Neuromodulation device for functional rehabilitation and pain treatment and stimulation / control system for functional rehabilitation and pain treatment

Abstract

To provide a neuromodulation device for functional rehabilitation treatment and pain treatment.SOLUTION: A neuromodulation device 100 for functional rehabilitation and pain treatment includes a housing body and a housing cover. In the housing body, at least one electronic plate is arranged, which configures the neuromodulation device 100 for functional rehabilitation and pain treatment. The electronic plate is provided with: at least one control plate provided with at least one microcontroller for adjustment function control; at least one actuator plate provided with at least one converter and an H bridge; and at least one Wi-Fi module for connecting at least one sensor to transmit data to an artificial intelligence module 201 and at least one server 202.SELECTED DRAWING: Figure 25

Description

Technical Field

[0001] The present invention particularly relates to a neuromodulation device used for functional rehabilitation treatment and pain treatment of patients by non-invasively or externally applying electrical stimulation, and a stimulation / control system for functional rehabilitation treatment and pain treatment. This system uses a neuromodulation device in combination with a control subsystem to non-invasively apply electrical stimulation so that patients can recover movement and regulate pain.

Background Art

[0002] Neuromodulation is a series of medical techniques that can cause a physical reaction in a person by imparting physical characteristics provided by a device or apparatus when combined with neuroscience technology.

[0003] Generally, neuromodulation is used to treat patients with neurogenic visceral pain with functional disorders or injuries in nerve cells of the peripheral nervous system or central nervous system by invasive or non-invasive methods.

[0004] In this context, at least one neural stimulator or neuromodulation device is used, including electronic components and electronic circuits that can cooperate to modulate current, voltage, and specific frequencies so as to affect the neural activity of the user's nerve cells by electrical or chemical stimulation.

[0005] The current is modulated and applied to the patient's nerve cells and specific nerves, enabling the generation of nerve impulses in the patient's body in a non-voluntary manner. The nerve impulses can be generated for reactions that are either favorable or unfavorable to the patient. Thus, neuromodulation works in collaboration with the brain to decode the stimulus into a nerve response and transmit the desired current for the application of neuromodulation, thereby restoring nerve balance and assisting in improving the function of the patient's nervous system.

[0006] Such an application of the modulated current may be directly applied to the origin of unwanted nerve impulses, such as at the site where chronic pain is felt, or it can also be applied to a substantial spatial region of the patient's body from the sensory point of local nerve activity. In this way, the modulated current adjusts nerve activity for the purpose of treating neurological, psychiatric, and other pathological symptoms such as Parkinson's disease, chronic pain, depression, and epilepsy.

[0007] To generate the state of the current by a neuromodulation device, the presence of a periodic transmission frequency is required, which can be either low or high. The operating range of the operating frequency directly affects the nerves and neural stimulation. Therefore, the result is one of the system-wide variables that must be managed / administered in functional therapy.

[0008] The neuromodulation device can pass an electric current through the patient's body as an output signal, but the current capacity must be less than the capacity that the human body can accept as a safe current. The preference for the type of output current is a design choice aimed at achieving the best configuration for the desired operation during the application of a functional therapy session.

[0009] In this regard, there are basically two types of neuromodulation devices. That is, invasive ones that are implanted into the patient's body at positions determined by a doctor for nerve stimulation, and non-invasive or extracorporeal ones that are installed in contact with the skin from outside the body at the treatment site of the patient's body.

[0010] Neuromodulation devices designed for application with invasive techniques have significant drawbacks compared to neuromodulation devices for non-invasive techniques. This is because invasive techniques are inside the patient's body, bringing various health risks to the patient. The installation of this device is highly complex and requires a medical team, and its application can result in irreversible permanent side effects (such as organ failure, bleeding, infections, allergic rejection reactions, damage to surrounding tissues, loss of motor function in the limbs, mood modulation, cognitive impairment, risk of death, etc.), depending on the degree of injury.

[0011] Furthermore, if a neuromodulation device is installed using invasive techniques, it is almost impossible for the patient to have it removed in the future. This is because it is extremely difficult to remove something that has invaded organs, which are more sensitive parts of the human body, and it involves the same risks as during its installation, resulting in a high risk of death.

[0012] Despite the many risks, the development of neuromodulation techniques using invasive techniques is known to some extent in the current state of the art. For example, document BR112020020867-1 describes a treatment administration method using a neuromodulation device that can apply and adjust voltage and frequency during a patient's treatment session. In this case, in order to operate this device, it is necessary to implant it into the patient's body using invasive techniques.

[0013] Also, document US20230284982 describes an invasive neuromodulation technique using electrodes implanted in a patient.

[0014] The application of non-invasive techniques is performed externally on the patient's skin, and for this application, it is only necessary to bring the neuromodulation device into surface contact with the skin. Therefore, a non-invasive neuromodulation device can be easily attached to and removed from the contact part with the patient's treatment site.

[0015] However, a non-invasive neuromodulation device must transmit power from the device to the patient's body through this contact part. This current may be direct current, intermittent, pulsed, etc. Therefore, when connected to a neuromodulation device and placed on the skin of the patient at the treatment target site by one or more electrodes, the transmission of the current occurs and the nerve cells that form involuntary synapses are stimulated.

[0016] Techniques for non-invasive neuromodulation using an external device are also known in the state of the art. In this regard, the document BR202015033163-6 mentions a hand-held neuromodulator that uses transcutaneous electrical stimulation on the patient's skin. This is a dedicated device that can assist in overactive bladder dysfunction as a method of improving the awareness of urination and defecation. However, there is no mention at all about applying this solution in exercise therapy by muscle contraction and relaxation, in the treatment of chronic pain of the patient, or in combination with a stimulation system.

[0017] The document PI0304175-1 describes a neuromuscular stimulation device consisting of an electronic circuit characterized by two or more adjustable amplitude current pulse sources connected to an output transformer, and each power source corresponds to the fluctuation range of the amplitude of the stimulation current pulse. The stimulation device mentioned in this technical document in the state of the art is an external type, the operation is extremely simple, and it is not managed by a system with functions of applying stimulation and, in particular, controlling the patient's body reaction to the applied stimulation. Furthermore, it is not described to apply this stimulation to relieve chronic pain.

[0018] Document US10610688 refers to a system and method for managing a patient's pain. The system includes a sensor configured to detect physiological or functional signals, and a pain analyzer that generates signal metrics from the physiological or functional signals. The pain analyzer also generates a weighting factor corresponding to the signal metrics. The weighting factor can indicate the reliability of the signal metrics representing the intensity of pain. The pain analyzer generates a pain score using a plurality of signal metrics and a plurality of weighting factors. The pain score is transmitted to a user or method. The system may further include an electrical stimulation device that generates and manages closed-loop pain treatment according to the pain score.

[0019] Furthermore, stimulation systems for controlling and managing neuromodulators are known, but these commercially available stimulation systems known in the literature (Venugopalan, 2020; Shideler, 2020) have limitations in terms of data communication, processing, and storage mainly due to the overall complexity associated with sensor fusion, joint angle calculation, identification of dynamic models, controller design, and tuning.

[0020] Therefore, considering the state of the art, there is a need for a neuromodulation device for functional rehabilitation therapy and pain therapy that is non-invasive, easy to use and practical, associated with a stimulation / control system for functional rehabilitation therapy and pain therapy, and can provide a non-invasive treatment approach. Furthermore, this system must be able to provide exercise rehabilitation therapy such that the patient can recover movement and relieve chronic pain, enabling accurate control of standardized electrical stimulation provided from the generation of modulation pulses that can meet the individual scientific and medical criteria of each patient, including data collection, computational processing. SUMMARY OF THE INVENTION

[0021] Accordingly, an object of the present invention is to provide a neuromodulation device for functional rehabilitation therapy and pain therapy that can generate electrical pulses for external action on a patient and electroencephalogram modulation, and further enables direct communication with a stimulation / control system for functional rehabilitation therapy and pain therapy through a computing interface.

[0022] Another object of the present invention is to provide a stimulation / control system for functional rehabilitation therapy and pain therapy that can directly communicate with a neuromodulation device for functional rehabilitation and pain therapy, and collect biomechanical and physiological data used for processing and calculation to assist a control subsystem that monitors the patient and adjusts the neuromodulation device during treatment from the patient.

[0023] Thus, the present invention has as its object a neuromodulation device for functional rehabilitation and pain therapy, includes a housing body and a housing cover, at least one electronic plate is disposed within the housing body, and the neuromodulation device for functional rehabilitation and pain therapy includes at least one control plate having at least one microcontroller for adjustment function management, at least one actuator plate having at least one converter and an H-bridge, and at least one Wi-Fi module for connecting at least one sensor to transmit data to an artificial intelligence module and at least one server.

[0024] Another object of the present invention is a stimulation / control system for functional therapy and pain therapy, comprising at least one neuromodulation device for functional rehabilitation and pain therapy connected to at least one electrode and at least one sensor. It is related to a management subsystem and includes a control subsystem that continuously communicates with a neuromodulation device for functional rehabilitation and pain treatment and at least one sensor. The control subsystem processes input parameters received from the management subsystem and / or at least one sensor to adjust a neuromodulation device for functional rehabilitation and pain treatment to apply electrical stimulation to at least one receiving user.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0026] An object of the invention according to the present disclosure is to restore the motor function of patients in need of functional therapy, perform rehabilitation, and use functional electrical stimulation by neuromodulation, devised by non-invasive or extracorporeal techniques, to treat chronic pain in patients, and relates to the field of neuroprosthetics (Neuro prosthetics: nerve prosthesis).

[0027] Neuroprosthetics is understood to be a physical device that interacts with a patient's nervous system and can transmit and receive signals to the patient's brain by means of electrical stimulation applied by non-invasive means.

[0028] In this regard, the patient is also identified as a receiving user, but is the person who receives electrical stimulation during a treatment session or a functional therapy session. The physician or medical professional is the person who is responsible for setting, controlling, and instructing the input / output data of the system during the treatment session, as detailed below.

[0029] According to a first configuration of the neuromodulation device for functional rehabilitation and pain treatment shown in FIGS. 1 to 10, this neuromodulation device 1 includes a housing formed by a housing main body 8 and a housing cover 6, in which at least one electronic plate 7 is arranged (FIG. 5). This housing can be made of materials such as polymer, ceramic, wood, metal, fabric, rubber, etc., or a combination thereof. The connection between the housing main body 8 and the housing cover 6 is preferably carried out by engaging a flap 61 arranged on the housing cover 6 with a recess 81 existing in the housing main body 8. However, among other possibilities of firmly associating the housing cover 6 with the housing main body 8, other types of connections such as fastening elements (adhesives, screws, nails, clamps, etc.), mechanical interference, press-fit connections, etc. can also be used.

[0030] The electronic plate 7 shown in FIGS. 5 and 6 is the electronic system of the neuromodulation device 1. This electronic system plays a role in forming the electrical stimulation wave applied to the patient by the neuromodulation device 1. This electronic plate 7 is substantially composed of at least one processor 9, at least one transformer 12, at least one light indicator 2, at least one activation switch 4, at least one power input adapter 3, at least one power output adapter 5, at least one current converter for enabling the use of either direct current or alternating current, at least one transistor 13, at least one electrical resistor 11, at least one capacitor, at least one voltage booster circuit, at least one voltage regulator circuit, at least one battery charging circuit, and at least one communication connection module 10 responsible for communicating between the management system and the control system as described later.

[0031] The arrangement of these components of the electronic plate 7 follows the configuration shown in FIG. 11.

[0032] As shown in FIG. 12, the neuromodulation device 1 applies an electrical stimulation wave to the patient by means of at least one electrical stimulation device or electrode 24 arranged on the patient's skin at a determined position in an extracorporeal manner, that is, without being inserted into the patient's body. In this way, the electrical stimulation device or electrode 24 non-invasively transmits the energy regulated by the neuromodulation device 1 to the patient.

[0033] The electrical stimulation device or electrode 24 shown in FIG. 12 is made of a non-insulating porous membrane and can be connected to the neuromodulation device 1 via a cable 121 or by wireless communication. These electrical stimulation devices or electrodes 24 are arranged at the body part of the patient to be treated by a functional therapy session or chronic pain treatment or non-pain treatment. The energy charge in the shape of an electric wave from the neuromodulation device 1 is preferably transmitted to the patient's body part in a pulsating form and acts on the patient's muscle tissue and nervous system.

[0034] Together with the electrical stimulation device or electrode 24, the sensor 14 is also arranged on the patient's body and plays a role in capturing the reaction of the patient's body after receiving the regulation of the electrical energy supplied from the neuromodulation device 1 via the electrical stimulation device or electrode 24.

[0035] According to FIGS. 9 and 10, the sensor 14 includes a hollow body 17 made of materials such as plastic, metal, rubber, wood, etc., and a part of the closing part 20. Inside the hollow body 17, at least one transmission module 19, at least one sensing module 18, and at least one battery 21 are arranged. The hollow body 17 serves to protect these components without interfering with their respective functions. The connection between the closing part 20 and the hollow body 17 is made by screws, nails, or mechanical fitting.

[0036] The battery 21 supplies power to the sensor 14 when the sensor 14 is not connected to the neuromodulation device 1 via the cable 121. The sensory module 18 has the function of capturing biomechanical and physiological data captured by these sensors from the patient's body reaction, and the transmission module 19 plays a role in facilitating communication between the sensor 14, the neuromodulation device 1, and the electrical stimulation system.

[0037] In use, at least one sensor 14 is placed on the patient's skin, that is, in a non-invasive manner, near the site where electrical stimulation is received. The sensor 14 captures biomechanical and physiological data captured by this type of sensor and converts it into binary data transmitted to the control system 27. The biomechanical and physiological data acquired by the sensor 14 from the patient may include temperature, blood pressure, movement, angle, contraction, brain signals, humidity, deformation, etc., among other data that the patient can generate with the body.

[0038] The sensor 14 can also function while collecting multiple types of biomechanical and physiological data simultaneously, or can collect at least one biomechanical and physiological data from the patient. The type of sensor 14 to be used can be selected by the control user, but the operation of this sensor 14 in conjunction with the electrical stimulation system detailed below remains unchanged.

[0039] The sensor 14 and the electrode 24 may be separate, or optionally, as shown in FIG. 13, they may be in a joint configuration housed in the same housing 23. In the joint configuration, each device performs the same function as determined in a separate configuration. That is, this configuration does not change the function of each device, nor does it change the result of the treatment session.

[0040] The method by which the sensor 14 communicates with the neuromodulation device 1 and the electrical stimulation system can be by data transmission via wire 121 or wirelessly. Wireless technology can be a technology that enables wireless data transmission, such as a Wi-Fi connection system, a mobile data network, Bluetooth (registered trademark), infrared, etc.

[0041] In the second configuration shown in FIGS. 14 to 16, the neuromodulation device for functional rehabilitation and pain treatment, that is, the neuromodulation device 100 includes a casing formed by a housing base 108 and a housing cover 106, and the casing receives an electronic plate 7 therein.

[0042]

[0041] The main objective of the neuromodulation device 100 is to apply standardized electrical stimulation that meets the criteria tailored to the patient. For this purpose, as shown in FIG. 15, in addition to including the components described for the first configuration of the neuromodulation device 1, the electronic plate 7 of the neuromodulation device 100 further includes a control plate 71 and at least one actuator plate 72. The control plate 71 includes a microcontroller and auxiliary components, and the actuator plate 72 includes a boost converter having a function of boosting a direct current (DC) current voltage from an input of 9 to 12 V to a value of 200 to 600 V, and an H-bridge having a function of reversing the direction of the current as necessary, for example, in the case of an alternating current (AC) power supply. Preferably, the neuromodulation device 100 is formed by a plate controller 71 and two plate actuators 72 that communicate with the electrodes 24 to apply electrical stimulation to the patient.

[0043] Furthermore, the neuromodulation device 100 includes a Wi-Fi module (not shown) embedded in its electronic plate 7. The neuromodulation device 100 generally connects to an available Wi-Fi network through an initial setup process including network selection, password input, etc. Once set, the neuromodulation device 100 establishes a Wi-Fi connection with a router or access point. The Wi-Fi module enables the creation of various applications such as Internet of Things (IoT) design, remote access, web servers, and data loggers, and as will be described later, connects the neuromodulation device 100 to a wireless network and enables its remote management via the web.

[0044] The microcontroller coupled to the plate control unit 71 is responsible for managing all the main functions of the neuromodulation device 100, including both the PWM (pulse width modulation) and the generation frequency of the waves in the output, as well as communication with the Wi-Fi module. Thus, in terms of wave generation, the neuromodulation device 100 generates a rectangular signal of a customized frequency in a separated manner and also generates a sine wave signal using the boost converter described above. FIG. 16 shows the types of waves that may be generated by the neuromodulation device 100 according to the electronic arrangement described herein.

[0045] As already described, the neuromodulation device 100 is responsible for the generation of electrical pulses and the regulation of brain waves. For this reason, the neuromodulation device 100 is interlocked with at least one electrode 24 and at least one sensor 140 (FIG. 17). Since the neuromodulation device 100 is driven by a rechargeable battery, it is portable and can be continuously used by the patient. Optionally, the neuromodulation device 100 may be equipped with a wireless charging system.

[0046] Similar to the first configuration, the electrode 24 is in direct contact with the patient's skin and has the function of transmitting the electrical pulses generated by the neuromodulation device 100 to the patient's body at the positions determined by the controlling user or medical expert 25, ensuring accurate and effective non-invasive stimulation.

[0047] Similar to the first configuration of this component, the second configuration of the sensor 140 collects biomechanical and physiological data sent from the patient's body during the use of the neuromodulation device 100 from the patient. This biomechanical data is used for the processing and calculation of joint angles and aids in the determination by the artificial intelligence (AI) 201 module described later.

[0048] As shown in FIGS. 17 and 18, in the second configuration, the electronic part of the sensor 140 is divided into two main components: a control board 141 composed of a voltage regulator, a trimming resistor, and a microcontroller, and an inertial module 142 connected to the control board 141. In addition to these components, the startup resistor of the microcontroller and an information LED are also used. The microcontroller communicates with the Wi-Fi module to receive commands and is responsible for starting the streaming of data from the sensor 140. The inertial module 142 obtains a reference from the accelerometer and is used to determine the position of the sensor. The information LED has the function of indicating the on / off state of the sensor. In this case, the LED may be an RGB LED, and functions such as on, connection standby, and discharge can be programmed.

[0049] The sensor 140 is driven by a 1000 mAh battery 143. Further, a button 144 is used for turning the system on / off, and there is a simple LED indicating the on state. The charging of the battery 143 is performed via a wired connector, and a micro USB charger or an external lithium battery charging module can also be used.

[0050] The neuromodulation devices 1, 100 are the main components of a stimulation / control system for functional rehabilitation therapy and pain therapy, which is also an object of the present invention. With the neuromodulation devices 1, 100, the stimulation / control system can collect biomechanical and physiological data from a patient, and, regardless of the presence or absence of personalization, process the collected data as needed and mainly in response to the biomechanical response of the patient's body to adjust the functions of the neuromodulation devices 1, 100 for functional therapy or chronic pain therapy sessions.

[0051] As shown in FIG. 19, generally speaking, a stimulation / control system for functional rehabilitation therapy and pain therapy, which is an object of the present invention, includes a management subsystem 26. The management subsystem 26 is accessed by at least one control user or medical user 25, and acts on at least one neuromodulation device 1, 100 by a control subsystem 27 to provide a functional therapy session or pain therapy session customized according to the parameters of at least one patient or receiving user 28 to that patient or receiving user 28.

[0052] In this regard, as also shown in FIGS. 20, 21, and 22, the control subsystem 27 uses input parameters that can be provided by the management subsystem 26. The input parameters are received through feedback from data from at least one sensor 14 by access by the control user or medical professional 25, or by querying a database 30 (FIG. 22). Optionally, as shown in FIG. 21, the input parameters used by the control subsystem 27 are transmitted from the management subsystem 26, and the management subsystem 26 obtains the input parameters from data feedback from at least one sensor 14, or from information input by the receiving user or patient 28 himself / herself into this management subsystem 26.

[0053] These input parameters used by the control subsystem 27 consist of data of the recipient or patient 28, such as gender, age, weight, height, medical information regarding motor ability and pain, setting data of the neuromodulation device 1, information regarding the amount and duration of the treatment session, etc.

[0054] Based on the received and processed parameters, the control subsystem 27 sets or adjusts the settings of the neuromodulation device 1 so that the neuromodulation device 1 modulates the signal and applies electrical stimulation to the patient 28. The communication between the control subsystem 27 and the neuromodulation device 1 is performed via the communication connection module 10 arranged on the electronic plate 7 of the neuromodulation device 1. In order for modulation to be performed, the neuromodulation device 1 needs to be connected to at least one power input, which can be obtained from the local power grid or from the battery of the neuromodulation device 1. The current supplied to the neuromodulation device 1 can be a continuous current CC or an alternating current AC, and thus the current output can be converted to a more convenient type to obtain the best results in the treatment session.

[0055] When the neuromodulation device 1 is activated by the control subsystem 27, the transmission of energy by radio waves or electrical stimulation is delivered to the receiving user, i.e., the patient 28, via the electrode 24 arranged on the skin of the patient 28 in the area of the body 28 of the patient in whom the functional therapy session or the physical therapy session is being performed (i.e., to perform the movement of the patient's body 28 or to conduct a treatment session for pain relief of the patient 28, whether chronic or not).

[0056] While applying electrical stimulation to patient 28, sensor 14 captures external biomechanical and physiological data, or biomechanical and physiological data generated by patient 28's body, converts this information into binary data, and transmits it as feedback to control subsystem 27. Control subsystem 27 may store this information in at least one database 30, or may transmit it to management subsystem 26. Management subsystem 26 provides the information to the control user or physician 25 for evaluation. These biomechanical and physiological data captured by this type of sensor may include movement, angle, contraction, brain signals, etc. among other data generated by patient 28's body during and / or immediately after the treatment session.

[0057] Furthermore, sensor 14 can establish input parameters for control subsystem 27 so that the stimulation / control system can initiate operation. The use of these parameters is an option that the control user 25 can select on management subsystem 26 for the purpose of improving the efficiency of the treatment session.

[0058] Therefore, the input parameters for the settings of neuromodulation device 1 can be set by manual input by the control user or medical professional 25, querying the database 30 connected to control subsystem 27, or by the feedback generated by sensor 14.

[0059] The input data input into the stimulation / control system passes through control subsystem 27. The data provided by control subsystem 27 is transmitted to neuromodulation device 1 and used to adjust the parameters for transmitting energy or electrical stimulation to the receiving user or patient 28. Therefore, control subsystem 27 is responsible for current, voltage, type of current, frequency, and the correlation, balance, and parameterization of the movement angle.

[0060] In this regard, the operation of the control subsystem 27 is governed by mathematical and physical equations that measure input parameters so that the output of electrical energy by the neuromodulation device 1 is as efficient as possible for a desired treatment session. Basically, the control subsystem 27 receives at least one physical input parameter and converts it into an output parameter of the neuromodulation device 1 so that this neuromodulation device 1 can read the energy and transmit it to the patient 28.

[0061] Therefore, as shown in detail in FIG. 22, the operation mode of the control subsystem 27 is formed by two operation lines. In the first line, information reaches the control subsystem 27 through the sensor 14. In this case, the control subsystem 27 processes the received information, and the information is transmitted for numerical interaction. The information after the numerical interaction can be included in the database 30 and follows the physical calculation rules until it is sent to the neuromodulation device 1.

[0062] In the second line of operation, information reaches the control subsystem 27 via the management subsystem 26 activated by the control user 25. In this second option, the management subsystem 26 queries the database 30 for data and transmits the information to the control subsystem 27. When entering the control subsystem 27, this information is sent to the neuromodulation device 1 through the physical calculation rules.

[0063] Options of these stimulation / control systems are schematically shown in FIGS. 23 and 24. As shown in FIG. 23, the stimulation / control system can be used by a control user 25. Different from the receiving user 28, the control user 25 activates a management subsystem 26 that communicates with a control subsystem 27, and transmits parameters to a neuromodulation device 1 so as to apply an electrical stimulation to the receiving user 28 via an electrode 24. Simultaneously with the application, a sensor 14 acquires biomechanical data from the receiving user 28 and transmits it as data feedback to the control subsystem 27 via the neuromodulation device 1 or directly.

[0064] FIG. 24 shows the same operation as described above, but the control user 28 is the same receiving user 28 who receives the benefits occurring during the treatment session.

[0065] As shown in FIG. 25, in an alternative configuration using a second configuration of the neuromodulation device 100, the stimulation / control system includes at least one electrode 24 and at least one sensor 140 disposed on the patient's body in a non-invasive manner, and guarantees the accuracy of the delivery of electrical stimulation and the capture of biomechanical data of the patient 28 respectively.

[0066] The neuromodulation device 100 is connected to the electrode 24 by a wire, and through the electrode 24, the neuromodulation device 100 applies stimulation to the patient 28 according to a customized schedule. Further, the neuromodulation device 100 is also connected to the sensor 140 via a Wi-Fi network. The neuromodulation device 100 and the sensor 140 communicate with an access computer 200 via the Wi-Fi network. The access computer 200 has a management subsystem 26 and a control subsystem 27.

[0067] Sensor 140 captures biomechanical data from patient 28 during a treatment session, and these biomechanical data are then processed by an artificial intelligence (AI) module 201 in server 202. Server 202 plays a role in ensuring the accuracy of calculations regarding the stimulation. Thereby, it can predict the operation of the system based on the data received in real time and generate predictive control actions. Furthermore, the server also provides an efficient IoT connection and optimizes data exchange between devices.

[0068] Access computer 200 has an administrative subsystem 26 and a control subsystem 27. Thus, access computer 200 can communicate with server 202 and cloud server 204, enabling patient management or administration, connection to the neuromodulation device 100, and adjustment of stimulation parameters via a computing interface.

[0069] The computing interface or user interface is a web page, mobile application, or desktop application with a set of buttons that enables a user to remotely set and control the neuromodulation device 100 to manage one or more patients, personal data, clinical data, and respective protocols. This user interface also provides the patient's biological information to medical professionals.

[0070] Functional and exercise therapy sessions for patient 28 using the stimulation / control system and neuromodulation devices 1, 100 for functional therapy and pain treatment are performed through neuromodulation of a specific frequency of electric current that directly targets the patient's nervous system, causing relaxation and contraction responses in the patient's muscle tissue.

[0071] To enable the patient to move their limbs, the neuromodulation devices 1, 100 are responsible for the ideal moments that can promote the contraction and relaxation of the patient's 28 muscles through logical sequences and electrical stimulation, and generate angular movements of the limbs. This logical sequence is periodically repeated in a fixed or variable manner according to the angles, streams, voltages, frequencies, and resultant information captured and presented by the sensors 14, 140.

[0072] To perform the control of involuntarily moving the patient's 28 limbs with respect to the patient's body 28, the stimulation / control system for functional therapy and pain treatment uses the input data that establishes the open angle and the stop of movement in its control subsystem 27. This input data can be directly input into the control subsystem 27 by the management system 26, or can also be input by the feedback from the biomechanical and physiological data collected by the sensors 14, 140. In this way, the management system 26 can present to the control user 25 the arrangement of information such as input and output parameters, executed and future logical sequences, two-dimensional or three-dimensional visualization of the patient's 28 body parts, and biomechanical information captured by the sensors 14, 140.

[0073] The stimulation / control system for functional therapy and pain is also used in treatment sessions to relieve the patient's 28 visceral pain and chronic pain sensations, and this function may be, to some extent, the result of the contraction and relaxation of muscle tissue. It is emphasized that electrical stimulation is a widely used treatment technique in pain treatment that uses controlled electrical impulses to stimulate muscle and nerve tissue. Its main purpose is to regulate nerve activity and promote pain relief.

[0074] In the case of a treatment session for alleviating visceral pain or chronic pain, for the functional therapy and the stimulation / control system for pain, electrodes 24 and sensors 14, 140 are placed on an arbitrary part of the skin of patient 28, and low-intensity electrical impulses are transmitted to stimulate peripheral nerve fibers to manage the pain that patient 28 has in the body. The frequency and intensity of the stimulation are always adjusted according to the type and degree of pain under the guidance of a trained medical professional.

[0075] This mechanism of action of electrical stimulation is mainly based on the gate control theory. In this theory, it is proposed that by activating nerve fibers with a larger diameter, electrical impulses block the transmission of pain signals to the brain and effectively "close" the pain gate in the neural pathway.

[0076] Therefore, the control of visceral pain is technically carried out through the neuromodulation devices 1, 100, and the neuromodulation devices 1, 100 perform neuromodulation of current and frequency within a specific operating range that prevents the patient's nervous system 28 from transmitting local disorders that occur in pain perception to the brain so that the transmission between the nervous system and the patient's brain is suppressed.

[0077] For the stimulation / control system for functional therapy and pain treatment to act systematically on various types of human bodies of various patients, the neuromodulation devices 1, 100 operate within a suitable frequency range, current, voltage, and angle. The operating range of the device corresponds to different electrical stimulations. However, the physical characteristics are maintained so that the control subsystem 27 does not change even when the electrical stimulation changes.

[0078] In this sense, the energy output of the neuromodulation devices 1, 100 can vary within a range where the voltage is preferably 1 to 500 V, the current is 0 to 1.0 A, and the frequency is 0 to 5000 Hz. In this context, the movement angle can be from 0° to 360° on any axis on which patient 28 can perform movements.

[0079] These output parameters can be preset or post-set within these presented ranges, and the combinations of iterations executed among the parameters can operate in a substantially probabilistic setting. This setting presents configurations where one parameter is fixed and the others vary, two parameters are fixed and the other two vary, three parameters are fixed and the other parameters vary, or all four vary simultaneously.

[0080] The control of the variation of these parameters can be performed automatically by the control subsystem 27 or manually by the intervention of the control user 25 during the treatment session.

[0081] As shown in FIG. 26, the use of the stimulation / control system for functional therapy and pain treatment by the user is performed in a simple manner. In step A, the user, who is either the control user 25 or the receiving user 28, logs into the system using the provided authentication information. Next, in step B, the user follows a protocol for setting the clinical data of the receiving user, i.e., the patient 28, such as filling out a medical form and recording other relevant information. In step C, the user accesses the neuromodulation device units 1, 100, adjusts the specific parameters of the treatment session (functional therapy session for motor ability or treatment session for pain) that the patient 28 will receive, and confirms that all settings are appropriate for the treatment needs of the patient 28. Step D involves setting the neuromodulation devices 1, 100, connecting to the Internet, and adjusting the technical parameters according to the treatment specifications. Next, in step E, the user places the electrodes 24 and sensors 14, 140 on the patient's body 28 according to the guidelines detailed in the manual to ensure the accuracy and effectiveness of the treatment. After all preparations are complete, in step F, the user activates the stimulation / control system for functional therapy and pain treatment, monitors the performance of the neuromodulation devices 1, 100 during the treatment session, and tracks the patient's progress and response in real time. After the end of the treatment session, the stimulation / control system for functional therapy and pain treatment creates a bioreaction report in step G. This report provides a detailed analysis of the collected data, and the user can evaluate the effectiveness of the treatment and adjust future treatments as needed.

[0082] The stimulation / control system for functional therapy and pain treatment, as well as the neuromodulation devices 1, 100 for functional and pain treatment, both use non-invasive techniques, enable the adjustment of current, frequency, voltage, and angle, and only require contacting the electrodes 24 and inertial sensors 14, 140 with the patient's skin to capture the biomechanical and physiological information of the patient captured by this type of sensor.

[0083] Non-invasive techniques offer various benefits to the patient's health, such as reducing or avoiding nerve cell damage, bleeding, infection, allergic rejection reactions, damage to surrounding tissues, decreased motor function in the limbs, mood changes, cognitive impairment, and the risk of death. Even when using the present invention, the patient's body is maintained without being damaged. This is because the neuromodulation devices 1, 100 operate through surface contact with the patient's skin, which is achieved by the electrodes 14 and sensors 14, 140 disposed at sites on any surface of the patient's body, as already described.

[0084] Another advantage of a stimulation / control system for functional therapy and pain treatment, such as the neuromodulation devices 1, 100 for functional therapy and pain treatment, is that the neuromodulation devices 1, 100 are portable and can communicate remotely with the stimulation / control system for functional therapy and pain treatment for necessary setting adjustments and obtaining return information.

[0085] Thus, by using a stimulation / control system for functional therapy and pain treatment such as the neuromodulation devices 1, 100, nerve and muscle tissues can recover, the nervous system can be readjusted, and visceral pain or chronic pain in the patient 28 may be alleviated over the long term.

[0086] Particularly for the neuromodulation devices 1, 100, electrodes 24, and sensors 14, 140, they can have various geometric shapes, providing greater freedom so that they can be used in the most convenient form regardless of size, according to the profile of the receiving user, i.e., the patient 28 (adult, elderly, child), and the requirements of the sites on the patient's body 28 for receiving the electrodes 24 and sensors 14, 140. In this regard, FIG. 27 shows an example of the format of the neuromodulation devices 1, 100, electrodes 24, and sensors 14, 140, but many other formats can be used as long as they are functional.

[0087] Furthermore, in connection with the neuromodulation devices 1, 100, these may present one or more information inputs, one or more information outputs, one or more light indicators, and one or more graphical displays of both the immediate information and the executed parameters.

[0088] While the preferred embodiments have been described, it is to be understood that the scope of the present subject matter is limited only by the content of the appended claims, including possible equivalents, and encompasses other possible variations.

Claims

1. A neuromodulation device (1, 100) for functional rehabilitation and pain treatment, comprising a housing body (8, 108) and a housing cover (6, 106), in which at least one electronic plate (7) is arranged, The electronic plate (7) At least one control plate (71) with at least one microcontroller for managing the adjustment functions; At least one actuator plate (72) with at least one converter and an H-bridge; at least one Wi-Fi module for connecting at least one sensor (14, 140) to transmit data to an artificial intelligence module (201) and to at least one server (202), Neuromodulation devices.

2. 2. The neurostimulation device of claim 1, wherein the neurostimulation device is connected to at least one electrode (24) for providing customized electrical stimulation to at least one recipient user (28), the at least one electrode (24) being positioned outside the body of the recipient user (28).

3. 2. The neuromodulation device of claim 1, wherein the microcontroller is coupled to the plate controller (71) for managing pulse modulation, frequency, and output wave generation.

4. The neuromodulation device of claim 1 , which is handheld.

5. 1. A stimulation / control system for functional therapy and pain treatment, comprising: at least one neuromodulation device (1, 100) for functional rehabilitation and pain treatment as defined in claims 1 to 4, connected to at least one electrode (24) and to at least one sensor (14, 140); a control subsystem (27) associated with a management subsystem (26) and in continuous communication with said neuromodulation device for functional rehabilitation and pain treatment (1, 100) and said at least one sensor (14, 140); Equipped with the control subsystem (27) processes input parameters received from the management subsystem (26) and / or the at least one sensor (14, 140) to adjust a neuromodulation device (1, 100) for functional rehabilitation and pain treatment to apply electrical stimulation to at least one recipient user (28); A system characterized in that

6. 6. The system of claim 5, wherein the input parameters of the control subsystem (27) are obtained from a database (30).

7. 6. The system of claim 5, wherein the input parameters provided by the management subsystem (26) result from feedback from data from at least one sensor (14, 140) or from information entered into the management subsystem (26) by the receiving user (28) or a controlling user (25).

8. The system according to claim 5, characterized in that the communication between the control subsystem (27) and the neuromodulation device for functional rehabilitation and pain treatment (1, 100) is performed by a communication connection module (10).

9. The system according to claim 5, characterized in that the neuromodulation device (1, 100) for functional rehabilitation and pain treatment is connected to at least one sensor (14, 140) via a Wi-Fi network.

10. The system according to any one of claims 5 to 9, characterized in that the input parameters are entered into the management subsystem (26) by a control user (25) or a receiving user (28) via an interface.

11. 11. The system according to claim 10, characterized in that at least one sensor (14, 140) collects biomechanical parameters from the recipient user (28) for processing in an artificial intelligence module (201).

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