Visual closed-loop diagnosis and treatment system based on electrical stimulation

Abstract

The invention relates to a visual closed-loop diagnosis and treatment system based on electrical stimulation, and the system comprises an image collection module which is used for collecting external video image information; the image processing module is used for processing and coding the received video image information into a nerve electrical stimulation coding signal and sending the nerve electrical stimulation coding signal to the electrical stimulation control module; the electrical stimulation control module is softly attached to the visual cortex of the brain of the patient or the animal, and is used for further processing the received electrical nerve stimulation coding signal, outputting a corresponding electrical stimulation parameter and controlling a corresponding flexible electrode to output an electrical signal to stimulate nerve cells; and the stimulation effect evaluation module is used for collecting the biomarker concentration of the patient and evaluating the safety and effectiveness of electrical stimulation after data analysis. According to the visual diagnosis and treatment closed-loop system based on electrical stimulation, the effect of residual vision protection is achieved by setting safe and accurate electrical stimulation parameters, a feedback closed loop is formed through the stimulation effect evaluation module, and the safety and effectiveness of stimulation are effectively improved.

Description

Technical Field

[0001] This application relates to the field of neuroelectric stimulation technology, and in particular to a visual closed-loop diagnostic and treatment system based on neuroelectric stimulation. Background Technology

[0002] Visual impairment is one of the major public health challenges facing the world. According to statistics, approximately 39 million people worldwide are completely blind, and at least 2.2 billion people have some form of visual impairment, representing about 28% of the world's total population. In China, there are approximately 5.5 million people who are completely blind, accounting for 0.4% of the total population, while the total number of people with visual impairment is approximately 17-17.5 million, representing 1.2% of the total population. Behind these figures lies the suffering of countless families and the increased burden on society.

[0003] Among the many causes of visual impairment, cataracts, glaucoma, age-related macular degeneration (AMD), retinitis pigmentosa (RP), and diabetic retinopathy are considered the leading causes of blindness. Although these diseases have different causes, they all involve damage and death of retinal neurons, ultimately leading to severe impairment of visual function. Traditional treatments mainly focus on treating the underlying cause and alleviating symptoms, such as surgical treatment for cataracts, intraocular pressure-lowering treatment for glaucoma, and anti-VEGF therapy for AMD. However, when the disease progresses to advanced stages, especially when there is extensive death of retinal ganglion cells or severe visual impairment, traditional ophthalmological treatments often fail to achieve satisfactory results.

[0004] In recent years, neurostimulation technology, as an emerging neuromodulation method, has shown great potential in the treatment of ophthalmic diseases. Existing electrical stimulation techniques mainly apply electrical signals with specific parameters to the retina, visual cortex, or periocular tissues through invasive or non-invasive methods. This can activate residual neurons in the visual pathway, promoting neuroprotection and functional recovery. Among these, neural prostheses implanted in the retina and visual cortex have been proven to reconstruct basic vision through electrical stimulation of the visual pathway, helping blind people recognize large, simple shapes in hallucinations and facilitating daily life. Neurostimulation is a core technology connecting devices to brain tissue and achieving neural signal modulation; its parameter design, mode selection, and safety control directly determine the system's effectiveness and biocompatibility.

[0005] However, in existing neurostimulation technologies, the stimulation parameters are basically fixed. Due to significant individual differences and variations in disease progression, the homogeneous stimulation effect and safety based on population statistical patterns are unsatisfactory. Furthermore, the use of electrical stimulation of the visual pathway for neuroprotection and improvement of residual vision faces challenges beyond individualized parameter settings. There is a lack of evaluation methods to promptly track biochemical events such as neural remodeling and inflammatory factors induced by electrical stimulation. Visual protection is a long-term process, making it difficult for patients to adhere to the treatment, and doctors are unable to selectively adjust the stimulation parameters.

[0006] Therefore, existing technologies still need to be improved and developed. Summary of the Invention

[0007] Based on this, this application provides a closed-loop visual diagnosis and treatment system based on electrical stimulation. It combines a stimulation effect evaluation module related to neural markers to evaluate the effect of electrical stimulation, and sets different electrical stimulation parameters through an electrical stimulation control module to achieve safer and more accurate photopsychopathic effects and visual protection effects, effectively improving the safety and effectiveness of visual electrical stimulation.

[0008] To achieve the above objectives, embodiments of this application provide a visual closed-loop diagnostic and treatment system based on electrical stimulation, comprising:

[0009] Image acquisition module, which is used to acquire external video image information;

[0010] The image processing module is used to process and encode the received video image information into a specific neural electrical stimulation encoded signal and send it to the electrical stimulation control module;

[0011] An electrical stimulation control module is compliantly attached to the visual cortex of a patient or animal's brain. It is used to further process the received neural electrical stimulation encoded signals, output corresponding electrical stimulation parameters, and control the corresponding flexible electrodes to output electrical signals to stimulate nerve cells.

[0012] The stimulation effect evaluation module is used to collect the patient's biomarker concentrations and evaluate the safety and effectiveness of electrical stimulation after data analysis.

[0013] Preferably, the electrical stimulation control module includes a waveform generator integrating a neurostimulator integrated circuit and peripheral components, a communication submodule for receiving energy and neurostimulation encoded signals, and an encapsulation submodule that covers the waveform generator and meets implantable biocompatibility requirements.

[0014] The packaged submodule includes a packaged substrate with multiple metal wires on it. One end of each metal wire is connected to multiple pins of a waveform generator, and the other end is connected to a flexible electrode with multiple channels, so that each independent output pin of the waveform generator is connected to each channel of the flexible electrode. The stimulation electrode point at the other end of the flexible electrode is closely attached to the surface of the visual cortex of the brain.

[0015] Preferably, the waveform generator uses a specific waveform stimulation from a constant current source, and the flexible electrode points of each channel can be independently controlled by the electrical stimulation control module. The electrical stimulation parameters include amplitude, duty cycle, waveform, interval, waveform frequency, and waveform interval.

[0016] Preferably, the communication submodule obtains power supply and nerve stimulation encoding signals via wired means or via radio waves, and then the waveform generator performs radio wave rectification and energy distribution, and wireless data decoding.

[0017] Preferably, the electrical stimulation control module is configured with a minimum current and a maximum current for electrical stimulation, wherein the minimum current is not less than 1uA and the maximum current is not more than 5mA.

[0018] The actual value of the minimum current is determined based on the waveform of nerve emission collected by the adjacent electrode to determine the minimum threshold current of the nerve response; or by animal behavior, human patients' photophantom perception, and visual quality assessment reports to determine the minimum threshold current of the effective stimulus.

[0019] The safe value of the maximum current is determined by significant changes in biomarkers of brain nerve damage and brain inflammation caused by electrical stimulation over a period of time.

[0020] Preferably, the markers of brain nerve damage include neuron-specific enolase NSE, calcium-binding protein S100B, and neurofilament light chain NfL;

[0021] The biomarkers of brain inflammation include IL-1β, IL-6, IL-8, IL-17, IFN-γ, and TNF-α.

[0022] Preferably, after patients or animals are subjected to electrical stimulation, the markers of visual-related neuroprotection and neural remodeling include brain-derived neurotrophic factor (BDNF), glial cell-derived neurotrophic factor (GDNF), growth-associated protein (GAP-43), nerve growth factor (NGF), fibroblast growth factor (FGF-2), synaptic protein (Synapsin I), and glial fibrillary acidic protein (GFAP).

[0023] Preferably, the stimulation effect evaluation module includes:

[0024] The collection unit is used to collect biological samples from patients or animals at several time points in three stages: before implantation of the electrical stimulation control module, after implantation of the electrical stimulation control module, before electrical stimulation, and after electrical stimulation. The biological samples include cerebrospinal fluid, blood, saliva, tears, and urine.

[0025] The detection unit, after the biological sample has undergone conventional sample pretreatment, uses electrochemiluminescence, single-molecule detection, flow cytometry, or adjacent extension techniques to quantitatively detect the concentration of one or more biomarkers, thereby assessing neuro-related biochemical activities after brain implantation.

[0026] Preferably, the stimulation effect evaluation module further includes:

[0027] Ophthalmic equipment and scales used to examine a patient's visual acuity and visual evoked potentials.

[0028] Preferably, based on the quantitative values ​​from the stimulation effect evaluation module, the stimulation parameters of the waveform generator are changed through the external electrical stimulation control module and communication submodule, making the electrical stimulation safer and more effective, thereby achieving the purpose of closed-loop feedback adjustment.

[0029] The visual closed-loop diagnostic and treatment system based on electrical stimulation provided by this invention has the following advantages and beneficial effects:

[0030] Based on the quantitative values ​​from the stimulation effect evaluation module, the stimulation parameters of the waveform generator are changed through the external electrical stimulation control module, making the electrical stimulation safer and more effective, thereby achieving the purpose of closed-loop feedback adjustment. Attached Figure Description

[0031] Figure 1 This is a schematic diagram of the modules of the visual closed-loop diagnosis and treatment system based on electrical stimulation according to this application.

[0032] Figure 2 This is a schematic diagram of the image acquisition module and image processing module in the visual closed-loop diagnosis and treatment system based on electrical stimulation of this application.

[0033] Figure 3 This is a schematic diagram of the electrical stimulation control module in the visual closed-loop diagnosis and treatment system based on electrical stimulation according to this application.

[0034] Figure 4 This is a partial structural diagram of the electrical stimulation control module in the visual closed-loop diagnosis and treatment system based on electrical stimulation of this application.

[0035] Figure 5 This is a schematic diagram of the electrical stimulation control module implanted in the monkey visual cortex in the visual closed-loop diagnosis and treatment system based on electrical stimulation according to this application.

[0036] Figure 6This is a schematic diagram of the flexible electrode attached to the V1 surface of the monkey's visual cortex in the visual closed-loop diagnosis and treatment system based on electrical stimulation according to this application. Detailed Implementation

[0037] To facilitate understanding of this application, a more complete description will be provided below with reference to the accompanying drawings, which illustrate preferred embodiments of the application. However, this application may be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that the disclosure of this application will be thorough and complete.

[0038] It should be noted that when a component is considered to be "connected" to another component, it can be directly connected to and integrated with the other component, or there may be an intervening component present. The term "mounted" and similar expressions used in this document are for illustrative purposes only.

[0039] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the specification of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0040] like Figure 1 and Figure 2 As shown, a visual closed-loop diagnostic and treatment system based on electrical stimulation is provided, which includes:

[0041] Image acquisition module, which is used to acquire external video image information;

[0042] The image processing module is used to process and encode the received video image information into a specific neural electrical stimulation encoded signal and send it to the electrical stimulation control module;

[0043] An electrical stimulation control module is compliantly attached to the visual cortex of a patient or animal's brain. It is used to further process the received neural electrical stimulation encoded signals, output corresponding electrical stimulation parameters, and control the corresponding flexible electrodes to output electrical signals to stimulate nerve cells.

[0044] The stimulation effect evaluation module is used to collect the patient's biomarker concentrations and evaluate the safety and effectiveness of electrical stimulation after data analysis.

[0045] Nerve cells, including neurons and glial cells, can be stimulated by setting different parameters to produce photic hallucinations, protect the visual pathway, and improve residual vision.

[0046] In specific implementation, such as Figure 3 and Figure 4 As shown, the electrical stimulation control module includes a waveform generator 100 integrating a neurostimulator integrated circuit and peripheral components, a communication submodule 200 for receiving energy and neurostimulation coded signals, and an encapsulation submodule 300 that covers the waveform generator and meets implantable biocompatibility requirements. The encapsulation submodule 300 includes an encapsulation substrate 301, on which multiple metal wires are disposed. One end of each metal wire is connected to multiple pins of the waveform generator 100, and the other end is connected to a multi-channel flexible electrode 400, such that each independent output pin of the waveform generator 100 is connected to each channel of the flexible electrode. The stimulation electrode point at the other end of the flexible electrode 400 is closely attached to the surface of the visual cortex of the brain.

[0047] The electrical stimulation control module can independently and controllably stimulate nerve cells (including neurons and glial cells) with corresponding flexible electrodes. Different stimulation parameters can not only produce photic hallucinations, but also protect the visual pathway and improve residual vision.

[0048] The number of channels on the flexible electrode ranges from several to thousands, with 128 channels being preferred. The diameter of the flexible electrode can range from 20 micrometers to 2 mm, and the center-to-center spacing is typically on the order of micrometers to millimeters, with a spacing of at least three times the electrode diameter. The flexible electrode is attached to the V1 area of ​​the primary visual cortex, but areas V2-V4 or multiple visual cortex areas can also be selected. The electrode area of ​​the flexible electrode should conform as closely as possible to the folds of the visual cortex.

[0049] Flexible electrodes are placed in specific areas of the visual cortex. By using different electrical stimulation parameters, the spatial topological correspondence between the location of electrical stimulation in the cortex and the patient's perception can be found through human experiments and training. Through stimulation strategies such as dynamic currents with a specific temporal and spatial sequence, preliminary image and text vision can be formed within the visual field of visually impaired individuals. Changing the electrical stimulation frequency (10-1 kHz, combined with a specific stimulation current waveform) may potentially achieve colored photophobic pixels. If the current is below the electrical stimulation threshold, photophobic visions will not occur, but there is a potential neuroprotective effect and improvement of residual vision.

[0050] This application uses flexible electrodes to generate photopsychic visions, forming meaningful symbols and cues. By changing stimulation parameters, it can also protect residual vision, improve visual quality, prevent further deterioration of eye diseases leading to blindness, and has the potential to reconstruct the brain's visual pathways.

[0051] The image processing module is equipped with an AI algorithm that can process and encode video image information into specific neural electrical stimulation encoded signals.

[0052] This communication submodule obtains power supply and neural electrical stimulation encoded signals via wired means or via radio waves through coils, etc. The waveform generator then performs wave rectification and energy distribution, and wireless data decoding, such as... Figure 3 As shown, the right side contains the data coil and the energy coil. Similarly, the externally located image processing module B is electrically connected to the corresponding data coil and energy coil C. This allows data to be transmitted from the external data coil to the internal data coil, achieving wireless communication. The external and internal energy coils wirelessly power the internal electrical stimulation control module, as shown. Figure 2 As shown in the figure, A is the image acquisition module, B is the image processing module, and C is the coil module.

[0053] In practice, the electrical stimulation uses a specific waveform stimulation from a constant current source. The flexible electrode of each channel can be independently controlled by the electrical stimulation control module. The number of channels ranges from a few to thousands. The electrical stimulation parameters include amplitude, duty cycle, waveform, interval, waveform frequency, and waveform interval.

[0054] In specific implementation, the electrical stimulation control module is set with a minimum current and a maximum current for electrical stimulation, wherein the minimum current is not less than 1uA and the maximum current is not more than 5mA.

[0055] The actual value of the minimum current is determined based on the waveform of nerve emission collected by the adjacent electrode to determine the minimum threshold current of the nerve response; or by animal behavior, human patients' photophantom perception, and visual quality assessment reports to determine the minimum threshold current of the effective stimulus.

[0056] The safe value of the maximum current is determined by significant changes in biomarkers of brain nerve damage and brain inflammation caused by electrical stimulation over a period of time.

[0057] The specific method for determining the minimum current for a neural response is as follows: after electrical stimulation, for a period of time (usually on the order of milliseconds), the influence of electrical stimulation artifacts is removed before analysis. If a clear electrical stimulation response waveform can be recorded at adjacent electrodes, it is considered to have exceeded the neural response threshold.

[0058] The minimum current is the response threshold of the nerve cell, and the maximum current is the safe upper limit of the nerve cell.

[0059] The method of electrical stimulation is as follows: gradually increase the stimulation current at each electrode point, starting from 1uA, and gradually increasing it in different current increments until the safe threshold (maximum current) for electrical stimulation is reached, generally not exceeding 5mA, depending on the electrode size, morphology, and specific electrical stimulation strategy. Within a safe and effective range, various electrical stimulation parameters are changed, including but not limited to amplitude, duty cycle, waveform, interval, waveform frequency, and waveform spacing.

[0060] The electrical stimulation control module has a built-in overcurrent / overvoltage protection module. When the current exceeds 5mA or the electrode impedance rises abnormally, the stimulation will automatically stop. It can use a biphasic pulse waveform (positive phase + negative phase, generally with the negative phase preferred) and ground the stimulator every once in a while to avoid the accumulation of charge in the brain tissue and reduce the risk of electrochemical corrosion of the electrodes and nerve damage.

[0061] In specific implementation, the biomarkers of brain nerve damage include, but are not limited to, neuron-specific enolase NSE, calcium-binding protein S100B, neurofilament light chain NfL, etc.; the biomarkers of brain inflammation include, but are not limited to, IL-1β, IL-6, IL-8, IL-17, IFN-γ, TNF-α, etc.

[0062] Of course, other similar biomarkers can also be collected for these markers of brain nerve damage and brain inflammation.

[0063] In practice, after patients or animals are electrically stimulated, visual-related neuroprotective and neural remodeling biomarkers include, but are not limited to: brain-derived neurotrophic factor (BDNF), glial cell-derived neurotrophic factor (GDNF), growth-associated protein (GAP-43), nerve growth factor (NGF), fibroblast growth factor (FGF-2), synaptic protein (Synapsin I), and glial fibrillary acidic protein (GFAP). These biomarkers require several hours to several days after electrical stimulation to be expressed. Other similar biomarkers can also be collected.

[0064] In specific implementation, the stimulation effect evaluation module includes:

[0065] The acquisition unit is used to collect biological samples from the patient at several time points during three stages: before implantation of the electrical stimulation control module, after implantation of the electrical stimulation control module and before electrical stimulation, and after electrical stimulation. These biological samples include, but are not limited to, cerebrospinal fluid, blood, saliva, tears, urine, etc.

[0066] The detection unit, after conventional sample pretreatment, uses methods such as electrochemiluminescence, single-molecule detection, flow cytometry, or adjacent extension technology to quantitatively detect the concentration of one or more biomarkers, thereby assessing neuro-related biochemical activities after brain implantation.

[0067] Considering accuracy and technological development trends, single-molecule detection methods are preferred.

[0068] Due to the blood-brain barrier, most biomarkers induced by electrical stimulation of the visual cortex in the brain are present at extremely low concentrations in the blood, typically in the range of fg / mL to pg / mL, close to or below the limits of traditional immunoassay devices, and are difficult to measure accurately. Furthermore, for detecting changes in the concentration of small molecules such as neurotransmitters and hormones, competitive methods are required instead of the mainstream double-antibody sandwich method. Therefore, detecting biomarkers before and after electrical stimulation in blood or even saliva generally requires highly sensitive detection methods, including but not limited to electrochemiluminescence, single-molecule immunoassay, flow cytometry, and PEA (ortho-extension technique). Sample pretreatment must be performed according to the requirements of different methodologies. Among these, single-molecule detection is recognized for its ultra-high sensitivity and absolute quantification capability, making it the preferred platform for blood and saliva testing.

[0069] In specific implementation, the stimulation effect evaluation module also includes ophthalmic equipment and scales, which are used to examine the patient's visual acuity, visual evoked potentials and other physiological indicators.

[0070] The ophthalmic equipment and scales can include fundus cameras, ophthalmic OCT, visual cortical potentials (VEP), electroretinography (ERG), electroencephalography (EEG) signals, eye movement tracking, fMRI, ophthalmic equipment, and electroencephalograms (EEGs).

[0071] Take monkeys as an example, such as Figure 5 and Figure 6 As shown, in Figure 5 The diagram shows the implantation of the electrical stimulation control module in a monkey. The top part is a coil on the dura mater, the bottom part is a flexible electrode inserted under the dura mater, closely attached to the visual cortex V1, and the middle part is the rigid material package of the electrical stimulation control module chip (ceramic substrate + titanium cap). Figure 6 The flexible electrode is attached to the surface of the V1 visual cortex of a monkey and has 128 channels.

[0072] Taking monkey blood sample collection as an example, blood samples were collected three times: 7 days before implantation, 3 days after implantation, and on the day of implantation. Five blood samples were collected on days 2, 7, 10, 14, and 21 after implantation. Five blood samples were collected on days 2, 7, 14, 21, and 42 after electrical stimulation. Blood samples were mixed immediately after collection, incubated at 4°C for 15-30 minutes, centrifuged at 3000 rpm for 15 minutes, and the supernatant was aliquoted. Samples collected on the same day were analyzed using a single-molecule detection system, and remaining samples were stored at -80°C. Considering both safety and efficacy, the following biomarkers were selected for single or multiple detection: interleukin-6 (IL-6), TNF-α, brain-derived neurotrophic factor (BDNF), neuron-specific enolase (NSE), and glial fibrillary acidic protein (GFAP). The electrical stimulation parameters can be adjusted based on the biomarkers.

[0073] In summary, the visual closed-loop diagnosis and treatment system based on electrical stimulation provided in this application can change the stimulation parameters of the waveform generator through the external image acquisition module and the communication module of the implant, based on the quantitative values ​​of the stimulation effect evaluation module, making electrical stimulation safer and more effective, thereby achieving the purpose of closed-loop feedback adjustment.

[0074] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0075] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A visual closed-loop diagnostic and treatment system based on electrical stimulation, characterized in that, include: Image acquisition module, which is used to acquire external video image information; The image processing module is used to process and encode the received video image information into a specific neural electrical stimulation encoded signal and send it to the electrical stimulation control module; An electrical stimulation control module is compliantly attached to the visual cortex of a patient or animal's brain. It is used to further process the received neural electrical stimulation encoded signals, output corresponding electrical stimulation parameters, and control the corresponding flexible electrodes to output electrical signals to stimulate nerve cells. The stimulation effect evaluation module is used to collect the patient's biomarker concentrations and evaluate the safety and effectiveness of electrical stimulation after data analysis.

2. The visual closed-loop diagnostic and treatment system based on electrical stimulation according to claim 1, characterized in that, The electrical stimulation control module includes a waveform generator integrating a neurostimulator integrated circuit and peripheral components, a communication submodule for receiving energy and neurostimulation encoded signals, and an encapsulation submodule that covers the waveform generator and meets implantable biocompatibility requirements. The packaged submodule includes a packaged substrate with multiple metal wires on it. One end of each metal wire is connected to multiple pins of a waveform generator, and the other end is connected to a multi-channel flexible electrode, so that each independent output pin of the waveform generator is connected to each channel of the flexible electrode. The stimulation electrode point at the other end of the flexible electrode is closely attached to the surface of the visual cortex of the brain.

3. The visual closed-loop diagnostic and treatment system based on electrical stimulation according to claim 2, characterized in that, The waveform generator uses a specific waveform stimulation from a constant current source. The flexible electrode points of each channel can be independently controlled by the electrical stimulation control module. The electrical stimulation parameters include amplitude, duty cycle, waveform, interval, waveform frequency, and waveform interval.

4. The visual closed-loop diagnostic and treatment system based on electrical stimulation according to claim 2, characterized in that, The communication submodule obtains power supply and nerve stimulation encoded signals via wired means or via radio waves, and then the waveform generator performs radio wave rectification and energy distribution, and wireless data decoding.

5. The visual closed-loop diagnostic and treatment system based on electrical stimulation according to claim 2, characterized in that, The electrical stimulation control module is set with a minimum current and a maximum current for electrical stimulation, wherein the minimum current is not less than 1uA and the maximum current is not more than 5mA. The actual value of the minimum current is determined based on the waveform of nerve emission collected by the adjacent electrode to determine the minimum threshold current of the nerve response; or by animal behavior, human patients' photophantom perception, and visual quality assessment reports to determine the minimum threshold current of the effective stimulus. The safe value of the maximum current is determined by significant changes in biomarkers of brain nerve damage and brain inflammation caused by electrical stimulation over a period of time.

6. The visual closed-loop diagnosis and treatment system based on electrical stimulation according to claim 2, characterized in that, The markers of brain nerve damage include neuron-specific enolase NSE, calcium-binding protein S100B, and neurofilament light chain NfL. The biomarkers of brain inflammation include IL-1β, IL-6, IL-8, IL-17, IFN-γ, and TNF-α.

7. The visual closed-loop diagnostic and treatment system based on electrical stimulation according to claim 2, characterized in that, Markers of visual-related neuroprotection and neural remodeling in patients or animals after electrical stimulation include brain-derived neurotrophic factor (BDNF), glial cell-derived neurotrophic factor (GDNF), growth-associated protein (GAP-43), nerve growth factor (NGF), fibroblast growth factor (FGF-2), synaptic protein (Synapsin I), and glial fibrillary acidic protein (GFAP).

8. The visual closed-loop diagnostic and treatment system based on electrical stimulation according to claim 2, characterized in that, The stimulation effect evaluation module includes: The collection unit is used to collect biological samples from patients or animals at several time points in three stages: before implantation of the electrical stimulation control module, after implantation of the electrical stimulation control module, before electrical stimulation, and after electrical stimulation. The biological samples include cerebrospinal fluid, blood, saliva, tears, and urine. The detection unit, after the biological sample has undergone conventional sample pretreatment, uses electrochemiluminescence, single-molecule detection, flow cytometry, or adjacent extension techniques to quantitatively detect the concentration of one or more biomarkers, thereby assessing neuro-related biochemical activities after brain implantation.

9. The visual closed-loop diagnostic and treatment system based on electrical stimulation according to claim 8, characterized in that, The stimulation effect evaluation module also includes: Ophthalmic equipment and scales used to examine a patient's visual acuity and visual evoked potentials.

10. The visual closed-loop diagnostic and treatment system based on electrical stimulation according to claim 8, characterized in that, Based on the quantitative values ​​from the stimulation effect evaluation module, the stimulation parameters of the waveform generator are changed through the external electrical stimulation control module and communication sub-module, making the electrical stimulation safer and more effective, thereby achieving the purpose of closed-loop feedback adjustment.

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