MODULAR ELECTRICAL MUSCLE STIMULATION ELECTRODE APPLIED TO THE ANKLE FOR USE IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH).

Abstract

The invention relates to a modular electrical muscle stimulation electrode (A) that provides comfortable and safe use to support muscle mass and muscle function, increase exercise capacity, improve circulation in the lower extremities, enable the release of various muscle myokines released during exercise as an alternative to exercise, and facilitate patient compliance in patients with PAH.

Description

1 TARIFF IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) MODULAR ANKLE-MOUNTED PAD FOR USE ELECTRICAL MUSCLE STIMULATION ELECTRODE 5 TECHNICAL FIELD The invention explores muscle mass and muscle loss in patients with PAH (Pulmonary Arterial Hypertension). to support function, increase exercise capacity, 10 in the lower extremities to improve circulation, various muscle secretions released during exercise as an alternative to exercise to induce the release of myokines, patients respond to electrical muscle stimulation Modular design that provides comfortable and secure use to facilitate adaptation. It involves electrical muscle stimulation with electrodes. PREVIOUS TECHNIQUE Current electrical muscle stimulation systems, especially in narrow areas like the ankle, Serious limitations in terms of use in mobile anatomical regions. This is observed. Most commercial EMS devices use 20-inch gel-based tablets with a flat and wide surface area. Equipped with adhesive pads; these pads can be applied to the abdominal, back, or major extremity muscles. It is designed for certain groups. When applied to areas such as the ankle, it requires... stimulation due to anatomical incompatibility or lack of stabilization Its effectiveness decreases significantly. It experiences displacement while in motion, inability to remain stable, and... Conditions such as decreased adhesion due to sweating prolong the treatment process by 25 It both divides the space and disrupts user comfort. However, with current electrodes, stimulation in a specific local area targets certain muscles. It can stimulate, but this does not constitute a complete exercise. Electrode placement, however... not by the user themselves, but by a specialist in the field (physiotherapist 30 (like this) because it has to be done regularly, it creates difficulties in regular use and This results in a decrease in the therapeutic effect. 2 Many errors are also observed in terms of hygiene and reuse. Gel-based pads, It loses its conductivity after a few uses; this can lead to bacterial growth and skin irritation. Dermatological risks arise. Most manufacturers ignore these problems. They are therefore insisting on low-cost adhesive solutions. Furthermore... Non-modular designs allow for the separation of components such as cables and connectors. 5 Because it doesn't provide these services, user-focused needs such as maintenance, cleaning, and transportation are overlooked. This greatly increases the system's usability in real life. It lowers it. In short, the shortcomings of the current systems are; anatomical incompatibility, 10 Lack of stabilization, risk of off-target stimulation, hygiene problems, and modularity. from fundamental engineering and user experience errors such as deficiencies This is the reason. Given these shortcomings, specific patients like PAH... customized, modular, ergonomic and targeted EMS systems for their groups The need is becoming increasingly apparent. 15 Electrical muscle stimulation (EMS) increases muscle mass by triggering muscle contraction. used to improve function, physiotherapy and sports rehabilitation It is a widely used technology in these fields. General characteristics of existing systems:  Adhesive surface electrodes (gel pads): Typically used on the abdomen, back, thighs, and arms. 20 It is applied to the muscles.  Mostly fixed connector designs: The electrodes are wired and the connector Part of it is fixed.  General purpose design: Not specific to an anatomical region; production cost Standard surface shapes are used to reduce the load. 25 Problems and Technical Issues Encountered in Practice Anatomical Incompatibility  Standard straight electrodes are not suitable for narrow and mobile anatomical areas such as the ankle. It is not physically compatible. 30  Because muscle groups are small and localized, stimulation may deviate from the target. 3  Stimulation effectiveness due to electrode displacement during movement. decreases. Fixing and Stability Problem  Gel-based adhesive pads provide protection against sweating, moisture, and prolonged use on the skin. It loses its adhesive properties.  When the user moves or continues with their daily activities Electrode detachment is common.  This disrupts treatment continuity and forces the user into a constant electrode position. It forces control. 10 Hygiene and Reuse Risks  Gel-based electrodes are not suitable for reuse; conductivity decreases over time. It falls.  There is a risk of bacterial growth on the electrode, especially on the outer surface such as the ankle. In areas exposed to various factors. • Dermatological problems such as skin irritation, redness, and irritation are common. Lack of Modularity and Usability Difficulties  Designs with fixed connectors reduce the user's risk during transport and cleaning. It's difficult.  Structures with non-detachable cables increase the risk of breakage and wear.  Module replacement or different electrodes depending on the application scenario. It is not possible to use this combination. Low Clinical Efficacy  Stimulation to a level that will cause the release of muscle myokines If this cannot be done, the system will be deprived of the exercise alternative.  Since physical capacity is low in PAH patients, muscle stimulation It should be an alternative to exercise, but current systems have 30 players aiming for this goal. There are no algorithms. 4 Negative aspects stemming from user experience.  Inability to integrate into daily life: The systems are generally not suitable for clinical settings. Because it's designed to work, it's difficult to use comfortably at home.  Aesthetic problems: Discomfort from large adhesive electrodes on the ankle. creates; visibility under clothing and an inconvenient cable structure for user 5 This leads to rejection.  Application difficulty: Electrode placement in elderly individuals and those with limited physical mobility. placing it in the correct location, securing it, and ensuring the cable connections are secured. It can be difficult in practice. Consequently, due to the aforementioned drawbacks and shortcomings, the relevant The need for an innovation in the technical field has arisen. THE PURPOSE OF THE INVENTION The overall purpose of the invention is to create a complete system that meets the requirements mentioned above. Especially PAHs, which eliminate disadvantages and bring some additional advantages. In patients with Pulmonary Arterial Hypertension; muscle mass and muscle function decrease by 5 to support, increase exercise capacity, improve circulation in the lower extremities to improve, various muscle secretions released during exercise as an alternative to exercise to stimulate myokine secretion, to facilitate patient compliance, and to make them comfortable with modular electrical muscle stimulation electrodes that ensure safe use It is related. 10 Due to the drawbacks of the previous technique, the invention, as described above, It aims to resolve the negative aspects. Other important purposes of the invention: 15 Ensuring a Specific Anatomical Fit for the Ankle  Since current electrodes are designed for large muscle groups, ankle It does not adapt well to the narrow and busy areas around it.  This invention allows the electrode surface and fixation system to be adapted to the anatomy of the ankle. It aims to be specially designed. Thus, the device, during application... It is unaffected by minor movements and provides uninterrupted support to the target muscle group. It provides stimulation. Increased Efficiency Through Targeted Muscle Stimulation 25  The electrode configuration will stimulate only the specified small muscle groups. By positioning it in this way, multiple muscle contractions are prevented.  Especially considering the low exercise capacity in PAH patients, Our invention works by being attached to both ankles and simultaneously to both legs. Because it stimulates all your muscles synchronously, it provides effective and controlled stimulation, vital 30 It is important. 6 Triggering Muscle Myokine Release Through an Alternative Method to Exercise  Myokines released from muscles during exercise (e.g., IL-6, irisin, Follistatin-like protein 1 (FSTL1) is a chemokine family ligand protein 1. (CXCL1), Insulin-like growth factor 1 (IGF-1) circulation, metabolism and it has a positive effect on the immune system. 5  The invention stimulates muscle contraction to a biologically effective level. It stimulates secretions and has a therapeutic effect without the need for exercise. It aims to provide. Modularity for Ease of Cleaning, Maintenance and Application 10  The connectors are removable; this allows the electrodes to be cleaned individually, It allows for easy portability and customizability according to the user's needs.  This modular structure allows for adaptation to different patient types and component replacement. and simplifies maintenance operations. Improving Patient Compliance and User Comfort • Skin-friendly, ergonomic and aesthetically pleasing alternatives to uncomfortable fastening structures. Patient compliance is increased through a design that does not cause discomfort.  Staying compatible with movement in active areas such as the ankle, providing the user with therapeutic benefits. It provides comfort throughout. 20 To ensure hygienic and long-lasting use.  Unlike gel-based electrodes, it maintains its conductivity and does not harm the skin. Long-term use and hygiene thanks to reusable materials. standards are met. 25  This feature is especially designed for individual use in a home environment. It is important in applications. Offering a Personalized Stimulation System for Home Use  Instead of fixed algorithms; 30 such as waveform, frequency and excitation duration It aims to allow parameters to be adjusted in a user-specific manner. 7  PAH patients can manage their condition at home without the support of a healthcare professional. A system is developed that he / she can use. To fulfill all the purposes stated above and those that can be derived from the detailed explanation. The invention aims to bring about; 5 in patients with pulmonary arterial hypertension (PAH). Modular electrical muscle stimulation applied to the ankle for use It is related to the electrode. 8 DESCRIPTION OF THE FIGURES Figure 1; Perspective of the modular electrical muscle stimulation electrode, the subject of the invention. The application view is available. REFERENCE NUMBERS A. Electrode 10. Conductive carbon sheet 10 20. Adhesive tape 30. Female pin cable 40. Fabric sheet 50. Velcro 9 DETAILED DESCRIPTION OF THE INVENTION The overall purpose of the invention is to create a complete system that meets the requirements mentioned above. Especially PAHs, which eliminate disadvantages and bring some additional advantages. In patients with Pulmonary Arterial Hypertension; muscle mass and muscle function decrease by 5 to support, increase exercise capacity, improve circulation in the lower extremities to improve, various muscle secretions released during exercise as an alternative to exercise to stimulate myokine secretion, to facilitate patient compliance, and to make them comfortable with modular electrical muscle stimulation electrodes that ensure safe use It is related. 10 Due to the drawbacks of the previous technique, the invention, as described above, It aims to resolve the negative aspects. Figure 1 shows the perspective of the modular electrical muscle stimulation electrode, which is the subject of the invention. The application view is available. The invention aims to support muscle mass and muscle function, and promote exercise in patients with PAH. to increase capacity, improve circulation in the lower extremities, alternative to exercise to stimulate the release of various muscle myokines released during exercise, 20 Modular design that provides comfortable and safe use to facilitate patient compliance. The electrical muscle stimulation electrode (A) has the following features: — thanks to its conductive structure that comes into direct contact with the skin, it connects to the muscle. carbon conductor 25 that enables the stimulation to be carried out sheet layer (10), — located under the carbon conductive plate layer (10), electrical carbon conductor that allows signals to propagate across the contact surface sheet layer (10), — carbon conductive sheet (10), adhesive tape (20) and protective 30 tape that holds the fabric sheet (40) together (20), — preservation of the integrity of the electrode (A) elements, environmental provides protection against external factors and offers electrical insulation. fabric sheet made of medical textile material with special properties (40) is characterized by its inclusion. Modular electrical muscle stimulation electrode (A): — ensuring that the electrode (A) is fixed / attached to the ankle, It includes a velcro structure mechanism (50) compatible with different diameters, — communication with the external EMS device, connected to the carbon plate (10). It includes a female pin connector that enables its installation, — carbon plate (10); providing large surface excitation and energy It is produced from carbon graphite-based material, which increases efficiency, 15 — the band (20); which is elastic in structure and maintains the alignment of the layers, providing medical support to prevent slipping, — fabric layer (40); having antibacterial properties, medical 20 Made of textile, protective and insulating against external factors. having the feature, Electrode (A) is a modular device designed for application to the ankle region. It is an electrical muscle stimulation electrode. It includes the following subcomponents: 25 Carbon Sheet (10)  By enabling the electrical stimulus to spread over a large surface area, it targets the muscle group. It affects everything.  Its carbon-based structure offers high conductivity and long service life. 30  Improves electrode performance and energy efficiency. 11 Adhesive tape (20)  A stabilizer used to hold the gel, carbon, and fabric layers together. It is a component.  Its anti-slip design maintains the alignment of the electrode components.  It also provides structural stability against external pressure. 5 Fabric Sheet (40)  It is the protective layer that forms the outer surface of the electrode.  Made from soft medical textile material; skin-friendly and anti- It is allergenic. 10  Thanks to its insulating properties, it prevents electrical leaks and damage caused by external factors. It prevents deterioration.  It also contributes to the design in terms of aesthetics and user comfort. Velcro tape (Device) (50) 15  This is the structure that secures the electrode to the ankle.  It has a flexible structure that adapts to different diameters.  Quick and easy to put on and take off with the Velcro mechanism; patient compliance and ease of use. It provides usability.  During fixation, ensure it remains compatible with ankle movements for 20 seconds. It is ergonomically positioned. Female Pin Attached to Conductive Plate (30)  Integrated into the carbon plate and providing connection with the external EMS device. It is a standard female connector. 25  It offers the user compatible and modular connectivity options with the device.  Its easy-to-install and detach design enhances the system's portability and maintenance. It supports ease of use.  Increased compatibility with different EMS devices, making switching between devices easier. It provides. 30 The Production Process of the Invention 12 The modular electrical muscle stimulation electrode (Electrode A) consists of different layers and It consists of interconnectable components. Therefore, the production process is multi-layered. This requires a technical approach: Material Selection  Carbon sheet (10): Cut from thin film carbon graphite material, surface 5 Its conductivity has been optimized.  Adhesive tape (20): Elastic textile backing with medical adhesive. stabilizing material.  Female pin connector (30): 2-3 mm female socket compatible with EMS devices, 10 with conductive integration using carbon sheet  Fabric layer (40): Insulating, antibacterial medical textile.  Velcro layer-Mechanism (50): Made of PU or neoprene-based elastic fabric Velcro systems are manufactured to fit various diameters. Layered Assembly Stages 15 1. Sewing the Velcro tape (50) system to the outer fabric base (40). 2. Double-sided non-slip adhesive tape (20) to the fabric sheet (40) gluing 3. Attaching the female pin connector (30) to the adhesive tape (20) 4. Carbon conductive sheet (10) adhesive tape (20) and female connector (30) 20 gluing 5. The product undergoes sterilization and quality control tests (conductivity, (fixation strength, skin compatibility). Application / Use Process of the Invention 25 The application process is optimized for both clinical and home use: Preparation  The electrode's connecting cable is plugged into the EMS device.  Skin cleansing is ensured, especially the removal of oil and dirt buildup in the ankle area. It is resolved. 30  The electrode (A) is placed on the wrist, the tightness of the device (50) is adjusted with Velcro. 13 Use Case Study  Electrical stimulation from the device; transferred from the carbon plate to the gel layer. It is transmitted.  Stimulation parameters (frequency, waveform, duration) of PAH patients' muscles It is adjusted according to its tolerance. 5  Can be applied during exercise or at rest (especially mobile) (as an exercise alternative for patients without the necessary qualifications). Duration and Frequency  1-2 sessions per day, each session lasting approximately 20-30 minutes, can be planned. 10  Adjustments based on physical development and the patient's level of muscle response. It can be done. Working Principle of the Invention The electrode works by providing targeted muscle stimulation, resulting in biological and 15... It is aimed at producing a physiological effect: Electrical Transmission  Electrical signal from the EMS device → female pin → carbon plate → skin → eyebrow.  This current stimulates motor neurons, triggering muscle contraction. 20 Targeted Muscle Stimulation  The electrode's shape stimulates nerve and muscle groups around the ankle. It creates.  Simultaneous contraction of both lower extremities leads to myokine release and increased circulation. 25 Recovery and increased muscle function are supported. Biological Effect  Muscle activation is achieved without the need for exercise.  Myokines (e.g., Follistatin-like protein 1 (FSTL1), chemokine family 30 Release of ligand protein 1 (CXCL1) and insulin-like growth factor 1 (IGF-1); 14 positive effects on metabolic balance, inflammation control and systemic circulation. It creates effects. This invention involves electrical muscle stimulation applied by wrapping a band around the ankle. A special 5 that provides (EMS), with a multi-layered and modular connection system. It is an electrode. Basic Working Mechanism: 1-Transmission of Electrical Stimulus: The conductive carbon film located inside the electrode. The low-voltage electrical current from the EMS device is safely passed through the skin's surface. In this way, it transmits it to the muscles of the lower extremities. 2-Muscle Stimulation: By stimulating motor neurons under the skin, the target muscle is targeted. ankle ligaments (especially tibialis anterior, soleus, gastrocnemius) (surrounding muscles) contraction and relaxation cycles are formed. Also, sensory neurons 15 via a reflex motor response through the relevant spinal cord segment, also affecting the muscle. It causes muscle contractions. 3-Device Integration: The product is compatible with standard 2 mm male pin-ended EMS / TENS devices. It has a modular connection socket compatible with various EMS devices. This allows it to be used with 20 different EMS devices. Availability is ensured. 4-Anatomical Adaptation and Fixation: The electrode conforms to the anatomical shape surrounding the ankle. Properly designed and features a Velcro fastening system on the outer layer. This structure allows the electrode to make full contact with the desired area, 25 It enables the efficient transmission of electric current. 5-Insulation and Safety: The outer layer is covered with insulating and skin-friendly medical fabric. This structure both cuts off electrical contact with the outside environment and enhances user comfort. increases. 30 The Basis of the Principle: The basic function of EMS devices is to transmit externally applied electrical signals. Increasing muscle tone by mimicking muscle function with impulses reduces the risk of atrophy. to reduce exercise-induced myokine release and improve circulation The aim is to support this. This electrode applies this technology to a customized anatomical region (foot). (by targeting the wrist) to deliver it in a portable, repeatable and safe way. 5 It aims to... This invention, unlike classic pad-type surface electrodes, provides muscle stimulation. localized to the ankle, providing a stable and secure fit, and also It is an electrode system that can work with many EMS devices via modular connection. 10 Target Audience of the Invention Patients with Pulmonary Arterial Hypertension (PAH): Those with poor exercise tolerance, Individuals at risk of muscle loss. Muscle loss during clinical follow-up or home treatment. 15 Patients who need stimulation. Individuals with Chronic Diseases: Chronic obstructive pulmonary disease (COPD), heart disease those who want to preserve mobility in conditions such as disability, neurological disorders individuals. 20 Elderly and Bedridden Individuals: Regular EMS to prevent muscle atrophy. Elderly individuals who need support. Physical Therapy and Rehabilitation Patients: Lower extremity muscle rehabilitation 25 Patients who require EMS support during the process. Athletes in the Rehabilitation Process After Sports Injuries: Ankle Athletes who need targeted training of surrounding muscle groups. Corporate and Commercial Clients: Hospitals and University Research Hospitals, Cardiopulmonary rehabilitation units, Physiotherapy and rehabilitation departments, 16 Physical Therapy Centers and Rehabilitation Clinic Chains, EMS-based therapy centers offering programs, Home Health and Home Care Services Organizations, institutions that support home treatment processes for elderly and chronically ill patients, Medical device and orthopedic product distributors, EMS device manufacturers and sellers. Companies in need of next-generation accessories that can work in an integrated manner, Medical Textiles and 5 Wearable technology developers can partner with potential partners for product development and mass production. textile manufacturers. Individual Customers (End Users): Individuals who own their own EMS device and whose feet are on the ground. Individuals who wish to use custom electrodes on their wrists can purchase medical products online at 10. users of the platforms, patients continuing their physical therapy process at home, and relatives To fulfill all the purposes stated above and those that can be derived from the detailed explanation. The invention aims to bring about; in patients with pulmonary arterial hypertension (PAH) 15 Modular electrical muscle stimulation applied to the ankle for use It is related to the electrode.

Claims

17 REQUESTS 1. The invention aims to support muscle mass and muscle function in patients with PAH. to increase exercise capacity, improve circulation in the lower extremities, 5 various muscle myokines released during exercise as an alternative to exercise to facilitate secretion, comfortable and safe to make patient compliance easier Modular electrical muscle stimulation electrode (A) providing one use Its characteristic is; — thanks to its conductive structure that comes into direct contact with the skin, it reaches the muscle 10 conductive carbon that enables stimulation to be carried out layer (10), — Carbon sheet (10), female pin connector (30) and protective fabric tape (20) which keeps the layer (40) together / in place, — preservation of the integrity of the electrode (A) elements, environmental 15 provides protection against external factors and offers electrical insulation. fabric sheet made of medical textile material with special properties (40) is characterized by its inclusion.

2. Modular electrical muscle stimulation electrode (A) conforming to claim 1, 20 feature; — ensuring that the electrode (A) is fixed / attached to the ankle, It is characterized by containing Velcro straps (50) compatible with different diameters. is being done. 25 3. Modular electrical muscle stimulation electrode (A) conforming to claim 1, feature; 18 — communication with the external EMS device, connected to the carbon plate (10). It is characterized by containing a female pin connector that enables its installation. is being done.

4. Modular electrical muscle stimulation electrode (A) conforming to claim 1, 5 feature; — carbon plate (10); providing large surface excitation and energy by being produced from carbon graphite-based material that increases efficiency It is characterized. 10 5. Modular electrical muscle stimulation electrode (A) conforming to claim 1, feature; — adhesive tape (20); being elastic in nature and aligning the layers 15 by providing protective, slip-resistant medical support It is characterized by...

6. Modular electrical muscle stimulation electrode (A) conforming to claim 1, Feature; 20 — fabric layer (40); having antibacterial properties, medical Made of textile, protective and insulating against external factors. It is characterized by having this feature.

Images