Portable electromagnetic field muscle electrostimulation device

Abstract

The invention relates to a portable device (1) for muscular electrostimulation of a patient comprising: an adaptable fixing element (1.1) making it possible to fix said device to a part of the patient's body; an electronic circuit (CE) comprising an electrical power generation unit (UGPE); characterized in that said electronic circuit is arranged to generate an electromagnetic or magnetic field (H) formed by a train of pulses having an intensity of less than 1 mT, a frequency of less than 100 Hz and a pulse width of less than 100 ms.

Description

Title of the invention: Portable device for electrostimulation of muscles with electromagnetic field

[0001] The present invention relates to the technical field of muscle rehabilitation by adaptive electrostimulation via electromagnetic fields. In this field, it is known to use electrostimulation devices to treat muscle conditions, chronic pain, particularly of neuromuscular origin, and to improve muscle tone. However, existing technologies are often criticized for their lack of adaptability to different users and their specific conditions. Traditional devices are generally designed according to a "one size fits all" approach, not sufficiently taking into account the anatomical and physiological differences between patients. In addition, their use frequently requires the presence of a therapist to adjust the parameters, which restricts their accessibility and increases the overall cost of the treatment.

[0002] Furthermore, current methods of electrostimulation can be restrictive in terms of patient mobility and comfort. Stationary devices limit users to treatment sessions in medical or home environments, without the possibility of continuous or ambulatory therapy. This limitation is particularly burdensome for those who could benefit from regular therapy throughout the day or in different circumstances, such as during light activities or at work. Constraints related to the complexity of settings and the need for heavy and unwieldy equipment reduce the adoption and effectiveness of electrostimulation treatments.

[0003] Existing systems have several drawbacks, such as the need for stationary equipment, the lack of customization of treatments based on individual physiological responses, and the risk of incorrect use by the end user, which can lead to inappropriate or even harmful muscle stimulation applications. In addition, most current devices are expensive and involve additional costs for professional assistance, making treatment unaffordable for many patients.

[0004] There is therefore a need for a device for restoring muscle tone that is small, portable and designed to avoid mishandling. Such a device should minimize the risk of exposing patients to harmful doses of stimulation and offer a non-invasive and inexpensive treatment. The invention aims to meet this need by providing a customizable and adaptive muscle electrostimulation system, designed to be used without direct supervision of a healthcare professional. health while ensuring safe and effective application of the treatment.

[0005] The invention proposes to meet this need by proposing a portable device for electrostimulating the muscles of a patient comprising: a. an adaptable fixing element for fixing said device to a part of the patient's body; b. an electronic circuit comprising an electrical power generation unit; characterized in that said electronic circuit is arranged to generate an electromagnetic or magnetic field formed by a train of pulses having an intensity less than 1 mT (milliTesla), a frequency less than 100 Hz and a pulse width less than 100 ms (milliseconds).

[0006] The invention thus proposes to generate, under the influence of a current and a periodic electric voltage whose frequency and intensity are predetermined, a magnetic or electromagnetic field whose characteristics make it possible to restore the body tone and in particular the muscle tone of the user throughout the duration of application of the field. Remarkably, the characteristics of the field are universal, that is to say they have been demonstrated to work for a large number of profiles of people and for any type of muscle and any type of physiological cell. Advantageously, the application of the low-intensity magnetic field generated by said electronic circuit is thus suitable for gentle and non-invasive stimulation of the muscles and the nervous system of the patient, which makes it possible to restore muscle tone substantially instantly and without causing discomfort or pain to the patient.The generation of a magnetic field according to these specific parameters thus allows targeted and effective treatment, thus contributing to better muscle recovery.

[0007] In the context of the present invention, an "adaptable attachment element" means a component designed to be adjusted or modified to fit securely and comfortably to different parts of the patient's body. This may include, for example, adjustable straps, elastic sleeves, or customizable adhesive backings. These elements are designed to hold the muscle electrostimulation device in place during use, while adapting to the specific contours and size of the targeted body part, thereby ensuring effective and stable contact for treatment delivery.

[0008] In the context of the present invention, the term "period T of the signal" means the time interval of duration T which elapses between the start of a pulse and the start of the following pulse. It encompasses not only the duration of the pulse but also the rest interval between two consecutive pulses.

[0009] In the context of the present invention, the term “single pulse of voltage » an electrical waveform characterized by a single change in voltage that reaches a defined peak value and returns to zero without changing polarity.

[0010] In the context of the present invention, the term "bipolar voltage pulse" means an electrical waveform which oscillates between a positive peak voltage and a negative peak voltage, thus producing an alternation of polarity within the same cycle.

[0011] Advantageously, the electronic circuit is arranged to generate, under the influence of the current and / or the electrical voltage generated by the electrical power generation unit, an electromagnetic or magnetic field formed by a train of pulses having an intensity less than or equal to 100 pT, a frequency less than or equal to 50 Hz and a pulse width less than or equal to 100 ms.

[0012] Preferably, the electronic circuit may be arranged to generate an electromagnetic or magnetic field formed by a train of pulses having an intensity of less than 50 pT, or even less than 1 pT, or even less than 500 nT.

[0013] Still preferably, the electronic circuit may be arranged to generate an electromagnetic or magnetic field formed by a train of pulses having a frequency of less than 50 Hz, and in particular greater than or equal to 20 Hz. The frequency may for example be 20 Hz, 33 Hz, 40 Hz or 50 Hz. Alternatively, it may be provided that the electronic circuit is arranged to generate an electromagnetic or magnetic field formed by a train of pulses having a frequency of less than 10 Hz, or even less than 5 Hz.

[0014] Preferably still, the electronic circuit may be arranged to generate an electromagnetic or magnetic field formed by a train of pulses having a pulse width less than or equal to 100 ms, or even less than 50 ms.

[0015] Advantageously, the electrical power generation unit is arranged to generate a periodic electrical current, of frequency less than 100 Hz and a periodic electrical voltage, of amplitude less than 10 V and of period less than 10 s, the electrical circuit being arranged to generate said electromagnetic or magnetic field from said periodic electrical current and / or said periodic electrical voltage.

[0016] In one embodiment of the invention, the electronic circuit comprises at least one coil, such that the electromagnetic field generated by said electronic circuit is a magnetic field induced by the flow of electric current in said at least one coil. Advantageously, the portable muscle electrostimulation device integrates at least one coil in its electronic circuit. This configuration makes it possible to generate a magnetic field induced by the flow of electric current circulating in the coil. This arrangement optimizes the effectiveness of muscle stimulation, by focusing the action of the magnetic field on the targeted areas of the patient's body. It may be provided that the electronic circuit includes at least one resistor connected in series with said coil, in particular with a value of 100 Ohm, 150 Ohm or 200 Ohm.

[0017] In one embodiment of the invention, the adaptable fixing element comprises at least one member for holding the device to a part of the patient's body made of an extensible material. The fixing element thus allows adaptation to different sizes and shapes of body parts.

[0018] Advantageously, this adaptability ensures that the device can be used on different parts of the body, as well as by patients of different morphologies, making the device more universal and practical to use for restoring muscle tone.

[0019] Preferably, the device comprises a housing within which the electronic circuit is arranged, the adaptable attachment element being connected to the housing so that a stimulation zone is placed in contact with or close to a stimulation zone of said part of the patient's body when the device is attached thereto. Where appropriate, the housing is devoid of electrodes intended to come into contact with said part of the patient's body.

[0020] In one embodiment of the invention, the electrical voltage generated by the electrical power unit is a bipolar pulse, in particular of square or rectangular shape. Where appropriate, it may be provided that the electrical power generation unit is arranged to generate a biphasic periodic electrical current, in particular so as to induce said magnetic or electromagnetic field.

[0021] Advantageously, the bipolar pulse, characterized by its alternation between two opposite voltage levels, is particularly effective in inducing controlled muscle contractions. This characteristic reduces the risk of undesirable reactions, such as muscle fibrillation, by maintaining a balance in the distribution of the electrical current.

[0022] Furthermore, the bipolar pulse allows for a clearer and less noisy transmission of the electrical signal, thus improving the quality and effectiveness of the stimulation. This technology clearly distinguishes the bipolar pulse from unipolar pulses which use a single voltage level, thus offering a more refined stimulation method adapted to specific muscle treatments.

[0023] In an alternative embodiment of the invention, the electrical voltage generated by the electrical power unit is a unipolar pulse.

[0024] In one embodiment of the invention, the electrical power generation unit is arranged to generate said pulse train by following a pre-programmed emission pattern in the electrical circuit.

[0025] Advantageously, the generation of the pulse train according to a pre-programmed emission pattern in the electronic circuit allows advanced personalization of the treatment, adapting the stimulation to the specific needs of the patient. The pre-programmed pattern programmed can vary in intensity, frequency, and pulse duration, providing increased therapeutic flexibility.

[0026] This pre-programming ensures consistency and repeatability of stimulation sessions, contributing to the overall effectiveness of the treatment. In addition, the ability to pre-set stimulation parameters allows healthcare professionals to design tailored treatment protocols, while giving patients the ability to perform electrostimulation sessions independently, with optimal safety and effectiveness.

[0027] In one embodiment of the invention, the electronic circuit is arranged to automatically generate the electromagnetic or magnetic field at regular intervals during a predetermined treatment period.

[0028] Advantageously, the automatic generation of the field at regular intervals ensures constant application of the treatment, which is crucial for the progressive and uniform restoration of the patient's muscle tone.

[0029] In a cumulative embodiment of the invention, the portable muscle electrostimulation device includes a storage means for recording the treatment parameters used during each electrostimulation session.

[0030] Advantageously, the storage means allows monitoring of treatment parameters, promoting precise evaluation of the patient's progress and the possibility of refining treatment protocols for optimal muscle recovery.

[0031] In one embodiment of the invention, the device comprises an activation interface capable of generating, in response to an interaction of a user with said interface, an activation signal intended for the electrical power generation unit and the electrical power generation unit is arranged to generate said periodic electrical current and voltage in response to the reception of said activation signal. The device may thus be equipped with a single button intended to trigger, when pressed, the generation of the magnetic or electromagnetic field. For example, it may be provided that the field is generated as long as the button is pressed, releasing the button stopping the generation of the field.

[0032] In one embodiment of the invention, the portable muscle electrostimulation device is configured to automatically turn off after a predetermined treatment duration.

[0033] Advantageously, the automatic shutdown of the device after a predetermined duration minimizes the risk of muscle overstimulation, ensuring safe and controlled treatment for the restoration of muscle tone.

[0034] In one embodiment of the invention, the portable electrostimulation device is devoid of an interface allowing the value of the parameters of a current to be modified. electric and / or electric voltage generated by the electric power generation unit and the electromagnetic or magnetic field generated by the electronic circuit.

[0035] Advantageously, this feature ensures simplicity and safety of use by avoiding inappropriate adjustments which could otherwise compromise the effectiveness of the treatment or the safety of the patient, while promoting effective restoration of muscle tone.

[0036] In one embodiment of the invention, the device comprises an autonomous electrical energy source, the electrical power generation unit being arranged to convert the electrical energy supplied by the electrical energy source into said electric current.

[0037] Of course, the various features, variants and embodiments of the invention may be combined with each other in various combinations to the extent that they are not incompatible or mutually exclusive.

[0038] Furthermore, various other characteristics of the invention emerge from the appended description given with reference to the drawings which illustrate non-limiting forms of embodiment of the invention and where:

[0039] [Fig.l] represents, schematically and partially, a portable device for muscular electrostimulation according to an embodiment of the invention;

[0040] [Fig.2] represents, schematically and partially, an electronic circuit of the portable device for muscle electrostimulation of [Fig.2] and the magnetic field generated by this circuit allowing the stimulation of the nervous and muscular system of a patient;

[0041] [Fig.3] represents, schematically and partially, the magnetic signal produced by the portable muscle electrostimulation device of [Fig.l] over several periods;

[0042] [Fig.4] represents, schematically and partially, a portion of the signal of the [Fig.3] for a period;

[0043] [Fig.5] represents, schematically and partially, two voltage signals allowing a magnetic field to be generated by the portable muscle electrostimulation device according to [Fig.l];

[0044] [Fig.6] represents, schematically and partially, the comparison of the means of several patients in a randomized, double-blind study comprising two indistinguishable portable muscle electrostimulation devices, according to an embodiment of the invention, for which only one of them was running.

[0045] [Fig.l] shows an exemplary embodiment of the portable muscle electrostimulation device of the invention. This device is designed to be attached to a patient's wrist. The adaptable attachment element, referenced 1.1, is designed to ergonomically fit the shape of the wearer's wrist. The CE electronic circuit is housed in the center of the device and includes at least one resistor that is positioned so as to be in series with a coil.

[0046] The CE electronic circuit is the unit responsible for generating electrical power for electrostimulation. The resistance is used to control the intensity of the electrical current flowing through the coil, which is then able to generate a magnetic field around the wearer's wrist.

[0047] The device is also equipped with a single button to trigger the generation of a magnetic field via the coil when pressed.

[0048] Overall, this illustration demonstrates a compact, ergonomically designed handheld device that makes it comfortable for extended use. The device combines the essential components for electrostimulation into a convenient form that can be integrated into clothing or accessories such as gloves, thereby facilitating regular application of therapy without impeding the patient's mobility or daily activity.

[0049] In [Fig.2] is shown an electrical and functional diagram which details the essential parts of the CE electronic circuit of the portable muscular electrostimulation device. At the heart of the system, the Electrical Power Generation Unit (EPU) is the electrical power source of the circuit. This unit is responsible for providing the current and voltage necessary to operate the other components. In the example described, the EPU unit is arranged to generate a periodic electric current, of frequency less than 100 Hz and a periodic electric voltage, of amplitude less than 10 V and period less than 10 s.

[0050] The resistor, indicated by the symbol R, is connected in series with the coil and is involved in regulating the intensity of the current flowing through the latter. The coil, marked S, is the active element which, when powered by the periodic electric current supplied by the UGPE, generates a magnetic field H. This field is illustrated by flux lines surrounding the coil, indicating the direction and strength of the magnetic field, which is used to stimulate nerves and muscles.

[0051] In the immediate vicinity of this magnetic field, we observe the representation of a neuron, designated by N, which demonstrates the interaction of the field with the nervous system. This interaction is the basis of muscle stimulation, where the neuron acts as an intermediary between the magnetic field and the muscle, represented by M. The muscle's response to this field is what causes contraction and contributes to muscle rehabilitation.

[0052] The circuit as a whole is identified as the Electronic Circuit (EC) and includes the UGPE, the resistor and the coil. This combination of electronic components is organized to control the delivery of the electrostimulation in a manner safe and efficient. It may be provided that the CE circuit includes other components, not shown in [Fig.2], and in particular components intended for regulating the current and / or voltage, or intended to ensure the safety of the device and its user.

[0053] Finally, the diagram also shows a grounding element, denoted GND, indicating that the device is designed with an appropriate grounding system to ensure the safety of the user and the proper functioning of the device.

[0054] [Fig.3] shows a graph illustrating the variation of the magnetic field generated by the electrical circuit CE as a function of time, corresponding to the description of the magnetic pulses emitted by the muscle electrostimulation device.

[0055] The magnetic field is thus composed of a series of periodic pulses, each pulse reaching a peak between 400 and 500 microteslas (qT). [Fig.4] represents one of these pulses.

[0056] The pulses are separated by a substantially constant period T, so that the frequency of the pulse train is less than 50 Hz, in particular of the order of 25 Hz.

[0057] Furthermore, the width W of each pulse is significantly less than 100 milliseconds, indicating that the duration during which the magnetic field is at its maximum is very brief and followed by a period of inactivity before the next pulse.

[0058] Thus, the device produces a low intensity magnetic field, but with a controlled frequency and pulse width, optimizing the therapeutic effect of muscle electrostimulation.

[0059] As shown in [Fig.4], each pulse is bipolar and reaches a peak intensity between 400 pT and 500 pT and then falls back to a negative peak, with an intensity between -200 pT and -300 pT.

[0060] The total width W of the pulse is 20 ms. This pulse width corresponds to the duration during which the magnetic field is significantly different from zero. The shape of the pulse contributes to a gentle application of the magnetic field, which reduces the risk of overly intense stimulation, thus contributing to the safety and comfort of the patient.

[0061] [Fig.5] shows two waveforms used for controlling muscle tension in the muscle electrostimulation device. These waveforms correspond to voltage signals delivered to the terminals of the UGPE unit to generate the magnetic field.

[0062] The first waveform is a single pulse that abruptly rises to a positive peak voltage value (+V_peak), holds for the pulse width W>0, and then returns to zero. This waveform represents a monophasic pulse, where the voltage remains positive and does not cross the baseline zero.

[0063] The second waveform, similar to the example in [Fig.4], shows a bipolar pulse where the voltage rises to +V_peak, holds for the pulse width W>0, falls back to zero, then dips to a negative peak voltage -V_peak and rises back to zero. This biphasic waveform has two distinct phases, positive and negative, with the voltage changing polarity during the signal period T>0.

[0064] In both configurations, the period T is the total time for one complete cycle of the pulse, including the pulse itself plus any interval before the next pulse is repeated. The pulse width W>0 is the time for which the peak voltage is maintained before falling back to zero. Monophasic and biphasic waveforms are essential for generating a variable magnetic field, with specific characteristics that can be adjusted to tailor the treatment to individual patient needs, aimed at improving muscle tone recovery.

[0065] [Fig. 6] shows a bar graph that compares two sets of data represented by dark gray and light gray bars. Each pair of bars corresponds to a measurement for one of the 20 subjects tested in the study. The dark gray bars represent the average values measured for an “off” condition of the portable muscle electrostimulation device, while the light gray bars represent the average values for another “on” condition of the device.

[0066] The graph is divided into 20 segments, corresponding to the 20 subjects in the study. The values on the vertical axis (V) are a measure of force in newtons while the horizontal axis numbers the study subjects from 1 to 20.

[0067] Variations in the force measurements may be noted between the two conditions for each subject. In some cases, the light gray bars exceed the dark gray bars, suggesting an increase in force when using the device, while in others, the measurements are similar between the two conditions, which could indicate a lack of a significant effect.

[0068] The diversity in the response of the subjects may suggest individual variability in the reaction to the device, which could be due to physiological differences or varying degrees of receptivity to electromagnetic stimulation.

[0069] It should be noted that in these figures the structural and / or functional elements common to the different variants may have the same references.

[0070] Experimental protocol and double-blind clinical study

[0071] To empirically evaluate the performance of the portable muscle electrostimulation device, a double-blind randomized study was conducted, strictly following the protocol described below and the results of which are shown in [Fig.6]. Twenty subjects constituted the test cohort, each of whom was ri carefully selected according to precise exclusion criteria to ensure adequacy with the objectives of the study. These criteria ensured the exclusion of minors, subjects suffering from musculoskeletal or neurological disorders affecting the targeted upper limb, individuals with amputations of the affected limb, wearers of electrostimulation devices, as well as pregnant women, in order to maintain the integrity and relevance of the study results.

[0072] In the study, visually identical handheld muscle electrostimulation devices were used, with one activated while the other remained inert. These devices were randomly and anonymously mixed, ensuring that neither subjects nor test administrators could distinguish the active device from its inactive counterpart. This randomization procedure eliminates any potential bias related to device selection.

[0073] The force measurements were carried out using an electronic dynamometer supplied by the company KINVENT, a reference in the field of medical devices. Each subject was evaluated on the maximum and average force developed by the lateral epicondylar muscles over a period of five seconds, while maintaining a standing posture - a position which reflects the daily conditions of use of the device.

[0074] The test protocol was broken down into two distinct stages. The first, a control phase, consisted of three preliminary tests spaced fifteen seconds apart. This stage was intended to accustom the participants to the dynamometer and to standardize the test conditions. The second stage, the actual test phase, involved the use of the portable muscle electrostimulation devices according to a repeated test protocol, alternating between the two devices with an identical rest interval.

[0075] The results of the test were meticulously recorded after each test session. The final disclosure of the state of each portable muscle electrostimulation device, activated or deactivated, was only made after the tests were completely completed, thus preserving the blinding of the study until the last measurement. This method ensured that the results were free from any confirmation or expectation bias, both on the part of the subjects and the researchers.

[0076] By analyzing the collected data, the generated graphs clearly depict the variance of the forces measured during the control and test phases. These visual representations allow for easier interpretation of muscle performance under the influence of the portable muscle electrostimulation device, compared to the resting state. Examination of these graphical data revealed statistically significant differences between the groups, indicating a potential effect of the device on the subjects' muscle strength.

[0077] Data analysis in the study on the portable muscle electrostimulation device highlights its effect on the muscle strength of the test subjects. The data, structured in two columns, reflect the average strength measurements obtained from two different groups: a control group and a group subjected to activation of the portable muscle electrostimulation device.

[0078] Descriptive statistics reveal higher means for the group equipped with the active device compared to the control group, suggesting an improvement in muscle strength when the device is in operation. The standard deviations, similar for both groups, indicate comparable variability in muscle responses within each group, suggesting that the effect of the device does not vary significantly between subjects.

[0079] Examining the extreme values, it is noted that the group with the active device presents not only a higher average but also higher minimum and maximum values than the control group. This indicates that the activation of the device has an overall positive effect on muscle strength, without causing extremely high or low responses that could suggest instability in its action.

[0080] Quartile analysis confirms the trend observed with the means, with the median of the active device group being higher than that of the control group, and the interquartile range indicating a slightly wider range of responses.

[0081] The conclusions drawn from the analysis suggest a favorable trend towards the use of the active device in terms of improving muscle strength.

[0082] Of course, various other modifications may be made to the invention within the scope of the appended claims.

Claims

Claims

1. Portable device (1) for electrostimulating the muscles of a patient comprising: a. an adaptable fixing element (1.1) for fixing said device (1) to a part of the patient's body; b. an electronic circuit (CE) comprising an electrical power generation unit (UGPE); characterized in that said electronic circuit (CE) is arranged to generate an electromagnetic or magnetic field (H) formed by a train of pulses having an intensity of less than 1 mT, a frequency of less than 100 Hz and a pulse width of less than 100 ms.

2. Portable device (1) for electrostimulating the muscles of a patient according to claim 1, characterized in that the electronic circuit (CE) is arranged to generate an electromagnetic or magnetic field (H) formed by a train of pulses having an intensity of less than 100 pT, a frequency of less than 50 Hz and a pulse width of less than 100 ms.

3. Portable device (1) for electrostimulating the muscles of a patient according to claim 1, characterized in that the electronic circuit (CE) comprises at least one coil (S) and in that said electromagnetic field is a magnetic field (H) induced by the flow of electric current in said at least one coil (S).

4. Portable device (1) for electrostimulating the muscles of a patient according to one of the preceding claims, in which the adaptable fixing element (1.1) comprises at least one member for holding the device to a part of the patient's body made of an extensible material.

5. Portable device (1) for electrostimulating the muscles of a patient according to one of the preceding claims, characterized in that the electrical voltage generated by said electrical power unit (UGPE) is a bipolar pulse.

6. Portable device (1) for electrostimulating the muscles of a patient according to any one of the preceding claims, in which the electrical power generation unit (UGPE) is arranged to generate said train of pulses by following a preprogrammed emission pattern. in the electrical circuit.

7. Portable device (1) for electrostimulating the muscles of a patient according to any one of the preceding claims, characterized in that it comprises an activation interface capable of generating, in response to an interaction of a user with said interface, an activation signal intended for the electrical power generation unit (UGPE) and in that the electrical power generation unit is arranged to generate said periodic electrical current and voltage in response to the reception of said activation signal.

8. Portable device (1) for electrostimulating the muscles of a patient according to the preceding claim, in which said device is configured to automatically switch off after a predetermined treatment duration.

9. Portable device (1) for electrostimulating the muscles of a patient according to any one of claims 6 or 7, characterized in that the device has no interface allowing modification of the value of the parameters of an electric current and / or an electric voltage generated by the electric power generation unit (UGPE) and of the electromagnetic or magnetic field generated by the electronic circuit (CE).

10. Portable device (1) for electrostimulating the muscles of a patient according to any one of the preceding claims, characterized in that it comprises an autonomous source of electrical energy, the electrical power generation unit (UGPE) being arranged to convert the electrical energy supplied by the source of electrical energy into said electrical current.

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