Carotid artery vasodilatation device

Abstract

The invention to the creation of a carotid artery vasodilatation device that can be used both at home or in the emergency room in addition to drug treatment in cases such as occlusion of the carotid artery in the neck area, increases nitric oxide production mediated by endothelial nitric oxide synthase in the intact endothelial layer of the carotid artery, which will be on the inner surface of the neck collar, can be applied for certain periods of time for each patient, with intermittent or continuous operation function selections by means of its adjustable power circuits, affects only the lesion area without affecting the patient's peripheral blood vessels, can be used in cases where possible use of nitrates is contraindicated, prevents the decrease in blood flow that may occur in the brain tissue secondary to constriction in the neck veins, can be kept in the application area for a long time by means of the flexible structure of the applicator neck collar (9), and comprises pulsed magnetic field (PMF).

Description

[0001] CAROTID ARTERY VASODILATATION DEVICE

[0002] Technical Field

[0003] The subject of the invention relates to the creation of a carotid artery vasodilatation device that can be used both at home or in the emergency room in addition to drug treatment in cases such as occlusion of the carotid artery in the neck area, increases nitric oxide production mediated by endothelial nitric oxide synthase in the intact endothelial layer of the carotid artery, which will be on the inner surface of the neck collar, can be applied for certain periods of time for each patient, with intermittent or continuous operation function selections by means of its adjustable power circuits, affects only the lesion area without affecting the patient's peripheral blood vessels, can be used in cases where possible use of nitrates is contraindicated, prevents the decrease in blood flow that may occur in the brain tissue secondary to constriction in the neck veins, can be kept in the application area for a long time by means of its flexible structure, and comprises pulsed magnetic field (PMF).

[0004] Prior Art

[0005] Cerebrovascular accident, which we frequently encounter today, occurs due to health problems or develops suddenly. The term cerebrovascular accident (CVA) is a definition used for cerebral vascular occlusion, also commonly referred to as "stroke". The World Health Organization defines cerebrovascular disease, called "stroke", as clinical findings that occur due to rapidly developing focal or global cerebral disorder lasting 24 hours or longer, or the development of death. Stroke occurs in the form of cerebral ischemia in 60% to 80%, intracerebral haemorrhage in 10% to 15%, or subarachnoid haemorrhage in 3% to 10%. It is known that 12.2 million people worldwide have a stroke every year. The cause of death of 6.5 million people a year is recorded as stroke. In the future, one in every four people is likely to have at least one stroke in their lifetime. This number has increased by more than 50% in the last 17 years. There are many reasons for this situation. Especially high blood pressure, malnutrition and obesity are among the most common causes. In large artery atherosclerosis (thrombosis and embolism), ischemia develops due to thrombosis that occurs due to destabilization of atheroma plaques in intracranial, and especially in extracranial vessels and their bifurcation areas. This atherothrombotic condition leads to stenosis or occlusion of the vessel. Various neurological deficits can be observed in patients depending on the neuronal damage occurring distal to the occluded area and its location. Atherosclerosis of the bifurcation of the common carotid artery, which is one of the extracranial vascular occlusions, is an important cause of recurrent ischemic strokes, accounting for 20% of all strokes and the mortality rate varies between 10% and 30%. Multicentre randomised clinical studies show that surgical treatment is superior to medical treatment in symptomatic and asymptomatic carotid artery stenosis with more than 70% stenosis. In studies, the development of ipsilateral stroke within 5 years in asymptomatic patients with 50% carotid artery stenosis was found to be 4%, and in patients with 70% carotid artery stenosis, the development of ipsilateral stroke was found to be 8%. The risky patient group applies to high rates of stenosis with multiple risk factors. Especially the treatment of 50% or 60% stenosis is clinically important. Carotid Doppler ultrasound is used to identify and risk stratify carotid artery disease, but is not considered the gold standard for diagnosis. Especially those aged 65 and over, smoking, heart disease and hypertension are clinically important risk factors and are known to be more common in men. Carotid endarterectomy is a surgical procedure used to reduce the risk of stroke from carotid artery stenosis and prevent stroke from occurring. At the same time, controlling risk factors with regular treatments is also important to prevent the development of stroke and the problems that may occur after stroke. Randomised clinical studies have shown that carotid endarterectomy is a highly effective treatment option in patients with severe carotid artery stenosis and those who have had a transient ischemic attack or minor stroke. Although ischemic stroke indicates carotid artery disease, the absence of symptoms such as transient ischemic attack, dizziness, and visual disturbances in patients may lead to the misconception that they do not have carotid artery disease. However, it is useful to be skeptical in the high-risk atherosclerotic population. Ischemia is a restriction in blood flow to any tissue, muscle group or organ of the body, a pathology that causes a lack of oxygen necessary for cellular metabolism. Ischemia usually results from pathologies related to blood vessels, resulting in tissue damage or dysfunction, namely hypoxia and microvascular dysfunction. Ischemia occurs in the form of partial (poor perfusion) or complete occlusion. Atherosclerosis, which is the most common cause of ischemia, forms atheroma plaques in the coronary arteries, narrowing the vascular lumen over time and causing ischemia by reducing the blood flow after the plaque. In addition, oxidised LDLs accumulating in the subendothelial area behind the plaque and platelets adhering to collagen, one of the subendothelial structures protruding into the vascular lumen, also cause narrowing of the lumen. Molecules secreted from adhesive and degranulating platelets can cause platelet aggregation and vascular narrowing (TxA2-induced) and, through chemoattractant molecules, can attract other platelets to the lesion area to adhere. On the other hand, to ensure the stability of this platelet cluster, which plays a role in repairing the damaged area, fibrin, which is the end product of the pre-activated coagulation system, also contributes to keeping this clustered structure intact by covering the outside. I / R damage is not only due to events occurring in neurons, but is a pathological process in which the endothelium also actively participates. Since the endothelium, the innermost layer of the damaged area, is also damaged, nitric oxide (NO) synthesis, which contributes to vasodilatation in the vessels, may decrease and the vascular response shifts towards vasoconstriction. It is known that the resulting vasoconstriction increases the area of narrowing and increases the hypoxia in the distal tissue. The persistence of hypoxic conditions in the distal tissue due to ischemia may cause the expression of some markers that can trigger inflammation by triggering intracellular pathways such as hypoxic-inducible factor-1 alpha (Hif-1 a). While immediately eliminating the pathological process that causes ischemia allows reperfusion, the turbulent and strong flow occurring distal to the narrowed part can also damage the endothelium and cause it to re-enter the above-mentioned process.

[0006] Nitric oxide (NO) is a small biatomic molecule, also described as a free radical, consisting of one nitrogen and one oxygen atom, containing unshared electrons, acting as a weak oxidant or reducing component affecting many reactions. NO is a biological mediator present in almost every part of the organism, involved in various physiological and pathophysiological processes. While most of the molecules involved in signal transmission between cells, such as hormones, neurotransmitters and growth factors, serve as specific protein receptors that are often associated with the plasma membrane, NO diffuses out of the cell where it is produced and shows its effect by entering the target cell, where its specific molecular targets are located. NO causes blood vessels to dilate by directly relaxing vascular smooth muscle cells. When acetylcholine molecules bind to their receptor in endothelial cells, they cause an increase in the intracellular calcium (Ca) level, Ca-calmadulin binding occurs, and the Ca-calmodulin complex activates endothelial nitric oxide synthase (eNOS) and releases NO. The released NO diffuses out of the endothelial cell into the adjacent smooth muscle cell and binds to the heme group of guanylate cyclase. Guanylate cyclase provides relaxation in vascular smooth muscles by activating products such as cGMP and serial reactions of protein kinases. Since its half-life is 2-30 seconds in biological environments, the vasodilatation effect disappears spontaneously unless there is more NO product and it returns to its previous position. The release of NO into the circulatory system is also controlled by the autonomic nervous system. NO is secreted from nerve endings and diffuses from the outer surface of the vessel to the smooth muscle cell, causing vasorelaxation. NO is effective in the cardiovascular system, especially in areas around blood vessels. Nitric oxide (NO), produced by the endothelium from L-arginine, activates soluble guanylate cyclase in cells and platelets and, as mentioned, increases cGMP levels, inhibits phosphodiesterase with protein kinase G activation, and reduces platelet aggregation and adhesion. It is known that NO has antioxidant properties, anti-inflammatory and anti-apoptotic properties that can reduce the above-mentioned damage mechanisms. Nitrovasodilator drugs, which increase nitric oxide synthesis, can reduce blood pressure, especially by dilating peripheral arteries.

[0007] The document numbered RU2440833C1 in the state of the art describes the rehabilitation method of patients with cerebrovascular diseases. The method involves the application of general magnetic therapy in two stages against the background of basic rehabilitation treatment. In the first stage, the pulse is carried out for 10 minutes with a magnetic induction value of 3.5 mT and a pulse frequency of 100 Hz. In the second stage, impact on the upper body with rotating pulses of magnetic fields is performed in a prism configuration. The process continues with the use of general magnetotherapy using pulsed magnetic fields. This invention lacks an applicator or an operating control unit. However, the relevant document is used to increase blood flow rate. It does not cause any increase in nitric oxide synthesis by increasing the production of any endothelial nitric oxide synthase.

[0008] The prior art document numbered US10933251 B1 describes a system for non- invasive pulsed magnetic induction heating of acupuncture points for the neurorehabilitation of stroke and brain injury and the prevention or treatment of dementia (age-related cognitive decline) and depression. In said document, the heating system has a miniature tip equipped with an induction microcoil to periodically heat acupuncture points to temperatures between 44 and 50 degrees. The induction coil can generate a magnetic field, wherein such magnetic field induces eddy currents in the conductive parts of the acupuncture point area. Said document realised magnetic inductive heating, in which a dynamic magnetic field induces loop currents in a nearby conductor (in this case, the acupuncture point), and therefore eddy currents short-circuit the conductor and heat the conductor by magnetic induction heating. It does not cause any increase in nitric oxide synthesis by increasing the production of any endothelial nitric oxide synthase.

[0009] The document numbered KR102427694B1 in the state of the art describes the method of treating stenosis using pulsed magnetic field. The effect of a pulsed magnetic field on increasing blood flow is described. The pulsed magnetic field stimulation coil system used an elliptical concentric coil with a cross section of 12 cm wide and 4.5 cm long. The relevant document provides the process of changing or increasing the speed of movement of red blood cells. It does not cause any increase in nitric oxide synthesis by increasing the production of any endothelial nitric oxide synthase. The structure described in said document lacks an applicator, a pulsed magnetic field that works without closing, and the feature of not being affected by temperature and humidity.

[0010] The document numbered CN218280324U in the state of the art describes a pulsed magnetic field stimulator to treat hand movement dysfunction after stroke. It discloses a magnetic probe and a pulsed magnetic field exciter in which a rotating rotating disk is arranged in an internal cavity, with a fixed housing arranged on the left side of the magnetic probe. The fixed seat is rotatably coupled to the top of the rotating disk with a first rotating rod. The horizontal position of the magnetic probe is fixed and the surface of the magnetic probe is attached to the patient's head. This solves the problem that the probe of the current pulsed magnetic field stimulator usually needs to be held by the doctor to fix the position during actual use. The structure described in said document lacks an applicator, a pulsed magnetic field that works without closing, and the feature of not being affected by temperature and humidity. It is not used to treat or prevent diseases by increasing nitric oxide synthesis by increasing the production of any endothelial nitric oxide synthase.

[0011] The document numbered KR20210059345A in the state of the art describes a skin care device that uses a pulsed magnetic field and LED. Depending on the user's skin condition, it is intended to improve the user's skin by simultaneous irradiation of the magnetic field and LED beam on the face, neck and head, or by selective irradiation of either of them and the neck and head, including the face. It aims to remove toxins from the skin, increase blood circulation and oxygen efficiency, remove fat and relieve the symptoms of hair loss by using LED light and magnetic field simultaneously. It is not used to treat or prevent diseases by increasing nitric oxide synthesis by increasing the production of any endothelial nitric oxide synthase.

[0012] In the prior art document numbered US2011263925A1 , a pulsed magnetic therapy device is described. The aim of the device in the document is to provide an electrical circuit that supplies current to an induction coil device placed at the operating end of a hand-held apparatus for the purpose of inducing a pulsed magnetic field through a user's body. The device is described as sending pulsed magnetic fields into the body to reduce inflammation, increase immune function and increase blood flow. It is not used to treat or prevent diseases by increasing nitric oxide synthesis by increasing the production of any endothelial nitric oxide synthase.

[0013] Solutions in the state of the art restrict the use of drugs due to the fact that the use drugs, which are of primary importance in coronary artery stenosis, is undesirable in some cases such as bleeding, severe anemia, a disease that will increase intracranial pressure, and high eye pressure, and due to the lack of nitric oxide release, which will be produced and effective only in the area where it is applied, and similar systemic problems. The absence of a specific drug or device that can provide specific NO release to the lesion site in cases of stenosis that may occur in the carotid arteries has necessitated an R&D study in this field.

[0014] The Aim of the Invention

[0015] The main aim of the invention is to realise a low-cost carotid artery vasodilatation device that is used in cases such as occlusion of the carotid artery in the neck area and its prevention, is positioned in the neck area, configured to increase the production of nitric oxide mediated by endothelial nitric oxide synthase in the intact endothelial layer of the carotid artery, which corresponds to the inner surface of the flexible neck collar piece, contains a pulsed magnetic field (DMA) and does not cause painful stimuli.

[0016] The aim of the invention is to produce a carotid artery vasodilatation device that is portable and suitable for use by bedridden patients, can be fixed to patient beds, has a flexible neck collar device suitable for the neck form and has an adjustable bandage to ensure fixation during use.

[0017] Another aim of the invention is to produce a carotid artery vasodilatation device that contributes to vasodilatation in the area where it is applied, increases the synthesis of tissue growth factors such as vascular endothelial growth factor, stimulates the formation of connective tissue with its vasodilatation effect in wound healing and regeneration of damaged tissue, increases the myoblast population, and uses pulsed magnetic fields that reveal anti-inflammatory effects.

[0018] Another aim of the invention is to produce a carotid artery vasodilatation device, the magnetic field coils of which are produced as 200 turns of 10 cm x 5 cm in size from 0.3 mm diameter enamelled wire for the pulsed magnetic field unit, the coils creating a field value of 0.5 mT at 6 V supply voltage.

[0019] Another aim of the invention is to enable the frequency value to be used by the device to be adjusted in the range of 0 - 2 Hz and the power in the range of 0.1 mT - 1 mT with the adjustment buttons on the device.

[0020] The aim of the invention is to create a pulsed magnetic field in which the DC supply voltage of the magnetic field-producing inductive applicator is in the form of monophasic square waves, which can be operated at 1 Hz, where the DC supply voltage is one second on and one second off, that is, 50% duty cycle.

[0021] Another aim of the invention is to use coaxial cable to prevent the device from producing extra noise in the electromagnetic environment and being affected by ambient noise while carrying energy to the applicator.

[0022] Another purpose of the invention is to produce a carotid artery vasodilatation device whose operating range can be adjusted in 15-minute intervals and which is not affected by the humidity and temperature changes of the environment without ever shutting down (heavy duty). One of the aims of the invention is to create a carotid artery vasodilatation device that can operate without impairing EMC / EMI performance, without creating noise in the environment, without being affected by ambient noise, and without changing the electrical parameters in which it is set, and is able to deliver pulsed magnetic energy at a fixed frequency and constant amplitude at the target point and target values.

[0023] Description of Drawings

[0024] Figure - 1 General View of Carotid Artery Vasodilatation Device

[0025] Reference Numbers

[0026] 1. Control Unit

[0027] 2. Setting Unit

[0028] 3. Power Unit

[0029] 4. LCD Screen

[0030] 5. Power Cable

[0031] 6. Plug

[0032] 7. Applicator Cable

[0033] 8. Strap

[0034] 9. Neck Collar

[0035] Detailed Description of the Invention

[0036] The carotid artery vasodilatation device of the invention comprises a control unit (1 ), a setting unit (2) that provides control of setting the pulsed magnetic field at the target value with a potentiometer on said control unit (1 ), an LCD screen (4) that allows monitoring and control of the settings made and a power unit (3) that enables the device to be turned on and off. The power cable of the device is (5) - preferably - a shielded cable. With the carotid artery vasodilatation device of the invention, the applicator neck collar (9) receives energy via the applicator cable (7). The applicator cable (7) is preferably a coaxial cable. Electrical energy is obtained from the socket with the plug (6) at the end of the power cable (5). The neck collar (9) applicator is manufactured in a flexible structure and comprises a strap (8) for the patient's comfort and to prevent the applicator from slipping. (Figure - 1 )

[0037] Carotid artery vasodilatation device to be used to treat conditions such as occlusion of the carotid artery in the neck area comprises:

[0038] - coil that enables the creation of a pulsed magnetic field,

[0039] - control unit (1 ) that allows controlling magnetic field signals and setting the pulsed magnetic field parameters applied to the neck area,

[0040] - neck collar (9) that provides endothelial nitric oxide synthase-mediated nitric oxide synthesis in the intact endothelial layer of the carotid artery on the inner surface of the neck, by applying a regional pulsed magnetic field.

[0041] It also comprises a coil of 200 turns, made of 0.3 mm diameter enamelled copper conductor and allows creating a pulsed magnetic field of 0.5 mT (milli Tesla) at a supply voltage of 6 V (Volts). It comprises a coaxial applicator cable (7) that does not emit noise to the electromagnetic environment and ensures that it is not affected by ambient noise while carrying energy to said control unit (1) and the neck collar (9) applicator. It also comprises a shielded power cable (5) that provides the connection between the control unit (1 ) and the power supply. Said control unit (1 ) comprises at least one LCD screen (4) showing the parameters, a power unit (3) that enables the device to start or stop, and a setting unit (2) that allows the generated pulsed magnetic field to be controlled or for its strength to be changed. It comprises a neck collar (9) the outer surface of which is covered with a pillow case, by opening an area suitable for the patient's neck form. Said device has an adjustable strap (8) that allows said neck collar (9) to be fixed during use. It comprises said setting unit (2), which allows the frequency value to be used by said device to be set in the range of 0 to 2 Hz (Hertz) and the power in the range of 0.1 mT to 1 mT (field intensity). The applicator compries said coil, which produces a pulsed magnetic field in the form of monophasic square waves, which enables the direct current (DC) supply voltage of the collar (9) to operate with a 50% duty cycle of 1 Hz, being 1 second on and 1 second off.

[0042] The pulsed magnetic field provided by the device contributes to vasodilatation in the area where it is applied. It also increases the synthesis of tissue growth factors such as vascular endothelial growth factor. It has an analgesic effect in wound healing, regeneration of damaged tissue, stimulating the formation of connective tissue with its vasodilatation effect, increasing the myoblast population, revealing antiinflammatory effects and increasing the release of nitric oxide. A low-cost magnetic carotid artery vasodilatation device (NECK-EM) that does not cause painful stimuli is provided. This device is portable in size and has dimensions of 40 x 30 x 15 cm (centimetres), which is suitable for use by bedridden patients and can be fixed to patient beds. The neck collar (9) is structured by opening an area suitable for the neck form and its outer surface is covered with a pillow case. In this way, it is ensured that the patients continue their treatment comfortably throughout the procedure.

[0043] Pulsed magnetic field unit is produced so as to make sure that the magnetic field coils are of 200 turns and made of 0.3 mm (millimeter) diameter enameled wire with dimensions of 10 cm x 5 cm. It is known that the pre-studied coil creates a field value of 0.5 mT (milli Tesla) at 6 V (volt) supply voltage. Preliminary studies have shown that such application has no negative effect on the tissue. Therefore, it is suitable for routine use. With its ability to increase nitric oxide production on the vessels, its dilating effect helps to eliminate many pathologies in clinical use. A copper conductor with a diameter of 0.3 mm is used to create a pulsed magnetic field. It was prepared by printing the circuit diagram onto a copper plate. A power cable (5), preferably a shielded cable, is used for connection with the power supply. An adjustable strap (8) is used to secure the neck collar (9) while using the device. The device is turned on / off with the power unit (3) located on the control unit (1 ). At the same time, the control unit (1) comprises an LCD screen (4) and a potentiometer-like setting unit (2). The device body is made of durable material - preferably plastic coated on aluminium plate. (Figure - 1 )

[0044] The magnetic carotid artery vasodilatation device is called NECK-EM. The device is capable of providing a homogeneous pulsed electromagnetic field in the target area, with adjustable power, frequency and application time. The target magnetic field value is 0.5 mT (+ / - 10%). With the setting unit (2) on the device, the frequency value that the device will use is set in the range of 0 - 2 Hz (Hertz) and its power in the range of 0.1 mT - 1 mT (milli Tesla). The applicator neck collar (9), which is a removable application part and an accessory of the device, is inductive and its coil has the appropriate number of turns for the pulsed magnetic field. Thus, it is possible to produce a field with a vector perpendicular to the application area of 0.5 mT (+ / - 10%) within the desired setting range. The magnetic field-producing inductive applicator neck collar (9) can be operated with direct current (DC) supply voltage at 1 Hz, being 1 second on and 1 second off, that is, at 50% duty cycle. Thus, the magnetic field producing coils produce a pulsed magnetic field in the form of monophasic square waves at a 50% duty cycle under this intermittent supply. The rise time of the pulses is negligibly low. (less than 1 ps)

[0045] The device box carries energy to the applicator neck collar (9) via the applicator cable (7) - preferably coaxial cable or shielded cable. The applicator cable (7) is structured so that it does not produce extra noise in the electromagnetic environment and is not affected by ambient noise. The operating interval of the device is adjusted in 15-minute intervals. In addition, the device operates without shutting down (heavy duty) without being affected by the humidity and temperature changes in the environment. The device operates without disrupting EMC / EMI performance, without creating noise in the environment, without being affected by ambient noise and without changing the electrical parameters to which it is set. The device delivers pulsed magnetic energy at a fixed frequency and constant amplitude at the target point and at target values.

Claims

CLAIMS1. Carotid artery vasodilatation device to be used to treat conditions such as occlusion of the carotid artery in the neck area, comprising:- coil that enables the creation of a pulsed magnetic field,- control unit (1 ) that allows controlling magnetic field signals and setting the pulsed magnetic field parameters applied to the neck area,- neck collar (9) that provides endothelial nitric oxide synthase-mediated nitric oxide synthesis in the intact endothelial layer of the carotid artery on the inner surface of the neck, by applying a regional pulsed magnetic field.

2. Carotid artery vasodilatation device according to Claim 1 , comprising a 200 turns coil made of 0.3 mm diameter enamelled copper conductor.

3. Carotid artery vasodilatation device according to Claim 1 or Claim 2, comprising coil that allows creating a pulsed magnetic field with a field value of 0.5 mT (milli Tesla) at 6 V (Volt) supply voltage.

4. Carotid artery vasodilatation device according to any of the previous claims, comprising a coaxial applicator cable (7) that does not emit noise to the electromagnetic environment and ensures that it is not affected by ambient noise while carrying energy to said control unit (1 ) and the neck collar (9) applicator.

5. Carotid artery vasodilatation device according to any of the previous claims, comprising a shielded power cable (5) that provides the connection between said control unit (1 ) and the power supply.

6. Carotid artery vasodilatation device according to any of the previous claims, wherein said control unit (1 ) comprises:- at least one LCD screen (4) showing the parameters,- a power unit (3) that enables the device to start or stop, and- a setting unit (2) that allows controlling or changing the strength of the pulsed magnetic field produced.

7. Carotid artery vasodilatation device according to any of the previous claims, comprising a neck collar (9), the outer surface of which is covered with a pillow case and is created by opening an area suitable for the patient's neck form.

8. Carotid artery vasodilatation device according to any of the previous claims, comprising an adjustable strap (8) that ensures the fixation of said neck collar (9) during the use of said device.

9. Carotid artery vasodilatation device according to any of the previous claims, comprising said setting unit (2) that enables the frequency value to be used by said device to be set in the range of 0 to 2 Hz (Hertz) and the power in the range of 0.1 mT to 1 mT.

10. Carotid artery vasodilatation device according to any of the previous claims, comprising said coil that produces a pulsed magnetic field in the form of monophasic square waves, enabling the direct current (DC) supply voltage of the applicator collar (9) to operate at 1 Hz at a 50% duty cycle, being 1 second on and 1 second off.

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