Device for vasodilation of the carotid arteries

Abstract

A carotid vasodilator device for use in the treatment of conditions such as carotid artery occlusion in the neck, comprising: - a coil that enables the generation of a pulsed magnetic field, - a control unit (1) which enables the control of magnetic field signals and the adjustment of the pulsed magnetic field parameters applied to the neck area, - a cervical collar (9) providing 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.

Description

Technical field

[0001] The subject of the invention relates to the creation of a device for vasodilation of the carotid artery, which can be used both at home and in the emergency room in addition to drug treatment in cases such as occlusion or closure of the carotid artery in the neck region. The device increases endothelial nitric oxide synthase-mediated nitric oxide production in the intact endothelial layer of the carotid artery, which is located on the inner side of the cervical collar. The device can be applied to each patient for specific periods of time, with a choice of functions with intermittent or continuous operation by means of its adjustable electrical circuits, which only affect the lesion area without affecting the patient's peripheral blood vessels. The device can be used in cases where the possible use of nitrates is contraindicated.The device prevents the reduction in blood flow that can occur in brain tissue alongside constriction in the neck veins. Its flexible structure allows the device to be held in place for extended periods and incorporates a pulsed magnetic field (PMF). State of the art

[0002] A cerebrovascular accident, which we commonly encounter today, occurs due to health problems or develops suddenly. The term cerebrovascular accident (CVA) is a term used for cerebral vascular occlusion, also commonly referred to as a "stroke." The World Health Organization (WHO) defines cerebrovascular disease, also called a "stroke," as a clinical finding that occurs due to rapidly developing focal or global brain impairment lasting 24 hours or more, or the occurrence of death. Stroke occurs in the form of cerebral ischemia in 60% to 80%, intracerebral hemorrhage in 10% to 15%, or subarachnoid hemorrhage in 3% to 10%. It is known that 12.2 million people worldwide have a stroke each year.Stroke is recorded as the cause of death for 6.5 million people each year. In the future, one in 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. In particular, hypertension, malnutrition, and obesity are among the most common causes. In atherosclerosis of the large arteries (thrombosis and embolism), ischemia develops due to thrombosis, which occurs due to destabilization of atherosclerotic plaques in intracranial and especially 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 that occurs distal to the occluded area and its location.Atherosclerosis of the common carotid artery bifurcation, one of the extracranial vascular occlusions, is an important cause of recurrent ischemic stroke, accounting for 20% of all strokes, with a mortality rate ranging from 10% to 30%. Multicenter randomized clinical trials show that surgical treatment is superior to medical treatment for symptomatic and asymptomatic carotid artery stenosis with more than 70% stenosis. Studies have found that the development of an ipsilateral stroke within 5 years was 4% in asymptomatic patients with 50% carotid artery stenosis, and that the development of an ipsilateral stroke was 8% in patients with 70% carotid artery stenosis. The high-risk patient group is considered to be those with high stenosis rates and multiple risk factors. In particular, the treatment of 50% or 60% stenosis is clinically important.Carotid Doppler ultrasound is used to identify and assess the risk of carotid artery disease, but it is not considered the gold standard for diagnosis. Smoking, heart disease, and high blood pressure are clinically important risk factors, particularly in those aged 65 and older, and are known to be more common in men. Carotid endarterectomy is a surgical procedure used to reduce the risk of stroke due to carotid artery stenosis and to prevent stroke from occurring. At the same time, controlling risk factors with regular treatment is also important to prevent the development of stroke and the problems that can arise after a stroke.Randomized clinical trials have shown that carotid endarterectomy is a highly effective treatment option for patients with severe carotid artery stenosis and those with a transient ischemic attack or minor stroke. Although an ischemic stroke indicates carotid artery disease, the absence of symptoms such as a transient ischemic attack, dizziness, and visual disturbances may lead patients to misconceive carotid artery disease. However, it is useful to be skeptical in populations at high risk of atherosclerosis. Ischemia is a restriction of 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 typically results from pathologies related to blood vessels, leading to tissue damage or dysfunction, namely hypoxia and microvascular dysfunction. Ischemia occurs in the form of partial (poor perfusion) or complete occlusion. Atherosclerosis, the most common cause of ischemia, forms atherosclerotic plaques in the coronary arteries, which narrow the vessel lumen over time and cause ischemia by reducing blood flow past the plaque. Additionally, oxidized LDLs that accumulate in the subendothelial space behind the plaque and platelets attached to collagen, one of the subendothelial structures projecting into the vessel lumen, also cause lumen narrowing.Molecules secreted by adhesive and degranulating platelets can cause platelet aggregation and vasoconstriction (TxA2-induced), and can attract other platelets to the lesion area through chemoattractant molecules to adhere. On the other hand, fibrin, the end product of the pre-activated coagulation system, also contributes to maintaining the integrity of this clustered structure by coating the exterior to ensure the stability of this platelet cluster, which plays a role in the repair of the damaged area. I / R injury is not only due to events occurring in neurons but is a pathological process in which the endothelium also plays an active role.Because the endothelium, the innermost layer of the damaged area, is also damaged, nitric oxide (NO) synthesis, which contributes to vasodilation in the vessels, may decrease, and the vascular response shifts toward vasoconstriction. The resulting vasoconstriction is known to increase the area of ​​constriction and increase hypoxia in distal tissues. The persistence of hypoxic conditions in distal tissues due to ischemia can cause the expression of some markers that can induce inflammation by triggering intracellular pathways, such as hypoxy-induced factor-1 alpha (Hif-1α). While the immediate elimination of the ischemia-causing pathological process allows for reperfusion, the turbulent and vigorous flow distal to the constricted part can also damage the endothelium and cause it to re-enter the aforementioned process.

[0003] Nitric oxide (NO) is a small diatomic molecule, also described as a free radical, consisting of one nitrogen and one oxygen atom, which contains free electrons and acts as a weak oxidizing agent 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 molecules involved in cell-to-cell signaling, such as hormones, neurotransmitters, and growth factors, serve as specific protein receptors, often associated with the plasma membrane, NO diffuses from the cell in which it is produced and exerts its effects 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 intracellular calcium (Ca) levels. Ca-calmadulin binding occurs, and the Ca-calmodulin complex activates endothelial nitric oxide synthase (eNOS) and releases NO. The released NO diffuses from the endothelial cell into the adjacent smooth muscle cell and binds to guanylate cyclase (also known as guanylyl cyclase) via the heme group. Guanylate cyclase provides relaxation in vascular smooth muscle by activating products such as cGMP and serial reactions of protein kinases. Because its half-life in biological environments is 2–30 seconds, the vasodilation effect spontaneously disappears unless more NO product is present, 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 cells, causing vasorelaxation. NO is active in the cardiovascular system, particularly in areas surrounding 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 activation of protein kinase G, and reduces platelet aggregation and adhesion. NO is known to exhibit antioxidant, anti-inflammatory, and antiapoptotic properties, which can reduce the aforementioned damage mechanisms. Nitrovasodilator drugs that increase nitric oxide synthesis can reduce blood pressure, particularly by dilating peripheral arteries.

[0004] Prior art document RU2440833C1 describes a rehabilitation procedure for patients with cerebrovascular diseases (cerebral circulation disorders). The procedure involves the application of general magnetic therapy in two stages against the background of basic rehabilitation treatment. In the first stage, pulse therapy is performed for 10 minutes with a magnetic induction value of 3.5 mT and a pulse frequency of 100 Hz. In the second stage, the upper body is exposed to rotating pulses of magnetic fields in a prism configuration. The process continues with the use of general magnetic therapy using pulsed magnetic fields. This application lacks an applicator or operating control unit. However, the relevant document uses it to increase blood flow.It does not increase nitric oxide synthesis by increasing the production of any endothelial nitric oxide synthase.

[0005] Prior art document US10933251B1 describes a system for noninvasive pulsed magnetic induction heating of acupuncture points for neurorehabilitation of strokes and brain injuries, and the prevention or treatment of dementia (age-related cognitive decline) and depression. In this document, the heating system comprises a miniature tip equipped with an induction microcoil to periodically heat acupuncture points to temperatures between 44 and 50 degrees Celsius. The induction coil can generate a magnetic field, which induces eddy currents in the conductive parts of the acupuncture point area.This paper implements magnetic induction 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 through magnetic induction heating. It does not increase nitric oxide synthesis by increasing the production of any endothelial nitric oxide synthase.

[0006] Prior art document KR102427694B1 describes a method for treating stenosis using pulsed magnetic fields. The effect of a pulsed magnetic field on increasing blood flow is described. The pulsed magnetic field stimulation coil system utilized an elliptical concentric coil with a cross-section of 12 cm wide and 4.5 cm long. The relevant document describes the process of changing or increasing the movement speed of red blood cells. It does not increase nitric oxide synthesis by increasing the production of any endothelial nitric oxide synthase. The design described in this document lacks an applicator, a pulsed magnetic field that operates without closure, and the feature of not being affected by temperature and humidity.

[0007] Prior art document CN218280324U describes a pulsed magnetic field stimulator for treating hand movement dysfunction after a stroke. It discloses a magnetic probe and a pulsed magnetic field exciter, in which a rotating turntable is arranged in an internal cavity, with a fixed housing located on the left side of the magnetic probe. The fixed housing is rotatably coupled to the top of the turntable by 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 physician to fix the position during actual use.The design described in this document lacks an applicator, a pulsed magnetic field that operates without closure, and the feature of being unaffected by temperature and humidity. It is not used to treat or prevent diseases by increasing nitric oxide synthesis, specifically by increasing the production of any endothelial nitric oxide synthase.

[0008] Prior art document KR20210059345A describes a skin care device that uses a pulsed magnetic field and an LED. Depending on the user's skin condition, it is intended to improve the user's skin by simultaneously irradiating the face, neck, and head with the magnetic field and the LED beam, or by selectively irradiating the neck and head, including the face, with either the magnetic field or the LED beam. 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 a magnetic field simultaneously. It is not used to treat or prevent any disease by increasing nitric oxide synthesis, specifically by increasing the production of any endothelial nitric oxide synthase.

[0009] Prior art document US2011263925A1 describes a pulsed magnetic therapy device. The objective of the device in the document is to provide an electrical circuit that delivers current to an induction coil device placed at the operating end of a handset to induce a pulsed magnetic field through a user's body. The device is described as sending pulsed magnetic fields into the body to reduce inflammation, enhance immune function, and increase blood flow. It is not used to treat or prevent disease by increasing nitric oxide synthesis, specifically by increasing the production of any endothelial nitric oxide synthase.

[0010] Prior art solutions limit the use of drugs due to the fact that the use of drugs 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 is produced and effective only in the area where it is applied, and similar systemic problems. The lack of a specific drug or device capable of providing specific NO release to the lesion site in cases of stenosis that can occur in the carotid arteries has necessitated R&D study in this field. Aim of the invention

[0011] The main objective of the invention is to realize a cost-effective carotid artery vasodilator device used in cases such as carotid artery occlusion in the neck region and its prevention, positioned in the neck region and configured to increase endothelial nitric oxide synthase-mediated production of nitric oxide in the intact endothelial layer of the carotid artery, corresponding to the inner surface of the flexible cervical collar, containing a pulsed magnetic field (DMA) and not causing painful stimuli.

[0012] The object of the invention is to provide a carotid artery vasodilator device that is portable and suitable for use by bedridden patients, can be fixed to patient beds, has a flexible cervical collar device suitable for the neck shape, and has an adjustable bandage to ensure fixation during use.

[0013] Another object of the invention is to provide a carotid vasodilator device that contributes to vasodilation 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 vasodilatory effect in wound healing and regeneration of damaged tissue, increases the myoblast population, and uses pulsed magnetic fields that exhibit anti-inflammatory effects.

[0014] Another object of the invention is to provide a carotid artery vasodilator device having magnetic field coils made of 200 turns of enameled wire measuring 10 cm x 5 cm and 0.3 mm in diameter for the pulsed magnetic field unit, the coils generating a field value of 0.5 mT at a supply voltage of 6 V.

[0015] Another object of the invention is to enable the frequency value to be used by the device to be set in the range of 0 - 2 Hz and the power in the range of 0.1 mT - 1 mT using the setting buttons on the device.

[0016] The object of the invention is to generate a pulsed magnetic field in which the DC supply voltage of the magnetic field generating inductive applicator is in the form of single-phase square waves that can be operated at 1 Hz, with the DC supply voltage being on for one second and off for one second, i.e. 50% duty cycle.

[0017] Another object of the invention is to use coaxial cables to prevent the device from generating additional noise in the electromagnetic environment and being affected by environmental noise while transmitting energy to the applicator.

[0018] Another object of the invention is to provide a carotid vasodilator whose operating range can be adjusted in 15-minute intervals and which is unaffected by ambient humidity and temperature changes, never shutting down (high operation). One of the objects of the invention is to provide a carotid vasodilator that can operate without compromising EMC / EMI performance, without generating ambient noise, without being affected by ambient noise, and without changing the electrical parameters in which it is set, and is capable of delivering pulsed magnetic energy at a fixed frequency and constant amplitude to the target point and target values. Description of the drawings Fig. 1 General view of the carotid artery vasodilator device Reference symbol 1 control unit 2 adjustment unit 3 Power supply unit 4 LCD screen 5 power cables 6 plugs 7 applicator cables 8 volumes 9 Collar Detailed description of the invention

[0019] The device for vasodilating the carotid arteries according to the invention comprises a control unit (1), an adjustment unit (2) that controls the setting of the pulsed magnetic field to the desired value using a potentiometer on the control unit (1), an LCD screen (4) that enables monitoring and control of the settings made, and a power supply unit (3) that enables the device to be switched on and off. The power cable (5) of the device is preferably a shielded cable. In the device for vasodilating the carotid arteries according to the invention, the applicator collar (9) receives power via the applicator cable (7). The applicator cable (7) is preferably a coaxial cable. Electrical power is obtained from the socket with the plug (6) at the end of the power cable (5).The cervical collar applicator (9) is made of a flexible structure and includes a strap (8) for patient comfort and to prevent the applicator from slipping. (. Fig. 1)

[0020] The carotid vasodilator device for use in the treatment of conditions such as carotid artery occlusion in the neck comprises: - a coil that enables the generation of a pulsed magnetic field, - a control unit (1) which enables the control of magnetic field signals and the adjustment of the pulsed magnetic field parameters applied to the neck area, - a cervical collar (9) providing 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.

[0021] It also includes a 200-turn coil made of enameled copper conductor with a diameter of 0.3 mm, which generates a pulsed magnetic field of 0.5 mT (millitesla) at a supply voltage of 6 V (volts). It includes a coaxial applicator cable (7) that emits no noise to the electromagnetic environment and ensures that it is not affected by ambient noise while transmitting energy to the control unit (1) and the cervical collar applicator (9). It also includes a shielded power cable (5) that connects the control unit (1) to the power supply. The control unit (1) includes at least one LCD screen (4) that displays the parameters, a power supply unit (3) that starts or stops the device, and an adjustment unit (2) that allows the generated pulsed magnetic field to be controlled or its strength to be changed.It comprises a cervical collar (9) whose outer surface is covered with a cushion casing to thereby open up an area suitable for the patient's neck shape. The device has an adjustable band (8) that allows the cervical collar (9) to be fixed during application. It comprises the adjustment unit (2) that allows the frequency value to be set by the device in the range of 0 to 2 Hz (Hertz) and the power in the range of 0.1 mT to 1 mT (field strength). The applicator comprises the coil that generates a pulsed magnetic field in the form of single-phase square waves, which allows the direct current (DC) supply voltage of the collar (9) to operate at a 50% duty cycle of 1 Hz, which is 1 second on and 1 second off.

[0022] The pulsed magnetic field provided by the device contributes to vasodilation in the area where it is applied. It also increases the synthesis of tissue growth factors such as vascular endothelial growth factor. It exerts an analgesic effect in wound healing and in the regeneration of damaged tissue, stimulates the formation of connective tissue with its vasodilatory effect, increases the myoblast population, exhibits anti-inflammatory effects, and increases the release of nitric oxide. A cost-effective carotid magnetic vasodilator (NECK-EM) is provided that does not cause painful stimuli. This device is portable in size, measuring 40 x 30 x 15 cm (centimeters), making it suitable for use by bedridden patients and can be fixed to patient beds.The cervical collar (9) is structured to open an area suitable for the neck shape, and its outer surface is covered with a cushion casing. This ensures that patients continue their treatment comfortably throughout the procedure.

[0023] The pulsed magnetic field unit is manufactured to ensure that the magnetic field coils have 200 turns and are made of 0.3 mm (millimeter) diameter enameled wire with dimensions of 10 cm x 5 cm. The pre-tested coil is known to generate a field value of 0.5 mT (millitesla) at a supply voltage of 6 V (volts). Preliminary studies have shown that such application has no adverse effects on tissue, making it suitable for routine use. With its ability to increase nitric oxide production on the vessels, its dilating effect helps eliminate many pathologies in clinical use. A copper conductor with a diameter of 0.3 mm is used to generate a pulsed magnetic field. It was prepared by printing the circuit diagram on a copper plate. A power cable (5), preferably a shielded cable, is used to connect to the power supply.An adjustable strap (8) is used to secure the collar (9) during use of the device. The device is switched on / off using the power supply unit (3) located on the control unit (1). The control unit (1) also includes an LCD screen (4) and a potentiometer-like adjustment unit (2). The device body is made of a durable material—preferably plastic coated on an aluminum plate. Fig. 1)

[0024] The magnetic vasodilator for neck collars is called NECK-EM. The device is capable of delivering a homogeneous pulsed electromagnetic field to the target area with adjustable power, frequency, and application time. The target magnetic field value is 0.5 mT (+ / - 10%). Using the adjustment unit (2) on the device, the frequency value used by the device is set within the range of 0–2 Hz (Hertz) and its power within the range of 0.1 mT–1 mT (milli Tesla). The applicator collar (9), a removable application part and accessory of the device, is inductive, and its coil has the appropriate number of turns for the pulsed magnetic field. This makes it possible to generate a field with a vector perpendicular to the application area of ​​0.5 mT (+ / - 10%) within the desired adjustment range.The magnetic field-generating inductive applicator collar (9) can be operated with a direct current (DC) supply voltage of 1 Hz, which is on for 1 second and off for 1 second, i.e., at a 50% duty cycle. Thus, the magnetic field-generating coils generate a pulsed magnetic field in the form of single-phase square waves at a 50% duty cycle under this intermittent supply. The rise time of the pulses is negligible (less than 1 µs).

[0025] The device box transmits energy to the applicator collar (9) via the applicator cable (7) – preferably a coaxial cable or a shielded cable. The applicator cable (7) is structured so that it does not generate additional noise in the electromagnetic environment and is not affected by environmental noise. The device's operating interval is set at 15-minute intervals. In addition, the device operates without shutdown (high-power operation) and without being affected by changes in humidity and temperature of the environment. The device operates without compromising EMC / EMI performance, without generating noise in the environment, without being affected by environmental noise, and without changing the electrical parameters in which it is set. The device delivers pulsed magnetic energy at a fixed frequency and constant amplitude to the target point and at the target values. QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] RU 2440833C1

[0004] US 10933251B1

[0005] KR 102427694B1

[0006] CN 218280324U

[0007] KR 20210059345A

[0008] US 2011263925A1

[0009]

Claims

[1] A carotid vasodilator device for use in the treatment of conditions such as occlusion of the carotid arteries in the neck, comprising: - a coil that enables the generation of a pulsed magnetic field, - a control unit (1) which enables the control of magnetic field signals and the adjustment of the pulsed magnetic field parameters applied to the neck area, - a cervical collar (9) providing 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] A carotid vasodilator according to claim 1, comprising a 200-turn coil made of a varnished copper conductor having a diameter of 0.3 mm. [3] A carotid vasodilator according to claim 1 or claim 2, comprising a coil capable of generating a pulsed magnetic field having a field value of 0.5 mT (millitesla) at a supply voltage of 6 V (volts). [4] A carotid vasodilator device according to any one of the preceding claims, comprising a coaxial applicator cable (7) which does not emit noise to the electromagnetic environment and ensures that it is not affected by ambient noise while transmitting energy to the control unit (1) and the applicator of the cervical collar (9). [5] A carotid vasodilator device according to any one of the preceding claims, comprising a shielded power cable (5) providing the connection between the control unit (1) and the power supply. [6] Device for vasodilating the carotid arteries according to one of the preceding claims, wherein the control unit (1) comprises: - at least one LCD screen (4) showing the parameters, - a power supply unit (3) enabling the device to be started or stopped, and - an adjustment unit (2) which makes it possible to control or change the strength of the generated pulsed magnetic field. [7] A carotid vasodilator according to any preceding claim, comprising a neck collar (9) having an outer surface covered with a cushion casing and created by opening a region suitable for the shape of the patient's neck. [8] Device for vasodilating the carotid arteries according to one of the preceding claims, comprising an adjustable band (8) which ensures the fixation of the cervical collar (9) during use of the device. [9] Device for vasodilating the carotid arteries according to one of the preceding claims, comprising the adjustment unit (2) which makes it possible to adjust the frequency value to be used by the device in the range from 0 to 2 Hz (Hertz) and the power in the range from 0.1 mT to 1 mT. [10] A carotid vasodilator device according to any one of the preceding claims, comprising the coil generating a pulsed magnetic field in the form of single-phase rectangular waves, enabling the direct current (DC) supply voltage of the applicator collar (9) to be operated at 1 Hz with a 50% duty cycle which is 1 second on and 1 second off.

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