(12) United States Patent
`Burnett et al.
`
`USOO6701 185B2
`(10) Patent No.:
`US 6,701,185 B2
`(45) Date of Patent:
`Mar. 2, 2004
`
`(54) METHOD AND APPARATUS FOR
`ELECTROMAGNETIC STIMULATION OF
`NERVE, MUSCLE, AND BODY TISSUES
`
`(76) Inventors: Daniel Burnett, 12565 Long Lake Ct.,
`Jacksonville, FL (US) 32225; Shane
`Mangrum, 3701 Danforth Dr. #908,
`
`6,143,035 A 11/2000 McDowell
`6,155,966 A 12/2000 Parker
`6,179,770 B1
`1/2001 Mould
`6,190,893 B1
`2/2001 Shastri
`6,200.259 B1
`3/2001 March
`6,261,221 B1 * 7/2001 Tepper et al. ................. 600/14
`6,349.233 B1
`2/2002 Adams
`
`(*) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 74 days.
`
`Trock, David H., et al, The Effect of Pulsed Electromagnetic
`Fields in the Treatment of Osteoarthritis of the Knee and
`Cervical Spine. Report of Randomized, Double Blind, Pla
`cebo Controlled Trials, The Journal of Rheumatology, 1994,
`p. 1903–1911.
`Trock, David H., E.Lectromagnetic Fields and Magnets
`Investigational Treatment for Musculoskeletal Disorders,
`Rheumatic Diseases Clinics of North America, Feb. 2000,
`vol. 26, No. 1.
`(List continued on next page.)
`
`Primary Examiner Mark Bockelman
`(74) Attorney, Agent, or Firm Maine & Asmus
`(57)
`ABSTRACT
`An electromagnetic stimulation device which is comprised
`of a plurality of overlapping coils which are able to be
`independently energized in a predetermined sequence Such
`that each coil will generate its own independent electromag
`netic field and Significantly increase the adjacent field. The
`coils are co-planar and are disposed in an ergonomic body
`hich i
`1
`ked
`killed
`wrap, which is properly marked to permit an unskille
`patient to locate the body wrap, on a particular part of the
`body, of the patient So that the stimulation coils will maxi
`mize the electromagnetic Stimulation on the Selected nerves,
`muscles, and/or body tissues near the treated area. The
`device can be used to treat medical conditions including:
`muscular atrophy, neuropathic bladder and bowel, muscu
`loskeletal pain, arthritis, as well as possible future applica
`to the prevention of deep vein thrombosis and weight
`
`10 Claims, 3 Drawing Sheets
`
`(56)
`
`(21) Appl. No.: 10/077,434
`(22) Filed:
`Feb. 19, 2002
`(65)
`Prior Publication Data
`US 2003/0158583 A1 Aug. 21, 2003
`(51) Int. Cl." .................................................. A61N 1100
`(52) U.S. Cl. ............................ 607/2; 607/149; 607/155
`(58) Field of Search ................................. 600/9, 13-15;
`607/2, 48, 50, 149, 155
`References Cited
`U.S. PATENT DOCUMENTS
`4,428,366 A
`1/1984 Findl
`4,456,012 A 6/1984 Latin
`4,548,208 A 10/1985 Niemi
`5,000,178 A 3/1991 Griffith
`5,014,699 A 5/1991 Pollack
`5,181,902 A 1/1993 Erickson
`5,314,401 A 5/1994 Tepper
`5,401.233 A 3/1995 Erickson
`5,518.495 A 5/1996 Kolt
`5,766,124 A 6/1998 Polson
`5,792,187 A
`8/1998 Adams
`5,857,957 A
`1/1999 Lin
`CE A 3.2. E.
`6,032,677 A 3/2000 Blechman
`6,066,084 A 5/2000 Edrich
`6,086.525 A 7/2000 Davey
`6,123,658 A 9/2000 Schweighofer
`
`2Y- 1 - 2
`
`es
`
`
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`OTHER PUBLICATIONS
`Shafik, Ahmed, Magnetic Stimulation: A Novel Method for
`Inducing Evacuation of the Neuropathic Rectum and Uri
`nary Bladder in a Canine Model, Urology 54, 1999, pp.
`368-372.
`Balmaseda, Marion T. Jr., et al, Burns in Functional Electric
`Stimulation: Two Case Reports, Archives of Physical Medi
`cine and Rehabilitation, Jul. 1987, pp. 452-453, vol. 38.
`McFarlane, J.P. etal, Acute Suppression of Idiopathic Detru
`sor Instability with Magnetic Stimulation of the Sacral
`Nerve Roots, British Journal of Urology, 1997, pp. 734–741,
`vol. 80.
`
`Jacobson, Jerry I. et al., Low-Amplitude, Extremely Low
`Frequency Magnetic Fields for the Treatment of Osteoar
`thritic Knees: A Double-Blind Clinical Study, Alternative
`Therapies, Sept./Oct. 2001, pp. 54-64, vol. 7, No. 5.
`EBI, L.P., EBI BONE HEALING SYSTEM, http://www.e-
`bimedical.com/products/fracture/bonehealing.html, 5 pages.
`Certified Pulsed Signal Therapy Centers, http://www.certi
`fiedpSt.com, 10 pages.
`
`* cited by examiner
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`1
`METHOD AND APPARATUS FOR
`ELECTROMAGNETIC STIMULATION OF
`NERVE, MUSCLE, AND BODY TISSUES
`
`FIELD OF THE INVENTION
`The present invention relates to the field of medical
`devices, in particular electromagnetic Stimulating devices
`for Stimulation of nerve, muscle, and/or other body tissues
`with applications in the field of medicine.
`SUMMARY OF THE INVENTION
`The instant invention is drawn to an electromagnetic
`Stimulating device able to provide Stimulation to tissues of
`the human body, including nerves, muscles (including Super
`ficial and deep muscles), and/or other body tissues without
`Significant discomfort to the patient. This electromagnetic
`Stimulating device utilizes a plurality of overlapping planar
`coils encased in an ergonomic, body-contoured wrap. The
`design of the wrap is intended to allow for ease of use and
`also for the targeting of anatomic regions to be exposed to
`the impulses of the electromagnetic fields.
`The device of the present invention provides an electro
`magnetic field to Stimulate underlying body tissues in a
`manner necessary for the Several applications including: the
`prevention/treatment of muscular atrophy, the treatment of
`neurogenic bladder and bowel, the treatment of musculosk
`eletal pain, the treatment of arthritis, and/or muscular aug
`mentation. The plurality of Overlapping coils are placed in
`an ergonomic wrap So as to blanket the designated thera
`peutic area, and thereby provide consistent therapy that can
`be quickly and easily administered. The invention is
`designed to be patient user friendly as well as to be portable.
`It can be used in a hospital, an outpatient clinic, a therapists
`office, or even at a patient's home.
`It is an object of the present invention to provide an
`electromagnetic device for Stimulating regions of the body,
`which has overlapping coils which can be fired Sequentially
`or in unison depending on the particular required treatment
`conditions requiring both maximal stimulation (Sufficient to
`cause contraction of muscle fibers) as well as Submaximal
`stimulation (which will be sufficient to provide therapy but
`not to cause contraction of muscle fibers). The applications
`of the device can be divided into maximal and Submaximal
`categories, in which the former requires significantly higher
`levels of inducting current than the latter. The maximal
`applications of the device include: one, non-invasive Stimu
`lation of the peripheral nervous System; two, treatment
`and/or prevention of atrophy (as would be therapeutic during
`recovery after a perSons Sustains a fracture, experiences
`paralysis of a limb or other body part, or undergoes Surgery,
`Such as ACL repair in the knee; and three, treatment of
`neurogenic bladder and bowel. Submaximal applications of
`the device include: one, treatment of musculoskeletal pain
`(e.g. back and neck pain, muscle spasms, and other forms of
`muscle or skeletal related pain); and two, treatment of
`arthritis.
`It is an object of the invention to provide a device for the
`electromagnetic Stimulation of Selective anatomic regions of
`the body, utilizing an ergonomic wrap to facilitate accurate
`and targeted placement of the device for the Stimulation of
`key nerves, muscles, and/or body tissues.
`It is an object of the invention to provide a device to
`electromagnetically Stimulate Selective nerves muscles, and/
`or body tissues that is user friendly and capable of being
`used even by an unskilled patient in a home healthcare
`Setting.
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`It is an object of the invention to provide a device to
`electromagnetically Stimulate Selective nerves, muscles, and
`body tissues to provide consistent therapy, with the ergo
`nomic wrap targeting key nerves and eliminating the
`requirement for a highly trained operator to manipulate the
`device.
`
`BACKGROUND OF THE INVENTION AND
`DESCRIPTION OF THE PRIOR ART
`The concept of pulsed electromagnetic Stimulation was
`first observed by the renowned scientist Michael Faraday in
`1831. Faraday was able to demonstrate that time varying, or
`pulsed electromagnetic fields have the potential to induce
`current in a conductive object. Faraday's experimental Setup
`was simple. He found that by passing Strong electric current
`through a coil of wire he was able to produce pulsed
`electromagnetic Stimuli. This pulsed electromagnetic Stimu
`lus was able to induce the flow of current in a nearby
`electrically conductive body.
`In the years Since the discoveries of Faraday, pulsed
`electromagnetic Stimulators have found application in
`countleSS areas of Scientific investigation. In 1965, the
`Scientists Bickford and Freming demonstrated the use of
`electromagnetic Stimulation to induce conduction within
`nerves of the face. Later, in 1982 Polson et al., U.S. Pat. No.
`5,766,124 produced a device capable of Stimulating periph
`eral nerves of the body. This device was able to stimulate
`peripheral nerves of the body Sufficiently to cause muscle
`activity, recording the first evoked potentials from electro
`magnetic Stimulation.
`The ability of pulsed electromagnetic Stimulation to
`induce electrical currents within tissueS of the human body
`has prompted medical research in recent years with respect
`to the diagnosis, monitoring, and therapy of a variety of
`important conditions.
`Electrical Stimulation is a related technology that has been
`employed for man of years in the treatment of numerous
`medical conditions. One of the most commonly used for of
`electrical Stimulation takes the form of what is known as
`TENS (Transcutaneous Electrical Nerve Stimulation) unit.
`These devices are designed specifically to Stimulate nerve
`tissue that will block or interrupt pain Signals being Sent to
`the brain.
`This class of electrical Stimulating devices utilizes the
`principles of direct nerve Stimulation to excite nerves. These
`technologies place electrodes directly on the skin or on
`occasions beneath the Skin in a Surgically implanted fashion.
`The electrodes carry wires, through which electrons flow
`and create a transfer of charge to the tissues and nerve cells
`beneath.
`Electrical Stimulation can be effective in Stimulating
`Superficial tissues, as Stimulation is usually accomplished
`from Small electrodes, with moderate Voltage and current
`levels. Electrical Stimulation, however, can cause significant
`skin irritation and burns as has been reported in a significant
`number of cases within the medical literature (Balmmaseda
`MT, et al. Burns in functional electric stimulation. Archives
`of Physical Medicine and Rehabilitation. July 1987; 68(7)
`452-53). In its alternative forms, such as with surgically
`implanted electrodes, electrical Stimulation can be invasive
`and consequently associated with adverse side effects. The
`difficulties with electrical Stimulation become especially
`Significant as large excitation levels are required for more
`complete Stimulation of nerves.
`The limitations of electrical Stimulation have prompted
`investigations into the possible applications of pulsed elec
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`tromagnetic Stimulation. The basic principal behind the
`concept of electromagnetic Stimulation is that an electric
`current pulsed, or passed through a coil winding structure
`will generate an electromagnetic field. An electromagnetic
`field can, in turn, generate a current in any conductive
`material, Such as nerves or other body tissues, within this
`field.
`The electromagnetically induced electric field created by
`properly oriented pulsed electromagnetic Stimulation thus
`accomplishes the result of transferring charge to cells of the
`body. This transferred charge can lead to nerve firing,
`muscle contraction, Stimulation of cell Signaling pathways
`causing cell growth, and a number of other effects.
`In contrast to applications of electrical Stimulation, pulsed
`electromagnetic Stimulation does not require direct skin
`contact to induce nerve excitation. As a result, Significantly
`higher levels of directed Stimulation can be achieved though
`pulsed electromagnetic Stimulation without the adverse
`effects of other technologies.
`The ability of electromagnetic Stimulation to induce elec
`trical currents within tissueS of the human body has
`prompted medical research in recent years with respect to
`the diagnosis, monitoring, and therapy of a variety of
`conditions, including: preventing and treating muscle
`atrophy, treating neurogenic bowel and bladder, offering
`pain control for musculoskeletal and back pain, and treating
`arthritis.
`The device of the present invention is a powerful elec
`tromagnetic Stimulating device created for the purpose of
`Stimulating nerve, muscle, and/or other body tissues. The
`device builds on existing electromagnetic Stimulator tech
`nology to provide an easy-to-use, ergonomically designed
`system that will have applications within a host of clinical
`and home ease of use health applications.
`One of the earliest applications of electromagnetic Stimu
`lating technology took the form of bone growth Stimulators.
`These devices employ low frequency pulsed electromag
`netic fields to Stimulate bone repair. Bone growth Stimula
`tors first found use approximately 20 years ago in the
`treatment of non-healing fractures, and are Slowly becoming
`the Standard of care for this condition.
`AS investigators have Studied the effects of electromag
`netic fields on fracture healing, it has been demonstrated that
`low frequency pulsed electromagnetic fields can not only
`facilitate fracture healing but also cause the growth of
`cartilage cells (Rheumatic Diseases Clinics of North
`America, 26(1):51–63, February 2000). This ability to
`Stimulate new cartilage growth creates a tremendous poten
`tial for treating arthritis.
`The effects electromagnetic fields on the repair of carti
`lage and Soft fibrous tissues have been demonstrated in a
`number of recent Studies. Pulsed electromagnetic devices
`have been shown to be effective in treating patients with
`chronic knee arthritis, demonstrating that this treatment
`effective in the reducing pain and improving function.
`(Rheumatic Diseases of Clinics of North America, 26(1)
`52–63, February 2000).
`Not only has electromagnetic Stimulation been shown to
`improve repair of cartilage and Soft tissues, it has also been
`shown to be Safe and cost-effective for treating patients with
`chronic knee pain due to arthritis (Altern Ther Health Med,
`7(5):54–64, September-October 2001). The treatment has
`not been demonstrated to have any Side effects and may be
`useful in forestalling joint replacements.
`The present invention also provides a simple, noninvasive
`Solution to the problem of neuropathic bladder and rectum,
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`Such as perSons with Spinal cord injuries or Multiple Scle
`rosis might experience. Just as these perSons may have
`paralysis of the arms or legs, they can also have a So-called
`“paralysis” of the bladder and bowel, with associated diffi
`culty emptying the bladder and bowels. Complications that
`can arise from neurogenic bladder and bowel are significant.
`In mortality Studies of perSons with Spinal cord injuries, after
`a period of high mortality at the time Surrounding the initial
`injury, neurogenic bladder has been shown to be the primary
`cause of death among perSons with Spinal cord injuries.
`Invasive methods have been attempted to address this
`problem but without Significant Success. In animal models
`electromagnetic Stimulation has been shown to increase
`bladder and bowel pressures, and to thereby effect evacua
`tion (Urology, 54(2) 368-72, August 1999). This technique
`is simple, Safe, noninvasive, and has no known adverse
`effects.
`The present invention also provides a treatment for one of
`the major causes of StreSS urinary incontinence-a condition
`referred to as idiopathic detrusor instability. Detrusor insta
`bility describes the unstable contractions of the detrusor
`muscle (a muscle controlling the release of urine from the
`bladder), which can cause persons to lose, or be incontinent
`of urine. Studies have shown that electromagnetic Stimula
`tion of Sacral (an area of the lower spine) nerve roots acutely
`abolishes unstable contractions in patients with this condi
`tion (British Journal of Urology, 80(5):734-41, November
`1997).
`The prior art devices provide electromagnetic Stimulators,
`which utilize pulse electromagnetic fields to promote posi
`tive effects on the human body. These effects have been
`well-established in multiple large, double-blind, placebo
`controlled studies in the medical literature. The device of the
`present invention Substantially improves the State-of-the-art
`electromagnetic Stimulation technology and incorporates it
`into a user-friendly, body-contoured applicator with multiple
`overlapping coils to effectively carpet the entire targeted
`Subcutaneous region.
`Considered as a group, existing electromagnetic Stimula
`tors cannot be operated by the patient but require a skilled
`technician. These devices employ a single, focused coil of
`varying configurations to provide electromagnetic induc
`tion. While this may be practical for diagnostic purposes, it
`is not user friendly or cost-effective for the treatment of
`muscle atrophy, neurogenic bladder and bowel, musculosk
`eletal pain, arthritis, and a host of other conditions.
`There have been limited attempts in the prior art to solve
`the existing problems associated with the use of electromag
`netic Stimulation devices. One Such example of electromag
`netic stimulation is described in U.S. Pat. No. 6,086,525
`issued to Davey et al. Davey discloses a device that has a
`single coil in the shape of a “C” where the intensity of the
`electromagnetic field is between the ends of the “C”. That
`point must be employed directly over the target nerve or
`muscle to be Stimulated. The coil is toroidal in configuration
`and utilizes a unique core of Vanadium permendur in the
`preferred form. One of the disadvantages of this device is
`that it requires a trained technician to treat the patient and to
`properly hand hold the open end of the “C” over the targeted
`nerve or muscle to be stimulated. The device is not portable
`and is designed for use in hospitals or Similar institutions.
`Also the Vanadium permendur core is required to increase
`the Strength of the electromagnetic field to be strong enough
`to be effectively used. The design, shape and configuration
`described in Davey and other prior art devices, require the
`electromagnetic Stimulator to be hand operated during use.
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`Further, Davey is specifically designed to discourage
`Secondary Stimulation Sites. It is intended to focus and
`concentrate the field to a single point. However, for thera
`peutic use the nerves and muscles that need Stimulation are
`not located at a singe point but in a larger area and hence the
`focus of the field needs to radiate to a larger area and not be
`isolated to a single point. In fact Secondary muscle Stimu
`lation is necessary for proper treatment in many applica
`tions.
`The present invention eliminates the need to have a
`trained technician conduct the electromagnetic Stimulation
`by providing an ergonomic wrap that encases the Overlap
`ping coils. The wrap with reference indica is designed to
`enable an unskilled patient to properly place the wrap Such
`that the proper key nerves, muscles, and/or other body
`tissues are Stimulated A trained physician will prescribe the
`planned degree of electromagnetic Stimulation required,
`both in time and intensity.
`The use of a Solid core is also required in Davey to
`generated Sufficient electromagnetic field intensity to Stimu
`late the nerves, muscles, and/or other body tissues. The
`Present invention overcomes the need for a solid core by
`providing overlapping coils that electrically amplify the
`intensity of the electromagnetic field So as to Stimulate the
`nerves, muscles, and/or other body tissues. Also since no
`Solid core is required in the present invention the Overlap
`ping coils can be planar and disposed within a flexible
`ergonomic body wrap that is not contemplated or possible
`using the devices of the prior art. The plurality of overlap
`ping coils also provides an appropriate area of intense
`electromagnetic Stimulation to bathe the nerves, muscles,
`and/or body tissues more thoroughly than any of the existing
`Single coils devices.
`The present invention proposed a separate flexible wrap
`designed for each part of the body to be treated. Each Such
`body wrap has marking indicia that enable an untrained
`patient to properly locate the Stimulation coils to effectively
`treat that specific area of body. No skilled technician need be
`used in the treatment. The devices of the prior art cannot be
`used in a flexible body wrap because of the necessity to
`utilize a Solid Single core.
`Hence, the device of the present invention permits the
`planar coils to be used in a flexible body wrap, not contem
`plated or possible by any prior art device. The Overlapping
`coils create an amplified electromagnetic field to Stimulate
`nerves, muscles, and/or other body tissues without the use of
`using a Solid core. These advancements are not taught or
`contemplated by the prior art and produce an unexpected
`increase in the electromagnetic field intensity capable of
`Stimulating nerves, muscles, and/or other body tissues. AS
`Such the overlapping coils can be placed in a flat plane (or
`in a contoured plane Surrounding a particular part of the
`body), or disposed in an ergonomic flexible body wrap also
`not contemplated by the prior art devices.
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`DETAILED DESCRIPTION OF THE
`INVENTION
`
`DRAWINGS
`These and other features, aspects and advantages of the
`present invention would become better understood with
`reference to the following description, appended claims and
`the accompanying drawings where:
`FIG. 1 is an illustration of a logic controller, which can be
`coupled to an ergonomic wrap containing the Overlapping
`planar coils,
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`FIG. 2 is a Simple ergonomic Strap containing the coils of
`the present invention;
`FIG. 3 is an ergonomic pelvic wrap containing the coils of
`the present invention;
`FIG. 4 is an ergonomic thigh wrap containing the coils of
`the present invention disposed on the thigh of a patient;
`FIG. 5 is an ergonomic lumbar/Sacral wrap containing the
`coils of the present invention disposed on the back of a
`patient;
`FIG. 6 is a Side view of an ergonomic knee wrap con
`taining the coils of the present invention disposed on the
`knee of a patient;
`FIG. 7 is a front view of an ergonomic knee wrap
`containing the coils of the present invention disposed on the
`knee of a patient; and,
`FIG. 8 is a front view of an ergonomic shoulder wrap
`containing the coils of the present invention disposed on the
`shoulder of a patient.
`FIG. 9 is a croSS-Sectional view of a typical ergonomic
`wrap of the present invention.
`DETAILED DESCRIPTION OF THE
`INVENTION
`The following is a description of an electromagnetic
`Stimulating device of the present invention that comprises or
`alternatively consists of a logic controller coupled to an
`array of coils, disposed within an ergonomic body wrap for
`use by patients for Self-treating the conditions described
`herein.
`The logic controller 20, FIG. 1, is a device through which
`current is provided to an array of Stimulation coils. The logic
`controller 20 controls the activation of the stimulation coils,
`as well as the rate of Stimulation of a given coil. The logic
`controller also allows for the adjustment of Stimulatory
`channels and/or for the amount of current provided to any
`one coil at any one time. In one embodiment, FIG. 2, a
`Simple ergonomic Strap 30 is shown having a positioning
`locking mechanism like Velcro for holding it in place. The
`strap 30 has a body 34 into which the planar flexible coils 32
`is disposed. One or more arrays of coils 32 can be electri
`cally charged by the logic controller 20 by means of a
`multiple Socketed plug. 38, which has a Socket and lead for
`each coil 32 and is coupled to each coil by means of
`electrical wiring 36. The logic controller 20 permits the
`activation or deactivation of individual coils, as well as
`adjustment of the rate of Stimulation and the amplitude of the
`stimulus. Three or more arrays of coils 32 may be controlled
`by the logic controller 32 for allowing stimulation of mul
`tiple coils in Sequence or Simultaneously.
`The logic controller 20 in the preferred embodiment is
`lightweight and easily transportable. The logic controller 20
`preferably plugs into a standard U.S. outlet (115 Volts, 10
`Amps, 60 Hz) by means of a standard plug 28, FIG. 1. In
`alternative embodiments, the logic controller 20 is designed
`to plug into a Standard European outlet, a Standard Japanese
`outlet, a Standard Canadian outlet, or a Standard Australian
`outlet. Still in other embodiments, the logic controller 20
`plugs into either an AC or a DC outlet.
`The logic controller 20 of the present invention is not
`claimed to have any circuitry that is not well known in the
`art. However, for explanation purposes the circuitry of the
`preferred embodiment is described hereinafter without ref
`erence to a Schematic or drawing.
`The internal circuitry of the logic controller 20 comprises
`or alternatively consists of a transformer, a capacitor, an
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`inducting coil, a diode, and a Switch. The logic controller 20
`can further comprise or consist of a bridge rectifier.
`A transformer (not shown) is a device that takes a first
`current and Voltage and converts it to a Second current and
`Voltage through electromagnetic induction. For example
`transformer (1:2) has an output of approximately 230 Volts
`and 5 Amps. In Some embodiments, the transformer is 1:1
`with an output of 115 volts (~170 post bridge-rectifier). In
`alternative embodiments the transformer as an output of at
`least 50 volts, at least 100 volts, at least 150 volts, at least
`200 volts, at least 250 volts, at least 300 volts, at least 400
`volts, or at least 500 volts. In other alternative embodiments
`the transformer bus an output of at least 1 Amp, at least 2.5
`Amps, at least 5 Amps, at least 10 Amps, or at least 20 Amps.
`Abridge rectifier (not shown) is for example an electrical
`component consisting of four diodes that when wired to a
`transformer will convert AC to DC. The bridge rectifier
`converts the output voltage from AC to DC. The bridge
`rectifier must be rated to at least 1 kW and 350 Volts as the
`rectified output voltage will be approximately 320 Volts. In
`alternative embodiments, the bridge rectifier is rated to at
`least 120 volts, at least 250 volts, at least 300 volts, at least
`350 volts, or at least 400 volts. In other alternative
`embodiments, the bridge rectifier is rated to at least 100 W,
`at least 500 W, at least 2,000 W, at least 5,000 W, or at least
`10,000 W.
`A capacitor and a stimulating coil (not shown) are pro
`vided in parallel. For example the capacitor is at least 40,000
`microfarads and is rated to 320 Volts, and provides approxi
`mately 2050 Joules/pulse. In alternative embodiments, the
`capacitor is at least 20,000 microfarads, at least 30,000
`microfarads, at least 35,000 microfarads, at least 45,000
`microfarads, at least 50,000 microfarads, at least 100,000
`microfarads, at least 500,000 microfarads, at least 1,000,000
`microfarads, or at least 5,000,000 microfarads. In other
`alternative embodiments the capacitor is rated to at least 120
`volts, at least 200 volts, at least 250 volts, at least 300 volts,
`at least 350 volts, at least 400 volts, or at least 450 volts.
`In yet other preferred embodiments, the capacitor is rated
`to only 200 Volts at less than 7000 microfarads. In alterna
`tive embodiments, the capacitor is rated to no more than 400
`volts, no more than 300 volts, no more than 250 volts, no
`more than 225 volts, no more than 200 volts, no more than
`175 volts, no more than 150 volts, no more than 125 volts,
`or no more than 100 volts. In other embodiments the
`capacitor is no more than 10,000 microfarads, no more than
`9,000 microfarads, no more than 8,000 microfarads, no more
`than 6,000 microfarads, no more than 5,000 microfarads, or
`no more than 4,000 microfarads.
`The inducting coil FIG. 1, is any overlapping array of
`coils 32 that is disposed within an ergonomic wrap 30 to
`cover the tissues for which the stimulation is intended. One
`or more coils or arrays of coils may be attached to the logic
`controller as described in more detail below.
`Between the capacitor (not shown) and the inducting coil
`is a diode to prevent ringing and oscillation between the
`capacitor and inductor. In one form the diode is preferably
`of the Same rating as the bridge rectifier described above.
`Distal to the inductor is a switch (not shown) that in one
`position allows the capacitor to discharge to ground through
`the Stimulating coils 32. In the other position, the Switch
`prevents the capacitor from discharging to ground and
`allows the capacitor to be charged. Each coil 32 attached to
`the logic controller 20 may have its own internal Switching
`mechanism to allow firing of the coil 32 in Sequence or to
`allow the firing of multiple coils Simultaneously. In preferred
`
`15
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`25
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`35
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`40
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`45
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`50
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`55
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`60
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`65
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`US 6,701,185 B2
`
`8
`embodiments, the Switch activates a Stimulation repetition
`rate of at least 1 Hz and a pulse duration of greater than 10
`milliseconds. In other preferred embodiments, the pulse
`duration is greater than 1 milliseconds, greater than 5
`milliseconds, greater than 25 milliseconds, greater than 50
`milliseconds, greater than 100 milliseconds greater than 125
`milliseconds, greater than 150 milliseconds, greater than 175
`milliseconds, or greater than 200 milliseconds. In other
`referred embodiments the Stimulation repetition rate is at
`least 0.5, 10, 25, 50, 100, or 500 Hz.
`In preferred embodiments, Stimulation occurs through
`firing each coil 32 individually, while using Switches to short
`out the overlapping coils 32 to prevent low-impedance
`interference. In the preferred embodiment there is one target
`coil (the center coil). The two flanking coils are charged as
`is the target coil (the center coil) in a predetermined
`sequence. The coil orientation will be such that the fields
`generated by the coils will be additive with maximum field
`generation being in the areas between the target and flanking
`coils. The choice of mode of stimulation will depend on the
`needs of the Site of Stimulation and will be programmable
`using methods and apparati well known in the art.
`In a preferred embodiment, the Step-up transformer is
`linked to the bridge rectifier, which is linked in parallel to a
`capacitor and inducting coil between which is a diode, and
`wherein the inducting coil is linked to a Switch.
`The array of coils 32, FIG. 2, may take a variety of
`configurations. In preferred embodiments, the coils overlap
`to ensure that the Subcutaneous tissue is adequately
`carpeted, see FIGS. 2 through 8. In preferred embodiments,
`the coils 32 overlay the tissue for which the stimulation is
`intended.
`In preferred embodiments, each coil will be between 5
`and 100 mm in diameter. In alternative embodiments, each
`coil will be at least 5 mm, at least 10 mm, at least 20 mm,
`at least 40 mm, at least 75 mm at least 100 mm, at least 125
`mm, at least 150 mm, or at least 200 mm in diameter. In
`preferred embodiments, each coil has a 40 mm diameter.
`In preferred embodiments each coil consists of insulated
`wire, either threaded or Single core, for example, wrapped
`multiple times to obtain a configuration of overlapping
`circles. Preferably, the coils are #12 insulated flat-wound
`copper wire wrapped 20 times. In other embodiments the
`coils are #10, #14, #16, #18, or #20 insulated flat-wound
`copper wire.
`In alternati