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    • 专利摘要:
    SPECIAL STIMULUS DEVICE The invention relates to a device for stimulating nerve endings located in the ear region, such a device having a therapeutic current generator powered by battery (3) arranged in a box (4) to be used in the region ear, and the same generator providing a low-frequency therapeutic current. The therapeutic current generator (3) has a plurality of output channels (9a, 9b, 9c), where each output channel is associated with its own stimulus electrode (6a, 6b, 6c), and these output channels they are connected to a micro computer circuit (10) on the input side. Each output channel (9a, 9b, 9c) contains an amplifier (15a, 15b, 15c), controlled by a digital-to-analog converter (12) and designed for amplifiers (15a, 15b, 15c), such a signal causing intensity of current and the behavior of the stimulus voltage adapting to the resistance value in that circuit and corresponding to I = kR U = kR, where k is a selectable constant. In addition, three output channels are preferably provided, each associated with its own stimulus electrode, and during the periods of current flow, the therapeutic current fed to each (...).
    公开号:BR112012005502B1
    申请号:R112012005502-0
    申请日:2010-09-13
    公开日:2020-11-24
    发明作者:Josef Constantin Szeles
    申请人:Josef Constantin Szeles；
    IPC主号:
    专利说明:

    The invention relates to a device for the punctual stimulation of nerve endings that are located in the region of the ears and run to the nuclei of the brain stem, such a device having a battery-powered therapeutic current generator, which is arranged in a housing for be used in the ear region and is provided with an electronic circuit that forms a low frequency therapeutic current, and whose device still has at least two flexible lines that extend from the therapeutic current generator to connect, in each case, to a stimulus needle electrode to be positioned at a nerve end.
    An object of the invention is to provide a device of the type mentioned above, which offers a greater spectrum of possibilities with regard to the details of stimulus and, therefore, allows to reach a broader range of therapeutic application. In addition, it must be possible for the device to be provided so that the effect of influences that can affect the stimulus, for example, the effect of forces acting from outside on the electrodes or the effect of changes in resistance values on electrode region, may remain small or can be compensated.
    The device, according to the invention of the type mentioned above, is characterized by the fact that the therapeutic current generator has a plurality of analog output channels, in which each of these output channels is associated with its own stimulus electrode, and these analog output channels to control the therapeutic current are each individually connected to a microcomputer circuit in which the parameter values for the therapeutic currents provided for the respective therapy can be stored in a storage, to be available for a continuous reading. With this configuration, the aforementioned objective can be readily achieved. For example, in the case of a loosening, caused externally, of the adjustment of a stimulus electrode with an initially good electrical conductivity or, for example, in the case of a rapid increase in the electrical resistance of the subcutaneous tissue at the injection site of an electrode. stimulus, the stimulating function of the respective stimulus electrode can be affected, but a stimulus, although limited, can still occur with another stimulus electrode that, as mentioned, is connected to its own output channel. In addition, in the case of functional errors in the region of a reference electrode, the stimulus can be maintained by properly controlling the output channels, which are independent of each other, in which a current flow is established which is fed through two or more stimulus electrodes. The presence of a plurality of output channels also offers the possibility of stimulating, in different regions of receptors in which different nerve endings are located, with therapeutic currents that differ in terms of their parameters. Thus, in different locations of the ear, the stimulus with different intensity can be provided and, for example, sympathetic and parasympathetic nerve cords can optionally be stimulated. The parameters of therapeutic currents can be selected or defined in a simple way in a wide range, in which, for example, a change can occur from therapeutic currents of high intensity, which are formed from a series of pulse packs and they are particularly suitable for pain therapy in the acute phase, for low intensity therapeutic currents that are formed by individual pulses and are particularly suitable for pain therapy in the case of chronic pain, where it is also possible during such treatment to provide a slow increase intensity at the beginning of treatment and a slow decay at the end of treatment.
    A preferred mode of the device, according to the invention, is characterized by the fact that in the individual output channels, in each case, an amplifier is provided which is controlled by a digital-to-analog converter and configured for bipolar output signals, in that the digital-to-analog converter, in turn, is connected to a digital connection of the microcomputer circuit. For this reason, a favorable implementation can be obtained if in the individual output channels the operational amplifiers are provided as amplifiers.
    The collection, in each case, of the values that occur in the currents fed during a stimulus treatment for the stimulus electrodes and the voltages, in each case, present in these stimulus electrodes, is advantageous to program the parameters of the therapeutic currents and to maintain the same during the stimulus. For this, it is provided, according to the preferred modalities of the device according to the invention, on the one hand, that in the output channels, in the current pathways that lead to the stimulus electrodes, measurement resistors for current measurement are inserted and that, for individual measuring resistors, in each case, a measuring amplifier is connected, its output signal is a measure of the current intensity of the therapeutic current and is fed to the microcomputer circuit, and on the other hand , it is provided that at least in one output channel, a voltage measurement circuit is provided which emits to the microcomputer circuit a measurement signal that corresponds to the voltage that is present between the stimulus electrode associated with the relevant output channel and a potential reference point that is located on the therapeutic current generator and is preferably connected to a reference electrode.
    A device design, according to the invention, which is especially advantageous with regard to a selectable configuration of the intensity of the therapeutic currents and which also offers the advantage that, in the event of an unintended increase in electrical resistance in the circuits powered by stimulus electrodes, the increase of which may be a result of increases in resistance in the skin or subcutaneous tissue or a loosening of the adjustment of a stimulus electrode, voltage peaks are not created which, in certain circumstances, are perceived as unpleasant, it is characterized that in the microcomputer circuit, a constant voltage control circuit is provided, which is optionally operable by external activation and is operationally connected to an internal storage for the therapy current parameters and which feeds a control signal through a digital-to-analog converter for at least one amplifier provided on one channel of output, such a control signal causing, in the output circuit of the amplifier connected to a stimulus electrode, the behavior of a constant voltage source, which is adjustable in relation to the voltage value. It is also an advantage here if it is provided that in the constant voltage control circuit, a constant voltage feedback control circuit is integrated, to which the measurement signal from the relevant voltage measurement circuit is fed as a real signal.
    If the focus is on maintaining a certain selected intensity of the therapeutic current, a device modality is advantageous, according to the invention, characterized by the fact that, in the microcomputer circuit, a constant current control circuit is provided, which it is optionally triggerable by external activation and is operationally connected to an internal storage for therapeutic current parameters and that feeds a control signal through a digital-analog converter to at least one amplifier provided in an output channel, such a control signal causing , in the output circuit of the amplifier connected to a stimulus electrode, the behavior of a constant voltage source, which is adjustable in relation to the voltage value, and that, in the constant voltage control circuit, a voltage control circuit is integrated. constant voltage feedback, to which the measurement signal from the relevant voltage measurement circuit is fed as a signal l real.
    Another configuration of the device, according to the invention, with which the advantageous property can be achieved, is that the sensation and the effect of the stimulus remain substantially unchanged even during the occurrence of changes in the electrical resistance in the respective stimulus circuit, in which this applies to the treatment of several different medical conditions, it is characterized by the fact that, in the microcomputer circuit, an adaptive current control circuit is provided, which is optionally triggerable by external activation and which is operationally connected to an internal storage for parameters of therapeutic current and that feeds a control signal through a digital-analog converter to at least one amplifier provided in an output channel, such a control signal causing, in the amplifier's output circuit connected to a stimulus electrode, a behavior of stimulus voltage and current intensity that adapts to the resistance value in such an output circuit and corresponds to the relations I = k-R U = k R2 where k is a selectable constant. It is advantageously provided here that, in the adaptive current control circuit, an adaptive current feedback control circuit is integrated into which, as a real signal, a resistance measurement value is obtained which is obtained from the measurement signal. of the voltage measurement circuit and the output signal from the current measurement measurement amplifier. In particular, in order to ensure that a sensation accompanying the stimulus remains unchanged, a device configuration according to the invention, which is characterized by the fact that the control circuit - which is provided in the microcomputer circuit and which feeds a control signal to the amplifiers provided in the output channels, and that such signal, in a cyclic succession, forms time intervals in which a current flow to the stimulus electrodes occurs and the time intervals in which the output are inactive, in which, in each case, a current flow time interval and an inactive time interval form a stimulus cycle together - causes a variation in the average current intensity determined over the duration of a cycle. stimulus for the variation of such duration through the control signal.
    For stimulus therapy in the case of certain disorders or diseases and, for example, to achieve a homogeneous sensation throughout the ear, it is advantageous to continuously change the polarity of the therapeutic currents. For this, a configuration of the device of the invention is provided which is characterized by the fact that, during a current flow of the therapeutic currents fed to the individual stimulus electrodes, these stimulus electrodes, at the moment considered, in each case, have polarities that differ from each other in relation to a potential reference point that is connected with the therapeutic current circuits. This configuration also results in at least partial relief of a reference electrode connected to the potential reference point from the therapeutic currents that flow through the stimulus electrodes. This effect applies to a greater extent for a refinement that is characterized by the fact that the therapeutic currents, which are fed to the individual stimulus electrodes that have polarities that differ from each other at the time considered respectively, compensate each other in the time considered respectively so that no therapeutic current flows through a reference electrode. In this way, a reference electrode can be eliminated. It is additionally advantageous if it is provided that the control circuit - which is provided in the microcomputer circuit and which feeds a control signal to the amplifiers provided in the output channels, and that such control signal, in a cyclic succession, forms intervals of times in which a current flow to the stimulus electrodes occurs and time intervals in which the output channels are inactive, in which, in each case, a current flow time interval and an inactive time interval form together a stimulus cycle, and in which, in the current flow time intervals, a therapeutic current flow as a packet of successive pulses or as a single pulse - causes an inversion of polarity in each time interval of current flow. It is preferably provided in this connection that the polarity inversion is caused within the current flow time intervals. This is often considered to be therapeutically advantageous.
    From a therapeutic point of view and also with regard to reducing or even preventing a flow of the therapeutic current through a reference electrode, a configuration of the device of the invention that is characterized by the fact that the control circuit - that is provided in the microcomputer circuit and that feeds a control signal to the amplifiers provided in the output channels, and that such signal, in a cyclic succession, forms time intervals in which a current flow to the stimulus electrodes occurs and intervals times in which the output channels are inactive, in which, in each case, a current flow time interval and an inactive time interval form a stimulus cycle together - they cause during the current flow time individual intervals one or a plurality of changes in the intensity of the therapeutic currents fed to the individual stimulus electrodes, in which changes in intensity that occur in u A stimulus electrode considered respectively are contrary to the intensity changes that occur in one or a plurality of other stimulus electrodes considered respectively. This can be applied even with only two output channels and the stimulus electrodes; however, it appears to be more viable with three or more output channels and stimulus electrodes. A preferred configuration is characterized, in this context, by the fact that three output channels are provided, each associated with its own stimulus electrode, and the therapeutic current, which is fed within the current flow time intervals for each individual stimulus electrode is compensated for intensity and polarity at each point in time considered respectively by the therapeutic currents that are fed, in each case, to the other two stimulus electrodes.
    Particularly focused on pain therapy in chronic cases, but also suitable in other cases is a device configuration that is characterized by the fact that the therapeutic currents fed to the individual stimulus electrodes are formed in each current flow interval by one single pulse and, with each of these individual pulses, a plurality of intensity changes and at least one reversal of polarity are provided in chronological succession. Here, an implementation in connection with three output channels is preferred. To achieve the mentioned mutual compensation, it is advantageous to provide that the change, single or repeated, of the intensity of the therapeutic current provided in the intervals of the flow of the individual current occurs in an incremental way.
    As already mentioned above, it is advantageous for certain stimulus therapies, for example, pain therapies for chronic disorders, starting with low values at the beginning of treatment and slowly increasing the intensity of the stimulus to the full extent desired. For this, according to the invention, a device modality is provided, which is characterized by the fact that the control circuit - which is provided in the microcomputer circuit and which feeds a control signal to the amplifiers provided in the output channels, and such a signal, in a cyclic succession, forms time intervals in which a current flow to the stimulus electrodes occurs and the time intervals in which the output channels are inactive, in which case, in each case, a time interval current flow and an inactive time interval together form a stimulus cycle - at the beginning of a stimulus cycle sequence formed by a multiplicity of successive stimulus cycles, it continually increases during a plurality of successive stimulus cycles from, in each case, a stimulus cycle for the next stimulus cycle following the intensity of the therapeutic current fed to a stimulus electrode considered respectively, the intensity being considered as average during the respective current flow time interval and, subsequently, it maintains during a multiplicity of successive stimulus cycles within its current flow time intervals than the previously obtained level of therapeutic current intensity. Thus, the sensation of the stimulus, as well as the effect of the treatment, can be further improved if it is provided that, at the end of the stimulus cycle sequence, the control circuit feeds a control signal to the amplifiers provided in the output channels, and this control signal decreases continuously from, in each case, a stimulus cycle for the next stimulus cycle that the intensity of the therapeutic current fed to a stimulus electrode considered respectively, the intensity being considered as average during the interval of flow time of the respective current.
    Regarding the power supply of the device, according to the invention, a modality is preferential, which is characterized by the fact that, to supply the amplifiers provided in the output channels, a voltage transformer with an output is provided. bipolar, which, in turn, is provided by the battery provided in the device. In this way, the supply of the amplifiers can be carried out with a battery that is formed from a single cell or a few cells and, in a given space, has a relatively high energy content, which allows a stimulation operation for several days. Another possible extension of the treatment duration with the device can be achieved by minimizing the losses that occur in the mentioned voltage transformer. For this, an improvement of the aforementioned modality provides that, in the connection of the battery supply to the voltage transformer, a switching device is inserted that interrupts the supply during the pauses of the current flow present in the therapeutic current circuits, as well as in an excess of the predefined limit value of the current consumed by the battery voltage transformer. In addition to the energy-saving function, the switching device has the function of protecting against battery overload and against exceeding predefined values of therapeutic currents.
    Another modality that is effective in terms of the best possible use of the energy contained in the supply battery is characterized by the fact that, to supply the microcomputer circuit, the digital-to-analog converter and the potentially provided measurement signal circuits, a voltage transformer that has a unipolar output and is connected to the battery, in which such voltage transformer is deflected with a Schottky diode and is activated only when the battery voltage drops, and distributes a voltage corresponding to the target voltage at its output battery.
    To define the parameters of the therapeutic currents for the respective case of treatment present, a device modality, according to the invention, is advantageous and preferred, which is characterized by the fact that the device has a transmission device that operates wirelessly connected to the microcomputer circuit and serves, by means of an external control device, for the insertion of parameters, to be stored, of the therapeutic currents provided for the respective treatment. In addition, it may be advantageous to provide that the device has a transmission device that operates wirelessly, which is connected to the microcomputer circuit and serves to transmit stored parameters of the therapeutic currents provided for the respective treatment to an external monitoring and control device. .
    As an external control device, a conventional computer can be used that has an interface to which an adapter that is provided with a transceiver device can be connected.
    For a wireless transmission, it is possible to advantageously use devices that operate in a band within the scope of the decimetric wave provided for control purposes. However, other devices that transmit control information in the infrared environment can also be used. The simplest modalities are also possible, in which the control information, which corresponds to the parameters of the therapeutic currents provided, is stored in such a device during its manufacture.
    The invention is now further explained by means of examples with reference to the figures in which examples of the modalities are illustrated schematically. In the figures:
    Fig. 1 shows an exemplary embodiment of a device configured according to the invention in a schematically illustrated block diagram.
    Figs. 2, 3 and 4 show diagrams that illustrate different ways of controlling the therapeutic currents provided for the stimulus.
    Figs. 5 to 10 show time diagrams showing the curve of the currents provided for the stimulus, which occur in different modalities of the device according to the invention.
    Fig. 11 shows a block diagram of an embodiment of a voltage supply circuit provided in the device according to the invention.
    The modality shown in fig. 1 in a schematic block diagram of a device configured in accordance with the invention is provided for the punctual stimulation of nerve endings which are located in the region of the ears and run to the nuclei of the brain stem.
    This device 1 has a therapeutic current generator powered by battery 3 arranged in a housing 4, to be used in the region of an ear 2 where the stimulus must be performed. Regarding the dimensions of the device 1, it should be mentioned that the illustration in fig. 1 is intended to mainly illustrate the construction and functional characteristics, and the dimensions of the housing 4 involving the device components can generally be kept smaller than the dimensions of the ear 2. The battery powered therapeutic current generator 3 contains a circuit electronic device that forms a low frequency therapeutic current that feeds, through flexible lines 5a, 5b, 5c, the stimulus needle electrodes 6a, 6b, 6c to be disposed in ear 2. A reference electrode, which, in the case illustrated , is configured as a needle electrode 7 is connected via a flexible connection 8 to a potential reference point 0 of the device. The reference electrode 7 can also be configured in a different way, for example, in the form of a surface electrode which, as illustrated, can be arranged in a flexible connection 8 or can also be mechanically connected in a different way over the housing 4 of the device. Within the context of the aforementioned electronic circuit, the current generator 3 has a plurality of analog output channels 9a, 9b, 9c, each of which output channels is associated with its own stimulus electrodes 6a, 6b, 6c and provides therapeutic current for these electrodes. The mentioned analog output channels are each individually connected on the input side to a microcomputer circuit 10 in which the values of the therapeutic current parameters provided for the respective treatment can be stored in a storage 11, to be available for reading to be continued. In the individual output channels 9a, 9b, 9c, in each case, an amplifier 15a, 15b, 15c is provided which is controlled by a digital-to-analog converter 12 and is configured for bipolar output signals. Constructively advantageous, digital-to-analog converters are combined to form a unit, but can also be applied separately. The digital-to-analog converter 12, in turn, is connected to a digital connection 13 of the microcomputer circuit 10. At least two of the mentioned output channels, which are each associated with its own stimulus electrode, preferably three of them output channels, as illustrated, are provided. However, if desired, a greater number of such output channels and associated stimulus electrodes can be provided. As an amplifier 15a, 15b, 15c, preferably an operational amplifier is provided.
    In the current pathways 16a, 16b, 16c, located in the output channels 9a, 9b, 9c and running towards the stimulus electrodes 6a, 6b, 6c, measurement resistors 17a, 17b, 17c are inserted, which serve to measure the intensity therapeutic currents. In each case, a measuring amplifier 18a, 18b, 18c is connected to the individual measuring resistors 17a, 17b, 17c, whose output signal is a measure of the current intensity of the therapeutic current, and this output signal is fed to the microcomputer circuit 10. Also provided in the output channels 9a, 9b, 9c are voltage measurement circuits 19a, 19b, 19c, each transmitting to the microcomputer circuit 10 a measurement signal that corresponds to the voltage that is present between stimulus electrode 6a, 6b, 6c associated with the relevant output channel and reference potential 0 or reference electrode 7.
    Provided in the microcomputer circuit 10 is a constant voltage control circuit 20 which is optionally operable by external activation and which is operationally connected to the internal storage 11 for therapeutic current parameters and which, through the digital-analog converter 12, supplies a control signal through outputs 14a, 14b, 14c of the digital-to-analog converter 12 to at least one amplifier 15a, 15b, 15c, which are each provided in an output channel 9a, 9b, 9c, such signal control provoking, in the respective amplifier output circle 15a, 15b, 15c connected to a stimulus electrode 6a, 6b, 6c, the behavior of a constant voltage source that is adjustable in relation to the voltage value. It is preferably provided here, as illustrated in fig. 1, that in the constant voltage control circuit 20, a constant voltage feedback control circuit 23 is integrated into which the measurement signal of the relevant voltage measurement circuit 19a, 19b, 19c is fed as a real signal. In addition, a constant current control circuit 21 is provided, which is optionally operable by external activation and is also operationally connected to internal storage 11 for therapeutic current parameters and which feeds a control signal through the digital-to-analog converter 12, at the outputs 14a, 14b, 14c, to which the amplifiers 15a, 15b, 15c are connected, for at least one of these amplifiers, such a control signal causing, in the output circuits 15a, 15b, 15c of this amplifier connected to an electrode of stimulus 6a, 6b, 6c, the behavior of a constant current source that is adjustable in relation to the current intensity; here, in the constant current control circuit 21, a constant voltage feedback control circuit 24 is integrated, for which the output signal of the measuring amplifier 18a, 18b, 18c, associated with the amplifiers 15a, 15b, 15c considered respectively, it is fed as a real signal.
    In addition, an adaptive current control circuit 22 is provided in the microcomputer circuit 10, which is optionally operable by external activation and operationally connected to the internal storage 11 for therapeutic current parameters and which feeds a control signal to at least one amplifier 15a, 15b, 15c provided in an output channel 9a, 9b, 9c, such a control signal causing, in the respective output circuit 15a, 15b, 15c of the amplifier connected to a stimulus electrode 6a, 6b, 6c, a behavior current intensity and stimulus voltage, which adapts to the resistance value in this output circuit and corresponds to the relations I = kR U = k-R2 where k is a selectable constant. Preferably, an adaptive voltage feedback control circuit 25 is integrated into the adaptive current control circuit 22, for which a resistance measurement value obtained from the voltage measurement signal of the respective voltage measurement circuit 9a , 19b, 19c and the output signal of the respective measuring amplifier 18a, 18b, 18c, is fed as a real signal. To form the resistance measurement value, a resistance calculation circuit 26 is provided in the microcomputer circuit 10.
    The determination of resistance or also of a voltage measurement with the voltage measurement circuit mentioned above can also be used to check if the stimulus electrodes were correctly placed during placement.
    In the sense of a different usability of the device, it is possible, as illustrated in fig. 1, provide the three different control circuits 20, 21, 22 in the microcomputer circuit 10; however, it is also possible, in the sense of simplifying or adapting the device to certain forms of therapies, to provide only one or two of these control circuits. It is also possible, as shown, to provide in the housing 4 of the device, the supply battery 27 and the wireless transmission device 29, which, for example, is equipped with an antenna and serves to enter parameters, to be stored, therapeutic currents provided for the respective treatment and which, in turn, are connected to the microcomputer circuit 10.
    It is constructionally and functionally advantageous, if it is provided that the microcomputer circuit 10 with its storage 11 and the control circuits 20, 21, 22, 26 and, preferably also the components that form the output channels 9a, 9b, 9c and are associated with these output channels, are integrated in an integrated circuit. Components that serve for wireless transmission of therapeutic current parameters can also be involved in such integration. Figs. 2, 3 and 4 illustrate the relationship between the current and voltage values acting on the electrodes and the electrical resistance that is present in different modes of operation in the respective current circuit that runs from the amplifier located in the respective output channel through associated stimulus electrode. Fig. 2 shows in this connection, when, in the mentioned current circuit, which runs through the stimulus electrode, the amplifier present in the respective output channel has the behavior of an adjustable constant voltage source. A plurality of selectable voltage values are designated with U1, U2 and U3, and the current flowing in each case results from the intersection of the resistance line designated with R with the voltage value set in each case. The voltage (U1, U2, U3) fixed in each case is applied to the stimulus electrode, and the current I flowing through the stimulus electrode decreases with increasing resistance in the stimulus electrode circuit and increases with decreasing resistance. An increase in resistance R is shown in fig. 2 with +, and a decrease in resistance R is indicated with -. Fig. 3 illustrates the relationships when in the respective output circuit of an amplifier provided in an output channel, that such an output circuit is connected to a stimulus electrode, the behavior of a constant current source adjustable in relation to the current intensity is present . Three optionally adjustable current values 11, I2, I3 are indicated. The voltage that occurs in the stimulus electrode considered in each case increases with increasing resistance and decreases with decreasing resistance. Fig. 4 shows the relationships, in the case of a current intensity and behavior of the stimulus voltage, with the behavior adapting to the resistance value present in the current circuit of a stimulus electrode and an adaptive control of the amplifier corresponding to the relations I = kR U = k-R2 The values of the current intensity of the current flowing through the relevant stimulus electrode and the values of the voltage applied to the stimulus electrode, whose values are interconnected, in each case, are in characteristic curves of the parabola type, and two such characteristic curves that apply to different values of k are drawn in fig. 4 and are designated with k1 and k2. The values of current intensity and stimulus voltage, resulting from a given resistance value in the current circuit flowing through the stimulus electrode, are given, in each case, by the intersection of the resistance line R with the characteristic line. which corresponds to the respective k value. When the resistance value decreases, the current and voltage in the stimulus circuit decreases and, conversely, the current and voltage in the stimulus circuit increase as the resistance acting in the stimulus circuit increases. Such adaptable behavior of the voltage and current values in the stimulus electrode considered respectively offers the advantage of an adaptation to the existing sensation in many patients, according to which, in the case of low values of the stimulus current, the changes of the latter are intensely felt , whereas, in the case of high values of the stimulus current, changes in the current are felt in a significantly smaller dimension. A stimulus treatment generally lasts over relatively long periods, in which the time intervals during which a current flow to the stimulus electrodes occurs alternate with time intervals in which the current flow is interrupted. In most cases, short current flow time slots and short inactive time slots are provided in an alternating sequence and after a relatively high number of such cycles, relatively long breaks are provided, for example, with a duration of 1 hour. Fig. 5 shows the chronological sequence of such a stimulus, in which the current flow time intervals 30 alternate in a cyclic succession with inactive time intervals 31 and, in each case, a current flow time interval 30 and one inactive time interval 31 together form a stimulus cycle 32. In the flow time intervals of current 30, the therapeutic current takes the form of a successive pulse packet 33, each of which lasts, for example, several milliseconds. During each time interval of current flow 30, in the case illustrated in fig. 4 at the beginning of said interval, an inversion of the polarity of the therapeutic current occurs. Fig. 6 shows a variant of the chronological sequence of a stimulus treatment illustrated in fig. 5, in which, in the case illustrated in fig. 6, the therapeutic current flowing in the flow time intervals of the current 30 has in each said time interval 30 the shape of a single pulse 34. At the beginning of each flow interval of the current 30, analogous to the sequence illustrated in fig . 5, a reversal of the polarity of the therapeutic current occurs. In figs. 5 and 6, the stimulus pulses are illustrated with a constant voltage value, corresponding to the behavior as a constant voltage source of the amplifiers provided in the output channels of the device according to the invention. Fig. 7 shows the chronological sequence of an additional form of the stimulus. Here, the therapeutic current flowing in the flow time intervals of the current 30 is in the form of double pulses 35, 36, whose polarities are opposite to each other, in which the polarity inversion occurs during the flow time intervals. of current 30. In this modality, which focuses, in particular, on an adaptive feedback control of the therapeutic current, it is provided that the intensity of the therapeutic current is varied to adapt to the conditions present in each case. Here, on the one hand, the inactive time intervals of the stimulus cycles are varied, whereby also the duration of the stimulus cycles is changed, in which, for example, the inactive time intervals 31b are longer than the interval inactive time 31 and, correspondingly, stimulus cycles 32b are longer than stimulus cycle 32a. In this way, a variation in the average current intensity, determined over the duration of a stimulus cycle, is obtained by varying the duration of the stimulus cycle. The current intensity must be considered here based on the sum of the individual pulses 35, 36, while polarity inversion is neglected. In addition, following a stimulus process illustrated in fig. 7, a variation in the amplitude of the therapeutic currents is provided. Fig. 8 shows, in a chronological sequence, the therapeutic currents that are present in two stimulus electrodes that are associated, in each case, with an output channel of the device, according to the invention. Here, the therapeutic currents are formed in the flow intervals of the current 30, in each case, by a packet of successive pulses 33, in which, in each case, during the transition from a packet of these pulses 33 to the next packet of these pulses, an inversion of polarity 37 occurs. In relation to a reference electrode connected to the therapeutic current circuits, the therapeutic current fed in the current 30 flow intervals to the stimulus electrode 6a has a different polarity in relation to the therapeutic current fed in the time interval of current flow 30 to stimulus electrode 6b. Since, in addition, the intensities of the pulses 33 of the therapeutic current fed to the stimulus electrode 6a are equal to the intensities of the pulses 33 of the therapeutic current fed to the stimulus electrode 6b and compensate each other due to the different polarities at the point at respectively considered time, this results in that no therapeutic current flows through a reference electrode that is connected to the therapeutic current circuits. In the case of unequal intensities of the pulses of the therapeutic current fed to the stimulus electrodes 6a, 6b, only partial compensation is obtained and a flow of the current occurs, albeit a reduced one, through such reference electrode. Fig. 9 shows the chronological sequence of the therapeutic currents that are fed to three stimulus electrodes 6a, 6b, 6c, in which these stimulus electrodes, in turn, are associated, in each case, with an output channel of a device configured for according to the invention. The therapeutic currents fed to the individual stimulus electrodes 6a, 6b, 6c are formed at each time interval of current flow 30 by a single pulse 34, in which, in each of these individual pulses, a plurality of intensity changes are provided successively chronologically and polarity inversions 37.The changes in intensity of therapeutic currents occur incrementally. It is applied here that the changes in intensity that occur in the stimulus electrode considered respectively running against the changes in intensity that occur in one or a plurality of other stimulus electrodes considered respectively. By mutually adapting the extent of intensity changes, it is achieved that at each point in time considered within the current flow time intervals, the therapeutic current fed to each individual stimulus electrode 6a, 6b, 6c is compensated for respect to the intensity and polarity by the therapeutic currents fed to, in each case, two other stimulus electrodes 6a, 6b, 6c. This results in no therapeutic current flowing through a reference electrode provided in the device. In addition, uncertain contacts that potentially occur in one of the stimulus electrodes are largely compensated automatically, in which case also, a compensation current that potentially flows through a reference electrode remains low.
    For the flow of the therapeutic current illustrated in fig. 10, it is provided that, at the beginning 38 of a sequence of stimulus cycles formed by a multiplicity of successive stimulus cycles 32, during a plurality of successive stimulus cycles, the intensity of the therapeutic current fed to a stimulus electrode considered respectively 6a , 6b, 6c, the intensity being considered as average during the respective flow time interval of the current 30, is continuously increased from, in each case, a stimulus cycle 32 to the next next stimulus cycle, and then is maintained during a multiplicity of successive stimulus cycles at the intensity level previously reached. At the end 39 of the stimulus cycle sequence, the intensity of the therapeutic current fed to a stimulus electrode considered respectively is continuously reduced from, in each case, a stimulus cycle to the next stimulus cycle.
    The characteristics of the exemplary modalities of the therapeutic current time sequences provided for the stimulus should not only be seen in connection with the respective exemplary modality, but can also be combined with each other, in the context of the invention. In particular, the time sequences as shown in figures 5, 6, 7 and 10, which, for better understanding, are illustrated for an output channel, can also be used, according to the concept of the invention, for a plurality of output channels, in which in relation to the parameters of the stimulus pulses to be provided, in all cases there are different possibilities. Therefore, it is possible in the different exemplary modalities to optionally provide successive pulse packages or individual pulses, in which different variants of polarity inversions and changes in intensity are feasible. In addition to supplying different currents for the different stimulus electrodes, as mentioned here, a simultaneous supply to these electrodes is also optionally possible.
    In the embodiment illustrated in fig. 11 of an operating supply voltage circuit provided in a device configured in accordance with the invention, a voltage transformer 40 with a bipolar output is provided for supplying the amplifiers 15a, 15b, 15c provided in the output channels 9a, 9b, 9c, in which such a voltage transformer, in turn, is supplied by the battery 27 provided in the device. In the supply connection 41 that goes from the battery 27 to the voltage transformer 40, a switching device 42 is inserted, which, while being controlled by the microcomputer circuit 10, interrupts the supply to the voltage transformer 40 during the pauses of the current flow occurring in therapeutic current circuits and also in case of exceeding a predefined limit value of the current consumed by the voltage transformer 40 from battery 27. For the supply of the microcomputer circuit 10, the digital-to-analog converter 12 and potentially provided measurement signal circuits 18a, 18b, 18c, 19a, 19b, 19c, a voltage transformer 43 is provided, which has a unipolar output and is connected to the battery 27, in which said transformer is deflected with a diode de Schottky 44 and is activated only when the battery voltage drops, and distributes a voltage corresponding to the target battery voltage at its output.
    The transmission device 29 is preferably configured to introduce parameters to be stored from the therapeutic currents provided for the respective treatment, as well as for transmission to an external control and monitoring device for the parameters of the therapeutic current provided for the respective treatment, whose parameters are stored in storage 11 of microcomputer circuit 10.
    权利要求:
    Claims (17)
    [0001]
    1. Device (1) for the punctual stimulus of nerve endings that are located in the region of the ears and run to the nuclei of the brain stem, such a device (1) having a therapeutic current generator powered by battery (3), which is arranged in a housing (4) to be used in an ear region and is provided with an electronic circuit (10, 12), forming a low frequency therapeutic current, and that the device (1) has at least two flexible lines (5a, 5b, 5c) that extend from the therapeutic current generator (3) to connect in each case to a stimulus needle electrode (6a, 6b, 6c) to be positioned at a nerve end, in whereas the therapeutic current generator (3) has a plurality of analog operating output channels (9a, 9b, 9c), where each of these output channels is associated with its own stimulus electrode (6a, 6b, 6c), and these analog operating output channels to control the therapeutic current are, in each case, individually connected by the input side to a microcomputer circuit (10) in which the values of the therapeutic current parameters provided for the respective treatments can be stored in a memory (11) to be available for reading continuous, characterized by the fact that, in the microcomputer circuit (10), an adaptive current control circuit (22) is provided, which is optionally triggerable by external activation and is operationally connected to an internal memory (11) for parameters of therapeutic current and that, through a digital-to-analog converter (12) connected to a digital connection (13) of the microcomputer circuit (10), feeds a control signal to at least one amplifier (15a, 15b, 15c) provided in an output channel (9a, 9b, 9c) and configured for bipolar output signals, such a control signal causing, in the respective amplifier output circuit (15a, 15b, 15c) connected to an e stimulus electrode (6a, 6b, 6c), a behavior of current intensity and stimulus voltage that adapts to the respective resistance value in this output circuit and corresponds to the relations I = k RU = k - R2 J where k is a selectable constant.
    [0002]
    2. Device (1), according to claim 1, characterized by the fact that, in the output channels (9a, 9b, 9c), measurement resistors (17a, 17b, 17c) for the current measurement are inserted in the current pathways (16a, 16b, 16c) running to the stimulus electrodes (6a, 6b, 6c), and a measurement amplifier (18a, 18b, 18c) is connected to each of the individual measurement resistors (17a, 17b) , 17c), whose output signal is a measure for the current intensity of the therapeutic current and is fed to the microcomputer circuit (10), and is provided, for a voltage measurement circuit (19a, 19b, 19c) by minus an output channel (9a, 9b, 9c) that sends a measurement signal to the microcomputer circuit (10), such a measurement signal corresponding to the voltage that is present between the associated stimulus electrode (6a, 6b, 6c) to the relevant output channel and a potential reference point (0) which is located on the therapeutic current generator (3) which is connected to the m reference electrode (7).
    [0003]
    3. Device (1) according to claim 1 or 2, characterized by the fact that, in the adaptive current control circuit (22), an adaptive current feedback control circuit (25) is integrated for the which a resistance measurement value obtained from the measurement signal of the voltage measurement circuit (19a, 19b, 19c) and the output amplifier signal (18a, 18b, 18c) of the current measurement is fed as a real sign.
    [0004]
    4. Device (1), according to claim 1, characterized by the fact that the control circuit (20, 21, 22) which is provided in the microcomputer circuit (10) and which feeds a control signal to the amplifiers (15a, 15b, 15c) provided in the output channels, that such a signal, in a cyclic succession, forms time intervals (30) in which a current flow to the stimulus electrodes occurs and the time intervals (31) in the which output channels are inactive, in which, in each case, a current flow time interval (30) and an inactive time interval (31) together form a stimulus cycle (32) - causes a variation in the mean the intensity of the current determined over the duration of a stimulus cycle (32) by varying this duration through the control signal.
    [0005]
    5. Device (1), according to claim 1, characterized by the fact that, in the microcomputer circuit (10), a constant voltage control circuit (20) is provided, which is optionally operable by external activation and is operationally connected to an internal memory (11) for therapeutic current parameters and which, through a digital-to-analog converter (12), feeds a control signal to at least one amplifier (15a, 15b, 15c) provided in a channel of output (9a, 9b, 9c), such a control signal causing, in this amplifier output circuit (15a, 15b, 15c) connected to a stimulus electrode (6a, 6b, 6c), the behavior of a constant voltage source that it is adjustable in relation to the voltage value.
    [0006]
    6. Device (1), according to claims 2 and 5, characterized by the fact that, in the constant voltage control circuit (20), a constant voltage feedback control circuit (23) is integrated for the which the measurement signal from the relevant voltage measurement circuit (19a, 19b, 19c) is fed as a real signal.
    [0007]
    7.Device (1), according to claims 1 and 2, characterized by the fact that, in the microcomputer circuit (10), a constant current control circuit (21) is provided that is optionally operable by external activation and it is operationally connected to an internal memory (11) for therapeutic current parameters and which, through a digital-to-analog converter (12), feeds a control signal to at least one amplifier (15a, 15b, 15c) provided in a output channel (9a, 9b, 9c), such a control signal causing, in this output channel of the amplifier (15a, 15b, 15c) connected to a stimulus electrode (6a, 6b, 6c), the behavior of a source of constant current, which is adjustable in relation to the current intensity, and a constant current feedback control circuit (24) is integrated in the constant current control circuit (21) for which the output signal from the measuring amplifier (18a, 18b, 18c) is fed as a re signal al.
    [0008]
    8. Device (1) according to any one of claims 1 to 7, characterized in that the control circuit (20, 21, 22) provided in the microcomputer circuit (10) feeds a control signal to the amplifiers (15a, 15b, 15c) provided in the output channels, that such a signal, in a cyclic succession, forms time intervals (30) in which a current flow to the stimulus electrodes occurs and the time intervals (31) in which the output channels are inactive, in which case, in each case, it causes an inversion of polarity during a current flow time interval (30), in which a respective current flow time interval (30) and a respective inactive time interval (31) together form a stimulus cycle (32) - and, in the current flow time intervals (30), a therapeutic current flows in the form of a successive pulse packet (33) or in the form of single pulse (34).
    [0009]
    9. Device (1) according to any one of claims 1 to 8, characterized by the fact that a control circuit (20, 21,22) - which is provided on the microcomputer circuit (10) and which feeds a signal control for the amplifiers (15a, 15b, 15c) provided in the output channels, that such a signal, in a cyclic succession, forms time intervals (30) in which a current flow to the stimulus electrodes occurs and time intervals (31 ) in which the output channels are inactive, in which, in each case, a time interval of the current flow (30) and a respective time interval (31) respectively form a stimulus cycle (32) - causes , during each of the individual current flow time intervals, one or a plurality of changes in the intensity of the therapeutic currents fed to the individual stimulus electrodes, in which the intensity changes, occurring in a stimulus electrode considered respectively (6a, 6b, 6c) being observed, run against the intensity changes that occur in one or a plurality of other stimulus electrodes considered respectively (n) that are being observed.
    [0010]
    10. Device (1), according to claim 9, characterized by the fact that three output channels are provided, each associated with its own stimulus electrode, and the therapeutic current, which is fed within the intervals of current flow time for each individual stimulus electrode (6a, 6b, 6c) is compensated for in relation to the intensity and polarity at each point in time considered respectively by the therapeutic currents that are fed in each case to the other two stimulus electrodes (6a, 6b, 6c).
    [0011]
    11. Device (1) according to claim 9 or 10, characterized by the fact that the therapeutic currents fed to the individual stimulus electrodes (6a, 6b, 6c) at each time interval of the current flow (30) they are formed by a single pulse (34) and in each of these individual pulses, a plurality of intensity changes and at least one polarity inversion (37) are provided in chronological succession.
    [0012]
    12. Device (1) according to any one of claims 1 to 11, characterized by the fact that the repeated or single change in the intensity of the therapeutic current provided in the intervals of the individual current flow (30) occurs gradually.
    [0013]
    13. Device (1) according to any one of claims 8 to 12, characterized by the fact that the control circuit (20, 21, 22) - which is provided in the microcomputer circuit (10) and which feeds a signal control for the amplifiers (15a, 15b, 15c) provided in the output channels, that such a signal, in a cyclic succession, forms time intervals (30) in which a current flow to the stimulus electrodes occurs and the time intervals (31) in which the output channels are inactive, in which case, in each case, a time interval of the current flow (30) and a respective time interval (31) respectively form a stimulus cycle (32) - at the beginning (38) of a stimulus cycle sequence formed by a multiplicity of successive stimulus cycles (32), it increases continuously, during a plurality of successive stimulus cycles, starting from, in each case, a stimulus cycle (32) for the next stimulus cycle, the intensity of the therapeutic current utica fed to a stimulus electrode considered respectively (6a, 6b, 6c) being observed, the intensity being considered as average during the respective time interval of the current flow (30) and, subsequently, it maintains, during a multiplicity of successive stimulus cycles, within their current flow time intervals, the level of intensity of the therapeutic currents previously obtained.
    [0014]
    14. Device (1), according to claim 13, characterized by the fact that at the end (39) of the stimulus cycle sequence, the control circuit feeds a control signal to the amplifiers provided in the output channels, such as control signal decreases continuously, in each case, from a respective stimulus cycle (32) for the next stimulus cycle, the intensity of the therapeutic current fed to a stimulus electrode considered respectively (6a, 6b, 6c) which is being observed, the intensity being considered as an average during the respective current flow time interval.
    [0015]
    15. Device (1) according to any one of claims 1 to 14, characterized by the fact that, for the supply of the amplifiers (15a, 15b, 15c) provided in the output channels (9a, 9b, 9c), it is a voltage transformer (40) with a bipolar output is provided, such a transformer, in turn, is provided by the battery (27) provided in the device.
    [0016]
    16. Device (1) according to claim 15, characterized by the fact that, in the supply connection (41) that runs from the battery (27) to the voltage transformer (40), a device for insertion is inserted switching (42) that interrupts the supply during the pauses of the current flow present in the therapeutic current circuits, as well as during the exceedance of a predefined limit value of the current consumed by the voltage transformer (40) from the battery (27).
    [0017]
    17. Device (1) according to any one of claims 1 to 16, characterized by the fact that, for the supply of the microcomputer circuit (10), the digital-to-analog converter (12) and measurement signal circuits ( 18a, 18b, 18c, 19a, 19b, 19c) provided in the device (1), a voltage transformer (43) is provided that has a unipolar output and is connected to the battery (27), in which such voltage transformer is deflected with a Schottky diode (44) and is only activated when the battery voltage drops, and distributes a voltage that corresponds to the target battery voltage at its output.
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    同族专利:
    公开号 | 公开日
    JP6231276B2|2017-11-15|
    WO2011030210A1|2011-03-17|
    BR112012005502A2|2017-03-01|
    CN102548611B|2014-09-10|
    CN102548611A|2012-07-04|
    JP2013504357A|2013-02-07|
    EP2477691B1|2014-05-21|
    AT11955U1|2011-08-15|
    US20120226333A1|2012-09-06|
    BR112012005502B8|2021-06-22|
    US8942814B2|2015-01-27|
    ES2486258T3|2014-08-18|
    EP2477691A1|2012-07-25|
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    法律状态:
    2017-10-03| B25A| Requested transfer of rights approved|Owner name: JOSEF CONSTANTIN SZELES (AT) |
    2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-07-23| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-07-14| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-11-24| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 24/11/2020, OBSERVADAS AS CONDICOES LEGAIS. |
    2021-06-22| B16C| Correction of notification of the grant|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 13/09/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO |
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    AT0057209U|AT11955U1|2009-09-14|2009-09-14|DEVICE FOR PUNCTUAL STIMULATION|
    ATGM572/2009|2009-09-14|
    PCT/IB2010/002261|WO2011030210A1|2009-09-14|2010-09-13|Punctual stimulation device|
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