RU2279901C2 - Method and device for influencing bone tissue regeneration process - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: method involves concurrently exposing injured extremity segment to electromagnetic field produced by the first treatment unit manufactured as inductor and electromagnetic field produced by the second treatment unit manufactured as two inductors having self-sustained oscillators producing sinusoid oscillations having carrier frequency belonging to the bandwidth of 100-1000 kHz subjected to amplitude modulation with low frequency signal. The injured segment is concurrently treated with electric sinusoid current having carrier frequency belonging to the bandwidth of 1-300 kHz subjected to amplitude modulation with low frequency signal of continuously changing frequency in bandwidth of 4-100 Hz by means of electrodes. External fixation apparatus wires serve as the electrodes. The wires are brought through bone tissues in immediate vicinity of bone defect zone. High frequency oscillations of longitudinal and transverse electromagnetic fields action units are subjected to amplitude modulation with low frequency signal of continuously changing frequency in bandwidth of 50-8000 Hz. The procedure is applied twice a day within 20-30 min. Procedure lasts 20-40 min in daily mode. The cycle is 10-15 procedures long. The electric field optimum intensity is equal to 1,0-2,0 V/m and electric current intensity is equal to 20-30 mcA. Device has power supply source, the first tract having the first action unit manufactured as inductor included into oscillating circuit of the first self-sustained oscillator having the first tract control circuit composed of in cascade connected detector, DC amplifier and indicator lamp, the second tract having the second action unit manufactured as two inductors connected in cascade and in series and included into oscillating circuit of the second self-sustained oscillator having the second tract control circuit composed of in cascade connected detector, DC amplifier and indicator lamp, the first low frequency oscillator connected to the first and the second self-sustained oscillator circuits via appropriate modulators. The circuits produce sinusoid signal having carrier frequency in bandwidth of 100-1000 kHz. The third additional tract has self-sustained oscillator circuit having inductor having connection winding. An additional control circuit, containing in cascade connected detector, DC amplifier and indicator lamp, the second low frequency signal oscillator connected via additional modulator to self-sustained oscillator circuit of the third tract, is connected to self-sustained oscillator circuit. Connection winding outlets are connected to output leads of the third tract connected to the lower and upper disconnectable supporting metal rings of external fixation apparatus, each of which is manufactured as two insulated arcs connected to each other with connection members. The rings are connected with rods having three segments. The first and the third parts are fabricated as metal pins having external thread. The second one is dielectric bushing having external thread with metal wires being fixed thereon by means of fastening members and fixation control members.

EFFECT: enhanced effectiveness of treatment; accelerated treatment course.

4 cl, 5 dwg

Description

The invention relates to medicine, namely to traumatology and orthopedics.

A known method of stimulating the reparative regeneration of bone tissue by low-frequency pulsed exposure of the affected area of the limb using metal electrodes.

In osteoginesis, an external fixation device is used, the support rings of which are made of dielectric, spokes made in the immediate vicinity of the fracture zone are used as electrodes [1].

However, this method has limited therapeutic options.

Currently, the industry produces external fixation devices in which all parts are made of metal, which does not allow the use of spokes as electrodes [2].

The closest in essence is a method of stimulating reparative regeneration of bone tissue, the description of which is given in the patent of the Russian Federation No. 2221603 [3].

The method includes exposure in the postoperative period to a sore spot of a limb with an electromagnetic field, the source of which is an exposure element made in the form of a cylindrical inductor, the axis of which is directed along the limb. At the same time, the area of the bone defect is affected by an electromagnetic field, the source of which is the second exposure element, made in the form of two flat inductors, connected in series and according to which the axis is directed perpendicular to the limb.

Each of the impact elements is included in the oscillatory circuit of the corresponding oscillator. Self-oscillators form high-frequency sinusoidal oscillations, amplitude-modulated by a low-frequency signal.

However, in clinical practice there are cases when, during osteogenesis, a weakly expressed bone regenerate is observed, which leads to an extension of the treatment time.

The objective of the invention is to increase the efficiency of stimulation of reparative regeneration of bone tissue.

This is achieved by the fact that in the method of influencing the reparative regeneration of bone tissue, including exposure to the patient in the postoperative period, the limb site is simultaneously an electromagnetic field, the source of which is an exposure element made in the form of a cylindrical inductor, the axis of which is directed along the limb, and an electromagnetic field , the source of which is the second exposure element, made in the form of two flat inductors connected in series and according to of which the axis is perpendicular to the limb, with each of the exposure elements included in the oscillatory circuit of the corresponding oscillator, oscillators generate sinusoidal oscillations with a carrier frequency in the range of 100-1000 kHz, amplitude-modulated by a low-frequency signal, according to the invention, the sick area is simultaneously affected by an electric sinusoidal current from the carrier frequency in the range of 100-300 kHz amplitude-modulated low-frequency signal with a constantly changing frequency in the range of 4-100 Hz, at the power of metal electrodes, the role of which is played by the needles of the external fixation apparatus, drawn through bone tissue in the immediate vicinity of the bone defect zone, while the high-frequency vibrations of the elements of the longitudinal and transverse electromagnetic fields are amplitude-modulated by a low-frequency signal with a constantly changing frequency in the range of 50-8000 Hz , the procedure is carried out twice a day, the duration is 20-30 minutes, and the cycle is 10-15 procedures, the optimal value of the electric field strength for each of the exposure elements of 1.0-2.0 V / m, the optimal current value is 20-30 μA.

This is achieved by the fact that in the device for influencing the reparative regeneration of bone tissue, comprising an apparatus of influence, which contains a power source and two paths, the first path containing the first influence element, which is made in the form of a cylindrical inductor included in the oscillatory circuit of the first oscillator to the circuit of which a control circuit is connected containing a detector, a constant current amplifier and a light indicator connected in series, the second path contains a second element in the action, which is made in the form of two flat inductors connected in series and according to, and included in the oscillatory circuit of the second oscillator, to the circuit of which is connected a control circuit containing a series-connected detector, DC amplifier and light indicator, contains a low-frequency signal generator and two modulators in which the input terminals are connected to the output terminals of the low-frequency signal generator, and the output terminals are connected to the circuit of the corresponding oscillator, the impact elements are combined into a single functional unit, according to the invention, the impact device is equipped with a third path containing an oscillator circuit, in the oscillatory circuit of which an inductance coil is included, containing a coupling winding, the terminals of which are connected to the output terminals of the third path, an additional control circuit is connected to the oscillator circuit, containing connected in series with a detector, a DC amplifier and a light indicator, contains a second low-frequency signal generator and additional The additional modulator, in which the input terminals are connected to the output terminals of the second low-frequency signal generator, and the output terminals with the circuit of the third-channel oscillator, additionally contains an external fixation device containing supports in the form of metal rings, metal spokes, fastening and adjustment elements for fixing supports and knitting needles, rods for connecting the supports, while the external fixation apparatus all the rods for connecting the supports are made up of three parts, the first and third parts are made in the form of metal x stud with an external thread, and the second part is a sleeve of dielectric material with an internal thread elements joining metal parts of the supports comprise parts made of a dielectric material providing insulation of the metal parts.

The essence of the invention lies in the fact that in the method of influencing the reparative regeneration of bone tissue, including the exposure in the postoperative period to the affected area of the limb, simultaneously longitudinal and transverse electromagnetic fields, in which the magnetic induction vectors are mutually perpendicular, with the help of two exposure elements, simultaneously additionally high-frequency sinusoidal current, amplitude-modulated low-frequency signal using metal electrodes.

For this, an exposure pathway, the output terminals of which are connected to the electrodes, is additionally introduced into the device for the stimulation of osteoginesis.

The device includes an impact apparatus and an external fixation apparatus, which contains supports in the form of unlockable metal rings and rods for connecting the supports.

In the proposed method, the metal spokes of the external fixation apparatus, conducted through the bone tissue in close proximity to the area of the bone defect, are used as electrodes.

To isolate the electrodes from each other in the external fixation apparatus, additional parts made of a dielectric, for example, strips with two holes or a set of washers and cylindrical bushings, are introduced into the connection elements of the metal parts of the supports. At the same time, the rods for connecting the supports are made of three parts that are interconnected.

In this case, the first and third parts are made in the form of metal studs with an external thread, and the second part is made in the form of a sleeve of a dielectric with an internal thread.

Figure 1 shows a functional diagram of a device for influencing the reparative regeneration of bone tissue; figure 2 - apparatus of external fixation; figure 3 - support assembly with straps; figure 4 - bearing assembly with washers; figure 5 - rod for connecting the supports.

The apparatus for influencing the reparative regeneration of bone tissue comprises a first path 1, a second path 2, and a third path 3.

The first path 1 contains a first exposure element, made in the form of a cylindrical inductor 4, which is connected to the oscillator 6 through a capacitor 5. Coil 4 simultaneously acts as an influence element and an element of the oscillator circuit of the oscillator. The frequency of electromagnetic oscillations of the oscillator 6 is determined by the magnitude of the inductance of the coil 4 and the capacitance of the capacitor 5.

The path 1 contains a control circuit 7, which contains a series-connected detector 8, a DC amplifier 9 and a light indicator 10.

The second path 2 contains a second exposure element 11, which is made in the form of two flat inductors 12 and 13 connected in series and according to. The impact element 11 through a capacitor 14 is connected to the circuit of the oscillator 15.

The frequency of electromagnetic oscillations of the oscillator is determined by the total inductance of the coils 12 and 13 and the capacitance of the capacitor 14. The circuit of the oscillator 15 is connected to the control circuit 16, which contains a detector 17, a DC amplifier 18 and a light indicator 19.

The third path 3 contains a circuit of the oscillator 20, to which an oscillating circuit consisting of a capacitor 21 and an inductor 22 is connected. The coil 22 has a coupling winding 23, the terminals of which are connected to the output terminals 24 and 25. The frequency of electromagnetic oscillations of the oscillator 20 is determined by the magnitude of the inductance of the main winding coil 22 and the capacitance of the capacitor 21.

Coil 22 is made on an armored core B 26, core material M1500.

A control circuit 26 is connected to the circuit of the oscillator 20, comprising a detector 27 connected in series, a DC amplifier 28, and a light indicator 29.

The apparatus for influencing the reparative regeneration of bone tissue comprises a power source 30, a first low-frequency signal generator 31, a second low-frequency signal generator 32, a first modulator 33, a second modulator 34 and a third modulator 35.

At the modulator 33, the input is connected to the output terminals of the generator 31, and the output is connected to the circuit of the oscillator 6.

At the modulator 34, the input is connected to the output terminals of the generator 31, and the output to the circuit of the oscillator 15. At the modulator 35, the input is connected to the output terminals of the generator 32, and the output to the circuit of the oscillator 20.

The apparatus for influencing the reparative regeneration of bone tissue works as follows.

When the power source is turned on, the oscillators 6 and 15 generate sinusoidal oscillations, the carrier frequency of which is in the range of 100-1000 kHz.

At the same time, the first low-frequency signal generator 31 generates a signal with a constantly changing frequency in the range of 50-8000 Hz, which from the output of the generator 31 is fed to the inputs of the modulators 33 and 34, and then to the oscillator circuits 6 and 15.

The exposure element 4 forms an electromagnetic field in which the magnetic induction vector is directed along the limb. The field is formed by a sinusoidal signal with a carrier frequency in the range of 100-1000 kHz, an amplitude-modulated low-frequency signal with a constantly changing frequency in the range of 50-8000 Hz.

The impact element 11 forms an electromagnetic field in which the electromagnetic induction vector is perpendicular to the limb. The field is formed by a sinusoidal signal with a carrier frequency in the range of 100-1000 Hz, an amplitude-modulated low-frequency signal with a constantly changing frequency in the range of 50-8000 Hz.

The oscillator 20 generates sinusoidal oscillations in the range of 100-300 kHz, which are modulated in amplitude by the low-frequency signal supplied through the modulator 35 from the output of the second low-frequency signal generator 32.

Generator 32 generates a low-frequency signal with a constantly changing frequency in the range of 4-100 Hz.

At terminals 24 and 25, there is a voltage of a sinusoidal signal with a carrier frequency in the range of 100-300 kHz, amplitude-modulated by a low-frequency signal with a constantly changing frequency in the range of 4-100 Hz.

Impact elements 4 and 11 are combined into a single functional unit, the circuit elements of the first and second paths are also located there.

An embodiment of the block is given in the description of the patent of the Russian Federation No. 2221603.

Power supply 30, low-frequency generators 31 and 32, modulators 33, 54, 35, as well as circuit elements of the third path are structurally combined into a second functional unit.

Figure 2 shows the external fixation assembly, the figure shows only two support rings.

The apparatus contains an upper support ring, consisting of two metal arcs 37 and 38. The ends of the arcs are connected using connection elements. Figure 2 shows one of the options.

The composition of the connection elements includes washers 39, 40, 41, a cylindrical sleeve 42, a bolt 43 and a nut 44.

Parts 39, 40, 41 are made of dielectric.

Parts 43 and 44 are made of metal.

The complete arc 37 is isolated from the arc 38. Metal spokes 45 and 46 are fixed to the support ring using special bolts 47 and nuts 48.

The lower support ring, which contains metal arcs 49 and 50, connected by connecting elements, is similarly made. Spokes 51 and 52 are fixed to the lower support ring using special bolts and nuts.

The upper and lower support ring are interconnected by connecting rods 53, 54, 55 and 56.

Each connecting rod consists of three parts 57, 58 and 59. Parts 57 and 59 are made in the form of metal studs with external thread. Part 58 is made in the form of a sleeve with an internal thread of a dielectric. An embodiment is possible when parts 57 and 58 are pressed into part 58, which is made of press material, for example, AG-4B press material.

Figure 3 shows the connection of the arcs of the support ring using dielectric washers and bushings.

Figure 4 shows the connection of the arcs of the support ring using a strip with two holes, which is made of a dielectric.

Figure 5 shows the connecting rod.

The rod contains metal studs with external threads 57 and 59, which are screwed into a sleeve 58 made of a dielectric. To fix the studs 57 and 58, the rod is equipped with locknuts 60 and 61.

The proposed method for impacting the regenerative repair of bone tissue is as follows.

After the operation and installation of the external fixation apparatus, the procedure of stimulating the reparative regeneration of bone tissue is performed.

A device with exposure elements 4 and 11 above the area of a bone defect is mounted on a diseased limb. The limb is placed inside the element 4.

Conductors are connected to the output terminals 24 and 25, which are connected to the lower 37 and upper 49 support half-rings using the crocodile clamps at the second end. Turn on the power of the apparatus. The duration of the procedure is 20-30 minutes twice a day. A cycle of 10-15 procedures. The optimal value of the electric field strength at the surface of the exposure elements 4, 11 is 1-2 V / m. This value is set during the manufacture of the apparatus.

The optimal current flowing between terminals 24 and 25, 20-30 μA. This value is set during the manufacture of the apparatus.

After the procedure expires, the timer 62 disconnects the power from the generator circuits and turns on the sound indication 63. The presence of oscillations in the exposure elements 4 and 11 is controlled by the control circuits 7 and 16. The presence of a high-frequency voltage at the terminals 24 and 25 is controlled by the control circuit 26.

In the presence of oscillations and voltage, the light indicators 10, 19 and 29 are lit.

All windings of inductors are carried out by a wire of the LEPKO brand 20 * 0.07, the quality factor of each winding is at least 200 units.

The coil 22 is made on an armored core B 26, the core material is 1500 nm.

The presence in the device for stimulation of the external fixation apparatus of the proposed design allows you to control the process of bone formation according to the patent of the Russian Federation No. 2213519 [4].

The proposed method of influencing the reparative regeneration of bone tissue together with a device for its implementation allows you to create the most optimal mode of stimulation of reparative regeneration of bone tissue, accelerate the healing of soft tissue wounds. The greatest therapeutic effect is obtained in cases when there is a mild regenerate during osteoginesis.

The application of the proposed method in this case reduces the treatment time by an average of 40-50% compared with the generally accepted, while ensuring stable clinical remission.

Information sources:

1. VKKalnberz and others. The use of electrical stimulation to activate the process of bone fusion. Medical equipment. 1986, No. 2, pp. 13-19.

2. Copyright certificate of the USSR No. 538710 cells. A 61 B 17/18 Publ. 12/15/76, Bull. No. 46.

3. RF patent No. 2221603 class. 7 A 61 N 2/02 Publ. January 20, 2004 Bull. No. 2.

4. RF patent No. 2213519 class. 7 A 61 N 5/053 Publ. 10/10/2003, Bull. No. 28.

Claims (4)

1. A method of influencing the reparative regeneration of bone tissue, including exposure to a diseased limb in the postoperative period simultaneously with an electromagnetic field, the source of which is the first exposure element, made in the form of an inductance coil, and an electromagnetic field, the source of which is the second exposure element, made in the form two inductors connected in series and according to, with each of the elements of the impact included in the oscillating circuit corresponding of its oscillator, oscillators generate sinusoidal oscillations with a carrier frequency in the range of 100-1000 kHz amplitude-modulated by a low-frequency signal, characterized in that the affected area is simultaneously exposed to an electric sinusoidal current with a carrier frequency in the range of 100-300 kHz, an amplitude-modulated low-frequency signal with a constantly changing frequency in the range of 4-100 Hz using metal electrodes, the role of which is played by the spokes of the external fixation device, drawn through bone tissue in mediocre proximity to the area of the bone defect, while the high-frequency vibrations of the first and second exposure elements are amplitude-modulated by a low-frequency signal with a constantly changing frequency in the range of 50-8000 Hz, the procedure is carried out twice a day, the duration is 20-30 minutes, and the cycle is 10- 15 procedures, the optimal value of the electric field strength for each of the exposure elements is 1.0-2.0 V / m, the optimal current value is 20-30 μA. 2. A device for influencing the reparative regeneration of bone tissue, containing a power source, a first path including a first exposure element made in the form of an inductor included in the oscillatory circuit of the first oscillator, to the circuit of which a control circuit of the first path is connected, containing a detector connected in series, DC amplifier and light indicator, the second path, including the second exposure element, made in the form of two inductors connected by a follower but also according to those included in the oscillatory circuit of the second oscillator, the circuit of which is connected to the control circuit of the second path, which contains a series-connected detector, a DC amplifier and a light indicator, the first low-frequency signal generator connected through the appropriate modulators to the circuits of the first and second oscillators made with the possibility of generating a sinusoidal signal with a carrier frequency in the range of 100-1000 kHz, characterized in that the third path includes a self-oscillator circuit, in The oscillatory circuit of which an inductor containing a coupling winding is connected, an additional control circuit is connected to the oscillator circuit, which contains a series-connected detector, a DC amplifier and a light indicator, a second low-frequency signal generator connected through an additional modulator to the circuit generator of the third path, while the winding leads the connection is connected to the output terminals of the third path connected to the lower and upper supporting metal opening rings external fixation apparatus, each of which is made in the form of two arcs isolated from each other by connecting elements, the rings are fastened by rods made up of three parts, the first and third parts of which are made in the form of metal studs with external thread, and the second in the form of a sleeve of dielectric with an external thread, and on them by means of fastening elements and adjustment of fixation metal spokes are fixed. 3. The device according to claim 2, characterized in that the connection elements of the rings include strips with two holes from the dielectric. 4. The device according to claim 2, characterized in that the washers and bushings are made of dielectric.

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