Carotid artery dilation device

Abstract

This utility model relates to an innovation of a carotid artery vasodilator that can be used at home and in the emergency room as a supplement to drug treatment for conditions such as carotid artery obstruction in the neck region. It increases the production of nitric oxide mediated by endothelial nitric oxide synthase in the intact endothelial layer of the carotid artery, which is located on the inner surface of the neck brace. It can be applied for a certain period of time for each patient. The intermittent or continuous operation function can be selected through an adjustable power circuit. It only affects the lesion area and does not affect the patient's peripheral blood vessels. It can be used in situations where nitrates may be prohibited. It prevents the reduction of blood flow to the brain tissue that may occur due to jugular venous constriction. The flexible structure of the applicator neck brace (9) can be maintained in the application area for a long time and includes a pulsed magnetic field (PMF).

Description

Technical Field

[0001] This invention relates to an innovative carotid artery vasodilator that can be used at home and in the emergency room as a supplement to drug treatment for conditions such as carotid artery obstruction in the neck region. It increases nitric oxide production mediated by endothelial nitric oxide synthase in the intact endothelial layer of the carotid artery. Located on the inner surface of a cervical collar, it can be applied for a specific duration for each patient. An adjustable power circuit allows for intermittent or continuous operation, affecting only the affected area without impacting the patient's peripheral blood vessels. It can be used in situations where nitrates may be contraindicated, preventing potential reduction in cerebral blood flow due to jugular venous constriction. Its flexible structure allows it to remain in the application area for extended periods and incorporates a pulsed magnetic field (PMF). Background Technology

[0002] Cerebrovascular accidents, which we frequently encounter today, occur due to health problems or happen suddenly. The term cerebrovascular accident (CVA) refers to a blockage in a blood vessel in the brain, often also called a "stroke." The World Health Organization defines cerebrovascular disease (called a "stroke") as a clinical manifestation resulting from rapidly developing focal or global brain dysfunction lasting 24 hours or longer, or progressing to death. Strokes take the form of cerebral ischemia (60% to 80%), intracerebral hemorrhage (10% to 15%), and subarachnoid hemorrhage (3% to 10%). It is known that 12.2 million people worldwide suffer a stroke each year. 6.5 million people die from stroke annually. In the future, one in four people may experience at least one stroke in their lifetime. This number has increased by more than 50% in the past 17 years. There are many causes for this, with high blood pressure, malnutrition, and obesity being the most common. Atherosclerosis of large arteries (thrombosis and embolism) is caused by the formation of thrombi due to instability of atherosclerotic plaques in intracranial, particularly extracranial, vessels and their bifurcations, leading to ischemia. This atherosclerotic thrombosis can cause stenosis or occlusion of blood vessels. Depending on the extent and location of neuronal damage distal to the occlusion area, patients may experience various neurological deficits. Atherosclerosis at the bifurcation of the common carotid artery is one type of extracranial vascular occlusion and a significant cause of recurrent ischemic stroke, accounting for 20% of all strokes and with a mortality rate between 10% and 30%. Multicenter randomized clinical studies have shown that surgical treatment is superior to drug treatment for both symptomatic and asymptomatic carotid artery stenosis (stenosis rate exceeding 70%). Studies have found that asymptomatic patients with 50% carotid artery stenosis have a 4% chance of developing an ipsilateral stroke within 5 years, while patients with 70% carotid artery stenosis have an 8% chance. High-risk patients are those with high stenosis rates and multiple risk factors. Treatment of 50% or 60% stenosis is particularly clinically important. Carotid Doppler ultrasound is used to identify and risk-stratify carotid artery disease, but it is not considered the gold standard for diagnosis. Smoking, heart disease, and hypertension are clinically significant risk factors, especially in people over 65, and are known to be more common in men. Carotid endarterectomy is a surgical procedure used to reduce the risk of stroke caused by carotid artery stenosis and to prevent stroke. Simultaneously, controlling risk factors through routine treatment is also important for preventing stroke development and potential post-stroke problems. Randomized clinical studies have shown that carotid endarterectomy is a very effective treatment option for patients with severe carotid artery stenosis and those who have experienced transient ischemic attacks or minor strokes. Although ischemic stroke indicates the presence of carotid artery disease, the absence of symptoms such as transient ischemic attacks, dizziness, and visual disturbances can lead people to mistakenly believe they do not have carotid artery disease. However, it is helpful to maintain a skeptical attitude towards high-risk individuals with atherosclerosis. Ischemia refers to restricted blood flow to any tissue, muscle group, or organ in the body; this pathology results in insufficient oxygen for cellular metabolism.Ischemia is typically caused by vascular-related pathologies leading to tissue damage or dysfunction, namely hypoxia and microvascular dysfunction. Ischemia occurs in the form of partial (poor perfusion) or complete occlusion. Atherosclerosis is the most common cause of ischemia, forming atherosclerotic plaques in the coronary arteries that narrow the lumen over time and cause ischemia due to reduced blood flow after plaque formation. Additionally, the accumulation of oxidized low-density lipoproteins in the subendothelial region behind the plaque, and platelet adhesion to collagen (a subendothelial structure protruding into the lumen), also contribute to luminal narrowing. Adhesion and degranulation of platelet secretions can lead to platelet aggregation and vascular narrowing (TxA2-induced) and attract other platelets to adhere to the lesion area via chemotactic molecules. On the other hand, fibrin, a final product of the pre-activated coagulation system, also helps maintain the integrity of this cluster structure by covering the outside, ensuring the stability of platelet clusters (which play a role in repairing damaged areas). I / R injury is not only due to events occurring in neurons, but also a pathological process in which endothelial cells actively participate. Because the innermost endothelial cells in the damaged area are also impaired, the synthesis of nitric oxide (NO), which aids in vasodilation, may decrease, and the vascular response shifts towards vasoconstriction. It is well known that this vasoconstriction increases the area of ​​stenosis and increases hypoxia in distal tissues. The persistent hypoxia in distal tissues due to ischemia may lead to the expression of markers such as hypoxia-inducible factor-1alpha (Hif-1α), which can trigger inflammation by inducing intracellular pathways. While immediate elimination of the pathological processes causing ischemia can achieve reperfusion, turbulence and strong currents occurring distal to the stenosis can also damage the endothelium, causing it to re-enter these processes.

[0003] Nitric oxide (NO) is a small diatomic molecule, also known as a free radical, composed of one nitrogen atom and one oxygen atom, containing unshared electrons. It can act as a weak oxidizing agent or reducing agent, influencing many reactions. NO is a biological mediator, present in almost every part of an organism, and involved in a wide range of physiological and pathophysiological processes. While most molecules involved in intercellular signaling (such as hormones, neurotransmitters, and growth factors) act as specific protein receptors, which are typically associated with the plasma membrane, NO diffuses out of the cells from which it is produced and exerts its effects by entering target cells where its specific molecular targets reside. NO causes vasodilation by directly relaxing vascular smooth muscle cells. When acetylcholine molecules bind to receptors in their endothelial cells, they cause an increase in intracellular calcium (Ca) levels, leading to Ca-calmodulin binding. The Ca-calmodulin complex activates endothelial nitric oxide synthase (eNOS) and releases NO. The released NO diffuses from the endothelial cells to neighboring smooth muscle cells and binds to the heme groups of guanylate cyclase. Guanylate cyclase relaxes vascular smooth muscle through a series of reactions that activate products such as cGMP and protein kinase. Due to its half-life of 2-30 seconds in the biological environment, the vasodilatory effect will disappear spontaneously unless more NO products are produced and return to their previous positions. 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 blood vessels into smooth muscle cells, causing vasodilation. NO is effective in the cardiovascular system, particularly in the perivascular region. Nitric oxide (NO) is produced from L-arginine by endothelial cells, activating soluble guanylate cyclase in cells and platelets, and, as mentioned above, increasing cGMP levels, inhibiting phosphodiesterase and protein kinase G activation, and reducing platelet aggregation and adhesion. NO is known to possess antioxidant, anti-inflammatory, and anti-apoptotic properties, which can reduce the aforementioned damaging mechanisms. Nitro vasodilators that increase nitric oxide synthesis can lower blood pressure, especially by dilating peripheral arteries.

[0004] Prior art document RU2440833C1 describes a rehabilitation method for patients with cerebrovascular disease. This method involves applying general magnetic therapy in two phases within the context of basic rehabilitation treatment. In the first phase, pulses are applied for 10 minutes at a magnetic induction value of 3.5 mT and a pulse frequency of 100 Hz. In the second phase, rotating magnetic field pulses are applied to the upper body in a prismatic configuration. This process is then continued using pulsed magnetic fields through comprehensive magnetic therapy. This invention lacks an applicator or operation control unit. However, related literature uses methods to increase blood flow rate. It does not lead to an increase in nitric oxide synthesis by increasing the production of any endothelial nitric oxide synthase.

[0005] Prior art document US10933251 B1 describes a non-invasive pulsed magnetic induction heating system for acupoints, used in neurological rehabilitation of stroke and brain injury, as well as for the prevention or treatment of dementia (age-related cognitive decline) and depression. In this document, the heating system has a miniature tip equipped with an induction microcoil for periodically heating the acupoint to a temperature between 44 and 50 degrees Celsius. The induction coil generates a magnetic field, which induces eddy currents in the conductive portion of the acupoint area. This document achieves magnetic induction heating where the dynamic magnetic field induces a loop current in a nearby conductor (in this case, the acupoint), thus the eddy currents short-circuit the conductor and heat it through magnetic induction heating. It does not lead to increased nitric oxide synthesis by increasing the production of any endothelial nitric oxide synthase.

[0006] The prior art document KR102427694B1 describes a method for treating stenosis using a pulsed magnetic field, describing the effect of the pulsed magnetic field on increasing blood flow. The pulsed magnetic field stimulation coil system uses an elliptical concentric coil with a cross-section of 12 cm wide and 4.5 cm long. Related literature provides a process for altering or increasing the velocity of red blood cells. It does not lead to increased nitric oxide synthesis by increasing the production of any endothelial nitric oxide synthase. The structure described in this document lacks the features of an applicator, a pulsed magnetic field that can operate without closure, and insensitivity to temperature and humidity.

[0007] The prior art document CN218280324U describes a pulsed magnetic field stimulator for treating post-stroke hand motor dysfunction. It discloses a magnetic probe and a pulsed magnetic field exciter, with a rotating disk within its internal cavity. A fixing base is located on the left side of the magnetic probe, rotatably connected to the top of the disk via a first rotating rod. The horizontal position of the magnetic probe is fixed, and the probe surface is placed against the patient's head. This solves the problem that current pulsed magnetic field stimulators typically require the doctor to hold the probe in place during practical use. However, the structure described in this document lacks an applicator, a pulsed magnetic field that can operate without closure, and features unaffected by temperature and humidity. Furthermore, it does not increase nitric oxide synthesis to treat or prevent disease by increasing the production of any endothelial nitric oxide synthase.

[0008] Existing technical document KR20210059345A describes a skin care device using pulsed magnetic fields and LEDs. Depending on the user's skin condition, it improves the user's skin by simultaneously irradiating the face, neck, and scalp with magnetic fields and LED beams, or selectively irradiating one of them. It aims to remove toxins from the skin, increase blood circulation and oxygenation efficiency, remove fat, and alleviate hair loss symptoms by using LED light and magnetic fields simultaneously. It does not increase nitric oxide synthesis to treat or prevent disease by increasing the production of any endothelial nitric oxide synthase.

[0009] In prior art document US2011263925A1, a pulsed magnetic therapy device is described. The purpose of the device described in the document is to provide a circuit that supplies current to an induction coil device placed at the operating end of a handheld device, with the aim of inducing a pulsed magnetic field through the 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 intended to treat or prevent disease by increasing nitric oxide synthesis through increasing the production of any endothelial nitric oxide synthase.

[0010] Existing technological solutions limit drug use because drugs that play a major role in coronary artery stenosis are undesirable in certain situations (e.g., bleeding, severe anemia, diseases that increase intracranial pressure, and high intraocular pressure), and also due to the lack of nitric oxide release, as nitric oxide is only produced and effective at the site of application, and similar systemic problems. In cases where carotid artery stenosis may occur, there is a lack of specific drugs or devices capable of delivering specific NO release to the lesion site, thus necessitating research and development in this area. Utility Model Content

[0011] The purpose of this utility model

[0012] The main objective of this invention is to provide a low-cost carotid artery vasodilator for use in cases of carotid artery obstruction and its prevention in the neck region. Positioned in the neck, it is configured to increase the production of nitric oxide mediated by endothelial nitric oxide synthase in the intact endothelial layer of the carotid artery, corresponding to the inner surface of a flexible neck brace. It incorporates a pulsed magnetic field (DMA) and does not cause pain stimulation.

[0013] The purpose of this invention is to produce a carotid artery vasodilator that is easy to carry, suitable for use by bedridden patients, can be fixed on the hospital bed, has a flexible neck brace that fits the shape of the neck, and has an adjustable bandage to ensure fixation during use.

[0014] Another objective of this invention is to produce a carotid artery vasodilator that facilitates vasodilation in the application area, increases the synthesis of tissue growth factors such as vascular endothelial growth factor, stimulates the formation of connective tissue through its vasodilatory effect, promotes wound healing and regeneration of damaged tissue, increases the number of myoblasts, and utilizes a pulsed magnetic field that exhibits anti-inflammatory effects.

[0015] Another objective of this invention is to produce a carotid artery dilation device. The magnetic field coil of this device is made of 200 turns of enameled wire with a diameter of 0.3 mm and has a size of 10 cm x 5 cm. It is used in a pulse magnetic field unit, and the field value generated by the coil under a 6-volt power supply is 0.5 mT.

[0016] Another objective of this invention is to allow the frequency value used by the device to be adjusted within the range of 0-2Hz and the power to be adjusted within the range of 0.1mT-1mT via the adjustment button on the device.

[0017] The purpose of this invention is to generate a pulsed magnetic field, wherein the DC power supply voltage of the inductive applicator that generates the magnetic field is in the form of a single-phase square wave, which can operate at 1Hz, with the DC power supply voltage switching on and off every second, i.e., a 50% duty cycle. Another purpose of this invention is to use a coaxial cable to prevent the device from generating additional noise in an electromagnetic environment and to prevent it from being affected by environmental noise when delivering energy to the applicator.

[0018] Another objective of this invention is to produce a carotid artery dilator whose operating range can be adjusted in 15-minute intervals and is unaffected by changes in ambient humidity and temperature, requiring no shutdown (under heavy load). One objective of this invention is to manufacture a carotid artery dilator that can operate without compromising EMC / EMI performance, generates no noise in the environment, is unaffected by environmental noise, does not alter its electrical parameters, and can deliver pulsed magnetic energy to the target point at a fixed frequency and constant amplitude with the target value. Attached Figure Description

[0019] Figure 1 Global view of carotid artery dilator

[0020] Figure Labels

[0021] 1. Control Unit

[0022] 2. Setting up the unit

[0023] 3. Power Supply Unit

[0024] 4. LCD screen

[0025] 5. Power cord

[0026] 6. Plug

[0027] 7. Applicator cable

[0028] 8. Straps

[0029] 9. Neck brace Detailed Implementation

[0030] The carotid artery vasodilator of this invention includes a control unit 1, a setting unit 2, which controls the pulsed magnetic field to a target value via a potentiometer on the control unit 1, an LCD screen 4, which allows monitoring and control of the settings, and a power supply unit 3, which can connect and disconnect the device. The power cord 5 of the device is preferably a shielded cable. For the carotid artery vasodilator of this invention, the applicator neck brace 9 receives energy through the applicator cable 7. The applicator cable 7 is preferably a coaxial cable. Electrical energy is obtained from a socket through a plug 6 at the end of the power cord 5. The applicator neck brace 9 is manufactured with a flexible structure and includes a strap 8 to ensure patient comfort and prevent the applicator from slipping. Figure 1 ).

[0031] Carotid artery dilators used to treat conditions such as carotid artery obstruction in the neck region include:

[0032] - A coil that can generate a pulsed magnetic field;

[0033] - Control unit 1 can control the magnetic field signal and set the parameters of the pulsed magnetic field applied to the neck region;

[0034] - Neck brace 9, by applying a local pulsed magnetic field, provides endothelial nitric oxide synthesis mediated by nitric oxide synthase in the intact endothelial layer of the carotid artery on the inner surface of the neck.

[0035] It also includes a 200-turn coil made of 0.3mm diameter enameled copper conductor, capable of generating a 0.5mT (millitas) pulsed magnetic field at a 6V power supply. It includes a coaxial applicator cable 7 that does not emit noise into the electromagnetic environment and ensures that energy is transferred to the control unit 1 and the neck brace 9 applicator unaffected by ambient noise. It also includes a shielded power cord 5 for providing a connection between the control unit 1 and the power supply. The control unit 1 includes at least one LCD screen 4 displaying parameters, a power supply unit 3 for starting or stopping the device, and a setting unit 2 that allows control of the generated pulsed magnetic field or changes in its intensity. It includes a neck brace 9, the outer surface of which is covered with a pillowcase, with an opening to fit the shape of the patient's neck. It has adjustable straps 8 for securing the neck brace 9 during use. It includes the setting unit 2, which allows setting the frequency value used by the device in the range of 0 to 2Hz and the power in the range of 0.1mT to 1mT (field strength). The applicator includes the coil that generates a pulsed magnetic field in the form of a single-phase square wave, causing the DC power supply voltage of the neck brace 9 to operate at 50% duty cycle of 1Hz, i.e., turning on for 1 second and turning off for 1 second.

[0036] The device provides a pulsed magnetic field that promotes vasodilation in its application area. It also increases the synthesis of tissue growth factors, such as vascular endothelial growth factor. It has analgesic effects in wound healing, damaged tissue regeneration, stimulating connective tissue formation through its vasodilatory action, increasing myoblast numbers, exhibiting anti-inflammatory effects, and increasing nitric oxide release. A low-cost magnetic carotid artery vasodilator (NECK-EM) that does not cause pain is provided. The device measures 40 x 30 x 15 cm, is portable, suitable for bedridden patients, and can be fixed to the bed. The neck brace 9 is designed to open to fit the shape of the neck, and its outer surface is covered with a pillowcase. This ensures the patient can comfortably continue treatment throughout the process.

[0037] The pulsed magnetic field device is fabricated to ensure that the magnetic field coil has 200 turns, made of enameled wire with a diameter of 0.3 mm, and measures 10 cm x 5 cm. It is known that the coil, as previously studied, produces a field value of 0.5 mT (millitas) at a 6 V power supply voltage. Preliminary studies indicate that this application has no negative impact on tissues. Therefore, it is suitable for routine use. Its dilating effect, due to its ability to increase nitric oxide production in blood vessels, helps to alleviate many symptoms in clinical applications. A 0.3 mm diameter copper conductor is used to generate the pulsed magnetic field. It is prepared by printing a circuit diagram onto a copper plate. A power cord 5, preferably a shielded cable, is used for connecting to the power supply. An adjustable strap 8 is used to secure the neck brace 9 when using the device. The device is switched on / off via a power unit 3 located on the control unit 1. The control unit 1 also includes an LCD screen 4 and a potentiometer-type setting unit 2. The main body of the device is made of a durable material—preferably a plastic-coated aluminum plate. Figure 1 ).

[0038] The magnetic carotid artery dilator is called NECK-EM. This device provides a uniform 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 setting unit 2 on the device, the frequency can be set in the range of 0-2 Hz, and the power in the range of 0.1 mT-1 mT. The applicator neck brace 9 is a detachable application component and an accessory to the device. It is inductive, and its coil has a suitable number of turns for the pulsed magnetic field. Therefore, a field with a vector perpendicular to the application area and a value of 0.5 mT (+ / - 10%) can be generated within the desired setting range. The inductive applicator neck brace 9 that generates the magnetic field operates on a 1 Hz DC power supply, switching on for 1 second and off for 1 second, i.e., a duty cycle of 50%. Therefore, under this intermittent power supply, the coil generating the magnetic field produces a pulsed magnetic field in the form of a single-phase square wave with a 50% duty cycle. The rise time of the pulse is negligible (less than 1 μs).

[0039] The device box transmits energy to the applicator neck 9 via the applicator cable 7 (preferably a coaxial or shielded cable). The design of the applicator cable 7 ensures that it does not generate additional noise in the electromagnetic environment and is unaffected by ambient noise. The device's operating interval is adjusted in 15-minute intervals. Furthermore, the device can operate without shutdown (under heavy load) and is unaffected by changes in ambient humidity and temperature. The device does not compromise EMC / EMI performance during operation, does not generate noise in the environment, is unaffected by ambient noise, and does not alter its set electrical parameters. The device delivers pulsed magnetic energy to the target point at a fixed frequency and constant amplitude, and at the target value.

Claims

1. A carotid artery vasodilator for treating carotid artery occlusion in the neck region, characterized in that, include: - A 200-turn coil made of 0.3 mm diameter enameled copper conductor capable of generating a pulsed magnetic field of 0.5 mT at a 6 V supply voltage. - Control unit (1), which allows control of the magnetic field signal and setting of the pulsed magnetic field parameters applied to the neck region, - Neck brace (9), which provides endothelial nitric oxide synthesis mediated by nitric oxide synthase in the intact endothelial layer of the carotid artery on the inner surface of the neck by applying a regional pulsed magnetic field.

2. The carotid artery vasodilator according to claim 1, characterized in that, Includes a coaxial applicator cable (7) that does not emit noise into the electromagnetic environment and ensures that it is unaffected by ambient noise when transmitting energy to the control unit (1) and neck brace (9) applicator.

3. The carotid artery vasodilator according to claim 1, characterized in that, Includes a shielded power cable (5), which provides a connection between the control unit (1) and the power supply.

4. The carotid artery vasodilator according to claim 1, characterized in that, The control unit (1) includes: - At least one LCD screen (4) that displays parameters. - A power supply unit (3) that enables the device to start or stop, and - Setting unit (2) that allows control or change of the intensity of the generated pulsed magnetic field.

5. The carotid artery vasodilator according to claim 1, characterized in that, Includes a neck brace (9), the outer surface of which is covered with a pillowcase and created by opening up an area that fits the shape of the patient's neck.

6. The carotid artery vasodilator according to claim 1, characterized in that, Includes an adjustable strap (8) that ensures the neck brace (9) is secured during use of the device.

7. The carotid artery vasodilator according to claim 4, characterized in that, The device includes the setting unit (2), which enables the frequency value used by the device to be set in the range of 0 to 2 Hz and the power to be set in the range of 0.1 mT to 1 mT.

8. The carotid artery vasodilator according to claim 1, characterized in that, The coil generates a pulsed magnetic field in the form of a single-phase square wave, enabling the DC power supply voltage of the applicator neck support (9) to operate at a frequency of 1 Hz and a duty cycle of 50%, i.e., 1 second on and 1 second off.

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