Wave Neuroscience EX2008
`PeakLogic v. Wave Neuroscience
`IPR2022-01550
`
`

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`US 10,350,427 B2
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`Page 2
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`References Cited
`U.S. PATENT DOCUMENTS
`
`FOREIGN PATENT DOCUMENTS
`WO 2006134598 A2 * 12/2006 uw. A61N 2/006
`WO
`WO 2009/023680 Al
`2/2009
`WO
`
`8,585,568 B2—11/2013 Phillipset al. WO WO-2009/023680 Al 2/2009
`
`
`8,690,748 BL*
`4/2014 Fu wie AGIN 1/0476
`WO
`WO 2012/048319 A2
`4/2012
`600/15
`WO
`WO 2013/006670 A2
`1/2013
`WO
`WO 2013/038400 Al
`3/2013
`WO
`WO 2013/121359 A2
`8/2013
`
`(56)
`
`8,870,737 B2
`8,888,672 B2
`8,888,673 B2
`8,926,490 B2
`8,961,386 B2
`2007/0225776 Al
`2008/0200749 Al
`2009/0112281 Al
`2010/0185042 Al
`2010/0185256 Al
`2010/0210894 Al
`2010/0256438 Al
`2010/0286470 Al
`3011/0082326 Al
`2011/0319700 Al
`2012/0053449 Al
`
`10/2014 Phillips et al.
`11/2014 Phillips et al.
`11/2014 Phillips et al.
`1/2015 Phillips et al.
`2/2015 Phillips etal.
`9/2007 Fritsch et al.
`8/2008 Zhengetal.
`4/2009 Miyazawaetal.
`7/2010 Schneideretal.
`7/2010 Hulvershorn
`8/2010 Pascual-Leoneetal.
`10/2010 Mishelevich et al.
`11/2010 Schneideret al.
`4/2011 Mishelevich et al.
`[2/2011 Schneider
`3/2012 Mosesetal.
`
`
`
`a
`OTHER PUBLICATIONS
`.
`.
`“
`.
`_,
`Sullivan, Thomas J. et al.,
`“A brain-machine interface using dry-
`contact, low noise EEG sensors,” JEEE International Symposium on
`Circuits and Systems, Jun. 2008, p. 1986-1989.
`Tada,K.et al., “Graphene magnet realized by hydrogenated graphene
`»
`.
`.
`5
`:
`nanopore arrays,” Applied Physics Letters, 2011, 99(18):1-3.
`Belle, D., “Graphene goes magnetic.” nanoltechweb.org.Nov. 17,
`2011. <URL = hitp://nanolechweb.org/cws/arlicle/lech/47854>.
`
`* ciled by examiner
`
`

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`U.S. Patent
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`US 10,350,427 B2
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`U.S. Patent
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`Jul. 16, 2019
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`qd) db O vy
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`@ eeg
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`FIG. 5
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`(Da
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`O yw
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`Sheet 4 of 8
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`FIG. 6
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`FIG.7
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`Sheet 7 of 8
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`U.S. Patent
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`Jul. 16, 2019
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`Sheet 8 of 8
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`US 10,350,427 B2
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`FIG. 10a
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`

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`US 10,350,427 B2
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`1
`RTMS DEVICE
`
`CROSS-REFERENCE TO RELATED
`
`T.
`
`APPLICATIONS
`
`
`
`under
`priority
`claims
`application
`present
`The
`35 U.S.C. § 119(e) to U.S. Provisional Applications No.
`61/621,413, filed on Apr. 6, 2012 the disclosure of whichis
`incorporated herein by reference inits entirety.
`
`FIELD OF THE INVENTION
`
`The present invention relates to novel repetitive transcra-
`nial magnetic stimulation (rTMS) devices that are capable of
`simulating two or more regions in the brain of a patient
`treated with such a device. The present invention alsorelates
`to graphene phased array magnets.
`
`
`
`BACKGROUND OF THE INVENTION
`
`‘lranscranial magnetic stimulation (MS) is a procedure
`that uses magnetic fields to stimulate nerve cells in the brain
`to improve symptomsof depression and other neuropsychi-
`atric conditions. Traditionally, TMS coils have been of a
`circular or figure-8 shape, designed to achieve maximum
`strength at a single point. For treatment of depression with
`standard TMS, a large electromagnetic coil is placed against
`or near the scalp near the forehead. The electromagnet used
`in TMScreates electric currents and magnetic fields that
`stimulate nerve cells in the region of your brain involved in
`mood control and depression.
`‘The design of ‘MScoils can vary based on, for example,
`the type of material used to construct the core ofthe coil, the
`geometry of the coil configuration and the characteristics of
`the pulse produced bythe coil. The coil is generally com-
`posed of a ferromagnetically active material and is generally
`called a ‘solid-core’ design. Several different types of coils
`exist, each of which produce different magnetic field pat-
`terns which include round coils. figure-eight coils, double-
`cone coils and four-leaf coils. Design variations in the shape
`of the TMScoils allows for variable penetration of the brain
`with the magnetic field generated by the coils. TMS devices
`generally are configured to treat one area of the brain at a
`time. In cases where multiple areas of the brain are desired
`to be treated then sequential
`treatments of the different
`regions of the brain are required.
`The present invention provides novel r™MSdevices that
`are capable of stimulating two or more regions in the brain
`of a patient treated with such a device when rTMS is
`required to generate synchronous TMS pulses that affect
`multiple regions of the brain.
`
`SUMMARYOF THE INVENTION
`
`Briefly, in accordance with the present invention, a repeti-
`tive transcranial magnet stimulation (rTMS) device is used
`to treat neuropsychiatric conditions or to improve physi-
`ological functions wherein the device contains a housing
`that conformsto the shape ofa head of a patient or a portion
`ofthe patient’s head and a coil to deliver a magnetic field.
`The coil configuration produces a magnetic field capable of
`delivering magnetic simulation to two or more regions of a
`brain of a patient fitted with the rTMS device. The coil
`configuration comprises 2 or more coils or alternatively a
`single coil that is shaped to deliver magnetic stimulation to
`two or more regionsof the brain ofthe patient. The geometry
`
`2
`of the coil configuration can be a phased-array of magnetic
`field emitting devices, allowing complex geometries and
`emission ficlds.
`
`the rTS device of the present invention
`Additionally,
`can be a cap worn by a patient that has a plurality of
`graphene magnetic emitters that make up an array. The cap
`is made of anyfabric suchas a cloth fabric mesh. Synthetic
`polymer meshescanalso be used. The emitters are affixed to
`the cap to make an array ofemitters across the whole head
`of the patient. The cap is worn on the head of the patient
`where the emitters can produce desired magnetic fields by
`programming software that controls each emitter. The
`array’s elements are driven by software that turns on and off
`each emitter to optimize the shape and placement of the
`magnetic lobes resulting in a phased array. The cap can
`additionally be fitted with touch-less EEG sensors so that a
`patient’s EEG can be monitored in addition to providing
`rTMS.
`
`The rTMS device of the present invention can deliver
`magnetic stimulation to the front and rear regions of the
`brain; the motor cortex and frontal cortex regions of the
`brain: or the lateral sides of the frontal lobe region of the
`brain. Preferably, the coil configuration is synchronized to
`promote coherence and synchronous behavior between mul-
`tiple locations in the brain.
`The present r[TMS device can be used to enhance or
`improve physiological functions and to treat neuropsychi-
`atric disorders or conditions. Physiological functions include
`concentration, sleep, alertness, memory, blood pressure,
`stress, libido, speech, motor function, physical performance,
`cognitive function,
`intelligence, height (in children) and
`weight. A neuropsychiatric condition or disorder includes
`Autism Spectrum Disorder (ASD), Alzheimer’s disease,
`ADHD, schizophrenia, anxiety, chronic pain, depression,
`coma, Parkinson’s disease, substance abuse, bipolar disor-
`der, a sleep disorder, an eating disorder, tinnitus, traumatic
`brain injury, post traumatic stress syndrome,and fibromyal-
`gia.
`Ofparticular interest in practicing the present invention is
`an rTMSdevicethatis used to treat disorders that have poor
`coherence across different regions of the brain, such as, for
`example, Alzheimer’s disease, speech and language disor-
`ders, schizophrenia and depression, by providing a device
`that can treat 2 or more regions ofthe brain simultaneously.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`
`
`FIG. 1 shows an embodiment of a db graphene emitter.
`FIG. 2 shows an embodiment of a yy graphene emitter.
`FIG. 3 shows a touch-less EEG sensor.
`FIG. 4 is a top viewof a patient wearing a rTMScap that
`contains two types of graphene emitters and touch-less EEG
`sensors.
`
`FIG. 5 is a top viewofa patient wearing a rTMScap that
`contains two types of graphene emitters.
`FIG. 6 is a top viewof a patient wearing a rTMScap that
`contains two types of graphene emitters.
`FIG. 7 shows a multi-loop coil that provides separate
`magnetic field sources at various regions of the brain. ‘he
`coils are connected together so as to provide a set of
`synchronized magnetic fields across the brain.
`FIG. 8 shows a phased array configuration. In this con-
`figuration, the phase of the magnetic field pulses may be
`altered so as to provide additive or subtractive interference
`with each other, thereby creating a specific magnetic field
`pattern.
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`US 10,350,427 B2
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`3
`FIG. 9 shows the results of an EEG and brainwave map
`including the powerdistribution in a top view topographyon
`an individual before treatment with rTMS.
`FIG. 10a shows a normal FIG. 8 coil and FIG. 105 shows
`an extended or elongated FIG. 8 coil
`that produces a
`magnetic field that stretches along the region underneath the
`coil, influencing all areas of the brain that lie within this
`region.
`
`DETAILED DESCRIPTION OF TILE
`INVENTION
`
`In practicing the present invention, a repetitive transcra-
`nial magnetic stimulation (*TMS) device is made to contain
`a housing that conforms to the shape of a head ofa patient
`and/or to one or more portions of a human head. Different
`sizes can be madeto treat pediatric, adolescent and adults.
`The present device also contains a coil to deliver a magnetic
`field. The coil configuration produces a magnetic field
`capable of delivering magnetic stimulation to two or more
`regions ofa brain of a patient fitted with the rTMSdevice.
`The coil configuration can be 2 or more coils or, alterna-
`tively, a single coil
`that
`is shaped to deliver magnetic
`stimulation to two or more regionsofthe brain ofthe patient.
`Alternatively, the geometry of the coil configuration may be
`a phased-array of magnetic field emitting devices. allowing
`complex geometries and emission fields. Graphene-based
`magnets are also useful
`in the practice of the present
`invention.
`
`In a preferred embodiment of the present invention, the
`rTMSdevice is a hat or a cap worn by a patient where the
`cap has a plurality of magnetic graphene emitters that make
`up an array. The cap is made of any fabric such as a cloth
`fabric mesh. Synthetic polymer meshes can also be used.
`The emitters are affixed to the cap to make an array of
`emitters across the whole head of the patient. The cap is
`wom on the head of the patient where the emitters can
`produce desired magnetic fields by programming software
`that controls each emitter. ‘he array’s elements are driven
`bysoftware that turns on and off each emitter to optimize the
`shape and placement of the magnetic lobes resulting in a
`phased array. FIG. 5 shows a top view of anrTMScapfitted
`on a patient where the nose 501 is seen at the top of the
`drawing and the ears 502, 503 are seen at the sides.
`The present emitters are used to create a flat-foot-print,
`curved placement, coordinated phased-array using graphene
`emitters. Graphene (carbon nano-tubefibers) wire is used to
`make small coils. Because of the very low resistance that
`graphene has and the nano structure of the graphenefibers,
`very small electromagnetic coils can be made as opposed to
`current electromagnetic coils which require large diameter
`wires in orderto reducetheresistancethat result in bulking,
`heavy coils. The small size of the graphene electromagnetic
`coils allows for many unique applications especially when
`combined with sensors. Such applications include but are
`not limited to medical applications employing magnetic
`stimulation, industrial processing, biological mixing, break-
`ing upbiofilms, colloidal processing, magneto drives and the
`like. In such applications the graphene electromagnetic coils
`can be made in different spatial configurations where each
`configuration creates a specific magnetic field. The use of
`differently shaped graphene electromagnetic coils can be
`used to optimize overall magnetic field direction properties
`desired for any given application.
`One type of graphene electromagnetic coil or graphene
`emitter is shown in FIG. 1 which is called a dog-bone (db)
`emitter where the graphenefibers are coiled in a dog-bone
`shape. In PIG. 1 an oblong central shaft 105 is covered with
`
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`wi 2
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`wi on
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`4
`graphene fiber coils (emitters) 106 and is contained in
`winding disc 103. A magnetic radiating shell 104 covers the
`graphene coils 106. A cable strain rclicf 101 runs to a
`processing, unit (not shown). Rim 107 contains the winding
`disc and is attached to a substrate 108 by threads 102. The
`substrate is any materials where it is desired to have the db
`emitter in use such as, for example, a cap in the application
`of an rT™MSdevice as described herein. Whenelectricity is
`passed throughthe db emitter the magnetic field spills out of
`the ends of the emitter and the lobes are wide and globular.
`In a TMSapplication this would produce skull penetration
`and will attract or repel other lobes from other emitters back
`to the brain.
`Another type of graphene electromagnetic coil or gra-
`phene emitter is shown in FIG. 2 which is called a yo-yo (yy)
`emitter where the graphenefibers are coiled in a shapelike
`a yo-yo string would be attached to a yo-yo. In FIG. 2 a
`round central shaft 201 is covered with graphenefiber coils
`(emitters) 206 and is contained in a magnetic radiating shell
`203. A cable strain relief 202 runs to a processing unit (not
`shown). The emitter is attached to a substrate 204 by thread
`205. ‘Lhe substrate is any material whereit is desired to have
`the db emitter in use such as for example a cap in the
`application of a TMS device as described herein. When
`electricity is passed through the yy emitter, the majority of
`the magnetic field spills out of the ends of the round shaft
`201 perpendicular to the graphene fiber coils 206. In an
`rIMSapplication one half of the generated magnetic field
`would be directed to the skull and the other half away from
`the head.
`The present graphene electromagnetic coils are preferably
`used with a sensor where the particular sensor would be
`chosen for the particular use of the coils. For TMS appli-
`cation a touch-less dry clectrode EEG sensor would be used
`in combination with the graphene emitters. Touch-less dry
`electrode EEG sensors are commercially available from
`Cognionics, San Diego, Calif. FIG. 3 shows an EEG touch-
`
`less dry-electrode EEG sensor that contains a PCB board
`303 housed in an EEGsensorshell 301. A cable strain relicf
`302 runs to a processing unit (not shown). The sensor is
`attached to a substrate 305 by thread 304.
`In a preferred embodiment of the present invention, db
`emitters, yy emitters and touch-less dry electrode EEG
`sensors are used to make a TMScap that can both detect
`
`EEG patterns and administer transcranial magnetic stimu-
`lation to a patient by producing a phased array effect.
`As shown in FIG. 4, each emitter 404, 405 and EEG
`sensor 406 is a generally flat disc 404, 405 and 406 that is
`in the basic shape of a circle. The emitters and sensors are
`butted-up against each other, attached to the fabric mesh,
`and vary in starting sequence and vary in position from row
`to row. he emitters 404, 405 and sensors 406 are connected
`by wires (not shown) to a control panel (not shown) that
`contains the programmed software and power supply. There
`are two types of emitters shown in FIG. 4 and are named
`herein based on their shape. One is referred to as the
`dog-bone (db) emitter 404 and the otheris referred to as the
`yo-yo (yy) emitter (405). There are two preferred patterns
`for placing the emitters and sensors on the cap: (1) -[db]-
`[ceg]-[yy]- and (2) -[yy]-[ecg]-[db]-. The basic pattern that
`is laid-down and attached is follows:
`-[db]-[eeg]-[yy]-[db]-[eeg]-Lyy]-[db]-Leeg]-Lyy]-
`-[db]-Lyy]-Leeg]-[db]-Lyy]-[eeg]-[db]-Lyy]-[eeg]-
`-[eeg]-[vy]-[db]-[eeg]-[yy]-[db]-[eeg]-[yy]-[db]-
`
`
`
`TootseeeMbligeLeetMibhosteeck
`
`-[db]-Lyy]-[eeg]-[db]-[yy]-[eeg]-[db]-Lyy] -[eeg]-
`[
`-[eeg]-[yy]-[db]-[eeg]-[yy]-[db]-[eeg]-[yy][db]-
`
`

`

`5
`The emitters 404, 405 and sensors 406 are sewn on, or
`attached. by other means, like buttons, over the whole cloth
`meshfitted to cover a head. ‘he sensors and emitters should
`
`6
`control panel (not shown) that contains the programmed
`software and powersupply. The embodiment shownin FIG.
`6 is similar to the embodiment shown in FIG. 5 with the
`
`US 10,350,427 B2
`
`not overlap. An average size cap will contain 45 ceg sensors,
`45 Db emitters, and 45 Yy emitters.
`The two types of emitters, db and yy, produce an array
`that
`is used to shape and optimize the magnetic field
`direction. ‘This “Phased-Array”is controlled by software and
`the magnetic field can be adjusted accordingly. The phasing
`of the magnetic array is accomplished through software
`control of the magnitude, position and orientation of each
`separate emitter, in sequence, through time. Since opposite
`fields attract each other, the lobes can effectively be focused
`to a targeted area of the scalp and underlying brain struc-
`tures. The size of the emitters and sensorsis not critical to
`the practice of the present invention. The diameter of the
`emitters and sensors is typically in the range of 15-30
`millimeters (mm) and preferably 17-19 mm. Anaveragesize
`cap will contain about 45 eeg sensors, 45 db emitter and yy
`emitters.
`In the yy emitters the majority of the magnetic field spills
`out the endsof the post, perpendicularto the direction of the
`disks. So half of the field tends toward the direction of the
`
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`brain, as the yy emitter lays on its side, against the head and
`the other half out into space away from the brain. In the db
`emitters the opposite happens. The magnetic field spills out
`the ends of the db emitter tending toward parallel to the side
`of the skull wherethe lobesstill are fairly wide, and globular
`providing skull penetration. More importantly the db emit-
`ters are better in attracting, or repelling, other lobes back
`towards the brain, and determining the direction of lobes in
`the phased-array.
`The focusing of these arrays of magnetic lobes is useful
`in the practice of the present invention. As an example a
`cluster of 3-7 of the yy emitters will drive the primary
`magnetic lobes on one side of the head. The db emitters on
`the same side will help shape and stretch these primary
`lobes. The yy and db emitters on the other side of the head
`will shape and stretch the lobes to the preferred target areas
`in greatest concentration, hence phased-arrays.
`T'IG. 5 showsis a top view ofa patient wearing a TMScap
`ofthe present inventionthat contains db emitters 504 and yy
`emitters 505 but no ERG sensors. Orientation of the cap is
`seen by the patient’s nose 501 and ears 502, 503. The
`emitters 504, 505 are generally flat discs that are in the basic
`shape of a circle. The emitters are butted-up against one
`another, attached to the fabric mesh substrate, and vary in
`starting sequence and varyin position from row to row. The
`emitters 504, 505 are connected by wires (not shown) to a
`control panel (not shown) that contains the programmed 5
`software and power supply. Preferably,
`the emitters are
`arranged in an alternating configuration as depicted in FIG.
`5. The emitters 504, 505 are sewn on, or attached by other
`means, like buttons, over the whole cloth mesh fitted to
`cover a head and should not overlap. An average size cap
`will contain about 125 or more emitters. This TMS cap is
`used to administer repetitive TMSto a targeted area of the
`brain.
`FIG.6 is another top view of a patient wearing a TMS cap
`of the present invention that contains db emitters 604 and yy
`emitters 605 but no EEG sensors. Orientation of the cap is
`seen by the patient’s nose 601 and ears 602, 603. The
`emitters 604, 605 are generally flat discs that are in the basic
`shape of a circle. The emitters are butted-up against one
`another, attached to the fabric mesh substrate, and vary in
`starting sequence and varyin position from row to row. The
`emitters 504, 505 are connected by wires (not shown) to a
`
`40
`
`45
`
`60
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`65
`
`exception that less emitters are employed.
`The focusing of these arrays of magnetic lobes is useful
`in the practice of the present invention. As an example a
`cluster of 3-7 of the yy emitters will drive the primary
`magnetic lobes on oneside of the head. ‘he db emitters on
`the same side will help shape and stretch these primary
`lobes. The yy and db emitters on the other side of the head
`will shape and stretch the lobes to the preferred target areas
`in greatest concentration, hence phased-arrays.
`The rT'MSdevice of the present invention can deliver, for
`example, magnetic stimulation to the front and rear regions
`of the brain; the motor cortex and frontal cortex regions of
`the brain; or the lateral sides of the frontal lobe regionof the
`brain. Preferably, the coil configuration is synchronized to
`promote coherence and synchronousbehavior, such as EEG
`wave patterns, between multiple locations in the brain.
`The present rTMS device can be used to enhance or
`improve physiological functions and to treat neuropsychi-
`atric disorders or conditions. Physiological functions include
`concentration, sleep, alertness, memory, blood pressure,
`stress, libido, speech, motor function, physical performance,
`cognitive function,
`intelligence, height
`(Gin children) and
`weight. A neuropsychiatric condition or disorder includes
`Autism Spectrum Disorder (ASD), Alzheimer’s disease,
`ADHD,schizophrenia, anxiety, depression, coma, Parkin-
`son’s disease, substance abuse, bipolar disorder, a sleep
`disorder, an eating disorder, tinnitus, traumatic brain injury,
`post traumatic stress syndrome, and fibromyalgia.
`Ofparticular interest in practicing the present invention is
`an rTMSdevicethat is used to treat disorders that have poor
`coherence across different regions of the brain, such as, for
`example, Alzheimer’s disease, speech and language disor-
`ders, schizophrenia and depression, by providing a device
`that can treat 2 or more regions of the brain simultaneously.
`In one embodiment of the present invention an rI[MS
`device is configured to treat an Alzheimer’s patient by
`providing magnetic field stimulation to the front and rear
`portions of the brain. The patient is treated daily for 30
`minutes with 6 seconds of magnetic stimulation per minute.
`Tn another embodimentof the present invention an rTMS
`device is configured to treat a patient having a speech
`disorder by providing magnetic field stimulation to the
`motorcortex and the frontal cortex regions of the brain. The
`patient is treated daily for 30 minutes with 6 seconds of
`magnetic stimulation per minute.
`In a further embodimentof the present invention an rI[MS
`device is configured to treat a schizophrenic patient by
`providing magnetic field stimulation to the lateral sides of
`the frontal lobe of the brain. The patient is treated daily for
`30 minutes with 6 seconds of magnetic stimulation per
`minute.
`
`In another embodimentofthe present invention an r[MS
`device is configuredto treat a depressed patient by providing
`magnetic field stimulation to the lateral sides of the frontal
`lobe of the brain. The patient is treated daily for 30 minutes
`with 6 seconds of magnetic stimulation per minute.
`‘There are several examples of disorders that result in EEG
`activity being incoherent or asynchronous betweendifferent
`brain regions. In Alzheimer’s, activity between the front and
`rear portions of the brain tend to lack coherence. In speech
`and language disorders, the motor cortex is often asynchro-
`nous with the frontal cortex. In other disorders such as
`
`Schizophrenia or depression, there is often seen a lack of
`coherence between the lateral sides of the frontal lobe.
`
`

`

`US 10,350,427 B2
`
`7
`8
`(FFT) where the dominant frequencyis at 9.71 Hz. It can be
`The symptomsofthe disorder are reduced and improve-
`seen that the dominant frequency of 9.71 is missing in some
`ment in cognitive function is achieved by administering the
`frontal channels. The right side map displays the power
`present rTMS pulses to entrain the regions to act in concert
`distribution in a top-view topography. The treatmentis to
`and synchronously.
`convert the intrinsic frequency to a train of ‘lL pulses in a
`The pulses generated by the present r[IMS device to
`computerscriptfile to trigger the TMS pulse discharge. The
`ditferent regions of the brain are preferably synchronized
`stimulation area will be the bilateral frontal
`lobe at a
`together to promote coherenceacross the brain. The coils are
`frequency of 9.71. The rT™MStreatments started on a daily
`oriented ergonomically with a tilt designed to fit the scalp.
`basis for 30 minutes will pull up the 9.71 Hz in those missing
`The rTMSdevice can contain multiple coils oriented to treat
`channels by providing stimulation at an harmonic of one of
`different regions of the brain or a single coil could be
`the biological signals.
`stretched so that the focus of the magnetic field is spread out
`The present invention may be embodiedin other specific
`inaline over a wider area. One example would beto stretch
`forms without departing fromits spirit or essential charac-
`the coil so that it covers both lateral sides of the prefrontal
`teristics. The described embodimentsare to be considered in
`lobe. If desired, the coil could be made larger which will
`all respects onlyas illustrative and notrestrictive. The scope
`cause the magnetic field to be more dispersed.
`of the invention is, therefore, indicated by the appended
`FIG. 106 shows an elongated coil that spreads the mag-
`claimsrather than bythe foregoing description. All changes
`netic field underneath the coil to cover an area underneath
`which come within the meaning and range of equivalency of
`the coil when used to administer rTMSto a patient. 'IG. 10a
`the claims are to be embraced within their scope.
`is a traditional coil that does not cover the same area as the
`We claim:
`elongated coil. The coil shown in FIG. 104 can treat more
`than one area of the brain.
`
`20
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`25
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`40
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`45
`
`FIG. 7 shows multiple coils connected together, situated
`to stimulate separate regions of the brain simultaneously.
`FIG.8 showsa phased array of coils 801, intended to use
`phase differences in pulses to direct and target multiple
`regions of the brain. The coils are operated by a central
`processor 802 that can adjust the magnetic field produced by
`each coil. An on/off switch 803 is sued to turn off a particular
`coil if desired.
`An additional aspect of the present invention is a method
`of optimizing repetitive transcranial magnetic stimulation
`(rTMS)ofa patient by recording the patient’s whole head
`EEG; mapping the energy of the EEG at one or more
`frequencies to identify regions of incoherent or non-syn-
`chronous brain activity; and administering rTMS to the
`regions of the brain that are incoherent and. non-synchro-
`nous. Such an optimized process can include an rlMS
`device that has (a) 2 or more coils,
`(b) a single coil
`configured in such a way to deliver stimulation to distinct
`regions of the brain, or (c) a phased-array magnetic field
`emitting device capable of forming complex geometries and
`emission fields wherein the phased array modalities are
`leveraged to induce positional and temporal intensities. A
`preferred phased array is the rTMS cap described herein.
`With EEG mapping, areas of low energy are identified by
`measuring the energy of the FFG at the interested frequency
`across the brain employing well knownalgorithm selected
`from the group consisting of least squares, LORETA, and
`focal optimization. Areas of low energy canalso be identi-
`fied by measuring the Q-factor (width of the frequency plot)
`at the one or more frequencies used to map the energy of the
`EEG.
`
`FIG. 9 showsthe results of an EEG and brainwave map
`including the powerdistribution in a top view topographyon
`an individual before treatment with rTMS. The left panel
`showsthe signals in time domain and the middle panel the
`frequency domain following Fast Fourier Transformation
`
`1. A repetitive transcranial magnet stimulation (¢PTMS)
`device for treating a neuropsychiatric condition or to
`improve a physiological function, the rTMS device com-
`prising:
`a coil configuration that produces a magnetic field capable
`of delivering magnetic stimulation, at an rl!MS pulse
`frequency, to two or more regions of a brain of a patient
`fitted with the rTMS device,
`wherein the rTMS device is configured to analyze
`recorded signals from the patient and determine, based
`on the recoded signals, a harmonic or subharmonic of
`a non-EEG biological metric of the patient,
`wherein the rTMS pulse frequency is the harmonic or
`subharmonic of the non-EEG biological metric,
`wherein pulses generated by the coil configuration are
`synchronized and promote coherence and synchronous
`behavior between multiple locations in the brain,
`wherein the coil configuration comprises 2 or morecoils,
`and
`wherein each respective coil comprises an on/off switch.
`2. The rTMSdevice of claim 1, wherein a geometry of the
`coil configuration is a phased-array of magnetic field emit-
`ting devices, allowing complex geometries and emission
`fields.
`3. The rTMSdevice of claim 1, wherein the device is
`configured to deliver magnetic stimulation to the front and
`rear regions ofthe brain.
`4. The rTMS device of claim 1, wherein the device is
`configured to deliver magnetic stimulation to the motor
`cortex and frontal cortex regions of the brain.
`5. The rTMSdevice of claim 1, wherein the device is
`configured to deliver magnetic stimulation to the lateral
`sides of the frontal lobe region of the brain.
`6. The rTMS device of claim 1, further comprising a
`recording device for recording the recorded signals from the
`patient.
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