A regulating helmet for children with increasing cerebrospinal fluid

Abstract

The invention of the intracranial pressure regulation helmet caused by cerebrospinal fluid is a means to control CSF in shunting surgery, which leads to the control of intracranial pressure and the removal of excess fluid inside the skull of children. This device can be used in patients with brain damage due to trauma, patients with hydrocephalus, swelling of the brain, bleeding or accumulation of blood in the brain, aneurysm of cerebral vessels, and brain infection caused by meningitis or encephalitis, brain tumor, lack of blood oxygen, increased cerebral pressure and abused children. The advantage of using this device after surgery is that it can be used by the patient's parents with prior training without the need for special expertise. This product consists of small and large parts with different thicknesses, which together form this orthosis by stitching and three straps.

Description

A Regulating Helmet for Children with Increasing Cerebrospinal Fluid

[0001] The intracranial pressure regulation helmet is an innovative device designed to regulate cerebrospinal fluid (CSF) in pediatric patients undergoing shunting surgery. This technology effectively manages intracranial pressure and facilitates the drainage of excess fluid from within the cranial cavity. It addresses a crucial need for a user-friendly and mechanically efficient device in this context.

[0002] This device offers versatile applications and can be employed in a variety of conditions, including traumatic brain injuries, hydrocephalus, brain edema, intracranial hemorrhage, cerebral aneurysms, and brain infections such as meningitis and encephalitis. Additionally, it is beneficial for patients with brain tumors, hypoxia, increased intracranial pressure, and victims of child abuse.

[0003] The post-operative use of this device is particularly advantageous, as it can be administered by parents following appropriate training, eliminating the necessity for specialized expertise. Comprising small and large components of varying thicknesses, the orthosis is assembled through stitching and secured in place by three straps, making it a comprehensive solution for managing intracranial pressure in pediatric patients.

[0004] G09B 23 / 28 – A61K 35 / 30

[0005] CN212326527

[0006] CEREBROSPINAL FLUID COLLECTING DEVICE IN LUMBAR PUNCTURE

[0007] A cerebrospinal fluid collecting device in lumbar puncture comprises a drainage tube, a connecting cap capable of being communicated with a puncture needle, a plurality of test tubes and a containingbox used for containing the test tubes, the drainage tube comprises a main drainage tube body and a plurality of branch drainage tube bodies communicated with the main drainage tube body, and the end of the main drainage tube body is connected with the connecting cap; wherein the branch drainage tubes respectively extend into the test tubes, a speed regulator is arranged on the main drainage tube, and a tube clamp is arranged on each branch drainage tube. The cerebrospinal fluid flow-out speed can be adjusted and controlled in real time, quantitative collection of cerebrospinal fluid after puncture is achieved, leakage is not prone to occurring, pollution risks are reduced, and meanwhile the workload in the collection process in the operation process is reduced.

[0008] The difference between this invention and our invention is that in this invention pump, atmospheric pressure, laminate, hard materials, and silicone gel have been used while we have not used laminate and hard materials but soft materials such as leather and fibers and also Styrofoam.

[0009] US10695484

[0010] SYSTEMS AND METHODS FOR LUMBAR CEREBROSPINAL FLUID ACCESS AND TREATMENT

[0011] System and method for accessing and treating a patient's cerebrospinal fluid. The system comprises a device with at least one implantable single or multilumen catheter, configured for placement along a patent's cerebrospinal fluid pathway, with at least one domed subcutaneous reservoir and / or pump connected to the catheter(s). The device can also be equipped with control circuitry and controllable valves. The devices allow for drug administration and / or simultaneous, bidirectional cerebrospinal fluid access and exchange. The catheter(s), may be coupled with medical probes that transmit sensor data to the device's processor, which can be configured transmit and receive data and instructions. The catheters may also be configured with guide devices to facilitate implantation. Various configurations, from single dome to multiple dome devices are taught, along with various applications such as epidural and other cerebrospinal drug administration, and various medical diagnostic applications.

[0012] This invention refers to a catheter and a lumen that can be implanted in the skull and a subcutaneous reservoir, as well as a pump device that is installed and operated by the surgeon in the operating room, while in our invention, none of these devices are used and only mechanically. After the surgery, the shunt is placed on the patient's head by a neurologist.

[0013] CN220309503

[0014] CEREBROSPINAL FLUID LEAKAGE DRAINAGE HELMET

[0015] The utility model relates to a cerebrospinal fluid leakage drainage helmet which comprises a helmet part and a shoulder and neck part fixedly connected with the helmet part, and a base is installed below the helmet part and the shoulder and neck part. The helmet part comprises a shell used for fixing the head of a patient, an inflation part attached to the head of the patient and a sterile cotton cushion attached to the inflation part. A through hole through which a cerebrospinal fluid leakage drainage tube passes is formed in the helmet part; the base comprises an upper seat for supporting the helmet part and the shoulder and neck part and a horizontal lower seat attached to the bed board, the upper seat is hinged to the lower seat, and an angle adjusting device, a sliding rod and a guide pipe are installed on the lower seat. The utility model aims to provide the drainage helmet for leakage of cerebrospinal fluid, so as to solve the phenomenon of abnormal drainage of the cerebrospinal fluid caused by incorrect body position of a patient with leakage of cerebrospinal fluid after operation during drainage and after drainage.

[0016] In this invention, a shoulder and neck part is fixed with the helmet part and a base is installed under the helmet part and the shoulder and neck part. which does not exist in our invention. There is also a sterile cotton pad attached to the swelling part, which is not used in our invention. In this invention, there is a through hole through which a cerebrospinal fluid leakage tube passes in the helmet part, but in our invention, the hole is not used and the cerebrospinal fluid is removed from under the device. In this invention, the base includes an upper seat to support the helmet part the shoulder and neck part, and a lower horizontal seat connected to the flat board, the upper seat is hinged to the lower seat and an angle adjustment device, a sliding rod, and a guide tube. It is installed on the lower seat, while in our invention, the base, the angle adjustment device, the sliding rod, and the guide tube are not used.

[0017] SE543899

[0018] A MEDICAL DEVICE FOR TREATMENT OF THE CENTRAL NERVOUS SYSTEM BY ELECTRO-OSMOSIS

[0019] The present invention relates to a medical device for inducing a controlled fluid transport in a central nervous system, CNS, and / or in a cerebrospinal fluid, CSF system, of a patient by electro-osmosis, EO, via two or more electrodes (221, 222, 223, 224, 225, 226, 227, 231) placed at selected locations on the patients head, comprising a computer program module, receiving EO information, the EO information being at least indicative of fluid transport response resulting from application of particular electric potentials and / or currents at particular electrode locations on the patient’s head based on a patient-specific threedimensional head model, receiving a fluid source location within the patient’s head, and selecting a set of electrode locations using the EO information and the fluid source location; a cap / helmet-like device (210), placing the two or more electrodes (221, 222, 223, 224, 225, 226, 227, 231) in electrical communication with said CNS / CSF-system, each electrode being placed at one location of the selected set of electrode locations; and a control unit (910), controlling an application of selected electric potentials and / or electric currents to said electrodes, wherein the selected electric potentials and / or electric currents is selected as electric potentials and / or electric currents associated to the selected set of electrode locations by the EO information, so as to induce a controlled fluid transport in said CNS / CSF-system.

[0020] In this invention, the controlled fluid transfer induction system in the central nervous system or the cerebrospinal fluid, the CSF system, the patient by electroosmosis, EO, through two or more electrodes are used, but in our invention, the induction system and electrodes are not used and electronics are used. His name is unknown. This patent consists of a computer program module that receives EO information and shows the fluid transfer response caused by the application of specific electric potentials or the current in specific electrode locations of the patient's head based on the patient's 3D head model, receiving the location of the fluid source in the head. The patient and the selection of a set of electrode locations using EO information and the location of the liquid source have spoken, which is not mentioned in my invention of the computer program module. In this invention, from a control unit (910), the control of a selected program of electric potentials or electric currents to said electrodes, where electric potentials or electric currents are selected as electric potentials or electric currents associated with the set A selection of electrode locations is selected by the selected EO information to induce controlled fluid transfer in the CNS / CSF-related system, whereas our invention is completely mechanical and no electronic components are used.

[0021] United States Patent Application 20120297526

[0022] Helmet System

[0023] A protective helmet includes a head cap, which surrounds and moves with a wearer's head, and an outer shell which surrounds the head cap. The outer shell is movable both radially and circumferentially relative to the head cap. An energy absorbing flexible liner is located between the head cap and the outer shell. The liner is attached to the outer shell and the head cap so that neither the head cap nor the head of the wearer is otherwise attached to the outer shell. The liner establishes a preset initial relative position and spacing between the head cap and the outer shell and compliantly absorbs energy imparted to the outer shell during a helmet impact to enable the outer shell to move relative to the head cap during the helmet impact and to be returned to the initial relative position with the head cap following the impact.

[0024] In this invention, there is an outer shell that surrounds the head cap, but our claimed invention does not have an outer shell or an inner shell. also, the outer shell is movable both radially and circumferentially relative to the head cap, but in our patent, all parts are fixed relative to each other. Moreover, A flexible energy-absorbing lining was used between the head cap and the outer shell, but in our design, no flexible lining was used.

[0025] A wearable helmet is designed to regulate cerebrospinal fluid in children, preventing excessive discharge and blood pressure when CSF secretion occurs. The device includes a natural leather cover and utilizes semi-hard materials and fibers to adjust pressure on the head. It features an asymmetric shape, hypoallergenic materials, and adjustable bands to prevent increased CSF pressure and fluid exit from the shunt tube. The helmet has different parts tailored to the severity of the disease, the age of the patient, and the needed pressure. Its design eliminates the need for additional surgery and is used after the initial surgery by placing the entire product set on the head like a frame.

[0026] For years, a device called a shunt was used to control the pressure of the skull caused by the increase in cerebrospinal fluid in patients suffering from high pressure caused by cerebrospinal fluid, and the need for surgeons for a more useful product increased day by day.

[0027] The purpose of this device is to control and regulate and reduce the increased pressure caused by brain CSF in hydrocephalic patients. Of course, secondary goals are also envisaged for the product, such as shaping the skull and preventing it from becoming bigger.Solution of Problem

[0028] First, we must know that the human brain is inside a liquid in the skull. The problem with encephalitis is the excessive secretion of this brain fluid due to the disease. During the onset of the disease, with the start of the secretion of CSF or brain fluid, the brain is under double pressure due to the harder and greater resistance of the bones of the skull, and the brain tissue is under more pressure and damage. If it is done late, the child may enter a phase of coma and unfortunately die, which is not rare in countries like Turkmenistan. The technical solution is the shunt operation, and the current product makes the work much more efficient and increases the number of patients saved.

[0029] The only device that existed in the past is called a hat or a helmet, which is different in its construction, appearance, function, purpose of construction, and use, so that it is made of plastic of different colors and has no holes in the head, in two sizes, small and large, and it is used only to correct the deformity of the skull of children. Therefore, it is not suitable for the control of cerebrospinal fluid and the purpose of this medical device was not to regulate CSF.

[0030] The product has a frontal part, a temporal part, an occiput part, and a peri-ental part. The front part of the forehead is opened and closed by velcro, each part has its shape, curvature, thickness, material, and pressure on a different surface, and these parameters vary based on the severity of the disease and the age of the patient and the amount of pressure required. The frontal piece is placed on the forehead and consists of two pieces that come from the left and right sides of the skull and are attached by two pieces of velcro. Due to the ease of opening and closing the device, it is less and is about two centimeters. The outer layer of this part is made of soft natural leather, and the inside is made of fibers and then sewn.

[0031] The next piece is the temporal or lateral piece that covers the left and right sides of the skull and is the only double piece that is in this product. The appearance of these two pieces is different based on the shape of the skull and the amount of pressure applied to the head and the location of the shunt. The inner layer of these two pieces Styrofoam, which is a semi-hard material, is formed, which continues from the top to the bottom behind the ear and from the back to the front and connects to the frontal piece. The thickness of these parts is between two inches and five centimeters. The part of the occiput or the back of the head is placed on the back of the head. The outer layer is made of soft natural leather, the inner part is semi-rigid or semi-hard material, such as Styrofoam, and it is connected to the parts and side components from both sides of the head by sewing. In addition, the main components of the product have smaller and more detailed components, including the patient's throat strap, which keeps the device in place like a hat. This strap should be soft and avoid irritating the skin under the throat. Therefore, it consists of regulatable male and female velcro with very soft foam. On the top of the head, some rings are sewn to the above-mentioned parts in which there is a strong cotton band that we can adjust and regulate the pressure on the patient’s head by pulling, loosening, and tightening.

[0032] At the bottom of the occipital part and the back of the neck, two velcro patches continue from the posterior part of the peri-ental parts and are attached at the back of the neck to prevent additional movements of the device. All parts are connected by sewing and its color is black. The whole product set is placed on the head as a frame.Advantage Effects of the Invention

[0033] • Regulating the Cerebrospinal fluid

[0034] • Shaping the skull

[0035] • Controlling the CSF of the brain

[0036] • Preventing the skull from getting bigger

[0037] shows an exploded view of the helmet.

[0038] shows the exploded pieces of the helmet from the side angel.

[0039] shows the whole helmet from the side view.

[0040] shows an exploded view of the helmet of which the details are:

[0041] 1- It shows a fabric strap to be placed inside ring number 2, which by pulling, loosening, and tightening it, we adjust the amount of pressure on the head.

[0042] 2- It displays the rings are located on the upper part of the helmet, it is leather, and the strap passes through it and secures the device on the upper part of the head.

[0043] 3- It is the forehead piece, which includes a ring around the head made of leather with Vionolite fibers, and in the front part, there is a male or female velcro that can adjust the pressure on the head.

[0044] 4- The two side pieces, left and right, are placed on the cheeks, and apply pressure from both sides. This part is the only double part of this device, the appearance of these two parts is different based on the shape of the skull and the amount of pressure applied to the head, and the location of the shunt. The inner layer of these two pieces is made of semi-hard material that continues from the top to the bottom behind the ear and from the back to the front and connects to the frontal piece. The thickness of these pieces is between two inches and five centimeters.

[0045] 5- The piece behind the head and the back of the neck is for keeping the device behind the head and preventing it from moving. The material of the outer layer is soft natural leather, and the inner layer is semi-rigid or semi-hard material, such as Styrofoam, and it is connected to the parts and side components from both sides of the head by sewing.

[0046] 6- The connecting hooks to number 4 on both sides.

[0047] 7- In the form of male and female sockets, hooked together with the number 8 socket so that the strap can be loosened and tightened like a backpack strap.

[0048] 8- In the form of male and female sockets, hooked together with the number 7 socket so that the strap can be loosened and tightened.

[0049] 9- The chin and throat pad is very soft and prevent damage to the strap due to the stiffness and roughness of the strap and prevents the child from scratching the throat.

[0050] Displays the exploded-view picture of the patent from the side angel in which all the pieces are shown in detail apart from each other.

[0051] presents the helmet from the side angel point of view when all the parts are connected and it is ready to be used.Examples

[0052] This product is used in the implementation of shunting surgery. In this way, after examining the patient and taking a three-dimensional photograph of the skull specifying the exact place where the tube exits from the skull and a three-dimensional measurement of the child's head, this specially made device is placed on the patient's head with a strap on the head and a strap under the chin. The strap behind the neck and back of the head is fixed and its pressure is adjusted.

[0053] The product is primarily utilized in the medical field, specifically in the areas concerning the brain, and nerves, as well as in procedures such as intubation or shunt insertion.

Claims

A wearable helmet is designed to regulate cerebrospinal fluid in children, which prevents the discharge of this substance and blood pressure in children when CSF secretion starts.According to claim 1, the device includes a natural leather cover that is completely sewn and hypoallergenic, semi-hard materials (Styrofoam) are used in some parts, and fibers are used in some areas to adjust, increase, and decrease the pressure on the head.According to claim 2, the technique used in this patent by creating curves and different thicknesses in the hat, the presence of an asymmetric shape, the use of hypoallergenic material, the ability to be adjusted by the bands placed on the head and the under-the-throat adhesives on the forehead and back of the head allow adjustment and prevent the increase Cerebrospinal fluid pressure and fluid exit from the shunt tube.According to claim 3, the product has a frontal part, a temporal part, an occiput part, and a peri-ental part. The front part of the forehead is opened and closed by Velcro, each part has its shape, curvature, thickness, material, and pressure on a different surface, and these parameters vary based on the severity of the disease and the age of the patient and also the amount of pressure required.According to claim 4, the direction of adjusting the child's head is the temporal or lateral piece that covers the left and right sides of the skull and is the only double piece in this product. The appearance of these two pieces is different based on the shape of the skull, the amount of pressure applied to the head, and the shunt's location. In the inner layer these two pieces of Styrofoam, which is a semi-hard material, are formed, which continue from the top to the bottom behind the ear and from the back to the front and connect to the frontal piece.According to claim 5, to use this device in the treatment of patients, there is no need to perform a separate surgery, and its use is after the surgery, and the entire product set is placed on the head like a frame.

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