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`Application Number
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`First Named Inventor
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`To Be Assigned
`Herewith
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`Tomas SCHWARZ
`
`Title
`
`AESTHETIC METHOD OF BIOLOGICAL STRUCTURE TREATMENT BY
`MAGNETIC FIELD
`
`Art Unit
`
`To Be Assigned
`To Be Assigned
`Attorney Docket Number 4387.0050007
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`Examiner Name
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`SIGNATURE of Applicant or Patent Practitioner
`/Richard D. Coller Ill/
`Richard D. Coller Ill
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`Signature
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`Name
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`Date (Optional) November 4, 2019
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`Registration
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`60,390
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`BTL Medical Technologies S.R.O.
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`LUMENIS EX1003
`Page 1
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`

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`PTO/AIA/15 (10-17)
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`4387. 0050007
`First Named Inventor Tomas SCHWARZ
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`Attorney Docket No.
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`LUMENIS EX1003
`Page 2
`
`

`

`AESTHETIC METHOD OF BIOLOGICAL STRUCTURE TREATMENT
`BY MAGNETIC FIELD
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`[0001]
`
`This Application is a Continuation of U.S. Patent Application No. 16/266,494, filed
`
`February 4, 2019, now pending, which claims priority to U.S. Provisional Patent Application No.
`
`62/786, 731, filed December 31, 2018, now pending, and which is a Continuation-in-part of
`
`15/601,719, filed May 22, 2017, now pending, which claims priority to U.S. Provisional Patent
`
`Application Nos. 62/357,679 filed July 1, 2016, now expired; 62/440,905 filed December 30, 2016,
`
`now expired; and 62/440,922 filed December 30, 2016, now expired. These applications are
`
`incorporated herein by reference.
`
`FIELD OF THE INVENTION
`
`[0002]
`
`The present invention generally relates to device and methods using the influence of
`
`magnetic and induced electric field on biological structure. The magnetic field is time-varying and
`
`high powered therefore the method is based on a value of magnetic flux density sufficient to induce
`
`at least muscle contraction. The invention proposes further to combine the magnetic field with
`
`radiofrequency, light, mechanical or pressure source in order to provide an apparatus for improved
`
`treatment.
`
`BACKGROUND OF THE INVENTION
`
`[0003]
`
`Aesthetic medicine includes all treatments resulting in enhancing a visual appearance
`
`and satisfaction of the patient. Patients want to minimize all imperfections including body shape and
`
`effects of natural aging. Indeed, patients request quick, non-invasive procedures providing
`
`satisfactory results with minimal risks.
`
`[0004]
`
`The most common methods used for non-invasive aesthetic applications are based on
`
`application of mechanical waves, e.g. ultrasound or shock wave therapy; or electromagnetic waves,
`
`e.g. radiofrequency treatment or light treatment, such as intense pulsed light or laser treatment. The
`
`effect of mechanical waves on tissue is based especially on cavitation, vibration and/or heat inducing
`
`LUMENIS EX1003
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`- 2 -
`effects. The effect of applications using electromagnetic waves is based especially on heat
`
`production in the biological structure. However, the currently used treatment methods are used
`
`separately.
`
`[0005]
`
`A mechanical treatment using mechanical waves and/or pressure were used for
`
`treatment of cellulite or adipose cells. However, mechanical treatment includes several drawbacks
`
`such as risk of a panniculitis and/or non-homogenous result.
`
`[0006]
`
`A thermal treatment is applied to the patient for enhancing a visual appearance of the
`
`skin by e.g. increasing production of collagen and/or elastin, smoothing the skin or reduction of
`
`cellulite and/or adipose cell. However, thermal treatment includes several drawbacks such as risk of
`
`overheating a patient or even causing a thermal damage to the patient, risk of a panniculitis and/or
`
`non-homogenous result.
`
`[0007]
`
`The mechanical and/or the thermal treatment is not able to provide enhanced visual
`
`appearance of a muscle, e.g. muscle shaping, toning and/or volumization effect. Mechanical
`
`treatment and/or the thermal treatment includes several drawbacks such as risk of a panniculitis,
`
`non-homogenous result and others.
`
`[0008]
`
`Current magnetic methods are limited in key parameters which do not allow
`
`satisfactory enhancement of visual appearance. As a result, new methods are needed to enhance the
`
`visual appearance of the patient.
`
`[0009]
`
`Existing devices have low efficiency and they waste energy, which limits their use.
`
`Eddy currents induced within the magnetic field generating device create engineering challenges.
`
`Existing devices contain magnetic field generating devices which are made of metallic strips, electric
`
`wires or hollow conductors. Since the therapy requires large currents, significant losses are caused
`
`by induced eddy currents within the magnetic field generating device. Eddy currents lead to
`
`production of unwanted heat and therefore there is need to sufficiently cool the magnetic field
`
`generating device. Also, the energy source must be protected during reverse polarity of resonance.
`
`This requires using protective circuits which consume significant amounts of energy. Skin tissue is
`
`composed of three basic elements: epidermis, dermis and hypodermis or so called subcutis. The
`
`outer and also the thinnest layer of skin is the epidermis. The dermis consists of collagen, elastic
`
`tissue and reticular fibers. The hypodermis is the lowest layer of the skin and contains hair follicle
`
`roots, lymphatic vessels, collagen tissue, nerves and also fat forming a subcutaneous white adipose
`
`Attorney Docket No. 4387.0050007
`
`LUMENIS EX1003
`Page 4
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`- 3 -
`tissue (SW AT). The adipose cells create lobules which are bounded by connective tissue, fibrous
`
`septa (retinaculum cutis).
`
`[0010]
`
`Another part of adipose tissue, so called visceral fat, is located in the peritoneal cavity
`
`and forms visceral white adipose tissue (VW AT) located between parietal peritoneum and visceral
`
`peritoneum, closely below muscle fibers adjoining the hypodermis layer.
`
`[0011]
`
`The currently used aesthetic applications don't provide any treatment combining the
`
`effect of time-varying magnetic field treatment and an auxiliary treatment method, e.g. treatment by
`
`thermal treatment and/or mechanical treatment. The currently used thermal treatment includes many
`
`adverse events such as non-homogenous temperature distribution, panniculitis, insufficient blood
`
`and/or lymph flow during and/or after the treatment. Additionally, several adverse event such as
`
`panniculitis may occur after the treatment. Further the treatment may be painful so that a topical
`
`anesthetic is recommended.
`
`[0012]
`
`The development of new aesthetic treatment methods providing improved results in
`
`shorter time periods is needed.
`
`SUMMARY OF THE INVENTION
`
`[0013]
`
`The treatment methods and devices as described below produce a time varying
`
`magnetic field for patient treatment which better optimizes energy use, increases the effectiveness of
`
`the treatments and provide a new treatment. The magnetic impulses may be generated in
`
`monophasic, biphasic or polyphasic regimes. In a first aspect, the device has one or more magnetic
`
`field generating devices; a switch; an energy storage device and a connection to an energy source.
`
`The magnetic field generating device may be made of wires with a cross-section surface less than
`100 cm2
`
`. The magnetic field generating device may be flexibly attached in a casing of device. The
`
`casing may comprise a blower or blowers which ensure cooling of the magnetic field generating
`
`device.
`
`[0014]
`
`The present methods provide new aesthetic applications for focused remodeling of the
`
`patient's body. The magnetic field generating device of the magnetic treatment device may be
`
`flexibly attached to casing of the device. The blower or blowers may be arranged to blow air on both
`
`sides of magnetic field generating device. Optionally, the magnetic field generating device may be a
`
`flat type magnetic field generating device.
`
`Attorney Docket No. 4387.0050007
`
`LUMENIS EX1003
`Page 5
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`

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`[0015]
`
`- 4 -
`The new magnetic treatment methods may improve a muscle of the patient. Further
`
`the new magnetic treatment method enables improved treatment results. Alternatively, the magnetic
`
`treatment may provide pain relief and/or myorelaxation effect to the patient.
`
`[0016]
`
`The method of treating a biological structure uses a combination of non-invasive
`
`methods for enhancing human appearance. The invention utilizes electromagnetic field. Methods
`
`may be used for targeted remodeling of adipose tissue, focused treatment of cellulite, body
`
`contouring, skin tightening or skin rejuvenation. The invention relates to focused heating of the
`
`target tissue by electromagnetic waves, whereas the effect of focused heating of the target tissue is
`
`amplified by the effect of a magnetic treatment.
`
`[0017]
`
`The time-varying magnetic field induces the muscle contraction at higher repetition
`
`rates and the contraction is stronger. The treatment may be more efficient for reducing the number
`
`and/or volume of adipocytes and enhancing the visual appearance of the treated body region via
`
`targeted muscle contraction. Further the temperature homogeneity of is improved. Additionally,
`
`strong muscle contractions at higher repetition rates cause mechanical movement of all the layers in
`
`proximity of the contracted muscle. The methods therefore cause remodeling and/or neogenesis of
`
`the collagen and elastin fibers.
`
`[0018]
`
`The methods enable new treatments by magnetic and/or electromagnetic field. The
`
`repetition rate of the magnetic field is in the range of I to 300 Hz with high magnetic flux density up
`
`to 7 Tesla (equivalent to 70000 Gauss). The frequency of the electromagnetic field is 13.56 or 40.68
`
`or 27.12 MHz or 2.45 GHz.
`
`[0019]
`
`On the other hand, a combination with a magnetic treatment method may enhance the
`
`visual appearance of the muscle and/or other soft tissue such as skin or adipose tissue, including
`
`increase of apoptotic index.
`
`[0020]
`
`The methods enable combined treatment using different treatment methods such as
`
`magnetic and/or auxiliary treatment methods. The combination of different treatment methods
`
`provide a complex treatment method for focused treatment of a treated body region.
`
`[0021]
`
`The present methods provide combined treatment using influence of magnetic
`
`treatment and mechanical treatment by shock waves, ultrasound waves, acoustic waves and/or
`
`pressure application. The mechanical treatment may induce mechanical damage to the treated
`
`biological structure and/or tissues. Ultrasound waves may heat adipose cells, dermis, hypodermis or
`
`other target biological structure. Ultrasound waves may also induce a cavitation.
`
`Attorney Docket No. 4387.0050007
`
`LUMENIS EX1003
`Page 6
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`

`

`[0022]
`
`- 5 -
`The present methods and devices may include a handheld applicator, for manual and
`
`precise treatment of tissue, particularly of uneven areas, and scanning unit providing automated or
`
`manual positioning of the optical spot created by the optical waves (for example light) on the tissue
`
`of a subject for homogenous treatment of large areas of tissue. In some embodiments, the handheld
`
`applicator may be connected to the scanning unit by an attaching mechanism which in tum provides
`
`the handheld applicator with optical treatment. The handheld applicator may apply optical waves
`
`onto the tissue of the subject to be scanned during treatment.
`
`[0023]
`
`Present method and devices may also include sensors configured to measure various
`
`parameters of the scanning unit and the subject tissue. Based on the information from the at least one
`
`sensor a controller connected to scanning unit may change parameters of the optical treatment
`
`system and method, including but not limited to the optical output, the duration of treatment, the
`
`optical spot size or shape, the scanning speed or direction of movement of the optical spot, the
`
`wavelength or wavelengths of the optical waves, the frequency, or optical flux density. Such a
`
`change may provide more homogenous treatment or may protect the patient from discomfort or
`
`harm.
`
`[0024]
`
`The present method provides combined treatment using magnetic treatment and
`
`thermal treatment. A combination of heating/cooling may cause an increase in apoptotic index,
`
`increase in muscle thickness, apoptosis and/or necrosis of the target biological structure such as
`
`adipose cells. Remodeling of the target biological structure is more significant and treatment
`
`duration is reduced. Potential risks for the patient associated with single treatment methods are
`
`avoided. Further the side effects such as swelling and/or inflammation are reduced and/or
`
`eliminated.
`
`[0025]
`
`Although methods of the present invention may be described herein as a sequence of
`
`steps in a particular order, it is understood that, unless explicitly stated otherwise, the steps of any
`
`methods of the present invention may alternatively be performed in a different order. In some
`
`embodiments, some or all of the steps of a method of the present invention may be repeated.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0026]
`
`[0027]
`
`[0028]
`
`Figure I is a cross section view of a magnetic field generating device winding.
`
`Figure 2 is a cross-section of a magnetic applicator.
`
`Figure 3a-e illustrate exemplary embodiment of an applicator.
`
`Attorney Docket No. 4387.0050007
`
`LUMENIS EX1003
`Page 7
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`

`

`[0029]
`
`[0030]
`
`- 6 -
`Figure 4a-4c illustrates a positioning arm.
`
`Figures Sa and Sb illustrate circuits for providing high power pulses to a stimulating
`
`magnetic field generating device.
`
`[0031]
`
`[0032]
`
`[0033]
`
`[0034]
`
`[0035]
`
`Figure 6 illustrates dimensions of a magnetic field generating device.
`
`Figure 7 is a graph showing voltage drop in the energy storage device.
`
`Figure 8 illustrates an exemplary treatment duty cycle
`
`Figure 9 is a diagram of a biological effect.
`
`Figures 1 Oa and 1 Ob illustrate diagrams of a treatment device and/or an applicator
`
`providing magnetic and/or mechanical treatment.
`
`[0036]
`
`Figures Ila and llb illustrate diagrams of a treatment device and/or an applicator
`
`providing magnetic and/or thermal treatment.
`
`[0037]
`
`Figure 12 illustrates an exemplary embodiment of a treatment device including two
`
`circuits generating independent magnetic fields.
`
`[0038]
`
`[0039]
`
`[0040]
`
`[0041]
`
`[0042]
`
`[0043]
`
`Figure 13 illustrates an exemplary trapezoidal envelope.
`
`Figure 14 illustrates types of muscle contraction.
`
`Figures 15 illustrate exemplary applications for buttock treatment.
`
`Figure 16 illustrates an exemplary application for abdomen treatment.
`
`Figure 17 illustrates a combined treatment administered by two separate devices.
`
`Figures 18a and 18b illustrate a combined treatment administered by one device
`
`including a plurality of applicators comprising magnetic field generating device or optical waves
`
`generating device.
`
`[0044]
`
`Figures 19a and 19b illustrate a combined treatment by one device including one
`
`applicator comprising at least one magnetic field generating device and at least one optical waves
`
`generating device.
`
`[0045]
`
`Figures 20a and 20b illustrate a combined treatment with optical waves generating
`
`device powered by magnetic field generated by magnetic field generating device.
`
`[0046]
`
`[0047]
`
`[0048]
`
`[0049]
`
`[0050]
`
`Figure 21 illustrates a diagram of an exemplary device.
`
`Figures 22a and 22b illustrate exemplary handheld applicators.
`
`Figure 23a illustrates a handheld applicator disconnected from a scanning unit.
`
`Figure 23b illustrates a handheld applicator connected to a scanning unit.
`
`Figure 24 illustrates examples of treatment patterns.
`
`Attorney Docket No. 4387.0050007
`
`LUMENIS EX1003
`Page 8
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`

`

`[0051]
`
`[0052]
`
`[0053]
`
`- 7 -
`Figures 25a and 25b illustrate examples of a treatment area and treatment pattern.
`
`Figures 26a-26c illustrate examples of energy distribution.
`
`Figure 27 illustrates an example of device using negative pressure.
`
`DETAILED DESCRIPTION
`
`[0054]
`
`It is to be understood that the figures and descriptions of the present invention have
`
`been simplified to illustrate elements that are relevant for a clear understanding of the present
`
`invention, while eliminating, for the purpose of clarity, many other elements found in related
`
`systems and methods. Those of ordinary skill in the art may recognize that other elements and/or
`
`steps are desirable and/or required in implementing the present invention. However, because such
`
`elements and steps are well known in the art, and because they do not facilitate a better
`
`understanding of the present invention, a discussion of such elements and steps is not provided
`
`herein. The disclosure herein is directed to all such variations and modifications to such elements
`
`and methods known to those skilled in the art.
`
`[0055]
`
`As used herein, "auxiliary treatment" may refer to an additional treatment other than
`
`treatment via time-varying magnetic field. Examples of auxiliary treatments may include, but are
`
`not limited to, application of mechanical waves, e.g. acoustic wave, ultrasound or shock wave
`
`therapy; or electromagnetic waves, e.g. radiofrequency or diathermy treatment or light treatment,
`
`such as intense pulsed light or laser treatment; or mechanical treatment, e.g. positive or negative
`
`pressure, rollerball, massage etc.; or thermal treatment, e.g. cryotherapy; or electrotherapy method;
`
`or mesotherapy methods and/or any combination thereof. Auxiliary treatments may be invasive or
`
`non-invasive, or may include a combination of invasive and non-invasive treatment steps.
`
`[0056]
`
`Individual embodiments of an auxiliary treatment may be used interchangeably herein
`
`in exemplary embodiments. Unless explicitly stated otherwise, any exemplary embodiment
`
`referring to one auxiliary treatment should be treated as a disclosure of an exemplary embodiment
`
`referring to any of the listed auxiliary treatments.
`
`[0057]
`
`Thermal treatment may refer to treatment by heating or cooling, e.g. a cryotherapy
`
`treatment.
`
`[0058]
`
`Mechanical treatment may refer to treatment methods using applying a pressure such
`
`as positive or negative; applying mechanical waves such as shock waves, ultrasound waves or
`
`vibration.
`
`Attorney Docket No. 4387.0050007
`
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`Page 9
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`

`[0059]
`
`- 8 -
`Biological structure may be at least one neuron, neuromuscular plate, muscle fiber,
`
`adipose cell or tissue, collagen, elastin, pigment or skin.
`
`[0060]
`
`Remodeling target biological structure may refer to reducing the number and/or
`
`volume of the adipocytes by apoptosis and/or necrosis, cellulite treatment, body shaping and/or
`
`contouring, muscle toning, skin tightening, collagen treatment, skin rejuvenation, wrinkle removing,
`
`reducing stretchmarks, breast lifting, buttock lifting, buttock rounding, buttock firming, lip
`
`enhancement, treatment of vascular or pigmented lesions of the skin or hair removing.
`
`[0061]
`
`Body region may include a muscle or a muscle group, buttock, saddlebag, love
`
`handle, abdomen, hip, leg, calf, thigh, arm, limb, face or chin and/or any other tissue.
`
`[0062]
`
`Muscle may include at least one of muscle fiber, muscle tissue or group,
`
`neuromuscular plate or nerve innervating the at least one muscle fiber.
`
`[0063]
`
`Deep muscle may refer to a muscle that is at least partly below superficial muscles
`
`and/or to the muscle covered by the thick layer of other tissue, e.g. mostly adipose tissue and/or the
`
`skin, with thickness 0.5, 1, 2, 3, 4, 5 or more centimeters.
`
`[0064]
`
`[0065]
`
`Adipose tissue may refer to at least one lipid rich cell, e.g. adipocyte.
`
`Bolus may refer to a layer of fluid material, e.g. water or fluid solution of ceramic
`
`particles, preferably enclosed in a flexible sac made of biocompatible material.
`
`[0066]
`
`Impulse may refer to a magnetic stimulus, i.e. generating/applying of magnetic field
`
`causing at least one muscle contraction. The impulse may be but not limited to monophasic,
`
`polyphasic, biphasic magnetic field.
`
`[0067]
`
`Pulse may refer to a period of treatment consisted of one impulse and time duration of
`
`a) no magnetic field applied to the patient orb) application magnetic field insufficient to cause a
`
`muscle contraction.
`
`[0068]
`
`Repetition rate may refer to frequency of firing the pulses; it is derived from the time
`
`duration of a pulse. It equals to a frequency of switching the switch on.
`
`[0069]
`
`The train may refer to a plurality of pulses, i.e. at least two pulses followed one by
`
`another. Train may cause multiple muscle contractions followed one by one, at least one incomplete
`
`tetanus muscle contraction or at least one complete tetanus muscle contraction.
`
`[0070]
`
`Burst may refer to one train and a time with no magnetic field generated, or the train
`
`followed by a static magnetic field, or the train followed by a time-varying magnetic field
`
`Attorney Docket No. 4387.0050007
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`LUMENIS EX1003
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`insufficient to cause a muscle contraction; it refers to at least one muscle contraction followed by no
`
`muscle contraction and/or muscle relaxation.
`
`[0071]
`
`Combined treatment may refer to a combination of at least two different treatment
`
`methods, e.g. application of magnetic field and one or more auxiliary treatments, application of
`
`magnetic field and thermal treatment, application of magnetic field and mechanical treatment, or
`
`application of magnetic field with thermal treatment and mechanical treatment.
`
`[0072]
`
`Hardware panel may refer to at least one hardware component used for controlling the
`
`optical and/or magnetic treatment. The hardware panel includes at least one of input interface for
`
`inputting treatment parameters by an operator and processing unit for controlling the optical and/or
`
`magnetic treatment.
`
`[0073]
`
`Optical waves may refer to UV radiation, visible light, IR radiation, far IR radiation.
`
`Further optical waves may be coherent and/or non-coherent, monochromatic or polychromatic.
`
`[0074]
`
`Optical waves generating device may refer to laser or laser diode, light emitting diode
`
`(LED), electric discharge source, incandescent source, fluorescent source, luminescent source,
`
`electroluminescent source etc.
`
`[0075]
`
`Optical treatment parameter may refer but not limited to the optical output, treatment
`
`duration, optical spot size and shape, scanning speed, direction of the movement of the optical spot,
`
`treatment pattern, a wavelength or wavelengths of the optical radiation, the frequency energy flux or
`
`the distance between the subject tissue and the scanning unit or handheld applicator.
`
`[0076]
`
`The magnetic treatment device may include at least one magnetic field generating
`
`device. Alternatively, the magnetic treatment device may include a plurality of the magnetic field
`
`generating devices. The at least one applicator may include at least one magnetic field generating
`
`device. Alternatively, at least one applicator may include the plurality of the magnetic field
`
`generating devices.
`
`[0077]
`
`Throughout this disclosure, various aspects of the invention can be presented in a
`
`range format. It should be understood that the description in range format is merely for convenience
`
`and brevity and should not be construed as an inflexible limitation on the scope of the invention.
`
`Accordingly, the description of a range should be considered to have specifically disclosed all the
`
`possible subranges as well as individual numerical values within that range. For example,
`
`description of a range such as from I to 6 should be considered to have specifically disclosed
`
`subranges such as from I to 3, from I to 4, from I to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as
`
`Attorney Docket No. 4387.0050007
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`well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, 6 and any whole and
`
`partial increments therebetween. This applies regardless of the breadth of the range.
`
`[0078]
`
`Figure 1 illustrates an exemplary embodiment of a cross section of winding of a
`
`magnetic field generating device for a magnetic treatment device. The magnetic field generating
`
`device may be constructed from litz-wire, wherein each wire is insulated separately. Each individual
`
`conductor is coated with non-conductive material so the magnetic field generating device constitutes
`
`multiple insulated wires. Alternatively, the magnetic field generating device may be made of bare
`
`wire e.g. litz-wire without insulation, or conductive tapes, conductive strips, or copper pipe with
`
`hollow inductors. The insulation of wires separately may be a substantial improvement, since it may
`
`lead to a significant reduction of the induced eddy currents. Power loss due to eddy currents, per
`
`single wire, is described by Equation 1 below. The small diameter of wires may reduce self-heating
`
`of the magnetic field generating device and therefore increase efficiency of the present magnetic
`
`treatment device.
`
`1r2 ,B2 ,d2. f2
`p = - - -P __ _
`D
`6 k
`. ·p·
`EDDY
`
`,
`
`Eq. 1
`
`[0079]
`
`where: PEDDY is power loss per unit mass (W·kg-1
`
`); BP is the peak of magnetic field
`
`(T);f is frequency (Hz); dis the thickness of the sheet or diameter of the wire (m); k is constant
`
`equal to 1 for a thin sheet and 2 for a thin wire; pis the resistivity of material (Q·m); Dis the density
`of material (kg·m3
`).
`
`[0080]
`
`The individual insulation of each wire may reduce eddy currents. The individually
`
`insulated wires may be wound either one by one or in a bundle of individually insulated wires so as
`
`to form a magnetic field generating device, which may serve as a magnetic field generator. The
`
`magnetic field generating device may provide an improvement in the efficiency of energy transfer in
`
`the LC resonant circuit and also reduces or eliminates unwanted thermal effects.
`
`[0081]
`
`The magnetic field generating