WO2023052797A1 - Dispositif approprié pour traiter un organisme, y compris des traitements tels que le traitement électro-analgésique et le traitement d'œdèmes - Google Patents

Dispositif approprié pour traiter un organisme, y compris des traitements tels que le traitement électro-analgésique et le traitement d'œdèmes Download PDF

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Publication number
WO2023052797A1
WO2023052797A1 PCT/HR2022/000007 HR2022000007W WO2023052797A1 WO 2023052797 A1 WO2023052797 A1 WO 2023052797A1 HR 2022000007 W HR2022000007 W HR 2022000007W WO 2023052797 A1 WO2023052797 A1 WO 2023052797A1
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WIPO (PCT)
Prior art keywords
impulse
electrical
duration
peak value
signal
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PCT/HR2022/000007
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English (en)
Inventor
Zvonimir RUDOMINO
Original Assignee
Rt17 D.O.O.
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Application filed by Rt17 D.O.O. filed Critical Rt17 D.O.O.
Priority to EP22813334.4A priority Critical patent/EP4415806A1/fr
Publication of WO2023052797A1 publication Critical patent/WO2023052797A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0476—Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36034—Control systems specified by the stimulation parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/323—Interference currents, i.e. treatment by several currents summed in the body

Definitions

  • the invention relates to a device for treating an organism .
  • the device disclosed herein can be used for treatments such as electro-analgesia treatment and oedema treatment .
  • the application of this device is not limited to any of the treatments specified above .
  • a prevalent method of pain control i s the use of chemicals .
  • the use of chemicals can usually result in side ef fects .
  • the invention for the treatment of organism presented here includes procedures such as electro-analgesia therapy and oedema treatment , which contains : at least one electrode pair , in which each electrode has a contact surface with the organism electrical current generator set to produce an electrical signal as output to the positive pole and negative pole , where the electrode pair is connected to the poles so that when the device is in use , the electrical signal is trans ferred to the organism through the electrode contact surfaces a processor set to control the electrical signal , where the electrical signal is characterised by a ( T ) period of 1 ms to 10 s , where the electrical signal consists of at least one positive and one negative peak value which has the duration of a positive or negative peak value , where the duration of the peak value is les s than 9ps , the peak current intensity is at least 45mA, and the total power of the electrical signal is less than 75 mW
  • this invention also includes a device for electro-analgesia induction , which has visible positive effects when applied in oedema treatment and uses complex waveforms of speci fic electrical properties .
  • the output electrical signal is applied to the treated part of the body so that the contact surfaces of the electrodes are placed in electrical contact with the patient ' s body on the opposite sides of the body part being treated .
  • the electrical signals containing impulses can be used to induce increased randomness in the distribution of ions around the nerve fibre , where a certain amount of noise is introduced into the electrical impulses that are transmitted along the nerve fibre , so it can be said that the original information of the electrical nerve signal is masked with the noise .
  • the positive effect of the device presented here is caused by inducing the movement of ions in interstitial fluids and by inducing very small contractions and relaxations in the surrounding muscle tissue . It is considered that the movement of ions in interstitial fluids , together with very small muscle contractions and relaxations , are causing increased drainage of the liquid in surrounding tissue , which has a positive effect on the oedema being treated .
  • Figure 1 shows dif ferent waveforms created by the device to cause an electro-analgesic ef fect .
  • the amplitude of the waveforms shown in Figure 1 . is the output electric current of the device presented here .
  • Figure 1A shows the waveform of the electrical signal of alternating polarity, which is used in the electroanalgesic device .
  • the duration of the peak value of each electrical impulse/peak value t p is the same as the duration of the pause between two alternating impulses t pp and the duration of the pause t pau •
  • the cycle is formed between the beginning of the first peak value and ends after the negative peak value (t p + t pp + t p ) . Together with t pau , the cycle forms the T period .
  • the body part being treated is considered a completely electrically resistant load even though, in reality, it is nonlinear and has reactive components which make the rise and fall time final .
  • Figure IB shows the signal waveform, which is the result of modifying the signal waveform shown in Figure 1A. , in the way described above.
  • the electrical signal shown in Figure 1C., results in electro-analgesic effects, which are even more pronounced, while the total energy absorption level remains unchanged .
  • the described modi fication of the signal waveform is achieved by shortening the t pp pause between two alternate peak values of one t cyc cycle while maintaining the frequency .
  • the electro-analgesic effect is most pronounced when the t pp pause is shortened almost to zero as quickly as possible , as shown in Figure ID .
  • the amplitude variance of each impulse can be periodic or non-periodic , with constant or variable amplitude levels .
  • Figure 2C shows electrical impulses with a periodic oscillation of amplitude , which turned out to have a longer- lasting analgesic effect after treatment .
  • Figure 2C shows the described complex signal waveform together with the introduced periodic oscillation of amplitude .
  • the randomness added to the movement of ions can be achieved by using aperiodic amplitude variance of electrical impulses , as shown in Figure 3C .
  • Figure 3 shows the addition of aperiodic amplitude variance to electrical impulses by means of a source of the white noise signal , which is used to modulate the signal amplitude . It was determined that the introduction of aperiodic oscillations of the amplitude of electrical impulses results in a longer- lasting electro-analgesic ef fect compared to a periodic amplitude shown in Figure 2C .
  • FIG. 11 shows electrical impulses produced by the device with amplitudes varying in the time domain .
  • Figure 11 shows the signal shown in Figure ID . with an amplitude that varies in the time domain , but signal waveforms shown in Figures 2C . and 3C . may also be modif ied as described .
  • Figure 12 shows the di f ferent modified waveforms created by the device to achieve dif ferent ef fects , from the electroanalgesic treatment of oedema to the treatment of swelling around j oints affected by gout .
  • Figure 12A shows the waveform of the signal of an electrical current of alternate polarity used to achieve an electro-analgesic ef fect .
  • the duration of the peak value of each electrical impulse t pk is significantly longer than the rise time of the intensity of the electrical current of the impulse t r from 0 to t pk and longer than the tf current intensity fall time from t pk to 0 (t pk > t r > t f ) and (t pk > t r + t f ) .
  • the rise and fall time of the direct electric current impulse is modified by the construction of the device generating the electrical impulses , and they are usually in the 150 - 300ns range , which is , for example , only 5 - 10 % of the total duration of a 3ps impulse . Therefore , in this example , the total t pk duration of a 3 ps alternate impulse is within the 2 . 7 - 2 . 85 ps range .
  • the calculated absorption rate must be increased by 5 - 10% for an approximative total energy absorption rate to be calculated.
  • the peak current is measured, but it is multiplied by (tpk + t r + tf) x 2, i.e. the worst-case scenario is calculated, or the continuous measurement and addition of the multiplied products of the supply voltage and output current are performed to calculate the exact value of the energy absorption rate.
  • Figure 12B shows the waveform of the electric current signal of alternate polarity used to achieve an electroanalgesic effect and/or for oedema treatment.
  • the duration of the peak value of each electrical impulse t pk is somewhat longer than the rise time of the intensity of the electric current of the impulse t r from 0 to tp k and longer than the fall time of current intensity t f from tpk to 0 (tp k > t r + tf) .
  • the rise and fall time of the electric current of an impulse is modified by changing the device's operational parameters for generating electrical impulses.
  • t r is 35% of the total duration of the impulse
  • tf is 5% of the total duration of the impulse
  • pk is 60% of the total duration of the impulse. Therefore, in this example, the total duration of t P k of a 3 ps alternate impulse is 1.8 ps.
  • the calculated absorption rate must be increased by 40% for an approximative total energy absorption rate to be calculated, i.e. the worst-case.
  • the peak current is measured, but it is multiplied by (t pk + t r + t f ) x 2, i.e. the worst-case scenario is calculated, or the continuous measurement and addition of the multiplied products of the supply voltage and output current are performed to calculate the exact value of the energy absorption rate.
  • Figure 12C shows the waveform of the electric current signal of alternate polarity used to achieve an electroanalgesic effect and/or for treating oedema and/or for treating swellings caused by gout.
  • the duration of the peak value of each electrical impulse t pk is shorter than the rise time of the intensity of electric current of the impulse t r from 0 to t pk and longer than the fall time of current intensity tf from t pk to 0
  • the rise and fall time of the electric current of an impulse is modified by changing the operational parameters of the device for generating electrical impulses. For example, in this case, t r is 72% of the total duration of the impulse, t f is 10% of the total duration of the impulse, and t pk is 18% of the total duration of the impulse. Therefore, in this example, the total duration of t pk of a 7 ps alternate impulse is 1.26 ps . This means that the peak current can be significantly higher because its share in total energy absorption rate is significantly smaller, which enables the increase of peak value of ion movement in the interstitial fluids of the tissues being treated, i.e.
  • the calculated absorption rate must be increased by 82% to calculate the approximative total energy absorption rate, i.e. the worst-case.
  • the peak current is measured, but it is multiplied by (t pk + t r + t f ) x 2, i.e. the worst-case scenario is calculated, or the continuous measurement and addition of the multiplied products of the supply voltage and output current are performed to calculate the exact value of the energy absorption rate.
  • Figure 12D shows the waveform of the signal of the electric current of alternate polarity used to achieve an electroanalgesic effect and/or for the treatment of oedema and/or for treatment of swellings caused by gout.
  • the duration of the peak value of each electrical impulse t pk is shorter than the rise time of the intensity of electric current of the impulse t r from 0 to t pk 0 to t pk and shorter than the fall time of current intensity t f from t pk to 0 (t r > tf > t pk ) .
  • the rise and fall time of the electric current of an impulse is modified by changing the operational parameters of the device for generating electrical impulses. For example, in this case, t r is 80% of the total duration of the impulse, tf is 10% of the total duration of the impulse, and t pk is 10% of the total duration of the impulse.
  • the total duration of t pk of a 9 ps alternate impulse is 0.9 ps .
  • the peak current can be significantly higher because its share in total energy absorption rate is significantly smaller, which enables the increase of peak value of ion movement in the interstitial fluids of the tissues being treated, i.e. the improvement of oedema treatment.
  • the peak value of the output current is set to a higher value, the effect on swellings caused by gout improves because this signal shape and a high peak current are very efficient in breaking and dissolving monosodium urate crystals which are then absorbed into the bloodstream.
  • the calculated absorption rate must be increased by 90 % for an approximative total energy absorption rate to be calculated, i . e . the worst-case scenario .
  • the peak current is measured, but it is multiplied by (t pk + t r + tf ) x 2 , i . e . the worst-case scenario is calculated, or the continuous measurement and addition of the multiplied products of the supply voltage and output current are performed to calculate the exact value of the energy absorption rate .
  • Figure 12E shows the waveform of the signal of the electric current of alternate polarity used to achieve an electroanalgesic effect and/or for the treatment of oedema and/or for treatment of swellings caused by gout .
  • the duration of the peak value of each electrical impulse t pk is shorter than the rise time of the intensity of electric current of the impulse t r from 0 to t pk 0 to t pk and shorter than the fall time of current intensity t f from t pk ( t r > t pk + t f ) .
  • the linear rise and fall of output current intensity allow more accurate control over relationships of current rise time t r and current fall time tf , and the peak current duration t pk is minimised to additionally increase the peak output current so as to treat oedema more ef ficiently and without causing inj ury or discomfort .
  • FIG. 1A Illustration of output electrical signal according to the first possible embodiment of the invention
  • FIG. 2A Illustration of output electrical signal according to a further pos sible embodiment of the invention
  • Figure 3 I llustration of added aperiodic amplitude variance to electrical impulses by using a white noise signal source for modulation of the signal amplitude
  • Figure 4 Illustration of electrical signals for three channels according to one embodiment of the invention
  • Figure 5 Illustration of electrical signals for three channels according to another embodiment of the invention
  • FIG. 6 Schematic diagram of one embodiment of the device for treatment of the organism, which includes electroanalgesia treatment , treatment of oedemas and swellings caused by gout
  • FIG. 7 Schematic diagram of one embodiment of the device for treatment of the organism, which includes electroanalgesia treatment , treatment of oedemas and swellings caused by gout
  • Figure 8 Illustration of the device for treatment of the organism, including treatments such as electro-analgesia treatment and for treating oedemas and swellings caused by gout , using one electrode pair
  • Figure 9 Illustration of the device for treatment of the organism, including treatments such as electro-analgesia treatment and for treating oedemas and swellings caused by gout, using three electrode pairs
  • FIG. 10 Schematic diagram of the device for treatment of the organism, including treatments such as electro-analgesia treatment and for treating oedemas and swellings caused by gout , using three electrode pairs
  • Figure 11 Illustration of the output electrical signal according to another possible embodiment of the invention .
  • Figure 12A Illustration of the output electrical signal according to the first possible embodiment of the invention
  • Figure 12E Illustration of the output electrical signal according to another pos sible embodiment of the invention
  • FIG. 13 Schematic diagram of one embodiment of the device for treatment of the organism, including treatments such as electro-analgesia treatment and for treating oedemas and swellings caused by gout
  • FIG. 14 Schematic diagram of the second embodiment of the device for treatment of the organism, including treatments such as electro-analgesia treatment and for treating oedemas and swellings caused by gout
  • FIG. 15 Schematic diagram of the next embodiment of the device for treatment of the organism, including treatments such as electro-analgesia treatment and for treating oedemas and swellings caused by gout
  • FIG. 16 Schematic diagram of the electronic circuit for controlling the speed at which the MOSFET is switched on and of f Detailed Description of at Least One Embodiment of the Device
  • the present invention is essentially an improved device for the treatment of the organism, including procedures such as electro-analgesia treatment , oedemas treatment and the treatment of painful swellings caused by gout 100 .
  • the device contains at least one electrode pair , and each electrode has a contact surface that comes into contact with the organism .
  • the contacting surface can be mounted, placed, or held to an area of the organism to be treated . While using the device , contact surfaces are positioned on opposite sides of the area of the organism to be treated .
  • the device comprises a current generator arranged to provide an electrical signal as output to a positive and negative pole of the electrodes .
  • the current generator can be any source providing electrical energy, such as a battery or a direct current source .
  • the electrode pair is electrically wired to the poles so that , while in use , the electrical signal is transmitted to the organism through the contact surfaces .
  • this device contains a processor for the purpose of controlling the output electrical signal .
  • the processor is programmed to configure the settings of the output electrical signal .
  • the output electrical signal configured by the processor is characterised by a (T ) period of 1 ms to 10 s , where the electrical signal contains at least one positive and one negative peak value within one ( T ) period, i . e . it has the duration of a positive peak value and negative peak value , where the peak value duration is less than 9 ps .
  • the improved ef fects of the application of this device are achieved when the peak value duration is less than 9 ps because when the peak value is shorter , the electrical signals have a more pronounced and long-lasting electro-analgesic ef fect on the organism .
  • the peak intensity of the current is at least 45 mA, while the total intensity of the electrical signal is less than 75 mW . It has been determined that there are somewhat more pronounced effects on the oedemas and swellings caused by gout . The explanation of those effects can be explained by reduced oedema permeability . A shorter duration of the peak value of electrical current also improves the results related to the healing of wounds . A shorter duration of the peak value of electrical current stimulates or replaces the organism' s own bodily signals . A shorter duration of the electrical current peak value results in the breakdown and dissolution of monosodium urate crystals in the j oints .
  • the electrical signal delivered is negligible during most of the duration of a single period .
  • the duration within a period of an electrical signal close to zero will be referred to as t pau .
  • the peak value duration is shorter than 6 ps .
  • a peak value duration shorter than 6 ps yields better results than other prior art devices .
  • Electrical impulses shorter than 6 ps penetrate the organism' s skin . A possible explanation is that such impulses can penetrate already damaged cell walls .
  • the electrical current peak value of shorter than 6 ps can at least partially remove pathogens .
  • the peak intensity of the electrical current is at least 65 mA, preferably 95 mA .
  • the possible peak electrical current intensities can be up to 500 mA .
  • the peak value of electrical current in the range of 100 mA to 500 mA should preferably be combined with a peak value duration between 100 ns and 3 ps .
  • the best results were achieved with peak electrical current intensities within the 150 to 400 mA range combined with peak value durations within the 150 ns and 1 ps range .
  • a single peak has an energy of at most 1 . 5 mJ, preferabl y at most 1 mJ .
  • the power per each impulse delivered through the electrodes is 50 mW maximum and preferably 25 mW . Lower power levels correspond to an increase in comfort for the organism . It is preferable that a power domain of 1 mW to 30 mW is combined with peak durations of 100ns to 3 ps .
  • the usual period duration (which contains one positive and one negative peak value ) is between 1 ms and 10 s ( 0 . 1 - 1000 Hz ) . It is preferable for the duration of the period to be within the 10 ms to 1 s range .
  • An electrical current generator may deliver either a direct or alternate current .
  • the peak values within a single period are separated by at least the peak value separation time t pp , wherein the separation time of peak values t pp is shorter than the duration of the peak values . It has been determined that the electro-analgesic effect is strongest when the separation time of peak values is reduced . A shorter interval between peak values results in a healthier cell because it provides minimal voltage to the cell , which improves the transportation process between cells .
  • herein presented device may contain multiple electrode pairs , where each electrode has contact surfaces with the organism .
  • contact with the organism to be treated may be established at dif ferent locations .
  • the contact surfaces of the electrodes may be positioned/mounted/held around the area to be treated .
  • the generated electrical signals on each electrode pair can have a similar period, keeping in mind their phase shift .
  • the phase shift results in induced ion movement within the organism . It leads to further improvements in the results of analgesic treatment .
  • N electrode pairs may be used .
  • Using three electrode pairs has yielded good results as it enables the positioning/mounting/holding of the contact surfaces around the area to be treated, set at around 2 pi/N around that area .
  • the phase shift is such that the peak value of the electrical signal in the first electrode pair is at least 70% of its duration when the peak value of the electrical signal in the other electrode pair starts . This improves the induced movement of ions in the organism if the contact surfaces of the first electrode pair and another pair are positioned/mounted/held close to each other in the area to be treated .
  • herein presented device also contains a suitable interface connected to the processor , where the interface contains an input device for adj ustment of the energy of the electrical signal , while the processor contains a limiter which limits the increase of the energy of the electrical signal to a limit value .
  • the interface allows the operator to configure the electrical signal .
  • the user interface may contain an input device for adj ustment of the peak value duration ( or the maximum current amplitude ) of the electrical signal
  • the processor contains a converter which enables the peak value energy to remain independent of the adj ustment of the peak value duration ( or the highest current amplitude ) . It has been determined that the sensations at the established comfort level for each patient remain the same even when a signi ficantly higher current amplitude is applied if the duration of each peak value is shortened accordingly for the energy absorption rate to remain unchanged .
  • At least one peak value of the electrical signal is modulated by using a modulation signal .
  • the addition of modulation to the peak signals resulted in additional improved results .
  • the amplitude variance of each impulse may be periodic or aperiodic with a constant or variable amplitude level .
  • the modulation signal may be a periodic signal . This allows the period signal to be added to the peak signal .
  • the added periodic oscillation amplitudes result in a longer-lasting analgesic ef fect after treatment .
  • herein presented device contains circuitry for adj ustment of the rise/ fall time of the intensity of the current /voltage of the impulse of electrical signals .
  • the device By adj usting the rise/ fall time of the intensity of the current /voltage of the impulse of electrical signals , the device generates an electrical signal whose effects are optimally adj usted to di fferent types of treatment , including electro-analgesia treatments , oedema treatments ( t pk > t r + t f ) , and treatments of swellings caused by gout , i . e . breaking and dissolving uric acid accumulated in the j oints ( t r > tf > t pk ) .
  • the modulation signal is a signal with noise , preferably white noise , which , for instance , is obtained from the source of white noise .
  • white noise preferably white noise
  • This embodiment results in additional randomness of ion movement achieved by using aperiodic amplitude variance of electrical impulses .
  • Electrical impulses are modulated by using a source of white noise . It has been determined that the introduction of aperiodic amplitude oscillation of the electrical impulse will have a longer-lasting electro-analgesic effect , even when compared to a periodic amplitude oscillation .
  • the device contains at least one modulator .
  • the device contains at least one , preferably two , electronic switches controlled by a processor .
  • Each electronic switch enables the electrical signal to be turned on and off .
  • the switch may be used to conf igure the peak value duration .
  • a combination of two or more switches may be used for changing the polarity, thus allowing positive and negative peak values to be obtained .
  • the MOSFET or BJT can be used as an electronic switch .
  • the device contains at least one capacitor .
  • the capacitor can collect the charge , which will exit as a peak signal through the poles to the electrodes /contact surfaces .
  • the application of this device comprises the distribution of the electrical signal through the contact surfaces of an electrode pair , where the contact surfaces are mounted across from the area of organism to be treated; the electrical signal is characterised by a period ( T ) of 1 ms to 10 s , where the electrical signal contains at least one positive peak value and a negative peak value within one period, with the positive peak value duration and negative peak value duration , where the peak value durations are shorter than 9 ps and the total power of the electrical signal is less than 75 mW .
  • the electrical signal is delivered to the organism through the contact surfaces .
  • the two contact surfaces are placed on opposite sides of the area to be treated .
  • the device embodiment with two electrodes is shown in Figure 8 .
  • the recommended method of applying the device consists of the operator placing the contact surfaces ( 100 , 101 ) of the electrodes ( 13 , 14 ) on area 20 , which comprises the part to be treated 21.
  • the usual placement of electrodes would normally be laterally on the opposite sides of the treated nerve fibre, oedema, or joint swollen due to gout, as shown in Figures 8. and 9.
  • the placement of the electrodes on the front and back of the upper thorax, the front of the neck, and transcranial placement, should be avoided to prevent any side effects or spasms in these vital areas. People with pacemakers and similar electronic aids should not be treated to prevent the risk of dysfunction of such medical aids.
  • Figure 8. shows the application of the device, where output 10 has two poles (102,103) .
  • Suitable high- high-frequency electrical conductor 12 connects the poles (102,103) to low- resistance electrodes 13 and 14.
  • Electrodes 13 and 14 are preferably made of surgical steel to reduce an electrochemical reaction between the metal and the patient's skin and should have a diameter of 30 to 50 mm, but they are not limited to this material and diameter.
  • the contact surfaces of electrodes 13 and 14 are placed on skin 19 in opposite positions around the treated body part and laterally to nerve fibre 21. However, other positions are possible depending on the specific case to be treated by the device .
  • any electrical signals shown in Figures 1A. , IB., 1C., 1D., 20., and 30. may be used on electrodes 13 and 14, which causes movement of ions in the treated tissue, especially around nerve fibre 21.
  • the movement of ions induced by the aforementioned application of the output signal is mainly linear, with a net movement close to zero, except for a certain amount of random chaotic movement caused by the irregularity of ion concentration in tissue 20.
  • a preferable solution may include inducing the rotational movement of ions around the nerve fibre, resulting in a larger number of ions around the nerve fibre under the influence of the electrical impulses of the device, making it more efficient.
  • Figure 9 shows the device according to the invention with 3 sets of poles (102, 103, 104, 105, 106, 107) intended for three channels (CHI, CH2, CH3) .
  • the channels deliver the electrical signal, as shown in Figure 4.
  • Outputs 10 of the electrical current generator (s) are connected by high-frequency electrical conductors 12 with six low-resistance electrodes 13, 14, 15, 16, 17, and 18.
  • the contact surfaces of the electrodes are placed equally on skin 19, radially, around the body part being treated with a significant separation of 60°.
  • Each electrode pair, 13 and 14, 15 and 15, 17 and 18, is placed on the opposite sides of the treated part of the body in such a manner that the same output cables 12 from all three identical outputs 10 are placed side by side (102, 104, 106 and 103, 105, 107) .
  • Output signals from the three identical outputs 10 are synchronised in a way shown in Figure 4. to produce a rotational movement of ions in treated tissue 20 around nerve fibre 21.
  • Figure 4. shows channel CHI indicating a positive peak value. When more than 50% of t p of this peak value has passed, the next positive peak value is formed at the output of channel CH2. It is preferable that the second peak value is formed after 70% of the first peak value has passed. The third peak value on channel CH3 is formed after a similar time .
  • a negative peak value is formed as an electrical signal on channel CHI, while the positive peak value on channel CH3 is still ongoing. Any further negative peak values on CH2 and CH3 are formed after that.
  • N electrode pairs are used, it is possible to use N synchronised signals with similar settings, as shown in Figure 4.
  • the device embodiment, which uses electrical signals, as shown in Figure 4. is shown in Figure 10.
  • the three outputs (101, 102, 103) and channels CHI, CH2 , and CH3 are controlled or monitored using central processing unit 1, which is set to synchronise the three outputs, as shown in Figure 4.
  • User interface 2 is realised either in the form of an electronic indicator with a suitable input device such as a keyboard or in the form of a graphical user interface on a personal computer connected with central processing unit 1 using a digital data link 78.
  • the three synchronised output signals are then applied to the treated body part of patient 11 by placing the electrodes, as shown in Figure 9.
  • the operator initiates the treatment and adjusts the impulse duration t p , pause duration t pp , frequency, and amplitude of the output signal using user interface 2.
  • the frequency set by the operator is achieved by central processing unit 1, which adjusts t pau and automatically calculates the necessary adjustments.
  • the central processing unit 1 is set to gradually configure electrical signal output 10 to prevent the sudden accidental change of the output parameters by the operator.
  • Processor 1 contains a limiter which limits the value of changes.
  • the limiter contains a limit value, for example, "1 mJ in 10 seconds", which will effectively limit the energy surge to 1 mJ every 10 seconds, even if the operator enters a higher value rise through the user interface.
  • the operator adjusts the signal waveform to create a mild sensation on the treated part of the body, which is comfortable for the patient.
  • the timing of the duration of the treatment automatically starts.
  • central processing unit 1 turns off output 10.
  • central processing unit 1 continuously measures and calculates the percentage of the variations of the electric parameters of output 10 . I f any of the values being monitored varies by more than 5 to 10 % of the value set by the operator , central processing unit 1 immediately turns off the device to ensure the patient ' s safety and comfort .
  • Central processing unit 1 also continuously calculates the output energy of the device . I f it exceeds the preprogrammed absolute value , it immediately turns off output 10 to ensure the safety and comfort of the patient .
  • Central processing unit 1 also continuously checks its own reliability, and if a fault is found, it immediately turns off output 10 to ensure the patient ' s safety and comfort . When the operational procedure described above was followed, and the absolute limit of the absorption rate was not exceeded, there were no noted side effects or discomfort .
  • FIG. 6 An example of the embodiment of the device in compliance with this invention is shown in Figure 6 .
  • the operation of the device is monitored and controlled by the digital central processing unit 1 . Should any monitored parameters exceed their preprogrammed value , central processing unit 1 turns of f the device .
  • Central processing unit 1 used in the preferred embodiment of the device is a microcontroller or FPGA, but any appropriate programmable digital electronic device may be used instead .
  • Interaction with the operator is achieved using user interface 2 , which may be in the form of an electronic indicator with a suitable corresponding input device such as a keyboard, touchpad, rotary digital encoder , or a graphical user interface on a personal computer connected to central processing unit 1 by means of digital data link 77 , 78 .
  • the device uses a low-voltage power supply of direct current 4 , which includes a battery or appropriately isolated switching power supply with electric shock protection .
  • the output voltage (U psu ) of power supply 4 is usually between 12 and 24 V but is not limited to this value .
  • the output values of power supply 4 are constantly monitored by the central processing unit 1 through connections 71 , 72 .
  • Voltage regulator 5 is controlled by the central processing unit 1 , which also monitors the output voltage (U reg ) of voltage regulator 5 and current ( I reg ) through connections 73 and 74 .
  • Voltage regulator 5 uses the topology of a direct ( DC/DC) switching power supply due to its efficiency, compact size , and the possibility of direct digital control by means of modulating the pulse-width modulation provided by the central processing unit 1 , but any other adequate topology may be used for voltage regulation .
  • the delivered voltage is at least 50 V, preferably 100 V .
  • the central processing unit 1 is linked with a voltage regulator 5 through control lines 61 , 62 , 63 , and 64 , boost flyback or push-pull converter 22 , and electronic switches 24 and 25 .
  • Boost converter 22 is powered by voltage regulator 5 and is activated by the central processing unit 1 .
  • the output voltage of boost converter 22 is regulated by means of regulating the output voltage of voltage regulator 5 and by regulating the activation of boost converter 22 .
  • the electrical isolation between the primary and secondary winding of the transformer of the flyback converter provides additional security to the patient as it isolates it from the primary part of the electric circuit and its power supply .
  • the output capacitor 23 is charged with the output voltage of the step-up converter , and its voltage (U cap ) is constantly monitored by the central processing unit 1 using connection 75 through an electrically isolated link which is preferably optically coupled, but it is not limited to this method .
  • the amplitude of the electrical current of the output signal between output electrodes 3 is proportional to the voltage of charged output capacitor 23 .
  • the output current regulation is therefore achieved by regulating the voltage at which output capacitor 23 is charged .
  • the capacitance of output capacitor 23 must have an adequately high value to ensure that while it discharges during the desired time , such as t p , as shown in Figure 1 . , its voltage does not fall significantly so that the amplitude of the output current maintains the desired value to produce output signal waveforms such as those shown in Figure 2 .
  • the capacitance of output capacitor 23 should also have an appropriately low value to ensure appropriate regulation of the amplitude of the output signal by means of regulating the output voltage of generator 5 and regulating the activation of step-up converter 22 .
  • the discharge of output capacitor 23 and the alternation of output signal polarity are realised using two electronic switches , 24 and 25 , composed of two semiconductor switching elements such as MOSFET, but any other adequately fast switching element can be used .
  • Electronic switches 24 and 25 are controlled by central processing unit 1 through optically i solated links or by an impulse signal transformer .
  • an electrical signal can be produced, as shown in Figure 11 . by setting it as described above .
  • the electric current amplitude of electrical impulses generated by the discharge of output capacitor 23 through switches 24 and 25 is then measured in current measurement circuit 26 .
  • Current measurement circuit 26 contains a microcontroller which converts the values measured at the serial shunt resistance and sends them in digital form to central processing unit 1 through optically isolated links .
  • An alternative current measurement circuit uses a small current transformer to ensure that the device output is electrically isolated from the rest of the device .
  • FIG. 7 Another embodiment of the device for electro-analgesia and treatment of oedemas in accordance with this invention is shown in Figure 7 .
  • the functioning of the device is monitored and controlled by the central processing unit 1 . If any parameters being monitored exceed their preprogrammed value , central processing unit 1 will turn of f the entire device .
  • the operation of the device is not limited to digital control and can be achieved by other methods of electronic control .
  • the central processing unit 1 used in the preferred embodiment of the device is a microcontroller of FPGA, but any other appropriate digital processing device may be used instead . Interaction with the operator is achieved using user interface 2 .
  • the device is powered with low-voltage direct current 4 .
  • Voltage regulator 5 is controlled by the central processing unit 1 .
  • the output of electrical current generator 5 is amplitude modulated by modulator 8 (AM) , which is controlled by central processing unit 1 , capable of regulating the depth of modulation .
  • the modulating signal is a white noise signal produced by white noise source 9 .
  • White noise source 9 frequency range is 0 to 50 MHz and contains , but is not limited to , the diode , which produces white noise .
  • the output voltage of voltage regulator 5 is modulated by the white noise signal shown in Figure 3B .
  • the modulated signal is trans ferred to the primary winding of boost trans former 7 using a switch of H-bridge 6 controlled by central proces sing unit 1 .
  • the electronic switches of H-bridge 6 are comprised of four switching transistors , preferably MOSFETs , although bipolar j unction transistors may also be used .
  • the switches of H-bridge 6 and the boost transformer are arranged in the topology of the push-pull converter , but the same topology may be realised with two switching transistors and a transformer with a split primary winding .
  • the core of output transformer 7 is usually made of ferrite but is not limited to that material . Although the material of the core of output trans former 7 will suppress the white noise component of the input signal , the signal on the secondary winding of output transformer 7 still contains a certain percentage of the original white noise component, as shown in Figure 3C .
  • central processing unit 1 continuously monitors the input current Ii n and output current I ou t of the output transformer 7 and adj usts the output voltage of voltage regulator 5 to achieve the set values and maintain their stability .
  • poles 81 and 82 are the output element of the device in accordance with the invention .
  • Figure 7 also shows control lines 68 , 69 and connection 79 , which provide the value of current I in to central processing unit 1 .
  • electrical current generator 85 is marked as a combination of elements 4 , 5 , 22 -26 .
  • Another embodiment includes electrical current generator 86 , which comprises other elements , e . g . elements shown in Figure 7 .
  • FIG. 13 Another further embodiment of the device for electroanalgesia and treatment of oedemas and swellings caused by gout in accordance with this invention is shown in Figure 13 .
  • the functioning of the device is monitored and controlled by central processing unit 1 . I f any monitored parameters exceed their preprogrammed value , then central processing unit 1 will turn off the entire device .
  • Central processing unit 1 used in the preferred embodiment is a microcontroller or FPGA, but any other suitable digital processing device may be used instead .
  • Operator interaction is achieved by means of user interface 2 , which can be realised by using a screen and electromechanical components for the input of parameters such as switches , buttons , rotary encoders , etc . , but it can also be realised in other ways , for example by parameters entry and display by means of a software of a separate computer , which is digitally connected with central processing unit 1 .
  • the device is powered with direct current low-voltage source 116 in the 12 - 24 V range , but the voltage may be higher in order to decrease the primary and secondary windings ratio of step-up output transformer 127 with the goal of decreasing the parasitic capacitance of the secondary winding .
  • Direct current source 116 may be a battery or an isolated switching power supply with adequate electric shock protection .
  • the step-down voltage converter of working supply voltage 110 uses switching of linear topology and serves to regulate the amplitude of the electrical current intensity of the device ' s output electrical signal through body 128 I bo d between electrodes 113 because the amplitude I bod is proportional to the voltage on the output of the step-down voltage converter 110 , i . e . the voltage U cap to which capacitor 132 is charged .
  • step-down converter 110 The purpose of step-down converter 110 is to charge capacitor 132 to a value of U cap , which is set and/or monitored by central processing unit 120 .
  • the voltage value to which capacitor 132 is charged is in the range of 0 - 12 (24 ) V .
  • a device embodiment with two separate capacitors 132 is possible , where one lead of each capacitor is connected to one of the electronic switches 112 on the upper side of the H-bridge , and the other lead is connected to the common output of step-down converter 110 through a diode 131 for the discharge of one capacitor not to influence the voltage of the other capacitor .
  • Voltage regulator 110 is controlled by central processing unit 120 to adj ust and modulate the amplitude of the output current of the device .
  • One of the ways in which central processing unit 120 can control regulator 110 is by generating a PWM signal while constantly adj usting the length of the duty cycle of the excitation impulses based on measuring the output voltage of regulator 110 using an analogue-digital converter .
  • Another way in which central processing unit 120 can control regulator 110 is by generating a reference analogue signal using a digitalanalogue converter , which is then followed by regulator 110 on its output , so in this case , continued measuring through the analogue-digital converter is not necessary .
  • Central processing unit 120 controls step-up trans former 127 by means of switches 112 , which are connected to the H- bridge circuit .
  • Switches 112 are fast MOSFET switching transistors , and central processing unit 120 controls them through electronic circuit 111 , shown in Figure 16 . , which controls the MOSFET turn-on and turn-off speed because it has a fast output of a high output electric current intensity required for the charge and discharge of the MOSFET gate capacitance , i . e . which ensures that turning on and of f switches 112 is fast to decrease MOSFET switching losses .
  • H-bridge switches 112 , and step-up output transformer 127 are arranged according to the topology of the push-pull converter , but the same topology can be realised with two switching transistors and a transformer with a split primary winding .
  • Central processing unit 120 continuously monitors the intensity of the electric current through the primary winding of step-up output trans former 127 by measurement of the voltage drop on current shunt 118 through measurement circuit 117 , which amplifies the signal that is measured in order for central processing unit 120 to digitalise the signal using a fast external or internal analogue-digital converter to calculate and adj ust the operational parameters . Given the fact that the device produces very short electrical signal impulses , if central processing unit 120 is not fast enough to measure the signal properly and perform corrections for the duration of the electrical signal impulses , measurement circuit 117 will take the form of a signal peak detector with consequent decrease of accuracy, which is irrelevant in the practical use of the device .
  • Central processing unit 120 also continuously monitors the voltage of voltage regulator 110 in order for it to calculate and, if needed, adj ust the operational parameters . Considering that the shortest pause time between a bipolar impulse pair with a t pau duration is 1 ms as shown in Figure 1 . , central proces sing unit 120 calculates and performs the necessary adj ustments of the operational parameters during t pau - These adj ustments include adj usting the voltage of regulator 110 to set the amplitude of the electrical signal on electrodes 113 .
  • central processing unit 120 monitors the I pri current through the primary winding of step-up output trans former 127 and the U pri voltage of regulator 110 , it has data on impulse power through the primary winding of step-up output trans former
  • load resistance 121 of a known R re r value is connected in the output circuit of the device in order to enable calculation of the power and intensity of the current through the body
  • step-up output transformer 127 power P sec in the secondary winding of step-up output transformer 127 is calculated according to the formula P sec Ppri Ploss • 29
  • step-up output transformer 112277 wwiitthh a ferrite core represents a nonlinear electrical llooaadd
  • Rbod The information on Rbod is useful because the quality of the electrical connection between electrodes 113 and the body 128 can be indicated to the user, and in the case of a loss of a quality connection, central processing unit 120 can warn the user and/or stop the operation of the device to avoid discomfort which the person being treated may experience in the case of reduced contact quality.
  • step-up output transformer 127 is usually made of ferrite, while the primary and secondary winding are mutually electrically isolated.
  • the winding method of the secondary winding of step-up output transformer 127 has a significant impact on the rise time t r and fall time tf of the impulse of the generated electrical signal due to the influence of parasitic capacitance, which, together with the electrical resistance of the winding, makes an RC electric circuit, i . e . a low-pass filter . So, the electrical signals optimal for the different treatment types shown in Figures 12A . - 12 D .
  • step-up output transformer 127 can be generated by winding the secondary winding of step-up output transformer 127 in different configurations and number of layers in order to achieve the necessary parasitic capacitance with a resulting loss of the possibility of subsequent setting the rise and fall time t r and tf of the electrical signal impulse .
  • the primary to secondary windings ratio needs to be minimised as much as possible , so it is better to use a higher supply voltage of the direct current low-voltage source 116 to decrease that ratio .
  • the secondary winding is made in only one layer with a central tap and with the windings set apart so that the rise and fall time t r and t f are minimised, usually within the 150 to 350 ns range .
  • an external capacitor 122 of a known capacitance value is connected in the parallel connection with the secondary winding of step-up output transformer 127 through switch 123 to modify the time constant r of the device output .
  • Switches 123 can be small electromechanical relays controlled by central processing unit 120 in order to simplify the operation of the device for the user .
  • the polarity of the electric field i . e . the flow of electric current between the two half-periods of the electrical signal of an impulse pair
  • the tf of the first half-period of a bipolar impulse pair is further shortened by turning of f the currently active H-bridge switches 112 a bit earlier and after lapsing of time necessary for preventing a short circuit due to the slowness of MOSFET to turn off (dead-time ) by immediately turning on the remaining two switches .
  • the appearance of voltage and current of opposite polarity on the secondary winding on step-up output transformer 127 accelerates the discharge of the inherent parasitic capacitance and the capacitor 122 if it is connected to the electric circuit through switch 123 .
  • the modulation signal is a signal with noise , preferably white noise , which, for example , is obtained from the source of white noise .
  • white noise preferably white noise
  • This embodiment results in additional randomness of movement of ions by using aperiodic amplitude variance of electrical impulses .
  • Electrical impulses are modulated by using a source of white noise . It has been determined that the introduction of aperiodic amplitude oscillation of the electrical impulse will cause a longer-lasting electro-analgesic effect , even when compared to a periodic amplitude .
  • T signals do not penetrate the skin very well , in this case , electrical signal impulses capable of penetrating the subcutaneous and deeper tissues are used as a sort of carrier wave of the modulated signal because their t cyc period is significantly longer than the high-frequency signal period (T) .
  • aperiodic amplitude modulation is to be used, herein described device must contain at least one white noise source 114 , which can produce a signal in the 10 to 75 MHz range , whose output section contains a broadband amplifier which is connected to the primary winding of modulation transformer 115 .
  • White noise source 114 is controlled by central processing unit 120 by turning it on and off as required .
  • Modulation trans former 115 is realised with or without a ferrite core , and it consists of a primary winding containing 1 - 10 windings and a secondary winding containing 1 - 10 windings .
  • the primary and secondary windings ratio depends on the amplitude of the signal voltage which the white noise source 114 can produce on its output , whose value is usually 5 - 12 V pp in the conditions of relatively low impedance .
  • the amplification level of the output amplifier of white noise source 114 is fixed or can be manually altered using a potentiometer .
  • the primary to secondary windings ratio is usually 1 : 3 - 2 : 10 for a modulation signal whose amplitude is 5 - 12 V pp .
  • the windings of the primary winding may be located outside or within the secondary winding and are very tightly wound to improve their coupling .
  • a high-frequency electrical signal on the primary winding of modulation transformer 115 induces a high-frequency electrical signal in the secondary winding, whose amplitudes are added to or subtracted from the amplitude of the electrical signal impulse depending on their polarity, i . e . the amplitude of the electrical signal of the device are modulated by the high-frequency electrical signal .
  • capacitor 122 is excluded from the circuit by opening switch 123 during treatments in which aperiodic amplitude variances of electrical impulses are used . Although it is impossible to entirely preserve the monotonic aspect of the spectrum, even irregular electrical signals containing aperiodic amplitude variances have proved efficient in application compared to treatments where no aperiodic amplitude variance was used .
  • the white noise source 114 and modulation transformer 115 are in a separate closed metal box within the main metal device casing, which is connected to the central secondary winding outlet of output transformer 127 by the shortest possible electrical conductor with large surface area, and it contains its own isolated power supply for the white noise source or battery .
  • electrical conductors 129 which connect the output part of the device with electrodes 113 , are flexible high- frequency coaxial cables of identical diameters and the shortest possible length, whose outer shields are connected to the central outlet of the secondary winding of transformer 127 with the shortest possible electrical conductor of the largest possible surface area .
  • a small portion of the high-frequency signal of white noise generator 114 which is present in the secondary winding of output trans former 127 , can appear in the primary winding and influence the measurement of the intensity of electric current in the primary winding, so an RC low-pass filter can be added between the measuring point of current measurement shunt 118 and the input section of measuring circuit 117 in order to preserve the reliability of current measuring on the primary winding .
  • FIG. 14 Another embodiment of the device for electro-analgesia and treatment of oedemas and swellings caused by gout that is in accordance with this invention is shown in Figure 14 .
  • the functioning of the device is monitored and controlled by central processing unit 120 . Should any parameters being monitored exceed the pre-programmed value , central processing unit 120 will turn of f the entire device .
  • the device is not limited to digital control and can be achieved with other methods of electronic control .
  • Central processing unit 120 used in the preferred embodiment of the device is a fast microcontroller or FPGA, but any other suitable digital processing device may be used instead .
  • User interaction is achieved through user interface 119 in the form of a display screen and electromechanical components for parameter entry, such as switches , buttons , rotary encoders , etc . , but it can also be achieved by entering and displaying the parameters in the software of a separate computer linked with central processing unit 120 using a digital data link .
  • the device is powered with a direct current low-voltage source 116 with output ranging from 12 - 24 V .
  • Direct current low-voltage source 116 may be a battery or an isolated switching power supply with adequate electric shock protection .
  • Step-up converter 130 is supplied from direct current low-voltage source 116 , and its role is to regulate the amplitude of the intensity of electric current of the output electrical signal through the body 128 I bod between electrodes 113 because the amplitude I bod is proportional to the voltage at the output of step-up converter 130 , i . e . to the voltage U cap from to which capacitor 132 is charged .
  • step-up converter 130 is push-pull or flyback topology, which uses switching transistors and a ferrite trans former, and its purpose is to charge capacitor 132 with its output voltage to the voltage value U cap set by and/or monitored by central processing unit 120 .
  • the voltage value to which capacitor 132 is charged can be in the 50 - 500 V range .
  • the capacitance of capacitor 132 is selected so that the maximum amount of energy it contains while charged does not exceed the maximum allowed values necessary for safely operating the device .
  • the capacitor 132 During the discharge of the capacitor 132 , its voltage decreases , which inevitably lead to an imbalance in the amount of energy contained in the positive and negative half-period of the electrical signal through electrodes 111 , i . e . through the body of the person being treated 128 .
  • central processing unit 120 can control regulator 130 by generating a PWM signal while constantly adj usting the length of the duty cycle of excitation impulses based on measuring the output voltage of regulator 130 using an analogue-digital converter .
  • Another way for central processing unit 120 to control regulator 130 is by generating a reference analogue signal through a digital-analogue converter, which is then followed by regulator 130 on its output , although in this case , constant measurement by means of an analogue-digital converter is not necessary, it is preferable to achieve additional control by central processing unit 120 .
  • the discharge of capacitor 132 and the altering of the polarity of the output electrical signal through electrodes 111 , i . e . through the body of the person being treated 128 is controlled by central processing unit 120 by turning on and off the electronic switches 112 connected in the H-bridge circuit topology .
  • Switches 112 are fast-switching MOSFET transistors , and central processing unit 120 controls them through electronic circuit 111 , shown in Figure 16 . which controls the speed of turning the MOSFETs on and off because it provides fast output of high output electric current intensity necessary for the fast charge and discharge of MOSFET gate capacitance , i . e . they ensure that the turning on and off switches 112 is fast to minimise the circuit losses of the MOSFET .
  • Central processing unit 120 continuously monitors the intensity of the electric current flowing through the H- bridge, i . e . through electrodes 111 and the body of the person being treated 128 by measuring the voltage drop on current shunt 118 through measuring circuit 117 , which amplifies the measured signal so that it may be read and digitalised using a fast external or internal analoguedigital converter for the purposes of calculation , display, and any necessary adj ustments of the operational parameters by the central processing unit 120 .
  • measurement circuit 117 will take the form of a signal peak detector .
  • Central processing unit 120 also continuously monitors the voltage of the voltage regulator 130 to calculate , display, and adj ust the operational parameters if required . Because the shortest pause time between a bipolar impulse pair with a duration tp au as shown in Figure 1 . is 1 ms , central processing unit 120 calculates and performs necessary adj ustments of the operational parameters of the device during t pau , such as adj usting the voltage of regulator 130 to set the amplitude of the electrical signal on electrodes 113 , i . e . the electrical current through the body of the person being treated 128 .
  • central processing unit 120 which continuously monitors a set of electrical parameters of the device . Should any of the values significantly exceed the default values , central processing unit 120 immediately turns off step-up converter 130 and electronic switches 112 .
  • the electrical signals optimal for the di fferent types of treatment shown in Figures 12A . - 12 D . can be generated by changing the rise time t r and fall time t f of the impulse amplitude of the electrical signal .
  • external capacitor 122 of known capacitance is connected in parallel with the output electrodes 111 using switch 123 , in order to modify, i . e . to lengthen the time constant t of the output section of the device .
  • switch 123 By closing switch 123 , the rise time t r and fall time tf of the impulse of the electrical signal are increased, i . e .
  • Switches 123 may be small electromechanical relays controlled by central processing unit 120 to simplify the adj ustment process for the user of the device .
  • capacitor 122 When capacitor 122 is connected in parallel to the output circuit of the device in order to increase t r , and it is necessary to additionally decrease t f , immediately after the first half-period of bipolar impulse ends , only the electronic switch 112 located on the lower side of the H- bridge , which was turned on during the first half-period, is turned off . After the time necessary for the MOSFET to completely close runs out (usually 30 - 60 ns ) , a second switch 112 , which was turned off for the duration of the first half-period, is briefly turned on . By briefly turning on both electronic switches 112 on the upper side of the flbridge , capacitor 122 is short-circuited, and its discharge time is significantly shortened .
  • both electronic switches 112 on the upper side of the flbridge are turned off , and the regular work cycles of electronic switches 122 may continue after the time necessary for the complete shut-down of the MOSFET ( 30 - 60 ns ) has lapsed .
  • the modulation signal is a signal with noise , preferably white noise , which, for example , is obtained from the source of white noise .
  • white noise preferably white noise
  • This embodiment results in additional randomness of movement of ions by using aperiodic amplitude variance of electrical impulses .
  • Electrical impulses are modulated by using a source of white noise . It has been determined that the introduction of aperiodic amplitude oscillation of the electrical impulse will cause a longer-lasting electro-analgesic effect , even when compared to a periodic amplitude .
  • T s ignals do not penetrate the skin very well , in this case , electrical signal impulses capable of penetrating the subcutaneous and deeper tissues are used as a sort of carrier wave of the modulated signal because their t cyc period is significantly longer than the high-frequency signal period (T ) .
  • I f aperiodic amplitude modulation is to be used, herein described device must contain at least one white noise source 114 , which can produce a signal in the 10 to 75 MHz range , whose output section includes a broadband amplifier which is connected to the primary winding of modulation transformer 115 .
  • White noise source 114 is controlled by central processing unit 120 by turning it on and of f as required .
  • Modulation trans former 115 is realised with or without a ferrite core , and it consists of a primary winding containing 1 - 10 windings and a secondary winding containing 1 - 10 windings .
  • the primary and secondary windings ratio depends on the amplitude of the signal voltage which the white noise source 114 can produce on its output, whose value is usually 5 - 12 V pp in the conditions of relatively low impedance .
  • the amplification level of the output amplifier of white noise source 114 is fixed or can be manually altered using a potentiometer .
  • the primary to secondary windings ratio is usually 1 : 3 - 2 : 10 for a modulation signal whose amplitude is 5 - 12 V pp .
  • the windings of the primary winding may be located outside or within the secondary winding and are very tightly wound to improve their coupling .
  • the appearance of a high-frequency electrical signal on the primary winding of modulation transformer 115 induces a high-frequency electrical signal in the secondary winding, whose amplitudes are added to or subtracted from the amplitude of the electrical signal impulse depending on their polarity, i . e . the amplitude of the electrical signal of the device are modulated by the high-frequency electrical signal .
  • capacitor 122 is excluded from the circuit by opening switch 123 during treatments in which aperiodic amplitude variances of electrical impulses are used .
  • the white noise source 114 and modulation transformer 115 are located in a separate closed metal box within the main metal device casing, which is connected to the central electrical common point ("ground” ) of the device by the shortest possible electrical conductor with large surface area , and it contains its own isolated power supply for the white noise source or battery .
  • electrical conductors 129 which connect the output part of the device with electrodes 113 , are flexible high-frequency coaxial cables of identical diameters and the shortest possible length, whose outer shields are connected to the central electrical common point ("ground" ) of the device with the shortest possible electrical conductor with the largest possible surface area .
  • ground central electrical common point
  • the capacitance between the central conductor and the outer shield of a high-frequency coaxial cable can cause the increase of t r and t f
  • flexible single-core cables with the biggest possible diameter i . e . electrical conductor surface
  • a small portion of the high-frequency signal of white noise generator 114 which is present in the output section of the device , may appear on the current measurement shunt 118 and influence the measurement of the intensity of the electric current , so an RC low-pas s filter can be added between the measuring point of current measurement shunt 118 and the input section of measuring circuit 117 to preserve the reliability of current measurement .
  • FIG. 15 Another embodiment of the device for electroanalgesia and treatment of oedemas and swellings caused by gout that is in accordance with this invention is shown in Figure 15 .
  • the functioning of the device is monitored and controlled by central processing unit 120 . Should any parameters being monitored exceed the pre-programmed value , central processing unit 120 will turn off the entire device .
  • Central processing unit 120 used in the preferred embodiment of the device is a fast microcontroller or FPGA, but any other suitable digital processing device may be used instead .
  • User interaction is achieved through user interface 119 in the form of a display screen and electromechanical components for parameter entry, such as switches , buttons , rotary encoders , etc . , but it can also be achieved by entering and displaying the parameters in the software of a separate computer linked with central processing unit 120 using a digital data link .
  • the device is powered with a direct current low-voltage source 116 with output ranging from 12 - 24 V .
  • Direct current low-voltage source 116 may be a battery or an isolated switching power supply with adequate electric shock protection .
  • Step-up converter 130 is supplied from direct current low-voltage source 116 , and its role is to regulate the amplitude of the intensity of electric current of the output electrical signal through the body 128 I bod between electrodes 113 because the amplitude Ibod is proportional to the voltage at the output of step-up converter 130 , i . e . to the voltage U cap from to which capacitor 132 is charged .
  • step-up converter 130 is push-pull , or flyback topology, which uses switching transistors and a ferrite transformer, and its purpose is to charge capacitor 132 with its output voltage to the voltage value U cap set by and/or monitored by central processing unit 120 .
  • the voltage value to which capacitor 132 is charged can be in the 50 - 500 V range .
  • the capacitance of capacitor 132 is selected so that the maximum amount of energy it contains while charged does not exceed the maximum allowed values necessary for safely operating the device .
  • the capacitor 132 During the discharge of the capacitor 132 , its voltage decreases , which inevitably lead to an imbalance in the amount of energy contained in the positive and negative half-period of the electrical signal through electrodes 111 , i . e . through the body of the person being treated 128 .
  • central processing unit 120 can control regulator 130 by generating a PWM signal while constantly adj usting the length of the duty cycle of excitation impulses based on measuring the output voltage of regulator 130 using an analogue-digital converter .
  • Another way for central processing unit 120 to control regulator 130 is by generating a re ference analogue signal through a digital-analogue converter, which is then followed by regulator 130 on its output , although in this case , constant measurement using an analogue-digital converter is not necessary, it is preferable to achieve additional control by central processing unit 120 .
  • the discharge of capacitor 132 and the altering of the polarity of the output electrical signal through electrodes 111 , i . e . through the body of the person being treated 128 is controlled by central processing unit 120 by turning on and off the electronic switches 112 connected in the H-bridge circuit topology .
  • Switches 112 are fast-switching MOSFET transistors , and central processing unit 120 controls them through electronic circuit 111 , shown in Figure 16 . which controls the speed of turning the MOSFETs on and off because it provides a fast output of high output electric current intensity necessary for the quick charge and discharge of MOSFET gate capacitance , i . e . they ensure that the turning on and off switches 112 is fast to minimise the circuit losses of the MOSFET .
  • Central processing unit 120 continuously monitors the intensity of the electric current flowing through the H- bridge , i . e . through electrodes 111 and the body of the person being treated 128 by measuring the voltage drop on current shunt 118 through measuring circuit 117 , which amplifies the measured signal so that it may be read and digitalised using a fast external or internal analoguedigital converter for the purposes of calculation , display, and any necessary adj ustments of the operational parameters by the central processing unit 120 .
  • measurement circuit 117 will take the form of a signal peak detector .
  • Central processing unit 120 also continuously monitors the voltage of the voltage regulator 130 in order to calculate , display, and adj ust the operational parameters if required . Because the shortest pause time between bipolar impulse pairs with a duration t pau as shown in Figure 1 . is 1 ms , central processing unit 120 calculates and performs necessary adj ustments of the operational parameters of the device during t pau , such as adj usting the voltage of regulator 130 to set the amplitude of the electrical signal on electrodes 113 , i . e . the electrical current through the body of the person being treated 128 .
  • central processing unit 120 which continuously monitors a set of electrical parameters of the device . Should any of the values significantly exceed the default values , central processing unit 120 immediately turns of f step-up converter 130 and electronic switches 112 .
  • the electrical signals optimal for the different types of treatment are shown in Figures 12A . - 12E . can be generated by altering the rise time t r and fall time t f of the amplitude of the impulse of the electrical signal .
  • Fast transistor 124 is used to adj ust t r and t f . It is placed in the series connection with the negative pole of the H-bridge power supply, thus controlling the intensity of the electric current flow I bod through the H-bridge , i . e .
  • Transistor 124 is controlled by fast operational amplifier 126 in a noninverting amplifier configuration .
  • the inverting input of fast operational amplifier 126 is directly connected to the measurement current shunt 118 because its voltage drop U sh is proportional to the intensity of the electric current I bod , so it is suitable for use in a negative feedback connection of operational amplifier 126 .
  • the set modulation signal of amplitude I bod is brought to a non-inverting input of operational amplifier 126 from modulation signal generator 125 .
  • Modulation signal generator 125 generates signal waveforms for modulation of I bod by using direct digital synthesis ( DDS ) in accordance with the parameters set by the device user , and it consists of a very fast digital-analogue converter and an FPGA processor which controls it based on the set parameters and timing synchronization signal received from central processing unit 120 using a digital data link .
  • the modulation signal generator may alternatively be realised with an analogue waveform generator which is controlled by central processing unit 120 or directly by manual regulation .
  • central processing unit 120 can perform the signal generator function for modulation of I bod -
  • the signals for turning switches 112 on and of f should have s brief time delay ("time of f set" ) in relation to signals on the non-inverting input of operational amplifier 126 for the timings of output signal amplitude to rise, polarity reversal and fall may coincide .
  • the modulation signal is a signal with noise , preferably white noise , which, for example , is obtained from the source of white noise .
  • white noise preferably white noise
  • This embodiment results in additional randomness of movement of ions by using aperiodic amplitude variance of electrical impulses .
  • Electrical impulses are modulated by using a source of white noise . It has been determined that the introduction of aperiodic amplitude oscillation of the electrical impulse will cause a longer-lasting electro-analgesic effect , even when compared to a periodic amplitude .
  • T signals do not penetrate the skin very well , in this case , electrical signal impulses capable of penetrating the subcutaneous and deeper tissues are used as a sort of carrier wave of the modulated signal because their t cyc period is signi ficantly longer than the high-frequency signal period ( T ) .
  • the processor of modulation signal generator 125 must synthesise the carrier and modulation waves mathematically (pseudorandom noise in the 10 - 75 MHz range ) in accordance with the parameters set by the user and then convert them into numerical values suitable for digital-analogue conversion for each signal sample .
  • Digital-analogue conversion results in an analogue signal which is brought to the input of the current regulation circuit , which consists of operational amplifier 126 and transistor 124 , thus modulating the intensity of the electric current I bO d with the signal shown in Figure 3 .
  • electrical conductors 129 which connect the output part of the device with electrodes 113 , are f lexible high-frequency coaxial cables of identical diameters and the shortest possible length, whose outer shields are connected to the central electrical common point ("ground" ) of the device with the shortest possible electrical conductor with the largest possible surface area .
  • the embodiment of the electronic circuit for controlling the MOSFET turn-on and turn-of f speed is shown in Figure 16 .
  • the control signal for turning the MOSFET on and off transmitted by central processing unit 120 is brought to the input part of MOSFET gate driver 133 , which can produce a fast signal of high current intensity on its output in order to shorten the MOSFET 112 turn-on and turn-off times .
  • MOSFET gate driver 133 can be realised by using discrete transistors topologies , but specialised integrated circuits are more practical because they allow for the reduction of the number of electronic components in the device , i . e . simplify the electrical diagram of the device .
  • the control of the MOSFET turn-on and turn-off time is realised by changing the value of resistors 135 in the series connection between the output part of MOSFET driver 133 and MOSFET gate 112 in order to alter the intensity of the electric current of the MOSFET gate capacitance during charge and discharge .
  • Rectifying diodes 139 are used to separate the group of series resistors 135 and switches 134 , which control the MOSFET turn-on speed, from the group which controls the MOSFET turn-off speed .
  • the user can set the MOSFET turn-on and turn-off speed with more precision by turning dif ferent switches 134 on and of f as required .
  • Switches 134 can be small electromechanical relays controlled by central processing unit 120 to simplify the operation of the device for the user .

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

Abstract

L'invention concerne un dispositif pour traiter des organismes, y compris des procédures telles que la thérapie d'électro-analgésie et le traitement d'œdème (100). Le dispositif (100) consiste en au moins une paire d'électrodes, dont chaque électrode présente une surface de contact destinée à être en contact avec l'organisme, un générateur de courant électrique qui délivre le signal électrique en sortie au pôle positif et négatif, et un processeur (1) qui commande le signal. Pendant l'utilisation du dispositif, le signal électrique est délivré à l'organisme. Le signal électrique a une période de 1 ms à 10s. Dans une période, il contient au moins une valeur de pic positive et une valeur de pic négative, qui a la durée d'une valeur de pic positive ou négative, les durées de valeur de pic étant inférieures à 9 microsecondes, l'intensité de courant de crête étant d'au moins 45 mA, et l'intensité totale du signal électrique étant inférieure à 75 mW.
PCT/HR2022/000007 2021-10-01 2022-09-30 Dispositif approprié pour traiter un organisme, y compris des traitements tels que le traitement électro-analgésique et le traitement d'œdèmes WO2023052797A1 (fr)

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EP22813334.4A EP4415806A1 (fr) 2021-10-01 2022-09-30 Dispositif approprié pour traiter un organisme, y compris des traitements tels que le traitement électro-analgésique et le traitement d'¿dèmes

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HRP20211548AA HRP20211548A1 (hr) 2021-10-01 2021-10-01 Uređaj za liječenje organizma koji uključuje postupke kao što je liječenje elektro-analgezijom i/ili liječenje edema
HRP20211548A 2021-10-01

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120022612A1 (en) * 2004-05-24 2012-01-26 Bioinduction Ltd. Electrotherapy apparatus
US20170354820A1 (en) * 2011-11-15 2017-12-14 Neurometrix, Inc. Apparatus and method for relieving pain using transcutaneous electrical nerve stimulation
EP3639883A1 (fr) * 2018-10-18 2020-04-22 CEFALY Technology Sprl Stimulation e-tns kilohertz
US20200188663A1 (en) * 2016-08-15 2020-06-18 Ipulse Medical Ltd. Electrical device for providing pain relief

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120022612A1 (en) * 2004-05-24 2012-01-26 Bioinduction Ltd. Electrotherapy apparatus
US20170354820A1 (en) * 2011-11-15 2017-12-14 Neurometrix, Inc. Apparatus and method for relieving pain using transcutaneous electrical nerve stimulation
US20200188663A1 (en) * 2016-08-15 2020-06-18 Ipulse Medical Ltd. Electrical device for providing pain relief
EP3639883A1 (fr) * 2018-10-18 2020-04-22 CEFALY Technology Sprl Stimulation e-tns kilohertz

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EP4415806A1 (fr) 2024-08-21

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