Medical equipment for treating diseases by inducing and adjusting controllable delivery of liquid

Abstract

The invention relates to medical equipment for treating diseases by inducing and regulating controllable liquid delivery, which comprises a computer program module, an electrode system device and a control unit and is used for treating diseases related to the central nervous system and / or the cerebrospinal fluid system. , including but not limited to encephaledema, encephalitis, stroke, brain trauma, brain tumor, intracerebral hemorrhage, Alzheimer's disease, Parkinson's disease, and other applications, including but not limited to drug delivery. According to the working principle, two or more electrodes placed at selected positions in the head and / or the brain of a patient are used for electroosmosis treatment, and controllable transmission of fluid in a central nervous system / cerebrospinal fluid system of the patient is induced and adjusted in an electroosmosis flow mode. The method is realized through the following mechanisms: (1) inducing and regulating liquid flow in a central nervous system / cerebrospinal fluid system; (2) regulating neuroplasticity and exciting / inhibiting polarization; and (3) brain wastes such as harmful proteins and particles in the central nervous system / cerebrospinal fluid system are guided and removed.

Description

Technical Field

[0001] The present invention relates to a medical device for treating the central nervous system (CNS) and / or cerebrospinal fluid (CSF) system, which is suitable for a variety of uses, including but not limited to the treatment of central nervous system-related diseases, including but not limited to cerebral edema, encephalitis, stroke, brain trauma, brain tumors, cerebral hemorrhage, Alzheimer's disease, Parkinson's disease, and other applications, including but not limited to drug delivery. The present invention particularly relates to a medical device for treating diseases by inducing and regulating the controllable delivery of liquid in the central nervous system and / or cerebrospinal fluid (CNS / CSF) system through electroosmotic flow, and the medical device achieves the above-mentioned purpose through the following main mechanisms: (1) inducing and regulating the flow of liquid in the central nervous system / cerebrospinal fluid system; (2) regulating neural plasticity and excitation / inhibition polarization; (3) guiding and clearing brain wastes such as harmful proteins and particles in the central nervous system / cerebrospinal fluid system. Background Art

[0002] The statements in this section merely provide background art related to the present invention and do not necessarily constitute prior art.

[0003] Brain edema refers to the increase in water content in neural tissue and is a major neurological complication of brain trauma, stroke, encephalitis, brain tumors and intracerebral hemorrhage. Most patients with brain edema experience increased intracranial pressure, which may worsen if not effectively treated. Intracerebral hemorrhage, also known as hemorrhagic stroke, is a sudden bleeding in the brain parenchyma and / or ventricles. Unless effectively treated, it is life-threatening and requires immediate medical attention. Intracerebral hemorrhage can limit oxygen supply to the brain and cause headaches, nausea, vomiting, tingling in the limbs or facial paralysis. The enlargement of the hematoma is the main cause of early neurological deterioration. Within three hours of the onset of intracerebral hemorrhage, up to 38% of hematomas will expand, and the volume of the hematoma is an important indicator for predicting 30-day mortality. Alzheimer's disease is a progressive disease that begins with mild memory loss and may lead to loss of the ability to talk and respond to the environment. It is the leading cause of dementia and is rapidly becoming one of the most expensive, deadly and burdensome diseases of this century. Parkinson's disease is a brain disease that causes unintentional or uncontrollable movements such as tremors, rigidity, and difficulty with balance and coordination. It is a chronic degenerative disease of the central nervous system, primarily affecting the motor system.

[0004] Currently, cerebral edema is usually treated with corticosteroids or osmotic diuretics. In particular, osmotic therapy has been regarded as the mainstream of drug treatment, but it may cause side effects such as acute renal failure and reduced cerebral perfusion. In addition, when the mass effect of cerebral edema is too high and cannot be controlled by osmotic therapy alone, neurosurgical treatment (such as decompressive craniotomy) is the final option for patients with the most severe brain trauma and stroke, with the aim of reducing the intracranial pressure caused by cerebral edema. Decompressive craniotomy does reduce mortality, but it increases the survival rate of patients with severe disability, and some patients may even become vegetative, which may be due to severe stretching of the brain tissue inside and the bony edge. The focus of treating cerebral hemorrhage is to stop bleeding, remove blood clots, and relieve brain pressure. At present, there is no specific therapy that can improve the prognosis after hemorrhage. Although recombinant factor VIIa can limit the expansion of hematoma, the results of early phase III studies showed that there was no reduction in severe disability or mortality after 90 days. Alzheimer's is a complex disease. There is currently no cure for Alzheimer's, but there are medications that can temporarily reduce symptoms. Galantamine, rivasamine, and donepezil are all cholinesterase inhibitors that can be used to treat mild to moderate Alzheimer's symptoms. These medications can help reduce or control certain cognitive and behavioral symptoms. Parkinson's disease is a rapidly growing neurodegenerative disease. Levodopa is the most commonly used first-line treatment. However, Parkinson's disease currently has no cure. Currently, no treatment can slow or stop the progression of Parkinson's disease. However, new understanding of the genetic causes and mechanisms of neuronal death has provided the basis for several promising disease-modifying strategies being tested. The best treatment needs to be tailored to the individual patient and adjusted as the disease progresses.

[0005] Therefore, despite improvements in treatment over the past few decades, some diseases related to the central nervous system, including cerebral edema, cerebral hemorrhage, Alzheimer's disease and Parkinson's disease, still have no clear and successful treatment. For diseases such as cerebral hemorrhage, Alzheimer's disease and Parkinson's disease, an effective method is needed to relieve brain edema and fluid accumulation and remove waste products such as harmful proteins and blood clots from the central nervous system.

[0006] In US2014 / 032412 and US2017 / 0274207, a method of electroosmotically driving fluid for treating hydrocephalus is described, wherein two insulated electrodes are implanted in the brain and fluid is driven to flow between the first and second electrodes based on a capacitance-based current. The disadvantage of this invasive method through implanted electrodes is the increased risks associated with implantation and system operation, and the potential for secondary damage to the brain near the implanted electrodes. In addition, the induced fluid flow is driven by the capacitive current of the insulated electrodes. The disadvantage is that the capacitive current induced by the insulated electrodes results in uncertain effectiveness and efficiency, especially when inducing fluid flow to move fluid over a distance of more than a few centimeters.

[0007] US2019 / 0076653 describes a method for reducing the aggregation of substances such as amyloid beta protein and / or tau protein in the brain using three electrodes. In this patent, substances are driven from the brain parenchyma into the brain space filled with cerebrospinal fluid and then into the superior sagittal sinus according to the principles of electrophoresis and electroosmosis. The average amplitude of the direct current is at least 1mA and not more than 5mA, or the average amplitude is less than 1.2V. However, the invasive method of implanting electrodes has a disadvantage that it may cause secondary damage to the brain near the implanted electrodes. In addition, such an amplitude may cause electrolysis around the implanted electrodes, thereby damaging the brain.

[0008] In US9616221, a method of treating a subject determined to be at risk for or suffering from Alzheimer's disease by driving fluid from the subarachnoid space to the superior sagittal sinus via electroosmosis is described. The midface treatment electrode is located above the superior sagittal sinus and the lateral treatment electrode is located between 1 and 12 cm on the midsagittal plane of the skull. However, this electrode configuration is used to drive fluid from the subarachnoid space to the superior sagittal sinus. Although this affects the superficial gray matter of the brain, it has little or no effect on the deep white matter. The disadvantage of setting the treatment electrode in a fixed position rather than adjusting the electrode position based on the location of the fluid source in the patient's head is that it is impossible to achieve controllable fluid delivery in the central nervous system and / or cerebrospinal fluid system.

[0009] In US11413455B1, a method for treating a subject determined to be at risk for or suffering from Alzheimer's disease by removing amyloid beta protein, tau protein and / or metal ions from the brain parenchyma to the subarachnoid space is described. However, the central electrode is arranged only within one centimeter of the sagittal midplane of the skull, which limits the removal path and reduces the concentration and efficiency of waste removal.

[0010] In patent SE543899C2, a medical device is described for inducing controlled fluid transport in a patient's CNS / CSF system by electroosmotic flow, wherein the cathode is always placed in the superior sagittal sinus. Fluid is transported from the anode to the cathode to the superior sagittal sinus and the ventricular system.

[0011] The present invention advances the prior art in the following aspects: (1) The present invention describes a method and apparatus for driving fluid from target tissue to adjacent central nervous system regions and / or cerebrospinal fluid-filled spaces through a newly designed electrode system; (2) The newly designed electrode system can improve the focus and effectiveness of treatment; (3) The present invention can both control fluid movement and regulate neural plasticity and excitatory / inhibitory polarization; (4) The current used for treatment can be direct current or alternating current. The use of direct current can achieve continuous stimulation, intermittent treatment, or hammer-type stimulation, and improve efficiency through higher speed. In addition, the present invention also proposes to use existing equipment to supplement existing therapies to enhance the treatment of central nervous system-related diseases such as cerebral hemorrhage, Alzheimer's disease and Parkinson's disease from two aspects: (1) The novelty lies in combining with drugs. After the drugs break down large molecular proteins and / or blood clots, the device will regulate the waste released by drug treatment by guiding / clearing brain waste; (2) The novelty lies in complementing with deep brain stimulation electrodes (DBS), by coupling current equipment to improve the treatment efficiency of edema, hematoma, Alzheimer's disease and Parkinson's disease, where the DBS electrode can be set as an anode or a cathode.

[0012] Therefore, there is a need for an improved method to control or regulate fluid flow in the central nervous system, which method can be widely used to treat various neurological diseases, including but not limited to the treatment of cerebral edema, cerebral hemorrhage, Alzheimer's disease, Parkinson's disease, etc. In addition, the method of inducing fluid flow in the central nervous system is suitable for a variety of uses, including but not limited to drug delivery. Summary of the invention

[0013] In order to solve the technical problems existing in the above-mentioned background technology, the present invention provides a medical device for treating diseases by inducing and regulating the controllable delivery of liquid, which can alleviate the above-mentioned problems and other problems.

[0014] In a first aspect, the present invention provides a medical device for treating diseases by inducing and regulating controlled fluid delivery, which is used to induce and regulate controlled fluid transport in a patient's CNS and / or CSF system by electroosmosis through two or more electrodes placed at selected locations in the patient's head and / or brain. The medical device receives electroosmosis information, i.e., a fluid transport response generated after applying a specific potential and / or current to specific electrode locations inside the patient's head and / or brain based on an individualized three-dimensional head model of the patient, receives a fluid source location in the patient's head, selects a group of electrode locations using the electroosmosis information and the fluid source location, electrically communicates two or more electrodes with the central nervous system / cerebrospinal fluid system, places each electrode at one of the selected electrode locations, and controls the application of a selected potential and / or current to the electrodes, wherein the selected potential and / or current is selected as the potential and / or current associated with the selected electrode location through the electroosmosis information to induce and regulate controlled fluid transport in the central nervous system / cerebrospinal fluid system.

[0015] In a second aspect of the present invention, there is provided a medical device for treating diseases by inducing and regulating controlled fluid transport, wherein electroosmosis is used to induce and regulate controlled fluid transport in the central nervous system and / or cerebrospinal fluid system by two or more electrodes placed at selected locations on the patient's head and / or brain. The medical device is configured as follows:

[0016] a) receiving information about electrode positions and / or about electrode potentials and / or electrode currents to achieve controlled fluid transport in the CNS / CSF system, wherein the information is generated by computer simulation of induced fluid transport in a computer model of the CNS / CSF system; the computer model is generated based on a set of medical images of the CNS / CSF system, the simulation being performed by simulating the fluid transport response resulting from the application of potentials and / or currents to at least one simulated anode and at least one simulated cathode in the computer model that are in electrical communication with the CNS / CSF system;

[0017] b) placing at least two electrodes in electrical communication with the central nervous system / cerebrospinal fluid system, and

[0018] c) Based on the information received from the computer simulation, controlling the application of electric potential and / or current to the electrodes by a control unit to induce and modulate controlled fluid transport in the central nervous system / cerebrospinal fluid system, and / or modulate neural plasticity and excitatory / inhibitory polarization.

[0019] Preferably, the medical device includes at least one electrode acting as a cathode and at least one electrode acting as an anode placed at locations corresponding to simulated cathode / anode locations. Any electrode can be configured as an anode or cathode as desired. Each electrode is designed to perform electrical stimulation and detect various indicators, such as brain signals and intracranial pressure.

[0020] Preferably, the medical device comprises applying an electrical potential and / or current to electrodes placed at positions corresponding to simulated cathode / anode positions.

[0021] Preferably, the medical device includes applying a potential and / or current to the electrodes corresponding to the simulated potential and / or current applied to the simulated electrodes. The applied current for treatment may be direct current or alternating current, thereby providing continuous stimulation, intermittent treatment or hammer stimulation to the patient.

[0022] Preferably, the medical device comprises controlling the application of electric potential and / or current to said electrodes based on at least one simulation result in information received from a computer simulation.

[0023] According to one embodiment, the medical device selects a central nervous system / cerebrospinal fluid system region to be drained of fluid and selects a central nervous system / cerebrospinal fluid system region to be received of fluid, and the step b) performed by the medical device comprises:

[0024] b1) placing at least one cathode in electrical communication with the CNS / CSF system behind and / or within the area to receive the fluid, as viewed from the area to be drained, and

[0025] b2) placing at least one anode in electrical communication with the CNS / CSF system at a spaced location behind and / or within the area where the fluid is to be drained, as viewed from the area where the fluid is to be received.

[0026] The area receiving the fluid is preferably an adjacent CNS / CSF area, such as the brain parenchyma. The area receiving the fluid is preferably an area filled with cerebrospinal fluid and / or interstitial fluid, such as the subarachnoid space, superior sagittal sinus, ventricular system, etc.

[0027] In one embodiment, the method performed by the medical device includes selecting a passage area of ​​the CNS / CSF system. The passage area preferably includes an area located between an area to be drained and an area to be received, and the area forms a preferred passage for fluid flow between the latter two areas.

[0028] In one embodiment, the method performed by the medical device includes selecting a preferred path to drive fluid from a source region to a surrounding healthy brain region proximate to the source region.

[0029] In one embodiment, a method performed by a medical device includes selecting a preferred path to drive fluid from a source region to an adjacent cerebrospinal fluid-filled space.

[0030] In one embodiment, the method step c) performed by the medical device comprises:

[0031] c1) applying an electric potential and / or current to at least one cathode and at least one anode by controlling the control unit so as to centrally transport the fluid from the selected fluid discharge area to the selected fluid receiving area;

[0032] c2) using a control unit to control the application of electric potential and / or current to at least one cathode and at least one anode to regulate neural plasticity and excitatory / inhibitory polarization.

[0033] The fluid is transported from the area to be drained to the area for receiving the fluid, thereby reducing the accumulation of edema fluid and ions at the fluid source location in patients with cerebral edema and / or hematoma. The fluid is transported from the area to be drained to the area receiving the fluid and concentrated to the selected pathway to remove waste products in the controlled fluid, such as blood clots, amyloid beta protein, tau protein and / or metal ions, which is suitable for patients with cerebral hemorrhage, Alzheimer's disease and / or Parkinson's disease. The fluid transport from the area to be drained to the area receiving the fluid is concentrated on the selected pathway, thereby pushing the drug in the controlled fluid to the target area and achieving focusing during the treatment process. In addition, electrical stimulation can also be used to regulate neuroplasticity and excitation / inhibition polarization by placing two or more electrodes at selected locations on the patient's head and / or brain.

[0034] According to the third aspect of the present invention, there is provided a medical device for treating diseases by inducing and regulating controlled fluid transport, wherein two or more electrodes are placed at selected locations on the patient's head and / or inside the brain, and electroosmosis is used to induce and regulate controlled fluid transport in the CNS / CSF system to supplement existing therapies, thereby enhancing the treatment of central nervous system-related diseases such as cerebral edema, cerebral hemorrhage, Alzheimer's disease, Parkinson's disease, etc.

[0035] In one embodiment, the medical device is suitable for treating various diseases characterized by accumulation of edema fluid, including but not limited to brain edema, encephalitis, stroke, brain trauma, brain tumor, and cerebral hemorrhage. The medical device can supplement current edema treatments, for example, supplement hyperosmotic treatments of edema to improve its efficiency. The medical device can cause excess fluid in the edema area to flow dispersedly into adjacent brain tissue, and then absorb the excess fluid from the brain parenchyma into the intravascular space through hyperosmotic therapy.

[0036] In one embodiment, the method performed by the medical device is suitable for treating various diseases characterized by the accumulation of central nervous system-related waste products, including harmful proteins and blood clots that occur in various neurodegenerative diseases, including but not limited to cerebral hemorrhage, Alzheimer's disease, and Parkinson's disease.

[0037] In one embodiment, the medical device can remove / direct brain waste after the drug breaks it down into small pieces, thereby supplementing existing therapies for brain hemorrhage, Alzheimer's disease, and Parkinson's disease. Blood clots and larger brain waste products (such as amyloid beta protein and tau protein) are broken down into powder or smaller particles using drugs. Then, a fluid including the powder or small particles is delivered to the cerebrospinal fluid-filled space near the lesion.

[0038] In one embodiment, the medical device can complement existing therapies for treating brain hemorrhage, Alzheimer's disease, and Parkinson's disease by coupling with invasive electrodes such as existing deep brain stimulation (DBS) electrodes. The existing DBS electrodes can be set as anodes and the electrodes in the medical device can be set as cathodes to remove brain waste and / or blood clots by driving fluid into the cerebrospinal fluid-filled space, thereby achieving more effective treatment by combining the synergistic effect of deep brain stimulation and brain waste removal.

[0039] Through the following detailed description of one or more embodiments, those skilled in the art will have a more comprehensive understanding of the embodiments of the present invention and will recognize other advantages of the present invention.It should be understood that the same reference numerals are used to identify the same elements shown in one or more figures. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 It is a flow chart of the process of using the medical device of the present invention for individualized treatment of patients;

[0041] Figure 2A is a schematic diagram of a medical device for non-invasive treatment of central nervous system / cerebrospinal fluid system related diseases;

[0042] Figure 2B is a schematic diagram of a medical device used for invasive treatment of central nervous system / cerebrospinal fluid system related diseases;

[0043] Figure 3 yes Figure 2A A schematic diagram of one of the electrode configurations;

[0044] Figure 4 yes Figure 2A A schematic diagram of one of the electrode configurations;

[0045] Figure 5 yes Figure 2A A schematic diagram of one of the electrode configurations;

[0046] Figure 6 yes Figure 2A A schematic diagram of one of the electrode configurations;

[0047] Figure 7 yes Figure 2A A schematic diagram of one of the electrode configurations;

[0048] Figure 8 yes Figure 2A A schematic diagram of one of the electrode configurations;

[0049] Fig. 9 yes Figure 2A A schematic diagram of one of the electrode configurations;

[0050] Fig.10 yes Figure 2A A schematic diagram of one of the electrode configurations;

[0051] Fig.11 yes Figure 2A A schematic diagram of one of the electrode configurations;

[0052] Fig.12 yes Figure 2B A schematic diagram of one of the electrode configurations;

[0053] Fig.13 is a flow chart of a method performed by a medical device in treating a patient.

[0054] Through the following detailed description of one or more embodiments, those skilled in the art will have a more comprehensive understanding of the embodiments of the present invention and will recognize other advantages of the present invention.It should be understood that the same reference numerals are used to identify the same elements shown in one or more figures. DETAILED DESCRIPTION

[0055] In the present disclosure, the term "lymphoid flow" refers to the flow of fluid in the lymphoid system and / or lymphoid clearance pathways and / or vascular bypass systems.

[0056] In the present disclosure, the term "target tissue" refers to a diseased area in the CNS / CSF system. In other words, the diseased area is caused by brain edema, cerebral hemorrhage, Alzheimer's disease, Parkinson's disease or other CNS-related diseases related to fluid flow inside the CNS / CSF system. The term "target tissue" can be used interchangeably with target area or fluid source.

[0057] In the present disclosure, the term "brain waste" refers to useless substances and toxic metabolic byproducts / interstitial wastes, such as lactate, metal ions, proteins (including amyloid β (Aβ) protein and tau protein, etc.).

[0058] In the present disclosure, the term "regulating lymphoid fluid flow" means changing / regulating the direction or speed of lymphoid fluid flow, and is used interchangeably with "modifying lymphoid fluid flow" or "altering lymphoid fluid flow".

[0059] In this disclosure, the term "electroosmosis" may be used interchangeably with electroosmotic flow, electroosmosis, or electroendosmosis to refer to the movement of a fluid induced by an applied electric potential through a porous material or any other fluid conduit.

[0060] In the present disclosure, the term "patient-individualized three-dimensional head model" refers to a model that is capable of providing a fluid transfer response given input parameters (such as selected potentials and / or currents applied to selected electrode locations on the patient's head). In other words, the fluid transfer response represents controlled fluid transfer in the central nervous system / cerebrospinal fluid system. In the present disclosure, the terms "computer model", "computer model of the CNS / CSF system" and "patient-individualized three-dimensional head model" can be used interchangeably. The patient-individualized three-dimensional head model may include models of how various parts of the patient's head respond to given input parameters, such as fiber structure models, skin models, skull models, body membrane models, models / information of damaged neural tissue and healthy neural tissue, brain models, cerebrospinal fluid models, ventricle models, brain white matter tissue models, brain gray matter tissue models, brain stem models, spinal cord models in the central nervous system / cerebrospinal fluid system. These models may include electrical material parameter values, such as conductivity and / or dielectric constant.

[0061] In the present disclosure, the term "medical image" refers to the output / result of an imaging system used on and for a patient's head, such as a set of computed tomography (CT) images and / or a set of multimodal medical images, such as magnetic resonance imaging (MRI) images and / or diffusion tensor imaging (DTI) images and / or ultrasound images and / or positron emission tomography (PET) images.

[0062] In this disclosure, the term "hammering stimulation" refers to the delivery of an electrical potential / current in a pulsed manner of a specific amplitude and frequency, thereby producing a repetitive and rhythmic pulse stimulation pattern. The magnitude and frequency of the electrical potential / current are intended to produce an effect similar to "hammering" with the goal of increasing the induced fluid transport rate of current medical devices; in addition, the increased mechanical force during hammering may open the blood-brain barrier (BBB), facilitating enhanced drug delivery and therapeutic interventions.

[0063] In this disclosure, when used to describe electrode positioning, the term "posterior" refers to a relative position along the surface of the patient's head. In other words, it is the position where a straight line from the fluid target location through the fluid source location intersects the surface of the patient's head.

[0064] According to one aspect, the present invention relates to fluid delivery in the central nervous system and / or central nervous system-related diseases, such as drug delivery, cerebral edema, cerebral hemorrhage, Alzheimer's disease, Parkinson's disease, and treatment based on the electroosmotic properties of tissues, when electrodes are applied to the patient's head, fluid can be directed from one area to an adjacent central nervous system / cerebrospinal fluid area.

[0065] In some embodiments, an electrode system device developed for treating a disease is used. Figure 2A and Figure 2B ). The electrode system device can apply specific potentials and / or currents at specific or predefined electrode locations on the patient's head.

[0066] The mechanism behind the present invention is the electroosmotic property of the brain: electroosmotic flow can be induced by the electric field of an applied electrode. By activating the electrodes in a designed manner, the present invention can induce and regulate fluid flow in the central nervous system / cerebrospinal fluid system, and is expected to be used to treat various types of central nervous system-related diseases, including brain edema, cerebral hemorrhage, Alzheimer's disease and Parkinson's disease. The present disclosure can also be used to change / regulate the flow of glymphatic fluid and / or interstitial fluid to achieve directional drug delivery. By activating the electrodes according to the simulation results of the patient's individualized three-dimensional head model, the present disclosure can focus treatment on the desired tissue area and guide the fluid to flow along a preferred path to avoid unnecessary interference with the relatively healthy brain. The present disclosure allows treatment of local target tissue or the entire brain by driving the fluid to flow directional from the target area to the adjacent CNS / CSF area, such as the adjacent brain parenchyma to achieve brain fluid self-circulation, or to the subarachnoid space to achieve cerebrospinal fluid circulation, or to the ventricular system to achieve cerebrospinal fluid circulation. Brain fluid entering the cerebrospinal fluid circulation will be absorbed by the superior sagittal sinus. For patients with cerebral edema, the fluid in the edematous tissue can be directed to the adjacent brain parenchyma to allow the cerebral fluid to circulate naturally, or to the subarachnoid space and / or the ventricular system to be absorbed into the superior sagittal sinus, thereby alleviating the edema. For patients with hematoma, the effusion in the target tissue can be directed to the adjacent brain parenchyma to allow the cerebral fluid to circulate naturally, or to the subarachnoid space and / or the ventricular system to be absorbed into the vascular system of the brain, thereby alleviating the hematoma. For patients with Alzheimer's disease or Parkinson's disease, the fluid in the target tissue is directed to the subarachnoid space or the ventricular system, causing waste products in the controlled fluid, such as amyloid β protein, tau protein and / or metal ions, to flow together under the action of viscous resistance and then be cleared by the cerebrospinal fluid circulation. For patients with cerebral hemorrhage, the fluid in the target tissue is directed to the subarachnoid space or the ventricular system, causing blood clots to flow together under the action of viscous resistance and then be cleared by the cerebrospinal fluid circulation. In terms of drug delivery, the liquid is directed to the diseased area by activating the electrodes, so that the drugs dispersed in the liquid move together under the action of viscous resistance and flow to the specific area.

[0067] Electrical stimulation can modulate neural plasticity and excitatory / inhibitory polarization to achieve better results. Anode stimulation is thought to promote neuronal depolarization, while cathode stimulation causes hyperpolarization, which inhibits neuronal depolarization. In addition, electrical stimulation affects multiple neurons, increasing their membrane potential to induce depolarization. Electrical stimulation can change the activity levels of specific brain regions and multiple network systems. Neuroplastic changes refer to the ability of neurons or brain structures to adapt and adjust the nervous system at the functional and structural levels when exposed to new experiences. Electric current can induce long-term delay (LTP) or long-term depression (LTD)-like sustainable responses of plasticity. In summary, electrical stimulation can affect local cortical plasticity and modulate subcortical and deep structures, thereby improving patient treatment outcomes. In addition, the increased mechanical force during the pulse may open the blood-brain barrier (BBB), thereby facilitating drug delivery and therapeutic intervention.

[0068] Figure 2A is a schematic diagram of an electrode system device 100 applied to a subject's head for non-invasive treatment of central nervous system-related diseases according to some applications of the present invention. Figure 2B 1 is a schematic diagram of another electrode system device 200 for invasive treatment of central nervous system-related diseases on the head of a subject according to certain applications of the present invention. The central electrode is inserted into the target tissue, such as the diseased tissue in the brain parenchyma, and the peripheral electrodes are placed on the surface of the subject's head. The electrode system device 100 and the other electrode system device 200 are respectively composed of 10-100 electrodes, each of which can be set as an anode or a cathode according to the design method. Each electrode can be used to perform electrical stimulation and detect various indicators, such as brain signals and intracranial pressure. The electrode system device 100 and the other electrode system device 200 also include a control unit 300 for inputting electric potential and / or current to the electrode, and a control circuit coupled to the electrode.

[0069] According to one aspect, the medical device, for treating central nervous system related diseases by utilizing the electroosmotic properties of tissue and applying electric potentials and / or currents based on patient images, is configured to:

[0070] 1) Obtain medical images of the patient, such as CT, MRI, DTI and PET, and generate a specific three-dimensional model of the patient's head, including the target tissue part, based on the medical images, and simulate it with the electrode system device through computer simulation;

[0071] 2) Select reasonable activation electrodes with optimized parameters based on the simulation results of the patient's individualized three-dimensional model;

[0072] 3) The electrode system assembly is mounted on the patient's head and the selected electrodes are activated to drive edema fluid flow from the target tissue area to adjacent brain tissue or cerebrospinal fluid-filled spaces and / or modulate neural plasticity and excitatory / inhibitory polarization.

[0073] According to one embodiment, an electrode system device having electrodes at predetermined positions can be activated using different selected electrodes according to the target required by the patient's medical image. The electrode system device includes a plurality of electrodes. For example, the electrode system device may include 100 electrodes. The electrode configuration (such as distance and required current / voltage) as anode and cathode electrodes is determined according to the patient's individualized three-dimensional head model. According to the simulation results or fluid transmission response of the patient's individualized three-dimensional head model, the treatment lesion is controlled by adjusting the electrode position. According to the simulation results or the fluid transmission response of the patient's individualized three-dimensional head model, the treatment dose and duration are controlled by adjusting the amplitude of the current / voltage and the treatment time. When using the electrode system device, it includes selecting which electrodes to activate as anode and / or cathode electrodes. The method performed by the device can be used to treat central nervous system related diseases, including but not limited to cerebral edema, cerebral hemorrhage, Alzheimer's disease, Parkinson's disease, etc., and is suitable for drug delivery.

[0074] Figure 3 , Figure 4 , Figure 5 , Figure 6 , Figure 7 , Figure 8 , Fig. 9 , Fig.10 , Fig.11 According to some applications of the present invention, Figure 2A Schematic illustration of different electrode configurations of the device. Figure 3 , Figure 4 , Figure 5 , Figure 6 , Figure 7 , Figure 8 Several applications of the present invention are described for delivering fluid from local target tissues to cerebrospinal fluid-filled spaces such as the subarachnoid space and the ventricular system. Figure 3 As shown, the anode electrode array 102 and the cathode electrode array 101 are activated to guide the fluid in the target tissue 10 to the subarachnoid space adjacent to the target tissue. Figure 4 As shown, the anode electrode array 104 and the cathode electrode array 103 are activated to introduce the fluid in the target tissue 11 into the subarachnoid space adjacent to the target tissue. Figure 5 As shown, the anode electrode array 103 and the cathode electrode array 105 are activated to introduce the fluid in the target tissue 12 into the subarachnoid space adjacent to the superior sagittal sinus. Figure 6 As shown, the anode electrode array 106 and the cathode electrode array 107 are activated to guide the fluid in the target tissue 13 to the subarachnoid space adjacent to the target tissue. Figure 7 As shown, the anode electrode array 107 and the cathode electrode array 108 are activated to introduce the fluid in the target tissue 14 into the subarachnoid space adjacent to the superior sagittal sinus. Figure 8 As shown, the anode electrode array 109 and the cathode electrode array 110 are activated to direct fluid in the target tissue 15 into the lateral ventricular system.

[0075] Fig. 9 and Fig.10 Some applications of the present disclosure in whole brain fluid delivery are demonstrated. Fig. 9 As shown, the anode electrode array 111 and the cathode electrode array 112 are activated to direct fluid from the entire brain to the subarachnoid space adjacent to the superior sagittal sinus. Fig.10 As shown, the anode electrode array 112 and the cathode electrode array 111 are activated to direct fluid from the entire brain into the entire subarachnoid space.

[0076] Fig.11 is an application according to the present invention, Figure 2A Schematic diagram of the electrode configuration of the device for a patient undergoing craniotomy. The patient undergoes a decompressive craniotomy by opening the skull. The anode electrode array 113 is mounted on the surface of the target tissue, and the cathode electrode array 114 is activated to direct the fluid in the target tissue 16 into the subarachnoid space and into the cerebrospinal fluid circulation.

[0077] Fig.12 is an application according to the present invention, Figure 2B A schematic diagram of an electrode configuration of the device. The anode electrode 201 is inserted into the target tissue, and the cathode electrode array 202 is activated to guide the fluid in the target tissue 17 into the subarachnoid space and enter the cerebrospinal fluid circulation.

[0078] exist Figure 3 , Figure 4 , Figure 5 , Figure 6 , Figure 7 , Figure 8 , Fig. 9 , Fig.10 , Fig.11 and Fig.12 In the figure, only the active electrodes are shown, where the anode electrode is shown in black and the cathode electrode is shown in gray hatching. The number of anodes and cathodes is determined based on the design obtained after computer simulation of induced fluid transport in a patient-specific three-dimensional head model. According to one embodiment, the medical device can induce and regulate controlled fluid transport in the central nervous system and / or cerebrospinal fluid system through electroosmosis technology, and is configured to:

[0079] a) receiving information about electrode positions and / or electrode potentials and / or electrode currents to achieve controlled fluid transport in the CNS / CSF system, wherein the information is generated by a computer simulation of induced fluid transport in a computer model of the CNS / CSF system, the computer model being generated based on a set of medical images of the CNS / CSF system, the simulation being performed by simulating a fluid transport response resulting from an applied potential and / or current by at least one simulated anode and at least one simulated cathode in electrical communication with the CNS / CSF system in the computer model;

[0080] b) placing two or more electrodes (anode and / or cathode electrodes) in electrical communication with the CNS / CSF system, and

[0081] c) controlling, by a control unit, the application of electric potentials and / or currents to the electrodes based on information received from the computer simulation to induce and regulate controlled fluid transport in the CNS / CSF system.

[0082] According to one embodiment, the present invention includes placing two or more electrodes at positions that are in electrical communication with the central nervous system portion, and the positions of these electrodes are more than 50% consistent with the positions of corresponding simulated electrodes in the computer model. According to one embodiment, the present invention includes placing electrodes at positions that are more than 70% consistent with the positions of simulated electrodes. According to one embodiment, the present invention includes placing electrodes at positions that are more than 85% consistent with the positions of simulated electrodes. According to one embodiment, the present invention includes placing electrodes at positions that are more than 90% consistent with the positions of simulated electrodes. According to one embodiment, the present invention includes placing electrodes at positions that are more than 95% consistent with the positions of simulated electrodes. Increasing the number of electrodes can better and more finely control the electric fields and / or currents generated in the central nervous system / cerebrospinal fluid system. If the electrodes are provided at fixed positions on the equipment of the central nervous system / cerebrospinal fluid system, the probability of the electrodes appearing at the desired location can also be increased.

[0083] According to one embodiment, the method performed by the medical device includes controlling the potential and / or current so that an electrode placed in a position consistent with a simulated anode acts as an anode and an electrode placed in a position consistent with a simulated cathode acts as a cathode. According to one embodiment, the computer model includes at least two simulated electrodes, at least one of which is designated as an anode and at least one of which is designated as a cathode, and the at least two electrodes are placed in electrical communication with the central nervous system portion, at least one of which is an anode and at least one of which is a cathode.

[0084] According to one embodiment, the term "electrically communicating with..." means that at least one-tenth of the electric field emitted from the electrode penetrates into the tissue in electrical communication with it. Alternatively, the term "electrically communicating" may also mean that at least one-tenth of the current emitted from the electrode penetrates into the tissue in electrical communication with it. Preferably, at least one-third of the field strength and / or current penetrates the tissue, or at least 50% of the field strength or current penetrates the tissue. Additionally, the term "electrically communicating" may mean that the applied potential or current can affect the fluid transport of the central nervous system / cerebrospinal fluid system, thereby producing a therapeutic effect. Alternatively, the term "electrically communicating" means that the applied potential or current can cause the fluid flow density to reach at least 0.lnl / min*cm through electroosmosis. 2 Preferably, the method performed by the device includes placing electrodes on a patient in electrical communication with the patient's central nervous system / cerebrospinal fluid system.

[0085] According to one embodiment, the medical device is configured to: select a region of the CNS / CSF system from which fluid is to be drained, and select a region of the CNS / CSF system from which fluid is to be received. Step b) specifically comprises:

[0086] b1) placing at least one cathode in electrical communication with the central nervous system / cerebrospinal fluid system behind and / or within the area to receive the fluid, as viewed from the area to be drained, and

[0087] b2) placing at least one anode in electrical communication with the central nervous system / cerebrospinal fluid system at a spaced position behind and / or within the area to be drained, as viewed from the area to receive the fluid.

[0088] According to one embodiment, step c) specifically comprises:

[0089] c1) applying an electric potential and / or current to at least one cathode and at least one anode by controlling the control unit so as to centrally transport the fluid from the selected fluid discharge area to the selected fluid receiving area;

[0090] c2) using a control unit to control the application of electric potential and / or current to at least one cathode and at least one anode to regulate neural plasticity and excitatory / inhibitory polarization.

[0091] Preferably, the medical device comprises at least one first anode to at least partially cover the area of ​​the central nervous system to be discharged, and at least one second anode to at least partially cover the area of ​​the central nervous system to be discharged, wherein the first anode and the second anode constitute the first anode part and the second anode part respectively. Preferably, the medical device independently applies an electric potential and / or current to the first and second anodes. In one embodiment, the first and second electrodes have different electric potentials / current intensities. In this way, the flow direction of the fluid can be fine-tuned so that the fluid flows to a predetermined path. It is best to place at least one anode so that the electric field and / or current emitted from the anode can penetrate the area of ​​the fluid to be discharged, thereby achieving electroosmosis and causing the fluid to flow out of the area to be discharged.

[0092] According to one embodiment, the medical image is one of a CT image, a PET image, a DTI image and / or an MRI image. According to one embodiment, the set of image scans is a set of magnetic resonance images.

[0093] According to one embodiment, the apparatus / computer program module is configured to:

[0094] a1) receiving in a computer memory at least one set of images of the central nervous system / cerebrospinal fluid system,

[0095] a2) generating a computer model of the CNS / CSF system based on the received image set, and

[0096] a3) simulating, using a computer, fluid transport in the computer model of the CNS / CSF system in response to an electrical potential and / or current applied through at least one simulated anode and at least one simulated cathode in electrical communication with the CNS / CSF system.

[0097] In one embodiment, the medical device acquires a magnetic resonance image of the individual to be treated, preferably including performing multiple simulations based on the same individual model using different positions of electrodes and / or different applied potentials / currents at the electrodes. This allows a path to be selected for fluid flow so that the fluid flows safely and efficiently to the receiving area. This also allows a path to be selected for fluid flow to avoid damaging tissue. It is also possible to select a path for fluid flow to avoid secondary fluid from flowing into the side areas. The simulation is preferably performed by electroosmosis to simulate induced fluid transport within the central nervous system / central cerebrospinal fluid system, where electroosmosis is obtained by applying an electric potential and / or current that produces an electric field. This electric field and / or current can drive fluid flow through the electroosmotic process. The device preferably includes controlling fluid flow using electroosmotic induced fluid flow of the electrodes.

[0098] In one embodiment, the computer model / individualized patient three-dimensional head model includes a three-dimensional model of the central nervous system / cerebrospinal fluid system. In one embodiment, the central nervous system / cerebrospinal fluid system computer model includes information about the fiber structure within the central nervous system / cerebrospinal fluid system. The fiber structure within the brain tissue allows the fluid to flow from the direction of the applied electric field to the fiber direction. This fiber structure can be taken into account by adding the fiber structure to the computer model used to simulate fluid flow. According to one embodiment, the computer model includes a skin model. According to one embodiment, the computer model includes a bone model. Preferably, the computer model includes material electrical parameter values, such as conductivity and / or dielectric constant. According to one embodiment, the computer model includes a body membrane model. Preferably, the computer model includes fluid material parameter values, such as membrane permeability. Preferably, the computer model includes osmotic parameter values, such as salinity and / or osmotic pressure. Preferably, the simulation step c) includes simulating osmotic pressure. According to one embodiment, the computer model includes information about damaged neural tissue and healthy neural tissue. Damaged and healthy neural tissue may have different material parameters, which can be simulated in the model. Preferably, the medical device identifies and classifies damaged neural tissue and healthy neural tissue from a set of medical images. Alternatively, the medical device can receive information about damaged neural tissue and healthy neural tissue. According to one embodiment, the computer model includes a three-dimensional model of the brain, cerebrospinal fluid, ventricles, skull, and scalp. In one embodiment, the computer model of the central nervous system / cerebrospinal fluid system portion includes a model of white matter tissue and gray matter tissue. In another embodiment, the computer model includes a model of the brainstem and / or a portion of the spinal cord and adjacent bones.

[0099] According to one embodiment, the medical device places one or more anodes behind or inside the area to be drained, as viewed from the area receiving the fluid.

[0100] According to one embodiment, the central nervous system / cerebrospinal fluid system is suffering from cerebral edema, and the medical device is configured to:

[0101] - Select the edematous area as the area that needs to be drained,

[0102] - simulated fluid flow away from edema, and

[0103] - Controlling fluid delivery and applying an electrical potential and / or current to the electrodes to control fluid delivery from the edema to spaces filled with cerebrospinal fluid, such as the ventricular system and the subarachnoid space, into the cerebrospinal circulation.

[0104] According to one embodiment, the central nervous system / cerebrospinal fluid system suffers from cerebral edema, and the medical device is configured to:

[0105] - Select the edematous area as the area that needs to be drained,

[0106] - simulated fluid flow away from edema, and

[0107] - controlling fluid delivery and applying an electrical potential and / or current to the electrodes to control fluid delivery from the edema to adjacent brain tissue;

[0108] -Excess fluid from adjacent brain tissue is drawn into the intravascular space by hyperosmotic therapy.

[0109] According to one embodiment, the medical device places one or more anodes behind or inside the area to be drained, as viewed from the area receiving the fluid.

[0110] According to one embodiment, the central nervous system / central cerebrospinal fluid system suffers from a hematoma, and the medical device is configured to:

[0111] -Select the area of ​​hematoma as the area that needs to be drained,

[0112] - simulated fluid transport away from the hematoma, and

[0113] -Controlling fluid delivery and applying an electrical potential and / or current to the electrodes to control fluid delivery from the hematoma to cerebrospinal fluid-filled spaces, such as the ventricular system and subarachnoid space, into the cerebrospinal fluid circulation.

[0114] According to one embodiment, the central nervous system / cerebrospinal fluid system suffers from cerebral hemorrhage, Alzheimer's disease and / or Parkinson's disease, and the medical device is configured to:

[0115] -selecting a target tissue as the area for draining fluid,

[0116] - simulate the transport of fluid away from the target tissue, and

[0117] - Controlling fluid delivery, applying an electrical potential and / or current to the electrodes to control fluid delivery and transfer of brain waste and / or blood clots from target tissue to the cerebrospinal fluid filled space.

[0118] According to one embodiment, the central nervous system / cerebrospinal fluid system suffers from cerebral hemorrhage, Alzheimer's disease and / or Parkinson's disease and has received drug treatment, and the medical device is configured to:

[0119] -selecting a target tissue as the area for draining fluid,

[0120] -Break down large harmful proteins and / or blood clots in target tissues into powder or small particles through drug treatment,

[0121] - simulate the transport of fluid away from the target tissue, and

[0122] - Controlling fluid transport and applying electrical potentials and / or currents to the electrodes to control fluid transport and the transfer of brain waste products (such as powders or small particles) from target tissues to cerebrospinal fluid-filled spaces.

[0123] According to one embodiment, the patient with the central nervous system / cerebrospinal fluid system suffers from Alzheimer's disease and / or Parkinson's disease and has received DBS treatment, and the medical device is configured to:

[0124] -selecting a target tissue as the area for draining fluid,

[0125] - Set the DBS electrode as the anode and the selected medical device electrode as the cathode,

[0126] - simulate the transport of fluid away from the target tissue, and

[0127] - Controlling fluid transport and applying electrical potentials and / or currents to the electrodes to control fluid transport and the flow of brain waste products from target tissue to the cerebrospinal fluid-filled space.

[0128] According to one embodiment, the patient has cerebral edema and / or hematoma in the central nervous system / central cerebrospinal fluid system and has been treated with DBS, and the medical device is configured to:

[0129] -selecting a target tissue as the area for draining fluid,

[0130] - Select the DBS electrode as the anode and the electrode of the medical device as the cathode,

[0131] - simulate the transport of fluid away from the target tissue, and

[0132] - Controlling fluid delivery and applying an electrical potential and / or current to the electrodes to control fluid delivery from the target tissue to the cerebrospinal fluid-filled space.

[0133] According to one embodiment, the CNS / CSF system suffers from a CNS-related disease and requires drug treatment through the BBB, and the medical device is configured to:

[0134] -Select the diseased tissue as the area to receive the drug,

[0135] - placing the anode close to the target tissue and the cathode away from the target tissue, and

[0136] -Control fluid transport and apply potential and / or current to electrodes to promote drug delivery across the BBB to diseased tissue.

[0137] According to one embodiment, the central nervous system / central cerebrospinal fluid system suffers from a central nervous system-related disease and needs to be treated by drug administration, and the medical device is configured to:

[0138] -Select diseased tissue as the area to receive fluids and medications,

[0139] - simulate fluid transport towards diseased tissue, and

[0140] - Controlling fluid delivery, applying electrical potentials and / or currents to the electrodes to control fluid delivery and drug delivery to a target area.

[0141] According to one embodiment, a medical device is used to modulate neural plasticity and excitatory / inhibitory polarization during electrical stimulation therapy.

[0142] According to one embodiment, the medical device places at least one anode component to cover the target tissue. Preferably, the medical device controls fluid transport and applies an electric potential and / or current to drive at least one fluid to flow to a natural drainage channel. The fluid can be blood, interstitial fluid, extracellular fluid, intracellular fluid, cerebrospinal fluid or spinal fluid. Preferably, the medical device controls fluid transport in the individual body, and its direction is from the target tissue to the adjacent brain area to achieve the self-circulation of the brain. Preferably, the medical device controls fluid transport in the individual body, and its direction is from the target tissue to the CSF system. According to one embodiment, the central nervous system / cerebrospinal fluid system includes a brain suffering from edema, cerebral hemorrhage, Alzheimer's disease and / or Parkinson's disease, and the medical device controls fluid transport to drive at least one fluid away from the target tissue, toward the adjacent brain area and / or toward the cerebrospinal fluid filling space.

[0143] According to one embodiment, the medical device comprises an electrode system assembly and at least two spaced apart electrodes in electrical communication with the central nervous system / cerebrospinal fluid system to be treated, such as a helmet-like device, the electrodes of which are to be placed at predetermined locations / positions on the electrode system assembly.

[0144] According to one embodiment, a medical device consisting of an electrode system assembly and at least two spaced electrodes is placed on the central nervous system / cerebrospinal fluid system to be treated. In one embodiment, the medical device is placed on a vertebra. In one embodiment, the medical device is placed on an animal. In one embodiment, the medical device is placed on an individual. In one embodiment, the medical device is placed on a human. In one embodiment, the medical device is placed on a patient.

[0145] In one embodiment, in step b), a device comprising at least one anode and at least one cathode is placed at a fixed designated location of the CNS / CSF system to be treated.

[0146] According to one embodiment, an electrode system device is placed on the CNS / CSF system, and the electrode system device is a net, a cap or a helmet, which is configured to be mounted on the head of the person to be treated. In addition, the electrode system device can also be a cap or a helmet, which is shaped to be mounted on the head of the person to be treated. The electrode system device is preferably in the shape of a helmet, which can be mounted on the head of the person to be treated. Alternatively, the electrode system device is in the shape of a cap, which can be put on the head of the person to be treated.

[0147] In one embodiment, the electrode system device may include free electrodes that can be placed on the CNS / CSF system.

[0148] In one embodiment, the free electrodes may be connected to an electrode system assembly.

[0149] In one embodiment, the free electrode can be repositioned to the electrode system device and / or can be detached and reattached to the electrode system device.

[0150] According to one aspect, the present invention includes a medical device for inducing and regulating controlled fluid transport in a central nervous system (CNS) and / or cerebrospinal fluid (CSF) system by electroosmosis, the medical device comprising an electrode system device, at least two electrodes spaced apart on the electrode system device, and electrical wiring, wherein according to step b), the electrode system device and the electrodes are configured to be placed on the CNS / CSF system to establish electrical communication between the electrodes and the CNS / CSF system; and according to step c), the wiring is configured to allow a control unit to control the electrodes.

[0151] According to one of the embodiments, the medical device comprises at least two electrodes arranged at intervals on the electrode system device, at least one of which is used as an anode and at least one of which is used as a cathode. According to one of the embodiments, the medical device comprises at least two electrodes arranged at intervals on the electrode system device, at least one of which is inserted into the ventricular system and at least one of which is placed on the surface of the head. According to one of the embodiments, the medical device comprises at least two electrodes arranged at intervals on the electrode system device, at least one of which is inserted into the ventricular system and at least one of which is placed on the surface of the head. According to one embodiment, the medical device comprises at least two electrodes arranged at intervals on the electrode system device, at least one of which is inserted into the target tissue and at least one of which is placed on the surface of the head. Preferably, the number of anodes and cathodes activated during treatment is determined based on a design method obtained by computer simulation of induced fluid transport in a patient-individualized three-dimensional head model.

[0152] According to one embodiment, the medical device comprises at least two groups of electrodes arranged along the electrode system device, wherein at least one group is used as an anode and at least one group is used as a cathode. According to one embodiment, the medical device comprises at least one group of electrodes arranged in a row along the electrode system device. In one embodiment, the medical device comprises a second group of electrodes arranged along the second row of the electrode system device. Thus, the medical device can apply an electric field to the central nervous system / cerebrospinal fluid system from all directions. This allows for better and more precise control of the induced fluid flow inside the CNS / CSF system. According to one embodiment, the cathode electrode is placed outside the one centimeter area of ​​the sagittal midplane contour of the skull. In one embodiment, at least one electrode is arranged on the surface of the head near the target tissue. The electrode near the target tissue is preferably a cathode and generates a fluid flow to the subarachnoid space next to the target tissue and enters the cerebrospinal fluid circulation. In one embodiment, at least one electrode is arranged on the surface of the head near the target tissue. The electrode near the target tissue is preferably an anode and generates a fluid flow from the target tissue to the surrounding brain tissue / subarachnoid space to the cerebrospinal fluid circulation. In one embodiment, at least one electrode is arranged to be inserted into the target tissue. The electrode inserted into the target tissue is preferably an anode and generates fluid flow to the subarachnoid space and enters the cerebrospinal fluid circulation. In one embodiment, at least one electrode is placed on the dura mater of the person. This may occur if the patient has a defect in the skull. In a preferred treatment method, the device is configured so that when the device is placed on the patient's head, at least some of the electrodes are in electrical communication with the patient's skull. In one embodiment, the medical device is configured so that when the medical device is placed on the person, the electrodes are in electrical communication with the person's skin.

[0153] According to one embodiment, the electrode system device is a mesh, a cap or a helmet that can be mounted on the head of the person to be treated and establish electrical communication between the device electrodes and the central nervous system / central cerebrospinal fluid system at predetermined locations.

[0154] The medical device preferably includes wiring for electrically connecting the electrodes to one or more potential and / or current generators. The wiring may include an electrical grid and electrical contacts that can be connected to one or more potential and / or current generators. According to one embodiment, the configuration of the wiring allows independent control of the potential and / or current applied to at least two groups of electrodes in the medical device. Preferably, at least one group includes one or more electrodes, each of which is configured as a cathode, and at least one group includes one or more electrodes, each of which is configured as an anode. The wiring is preferably configured so that each group of anodes can be individually controlled relative to the other group of anodes. According to one embodiment, the configuration of the medical device allows independent control of the potential and / or current applied to each individual electrode. Preferably, the configuration of the wiring allows each group of electrodes to be individually controlled.

[0155] According to one aspect, the present invention comprises a computer program module, which is configured to control a computer to perform steps a1) to a3).

[0156] According to one aspect, the present invention comprises a computer program module configured to control a computer or system to perform steps a1) to a3), steps a) and c).

[0157] According to one embodiment, the computer program module is configured to control a computer to execute the apparatus described in the claims to perform steps a1) to a3), steps a) and c).

[0158] A computer program module may comprise a subroutine of a computer program, a computer program, a computer or a microcontroller programmed with the computer program, or a computer program product, such as a computer program memory storing the computer program.

[0159] According to one aspect, the present invention comprises a medical device for treating a disease by inducing and regulating controlled fluid delivery, wherein the controlled fluid delivery in the central nervous system (CNS) and / or cerebrospinal fluid (CSF) system is induced and regulated by electroosmosis, comprising:

[0160] - an electrode system device (100, 200) configured to place two or more electrodes (101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 201, 202) in electrical communication with a central nervous system (CNS) and / or a cerebrospinal fluid (CSF) system, each electrode being placed at one of a selected set of electrode locations, wherein a cathode electrode is placed outside a one centimeter region of a mid-sagittal cranial contour;

[0161] - a control unit for controlling the application of electric potentials and / or currents to said electrodes, wherein the selected electric potentials and / or currents are selected as electric potentials and / or currents associated with a selected set of electrode locations by means of electroosmotic information in order to induce and modulate controlled fluid transport in said central nervous system and / or cerebrospinal fluid system, and / or modulate neuroplasticity and excitatory / inhibitory polarization, and

[0162] - A computer program module for receiving electroosmotic information, the electroosmotic information at least indicating a fluid transport response generated by applying a specific potential and / or current at a specific electrode position on the patient's head based on the patient's individualized three-dimensional head model, and receiving a fluid flow path in the patient's head so as to select a set of electrode positions using the electroosmotic information and the fluid flow path; and controlling the control unit to perform step c).

[0163] According to one embodiment, the medical device comprises a computer program module configured to perform steps a1) to a3).

[0164] In order to achieve controlled fluid transport in the central nervous system and / or cerebrospinal fluid system, the electroosmotic information includes electrode position information and / or electrode potential information and / or electrode current information.

[0165] wherein electroosmosis information is received by computer simulation of induced fluid transport in a patient-individualized three-dimensional head model of the central nervous system / cerebrospinal fluid system; wherein the patient-individualized three-dimensional head model is generated based on a set of medical images of the central nervous system / cerebrospinal fluid system; and the simulation is performed by applying an electric potential and / or current to at least one simulated anode electrode and at least one simulated cathode electrode to generate a fluid transport response, wherein the anode electrode and the cathode electrode are in electrical communication with the central nervous system / cerebrospinal fluid system in the patient-individualized three-dimensional head model.

[0166] The computer program module is configured to: select a region of the central nervous system and / or cerebrospinal fluid system from which fluid is to be discharged, and set a target location for receiving fluid as the region of the central nervous system and / or cerebrospinal fluid system from which fluid is to be received.

[0167] Wherein, the electrode system device (100, 200) is configured as follows:

[0168] b1) placing at least one cathode electrode in electrical communication with the central nervous system / cerebrospinal fluid system behind and / or within the receiving fluid region as viewed from the draining fluid region, and

[0169] b2) placing at least one anode electrode in electrical communication with the central nervous system / cerebrospinal fluid system at a spaced position behind and / or within the area from which the fluid is discharged, as viewed from the area receiving the fluid.

[0170] The control unit (300) is configured to independently control the potential and / or current of at least one cathode electrode and at least one anode electrode so as to centrally transport the fluid from the discharge fluid region to the receiving fluid region.

[0171] The medical image set is a set of computed tomography images and / or a set of multimodal medical images, and the multimodal medical images include magnetic resonance imaging images and / or ultrasound images and / or positron emission tomography images.

[0172] The computer program modules include:

[0173] a1) a computer memory for receiving at least one set of medical images of the central nervous system / cerebrospinal fluid system;

[0174] a2) a computer program configured to generate a patient-specific three-dimensional head model of the central nervous system / cerebrospinal fluid system based on the received medical images, and

[0175] a3) a computer configured to stimulate fluid transport in the patient's individualized three-dimensional head model in response to an electric potential and / or current applied through at least one simulated anode electrode and at least one simulated cathode electrode, which are placed at selected locations and are in electrical communication with the central nervous system and / or cerebrospinal fluid system to generate electroosmotic information.

[0176] The selected set of electrode positions includes a position of at least one anode electrode that is located behind or inside the discharge fluid region as viewed from the receiving fluid region.

[0177] The selected set of electrode positions includes at least one cathode electrode, which is located behind or inside the fluid receiving area as seen from the fluid discharge area.

[0178] Wherein, the central nervous system and / or cerebrospinal fluid system suffers from cerebral edema and / or hematoma, and the medical device is configured to:

[0179] - selecting the fluid source location as an area containing edema and / or hematoma and using it as the drain fluid area;

[0180] - simulating the fluid transport process from edema and / or hematoma to the subarachnoid space using the patient-specific 3D head model, and

[0181] -Controlling fluid delivery, applying an electrical potential and / or current to the electrodes to control fluid delivery away from edema and / or hematoma.

[0182] Wherein, the central nervous system and / or cerebrospinal fluid system suffers from cerebral edema, and the medical device is configured to:

[0183] - selecting the fluid source location as an area containing edema and using it as the drain fluid area;

[0184] - using the patient-specific three-dimensional head model to simulate the transport of fluid in a direction away from the edema towards adjacent healthy brain tissue, and

[0185] - controlling fluid delivery, applying an electrical potential and / or current to the electrodes to control fluid delivery from the edema to adjacent brain tissue;

[0186] -Excess fluid from adjacent brain tissue is drawn into the intravascular space by hyperosmotic therapy.

[0187] Wherein, the central nervous system / cerebrospinal fluid system suffers from cerebral hemorrhage, Alzheimer's disease and / or Parkinson's disease, and the medical device is configured as follows:

[0188] -Select target tissue as an area containing brain waste and / or blood clots to drain fluid;

[0189] - simulating the fluid transport process from the target tissue to the cerebrospinal fluid-filled space using the patient-specific three-dimensional head model, and

[0190] - Controlling fluid delivery, applying an electrical potential and / or current to the electrodes to control fluid delivery, including delivery of brain waste and / or blood clots from target tissue to cerebrospinal fluid-filled spaces; wherein the cerebrospinal fluid-filled spaces are the ventricular system and the subarachnoid space.

[0191] Wherein, the central nervous system / cerebrospinal fluid system suffers from intracerebral hemorrhage, Alzheimer's disease and / or Parkinson's disease and has received medication, and the medical device is configured as:

[0192] -Select target tissue as the area containing brain waste to drain fluid;

[0193] - Drug treatment breaks down large harmful proteins and / or blood clots in target tissues into powder or small particles;

[0194] - using the patient-specific three-dimensional head model to simulate the transfer of fluid from target tissue to the cerebrospinal fluid-filled space;

[0195] - Controlling fluid transport, applying an electrical potential and / or current to the electrodes to control fluid transport of brain waste from target tissue to cerebrospinal fluid-filled spaces; wherein the cerebrospinal fluid-filled spaces are the ventricular system and the subarachnoid space; wherein the brain waste is a powder or small particles.

[0196] Wherein, the central nervous system / cerebrospinal fluid system suffers from Alzheimer's disease and / or Parkinson's disease and has received deep brain stimulation therapy, and the medical device is configured as follows:

[0197] -Select target tissue as the area containing brain waste to drain fluid;

[0198] -Set the deep brain stimulation electrode as the anode and the selected medical device electrode as the cathode;

[0199] - simulating the fluid transport process from the target tissue to the cerebrospinal fluid-filled space using the patient-specific three-dimensional head model, and

[0200] - Controlling fluid transport and applying an electrical potential and / or current to the electrodes to control fluid transport, including the transport of brain waste products from target tissue to the cerebrospinal fluid-filled space.

[0201] Among them, the CNS / CSF system suffers from CNS-related diseases and requires drug treatment through the BBB. The medical device is configured as:

[0202] -Selection of diseased tissue as the area to receive the drug;

[0203] - placing the anode close to the target tissue and the cathode away from the target tissue, and

[0204] -Control fluid transport and apply electric potential and / or current to electrodes to promote drug delivery across the BBB to diseased tissue.

[0205] Wherein the central nervous system / cerebrospinal fluid system is afflicted with edema and / or hematoma and has been treated with deep brain stimulation, the medical device is configured to:

[0206] - selecting the fluid source location as an area containing edema and / or hematoma and using it as the drain fluid area;

[0207] -Set the deep brain stimulation electrode as the anode and the selected medical device electrode as the cathode;

[0208] - simulating the fluid transport process from the target tissue to the cerebrospinal fluid-filled space using the patient-specific three-dimensional head model, and

[0209] -Controlling fluid delivery and applying an electrical potential and / or current to the electrodes to control fluid delivery away from edema and / or hematoma.

[0210] Wherein, the central nervous system / cerebrospinal fluid system suffers from a disease related to the central nervous system and needs to be treated by drug administration, and the medical device is configured as follows:

[0211] -Select diseased tissue as the area to receive fluids and medications;

[0212] - using the patient-specific three-dimensional head model to simulate the transport of fluid toward the diseased tissue;

[0213] - Controlling fluid transport, applying electrical potentials and / or currents to the electrodes to control fluid transport for delivering drugs to diseased tissue.

[0214] The medical device is configured to control the application of electric potential and / or current to the electrodes to regulate neural plasticity and excitatory / inhibitory polarization of diseased tissue.

[0215] Wherein the central nervous system / cerebrospinal fluid system includes a brain suffering from cerebral edema, intracerebral hemorrhage, Alzheimer's disease, and / or Parkinson's disease, and the medical device includes controlling fluid transfer so as to drive at least one fluid from the diseased area to adjacent brain tissue and / or cerebrospinal fluid-filled space.

[0216] The medical device comprises at least two electrodes, and at most 100 electrodes, which are arranged at intervals on the electrode system device, wherein each electrode can be set as an anode or a cathode according to the design method.

[0217] The current used for treatment is direct current or alternating current with an average amplitude between 0.1 and 200 mA, thereby producing continuous stimulation, intermittent stimulation or hammer-type stimulation.

[0218] The patient-individualized three-dimensional head model includes a three-dimensional model of the central nervous system / cerebrospinal fluid system consisting of the brain and / or cerebrospinal fluid and / or scalp and / or ventricle and / or skull.

[0219] The medical device includes an electrode system device (100, 200) with at least two spaced electrodes (101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 201, 202) placed to electrically communicate with the central nervous system / cerebrospinal fluid system to be treated.

[0220] The electrode system device (100, 200) is a mesh-shaped, cap-shaped or helmet-shaped device that can be installed on the head of a person to be treated.

[0221] According to one embodiment, the medical device comprises a control unit comprising one or more potential and / or current generators configured to provide potentials and / or currents to electrodes of the device.

[0222] The invention is not limited to the detailed description, examples and drawings, but may be varied freely within the framework of the following claims. In particular, the features disclosed herein in relation to the method according to the invention performed by a device may be freely adapted, as the case may be, for use in a device, system or computer program model, and vice versa.

[0223] Fig.13 A flow chart of a method performed by a device 100, 200 according to one or more embodiments of the present disclosure is shown. The device induces and regulates controlled fluid transport in a patient's central nervous system and / or cerebrospinal fluid system by electroosmosis through two or more electrodes placed at selected locations on the patient's head and / or brain, and the device is configured to:

[0224] Step 131: Receive electroosmotic information, the electroosmotic information at least indicating a fluid transport response generated by applying a specific potential and / or current at a specific electrode position on the patient's head according to the patient's individualized three-dimensional head model.

[0225] In one embodiment, the electroosmotic information includes information about electrode position and / or electrode potential and / or electrode current, which is selected to achieve controlled fluid transfer or fluid transfer response in said central nervous system / cerebrospinal fluid system.

[0226] In one embodiment, the electroosmotic information is received by generating the electroosmotic information through computer simulation of induced fluid transport in a patient-specific three-dimensional head model of the central nervous system / cerebrospinal fluid system.

[0227] The patient-specific three-dimensional head model is usually generated based on a set of medical images of the central nervous system / cerebrospinal fluid system. The simulation is usually performed by electrically communicating with the central nervous system / cerebrospinal fluid system of the patient-specific three-dimensional head model through at least one simulated anode electrode and at least one simulated cathode electrode, simulating the fluid transport response after applying an electric potential and / or current.

[0228] In other words, simulations are performed using a patient-specific 3D head model, assuming electrode placement at a selected set of electrode locations, and applying specific potentials and / or currents associated with specific electrode locations on the patient's head. After evaluating the patient-specific 3D head model using the specific potentials and / or currents, a fluid transport response is obtained. This typically indicates fluid flow from a fluid source location to a fluid target location, such as from a lesion to a space filled with cerebrospinal fluid.

[0229] In one embodiment, the electroosmotic information is received by retrieving predetermined electroosmotic information from a memory, such as from an established database / lookup table and / or historical simulation.

[0230] In one embodiment, electroosmotic information is received by receiving user input from an input device, for example, a clinician inputs selected electrode and / or potential and / or current positions based on past patient treatment experience.

[0231] Step 132: Receive the position of the target tissue in the patient's head. The position can be obtained from a set of medical images of the central nervous system / cerebrospinal fluid system, or input by the user through an input device.

[0232] Step 133: Select a set of electrode positions using the electroosmotic information and the target tissue position. The electrode positions can be selected based on a set of electrode positions given by the electroosmotic information to provide a desired or optimal fluid transport response.

[0233] In one embodiment, the step of selecting a set of electrode locations further comprises designating each location as a cathode or an anode location and applying a specific potential and / or current therein.

[0234] Step 134: Placing two or more electrodes in electrical communication with the central nervous system / cerebrospinal fluid system, each electrode being positioned at a location in the selected set of electrode locations.

[0235] In other words, at a selected set of electrode locations, two or more electrodes are connected to the head surface and / or inserted into the brain. If the electrode system device provides a plurality of electrodes with predetermined electrode locations, a set or sub-set of the plurality of electrodes may be activated, such as Figure 3-11 shown.

[0236] Step 135: Controlling the application of a selected potential and / or current to the electrodes, wherein the selected potential and / or current is a potential and / or current associated with a selected set of electrode positions selected by electroosmotic information. In this way, controlled fluid transport can be introduced into the central nervous system / cerebrospinal fluid system, and / or neuroplasticity and excitatory / inhibitory polarization can be regulated.

[0237] In one embodiment, the medical device selects a region of the CNS / CSF system from which fluid is to be drained and receives the fluid target location as the location of the selected region of the CNS / CSF system from which the fluid is to be received. In addition, the step of placing electrodes includes b1) placing at least one cathode electrode in electrical communication with the CNS / CSF system at a position behind and / or inside the region from which the fluid is to be received, e.g., as viewed from the region from which the fluid is to be drained; and b2) placing at least one anode electrode in electrical communication with the CNS / CSF system at a position behind and / or inside the region from which the fluid is to be drained, e.g., as viewed from the region from which the fluid is to be received (e.g., the superior sagittal sinus).

[0238] In one embodiment, step 135 further includes c1), for example, by a control unit, controlling the application of an electric potential and / or current to at least one cathode electrode and at least one anode electrode so as to concentrate fluid transport from a selected fluid discharge area to a selected fluid receiving area.

[0239] In one example, fluid delivery is focused from a region to a fluid target location.

[0240] In one embodiment, the medical image set is a set of computed tomography (CT) images and / or a set of multimodal medical images, such as magnetic resonance imaging (MRI) images and / or ultrasound images and / or positron emission tomography (PET) images. It goes without saying that other suitable or available methods may be used to obtain image scans without departing from the present disclosure.

[0241] In one embodiment, the patient-individualized three-dimensional head model of the central nervous system / cerebrospinal fluid system is generated using a medical image set. In this embodiment, the medical device is configured to a1) receive at least one set of medical images of the CNS / CSF system in a computer memory; a2) generate a patient-individualized three-dimensional head model of the CNS / CSF system based on the received medical image set, such as by a smoothed voxel method; and a3) simulate the patient-individualized three-dimensional head model of the CNS / CSF system, using a computer to simulate fluid transport in the patient-individualized three-dimensional head model in response to an electric potential and / or current applied through at least one simulated anode electrode and at least one simulated cathode electrode, which are placed at selected locations and in electrical communication with the CNS / CSF system to generate electroosmotic information.

[0242] In one embodiment, a patient-individualized 3D head model is constructed based on the patient's medical images using a smoothed voxel approach. First, the patient's medical images are segmented into voxels representing the CSN / CSF system using the expectation maximization (EM) algorithm (Dempster et al., 1977). The voxels are then converted into meshes using various smoothing algorithms (such as the algorithm developed by Boyd and Müller (2006)), and material properties are assigned to different parts of the CSN / CSF system to form a patient-individualized 3D finite element head model. In one example, a patient-individualized 3D head model is generated using a baseline head model and the patient's medical images using various mesh deformation algorithms (such as image registration-based deformation), and then the mesh is grouped based on the patient's images to account for the patient's damaged neural tissue (Li et al., 2021).

[0243] References include: Dempster AP, Laird NM, Rubin DB, "Maximum likelihood from incomplete data via the EM algorithm", Journal of the Royal Statistical Society: Series B (Methodological).1977Sep; 39(1):1-22, Boyd SK, Müller R. "Smoothsurface meshing for automated finite element model generation from 3D imagedata", Journal of Biomechanics.2006Jan 1;39(7):1287-95, and Li

[0244] In one embodiment, the central nervous system / cerebrospinal fluid system suffers from cerebral edema, and the medical device is configured to select a fluid source location as a target area that includes edema and requires fluid drainage, simulate fluid transport away from the edema using the patient-individualized three-dimensional head model, and control fluid transport and apply an electric potential and / or current to the electrode to control fluid transport away from the edema.

[0245] In one embodiment, the central nervous system / central cerebrospinal fluid system has a hematoma, and the medical device is configured to select a fluid source location as an area including the hematoma with the goal of draining the fluid; simulate fluid transport away from the hematoma using the patient's individualized three-dimensional head model; and control the fluid transport and apply an electric potential and / or current to the electrode to control the fluid transport away from the hematoma.

[0246] In one embodiment, the central nervous system / cerebrospinal fluid system suffers from cerebral hemorrhage, Alzheimer's disease and / or Parkinson's disease, and the medical device is configured to select local brain tissue or the entire brain tissue as a target area, which target area contains brain waste products, such as blood clots, amyloid beta protein, tau protein and / or metal ions, and is a target area to be drained of fluid, simulate the transport of fluid in a direction away from the target area using a patient-individualized three-dimensional head model, and control the fluid transport and apply an electric potential and / or current to the electrodes to control the fluid transport and brain waste products away from the target area.

[0247] In one embodiment, the central nervous system / cerebrospinal fluid system includes a lymphoid fluid flow, the medical device is configured to select a fluid source location as an area including lymphoid fluid, target an area to drain the fluid or target an area to regulate the fluid, simulate regulation / modification of the lymphoid fluid flow using the patient-individualized three-dimensional head model, and control fluid delivery and apply an electrical potential and / or current to the electrode to control regulation of the lymphoid fluid flow.

[0248] In one embodiment, the central nervous system / central cerebrospinal fluid system includes a brain having cerebral edema or hematoma, and the medical device is configured to control fluid transport to drive at least one fluid away from the edema, toward adjacent brain tissue or the ventricular system, and / or to the subarachnoid space.

[0249] In one embodiment, the central nervous system / central cerebrospinal fluid system includes a brain suffering from cerebral hemorrhage, Alzheimer's disease and / or Parkinson's disease, and the medical device is configured to control fluid transport so as to expel at least one fluid along with brain waste from the target tissue to the ventricular system and / or the subarachnoid space.

[0250] In one embodiment, the CNS / CSF system includes a brain suffering from a CNS-related disease requiring drug treatment across the BBB, and the medical device is configured to control fluid transport to facilitate drug delivery across the BBB to the diseased tissue.

[0251] In one embodiment, the patient-specific three-dimensional head model includes a three-dimensional model of the central nervous system / cerebrospinal fluid system.

[0252] In one embodiment, the patient-specific three-dimensional head model includes information about the fiber structure within the central nervous system / cerebrospinal fluid system.

[0253] In one embodiment, the patient-specific three-dimensional head model includes information of damaged neural tissue and healthy neural tissue.

[0254] In one embodiment, the patient-individualized three-dimensional head model includes a three-dimensional model of the brain and / or cerebrospinal fluid and / or scalp and / or cerebral ventricles and / or skull.

[0255] In one embodiment, the medical device is configured to place an electrode system device, such as an electrode system device including a mechanically connected body and at least two spaced electrodes in electrical communication with the CNS / CSF system to be treated. When the patient wears the electrode system device, the electrodes are usually electrically connected to the central nervous system / cerebrospinal fluid system. The electrode system device can be a mesh, a cap, or a helmet, configured to be mounted on the head of the person to be treated, so as to place electrodes in electrical communication with the CNS / CSF system to be treated at a predetermined position / location on the patient's head.

[0256] In one embodiment, the medical device further comprises a control unit for inputting an electric potential and / or current to the electrode, and a control circuit coupled to the electrode. The control unit 300 may be in the form of an electronic control unit, a server, an onboard computer, a fixed computing device, a laptop, a tablet computer, a handheld computer, a wrist-worn computer, a smart watch, a smart phone, or a smart TV. The control unit 300 may include a processing circuit that communicates with a transceiver, and the transceiver is configured for wired or wireless communication. The control unit 300 may also include at least one optional antenna. The antenna may be coupled to the transceiver and configured to transmit and / or transmit and / or receive wired or wireless signals in a communication network such as WiFi, Bluetooth, 3G, 4G, 5G, etc. In one or more embodiments, the control unit 300 may further include an input device configured to receive input or instructions from a user and send a user input signal indicating the user input or indication to the processing circuit. In one or more embodiments, the control unit 300 may further include a display configured to receive a display signal indicating a rendered object (e.g., a text or graphical user input object) from the processing circuit, and display the received signal as an object (e.g., a text or graphical user input object). In another embodiment, the control unit 300 may further include and / or be connected to one or more additional sensors configured to receive and / or acquire and / or measure physical characteristics related to the location and / or patient and / or device, such as a temperature sensor to measure the ambient air temperature.

[0257] In addition, the skilled person also realizes that the control unit 300 may include necessary communication functions, such as functions, means, units, elements, etc. for executing the solution of the present embodiment. Examples of other such means, units, elements and functions include processors, memories, buffers, control logic, encoders, decoders, rate matchers, de-rate matchers, mapping units, multipliers, decision units, selection units, switches, interleavers, de-interleavers, modulators, demodulators, inputs, outputs, antennas, amplifiers, receiving units, transmitting units, DSPs, MSDs, TCM encoders, TCM decoders, power supply units, feeding devices, communication interfaces, communication protocols, etc. These devices are appropriately arranged together to execute the solution of the present embodiment.

[0258] In particular, the processing circuits and / or processing means of the present disclosure may include one or more processing circuits, processor modules, and multiple processors, central processing units (CPUs), processing units, processing circuits, processors, application specific integrated circuits (ASICs), microprocessors, field programmable gate arrays (FPGAs), or other processing logic that can interpret and execute instructions configured to cooperate with each other. Therefore, the expression "processing circuit" and / or "processing device" may represent a processing circuit composed of multiple processing circuits, such as any, some or all of the above-mentioned processing circuits. The processing device may further perform data processing functions for inputting, outputting and processing data, including data buffering and device control functions, such as user interface control or similar functions.

[0259] List of implementation plans

[0260] Embodiment 1. A medical device for treating a disease by inducing and regulating controlled fluid delivery, for inducing and regulating controlled fluid delivery in a central nervous system (CNS) and / or cerebrospinal fluid (CSF) system by electroosmosis, configured to:

[0261] a) receiving information about electrode positions and / or about electrode potentials and / or electrode currents to achieve controlled fluid transport in the CNS / CSF system, wherein the information is generated by a computer simulation of induced fluid transport in a computer model of the CNS / CSF system, the computer model being generated based on a set of medical images of the CNS / CSF system, the simulation being performed by simulating a fluid transport response resulting from application of an electrical potential and / or current to at least one simulated anode and at least one simulated cathode in electrical communication with the CNS / CSF system in the computer model;

[0262] b) placing at least two electrodes in electrical communication with said central nervous system / cerebrospinal fluid system, wherein the cathode electrode is placed one centimeter outside the sagittal mid-surface outline of the skull, and

[0263] c) Based on the information received from the computer simulation, controlling the application of electric potential and / or current to the electrodes by a control unit to induce and modulate controlled fluid transport in the central nervous system / cerebrospinal fluid system, and / or modulate neural plasticity and excitatory / inhibitory polarization.

[0264] Embodiment 2. A medical device for treating a disease by inducing and regulating controllable fluid delivery, which is configured to: select an area in the CNS / CSF system that needs to drain fluid, and select an area in the CNS / CSF system that needs to receive fluid, step b) comprising:

[0265] b1) placing at least one cathode in electrical communication with the CNS / CSF system behind and / or within the area to receive the fluid, as viewed from the area to be drained, and

[0266] b2) placing at least one anode in electrical communication with the CNS / CSF system at a spaced location behind and / or within the area to be drained of fluid, as viewed from the area to be received of fluid.

[0267] Embodiment 3. Step c) comprises:

[0268] c1) applying an electric potential and / or current to at least one cathode and at least one anode by controlling the control unit so as to centrally transport the fluid from the selected fluid discharge area to the selected fluid receiving area;

[0269] c2) using a control unit to control the application of electric potential and / or current to at least one cathode and at least one anode to regulate neural plasticity and excitatory / inhibitory polarization.

[0270] Embodiment 4. The medical image set is a group of CT images, PET images, DTI images, ultrasound images and / or magnetic resonance images.

[0271] Embodiment 5. A medical device for treating a disease by inducing and regulating controllable fluid delivery, configured to:

[0272] a1) receiving in a computer memory at least one set of medical images of the central nervous system / cerebrospinal fluid system,

[0273] a2) generating a computer model of the CNS / CSF system based on the received medical image set, and

[0274] a3) simulating, using a computer, fluid transport in the computer model of the CNS / CSF system in response to an electrical potential and / or current applied through at least one simulated anode and at least one simulated cathode in electrical communication with the CNS / CSF system.

[0275] Embodiment 6. A medical device for treating a disease by inducing and regulating controlled delivery of fluid, wherein the CNS / CSF system suffers from cerebral edema, the medical device being configured to:

[0276] - Select the edematous area as the area that needs to be drained,

[0277] - simulated fluid flow away from edema, and

[0278] - Controlling fluid delivery and applying an electrical potential and / or current to the electrodes to control fluid delivery from the edema to spaces filled with cerebrospinal fluid, such as the ventricular system and the subarachnoid space, into the cerebrospinal circulation.

[0279] Embodiment 7. A medical device for treating a disease by inducing and regulating controlled delivery of fluid, wherein the CNS / CSF system suffers from cerebral edema, the medical device being configured to:

[0280] -Select the edematous area as the area that needs to be drained,

[0281] - simulated fluid flow away from edema, and

[0282] - controlling fluid delivery and applying an electrical potential and / or current to the electrodes to control fluid delivery from the edema to adjacent brain tissue,

[0283] -Excess fluid from adjacent brain tissue is drawn into the intravascular space by hyperosmotic therapy.

[0284] Embodiment 8. A medical device for treating a disease by inducing and regulating controlled delivery of fluid, wherein the central nervous system / cerebrospinal fluid system is afflicted with hematoma, the medical device being configured to:

[0285] -Select the hematoma area for drainage,

[0286] - simulated fluid flow away from edema, and

[0287] -Controlling fluid delivery and applying an electrical potential and / or current to the electrodes to control fluid delivery from the hematoma to cerebrospinal fluid-filled spaces, such as the ventricular system and subarachnoid space, into the cerebrospinal fluid circulation.

[0288] Embodiment 9. A medical device for treating a disease by inducing and regulating controllable delivery of a fluid, wherein the central nervous system / cerebrospinal fluid system suffers from cerebral hemorrhage, Alzheimer's disease and / or Parkinson's disease, the medical device being configured as follows:

[0289] -selecting a target tissue as the area for draining fluid,

[0290] - simulate the transport of fluid away from the target tissue, and

[0291] - Controlling fluid delivery, applying an electrical potential and / or current to the electrodes to control fluid delivery and transfer of brain waste and / or blood clots from target tissue to the cerebrospinal fluid filled space.

[0292] Embodiment 10. A medical device for treating a disease by inducing and regulating controllable delivery of a fluid, wherein the central nervous system / cerebrospinal fluid system suffers from cerebral hemorrhage, Alzheimer's disease and / or Parkinson's disease and has received drug treatment, and the medical device is configured as follows:

[0293] -selecting a target tissue as the area for draining fluid,

[0294] -Break down large harmful proteins and / or blood clots in target tissues into powder or small particles through drug treatment,

[0295] - simulate the transport of fluid away from the target tissue, and

[0296] - Controlling fluid transport and applying electrical potentials and / or currents to the electrodes to control fluid transport and the transfer of brain waste products (such as powders or small particles) from target tissues to cerebrospinal fluid-filled spaces.

[0297] Embodiment 11. A medical device for treating a disease by inducing and regulating controllable fluid delivery, wherein the central nervous system / cerebrospinal fluid system suffers from Alzheimer's disease and / or Parkinson's disease and has received DBS treatment, and the medical device is configured as follows:

[0298] -selecting a target tissue as the area for draining fluid,

[0299] - Select the DBS electrode as the anode and the electrode of the medical device as the cathode,

[0300] - simulate the transport of fluid away from the target tissue, and

[0301] - Controlling fluid transport and applying electrical potentials and / or currents to the electrodes to control fluid transport and the flow of brain waste products from target tissue to the cerebrospinal fluid-filled space.

[0302] Embodiment 12. A medical device for treating a disease by inducing and regulating controlled fluid delivery, wherein the central nervous system / cerebrospinal fluid system is suffering from edema and / or hematoma and has been treated with DBS, the medical device being configured to:

[0303] -selecting a target tissue as the area for draining fluid,

[0304] - Select the DBS electrode as the anode and the electrode of the medical device as the cathode,

[0305] - simulate the transport of fluid away from the target tissue, and

[0306] - Controlling fluid delivery and applying an electrical potential and / or current to the electrodes to control fluid delivery from the target tissue to the cerebrospinal fluid-filled space.

[0307] Embodiment 13. A medical device for treating a disease by inducing and regulating controllable fluid delivery, wherein the central nervous system / cerebrospinal fluid system suffers from a central nervous system-related disease and requires drug treatment through the BBB, the medical device being configured as:

[0308] -Select the diseased tissue as the area to receive the drug,

[0309] - placing the anode close to the target tissue and the cathode away from the target tissue, and

[0310] -Controlling fluid transport and applying electric potential and / or current to the electrodes to promote drug delivery through the BBB to the diseased tissue.

[0311] Embodiment 14. A medical device for treating a disease by inducing and regulating controlled delivery of fluid, wherein the CNS / CSF system suffers from a CNS-related disease that requires treatment by administration, the medical device being configured to:

[0312] -Select diseased tissue as the area to receive fluids and medications,

[0313] - simulate fluid transport towards diseased tissue, and

[0314] - Controlling fluid delivery, applying electrical potentials and / or currents to the electrodes to control fluid delivery and drug delivery to a target area.

[0315] Embodiment 15. A medical device for treating disease by inducing and regulating controllable fluid delivery, wherein electrical stimulation therapy is related to fluid delivery and regulation of neural plasticity and excitatory / inhibitory polarization.

[0316] Embodiment 16. A medical device for treating a disease by inducing and regulating controllable fluid delivery, wherein the central nervous system / cerebrospinal fluid system includes a brain suffering from a central nervous system-related disease, and the device is used to control fluid transport to drive at least one fluid away from a target tissue and flow toward adjacent brain parenchyma and / or toward a space filled with cerebrospinal fluid.

[0317] Embodiment 17. A medical device for treating a disease by inducing and regulating controllable fluid delivery, wherein the computer model comprises a three-dimensional model of the central nervous system / cerebrospinal fluid system.

[0318] Embodiment 18. A medical device for treating a disease by inducing and regulating controllable fluid delivery, wherein the computer model of the central nervous system / central cerebrospinal fluid system includes information on the fiber structure within the central nervous system / cerebrospinal fluid system.

[0319] Embodiment 19. A medical device for treating a disease by inducing and regulating controllable fluid delivery, wherein the computer model includes information of damaged neural tissue and healthy neural tissue.

[0320] Embodiment 20. A medical device for treating a disease by inducing and regulating controllable fluid delivery, wherein the computer model includes a three-dimensional model of the brain, cerebral fluid, ventricles, skull, and scalp.

[0321] Embodiment 21. A medical device for treating a disease by inducing and regulating controllable fluid delivery, the device comprising an electrode system assembly and at least two spaced electrodes that are in electrical communication with the central nervous system / cerebrospinal fluid system to be treated.

[0322] Embodiment 22. A medical device for treating a disease by inducing and regulating controllable fluid delivery, wherein the electrode system device is a mesh, a cap or a helmet that can be mounted on the head of a person to be treated.

[0323] Embodiment 23. A device for inducing and regulating controlled fluid transport in a central nervous system (CNS) and / or cerebrospinal fluid (CSF) system by electroosmosis, the device comprising an electrode system device, at least two electrodes spaced apart on the electrode system device, and wires; wherein the electrode system device is configured to place two or more electrodes (101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 201, 202) for electrical communication with the CNS and / or CSF system, each electrode being placed at one position in a selected group of electrode positions, wherein The cathode electrode is placed outside an area one centimeter away from the sagittal mid-plane contour of the skull; the electrode system device and the electrode are configured to be placed on the CNS / CSF system to establish electrical communication between the electrode and the CNS / CSF system; a control unit (300) is configured to control the application of selected potentials and / or currents to the electrodes, wherein the selected potentials and / or currents are selected as potentials and / or currents associated with a selected set of electrode positions through electroosmotic information to induce and regulate controlled fluid transport in the central nervous system and / or cerebrospinal fluid system, and / or regulate neural plasticity and excitatory / inhibitory polarization; and the wiring is configured to allow the control unit to control the electrodes.

[0324] Embodiment 24. A medical device according to embodiment 23, comprising at least two electrodes and at most 100 electrodes, which are arranged at intervals on the electrode system device, wherein each electrode can be set as an anode or a cathode according to the design.

[0325] Embodiment 25. A medical device according to embodiment 23, comprising at least two electrodes spaced apart on the electrode system device, wherein the electrodes are either placed on the surface of the head or inserted into the central nervous system / cerebrospinal fluid system (such as the ventricular system and brain parenchyma).

[0326] Embodiment 26. According to the medical device described in any of the preceding embodiments, the electrode system device is a net, a cap or a helmet, configured to be mounted on the head of the patient and establish electrical communication between the electrodes of the device and the CNS / CSF system of the patient.

[0327] Embodiment 27. A medical device according to any of the preceding embodiments, wherein the wiring is configured to independently control the potential and / or current applied to at least two sets of electrodes in the device.

[0328] Embodiment 28. A medical device according to any of the preceding embodiments, wherein the configuration of the medical device allows independent control of the potential and / or current applied to each individual electrode.

[0329] Embodiment 29. The medical device according to any of the preceding embodiments, wherein the current used for treatment is direct current or alternating current.

[0330] Embodiment 30. In the medical device provided according to any of the preceding embodiments, the stimulation mode may be continuous stimulation, intermittent stimulation or hammer stimulation.

[0331] Embodiment 31. A computer program module configured to induce a computer to execute: receiving EO information, the EO information at least indicating a fluid transfer response generated by applying a specific potential, electric potential and / or current at a specific electrode position on the patient's head based on the patient's individualized three-dimensional head model, and receiving a fluid flow path within the patient's head so as to select a set of electrode positions using the EO information and the fluid flow path.

[0332] Embodiment 32. A computer program module according to any of the preceding embodiments, the computer program module being configured to induce a computer to execute:

[0333] a1) a computer memory for receiving at least one set of medical images of the central nervous system / cerebrospinal fluid system;

[0334] a2) a computer program configured to generate a patient-specific three-dimensional head model of the central nervous system / cerebrospinal fluid system based on the received medical images, and

[0335] a3) a computer configured to stimulate fluid transport in the patient's individualized three-dimensional head model in response to an electric potential and / or current applied through at least one simulated anode electrode and at least one simulated cathode electrode, which are placed at selected locations and are in electrical communication with the central nervous system and / or cerebrospinal fluid system to generate electroosmotic information.

[0336] Embodiment 33. A computer program module, the computer program being configured to induce a computer to execute:

[0337] receiving electroosmotic information indicating at least a fluid transport response resulting from applying a specific potential and / or current at a specific electrode position on the patient's head based on the patient's individualized three-dimensional head model, and receiving a fluid flow path within the patient's head so as to select a set of electrode positions using the electroosmotic information and the fluid flow path;

[0338] a1) a computer memory for receiving at least one set of medical images of the central nervous system / cerebrospinal fluid system;

[0339] a2) a computer program configured to generate a patient-specific three-dimensional head model of the central nervous system / cerebrospinal fluid system based on the received medical images, and

[0340] a3) a computer configured to stimulate fluid transport in the patient's individualized three-dimensional head model in response to an electric potential and / or current applied through at least one simulated anode electrode and at least one simulated cathode electrode, which are placed at selected locations and are in electrical communication with the central nervous system and / or cerebrospinal fluid system to generate electroosmotic information.

Claims

1. A medical device for treating diseases by inducing and regulating the controllable delivery of liquids, characterized in that: Inducing and modulating controlled fluid transport in the patient's central nervous system and / or cerebrospinal fluid system by electroosmotic flow using two or more electrodes (101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 201, 202) placed at selected locations on the surface of the head or inserted into the brain, including: a) a computer program module configured to receive electroosmotic information, the electroosmotic information indicating at least a fluid transport response resulting from applying a specific electric potential and / or current at a specific electrode position on the patient's head based on the patient's individualized three-dimensional head model, and receive a fluid flow path within the patient's head, so as to select a set of electrode positions using the electroosmotic information and the fluid flow path; b) an electrode system device (100, 200) configured to place two or more electrodes (101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 201, 202) in electrical communication with said central nervous system and / or cerebrospinal fluid system, each electrode being placed at a position in a selected set of electrode positions, wherein a cathode electrode is placed outside an area one centimeter from a sagittal mid-surface contour of the skull; c) a control unit (300) configured to control the application of selected potentials and / or currents to the electrodes, wherein the selected potentials and / or currents are selected as potentials and / or currents associated with a selected set of electrode positions via electroosmotic information so as to induce and modulate controlled fluid transport in the central nervous system and / or cerebrospinal fluid system, and / or modulate neural plasticity and excitatory / inhibitory polarization.

2. The medical device according to claim 1, characterized in that In order to achieve controlled fluid transport in the central nervous system and / or cerebrospinal fluid system, the electroosmotic information includes electrode position information and / or electrode potential information and / or electrode current information.

3. The medical device according to claim 1 or 2, characterized in that: Receiving electroosmotic information by computer simulation of induced fluid transport in a patient-specific three-dimensional head model of the central nervous system / cerebrospinal fluid system; wherein the patient-specific three-dimensional head model is generated based on a set of medical images of the central nervous system / cerebrospinal fluid system; The simulation is performed by applying an electric potential and / or current to at least one simulated anode electrode and at least one simulated cathode electrode to generate a fluid transport response, wherein the anode electrode and the cathode electrode are in electrical communication with the central nervous system / cerebrospinal fluid system in the patient-individualized three-dimensional head model.

4. The medical device according to any one of claims 1 to 3, characterized in that The computer program module is configured to: select a region of the central nervous system and / or cerebrospinal fluid system from which fluid is to be discharged, and set a target location for receiving fluid as the region of the central nervous system and / or cerebrospinal fluid system from which fluid is to be received; The electrode system device (100, 200) is configured as follows: b1) placing at least one cathode electrode in electrical communication with the central nervous system / cerebrospinal fluid system behind and / or within the receiving fluid region as viewed from the draining fluid region, and b2) placing at least one anode electrode in electrical communication with the central nervous system / cerebrospinal fluid system at a spaced position behind and / or within the area from which the fluid is discharged, as viewed from the area receiving the fluid.

5. The medical device according to any one of the preceding claims, characterized in that The control unit (300) is configured to independently control the potential and / or current of at least one cathode electrode and at least one anode electrode so as to centrally transport the fluid from the discharge fluid region to the receiving fluid region.

6. The medical device according to any one of the preceding claims, characterized in that The medical image set is a set of computed tomography images and / or a set of multimodal medical images, wherein the multimodal medical images include magnetic resonance imaging images and / or ultrasound images and / or positron emission tomography images.

7. The medical device according to any one of the preceding claims, characterized in that The computer program modules include: a1) a computer memory for receiving at least one set of medical images of the central nervous system / cerebrospinal fluid system; a2) a computer program configured to generate a patient-specific three-dimensional head model of the central nervous system / cerebrospinal fluid system based on the received medical images, and a3) a computer configured to stimulate fluid transport in the patient's individualized three-dimensional head model in response to an electric potential and / or current applied through at least one simulated anode electrode and at least one simulated cathode electrode, which are placed at selected locations and are in electrical communication with the central nervous system and / or cerebrospinal fluid system to generate electroosmotic information.

8. The medical device according to claim 7, characterized in that The selected set of electrode locations includes a location for at least one anode electrode that is located behind or within the discharge fluid region as viewed from the receiving fluid region.

9. The medical device according to claim 7, characterized in that The selected set of electrode positions includes at least one cathode electrode position that is located behind or inside the fluid receiving area as viewed from the area where fluid is to be discharged.

10. The medical device according to any one of the preceding claims, characterized in that The central nervous system and / or cerebrospinal fluid system suffers from cerebral edema and / or hematoma, the medical device being configured to: selecting the fluid source location as an area containing edema and / or hematoma and using it as the draining fluid area; using the patient-specific three-dimensional head model to simulate the fluid transport process from edema and / or hematoma to the subarachnoid space, and Controlling fluid delivery, applying an electrical potential and / or current to the electrodes to control fluid delivery away from the edema and / or hematoma.

11. The medical device according to any one of the preceding claims, characterized in that The central nervous system and / or cerebrospinal fluid system suffers from cerebral edema, the medical device being configured to: selecting the fluid source location as an area containing edema and using it as the draining fluid area; using the patient-specific three-dimensional head model to simulate fluid transport in a direction away from edema toward adjacent healthy brain tissue, and controlling fluid delivery by applying an electrical potential and / or current to the electrodes to control fluid delivery from the edema to adjacent brain tissue; Hyperosmotic therapy is used to draw excess fluid from adjacent brain tissue into the intravascular space.

12. The medical device according to any one of the preceding claims, characterized in that The central nervous system / cerebrospinal fluid system suffers from cerebral hemorrhage, Alzheimer's disease and / or Parkinson's disease, and the medical device is configured to: Select target tissue as an area containing brain waste and / or blood clots to drain fluid; simulating the fluid transport process from the target tissue to the cerebrospinal fluid-filled space using the patient-specific three-dimensional head model, and Controlling fluid delivery, applying an electrical potential and / or current to the electrodes to control fluid delivery, including delivery of brain waste and / or blood clots from target tissue to cerebrospinal fluid-filled spaces; wherein the cerebrospinal fluid-filled spaces are the ventricular system and the subarachnoid space.

13. The medical device according to any one of the preceding claims, characterized in that The CNS / CSF system suffers from cerebral hemorrhage, Alzheimer's disease and / or Parkinson's disease and has been treated with medication, and the medical device is configured to: Target tissues are selected as areas containing brain waste products to drain fluid; Drug treatment breaks down large harmful proteins and / or blood clots in target tissues into powder or small particles; simulating the transfer of fluid from target tissue to cerebrospinal fluid-filled spaces using the patient-specific three-dimensional head model; Controlling fluid transport, applying an electric potential and / or current to the electrodes to control fluid transport of brain waste from target tissue to cerebrospinal fluid-filled spaces; wherein the cerebrospinal fluid-filled spaces are the ventricular system and the subarachnoid space; wherein the brain waste is a powder or small particles.

14. The medical device according to any one of the preceding claims, characterized in that The patient has Alzheimer's disease and / or Parkinson's disease and has been treated with deep brain stimulation, the medical device is configured to: Target tissues are selected as areas containing brain waste products to drain fluid; The deep brain stimulation electrode is set as the anode and the selected medical device electrode is set as the cathode; simulating the fluid transport process from the target tissue to the cerebrospinal fluid-filled space using the patient-specific three-dimensional head model, and Controlling fluid transport, applying an electrical potential and / or current to the electrodes to control fluid transport, including the transport of brain waste products from the target tissue to the cerebrospinal fluid-filled space.

15. The medical device according to any one of the preceding claims, characterized in that CNS / CSF System Patients with CNS related diseases needing medication to be delivered through the BBB. This medical device is configured to: Select the diseased tissue as the area to receive the drug; Place the anode close to the target tissue and the cathode away from the target tissue, and Fluid transport is controlled and electrical potential and / or current is applied to the electrodes to facilitate drug delivery across the BBB to the diseased tissue.

16. The medical device according to any one of the preceding claims, characterized in that The central nervous system / cerebrospinal fluid system is afflicted with edema and / or hematoma and has been treated with deep brain stimulation, the medical device being configured to: selecting the fluid source location as an area containing edema and / or hematoma and using it as the draining fluid area; The deep brain stimulation electrode is set as the anode and the selected medical device electrode is set as the cathode; simulating the fluid transport process from the target tissue to the cerebrospinal fluid-filled space using the patient-specific three-dimensional head model, and Controlling fluid delivery, applying an electrical potential and / or current to the electrodes to control fluid delivery away from the edema and / or hematoma.

17. The medical device according to any one of the preceding claims, characterized in that The central nervous system / cerebrospinal fluid system suffers from a disease related to the central nervous system and needs to be treated by drug administration, and the medical device is configured to: Select the diseased tissue as the area to receive fluids and medications; Using the patient-individualized three-dimensional head model to simulate the transmission of fluid toward the diseased tissue; Controlling fluid transport, applying an electrical potential and / or current to the electrodes to control fluid transport for delivering the drug to the diseased tissue.

18. The medical device according to any one of claims 10 to 17, characterized in that The medical device is configured to control the application of electric potential and / or current to the electrodes to modulate neural plasticity and excitatory / inhibitory polarization of diseased tissue.

19. The medical device according to any one of the preceding claims, characterized in that The CNS / CSF system includes a brain suffering from cerebral edema, intracerebral hemorrhage, Alzheimer's disease, and / or Parkinson's disease, and the medical device includes controlling fluid delivery to drive at least one fluid from the diseased area to adjacent brain tissue and / or cerebrospinal fluid-filled spaces.

20. The medical device according to any one of the preceding claims, characterized in that The electrode system comprises at least two electrodes and at most 100 electrodes, which are arranged at intervals on the electrode system device, wherein each electrode can be set as an anode or a cathode according to the design method.

21. The medical device according to any one of the preceding claims, characterized in that The current used for treatment is direct current or alternating current with an average amplitude between 0.1 and 200 mA, thereby producing continuous stimulation, intermittent stimulation or hammer-type stimulation.

22. The medical device according to any one of the preceding claims, characterized in that The patient-specific three-dimensional head model includes a three-dimensional model of the central nervous system / cerebrospinal fluid system consisting of the brain and / or cerebrospinal fluid and / or scalp and / or ventricles and / or skull.

23. The medical device according to any one of the preceding claims, characterized in that An electrode system device (100, 200) and at least two spaced electrodes (101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 201, 202) are included to electrically communicate with the central nervous system / cerebrospinal fluid system to be treated.

24. The medical device according to claim 23, characterized in that The electrode system device (100, 200) is a mesh, cap or helmet-shaped device that can be installed on the head of a person to be treated.

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