(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2012/0245483 A1
`Lundqvist
`(43) Pub. Date:
`Sep. 27, 2012
`
`US 20120245483A1
`
`(54) SYSTEMAND GARMENT FOR MUSCLE
`RELAXATION OF A SPASTIC MUSCLE
`
`(75) Inventor:
`
`Edrik Lundqvist, Stockholm
`
`(73) Assignee:
`
`INERVENTIONS AB, Solna (SE)
`
`(21) Appl. No.:
`
`13/513,223
`
`(22) PCT Filed:
`
`Dec. 2, 2010
`
`PCT/EP2010/068721
`
`(86). PCT No.:
`S371 (c)(1),
`2). (4) Date:
`Jun. 12, 2012
`(2), (4) Date:
`ll. A
`O
`O
`Related U.S. Application Data
`(60) Provisional application No. 61/283.374, filed on Dec.
`3, 2009.
`
`Foreign Application Priority Data
`(30)
`Apr. 27, 2010 (SE) .................................... 1050420-7
`Publication Classification
`
`(51) Int. Cl.
`(2006.01)
`A61N L/36
`(2006.01)
`A6IH I/00
`(2006.01)
`A6IB5/0488
`(52) U.S. Cl. ........................................... 600/546; 601/15
`(57)
`ABSTRACT
`The present invention relates generally to muscle relaxation.
`Muscle relaxation is desired in many disease states, including
`spastic paresis and biomechanical and neuromuscular dys
`function. More specifically, the invention relates to a system
`that causes muscle relaxation by reducing muscular spasticity
`through the stimulation of joints and muscles. The system
`consists of a garment with electrodes, a hardware unit and
`Software controlling the stimulation.
`
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`SYSTEMAND GARMENT FOR MUSCLE
`RELAXATION OF A SPASTIC MUSCLE
`
`TECHNICAL FIELD
`0001. The present invention relates in general to muscle
`relaxation, and more particular to muscle relaxation for spas
`tic muscles in patients having injuries to the central nervous
`system (CNS) at least by using muscle stimulation.
`
`BACKGROUND
`0002 Injuries to the central nervous system (CNS) are
`difficult to treat and cure. Spastic paresis, which is a patho
`logically increased muscle tonus caused by an injury to the
`central nervous system (CNS) is a significant obstacle for
`prevention of posturing and loss of mobility.
`0003. Today, therapeutic alternatives for the reversal of
`CNS injury symptoms, such as spasticity, are very limited.
`Therapies are constructed to prevent further loss of function,
`rather than alleviating the symptoms. No treatment has been
`found to truly give back function and, in the long run, revers
`ing the injury through muscle relaxation of spastic muscles.
`0004. In addition to the spasms themselves, musculoskel
`etal pain is a common related complaint. Pain originating
`from dysfunction in the musculoskeletal system is in most
`cases caused by muscle spasms due to muscularimbalance. If
`the pain is not treated properly, patients risk developing
`chronic pain syndromes, conditions that are difficult to cure.
`0005. There are several techniques available to affect
`muscles in the human body.
`0006 Electrical muscle stimulation (EMS), also known as
`neuromuscular electrical stimulation or electromyostimula
`tion is a commonly known method for increasing muscle
`mass in specific areas, by providing an electric current into the
`muscle causing contraction, which gradually leads to
`increased mass in the treated muscle. Trancutaneous Electri
`cal Nerve Stimulation (TENS) is closely related to EMS, but
`instead of stimulating muscles to contract, electric stimula
`tion is used to indirectly treat pain, by distracting the brain
`through the stimulation of other body parts. In U.S. Pat. No.
`4.580,572, a garment for electrical monitoring of sites or
`electrical stimulation, such as EMS is disclosed.
`0007. However, none of the currently known muscle
`stimulation techniques is Suited to provide for targeted
`muscle relaxation.
`0008 Hence, a new system, and garment allowing for
`increased muscle relaxation would be advantageous.
`
`SUMMARY OF THE INVENTION
`0009. Accordingly, the present invention preferably seeks
`to mitigate, alleviate or eliminate one or more of the above
`identified deficiencies in the art and disadvantages singly or in
`any combination and solves at least the above mentioned
`problems by providing a system and garment allowing for
`improved muscle relaxation in spastic patients.
`0010. An object of the present invention is to provide for
`muscle relaxation.
`0011
`Furthermore, the invention relates to a system that
`causes muscle relaxation by reducing muscular spasticity
`through the stimulation of several muscles and joints simul
`taneously.
`0012. Furthermore, an object is to reduce muscle spasms
`due to spastic paresis or other dysfunction of the neuromus
`cular system inducing muscle spasms.
`
`0013 Moreover, an object is to reduce posturing and
`development of contractures in patients with spastic paresis.
`0014) Another object is to give spastic patients a self
`Sufficient rehabilitation instrument enabling increased func
`tion and movement leading to better quality of life.
`0015. Another object is to reduce pain in patients with
`spastic paresis and in patients with biomechanical and neu
`romuscular dysfunction.
`0016. Another object is to produce a powerful diagnostic
`tool for therapists specialized in neurology, orthopedics and
`manual therapy.
`0017. Another object is to be a reliable research system in
`neurological research regarding brain injuries.
`0018. Another object is to getting a grading or measuring
`scale for spasticity.
`0019. According to an aspect a system for relaxation of a
`spastic antagonist muscle of a human is provided. The system
`comprises an electronic muscle stimulation device having a
`first electrode and a second electrode for connection to the
`corresponding agonist muscle. The system further comprises
`a vibrator device for connection to a ligament, joint capsule,
`or tendon to which the agonist muscle attaches to the skel
`eton. Moreover, the system comprises control unit configured
`to simultaneously control the electronic muscle stimulation
`device and the vibrator device, by applying a first pulsed
`current signal between the first electrode and the second
`electrode, and a second pulsed current signal to the vibrator
`device.
`0020. According to another aspect a garment comprising
`the system is provided.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`0021. These and other aspects, features and advantages of
`which the invention is capable of will be apparent and eluci
`dated from the following description of embodiments of the
`present invention, reference being made to the accompanying
`drawings, in which
`0022 FIG. 1 illustrates the system according to an
`embodiment;
`0023 FIG. 2 illustrates the system according to another
`embodiment;
`0024 FIG. 3 illustrates a front view of a garment accord
`ing to an embodiment;
`0025 FIG. 4 illustrates a back view of a garment accord
`ing to an embodiment;
`0026 FIG. 5 illustrates a front view of the garment com
`ponents according to an embodiment;
`0027 FIG. 6 illustrates a back view of the garment com
`ponents according to an embodiment;
`0028 FIG. 7 illustrates a front view of EMS/EMG-elec
`trode placement according to an embodiment;
`0029 FIG. 8 illustrates a back view of EMS/EMG-elec
`trode placement according to an embodiment;
`0030 FIG. 9 illustrates a front view of the vibration elec
`trode placement according to an embodiment;
`0031
`FIG. 10 illustrates a back view of the vibration elec
`trode placement according to an embodiment;
`0032 FIG. 11 illustrates a front view of all anatomic elec
`trode placements according to an embodiment;
`0033 FIG. 12 illustrates a back view of all anatomic elec
`trode placements according to an embodiment; and
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`0034 FIG. 13 illustrates a front view of garment compo
`nents, hardware placement, connection ports and cable
`bundle connectors according to an embodiment.
`
`DESCRIPTION OF EMBODIMENTS
`0035. Several embodiments of the present invention will
`be described in more detail below with reference to the
`accompanying drawings in order for those skilled in the art to
`be able to carry out the invention. The invention may, how
`ever, be embodied in many different forms and should not be
`construed as limited to the embodiments set forth herein.
`Rather, these embodiments are provided so that this disclo
`sure will be thorough and complete, and will fully convey the
`scope of the invention to those skilled in the art. The embodi
`ments do not limit the invention, but the invention is only
`limited by the appended patent claims. Furthermore, the ter
`minology used in the description of the particular embodi
`ments illustrated in the accompanying drawings is not
`intended to be limiting of the invention.
`0036 An idea is to combine EMS stimulation and joint
`tissue vibration stimulation for patients with spastic paresis
`and/or musculoskeletal pain in order to achieve improved
`relaxation in the muscle/muscles being spastic.
`0037. The combination of EMS stimulation and joint tis
`Sue vibration stimulation may also be utilized to decrease
`inflammation, decrease muscle tension and building muscles
`to treat imbalance, by utilizing a combination of EMS stimu
`lation for a muscle and vibration stimulation for a joint or
`tendon correlated to the muscle.
`0038. The present inventor has realized that by utilizing
`the generally concept of antagonist muscle pairs, together
`with combination of EMS stimulation and joint tissue stimu
`lation, spastic muscles may be relaxed when the stimulation is
`performed in a certain way. This was done by manual stimu
`lation of patients joint tissues, combined with EMS stimula
`tion. The present inventor has surprisingly found that the
`combination of simultaneous EMS stimulation and joint tis
`Sue vibration gives far better results in terms of relaxation of
`spastic muscles than utilizing EMS stimulation, and vibration
`stimulation, separately. By performing the manual stimula
`tion according to above, a number of specific advantageous
`combinations were found, which is described below.
`0039 Specifically, it was discovered that stimulation may
`have a systemic effect, i.e. that stimulation of a single muscle
`and joint or tendon correlated to the muscle, or a group of
`adjoining muscles and joints or tendons correlated to the
`respective muscles may affect muscles in a different place of
`the body.
`0040 Antagonistic pairs are needed in the body because
`muscles can only exert a pulling force, and can not push
`themselves back into their original positions. An example of
`this kind of muscle pairing is the biceps brachii and triceps
`brachii. When the biceps are contracting, the triceps are
`relaxed, and stretches back to its original position. The oppo
`site happens when the triceps contract.
`0041 Agonist is a classification used to describe a muscle
`that causes specific movement or possibly several movements
`to occur through the process of its own contraction. Each
`antagonist pair comprises an agonist muscle and an antago
`nist muscle. Hence, when the biceps brachii is contracted, it
`acts as the agonist muscle, and the triceps brachii will act as an
`antagonist muscle. On the other hand, when the triceps
`brachii is contracted, it acts as the agonist muscle, and the
`biceps brachii will act as an antagonist muscle.
`
`0042. The present inventor has found that mild agonist
`muscle stimulation leads to reciprocal inhibition of the
`antagonist muscle and slight contraction without shortening
`of the agonist muscle. The joint tissue stimulation facilitates
`the agonist activation and relaxes the antagonist muscle
`through reciprocal inhibition. The concept consists of co
`stimulation of several muscles and joint tissues simulta
`neously to induce muscle relaxation in a group of spastic
`muscles. The idea behind the muscle stimuli is to easily
`stimulate the agonist muscle without shortening it. The ner
`Vous system senses the stimulation, whereby the antagonist
`muscle experiences so called reciprocal inhibition and is pro
`longed due to relaxation, which indirectly leads to a shorten
`ing of the stimulated agonist muscle.
`0043 Prolonged stimulation leads to a general muscle
`relaxation and reduced muscle spasms in the whole body.
`Weak muscles are made stronger which in the long run leads
`to a generalized reduction of muscle spasms and musculosk
`eletal pain; therefore reducing disability and Suffering.
`0044 EMS+Vibration
`0045. In an embodiment, according to FIG. 1, a system 10
`for relaxation of a spastic antagonist muscle of a human is
`provided. The system comprises an electronic muscle stimu
`lation device 11 having a first electrode 11a and a second
`electrode 11b for connection to the corresponding agonist
`muscle. The system 10 further comprises a vibrator device 12
`for connection to a ligament, joint capsule, or tendon to which
`the agonist muscle attaches to the skeleton. Moreover, the
`system comprises a control unit 13 configured to control the
`electronic muscle stimulation device 11 and the vibrator
`device 12, by applying a pulsed EMS current signal between
`the first electrode 11a and the second electrode 11b, and a
`pulsed vibrator current signal to the vibrator device 12.
`0046. Usually, patients having CNS injury symptoms, has
`several spastic muscles, which heavily limits their mobility
`and life quality. According to an embodiment the system
`comprises an electronic muscle stimulation device or a pair of
`first and second electrodes for each agonist of each spastic
`antagonist muscle to be treated, and a vibrator device for each
`corresponding ligament, joint capsule, or tendon to each ago
`nist muscle of each spastic antagonist muscle to be treated.
`0047. In an embodiment, the system comprises a first elec
`trode and second electrode for the majority of the agonist
`muscles in the human body, as well as a vibrator device for
`each of the agonist muscles. The present inventor has realized
`that by utilizing a system providing the majority of the
`antagonist pair muscles in the human body with the EMS
`electrodes, as well as the corresponding joint tissue with
`vibrator devices, even though not all of the majority of
`muscles in the body are spastic, an increased relaxation for
`the truly spastic muscles is achieved, by Stimulation of the
`majority of the muscles. This is believed to be the result of the
`nerve inhibiting signal Substances being released to the Syn
`apses and the cerebrospinal fluid, circulating the brain and
`spinal cord. Therefore other synapses and neurons can be
`affected if in proximity of either the site of release or the
`cerebrospinal fluid. It is e.g. commonly known that decreased
`spasticity in the legs leads to decreased spasticity in the arms.
`The first electrode 11a and/or second electrode 11b may be
`any known EMS electrode suitable for the purpose of muscle
`relaxation, and allowing for reduced discomfort for the
`patient. Each of the first electrode 11a or second electrode
`11b acts as a +/-node and is designed to electrically stimulate
`the muscle to which it is connected.
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`0048. The size of the first 11a and/or second 11b EMS
`electrode is selected based on the muscle to be treated.
`0049. In an embodiment, the first and/or second electrode
`may be directly attached to the skin by means of an adhesive,
`Such as conductive pads or conductive gel.
`0050. The electrodes may e.g. be silicone electrodes, com
`bined with conductive gel. Important properties for elec
`trodes are good skin contact/adhesiveness, good conductivity,
`hypoallergenic properties and durability.
`0051 Pulsed EMS Current Signal
`0052. In general, the parameters of the EMS current signal
`may be chosen which resemble the physiology of the body.
`The signals in the nervous system may be compared to current
`impulses (stimuli) to the synapses. When a certain amount of
`stimuli has occurred, signal Substances are excreted.
`0053 Generally, a phasic EMS-stimulus is given with a
`frequency ranging between 2 and 50 Hz, with a duration
`between 5 to 300 microseconds.
`0054 Muscle relaxation in spastic muscles gives the pos
`sibility to induce controlled functional muscle contraction in
`chosen relaxed muscles. The frequency needed to induce
`muscle contraction is higher than the frequency used for
`optimal antagonist muscle relaxation (20 HZ/30 micros).
`Stimulation frequencies for functional muscle contraction are
`ranging from 25 to 50 Hz, and the duration needed is between
`50-300 microS.
`0055. The pulsed EMS current signal is controlled by at
`least the following parameters; pulse frequency, pulse dura
`tion, pulse strength.
`0056 Experiments have shown that muscles start to con
`tract at a pulse frequency of approximately 15 Hz to approxi
`mately 35 HZ, at which frequency range the central nervous
`system feels the presence of the current signal. The present
`inventor has realized that by choosing a frequency as low as
`possible, but still detectable by the central nervous system,
`the discomfort for the patient is reduced, while the automatic
`relaxation of the spastic antagonist muscle is taken care of by
`the central nervous system. A higher frequency than approxi
`mately 35 Hz would lead to shortening of the stimulated
`agonist muscle and therefore activation of the stretch reflex in
`the antagonist muscle which is not desired, since this would
`lead to a reciprocal spasm of the agonist muscle.
`0057 The pulse duration of the current signal is selected
`Such that it resembles the pulse duration of nervous signals.
`For example, a pulse duration of approximately 5 to 60 micro
`seconds, such as 30 us, has been found to be suitable. How
`ever, even shorter pulse duration could be advantageous. Too
`long pulse duration of the EMS current signal does not cor
`respond to the neurophysiologic parameters of the body. Fur
`thermore, longer pulse duration may also increase the risk of
`muscle shortage, which is not desired.
`0058. In an embodiment, the pulsed EMS current signal
`has a pulse frequency ranging between 10 and 30 Hz with a
`pulse duration ranging between 5 to 60 microseconds.
`0059. According to a preferred embodiment the pulsed
`EMS signal has a pulse frequency of 20 Hz, with pulse dura
`tion of 30 microseconds.
`0060. The EMS current signal strength is selected such
`that it does not exceed the amplitude at which the skin adja
`cent to the first 11a and/or second 11b EMS electrodes starts
`to vibrate. In use, the vibrating, painfree sensation may be felt
`by some patients. Stronger current signals may produce
`muscle shortening and pain in the patient, which is not
`desired. Preferably the current signal strength is selected to lie
`
`in the range of 50% to 75% of the signal strength required to
`feel the vibration in the skin adjacent the first and/or second
`electrode, in use. Hence, the pulsed EMS current signal
`strength does not provide discomfort for the patient, however
`a sparkling ortingling sensation may be felt in some patients.
`
`Vibration Device
`0061. In an embodiment, the vibration device 12 is a micro
`vibration motor, designed to stimulate joint proprioception in
`joint to which is in contact. The vibration device is small,
`round, cylindrical and covered by rubber to enhance friction
`with skin and therefore directing the vibration stimuli to joint
`tissues underlying the skin.
`0062 According to an embodiment the pulsed vibrator
`current signal has a pulse frequency ranging between 5 Hz to
`400 HZ.
`0063 Vibration stimulus is given in three primary fre
`quencies, designated to stimulate three important sensory
`receptors. One frequency is chosen to stimulate Pacinian
`corpuscles, one frequency is chosen to stimulate Merkel’s
`disk receptors and one frequency is chosen to stimulate
`Meissner's corpuscles. The frequency range chosen for
`stimulating Merkel's disk receptors is 5-15 Hz. The fre
`quency for Meissner's corpuscles is ranging between 20-50
`HZ and for Pacinian corpules the stimulation frequency
`ranges between 60-400 Hz. Optimal vibration is defined as
`the mean of these ranges.
`0064 EMG
`0065. In an embodiment according to FIG. 2, the system
`10 further comprises an Electromyography (EMG) device 14
`for evaluating and recording the electrical activity in the
`spastic antagonist muscles.
`0.066
`Based on the electrical activity in the spastic antago
`nist muscle, before and/or during EMS stimulation and vibra
`tion stimulation, the parameters of the EMS current signal or
`vibration current signal may be adapted.
`0067. The EMG device 14 comprises a first EMG elec
`trode 14a and a second EMG electrode 14b for each muscle
`for which the electrical activity is to be monitored.
`0068. The EMG electrode may be of the same type as the
`EMS electrodes 11a, and 11b. Hence, in an embodiment, the
`first 11a, and/or the second 11b electrode of the electronic
`stimulation device, may each act as an EMG electrode for
`together detecting electric signals in the muscle to which they
`are connected.
`0069. In use, the EMG-electrodes 14a, 14b are placed to
`be in contact with the spastic antagonist muscle, whereas the
`EMS electrodes 11a, 11b are to be placed in contact with the
`corresponding agonist muscle.
`0070 Calibration
`0071 Since the spastic muscle behavior in CNS injured
`patients differs greatly, the professional skills of a neuromus
`cular system specialist is required for calibrating the system
`before use. Such that the correctagonist muscles are provided
`with EMS electrodes and joints corresponding thereto are
`provided with vibrator devices. Every chosen muscle stimu
`lation is paired with an anatomically relevant joint stimula
`tion in order to strengthen the desired relaxation effect. Fur
`thermore, the parameters of the pulsed EMS current signal
`need to be selected, which parameters may differ between
`patients.
`0072 According to a non limiting theory of the inventor,
`the current level may need individual adjustment, since some
`muscles lies deeper than others. However, the frequency and
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`pulse duration of the EMS current signal may be more or less
`independent of individual spasticity level, since the nervous
`system does not vary very much between patients.
`0073 Relaxation is initially induced by antagonist muscle
`stimulation by the therapist. The therapist is aided by EMG
`readings showing the relaxation of spastic key muscles. The
`process is called spasticity calibration. The amount of stimuli
`needed (currentxtime, Ixt) gives the amount of energy needed
`to induce reciprocal inhibition of the antagonist muscle. The
`easier the reciprocal inhibition is induced the lower is the
`severity of spasticity. Therefore the therapist can, aided by
`this process, establish the exact amount of stimuli needed for
`every patient.
`0074. During calibration, at least one muscle is chosen for
`spasticity calibration, e.g. based on the readings from the
`EMG device connected to said muscle. The muscle read by
`the EMG device may be the spastic antagonist muscle.
`0075. It is commonly known that spasticity in one muscle,
`may give rise to spasticity in another muscle. Hence, a
`decrease in spasticity in the legs leads to a decrease in spas
`ticity in the arms. Hence, by reading the electrical activity in
`a number of muscles, during calibration, a measure of the
`patient's general muscle spasticity may be obtained (an indi
`cation of mass reflex activity for said patient).
`0076 According to a preferred embodiment applied to the
`whole body, muscles may also be chosen, Such as at least
`three EMG-reading muscles, i.e. three muscles connected to
`the EMG device. For example, one pair of EMG electrodes in
`the arm, one pair of EMG electrodes in the leg and one pair of
`EMG electrodes in the spine or jaw, wherein each pair of
`EMG electrodes are connected to the EMG device. One
`EMG-electrode used for reading of non-muscular electrical
`Surface activity may be placed in a bony area without under
`lying muscle to give a measurement for comparison, used for
`calibration.
`0077. An advantage of this embodiment is that it is pos
`sible to measure the general spasticity and/or general relax
`ation based on EMG readings from only a few of the muscles
`in the patient.
`0078. Another advantage is that the muscles being read by
`the EMG device may be located at some distance from the site
`of the intended EMS stimulated muscles, whereby the leaking
`of current from the EMS electrode to the EMG electrode is
`reduced.
`0079. In an embodiment, calibration may be performed
`during treatment by the system.
`0080 Control Unit
`0081. The control unit comprises a processor for running
`software and a memory onto which the software is stored. The
`control unit may be connected to a power source or a pulse
`generator for generating the pulsed EMS signals, and vibrator
`signals.
`0082. The control unit is portable, and connected with the
`electrodes in the garment and is able to connect to a personal
`computer via e.g. USB or Bluetooth. Different treatment pro
`grams and patterns can be stored in the memory. The control
`unit is configured to run code segments for controlling the
`functionality EMS device 11, vibrator device 12, and option
`ally the EMG device 14 of the system.
`0083. In an embodiment a computer program product is
`provided. The computer program product is stored on a com
`puter-readable medium comprising the Software code
`adapted for controlling the system when executed on a data
`processing apparatus.
`
`I0084 the code segments for controlling the system
`according to some embodiments.
`I0085. In an embodiment the control unit is configured to
`send treatment information to an external device. The treat
`ment information may, e.g. comprise information regarding
`the treatment progress, i.e. improvements in relaxation of the
`muscles. The therapist may receive this information and
`update the treatment strategy, change treatment plan etc.
`I0086. In an embodiment, the control unit is configured to
`receive updated Software from an external device. Such as a
`computer. The updated Software may e.g. be new treatment
`plans, stimulation programs received from the therapist.
`Hence, the system may be updated without the need for a visit
`at the therapist.
`I0087. The external device may comprise software for per
`forming calibration, to control EMS-programs, vibration pro
`grams and EMG-measurements enabling the spasticity cali
`bration mode. Treatment parameters, such as EMS current
`signals, Vibration current signals, treatment time, muscles to
`be treated etc. are utilized in order to create treatment plans.
`The external device Software may comprise a code segment
`for visualizing the system parameters on a display. Hence,
`when therapist selects a stimulation muscle and electrode and
`vibration stimuli placement, this is visualized on the display.
`0088 Treatment Duration
`0089. In an embodiment the treatment duration is one to
`two hours daily, or for a longer duration if the system is only
`used 2 to 4 times a week.
`0090. Garment
`0091. In an embodiment, according to FIGS. 3 and 4, a
`garment 30 comprising the system is provided. Hence, the
`EMS-electrodes, vibrator devices, optional EMG-electrodes
`and the control unit are all included in the garment 30.
`0092. The garment 30 makes it possible for a patient to
`receive treatment wherever he/she is without the need for an
`attending specialist or healthcare personnel. This greatly
`increases the quality of life for the patients and relatives, since
`no trips to the health care clinic are required, as well as the
`patient may retrieve treatment everywhere, as long as the
`garment 30 is worn.
`0093. In an embodiment according to FIGS. 5 and 6, the
`garment 30 comprises seven interlocking parts. One part 51
`for the head and neck; two parts 52a and 52b for elbow,
`forearm and hand; one part 53 for torso, shoulder and upper
`arm; one part 54 for lowerback, lower abdomen, pelvis, thigh,
`hip and upper leg; and finally two parts 55a and 55b for knee,
`lower leg and foot. All parts can be connected to a hardware
`unit 131 separately or in different combinations, these com
`binations ranging from two parts to all seven parts depending
`on the needs of the patient. FIG. 13 illustrates the connection
`points 130 of the parts of the garment.
`0094. It should be appreciated that only a part of the gar
`ment, according to the previous embodiment, may be used,
`depending on the needs of the individual patient. Hence, for
`Some patient there is no need for a full body garment, but one
`or more parts may be sufficient to allow for effective treat
`ment.
`0.095 According to an embodiment, the garment com
`prises of five major textile and Support materials. Elastic
`spandex for areas covering muscles and, embedded in this
`spandex, muscle electrodes for skin contact; firm elastic span
`dex textile in joint areas to induce joint stability and specific
`skin contact of embedded muscle and vibration electrodes;
`and Velcro to interlock the garment parts and also induce joint
`
`LUMENIS EX1012
`Page 18
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`US 2012/0245483 A1
`
`Sep. 27, 2012
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`stability and electrode skin contact. Zippers are placed in the
`different garment parts to enable simple dressing and use of
`the garment. Padding and other supportive materials are
`placed between the textile layers to enhance stability and
`electrode skin contact.
`0096. In order to provide for a perfect garment fit for each
`patient, each garment may be tailor made for each patient.
`Hence, each patient may be individually measured. Based on
`the calibration made by the specialist, the therapist chooses
`which muscles to stimulate and therefore induce muscle
`relaxation of corresponding spastic muscles. The tailor made
`garment is produced and the control unit is programmed with
`the necessary parameters such as to perform a vibrator and
`EMS stimulation in the prescribed manner.
`0097 Based on the individual measurements, a tailor
`made garment may be provided. Sufficient data is sent to a
`factory to ensure tailor made production and delivery of a
`functional garment. Final tailoring (e.g. minor adjustments of
`the garment), calibration and hardware unit programming
`may be performed after construction and delivery of the gar
`ment.
`0098. In another embodiment, the garment may be chosen
`from a big variety of garment component sizes which are
`combined to fit all different possible size requirements.
`0099. The design of the anatomical measurement charts
`enables exact anatomical positioning of electrodes stimulat
`ing specific muscles.
`0100. The type of the first and second electrodes for each
`muscle may be selected based on muscle type, and their
`location in the garment, such as to avoid discomfort for the
`person being treated. Essentially two types of EMS-elec
`trod