Portable electromagnetic field muscle electrostimulation device

Abstract

The invention relates to a portable muscle electrostimulation device (1) for a patient comprising: an adaptable attachment element (1.1) for attaching said device to a part of the patient's body; an electronic circuit (EC) comprising an electrical power generation unit (EPU); characterized in that said electronic circuit is arranged to generate an electromagnetic or magnetic field (H) formed by a pulse train 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 electromagnetic field muscle electrostimulation device

[0001] The present invention relates to the technical field of muscle rehabilitation by adaptive electrostimulation using electromagnetic fields. In this field, it is known to use electrostimulation devices to treat muscle disorders, 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. Moreover, their use frequently requires the presence of a therapist to adjust the parameters, which restricts their accessibility and increases the overall cost of treatment.

[0002] Furthermore, current electrostimulation methods can be restrictive in terms of patient mobility and comfort. Stationary devices limit users to treatment sessions in medical settings or at home, without the possibility of continuous or ambulatory therapy. This limitation is particularly restrictive for those who could benefit from regular therapy throughout the day or in various circumstances, such as during light activities or at work. The constraints related to the complexity of the 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 treatment personalization 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. Furthermore, 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 muscle tone restoration device that is small, portable, and designed to prevent 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 muscle electrostimulation system. customizable and adaptive, designed to be used without direct supervision by a healthcare professional while ensuring safe and effective application of the treatment.

[0005] The invention aims to address this need by providing a portable device for the electrostimulation of a patient's muscles, comprising: a. an adaptable fastening element allowing said device to be fixed 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 of less than 1 mT (milliTesla), a frequency of less than 100 Hz and a pulse width of less than 100 ms (milliseconds).

[0006] The invention thus proposes to generate, under the influence of a periodic electrical current and voltage of predetermined frequency and intensity, a magnetic or electromagnetic field whose characteristics allow for the restoration of bodily tone, and in particular muscle tone, in the user for the entire duration of field application. Remarkably, the field characteristics are universal, that is to say, they have been shown to work for a wide range of individuals 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 patient's muscles and nervous system, thereby restoring muscle tone almost instantaneously and without causing discomfort or pain to the patient.Generating a magnetic field according to these specific parameters allows for targeted and effective treatment, thus contributing to better muscle recovery.

[0007] In the context of the present invention, an "adaptable fastening 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 supports. These elements are designed to hold the electrical muscle stimulation device in place during use, while adapting to the specific contours and size of the targeted body part, thus 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 that elapses between the beginning of a pulse and the beginning of the next 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, "single voltage pulse" means an electrical waveform characterized by a single voltage change that reaches a defined peak value and returns to zero without changing polarity.

[0010] In the context of the present invention, "bipolar voltage pulse" means an electrical waveform that 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 pulse train 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 pulse train with an intensity of less than 50 pT, or even less than 1 pT, or even less than 500 nT.

[0013] Preferably, the electronic circuit may be arranged to generate an electromagnetic or magnetic field formed by a pulse train with a frequency below 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, the electronic circuit may be arranged to generate an electromagnetic or magnetic field formed by a pulse train with a frequency below 10 Hz, or even below 5 Hz.

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

[0015] Advantageously, the electrical power generation unit is arranged to generate a periodic electric current, with a frequency of less than 100 Hz and a periodic electric voltage, with an amplitude of less than 10 V and a period of less than 10 s, the electrical circuit being arranged to generate said electromagnetic or magnetic field from said periodic electric current and / or said periodic electric 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 incorporates at least one coil in its electronic circuit. This This configuration generates a magnetic field induced by the flow of electric current through the coil. This arrangement optimizes the effectiveness of muscle stimulation by focusing the magnetic field's action on targeted areas of the patient's body. The electronic circuit should include at least one resistor connected in series with the coil, typically with a value of 100 ohms, 150 ohms, or 200 ohms.

[0017] In one embodiment of the invention, the adaptable fixation element comprises at least one retaining member for the device to a part of the patient's body, made of a stretchable material. The fixation 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 in 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 near a stimulation zone of said part of the patient's body when the device is attached to it. If applicable, the housing is without 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 a square or rectangular shape. Where appropriate, the electrical power generation unit may be arranged to generate a biphasic periodic electrical current, in particular so as to induce said magnetic or electromagnetic field.

[0021] Advantageously, the bipolar impulse, characterized by its alternation between two opposing 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 clearer transmission of the electrical signal, less susceptible to noise, 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 suited 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, generating the pulse train according to a pre-programmed emission pattern in the electronic circuit allows for advanced treatment personalization, adapting the stimulation to the patient's specific needs. The pre-programmed pattern can vary in intensity, frequency, and pulse duration, thus offering increased therapeutic flexibility.

[0026] This pre-programming ensures consistency and repeatability of stimulation sessions, contributing to the overall effectiveness of the treatment. Furthermore, the ability to predefine stimulation parameters allows healthcare professionals to design tailored treatment protocols, while also giving patients the opportunity 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 processing period.

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

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

[0030] Advantageously, the storage means allows monitoring of treatment parameters, promoting accurate evaluation of patient 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 user interaction with said interface, an activation signal 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 receiving 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, the field may be generated as long as the button is pressed, with 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 switch off after a predetermined treatment time.

[0033] Advantageously, the automatic shutdown of the device after a predetermined time 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 modification of the value of the parameters of an electric current and / or an electric voltage generated by the electrical power generation unit and of the electromagnetic or magnetic field generated by the electronic circuit.

[0035] Advantageously, this feature ensures simplicity and safety of use by avoiding inappropriate settings which could otherwise compromise the effectiveness of the treatment or the safety of the patient, while promoting an effective recovery 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 electrical current.

[0037] Of course, the different features, variants and embodiments of the invention can be combined with each other in various ways insofar as they are not incompatible or mutually exclusive.

[0038] In addition, various other features of the invention become apparent from the attached description made with reference to the drawings which illustrate non-limiting embodiments of the invention and where:

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

[0040] [Fig.2] represents, schematically and partially, an electronic circuit of the portable muscle electrostimulation device of [Fig.2] and the magnetic field generated by this circuit allowing to stimulate 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.1] over several periods;

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

[0043] [Fig.5] represents, schematically and partially, two signals of voltage enabling the generation of a magnetic field 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 including two indistinguishable portable muscle electrostimulation devices, according to an embodiment of the invention, in which only one of them was in operation.

[0045] Figure 1 illustrates an embodiment of the portable muscle electrostimulation device of the invention. This device is designed to be attached to a patient's wrist. The adjustable attachment element, referenced 1.1, is designed to ergonomically conform to 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 positioned in series with a coil.

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

[0047] The device is also equipped with a unique button that triggers the generation of a magnetic field via the coil when pressed.

[0048] Taken as a whole, this illustration demonstrates a compact, portable device designed with ergonomics in mind, making it comfortable for prolonged use. The device combines the essential components for electrostimulation in a practical form that can be integrated into clothing or accessories such as gloves, thus facilitating the regular application of therapy without hindering the patient's mobility or daily activities.

[0049] Figure 2 shows an electrical and functional diagram detailing the essential parts of the CE electronic circuit of the portable muscle electrostimulation device. At the heart of the system, the Electrical Power Generation Unit (EPU) is the power supply for the circuit. This unit is responsible for providing the current and voltage necessary to operate the other components. In the example described, the EPU is configured to generate a periodic electrical current with a frequency below 100 Hz and a periodic electrical voltage with an amplitude below 10 V and a period below 10 s.

[0050] The resistor, indicated by the symbol R, is connected in series with the coil and is involved in regulating 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 the 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 response of the The muscle in 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 comprises the UGPE, the resistor, and the coil. This combination of electronic components is arranged to control the delivery of electrostimulation safely and effectively. The EC circuit may include other components, not shown in [Fig. 2], and in particular components for regulating current and / or voltage, or for ensuring the safety of the device and its user.

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

[0054] 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 impulses emitted by the muscle electrostimulation device, is shown in [Fig.3].

[0055] The magnetic field is thus composed of a series of periodic pulses, each pulse reaching a peak between 400 and 500 microteslas (pT). Figure 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 on the order of 25 Hz.

[0057] Moreover, the width W of each pulse is significantly less than 100 milliseconds, which indicates 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 before falling back to a negative peak, with an intensity between -200 pT and -300 pT.

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

[0061] Two waveforms used for controlling muscle tension in the muscle electrostimulation device are shown in [Fig. 5]. These waveforms d'ondes 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 rises abruptly to a positive peak voltage value (+V_peak), is sustained for the pulse width W>0, and then returns to zero. This waveform represents a single-phase pulse, where the voltage remains positive and does not cross the zero baseline.

[0063] The second waveform, similar to the example in [Fig. 4], shows a bipolar pulse where the voltage rises to +V_peak, remains there for the pulse width W>0, falls to zero, then plunges to a negative peak voltage -V_peak and rises again 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 a complete pulse cycle, including the pulse itself plus any interval before the repetition of the next pulse. The pulse width W>0 is the time during which the peak voltage is maintained before falling 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, aiming to improve the recovery of muscle tone.

[0065] Figure 6 shows a bar graph comparing 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 mean values ​​measured for the "off" condition of the portable electrical muscle stimulation device, while the light gray bars represent the mean values ​​for the "on" condition of the device.

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

[0067] Variations can be observed in the force measurements 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 significant effect.

[0068] The diversity in the subjects' response 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 electrical stimulation device, a randomized, double-blind study was conducted, strictly following the protocol described below, the results of which are shown in [Fig. 6]. The trial cohort consisted of twenty subjects, each rigorously selected according to precise exclusion criteria to ensure suitability for the study objectives. These criteria ensured the exclusion of minors, subjects suffering from musculoskeletal or neurological disorders affecting the targeted upper limb, individuals who had undergone amputation of the limb in question, wearers of an electrical stimulation device, and pregnant women, in order to maintain the integrity and relevance of the study results.

[0072] In the study, visually identical portable muscle electrical stimulation devices were used, one activated while the other remained inactive. These devices were randomly and anonymously mixed, ensuring that neither the subjects nor the 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 KINVENT, a leading company in the field of medical devices. Each subject was assessed on the maximum and average force developed by the lateral epicondylar muscles over a period of five seconds, while maintaining an upright posture – a position that reflects the everyday conditions of use of the device.

[0074] The test protocol was divided into two distinct stages. The first, a control phase, consisted of three preliminary tests separated by fifteen seconds of rest. The purpose of this stage was to familiarize participants with the dynamometer and to standardize the test conditions. The second stage, the actual test phase, involved the use of 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 trial were meticulously recorded after each test session. The final disclosure of the status of each portable muscle electrical stimulation device, activated or deactivated, was only made after all tests had been completed, thus preserving the blinding of the study until the last measurement. This method ensured that the results were free from 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 in strength 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] The data analysis in the study on the portable muscle electrostimulation device highlights its effect on the muscle strength of the subjects tested. 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 mean values ​​for the group equipped with the active device compared to the control group, suggesting an improvement in muscle strength when the device is in use. 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 not only exhibits a higher average but also higher minimum and maximum values ​​than the control group. This indicates that 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, the median of the active device group being higher than that of the control group, and the interquartile range indicates 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 can be made to the invention within the scope of the annexed claims.

Claims

Demands

1. A portable patient electrical muscle stimulation device (1) comprising: a. an adaptable attachment element (1.1) for attaching said device (1) to a part of the patient's body; b. an electronic circuit (EC) comprising an electrical power generation unit (EPU); wherein said electronic circuit (EC) is arranged to generate an electromagnetic or magnetic field (H) formed by a pulse train having an intensity of less than 1 mT, a frequency of less than 100 Hz and a pulse width of less than 100 ms; characterized in that said electronic circuit (EC) is arranged such that: • the pulse train has a frequency of less than 50 Hz and greater than or equal to 20 Hz; • the pulse train has a pulse width of less than 50 ms; and • the pulse train has an intensity of less than 500 nT.

2. A portable patient muscle electrostimulation device (1) 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).

3. A portable (1) patient muscle electrostimulation device according to any one of the preceding claims, wherein the adaptable attachment element (1.1) comprises at least one device for retaining the device to a part of the patient's body made of an extensible material.

4. A portable (1) patient muscle electrostimulation device according to any one of the preceding claims, characterized in that the electrical voltage generated by said electrical power unit (EPU) is a bipolar pulse.

5. A portable (1) patient muscle electrostimulation device according to any one of the preceding claims, wherein The electrical power generation unit (EPU) is arranged to generate said pulse train by following a pre-programmed emission pattern in the electrical circuit.

6. A portable (1) patient muscle electrostimulation device 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 to the electrical power generation unit (EPU) 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.

7. A portable patient muscle electrostimulation device (1) according to the preceding claim, wherein said device is configured to automatically switch off after a predetermined treatment time.

8. A portable (1) patient muscle electrostimulation device according to any one of claims 5 or 6, characterized in that the device is devoid of an interface allowing modification of the value of the parameters of an electric current and / or an electric voltage generated by the electrical power generation unit (EPU) and of the electromagnetic or magnetic field generated by the electronic circuit (EC).

9. A portable (1) patient muscle electrostimulation device according to any one of the preceding claims, characterized in that it comprises a self-contained electrical power source, the electrical power generation unit (EPU) being arranged to convert the electrical energy supplied by the electrical power source into said electrical current.

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