I 1111111111111111 1111111111 lllll lllll 111111111111111 11111 111111111111111111
`
`US010124187B2
`
`c12) United States Patent
`Schwarz et al.
`
`(IO) Patent No.: US 10,124,187 B2
`(45) Date of Patent:
`Nov. 13, 2018
`
`(54) COMBINATION OF RADIOFREQUENCY
`AND MAGNETIC TREATMENT METHODS
`
`(71) Applicant: BTL HOLDINGS LIMITED, Nicosia
`(CY)
`
`(72)
`
`Inventors: Tomas Schwarz, Prague (CZ); Ondra
`Prouza, Ricany u Prahy (CZ)
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3,915,151 A * 10/1975 Kraus
`
`A61B 17/58
`600/13
`4,237,898 A * 12/1980 Whalley .................. A61N 1/40
`607/99
`
`(Continued)
`
`(73) Assignee: BTL Holdings Limited, Nicosia (CY)
`
`FOREIGN PATENT DOCUMENTS
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by O days.
`
`EP
`EP
`
`1/1987
`0209246 Al
`12/2013
`2676700 A2
`(Continued)
`
`OTHER PUBLICATIONS
`
`(21) Appl. No.: 15/151,012
`
`(22) Filed:
`
`May 10, 2016
`
`(65)
`
`Prior Publication Data
`
`US 2016/0317827 Al
`
`Nov. 3, 2016
`
`Related U.S. Application Data
`
`(63) Continuation-in-part of application No. 15/073,318,
`filed on Mar. 17, 2016, now Pat. No. 9,919,161,
`(Continued)
`
`(51)
`
`Int. Cl.
`A61N 2102
`A61N 2100
`
`(2006.01)
`(2006.01)
`(Continued)
`
`(52) U.S. Cl.
`CPC ............. A61N 21002 (2013.01); A61N 11403
`(2013.01); A61B 18/1815 (2013.01);
`(Continued)
`( 58) Field of Classification Search
`CPC .................................. A61N 2/02; A61N 2/002
`(Continued)
`
`Lin, et al., "Functional Magnetic Stimulation: A New Modality for
`Enhancing Systemic Fibrinolysis," Arch Phys Med Rehabil vol. 80,
`May 1999, pp. 545-550.
`
`(Continued)
`Primary Examiner - Samuel Gilbert
`(74) Attorney, Agent, or Firm - Kenneth H. Ohriner;
`Perkins Coie LLP
`ABSTRACT
`(57)
`Devices and methods for contactless skin treatment use
`feedback power control for non-invasive treatment of skin
`and human tissue. Electromagnetic energy heats skin or
`tissue. A feedback system measures an output physical
`quantity before the output of electromagnetic waves from
`the device into the patient. Alternatively the feedback sys(cid:173)
`tem scans values of a physical quantity on or near the
`patient. The devices and methods allow for delivering the
`optimum amount of energy to the patient while reducing the
`thermal load of the device. Methods and an apparatus for
`treatment of target biological structure by combination of
`magnet treatment and electromagnetic
`treatment. The
`method and apparatus may be used for aesthetic applica(cid:173)
`tions, e.g. cellulite treatment, body shaping, skin rejuvena(cid:173)
`tion or enhancing skin appearance.
`30 Claims, 9 Drawing Sheets
`
`Power
`Source
`............. (cid:141)
`
`!
`
`_ _D 0
`Power
`Supply
`
`Ll
`
`411 -..
`
`ce/;i8tor }---,<>
`
`t
`": 14~ ..
`\ .. ~ - - - - -~ - -~
`,-'--'-----
`Transrnatch and (Jenerator
`Controi Un/
`+
`y,)--···,
`t
`..
`\
`· \11icmprocessor Contml Unit
`· _ -------------~~~~-!~---~~~-~:~-~ !nterface
`
`LUMENIS EX1001
`Page 1
`
`

`

`US 10,124,187 B2
`Page 2
`
`(51)
`
`(52)
`
`(58)
`
`(56)
`
`Related U.S. Application Data
`
`which is a continuation-in-part of application No.
`14/951,093, filed on Nov. 24, 2015, now abandoned,
`which is a continuation-in-part of application No.
`14/926,365, filed on Oct. 29, 2015, now abandoned,
`which is a continuation-in-part of application No.
`14/789,658, filed on Jul. 1, 2015, now Pat. No.
`9,636,519, which is a continuation-in-part of appli(cid:173)
`cation No. 14/873,110, filed on Oct. 1, 2015, now Pat.
`No. 9,586,057, which is a continuation of application
`No. 14/789,156, filed on Jul. 1, 2015, application No.
`15/151,012, which is a continuation-in-part of appli(cid:173)
`cation No. 15/099,274, filed on Apr. 14, 2016, now
`abandoned, which is a continuation-in-part of appli(cid:173)
`cation No. 14/697,934, filed on Apr. 28, 2015, now
`Pat. No. 9,468,774, which is a continuation-in-part of
`application No. 14/700,349, filed on Apr. 30, 2015,
`now Pat. No. 9,446,258.
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A61N 1140
`A61N 5/02
`A61B 18/18
`A61B 18/00
`A61B 18/14
`A61B 18/20
`A61N 2/06
`U.S. Cl.
`CPC ..... A61B 18/20 (2013.01); A61B 2018/00464
`(2013.01); A61B 2018/00476 (2013.01); A61B
`2018/147 (2013.01); A61N 2/006 (2013.01);
`A61N 2/02 (2013.01); A61N 2/06 (2013.01);
`A61N 5/025 (2013.01)
`Field of Classification Search
`USPC ........................................................ 600/9-15
`See application file for complete search history.
`
`References Cited
`
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`
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`4,665,898 A
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`
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`
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`
`A61N 5/0616
`600/9
`
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`
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`
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`601/2
`
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`12/2015 Goetz
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`9/2016 Sakaki et al.
`
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`
`WO
`WO
`WO
`WO
`WO
`WO
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`
`2002025675 Al
`2003090863 Al
`2004087255 Al
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`2010135425 Al
`2015012672 Al
`
`3/2002
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`9/2008
`1/2010
`11/2010
`1/2015
`
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`
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`dated Dec. 12, 2016; 19 pages.
`Polk, "Therapeutic Applications of Low-Frequency Sinusoidal and
`Pulsed Electric and Magnetic Fields," The Biomedical Engineering
`Handbook, vol. 1, 2000, Second edition, pp. 1625-1636.
`
`* cited by examiner
`
`LUMENIS EX1001
`Page 2
`
`

`

`U.S. Patent
`
`Nov. 13, 2018
`
`Sheet 1 of 9
`
`US 10,124,187 B2
`
`"1-4
`
`/
`
`flG, 3
`
`LUMENIS EX1001
`Page 3
`
`

`

`U.S. Patent
`
`Nov. 13, 2018
`
`Sheet 2 of 9
`
`US 10,124,187 B2
`
`fl(t 4A
`
`+
`
`/
`L §/31
`=~
`-····
`C •1n. I,.
`] ..
`~ Ii
`~ - -1 r~
`
`FIG. 48
`
`LUMENIS EX1001
`Page 4
`
`

`

`U.S. Patent
`
`Nov. 13, 2018
`
`Sheet 3 of 9
`
`US 10,124,187 B2
`
`.
`
`I
`
`I 1-J
`
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`
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`~.,.,. .. _. ......... , ............... -.. -~ .............. ;:·~--;:,;·-:.~'-
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`·~=---··•,·", __ ___,.....--'
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`
`-(cid:173)
`
`---------------·+------
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`lO
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`l{)
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`c::.:
`
`0
`0
`,....
`3.0
`'
`
`LUMENIS EX1001
`Page 5
`
`

`

`U.S. Patent
`
`Nov. 13, 2018
`
`Sheet 4 of 9
`
`US 10,124,187 B2
`
`(~
`lO
`
`"(····
`"t"""··
`
`LUMENIS EX1001
`Page 6
`
`

`

`U.S. Patent
`
`Nov. 13, 2018
`
`Sheet 5 of 9
`
`US 10,124,187 B2
`
`LUMENIS EX1001
`Page 7
`
`

`

`U.S. Patent
`
`Nov. 13, 2018
`
`Sheet 6 of 9
`
`US 10,124,187 B2
`
`LUMENIS EX1001
`Page 8
`
`

`

`U.S. Patent
`
`Nov. 13, 2018
`
`Sheet 7 of 9
`
`US 10,124,187 B2
`
`flG. 13
`
`LUMENIS EX1001
`Page 9
`
`

`

`U.S. Patent
`
`Nov. 13, 2018
`
`Sheet 8 of 9
`
`US 10,124,187 B2
`
`...........
`
`·102
`·io·1
`.......... ,.,,"l ................... 1/l~!
`
`11 (cid:143)(cid:143)-
`
`u
`c·.-.-.-.-.-.-J 1 ......... 1
`
`(cid:143)(cid:143)(cid:143)
`u (cid:143)(cid:143)(cid:143)(cid:143)(cid:143)
`[:.-.-.-.-.-... J [.-.-.-.-.-.·.-.-J
`l_J [J c·.·.-.·.·.·.]
`(cid:143) (cid:143) (cid:143) (cid:143) (cid:143)
`l ........... l [.-.-.-.~~·]
`
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`
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`
`(cid:143)
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`
`r······· .. ···1
`
`FiG. 15
`
`LUMENIS EX1001
`Page 10
`
`

`

`U.S. Patent
`
`Nov. 13, 2018
`
`Sheet 9 of 9
`
`US 10,124,187 B2
`
`(
`!'-.
`'S"(cid:173)-.-- ..,__-__,
`~~ --~✓~------,../_-_-...,· '"-'--...
`
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`LUMENIS EX1001
`Page 11
`
`

`

`US 10,124,187 B2
`
`1
`COMBINATION OF RADIOFREQUENCY
`AND MAGNETIC TREATMENT METHODS
`
`PRIORITY CLAIM
`
`2
`appearance. The invention utilizes electromagnetic radia(cid:173)
`tion. Methods may be used for targeted remodeling 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 pulsed magnetic field
`treatment.
`
`Glossary
`
`5
`
`10
`
`This application is a Continuation-in-Part of each of the
`following: U.S. patent application Ser. No. 15/073,318 filed
`Mar. 17, 2016 and; Ser. No. 14/951,093 filed Nov. 24, 2015
`and now pending; Ser. No. 14/926,365 filed Oct. 29, 2015
`and now pending; and Ser. No. 14/789,658 filed Jul. 1, 2015
`and now pending. This application is also a Continuation(cid:173)
`in-Part of U.S. patent application Ser. No. 14/873,110 filed
`Oct. 1, 2015 and now pending, which is a Continuation of
`U.S. patent application Ser. No. 14/789,156 filed Jul. 1, 2015
`and now abandoned. This application is also a Continuation(cid:173)
`in-Part of U.S. patent application Ser. No. 15/099,274 filed 15
`Apr. 14, 2016 and now pending.
`This application is also a Continuation-in-Part of U.S.
`patent application Ser. No. 14/697,934 filed Apr. 28, 2015
`and now pending; and of Ser. No. 14/700,349 filed Apr. 30,
`2015 and now pending.
`Each of these applications is incorporated herein by
`reference.
`
`FIELD OF THE INVENTION
`
`The present invention generally relates to aesthetic meth(cid:173)
`ods for enhancing the visual appearance of a patient by
`stimulation using time-varying and high-power magnetic
`field based on a high value of magnetic flux density and/or
`high repetition rate.
`
`BACKGROUND OF THE INVENTION
`
`Biological structure is at least one neuron, neuromuscular
`plate, muscle fiber, adipocyte, collagen, elastin, pigment or
`skin.
`Remodeling target biological structure refers 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 treat(cid:173)
`ment, skin rejuvenation, wrinkle removing, reducing stretch-
`20 marks, breast lifting, lip enhancement, treatment of vascular
`or pigmented lesions of the skin or hair removing.
`Adipose tissue refers to at least one lipid rich cell, e.g.
`adipocyte.
`Bolus refers to a layer of fluid material, e.g. water or fluid
`25 solution of ceramic particles, preferably enclosed in a flex(cid:173)
`ible sac made of biocompatible material.
`Impulse refers to a single magnetic stimulus.
`Pulse refers to a period of stimulation by a magnetic field
`of at least one magnetic stimulus and time duration of no
`30 stimulation, i.e. time duration between two impulses from
`rise/fall edge to next rise/fall edge.
`As used here "continual therapy" and "continual magnetic
`stimulation" means therapy where the set of the magnetic
`flux density and frequency/repetition rate of magnetic pulses
`35 does not lead to exceeding of the operating temperature 43°
`C. on the casing of the device operating in an ambient
`temperature of 30° C. regardless of the duration of therapy.
`
`Aesthetic medicine includes all treatments resulting in
`enhancing a visual appearance and satisfaction of the
`patient. Patients want to minimize all imperfections includ(cid:173)
`ing body shape and effects of natural aging. Indeed, patients
`request quick, non-invasive procedures providing satisfac(cid:173)
`tory results with minimal risks.
`The most common methods used for non-invasive aes(cid:173)
`thetic applications are based on application of mechanical 40
`waves, e.g. ultrasound or shock wave therapy; or electro(cid:173)
`magnetic waves, e.g. radiofrequency treatment or light treat(cid:173)
`ment, 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 effects. The effect 45
`of applications using electromagnetic waves is based espe(cid:173)
`cially on heat production in the biological structure.
`Skin tissue is composed of three basic elements: epider(cid:173)
`mis, dermis and hypodermis or so called subcutis. The outer
`and also the thinnest layer of skin is the epidermis. The 50
`dermis consists of collagen, elastic tissue and reticular
`fibres. 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 tissue (SWAT). The fat cells create lobules which 55
`are bounded by connective tissue, fibrous septa (retinaculum
`cutis ).
`Another part of adipose tissue, so called visceral fat, is
`located in the peritoneal cavity and forms visceral white
`adipose tissue (VWAT) located between parietal peritoneum 60
`and visceral peritoneum, closely below muscle fibres adjoin(cid:173)
`ing the hypodermis layer.
`
`BRIEF DESCRIPTION OF DRAWINGS
`
`FIG. 1 is a cross section view of a coil winding.
`FIG. 2 is an illustrative embodiment of cross-section of
`the magnetic applicator.
`FIG. 3 is an illustrative embodiment of a casing of the
`magnetic applicator.
`FIGS. 4A and 4B illustrates circuits for providing high
`power pulses to a stimulating coil.
`FIG. 5 is a graph showing voltage drop in the energy
`storage device.
`FIG. 6 is a schematic diagram of a system for controlled
`deep heating of sub dermal tissues.
`FIG. 7 is a schematic view of a trans-regional course of
`electromagnetic field.
`FIGS. 8 and 9 are schematic examples of positioning of
`electrodes shown in FIG. 1.
`FIG. 10 is schematic diagram of an alternative electrode
`design.
`FIG. 11 is schematic diagram of induced currents inside
`tissue.
`FIG. 12 is schematic diagram of induced currents inside
`tissue without use of an external magnetic field.
`FIG. 13 is schematic diagram of induced currents inside
`tissue with use of external magnetic field.
`FIG. 14 is schematic diagram of a flexible electrode
`65 arrangement in transverse cross-section.
`FIG. 15 is schematic diagram of arrangement of elec-
`trodes into a matrix.
`
`SUMMARY OF THE INVENTION
`
`A method of treating a biological structure uses a com(cid:173)
`bination of non-invasive methods for enhancing human
`
`LUMENIS EX1001
`Page 12
`
`

`

`US 10,124,187 B2
`
`3
`FIG. 16 is a block diagram of an apparatus for contactless
`skin and human tissue treatment with feedback control.
`
`DETAILED DESCRIPTION
`
`4
`FIG. 1 illustrates a cross section of winding of a coil for
`a magnetic stimulation device. The coil may be constructed
`from litz-wire, wherein each wire is insulated separately.
`Each individual conductor is coated with non-conductive
`5 material so the coil constitutes multiple insulated wires.
`Unlike existing magnetic coil conductors, the present coil is
`not 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 is a
`10 substantial improvement, since this leads 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 wires of the present coil signifi(cid:173)
`cantly reduce self-heating of the coil and therefore increases
`15 efficiency of the present magnetic stimulation device:
`
`During last few decades patient have not only wanted to
`be in good health, they have also wanted to look-well, i.e. to
`be well-shaped, without any unattractive fat and to have a
`young appearance, without wrinkles, stretchmarks or sag(cid:173)
`ging breasts. This has resulted in a progressive evolution of
`invasive aesthetic methods such as aesthetic surgery remov(cid:173)
`ing and remodeling the human body by invasive and poten(cid:173)
`tially dangerous methods, e.g. liposuction or implants. The
`side effect of invasive methods may be scars. The side
`effects resulted in the rapid progress in non-invasive method,
`e.g. lipolysis or removing skin imperfections.
`The present method may be used for remodeling the
`adipose tissue, body shaping and/or contouring, muscle
`toning, skin tightening, skin rejuvenation, wrinkle remov- 20
`ing, reducing stretchmarks, breast lifting, lip enhancement
`or treatment of cellulite in general by application of elec(cid:173)
`tromagnetic radiation to target structure to selectively heat
`the target tissue to remove and/or remodel adipose tissue
`from the target tissue. The second approach is to transmit a 25
`magnetic stimulation to the target structure, inducing at least
`partial muscle contraction within the target structure to
`remodel the adipose tissue by natural adipose tissue catabo(cid:173)
`lism. Adipose tissue catabolism may be caused by apoptosis
`or necrosis of the adipocytes. The muscle contraction caused 30
`by induced eddy current is the same as a natural contraction.
`The adipose tissue may be reduced in natural way. Addi(cid:173)
`tionally, the muscle may be shredded in a natural way.
`Therefore the effect results in body shaping and/or contour(cid:173)
`ing may be significantly improved.
`The method causes the circumferential reduction i.e. a
`reduction of the size of the treated body area. The method is
`mostly indicated for the regions with cellulite, especially for
`buttocks, abdomen, hips, thighs or arms. However, the
`indication is not limited to the mentioned regions and the 40
`method may be used for stimulation of any other body area.
`The present invention discloses the advanced approaches
`in aesthetic applications, e.g. for cellulite treatment and/or
`body shaping. Combined methods of treatment by electro(cid:173)
`magnetic field and treatment by magnetic field are used. The 45
`electromagnetic field may include treatment by radiofre(cid:173)
`quency, infrared or optical waves. The magnet treatment
`may be provided by permanent magnets, electromagnetic
`devices generating a static magnetic field or time-varying
`magnetic devices. In the preferred application the treatment 50
`by a pulsed magnetic field and radiofrequency treatment
`may be combined. However the application is not limited by
`the recited combination so the combined method may
`include magnet treatment and any treatment by electromag(cid:173)
`netic field, e.g. light treatment, IR treatment or treatment by 55
`radio frequency waves, e.g. microwaves, short waves or long
`waves.
`The present invention discloses a method and a technical
`solution of application of different approaches of aesthetic
`treatments, e.g. magnet treatment and radiofrequency treat- 60
`ment. U.S. patent application Ser. No. 14/278,756 incorpo(cid:173)
`rated herein by reference describes a device which may be
`used. In an alternative embodiment the radiofrequency treat(cid:173)
`ment device may exclude the balun transformer, or the balun
`transformer may be included in transmatch. The possible 65
`methods of treatment by combined methods are described
`below.
`
`35
`
`P
`EDDY -
`
`- "2 . si . d2 . f2
`6-k·p·D
`
`,
`
`Eq. 1
`
`where: PEDDY is power loss per unit mass (W·kg- 1
`); BP is the
`peak of magnetic field (T); f is frequency (Hz); d is 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; p
`is the resistivity of material (Q·m); D is the density of
`material (kg·m3
`).
`The individual insulation of each wire reduces 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 coil, which will serve as a magnetic
`field generator. The coil provides an improvement in the
`efficiency of energy transfer in the LC resonant circuit and
`also reduces or eliminates unwanted thermal effects.
`The coil may have a planar coil shape where the indi(cid:173)
`vidually insulated wires may have cross-section wires with
`conductor diameter less than 3 mm even more preferably
`less than 0.5 mm and most preferably less than 0.05 mm.
`The wires are preferably made of materials with higher
`density and higher resistivity e.g. gold, platinum or copper.
`The diameters of the single wires should be minimal. On the
`other hand the total diameter should be maximal because of
`inverse proportion between the cross-section of all wires
`forming the coil and the electrical resistance. Therefore the
`ohmic part of the heat is then lower. Eq. 2 describes power
`loss of the coil:
`
`p· ~ ./2
`PR= _s __
`m
`
`Eq. 2
`
`Where: PR is the power loss heat dissipation (W); p is the
`resistance (Q·m); 1 is the length of wire (m); Sis the surface
`area (m2
`); 1 is the current (A) and mis 1 kg of wire material.
`Total power loss is (Eq.3):
`
`Eq. 3
`
`Where: Proris the total power losses (W·kg- 1
`); PEDDY is the
`power dissipation of eddy currents (W·kg- 1
`); PR is the power
`loss heat dissipation (W·kg- 1
`).
`Dynamic forces produced by current pulses passing
`through the wires of the coil cause vibrations and unwanted
`noise. The individual insulated wires of the coil may be
`impregnated under pressure so as to eliminate air bubbles
`between the individual insulated wires. The space between
`wires can be filled with suitable material which causes
`
`LUMENIS EX1001
`Page 13
`
`

`

`US 10,124,187 B2
`
`5
`
`5
`unification, preservation and electric insulation of the sys(cid:173)
`tem. Suitable rigid impregnation materials like resin, and
`elastic materials like PTE can be also used. With the coil
`provided as a solid mass, the vibrations and resonance
`caused by movements of the individual insulated wires are
`suppressed. Therefore noise is reduced.
`The coil may be attached to the case of the applicator,
`such as a hand held applicator of the magnetic stimulation
`device; built-in applicator in e.g. chair, bed; or stand-alone
`applicator e.g. on mechanical fixture. The attachment may
`be provided by an elastic material e.g., silicone, gum; or
`other flexible manner. Connection with the coil of the
`applicator's case can be ensured by several points. The
`several fastening points ensure the connection of the coil to 15
`the casing by flexible material so that the main part of the
`coil and the main part of the casing of applicator are spaced
`apart. The spacing should be at least 0.1 mm so that air can
`easily flow. The gap between the coil and the casing can be
`used either for spontaneous or controlled cooling. The coil 20
`may optionally be connected to the case of the applicator by
`only one fastening point. The fastening points eliminate
`vibrations of wires which could be transferred to housing of
`the applicator and therefore reduce noise of the magnetic
`stimulation device.
`FIG. 2 is a cross-section of the magnetic applicator which
`allows better flow on the lower and upper sides of the coil
`and thus more efficient heat dissipation. The magnetic
`stimulation device includes a coil 10, the circuit wires 11 and
`the fastening points 12 for connection of the coil to the 30
`casing of the applicator (not shown). The fastening points 12
`are preferably made of flexible material however the rigid
`material may be used as well. The fastening points 12 may
`be located on the outer circumferential side of the coil.
`However, alternatively it is possible to put these fastening
`points to a lower or upper side of the coil.
`The fastening points 12 connect the coil to the case of the
`applicator in at least one point. The fastening points 12
`maintain the coil and the main part of the case of the
`applicator spaced apart so that fluid (which may be air or any
`liquid) can flow between them. At least one blower 13 can
`be placed around the circumference of the coil, or perpen(cid:173)
`dicular to the coil. The blower can be any known kind of
`device for directing the fluid e.g. outer air directed into the
`case of the applicator. This arrangement of the blower allows
`air to bypass the coil from upper and lower (patient's) sides.
`In still another embodiment the outer air can be cooled
`before directing into the case. The blower can have an inlet
`placed around the circumference of the coil for injecting air,
`to remove heat from the coil. A connecting tube (not shown)
`can ensure connection of the applicator 14 with the energy
`source and/or control unit of magnetic stimulation device.
`The connecting tube may also contain a conduit of the fluid.
`The arrows 15 indicate the air flow through the applicator
`14. This arrangement of the blower allows the air to bypass
`the coil from upper and lower (patient's) side. Outlet may be
`preferably placed on upper side of the casing. By placing the
`blower around the circumference of the coil instead of on the
`top/below the coil, the blower 13 does not interfere with the
`magnetic flux peak and therefore its lifespan and reliability
`is increased.
`FIG. 3 is an illustrative embodiment of a casing of the
`magnetic applicator. The overview drawing contains casing
`itself 16, which might contain an outlet 17 preferably placed
`on upper side of the casing 16. A connecting tube 18 may not
`only ensure connection of the applicator with the energy
`source and/or control unit of magnetic stimulation device,
`
`6
`but also connection to a source of the fluid; however the
`conduit of the fluid 19 may also be connected separately.
`FIG. 4A and FIG. 4B illustrate circuits for providing high
`power pulses to the stimulating coil. FIG. 4A shows a circuit
`for providing high power magnetic pulses. FIG. 4B shows a
`circuit for providing high power pulses.
`Existing magnetic stimulation devices achieve magnetic
`flux density of a few tenths to several Teslas. To achieve this
`level of magnetic flux density, the energy source used
`10 generates sufficient voltage. This voltage can reach thou(cid:173)
`sands of volts. In FIG. 4A the circuits for providing high
`power pulses to the stimulating coil contain a series con(cid:173)
`nection to the switch 22 and the coil 21. The switch 22 and
`the coil 21 together are connected in parallel with an energy
`storage device 20. The energy storage device 20 is charged
`by the energy source 23 and the energy storage device 20
`then discharges through the switching device 22 to the coil
`21.
`During second half-period of LC resonance, the polarity
`on the energy storage device 20 is reversed in comparison
`with the energy source 23. In this second half-period, there
`is a conflict between energy source 23, where voltage on
`positive and negative terminals is typically thousands of
`Volts. The energy storage device 20 is also charged to the
`25 positive and negative voltage generally to thousands of
`Volts. As a result, there is in the circuit, consequently, twice
`the voltage of the energy source 23. Hence the energy source
`23 and all parts connected in the circuit are designed for a
`high voltage load. Therefore, the protective resistors and/or
`protection circuitry 24 must be placed between energy
`source 23 and energy storage device 20. As a result a large
`amount of energy is transformed to undesired heat in the
`protective resistors and/or protection circuitry 24.
`FIG. 4B shows a circuit for providing high power pulses
`35 for improved function of the magnet stimulation device. The
`coil 31 and an energy storage device 30 are connected in
`series and disposed in parallel to the switch 32. The energy
`storage device 30 is charged through the coil 31. To provide
`an energy pulse, controlled shorting of energy source 33
`40 takes place through the switch 32. In this way the high
`voltage load at the terminals of the energy source 33 during
`the second half-period of LC resonance associated with
`known devices is avoided. The voltage on the terminals of
`energy source 33 during second half-period of LC resonance
`45 is a voltage equal to the voltage drop on the switch 32.
`The switch 32 can be any kind of switch such as diode,
`MOSFET, JFET, IGBT, BJT, thyristor or their combination.
`Depending on the type of component the load of energy
`source 33 is reduced to a few Volts, e.g., 1-10 volts.
`50 Consequently, it is not necessary to protect the energy source
`33 from a high voltage load, e.g., thousands of Volts. The use
`of protective resistors and/or protection circuits is reduced or
`eliminated. The present designs simplify the circuits used,
`increase efficiency of energy usage and provide higher
`55 safety.
`FIG. 5 show an exponential voltage drop in the energy
`storage device. Energy savings during time-varying mag(cid:173)
`netic therapy may be characterized by reduced voltage drop
`in the energy storage device between the first, second and
`60 subsequent maximums of the resonant oscillation. The mag(cid:173)
`nitude of the individual voltage oscillations is exponentially
`dampened up to establishing the energy balance. This allows
`increasing the maximum possible frequency/repetition rate
`of magnetic pulses, since the frequency/repetition rate is
`65 dependent on the speed with which it is possible to recharge
`the energy storage device. Since the energy storage device is
`recharged by the amount of energy loss during the previous
`
`LUMENIS EX1001
`Page 14
`
`

`

`US 10,124,187 B2
`
`7
`pulse, it is possible to increase the frequency/repetition rate
`of the device up to hundreds of magnetic pulses per second
`without the need to increase the input power. The voltage
`drop between any of the successive amplitudes is not higher
`than 21 %, even more preferably not higher than 14% and
`most preferably not higher than 7%.
`The device can be used for treatment/successive treat(cid:173)
`ments in continual, interrupted or various duty cycle regime.
`The duty cycle may be higher than 10%, which means
`interrupted regime with the ratio up to 1 active to 9 passive
`time units. The ratio may possibly change during the
`therapy. The device enables operation defined by the peak to
`peak magnetic flux density on the coil surface at least 3 T,
`more preferably at least 2.25 T, most preferably at least 1.5
`T at repetition rates above 50 Hz, more preferably at
`repetition rates above 60 Hz, even more preferably at
`repetition rates above 70, most preferably at repetition rates
`above 80 Hz with treatment/successive treatments lasting
`several seconds or longer, for example, for at least 5, 10, 30,
`60, 120 or 240 seconds, or longer. The total power con(cid:173)
`sumption is below 1.3 kW and the width of pulses is in the
`range of hundreds of µs.
`The device enables achieving repetition rates above 100
`Hz, more preferably repetition rates above 150 Hz, most
`preferably repetition rates above 200 Hz with the magnetic 25
`flux density providing a therapeutic effect on neurons and/or
`muscle fibers and/or endocrine cells (e.g. at least partial
`muscle contraction, action potential in cell).