METHOD FOR IDENTIFYING OPTIMAL REGIONS FOR CARDIOVERSION THERAPY (VARIANTS)
The group of inventions relates to medicine (physiotherapy). Electric stimuli which are generated by the following ringing circuit: active electrode-inductive storage unit-passive electrode-interelectrode tissues-active electrode, contain oscillations which are used as a test signal. In one variant of the method the electrodes are successively applied (in another variant—moved uniformly) across the skin area. Every time the electrodes-to-skin contact is detected, the oscillation parameters are recorded after a delay. Moreover, the values of parameters can be averaged. The group of invention provides the use of both combined and disjointed (separated) electrodes. An optimal zone for electropulse therapy is identified by minimal or maximal value of one or more parameters of the aforementioned oscillations and the use of the principle of “small asymmetry”. The group of inventions provides an increase in the accuracy with which zones optimal for electropulse therapy are identified and localized.
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The present patent application is a National stage patent application from PCT application PCT/RU2017/000080 filed Feb. 17, 2018 which claims priority to Russian patent application RU2016107880 filed Mar. 3, 2016.
TECHNICAL FIELDThe group of inventions refers to physiotherapy, in particular, the means of electropulse stimulation of the human skin by SCENAR devices and similar to those, in which the inductive energy storage unit is used for generating stimuli, and can be used in diagnostic, therapeutic, rehabilitation and preventive purposes.
BACKGROUND OF THE INVENTIONCurrently, the stimulators using this principle are manufactured in Russia (SCENAR, DENAS, TINER, etc.) as well as in other countries (Interx, Avazzia, Physiokey, etc.).
An important aspect of the use of such stimulators is the search for the zones optimal for electric stimulation.
The use of inductive energy storage unit for stimuli generation allows to assess the reaction of the inter-electrode tissues (primarily skin) along with the stimulation, to evaluate the body's reaction to the stimulation in general, and thus, to evaluate the electrophysiological condition of a body.
From the summary and the description of the device in RU Patent No. 2068277, IPC 6 A61N1/36, published on 27 Oct. 1996, results a method, according to which the active and passive electrodes, connected to a switch amplifier with an output transformer, are placed on the patient's skin, the parameters of free oscillations that arise during that are measured, and body reaction to the stimulation is identified by the speed of changing of duration of the first half wave of the aforementioned oscillations, whereas the nature of pathology is identified by duration of the first half wave of these oscillations. (Free oscillations are mistakenly called forced oscillations in the description).
This method allows the evaluation of the body's reaction to the stimulation with the selected criteria, but does not provide for the search of zones optimal for electropulse therapy, which can be carried out using the same criteria by identifying the skin areas that are most different from those of the surrounding skin.
The drawback of this method is the considerable dependence of the parameters of free oscillations on the speed and force of the electrode pressing to the patient's skin, especially when the electrodes are being applied to the skin.
Their minor deviations may result in significant differences in the measured values of free oscillations parameters and, therefore, an incorrect identification of the body's reaction to the stimulation or the nature of pathology.
Another drawback of this method is the lack of averaging of measured values, which can also lead to a significant error in the evaluation of the body's reaction to the stimulation or the nature of pathology due to the high variability (dynamic properties) of the signal.
In addition, this method does not provide an evaluation of the body's reactions to the stimulation when the electrodes are moved along the skin.
The closest to the proposed one method of evaluating the electrophysiological condition of the human body is to apply electrodes to the skin, transmit an electric signal from high-quality inductor coil saturated with electromagnetic power through the interelectrode tissue, and use as a test signal the electric oscillations arising in the ringing circuit, formed by the following parts: active electrode-a high-quality inductor coil-passive electrode-interelectrode tissue-active electrode, an evaluation of the electrophysiological condition of the body by measuring the frequency, or amplitude, or damping of these oscillations (RU Patent No. 2161904 C2, A61V5/05, A61N 39/00, published on 20 Jan. 2001).
This method allows to perform the evaluation of the electrophysiological condition of the human body or, according to the description of the invention, of its particular organs and systems, using the results of measuring the parameters of free oscillations arising during the said stimulation.
Although this method does not support the searching of the optimal zones for electropulse therapy, it can also be used for these purposes by identifying the skin areas that are most different from the surrounding ones by the measurements of frequency, or amplitude, or damping of oscillations occurring in the aforementioned ringing circuit.
However, due to the lack of delay between the application of electrodes to the skin and the measurement of oscillations parameters, and also because there is no averaging of oscillation parameter values, this method cannot ensure the gage reproducibility in case of deviations in the speed of electrode application or the force of electrode pressing to the patient's skin.
Another drawback of this method is that it allows an evaluation of the electrophysiological state only in static condition, and does not allow it to be carried out when the electrodes are moved along the skin.
SUMMARYThe aim to which the proposed invention is directed is to minimize the influence of such unavoidable subjective factors as non-uniformity of the speed of application and force of pressing of the electrodes on the skin on the results of measurement of parameters of free oscillations, which appear during the electropulse stimulation with stimuli generated by the inductive energy storage unit when searching for optimal zones for electropulse therapy by successive electrode applications.
As a result, the reliability of identification and accuracy of localization of optimal zones for electropulse therapy are increased when parameters of free oscillations are used for their searching.
The second aim to which the proposed invention is directed is to provide the possibility of searching optimal zones for the electropulse therapy during the labile method of stimulation, when the electrodes are moved uniformly across the entire surface of the chosen skin area.
The technical result of using the proposed method is the increasing of objectivity and accuracy in identifying the optimal zones for electropulse therapy by reducing the influence of subjective factors, and, also, providing the possibility of such search during labile stimulation.
By the optimal zone for electropulse therapy is understood the zone on the surface of chosen skin area, which is most different from other parts of the same surface.
Several contiguous zones are considered one zone.
If several non-contiguous zones with equal parameters are found, the zone with the smallest of them is considered as the optimal zone for stimulation.
The technical result of the invention is:
during the electrostimulation, which includes applying electrodes on the skin and transmitting electric pulses through the electrodes from inductive energy storage unit, the device's electrodes are successively placed across the entire surface of the chosen skin area and, after a set period between 0.1-0.5 sec following each detection of contact between the electrodes and the skin, the oscillation parameters are averaged and recorded, whereas the optimal zone for electropulse therapy is identified by minimum or maximum averaged value of one of the oscillation parameters or by the averaged oscillation parameters achieving the predefined criterion.
If several non-contiguous zones with equal averaged extreme parameter values or equal criterion values are found, the smallest of them is considered as the optimal zone for stimulation.
The second variant, instead of successive placing, is the labile (movable) stimulation by electrodes of the chosen skin area. In this case, the electrodes are moved uniformly across the entire surface of the area in one or more repetitions, and, after a set period of between 0.1-0.5 seconds following each detection of contact between the electrodes and the skin, the minimums and maximums of one of the free oscillation parameters, or the consistency of the values of the oscillation parameters with the predefined criterion are found and recorded, and the optimal zone for the electropulse therapy is determined by the minimum or maximum value of one of the oscillation parameters, or by achievement of the predefined criterion by the parameter values.
In this method, extremes or criteria can also be found for averaged parameter values.
If in any of these subvariants several non-contiguous zones with equal averaged extreme parameter values (instantaneous or averaged, respectively) or equal criterion values are found, the smallest of them is considered as the optimal zone for stimulation.
Both variants provide for the use of the combined electrode, containing both active and passive electrodes, and disjointed (separated, splitted) ones, where the active and passive electrodes are constructively separated, with one of them placed outside the chosen skin area and the second one applied or moved within it.
The invention is explained by the following drawings:
The first variant is to search the optimal zones for electropulse therapy by the successive placement of the electrodes.
It is known that when the electrodes contact the skin surface, which is generally a complex mixture of aqueous solutions, a number of processes occur at the “metal-solution” boundary.
This is, above all, the formation of the difference of potentials (double electric layer) called electrode potential (Grechin, V. (1997), “Neurophysiology techniques,” Nauka, p. 7-9).
The functional diagram of the output stage of the device, that influences by the stimuli generated with the inductive storage unit, is shown in the
The output stage includes inductive energy storage unit 1 with internal active resistance 2, connected to the power source 3 through switch 4 and to electrodes 5 and 6, which are placed on the tissue of the biological object, the electric equivalent of which is presented by the RC circuit 7 (see Popechitelev, E. P. and M. Kornevski, (2002), “Electricophysiological and photometric medical equipment. Theory and Design,” Vysshaya Shkola, p. 64-65). This circuit includes the Rp resistance, the double-layer capacity C and the interelectrode tissues' resistance rs.
The interelectrode impedance for impulse current is almost entirely determined by the impedance of the double electric layer Rp and C, which changes over time during the formation of the aforementioned layer, both components are changed significantly and also quite quickly immediately after the electrodes are placed on the skin.
General change of Rp and C over time is shown on
On
After that, the changes of the double electric layer's impedance (Rp and C) are negligible and determined primarily by the electro-chemical reactions associated with the local metabolism under the electrodes.
The influencing stimuli are generated in the following way.
In the initial position, switch 4 is open.
When switch 4 is closed, the first stage of the stimulus generation begins, in which the voltage from power supply 3 is applied to the inductive storage 1, which causes a flow of a linearly increasing current through it, and, thus, the accumulation of electromagnetic energy by inductive storage 1.
That is, the energy is “pumping” into inductive storage 1, and, hence, the other name of the first stage of the stimulus is “pumping”.
At this stage, the inductive storage 1 with active resistance 2, as well as the power source 3 with the switch 4 are connected parallel to interelectrode tissues 7.
As the internal resistance of the power supply 3 and switch 4 (around several Ohm, these resistances are not shown on the diagram due to the small values) are significantly less than impedance of interelectrode tissues 7, the stimulus shape during the first stage is almost independent from the impedance of interelectrode tissues 7.
After the specified amount of power is reached, inductive storage 1 is disconnected from power source 3, breaking switch 4.
The second stage of the stimulus generation begins, in the process of which the energy accumulated during the previous stage by inductive storage 1, is transferred through electrodes 5 and 6 to the tissues of biological object 7 and generates free electric oscillations in the ringing circuit, formed by the inductivity of the storage 1 and the impedance of interelectrode tissues 7.
Now the small inner resistance 2 of the inductive storage 1 is connected sequentially with impedance of interelectrode tissues 7, so the shape of the oscillations is completely determined by the impedance of interelectrode tissues 7 and the induction of the storage 1.
The other name of the second stage is “free oscillations”.
This method of creating of oscillations is known as “shock excitation”, and the mentioned circuit is known as the shock-excited oscillatory circuit or the ringing circuit.
An example of the shape of a two-stage stimulus generated with inductive storage unit is presented in
To illustrate how changes of Rp and C affect the type of free oscillations,
From the presented oscillograms and graphs of changes of Rp and C over time it is clear that the parameters of free oscillations immediately after the electrodes are placed on the skin changes significantly, and the changes depend, also, on speed of placing of electrodes on the skin, on degree and uniformity of their pressure.
Introduction of a certain constant delay between the primary contact of electrodes and skin and the beginning of measurement of free oscillations which result will be used later to search for special zones allows to level the said factors to a large extent.
The delay duration must be sufficient to establish a firm contact between the electrodes and the skin, but not too large to provide for measurement on the initial area of graphs on
Since this time is a few seconds, and the placing of the electrode on the skin from the first contact to dense pressing makes no more than 0.1-0.2 sec, it is reasonable to set the specified delay within 0.1-0.5 sec.
The averaging of the measured values allows to additionally reduce dependence on the subjective factors of the electrode placing.
As the measurements are not conducted continuously but at the rate of stimuli generation, then the minimum averaging time is the double period of the stimuli sequence (for paired averaging), and the maximum one should not exceed the time of formation of the t1 double layer.
Thus, the averaging time should be within a range between several hundredths of a second and one or even two seconds. Averaged values can be presented to a doctor for later comparison or can be saved in the device's memory.
In a homogeneous section of the body (back, stomach, shoulder, forearm, neck-collar zone etc.), the optimal zones for electropulse therapy are identified by extreme deviation of one of the parameters of free oscillation from the other electrode placing or by achievement of a certain criterion on their basis.
Thus, an area of skin with maximum (minimum) averaged duration of the first free oscillation (or its first half-wave, as described in RU Patent No. 2068277), or with maximum (minimum) averaged duration of one of the subsequent free oscillations, or with maximum (minimum) averaged number of free oscillations, or with maximum (minimum) change rate of the duration of the first free oscillation (or one of the subsequent oscillation) can be considered the optimal zone for electropulse therapy.
The skin area where the combination of measured parameters is reached can also be considered as the optimal zone for electropulse therapy.
More complex methods of zone identifying can be used on the basis of a predefined criterion—some predefined combination of values of measured (or averaged) oscillation parameters or the value of the oscillation parameter under certain condition.
For example, the criterion for selecting the optimal zone may be the maximum duration of the first free oscillation, with a minimum number of oscillations, or the maximum duration of the first free oscillation after the dynamics (change) of the oscillation has ceased.
As the proposed method for selecting optimal zones for the electropulse therapy uses extreme values of one of the free oscillations parameters, or reaching a certain criterion based on one or more oscillation parameters, then it is sufficient to indicate the moments of reaching the new extreme or the criterion rather than showing their values to a doctor.
In the simplest case, a doctor must memorize localization of only the last place where the extremes were reached, and it will be the optimal zone for the electropulse therapy.
If several zones with equal extreme parameter values are found, then in order to improve the efficiency of the therapy it is reasonable to treat not all of them, but only the so-called “small asymmetry” zones—the areas of skin surface which differ from the surrounding surface and which are small in relation to the entire surface treated (Gorfinkel, Y. (1996),
“Theoretical and practical basis for improving the effectiveness of SCENAR therapy,” SCENAR therapy and SCENAR Expertise collection 2: p. 16-18). The considered method of improving the effectiveness of therapy provides for the stimulation of only one of the found areas with equal extreme parameter values (or criterion), which is the smallest.
In the SCENAR therapy the labile stimulation is also applied, which facilitates the subjective determination of optimal zones for stimulation.
Therefore, the second variant is to search for special zones with the electrodes moved uniformly across the entire surface of the chosen skin area in one or more repetitions.
When the electrodes are moved on the skin, the same processes of double-layer formation occur, with the difference that new skin areas take part in the formation of the layer, while the treated ones are leaving the interelectrode space.
Thereby, the double-layer formation is not complete and the double-layer state is described as part of the graph on
In this case, the introduction of a constant delay between the electrode contact with the skin and the start of the measurement of free oscillations parameters will also allow to reduce the dependence of measured values on the subjective peculiarities of placing the electrodes on the skin.
After being firmly pressed on the skin the electrodes are moved within the selected zone.
When the size of the zone is significantly big (abdomen, back) then it is impossible to move the electrodes evenly on the entire surface with one movement.
The treatment of the zone with several movements of electrodes may also be provided for by methodological techniques.
In that case the surface is being treated with several movements in one direction (for example, from top to bottom) taking the electrodes off the skin and placing them back to the beginning of a new movement.
Introduction of a constant delay between the determination of the contact with the skin and the beginning of measurement of oscillations parameters when stimulating the zone in one or more repetitions allows to eliminate the error caused by non-uniformity of every placement of the electrodes on the skin.
The measurements can be conducted at the stimuli rate, whereas the indication, as in the first variant, can be only made when the new extreme or criterion is reached.
To reduce the error caused by the uneven movement of electrodes, resulting in uneven change of impedance of Rp, C and, consequently, uneven change of the parameters of free oscillations, it is useful to average the results of measurements.
The averaging can be carried out either with the several sequential measurements (simple averaging) or with a “sliding window” (moving averaging).
The labile method also applies the principle of “small asymmetry”, i.e. the impact on that identified zone with equal extreme parameter values, which is the smallest.
Both variants provide for the use of the combined electrode, containing both active and passive electrodes, as well as disjointed (separated) electrodes, where the active and passive electrodes are constructively separated. One of them is placed outside the zone selected for treatment, and the other is successively placed or moved within it.
The proposed method is performed as follows.
The electrodes are applied to the skin in the area close to the treatment zone, but outside of it.
The level of electrostimulation is set, for example, according to individual sensations, usually at a comfortable level.
The other electrostimulation parameters are also set manually or automatically in accordance with the selected therapy technique.
The method of searching optimal zones for electropulse therapy is chosen—sequential or labile.
During sequential method of treatment the electrodes are placed on the skin, and, 0.1 to 0.5 sec after the detection of contact with skin (by measuring the parameters of free oscillations caused by formation of dual-layer capacity, or by measuring the current flowing through the electrodes), the parameters of free oscillations are measured and averaged during a set period, for example, 1 second.
The stimulation is then stopped, and, in the simplest case, the doctor is provided with result of the measurement of oscillations parameters or the calculated value of the criterion.
The electrodes are then taken off the skin (the device is removed from the skin) and placed to the next point.
By comparing the received values (numerical or mnemonic, for example, the brightness of the glowing LED, or the number of LEDs glowing, or pitch of the sound tone, or the clicking sound rate), the doctor identifies the zones optimal for electropulse therapy.
In order to eliminate redundant information during the next successive placings of the electrodes, only the information about the achievement of a new extreme (or criterion) can be provided, whereas it is enough to indicate the end of the averaging time if no new extremes (or criterion) have been achieved at the new placing point.
The device itself can record the extreme zones by identifying them, for instance, with the sequential index of the electrode placing.
It is also possible to make a video recording of the electrodes application points and to link the measured values to them.
When computer is used for these purposes, the identification of zones optimal for electropulse therapy and their localization can be fully automated.
According to the results of the optimal zone identification, after searching through the entire chosen skin area, the main therapy is carried out, according to the chosen technique.
If several non-contiguous zones were found, then the smallest zone is considered optimal for electropulse therapy.
During the labile method of searching, after setting the individual level and parameters of electrostimulation as described above, the electrodes are placed on the skin area chosen for treatment and moved uniformly within it.
0.1-0.5 sec after detecting contact with the skin, the parameters of free oscillations are began to be measured, presenting the doctor the results of measurement or the calculated values of the criterion.
When direct measurements are used (without averaging), the elimination of redundant information is more important than during the sequential manner of treatment, that is why only the moments of achievement of the new extremes are indicated (in one of the above mentioned ways).
During the averaging of results (with one or another method), either all the results may be presented, or only the moments of achievement of the new extremes.
Since there is no link between the sequential index of the electrode placing point and the treatment area in this case, recording the data by device is ineffective and the doctor should remember the place of achievement of the new extreme.
All other ways of automating a sequential method of treatment (video recording or recording data and locations of the electrodes by a computer) are applicable to labile method.
According to the results of the optimal zone identification, after searching through the entire chosen skin area, the main therapy is carried out, according to the chosen technique.
If several non-contiguous zones are found then the treatment of the smallest zone is conducted.
The use of separated electrodes in both variants of a method is similar to the aforementioned, with the only difference that one of them is placed outside the treatment zone, whereas the search is carried out with the second electrode.
INDUSTRIAL APPLICABILITYThe group of inventions may be used in the treatment of various diseases, first of all, pain syndromes, regardless of their etiology, by stimulators which use inductive energy storage unit to generate stimuli and reduce the time of the procedures, improving the effectiveness of the treatment at the same time.
Claims
1.-6. (canceled)
7. A method for adaptive electric stimulation of a living body that includes applying electrodes on a biological object's tissues and transmitting through them bursts of electrical stimuli generated using an inductive energy storage unit made as an inductance coil or a transformer or an autotransformer, controlling an exposure duration and stimuli parameters based on parameters of free oscillations, arising in an oscillation circuit formed by an inductance of the storage unit and an impedance of interelectrode tissues, wherein the free oscillation parameters are measured while a current stimulus burst is acting and based on results of these measurements, one is controlling parameters of the stimuli in the same burst or in any subsequent stimulus bursts, as well as controlling an onset of a next stimulus in the burst depending on a phase of the free oscillation of a previous stimulus.
8. The method of claim 7, wherein the controlled stimulus parameter is a number of stimuli in the burst.
9. The method of claim 7, wherein the controlled stimulus parameter is a time interval between adjacent stimuli in the burst.
10. The method of claim 7, wherein the controlled stimulus parameter is a waveform, include an amplitude and polarity, of each stimulus in the burst.
11. The method of claim 7, wherein the controlled stimulus parameter is a repetition rate of subsequent stimulus bursts.
12. The method of claim 7, wherein the controlled stimulus parameter is an exposure duration.
13. A method for adaptive electric stimulation of a living body that includes applying electrodes on a biological object's tissues and transmitting through them bursts of electrical stimuli generated using an inductive energy storage unit made as an inductance coil or a transformer or an autotransformer, controlling an exposure duration and stimuli parameters based on parameters of free oscillations, arising in an oscillation circuit formed by an inductance of the storage unit and an impedance of interelectrode tissues, wherein one is measuring the free oscillation parameters of the last stimulus in a burst, and based on results of these measurements, one is controlling parameters of stimuli in any subsequent stimulus bursts, as well as is controlling an onset of a next stimulus in the burst depending on a phase of the free oscillation of a previous stimulus.
14. The method of claim 13, wherein the controlled stimulus parameter is a number of stimuli in the burst.
15. The method of claim 13, wherein the controlled stimulus parameter is a time interval between adjacent stimuli in the burst.
16. The method of claim 13, wherein the controlled stimulus parameter is a waveform, include an amplitude and polarity, of each stimulus in the burst.
17. The method of claim 13, wherein the controlled stimulus parameter is a repetition rate of subsequent stimulus bursts.
18. The method of claim 13, wherein the controlled stimulus parameter is an exposure duration.
19. A method for adaptive electric stimulation of a living body that includes applying electrodes on a biological object's tissues and transmitting through them bursts of electrical stimuli generated using an inductive energy storage unit made as an inductance coil or a transformer or autotransformer, controlling an exposure duration and stimuli parameters based on parameters of free oscillations, arising in an oscillation circuit formed by an inductance of the said storage unit and an impedance of interelectrode tissues, wherein at an end of a burst and before a beginning of a next burst, a probing stimulus is generated, wherein one is measuring parameters of free oscillations of the probing stimulus and, based on these measurements, one is controlling stimulus parameters in any subsequent stimulus bursts, as well as is controlling an onset of a next stimulus in the burst depending on a phase of the free oscillation of a previous stimulus.
20. The method of claim 19, wherein the controlled stimulus parameter is a number of stimuli in the burst.
21. The method of claim 19, wherein the controlled stimulus parameter is a time interval between adjacent stimuli in the burst.
22. The method of claim 19, wherein the controlled stimulus parameter is a waveform, include an amplitude and polarity, of each stimulus in the burst.
23. The method of claim 19, wherein the controlled stimulus parameter is a repetition rate of subsequent stimulus bursts.
24. The method of claim 19, wherein the controlled stimulus parameter is an exposure duration.
Type: Application
Filed: Feb 17, 2017
Publication Date: May 16, 2019
Applicant: RITM OKB ZAO (Taganrog, Rostov Region)
Inventors: Yakov Zalmanovich GRINBERG (Taganrog), Yury Yurievich STAROVOYTOV (Rostov-on-Don), Mikhail Anatolievich UNAKAFOV (Taganrog)
Application Number: 16/077,641
