I 1111111111111111 1111111111 1111111111 111111111111111 111111111111111 IIII IIII
`
`USO 10806943B2
`
`(IO) Patent No.: US 10,806,943 B2
`
`c12) United States Patent
`
`(45)Date of Patent:
`Sokolowski
`
`Oct. 20, 2020
`
`(54)DEVICE FOR REPETITIVE NERVE
`
`
`STIMULATION IN ORDER TO BREAK
`
`DOWN FAT TISSUE MEANS OF INDUCTIVE
`MAGNETIC FIELDS
`
`(58)Field of Classification Search
`
`
`CPC ............. A61N 1/40; A61N 2/006; A61N 2/02
`
`
`
`See application file for complete search history.
`
`(56)
`
`
`
`(71) Applicant: BTL Medical Technologies S.R.O.,
`Prague (CZ)
`
`
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`(72)Inventor: Tobias Sokolowski, Pullach im Isartal
`
`
`
`
`
`(DE)
`
`(73)Assignee: BTL Medical Technologies S.R.O.,
`
`
`
`
`Prague (CZ)
`
`4/1972 MacLean
`3,658,051 A
`
`10/1975 Kraus et al.
`
`3,915,151 A
`12/1980 Whalley
`
`4,237,898 A
`6/1984 Fellus
`4,454,883 A
`6/1984 Pescatore
`
`4,456,001 A
`
`6/ l 9 87 Pauli et al.
`
`4,674,505 A
`(Continued)
`
`( * ) Notice:Subject to any disclaimer, the term ofthis
`
`
`
`
`
`patent is extended or adjusted under 35
`
`
`U.S.C. 154(b) by O days.
`
`
`
`(21) Appl. No.: 16/415,927
`
`(22)Filed:
`May 17, 2019
`
`(65)
`
`
`
`Prior Publication Data
`
`CN
`DE
`
`FOREIGN PATENT DOCUMENTS
`
`201906360 U 7/2011
`
`1118902 B 12/1961
`(Continued)
`
`OTHER PUBLICATIONS
`
`
`
`Abulhasan, J.F., et al., "Peripheral Electrical and Magnetic Stimu­
`
`
`US 2019/0336783 Al Nov. 7, 2019
`
`lation to Augment Resistance Training," Journal of Functional
`
`
`
`Morphology and Kinesiology, 1(3):328-342, (Sep. 2016).
`
`
`
`
`Related U.S. Application Data
`
`(Continued)
`
`(30)
`
`
`
`(63) Continuation of application No. 14/412,875, filed as
`
`
`
`
`
`
`application No. PCT/IB2013/001896 on Jul. 2, 2013.
`Primary Examiner - Christine H Matthews
`
`
`
`
`
`(74)Attorney, Agent, or Firm - Sterne, Kessler,
`
`Goldstein & Fox P.L.L.C.
`
`Jul. 5, 2012 (DE) ........................ 10 2012 013 534
`(57)
`ABSTRACT
`
`
`
`
`
`Foreign Application Priority Data
`
`
`
`(51)Int. Cl.
`A61N 2102
`
`A61N 2100
`
`(2006.01)
`(2006.01)
`(2006.01)
`
`A device for repetitive nerve stimulation for development of
`
`
`
`
`
`
`muscle using inductive magnetic fields, having a stimulation
`
`
`coil replaceably attached to a stand and accommodated in a
`
`
`
`plastic housing, and a pulse generator for electrically actu­
`A61N 1140
`(52)U.S. Cl.
`ating the stimulation coil.
`CPC ................. A61N 2102 (2013.01); A61N 1140
`
`
`
`
`(2013.01); A61N 21006 (2013.01)
`
`
`
`29 Claims, 8 Drawing Sheets
`
`
`
`LUMENIS EX1001
`Page 1
`
`

`

`US 10,806,943 B2
`Page 2
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`4,850,959 A
`5,067,940 A
`5,718,662 A
`5,766,124 A
`5,782,743 A
`5,807,232 A
`5,984,854 A
`6,063,108 A
`6,086,525 A
`6,099,459 A *
`
`7/1989 Find!
`11/1991 Liboff et al.
`2/1998 Jalinous
`6/1998 Polson
`7/1998 Russell
`9/1998 Espinoza et al.
`11/1999 Ishikawa et al.
`5/2000 Salansky et al.
`7/2000 Davey et al.
`8/2000 Jacobson
`
`9/2000 Abrams et al.
`6,117,066 A
`1/2001 Mould
`6,179,770 Bl
`4/2001 Lin
`6,213,933 Bl
`6,402,678 Bl
`6/2002 F ischell et al.
`6,418,345 Bl
`7/2002 Tepper et al.
`6,527,694 Bl
`3/2003 Ishikawa et al.
`4/2009 Simon
`7,520,849 Bl
`10/2009 Farone
`7,608,035 B2
`6/2010 Epstein
`7,744,523 B2
`5/2011 Peterchev
`7,946,973 B2
`8/2011 Aho
`7,998,053 B2
`3/2015 Ron et al.
`8,979,727 B2
`3/2017 Ladman et al.
`9,586,057 B2
`5/2017 Ladman et al.
`9,636,519 B2
`3/2018 Schwarz et al.
`9,919,161 B2
`4/2018 Schwarz et al.
`9,937,358 B2
`11/2018 Schwarz et al.
`10,124,187 B2
`4/2019 Schwarz et al.
`10,245,439 Bl
`2001/0031906 Al
`10/2001 Ishikawa et al.
`2003/0050527 Al
`3/2003 Fox et al.
`2003/0158585 Al
`8/2003 Burnett
`7/2006 Roh wedder
`2006/0152301 Al
`8/2006 Mo
`2006/0187607 Al
`2006/0287566 Al* 12/2006 Zangen
`
`2007 /0083237 Al
`2008/0249350 Al
`2008/0306325 Al
`2008/0306326 Al
`2009/0018384 Al
`2009/0108969 Al
`2010/0036368 Al
`2010/0081971 Al
`2010/0087699 Al
`2010/0121131 Al
`2010/0152522 Al
`2010/0160712 Al
`2010/0179372 Al
`2010/0222629 Al
`2010/0309689 Al
`2010/0331603 Al
`2011/0021863 Al
`2011/0077451 Al
`2011/0130618 Al
`2012/0053449 Al
`2012/0172653 Al
`2012/0302821 Al
`2012/0310033 Al
`2013/0030239 Al
`2013/0053620 Al
`2013/0123568 Al
`2013/0123764 Al
`2013/0123765 Al
`2013/0137918 Al
`2013/0150653 Al
`2013/0331637 Al
`2014/0148870 Al
`2014/0330067 Al
`2014/0371515 Al
`2015/0025299 Al
`2015/0123661 Al
`2015/0133717 Al
`2015/0157873 Al*
`
`4/2007 Teruel
`10/2008 Marchitto et al.
`12/2008 Burnett et al.
`12/2008 Epstein
`1/2009 Boyden et al.
`4/2009 Sims et al.
`2/2010 England et al.
`4/2010 Allison
`4/2010 Peterchev
`5/2010 Mathes
`6/2010 Roth et al.
`6/2010 Burnett et al.
`7/2010 Glassman
`9/2010 Burnett et al.
`12/2010 Coulson
`12/2010 Szecsi
`1/2011 Burnett et al.
`3/2011 Marchitto et al.
`6/2011 Ron et al.
`3/2012 Moses et al.
`7/2012 Chornenky et al.
`11/2012 Burnett
`12/2012 Muntermann
`1/2013 Weyh et al.
`2/2013 Susedik et al.
`5/2013 Hamilton et al.
`5/2013 Zarsky et al.
`5/2013 Zarsky et al.
`5/2013 Phillips et al.
`6/2013 Borsody
`12/2013 Greff
`5/2014 Burnett
`11/2014 Jordan
`12/2014 John
`1/2015 Ron et al.
`5/2015 Yui et al.
`5/2015 Ghiron et al.
`6/2015 Sokolowski
`
`A61N 2/02
`128/897
`
`A61N 2/02
`600/15
`
`A61N 2/006
`600/14
`
`2015/0216719 Al
`2015/0328475 Al
`2015/0367141 Al
`2016/0030763 Al
`2016/0250494 Al
`2017/0001024 Al
`2017/0001025 Al
`2017/0001029 Al
`2017/0001030 Al
`2017 /0072212 Al
`2017/0106201 Al
`2017/0120067 Al
`2018/0001106 Al
`2018/0125416 Al
`2018/0236254 Al
`
`8/2015 Debenedictis et al.
`11/2015 Kim et al.
`12/2015 Goetz et al.
`2/2016 Midorikawa et al.
`9/2016 Sakaki et al.
`1/2017 Prouza
`1/2017 Schwarz et al.
`1/2017 Pribula et al.
`1/2017 Pribula et al.
`3/2017 Ladman et al.
`4/2017 Schwarz et al.
`5/2017 Prouza
`1/2018 Schwarz
`5/2018 Schwarz et al.
`8/2018 Schwarz et al.
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`DE
`EP
`JP
`WO
`WO
`
`3205048 Al
`3610474 A
`0459401 Al
`2017518857 A
`03/103769 Al
`WO-2015179571 Al
`
`8/1983
`10/1986
`12/1991
`7/2017
`12/2003
`11/2015
`
`OTHER PUBLICATIONS
`
`Bachasson, D., et al., "Quadriceps Function Assessment Using an
`Incremental Test and Magnetic Neurostimulation: a Reliability
`Study," Journal of Electromyography and Kinesiology, 23(3):649-
`658, Elsevier, England, (Jun. 2013).
`Barker, A. T, "An Introduction to the Basic Principles of Magnetic
`Nerve Stimulation," Journal of Clinical Neurophysiology, 8(1):26-
`37, Lippincott Williams & Wilkins, United States, (Jan. 1991).
`Basic Protocol of Salus, Talent with Incontinence Chair, REMED,
`1 page.
`Behrens, M., et al., "Repetitive Peripheral Magnetic Stimulation (15
`Hz RPMS) of the Human Soleus Muscle did not Affect Spinal
`Excitability," Journal of Sports Science and Medicine, 10( 1 ):39-44,
`Dept. of Sports Medicine, Medical Faculty of Uludag University,
`Turkey (Mar. 2011).
`Beilin, G., et al., "Electromagnetic Fields Applied to the Reduction
`of Abdominal Obesity," Journal of Cosmetic & Laser Therapy,
`14(1):24-42, Informa Healthcare, England, (Feb. 2012).
`Bustamante, V., et al., "Muscle Training With Repetitive Magnetic
`Stimulation of the Quadriceps in Severe COPD Patients," Respira-
`tory Medicine, 104(2):237-245, Elsevier, England, (Feb. 2010).
`Bustamante, V., et al., "Redox Balance Following Magnetic Stimu-
`lation Training in the Quadriceps of Patients With Severe COPD,"
`Free Radical Research, 42(11-12):939-948, Inforrna Healthcare,
`England, (Nov. 2008).
`Caress, J.B., et al., "A Novel Method of Inducing Muscle Cramps
`Using Repetitive Magnetic Stimulation," Muscle Nerve, 23( 1 ): 126-
`128, John Wiley & Sons, United States, (Jan. 2000).
`Clinical Application of Electro Magnetic Stimulation, Salus-Talent,
`Korea Society of interventional Muscle and Soft Tissue Stimulation
`Therapy, CR Technology, 141 pages.
`Course in Physical Therapy, Presentation, Jan. 4, 2013, 156 pages.
`CR Technology, Salus-Talent, Technical File of Electro-magnetic
`Stimulator, Document No. TF-005, 2008, 241 pages.
`CR Technology, Technology for Health and Business for Human
`Being, investor relations, 2008, 21 pages.
`Effective PEMF Magnetic Fat Reduction Slimming Body Beauty
`Salon Machine (PEMF Star), Wolfbeauty 1980, PEMF STAR,
`China, Retrieved from the Internet: (URL: https://www.ec2l.com/
`product-details/Effective-PEMF-Magnetic-Fat-Reduction--8928746.
`html), 2019, 5 pages.
`FMS Tesla Stym-AKCE, Medila Cenova nabidika, Price offer c.
`191, 24 pages.
`Goetz, S.M., et al., "Coil Design for Neuromuscular Magnetic
`Stimulation Based on a Detailed 3-D Thigh Model," IEEE Trans-
`actions on Magnetics, 50(6): 10, IEEE, (Jun. 2014).
`
`LUMENIS EX1001
`Page 2
`
`

`

`US 10,806,943 B2
`Page 3
`
`(56)
`
`References Cited
`
`OTHER PUBLICATIONS
`
`Gorodnichev, R.M., "Magnetic Stimulation of Muscles as New
`Method to Enhance Their Strength," Velikie Luki State Academy of
`Physical Culture and Sport, Velikie Luki, 2016, 5 pages.
`Hanmegard, C.H., et al., "Quadriceps Strength Assessed by Mag(cid:173)
`netic Stimulation of the Femoral Nerve in Normal Subjects,"
`Clinical Physiology and Functional Imaging, 24(5):276-280, Blackwell,
`England, (Sep. 2004).
`Han, T.R., et al., "Magnetic Stimulation of the Quadriceps Femoris
`Muscle: Comparison of Pain With Electrical Stimulation," Ameri(cid:173)
`can Journal of Physical Medicine & Rehabilitation, 85(7):593-599,
`Lippincott Williams & Wilkins, United States, (Jul. 2006).
`Hasala, 0., et al., Case Study of Treating Acute Ankle Distortion
`Using TMS, Charles University, Faculty of Physical Education and
`Sports, Prague, Czech Republic, 4 Pages.
`Increasing Physiotherapy Presence in Cosmetology, Spa Inspira(cid:173)
`tions, Jan. 2012, pp. 34-35.
`Iskra Medical, Magneto System, 2012, 2 pages.
`Katuscakova, Z.L., et al., High Induction Magnet Therapy in
`Rehabilitation, Department of Physiactric Rehabilitation, 2012, 72
`pages.
`Lampropoulou, S.I., et al., "Magnetic Versus Electrical Stimulation
`in the Interpolation Twitch Technique of Elbow Flexors," Journal of
`Sports Science and Medicine, 11(4):709-718, Dept. of Sports Medi(cid:173)
`cine, Medical Faculty of Uludag University, Turkey (Dec. 2012).
`Lin, V.W., et al., "Functional Magnetic Stimulation for Restoring
`Cough in Patients With Tetraplegia," Archives of Physical Medicine
`and Rehabilitation, 79(5):517-522, W.B. Saunders, United States,
`(May 1998).
`Lin, V.W., et al., "Functional Magnetic Stimulation of Expiratory
`Muscles: a Noninvasive and New Method for Restoring Cough,"
`Journal of Applied Physiology (1985), 84(4):1144-1150, American
`Physiological Society, United States, (Apr. 1998).
`Madariaga, V.B., et al., "[Magnetic Stimulation of the Quadriceps:
`Analysis of 2 Stimulators Used for Diagnostic and Therapeutic
`Applications]," Archivos De Bronconeumologia, 43(7):411-417,
`Elsevier Espana, Spain, (Jul. 2007).
`MAG and MORE Gmbh, Magnetic and Life Science System, Power
`Mag, 12 Pages.
`Mag Venture, Magnetic Stimulation, Accessories Catalogue, Acces(cid:173)
`sories Catalogue, 2011, 54 pages.
`MagVenture, MagPro® by MagVenture®, Versatility in Magnetic
`Stimulation, World Leading Transcranial Magnetic Stimulation
`Systems, 2011, 6 Pages.
`Mulholland, R.S., Synergistic Multi-polar Radiofrequency and Pulsed
`Magnetic Fields in the Non-Invasive Treatment of Skin Laxity and
`Body Contouring, 4 pages.
`Neuro Star, TMS Therapy, Bringing Hope to Patients with Depres(cid:173)
`sion, 2013, 6 Pages.
`Neurosoft, Ivanovo, Since 1992, Magnetic Stimulator, Neuro-MS,
`Technical Manual, Neurosoft Ltd, Ivanovo, Russia, 2006, 67 Pages.
`Nexstim NBS System, Navigated Brain Stimulation, Noninvasive,
`direct cortical mapping, 2012, 5 Pages.
`Obsluze, N.K.,Usage Instructions, User's Manual, Device for high(cid:173)
`induction magnetic stimulation of type designation:Saluter Moti,
`2016, 88 Pages.
`Operating Manual: Magstim D702 Coil, MOP06-EN, Revision 01,
`The Magstim Company Limited, Feb. 2012, 14 Pages.
`Operating Manual: Magstim Magstim 2002
`, MOP0l-EN, Revision
`01, The Magstim Company Limited, Sep. 2011, 25 Pages.
`Operating Manual: Magstim, Magstim Alpha Coil Range, MOPll(cid:173)
`EN, Revision 01, Oct. 2012, 18 Pages.
`Operating Manual: Magstim, Magstim Bistim2
`, MOP02-EN, Revi(cid:173)
`sion, The Magstim Company Limited, 01, Sep. 2011, 27 Pages.
`Operating Manual, Magstim, Model 200, PIN 3001-01, Double
`70mm, Remote Coil, PIN 3190-00, The Magstim Company Lim(cid:173)
`ited, 2006, 32 pages.
`Operating Manual: Magstim R, 2nd, Generation Coil Family, 3100-
`23-02, Magstim Coils, The Magstim Company Limited, Nov. 2002,
`14 Pages.
`
`Operating Manual, Magstim R Air-Cooled Double 70mm Coil
`System, 1600-23-04, The Magstim Company Limited, 1999, 18
`Pages.
`Operating Manual: Magstim R, Bistim System, PIN 3234-23-01,
`The Magstim Company Limited, Nov. 2004, 30 Pages.
`Operating Manual: Magstim R, Coils & Accessories, 1623-23-07,
`Magstim Coils & Accessories, May 2010, 24 Pages.
`Operating Manual: Magstim, RAPID2, PIN 3576-23-09, The Magstim
`Company Ltd, Nov. 2009, 61 Pages.
`Operator's Manual: BTL Emsculpt, BTL Industries Ltd, United
`Kingdom, 2018, 35 pages.
`Operator's Manual: BTL, HPM-6000U, BTL Industries Ltd, United
`Kingdom, Dec. 2016, 36 pages.
`Papimi, For Scientific Research, Pap Ion Magnetic Inductor, Pre(cid:173)
`sentation, Magnetotherapeutic Device, Nov. 2009, 61 Pages.
`Podebradsky.K., et al., Clinical study of high-inductive electromag(cid:173)
`netic stimulator SALUS talent, 2010, 8 pages.
`Polkey M.I., et al., "Functional Magnetic Stimulation of the Abdomi(cid:173)
`nal Muscles in Humans," American Journal of Respiratory and
`Critical Care Medicine, 160(2):513-522, American Thoracic Soci(cid:173)
`ety, United States (Aug. 1999).
`Polkey, M.I., et al., "Quadriceps Strength and Fatigue Assessed by
`Magnetic Stimulation of the Femoral Nerve in Man," Muscle
`Nerve, 19(5):549-555, John Wiley & Sons, United States, (May
`1996).
`Quick Start Manuals, Magstim Super Rapid Plus Quick Start, Aalto
`TMS Laboratory, Aalto School of Science, 2013, 7 Pages.
`Salus Talent, a Vertice and Talos, Drott, 6 pages.
`Salus Talent, Deep Penetrating Electro-Magnetic Stimulator, CR
`Technology, 4 pages.
`Salus Talent, Deep Penetrating Electro-Magnetic Stimulator, Reha(cid:173)
`bilitation Medical Company, New choice, new satisfaction, Talent,
`4 pages.
`Salus Talent, Electro Magnetic Stimulator, CR Technology, 9 Pages.
`Salus Talent Pro, Specification, 2 pages.
`Salus, Talent Pro, The Birth of Salus Talent Pro inspired by 10 Years
`of Experience, Specification, Rehabilitation Medical Company,
`Slimon, 2 pages.
`Salus, Talent Pro, The World's 1st Development 3 Tesla, 2Channel
`Magnetic field Therapy, Slimon , 10 pages.
`Salus Talent-A, Remed, User Guide, High Intensity Electro Mag(cid:173)
`netic Field Therapy, 2017, 37 pages.
`Salus-Talent, Device for Deep Electromagnetic Stimulation, Nowosc,
`Fizjoterapia, 6 Pages.
`DuoMAG Magnetic Stimulator, Alien Technik User Manuel, Jun.
`26, 2012, 48 pages, Version 2.1.
`Szecsi, J., et al., "A Comparison of Functional Electrical and
`Magnetic Stimulation for Propelled Cycling of Paretic Patients,"
`Archives of Physical Medicine and Rehabilitation, 90(4):564-570,
`W.B. Saunders, United States, (Apr. 2009).
`Szecsi, J., et al., "Force-pain Relationship in Functional Magnetic
`and Electrical Stimulation of Subjects With Paresis and Preserved
`Sensation," Clinical Neurophysiology, 121(9): 1589-1597, Elsevier,
`Netherlands, (Sep. 2010).
`Taylor, J.L, "Magnetic Muscle Stimulation Produces Fatigue With(cid:173)
`out Effort," Journal of Applied Physiology (1985), 103(3):733-734,
`American Physiological Society, United States, (Sep. 2007).
`Tesla Stym, Iskra Medical, Tone the inner muscle with FMS
`Functional Magnetic Stimulation, 2013, 4 pages.
`Uro Diagnostic Clinic, Now in UDC, Automated pelvic floor
`muscle training, QRS International AG, 16 Pages.
`User Guide: Mag Venture, Magpro family, MagPro R30, MagPro
`R30 with MagOption, MagPro Xl00, MagPro Xl00 with MagOp(cid:173)
`tion, MagPro software v.5.0, US-edition, MagPro family User
`Guide, 2010, 52 Pages.
`User Guide, Salus Talent Pro, REMED, High Intensity Electro
`magnetic Field Therapy -2 Channel, 2017, Version M-1.0.0, 45
`pages.
`User Guide, Salus Talent, REMED, High Intensity Electro magnetic
`Field Therapy, Version. M-1.0.0, 2017, 40 pages.
`User's Manual: BTL-6000, Super Inductive System Elite, BBTL
`Industries Ltd, United Kingdom, Sep. 2016, 36 pages.
`
`LUMENIS EX1001
`Page 3
`
`

`

`US 10,806,943 B2
`Page 4
`
`(56)
`
`References Cited
`
`OTHER PUBLICATIONS
`
`User Manual: Electro-magnetic Stimulator, Salus-Talent, Version
`1.00, Rehabilitation Medical Company, 2013, 34 Pages.
`User Manual: Regenetron Pro, System Information, Regenetron Pro
`User Manual, Nov. 2014, 7 Pages.
`Verges S., et al., "Comparison of Electrical and Magnetic Stimula(cid:173)
`tions to Assess Quadriceps Muscle Function," Journal of Applied
`Physiology (1985), 106(2):701-710, American Physiological Soci(cid:173)
`ety, United States, (Feb. 2009).
`Wasilewski, M.L., Academy of Aesthetic and Anti-Aging Medicine,
`Application of magnetic fields with deep stimulation in the fight
`against local obesity of lower limbs, BTL, 2012, 4 pages.
`MAG Expert, 2 pages.
`Salus Talent-Pop Double, 1 page.
`
`* cited by examiner
`
`LUMENIS EX1001
`Page 4
`
`

`

`U.S. Patent
`
`Oct. 20, 2020
`
`Sheet 1 of 8
`
`US 10,806,943 B2
`
`FIGURE 1
`
`LUMENIS EX1001
`Page 5
`
`

`

`U.S. Patent
`
`Oct. 20, 2020
`
`Sheet 2 of 8
`
`US 10,806,943 B2
`
`(22)
`
`(a)
`
`n
`
`(22)
`.,.
`
`/~ 6)
`_,,,...,,.,.
`~,.,,
`= ~,,,.
`
`.
`~ t
`
`!
`
`(10)
`
`(20)
`---(18)
`
`( b)
`
`5)
`
`FIGURE 2
`
`LUMENIS EX1001
`Page 6
`
`

`

`U.S. Patent
`
`Oct. 20, 2020
`
`Sheet 3 of 8
`
`US 10,806,943 B2
`
`-
`
`LUMENIS EX1001
`Page 7
`
`

`

`U.S. Patent
`
`Oct. 20, 2020
`
`Sheet 4 of 8
`
`US 10,806,943 B2
`
`(2)
`II
`I
`-z··•~ -.,.,.
`{' ""
`~ ~,
`
`-
`
`(P'
`
`',:, tJ'
`
`(/ (f
`
`,rJ ~·
`"' J!
`(j
`i'.l
`(
`
`(2
`
`(17)
`
`(a)
`
`( b )
`
`(3)
`
`(24)
`
`/
`
`2)
`
`/
`
`.·','-~: ..
`........... __
`-
`
`~
`
`-~.
`·-·-·
`
`(22}
`
`/
`
`FIGURE 4
`
`LUMENIS EX1001
`Page 8
`
`

`

`U.S. Patent
`
`Oct. 20, 2020
`
`Sheet 5 of 8
`
`US 10,806,943 B2
`
`)
`
`(a)
`
`(26)
`
`(b)
`
`(2)
`
`22)
`
`)
`
`(d)
`
`FIGURE 5
`
`LUMENIS EX1001
`Page 9
`
`

`

`U.S. Patent
`
`Oct. 20, 2020
`
`Sheet 6 of 8
`
`US 10,806,943 B2
`
`(2)
`
`(32)
`
`( b)
`
`(3)
`
`6)
`
`(24)
`
`'
`
`.: .. •·. »•~' •• ,
`
`"
`
`'. •
`
`'
`
`~
`~
`..... ······ ; _____ L----t ··-··-
`·-·: .. ! ) _) 1---· -
`. j.J .. 7··~=~-·:·-:
`I
`I
`.
`! ·-··1-~~i .. -·;·~ · · I
`
`!
`
`1
`
`I
`!
`;
`.
`,
`I
`'
`" "1 ' ' ' ' " " - '
`
`( a )
`
`(33)
`
`(22)
`
`2)
`
`( C )
`
`( d)
`
`FIGUHE 6
`
`LUMENIS EX1001
`Page 10
`
`

`

`U.S. Patent
`
`Oct. 20, 2020
`
`Sheet 7 of 8
`
`US 10,806,943 B2
`
`N u
`
`lJ
`
`--1
`
`>
`0
`0
`0 ....
`!
`0
`0
`I.fl
`
`0
`
`,,.
`0
`:::,
`
`LUMENIS EX1001
`Page 11
`
`

`

`U.S. Patent
`
`Oct. 20, 2020
`
`Sheet 8 of 8
`
`US 10,806,943 B2
`
`I (tJ
`
`3000A
`
`7-
`------ - - - " ' - - /j
`
`(\
`I
`\
`
`r----'l-»--~-- /( ··-- _ _,______ · ..\
`\
`
`I i j
`
`· 1 - _.,._ f
`
`I \ )
`~/
`
`-~ 300 ,US - fp-1
`1
`33 ms~ f"'d
`-
`T
`'Stim
`--
`15·10.., 6 H
`l
`Uc2 ~ l 000 V
`I (t) Time Interval r.·-t
`
`FIGURE 8
`
`LUMENIS EX1001
`Page 12
`
`

`

`US 10,806,943 B2
`
`1
`DEVICE FOR REPETITIVE NERVE
`STIMULATION IN ORDER TO BREAK
`DOWN FAT TISSUE MEANS OF INDUCTIVE
`MAGNETIC FIELDS
`
`CROSS REFERENCE TO RELATED
`APPLICATION
`
`This application is related to and claims priority from the
`German PCT Patent Application No. PCT/IB2013/001896
`filed on Jul. 2, 2013, which claims priority to German Patent
`Application No. 10 2012 013 534.3 filed on Jul. 5, 2012.
`The present invention makes use of the effect of stimu(cid:173)
`lating muscle contractions by contactless induction of elec(cid:173)
`trical fields by means of pulse-shaped magnetic fields in the
`tissue. Pulsating magnetic fields are also capable of exciting
`ion transport by influencing the electric currents and mea(cid:173)
`surably increasing metabolism. There is a demonstrable
`increase in blood circulation and an increased supply of
`oxygen. These effects are currently being medically evalu(cid:173)
`ated from the point of view of the reactivation of muscles
`after illness or accident and have already led to correspond(cid:173)
`ing inventions. Thus, from DE 10 2007 044 445 Al, a
`training device with magnetic stimulation is known wherein
`in conjunction with means for mechanically guiding an
`intended movement of a joint in a paralysed body part, this
`body part is stimulated to move. From US 2005/203332 Al,
`a device for the treatment of osteoporosis and other mus(cid:173)
`culo-skeletal diseases is known in which the patient, lying 30
`on a couch, is surrounded at the respective part of the body
`by a cylindrical coil which generates an electromagnetic
`field. From U.S. Pat. No. 6,213,933 Bl a device and a
`method for dissolving blood clots in human body parts can
`be inferred, in which the patient lies on an elongated
`platform over which a transversely extending, longitudinally
`movable holder with a water-cooled magnetic field coil of
`the butterfly type is arranged for stimulation. In order to
`position the magnetic field coil, the holder is simply pushed
`over the part of the body that is to be treated. The frequency 40
`and duration of stimulation is controlled by an interactive
`programme on a PC. Another electromagnetic system
`known from US 2003/0158585 Al uses ergonomic stimu(cid:173)
`lating coils in the form of flexible flat or cylindrical coils,
`adapted to the contour of the particular body part, for 45
`therapeutic treatment, for stimulating nerves, muscles and
`other tissues of the human body.
`Beyond this-and not previously utilised-muscle exci(cid:173)
`tation by magnetic field stimulation leads to a breakdown of
`fatty tissue in the area around the muscles, as the Applicant 50
`has demonstrated by numerous experiments, particularly on
`obese and muscular test subjects. In slender test subjects,
`there is a development of muscle with no significant weight
`loss.
`Admittedly, there were already devices and methods for
`treating obesity or excess weight by means of pulsating
`magnetic fields, but these either require, in addition to the
`field-generating coil, another permanent magnet in contact
`with the surface of the body (DE 100 62 050Al) or they act
`indirectly through a magnetic field that activates the thyroid
`(DE 10 2009 043 728 Al) and also have to be applied to the
`body by means of a neck band.
`Thus, using the experience and findings described above,
`the object of the invention is to provide a device and a
`method for repetitive nerve stimulation for breaking down 65
`fatty tissue by means of inductive magnetic fields, which
`permit easy patient-centred adjustment and control, in order
`
`2
`to reduce fatty tissue in defined regions of the body, such as
`the abdomen, buttocks or thighs, in targeted manner and
`without any body contact.
`This object is achieved by the device claimed in claim 1
`5 and the method claimed in claim 14. Advantageous embodi(cid:173)
`ments of the invention are the subject of the sub-claims.
`Advantages of the invention consist particularly in the
`contactless induction of excitation, the associated low levels
`of the pain stimulation that occurs with alternative electrical
`10 excitation, the large area of excitation and the ability to
`position the stimulation-producing coil to suit the individual
`body shape of the patient.
`Essential components of the device are a large-area mag-
`15 netic field coil through which current passes, hereinafter
`referred to as the stimulation coil, which is attached to a
`stand. Different coil shapes are provided for the treatment of
`the abdomen, buttocks and thighs.
`The stimulation coil produces magnetic fields with peaks
`at a magnetic flow density of 0.01 T to 0.1 T at about 5 cm
`in front of the surface of the coil. The magnetic field can be
`varied over time and consists of diphase or monophase
`pulses with a pulse duration T of 100 µs to 300 µs. The repeat
`frequency of the pulses (stimulation frequency fP) is 10 Hz
`to 30 Hz. Maximum electric field intensities of 0.1 V/cm to
`1 V/cm are achieved by induction at the stimulation site in
`the tissue. The magnetic field of the coil is approximately
`locally constant in magnitude throughout the volume of
`tissue to be treated. Parameters of a typical coil are shown
`in Table 1.
`
`20
`
`25
`
`TABLE 1
`
`Overview of the parameters of the coil for the abdominal area
`
`35 Variable
`
`Length of conductor
`Cross-sectional area
`Distance between adjacent coil conductors
`Maximum current amplitude I
`Max. magn. flow density B, 5 cm in
`front of the coil surface
`Induced electrical field intensity (maximum), E
`Forces between adjacent coil conductors
`Inductivity of the coil, L
`Pulse frequency, f
`Inductive resistance ZL at f
`Inductive voltage drop at I
`Ohmic resistance, R
`Stimulation frequency, fstim
`Joule's power loss, P
`
`Value
`
`200 cm
`1 cm2
`1 cm
`1000 A
`0.01 T
`
`0.1 V cm- 1
`0.2 Ncm- 1
`15 10-6 H
`5 103 Hz
`470 m Ohm
`470 V
`36 m Ohm
`30 Hz
`120 W
`
`The stimulation coil is actuated by means of a pulse
`generator (stimulator), which is installed separately from the
`stand. A stimulator of the kind currently used as a prototype
`in medical research (IMETUM, Central Institute for Medical
`Technology, Technical University of Munich, Concluding
`55 Report: "Functional peripheral magnetic stimulation of
`motor functions in patients with central paresis, particularly
`hemiplegic paralysis", 2011) with a pulse length of 160 µs
`( di phase) may be used. The capacity of a capacitor is
`matched to the inductivity of the stimulation coil in order to
`60 tune the resonating frequency of an LC resonator consisting
`of the stimulation coil and the capacitor, to the frequency
`corresponding to the pulse duration. The electric fields
`required give rise to high currents through the coil in the
`range from 500 A to 6000 A.
`The large area of the coil enables it to have an open,
`non-cast structure. As a result, the considerable Joule's heat
`produced in the coil can be removed by means of an air fan.
`
`LUMENIS EX1001
`Page 13
`
`

`

`US 10,806,943 B2
`
`5
`
`4
`treatment time, by means of a corresponding programme,
`depending on the signals received.
`An embodiment of the invention which demonstrates
`further advantages and special features is shown in FIGS. 1
`to 8 and described in more detail hereinafter.
`In the drawings:
`FIG. 1 is an overall view of the device for repetitive nerve
`stimulation for breaking down fatty issue by means of
`inductive magnetic fields.
`FIG. 2 is a detailed view of the stand/stimulation coil
`connecting arrangement in
`(a) perspective view and
`(b) sectional view.
`FIG. 3 shows the lead coupling for outgoing and return
`conductors within the stand/stimulation coil connecting
`arrangement in
`(a) sectional view and
`(b) perspective view in the coupled state.
`FIG. 4 shows a stimulation coil for treatment of the
`abdomen in
`(a) perspective view of the housing from the front (treat(cid:173)
`ment side) with the protective cover open, and
`(b) perspective view of the housing from behind (stand
`side) with the lead couplings visible.
`FIG. 5 shows a stimulation coil for treatment of the
`buttocks region in
`(a) a view of the housing from in front (treatment side)
`(b) a view of the housing from the side
`( c) a view of the housing from above
`( d) the configuration of the coil inside the housing, seen
`from the viewpoint of the treated person.
`FIG. 6 shows a stimulation coil for treatment of the thighs
`Ill
`
`20
`
`3
`Airflow is provided for effective cooling. Contamination and
`dust turbulence are prevented by filter mats.
`The treatment times range from 1 min to 45 min. The long
`times can be achieved without overheating of the coil thanks
`to the effective cooling and the coil design.
`The coil itself may, on account of its size, be produced as
`a self-supporting structure of solid metal ( e.g. copper or
`aluminium). This assists the conduction of heat away from
`the coil conductor to its surface. The cross-section of the
`conductor is 1 cm2 to about 2 cm2
`. This large cross-section 10
`of the coil conductor, by comparison with that of coils used
`in site-selective magnetic field stimulation (focussing),
`reduces the ohmic resistance, thus reducing the Joule's heat.
`Alternatively, the coil may also be produced from high(cid:173)
`frequency wires, by conventional technology, to avoid skin 15
`and proximity effects. However, an estimation of the skin
`depth shows that this is not necessary with a pulse duration
`of about 200 µs.
`In a solid construction, it may also be conceivable to use
`hollow conductors which are cooled by a coolant liquid.
`The stimulation coil is encapsulated in a plastic housing.
`The housing ensures protection from contact voltage and at
`the same time directs the coolant air.
`The fan produces a current of coolant air which reaches
`the coil through air inlet openings and air guiding elements 25
`fitted with filters which are provided in the plastic housing
`of the stimulation coil, and this coolant air is supplied to the
`air outlet openings of the fan through an air guide made of
`plastics which is arranged around the electric connecting
`leads to the coil. The fan may consequently be arranged at 30
`the back of the stand and outside the magnetic field of the
`stimulation coil, thus preventing any adverse effects on the
`electric fan motor.
`As a result of the high currents, high mechanical forces
`occur between the conductor sections of the stimulation coil 35
`and the connecting leads. These are absorbed by ceramic
`retaining elements which maintain a spacing.
`The electric connecting wires to the stimulation coil in the
`stand are of solid construction with no movable cables. This
`permits an optimum release of heat into the air, absorption 40
`of the magnetic forces and high operational reliability.
`The stimulation coil is mounted on a holder which is
`formed by the solid current supply lines themselves. This
`holder positions the coil at an adequate distance from the
`stand; the unwanted eddy currents induced in the stand by 45
`the coil are minimised in this way.
`A stimulation coil can easily be changed after opening a
`torsionally and axially mounted closure sleeve with a bayo(cid:173)
`net closure and loosening two screws for the connecting
`leads. This is significant, as different optimum coil shapes 50
`with different housings are used for different areas of the
`body (abdomen, thighs and buttocks).
`The positioning of the stimulation coil relative to the
`patient can be varied by means of a variable-height pedestal.
`Thus the connecting leads to the stimulation coil can be 55
`made rigid in design and changes in the inductivity and input
`resistance caused by changes of position can be avoided.
`Alternatively, positioning of the stimulation coil on the
`stand could be carried out by the use of clamping closures
`in vertical rails.
`The stimulation of muscle contraction can be optimised
`by means of a feedback link. For this purpose, the contrac(cid:173)
`tions triggered by a stimulation coil are observed using a
`camera integrated into the stand and corresponding signals
`are transmitted to a computer ( e.g. a laptop). This controls
`the electrical pulses located at the output of the pulse
`generator in terms of pulse form, duration, amplitude and
`
`(a) a view of the housing from in front (treatment side)
`(b) a view of the housing from the side
`( c) a view of the housing from above
`( d) the configuration of the coil inside the housing, seen
`from the viewpoint of the treated person.
`FIG. 7 is a basic circuit diagram of a bipolar pulse
`generator.
`FIG. 8 shows an idealised current flow in a stimulation
`coil with bipolar actuation by the pulse generator.
`FIG. 1 shows, in overall view, the device as claimed for
`repetitive nerve stimulation for breaking down fatty tissue
`by means of inductive magnetic fields, having a stimulation
`coil (3) replaceably attached to a stand (1) and accommo(cid:173)
`dated in a plastic housing (2), a variable-height pedestal (4)
`with a foot pump (5) for adjustable positioning to tailor it
`individually to a patient's body, a pivotable camera (6)
`integrated in the stand (1) with an adjustment ring (7), for
`observing the muscle contractions triggered and for feeding
`back to a laptop (9) integrated in an operating console (8),
`said laptop comprising control software for computer-aided
`optimisation of the stimulation, a fan (10) for cooling the
`magnetic field coil (3), a pulse generator (11) for electrically
`actuating the magnetic field coil (3), a shielded cable chan(cid:173)
`nel (12) for the necessary electrical connecting wires
`between the stand (1) and the pulse generator (11) or the
`60 operating console (8) and a spotlight (13) for correctly
`illuminating the area of the body captured by the camera (6).
`It should