Device for magnetic stimulation

Abstract

Disclosed is a device for magnetic action on living bodies to perform physiotherapy or stimulating effects on the tissues and internal organs of a human being or an animal to eliminate pain syndromes, stimulate the processes of vital activity and regeneration, accelerate tissue recovery after invasive effects and injuries. The device comprises an oscillator connected to an inductor including a bifilar coil made as a flat disk. Two coil windings formed as concentrically arranged spirals of adjacent wires of different windings are placed on a dielectric substrate. When attached to the skin surface, the device allows to expressly target pathogenic areas and organs located at 3-6 cm under the surface, while practically not affecting the tissues located near that surface. Suitable for clinical or home application, the device can be used for treating menstrual syndrome, hemorrhoids, joint diseases, for relieving pain of various etiologies, healing injuries, and stimulating cell proliferation.

Claims

1-9. (canceled)

10. A device for magnetic effect on living bodies, comprising: an oscillator and an inductor connected thereto, the oscillator operating at the resonant frequency of the inductor, the inductor being made in the form of a flat bifilar coil with open-circuit windings, connected to the oscillator as a load in the form of a series-oscillatory circuit, providing a sinusoidal shape of the output current at the resonant frequency of the coil, wherein the bifilar coil is made in the form of a flat disk, in which the wires of the coil windings are placed on a dielectric substrate in the form of two concentrically arranged spirals from two adjacent wires of different windings, wherein an open-circuit terminal of one of the windings of the bifilar coil is located at the inner end of the one winding in the radial direction of the coil, and an open-circuit terminal of the second of the windings of the bifilar coil is located at the outer end of the second winding in the radial direction of the coil, and opposite terminals of the both coil windings are connected to corresponding terminals of the oscillator.

11. The device according to claim 10, wherein the inductor is structurally combined with the oscillator.

12. The device according to claim 10, wherein the windings of the bifilar coil are made as two identical wires wound in the same plane tightly to one another, with total thickness of the windings equal to one wire diameter.

13. The device according to claim 10, wherein the windings of the bifilar coil are made as two identical wires tightly wound one above the other, with total thickness of the windings equal to two wire diameters.

14. The device according to claim 10, wherein the oscillator includes a self-excited oscillator of sinusoidal or square oscillations with a coil in the circuit of the positive current feedback.

15. The device according to claim 10, wherein the oscillator includes a self-excited oscillator of sinusoidal oscillations with a coil in the circuit of the positive current feedback with amplitude modulation or manipulation.

16. The device according to claim 10, wherein the oscillator is equipped with the circuit of the negative voltage feedback with the ability to control the magnitude of the output voltage and, accordingly, the output current and intensity of the magnetic field generated by the inductor by changing the depth of the negative voltage feedback.

17. The device according to claim 10, wherein the oscillator includes a voltage-controlled oscillator with a phase-locked loop.

18. The device according to claim 10, wherein the resonant frequency of the bifilar coil, as a series-oscillatory circuit, and the frequency of the oscillator is set in the range of 250-380 kHz.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The essence of the invention is explained with the drawings, where

[0030] FIG. 1 provides a design view of the inductor, made in the form of a flat bifilar coil,

[0031] FIG. 2—electrical diagram of the windings of the flat bifilar coil,

[0032] FIG. 3—the connection diagram of the power supply, oscillator and inductor,

[0033] FIG. 4—general view of the oscillator and the inductor, made, respectively, in the form of a round device and a flat disk,

[0034] FIG. 5—diagram, representing the shape of generated magnetic field intensity,

[0035] FIG. 6—diagram of the bifilar coil magnetic field intensity distribution along its vertical and horizontal axis,

[0036] FIG. 7—functional diagram of the oscillator in the form of self-excited oscillator with a bifilar coil in the PCFL circuit;

[0037] FIG. 8—stress distribution diagrams at test points T1, T2 of self-excited oscillator with the PCFL;

[0038] FIG. 9—functional diagram of the oscillator in the form of self-excited oscillator with AFC,

[0039] FIG. 10—stress distribution diagrams at the test points T1, T2 and T3 in the position S1-1 of S1 switch of the generator with a AFC,

[0040] FIG. 11—stress distribution diagrams at test points T1, T2 and T3 in the position S1-2 of switch S1 of the generator with a AFC.

[0041] Items and letters marked at the drawings: 1—the first (closed-circuit) terminal of the first winding; 2—the second (open-circuit) terminal of the first winding; 3—the third (open-circuit) terminal of the second winding; 4—the fourth (closed-circuit) terminal of the second winding; 5—L1—inductor's bifilar coil; 6—substrate; 7—the first winding of the bifilar coil; 8—the second winding of the bifilar coil; 9—oscillator; 10—power supply; 11—inductor housing; 12—oscillator housing; 13—connecting cable for inductor connection to the oscillator; 14—bifilar coil axis; 15—oscillator node; Di—internal diameter of the bifilar coil; Do—outer diameter of the bifilar coil; K1, K2—generator terminals; A1—generator node (self-excited oscillator); DA1—amplifying stage covered with feedback communication; R1, R2, R3—resistors; +IN, −IN—amplifying stage input terminals; OUT—amplifying stage output terminals; AFC—automatic frequency control; LPF—low pass filter; S1—AFC output voltage form switch; S1-1, S1-2—S1 switch positions; PD—phase detector; VCO—voltage controlled oscillator; T1—self-excited oscillator output voltage test point; T2—coil output current test point; T3—AFC output voltage test point, U1—oscillator/self-excited oscillator output voltage, U2—the voltage at the current transducer, U3—AFC output voltage.

DETAILED DESCRIPTION OF THE INVENTION

[0042] Flat bifilar coil 5 of the inductor is formed by two identical conductors, also called winding wires, wound in two wires in a single layer in the same plane, in the form of a flat spiral from the inner diameter Di to the outer diameter Do, with firm adherence of adjacent conductors and adjacent winding turns to each other without gaps between them. Adjacent conductors form, respectively, the first winding 7 and the second winding 8 of the flat bifilar coil 5. Windings 7, 8 can be wound with a single-core or multi-core winding wire with enamel or lacquer insulation. The thickness of the bifilar coil 5 is equal, respectively, to the thickness of one winding wire. Windings 7, 8 of the bifilar coil 5 can be made as helical winding in one plane with two identical wires put together with vertical arrangement of the winding wires, i.e. perpendicular to the plane of its winding, with “two wires—to two wires” connection to each other, while ensuring the total thickness of the winding equal to two diameters of the winding wire. Bifilar coil 5 can also be made as two flat windings with the thickness of one wire, located with their planes opposite and parallel to each other on different sides of the substrate, i.e. with the separation of both windings of the coil with the substrate. The first winding 7 of coil 5 has the first terminal 1 and the second terminal 2. The second winding 8 of coil 5 has, respectively, the third terminal 3 and the fourth terminal 4. The second and the third terminals 2, 3 of coil 5 are open-circuit. Open-circuit terminal 2 of the first winding 7 of coil 5 is located at the internal end of the specified winding in the radial direction of the coil and open-circuit terminal 3 of the second winding 8 of coil 5 is located at the outer end of the specified winding in the radial direction of the coil. It is possible to have reverse location of open-circuit terminals of coil 5, when the open-circuit terminal 2 of the first winding 7 of coil 5 is located at the outer end of the specified winding in the radial direction of the coil, and the open-circuit terminal 3 of the second winding 8 of coil 5 is located at the inside end of the specified winding in the radial direction of the coil. The first (closed-circuit) terminal 1 of the first winding 7, located at the outer end of the specified winding in the radial direction of coil 5, and the fourth (closed-circuit) terminal 4 of the second winding 8, located at the inner end of the specified winding in the radial direction of coil 5, are normally connected to the signal source or self-excited oscillator circuit with two-wire cable. Windings 7, 8 of bifilar coil 5 are located at flat substrate 6 in the form of a round plate made of a dielectric material, such as, for instance, plastic or wood. At that, terminal 1 of the first winding 7 and terminal 4 of the second winding 8 are led outside the substrate 6 for their connection with terminals K1, K2 of the oscillator 9, and the opposite open-circuit terminals 2 and 3 of the specified windings are embedded in the substrate 6 and not projected outside the coil.

[0043] In electrical equivalent, coil 5 is series-oscillating circuit. In the embodiment of invention shown in FIG. 3, 4, the coil is structurally separated from the oscillator, the first terminal 1 and the fourth terminal 4 of coil 5 are connected to the voltage outputs K1 and K2 of the oscillator 9. Oscillator 9 is connected to DC power source 10 which is a rechargeable battery.

[0044] Depending on the embodiment of the device for magnetic effect, the oscillator and the coil can be combined in a common housing; the generator can be powered from the AC network via an AC or DC adapter.

[0045] On the inductor housing (or on the housing of device containing the inductor) there may be provided attachments to the user's clothing in the area of desired magnetic stimulating or therapeutic effect to avoid the need to hold the device in the course of operation.

[0046] Coil 5 inner diameter Di principally determines the diameter of the toroid formed in the top of the cone generated by coil 5 of the magnetic field inductor due to the interference of separate magnetic fields generated by each turn of winding of bifilar coil 5.

[0047] Oscillator 9 schematically can be a generator with manual resonance frequency tuning or self-excited oscillator with PCFL or voltage controlled oscillator with a AFC, and the inductor is series-oscillating circuit being the load of the specified generator, inducing magnetic oscillations.

[0048] The claimed device works as follows.

[0049] Oscillator 9 supplies voltage to coil 5 with at the resonance frequency of the coil, the self-excited oscillator automatically operates at the resonance frequency of the coil. Due to field density multiplication cone-shaped form of the magnetic field is achieved with the maximum intensity at the top of the cone due to turns density reduction from the center to the edge of coil 5. At that, the height of the cone above coil 5 surface depends on the coil diameter and the strength of induction current through the coil.

[0050] Table 1 shows the values of the magnetic field induction measured along the mutually perpendicular directions N, W, E, S in the plane of coil 5.

TABLE-US-00001 TABLE 1 Displacement from the center, cm N S W E 0 4 4 4 4 1 4 4 4 3.6 1.5 3.8 3.6 3.8 3 2 3 3 3.4 1 3 2 2 2 1 4 1 1 1 1

[0051] Table 2 shows the magnetic field induction values measured along the mutually perpendicular directions N, W, E, S at 5 cm distance from the coil plane.

TABLE-US-00002 TABLE 2 Displacement from the center, cm N S W E 0 5.4 5.4 5.4 5.4 1 5 5.6 5 5.4 2 4.6 5.4 4.6 5 3 4 5.2 4 4.6 4 3.4 4.8 3.4 4 5 1 4.2 2 3 6 1 3.6 2 2.8 7 1 3 2 2 8 1 1 1 2 9 1 1 1 1

[0052] The shape of the distribution of the magnetic field strength of coil 5 has the characteristic frusto-conical shape and in projection on the base plane reflects the features of its winding.

[0053] The resonance frequency of the series-oscillating circuit implemented in the claimed device in the form of bifilar coil 5 is determined by coil 5 parameters, in particular its geometric dimensions, number of turns of its windings, internal and external diameter of the windings, as well as the diameter (cross section) and length of the winding wire. The length of the wire of selected section is determined by the size of the coil, the winding method, and the number of turns.

[0054] Coils of different sizes can cause comparable therapeutic effect, and the most significant in terms of achieving stimulating and therapeutic effect is the directional form of obtained magnetic field, as well as its frequency and intensity value. In this case, most of the above parameters are determined by the geometric parameters of the inductor coil 5. Excitation of oscillations, and, respectively, generation of a magnetic field with the inductor, occurs at the resonance frequency of coil 5 of the inductor. Coil current oscillations have sinusoidal shape. In order to stabilize oscillations and to reduce nonlinear distortions, the circuit can additionally be covered with the NVF circuit.

[0055] Thus, the oscillating circuit, executed as bifilar coil with open-circuit turns, acts both as frequency-setting element and at the same time as an inductor loading the oscillator.

[0056] The resonance frequency of the oscillation circuit formed by the inductor coil is 250-380 kHz, preferably 280-350 kHz. The specified frequency range is the frequency range determined on the basis of performed research as the most effective and safe range of operating frequencies of generated magnetic impact in order to ensure the best and stable stimulating and therapeutic effect.

[0057] Due to the effect of oscillating magnetic field, in the specified range of oscillation circuit resonance frequencies, the most represented and stable magnetic stimulating and therapeutic effect is provided, consisting in elimination of pain syndromes, stimulation of life processes and regeneration, accelerating the recovery of human and animal tissues after invasive effects and injuries.

[0058] The oscillator is designed with a possibility to regulate the output voltage and, respectively, the values of output current and intensity of magnetic field, generated by the inductor. The oscillator can also be provided with means for regulating duration, number of cycles or frequency of repetition of generated magnetic impact, as well as its modulation and manipulation with low-frequency signals.

[0059] Impact intensity can be pre-set by the oscillator parameters and set in the range most effective and safe for the user, ranging from 80 μT to 200 μT, and, in this case, only regulation of impact duration can be provided. Executed experiments have shown that magnetic impact generated by the inductor of the present invention with the magnetic field intensity in the range from 80 μT to 200 μT provides achievement of stable therapeutic effect, while the intensity of the magnetic field in the plane of the inductor remains comparable with the value of the Earth magnetic background, comprising about 50-60 μT, which provides a minimal impact on human tissues and organs surrounding the impact area, and thus also excludes the occurrence of undesirable thermal effect.

[0060] Oscillator execution as self-excited oscillator simplifies the implementation of the claimed device and provides automatic excitation of oscillations in the inductor coil at its resonance frequency.

[0061] Magnetic field shape, provided by the claimed device, enables to perform directed magnetic stimulating effect on human tissues and organs located directly under the application site of the inductor at up to 6 cm depth from the surface of the body. Exposure to such magnetic field by applying the specified inductor to areas of the body located above pathogenic areas, in particular over painful organs within 15-30 minutes, provides directed “local” effect on the areas of the body exposed to magnetic impact with pain management for a long period of time. At that, the shape of the magnetic field of the claimed device allows to actually eliminate the main side effect of the magnetic field in the course of application of known state-of-the-art devices on healthy tissues surrounding the target area, in particular, magnetic stimulation, which can sometimes cause development of new pathologies or escalation of existing ones. This disadvantage is eliminated due to application of “focused” magnetic field with the maximum of its intensity, concentrated at the top of the “magnetic cone”, i.e. limited to a small area of “directed” influence.

[0062] A series of experiments with the claimed device proved that the therapeutic effect of eliminating or reducing pain syndromes of various etiologies is achieved primarily due to the properties of inhomogeneous and directed magnetic field applied. 250-380 kHz range of resonance frequencies, determined by the results of experiments, as well as 80-200 μT range of magnetic field intensity, allow obtaining even more significant magnetic stimulating and therapeutic, in particular, pain relieving effect, without the danger of local heating of adjacent tissues.

Example 1. Testing on the Proliferation Model

[0063] The study was conducted at the “Scientific center of cytogenetic testing” LLC in January, 2019.

[0064] The device was tested at different device capacities, namely, at 50% (90-100 μT) and 100% (180-200 μT), and at different distances (0 cm and 4 cm) in order to determine the effect of the device on the proliferation of cells of the CHO-K1 line.

[0065] The cells were plated at the rate of 200 μl of medium per well of a 96-well plate. The medium comprised 9 parts of the DMEM (or EMEM) substrate with addition of 1 part of the embryonic veal blood serum. Cells suspension with 2×104 cells/ml seeding concentration was prepared. To do this, culture flasks (25 cm.sup.2 or 75 cm.sup.2 in area) with formed cells monolayer (2-4 days cell culture with normal cell morphology) were selected; the cell monolayer was dispersed: 2-5 ml of substrate was added to the culture flask; the contents of the flask were mixed with a 10 ml pipette; a sample was taken and the cell suspension was transferred to Eppendorf type microcentrifuge tube. Then the concentration of cells was calculated in Goryaev chamber. Cell suspension was diluted with substrate to required final cell concentration. 0.2 ml cell suspension of was added to the required number of wells (based on the number of samples studied) in two 96-well plates. The plates with cells were incubated for three days at 37±0.5° C. in an atmosphere with 5±0.7% CO2 content at different shelves of the incubator. At that, the control plate was placed on a shelf, and the test plates were placed strictly in the middle directly opposite operating magnetic impact device at 4 cm distance from the surface, using plastic tubs or tripods as lifting facility. This arrangement was repeated with 50% and 100% capacity of activated device. Upon completion of the incubation period, the plates were removed from the incubator, the substrate was completely removed from the wells, 100 μl of trypsin-versene solution (1:9) was poured and left for 10-15 minutes to completely detach the cells from the substrate. The content of the well was mixed with a dispenser and 10 μl were added to Goryaev chamber. The cells were counted cornerwise in five large squares. The obtained number was multiplied by 1.25 and 104 co-efficient, and thus determined the number of cells in ml. The procedure was repeated for each well. Then the proliferation index (PI) was calculated as the ratio of cells concentration after three days of cultivation to the seeding concentration. PI for control and test were calculated separately. Then the Impact index was calculated as the ratio of test and control options, using the following formula: ((test IP/control IP)*100−100).

[0066] Test results proved that proliferation increases by 7-40%, depending on exposure power and the distance from the plate to the device.

Example 2. Testing on the Wounds Model

[0067] Testing to determine the specific activity of the device on the wound model (“wound healing assay”). Wound model in vitro is widely used technique for evaluation of cells mobility and migration rate. In the course of experimental wound healing different types of cells react in a similar way: the cells polarize, form protrusions towards the wound, and migrate (Yarrow et al., 2004). The study was conducted at the “Scientific center of cytogenetic testing” LLC in compliance with the standard protocol for this procedure.

[0068] The study demonstrated the increase of “wound” healing rate in case of application of the device according to the invention on cell culture by 12%.

Example 3. Treatment of Hemorrhoids

[0069] In February 2019, the device was tested in St. Petersburg at private clinics on men with symptoms of hemorrhoids of 3-4 degrees (20 people aged from 30 to 60 years). The tests were aimed at studying the effect of relieving pain and other senses of discomfort. Magnetic therapy sessions were conducted within 14 days for 30 minutes each day at a radiation intensity of 180-200 μT (100% of the device's capacity). This intensity of the magnetic field eliminates the occurrence of undesirable side effects, in particular, the thermal effect. The magnetic disk was applied by the patient to the area of maximum pain. Selected group included both patients using additional medications and patients not receiving pharmaceutical treatment. All patients, participating in the study, described the disappearance of characteristic pain on the day 2-3 after commencement of the study; in some cases, arrest of hemorrhage was noted in acute forms of the disease, and tumorous and edematic phenomena reduction upon completion of therapy in 14 days. In each case, the proctologist conducted an objective examination before and after magnetic therapy sessions, which confirmed the subjective feeling of remission.

Example 4. Treatment of Prostatitis

[0070] In February, 2019 the device was tested on men with prostatitis symptoms at private clinics in Saint Petersburg. 20 men aged from 40 to 60 years participated in the study. The magnetic disk was applied by the patient to the area of maximum pain. Selected group included both patients using additional medications and patients not receiving pharmaceutical treatment. As a result, a positive effect of pain reduction subjective perception was observed within 10-14 days according to the described method. Objective confirmation of the test result was based on laboratory analysis of lymphocytes number in special effusion, which demonstrated lymphocytes number decrease by 12-15% as a result of magnetic device application. It is assumed that the impact efficiency can be significantly increased in case of implementation of direct access to the hotbed of disease by means of changing the design parameters of the device, resulting in increase of active magnetic field intensity in the pathology zone.

Example 5. Menstrual Pain Syndrome

[0071] The study was also conducted in February, 2019 at private clinics. 50 women aged from 18 to 24 years with menstrual pain syndrome voluntarily participated in the study. Magnetic therapy sessions were conducted within 2-4 days for 30 minutes each day at 180-200 μT radiation intensity (100% of the device capacity). The study revealed positive dynamics based on subjective feelings of more than 60% of participants already on the second day of device application. To objectify the assessment, it is required to clarify the diagnosis, for example, endomitriosis or polycystic ovary, etc. In each of examples 3-5 none of the patients had any adverse events that could be associated with device application. Reexamination of patients in 2-3 months demonstrated that the aftereffect duration upon completion of the magnetic therapy session is 30-45 days in 54% of the subjects.

[0072] Thus, the claimed device allows to exercise targeted magnetic stimulating effect expressly on pathogenic areas and organs located at 3-6 cm depth from the skin surface, while practically not affecting the tissues located on and near the skin surface, to which the inductor (applicator) coil is attached. The shape of the magnetic field of the inductor, made in the form of the bifilar coil, provides an impact on specified areas in order to localize pain of various etiologies.

[0073] Main characteristics of the claimed device: [0074] inductor output current effective value 0.01-2.00 A; [0075] oscillator output voltage effective value 1.5-10V; [0076] induced magnetic field intensity—80-200 μT.

[0077] Device design features and portability allow to “deliver” the magnetic impact signal to the target area of the human body locally, as well as, if required, affect multiple foci and central processes. Thus, the claimed device comprises a compact device for general medical purpose magnetic stimulation, suitable for application in clinical or home conditions for treatment of menstrual syndrome, hemorrhoids, joint diseases, as well as for relieving pain of various etiologies and for healing injuries and stimulating cell proliferation.