EAR ELECTRODE FOR CUSTOMIZABLE VAGUS NERVE STIMULATION THAT ADAPTS TO VARYING EAR ANATOMY.

Abstract

The invention relates to a modular ear electrode device suitable for different ear anatomies, used in the medical field, particularly in vagus nerve stimulation therapy.

Description

1 TARIFF ADAPTED TO VARYING EAR ANATOMY EAR FOR PERSONALIZED VAGUS NERVE STIMULATION. ELECTRODE Technical Field to Which the Invention Relates 5 The technical field to which the invention relates is medical devices and neuromodulation technologies, in particular. It is related to the auricular vagus nerve stimulation device. Prior knowledge of the art related to the invention. The parasympathetic nervous system controls all of the body's vital functions. It is part of the autonomic nervous system. The vagus nerve is the main component of the parasympathetic nervous system. Nerves affect many vital processes, from heart rate and digestion to the immune system and mood. It controls [the vagus nerve]. Healthy vagus nerve function is critically important for overall health. Numerous health problems can arise from nerve dysfunction. Today, 15 drugs are used in the treatment of many neurological and psychiatric disorders such as epilepsy and depression. Vagus nerve stimulation (VNS), also known as vagus nerve stimulation, has been proven effective many times. A proven treatment method is being applied. VNS treatment also involves surgical (invasive) intervention on the patient's body, Non-invasive methods are generally preferred as a more practical approach. Non-invasive In this method, a low-voltage electrical current is applied to stimulate the vagus nerve in the patient's neck or ear areas. Currents are sent. This type of stimulation performed through the ear is called auricular vagus nerve stimulation. (taVNS) is the name given to this. Hospitals, clinics, and healthcare facilities use it for ease of treatment application. Centers, therapists, and individual users all prefer auricular vagus nerve stimulation. In this field, developing health technologies, neurological treatment devices, and personalized health solutions The preferred methods are as follows: 25 Single-area stimulation electrodes: In this method, the available electrodes are generally By selecting either the tragus structure or the concha region in the ear, from only one point... It provides stimulation. However, since the vagus nerve is known to be located in both areas, This approach can reduce treatment effectiveness. The main reason for this is that ear structure varies from person to person. It varies greatly from person to person and can adapt to both tragus and concha regions. The difficulty lies in designing an electrode that focuses on a single region. Therefore, manufacturers tend to design electrodes that concentrate on a single area. They prefer to use electrodes. These electrodes are usually used to stimulate these areas. 2 Clip electrodes are preferred. These types of electrodes are attached to the ear like a clothespin. Because they hold on so tightly, they can be painful. Users are uncomfortable with this situation and They may choose not to continue the treatment. Minimally invasive electrodes: Minimally invasive devices designed to provide more effective stimulation. Electrodes can also be used. Using minimally invasive methods, electrodes are placed in the ear. It can be fixed to different areas, allowing for more effective vagus nerve stimulation. It is possible to achieve this. However, this method requires an invasive procedure and is problematic for users. It can be uncomfortable. The procedure can be painful and the user's skin integrity is compromised. Furthermore, minimally invasive methods are often costly, and the insertion and removal of electrodes is complicated. A doctor's intervention is needed for this. Minimally invasive methods, non-invasive 10 Compared to solutions, it is more risky and troublesome. Fixed-size non-invasive electrodes: The electrodes used in this method are fixed-size. Because of this, it may not be a perfect fit for every user. Sometimes it sounds small. It cannot remain stable, and sometimes it is large and causes discomfort. This condition requires treatment. disrupting the process and causing users to drop the device or experience pain while using it. 15 This is the reason. Furthermore, this incompatibility leads to inadequate treatment for the user. It can lead to stress and anxiety. Consequently, current solutions in this area either only stimulate a single region. either requires a minimally invasive procedure or a fixed implant that may not be suitable for every user. It includes designs that are limited in scope. All these limitations reduce treatment effectiveness and user 20 It negatively affects their comfort. Purposes and Brief Description of the Invention The main purpose of the invention is to treat both tragus nerves in the ear with auricular vagus nerve stimulation (VNS). and can provide simultaneous stimulation via the concha regions, according to different ear anatomies. The goal is to develop an adjustable and customizable ear electrode. The existing ear 25 Because the electrodes are of a fixed size, they can be adapted to different ear structures of users. This is not possible, which can cause the electrodes to fall out of the ear, resulting in discomfort for the user. This results in either insufficient nerve stimulation or the creation of a false positive. The present invention, depending on the ear structure... It features an adjustable mechanism, making it suitable for users with different ear anatomy. 3 It solves this problem by providing a design that fits perfectly in the ear. It provides comfort to the user and contributes positively to the treatment. Previous ear electrode systems only stimulated the tragus or concha region. This is done because vagus nerve fibers are found in both regions of the ear, therefore, from both regions... Simultaneous stimulation increases treatment effectiveness. The current invention stimulates both the tragus and the 5th by simultaneously contacting the turbinate regions, it stimulates the vagus nerve fibers, thereby... The aim is to increase the effectiveness of the treatment. In previous ear electrode systems, electrodes were attached using clip or adhesive mechanisms. It is fixed to the ear using [method]. This situation causes problems for users during long-term use. It creates discomfort and inconvenience. The present invention is a device that stretches outwards and allows the user to 10 It features a mechanism that can be adjusted to fit the ear shape, providing a more comfortable wearing experience. It provides and enables the continuation of treatment. Furthermore, since the current invention offers a non-surgical solution, it requires minimally invasive intervention. It eliminates various health risks compared to other ear electrode systems that require them. It aims to be a safe and easy-to-use solution. 15 Definitions of the Figures Illustrating the Invention The diagrams and related information used to better explain the device developed with this invention are as follows: The explanations are below. Figure 1. Vertical cross-sectional view of the ear electrode. Figure 2. Pre-use appearance of the ear electrode. 20 Figure 3. Stretched view of the ear electrode during use. Figure 4. Open view of all elements of the ear electrode. Figure 5. Disassembled view of the left probe and left support piece of the ear electrode. Figure 6. Posterior view of the ear electrode. Descriptions of the Elements / Parts / Components Constituting the Invention 25 To better explain the device developed with this invention, the parts and figures are shown in the diagrams. The sections are numbered, and the corresponding information for each number is given below. Ear Electrode 1. Electrode Tip 4 10. Stimulation Probe 10a. Probe Connector 11. Probe Support 11a. Support Connector Socket 11b. Probe Housing 5 11c. Transmission Socket 2. Electrode Connector 2a. Connecting Arm 2b. Connection Center 3. Signal Transmission Part 10 Detailed Description of the Invention Referring to Figure 1; it includes a cross-sectional view of the anterior surface plane of the ear electrode (K). Electrode connection piece (2) right and left probe (10), right and left probe supports (11) together It holds. The electrode connection piece (2) here preferably has an O-ring-like geometry. It has. 15 Referring to Figure 2; it includes the closed view of the ear electrode (K) before use. The electrode connector (2) is flexible enough to hold all the parts on the ear together. Its structure allows it to be compressed and the parts to be brought closer together. This structure enables it to be worn over the ear and... Removal becomes easier, providing convenience. Referring to Figure 3; it includes the stretched view of the ear electrode (K) during use. 20 The flexible structure of the electrode connection piece (2) allows the right and left probes (10) to be used during operation. by pushing the support pieces (11) in the opposite direction of the compression, the probes (10) in the tragus of the ear and ensures contact with the turbinate regions. In addition, this pushing motion makes contact with the ear electrode (K). By helping it stay in a stable position over the ear canal, it prevents falls or It prevents spontaneous eruption, thus contributing to the continuity of treatment. 25 Referring to Figure 4; it includes an unfolded view of all elements of the ear electrode (K). Ear Right probe (10), left probe (10), right probe support (11), left probe support (11) on electrode (K) and electrode connector (2) are arranged symmetrically on the same horizontal axis. The symmetrical structure allows the ear electrode (K) to be used in either the right or left ear. This provides convenience to the user, positively influencing their outlook on treatment. It has an effect. Referring to Figure 5; disassembly of the left probe (10) and left support piece (11) of the ear electrode 5 It includes the appearance. The connection structure located on the support piece (11) is preferably the electrode. a suitable gap between the ends of the connecting piece (2), probe (10) and electrode connecting piece (2) to stay together and to be protected from external factors in the transmission of the signal to the probe (10) for nerve stimulation. It provides protection against. Here the probe support piece (11) provides both these features, at the same time. In order to create a comfortable treatment process for the user, preferably from a plastic material, 10 It has been manufactured. Similarly, electrode probes (10) transmit stimulation signals close to the vagus nerve. It is made of conductive material, preferably metal, to transmit signals to the tragus and concha nerves. Referring to Figure 6; it includes a posterior view of the ear electrode (K). The posterior view shows the ear. This is the outward appearance of the electrode (K) when it is attached to the user. In the view, the electrode The connection of the connecting piece (2) to the right and left probe supports (11) and also 15 the transmission part (3) which enables signal transmission, preferably a cable, probe supports (11) Access to the electrode probes (10) is shown. For customizable vagus nerve stimulation to accommodate varying ear anatomy. The designed ear electrode (K) is placed on the tragus and concha regions of the auricle. element 20 of a flexible electrode connector (2) between contacting metal probes (10). The most important difference is the use of a ring. Here, the electrode connection is round, preferably O-ring-like. It has a structure and this geometry allows it to be compressed by two opposing forces on the same axis, and the force Afterwards, it stretches and returns to its original appearance. The anatomy of the human ear. Because it varies greatly from person to person, electrode connectors come in a single size. It is not possible to meet these differences with (2). Therefore, there are 25 different ear electrodes (K). Replaceable electrode connectors with varying dimensions are used. Users can insert them into the ear. Select the electrode connection of different sizes that best suits the structure and the whole ear electrode (K) It can easily assemble its parts. When inserting the ear electrode (K) into the ear, the user should direct the electrode probes (10) in two opposite directions. By pressing firmly, compress the electrode connector (2) inwards. Insert the ear electrode (K) 30 Place the electrode connection piece (2) over the cavity in the auricle, tragus and concha 6 by stretching according to the distance between them and out of the direction of squeezing the electrode probes (10). By pushing, it adapts perfectly to the user's ear. This stretching movement involves the tragus and concha. Automatic adjustment of the probes (10) according to the distance between them and their equivalent regions. It provides timely contact. In addition, the replaceable electrode connector (2) ensures contact with the ear. The electrode (K) can be customized to users by perfectly fitting all types of ear structures. 5 It can also offer an experience. This mechanism allows metal probes to fit snugly into the ear. It helps create a comfortable and effective connection.

Claims

7 REQUESTS 1. An ear electrode (K) capable of stimulating the auricular vagus nerve, its feature is; - Provides nerve stimulation to two separate areas on the ear and electrode tips (1) found stimulation probes (10); - Keep the stimulation probes (10) fixed in their positions in the ear with the probe holder (11b) on them. enabling it to stop, at least one connection socket (11a) and the transmitted signal to the probes (10) probe supports (11) containing at least one transmission slot (11c) allowing passage; - The element (K) in the ear electrode that holds all the components together when force is applied to it. allowing the electrode tips (1) to come closer together when the force is removed. an electrode connector (2) that separates them; 10 - Signal transmission part (3) to probes (10) that triggers nerve stimulation It includes.

2. It is an equipment conforming to Claim 1, and its feature is a spring as an electrode connection piece (2). It includes the element 15.

3. It is equipment that complies with claim 2, and its feature is that the mentioned electrode connection piece (2) It has a flexible structure.

4. The equipment complies with claims 2 and 3, and its characteristic is that the aforementioned electrode connector is 20 (2) is that it contains a ring-shaped connection center (2b).

5. It is equipment that complies with Claim 1, and its feature is that the ear electrode (K) is in different ears. The connection on the probe supports (11) to ensure compatibility with their anatomy Electrode connector with removable connecting arms (2a) that can be attached to and detached from its sockets (11a) 25 (2) is included.

6. It is equipment that complies with Claim 1, and its feature is that the ear electrode (K) is in different ears. Multiple different sizes of electrode connectors to ensure a fit according to their anatomy. It contains part (2). 30 8 7. The equipment complies with Claim 1 and its characteristic is that it is configured as a cable. It contains the signal transmission part (3).

8. The equipment complies with Claim 1 and is configured as a wireless transmission device. The mentioned signal transmission part (3) is included. 5 10

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