WO2024010488A1

WO2024010488A1 - Device for non-invasive electrical stimulation of body tissues

Info

Publication number: WO2024010488A1
Application number: PCT/RU2023/000197
Authority: WO
Inventors: Stanislav Lvovich Bugrov; Tatyana Anatolyevna BUGROVA; Nikita Andreevich PEREVALOV
Original assignee: Stanislav Lvovich Bugrov
Priority date: 2022-07-06
Filing date: 2023-07-05
Publication date: 2024-01-11
Also published as: CN117357786A

Abstract

The invention relates to means for meeting the needs of life, more specifically, to electrically stimulating devices. It can be used for manufacturing various consumer products, for example, personal items (toothbrushes, combs, massagers, razors, plasters, tights, chains worn next to the skin, etc.) or eating utensils (wineglasses, spoons, forks, chopsticks, etc.). The device for non-invasive electrical stimulation of body tissues comprises cathode and anode parts connected into a direct current electrical circuit and a unit for breaking said circuit, located therebetween. The cathode and anode parts are made from materials having different electronegativity that form a galvanic pair. The breaking unit is made in the form of a mechanical breaker equipped with a body and an inertial oscillating element configured to open and close the said circuit periodically under the action of external forces. The body of the mechanical breaker is made hollow and the inertial oscillating element is located inside the body. The body comprises conductive parts which are connected via a dielectric, provided that the mechanical breaker is of a kinetic type. The body comprises conductive contact pads which alternate with dielectric inserts, provided that the mechanical breaker is of a gravitational or rotational types. The invention provides non-invasive electrical stimulation of body tissues and expands the functionality of the electrostimulating device by virtue of operation in a pulsed DC mode without an additional current source.

Description

DEVICE FOR NON-INVASIVE ELECTRICAL STIMULATION OF BODY TISSUES

The invention relates to means for meeting the needs of life, more specifically, to electrically stimulating devices. It can be used for manufacturing various consumer products, for example, personal items (toothbrushes, combs, massagers, razors, plasters, tights, chains worn next to the skin, etc.) or eating utensils (wineglasses, spoons, forks, chopsticks, etc.).

Metals with different electrochemical potentials, such as gold and zinc, are able to form a galvanic pair which produces voltage of an electrochemical system (EMF) in the result of potential-forming electrochemical reactions (V.N. Varypaev, M.A. Dasoyan, V.A. Nikolskiy "Chemical current sources" - M.: The Higher School, 1990).

A device and method are known from the prior art (RU 2686427, cl. A61N 1/26, A61M 5/46, A61M 37/00, publ. 25.04.2019), which promote hair growth and/or prevent hair loss by virtue of rolling over a scalp and piercing the skin no deeper than the thickness of dermis and by depositing metal ions in the skin. The device comprises a housing, which is connected to a current source by means of a handle, and a plurality of parallel discs configured to roll over the scalp. The discs are covered with a metal and/or made from a metal: copper and/or zinc. Each disc comprises an array of stimulating elements (needles) located around the circumference of the discs. Each penetration of the scalp skin involves deposition of metal ions in the skin, which is performed for at least 0.01 second and at most 0.1 second. According to some embodiments of this solution, the stimulation comprises supplying an alternating current in order to deposit copper ions and zinc ions alternatively under the skin, wherein the waveform of the alternating current is selected according to a desired ratio of deposition of copper and zinc ions.

This known solution has the following disadvantages: it requires an external current source to generate an electric current in the circuit and to set a suitable waveform and mode of the current; the device does not use galvanophoretic effect capable to provide more efficient penetration of non- invasive therapeutic and/or nutritional agents into body tissues.

Further, a device and method for physiotherapy are known from the prior art (RU 2215555, cl. A61N 1/30, publ. 10.11.2003), relating to the medicine area. They can be used for obtaining metal ions and for treating biological objects with these metal ions (including an implementation of iontophoresis treatment), without the necessity to apply an external electric field. The device consists of two short-circuited electrodes made of different metals or metal compounds, which are chemically inactive to an electrolyte. Water and secretion of the skin or mucous membranes are used as the electrolyte. There exists a contact potential difference between the electrodes. Upon contact with the electrolyte, ions are released from the electrode. The procedure of iontophoresis consists in applying the device to the skin or mucous membranes of a patient so that counter-forces are formed between similar charges, which involve the ions into a directional motion.

The disadvantages of this solution are as follows: the device is incapable to set the waveform and mode of the current in the circuit; also, the device does not use the galvanophoretic effect which would be able to provide more efficient penetration of non-invasive therapeutic and/or nutritional agents into body tissues.

Further, an iontophoretic patch is known from the prior art (WO 9727899 Al, cl. A6 IN 1/30, A61N1/32, published 31.07.2003). The solution is aimed to provide an electrotherapeutic effect, such as iontophoretic delivery of drugs at an operating frequency range 0.0027 - 10 Hz of an electric current.

The disadvantage of this solution is in that the iontophoretic patch requires an external current source to perform the galvanophoresis and to set the form and mode of the current. A comb is known from the prior art (WO 9704731 A2, cl. A61H7/00; A6 IN 1/32; A61N2/06; publ. 13.02.1997), intended to be used for massage and electrotherapy. It comprises a body provided with conductive massage elements and with a handle, which form a galvanic pair. In one embodiment of the device, the massage elements themselves can structurally form a galvanic couple. The device may comprise an alternating current source and means for changing a form of the signal and operating modes. In a particular case, the device may comprise an electrical switch which is arranged between the current source and the surfaces of the electrodes and configured to bring the conductive massage elements into short-circuit contact.

The disadvantages of this solution are as follows: the device is not able to operate in a pulsed mode; the device does not use the galvanophoretic effect capable to provide more efficient penetration of non-invasive therapeutic and/or nutritional agents into body tissues.

The closest prior art to the instant invention, as regards the technical essence, is a toothbrush (RU 2183439, cl. A61C 17/16, A61N 1/20, A46B 9/04, publ. 20.06.2002) comprising cathode and anode parts, which are connected to form a direct-current electrical circuit, and a unit for breaking the circuit, which is located between said parts and made in the form of a relay. The cathode and anode parts are conductive elements, and the electrical circuit which they are connected to is equipped with a direct current source. The first conductive element is electrically connected to the positive pole of the current source and located on the handle, while the second element is electrically connected to the negative pole of the current source and located in the bristle area. The toothbrush can be equipped with a current limiter and a LED indicator, which are connected in series with the negative pole of the current source. A microbattery is preferably used as a power source for the electronic circuit.

The disadvantage of the known solution is that the breaker (relay) is configured to switch operating modes from operating with the external current source to operating in a short-circuit mode, but it is not designed to carry out a pulsed mode. Therefore, the interruption of a direct current can be performed only at a moment of switching the modes. In addition, the operation of this known device requires a separate power source (battery), which fact sufficiently complicates the design and manufacture of the device, and also limits the period of its operation without maintenance.

Thus, the technical problem of the instant invention is to overcome the above disadvantages and to create a device capable of operating in a pulsed DC mode without an additional current source.

The technical effect consists in expanding the functionality of the device.

The problem is solved and the technical effect is achieved by providing the claimed electrostimulating device comprising cathode and anode parts connected into a direct current electrical circuit and a unit for breaking said circuit, located therebetween, wherein the cathode and anode parts are made from materials having different electronegativity that form a galvanic pair, while the breaking unit is made in the form of a mechanical breaker equipped with a body and an inertial oscillating element configured to open and close the said circuit periodically under the action of external forces during the operation of the device.

The device is preferably configured to interrupt the circuit with a frequency of 0.5-20 Hz, and the galvanic couple is configured to produce an EMF of 0.4-2.8 V in the circuit.

The cathode part of the device can be made from gold, platinum, silver, graphite or palladium, while the anode part from zinc, magnesium, lithium or their alloys. The device can be made in the form of a dielectric blank, on which the cathode and anode parts are arranged in the form of a metal coating.

The body of the mechanical breaker can be made hollow and comprises first and second conductive parts connected via a dielectric, and the inertial oscillating element can be located inside the body. The first conductive part of the body of the mechanical breaker is connected to the cathode part of the device, while the second conductive part of the body of the mechanical breaker is connected to the anode part of the device.

The inertial oscillating element preferably comprises a fixture element, a contact element and a rod connecting the elements, all of them are conductive, wherein the fixture element is connected to the first conductive part of the body, and the rod and the contact element are configured to involve periodically the contact element and the second conductive part of the body into contact with each other during oscillation under the action of external forces.

In one version of the inertial oscillating element, the fixture element and the contact element are made in the form of cone-shaped spirals with different maximum diameters, which apexes are connected to the rod. In another version, the fixture element is made in the form of a cylindrical spiral, and the contact element is made in the form of a prolongation of the rod, curled into a spiral or ring.

It is also possible to perform the mechanical breaker having the fixture element in the form of a prolongation of the rod and the contact element in the form of a load weight, wherein a collar is arranged on the inner wall of the second conductive part of the body, a flexible resilient additional contact element is mounted on the collar, the element is configured to oscillate under the action of external forces during the operation of the device and it is electrically isolated from the inertial oscillating element when said forces are absent. The additional contact element can be made in the form of a cylindrical spiral, and a dielectric insert can be located between the rod and the additional contact element.

The construction of the device also covers other variants of the inertial oscillating element.

For example, the body of the mechanical breaker can be made in the form of a hollow cylinder in which the inertial oscillating element in the form of a conductive ball is arranged, the diameter of the ball is less than the inner diameter of the cylinder and equal to the height of the cylinder cavity, wherein the conductive contact pads are arranged in the central part of the inner wall of the cylinder, which are separated by dielectric inserts and alternatively connected to the cathode and anode parts of the device.

In accordance with another embodiment, the body of the mechanical breaker is made in the form of a hollow outer cylinder, and the inertial oscillating element is made in the form of an inner cylinder located inside the outer cylinder with the ability of coaxial rotation, wherein the conductive contact pads are located on the inner wall of the outer cylinder and on the outer wall of the inner cylinder, the pads being alternated with dielectric inserts.

Fig.l illustrates a general view of the claimed electrostimulating device made in the form of a toothbrush;

Fig.2 illustrates the same in the form of a comb;

Fig.3 illustrates the same in the form of a roller massager;

Fig.4 illustrates the same in the form of a stick massager;

Fig.5 illustrates the same in the form of a razor;

Fig.6 illustrates the same in the form of a plaster;

Fig.7 illustrates the same in the form of a wineglass;

Fig.8 illustrates the same in the form of a spoon;

Fig.9 illustrates a pair of electrically stimulating devices in the form of chopsticks;

Fig.10 is a scheme showing an interaction of a user with the claimed electrostimulating device;

Fig. 11 illustrates a kinetic mechanical breaker equipped with a fixture element and a contact element, which are made in the form of cone-shaped spirals;

Fig.12 illustrates a kinetic mechanical breaker equipped with a fixture element made in the form of a cylindrical spiral and with a contact element made in the form of a prolongation of a rod curled into a spiral or ring;

Fig.13 illustrates a kinetic mechanical breaker equipped with a fixture element made in the form of a prolongation of a rod and with a contact element made in the form of a load weight;

Fig.14 is a pan view of a gravitational mechanical breaker;

Fig. 15 is a side view of the gravitational mechanical breaker;

Fig. 16 illustrates a rotational mechanical breaker;

Fig.17 is a plot illustrating the rate (1/t) of penetration of non-invasive therapeutic and/or nutritional agents into body tissues as a function of the frequency of interruption of the DC circuit.

The claimed electrostimulating device (Fig.l - 9) is formed by a dielectric blank 1 with cathode 2 and anode 3 parts. The parts 2 and 3 are connected into a DC electric circuit, made from materials having different electronegativity, i.e. having different electrochemical potentials (such as gold and zinc), and constitute a galvanic pair that generates a voltage in the electrical circuit, i.e. a voltage of the electrochemical system (EMF). This voltage is in the amount of 0.4 to 2.8 V and it is occurred due to the potential-forming electrochemical reactions.

The following half-reactions correspond to the Galvanic contact “gold (Au) - zinc (Zn)”:

Red (Au): O₂ + 2 H₂O + 4e 4OH”, E° = +0.401 V,

Ox (Zn): Zn + 4OH~ - 2e ZnO₂ ² + 2H₂O, E" = 1.216 V. wherein E° - standard electrode potential of a half-reaction, EMF is amount to 1.616 V.

The following half-reactions correspond to the Galvanic contact “gold (Au) - magnesium (Mg)”: Red

E° = +0.401 V,

Ox (Mg): Mg - 2e Mg ²⁺, E° = -2.363 V, wherein EMF is amount to 2.763 V.

A breaking unit in the form of a mechanical breaker 4 is arranged between parts 2 and 3, which acts to open and close the circuit periodically under the action of external mechanical forces during the operation of the device with a frequency of 0.5-20 Hz. In the process of operating the device, the cathode 2 and anode 3 parts are connected to each other on one side via the mechanical breaker 4 and on the other side via a living biological object (user’s tissue) (Fig.10).

The device can be made both in the form of the dielectric blank 1, on which the cathode 2 and anode 3 parts are applied in the form of metal coatings, and entirely from materials having different electronegativity (different electrochemical potentials). The cathode part of the device can be made from gold, platinum, silver, graphite or palladium, while the anode part can be made from zinc, magnesium, lithium or their alloys.

In the kinetic version (Fig.11 - 13), the mechanical breaker 4 of the claimed device comprises a body 5 and an inertial oscillating element 9. The body 5 of the mechanical breaker 4 is hollow and comprises first 6 and second 7 conductive parts connected via a dielectric 8. The inertial oscillating element 9 is located inside the body 5. The first conductive part 6 is connected to the cathode part 2 of the device, while the second conductive part 7 is connected to the anode part 3 of the device.

In one embodiment of the kinetic mechanical breaker (Fig.l 1) the inertial oscillating element 9 comprises a conductive fixture element 10, a contact element 12 and a rod 11 connecting said elements. The fixture element 10 is connected to the first conductive part 6 of the body 5, whereas the rod 1 1 and the contact element 12 are configured to involve periodically the contact element 12 and the second conductive part 7 of the body 5 into contact with each other, in the course of oscillation caused by external mechanical forces during the operation of the device. The fixture element 10 and the contact element 12 are made in the form of cone-shaped spirals with different maximum diameters dl and d2, respectively, which apexes are connected to the rod 11.

According to other embodiment of the kinetic mechanical breaker (Fig.12), the fixture element 10 is made in the form of a cylindrical spiral, while the contact element 12 is made in the form of a prolongation of the rod, curled into a spiral or ring.

In another embodiment of the kinetic mechanical breaker (Fig.13), the fixture element 10 is made in the form of a prolongation of the rod 11, while the contact element 12 is made in the form of a load weight. An annular collar 13 is provided on the inner wall of the second conductive part 7 of the body 5, on which a flexible resilient additional contact element 14 is mounted. The element 14 is configured to oscillate under the action of external mechanical forces during the operation of the device, it is electrically isolated from the inertial oscillating element 9 by means of a dielectric insert 15.

In the gravitational version (Fig.14, Fig.15) the body 5 of the mechanical breaker is made in the form of a hollow cylinder, inside which an inertial oscillating element 9 in the form of a conductive ball is located. Conductive contact pads 16 are arranged in the central portion of the inner wall of the body 5, which are separated by dielectric inserts 17 and alternatively connected to the cathode 2 and anode 3 parts of the device.

In the rotational version (Fig.16), the body 5 of the mechanical breaker is made in the form of a hollow outer cylinder, while the inertial oscillating element 9 is made in the form of an inner cylinder located inside the outer cylinder with the ability of coaxial rotation. Conductive contact pads 16 are arranged on the inner wall of the body 5 and on the outer wall of the inertial oscillating element 9, which alternate with dielectric inserts 17.

The claimed device in the version provided with a kinetic mechanical breaker 4 (Fig.11 - 13) operates in the following manner.

In a non-operating mode of the device, the cathode 2 and anode 3 parts, connected into the DC electrical circuit, are open. Under the action of a periodic external mechanical force applied to the device during its operation, for example, when combing, brushing teeth, etc., the device switches to a pulsed mode of operation. In this mode, the rod 9 with the contact element 12 go into a state of continuous forced oscillation, which provides a periodic closure of the DC circuit under the electrical contact between the parts 6 and 7 of the mechanical breaker 4 which are connected to the cathode 2 and anode 3 parts of the device, respectively.

The difference between the kinetic mechanical breaker shown in Fig.13 from the other ones (Fig.l 1, Fig.12) is that apart from the rod 9 and the contact element 12 the additional contact element 14 during the pulse mode of the device also goes into the state of continuous forced oscillation, but with a different period of natural oscillations. The presence of the additional contact element 14 and the ability to change its parameters as well as the parameters of the rod 9 and the contact element 12 allow to modify the frequency of closing and opening the DC circuit in a wider range of values.

When the action of the external mechanical force has stopped, the device switches into an intermediate mode of operation, in which the rod 9 with the contact element 12 are in a state of damped free oscillations due to the influence of the elastic forces, but they already have no electrical contact with the body 5. When the oscillations terminate, the device again switches to the non-operating mode.

The device with a gravitational mechanical breaker (Fig.14, 15) operates as follows.

In the non-operating mode of the device (Fig.14, Fig.15), the cathode and anode parts, connected in a DC electrical circuit, are closed to each other. Under the action of an external mechanical force, applied to the device during its operation, the inertial oscillating element 9 in the form of a ball goes into the state of continuous forced oscillation inside the cavity of the body 5, which state provides a periodic closure of the DC circuit via the contact pads 16 and a periodic interruption of the circuit when touching the inserts 17.

The device with a rotary mechanical breaker (Fig.16) works as follows.

In the non- working mode of the device (Fig.16), the cathode and anode parts, which are connected into the DC electric circuit, can be both closed and open. When the device goes to the pulse mode of operation, the inertial oscillating element 9 of the rotational mechanical breaker 4 is involved into rotation coaxially with the body 5, which leads to periodical closing and opening of the DC circuit by means of periodical touching the conductive contact pads 16.

An electromotive force generated between the cathode 2 and anode 3 parts of the device ensures the passage of microcurrent through body tissues (treating area of the device). In process of applying the device to the skin, the following effects are possible: pleasant tactile sensations, formication, local improvement of blood circulation, heating of the treated area. In process of using the device made in the form of a toothbrush or eating utensils, a sensation of sourness in the mouth is possible, which increases with an increase in the frequency of interruption of the galvanic couple. When the action of the device is combined with a use of non-invasive therapeutic and/or nutritional agents, an increase in the rate of penetration of the above agents through the tissues is observed.

To estimate the effectiveness of the electrostimulating effect of the direct current in the pulsed mode, an experiment was conducted, aimed to analyze the penetration of nicotinic acid through a human skin. Empirically, it was found that an increase in the frequency of interrupting the DC circuit leads to an increase in the rate of penetration of non-invasive therapeutic and/or nutritional agents into body tissues, and the resulted curve has the form of a power-law dependence (Fig.17). When determining said dependence, the frequency of interruption was set with a use of a potentiostat “Elins” P-20X, and to determine the rate of penetration of drugs, moments of reddening of a skin, which signaled the penetration of a test substance, were recorded with a use of a stopwatch. A reference drop of the substance was applied nearby, and it should be noted that during the part of the experiment with no electrical exposure, no reddening of the skin was observed.

Figure 17 shows the following points obtained during experiments with test prototypes of the claimed device comprising a mechanical breaker: point 18 - for the device in the form of a stick massager, point 19 - for the device in the form of a comb.

The range from 0.5 to 20 Hz (indicated by a box in Fig.17) is determined as the most preferable for practical applications, because at lower values the effect of the pulse mode is substantially not observed (the rate of penetration of non-invasive agents into body tissues decreases and tends to a speed of penetration under the action of direct current), whereas any attempts to provide a higher frequency by a mechanical converter involve significant technological difficulties, rapid wear of the device and a large increase in manufacturing costs due to the miniaturization of mechanisms. The frequency of interruption in said range can be varied by selecting geometric and physicochemical parameters of the elements of the breaker 4.

In accordance with polar law of Pfluger (B.I. Khodorov, General physiology of excitable membranes, M., 1975), it is the influence of direct current that provides a state of tissue excitation at moments of closing and opening the circuit. Therefore, the claimed device, which is based on a direct current pulse mode, is able to ensure a physiological impact of a special type. Taken in combination with the effect of galvanophoresis, this form of exposure allows to obtain new physiotherapeutic and organoleptic effects that are not available in case of using the known analogues of the device. The unit for breaking an electrical circuit is made in the claimed device in the form of a mechanical breaker, because the present state of the art does not allow to implement the breaker as an electronic breaker which would use the energy of the proposed variants of the galvanic couples without loss of electricity for the operation of the device: EMF 2.8 V, current strength 100 pA, power 0.28 W.

Thanks to the above design features, the proposed construction allows to significantly expand the functionality of the electrostimulating device. In addition, the use of the device in combination with non-invasive therapeutic and/or nutritional agents allows to increase the rate of penetration of said agents into body tissues due to the galvanophoretic effect (the higher the frequency of the pulsed mode and the greater the potential difference in the galvanocouple, the higher the rate of penetration).

Claims

THE CLAIMS

1. A device for non-invasive electrical stimulation of body tissues, comprising cathode and anode parts connected into a direct current electrical circuit and a unit for breaking said circuit, located therebetween, characterized in that the cathode and anode parts are made from materials having different electronegativity that form a galvanic pair, while the breaking unit is made in the form of a mechanical breaker equipped with a body and an inertial oscillating element configured to open and close the said circuit periodically under the action of external forces, wherein the body of the mechanical breaker is made hollow and the inertial oscillating element is located inside the body, wherein the body comprises conductive parts which are connected via a dielectric, provided that the mechanical breaker is of a kinetic type, but the body comprises conductive contact pads which alternate with dielectric inserts, provided that the mechanical breaker is of a gravitational or rotational type.

2. The device according to claim 1 , characterized in that it is configured to interrupt the circuit with a frequency of 0.5-20 Hz.

3. The device according to claim 1, characterized in that the galvanic pair produces an EMF of 0.4-2.8 V in the circuit.

4. The device according to claim 1 , characterized in that the cathode part is made from gold, platinum, silver, graphite or palladium.

5. The device according to claim 1, characterized in that the anode part is made from zinc, magnesium, lithium or alloys thereof.

6. The device according to claim 1 , characterized in that the device is made in the form of a dielectric blank, on which the cathode and anode parts are arranged in the form of a metal coating.

7. The device according to claim 1, characterized in that the body of the mechanical breaker comprises first and second conductive parts connected via the dielectric, wherein the first conductive part of the body is connected to the cathode part of the device, and the second conductive part of the body is connected to the anode part of the device.

8. The device according to claim 7, characterized in that the inertial oscillating element comprises a fixture element, a contact element and a rod connecting said elements, all of them are conductive, wherein the fixture element is connected to the first conductive part of the body, and the rod and the contact element are configured to involve periodically the contact element and the second conductive part of the body into contact with each other during oscillation under the action of external forces.

9. The device according to claim 8, characterized in that the fixture element and the contact element are made in the form of cone-shaped spirals with different maximum diameters, which apexes are connected to the rod.

10. The device according to claim 8, characterized in that the fixture element is made in the form of a cylindrical spiral, and the contact element is made in the form of a prolongation of the rod, curled into a spiral or ring.

11. The device according to claim 8, characterized in that a collar is arranged on the inner wall of the second conductive part of the body, a flexible resilient additional contact element is mounted on the collar, the element is configured to oscillate under the action of external forces and electrically isolated from the inertial oscillating element when these forces are absent.

12. The device according to claim 11 , characterized in that the additional contact element is made in the form of a cylindrical spiral.

13. The device according to claim 11, characterized in that a dielectric insert is located between the rod and the additional contact element.

14. The device according to claim 8, characterized in that the fixture element is made in the form of a prolongation of the rod, and the contact element is made in the form of a load weight.

15. The device according to claim 1, characterized in that the body of the mechanical breaker is made in the form of a hollow cylinder in which the inertial oscillating element in the form of a conductive ball is arranged, the diameter of the ball is less than the inner diameter of the cylinder and equal to the height of the cylinder cavity, wherein the conductive contact pads are arranged in the central part of the inner wall of the cylinder and alternatively connected to the cathode and anode parts of the device.

16. The device according to claim 1, characterized in that the body of the mechanical breaker is made in the form of a hollow outer cylinder, and the inertial oscillating element is made in the form of an inner cylinder located inside the outer cylinder with the ability of coaxial rotation, wherein the conductive contact pads are located on the inner wall of the outer cylinder and on the outer wall of the inner cylinder.