(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2015/0165226A1
`(43) Pub. Date:
`Jun. 18, 2015
`Simon et al.
`
`US 2015O165226A1
`
`(54)
`
`(71)
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`(72)
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`(21)
`(22)
`
`(60)
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`(60)
`
`MAGNETIC STIMULATION DEVICES AND
`METHODS OF THERAPY
`
`Applicant: Electrocore, LLC, Basking Ridge, NJ
`(US)
`Inventors: Bruce J. Simon, Mountain Lakes, NJ
`(US); Joseph P. Errico, Warren, NJ
`(US); Jonn T. Raffle, Austin, TX (US)
`Appl. No.: 14/636,498
`
`Filed:
`
`Mar. 3, 2015
`
`Related U.S. Application Data
`Division of application No. 13/938,931, filed on Jul.
`10, 2013, now Pat. No. 8,972,004, which is a division
`of application No. 12/964,050, filed on Dec. 9, 2010,
`said application No. 13/938.931 is a continuation-in
`part of application No. 12/859.568, filed on Aug. 19.
`2010, which is a continuation-in-part of application
`No. 12/408, 131, filed on Mar. 20, 2009, now Pat. No.
`8,812,112, which is a continuation-in-part of applica
`tion No. 1 1/591,340, filed on Nov. 1, 2006, now Pat.
`No. 7,747,324.
`Provisional application No. 61/415,469, filed on Nov.
`19, 2010, provisional application No. 60/814.313,
`filed on Jun. 16, 2006, provisional application No.
`60/786,564, filed on Mar. 28, 2006, provisional appli
`cation No. 60/772,361, filed on Feb. 10, 2006, provi
`
`sional application No. 60/736,002, filed on Nov. 10,
`2005, provisional application No. 60/736,001, filed on
`Nov. 10, 2005.
`
`Publication Classification
`
`(2006.01)
`(2006.01)
`
`(51) Int. Cl.
`A6N2/02
`A6N2/00
`(52) U.S. Cl.
`CPC. A61N 2/02 (2013.01); A61N 2/006 (2013.01)
`ABSTRACT
`(57)
`Devices and systems are disclosed for the non-invasive treat
`ment of medical conditions through delivery of energy to
`target tissue, comprising a source of electrical power, a mag
`netically permeable toroidal core, and a coil that is wound
`around the core. The coil and core are embedded in a con
`tinuous electrically conducting medium, which is adapted to
`have a shape that conforms to the contour of an arbitrarily
`oriented target body Surface of a patient. The conducting
`medium is applied to that Surface by any of several disclosed
`methods, and the source of power Supplies a pulse of electric
`charge to the coil. Such that the coil induces an electric current
`and/or an electric field within the patient, thereby stimulating
`tissue and/or one or more nerve fibers within the patient. The
`invention shapes an elongated electric field of effect that can
`be oriented parallel to a long nerve. In one embodiment, the
`device comprises two toroidal cores that lie adjacent to one
`another.
`
`Sewice 3
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`MAGNETIC STIMULATION DEVICES AND
`METHODS OF THERAPY
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`
`0001. The present application is a Divisional of U.S.
`patent application Ser. No. 13/938.931 filed 10 Jul. 2013,
`which is a Divisional of U.S. patent application Ser. No.
`12/964,050 filed 9 Dec. 2010, which claims the benefit of
`U.S. Provisional Application Ser. No. 61/415,469 filed 19
`Nov. 2010; and is a Continuation in Part of U.S. patent appli
`cation Ser. No. 12/859,568 filed 19 Aug. 2010, which is a
`Continuation in Part of U.S. patent application Ser. No.
`12/408,131 filed 20 Mar. 2009, now U.S. Pat. No. 8,812,112
`issued 19 Aug. 2014, which is a Continuation in Part of U.S.
`patent application Ser. No. 1 1/591.340, filed 1 Nov. 2006,
`now U.S. Pat. No 7,747,324 issued 29 Jun. 2010, which
`claims the benefit of U.S. Provisional Application Ser. Nos.
`60/814,313 filed 16 Jun. 2006, 60/786,564 filed 28 Mar. 2006,
`60/772,361 filed 10 Feb. 2006, 60/736,002 filed 10 Nov.
`2005, and 60/736,001 filed 10 Nov. 2005; each of which is
`incorporated herein by reference in its entirety.
`
`BACKGROUND OF THE INVENTION
`
`0002 The field of the present invention relates to the deliv
`ery of energy impulses (and/or fields) to bodily tissues for
`therapeutic purposes. It relates more specifically to toroidal
`magnetic stimulation devices, as well as to non-invasive
`methods for treating medical conditions using energy that is
`delivered by such devices. The medical conditions include,
`but are not limited to, post-operative ileus, neurodegenerative
`disorders (such as Alzheimer's disease), post-operative cog
`nitive dysfunction (POCD), post-operative delirium (POD),
`dementia, rheumatoid arthritis, acute and chronic depression,
`epilepsy, Parkinson's disease, multiple sclerosis (MS), bron
`choconstriction associated with asthma, anaphylaxis or
`COPD, sepsis or septic shock, hypovolemia or hypovolemic
`shock, orthostatic hypotension, hypertension, urinary incon
`tinence and/or overactive bladder, and sphincter of Oddi dys
`function.
`0003 Treatments for various infirmities sometime require
`the destruction of otherwise healthy tissue in order to produce
`a beneficial effect. Malfunctioning tissue is identified and
`then lesioned or otherwise compromised in order to produce
`a beneficial outcome, rather than attempting to repair the
`tissue to its normal functionality. A variety of techniques and
`mechanisms have been designed to produce focused lesions
`directly in target nerve tissue, but collateral damage is inevi
`table.
`0004. Other treatments for malfunctioning tissue can be
`medicinal in nature, but in many cases the patients become
`dependent upon artificially synthesized chemicals. Examples
`of this are anti-asthma drugs such as albuterol, proton pump
`inhibitors such as omeprazole (PRILOSECR), spastic blad
`der relievers such as DITROPANR), and cholesterol reducing
`drugs such as LIPITOR(R) and ZOCORR). In many cases,
`these medicinal approaches have side effects that are either
`unknown or quite significant. For example, at least one popu
`lar diet pill of the late 1990s was subsequently found to cause
`heart attacks and strokes. Unfortunately, the beneficial out
`comes of Surgery and medicines are often realized at the cost
`of function of other tissues, or risks of side effects.
`
`0005. The use of electrical stimulation for treatment of
`medical conditions has been well known in the art for nearly
`two thousand years. It has been recognized that electrical
`stimulation of the brain and/or the peripheral nervous system
`and/or direct stimulation of the malfunctioning tissue holds
`significant promise for the treatment of many ailments,
`because Such stimulation is generally a wholly reversible and
`non-destructive treatment.
`0006 Nerve stimulation is thought to be accomplished
`directly or indirectly by depolarizing a nerve membrane,
`causing the discharge of an action potential; or by hyperpo
`larization of a nerve membrane, preventing the discharge of
`an action potential. Such stimulation may occur after electri
`cal energy, or also otherforms of energy, are transmitted to the
`vicinity of a nerve F. RATTAY. The basic mechanism for the
`electrical stimulation of the nervous system. Neuroscience
`Vol. 89, No. 2, pp. 335-346, 1999; Thomas HEIMBURG and
`Andrew D. Jackson. On soliton propagation in biomem
`branes and nerves. PNAS vol. 102 (no. 28, Jul. 12, 2005):
`9790-9795. Nerve stimulation may be measured directly as
`an increase, decrease, or modulation of the activity of nerve
`fibers, or it may be inferred from the physiological effects that
`follow the transmission of energy to the nerve fibers.
`0007 Electrical stimulation of the brain with implanted
`electrodes has been approved for use in the treatment of
`various conditions, including pain and movement disorders
`Such as essential tremor and Parkinson's disease. The prin
`ciple underlying these approaches involves disruption and
`modulation of hyperactive neuronal circuit transmission at
`specific sites in the brain. Unlike potentially dangerous
`lesioning procedures in which aberrant portions of the brain
`are physically destroyed, electrical stimulation is achieved by
`implanting electrodes at these sites. The electrodes are used
`first to sense aberrant electrical signals and then to send
`electrical pulses to locally disrupt pathological neuronal
`transmission, driving it back into the normal range of activity.
`These electrical stimulation procedures, while invasive, are
`generally conducted with the patient conscious and a partici
`pant in the Surgery.
`0008 Brain stimulation, and deep brain stimulation in par
`ticular, is not without some drawbacks. The procedure
`requires penetrating the skull, and inserting an electrode into
`brain matter using a catheter-shaped lead, or the like. While
`monitoring the patient's condition (Such as tremor activity,
`etc.), the position of the electrode is adjusted to achieve sig
`nificant therapeutic potential. Next, adjustments are made to
`the electrical stimulus signals. Such as frequency, periodicity,
`Voltage, current, etc., again to achieve therapeutic results. The
`electrode is then permanently implanted, and wires are
`directed from the electrode to the site of a surgically
`implanted pacemaker. The pacemaker provides the electrical
`stimulus signals to the electrode to maintain the therapeutic
`effect. While the therapeutic results of deep brain stimulation
`are promising, there are significant complications that arise
`from the implantation procedure, including stroke induced by
`damage to Surrounding tissues and the neuro-vasculature.
`0009. One of the most successful applications of modern
`understanding of the electrophysiological relationship
`between muscle and nerves is the cardiac pacemaker.
`Although origins of the cardiac pacemaker extend back into
`the 1800s, it was not until 1950 that the first practical, albeit
`external and bulky, pacemaker was developed. The first truly
`functional, wearable pacemaker appeared in 1957, and in
`1960, the first fully implantable pacemaker was developed.
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`0010 Around this time, it was also found that electrical
`leads could be connected to the heart through veins, which
`eliminated the need to open the chest cavity and attach the
`lead to the heart wall. In 1975 the introduction of the lithium
`iodide battery prolonged the battery life of a pacemaker from
`a few months to more than a decade. The modern pacemaker
`can treat a variety of different signaling pathologies in the
`cardiac muscle, and can serve as a defibrillator as well (see
`U.S. Pat. No. 6,738,667 to DENO, et al., the disclosure of
`which is incorporated herein by reference).
`0011. Another application of electrical stimulation of
`nerves has been the treatment of radiating pain in the lower
`extremities by stimulating the sacral nerve roots at the bottom
`of the spinal cord (see U.S. Pat. No. 6,871,099 to WHITE
`HURST, et al., the disclosure of which is incorporated herein
`by reference).
`0012. The present disclosure involves devices and medical
`procedures that stimulate nerves by transmitting energy to
`nerves and tissue non-invasively. A medical procedure is
`defined as being non-invasive when no break in the skin (or
`other surface of the body, such as a wound bed) is created
`through use of the method, and when there is no contact with
`an internal body cavity beyond a body orifice (e.g., beyond
`the mouth or beyond the external auditory meatus of the ear).
`Such non-invasive procedures are distinguished from inva
`sive procedures (including minimally invasive procedures) in
`that invasive procedures do involve inserting a Substance or
`device into or through the skin or into an internal body cavity
`beyond a body orifice.
`0013 Potential advantages of such non-invasive medical
`methods and devices relative to comparable invasive proce
`dures are as follows. The patient may be more psychologi
`cally prepared to experience a procedure that is non-invasive
`and may therefore be more cooperative, resulting in a better
`outcome. Non-invasive procedures may avoid damage of bio
`logical tissues, such as that due to bleeding, infection, skin or
`internal organ injury, blood vessel injury, and vein or lung
`blood clotting. Non-invasive procedures are sometimes pain
`less or only minimally painful and may be performed without
`the need for even local anesthesia. Less training may be
`required for use of non-invasive procedures by medical pro
`fessionals. In view of the reduced risk ordinarily associated
`with non-invasive procedures, some such procedures may be
`suitable for use by the patient or family members at home or
`by first-responders at home or at a workplace, and the cost of
`non-invasive procedures may be reduced relative to compa
`rable invasive procedures.
`0014 For example, transcutaneous electrical nervestimu
`lation (TENS) is non-invasive because it involves attaching
`electrodes to the Surface of the skin (or using a form-fitting
`conductive garment) without breaking the skin. In contrast,
`percutaneous electrical stimulation of a nerve is minimally
`invasive because it involves the introduction of an electrode
`under the skin, via needle-puncture of the skin. Both TENS
`and percutaneous electrical stimulation can be to Some extent
`unpleasant or painful, in the experience of patients that
`undergo such procedures. In the case of TENS, as the depth of
`penetration of the stimulus under the skin is increased, any
`pain will generally begin or increase.
`0.015 The form of non-invasive electrical stimulation with
`which the present application is primarily concerned is mag
`netic stimulation. It involves the induction, by a time-varying
`magnetic field, of electrical fields and current within tissue, in
`accordance with Faraday's law of induction. Magnetic stimu
`
`lation is non-invasive because the magnetic field is produced
`by passing a time-varying current through a coil positioned
`outside the body, inducing at a distance an electric field and
`electric current within electrically-conducting bodily tissue.
`Because the induced electric field and induced current depend
`not only upon current being passed through wire of the coil,
`but also upon the permeability of core material around which
`the coil may be wound, the term coil as used herein refers not
`only to the current-carrying wire, but also to the core material,
`unless otherwise indicated.
`0016 Large, pulsed magnetic fields (PMF) can induce
`significant electric fields in conducting media, including
`human tissue. Particular waveforms and amplitudes can
`stimulate action potentials in nerves, both in vitro and in vivo.
`Due to the noninvasive nature of the stimulation, PMF
`devices have found utility in several clinical applications,
`both therapeutically, e.g., for treating depression via transc
`ranial magnetic stimulation (TMS), and diagnostically, for
`peripheral nerve stimulation. It is an objective of the present
`invention to use magnetic stimulation to produce significantly
`less pain or discomfort, as compared with that experienced by
`the patient undergoing a treatment with TENS, for a given
`depth of stimulus penetration. Or conversely, for a given
`amount of pain or discomfort on the part of the patient (e.g.,
`the threshold at which Such discomfort or pain begins), an
`objective of the present invention is to achieve a greater depth
`of penetration of the stimulus under the skin.
`0017. The principle of operation of magnetic stimulation,
`along with a description of commercially available equip
`ment and a list of medical applications of magnetic stimula
`tion, is reviewed in: Chris HOVEY and Reza Jalinous, The
`Guide to Magnetic Stimulation, The Magstim Company Ltd,
`Spring Gardens, Whitland, Carmarthenshire, SA34 OHR,
`United Kingdom, 2006. The types of the magnetic stimulator
`coils that are described there include circular, parabolic, fig
`ure-of-eight (butterfly), and custom designs. Additional types
`of the magnetic stimulator coils are described in patent U.S.
`Pat. No. 6,179,770, entitled Coil assemblies for magnetic
`stimulators, to MOULD; as well as in Kent DAVEY. Mag
`netic Stimulation Coil and Circuit Design. IEEE Transactions
`on Biomedical Engineering, Vol. 47 (No. 11, November
`2000): 1493-1499 and in HSU KH, Nagarajan SS, Durand D
`M. Analysis of efficiency of magnetic stimulation. IEEE
`Trans Biomed Eng. 2003 November; 50 (11):1276-85.
`0018. The circuits that are used to send pulses or other
`waveforms through magnetic stimulator coils are also
`described by HOVEY and Jalinous in The Guide to Magnetic
`Stimulation that was cited above. Custom magnetic stimula
`tor circuits for control, impulse generator and power Supply
`have also been described Eric BASHAM, ZhiYang, Natalia
`Tchemodanov, and Wentai Liu. Magnetic Stimulation of
`Neural Tissue: Techniques and System Design. pp. 293-352,
`In: Implantable Neural Prostheses 1, Devices and Applica
`tions, D. Zhou and E. Greenbaum, eds., New York: Springer
`(2009): U.S. Pat. No. 7,744,523, entitled Drive circuit for
`magnetic stimulation, to EPSTEIN: U.S. Pat. No. 5,718,662,
`entitled Apparatus for the magnetic stimulation of cells or
`tissue, to JANILOUS; U.S. Pat. No. 5,766,124, entitled Mag
`netic stimulator for neuro-muscular tissue, to POLSON.
`0019. As described in the above-cited publications, the
`circuits for magnetic stimulators are generally complex and
`expensive. They use a high current impulse generator that
`may produce discharge currents of 5,000 amps or more,
`which is passed through the stimulator coil, and which
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`thereby produces a magnetic pulse. Typically, a transformer
`charges a capacitor in the impulse generator, which also con
`tains circuit elements that limit the effect of undesirable elec
`trical transients. Charging of the capacitoris under the control
`of a control unit, which accepts information Such as the
`capacitor Voltage, power and other parameters set by the user,
`as well as from various safety interlocks within the equipment
`that ensure proper operation, and the capacitor is then dis
`charged through the coil via an electronic Switch (e.g., a
`controlled rectifier) when the user wishes to apply the stimu
`lus. Greater flexibility is obtained by adding to the impulse
`generator a bank of capacitors that can be discharged at dif
`ferent times. Thus, higher impulse rates may be achieved by
`discharging capacitors in the bank sequentially, such that
`recharging of capacitors is performed while other capacitors
`in the bank are being discharged. Furthermore, by discharg
`ing some capacitors while the discharge of other capacitors is
`in progress, by discharging the capacitors through resistors
`having variable resistance, and by controlling the polarity of
`the discharge, the control unit may synthesize pulse shapes
`that approximate an arbitrary function.
`0020. Another practical disadvantage of magnetic stimu
`lator coils is that they overheat when used over an extended
`period of time, because large coil currents are required to
`reach threshold electric fields in the stimulated tissue. At high
`repetition rates, currents can heat the coils to unacceptable
`levels in seconds to minutes, depending on the power levels
`and pulse durations and rates. Accordingly, coil-cooling
`equipment is used, which adds complexity to the magnetic
`stimulator coils. Two approaches to overcome heating are to
`cool the coils with flowing water or air or to increase the
`magnetic fields using ferrite cores (thus allowing Smaller
`currents). For some applications where relatively long treat
`ment times at high stimulation frequencies may be required,
`e.g. treating asthma by stimulating the vagus nerve, neither of
`these two approaches may be adequate. Water-cooled coils
`overheat in a few minutes. Ferrite core coils heat more slowly
`due to the lower currents and heat capacity of the ferrite core,
`but they also cool slowly and do not allow for water-cooling
`because the ferrite core occupies the volume where the cool
`ing water would flow. One solution to this problem is to use a
`core that contains ferrofluids U.S. Pat. No. 7,396,326 and
`published applications US20080114199, US20080177128,
`and US20080224808, all entitled Ferrofluid cooling and
`acoustical noise reduction in magnetic stimulators, respec
`tively to GHIRON et al., RIEHL et al., RIEHL et al. and
`GHIRON et al.). However, even the use of ferrofluids may be
`inadequate when long treatment times at high stimulation
`frequencies may be required.
`0021. Another problem that is sometimes encountered
`during magnetic stimulation is the unpleasantness or pain that
`is experienced by the patient in the vicinity of the stimulated
`tissue. Little is known about the mechanism that produces the
`pain, although it is generally recognized that magnetic stimu
`lation produces less pain than its electrode-based counterpart.
`Most investigations that address this question examine pain
`associated with transcranial stimulation.
`0022 ANDERSON etal found that when magnetic stimu
`lation is repeated over the course of multiple sessions, the
`patients adapt to the pain and exhibit progressively less dis
`comfort Berry S. ANDERSON, Katie Kavanagh, Jeffrey J.
`Borckardt, Ziad H. Nahas, Samet Kose, Sarah H. Lisanby,
`William M. McDonald, David Avery, Harold A. Sackeim, and
`Mark S. George. Decreasing Procedural Pain Over Time of
`
`Left Prefrontal rTMS forDepression: Initial Results from the
`Open-Label Phase of a Multisite Trial (OPTTMS). Brain
`Stimul. 2009 Apr. 1; 2(2): 88-92). Other than waiting for the
`patient to adapt, strategies to reduce the pain include: use of
`anesthetics placed on or injected into the skin near the stimu
`lation and placement of foam pads on the skin at the site of
`stimulation Jeffrey J. BORCKARDT, Arthur R. Smith,
`Kelby Hutcheson, Kevin Johnson, Ziad Nahas, Berry Ander
`son, M. Bret Schneider, Scott T. Reeves, and Mark S. George.
`Reducing Pain and Unpleasantness During Repetitive Tran
`scranial Magnetic Stimulation. Journal of ECT 2006: 22:259
`264, use of nerve blockades V. HAKKINEN, H. Eskola, A.
`Yli-Hankala, T. Nurmikko and S. Kolehmainen. Which struc
`tures are sensitive to painful transcranial stimulation? Elec
`tromyogr, clin. Neurophysiol. 1995, 35:377-383), the use of
`very short stimulation pulses IV. SUIHKO. Modelling the
`response of Scalp sensory receptors to transcranial electrical
`stimulation. Med. Biol. Eng. Comput., 2002, 40, 395-401.
`and providing patients with the amount of information that
`suits their personalities Anthony DELITTO, Michael J
`Strube, Arthur D Shulman, Scott D Minor. A Study of Dis
`comfort with Electrical Stimulation. Phys. Ther. 1992:
`72:410-424. U.S. Pat. No. 7,614,996, entitled Reducing dis
`comfort caused by electrical stimulation, to RIEHL discloses
`the application of a secondary stimulus to counteract what
`would otherwise be an uncomfortable primary stimulus.
`However, these methods of reducing pain or discomfort on
`the part of the stimulated patient are not always successful or
`practical.
`
`SUMMARY OF THE INVENTION
`0023 The present invention discloses devices and meth
`ods for the non-invasive treatment of medical conditions,
`utilizing an energy source that transmits energy non-inva
`sively to bodily tissue. In particular, the device can transmit
`energy to, or in close proximity to, one or more selected
`nerves to temporarily stimulate, block and/or modulate elec
`trophysiological signals in the selected nerves.
`0024. In one aspect of the invention, an apparatus for
`applying energy transcutaneously to a target region within a
`patient comprises a source of energy for generating a mag
`netic field that is located essentially entirely exterior to an
`outer skin Surface of the patient and a conduction medium
`through which an electrical current induced by the magnetic
`field penetrates the outer skin surface of the patient. The
`Source of energy and the conduction medium are configured
`to shape the electrical field that is induced by the magnetic
`field, such that energy from the induced electric field and/or
`induced current is sufficient to modulate a nerve at the target
`region. The Source of energy is preferably a source of elec
`trical energy coupled to a coil housed within an enclosure that
`is configured to contain the magnetic field therein.
`0025. In one embodiment, the source of energy comprises
`a source of electrical energy coupled to first and second coils
`configured to generate first and second time-varying mag
`netic fields; each coil being housed within an enclosure con
`figured to Substantially confine the magnetic field therein.
`The first and second coils are preferably toroidal such that the
`first coil is configured to orient the first magnetic field in a first
`direction around the first toroid and the second coil is config
`ured to orient the second magnetic field in a second direction
`around the second Solenoid, and wherein the first and second
`directions are opposite. The conduction medium is preferably
`positioned in electrical contact
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`0026 to a portion of an outside surface of the enclosure to
`at least partially restrict the direction of the electric field. In an
`exemplary embodiment, the conduction medium comprises
`an electrically conductive fluid. Such as a solution of electro
`lytes or a conductive gel, housed within the outer enclosure
`and at least
`0027. In another aspect of the invention, a method is pro
`vided for selectively applying energy to a target region within
`a patient. The method includes generating a time-varying
`magnetic field that is located essentially entirely outside of
`the patient and shaping an electric field induced by the mag
`netic field. An electric current from the electric field is con
`ducted through an outer skin Surface of the patient to the target
`region to modulate a nerve at the target region. The target
`region is preferably at least approximately 1-2 cm below the
`outer skin surface and preferably about 2-5 cm below the
`outer skin surface. The electric field is constrained from
`modulating one or more nerves in a second region between
`the outer skin Surface and the target region.
`0028. In one embodiment, the generating step comprises
`generating the time-varying magnetic field within a first
`enclosed coil and generating a second time-varying magnetic
`field within a second enclosed coil positioned near or adjacent
`to the first enclosed coil. In an alternative embodiment, the
`shaping step comprises positioning a conducting medium
`around a portion of the enclosed coil such that the direction of
`the electrical field is constrained within the conducting
`medium. In yet another embodiment, the shaping step com
`prises positioning an electrical insulator around a portion of
`the enclosed coil such that the component of the induced
`electric field normal to the surface of the insulator is zero.
`0029. In another aspect of the present invention, a device
`comprises a source of electrical power, a magnetically per
`meable toroidal core, and a coil that is wound around the core.
`The device also comprises a continuous electrically conduct
`ing medium in which the coil and core are embedded, wherein
`the conducting medium has a shape that conforms to the
`contour of an arbitrarily oriented target body surface of a
`patient when the medium is applied to the target body Surface.
`The source of power Supplies a pulse of electric charge to the
`coil. Such that the coil induces an electric current and/or an
`electric field within the patient, thereby stimulating tissue
`and/or one or more nerve fibers within the patient.
`0030. Because coils of the device produce time-varying
`magnetic fields when time-varying currents are passed
`through the coils, and because the time-varying magnetic
`fields induce an electric current and/or an electric field within
`the patient, the device is known as a magnetic stimulator.
`Because the magnetically permeable cores of the device and
`their corresponding coils are in the shape of a toroid, the
`device is known as a toroidal magnetic stimulator. In one
`aspect of the invention, a toroidal core comprises a high
`permeability material Such as Supermendur, wherein current
`passing through the coil produces a magnetic field within the
`core of about 0.1 to 2 Tesla. Current passing through a coil
`may be about 0.5 to 20 amperes, typically 2 amperes, with
`voltages across each coil of 10 to 100 volts. The current is
`passed through the coils in bursts of pulses. The burst repeats
`at 1 Hz to 5000 Hz, preferably at 15-50 Hz. The pulses have
`duration of 20 to 1000 microseconds, preferably 200 micro
`seconds and there may be 1 to 20 pulses per burst.
`0031. The disclosed invention shapes an elongated electric
`field of effect that can be oriented parallel to a long nerve. In
`a preferred embodiment, the device comprises two toroidal
`
`cores that lie side-by-side one another, around which coils are
`wound. In one embodiment, coils are wound with the same
`handedness around the cores, and current is passed in oppo
`site directions through the coils. In another embodiment, coils
`are wound with the opposite handedness around the cores,
`and current is passed in the same direction through the coils.
`In other embodiments of the invention, the device comprises
`more than two toroids, and the shapes of the toroids may be
`configured to have non-planar or non-circular geometries.
`0032. In one embodiment of the present invention, the
`electrically conducting medium is contained within a cham
`ber having apertures on its Surface that are adapted to dis
`pense the conducting medium through the apertures to the
`target Surface of the patient. In another embodiment, interface
`material is interposed between the conducting medium and
`the target Surface of a patient, Such that the conducting
`medium leaks through the interface to make electrical contact
`with the skin of the patient. For example the interface material
`may be electrically conducting material that is hydrophilic, an
`electrically conducting hydrogel, or a material Such as
`MYLAR(R) having a sub-micron thickness and a high dielec
`tric constant, for example, a dielectric constant of about 3. In
`another embodiment of the invention, the conducting
`medium is contained within a conducting deformable elasto
`meric balloon.
`0033. In one embodiment of the present invention, the
`magnetic stimulator preferably operates to induce an electri
`cal signal within the tissue, where the induced electrical sig
`nal has a frequency between about 1 Hz to 3000 Hz and a
`pulse duration of between about 10-1000 microseconds. By
`way of example, at least one induced electrical signal may be
`of a frequency between about 15 Hz to 35 Hz. By way of
`example, at least one induced electrical signal may have a
`pulsed on-time of between about 50 to 1000 microseconds,
`such as between about 100 to 300 microseconds. The induced
`electrical signal may have any desired waveform, which may
`be one or more of a full or partial sinusoid, a square wave, a
`rectangular wave, and triangle wave.
`0034. In one aspect of the invention, the disclosed device
`is configured to induce a peak pulse Voltage sufficient to
`produce an electric field in the vicinity of a nerve to cause the
`nerve to depolarize and reach a threshold for action potential
`propagation. By way of example, the threshold electric field
`for stimulation of nerve terminals ma