I 1111111111111111 1111111111 111111111111111 111111111111111 1111111111 11111111
`USO 10610696B 1
`
`c12) United States Patent
`Peled
`
`(10) Patent No.: US 10,610,696 Bl
`(45) Date of Patent:
`Apr. 7, 2020
`
`(58) Field of Classification Search
`CPC .......... A61N 1/06; A61N 1/403; A61B 5/053;
`A61B 5/0538; A61B 5/4519
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`(54) APPARATUS AND METHOD FOR TREATING
`BIOLOGICAL TISSUE
`
`(71) Applicant: Yona Peled, Kiryat Tivon (IL)
`
`(72)
`
`Inventor: Yona Peled, Kiryat Tivon (IL)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 601 days.
`
`(21) Appl. No.: 15/168,751
`
`(22) Filed:
`
`May 31, 2016
`
`Related U.S. Application Data
`
`4,989,605 A *
`
`7,503,927 Bl*
`
`2/1991 Rossen .............. A61N 1/36021
`128/907
`3/2009 Vetanze ............... A61N 1/0408
`607 /115
`2013/0289679 Al * 10/2013 Eckhouse .............. A61N 1/403
`607/102
`A61B 5/0537
`600/547
`
`2014/0039341 Al *
`
`2/2014 Bohorquez
`
`(60)
`
`Provisional application No. 62/168,875, filed on May
`31, 2015.
`
`* cited by examiner
`
`(51)
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A61N 1140
`A61N 1104
`A61N 1136
`A61N 1132
`A61N 2100
`A61N 5106
`A61N 5/067
`(52) U.S. Cl.
`CPC ........... A61N 11403 (2013.01); A61N 110452
`(2013.01); A61N 110456 (2013.01); A61N
`110484 (2013.01); A61N 11328 (2013.01);
`A61N 1136014 (2013.01); A61N 21008
`(2013.01); A61N 510625 (2013.01); A61N
`2005/067 (2013.01)
`
`Primary Examiner - Kaitlyn E Smith
`Assistant Examiner - Tigist S Demie
`(74) Attorney, Agent, or Firm - Roach Brown McCarthy
`& Gruber, P.C.; Kevin D. McCarthy
`
`(57)
`
`ABSTRACT
`
`Some embodiments relate to a 2D array/chain of basic units
`where each basic unit is individually addressable. Each basic
`unit may include a rigid or semi-rigid plate-e.g. of elec(cid:173)
`trically insulating material and an electrode ( e.g. ball elec(cid:173)
`trode )-for example, a ball-shaped electrode. The device
`may be used to treat biological tissue-e.g. to provide
`TEMS muscle stimulation.
`
`11 Claims, 39 Drawing Sheets
`
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`Allergan EX1106
`Page 1
`
`

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`U.S. Patent
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`Apr. 7, 2020
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`Allergan EX1106
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`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIGS. SA-SB each illustrate a non-limiting example of a
`
`SUMMARY OF EMBODIMENTS
`
`30
`
`DETAILED DESCRIPTION OF EMBODIMENTS
`
`1
`
`US 10,610,696 B 1
`
`
`2
`
`CROSS-REFERENCE TO RELATED
`
`APPLICATIONS
`
`Use of EMS/TENS pulse may improve circulation of
`
`BACKGROUND
`
`Some embodiments relate to the use of EMS/TENS pulses
`
`
`
`APPARATUS AND METHOD FOR TREATING
`
`
`
`
`between the Radiofrequency predefined sequential proce­
`
`BIOLOGICAL TISSUE
`
`
`
`
`dure of pulse trains allow the use of the same Electrodes for
`both treatments.
`
`lymph fluid.
`
`
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`
`This patent application claims the benefit of U.S. Provi­
`Some embodiments relate to the optional use of PEMT­
`
`
`
`
`
`
`
`sional Patent Application No. 62/168,875 filed on May 31,
`
`
`Pulsed Electro Magnetic Therapy, is for broken Bones
`
`
`2015, which is incorporated herein by reference in its
`
`Wound Therapy, Pain Relief.
`10
`entirety.
`Some embodiments relate to the option to add Vibration
`
`
`
`
`
`
`to the Applicator-for example, to help in the case of
`
`
`
`
`Increases metabolism of fat cells and/or to improves skin
`
`
`texture, and/or to increase skin elasticity and/or to stimulates
`The following issued United States patents and Unites
`
`
`
`
`lymphatic and blood circulation
`
`
`
`
`
`States patent publications provide potentially relevant back-15
`Different embodiments of the invention include one or
`
`
`
`
`
`
`
`
`ground material, and are all incorporated by reference in
`
`
`
`
`
`more of the following features (i.e. any combination of the
`
`
`
`their entirety: U.S. Pat. Nos. 5,660,836, 5,873,849, 6,662,
`
`
`
`
`features below ( or portions thereof) are within the scope of
`
`
`
`054, 6,662,054, 7,014,639, 8,014,878, 8,014,878, 8,172,835,
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`embodiments of the invention:
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`8,211,097, 8,813,756, 9,314,293, us 20030187488, us
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`20060259112, us 20070179482, us 20070239075, us 20
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`20100016849, us 20100160782, us 20100198199, us
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`20120226214, us 20120239120, us 20120310311, us
`FIGS. 1-6 are block diagrams of systems and apparatus
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`according to some embodiments of the invention.
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`20130053929, us 20130137918, us 20130226269, us
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`20130245727, us 20130282085, us 20130331914, us
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`FIG. 7 illustrates waveform diagram.
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`2013178764, us 20140213844, us 20140249609, us 25
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`20150088224, us 20160129273, us 20160129274, us
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`single basic unit.
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`20160121112, U.S. Pat. No. 6,662,054, US 20160129274,
`FIG. 9 is an example of 2D array/chain of basic units.
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`US 20160121135 US20160129273, US20160129279. U.S.
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`FIG. 10-12, 16-26 illustrate different form factors of a
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`Pat. No. 8,014,878, US20160136462, US20160129274
`sleeve.
`FIGS. 13-14 illustrate arrangements for electrodes.
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`FIG. 15 describes a protocol for delivering energy to
`biological tissue,
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`Embodiments of the invention relate to a wearable device
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`FIG. 27A-27J relate to embodiments where a plurality of
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`for delivering energy to biological tissue.
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`basic units are connected together ( e.g. in a two-dimensional
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`In different embodiments, the invention may relate to one
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`35 array of units-for example, addressable).
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`or more of (i) methods and apparatuses for medical and/or
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`FIG. 28A illustrates basic chain board options for 2 phase
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`aesthetic treatment (ii) a therapeutic wearable sleeve device
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`and/or 3 phase sleeve applicators.
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`for self-contained treatments, (iii) responding to biological
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`FIG. 28B describes a method of temperature simultaneous
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`feedbacks, (iii) noninvasive with robotic autonomous func­
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`measurements from the whole treatment area for 2 phase
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`tional Skin interaction, fully independent and does not need
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`40 and/or 3 phase sleeve applicators
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`a direct operator during treatments.
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`Apparatuses described herein can be self-contained, light­
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`weight-for example, having the form factor of a wearable
`The claims below will be better understood by referring to
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`sleeve.
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`In some non-limiting examples, apparatuses described
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`45 the present detailed description of example embodiments
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`herein may comprise at least three components: (i) a Main
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`with reference to the figures. The description, embodiments
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`Unit that includes the main control and/or houses a user
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`and figures are not to be taken as limiting the scope of the
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`interface (e.g. GUI) and/or some or all of modular drivers
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`claims. It should be understood that not every feature of the
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`(e.g. that will be described later), (ii) the safety wearable
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`presently disclosed methods, apparatuses, and computer
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`control that, for example, allows the user to pause or stop the
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`50 readable media having stored thereon computer code for
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`delivery of energy from the apparatuses, and (iii) a sleeve
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`treating biological tissue is necessary in every implementa­
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`applicator part.
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`tion. It should also be understood that throughout this
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`Applications include but are not limited to (i) warming
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`disclosure, where a process or method is shown or
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`treatment of sport injuries (ii) pain relief; (iii) loose and/or
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`described, the steps of the method may be performed in any
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`electrical muscles stimulation ( e.g. to strength improve
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`55 order or simultaneously, unless it is clear from the context
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`overall body strength) (iv) for use in cases of mild to
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`that one step depends on another being performed first. As
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`moderate fat reduction (v) skin tightening (vi) corrective
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`used throughout this application, the word "may" is used in
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`forming body contouring therapy (vii) cellulite reduction
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`a permissive sense (i.e., meaning "having the potential to"),
`treatments.
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`rather than the mandatory sense (i.e. meaning "must").
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`The therapy may be based on multi-technology deliv-60 Idea A In some embodiments, and as illustrated in FIG. 1,
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`ery---e.g. delivered simultaneously or sequentially ( e.g. the Apparatuses described herein is divided to three major
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`according to a predefined sequential procedure that depends parts (not every part is required): the Main Unit that includes
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`on the real time monitoring of bio feedback
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`the main Control parameters. and the GUI and all the modular drivers
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`Some embodiments relate to
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`that will be use of radio frequency multi described later, the Safety wearable control that
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`channels and multiphase with Laser Lipolysis
`allow the user to STOP the delivery at the same 65 of Energy from the
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`time will have the Efficacy of combined
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`Apparatuses, Skin Tightening and and the new Inventive Applicator part that is
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`the center part of this invention.
`Fat Reduction.
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`US 10,610,696 B 1
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`3
`Idea B In some embodiments, Methods and Apparatuses
`for Medical and Aesthetics Therapeutic Wearable Sleeve
`device for self-contained treatments predefined and depend
`on biological feedbacks, Noninvasive with Robotic Autono(cid:173)
`mous
`functional Skin
`Interaction,
`fully
`independent 5
`Robotic, does not need a direct operator during treatment.
`Based on the Predefined parameters and the Biofeedback the
`Main Control start to deliver the Treatment Energy on all
`over the aria of the Wearable Applicator in a self-contained
`procedure so it cover all area in uniform circulation and keep 10
`the skin temperature in a steady level under the allowed
`threshold,
`Idea C In some embodiments, The Main Control Algo(cid:173)
`rithm cause the Energy delivery to be adaptive, so it can be 15
`change during the area sequential procedure pass and even
`skip over parts of it depend on the local Temperature
`feedback, it will stop the Treatment in case of safety
`detection or predefined end of procedure.
`Idea D In some embodiments, The Main Control RF 20
`delivery Algorithm works at nonlinear area pass, it jumps
`from one local area part to other local area part while
`jumping over the neighbor area part, in this way the all skin
`area heating under the Applicator become uniformity heated
`to the target temperature, the Diode Lipolysis LLLT (Low 25
`Level Laser Therapy) works during all of the treatment time.
`Idea E In some embodiments, apparatuses described
`herein can be self-contained, lightweight, and wearable.
`Idea F In some embodiments, For use in case of Warming
`Sport Injury the use of EMS/TENS pulses between the RF 30
`predefined sequential procedure of pulse trains allow the use
`of the same Electrodes for both treatments, the Diode
`Lipolysis LLLT (Low Level Laser Therapy) works during
`all of the treatment time
`Idea G In some embodiments, For use in case of Pain 35
`Relief the use of EMS/TENS pulses between the RF pre(cid:173)
`defined sequential procedure of pulse trains allow the use of
`the same Electrodes for both treatments, the Diode Lipolysis
`LLLT (Low Level Laser Therapy) works during all of the
`treatment time
`Idea H In some embodiments, For use in case of loose
`and/or electrical Muscles Stimulation overall body the use of
`EMS/TENS pulses between the RF predefined sequential
`procedure of pulse trains allow the use of the same Elec(cid:173)
`trodes for both treatments
`For example the rectus obdominis, the external oblique,
`the internal oblique and the trans versusabdominis.
`Idea I In some embodiments, For use in case of mild to
`moderate Fat Reduction, the Diode Lipolysis LLLT (Low
`Level Laser Therapy) with multiphase RF will be used
`The use of Radiofrequency and Laser Lipolysis at the
`same time will have the Efficacy of combined Skin Tight(cid:173)
`ening and Fat Reduction
`The use of EMS/TENS pulses between the RF predefined
`sequential procedure of pulse trains allow the use of the 55
`same Electrodes for both treatments
`Idea J In some embodiments, For use in case of Skin
`Tightening, the Diode Lipolysis LLLT (Low Level Laser
`Therapy) with multiphase RF will be used
`The use of Radiofrequency and Laser Lipolysis at the 60
`same time will have the Efficacy of combined Skin Tight(cid:173)
`ening and Fat Reduction
`The use of EMS/TENS pulses between the RF predefined
`sequential procedure of pulse trains allow the use of the
`same Electrodes for both treatments
`Idea K In some embodiments, For use in case of Correc(cid:173)
`tive Forming body contouring therapy
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`4
`Diode Lipolysis LLLT (Low Level Laser Therapy) with
`multiphase RF will be used
`The use of Radiofrequency and Laser Lipolysis at the
`same time will have the Efficacy of combined Skin Tight(cid:173)
`ening and Fat Reduction
`The use of EMS/TENS pulses between the RF predefined
`sequential procedure of pulse trains allow the use of the
`same Electrodes for both treatments
`Idea L In some embodiments, For use in case of Cellulite
`Reduction Treatments Diode Lipolysis LLLT (Low Level
`Laser Therapy) with multiphase RF will be used The use of
`Radiofrequency and Laser Lipolysis at the same time will
`have the Efficacy of combined Skin Tightening and Fat
`Reduction
`Idea M In some embodiments, The Therapy based on
`multi technologic delivery at the same time or in a pre(cid:173)
`defined sequential procedure that depends on the Real Time
`Monitoring Bio Feedback parameters.
`Idea N In some embodiments, The safe control for effec(cid:173)
`tive Treatment, will be causing by biological feedbacks from
`the treatment area or by user control that placed on the safe
`wearable Sleeve unit on the user Arm, and will give the user
`the option to change the Treatment Level up or down or Stop
`the Energy delivery.
`Idea O In some embodiments, The use ofRadiofrequency
`and Laser Lipolysis at the same time will have the Efficacy
`of combined Skin Tightening and Fat Reduction.
`Idea P In some embodiments, The use of EMS/TENS
`pulses between the RF predefined sequential procedure of
`pulse trains allow the use of the same Electrodes for both
`treatments
`Idea Q In some embodiments, The intend of use will be
`in Medical Centers and in comfortable and relaxing Fitness
`room, sports activity Centers or Spa-like environment, pro(cid:173)
`vide a body contouring apparatus employed in cosmetic
`body contouring treatments such as, but not limited to, fat
`reduction, body circumference reduction, cellulite reduc(cid:173)
`tion, skin tightening and skin rejuvenation at a clinical or
`dedicated professional setting
`Idea Q In some embodiments, use of PEMT-Pulsed
`Electro Magnetic Therapy, is for broken Bones wound
`Therapy, Pain Relief using unipolar Magnetic pulses up to
`30 Hz, and for Pain case
`FIG. 1 is general block diagram including (i) a safety
`45 control Unit (ii) a main module (e.g. having the form factor
`of a wearable knapsack or having a table top or suitcase form
`factor); and (iii) an applicator module ( e.g. sleeve applicator
`module). For example, the applicator module comprises at
`least one or at least two applications---e.g. operating in
`50 parallel.
`FIG. 1 illustrates three modules (not all of which are
`required) including (i) an applicator module ( e.g. a sleeve
`and/or a portion thereof and/or a sheet (e.g. flat or curved
`sheet---e.g. flexible sheet)) comprising an array (e.g. 2-D
`array)) of electrode ( e.g. having rounded ends); (ii) a control
`module (e.g. including circuitry for addressing electrodes)
`and (iii) an optional safety module---e.g. including a 'stop
`switch'. For example, the main control unit may have a
`'suitcase' form factor-see, e.g. FIG. 26.
`FIG. 2 illustrates a schematic block diagram of optional
`safety module including a switch-see also FIG. 25. In this
`case the user can stop treatment by engaging the 'safe(cid:173)
`switch'
`FIG. 2 is a block diagram of a safety control module ( e.g.
`65 for a sleeve that is wearable on an arm). The safety control
`module comprises: (i) User Controls such as an UP and/or
`DOWN switches for raising or lowering an intensity of
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`40
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`US 10,610,696 B 1
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`5
`delivery energy; (ii) indicator(s) (e.g. LED indicators) and/
`or an optional LCD; and (iii) a 'STOP' switch---e.g. a panic
`button that allows the user to stop the system at any time and
`to summon the operator.
`FIG. 3 is a block diagram of various elements of an energy 5
`delivery device. As shown in FIG. 4, in some embodiments,
`the device includes multiple applicators.
`FIG. 3 is a block diagram of the main control unit ( e.g.
`having any form factor-e.g. as a table top unit or as a
`knapsack). For example, the block diagram includes: (ii) 10
`GUI PC and LCD display module; (ii) Main Control Unit
`include FPGA and Safety interface module (iii) Multichan(cid:173)
`nel and Multiphase Variable Radiofrequency drive for # n
`modules (iv) Power Radiofrequency Modulesxn (Sine
`waves) (v) EMS/TENS Muscle stimulation and Nerve 15
`stimulation module (vi) Soft Leasers Diode for Lipolysis,
`multichannel drive module (in visible and Near-IR and IR
`wave longs) (vii) Ultrasound drive module (Optional) (vii)
`PEMT-Pulsed Electro Magnetic Therapy stimulation drive
`module (Optional) (viii) Cooling drive and FAN module and 20
`(ix) Real Time Monitoring Bio Feedback parameters (x)
`System He