(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2016/0184601 A1
`Gleich et al.
`(43) Pub. Date:
`Jun. 30, 2016
`
`US 2016O1846O1A1
`
`(54) MAGNETICSTIMULATOR FOR
`STMULATING TISSUE WITH A MAGNETIC
`FIELD
`
`(30)
`
`Foreign Application Priority Data
`
`Jun. 21, 2013 (DE) ...................... 10 2013 21 1859.7
`
`(71) Applicant: TECHNISCHE UNIVERSITAT
`MUNCHEN, München (DE)
`
`(72) Inventors: Bernhard Gleich, Odelzhausen, OT
`Sittenbach (DE); Nikolai Jung,
`Muenchen (DE); Volker Mall,
`Muenchen (DE); Norbert Gattinger,
`Olching (DE)
`
`(21) Appl. No.:
`
`14/899,950
`
`(22) PCT Filed:
`
`Jun. 20, 2014
`
`S371 (c)(1),
`(2) Date:
`
`Dec. 18, 2015
`
`
`
`Publication Classificati
`DCOSSO
`
`(51) Int. Cl.
`A6N2/02
`(52) U.S. Cl.
`CPC ........................................ A61N 2/02 (2013.01)
`
`(2006.01)
`
`ABSTRACT
`(57)
`A magnetic stimulator for stimulation of a tissue by a mag
`netic field, having a pulse generator device which comprises
`a pulse capacitor which can be charged by a charging circuit
`in order to generate a pulse sequence consisting of pulses and
`having an adjustable repeat rate; and having a programmable
`control device which adjusts the pulse generator device to
`generate a complex pulse sequence, which comprises indi
`vidually configurable pulses, wherein the generated complex
`pulse sequence is applied to a stimulation coil in order to
`generate the magnetic field.
`
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`MAGNETC STIMULATOR FOR
`STIMULATING TISSUE WITH A MAGNETIC
`FIELD
`0001. The magnetic stimulation can be used for non-inva
`sive investigation and stimulation of tissue, in particular
`organic tissue. In conjunction with this, an alternating mag
`netic field is generated by means of a brief flow of current
`through a coil. Transcranial magnetic stimulation (TMS) is
`used to stimulate e.g. the human brain by means of the applied
`alternating magnetic field. By means of the stimulation of e.g.
`motor areas of the brain, motor evoked potentials (MEPs) in
`muscle tissue can be deduced, the properties of which and
`changes in which allow conclusions to be drawn as to the
`excitability of the areas of the brain under investigation. TMS
`is principally of significance in the induction and evaluation
`of cortical plasticity. Cortical plasticity relates to the brains
`ability to adapt to changed conditions. Furthermore, repeti
`tive stimulation by means of a pulsed magnetic field can be
`used during treatment of different conditions, in particular
`depression. In order to evaluate the corticospinal system,
`transcranial magnetic stimulation is regularly used for neu
`rological diagnosis owing to its high level of sensitivity and
`relatively simple implementation. By application of stimula
`tion protocols for transcranial magnetic stimulation, the func
`tion of neuronal networks can be both influenced and evalu
`ated.
`0002. By means of the alternating magnetic field gener
`ated by a stimulation coil, motor neurons of the tissue can be
`excited to a motor evoked potential and to an accompanying
`muscle response. This motor evoked potential can be deduced
`and evaluated. The induced field used for stimulation is gen
`erated by means of a pulsed magnetic field, wherein this can
`be applied to the patient in a contact-free manner and causes
`no pain whatsoever at that location.
`0003 Conventional magnetic stimulators use an oscillat
`ing circuit to generate the alternating magnetic field. This
`oscillating circuit comprises a pulse capacitor and a stimula
`tion coil. FIG. 1 shows a conventional magnetic stimulator as
`described in DE 10 2006 024 467 A1. This magnetic stimu
`lator contains an oscillation circuit with a pulse capacitor C
`and a stimulation coil to generate a magnetic field. A charging
`circuit is provided to charge the pulse capacitor C. Further
`more, the conventional magnetic stimulator in FIG. 1 con
`tains a controllable switch to break and close the oscillation
`circuit. A control circuit opens and closes the controllable
`Switch Such that by means of the oscillation circuit a stimu
`lation pulse with an adjustable number of half or full waves
`can be generated. The controllable switch can be, for
`example, a thyristor or an IGBT. With the aid of the control
`lable switch, integer multiples of full waves can be applied.
`Prior to pulse triggering, the pulse capacitor is charged to a
`desired Voltage. The energy content of the pulse capacitor sets
`the current strength through the stimulation coil and therefore
`the pulse intensity (pulse strength) of the pulse to be output. If
`the switch is closed, a current begins to flow through the
`stimulation coil and the pulse capacitor begins to discharge.
`After the coil current abates, all of the pulse energy is con
`Sumed and the pulse capacitor is fully discharged. The pulse
`capacitor must then be charged to the desired Voltage level
`prior to the next pulse. However, Such conventional magnetic
`stimulators have the disadvantage that the number of pulses
`generated by the pulse generator device is time-limited. In
`conventional magnetic stimulators, the maximum repeat rate,
`i.e. the number of pulses output per unit of time, is 100 pulses
`
`per second. A further Substantial disadvantage of conven
`tional magnetic stimulators is that they can generate only
`sinusoidal pulses. Conventional magnetic stimulators gener
`ally generate monophase and biphase pulses with adjustable
`pulse width. Furthermore, with conventional magnetic stimu
`lators only pulse sequences which contain pulses of the same
`pulse form can be generated. An individual configuration of
`the pulses with respect to their pulse form and/or pulse polar
`ity in order to create complex pulse sequences is not possible.
`Individual or flexible adaptation of the generated pulse
`sequence to the tissue to be investigated or a clinical picture
`thus cannot be effected with conventional magnetic stimula
`tOrS.
`0004. It is therefore an object of the present invention to
`create a magnetic stimulator for stimulation of a tissue by a
`magnetic field, in which the above-mentioned disadvantages
`are avoided and in which pulse sequences can be adapted
`flexibly to the tissue to be investigated or to a clinical picture
`of a patient.
`0005. In accordance with the invention, this object is
`achieved by a magnetic stimulator having the features stated
`in claim 1.
`0006. The invention accordingly creates a magnetic stimu
`lator for stimulation of a tissue by a magnetic field with a
`pulse generator device which has a pulse capacitor which can
`be charged by a charging circuit in order to generate a pulse
`sequence consisting of pulses and having a repeat rate which
`can be adjusted and having a programmable control device
`which adjusts the pulse generator device in order to generate
`a complex pulse sequence which has individually config
`urable pulses, wherein the generated complex pulse sequence
`is applied to a stimulation coil in order to generate the mag
`netic field.
`0007. The magnetic stimulator in accordance with the
`invention makes it possible to generate complex pulse
`sequences and pulse patterns at a high adjustable repeat rate
`and to provide a stimulation coil connected to the magnetic
`stimulator in order to generate the alternating magnetic field.
`In this way, reproducible and effective changes in plasticity
`can be achieved in a stimulated brain.
`0008. In one possible embodiment of the magnetic stimu
`lator in accordance with the invention, the pulse sequence
`output by the pulse generator device is a simple pulse
`sequence consisting of pulses or is a complex pulse sequence.
`0009. The generated complex pulse frequency preferably
`has pulse trains which each comprise pulse packets which
`each consist of a series of pulses, wherein a pulse form and/or
`polarity of the pulses is/are individually configurable.
`0010. In a further possible embodiment of the magnetic
`stimulator in accordance with the invention, the program
`mable control device of the magnetic stimulator can be con
`nected to a computer via an interface, on which computer a
`user-editor is provided to configure the pulse sequence.
`0011. In a further possible embodiment of the magnetic
`stimulator inaccordance with the invention, the user-editor of
`the computer connected to the magnetic stimulator has a
`stimulus designer to configure a pulse form of the respective
`pulses of the pulse sequence.
`0012. In a further possible embodiment, the user-editor
`further comprises a pulse packet assistant to configure at least
`one pulse packet consisting of pulses.
`0013. In a further possible embodiment, the user-editor
`additionally comprises a pulse train assistant to configure at
`least one pulse train consisting of pulse packets.
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`0014. In a further possible embodiment of the magnetic
`stimulator in accordance with the invention, the complex
`pulse sequence configured by means of the user-editor is
`transmitted via the interface to the programmable control
`device of the magnetic stimulator and is stored in a memory
`unit of the magnetic stimulator.
`0015. In a further possible embodiment of the magnetic
`stimulator in accordance with the invention, the repeat rate of
`the pulse sequence, which indicates the number of pulses
`output per second, can be adjusted within a range of 0 to 1
`kHZ.
`0016. In a further possible embodiment of the magnetic
`stimulator in accordance with the invention, an evaluation
`pulse for measuring a motor muscular response of the stimu
`lated tissue is output between pulse packets of the complex
`pulse sequence which is generated by the pulse generator
`device of the magnetic stimulator.
`0017. In a further possible embodiment of the magnetic
`stimulator in accordance with the invention, the pulse gen
`erator device of the magnetic stimulator has an oscillation
`circuit, which contains the pulse capacitor and the stimulation
`coil, and at least one power Switch which is connected to a
`driver circuit which can be controlled by the programmable
`control device of the magnetic stimulator.
`0018. In one possible embodiment of the magnetic stimu
`lator in accordance with the invention, the stimulation coil is
`in a full bridge circuit connection with four power switches to
`generate pulses, the pulse form of which can be composed of
`pulse segments.
`0019. In a further possible embodiment of the magnetic
`stimulator in accordance with the invention, the pulse gen
`erator device of the magnetic stimulator has a charging circuit
`for recharging the pulse capacitor with the adjusted repeat
`rate.
`0020. In one possible embodiment of the magnetic stimu
`lator in accordance with the invention, the charging circuit of
`the pulse generator device is a linear charging circuit.
`0021. In one possible embodiment, this linear charging
`circuit has a mains adapter for connection to a power Supply
`network, an intermediate energy circuit for intermediate Stor
`age of the electrical energy Supplied by the mains adapter, and
`a charge regulator which is connected to the oscillation circuit
`of the pulse generator device.
`0022. In a further possible alternative embodiment of the
`magnetic stimulator in accordance with the invention, the
`charging circuit of the pulse generator device has a clocked
`charging circuit.
`0023. In one possible embodiment of the clocked charging
`circuit, this charging circuit has a mains adapter for connec
`tion to a power Supply network,
`0024 a first DC/DC switching regulator for continuous
`operation,
`0025 an intermediate energy circuit for intermediate stor
`age of the electrical energy supplied from the first DC/DC
`Switching regulator and
`0026 a second DC/DC switching regulator for pulsed
`operation, which is connected to the oscillation circuit of the
`pulse generator device.
`0027. In a further possible embodiment of the magnetic
`stimulator in accordance with the invention, the pulse gen
`erator device has a coil monitoring circuit.
`0028. In one possible embodiment of the coil monitoring
`circuit, this coil monitoring circuit monitors whether a stimu
`lation coil is connected to the magnetic stimulator.
`
`0029. In a further possible embodiment of the magnetic
`stimulator in accordance with the invention, the coil monitor
`ing circuit has sensors to monitor operating parameters of the
`stimulation coil, in particular the operating temperature
`thereof.
`0030. In a further possible embodiment of the magnetic
`stimulator in accordance with the invention, the program
`mable control device causes the pulse generator device to
`output the pulse sequence to the stimulation coil only after a
`system check of parameters of the magnetic stimulator has
`been Successfully concluded.
`0031. In a further possible embodiment of the magnetic
`stimulator in accordance with the invention, the program
`mable control device can be connected to a conducting elec
`trode which is attached to the tissue to be stimulated, in order
`to conduct a measurement signal and/or to generate a trigger
`signal.
`0032. In a further possible embodiment of the magnetic
`stimulator in accordance with the invention, the measurement
`signal conducted through the conducting electrode is evalu
`ated by the programmable control device in order to deter
`mine a motor threshold.
`0033. The invention further provides a method for gener
`ating a magnetic field having the features stated in claim 17.
`0034. According to a further aspect a method for generat
`ing a magnetic field is provided having the following steps:
`0035 generating a complex pulse sequence which con
`sists of individually configured pulses with a variable pulse
`form, by means of a pulse generator device,
`0036 applying the generated pulse sequence with an
`adjustable repeat rate to a stimulation coil which generates
`the magnetic field therefrom and
`0037 recharging a pulse capacitor of the pulse generator
`device by a charging circuit with the adjusted repeat rate.
`0038. In one possible embodiment of the method the
`repeat rate, which indicates the number of pulses per unit of
`time, is adjusted in a range of 0 to 1 kHz.
`0039. In one possible embodiment of the method the gen
`erated complex pulse sequence comprises pulse trains which
`each comprise pulse packets which each consist of a series of
`pulses, the pulse form and/or polarity of which is/are indi
`vidually configured.
`0040. According to a further aspect a device for use in a
`method for stimulating a tissue by a magnetic field is pro
`vided,
`0041 wherein a complex pulse sequence, which consists
`of individually configured pulses with a variable pulse form,
`is generated by a pulse generator device,
`0042 wherein the generated pulse sequence is applied
`with an adjustable repeat rate to a stimulation coil which
`generates the magnetic field therefrom,
`0043 wherein a pulse capacitor of the pulse generator
`device is recharged by a charging circuit with the adjusted
`repeat rate.
`0044 Possible embodiments of the magnetic stimulator in
`accordance with the invention for stimulation of a tissue by a
`magnetic field are explained in more detail hereinunder with
`reference to the attached figures, in which:
`0045 FIG. 1 is a block circuit diagram of a conventional
`magnetic stimulator in accordance with the prior art;
`0046 FIG. 2 is a block circuit diagram to illustrate a pos
`sible embodiment of a magnetic stimulator in accordance
`with the invention for stimulation of a tissue by a magnetic
`field;
`
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`US 2016/0184601 A1
`
`Jun. 30, 2016
`
`0047 FIG.3 is a further block circuit diagram to illustrate
`an exemplified embodiment of the magnetic stimulator in
`accordance with the invention;
`0048 FIG. 4 is a diagram to explain a system check carried
`out by the control device in the magnetic stimulator in accor
`dance with the invention;
`0049 FIG.5 is a block circuit diagram for illustration of an
`exemplified embodiment of a driver circuit used in a pulse
`generator device of the magnetic stimulator in accordance
`with the invention;
`0050 FIG. 6 shows signal diagrams for explanation of
`current Zero crossing identification which is used in the driver
`circuit used in FIG. 5:
`0051
`FIG. 7 is a circuit diagram to illustrate an exempli
`fied embodiment of a pulse generator device in which the
`stimulation coil is in a full bridge circuit connection;
`0052 FIG. 8 shows diagrams for explanation of the mode
`of operation of the full bridge circuit shown in FIG. 7 for
`generation of pulses from pulse segments;
`0053 FIG. 9 is a signal diagram for explanation of the
`actuation of the full bridge circuit shown in FIG. 7 with
`alternating polarities;
`0054 FIG. 10 is a signal diagram for explanation of the
`actuation of the full bridge circuit shown in FIG. 7 with an
`individual polarity;
`0055 FIG. 11 is a signal diagram for illustration of actua
`tion of the full bridge circuit shown in FIG. 7 with holding
`phases;
`0056 FIG. 12 shows a possible embodiment of a full
`bridge circuit with Switched capacitances;
`0057 FIG. 13 is a signal diagram for illustration of an
`exemplified asymmetric pulse form;
`0058 FIG. 14 is a block circuit diagram for illustration of
`an exemplified embodiment of a charging circuit used within
`the pulse generator device of the magnetic stimulator,
`0059 FIG. 15 is a charging curve for explanation of the
`mode of operation of the intermediate energy circuit used
`within the charging circuit;
`0060 FIG. 16 is a signal diagram for illustration of the
`Voltage progression on a pulse capacitor and for actuation of
`charging Switches of the charging regulation provided within
`the charging circuit and illustrated in FIG. 14;
`0061
`FIG. 17 is a block circuit diagram of a clocked
`charging circuit used within the pulse generator device of the
`magnetic stimulator in accordance with the invention;
`0062 FIG. 18 shows a current progression for explanation
`of the mode of operation of a particular embodiment of the
`clocked charging circuit illustrated in FIG. 17:
`0063 FIG. 19 is a circuit diagram for illustration of an
`embodiment of a powerform correction circuit as an upwards
`converter;
`0064 FIG. 20 is a circuit diagram for illustration of an
`embodiment variation of the charging regulator used in the
`clocked charging circuit,
`0065 FIG. 21 is a diagram for illustration of a charging
`current of a pulse capacitor of the embodiment variation of
`the charging regulator shown in FIG. 20;
`0066 FIG. 22 is a circuit diagram for illustration of a
`further embodiment variation of the charging regulator which
`can be used in the clocked charging circuit in accordance with
`FIG. 17:
`0067 FIG. 23 is a diagram for illustration of the current
`flow in the variation of a charging regulator shown in FIG.22;
`
`0068 FIG. 24 is a circuit diagram for illustration of a
`further embodiment variation of a charging regulator as can
`be used in the clocked charging circuit in accordance with
`FIG. 17:
`0069 FIG.25 is a diagram to illustrate a working sequence
`for configuration of pulse forms of a complex pulse sequence
`used in the magnetic stimulator in accordance with the inven
`tion;
`(0070 FIGS. 26, 27 and 28 are diagrams to illustrate the
`pulse variants which can be achieved and which can be con
`tained in a complex pulse sequence of the magnetic stimulator
`in accordance with the invention;
`0071 FIG.29 is a diagram for illustration of a pulse packet
`within a complex pulse sequence, wherein the pulse packet
`consists of a preset number of pulses;
`0072 FIG. 30 is a signal diagram for illustration of a
`plurality of pulse packets which are each composed of indi
`vidual pulses;
`0073 FIG.31 is a signal diagram to illustrate a single wave
`as can be contained within a complex pulse sequence of the
`magnetic stimulator,
`0074 FIG. 32 is a signal diagram to illustrate a double
`wave as can be contained within a complex pulse sequence of
`the magnetic stimulator in accordance with the invention;
`0075 FIG. 33 is a diagram to illustrate a complete com
`plex pulse sequence with a plurality of pulse trains which
`each consist of pulse packets which are for their part com
`posed of configurable pulses as can be output to a stimulation
`coil by the magnetic stimulator in accordance with the inven
`tion;
`0076 FIG. 34 is a signal diagram to illustrate a complex
`pulse sequence with an evaluation pulse contained thereinfor
`explanation of an embodiment variation of the magnetic
`stimulator in accordance with the invention;
`0077 FIG.35 is a diagram for explanation of the operating
`sequence of one possible embodiment variation of the mag
`netic stimulator in accordance with the invention;
`0078 FIG. 36 is a diagram for explanation of an embodi
`ment variation of the user-editor used in the magnetic stimu
`lator in accordance with the invention, having a stimulus
`designer;
`007.9 FIG.37 is an illustration of the pulse packet assistant
`used in the user-editor;
`0080 FIG.38 is a diagram to illustrate a pulse train assis
`tant used in the user-editor,
`I0081
`FIG. 39 is a diagram to illustrate a stimulus designer
`used in the user-editor;
`I0082 FIGS. 40A, 40B are diagrams to illustrate a pulse
`packet and pulse train assistant which are used in the user
`editor;
`I0083 FIG. 41 is a diagram to illustrate a pulse selector
`used in one possible embodiment variation;
`I0084 FIG. 42 shows an example of a pulse composed
`using a user-editor;
`I0085 FIG. 43 is a diagram to illustrate a standardised
`muscle potential as can be caused by the magnetic stimulator
`in accordance with the invention in comparison with a con
`ventional magnetic stimulator,
`I0086
`FIG. 44 is a diagram to illustrate a standardised
`muscle potential as can be caused by the magnetic stimulator
`in accordance with the invention for different current flow
`directions;
`
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`

`US 2016/0184601 A1
`
`Jun. 30, 2016
`
`0087 FIG. 45 is a further diagram to illustrate a standar
`dised muscle potential as can be caused by the magnetic
`stimulator in accordance with the invention when using a
`doubled sine wave;
`0088 FIG. 46 shows diagrams to illustrate a motor thresh
`old in dependence upon a current flow direction used in the
`magnetic stimulator in accordance with the invention.
`0089 FIG. 2 shows an exemplified embodiment of a mag
`netic stimulator 1 in accordance with the invention for stimu
`lation of a tissue by a magnetic field. The tissue can be e.g.
`organic tissue of a patient P, especially brain tissue. In the
`illustrated embodiment, the magnetic stimulator 1 has a pulse
`generator device 2 and a programmable controller 3. The
`pulse generator device 2 contains at least one pulse capacitor
`which can be charged by a charging circuit to generate a pulse
`sequence, consisting of pulses, with an adjustable repeat rate.
`The control device 3 is a programmable control device which
`adjusts and/or actuates the pulse generator device Z in order
`to generate a complex pulse sequence PS. This complex pulse
`sequence can comprise individually configurable pulses. The
`complex pulse sequence PS generated by the pulse generator
`device 2 is output to a processing coil or stimulation coil 4 via
`a line 5. The line 5 can be a high voltage-carrying line or a
`high current-carrying line. The treatment or stimulation coil 4
`is located in the vicinity of the tissue to be stimulated, e.g. the
`brain tissue of a patient P, as indicated in FIG. 2. In the
`exemplified embodiment illustrated in FIG. 2, the program
`mable control device 3 of the magnetic stimulator 1 is con
`nected to a computer 7 via an interface 6.
`0090. A user-editor for configuration of a complex pulse
`sequence is preferably provided in the computer 7. The com
`puter 7 can be a PC, a tablet computer or a laptop computer,
`the user-editor of which can be used to generate or configure
`the complex pulse sequence PS. In one possible embodiment
`variation, the user-editor can be displayed to a user, who is
`treating e.g. the patient P. via a graphical user interface, GUI.
`In one possible embodiment variation, the user-editor has a
`stimulus designer for configuration of a pulse form of indi
`vidual pulses. Furthermore, the user-editor used can comprise
`a pulse packet assistant for configuration of at least one pulse
`packet consisting of pulses. Furthermore, the user-editor can
`also comprise a pulse train assistant for configuration of at
`least one pulse train consisting of pulse packets. In this way,
`it is possible for a user to configure and/or program a complex
`pulse sequence PS tailored to the individual requirements of
`the patient P. Thus, the complex pulse sequence PS consists of
`pulse trains PZ which each comprise pulse packets PP which
`for their part consist of a sequence of pulses. The pulse form
`of the pulses or individual pulses are preferably individually
`configurable with respect to their pulse form and/or polarity
`with the aid of the user-editor. In a further possible embodi
`ment, the pulse sequence PS configured by means of the
`user-editor is transmitted via the interface 6 to the pro