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WO2011008222A1 - Système pour utiliser la stimulation électrique des muscles pour augmenter le flux sanguin dans des parties du corps - Google Patents

Système pour utiliser la stimulation électrique des muscles pour augmenter le flux sanguin dans des parties du corps Download PDF

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Publication number
WO2011008222A1
WO2011008222A1 PCT/US2009/057838 US2009057838W WO2011008222A1 WO 2011008222 A1 WO2011008222 A1 WO 2011008222A1 US 2009057838 W US2009057838 W US 2009057838W WO 2011008222 A1 WO2011008222 A1 WO 2011008222A1
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WO
WIPO (PCT)
Prior art keywords
electrode
operative
body part
electrodes
electrical
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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.)
Ceased
Application number
PCT/US2009/057838
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English (en)
Inventor
Philip Muccio
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Individual
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to EP20090847449 priority Critical patent/EP2453974A4/fr
Publication of WO2011008222A1 publication Critical patent/WO2011008222A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0408Use-related aspects
    • A61N1/0452Specially adapted for transcutaneous muscle stimulation [TMS]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0472Structure-related aspects
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36003Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/3603Control systems
    • A61N1/36034Control systems specified by the stimulation parameters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/10Characteristics of apparatus not provided for in the preceding codes with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2205/00Devices for specific parts of the body
    • A61H2205/10Leg
    • A61H2205/106Leg for the lower legs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0408Use-related aspects
    • A61N1/0456Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0408Use-related aspects
    • A61N1/0464Specially adapted for promoting tissue growth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0408Use-related aspects
    • A61N1/0468Specially adapted for promoting wound healing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0472Structure-related aspects
    • A61N1/0484Garment electrodes worn by the patient

Definitions

  • the described invention relates in general to a system for increasing blood flow in certain body areas of a patient, and more specifically to an apparatus and method for increasing blood flow in the trunk and extremities for medical and non-medical purposes using electrical muscle stimulation, also referred to herein as neuromuscular stimulation.
  • the causative factors surrounding the precipitation of DVT are known and include vessel wall and valvular damage and blood stasis resulting from immobilization during or following surgery. Removal of endogenous fibrinolysis which is produced by contracting muscles may also be a causative factor.
  • Muscle contractions are an integral component of the physiology of circulation.
  • SCDs sequential compression devices
  • SCDs are typically used as an adjunct therapy to facilitate blood flow to the lower extremities.
  • electrical stimulation is superior to SCDs. While cardiac output dropped 20% below baseline, the electrical stimulation group increased 20% (Faghri, IEEE 591 : 62-69; March 1997).
  • NMES Neuromuscular stimulation
  • This involuntary effect is particularly advantageous for (i) surgical patients who are anesthetized or under a local epidural block; (ii) patients who are bedridden due to disability, age, or disease; or (iii) are paralyzed from spinal cord injury, stroke, or other neurological injuries or diseases. This effect would also be useful for people who are prevented from moving for long periods of time, such as those on long-duration flights or during extended period of sleep.
  • a system for electrically stimulating muscles and increasing blood flow in one or more body parts includes at least one electrode adapted to be placed circumferentially (i.e., completely) around a body part such as an arm or leg wherein the at least one electrode is operative to deliver electrical impulses sufficient to induce muscle contractions in the body part; at least one stimulation module in electrical communication with the at least one electrode, wherein the at least one stimulation module is operative to provide electrical impulses to the at least one electrode; and at least one control module in electrical communication with the at least one stimulation module, wherein the at least one control module is operative to control the characteristics of the electrical impulses.
  • a system for electrically stimulating muscles and increasing blood flow to a body part includes at least two electrodes adapted to be placed circumferentially around a body part, wherein each of the at least two electrodes is operative to deliver electrical impulses sufficient to induce muscle contractions in the body part; at least one stimulation module in electrical communication with each of the at least two electrodes, wherein the at least one stimulation module is operative to provide electrical impulses to each of the at least two electrodes; and at least one control module in electrical communication with the at least one stimulation module, wherein the at least one control module is operative to control the characteristics of the electrical impulses.
  • a device for electrically stimulating muscles or muscle groups includes at least one electrode adapted to be placed circumferentially (i.e., completely) around a body part such as an arm, leg, or trunk, wherein the at least one electrode is operative to deliver electrical impulses sufficient to induce muscle contractions in the body part.
  • FIG. 1 depicts an exemplary embodiment of the electrical muscle stimulation system of the present invention wherein multiple electrical stimulation assemblies have been placed on multiple body parts of an individual;
  • FIG. 2 illustrates the placement of an exemplary embodiment of the electrical stimulation system of the present invention wherein a single electrical stimulation assembly has been placed on the lower portion of one leg of an individual;
  • FIG. 3 is a cross-sectional view of a limb segment depicting the flow of an electrical current into both agonist and antagonist muscle groups from the circumferential electrode of the present invention
  • FIG. 4 is a longitudinal view of a limb segment depicting the flow of an electrical current generated by the circumferential electrodes of the present invention.
  • FIG. 5 is a graph depicting an exemplary order of stimulation for pushing blood proximally using the electrical muscle stimulation system of the present invention.
  • the present invention relates to a neuromuscular stimulation system (NMES) for use in treating DVT and other medical and non-medical conditions by inducing singular and or co-contractions of muscle groups to increase blood and oxygen flow in those muscles.
  • NMES neuromuscular stimulation system
  • Other intended uses and benefits of the present invention include wound healing, muscle strengthening, and stimulation of bone growth.
  • first and second general embodiments of this invention provide a system for electrically stimulating muscles and increasing blood flow in one or more body parts such as the trunk or extremities; and a third general embodiment of this invention provides a device in the form of a circumferential electrode for electrically stimulating muscles or muscle groups, wherein the electrode is capable of completely encircling a human body part for increasing blood circulation.
  • the electrode is supplied with electrical impulses to induce muscle contractions and may be shifted proximally or distally on the body part without degradation of muscle contraction while providing for concurrent agonist and antagonist muscle regeneration.
  • FIG. 1 depicts an exemplary embodiment of neuromuscular stimulation system
  • Each assembly 20 typically includes a first circumferential electrode 22 and a second circumferential electrode 24, both of which are in electrical communication with a stimulation module 26, which is connected to each circumferential electrode by at least one wire 28 (see FIG. 2).
  • Stimulation module 26 typically communicates with control module 40 by wireless means, as depicted by reference number 27.
  • Each assembly 20 typically includes a fabric sleeve 30, which acts as a substrate or support for the components thereof.
  • One or more sleeves 30 may be included in a larger garment- like item 32, which may connect sleeves 30 to one another for the purpose a facilitating proper placement of system 10 on a user thereof.
  • FIG. 2 illustrates the placement of an assembly 20 on the lower portion of one leg of an individual.
  • FIG. 3 provides a cross-sectional view of a limb segment depicting the flow of an electrical current into both agonist muscle 50 and antagonist muscle 52 from circumferential electrode 22.
  • An electrical field 56 is generated by electrode 22 and passes through skin 54 into the muscles of the limb upon which electrode 22 has been placed.
  • FIG. 4 is a longitudinal view of a limb segment depicting the flow of an electrical current generated by the circumferential electrodes of the present invention.
  • electrodes 22 and 24 have been placed in sequence (i.e., tandem) on the leg of a patient for the purpose of creating electrical field 56.
  • FIG. 5 provides a graph that depicts an exemplary method of electrical stimulation for pushing blood proximally using an exemplary embodiment of neuromuscular stimulation system 10.
  • each muscle group (agonist and antagonist) being treated is typically controlled by one set of circumferential electrodes 22, 24 and one integrated stimulation module 26, which coordinates the electrical impulses between the electrodes, which may be controlled remotely from the electrodes.
  • stimulation module 26 is equipped with electronics and battery power used deliver adequate stimulation.
  • Each stimulation module 26 receives a wireless signal 27 from control module 40 for properly coordinating the contraction of muscle groups.
  • Stimulation module 26 may also include electronic means for monitoring contractions of a body part and providing selected electrical impulses to the circumferential electrodes.
  • stimulation module 26 has a width of approximately two inches or less and may be extensible in length.
  • control module 40 is also capable of monitoring the status of equipment, electrode impedance, compliance and blood flow and then delivering this information to clinicians. Control module 40 may be used to adjust the level of electrical stimulation in accordance with the need for increased or decreased blood flow in or out of the treated limb in a closed-loop feedback manner.
  • the circumferential electrodes of the present invention are typically 1-2 inches in width and the area of coverage is significantly higher than the conventional electrodes typically used in NMES.
  • the current density (CD) of the circumferential electrodes is significantly lower, even at high intensity outputs, meaning they are more comfortable than conventional electrodes.
  • a conventional electrode would have an area of 2 x 4 inches equaling 8 square inches; whereas a circumferential electrode (around a typical thigh) would have an area 1 x 25 inches equaling 25 square inches.
  • the electrical impulse parameters for each circumferential electrode include an amplitude of about 0.1-150 mA; a pulse width of about 0.1- 400 microseconds; a frequency of 25-50 Hz; and a duty cycle of about 5-10 seconds ON, and about 10-60 seconds OFF.
  • circumferential electrodes 22, 24 utilize either an adhesive or non-adhesive biogel to interface with the patient's skin.
  • This biogel may include hydrogel polymers, polymerized polyethylene glycol diacrylate, polylactic acid, polyglycolic acid, polymerized polyethylene glycol dimethylacrylate and mixtures thereof.
  • the circumferential electrodes of the present invention are extensible in length (including the biogel) to accommodate expansion in girth as muscle contracts so as to not constrict the limbs and to maintain electrode-to-skin contact; and are flexible for accommodating the contours of limbs which may vary widely due to variations in underlying muscle and bone.
  • Neuromuscular stimulation system 10 and the various components thereof may be provided as a portable kit that includes instructions for proper placement of the electrodes and proper use of the system.
  • a primary advantage of the present invention is that circumferential electrodes 22,
  • the circumferential electrodes 24 transmit electrical current through the patient's skin and body in a highly efficient manner.
  • the electrical current generated by these circumferential electrodes travels in a perpendicular fashion with respect to the planar surface of the electrode and then along a parallel pathway, in the long direction of the limb segment (see FIGS 3-4).
  • These aspects of the disclosed circumferential electrodes results in much less discomfort to the patient.
  • the reduced level of discomfort is also due to lower current densities emitted by the circumferential electrodes as compared to more traditional electrodes.
  • the circumferential electrodes of the present invention do not have to be placed accurately to effectively excite muscle tissue. These electrodes may be shifted proximally or distally, while still inducing muscle contractions without compromising the quality of stimulation or level of comfort.
  • the disclosed circumferential electrodes reduce the number of required electrodes and stimulation channels by one-half, making a NMES system utilizing these electrodes far easier to operate than known systems.

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  • 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)
  • Physical Education & Sports Medicine (AREA)
  • Electrotherapy Devices (AREA)

Abstract

La présente invention concerne un système pour stimuler les muscles et augmenter le flux sanguin dans une ou plusieurs parties spécifiques du corps. Ce système comprend au moins une électrode adaptée pour être placée tout autour d'une partie du corps, l'au moins une électrode opérant de manière à délivrer des impulsions électriques suffisantes pour induire des contractions musculaires dans la partie du corps ; au moins un module de stimulation en communication électrique avec l'au moins une électrode, l'au moins un module de stimulation opérant de manière à fournir des impulsions électriques à l'au moins une électrode ; et un module de commande en communication électrique avec l'au moins un module de stimulation, l'au moins un module de commande opérant de manière à commander les caractéristiques des impulsions électriques.
PCT/US2009/057838 2009-07-15 2009-09-22 Système pour utiliser la stimulation électrique des muscles pour augmenter le flux sanguin dans des parties du corps Ceased WO2011008222A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP20090847449 EP2453974A4 (fr) 2009-07-15 2009-09-22 Système pour utiliser la stimulation électrique des muscles pour augmenter le flux sanguin dans des parties du corps

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US22570309P 2009-07-15 2009-07-15
US61/225,703 2009-07-15

Publications (1)

Publication Number Publication Date
WO2011008222A1 true WO2011008222A1 (fr) 2011-01-20

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EP (1) EP2453974A4 (fr)
WO (1) WO2011008222A1 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016151159A1 (fr) * 2015-03-26 2016-09-29 María Olga Salcedo Lailla Stimulateur du flux sanguin pour les membres inférieurs
EP3010579A4 (fr) * 2013-06-21 2017-02-22 Bodyflow International Pty Ltd Acn 114 356 231 Traitement d'ulcères de la peau
CN108785850A (zh) * 2012-06-26 2018-11-13 斯凯医疗技术有限公司 用于增强微循环的设备
EP3687396A1 (fr) * 2017-09-28 2020-08-05 Smith & Nephew plc Neurostimulation et surveillance à l'aide d'un appareil de surveillance et de traitement de plaie activé par un capteur
WO2021178040A1 (fr) * 2020-03-03 2021-09-10 Garwood Medical Devices, Llc Électrode pouvant être enroulée circonférentiellement destinée à être utilisée avec des implants chirurgicaux métalliques
EP4147747A1 (fr) * 2016-06-30 2023-03-15 Novocure GmbH Réseaux pour la distribution longitudinale de champs tt à un corps
GB2634737A (en) * 2023-10-17 2025-04-23 Actegy Ltd Apparatus for stimulating muscles of a subject and method of performing the same

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US5674262A (en) * 1996-01-26 1997-10-07 Kinetic Concepts, Inc. Pneumatic compression and functional electric stimulation device and method using the same
US20030114892A1 (en) * 2001-12-18 2003-06-19 Ness Neuromuscular Electrical Stimulation Systems Ltd. Surface neuroprosthetic device having an internal cushion interface system
US20040254624A1 (en) * 2003-06-06 2004-12-16 Prizm Medical, Inc. Electrical stimulator and garment electrode connection system

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US4727878A (en) * 1985-09-26 1988-03-01 The University Of Michigan Functional electrical stimulation for pressure sore inhibition
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US5871534A (en) * 1998-07-08 1999-02-16 Messick; Genevieve M. Apparatus for treating pelvic floor dysfunctions using transcutaneous electrical stimulation of the muscles
ATE348646T1 (de) * 2000-02-17 2007-01-15 Neurodan As Implantierbares system zur neuralmessung und nervenstimulation
GB2370507B (en) * 2000-12-23 2003-07-30 Nuron Ltd Apparatus for the diagnosis and therapy of neuro-muscular and other tissue disorders
JP2005052223A (ja) * 2003-08-06 2005-03-03 Gifu Univ 末梢血液循環改善具
RU2317830C2 (ru) * 2003-09-03 2008-02-27 Фидес Финанц-Инвест Гмбх Унд Ко.Кг Устройство для мышечной стимуляции
GB0425632D0 (en) * 2004-11-22 2004-12-22 Bioaccelerate Ltd Device
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US20080097530A1 (en) * 2006-10-23 2008-04-24 Muccio Philip System for tissue stimulation and regeneration

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5674262A (en) * 1996-01-26 1997-10-07 Kinetic Concepts, Inc. Pneumatic compression and functional electric stimulation device and method using the same
US20030114892A1 (en) * 2001-12-18 2003-06-19 Ness Neuromuscular Electrical Stimulation Systems Ltd. Surface neuroprosthetic device having an internal cushion interface system
US20040254624A1 (en) * 2003-06-06 2004-12-16 Prizm Medical, Inc. Electrical stimulator and garment electrode connection system

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108785850A (zh) * 2012-06-26 2018-11-13 斯凯医疗技术有限公司 用于增强微循环的设备
EP3010579A4 (fr) * 2013-06-21 2017-02-22 Bodyflow International Pty Ltd Acn 114 356 231 Traitement d'ulcères de la peau
WO2016151159A1 (fr) * 2015-03-26 2016-09-29 María Olga Salcedo Lailla Stimulateur du flux sanguin pour les membres inférieurs
EP4147747A1 (fr) * 2016-06-30 2023-03-15 Novocure GmbH Réseaux pour la distribution longitudinale de champs tt à un corps
US11964146B2 (en) 2016-06-30 2024-04-23 Novocure Gmbh Arrays for longitudinal delivery of TTFields to a body
EP3687396A1 (fr) * 2017-09-28 2020-08-05 Smith & Nephew plc Neurostimulation et surveillance à l'aide d'un appareil de surveillance et de traitement de plaie activé par un capteur
US12290352B2 (en) 2017-09-28 2025-05-06 Smith & Nephew Plc Neurostimulation and monitoring using sensor enabled wound monitoring and therapy apparatus
EP3687396B1 (fr) * 2017-09-28 2025-08-20 Smith & Nephew plc Neurostimulation et surveillance à l'aide d'un appareil de surveillance et de traitement de plaie activé par un capteur
WO2021178040A1 (fr) * 2020-03-03 2021-09-10 Garwood Medical Devices, Llc Électrode pouvant être enroulée circonférentiellement destinée à être utilisée avec des implants chirurgicaux métalliques
GB2634737A (en) * 2023-10-17 2025-04-23 Actegy Ltd Apparatus for stimulating muscles of a subject and method of performing the same
WO2025083385A1 (fr) 2023-10-17 2025-04-24 Actegy Limited Appareil pour stimuler les muscles d'un sujet et son procédé de réalisation

Also Published As

Publication number Publication date
EP2453974A1 (fr) 2012-05-23
EP2453974A4 (fr) 2013-05-22

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