[go: up one dir, main page]

WO2025219481A1 - Systèmes et procédés de stimulation électrique de tissus nerveux, musculaires et corporels - Google Patents

Systèmes et procédés de stimulation électrique de tissus nerveux, musculaires et corporels

Info

Publication number
WO2025219481A1
WO2025219481A1 PCT/EP2025/060568 EP2025060568W WO2025219481A1 WO 2025219481 A1 WO2025219481 A1 WO 2025219481A1 EP 2025060568 W EP2025060568 W EP 2025060568W WO 2025219481 A1 WO2025219481 A1 WO 2025219481A1
Authority
WO
WIPO (PCT)
Prior art keywords
subject
stimulation
stimulation signals
output
signals
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2025/060568
Other languages
English (en)
Inventor
Roberto Ciaff
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of WO2025219481A1 publication Critical patent/WO2025219481A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61N1/02—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
    • 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
    • A61N1/36014—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
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0004—Applications of ultrasound therapy
    • A61N2007/0021—Neural system treatment
    • A61N2007/0026—Stimulation of nerve tissue

Definitions

  • the present invention relates to the field of medical devices, in particular electrical therapy devices for stimulation and/or activation of body nerve, muscle or other body tissues.
  • Electrical stimulation is a non-invasive and non-pharmacological physical stimulus and has a wide range of direct effects on biomolecules and cells. These effects have been used in clinics, for example, for pain mitigation, muscle rehabilitation, wound healing and drug delivery.
  • electrode pads are often placed on the skin at the target location to deliver electrical stimulation.
  • electrical stimulation refers hereinafter to the physiological stimulation of cellular and tissue activities through the application of electrical field or current.
  • NMES neuromuscular electrical stimulation
  • an electrode pad is positioned over the muscle to be treated and an electrical current is discharged by a generator.
  • the current reaches a desired level, it is delivered, by means of a drive signal, to the electrode pad and into the muscle tissue.
  • the sudden arrival of this current in the tissue causes depolarization of the sensory nerves directly under the electrode triggering localized muscle stimulation.
  • the electrode is then actively driven to a low potential creating a low resistance path, which encourages the current already delivered to the underlying tissue to return to the generator.
  • the current travels through a continuous closed circuit comprising the current generator, the electrode, the electrical wiring between the electrode and stimulator and the tissue immediately beneath the electrode.
  • EMS electrical muscle stimulation
  • Hz frequency
  • mA amplitude
  • ms pulse width
  • Some devices have pre-set programmes with pre-set parameters and session times. Some devices will provide one set level of frequency and pulse width, others will provide the option to adjust the frequency/pulse width within a pre- set range. Amplitude may not always be set at the same level at each treatment session and is therefore always adjustable. The clinician is required to be confident in the manipulation of these parameters to use EMS effectively.
  • DWS Digital waveform shaping
  • TESS transcutaneous electrical nerve stimulation
  • EMS electric muscle stimulation
  • FES functional electrical stimulation
  • IFC interferential current
  • Russian stimulation transcranial focused ultrasound (tFUS)
  • tUS transcranial unfocused ultrasound
  • tUS transcranial unfocused ultrasound
  • the present invention is a system for the stimulation of a body part of a subject, comprising: a charge generator configured to output one or more treatment stimulation signals, wherein the stimulation signals comprise electrical stimulation signals; one or more electrodes for contact with the body part of the subject for delivering the stimulation signals to the body part; a sensor configured to sense at least one physical characteristic of the subject; a processor configured to determine stimulation parameters of the stimulation signals to be output by the charge generator to elicit the required treatment response; and a controller in communication with the sensor configured to control the output/delivery of the stimulation signals, and to temporarily cease delivery of the stimulation signals to the body part when at least one physical characteristics of the subject has reached a threshold value; wherein the charge generator is configured to output a variable stimulation signal for delivery to the body part.
  • the system is configured to output an electrical stimulation signal that has at least one variable parameter selected from: amplitude (peak voltage), pulse width, pulse repetition/rate frequency, a current, a pulse shape, and a pulse polarity.
  • the system of the present invention is configured to output a variable waveform in which at least one parameter of the waveform, such as pulse width, changes over the whole or at least a portion of the time of the stimulation of the body part.
  • at least one parameter of the electrical stimulation signal output from the generator is variable, i.e. changes or is not-fixed, preferably for the duration of the treatment stimulation of the body part.
  • the electrical stimulation signal is a pulsed output waveform that may have the following four basic parameters: amplitude (A), pulse width (Pw), impulses per second (IMPs) or pulse repetition frequency (Prf) and polarity (positive or negative).
  • the waveform may be a basic shape such as sine, triangle, square, or saw-tooth, or a complex shape comprising a combination thereof.
  • a complex shape waveform may have various sections of different forms, such as a curved rising edge, a triangle middle section, a straight falling edge. The skilled person will be familiar with the various possible waveforms that may be generated by the pulse generator.
  • the system further comprises a source for providing sound signals to the body part.
  • a source for providing sound signals to the body part In this way, combined sound and electrical stimulation is provided by means of the system.
  • sound stimulation signals are provided to the body part simultaneously with, separately from, or alternating with, the electrical signals.
  • the sound stimulation signals are output by the same charge generator as the electrical signals.
  • the sound stimulation signals are output from a separate source to the charge generator for the electrical signals.
  • the sound signals are ultrasound signals.
  • the ultrasound source may operate in a frequency range of 2 to 18 Mhz, such as from about 1 to about 4 MHz.
  • the source may be an ultrasound transducer that is arranged to transmit acoustic energy from the surface of the skin through superficial tissues to deeper regions of tissue.
  • the charge generator is arranged to output the sound signals.
  • the source for the sound signals may be operated by the controller.
  • the physical characteristic of the subject is selected from one or more of: skin resistance, tissue or cell action potential response, a motion, body temperature, pulse rate, respiration rate, blood pressure, and oxygen saturation of blood.
  • Skin resistance for a subject, in particular a mammal, e.g., human subject may vary from about 1000 to about 100,000 ohms depending on moisture, condition of the skin, and other factors.
  • Electrical energy generally breaks down human skin, reducing resistance from about 55 ohms to about 500 ohms.
  • a threshold for skin resistance may be less than about 55 ohms and/or greater than about 500 ohms.
  • a muscle action potential response may vary from about -90mV to about 40 mV, such as from about -80mV or about -70 mV to about 30 or 35 mV.
  • the controller is arranged in the system to cease output /delivery of the stimulation signals to the subject upon sensing a motion of the body part, body temperature, pulse rate, respiration rate, blood pressure, and/or oxygen saturation of blood that has reached a threshold value that is above an acceptable maximum value or below an acceptable minimum value.
  • a motion may take the form of an extension or flexion and might trigger the control means to cease output and/or delivery of the stimulation signals when the motion is about 15 or about 10 mm, such as from about 5 mm to about 20 mm or greater.
  • the skilled person would be aware as to physical characteristics that are considered to be vital signs and the normal values thereof.
  • the four main vital signs include body temperature, pulse rate, respiration (breathing) rate, and blood pressure.
  • a body temperature that might trigger the controller to cease output and/or delivery of the stimulation signals may be less than about 36 °C and more than about 37 °C, such as about 32.5 °C or about 38 °C.
  • a pulse rate (heart rate) that might trigger the controller to cease output and/or delivery of the stimulation signals may be a resting pulse rate of less than about 40 and/or greater than about 120, or less than about 50 or 60 and/or greater than about 130.
  • a respiration rate (breathing rate) that might trigger the controller to cease output and/or delivery of the stimulation signals may be less than about 12 breaths per minute or more than about 20 breaths per minute.
  • a blood pressure that might trigger the controller to cease output and/or delivery of the stimulation signals may be a systolic of about 120 to about 129 and diastolic of less than about 80; or a systolic of about 130 to about 139 or a diastolic of between about 80 to about 89; or a systolic of about 140 or higher or a diastolic of about 90 or higher, such as 180/120 mmHg.
  • An oxygen saturation of blood that might trigger the controller to cease output and/or delivery of the stimulation signals may be less than about 95% or less than about 91%.
  • the frequency content of the individual pulses is about 10 kH or lower.
  • the pulse repetition rates are between about 30 Hz or greater, such as up to about 100 Hz or about 50 Hz.
  • the energy is delivered with an alternating series of on (during which pulses are applied at a given repetition rate) and off times (during which no pulses are applied).
  • the on times last for about 5 seconds to about 10 seconds.
  • the off times last for about 10 seconds to about 20 seconds.
  • the sensor is integral with the one or more electrodes. In an alternative embodiment, the sensor is a separate component.
  • the controller is configured to cease delivery of the electrical stimulation signal in response to a muscle contraction.
  • the parameters of the electrical stimulation signals output are determined according to the skin resistance value and/or action potential response value of the subject.
  • the present invention provides a system as described for the stimulation of a body part of a subject for use in therapy.
  • the system may be used for the treatment and/or diagnosis of neuromuscular and tissue disorders, to alleviate pain and/or to provide injury rehabilitation.
  • the present invention provides a wearable item, including a system for the stimulation of a body part of a subject as described.
  • the wearable item may be a soft, stretchable material.
  • the wearable item may be an item of clothing such as a sports undergarment or Lycra suit, or in the form of a wrist band or the like.
  • the present invention provides a mat, such as a yoga mat, including a system for the stimulation of a body part of a subject as described.
  • the yoga mat can be a combination of a “dry” or “wet” application, the user can immerse the yoga mat into a bath tub, hot tub, shower unit or spa.
  • the system for the combined ultrasound and electrical stimulation of a body part of a subject according to the present invention further comprises a visual display unit configured to provide real-time images of the body part response during body part stimulation, activation and in rest mode from the ultrasound signals.
  • the charge generator and the processor are provided as an integral unit.
  • the present invention provides a toroid charge generator adapted to output one or more electrical stimulation signals, wherein the toroid charge generator further comprises integral processing means configured to determine stimulation parameters of the stimulation signals to be output by the charge generator to elicit a required treatment response suitable for stimulating a body part of a subject for therapeutic treatment.
  • the processing means determines the stimulation parameters for the signals using a suitable algorithm.
  • the present invention is a method for the stimulation of a body part of a subject, comprising: contacting the body part of the subject with one or more electrodes; providing a charge generator to output one or more stimulation signals to the one or more electrodes; causing stimulation signals from the charge generator to be delivered from the one or more electrodes to the body part; providing a sensor to sense at least one physical characteristic of the subject; providing a processor to determine stimulation parameters of the stimulation signals to be output by the pulse generator; providing a controller to control output of the stimulation signals from the charge generator to the body part in response to feedback received from the sensor, and temporarily ceasing output/delivery of stimulation signals when a physical characteristic of the subject has reached a threshold value; and delivering a stimulation signal, wherein the stimulation signal is variable during the stimulation treatment.
  • the method further comprises providing sound signals, preferably ultrasound signals, to the body part.
  • the method comprises delivering a stimulation signal having at least one parameter that varies or changes.
  • the method comprises delivering electrical stimulation signals sufficient to cause an action potential in the stimulated muscle, and the method optionally further comprises measuring the muscle contraction response.
  • the ultrasound signals after cessation of delivery of the electrical signals to a body tissue, the ultrasound signals are output to surrounding body tissue and the method further comprises monitoring the ultrasound signals output or dissipated to the surrounding tissue.
  • Embodiments of the present invention may differ with regard to the number of electrodes that are used, the distance between electrodes.
  • the present invention provides an adaptive electrical stimulation to provide an electrical stimulation signal having desired parameters delivered to target tissues.
  • dynamic effects such as a change in impedance at circuit/tissue interface during electrical stimulation application are considered.
  • the present invention additionally allows real-time electrical stimulation monitoring at the target tissue during electrical stimulation. This will assist to ensure that the desired intensity is delivered and the outcome is reproducible.
  • the present invention provides a delivery method analogue waveform shaping (AWS) function that is different from the known devices.
  • AWS analogue waveform shaping
  • the system provides variable electrical charge frequencies combined with variable charge sound packets, which allows increased penetration of electrical stimulation to deeper neural and muscle tissue. Further, the system allows for the recording of tissue response in real- time.
  • the system of the present invention also provides a non-invasive full body peripheral nervous evaluation test, with enhanced patient comfort, and deep pain relief and injury rehabilitation.
  • the system of the present invention provides a true motor neuron and deep-seated muscle activation application without the need for invasive probes and needles.
  • the system of the present invention also allows for narcotic pain medication to be reduced and helps to speed up patient recovery time.
  • the present invention removes the typical “pins and needles” etc. effect, as well as the discomfort and burning sensation, found using other methods of electro stimulation therapy devices.
  • the system and the method of the present invention are also unique as they allow real time recording of ultrasound video and images of body tissue while activated or in rest mode.
  • the system and method of the present invention allow for deep-rooted motor neuron muscle activation verses topical stimulation.
  • the electrical signal output is such that it can bypass the sensory nerves and initiate muscle contraction and re-education without the pain and discomfort felt using traditional methods.
  • the combined ultrasound and electrical signal can deliver “variable charged packets”. The signal generated by these variable charged packets replicates brainwave and neuro-muscular signals.
  • variable sound waves protect the electrical charge and allow the electrical signal to safely enter the body to reach and activate deep rooted nerves and muscles.
  • the sound carries the variable signal throughout the body and when it finds decompressed nerves, it releases the charge at the synapse nerve causing it to release acetylcholine, thus causing muscle activation and repair.
  • the nerve that controls the muscle the muscle contracts and the natural organ combustions react for the myofascial release to occur.
  • This fascial internal softening allows the blood to lubricate and feed body minerals to the underlining areas of tissue.
  • the present invention can be used on humans and other mammals, such as canines and horses, to treat a plethora of injury profiles.
  • Various therapeutic conditions such as pain, oedema, stiffness, immobility, decreased Range-of-Motion (ROM), nerve pain, muscle atrophy, poor circulation, poor gait
  • ROM Range-of-Motion
  • the present invention is also of benefit to healthy individuals, for example professional and amateur athletes, in terms of increased performance, recovery time, as well as in pre- and post-surgical rehabilitation.
  • the present invention provides a non-invasive, pain free way to deeply activate muscle tissue, increase circulation, reduce oedema, improve muscle atrophy, increase ROM, decrease pain, improve adhesions, fascial stickiness and network, address tendon issues, speed up recovery, improve oedema, circulation and recovery after post-surgical treatment.
  • the charge generator used in the system and method of the present invention is toroid-shaped and has processing means that may comprise microchips, capacitors, inductors, and/or resistors embedded in the toroid, which may consist of primary and secondary toroids.
  • processing means may comprise microchips, capacitors, inductors, and/or resistors embedded in the toroid, which may consist of primary and secondary toroids.
  • low level electrical signals are output from the charge generator to the subject to be treated.
  • a neuron or nerve sends a signal, which is a chemical signal involving ions moving in and out of the neuron, it does so via an action potential.
  • the processor or microchip in the charge generator is configured to calculate the subject’s action potential response and/or skin resistance by use of an algorithm and then causes the generator to deliver pulses with the calculated variable frequencies, variable polarity mode, variable amplitude, variable pulse width’s and/or variable decay rate speeds, sufficient to cause activation of the motor neuron groups.
  • the present invention uses high-frequency sound waves to view inside the body. Because ultrasound images are captured in real-time, they can show movement of the subject’s internal organs as well as blood flowing through the blood vessels. Unlike X-ray imaging, there is no ionizing radiation exposure associated with ultrasound imaging. In an ultrasound exam, a transducer (probe) is placed directly on the skin or inside a body opening.
  • a thin layer of gel is applied to the skin so that the ultrasound waves are transmitted from the transducer through the gel into the body. While the transducer is placed directly on the skin and the ultrasound waves are transmitted from the transducer, the same transducer may simultaneously deliver charge packets from the charge generator to activate the nerves for neuromuscular or organ activity.
  • a control unit controls output of the stimulation signals from the generator and hence controls delivery of the stimulation signals to the electrode, which in turn delivers electrical energy into the body.
  • the control unit can be positioned a distance from the subject receiving the therapy on whom the electrodes are positioned.
  • the stimulation electrodes are housed in a custom stimulation pad such that the electrode layout and configuration is optimized for a particular region of the body.
  • Action potentials are generated by special types of voltage-gated ion channels embedded in a cell's plasma membrane. These channels are shut when the membrane potential is near the (negative) resting potential of the cell. These channels rapidly begin to open if the membrane potential increases to a precisely defined threshold voltage (-55mV), depolarising the transmembrane potential. When the channels open, they allow an inward flow of sodium ions, which changes the electrochemical gradient, which in turn produces a further rise in the membrane potential towards zero. This then causes more channels to open, producing a greater electric current across the cell membrane and so on. The process proceeds explosively until all the available ion channels are open, resulting in a large upswing in the membrane potential.
  • a precisely defined threshold voltage -55mV
  • the feedback measurements received by the processor in the charge generator of the skin’s resistance and action potential response in the subject’s cells may be used to calculate the variable pulses to be output to the subject.
  • the measurements include measurements of tissue vitals.
  • the pulses output may have variable frequencies, variable polarity modes, variable polarity amplitudes, variable gated charges or pulse widths with variable decay rates.
  • Charge generator The preferred embodiment of the charge generator is a stimulator toroidal coil.
  • the coil may comprise a toroidal winding around a core consisting of a high permeability material (e.g., Supermendur), embedded in an electrically conducting medium. Different diameter toroidal cores and windings may be preferred for different applications.
  • the outer diameter of the coil may be typically 1-5cm, with an inner diameter typically 0.5-0.75 of the outer diameter.
  • the coil’s winding around the core may be typically 3 to 250 in number, depending on the core diameter and depending on the desired coil inductance.
  • the electrical or magnetic generator is configured to induce peak pulse voltage sufficient to produce an electric field in the vicinity of a nerve to cause the nerve to depolarize and reach a threshold for action potential propagation.
  • the threshold electric field for stimulation of the nerve may be about 8V/m at 1000 Hz.
  • Waveforms The magnitude and type of response elicited by electrical stimulation is dependent on the amplitude, frequency and pulse width of the stimulus waveform.
  • the stimulation parameters are controllable in real time.
  • the processor is programmed with firmware that defines stimulation and allows real time adjustments of the stimulation parameters.
  • a suitable waveform e.g., a full sinusoidal
  • suitable parameters such as current, voltage, pulse width, pulses per burst or packet, inter-packet interval, etc.
  • the system and method of the present invention cause a correspondingly selective physiological response in an individual patient.
  • a charged output waveform such as that produced by the microchipped toroid charge generator illustrated in Figure 2 has four parameters. Three apply to the output pulses and one applies to the overall waveform.
  • charge packets output are pulsed at a variable rate from around 1,000 per second to about 50,000 per second.
  • the rate of stimulation pulses output may vary x times per second (dependent on real-time feedback), where x may be any number above 2, such as a million.
  • the pulse rate is variable and not fixed.
  • the duration (width) of the pulses may vary and is not fixed, the duration of each pulse is in the range of about 5 to about 350 microseconds.
  • Each charge pulse may have a variable peak output voltage of about 0.1mV to about 150 V.
  • the electrical variable polarity (i.e. positive or negative) and/or the variable electrical potential i.e.
  • the MTCG effects delivery of pulses (packets) to the tissue in quick and variable succession, each sequential charge preferably repelling the preceding charges and causing penetration of the charge packets deeper into the tissue.
  • a desired level sufficient to activate the tissue (for example, to cause an action potential to activate a contraction in muscles for the production of the chemical acetylcholine)
  • the circuit between the charge generator and the tissue is broken. Data is collected and feedback to the system is provided.
  • the breaking of the circuit by the charged generator, causing the cessation (e.g. a temporary cessation) of the delivery of the charge packets to the subject may be triggered in any of a variety of ways.
  • the system includes sensors to sense a physical characteristic of the subject.
  • the sensors comprise part of the output mechanism and may, for example, be part of the electrode.
  • the physical characteristic of the tissue that is sensed by the sensor and fed back to the generator will include the body temperature and/or humidity of the skin.
  • the sensor may sense the physical characteristic of a motion, for example a vibration and/or a contraction of a muscle of the subject, and the system will calculate the charged energy needed to be delivered into the tissue.
  • the pulse rate of the electrical charge pulses supplied to the electrode by the charge generator is determined, at least in part, by the physical characteristic sensed by the sensor. The pulse rate is controlled such that the rate of a substantially continuous stream (or "train") of pulses is varied.
  • the pulse rate is controlled such that a substantially continuous stream of pulses is broken by intermittent absences of one or more pulses from the stream for feedback that is returned to the microchipped charge generator. (This may be referred to as "packet skipping").
  • the electrical pulses charge packets
  • the electrical pulses are delivered in discrete trains (or streams) of the pulses, separated in time by absences of the trains of pulses. The absences may be a matter of one or more seconds, or one or more minutes, for example.
  • the pulses are determined and supplied in this way by the electrical charge generator/processor, to the electrode or electrodes.
  • the system of the present invention may be arranged such that when a sensor of the system detects a first predetermined value of a physical characteristic, the supply of electrical charge pulses to the electrode by the charge generator is stopped.
  • This "first predetermined value” preferably is a maximum value, for example a maximum skin ohms resistance measurement and skin temperature (e.g. 40 degrees Celsius), a maximum electrical potential (voltage) and/or a maximum movement or rate of movement (e.g. a muscle contraction or spasm).
  • the supply of electrical charge pulses may be resumed when the sensor detects a second predetermined value of the physical characteristic.
  • the "second predetermined value" is a lower value than the first predetermined value, e.g. a lower temperature, a lower electrical potential, and/or a smaller (or complete absence of) movement.
  • the use of the system and method of the present invention results in a high degree of lateral migration of charge from the area immediately underlying an electrode, permitting the activation of tissue areas significantly larger than the area of the electrode.
  • deeper tissue penetration can be achieved using this apparatus and method.
  • Such a longer-range migration of charge through the tissue ensures better, wider, and distance-ranging activation of the deeper-seated motor nerves as opposed to the sensory nerves located nearer the skin surface.
  • the ability to activate a larger area and depth of tissue through which charge is delivered enables a neurotherapy practitioner more easily to locate dysfunctional tissue within, for example, a muscle group by introducing charge into the centre of the group and observing the action potential contractions in the surrounding tissues. Once the dysfunctional tissue has been located, and any other treatments can be targeted specifically at the dysfunctional muscle within the group.
  • a further advantage of the use of the system and method of the present invention is that variable smaller or larger electrical charges can be used to achieve the desired tissue activity. This renders the system safer to use for the practitioner and the patient, and results in reduced patient discomfort.
  • the system may include a single probe or electrode, or more than one electrode.
  • the apparatus includes two electrodes, but in some versions more than two but not more than five electrodes may be used.
  • one or more electrodes are coupled together in a single housing, or pad (patch).
  • Custom stimulation pads may have surface electrodes placed in a predetermined configuration on the pad. Any number of electrodes can be included in the stimulation pad.
  • the stimulation pad may be comprised of a thin and flexible housing with an adhesive hydrogel backing to facilitate maintenance of skin contact. The hydrogel backing will also enhance the coupling of electrical energy and signals between stimulation electrodes and the subject’s body.
  • the control unit includes a user interface to allow medical personnel to control the parameters of electrical energy delivery to the patient.
  • the control unit can be adapted to allow a user to manually set parameters of electrical stimulation or it can be adapted to allow a user to adjust the parameters of electrical stimulation at any point during or after the therapy.
  • the user interface can be housed in the control unit, or it can be a separate device similar to a remote control that is in communication with the control unit.
  • the user interface can include buttons, knobs, dials, switches, etc., to control the parameters of energy delivery.
  • the control unit is configured to automatically adjust stimulation parameters based on optimization software in the control unit.
  • the control unit is configured to receive sensed patient signals that are generally sensed using one or more sensors positioned on or within the patient. One or more sensors can be used to sense parameters from the patient and provide feedback to the control unit.
  • the sensor can include a temperature sensor configured to monitor the temperature on the skin of the patient.
  • the control unit can be configured to continuously or periodically receive the sensed temperature and a control algorithm can compare the sensed temperature with a reference temperature to determine if the sensed temperature is higher or lower than the reference temperature. Based on the comparison, the therapy may require that the pulses are stopped, or adjusted.
  • Monitoring the skin temperature can provide an indication of the temperature gradient created in the tissue and therefore provide an indication if the gradient is sufficient to deliver a sufficient percentage of energy entering the patient to deep-lying muscle tissue.
  • temperature is an exemplary subject physical characteristic that can be sensed and fed back to the processor to determine the parameters of the variable pulses to be delivered.
  • the sensor can sense the degree of muscle stimulation or contraction. Sensing muscle contraction can be performed with, for example, an EMG.
  • a control unit may be in electrical communication with the electrode and sensor.
  • the control unit can be adapted to receive the sensed subject characteristic indicative of muscle contraction and feedback this information to the processor to determine the variable electrical stimulation. For example, if the sensed characteristic indicative of muscle contraction indicates an insufficient amount of contraction, it may be desirable to increase one or more parameters of the electrical stimulation.
  • the response to the sensed characteristic can be automatically controlled by the control unit.
  • one or more sensors are coupled to the person receiving the therapy and are adapted to record data indicative of a physical characteristic, such as muscle contraction, and feedback control systems within the control unit are used for closed loop optimization of stimulation energy.
  • the control unit and/or the processor can also include one or more memory units to store, for example without limitation, algorithms used to carry out the functionality of the stimulation therapy, therapy protocols, sensed patient characteristics, and/or stimulation parameters.
  • the memory units can be in any of the following forms: RAM, ROM, EEPROM, volatile memory, non-volatile memory, or any combination thereof.
  • the memory units can be in communication with a processor to carry out the stimulation therapy.
  • the system may use relatively low frequency ultrasound energy (about 1-4MHz) to reach a depth appropriate for the muscle group being stimulated.
  • the system may be used in "dry” or “wet” modes, that is, the electrode(s) may be applied directly to the human or animal subject (with or without an intervening medium, e.g. a gel), or the electrode(s) may be immersed in water in which part or all of the subject is also immersed.
  • the system includes the ability to deliver acoustic (sound wave) to the subject, together with, or separately from, the delivery of electrical charge activation. This may be carried out when the system is used in its "wet” mode, i.e. with the electrode(s) and all or part of the human or animal subject immersed in water.
  • the acoustic activation is provided by the injection of pulsing jets of air (or by another means) into the water.
  • the additional unique functionality of the generator of the present invention is a simultaneous delivery of a series of variable polarity and variable sound wave packets that wraps the charge (pulses) mechanism of events into the tissue. These sound waves may delivered simultaneously with the charged packets while in “dry” or “wet” applications.
  • variable or “varied” in relation to a stimulator signal means that the stimulation signal changes, i.e. it is not fixed.
  • An electrical stimulation signal is a pulsed output waveform that has parameters of amplitude, pulse width, impulses per second, wave shape, pulse polarity and one or more of these parameters is varied, within acceptable minimum and maximum ranges for a subject, over a period of time.
  • a delivered variable pulse can have at least one parameter that changes multiple times over a period of time.
  • the terms “about” and “approximately” mean plus or minus 20%, more preferably plus or minus 10%, even more preferably plus or minus 5%, most preferably plus or minus 2%.
  • the terms “comprises” and “comprising” are interpreted to mean “includes, among other things”. These terms are not intended to be construed as “consists of only”.
  • Figure 1 is a block diagram of a system for the stimulation of a body part in accordance with an embodiment of the present invention
  • Figure 2 is an example of a charge generator for use in the system for the stimulation of a body part of the present invention
  • Figure 3 is an example application of the system for the stimulation of a body part of the present invention
  • Figure 4 is an example of a combined ultrasound and electrical stimulation component for use in the system for the stimulation of a body part in accordance with the present invention
  • Figure 5 is an example of a control unit for use in the system for the stimulation of a body part in accordance with the present invention
  • Figure 6 shows examples of (a) variable sound and electrical waves, and (b) cumulative sound and electrical waves, generated by the charge generator of the system for the stimulation of a body part in accordance with the present invention
  • Figure 7 (a), (b), (c), (d), e), (f), (g), (h) and (i) show examples of pulsed output waveforms generated by the charge generator of the system for the
  • the present invention provides systems and methods of improving electrical stimulation therapy by providing a more efficient transfer of electrical energy to tissue, and in particular to deep tissue.
  • the present invention relates to electrical muscle stimulation with an ultrasound guidance field that drives electrical energy towards muscle tissue, and in particular towards deep-lying muscle tissue.
  • Figure 2 shows a microchipped toroid charge generator (10).
  • a coil of wire (12) is wound around a toroidal core (14), consisting of high permeability material. Current passes through the coil and the coil is connected to the pulse generator by a lead wire.
  • a processor in the form of a microchip (16) is embedded in the centre of the toroidal core.
  • Figure 4 shows an ultrasound transducer (30) that may be connected by an electrical wire (32) to an electrode.
  • the transducer has a rotary array underneath a protective cover (34) and a control button (36).
  • Figure 5 shows a controller that has a visual display (40) for images and data, a control orbit trackball (42) and two output balance controls (44, 46).
  • the controller may be connected by electrical wires (48) to the generator.
  • Methods of using the systems described herein may include one or more of the following steps. At least one electrode is placed on the surface of the skin in the vicinity of a muscle to be stimulated. At least one sensor is placed on the surface of the skin.
  • variable pulses are generated by the pulse generator and delivered by the electrode to the area of skin underneath the electrode, together with ultrasound signals from an ultrasound transducer.
  • Image data associated with motion is captured and stored to memory or displayed in real time on a visual display unit.
  • the subject may receive stimulation signals to a body part that is immersed in water or may receive stimulation signals from the system while seated or lying on a yoga mat.
  • Figure 3 shows a bath (18) in which a mat (20) including the system is provided.
  • the mat (20) includes a plurality of friction pads (22) and includes the electronics of the system of the present invention in a housing (24) at one end, and the mat includes a charging port (26).
  • Muscle stimulation may be provided as a pulsed train composed of a series of asymmetric, biphasic square waves with variable pulse durations of 100-400 microseconds and variable repetition rates of 40 to 300 Hz. Pulse trains lasted for 5 seconds with 1 second energy ramp up and ramp down time (i.e., 3 second of maximum energy delivery) and were followed by resting periods of at least 10 seconds.
  • the variable current delivered by the electrode to the subject ranged from about 30 to about 80 mA. Peak voltage was variable between 0.1 mV to 150 mV.
  • a pulsed output waveform such as that produced by the method described herein has four basic parameters, as indicated below (waveform basics).
  • the systems and methods of the present invention allow for the control of these four basic parameters for the output of pulses on one, two or more channels.
  • each waveform consists of two pulses, the Primary Pulse (PP) and the Secondary Pulse (SP), which are of opposite polarities and join at the crossover point.
  • PP Primary Pulse
  • SP Secondary Pulse
  • ‘Rising’ is defined as increasing any given variable polarity, and not restricted to an increasing positive potential
  • variable ‘Falling’ is defined as decreasing any given polarity, and not restricted to a decreasing positive potential.
  • the rising edge of PP is referred to as the Primary Rising Edge (PRe) and the falling edge is referred to as the Primary Falling Edge (PFe).
  • the rising edge of SP is referred to as the Secondary Rising Edge (SRe) and the falling edge is referred to as the Secondary Falling Edge (SFe).
  • the duration of the Primary and Secondary pulses is referred to as the Primary Pulse Width (PPw) and Secondary Pulse Width (SPw) respectively, these combine to form the variable Waveform Duration (Wd). It should be noted that in the case of shaped pulses where Re and Fe are not near instantaneous the Pw is taken between the half power (-3dB) points of the Re and Fe.
  • Ct The time between successive waveforms, or variable waveform sequences (detailed later), is referred to as the variable Cycle Time (Ct).
  • the inverse of Ct is referred to as the Waveform Repetition Frequency (WRf).
  • INTENSITY The perceived ‘intensity’ experienced by the recipient of a variable waveform is not purely a function of amplitude but is in fact a function of a variable waveform power (W).
  • Figure 7(a) shows the power contained in a square wave pulse. Power is a function of the area covered by a waveform, therefore amplitude, Pw and shape all effect the perceived ‘intensity’.
  • the system does not have a single ‘Intensity’ control but instead provides linear control of several functions which effect W.
  • Basic Pulse Shaping Functions that are provided for edge shaping are None (Square), Linear (LIN), Sine (SIN) and Exponential (Exp). Each function will be utilized in normal or inverse forms. All edge shaping functions can be applied in one of two modes, Symmetric (Sy) or Asymmetric (ASy). In Sy mode is applied to Re and Fe equally, in ASy mode Re and Fe settings are applied independently to their respective edge.
  • Figure 7(b) shows a Sy pulse with Re(LIN(S)) and Fe(LIN(S)) where Re duration (Red) and Fe duration (Fed) are shown.
  • the rate of rise/fall for a given edge is referred to as the Slew Rate (S) being a function of amplitude and time.
  • S Slew Rate
  • ⁇ a Slew ⁇ ⁇ t
  • Figure 7(c) shows a pulse with SIN applied ASy to the edges. The functions for this pulse would be Re(SIN) and Fe(SIN-1).
  • Figure 7(d) shows a pulse with Exp applied to the edges. The functions for this pulse would be Re(Exp) and Fe(Exp -1 ).
  • ADVANCED PULSE SHAPING In addition to the variable edge shaping functions, the pulse generator further allows an option to split an edge into two or more separate sections, the Attach (Ak) section and the Roll Off (Ro) section, or No Split (NS).
  • FIG. 7(e) shows a pulse which has been defined with: ReAk(Exp) – Rising edge Attach Exponential ReRo(Exp -1 ) – Rising edge Roll Off Inverse Exponential FeNS(None) – Falling edge No Split No Function (square)
  • Each edge can also have an Overshoot defined.
  • the Overshoot Amplitude (ao) is defined as a percentage of the Pulse Amplitude (a) and allows any of the provided functions to be used for the Overshoot Recovery (Or), this is the shape of the waveforms return to the Pulse Amplitude (a).
  • Figure 7(f) shows a pulse which has been defined as: ReNS(Exp)ao(10)Or(Exp-1) – Rising Edge No Split Exponential, Overshoot 10% with Inverse Exponential Recovery. FeNS(Exp-1)ao(0)Or(None) – Falling Edge No Split Inverse Exponential, Overshoot 0% with no function recovery. Note: An Overshoot can be defined for an edge which has a Roll Off defined.
  • Waveform Durations Wd
  • Sequence Duration Sd
  • Waveforms can be added to a sequence as Normal or Inverse. Sequences can be output on one or two active channels in one of two modes, that is, synchronous mode or asynchronous mode as described below.
  • Figure 7(h) shows a sequence of one Normal followed by one Inverse of the waveform defined in Figure 7(g).
  • VARIABLE OUTPUT MODES The system of the present invention may have two active output channels and a common channel, which allows one of four operational modes per active channel.
  • Variable Voltage Mode The waveform shape is applied to the channel as a voltage.
  • Variable Current Mode The waveform shape is applied to the channel as a current.
  • the voltage between the active channel and the common is dependent on the impedance of the load, but the current which flows between the active channel and the common remains variable.
  • Variable Ultrasound Voltage Mode The waveform shape is used as an envelope with which to amplitude modulate the voltage of a high variable frequency square wave.
  • Variable Ultrasound current Mode The waveform shape is used as an envelope with which to amplitude modulate the current of a high variable frequency square wave.
  • Figure 7(i) shows the ultrasound mode of the waveform from Figure 7(d).
  • Channel Modes Two channel modes may be provided. Variable synchronous mode In this mode a waveform/sequence is output on both channels simultaneously. Both active channels may output different and variable waveforms/sequences, but the amplitudes of each channel can be adjusted separately. Asynchronous mode Any defined waveform/sequence can be output on each channel, with the output alternating between the two active channels.
  • ADDITIONAL INFORMATION ‘Amplitude’ Pa variable or adjustable, Sa locked as a percentage of Pa based on waveform design. ‘Pulse Width’ PPw variable, Wd variable as a percentage of PPw based on waveform design.
  • Variables are provided for ‘Pulse Width’.
  • Modes Variable Synchronous or Variable Asynchronous.
  • Variable Sequencing Waveform basics A pulsed output waveform such as that produced by the INTS has four basic parameters. Three apply to the output pulses and one applies to the overall waveform. The first parameter applies to the pulses and is the variable Amplitude (A), this is the peak voltage applied by the pulse. In the case of the square pulse shown in Figure 7(a), the Amplitude is variable.
  • a variable amplitude of the pulses is controlled by the charge generator and can also be user defined.
  • Pulse Width controlled by the processor/generator of the present invention may deliver a variable pulse width/Gate of 5 ⁇ S to 350 ⁇ S.
  • the Pulse Width of a complex pulse such as that generated by the generator is measured between its ‘half power points’.
  • the third parameter applies to the overall waveform and is a variable Impulses per Second (IMPs) also known as the Pulse Repetition Frequency (Prf). This is the number of times a pulse is output in 1 second.
  • IMPs Impulses per Second
  • Prf Pulse Repetition Frequency
  • the time between the start of two successive pulses is the Pulse Repetition Time (Prt) as shown in Figure 7(a).
  • Prt Pulse Repetition Time
  • IMPs Pulse Repetition Time
  • the fourth and last basic parameter applies to the pulses and is a variable Polarity. This is the direction the voltage is applied by the variable pulses.
  • Figure 7(a) shows positive polarity pulses and negative polarity pulses.
  • One or more of these four basic parameters may be determined by the processor with resultant pulses delivered to the subject through one or more electrodes.
  • a time dial allows treatment stimulation times to be set.
  • Skin Resistance (ohms) The body has resistance to current flow. Most of the body’s resistance to electric current flow is at the skin. The skin acts like an electrical device such as a capacitor in that it allows more current to flow if a voltage is changing rapidly. Skin resistance can be reduced by immersion in water. Depending on the resistance, a certain amount of current will flow for any given voltage. Voltage is the force that pushes electric current through the body. A lower body resistance will mean an increase in current that will flow for any given voltage. When an applied voltage is changing, membranes of excitable tissues such as nerve and muscle cells will pass current into cells most effectively.
  • the amount of current in each tissue type will depend on the resistance of each tissue.
  • the total body resistance of a person is composed of the low internal body resistance (about 300 ⁇ ) plus the skin contact resistance (about 1000 to about 100,000 ⁇ ).
  • Skin contact resistance depends on the contact area, moisture, condition of the skin, and other factors. There is a range of current levels that produce a given effect due to individual subject differences. Immersion in water eliminates most of the skin resistance.
  • the system of the present invention may be used on the body part of a subject that is immersed in water.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physiology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un système et un procédé de stimulation d'une partie corporelle d'un sujet qui sont utiles, par exemple, pour soulager la douleur ou l'atrophie musculaire en thérapie, le système comprenant : un générateur d'impulsions (10) configuré pour délivrer un ou plusieurs signaux de stimulation électrique variables ; un capteur configuré pour détecter au moins une caractéristique physique du sujet ; un processeur (16) configuré pour déterminer des paramètres des signaux de stimulation à délivrer ; et un dispositif de commande configuré pour commander la sortie des signaux de stimulation électrique en fonction d'une rétroaction reçue en provenance du capteur, et pour cesser temporairement la délivrance des signaux de stimulation électrique lorsqu'au moins une caractéristique physique du sujet a atteint une valeur seuil.
PCT/EP2025/060568 2024-04-18 2025-04-16 Systèmes et procédés de stimulation électrique de tissus nerveux, musculaires et corporels Pending WO2025219481A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB2405454.6A GB202405454D0 (en) 2024-04-18 2024-04-18 Systems and methods for electrical stimulation of nerve, muscle and body tissues
GB2405454.6 2024-04-18

Publications (1)

Publication Number Publication Date
WO2025219481A1 true WO2025219481A1 (fr) 2025-10-23

Family

ID=91275368

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2025/060568 Pending WO2025219481A1 (fr) 2024-04-18 2025-04-16 Systèmes et procédés de stimulation électrique de tissus nerveux, musculaires et corporels

Country Status (2)

Country Link
GB (1) GB202405454D0 (fr)
WO (1) WO2025219481A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180028810A1 (en) * 2015-02-18 2018-02-01 Wearable Life Science Gmbh System for controlling stimulation impulses
US20180036531A1 (en) * 2015-02-18 2018-02-08 Wearable Life Science Gmbh Device, system and method for the transmission of stimuli
US10118035B2 (en) * 2015-02-24 2018-11-06 Elira, Inc. Systems and methods for enabling appetite modulation and/or improving dietary compliance using an electro-dermal patch
US20220386935A1 (en) * 2019-09-27 2022-12-08 Niche Biomedical, Inc. Method and system for targeted and adaptive transcutaneous spinal cord stimulation

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180028810A1 (en) * 2015-02-18 2018-02-01 Wearable Life Science Gmbh System for controlling stimulation impulses
US20180036531A1 (en) * 2015-02-18 2018-02-08 Wearable Life Science Gmbh Device, system and method for the transmission of stimuli
US10118035B2 (en) * 2015-02-24 2018-11-06 Elira, Inc. Systems and methods for enabling appetite modulation and/or improving dietary compliance using an electro-dermal patch
US20220386935A1 (en) * 2019-09-27 2022-12-08 Niche Biomedical, Inc. Method and system for targeted and adaptive transcutaneous spinal cord stimulation

Also Published As

Publication number Publication date
GB202405454D0 (en) 2024-06-05

Similar Documents

Publication Publication Date Title
US12383461B2 (en) Auricular peripheral nerve field stimulator and method of operating same
US11857783B2 (en) Implantable and non-invasive stimulators for gastrointestinal therapeutics
CA2906229C (fr) Systeme de stimulation electrique avec commande d'impulsions
KR102406800B1 (ko) 신체 조직에 자극을 전달하기 위한 디바이스 및 방법
JP5153872B2 (ja) 喉頭挙上筋リハビリテーションの方法及び装置
JP2018526142A (ja) 経皮直流電流ブロックによる神経伝導変更システム及び方法
CN110114111A (zh) 神经调节治疗的器械和方法
JP2020508839A (ja) 脊髄刺激装置
CN109125921A (zh) 一种基于诱发脑电信号的脉冲针灸治疗仪
US20120209354A1 (en) System and methods for producing and delivering electrical impulses
WO2025219481A1 (fr) Systèmes et procédés de stimulation électrique de tissus nerveux, musculaires et corporels
WO2010071613A1 (fr) Stimulateur électrique et procédé de stimulation électrique
WO2015024945A1 (fr) Systèmes et procédés pour électrothérapie combinée à une rétroaction de capteurs
RU237148U1 (ru) Устройство для билатеральной транслингвальной нейростимуляции языка
Efthimiou et al. Application of facial Neuromuscular Electrical Stimulation (fNMES) in 5 psychophysiological research–systematic review and practical recommendations 6
CN118203765A (zh) 一种联合TMS与taVNS的一体化智能治疗系统
CN120788378A (zh) 基于pfa技术的双通道驱动智能助眠枕
Thrasher et al. Electrical Stimulation and Neuroprostheses for Restoring Swallowing Function

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 25723122

Country of ref document: EP

Kind code of ref document: A1