Therapy device for cell therapy or cell stimulation

Abstract

A therapeutic device for cell stimulation or cell therapy, comprising a housing (12) containing an electrode (1), a generator (3) for generating high-frequency voltage pulses, a processor unit (6) comprising a control, regulation, and calculation module, a storage unit (9), at least one operating element (5, 15), and a controllable modulator (4) by means of which the generator (3) can be controlled, wherein a voltage pulse sequence comprising a plurality of voltage pulses can be generated by means of the modulator (4), wherein the frequency and duration of the voltage pulses can be arbitrarily adjusted by means of the modulator (4), wherein the electrode (1), the generator (3), the processor unit (6), the storage unit (9), the operating element (5), and the modulator (4) are arranged in the housing (12), wherein the electrode (1) contains a glass body (27) which includes a cavity containing a gas, and wherein the electrode (1) has a first end (21).which can be coupled to the modulator (4), wherein the electrode comprises a second dome-shaped end (22), wherein the gas can be brought into the state of a non-thermal primary plasma by the voltage pulses transmitted to the electrode (1), wherein a secondary plasma can be generated by ionizing the air located in the vicinity of the second end (22) of the electrode (1).

Description

[0001] The present invention relates to a therapeutic device for cell therapy or cell stimulation according to the preamble of claim 1.

[0002] Therapeutic devices are known from the state of the art that utilize the technology of physiological electrical stimulation, also referred to in the literature as electrotherapy. Such devices are based on the principle of delivering electrical energy to the biological cell. This technology is used in medicine for so-called high-frequency therapy. An electric field generated by an RF generator is combined with a delivery unit for pulsed delivery of RF power to the cell to enable cell stimulation.

[0003] The application area of ​​the therapy device according to the invention lies in the field of wellness applications, fitness, cosmetics, pain reduction, wound healing, cell therapy or further cell stimulation for treatment in humans or animals.

[0004] Document DE 28 22 892 A1 shows an example of such a therapeutic device, namely a device for maintaining the negative potential of human, animal, and plant cells and / or for penetrating substances into the cells. A generator, controllable by a control circuit, produces high-frequency pulses of adjustable repetition frequency and duration, and an electrical circuit generates a DC voltage and a pulsed DC voltage for ionization and pulses of a specific shape and variable repetition frequency for faradization of the tissue to be treated. A therapy session is carried out over a predetermined time interval.

[0005] Although good results are achieved with this previously known therapeutic device with regard to its intended use, the following disadvantages arise for the users during operation: - The device is cumbersome to use during therapy because it only has a wired power supply. - The energy level is set via a manual control on the power supply unit, - the pulse frequency of the energy output can only be varied within a small range, namely within a range of 10 to 1000 Hz, - the emitted energy cannot be influenced in its signal form.

[0006] This limits the long-term success of the therapy, as local application of case-specific pulse shapes is not possible, resulting in an excessive number of recurring therapy sessions and / or a limited effect on the cells. The treatment head containing the electrode has a diameter of approximately 17 cm and a height of approximately 10 cm. An antenna is located within the treatment head, designed as an electrically insulating plastic plate with a circular conductive coating on its patient-facing surface. A spiral conductive coating is arranged on the opposite surface, with its ends connected to a tuning capacitor.

[0007] From EP 2 397 187 A1, a therapeutic device is known which is powered by a direct current source. This device generates a magnetic field to induce currents, thereby stimulating electrical signals in the body's nerve pathways, which can stimulate molecules, organs, or tissues of an organism. Due to the relatively high energy consumption associated with this method, efforts have been made to find ways to treat biological materials, particularly those containing living cells, locally with low energy consumption.

[0008] For example, according to DE103 24 926 B3, a pin-shaped electrode is provided for this purpose, which is connected to an AC high-voltage generator. The electrode has a rounded tip covered by a dielectric. The dielectric serves, on the one hand, to insulate the electrode 3, and on the other hand, it serves to dielectrically impede a gas discharge, which can be ignited by applying an AC high voltage to the electrode between the dielectric and the surface of a biological material, generating a cold plasma above the surface of the biological material. A ceramic, glass, or a plasma-resistant plastic can be used as the dielectric. The plasma contains free oxygen, which chemically acts on the biological material to kill unwanted microorganisms, bacteria, and degenerated tissue on the surface of the biological material.

[0009] German patent applications DE 10 2008 045 830 A1 and EP 2 163 143 B1 disclose a device for treating an object with a plasma, wherein the plasma is generated by means of an electrode and a counter electrode. A dielectric is arranged between the object to be treated and the electrode, so that a plasma is generated by means of a dielectrically hindered gas discharge, and this plasma is applied to the object to be treated. According to one embodiment, the electrode consists of an ionized gas, for example, a noble gas, inert gas, or gas mixture, wherein the ionized gas is generated by applying a high voltage greater than the breakdown voltage of the gas, which ionizes the gas and renders it a plasma. The gas thus becomes electrically conductive and can itself be used as an electrode.

[0010] Document US 5,866,082 A discloses a handheld device containing an electrode for generating a gas discharge in the air between the electrode and a body part being treated. The electrode is designed as a neon-filled glass body electrically coupled to a high-voltage transformer via a foil. The oxygen in the air between the electrode and the body part being treated is excited to ozone formation by sparking from the discharge of a capacitor located within the device. In the event of damage from breakage, the neon-filled glass body prevents electric shock by allowing the neon gas to escape, thus providing insulation from the transformer circuit.

[0011] Document DE 20 2020 104 271 U1 discloses a device for supporting wound healing treatment and / or the inactivation of microorganisms using pulsed electric fields. The device comprises an electrical energy storage device, a pulse generator, a transformer, and a treatment instrument. The treatment instrument contains an electrode immersed in a gas mixture. An electrical discharge results in a gas discharge. This device generates high-frequency electrical pulses with a frequency of 10 kHz to 100 kHz and a pulse repetition rate of 100 Hz to 400 Hz.

[0012] Document DE 10 2014 106 797 B3 discloses a device for mobile pain therapy. The device consists of a tabletop housing and a handpiece with an applicator. The tabletop housing contains a medium-frequency generator for producing a frequency of 32 kHz and a low-frequency generator for producing a frequency of 0.25 Hz. An alternating voltage of 32 kHz to 42 kHz is generated via a frequency switch and a driver and high-voltage generation unit, and an electric field of the corresponding frequency is generated by means of a neon-filled glass stirrer.

[0013] Based on this prior art, the invention aims to provide a therapeutic device that overcomes the disadvantages of the prior art. In particular, the invention aims to develop a therapeutic device that is easier to operate and whose pulse rate and / or energy output and / or signal shape can be individually tailored to the intended treatment or therapy by allowing the pulse rate and / or energy output and / or signal shape to be varied over a wide range.

[0014] The problem is solved by the features of claim 1. Advantageous embodiments of the therapy device are the subject of claims 2 to 17.

[0015] The therapeutic device for cell stimulation or cell therapy according to the invention comprises a housing containing an electrode, a generator for producing high-frequency voltage pulses, a processor unit comprising a control, regulation, and calculation module, a storage unit, at least one operating element, and a controllable modulator by means of which the generator can be controlled. A voltage pulse sequence comprising a plurality of voltage pulses can be generated by means of the modulator, wherein the frequency and duration of the voltage pulses can be adjusted as desired by means of the modulator. The electrode, the generator, the processor unit, the storage unit, the operating element, and the modulator are arranged in the housing. The electrode contains a glass body with a cavity containing a gas. The electrode has a first end that can be coupled to the modulator.The electrode comprises a second dome-shaped end, wherein the gas can be brought into the state of a non-thermal primary plasma by the voltage pulses transferred to the electrode, and wherein a secondary plasma can be generated by ionization of the air located in the vicinity of the second end of the electrode.

[0016] The gas can be a noble gas, such as helium, neon, or argon. The gas is located inside the glass body, meaning it is enclosed within the glass cavity. The gas is ionized by the application of voltage pulses, allowing a gas discharge from the electrode to the body part being treated. The gas forms the primary plasma, which is generated by applying the voltage, i.e., by transmitting the voltage pulse sequence. The glass body acts as a dielectric barrier. Using the primary plasma, a secondary plasma can be generated at the other end of the electrode, allowing the air to be ionized and thus electrically conductive, enabling coupling to the body part being treated.The high voltage generated by the primary plasma is greater than the breakdown voltage, resulting in the formation of free oxygen or ions in the air surrounding the end of the electrode. These ions interact with the surface of the body part being treated, thus stimulating cells. The body part itself acts as the cathode. Particularly when the air gap between the cathode and the first end of the glass body is less than 3 mm, a gas discharge occurs, forming the secondary plasma. According to one embodiment, the electrode can contain an antimicrobial coating.

[0017] Plasma is defined as a state of matter in which charged particles with positive and negative charges exist in a gas phase. The sum of the positive and negative charges is equal, so that within a given volume, the positive and negative charges cancel each other out, resulting in an overall neutral charge state. The plasma also contains atoms or molecules with a neutral charge, which, however, may exist in electronically, vibratorily, or rotationally excited states; these are therefore referred to as excited or reactive particles.

[0018] A non-thermal plasma is defined as a plasma in which the temperature describing the distribution of the kinetic energy of the plasma's electrons, hereinafter referred to as the electron temperature, is higher than the temperature describing the distribution of the kinetic energy of the plasma's ions, hereinafter referred to as the ion temperature. If the ion temperature is in the range of 25 °C to a maximum of 100 °C, the non-thermal plasma is called a cold plasma.

[0019] The therapy device according to one embodiment of the present invention thus comprises a direct atmospheric cold plasma therapy device. A secondary cold plasma is generated by means of the electrode containing the primary plasma. The generation of a secondary cold plasma has the advantage that no or at most only minimal heating of the body part to be treated occurs. The cells of the body part to be treated are therefore not exposed to any impermissible heat influence that could lead to damage to the cells or their components.

[0020] The therapy device reacts to touch by changing the plasma intensity, so its intensity varies depending on the holding position. The highest intensity was observed in the test series when the therapy device was held near the end opposite the electrode. Therefore, in the measurements described below, the therapy device was wrapped in grounded aluminum foil to eliminate any potential influence on the measurement results from manual manipulation of the device.

[0021] In one embodiment, the generator is designed as a Tesla coil. The voltage supplied by the energy storage unit is transformed to the generator's input voltage by means of the modulator. In one embodiment, the maximum frequency is in the range of 10 to 100 Hz. In another embodiment, the maximum voltage at the modulator's output is in the range of 8 V to 65 V. The modulator can include a transformer that transforms the voltage supplied by the energy storage unit to the input voltage required by the generator. In one embodiment, the voltage at the generator's output is in the range of 5 kV to 25 kV inclusive.

[0022] According to one embodiment, the frequency or amplitude can be adjusted using the modulator. The amplitude and / or frequency of the voltage can be modulated using the modulator. According to one embodiment, the frequency of the voltage pulse train is not constant, at least in certain sections. According to one embodiment, the amplitude of the voltage increases during a time interval t2-t1, the voltage is constant during a time interval t3-t2, and the voltage decreases during a time interval t4-t3, with the duration of the voltage pulse train corresponding to the time interval t4-t1.

[0023] In particular, the frequency can increase during the time interval t2-t1, remain constant during the time interval t3-t2, and decrease during the time interval t4-t3.

[0024] The modulator allows for the setting of any combination of voltages and frequencies. It also allows for the setting of any desired pulse sequence. This pulse sequence is transmitted to the generator, which then converts it into a pulse sequence with a correspondingly higher voltage. This high voltage is then applied to the electrode.

[0025] According to one embodiment, an energy storage unit arranged in the housing provides the energy supply for operating the therapy device, enabling wireless operation. The housing can contain a display element, which can be used to show therapy and operating data.

[0026] According to one embodiment, the electrode comprises a sensor by means of which the current or voltage emitted via the electrode can be detected as measured values, wherein the measured values ​​can be digitized into measurement data, wherein the measurement data can be stored in the storage unit, and wherein the emitted energy and / or the temporal profile of the energy emitted by the electrode can be determined by means of the calculation module of the processor unit.

[0027] In particular, the control module of the processor unit regulates the modulator based on the measurement data, specifically for maintaining a constant energy output and / or for controlling the signal waveform independently, allowing any desired signal waveform to be generated in the generator, for example, a combination of amplitude and frequency modulation. The measurement data can be used by the control module of the processor unit to control the course of therapy.

[0028] According to one embodiment, the measurement data in the processor unit can be linked with a timestamp, and the measurement data linked with the timestamp can be stored in the storage unit to store the therapy progress.

[0029] According to one embodiment, the housing can be designed as one of the poles of a capacitor for capacitive coupling.

[0030] The energy storage unit can be designed as a rechargeable element, for example, a lithium-ion cell or a supercapacitor. In particular, a single battery charge can be configured to operate the therapy device for a maximum duration of 50 minutes. The therapy device can operate continuously, especially for up to 25 minutes. The operating time can be extended by cooling the energy storage unit or by interrupting the operation of the therapy device for approximately 30 minutes.

[0031] According to one embodiment, the housing comprises an inner surface containing an electrically conductive or conductive area, for example, a conductive plastic or a plastic coated with an electrically conductive material. The outer surface of the housing is designed as an electrical insulator. In particular, the housing may contain or consist of a plastic. For example, the housing may contain or consist of ABS. Particularly for food applications, the housing may contain or consist of PLA (polylactic acid).

[0032] The therapy device features improved signal output, which can be selected or pre-programmed by the user depending on the type of therapy. The integrated energy storage unit, which enables wireless operation, significantly improves the device's handling.

[0033] According to the invention, this is made possible by at least one of the following features: - a variable signal waveform, for example a variable frequency of the high-frequency field emitted via an electrode, - the regulation of the intensity of the delivered energy, whereby typically the delivered power remains constant and independent of the position and / or type of electrodes, - Increased ease of use through an energy storage unit located in the housing, which has its own internal power supply and is operated by means of energy cells, typically by means of a battery.

[0034] Wireless application can be facilitated and improved in therapy by means of a new, previously unused physical principle. To enable the energy flow of the high-frequency field from the user to the treatment object, capacitive coupling is used, according to one embodiment. In this embodiment, the electrode is capacitively coupled to the user and connects them to the treatment object via the electrode. The user's body and the treatment object ensure potential equalization through the capacitive coupling.

[0035] The advantage of the invention with regard to the controllable, programmable energy output, adjustable in its signal shape, is that various forms of therapy can be optimized.

[0036] According to one exemplary therapy method, energy is delivered over a surface area via a variable pulse frequency of energy output, combined with modulation of the signal waveform. This influences, among other things, the concept of the skin effect, which is well-known to those skilled in the art. In this effect, the electrons, which reach the treatment object via the high-frequency voltage delivered by the electrode, are forced closer to the surface of the object. With lower amplitude and / or frequency modulation (AM / FM), the skin effect is reduced, resulting in more targeted penetration depth and duration of energy delivery.

[0037] The execution of a variable modulation is carried out by the user by operating controls of the therapy device and / or by a therapy device designed according to the type of therapy, which reads the required modulation from a storage unit.

[0038] In another embodiment, the energy output is measured by a sensor, for example by measuring a voltage and / or a current, and the measurement result is fed to the processor unit. The processor unit contains a control module by which different states can be regulated depending on the therapy method.

[0039] According to one embodiment, the energy output during modulation is modulated in such a way that the energy output follows a signal shape that can be selected or retrieved from the storage unit.

[0040] According to one embodiment, the energy output is stabilized regardless of the electrode used, the different coupling factor of the capacitive coupling, the wireless use during therapy, or the modulated signal shape.

[0041] In another embodiment, the measured values ​​determined by the sensor can be provided as a signal to the processor unit, which can then process the measured values ​​as measurement data. In particular, the calculation module can be used to calculate the units or measured quantities mentioned below. The units can optionally be displayed via a display element, output via an interface for information exchange, or stored in a memory unit.

[0042] The units can include at least one element from the following list: - total energy released in a specific time interval - Signal shape and modulation type (AM / FM) during therapy - Electrode placement and time interval of one or more interruptions - Regulation of an internal energy management system - Detection of faulty electrodes

[0043] Further calculations are conceivable that document and record the course of therapy for each patient. Furthermore, additional calculations incorporating external data imported via the interface are possible, which enhance and substantiate the success of the therapy. The processor unit can perform any type of calculation for this purpose; typically, these are regulatory and / or statistical calculations.

[0044] The results of the calculations can then be fed into the control module of the processor unit and influence the signal waveform and / or modulation. A learning effect for a later therapy session can be generated using therapy data from a previous session. This therapy data can be shared with other therapy devices via the information exchange interface, thus ensuring continuous quality improvement with every use of the therapy device according to the invention.

[0045] Capacitive coupling can be achieved by connecting the user and the treatment object to a conductive surface on the housing of the therapy device. For this purpose, the housing itself can be electrically conductive, meaning it has at least one electrically conductive surface, or it can have an internal conductive surface. The conductive surface itself can be a wire, a flat surface, or a three-dimensional object.

[0046] The energy storage unit can be powered via a charging system. In one embodiment, this charging system includes a connector and can draw the required energy from a commercially available charging station. In another possible embodiment, the energy storage unit is charged via an induction loop integrated into the housing. This induction loop forms the secondary coil of a transmission transformer. Energy can thus flow via the primary coil built into the charging station when the therapy device is within the charging station's field of influence. Such charging systems are now standardized and readily available in the electrical industry.

[0047] The invention is explained in more detail with reference to an exemplary embodiment, which is illustrated in the drawings. The drawings show: Fig. 1a: a schematic of a first embodiment of a therapy device, Fig. 1b: a diagram of a second embodiment of a therapy device, Fig. 1c: a schematic representation of the components for the second embodiment of the therapy device, Fig. 2 a simplified circuit diagram of a previously known therapeutic device, Fig. 3 a simplified circuit diagram of the therapy device according to Fig. 1a, Fig. 4a: a possible temporal tension progression of the in Fig. 2 previously known therapeutic devices shown, Fig. 4b: a possible temporal frequency profile of the in Fig. 2 previously known therapeutic devices shown, Fig. 5a: a possible temporal tension progression of the in Fig. 3 therapy device shown, Fig. 5b: a possible temporal frequency profile of the in Fig. 3 therapy device shown. Fig. 6a: a first component of a two-part housing for a therapy device according to Fig. 1b or Fig. 1c, Fig. 6b: a view of a first variant of an electrode for a therapy device according to Fig. 1b or Fig. 1c, Fig. 6c: a second component of a two-part housing for a therapy device according to Fig. 1b or Fig. 1c, Fig. 6d: a view of a second variant of an electrode, Fig. 6e: a view of a third variant of an electrode, Fig. 6f: a view of a therapy device according to Fig. 1b or Fig. 1c, Fig. 6g: a longitudinal section of a fourth variant of an electrode, Fig. 7: a partial section through the housing with the electrode arranged therein of a therapy device according to Fig. 1b or Fig. 1c, Fig. 8a: a radial section through the first sub-element of the housing according to Fig. 6a, Fig. 8b: a radial section through the second sub-element of the housing according to Fig. 6c, Fig. 9: a measuring setup for measuring a patient leakage current, Fig. 10a a diagram of the patient leakage current as a function of the distance of a first therapy device from the cathode, Fig. 10b a diagram of the patient leakage current as a function of the distance of a second therapy device from the cathode, Fig. 10c a diagram of the patient leakage current as a function of the distance of a third therapy device from the cathode, Fig. 10d the temperature profile as a function of the distance of the electrode from the cathode for the second therapy device, Fig. 11 a measuring arrangement for determining the composition of a secondary plasma generated by means of the therapy device, Fig. 12a a diagram of the composition of the secondary plasma of the first therapy device, Fig. 12b a diagram of the composition of the secondary plasma of the second therapy device, Fig. 12c a diagram of the composition of the secondary plasma of the second therapy device, Fig. 13 a spectrum of the third therapy device compared with the first therapy device, Fig. 14 a measuring arrangement for determining the reactive species formed during discharge, Fig. 15 an exemplary spectrum of the first therapy device determined by means of FTIR spectroscopy, Fig. 16 a representation of the measured current intensity at the HI setting. Fig. 17a the pH value depending on the treatment duration for a first therapy device with the LO setting, Fig. 17b the pH value depending on the treatment duration for the first therapy device with the HI setting, Fig. 17c the pH value depending on the treatment duration for the second therapy device in water, Fig. 17d the pH value depending on the treatment duration for the second therapy device in NaCl, Fig. 17e the pH value as a function of the treatment duration for a first electrode of the third therapy device in water, Fig. 17f the pH value as a function of the treatment duration for a second electrode of the third therapy device in water, Fig. 18a the concentration of H2O2 as a function of the treatment duration for the first therapy device, Fig. 18b the concentration of H2O2 in water for the second therapy device, Fig. 18c the concentration of H2O2 in NaCl for the second therapy device, Fig. 18d the concentration of H2O2 in water for the first electrode of the third therapy device, Fig. 18e the concentration of H2O2 in water for the second electrode of the third therapy device, Fig. 19 the concentrations of NO2 - in H2O and NaCl depending on the treatment duration for the first therapy device, Fig. 20 results of an MTT test to determine cytotoxicity for the first therapy device, Fig. 21 Results of an MTT test to determine cytotoxicity for the second therapy device, Fig. 22a Results of an MTT test to determine the cytotoxicity of the first electrode of the third therapy device, Fig. 22b Results of an MTT test to determine the cytotoxicity for the second electrode of the third therapy device, Fig. 23 an illustration of the agar plates for an inhibition zone test for the LSE electrode for the bacterium Staphylococcus aureus, Fig. 24 a bar chart of the results of the inhibition zone test for the bacterium Staphylococcus aureus for the LSE electrode, Fig. 25 an illustration of the agar plates for an inhibition zone test for the EWC electrode of the first therapy device for the bacterium Staphylococcus aureus, Fig. 26 an illustration of the agar plates for an inhibition zone test for the EWC electrode of the first therapy device for the bacterium Staphylococcus epidermidis, Fig. 27 an illustration of the agar plates for an inhibition zone test for the EWC electrode of the first therapy device for the bacterium Escherichia coli, Fig. 28 an illustration of the agar plates for an inhibition zone test for the EWC electrode of the first therapy device for the bacterium Pseudomonas aeruginosa, Fig. 29 an illustration of the agar plates for an inhibition zone test for the EWC electrode of the first therapy device for the yeast Candida albicans, Fig. 30 a bar chart of the results of the inhibition zone tests for all microorganisms for the EWC electrode of the first therapy device, Fig. 31 an illustration of the agar plates for an inhibition zone test for the EWC electrode of the second therapy device for the bacterium Staphylococcus aureus, Fig. 32 an illustration of the agar plates for an inhibition zone test for the EWC electrode of the second therapy device for the bacterium Staphylococcus epidermidis, Fig. 33 An illustration of the agar plates for an inhibition zone test for the EWC electrode of the second therapy device for the bacterium Escherichia coli, Fig. 34 An illustration of the agar plates for an inhibition zone test for the EWC electrode of the second therapy device for the bacterium Pseudomonas aeruginosa, Fig. 35 an illustration of the agar plates for an inhibition zone test for the EWC electrode of the second therapy device for the yeast Candida albicans, Fig. 36 a bar chart of the results of the inhibition zone tests for all microorganisms for the EWC electrode of the second therapy device, Fig. 37 an illustration of the agar plates for a zone of inhibition test for the third therapy device for the bacterium Staphylococcus aureus, Fig. 38 an illustration of the agar plates for a zone of inhibition test for the third therapy device for the bacterium Staphylococcus epidermidis, Fig. 39 An illustration of the agar plates for a zone of inhibition test for the third therapy device for the bacterium Escherichia coli, Fig. 40 an illustration of the agar plates for a zone of inhibition test for the third therapy device for the bacterium Pseudomonas aeruginosa, Fig. 41 an illustration of the agar plates for a zone of inhibition test for the third therapy device for the yeast Candida albicans, Fig. 42 a bar chart of the results of the inhibition zone tests for all microorganisms for the third therapy device.

[0048] Fig. Figure 1a schematically shows a first embodiment of a therapy device for cell therapy, comprising an electrode 1, a generator 3 for generating high-frequency pulses, a processor unit 6 comprising a control, regulation and calculation module, a storage element 9 and operating elements 5.

[0049] The therapy device can include at least one interface 8 for information exchange.

[0050] The therapy device further comprises a storage unit 9 and a controllable modulator 4, which controls the generator 3. The energy supply for operating the therapy device is provided by an internal energy storage unit 10.

[0051] The housing 12 can contain at least one display element 7, by means of which therapy and operating data in particular can be displayed.

[0052] Furthermore, the therapy device includes a sensor 2, which measures the voltage and / or current delivered via electrode 1. The energy delivered via electrode 1 can be determined from the measured voltage or current. The sensor thus records the current and / or voltage delivered via electrode 1 as measured values. These measured values ​​are digitized and stored as measurement data in the storage unit 9. The delivered energy can be determined from the measurement data using the calculation module of the processor unit 6. The temporal profile of the energy delivered by electrode 1 can be determined from the measurement data for current and / or voltage stored in the storage unit 9 with a timestamp, using the calculation module of the processor unit 6.Alternatively, the measured voltages and / or currents can be recorded by a recording device and converted into measurement data, so that the time course of the energy delivered by electrode 1 can be determined from the recorded measurement data for the voltage and the current.

[0053] All components of the therapy device are arranged in a housing 12.

[0054] In particular, the housing 12 and / or the generator 3 can be designed such that the housing or the generator forms one pole of a capacitor which enables capacitive coupling.

[0055] According to one embodiment, the therapy and operating data from storage unit 9 are designed to be read and writeable. The data stored in storage unit 9 can be used to influence the course of therapy.

[0056] According to one embodiment, the therapy and operating data, taking into account the measured values ​​from sensor 2, which may be stored as data in the memory unit, can be calculated and processed into control instructions in the processor unit 6. These control instructions can then be used to control the modulator 4.

[0057] The control of modulator 4 can be carried out in such a way that the energy output is constant and independent of the signal shape.

[0058] In particular, the modulator 4 can be controlled in such a way that any signal shape is generated in the generator 3; typically, a combination of amplitude and frequency modulation can be used.

[0059] According to one embodiment, the housing 12 contains an electrically conductive or conductive surface, for example a conductive plastic or a plastic coated with an electrically conductive material.

[0060] According to one embodiment, the energy storage unit 10 can be designed as a rechargeable element, typically as a lithium-ion element or as supercapacitance.

[0061] The energy delivered via electrode 1 can be used for cell stimulation or cell therapy.

[0062] Fig. Figure 1b shows a second embodiment of a therapy device 20, wherein the same reference numerals have been used for identical or equivalently acting components as in Fig. 1a.

[0063] The therapy device 20 comprises an electrode 1, a generator 3 for generating high-frequency pulses, a processor unit 6 comprising a control, regulation, and calculation module and operating elements 5, 15, as well as an energy storage unit 10. The electrode 1, the generator 3, the processor unit 6, the operating elements 5, 15, and the energy storage unit 10 are housed in a common casing 12 when assembled, which in Fig. 1b is schematically represented as a system boundary.

[0064] The energy supply for operating the therapy device 20 is provided by an energy storage unit 10, which is also installed in the housing 12. The energy storage unit 10 can, in particular, contain a rechargeable battery. According to one embodiment, the energy storage unit 10 can contain a lithium-ion battery or a supercapacitor. The energy storage unit 10 can be charged by means of a charger 16, which is known to those skilled in the art and is therefore not specified in detail in this illustration.

[0065] According to the present embodiment, the operating elements 5, 15 are rotatably arranged in the housing 12, as shown in the schematic representation according to Fig. 1c is visible. The duration of each pulse can be set using the control element 5. The amplitude of the pulse can be set using the control element 15. According to the present embodiment, a scale is provided on each of the control elements 5 and 15, which can be used to display the set therapy and operating data. In addition, the housing 12 can contain an optical display element, for example, an LED light.

[0066] Furthermore, the therapy device includes a sensor 2, which measures the voltage and / or current delivered via electrode 1. The energy delivered via electrode 1 can be determined from the measured voltage or current. The sensor thus records the current and / or voltage delivered via electrode 1 as measured values. These measured values ​​are digitized and stored as measurement data in the storage unit 9. The delivered energy can be determined from the measurement data using the calculation module of the processor unit 6. The temporal profile of the energy delivered by electrode 1 can be determined from the measurement data for current and / or voltage stored in the storage unit 9 with a timestamp, using the calculation module of the processor unit 6.Alternatively, the measured voltages and / or currents can be recorded by a recording device and converted into measurement data, so that the time course of the energy delivered by electrode 1 can be determined from the recorded measurement data for the voltage and the current.

[0067] According to one embodiment, the therapy and operating data, taking into account the measured values ​​from sensor 2, which may be stored as data in the memory unit, can be calculated and processed into control instructions in the processor unit 6. These control instructions can then be used to control the modulator 4.

[0068] The modulator 4 can be controlled, in particular, such that the energy output is constant and independent of the signal waveform. Specifically, the modulator 4 can be controlled such that any desired signal waveform is generated within it; typically, a combination of amplitude and frequency modulation is possible. According to one embodiment, the modulator 4 can be configured as a transformer. This transformer serves to generate the electrical voltage required for ionizing the gas in the electrode. The voltage of the modulator 4 can range from 8 V to 65 V.

[0069] The input voltage of generator 3 can range from 8 V to 65 V. The output voltage of modulator 4 is transformed by generator 3, for example, to an electrical voltage in the range of 5 kV to 25 kV inclusive. The generator thus contains a high-voltage transformer. According to one embodiment, the high-voltage transformer is designed as a Tesla coil. The high-voltage transformer comprises a primary winding to receive the power supplied by the modulator. A primary winding voltage is therefore present at the primary winding, for example, in the range of 8 V to 65 V. The high-voltage transformer contains a secondary winding at which a secondary winding voltage is available. This secondary winding voltage is higher than the primary winding voltage.The secondary winding of the high-voltage transformer, designed as a Tesla coil, is arranged concentrically to the primary winding, allowing for a particularly space-saving design of the high-voltage transformer. The secondary winding voltage can be at least 100 times greater than the primary winding voltage.

[0070] In particular, the secondary winding voltage can be 300 to 1000 times higher than the primary winding voltage. For example, if the primary winding voltage is 65 V, the secondary winding voltage is 25 kV. According to this embodiment, the secondary winding voltage is 385 times higher than the primary winding voltage.

[0071] The voltage pulses generated by the modulator 4 are thus transformed into high-voltage pulses by the generator 3 and supplied to the electrode 1, which contains an anode 45. The anode 45 is located inside a glass body 27. The anode contains a material from which electrical charge carriers, in particular electrons and ions, can be released when a high voltage is applied. These electrical charge carriers enter the gas-filled glass body 27. The positively charged electrical charge carriers move towards the cathode 55. According to this embodiment, the cathode 55 is formed by the surface being treated, which is shown schematically. The negatively charged electrical charge carriers move towards the anode. If the negatively charged charge carriers are sufficiently accelerated, they can release further charge carriers upon impact with the anode, which then enter the gas interior.When electrons collide with gas molecules, ions are generated, which move towards the cathode as positive charge carriers. If the applied voltage is in the range of 5 to 25 kV inclusive, the number of charge carriers in the gas increases exponentially, leading to ionization of the gas and thus the formation of a plasma. In this case, it is a so-called cold plasma, since the electrons are not generated by thermal emission, but rather as secondary electrons resulting from the contact of charge carriers with the anode material.

[0072] According to the invention, the cathode 55 is located outside the glass body 27; therefore, the electric field generated in the electrode 1 also acts on charge carriers in the air, such as oxygen. The second end 22 of the electrode 1 acts as a dielectric barrier. In particular, oxygen molecules can be ionized by the electric field, forming a so-called secondary plasma. Especially when the cathode is located at a distance of up to 2 mm from the second end 22 of the electrode 1, a dielectrically hindered discharge can be ignited in the airspace.

[0073] The therapy device 20 functions like a capacitor, the first pole of which is formed by the housing 12 and the second pole by the treated area of ​​the body. The first pole is formed by the electrode 1, which contains the anode 45. The second pole is formed by the cathode 55. According to the present embodiment, the housing 12, which contains the electrode 1, forms one of the poles of the capacitor. The person holding the housing 12 during the therapy brings it into contact with the opposite pole of this capacitor, the area of ​​the patient's body being treated, or at least brings it close enough to allow the formation of a secondary plasma.

[0074] Fig. Figure 1c shows an exploded view of a housing 12 in which the electrode 1, the generator 3, the modulator 4, the processor unit 5, and the energy storage unit 10 are arranged. The housing 12 contains the previously described operating elements 5 and 15.

[0075] According to one embodiment, the housing 12 contains an electrically conductive or conductive surface, for example a conductive plastic or a plastic coated with an electrically conductive material.

[0076] The energy delivered via electrode 1 can be used for cell stimulation or cell therapy.

[0077] Fig. Figure 2 shows a simplified diagram of the therapy device according to EP 2397187 A1. This previously known therapy device is powered by a direct current source 110, for example, a battery. A current flows from the capacitor 104 to the coil 103, which induces an electromagnetic field when the connection to the direct current source 110 is interrupted by means of the switch 107. According to this embodiment, the coil is the potential-generating element for an electrode 101. A potential difference is generated by the coil. Due to the potential difference, an electrical voltage is present at the electrode 101. This electrical voltage is transmitted to the patient via the electrode 101, which is in contact with the patient. A diode 106 prevents the backflow of current into the battery circuit. When the switch 107 is closed, the capacitor 104 can again be recharged by the battery 110.Since the coil 103 acts as an electrical resistor in this circuit, the capacitor 104 is charged, and there is no potential difference at the electrode 101. By periodically opening and closing the switch 107, the potential difference at the electrode 101 can fluctuate between zero and the maximum value achievable by the built-in coil 103, thus enabling pulsed operation. Consequently, a pulsed electrical voltage is generated, which can be used for therapeutic purposes. The direction of the current flowing to the capacitor when the switch 107 is open is the opposite of the direction of flow when the switch 107 is closed. A diode 106 prevents the current from flowing back into the battery circuit when the switch 107 is closed. The frequency of the pulsed electrical voltage is therefore determined by the switching frequency of the switch 107.This therapy device can generate a pulsed voltage of variable frequency; however, the amplitude of the voltage is predetermined by the coil 103 used. The leakage resistor 105, connected in parallel to the capacitor 104, is a component for preventing electric shocks when the therapy device is touched after the DC power source has been switched off. The capacitor 104 can be discharged via the leakage resistor 105.

[0078] Fig. Figure 3 shows a simplified circuit diagram of the therapy device according to the invention. The therapy device comprises a generator 3, which is designed as a coil, by means of which a pulsed voltage can be generated and directed onto the patient's body part to be treated by means of the electrode 1. The pulse frequency and pulse duration can be set by means of the modulator 4, which, according to the present embodiment, is designed as a switch. When the switch is closed, the capacitor 13 can discharge through the coil. That is, an electrical voltage is applied to the coil, so that an electromagnetic field is created, which produces the desired therapeutic effect on the body cells located within its area. The current can be adjusted by means of the potentiometer 11. This allows the amplitude of the voltage applied to the coil to be changed.

[0079] When the switch is in the open position, as shown in the present illustration, no current can flow through the coil; that is, the coil does not generate an electromagnetic field. The capacitor 14 can be charged by the energy storage unit 10, that is, by the DC power source according to this embodiment. The leakage resistor 14, connected in parallel to the capacitor 13, is, as in the prior art, a component for preventing electric shocks upon contact with the therapy device after the DC power source has been switched off. The capacitor 13 can be safely discharged via the leakage resistor 14.

[0080] Fig. 4a shows a possible time-dependent voltage profile of the in Fig. 2 previously known therapeutic devices shown. The graphic representation in Fig. Figure 4a shows a time course of the electrical voltage; that is, the ordinate represents the electrical voltage in volts, and the abscissa represents time. Voltage pulses can be generated using the known therapeutic device by briefly opening and then closing switch 107, so that the coil is energized while the switch is closed, but the current supply is interrupted while the switch is open. For example, the switch can be closed for approximately 1 ms, then opened for 1 ms. While the switch is closed, a voltage is built up by the current flowing through the coil. While the switch is open, no voltage is generated. That is, the duration for which the switch is closed corresponds to one voltage pulse. If the switch is opened and closed several times, a plurality of voltage pulses can be generated, which in Fig. Figure 4a shows an example of five voltage pulses. The switch can then be opened for an extended period. During this time, no voltage is generated because no current can flow through the coil. This period can be of any length. If the treatment requires it, a further sequence of voltage pulses can be generated by repeatedly opening and closing the switch for short periods.

[0081] Fig. 4b shows a possible temporal frequency profile of the in Fig. 2. A previously known therapeutic device is shown. The frequency in Hertz is plotted on the ordinate, and the time on the abscissa. Each sequence of voltage pulses in Fig. 4a corresponds to a frequency greater than zero, which in Fig. Figure 4b is shown as a column. As long as switch 107 is open, no voltage is generated because no current flows through the coil. Therefore, the frequency is zero Hertz during this period.

[0082] Fig. 5a shows a possible time-dependent voltage profile of the in Fig. 3. Therapy device shown according to an embodiment of the invention. The graphic representation in Fig. Figure 5a shows a time course of the electrical voltage; that is, the voltage in volts is plotted on the ordinate, and time on the abscissa. Voltage pulses can be generated using the therapy device by actuating modulator 4, for example, by briefly opening and then closing the switch. This ensures that the coil is energized while the switch is closed, but the current supply is interrupted while the switch is open. For example, the switch can be closed for approximately 1 ms, then opened for 1 ms. Alternatively, the switch can be opened for 0.1 s and then closed for 0.1 s. The range in which the opening time can vary is, in particular, 0.001 s to 0.1 s. The range in which the closing time can vary is, in particular, 0.001 s to 0.1 s.As long as the switch is closed, a voltage is built up by the current flowing through the coil. As long as the switch is open, no voltage is generated. This means that the time the switch is closed corresponds to a voltage pulse. If the switch is opened and closed repeatedly, a multiple of voltage pulses can be generated, which is described as... Fig. Figure 5a shows an example of 13 voltage pulses forming a voltage pulse sequence. The switch can then be opened for an extended period. During this period, no voltage is generated because no current can flow through the coil. This period can be of any length. For example, the period can range from 0.1 s to 10 s. In particular, the period can range from 0.1 s to 1 s. According to one embodiment, the period can be 0.1 s. If the process requires it, at least one further voltage pulse sequence can be generated by repeatedly opening and closing the switch for short periods. Fig. Figure 5a shows two voltage pulse sequences as examples.

[0083] For each of the in Fig. In the voltage pulse sequences of n voltage pulses shown in Figure 5a, the voltage of each voltage pulse increases during a time interval t2-t1 or t6-t5, the voltage of each voltage pulse remains constant during a time interval t3-t2 or t7-t6, and the voltage of each voltage pulse decreases during a time interval t4-t3 or t8-t7. The mean pulse duration tm of n voltage pulses corresponds to (t4-t1) / 2n if the time interval during which the switch is on corresponds to the time interval during which the switch is off.

[0084] If the duration ts of each of the n voltage pulses differs from the duration tp of each of the pauses between the voltage pulses, the mean pulse duration tm of n voltage pulses and m pauses can be determined as follows. The duration of the voltage pulse sequence D corresponds to the sum of all tsi and the sum of all tpi. tsi denotes the i-th time intervals of each of the voltage pulses 1 to n. tsi denotes the i-th time intervals of each of the pauses from 1 to m. For example, the i-th voltage pulse extends over a time interval tsi, and the (i+1)th voltage pulse over a time interval ts(i+1). Similarly, the i-th pause has a time interval tpi, and the (i+1)th pause has a time interval tp(i+1).To obtain the mean pulse duration tm, the duration of the voltage pulse sequence D is divided by the number (n+m) of voltage pulses and pause times, where n corresponds to the number of voltage pulses and m to the number of pause times of a sequence of voltage pulses.

[0085] According to the present embodiment, the amplitude of the voltage pulses therefore varies. Fig. 5a The amplitude of the voltage pulses increases within the time interval t2-t1. The amplitude of the voltage pulses remains constant during the time interval t3-t2. The amplitude of the voltage pulses decreases during the time interval t4-t3.

[0086] Fig. 5b shows a possible temporal frequency profile of the in Fig. 3. Therapy device shown according to an embodiment of the invention. The frequency in Hertz is shown on the ordinate, the time on the abscissa. Each sequence of voltage pulses in Fig. 5a corresponds to a frequency greater than zero, which in Fig. Figure 5b is represented as a trapezoidal shape. As long as the switch is open, no voltage is generated because no current flows through the coil. Therefore, the frequency during this time interval between two adjacent voltage pulse sequences is zero Hertz. According to Fig. 5b The frequency of the voltage pulses in the first voltage pulse sequence increases within the time interval t2-t1. The frequency of the voltage pulses remains constant during the time interval t3-t2. The frequency of the voltage pulses decreases during the time interval t4-t3. The frequency of the voltage pulses in the second voltage pulse sequence also increases within the time interval t6-t5. The frequency of the voltage pulses remains constant during the time interval t7-t6. The frequency of the voltage pulses decreases during the time interval t8-t7.

[0087] The representation according to Fig. 5a does not correlate in this respect with the representation according to Fig. 5b. According to Fig. 5a The duration of the voltage pulses remains constant, therefore the corresponding frequency would be in one of the Fig. 5b corresponding graphical representation constant.

[0088] According to the in Fig. In the variant shown in 5b, the time interval tsi decreases within the time interval t2-t1, the time interval tsi is constant within the time interval t3-t2, and the time interval tsi increases within the time interval t4-t3.

[0089] For the in Fig. In the second voltage pulse sequence shown in Figure 5b, the time interval tsi decreases within the time interval t6-t5, the time interval tsi is constant within the time interval t7-t6. The time interval tsi increases within the time interval t8-t7.

[0090] Fig. Figure 6a shows a first partial element 17 of a two-part housing 12 of a therapy device 20.

[0091] Fig. Figure 6b shows an embodiment of a first variant for an electrode 1 located in a housing 12. The electrode 1 can thus be removed from the housing 12 and, if necessary, replaced by another electrode. The electrode 1 comprises a first subsection 23 and a second subsection 24, wherein the first subsection 23 has a length L1 and the second subsection 24 has a second length L2. The first subsection 23 extends from a first end 21 to a stop element 25. The second subsection 24 extends from the stop element 25 to a second end 22 of the electrode 1.

[0092] Fig. Figure 6c shows a second sub-element 18 of the two-part housing 12.

[0093] Fig. Figure 6d shows an embodiment of a second variant of an electrode 1. According to the Fig. In the variant shown in 6d, the length L3 of the second subsection 24 is greater than the length L2 of the corresponding second subsection 24 according to Fig. 6b. The length L1 of the first subsection corresponds to the length L1 according to Fig. 6b, since electrode 1 according to the second variant can be installed in the housing 12 instead of electrode 1 according to the first variant.

[0094] Fig. Figure 6e shows an embodiment of a third variant of an electrode 1. According to the Fig. In the variant shown in 6d, the length L4 of the second subsection 24 is greater than the length L2 of the corresponding second subsection 24 according to Fig. 6b, however, is smaller than the length L3 of the second subsection 24 of the electrode according to the second variant. This embodiment also only shows an exemplary embodiment. Of course, the length L4 can differ from the present illustration. The length L1 of the first subsection corresponds to the length L1 according to Fig. 6b, since the electrode 1 according to the third variant can be installed in the housing 12 instead of the electrode 1 according to the first variant. The second end 22 of this electrode 1 is not designed as a rounded tip, as shown in the preceding embodiments, but has a flange-like end. This electrode 1 is used when a gas discharge is to be applied over a larger area onto an object to be treated, as shown in the present illustration, over the circular area.

[0095] Fig. Figure 6f shows the therapy device 20 containing a housing according to Fig. 6a and Fig. 6c and an electrode 1 according to one of the in Fig. 6b, Fig. 6d, Fig. The variants shown in Figure 6e comprise a two-part housing 12 in which an electrode 1 can be arranged. The electrode 1 is replaceable. To replace the electrode 1, the first sub-element 17 of the housing 12 and the second sub-element 18 of the housing 12 can be separated from each other.

[0096] Fig. Figure 6g shows an embodiment of a fourth variant of an electrode 1, which is depicted in longitudinal section. The electrode 1 has a first end 21, which is designed for coupling with the modulator 4. The electrode 1 has a second end 22, which is designed as a rounded tip. The electrode 1 comprises a glass body 27, which is arranged in a retaining element 26 such that at least the second end 22 projects beyond the retaining element 26. In the assembled state, the retaining element 26 extends within the housing to the stop element 25. According to this embodiment, the stop element 25 is part of a conical end section 28. Inside the conical end section 28 is a bearing element 29, which serves to support the glass body 27 in the retaining element 26.

[0097] The glass body 27 contains a conical section 30, which extends from the second end 22 to the conical end section 28. The diameter of the conical section can increase continuously from the second end 22 to the conical end section 28. In the region of the conical end section 28, the glass body 27 contains a constriction 31, meaning that its diameter decreases in the region of the conical end section 28, only to widen again to a larger diameter in the central section 38 adjoining the conical end section 28. The outer diameter of the glass body 27 in the central section 38 can essentially correspond to the inner diameter of the central section 38 of the retaining element 26. The region of the glass body 27, which is essentially cylindrical, will hereinafter be referred to as the central region 32.

[0098] The central section 32 is adjoined by an end section 33 of the glass body 27, which includes a groove 34 and a dome element 36 with a point 37. A sealing element 35 is located in the groove 34, which rests against the inner wall of the central section 38 of the retaining element 26.

[0099] A pin element 40 extends from the tip 37 to the first end 21 of the electrode. The pin element 40 is connected to a conductor element 39, which has electrical conductivity, so that the voltage pulses generated by the modulator 4 and transformed to high voltage by the generator 3 can be transmitted into the glass body 27 and there to the gas contained within. The pin element 40 is connected to the conductor element 39, which extends from the pin element 40 to an arc element 41. The conductor element 39 can, for example, be designed as a wire or as a sleeve. According to this embodiment, the arc element 41 is a component of the conductor element 39. The pin element 40 and the conductor element 39 are electrically insulated from the environment by the retaining element 26. The retaining element 26 contains or consists of a non-electrically conductive material, for example, a plastic.The conductor element 39 penetrates the shell of the glass body 27 and leads into the interior of the glass body 27 to an anode 45 located there.

[0100] Furthermore, the pin element 40 is positioned and centered in its axial position by a positioning element 43, ensuring that the axis of the pin element 40 is aligned with the central axis of the glass body 27, i.e., the pin element 40 is arranged coaxially with the glass body 27. The sleeve 39 is located inside the end section 44 of the retaining element 26, which adjoins the groove 26. An annular cavity is formed between the sleeve 39 and the end section 44.

[0101] Fig. Figure 7 shows a partial section of a therapy device 20 in which an electrode is inserted according to Fig. The electrode 1 is held in the housing 12 by means of a snap-fit ​​connection 19. The end of the housing 12 is positioned on the stop element 25, so that the electrode 1 is held in the desired position in the housing.

[0102] In Fig. Figure 7 is also an embodiment for the electrical coupling of the electrode 1 with the generator 3, which can be designed, in particular, as a Tesla coil. The generator 3 includes a connection element 56, which is in contact with the pin element 40. The pin element 40 contains an electrically conductive material, so that the high voltage generated by the generator 3 can be transmitted via the pin element 40 to the conductor elements 39 leading to the anode 45. A spring element can be provided to ensure contact between the pin element and the connection element 56.

[0103] Fig. Figure 8a shows a radial section through the first sub-element 17 of the housing 12, the radial section being along the section plane designated AA in Fig. 6a is laid. The first sub-element 17 has an edge 73 which is designed to rest on a shoulder 83 of the second sub-element 18. The edge 73 extends from the first end 71 of the first sub-element 17 to the second end 72 of the first sub-element 17, see also Fig. 6a.

[0104] The edge 73 contains at least one recess between the first end 71 and the second end 72, which is located in Fig. 6a is not visible because it is located on the inside of the casing.

[0105] Fig. Figure 8b shows a radial section through the second sub-element 18 of the housing 12, which is cut along the section plane designated BB in Fig. 6c is laid down. A paragraph 83 extends from the first end 81 of the second sub-element 18 to the second end 82 of the second sub-element 18, see also Fig. 6c.

[0106] The second sub-element 18 contains at its second end 82 a ring element 84, which is designed to receive the second end 72 of the first sub-element 17. In the assembled state, the electrode 1 is housed inside the ring element 84.

[0107] According to the present embodiment, the second sub-element 18 contains a locking element 85 at its first end, which is designed to be received in a corresponding recess in the first sub-element 17. The recess is located at the first end 71 of the sub-element 17 on the inside of the end wall. It is in Fig. 6a not visible and also in Fig. 8a is not visible because it lies in front of the cutting plane, i.e., in this representation, it is part of the cut-off portion. Fig. 8b belongs to.

[0108] The cutting plane in Fig. 8b runs through the receiving opening for the charger 16, which can be detachably attached to the underside of the second sub-element. On the side of the second sub-element 18 opposite the receiving opening 86 are the electrode 1, the modulator 4, the generator 3, the processor unit containing a control, regulation and calculation module, optionally the storage unit 9, as well as the associated connections and connecting lines, which are located in Fig. 1b or Fig. 1c are shown schematically.

[0109] The first sub-element 17 and the second sub-element 18 can additionally be secured by means of a screw connection. For this purpose, the first sub-element includes a stud 77, which contains a threaded bore (not shown) that aligns with a stud 87 of the second sub-element 18 when the first sub-element 17 and the second sub-element 18 are assembled to form the housing 12.

[0110] In Fig. 8b provides an additional recess 88 immediately adjacent to paragraph 83. A hook-shaped projection 89 adjoins this recess 88. In the assembled state, this hook-shaped projection 89 engages in a corresponding recess 79 of the first sub-element 17. Thus, the hook-shaped projection 89 locks into the corresponding recess 79, causing the first sub-element 17 to cover the second sub-element 18 at the connection point, creating a double wall with a small air gap between them. This provides significantly better protection against electrical voltages at the connection point, ensuring that the person operating the device is not exposed to any danger from the electrical voltages used.

[0111] Using the therapy device according to the invention, as described in one of the embodiments, the amplitude and frequency of the voltage pulses can be adjusted by means of the control elements 5 and 15. According to one embodiment, the amplitude of the electrical voltage can be varied in the range of values ​​1 to 9. The frequency can be set between 10 and 100 pulses per second. The most powerful setting is thus achieved by selecting an amplitude of 9 and 100 pulses per second. In the following measurement examples, the most powerful setting is designated HI. The least powerful setting is thus achieved by selecting an amplitude of 1 and 10 pulses per second. In the following measurement examples, the least powerful setting is designated LO.

[0112] The pulse current was recorded using a Teledyne Le Croy Waverunner 8254M oscilloscope across a 100 Ω resistor connected between the cathode and ground, with a voltage ratio of 10:1 (Teledyne Le Croy, PP024). The optimal distance D between the plasma source and the cathode was 1 to 2 mm, with the cathode being a copper element. For this distance, the amplitude was varied between 10 and 100 pulses / s. The pulse currents were stable and corresponded to the specifications on the therapy device for all settings. Fig. 16. The electrical voltage profile was recorded for a period of approximately 200 µs.

[0113] The effect on the stability of the plasma source was investigated by adjusting the amplitude. For this purpose, the frequency of the discharge peaks in the range of 10 Hz to 100 Hz was examined using an oscilloscope. Analysis of the current pulses revealed up to 12 discharges per voltage pulse at the HI settings (amplitude 9 V, 100 pulses / s). The discharge process was most stable at the highest frequency of 100 Hz and the highest amplitude, which is why Fig. 16 is shown. Measurement example 1

[0114] The patient leakage current (I) was determined according to the measurement procedure in DIN EN 60601-1 2]. The measurement setup is shown schematically in Fig. 9 shown. The one in Fig. The circuit shown in Figure 9 depicts a low-pass filter that describes the electrical response of the human body, taking into account, in particular, that currents of higher frequency are considered less harmful. Since the therapy device 20 is designed as a wireless device, only an alternating current can be measured. Therefore, an RC element containing the circuit shown in Figure 9 was used. Fig. 9 was connected to a Fluke 116 True RMS multimeter to determine the patient leakage current. The measuring setup consists of optical holders to ensure plane parallelism between the cathode 55 and the second end 22 of the electrode 1, which forms the tip of the plasma source. The distance was precisely adjusted using a micrometer screw. The patient leakage current was thus measured as a function of the distance D between the second end 22 of the electrode 1 and the cathode 55, which is a copper plate. The patient leakage current should not exceed a maximum value of 100 µA for the therapy device to be suitable for medical use. The maximum value (▼), the minimum value (▲), and the mean value (•) of the patient leakage current were recorded over a period of 10 s. It was assumed that the maximum value was crucial for assessing the suitability for medical purposes.

[0115] According to Fig. Figure 10a shows the patient leakage current for a first therapy device (TV1) plotted on the ordinate in [µA], and the distance D in [mm] between the second end 22 of the electrode 1 and a copper plate forming the cathode 55 is plotted on the abscissa. According to Fig. At any distance, the limit of 100 µA is not reached, even with the maximum possible settings. The maximum value achieved is 12 µA at a distance of 1.5 mm. In the range of 0 to 3 mm, a filament and a stable air plasma are generated. At greater distances, no plasma was produced, although a patient leakage current was detected. For the lowest setting (LO), no patient leakage current was detected at all.

[0116] Fig. Figure 10b shows the patient leakage current for a second therapy device (TV2). For this therapy device, the maximum, minimum, and mean values ​​of the patient leakage current were recorded over a period of 10 seconds at an ambient temperature of 23 °C and 45% relative humidity. The therapy device (TV2) exhibited an audible and measurable change in the plasma as a function of the applied voltage. To achieve the highest intensity, the therapy device was wrapped with grounded aluminum foil. The maximum duration for the measurements with one charge of the energy storage unit was 25 minutes. With two charges, failures occurred after an operating time of approximately 50 minutes, during which the housing temperature of the second therapy device (TV2) reached a maximum of 43 °C.Operating times exceeding 50 minutes can lead to malfunctions in the processor unit due to increased operating temperatures, which may partially impair the operation of the control module, regulation module, or calculation module of the therapy device. Therefore, additional measurements were performed after a cooling phase of approximately 30 minutes following two charging cycles.

[0117] For the second therapy device (TV2), the patient leakage current of 100 µA was never reached. The maximum patient leakage current was 11 µA. At a distance D of 0 to and including 3 mm between the second end 22 of electrode 1 and the cathode 55, a stable secondary cold plasma was generated in the air. The frequency of discharges decreased at distances greater than 2 mm, thereby reducing the patient leakage current. For the second therapy device (TV2), no plasma could be detected visually or audibly at a distance D > 3 mm, although a small patient leakage current was measured.

[0118] Fig. Figure 10c shows the patient leakage current for a third therapy device (TV3), which contains an LSE electrode. For this therapy device, the maximum, minimum, and mean values ​​of the patient leakage current were recorded over a period of 10 seconds at an ambient temperature of 23 °C and 49% relative humidity.

[0119] For the third therapy device (TV3), the patient leakage current of 100 µA was never reached. The maximum patient leakage current was 23.5 µA when the LSE electrode touched the cathode. At a distance D of 0 to and including 3.5 mm, a stable secondary cold plasma was generated in the air between the second disc-shaped end 22 of the LSE electrode 1 and the cathode 55. The discharges became discontinuous at greater distances, although a low patient leakage current was measured.

[0120] Fig. Figure 10d shows the temperature curve in degrees Celsius as a function of the distance D between the electrode and the cathode. The distance D is plotted on the abscissa, and the temperature on the ordinate. The room temperature at the time of measurement was 23 °C with a relative humidity of 51%. For the second therapy device (TV2), the maximum measured temperature was 30 degrees Celsius. The temperature limit of 40 degrees Celsius was never reached. Measurement example 2

[0121] The spectral composition of the optical plasma radiation was determined using optical emission spectroscopy (OES). The corresponding measurement setup is shown schematically in Fig. Figure 11 shows the optical emission spectroscopy performed in the ultraviolet (UV), visible (VIS), and near-infrared (NIR) ranges using a calibrated AvaSpec 3648-USB2 fiber optic spectrometer (Avantes, Apeldoorn, NL). Plasma emission was determined using a cosine corrector (121) to increase the aperture angle. To protect the cosine corrector from direct plasma contact, a quartz window (d = 2 mm) transparent to wavelengths greater than 200 nm was attached to its electrode-facing side. The necessary mounts for the measuring instrument and the first, second, and third therapy devices (TV1, TV2, TV3) have been omitted from this illustration.

[0122] A grounded wire 123 served as the cathode 55. Due to the wire's small diameter of 0.1 mm, it barely obscured the plasma light source. The distance D between the second end 22 of electrode 1 and cathode 55 was approximately 1.5 mm, as this value corresponded to the highest patient leakage current. Five spectra were recorded and subsequently analyzed, with an integration time of 30 s for each spectrum. For medical applications, the UV irradiance is of particular interest. It was measured in two ranges, UV-A (315–380 nm) and UV-B (280–315 nm), by integrating the spectral irradiance E(λ). No emissions were detected in the UV-C range (200–280 nm).

[0123] Fig. Figure 12a shows the complete spectrum of the first therapy device (TV1), which was determined by averaging five consecutive spectra, each with a recording duration of 30 seconds. The scale on the ordinate on the left side of Fig. 12a was used for the therapy device (TV1). The spectrum of the therapy device (TV1) shows an emission of neon (Ne) and nitrogen (N2). The measurements were taken at an ambient temperature of 22.7 °C and 61% relative humidity.

[0124] Fig. Figure 12b shows a spectrum of the second therapy device (TV2). The measurements were taken at an ambient temperature of 23 °C and 50% relative humidity; otherwise, the measurement was carried out in the same manner as for the first therapy device (TV1).

[0125] Fig. Figure 12c shows a spectrum of the third therapy device (TV3). The measurements were taken at an ambient temperature of 22.5 °C and 48% relative humidity; otherwise, the measurement was performed in the same manner as for the first therapy device (TV1).

[0126] Fig. Figure 13 shows a spectrum of the third therapy device (TV3) compared to the first therapy device (TV1). Compared to (TV1), neon emissions were higher, but nitrogen emissions were lower. This could be explained by the larger area of ​​luminescent neon inside the LSE electrode. Due to its geometric design and the associated increase in the electric field at the pointed end of the electrode in the first therapy device (TV1), a focused discharge onto the cathode can be achieved. Unlike (TV1), the discharges occurred at various points along the grounded wire. Because of the wire's positioning, the plasma could not be captured in its entirety; therefore, the first therapy device (TV1) shows higher nitrogen emission values.The irradiances in the UV-A and UV-B ranges, as well as the effective irradiance of the third therapy device (TV3) at the measurement point of highest intensity, were compared with the values ​​of the first therapy device (TV1). The irradiances are relatively low, as the spectrum already indicates. The maximum daily treatment time (tmax) is very high at approximately 1 hour. However, the UV-B values ​​and the effective irradiances are higher than for the first therapy device (TV1). This may be related to the higher neon emission; however, the measurement in the weighted regions below 300 nm may also be subject to significant noise.

[0127] The International Commission on Non-Ionizing Radiation Protection has published a method for determining effective irradiance because different wavelengths cause varying degrees of damage to human skin. A spectral weighting function S(λ) must be multiplied by the spectral irradiance E(λ) and integrated over the entire UV range from 200 to 380 nm to obtain an effective irradiance E. eff to be calculated using the following formula: Eeff=λ1∫λ2E(λ)⋅S(λ)d(λ)

[0128] A maximum daily irradiation time t max can be derived from the effective irradiance E eff be calculated when the maximum daily dose of D max = 3 mJ / cm 2 is used according to the following formula: tmax=Dmax / Eeff

[0129] Table 1 below shows the irradiances for UV-A and UV-B as well as the effective irradiance E. eff The first, second, and third treatment devices (TV1, TV2, TV3) are shown. The irradiances are relatively low, as already indicated in the spectrum. No significant emissions occurred in the UV-C range. The maximum daily treatment time is very long, at 6 hours for the first treatment device and 5 hours for the second. Table 1 Vorrichtung, D E UV-A E UV-B E eff t max Dimension µW / cm 2 µW / cm 2 µW / cm 2 h (TV1) 1.5 mm 0.91 + 0.03 0.19 + 0.03 0.14 + 0.2 ~6 (TV2) 1.5 mm 1.21 + 0.05 0.22 + 0.01 0.16 + 0.2 ~5 (TV3) 1.5 mm 0.68 + 0.04 0.37 + 0.02 0.86 + 0.07 ~1 Measurement example 3

[0130] In the third measurement example, FTIR spectroscopy, or Fourier-transformed infrared absorption spectroscopy, hereinafter referred to as FTIR, was performed. FTIR was used for the qualitative and quantitative determination of the composition of the reactive species formed during the discharge. Absorption in the infrared range corresponding to the excitation of molecular vibrations and rotations is a characteristic feature of heteronuclear molecules, such as various nitrogen oxides or ozone. The determination is carried out by measuring a background radiation intensity I0 and a radiation intensity after absorption by the sample I, both of which depend on the wavenumber v. This allows the determination of an absorption coefficient A, where A = -In(I(v) / I0(v)) = Σ i (n i σ i(v)L. The absorption coefficient A is influenced by the length of the optical path as well as the density n and the wavenumber-dependent absorption cross-section σ for each species i. Plasma-chemical processes contain complex reaction networks that occur on different timescales; therefore, the species composition during discharge is variable and converges to a stationary mixture of long-lived components in the afterglow. The in Fig. The 15 measurement results shown refer to the steady state.

[0131] Fig. Figure 14 shows the measurement setup for performing FTIR spectroscopy. The gas treated by the therapy device 20, which is supplied to a container 125 through a room air inlet 126, is collected in a gas collection cell 127 and drawn into a multi-pass absorption cell (MPC) 128, which is connected to a Bruker Vertex 80v spectrometer 129. The MPC 128 has an optical path length L of 32 m and therefore also enables the measurement of low densities n of absorbing species. A vacuum pump 130 allows the room air to be introduced into the container 125 and into the MPC 128. By means of the vacuum pump 130 and an inflow throttling by a throttle valve 131, a pressure of 100 mbar was achieved in the MPC 128. The measurements were performed for the highest-performing combination (HI) and for the lowest-performing combination (LO) of the corresponding therapy device 20.The air flow rate was 30l / h for all measurements and was measured and verified by an Omega SMA66C type flow meter.

[0132] A grounded cathode 55 was placed in the container 125 at a distance D=1 mm from the second end 22 of the electrode 1 of the therapy device 20.

[0133] The measurements cover a wave number range from 700 to 4000 cm⁻¹. -1 with a resolution of 0.2 cm -1 This allows the detection of species typical of atmospheric cold plasmas, namely O3, NO, NO2, N2O, N2O5, HNO3, HNO2 and H2O2. Changes in the concentrations of CO2 and H2O in the room air were also recorded. Fig. Figure 15 shows an exemplary spectrum of the first therapy device (TV1) with inserted reference spectra for the identified species O3, N2O, and NO2. The other absorption peaks relate to CO2 and H2O or to other absorption bands of the identified species. On the abscissa of Fig. 15 is the wave number in [cm²]. -1 ] and the absorption coefficient A is plotted on the ordinate. The measurement was performed at 100 mbar, a room temperature of 24°C, and a relative humidity of 55%. The airflow rate was 30 l / h with the highest power setting (HI) on the therapy device.

[0134] In particular, the concentration of long-lived oxygen and nitrogen species (RONS) generated by the therapy device was measured using FTIR spectroscopy. These species are considered a key mechanism for achieving desired treatment effects in medical applications. Reliable identification and precise quantification of the RONS is essential for compliance with DIN SPEC 91315. O3, N2O, and NO2 were measured as the species with the highest concentrations. Since the concentrations of N2O and NO2 were already in the range of 1 ppm, thus at the lower end of the measurable range, further species with lower concentrations could not be reliably identified. The concentration of O3 was 15 ppm ± 4 ppm. The concentration of N2O was 1 ppm ± 0.05 ppm, and the concentration of NO2 was 2 ppm ± 0.5 ppm. These values ​​were determined for the highest power setting (HI) of therapy device 20.No emissions were detected for the lowest power setting (LO). 5. Measurement example

[0135] Chemical species in the liquid phase of the therapy device were identified. For this purpose, a saline solution consisting of 500 µl water and 500 µl NaCl solution was prepared in a 24-well titrant. The second end 22 of electrode 1 was positioned vertically above the liquid surface at a distance of 1 to 2 mm. Plasma treatment was applied directly to the liquid surface for 10 s, 30 s, 60 s, 180 s, and 300 s.

[0136] To determine the stability and compare the production of reactive oxygen species (ROS) from seven electrodes, the enrichment of H₂O₂ was measured immediately after contact with the plasma. Chemical parameters were also determined immediately after contact with the plasma.

[0137] pH values ​​were determined using the pH meter HANNA edge blu (Hanna instruments) based on a glass electrode in water and NaCl.

[0138] Fig. Figure 17a shows the pH value, plotted on the ordinate, as a function of the selected measurement duration, plotted on the abscissa, for the first treatment device (TV1). The measured values ​​were determined for treatment durations of 0 s (reference value), 10 s, 30 s, 60 s, 180 s, and 300 s for the LO setting of the treatment device (TV1). The left-hand bar (black) corresponds to the pH measurement for H₂O, and the corresponding right-hand bar (gray) corresponds to the measurement for NaCl. The pH measurement remains largely constant for both H₂O and NaCl at the LO setting, i.e., it does not change with increasing treatment duration.

[0139] Fig. Figure 17b shows the pH value, plotted on the ordinate, as a function of the selected measurement duration, plotted on the abscissa, for the first treatment device (TV1). The measured values ​​were determined for treatment durations of 0 s (reference value), 10 s, 30 s, 60 s, 180 s, and 300 s for the HI setting of the treatment device (TV1). The left-hand bar (black) corresponds to the pH measurement for H₂O, and the corresponding right-hand bar (gray) corresponds to the measurement for NaCl. The pH measurement decreases for both H₂O and NaCl with increasing treatment duration for the HI setting; that is, both liquids become increasingly acidic with increasing treatment time. The acidification in both liquids correlates with the treatment duration; for H2O the pH measurement decreased from 5.57 to 3.78, for NaCl the pH measurement decreased from 5.73 to 3.66.

[0140] Fig. Figure 17c shows the pH value, plotted on the ordinate, as a function of the selected measurement duration, plotted on the abscissa, for the therapy device (TV2) in water. The measured values ​​were determined for treatment durations of 0 s (reference value), 10 s, 30 s, 60 s, 180 s, and 300 s.

[0141] Fig. Figure 17d shows the pH value, plotted on the ordinate, as a function of the selected measurement duration, plotted on the abscissa, for the therapy device (TV2) in NaCl. The measured values ​​were determined here for treatment durations of 0 s (reference value), 10 s, 30 s, 60 s, 180 s, and 300 s.

[0142] The pH reading for the second therapy device (TV2) decreases for both H2O and NaCl with increasing treatment duration, meaning that both liquids become increasingly acidic as treatment time increases. The acidification in both liquids correlates with the treatment duration: for H2O, the pH reading decreased from 5.46 (+ / - 0.148) to 3.51 (+ / - 0.03), and for NaCl, the pH reading decreased from 5.87 (+ / - 0.3) to 3.44 (+ / - 0.04).

[0143] Fig. Figure 17e shows the pH value, plotted on the ordinate, as a function of the selected measurement duration, plotted on the abscissa, for the therapy device (TV3) with a first electrode in water. The measured values ​​were determined for treatment durations of 0 s (reference value), 10 s, 30 s, 60 s, 180 s, and 300 s. The pH value in the water decreased with increasing treatment duration, i.e., acidification occurred. The mean pH value fell from 6.92 to 3.98.

[0144] Fig. Figure 17f shows the pH value, plotted on the ordinate, as a function of the selected measurement duration, plotted on the abscissa, for the therapy device (TV3) with a second electrode in water. The measured values ​​were determined for treatment durations of 0 s (reference value), 10 s, 30 s, 60 s, 180 s, and 300 s. The pH value in the water decreased with increasing treatment duration, i.e., acidification occurred. The mean pH value fell from 7.15 to 4.37.

[0145] The concentration of H2O2 was determined for the first and third therapy devices (TV1, TV3) using a photometric sample with the commercially available Amplex Red reagent (10-acetyl-3,7-dihydroxyphenoaxazine, molecular formula C). 14 H 11NO4 (CAS name / number: 10H-Phenoxazine-3,7-diol, 10-acteyl -119171-73-2, molecular weight 257.25) was determined. A color reaction indicates the presence of H₂O₂. The absorbance was quantified photometrically at a wavelength of 535 nm using an Infinite® M200 PRO Tecan microplate photometer. Measurements were performed four times (n=4) for the HI and LO settings of the therapy device (TV1), except for the electrode comparison, for which only one HI setting was used for n=3.

[0146] Fig. Figure 18a shows the total concentration of H₂O₂ in [µM], plotted on the ordinate, as a function of treatment duration, plotted on the abscissa. Measurements were only documented for the HI settings of the first treatment device (TV1); for the LO settings, the H₂O₂ concentrations were below the detection threshold and outside the lowest standard point. The left-hand bar (black) corresponds to the H₂O₂ measurement for H₂O, and the corresponding right-hand bar (gray) corresponds to the corresponding H₂O₂ measurement for NaCl. The total concentration increased with increasing treatment duration for both H₂O and NaCl. The concentration of H₂O₂ in water was 3 µM after 10 s with a standard deviation of 0.1 ppm and reached 44.35 µM with a standard deviation of 1.51 ppm after 300 s. The concentration of H₂O₂ in NaCl was 2.58 µM after 10 s with a standard deviation of 0.The concentration in NaCl was 0.8 ppm and reached 42 µM with a standard deviation of 1.43 ppm after 300 s. The concentrations in NaCl appear to be lower than in water, but the deviations were within the range of the standard deviations.

[0147] Fig. Figure 18b shows the concentration of H₂O₂ in [µM], plotted on the ordinate, as a function of treatment duration, and on the abscissa in water for the second treatment device (TV2). For the second treatment device, the H₂O₂ concentrations were determined using a photometric series based on titaniumlyl(IV) oxysulfate (TiOSO₄). TiOSO₄ reacts in the presence of H₂O₂ to form a yellow-orange complex. The absorbance was quantified photometrically at a wavelength of 407 nm using an Infinite® M200 PRO Tecan microplate photometer. The measurements were performed four times (n=4). The concentrations were determined according to a standard curve for H₂O₂ at different dilutions. At very short exposure times (0 s, 10 s), the values ​​were below the detection limit and therefore not included in the calculations or in Table 2. Table 2 NaCl H2O t MW SD n MW SD n 30 s 4.86 3.28 3 19.56 8.31 2 60 s 13.56 1.19 2 20.28 13.98 4 180 s 33.89 8.61 4 55.27 14.13 4 300 s 51.17 13.47 4 81.04 19.89 4

[0148] The concentrations increased with increasing treatment duration in water, as in Fig. As shown in Figure 18e, the concentration of H₂O₂ is also high in NaCl. After short treatment times of 10 s or 30 s, the concentration of H₂O₂ is within the detection limit of the experimental setup (< 5 µM). The standard deviations are therefore higher for treatment times > 60 s. The maximum concentration was higher in water (81.04 µM) than in NaCl (51.17 µM) for a treatment time of 300 s.

[0149] Fig. Figure 18c shows the concentration of H2O2 in [µM], plotted on the ordinate, as a function of the treatment duration, plotted on the abscissa, in NaCl for the second therapy device (TV2).

[0150] Fig. Figure 18d shows the concentration of H2O2 in [µM], plotted on the ordinate, as a function of the treatment duration, plotted on the abscissa, in water for the first electrode of the third therapy device (TV3) and Fig. 18d the concentration of H2O2 for the second electrode of the third therapy device. For both electrodes, an enrichment of H2O2 occurred depending on the treatment duration, whereby a concentration of 30 µM (1.015 ppm) was reached for the first electrode and a concentration of 18.34 µM (0.624 ppm) for the second electrode after a treatment duration of 300 s.

[0151] A colorimetric reagent (Griess assay; Cayment chemicals) was used to determine nitrites and nitrates using a microtiter plate. To measure the total nitrate / nitrite concentration, nitrate was first converted to nitrite by nitrate reductase. In a second step, the nitrite was converted to a dark purple azo compound upon addition of the Griess reagent, and the nitrite was determined without nitrate reductase conversion. Standard curves for both compounds were included in the assay. Photometric measurement of the absorption coefficient at a wavelength of 540 nm using the Infinite® M200 PRO Tecan microplate photometer determined the precise concentrations of nitrite and nitrate. The measurements were repeated twice with n=3 for the first treatment device (TV1) and twice with n=5 for the second treatment device (TV2).

[0152] Fig. 19 shows the total concentration of NO2 - and / or NO3 - in [µM], plotted on the ordinate, as a function of treatment duration, plotted on the abscissa for the first therapy device (TV1). The measurements were only documented for the HI settings of therapy device 20; for the LO settings, the NO2 concentrations were - and NO3 - below the detection threshold and outside the lowest standard point. In Fig. 19a corresponds to the left-hand bar (grey) in each case to NO2 - -Measured value in H2O, the corresponding bar on the right (black) corresponds to NO3 - -Measured value in H2O. The total concentration increased with increasing treatment duration for both NO2 and NO2. - as well as for NO3 - Therefore, the concentration profiles for the HI settings show an increase in both nitrate concentration (NO3) and nitrate concentration that depends on the duration of treatment.- ) also the nitrite concentration (NO2) - ) in water. The proportion of nitrite is lower than the proportion of nitrate in water.

[0153] In Fig. 19 corresponds to the left-hand bar (black) of each month, representing NO2. - -Measured value in H2O, the corresponding bar on the right (grey) corresponds to NO2 - - Measured value in NaCl. The total concentration increased with increasing treatment duration for both NO2 and NO2. - in water as well as for NO2 - in NaCl. Thus, the concentration profiles for the HI settings show an increase in nitrite concentration (NO2) that depends on the treatment duration. - ) in both water and NaCl. The concentration of nitrite appears to be lower in water than in NaCl. 6. Measurement example

[0154] Cytotoxicity was determined using an MTT assay with the adherent skin fibroblast cell line GM00637, as described in DIN SPEC 91315. For this assay, a yellow, water-soluble 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) is converted into a blue-purple formazan, and the photometric absorbance coefficient is monitored to determine cell viability. The absorbance coefficient was recorded at 550 nm using an Infinite® M200 PRO Tecan microplate photometer.

[0155] The cells were obtained from the Coriell Institute (Camden, New Jersey, USA) and stored in a DMEM high glucose w / L glutamine (Corning®) medium to which 10% fetal bovine serum (FBS; Biochrome AG, Berlin, Germany) and 1% penicillin / strepomycin (Corning®) were added. The culture was maintained at a temperature of 37°C and 5% CO2.

[0156] On the day before the treatment, 0.5×10 5 Cells per microtiter plate were transferred to a 24-well titer plate and inoculated as described above. The number of cells and the volumes used were adjusted to the 24-well titer plate according to DIN SPEC 91315, based on the size of the plasma source of the therapy device.

[0157] Prior to plasma treatment, the cell culture medium was removed. The cells were washed twice with phosphate-buffered saline (PBS, pH 7.4) and covered with 150 µl of PBS. The cells were exposed to the plasma source for 10 s, 30 s, 60 s, 180 s, and 300 s (in triplicate). Untreated cells served as a reference. Immediately following the spot plasma treatments (i.e., within a maximum of 5 minutes after plasma treatment), 450 µl of fresh DMEM with 13% FBS was added to each well. The cell culture plates were incubated for 48 hours. Subsequently, the supernatant was replaced with fresh DMEM containing 10% FCS and 15 µl of MTT solution (5 mg / ml in PBS).

[0158] After 2 hours, the MTT medium solution was removed and the cells were washed twice with PBS. Then, 300 ml of cell lysis solution (DMSO / undiluted acetic acid / SDS) was added. Finally, the absorption coefficient was monitored and the cytotoxicity was determined relative to an untreated reference of 100%. An IC50 time was calculated, representing 50% cell viability.

[0159] In Fig. Figure 20 shows the results of the MTT test for the first treatment device (TV1), with the treatment duration plotted on the abscissa and the cytotoxicity in % on the ordinate. The plasma treatment was well tolerated by the cells. After an exposure time of 300 s, cell viability was still 65.5%, meaning the IC50 time for the treatment device was above 300 s. For all other treatment times, viability was approximately 90%, with a marginal decrease with increasing treatment duration.

[0160] In Fig. Figure 21 shows the results of the MTT test for the second treatment device (TV2). The room temperature was 22.1 degrees Celsius, and the mean relative humidity was 56.6% (range 51–60.3%). The abscissa represents the treatment duration, and the ordinate represents the cytotoxicity in %. Cell viability decreased with increasing treatment duration, corresponding to an increase in cytotoxicity with increased plasma exposure time. The calculated IC50 time for the second treatment device was 65.14 s. After the longest treatment time of 300 s, on average only 26.5% of the cells remained viable. The standard deviations for the treatment times of 60 s, 180 s, and 300 s were relatively high at >10%.

[0161] Table 3 shows the Fig. 21 underlying measurements: Table 3 Zeit Test 1 Test 2 Test 3 MW SD 10 s 71.37 84.53 84.76 80.217 7.663 30 s 64.42 66.02 70.49 66.977 3.145 60 s 40.98 58.60 66.19 55.254 12.935 180 s 22.51 39.52 46.45 36.16 12.318 300 s 19.04 46.00 23.97 29.67 14.357

[0162] In Fig. 22a and Fig. Figure 22b shows the results of the MTT test for the first and second electrodes of the third therapy device (TV3). The treatment duration is plotted on the abscissa and the cytotoxicity in % on the ordinate. After the longest treatment duration, cell viability decreased to 53.59% (±17.22%) for the first electrode and to 65.28% (±12.05%) for the second electrode. The IC-50 time was greater than 300 s for both electrodes. 7. Measurement example

[0163] An inhibition zone assay was used to determine the antimicrobial efficacy of the plasma source in the form of the LSE electrode according to DIN SPEC 91315:2014-06. The bacteria Staphylococcus aureus DSM 799 / ATCC 6538 and Staphylococcus epidermidis DSM 20044 / ATCC 14990 (DSM German Collection of Microorganisms and Cell Cultures; ATCC American Type Culture Collection) were used for the measurement. For a further measurement, the bacterium Escherichia coli K-12 DSM 11250 / NCTC 10538 (NCTC National Collection of Type Cultures) was used.

[0164] For a further measurement, the bacterium Pseudomonas aeruginosa DSM 50071 / ATCC 10145 was used. For a further measurement, the yeast Candida albicans DSM 1386 / ATCC 10321 was used.

[0165] For the tests with the LSE electrode, 100 µl of a solution of the bacterium Staphylococcus aureus (number of cells approximately 10) was used. 6A sample of colony forming units (CFU) was distributed onto a moist solid medium (soybean casein digestive agar, Carl Roth GmbH & Co. KG, Karlsruhe, Germany) and selectively treated with the plasma source, the LSE electrode. The treatment time was 1, 2, 3, 4, or 5 minutes, with the inhibition zone assay performed on the moist agar surface (N=6). The distance between the plasma source and the surface of the moist solid was approximately 1.5 mm. A cathode was positioned beneath the agar plate.

[0166] After incubating agar plates with a diameter of 84 mm at a temperature of 37°C, the dimensions of the growth inhibition zones were measured in mm. Inhibition zones are defined as areas without visible microbial growth. If the inhibition zone was not circular, the mean diameter was determined from the measurements of the largest and smallest diameters. For comparison, agar plates were inoculated but not subjected to plasma treatment. They are in Fig. 23 shown at times t=0 min to t=5 min. Table 4a 1 min DM [mm] 2 min DM [mm] 1 35,00 40,00 37,50 40,00 45,00 42,50 2 41,00 42,00 41,50 42,00 43,00 42,50 3 38,00 41,00 39,50 41,00 42,00 41,50 4 40,00 42,00 41,00 39,00 40,00 39,50 5 40,00 41,00 40,50 36,00 38,00 37,00 6 39,00 40,00 39,50 40,00 41,00 40,50 MW 39,92 40,58 SD 1,43 2,11 Table 4b 3 min DM [mm] 4 min DM [mm] 1 44,00 45,00 44,50 42,00 45,00 43,50 2 42,00 44,00 43,00 45,00 45,00 45,00 3 43,00 45,00 44,00 45,00 46,00 45,50 4 44,00 45,00 44,50 44,00 45,00 44,50 5 45,00 48,00 46,50 43,00 45,00 44,00 6 45,00 45,00 45,00 45,00 45,00 45,00 MW 44,58 44,58 SD 1,16 0,74 Table 4c 5 min DM [mm] 1 42,00 45,00 43,50 2 45,00 45,00 45,00 3 43,00 44,00 43,50 4 43,00 43,00 43,00 5 45,00 44,00 44,50 6 45,00 46,00 45,50 MW 44,17 SD 0,98

[0167] Treating the described agar plates, inoculated with bacteria as described above, with the plasma source of the LSE electrode of the therapy device resulted in zones of inhibition for Staphylococcus aureus. The size of the zones depended on the treatment duration. Six agar plates each were treated with the plasma source for 1 min, 2 min, 3 min, 4 min, and 5 min. An exemplary case is shown in Fig. 23 shown.

[0168] Fig. Figure 24 is a graphical representation of the mean values ​​(MW) according to Table 4a to Table 4c and the associated standard deviations (SD) in a bar chart, in which the treatment times are plotted on the abscissa and the mean diameters in mm are plotted on the ordinate.

[0169] The size of the zone of inhibition increased only partially with increasing treatment duration. Therefore, the influence of treatment time on the size of the zone of inhibition was less pronounced than for the formation of ROS; see in particular [reference to be added]. Fig. 22. The antimicrobial area was slightly larger than the corresponding area created by ROS formation, suggesting additional antimicrobial effects. However, the number of remaining colonies within the zone of inhibition steadily decreased with increasing treatment duration.

[0170] In comparison, measurements with EWC electrodes showed inhibition zones with diameters ranging from 14 mm for 1 min treatment duration to 16 mm for 5 min treatment duration for Staphylococcus aureus.

[0171] For the tests of the first therapy device (TV1), 100 µl of the corresponding microorganism solution (number of cells approximately 10) was used. 6A sample of colony forming units (CFU) was distributed onto a moist solid medium (soybean casein digestive agar, Carl Roth GmbH & Co. KG, Karlsruhe, Germany) and selectively treated with the plasma source, the EWC electrode. The treatment time was 1, 2, 3, 4, or 5 minutes, with the inhibition zone test performed on the moist agar surface (N=6). The distance between the plasma source and the surface of the moist solid was approximately 1.5 mm. A cathode was positioned beneath the agar plate.

[0172] After incubating agar plates with a diameter of 84 mm at a temperature of 37°C, the dimensions of the growth inhibition zones were measured in mm. Inhibition zones are defined as areas without visible microbial growth. If the inhibition zone was not circular, the mean diameter was determined from the measurements of the largest and smallest diameters. For comparison, agar plates were inoculated but not subjected to plasma treatment. For the bacterium Staphylococcus aureus, they are in Fig. 25 shown at times t=0 min to t=5 min.

[0173] They are found in the bacterium Staphylococcus epidermidis. Fig. 26 shown at times t=0 min to t=5 min.

[0174] They are found in the bacterium Escherichia coli. Fig. 27 shown at times t=0 min to t=5 min.

[0175] They are found in the bacterium Pseudomonas aeruginosa. Fig. 28 shown at times t=0 min to t=5 min.

[0176] They are found in the yeast Candida albicans Fig. 29 shown at times t=0 min to t=5 min.

[0177] The following table 5a, 5b, 5c shows the measured values ​​for the bacterium Staphylococcus aureus at times t=0 min to t=5 min at 25.4 °C and a relative humidity of 46 %. Table 5a 1 min DM [mm] 2 min DM [mm] 1 14,50 13,00 13,75 16,50 14,00 15,25 2 16,00 14,00 15,00 17,00 15,00 16,00 3 16,50 15,00 15,75 16,50 14,00 15,25 4 15,50 15,00 15,25 17,50 13,00 15,25 5 17,00 15,00 16,00 19,50 19,00 19,25 6 15,50 14,00 14,75 17,50 16,00 16,75 MW 15,08 16,29 SD 0,80 1,57 Table 5b 3 min DM [mm] 4 min DM [mm] 1 18,50 16,00 17,25 20,00 16,00 18,00 2 18,00 14,00 16,00 19,50 17,00 18,25 3 19,00 15,00 17,00 18,50 16,00 17,25 4 18,50 16,00 17,25 21,50 17,00 19,25 5 19,50 16,00 17,75 20,50 18,00 19,25 6 19,50 16,00 17,75 19,00 16,00 17,50 MW 17,17 18,25 SD 0,65 0,85 Table 5c 5 min DM [mm] 1 19,00 16,00 17,50 2 20,00 16,00 18,00 3 19,50 16,00 17,75 4 19,00 17,00 18,00 5 20,50 17,00 18,75 6 22,00 18,00 20,00 MW 18,33 SD 0,92

[0178] The following table 6a, 6b, 6c shows the measured values ​​for the bacterium Staphylococcus epidermidis at times t=0 min to t=5 min at 25.6 °C and a relative humidity of 44 %. Table 6a 1 min DM [mm] 2 min DM [mm] 1 19,00 17,00 18,00 24,00 23,00 23,50 2 17,00 15,00 16,00 20,00 16,00 18,00 3 18,00 15,00 16,50 21,50 19,00 20,25 4 17,00 12,00 14,50 22,00 19,00 20,50 5 17,00 13,00 15,00 20,00 20,00 20,00 6 18,00 13,00 15,50 21,00 17,00 19,00 MW 15,92 20,21 SD 1,24 1,86 Table 6b 3 min DM [mm] 4 min DM [mm] 1 21,00 19,00 20,00 26,00 23,00 24,50 2 28,50 23,00 25,75 29,50 30,00 29,75 3 27,50 23,00 25,25 25,00 25,00 25,00 4 20,50 17,00 18,75 29,00 29,00 29,00 5 24,00 21,00 22,50 26,00 25,00 25,50 6 22,50 20,00 21,25 23,00 20,00 21,50 MW 22,25 25,88 SD 2,82 3,06 Table 6c 5 min DM [mm] 1 23,00 23,00 23,00 2 23,00 19,00 21,00 3 25,00 25,00 25,00 4 25,00 23,00 24,00 5 27,00 25,00 26,00 6 23,50 20,00 21,75 MW 23,46 SD 1,91

[0179] The following table 7a, 7b, 7c shows the measured values ​​for the bacterium Escherichia coli at times t=0 min to t=5 min at 24.5 °C and a relative humidity of 49 %. Table 7a 1 min DM [mm] 2 min DM [mm] 1 16,50 10,00 13,25 15,50 11,00 13,25 2 14,00 11,00 12,50 16,00 12,00 14,00 3 14,50 11,00 12,75 15,00 12,00 13,50 4 15,00 11,00 13,00 16,50 13,00 14,75 5 13,50 9,00 11,25 15,00 11,00 13,00 6 15,00 10,00 12,50 16,00 13,00 14,50 MW 15,92 20,21 SD 1,24 1,86 Table 7b 3 min DM [mm] 4 min DM [mm] 1 16,50 14,00 15,25 16,50 13,00 14,75 2 17,00 15,00 16,00 17,00 13,00 15,00 3 16,00 11,00 13,50 16,50 14,00 15,25 4 16,50 13,00 14,75 18,50 16,00 17,25 5 16,50 14,00 15,25 17,00 13,00 15,00 6 17,00 14,00 15,50 17,00 14,00 15,50 MW 22,25 25,88 SD 2,82 3,06 Table 7c 5 min DM [mm] 1 15,50 11,00 13,25 2 18,50 14,00 16,25 3 16,50 12,00 14,25 4 16,50 13,00 14,75 5 16,00 12,00 14,00 6 17,00 16,00 16,50 MW 23,46 SD 1,91

[0180] The following table 8a, 8b, 8c shows the measured values ​​for the bacterium Pseudomonas aeruginosa at times t=0 min to t=5 min at 25.6 °C and a relative humidity of 44 %. Table 8a 1 min DM [mm] 2 min DM [mm] 1 10,00 9,00 9,50 10,00 9,00 9,50 2 11,50 10,00 10,75 11,50 10,00 10,75 3 11,00 10,00 10,50 11,00 10,00 10,50 4 11,00 9,00 10,00 11,00 9,00 10,00 5 10,00 9,00 9,50 10,00 9,00 9,50 6 10,00 9,00 9,50 10,00 9,00 9,50 MW 9,96 9,96 SD 0,56 0,56 Table 8b 3 min DM [mm] 4 min DM [mm] 1 15,00 11,00 13,00 14,00 11,00 12,50 2 14,50 11,00 12,75 14,50 11,00 12,75 3 14,00 11,00 12,50 14,50 12,00 13,25 4 15,00 11,00 13,00 12,00 11,00 11,50 5 14,00 11,00 12,50 12,00 10,00 11,00 6 14,00 10,00 12,00 13,00 12,00 12,50 MW 12,63 12,25 SD 0,38 0,84 Table 8c 5 min DM [mm] 1 12,00 9,00 10,50 2 13,00 10,00 11,50 3 13,00 10,00 11,50 4 14,00 11,00 12,50 5 13,00 10,00 11,50 6 14,00 11,00 12,50 MW 11,67 SD 0,75

[0181] The following table 9a, 9b, 9c shows the measured values ​​for the microorganism Candida albicans at times t=0 min to t=5 min at 25.1 °C and a relative humidity of 47 %. Table 9a 1 min DM [mm] 2 min DM [mm] 1 11,50 9,00 10,25 14,50 11,00 12,75 2 13,00 10,00 11,50 16,00 13,00 14,50 3 12,50 10,00 11,25 15,00 12,00 13,50 4 11,00 9,00 10,00 16,00 14,00 15,00 5 12,00 10,00 11,00 15,00 12,00 13,50 6 12,00 10,00 11,00 15,50 11,00 13,25 MW 10,83 13,75 SD 0,58 0,84 Table 9b 3 min DM [mm] 4 min DM [mm] 1 17,50 14,00 15,75 17,00 12,00 14,50 2 17,00 14,00 15,50 20,00 17,00 18,50 3 18,00 14,00 16,00 17,00 14,00 15,50 4 17,00 13,00 15,00 20,00 15,00 17,50 5 16,50 11,00 13,75 19,00 14,00 16,50 6 16,00 13,00 14,50 17,00 12,00 14,50 MW 15,08 16,17 SD 0,85 1,63 Table 9c 5 min DM [mm] 1 16,00 12,00 14,00 2 16,00 12,00 14,00 3 16,00 13,00 14,50 4 18,50 14,00 16,25 5 17,00 12,00 14,50 6 19,00 14,00 16,50 MW 14,96 SD 1,12

[0182] The gram-positive bacteria Staphylococcus aureus (15.08 - 18.33 mm) and Staphylococcus epidermidis (15.92-25.88 mm) exhibited the highest inhibition zone diameters, while the gram-negative strains Escherichia coli (12.54 - 15.46 mm) and Pseudomonas aeruginosa (9.96 - 12.63 mm) and the yeast Candida albicans (10.83 - 16.17 mm) were less affected by the plasma treatment with the EWC electrode.

[0183] Fig. Figure 30 shows a comparison of diameter values ​​for the bacteria Staphylococcus aureus (bar B1), Staphylococcus epidermidis (bar B2), Escherichia coli (bar B3), Pseudomonas aeruginosa (bar B4), and the yeast Candida albicans (bar B5). The treatment duration in minutes is plotted on the abscissa, and the diameter of the zone of inhibition in mm on the ordinate. For each test series, a decrease in antimicrobial efficacy was observed in the following order: Staphylococcus epidermidis>Staphylococcus aureus>Escherichia coli=Candida albicans>Pseudomonas aeruginosa.

[0184] The size of the inhibition zone increased in some cases with increasing treatment duration.

[0185] As with the first treatment device (TV1), inhibition zone tests were performed for the second treatment device (TV2) for the same microorganisms.

[0186] They are known to be effective against the bacterium Staphylococcus aureus. Fig. 31 shown at times t=0 min to t=5 min.

[0187] They are found in the bacterium Staphylococcus epidermidis. Fig. 32 shown at times t=0 min to t=5 min.

[0188] They are found in the bacterium Escherichia coli. Fig. 33 shown at times t=0 min to t=5 min.

[0189] They are found in the bacterium Pseudomonas aeruginosa. Fig. 34 shown at times t=0 min to t=5 min.

[0190] They are found in the yeast Candida albicans Fig. 35 shown at times t=0 min to t=5 min.

[0191] Fig. Figure 36 shows a comparison of the diameter values ​​for the bacteria Staphylococcus aureus (bar B1), Staphylococcus epidermidis (bar B2), Escherichia coli (bar B3), Pseudomonas aeruginosa (bar B4), and the yeast Candida albicans (bar B5). The treatment duration in minutes is plotted on the abscissa, and the diameter of the zone of inhibition in mm on the ordinate. The gram-positive bacteria Staphylococcus aureus (14.17 - 15.92 mm) and Staphylococcus epidermidis (14.25-15.67 mm) exhibited the highest inhibition zone diameters, while the gram-negative strains Escherichia coli (11.92 - 12.58 mm) and Pseudomonas aeruginosa (8.17 - 11.33 mm) and the yeast Candida albicans (10.54 - 13.17 mm) were less affected by the plasma treatment with the EWC electrode.

[0192] For each test series, a decrease in antimicrobial efficiency was observed in the following order: Staphylococcus epidermidis=Staphylococcus aureus>Escherichia coli≥Candida albicans>Pseudomonas aeruginosa.

[0193] The size of the zone of inhibition increased with increasing treatment duration. Within the period from 1 to 5 minutes, an increase of 5% for the bacterium Escherichia coli and up to 28% for the bacterium Pseudomonas aeruginosa was observed.

[0194] As with the first treatment device (TV1), inhibition zone tests were performed for the third treatment device (TV3) for the same microorganisms.

[0195] They are known to be effective against the bacterium Staphylococcus aureus. Fig. 37 at times t=0 min to t=5 min shown.

[0196] They are found in the bacterium Staphylococcus epidermidis. Fig. 38 at times t=0 min to t=5 min.

[0197] They are found in the bacterium Escherichia coli. Fig. 39 at times t=0 min to t=5 min.

[0198] They are found in the bacterium Pseudomonas aeruginosa. Fig. 40 shown at times t=0 min to t=5 min.

[0199] They are found in the yeast Candida albicans Fig. 41 shown at times t=0 min to t=5 min.

[0200] Fig. Figure 42 shows a comparison of the diameter values ​​for the bacteria Staphylococcus aureus (bar B1), Staphylococcus epidermidis (bar B2), Escherichia coli (bar B3), Pseudomonas aeruginosa (bar B4), and the yeast Candida albicans (bar B5). The treatment duration in minutes was plotted on the abscissa, and the diameter of the zone of inhibition in mm on the ordinate. The gram-positive bacterium Staphylococcus aureus (41.67–46.42 mm) exhibited the largest zone diameters. The second gram-positive bacterium, Staphylococcus epidermidis (36.42.25–41.83 mm), as well as the gram-negative strains Escherichia coli (35.50–41.00 mm), Pseudomonas aeruginosa (35.00–38.75 mm), and the yeast Candida albicans (18.42–39.00 mm), were less affected by the plasma treatment. For the yeast Candida albicans, no zone of inhibition was observed in 5 Petri dishes at longer treatment times (t = 3, 4, 5 min).

[0201] For each test series, a decrease in antimicrobial efficiency was observed in the following order: Staphylococcus aureus>Staphylococcus epidermidis=Escherichia coli(≥Candida albicans for 1 and 2 min)>Pseudomonas aeruginosa.

[0202] The size of the zone of inhibition increased in some cases with increasing treatment duration. The results for Staphylococcus aureus were comparable and therefore consistent.

[0203] Table 10 shows a comparison of the measurement results from the above measurement examples for the first, second, and third therapy devices (TV1, TV2, TV3). Any officially stipulated limit values ​​(L) are also included in the overview for guidance. The results for the patient leakage current (I), the temperature, the UV radiation, and the concentrations of the emitted gases are within the safety limits. Table 10 Bsp.Nr. Parameter Dim. L TV1 (HI) TV2 (HI) TV3 (HI) 1 I µA 100 12 11 16 2 Eeff µW / cm 2 - 0.14±0.2 0.16 0.86±0.07 2 tmax h, min - 6h 5h 1h 5 ΔpH(5 min) - - 2.43 2.43 2.86 5 H2O2 (5min) µM - 44.35 81±20 24.16+9.3 5 NO3 - (5min) µM - 49.4±10.8 27.896+4.36 24.8±11.5 5 NO2 - (5min) µM - 16.0+3.9 11.67+2.21 8.82±2.1 6 DM IC-50 s - > 300 65 7 S. AureusDM mm - 17.2 15.92 44.80 7 S. epidermidisDM mm - 22.3 15.67 36.40 7 E. Coli DM mm - 15.0 12.58 35.90 7 P. aeruginosaDM mm - 12.6 11.33 38.80 7 C. albicansDM mm - 15.0 13.17 32.90 8 IC-50 s - > 300 65 > 300

[0204] It is obvious to a person skilled in the art that many further variations are possible in addition to the described embodiments without deviating from the inventive concept. The subject matter of the invention is therefore not limited by the preceding description and is defined by the scope of protection established by the claims. For the interpretation of the claims or the description, the broadest possible reading of the claims is decisive. In particular, the terms "contain" or "include" should be interpreted as referring to elements, components, or steps in a non-exclusive sense, thereby indicating that the elements, components, or steps may be present or used, or that they may be combined with other elements, components, or steps that are not explicitly mentioned.If the claims relate to an element or component from a group which may consist of A, B, C to N elements or components, this wording shall be interpreted as requiring only a single element of this group, and not a combination of A and N, B and N or any other combination of two or more elements or components of this group.

Claims

[1] A therapeutic device for cell stimulation or cell therapy, comprising a housing (12) containing an electrode (1), a generator (3) for generating high-frequency voltage pulses, a processor unit (6) comprising a control, regulation and calculation module, a storage unit (9), at least one operating element (5, 15) and a controllable modulator (4) by means of which the generator (3) can be controlled, wherein a voltage pulse sequence comprising a plurality of voltage pulses can be generated by means of the modulator (4), wherein the frequency and duration of the voltage pulses can be adjusted arbitrarily by means of the modulator (4), wherein the electrode (1), the generator (3), the processor unit (6), the storage unit (9), the operating element (5) and the modulator (4) are arranged in the housing (12), wherein the electrode (1) contains a glass body (27) which contains a cavity in which a gas is located, wherein the electrode (1) has a first end (21),which can be coupled to the modulator (4), wherein the electrode comprises a second dome-shaped end (22), wherein the gas can be brought into the state of a non-thermal primary plasma by the voltage pulses transmitted to the electrode (1), wherein a secondary plasma can be generated by ionizing the air located in the vicinity of the second end (22) of the electrode (1). [2] Therapy device according to claim 1, wherein the frequency of the voltage pulse sequence is not constant at least in sections. [3] Therapy device according to one of claims 1 or 2, wherein the amplitude of the voltage increases during a time interval t2-t1, is constant during a time interval t3-t2 and decreases during a time interval t4-t3, wherein the duration of the voltage pulse sequence corresponds to the time interval t4-t1. [4] Therapy device according to one of claims 1 or 2, wherein the frequency increases during the time interval t2-t1, is constant during the time interval t3-t2 and decreases during the time interval t4-t3. [5] Therapy device according to one of the preceding claims, wherein the maximum frequency is in the range of 10 to 100 Hz. [6] Therapy device according to one of the preceding claims, wherein the voltage at the output of the modulator (4) is in the range of 8 V to 65 V. [7] Therapy device according to one of the preceding claims, wherein the voltage at the output of the generator (3) is in the range of 5 kV to inclusive of 25 kV. [8] Therapy device according to one of the preceding claims, wherein an energy storage unit (10) arranged in the housing (12) is provided for the energy supply for the operation of the therapy device, so that the therapy device can be operated wirelessly. [9] Therapy device according to one of the preceding claims, wherein the housing (12) contains a display element (7) by means of which, in particular, therapy and operating data can be displayed. [10] Therapy device according to one of the preceding claims, wherein the electrode (1) comprises a sensor (2) by means of which the current or voltage delivered via the electrode (1) can be detected as measured values, wherein the measured values ​​can be digitized into measurement data, wherein the measurement data can be stored in the storage unit (9), wherein the delivered energy and / or the time course of the energy delivered by the electrode (1) can be determined by means of the calculation module of the processor unit (6). [11] Therapy device according to claim 10, wherein the control module of the processor unit (6) is used to control the modulator (4) based on the measurement data, in particular to control a constant energy output and / or to control that is independent of the signal shape, so that any signal shape can be generated in the generator (3), for example a combination of amplitude and frequency modulation. [12] Therapy device according to one of claims 10 or 11, wherein the measurement data can be used to control a therapy process by means of the control module of the processor unit (6). [13] Therapy device according to claim 12, wherein the measurement data in the processor unit (6) can be linked with a timestamp, wherein the measurement data linked with the timestamp can be stored in the storage unit for storing the therapy process. [14] Therapy device according to one of the preceding claims, wherein the housing (12) is designed as one of the poles of a capacitor for capacitive coupling. [15] Therapy device according to one of the preceding claims, wherein the energy storage unit (10) is designed as a rechargeable element, typically as a lithium-ion element or as supercapacitance. [16] Therapy device according to claim 15, wherein the energy storage unit comprises a negative pole which is configured as one of the poles of a capacitor for capacitive coupling. [17] Therapy device according to one of the preceding claims, wherein the housing (12) comprises an inner surface which contains an electrically conductive or conductive surface, for example a conductive plastic or a plastic coated with an electrically conductive material.

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