(12‘; ENTERNATEONAL APPLICATION FUBMSHED UNDER THE 'A’E‘EN'E” COOPERATION TREATY Will”)
`
`(19) Werid Intellectual Property Organization
`internatienal Bureau
`
`(43) International Publication Date
`12 Seytember 2am; (12.99.2993;
`
`(51)
`
`international Patent Classification:
`AWN 2/6’4 (2006.01)
`
`
`
`
`
`(10) international ii‘tibiieation, Number
`
`WQ zeeaiieeegs At
`
`
`AO, AT, AU, AZ BA, BB, BG, BH, BR. BW, BY, BZ CA,
`CH, "N, CO, CR, CEL CZ, DE, DK, DM, DO, DZ, EC, HE,
`E 1', ES, FT, GB, GD. GE. Gil, GM, CIT, HN, HR, HU, ID,
`1L, IN, 13, H), KE, KG, KM, KN, KP KR, KZ, LA, LC,
`LK, LR, LS, LT, LU,
`.Y, MA, MD, ME, MG, MK, NW,
`"r‘l‘
`’
`r’ m“:
`',V i
`)‘)
`g???égiégvgfilfSEQ/:égxf‘éaifijgé(33:? :13: 15%,:
`33', TJ, TM TN, TR, TT, TZ UA, UG, US, UZ, VC, VN,
`ZA, ZMI, ZW.
`
`('84) Designated States (unless otherwise indicated. for every
`kind of regional protection available); ARIPO (BW, GH,
`G54, KE, LS, mow? iVTZ, LEA: SD, 5L: SZ, TZ, UG, ZiVi,
`
`"uropearmfl, ’,”i,l,",l’, .3,,",w’i,33,*,
`m2, GB, GR, HR, HU, EE. 13, ET, LT, LU. LV. MC, MT. N1,
`NO, PL,P’1‘,RO,SE, SI, SK, TR), OAI’l (BF, BJ, CF, CG,
`CI, CM, GA, GN. GQ, GW, ML, MR, NE, SN, TD, T0).
`
`Pubiished:
`_ with imematinnal search report
`"""
`Eeyore the expiration of the time iimizfiv amending the
`eiaims and to be republished in the event of receipt of
`amendments
`
`('21) Intifriizitinnai Appiicaiion Number:
`PCT/U52008/003832
`3 March 2008 (03.032008)
`Engmh
`
`international Filing Date:
`(22.)
`(25> Wing Language:
`
`(26) Publication Language;
`
`English
`
`(30) Priority Data:
`fiO/‘i‘iMfiSli
`
`i
`
`i‘viarci’i 23307 (01.03.2007)
`
`US
`
`‘,..
`Ta
`.
`6‘
`,T, T,‘
`(’2‘) itiiijii);:ITZTFTTEVAiEiOEGY‘f:::d “11:13] 1:)”
`2; f) ,1 (,8 '5‘“: 52" 7’, kg, U,‘
`3
`‘1 ”
`1”
`‘ “1‘“:
`‘ ”“0"“ as A" 2“ "O” l
`‘3'"
`(74) Agent: (SIREECCE, John, A.; The Law Office Of John A.
`Griecci, 703 Pier Avenue, Seize B #657, Hermosa Beach,
`CA 90234 (US),
`
`(31') Designated States (unless ozizenuise indicated, for every
`kiwi 0f natinmu’ prnleelinn available}: AE, AG, AL, AM,
`
`{54) Title: MAGNETIC STTMIHIATOR
`
`283
`
`
`
`PEG. '2’
`
`20‘?
`
`(57) Abstract: A portable device fer the delivery of timevarying magnetic fields: to a portion of a subject’s: body. The device
`includes a stimulator incorporating a stimulator cell configured to generate the time-varying magnetic fields over a surface of the
`stimuia‘tor. It further has
`rechargeable power source and a peltahie signal generator to drive the stimulator. The stimulator includes
`planar spiral coils mounted on a flexible circuit, and the device can receive feedback to eptimize pertttnimance. The device can be
`ihcmporaterl into footwear, headwear and other garmentg.
`
`
`
`wezeeeiteeeeeAtIIEEIEEIIIEEEIIIEIEI
`
`

`

`‘WO 26(38/109058
`
`PCT/U SZiititi/titi2832
`
`MAGNETiC STEMULATGR
`
`{OOO‘t}
`
`This appiication eieims the benefit at US. previsionai Appiieatien hie.
`
`69/904,330, tiiect March ”i, 2907, which is ineerperated herein by reference for
`
`aii pnreeses.
`
`$3962]
`
`The present inventien reiates generaiiv to a medieai cteviee te treat a
`
`patient using magnetic stimaietien, and, more partieuiariy,
`
`to a pertahiei
`
`wearahie device oentigurert
`
`te apeiy timenverying magnetic waves tn the
`
`patient‘s anatemy, and in reiateci metheds for the treatment at a patient using
`
`ievv power, euised magnetic: tieicis.
`
`if)
`
`BACKGRQUND (3F THE iNVENTiON
`
`[0003}
`
`Peivneerepethy is a neureiegioai eenditien in which nerve damage
`
`creates pain er numbness usuaiiy in the extremities. Diabetics commeniy
`
`have this eenriitien in
`
`the feet.
`
`Neuropathy may aise be cause by
`
`chemotherapy, aieehoiism, er ether toxins in the body. Cnrrentiy there is no
`
`15
`
`known cure for this centtitien and there are iimiteci pharmaeeiegieai treatments
`
`aveiiabie fer the management at associated pain.
`
`{@604}
`
`it has been repented that exposure of the feet te magnetic energy
`
`increases miereeireuiatien and oxygenatien, important factors in the treatment
`
`and maintenance at neurepathy in the feet. Accordingiy, there has existed a
`
`2C}
`
`need ter a device that apprise time varying magnetic tietds to the feet, er ether
`
`pertiens of the batty, the device being iew cast and easy te use in order for
`
`this therapy te he used as a heme management treatment by a iarge patient
`
`popuiation. Preferred emhediments of the present invention satisfy these and
`
`ether needs, and previee farther reiateri advantages.
`
`

`

`‘WO 2338/109058
`
`PCT/USZGtiS/ttfi2832
`
`SUMMARY {35: THE ENVENTEGN
`
`{0805}
`
`in various embodiments, the present invention soives some or eii of
`
`the needs mentioned above, providing a device that eppiies time varying
`
`magnetic tieids to the feet, or other portions of the body? the device being tow
`
`cost and easy to use in order for this therapy to he used ee at home
`
`management treatment by e iarge patient popuietion.
`
`{@006}
`
`A portahie device under the invention, for the deiivery ot timenverying
`
`magnetic tieide to a portion of e subject’s body, may inciude e stimuietor, e
`
`rechargeehie power
`
`source, and a signei generator.
`
`The stimuiator
`
`10
`
`incorporates a stimuietor
`
`coii configured to generate the timewverying
`
`magnetic tieids, and defines a potty—contact surface configured to conform to
`
`the portion of the subject’s body. The signei generator is configured to use
`
`power from the power source to drive e timemverying current through the
`
`fiexihte coii and thereby create the timemverying magnetic tieide. Additioneiiy,
`
`the etimuietor may be configured as e tiexihie body that can iiex to better
`
`conform to the portion of the subject’s body.
`
`{330?} Adventegeousiy,
`
`the device ie em'eii, portaoie, end providee tor
`
`stimuiators to he wideiy used by subjects at e reesonahte price. The ctosety
`
`conforming stimuiater coiie focus the evaiiehie energy on the exact body
`
`2t)
`
`portion over which stimuietion is desired, and thereby minimize teeth the
`
`unintended stirnuietion of other body portions, and the battery/capacity (and
`
`therefore size} needed to support this portehie unit.
`
`{titled}
`
`The stimuietor coii may define e genereiiy spirai conductor peth
`
`substantiaiiy pereiiei
`
`to the hodyucontect eurtece.
`
`This
`
`configuration
`
`25
`
`adventegeousiy provides for the stimuietor coii
`
`to be incorporated into a
`
`memhreneueheped stimuietor that can tit in srneii iocetions, such as the insoie
`
`of e shoe,
`
`This configuration further etiows tor stimuietor coiis to he
`
`

`

`‘WO wee/109058
`
`.
`
`3
`
`FCTI'USZGBBI’OQZBBZ
`
`concentrieaiiy stacked for increased iieid strength, and/or naniaiiy everiepped
`
`tor a mere even tieid strength distribution.
`
`[0039}
`
`The signai generatermey ineiude e centroiier configured with a
`
`memory that stares waveterm intermatien, providing the eignai generater the
`
`ahiiity he vary the type at waveform appiied. The waveform intermatien may
`
`he mathematieai in term, aiiewing waveterrne to he oaiduieted from a minimum
`
`ameunt et’ intermetien.
`
`{(3910}
`
`The device may arise he previded with a eeneer eentigured te sense
`
`a respense tn the timeuvarying magnetic tieids by the subject’s body, and the
`
`it)
`
`eignai generator may be configured to eentroi the timeovarying current based
`
`on sensed response.
`
`Thus, feedback can he need to eontroi
`
`the tieid
`
`strength,
`
`tieid distribution, etirnuiatien time, and other reiated variehtes to
`
`produce better etimuiation reeuite.
`
`[931 it Other features and advantages of
`
`the invention wiii become
`
`15
`
`apparent tram the tniiowing detaiied deeorietien at the preferred embedimente,
`
`taken with the accompanying drawings, which iiiuetrate, by way at examnie,
`
`the principies at the invention. The detaiied deeoription at partieuiar ereierred
`
`embodiments, as set out heiow tn enahie ene tn huitd and use an embediment
`
`at the inventidn, are not intended tn iimit the enumerated eiaime, hut rather,
`
`20
`
`they are intended ta serve as nartiouiar exampiee oi the eieimed inventien.
`
`BREEF DESCRBPTiQN Gt: THE DRAWENGS
`
`EGOtZi
`
`Figure 1 is a perspective view of an embodiment at a nertahie device
`
`for the deiivery at timeuvarying magnetic: tietds in a nertien at a subject's body.
`
`{OMB}
`
`Figure 2 is a ten nian view at a tiexihte printed circuit eenteining two
`
`25
`
`entrat eoiie, as need in the embodiment depicted in figure 1.
`
`

`

`‘WO 2338/109058
`
`PCT/[i52003/0i32832
`
`4
`
`{9014}
`
`Figure 3 is a eyetem diagram of a driver, as used in the embodiment
`
`depicted in figure “i
`
`{9015]
`
`Figure 4 ie a cross—eecticnei View of e iiexioie etimuieter and e
`
`ccnnecter, as used in the embodiment depicted in figure ”i, attached to an arm
`
`of e euhiect.
`
`{(3016}
`
`Figure 5 ie a variation et the embodiment depicted in figure in
`
`{0917]
`
`Figure 6 ie an eievationei croeeweectien View et the tiexioie printed
`
`circuit (it Figure 2.
`
`[9318}
`
`Figure 7 ie an eieveticnei
`
`cressmeeotion View of e second
`
`10
`
`embodiment of the invention.
`
`{@6193
`
`Figure 8.
`
`ie an eievationai creeeeeoticn View of a variation at the
`
`embodiment depicted in Figure "r”.
`
`[Q6203
`
`Figure 9 is e croeeueecticn View of enether variation of
`
`the
`
`embodiment depicted in figure 7.,
`
`15
`
`[0921}
`
`Figure it} is en eievatienai credeneection View et a third embcdiment
`
`of the invention.
`
`[9922]
`
`Figure it is e tee View otthe embodiment depicted in figure it}.
`
`{DETAILED DESCREETiON OF THE PREFERRED EMEQDEMENTS
`
`[60233
`
`The invention summarized ehove and defined try the enumerated
`
`20
`
`ciairne may he better understood try referring to the ieiicwing deteiied
`
`description, which ehouid be read with the accompanying drawings“ This
`
`

`

`"W0 239811090358
`
`PC7E‘/US20(D8/€i92832
`
`5
`
`detaiied descrintien e‘i particuiar preferred emhadirnente oi the invention, set
`
`out heiuvv te enahie ene to hutid and uee partieutar impiernentatiene hi the
`
`invention,
`
`is not
`
`intended te tintit the enumerated eiaims, but rather,
`
`it
`
`is
`
`intended it) provide particuiar examniee at them.
`
`{0924}
`
`A means is previded tar the apaticatien at time varying magnetic
`
`tietds to a portion at a Subjects hudy, such as a toot The device can he
`
`reiattveiy tow cast, and can he easy ta use pertehty er in the euhiect’e home.
`
`Typicai embodiments et the present invention reside in a pertahie device that
`
`can eunterrn tn varieue nertiene of the eddy:
`
`it}
`
`[3025}
`
`in use, the device is appiied to a specific nertien oi the subject’s
`
`hodys fer examnie, the sates at the feet. "the hedy portion is then expeeed to
`
`a dynamic magnetic flux generated by the device ter a desired exposure tirne
`
`(age, on the erder of 3d rninutes per day). The exposure tirne, magnetic flux
`
`density and frequency epectrurn at the magnetic wave are eeiected to
`
`15
`
`uptirnize the desired e‘iteete on the hedy eertien (erg, the reductien ei pain in
`
`numbness in that pertien at the eddy), Other hddy pertiens he he subjected to
`
`etirnutation coutd ineiude the tags, arrne, hands er head,
`
`[G926] With reference ta FEGSE tufts a pertahie device ter the deiivery at
`
`deeired tintemvarying magnetic tieids to a portion of a subject‘s hedy inciudes a
`
`2C)
`
`etimuiator in the term at a itexibte hedy tut; The tiexihie eddy ie attached by:
`
`a cahie 103 te a driver 105. The tiexihte body inedrperates a tiexihie circuit
`
`111 that inotudes twe etimuiater cutie in the form at tiexihte ceiis t‘tit that do
`
`net overiap. The driver ineiudee a rechargeahie newer seurce 121 such as a
`
`high capacity itthiurn battery, and a eignai generator t23 that are etructuratiy
`
`25
`
`interconnected (ire, etrueturetiy heid in One pesitien reiative te ene another) by
`
`a driver body 125, The Signet generater t23 ie centigured in use newer trern
`
`the pewer eeuree “i221 te drive a timewvarying current through the twe tiexihie
`
`

`

`Vii/'0 ZQQS/IGQQSE
`
`PCTIUSZOQS/092832
`
`6
`
`edits tt3 via the cahie 1&3? which eieetrieaiiy intersennects (is, nuts in
`
`eiestrie communication) the tiexihie edits and the signei generator.
`
`{002?}
`
`The tiexihie soiis 113 are configured to generate the desired time
`
`varying magnetic tieids, and the hexihie body 101 is seniigured to he in ciese
`
`oreximiiy with, and soniorrningiy received against, the onrtien of the subject’s
`
`body so as to aiiow for magnetic tieids from the ooiis to stimuiate the body
`
`aertion with a minimum of wasted energy.
`
`{09283
`
`"in previde for the hexihie eddy tut
`
`ta he highiy‘adantahie,
`
`the
`
`tiexihie body is preterahiy a tiexihie membrane defining a bedyucontast
`
`10
`
`surface, and characterized by a thickness (atong a dimension normai to the
`
`hody~centast suriase) that is substantiaiiy smaiier than its iength and width.
`
`The thickness may he constant ever the area at the surface: or may vary
`
`through a range of vaiues that are aii substantiaity srnaiier then the iength er
`
`width. decause the tiexihie membrane is iiexihie, it can assume a variety of
`
`15
`
`shapes, such as a sinner shape and a reiied shape} and such as the various
`
`shapes formed by the various surfaces at a subject‘s body. This, the itexihie
`
`body is configured to ties such that the hodymsontaet surface eenterms tn the
`
`portion of the subject‘s body,
`
`it shouid he noted that the phrase “body-Contact
`
`surface” shouid not he understood to require direct eentaet with the subject’s
`
`ES
`
`body. For exempts, the invention envisions that a sanitary drape eouid be
`
`interposed between the stimuiator hody~contaot surface during use.
`
`{0629}
`
`Te accommodate hath the desired ievei oi tiexihiiity and a desire fer
`
`the device to he easiiy eieaned, the hexihie hedy oeuid he made from an
`
`appropriate materiai, such as siiieone runner. The tiexihie circuit iii may he
`
`25
`
`embedded within the iiexihie hedy, raises to and extending paraiiei with the
`
`hedy—eentaet surface.
`
`

`

`W0 Zettdz’itifitfifi
`
`FCTEU’USZOtih/iMZS32
`
`7
`
`{05330}
`
`in an atternative variaticn,
`
`the etimutater hcdywccntact surface,
`
`withect euhetentiai determa‘dena may he designed tc ccnferm tc the certicn at
`
`the subject’s hcdy tc he eimetated. The ctimntater may then be configured
`
`either as rigid, or as cartiaiiy ctiahteg that
`
`is, ciiahie eniy te the extent
`
`necessary to acccmmcdate ehace changes that may cccdr as the certicn at
`
`the eubject'e hcdy mevee.
`
`{3931] With reference te FiG. 4, the device may further inciude ene or mere
`
`connecters 131 centigcred te hcid the flexihie hcdy tdt with respect to the
`
`echject‘e hedy each that the tiexihie ceit ie ccntcrmingiy received adjacent a
`
`1t}
`
`surface 133 ct the reievant perticn cf the enhject‘e hedy. The cennectcre
`
`ccutd he in the term of an adhesive? an adjcetahte Strap, an eieetic strap, a
`
`bandage, ctcthing, er ether ecch devices fer ccnterming and connecting the
`
`tiexihie memhrene tc e hedy. The driver may he carried by hand, er can be
`
`attached tc and wcrn eieewhere en the subject‘s hcdy.
`
`15
`
`{9632] With reference te HQ. 5,
`
`in cne variaticn at this emccdimeht the
`
`ttexihie bcdy "Em and the driver ”i055 (and therefore the rechargeahie pewer
`
`scarce and eignei generater) are etrccturaity interconnected.
`
`in the ccntext at
`
`this
`
`epciicaticn,
`
`it
`
`ehccid he understand that
`
`the
`
`term etructeratiy
`
`interconnected {with respect te two items) is defined he mean etrecteraiiy heid
`
`2G
`
`in cne ceciticn reietive tc cne encther, and capahie ct etrncturatty screeching
`
`cne another.
`
`{@333} Under cne exameie at this variatien,
`
`the tiexihie hedy may be
`
`strapped tc a subject’s hcdy certien {at}, an arm, a hand er the ecte of a
`
`fact), with the driver rigidty attached te a ccnnecting pcrticn ‘iéi‘t at the hexihie
`
`25
`
`body. The attachment may he detachahieg each as by a ctic that reedity ctics
`
`cntc a mating receptacie.
`
`

`

`Vii/'0 26081199058
`
`PCT/USZOGS/002832
`
`8
`
`{0034} Under ancther examcte at this variaticn,
`
`the attachment may he
`
`integrai. The eignai generater, rechargeahie battery and fiexitiie printed circuit
`
`ccii may he iaminated within the fiexihie hcdy, which can then he worn on the
`
`subject’s hcdy partied. As with the pricr examcie,
`
`this integrated certabie
`
`magnetic etimuiatcr can he ciaced an the hcdy, fer exampie en the head, and
`
`attached tiy meane at an adiuetahie strap, bandage, ciething, er the iike. An
`
`advantage at hath examniee at this variaticn ie that they can he made without
`
`a cahie, thereby eimciifying the magnetic etimniatcr fer a user,
`
`{6035]
`
`in the context at this ecciicatien,
`
`it shenid he understood that the
`
`10
`
`term integrai imciiee a cennectien that either cannot be detached, at can be
`
`detached cniy by a dieaeeemciy crcceee that wenid net frequentiy he
`
`attempted by a eubiect using the device” it ehcuid aiae he underetccd that the
`
`term detachahie attachment imciiee a cennecticn that is net integrai.
`
`@936} With reference to i463. 2 and 6, each tiexihie ccii “its is a fiat
`
`”i5
`
`magnetic ccii en a tiexihie printed circuit ‘itt containing cne er more epirai fiat
`
`ccii ccnductiye iayere. The tiexihie ccii defines; a generaiiy epitai cendcctcr
`
`path euhetantiaiiy paraiiei to the hedywcentact surface cf the tiexihie body. An
`
`advantage at ceing a fiexihie printed circuit fiat ccii is eaee cf manufacture and
`
`iew ceet ccmhined with duraciiity and fiexihiiity cf the ceii when worn in a
`
`20
`
`atrcctcraiiy chaiienging envirenrnent, euch as a ehee.
`
`{@337}
`
`he an examciey each tiexihie circuit 111 might be constructed with a
`
`1 ca, cancer thickneeeg and term twc epitai
`
`fiat cciie that are each
`
`accrcximateiy 1.5 in x 2.5 in, in area. Each at these ectrai cciie may have “fit
`
`turns with a 6 rnii trace width and a 4 mii space between traces ’iS’i. An inside
`
`25
`
`end at each ccii cennecte via a thrcugh hate 153 ta an cppceite surface at the
`
`fiexihie circuit, en which that end can extend hack tc eiectricaiiy ccnnect ta the
`
`eignai generater. The individuai ectrai cciie are eiectricaiiy ieeiated trcrn each
`
`

`

`‘WO 2038/109958
`
`E’CTIUSZGGBI’MZSLEZ
`
`9
`
`other and have separate teads 155 fer canneetion to the atgnai generator.
`
`The eteetrieat resistance at each individnai eeii is apprexirnateiy 3t) ehrne.
`
`{0038}
`
`A magnetic wave with apestrai frequency range ieee than 20 iii-i2
`
`might be generated using the signai generator 123 te drive the tiexihie oeiie at
`
`ieee than 10 Genes RMS (average) newer at magnetic that over the area to he
`
`stimuiated. The magnetic: wave may he hieeiar (atternating between positive
`
`and negative flux) er nniaeiar (eiternating between t) and either a positive or
`
`negative vaiue).
`
`[0039} Additionei
`
`fiat magnetic: stimniater eoiis may he inotdded en the
`
`if}
`
`tiexihie printed eirenit. The additienai etimutater edits are aieo driven by the
`
`signai generator using power
`
`from the power source.
`
`The additienei
`
`stirntiiater eoiia may at ieaet eartiaiiy ovarian the tiret endler aeeend stimuiater
`
`edits to provide for inereased teeai magnetic tieid strength end/er a more even
`
`distribution of magnetic fietd strength. Gntionaity, anon attrnuiator eeiie may be
`
`‘35
`
`made eonoentrie te increase teeai magnetic tieid strength.
`
`{0040}
`
`in a variatien of the embodiment, the tiexihie oeii may he a tinety
`
`wound wire eeii having widinge that extend around and aieng an axis running
`
`anhetantiaiiv nermai to the hedynoentaot surface.
`
`tvinitipie tineiy weand wire
`
`oeite oeaid he dietrihdted across the hodymeontaet surface area, and he
`
`20
`
`eenneeted in series or naraiiei as required to match eiectrieaiiy to the signai
`
`generater. Other eeii eent‘igurationa are aiso oeneidered within the scene at
`
`the invention.
`
`{GMT}
`
`The signat generator drivee time—varying current
`
`threagh the
`
`etimniater eeiia ta deiiver timenvarying magnetic tieide to the pertien at the
`
`25
`
`subject’s body. The Signet generater they ineiade a timer circuit that switches
`
`the battery current on and aft through a Bartingten pair arrangement of
`
`

`

`‘WO 2338/109058
`
`PCT/USZGUSIOQZEBZ
`
`‘i 0
`
`treneistere tn the printed circuit eeii at varying ieveie. The deiivery at e wide
`
`variety of timewarying magnetic wevee is within the scene at the inventien.
`
`{3042]
`
`Fer exempie, ene bessibiiity under the present invention is the use et
`
`at enibeier magnetic wave with treeueney et 506 Hz is need and a peek
`
`()1
`
`instantaneeue tiex density at between {3.5 and 8 Gauss (ii to beak) and a DC
`
`tiux Eeyet et between 1 end 5 genes. Aiternetiveiy the eriving weyeterm maybe
`
`AC with a peak inetanteneeiie tiux density at between t entt ’ib Genes (peak
`
`to beak) and e DC iinx ievei et approximateiy t). The driving signei (entbut bi
`the eignai generater) mey subetentieiiy be e square wave at 500 Hz. The size
`
`it)
`
`(eree) et the anti may be ebpreximeteiy “7.5 mi and the stimuiatien time might
`
`be between 30 minutes and 3 hours.
`
`{0043}
`
`in anether beesibiiity,
`
`the magnetic stimuietien may be emitted.
`
`Pniees may be deiivered by a teneuburet in which e fixed number et’ eycies bi
`
`e sinueeidei, equere, er trienguiar wave are transmitted, teiiewett by e period
`
`‘25
`
`et' ne trensmieeien, end then repeated. The tone beret frequency might vary
`
`between 6 end 22 Hz end the number of eyeiee between 2 end 8.
`
`Fer
`
`exempie e singie pnise, er tenenburst, can be matte by transmitting 4 eyeiee et
`
`a 14» Hz sine wave. The beriett er? the tene—bnrst, er the time between buisee,
`
`is then varied for exembie between 0.6 seeeniie and 2 secende. By varying
`
`2E)
`
`the tene burst frequency, the number bi eyeiee transmitted, and the peried
`
`(time between berets) during the ebbiieatien the magnetic etimiiietien might be
`
`made tn be more eernpetibie with the bedy, es ebpesed te using a fixed
`
`frequency and fixed peried et stimuietien. The etirniiiue can be made tn
`
`abbreximate e Peieeen dietributien,
`
`e @eueeian distribution, er other
`
`25
`
`centinuens distributien tenetien,
`
`{00443 With reference te FEES. 3.
`
`in yet enether beseibiiity.
`
`the Signet
`
`generater may ineiutie a eentreiier tat bentigurett
`
`tn access e rewritabie
`
`memery 153. The memery eteres wayeterm intermatien. and the Signet
`
`

`

`‘W0 26(38/109058
`
`PCT/U SZiititi/titiZSESZ
`
`’i 1
`
`generator is configured to controi
`
`the time—varying current based on the
`
`waveform information stored in the memory. As a resuits the signai generator
`
`may be configured to provide a variety of different
`
`types of magnetic
`
`stimuiaiion, and it might further be configured to have the types of magnetic
`
`stimuiation changed or upgraded using an externai communication port"
`
`{0045}
`
`thionaiiy.
`
`the waveform information may he mathematicai
`
`information from which a waveform can be caicuiatedt The eignai generator
`
`wouid he contigured to controi the timewvarying current based on caicuiatione
`
`using the waveform information stored in the memory” As a resuit,
`
`the
`
`it)
`
`quantity of waveform information needing to be stored, read andlor input might
`
`be significantiy reduced.
`
`‘
`
`{(23946} With reference to FiG. 4, the device can further inciude asensor
`
`configured to sense a response to the time~varying magnetic fieide by the
`
`subjeete body. The signai generator may then be configured to contrci the
`
`15
`
`tinrewvarying current based on sensed response, such as with a feedback
`
`circuit configured to guide the body‘s response to a desired responee ievei.
`
`Furthermore? in the case where muitipie coiis are used, one or more sensors
`
`can he used to taiior siimuiation ieveis over a given area to better achieve a
`
`deeired resuit.
`
`2G
`
`{0047’} Depending on which part of the suhieot body is to be stimuiated,
`
`various types of seneore might be used. For exampiea if the eoui of the
`
`subject‘s foot in to he stimuiated, the eeneor might be puiee oximeter, which
`
`wouid he usefui for sensing hiood oxygen ieveis. Likewise: it a euhiect head is
`
`to he stimuiated,
`
`the sensor might be en eiectroencephaiograph eieotrode,
`
`25
`
`which wouid be appropriate for sensing brain wave activity.
`
`{c048}
`
`thionaiiy, an MP3 portahie audio piayer such as iPod Shuffle
`
`{or
`
`other such portahie audio piayer) may he used as the driver. Under this
`
`

`

`‘WO 2338/109058
`
`PCT/'USZGUS/OQZEBZ
`
`’i 2
`
`veriaticng an audit) arnpiitier serves as the signai generater, and is integrated
`
`with a rechergeebie battery, a rnemcry,‘ and a centreiier centigured te
`
`seiectiveiy use waveicrrn interrnatien read trarn the rnernery in drive a time“
`
`varying current tcr use by the stimuiater.
`
`{0049] Advantagecusiy, the use at such devices weuid provide a tarniiiar,
`
`user—identity interface for a subject, whc rnay aiready have carnpatibie battery
`
`chargers and ether accesseriesu Additionaiiy, the infrastructure fer previding
`
`subjects with updated waveterrn intermaticn (such as ever the internet) is wait
`
`deveiaped and cernmerciaiiy avaiiabieu Aisc, such devices are designed fer
`
`it}
`
`unitcrrn eutput pewer ever the tits at the battery, white being at iew cast and
`
`srnaii size.
`
`EGGSQi
`
`in use, it is anticipated that the a it} minute steree M93 tiie weuid be
`
`generated for a sine wave at Edi) its (an each channei). The MP3 tiie weuid
`
`be dewnieaded to the MP3 piayer using existing resources such as the Appie
`
`'15
`
`iTunes ® setheare. The MP3 piayer weuid be turned an and the veiurne
`
`settings set to maximum. Such settings sheuid previde consistent ieveis at
`
`stimuiatien trern ene use in the next. The battery iite at the MP3 piayer is
`
`anticipated in be appreximateiy ieur ta five hours in the abeve described
`
`cantiguratien based an existing MP3 piayers, and wcuid have changeabie /
`upgradabie stirnuiatien prcgremrning.
`
`2G
`
`{Outfit} Aiternativeiy, ether audie range signai generaters are within the
`
`scape at the inventien.
`
`it shcuid be neted that the use at a partabie audie
`
`piayer to drive two separate caiis, each ceii being driven by a separate
`
`channei at the audic piayer, provides far more efficient use at the iin’rited
`
`25
`
`newer avaiiabie on each channei at a given partabie audie piayer. Thus, by
`
`using both channeis en maximum pcwer, censentricaiiy pieced ceiis can
`
`achieve higher ieveis ct stimuiatien than might cthenivise be achieved using
`
`the pertabie audic piayer. Likewise, by using hath channeis an rnaxirnurn
`
`

`

`‘WO 2338/109058
`
`PCT/'USZGUS/OQZEBZ
`
`”i 3
`
`power, everiaeping but not eenoentrieaiiy pieced ceiis can achieve a wider
`
`area e‘i etimniatien than might etherwiee he achieved using the portahie audie
`
`eiayeru Moreever, the eertabie audie eiayer may contrei the separate oharmei
`
`signaie to taiier the ieveis of etimuiatien given te separate {theugh tyeioaiiy
`
`eioee) eertiens of the hedy.
`
`[0052} With reference te Fig. 3’, another embodiment et a eertahie device
`
`ter the deiivery of desired time~varying magnetic tieids may he seeeitieaiiy
`
`eentigured for use with a subject's feet (and eartieuiariy the eeie ef the feet)
`
`white the eersen is mehiie.
`
`in this case the operating envirenment is very
`
`it)
`
`ehaiienging, as the eeie of a tent carries the entire hedy weight, and must flex
`
`white waiiting.
`
`in this aeeiicetion, a pereen is undereteed in he rnehiie it they
`
`are tree et any tether, such as a power cent, and it they are net encumbered
`
`by any devices that weuid significantiy iirnit their ahiiity te traneeert themseivee
`
`by their conventionai means (ed, by waking)"
`
`15
`
`[0053}
`
`This embediment ineiudes a etimuiator in the term et a tiexieie body
`
`261. The tiexieie hedy is attached by a oahie 203 to a driver 205. As hetere,
`
`the tiexihte hedy ineereeratee a tiexihie circuit Zii that inciudee twe stimuiater
`
`coiie in the term of tiexihie ceiie that de net everiap. Simiiariy this driver aieo
`
`ineiudee a reohargeahie newer seeree such as a battery, and a signai
`
`20
`
`generater that are etrneturaiiy interconnected by a driver hedy. The signai
`
`generater is oentigured te tree power from the newer source te drive a time“
`
`varying current threugh the twe iiexihie eeiie via the cahie, which eiectricaiiy
`
`intereonneete the tiexihie eeiie and the signai generater.
`
`{(3054}
`
`This embodiment provides an item at footwear that ineereeretes the
`
`25
`
`stimuiater.
`
`tviere partieuieriy,
`
`the item at teetwear ineiudee a euhetantiaiiy
`
`typicai ehee upper 2771 and a typicai ehee eeteeie 273. The integrated ueeer
`
`and outsoie term a etrueturai eiement eentigured te receive the subject's feet.
`
`

`

`‘W0 HMS/109058
`
`PCT/U SEtitMfi/GGZSSZ’;
`
`14
`
`in this case, the etirnuiator is an integrai insoie that incorporates the tiexihie
`
`circuit and is structuraiiy interconnected to the structurai eiement.
`
`{case}
`
`it
`
`is noteworthy that the footwear is not simpiy a iimited orthotic
`
`device. The ootsoie extends across the entire bottom of the foot, providing
`
`protection from the ground in the form of a portahie surface to waik upon.
`
`Moreover, the outsoie is tiexioie enough to aiiow for the flexing of a foot white
`
`waiking.
`
`{0058}
`
`,As before, the stimuiator has a oody~contact surface configured to
`
`conform to the portion of the foot to he stimuiated. The structurai eternent is
`
`10
`
`configured to contormingiy hotci the stimuiator with respect to the subject’s toot
`
`such that the stimuiatoi‘ coii is contormingiy received adjacent the portion of
`
`the suhiect's foot to he stimuieted.
`
`it is further configured to maintain the
`
`stimoiator in this position white the subject is waihings despite the changing
`
`shape of the subject’s foot that occurs.
`
`15
`
`{395?}
`
`thionaiiy, the etimuiator may he a tiexibie oody configured to tiex
`
`such that the oodyucontact surface conforms to the portion of the sooiect
`
`body. Aiternativeiy, the hodymcontect surface, without suhstantiai deformation,
`
`may he designed to conform to the toot. The stimuiator may then be
`configured either as rigid, or as pertiaiiy piiahie, that is, piiahie oniy to the
`
`26
`
`extent necessary to accommodate shape changes that may occur as the
`portion of the subject's hody moves. The rigid and partiatiy piiahie options
`
`may he particuiariy usefui when the stiinuietor is used on body portions that
`
`may require support (eg, when the stirnoiator is incorporated into an insoie).
`
`{0058}
`
`The structurai eiement upper typicaiiy wiii be in the term of a shoe
`
`upper, protecting and covering most or aii of the foot.
`
`To conceai
`
`the
`
`presence oi the device! the structurai eiement may appear as e typicat shoe,
`
`

`

`we wee/times
`
`FCTi‘lUSZiNiti/iidlfiz
`
`’i 5
`
`{0059}
`
`The item at feetvvear mayi he a cemeieteiv custom—designed item, or
`
`it may,i he a cemmemiaiiy avaiiahie item which has had its inseie remeved and
`
`repiaced with an inseie having a stimeiater ceii.
`
`[09in As depicted in FiG.
`
`"i",
`
`in this emhediment the integrated driver,
`
`incieding the signai generater and the rechargeehie sewer seams, are
`
`structuraiiy intercennected te the structurai eiement (e.g., en the Lieder), The
`
`cennectien may he detachahie hem the structurei eiement, such as using a
`
`ciie that readiiy cites ehte a mating reeeptaeie, er the cenneetien may be
`
`integrai.
`
`it)
`
`{096% The streetsrai eiement may form a heei. As depicted in FiG. d,
`
`in a
`
`variatien of
`
`this embodiment,
`
`the integrated driver,
`
`incieding the signai
`
`generater and the rechergeehie sewer seams, are ineereerated inte the heeia
`
`and are thus integrai with the item at ieetweer.
`
`{0962} White it is aeeerent trem the figures that the item at teetwear can he
`a shoe, a siieeer, a beet er the iiite,
`it sheeid he hated that numerous other
`
`15
`
`variatiens exist.
`
`in e distentiy reiated embediment, the structurai eiement
`
`ceuid aise he a sack en which a stimeiater is meented (as depicted in Fit}. 9).
`
`{0063} Whiie the eheve described items at teetwear are cestem items, sash
`as a shoe having its integrai inseie remeved and a stimeiater inseie integraiiy
`
`2Q
`
`attached, ether embediments may he designed as inserts is he pieced within
`
`standard teetwear.
`
`Fer examnie!
`
`the streeterai eiement may censist
`
`essentiaiiy at an inseie that incereerates a reehargeahie sewer seerce, a
`
`signai generator, a cahie and a iiexihie circuit with its stimeiater eeii, as
`
`depicted in FBGS.
`
`tilt and “it.
`
`in these figures, it can be seen that the inseie
`
`25
`
`inciedes a iiexibie circuit Silt, a structurai eiement 3033 a battery 305, a signai
`
`generater 307, and e cennecter 399 threugh which the device may be
`
`eennected to a sewer sedrce andier a data seurce.
`
`

`

`WO 2338/109958
`
`PCT/USEfltiti/OTEZSLSZ
`
`i 6
`
`[0964} As in the previeus embodiments, the driver seuit‘i he an audie signai
`
`generater such as an M93 audie piayer, but it sheuit‘i he reeegnizett that
`
`significant size iimitetiens exist fer the driver in this emhettirnent,
`
`{0055]
`
`The inventien further inciuees a methee tar deiivering tirneuverying
`
`magnetic tieids is a portion at a subject‘s body using varieus emheeiments at
`
`the pertahte device, as described eheve. The methed inciudes the step at
`
`meenting the stimuieter en the pcrtipn of the subject's heey such that it can be
`
`carried en the subjects hedyu Fer embedirnents that are wearahie artistes”
`
`such as a shee, a hat, a scarf, at other garment incerperating a stirnuiatara this
`
`10
`
`step inveives denning the artiste. Fer emhediments that must he separateiy
`
`attached the step invetves piecing the stimuietcr against the pertien at the
`
`subject’s batty, and attaching it t