(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2008/0306325 A1
`(43) Pub. Date:
`Dec. 11, 2008
`Burnett et al.
`
`US 200803 06325A1
`
`(54) METHOD AND APPARATUS FOR MAGNETIC
`INDUCTION THERAPY
`
`(75) Inventors:
`
`Daniel R. Burnett, San Francisco,
`CA (US); Christopher
`Hermanson, Santa Cruz, CA (US)
`Correspondence Address:
`Mitchell P. Brook
`LUCE, FORWARD, HAMILTON & SCRIPPS
`LLP
`11988 EL CAMINO REAL SUITE 200
`SAN DIEGO, CA 92130 (US)
`(73) Assignee:
`EMKinetics, Santa Cruz, CA (US)
`(21) Appl. No.:
`11/866,329
`
`(22) Filed:
`
`Oct. 2, 2007
`Related U.S. Application Data
`(60) Provisional application No. 60/848,720, filed on Oct.
`2, 2006.
`
`Publication Classification
`
`(51) Int. Cl.
`(2006.01)
`A6IN 2/02
`(52) U.S. Cl. .......................................................... 6OO/13
`
`ABSTRACT
`(57)
`An energy emittingapparatus for providing a medical therapy
`includes one or more energy generators, a logic controller
`electrically connected to the one or more energy generators,
`and one or more sensors for detecting electric conduction in a
`target nerve that are connected to the logic controller. The one
`or more energy generators produce energy focused on the
`target nerve upon receiving a signal from the logic controller,
`and the energy is varied by the logic controller according to an
`input provided by the one or more sensors. In one embodi
`ment, the energy emitting apparatus is an apparatus for mag
`netic induction therapy that includes one or more conductive
`coils disposed in an ergonomic housing that produce a mag
`netic field focused on the target nerve upon receiving an
`electric current from the logic controller based on an input
`provided by the one or more sensors.
`
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`METHOD AND APPARATUS FOR MAGNETC
`INDUCTION THERAPY
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`0001. The present application claims priority to U.S. Pro
`visional Patent Application Ser. No. 60/848,720, filed on Oct.
`2, 2006 and titled: "Method and Apparatus for Magnetic
`Induction Therapy.”
`
`FIELD OF THE INVENTION
`0002 The present invention relates to energy emitting
`apparatus and methods for providing a medical therapy. In
`one embodiment, the energy emitting apparatus is an ergo
`nomic wrap or cradle that contains conductive coils generat
`ing a magnetic field directed to a target nerve.
`
`BACKGROUND OF THE INVENTION
`0003. Overactive bladder (“OAB) and urinary inconti
`nence (“UI”) affect over 16% of the American population
`each year, or approximately 34 million men and women.
`Outside of the United States, OAB and UI affects over 46
`million Europeans. The economic cost of OAB and UI is
`estimated to be in excess of S12 billion a year in the United
`States alone.
`0004. Due to the social stigmas attached to OAB and UI
`and to misunderstandings related to the symptoms associated
`with OAB and UI, only 40% of the affected individuals in the
`United States seek medical treatment. Of those 13.6 million
`Americans seeking medical treatment, nearly 30% or 4 mil
`lion individuals are reportedly unsatisfied with their current
`therapy.
`0005 Known treatments for OAB and UI include exercise
`and behavioral modifications, pharmacological therapies,
`Surgical intervention and neuromodulation, but each of these
`treatments exhibits severe limitations.
`0006 Exercise and behavioral modifications often require
`patients to adhere to stringent routines, including scheduled
`Voiding, maintenance of a bladder diary, and intense exercise
`regimens. While this type of treatment may be a viable option
`for a small group of highly dedicated individuals, its daily
`impact on a person’s life makes it unattractive for most
`patients.
`0007 Pharmacological intervention is the most widely
`prescribed therapy for OAB and UI. Unfortunately, patients
`often suffer from side effects related to their drug therapies.
`Such side effects are sometimes serious and are particularly
`pronounced in elderly patient populations that tend to use a
`plurality of medications. In addition, approximately 30% of
`all patients subjected to pharmacological therapies appear to
`be dissatisfied with the efficacy of their prescribed treatments.
`0008 Surgical intervention is extremely invasive and
`often results in a long-term requirement for catheterization
`that may become permanent in Some instances. The negative
`impact of these procedures on the patient’s quality of life and
`their high expense make Surgical intervention a recom
`mended option only when all other treatment options have
`been exhausted.
`0009 Neuromodulation is another available therapy for
`OAB and UI. In general, pulsed electromagnetic stimulation
`(“PES) has proven to have beneficial effects in a variety of
`medical applications. The related Scientific principle is that an
`electric current passing through a coil generates an electro
`
`magnetic field, which induces a current within a conductive
`material placed inside the electromagnetic field.
`(0010 More particularly, PES has been shown to be an
`effective method of stimulating a nerve positioned within the
`electromagnetic field, thereby affecting a muscle controlled
`by that nerve. For example, in the paper titled “Contactless
`Nerve Stimulation and Signal Detection by Inductive Trans
`ducer presented at the 1969 Symposium on Application of
`Magnetism in Bioengineering, Maass et al. disclosed that a
`nerve threading the lumen of a toroid could be stimulated by
`a magnetic field of 0.7 Volt peak amplitude and a 50 us
`duration in a monitor wire, and that such stimulation could
`generate a contraction of major leg muscles in anesthetized
`mammals.
`0011
`Various attempts were made in the prior art to use
`PES for treating a variety of ailments. For example, U.S. Pat.
`No. 4.548,208 to Niemi discloses an apparatus for inducing
`bone growth by generating an electric current in the body
`through the external application of an electromagnetic field.
`Such apparatus includes opposing clamps disposed on a limb
`and may optionally include feedback coils and a micropro
`cessor for sensing the magnetic field, so to avoid an overcur
`rent mode. Therefore, this apparatus optimizes the magnetic
`field on the basis of measurements of the generated magnetic
`field.
`0012 U.S. Pat. No. 4,940,453 to Cadwell discloses a
`method and apparatus for magnetically stimulating the neural
`pathways of a higher level organism. In this invention, a
`sinusoidally fluctuating current flow is created through a coil
`that overlies neurons to be stimulated, and frequency of the
`current flow and frequency of the magnetic field produced by
`the coil predetermined to correspond to the time constant of
`the neurons to be stimulated. Sensors for sensing coil condi
`tions, such as coil temperature, may also be included.
`0013 U.S. Pat. No. 5,000, 178 to Griffith discloses an elec
`trical to electromagnetic transducer for applying electromag
`netic energy to damaged parts of a living body by directing
`electromagnetic radiation to a certain damaged body part.
`Electromagnetic radiation is initially generated by a dipole
`consisting of a bar of high permeability material wrapped
`with an electrically conductive coil. Magnetic fields, which
`are generated away from the damaged body part, intersect a
`conductive shield and establish eddy currents, which in turn
`generate magnetic fields opposite and nearly equal to the
`magnetic fields generated by the electromagnetic source. The
`resultant electromagnetic fields reinforce the electromagnetic
`field directed towards the damaged body part and diminish
`the electromagnetic field directed away from the damaged
`body part.
`0014 U.S. Pat. No. 5,014,699 to Pollacket al. discloses a
`non-invasive, portable electromagnetic therapeutic method
`and apparatus for promoting the healing of damaged or dis
`eased living tissue, including fractured bone. These method
`and apparatus involve generating a signal that has a series of
`Substantially symmetric Voltage cycles ofbursted pulses with
`narrow pulse widths of 0.5 to 20 microseconds, and further
`involve converting the signal into an electromagnetic field
`extending into an area that contains tissue to be healed. This
`invention provides for no feedback on the efficiency of the
`applied stimulation.
`0015. In a paper titled “Selective Stimulation and Block
`ing of Sacral Nerves: Research Setup and Preliminary
`Results.” published in Annual International Conference of the
`IEEE Engineering in Medicine and Biology Society, Vol. 13,
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`No. 2, 1991, Wijkstrala et al. used an external pulsed magnetic
`coil to stimulate a peripheral nerve for the treatment of uri
`nary incontinence. The authors used a large magnetic field
`produced by a single coil to ensure that the nerve was fired and
`the resulting nerve conduction was frequently painful or
`intolerable. In addition, coil alignment was problematic
`because an internally implanted coil was utilized, which had
`to be aligned with the fully external magnetic field to stimu
`late the nerve. Due to the difficulty in positioning the device,
`the practical application of this therapy does not permit home
`healthcare usage without a preset alignment and monitoring
`of the nerve, and no provision was made to insure that the
`nerve was actually being stimulated or to adjust the device in
`response to commonly occurring physiologic and anatomic
`variations in nerve locations.
`0016 U.S. Pat. Nos. 5,181,902 Erickson et al. and 5,314,
`401 to Tepper disclose pulsed electromagnetic field
`(“PEMF) transducer systems usable to perform PEMF
`therapies (such as after spinal fusion) by generating flux
`aided electromagnetic fields. The drive electronics includes a
`PEMF processor that executes a PEMF program for control
`ling the activation of the electromagnetic fields (field strength
`and cycle).
`0017. In a paper titled: “Magnetic Stimulation of the Blad
`der in Dogs’ presented at the 1993 AAEM Annual Meeting,
`the abstract of which was published in the Muscle & Nerve
`issue of October 1993, Lin et al. disclosed that magnetic
`stimulation could be employed to stimulate the cortex, spinal
`nerves and peripheral nerves of dogs through direct trans
`abdominal stimulation of the detrusor muscles or through
`stimulation of the lumbosacral roots.
`0018. As shown, the prior art makes no provision to mea
`sure the efficacy of PES treatment, causing patients to be
`treated improperly, either by an insufficient or excessive
`exposure to PES. Other attempts to monitor PES dosage in the
`prior art exhibit serious drawbacks. For example, U.S. Pat.
`No. 5.518,495 to Kot discloses an apparatus for the treatment
`of arthritis utilizing a magnetic field therapy, which includes
`an adjustable Voltage source that is connected to a source of
`line Voltage and a coil connected to the adjustable Voltage
`Source. This apparatus has no feedback system to advise a
`healthcare provider of the efficiency of the treatment.
`00.19
`U.S. Pat. No. 5,984.854 to Ishikawa et al. discloses
`a method for treating urinary incontinence based on deliver
`ing a train of current pulses through one or more magnetic
`stimulation coils so to induce a train of magnetic flux pulses,
`which then induce an eddy current within the body and stimu
`lates a group of pelvic floor muscles, the pudendal nerve, the
`external urethral sphincter, or the tibial nerve. While this
`method includes the use of pulsed electromagnetic for treat
`ing urinary incontinence, no specific components are envi
`Sioned to facilitate the placement of the magnetic coils over a
`targeted region of the body or a system for monitoring the
`efficiency of the therapy being applied.
`0020 U.S. Pat. No. 6,086,525 to Davey et al. discloses a
`magnetic nerve stimulator that includes a core constructed
`from a material having a high field Saturation having a coil
`winding disposed thereon. A thyrister capacitive discharge
`circuit pulses the device, and a rapidly changing magnetic
`field is guided by the core, preferably made from vanadium
`permendur.
`0021 U.S. Pat. No. 6,701,185 to Burnett et al. also dis
`closes an electromagnetic stimulation device that includes a
`plurality of overlapping coils, which can be independently
`
`energized in a predetermined sequence Such that each coil
`will generate its own independent electromagnetic field and
`significantly increase the adjacent field. Unfortunately, none
`of these patents provides a system for monitoring the effi
`ciency of the therapy in progress, either with respect to the
`proper positioning of the winding over the area to be treated
`or of the intensity of the magnetic field to be applied.
`0022. Other PES therapies require the implantation of
`devices into the patient, with the consequent discomfort, risk
`and cost to the patient. For example, U.S. Pat. No. 6,735,474
`to Loeb et al. discloses a method and system for treating UI
`and/or pelvic pain by injecting or laparoscopically implanting
`one or more battery- or radio frequency-powered microstimu
`lators that include electrodes placed beneath the skin of the
`perineum and/or adjacent the tibial nerve.
`0023 U.S. Pat. No. 6,941,171 to Mann et al. describes a
`method and a system for treating incontinence, urgency, fre
`quency, and/or pelvic pain that includes implantation of elec
`trodes on a lead or a discharge portion of a catheter adjacent
`the perineal nerves) or tissue(s) to be stimulated. Stimulation
`pulses, either electrical or drug infusion pulses, are Supplied
`by a stimulator implanted remotely through the lead or cath
`eter, which is tunneled subcutaneously between the stimula
`tor and stimulation site.
`(0024. Other PES therapies in the prior art involve the use
`of electrodes placedonor beneath the skin of a patient. Recent
`data on invasive, needle-based PES of the posterior tibial
`nerve in individuals with OAB and UI indicates that PES can
`modulate bladder dysfunction through its action on the
`pudendal nerve and the Sacral plexus, which provide the
`major excitatory input to the bladder.
`(0025. In a paper titled “Percutaneous Tibial Nerve Stimu
`lation via Urgent(R) PC Neuromodulation System. An
`Emerging Technology for managing Overactive Bladder.”
`which was published in Business Briefing: Global Surgery
`2004, CystoMedix, Inc. disclosed that peripheral tibial nerve
`stimulation (“PTNS) had been found effective in treating
`OAB. The disclosed procedure involved the use of electrode
`and generator components, including a small 34-gauge
`needle electrode, lead wires and a hand-held electrical gen
`erator. However, the procedure requires the permanent
`implantation of an electrical stimulation device in the patient.
`One estimate put the cost of treatment at nearly $14,000 with
`additional routine care costs of S593 per patient per year.
`Additionally, risks of battery failure, implant infection, and
`electrode migration led to a high re-operation rate and made
`this procedure unattractive.
`(0026 U.S. Pat. No. 7,117,034 to Kronberg discloses a
`method for generating an electrical signal for use in biomedi
`cal applications that includes two timing-interval generators.
`In this invention, skin-contact electrodes may be placed over
`an area of interestanda microprocessor may direct timing and
`sequencing functions, although Such timing and sequencing
`functions are not related to the actual efficacy of the treatment
`while treatment is being performed.
`(0027 U.S. Patent Application Publication No. 2005/
`0171576 to Williams et al. discloses an electro-nerve stimu
`lation apparatus that includes a pulse generator, a first elec
`trically conductive, insulated lead wire, a second electrically
`conductive, insulated lead wire, an electrically conductive
`transcutaneous electrode and an electrically conductive per
`cutaneous needle electrode. Connected to one end of the first
`and second lead wires is a connector for electrically coupling
`with the pulse generator. In this invention, a percutaneous
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`needle electrode is inserted through the skin in proximity to
`the desired internal stimulation site and electric stimulation is
`employed, rather than pulsed electromagnetic stimulation.
`Moreover, the Williams invention does not contemplate
`mechanisms for facilitating use of the device by an untrained
`user, nor a monitoring of the applied therapy.
`0028. A neuromodulation alternative is a posterior tibial
`nervestimulator, often referred to as SANS, but as is the case
`with other forms of neuromodulation, this procedure is inva
`sive in nature and requires the insertion of a needle five
`centimeters into the patient's ankle region to stimulate the
`posterior tibial nerve. This procedure also requires a mini
`mum of twelve sessions for initial treatment, possibly with
`additional sessions required for maintenance.
`
`SUMMARY OF THE INVENTION
`0029. It is an object of the present invention to provide
`apparatus and methods for magnetic induction therapy, in
`which dosage of magnetic energy can be regulated according
`conduction in a target nerve exposed to the magnetic field.
`0030. It is another object of the present invention to pro
`vide apparatus and methods for magnetic induction therapy,
`in which the flow of magnetic energy can be adjusted direc
`tionally by the patient or a healthcare provider without alter
`ing the position of a housing containing conductive coils that
`produce the magnetic field.
`0031. It is a further object of the present invention to
`provide apparatus and methods for treating a variety of ail
`ments by providing energy to a target nerve, for example
`magnetic energy, electrical energy or ultrasound energy, at a
`location and in an amount optimized by detecting conduction
`in the target nerve.
`0032. These and other objects of the present invention are
`achieved by providing an energy emitting apparatus for deliv
`ering a medical therapy that includes one or more energy
`generators, a logic controller electrically connected to the one
`or more energy generators, and one or more sensors for
`detecting electric conduction in a target nerve, which are
`connected to the logic controller. The one or more energy
`generators produce energy focused on the target nerve upon
`receiving a signal from the logic controller, and the applied
`energy is varied by the logic controller according to an input
`provided by the one or more sensors based on electric con
`duction in the target nerve. The feedback provided by the
`sensors to the logic controller about the efficacy of the applied
`treatment causes the logic controller to modulate the current
`transmitted to the coils.
`0033. The applied energy may be a magnetic field, an
`electrical field, an ultrasound, a visible light, or an infrared or
`an ultraviolet energy. When a magnetic field is applied, the
`energy-emitting device is an apparatus that provides a mag
`netic induction therapy and that includes one or more con
`ductive coils disposed in an ergonomic housing. A logic con
`troller is electrically connected to the one or more coils, and
`one or more sensors detect electric conduction in the target
`nerve and are connected to the logic controller so to provide
`a feedback to the logic controller. The conductive coils
`receive an electric current from the logic controller and pro
`duce a magnetic field focused on a target nerve, and the
`electric current fed by the logic controller is varied by the
`logic controller according to an input provided by the sensors,
`thereby causing amplitude, frequency or direction of the mag
`netic field, or the firing sequence of the one or more coils, to
`be varied according to the efficiency of the treatment provided
`
`to the target nerve. In different embodiments of the invention,
`the housing containing the conductive coils may be a flexible
`wrap, a cradle or a garment, and the coils may be overlapping
`and/or be disposed in different positions within the housing,
`so to generate a magnetic field on different body parts with the
`desired direction and amplitude.
`0034. The one or more coils may be stationary or movable
`within the housing, making it possible to optimize the direc
`tion of magnetic flow to the target nerve by disposing the coils
`in the most effective direction. In different embodiments, the
`coils may be movable manually by acting on a knob, lever, or
`similar type of actuator, or may be translated automatically by
`the logic controller in response to the input provided by the
`sensors. When a preferred position for the coils has been
`established, the coils may be locked in position and maintain
`that position during Successive therapy sessions. In other
`embodiments, the sensors may be incorporated within the
`housing, or instead may be disposed on a body part of interest
`independently of the housing.
`0035. In still other embodiments of the invention, the
`inductive coils are disposed in a housing that is situated
`externally to a patient's body, and additional inductive coils
`are implanted into the body of the patient and are magneti
`cally coupled to the external inductive coils. With this coil
`arrangement, energy may be transmitted from the external
`coils to the internal coils either to recharge or to activate an
`implantable device. In yet other embodiments of the inven
`tion, the electric current may varied by the logic controller
`both on the basis of an input provided by the one or more
`sensors and also an input provided by the patient according to
`a muscular response she has perceived, for example, the
`twitching of a toe after application of the magnetic field.
`0036. In yet other embodiments of the invention, the
`Source of energy for nerve stimulation may be electrical
`energy and nerve conduction may be detected at a site suffi
`ciently distant from the site of stimulation, so to enable detec
`tion of nerve conduction despite the confounding interference
`from the direct electrical stimuli. In these embodiments,
`direct electrical stimulation of nerve and muscle may be
`tailored to provide optimal therapy and, in the case of elec
`trode migration or other electrode malfunction, to report lack
`of stimulation of the bodily tissues. Furthermore, these
`embodiments enable a reduction in power requirement,
`because control of the signal is provided by the sensor to the
`signal generator loop.
`0037 Methods of use of the above apparatus are also
`described herein.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0038. The drawings constitute a part of this specification
`and include exemplary embodiments of the invention, which
`may be embodied in various forms. It is to be understood that
`in some instances various aspects of the invention may be
`shown exaggerated or enlarged to facilitate an understanding
`of the invention.
`0039 FIG. 1 is a schematic view of an apparatus for mag
`netic induction therapy according to a first embodiment of the
`invention.
`0040 FIG. 2 is a schematic view of an apparatus for mag
`netic induction therapy according to a second embodiment of
`the invention.
`0041
`FIG. 3 is a schematic view of an apparatus for mag
`netic induction therapy according to a third embodiment of
`the invention.
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`0042 FIG. 4 is a schematic view of an apparatus for mag
`netic induction therapy according to a fourth embodiment of
`the invention.
`0043 FIG. 5 is a schematic view of an apparatus for mag
`netic induction therapy according to a fifth embodiment of the
`invention.
`0044 FIGS. 6A-6D are schematic illustrations depicting a
`first method of use of an apparatus for magnetic induction
`therapy. This method is based on adjusting the position of the
`conductive coils so to optimize a magnetic flow applied to a
`target nerve.
`004.5 FIGS. 7A-7D are schematic illustrations of a second
`methodofuse of an apparatus for magnetic induction therapy.
`This method is based on locking the conductive coils in
`position once electrical conduction in a target nerve has been
`detected.
`0046 FIG. 8 is a schematic view of an embodiment of the
`invention that includes a plurality of sensors.
`0047 FIGS. 9A-9D are schematic representations of dif
`ferent garments adapted to operate as apparatus for magnetic
`induction therapy according to the principles of the present
`invention.
`
`DETAILED DESCRIPTION OF EMBODIMENTS
`OF THE INVENTION
`0048 Detailed descriptions of embodiments of the inven
`tion are provided herein. It is to be understood, however, that
`the present invention may be embodied in various forms.
`Therefore, the specific details disclosed herein are not to be
`interpreted as limiting, but rather as a representative basis for
`teaching one skilled in the art how to employ the present
`invention in virtually any detailed system, structure, or man
`.
`0049 Referring first to FIG. 1, a first embodiment of the
`invention includes a coil wrap 20, which is depicted as dis
`posed over ankle 22 circumferentially to surround a portion of
`tibial nerve 24. Because tibial nerve 24 is targeted, this
`embodiment is particularly suited for the treatment of OAB
`and UI. In other embodiments of the invention, coil wrap 20
`may be configured to Surround other body parts that contain a
`portion of tibial nerve 24 or of other nerves branching from or
`connected to tibial nerve 24, still making these embodiments
`suitable for treating OAB and UI. In still other embodiments
`of the invention, coil wrap 20 may be configured for sur
`rounding body parts that contain other nerves when treat
`ments of other ailments are intended.
`0050 Coil wrap 20 may be manufactured from a variety of
`materials suitable for wearing over ankle 22. Preferably, coil
`wrap is produced from a soft, body-compatible material,
`natural or synthetic, for example, cotton, wool, polyester,
`rayon, Gore-Tex , or other fibers or materials known to a
`person skilled in the art as non-irritating and preferably
`breathable when tailored into a garment. Coil wrap 22 may
`even be manufactured from a molded or cast synthetic mate
`rial. Such as a urethanegel, to add extra comfort to the patient
`by providing a soft and drapable feel. Additionally, coil wrap
`20 may be produced from a single layer of material or from
`multiple material layers and may include padding or other
`filling between the layers.
`0051 Coil wrap 20 contains one or more conductive coils
`26 arranged to produce a pulsed magnetic field that will flow
`across tibial nerve 24 and generate a current that will flow
`along tibial nerve 24 and spread along the length of tibial
`nerve 24 all the way to its sacral or pudendal nerve root
`
`origins. Coils 26 may be a single coil shaped in a simple
`helical pattern or as a figure eight coil, a four leaf clover coil,
`a Helmholtz coil, a modified Helmholtz coil, or may be
`shaped as a combination of the aforementioned coils patterns.
`Additionally, other coil designs beyond those mentioned
`hereinabove might be utilized as long as a magnetic field is
`developed that will encompass tibial nerve 24 or any other
`target nerve. When a plurality of coils is utilized, such coils
`may be disposed on a single side of ankle 22, or may be
`disposed on more than one side, for example, on opposing
`sides, strengthening and directionalizing the flow of the mag
`netic field through tibial nerve 24 or other peripheral nerves of
`interest.
`Coil wrap 20 is preferably configured as an ergo
`0.052
`nomic wrap, for example, as an essentially cylindrical band
`that can be pulled over ankle 22, or as an open band that can
`be wrapped around ankle 22 and have its ends connected with
`a buckle, a hoop and loop system, or any other closing system
`known to a person skilled in the art. By properly adjusting the
`position of coil wrap 20 over ankle 22, a patient or a health
`care provider may optimize the flow of the magnetic field
`through tibial nerve 24, based on system feedback or on
`sensory perceptions of the patient, as described in greater
`detail below.
`0053. The electric current that produces the magnetic field
`by flowing through coils 26 is Supplied by a programmable
`logic controller 28, which is connected to coils 26, for
`example, with a power cord 32. A sensor 30 that feeds infor
`mation to logic controller 28 is also provided, in order to tailor
`the strength of the magnetic field and control activation of
`coils 26 based on nerve conduction. The purpose of sensor 30
`is to detect and record the firing of the target nerve and to
`provide related information to logic controller 28, so to render
`the intended therapy most effective. For example, sensor
`input may cause logic controller 28 to alter the strength or
`pulse amplitude of the magnetic field based on sensor input,
`or fire the coils in a certain sequence.
`0054. In this embodiment, as well as in the other embodi
`ments described hereinafter, sensor 30 may include one or
`more sensor patches and may be placed at different distances
`from the region of direct exposure to the magnetic field. For
`example, sensor 30 may be configured as a Voltage or current
`detector in the form of an EKG patch and may be placed
`anywhere in the vicinity of the target nerve to detect its
`activation. For ease of description, the term "coils” will be
`used hereinafter to indicate "one or more coils” and “sensor'
`to indicate "one or more sensors, unless specified otherwise.
`0055. By virtue of the above described arrangement, coil
`wrap 20 provides a reproducibly correct level of stimulation
`during an initial therapy session and during Successive
`therapy sessions, because the presence or absence of nerve
`conduction is detected and, in Some embodiments, measured
`when coil wrap 20 is first fitted and fine-tuned on the patient.
`In addition to properly modulating the applied magnetic field,
`the positioning of coils 26 over ankle 22 may also be tailored
`according to the input provided by sensor 30, so to fine-tune
`the direction of the magnetic field. Such an adjustment of the
`direction, amplitude, and level of the stimulation provided to
`the target nerve through the above described automated feed
`back loop, to ensure that peripheral nerve conduction is being
`achieved, is one of the key features in the present invention.
`0056. If the magnetic pulse does not substantially interfere
`with sensor 30, sensor 30 may be placed directly within the
`field of stimulation, so that power Supplied to the system may
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`US 2008/0306325 A1
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`Dec. 11, 2008
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`be conserved. This is particularly important for battery-pow
`ered systems. Alternatively, sensor 30 may also be placed at a
`distance from the magnetic field and still properly detect
`neural stimulation.
`0057. In a method of use of coil wrap 20, the amplitude
`and/or firing sequence of coils 26 may be ramped up progres
`sively, so that the magnetic field is increased in strength
`and/or breadth until nerve conduction is detected, after which
`the applied stimulus is adjusted or maintained at its current
`level for the remainder of the therapy. The level of stimulation
`may be also controlled through a combination of feedback
`from sensor 30 and feedback based on perceptions of the
`patient. For example, the patient may activate a Switch once
`she perceives an excessive stimulation, in particular, an
`excessive level of muscular stimulation. In one instance, the
`patient may be asked to push a button or turn a knob when she
`feels her toe twitching or when she experienc