CN117982184B - Craniocerebral state monitoring system for brain retractor operation and preparation method - Google Patents
Craniocerebral state monitoring system for brain retractor operation and preparation method Download PDFInfo
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Abstract
The invention discloses a cranium brain state monitoring system for brain retractor operation and a preparation method thereof, comprising a data acquisition module, a data transmission module, a data processing module, a data transmitting module and a flexible hydrogel substrate, wherein the data acquisition module is connected with the data processing module through the data transmission module, and the data processing module is connected with the data transmitting module; the data acquisition module, the data transmission module, the data processing module and the data sending module are arranged on the flexible hydrogel substrate; the data acquisition module comprises a physiological data acquisition module and an evoked potential acquisition module, and the evoked potential acquisition module and the physiological data acquisition module are connected with the data processing module through a data transmission module. The invention monitors the pressure of brain tissue traction and the condition of brain tissue oxygen in real time, reduces damage to brain tissue, improves the safety and effectiveness of operation, and protects the smooth development and accurate operation of craniotomy.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a craniocerebral state monitoring system for brain retractor operation and a preparation method thereof.
Background
Neurosurgery is a major treatment modality with surgery, involving diagnosis and treatment of systemic diseases of the central and peripheral nerves. Meanwhile, the nervous system is the most complex and sensitive system of the human body, and a doctor of the operation requirement operation of the nervous system is required to have rich medical foundation and practical operation background and also to execute accurate operation. However, during craniotomy procedures, the skull base or intra-brain surgery often requires pulling on the brain tissue to form a working channel to provide sufficient field of view and space for the procedure to complete, with a modulus of the brain tissue typically < 10kPa, and thus, extra brain tissue damage is extremely likely to occur from overdrawing.
At present, the common practice of craniotomy is to firstly pad a brain cotton sheet buffer layer at the position of a window on the brain surface, reduce the local damage to brain tissues caused by stress concentration of surgical instruments, and then use a brain retractor to draw and fix the brain tissues, thereby achieving the purpose of protecting the brain tissues. However, the strength and grasp of the traction are very experienced, and the operator is required to operate by long-term accumulated operation skills, so that the medical staff cannot timely perceive the physiological state of the patient during operation, and the risk of fatal disability is high. How to accurately and quantitatively feed back the influence of traction on brain tissues in the operation, record the real-time electrophysiological process of the brain tissues in real time during the traction, provide continuous physiological monitoring and early warning, and how to provide objective brain physiological function indexes such as pressure, evoked potential and the like for doctors in the process of traction on the brain tissues, so that the doctors can master the traction strength and skill as soon as possible, and reduce the extra brain tissue damage caused by the traction in the operation, thereby protecting the brain safety of patients, and being an important problem to be solved urgently.
For craniotomy of neurosurgery, doctors usually carry out intra-operation electrophysiological monitoring on the cranium in the neurosurgery process, the main method is to position the position of nerves and physiological signals and states of functional areas by means of brain electricity, electrical stimulation, evoked potentials and the like, assist the surgeons to search damaged parts and damage degrees, and timely avoid and discover damage to the functional areas and brain tissue nerve transmission paths caused by the operation. Depending on the needs of the surgery, electrophysiological monitoring methods include somatosensory evoked potentials, visual evoked potentials, auditory evoked potentials, electromyography, electroencephalogram, and the like. The operation method is that a commercial disposable nerve probe is usually placed near the nerve position to be measured and is measured intermittently. However, conventional commercial probes are hard materials, which can be significantly mechanically deformed by measurement on brain tissue, and differences in modulus at the device-tissue interface can also lead to baseline drift and signal artifacts, resulting in signals that are difficult to determine or even misjudge. The intra-operative electrophysiology monitoring system is often huge in size, cannot monitor the electrophysiology state completely in real time, and has a large limitation. Among the parameters currently monitored by electrophysiology, there are no quantitative indicators of damage and destruction to brain tissue when retracting, such as brain tissue oxygen, retracting pressure, etc.
Disclosure of Invention
The invention aims to provide a cranium brain state monitoring system for brain retractor operation and a preparation method thereof, which are used for monitoring the pressure for brain tissue traction and the condition of brain tissue oxygen in real time, reducing damage to brain tissue, improving the safety and effectiveness of operation, and protecting the smooth development and accurate operation of cranium operation.
The technical scheme adopted by the invention is as follows:
The cranium brain state monitoring system for brain retractor operation comprises a data acquisition module, a data transmission module, a data processing module, a data sending module and a flexible hydrogel substrate, wherein the data acquisition module is connected with the data processing module through the data transmission module, and the data processing module is connected with the data sending module; the data acquisition module, the data transmission module, the data processing module and the data sending module are arranged on the flexible hydrogel substrate;
The data acquisition module comprises a physiological data acquisition module and an evoked potential acquisition module, and the evoked potential acquisition module and the physiological data acquisition module are connected with the data processing module through a data transmission module;
The evoked potential acquisition module comprises an evoked potential electrode array for measuring nerve positions and potential attenuation conditions in operation and a stimulation electrode array for electrically stimulating a brain movement area so as to judge the potential conditions of the median nerve.
Preferably, the physiological data acquisition module includes a pressure sensor for acquiring pressure generated by the brain retractor on different areas of brain tissue during surgery and a brain tissue oxygen saturation acquisition front end for acquiring changes in brain local tissue oxygen.
Preferably, the brain tissue oxygen saturation acquisition front end comprises a photodetector and a light emitting diode.
Preferably, the pressure sensor is a piezoresistive flexible sensor;
The data transmission module is a flexible stretchable cable.
Preferably, the material of the flexible substrate is any one or more of polydimethylsiloxane PDMS, polyethylene terephthalate PET, polyimide PI and degradable plastic Ecoflex.
Preferably, the flexible hydrogel substrate comprises a top layer, a middle layer and a bottom layer which are sequentially arranged in a laminated way, wherein the layers are connected through oxygen plasma bonding; the evoked potential electrode and the stimulating electrode are arranged on the top layer of the flexible substrate and used for being contacted with a human body, the pressure sensing array is arranged on the middle layer, the brain tissue oxygen saturation acquisition front end is arranged on the bottom layer, and the flexible circuit layer is further arranged on the bottom layer.
The photoelectric detector, the light source and the flexible circuit board are arranged on the bottom layer, the materials of the top layer and the middle layer are polydimethylsiloxane PDMS, the materials of the bottom layer and the flexible circuit layer are polyimide PI, the flexible circuit layer is arranged on the bottom layer, and the flexible circuit layer is connected with the bottom layer and is provided with a data processing module and a data transmitting module.
Preferably, the data processing module comprises a core processing module, and an electroencephalogram acquisition front end, a brain tissue oxygen acquisition front end, a stimulator front end and an operational amplifier which are connected with the core processing module, wherein a power management chip is connected between the stimulator front end and the core processing module; the operational amplifier, the brain electricity collection front end, the brain tissue oxygen collection front end and the stimulator front end are respectively connected with the pressure sensor, the evoked potential electrode array, the brain tissue oxygen saturation collection front end and the stimulating electrode array.
Preferably, the data sending module is connected with a calculation processing module and an upper computer module;
The upper computer module also comprises an upper computer display module which is used for providing the current brain tissue state for the operator in real time and providing early warning information for the brain tissue.
Preferably, the calculation processing module can judge and predict the state of the intraoperative craniocerebral retractor through the signals acquired by the data acquisition module; the upper computer module is also connected with an alarm module, and the alarm function is started after abnormal values appear in the received data after the received data are processed by an algorithm; the calculation processing module is internally provided with a corresponding algorithm program, processes the acquired signals through the algorithm program, and internally processes the signals acquired by the data acquisition module, wherein the internal processing comprises the following specific processes: sequentially filtering, wavelet transformation and neural network model processing are carried out on signals, namely, after internal pressure, tissue oxygen and potential signals are collected, coupling time-threshold values are coupled, classification is carried out, and multi-mode information is fused through a convolutional neural network model to obtain a so-called alarm value;
The brain state monitoring system is placed at different intracranial positions to monitor nerve evoked potentials, the positions of brain partitions and nerves are judged, and the brain state monitoring system can give an electric stimulation signal to a motor partition to monitor the motor potentials.
A method of preparing a craniocerebral state monitoring system for use in brain retractor surgery as described above, comprising the steps of:
Step one: PDMS was mixed with a mass ratio of prepolymer to curing agent of 10:1, continuously stirring and uniformly mixing the materials, placing the materials into a vacuum box to extract vacuum, and then spin-coating the materials on a glass substrate; curing in an oven to fully cure the PDMS, covering a mask on the PDMS, and stripping the PDMS with the mask 301 from the glass;
step two: cutting the mask and the PDMS by using a laser cutting machine to cut through holes and blind holes;
Step three: uniformly coating the uncured flexible conductive composite material into the holes of the through holes and the blind holes by using a scraper; the vertical interconnection and multilayer conduction are realized by filling flexible conductive rechecking materials into the pores;
step four: placing the coated conductive composite material into an oven, and heating until the conductive composite material is cured;
step five: pouring and curing another layer of PDMS on the PDMS again to ensure that the blind holes are encapsulated in the system, so that crosstalk is prevented;
step six: attaching the chip to the blind holes and the through holes by using conductive silver paste, and curing to obtain a device with a front end acquisition chip and a sensor;
Step seven: the system was encapsulated by oxygen plasma bonding using PDMS.
The beneficial effects of the invention are as follows:
The flexible retractor system can monitor the evoked potential in the operation through the physiological data acquisition module and the evoked potential acquisition module, position the nerve position and the brain subarea, monitor the attenuation condition of the potential in the operation process, and further provide quantitative data support for an operating doctor; the pressure for pulling the brain tissue and the oxygen condition of the brain tissue can be monitored in real time, the safe operation is ensured, and the electric stimulation signal can be realized during the operation of a necessary movement functional area; meanwhile, the flexible retractor system can replace the traditional brain retractor, so that the aim of giving an operator enough visual field is achieved, meanwhile, compression damage to peripheral nerves is avoided, damage to brain tissues is reduced, safety and effectiveness of operation are improved, and smooth development and accurate operation of craniotomy are protected.
Drawings
FIG. 1 is a system frame schematic diagram of a craniocerebral state monitoring system for brain retractor surgery according to an embodiment of the present invention;
FIG. 2 is a schematic diagram of a craniocerebral state monitoring system for brain retractor surgery according to an embodiment of the present invention;
FIG. 3 is a flow chart of a method of preparing a craniocerebral state monitoring system for brain retractor surgery according to an embodiment of the present invention;
FIG. 4 is a top-level computer display of a craniocerebral state monitoring system for brain retractor surgery according to an embodiment of the present invention;
FIG. 5 is a graph of evoked potential application of a craniocerebral state monitoring system for brain retractor surgery according to an embodiment of the present invention;
FIG. 6 is a schematic illustration of the use of a craniocerebral state monitoring system for brain retractor surgery according to an embodiment of the present invention;
In the figure: 1-an upper computer module; 2-a calculation processing module; 3-convolutional neural networks; a 4-bandpass filter; a 5-radio frequency antenna; 6-serial ports; 7-USB; 8-clock crystal oscillator; 9-a core processing module; 10-a program downloading module; 11-a power management chip; a 12-operational amplifier; 13-a potential acquisition front end; 14-blood oxygen collection front end; 15-stimulation front; 16-flexible stretchable cable; 17-a pressure sensor; 18-an array of evoked potential electrodes; 19-a photodetector; 20-light emitting diodes; 21-an array of stimulation electrodes; a 22-algorithm module; 23-a data transmission module; 24-a data processing module; 25-a data transmission module; 26-a data acquisition module; 201-collecting a front-end top layer; 202-collecting a front end middle layer; 203 a flexible circuit layer; 204-stimulating electrodes; 205-an evoked potential electrode; 208-collecting a front end bottom layer; 301-masking; 302-PDMS; 303-glass; 304-a through hole; 305-blind holes; 306-underlying PDMS; 307-chip; 308-top layer PDMS; 501-central retrobulbar; 502-brain central anterior circuit; 503-median nerve; 601-glioma; 602-brain tissue; 603-retractor device.
Detailed Description
The present invention will be described in further detail with reference to the drawings and examples, in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.
In the description of the present invention, it should be understood that if there are terms such as "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", etc., the indicated azimuth or positional relationship is based on the azimuth or positional relationship shown in the drawings, it is merely for convenience of description and simplification of the description, and does not indicate or imply that the indicated apparatus or element must have a specific azimuth, be constructed and operated in a specific azimuth, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more of the described features. In the description of the present invention, the meaning of "a plurality" is two or more, unless explicitly defined otherwise.
In the description of the present invention, it should be noted that the terms "mounted," "connected," and "coupled" are to be construed broadly, as well as, for example, fixedly coupled, detachably coupled, or integrally coupled, unless otherwise specifically indicated and defined. Either mechanically or electrically. Can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
Example 1
The craniocerebral state monitoring system for brain retractor operation comprises a data acquisition module 26, a data transmission module 25, a data processing module 24, a data transmission module 23 and a flexible hydrogel substrate, wherein the data acquisition module 26 is connected with the data processing module 24 through the data transmission module 25, the data processing module 24 is connected with the data transmission module 23, and the data transmission module 23 is used for being connected with an upper computer module; the data acquisition module 26, the data transmission module 25, the data processing module 24 and the data transmission module 23 are all integrally packaged and arranged in the flexible substrate;
The data acquisition module 26 comprises a physiological data acquisition module and an evoked potential acquisition module, and the evoked potential acquisition module and the physiological data acquisition module are connected with the data processing module 24 through the data transmission module 25; the evoked potential acquisition module is used for acquiring auditory evoked potential and somatosensory evoked potential, and can output reverse current to generate a stimulation signal and a motion evoked potential;
The evoked potential acquisition module comprises an evoked potential electrode array 18 for measuring nerve position and potential attenuation in operation and a stimulating electrode array 21 for electrically stimulating the brain movement area to judge the potential of the median nerve; the electrode array is connected with the hydrogel top layer of the substrate in a bonding mode and is used for acquiring signals; the evoked potential electrode array 18 is attached to different parts of brain tissue for collecting the evoked potential of each nerve, such as placing the electrodes in the central anterior circuit of the brain, stimulating the median nerve, for somatosensory evoked potential monitoring.
Further, the stimulation electrode array 21 includes a plurality of stimulation electrodes 204 arranged in an array, and the evoked potential electrode array 18 includes a plurality of evoked potential electrodes 205 arranged in an array.
Further, the physiological data acquisition module comprises a pressure sensor 17 for acquiring pressure generated by the brain retractor on different areas of brain tissue during operation and a brain tissue oxygen saturation acquisition front end for acquiring changes of brain local tissue oxygen; is connected with the flexible substrate through conductive silver paste.
Further, the brain tissue oxygen saturation acquisition front end comprises a photodetector 19 and a light emitting diode 20.
Further, the pressure sensor 17 is a piezoresistive flexible sensor; carbon black materials are adopted as a structural framework and a conductive path, when pressure is generated in the pulling process, the material structure is compressed, the resistance is reduced, the conductivity is further enhanced, voltage signals are acquired by ADC (analog-to-digital converter) which is transmitted into STM32F103RC core module 9 after passing through an operational amplifier 12, and good signal sensitivity is achieved; the pressure sensor 17 is of an array type design, the sensor is of a piezoresistive type and capacitive type principle design, and the sensor is made of flexible materials.
Further, the data transmission module 25 is a flexible stretchable cable 16, printed on the substrate through a mask, and connected to the data acquisition chip and the data processing chip.
Further, the flexible retracting system comprises a sensor acquisition front end and a hardware processing rear end, and the front end and the rear end are electrically connected by adopting a flexible soft flat cable and a stretchable cable.
Example 2
Further limitations are imposed on the flexible substrate based on example 1, and the performance of example 2 after the limitation is more excellent.
The material of the flexible substrate is any one or a combination of a plurality of polydimethylsiloxane PDMS, polyethylene terephthalate PET, polyimide PI and degradable plastic Ecoflex.
Further, the flexible hydrogel substrate comprises a top layer, a middle layer and a bottom layer which are sequentially arranged in a laminated manner, and all the layers are connected through oxygen plasma bonding; the evoked potential electrode and the stimulating electrode are arranged on the top layer of the flexible substrate and used for being contacted with a human body, the pressure sensing array is arranged on the middle layer, the brain tissue oxygen saturation acquisition front end is arranged on the bottom layer, and the flexible circuit layer is further arranged on the bottom layer.
Further, the photodetector 19, the light source and the flexible circuit board are arranged on the bottom layer, the material of the top layer and the middle layer is polydimethylsiloxane PDMS, the material of the bottom layer and the flexible circuit layer is polyimide PI, the flexible circuit layer is arranged on the bottom layer, and the flexible circuit layer is connected with the bottom layer and is provided with a data processing module 24 and a data transmitting module 23.
The collection front end contains three layer construction, is collection front end top layer 201, collection front end intermediate level 202, collection front end bottom layer 208 respectively, and its collection front end top layer 201 is evoked potential electrode and electric stimulation electrode, and collection front end intermediate level 202 is power supply cable, and collection front end bottom layer 208 is data acquisition cable, and wherein collection front end bottom layer 208 top has arranged pressure sensor 17, photoelectric detector 19, carries out the electricity through electrically conductive solder paste and electrically conductive silver thick liquid and connects, and collection front end bottom layer 208 is arranged on collection rear end FPC board 203.
Further, the appearance of the flexible retractor system is in a strip shape, the whole flexible retractor system is packaged by adopting a flexible material, and the flexible retractor system is conformally attached to a medical brain retractor and used for retracting brain tissues in operation, so that a visual field of craniotomy is provided for doctors.
Further, the data processing module 24 includes a core processing module 9, and an electroencephalogram acquisition front end, a brain tissue oxygen acquisition front end, a stimulator front end and an operational amplifier 12 which are connected with the core processing module 9, wherein a power management chip 11 is connected between the stimulator front end and the core processing module 9, and data transmission is performed between each module and the core processing module 9 through communication protocols such as an I2C bus protocol, an SPI protocol, a GPIO and the like; the operational amplifier 12, the brain electricity collection front end, the brain tissue oxygen collection front end and the stimulator front end are respectively connected with the pressure sensor 17, the evoked potential electrode array 18, the brain tissue oxygen saturation collection front end and the stimulating electrode array 21 through flexible stretchable cables 16.
Further, the core processing module 9 is also connected with a clock crystal oscillator 8 and a program downloading module 10, the core processing module 9 adopts a controller chip with the model of STM32F103RC, the brain electricity acquisition front end adopts a ADS1299 chip, the brain tissue oxygen acquisition front end adopts a MAX30102 chip, and the stimulation front end 15 adopts a TENS-NS4 chip.
The acquisition front end is connected with a front end chip through a cable, the front end chip comprises an operational amplifier 12, an ADS1299 potential acquisition front end 13, a MAX30102 blood oxygen acquisition front end 14 and a TENS-NS4 stimulation front end 15, the operational amplifier 12 is electrically connected with a pressure sensor 17, the ADS1299 potential acquisition front end 13 is electrically connected with an evoked potential electrode array 18, the MAX30102 blood oxygen acquisition front end 14 is electrically connected with a photoelectric detector 19, and the TENS-NS4 stimulation front end 15 is electrically connected with a stimulation electrode array 21.
Further, the data processing module 24 is connected with the upper computer module 1 through the data transmitting module 23, the data transmitting module 23 is the radio frequency antenna 5, and the processed pressure, potential and brain tissue oxygen data are transmitted to the upper computer through transmission protocols such as bluetooth and WIFI.
Further, the data transmitting module 23 is connected with a calculation processing module and an upper computer module; together forming an algorithm module 22;
The upper computer module comprises an upper computer display module and is used for providing the current brain tissue state for an operator in real time and providing early warning information for the brain tissue;
further, a state monitoring algorithm and a multi-mode sensing fusion algorithm are arranged in the calculation processing module, the algorithm can be used for judging and predicting the state of the cranium in the operation, the upper computer is provided with an alarm module, and the alarm function can be started after abnormal values appear in received data after the received data are processed by the algorithm;
The monitoring system is placed at different intracranial positions to monitor nerve evoked potentials and judge the positions of brain partitions and nerves, and can give electric stimulation signals to the movement partitions to monitor the movement potentials.
Further, the back-end signal processing module comprises a front-end acquisition chip, a core processing module 9, a flexible power supply module and a transmitting module, the flexible power supply module comprises a battery and a power management chip 11 for supplying power to the flexible retraction system, the core processing chip schedules data and information, the clock crystal oscillator 8 provides clock information for the data, and the transmitting module can transmit the data to the upper computer module 1 through the radio frequency antenna 5, the serial port 6 and the USB.
Example 3
A method of preparing a craniocerebral state monitoring system for use in brain retractor surgery as described above, comprising the steps of:
Step one: PDMS was mixed with a mass ratio of prepolymer to curing agent of 10:1, continuously stirring and uniformly mixing the materials, placing the materials into a vacuum box to extract vacuum, and then spin-coating the materials on a glass substrate; curing in an oven to fully cure the PDMS, covering a mask on the PDMS, and stripping the PDMS with the mask 301 from the glass;
step two: cutting the mask and the PDMS by using a laser cutting machine to cut through holes and blind holes;
Step three: uniformly coating the uncured flexible conductive composite material into the holes of the through holes and the blind holes by using a scraper; the flexible conductive rechecking material is filled in the through holes and the blind holes, so that vertical interconnection and multilayer conductive connection are realized;
step four: placing the coated conductive composite material into an oven, and heating until the conductive composite material is cured;
step five: pouring and curing another layer of PDMS on the PDMS again to ensure that the blind holes are encapsulated in the system, so that crosstalk is prevented;
step six: attaching the chip to the blind holes and the through holes by using conductive silver paste, and curing to obtain a device with a front end acquisition chip and a sensor;
Step seven: the system was encapsulated by oxygen plasma bonding using PDMS.
Therefore, the brain retractor can be used as a traditional brain retractor for intraoperatively drawing brain tissues and exposing deep brain surfaces, an electronic system of the brain retractor can also be used for measuring evoked potential, oxygen, pressure and other parameters of the brain tissues in real time in the operation, and providing electric stimulation under a specific use scene so as to judge and predict the damage degree born by the brain tissues, thereby providing the assurance of the intraoperative parameters for operators.
The working principle of the invention is as follows: the invention provides a cranium brain state monitoring system for brain retractor operation, the system architecture block diagram is shown in figure 1, comprising a data acquisition module 26, a data transmission module 25, a data processing module 24, a data sending module 23 and an algorithm module 22; the data acquisition module 26 includes 4 pressure sensors 17 for acquiring pressures generated by the brain retractor on different areas of brain tissue during operation, an evoked potential electrode array 18 for measuring nerve positions and potential attenuation during operation, a photoelectric detector 19 and a light emitting diode 20 for acquiring oxygen changes of local brain tissue, and a stimulating electrode array 21 for electrically stimulating brain movement areas to judge the potential of the median nerve. Further, the data acquisition 26 module performs data transmission through the flexible stretchable cable 16, and sends the data to the data processing module 24; the pressure signal is connected with the operational amplifier 12, and the operational amplifier 12 plays a role in following and improving the signal carrying capacity; the evoked potential electrode array 18 is electrically connected with the ADS1299 potential acquisition front end 13; the stimulating electrode array 21 is electrically connected with the TENS-NS4 stimulating front end 15; according to the above scheme, the front end of the data processing module 24 is connected with the STM32F103RC core processing module 9 for task scheduling and management of the IO port; the clock chip 8 is used for providing clock information for the core processing module 9, and the program downloading module 10 is used for providing embedded programs for the core processing module 9; the power management chip 11 provides electric quantity for the stimulation front end 15 and the core processing module 9; the data signal is sent to the algorithm module 22 through the data sending module 23, and comprises a radio frequency antenna 5, a serial port 6 and a USB7, and can be transmitted through Bluetooth, WI-FI, UART and USB protocols; the algorithm module 22 comprises a band-pass filter 4 and a convolutional neural network 3, and enters the calculation processing module 2, and the calculation processing module 2 carries out down-sampling processing and judgment on data and sends the data to the upper computer module 1; the upper computer module 1 can display the current measured evoked potential waveform, brain tissue oxygen saturation, pressure data and current brain tissue state judgment, and provides a visual interface for doctors, thereby facilitating the traction and adjustment in operation.
According to the above scheme, the pressure sensor 17 adopts the piezoresistive flexible sensor, adopts the carbon black material as the structural framework and the conductive path, and when pressure is generated in the pulling process, the material structure is compressed, the resistance is reduced, the conductivity is further enhanced, the voltage signal is acquired by the ADC which is transmitted into the STM32F103RC core module 9 after passing through the operational amplifier 12, and the pressure sensor has good signal sensitivity.
According to the above scheme, the evoked potential electrode array 18 is attached to different parts of brain tissue for collecting the evoked potential of each nerve. If the electrode is placed in the central anterior circuit of the brain, the median nerve is stimulated, and the electrode is used for monitoring somatosensory evoked potential; in some embodiments, after the evoked potential acquisition is performed through the electrode array, the data is acquired through the ADS1299 potential acquisition front end 13, sampled through 16kHz, sent to the calculation processing module through the radio frequency antenna 5, and output to the upper computer module 1 through conversion, where the specific algorithm flow is as follows:
Step one: setting the stimulus frequency of the median nerve to 4.7Hz, the stimulus current to 30mA, the stimulus bandwidth to 0.1ms, setting the stimulus bandwidth to be automatic gain, starting a 50Hz trap, and starting the stimulator; the stimulator is a TENS-NS4 chip and is connected with the stimulating electrode array 21, and the stimulator sends out stimulating signals to be transmitted to the stimulating electrode array 21;
Step two: the stimulator is connected to the median nerve, the recording electrode is set as Cpi-Fz (the recording electrode is an evoked potential electrode array 18), the ground electrode is arranged between the recording electrode and the stimulating point (the ground electrode is used for grounding and reducing signal stimulation artifact) for electric stimulation, and the system acquires the data value of the evoked potential in real time after receiving the electric stimulation signal;
Step three: after each stimulus, intercepting data every 100ms, setting 30-300Hz band-pass comb filtering, setting down sampling to 1200Hz (the signal quantity can be reduced for processing), and obtaining evoked potential data after each 500 times of average superposition.
According to the above scheme, the stimulating electrode array 21 uses TENS-NS4 to stimulate the front end 15 to generate electric stimulation, the electric stimulation signals act on the central anterior circuit of the cerebral cortex, and the generated stimulating signals are transmitted to the peripheral nervous system through nerves, so as to generate potential changes and record the position of the central movement region.
In some embodiments, the flexible stretchable cable 16 material is a composite conductive material that is coated on a flexible substrate material to provide electrical connection through the through holes and blind holes.
According to the above scheme, the brain tissue oxygen sensor comprises a light emitting diode 20 and a photoelectric detector 19, wherein the light emitting diode 20 is a light source, the light source comprises a 660nm red light source and a 850nm infrared light source, the light source emits light alternately, wherein the oxyhemoglobin and the deoxyhemoglobin have different selectivities for the specific light source, the specific refractive index is displayed, the specific refractive index is received by the photoelectric detector 19, and then the specific refractive index is output to the MAX30102 blood oxygen collection front end 14 for data conditioning, the corresponding blood oxygen value is output, and the data is transmitted to the core processing module 9 through an I2C protocol, the core module transmits the data to the upper computer in a DMA mode, and when the blood oxygen saturation is reduced to be below 60 or above 90, the upper computer module 1 gives alarm information to prompt an operator to take corresponding measures.
In some embodiments, after the data processing receives the pressure, evoked potential and brain tissue oxygen data, the data is classified by the convolutional neural network 3 after passing through the 30-300Hz band-pass filter 4 and the 50Hz trap, and the brain state is judged and the intraoperative behavior is predicted. The computing processing system 2 is processed by MATLAB, and an upper computer is built by Python, is a visual interface and can display measured data waveforms and current states in real time.
The structure of the craniocerebral state monitoring system for brain retractor operation of the present invention is shown in fig. 2, and the retractor system is in a strip shape, and comprises a collection front top layer 201, a collection front middle layer 202, a collection rear FPC board serving as a flexible circuit layer 203, and a collection front bottom layer 208. The bottom layer 208 of the front end is connected with a photoelectric detector 19 and a light source, the middle layer 202 of the front end is provided with a pressure sensing array, the top layer is an evoked potential electrode 205 and a stimulating electrode 204, the whole retraction system is made of flexible materials, and the whole retraction system can be attached to a traditional brain retractor in a conformal manner and used together with the brain retractor to provide a visual field for the cranium brain. The materials of the collecting front top layer 201 and the collecting front middle layer 202 are polydimethylsiloxane, the layers are connected through an oxygen plasma bonding mode by adopting a flexible electronic manufacturing process and a micro-nano processing process, the material of the collecting front bottom layer 208 and the flexible circuit layer 203 are polyimide, and the two are connected through an FPC flexible circuit board. The stretchable cable is located above and below the layer to play a role in signal transmission, and the data sending module 23 and the data processing module 24 are located on the flexible circuit layer 203.
According to the above scheme, the core processing module 9 adopts an MCU chip, and interfaces such as ADC, SPI and I2C are integrated in the chip, so that the chip can be used for front end selection. The clock crystal 8 comprises a low-speed crystal and a high-speed crystal, and is used for recording time and providing processing time sequence for the core processing module 9. The MCU chip is connected with the WIFI module, the radio frequency antenna 5 is adopted for data transmission, the transmission mode of the MCU chip adopts a ciphertext format, the stability of signal transmission is guaranteed, meanwhile, the USB or UART mode can be adopted for wired data transmission, in the embodiment, firstly, an embedded software program is connected to the chip through a program downloading module 10 port, and internal control software is burnt into a main control chip.
In some specific embodiments, the stimulation front end 15 adopts a TENS-NS4 chip, the stimulation module is converted to 55V through a power supply built-in voltage boost converter to supply power, the stimulation current of the stimulation is divided into 12 gear positions, the stimulation current range is 3mA-57mA, the stimulation signal is positive and negative pulse signals, the specific stimulation mode adopts a traditional stimulation mode, namely, the stimulator is set to be a continuous pulse signal, after the stimulation signal is output to the stimulation electrode array 21 through the chip, the generated stimulation signal is transmitted to the upper limb median nerve through the central anterior-posterior movement region of the cerebral cortex, and the potential signal is measured.
According to the above scheme, the power management chip 11 can be connected to a lithium ion battery, and can be divided into DC-DC voltage boosting and reducing and LDO voltage stabilizing, so that the stability of power supply is ensured.
According to the above scheme, the operational amplifier 12 is an ADA4505 chip, and the voltage follower is used for providing a buffer function for the input voltage, providing high impedance input for the input voltage, improving the carrying capacity of signals, and reducing signal distortion caused by overload and electromagnetic interference.
A flowchart of a method of preparing a craniocerebral state monitoring system for use in brain retractor surgery is shown in fig. 3. The preparation method includes the preparation of the flexible stretchable cable 16, the preparation of the substrate and the system integration. The substrate is made of polydimethylsiloxane PDMS, and the preparation method comprises the following steps:
Step one: PDMS was mixed with a mass ratio of prepolymer to curing agent of 10:1, continuously stirring for 10 minutes, fully and uniformly mixing, placing into a vacuum box, vacuumizing for 5 minutes, and spin-coating on a glass substrate at a speed of 200rpm for 30 seconds. Then curing is carried out in an oven with the temperature of 90 ℃ and the heating time is 120min, and PDMS is fully cured. Next, the PDMS is covered with a mask 301 and peeled from the glass with mask 301 and PDMS 302.
Step two: cutting the mask and the PDMS by using a laser cutting machine, and cutting a through hole 304 and a blind hole 305 according to different cutting parameters, wherein the cutting parameters of the through hole are that the laser intensity is set to be 40 and the speed is 5; the parameters of the blind hole cutting are that the laser intensity is set to be 10 and the speed is set to be 15.
Step three: uniformly coating uncured flexible conductive composite material into the pores by using a scraper, wherein the preparation process of the conductive composite material comprises the following steps:
s1: putting silver powder and ethanol into a beaker, magnetically stirring for 15min, taking out stirring magnetic beads, putting the solution into a centrifuge tube for centrifugation, pouring out supernatant, and repeating for five times;
s2: removing the dispersed silver powder, putting the silver powder into a vacuum drying oven for drying for 12 hours, and finishing cleaning;
s2: taking the silver powder after cleaning: PDMS (polydimethylsiloxane) in mass ratio of 3:1, adding a mortar, and grinding to fully and uniformly mix silver powder and PDMS;
Step four: placing the coated conductive composite material into an oven, setting the temperature to 160 ℃, and heating for 2 hours until the conductive composite material is solidified, wherein the composite material has conductivity and stretchability;
Step five: pouring and curing another layer of PDMS on the PDMS again to ensure that the blind holes 304 are packaged in the system, so that crosstalk is prevented;
Step six: attaching the chip to the blind holes and the through holes by using conductive silver paste, and curing at 70 ℃ to obtain a device with a front end acquisition chip and a sensor;
step seven: and packaging the system by using PDMS (polydimethylsiloxane) by using an oxygen plasma bonding technology, wherein the power of oxygen plasma is set to be 125W, and the bonding time is set to be 5min.
Fig. 4 is a diagram showing a superior computer display of a craniocerebral state monitoring system for brain retractor surgery. The system can adjust the sampling rate of the signal, the filtering range of the filter and whether the trap is opened, and when the serial port 6 is adopted to receive the signal, the baud rate and check bit of the serial port 6 can be set and the obtained signal curve can be stored. The upper computer module 1 can record the original data of the nerve evoked potential, including various signals such as visual evoked potential, auditory evoked potential, somatosensory evoked potential and the like, and judge the current real-time state; in some embodiments, such as exercise evoked potential and somatosensory evoked potential, when the real-time recorded evoked potential amplitude is less than 50% of the initial amplitude or the latency is prolonged by more than 10%, the system gives an alarm prompt, the current state is changed to a red early warning state, and the operating doctor is reminded to process related problems; the upper computer module 1 can also record the real-time pressure value of the brain tissue or glioma and the like, and when the pressure value exceeds the pressure in the critical range, for example, the pressure is overlarge or the time for applying the pressure is overlong, the pressure existence time and alarm information can be given, so that the operator is prompted to control the retraction pressure; meanwhile, the system automatically monitors the oxygen saturation range of the local brain tissue oxygen, and when the local brain tissue oxygen is lower than 60, the patient is in a state that the brain blood vessel is pressed, and the retractor is prompted to be timely loosened so as to restore the normal blood oxygen value; in some embodiments, advanced modules may be added, such as brain power spectral density analysis, which may locate a lesion of an epileptic location in real time; the data of the current brain tissue state is stored for subsequent recording and playback of the procedure.
An evoked potential application diagram for a craniocerebral state monitoring system for brain retractor surgery is shown in fig. 5. Generally, the technology of nerve electrophysiology in operation is mainly used for monitoring the functional integrity of nervous system in dangerous state, and common monitoring means for craniocerebral tumor, C1-C2 operation, thoracolumbar operation, etc. are somatosensory evoked potential and exercise evoked potential. The central postnatal loop 501 is the primary sensory cortex of the central postnatal loop, the central postnatal loop 502 corresponds to the motor cortex of the central postnatal loop, and the evoked potential electrode array 18 corresponds to the recorded area for the present system, and a bidirectional negative-positive evoked potential (N20, P30) is generated.
A method of using the craniocerebral state monitoring system for brain retractor surgery is shown in fig. 6. In some specific real-time cases, such as treatment and monitoring of diseases such as aneurysms, cerebral arteriovenous malformations, etc., the system plays a vital role. As shown in fig. 6, the flexible retractor system can be used together with a traditional brain retractor, tools such as a bipolar and an aspirator for operation are placed in the brain, tumors can be resected by using the bipolar, the position of the retractor system is continuously adjusted, a doctor can check the pressure and physiological parameters of brain tissue retraction in the system, and further the current state of the brain tissue is reflected, and in the operation process, the intracranial space is limited, so that the vision of the doctor in operation is often blocked, and the system is required to be used for retracting the position of a nonfunctional area of the brain tissue for multiple times, so that convenience is provided for the subsequent operation process while sufficient vision space is obtained.
The invention adopts the manufacturing process of rigid-flexible combination and printing, and all materials are flexible materials except the chip which is made of rigid materials, and the PDMS is adopted for packaging, so that the whole body has biocompatibility, and in the use process, the device can be in flexible contact with brain tissues, thereby playing a role of buffering, being capable of being attached in a conformal manner, reducing motion artifacts and obtaining data with higher fidelity. The system integrates a flexible pressure sensor 17, a brain tissue oxygen sensor and a gold electrode array, and has high sensitivity, wide linear range and rapid signal response capability. Because the system can be attached to the vicinity of the nerve in a dangerous state, the focus state can be fed back in time, the position of the brain partition can be judged, the functional area can be avoided as much as possible, and the safe operation of the operation is ensured. The current neurosurgery operation completely depends on the hand feeling of operators, risks brought to brain tissues can not be quantitatively reflected by virtue of experience operation, so that indexes of pressure, potential and brain tissue oxygen brought in the process of pulling the brain tissues are provided for doctors as much as possible under the condition of not affecting the visual field in operation, the positions of brain partitions and nerves can be effectively judged through the change of the potential, real-time analysis by the doctors is facilitated, when abnormality occurs in data, an upper computer can timely send out alarm and abnormal data information, and the operators can take treatment measures. The invention can continuously monitor the brain state in real time, give a prompt when necessary, monitor the brain tissue state of a patient and effectively reduce the death disability rate. The invention can find the change condition of intracranial injury in early stage, guide clinical treatment and judge prognosis of patients, and provides a new treatment tool and system for neuroprotection and intraoperative monitoring.
In summary, the invention relates to a brain state monitoring system and a preparation method for brain retractor operation, comprising an evoked potential acquisition module, a physiological data acquisition module, a data transmission module 25, a data processing module 24, a calculation processing module and an upper computer display module, wherein the physiological signal acquisition module is a flexible substrate, flexible physiological electrodes, a photoelectric detector 19, a stimulating electrode and a pressure sensor 17 are distributed on the substrate, the physiological electrodes are used for acquiring signals such as somatosensory evoked potential, auditory evoked potential and visual evoked potential in neurosurgery, the photoelectric detector 19 and the pressure sensor 17 are used for acquiring pressure generated by brain upper brain retractor process on brain tissues and change process of tissue oxygen, the stimulating electrode is used for positioning and monitoring of the exercise area, and the signals are transmitted to the data processing module 24 through flexible stretchable wires after being acquired, and are sent to real-time parameters and brain tissue evoked potential states in the upper computer module after being processed by algorithms. Meanwhile, the surface of the acquisition device is packaged with a flexible biocompatible hydrogel material, so that the acquisition device can replace a traditional brain retractor, and has the functions of drawing brain tissues, providing visual field for operators, providing monitoring of evoked potential and stimulating potential in the whole process, reducing damage to the brain tissues, improving safety and effectiveness of operation, and protecting smooth development and accurate operation of craniotomy.
It is noted that relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.
It will be understood that modifications and variations will be apparent to those skilled in the art from the foregoing description, and it is intended that all such modifications and variations be included within the scope of the following claims.
Claims (7)
1. A craniocerebral state monitoring system for brain retractor surgery, comprising: the device comprises a data acquisition module, a data transmission module, a data processing module, a data sending module and a flexible hydrogel substrate, wherein the data acquisition module is connected with the data processing module through the data transmission module, and the data processing module is connected with the data sending module; the data acquisition module, the data transmission module, the data processing module and the data sending module are arranged on the flexible hydrogel substrate;
The data acquisition module comprises a physiological data acquisition module and an evoked potential acquisition module, and the evoked potential acquisition module and the physiological data acquisition module are connected with the data processing module through a data transmission module;
the evoked potential acquisition module comprises an evoked potential electrode array for measuring the nerve position and the potential attenuation condition in the operation and a stimulation electrode array for electrically stimulating the brain movement area so as to judge the potential condition of the median nerve;
The physiological data acquisition module comprises a pressure sensor for acquiring the pressure generated by the brain retractor on different areas of brain tissue in operation and a brain tissue oxygen saturation acquisition front end for acquiring the change of brain local tissue oxygen;
the flexible hydrogel substrate comprises a top layer, a middle layer and a bottom layer which are sequentially arranged in a laminated way, and all the layers are connected through oxygen plasma bonding; the evoked potential electrode and the stimulating electrode are arranged on the top layer of the flexible substrate, the pressure sensing array is arranged on the middle layer, the front end for collecting oxygen saturation of brain tissue is arranged on the bottom layer, and the flexible circuit layer is arranged on the bottom layer;
The brain state monitoring system is placed at different intracranial positions to monitor nerve evoked potentials, is conformally attached to a traditional brain retractor and is matched with the brain retractor to achieve the purposes of giving an operator enough visual field, simultaneously avoiding compression damage to peripheral nerves, reducing damage to brain tissues, judging brain areas and positions of the nerves, and can give an electric stimulation signal to a motion area to monitor the motion potential;
The physiological data acquisition module and the evoked potential acquisition module are used for carrying out evoked potential monitoring in operation, positioning the nerve position and brain partition, and monitoring the attenuation condition of the potential in the operation process, so as to provide quantitative data support for an operating doctor; and the pressure of pulling the brain tissue and the oxygen condition of the brain tissue are monitored in real time, so that the safe operation is ensured, and an electric stimulation signal is realized during the operation of the sports function area.
2. The craniocerebral state monitoring system for brain retractor surgery of claim 1, wherein: the front end for collecting the oxygen saturation of the brain tissue comprises a photoelectric detector and a light emitting diode.
3. The craniocerebral state monitoring system for brain retractor surgery of claim 1, wherein: the pressure sensor adopts a piezoresistive flexible sensor; the data transmission module is a flexible stretchable cable.
4. The craniocerebral state monitoring system for brain retractor surgery of claim 1, wherein: the material of the flexible substrate is any one or a combination of a plurality of polydimethylsiloxane PDMS, polyethylene terephthalate PET, polyimide PI and degradable plastic Ecoflex.
5. The craniocerebral state monitoring system for brain retractor surgery of claim 1, wherein: the data processing module comprises a core processing module, and an electroencephalogram acquisition front end, a brain tissue oxygen acquisition front end, a stimulator front end and an operational amplifier which are connected with the core processing module, wherein a power management chip is connected between the stimulator front end and the core processing module; the operational amplifier, the brain electricity collection front end, the brain tissue oxygen collection front end and the stimulator front end are respectively connected with the pressure sensor, the evoked potential electrode array, the brain tissue oxygen saturation collection front end and the stimulating electrode array.
6. The craniocerebral state monitoring system for brain retractor surgery of claim 1, wherein: the data transmitting module is sequentially connected with a calculation processing module and an upper computer module.
7. The craniocerebral state monitoring system for brain retractor surgery of claim 6, wherein: the calculation processing module can judge and predict the state of the craniocerebral retractor in operation through the signals acquired by the data acquisition module; the upper computer module is also connected with an alarm module, and the alarm function can be started after abnormal values appear in the received data after the received data are processed by an algorithm.
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