(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY(PCT)
`
`(19) World Intellectual Property Organization
`
`International Bureau
`12 September 2008 (12.09.2008)
`PCT
`
`(43) International Publication Date
`
`(10) International Publication Number
`WO 2008/109058 Al
`
`(51) International Patent Classification:
`AGIN 2/04 (2006.01)
`
`(21) International Application Number:
`PCT/US2008/002832
`
`AO,AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA,
`CH, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE,
`EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU,ID,
`IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC,
`LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN,
`MW, Mx, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH,
`(22) International Filing Date:=3 March 2008 (03.03.2008)
`PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM,SV,
`SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN,
`ZA, ZM, ZW.
`
`(25) Filing Language:
`
`English
`
`(26) Publication Language:
`
`Tnglish
`
`(30) Priority Data:
`60/904,330
`
`1 March 2007 (01.03.2007)
`
`US
`
`(71) Applicant and
`(72) Inventor: FINSTERWALD, P., Michael [US/US]; c/o
`Array Therapeutic, LLC., 15905 Greenway Hayden Loop,
`Suite 108, Scottsdale, AZ 85260 (US).
`
`(74) Agent: GRIECCI, John, A.; The Law Office Of John A.
`Griecci, 703 Pier Avenue, Suite B #657, Hermosa Beach,
`CA 90254 (US).
`
`(81) Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`
`(54) Titles MAGNETIC STIMULATOR
`
`(84) Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KL, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM,
`ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, ‘TJ, TM),
`European (AT, BE, BG, CH, CY, CZ, DE, DK,EE, ES, FI,
`TR, GB, GR, HR, HU,IL,IS, IT, LT, LU, LV, MC, MT, NL,
`NO,PL, PT, RO, SE, SI, SK, TR), OAPI (BE, BJ, CK, CG,
`CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG).
`
`Published:
`
`with international search report
`before the expiration of the time limit for amending the
`claims and to be republished in the event of receipt of
`amendments
`
`203
`
`
`
`FIG. 7
`
`201
`
`(57) Abstract: A portable device for the delivery of time-varying magnetic fields to a portion of a subject’s body. The device
`includes a stimulator incorporating a stimulator coil configured to gencrate the time-varying magnetic ficlds over a surface of the
`stimulator. It further has a rechargeable powersource and a portable signal generator to drive the stimulator. The stimulator includes
`planarspiral coils mounted ona flexible circuit, and the device can receive feedback to optimize performance. The device can be
`incorporated into footwear, headwear and other garments.
`
`
`
`2008/109058A.IINIMIAININAINATINMATMHAIMATAAA
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`WO 2008/109058
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`PCT/US2008/002832
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`MAGNETIC STIMULATOR
`
`This application claims the benefit of U.S. provisional Application No.
`[0001]
`60/904,330, filed March +, 2007, which is incorporated herein by reference for
`all purposes.
`
`The presentinvention relates generally to a medical deviceto treat a
`[0002]
`patient using magnetic stimulation, and, more particularly,
`to a portable,
`wearable device configured to apply time-varying magnetic waves to the
`patient’s anatomy, and to related methodsfor the treatment of a patient using
`low power, pulsed magnetic fields.
`
`10
`
`15
`
`20
`
`BACKGROUND OF THE INVENTION
`
`Polyneuropathy is a neurological condition in which nerve damage
`[0003]
`creates pain or numbness usually in the extremities. Diabetics commonly
`have this condition in
`the feet.
`Neuropathy may also be cause by
`chemotherapy, alcoholism, or other toxins in the body. Currently there is no
`knowncurefor this condition and there are limited pharmacological treatments
`available for the managementof associated pain.
`
`It has been reported that exposure of the feet to magnetic energy
`[0004]
`increases microcirculation and oxygenation, important factors in the treatment
`
`and maintenance of neuropathy in the feet. Accordingly, there has existed a
`need for a device that applies time varying magnetic fields to the feet, or other
`portions of the body, the device being low cost and easyto use in order for
`this therapy to be used as a home managementtreatment by a large patient
`population. Preferred embodiments of the present invention satisfy these and
`other needs, and provide further related advantages.
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`
`SUMMARYOF THE INVENTION
`
`[0005]
`In various embodiments, the present invention solves someorall of
`the needs mentioned above, providing a device that applies time varying
`magnetic fields to the feet, or other portions of the body, the device being low
`cost and easy to use in order for this therapy to be used as a home
`
`managementtreatment by a large patient population.
`
`A portable device underthe invention, for the delivery of time-varying
`[0006]
`magnetic fields to a portion of a subject’s body, may include a stimulator, a
`
`10
`
`rechargeable power source, and a_ The=stimulatorsignal generator.
`
`
`incorporates
`a stimulator
`coil configured to generate the time-varying
`magnetic fields, and defines a body-contact surface configured to conform to
`the portion of the subject’s body. The signal generator is configured to use
`power from the power source to drive a time-varying current through the
`flexible coil and thereby create the time-varying magnetic fields. Additionally,
`
`15
`
`the stimulator may be configured as a flexible body that can flex to better
`
`conform to the portion of the subject's body.
`
`[0007] Advantageously,
`
`the device is small, portable, and provides for
`
`stimulators to be widely used by subjects at a reasonable price. The closely
`
`conforming stimulator coils focus the available energy on the exact body
`
`20
`
`portion over which stimulation is desired, and thereby minimize both the
`unintended stimulation of other body portions, and the battery capacity (and
`therefore size) needed to support this portable unit.
`
`[0008]
`
`The stimulator coil may define a generally spiral conductor path
`
`This configuration
`surface.
`to the body-contact
`substantially parallel
`advantageously provides for the stimulator coil
`to be incorporated into a
`
`25
`
`membrane-shapedstimulator that can fit in small locations, such as the insole
`
`of a shoe.
`
`This configuration further allows for stimulator coils to be
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`concentrically stacked for increased field strength, and/or partially overlapped
`for a more even field strength distribution.
`
`The signal generator may include a controller configured with a
`[0009]
`memory that stores waveform information, providing the signal generator the
`ability to vary the type of waveform applied. The waveform information may
`be mathematical in form, allowing waveforms to be calculated from a minimum
`
`amount of information.
`
`The device may also be provided with a sensor configured to sense
`[0010]
`a responseto the time-varying magnetic fields by the subject’s body, and the
`signal generator may be configured to control the time-varying current based
`on sensed response.
`Thus, feedback can be used to control
`the field
`
`10
`
`strength, field distribution, stimulation time, and other related variables to
`
`producebetter stimulation results.
`
`the invention will become
`features and advantages of
`[0011] Other
`apparentfrom the following detailed description of the preferred embodiments,
`
`15
`
`taken with the accompanying drawings, whichillustrate, by way of example,
`the principles of the invention. The detailed description of particular preferred
`embodiments, as set out below to enable oneto build and use an embodiment
`of the invention, are not intended to limit the enumerated claims, but rather,
`
`20
`
`they are intended to serve as particular examplesof the claimed invention.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Figure 1 is a perspective view of an embodimentof a portable device
`[0012]
`for the delivery of time-varying magnetic fields to a portion of a subject's body.
`
`Figure 2 is a top plan view of a flexible printed circuit containing two
`[0013]
`spiral coils, as used in the embodimentdepictedin figure 1.
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`4
`
`[0014]
`
`Figure 3 is a system diagram of a driver, as used in the embodiment
`
`depicted in figure 1
`
`[0015]
`
`Figure 4 is a cross-sectional view of a flexible stimulator and a
`
`connector, as used in the embodiment depictedin figure 1, attached to an arm
`of a subject.
`
`[0016]
`
`Figure 5 is a variation of the embodiment depicted in figure 1.
`
`[0017]
`
`Figure 6 is an elevational cross-section view of the flexible printed
`
`circuit of Figure 2.
`
`
`
`[0018] an_elevational cross-section view of a secondFigure 7 is
`
`
`
`10
`
`embodimentof the invention.
`
`[0019]
`
`Figure 8.
`
`is an elevational cross-section view of a variation of the
`
`embodiment depicted in Figure 7.
`
`[0020]
`
`Figure 9 is a cross-section view of another variation of
`
`the
`
`embodiment depicted in figure 7.
`
`15
`
`[0021]
`
`Figure 10 is an elevational cross-section view of a third embodiment
`
`of the invention.
`
`[0022]
`
`Figure 11 is a top view of the embodiment depicted in figure 10.
`
`DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
`
`[0023]
`
`The invention summarized above and defined by the enumerated
`
`20
`
`claims may be better understood by referring to the following detailed
`
`description, which should be read with the accompanying drawings. This
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`
`detailed description of particular preferred embodiments of the invention, set
`
`out below to enable one to build and use particular implementations of the
`
`invention,
`is not intended to limit the enumerated claims, but rather,
`intended to provide particular examples of them.
`
`it
`
`is
`
`A meansis provided for the application of time varying magnetic
`[0024]
`fields to a portion of a subject's body, such as a foot. The device can be
`relatively low cost, and can be easyto use portably or in the subject’s home.
`Typical embodiments of the present invention reside in a portable device that
`
`can conform to various portions of the body.
`
`In use, the device is applied to a specific portion of the subject’s
`[0025]
`body, for example, the soles of the feet. The body portion is then exposed to
`a dynamic magnetic flux generated by the device for a desired exposure time
`(e.g., on the order of 30 minutes per day). The exposure time, magnetic flux
`density and frequency spectrum of the magnetic wave are selected to
`
`optimize the desired effects on the body portion (e.g., the reduction of pain in
`numbnessin that portion of the body). Other body portions to be subjected to
`stimulation could include the legs, arms, hands or head.
`
`[0026] With reference to FIGS. 1-3, a portable device for the delivery of
`desired time-varying magnetic fields to a portion of a subject's body includes a
`stimulator in the form of a flexible body 101. Theflexible body is attached by
`a cable 103 to a driver 105. The flexible body incorporates a flexible circuit
`
`111 that includes two stimulator coils in the form of flexible coils 113 that do
`
`not overlap. The driver includes a rechargeable power source 121 such as a
`high capacity lithium battery, and a signal generator 123 that are structurally
`interconnected (i.e., structurally held in one position retative to one another) by
`a driver body 125. The signal generator 123 is configured to use power from
`the power source 121 to drive a time-varying current through the two flexible
`
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`coils 113 via the cable 103, which electrically interconnects (i.e., puts in
`electric communication) the flexible coils and the signal generator.
`
`The flexible coils 113 are configured to generate the desired time-
`[0027]
`varying magnetic fields, and the flexible body 101 is configured to be in close
`proximity with, and conformingly received against, the portion of the subject's
`body so as to allow for magnetic fields from the coils to stimulate the body
`portion with a minimum of wasted energy.
`
`10
`
`15
`
`the
`To provide for the flexible body 101 to be highly adaptable,
`[0028]
`flexible body is preferably a flexible membrane defining a body-contact
`surface, and characterized by a thickness (along a dimension normal to the
`body-contact surface) that is substantially smaller than its length and width.
`The thickness may be constant over the area of the surface, or may vary
`through a range of values that are all substantially smaller then the length or
`width. Because the flexible membraneis flexible,
`it can assume a variety of
`shapes, such as a planar shape anda rolled shape, and such as the various
`
`shapes formed by the various surfaces of a subject’s body. This, the flexible
`
`body is configured to flex such that the body-contact surface conforms to the
`
`It should be noted that the phrase “body-contact
`portion of the subject's body.
`surface” should not be understood to require direct contact with the subject's
`
`20
`
`body. For example, the invention envisions that a sanitary drape could be
`
`interposed betweenthe stimulator body-contact surface during use.
`
`To accommodate both the desired level of flexibility and a desire for
`[0029]
`the device to be easily cleaned, the flexible body could be made from an
`appropriate material, such as silicone rubber. Theflexible circuit 111 may be
`embedded within the flexible body, close to and extending parallel with the
`
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`
`body-contact surface.
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`
`the stimulator body-contact surface,
`In an alternative variation,
`[0030]
`without substantial deformation, may be designed to conform to the portion of
`the subject's body to be simulated. The stimulator may then be configured
`either as rigid, or as partially pliable,
`that
`is, pliable only to the extent
`necessary to accommodate shape changes that may occur as the portion of
`
`the subject's body moves.
`
`10
`
`[0031] With reference to FIG. 4, the device mayfurther include one or more
`
`connecters 131 configured to hold the flexible body 101 with respect to the
`subject's body such that the flexible coil is conformingly received adjacent a
`surface 133 of the relevant portion of the subject's body. The connectors
`could be in the form of an adhesive, an adjustable strap, an elastic strap, a
`bandage, clothing, or other such devices for conforming and connecting the
`flexible membrane to a body. The driver may be carried by hand, or can be
`attached to and worn elsewhere on the subject's body.
`
`15
`
`[0032] With reference to FIG. 5,
`
`in one variation of this embodiment the
`
`flexible body 101 and the driver 105 (and therefore the rechargeable power
`
`source and signal generator) are structurally interconnected.
`
`In the context of
`
`this
`
`application,
`
`it
`
`should be understood that
`
`the
`
`term structurally
`
`20
`
`interconnected (with respect to two items) is defined to mean structurally held
`in one position relative to one another, and capable of structurally supporting
`one another.
`|
`
`the flexible body may be
`[0033] Under one example of this variation,
`strapped to a subject's body portion (e.g., an arm, a hand or the sole of a
`
`foot), with the driverrigidly attached to a connecting portion 141 of the flexible
`
`25
`
`body. The attachment may be detachable, such as bya clip that readily clips
`
`onto a mating receptacle.
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`
`the attachment may be
`Under another example of this variation,
`[0034]
`integral. The signal generator, rechargeable battery and flexible printed circuit
`coil may be laminated within the flexible body, which can then be worn on the
`subject’s body portion. As with the prior example,
`this integrated portable
`magnetic stimulator can be placed on the body, for example on the head, and
`attached by means of an adjustable strap, bandage, clothing, or the like. An
`advantage of both examplesofthis variation is that they can be made without
`a cable, thereby simplifying the magnetic stimulator for a user.
`
`10
`
`it should be understood that the
`In the context of this application,
`[0035]
`term integral implies a connection that either cannot be detached, or can be
`detached only by a disassembly process that would not frequently be
`attempted by a subject using the device.
`It should also be understood that the
`
`term detachable attachment implies a connection that is not integral.
`
`[0036] With reference to FIGS. 2 and 6, each flexible coil 113 is a flat
`
`15
`
`magnetic coil on a flexible printed circuit 111 containing one or morespiral flat
`coil conductive layers. The flexible coil defines a generally spiral conductor
`
`path substantially parallel to the body-contact surface of the flexible body. An
`
`advantageof using a flexible printed circuit flat coil is ease of manufacture and
`
`low cost combined with durability and flexibility of the coil when worn in a
`
`20
`
`structurally challenging environment, such as a shoe.
`
`As an example, each flexible circuit 111 might be constructed with a
`[0037]
`1 oz. copper thickness, and form two spiral
`flat coils that are each
`approximately 1.5 in x 2.5 in. in area. Each of these spiral coils may have 70
`turns with a 6 mil trace width and a 4 mil space between traces 151. An inside
`
`25
`
`end of each coil connects via a through hole 153 to an opposite surface of the
`flexible circuit, on which that end can extend backto electrically connect to the
`signal generator. The individual spiral coils are electrically isolated from each
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`other and have separate leads 155 for connection to the signal generator.
`The electrical resistance of each individual coil is approximately 30 ohms.
`
`A magnetic wave with spectral frequency range less than 20 kHz
`[0038]
`might be generated using the signal generator 123 to drive the flexible coils at
`less than 10 Gauss RMS (average) power of magnetic flux over the area to be
`stimulated. The magnetic wave maybebipolar (alternating between positive
`and negative flux) or unipolar (alternating between O and either a positive or
`
`negative value).
`
`flat magnetic stimulator coils may be included on the
`[0039] Additional
`flexible printed circuit. The additional stimulator coils are also driven by the
`signal generator using power
`from the power source.
`The additional
`
`stimulator coils may at least partially overlap the first and/or second stimulator
`
`coils to provide for increased local magnetic field strength and/or a more even
`distribution of magnetic field strength. Optionally, such stimulator coils may be
`made concentric to increase local magnetic field strength.
`
`10
`
`15
`
`[0040]_In a variation of the embodiment, the flexible coil may be a finely
`woundwire coil having widings that extend around and along an axis running
`substantially normal to the body-contact surface. Multiple finely wound wire
`coils could be distributed across the body-contact surface area, and be
`
`20
`
`25
`
`connected in series or parallel as required to match electrically to the signal
`generator. Other coil configurations are also considered within the scope of
`the invention.
`
`through the
`time-varying current
`The signal generator drives
`[0041]
`stimulator coils to deliver time-varying magnetic fields to the portion of the
`subject's body. The signal generator may include a timer circuit that switches
`
`the battery current on and off through a Darlington pair arrangement of
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`
`transistors to the printed circuit coil at varying levels. The delivery of a wide
`variety of time-varying magnetic wavesis within the scopeof the invention.
`
`For example, one possibility under the present invention is the use of
`[0042]
`a unipolar magnetic wave with frequency of 500 Hz is used and a peak
`instantaneousflux density of between 0.5 and 8 Gauss (0 to peak) and a DC
`flux level of between 1 and 5 gauss. Alternatively the driving waveform maybe
`AC with a peak instantaneousflux density of between 1 and 16 Gauss (peak
`to peak) and a DCflux level of approximately 0. The driving signal (output of
`the signal generator) may substantially be a square wave at 500 Hz. Thesize
`(area) of the coil may be approximately 7.5 in?, and the stimulation time might
`be between 30 minutes and 3 hours.
`
`the magnetic stimulation may be pulsed.
`In another possibility,
`[0043]
`Pulses may be delivered by a tone-burst in which a fixed numberof cycles of
`a sinusoidal, square, or triangular wave are transmitted, followed by a period
`of no transmission, and then repeated. The tone burst frequency might vary
`between 6 and 22 Hz and the numberof cycles between 2 and 8.
`For
`examplea single pulse, or tone-burst, can be made bytransmitting 4 cycles of
`a 14 Hz sine wave. The period of the tone-burst, or the time between pulses,
`is then varied for example between 0.6 seconds and 2 seconds. By varying
`the tone burst frequency, the number of cycles transmitted, and the period
`(time between bursts) during the application the magnetic stimulation might be
`made to be more compatible with the body, as opposed to using a fixed
`frequency and fixed period of stimulation. The stimulus can be made to
`
`approximate a Poisson distribution,
`
`a Gaussian distribution, or other
`
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`
`20
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`25
`
`continuous distribution function.
`
`the signal
`in yet another possibility,
`[0044] With reference to FIG. 3,
`generator may include a controller 161 configured to access a rewritable
`memory 163. The memory stores waveform information, and the signal
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`
`the time-varying current based on the
`generator is configured to control
`waveform information stored in the memory. As a result, the signal generator
`may be configured to provide a variety of different
`types of magnetic
`stimulation, and it might further be configured to have the types of magnetic
`stimulation changed or upgraded using an external communication port.
`
`10
`
`15
`
`be mathematical
`the waveform information may
`Optionally,
`[0045]
`information from which a waveform can be calculated. The signal generator
`would be configured to control the time-varying current based on calculations
`using the waveform information stored in the memory. As a result,
`the
`quantity of waveform information needing to be stored, read and/or input might
`be significantly reduced.
`
`[0046] With reference to FIG. 4, the device can further include a: sensor
`
`configured to sense a response to the time-varying magnetic fields by the
`subject's body. The signal generator may then be configured to control the
`time-varying current based on sensed response, such as with a feedback
`circuit configured to guide the body's response to a desired response level.
`Furthermore, In the case where multiple coils are used, one or more sensors
`
`can be usedto tailor stimulation levels over a given area to better achieve a
`desired result.
`
`20
`
`[0047] Depending on which part of the subject body is to be stimulated,
`
`if the soul of the
`various types of sensors might be used. For example,
`subject's foot is to be stimulated, the sensor might be pulse oximeter, which
`would be useful for sensing blood oxygenlevels. Likewise, if a subject head is
`to be stimulated, the sensor might be an electroencephalograph electrode,
`which would be appropriate for sensing brain waveactivity.
`
`25
`
`[0048] Optionally, an MP3 portable audio player such as iPod Shuffle ® (or
`other such portable audio player) may be used as the driver. Under this
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`
`variation, an audio amplifier serves as the signal generator, and is integrated
`with a rechargeable battery, a memory, and a controller configured to
`selectively use waveform information read from the memory to drive a time-
`varying current for use by the stimulator.
`
`[0049] Advantageously, the use of such devices would provide a familiar,
`user-friendly interface for a subject, who may already have compatible battery
`chargers and other accessories. Additionally, the infrastructure for providing
`subjects with updated waveform information (such as over the Internet) is well
`developed and commercially available. Also, such devices are designed for
`uniform output poweroverthelife of the battery, while being of low cost and
`small size.
`
`10
`
`[0050]_In.use, it is anticipated that the a 10 minute stereo MP3file would be
`
`generated for a sine wave at 500 Hz (on each channel). The MP3file would
`be downloaded to the MP3 player using existing resources such as the Apple
`iTunes ® software. The MP3 player would be turned on and the volume
`
`15
`
`settings set to maximum. Such settings should provide consistent levels of
`
`stimulation from one use to the next. The battery life of the MP3 playeris
`anticipated to be approximately four to five hours in the above described
`
`configuration based on existing MP3 players, and would have changeable /
`upgradable stimulation programming.
`
`20
`
`[0051] Alternatively, other audio range signal generators are within the
`scope of the invention.
`It should be noted that the use of a portable audio
`player to drive two separate coils, each coil being driven by a separate
`channel of the audio player, provides for more efficient use of the limited
`
`25
`
`power available on each channel of a given portable audio player. Thus, by
`using both channels on maximum power, concentrically placed coils can
`achieve higher levels of stimulation than might otherwise be achieved using
`the portable audio player. Likewise, by using both channels on maximum
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`
`power, overlapping but not concentrically placed coils can achieve a wider
`area of stimulation than might otherwise be achieved using the portable audio
`
`player. Moreover, the portable audio player may control the separate channel
`
`signals to tailor the levels of stimulation given to separate (though typically
`
`close) portions of the body.
`
`[0052] With reference to Fig. 7, another embodiment of a portable device
`
`for the delivery of desired time-varying magnetic fields may be specifically
`
`configured for use with a subject's foot (and particularly the sole of the foot)
`
`while the person is mobile.
`
`In this case, the operating environment is very
`
`10
`
`challenging, as the sole of a foot carries the entire body weight, and mustflex
`
`while walking.
`
`In this application, a person is understood to be mobile if they
`
`are free of any tether, such as a powercord, andif they are not encumbered
`
`by any devices that would significantly limit their ability to transport themselves
`
`by their conventional means (e.g., by walking).
`
`15
`
`[0053]
`
`This embodiment includes a stimulator in the form of a flexible body
`
`201. The flexible body is attached by a cable 203 to a driver 205. As before,
`
`the flexible body incorporates a flexible circuit 211 that includes two stimulator
`
`coils in the form of flexible coils that do not overlap. Similarly this driver also
`
`includes a rechargeable power source such as a battery, and a signal
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`20
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`generator that are structurally interconnected by a driver body. The signal
`
`generator is configured to use power from the power sourceto drive a time-
`
`varying current through the two flexible coils via the cable, which electrically
`
`interconnects the flexible coils and the signal generator.
`
`This embodiment provides an item of footwear that incorporates the
`[0054]
`stimulator. More particularly,
`the item of footwear includes a substantially
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`25
`
`typical shoe upper 271 and a typical shoe outsole 273. The integrated upper
`
`and outsole form a structural element configured to receive the subject's foot.
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`In this case, the stimulator is an integral insole that incorporates the flexible
`circuit and is structurally interconnected to the structural element.
`
`is noteworthy that the footwear is not simply a limited orthotic
`It
`[0055]
`device. The outsole extends across the entire bottom of the foot, providing
`protection from the ground in the form of a portable surface to walk upon.
`Moreover, the outsole is flexible enough to allow for the flexing of a foot while
`walking.
`
`[0056] As before, the stimulator has a body-contact surface configured to
`conform to the portion of the foot to be stimulated. The structural element is
`
`configured to conformingly hold the stimulator with respect to the subject's foot
`such that the stimulator coil is conformingly received adjacent the portion of
`the subject's foot to be stimulated.
`It is further configured to maintain the
`stimulator in this position while the subject is walking, despite the changing
`shapeof the subject’s foot that occurs.
`
`Optionally, the stimulator may be a flexible body configured to flex
`[0057]
`such that the body-contact surface conforms to the portion of the subject
`body. Alternatively, the body-contact surface, without substantial deformation,
`
`may be designed to conform to the foot. The stimulator may then be
`configured either as rigid, or as partially pliable, that is, pliable only to the
`extent necessary to accommodate shape changes that may occur as the
`portion of the subject's body moves.
`Therigid and partially pliable options
`may be particularly useful when the stimulator is used on body portions that
`may require support (e.g., when the stimulator is incorporated into an insole).
`
`10
`
`15
`
`20
`
`[0058]
`
`The structural element upper typically will be in the form of a shoe
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`25
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`upper, protecting and covering most or all of the foot.
`
`To conceal
`
`the
`
`presenceof the device, the structural element may appear asa typical shoe.
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`[0059]
`
`The item of footwear may be a completely custom-designed item, or
`
`it may be a commercially available item which has hadits insole removed and
`
`replaced with an insole having a stimulatorcoil.
`
`in this embodiment the integrated driver,
`[0060] As depicted in FIG. 7,
`including the signal generator and the rechargeable power source, are
`
`structurally interconnected to the structural element (e.g., on the upper). The
`
`connection may be detachable from the structural element, such as using a
`clip that readily clips onto a mating receptacle, or the connection may be
`integral.
`
`10
`
`[0061]
`The structural element may form a heel. As depicted in FIG. 8, ina
`variation of this embodiment,
`the integrated driver,
`including the signal
`generator and the rechargeable power source, are incorporated into the heel,
`
`and are thus integral with the item of footwear.
`
`[0062] While it is apparent from the figures that the item of footwear can be
`a shoe, a slipper, a boot or the like,
`it should be noted that numerous other
`
`15
`
`variations exist.
`
`In a distantly related embodiment, the structural element
`
`could also be a sock on which a stimulator is mounted (as depicted in FIG. 9).
`
`20
`
`25
`
`[0063] While the above described items of footwear are custom items, such
`as a shoe having its integral insole removed and a stimulator insole integrally
`attached, other embodiments may be designed as inserts to be placed within
`
`the structural element may consist
`For example,
`standard footwear.
`essentially of an insole that incorporates a rechargeable power source, a
`
`signal generator, a cable and a flexible circuit with its stimulator coil, as
`
`depicted in FIGS. 10 and 11.
`In these figures, it can be seen that the insole
`includes a flexible circuit 301, a structural element 303, a battery 305, a signal
`generator 307, and a connector 309 through which the device may be
`connected to a power source and/or a data source.
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`Asin the previous embodiments, the driver could be an audio signal
`[0064]
`generator such as an MP3 audio player, but it should be recognized that
`significant size limitations exist for the driver in this embodiment.
`
`The invention further includes a method for delivering time-varying
`[0065]
`magnetic fields to a portion of a subject's body using various embodiments of
`the portable device, as described above. The method includes the step of
`mounting the stimulator on the portion of the subject's body such thatit can be
`carried on the subjects body. For embodiments that are wearable articles,
`such as a shoe, a hat, a scarf, or other garment incorporating a stimulator, this
`step involves donning the article. For embodiments that must be separately
`attached, the step involves placing the stimulator against the portion of the
`subject's body, and attaching it
`there using an appropriate connector or
`fastener.
`
`The method further includes the step of electrically interconnecting
`[0066]
`the stimulator coil, the signal generator and the rechargeable powersource.
`Depending on the form of connection, this step may entail connecting one or
`more wires between the components, orit could entail establishing a wireless
`connection between one or more of the components, should the system be so
`designed.
`The method also includes the step of activating the signal
`generator to use powerfrom the powersourceto drive a time-varying current
`thr