WO2022214196A1 - Dispositif médical et procédé de fonctionnement d'un dispositif médical - Google Patents

Dispositif médical et procédé de fonctionnement d'un dispositif médical Download PDF

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Publication number
WO2022214196A1
WO2022214196A1 PCT/EP2021/059300 EP2021059300W WO2022214196A1 WO 2022214196 A1 WO2022214196 A1 WO 2022214196A1 EP 2021059300 W EP2021059300 W EP 2021059300W WO 2022214196 A1 WO2022214196 A1 WO 2022214196A1
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WO
WIPO (PCT)
Prior art keywords
signal
source
current source
medical device
analog signal
Prior art date
Application number
PCT/EP2021/059300
Other languages
English (en)
Inventor
Marc Vancraeyenest
Cosmin Damian IONESCU
Original Assignee
Azyro Sa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Azyro Sa filed Critical Azyro Sa
Priority to PCT/EP2021/059300 priority Critical patent/WO2022214196A1/fr
Priority to DE212021000559.4U priority patent/DE212021000559U1/de
Publication of WO2022214196A1 publication Critical patent/WO2022214196A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0452—Specially adapted for transcutaneous muscle stimulation [TMS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36031—Control systems using physiological parameters for adjustment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36034—Control systems specified by the stimulation parameters

Definitions

  • the present invention relates to a medical device for providing an electrical stimulation to a subject. Further, the present invention relates to a therapy and/or diagnostic device, a method for operating a medical device and/or therapy and/or diagnostic device, and to a computer program element configured, when executed, to perform the above method.
  • a subject i.e. a human or animal body
  • some biological processes are known to be linked to electricity.
  • the functional basis of sensory, nerve and muscle cells is based on the generation, transmission and processing of electrical impulses containing information.
  • the beating of the heart is triggered by electrical impulses, the control of muscles occurs through electrical signals, and when thinking, brain currents flow more, etc.
  • a bloodvessel may act as a transmission line to conduct electricity.
  • electrical models can also be formed to tissue, bone, nerve, proteins, etc.
  • proteins may act as a semi-conductor
  • tissues and bones may act as crystalline arrays
  • nerves and muscles may conduct electromagnetically signals, etc.
  • the cell membrane may be described by an electrical model, in which the cell membrane model includes various ionic conductance and electromotive forces in parallel with a capacitor.
  • diseases particularly if they are triggered by pathogens, such as bacteria, parasites, fungi, viruses, etc., in the human or animal body are based at least in part on the above structures, such as proteins, DNA, cells, etc., and/or electrical mechanisms, such as model able electrical behavior, they are likely to be subject to influence them by electrical processes.
  • pathogens such as bacteria, parasites, fungi, viruses, etc.
  • a medical device for providing an electrical stimulation to a subject.
  • the medical device may be configured to provide one or more electric current signals selected and/or specified to influence, e.g. stimulate, a pathogen, such as a bacteria, fungus, virus, parasites, etc., present at, particularly in or on, the subject in a frequency domain harmful to the pathogen.
  • a pathogen such as a bacteria, fungus, virus, parasites, etc.
  • Pathogens can be influenced electrically because they are composed, for example, of cells, cell membranes, proteins, DNA, or the like, all of which are based on electrical processes and can be modeled electrically.
  • exemplary mechanisms of action harmful to the pathogen may rely on stimulating the pathogen or components thereof by applying the electric current signal in a specific frequency domain.
  • the frequency domain may be chosen to comply with a resonance frequency domain, or the like, of the pathogen.
  • the medical device may preferably serve therapeutic and/or diagnostic purposes.
  • the medical device comprises: a controller, comprising at least a signal source configured to generate a first analog signal output with a first phase and, simultaneously, a second analog signal with a second phase phase- shifted to the first phase; a first voltage-controlled current source, connected to the signal source to receive the first analog signal and to generate, based on the received first analog signal, an electric current, and configured to provide a first output impedance; a second voltage-controlled current source, connected to the signal source to receive the second analog signal and to generate, based on the received second analog signal, an electric current, and configured to provide a second output impedance different to the first output impedance; a first applicator, configured to be brought into contact with the subject and connected to the first current source; and a second applicator, configured to be brought into contact with the subject and connected to the second current source.
  • a controller comprising at least a signal source configured to generate a first analog signal output with a first phase and, simultaneously, a second analog signal with a second phase phase- shifted
  • an improved medical device for generating electric current and/or corresponding signals, preferably for therapy purposes, e.g. stimulation, of the subject, e.g. a human or animal.
  • the medical device is particularly configured to apply, for example, electric currents suitable for penetrating intracellular living tissues, to penetrate or pass inside cells, or the like, to the subject.
  • the medical device may be configured to deliver sufficiently high voltages to the subject via the applicators, i.e. the first and second applicator.
  • using at least two current sources, i.e. the first and second current source may allow to increase, especially double, the output voltage capability of the medical device.
  • the at least two current sources are connectable or connected in series with the subject, which may also be referred to as a load in a correspondingly formed electrical circuit.
  • phase shift between the at least two current sources may allow a wide range of frequencies of the electric currents to be generated, and may particularly allow to increase the frequencies of the electric currents generated.
  • the output voltage of the medical device may be controlled at least one of the applicators.
  • the medical device may be able to control its output voltage.
  • the output voltage potential at the second applicator may be controlled based on a variable impedance, i.e. a variable second impedance. Further, the output voltage potential at the second applicator may be referenced around zero.
  • the medical device may be configured, by utilizing the first and second current source, to provide an accurate current signal amplitude in the milliamps range, for example, with e.g. 0,5 milliamps (mA) to 20 mA or more, preferably with 1 mA to 15 mA or more.
  • the medical device is configured to generate and/or emit micro-currents and/or bio-currents.
  • a bio-current may be understood as a current, defined by e.g. an amplitude, signal shape, or the like, configured to generate a resonance in an organism.
  • the medical device may be configured, by utilizing the first and second current source, to provide an electrical current signal with frequencies from DC to 300 Megahertz (MHz), preferably from DC to 3 MHz.
  • the medical device may be configured to provide a resolution of at least 0,6 micro Amps (mA).
  • the medical device comprises a power supply, which preferably is galvanically insulated, e.g. a mains connection.
  • the medical device may be configured, e.g. by operating the first and/or second current source, to provide the electric current signal in a specific signal shape or waveform, which may also comprise one or more sequences of specific signal shapes or waveforms and/or one or more combinations of signal shapes or waveforms.
  • the specific signal shape or waveform may be sine, half sine, saw-tooth, triangle, line, DC, square, pulse, sine-segment, trapezoidal segment, Gaussian distribution, ECG, an arbitrary waveform, or the like.
  • the medical device may be configured to vary one or more parameters of the specific signal shape or waveform, such as duration, frequency, phase, duty cycle, pulse, offset, and/or amplitude.
  • the specific signal shape or waveform and/or one or more of its parameters may be variable and/or programmable, e.g. by manipulating via an input interface, such as a data interface, user interface, etc. Further, one or more of and may form a control program.
  • the control program may be provided to the controller, e.g. as control data, which may control the first and/or second current source to generate the programmed specific signal or waveform provided with the control program.
  • the controller may be broadly understood and/or as an arrangement of electrical and/or electronic components and/or software components that can perform control of the medical device based on at least a control program, and optionally further based on one or more feedback signals, as described herein. Accordingly, the controller may be implemented either in hardware, in software or in a combination of hardware and software, and may be configured to control operation of hardware and/or software components of the medical device, based on the control program. It is noted that the control program, when serving therapeutic purposes, may also be referred to as therapy program, wherein the control program comprises instructions to generate the electric current signals in a way so as to influence the subject in a manner being preferably harmful to it.
  • the controller comprises the signal source configured to generate a first analog signal output with a first phase and, simultaneously, a second analog signal with a second phase phase-shifted to the first phase.
  • the signal source may comprise one or more of a digital-to-analog converter, DAC, which can be operatively coupled to a digital signal generator on the input side and to the first and second current sources on the output side, one or more amplifiers, and a calibration unit.
  • the controller may comprise one or more of a processor, a memory, e.g. a volatile and/or non-volatile memory, one or more data interfaces, for example, to a personal computer on which the above control program may be generated, e.g.
  • the controller may be configured to receive the control program and to generate control signals to operate on this basis the first and second current source to output electrical current and/or voltage, and/or to vary the output impedance, in accordance with the control program.
  • FSM finite state machine
  • the controller may be configured to receive the control program and to generate control signals to operate on this basis the first and second current source to output electrical current and/or voltage, and/or to vary the output impedance, in accordance with the control program.
  • the subject to be influenced, e.g. stimulated, by the medical device may be broadly understood, and may, for example, be a human or animal, a body thereof or a part of it.
  • the subject may also be an in vitro substance, e.g. a pathogen, an organism, or the like, such as one cultivated in a Petri dish, test tube, or the like, wherein the substance is influenced by the electrical current of the medical device.
  • the first current source and the second current source may be understood as any suitable voltage-controlled current source configured to maintain a constant electrical current value on its output side, meaning a constant current source.
  • the first and second current source may be of a same type configured to maintain the constant current value though the load even if the value of load resistance, i.e. impedance, changes.
  • the second current source is adapted to provide the second output impedance different from the first output impedance of the first current source.
  • the first current source may be a Howland current source as known in the art, comprising an operational amplifier and a resistor bridge that is balanced.
  • the second current source may be a Howland current source, comprising an operational amplifier and adapted to comprise a resistor bridge that is unbalanced.
  • the first current source may be configured to comprise a first resistor bridge with a balanced matching condition of its resistors
  • the second current source may be configured to comprise a second resistor bridge with an unbalanced resistors matching condition.
  • the unbalance of the second resistor bridge of the second current source may be variable.
  • the second output impedance is lower than the first output impedance.
  • the first and second applicator may be understood broadly as an electrically conductive interface that can be brought, preferably non-invasively, into electrically conductive contact with the subject to provide the electrical current generated by the medical device to the subject.
  • the first and/or second applicator may comprise one or more of a skin electrode, a head electrode, which can optionally be arranged in a kind of helmet, or the like.
  • the applicator may comprise a needle, which may be used on the skin and/or dermis, epidermis or hypodermis, etc.
  • the first and second applicator may differ in type from each other.
  • the first phase and second phase of the analog signals may be opposite to each other, i.e. having a 180° phase shift.
  • the first and second analog signal may be generated and/or provided by the signal source in a 180° phase shift.
  • the signal source provides two, basically or actually equal, differential input signals with 180° phase shift from each other. In this way a wide range of frequencies of the electrical current generated by the first and second current source may be provided.
  • the first current source and/or the second current source may comprise an operational amplifier, OP AMP, connected to the signal source and a resistor bridge connected to the OP AMP.
  • the first resistor bridge of the first current source may be, with respect to a resistor matching condition, i.e. a resistance equation of the resistors used in the resistor bridge, balanced.
  • the second resistor bridge of the second current source may be, with respect to a resistor matching condition, i.e. a resistance equation of the resistors used in the resistor bridge, unbalanced, i.e. satisfying an inequality with respect to a resistor matching condition of the resistors used in the resistor bridge.
  • the output impedance of the second current source may be varied and/or adjusted by varying and/or adjusting a resistance value of the resistance bridge, and particularly of one or more of its resistors.
  • the second current source may, for example, comprise a first resistor Ri, a second resistor R 2 , a third resistor R 3 , a fourth resistor R 4 , and a fifth resistor R 5 , wherein the corresponding resistor matching condition may be expressed by R 1 [(R 4 + AR) + ? 5 ] 1
  • the second current source may utilize the differential capabilities of the OP AMP to detect a voltage across R 4 , which may therefore be referred to as a sense resistor, and control on this basis a current flow through the load, i.e. the subject. Thereby, a corresponding feedback signal may be used to control the resistance value.
  • the OPAMP may be provided in a bootstrap manner where both negative and positive feedback is utilized.
  • the second output impedance may be controlled, i.e. varied and/or adjusted, by varying and/or adjusting one or more resistance values.
  • the second output impedance may be provided by adjusting a resistance value of at least one resistor of the resistor bridge of the second current source. As explained above, this may allow to control the second output impedance of the second current source, further allowing to provide a common mode voltage that is stable and controllable, e.g. around zero level.
  • the medical device e.g. the controller, may further comprise: at least one (first) detection unit, connected to an output side of one of the current sources as a first input and connected to receive the analog signal as a second input, wherein the controller is further configured to disable at least the signal source, if a value, such as a voltage level, of the output side of the current source approaches the analog signal above a threshold in a comparison of the two inputs.
  • first detection unit connected to an output side of one of the current sources as a first input and connected to receive the analog signal as a second input
  • the controller is further configured to disable at least the signal source, if a value, such as a voltage level, of the output side of the current source approaches the analog signal above a threshold in a comparison of the two inputs.
  • the medical device may comprise, e.g. as part of the controller, the (first) detection unit configured to detect voltage saturation at the output side of the medical device. Therefore, the detection unit may also be referred to as a (quasi-)peak and/or voltage saturation detector.
  • the detection unit may comprise at least a comparator, e.g. an analog comparator, connected to the output side of the medical device, e.g. to the output side of the first and/or second current source to receive the corresponding electrical signal as a first input, and connected to the signal source to receive the analog signal as a second input.
  • the comparator is configured to compare both input signals with each other and to set an indicator value if the output side of the current source approaches the analog signal above a threshold in a comparison of the two input signals.
  • the indicator value set by the comparator indicates the voltage saturation status on the first and/or second applicator. If the voltage saturation status is too high, i.e. reaches and/or exceeds the threshold, the indicator value may be used to control the signal source and/or the first and/or second current source to be automatically disabled.
  • the threshold may be set to be below the power supply limit of the medical device, and may particularly be set to 75 % to 95 %, preferably to about 95 %, of the output voltage of the medical device, meaning that the output of the medical device is controlled to be disabled if the output voltage at first and/or second current source is close to the power supply limit.
  • the medical device may be configured to disconnect the first and/or second applicator based on the indicator value.
  • the (first) detection unit is implemented in hardware, e.g. by using an analog comparator and/or a rectifier connected thereto, in order to reduce latency in controlling the output of the medical device to be disabled.
  • the number of detection units may comply with the number of current sources, so that each current source is connected to a corresponding detection unit. In this way, detecting and/or monitoring the voltage saturation by the comparator may allow to improve safety of the subject, by disabling the output of electric signals towards the subject. Further, the indicator value may indicate a detachment of the first and/or second applicator from the subject.
  • the medical device may further comprise: at least one (second) detection unit, connected to an output side of one of the current sources as a first input and connected to receive the analog signal as a second input ; wherein the controller is further configured to control an output gain of the signal source and/or the first and/or second current source, if a value of the output side of the current source approaches the analog signal above a threshold in a comparison of the two inputs.
  • at least one (second) detection unit connected to an output side of one of the current sources as a first input and connected to receive the analog signal as a second input ; wherein the controller is further configured to control an output gain of the signal source and/or the first and/or second current source, if a value of the output side of the current source approaches the analog signal above a threshold in a comparison of the two inputs.
  • the medical device may comprise, e.g. as part of the controller, the (second) detection unit configured to detect voltage saturation at the output side of the medical device and to control the output gain of the medical device.
  • the detection unit may be formed as a circuit and may comprise a comparator, e.g. an analog comparator, connected to the output side of the medical device, e.g. to the output side of the first and/or second current source to receive the corresponding electrical signal as a first input, and connected to the signal source to receive the analog signal as a second input.
  • the comparator may be configured to compare both input signals with each other and to set an indicator value if the output side of the current source approaches the analog signal above a threshold in a comparison of the two input signals.
  • the indicator value indicates a voltage saturation condition at the output side of the medical device, i.e. at the first and/or second current source.
  • the medical device e.g. the controller, may control, e.g. adjust, the signal source to adjust the analog signal to avoid voltage saturation at the output side of the medical device, i.e. the first and/or second current source, and/or at the first and/or second applicator.
  • the signal source may receive as an input an amplification value, which is set based on the indicator value set by the detection unit, wherein the amplification value may be decreased if the voltage saturation is too high or may be maintained or increased if the voltage saturation is low enough.
  • the number of detection units may comply with the number of current sources. In this way, an automatic gain controlled can be provided to avoid voltage saturation at the output side of the medical device, e.g. at the first and/or second applicator. Further, the electric current signal at the output side of the medical device may be controlled, and preferably limited based on the indicator value.
  • first detection circuit and the second detection unit may be the same unit, e.g. circuit, or may use at least partly some common components, or may be separated from each other.
  • the medical device e.g. the controller, may further comprise: at least one calibration unit, comprising at least one calibration resistor, and being selectively connectable to an output side of one of the first current source and/or second current source instead of the first applicator and/or second applicator, wherein the controller is further configured to generate, based on a value detected at the at least one calibration resistor, a calibration parameter to be provided to the signal source to generate the analog signal.
  • at least one calibration unit comprising at least one calibration resistor, and being selectively connectable to an output side of one of the first current source and/or second current source instead of the first applicator and/or second applicator, wherein the controller is further configured to generate, based on a value detected at the at least one calibration resistor, a calibration parameter to be provided to the signal source to generate the analog signal.
  • the medical device may comprise, e.g. as part of the controller, the calibration unit configured to calibrate, e.g. adjust, e.g. a zero level and/or full scale level of the medical device, i.e. the first and/or second current source.
  • the output side of the corresponding first and/or second current source may, preferably circuit-based, be disconnected from the first and/or second applicator and connected to the calibration unit.
  • the calibration unit may comprise one or more specific calibration resistors. Thereby, the output signal, i.e. the electric current signal, of the corresponding first and/or second current source may be transformed in voltage and then measured.
  • the medical device e.g.
  • the controller may be configured to generate, based on the measurement, at least one calibration value, which is considered for generating the analog signal of the signal source.
  • the calibration unit may comprise a differential amplifier, configured to transform the output signal, i.e. the electric current signal, of the corresponding first and/or second current source to voltage, and an analog-to-digital converter to provide measurement and to generate the calibration values, e.g. the calibration value Kx.
  • the medical device may allow automatic calibration, preferably performed at initial start of the medical device and/or a therapy application.
  • the medical device e.g. the controller, may further comprise: a signal generator, connected to the signal source and configured to provide at least a source signal of the first and/or second analog signal based on one or more signal parameters describing the corresponding analog signal to be output by the signal source.
  • a signal generator connected to the signal source and configured to provide at least a source signal of the first and/or second analog signal based on one or more signal parameters describing the corresponding analog signal to be output by the signal source.
  • the signal generator receives only one or more signal parameters that describe the corresponding analog signal to be output by the signal source, instead of receiving the control program, e.g. therapy program, sample by sample, i.e. in sample by sample data.
  • the one or more signal parameters may comprise one or more of a signal shape or waveform, amplitude, frequency, and signal duration.
  • the signal generator may receive the control program, which may correspond to the therapy program to be applied to the subject, and may generate, based on the control program, a corresponding control signal to control the signal source to generate and/or output the corresponding analog signal. In this way, by utilizing only the signal parameters instead of sample by sample data, the amount of data to generate the analog signal may be reduced.
  • the medical device e.g. the controller, and preferably the signal generator, is further configured to provide the one or more signal parameters such that the signal parameters are provided with signal parameter information indicating over which application time the one or more signal parameters remain unchanged or to be changed.
  • the medical device utilizes only information of length of time with regard to changes or non-changes of the one or more signal parameters according to a predefined function, instead of also specifying the exact signal parameters for each time point.
  • This mechanism may also referred to as time slot concept, in which the time slot is defined as the length of time that the one or more signal parameters remain unchanged or are changed according to a predefined function.
  • the time slot may be further defined or dimensioned with a length of time within which a reaction or response of the subject, i.e. the body or the substance, can be expected or even recognized, i.e. a reaction or response can be measured.
  • the time slot may have a length of time in the range of Milliseconds (ms), but is not limited thereto. In this way, the size of data files of the control program may be reduced, as it only comprise a reduced amount of information.
  • the medical device e.g. the controller, may further comprise: at least one measuring unit, connectable to the subject and configured to receive one or more measurement signals assigned to impedance of the subject, wherein the controller is further configured to control the signal source and/or the first and/or second current source based on the measured impedance.
  • the medical device e.g. the controller
  • the medical device may be configured to measure, preferably, in real-time, the impedance, e.g. the skin impedance, of the subject between the first and second applicator, and to provide the one or more signals assigned to that impedance.
  • the medical device e.g. the controller
  • the controller may be configured to control the signal source and/or the first and/or second current source based on the one or more signals assigned to impedance of the subject. In this way, a feedback loop from the subject to the controller may be provided.
  • the medical device may further comprise: a first clock, associated with the one or more signal parameters; and a second clock, associated with the measurement signals assigned to impedance of the subject; wherein the controller is further configured to synchronize the first clock and the second clock, i.e. synchronize the first clock with the second clock, or vice versa.
  • the impedance feedback can be synchronized in time with the control signals and/or signal parameters included in the control program, which may allow an accurate analysis of the effect of the control program caused at the subject based on the impedance feedback.
  • Using the real-time synchronization between the signal parameters included in the control program and the impedance feed may be used to implement variation of the signal parameters until the desired effect can be measured at the subject.
  • the medical device may further comprise: at least one electric charge determining unit, configured to determine an, preferably cumulated, electric charge to be applied or applied to the subject, wherein the controller is further configured to control the signal source and/or the first and/or second current source based on the determined electric charge.
  • the medical device e.g. the controller
  • the medical device may be configured to determine, the, preferably cumulated, electric charge to be applied or applied to the subject via the first and second applicator, and to consider this information about the electric charge for controlling the first and/or second current source.
  • the electric charge may be calculated and/or determined directly or indirectly, preferably in Coulomb (C).
  • the electric charge determining unit may be implemented in software only, in hardware only, or in a combination of hardware and software.
  • the software may record the current generated by the medical device over time and determine the amount of charge from this, e.g. by calculation.
  • the electric charge determining means may comprise at least one integrator, e.g. an integrating amplifier using an OP AMP, in order to provide a signal assigned to the number of electric charges.
  • the controller may be configured to control the signal source and/or the first and/or second current source based on the determined electric charge applied to the subject. In this way, a feedback loop from the subject to the controller may also be provided. In this way, even a prediction of the electric charges and/or electric current to be applied may be performed by the controller.
  • This determination, e.g. calculation and/or measurement, of electric charges may be performed in real-time, i.e. during ongoing operation, of the medical device and/or application of the electric current.
  • the electric charge determining unit and/or the controller may be configured to determine a number of electric charges. This number of electric charges may be compared, with regard to the effect to be caused at the subject, with a weight or dose of a medicine administered to the subject, and to its pharmacological effect, respectively. Therefore, the medical device may be configured to determine and set, control and/or adjust, preferably in real time, the exact dose of electric charges and/or electric current to be applied, similar to the administration of a medicine with a specific dose.
  • a therapy and/or diagnostic device is provided. It is configured to stimulate a pathogen present on or in a subject by applying an electric current to the subject, wherein the therapy device comprises at least one medical device according to the first aspect.
  • the pathogen may be a bacteria, parasite, fungus, virus, or the like, which is electrically stimulated, excited or the like by the therapy device.
  • the pathogen may be electrically stimulated or excited in such a way that it self- destructs or at least weakens.
  • level, frequency, etc., of the electrical signal output by the medical device may be selected to trigger a corresponding weakened or self-destroying mechanism of the pathogen.
  • proteins, cells, etc. or structures of the pathogen can be modified and e.g. also destroyed.
  • the therapy and/or diagnostic device may comprise a number of channels each comprising at least an arrangement of a signal source, a first current source and a second current source.
  • the therapy device may comprise a plurality of medical devices according to the first aspect, wherein each channel may be controlled separately from the others.
  • the therapy and/or diagnostic device may further comprise: a therapy editor, configured to provide a selection of partial signals and/or signal parameters for assembling a signal sequence, and to provide a signal sequence generated based on the selection to a signal source of the medical device.
  • the therapy editor may be implemented in software and may provide a graphical user interface, GUI, configured to provide the selection of partial signals and/or signal parameters to a user, i.e. someone who creates the control program, i.e. the therapy program.
  • the partial signals and/or signal parameters may comprise one or more of a signal shape, signal duration, signal frequency, phase, duty cycle, pulse, offset, and amplitude.
  • the selection may be defined for time intervals in e.g. milliseconds (ms) up to hours (h).
  • ms milliseconds
  • h hours
  • a method for operating a medical device may be applied, for example, to the medical device according to the first aspect and/or to the therapy and/or diagnostic device according to the second aspect. Accordingly, the technical means, units and/or devices defined in the following method may correspond to that of the first aspect as described above.
  • the method may be computer-implemented, and may be implemented either in hardware or in software, or by a combination of hardware and software.
  • the method comprises: providing, by a signal source, a first analog signal with a first phase and, simultaneously, a second analog signal with a second phase phase-shifted to the first phase.
  • an accurate electric current signal may be provided to the subject, in order to provide electrical stimulation to the subject.
  • the first and/or second impedance may be controlled by adjusting a resistance value of at least one resistor of the resistor bridge of the first and/or second current source to cause the resistor bridge to be unbalanced.
  • output impedance and/or current flow through the subject i.e. the load, may be controlled.
  • the method may further comprise: connecting a detection unit to an output side of one of the current sources as a first input and connected to receive the corresponding analog signal as a second input, and disabling, by a controller, at least the signal source, if a value of the output side of the current source approaches the corresponding analog signal above a threshold in a comparison of the two inputs.
  • a voltage saturation detection mechanism may be provided. Further, the electric current signal may be limited. As a result, safety of the subject may be improved by automatically disabling the output side of the medical device based on the measurements of the detection unit.
  • the method may further comprise: connecting, by a controller, a detection unit to an output side of one of the current sources as a first input and connected to receive the analog signal as a second input; and controlling, by the controller, an output gain of the signal source, if a value of the output side of the current source approaches the analog signal above a threshold in a comparison of the two inputs.
  • an automatic gain control at the output side of the medical device may be provided.
  • accuracy of the electric current signal may be improved.
  • safety of the subject may be improved by automatically adjusting gain at the output side of the medical device based on the measurements of the detection unit.
  • the method may further comprise: selectively connecting, by the controller, a calibration unit, comprising at least one calibration resistor, to an output side of one of the first current source and/or second current source instead of the first applicator and/or second applicator; and generating, by the controller, based on a value detected at the at least one calibration resistor, a calibration parameter to be provided to the signal source to generate the analog signal.
  • an automatic calibration of the medical device may be provided.
  • This calibration procedure may preferably be performed at initial start of the medical device.
  • the method may further comprise: obtaining, by the controller, one or more signal parameters of at least a source signal of the corresponding analog signal by using signal parameter information indicating over which application time the one or more signal parameters remain unchanged or to be changed, and generating, by the controller, the source signal and/or the analog signal based on the signal parameter information.
  • the amount of data required to generate therapy signal i.e. the electric current signal output by the medical device
  • the control program i.e. therapy program
  • a computer program element which when executed by a processor is configured to carry out the method of the third aspect, and/or to control a device according to the second aspect, and/or to control a device according to the first aspect.
  • a computer-readable storage or transmission medium which has stored or which carries the computer program element according to the fourth aspect.
  • the above embodiments may be combined with each other irrespective of the aspect involved. Accordingly, the method may be combined with structural features of the device of the other aspects and, likewise, the devices of the first and/or second aspect may be combined with features of each other, and may also be combined with features described above with regard to the method according to the third aspect.
  • Fig 1 shows in a schematic block diagram a medical device according to an embodiment.
  • Fig. 2 shows in a schematic block diagram a medical device according to an embodiment.
  • Fig. 3 shows in a schematic block diagram a medical device according to an embodiment.
  • Fig. 4 shows in a schematic front view a therapy and/or diagnostic device comprising at least one medical device, according to an embodiment.
  • Fig. 5 shows in a flow chart a method for operating a medical device and/or a therapy and/or diagnostic device, according to an embodiment.
  • Fig. 1 shows in a schematic block diagram an exemplary embodiment of a medical device 100, which is configured to provide an electric current signal to a subject S.
  • the electric current signal preferably serves for providing a specific therapy, e.g. a therapy program comprising one or more specific electric current signals, to the subject S.
  • the electric current signal may be selected and/or specified to stimulate a pathogen, such as a bacteria, fungus, virus etc., present at the subject in a frequency domain harmful to the pathogen.
  • a pathogen such as a bacteria, fungus, virus etc.
  • the medical device 100 further comprises a controller 110, which may be divided into one or more sub-units or functional units.
  • the nomenclature 110-xx may indicate that the correspondingly designated unit can, optionally, be structurally and/or functionally associated with the controller 110.
  • the sub-units or functional units designated by the above nomenclature at least in part are separated from the controller 110.
  • the controller 110 comprises at least a signal source 110-10 configured to generate an analog signal Sx, and particularly a first analog signal output with a first phase and, simultaneously, a second analog signal with a second phase phase-shifted to the first phase.
  • the first and second analog signal which may be designated as Sxl and Sx2, may be equal to each other (and may therefore be summarized under designation Sx, i.e. it may be a common signal that is picked up phase-shifted), but may be generated or provided with a phase-shift to each other.
  • the first and second analog signal Sxl, Sx2 may be composite to each other, i.e. having a 180° phase-shift to each other.
  • the analog signal Sx, Sxl, Sx2 may be generated based on a control program, which is described below in more detail.
  • the medical device 100 further comprises a first voltage-controlled current source 120, connected to the signal source 110-10 to receive the first analog signal Sxl and to generate, based on the received first analog signal Sxl, an electric current signal, and configured to provide a first output impedance. Thereby, by varying the first analog signal Sxl, the electric current signal at the output side of the first current source 120 may be controlled.
  • the medical device 100 comprises a second voltage-controlled current source 130, connected to the signal source 110-10 to receive the second analog signal Sx2 and to generate, based on the received second analog signal, an electric current, and configured to provide a second output impedance different to the first output impedance.
  • the electric current signal at the output side of the second current source 130 may be controlled.
  • the second output impedance may be lower than the first output impedance. This may result in the medical device 100 obtaining control of the output potential at the second current source 130.
  • the second output impedance of the second current source 130 may be variable or adjustable within the second current source 130.
  • the first current source 120 and the second current source 130 are connected in series with the subject S. This may result in the output voltage capability of the medical device 100 to be increased, and particularly in case of at least two current sources to be at least doubled.
  • the medical device 100 comprises a first applicator 140, configured to be brought into contact with the subject S and connected to the first current source 120.
  • the first applicator 140 may be an electrically conductive interface to the subject S, such as a skin applicator, attachable to the body, extremities, head, an in vitro arrangement, etc.
  • the first applicator 140 may be connected to the first current source 120 via an electric line that is connected with the other side to a suitable output interface of the medical device 100.
  • the electrical current signal generated by the first current source 120 may then be transmitted to the first applicator 140, from which the electric current is passed to the subject S.
  • the medical device 100 comprises a second applicator 150, configured to be brought into contact with the subject S and connected to the second current source 130.
  • the second applicator 150 may be an electrically conductive interface to the subject S, such as a skin applicator, a needle applicator, or the like, attachable to the body, extremities, head, an in vitro arrangement, etc.
  • the second applicator 150 may be connected to the second current source 130 via an electric line that is connected with the other side to a suitable output interface of the medical device 100. The electrical current signal generated by the second current source 130 may then be transmitted to the second applicator 150, from which the electric current is passed to the subject S.
  • Fig. 2 shows in a schematic block diagram the medical device 100 in more detail, according to an exemplary embodiment.
  • Fig. 2 shows the medical device 100 from Fig. 1, but for better understanding shows more details of the components, units and/or circuits used.
  • the first current source 120 and the second current source 130 each comprise an operational amplifier 120-1, 130-1, OP AMP 120-1, 130-1, connected to the signal source 111 and a resistor bridge 120-2 connected to the corresponding OP AMP 120-1, 130-1.
  • An input side of the OP AMP 120-1 of the first current source 120 is connected to the signal source 111 to receive the analog signal Sx with the first phase (Sxl as shown in Fig. 1)
  • an input side of the OP AMP 130-1 of the second current source 130 is connected to the signal source 111 to receive the analog differential signal Sx with the second phase (Sx2 as shown in Fig. 1).
  • the analog signal Sx, Sxl, Sx2 may be a differential signal, it, and particularly the first and second analog signal Sxl, Sx2 may also be designated as +Sxl and -Sx2, as indicated in Fig. 2 (and also in Fig. 3).
  • the resistor bridge 120-2, 130-2 of the first current source 120 and second current source 130 each comprise resistors Rl, R2, R4 and R5, connected as shown in Fig. 2 as an example. It is noted that at least one of the resistors Rl, R2, R4 and R5 of the resistor bridge 120-2 of the second current source 130 is configured to be adjustable in terms of its resistance value.
  • the controller 110 is configured to vary and/or adjust the resistance value of the resistor bridge 130-2 of the second current source 130, thereby causing the resistor bridge 120-2 to be unbalanced.
  • the resistor bridge 130-2 is unbalanced in terms of a corresponding resistor matching condition that may be expressed by ⁇ [( R 4 + AR ) + R 5 ] 1 R2R3 , wherein the variable and/or adjustable resistance value is indicated by AR.
  • the medical device 100 comprises, e.g. as part of the controller 110, a signal generator 110-20, connected, with its output side, to the signal source 111 and configured to provide at least a source signal of the first and/or second analog signal Sx (Sxl and Sx2 as shown in Fig. 1) based on one or more signal parameters, included in the control program, describing the corresponding analog signal to be output by the signal source 110-10.
  • the signal generator 110-20 may be connected, with its input side, to e.g. a computer 200, as indicated in Fig. 2 by an arrow, which computer 200 is further described below with reference to Fig. 3.
  • the one or more signal parameters may be part of or may form the control program for the medical device 100 in accordance to which the signal source 110- 10 is controlled to provide the analog Signal Sx, Sxl, Sx2 based on the control program in order to cause the first and/or second current source 120, 130 to provide a corresponding electric current signal.
  • the control program controls the output of the electric current signal to be applied to the subject S
  • the control program may also be referred to as a therapy program.
  • the one or more parameters may comprise one or more of a signal shape or waveform, amplitude, frequency, and signal duration. These parameters may define a specific signal shape or waveform, which may also comprise one or more sequences of specific signal shapes or waveforms and/or one or more combinations of signal shapes or waveforms.
  • the specific signal shape or waveform may be sine, half sine, saw-tooth, triangle, line, DC, square, pulse, sine-segment, trapezoidal segment, Gaussian distribution, ECG, an arbitrary waveform, or the like.
  • the medical device may be configured to vary one or more parameters of the specific signal shape or waveform, such as duration, frequency, phase, duty cycle, pulse and/or amplitude.
  • Fig. 3 shows in a schematic block diagram another exemplary embodiment of the medical device 100.
  • Fig. 3 shows the medical device 100 from Fig. 1 and/or Fig. 2, but for better understanding shows more details of the components, units and/or circuits used.
  • the medical device 100 may comprise at least one first detection unit 160, 170, connected to an output side of the first current source 120 and/or second current source 130 as a first input and connected to receive the corresponding analog signal Sxl, Sx2 as a second input.
  • the first detection circuit 160, 170 may be configured to detect a voltage saturation at the output side of the medical device 100, particularly the output signal to the applicators 140, 150.
  • the medical device 100 comprises a first detection circuit 160 associated with the first current source 120, and a second detection circuit 170 associated with the second current source 130.
  • controller 110 may be further configured to control at least the signal source 110-10 to be disabled, if a value of the output side of the current source 120,
  • the detection circuit 160, 170 may comprise a comparator, e.g. an analog comparator, connected to the output side of the medical device 100, e.g. to the output side of the first and/or second current source 120, 130 to receive the corresponding electrical signal as a first input, and connected to the signal source 110-10 to receive the analog signal as a second input.
  • a comparator e.g. an analog comparator
  • the first detection circuit 160, 170 may be configured to compare both input signals with each other and to set an indicator value, e.g. a flag SAT-A, SAT-B, assigned to a corresponding voltage saturation status of the respective output, i.e. a voltage saturation status at the corresponding applicator 140, 150, if the output side of the current source 120, 130 approaches the analog signal above a threshold in a comparison of the two input signals. Therefore, the indicator value SAT-A, SAT-B set by the detection circuit 160, 170 indicates the voltage saturation status on the first and/or second applicator 140, 150, wherein the indicator value SAT-A, SAT-B is used, by the controller 110, to control the signal source 110-10.
  • an indicator value e.g. a flag SAT-A, SAT-B
  • the indicator value SAT-A, SAT-B may be provided to the signal generator 110-20 for further processing, wherein the signal generator is configured to control the signal source 110-10 on this basis. If the voltage saturation status is too high, i.e. reaches and/or exceeds the threshold, the indicator value SAT-A, SAT-B may be used to control the signal source 110-10 and/or the first and/or second current source 120, 130 to be automatically disabled.
  • the threshold may be set to be below the power supply limit of the medical device 100, and may particularly be set to 75 % to 95 %, preferably to about 95 %, of the output voltage of the medical device 100.
  • the medical device 100 may comprise at least one second detection circuit, connected to an output side of one of the current sources 120, 130 as a first input and connected to receive the analog signal as a second input, wherein the second detection circuit may be the same as the above detection circuit 160, 170 (as shown by way of example in Fig. 3), or may be an additional, further detection circuit configured at least similar to the above detection circuit 160, 170.
  • the controller 110 may be configured to control an output gain of the signal source 110-10, if a value of the output side of the corresponding current source 120,
  • the detection unitl60, 170 may generate a gain indicator AGC-A, AGC-B, and the controller 110 may generate a corresponding amplification constant Ky to control the gain of the analog signal Sx, Sxl, Sx2.
  • the medical device 100 e.g. the controller 110, comprises a calibration unitl 10-80, e.g. implemented as a calibration circuit, comprising at least one calibration resistor 110-81, and being selectively connectable to an output side of one of the first current source 120 and/or second current source 130 instead of the first applicator 140 and/or second applicator 150.
  • a calibration unitl 10-80 e.g. implemented as a calibration circuit, comprising at least one calibration resistor 110-81, and being selectively connectable to an output side of one of the first current source 120 and/or second current source 130 instead of the first applicator 140 and/or second applicator 150.
  • the controller 110 is further configured to generate, based on a value detected at the at least one calibration resistor 110-80, at least one calibration parameter Ky, Kz to be provided to the signal source 110-10 and/or the signal generator 110-20 to generate the analog signal Sx, Sxl, Sx2, based on the calibration parameter Ky, Kz.
  • the calibration parameter Ky may be referred to as an amplification constant
  • the calibration parameter Kz may be referred to as an offset constant.
  • the medical device 100 may comprise a measuring circuit 110-90, connected or selectively connectable to the subject S and configured to receive one or more measurement signals assigned to impedance of the subject S.
  • the controller 110 configured to control the signal source 110-10 and/or the first and/or second current source 120, 130 based on the measured impedance. Therefore, measurement of the measuring unit 110-90 may also be referred to as impedance feedback.
  • the medical device 100 may comprise, for example, at least one subject interface 110-91, e.g. a set of measuring applicators, to be brought into contact with the subject S and configured to receive the one or more measurement signals assigned to the impedance of the subject S.
  • the measurement signals may then be provided to the controller 110, which may generate e.g. the above amplification constant Ky based on the measured impedance, so as to adjust the analog signal Sx, Sxl, Sx2 on this basis.
  • the controller 110 may be further configured to determine a number of electric charges, e.g. in Coulomb (C), to be applied and/or applied to the subject S.
  • the controller 110 e.g. the signal generator 110-20, may comprise at least one electric charge determining unit, configured to determine an, preferably cumulated, electric charge to be applied or applied to the subject S.
  • the controller 110 may be further configured to control the signal source and/or the first and/or second current source 120, 130 based on the determined electric charge.
  • the electric charge determining means may be implemented in software only, in hardware only, or in a combination of hardware and software.
  • the software may record the current generated by the medical device over time and determine the amount of charge from this, e.g. by calculation.
  • the electric charge determining means may comprise at least one integrator, e.g. an integrating amplifier using an OP AMP, in order to provide a signal assigned to the number of electric charges.
  • the controller 110 may further comprise a data processing unit 110-40, connected at least to the signal generator 110-20 to e.g. control signal generation.
  • the data processing unit 110-40 may be connected to the measuring circuit 190 to e.g. receive measuring signals, such as impedance of the subject S.
  • the data processing unit 110-40 may be configured to process the control program, comprising the one or more signal parameters and/or signal sequences, i.e. the control program on the basis of which the electric current to be applied to the subject S can be generated and applied to via the first and/or second applicator 140, 150.
  • the data processing unit 110-40 may be further connected to a computer 200, such as a personal computer.
  • the computer 200 may run a suitable software application, which may be referred to as a therapy editor configured to provide a selection of signal parameters, signal shapes, waveforms etc. to order to provide the above control program, or therapy program.
  • the data processing unit 110-40 may be configured to receive the control program created on and provided by the computer 200, as indicated in Fig. 3 by an arrow. Further, the data processing unit 110-40 may be configured to process the control program, e.g. read and decrypt it, and may execute the control program by transferring the signal parameters to the signal generator 110-20 in a suitable data format, as indicated in Fig. 3 by an arrow. It may further be configured to read impedance feedback information from measuring unit 110-90, as indicated by an arrow, and may transfer it to the computer 200.
  • the data processing unit 110-40 may be configured to play music that is optionally attached to the control program. Also, the data processing unit 110-40 may be configured to process hardware board temperature measurements of the medical device 100, and to control one or more fans, in order to avoid over-temperature of the hardware board. Further, the data processing unit 110-40 may be configured to display system status of the medical device 100 and/or to detect malfunctioning.
  • the signal generator 110-20 will be described according to an exemplary implementation as used in at least some exemplary embodiments.
  • the signal generator 110-20 may comprise a data interface 110-21, e.g. a CPU interface, connected to the data processing unit 110-40, as indicated in Fig. 3 by an arrow.
  • the data interface 110-21 may be configured to use a suitable data protocol to exchange, i.e. to receive and/or transmit, data, such as e.g. the control program, a system status, an error message indicating any malfunctioning of the medical device 100, time slot parameters, etc., with the data processing unit 110-40.
  • a suitable data protocol to exchange, i.e. to receive and/or transmit, data, such as e.g. the control program, a system status, an error message indicating any malfunctioning of the medical device 100, time slot parameters, etc.
  • the signal generator 110-20 may comprise a memory 110-22, configured to store e.g. one or more digital samples used to generate a corresponding arbitrary signal. It is noted that the arbitrary samples may be processed sample by sample, not by the signal parameters as described herein.
  • the signal generator 110-20 may further comprise a clock 110-23, which may also be referred to as a real time marker, RTM. It may be used as an absolute clock that simultaneously applies a same time stamp marker in one or more buffers, in order to perform a time synchronization between signals generated and/or transmitted by the signal generator 110-20 and one or more feedback signals, e.g. received from the measuring unit 110-90.
  • a clock 110-23 which may also be referred to as a real time marker, RTM. It may be used as an absolute clock that simultaneously applies a same time stamp marker in one or more buffers, in order to perform a time synchronization between signals generated and/or transmitted by the signal generator 110-20 and one or more feedback signals, e.g. received from the measuring unit 110-90.
  • the signal generator 110-20 may comprise a signal parameter buffer 110-24, configured to store the signal parameters provided by the data processing unit 110-40 via the data interface 110-21.
  • the signal parameter buffer 110-24 may be connected to the data processing unit 110-40 and to other components in accordance with the arrows shown in Fig. 3.
  • the signal phase generator module (DPSG) generates a continuous dataflow of digital samples starting from a small amount of signal parameters, like frequency, amplitude, duty cycle, modulation formula, etc.
  • the signal generator 110-20 may further comprise a digital phase generator 110-25, implemented as e.g. an FPGA. It may be configured to utilize an address counter, which may also referred to as a phase register, and may point around 360° of a signal time- period and may select a corresponding sample amplitude stored in e.g. a lookup table.
  • the lookup table may be configured to store one or more digital amplitude samples for a given periodical signal, such as a sine wave, etc., or a semi-periodical shape.
  • the sample amplitude may be stored as a normalized value for each phase angle.
  • An output register may be used to synchronize a so-called “pipeline structure” and to store a digital normalized sample DNs of the generated signal.
  • the digital phase generator 110-25 may utilize the address counter containing the phase angles for a full signal period from 0° to 360°. Then, the output of the address counter is used to select the corresponding sample amplitude of the periodical signal stored in the lookup table. The output of the lookup table may be synchronized with the output register.
  • the signal generator 110-20 may further comprise a digital to analog converter 110-27, configured to convert the digital sample Ds into an analog sample Ax, which may also be referred to as a source signal to be provided to the signal source 110-10.
  • a digital to analog converter 110-27 configured to convert the digital sample Ds into an analog sample Ax, which may also be referred to as a source signal to be provided to the signal source 110-10.
  • the signal generator 110-20 may further comprise a calibration converter 110-28, configured to generate data to be used for an automatic calibration and/or test procedure using the calibration resistor 110-81.
  • the calibration converter 110-28 may be used to receive and/or process a voltage drop from the calibration resistor 110-81 to setup the zero-level and/or full-scale level of the medical device 100.
  • the calibration algorithm may be implemented within the digital phase generator 110-25.
  • the signal generator 110-20 may further comprise an offset digital to analog the digital converter 110-29, configured to convert a digital constant DKz assigned to an offset value to an analog value Kx in order to control the offset of an corresponding analog sample As.
  • the signal generator 110- may further comprise a logical unit 110-30, which may be implemented as e.g. a field-programmable gate array, FPGA.
  • Logical unit 110-30 may at least be connected to the data interface 110-21 and the memory 121-22 to receive their data for further processing. Further, the logical unit 110-30 may be connected to further components in accordance to the arrows shown in Fig. 3.
  • the logical unit 110-30 may set the clock 110-23 for each signal time slot at the time of signal generation, to have a precise time correlation with e.g. the feedback received from the measuring unit 110-90. From a functional perspective, the logical unit 110-30 may perform data and/or signal processing to implement functions, such as signal modulation, e.g.
  • the logical unit 110-30 may be configured to provide a response for one or more detecting and/or safety circuits, wherein this may be based on e.g. indicators AGC-A, B, for an automatic gain control, SAT-A, B, for a saturation-condition, and/or OPE-A, B, for an open applicator-condition.
  • the signal source 110-10 will be described according to an exemplary implementation as used in at least some exemplary embodiments.
  • the signal source 110-10 may further comprise a filter 110-11, e.g. a low pass filter, to provide spectral purity at least partly, low phase noise and an improved frequency response.
  • a filter 110-11 e.g. a low pass filter, to provide spectral purity at least partly, low phase noise and an improved frequency response.
  • the filter 110-11 is connected to receive the analog sample Ax from the digital to analog converter 110-27, and is configured to filter it.
  • the signal source 110-10 may further comprise an amplifier 110-12 connected to receive the output of the filter 110-11.
  • the signal source 110-10 may further comprise a summing unit 110-13, which may be implemented as e.g. an analogic adder circuit, configured to add the calibration offset constant Kx generated by the offset digital to analog the digital converter 110-29 in parallel with the analog sample Ax.
  • a summing unit 110-13 which may be implemented as e.g. an analogic adder circuit, configured to add the calibration offset constant Kx generated by the offset digital to analog the digital converter 110-29 in parallel with the analog sample Ax.
  • the signal source 110-10 may further comprise an amplifier 110-14, configured to provide the differential signal Sx, Sxl, Sx2 for the first and/or second current source 120, 130.
  • the measuring unit 110-90 will be described according to an exemplary implementation as used in at least some exemplary embodiments.
  • the measuring unit 110-90 may further comprise a logical unit 190-91, which may be implemented as an FPGA, configured to process the impedance feedback data obtained via an additional interface 110-92, which is connectable or connected to the subject S.
  • a logical unit 190-91 which may be implemented as an FPGA, configured to process the impedance feedback data obtained via an additional interface 110-92, which is connectable or connected to the subject S.
  • the measuring unit 110-90 may further comprise a clock 110-93, which may also be referred to as a real time marker, RTM. It may be used as an absolute clock that simultaneously applies a same time stamp marker in e.g. one or more buffers, in order to perform a time synchronization between signals generated and/or transmitted by the signal generator 110-20, c.f. the clock 110-23 and one or more feedback signals of the measuring circuit 110-90. Synchronization between clocks 110-23 and 110-93 is indicated in Fig. 3 by a dashed arrow.
  • the medical device 100 is described below in functional terms.
  • the medical device 100 may be functionally divided into functional units, distinguished in Fig. 3 by dashed rectangles.
  • the medical device 100 comprises as functional units the controller 110, the current sources 120, 130, and the applicators 140, 150, these functional units being distinguished in Fig. 3 by dashed rectangles.
  • the controller 110 generates and/or provides, by e.g. utilizing the signal generator 110-20, based on the above signal parameters received, a continuous stream of digital samples. Then, the controller 110 converts, e.g. by utilizing the signal generator 110-20 and/or the signal source 110-10, the digital samples in analog samples, i.e. the above analog signal Sx, Sxl, Sx2, configured to control the first and/or second current source 120, 130 to generate the electric current (signal) to be provided to the subject S via the first and/or second applicator 140, 150.
  • analog samples i.e. the above analog signal Sx, Sxl, Sx2
  • the analog sample Sx may then be provided, e.g. via the signal source 110-10, to the first and/or second current source 120, 130, for example as a kind of differential signal, which corresponds to the above analog signal Sx, Sxl, Sx2.
  • the detection unit 160, 170 may be operated in three operation modes, namely a normal operation mode, a voltage limitation mode, and an automatic calibration and/or test mode.
  • the normal operation mode may be active if the gain indicator AGC-A, AGC- B are not set to indicate to be active. This may, for example, be fulfilled if the output voltage is lower than the threshold, which may be expressed by Vout ⁇ threshold, wherein the threshold may be set to e.g. 75 % of Vcc, which is the power supply voltage.
  • the current amplitude may be applied in the required domain, such as 1 mA, 5 mA, 15 mA,
  • the voltage limitation mode may be active if the gain indicator AGC-A, B gain indicators AGC-A, AGC-B are set to be active. This may, for example, be fulfilled if the output voltage reaches and/or exceeds the threshold, which may be expressed by Vout > threshold, wherein the threshold may be set to 85 % of Vcc. If the impedance of the subject S is too high, the output voltage of the medical device 100 may become limited by the voltage power supply (Vcc) and the generated current may become distorted. This situation may be indicated by the gain indicator SAT- A, SAT-B being active, if the voltage level at the first and/or second applicator 140, 150 is greater than the threshold, e.g. 85 % of the power supply of the medical device 100.
  • the detection unit 160, 170 may then adjust the amplification coefficient DKy to avoid voltage saturation at the output side, namely at the first and/or second applicator 140, 150.
  • Ds DNs* DKyc + DKzc.
  • Fig. 4 shows in a schematic front view a therapy and/or diagnostic device 1, configured to stimulate a frequency domain of a pathogen present on or in the subject S by applying an electric current to the subject S, wherein the therapy device comprises at least one medical device 100 as described above.
  • the therapy device 1 may comprise a number of channels each comprising at least an arrangement of a signal source 111, a first current source 120 and a second current source 130 as described above.
  • Fig. 4 shows four channels, but this disclosure is not limited thereto, so that the therapy device 1 may comprise 2, 3, 4, 5, 6, 7, 8 or more channels.
  • the therapy device 1 may comprise a therapy editor, configured to create and/provide a selection of partial signals and/or signal parameters for assembling a signal sequence, and to provide a signal sequence generated based on the selection to a signal source of the medical device 100.
  • the one or more signal parameters may be provided with signal parameter information indicating over which application time the one or more signal parameters remain unchanged or to be changed.
  • the medical device utilizes only information of length of time with regard to changes or non-changes of the one or more signal parameters according to a predefined function, instead of also specifying the exact signal parameters for each time point.
  • time slot concept This mechanism may also referred to as time slot concept, in which the time slot is defined as the length of time that the one or more signal parameters remain unchanged or are changed according to a predefined function.
  • the time slot may be further defined or dimensioned with a length of time within which a reaction or response of the subject, i.e. the body or the substance, can be expected or even recognized, i.e. a reaction or response can be measured.
  • the time slot may have a length of time in the range of Milliseconds (ms), but is not limited thereto.
  • Fig. 5 shows in a flow chart a method for operating the above medical device 100 according to one or more of the exemplary embodiments described above.
  • the signal source 110-10 provides a first analog signal Sx, Sxl with a first phase and, simultaneously, a second analog signal Sx, Sx2 with a second phase phase-shifted to the first phase.
  • the first current source 120 connectable or connected to a subject S and having a first output impedance is operated by providing the first analog signal Sx, Sxl to an input side of the first current source 120 and generating, based on the received first analog signal, an electric current as output.
  • the second current source 130 connectable or connected to the subject S and having a second output impedance different to the first output impedance is operated by providing the second analog signal Sx, Sx2 to an input side of the second current source 130 and generating, based on the received second analog signal Sx, Sx2, an electric current as output.
  • the first and/or second impedance is controlled by adjusting the above resistance value of the at least one resistor of the resistor bridge 120-2, 130-2 of the first and/or second current source 120, 130 to cause the resistor bridge 120-2, 130-2 to be unbalanced.
  • the method may further comprise connecting a detection unit to an output side of one of the current sources 120, 130 as a first input and connected to receive the corresponding analog signal as a second input, and disabling, by the controller 110, at least the signal source 110-10, if a value of the output side of the current source 120, 130 approaches the corresponding analog signal above a threshold in a comparison of the two inputs.
  • the method may further comprise connecting, by the controller 110, a detection unit to an output side of one of the current sources 120, 130 as a first input and connected to receive the analog signal as a second input; and controlling, by the controller 110, an output gain of the signal source 110-10, if a value of the output side of the current source 120, 130 approaches the analog signal above a threshold in a comparison of the two inputs.
  • the method may further comprise selectively connecting, by a controller 110-10, the above calibration unit 110-80, comprising the at least one calibration resistor 110-81, to an output side of one of the first current source 120 and/or second current source 130 instead of the first applicator 140 and/or second applicator 150; and generating, by the controller 110, based on a value detected at the at least one calibration resistor, a calibration parameter to be provided to the signal source 110-10 to generate the analog signal.
  • the method may further comprise obtaining, by a controller 110, one or more signal parameters of at least a source signal of the corresponding analog signal by using signal parameter information indicating over which application time the one or more signal parameters remain unchanged or to be changed, and generating, by the controller 110, the source signal and/or the analog signal based on the signal parameter information.
  • a computer program or computer program element is provided that is characterized by being configured to execute the method steps of the method according to one of the preceding embodiments, on an appropriate system.
  • the computer program element might therefore be stored on the controller, e.g. a data processing unit, which might also be part of an embodiment.
  • This data processing unit may be configured to perform or induce performing of the steps of the method described above. Moreover, it may be configured to operate the components of the above described device and/or system.
  • the computing unit can be configured to operate automatically and/or to execute the orders of a user.
  • a computer program may be loaded into a working memory of a data processor.
  • the data processor may thus be equipped to carry out the method according to one of the preceding embodiments.
  • the computer program element might be able to provide all necessary steps to fulfill the procedure of an exemplary embodiment of the method as described above.
  • a computer readable medium such as a CD-ROM, USB stick or the like
  • the computer readable medium has a computer program element stored on it which computer program element is described by the preceding section.
  • a computer program may be stored and/or distributed on a suitable medium, such as an optical storage medium or a solid state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the internet or other wired or wireless telecommunication systems.
  • a suitable medium such as an optical storage medium or a solid state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the internet or other wired or wireless telecommunication systems.
  • the computer program may also be presented over a network like the World Wide Web and can be downloaded into the working memory of a data processor from such a network.
  • a medium for making a computer program element available for downloading is provided, which computer program element is arranged to perform a method according to one of the previously described embodiments of the invention.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un dispositif médical amélioré (100) configuré pour fournir un signal de courant électrique à un sujet, par exemple, à des fins thérapeutiques. Le dispositif médical (100) comprend : un dispositif de commande (110), comprenant une source de signal (111) configurée pour générer un premier signal analogique (Sx, Sx1) avec une première phase et, simultanément, un second signal analogique (Sx, Sx2) avec une seconde phase déphasée par rapport à la première phase ; une première source de courant commandée en tension (120), connectée à la source de signal (111) pour recevoir le premier signal analogique et pour générer, sur la base du premier signal analogique (Sx1) reçu, un courant électrique, et configurée pour fournir une première impédance de sortie ; une seconde source de courant commandée en tension (130) connectée à la source de signal (111) pour recevoir le second signal analogique et pour générer, sur la base du second signal analogique (Sx2) reçu, un courant électrique, et configurée pour fournir une seconde impédance de sortie différente de la première impédance de sortie ; un premier applicateur (140), conçu pour être mis en contact avec le sujet (S) et connecté à la première source de courant (120) ; et un second applicateur (150), conçu pour être mis en contact avec le sujet (S) et connecté à la seconde source de courant (130).
PCT/EP2021/059300 2021-04-09 2021-04-09 Dispositif médical et procédé de fonctionnement d'un dispositif médical WO2022214196A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130238048A1 (en) * 2012-03-09 2013-09-12 Enteromedics, Inc. Safety features for use in medical devices
EP3539609A1 (fr) * 2018-03-16 2019-09-18 Universität Ulm Commande polyvalente pour dispositif de stimulation neuronale
US20200155841A1 (en) * 2017-11-21 2020-05-21 Nikunj Arunkumar Bhagat Neuromuscular Stimulation Using Multistage Current Driver Circuit
WO2020190478A1 (fr) * 2018-08-31 2020-09-24 Avation Medical, Inc. Système, procédé, et appareil d'application de stimulation électrique transcutanée

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130238048A1 (en) * 2012-03-09 2013-09-12 Enteromedics, Inc. Safety features for use in medical devices
US20200155841A1 (en) * 2017-11-21 2020-05-21 Nikunj Arunkumar Bhagat Neuromuscular Stimulation Using Multistage Current Driver Circuit
EP3539609A1 (fr) * 2018-03-16 2019-09-18 Universität Ulm Commande polyvalente pour dispositif de stimulation neuronale
WO2020190478A1 (fr) * 2018-08-31 2020-09-24 Avation Medical, Inc. Système, procédé, et appareil d'application de stimulation électrique transcutanée

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