S/N 15/473,390
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`Attorney Dkt. No. 066964—8046.USOO
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`AMENDMENTS TO THE SPECIFICATION
`
`Please amend the Specification as follows:
`
`[00103] The application may be contact or in the preferred application the treatment
`
`may be applied contactless. Contactless application may avoid all biocompatibility
`
`factors which may occur during contact treatment.
`
`In the most preferred application
`
`the treatment may be provided by self—operated device. Hence the continual
`
`surveillance and/or control by the operator may not be essential for correct and/or
`
`safe operation of the treatment device. Self-operated treatment may be provided by a
`
`hand-held applicator or the applicator may be fixed to stand-alone device. The self-
`
`operated treatment may be also enabled using various types of sensors in
`
`communication with the device for monitoring the treatment and/or the patient. The at
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`least one sensor may be e.g. reactive sensor, electrochemical sensor, biosensor,
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`biochemical sensor, temperature sensor, sorption sensor, pH sensor, voltage sensor,
`
`sensor for measuring distance of applicator from the patient surface and/or from the
`
`treated area, position sensor, motion detector, photo sensor, camera, sound detector,
`
`current sensor, sensor for measuring of specific human/animal tissue and/or any
`
`suitable sensors measuring biological parameters and/or combination thereof such
`
`as sensor for measuring dermal tensile forces, sensor for measuring the activity of
`
`In the
`
`the muscle, muscle contraction forces,
`
`tissue impedance or skin elasticity.
`
`most preferred application the treatment may be provided by self-operated device
`
`protecting the patient and/or the magnetic stimulation device from an unintended
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`event, e.g. heat damage of the patient and/or the magnetic stimulation device.
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`S/N 15/473,390
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`Attorney Dkt. No. 066964—8046.USOO
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`Please add the following new paragraphs into the Specification:
`
`[0015.1] The coil of the magnetic stimulation device may be flexibly attached to
`
`casing of the device. The blower or blowers may be arranged to blow air on both
`
`sides of coil. Optionally, the coil may be a flat type coil.
`
`[0037.1]
`
`Power
`
`losses and/or heat generation may be monitored and/or
`
`determined by the magnetic stimulation device based on determining the waveform
`
`of any operation parameter, e.g. voltage, electric current or magnetic flux density.
`
`The determined waveform is related with a reference and/or with the operation
`
`parameter measured in a different value of a characteristic quantity, e.g.
`
`time,
`
`frequency, amplitude or phase.
`
`[0051.1] According to the invention a current value of an operation parameter, e.g.
`
`voltage, electric current or magnetic flux density, may be determined by measuring
`
`via a suitable sensor or by deriving from a value of voltage source, e.g. an energy
`
`storage device or power source. The currently determined operation parameter is
`
`processed by a mathematic and/or signal processing method.
`
`[0051.2] According to one application of the invention the at
`
`least one currently
`
`determined operation parameter may be used for determining a correctness of the
`
`stimulation. The correctness of the stimulation may be determined by the relation
`
`between a current value of an operation parameter and a reference or the operation
`
`parameter measured in a different value of characteristic quantity. The relation is
`
`result of a mathematic and/or signal processing method.
`
`[0051.3] According to one aspect of the application a calibration curve may be
`
`established. The calibration curve is calibration waveform of the operation parameter.
`
`The calibration curve may be implemented by the manufacturer as a factory setting.
`
`Alternatively, the calibration curve may be established by a mathematic and/or signal
`
`processing method. The calibration curve may be determined from at
`
`least one
`
`waveform, more preferably at least 2 waveforms, even more preferably at least 5
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`S/N 15/473,390
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`Attorney Dkt. No. 066964—8046.USOO
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`waveforms, even more preferably 10 waveforms, most preferably at
`
`least 50
`
`waveforms. The reference may be established by the complete calibration curve, a
`
`representative segment of the calibration curve or by predefined reference points of
`
`the calibration curve, e.g. a look-up-table.
`
`[0051.4] Fig. 7 illustrates a voltage calibration curve 31 of one impulse measured in
`
`the time domain. The voltage waveform may be determined e.g. on an energy
`
`storage device. However any operation parameter may be used for establishing the
`
`calibration curve.
`
`[0051.5] The currently measured voltage waveform and the calibration curve are
`
`related using a mathematic and/or signal processing method. Based on the relation
`
`at
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`least one threshold may be established. The at
`
`least one threshold may
`
`correspond to the correctness of
`
`the stimulation and/or notify operator of
`
`the
`
`magnetic stimulation device about an unintended event. The unintended event may
`
`refer to detection of a metal object e.g. metal jewelry such as ring or bracelet, or a
`
`prosthetic device such as an endoprosthesis or surgical nail within the proximity of
`
`the magnetic stimulation device; or to detection of a hardware error of the magnetic
`
`stimulation device, e.g. error of the switching device such as a thyristor. Based on the
`
`evaluation of any unintended event
`
`the treatment may be disabled and/or the
`
`notification for the operator may be generated by the magnetic stimulation device in a
`
`human perceptible form, e.g. by mechanical and/or electromagnetic means, such as
`
`audibly perceptible notification (e.g. beep) or visually perceptible notification (flashing
`
`light, color change etc.).
`
`[0051.6] In an exemplary application of the aspect of the application, the relation
`
`between currently measured voltage waveform and the voltage calibration curve may
`
`be determined by a statistic method resulting in a correlation coefficient. The time
`
`duration of the correlated calibration curve and the voltage waveform may be longer
`
`than the time duration sufficient to reach the value of a second maximum. The correct
`
`stimulation may be determined if the correlation coefficient value is in absolute value
`
`at
`
`least 0.9, more preferably at
`
`least 0.95, most preferably at
`
`least 0.99. The
`
`unintended event may be detected if the correlation coefficient value is in absolute
`
`value at least 0.4, more preferably at least 0.6, even more preferably at least 0.7,
`
`most preferably at least 0.9. The value of correlation coefficient may be used for
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`S/N 15/473,390
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`Attorney Dkt. No. 066964—8046.USOO
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`detection of a metal object within the proximity of the magnetic stimulation device e.g.
`
`metal
`
`jewelry such as a ring or bracelet, or a prosthetic device such as an
`
`endoprosthesis or a surgical nail; or for detection of hardware error of the magnetic
`
`stimulation device, e.g. error of a switching device such as thyristor.
`
`[0051.7] Fig. 8A illustrates the case when the metal object is within proximity of the
`
`magnetic stimulation device. There are two curves which refer to a voltage calibration
`
`curve 31 and the currently measured voltage waveform 32. The currently measured
`
`voltage waveform 32 differs in the value of second maximum 33 compared to the
`
`value of second maximum 34 of the voltage calibration curve 1. Further additional
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`difference occurs in time shift 35 referring to the time when the currently measured
`
`voltage reaches the value of second maximum 33 compared to the time when the
`
`calibration curve reaches the value of second maximum 34. Therefore the correlation
`
`coefficient may reach lower values in absolute values than in the case of correct
`
`stimulation when the value of the correlation coefficient in absolute value is at least
`
`0.9, more preferably at least 0.95, most preferably at least 0.99. The detection of a
`
`metal object is very important for the patient’s safety due to risk of injury caused to
`
`the patient by heat induction in the metal object and/or by the unintended movement
`
`of the metal object.
`
`[0051.8] Fig. 9 illustrates the case when a hardware error occurs, e.g. a failure of the
`
`switching device. There are two curves which refer to a voltage calibration curve 31
`
`and the currently measured voltage waveform 32. The voltage calibration curve 31
`
`value remains constant after reaching the value of second maximum 34. However,
`
`the currently measured voltage waveform 32 continues in resonance 39 although the
`
`value of second maximum 33 equals to the value of second maximum 34 of the
`
`calibration curve 31.
`
`[0051.9]
`
`In the preferred application the relation between the voltage calibration
`
`curve 31 and the currently measured voltage waveform 32 may be determined by a
`
`time period longer than time duration sufficient
`
`to reach the value of second
`
`maximum of the operation parameter.
`
`[0051.10] The calibration curve may be set by the manufacturer or by a mathematic
`
`and/or signal processing method. The magnetic stimulation device may verify and/or
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`S/N 15/473,390
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`Attorney Dkt. No. 066964—8046.USOO
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`adjust the calibration values periodically after a predetermined time period and/or
`
`after changing any part of the magnetic stimulation device.
`
`The benefit of using the correlation coefficient is that the method is independent of
`
`repetition rate and/or amplitude of the stimulation. The method also provides very
`
`precise and/or relevant results.
`
`[0051.11] In an alternative aspect of the application, the correctness of the treatment
`
`may be determined simply by a relation of the at least one specific value of the
`
`currently measured voltage waveform 32 influenced by the metal object. The metal
`
`object may absorb a part of
`
`the stimulation energy.
`
`Therefore the currently
`
`measured voltage is lower than the calibration value and the currently determined
`
`voltage drop 36 is increased as is illustrated in Fig. 8A. The value of first maximum
`
`37 corresponds with the maximum stimulation voltage generated by a voltage source,
`
`it may be simply determined from the voltage source. During the correct treatment
`
`based on energy losses a recharge of the energy storage device is not up to the
`
`value of first maximum 37 but only up to the value of second maximum 34 which is
`
`less than the value of first maximum 37. Therefore a correct voltage drop 38 occurs
`
`which is determined by the difference of the value of first maximum 37 and the value
`
`of second maximum 34. The correct voltage drop 38 corresponds with the value of
`
`first maximum 37. The voltage drop occurs within each impulse. Therefore a
`
`threshold of correct voltage drop may be set up.
`
`In the case of no unintended event
`
`and the correct treatment, the value of currently measured voltage corresponds with
`
`the calibration value and the correct voltage drop 38 remains constant during the
`
`constant operation parameters and/or ambient conditions. With respect to correct
`
`voltage drop 38 a predetermined voltage drop threshold may be set up which
`
`corresponds with the correct magnetic stimulation and which may be considered as
`
`being correct. The correct values may be calibrated by the manufacturer or may be
`
`determined by mathematic and/or signal processing methods.
`
`The magnetic
`
`stimulation device may verify and/or adjust the calibration values periodically after a
`
`predetermined time period and/or after changing any part of the magnetic stimulation
`
`device.
`
`[0051.12] The correct voltage drop threshold may be established at 30 %, more
`
`preferably 21 %, even more preferably 14 %, most preferably 7 % of the value of first
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`S/N 15/473,390
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`Attorney Dkt. No. 066964—8046.USOO
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`voltage maximum.
`
`If the voltage drop reaches the threshold then the proximity of the
`
`metal object may be determined. If the voltage drop varies in time after reaching the
`
`value of second maximum then a hardware error may be detected. The notification
`
`relating to an unintended event may be generated in human perceptible form.
`
`[0051.13] In an alternative approach, the correctness of the treatment may be also
`
`determined only by the relation values of second voltage maximums 33, 34 and/or by
`
`the relation of any other reference points in voltage calibration curve 31 and the
`
`currently measured voltage waveform 32. The reference points and/or threshold may
`
`be established by the manufacturer as factory settings, e.g. a look—up—table, or the
`
`reference points and/or threshold may be established by the operator.
`
`[0051.14] During the treatment several cases may occur.
`
`In
`
`the exemplary
`
`application the operation parameter may be voltage. These cases are:
`
`[0051.15]
`
`1)
`
`The correct stimulation case where the currently measured
`
`voltage (a specific value or a waveform) is identical or within an acceptable range of
`
`a reference or the voltage value measured in different
`
`time of the same pulse
`
`(correlation coefficient equals almost 1).
`
`[0051.16]
`
`2)
`
`The incorrect stimulation case, which may be determined by the
`
`relation of:
`
`[0051.17]
`
`a)
`
`The currently measured voltage waveform and the calibration
`
`curve; or
`
`[0051.18]
`
`b)
`
`The currently measured value of voltage measured at a
`
`predetermined time t and the predetermined correct value of voltage at time t. (e.g.
`
`the time 1‘ may be the moment of reaching the second maximum).
`
`If the relation
`
`exceeds a predefined threshold then an incorrect stimulation case is present and the
`
`magnetic stimulation device generates a notification to the personnel.
`
`[0051.19]
`
`c)
`
`The currently generated voltage is measured in two different
`
`times: time t and time t+x and the currently measured values of voltage are related
`
`together.
`
`If the relation exceeds a predefined threshold then an unintended event is
`
`present and the magnetic stimulation device generates a notification to the
`
`personnel.
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`S/N 15/473,390
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`Attorney Dkt. No. 066964—8046.USOO
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`[0051.20] As shown in Fig. SB, the correctness of the stimulation may be determined
`
`by at least one reference point in the currently measured voltage waveform.
`
`In the
`
`preferred application the value of second maximum is used because it is well defined
`
`and it may be easily determined.
`
`On the other side,
`
`the correctness of the
`
`stimulation may be determined by the relation of at least two reference points. One
`
`exemplary application may determine a voltage difference AU = U2 - U1 at time to.
`
`Based on the value of the voltage difference proximity of metal object may be
`
`determined.
`
`In this exemplary application U2 is constant because it is derived from a
`
`calibration value. Another exemplary application may determine a time difference At
`
`= t2 — t1 from when a calibration value and the measured voltage reach a selected
`
`voltage Uc. Then based on the value of the time difference proximity of metal object
`
`may be determined.
`
`In this exemplary application t1 is constant because it is derived
`
`from a calibration value.
`
`[0051.21] Fig. 8C shows determining an incorrect stimulation by currently measured
`
`values of voltage (UH, U12) measured in predetermined values of time (t1,
`
`t2). The
`
`correctness of the stimulation may be determined by the relation of U|1(t1) and U|2(t2).
`
`If the relation exceeds a predefined threshold then an unintended event is present
`
`and the magnetic stimulation device generates a notification to the personnel.
`
`In the
`
`preferred application the values of first and second maximum may be used..
`
`[0051.22] In one aspect, a method of controlling a magnetic stimulation device for
`
`treating a biological structure by time-varying magnetic field includes determining at
`
`least one value, for example (Volts), of an operation parameter (Voltage) in at least
`
`one value (microseconds) of characteristic quantity (time), wherein the value of
`
`operation parameter is related to at least one of: a calibration curve; a calibration
`
`value; or at least one value (two voltage measurements at specific times) of the
`
`same operation parameter
`
`in a different value (microseconds) of
`
`the same
`
`characteristic quantity (time), wherein the calibration curve and/or the calibration
`
`value may be determined in the same value (microseconds) or in a different value
`
`(microseconds) of the same characteristic quantity (time). The calibration curve is
`
`plurality of calibration values (Volts in this example) of an operation parameter
`
`(Voltage) in a plurality of values (microseconds) of a characteristic quantity (time). A
`
`calibration value, in this example, is a specified voltage at a specified time.
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`S/N 15/473,390
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`Attorney Dkt. No. 066964—8046.USOO
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`[0051.23] In Figs. 8D—8G, all currently measured values are shown as a circle with
`
`reference numbers marked with an apostrophe; all calibration values are marked as
`
`cross and reference numbers are without an apostrophe; all relations determined at
`
`the same time are reference numbers 310; and all relations determined at different
`
`times are reference numbers 311.
`
`[0051.24] A complete waveform of one impulse is measured. The impulse (when the
`
`voltage value changes in time) lasts e.g. 280 us during correct stimulation. The
`
`complete voltage waveform is related (using the definition in the glossary above) to
`
`the calibration curve (stored in memory of the magnetic stimulation device). The
`
`relation is expressed by the value of a correlation coefficient which indicates the
`
`similarity of the currently measured waveform and calibration curve.
`
`Referring to Fig. 8D,
`
`the calibration voltage waveform 10 may be related to the
`
`currently measured voltage waveform 310’ with the same time duration, e.g. 350 ps,
`
`i.e.
`
`the time duration of calibration voltage waveform 310 equals the time duration of
`
`currently measured voltage waveform 310’. The complete voltage waveform need not
`
`be determined.
`
`It
`
`is sufficient to set at least one calibration value. The currently
`
`measured voltage value 310’ is related to the predetermined calibration voltage value
`
`310. The ratio of
`
`the voltage values 310, 310’
`
`(or value of voltage drop, or
`
`correlation) determines an incorrect stimulation. The currently measured voltage
`
`value 310’ and the calibration voltage value 310 may be determined at the same
`
`time.
`
`[0051.25] Referring to Fig. 8E, the calibration voltage waveform 311 may be related
`
`to the currently measured voltage waveform 311’ with a different time duration. The
`
`currently measured voltage value 311’ is measured at the time when the second
`
`maximum is reached. The measured voltage second maximum occurs at a time
`
`different than the time of second maximum of calibration curve.
`
`Turning to Fig. 8F,
`
`the currently measured voltage value 311’
`
`is related to the
`
`predetermined calibration voltage value 311. The ratio of the voltage values 11, 11’
`
`(or value of voltage drop, or correlation) determines an incorrect stimulation. The
`
`currently measured voltage value 311 and the calibration voltage value 311’ may be
`
`determined at different times. The result of the relation is the same, although the
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`S/N 15/473,390
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`Attorney Dkt. No. 066964—8046.USOO
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`currently measured voltage 311’ is measured at a different time (at time 600 us) than
`
`the calibration voltage value 311 (at time 400 us).
`
`[0051.26] Moving to Fig. 8G,
`
`the complete voltage waveform need not be
`
`determined, and any calibration voltage value does not have to be set. A relation
`
`between the currently measured voltage values 312’ and 313’ is determined. The at
`
`least two currently measured voltage values 312’, 313’
`
`in the current pulse are
`
`measured at different
`
`times of the same pulse. The system may determine an
`
`incorrect stimulation e.g. based on knowledge of the correct voltage drop. The
`
`correct voltage drop may be determined by the system manufacturer/operator as an
`
`absolute voltage value in Volts (dependent on a first maximum value); or by a ratio of
`
`currently measured voltage values with respect to a first maximum value; or a
`
`percentage of a first maximum value; or it may be derived from a mathematical
`
`model.
`
`[0051.27] In an alternative application the magnetic stimulation device may send a
`
`notification concerning the hardware error
`
`to the service department and/or
`
`manufacturer to repair the device. The magnetic stimulation device may also include
`
`a black box for storing data concerning unintended events to provide a statistics for
`
`the operator and/or the manufacturer.
`
`[0051.28] The benefit of the application is determining an unintended event within
`
`each impulse. Hence patient’s safety is significantly improved and the patient and/or
`
`the magnetic stimulation device is prevented from heat damage. Additionally,
`
`the
`
`magnetic stimulation device may be able to provide a notification concerning the
`
`unintended event to the operating personnel
`
`in human perceptible form. Further
`
`benefit is recognizing the type of unintended event.
`
`[0051.29] The application is not
`
`limited by the recited values and/or the recited
`
`characteristic quantities.
`
`Similar results may be achieved by using the current
`
`waveform/calibration curve and/or magnetic flux density waveform/calibration curve
`
`determined on the coil.
`
`[0051.30] In one embodiment, a method of controlling a magnetic stimulation device
`
`for treating a biological structure by a time-varying magnetic field includes measuring
`
`a voltage of the device over a time interval;
`
`relating the measured voltage to a
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`S/N 15/473,390
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`Attorney Dkt. No. 066964—8046.USOO
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`calibration curve; and turning the device off and/or providing a notification to the
`
`operating personnel, based on the relating of the measured voltage to the calibration
`
`curve. The method may further include determining a correlation coefficient between
`
`the measured voltage and the calibration curve; and turning the device off and/or
`
`providing a notification to the operating personnel,
`
`if the correlation coefficient
`
`is
`
`below a predetermined value.
`
`[0051.31] In another method of controlling a magnetic stimulation device for treating
`
`a biological structure by a time-varying magnetic field, steps include: measuring a
`
`voltage of the device at a time T1; relating (i.e., comparing or otherwise determining a
`
`function of)
`
`the measured voltage at time T1 to a predetermined calibration voltage
`
`at time T1; or relating the measured voltage at time T1 to a predetermined calibration
`
`voltage at time T1 + x; and then turning the device off and/or providing a notification
`
`to the operating personnel, based on the relating of the measured output voltage to
`
`the predetermined calibration voltage.
`
`[0051.32] Alternatively, a method for detecting incorrect operation of a magnetic
`
`stimulation device for treating a biological structure by a time-varying magnetic field
`
`includes:
`
`[0051.33]
`
`AA] Determining that a relation between a measured voltage of the
`
`device and a calibration curve exceeds a predetermined threshold; or
`
`[0051.34]
`
`88.] Determining that a voltage measured at a predetermined time T1
`
`and a
`
`correct voltage value of a calibration curve at
`
`time T1 exceeds a
`
`predetermined threshold; or
`
`[0051.35]
`
`CO] A relation of a first voltage measured at time T1 and a second
`
`voltage measured at time T1 + x exceeds a predefined threshold.
`
`[0051.36] The device is turned off, and/or a notification is provided to the operating
`
`personnel, based on the relating of
`
`the measured output voltage to the
`
`predetermined calibration voltage.
`
`[0051.37] According to another application of the invention at least one currently
`
`determined operation parameter may be used for determining a value of
`
`the
`
`generated heat. The generated heat may be used for prediction of a temperature of
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`S/N 15/473,390
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`the magnetic stimulation device. Typically the method may be used for treatment
`
`planning and/or to predict the temperature of the applicator and/or the part of the
`
`magnetic stimulation device which is the most susceptible to overheating such as
`
`wires and/or resistors etc.
`
`[0051.38] The magnetic stimulation device may be described by a transition thermal
`
`characteristic (TTC). The TTC may be determined by experimental measurement
`
`during standard ambient conditions such as temperature and/or pressure, or it may
`
`be a mathematical model based on technical and/or electric specifications of all
`
`components of the magnetic stimulation device. TTC characterizes the temperature
`
`dependence of the magnetic stimulation device on heat. TTC is established by the
`
`manufacturer as a factory setting.
`
`[0051.39] The value of generated heat determined by the recited application of the
`
`invention corresponds with the treatment parameters. The temperature evolution of
`
`the magnetic stimulation device is dependent during the treatment on at least one of
`
`treatment parameters, actual
`
`temperature of
`
`the magnetic stimulation device,
`
`ambient temperature, cooling medium temperature, cooling medium flow or heat
`
`dissipation.
`
`[0051.40] A calculation algorithm is set up to operate at least TTC and treatment
`
`parameters to determine the temperature of the magnetic stimulation device during
`
`the treatment. The maximal temperature of the magnetic stimulation device is limited
`
`and predetermined. However,
`
`in alternative applications the maximal temperature of
`
`the magnetic stimulation device may be adjusted by the operator. The maximal
`
`temperature may be considered to be safe for the patient.
`
`[0051.41] Fig. 10 illustrates a diagram of the calculation algorithm 314 operating with
`
`a plurality of inputs. Inputs may include TTC 315; real and/or theoretical energy loss
`
`316 (e.g. from TTC); at least one treatment parameter 317 such as repetition rate,
`
`magnetic flux density,
`
`impulse duration, amplitude modulation and/or treatment
`
`duration; actual
`
`temperature 318 of
`
`the magnetic stimulation device; cooling
`
`parameters 319 such as ambient temperature, cooling medium temperature, flow
`
`and/or pressure gradient, relative humidity, heat capacity and/or heat dissipation.
`
`Based on the input parameters the other parameters concerning the treatment may
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`Attorney Dkt. No. 066964—8046.USOO
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`be determined as a result 320.
`
`In the preferred application the real energy loss for
`
`the at least one pulse may be used.
`
`[0051.42] According to one aspect of the application, the magnetic stimulation device
`
`may stop the treatment
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`in the case that
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`the temperature determined by the
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`calculation algorithm exceeds the maximal temperature. If the calculated temperature
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`equals the maximal predetermined temperature then the treatment is started since
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`the maximal predetermined temperature is considered to be safe for the patient. The
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`treatment
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`is stopped only if
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`the calculated temperature exceeds the maximal
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`predetermined temperature.
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`[0051.43] According to another aspect of the application, the magnetic stimulation
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`device may disable the treatment in the case that the temperature determined by the
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`calculation algorithm exceeds the maximal temperature.
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`In this case the magnetic
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`stimulation device may suggest at least one maximal value of treatment parameter.
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`Based on the predicted temperature of
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`the magnetic stimulation device the
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`calculation algorithm may determine at least one value of treatment parameter to not
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`exceed the maximal
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`temperature of the magnetic stimulation device during the
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`treatment. Based on the operator’s preferences the value of the treatment parameter
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`may be automatically adjusted by the magnetic stimulation device or it may be
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`suggested to the operator in human perceptible form such as audibly perceptible
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`notification (e.g. beep) and/or visually perceptible notification (e.g. flashing light, color
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`change etc.). In an exemplary application the suggested treatment parameter may be
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`a maximal achievable value of magnetic flux density which can be sufficiently cooled
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`by the cooling system. However, any other treatment parameter may be suggested to
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`the operator.
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`[0051.44] Fig. 11 illustrates a calculation algorithm to determine a maximal magnetic
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`flux density which may be sufficiently cooled by the cooling system. As soon as the
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`magnetic stimulation device is turned on 321 the operator may set
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`the input
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`parameters 322 which are considered by the operator as suitable for the patient. Next
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`step 323 may follow.
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`In the step 33, based on the input parameters the calculation
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`algorithm may determine temperature distribution Tproc including at least one of a
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`temperature of the magnetic stimulation device determined in time t of the treatment
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`(TD(t)) and the maximal temperature of the magnetic stimulation device (TDmaX) which
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`S/N 15/473,390
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`Attorney Dkt. No. 066964—8046.USOO
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`may be reached during the treatment.
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`In the next step 324, the magnetic stimulation
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`device may determine whether the determined maximal temperature of the magnetic
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`stimulation device exceeds maximal predetermined temperature (Tmax).
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`[0051.45] In the case that TDmax exceeds Tmax,
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`in step 325 the treatment may be
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`disabled and/or a notification concerning the reason may be generated by the
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`magnetic stimulation device in a human perceptible form.
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`In the next step 326, the
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`calculation algorithm may determine at least one maximal treatment parameter which
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`may be reached to sufficiently cool the magnetic stimulation device and the magnetic
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`stimulation device may suggest at least one maximal treatment parameter to the
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`operator. Consequently, the operator may input 322 corrected treatment parameters
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`within the acceptable cooling range.
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`[0051.46] If the magnetic stimulation device determines in the step 324 that TDmax
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`doesn’t exceed Tmax, then the treatment may be started 327. Afterwards, the actual
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`temperature of the magnetic stimulation device (TM(t)) may be measured in step 328.
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`The temperature measurement may be achieved in real
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`time continuously or in
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`discrete time sequences, more preferably in predetermined discrete time values.
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`In step 239 the magnetic stimulation device may determine whether TM(t) differs from
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`the determined temperature of the magnetic stimulation device (TD(t)).
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`lf TD(t) equals
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`to TM(t) then the treatment continues 330 by generating further magnetic impulse and
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`by measuring the further TM(t) until the end 327 of the treatment and/or until the block
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`329 examines the difference in TD(t) and TM(t).
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`[0051.47] In the case that TD(t) and TM(t) differs in step 329 in consequence step 332
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`may follow.
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`In step 332 the magnetic stimulation device may examine whether the
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`TM(t) is lower than TD(t).
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`|f TM(t) is lower than TD(t) then the calculation algorithm may
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`determine at
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`least one maximal
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`treatment parameter which may be reached to
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`sufficiently cool the magnetic stimulation device and suggest in step 326 the at least
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`one new maximal treatment parameter to the operator who may adjust the at least
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`one treatment parameter in step 322. The at least one new treatment parameter may
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`be higher than the at least one originally suggested treatment parameter.
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`In the case that TM(t) is not lower than TD(t) then the magnetic stimulation device may
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`examine in step 333 whether TM(t) is lower than or equal to Tmax.
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`If TM(t) is lower than
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`S/N 15/473,390
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`Attorney Dkt. No. 066964—8046.USOO
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`Tmax then the calculation algorithm may determine at least one maximal treatment
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`parameter which may be reached in to sufficiently cool the magnetic stimulation
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`device and the magnetic stimulation device may suggest in step 326 the at least one
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`maximal
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`treatment parameter to the operator who may adjust the at
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`least one
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`treatment parameter in step 322. The at least one new treatment parameter may be
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`lower than the at least one originally suggested treatment parameter.
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`If TM(t) equals
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`to Tmax then the magnetic stimulation device may generate the notification that the
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`maximal predetermined temperature was reached.
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`[0051.48] If the magnetic stimulation device examines in step 333 that TM(t) is not
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`lower than or equal to Tmax then the treatment is disabled 334 since the temperature
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`has exceed Tmax and/or a notification may be generated by the magnetic stimulation
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`device in a human perceptible form. The calculation algorithm may determine at least
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`one maximal treatment parameter which may be reached to sufficiently cool the
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`magnetic stimulation device and suggest
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`in step 326 the at
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`least one maximal
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`