A device that enables the opening and control of the blood-brain barrier.

Abstract

The invention is a device with a head body (1) that opens and controls the blood-brain barrier and is intended for use in therapeutic applications involving electric fields, particularly in serious diseases such as brain tumors or more common diseases such as meningitis. It can be used for any drug that needs to cross the blood-brain barrier, is suitable for any disease, has no effect on other organs due to its local application, and has the advantage of not causing an increase in temperature in the applied area.

Description

1 TARIFF A device that enables the opening and control of the blood-brain barrier. Technical Area The invention is a head-mounted device that opens and controls the blood-brain barrier using electric fields. Treatment uses related to this are particularly common in serious illnesses such as brain tumors and in more frequent conditions like meningitis. It is a device intended for use in diseases encountered and in any condition where the blood-brain barrier needs to be crossed. It can be used for medicinal purposes, it can be used in every disease, and due to its local application, it does not reach other organs. It relates to a device that offers the advantage of having no effect whatsoever. State of the Art The blood-brain barrier (BBB) ​​prevents toxic compounds and pathogens from passing from the blood to the brain, protecting against nutrient imbalances. These elements are transmitted to the brain between the central nervous system (CNS) and the peripheral nervous system. It describes a highly selective and dynamic endothelial barrier that is regulated. The blood-brain barrier, It ensures brain homeostasis for the healthy functioning of synaptic and neuronal functions. Blood 15 Brain barrier functions are performed by neurovascular proteins such as tight junctions, astrocytes, and pericytes. It is carried out through the elements of the unit. Nutrition, neuronal activity and aging, air pollution, heavy Environmental factors such as exposure to metals, smoking, alcohol, stress, and exercise can affect the blood-brain barrier. It plays a role in its modulation. Neuroinflammation develops following damage that occurs in the brain. It is a coordinated response. The effect on blood-brain barrier permeability in response to altered brain homeostasis 20 A series of inflammatory mediators are released. Various antioxidant components, nutraceuticals, and vitamins are also involved. Dietary factors influence neuroinflammation and play a role in blood-brain barrier permeability. It plays a role. However, the medications that will be used in the developing disorders also cross the blood-brain barrier. It will be ineffective if its permeability is prevented. Some pathogen-sensitive antibiotics that should be given to some meningitis patients in intensive care are 25. by inserting a drainage catheter into the ventricle of patients or by directly draining cerebrospinal fluid from the lumbar region. It becomes necessary to give. These procedures require a surgical process, and are quite... They may encounter risky complications (infection, bleeding, herniation, etc.). Also, leukemia. In diseases like lymphoma where the brain is affected, the same method has to be used. This Due to conditions such as thrombocytopenia that we observe in the course of the disease in this patient group, these procedures are 30 Sometimes this may not happen. Also, in these intensive care patients who are taking multiple medications... 2 The need to use sedative drugs and high doses of medication is both costly and time-consuming for patients. Prolonged stays in intensive care units can lead to problematic situations. Several methods, such as focused ultrasound, osmotic disruption, and drug delivery vehicles, can cross the blood-brain barrier. Methods of delivering drugs via electroconvulsive pathways are being widely researched. Electrochemotherapy is a field of tumor treatment. (TTFields) includes various 5 deep brain stimulation (DBS) and irreversible electroporation. Electric field applications are used in the treatment of certain central nervous system diseases, such as tumors. These methods, each with its own advantages and disadvantages, are not always easy to implement. There are many factors involved, such as implementation difficulties, the need for specific personnel, and high costs. This is the issue. Despite advanced technologies, achieving complete control over the blood-brain barrier is not yet possible. This does not seem possible. There are ongoing debates regarding both clinical use and efficacy in these applications. 10 This restricts its use. The blood-brain barrier (BBB) ​​influences the characteristics of the microvascular structure of the central nervous system (CNS), among other things. It is a term used to describe the distinction between vascular structures in organs and those in the central nervous system (CNS). It tightly regulates the movements of molecules, ions, and cells. However, many clinical diseases In this situation, this barrier may be disrupted. This disruption allows certain substances or drugs circulating in the blood to enter the bloodstream. It can cross the blood-brain barrier, leading to a high concentration in the brain. In these cases... The dosage of the medication may need to be adjusted. This is because high doses of medication that reach the brain can cause side effects and prolonged effects. This can lead to situations such as these. In such cases, reducing the dose of the medication can decrease its effectiveness. It reduces the likelihood of side effects without changing the dose. In other words, the effect will be higher at a lower dose, so with a reduced amount of medication. The cost can be reduced. Another clinical situation is that this brain-protecting mechanism is compromised in some disease states. It is the blockage of the passage of drugs that need to reach the brain. This also occurs in the blood-brain barrier. By controlling the opening, the dosage of many medications used can be reduced, thus opening the blood-brain barrier. It can make it possible for drugs that cannot pass through to do so. Especially in some cases, such as brain tumors, blood flow to the brain. Treatments aimed at crossing the meningitis barrier have been attempted. However, some infectious diseases, such as meningitis, In this case, some antibiotics that cannot cross the blood-brain barrier are administered directly to the spinal cord. 25 It may be necessary. This situation requires both experience and poses an additional risk of infection for the patient. Blood brain By enabling controlled opening of the barrier, these drugs can easily cross the blood-brain barrier. With intravenous administration, sufficient effect can be seen in the brain. Thus, invasive administration into the ventricle or spinal space is not possible. The medication can be administered without any procedure. The US2021016084A1 method for altering the permeability of the blood-brain barrier, as seen in the previous technique, is 30. It is explained that a blood-brain barrier or a controlled application of pulsed electric fields can create a barrier. a method aimed at increasing the permeability of a selected blood-cerebrospinal fluid barrier, specifically the brain barrier. It is a system and a method. It involves applying pulsed electric fields (PEFs) to the targeted region. through a brain barrier (BB) to a targeted region of the central nervous system (CNS) 3 It provides a method to increase its permeability. BB, optionally, is a blood-brain barrier (BBB). or a blood-brain and blood-cerebrospinal fluid barrier (BCSFB). A BCSFB is optionally a The choroid plexus is a BCSFB or meningeal barrier. The CNS region is optionally one of the following: It is a region that includes one or more of the following: a brain, a brainstem, a spinal cord, and a choroid plexus. In this way, in accordance with a regulation of the statement, the electric field 5 is used to produce a BB-destructive effect. Control signals to be sent from the computer device to the signal generator for the source are optional. It can be generated by the processor executing a series of instructions stored in memory. Thus, on the barriers The effect can be achieved. A headpiece, a body structured from glass in the headpiece's field of vision, and opposite sides. It lacks the criterion of providing a suitable electric field with the plates. The document numbered US6594156B1, seen in the current technique, describes circuit 10 during radiation sterilization. The device and method for protection are described. High voltage is used to obtain high radiation. It is used. However, the invention described in this patent relates to safety in a sterilization device. The headpiece consists of a glass-structured body within the headpiece's field of vision and appropriate electrical wiring via opposing plates. It lacks the criterion of providing space. In the previous technique, the document seen with CN113908432A showed a blood-brain barrier permeability of 15. The use of alternating electric fields to increase high-energy radiation is described. A support substrate and preservative for protecting sensitive components during sterilization. It is a circuit protection device containing an enclosure. The protective enclosure protects the sensitive components inside the protective housing. The components are hermetically bonded to the support substrate to isolate them. Preferably protective. The housing, the high energy used in high-energy sterilization, high-energy sterilization 20 It prevents damage to sensitive components due to a predetermined exposure level. A hood consists of a body structured in glass and opposing plates that fit within the hood's field of vision. It lacks the criterion of providing an electric field. According to document number WO2009126384A1, which refers to the known state of the art, from the connected environmental device. It includes an electrically insulated ambulance medical device. First and second circuit, a pair of first and second 25 It is electrically isolated using an isolation transceiver. Here, the first isolation transceiver is... The first pair transmits a control signal, and the second isolation transceiver pair consists of at least one communicating giant magneto- They are refractive index (GMR) transceivers. A headset consists of a glass-structured body within the headset's field of vision, and... It lacks the criterion of providing a suitable electric field with opposing plates. The use of magnetic, electrical, and electromagnetic energy in medical electrotherapy is quite old. ISM 30 Many frequency ranges within the (industrial, scientific and medical) band have been approved by the FDA. Medically, these devices have been used both for imaging and in routine treatment in some clinics. However, magnetic, electromagnetic field or wave energy depends on the operating frequency of the antenna, coil, capacitive 4 Controlled energy transfer to the desired area of ​​the body by the physician using accessories such as applicators. This can be done. All these application methods are used to focus energy on the desired area. There are many concerns regarding electrical efficiency due to the increase in temperature in the application area. It contains. The 5 mentioned above are planned to gain control of the blood-brain barrier, which has remained a mystery for years. Changes to existing treatments or the device(s) could harm the patient. These are some of the many treatment methods that are both dangerous and costly. In this case, both treatment The goal is to create a multifunctional device that is both easy to use and cost-effective. The technology... In its known form, it provides non-invasive, inexpensive treatments that allow for a reduction in drug dosages. Importantly, it is necessary to conduct research that contributes to science and plays a key role in many studies. 10 Purpose of the Invention The aim of the invention is to deliver smaller amounts of medication to the brain by enabling controlled crossing of the blood-brain barrier. A device that allows passage, thus reducing potential side effects, and is both inexpensive and non-invasive. It is obtained. 15 The aim of the invention is to use the electric field in serious diseases such as brain tumors, as well as meningitis. The aim is to provide a device for use in more common diseases such as these. The aim of the invention is to create a device that can be used for any drug that needs to cross the blood-brain barrier and for any disease. Its use is made possible by local application, therefore it has no effect on other organs. It is the provision of an advantageous device that does not cause problems. 20 The aim of the invention is to bypass the blood-brain barrier using an electric field without damaging the brain. changes that allow the administered drugs to reach the brain, especially the blood-brain barrier. non-invasive passage of drugs that cannot cross the blood-brain barrier and anesthetics that act by crossing the blood-brain barrier. This device allows medications, such as those used in drugs, to be effective by using lower doses through this method. It is done. 25 The purpose of the invention is to create a device that, when used in the form of a cap, crosses the blood-brain barrier when administered in the appropriate dose and for the appropriate duration. The goal is to obtain a device that has an effect. The invention aims to provide ease of use by being able to be attached to the bedside, remotely. The result is a device that provides comfort for the user thanks to its remote control operation. The aim of the invention is to create a blood-brain pathway using this device, which is easy to apply to the patient and provides a non-invasive method. drugs that cannot cross the blood-brain barrier can be used to reduce the dosage of drugs that act by crossing the blood-brain barrier. However, treatments for diseases such as meningitis, encephalitis, brain tumors, or lymphoma cannot be administered directly into the cerebrospinal fluid (CSF). an electrical procedure that allows for intravenous administration instead of invasive application. The goal is to obtain a device in the form of a headset that uses space. The invention's purpose is to use only an electric field, without causing a temperature increase in the area where it is applied. It works with very high efficiency, and its parallel plates in the applicator allow blood to reach the brain in the head region. A blood-brain barrier that has the ability to focus blood without affecting another part of the body. 5 The goal is to obtain a barrier opening device. The purpose of the invention is to create a semicircular headgear, preferably made of PVC, that will enclose the human head. is the creation of. The aim of the invention is to overcome claustrophobia encountered in magnetic resonance imaging devices by moving upwards. A glass body structure that does not obstruct the patient's field of vision and allows them to see their surroundings when looking correctly. 10 is the creation of. The purpose of the invention is to create a glass body with a center and opaque ends, preferably made of PVC, at both ends. An electric field is created by two CrNi plates positioned vertically and parallel to each other in a way that is not visible from the outside. is to ensure. The purpose of the invention is to have one of the plates fixed to the operational grounding and the other connected to the electrical 15 Configure it so that it is connected to the output of the field generator with a high-voltage cable. is to ensure. The invention is a device that enables the crossing of the blood-brain barrier, consisting of a semicircular headpiece and a field of view. a body structured to be glass, with PVC body ends embedded at both ends of the hood body plates that provide the electric field, control unit that allows adjustment of the electric field frequency value, 20 A Bluetooth remote control, control unit, and head are connected to each other for remote control purposes. It includes connecting cables that connect the devices and provide power transmission. Explanation of Invention Methods Figure – 1 View of an Electric Field Cap that Opens the Blood-Brain Barrier 25 Figure 2 - Top View of the Electric Field Headset that Opens the Blood-Brain Barrier Figure 3 - General view of an electric field device that opens the blood-brain barrier. Figure 4 - View of the Control Unit of the Electric Field Device that Opens the Blood-Brain Barrier Figure 5 - Pulsed Wave Graph of Trigger Voltage Applied from the Control Unit to the Plates 6 Part Reference Numbers: 1. Header Body 1.1. Upper Part 1.2. Left Part 1.3. Right Part 5 1.4. License Plate 2. Connection Cable 3. Control Unit 3.1. Screen 3.2. Adjustment Knobs 10 3.3. Receipt 4. Remote control 4.1. Screen 4.2. Button 5. Patient Bedside 15 Detailed Description of the Invention The device that opens or controls the blood-brain barrier, shown in a top view in Figure 2, A single, integrated head body (1) is positioned non-invasively on the patient's head (5), observing the patient's vision The part of the head body (1) which is transparent in the area, the upper part (1.1) and the body (1) embedded at the end 20 It consists of right and left parts (1.2, 1.3) containing electric field plates (1.4). Transparent top part (1.1) preferably made of glass and preferably the right and left parts (1.2, 1.3) made of PVC material It has been made. It contains a control unit (3) that provides an electric field to the plates (1.4). Head body (1) is connected to the control unit (3) via the connection cable (2). However, the control The unit (3) converts the necessary power for the electric field through a connecting cable (2) and a plug (3.3) 25 It has an adjustment on the control unit (3) that allows the electric field frequency adjustment to be made. It includes buttons (3.2) and a screen (3.1) that allows the user to see the values. The control unit contains a remote control module which is not shown in the figures (3). Wireless The communication module was preferably used via Bluetooth. The patient / user should be in a supine position. Since controlling the device via the power source would be difficult, the device can be controlled by communicating with a wireless communication module. 7 It includes a remote control (4) that provides control. The remote control (4) is preferably connected to a wireless communication module. It connects via Bluetooth. The remote control (4) allows adjustment of the electric field frequency. buttons (4.2) and a screen (4.1) that allows viewing frequency values ​​and other parameters. The device in question has right and left parts (1.2, 1.3) preferably for the human head (5) region. It is an applicator made of PVC material. The right and left parts (1, 2, 5) are also made of PVC material. 1.3) The electric field vector of the plates embedded in it is directed towards the target tissue in the head (5) region It is used for guidance. The middle part, i.e. the upper part (1.1), of the device head (1) is for the human. It is designed as a transparent partition, preferably made of glass, to combat claustrophobia. The basic connection of the device is powered by the control unit (3) (magnitude of the electric field vector) value, application time, device (set by the adjustment buttons (3.2) on the screen (3.1) 10 The effective value of the high voltage pulses applied to the plates (1.4) is shown. Human head (5) The homogeneous electrical distance between the plates (1.4) is as long as this distance is below the head body (1). It is exposed to the field. The device in question does not cause a temperature increase in the area where it is applied, because it uses only an electric field. With its highly efficient operation, the patient's head (5) with the parallel plates (1.4) in its applicator 15 focusing in a region that will affect the blood-brain barrier and not affect any other part of the body. Its capability surpasses all previous forms of application. The subject of the invention is law. The brain barrier opening device preferably has left and right parts made of PVC (1.2, 1.3) and is used on the patient It has a semicircular structure that will include the head (5) area. The head body (1) of the device is preferably deep If the width is 100 cm and the height is 50 cm, then a 20 cm diameter is ideal for the average human head size. It forms a structure. The given values ​​may vary depending on the application or the preferred alternative of the invention. It may vary depending on the applications. It does not create a limiting effect. The upper part of the device. (1.1) thanks to its transparency, the patient is relieved of claustrophobia encountered in magnetic resonance imaging devices. will be free and preferably positioned in a way that will not obstruct the view of the patient who is looking upwards. It has an upper part (1.1) which is a glass-made central structure. The transparent upper part (1.1) is 25 Immediately afterwards, preferably invisible inside the left and right parts (1.2, 1.3) which are made of PVC. Two 1mm thick CrNi plates (1.4) are fixed in a vertical and parallel manner. The number of pieces and plate thickness (1.4) will vary according to the preferred applications of the invention. It can show. It does not create a limiting effect. Of these plates (1.4), the right part (1.3) While the embedded operational grounding is configured in a fixed manner, the plate 30 embedded in the left part (1.2) (1.4) will be connected to the output of the electric field generator with a high voltage cable. This structure belongs to Technical details are shown in Figure 1 and Figure 3. The patient can be monitored wirelessly using the remote control (4), preferably with Bluetooth communication, shown in Figure 4. how long the application was received and at what intensity the area was exposed to is shown on the screen (4.1) 8 It will be visible. Since the horizontal width of the head body (1) will be around 1 meter, a standard patient It will be easy to mount on the bed. The given value varies according to the preferred applications of the invention. It does not create a limiting effect, as it may show. The control unit (3) receives from the mains. The supply voltage can be increased to a maximum effective value of 38 kV via the step-up transformer inside. It can be extracted. This sine wave voltage is sliced ​​using a dimmer connected in series with the circuit. 5 This sinusoidal application voltage is rectified to half wave using high-voltage diodes connected in series. It is applied to the plates as shown. Since the distance between the plates (1.4) is fixed at 85 cm, the plates (1.4) Electric field pulses with a maximum effective value of 44.7 kV and a frequency of 50 Hz are generated between them. The invention has a title body (1) and when administered in appropriate doses and for appropriate durations, it has an effect on the blood-brain barrier. It is a device that provides ease of use at the bedside and is controlled by a remote control (4). It provides comfort for the user. This device, which is easy to apply to the patient and non-invasive, allows blood to be drawn. Doses of drugs that cross the blood-brain barrier will be reduced, while those that cannot cross the blood-brain barrier will be treated accordingly. Treatment of diseases such as meningitis, encephalitis, brain tumors, or lymphoma involves direct invasive procedures into the cerebrospinal fluid (CSF). Instead of applying it intravenously, it is a device that provides a method for administering it only intravenously. Because these diseases are quite risky and have high mortality rates if left untreated. Same 15 Over time, many treatments may need to be used together during this disease process. Applying fewer medications may be necessary. Another advantage is that polypharmacy helps reduce the side effects that may occur. Known... Application methods are used in focusing energy to the desired area, in electrical efficiency, and in application. It creates a temperature increase in the region. Thanks to the device that is the subject of this invention, the temperature in the applied region can now be increased. There will be no increase, and it will not affect other organs, ensuring safe use. 20 Blood brain used in the treatment of diseases such as meningitis, encephalitis, brain tumors, or lymphoma. The need for direct administration of drugs that cannot cross the cerebrospinal fluid (CSF) into the cerebrospinal fluid (CSF). by eliminating the need for drugs to be administered only intravenously, or by cutting the blood-brain barrier. drugs that cross the blood-brain barrier, allowing for a reduction in the dose of drugs that act by crossing the barrier, or that open the blood-brain barrier. a device using an electric field to control it, non-invasively per patient (5) 25 positioned head body (1), plate (1.4) embedded in the head body (1), It includes a control unit (3) that provides electric field supply and control. In the head (5) area The plate (1.4) enables the direction of the electric field vector toward the target tissue. The supply voltage it receives from the grid is increased to a maximum effective value of 38 kV via the step-up transformer inside. It increases the sine wave by up to 30, then slices the sine wave through a dimmer connected in series with the circuit, thus... The sinusoidal application voltage is rectified to half-wave rectification by high-voltage diodes connected in series. It includes a control unit (3) that transfers data to the plates (1.4). The patient's head is located under the head body (1). (5) Enhancing the permeability of the blood-brain barrier by being exposed to a homogeneous electric field The plate mentioned is (1.4). The head body (1) is semi-circular in shape. Patient 9 The upper part (1.1) which is within the field of view is transparent, allowing the patient to see around. The head body (1) is included. The upper part (1.1) is made of glass material. From the outside The vertically embedded in the left and right parts (1.2, 1.3) of the header body (1) in such a way that it is not visible and contains CrNi plates (1.4) facing parallel to each other. The right and left of the head body (1) Parts (1.2, 1.3) are made of PVC material. Fixed to the operational grounding. the hood body, which provides protection against any electrical leakage hazards by being connected (1) contains the plate (1.4) embedded in the right part (1.3). High voltage to the output of the electric field generator. The left part of the head (1.2) connected by the cable contains an embedded plate (1.4). From the control unit (3) thanks to the change in the incoming supply voltage and the fact that the distance between them is 85 cm, up to 11.7 kV / m Plate (1.4) 10 which generates homogeneous electric field pulses with an effective value of 44.7 kV / m and a frequency of 50 Hz It is made of conductive materials and transmits electric current to the control unit (3) and the head. It has connecting cables (2) that enable its implementation. At the end of the connecting cable (2) It includes a plug (3.3) which connects and allows current to be drawn by inserting both ends into a socket that matches it. From the control unit (3), the duration of application of the electric current to be applied to the patient and the cutting It has adjustment knobs (3.2) that allow the frequency to be adjusted. Control unit (3) 15 the magnitude of the electric field vector, the application time, applied to the plates (1.4) The screen (3.1) allows displaying the effective value of the high voltage pulses. Control It includes a wireless communication module that enables remote control of the unit (3). Wireless communication The module uses Bluetooth in the 2.4 to 2.48 GHz range, which is designed for indoor communications. It is a communication module. The electric field value from the control unit (3) is 20 via the wireless communication module. The remote control (4) enables remote control of the frequency and application time. It is wireless. In this way, the duration of electric field application and the level of electric field exposure of the patient can be measured remotely. The remote control (4) includes the adjustment knob (4.2) and the display (4.1) which allows adjustment. As can be seen from the pulsed wave graph of the voltage applied to the plates shown in Figure 5, successive As seen, there is a 20 ms time difference between the incoming pulses. Thus, the trigger voltage is 25. This waveform is applied to the Gate of the power adapter, supplying the circuit with a 220 V supply voltage. It is sliced. The control unit (3) takes the 220 V sine wave supply from the mains and fires a thyristor. It is applied to the circuit. Since the mains frequency is 50 Hz, the fundamental period is 20 ms. In Figure 5 The observed firing pulses were taken from the chopper circuit. The chopper circuit operates in the range of 0-76 degrees (0 ms- 6 By firing (ms), it cuts off the supply input of the high-voltage transformer, which gives us an output voltage of 10 kV-30 kV. It allows adjustment in the 44 kV range. Half-wave rectified on the plates shown in Figure 1 (1.4) and a chopped supply voltage is applied. Thus, the supply voltage applied to the plates (1.4) By changing the plates (1.4), a homogeneous electric field of 1.7 kV / m –44.7 kV / m is obtained between them. The invention concerns a blood-brain barrier opening and control device that operates electrically and electromagnetically safely. An innovative system that can apply a pulsed electric field with adjustable power and duration to the patient's head (5) region. The device consists of two 1mm thick, 25X25X25 cm CrNi plates (1.4) It contains these plates (1.4) embedded in a semicircular PVC block. It contains. It is structured in such a way that it will not come into contact with the patient. The connection of the plates (1.4) 5 The sockets of the cables (2) shall comply with current medical device standards. (IEC60601 AAMI / NFPA 99 is a specific standard for medical devices and refers to such sensitive devices in section 3 of the IEC 60601.1 standard. description of the requirements for devices to protect the patient or user from the hazards of electric shock. (There is.) The control unit (3) slices the 220 V sine wave supply voltage it receives from the mains and slices the pulses. It creates. In addition, the application time and the frequency of cutting can be adjusted with the adjustment knobs (3.2) on this unit (3). These settings can be configured. If desired, these settings can also be configured wirelessly via the Bluetooth protocol. It will be able to do so. The application time is 1-20 minutes with the adjustment knobs (3.2) on the control unit (3). It can be adjusted periodically. The electric field intensity is between 11.7 kV / m and 44.7 kV / m. It will be adjustable. The device head body (1) or cables (2) will not affect other devices around it. It is configured in such a way that it will not be affected by these devices (IEC 60601-1-2). Which 15 devices Regardless of the working conditions, it will not create conditions such as explosion, flash fire, fire, or smoke. (https: / / www.rigelmedical.com / gb / downloads / guide-to-iec-62353-uk.pdf). This device must remain switched off. It can be operated without time restrictions. Metallic body implants such as dental and skull implants. The rules that must be followed during MRI imaging and examinations apply when performing these procedures on patients. will be. 20 The preliminary work we did while developing this device included the device's cables (2), the application head there will be no insulation problem at this voltage level inside the housing (1), control unit (3) This has been demonstrated. All wiring, assembly, diode selection, and dimmer connections involve general high voltage. Safety regulations will be observed (https: / / www.electricityforum.com / iep / arc-flash / high-voltage- (electrical safety). IEC60601-AAMI / NFPA 99 is a specific standard for medical devices, IEC 60601.1 25 Section 3 of the standard states that such sensitive devices can cause electric shock to the patient or the person using the device. It describes the requirements to protect against hazards. Section 3 covers Class 1 (sensitive medical devices). The points to be considered during assembly are explained. The device will be assembled in accordance with these instructions. It is structured. The device described in the invention offers a multi-functional advantage in terms of both ease of treatment and cost savings. 30 This will enable the device, which is the subject of this invention and will also lead to many new studies, to bypass the blood-brain barrier. Many studies will be conducted on this subject, contributing to science. The device in question will provide a non-invasive and inexpensive solution. This ensures that treatments are carried out in this way, drug dosages can also be reduced, and most importantly, science can be reformed. By contributing, it will play a key role in many studies.

Claims

11 REQUESTS 1. Blood from the brain used in the treatment of diseases such as meningitis, encephalitis, brain tumors, or lymphoma. The need for direct administration of drugs that cannot cross the cerebrospinal fluid (CSF) into the cerebrospinal fluid (CSF). by eliminating the need for drugs to be administered only intravenously, or by cutting the blood-brain barrier. drugs that cross the blood-brain barrier, allowing for a reduction in the dose of drugs that act by crossing the barrier, or drugs that open the blood-brain barrier or 5 It is a device that uses an electric field to control it, and its characteristic feature is; - head body (1) positioned non-invasively per patient (5), - plate (1.4) embedded in the mentioned head body (1), - Control unit (3) that provides electric field supply and control. It includes. 10 2. A device that opens or controls the blood-brain barrier in accordance with claim 1, and its feature is; head (5) This enables the direction of the electric field vector toward the target tissue in the mentioned region. It contains plate (1.4).

3. A device that opens or controls the blood-brain barrier, in accordance with any of the above requirements. The device's feature is that the supply voltage it receives from the mains is increased to a maximum of 15V via its internal step-up transformer. It increases the effective value up to 38 kV by transmitting a sinusoidal voltage waveform through a dimmer connected in series with the circuit. by slicing and thus halving the sinusoidal application voltage with high-voltage diodes connected in series. The aforementioned control unit (3) transmits the wave rectified to the aforementioned plates (1.4) It includes.

4. 20 that open or control the blood-brain barrier, in accordance with any of the above requirements. The device is characterized by the homogeneous electrical current of the patient's head (5) located under the mentioned head body (1). The aforementioned plate (1.4) increases the permeability of the blood-brain barrier by being exposed to the area. It is the fact that.

5. A device that opens or controls the blood-brain barrier, in accordance with any of the above requirements. The device is characterized by the fact that the mentioned monolithic head body (1) is semi-circular in shape. 25 6. A device that opens or controls the blood-brain barrier, in accordance with any of the above requirements. It is a device and its feature is that the upper part (1.1) which is within the patient’s field of vision is transparent, thus allowing the patient to see. It includes the aforementioned head body (1) which enables him to see around.

7. A device that opens or controls the blood-brain barrier, in accordance with any of the above requirements. The device is characterized by the fact that the mentioned upper part (1.1) is made of glass material. 30 12 8. A device that opens or controls the blood-brain barrier, in accordance with any of the above requirements. The device is characterized by the fact that the head body (1) is not visible from the outside, left and right The aforementioned CrNi material, embedded in the part (1.2, 1.3), is perpendicular and parallel to each other. It contains plate (1.4).

9. 5 that opens or controls the blood-brain barrier, in accordance with any of the above requirements. The device is characterized by the fact that the right and left parts (1.2, 1.3) of the mentioned head body (1) are made of PVC material. It is a manufactured product.

10. A device that opens or controls the blood-brain barrier, in accordance with any of the above requirements. The device's characteristic is that it is permanently connected to the operational grounding, eliminating the need for any electrical connection. The 10 embedded in the right part (1.3) of the mentioned head body (1) which provides protection against the risk of leakage. It contains plate (1.4).

11. A device that opens or controls the blood-brain barrier, in accordance with any of the above requirements. The device's characteristic feature is that it is connected to the output of an electric field generator via a high-voltage cable. The left part of the header (1.2) contains an embedded plate (1.4).

12. 15 that opens or controls the blood-brain barrier, in accordance with any of the above requirements. The device is characterized by the change in the supply voltage coming from the mentioned control unit (3) and the intermediate Thanks to their distance of 85 cm, they provide homogeneous currents with effective values ​​of 11.7 kV / m to 44.7 kV / m and a frequency of 50 Hz. It contains a plate (1.4) that generates electric field pulses.

13. In accordance with any of the above requirements, opening or controlling the blood-brain barrier. The device is characterized by being made of conductive materials and the mentioned control unit (3) and header are electrical 20 It includes connecting cables (2) that enable current transmission.

14. In accordance with any of the above requirements, opening or controlling the blood-brain barrier. The device is characterized by having a connection cable (2) to which the two ends fit, and a connection cable (2) to which the mentioned connection cable is connected. It contains a plug (3.3) that allows current to be drawn by plugging it into the socket.

15. 25 that opens or controls the blood-brain barrier, in accordance with any of the above requirements. The device is characterized by the electrical current to be applied to the patient from the mentioned control unit (3). It includes adjustment knobs (3.2) that allow setting the application time and the frequency of the cutting.

16. In accordance with any of the above requirements, opening or controlling the blood-brain barrier. The device is characterized by the magnitude of the electric field vector determined by the mentioned control unit (3). The application time is 30, the effective value of the high voltage pulses applied to the aforementioned plates (1.4). It includes a screen (3.1) that allows it to be displayed. 13 17. In accordance with any of the above requirements, opening or controlling the blood-brain barrier. The device is characterized by its wireless communication which enables remote control of the mentioned control unit (3). It includes the module.

18. In accordance with any of the above requirements, opening or controlling the blood-brain barrier. The device is characterized by its wireless communication module, which is designed for indoor communications. It is a Bluetooth communication module that uses the 2.4 to 2.48 GHz range.

19. A device that opens or controls the blood-brain barrier, in accordance with any of the above requirements. The device is characterized by the electric field value from the control unit (3) via the mentioned wireless communication module. It includes a remote control (4) that enables remote control of the frequency and application time.

20. 10 that open or control the blood-brain barrier, in accordance with any of the above requirements. The device's feature is that it wirelessly controls the duration of electric field application to the patient and the electric field itself. including an adjustment knob (4.2) and a display (4.1) that allows remote adjustment of the exposure level. The remote control (4) is.

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