Treatment devices

Abstract

The present invention relates to a method for inducing controlled fluid delivery in the central nervous system (CNS) and / or in the cerebrospinal fluid (CSF) system of a patient by electroosmosis (EO) via two or more electrodes (221, 222, 223, 224, 225, 226, 227, 231) placed at selected locations on the patient's head, the method comprising: receiving EO information indicating at least a fluid delivery response resulting from applying a specific electric potential and / or current at specific electrode locations on the patient's head based on a patient-specific three-dimensional head model; receiving a fluid source location within the patient's head; selecting a set of electrode locations using the EO information and the fluid source location; placing the two or more electrodes (221, 222, 223, 224, 225, 226, 227, 231) at the patient's head; and 224, 225, 226, 227, 231) are placed in electrical communication with the CNS / CSF system, each electrode being placed at one of the selected set of electrode locations; and controlling the application of a selected potential and / or current to the electrodes, wherein the selected potential and / or current are selected to be the potential and / or current associated with the set of electrode 15 locations selected based on the EO information to induce controlled fluid delivery in the CNS / CSF system.

Description

Technical Field

[0001] The present invention relates to methods, devices, computer program modules and systems for treating the central nervous system and / or cerebrospinal fluid system. In particular, the present invention relates to inducing fluid transport in said system by electroosmosis. Background Art

[0002] Cerebral edema, defined as an increase in water content in neural tissue, is a major neurologic complication of traumatic brain injury and stroke. Increased intracranial pressure is found in the majority of patients with cerebral edema and is likely to worsen unless effectively treated.

[0003] At present, corticosteroids or osmotic diuretics are usually used to treat cerebral edema. Especially, osmotic therapy has been regarded as the mainstay of drug treatment, but osmotic therapy can bring side effects, such as acute renal failure and reduced cerebral perfusion. In addition, when the mass effect of cerebral edema is too high to be controlled by osmotic therapy alone, neurosurgery (e.g., decompressive craniectomy) is the ultimate choice for patients with the most severe traumatic brain injury and stroke, in order to reduce the intracranial pressure caused by cerebral edema. Decompressive craniectomy does reduce the mortality rate, but improves the survival rate of severe disability and some patients are in a vegetative state, which may be caused by the severe stretching of the brain tissue at both the inside of the brain and the edge of the bone.

[0004] Thus, despite improvements in outcomes over the past few decades, there remains no definitive and successful treatment for cerebral edema and increased intracranial pressure. The central nervous system and / or cerebrospinal fluid system are susceptible to excessive fluid accumulation, such as, but not limited to, cerebral edema, which can damage the system. An efficient method for eliminating or reducing such fluid accumulation is needed.

[0005] US 2014 / 032412 and US 2017 / 0274207 describe a method for electroosmotically driving fluid to treat hydrocephalus. In this patent, two insulated electrodes are implanted in the brain to electroosmotically drive fluid flow between the first and second electrodes based on a capacitive current. This invasive method using implanted electrodes has the disadvantage of increasing the risks associated with implantation and operation of the system and may cause secondary damage to the brain near the implanted electrodes. Furthermore, the insulated electrodes are used to drive the induced fluid flow using a capacitive current. A disadvantage is that there is uncertainty about the effectiveness and efficiency of the capacitive current induced by the insulated electrodes, particularly when inducing fluid flow to move fluid over distances longer than a few centimeters.

[0006] US2019 / 0076653 describes a method for treating the accumulation of substances (such as amyloid beta and / or tau protein) in the brain using three electrodes. In this patent, substances are driven from the brain parenchyma into the cerebrospinal fluid-filled space of the brain based on the principles of electrophoresis and electroosmosis, and then driven to the superior sagittal sinus. A direct current with an average amplitude of at least 1 mA and not more than 5 mA or an average amplitude of less than 1.2 V is applied. However, the invasive method using implanted electrodes has the disadvantage of possibly causing secondary damage to the brain near the implanted electrodes. In addition, the amplitude can cause electrolysis around the implanted electrodes, which can damage the brain.

[0007] In US9616221, a method is described for treating a subject identified as at risk for or suffering from Alzheimer's disease by electroosmotically driving fluid from the subarachnoid space to the superior sagittal sinus. A midface treatment electrode is positioned above the superior sagittal sinus, and a lateral treatment electrode is positioned between 1 cm and 12 cm of the midsagittal plane of the skull. However, the electrodes are configured to drive the fluid flow from the subarachnoid space to the superior sagittal sinus. Therefore, only minimal effects will be exerted on the superficial gray matter of the brain and negligible effects will be exerted on the deep white matter. A disadvantage of having treatment electrodes located at fixed positions rather than at specific electrode locations based on the location of the fluid source within the patient's head is that fluid transport in the central nervous system and / or cerebrospinal fluid system cannot be controlled.

[0008] Furthermore, none of the prior art identifies key information that influences electroosmosis, such as the fluid delivery response resulting from application of a specific electrical potential and / or current at a specific electrode location on the patient's head or at a fluid source location within the patient's head, all of which are important parameters for inducing controlled fluid delivery in the patient's central nervous system and / or cerebrospinal fluid system via electroosmosis. Therefore, there is a need for an improved, non-invasive method for controlling or regulating fluid flow in the central nervous system and / or cerebrospinal fluid system for use in a wide variety of neurological disorders, such as, but not limited to, the treatment of cerebral edema (both localized and diffuse) at various locations.

[0009] Specifically for the treatment of edema, the method can be used as a supplement to treat patients who have undergone decompressive craniectomy to reduce the size and duration of edema, thereby improving patient outcomes. Furthermore, the method can be used as a novel non-invasive therapy to remove excess edema fluid that would obviate decompressive craniectomy, or as a supplement to the limited treatment options currently available to patients with moderate or mild cerebral edema. Summary of the Invention

[0010] The above-referenced problems and other problems may be alleviated using a method, apparatus, computer program module or system according to any one of the appended claims.

[0011] According to a first aspect of the present invention, there is provided a method for inducing controlled fluid delivery in a patient's central nervous system (CNS) and / or cerebrospinal fluid (CSF) system by electroosmosis (EO) via two or more electrodes placed at selected locations on the patient's head, the method comprising: receiving EO information, the EO information at least indicating a fluid delivery response resulting from application of a specific potential and / or current at a specific electrode location on the patient's head based on a patient-specific three-dimensional head model; receiving a fluid source location within the patient's head; selecting a set of electrode locations using the EO information and the fluid source location; placing the two or more electrodes in electrical communication with the CNS / CSF system, with each electrode placed at one of the selected set of electrode locations; and controlling 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 set of electrode locations selected based on the EO information, to induce controlled fluid delivery in the CNS / CSF system.

[0012] According to a second aspect of the present invention, there is provided a method for inducing controlled fluid transport in the central nervous system (CNS) and / or in the cerebrospinal fluid (CSF) system by electroosmosis. The method comprises:

[0013] a) receiving information regarding electrode positions and / or electrode potentials and / or electrode currents selected to achieve controlled fluid delivery in the CNS / CSF system, wherein the information is generated by computer simulation of induced fluid delivery in a computer model of the CNS / CSF system, the computer model being generated based on a set of image scans of the CNS / CSF system and the simulation being performed by simulating in the computer model a fluid delivery response resulting from application of potentials and / or currents via at least one simulated anode and at least one simulated cathode placed in electrical communication with the CNS / CSF system,

[0014] b) placing at least two electrodes in electrical communication with the CNS / CSF system, and

[0015] c) controlling, using a control unit, the application of electrical potentials and / or currents to the electrodes based on information received from the computer simulation to induce controlled fluid delivery in the CNS / CSF system.

[0016] Preferably, the method comprises placing at least one electrode serving as a cathode and at least one electrode serving as an anode at positions corresponding to the positions of the simulated cathode / anode. Preferably, the method comprises applying an electric potential and / or current to the electrodes placed at positions corresponding to the positions of the simulated cathode / anode. Preferably, the method comprises applying to the electrodes an electric potential and / or current corresponding to the simulated electric potential and / or current applied to the simulated electrodes. Preferably, the method comprises controlling the application of the electric potential and / or current to the electrodes based on at least one simulation result in the information received from the computer simulation.

[0017] According to one embodiment, the method comprises selecting a region of the CNS / CSF system from which fluid is to be withdrawn and selecting a region of the CNS / CSF system from which fluid is to be received, and the method step b) comprises:

[0018] b1) placing at least one cathode in electrical communication with the CNS / CSF system in an orientation behind the zone to receive fluid as viewed from the zone to be withdrawn, and

[0019] b2) placing at least one anode in electrical communication with the CNS / CSF system in a spaced-apart orientation behind the zone from which fluid is to be withdrawn, as viewed from the zone from which fluid is to be received.

[0020] Preferably, the district that will receive fluid is a cerebral ventricle (such as a cerebrospinal fluid ventricle, such as the lateral ventricle in the brain) and / or the superior sagittal sinus. In one embodiment, the method includes selecting the access district of the CNS / CSF system. The access district preferably includes a district between the district from which fluid will be extracted and the district from which the fluid will be received, and the access district forms a preferred path for fluid flow between the district from which fluid will be extracted and the district from which the fluid will be received. In one embodiment, the method includes selecting a lateral district, which is located next to the district to be extracted, the access district, and the district from which fluid will be received.

[0021] In one embodiment, the method comprises selecting a region of the CNS / CSF system in which fluid flow and / or fluid accumulation should be avoided. In one embodiment, the lateral region coincides with the region in which fluid flow and / or fluid accumulation should be avoided.

[0022] In one embodiment, method step c) comprises:

[0023] c1) using a control unit to control the application of potential and / or current to at least one cathode and at least one anode to focus fluid transport from the zone selected to be drawn from the fluid towards the zone selected to be received by the fluid.

[0024] By focusing the fluid flow, it is possible to avoid accumulation of fluid above a threshold that risks damaging tissue and / or flow of fluid above a threshold that would risk damaging tissue in areas of biological tissue where fluid delivery is to be avoided. Thus, fluid delivery from the area to be withdrawn to the area receiving the fluid is focused to a selected pathway to prevent secondary fluid flow or delivery to adjacent areas or to areas where fluid flow is to be avoided.

[0025] By considering the following detailed description of one or more embodiments, those skilled in the art will obtain a more complete understanding of the embodiments of the present invention and realize the additional advantages of the present invention.It should be understood that similar reference numerals are used in one or more of the figures to identify similar elements illustrated. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 The patient-specific treatment process of the present invention is shown.

[0027] Figures 2A to 2E Various therapeutic devices according to aspects of the present invention are shown.

[0028] Figure 3 Shown are image scans of patient #1, computer simulation results, and an apparatus according to aspects of the present invention.

[0029] Figure 4 Additional image scans of patient #1, computer simulation results, and devices according to aspects of the present invention are shown.

[0030] Figure 5 Additional image scans, computer simulation results, and devices for patient #2 are shown according to aspects of the present invention.

[0031] Figure 6 Additional image scans, computer simulation results, and devices for patient #3 are shown according to aspects of the present invention.

[0032] FIG. 7 shows a computer simulation and computer model of the CNS / CSF system taking into account, inter alia, fiber orientation.

[0033] Figure 8 A flow chart illustrating a method of treating a patient.

[0034] Figure 9 Shows the components and working process of the control unit.

[0035] By considering the following detailed description of one or more embodiments, those skilled in the art will obtain a more complete understanding of the embodiments of the present invention and realize the additional advantages of the present invention.It should be understood that similar reference numerals are used in one or more of the figures to identify similar elements illustrated. DETAILED DESCRIPTION

[0036] In the present disclosure, the term "colloidal lymph flow" refers to the flow of fluid in the colloidal lymphatic system and / or the colloidal lymphatic interstitial pathways and / or the paravascular system.

[0037] In the present disclosure, the term "modulating colloidal lymph flow" refers to changing / altering the direction or speed of colloidal lymph flow and is used interchangeably with "altering colloidal lymph flow" or "changing colloidal lymph flow."

[0038] In this disclosure, the term "electroosmosis" may be used interchangeably with electroosmotic flow, electro-osmotic flow, electroosmosis, or electroendosmosis, and refers to the movement of a fluid induced by an electric potential applied across a porous material or any other fluid conduit.

[0039] In the present disclosure, the term "patient-specific three-dimensional head model" refers to a model that is capable of providing a fluid delivery response given input parameters (such as selected potentials and / or currents applied at selected electrode locations on the patient's head). In other words, the fluid delivery response represents controlled fluid delivery in the CNS / CSF system. In the present disclosure, the terms "computer model," "computer model of the CNS / CSF system," and "patient-specific three-dimensional head model" are used interchangeably. The patient-specific three-dimensional head model may include models of how various parts of the patient's head respond to given input parameters, such as a model of the fiber structure within the CNS / CSF system, a skin model, a skull model, a body membrane model, models / information of damaged and healthy neural tissue, a brain model, a cerebrospinal fluid model, a brain ventricle model, a model of white brain tissue, a model of gray brain tissue, a brainstem model, and a spinal cord model. The model may, for example, include values ​​for electrical material parameters (such as conductivity and / or dielectric constant).

[0040] In this disclosure, the term "image scan" refers to the output / results of an imaging system used on and aimed at a patient's head, such as a set of computed tomography (CT) image scans and / or a set of multimodal medical image scans, such as magnetic resonance imaging (MRI) image scans, and / or ultrasound image scans, and / or positron emission tomography (PET) image scans.

[0041] In this disclosure, the term "posterior" when used to describe the positioning of an electrode refers to a relative position along the surface of the patient's head. In other words, at the location where a straight line from a fluid target location (such as the superior sagittal sinus) through a fluid source location (such as an edema) intersects the surface of the patient's head.

[0042] According to one aspect, the present invention relates to the treatment of fluid disturbances, such as edema, based on the electro-osmotic properties of tissue that allow the channeling of edema fluid when electrodes are applied to the patient's head.

[0043] A technical solution is provided that uses, in some embodiments, a helmet-like medical device developed for edema treatment ( FIG2 ), which applies specific electrical potentials and / or currents at specific or predefined electrode locations on the patient's head.

[0044] The mechanism behind the present invention is the electroosmotic property of the brain: electroosmotic flow can be induced by an electric field when electrodes are applied. By activating the electrodes in a designed manner, the present invention can treat different types of edema in various locations (including localized brain edema and diffuse brain edema) and is expected to be effective against various types of edema (including vasogenic edema and cytotoxic edema). The present invention can also be used to modify / regulate colloidal lymphatic flow. The present invention allows for targeted treatment by targeting the desired tissue area and activating the electrodes based on simulation results of a patient-specific three-dimensional head model to direct fluid along a preferred path to avoid unnecessary interference with a relatively healthy brain. For patients with localized edema, for example, fluid in the edematous tissue can be directed to the superior sagittal sinus, which absorbs cerebrospinal fluid, or to the lateral ventricles, where it enters the cerebrospinal fluid circulation. For patients with diffuse edema, for example, fluid in the edematous tissue can be directed to the superior sagittal sinus. Helmet-type devices are not suitable for patients with enlarged brains due to craniotomy during decompressive craniectomy. Instead, a novel design is proposed to apply electrodes directly to the dura mater at selected electrode locations and, for example, to direct fluid in edematous tissue to the superior sagittal sinus.

[0045] Figure 2A The diagram in FIG. 2 illustrates the use of a cathode / anode helmet-like device 210 for edema treatment. Figure 2B The diagram illustrates the application of the present disclosure to deliver fluid from localized edema 250 to the superior sagittal sinus. Figure 2C The diagram illustrates the application of the present disclosure to deliver fluid from localized edema to the ventricles of the brain. Figure 2D The diagram illustrates the application of the present disclosure to deliver fluid from diffuse edema to the superior sagittal sinus. Figure 2E The diagram illustrates the application of the present disclosure to deliver fluid from localized edema to the superior sagittal sinus following decompressive craniectomy.

[0046] Three patients #1-#3 were used to illustrate the concept. Figure 3 and Figure 4 Patient #1 shown in FIGURE 1 illustrates the initiation of electrodes to guide the electrodes to the superior sagittal sinus and ventricles ( Figure 2B and Figure 2C ) to treat localized brain edema. Figure 5Patient #2 shown in FIGURE 2 illustrates the initiation of electrodes to guide the electrodes to the superior sagittal sinus ( Figure 2D ) to treat diffuse cerebral edema. Figure 6 Patient #3 shown in FIGURE 3 illustrates the initiation of electrodes to guide the superior sagittal sinus ( Figure 2E ) to treat localized cerebral edema.

[0047] Figures 2A to 2D A helmet-like device 210 ( Figure 2A ), the helmet-like device 210 is capable of treating localized edema 250 ( Figure 2B and Figure 2C ) and diffuse edema ( Figure 2D ).

[0048] exist Figures 2A to 2D In the example, the activated electrodes are illustrated as hatched, while the inactive electrodes are illustrated as blank or unfilled. Figure 2B and Figure 2D ), the electrode illustrated in a circular shape may be an anode electrode, and the electrode illustrated in a rectangular shape may be a cathode electrode. In one example ( Figure 2C ), the electrodes illustrated in a circular shape may be an anode electrode and a cathode electrode.

[0049] Designed specifically for enlarged brains that are not suitable for helmet use, and Figure 2E The individual designs are illustrated in FIG.

[0050] According to one aspect, the present invention includes a method for treating edema using the electroosmotic properties of tissue and applying electrodes based on a CT image of a patient, the method comprising:

[0051] a) obtaining a CT image of the patient's brain;

[0052] b) generating a patient-specific three-dimensional model of the patient's head including an edema component based on the CT image using a helmet-like device and producing a computer simulation simulating the patient-specific three-dimensional model;

[0053] c) selecting appropriate electrodes for activation based on simulation results of the patient-specific 3D model;

[0054] d) Place the helmet-like device on the patient's head and activate selected electrodes to drive edema fluid from the edema area to the superior sagittal sinus or lateral ventricle.

[0055] According to one embodiment, a mask / helmet-like device provided with electrodes positioned at predetermined locations is designed to activate different selected electrodes based on desired targets from a patient's CT image. The mask / helmet-like device includes a plurality of electrodes. For example, the mask / helmet-like device may include 13 electrodes, a control unit, and a mask / helmet-like shell or mechanically connected body. The electrode configuration (e.g., distance and required voltage) for the anode and cathode electrodes is determined based on a patient-specific three-dimensional head model. For patients with an enlarged brain due to a decompressive craniectomy, an electrode (e.g., a rectangular electrode) is applied to the dura mater and another rectangular electrode is applied to the superior sagittal sinus. The treatment focus is controlled by adjusting the position of the electrodes based on simulation results or fluid delivery response using the patient-specific three-dimensional head model. When using the helmet-like device, this includes selecting which electrodes to activate as anode and / or cathode electrodes. Integrated diffusion tensor imaging (DTI) during numerical simulation of the patient-specific three-dimensional head model will improve the accuracy of the treatment focus. The method can be used to treat both localized and diffuse edema and is suitable for patients undergoing craniotomy.

[0056] Figure 3 A CT image 310 of patient #1 with localized cerebral edema is shown and used to generate a patient-specific head model including the edema (right column). The anode electrodes 224-226 and cathode electrode 231 are activated to direct edema tissue fluid to the superior sagittal sinus (left column).

[0057] Figure 4 A CT image 310 of patient #1 is shown, showing localized cerebral edema, which is used to generate a patient-specific head model including the edema (right column). The anode electrodes 224-226 and cathode electrodes 221-223 are activated to direct edema tissue fluid into the ventricles (left column).

[0058] Figure 5 A CT image 410 of patient #2 is shown, showing diffuse cerebral edema, which is used to generate a patient-specific head model including the edema (right column). The anode electrodes 221-223, 225 and the cathode electrode 231 are activated to direct the edematous tissue to the superior sagittal sinus (left column).

[0059] Figure 6 Patient #3 is shown having undergone a decompressive craniectomy, a procedure in which the brain is expanded outside the skull to relieve intracranial pressure. CT images 510 are used as input to generate a patient-specific head model with the brain expanded (right column). An anode electrode 227 is applied to the dura mater surface to direct edema tissue fluid to the superior sagittal sinus (left column).

[0060] Figures 7A to 7DSeveral examples are shown to illustrate how DTI allows for better optimization of fluid flow paths. Figure 7A Illustration showing the case where fiber orientation is not considered in the simulation. Figure 7B The graphic illustrates that accounting for fiber orientation in the model allows for better optimization of fluid flow. Figure 7C Graph illustrating velocity values ​​for electro-osmotic fluid flow. Figure 7D The diagram illustrates taking the fiber direction into account during the simulation by including DTI information into the model. It shows that the fluid flow moves faster along the fiber direction and slower perpendicular to the fiber direction.

[0061] According to one embodiment, there is a method for inducing controlled fluid transport in the central nervous system (CNS) and / or in the cerebrospinal fluid (CSF) system by electroosmosis, the method comprising:

[0062] a) receiving information regarding electrode positions and / or electrode potentials and / or electrode currents selected to achieve controlled fluid delivery in the CNS / CSF system, wherein the information is generated by computer simulation of induced fluid delivery in a computer model of the CNS / CSF system, the computer model being generated based on a set of image scans of the CNS / CSF system, and the simulation being performed by simulating in the computer model a fluid delivery response resulting from application of an electrical potential and / or current through at least one simulated anode and at least one simulated cathode placed in electrical communication with the CNS / CSF system,

[0063] b) placing two or more electrodes (anodic and / or cathodic) in electrical communication with the CNS / CSF system, and

[0064] c) controlling, using a control unit, the application of electrical potentials and / or currents to the electrodes based on information received from the computer simulation to induce controlled fluid delivery in the CNS / CSF system.

[0065] According to one embodiment, the invention comprises placing two or more electrodes in electrical communication with the portion of the CNS at locations that are more than 50% identical to the locations of corresponding simulated electrodes in the computer model. According to one embodiment, the invention comprises placing electrodes at locations that are more than 70% identical to the locations of the simulated electrodes.

[0066] According to one embodiment, the present invention comprises placing electrodes at positions that are more than 85% consistent with the positions of simulated electrodes. According to one embodiment, the present invention comprises placing electrodes at positions that are more than 90% consistent with the positions of simulated electrodes. According to one embodiment, the present invention comprises placing electrodes at positions that are more than 95% consistent with the positions of simulated electrodes. Adding more electrodes allows for better and more fine-tuned control of the resulting electric field and / or resulting current within the CNS / CSF system. It also allows for a higher probability of the electrodes being at the desired location when the electrodes are placed in a fixed position on a device that will be placed on the CNS / CSF system.

[0067] According to one embodiment, the method / apparatus / system comprises controlling the potential and / or current so that an electrode placed in an orientation consistent with a simulated anode functions as an anode and an electrode placed in an orientation consistent with a simulated cathode functions as a cathode. According to one embodiment, the computer model comprises at least four simulated electrodes, at least three of the at least four simulated electrodes are designated to function as anodes and at least one electrode is designated to function as a cathode, and method step d) comprises placing at least four electrodes in electrical communication with the portion of the CNS, at least three of the at least four electrodes functioning as anodes and at least one electrode functioning as a cathode. According to one embodiment, the method / apparatus system comprises at least two electrodes, and at least one electrode is designated to function as a cathode and at least one electrode is designated to function as an anode.

[0068] According to one embodiment, the subject to be treated is an animal belonging to the family of vertebrates. According to one embodiment, there is a subject with a central nervous system (CNS) and / or cerebrospinal fluid (CSF) system to be treated. For example, the central nervous system may have been damaged. According to one embodiment, the subject to be treated is a human.

[0069] According to one embodiment, the term 'in electrical communication with' means that at least 1 / 10 of the electric field from the electrode penetrates into the tissue in electrical communication with the electrode. Alternatively, the term electrical communication may mean that at least 1 / 10 of the current from the electrode penetrates into the tissue in electrical communication with the electrode. Preferably, at least 1 / 3 of the field strength and / or current penetrates into the tissue, and alternatively, at least 50% of the field strength or current penetrates into the tissue. Alternatively, the term electrical communication may mean that the applied potential or current is capable of affecting fluid transport in the CNS / CSF system to an extent that produces a therapeutic effect. Alternatively, the term electrical communication means that the applied potential or current is capable of achieving at least 1 nl / min*cm due to electroosmosis. 2 Preferably, the method comprises placing electrodes on the individual in electrical communication with the CNS / CSF system of the individual.

[0070] According to one embodiment, the method comprises selecting a region of the CNS / CSF system from which fluid is to be withdrawn and selecting a region of the CNS / CSF system from which fluid is to be received, and the method step b) comprises:

[0071] b1) placing at least one cathode in electrical communication with the CNS / CSF system in an orientation behind the area from which the fluid is to be withdrawn, and

[0072] b2) placing at least one anode in electrical communication with the CNS / CSF system in a spaced-apart orientation behind the area from which fluid is to be withdrawn, as viewed from the area from which fluid is to be received.

[0073] According to one embodiment, the method comprises in step c):

[0074] c1) using a control unit to control the application of potential and / or current to at least one cathode and at least one anode to focus fluid transport from the zone selected to be drawn from the fluid towards the zone selected to be received by the fluid.

[0075] Preferably, the method includes positioning at least one first anode to at least partially cover the region of the CNS from which fluid is to be withdrawn, and positioning at least one second anode to at least partially cover a flanking region adjacent to the region from which fluid is to be withdrawn, wherein the first anode and the second anode constitute the first anode component and the second anode component, respectively. Preferably, the method includes applying an electric potential or current to the first anode and / or the second anode separately. In one embodiment, different electric potentials / current intensities are applied to the first and second electrodes. This allows for fine-tuning the fluid flow to a predetermined path of the fluid. According to one embodiment, the method includes positioning at least one first anode to at least partially cover the region of the CNS from which fluid is to be withdrawn, and positioning at least one second and third anodes to at least partially cover a flanking region adjacent to the region from which fluid is to be withdrawn. This allows for stopping the flow of fluid into the flanking region. Preferably, at least one anode is positioned such that the electric field and / or current from the anode penetrates into the region from which fluid is to be withdrawn, thereby allowing electroosmosis and allowing fluid to flow out of the region from which fluid is to be withdrawn.

[0076] According to one embodiment, the image scan is one of a CT image scan, a PET image scan and / or a MR image scan.According to one embodiment, the set of image scans is a set of CT image scans.

[0077] According to one embodiment, the method / computer program module further comprises:

[0078] a1) receiving in a computer memory at least one set of image scans of a CNS / CSF system,

[0079] a2) generating a computer model of the CNS / CSF system based on the received set of image scans, and

[0080] a3) using a computer to simulate fluid transport in a computer model of the CNS / CSF system in response to application of an electric potential and / or electric current via at least one simulated anode and at least one simulated cathode placed in electrical communication with the CNS / CSF system.

[0081] In one embodiment, the method also includes obtaining a CT image scan of the individual to be treated. Preferably, the method includes performing several simulations based on the same model of the individual using various positions of electrodes and / or various potentials applied to the electrodes. This allows for selecting a path for the fluid flow, thereby generating high fluid transport toward the receiving area. It may also allow for selecting a path for the fluid flow to avoid damaging tissue. It may also allow for selecting a path for the fluid flow to avoid secondary fluid flow entering the collateral area. Preferably, the simulation is a simulation of fluid transport induced in the CNS / CSF system via electroosmosis, which is obtained by applying an electric potential and / or current to generate an electric field. The electric field and / or current can drive the fluid flow through the electroosmotic process. Preferably, the method includes using the electrodes to control the fluid flow using the fluid flow induced by electroosmosis.

[0082] In one embodiment, the computer model / patient-specific three-dimensional head model includes a 3D model of the CNS / CSF system. In one embodiment, the computer model of the CNS / CSF system includes information about the fiber structure within the CNS / CSF system. The fiber structure within the brain tissue can cause the fluid flow to be diverted from the direction of the applied electric field to the fiber direction. By including the fiber structure in the computer model used to simulate fluid flow, the fiber structure can be taken into account. 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 values ​​of electrical material parameters (such as conductivity and / or dielectric constant). According to one embodiment, the computer model includes a model of a body membrane. Preferably, the computer model includes values ​​of fluid material parameters (such as membrane permeability). Preferably, the computer model includes values ​​of permeability parameters (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 neural tissue and healthy neural tissue may have different material parameters, which can be simulated in the model. Preferably, the method includes identifying and classifying damaged neural tissue and healthy neural tissue based on a CT image scan. Alternatively, the method may include receiving information about damaged neural tissue and healthy neural tissue. According to one embodiment, the computer model includes a 3D model of the brain, cerebrospinal fluid, cerebral ventricles, skull and scalp. In one embodiment, the computer model of the portion of the CNS / CSF system includes a model of white brain tissue and gray brain tissue. In an alternative embodiment, the computer model includes a model of a portion of the brainstem and / or spinal cord and nearby bones.

[0083] According to one embodiment, the method comprises placing one or more anodes in a position behind the area from which the fluid is to be withdrawn, as viewed from the area from which the fluid is to be withdrawn. According to one embodiment, the CNS / CSF system is suffering from edema, and the method comprises

[0084] - select edema 250 as the area from which fluid will be withdrawn,

[0085] - simulating fluid transport in a direction away from the edema, and

[0086] - Controlling fluid delivery and application of electrical potential and / or current to the electrodes to control fluid delivery away from edema.

[0087] Thus, edema is the area from which fluid is to be extracted. According to one embodiment, the method comprises placing at least one first anode component to cover the edema, and placing at least one second anode component to cover the lateral area next to the edema. Preferably, the method comprises controlling fluid transport and the application of electrical potential and / or current to drive at least one fluid toward a natural drainage channel. The fluid can be blood, cerebrospinal fluid or spinal fluid. Preferably, the method comprises controlling fluid transport in the individual in a direction from the edema to the CSF system. According to one embodiment, the CNS / CSF system comprises a brain suffering from edema, and the method comprises controlling fluid transport to drive at least one fluid away from the edema toward the lateral ventricles and / or toward the superior sagittal sinus. Alternatively, the portion of the CNS comprises a portion of the brainstem and / or spinal cord suffering from edema, and the method comprises controlling fluid transport to drive at least one fluid toward the spinal canal away from the edema.

[0088] According to one embodiment, the method includes placing a device comprising a mechanically connected body and at least four spaced-apart electrodes (e.g., a helmet-like device with electrodes placed at predetermined locations / orientations on the mechanically connected body) in electrical communication with the CNS / CSF system to be treated.

[0089] According to one embodiment, the method comprises placing a device comprising a mechanically connected body and at least four spaced-apart electrodes on the CNS / CSF system to be treated. In one embodiment, the method comprises placing the device on a vertebra. In one embodiment, the method comprises placing the device on an animal. In one embodiment, the method comprises placing the device on an individual. In one embodiment, the method comprises placing the device on a human. In one embodiment, the method comprises placing the device on a patient. In one embodiment, the method comprises placing, in step d), a device comprising at least one anode and at least one cathode in a fixed, designated orientation on the portion of the CNS / CSF system to be treated.

[0090] According to one embodiment, the method includes placing a device on the CNS / CSF system, and the device is a net, hood or helmet configured to be attached to the head of the individual to be treated. Alternatively, the device is hood or helmet-shaped to be attached to the head of the individual to be treated. Preferably, the device is helmet-shaped to be attached to the head of the individual to be treated. Alternatively, the device is hood-shaped to be attached to the head of the individual to be treated. In one embodiment, the device may include a free electrode that can be placed on the CNS / CSF system. In one embodiment, the free electrode can be attached to the device. In one embodiment, the free electrode can be repositioned relative to the device and / or can be removed and reattached to the device.

[0091] According to one aspect, the present invention includes an apparatus for inducing controlled fluid transport in a central nervous system (CNS) and / or in a cerebrospinal fluid (CSF) system by electroosmosis, the apparatus comprising a mechanical connection body, at least two electrodes spaced apart and arranged on the mechanical connection body, and electrical wiring, wherein the mechanical connection body and electrodes are configured to be placed on the CNS / CSF system to establish electrical communication between the electrodes and the CNS / CSF system according to method step b), and the wiring is configured to allow control of the electrodes by a control unit according to method step c).

[0092] According to one embodiment, the device comprises at least three electrodes arranged at intervals on the mechanical connection body, at least two of the at least three electrodes being intended to be used as anodes and at least one being intended to be used as cathodes. According to one embodiment, the device comprises at least four electrodes arranged at intervals on the mechanical connection body, at least three of the at least four electrodes being intended to be used as anodes and at least one being intended to be used as cathodes. Preferably, the device comprises at least five electrodes, at least four of the at least five electrodes being intended to be used as anodes and at least one being intended to be used as cathodes. Preferably, the device comprises at least 8 electrodes, at least seven of the at least eight electrodes being intended to be used as anodes and at least one being intended to be used as cathodes. Preferably, the device comprises at least 11 electrodes, at least 10 of the at least 11 electrodes being intended to be used as anodes and at least one being intended to be used as cathodes. Preferably, the device comprises at least 14 electrodes, at least 13 of the at least 14 electrodes being intended to be used as anodes and at least one being intended to be used as cathodes.

[0093] According to one embodiment, the device comprises at least one set of electrodes arranged in a row along the mechanically connected body. In one embodiment, the device comprises a second set of electrodes arranged in a second row along the mechanically connected body. Preferably, the set of electrodes arranged in a row is intended to function as an anode. According to one embodiment, the device comprises a set of electrodes arranged along the perimeter of the mechanically connected body. Thus, the device can apply an electric field along its perimeter toward the CNS / CSF system from all directions. This allows for better and more fine-tuned control of the fluid flow induced within the CNS / CSF system.

[0094] According to one embodiment, at least one electrode is arranged to be placed on the top of the individual's head. Preferably, the electrode placed on the top of the head is a cathode and generates fluid flow toward the superior sagittal sinus. In one embodiment, the device includes at least one additional cathode positioned to allow fluid flow to be drawn toward the lateral ventricles. Preferably, the device is configured so that when the device is placed on the individual, the electrode is placed in electrical communication with the individual's CNS / CSF system, preferably placed on the individual's head. Preferably, the device includes at least one electrode intended to serve as a cathode, and the cathode is arranged to be positioned on the top of the individual's head when the device is in use. In one embodiment, at least one electrode is placed on the individual's dura mater. This may occur if the individual suffers from severe skull damage. In preferred treatments, the device is configured so that when the device is placed on the individual's head, at least some of the electrodes are placed in electrical communication with the individual's skull. In one embodiment, the device is configured so that when the device is placed on the individual, the electrodes are placed in electrical communication with the individual's skin.

[0095] According to one embodiment, the mechanical connection body is a mesh, cover or helmet that is configured to fit over the head of the individual to be treated and establish electrical communication between the electrodes of the device and the individual's CNS / CSF system at predetermined locations.

[0096] Preferably, the device comprises wiring configured to electrically connect the electrodes to one or more potential and / or current generators. The wiring may comprise an electrical network and electrical contacts, the electrical contacts allowing connection to one or more potential and / or current generators. According to one embodiment, the wiring is configured to allow individual control of the potential and / or current applied to at least two groups of electrodes in the device. Preferably, at least one group comprises one or more electrodes each configured to act as a cathode, and at least one group comprises one or more electrodes each configured to act as an anode. Preferably, the wiring is configured so that each group of anodes can be controlled individually relative to the other group. According to one embodiment, the device is configured to allow individual control of the potential and / or current applied to each individual electrode. Preferably, the wiring is configured to allow individual control of each group of electrodes.

[0097] According to one aspect, the present invention comprises a computer program module configured to induce a computer to perform any of the method steps described herein, such as method steps a1) to a3).

[0098] According to one aspect, the present invention comprises a computer program module configured to induce a computer or system to perform any of the method steps described herein, such as method steps a1) to a3), a) and c).

[0099] According to one embodiment, the computer program modules are configured to induce a computer to perform one or more further method steps appended to the claims.

[0100] A computer program module may comprise a subroutine of a computer program, a computer program, a computer or microcontroller programmed with the computer program, or a computer program product, such as a computer program memory in which the computer program is stored.

[0101] According to one aspect, the present invention comprises a system for inducing controlled fluid transport in the central nervous system (CNS) and / or in the cerebrospinal fluid (CSF) system by electroosmosis, the system comprising:

[0102] - a device comprising at least two electrodes adapted to be placed in electrical communication with the central nervous system (CNS) and / or cerebrospinal fluid (CSF) system,

[0103] - a control unit configured to control the application of electric potentials and / or currents to the electrodes in the device, and

[0104] - A computer program module configured to receive the information indicated in method step a) of claim 1 and to control the control unit to perform method step c).

[0105] According to one embodiment, the system comprises a computer program module configured to perform method steps a1) to a3).

[0106] According to an embodiment, the system comprises an apparatus according to any one of the apparatus claims in the accompanying claims.

[0107] According to one embodiment, the system comprises a control unit comprising one or more potential and / or current generators configured to supply potentials and / or currents to electrodes of the device according to the method of claim 1 .

[0108] The invention is not limited to the detailed description, examples and figures, but may be varied freely within the framework of the following claims. Specifically, features disclosed with reference to the method of the invention may be freely adapted, where applicable, for use in a device, system or computer program model, and vice versa.

[0109] Figure 8 A flow chart illustrating a method 800 according to one or more embodiments of the present disclosure is provided. The method is for inducing controlled fluid delivery in a patient's central nervous system (CNS) and / or cerebrospinal fluid (CSF) system by electroosmotic EO via two or more electrodes placed at selected locations on the patient's head, the method comprising:

[0110] Step 810: Receive EO information indicating at least a fluid delivery response resulting from applying specific electrical potentials and / or currents at specific electrode locations on the patient's head based on a patient-specific three-dimensional head model.

[0111] In one embodiment, the EO information includes information regarding electrode locations and / or electrode potentials and / or electrode currents selected to achieve controlled fluid delivery or a fluid delivery response in the CNS / CSF system.

[0112] In one embodiment, the EO information is received by generating the EO information by computer simulation of induced fluid transport in a patient-specific three-dimensional head model of the CNS / CSF system.

[0113] The patient-specific three-dimensional head model is typically generated based on a set of image scans of the CNS / CSF system. The simulation is typically performed by simulating a fluid delivery response resulting from applying an electric potential and / or current through at least one simulated anode electrode and at least one simulated cathode electrode positioned in electrical communication with the CNS / CSF system of the patient-specific three-dimensional head model.

[0114] In other words, a simulation is performed using a patient-specific three-dimensional head model, assuming electrodes are placed at a selected set of electrode locations, and applying associated specific potentials and / or currents at specific electrode locations on the patient's head. By evaluating the patient-specific three-dimensional head model at the specific potentials and / or currents, a fluid delivery response can be obtained. This typically indicates the flow of fluid from a fluid source location to a fluid target location (e.g., from an edema to the superior sagittal sinus).

[0115] In one embodiment, the EO information is received by retrieving predetermined EO information from memory (eg, from an established database / lookup table and / or from historical simulations).

[0116] In one embodiment, the EO information is received by receiving user input from an input device, such as a clinician typing in selected electrode locations and / or potentials and / or currents based on past patient treatment experience.

[0117] Step 820: Receive the location of a fluid source within the patient's head. The fluid location is derived from a set of image scans of the CNS / CSF system or entered by the user via an input device.

[0118] Step 830: Select a set of electrode positions using the EO information and the fluid source location. The electrode positions may be selected as positions that provide a desired or optimal fluid delivery response among a set of electrode positions given the EO information.

[0119] In one embodiment, the step of selecting a set of electrode locations further comprises designating each location as a cathode or anode location to which a specific potential and / or current should be applied.

[0120] Step 840: Placing two or more electrodes in electrical communication with the CNS / CSF system, each electrode being placed at one of the selected set of electrode locations.

[0121] In other words, two or more electrodes are attached to the patient's head at said selected set of electrode positions. If the helmet-like device is provided with a plurality of electrodes having predetermined electrode positions, a set or a sub-set of said plurality of electrodes may be activated, as described with reference to Figures 2A to 2D Further illustration in .

[0122] Step 850: Controlling application of selected potentials and / or currents to the electrodes, wherein the selected potentials and / or currents are selected to be associated with the set of electrode locations selected based on the EO information, thereby causing controlled fluid delivery in the CNS / CSF system.

[0123] In one embodiment, the method further comprises: selecting an area of ​​the CNS / CSF system from which fluid is to be withdrawn; and receiving the fluid at a target location as the location of the selected area of ​​the CNS / CSF system from which fluid is to be withdrawn. Furthermore, the step of placing electrodes comprises: b1) placing at least one cathode electrode in electrical communication with the CNS / CSF system in an orientation, e.g., posterior to the area from which fluid is to be withdrawn, as viewed from the area from which fluid is to be withdrawn; and b2) placing at least one anode electrode in electrical communication with the CNS / CSF system in a spaced-apart orientation, e.g., posterior to the area from which fluid is to be withdrawn, as viewed from the area from which fluid is to be withdrawn (e.g., the superior sagittal sinus).

[0124] In one embodiment, the controlling step 850 also includes c1) controlling the application of an electric potential and / or current to at least one cathode electrode and at least one anode electrode, for example using a control unit, to focus fluid transport from the area selected to be drawn from the fluid toward the area selected to be received by the fluid.

[0125] In one example, fluid delivery is focused from the zone toward a fluid target location.

[0126] In one embodiment, the set of image scans is a set of CT image scans and / or a set of multimodal medical image scans, such as magnetic resonance imaging (MRI) image scans, and / or ultrasound image scans, and / or positron emission tomography (PET) image scans. It should be understood that other suitable or available methods of obtaining image scans may be used without departing from the present disclosure.

[0127] In one embodiment, the patient-specific three-dimensional head model of the CNS / CSF system is generated using the set of image scans. In this embodiment, the method further comprises: a1) receiving at least one set of image scans of the CNS / CSF system in a computer memory; a2) generating a patient-specific three-dimensional head model of the CNS / CSF system based on the received set of image scans, for example, by smoothing voxels; and a3) using the computer to simulate fluid transport in the patient-specific three-dimensional head model in response to application of an electric potential and / or current via at least one simulated anode electrode and at least one simulated cathode electrode positioned at selected locations and in electrical communication with the CNS / CSF system to generate EO information.

[0128] In one example, a patient-specific three-dimensional head model is developed based on the patient's image scan using a smoothed voxel approach. First, the patient's image scan is segmented into voxels representing the CSN / CSF system, for example using the expectation maximization (EM) algorithm (Dempster et al., 1977). Next, the voxels are converted into a mesh using various smoothing algorithms (e.g., the algorithm developed by Boyd and Müller (2006)) and material properties assigned to different parts of the CSN / CSF system, thereby forming a patient-specific three-dimensional finite element head model.

[0129] 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 (Methodology). 1977 Sep;39(1):1-22, and Boyd SK, Müller R, “Smooth surface meshing for automated finite element model generation from 3D image data”, Journal of Biomechanics 2006 Jan 1;39(7):1287-95.

[0130] In one embodiment, the selected set of electrode positions includes positions for at least three anode electrodes in an orientation posterior to the area to be aspirated, as viewed from the area to receive the fluid (eg, the superior sagittal sinus).

[0131] In one embodiment, the selected set of electrode positions includes positions for at least two anode electrodes in an orientation posterior to the region to be aspirated, as viewed from the region to receive the fluid (eg, the superior sagittal sinus).

[0132] In one embodiment, the selected set of electrode positions includes a position for at least one anode electrode in an orientation that is located behind the zone from which the fluid is to be withdrawn, as viewed from the zone from which the fluid is to be received.

[0133] In one embodiment, the CNS / CSF system has edema, and the method includes: selecting a fluid source location as an area that includes edema and is targeted for fluid withdrawal; the patient-specific three-dimensional head model simulating fluid transport in a direction away from the edema; and controlling fluid transport and application of electrical potential and / or current to the electrodes to control fluid transport away from the edema.

[0134] In one embodiment, the CNS / CSF system includes a colloidal lymph flow, and the method includes: selecting a fluid source location as an area that includes the colloidal lymph flow and is targeted as an area from which fluid is withdrawn or as an area from which fluid is regulated; simulating regulation / modification of the colloidal lymph flow using the patient-specific three-dimensional head model; and controlling fluid delivery and application of electrical potential and / or current to the electrodes to control the regulation of the colloidal lymph flow.

[0135] In one embodiment, the CNS / CSF system includes a brain having edema, and the method includes controlling fluid delivery to drive at least one fluid away from the edema toward the lateral ventricles and / or toward the superior sagittal sinus.

[0136] In one embodiment, the patient-specific three-dimensional head model includes a 3D model of the CNS / CSF system.

[0137] In one embodiment, the patient-specific three-dimensional head model includes information about the fiber structure within the CNS / CSF system.

[0138] In one embodiment, the patient-specific three-dimensional head model includes information about damaged neural tissue and healthy neural tissue.

[0139] In one embodiment, the patient-specific three-dimensional head model includes a 3D model of the brain and / or cerebrospinal fluid and / or scalp and / or cerebral ventricles and / or skull.

[0140] In one embodiment, the method further comprises placing a helmet-like device comprising a mechanically connected body and at least four spaced-apart electrodes in electrical communication with the CNS / CSF system to be treated. The electrodes are typically positioned so as to be in electrical communication with the CNS / CSF system when the patient wears the helmet-like device. In one example, three electrodes are designated as anode electrodes and one electrode is designated as cathode electrode.

[0141] In one embodiment, the method further comprises placing a device (e.g., a helmet-like device) comprising a mechanically connected body and at least two spaced-apart electrodes in electrical communication with the CNS / CSF system to be treated. The electrodes are typically placed in electrical communication with the CNS / CSF system when the patient wears the helmet-like device. The device can be, for example, a mesh, a cover, or a helmet configured to be attached to the head of the individual to be treated, thereby placing the electrodes in electrical communication with the CNS / CSF system to be treated at predetermined locations on the patient's head.

[0142] Figure 9A control unit 910 according to one or more embodiments of the present disclosure is shown. The control unit 910 may be in the form of, for example, an electronic control unit, a server, an onboard computer, a stationary computing device, a laptop computer, a tablet computer, a handheld computer, a wrist-worn computer, a smart watch, a smart phone, or a smart TV. The control unit 910 may include a processing circuit system 912 communicatively coupled to a transceiver 904, which is configured to perform wired or wireless communications. The control unit 910 may also include at least one optional antenna (not shown). The antenna may be coupled to the transceiver 904 and configured to transmit and / or emit and / or receive wired or wireless signals in a communication network (such as WiFi, Bluetooth, 3G, 4G, 5G, etc.). In one example, the processing circuit system 912 may be any one of a selected processing circuit system and / or a central processing unit and / or a processor module and / or a plurality of processors configured to cooperate with each other. In addition, the control unit 910 may also include a memory 915. Memory 915 may include, for example, selected hard RAM, a magnetic disk drive, a floppy disk drive, a flash drive, or other removable or fixed media drive, or any other suitable memory known in the art. Memory 915 may contain instructions executable by the processing circuitry to perform any of the steps or methods described herein. Processing circuitry 912 may optionally be communicatively coupled to a selected one of transceiver 904, memory 915, and / or any electrodes. Control unit 910 may be configured to send / receive control signals directly to / from any of the above-mentioned units or external nodes, or to send / receive control signals via a wired and / or wireless communication network.

[0143] Wired / wireless transceiver 904 and / or wired / wireless communication network adapter may be configured to send and / or receive data values ​​or parameters as signals to and from processing circuitry 912 , to and from other external nodes.

[0144] In an embodiment, transceiver 904 communicates with external nodes directly or via a wireless communication network.

[0145] In one or more embodiments, the control unit 910 may also include an input device 917 configured to receive input or indications from a user and to send user input signals indicative of the user input or indications to the processing circuitry 912 .

[0146] In one or more embodiments, the control unit 910 may also include a display 918, which is configured to receive a display signal indicating a rendered object (such as, text or a graphical user input object) from the processing circuit system 912 and display the received signal as an object, such as a text or a graphical user input object.

[0147] In one embodiment, the display 918 is integrated with the user input device 917 and is configured to receive a display signal indicating a presented object (such as a text or graphical user input object) from the processing circuit system 912 and display the received signal as an object (such as a text or graphical user input object), and / or is configured to receive input or indication from a user and send a user input signal indicating the user input or indication to the processing circuit system 912.

[0148] In another embodiment, the control unit 910 may also include and / or be coupled to one or more additional sensors (not shown in the figure, such as a temperature sensor for measuring the temperature of the surrounding air) that are configured to receive and / or obtain and / or measure physical properties related to the location and / or patient and / or device.

[0149] In one or more embodiments, the processing circuitry 912 is also communicatively coupled to an input device 917 and / or a display 918 and / or additional sensors and / or any of the units described herein.

[0150] In an embodiment, the communication network communicates using a wired or wireless communication technology, which may include at least one of the following: local area network (LAN), metropolitan area network (MAN), global system for mobile networks (GSM), enhanced data GSM environment (EDGE), global system for mobile telecommunications, long term evolution, high speed downlink packet access (HSDPA), wideband code division multiple access (W-CDMA), code division multiple access (CDMA), time division multiple access (TDMA), Wi-Fi, Voice over Internet Protocol (VoIP), LTE-Advanced, IEEE 802.16m, WirelessMAN-Advanced, Evolved High-Speed ​​Packet Access (HSPA+), 3GPP Long Term Evolution (LTE), Mobile WiMAX (IEEE 802.16e), Ultra Mobile Broadband (UMB) (formerly known as Evolution-Data Optimized (EV-DO) Release C), Fast Low-Latency Access with Seamless Handover Orthogonal Frequency Division Multiplexing (Flash OFDM), High-Capacity Space Division Multiple Access and Mobile Broadband Wireless Access (MBWA) (IEEE 802.20) systems, High Performance Radio Metropolitan Area Networks (HIPERMAN), Beam Division Multiple Access (BDMA), Worldwide Interoperability for Microwave Access (Wi-MAX), and ultrasonic communications, but are not limited thereto.

[0151] Furthermore, the skilled person realizes that the control unit 910 may comprise the necessary communication capabilities, e.g. in the form of functions, means, units, elements, etc. for performing the solution of the present invention. Examples of other such means, units, elements and functions are: 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, receiver units, transmitter units, DSPs, MSDs, TCM encoders, TCM decoders, power supply units, feeders, communication interfaces, communication protocols, etc., which may be suitably arranged together to perform the solution of the present invention.

[0152] In particular, the processing circuitry and / or processing components of the present disclosure may include one or more examples of the following: a processing circuitry that can interpret and execute instructions, a processor module, and multiple processors configured to cooperate with each other, a central processing unit (CPU), a processing unit, a processing circuit, a processor, an application specific integrated circuit (ASIC), a microprocessor, a field programmable gate array (FPGA), or other processing logic. Thus, the expression "processing circuitry" and / or "processing component" may refer to a processing circuitry that includes multiple processing circuits, such as any, some, or all of the above. The processing component may also perform data processing functions of inputting, outputting, and processing data, including data buffering and device control functions, such as user interface control, etc.

[0153] Finally, it should be understood that the present invention is not limited to the embodiments described above, but also relates to and includes all embodiments within the scope of the accompanying independent claims.

[0154] List implementation plans

[0155] Embodiment 1. A method of inducing controlled fluid transport in the central nervous system (CNS) and / or in the cerebrospinal fluid (CSF) system by electroosmosis, the method comprising:

[0156] a) receiving information regarding electrode positions and / or electrode potentials and / or electrode currents selected to achieve controlled fluid delivery in the CNS / CSF system, wherein the information is generated by computer simulation of induced fluid delivery in a computer model of the CNS / CSF system, the computer model being generated based on a set of image scans of the CNS / CSF system, and the simulation being performed by simulating in the computer model the fluid delivery response resulting from application of potentials and / or currents via at least one simulated anode and at least one simulated cathode placed in electrical communication with the CNS / CSF system,

[0157] b) placing at least two electrodes in electrical communication with the CNS / CSF system, and

[0158] c) controlling, using a control unit, application of an electrical potential and / or current to the electrodes based on information received from the computer simulation to induce controlled fluid delivery in the CNS / CSF system.

[0159] Embodiment 2. The method of claim 1 , wherein the method comprises selecting a region of the CNS / CSF system from which fluid is to be withdrawn and selecting a region of the CNS / CSF system from which fluid is to be received, and wherein step b) comprises:

[0160] b1) placing at least one cathode in electrical communication with the CNS / CSF system in an orientation behind the zone to receive fluid as viewed from the zone to be withdrawn, and

[0161] b2) placing at least one anode in electrical communication with the CNS / CSF system in a spaced-apart orientation behind the zone from which fluid is to be withdrawn, as viewed from the zone from which fluid is to be received.

[0162] Embodiment 3. The method according to claim 1 or 2, characterized in that step c) comprises:

[0163] c1) using a control unit to control the application of potential and / or current to at least one cathode and at least one anode to focus fluid transport from the zone selected to be drawn from the fluid towards the zone selected to be received by the fluid.

[0164] Embodiment 4. The method according to claim 1 is characterized in that the set of image scans is a set of CT image scans.

[0165] Embodiment 5. The method of claim 1, further comprising:

[0166] a1) receiving in a computer memory at least one set of image scans of said CNS / CSF system,

[0167] a2) generating a computer model of the CNS / CSF system based on the received set of image scans, and

[0168] a3) using a computer to simulate fluid transport in a computer model of the CNS / CSF system in response to application of an electric potential and / or current via at least one simulated anode and at least one simulated cathode placed in electrical communication with the CNS / CSF system.

[0169] Embodiment 6. The method of claim 5, comprising placing at least three anodes in an orientation behind the zone from which the fluid will be withdrawn, as viewed from the zone from which the fluid will be received.

[0170] Embodiment 7. The method of any one of the preceding claims, wherein the CNS / CSF system is edematous and the method comprises

[0171] - selecting the edema as the area from which the fluid will be withdrawn,

[0172] - simulating fluid transport in a direction away from the edema, and

[0173] - controlling said fluid delivery and said applying of electrical potential and / or current to said electrodes to control fluid delivery away from said edema.

[0174] Embodiment 8. The method of claim 7, wherein the CNS / CSF system includes a brain having edema, and wherein the method comprises controlling the fluid delivery to drive at least one fluid away from the edema toward the lateral ventricles and / or toward the superior sagittal sinus.

[0175] Embodiment 9. The method of any preceding claim, wherein the computer model comprises a 3D model of the CNS / CSF system.

[0176] Embodiment 10. The method of any preceding claim, wherein the computer model of the CNS / CSF system includes information about fiber structure within the CNS / CSF system.

[0177] Embodiment 11. The method of any of the preceding claims, wherein the computer model includes information about damaged neural tissue and healthy neural tissue.

[0178] Embodiment 12. The method of any preceding claim, wherein the computer model comprises a 3D model of the brain, cerebral fluid, cerebral ventricles, skull, and scalp.

[0179] Embodiment 13. A method according to any of the preceding claims, characterized in that the method comprises placing a device comprising a mechanically connected body and at least four spaced apart electrodes in electrical communication with the CNS / CSF system to be treated.

[0180] Embodiment 14. The method of claim 13, wherein the device is a net, a mask, or a helmet configured to fit over the head of the individual to be treated.

[0181] Embodiment 15. A device for inducing controlled fluid transport in a central nervous system (CNS) and / or in a cerebrospinal fluid (CSF) system by electroosmosis, the device comprising a mechanical connection body, at least two electrodes spaced apart and arranged on the mechanical connection body, and electrical wiring, wherein the mechanical connection body 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 according to step b) of the method as claimed in claim 1, and the wiring is configured to allow the electrodes to be controlled by a control unit according to step c) of the method as claimed in claim 1.

[0182] Embodiment 16. The device according to embodiment 15 is characterized in that the device includes at least three and / or four and / or five electrodes arranged at intervals on the mechanical connection body.

[0183] Embodiment 17. The device of any preceding embodiment, wherein the device comprises at least one set of electrodes arranged in a row along the mechanical connection body.

[0184] Embodiment 18. A device according to any preceding embodiment, characterized in that the device includes a set of electrodes arranged along the perimeter of the mechanical connection body.

[0185] Embodiment 19. A device according to any of the preceding embodiments, characterized in that the mechanical connection body is a mesh, a cover or a helmet, which is configured to be fitted onto the head of an individual to be treated and to establish electrical communication between the electrodes of the device and the CNS / CSF system of the individual.

[0186] Embodiment 20. The device of any preceding embodiment, wherein at least one electrode is arranged to be placed on top of the individual's head.

[0187] Embodiment 21. The device of any preceding embodiment, wherein the wiring is configured to permit separate control of the potential and / or current applied to at least two sets of electrodes in the device.

[0188] Embodiment 22. The device of any preceding embodiment, wherein the device is configured to permit individual control of the potential and / or current applied to each individual electrode.

[0189] Embodiment 23. A computer program module, characterized in that the computer program module is configured to induce a computer to execute step c) of the method according to claim 1.

[0190] Embodiment 24. The computer program module according to any of the preceding embodiments, characterized in that the computer program module is configured to induce a computer to perform steps a1) to a4) of the method according to claim 5.

[0191] Embodiment 25. A computer program module, characterized in that the computer program is configured to induce a computer to perform any method step of the method described herein.

[0192] Embodiment 26. A system for inducing controlled fluid transport in the central nervous system (CNS) and / or in the cerebrospinal fluid (CSF) system by electroosmosis, the system comprising:

[0193] - a device comprising at least two electrodes adapted to be placed in electrical communication with the central nervous system (CNS) and / or cerebrospinal fluid (CSF) system,

[0194] - a control unit configured to control the application of electric potentials and / or currents to the electrodes in the device, and

[0195] - A computer program module configured to perform any of the method steps described herein.

[0196] Embodiment 27. The system of embodiment 26, further comprising:

[0197] - A computer program module configured to perform any of the method steps described herein at specific steps a1) to a3).

[0198] Embodiment 28. A system according to any of the preceding embodiments, characterized in that the device is a helmet-like device.

[0199] Embodiment 29. A system according to any of the preceding embodiments, characterized in that the control unit includes one or more potential and / or current generators, which are configured to supply potential and / or current to the electrodes of the device according to the method described herein.

Claims

1. A system for inducing controlled fluid transport in the central nervous system (CNS) and / or in the cerebrospinal fluid (CSF) system of a patient by electroosmotic EO via two or more electrodes (221, 222, 223, 224, 225, 226, 227, 231) placed at selected locations on the patient's head, the system comprising: a device comprising at least two electrodes adapted to be placed in electrical communication with a central nervous system (CNS) and / or a cerebrospinal fluid (CSF) system, a control unit configured to control the application of electric potential and / or current to the electrodes in the device, and A computer program module configured to perform the following steps: receiving EO information indicating at least a fluid delivery response resulting from applying specific electrical potentials and / or currents at specific electrode locations on the patient's head based on a patient-specific three-dimensional head model, receiving a fluid source location within the patient's head, selecting a set of electrode positions using the EO information and the fluid source position, placing the two or more electrodes (221, 222, 223, 224, 225, 226, 227, 231) in electrical communication with the CNS / CSF system, each electrode being placed at one of the selected set of electrode locations, and Controlling 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 the set of electrode locations selected based on the EO information to induce controlled fluid delivery in the CNS / CSF system.

2. The system according to claim 1, wherein: The EO information includes information on electrode positions and / or electrode potentials and / or electrode currents selected to achieve controlled fluid delivery in the CNS / CSF system.

3. The system according to claim 1, wherein: The EO information is received by a computer program module by generating the EO information by computer simulation of induced fluid delivery in the patient-specific three-dimensional head model of the CNS / CSF system, wherein the patient-specific three-dimensional head model is generated based on a set of image scans (310, 410, 510) of the CNS / CSF system, and wherein the simulation is performed by simulating in the patient-specific three-dimensional head model the fluid delivery response resulting from application of an electric potential and / or current via at least one simulated anode electrode and at least one simulated cathode electrode positioned in electrical communication with the CNS / CSF system.

4. The system according to claim 1, wherein: The EO information is received by retrieving predetermined EO information from memory (915).

5. The system according to claim 1, wherein: The EO information is received by receiving user input from an input device (917).

6. The system according to claim 1, wherein: The system further comprises: selecting the region of the CNS / CSF system from which fluid is to be withdrawn, and receiving a fluid target site as the location of a selected area of ​​the CNS / CSF system that will receive the fluid, and Electrode placement also includes: placing at least one cathode electrode (221, 222, 223, 231) in electrical communication with the CNS / CSF system in an orientation behind the zone to receive fluid as viewed from the zone from which fluid is to be withdrawn, and At least one anode electrode (221, 222, 223, 224, 225, 226, 227) is placed in electrical communication with the CNS / CSF system in a spaced-apart orientation behind the zone from which fluid is to be withdrawn, as viewed from the zone from which fluid is to be received.

7. The system according to claim 1, wherein: The control also includes: The application of the potential and / or current to the at least one cathode electrode and the at least one anode electrode is controlled using a control unit to focus fluid transport from the zone selected to be drawn from the fluid towards the zone selected to receive the fluid.

8. The system according to claim 3, wherein: The set of image scans is a set of CT image scans (310, 410, 510) and / or a set of multimodal medical image scans, such as magnetic resonance imaging (MRI) image scans and / or ultrasound image scans and / or positron emission tomography (PET) image scans.

9. The system according to claim 1, wherein: The system further comprises: receiving in a computer memory (915) at least one set of image scans of the CNS / CSF system, generating the patient-specific three-dimensional head model of the CNS / CSF system based on the received set of image scans, and The EO information is generated using a computer to simulate fluid delivery in the patient-specific three-dimensional head model in response to application of an electric potential and / or current via at least one simulated anode electrode and at least one simulated cathode electrode placed at selected locations and in electrical communication with the CNS / CSF system.

10. The system according to claim 1, wherein: The selected set of electrode positions includes positions of at least three anode electrodes (221, 222, 223, 224, 225, 226) that are positioned behind the zone to be pumped out as viewed from the zone receiving the fluid.

11. The system according to claim 1, wherein: The selected set of electrode positions includes the position of at least one anode electrode (221, 222, 223, 224, 225, 226, 227) located behind the zone to be withdrawn as viewed from the zone receiving the fluid.

12. The system according to claim 1, wherein: The CNS / CSF system suffers from edema (250), and the system comprises The fluid source location is selected to include the edema (250) and is defined as the area from which the fluid is to be withdrawn, simulating fluid transport in a direction away from the edema (250) using the patient-specific three-dimensional head model, and The fluid delivery and the application of the electrical potential and / or current to the electrodes are controlled to control fluid delivery away from the edema (250).

13. The system according to claim 1, wherein: The CNS / CSF system has a colloidal lymphatic flow and includes selecting the fluid source location to be an area that includes the colloidal lymphatic flow and is targeted as an area from which fluid is to be withdrawn or targeted as an area for regulating the fluid, using the patient-specific three-dimensional head model to simulate modulation / modification of the colloidal lymphatic flow, and The fluid delivery and the application of electrical potential and / or current to the electrodes are controlled to control the regulation of the colloidal lymph flow.

14. The system according to claim 1, wherein: The CNS / CSF system includes a brain having edema (250), and the system includes controlling the fluid delivery to drive at least one fluid away from the edema (250) toward the lateral ventricles and / or toward the superior sagittal sinus.

15. The system according to claim 3, wherein: The patient-specific three-dimensional head model includes a 3D model of the CNS / CSF system.

16. The system according to claim 3, wherein: The patient-specific three-dimensional head model includes information about the fiber structure within the CNS / CSF system.

17. The system according to claim 3, wherein: The patient-specific three-dimensional head model includes information about damaged neural tissue and healthy neural tissue.

18. The system according to claim 3, wherein: The patient-specific three-dimensional head model includes a 3D model of the brain and / or cerebrospinal fluid and / or scalp and / or cerebral ventricles and / or skull.

19. The system according to claim 1, wherein: The system further comprises: A helmet-like device comprising a mechanically connected body and at least four spaced apart electrodes (221, 222, 223, 224, 225, 226, 227, 231) is placed in electrical communication with the CNS / CSF system to be treated.

20. A system according to any one of the preceding claims, characterised in that The system includes placing a device (210) comprising a mechanically connected body and at least two spaced apart electrodes (221, 222, 223, 224, 225, 226, 227, 231) in electrical communication with the CNS / CSF system to be treated.

21. The system according to claim 20, wherein: The device (210) is a net, cover or helmet configured to fit over the head of an individual to be treated.

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