CN120052831A - Wearable epilepsy diagnosis and treatment integrated device and application method thereof - Google Patents
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- A61B5/40—Detecting, measuring or recording for evaluating the nervous system
- A61B5/4076—Diagnosing or monitoring particular conditions of the nervous system
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- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
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Abstract
本发明公开了一种可穿戴式癫痫诊疗一体化装置及其使用方法，属于癫痫检测治疗技术领域，装置包括脑电采集模块、脑电检测模块和电控释药模块，脑电采集模块与脑电检测模块相连接，脑电检测模块与电控释药模块相连接。本发明采用上述的一种可穿戴式癫痫诊疗一体化装置及其使用方法，解决癫痫患者居家护理中遇到的癫痫随机发作问题，帮助癫痫患者减少精神类药物用药量进而降低毒副作用，减少患者的就医次数并提高其自主生活能力，改善癫痫患者的生活质量。
The present invention discloses a wearable integrated epilepsy diagnosis and treatment device and a method of using the same, which belongs to the technical field of epilepsy detection and treatment. The device includes an electroencephalogram acquisition module, an electroencephalogram detection module and an electric controlled drug release module. The electroencephalogram acquisition module is connected to the electroencephalogram detection module, and the electroencephalogram detection module is connected to the electric controlled drug release module. The present invention adopts the above-mentioned wearable integrated epilepsy diagnosis and treatment device and a method of using the same to solve the problem of random epileptic seizures encountered in home care of epilepsy patients, help epilepsy patients reduce the dosage of psychotropic drugs and thus reduce toxic and side effects, reduce the number of times patients seek medical treatment and improve their ability to live independently, and improve the quality of life of epilepsy patients.
Description
Technical Field
The invention relates to the technical field of epilepsy detection and treatment, in particular to a wearable epilepsy diagnosis and treatment integrated device and a use method thereof.
Background
Epilepsy is a chronic disease of the nervous system affecting people of all ages and is characterized by recurrent seizures caused by abnormal discharge of brain neurons. Seizures are sometimes accompanied by loss of consciousness and urinary incontinence by a transient involuntary seizure of a part of the body or of the whole body.
In the epilepsy treatment, patients can be treated by taking anti-epileptic drugs, but some patients still have poor treatment effect by using the anti-epileptic drugs, and the long-term taking of mental drugs can bring strong toxic and side effects. Seizures are unpredictable, frequent or occasional large seizures severely affect the quality of life of epileptics, and life safety of the patient may be compromised without external assistance in onset. If the prediction can be made before the epileptic seizure, and the intervention is performed by timely administration, the probability of the epileptic seizure can be greatly reduced, and the harm of the epileptic seizure to the body is reduced. The gold standard for judging the epileptic disease is an electroencephalogram at present, but the electroencephalogram needs to be observed by using hospital equipment, a common scalp electrode is a silver chloride wet electrode, conductive paste or conductive gel needs to be smeared on the scalp, so that people feel strong discomfort, real-time long-term observation cannot be supported, and the method is very inconvenient for epileptic patients.
In terms of drug delivery, conventional oral administration, transdermal administration have disadvantages of low efficiency, slow speed, limited drug selection, and the like.
Disclosure of Invention
The invention aims to provide a wearable epilepsy diagnosis and treatment integrated device and a use method thereof, which solve the problem of random seizure of epilepsy in home care of epileptics, help epileptics reduce the dosage of psychotic drugs, further reduce toxic and side effects, reduce the number of times of hospitalization of patients, improve the autonomous living ability of the patients and improve the living quality of epileptics.
In order to achieve the above purpose, the invention provides a wearable epileptic diagnosis and treatment integrated device, which comprises an electroencephalogram acquisition module, an electroencephalogram detection module and an electric control medicine release module, wherein the electroencephalogram acquisition module is connected with the electroencephalogram detection module, and the electroencephalogram detection module is connected with the electric control medicine release module;
The electroencephalogram acquisition module comprises an amplifier, a filter, an analog-to-digital converter, an electrode and a battery, wherein the amplifier is respectively and electrically connected with the electrode and the filter, the filter is electrically connected with the analog-to-digital converter, and the battery is electrically connected with the amplifier, the filter, the analog-to-digital converter and the electrode.
Preferably, the electroencephalogram detection module comprises a microcontroller, bluetooth and a mobile phone, wherein the microcontroller is respectively and electrically connected with the analog-to-digital converter and the Bluetooth, and the Bluetooth is electrically connected with the mobile phone.
Preferably, the electric control medicine release module comprises an electric control micro needle and a digital-to-analog converter, and the digital-to-analog converter is respectively and electrically connected with the microcontroller and the electric control micro needle.
The application method of the wearable epilepsy diagnosis and treatment integrated device comprises the following steps of:
Step one, collecting scalp electroencephalogram signals by using electrodes, and preprocessing the scalp electroencephalogram signals by using an amplifier, a filter, an analog-to-digital converter and a digital signal processor;
Step two, data are transmitted to a microcontroller, the microcontroller analyzes the preprocessed electroencephalogram data, and an epileptic detection result is transmitted to a mobile phone and visually displayed;
and thirdly, converting the drug release signal into voltage by the microcontroller through the digital-to-analog converter, and stimulating the electric control micro needle to release the drug.
Preferably, in the first step, the electrode is composed of a silver-silver chloride dry electrode, the electrode is attached to the scalp of a person through a head band, the amplification factor of the amplifier is 20-40dB, and the precision of the analog-digital converter is 16 bits.
In the second step, the electroencephalogram data is analyzed by adopting a time-frequency domain analysis method, and the specific operation is that firstly, a model of 1s is selected for wavelet transformation, a Harr wavelet basis is selected for converting a time domain signal into a time-frequency domain, a time-frequency diagram is analyzed in the time-frequency domain, the power of a high-frequency part of an electroencephalogram signal is obviously increased in a period before epileptic and during epileptic seizure, and the seizure condition of epileptic seizure is judged according to the information;
The method comprises the steps of packaging the seizure situation by 8 bytes, wherein the first four bytes are data identifications, the fifth six bytes are voltage data, the seventh eight bytes are check bits, sending results and preprocessed electroencephalogram signals to a computer through Bluetooth, and enabling the computer to receive and visualize the data by using a pyserial module and a pyqtgraph module in the python language, specifically using a Multiprocessing multiprocessing module, wherein the visualization comprises two parts, namely, real-time visualization of the electroencephalogram signals and alarm reminding visualization of seizure status.
Preferably, in the second step, the signal analysis is whether the seizure pre-signal is generated, if not, the starting phase is returned, and if the seizure pre-signal is generated, the step is entered into the third step.
Preferably, in the third step, judging whether the duration is 1min, if the duration is not required to be 1min, returning to the starting stage, and if the duration is required to be 1min, voltage excitation is carried out to release the medicine;
And judging whether the epilepsy is finished or not, returning to the starting stage if the epilepsy is finished, and continuing voltage excitation to release the medicine if the epilepsy is not finished.
The invention combines epileptic signal detection and drug delivery, takes an electric control microneedle as a carrier, and utilizes technologies such as microdevice processing, physiological signal detection, drug control and the like to develop the diagnosis and treatment integrated intelligent drug delivery system. The system acquires an electroencephalogram signal through the electrode, is connected with the signal processing and control module through the data transmission, and releases the medicine according to the need through the electric control microneedle in a voltage control mode after detecting the epileptic seizure by utilizing the intelligent recognition algorithm, and stops administration after detecting the epileptic seizure ending or the electroencephalogram signal is recovered to be normal, so that the dynamic monitoring and the integrated diagnosis and treatment of an epileptic patient are realized.
Therefore, the wearable epilepsy diagnosis and treatment integrated device and the use method thereof have the following beneficial effects:
(1) The problem of random seizure of epilepsy in home care of epileptics is solved, the epileptics are helped to reduce the dosage of psychotic drugs, further reduce toxic and side effects, reduce the number of times of hospitalization of the patients, improve the autonomous living ability of the patients and improve the living quality of the epileptics;
(2) The epileptic seizure status of the epileptic can be monitored in real time and the epileptic seizure status can be dosed as required, so that the epileptic seizure of the epileptic can be avoided or the symptom of the seizure can be relieved;
(3) The device is designed as a wearable headband, is small and flexible, and is convenient for the home use of patients;
(4) The brain electricity acquisition technology is mature, the electric control microneedle drug delivery technology is low in price and the whole cost is low;
(5) The electric control micro needle can be replaced after the medicine is used up, the service life of the equipment is long, and the use cost is further reduced.
The technical scheme of the invention is further described in detail through the drawings and the embodiments.
Drawings
Fig. 1 is a schematic structural diagram of a wearable epilepsy diagnosis and treatment integrated device and an embodiment of a using method thereof;
FIG. 2 is a flow chart of a wearable epilepsy diagnosis and treatment integrated device and a using method thereof according to an embodiment of the present invention;
FIG. 3 shows a drug release test of phenytoin sodium under different voltages according to an embodiment of the invention;
FIG. 4 shows a wearable epilepsy diagnosis and treatment integrated device and a polylactic acid microneedle with gold plated surface, according to an embodiment of the invention;
fig. 5 is a schematic illustration showing a polylactic acid microneedle after surface polymerization of pyrrole, according to an embodiment of the present invention.
Detailed Description
The technical scheme of the invention is further described below through the attached drawings and the embodiments.
Unless defined otherwise, technical or scientific terms used herein should be given the ordinary meaning as understood by one of ordinary skill in the art to which this invention belongs. The terms "first," "second," and the like, as used herein, do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. The word "comprising" or "comprises", and the like, means that elements or items preceding the word are included in the element or item listed after the word and equivalents thereof, but does not exclude other elements or items. The terms "connected" or "connected," and the like, are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "upper", "lower", "left", "right", etc. are used merely to indicate relative positional relationships, which may also be changed when the absolute position of the object to be described is changed.
Example 1
As shown in fig. 1, the invention provides a wearable epileptic diagnosis and treatment integrated device, which comprises an electroencephalogram acquisition module, an electroencephalogram detection module and an electric control medicine release module, wherein the electroencephalogram acquisition module is connected with the electroencephalogram detection module, and the electroencephalogram detection module is connected with the electric control medicine release module.
The electroencephalogram acquisition module is used for acquiring scalp electroencephalogram signals, then transmitting the scalp electroencephalogram signals to the electroencephalogram detection module, the electroencephalogram detection module is used for analyzing the scalp electroencephalogram signals, then transmitting the analysis result to the electric control medicine release module, and the electric control medicine release module is used for alkenyl electric control microneedles to release medicines, so that the illness state of a patient is controlled.
The electroencephalogram acquisition module comprises an amplifier, a filter, an analog-to-digital converter, an electrode and a battery, wherein the amplifier is respectively and electrically connected with the electrode and the filter, the filter is electrically connected with the analog-to-digital converter, and the battery is electrically connected with the amplifier, the filter, the analog-to-digital converter and the electrode.
The scalp electroencephalogram signal processing device comprises an electrode, a signal amplifier, a filter and an analog-to-digital converter, wherein the electrode is tightly attached to the scalp of a person and used for collecting scalp electroencephalogram signals, the specific arrangement mode of the electrode refers to an international 10-20 system, the signal amplifier is used for amplifying electroencephalogram signals as low as tens of microvolts, the amplification factor is 30dB, the filter is used for filtering out power frequency interference of 50Hz and background noise generated by movement and the like, and the analog-to-digital converter is used for converting the collected electroencephalogram signals into digital signals, and the conversion precision is 16 bits. The electroencephalogram acquisition module further comprises a digital signal processor, wherein the digital signal processor is used for packaging electroencephalogram signals and transmitting original data outwards, the battery is used for supplying power to the equipment, and button batteries can be used for enabling the duration to be about 7 days.
The brain electricity detection module comprises a microcontroller, bluetooth and a mobile phone, wherein the microcontroller is respectively and electrically connected with the analog-to-digital converter and the Bluetooth, and the Bluetooth is electrically connected with the mobile phone. The microcontroller is used for carrying out algorithm analysis on computer signals transmitted by the digital signal processor, wavelet transformation, power spectrum density analysis and the like, a Harr wavelet basis is adopted in the wavelet transformation, a detection threshold value is determined according to the power value of a normal signal in the power spectrum density analysis, a set drug release signal is output, bluetooth sends the detection result of the microcontroller to the mobile phone for early warning, and the mobile phone carries out visual display on the epileptic seizure condition so as to prompt a patient.
The electric control medicine releasing module comprises an electric control micro needle and a digital-to-analog converter, and the digital-to-analog converter is respectively and electrically connected with the microcontroller and the electric control micro needle. The digital-analog converter is used for converting the drug release signal output by the microcontroller into a voltage analog signal, and the electric control microneedle is used for releasing the drug.
As shown in fig. 4 and 5, the electric control microneedle is prepared from polylactic acid material by a reverse molding method, a high-precision 3D printing technology is used for printing a male mold, the material is photosensitive resin, polydimethylsilane is used for pouring polydimethylsilane into the male mold of the microneedle, baking is carried out at 60 ℃ for 20 minutes, polydimethylsilane is solidified to form the female mold of the microneedle, the polylactic acid microneedle is prepared by a high-temperature melting method, polylactic acid particles are placed on the surface of the female mold, polylactic acid is melted at a high temperature of 230 ℃, vacuum is extracted and cooled to form the polylactic acid microneedle, a gold conducting layer is sputtered on the surface of the microneedle by an ion sputtering instrument, so that the polylactic acid microneedle has conductivity, sputtering air pressure is 10mbar,15mA current is carried out, sputtering time is 12 minutes, and pyrrole doped with antiepileptic drugs sodium valproate, sodium phenytoin and carbamazepine is polymerized on the surface of the electric control microneedle by electrochemical reaction. The specific area of the electrically controlled micro-needle is 225mm 2, the surface is provided with a 15×15 micro-needle array, the length of each needle is 800 μm, the shape of a cone, and the diameter of the bottom surface is 300 μm.
The test of the release of phenytoin sodium is shown in fig. 3, and the graph shows that the phenytoin sodium can control the release rate by changing the voltage, and the release effect is obvious and stable. The main principle is that the drug release microneedle is used as an anode, pyrrole is subjected to oxidation reaction at the anode to generate a compact polypyrrole film, and the polypyrrole is doped with antiepileptic drugs. When releasing the medicine, the microneedle electrode is used as a cathode to perform a reduction reaction, the polypyrrole loses charge, and the medicine is released.
Polypyrrole is a common conductive polymer, polypyrrole can be generated by the oxidation reaction of pyrrole monomer attack, and can be embedded with negative medicines, and antiepileptic medicines such as sodium valproate, sodium phenytoin and the like are the first choice medicines. When the drug is released, the polypyrrole electrode undergoes a reduction reaction under the voltage stimulation, and the drug is released. When the sodium fluorescein is used as a model drug, the electrifying time and the drug release amount have obvious corresponding relation when the drug is released, and the characterization method of the sodium fluorescein is that an enzyme-labeled instrument measures absorbance at 496 nm. The characterization method of the medicines such as sodium valproate is High Performance Liquid Chromatography (HPLC), the chromatographic condition is that the mobile phase is methanol-water (80,20), the flow rate is 0.9mL/min, the detection wavelength is 265nm, the column temperature is 30 ℃, and the sample injection amount is 20 mu L. In this embodiment, the simulated epileptic brain electrical signal is used, the data is from boston children hospital (CHB-MIT SCALP EEG Database), the headband is worn against the head, the shielding of the hair is reduced as much as possible, when the epileptic signal is about to attack, the device will give an alarm, voltage excitation is started, the medicine loaded by the micro needle is released, when the epileptic pre-attack signal is finished, the voltage excitation is stopped, the micro needle immediately stops releasing the medicine, and the released sodium fluorescein is quantitatively measured by using an enzyme-labeled instrument.
The whole device is integrated into an integral headband and worn on the forehead, when the epileptic pre-seizure signal is detected, voltage excitation is started, the medicine is released, and after the epileptic pre-seizure signal disappears, the voltage excitation is stopped, so that closed-loop administration is realized.
As shown in fig. 2, the application method of the wearable epilepsy diagnosis and treatment integrated device includes the following steps:
Step one, collecting the scalp electroencephalogram signals by using electrodes, and preprocessing the scalp electroencephalogram signals by using an amplifier, a filter, an analog-to-digital converter and a digital signal processor. The electrode is composed of a silver-silver chloride dry electrode, the electrode is attached to the scalp of a person through a head band, the amplification factor of the amplifier is 20-40dB, and the precision of the analog-digital converter is 16 bits.
And step two, data are transmitted to the microcontroller, the microcontroller analyzes the preprocessed electroencephalogram data, and the epileptic detection result is transmitted to the mobile phone and is displayed visually.
The method for analyzing the electroencephalogram data by adopting time-frequency domain analysis comprises the specific operations of firstly selecting a model of 1s to carry out wavelet transformation, selecting a Harr wavelet basis, converting a time domain signal into a time-frequency domain, analyzing a time-frequency diagram of the time-frequency domain, wherein the power of a high-frequency part of an electroencephalogram signal is obviously increased before and during epileptic seizure, and judging the seizure condition of epileptic seizure according to the information;
the method comprises the steps of packaging the seizure situation by 8 bytes, wherein the first four bytes are data identifications, the fifth six bytes are voltage data, the seventh eight bytes are check bits, sending a result and a preprocessed starting electroencephalogram signal to a computer through Bluetooth, and enabling the computer to receive and visualize the data by using a pyserial module and a pyqtgraph module in the python language, specifically using a Multiprocessing multiprocessing module, wherein the visualization comprises two parts, namely, real-time visualization of the electroencephalogram signal and alarm reminding visualization of the seizure status.
And (3) whether the signal analysis is epileptic seizure pre-signal or not, if not, returning to a starting stage, and if so, entering a step (III).
And thirdly, converting the drug release signal into voltage by the microcontroller through the digital-to-analog converter, and stimulating the electric control micro needle to release the drug.
Judging whether the time lasts for 1min, returning to the starting stage if the time does not need to last for 1min, and if the time does need to last for 1min, activating the voltage to release the medicine.
And judging whether the epilepsy is finished or not, if so, returning to a starting stage, if not, continuing to release the medicine by voltage excitation, and continuing to administer medicine before the epileptic seizure pre-signal is finished, and stopping administration after the epileptic seizure pre-signal disappears, so as to realize closed-loop control of medicine release.
Therefore, the wearable epilepsy diagnosis and treatment integrated device and the use method thereof solve the problem of random seizures of epilepsy in home care of epileptics, help epileptics reduce the dosage of mental drugs, further reduce toxic and side effects, reduce the number of times of hospitalization of patients, improve the autonomous living ability of the patients, and improve the living quality of epileptics.
It should be noted that the above-mentioned embodiments are merely for illustrating the technical solution of the present invention and not for limiting the same, and although the present invention has been described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that the technical solution of the present invention may be modified or substituted by the same, and the modified or substituted technical solution may not deviate from the spirit and scope of the technical solution of the present invention.
Claims (8)
1. The wearable epileptic diagnosis and treatment integrated device is characterized by comprising an electroencephalogram acquisition module, an electroencephalogram detection module and an electric control medicine release module, wherein the electroencephalogram acquisition module is connected with the electroencephalogram detection module, and the electroencephalogram detection module is connected with the electric control medicine release module;
The electroencephalogram acquisition module comprises an amplifier, a filter, an analog-to-digital converter, an electrode and a battery, wherein the amplifier is respectively and electrically connected with the electrode and the filter, the filter is electrically connected with the analog-to-digital converter, and the battery is electrically connected with the amplifier, the filter, the analog-to-digital converter and the electrode.
2. The integrated device for diagnosis and treatment of wearable epilepsy according to claim 1, wherein the electroencephalogram detection module comprises a microcontroller, bluetooth and a mobile phone, the microcontroller is electrically connected with the analog-to-digital converter and the Bluetooth respectively, and the Bluetooth is electrically connected with the mobile phone.
3. The wearable epilepsy diagnosis and treatment integrated device of claim 1, wherein the electric control medicine release module comprises an electric control micro needle and a digital-to-analog converter, and the digital-to-analog converter is electrically connected with the micro controller and the electric control micro needle respectively.
4. The method for using the wearable epilepsy diagnosis and treatment integrated device according to any one of claims 1 to 3, comprising the following steps:
Step one, collecting scalp electroencephalogram signals by using electrodes, and preprocessing the scalp electroencephalogram signals by using an amplifier, a filter, an analog-to-digital converter and a digital signal processor;
Step two, data are transmitted to a microcontroller, the microcontroller analyzes the preprocessed electroencephalogram data, and an epileptic detection result is transmitted to a mobile phone and visually displayed;
and thirdly, converting the drug release signal into voltage by the microcontroller through the digital-to-analog converter, and stimulating the electric control micro needle to release the drug.
5. The method of claim 4, wherein in the first step, the electrode is composed of silver-silver chloride dry electrodes, the electrodes are attached to the scalp of a person through a head band, the amplification factor of the amplifier is 20-40dB, and the accuracy of the analog-digital converter is 16 bits.
6. The method for using the wearable epileptic diagnosis and treatment integrated device according to claim 4, wherein in the second step, the electroencephalogram data is analyzed by adopting a time-frequency domain analysis method, the specific operation is that firstly, a model of 1s is selected for wavelet transformation, a Harr wavelet basis is selected for converting a time domain signal into a time-frequency domain, a time-frequency diagram is analyzed in the time-frequency domain, the power of a high-frequency part of an electroencephalogram is obviously increased during a period before epileptic and during epileptic seizure, and the seizure condition of epileptic is judged by the information;
The method comprises the steps of packaging the seizure situation by 8 bytes, wherein the first four bytes are data identifications, the fifth six bytes are voltage data, the seventh eight bytes are check bits, sending results and preprocessed electroencephalogram signals to a computer through Bluetooth, and enabling the computer to receive and visualize the data by using a pyserial module and a pyqtgraph module in the python language, specifically using a Multiprocessing multiprocessing module, wherein the visualization comprises two parts, namely, real-time visualization of the electroencephalogram signals and alarm reminding visualization of seizure status.
7. The method of claim 4, wherein in the second step, the signal analysis is performed to determine whether the signal is a seizure pre-signal, if not, the start phase is returned, and if so, the third step is performed.
8. The method of claim 4, wherein in step three, judging whether to last for 1min, if not, returning to the starting stage, if so, continuing for 1min, and if so, releasing the drug by voltage excitation;
And judging whether the epilepsy is finished or not, returning to the starting stage if the epilepsy is finished, and continuing voltage excitation to release the medicine if the epilepsy is not finished.
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