WO2024085833A1

WO2024085833A1 - A system for therapeutic transcranial direct current stimulati̇on using a footwear and application of this stimulation for daily treatment

Info

Publication number: WO2024085833A1
Application number: PCT/TR2023/050847
Authority: WO
Inventors: Güven AKÇAY; Çağla ÇELİK; İsmail ÖÇSOY
Original assignee: Hi̇ti̇t Üni̇versi̇tesi̇ Rektörlüğü; Erci̇yes Üni̇versi̇tesi̇ Strateji̇ Geli̇şti̇rme Dai̇re Başkanliği
Priority date: 2022-10-20
Filing date: 2023-08-23
Publication date: 2024-04-25

Abstract

The invention relates to a system that enables the use of electrical energy produced from mechanical energy during walking or sports activities of patients suffering from chronic pain without going to the hospital, in the treatment of the user during movement. Meet; It can be used in health fields such as medicine, biomedical engineering, physical therapy and rehabilitation.

Description

DESCRIPTION

A SYSTEM THAT CAN GENERATE THERAPEUTIC TRANSCRANIAL DIRECT CURRENT WITH A FOOT CLOTHING AND APPLICATION OF THERAPY IN DAILY LIFE WITH THIS CURRENT

TECHNICAL FIELD

The invention relates to a system that enables the use of electrical energy produced from mechanical energy during walking or sports activities of patients suffering from chronic pain without going to the hospital, in the treatment of the user during movement. Invention; It can be used in health fields such as medicine, biomedical engineering, physical therapy and rehabilitation.

BACKGROUND

Transcranial direct current stimulation (tDCS) applications are frequently used in the motor function treatment of neurological diseases such as cerebral stroke, traumatic spinal cord injury, and Parkinson's. tDCS is applied to the cerebral cortex by superficially applying constant and low-intensity current from the skull, and the direct current delivered from the active electrode placed in the skull reaches the reference electrode by passing through the brain tissue. In studies conducted with tDCS, mild itching, transient headache, weakness, and nausea were observed in the applied area in some people after tDCS treatment. Apart from these, no significant side effects were observed, and neuronal damage was not reported in safety studies.

In recent studies, it has been shown that tDCS acts by changing the membrane potential without generating action potential in neurons, without causing cell excitability and epileptic discharges. The degree of change in the brain is determined by the duration, polarity and direction of the applied direct current. The current passing through the brain tissue creates increasing or decreasing excitable effects in the cortical region. Excitability is determined by the intensity of the current and the polarity with anodal excitation or cathodal excitation. It is known that anodal tDCS application creates depolarization in neuron membranes with the activation of Na⁺-Ca²⁺ dependent channels in neurons and increases the excitability of cortical neurons, while cathodal tDCS application decreases the excitability of neurons.

Piezoelectricity is the electrical energy that emerges by applying a pressure force on the insulator (Piezoelectric crystals) material sandwiched between two opposite pole (+) and (-) conductive materials. The energy produced produces electricity in direct proportion to the strength of the externally applied mechanical energy.

In their study, Dagdeviren et al. designed a self-charging pacemaker with piezoelectricity, which is formed by the movement of internal organs (heartbeat or breathing) by sticking thin sheets on the heart, lungs and diaphragm. In this pacemaker, piezo electricity is used to convert the mechanical energy of the heart into electrical energy, allowing the pacemaker to charge itself. In this study, thin plates were placed on the heart, lungs and diaphragm and with the movement of internal organs (for example; heartbeat or breathing) these bending and twisting movements were provided to generate electronic power to the outside. Thus, the pacemaker was reactivated by using this electrical power of Piezo electricity.

In the prior art; There is no application that can reveal the technical effects created by our invention, which overlaps with the system described in our invention, that the electricity produced by piezos placed on a shoe sole is used for the treatment of the patient using the shoe (Transcranial direct current stimulation (tDCS)).

Hagedorn et al. (2012) used tDCS integrated into the EEG cap to change brain functions/activities. Auditory, visual, etc. of tDCS stimulation with this product. They examined changes in brain activity such as The patent we have presented includes the use of direct current we produce from piezo electricity in the treatment of neuropathic pain.

The use of electrical stimulation in the treatment of pain is used in the patent named “Spinal cord stimulation for chronic pain management” (Patent No.: US 7,333,857 B2). In this patent, electrical stimulation requires an invasive application on the suppression of pain by directly stimulating the spinothalamic pathway with spinal cord stimulation. In our invention, piezoelectric conversion of electrical energy is used. In addition, a non-invasive treatment method is created. Dagdeviren et al., in their study titled “Conformal piezoelectric systems for clinical and experimental characterization of soft tissue biomechanics” in 2015, produced conformal and piezoelectric devices that provide in-vivo measurements of soft tissue viscoelasticity in the epidermis. These systems provide harmonious contact with the complex topography and tissue underlying the targeted skin and other organ surfaces under both quasi-static and dynamic conditions. Experimental and theoretical characterization of the response of piezoelectric actuator-sensor pairs laminated on various soft biological tissues and organ systems in animal models provides information about the operation of the devices. Studies on human subjects demonstrate the clinical importance of these devices for rapid and non-invasive characterization of skin mechanical properties.

20% of the adult world population complains of neuropathic pain each year. Since chronic neuropathic pain causes movement and functional disorders in people, it also negatively affects the psychological and social life of the person. Today, antidepressants and anticonvulsants are used in the treatment of neuropathic pain. However, these drugs are often not at a level to inhibit pain. In this case, different drugs are tried by constantly changing drugs and drug toxicity can be seen in people. In recent years, neuromodulation non-invasive treatment methods such as transcranial direct current stimulation, which do not have any side effects/negative features, are frequently used for neurological diseases. Neuromodulation, which has started to be preferred as a treatment option in diseases such as stroke, epilepsy, and Parkinson's, is also in mind as a treatment option in neuropathic pain. The biggest advantages are that it has no side effects and is low cost. In addition, since it is simple to use, there is no need for the patient to come to the hospital if the person is taught. This significantly alleviates the hospital and doctor workload. In addition, the integration of the system with mobile devices is provided and the treatment protocol applied by the person is sent to the health institution to which he / she is connected, and it is aimed to inform him about the process.

Our invention is for the use of piezo electricity produced during walking and running in the treatment of diseases with neuropathic pain complaints. These patients do not have to go to the hospital to work, school, home, etc. In the environment, treatments are provided during walking or running. Thus, the workload of hospitals and doctors is also significantly reduced. In addition, the biggest advantages are that it has no side effects, is low cost and is very simple to use. The warning electrodes to be used in electrical stimulation are also placed inside a hat and the person is prevented from being exposed to social pressure by his environment. In addition, the integration of the system with mobile devices is provided and the treatment protocol applied by the person is sent to the health institution to which he / she is connected, and it is aimed to be informed about the process.

As a result of our movements in normal daily life, muscle activity produces mechanical energy. The energy generated when this mechanical energy is converted into electrical energy has the potential to be used in pain treatment in physical therapy with direct current stimulation. In our invention, mechanical energy has been converted into electrical energy by means of Piezo electricity and electrical stimulation has been obtained that can treat the person himself.

LIST OF FIGURES

Figure 1 . General Display of the System

Figure 2. Hat Internal Structure

The equivalents of the numbers given in the figures are:

1. Dynamo

2. Hat

2.1. Anodal Stimulation Electrode

2.2. Cathodal Stimulation Electrode

DETAILED DESCRIPTION OF THE INVENTION

The invention relates to a system that enables the use of electrical energy produced from mechanical energy during walking or sports activities of patients suffering from chronic pain without going to the hospital, in the treatment of the user during movement. The system is a shoe (1 ) containing a piezo element and a warning hat (2), which ensures that the electric current produced by this shoe (1 ) is applied to the user. The circuit is connected by mounting a Piezo element on the shoe (1 ) soleplate. Depending on the size of the sole of the shoe (1 ), more than one piezo element can be mounted. The amount of energy produced is directly proportional to the number of piezo elements. The piezo element is connected to each other with the help of cables on the sole of the shoe (1 ). Since the electricity produced will be alternating current, it is converted to direct current with a 1 N4007 Diode and a 5 volt AC-DC converter. This is because direct current is needed for treatment.

In the treatment of neuropathic pain, direct current stimulation is applied to the cortical area. In our invention, this stimulation is given to the surface by a disc electrode. Instead of placing the stimulating electrode (disc electrode) directly on the skull, the electrodes are mounted inside the hat (2). All electrodes are placed at regular intervals and each time the wearer wears the hat (2), so that they coincide exactly with the area of the skull where the current must be applied. The electrodes are fixed on the inner surface of the cap (2). The parts of the electrodes that should contact the skull are exposed on the inside of the hat (2). However, when viewed from the outside of the cap (2), there is no trace of it containing any electrodes. Thus, the user can continue his treatment in his daily life without being noticed by the people around him. The technical effect of our invention is at this point. The treatment environment mentioned in our invention is very different from the treatment of a patient in a hospital setting. As a matter of fact, it is a matter of carrying out a process and completing a treatment properly before it is understood that an individual who continues his daily life outside is being treated by other people. As a matter of fact, it is obvious that there will be a difference in terms of technical effect between a system that does not contain any elements of daily life and only generates current, and our invention. In addition, the presence of electrodes fixed in a cap (2) within the scope of our invention makes it possible to remove and reattach these electrodes by the user. Thanks to our invention, it is possible for the user to know this information, which cannot be obtained outside of doctors. Because our invention includes a slot on the inside of the cap (2) where each electrode will be attached. Therefore, when the user inserts the electrodes into these slots, the electrodes are also ideally placed so that the stimulation occurs ideally. The electrodes mounted in the said hat (2) are connected to the converter on the shoe (1 ) by means of cables. In this way, the electricity produced by the piezo elements is passed through the converter and brought to a form that can be applied and delivered to the electrodes. With the completion of the circuit, an average of 18.53 volts (5mA) and approximately 27.89 volts (11 mA) during running are produced by the piezo elements during the user's daily life with the shoes (1 ), and the current to be used in physical therapy is given to the person. The anodal stimulation electrode (2.1 ) is placed over the left or right primary motor cortex (M1 ) (opposite the pain area) and the cathodal stimulation electrode (2.2) is placed in the contralateral supraorbital area.

One of the main points in the invention, which we think is new and critical, is that the person produces the electrical energy necessary for his treatment, while continuing his daily life, by means of the piezo element in the shoe (1 ) while he is walking with the shoes. Apart from this, it is also important that it is low cost and very simple to use. In addition, the fact that the electrodes used in the treatment are not visible on the skull and are placed inside the hat (2) eliminates the pressure that the social environment may create on the person and adds a great value to the invention.

Apart from the features mentioned above, it is aimed to ensure the integration of the system with mobile devices, to send the treatment protocol applied by the person to the health institution and to inform the follow-up physician about the process. For this integration, a box (not shown in the Figures) is designed that can be attached to the wearer's clothing or belt, containing wireless communication protocols, a storage unit for storing data, and a microprocessor that manages information sharing. The cables coming out of the piezo elements in the shoe (1 ) were first connected to the input port of the box and sent to the cap (2) from the output port of the box. The input port transmits information to the processor to monitor the incoming current. Thus, the processor can detect that a current is generated from the piezo elements and that it is transmitted to the user from the output port. It records the duration of this flow in the storage unit as day, hour and application time. This recorded information is sent to the user's physician by connecting to the user's mobile device via wireless communication protocols. The connection with the mobile device is provided by a mobile application.

Claims

1 . A system that can produce therapeutic transcranial direct current with a foot clothing and apply this current in daily life characterized by comprising;

— Shoes (1 ) further comprising a piezo element that generates current on the sole,

— An inner surface containing warning electrodes at certain intervals and each time the wearer wears it, exactly coinciding with the area where the current should be applied to the skull, with the parts that should contact the skull exposed, and a hat (2) further comprising an outer surface that does not contain any traces when viewed from the outside, indicating that it contains any electrodes.

2. The system that can produce therapeutic transcranial direct current with a foot clothing according to claim 1 characterized by comprising wireless communication protocols positioned in a box that can be attached to the user's clothing or belt to ensure integration with mobile devices, a storage unit that provides data storage, and a microprocessor that manages information sharing.

3. The system that can produce therapeutic transcranial direct current with a foot clothing according to claim 2 characterized by comprising an input port where the cables coming out of the piezo elements in the shoe (1 ) are connected and an output port where the cables to be sent to the hat are connected.

4. The system that can produce therapeutic transcranial direct current with a foot clothing according to claim 2 or 3 characterized by comprising a microprocessor that detects that a current is generated from the piezo elements and that it is transferred to the user from the output port.

5. The system that can produce therapeutic transcranial direct current with a foot clothing according to any of the claims 2-4 characterized by comprising wireless communication protocols that send the current flow to the user's physician by connecting to the user's mobile device as day, hour and application time.