System and method for generating electromagnetic treatment protocols based on biophysical signal readings - Patents.com
The system addresses the limitations of existing electromagnetic therapy systems by using real-time biophysical signal feedback to adaptively adjust electromagnetic field parameters, resulting in a more effective and personalized treatment for nervous system disorders and injuries.
Patent Information
- Application Number
- JP2023553510
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2021-03-04
- Publication Date
- 2025-05-19
- Estimated Expiration
- 2041-03-04
AI Technical Summary
Existing electromagnetic therapy systems for treating nervous system disorders and injuries lack the ability to adapt in real-time to the dynamic changes in human tissue characteristics and body responses, leading to less effective treatment outcomes.
A system and method that generate a personalized electromagnetic therapy protocol by continuously reading biophysical signals and adjusting the electromagnetic field parameters in real-time using a feedback loop between sensors and emitters, ensuring optimal treatment efficacy for each patient.
This approach allows for precise and adaptive treatment, enhancing the therapeutic effect by aligning the electromagnetic field with the natural resonance frequencies of specific cell types, thereby promoting functional recovery and tissue regeneration.
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Abstract
Description
Technical Field
[0001] The present invention relates to electromagnetic therapy of the nervous system, other tissues, or any organ suffering from injury, inflammation, or ischemia, including infectious diseases, deficiency diseases, genetic diseases (including both genetic and non-genetic diseases), and physiological diseases, as well as other diseases. More specifically, the present invention relates to a system and method for generating an electromagnetic therapy protocol while reading biophysical signals.
Background Art
[0002] An electromagnetic field (EMF) is a vector field generated by the displacement of charged objects where an energy interaction occurs with other charges or electromagnetic fields. An electric field represents the space where a charge exerts an electrical force on another charged object in its vicinity, while a magnetic field is a field where a charge is affected by magnetism.
[0003] Electromagnetic fields are divided into uniform and non-uniform fields according to their nature or type and direction. A uniform field is characterized by spatial consistency, and a non-uniform field is spatially variable. When the nature of the field changes with respect to time, the field is called a time-varying field. These fields can then not only interact with the charges in their vicinity but also affect each other. Just as a changing magnetic field induces an electric field, a changing electric field induces a magnetic field.
[0004] As degeneration and demyelination progress within the nervous system or as inflammation occurs in other parts of the body, many ion channels undergo changes in activation dynamics and distribution along the cell membrane, resulting in ion flow and imbalances in extracellular or intracellular concentrations. Since one of the main characteristics of electromagnetic fields is the ability to affect charged objects in their vicinity, EMFs can modify the charge distribution along the cell membrane. They can also direct the movement of ions and control the activity of voltage-dependent ion channels.
[0005] The inherent electrical charges of all cells within the central nervous system are susceptible to the influence of electromagnetic fields. Currently, the most common methods of electromagnetic field administration to brain tissue consist of vagus nerve stimulation (VNS), (repetitive) transcranial magnetic stimulation (rTMS), deep brain stimulation (DBS), pulsed electromagnetic fields (PEMF), and low-frequency magnetic fields (LF-MF), all of which, in some form, affect signal transmission through neurons and their activity.
[0006] Therefore, the application of time-varying electromagnetic fields targeting the nervous system has been demonstrated to promote functional recovery after trauma, stroke, and spinal cord injury, and further to manage pain and reduce inflammation. This application also shows potential for future use in treating other brain or nervous system pathologies such as autism, Alzheimer's disease, epilepsy, Parkinson's disease, attention deficit hyperactivity disorder (ADHD), or other health conditions.
[0007] To diagnose diseases and further track disease progression and treatment success, various techniques have been developed to measure the activity of the brain and nervous system. For example, electroencephalography (EEG) can be utilized to measure overall brain activity. Magnetoencephalography (MEG) can be used to map local brain activity near the outer surface of the brain. Functional magnetic resonance imaging (fMRI) can acquire both spatial and temporal images of brain activity.
[0008] PCT International Publication No. WO 2018 / 047164 discloses a system that simultaneously performs cognitive tasks and imaging using EEG, MEG, and fMRI technologies to provide an image of a patient's brain, which, after digitally scanning the patient's brain, includes generating a treatment protocol by comparing a digital image of the patient's brain with one or more images of other patients' brains. The treatment is then set based on previous diagnoses. WO 2018 / 047164 focuses on determining which parts of the brain need to be stimulated by creating a digital image of the patient's brain and comparing the inactive parts with images of other patients. Furthermore, the system of WO 2018 / 047164 focuses on generating a bulk space map of neural activity for generating a treatment protocol and inputting it into an electromagnetic field generator, but aims to treat the specified impaired functionality using all specified treatment frequencies. Since this system generates a treatment electromagnetic field to treat neural network dysfunctions, it appears to perform a systemic treatment that affects both the functional parts of the brain and the parts of the impaired function. WO 2018 / 047164 consists of a communication interface for receiving information including data collected from a series of neural activity sensors placed on a patient during an applied stimulation session, and a processor configured to generate a plurality of different treatment protocols. However, the system of the present invention consists of a portable unit with built-in sensors that functions on a feedback loop with an emitter for the purpose of personalizing the treatment during its application itself, as well as a fixed unit for treatment design, treatment monitoring, and calibration.
[0009] U.S. Patent Application Publication No. 2017 / 0087367 uses MEG, EEG, tMRI technology, PET scans, SPECT, ECOG, sMRI, OTT, MRS, and fNRIS to digitally visualize the appearance of the brain and diagnose areas of the brain with dysfunction. A system for treatment consists of a housing for placing at least one electrode with respect to an area of tissue, the housing defining a cavity or channel such that an opening defined through the at least one electrode is open to the cavity or channel. This system functions based on the principle of the "ramp up / ramp down" method for gradually increasing the strength of the radiation field selected from one of the stimulation modes from the group of transcranial magnetic stimulation (TMS), repetitive TMS (rTMS), pulsed electromagnetic fields (PEMF), transcranial alternating current stimulation (TACS), transcranial random noise stimulation (TRNS), time-varying electrical stimulation (TVES), and ultrasound brain stimulation (UBS).
[0010] One of the drawbacks of the foregoing disclosure is planning a treatment protocol that is kept constant during a single treatment period without considering the fact that the human body is a dynamic system with constantly changing characteristics and states. Thus, applying a constant treatment protocol over a treatment period not only ignores the real-time characteristics of human tissue and further the body's response, but is also less effective compared to the system of the present invention.
[0011] Another significant difference between the system and method of the present invention and most of the prior art disclosures is that most of the prior art focuses on improving the cognitive characteristics of patients after some trauma or illness for the purpose of functional changes in nerves or neurons, while in the system and method of the present invention, for patients with nervous system diseases such as Alzheimer's disease, multiple sclerosis, stroke, ALS, and any other autoimmune disease or other pathological conditions of the body, and even for cancer patients, in order to restore cell function through inducing histological changes in not only neurons but also other cell types, electromagnetic fields of various properties similar to the fields emitted by the patient's brain or other tissues (such as pulsating non-uniform time-varying electromagnetic fields) are used. Contrary to functioning only as a signal amplification tool, the electromagnetic fields of the present invention can affect different cell types such as connective tissue, nerve tissue, immune system, muscle tissue, or various cell processes (such as cell death, activity, migration, division, etc.) of organs in general, and can also be used to cause changes at the cellular level. The solution of the present invention functions by inducing the reorientation of molecules within the cell, causing deformation of the embedded ion channels, changing their activation kinetics, and further reorganizing the distribution of ions around the cell membrane as well as within and outside the cell. This causes cell polarity formation, changes in the rates of ion and ligand binding, amplification or attenuation of signal propagation, and even electromagnetic induction. In addition, the system and method of the present invention utilize a paired feedback loop between the emitter and the sensor to provide personalized treatment according to real-time sensor readings.
[0012] Another distinct difference between the disclosure of the prior art and the technical solution of the present invention is the pre-defined range of the intensity and frequency of the electromagnetic field specifically selected as optimal for each cell type within all major tissues and organs for the purpose of treatment optimization. The solution of the present invention takes into account the tissue inhomogeneity and defines, according to the general or target cell type, the pre-defined range of the intensity and frequency of the electromagnetic field to be used to achieve the optimal therapeutic effect on each organ or tissue when designing the treatment protocol. Since each cell in the human body has its own resonant frequency of the membrane channel, targeting the cells at these frequencies can increase or decrease the activity by causing a significant change in the ion flux across the cell membrane channels, which induces a change in cell function. This can be particularly important in treating autoimmune diseases such as multiple sclerosis where the activation of immune system cells is enhanced and demyelination is caused, as well as cancer and other diseases or disorders where the enhancement of cell activity becomes prominent and may lead to ongoing pathological events.
[0013] Therefore, the technical solution of the present invention significantly improves the previous systems, which includes pairing each of the sensors and emitters during treatment application and simultaneously monitoring in real time the patient's biological, chemical, and physical parameters for the purpose of modifying the treatment application and further inducing changes in various cell processes (cell death, activity, migration, division, etc.). In addition, the system is designed to be used in conjunction with cell transplantation so as to serve the purpose of electromagnetic induction or an induced drug delivery system for transplanted cells to the target site.
Prior Art Documents
Patent Documents
[0014]
Patent Document 1
Patent Document 2
Summary of the Invention
Problems to be Solved by the Invention
[0015] Accordingly, embodiments of the present invention provide a system and method for generating and applying an electromagnetic therapy protocol simultaneously with the reading of biological and / or biophysical and / or biochemical signals. Here, all future references to terms used herein refer to "biophysical", "biological", or "biochemical" signals, which correspond to any or all of the aforementioned signal types.
[0016] A system for generating an electromagnetic therapy protocol has two purposes: the application of an electromagnetic field and the measurement of electromagnetic fields, tissue impedance, resistance, and other parameters to monitor the success and progress of the applied therapy in real time. The system of the present invention is directed to generating a focused electromagnetic field that affects cells in some regions of the brain or any part of the body, and operates based on the principle of a feedback loop control system that automatically modifies the nature, frequency, and intensity of the applied electromagnetic field to optimize the course of the treatment being applied.
[0017] The main object of the present invention is to provide a protocol generation and treatment system for applying focused electromagnetic stimulation to a patient's brain, nervous system, or any part of the body simultaneously with the measurement of biological and / or biophysical and / or biochemical signals.
[0018] The protocol generation and treatment system of the present invention includes medical patient data, a plurality of baseline treatment protocolsa protocol, each baseline treatment protocol is associated with a plurality of baseline treatment protocols, general or target cell types, and a positioning map of one or more associated reference sensors and emitters associated with the directed impaired functionality of a particular disease or injury, inflammation, or ischemia, a nervous system, an organ, or other tissue, a reference range of electromagnetic field intensities and frequencies that provides an optimal treatment effect for each organ or tissue, and a representative nervous tissue, organ, and tissue profile associated with the reference electromagnetic field range for each nervous tissue, organ, and cell type of a healthy person, a main database configured to store at least one patient personal folder; machine learning software configured to compare medical patient data associated with a particular disease or directed impaired functionality, design and extrapolate one or more baseline treatment protocols associated with the particular disease or directed impaired functionality, provide one or more reference sensor and emitter positioning maps associated with the baseline treatment protocols, and determine which of the positioning maps and baseline treatment protocols are suitable for the patient; a portable device comprising an electromagnetic field generator configured to generate an electromagnetic field; an array of sensors configured to measure biophysical signals and an array of emitters configured to apply an electromagnetic field; a computing unit configured to record in real time the measured biophysical signals from each of the array of sensors, control the electromagnetic field generator to compare the measured biophysical signals with a reference electromagnetic field range, and apply a plurality of different electromagnetic fields through a power supply for the array of emitters and components of the portable device; and a fixed device configured to calibrate the portable device, inspect the array of sensors and emitters for accuracy, design a baseline treatment protocol, store the baseline treatment protocol and the reference sensor and emitter positioning map in the main database and the storage area of the portable device prior to patient use, and remotely control the operation of the portable device.
[0019] As used herein, the phrase "suitable for a patient" is defined as a set of essential and non-essential conditions that must be met for a treatment protocol or placement map to be selected. When a treatment protocol or placement map is obtained from medical patient data in a database, the set of essential conditions that must be met consists of the disease, the affected organ or tissue, the stage of disease progression or duration of symptoms, and the patient age. Non-essential conditions include, but are not limited to, the location of the affected organ, the medical history or results of previous diagnostic readings, and the current symptoms. If no treatment protocol that meets the foregoing conditions exists, the machine learning algorithm may derive a reference electromagnetic field range for each tissue or organ, and even a baseline placement map, and use it as a baseline treatment protocol.
Means for Solving the Problem
[0020] The computing unit is further configured to modify the electromagnetic field applied through each of the array of emitters while measuring the biophysical signals from each of the array of sensors, and each of the array of emitters and each of the array of sensors, positioned in close proximity to each other, operate as a pair, and the electromagnetic field applied through each emitter is continuously modified until it is achieved that the measured biological and / or biophysical and / or biochemical signals by the pair of sensors are within a reference electromagnetic field or signal range. The baseline treatment protocol can be modified until the sensor measures an electromagnetic field within the reference electromagnetic field range for that particular tissue or organ, or other biophysical signals within its reference range. This process of modifying the baseline treatment protocol will require creating a personalized treatment protocol. If the reference electromagnetic field range, or the activity profile corresponding to the reference range of other measurements, cannot be measured, the baseline treatment protocol is stopped and the patient may report to a healthcare facility or clinic for a check-in. Subsequently, it may continue with generating a new placement map, or reprogramming the sensors and emitters to continue a conservative therapy protocol where the sensor begins to record the response pattern of the tissue during the applied treatment. If the cell activity pattern does not show a change over time, the baseline treatment protocol can be adjusted to emit an electromagnetic field within the reference electromagnetic field range, taking into account the natural resonance frequency of a particular cell type, to induce electromagnetic induction in the surrounding tissue and achieve synchronization of cell activity with the reference electromagnetic field range. Additionally, a new sensor and emitter placement map may be generated and it may follow the baseline treatment protocol until a change in the sensor readings is observed.
[0021] Furthermore, according to one embodiment of the present invention, the generated baseline or individualized treatment protocol defines the characteristics of the applied electromagnetic field selected from the group of characteristics consisting of amplitude, frequency, intensity, direction, duration of application, and type.
[0022] Furthermore, according to one embodiment of the present invention, the generated baseline or personalized treatment protocol includes a reference range of electromagnetic field intensities and frequencies to be used for optimal therapeutic effect on each organ or tissue, depending on the general or target cell type.
[0023] Furthermore, according to one embodiment of the present invention, the applied electromagnetic field may be a constant or time-varying uniform and / or non-uniform electromagnetic field, or a combination thereof.
[0024] Furthermore, according to one embodiment of the present invention, a portable device is provided.
[0025] Furthermore, according to one embodiment of the present invention, the computing unit of the portable device is configured to modify the electromagnetic field applied through each of the array of emitters simultaneously with the measurement of the biophysical signals from each of the array of sensors, and each of the array of emitters and each of the array of sensors positioned in close proximity to each other operate as a pair.
[0026] Furthermore, according to one embodiment of the present invention, a method for generating a baseline treatment protocol is provided.
[0027] Furthermore, according to one embodiment of the present invention, a method for generating a personalized baseline treatment protocol is provided.
[0028] Furthermore, according to one embodiment of the present invention, a method for generating a reference sensor and emitter placement map is provided.
[0029] Details of various examples are set forth in the accompanying drawings and the following description. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.
Brief Description of the Drawings
[0030]
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DETAILED DESCRIPTION OF THE INVENTION
[0031] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, one of ordinary skill in the art will understand that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, components, devices, modules, units, and / or circuits have not been described in detail so as not to obscure the present invention.
[0032] Embodiments of the present invention are not limited in this regard. For example, descriptions using terms such as "processing", "computing", "calculating", "determining", "establishing", "analyzing", "checking", "computerized neural network", "machine learning", "deep learning", "signal processing", or similar expressions may refer to operations on data represented as physical (e.g., electronic) quantities in a computer's registers and / or memory and / or instructions for storing and / or executing operations and / or processes, and may also be converted into other data represented as physical quantities in other information non-transitory storage media (e.g., memory) such as a computer's registers and / or memory or other information non-transitory storage media (e.g., memory). Embodiments of the present invention are not limited in this regard. As used herein, "plurality", "a plurality", "array", and "an array" may include, for example, "a number" or "two or more". The terms "plurality" or "a plurality" may be used throughout this specification to describe two or more components, devices, elements, units, parameters, etc. Unless otherwise specified, the method embodiments described herein are not bound by a particular order or sequence. In addition, some of the described method embodiments or elements thereof may occur or be executed simultaneously, at the same time, or in parallel. Unless otherwise indicated, the conjunction "or" as used herein should be understood to be inclusive (any or all of the recited alternatives).
[0033] Some embodiments of the present invention include an article such as a computer, computing unit, or processor-readable medium, or any other type of storage medium, such as a memory, disk drive, USB flash memory, or a computer or processor non-transitory storage medium, that encodes, includes, or stores instructions, such as computer-executable instructions, that when executed by a processor, computing unit, or controller, perform the methods disclosed herein, which may or may not be in a specifically defined location (such as cloud storage).
[0034] The methods and systems described herein provide for characterizing readings of biophysical signals of the nervous system or other tissues / organs affected by injury, inflammation, ischemia, chronic conditions, or degeneration, and based on the readings of the biophysical signals, simultaneously and in real time setting electromagnetic field parameters for each region of the nervous system or other tissues affected by injury, inflammation, ischemia, chronic conditions, or degeneration.
[0035] As used herein, the term "electromagnetic field" refers to a constant or time-varying uniform and / or non-uniform electromagnetic field characterized by its intensity, direction, application duration, frequency, amplitude, and type.
[0036] The main objectives of the present invention are as follows. - The system operates based on the principle of personalized therapy by mimicking the electromagnetic properties (amplitude, frequency, wavelength, or intensity) or other biological, biophysical, or biochemical parameters of the brain or nervous system, other tissues, or any organ through information obtained from a plurality of sensors and biomarkers attached to the target part of the patient, and further assisting in neural image processing of deeper parts of the human body. - Replication and application of a time-varying pulsating uniform and / or non-uniform electromagnetic field. - Read in real time the characteristics and parameters of signals obtained from the nervous system, other tissues, or any organ, and apply signals that are the same as or significantly different from those read from the patient's nervous system, other tissues, or any organ. - Measurement of electromagnetic fields (EMF) before and during treatment application using sensors that can be SQUID sensors, as well as other sensors that measure physiological and electrophysiological data, tissue characteristics, and other characteristics of other cells. - The device may be portable and may be worn by the patient for several hours each day. - Measure the electromagnetic field when the patient performs a cognitive task or any other passive activity to more accurately determine where defects are occurring within the nervous system, other tissues, or any organ, and based on the signals received from the sensors, concentrate the treatment on the defective parts of the nervous system, other tissues, and any organ. - Use a built-in feedback loop between paired sensors and emitters, and the treatment protocol is automatically corrected upon its application. - Combine electromagnetic field treatment with cell transplantation through electromagnetic conduction and / or guidance of stem cells or other cells within the tissue, isolate target cells from the patient's blood / plasma / cerebrospinal fluid and culture them in cell culture, and then apply EMF to design an individualized treatment protocol, i.e., determine the optimal intensity and frequency required for EMF application.
[0037] According to one embodiment of the present invention, a protocol for treatment by a constant or time-varying uniform and / or non-uniform electromagnetic field is automatically generated by the system. The treatment protocol may be input into the treatment system, and the treatment system includes an apparatus for generating a vibrating time-varying uniform and / or non-uniform electromagnetic field that can be applied to the whole body or a body part of a patient. (References to electromagnetic in this specification refer to time-varying magnetic fields generated by an electromagnetic generator configured to generate an electromagnet or a time-varying pulsating electromagnetic field including intensity, direction, frequency, amplitude, and type.) The vibrating electromagnetic field is characterized by frequency and amplitude, type, intensity, or strength. As used herein, the terms "strength" and "amplitude" represent the amplitude, maximum value, average value, root mean square, or other characteristic or representative value indicating the intensity of the applied electromagnetic field, or are used interchangeably to characterize the spectrum of a measured nerve or other tissue / organ activity signal. The treatment protocol may define the frequency, amplitude, strength, and intensity of the applied electromagnetic field, as well as one or more other characteristics of the electromagnetic field (e.g., the duration of each application of the field, the type of electromagnetic field such as a uniform or non-uniform field, the number of applications, the interval between applications, or other characteristics). The treatment protocol may define two or more electromagnetic fields of different frequencies, strengths, and types that can be applied to the patient in a defined sequence (e.g., simultaneously or at different times).
[0038] The treatment system may be configured to include an interface for receiving information about the patient. The information may include clinical data along with a description explaining one or more impaired functions of the patient and any other co-existing diseases. In particular, this description may explain an impaired functionality known or suspected to be related to the impaired function of the nervous system or other tissues of the patient affected by injury, inflammation, or ischemia. For example, the clinical data may be input by a medical professional based on a patient examination, or based on the patient's declaration and past medical history.
[0039] In addition, the received information includes the results of measurements of the patient's nervous system function at various locations in the nervous system (e.g., by sensors placed at various locations on the patient's skin or other locations). The measurements can include an array of sensors configured to be placed at known locations with respect to the patient's brain, spinal cord, other components of the patient's nervous system, or other tissues affected by injury, inflammation, or ischemia. For example, these sensors can include electroencephalogram (EEG) recordings, magnetoencephalogram (MEG) recordings, electroneuromyogram (EMNG) recordings, or other types of sensors designed to measure physiological and electrophysiological data, tissue, other cells, and organ characteristics. According to a preferred embodiment of the present invention, the sensors include impedance sensors, temperature sensors, magnetic field sensors (such as SQUID sensors or Hall effect sensors), electric field or shock sensors. Such information from the sensors can be directly input into a communication module, machine learning software, or a main database for storage and analysis, or can be input by a user, for example, as text or as a medical code (e.g., selected from a menu).
[0040] Sensor measurements can be obtained from a patient simultaneously with a treatment session that includes the continuous application of one or more stimuli. As used herein, a stimulus can be actively applied by the patient. For example, the patient can perform a spontaneous physical task (e.g., a rest state, movement of a limb or body part, resisting movement of a limb or body part, speaking, controlling breathing, looking at an object, or another active physical task), a cognitive task (e.g., a rest state, imagining a situation, thinking about a particular topic, attempting to solve a problem, focusing on a selected sensory input, or another active cognitive task), attempting to perform a physical task (e.g., focusing on moving a limb that is paralyzed, severed, or restrained), or performing a spontaneous or active task. A stimulus can be applied by an external agent while the patient remains in a passive state. For example, a patient's limb or body part can be moved by an external agent (e.g., by another person or by a machine), the patient can receive sensory input, or can be otherwise passively stimulated. A stimulus can include observing an action performed by another person (e.g., directly or recorded), or an action using an animation on a screen, a virtual reality device, or otherwise. The application of a stimulus can include the simultaneous (or alternating) application of two or more different stimuli. The active or passive application of a stimulus is interchangeably referred to herein as the performance of a task.
[0041] Sensor measurement data can be analyzed to obtain a set of processed data (e.g., the amplitude, frequency, strength, and intensity of an electromagnetic field, temperature, physiological and electrophysiological data, and the electrical impedance, permittivity, or magnetic permeability of a particular tissue type or organ, and other cellular properties of tissues). For example, each set of data can represent measurements by a sensor (or in some cases, by a group of two or more sensors) during the application of a particular stimulus or multiple stimuli. Alternatively, or in addition, measurements obtained during the application of a particular stimulus can be marked or labeled with the identification of that stimulus.
[0042] In some cases, the analysis may involve distinguishing relevant parameters based on statistical analysis using AI, machine learning, or deep learning software. For example, such machine learning may identify correlations between the characteristics of one or more measured electromagnetic fields and the application of a specific electromagnetic field within a particular region of a patient's body. Such analysis may be based on patient data acquired currently or previously, or may be based on an analysis of a group of patients characterized, for example, by sharing similar clinical characteristics, such as common features of medical history.
[0043] One or more measured biophysical signals may be identified that are related to or associated with an instructed impaired functionality or pathological event of the nervous system or other tissue affected by a patient's injury, inflammation, or ischemia. For example, the impaired functionality may be identified or suspected based on received clinical data (e.g., symptoms reported by the patient or the patient's family or acquaintance, symptoms noted during examination or observation by a medical professional, symptoms obtained by medical tests, or something else), or the pathological event may be identified or suspected based on received sensor measurements or performed pathological analysis.
[0044] The measured neural activity, or the electrical activity of cells within other tissues, in each identified electromagnetic field can be organized to generate a spatial activity map. For example, the spatial position of the measured electromagnetic field can be determined by the identification information of the sensor used for the measurement of that electromagnetic field. The spatial map can indicate the electromagnetic field of the neural activity, or the electrical activity of other cells, at each mapped position. As used herein, the spatial position may refer to a location on or within the patient's body or to the location of a particular sensor. The mapped neural activity, or the activity of other cell types, may be presented in the form of a spatial activity map or in some other form (e.g., as coordinates or sensor identifiers and a particular set of results) and may include values derived from one or more electroencephalogram spectra or correlations between two values or one or more quantities.
[0045] One or more corresponding reference baseline treatment protocols and corresponding one or more reference sensor and emitter positioning maps can be retrieved from a main database or other data storage facility. The reference baseline treatment protocols and the positioning maps can be retrieved based on any or all of the following parameters, including but not limited to, the same disease or condition, symptoms, and affected tissue or organ. Each baseline treatment protocol, as well as the sensor and emitter positioning map, can indicate a representative electromagnetic field for either a healthy nervous system or other tissue (e.g., based on measurements of a subject determined to have a functioning nervous system or other tissue without dysfunction) or a nervous system or other tissue affected by injury, inflammation, or ischemia that is known to be defective in function in a known manner, or values of other biophysical, biochemical, or biological parameters, as well as a reference range of intensities and frequencies of electromagnetic fields to be used for optimal therapeutic effect on each organ or tissue depending on the general or target cell type.
[0046] Each of the retrieved reference sensor and emitter positioning maps can be compared to a corresponding generated sensor and emitter positioning map (based on readings of biophysical signals of the nervous system or other tissues affected by injury, inflammation or ischemia). Comparison of the calculated regions of variation of the electromagnetic field and skin impedance for the reference sensor and emitter positioning maps can indicate regions where the generated sensor and emitter positioning maps indicate malfunction or ongoing pathological events. For example, one or more locations in the comparison of the reference sensor and emitter positioning map to the generated sensor and emitter positioning map can indicate the level of function in a spatial region that deviates from the reference sensor and emitter positioning map representing a healthy nervous system, or the level of function in a spatial region similar to the reference sensor and emitter positioning map representing a dysfunctional neural network.
[0047] When one or more locations on one or more generated sensor and emitter positioning maps indicate malfunction, a treatment protocol can be generated. The treatment protocol can be input into a portable device for generating a treatment electromagnetic field. The treatment protocol may specify one or more time-varying characteristics of the treatment electromagnetic field to be applied to a patient. The treatment protocol can be automatically input into the electromagnetic field generator by, for example, a computer, or can be selected or input by a user based on, for example, a baseline or personalized treatment protocol. When the treatment protocol is input into the electromagnetic field generator, it causes the electromagnetic field generator to generate a sequence of uniform and / or non-uniform electromagnetic fields that vary over time, characterized by their intensity, direction, frequency, amplitude, and type, with a reference electromagnetic field range predefined for each organ and cell type. The treatment protocol can specify other characteristics of the field sequence. These characteristics can include one or more of the field strength or amplitude, duration, order of application of fields of different frequencies, interval between applications of different fields, number of applications of each field, or other parameters. The treatment protocol can be applied to the patient's entire body or to a part of the patient's body such as the head, neck, spinal cord, or one or more of other tissues.
[0048] Each identified electromagnetic field can be associated with a particular neural network or other tissue. As used herein, a neural network includes the components of the nervous system that are associated with a particular functionality of the nervous system. Typically, a response to a particular stimulus or performance of a particular task can involve two or more different neural networks.
[0049] The reference electromagnetic field ranges and patient skin impedances determined for each connective tissue, neural tissue, immune system, muscle tissue, and organ may have been previously derived from an analysis of measurements made on a population of subjects, including in some cases the patient currently being treated.
[0050] To detect the location of trauma in other parts of the nervous system, a skin impedance sensor is used, by which different types of hematomas in all parts of a patient's nervous system, organs, or other tissues can be detected.
[0051] For example, the group may include both healthy individuals who appear to have a fully functional nervous system and individuals determined to have a malfunctioning nervous system in a known manner. In some cases, it may include subjects who appear to be fully functional but may have defects in one or more neural networks (e.g., other neural networks compensate for the defect). The results of comparing various measurements may indicate the characteristics of the electromagnetic fields and skin impedance associated with each functionality, and thus each neural network or other tissue. Spatial mapping over the nervous system or other tissues of nervous system activity (e.g., one or more of the brain, spinal cord, or other major nerves) may indicate regions of the nervous system or tissue where deviations in neural activity are associated with specific defects in the function of a particular neural network or other tissue.
[0052] A neural activity profile can be obtained based on neural function measurements performed on a person or group. A neural activity profile characterizes the neural activity of a person (a patient, a person within a control group, or another person) or a group (for example, after averaging or applying other statistical operations to measurements made on individuals within the group). A neural activity profile may be based on EEG, MEG, or other measurements made on the brain or other parts of the nervous system of one or more human subjects. For example, sensors similar to MEG sensors, or sensors similar to EEG sensors or other sensors, may be used to measure neural activity in the brain, spinal cord, or other parts of the nervous system. As used herein, MEG or EEG measurements refer to measurements of any part of the nervous system using sensors similar to MEG or EEG sensors, respectively. Similarly, MEG or EEG sensors, as used herein, refer to sensors that function in a manner similar to MEG (which senses magnetic fields) or EEG (which senses electric currents or voltages), regardless of whether the sensor is intended to measure brain activity or the activity of another component of the nervous system.
[0053] Measurements, particularly EEG, MEG, EMNG, or similar measurements, can be interpreted as resulting in a map of measured neural activity at multiple distinguishable locations within the nervous system. For example, EEG or MEG sensors, or other local sensors, can be placed at a set of predetermined locations on a person's head, back, or another location where neural activity occurs (for example, near an active organ or limb, near a sensory organ, or other location), or any combination of the above, to obtain a spatial map of neural activity. The location of the measured local neural activity can be derived from the location of the sensor that measured the local activity or from the sensor. In some cases, when local neural activity is measured by multiple sensors, triangulation or other techniques can be applied to determine the location of the measured local activity relative to the known locations of the sensors. In addition, measurements (for example, functional magnetic resonance imaging (fMRI) or other measurements) can be interpreted as indicating the activity of the entire brain.
[0054] Measurements can be performed when the nervous system of each subject is activating a specific nerve function. For example, the nerve function can be associated with the subject performing one or more tasks. The tasks can include resting (e.g., for the purpose of establishing one or more baseline measurements of nerve activity for comparison to other measured nerve functions), performing one or more active (e.g., voluntary movement of a limb, facial feature, or other body part by the patient) or passive (e.g., a body part is moved by another person, machine, or other external agent) motor activities or movements, performing one or more active or passive cognitive tasks (e.g., object recognition, memory retrieval, problem solving, or other cognitive activities), performing automatic tasks (e.g., receiving environmental conditions, sensory inputs, or other stimuli that activate the autonomic nervous system), or performing other tasks. The components of the nervous system whose activity changes from the baseline level during task execution are referred to herein as the neural network associated with the task and nerve function.
[0055] A master database including representative nerve activity profiles and profiles of other tissue or organ activities, including the reference electromagnetic field ranges for each organ and cell type, can be generated by performing measurements on a population of subjects. Each reference electromagnetic field range is determined by frequency, amplitude, intensity, and strength. The population of subjects can include individuals who are determined to be generally healthy (e.g., determined by the absence of known defects or trauma in the nervous system or other tissues) and whose nervous system, or other organ and tissue of interest, is determined to be healthy. In some cases, the population can be divided into subpopulations (e.g., divided by age, gender, or other characteristics known or suspected to affect the nerve activity profile). The nerve activity profiles and profiles of other tissue or organ activities determined for a population assumed to be healthy are referred to herein as reference profiles.
[0056] In some cases, it may be suspected that there is a malfunction in the patient's neural network or other tissues. For example, such a malfunction may be suspected after a stroke, trauma, disease, disorder, or other event that may or may be suspected of causing injury to one or more components of the nervous system or other tissues as a result. As another example, a patient may report or be observed to have difficulty performing one or more tasks such that a malfunction of the neural network may be suspected.
[0057] When a malfunction of the neural network is suspected, a series of neural activity measurements may be performed on the patient. For example, MEG, EEG, EMNG, or other measurements of neural activity may be performed on the patient while the patient performs a series of tasks. The series of tasks may include a complete set of tasks used to obtain a complete neural activity profile of the patient. Alternatively, the tasks performed may be limited to a subset of tasks that are relevant to a particular suspected neural network defect or that would be effective in facilitating the diagnosis of a defect within a particular neural network.
[0058] The obtained neural activity profile of the patient can then be compared to a reference profile. The reference profile can include a standard profile for all individuals or can be characteristic of a subset. For example, the reference profile can be specific to one or more of a particular age group, gender, racial or ethnic group, work or educational history, or other subset defined in some way. In some cases, the comparison can be limited to frequencies characteristic of or suspected to be related to a particular suspected defect. For example, a treatment system can be configured to extract an electromagnetic field determined to be characteristic of the electrical activity of one or more neural networks or other cell groups. In this comparison, it can then be checked whether the measured neural activity differs from a reference neural activity profile retrieved from a main database containing the reference profile or an electrical activity profile of other cells in one of the identified characteristic electromagnetic fields. For example, this comparison can show that the spectrum of neural activity associated with a particular neural network measured for the patient can differ from the reference neural activity profile for that neural network at those locations in one or more locations. The difference can be quantified. For example, the difference score for each neural network can be a function of the difference between the measured neural activity profile and the corresponding reference neural activity profile. For example, the difference score can be expressed as a ratio or percentage of normal neural activity for each neural network. The same difference score can also be obtained for the electrical or other biological activity of other cells in the diseased tissue or organ.
[0059] This comparison can lead to one or more proposed treatment protocols for electromagnetic therapy to correct identified defects within one or more neural networks or other tissues. For example, a treatment protocol can specify the frequency and intensity or frequency spectrum and intensity spectrum of a time-varying electromagnetic field for treatment that can be applied to a patient. A treatment protocol can specify the location on the patient's body where the specified treatment electromagnetic field is to be applied, or can specify that the electromagnetic field is to be applied to the entire brain, a particular body part, or the patient's entire body. A treatment protocol can specify the amplitude of the treatment electromagnetic field, or another quantity related to the intensity of the treatment electromagnetic field to be applied. A treatment protocol may be one that specifies the type of treatment electromagnetic field to be applied (e.g., uniform and / or non-uniform). A treatment protocol can specify the duration of exposure to the treatment electromagnetic field. A treatment protocol can specify the number of treatment sessions, the interval between subsequent treatment sessions, or can define a series of treatments in some other way. If treatment is required for two or more neural networks or tissues, the treatment protocol can specify the application of treatment to different neural networks and tissues (e.g., at the frequencies of two or more fields). For example, a treatment protocol can specify the order of treatment, such as the order of application of electromagnetic fields having different types of said fields or intensities, the interval between successive applications of different electromagnetic fields, or other parameters related to the treatment of different neural networks or tissues.
[0060] The treatment protocol may specify the results of readings of monitored biological, biophysical, or biochemical sensors that may indicate the effectiveness of the treatment. During the treatment session, the treatment protocol may then be automatically modified according to, and simultaneously with, the readings of the monitored biological, biophysical, or biochemical sensors. The treatment monitoring unit of the treatment system, or the protocol generation system, may comprise one or more sensors whose measurements may indicate the activity in the neural network and other tissues, or in one or more parts of the nervous system or other organs. For example, the readings of the monitored biophysical sensors may include the effects of injury, inflammation, or ischemia, such as those indicated by electromagnetic fields, tissue impedance, the temperature of the area, and skin conductivity (e.g., an increase in local temperature indicates an increase in local blood flow, which in turn indicates an increase in local brain activity) in the area of the brain or nervous system or other tissues being monitored. Alternatively, or in addition, other sensors may be used. Such other sensors may include, for example, an electrocardiogram (ECG) sensor, an EEG or MEG sensor, an EMNG sensor for the electrical measurement of muscle activity, a near-infrared sensor, a blood content analyzer, or one or more other types of sensors. The sensors may include one or more sensors configured to measure the movement of the patient's body. For example, such motion sensors may include remote motion sensors (e.g., based on ultrasound, electromagnetic waves or pulses, or others), virtual reality (VR) sensors (e.g., VR gloves, full or partial VR suits, or other VR sensors), light-emitting elements or reflectors attached to the patient and recorded by one or more imaging devices, or another type of motion sensor. Sensors configured to be placed on or near the patient's body, for example, within the applied treatment electromagnetic field, may be configured to operate within the magnetic field (e.g., designed to be used on the patient's body placed within the magnetic field of an MRI device during combined use with magnetic resonance imaging (MRI)).Alternatively, or in addition, the treatment system may be configured to apply the treatment field intermittently (e.g., with periodic interruptions during which the magnetic field is not applied), and the sensor is configured only during interruptions in the operation of the field.
[0061] For example, a baseline treatment protocol may indicate the duration, frequency, type, and extent of the reference electromagnetic field applied based on representative results, theories, or any other form of typical expected response to treatment throughout preclinical and clinical trials. However, the response may vary for each individual patient. Thus, during application of the treatment electromagnetic field, temperature maps, activity maps, or other monitoring results of the patient's head or nervous system may be obtained, for example, using a thermal camera or other sensors. For example, the measured temperature may indicate whether activity has increased as a result of treatment in the region of the nervous system associated with the neural network being treated (e.g., a part of the brain that is expected to increase in activity as a result of treatment due to recovery of the neural network that responds to stimulation by the applied field).
[0062] The treatment system can be configured to adjust or modify a baseline treatment protocol according to the readings of one or more monitored biophysical sensors using a built-in feedback loop system. For example, if the monitored electromagnetic field increases to a level indicating improvement in the function of a neural network or other tissue, treatment with the electromagnetic field characteristic of that neural network or tissue may be stopped (e.g., for the remainder of the current treatment session, or some other period) or reduced (e.g., by reducing the amplitude, frequency, intensity, or duration). Thus, the baseline treatment protocol can be modified until the sensor measures an electromagnetic field within the reference electromagnetic field range for that tissue or organ, or other biophysical signal within its reference range. If an activity profile corresponding to the reference electromagnetic field range, or other reference range of measurements, is not measured, the treatment protocol may be stopped and the patient may be required to report to a healthcare facility or clinic for a check-in. Subsequently, it may continue with generating a new placement map, or reprogramming the sensor and emitter to continue a conservative treatment protocol where the sensor begins to record the response pattern of the tissue during the applied treatment. If the cell activity pattern does not show changes over time, the treatment protocol can be adjusted to emit an electromagnetic field within the reference electromagnetic field range, taking into account the natural resonance frequency of a particular cell type, to induce electromagnetic induction in the surrounding tissue and achieve synchronization of cell activity with the reference electromagnetic field range. In addition, a new sensor and emitter placement map may be generated and the baseline treatment protocol may be followed until changes in the sensor readings are observed.
[0063] The application of a temporally varying non-uniform electromagnetic field for therapy can facilitate the regeneration or functional recovery of neural networks and other organs or tissues. The non-uniform electromagnetic field affects the interactions between cells, as well as the interactions between cells and the extracellular matrix, the interactions between cells and nerve fibers, and also affects the nature of the field around neurons. Since the non-uniform electromagnetic field is similar in nature to the endogenous electromagnetic field within the human body, the non-uniform electromagnetic field reduces the negative components of the inflammatory response that cause neuron damage and damage to other tissues or organs, and promotes tissue regeneration. By causing deformation of embedded ion channels, changing their activation kinetics, and reorganizing the ion distribution around the cell membrane as well as within the intracellular and extracellular spaces, the non-uniform electromagnetic field can control the opening and closing of voltage-dependent ion channels, change the binding rates of ions and ligands, and even cause electromagnetic induction. This, in turn, changes the dynamics of cell activation, migration, activity, and division. Alternatively, in these cases where these fields cause functional disorders in the living body and contribute to ongoing pathological events, these fields may also reduce cell activity and cell division.
[0064] The differential score for each neural network, or other cells of interest, can be presented to the operator of the system. A physician or other medical professional can examine the differential score. In some cases, the protocol generation system can be configured to automatically determine a baseline treatment protocol. In some cases, the protocol generation system can be configured to automatically transmit the baseline treatment protocol to the treatment system. The treatment system can be configured to generate one or more electromagnetic fields according to the transmitted protocol (for example, when a human operator instructs that treatment should be applied to a patient for whom a baseline treatment protocol has been generated).
[0065] Next, the system healthcare provider determines whether treatment is necessary and may prioritize one or more applications of the treatment protocol proposed by the system for treatment of one or more neural networks or other tissues. The determination of the treatment protocol by the medical expert may be based on the patient's initial clinical examination, in addition to the patient's preferences, the degree of damage to each neural network or tissue, the patient's medical history, time constraints, or other information or criteria. In determining the order of treatment of different neural networks or other tissues, factors such as the patient's needs and preferences, the estimated time required to treat each neural network, the need for treatment (as indicated by, for example, a difference score in combination with other considerations), past success, or other considerations may be taken into account.
[0066] The system of the present invention combines electromagnetic field therapy in combination with stem cell transplantation to induce electromagnetic conduction of stem cells or other cells within a tissue, separates target cells from the patient's blood / plasma / cerebrospinal fluid, cultures them in cell culture, and then applies electromagnetic field therapy to design a personalized therapy, i.e., to determine the optimal intensity and frequency for stimulating / regenerating cells in some regions of the brain or any body part or tissue, and can be used for this purpose. The magnetic properties of the system can also be used to guide labeled cells to the desired location within the body, i.e., to magnetically guide stem cells or other cells intended for transplantation to initiate tissue regeneration through the release of growth factors or to functionally replace cells with impaired function, enabling differentiation into other cell types in the target organ or tissue. Furthermore, this system enables targeted drug therapy by electromagnetically guiding drugs to the desired location and can be used to facilitate their rapid release and action.
[0067] The fixed device is generally installed in a specialized institution (such as a hospital, clinic, etc.), through which trained medical staff can configure the therapy for the patient, calibrate the portable device, and even remotely control the operation of the portable device that the patient can take home to prevent misuse of the device by the user.
[0068] Another possible embodiment of the present invention is to create a dedicated electromagnetic therapy that staff / patients can briefly attempt to combat infections that occur within a hospital (during surgery, pandemics, etc.), and further provide a general boost to the immune system of patients who are immunologically compromised or have some form of autoimmune disease, by installing on the inside a wall with a plurality of electrodes.
[0069] Cancer or tumor treatment therapies for patients can also be achieved using the system of the present invention, by the action of an electromagnetic field of the same frequency or opposite sign from that previously measured from the cancer cells themselves through our sensors (such as SQUID / Hall effect), the aim being to destroy / weaken the tumor or cancer cells by inhibiting division, reducing their activity, and further enhancing their recognition by cells of the immune system through MHC antigen processing and presentation, and further upregulation of their expression. Also, such an application can be used in combination with radiation therapy to improve the effects of radiation, reduce many negative outcomes, and act as a kind of mitigation of the harmful effects of radiation therapy in patients. Furthermore, this system can also be used in combination with chemotherapy to improve the patient's health condition and further enhance the function of the immune system.
[0070] Electromagnetic fields can be used to modify cellular signals and factors associated with the activation of danger signals within the cells of the human body, particularly those of our immune system. These have the ability to induce reorientation of molecules within the cell, cause deformation of embedded ion channels, change their activation kinetics, thereby reducing or enhancing cellular activity. Electromagnetic fields can also cause rearrangement of the ion distribution around the cell membrane as well as within and outside the cell space, resulting in cell polarization and further controlling the opening and closing of voltage-dependent channels. These can also change the rate of ion and ligand binding, amplify or attenuate signal propagation and even electromagnetic induction, i.e., increase the current in specific parts of the body where the field is not applied, further amplifying the intracellular signal transduction cascade. Moreover, these are also non-invasive modalities, more economical and safer compared to drugs and surgery and have the potential to reach a larger number of patients and medical experts.
[0071] Two major mechanisms of action of electromagnetic fields are the regulation of cell adhesion by changes in external charges on the cell, and changes in the rate and nature of both intracellular signal transduction and communication between cells themselves as well as between cells and the extracellular matrix. Depending on the frequency and nature of the field of interest, target cells can trigger or completely suppress anti-inflammatory or inflammatory responses.
[0072] By acting on major histocompatibility complex II (MHC II), major histocompatibility complex I (MHC I), as well as heat shock proteins (HSPs), adenosine triphosphate (ATP), interleukins, and other molecular mediators, electromagnetic fields can improve antigen recognition by immune cells, delay or accelerate the immune response, and even initiate tissue regeneration. Interestingly, as recent research has suggested, some of the lung damage in COVID-19 patients may also be caused by an overactive immune response, and thus it may also be important to suppress the immune response by targeting the immune response at specific field frequencies. In this case, the systems and methods of the present invention can be used as a monotherapy to alleviate the symptoms of this disease or any other infectious disease, or in combination with a developed vaccine or pharmaceutical used to alleviate symptoms, or transplanted stem cells or any other cells. Furthermore, the systems and methods of the present invention can cause inhibition of the inflammatory response by reducing the levels of inflammatory cytokines, and can further reduce the recruitment of inflammatory cells to the lungs or other organs affected by the overactive immune response. Additionally, if stem cell transplantation is performed prior to the administration of the electromagnetic field, the systems and methods of the present invention are not only used to reduce the inflammatory immune response, but its magnetic properties can also be used to direct labeled stem cells to the desired site to cause functional regeneration of the affected organ.
[0073] One or more coils can be operated to generate one or more temporally varying electromagnetic fields according to a selected treatment protocol. The electromagnetic field can be applied to a selected section of the body (e.g., the head, torso, thorax, abdomen, limbs, or all or part of another section of the body) or to the entire body of the patient.
[0074] By measuring tissue impedance via an impedance sensor, the site of inflammation / defect within the tissue can be determined more rapidly and accurately, and the information from the sensor can help detect different types of hematomas on the patient's tissue.
[0075] A treatment protocol generation system is configured to generate a patient's baseline treatment protocol, which can be updated in real time simultaneously with the reading of biophysical signals, resulting in a personalized baseline treatment protocol. The treatment protocol generation system may include a treatment system and be separated from a system configured to apply a treatment electromagnetic field to a patient. In some cases, the protocol generation system may be configured to communicate with a separate system that includes the treatment system. In some cases, the protocol generation system may be incorporated into a single protocol generation and treatment system that includes the treatment system, or the protocol generation system may incorporate the treatment system.
[0076] The protocol generation system may comprise an array of sensors 500 or communicate with an array of sensors 500. The array of sensors 500 may include one or more types of sensors configured to measure one or more types of neural activity, temperature, tissue impedance, permeability and permittivity, and electromagnetic fields as well as a number of other biophysical, biological or biochemical parameters.
[0077] A protocol generation and treatment system based on the simultaneous reading of biophysical signals At least one patient personal folder containing medical patient data, a plurality of baseline treatment protocols, each baseline treatment protocol including a positioning map of one or more associated reference sensors 500 and emitters 400, each baseline treatment protocol being associated with a specific disease or disorder, or an instructed impaired functionality of a nervous system, organ, or other tissue affected by a patient's injury, inflammation, or ischemia, each baseline treatment protocol being associated with a reference range of electromagnetic field intensities and frequencies provided to result in an optimal treatment effect for each organ or tissue, depending on the general or target cell type, and a main database configured to store the plurality of baseline treatment protocols Compare the data of a medical patient with data from similar baseline treatment protocols, extrapolate one or more baseline treatment protocols associated with a particular disease or an indicated impaired functionality, provide a positioning map of one or more reference sensors 500 and emitters 400 associated with the baseline treatment protocols, check which of the positioning map and the baseline treatment protocol are suitable for the patient considering the readings of biophysical signals, and modify the positioning map and the baseline treatment protocol considering the readings of biophysical signals to make a personalized positioning map and treatment protocol, and a machine learning software and a processor configured as such, An electromagnetic field generator configured to generate a constant or time-varying pulsating electromagnetic field including intensity, direction, frequency, amplitude, and type, a power source for components of the portable device 100, an array of sensors 500 configured to measure biological, biophysical, and biochemical signals including the electromagnetic field, an array of emitters 400 configured to apply the electromagnetic field, record the readings of biophysical signals from each of the array of sensors 500, and compare the readings of biophysical signals with a reference electromagnetic field range to identify one or more of a plurality of biophysical signals corresponding to a particular disease or an indicated impaired functionality, and a portable device 100 comprising a computing unit 104 configured as such, wherein each baseline treatment protocol defines the characteristics of the time-varying pulsating electromagnetic field applied through each of the array of emitters 400, the portable device 100, A fixed device 200 comprising a machine learning software, a processor, and a communication interface, wherein the fixed device 200 is configured to calibrate the portable device 100, inspect an array of sensors 500 and emitters 400 for accuracy, store a baseline treatment protocol within a storage area of the portable device 100 before patient use, and store information including data collected from an array of nerve activity sensors worn by a patient during a session of applied stimulation and data collected from an array of sensors 500 worn by the patient during treatment application.
[0078] The treatment protocol generation method may be executed by the computing unit 104. The treatment protocol generation method may be executed when an array of sensors 500 is positioned to measure an electromagnetic field, temperature, and patient skin conductivity. The acquired measured biophysical signals may include data for different regions of the nervous system, any tissue or organ, and data while the patient is performing different tasks or undergoing different sessions of applied stimulation.
[0079] The acquired measured biophysical signals may be analyzed to calculate the electromagnetic field range of one or more measurements of the acquired recorded biophysical signals. For example, each measured biophysical signal detected by each sensor 500 (or by a group of two or more sensors) may be spectrally analyzed to yield a set of electromagnetic fields, for example, at the location measured by each sensor 500 or group of sensors 500 (at a single or adjacent location, along a single nerve, or in some other way representing a location within the nervous system where signals are expected to be generated) to characterize the nerve activity of a neural network of any other cell type, or the electrical activity of any other cell type. Separate electromagnetic fields may be calculated for each applied stimulation and for each location of the sensors 500.
[0080] Next, the treatment system is operated according to a baseline treatment protocol, and the electromagnetic field generator can generate the reference electromagnetic field range for each organ / cell type.
[0081] The baseline treatment protocol can be generated by selecting a previously designed treatment protocol from a main database of previously designed baseline treatment protocols. Each baseline treatment protocol is associated with a positioning map of one or more reference sensors 500 and emitters 400 and a reference range of electromagnetic field intensities and frequencies provided to achieve an optimal treatment effect for each organ or tissue, depending on the general or target cell type. As another example, the treatment protocol can be generated based on an identified subset and further based on other factors (such as derived from clinical data). For example, the order of application of different types of electromagnetic fields, or the relative treatment duration for each neural network, tissue, or organ, can be determined by the severity of the deviation from normal function, the patient's needs or preferences, or the urgency of treatment for each neural network, tissue, or organ based on other criteria.
[0082] In some cases, multiple baseline treatment protocols can be generated. For example, several different baseline treatment protocols are generated, from which a medical professional can select one for application during treatment and a positioning map of one or more reference sensors 500 and emitters 400. After obtaining measurements from the biophysical signals from the array of sensors 500, the healthcare provider may choose to select a positioning map of one reference sensor 500 and emitter 400. The generated baseline treatment protocol can be made available for use in the portable device 100. The generated baseline treatment protocol can be made available for use on a location on the patient's body or for use on the patient's entire body.
[0083] The baseline treatment protocol may be specified to define a sequence of electromagnetic fields to be applied. Each applied electromagnetic field may be characterized by one or more frequencies, properties, durations, and amplitudes, or by other characteristics. The baseline treatment protocol may indicate an order of application of different electromagnetic fields, a frequency of application, an interval between successive applications, or other characteristics. Each baseline treatment protocol may be associated with an evaluation that can be considered by a healthcare provider when selecting between two or more proposed baseline treatment protocols. The selected baseline treatment protocol may be applied (e.g., automatically or manually) when operating the portable device 100 to treat a patient. The application of the baseline treatment protocol may be modified during the application of the treatment electromagnetic field to the patient. For example, the patient may be monitored during the application of the treatment via one or more monitoring sensors or an array of sensors 500. The application of the treatment electromagnetic field of each of the array of emitters 400 may be modified according to the measurement of the resulting biophysical signals from each of the array of sensors 500 (e.g., by changing the duration, amplitude, frequency, property, or other characteristics of the applied field), and each particular emitter 400 is positioned in close proximity to each particular sensor 500, and the emitter 400 and sensor 500 operate as a pair.
[0084] The treatment protocol generation method may be repeated after the application of the treatment electromagnetic field. For example, the treatment protocol generation method may be re-executed when the effectiveness of the treatment is to be evaluated.
[0085] The portable device 100 is operable to apply a constant or time-varying pulsating electromagnetic field through each of the arrays of emitters 400 and simultaneously acquire measurements of biophysical, biochemical, or other biological signals from each of the arrays of sensors 500. The computing unit 104 is further configured to modify in real time the time-varying pulsating electromagnetic field of each of the arrays of emitters 400 positioned within a particular region of the patient's body based on measurements from each of the arrays of sensors 500 positioned near each of the arrays of emitters 400. The type, intensity, frequency, direction, and magnitude of the time-varying pulsating electromagnetic field of each of the arrays of emitters 400 are modified to apply at least a reference electromagnetic field within a range characteristic of a particular region of a healthy individual's patient body. Thus, each of the arrays of sensors 500 positioned near each of the arrays of emitters 400 is configured as a pair operating by a feedback loop control system. When the properties of the measured electromagnetic field around neurons, other tissues, or organs change significantly or some abnormality is detected, the portable device 100 automatically reduces, increases, or completely stops the application of all or some of the electromagnetic fields of the arrays of emitters 400. The baseline treatment protocol can always be modified simultaneously with the reading of the biophysical signals from each of the arrays of sensors 500. Thus, each update of the baseline treatment protocol results in a personalized treatment protocol.
[0086] The time-varying pulsating electromagnetic field of each of the arrays of emitters 400 can be set to apply a reference electromagnetic field characteristic of a particular region of the patient's body of a healthy individual, or to apply an electromagnetic field that matches the measurements obtained from each of the arrays of sensors 500, or to apply a significantly different signal measured from the patient's tissue / organs, or to apply an electromagnetic field characterized by a different waveform (as opposed to that measured by sensor 500) to cause destructive or partially destructive interference. In this case, the waveform of the applied signal must be different from that measured by sensor 500, and partial or complete destructive interference can be achieved by varying the frequency and amplitude of the applied electromagnetic field.
[0087] A "significantly different signal" refers to a signal having a different amplitude, frequency, intensity, and / or a different waveform. The term "waveform" refers to periodic waveform types (sine wave, square wave, triangular wave, sawtooth wave, ramp-up wave, ramp-down wave, square wave, pulse wave, rounded pulse wave, circular pulse wave, triangular pulse wave, ramp pulse wave, sine cubed wave, frame, half-circle wave, and all variations of these waveforms), inverse waveform types of the above waveforms (inverse sine wave, inverse tangent wave, inverse cosine wave, and inverse square wave, inverse triangular wave, inverse sawtooth wave, etc.), and random waveform types that are not necessarily periodic.
[0088] When applying "different waveforms", the inverted / opposite waveform of the waveform being read by the sensor can be applied, or a completely different waveform from the above list can be applied (for example, while reading a sine wave, applying a tangent wave or a square wave). If the goal is to achieve some form of constructive or destructive interference, the portable device 100 operates with variations of the same waveform type using the actual waveform (constructive interference) or its opposite (destructive interference). For example, if the shape of the acquired signal is a sine wave and the goal is to achieve constructive interference, an electromagnetic field with a sine-wave shape is applied. On the other hand, if destructive interference was to be achieved, the inverse sine waveform is applied as it is the opposite waveform of the sine wave, and this is the same for each waveform. If the read signal is a square wave, constructive interference is obtained by applying a square wave, and destructive interference is obtained when the inverse square wave is applied.
[0089] Partially destructive or partially constructive interference can be obtained when the same or opposite waveforms of different amplitudes or frequencies are applied. Further, according to the proposal of machine learning software, waveforms completely different from the initial waveform (sine wave - square wave) can be applied if the goal is not to achieve a specific value of interference.
[0090] The type of time-varying pulsating electromagnetic field applied through each of the arrays of emitters 400 can be uniform and / or non-uniform.
[0091] The nerve activity sensor can be incorporated within the fixed device 200. For example, the nerve activity sensor can be placed in a hospital, clinic, rehabilitation center, or open environment, or it can be portable or transportable to the patient's location. The nerve activity sensor can also be incorporated within the portable device 100 within the array of sensors 500.
[0092] For example, the neural activity sensor may include an array of MEG sensors. Each MEG sensor may be configured to measure a magnetic field resulting from an electric current generated by neural activity in the brain. Typically, each MEG sensor measures a magnetic field generated from within a region of the brain near that MEG sensor. Thus, measurements by the array of MEG sensors may provide a spatial map of neural activity in the brain.
[0093] The neural activity sensor may include EEG electrodes. The EEG electrodes may be configured to be attached to a patient's scalp, for example, at standard locations on the scalp. The EEG electrodes may be configured to measure electric potentials on the scalp. The measured electric potentials may indicate electrical activity within a section of the brain. Thus, measurements by the EEG electrodes may provide measurements of neural activity in the section of the brain where the EEG electrodes are attached nearby.
[0094] The neural activity sensor may include EMNG electrodes. The EMNG electrodes measure the speed and conductivity of motor and sensory nerves using sterilized needle electrodes or electrodes stimulated with an electric current. The quality of the measured muscle response may convey the severity of damaged tissue and the type of peripheral nerve damage.
[0095] The neural activity sensor may include spinal nerve activity sensors. For example, each spinal nerve activity sensor may be the same as or operate similarly to an MEG sensor. In this case, an array of spinal nerve activity sensors arranged along a patient's spinal column may measure a magnetic field resulting from an electric current generated by neural activity in the spinal cord. Thus, measurements using spinal nerve activity sensors may provide a map of neural activity within the spinal cord. In some cases, the spinal nerve activity sensors may operate in a manner similar to EEG electrodes or in another manner suitable for measuring neural activity in the spinal cord. In some cases, spinal nerve activity sensors, or other types of sensors, may be arranged and configured to measure neural activity near other parts of the nervous system (e.g., near one or more nerves).
[0096] The nerve activity sensor may include other types of sensors for measuring nerve activity in tissues affected by injury, inflammation, or ischemia, or the activity of any other cell type, for the purpose of determining a correct medical diagnosis.
[0097] According to a preferred embodiment of the present invention, the array of sensors 500 includes impedance sensors, temperature sensors, electromagnetic field sensors (such as SQUID sensors and / or Hall effect sensors), and further dielectric constant and magnetic permeability sensors. The ultimate sensitivity of SQUIDs is ideal for biological research. Magnetoencephalography (MEG) infers, for example, regarding nerve activity in the brain using measurements from an array of SQUIDs. MEG achieves good temporal resolution because SQUIDs can operate at a fairly high acquisition rate compared to the highest temporal frequencies (kHz) of interest in the signals emitted by the brain. A novel application of SQUIDs is the magnetic marker monitoring method used to track the path of orally administered drugs. In a clinical environment, SQUIDs are used in magnetocardiography (MFI), a magnetic field imaging method for detecting the magnetic field of the heart for diagnosis and risk stratification in cardiology. A Hall effect sensor (or simply a Hall sensor) is a device for measuring the magnitude of a magnetic field. Its output voltage is directly proportional to the strength of the magnetic field passing through it.
[0098] Generally, the arrangement configuration of the array of sensors 500 and the array of emitters 400 can be set to match the readings of biophysical signals indicating areas of the nervous system or other tissues affected by injury, inflammation, or ischemia. After multiple treatment sessions, if the readings of biophysical signals in areas of the nervous system or other tissues affected by injury, inflammation, or ischemia that are primarily affected by neurodegeneration or inflammation indicate an improvement in clinical outcome, the machine learning software can reposition the sensors 500 and emitters 400 (i.e., a new sensor 500 and emitter 400 positioning map) and simultaneously instruct the setting of a new baseline treatment protocol for other areas of the patient's body that still exhibit the impaired functionality of the damaged nervous system or other tissues / organs affected by injury, inflammation, or ischemia. The new baseline treatment protocol according to the repositioning map can also be continuously updated in real time simultaneously with the reading of biophysical signals from each of the arrays of sensors 500.
[0099] According to a preferred embodiment of the present invention, the electromagnetic field emitted by each of the arrays of emitters 400 may be corrected in real time simultaneously with the reading of biophysical signals from each of the arrays of sensors 500, and each specific emitter 400 is positioned in close proximity to each specific sensor 500, and the emitters 400 and sensors 500 operate as a pair.
[0100] The portable device 100 may include a helmet, cap, or other headgear or placement configuration for placement on or around a patient's head, and the arrays of sensors 500 and emitters 400 may be movable such that a time-varying pulsating electromagnetic field can be applied to regions of the brain affected by neurodegeneration, ischemia, injury, or inflammation. More preferably, the placement configuration of the arrays of sensors 500 and emitters 400 can be set to match the reading of biophysical signals indicative of regions of the brain predominantly affected by neurodegeneration, ischemia, injury, or inflammation, or other tissues. After multiple treatment sessions, if the reading of the biophysical signals of the regions of the brain indicates an improvement in clinical outcome, the placement configuration of the arrays of sensors 500 and emitters 400 can similarly be changed to other regions of the brain affected by neurodegeneration, ischemia, injury, or inflammation, or other tissues.
[0101] After a placement map including the positions of sensors 500 and emitters 400 is created by machine learning software, the electrodes and emitters can be placed on a custom enclosure for the patient's tissue / organs. When the machine learning software calculates the exact coordinates for the optimal positions of the arrays of sensors 500 and emitters 400, in addition, an extender can be created that can be easily attached to the main enclosure providing structural stability and has the ability to accurately mount the sensor 500 or emitter 400. The enclosure may preferably comprise a casing having an adjustable pre-installed array of sensors 500 and emitters 400, which can then be moved to the optimal treatment position along the X, Y, and Z axes.
[0102] Figure 1 is a schematic perspective view of the portable device 100 of the system of the present invention. Generally, this is designed as a portable device 100 with an adjustable strap 101 that can be placed on the patient's back or shoulder to perform treatment throughout the day or the entire wearing time. This consists of a basic pocket 102 that provides a storage area for an array of sensors 500 and an array of emitters 400, and a touch screen display 103 that indicates the type of treatment protocol, remaining time, battery status, general information regarding previous and current treatment sessions (such as the current, voltage, and frequency used, graphical display of the readings of biophysical signals, etc.), and all other important information, and enables the change of the treatment protocol simultaneously with the reading of biophysical signals. The portable unit 100 is also configured to warn the patient regarding improper use or its function. The touch screen display 103 is configured to enable the simultaneous modification of the treatment protocol while taking into account the reading of biophysical signals from the array of sensors 500 via a cloud service and also through the processor and computing unit 104. The touch screen display 103 is configured to show the intensity of the electromagnetic field around neurons or other tissues and its changes during the treatment session. The touch screen display 103 is wirelessly connected to an online main database that can be accessed in real time by the patient's attending physician via the portable part of the portable device 100, monitors the progress of the outcome of the treatment protocol being administered, and can perform an emergency intervention if necessary.
[0103] Within itself, the portable device 100 houses a computing unit 104 for recording all measurements of biophysical signals from the array of sensors 500 and simultaneously delivering a baseline or individualized treatment protocol through each of the array of emitters 400 controlled by the computing unit 104 through a feedback loop control system. Finally, the portable device 100 is provided with a power source such as a rechargeable battery 105 that can be inserted within the portable device 100 for the purpose of maintaining portability. The portable device 100 of the system includes, without limitation, a main control board with a processor, RAM memory, and storage area that controls machine learning software along with the sensor / emitter section, a battery management system with the rechargeable battery 105, and a security section with fuses and FID elements, among several major components housed internally. Since the portable device 100 is provided with a plurality of rechargeable batteries 105, when a patient runs out of one battery 105, instead of charging it and waiting for the charge to complete, the patient can continue the treatment session using another previously fully charged battery 105. The portable device 100 may be composed of various solar panels to function as a power source for recharging the battery.
[0104] The computing unit 104 may include one or more units configured to interface with the array of sensors 500 via the touch screen display 103. For example, the units of the computing unit 104 may be contained within a single case or housing, or may be separate from each other. Separate units of the computing unit 104 may be interconnected by cables or via a wireless connection. In some cases, the units of the computing unit 104 may be remote from each other. When the units of the computing unit 104 are remote from each other, different units of the computing unit 104 may be configured to communicate with each other via a network or other cable or wireless communication channel. In some cases, some or all of the touch screen display 103 may be included in the processor (in which case, the touch screen display 103 may only include the connection of the processor to the array of sensors 500). In some cases, some or all of the functionality of the touch screen display 103 may be provided by a processor operating according to programmed instructions.
[0105] The portable device 100 may be connected to the fixed device 200 through a port arranged and configured on the back of the portable device 100, which is fitted into the connection port 204 of the fixed device 200, as a result of which a calibration and initialization process is carried out or any other connection method that may be considered appropriate depending on the situation. After the initialization process is completed and the baseline or new treatment protocol is checked by the machine learning software and supervised by a medical expert, the patient can take the portable device 100 home and use it comfortably at home instead of using a similar device in a hospital environment that many patients dislike. In this way, the treatment is carried out over a longer period of time and is further tailored to the patient's lifestyle and the severity of the symptoms, often requiring a longer treatment exposure time. The portable device 100 may change its shape, and the components and other parts can be changed according to the desired effect, the patient's needs and the treatment period.
[0106] Figure 2 shows a perspective view of the fixation device 200 of the system of the present invention, the calibration, control, and treatment stations positioned within a normal healthcare facility. The fixation device 200 includes an automatic device calibration station 201 and a processing, control, and treatment station 202 (hereinafter, "processing station 202"). After the portable device 100 is inserted into the connection port 204 of the fixation device 200, the portable device 100 is automatically calibrated, the arrays of the sensors 500 and the emitters 400 are inspected for accuracy, and a baseline treatment protocol can be delivered before being handed to the patient for use. The main advantage of such automatic calibration is to reduce the possibility of human error in the treatment planning process based on previous cases of similar disease management and patient recovery outcomes, and further to apply machine learning algorithms to optimize the baseline treatment protocol and the treatment duration. On the other hand, the processing station 202 is configured to enable the visualization of the measurements collected from the arrays of the sensors 500 available within the portable device 100, the visualization of other diagnostic tests previously performed, the visualization of the patient's medical history, and further to plan future treatment protocols and track the patient's recovery progress through personalized data representation, filtering, and recording. This data can be stored locally in the main database and further on the cloud. This idea is to enable medical professionals to use the workspace in front of the LCD screen to better interpret and understand the patient's recovery progress. When the portable device 100 brought by the patient is inserted into the connection port 204, the calibration sequence is initiated, and further, it may be possible for medical professionals to modify the baseline treatment protocol and inspect the patient recovery outcome during the ongoing treatment. The computing unit 104 of the portable device 100 is configured to transmit the treatment data stored in the HDD or cloud storage to the fixation device storage so that it can be easily accessed by trained medical professionals.Medical professionals should be qualified in an educational course regarding the optimal way to operate both devices 100 and 200, and furthermore, the optimal way to cooperate with machine learning software in the common goal of adjusting the baseline treatment protocol based on the recorded measurements of biophysical signals each time a patient undergoes a control health assessment. The fixed device 200 may be connected to a power outlet with a power cable, and in an ideal setup, it should be connected to an emergency backup generator so that in the event of a power outage, it does not lose potential information regarding the patient's treatment and furthermore does not compromise the integrity of the fixed device 200 while the calibration process is in progress.
[0107] The communication interface of the processing station 202 may interface with one or more components. For example, the communication interface may communicate with an input device to enable operator input to the processing station 202. For example, the operator input may include clinical data, operation commands for controlling the operation of components of the protocol generation system (or the treatment system), or other input data. The communication interface may include a device or port for reading and writing one or more types of portable or removable data storage media. For example, the data storage media may be used to store acquired measurement data or clinical data input to the processing station 202, or treatment protocols input to the treatment system.
[0108] The measured quantity can be stored on the data storage device as acquired measurement data. For example, the acquired measurement data may be in the form of a sequence of an electromagnetic field that is sensed, tissue impedance, permittivity and permeability, temperature, or other measured values acquired at a known time. The processing station 202 can be configured to apply one or more data manipulation techniques to the acquired measurement data. For example, the data manipulation techniques can include applying averaging, digital noise reduction, calibration, scaling, separating a signal from a background signal (e.g., a signal acquired when the patient is at rest or doing nothing), smoothing or sharpening (e.g., applying a low-pass or high-pass digital filter), or applying another analysis technique.
[0109] One or more signal processing or other data analysis techniques may be applied to the acquired measurement data. As a result of the application of the data analysis technique, one or more reference profiles (neural activity profiles and other tissue activity profiles) may be obtained. For example, each neural network activity profile may be based on the measured neural activity associated with a particular neural network (e.g., based on measurements acquired while a patient is performing a task associated with that particular neural network), distinguishing it from the measured neural activity associated with different neural networks (or when the neural network is expected to be inactive, such as when the patient is at rest). The resulting reference profile may be stored as part of the main database on the data storage device. For example, measurement data acquired in the form of a time sequence of measured electromagnetic fields may be processed to obtain a spectrum in the form of amplitude, frequency, intensity, and strength. One or more transforms, such as Fourier transform, wavelet transform, or other transforms, may be applied to the acquired measurement data. The transform may be applied, for example, by utilizing an algorithm such as a fast Fourier transform (FFT), filtered FFT, wavelet analysis, or another spectral filter. Other analysis techniques may also be applied. Such other techniques may include one or more statistical evaluations, such as the application of one or more computational neural networks, machine learning, or deep learning algorithms.
[0110] The analysis may be performed separately for each of the array of sensors 500, for a subset of the array of sensors 500 (e.g., those of the same type in adjacent or functionally linked locations), or for all sensors 500 (e.g., those of a particular type). The analysis may be to identify the difference between an individual patient and the expected performance. The analysis may be to identify whether an individual patient is associated with a more generalized group for which a particular treatment protocol has previously been found to be beneficial.
[0111] When data is obtained for a group of subjects whose nervous system is demonstrably sound (e.g., there are no events in the subject's medical history that could be suspected of impairing the nervous system, there are no observable symptoms of injury to the nervous system in the subject, or it is otherwise determined to be sound), the analytical data obtained can be combined, for example, by averaging, or by applying other statistical or data combination techniques. The combination obtained as a result of each profile can be stored in the main database as a reference profile for neural networks, organs, or other tissues.
[0112] Similar measurements and analyses can be performed on subjects known to have one or more forms of deficiency in the function of the nervous system, organs, or other tissues. For example, the deficient function can be related to the performance of a specific task (e.g., motor, cognitive, sensory, or other tasks), or can be associated with a known anatomical abnormality (such as determined by imaging techniques or other methods). The resulting profile can be compared to the corresponding representative reference profile. This comparison can result in one or more electromagnetic fields characteristic of the neural network, organ, or tissue associated with the deficient function.
[0113] The protocol generation system may measure a neural activity profile for a patient when a nervous system injury to the patient is suspected. Neural activity measurements at one or more locations on the patient's body can be obtained using neural activity sensors such as an array of electroencephalogram (EEG), electromyogram (EMNG), or magnetoencephalogram (MEG) sensors, as well as an array of sensors 500 such as temperature sensors, SQUIDs and / or Hall effect sensors, or other sensors for measuring electromagnetic fields. As a result of the analysis of the measurements, a patient profile can be obtained that can be compared to one or more reference profiles. In particular, when the patient exhibits symptoms associated with a deficient function of a specific neural network, the analysis can be limited to, or prioritized, or emphasized in a comparison with the neural network electromagnetic field associated with that neural network.
[0114] The patient profile can be compared by the processing station 202 with a corresponding reference profile retrievable from the main database. The electromagnetic field of one or more neural networks, organs, or other tissues can be selected for analysis. The neural network, organ, or other tissue electromagnetic field can be selected based on preclinical and clinical data. For example, a patient may exhibit one or more symptoms recorded in the clinical data. For example, symptoms may include the inability or reduced ability to move a limb spontaneously (e.g., when the skeleton and musculoskeletal system are intact), to speak, to receive sensations, to perform cognitive tasks (e.g., to read, to identify a person or object, to solve a problem, or to perform another cognitive task), or to respond to another type of stimulus. Each symptom may also result from impaired function (e.g., related to various memories, planning, motor activation, feedback, organization, or other functionality of the nervous system) of one or more neural networks, organs, or other tissues affected by injury, inflammation, or ischemia. Each selected value of the electromagnetic field can correspond to one of the neural networks. Further analysis then attempts to detect one or more impaired functions of the selected neural network. The same applies to each organ or other tissue respectively.
[0115] In some cases, the comparison between the patient profile and the retrieved corresponding reference profile can detect one or more differences or deviations between the function of the patient's neural networks, organs, or other tissues and the function of those neural networks, organs, or other tissues in a healthy individual. The comparison can identify the electromagnetic field range in which the detected deviation occurs. Such a deviation can indicate an abnormality in the behavior of the corresponding neural network, specific cell group, organ, or other tissue.
[0116] In particular, this comparison can show deviations in the amplitude, frequency, strength, or intensity of the patient profile in one or more electromagnetic fields. The measured patient profile can be spatially mapped onto the brain, nervous system, organs, or other tissues of the patient affected by injury, inflammation, or ischemia.
[0117] Treatment station 202 may be configured to generate a baseline treatment protocol based on the detected differences between the patient profile and the retrieved reference profile. The generated baseline treatment protocol may be stored on the data storage device of the portable device 100. Alternatively, or in addition, for example, if the protocol generation system and the treatment system are incorporated into a single system or are configured to communicate with each other, the portable device 100 may automatically retrieve the baseline treatment protocol to be used to treat the corresponding patient from the data storage device of the treatment system.
[0118] The generated baseline treatment protocol may be applied by the computing device 104 when operating an electromagnetic field generator configured to generate a current flowing through the treatment coils 304 - 310. The operation of the electromagnetic field generator may cause a current to flow through one or more of the conductive treatment coils 304 - 310. The flow of current through the treatment coils 304 - 310 may generate a treatment electromagnetic field applied to the patient. The amplitude of the current flow may determine the amplitude of the treatment electromagnetic field. Applying the treatment electromagnetic field to the patient according to the baseline treatment protocol or the personalized treatment protocol may result in an increase in neural activity or the activity of the surrounding cells within the target tissue. The increase in neural activity, combined with the increase in the activity of the cells within the surrounding tissue, may facilitate the rehabilitation process in the nervous system and the patient's body, and thus may facilitate the recovery of nervous system function and tissue regeneration.
[0119] The array of sensors 500 is used to monitor the patient during the operation of the electromagnetic field generating device. The array of sensors 500 is incorporated within the fixing device 100. In addition to SQUIDs, Hall effect sensors, impedance sensors, and temperature sensors, the array of sensors 500 may comprise one or more sensors configured to measure the movement of the patient's body and further the permittivity and permeability of the tissue. The array of sensors 500 may be configured not to interfere with the magnetic field radiated by the array of emitters 400.
[0120] Computing unit 104 may be configured to modify or update in real time the application of a baseline treatment protocol (e.g., as applied to at least a particular patient) according to one or more quantities monitored by an array of sensors 500. For example, if the value of a monitored quantity obtained by one or more sensors 500 deviates from an expected value, computing unit 104 may be configured to change the amplitude, frequency, type, or duration of a treatment electromagnetic field applied to a patient via one or more emitters 400 each operating in pair with said sensor 500 to obtain the expected value. The expected value is within an electromagnetic field range, or other biological, biophysical, or biochemical signal range, for each organ and cell type defined through preclinical and clinical trials. As another example, if the value of a monitored quantity indicates that the treatment has been completed (e.g., has resulted in a desired or expected effect in the patient), the continuous application of the treatment electromagnetic field may be shortened, reduced, or modified in some other way.
[0121] In some cases, the baseline treatment protocol may indicate the period or duration of the application of the treatment electromagnetic field. This period may relate to the period of a single treatment session (in which case the protocol may indicate one or more of the frequency of repetition of the application of the treatment electromagnetic field, the number of times the treatment electromagnetic field is applied, and the interval between applications of the treatment electromagnetic field). This period may include the entire treatment time (e.g., in situations where different applications of the treatment electromagnetic field are expected to have a cumulative effect). The baseline treatment protocol may include an iterative scheme for repeated application of the treatment (e.g., for a particular patient, or for a class or group of patients).
[0122] FIG. 3A schematically illustrates a perspective view, a side view, and a top view of one emitter 400. Generally, each emitter 400 includes an emitter coil housing 303, electrodes 304-310 disposed and configured within the housing 303, the electrodes 304-310 being configured to emit uniform and non-uniform time-varying or steady electromagnetic fields, an emitter coil housing 303 having a housing cap 302 disposed and configured at the top thereof to enable easier extraction and replacement of the coils for obtaining different electromagnetic field types and their properties, and a current supply line 301 connected to the electrodes 304-310 for supplying power to the electrodes.
[0123] Each of the emitters 400 will be positioned on a specific part of the patient's body where a conductive gel or other conductive substance has been previously applied to maximize the efficiency of treatment delivery. The emitter coil housing 303 is made of a non-magnetic material such as plastic so as not to interact with the electromagnetic fields generated by each of the coils 304-310. The dimensions of the emitter coil housing 303 can vary with respect to the specific region of the patient's body to which the array of emitters 400 is applied. The wires supplying power to the coils 304-310 are insulated to minimize the risk of an accident occurring while the portable device 100 is in use and are directly connected to the sensor / emitter portion of the computing unit 104 inside the portable device 100. Each of the arrays of emitter coils 304-310 does not interfere with an array of sensors 500 for measuring biophysical signals, particularly electromagnetic fields, because each of the arrays of emitters 400 includes a built-in element (so-called screener) that filters out stronger electromagnetic fields radiated by the coils 304-310.
[0124] Each of the emitters 400 is connected to a computing unit 104 that adjusts the power, amplitude, type, and frequency of the electromagnetic field, as well as the duration of the treatment, as defined by the baseline treatment protocol. The baseline treatment protocol is generated by machine learning software and supervised by medical experts. The baseline treatment protocol can be directly modified by the settings of the portable device 100.
[0125] According to various embodiments of the present invention, the emitter coil housing 303 can be modified to include an emitter coil housing 303 that preferably further includes a plurality of coils 304-310 or to include different configurations / arrangement configurations.
[0126] Figure 3B shows a side view of an emitter coil housing 303 including various differently shaped coils 304-310 that can be arranged within the housing 303. Generally, the most basic shapes of coils that can be used to radiate uniform and non-uniform time-varying or steady electromagnetic fields are solenoid / Tesla coils 304, current supply loops 305, current loops 306, Helmholtz coils 307, Maxwell coils 308, solenoid cones 309, variations of current supply loops 310, and combinations thereof, as well as other coil types not previously listed that have different geometric shapes of the aforementioned coils, and are selected from the group including.
[0127] Each of the coils 304-310 described above can be made of spray insulated copper wire or wires of different materials, depending on the type of treatment protocol the patient is receiving. Each of the selected coils 304-310, or combinations thereof, is fixed inside each emitter coil housing 303 to prevent misalignment within the housing 303 while each emitter of the array of emitters 400 is positioned on the patient's body.
[0128] Furthermore, according to an embodiment of the present invention, the above-described coils 304 to 310 are made of different metals such as gold, silver, and aluminum, and these can be changed based on the needs of the patient. For example, since there is an array of emitters 400 disposed on the patient's body, aluminum coils may be used when a lighter set of coils 304 to 310 is required, and gold coils may be used when a smaller number of arrays of stronger emitters 400 are required in order to maximize the efficiency of electromagnetic field application by minimizing resistance.
[0129] There, a general description of the coil shape is shown, but they may be further modified based on the above seven basic types in order to optimize the field strength and delivery treatment protocol based on the type of disease and the duration of each treatment session.
[0130] FIG. 4 illustrates the most common variations of the positioning map of the emitter 400 and the sensor 500 for the patient in a front view, a rear view, and a top view according to the patient's baseline condition and the tissues or organs affected thereby. The baseline (personalized) treatment protocol, i.e., the intensity, frequency, nature, and direction of the personalized electromagnetic field to be delivered over a certain period of time, each of the sensors 500 and any other sensor arrays for measuring the electromagnetic field, impedance, and temperature may be disposed in close proximity to each of the emitters 400, and each of the sensor arrays of the sensors 500 and each of the emitter arrays of the emitters 400, which are disposed in close proximity to each other, operate as a pair. Other sensors may be disposed on the patient's heart and arm and may be used to monitor the patient's biological functions.
[0131] The portable device 100 can be used for the treatment of any medical condition, from neurological to oncological, chronic, viral, etc., such as tissues affected by injury, inflammation, or ischemia. Therefore, the reference positioning map and baseline treatment protocol for the arrays of emitters 400 and sensors 500 are established individually for each disease, and even for each organ or tissue. When the portable device 100 is intended to be used in the magnetic, electrical, or electromagnetic induction of transplanted cells, injected or ingested drugs or agents, the arrangement and shape of the array of emitters 400 greatly depend on the desired location where the treatment or transplanted cells should reach.
[0132] Figure 5 shows another embodiment of the portable device 100, and illustrates an exemplary treatment system for subjecting a patient to electromagnetic field therapy generally for managing diseases affected by viruses or infections. This embodiment of the portable device 100 can be used to inactivate virus replication and reduce the efficiency of virus binding and other antibacterial mechanisms.
[0133] Generally, when the virus is not inside the cell or has just started to infect the cell, the virus consists of three main parts, namely, the genetic material that plays the role of encoding the structural proteins used when the virus acts, the capsid (protein membrane) that protects the genetic material of the virus, and the virus envelope (lipid bilayer). In addition to targeting virus binding sites or inducing antigens to train the immune system, as in currently used vaccines, we also recognize three other potential approaches to fighting the virus based on its structure when the virus has already entered the body, namely, the approach of targeting the genetic material and inactivating virus replication, the approach of damaging the integrity of the capsid to expose the genetic material and inhibiting virus replication, and the approach of destroying the lipid envelope and inactivating virus binding.
[0134] Each of these approaches could also be achieved using electromagnetic fields that can act on both the gene level and the lipid level. For that purpose, the portable device 100 may be configured to perform an electromagnetic field-based anti-pathogenic therapy for whole-body treatment of a patient at specific frequencies and intensities that are harmless to host cells. When attention is paid to virus suppression in vivo, the therapy has two actions: targeting viral genetic material and targeting the viral envelope. Targeting viral genetic material involves delivering an electromagnetic field frequency that varies heterogeneously or homogeneously over time, the frequency matching the resonance frequency of the genetic material, affecting its integrity and invalidating proper virus replication - slowing down the progression of the virus and weakening its effect.
[0135] When looking at the phospholipid bilayer that makes up the lipid envelope of many viruses, as in the case of the novel SARS-CoV-2, this is a thin polar membrane consisting of a bilayer of lipid molecules. The polarity of this lipid membrane is highly electrically manipulable by its inherent electric dipole moment, causing charge separation at the positively and negatively charged ends.
[0136] One of the most interesting properties of such a polarized lipid bilayer is flexoelectricity. This is a property of a dielectric material that exhibits a spontaneous electric polarization induced by a strain gradient. This means that once mechanical stress is applied to the virus, the virus shows electric polarization. Since viruses have different structures and functions, they should also exhibit an external surface charge that is very different from the innate cells of the immune system, and the virus can be easily targeted using the frequency and intensity of the field inherent to the charge for the purpose of changing its structural integrity.
[0137] The portable device 100 can affect the conductivity, permittivity, permeability, and polarity of the viral envelope. Moreover, due to the presence of charged components on the lipid envelope, the portable device 100 changes the spontaneous polarization of the membrane. The currently recognized main mechanism by which SARS-CoV-2 infects cells is the cleavage of the spike protein on the virus surface by a protein called TMPRSS2. This causes the release of viral RNA into the cell, causing the cell to produce copies of the virus and the virus to spread and infect more cells. The portable device 100 can be used to functionally destabilize the spike protein on the virus surface by changing the surface charge. In this way, we can significantly reduce the efficiency with which the virus enters human cells.
[0138] Figure 6 illustrates another embodiment of the portable device 100 used for vaccine production. The application of electromagnetic field-based devices can speed up vaccine production. Briefly, a vaccine is a suspension of microorganisms that induces antibody production to protect against disease. This greatly depends on the body's own immune system generating an appropriate immune response against the pathogen-delivered antigen, enabling the body to produce antibodies that will fight the pathogen after the host is infected following vaccine inoculation. Vaccines can be divided into two main types, namely whole-agent vaccines and subunit vaccines. Whole-agent vaccines can be either inactivated (killed) or attenuated (weakened) microorganisms. In contrast to inactivated vaccines, which usually use formalin to kill the microorganisms, in attenuated vaccines, DNA / RNA mutations accumulate during long-term cell culture growth, weakening the microorganism. On the other hand, subunit vaccines use parts of the microorganism or products and adjuvants (detergents or killed non-pathogenic bacteria) to enhance the effectiveness of the vaccine. This vaccine contains antigens (or epitopes) that best stimulate the immune system, such as those caused by hepatitis B, whooping cough, or pneumonia caused by pneumococcal vaccines. In addition to these two main groups, conjugate vaccines also exist, which are special subunit vaccines where the antigen is bound to a polysaccharide, which also makes them extremely complex to produce. These vaccines are most effective for the immature systems of infants and include pneumonia caused by H. influenza type B and pneumococcus. There are also numerous experimental types of vaccines, two of which are DNA / RNA and recombinant vector vaccines. DNA / RNA vaccines contain the DNA / RNA of important antigens introduced into cells, which are being developed for influenza, herpes, and HIV, while recombinant vector vaccines consist of attenuated viruses or bacteria (vectors) used to introduce the DNA / RNA of the microorganism into cells. Recombinant vector vaccines are also being tested against HIV, rabies, and measles.The most common pneumonia or influenza vaccines currently in use are classified into either subunit vaccines or conjugate vaccines. One of the major drawbacks of subunit, conjugate, and DNA / RNA vaccine production is the time required to identify specific antigens, which is particularly occurring in SARS-CoV-2 vaccine development today. The development speed is slowed down by the difficult and long process of identifying specific antigens.
[0139] To facilitate better antigen activation and increase the speed of vaccine production, another embodiment of the electromagnetic system can be used to advance vaccine production at all stages, namely, antigen generation, antigen release and isolation, and purification. Before a vaccine is produced, antigens that trigger the body's immune response need to be generated. This is done by collecting and growing the pathogen's proteins or DNA / RNA, which can be achieved by growing the virus in primary cells such as cells derived from chicken embryos, growing bacteria in bioreactors to optimize antigen production, and inducing recombinant proteins from pathogens in yeast, bacteria, or cell cultures. By performing antigen production with the electromagnetic system of the present invention, the transmission between immune cells is significantly accelerated through signal transduction pathway alteration or amplification, thereby advancing the screening process.
[0140] To release many of the pathogens, the antigens are then separated from the cells and isolated from the protein or any other part of the growth medium that is still present. The electromagnetic system of the present invention speeds up and makes antigen separation more accurate by generating specific field gradients.
[0141] To purify the antigen, several separation steps are performed, taking advantage of differences in protein size, physicochemical properties, binding affinity, or biological activity. The electromagnetic system of the present invention is efficient in electromagnetic purification, and to that end, it takes advantage of the electromagnetic and electromechanical differences of proteins to speed up and make the purification process more efficient.
[0142] FIG. 7 illustrates another embodiment of a portable device 100 that exemplifies an exemplary treatment system that subjects a patient to electromagnetic field therapy to stimulate the immune system to make the response to the vaccine more rapid and robust. An adjuvant is added to enhance the patient's immune response to the supplied antigen. After adding a stabilizer or preservative, all the components are then combined and uniformly mixed in a single vial. This step makes the development of the combined vaccine more difficult because of potential incompatibilities and interactions between the antigen and the other components. After the adjuvant is added, potential incompatibilities and unwanted interactions can occur between the antigen and the other components of the vaccine, so using electromagnetic field therapy at the vaccine administration site locally stimulates the immune system and makes the response to the vaccine more rapid and robust.
[0143] FIG. 8 is another embodiment of the system of the present invention in a hospital environment. Not only for the novel SARS-CoV-2 virus, but also for other viruses predicted to emerge in the next few years, the need to accelerate and improve drug production and vaccination has suddenly been globally recognized. The system of the present invention can be modified with respect to a plurality of electrodes 400 that emit electromagnetic fields throughout the body to strengthen the immune system in order to respond to new viruses or as adjuvant therapy for patients undergoing chemotherapy, radiotherapy, or with a compromised immune system. Therefore, the present system can be implemented in several different ways for the purpose of treating acquired or congenital diseases of the living body or for the protection of healthy individuals. Although the main embodiments of the system are presented, this may be implemented in the form of a plurality of electrodes 400 on the wall that emit electromagnetic fields for the purpose of immediately but temporarily enhancing human immunity. Its main advantage is to provide systemic therapy and improve the overall function of the immune system, and it should be used for people at immediate risk of infection by viruses or bacteria (e.g., medical professionals, the elderly, immunocompromised individuals).
[0144] Regarding the flowcharts referred to herein, it should be understood that the division of the illustrated method into individual operations represented by the blocks of the flowchart is selected only for convenience and clarity. Alternative divisions that divide the illustrated method into discrete operations are possible with equivalent results. Such alternative divisions that divide the illustrated method into discrete operations should be understood to represent other embodiments of the illustrated method.
[0145] Similarly, unless otherwise stated, it should be understood that the illustrated order of execution of the operations represented by the blocks of any flowchart referred to herein is selected only for convenience and clarity. The operations of the illustrated method can be executed in an alternative order or simultaneously, and equivalent results can be obtained. Such rearrangements of the operations of the illustrated method should be understood to represent other embodiments of the illustrated method.
[0146] FIG. 9 illustrates a flowchart of a method for generating an electromagnetic therapy protocol for treating a nervous system, other tissue, or organ affected by injury, disease / disorder, inflammation, or ischemia in a patient. According to one embodiment of the present invention, a method for generating an electromagnetic therapy protocol for treating a nervous system or other tissue or organ affected by injury, inflammation, disease / disorder, or ischemia in a patient includes creating a patient personal folder and associating the patient personal folder with the serial number of the portable device 100 (block 601), importing the patient's medical history (i.e., patient data) from an electronic patient record into the patient personal folder and determining which disease or condition the description of the patient's symptoms and signs pertains to (block 602), importing predefined electromagnetic field strengths and frequencies to be used to obtain an optimal therapeutic effect for each organ or tissue, depending on the general or target cell type (block 603), comparing the patient data by machine learning software with similar or same condition cases in the main database and importing one or more baseline treatment protocols and a positioning map of one or more reference sensors 500 and emitters 400 (block 604), if a similar baseline treatment protocol is found (block 605), the machine learning software compares the patient data with that from the similar protocol and extrapolates the baseline treatment protocol and the positioning map of one or more reference sensors 500 and emitters 400 (block 606), having a medical expert review the baseline treatment protocol and the reference positioning map (EMF strength, treatment duration, waveform, frequency, etc.) and confirm the baseline treatment protocol or modify it to a new protocol suitable for the patient (block 608), and saving the baseline / new treatment protocol and one reference or new positioning map in the patient's personal folder in the main database, saving it on the portable device 100, calibrating the portable device 100 by the fixed device 200 to inspect the array of sensors 500 and emitters 400 for accuracy, and saving the baseline or new treatment protocol in the storage area of the portable device 100 before patient use (block 609).If no similar baseline treatment protocol is found (block 605), data is input from the patient's electronic record and one or more positioning maps are imported into machine learning-assisted mapping simulation software to obtain information regarding the sensor 500 and emitter 400 positioning maps (block 607), and a new treatment protocol as well as new sensor 500 and emitter 400 positioning maps are proposed and the parameters of the new treatment protocol are input into the machine learning software (block 610), and the new treatment protocol as well as the new sensor 500 and emitter 400 positioning maps are simulated to establish a confidence interval (block 611). If the simulation does not have a high confidence interval, the steps of block 606 are repeated until a high confidence interval is achieved, and then the baseline / new treatment protocol and the new positioning map are saved on the patient's personal folder, the main database, and the portable device 100, the portable device 100 is calibrated by the fixed device 200 to inspect the array of the sensor 500 and emitter 400 for accuracy, and the baseline or new treatment protocol is saved in the storage area of the portable device 100 before patient use (block 609).
[0147] FIG. 10 is a flowchart showing a method for generating an electromagnetic therapy protocol considering biophysical signals for treating the nervous system, other tissues, or organs affected by injury, inflammation, or ischemia and calibrating it to the patient's needs. When a patient's personal folder is created and the medical history is imported from the electronic patient record (blocks 601, 602, 701), while at the healthcare facility, the baseline therapy protocol is further optimized by taking additional readings of biophysical parameters, whereby the machine learning software may propose a reference sensor 500 and emitter 400 positioning map on the patient's body. To obtain a more appropriate baseline therapy protocol for the patient's disease or condition, the method for generating the baseline therapy protocol further includes obtaining MEG, EEG, EMNG, tissue impedance, temperature, skin conductivity, and further other biological, physical, or chemical parameters using built-in sensors (block 702) or other diagnostic tools. After importing all the obtained parameters into the patient's electronic record, following the positioning of the array of sensors 500 and the sensing of the initial biophysical signals (block 704), the machine learning software updates the patient's personal folder with the sensed initial biophysical signals (block 705), and subsequently, executes the machine learning software to retrieve one or more baseline therapy protocols from the main database and associate them with one or more sensor 500 and emitter 400 placement maps associated with the patient's disease or condition (blocks 604, 703). After obtaining one or more sensor 500 and emitter 400 placement maps associated with the patient's disease or condition, the positioning of the array of sensors 500 and the sensing of the initial biophysical signals continue, the signals including measurements of one or more types of neural activity, temperature, tissue impedance, and electromagnetic fields (block 704). Thereafter, the machine learning software updates the patient personal folder with the read biophysical signals (block 705) and evaluates whether one or more baseline therapy protocols are suitable for the patient considering the biophysical signals (block 706).If one of the baseline treatment protocols is suitable for the patient considering the biophysical signals, the machine learning software stores the baseline treatment protocol and the reference positioning map in the patient's personal folder within the main database and stores them in the portable device 100 (block, 609 707). If one of the baseline treatment protocols is not suitable for the patient considering the biophysical signals, the method further includes setting and repositioning the array of sensors 500 and sensing the biophysical signals (block 708) as well as providing the feedback biophysical signals to the machine learning software (block 705) in order to evaluate whether one or more of the baseline treatment protocols are suitable for the patient considering the biophysical signal feedback. If one of the baseline treatment protocols is suitable for the patient considering the biophysical signal feedback, the machine learning software stores the new treatment protocol and the new positioning map in the patient's personal folder within the main database and stores them in the portable device 100 (blocks, 609 and 707). The repositioning of the array of sensors 500 and the sensing of the feedback biophysical signals are repeated until the treatment protocol achieves the intended effect. The new, personalized treatment protocol and the associated repositioning of the array of sensors 500 can be stored in the main database as a baseline treatment protocol and a reference positioning map for use with other patients having similar diseases and medical conditions, personalized for each patient.
[0148] To prepare the portable device 100 for determining the use of an optimal baseline treatment protocol or a new treatment protocol, the portable device 100 is connected to the fixed device 200 via the connection port 204, and a patient personal folder is created. While the portable device 100 is being calibrated, the medical expert asks the patient for detailed information regarding the medical history, copies patient data from the online database, and further enables manual input. Patient data is medical information held regarding an individual patient. Patient data may include information related to the patient's past and current health status or illness, treatment history, lifestyle choices, and genetic data. This may also include biometric data, which is any measurable physical characteristic that can be checked by a machine / computer. In parallel, the machine learning software calculates the patient's baseline treatment protocol based on the patient's medical data by retrieving it from the main database of treatment protocols, including therapy regime protocols previously built in pre-clinical and clinical trials. This step determines the treatment duration, intensity, and nature of the electromagnetic field that needs to be applied, and further proposes the potential coil shape to be used. Next, the machine learning software continues to compare the recorded patient data with other patient cases in order to optimize one or more of the baseline treatment protocols associated with the patient's illness. The expert takes into account the patient, their medical records, and information obtained from MEG, EEG, EMNG, tissue impedance, temperature, and skin conductivity, as well as any other biological, physical, or chemical parameters using the built-in sensors, and combines it with one or more of the baseline treatment protocols proposed by the machine learning software regarding the treatment into a new (personalized) treatment protocol. After being combined, the new treatment protocol is saved in the individual patient folders of the patient's portable device 100 and the fixed device 200, which enables the medical expert to confirm (and potentially adjust) the ideal use of the portable device 100 while ensuring maximum efficiency during treatment.
[0149] By considering additional information regarding the patient's lifestyle choices (such as whether the patient smokes, drinks too much alcohol, does not exercise enough, etc.), the machine learning software can also perform calculations (based on simulations) regarding which organs are most diseased and what problems may arise for the patient in the near future. This embodiment will be used when predicting the treatment of EMF therapy.
[0150] FIG. 12 is a flowchart showing a method for generating a placement map of one or more reference sensors 500 and emitters 400 according to an embodiment of the present invention.
[0151] A method for generating one or more reference sensor 500 and emitter 400 placement maps includes steps of compiling diagnostic readings (EEG, MEG, MRI, PET, RTG, EKG, EMNG, etc.) from various medical records for different diseases within major disease groups, having medical experts examine the most common organ regions affected by the major diseases and designing one or more reference sensor 500 and emitter 400 placement maps for each major disease (block 902), designing one or more reference sensor 500 and emitter 400 placement maps for each organ (heart, brain, lungs, etc.) (block 903), inputting the reference placement maps into machine learning software and performing a simulation to check whether the emitter 400 placement targets the organ regions most commonly affected, and cross-referencing it with the diagnostic readings 901 (block 904), placing the sensor 500 within the site / region with the least magnetic flux considering the electromagnetic field lines (block 905), re-performing the simulation using the new sensor 500 and emitter 400 placement maps with machine learning support software (block 906), where the simulation is performed within a specific pre-defined reference electromagnetic field range so as to bring about an optimal treatment effect for each organ or tissue according to the general or target cell types defined throughout pre-clinical and clinical trials, and saving the new baseline placement maps to the portable device 100, the cloud, and the fixed device 200 (block 907). The simulation is performed within a specific pre-defined electromagnetic field range so as to bring about an optimal treatment effect for each organ or tissue according to the general or target cell types defined throughout pre-clinical and clinical trials.
[0152] The major diseases and disorders include, but are not limited to, infectious diseases, deficiency diseases, genetic diseases (including both genetic and non-genetic diseases), and physiological diseases, which can be further divided into neurological diseases, heart diseases, lung diseases, gastrointestinal diseases, etc. based on the anatomical regions affected by these diseases / disorders.
[0153] After the personalized sensor 500 and emitter 400 placement map are designed, the next step is for the array of sensors 500 to be placed on the patient's body according to machine learning software or a previously designed general scheme / map obtained during pre-clinical or clinical trials of the portable device 100. The array of sensors 500 may use built-in sensors to obtain initial readings regarding tissue impedance, temperature, and skin conductivity, as well as any other biological, physical, or chemical parameters. Using that information, the machine learning software updates the patient profile and checks whether the proposed therapy is suitable for the patient considering the measured body parameters.
[0154] If the baseline treatment protocol is suitable, the portable device 100 is properly calibrated and the patient may carry it to use at home and in daily life according to instructions from a medical professional. On the other hand, if the machine learning software suggests that the proposed therapy is inappropriate, the portable device 100 re-positions the array of sensors 500 to update the treatment protocol, performs another round of measurement of biophysical signals, and is corrected by running the machine learning software. Then, if the treatment protocol is suitable, the patient can start the personalized treatment protocol.
[0155] FIG. 11 is a flowchart showing a method for treating diseases and disorders of the nervous system, other tissues, or any organ affected by an individual's injury, inflammation, or ischemia according to an embodiment of the present invention.
[0156] A method for treating diseases and disorders of the nervous system, other tissues, or any organ in an individual affected by injury, inflammation, or ischemia is to obtain biophysical signals from an array of sensors 500 (block 801), update a baseline treatment protocol 707 according to the read biophysical signals to personalize for the patient, and apply the updated personalized treatment protocol in real time through an emitter 400 (block 803), and simultaneously obtain biophysical signals from the array of sensors 500 (block 804), where each specific emitter 400 is positioned in close proximity to each specific sensor 500, and the emitter 400 and the sensor 500 operate as a pair, including, but not limited to, comparing the biophysical signals of each sensor 500, including a reference electromagnetic field range, with signals in a database of healthy individuals and a database containing reference electromagnetic field intensities and frequencies for each organ or tissue (block 805), and when similar biophysical signals are obtained for all or some of the array of sensors 500, stopping the treatment protocol for all or some of the array of sensors 500 (block 807), and evaluating disease progression and treatment outcome (block 808). On the other hand, when similar biophysical signals are not obtained for all or some of the array of sensors 500 (block 806), the extraction of biophysical signals from the array of sensors 500 is repeated, and steps 802 to 806 are repeated until all of the array of sensors 500 read an electromagnetic field within the reference electromagnetic field range, or until the specified duration of exposure to the treatment electromagnetic field defined by the baseline treatment protocol, i.e., the treatment session, regardless of the obtained biophysical signals. Similar biophysical signals can be MEG, EEG, MRI, PET, RTG, EKG, EMNG, etc., or similar medical histories / diagnoses or similar symptoms.
[0157] The present invention provides a protocol generation and treatment system for use in treating physical diseases, mental diseases, infectious diseases, non-infectious diseases, deficiency diseases, genetic diseases, degenerative diseases, etc.
[0158] A protocol generation and treatment system as described herein can be used for the treatment of diseases and disorders of the nervous system, cognitive impairments such as epilepsy, bipolar disorder, schizophrenia, dementia, heart disease, immunodeficiency or autoimmune diseases, tumors, cancer and other oncology diseases, viral or bacterial infections, inflammatory diseases, diseases and disorders of muscle tissue, and diseases and disorders of connective tissue.
[0159] Neurological diseases are diseases of the central and peripheral nervous systems. In other words, this is the brain, spinal cord, cranial nerves, peripheral nerves, nerve roots, autonomic nervous system, neuromuscular junction, and muscles.
[0160] The protocol generation and treatment system described herein can be used in the treatment of neurological diseases and disorders, including but not limited to epilepsy, Alzheimer's disease and other dementias, cerebrovascular diseases including stroke, migraine and other headache disorders, multiple sclerosis, Parkinson's disease, Huntington's disease, ALS, neurological infections, brain tumors (such as glioblastoma, astrocytoma, ependymoma, etc.), traumatic diseases of the nervous system resulting from head trauma, and neurological diseases and disorders resulting from nutritional deficiencies. Furthermore, these also include cerebral aneurysms, subdural / epidural hematomas, cerebral edema, stroke, physical brain injury, hydrocephalus, epilepsy, and other nerve diseases and neurological disorders.
[0161] The protocol generation and treatment systems described herein are applicable to, but not limited to, vasculitis, lupus, cancer, muscle spasm, heart attack, sports injury, muscular dystrophy, cerebral palsy, dermatomyositis, compartment syndrome, myasthenia gravis, mitochondrial myopathy, rhabdomyolysis, polymyositis, fibromyalgia, myotonia, myofascial pain syndrome, muscle spasm, contusion and bruise, tendinitis, depression, urinary and fecal incontinence, hypertension, back pain, lower limb immobility syndrome, Guillain - Barré syndrome, quadriplegia, paraplegia, diabetic polyneuropathy, movement disorder, paresthesia, dental treatment pain, osteoarthritis of the knee, anesthesia, angina pectoris, ankylosing spondylitis, burn pain, cancer pain, chronic pain, dysmenorrhea, headache, hemiplegia, hemiparesis, labor pain, facial pain, trigeminal neuralgia, toothache, fascial pain, nausea during pregnancy, neck or shoulder pain, fracture pain, rib fracture, diabetic peripheral neuropathy, phantom limb pain, post - herpetic neuralgia, postoperative ileus, irritable bowel syndrome, postoperative nausea or vomiting, postoperative pain, post - stroke rehabilitation, rheumatoid arthritis, skin ulcer, spinal cord injury, temporomandibular joint pain, detrusor muscle instability, spinal muscular atrophy (pediatric), pain during hysteroscopy, gastric paresis, chronic obstructive pulmonary disease rehabilitation, carpal tunnel syndrome, soft tissue injury, intermittent claudication, attention - deficit / hyperactivity disorder (ADHD), cognitive impairment, artificial knee joint replacement injury, achalasia, atrophic eczema, bursitis, dementia, depression, oral dryness dystonia, promoting cerebral blood flow, promoting uterine and placental blood perfusion, esophageal spasm, fibromyalgia, fracture pain, Guillain - Barré syndrome, hemophilia, herpes, hip joint pain, interstitial cystitis, irritable bowel syndrome, psychogenic pruritus, labor induction, dysmenorrhea, muscle spasm, muscle rigidity, muscle contusion or pain, musculoskeletal trauma, myofascial pain dysfunction syndrome, nerve injury, osteoarthritis, analgesic adjuvant, pancreatitis, Raynaud's phenomenon, repetitive motion injury, sacral pain, herpes zoster, shoulder joint subluxation, sickle cell anemia pain, skin flap ischemia (reconstructive surgery), Oddi sphincter disease, sports injury, venous thrombosis, tinnitus, tremor, tic disorder, neuralgia, sleep deprivation, anxiety, hallucination, migraine, post - traumatic stress disorder (PTSD), phobic disorder, borderline personality disorder, eating disorder, fatigue, impulse control disorder, irritability, mood disorder, movement disorder, Tourette syndrome, trichotillomania, violent / self - destructive behavior, allodynia, shortening the recovery period of nerve fiber injury or trauma, tumor, ischemic heart disease or coronary artery disease, lower respiratory tract infectionIt can be used in the treatment of diseases and disorders selected from the group consisting of chronic obstructive pulmonary disease and the like.
[0162] (Example) (Example 1) This exemplary experiment was designed to evaluate the EMF effect on the activity of microglia, astrocytes, and oligodendrocytes, and was conducted on mixed glial cells isolated from C57BL6 albino mice. The results are shown in a figure illustrating the average intensity of glial fibrillary acidic protein under the experimental conditions (see Figure 13). The cells were plated at 100,000 cells / 15.6 mm well in a 24-well plate in Dulbecco's Modified Eagle Medium / Nutrient Mixture F-12 (DMEM / F-12) containing 10% heat-inactivated fetal bovine serum (FBS) and 1% penicillin-streptomycin (Pen Strep) and allowed to stabilize for 5 days. Then, the medium was replaced with 1% Pen Strep and DMEM / F-12, and the cells were stabilized at 37°C. Next, the EMF device was placed in the incubator, and the cells were treated with a non-thermal EMF signal consisting of oscillating carrier pulses of 1 - 6 A configured according to the teachings of this application for 3 hours. This procedure was repeated for two additional EMF intensities corresponding to oscillating current intensities of 6 - 11 A and 11 - 15 A, which involved changing the coil shape used and even the nature of the field. Cultures assigned to the control group were always stored in a separate incubator and exposed to the same conditions without an EMF signal. Subsequently, the cells were fixed, immunocytochemically labeled with clusters of glial fibrillary acidic protein (GFAP) and cluster of differentiation molecule 11b (CD11b), and photographed for subsequent analysis. The cell nuclei were labeled with 4',6-diamidino-2-phenylindole (DAPI). The data were analyzed by ANOVA, and graphs of the intensity of each label expressed as a percentage of the total image intensity (100%) were displayed. P-values were used to quantify the probability that the observed differences occurred by chance alone. P ≤ 0.05 is statistically significant (*), P ≤ 0.01 is highly statistically significant (***), P ≤ 0.001 is extremely statistically significant (***), P ≤ 0.0001 is extremely statistically significant (****), and ns was considered not statistically significant. The results in Figure 13 show that EMF application significantly enhanced cell activity, and statistical significance can be seen between the control group and field intensities B2 (P ≤ 0.01) and B3 (P ≤ 0.05).Additional statistical significant differences can be seen among the three treatment groups, where P ≤ 0.05 for B1 - B2 and B1 - B3, and P ≤ 0.0001 for B2 - B3. These results indicate that the EMF signals configured according to the present invention can regulate astrocyte, microglia, and oligodendrocyte activities, and then can regulate cognitive processes, immune responses, and further tissue repair and regeneration.
[0163] As the most abundant cells in the nervous system, astrocytes, together with microglia, play important roles in the neuroimmune system. While microglia function as the first line of defense against foreign pathogens, astrocytes are involved in the repair and regeneration of injured tissues. Microglia also regulate the innate immune function of astrocytes to determine their neuroprotective or neurotoxic functions. Next, astrocytes secrete molecules that trigger microglia activation and regulate the phenotype and function of microglia by affecting their motility and phagocytosis. Astrocytes have hitherto been regarded as merely nerve cell support cells that assist in the regulation of CNS homeostasis, but various studies have shown the role of astrocytes in the phenotype and function of microglia and in the regulation of the innate immune response within the CNS, suggesting that the astrocyte response may further regulate the microglia response.
[0164] Astrocytes play an essential role in the physiological state and immune response within the CNS. They also release neurotrophic factors such as transforming growth factor β (TGF-β) and nerve growth factor (NGF) and play a role in the formation of glial scars. Even though glial scars were previously thought to impede axonal regeneration, recent studies have shown that resection of chronic astrocytic scars invalidates the natural regeneration of transected axons within spinal cord injury (SCI) lesions and increases axonal degenerative retraction. Therefore, contrary to the generally accepted dogma, the formation of astrocytic scars is extremely important for axonal regrowth and is a crucial step in nerve recovery.
[0165] The interpretation of these results suggests that this treatment can be used for the following purposes, as different treatment modalities affect astrocyte activity in different ways when compared to the control group. I. Enhancing astrocyte activity This may cause further microglial activation and the formation of astrocytic scars, which may lead to nerve regeneration and nerve recovery, or II. Reducing astrocyte activity This is particularly useful in diseases where the innate immune system response within the CNS is overly active, such as MS. By using this treatment modality, astrocyte activity can be suppressed, which may lead to the prevention of further demyelination, degeneration, or autoimmune reactions.
[0166] (Example 2) This exemplary experiment designed to evaluate the EMF effect on the activity of nerve cells and NSC cells was conducted on cells isolated from C57BL6 albino mice, and the results are shown in a figure illustrating the average intensity of β-tubulin under experimental conditions (see Figure 14) and a figure illustrating the average intensity of nestin under experimental conditions (see Figure 15). The cells were plated at 50,000 cells / 15.6 mm well in a 24-well plate in Dulbecco's Modified Eagle Medium / Nutrient Mixture F-12 (DMEM / F-12) containing 10% heat-inactivated fetal bovine serum (FBS) and 1% penicillin-streptomycin (Pen Strep) and stabilized over 5 days. Then, the medium was replaced with 1% Pen Strep and DMEM / F-12, and the cells were stabilized at 37°C. Next, the EMF device was placed in the incubator, and the cells were treated with a non-thermal EMF signal consisting of oscillating carrier pulses of 1 - 6 A configured according to the teachings of the present application for 3 hours. This method was repeated for two additional EMF intensities corresponding to oscillating current intensities of 6 - 11 A and 11 - 15 A, which involved using different coil shapes and varying the nature of the field and its frequency. Cultures assigned to the control group were always stored in a separate incubator and exposed to the same conditions without an EMF signal. Then, the cells were fixed, immunocytochemically labeled with β-tubulin (neurons) and nestin (NSCs), and photographed for subsequent analysis. The cell nuclei were labeled with 4',6-diamidino-2-phenylindole (DAPI). The data were analyzed by ANOVA, and graphs of the intensity of each label represented as a percentage of the total image intensity (100%) were displayed. To quantify the probability that the observed differences occurred by chance alone, P-values were used, where P ≤ 0.05 is statistically significant (*), P ≤ 0.01 is highly statistically significant (***), P ≤ 0.001 is extremely statistically significant (***), P ≤ 0.0001 is extremely statistically significant (****), and ns was considered not statistically significant. The results in Figure 14 show that EMF application significantly enhanced neuron activity, and statistical significance can be seen between the control group and field intensities B1 (P ≤ 0.0001) and field intensity B2 (P ≤ 0.05).Additional statistical significance can be seen among the three treatment groups, with P ≤ 0.0001 for B1 - B2 and B1 - B3. The results in Figure 15 show that EMF application significantly enhances NSC activity, and statistical significance can be seen between the control group and field strength B2 (P ≤ 0.0001). Additional statistical significance can be seen among the treatment groups themselves, with P ≤ 0.01 for B1 - B2 and B1 - B3. These results indicate that the EMF signal configured according to the present invention can regulate NSC and neuron activity, and then can regulate cognitive processes, and further nerve repair and regeneration.
[0167] Neurons or nerve cells are electrically excitable cells that communicate with other cells via special connections called synapses. On the other hand, neural stem cells (NSCs) are self-renewing pluripotent cells that first give rise to radial glial progenitor cells that generate all neurons and glia of the nervous system in all animals during the process of embryonic development. Some neural progenitor stem cells remain in very limited regions in the mature vertebrate brain and continue to produce neurons throughout life.
[0168] With that in mind, interpreting the preliminary results suggests that this treatment can be used for the following, as different treatment modalities affect NSC and neuron activity in different ways when compared to the control group. I. Increase NSC / neuron activity This can cause an increase in nerve cell activity, strengthen existing connections, and potentially enable the formation of new connections in diseases where they are damaged or lacking. II. Decrease NSC / neuron activity On the other hand, certain treatment modalities have shown a decrease in NSC / neuron activity, suggesting potential use in suppressing overly active neuron connections in diseases accompanied by excessive neuron firing.
[0169] NSCs, neurons, microglia, oligodendrocytes, and astrocytes can be considered the main building blocks of both the central nervous system (CNS) and peripheral nervous system (PNS) nervous systems and tissues. Thus, we can claim that our treatment modality, which can be modified with respect to field strength, intensity, and nature for each patient, actually affects neural tissue and results in disease treatment.
[0170] In addition, since microglia are derived from the embryonic mesoderm that gives rise to blood and immune system cells, an additional claim can be made that a similar treatment protocol corresponding to the system of the present invention can also be applied to other systems of the body, including the immune system, for the purpose of treating diseases and disorders. According to the former analogy, since neurites naturally interweave with muscle cells, resulting in abundant innervation of muscle cells, the system of the present invention can also be used for the treatment of muscle diseases and disorders, as well as other tissues including electrically excitable cells.
[0171] Different embodiments are disclosed herein. The features of some embodiments may be combined with the features of other embodiments, and thus some embodiments may be combinations of the features of multiple embodiments. The foregoing description of the embodiments of the present invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Those skilled in the art will understand that many modifications, variations, substitutions, alterations, and equivalent forms are possible in light of the above teachings. Therefore, it is to be understood that the appended claims are intended to cover all modifications and / or alterations that fall within the true spirit of the invention.
[0172] Although some features of the present invention have been illustrated and described in this specification, many modifications, substitutions, variations, and equivalent forms will occur to those skilled in the art. Therefore, it is to be understood that the appended claims are intended to cover all modifications and / or variations that fall within the true spirit of the present invention.
Explanation of Reference Numerals
[0173] 100 Portable device 101 Adjustable strap 102 Basic pocket 103 Touch screen display 104 Computing unit 105 Rechargeable battery 200 Fixed device 202 Processing station 204 Connection port 301 Current supply line 302 Housing cap 303 Emitter coil housing 304, 305, 306, 307, 308, 309, 310 Treatment coil 304 Solenoid / Tesla coil 305 Current supply loop 306 Current loop 307 Helmholtz coil 308 Maxwell coil 309 Solenoid cone 310 Variation of current supply loop 400 Emitter 401 Patient's scalp 405 Spinal cord 500 Sensor
Claims
1. 1. A protocol generation and treatment system comprising: - a main database configured to store at least one patient individual folder containing medical patient data, a plurality of baseline treatment protocols, each baseline treatment protocol being associated with a specific disease or indicated impaired functionality of a nervous system, organ or other tissue affected by injury, inflammation or ischemia, one or more associated reference sensor (500) and emitter (400) positioning maps, and representative nervous tissue, organ and other tissue activity profiles associated with reference electromagnetic field ranges for each nervous tissue, organ and cell type of a healthy individual; - machine learning software and a processor configured to compare the medical patient data associated with the specific disease or the indicated impaired functionality, extrapolate one or more baseline treatment protocols associated with the specific disease or the indicated impaired functionality, provide one or more reference sensor (500) and emitter (400) positioning maps associated with the baseline treatment protocols, and determine which of the positioning maps and baseline treatment protocols are suitable for the patient; - a portable device (100) comprising: an electromagnetic field generator configured to generate an electromagnetic field; a storage area configured to store said baseline treatment protocol and a reference sensor (500) and emitter (400) positioning map; an array of sensors (500) configured to measure biological, biophysical and biochemical signals; an array of emitters (400) configured to apply an electromagnetic field; a computing unit (104) configured to record in real time measured biophysical signals from each of said array of sensors (500) and to control said electromagnetic field generator to apply a plurality of different electromagnetic fields through said array of emitters (400) in order to compare the measured biophysical signals with said reference electromagnetic field ranges; and a power source for the components of said portable device (100); - a stationary device (200) comprising said machine learning software, said processor, and a communications interface, said stationary device (200) configured to calibrate said portable device (100), test said array of sensors (500) and emitters (400) for their accuracy, store said baseline treatment protocol and reference sensor (500) and emitter (400) positioning map in said master database and in said storage area of said portable device (100) prior to patient use, remotely control the operation of said portable device (100), and store information including data collected from an array of neural activity sensors worn on a patient during an applied stimulation session, and data collected from the array of sensors (500) worn on the patient prior to treatment application; and Equipped with - the computing unit (104) is further configured to modify the electromagnetic field applied through each of the arrays of emitters (400) simultaneously with the measurement of a biophysical signal from each of the arrays of sensors (500), each of the arrays of emitters (400) and each of the arrays of sensors (500) positioned in close proximity to one another are operating as a pair; - the electromagnetic field applied through each emitter (400) is successively modified until it is achieved that the measured biophysical signal by the paired sensor (500) is within the reference electromagnetic field range; A system characterized by:
2. The system of claim 1, wherein reference ranges of electromagnetic field strength and frequency are defined for each organ or tissue based on general or target cell type.
3. 2. The system of claim 1, wherein the computing unit is further configured to stop applying electromagnetic fields to all or some of the plurality of emitters based on the measured biophysical signal.
4. 2. The system of claim 1, wherein the machine learning software is further configured to modify the reference sensor (500) and emitter (400) positioning map and the baseline treatment protocol taking into account initial biophysical signals measured prior to use of the portable device (100).
5. 2. The system of claim 1, wherein each of the arrays of sensors (500) includes tissue impedance sensors, temperature sensors, electric and magnetic field sensors, skin conductivity sensors, permittivity and permeability sensors, and other biological, biochemical or biophysical sensors.
6. 2. The system of claim 1, wherein each of the array of emitters (400) comprises a coil selected from the group consisting of a solenoid / Tesla coil (304), a current supply loop (305), a current loop (306), a Helmholtz coil (307), a Maxwell coil (308), a solenoid cone (309), a variation of the current supply loop (310), or a combination thereof including different geometric shapes of the aforementioned coils.
7. 2. The system of claim 1, wherein the electromagnetic field applied through each of the array of emitters (400) is a constant or time-varying, uniform and / or non-uniform electromagnetic field.
8. The system of claim 1 , wherein the reference electromagnetic field range is defined for each organ, tissue, and cell type by its intensity, direction, duration of application, waveform, frequency, and amplitude.
9. 2. The system of claim 1, wherein the electromagnetic field applied through each of the array of emitters (400) to cause destructive, partially destructive, or constructive interference is of the opposite or same type of waveform as the waveform measured by each pair of sensors (500).
10. 10. The system of claim 9, wherein the electromagnetic field applied through each of the array of emitters (400) to cause destructive, partially destructive, or constructive interference is of a different or same amplitude or frequency as the waveform measured by each pair of sensors (500).
11. 11. The system of claim 1, wherein the portable device (100) includes a helmet, cap, or other headgear or arrangement for placement on or around a patient's head, and the array of sensors 500 and the array of emitters (400) are arranged to be mobile so that the electromagnetic field can be applied to areas of the brain affected by neurodegeneration, ischemia, injury, or inflammation.
12. The system of any one of claims 1 to 11, wherein the portable device (100) includes a custom enclosure attached to the patient, the enclosure having an extender for treating any tissue or organ, and the machine learning software calculates precise coordinates for an optimal position of the array of sensors (500) and emitters (400).
13. 13. The system of claim 12, wherein the custom enclosure comprises a casing having an adjustable pre-installed array of sensors (500) and emitters (400) that is movable along X, Y, and Z axes to position the array of sensors (500) and emitters (400) according to the baseline treatment protocol and an associated reference sensor (500) and emitter (400) positioning map.
14. 14. The system of any one of claims 1 to 13 for use in the treatment of diseases and conditions of the nervous system, cognitive disorders including epilepsy, bipolar disorder, schizophrenia, dementia, cardiac diseases, immunodeficiencies or autoimmune diseases, tumors, cancer and other oncological diseases, viral or bacterial infections, inflammatory diseases, diseases and conditions of muscle tissue, and diseases and conditions of connective tissue, and for stimulating an immune response following administration of a vaccine.
15. A portable device (100), an electromagnetic field generator configured to generate an electromagnetic field; an array of sensors (500) configured to measure a biophysical signal; an array of emitters (400) configured to apply an electromagnetic field; a storage area configured to store a baseline treatment protocol and a reference sensor (500) and emitter (400) positioning map; a computing unit (104) configured to record in real time a measured biophysical signal from each of the array of sensors (500) and to control the electromagnetic field generator to apply a plurality of different electromagnetic fields through the array of emitters (400) in order to compare the measured biophysical signals with a reference electromagnetic field range; A power source for the components of the portable device (100); Equipped with the computing unit (104) is further configured to modify an electromagnetic field applied through each of the array of emitters (400) simultaneously with measuring a biophysical signal from each of the array of sensors (500); Each of the arrays of emitters (400) and each of the arrays of sensors (500), positioned in close proximity to one another, operate as a pair, and the electromagnetic field applied through each emitter (400) is successively modified until it is achieved that the measured biophysical signal by the paired sensor (500) is within the reference electromagnetic field range. A portable device (100).
16. 16. The portable device (100) of claim 15, wherein the computing unit (104) is further configured to stop applying electromagnetic fields of all or some of the plurality of emitters (400) based on the measured biophysical signal.
17. 16. The portable device (100) of claim 15, wherein each of the array of sensors (500) includes a tissue impedance sensor, a temperature sensor, an electric and magnetic field sensor, a skin conductivity sensor, a permittivity and permeability sensor, or a combination thereof.
18. 16. The portable device (100) of claim 15, wherein each of the array of emitters (400) comprises a coil selected from the group consisting of a solenoid / Tesla coil (304), a current supply loop (305), a current loop (306), a Helmholtz coil (307), a Maxwell coil (308), a solenoid cone (309), a variation of the current supply loop (310), or a combination thereof including different geometric shapes of the aforementioned coils.
19. 16. The portable device (100) of claim 15, wherein the electromagnetic field applied through each of the array of emitters (400) is a constant or time-varying, uniform and / or inhomogeneous electromagnetic field.
20. 16. The portable device (100) of claim 15, wherein the reference electromagnetic field ranges are defined for each organ, tissue and cell type by their intensity, direction, duration of application, waveform, frequency and amplitude.
21. 16. The portable device (100) of claim 15, characterized in that the electromagnetic field applied through each of the array of emitters (400) to cause destructive, partially destructive or constructive interference is of the opposite or same type of waveform as the waveform measured by each pair of sensors (500).
22. 22. The portable device (100) of claim 21, wherein the electromagnetic field applied through each of the array of emitters (400) to cause destructive, partially destructive or constructive interference is characterized in that the waveform is of a different or the same amplitude or frequency as the waveform measured by each pair of sensors (500).
23. 23. The portable device (100) of any one of claims 15 to 22, further comprising a helmet, cap, or other headgear or arrangement for placement on or around a patient's head, wherein the array of sensors 500 and the array of emitters (400) are arranged to be movable so that the electromagnetic field may be applied to regions of the brain affected by neurodegeneration, ischemia, injury, or inflammation.
24. 23. The portable device (100) of any one of claims 15 to 22, further comprising a custom enclosure attached to a patient and with extenders for treating any tissue or organ, wherein machine learning software calculates precise coordinates for an optimal position of the array of sensors (500) and emitters (400).
25. 25. The portable device (100) of claim 24, wherein the custom enclosure comprises a casing having an adjustable pre-installed array of sensors (500) and emitters (400) that is movable along X, Y, and Z axes to position the array of sensors (500) and emitters (400) in accordance with the baseline treatment protocol and associated reference sensor (500) and emitter (400) positioning maps.
26. 26. A portable device according to any one of claims 15 to 25 for use in the treatment of diseases and conditions of the nervous system, cognitive disorders including epilepsy, bipolar disorder, schizophrenia, dementia, cardiac diseases, immunodeficiencies or autoimmune diseases, tumors, cancer and other oncological diseases, viral or bacterial infections, inflammatory diseases, diseases and conditions of muscle tissue, and diseases and conditions of connective tissue, and for stimulating an immune response following the administration of a vaccine.
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