Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/02—Details
  • A61N1/04—Electrodes
  • A61N1/0404—Electrodes for external use
  • A61N1/0408—Use-related aspects
  • A61N1/0452—Specially adapted for transcutaneous muscle stimulation [TMS]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
  • A61B5/316—Modalities, i.e. specific diagnostic methods
  • A61B5/389—Electromyography [EMG]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/02—Details
  • A61N1/04—Electrodes
  • A61N1/0404—Electrodes for external use
  • A61N1/0408—Use-related aspects
  • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/02—Details
  • A61N1/04—Electrodes
  • A61N1/0404—Electrodes for external use
  • A61N1/0472—Structure-related aspects
  • A61N1/0476—Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36003—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36014—External stimulators, e.g. with patch electrodes
  • A61N1/3603—Control systems
  • A61N1/36031—Control systems using physiological parameters for adjustment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36014—External stimulators, e.g. with patch electrodes
  • A61N1/3603—Control systems
  • A61N1/36034—Control systems specified by the stimulation parameters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
  • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
  • A61B5/0531—Measuring skin impedance
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
  • A61B5/316—Modalities, i.e. specific diagnostic methods
  • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
  • A61B5/316—Modalities, i.e. specific diagnostic methods
  • A61B5/369—Electroencephalography [EEG]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
  • A61B5/4029—Detecting, measuring or recording for evaluating the nervous system for evaluating the peripheral nervous systems
  • A61B5/4035—Evaluating the autonomic nervous system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
  • A61B5/4029—Detecting, measuring or recording for evaluating the nervous system for evaluating the peripheral nervous systems
  • A61B5/4041—Evaluating nerves condition
  • A61B5/4052—Evaluating nerves condition efferent nerves, i.e. nerves that relay impulses from the central nervous system

Definitions

• the present invention relates to the field of neuro-muscular stimulation consisting in causing the triggering, by electrical, magnetic or haptic pulses, of the muscular contraction of a muscle affected by paresis by central lesion or by damage to the peripheral nerve.
• the denervated muscle loses its activity, which has consequences on its structure and its trophicity with atrophy of the muscle fibers. These modifications start from the first week following denervation and are predominant during the first month.
• the stimulation of a denervated muscle differs from that of a healthy muscle in that the activation of muscle fibers requires specific stimuli.
• the measurement of chronaxies makes it possible to establish whether the denervation is weak, partial or total.
• excito-motor treatment is to maintain trophism and limit muscular sclerosis to allow the muscle to be as functional as possible at the end of the re-innervation process which can sometimes last several months.
• the pulses are generated by a device and transmitted by electrodes placed on the skin in the immediate vicinity of the muscles to be stimulated or by haptic or magnetic excitations.
• the pulses mimic the action potential from the central nervous system, causing a muscle sensory biofeedback, including muscle contraction.
• Neuro-muscular electrical stimulation is generally used as a therapeutic intervention for muscle building. It can be used to increase the strength of an injured or healthy muscle. It is generally used on the superficial muscles of the arms, shoulder girdle, perineal or abdominal, legs and lower back.
• An isolated lesion with specific reductions in muscle strength, such as weakness of the quadriceps or lumbar artery or pelvic muscles is the most common degradation treated by neuromuscular electrical stimulation (NMS) to allow contraction of paralyzed muscles.
• NMS neuromuscular electrical stimulation
• a lesion of the central nervous system of medullary origin which can cause paraplegia, or of cerebral origin (stroke) which can cause hemiplegia or even originate from other neuromotor disorders. It is also used in the field of sport for training the muscles and recovering them after exercise.
• EMG electromyography
• Devices using EMG to control electrical stimulation of a given muscle require placing on said muscle either five different and specific electrodes, including two electrodes for electrical stimulation and three electrodes for EMG, or a combination of at least three electrodes, including two active electrodes for stimulation and for EMG measurement and a reference electrode grounded and grounded.
• the electrodes used in this type of device must provide a uniform electrical distribution on the skin of a person under the entire surface of the electrode, in other words a constant current density per unit area of the electrode to ensure coupling. correct. Due to the natural curves inherent in the human body, it is obvious that the electrodes must not only be flexible to adhere perfectly to the contours of the skin under the electrode, but also to accommodate the relative movements of the person's skin.
• Stimulation can also be achieved by mechanical vibrations applied to the patient's skin in the vicinity of the muscle to be rehabilitated, or by magnetic excitations.
• EP3315168 which describes a neurostimulation system in the context of the restoration of locomotion in patients suffering from a spinal cord injury (SCI) is known in the prior art and consists in electrically stimulating the spinal cord during a voluntary and / or assisted walk.
• This patent proposes to administer epidural stimulation of the electrical spinal cord based on brain activity controlled by a neurosensor, such as a network of electrodes. In this way, the application of electrical stimulation can be controlled in a closed loop in response to changes in brain activity.
• the method described in this patent aims, in a first mode, to monitor the activity of the motor cortex while not stimulating any nerve fibers and, in a second mode, by stimulating the nerve fiber (s) and monitor the activity of the motor cortex during and after stimulation of the nerve fiber (s).
• This solution relates to a context totally different from the invention, namely the use of cortex activity signals to control non-denervated muscles, in cases of spinal cord injury, while the invention on the contrary relates to the reeducation of a muscle, in particular denervated from a patient whose nervous system presents no disorder.
• This prior art document therefore has no relevance with regard to the invention which is the subject of this patent.
• Patent application US20180036531 relates to a system for controlling stimulation pulses.
• Stimulation pulses are known in the art, in particular electrical muscle stimulation (EMS) or vibration to stimulate various biological tissues such as muscles and nerves. The goal is to allow athletes to learn, train or improve optimal movement sequences.
• EMS electrical muscle stimulation
• This prior art solution relates to a device for controlling stimulation pulses during stimulation on a user, comprising a sensor, at least one data processing unit and at least one pulse unit, in which
• the senor is suitable for measuring one or more measured values
• the data processing unit is configured to generate a control signal to the pulse unit as a function of the measured value or values of the sensor or sensors
• the pulse unit is capable of triggering stimulation pulses and is configured to vary one or more stimulation pulse parameters according to the control signal, in particular when the control signal is generated, a comparison between the measured value (s) and the threshold is performed.
• This document does not relate to the rehabilitation of a muscle, in particular denervated, but the learning of sequences of movements by stimulation cycles aimed at creating reflexes for a user without muscular disorders.
• Patent application US20180001086 describes flexible sheets that can be used in systems, methods and devices for neuromuscular stimulation, detection and recording.
• Such systems are used to receive thought signals indicating an intentional action and to provide electrical stimulation to the nerves and / or muscles in order to perform the intended action, thereby bypassing or assisting a damaged or degenerate region / pathway of the system. nervous.
• the flexible sheets of the present description can be used to make neuromuscular stimulation cuffs, also called here "neural sleeves", which deliver stimulation to restore movement in parts of the body not under voluntary control due to neural regions / pathways. damaged or degenerated, brain or spinal cord injury, stroke, nerve damage, neuromotor disease and other conditions
• the system can also be used in a patient with local degeneration of neurons or muscles for therapeutic or rehabilitative purposes.
• Patent application W02016196784 describes a process for the rehabilitation of a patient with a motor impairment, comprising the steps consisting in:
• the intention to move is captured by different sensors and the stimulation is not specific to a given muscle but to a set of muscles concerned by the intention to move.
• the invention relates, according to its most general meaning, to a method of muscular stimulation consisting in applying via skin electrodes pulse sequences characterized in that the triggering of a sequence of pulses is controlled by the detection of a physiological signal of muscular biological feedback from a subject, the frequency of the pulses being between 0.5 Hz and 200 Hz.
• physiological a bioelectric or mechanical signal produced by the activation of a measured muscle, voluntarily by the decision of a subject actively participating in exercise and / or involuntarily (for example, after activation
• An electroencephalographic (EEG) or electro-spinal signal is not assimilated to a physiological biological muscle feedback signal within the meaning of this patent because it does not make it possible to discern a particular muscle to be rehabilitated and does not make it possible to detect activation. of a denervated muscle.
• the stimulations are either of the electrical type and applied by electrodes formed by elements conducting electric current, or of the mechanical type, under the form of transcutaneous vibration stimulation from 30 to 100 hours applied by electrodes constituted in this case by transducers, for example piezoelectric transducers.
• electrode covers, within the meaning of this patent, the two types of applicators, namely an electrical conductor or an electromechanical vibratory transducer.
• - Said physiological signal is detected by a second series of skin electrodes different from a first series of electrodes for the application of said pulse sequences.
• - Said physiological signal is detected by the series of skin electrodes used for the application of said pulse sequence, the method comprising a step for extracting from the measurement signal the information correlated to said pulse sequence.
• the triggering and the maintenance of a pulse sequence is controlled by the detection of a muscular activity in response to an action of the patient, in the absence of stimulation, by skin electrodes detecting an electromyographic surface signal, the frequency of the pulses being between 0.5 Hz and 200 Hz.
• the process controls the recording of muscle activity simultaneously with the passage of stimulation.
• said detection of muscle activity corresponds to the contraction of a first muscle group and in that said pulse sequence is applied to a second muscle group.
• said detection of a muscle activity corresponds to the contraction of a first muscle group and in that said sequence of pulses and recording of muscle activity is applied to a second muscle group. it includes a step of triggering a sequence of pulses controlled by the detection of involuntary muscle activity in the absence of stimulation and in the absence of patient action, by skin electrodes detecting an electromyographic surface signal , the pulse frequency being less than 10 Hz.
• the energy of the pulses is a function of the characteristics of the electromyographic signals detected.
• the electrical pulses are regulated in voltage and in current as a function of the characteristics of the electromyographic signals detected.
• the invention also relates to a muscle stimulation system for implementing the method according to the above invention, characterized in that it comprises at least one stimulation electrode and two detection electrodes and a computer controlling the generation of a pulse stimulation sequence with a frequency between 0.5 Hz and 200 Hz, after the detection of muscle activity in the absence of stimulation.
• the system also includes a multidirectional inertial sensor secured to a skin electrode. - It has a plurality of outputs delivering the same EMG signal, for the connection of a plurality of electrodes to simultaneously re-educate several muscle groups.
• Radio frequency communication means for the transmission of stimulation information and of detection of physiological signals to remote equipment.
• It includes means for transcutaneous vibration stimulation from 30 to 100 Hz.
• FIG. 1 shows a schematic view of a system for implementing the invention
• FIG. 2 shows a view of the block diagram of a generator for equipment according to the invention.
• the invention relates generally to a method and a system for muscle or nerve stimulation by the application, via skin electrodes, of sequences of electrical pulses.
• ESM muscle electrostimulation
• Muscle electrostimulation sends external electrical impulses which act on the across the skin. In both cases, the muscle reacts and contracts.
• the invention also applies to electrostimulation of the vagus nerve.
• the muscle or nervous group to be treated can be determined selectively by the application of skin electrodes.
• the invention relates more particularly to the use of electrostimulation for rehabilitation, for the recovery of full control of muscle control.
• the invention consists in detecting not such a sound indirectly correlated to the will of the patient, but a physiological signal by one or more skin bioelectric sensors.
• These signals include:
• EMG Electromyogram
• the invention consists in positioning skin sensors on the patient allowing the detection of signals selected physiological parameters, to process the detected electrical signal and to command the triggering of a sequence of pulses as a function of the result of this processing, for example by exceeding a threshold.
• the sequence of electro-stimulation signals has a pulse frequency between 0.5 Hz and 200 Hz.
• the physiological signal is an ECG signal
• the electrical level is of the order of a millivolt.
• Signal processing includes amplification, filtering and sampling, for example at a sampling frequency between 5 and 15 kHz.
• Digital filtering eliminates high frequency signals secondary to muscle activity other than cardiac and interference from electrical devices.
• a low frequency filter makes it possible to reduce the undulations of the baseline secondary to respiration.
• the electrodes which collect the signal are placed directly on the skin facing the muscle to be studied. This detection consists in recording the electrical activity of muscles and nerves.
• Figure 1 illustrates the use of a stimulation system for the implementation of the invention.
• It comprises an electronic box (1) comprising an electronic circuit for measuring and controlling the electrical pulses applied by means of electrodes, as well as a set of electrodes.
• These electrodes include:
• a patch (2) having on its surface two measuring electrodes (3, 4). These electrodes are connected to the EMG signal measurement input, and are placed on the patient's expiratory muscle area
• the electronic unit (1) also communicates with connected computer equipment, for example a computer (10), a tablet (11) or a cellular telephone (12) to receive the information acquired and processed by the unit (1) and for transmit adjustment parameters.
• connected computer equipment for example a computer (10), a tablet (11) or a cellular telephone (12) to receive the information acquired and processed by the unit (1) and for transmit adjustment parameters.
• the sensors intended for the acquisition of physiological signals of muscular biological feedback are according to the chosen variants:
• Cutaneous electric electrodes physically separate from the electrical stimulation electrodes, for example conductive tablets placed on a support capable of being applied against the skin and maintained by a biocompatible adhesive, a strip; or textiles
• One or more dual-function electrodes used alternately for signal pickup
• the electronic circuit comprises a chopper with two electronic switches making it possible to connect the common electrode alternately to the input and to the output of the circuit.
• a balloon equipped with a pressure sensor delivering a signal depending on the effort exerted by a muscle.
• Electrical stimulation via conductive electrodes applied to the patient's skin in the vicinity of the muscle to be rehabilitated can be replaced by
• It can also be applied by a pulsed magnetic field, applied in the vicinity of the muscle to be rehabilitated.
• the electric electrodes are then replaced by a device for local magnetic stimulation, comprising at least two magnetic coils, which are
• Functional electrostimulation in which a muscle or nerve is electrically stimulated via contact electrodes in order to effect a muscle contraction in order to support or replace certain physiological processes.
• Functional magnetic stimulation causes muscle contraction, triggered without contact by appropriate magnetic fields.
• the application device for pelvic muscles can take the form of a chair, the seat of which incorporates the magnetic coils.
• Figure 2 shows a schematic view of the electronic circuit.
• This circuit (21) receives as input the measurement of the transcutaneous resistance measured by the measurement electrodes (3, 4) and produces a control voltage V totai such that:
• I stim designates the stimulation current level set by the practitioner.
• This voltage supplies a circuit composed of 4 electronic switches, in particular of 4 thyristors (22 to 25) which makes it possible to control the passage of the stimulation voltage either in one direction, when the switches (23 and 25) are closed, or in the opposite direction when the switches (22 and 24) are closed.
• This thyristor bridge is connected to a load shedding circuit (26) controlling the voltage V diest so that
• V st ⁇ designates the level of voltage absorbed by the patient through the electrodes with regard to the current which is set by the practitioner.
• This load shedding circuit (26) is connected to a current controller (28) via a fuse (27).
• This current controller (28) controls a slope of current with respect to the setpoint, for a time evolution with a first period of increase in current, then of hold at a current plateau, then decrease the current to 0.
• a power module converts the electrical stimulation signals into pulsed electrical signals supplying the magnetic coils.
• the intensity of the physiological biological feedback signal is recorded with
• the difference in intensity between the physiological biological feedback signal and the stimulation signal is recorded, to calculate a profile representative of the degree of rehabilitation.
• These indicators are used to control a visual indicator, for example a series of LEDs activated according to the level of the difference signal, or a graphic indicator.

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• 2018
  • 2018-06-29 FR FR1856032A patent/FR3083123A1/fr active Pending
• 2019
  • 2019-06-21 WO PCT/FR2019/051522 patent/WO2020002801A1/fr active Application Filing
  • 2019-06-21 MA MA053016A patent/MA53016A/fr unknown
  • 2019-06-21 EP EP19745702.1A patent/EP3813924A1/de active Pending

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