrode and a second reference electrode for detecting the position of the left and right temples of the forehead;

[0028] The cerebral blood oxygen saturation sensor includes a left cerebral blood oxygen saturation acquisition group for detecting the left side of the forehead and a right cerebral blood oxygen saturation acquisition group for detecting the right side of the forehead;

[0029] The left cerebral blood oxygen saturation acquisition group includes a first light source, a first phototube and a second phototube, and the right cerebral blood oxygen saturation acquisition group includes a second light source, a third phototube and a fourth phototube; the first light source is arranged between the third measuring electrode and the ground electrode, the second light source is arranged between the fourth measuring electrode and the ground electrode, the first phototube and the second phototube are arranged at intervals between the first measuring electrode and the third measuring electrode, and the third phototube and the fourth phototube are arranged at intervals between the second measuring electrode and the fourth measuring electrode.

[0030] Furthermore, the central processing unit performs joint data analysis by combining the EEG data and cerebral blood oxygen saturation data of the left and right sides of the forehead obtained at the same time point through the joint data analysis module to obtain the NVCI of the forehead, and the calculation formula is as follows:

[0031] NVCI=f(α1*lBIS+α2*rBIS+β1*lrSO2+β2*rrSO2)

[0032] Where: lBIS——Bispectral Index (BIS) of left side EEG;

[0033] rBIS——right bispectral index (BIS);

[0034] lrSO2 – left cerebral blood oxygen saturation;

[0035] rrSO2—right cerebral oxygen saturation;

[0036] The weight coefficients α1, β1, α2, β2 in the above formula are obtained by weighting method, voting method or random forest method in artificial intelligence algorithm.

[0037] Preferably, an alarm unit is provided in the main controller, and a discrimination module is provided in the central processing unit. The EEG data threshold, cerebral blood oxygen threshold and NVCI threshold are set in the discrimination module. According to the set threshold, a judgment is made as to whether the calculated data in the EEG data processing module, the cerebral blood oxygen saturation data processing module and the joint data analysis module exceeds the set corresponding parameter threshold. If the set corresponding parameter threshold is exceeded, the alarm unit sends a warning signal to the outside.

[0038] The main controller is also provided with a data storage module and a data output module. The data storage module is used to receive the processed data from the EEG data processing module, the cerebral blood oxygen saturation data processing module and the joint data analysis module in real time; the data output module is used to output the EEG data and the cerebral blood oxygen saturation data.

[0039] On the other hand, the present invention also provides a method for anesthesia and depth of consciousness monitoring, the method comprising the following steps:

[0040] Step 1, attaching a flexible substrate with an anesthesia depth sensor and a cerebral blood oxygen saturation sensor to the forehead of a patient;

[0041] Step 2, connecting the main controller to the anesthesia depth sensor and the cerebral blood oxygen saturation sensor respectively through cables;

[0042] Step 3, the main controller sends a synchronization command acquisition signal to the anesthesia depth sensor and the cerebral blood oxygen saturation sensor, and the anesthesia depth sensor and the cerebral blood oxygen saturation sensor synchronously collect the EEG signal and the cerebral blood oxygen signal at the frontal brain area, collect the EEG signal and the cerebral blood oxygen signal of the frontal brain area, and transmit them to the main controller;

[0043] Step 4: The main controller performs synchronous data processing to obtain current EEG data and cerebral blood oxygen saturation data, and displays real-time synchronous data and / or synchronous curves of the EEG data and cerebral blood oxygen saturation.

[0044] The anesthesia depth sensor in step 1 performs synchronous detection of EEG signals and EOG signals on the left temple area, the right temple area, the left brow area, and the right brow area on both sides of the patient's forehead; the cerebral blood oxygen saturation sensor performs synchronous detection of cerebral blood oxygen signals on both sides of the patient's forehead.

[0045] The method for achieving synchronous acquisition of EEG acquisition signals and cerebral blood oxygen saturation signals in step 3 is to control the cerebral blood oxygen acquisition frequency to be consistent with the EEG acquisition frequency in the main controller, and the main controller synchronously sends the command acquisition signal to the anesthesia depth sensor and the cerebral blood oxygen saturation sensor.

[0046] The method for achieving synchronous acquisition of the EEG acquisition signal and the cerebral blood oxygen saturation signal in step 3 is that the main controller sends command acquisition signals to the anesthesia depth sensor and the cerebral blood oxygen saturation sensor respectively, and controls the EEG signal acquisition time point of the anesthesia depth sensor to be synchronized with the cerebral blood oxygen saturation sensor.

[0047] The method also includes a joint analysis step 5 of brain data in the forehead area, which performs a joint analysis on the EEG, EOG data and cerebral blood oxygen saturation data on the left and right sides of the forehead obtained in step 4 to obtain NVCI in the forehead area and display the value and / or trend curve.

[0048] The method further includes an early warning step 6, in which thresholds are set in the main controller for the EEG data, cerebral blood oxygen saturation data and NVCI on both sides of the forehead, and when the EEG data, cerebral blood oxygen saturation data and NVCI at each position obtained in step 5 are greater than the set corresponding thresholds, the main controller sends a warning signal to the outside.

[0049] The technical solution of the present invention has the following advantages:

[0050] A. During detection, the present invention attaches a flexible substrate with an anesthesia depth sensor and a cerebral blood oxygen saturation sensor to the forehead of the patient. The central processing unit in the main controller sends a synchronization instruction acquisition signal to the EEG signal acquisition module and the infrared light transceiver module to synchronously control the detection time of the anesthesia depth sensor and the cerebral blood oxygen saturation sensor, which can achieve synchronous and real-time acquisition of key brain tissue information such as EEG and cerebral blood oxygen. The cerebral blood oxygen acquisition frequency can be controlled to be consistent with the EEG acquisition frequency or the time points of the EEG and cerebral blood oxygen acquisition signals can be synchronized, which can be accurately completed under the same time control, and the synchronous reading of these two key brain information under the same system time can be achieved. When used, it can enable medical staff to accurately judge the patient's anesthesia and consciousness depth state, avoid the harm to the patient caused by excessive anesthesia, and solve the problem of detection asynchrony caused by the inconsistency between the time scale of the EEG signal and the time scale of the cerebral blood oxygen change.

[0051] B. After synchronously collecting the EEG and EOG signals on the left and right sides of the forehead, the present invention can be combined with the cerebral blood oxygen signal of this part for analysis. EEG signals and cerebral blood oxygen signals correspond to signals generated by neuronal discharge and signals generated by local blood oxygen metabolism in the brain, respectively, which need to play different roles in clinical applications of anesthesia or discrimination of consciousness levels. The present invention jointly analyzes these two or more brain signals. The joint analysis method adopts a simple weighting method, a voting method, or a random forest method in an artificial intelligence algorithm, etc., and gives different weights to the EEG data and cerebral blood oxygen saturation data of different brains, so that they play different roles in different clinical applications, so as to meet the needs of clinical precision treatment. The present invention can generate new brain indicators for comprehensive discrimination by jointly analyzing the parameters from a variety of brain signals, such as the Neuro-Vascular Coupling Index (NVCI), which can be used to comprehensively analyze and monitor patients in anesthesia.

[0052] C. Based on the joint analysis of multiple brain parameters, the present invention can realize the real-time output of data indicators obtained by combining multiple parameters. By combining the BIS signal obtained by EEG, the rSO2 signal obtained by cerebral blood oxygen collection, and the NVCI signal obtained after the joint analysis of multiple parameters, the real-time output and display of multiple parameters and joint indicators can be realized, and the above parameters are displayed on the same interface, which is very convenient for medical workers to interpret. At the same time, by setting an alarm unit in the main controller, when a certain parameter exceeds the set threshold, medical workers can be reminded to be vigilant through warning signals such as sound or light, so that the displayed data has more reference value and the interpretation accuracy is higher. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] In order to more clearly illustrate the specific embodiments of the present invention, the drawings required for use in the specific embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0054] Figure 1 It is a schematic diagram of system acquisition provided by the present invention;

[0055] Figure 2 yes Figure 1 The internal structure diagram of the main controller;

[0056] Figure 3 yes Figure 1 Schematic diagram of sensor arrangement;

[0057] Figure 4 yes Figure 1 The display output module of the main controller provides an external display interface.

[0058] The following are marked in the figure:

[0059] 1-first measuring electrode; 2-second measuring electrode; 3-third measuring electrode; 4-fourth measuring electrode; 5-ground electrode; 6-first light source; 7-first phototube; 8-second phototube; 9-second light source; 10-third phototube; 20-fourth phototube; 30-main controller; 40-cable; 50-plug; 60-flexible substrate; 70-probe; 80-first reference electrode; 90-second reference electrode; a-left cerebral blood oxygen saturation acquisition group; b-right cerebral blood oxygen saturation acquisition group. DETAILED DESCRIPTION

[0060] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0061] like Figure 1 , Figure 2 and Figure 3 As shown, the present invention provides an anesthesia and consciousness depth monitoring system, including a flexible substrate 60 and an anesthesia depth sensor and a cerebral blood oxygen saturation sensor fixed on the flexible substrate 60, and the system also includes a main controller 30 connected to the anesthesia depth sensor and the cerebral blood oxygen saturation sensor through a cable. The main controller 30 is as shown in FIG. Figure 2 As shown, including:

[0062] The EEG signal acquisition module is connected to the anesthesia depth sensor and is used to transmit the command acquisition signal to the anesthesia depth sensor and receive the EEG signal acquired by the anesthesia depth sensor;

[0063] An infrared light transceiver module is connected to the cerebral blood oxygen saturation sensor and is used to transmit command collection signals to the cerebral blood oxygen saturation sensor and receive cerebral blood oxygen signals collected by the cerebral blood oxygen saturation sensor;

[0064] The central processing unit is used to send synchronization command acquisition signals to the EEG signal acquisition module and the infrared light transceiver module, receive the EEG acquisition data processed by the EEG signal acquisition module and the cerebral blood oxygen acquisition data processed by the infrared light transceiver module, and the central processing unit performs synchronous data processing on the EEG acquisition data and the cerebral blood oxygen acquisition data to obtain the currently acquired EEG and cerebral blood oxygen saturation synchronous data;

[0065] A display output module, used to display the values ​​and / or trend curves of EEG data and cerebral blood oxygen saturation data;

[0066] A user input module, used to input monitoring information for EEG and cerebral blood oxygen into the central processing unit;

[0067] The power management module is used to manage the power supply to each module.

[0068] The central processing unit includes:

[0069] An EEG data processing module performs data analysis on the received EEG data to obtain the currently collected EEG data;

[0070] A cerebral blood oxygen saturation data processing module performs data analysis on the received cerebral blood oxygen collection data to obtain the currently collected cerebral blood oxygen saturation data;

[0071] The joint data analysis module combines the EEG data and cerebral oxygen saturation data obtained at the same time point for joint data analysis to obtain the Neuro-Vascular Coupling Index (NVCI), which is calculated as follows:

[0072] NVCI=f(α*BIS+β*rSo2)

[0073] Where: BIS is the Bispectral Index (BIS);

[0074] rSo2 is the cerebral blood oxygen saturation value;

[0075] α and β are weight coefficients.

[0076] Combination Figure 3 The structure of the probe 70 attached to the patient's forehead is described in detail. The anesthesia depth sensor arranged on the flexible substrate 60 includes a first measuring electrode 1 and a second measuring electrode 2 for detecting the outer EEG signal above the brow bone on the left and right sides of the forehead, a third measuring electrode 3 and a fourth measuring electrode 4 for detecting the inner EEG signal above the brow bone on the left and right sides of the forehead, a grounding electrode 5 located between the third measuring electrode 3 and the fourth measuring electrode 4, and a first reference electrode 80 and a second reference electrode 90 for detecting the EEG signal at the temple position on the left and right sides of the forehead; the cerebral blood oxygen saturation sensor on the flexible substrate 60 includes a left cerebral blood oxygen saturation acquisition group a for detecting the left side of the forehead and a right cerebral blood oxygen saturation acquisition group b for detecting the right side of the forehead; wherein the left cerebral blood oxygen saturation acquisition group a includes a first light source 6, a first phototube 7 and a second phototube 8, and the right cerebral blood oxygen saturation acquisition group b includes a second light source 9, a third phototube 10 and a fourth phototube 20; the first light source 6 is arranged between the third measuring electrode 3 and the reference electrode 5, the second light source 9 is arranged between the fourth measuring electrode 4 and the reference electrode 5, and the first phototube 7 and the second phototube 8 are arranged at intervals between the first measuring electrode 1 The third photoelectric tube 10 and the fourth photoelectric tube 20 are arranged between the second measuring electrode 2 and the fourth measuring electrode 4. The anesthesia depth sensor formed by the above-mentioned electrodes and the cerebral blood oxygen saturation acquisition group formed by the light sources and the photoelectric tubes can all adopt the existing technology, and their structural principles will not be repeated here.

[0077] In order to facilitate the collection of EEG signals and cerebral blood oxygen signals, the present invention designs two sets of sensors in the probe, which can respectively collect EEG signals and cerebral blood oxygen signals of the left and right cerebral hemispheres.

[0078] The first measuring electrode 1, the third measuring electrode 3 and the reference electrode 5 can form a combination to collect the BIS signal of the left cerebral hemisphere. The second measuring electrode 2, the fourth measuring electrode 4 and the reference electrode 5 form another combination to collect the BIS signal of the right cerebral hemisphere. Therefore, a total of five electrodes constitute the sensor for collecting EEG in the probe.

[0079] The collection of brain blood oxygen signal consists of a light source and a photoelectric tube in the probe. Similarly, for the left and right brain blood oxygen, the present invention arranges two sets of brain blood oxygen collection sensors. The function of the light source is to emit red light and infrared light into the skull, and the function of the photoelectric tube is to receive the red light and infrared light emitted from the scalp and convert them into electrical signals. Both the electrical signals of EEG and the electrical signals of brain blood oxygen are transmitted to the main controller through cables.

[0080] The main controller 30 of the present invention is also provided with a data storage module and a data output module. The data storage module is used to receive the processed data in the EEG data processing module, the cerebral blood oxygen saturation data processing module and the joint data analysis module in real time; the data output module is used to output the EEG data and the cerebral blood oxygen saturation data.

[0081] like Figure 1 As shown, in specific use, the probe 70 is first attached to the patient's forehead, and the probe 70 is connected to the main controller 30 through a cable 40 and a plug 50. The main controller here has input, display and other functions, and displays and stores the data obtained by monitoring.

[0082] The main functional modules of the main controller 30 are as follows: Figure 2 shown.

[0083] After the anesthesia depth sensor in the probe transmits the EEG signal back, it is processed by the EEG signal acquisition module in the main controller. The main functions of the EEG signal acquisition module include signal amplification, signal conditioning, analog-to-digital conversion and data transmission. The processed EEG signal is sent to the central processing unit, and the set algorithm in the EEG data processing module can be used for filtering, feature extraction, parameter calculation, etc. The BIS data obtained by EEG signal processing will enter the cache, and the calculated data related to the EEG signal will be displayed in the output module and stored in the data storage module. It can also be sent through the data output module, for example, transmitted to a mobile terminal via wireless or wired transmission.

[0084] For the collection of brain blood oxygen signal, first, the infrared light transceiver module in the main controller sends an electrical signal to the probe, driving the light source in the probe to emit infrared light and red light into the scalp. After passing through the scalp, skull, cerebrospinal fluid and other tissues, the light signal enters the brain tissue. In the brain tissue, oxygenated hemoglobin and deoxygenated hemoglobin absorb light to varying degrees. The remaining light then passes through the cerebrospinal fluid, skull and scalp in reverse order and then emerges. The emitted light will be received by the photoelectric tube. The main function of the photoelectric tube is to complete the photoelectric conversion. The converted electrical signal is then sent by the probe to the infrared light transceiver module of the main controller, which is amplified, converted into analog and digital, and sent as data. The processed signal is sent to the central processing unit. In the central processing unit, the cerebral blood oxygen saturation data processing module performs signal filtering, cerebral blood oxygen saturation calculation, etc. to obtain cerebral blood oxygen saturation data. The cerebral blood oxygen saturation data will enter the cache. At the same time, the cerebral blood oxygen data will be displayed in the display output module and stored in the data storage module. It can also be sent through the data output module, for example, transmitted to a mobile terminal via wireless or wired transmission.

[0085] In the process of collecting EEG and cerebral blood oxygen data, since the time scale of EEG signals is in milliseconds, and the time scale of cerebral blood oxygen is in seconds, the present invention ensures that these two signals can be collected synchronously. The central processing unit will send a synchronous collection signal to the EEG signal collection module and the infrared light transceiver module, and the synchronous collection of these two brain signals is achieved through this synchronization signal. Specifically, during collection, signal synchronization can be achieved by increasing the cerebral blood oxygen collection frequency to be consistent with the EEG collection frequency. It is also possible for the central processing unit to send its own collection signal to each sensor, and only synchronize at the time point of cerebral blood oxygen collection. This method can reduce the collection of redundant cerebral blood oxygen data. Reference Figure 2 As shown, the central processing unit determines the synchronization time point according to the clock signal and system settings. When the synchronization time point signal arrives, the output of the synchronization signal is triggered, and the synchronization signal is sent to the EEG signal acquisition module and the infrared light transceiver module to control the analog-to-digital conversion or synchronous output in the two modules, so that the EEG signal acquisition module and the infrared light transceiver module simultaneously obtain the digital signal at the time point, and finally realize the synchronization of multiple signals in the two modules under the same system.

[0086] After obtaining the BIS data of EEG and the blood oxygen saturation data of cerebral blood oxygen, the data joint analysis method can be started in the central processing unit. The calculation formula used is as follows:

[0087] NVCI=f(α1*lBIS+α2*rBIS+β1*lrSO2+β2*rrSO2)

[0088] The new NVCI can be obtained by the above equation. The specific implementation process is as follows: After the central processing unit receives the EEG signal collected by the EEG signal acquisition module, data filtering, feature extraction, etc. are performed, and the left BIS (lBIS) and the right BIS (rBIS) are calculated. At the same time, the signal from the infrared light transceiver module is obtained, and the left cerebral blood oxygen saturation (lrSO2) and the right cerebral blood oxygen saturation (rrSO2) are obtained by the algorithm. Each weight value can be determined by the training set data, and the new parameter NVCI value can be obtained by the above formula. The above function comprehensively considers the left BIS (lBIS), the right BIS (rBIS), the left cerebral blood oxygen saturation (lrSO2) and the right cerebral blood oxygen saturation (rrSO2). There are many ways to obtain new parameters by combining multiple parameters, that is, f can have many functional forms, and the simplest one is to use the weighted summation method. It is also possible to use artificial intelligence methods to determine f, preferably the random forest method.

[0089] The random forest method is a relatively new machine learning model. The classic machine learning model is the neural network, which has a history of more than half a century and will not be described in detail here.

[0090] In the present invention, when the random forest method is used, by establishing decision trees for left BIS (lBIS), right BIS (rBIS), left cerebral blood oxygen saturation (lrSO2) and right cerebral blood oxygen saturation (rrSO2), each weight value is determined by the training set data. Once the decision tree and the weight of each decision tree are determined, the function f is also determined. When new data is input, the NVCI result can be determined according to this random forest.

[0091] In order to remind medical staff to pay attention to the patient's condition, the present invention also has an alarm unit in the main controller, and a discrimination module in the central processing unit. The EEG data threshold, cerebral blood oxygen threshold and NVCI threshold are set in the discrimination module. After obtaining the EEG, cerebral blood oxygen saturation values ​​and NVCI values, the central processing unit will make a judgment based on the set threshold. If the value exceeds the threshold, the alarm unit in the main controller will be activated to alarm. The warning signal will be issued in various ways such as sound and light flashing.

[0092] like Figure 4 As shown in the figure, after all the data is obtained, the data will be displayed through the display interface on the main controller. The display interface can present different display modes for the data. The most typical display mode is as follows: Figure 4As shown, the BIS and cerebral oxygen saturation rSO2 of the left frontal brain area, the BIS and cerebral oxygen saturation rSO2 of the right frontal brain area, and the NVCI value are displayed respectively. In the display interface, the curve on the left corresponds to the trend curve of each parameter, and the current value of each parameter is displayed on the right. The trend curve can clearly show the changes in each brain parameter, accurately know the anesthesia and consciousness depth of the patient, and avoid the negative effects of excessive anesthesia. When the displayed value exceeds the corresponding threshold set, an alarm is issued to remind the monitoring personnel, which is very beneficial for intraoperative monitoring of the patient.

[0093] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. However, the obvious changes or modifications derived therefrom are still within the scope of protection of the present invention.

Claims

1. An anesthesia and consciousness depth monitoring system, comprising a flexible substrate and an anesthesia depth sensor and a cerebral blood oxygen saturation sensor fixed on the flexible substrate, characterized in that: The system further includes a main controller connected to the anesthesia depth sensor and the cerebral blood oxygen saturation sensor via a cable, and the main controller includes: An electroencephalogram signal acquisition module, connected to the anesthesia depth sensor, for transmitting an instruction acquisition signal to the anesthesia depth sensor and receiving the electroencephalogram signal acquired by the anesthesia depth sensor; an infrared light transceiver module, connected to the cerebral blood oxygen saturation sensor, for transmitting a command acquisition signal to the cerebral blood oxygen saturation sensor and receiving a cerebral blood oxygen signal acquired by the cerebral blood oxygen saturation sensor; A central processing unit is used to send a synchronization command acquisition signal to the EEG signal acquisition module and the infrared light transceiver module, receive the EEG acquisition data processed by the EEG signal acquisition module and the cerebral blood oxygen acquisition data processed by the infrared light transceiver module, and the central processing unit performs synchronous data processing on the EEG acquisition data and the cerebral blood oxygen acquisition data to obtain the currently acquired EEG and cerebral blood oxygen saturation synchronous data; A display output module, used to display the values ​​and / or trend curves of EEG data and cerebral blood oxygen saturation data; A user input module, used to input monitoring information for EEG and cerebral blood oxygen into the central processing unit; The central processing unit also includes a joint data analysis module, which combines the EEG data and the cerebral blood oxygen saturation data obtained at the same time point for joint data analysis to obtain the Neuro-Vascular Coupling Index (NVCI), which is calculated as follows: NVCI=f(α*BIS+β*rSo2) Where: BIS is the Bispectral Index (BIS); rSo2 is the cerebral blood oxygen saturation value; α and β are weight coefficients.

2. The anesthesia and consciousness depth monitoring system according to claim 1, characterized in that: The central processing unit comprises: An EEG data processing module performs data analysis on the received EEG data to obtain the currently collected EEG data; The cerebral blood oxygen saturation data processing module performs data analysis on the received cerebral blood oxygen collection data to obtain the currently collected cerebral blood oxygen saturation data.

3. The anesthesia and consciousness depth monitoring system according to claim 1, characterized in that: The anesthesia depth sensor includes a first measuring electrode and a second measuring electrode for detecting the outer EEG signal above the left and right eyebrows of the forehead, a third measuring electrode and a fourth measuring electrode for detecting the inner EEG signal above the left and right eyebrows of the forehead, a ground electrode located between the third measuring electrode and the fourth measuring electrode, and a first reference electrode and a second reference electrode for detecting the position of the left and right temples of the forehead; The cerebral blood oxygen saturation sensor includes a left cerebral blood oxygen saturation acquisition group for detecting the left side of the forehead and a right cerebral blood oxygen saturation acquisition group for detecting the right side of the forehead; The left cerebral blood oxygen saturation acquisition group includes a first light source, a first phototube and a second phototube, and the right cerebral blood oxygen saturation acquisition group includes a second light source, a third phototube and a fourth phototube; the first light source is arranged between the third measuring electrode and the ground electrode, the second light source is arranged between the fourth measuring electrode and the ground electrode, the first phototube and the second phototube are arranged at intervals between the first measuring electrode and the third measuring electrode, and the third phototube and the fourth phototube are arranged at intervals between the second measuring electrode and the fourth measuring electrode.

4. The anesthesia and consciousness depth monitoring system according to claim 3, characterized in that: The central processing unit performs joint data analysis by combining the EEG data and cerebral blood oxygen saturation data of the left and right sides of the forehead obtained at the same time point through the joint data analysis module to obtain the NVCI of the forehead, and the calculation formula is as follows: ； Where: —— Bispectral Index (BIS) on the left side; —— Bispectral Index (BIS) on the right side; ——Left cerebral blood oxygen saturation; ——Right cerebral oxygen saturation; The weight coefficients α1, β1, α2, β2 in the above formula are obtained by weighting method, voting method or random forest method in artificial intelligence algorithm.

5. The anesthesia and consciousness depth monitoring system according to claim 3 or 4, characterized in that: The main controller is provided with an alarm unit, and the central processing unit is provided with a discrimination module. The EEG data threshold, cerebral blood oxygen threshold and NVCI threshold are set in the discrimination module. According to the set threshold, a judgment is made as to whether the calculated data in the EEG data processing module, the cerebral blood oxygen saturation data processing module and the joint data analysis module exceeds the set corresponding parameter threshold. If the set corresponding parameter threshold is exceeded, the alarm unit sends a warning signal to the outside.

6. The anesthesia and consciousness depth monitoring system according to claim 5, characterized in that: The main controller is also provided with a data storage module and a data output module. The data storage module is used to receive the processed data from the EEG data processing module, the cerebral blood oxygen saturation data processing module and the joint data analysis module in real time; the data output module is used to output the EEG data and the cerebral blood oxygen saturation data.

7. A method for anesthesia and depth of consciousness monitoring using the anesthesia and depth of consciousness monitoring system according to any one of claims 1 to 6, characterized in that: The method comprises the following steps: Step 1, attaching a flexible substrate with an anesthesia depth sensor and a cerebral blood oxygen saturation sensor to the forehead of a patient; Step 2, connecting the main controller to the anesthesia depth sensor and the cerebral blood oxygen saturation sensor respectively through cables; Step 3, the main controller sends a synchronization command acquisition signal to the anesthesia depth sensor and the cerebral blood oxygen saturation sensor, and the anesthesia depth sensor and the cerebral blood oxygen saturation sensor synchronously collect the EEG signal and the cerebral blood oxygen signal at the frontal brain area, collect the EEG signal and the cerebral blood oxygen signal of the frontal brain area, and transmit them to the main controller; Step 4: The main controller performs synchronous data processing to obtain current EEG data and cerebral blood oxygen saturation data, and displays real-time synchronous data and / or synchronous curves of the EEG data and cerebral blood oxygen saturation.

8. The method for anesthesia and depth of consciousness monitoring according to claim 7, characterized in that: The anesthesia depth sensor in step 1 performs synchronous detection of EEG signals and EOG signals on the left temple area, the right temple area, the left brow area, and the right brow area on both sides of the patient's forehead; the cerebral blood oxygen saturation sensor performs synchronous detection of cerebral blood oxygen signals on both sides of the patient's forehead.

9. The method for anesthesia and depth of consciousness monitoring according to claim 7, characterized in that: The method for achieving synchronous acquisition of EEG acquisition signals and cerebral blood oxygen saturation signals in step 3 is to control the cerebral blood oxygen acquisition frequency to be consistent with the EEG acquisition frequency in the main controller, and the main controller synchronously sends the command acquisition signal to the anesthesia depth sensor and the cerebral blood oxygen saturation sensor.

10. The method for anesthesia and depth of consciousness monitoring according to claim 7, characterized in that: The method for achieving synchronous acquisition of EEG acquisition signals and cerebral blood oxygen saturation signals in step 3 is that the main controller sends instruction acquisition signals to the anesthesia depth sensor and the cerebral blood oxygen saturation sensor respectively, and controls the EEG signal acquisition time point of the anesthesia depth sensor to be synchronized with the cerebral blood oxygen saturation sensor's cerebral blood oxygen signal acquisition time point.

11. The method for anesthesia and depth of consciousness monitoring according to claim 7, characterized in that: The method also includes a joint analysis step 5 of brain data in the forehead area, which performs a joint analysis on the EEG, EOG data and cerebral blood oxygen saturation data on the left and right sides of the forehead obtained in step 4 to obtain NVCI in the forehead area and display the value and / or trend curve.

12. The method for anesthesia and depth of consciousness monitoring according to claim 11, characterized in that: The method also includes an early warning step 6, in which thresholds are set in the main controller for the EEG data, cerebral blood oxygen saturation data and NVCI on the left and right sides of the forehead. When the EEG data, cerebral blood oxygen saturation data and NVCI at each position obtained in step 5 are greater than the set corresponding thresholds, the main controller sends a warning signal to the outside.

Images